Tamiflu Stop Flu

Severely Ill Patients With H1N1 Do Not Require Higher Tamiflu Doses

2010-02-26T01:10:00.000-08:00

Patients who are gravely ill with pandemic H1N1 influenza do not need a higher dose of oseltamivir (Tamiflu, Roche Laboratories), according to a study published online February 16 in the Canadian Medical Association Journal. The finding contradicts World Health Organization (WHO) dosing recommendations.
"Critically ill patients exhibit defects in gastrointestinal absorption because of impaired gut perfusion, edema of the bowel wall and ileus as a consequence of critical illness and shock," write Anand Kumar, MD, from the Department of Pharmacology and Therapeutics, University of Manitoba, Winnipeg, Canada, and colleagues. "Whether the enteric [intestinal] absorption of oseltamivir is impaired in such patients is unknown."
Researchers studied 41 patients (mean age, 41 years) who were admitted to 9 intensive care units in 3 cities in Canada and Spain, each of whom had respiratory failure believed to be caused by H1N1. All participants were using a ventilator, and 8 patients also had significant kidney disease. Of those 8 patients, 7 required dialysis, and 5 of the 7 needed continuous renal replacement therapy.
During the study period, most of the critically ill patients received the standard dose of oseltamivir, 75 mg 2 times a day — the same regimen as that of healthier subjects. In only a few instances did physicians administer the WHO-recommended double dose of 150 mg twice a day. Medications were taken orally or through nasogastric intubation.
Using tandem mass spectrometry, researchers evaluated plasma levels of oseltamivir free base and its active metabolite carboxylate. These assessments took place before the drug was given and at 2, 4, 6, 9, and 12 hours after a minimum of 4 doses.
Drug Concentration More Than Adequate
For the 36 patients not undergoing dialysis, the study resulted in the following findings:
Oseltamivir free base median plasma concentration was 10.4 μg/L, which is more than 2000- to 4000-fold higher than is necessary to restrain the virus.
The median concentration of the carboxylate metabolite was 404 μg/L.
Carboxylate metabolite's volume of distribution did not rise with increasing body weight (R2, 0.00; P = .87).
The elimination rate of oseltamivir carboxylate had a slight association with creatinine clearance estimations (R2, 0.27; P < .001).
In the 5 patients requiring continuous renal replacement therapy, drug clearance was about one sixth of that found in the other subjects.
"The dosage of 75 mg twice daily achieved plasma levels that were comparable to those in ambulatory patients and were far in excess of concentrations required to maximally inhibit neuraminidase activity of the virus," the authors write. "Adjustment of the dosage in patients with renal dysfunction requiring continuous renal replacement therapy is appropriate; adjustment for obesity does not appear to be necessary."
Limitations to the study included an inability to determine whether lung injury connected to severe pneumonia decreased oseltamivir penetration into pulmonary tissue, which could result in lower drug concentrations in the lungs. Researchers also noted that they did not evaluate the effect of antiviral density on the pulmonary viral load.
The study results are not conclusive, according to Donald Kennedy, MD, professor of infectious diseases, Saint Louis University School of Medicine, Missouri. In an interview with Medscape Infectious Diseases, he pointed out that researchers did not address whether increasing the dose to 150 mg might change outcomes.
"They didn't study the double dose in sick people; they studied the regular dose in sick people," Dr. Kennedy said. "What they showed is the regular dose in sick people appears to give the same levels as the regular dose to people in the original Tamiflu studies, which were relatively healthy people." Dr. Kennedy was not involved in the study.
r. Kumar told Medscape Infectious Diseases that he is currently presiding over a larger study to test the 150-mg dose.
"There are still other reasons why higher doses may be helpful," Dr. Kumar said. "We hope we'll have a definite answer to this in a year or two."
WHO Will Consider Changes to Dosing Recommendations
Nikki Shindo, MD, medical officer, Epidemic and Pandemic Alert and Response Department, WHO, Geneva, Switzerland, called the study "thorough and sound." Although she would prefer to see the results replicated first, Dr. Shindo said WHO will take the findings into account for new guidelines to be released in July.
"I think we can count it as very important evidence that will impact our recommendations. If the results are proven elsewhere in the world, that will increase its strength," Dr. Shindo said in an interview with Medscape Infectious Diseases.
Dr. Kumar said that he is aware of several studies attempting to replicate his results. He is optimistic that further research will confirm his findings.
"It's a very simple study. You give the patient the drug, you measure it in their blood, and assuming that the assay is accurate and this was done by a commercial laboratory, you would get similar results," Dr. Kumar said. "There is not a lot of wiggle room or expectations that you would see anything substantially different."
The Public Health Agency of Canada and Hoffmann-La Roche, manufacturer of Tamiflu, supported this study. Dr. Anand Kumar is leading another study of H1N1 and oseltamivir therapy that is also supported by Hoffmann-La Roche, and coauthor Dr. Stéphane Ahern is president of the Comité scientifique de l'inscription, Conseil du médicament du Québec, an advisory committee. The study authors have disclosed no other relevant financial relationships.

Putting Tamiflu To The Test

2010-02-26T00:58:00.000-08:00

The efficiency of influenza virus drugs, such as Tamiflu, can now be tested thanks to equipment at the University of Canterbury.
The research will be carried out in the University's world-class Biomolecular Interaction Centre (BIC) laboratory in collaboration with Environmental Science & Research (ESR) and the National Centre for Biosecurity and Infectious Disease.
This research project is possible thanks to specialist state-of-the-art equipment and new BioRad certification as a reference lab.
"Central to our equipment is the surface plasmon resonance (SPR) that we got from BioRad," said BIC Co-director Professor Conan Fee (Chemical and Process Engineering).
UC was the first in the southern hemisphere to buy a BioRad SPR ProteOn XPR 36 which is used to determine the specificity, affinity and kinetics of the interactions of biomolecules. The SPR also enables researchers to focus on testing scientific hypothesis rather than driving the instrument.
Professor Fee said that it had some "nice features, essentially it allows us to do a lot of research, get many results and very quickly".
Using the SPR, anti-viral drugs such as Tamiflu will be tested for efficiency in combating strains of influenza.
"Where the influenza virus mutates and becomes resistant to medication, we are developing new methods by which we can explore those mechanisms - this is a project that has come to us directly because of SPR," Professor Fee said.
"We aim to test this in our instrument to see if anti-viral drugs work or the viruses have developed resistance."
Another collaboration includes research with the Wakefield Gastroenterology Centre in Wellington.
The Wakefield Gastroenterology Centre approached BIC directly as a result of having the SPR and since has developed a collaboration looking at type 2 diabetes. The research is looking at the relationship between gastric bypass surgery and the disappearance of insulin resistance in diabetic patients.
"Professor Richard Stubbs [gastric by-pass surgeon and Adjunct Professor at Otago University's Wellington Clinical School of Medicine] came to visit UC to offer a library of blood and serum samples from gastric bypass patients," said Professor Fee.
"They are going to provide the samples and we will look at the reactions between insulin and its receptor using the SPR looking for factors and the mechanism of why diabetics' symptoms switch off after gastric bypass surgery."
BIC also has collaborations with Plant and Food, Lincoln University, the University of Otago Christchurch School of Medicine, AgResearch and more recently Industrial Research Ltd and Fonterra.
"BIC is working well with new collaborations, even in its early stage, and we are all very enthusiastic," said Professor Fee.

When swine flu pandemic hits home

2010-02-18T06:20:00.001-08:00

By Steve Sternberg, USA TODAY
Joan Bishop's thoughts trend toward disaster. Earthquakes, hurricanes, "dirty bombs," weapons of mass destruction, killer pandemics — she has studied them all.
But Bishop, 46, of Fairfax, Va., says her expertise did little to stop the H1N1 pandemic from landing on her doorstep. Despite taking all the recommended precautions, two of her three daughters, Beri, 10, and Bailey, 13, contracted swine flu. Each posed a different challenge because their unique risks — Beri's autism and epilepsy and Bailey's asthma — made them more difficult to treat.
H1N1 AND KIDS: Swine flu strikes most vulnerable hardest
INTERACTIVE: Swine flu map, flu IQ quiz, video and latest news
What's more, Bishop says, her expertise intensified her concerns about her children.
"I know too much," she says.
The worst-case scenarios
A disaster preparedness expert for the consulting firm Booz Allen Hamilton, Bishop has helped draft pandemic plans for the Department of Defense and the Department of Health and Human Services. She has absorbed the medical literature and studied the case histories.
As her children grew sicker, she was overwhelmed with anxiety over what might happen next. She couldn't shake the worst-case scenarios that were running through her mind.
"I knew what was happening medically. I've read the autopsy reports. Seeing those was scary," she says.
The Bishop family's ordeal illustrates one of the central paradoxes of the pandemic. Unlike seasonal flu, H1N1 has taken a disproportionate toll on children.
Beri's symptoms set in on Nov. 1, when H1N1 vaccine was still in short supply. Right after Halloween, Beri developed a high fever and respiratory symptoms.
Her pediatrician diagnosed Beri with flu complicated by pneumonia. She prescribed antibiotics and the antiviral drug Tamiflu. But Beri, who already was taking medication for seizures and an inactive thyroid, was gripped with anxiety about taking any more pills.
"She was paralyzed with fear of choking, because she was coughing so much," Bishop says.
Her parents' urging to follow the doctors' orders hardened her resistence. Soon she refused to take any medication at all. "I was stressed that she was not taking her antiviral and antibiotics," Bishop says. It was Beri's refusal to take her anti-seizure medication "that almost did me in," her mother says. "You can't have a seizure on top of this," she implored her daughter.
Her parents tried liquid Tamiflu, Bishop says, but that didn't help: "It tasted like gasoline." The usual advice — "put it in applesauce" — didn't work. Ultimately, she ended up washing the drug down with big gulps of cola. She still refused to take her antibiotics, so doctors began giving them to her intravenously and through injections. Eventually, the medicine helped, and Beri began getting better.
Then, in the first week of December, back from a family vacation in California, Bailey got the flu, complicated by an ear infection.
She was diagnosed on Sunday, Dec. 6. Doctors prescribed Tamiflu and antibiotics. By Wednesday, Bishop says, her father took Bailey back to the doctor. "She was having severe symptoms for someone who had been on Tamiflu for four days." A chest X-ray was negative.
Bailey's ordeal worsens
By Friday, Dec. 11., Bailey's temperature hit 103 degrees and stayed there. She began coughing so persistently that she couldn't sleep. In the early hours of Dec. 12, her parents took her to an urgent-care center because she couldn't breathe. A doctor prescribed oral steroids, drugs known to ease airway congestion.
Based on a new chest X-ray, Bishop says, the doctor diagnosed pneumonia. But three subsequent X-rays and a CT scan of Bailey's chest proved inconclusive. One clue to Bailey's misery may lie in the autopsy research Bishop cites.
The studies, by Jeffrey Jentzen at the University of Michigan and James Gill of New York University and Jeffrey Taubenberger of the National Institute of Allergy and Infectious Diseases, show that unlike most flu viruses, H1N1 can settle deep into the lungs. "We're not sure why," Jentzen said in a recent interview.
A new crisis began on the morning of Christmas Eve, after a visit with Santa Claus at a local mall. Bailey began wheezing, and despite treatments with nebulizers at home, her blood oxygen level began dropping. A doctor recommended that Bailey be admitted to Inova Fairfax hospital, where she stayed for two days.
Since then, she has been sustained on steroids, given orally and through inhalers. "She's better than she was, but she's not back to her full capacity," Bishop says. "Her asthma is worse than before."
Doctors allowed Bailey to stop taking the oral steroids in January. She is slowly getting better, Bishop says, but it may be months before she fully recovers.

Increased Tamiflu dosage not necessary for critically ill H1N1patients

2010-02-18T05:50:00.000-08:00

Washington, DC: A new study has found that a high dosage of Tamiflu (oseltamivir) for patients with critical illness is unlikely to be required for the treatment of pandemic (H1N1) influenza. The study has appeared in Canadian Medical Association Journal (CMAJ).
The study goes against the World Health Organization (WHO) guidelines, which say all critically ill patients should be treated with Tamiflu and if the patient was unresponsive to standard doses, or critically ill, a higher dose should be considered. As critically ill patients may have gastrointestinal absorption issues, guidelines suggest higher doses of Tamiflu.
The CMAJ study looked at the gastrointestinal absorption of Tamiflu in 44 patients, 18 years of age or older, with suspected or confirmed pandemic (H1N1) influenza who were admitted to nine ICUs in the two Canadian cities of Winnipeg and Ottawa and Tarragona, Spain, because of respiratory failure.
"Studying the absorption ability of Tamiflu in the critically ill became a priority with the large number of patients needing ICU and ventilation support,"
Lead author Dr Anand Kumar, Health Sciences Centre, University of Manitoba and coauthors, write: "Also, the number of obese patients suffering from H1N1 related critical illnesses were large which raised the question about whether the dose should be adjusted upwards with increased body weight."
Blood sampling suggested that the 75 mg twice daily dosage of Tamiflu was well absorbed in critically ill patients with respiratory failure. Blood levels of the antiviral were similar or higher than levels in ambulatory patients with a similar dosage. Patients with kidney dysfunction requiring dialysis needed an adjusted dose but adjustment for obesity was not required.
The authors conclude: "The findings of this study suggest that an increased Tamiflu dosage is unlikely to be necessary in such cases based on either insufficient drug absorption or altered distribution pharmacokinetics."

Genentech deal, Tamiflu sales lift Roche

2010-02-11T04:46:00.000-08:00

ROCHE Holding reported an 11% increase in second-half profit yesterday, helped by cost savings from its takeover of Genentech and higher demand for swine flu drug Tamiflu.
Profit excluding some costs advanced to Sf4,59bn (4,35bn) from Sf4,15bn a year earlier. Fourth-quarter revenue rose 2,8% to Sf12,65bn, Roche said. That fell short of expectations, according to Birgit Kulhoff, an analyst at Rahn & Bodmer in Zurich.
While Roche benefited from greater than expected Tamiflu demand, which soared as the H1N1 virus spread, sales of the company’s cancer medicines, Rituxan and Herceptin, declined in the fourth quarter, falling short of analysts’ forecasts. It said that performance was affected by wholesalers reducing inventory and was not “a prediction into 2010”.
Numbers from January showed a “healthy trend”, chief financial officer Erich Hunziker said yesterday.
Roche, based in Basel, Switzerland, maintained its forecast that earnings per share excluding some items would probably rise at a double-digit pace this year at constant exchange rates.
Revenue was expected to grow in the mid-single-digit range in local currencies this year. The outlook excludes sales of Tamiflu. Roche said it would maintain its dividend policy.
The shares fell Sf2,4, or 1,3%, to Sf178,2 before midday yesterday in Zurich trading. Roche has risen 9,7% in the past year, compared with a 12% gain in the Bloomberg European pharmaceuticals index.
Roche CEO Severin Schwan dismissed speculation that Novartis could sell its stake in its rival to help pay for acquiring eyecare group Alcon, telling CNBC the talk was “pure speculation”.
The Swiss drug maker repeated that it was targeting savings of Sf1bn a year by next year from the 46,8bn purchase of Genentech.
Roche expects to repay 25% of the debt raised to finance it by the end of this year and to “return to a net cash position” by 2015.
Revenue from Tamiflu has risen since the outbreak of swine flu in April. The medicine generated Sf3,2bn in sales last year, more than the company’s October estimate of about Sf2,7bn. Tamiflu was likely to generate about Sf1,2bn in sales this year, Roche said yesterday, up from an earlier estimate of Sf700m.
Sales of the medicine, which has been shown to ease the symptoms of infection with the virus, generated Sf1,2bn in revenue in the fourth quarter, compared with Sf181m a year ago.
The H1N1 virus had been confirmed in more than 209 countries worldwide and had caused at least 14711 deaths as of January 29, the World Health Organisation (WHO) said last week. Swine flu causes little more than a fever and cough in most cases. WHO director-general Margaret Chan said recently that the worst may be over in the northern hemisphere. Bloomberg

Tamiflu sales boost Roche profits

2010-02-11T04:43:00.000-08:00

Swiss drugs firm Roche has reported an 8% rise in annual sales, helped by sales of swine flu drug Tamiflu and cancer treatments, such as Herceptin.
The rate of growth is twice the industry average and operating profits were up by 14% to 15bn Swiss francs ($14.2bn, £8.89bn).
However, overall net income for the year fell 22% to 8.5bn Swiss francs as a result of takeover costs.
Last year, Roche bought US pharmaceutical giant Genentech.
It says that this deal is already proving profitable.
Although sales of Tamiflu soared last year, they are expected to fall sharply in 2010, to 1.2bn Swiss francs from 3.2bn Swiss francs in 2009.

Scientists Develop Cheaper Version Of Tamiflu

2010-01-23T01:58:00.000-08:00

Tamiflu has emerged as one of the preferred weapons in the battle against flu, both seasonal and the H1N1 virus, but it has at least one drawback -- it tends to be costly.
But a group of scientists claim to have developed an alternative method for producing the active ingredient in Tamiflu. The new process could expand availability of the drug by reducing its cost, which now retails for as about $8 per dose. Their study is in ACS' Organic Letters, a bi-weekly journal.
Anqi Chen, Christina Chai and colleagues note that the global pandemic of H1N1 has resulted in millions of infected cases worldwide and nearly 10,000 deaths to date. Tamiflu, also known as oseltamivir phosphate, remains the most widely used antiviral drug for the prevention and treatment of H1N1 infections as well as bird flu and seasonal influenzas.
But growing demand for the drug has put pressure on the supply of shikimic acid, the raw material now used in making the drug.
"As a result, chemists worldwide including ourselves have explored the possibility of using other alternative raw materials for the synthesis of the drug," said Chen and Chai, who led the research.
The scientists describe a new process for making the drug that does not use shikimic acid. They found that D-ribose, a naturally-occurring sugar produced by fermentation in large scales, potentially provides an inexpensive and abundant source of starting material for making the drug. D-ribose costs only about one-sixth as much as shikimic acid.
In lab studies, the scientists demonstrated the potential use of D-ribose as an alternative source for the synthesis of Tamiflu.
Tamilflu is not a vaccine against flu, but rather an antiviral, used to treat effects of the flu. Patients who take Tamiflu after, or just before getting the flu reportedly have less severe symptoms and recover more quickly.
However, critics say Tamiflu is not nearly as effective against flu symptoms as its manufacturers claim.

Public Citizen questions effectiveness of Tamiflu

2010-01-23T01:47:00.000-08:00

Tamiflu, the anti-flu drug being taken in record amounts, doesn't prevent serious complications from the flu and shouldn't be used for routine control of the flu in healthy adults, according to Public Citizen.
Public Citizen, a consumer advocacy organization, has called for an independent review of raw data from clinical trials funded by Tamiflu's maker, Roche.
The company has claimed that the drug dramatically reduced hospital admissions as well as bronchitis and pneumonia. But, a recent investigation by the British Medical Journal and British TV Channel 4 concluded that such claims were meritless.
With of widespread media coverage of the H1N1 virus, Tamiflu sales have skyrocketed. In October, 2.5 million prescriptions were filled in the U.S. compared to 35,000 prescriptions in October 2008. During 2009, 6.8 million prescriptions were written, compared with 4.3 million in 2008.
All the clinical research conducted to determine the effectiveness of Tamiflu on healthy adults has been funded by Roche.
The British investigation involved a review of published studies examining the effects of Tamiflu in preventing serious complications of the flu in otherwise healthy adults. The authors concluded that Tamiflu shouldn't be used in routine control of seasonal influenza. They also were concern about underreporting of side effects of the drug.
For more information for boomer consumers, see my blog The Survive and Thrive Boomer Guide.

Brit woman becomes blind after taking Tamiflu

2010-01-22T14:03:00.000-08:00

A National Health Services helpline advised Samantha Millard to take the medication, and within 72 hours Millard was in the hospital on life support.
Millard, from Bicester in Oxfordshire, England, has developed Stevens-Johnson syndrome that causes skin to peel off.
She is also suffering from toxic epidermal necrolysis syndrome, which has made her visually impaired.
Tests have revealed she never had the H1N1 virus.
According to the doctors, it could take up to two years for Millard to recover, and they are not sure if her eyesight will return.
"It's hard," Fox News quoted Millard as saying.
"I can't bathe myself, I can't dress myself, I can't watch films and I can't read books," she added. (ANI)

Tamiflu-resistant swine flu is here

2010-01-11T02:41:00.000-08:00

A kidney transplant patient in WA has died after developing Australia’s first case of H1N1 pandemic influenza resistant to oseltamivir (Tamiflu).
However, the virus still appears to be to be sensitive to zanamavir (Relenza) says Dr David Speers, Infectious Diseases Physician at the Sir Charles Gairdner Hospital in Perth, in a case report in the MJA today.
Dr Speers and colleagues say their patient initially became infected with wild-type H1N1 influenza after undergoing a renal transplant and while taking immunosuppressant drugs.
After a 10-day course of oral oseltamivir the patient developed rapid-onset severe primary viral pneumonia due to oseltamivir-resistant virus, and respiratory failure progressed despite high-dose oral oseltamvir and nebulised zanamivir.
The patient improved and became negative for influenza after being treated with intravenous zanamavir but subsequently died from intraperitoneal sepsis.
The report’s authors say the resistant virus contained the H275Y NA mutation, which is the major mechanism for oseltamivir resistance in influenza. Until now most of the 31 cases of resistance reported worldwide have occurred in people taking oseltamivir as post-exposure prophylaxis, they note.
They say the patient developed the resistant strain a few days after stopping his initial course of oseltamivir, “possibly due to declining blood and tissue levels of the antiviral drug”.
They conclude by saying that intravenous zanamivir may prove to be a useful antiviral therapy for severely unwell influenza patients, including those with oseltamivir-resistant pandemic (H1N1) 2009 infection.

Antiflu drug flows into rivers during flu season

2010-01-05T02:49:00.002-08:00

Scientists report they found the anti-viral medication Tamiflu in rivers in Japanese cities during last year's flu season. Tamiflu is an antiviral drug used to slow the spread of the influenza, or flu, virus by both treating and preventing influenza, including H1N1 and avian flu (H5N1). The contamination raises serious public health safety concerns about the overuse of antiviral drugs that may lead to development of Tamiflu-resistant flu strains. The results highlight a need for enhanced treatment of wastewater, especially during periods of elevated flu risk.What did they do?
Researchers from Kyoto University in Japan sampled water from several rivers and treated sewage effluent that was released into the rivers prior to and during the 2008-09 flu season. The samples were analyzed for levels of the popular antiviral medicine OC.
Samples taken between June and October of 2008 represent the non-flu season. The flu season samples were collected during three outings – one in December 2008 and two in February 2009 – from 11 locations along the Katsura River and several of its tributaries. The Katsura River system receives more than 80 percent of the wastewater from Kyoto City – a city of more than 1.3 million people.
The water samples were analyzed for the drug using a new method developed by the research team. Amounts in the river water and effluents were then calculated and compared.
What did they find?
OC was not detected in samples taken prior to the start of the flu season.
It was found in all of the sewage treatment plant discharges that were examined during the three sampling campaigns taken during flu season. Concentrations of up to 293.3 nanograms/liter (ng/L) were measured in water collected from sewage outflows.
It was also detected in river water downstream of the sewage treatment outflows. Levels ranged from 6.6 to 190 ng/L in river water samples.
The OC concentrations varied with the level and type of sewage treatment used. Sewage treated with a more stringent process called ozonation had lower concentrations of OC. With higher treatment, levels were reduced up to 85 percent and measured at 37.9 ng/L when compared with a less efficient type of sewage treatment called activated-sludge.
What does it mean?
OC was found in all sewage treatment plant discharges for all sampling times during the flu season in this study. In some cases, OC was found in appreciable quantities. OC is the active metabolite of the anti-flu medicine Tamiflu.
This is the first study to identify OC in sewage treatment plant discharge during flu season. The results suggest that standard sewage treatment is not effective at removing the OC residue from sewage.
Wildlife – including waterfowl that can transmit the flu – are exposed to the low and continuous doses of OC during the flu season. This exposure increases the likelihood that an OC resistant virus strain could develop and be picked up by the waterfowl that congregate at sites of sewage effluent discharge. Waterfowl and other birds are identified as animals of high concern in the transmission of new strains of flu virus to humans.
H1N1 has reached pandemic status and is becoming resistant to Tamiflu – which is a critical first line of defense in flu treatment.
A serious question raised by the study's findings is whether Tamiflu should be dispensed so widely during flu season. Its widespread use could increase the risk of drug resistant flu strains that are currently untreatable. If the drug is doled out sparingly, many people will be at increased risk for dangerous complications from the flu.
The scientists reported a bright side, however.
Sewage treatment plants that incorporate ozone into their treatment processes had much lower concentrations of OC than those without ozone. Although ozone increases the cost of sewage treatment, this study highlights an important reason to mandate the use of ozone in sewage treatment processes, at least during flu season.

Context
In the United States, approximately 36,000 people die and more than 200,000 are hospitalized every year after they get sick from influenza, also called the flu. Certain viral strains – such as H1N1 (swine flu) – may cause more illness or more severe illness than other strains (CDC 2009).
The H1N1 virus is unique in that it is responsible for the first flu pandemic (global outbreak of disease) in more than 40 years (World Health Organization 2009a). Pandemics are thought to occur when a new strain of flu virus is transmitted from animals to people. Birds, chickens and pigs can transmit flu strains to humans, and health experts consider these animals to be the biggest concern.
Antiviral drugs, such as Tamiflu, can decrease the severity of symptoms and the duration of the flu. The drugs can also prevent other serious health complications associated with the flu and are considered a critical line of defense in the battle against flu viruses.
The active ingredient in Tamiflu is a drug called oseltamivir phosphate (OP). OP can be converted in the body and discharged in the urine as another compound called oseltamivir carboxylate (OC). More than 80 percent of the oral dose of OC is excreted unchanged.
Most sewage treatment plants do not remove antiviral medications from the wastewater. The drugs end up in rivers, streams and other water bodies where the effluent is released. Anti-flu medications in the environment can interact with flu viral strains that are also in the water, promoting strains that are not affected by Tamiflu and increasing the likelihood that new, drug-resistent strains will develop in the areas near where sewage dumps into surface waters.
Health officials worry that the widespread use of OP to fight seasonal influenza in humans could lead to the development of OC-resistant strains of the viruses in wild birds.
Many subtypes of the flu virus are transmitted through waterfowl. The microbes incubate in the birds and are then excreted in the bird droppings.
Waterfowl often remain close to sewage treatment discharges, since the water temperature is warmer and food is more plentiful. These habits can put them in direct contact with resistant strains of the flu virus, where they can infect waterfowl and be passed to other wildlife and possibly people.
Health experts have already noted an increase in resistance of the H1N1 virus to Tamiflu – a finding that has raised concern about the widespread use of Tamiflu in treating seasonal flu outbreaks

Woman protects unborn baby from H1N1 with Tamiflu

2010-01-05T02:49:00.001-08:00

At two-months pregnant and possibly infected with H1N1, Jordana Simms decided to take the anti-viral Tamiflu to protect her and her unborn child.
Sick in early November, while public debate whirled around the safety of drugs to deal with the influenza pandemic, the Sylvan Lake resident was scared.
“I’ve had a few friends who opted just to suffer it out just because they were past what they figured was the worst part.
“There’s enough complications in the first trimester, so I wasn’t going to risk it,” said the mother of two.
Two days later Simms, 23, was on the mend, and an ultrasound showed her unborn baby was fine.
With the third H1N1 wave expected this winter, Simms is not afraid to share her opinion on antivirals, a hot topic on message boards and birth clubs online.
“If you trust your doctor, listen and take their advice because that’s the only thing that got us through. If I had sat on the fence any longer who knows what could have happened,” said Simms about the danger of flu complications for women and their fetuses.
“Trust your gut.”
Alberta Health Services recommends Tamiflu or Relenza for all pregnant women who develop influenza-like symptoms in their second and third trimesters or within four weeks after giving birth.
Immunization is also recommended.
At first Simms and her doctor thought it was just a bad cold or flu.
“I just laid out on the couch. I couldn’t move. I was having a hard time breathing. Everything felt swollen. I couldn’t open my eyes. I just felt horrible.”
But by the second night her husband Tom Simms could hear her straining to breath.
“It felt like someone was sitting on my chest.”
That night they went to the emergency department at Red Deer’s hospital. She was given a prescription for Tamiflu and before she filled it the next day, she called her doctor who said it was time to take the drug.
Simms is due to give birth June 18.
Twelve people with flu-like symptoms visited Red Deer’s emergency ward between Dec. 21 and 27.
Alberta Health Services will continue to hold public immunization clinics in the new year. None have so far been scheduled for Red Deer.
As of Dec. 23, a total of 108,450 people have been immunized at AHS clinics in Central Alberta.

Swine detected in 5 doctors, army officer in JK

2010-01-03T23:08:00.000-08:00

Eight more cases of swine flu have been detected in Jammu and Kashmir, including five doctors and an army officer, taking the total number of infections in the state to 64, the state Health Department said here today.
Eight persons, including five doctors and an army officer, have tested positive for H1N1 virus, department officials said after receiving reports from the National Institute of Communicable Diseases (NICD).
They have all been put on Tamiflu and their condition is stated to be stable, Dr Nasarullah Hussain, Nodal officer for swine flu matters the Kashmir valley, said.
So far, four persons have died due to swine flu in Jammu and Kashmir.

Hong Kong reports 53rd death related to new flu

2010-01-03T23:04:00.000-08:00

Hong Kong Hospital Authority announced Sunday that a 49-year-old male patient with a history of diabetes and obstructive sleep apnea syndrome died earlier after he was confirmed to have contracted the A/H1N1 flu, becoming the 53rd person in the city claimed by the epidemic.
The patient was admitted to the United Christian Hospital on Dec. 22 with fever and other flu-like symptoms, since when he has been on ventilation support. He was prescribed with Tamiflu and antibiotics. The patient's condition became critical and was transferred to the intensive care unit on Dec. 23.
According to a spokesman of the hospital, the patient tested positive for the A/H1N1 flu on Dec. 24 and finally succumbed on Jan. 2.

Year of pandemic and tragedies

2009-12-31T02:05:00.000-08:00

Health Correspondent Marie-Louise Connolly gives her prognosis on an extremely busy year for the health service.
It was the year when a pandemic hit and most of us survived to tell the tale.
The first news of swine flu flashed up on the news channels on Friday 24 April shortly after 4pm on a sunny afternoon.
The facts were sparse but the reality of what was happening in Mexico was shocking.
It was reported that there had been an ongoing epidemic since March, but it was only recognised as a highly contagious virus several weeks later when it began spreading between people and eventually across borders.
The Mexican government closed most of Mexico City's public and private facilities in an attempt to contain it, but it did spread globally and in June the World Health Organization stopped counting cases and declared a pandemic.
BBC Northern Ireland reported the first local swine flu case on Thursday 14 May.
Within days, the phrase "catch it, bin it, kill it" had become familiar as had the anti-virals, Tamiflu and the warning to "stay at home".
On 20 August, a woman with "underlying health problems" was the first to die from swine flu in Northern Ireland.
To date 13 others including adults and children have died and almost all of them had underlying health problems.
While the word pandemic is frightening, as most of us have experienced, its impact is less dramatic.
The Department of Health, very quickly and efficiently took control of the situation - the information provided at those initial press conferences was very much on a need to know basis.
The vaccination programme was rolled out on 21 October, with health service workers among the first to be vaccinated.
There were demands for children with underlying health problems to be vaccinated sooner, especially when two children from the same special needs school died with the virus.
At that stage, teachers in special schools were not to be included in the programme.
However, after a very public outcry from some school principals, a few days later and in a complete u-turn, the health minister, Michael McGimpsey, announced that staff at such schools would receive the vaccine.
The Department of Health received a lot of criticism for its "knee-jerk" reaction. However, within 48 hours, the policy was adopted by its Scottish counterpart.
For the sixth consecutive week there has been a decrease in the number of cases of swine flu, the number of admissions to hospital and those dying from the virus.
While this is all positive, many politicians and health professionals are questioning whether it was all a lot of hype with the government having to pick up a hefty bill to reassure the public.
In response to this criticism, the health minister said it's a case of damned if he did and damned if he didn't.
Speaking of bills, the minister is constantly crying poverty and at every opportunity putting out the begging bowl on behalf of his department.
There is no doubt, that Northern Ireland's health service is in dire need of a cash injection. But then again so are so many of the other departments. The Health Department is expected to make £700m in efficiency savings.
This will have an impact on attempts to improve services including mental health, any new builds, including a new mother and children's wing at the RVH and the postponement of services including the bowel cancer screening programme until April.
The minister has admitted that paying for swine flu has had an impact on other services.
And the future situation is not looking any brighter. With water charges not being introduced there is a massive shortfall in the executive's budget.
The Department of Health could be looking at having to make an additional £150m in savings.
One lasting image of the year will be Mr McGimpsey's face among the crowd attending a rally against health cuts.
Despite wearing a traditional "workman's cap", it didn't disguise the fact that in some ways he was demonstrating against himself.
Whether his presence will help cushion the blow when those cuts are made in a "I did lend my support to you at the time" type scenario, will all depend on his relationship with the health unions.
According to some members of the assembly's health committee this won't be a problem. The DUP's Iris Robinson has on many occasion alluded to their "cosy relationship" and that one is working on behalf of the other.
Strike warning
Unison's Patricia McKeown gave a sobering message to politicians at Stormont.
"This is the start of something and it will get bigger. But, if we are not listened to, and I say this very clearly on behalf of Unison, the next time we are here it will not be on our own time, it will be on strike," she said.
There have been many other challenges along the way. The regulatory Body the RQIA delivered a few blows of it's own on the cleanliness of hospitals.
All of the local acute hospitals failed in delivering a high standard of cleanliness. Ward F in the Royal Victoria Hospital had to be closed as it failed to reach the minimum compliance level.
On the issue of child protection services the year is ending on a particularly tragic note.
Following the inquest of the McElhill tragedy in Omagh, in which the father of five was found to have set fire to his home killing his partner and children, there came the death of Millie Martin.
Aged 15 months, Millie, who was from Enniskillen, was so badly beaten she died from her injuries.
Millie and her mother Rachel had been seen by a health visitor when Millie was a few months old but according to her mother was not known to social services.
The McElhill family, however, was known to social services and other statutory agencies including the police.
Henry Toner, who carried out a review into the Western Health Trust is to revisit some time in the new year to ensure his 63 recommendations are being properly implemented.
These tragedies, particularly that of little Millie Martin, will undoubtedly spill over into 2010.

H1N1 costly in more ways than one

2009-12-30T23:00:00.000-08:00

Last month at Total Health Care Pharmacy in Bolton I picked up two prescriptions for the H1N1 antibiotic - Tamiflu. They charged $114 for my daughter’s medicine and $65 for mine. Unbeknown to me, it was free to the public. Apparently pharmacies can submit the costs directly to the Government of Ontario. If not for a friend's knowledge, I would still be out of pocket $180. Total Health Pharmacy has since refunded my money.
H1N1 flu was costly in more ways than one. Being a highly contagious virus, within two days it passed on to my oldest daughter. I ended up staying at home to care for them both and lost five days pay. My daughter also lost a week's wage as she would have returned to work on the Thursday but they did not want her to return too early and spread it through the office. It seems unknown for certain the length of time the virus remains contagious.
Make sure you ask your pharmacist to give you the Tamiflu medicine that is covered by the government. There are a couple of ways to prepare it and not all compound versions are covered. Also, the capsules must be prescribed as two a day for five days because one a day for 10 days is considered preventative medicine and not free.
One more bit of advice... the children's suspension medicine has a taste worse than Buckley's so mix it with chocolate milk!

Swine flu goes viral

2009-12-30T22:35:00.000-08:00

Small beginnings
Thursday, 16 July 2009
Predictions of a pandemic had become so common – and so often came to nothing – that the reports in March 2009 of Mexicans falling ill from ‘swine flu’ first only merited a paragraph or two in the papers. But by today the World Health Organization has now declared a pandemic and the disease is truly global. What was at first treated with humour is now treated with nervousness as the first people in the UK die from the disease and, despite government assurances, parents pull their children out of school where there is even a rumour of swine flu.
Patient Zero
Monday, 3 August 2009
Who was the first person in the world to get swine flu? Experts are divided between a six-month-old child in Mexico and five-year-old Edgar Hernandez. But Edgar is the one who has caught the attention of the world media (well, babies are more difficult to interview) and Edgar even has a statue of himself.
The statue is called Nino Cero – Little Boy Zero – and it stands in Edgar’s home town of La Gloria, Mexico. It may be doing some good. It’s starting to attract tourists to the small town, no doubt giving a welcome boost to the economy. But others are unhappy at their town becoming infamous as the place where swine flu started.
Mass of Separation
Thursday, 6 August 2009
I am grateful to Channel Four blogger, Dr Peter Stott, for bringing this to my attention. It is the Mass of Separation from the 13th Century and was a series of instructions to sufferers from leprosy. Strangely, the instructions are equally valid today for avoiding the spread of swine flu. Just shows how little our understanding of viruses has grown in 700 years!
MASS OF SEPARATION
“I forbid you to ever enter a church, a monastery, a fair, a mill, a market or an assembly of people.
“I forbid you to leave your house unless dressed in your recognisable garb and also shod.
“I forbid you to wash your hands or to launder anything or to drink at any stream or fountain, unless using your own barrel or dipper.
“I forbid you to touch anything you buy or barter for, until it becomes your own.
“I forbid you to enter any tavern; and if you wish for wine, whether you buy it or it is given to you, have it funnelled into your keg.
“I forbid you to share house with any woman but your wife. I command you, if accosted by anyone while travelling on a road, to set yourself down-wind of them before you answer.
“I forbid you to enter any narrow passage, lest a passerby bump into you.
“I forbid you, wherever you go, to touch the rim or the rope of a well without donning your gloves.
“I forbid you to touch any child or give them anything. I forbid you to drink or eat from any vessel but your own.”
It comes back
Friday, 7 August 2009
Should we be happy/relieved/cautious over the latest swine flu figures that show only 30,000 new cases were reported last week (compared with 110,000 the previous week)? I keep hearing the catchphrase from BBC4’s docudrama, The Forgotten Fallen, in my head: “It comes back”. Which is of course what Sir Liam Donaldson and others keep saying.
Welsh whisky
Saturday, 8 August 2009
There appears to be a story doing the rounds in foreign newspapers and websites that Welsh whisky is a miracle cure for swine flu.
Now even the Welsh would admit that it takes a brave person to drink Welsh whisky and it may be responsible for many things but miracle cures ain’t one of them.
It seems this story got started when a Russian sports team was visiting Wales and they were advised to drink whisky as a way of avoiding getting swine flu. And from this small beginning the internet rumour began.
Where there’s muck...
Wednesday, 12 August 2009
Swine flu may be pretty frightening but it’s not going to stop some people making a quick buck.
How about swine flu T-shirts, the swine flu fridge magnet, or even the swine flu hat? All are available online.
Tamiflu humour
Friday, 21 August 2009
An old joke revamped for the swine flu era... Doctor: “Take this Tamiflu and your swine flu symptoms will be gone in a week. If you don’t take the Tamiflu your symptoms could take seven days to disappear.”
A cliché exposed
Saturday, 22 August 2009
My concerns over the trite phrase “underlying health problems” (UHPs) being trotted out every time someone dies from swine flu have been borne out. It has become almost a journalistic cliché – no-one simply dies of swine flu, they all have “underlying health problems”. My suspicion is that people in authority are using this as a way of reassuring the public that swine flu is not dangerous; people can relax – they weren’t ‘ordinary’ people who died from swine flu, they were deeply ill in the first place. Alarm bells rang in particular when a Northern Ireland soldier Lee Porter died from swine flu and it was said he had UHPs. The Belfast Newsletter interviewed his family who strenuously denied he had UHPs. It adds that Lee was: “Employed full time for the Northern Ireland Fire Service, he had been involved with the Territorial Army since the age of 18 and had also progressed to the rank of Company Sergeant in the Army Cadet Force.” So in fact he was incredibly fit – surely a more important news story that someone of his ilk can be brought down by swine flu than someone with UHPs?
Burying victims in the catacombs
Wednesday, 2 September 2009
Someone posted on the comments section that Exeter council had drawn up a plan to put “all the bodies” from a swine flu epidemic into the catacombs below the city. It sounded so ridiculous I could only assume it was one of the Friend of a Friend stories. But it turns out to be absolutely true.
It’s probably a bit over the top in the ‘worst case scenario’ stakes but where to store the bodies is a genuine issue if the pandemic is at the top end of the scale. And in cold caves is probably as pragmatic a place as any.
Lack of swine flu data is a scandal
Sunday, September 6 2009
It’s appalling that the details from official sources are so sparse that I am having to do this. It’s difficult to see what this secrecy achieves – except suspicion that the government is hiding the true situation. The public should be given as much information as possible.
It’s difficult to pick out the worst offender but I’m going to have a go anyway: Newham University Hospital Trust. The good work of reporter Susan Smith on the Newham Recorder enabled the paper to discover that someone on their patch had died of swine flu. The Trust grudingly confirmed the fact but the most telling line in Susan’s story is “Newham University Hospital NHS Trust will not reveal the gender of the patient.” For goodness sake, why not? This nonsense – the lack of data – has got to stop.
One-fifth of flu deaths ‘healthy’
Thursday, 17 September
Last night’s Panorama didn’t reveal many new facts but it did confirm what I had been told earlier by the Health Protection Agency – that the majority (four-fifths) of swine flu victims have those so-called Underlying Health Problems. That leaves one-fifth who are perfectly healthy. It’s a worrying figure which recalls the ghost of the Spanish flu of 1918 which seemed to “like a good fight” (in the words of the recent docudrama on TV).
Black Death v Swine Flu
Saturday, 19 September
“The ‘hushing-up’ system is in sanitary matters about as dangerous as anything can well be” – The Lancet, 1870.
I’ve moaned on many an occasion about the lack of any helpful details on swine flu deaths. The website Straight Statistics shares my exasperation and points out: “When a British soldier dies in Afghanistan, we know within days the sex, age and region of residence of the fatality, together with the immediate cause of death. How different it is for swine flu.”
Actually, there’s a more stark example than the parallel with soldiers dying in Afghanistan: I can find out more details about people who died during a visit the Black Death to Cumbria in 1598 than I can about swine flu in 2009. For the Black Death I can tell you how many died, their names, where they lived, the precise date of their death, sex, occupation, partner’s name, social class and whether they were buried in the churchyard or out on the Fells. No ages are given but it would be easy to work these out by checking with the baptismal records. In contrast the information given to the public about swine flu deaths in modern Britain in 2009 is: the number of deaths and... er, well that’s it really.
The more bizarre headlines
Monday, 5 October 2009
Swine flu is not a laughing matter but here are some of the more bizarre swine flu headlines that have caught my eye...
No Swine Flu deaths in Botswana
Canadian Aboriginals get body bags after asking government for swine flu help
Is St Thérèse of Lisieux spreading swine flu?
Prisoners Got Drunk On Swine Flu Gel
Now they want to ban handshakes
Media spreading virus of fear.
The nature of the beast
Friday, 23 October 2009
I think Dr Ruth Hussey has put her finger on the nature of the swine flu beast in her latest bulletin. The North West Director for Public Health said: “It seems that although the total number of people catching the virus is going up slowly overall, the complications people are experiencing are severe.”
In the early days of swine flu, we were expecting many people to be ill and many to be seriously affected or killed. But it seems rather than this strain of pandemic is affecting many – most not seriously at all – but others it is singling out for a particularly severe attack.
Why? What is it about those who are being worst affected? There seems no common denominator – you can be very healthy or have severe health problems; you can be young or you can be old; you can be male or female. But Dr Hussey’s observation perhaps gives a clue to how best the NHS can form a strategy to tackle swine flu in the next few weeks – a concentration on the large minority who are going to need very specialist treatment to get them through it.
The anti-vaccine militia
Sunday, 1 November 2009
The vaccine against swine flu has always had its opponents but since it’s not compulsory it’s never really had any raison d’etre.
However, a group calling itself The People’s United Community have gone into Birmingham hospitals putting up posters and handing out leaflets attacking the vaccine. “Swine flu is not the biggest danger. It’s the vaccine.” say the posters.
Not surprisingly their campaign has incurred the wrath of health officials who point out that a) They’re wrong and b) 89 of the 137 deaths from swine flu so far might have been avoided if the vaccine had been available earlier in the UK. How many more deaths might therefore be caused by inaccurate information persuading people not to take the vaccine? Healthy debate is one thing. Irresponsible scare-mongering is another.
Strange goings-on in Ukraine
Tuesday, 3 November 2009
Type ‘swine flu Ukraine’ into Google news and you’ll see unfolding some extraordinary events. Nearly 70 people have died from swine flu according to the authorities (in the UK the total is 135 so I’m not sure why that’s worried them so much) but they’re closing schools, universities, banning public meetings and you can’t buy a face mask for love nor money.
Some Western commentators are bemoaning that the Ukraine is asking the world for help but not giving any deatils about why these 70 people died or any background information (Good grief! They should try getting information about UK deaths – it makes the Ukraine look like a role model in openness!).
How bonkers is this?
Saturday, 7 November 2009
The latest swine flu death in Scotland is of an adult from the Ayrshire and Arran area. Authorities are not releasing the gender “for reasons of confidentiality”. Has this country gone completely bonkers?

Asthma Sufferers At High Risk For Future H1N1 Pandemics

2009-12-30T22:27:00.000-08:00

Health experts predicted another round of H1N1 flu virus cases could hit next year and that people who suffer from asthma are at especially high risk, Channel 4 Action News’ Sally Wiggin reported Wednesday.
This was demonstrated in a study last spring of H1N1 flu patients admitted to Massachusetts hospitals, Wiggin said. The study looked at people who also had other chronic medical conditions and almost a third of those people had asthma.
Local allergy and asthma expert, Dr. Deborah Gentile, told Wiggin flu strains are a danger asthma sufferers face every year.
“Unfortunately, patients with asthma are always at risk for side effects of complications when they get the flu, including H1N1,” Gentile said.
The H1N1 flu can trigger an asthma attack, breathing problems, pneumonia, and severe breathing difficulties that require a ventilator, Wiggin reported.
Gentile said she saw dozens of patients like this during the most recent H1N1 epidemic. Many of whom, luckily, did not have to be admitted for hospital stays.
“We actually give our patients treatment plans,” Gentile said. “So if they start to get sick they know how to monitor their illness, exactly what steps to take to control their exacerbation, and when to contact us.”
Patients were advised to watch for H1N1 symptoms similar to other flues, like cough, fever, muscle aches, respiratory problems, and, in the case of the H1N1 flu, even nausea, Gentile told Wiggin.
“We would consider treating them with Tamiflu and consider if they needed an increase in their asthma medications,” Gentile said.
It was reported that children with asthma are at even higher risk for complications due to H1N1 flu than adults, Wiggin said.
Gentile also recommended that all asthma sufferers get the H1N1 vaccine, regardless of age.
“Go get one right now. There is no shortage at this point,” Gentile said. “Check with your pediatrician, your general practitioner, call the county health departments where you live. Find out where [the vaccines] are available. [The H1N1 flu] will come back.”
Asthma sufferers were also advised to get seasonal flu shots, Wiggin reported. Studies indicated seasonal flu can be just as dangerous for asthma patients as the H1N1 flu strain.

JARGON OF THE YEAR: Long-term economic value

2009-12-30T22:23:00.000-08:00

It was the phrase that allowed the Government to pay more for the assets of zombie banks through the National Asset Management Agency (Nama) than they were worth – €54 billion instead of €47 billion, to be precise. It was such an apparently reasonable-sounding snippet of genius that the International Monetary Fund (IMF) felt the need to praise the Department of Finance for its “masterful” definition. IMF adviser Steven Seelig described “long-term economic value” as both “sufficiently specific” and “sufficiently vague” to allow “appropriate flexibility” for Nama: “I hope you can retain this language,” he mused in a private e-mail. Seelig has now joined the board of Nama, so we can only hope he didn’t spend Christmas trying to come up with more clever phrases that end up costing taxpayers money.
Runners-up: TOGIT (The Only Game in Town), used to describe Nama (aka consensus thinking); green shoots (of recovery fame); PIIGS (term used by London brokers to describe high-deficit states Portugal, Ireland, Italy, Greece and Spain).
APOLOGY OF THE YEAR: Tim Berners-Lee
2009 was the year of the apology. Stars of reality TV shows, British MPs, homophobic Daily Mail columnists and wayward golfers gave multiple apologies when the first attempts weren’t judged sufficiently sincere. But while bankers fell over themselves to deliver a PR-scripted mea culpa to the television cameras, the most momentous apology of the year lay well outside the world of imploding collateralised debt obligations. Yes, Tim Berners-Lee, creator of the worldwide web, apologised for adding those irritating forward slashes to the beginning of internet addresses, confessing that they were an “unnecessary” part of URLs and had just wasted everyone’s time. “There you go, it seemed like a good idea at the time,” he said. A bit like Hotmail.
Runner-up : A special mention goes to Pat Farrell, Irish Banking Federation (IBF) chief executive, for the sheer quantity of apologies that he gave throughout 2009.
U-TURN OF THE YEAR: Marks & Spencer
2009 featured so many Facebook “protests” that, by the end of the year, 160,000 people had joined something called An Arbitrary Number of People Demand That Some Sort of Action Be Taken – a Facebook protest against Facebook protests, if you will. Still, Planet Business thinks some lasting good was achieved when Facebook group Busts 4 Justice forced Marks & Spencer to do a U-turn on its policy of charging extra for bras with a cup size above DD. The clothing retailer originally defended its position by saying the charge – described by the Busts 4 Justice group as a “tit tax” – reflected the cost of producing larger bras. But it eventually backed down, taking out advertisements in the British press to say “we boobed” and introducing a one-price-fits-all policy on lingerie.
Runner-up : General Motors was revved up and ready to sell Opel and Vauxhall to Canadian supplier Magna before deciding it would keep its European business and axe 10,000 jobs instead.
VILLAIN OF THE YEAR: The public sector
The public-sector worker may seem like a harmless creature, living a humble life of parking spaces, increments and flexi-time, but do not be deceived.
In 2009, we learned that a monster of such devastating wickedness had never existed before . . . There it went, nonchalantly fighting crime, unashamedly saving lives, blatantly giving our kids homework.
Sooner or later, it would have to be stopped, this indestructible nemesis of such frightful power that it had the ability to suck money from the kitty jar marked “national Anglo debt servicing payments” and bleed innocent bankers dry of their bonuses.
Runners-up : The real nominees are former Merrill Lynch head John Thain, who spent $1.22 million (€848,000) furnishing his suite of offices with antiques mere days after Bank of America rescued Merrill; and Chelsea magnate Roman Abramovich, who – in an open audition for a role in the next Bond film – bought a yacht containing a missile defence system.
HERO OF THE YEAR: Gary Geogh, AIB shareholder
The Irish Times doesn’t want to condone egg-throwing. However, in a field with few contenders, Keogh is the Planet Business hero of the year for his services to shareholder activism. After hurtling a brace of eggs at the board of AIB – scoring a direct hit on the suit of AIB chairman Dermot Gleeson – the pensioner declared that he felt “happier about the whole thing than I have done for months”, referring to his €18,000 loss on an AIB investment. “Always aim for the body,” he said, explaining that victims often move their heads before the eggy missile reaches its target. Of Gleeson’s double career as both banker and lawyer, he noted, “you couldn’t get a worse combination”.
Runner-up : Richard Branson, for making the dream of commercial space travel that bit closer to reality.
PRODUCT OF THE YEAR: Tamiflu
There’s nothing like a pandemic to give a company a captive market, and for Roche AG, the pharma giant that owns the patent to an anti-viral drug called oseltamivir (brand name Tamiflu), the 2009 outbreak of H1N1 swine flu was like hitting the virus jackpot. Stockpiles of Roche’s Tamiflu (and GlaxoSmithKline’s Relenza drug) had to be released and replenished, leaving Roche on track to make €1.85 billion from Tamiflu by the end of 2009. It expects to sell 400 million Tamiflu units in 2010, which will be pleasant for us all.
Runners-up : Raw garlic, as consumed by Minister for Finance Brian Lenihan, according to David McWilliams; iPhones for their ubiquity (and the Paper Toss app).
ADVERTISEMENT OF THE YEAR : Galtee Irish Breakfast
Any pretence in keeping ads linked to some semblance of reality was abandoned this year. Cheryl Cole was recruited by L’Oréal to be the face of its Elvive shampoo, despite the fact that what had actually got her hair’s “mojo” back was her expensive set of hair extensions. Ageing rocker Iggy Pop starred in ads for Axa subsidiary Swiftcover, which was later forced to admit it doesn’t give car insurance to musicians. But the winner is Breeo Foods, which had a complaint upheld against it for promoting a Galtee Irish Breakfast mail order product that, despite promising “the sizzle of Irish sausages”, did not contain Irish sausage meat.
Runner-up : Amazingly straight-faced Carte Noire coffee ads with Dominic The Wire West.
INNOVATION OF THE YEAR: The "safe" bed
Google, Apple, Facebook, whatever . . . There was one innovation that truly caught the mood early in 2009: the “safe” bed. Wouldn’t trust a senior bank executive to look after your life savings? Not even Halifax Bank of Scotland star Colm Meaney? Bed manufacturer Feather Black had the product for anyone brave enough to embrace the interest-free, insurance-free world of under-the-mattress cash storage – a bed that conceals a safe.

Tamiflu not effective for serious flu

2009-12-29T13:35:00.000-08:00

Roche has claimed that its Tamiflu dramatically reduced hospital admissions as well as bronchitis and pneumonia. But a recent investigation by the British Medical Journal and UK’s TV Channel 4 has concluded that such claims are meritless
Public Citizen, a US-based non-profit consumer advocacy organisation, has called for an independent review of the raw data from clinical trials funded by Tamiflu’s maker, Roche Holding AG.
"Tamiflu is being erroneously peddled as a panacea to flu," said Dr Sidney Wolfe, director of Public Citizen's Health Research Group. "In fact, no research exists to support this (claim) in healthy adults. At best, it can modestly reduce some minor flu systems in such people for a day."
Public Citizen claimed that the drug does not prevent serious complications from the flu and advised that it should not be used for routine control of the flu in healthy adults.
Switzerland-based Roche, the world's largest maker of cancer drugs, had claimed that its Tamiflu dramatically reduced hospitalisations as well as bronchitis and pneumonia. However, a recent investigation by the British Medical Journal and British TV Channel 4 concluded that such claims are unfounded.
In the wake of widespread media coverage of the H1N1, or swine flu virus, Tamiflu sales have skyrocketed. In October, 2.5 million prescriptions were filled in the US compared with just 35,000 prescriptions in October 2008. For the past 12 months, 6.8 million prescriptions were written, compared with 4.3 million in the previous 12 months, said consumeraffairs.com in a report.
In India too, Tamiflu was moderately effective for the treatment of H1N1 influenza or swine flu. “The tablets were not as effective as the company claimed it to be, but were moderately effective. The drug had side effects like diarrhoea, skin reactions and vomiting,” said Dr Mahesh Shetty, a physician based in Navi Mumbai.
According to Indian government data, from September onwards, when it permitted the retail sale of the H1N1 drug, Roche’s Tamiflu has sold 4,47,340 tablets while all generic drugs that include Hetero’s Fluvir, Natco’s Natflu and Cipla’s Anti-flu have sold around 44,725 tablets combined in the 50-odd shops in the national capital region.
Tamiflu is effective only if it is taken within 48 hours of getting infected. Once the lungs are damaged, the chances of survival are less. According to health officials, India’s swine flu toll has reached 880 so far.
“Not all cases of H1N1 were serious. There was so much noise about nothing in the media. In India, many people die everyday from a disease like diarrhoea rather than swine flu,” added Dr Shetty.
Tamiflu is mainly advised for the prevention of H1N1 virus and not as a treatment. People who showed symptoms of even fever were prescribed Tamiflu (oseltamivir), which means that patients who were not suffering from H1N1 ended up taking the drug, which caused side-effects.
According to the World Health Organisation (WHO), over 11,500 people have died due to the H1N1 virus worldwide.

Tamiflu Doesn't Work on Flu Complications

2009-12-28T23:12:00.000-08:00

Tamiflu, the anti-flu drug being snapped up in record amounts, does not prevent serious complications from the flu and should not be used for routine control of the flu in healthy adults, according to Public Citizen.
The group is calling for an independent review of raw data from clinical trials funded by Tamiflu's maker, Roche. The company has claimed that the drug dramatically reduced hospital admissions as well as bronchitis and pneumonia. But a recent investigation by the British Medical Journal and British TV Channel 4 concluded that such claims were meritless.
In the wake of widespread media coverage of the H1N1, or swine flu, virus, Tamiflu sales have skyrocketed. In October, 2.5 million prescriptions were filled in the U.S. compared with just 35,000 prescriptions in October 2008. For the past 12 months, 6.8 million prescriptions were written, compared with 4.3 million the previous 12 months.
"Tamiflu is being erroneously peddled as a panacea to flu," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "In fact, no research exists to support this in healthy adults. At best, it can modestly reduce some minor flu systems in such people for a day."
FDA spokeswoman Patricia El-Hinnawy tells ConsumerAffairs.com that "controlled clinical trials conducted among outpatients with acute uncomplicated seasonal influenza reported a reduction of approximately 1 day in the duration of illness when antiviral treatment with oseltamivir (Tamiflu) was initiated within 48 hours of illness compared with placebo."
All of the clinical research conducted to determine the effectiveness of Tamiflu on healthy adults has been funded by the drug's manufacturer, Roche, Public Citizen said. The British investigation involved a review of all published studies examining the effects of Tamiflu in preventing serious complications of the flu in otherwise healthy adults.
The authors concluded that we "have no confidence in claims that [Tamiflu] reduces the risk of complications and hospital admission in people with influenza," and they wrote that it should not be used in routine control of seasonal influenza. There was also concern about underreporting of side effects of the drug.
El-Hinnawy responds that "a manufacturer conducts clinical trials according to FDA requirements, as part of the application for approval of a drug. The data from the trials are reviewed as part of the application 'package'." She adds that "if claims are being made by the company that are not substantiated by the data we reviewed, then the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) would become involved,” but, “nothing at this point in time would lead us to require an independent review of the data.”/p>
Although the data available were gathered before the H1N1 virus made its appearance, the results can probably be extrapolated to H1N1 because it is another variety of flu, Wolfe said.
El-Hinnawy notes that there are some observational studies in the published literature assessing potential benefits of Tamiflu in reducing complications, including deaths, among hospitalized patients with 2009 H1N1. But, she says, "There are limitations to these studies and therefore they are not generally included in product labeling."

Should I take Tamiflu?

2009-12-28T13:15:00.000-08:00

Q. If I get the flu, should I take Tamiflu? Will it keep me from getting really sick?
A. Tamiflu, generic name oseltamivir, is an antiviral drug used to treat seasonal flu in people who have had symptoms for fewer than two days, and in people who have been exposed to influenza virus but have not yet shown symptoms.
Dr. Anita Barry, director of the Infectious Disease Bureau at the Boston Public Health Commission, says that the question of whether Tamiflu is effective does not have an easy answer. “If healthy people begin to take the medication within 48 hours of symptom onset, it tends to relieve their symptoms about a day sooner’’ than if they hadn’t taken the drug, she says, assuming they are infected with a strain of influenza that is susceptible to the drug. H1N1 swine flu has responded to treatment with Tamiflu, although isolated reports of resistance have emerged this season.
Barry adds that Tamiflu is routinely given to hospitalized patients with the flu, as there is some evidence they can benefit even after the 48-hour window. She says the data are less clear as to whether the drug can reduce health complications of flu.
Some governments stockpile Tamiflu to prepare for flu outbreaks, but a recent review in British Medical Journal questions this policy. The Cochrane Collaboration, an international group that produces reviews of medical literature, analyzed published clinical trials of Tamiflu and other drugs of its class, called neuraminidase inhibitors, and found that there is not enough information to conclude whether they prevent serious complications of flu such as pneumonia.
Dr. Martin S. Hirsch, an immunologist at Massachusetts General Hospital, says that though the Cochrane review grabbed headlines, it does not really contradict current medical practice. “Current recommendations are to use oseltamivir for those with suspected or confirmed influenza who fall into certain high-risk groups,’’ including people suffering from other illnesses, children under age 2, adults 65 or older, and pregnant women.

Tamiflu distribution to start

2009-12-28T13:10:00.000-08:00

Persons prescribed Tamiflu can send a person who is over 18 to collect it, as the A(H1N1) strategy takes a new turn, in line with WHO and ECDC recommendations, and those displaying flu symptoms within certain categories, are to be administered Tamiflu without testing.
These include pregnant women, children under the age of five, people of all ages who seem to be developing complications and all people who are at greater risk of doing so, such as those who suffer from some chronic illness or those with a weak immune system.
All those persons who do not fall into these categories will be treated normally, and will not be given Tamiflu.
Tamiflu can be collected from the following places: Pharmacyon

Did a Flu Drug Manufacturer Withhold Evidence From Drug Trials?

2009-12-25T00:07:00.000-08:00

Doctors have alleged that Roche, the manufacturer of Tamiflu, has made it impossible for scientists to assess how well the anti-flu drug stockpiled around the globe works by withholding the evidence the company has gained from trials.
A major review of what data there is in the public domain has found no evidence Tamiflu can prevent healthy people with flu from suffering complications such as pneumonia.
Tamiflu may shorten the bout of illness by a day or so, the investigators say, but it is impossible to know whether it prevents severe disease, because the published data is insufficient. Roche has failed to make some of the studies carried out on the drug publicly available.

Dr. Mercola's Comments:
This is not the first time that conscientious scientists have questioned the work of researchers and drug manufacturers who, for a variety of reasons, fail to provide solid clinical evidence that a drug or medical device they are promoting really works.
History is full of examples where “science” was fudged – that’s the nice word for manipulated, if not outright falsified – to facilitate a desired outcome. It’s called bias, something that can happen either subconsciously or intentionally, when a scientist sets out to prove a point (hypothesis).
Bias was the topic of a report in 2007 that analyzed in depth how and why bias happens, and what can be done to curb it. The main concern is that bias can distort results of clinical trials, making a drug or medical device appear to be more effective than it is.
“Unless (bias) is carefully controlled, treatments that actually have little or no therapeutic potential often seem to produce fairly substantial benefits,” the author of this study wrote.
A year ago, in August, Donald Light, a professor and sociologist at the University of Medicine and Dentistry in New Jersey, voiced similar concerns at the annual meeting of the American Sociological Association. Asserting that drugmakers cherry pick clinical trial subjects to assure positive outcomes, Light quoted a Cochrane Center analysis that shows company sponsorship not only can create a conflict of interest when it comes to outcomes, but in itself is a major predictor of positive effects.
Why Did it Take So Long for Someone to Call Roche Out?
Tamiflu has been around for over ten years, and the claims about the drug's effectiveness in reducing hospitalizations have been a key factor in decisions by governments around the world to stockpile Tamiflu.
The drug, however, has a rocky reputation trailing it, including reports of Japanese children who suffered bizarre psychological side effects from it, in some instances leading to their deaths. Subsequently, Tokyo’s Ministry of Health instructed officials not to give Tamiflu to children ages 10 to 18, after receiving reports of 18 pediatric deaths connected with the drug.
When symptoms such as convulsions, delirium or delusions – but no reported deaths – happened to U.S. children, major media began reporting that the FDA was investigating the possible association between Tamiflu and neuropsychiatric effects.
Roche mentions the Japanese Tamiflu side effects on its website and in its package insert. But it also discounts the reports by saying, ”The contribution of TAMIFLU to these events has not been established.”
It’s no surprise that a drugmaker would try to contradict any findings that would negate or cast doubt on its products. But it’s outrageous that Roche and the FDA – as well as the World Health Organization – would continue to push Tamiflu, now that at least one major medical journal as well as a major magazine are questioning possible conflicts of interest between endorsers of Tamiflu, as well as its true effectiveness in combating flu symptoms.
In an article on December 10, 2009, The Atlantic repeats its earlier allegations that Tamiflu just isn’t what it’s been made out to be. The scientific evidence just isn’t there, The Atlantic tells its readers. Citing an investigation by the Cochrane Collaboration, The Atlantic reports that Cochrane researchers were repeatedly rebuffed by Roche scientists and officials when they tried to duplicate Tamiflu’s clinical data.
Ultimately, after multiple requests over several months, Cochrane determined that “ the evidence that Tamiflu reduces complications, hospitalizations, or deaths is weak at best, and if the drug does offer any benefit, it is slight indeed.”
When you consider that the U.S. FDA also told the British Medical Journal that its findings show that there is no difference between Tamiflu and a placebo, it makes me wonder why somebody hasn’t called Roche on the carpet about this sooner. Add in the fact that some whistleblowers admitted to ghost-writing some of Tamiflu’s published studies, and "outrageous" isn’t a sufficient adjective for what Roche has done.
The Ultimate in Recycling: Remake It for Kids
It’s an understatement to say that I am shocked at the façade that Roche has managed to keep up on Tamiflu all these years. But even more shocking is the latest news about this dangerous and questionable drug: The FDA has approved using expired Tamiflu capsules to make an oral liquid version of the drug for children!
The reason, according to media reports, is because liquid Tamiflu, ordinarily mixed in the factory just for children, has run short while Roche concentrated on making the adult version in pill form. To make up for the shortage – and possibly to help take care of Tamiflu pill leftovers from the bird flu hoax – the FDA implemented its shelf-life extension program.
The “new” children’s version will be concocted from old Tamiflu lots left over from the government’s own national stockpile.
How convenient! If you can’t get rid of it on a pandemic, just recycle it. Expiration dates be damned.
Public Health Emergency for Expired Antivirals
The government isn’t the only agency that will be using expired antivirals, however. On October 31,2009, on its News and Events website, the FDA outlined how companies, U.S. states and localities, and other organizations with Tamiflu and Relenza (GlaxoSmithKline’s version of Tamiflu) can recyle their flu antiviral leftovers. The recycling is possible for up to a year under an emergency declaration by the Secretary of the Department of Health and Human Services.
The site explains that during this public health emergency (which I would assume refers to the swine flu) the FDA has issued emergency use authorizations for these expired, or soon-to-be expired, drugs.
Eighteen lots of Tamiflu Capsules and three lots of Relenza Inhalation Powder have been authorized by FDA for use beyond their expiration dates under this directive, the site says.
But that’s not all. The emergency declaration not only allows the use of expired antivirals, but also waives the storage requirements for Tamiflu!
What are they thinking? Why would they do this? Why would expiration dates even be suggested on a drug, if they were not important? And storage? If the way you store a drug isn’t vitally important, why would they have storage requirements in the first place?
It is interesting how the drug companies conveniently manipulate expiration dates. Nearly ten years ago the Wall Street Journal (long before it was purchased by Murdoch) ran an excellent expose on drug expirations which is still valid today.
Seems when it is to their benefit they make the expirations nice and short so people will purchase them more frequently, but when they get stuck with the “expired” drugs they claim they are safe to use. How can they possibly have it both ways?
Why Doesn’t the FDA Follow Its Own Guidelines?
Unfortunately, it’s shenanigans like this that cast doubt on true science and researchers who work hard to show that their data is substantive. When the very agency that is supposed to protect you changes its rules to fit whatever game it’s playing at the moment, it’s hard to believe anything that the agency puts out.
And that can be alarming, because one day the FDA may come up with some important rulings, possibly during a real pandemic of epidemic proportions, that people won’t pay attention to, after fiascos like this.
The FDA has policies and procedures aimed at reducing conflicts of interest in drug trials and reviews. But it also provides a slew of waivers that can allow scientists – or ghostwriters – to get away with creating studies that contain significant bias.
Many arguments could be posed for why researchers would want the FDA to overlook bias in their work. The obvious one is greed. Less obvious is a subconscious “placebo-type” effect that simply leads the researchers into coming to conclusions they don’t really see.
This effect could be due to what’s known in the scientific world as “target-based discovery”. That’s when a researcher sets out with a target in mind – say, you want to find a drug component that can reduce flu symptoms – and then comes up with trials that point straight to the target.
It doesn’t necessarily have to be an intended consequence, meaning a dishonest attempt to deceive, but, like a placebo effect, what happens is that human nature tends to find what the brain is looking for.
The need for speed could be another factor in how bias comes into play. Sometimes public pressure for a cure can hurry up drug research and production – and increase the possibility of tainted trials.
But no matter what the reason, there’s no excuse for it.
There are Cost-Effective Ways to Control Bias
Perhaps Roche and the FDA should read that 2007 article on how bias can adversely affect clinical trials. In it, the author, Mark Lindner, shows how controlling bias actually can increase productivity and, ultimately produce more revenue than having to recall a failed drug.
Making sure that bias doesn’t happen from the start, in the preclinical trials, is one of the best ways to assure that an ineffective drug doesn’t expend time and money in the actual trials, Lindner says.
This is vitally important, because in clinical trials, the hopes, beliefs, and expectations (together referred to as the biases of the patients and investigators) can affect the results, usually to exaggerate the therapeutic effects of the treatment being evaluated, according to Lindner.
As far as Tamiflu goes, we don’t know what happened with the clinical trials of this drug. We can only guess if bias or conflicts of interest played a part in its creation. Was it pressure to quickly come up with a drug to combat flu? Or money? Or was it wanton placebo-effect expectations that brought this drug to market? We don’t know.
What we do know, however, is that there’s more evidence of Tamiflu being harmful, than evidence backing up its reputed effectiveness. In fact, proof of its benefits is nearly nonexistent.
The truth is, Tamiflu just isn’t as safe or effective as you’ve been led to believe. I’ve been telling my readers to avoid this dangerous drug for years, and finally the word is getting out.

Worldwide H1N1 Deaths Top 10,000

2009-12-24T23:56:00.000-08:00

With the worst pandemic in over two decades, the H1N1 virus has taken over and has been linked to over 10,000 deaths worldwide. The virus is not only spreading throughout the United States but rather in countries all over the world. In the U.S., the CDC estimates that 1 in every 6 Americans have been infected by the H1N1 virus.
The World Health Organization(WHO) announced on Friday, December 18, 2009 that no less than 10,582 deaths have occurred as a result of the swine flu. These deaths reportedly span over 208 countries that have lab-confirmed cases of the H1N1 virus.
Despite the staggering number of deaths, the crusade against the H1N1 virus actually seems to be working well. According to a recent statement released by the WHO, swine flu activity has substantially declined in the United States and Canada with levels nearing the seasonal baseline.
Prescriptions written for the anti-viral flu drug Tamiflu have also significantly decreased, as have swine flu diagnoses in the United States over the past month.
The rate of infections have notably decreased throughout the U.S. The rate of infections in Europe have decreased as well, however 99% of all flu cases in the countries throughout Europe are confirmed cases of the swine flu.
Other countries experiencing diminishing flu activity include Japan, Taiwan and Mongolia, South America and the Caribbean, as well as parts of China.
Unfortunately some countries were not so lucky. Countries experiencing an increase in the rate and severity of cases include the countries scattered throughout Western, Central, and Southeast Asia.
The 10,582 deaths so far only include the deaths from April of 2009 to December 13, 2009. Several more death may have occurred since that time, and many more deaths are likely to happen thereafter. The WHO identifies that the number of deaths in a typical flu season are between 250,000 and 500,000.
Until a cure is found the best way to combat this worldwide pandemic is by washing hands frequently, employing other techniques for prevention, and vaccination. Keep yourself well-educated on the ever rampant H1N1 virus and employ as many prevention techniques as possible to keep yourself and your family happy and healthy this holiday season.

New antiviral effective against bird flu

2009-12-24T00:38:00.000-08:00

A compound tested in mice has proved safer and more effective against H5N1 bird flu than the popular antiviral Tamiflu, scientists in Wisconsin said.
T-705 even works after several days of infection, said Yoshihiro Kawaoka, a virologist at the University of Wisconsin's School of Veterinary Medicine.
"H5N1 virus is so pathogenic even Tamiflu doesn't protect all the infected animals," Kawaoka said. "This (antiviral) compound works much better, even three days after infection."
T-705 has been tested successfully against bird flu and H1N1 swine flu in mouse experiments and is being tested on humans in Japan against seasonal flu, Kawaoka said in the Proceedings of the National Academy of Sciences.
Some scientists believe bird flu, which is extremely difficult to treat, could spread worldwide, though so far cases have been isolated to Asia.
T-705 targets the viral molecule polymerase, an enzyme that enables the virus to copy its genetic material. By disabling polymerase, the virus can't create new virus particles needed to maintain the chain of infection, Kawaoka said in a release Tuesday.

Tamiflu still prudent for pandemic influenza

2009-12-24T00:28:00.000-08:00

The Public Health Agency of Canada (PHAC) is standing by its decision to stockpile and widely distribute neuraminidase inhibitors such as oral oseltamivir (Tamiflu) for use against the pandemic (H1N1) 2009 influenza, despite an updated Cochrane review that questions their usefulness.
The review assessed 20 trials to see how well neuraminidase inhibitors prevented or reduced the symptoms of influenza, its transmission and complications in healthy adults (BMJ 2009;339:b5106). It also assessed the frequency of adverse events and concluded that while the drugs reduced the symptoms of influenza by about a day, they do not prevent infection or stop viral spread. The authors questioned the reliability of evidence that the drugs reduce the risk of complications in healthy adults and advised against prescribing them to treat seasonal influenza.
in an accompanying editorial, the British Medical Journal argued that as public health agencies had stockpiled oseltamivir on the basis of the manufacturer’s claims that oseltamivir reduced the risk of complication in healthy adults, it is imperative that Roche make available the data from eight unpublished trials.
But PHAC indicated that the controversy is immaterial to its recommendations. “The articles published in the BMJ do not change [the] Public Health Agency of Canada’s advice with respect to the use of antivirals with the H1N1 flu virus,” PHAC said in a written response to CMAJ inquiries. PHAC also noted that the World Health Organization has indicated it would not vary its advice about using antivirals.
The Cochrane review focused on seasonal influenza, not the pandemic (H1N1) 2009 virus, the agency pointed out. It said antivirals are not recommended for treating healthy adults with mild illness, but continued to recommend them for those at risk of complications, including young children, pregnant women, people with chronic medical conditions and patients who are “very ill.”
Leading Canadian infectious disease experts backed PHAC’s decision to stockpile the drug and make it widely available. They also concurred on the reviewers’ call for more studies.
Given that the drug is safe, cheap and has some impact on the severity and duration of symptoms, Dr. Allison McGeer believes it makes sense to use it.
“Faced with the same data and the same decision again, I think people should be stockpiling,” adds McGeer, director of infection control at the Mount Sinai Hospital in Toronto, Ontario.
It’s difficult to get good data about reductions in complications in an outpatient population, which is where most people are taking oseltamivir, says McGeer, who also questioned Jefferson’s interpretation of the data about complications.
In the review, principal investigator Dr. Tom Jefferson and colleagues noted a reduction in complications that is not statistically significant in a meta-analysis, but is clinically significant, says McGeer. The data implies that if a patient is treated within 48 hours of the onset of symptoms, they are 55% less likely to have complications than if they were not treated.
“When you’ve done studies that demonstrate a 55% reduction in complications, the message is not that they (the drugs) don’t work — the message is that we want more data,” she says.
The main problem for doctors treating influenza patients with the antivirals is that they are very effective if patients come for treatment in the first 6 to 12 hours, and generally effective up to 48 hours. But many people don’t come in for treatment that early, McGeer says.
Dr. Fred Aoki, an infectious disease physician at the Winnipeg Health Sciences Centre and an influenza researcher at the University of Manitoba, and McGeer, argued that the negative interpretation of the data was a function of under-powered studies, which took place during years where there was no severe influenza strain.
Aoki believes that once the data is analyzed from the most recent outbreak, it will show that treating with oseltamivir does reduce complications. “It’s my expectation that oseltamivir should work against this pandemic virus.”
The trick will be to get it into the hands of people more quickly than during the first 36-48 hours of their illness, he adds.
Stockpiling it was the right thing to do, Aoki says. “We have to take out this insurance policy against there being unpredictable catastrophic disease.” But he adds that emerging information about resistance to oseltamivir means that PHAC should consider replacing the stockpile of oseltamivir with zanamivir, an inhaled antiviral.

Swine flu kills 9 in 48 hours

2009-12-23T06:06:00.001-08:00

On Monday, seven people had succumbed to swine flu. On Tuesday, the H1N1 virus claimed two more lives as Kaushal Gupta, 69, died in Sterling Hospital in Ahmedabad while Ramlal Mavadia, 76, succumbed in GG Civil Hospital in Jamnagar. At least three more people died on Tuesday due to suspected swine flu but their test results are yet to be ascertained.
The high number of deaths has sent alarm bells ringing as Health officials urged private medical practitioners to follow renewed World Health Organisation (WHO) guidelines and administer Tamiflu to suspected swine flu patients in the initial days of symptoms to avoid complications.
In Gujarat, it has been noticed that most patients who died in public hospitals were being treated for viral infections and pneumonia and brought for swine flu treatment when severe complications had set in. “It is important that private doctors take up the challenge of simple management of flu patients. Many patients are first treated for simple fever even pneumonia delaying H1N1 treatment which can prove fatal for patients. If doctors suspect that patient may have swine flu, they should start Tamiflu, said health secretary Rajesh Kishore who said swine flu was expected to worsen in winter. While a surge in swine flu was expected in winter season, public congregations like Unjha fair, the IIM festival and the forthcoming Kankaria Carnival are feared to expose more people to the virus.
While the government had installed thermal scanners at Navratri and Ambaji festivity venues, it curiously will not be scanning lakhs of people who will throng Kankaria. “Six medical team with eight doctors will be put to monitor swine flu. The check-ups will be voluntary and not mandatory for visitors,” said AMC medical health officer Suhas Kulkarni.
Meanwhile, infectious diseases specialist Dr Atul Patel said most doctors in other districts are not even aware that Tamiflu is now available in their region on prescription. “More awareness needs to be created. Also government might think of importing vaccines which will help stem the onslaught of swine flu,” said Dr Patel.

Tamiflu oral suspension supply update

2009-12-22T23:39:00.000-08:00

Roche has notified healthcare professionals that they have begun shipping additional quantities of Tamiflu (oseltamivir phosphate) oral suspension. Production of Tamiflu oral suspension was prioritized and increased in response to a supply shortage in September 2009. Roche continues to make all forms of Tamiflu, and increasing quantities of the oral suspension will become available through the beginning of 2010.
In the event that the oral suspension is unavailable, pharmacists may compound a suspension from Tamiflu 75mg capsules (final concentration 15mg/mL) using either of two vehicles: Cherry Syrup (from Humco) or Ora-Sweet SF (sugar-free) (from Paddock), following the FDA-approved instructions found in the Tamiflu Prescribing Information. In response to the shortage, Humco and Paddock Labs have increased production of Cherry Syrup and Ora-Sweet SF, respectively.
Tamiflu is available as a 12mg/mL oral suspension and as capsules in 30mg, 45mg, and 75mg dosage strengths.
For more information call (800) 526-6367 or visit Pharmacyon

New Japanese flu drug protects mice from avian flu

2009-12-22T23:28:00.000-08:00

An experimental influenza drug can protect mice against H5N1 avian influenza better than the preferred drug Tamiflu, researchers reported on Monday.
The drug, called T-705 or favipiravir, is made by Fujifilm Holdings Corp (4901.T) unit Toyama Chemical Co. It works differently from Tamiflu and Relenza and seems to work at lower doses, the researchers reported in the Proceedings of the National Academy of Sciences.
Tamiflu, Roche AG (ROG.VX) and Gilead Sciences Inc's (GILD.O) popular pill and Relenza, GlaxoSmithKline's (GSK.L) (GSK.N) and Biota Inc's (BTA.AX) inhaled flu drug, must be given with 48 hours to be fully effective.
"This compound works much better, even three days after infection," Yoshihiro Kawaoka of the University of Tokyo and the University of Wisconsin said in a statement.
"Our results suggest that T-705 is safe and effective in combating H5N1 influenza viruses and is, thus, a promising candidate antiviral for the treatment of highly pathogenic H5N1 patients," Kawaoka and colleagues wrote.
Although it has not, like H1N1 swine flu, caused a pandemic, H5N1 avian influenza is still circulating. It has infected 447 people and killed 263 of them since 2003, and most experimental new flu drugs, such as T-705, were being tested against H5N1.
Flu experts still fear H5N1 could quickly change into a form that humans could easily pass from one to another and it is far more deadly than H1N1.

"H5N1 virus is so pathogenic even Tamiflu doesn't protect all the infected animals," Kawaoka said.
The virus also could combine with with resistant strains of seasonal influenza virus to become both resistant to drugs and also more easily transmitted.
"Therefore, there is a need for unique and effective antivirals to combat H5N1 influenza viruses," he said.
SWINE FLU TOO
Experts also fear that H1N1 swine flu could become widely resistant to Tamiflu, as its seasonal strain has.
The government-funded study, available here, used mice infected with a highly pathogenic version of H5N1.
The drug also stopped the overreaction of the immune system that many researchers believe sometimes kills flu patients.
Kawaoka is sometimes paid to speak for drug companies, but this study was funded by the Japanese and U.S. governments.
Other experimental flu drugs in the pipeline include peramivir, made by Biocryst Pharmaceuticals Inc (BCRX.O) and licensed to Shionogi & Co Ltd (4507.T). It is licensed for emergency use in the United States for extremely ill patients who must be treated intravenously.

Fox Valley briefs

2009-12-22T00:00:00.000-08:00

McHenry County makes flu treatment available
The McHenry County Department of Health is making the flu medicines Tamiflu and Relenza available to primary care physicians and pharmacies as treatment of H1N1 symptoms in high-risk people. The department received two shipments of the antivirals as part of the Centers for Disease and Prevention Control's Strategic National Stockpile. The medicines are free to those who are not able to afford them otherwise. The CDC remains cautious of a third wave of H1N1 in the spring, coupled with seasonal flu. Those exhibiting H1N1 symptoms should check with their health care provider for antiviral availability. For more flu tips, visit mcdh.info or call the department's H1N1 hotline at (815) 334-2800.
Flu vaccine at the library
The Dundee Township Library will offer vaccines for H1N1, seasonal flu and pneumonia from noon to 4 p.m. Monday, Dec. 28. The shots will be administered on a first-come, first-served basis. The H1N1 shots are $15, while the seasonal flu shot is $25 and the pneumonia vaccine is $45. Cash or check payments are accepted. Medicare is not. The H1N1 vaccine is an injectable shot containing a dead virus. The nasal spray will not be available. Children through 10 years of age should get two doses of the vaccine about a month apart. If your child has already received one dose a minimum of 30 days ago (injection or nasal spray), he or she they can receive a second dose at the library. Children 11 or older and adults need only one dose. For details, call the library at (847) 428-3661 or visit online at dundeelibrary.info. The Dundee Township Library is at 555 Barrington Ave., East Dundee.
Carpentersville needs volunteers
The Village of Carpentersville is looking for candidates to serve on the village's newly adopted Business Development Commission. The seven-member commission will be appointed on the basis of experience and background. Not all members will be required to be village residents. However, at least four members must be electors and residents of the village for at least one year. One resident will be a consumer and registered to vote. The commission will function in an advisory capacity and will meet at least monthly.

Compound Found to Safely Counter Deadly Bird Flu

2009-12-21T23:51:00.000-08:00

The specter of a drug-resistant form of the deadly H5N1 avian influenza is a nightmare to keep public health officials awake at night. Now, however, a study published the week of Dec. 21 in the Proceedings of the National Academy of Sciences (PNAS) suggests that a new compound, one on the threshold of final testing in humans, may be more potent and safer for treating "bird flu" than the antiviral drug best known by the trade name Tamiflu.
Known as T-705, the compound even works several days after infection, according to Yoshihiro Kawaoka, a University of Wisconsin-Madison virologist and the senior author of the new PNAS study.
"H5N1 virus is so pathogenic even Tamiflu doesn't protect all the infected animals," explains Kawaoka, a professor of pathobiological sciences at the UW-Madison School of Veterinary Medicine and a world authority on influenza. "This compound works much better, even three days after infection."
The Wisconsin research was conducted in mice and demonstrated that the compound was effective and safe against H5N1 virus, the highly pathogenic bird flu virus, which some scientists fear could spark a global epidemic of deadly influenza. The compound is also effective against seasonal flu and more worrisome varieties such as the H1N1 virus, and has already been tested against circulating seasonal influenza in humans in Japan where it is on the brink of Phase III clinical trials in people.
The prospect of a new front-line drug for influenza, in particular highly pathogenic strains such as H5N1 virus, is important as there are few drugs capable of checking the shifty influenza virus. The new study showing the efficacy and safety of T-705 assumes more importance as instances of Tamiflu-resistant strains of H5N1 virus have recently been reported, raising concerns about the ability of current antiviral drugs to blunt a pandemic of deadly avian flu.
Antiviral drugs are viewed as a readily available first line of defense against pandemic flu and are especially important for protecting health workers and others during an outbreak of disease. Vaccines, which utilize inactivated or weakened viruses to confer immunity, are the primary line of defense for influenza, but require months to formulate and mass-produce.
Aside from its safety and basic efficacy, another key trait of the T-705 compound is the fact that it is effective even after an infection is acquired. Bird flu, notes Kawaoka, is almost always diagnosed in the hospital after symptoms of the disease manifest themselves: "This compound has a chance to save people who have gone into the disease course," he says.
T-705 targets a critical viral molecule, polymerase, an enzyme that enables the virus to copy its genetic material, RNA. By disabling polymerase, the virus is unable to make new virus particles and maintain the chain of infection. Tamiflu, which remains an effective drug for blocking influenza virus, targets and regulates the enzyme neuraminidase, a protein found on the surface of the flu virus particle and that is essential for spreading the virus throughout the respiratory system.
"The activity of this agent is considerably higher than Tamiflu," says Kawaoka, adding, "the compound is very specific to viral polymerase. It doesn't affect host polymerase, which is important for safety and reducing side effects."
The new Wisconsin study was funded through the Program of Founding Research Centers for Emerging and Reemerging Infectious Diseases; the Japan Science and Technology Agency; the Ministry of Education, Culture, Sports, Science and Technology of Japan; and by the U.S. National Institutes of Health.

Swine flu patients urged not to collect medicines themselves

2009-12-21T06:05:00.000-08:00

The health authorities are urging people sick with swine flu to stay at home rather than going themselves to pick up the antivirals from government pharmacies or health centres.
Instead, they should send a relative to pick up their medication so as not to infect other people with the influenza that is causing a global pandemic.
From today, private family doctors will be able to prescribe the antiviral Tamiflu to vulnerable people with flu-like symptoms and those who start showing complications. The antivirals can be picked up from government pharmacies or health centres when the pharmacies are closed and also from the pharmacy at the Gozo Hospital.
This arrangement has raised concerns that people with influenza could transmit the virus to other patients queuing to pick up their medicines or even to the pharmacists dispensing the medicines.
Answering questions by The Times, a spokesman for the Community Care Parliamentary Secretariat said people who were sick should "strictly" stay at home and let their relatives pick up antivirals for them.
"Any other person queuing for other medicines can be a carrier. Asymptomatic patients are running around in the community without them being aware.
"Hence, the risks from relatives picking up medicines is not bigger than that of any other person running around in the community," the spokesman said.
The authorities said they did not intend to install Perspex barriers to protect pharmacists and there would not be a separate waiting area for people who need to pick up antivirals.
Tamiflu will be given to pregnant women, children under five years of age and those with chronic diseases of the heart, lungs, liver and kidneys or diabetes.
Healthy people who are showing signs of complications will also be given the drugs.
Tamiflu may be collected from the Birkirkara, Paola, Mosta, Cospicua, Floriana, Qormi, Luqa and Gżira government phar-macies, Mount Carmel and Karen Grech hospitals, the Rabat, Cospicua, Qormi, Paola, Mosta, Floriana and Gżira health centres and from the General Hospital in Gozo.

Seoul to ship Tamiflu aid to Kaesong

2009-12-21T00:29:00.000-08:00

South Korea will send a stockpile of Tamiflu and other anti-viral drugs to North Korea later this week to help control an outbreak of the A(H1N1) virus there, the Unification Ministry said yesterday.
North Korea has accepted South Korea’s offer to provide anti-viral drugs for 500,000 people after acknowledging nine domestic cases of type-A influenza last week.
“On Friday, our government will deliver the aid to Kaesong via the road” that crosses the western side of the inter-Korean border, ministry spokesman Chun Hae-sung said at a briefing. Kaesong is a North Korean town just north of the border that houses an inter-Korean industrial complex and is connected to Pyongyang by an expressway.
The aid comprises Tamiflu doses for 400,000 people and Relenza, another anti-viral drug, for 100,000, the ministry said.
The medication and its delivery in refrigerated trucks will cost about 18 billion won ($15 million).
Doctors will accompany the trucks to oversee the delivery and give advice to North Koreans on how to use the medication.

Roche CEO sees group outpacing market in '09-paper

2009-12-21T00:21:00.000-08:00

Swiss drugmaker Roche Holding AG (ROG.VX) will have grown considerably faster than the market this year, the group's head was quoted as saying in an interview with Swiss newspaper SonntagsZeitung.
"2009 will be a very good year. Even without Tamiflu, we will significantly outpace the market. Thanks to the quality of our pipeline we will also be able to build up our market position in the long term," CEO Severin Schwan said.
Roche has 10 new investigational agents in late stage development, Schwan said.
Roche, the world's biggest maker of cancer drugs, posted a forecast-beating 10 percent rise in third-quarter sales in October, helped by demand for antiviral drug Tamiflu due to the H1N1 swine flu pandemic.[ID:nLD628052]
Tamiflu sales are likely to be above 2.7 billion Swiss francs ($2.59 billion) this year and Schwan said the group would likely see significant sales next year, but it was difficult to be more precise as it was not yet clear how swine flu and seasonal flu would develop.

Tamiflu, Relenza offered to docs

2009-12-17T06:02:00.000-08:00

The McHenry County Department of Health has made available its recent shipment of Tamiflu and Relenza to interested primary care physicians and pharmacies.
Antivirals are intended for treating H1N1 symptoms in high risk individuals as prescribed by a physician. As part of the Centers for Disease Control and Prevention’s Strategic National Stockpile, two shipments of antivirals have been received in McHenry County since April for use by health departments, local hospitals and health care providers. Antivirals from the national stockpile are free to individuals who are unable to afford them.
“To reduce the impact that influenza has on families, it is important that treatment be readily available,” said Patrick J. McNulty, McHenry County Public Health administrator. “Antivirals, when used in appropriate situations, have proven to reduce the severity of H1N1 symptoms, and to return individuals to their regular routines.”
Officials at the Centers for Disease Control remain wary of a possible third wave of H1N1 in the spring, coupled with seasonal flu, McHenry County health officials said in a news release.
Influenza is a contagious and unpredictable illness and can lead to serious infection, especially to anyone with underlying medical conditions. It is important to reduce risk of contracting the flu and spreading it to others. Health officials encourage residents to become vaccinated and follow the three Cs: cover your cough, clean your hands, and contain your germs by staying home if you’re sick.
Individuals exhibiting H1N1 symptoms should check with their health care provider for antiviral availability.

Tamiflu May Have Been Falsely Marketed

2009-12-16T11:06:00.000-08:00

Two months ago, we pointed out in our story on flu in The Atlantic that the antiviral drug Tamiflu might not be as effective or safe as many patients, doctors, and governments think. The drug has been widely prescribed since the first cases of H1N1 flu surfaced last spring, and the U.S. government has spent more than $1.5 billion stockpiling it since 2005 as part of the nation’s pandemic preparedness plan.
Now it looks as if our concerns were correct, and the nation may have put more than a billion dollars into the medical equivalent of a mirage. This week, the British medical journal BMJ published a multi-part investigation that confirms that the scientific evidence just isn’t there to show that Tamiflu prevents serious complications, hospitalization, or death in people that have the flu. The BMJ goes further to suggest that Roche, the Swiss company that manufactures and markets Tamiflu, may have misled governments and physicians. In its defense, Roche stated that the company “has never concealed (or had the intention to conceal) any pertinent data.”

Call me crazy: Pregnant and panicked about swine flu

2009-12-15T06:27:00.000-08:00

I've just gotten on the elevator, and I have a problem. The buttons are staring at me, all dark, waiting to be pushed. I look at the 5, knowing that's where I need to go, but I hesitate. Who knows how many germy fingers have touched it this morning?
After staring at the panel for a few seconds, I poke the 5 with my elbow, happy nobody else is around to see my awkward, swine-flu-avoiding move.
I have not always been a neurotic germaphobe.
Even after I learned I was pregnant with my second child, I would share bottles of water with friends, gladly open doors and shake strangers' hands without a care. I thought it was healthy for my toddler to get a few colds to help boost her immune system. But since the swine flu outbreak, I've gone a bit off the rails.
I now push doors open with my hip, scurry into restaurants on other patrons' heels so they have to hold the door for me, and always -- always -- have hand sanitizer within reach.
My germ fixation began when I started reading reports about children and pregnant women being disproportionately at risk of dying or becoming horribly ill from the H1N1 virus. About 10,000 Americans have died from it, including 1,140 children, since April. A lot of those people were healthy before they got it -- and that's the key difference between the swine flu and the flu from seasons past.
We've been told that pregnant women are 10 times as likely as other flu victims to be hospitalized if we get H1N1. Doctors now recommend the antiviral drug Tamiflu for us at the first signs of flu, even though it has not been tested on fetuses.
I was terrified.
I feared that pregnancy hormones might have put me in mommy overdrive, so I consulted my obstetrician, asking her how important it was for me to get the swine flu and seasonal flu shots. She told me a patient of hers years back died from the seasonal flu, and her husband's grandparents died in Spain from the 1918 flu, a strain similar to the one now circulating. That was all I needed to hear.All this is to explain why if someone coughs within earshot of me, I shoot them a dirty look. I keep my daughter away from kiddie museums and other places I deem possible flu incubators. I sacrifice trees, wasting paper towels in public bathrooms to cover faucets as I turn them on and off. I feel ridiculous doing these strange dances. But I am terrified my daughter or I will get sick and end up in the hospital, or worse. I used to make fun of my germaphobe friends. Now I e-mail them every day so we can talk swine flu developments and the latest newspaper article about the most recent death toll. I don't blame the media for my Code Orange panic. I think the reporting has been responsible and informative. A good friend of mine wrote a column in this newspaper telling everyone to chill. The message was lost on me. That same friend threw a Halloween party where 5-year-olds bobbed for apples as their parents held their hair out of the water -- something she jokingly called "swine stew." I was aghast -- though I have to say, I don't think any of those kids got sick. Still, I'm not taking chances. I'd rather live in this anxiety-ridden world I've created for myself for a few more months than risk getting that dreaded flu. So if you see me doing strange rituals, please understand it's only temporary. Oh, and could you hold that door?

Significant drop in demand for Tamiflu

2009-12-14T10:18:00.000-08:00

PARK House Antiviral Collection Point (ACP) in Burton Road, Carlton, has closed.
This is because there has been a significant reduction in the number of people requiring Tamiflu for the treatment of swine flu.
The decision will be reviewed in the New Year.
Ashfield Health Village ACP remains open from 1pm until 6pm, Monday to Friday, and midday to 3pm on Saturday and Sunday.
On bank holidays over the Christmas period, it will be open 10am to midday.
The ACP at the Co-operative Pharmacy at Balderton Care Centre remains open 10am to 4pm, Monday to Friday.
The ACP at Co-operative Pharmacy, Stapleford Care Centre, also remains open 10am to 4pm, Monday to Friday.
The situation will be monitored and NHS Notts County will maintain a flexible approach should demand increase or continue to decline.
Dr Chris Kenny, director of Public Health for NHS Notts County said: "After reviewing the number of flu friends passing through the ACPs this week, and in view of the general slowdown in demand, we have decided to stand down the ACP."

Tamiflu Given For Swine Flu Linked to Stevens Johnson Syndrome

2009-12-14T04:34:00.000-08:00

With all of the publicity and concern surrounding the swine flu, many people have taken solace in the fact that a treatment of limited benefit exists. This medicine is called Tamiflu, and although it can often speed up recovery for those suffering from H1N1, a recent report from England reveals that it can also cause Stevens Johnson syndrome, a potentially fatal reaction that affects one’s skin.
Samantha Millard, 18 years old and from Bicester in Oxfordshire, took the medicine after consulting a staff that had received no medical training. She quickly developed rashes all over her body, and is currently undergoing treatment at Chelsea and Westminster hospital. Possible results of the Stevens Johnson syndrome or SJS are blindness, loss of skin, and an inability to eat due to blisters in one’s mouth. SJS has also been commonly linked to Dilantin and it generic equivalent phenytoin.
Although the causes of Stevens Johnson syndrome vary by medication and the manner in which it is taken, medical officials in England and representatives from the Department of Health are looking into the incident and Tamiflu connection. They currently maintain that Tamiflu is still a favorable strategy for fighting the swine flu and encourage sufferers to take it as soon as possible.
Most importantly, stay in close contact with your doctor if you develop flu-like symptoms, and keep him or her updated on any side effects that any prescribed medicine has caused. At the first sign of a rash or other intended effect, please ontact your doctor immediately to ensure the best course for you and your recovery.

Tamiflu anti-viral drug revealed as complete hoax; Roche studies based on scientific fraud

2009-12-14T00:45:00.000-08:00

When it comes to selling chemicals that claim to treat H1N1 swine flu, the pharmaceutical industry's options are limited to two: Vaccines and anti-virals. The most popular anti-viral, by far, is Tamiflu, a drug that's actually derived from a Traditional Chinese Medicine herb called star anise.
But Tamiflu is no herb. It's a potentially fatal concentration of isolated chemical components that have essentially been bio-pirated from Chinese medicine. And when you isolate and concentrate specific chemicals in these herbs, you lose the value (and safety) of full-spectrum herbal medicine.
That didn't stop Tamiflu's maker, Roche, from trying to find a multi-billion-dollar market for its drug. In order to tap into that market, however, Roche needed to drum up some evidence that Tamiflu was both safe and effective.
Roche engages in science fraud
Roche claims there are ten studies providing Tamiflu is both safe and effective. According to the company, Tamiflu has all sorts of benefits, including a 61% reduction in hospital admissions by people who catch the flu and then get put on Tamiflu.
The problem with these claims is that they aren't true. They were simply invented by Roche.
A groundbreaking article recently published in the British Medical Journal accuses Roche of misleading governments and physicians over the benefits of Tamiflu. Out of the ten studies cited by Roche, it turns out, only two were ever published in science journals. And where is the original data from those two studies? Lost.
The data has disappeared. Files were discarded. The researcher of one study says he never even saw the data. Roche took care of all that, he explains.
So the Cochrane Collaboration, tasked with reviewing the data behind Tamiflu, decided to investigate. After repeated requests to Roche for the original study data, they remained stonewalled. The only complete data set they received was from an unpublished study of 1,447 adults which showed that Tamiflu was no better than placebo. Data from the studies that claimed Tamiflu was effective was apparently lost forever.
As The Atlantic reports, that's when former employees of Adis International (essentially a Big Pharma P.R. company) shocked the medical world by announcing they had been hired to ghost-write the studies for Roche.
It gets even better: These researchers were told what to write by Roche!
As one of these ghostwriters told the British Medical Journal:
"The Tamiflu accounts had a list of key messages that you had to get in. It was run by the [Roche] marketing department and you were answerable to them. In the introduction ...I had to say what a big problem influenza is. I'd also have to come to the conclusion that Tamiflu was the answer."
In other words, the Roche marketing department ran the science and told researchers what conclusions to draw from the clinical trials. Researchers hired to conduct the science were controlled by the marketing puppeteers. No matter what they found in the science, they had already been directed to reach to conclusion that "Tamiflu was the answer."
Now, I don't know about you, but where I come from, we call this "science fraud." And as numerous NaturalNews investigations have revealed, this appears to be the status quo in the pharmaceutical industry.
Virtually none of the "science" conducted by drug companies can be trusted at all because it really isn't science in the first place. It's just propaganda being dressed up to look like science.
Sadly, even the CDC has been fooled by this clinical trial con. As stated by author Shannon Brownlee in The Atlantic:
"...the Centers for Disease Control and Prevention appears to be operating in some alternative universe, where valid science no longer matters to public policy. The agency's flu recommendations are in lockstep with Roche's claims that the drug can be life-saving -- despite the FDA's findings and despite the lack of studies to prove such a claim. What's more, neither the CDC nor the FDA has demanded the types of scientific studies that could definitively determine whether or not the company's claims are true: that Tamiflu reduces the risk of serious complications and saves lives. Nancy Cox, who heads the CDC's flu program, told us earlier this year she opposes a placebo-controlled study (in which one half of patients would be given Tamiflu and the other half would be given placebo), because the drug's benefits are already proven."
Did you catch that last line? The CDC isn't interested in testing Tamiflu because "the drug's benefits are already proven." Except they aren't. But this is how the pharmaceutical industry operates:
Step 1) Fabricate evidence that your drug works.
Step 2) Use that fraudulent evidence to get your drug approved.
Step 3) Use fear to create consumer demand for your drug (and encourage governments to stockpile it).
Step 4) Avoid any actual scientific testing by claiming the drug has already been proven to work (and cite your original fraudulent studies to back you up).
This is the recipe the CDC is following right now with Tamiflu. It's a recipe of scientific stupidity and circular logic, of course, but that seems to be strangely common in the medical community these days.
Even the FDA says Tamiflu doesn't work
The FDA, remarkably, hasn't entirely given in to the Tamiflu hoax. They required Roche to print the following disclaimer on Tamiflu lables -- a disclaimer that openly admits the drug has never been proven to work:
"Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza."
Even further, an FDA spokesperson told the British Medical Journal, "The clinical trials... failed to demonstrate any significant difference in rates of hospitalization, complications, or mortality in patients receiving either Tamiflu or placebo."
It's the same message over and over again, like a broken record: Tamiflu doesn't work. And the "science" that says Tamiflu does work was all apparently fabricated from the start.
The Tamiflu stockpiling scandal
Junk science, though, is good enough for the U.S. government. Based on little more than fabricated evidence and Big Pharma propaganda, the U.S. government has spent $1.5 billion stockpiling Tamiflu. This turned out to be a great deal for Roche, but a poor investment for U.S. citizens who ended up spending huge dollars for a medicine that doesn't work.
As is stated in the Atlantic:
"Governments, public health agencies, and international bodies such as the World Health Organization, have all based their decisions to recommend and stockpile Tamiflu on studies that had seemed independent, but had in fact been funded by the company and were authored almost entirely by Roche employees or paid academic consultants."
Even if Tamiflu did work, there are Tamiflu-resistant strains of H1N1 are now circulating .
The upshot of all this is that governments around the world are flushing billions of dollars down the drain stockpiling a drug that doesn't work -- a drug promoted via propaganda and scientific fraud.
This isn't the first time your government has wasted taxpayer dollars, of course (it seems to be what the U.S. government does best), but this example is especially concerning given that this was all done with the excuse that natural remedies are useless and only vaccines and Tamiflu can protect you from a viral pandemic.
But as it turns out, vaccines and Tamiflu are useless and only natural remedies really work. That's why so many informed people around the world have been stocking up on vitamin D, garlic, anti-viral tinctures and superfoods to protect themselves from a potential pandemic that most world governments remain clueless to prevent.
I find it fascinating that the governments of the world are stockpiling medicines that DON'T work, while the natural health people of the world are stockpiling natural remedies that DO work. If a real pandemic ever strikes our world, there's no question who the survivors will be (hint: it won't be the clueless chaps standing in line waiting for their Tamiflu pills...).
Which remedies really do work to boost immune function and protect the body from infectious disease? I've actually published a special report revealing my top five recommended remedies:
In addition to the remedies mentioned in that report, I also recommend high-dose vitamin D as well as the Viral Defense product from www.PlantCures.com
I have no financial ties to any of the companies whose products are recommended here, by the way. Unlike the pharmaceutical industry, I don't operate purely for profit. My job is to get valuable information out to the People -- information that can help save lives and reduce suffering. This is the job the FDA and CDC should be doing but have long since abandoned in their betrayal of the American people.

H1N1 vaccine coming available to all; TamiFlu at pharmacies

2009-12-13T03:19:00.000-08:00

In addition to the H1N1 vaccine being open to all individuals starting Monday, Dec. 14, the Ohio Department of Health also is opening distribution of anti-viral drugs to help people who come down with the flu recover.
The department announced Wednesday, Dec. 9, a public-private partnership with four retail pharmacies to ensure the availability of antiviral medications.
Giant Eagle, Kroger, Meijer and Walgreens pharmacies will be the recipients of medications from the state's supply. The drugs will be administered to the pharmacies as needed if shortages arise. The chain stores then will send the medications to stores with low supplies.
"We're really grateful that these four retailers have stepped us to help us make sure that Ohioans who need antivirals for H1N1 and influenza have antivirals available for them," said Kristopher Weiss, spokesman for the department of health.
Almost 1.5 million courses of prescription antivirals are available through the state and others are available from federal outlets if necessary. Weiss said the majority of the doses are TamiFlu, with a few Relenza also in stock.
"Your doctor would prescribe them to you if you were very sick," Weiss said. "If you're a high-risk individual with a chronic illness ... you should call your doctor right away and talk about if antiviral medication might be good for you."
The antivirals reduce the length of the illness and the severity, Weiss said.
The retailers will pay for the drugs to be shipped to them; however, the pharmacies cannot charge the patient more than $3.75 for the drug, Weiss said.
"These are government assets that aren't being sold," he said.
Weiss said the department has yet to ship any supplies out and isn't sure if shortages will come about.
"There have been some spotty shortages reported around the country," Weiss said. "This was a step we wanted to take proactively in the event we experience a similar thing here in Ohio."
The Ohio Department of Health also was the authority that named Dec. 14 as the date for vaccines to be open to all people statewide.
With clinics open to all people, "That means every vaccine provider in Central Ohio that has a vaccine should make it available to all of our residents," said Jose Rodriguez, communications director for Columbus Public Health.
Columbus Public Health will continue to offer walk-in H1N1 vaccine clinics, but many other providers, such as doctors and pharmacies, will have vaccines as well.
"We encourage folks to get it wherever it is most comfortable for them," Rodriguez said. He recommended people check with their private health care providers before turning to other clinics.
"This is a great time to get vaccinated -- right before the holidays, right before people" start gathering together, he said. "This is not the time to let our guard down."
Rodriguez recommended college students who will return home for the holidays get their vaccine while at home.
"If you didn't get it done at school, this is a great time to get it done," he said.
"Parents of children under the age of 9 that got (their child) a first shot need to go back," Rodriguez said. "A child is not fully immunized until he or she gets the second dose."
Rodriguez said it does not matter where a parent takes a child for the second dose. The child does not have to return to the same vaccine provider that gave the first shot.

Fixing Fatal Tamiflu Resistance in Pandemic H1N1

2009-12-12T00:45:00.000-08:00

The recent report of H274Y cases doubling in the Netherlands in the past week, including 4 of 11 fatalities, has raised concerns that Tamiflu resistance has not only jumped to an evolutionarily fit pandemic H1N1 , but a lethal sub-clade. Similar numbers were reported in the United States where 10 new cases of resistance were described and four were fatal.
The report this week out of Vietnam left little doubt that H274Y was being efficiently transmitted to previously healthy young adults when seven students were infected during a train ride. Six were among ten students in one car, while a seventh was in another car, suggesting at least two independent transmission events. However, these patients recovered, even though the treatment with Tamiflu had little value since they were Tamiflu resistant prior to treatment. Sequences from these patients have not been released, so the relationship of this cluster to reports of sporadic cases is unclear.
However, sequences from the first Tamiflu resistant case without exposure to Tamiflu have been released and the HA sequence had a receptor binding domain change, D225E. Linkage between H274Y resistance and receptor binding domain changes was of concern because the fixing of H274Y in seasonal flu was linked to receptor binding domain changes. The key change in the fixing of H274Y was A193T, which emerged near the end of the 2007/2008 season and become dominant in the summer of 2008 in the southern hemisphere. This gave rise to an increase in H274Y to almost 100% of seasonal H1N1, with additional changes involving various combinations of polymorphisms at positions 187, 189, and 196,
The linkage between receptor binding domain changes and fixing of anti-viral resistance was also seen in S31N in seasonal H3N2. That change was linked to a change at position 193 (S193F),, as well as a change at position 225 (D225N).
Thus, when the H274Y in pandemic H1N1 was found in an isolate that had D225E, there was concern that the receptor binding domain could facilitate the spread of H274Y via a fit H1N1. These concerns were increased by a recent sequence from Tennessee which had H274Y and D225E.
However, two additional changes at position 225 were reported in pandemic H1N1 (D225G and D225N) and these changes were associated with fatal lung cases in Sao Paulo. The concerns were increased when sequences from Ukraine were released, which identified D225G in four of four fatal cases. Recently released sequences have added to the concern when the two new sequences, which were likely from fatal cases, had D225N. Both of these changes were found in a fatal case from Utah.
Concern that H274Y was pairing up with D225N was increased in a report fromFrance which cited two fatal cases with D225N and one of the two had H274Y. An expansion of this pairing could have dire consequences, because of the recent linkage between severe ad fatal cases with D225N, since Tamiflu remains as a first line defense against more severe cases of H1N1.
These concerns could be more appropriately addressed with the release sequences from the recent cases, including those that were fatal.
The fixing of H274Y In seasonal fu was linked to the jumping of H274Y and key polymorphisms from one genetic background to another via recombination. In pandemic H1N1, both H274Y and D225G have been found on multiple genetic backgrounds raising concerns that H274Y will soon be fixed in pandemic H1N1 and this fixing may be linked to receptor binding domain changes associated with severe and lethal infections.

H1N1 drug Tamiflu effectiveness questioned

2009-12-12T00:43:00.000-08:00

The medical journal BMJ (British Medical Journal) has claimed that anti-viral drugs, such as Tamiflu, may be ineffective against influenza viruses, including the H1N1 swine flu virus, when taken by otherwise healthy people.
The prestigious journal has, in a series of articles, said that the Swiss pharmaceuticals giant Roche, which sells the drug as Tamiflu, has concealed the detailed data required to justify claims of its effectiveness, reports New Scientist.
“Although billions have been spent on oseltamivir in the face of pandemic influenza,” the journal states, investigators “found that the public evidence base for this global public health drug was fragmented and inconsistent”.
The British Medical Journal report follows a World Health Organization (WHO) report a couple of weeks ago which indicated that the H1N1 swine flu virus may now be resistant to Tamiflu. (ANI)

Tamiflu Supply to North

2009-12-11T08:10:00.000-08:00

It is good to see that humanitarian aid to North Korea will be resumed after nearly two years of suspension. South Korea has decided to provide 500,000 doses of Tamiflu and other anti-viral drugs to the North to help fight the spread of swine flu. The decision came Thursday as Pyongyang accepted Seoul's offer of the medicines.
The provision of the drugs will mark the first humanitarian aid from the Seoul government to the North since President Lee Myung-bak took office in February 2008. Pyongyang has yet to accept 10,000 tons of corn aid offered by the South in October, apparently because of its dissatisfaction with the relatively small amount of assistance and the strings attached to it.
The North's decision on the medicine aid reflects its need for urgent action against the epidemic, also known as influenza A (H1N1). The decision was made immediately after the South conveyed its intention to help to the North at the instruction of President Lee. During a Cabinet meeting Tuesday, he told his ministers to provide ``unconditional" aid to help North Korea contain the highly contagious virus.
On Wednesday, the North made its first report of nine cases of the influenza outbreak in its capital Pyongyang and northwestern Sinuiju bordering China. However, there was no report of deaths from the flu attacks. However, a Seoul-based civic group quoted unconfirmed reports that the influenza virus has killed about 50 people in the North since early last month.
Unification Ministry officials are contacting North Koreans to decide details about how and when to transport the drug supply to the North. We hope the South will swiftly deliver the anti-viral drugs to the North so that they will become available to patients there. The sooner, the better as early action is pivotal in blocking a further spread of the epidemic. If necessary, the South should send medical equipment and medical staff to the impoverished North to better cope with swine flu.
We also expect that the medicine provision will serve as a catalyst to increase the South's humanitarian aid to the isolated country. The North is suffering from a food shortage. Thus, the Seoul government needs to persuade Pyongyang to accept its food assistance in order to feed millions of North Koreans fighting hunger. It goes without saying that humanitarian assistance should be offered without any preconditions. But, such aid may contribute to easing tensions on the Korean Peninsula and mending ties between the two rivals.

Doubt cast on Tamiflu effectiveness

2009-12-10T06:36:00.000-08:00

Researchers are questioning the effectiveness of the influenza treatment Tamiflu.
A study published in the British Medical Journal has found that the data relied on by the flu drug's manufacturer Roche cannot be verified.
The researchers say there is insufficient evidence to back Tamiflu's effectiveness and that more studies are now underway.
But the Australian Government is standing by its decision to spend hundreds of millions of dollars stockpiling the drug.
The Cochrane Collaboration is a global network of researchers that considers itself a scientific watchdog, regularly reviewing drugs.
It has just updated its previous review of Tamiflu. In the process, scientists followed up concerns held by a Japanese doctor about a lack of evidence about the drug's benefits.
Professor Chris Del Mar is the coordinating editor of the Cochrane Collaboration's acute respiratory infections review group. He is also the Dean of Medicine at Bond University.
He says doubt has been cast on studies relied on by the drug manufacturer Roche.
"The most important finding we found, which is a change from the previous review, was that we didn't have enough data to know whether it reduces the complications of influenza," he said.
"There was a study written by professor Laurent Kaiser from Geneva in Switzerland, which was a summary of about 10 different trials that had been conducted by Roche Pharmaceuticals.
"When we actually put the data together and analysed them, we found that we couldn't draw the conclusions that [professor] Kaiser had drawn. And so we felt very insecure about that. In fact we didn't think it was proper to use those data.
"When we wrote to [professor] Kaiser and said 'can you give us these data because we need to sort it all out properly', he wrote back and said, 'I'm very sorry I don't have the data'.
"That's a very weird thing to say. And he referred us to Roche. He said, 'You'll have to go and talk to the pharmaceutical company that funded it'."
Data deficient
Professor Del Mar says that Roche never gave out the data, only giving some tables of data that were not what was needed.
"I can only speculate. It would be pure guesswork. But I do know that this is a drug which has made a lot of money based on the conclusions drawn from this and maybe they're not keen for other scientists to scrutinise it in the way that the Cochrane Collaboration does," he said.
Professor Del Mar is reluctant to accuse Roche of making money under false pretences.
"I do think that we need the data before we can draw conclusions and that's why we've had to withdraw that conclusion that we had previously made," he said.
He says it is embarrassing that previous findings and recommendations had holes in them.
"It's something that makes me feel that we were rather naive as an organisation," he said.
People will be now wondering about the efficacy of the swine flu vaccine.
Professor Del Mar says there is reason to doubt other studies that drug companies cite to support the use of their drugs.
"I think this does call into question a lot of things about scientific debate and I am worried about it," he said.
The researchers concluded there is insufficient evidence to back Tamiflu's effectiveness in seasonal flu and they are unsure whether the same applies in pandemics like swine flu.
The Australian Government stockpiled millions of dollars worth of the drug during the swine flu pandemic and chief medical officer Jim Bishop stands by the move.
"What we found early on with the swine flu epidemic was that the particular virus that was causing it was quite sensitive to antivirals, both Tamiflu and Relenza," he said.
He says they have evidence to contradict the study's claims that Roche does not know whether or not their findings can be generalised from seasonal flu to a pandemic.
The World Today requested an interview with a Roche representative but the company instead released a statement accusing the scientists of carrying out an incomplete review.
The company also says it stands behind the robustness and integrity of its data.

Research Finds New Tamiflu Benefits

2009-12-10T01:09:00.000-08:00

As news of the H1N1 swine flu pandemic first broke, everyone scrambled for the drug Tamiflu. Governments released stockpiles, but still pharmacies frequently ran out of it.
Doctors prize Tamiflu because it is one of the few weapons that fights flu after a person has started showing symptoms.
But new research has suggested that the benefits of Tamiflu may have been overstated.
A British review found little evidence that the drug reduces serious complications of the flu, such as pneumonia, in otherwise healthy people. And overall, Tamiflu appears to cut the length of illness by less than one day.
However, a study on H1N1 patients in China suggested that Tamiflu may help stop the virus from spreading.
Patients treated with Tamiflu were more likely to have eliminated the virus from their systems within 5 days, meaning they would no longer pass it on.
So doctors still recommend the drug to high-risk groups -- such as those with chronic health problems like asthma or heart disease -- and to those who have close contact with them.

Do you have to wait between Tamiflu and vaccination?

2009-12-09T10:10:00.000-08:00

Q. My son got fever seven days before and took Tamiflu medicine. Can he get H1N1 vaccine now? Or does he have to wait for some time to take H1N1?
A. Tamiflu helps reduce the symptoms of the flu. It does not act as a vaccine or cure.
However, health professionals in general recommend anyone feeling sick wait and recover before getting a vaccine. Some forms of the vaccine, the nasal spray in particular, could heighten flu-like symptoms at the time of immunization.
So make sure your son feels 100 percent before heading to the clinic.

Study Finds Limited Benefit From Tamiflu

2009-12-09T10:07:00.000-08:00

British researchers said there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the drug reduces swine flu hospitalizations and deaths.
Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.
The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.
Fiona Godlee, BMJ's editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. "Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge," she said in a statement.
But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.
"This will not change our (Tamiflu) guidelines," said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.
And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they "firmly believe in the robustness of the data."
Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people -- precisely the policy Britain has adopted to fight swine flu.
In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor's recommendation.
In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.

Does Tamiflu work?

2009-12-09T05:36:00.000-08:00

A new analysis is questioning the value of the widely used antiviral drug Tamiflu for treating the flu.
Chris Del Mar of Bond University in Australia led a team of researchers that updated the widely respected Cochrane Collaboration's 2005 evaluation of the effectiveness of Tamiflu and other so-called neuraminidase inhibitors by compiling data from 20 studies that have examined the drugs.
The analysis, published online by the British medical journal BMJ, concludes that the available evidence indicates that the drugs have a "modest effectiveness" against the symptoms of the flu in otherwise healthy adults -- cutting symptoms by about a day. But the group concluded a "paucity of good data has undermined previous findings" suggesting Tamiflu could prevent severe complications from the flu. In an accompanying paper, Nick Fremantle and Melanie Calvert from the University of Birmingham reviewed additional studies and concluded the drug may reduce the risk of pneumonia in otherwise healthy people who get the flu, but the benefit is probably very small and needs to be weighed against potential side effects.
In an article accompanying the analysis, a researcher involved in the analysis criticizes Roche, the company that makes Tamiflu, for failing to provide details about studies that have been conducted to evaluate the drug. Peter Doshi of the Massachusetts Institute of Techology argues that the case illustrates the problems involved when pharmacecutical companies conduct medical research. Fiona Godlee, the journal's editor, notes that governments have spent billions of dollars to stockpile the drug to fight flu pandemics like the H1N1 pandemic and are unable to judge its effectiveness.
In responses to the analysis and to questions from the journal, James Smith from Roche defended the drug's effectiveness, saying studies had clearly demonstrated the safety and usefulness of the drug and argued that government regulatory agencies have full access to all the company's data.

Tamiflu effectiveness questioned

2009-12-09T01:44:00.000-08:00

Researchers in Italy, Australia and the United States want to pin down whether tamiflu is effective against pandemic influenza in otherwise healthy adults.
Tom Jefferson of the Cochrane Collaboration in Rome, Mark Jones of the University of Queensland in Brisbane, doctoral student Peter Doshi of the Massachusetts Institute of Technology and Chris Del Mar, coordinating editor of Cochrane Acute Respiratory Infections at Bond University updated a 2005 review of oseltamivir in pandemic influenza.
The public evidence base for this global public health drug -- oseltamivir -- is fragmented and inconsistent, Doshi said.
"Neuraminidase inhibitors -- a class of antiviral drugs targeting influenza A and influenza B -- have modest effectiveness against the symptoms of influenza in otherwise healthy adults. The drugs are effective post-exposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective," the study said.
"Neuraminidase inhibitors might be regarded as optional for reducing the symptoms of seasonal influenza. Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza. Independent randomized trials to resolve these uncertainties are needed."

Roche’s Tamiflu Not Proven to Cut Flu Complications

2009-12-09T01:24:00.000-08:00

Roche Holding AG’s antiviral drug Tamiflu may not prevent complications from influenza in healthy adults, according to a review by an independent research group that reversed its previous findings that the medicine warded off pneumonia and other deadly conditions linked to the disease.
The pill has been the mainstay of treatment for pandemic swine flu, which has killed nearly 9,000 people since it emerged in April, according to the World Health Organization. Roche, based in Basel, Switzerland, defended the benefits of the drug, which it expects to generate 2.7 billion francs ($2.64 billion) in sales this year.
An analysis of 20 studies by the Cochrane Collaboration showed Tamiflu offered mild benefits for healthy adults and found no clear evidence it prevented lower respiratory tract infections or complications of influenza, according to the group. The review, published in the British Medical Journal and broadcast yesterday on the U.K.’s Channel 4 News, showed the drug eased and shortened symptoms if taken quickly.
The report, an update of a 2005 analysis by Cochrane, excluded eight studies funded by Roche that haven’t been published and whose full data wasn’t given to the researchers. The exclusion reversed the nonprofit group’s earlier finding that Tamiflu protects against complications.
Insufficient Evidence
“We now conclude there is insufficient evidence to describe the effects of Tamiflu on complications of influenza or the drug’s toxicity,” Tom Jefferson, the lead researcher from the Cochrane Collaboration in Rome, said in a telephone interview. “We have multibillion-dollar public health policies in place that rely on evidence not available for independent analysis.”
The group, which reviews medical evidence, excluded the eight studies, involving 2,500 patients, because it couldn’t get satisfactory access to the data involving the healthy adults in the study, he said.
The report raises questions about how drugs are reviewed, approved and distributed, Fiona Godlee, the British journal’s editor in chief, wrote in an editorial. The studies originally used to establish the benefits of Tamiflu were written by Roche employees and paid consultants, under-reported serious side effects and failed to clearly identify all the authors, she wrote. In at least one case, a study was attributed to a researcher who disavowed any involvement to the journal, Godlee wrote.
‘Taken on Trust’
Governments relied on the studies to justify the widespread use of Tamiflu, known chemically as oseltamivir, she said. The reviewers were unable to find any independent studies of the drug in healthy adults, she said.
“This case exposes how much of the evidence on drug safety and effectiveness is taken on trust,” Godlee wrote. “Governments around the world have spent billions of pounds on a drug that the scientific community has found itself unable to judge.” She called for more independent research, greater access to raw data used to license and sell drugs and stricter regulations on the conduct, review and publication of medical research.
Roche defended the drug’s benefits and its research, saying confidentiality agreements with patients enrolled in the trials kept the company from giving the investigators unreserved access to the findings.
“We fully stand behind the robustness of the data and the integrity of that data, particularly the efficacy and safety of Tamiflu, the conduct of our studies and publication policies,” David Reddy, head of the company’s global pandemic task force, said on a conference call with reporters. “We believe this drug is playing a pivotal role in the management of the current pandemic.”
Data From Pandemic
Two published trials show Tamiflu reduces complications in patients with seasonal influenza, while an observational study suggests it may lower death rates, Reddy said. Data emerging from the swine flu pandemic shows giving the drug within two days of symptoms appearing is the only effective way to help patients, he said.
More than 8,768 people worldwide have died from swine flu since it was first identified in Mexico and the U.S. in April, according to the Geneva-based WHO. More than 68 million people have taken Tamiflu since it was approved a decade ago. Influenza kills as many as 500,000 people worldwide each year.
The WHO recommends giving Tamiflu to infected people with a high risk of developing complications, including pregnant women and people with underlying medical conditions. The researchers said there is little evidence now available to show that otherwise healthy people should be routinely given Tamiflu.
In the U.K., patients can get a Tamiflu prescription by calling a national hotline or filling out an online questionnaire about their symptoms.
“The evidence shows that if taken within 24 hours, Tamiflu reduces symptoms of influenza by about a day,” Jefferson said. “It may reduce transmission. But we could not verify the claims that Tamiflu reduces complications. Once you took out the eight unpublished studies, the data relating to healthy adults that weren’t published, what remained showed no effect.”

Roche dismisses Tamiflu criticism

2009-12-09T01:19:00.000-08:00

The Roche pharmaceutical company has dismissed the findings of a team of medical researchers against Tamiflu, branding their review of the swine flu drug incomplete.
The team, led by a Gold Coast academic, has queried the use of Tamiflu and criticised the secrecy of Roche which is making billions of dollars a year from the weapon of choice against influenza.
Roche has estimated sales of STG1.6 billion ($A2.88 billion) this year alone from Tamiflu.
The joint investigation by the British Medical Journal (BMJ) and the BBC's Channel Four found there is no clear evidence that Tamiflu prevents complications like pneumonia in healthy people.
The research team was led by Professor Chris Del Mar, Dean of the Faculty of Health Sciences and Medicine, and Pro-Vice Chancellor of Research at Bond University on the Gold Coast.
Roche said the research team chose to exclude vital information from their analysis and did not allow the company to independently verify the findings.
"This omission has led to an incomplete review of the efficacy of Tamiflu for the scientific community," Roche said in a statement.
"Roche welcomes dialogue on Tamiflu and any of our medicines conducted through the appropriate scientific channels."
However, Professor Del Mar said Roche refused to release its data unless the team signed unacceptable secrecy agreements.
"It makes us wonder what's there," he said.
"It was a secrecy clause which had to be itself secret - we wouldn't even be able to say we'd signed it."
The pharmaceutical giant said it stood by its data supporting the efficacy and safety of Tamiflu, the conduct of its clinical trials and its publication policies.
"The safety and efficacy of Tamiflu is well established in clinical trials, scientific peer-reviewed publications and post-marketing studies, and the drug has been approved by 80 regulatory authorities worldwide including the EMEA and the US FDA," the company said.
"Tamiflu has been commercially available for 10 years and used by around 68 million people worldwide."
Roche plans to soon provide reports on detailed clinical trials to a number of research bodies through a secure website to ensure patient confidentiality.
Claims about the effectiveness of Tamiflu against complications have been a key factor in decisions by governments around the world to stockpile the drug as part of plans to combat a possible swine flu pandemic.
Professor Del Mar said his study had global implications.
"We are less certain now about the usefulness of this drug, and we realise we don't actually know as much about it as we thought we did," he said.
Professor Del Mar said it was time for the Australian government to re-evaluate its response to the swine flu pandemic, and its use of Tamiflu for seasonal influenza.

Japan's swine flu deaths reach 100 after elderly Kyoto man dies

2009-12-07T11:08:00.001-08:00

Deaths in Japan related to the swine flu epidemic reached 100 after the Kyoto Municipal Government said Sunday that a man with an underlying illness who was vaccinated three weeks ago died after being infected by the H1N1 virus.
The 74-year-old man, who was running a fever of more than 38 degrees, tested positive Friday for type A influenza and was given the antiviral drug Tamiflu.
He collapsed at home around 10:30 a.m. Saturday and died 6 1/2 hours later in a hospital, city officials said.
His swine flu infection was confirmed Sunday by virus gene analysis, they said.
According to the municipal government, the man had two chronic diseases — malignant lymphoma and diabetes. He was vaccinated for swine flu Nov. 16.
On Saturday, a man in his 20s in the city of Akita died after his bronchial asthma worsened due to the flu virus. He was also being treated for a chronic neurological disease, according to Akita officials.
Also Saturday, a 51-year-old man in Kasugai, Aichi Prefecture, died after suffering from severe pneumonia, officials said. The man did not have any chronic diseases and was prescribed Tamiflu on Dec. 1 when he visited a local hospital.
The nation's first swine flu infection was confirmed in May, when an Osaka Prefecture high school student who returned from abroad tested positive at Narita International Airport.
The National Institute of Infectious Diseases said late last month that an estimated 10.75 million people have visited doctors due to influenza since early July. Many are believed to have been infected with swine flu.

Flu Test Wrong, Girl Almost Dies

2009-12-05T23:48:00.000-08:00

Hayli Murphy hears her mother's cell phone ring, and she bounces off the couch to get it. Watching her run around, it's hard to believe that just a few weeks ago, the 9-year-old was heavily sedated in a pediatric intensive care unit, a ventilator doing the job her lungs -- ravaged by H1N1 flu -- could no longer do.
Hayli Murphy hears her mother's cell phone ring, and she bounces off the couch to get it. Watching her run around, it's hard to believe that just a few weeks ago, the 9-year-old was heavily sedated in a pediatric intensive care unit, a ventilator doing the job her lungs -- ravaged by H1N1 flu -- could no longer do.
"She was right there. She was at death's door," remembered her mother, Julie Murphy.
Hayli spent 43 days in the intensive care unit at Children's Hospital of Southwest Florida.
Looking back at her daughter's illness, one of the things that strikes her mother is that in the days before Hayli was admitted to the hospital, a test showed that she did not have the flu -- twice.
Dr. Andrew Pavia, chairman of the pandemic influenza task force for the Infectious Diseases Society of America, and others are concerned that doctors are being misled by rapid flu tests and failing to treat patients who, like Hayli, really do turn out to have the flu.
"We've been seeing these rapid flu tests cause problems," Pavia said. "These tests are certainly quick and relatively inexpensive, but the problem is, they're not terribly accurate."
"They said she's fine"
Hayli Murphy was given her first rapid flu test in the emergency room September 21 after spiking a fever. The result was negative, and doctors sent her home.
"They said, 'she's fine. She doesn't have the flu. She's got a virus. Give her Motrin and Tylenol, and she'll be fine,' " Murphy remembered.
The next day, when Hayli's fever hit 104 degrees and she felt sicker, Murphy brought her back to the ER, where she says a rapid flu test again showed that Hayli didn't have the flu. Doctors diagnosed pneumonia and gave Hayli antibiotics.
Then, the next day, Hayli became so weak that her mother had to carry her into the emergency room.
"I picked her up off the couch and told my older daughter, 'Open the car door. I'm going to the hospital,' " she recalled.
This time, Hayli was admitted and put on the antiviral medication Tamiflu, which is most effective when given within 48 hours of developing flu symptoms.
"If they had given her Tamiflu earlier, that might have helped her not get into the state she was in," Murphy said.
The Tamiflu given so late in Hayli's illness wasn't enough to stop the H1N1 virus. Hayli spent the next 43 days in the intensive care unit, where day to day, no one knew whether she would live or die.
Watch more on Hayli's ordeal
"The doctors said, 'We're at a point where we can't help her anymore. We're doing everything we can,' " Murphy remembered.
"She was really on the edge of losing her life," said Dr. Roberto Monge, one of the doctors who treated Hayli in the hospital. "The virus mainly affected her lungs, but it affected other organs as well."
A sophisticated DNA-based test done in the hospital showed that Hayli did in fact have H1N1 flu. Although it's highly accurate, it can take days to get a result, and it's more expensive than the rapid test commonly given in doctors' offices and emergency rooms.
Pavia says studies of rapid flu tests show that a negative result is wrong about half the time.
"I've seen occasions where a rapid test is negative, and so both the patient and the doctor figure this can't be the flu. The patient gets sicker, and over the next 24 to 48 hours, the person ends up in the hospital or, in rare cases, dies," said Pavia, also chief of the department of pediatric infectious diseases at the University of Utah.
Keep up with the latest H1N1 news
One company that makes rapid flu tests says doctors should use them with care.
"Doctors should be aware that a negative result does not fully exclude the possibility that the patient has influenza," said Colleen White, a spokeswoman for BD. "Following a negative rapid test, physicians have the option to proceed to more advanced tests."
"When in doubt, treat"
Dr. Rhonda Medows, commissioner of the Georgia Department of Community Health, says she tells doctors in her state not to use the rapid tests. "I don't see the value," she said.
Instead, she advises physicians to follow their own judgment. "Do what we've always done as physicians: listen to your patient, and listen to their history," she said.
The Centers for Disease Control and Prevention recommends that doctors prescribe antiviral medications even when a rapid flu test is negative if the patient is severely ill, is deteriorating rapidly or belongs to certain high-risk groups.
"In the middle of a flu epidemic, if you have someone who's sick with asthma or heart disease or something else, or if someone's getting much worse, treat them for the flu even if the rapid test is negative," Pavia said. "When in doubt, treat."
He says he's concerned that not everyone is listening. "Doctors haven't gotten the message yet, and they really need to get the message," he said.
Track the H1N1 flu in your state
In Hayli's case, the doctor who treated her said the ER staff members did not rely solely on the tests. Monge says a clinical exam of Hayli on both emergency room visits indicated that she did not have the flu.
"She would have been dead within the next 24 hours"
Julie Murphy says she knows that if she'd listened to the rapid flu test, Hayli "would have been dead within the next 24 hours," because she wouldn't have sought care for her daughter.
Most children, fortunately, don't suffer with H1N1 the way Hayli Murphy did. The CDC estimates that out of the 8 million people below the age of 18 who contracted swine flu between April and the middle of October, 36,000 were hospitalized, and 540 died.
If your child has H1N1 flu and you're concerned that he or she may take a turn for the worse, here are five signs to watch out for.
1. Fast or troubled breathing
"Your child's chest should be moving very smoothly," said Dr. Arthur Lavin, associate clinical professor of pediatrics at Case Western Reserve University School of Medicine in Cleveland, Ohio. "He shouldn't have to tug to get air in and out."
2. Numb or blue fingers or toes
Andrea Samples knew that it was time to hightail it to the emergency room when her 15-year-old daughter, Jessica, said her fingers felt numb.
Watch how maternal instinct saved Jessica's life
Jessica ended up spending two weeks in the intensive care unit at Cook Children's Hospital in Fort Worth, Texas. Her heart was not working properly and couldn't pump oxygenated blood to her extremities, according to Dr. Linda Thompson, who helped take care of Jessica.
Jessica had been to another emergency room and to an urgent care center in the two days before being admitted to Cook Children's, and she was sent home.
Samples says it was frightening how quickly Jessica went from being mildly ill to being on death's door.
"At first I thought she had a sinus infection, but she deteriorated quickly. Everything happened within hours," she said of her daughter's illness in September.
3. Can't touch chin to chest
If your child can't touch her chin to her chest, it could be a sign that she has a complication of the flu called meningitis, Lavin says.
4. Symptoms improve and then return
If your child gets better but then the fever returns and the cough comes back even more severely than before, you should get medical care for your child right away, according to the CDC. This could be a sign of a secondary infection.
5. A fever with a rash
Another emergency sign in children who have H1N1 is a fever with a rash, according to the CDC.
The CDC has more emergency warning signs parents need to watch out for.
Perhaps the most telling sign that your child needs medical attention immediately is if something just doesn't seem right: if your child seems much worse than before or is just not herself.
"If your child somehow seems like a different person or is acting differently, that would be very worrisome," Lavin said.

Masks going to schools to curb H1N1

2009-12-05T12:32:00.000-08:00

California school districts will receive 23 million masks and pairs of gloves to help curb the spread of swine flu, the state schools chief announced Friday.
"We want to keep students, teachers and staff healthy and in school," Superintendent of Public Instruction Jack O'Connell O'Connell said in a statement.
Details of the program were being released at a Los Angeles County warehouse in Santa Fe Springs packed with boxes of disposable gloves and masks.
The items, paid for by federal grants, will be shipped free to 58 county offices of education and to the Los Angeles Unified School District, which is the nation's second-largest district.
They are intended for roughly 10,000 public schools with about 6.3 million students in more than 1,000 districts, said Hilary McLean, a spokeswoman for the California Department of Education.
Stanislaus County's share includes 1,554 boxes of the masks and 1,243 boxes of gloves.
Though they'll be used in the emergency of an H1N1 outbreak, they can also be used in cases where a student or adult has flulike symptoms and is waiting to be taken home, Stanislaus County Office of Education officials said. Schools already have been stocked with other gloves and masks.
The new items will be disseminated to Stanislaus County schools based on their student enrollment, and schools can use them as they wish, officials said.
Shipping of the supplies began late last month, McLean said.
Federal guidelines recommend that students with H1N1 symptoms such as fever, cough and sore throat be sent to a separate office or sick room until they can leave campus.
But it can take several hours before parents can pick up their children, McLean said.
Surgical masks for children
In the meantime, the child will be asked to wear a surgical mask while the school nurse or other staffer will wear a different type of mask and gloves, McLean said.
There have been more than 7,200 cases of swine flu reported in California this year, 366 of them fatal, according to the state Department of Public Health.
Although some counties have reported drops in the number of new swine flu cases, indicating the pandemic may have peaked locally, McLean said schools always can store the masks and gloves in case there's an outbreak of another type of flu.
"Next year, we're sure to have another flu season," she said.

Swine phew

2009-12-05T06:39:00.000-08:00

A TOP scientist last night dismissed fears over swine flu - claiming its death rate may even be LOWER than normal flu.
Bacteriologist Hugh Pennington said the virus - that has killed 54 people in Scotland - "had a lot more publicity than it deserved".
But he warned that H1N1 could still mutate into something far more deadly.
Prof Pennington said: "There's nothing terribly surprising about what it has done except it's not hit the elderly hard - where you'd normally find most flu deaths.
"That is one of the main reasons why there have been so relatively few deaths.
"There is some evidence that some of the elderly may have some protective antibodies from a flu outbreak in the 1950s or earlier. But it has hit kids - and it has also been very localised in its outbreaks."
The professor also claimed the Scottish Government's vaccination programme had not been a waste of money. He said: "The government's plan has worked well - but the virus has not behaved according to the plan.
"Governments have to plan for the worst. I don't think that the money has been wasted - but this virus has had a lot more publicity than it deserves.
"A lot of people - about 30 per cent - get infected and don't even have any symptoms or know they've got it."
But Prof Pennington added it was a "certainty" swine flu would mutate and become much more deadly. Already a new strain has emerged that is resistant to anti-viral drug Tamiflu, adding: "It needs constant monitoring." Figures reveal that 54 people died from swine flu, with 1,200 people being treated for the virus in hospital.
But more than 70 per cent of victims were already weakened by existing medical conditions.
And Health Protection Scotland believes the most recent infection stats show the current outbreak may have already peaked.
The number of people consulting their doctors for flu-like symptoms fell by 18 per cent in a single week and infection rates fell in every health board area except for Fife, where the numbers are stable.
Last night Health Secretary Nicola Sturgeon said: "With our vaccine programme well under way, we are likely to see a fall in infections - but that doesn't mean we can be complacent.
"I would encourage everyone in the priority groups to take advantage of the offer of vaccination."

Flu can be dangerous for diabetics

2009-12-05T01:51:00.000-08:00

People with diabetes are part of the high-risk group for the seasonal flu and H1N1 viruses. Both illnesses can make it difficult for diabetics to keep track of their blood sugar levels.
John Sproat, who has diabetes, said he knows how important it is to get his flu shot every year.
"I don't want to get sick," he said. "I've gotten the flu in the past. It's horrible."
"It is critical that a diabetic get both vaccines," said Dr. Stanley Mirsky, with Lenox Hill Hospital in New York City.
Diabetics are more susceptible to severe cases of the flu, because their bodies have a harder time fighting off infection, doctors say.
The biggest problem for diabetics is keeping blood glucose levels under control. Feeling tired from the flu, though, can mask both low and high blood sugar levels.
"They should make sure they're checking their blood sugar four times a day," Mirsky said.
Diabetics are six times more likely to be admitted to the hospital for seasonal flu and nearly three times more likely to die from it. They account for 12 percent of hospitalizations in the H1N1 breakout.
Diabetics should call their doctor immediately if they have flu symptoms.
Anti-viral medications, such as Tamiflu, can be a life-saver, but diabetics should avoid over-the-counter flu remedies that contain sugar, which can trigger complications.
Doctors said that prevention remains the best defense against flu strains.
"It's just much easier to get the shot and get it over with," Sproat said.
The challenge for many high-risk people is finding the H1N1 vaccine. Most primary care physicians are getting supplies and are limiting it to people in priority groups, which includes diabetics.

Swine Flu Kids Getting Faster Drug Treatment

2009-12-05T01:49:00.000-08:00

More than 80 percent of U.S. children severely ill with H1N1 flu have been treated swiftly with antiviral drugs, a trend that could be saving lives, U.S. health officials said on Friday.
Public education campaigns about swine flu have translated into quicker and better treatment with Tamiflu, Roche AG and Gilead Sciences Inc's influenza pill, they said.
Usually, at most 20 percent of children severely ill with influenza ever get treatment with Tamiflu or GlaxoSmithKline's inhaled drug Relenza, said Centers for Disease Control and Prevention Director Dr. Thomas Frieden.
"In this year it been over 80 percent. That means doctors are getting the message that severely ill children need to be treated," Frieden told reporters in a telephone briefing.
Given within the first day or so of a fever, Tamiflu and Relenza can greatly reduce symptoms. A third drug in the same class, BioCryst Inc's peramivir, has emergency authorization for intravenous use in the most severe cases.
The quick treatment is important, as H1N1 is more likely to infect younger adults and children, as opposed to seasonal flu, which takes it heaviest toll among the over-65s.
"We have already had three times the number of deaths among children than we would (have) in a usual flu season," Frieden said. He said 17 more child deaths from swine flu had been reported in the past week, bringing the total confirmed number of H1N1 pediatric deaths to 210.
But the CDC estimates that more than 500 U.S. children have actually been killed by H1N1 -- far more than in a normal flu season.
MORE VACCINE

Frieden said supplies of H1N1 vaccine should improve in coming weeks and said 73 million doses had now been distributed or were ready for distribution -- still less than half of what had originally been hoped for by this week .
"We expect at least 10 million more doses in the coming week," Frieden said.
So far safety monitoring has shown no worrying side-effects from the vaccine, Frieden said, such as the rare neurological condition called Guillain-Barre Syndrome linked to a 1976 vaccination campaign against a different strain of swine flu.
"The likelihood that we will have a 1976-like problem with this year's H1N1 vaccine is vanishingly remote," Frieden said.
Frieden said some school districts had managed to vaccinate virtually every student. "That's an important accomplishment for this year and for the future," he said." School-based vaccination programs are unusual in the United States and this year's has been difficult to organize.
The World Health Organization said separately on Friday that the pandemic appears to have peaked in Canada and the United States.
"Worldwide more than 207 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 8,768 deaths," WHO said in a statement on its website at http://www.who.int.
"In Europe, widespread and intense transmission of pandemic influenza virus continued to be observed across most of the continent," it added. "In Western and Central Asia, influenza transmission remains active."
Both WHO and the CDC note that the confirmed number of deaths and cases are a small fraction of the actual numbers.

Pandemic (H1N1) 2009 briefing note 18

2009-12-03T08:55:00.000-08:00

WHO has been informed of two recent clusters of patients infected with oseltamivir-resistant H1N1 viruses. Both clusters, detected in Wales, UK and North Carolina, USA, occurred in a single ward in a hospital, and both involved patients whose immune systems were severely compromised or suppressed. Transmission of resistant virus from one patient to another is suspected in both outbreaks.
The emergence of drug-resistant influenza viruses in severely immunosuppressed or immunocompromised patients undergoing antiviral treatment is not unexpected and has been well documented during seasonal influenza. Virus replication can persist in such patients for prolonged periods of time despite antiviral treatment, creating an environment in which drug-resistant viruses can readily be selected. This phenomenon has also been observed for the pandemic (H1N1) 2009.
Upon receipt of the reports, WHO organized a telephone conference with officials and staff from the hospitals and experts in clinical medicine, epidemiology, and virology to discuss the two outbreaks. Particular attention is being given to the best treatment options for immunocompromised patients who become infected with the pandemic virus.
The outbreaks
The Wales outbreak, which was detected in late October, involved eight patients. All of these patients were hospitalized because of severe haematological disorders. No deaths occurred. Three of these patients remain in hospital, with one being treated in intensive care.
In the USA outbreak, which involved four severely immunocompromised patients, cases occurred in a two-week period between mid-October and early November. Three of the four cases were fatal, but the role of H1N1 infection in contributing to these deaths is uncertain.
All of the resistant viruses carried the same H275Y mutation, indicating resistance to oseltamivir but susceptibility to the second antiviral drug, zanamivir.
Ongoing investigation
The outbreaks are being further investigated to determine the mode of transmission within the wards and to ensure that resistant viruses have not spread to staff, other patients in the hospitals, or into the wider community. Results to date are reassuring.
No illness in staff caring for these patients has been detected, suggesting that the resistant virus does not spread easily to otherwise healthy people, especially when good measures for infection control are in place. Moreover, intensified surveillance has found no spread to other wards within the two hospitals or into the wider community.
Modified treatment recommendations
The experts agreed that severely immunocompromised patients need to be regarded as an especially vulnerable group. These patients are highly susceptible to infection, particularly difficult to treat, and especially likely to develop resistance.
As early signs of influenza may be masked by symptoms associated with underlying disorders or their treatment, the experts further agreed that doctors treating such patients should operate with a high level of suspicion for influenza virus infection and be especially vigilant for the rapid development of oseltamivir resistance.
In these patients, standard treatment doses and duration for treatment with oseltamivir are unlikely to be sufficient. Though clinical judgement is important, doses may need to be increased and continued, without interruption, for the duration of acute illness. Zanamivir should be considered as the treatment of choice for patients who develop prolonged influenza illness despite treatment with oseltamivir.
Once oseltamivir resistant virus has been detected in a ward treating severely immunocompromised patients, doctors should consider switching to zanamivir as the antiviral drug of first choice for treatment and when considering post exposure prophylactic treatment of other patients on the ward.
The experts were emphatic in their recommendation that health care staff, carers and family contacts of patients be vaccinated against pandemic influenza.
Vigilant monitoring needed
WHO recommends vigilant monitoring for the development of oseltamivir-resistant viruses and for any changes in the transmissibility or pathogenicity of these viruses. Experience with seasonal influenza viruses shows that resistant viruses can quickly spread within the general population and become established, rendering one or more antiviral drugs ineffective.
Experience acquired since the initial characterization of the H1N1 pandemic virus in March shows that the neuraminidase inhibitors, oseltamivir and zanamivir, when administered early, reduce the risk of complications and may also improve the clinical outcome in patients with severe disease. This experience underscores the need to protect the effectiveness of these drugs by minimizing the occurrence and impact of drug resistance.
WHO received the first report of an oseltamivir-resistant pandemic virus in July. In general, cases of oseltamivir resistance have been geographically dispersed, sporadic and not linked to one another. The number of these events has been steadily increasing, in line with recent increases in influenza activity in many parts of the world and a corresponding increase in the administration of antiviral drugs.
Within the past two weeks, the number of documented cases of oseltamivir resistance in H1N1 viruses has risen from 57 to 96. Around one third of these cases occurred in patients whose immune systems were severely suppressed by haematological malignancy, aggressive chemotherapy for cancer, or post-transplant treatment. The clusters in the two hospital wards should be viewed in the context of these overall trends. Although all incidents of oseltamivir resistance merit investigation, no evidence suggests that events to date constitute a public health threat.

Kobe's Santa knows what you want: Tamiflu

2009-12-02T23:31:00.000-08:00

KOBE (Kyodo) In the spirit of this Christmas season, the large Santa outside a popular old Western-style house in Kobe's Kitano district brought an unconventional gift: a box of Tamiflu.
The 3.5-meter Santa Claus doll hangs from the exterior of Uroko no Ie (House of Scales), which was built around 1905 as a rental house for rich foreign residents and is now open to tourists, who routinely flock to the district.
This year, Santa is wearing a surgical mask and at the top of his sack a box of flu medicine can be glimpsed, echoing people's fear of swine flu, which has already infected more than 10 million people nationwide.
"We'd like people to enjoy a quiet Christmas without catching diseases," said a manager of the house.

22 Million Americans Have Been Ill With H1N1 Influenza

2009-12-02T13:18:00.000-08:00

The CDC has updated its estimates related to the spread of the novel influenza A (H1N1) virus, and the numbers are staggering.
The agency estimates that from April to mid-October, there were 22 million H1N1 illnesses in the United States, with 98,000 hospitalizations and 3,900 deaths, according to Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases.
People with diabetes represent a large percentage of H1N1 cases, Schuchat said during a Nov. 12 media briefing. Individuals with diabetes accounted for 12 percent of all hospitalizations associated with H1N1 infection during this period, and 19 percent of adults hospitalized with the infection had diabetes. Moreover, one-fourth of people with diabetes who were hospitalized with H1N1 illness required intensive care.
But, according to Schuchat, people with diabetes can take a number of steps to protect themselves from influenza and its complications.
The CDC recommends that people ages 6 months to 64 years who have any type of diabetes should be vaccinated against H1N1 flu when the vaccine is available in their communities. When supply of the vaccine increases, patients with diabetes who are 65 years and older also should get the vaccine. All people with diabetes ages 6 months and older, including the elderly, also should receive the seasonal flu vaccine.
The agency also recommends that people ages 2 years and older who have diabetes or other chronic conditions also should receive the pneumococcal polysaccharide vaccine because influenza infection can increase the likelihood of developing bacterial pneumonia. The vaccine may be administered at the same time as influenza vaccines. CDC recently released a letter to physicians encouraging them to vaccinate patients with these indications.
People with diabetes who are suspected to have seasonal or H1N1 flu should receive antiviral treatment. The CDC said physicians should not wait for the lab results to confirm the type of influenza before prescribing antiviral medications. Oseltamivir (Tamiflu) and zanamivir (Relenza) both can be taken by people with diabetes.
H1N1 has taken a heavy toll among individuals with asthma, as well. CDC Director Thomas Frieden, M.D., said during a Nov. 3 media briefing that among patients with asthma who have been hospitalized for H1N1 infection, only about one-half sought medical care at the onset of their illness.
"If you have asthma or another underlying condition, seek care promptly when you have fever with cough," Frieden said.
Young children also have been hit hard by the novel virus. Schuchat said during the Nov. 12 media briefing that the CDC estimates that 8 million children had contracted the virus as of Oct. 17, with about 36,000 hospitalizations and 540 deaths.
Among adults ages 18-64, there were an estimated 12 million illnesses, with about 53,000 hospitalizations and 2,900 deaths. Adults 65 and older accounted for about 2 million illnesses, 9,000 hospitalizations and 440 deaths.
Schuchat said the CDC plans to release updated estimates every three to four weeks.

Roche Announces Shipments of New Supplies of Children's Tamiflu(R) in the U.S.

2009-12-02T12:28:00.000-08:00

Tamiflu Oral Suspension (Liquid) & Low Dose Capsules Begin Arriving at Pharmacies
SOUTH SAN FRANCISCO, Calif., Dec. 2 /PRNewswirel/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping additional quantities of Tamiflu® (oseltamivir phosphate) oral suspension (liquid). The added supplies of Tamiflu will begin arriving in pharmacies nationwide and will continue to roll out to wholesale and retail pharmacies during the next several weeks. These shipments add to the millions of treatment courses of the adult-sized capsules already available nationwide and significant quantities of smaller, lower dose capsules shipped in November. Together, the formulations provide various dispensing options for treating children with influenza.
Tamiflu is available in 75 mg capsules for adults, 30 mg and 45 mg capsules for children or oral suspension (liquid) for children or people who have difficulty swallowing capsules. Roche continues to make all forms of Tamiflu, and increasing quantities of Tamiflu oral suspension will become available over the next several weeks through the beginning of next year. The small, low-dose capsules may be easier for children to swallow or may be opened and mixed with sweetened liquids, such as regular or sugar-free chocolate syrup, by parents or caregivers. Also, pharmacies can convert the adult (75 mg) size capsules into a liquid for children if neither the liquid nor small capsule forms of Tamiflu are in stock.
"As influenza continues to be widespread throughout the U.S. and the winter flu season nears, we remain committed to making sure there is enough Tamiflu to meet the needs of both adults and children," said Alexander Hardy, vice president, Anti-Infectives, Genentech, a member of the Roche Group. "We are hopeful that news of these shipments will provide added reassurance to parents that there are Tamiflu options available for their children when they need it."
Tamiflu attacks the flu virus at its source, preventing it from replicating in the body. Recommendations from the U.S. Centers for Disease Control and Prevention (CDC) on use of antivirals, such as Tamiflu, in management of seasonal and pandemic H1N1 influenza are available at http://www.cdc.gov/H1N1flu/recommendations.htm.
Tamiflu Manufacturing Capacity
Roche has invested significantly to increase its global manufacturing capacity to meet Tamiflu demand during pandemic preparedness and response. The expanded global manufacturing network, which includes 19 partners in 10 countries on three continents, has enabled Roche to boost Tamiflu production 15-fold since 2004. As a result, Roche has the ability to produce 400 million treatment courses annually, roughly 33 million courses per month if required. At the request of the U.S. Department of Health and Human Services (HHS), Roche established the capacity to produce 80 million treatment courses from start to finish in the U.S. each year. Roche continues to work with the U.S. government to provide for the Strategic National Stockpile of antivirals for pandemic preparedness and response.
Worldwide Tamiflu Access
To facilitate availability of Tamiflu on every major continent, Roche has granted four sub-licenses to generic manufacturers for production in China, India and Africa. Roche has donated a total of 10.75 million Tamiflu treatment courses to the World Health Organization (WHO) and offered substantially discounted pandemic pricing to all governments.
About Tamiflu
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have had flu symptoms for no more than two days. Tamiflu is also indicated for the prevention of influenza in patients one year and older. Tamiflu is not a substitute for annual early vaccination as recommended by the CDC. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu.
Tamiflu Safety Information
There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.
Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.
No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.
Efficacy of Tamiflu has not been established in immunocompromised patients.
Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.
The most common adverse events reported in >1% of patients treated with Tamiflu and more commonly than in patients treated with placebo are:
* Treatment of adult and pediatric patients: nausea, vomiting
* Prophylaxis of adult and pediatric patients: nausea, vomiting, abdominal pain
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.

Drugstores cut prices of Tamiflu

2009-12-02T12:22:00.000-08:00

Some drug stores are cutting the price of the liquid version of Tamiflu after reports of price gauging.
Walgreens and CVS among those dropping the price. Walgreens has cut its prices by nearly 20 percent and CVS by nearly 10 percent.
State investigators are looking into whether drugstores are price gauging tamiflu in the wake of the H1N1 Flu pandemic.
The price of Tamiflu at CVS is now $74.99, down from around $83. The price at Walgreens was $94.49.
Tamiflu is readily available in capsule form, there is a shortage of the liquid version, which is easier for kids to take.

What You Need To Know About The Swine Flu Virus

2009-12-02T11:16:00.000-08:00

Today we are ever more at a greater risk from the various strains of the flu virus than we have for a very long time. We had concerns over bird flu, and more recently swine flu has become a major health problem. Swine flu is of more concern than bird flu. It was feared that bird flu may mutate into a strain that would become infectious in humans, apart from a few cases, this has not materialized so far.
Swine flu is of more concern, it is able to spread from person to person making it an extremely serious health problem. Swine flu (influenza A (H1N1)) is a flu virus which infects pigs. Outbreaks of swine flu in pigs doesn’t normally infect people although it can happen sometimes.
Swine flu is a new type of virus and therefore is extremely dangerous to people. No one has been in contact with this particular strain before, and therefore no one has developed any immunity to this virus. Without built in immunity a disease is life threatening, as our bodies are unable to defend against the virus. Everyone is vulnerable, including healthy adults as well as children and elderly citizens.
Swine flu could easily give rise to a pandemic flu situation. Pandemic flu situation occurs when an influenza viral strain develops that is very different from previous flu strains that very few, if any, humans have any sort of immunity to. This lets the influenza virus to spread rapidly in the population.
Seasonal flu and swine flu are different as detailed below Ordinary flu happens yearly, usually in the winter. Approximately between 10 and 15 percent of the population will be effected and most will recover without treatment in about 1 to 2 weeks.
A pandemic outbreak of influenza affects far more people with up to half the population affected. Pandemic flu affects people of every age.
Swine flu symptoms are very similar to the symptoms of ordinary influenza. Symptoms can include a sudden onset of a fever, a cough or a shortness of breath. Other symptoms that may also be present can include headaches, sore throats, aching muscles, chills, sneezing, runny nose, loss of appetite and tiredness.
What precautions should you take. Anyone displaying cold or flu symptoms should take some easy, but very important precautions. The influenza virus spreads between people from the tiny droplets from the nose and mouth when someone sneezes or coughs. This is the way viruses like swine flu are spread from person to person. Using your hands to cover your nose or mouth when you sneeze or cough is not effective enough. The virus simply sit on your hands, then everything you touch afterwards becomes contaminated. Anyone touching the same place will pick up the virus and become infected. Always use a handkerchief or tissue. A disposable tissue is much better, the tissue should be disposed safely as soon as possible, and always use a fresh tissue when you sneeze or cough again.
There are currently no vaccinations to prevent anyone catching swine flu. Swine flu is a new strain of virus. Therefore the annual vaccination against the normal seasonal flu is not effective for swine flu. Once the type of influenza causing swine flu is identified, it will take many months to produce. By this time, it could have mutated into a different type.
The only real effective precaution you can take against swine flu is Tamiflu. Tamiflu is not guaranteed for the prevention of flu, but after someone has been exposed to someone else who has the flu virus, Tamiflu may help to stop the flu virus making you sick. If Tamiflu is administered in the first 2 days of acquiring the swine flu virus, it will help to stop the virus spreading throughout the body, thereby reducing the symptoms and the risk associated with the virus. Governments worldwide are stocking Tamiflu, but these supplies will be used in treating important workers before the general population.
however you buy Tamiflu online, if the situation arises you can protect yourself and family as much as is possible. It can’t be emphasized enough, Tamiflu needs to be taken as soon as is possible to be effective, delays in treatment will reduce how effective Tamiflu is.
Remember that swine flu is a global danger. If an outbreak becomes global it is a possibility that supplies of Tamiflu may be low and may possibly not meet a large worldwide demand. Until a vaccine is found and manufactured in the amounts needed, Tamiflu is the most effective treatment for the swine flu virus, it would therefore be prudent to buy Tamiflu in advance if you think you are at risk.
Disclaimer: This post is based on information freely available in {the popular#the} media and medical articles related to swine flu. Nothing in this post is intended to be or should be construed to be medical advice. For medical advice you are encouraged to consult your healthcare worker.

Swine Flu Waning, But Could Return

2009-12-02T05:30:00.000-08:00

A U.S. health official said Tuesday that H1N1 swine flu infections appear to be on the wane nationally, but many experts agreed the virus could return in force later this winter.
The flu is now widespread in 32 states -- down from 43 states the week before, Dr. Thomas R. Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC), said during an afternoon press conference. In addition, H1N1 vaccine supplies are increasing.
"We are going from a time where there was lots of disease and not enough vaccine to a time where disease is gradually decreasing, and we are having a steady increase in the amount of vaccine that is available," Frieden said.
While there are fewer new cases of the swine flu, it is still not gone, and it may return, he said.
Flu is highly unpredictable, Frieden said. Of the experts the CDC polled on the odds of another surge, about 50 percent said there would be one, and about 50 percent said there would not be one -- and one expert said "flip a coin."
Frieden noted that in the flu pandemic of 1957-1958, cases surged at the start of the school year and then waned, but surged again from December to February.
There is no way of telling whether or not that will happen this year, he said. But people should take advantage of the current lull in flu activity to get vaccinated just in case the flu comes back.
Despite a decline in the number of cases, "we are far from out of the woods," Frieden said.
Right now, close to 70 million doses of vaccine are available, with more on the way, and most people should be able to get vaccinated this month, he said.
And there was one more piece of good news. Duke University Hospital in Durham, N.C., which last week reported four cases of very ill patients with H1N1 that did not respond to the antiviral Tamiflu, said in a news release Tuesday that it has uncovered "no additional cases" of the potentially dangerous, drug-resistant strain. No such cases have appeared throughout the state either, the university said.
But not of all the news has been good: 35 flu-related pediatric deaths -- 27 from lab-confirmed H1N1 -- were reported to the CDC this week, bringing to 234 the total number of flu-related child deaths since April. According to the Associated Press, this week's jump in pediatric flu deaths is the largest one-week increase since scientists first spotted the H1N1 virus in April.
Overall, hospitalizations and deaths continue "to be higher than expected for this time of year," the CDC said.
These reports follow on news last week that the ongoing pandemic may be driving a recent spike in dangerous pneumonias among younger patients.
"We are seeing an increase in serious pneumococcal infections around the country," Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said during a press conference last Wednesday. "Pandemics put us at risk for not just flu problems, but also bacterial pneumonia problems," she added.
These bacterial infections commonly infect the lungs and sometimes the bloodstream. During most flu seasons, secondary infections such as pneumonia typically occur in people 65 and older, she said.
However, in this pandemic the increase in pneumococcal infections is being seen primarily among younger people, Schuchat said.
Questions about the safety of the H1N1 vaccine have lingered, but Schuchat sought to assuage any fear with some of the first safety data available since mass vaccinations began.
"So far, everything we have reviewed is extremely reassuring," she said during last Wednesday's press briefing. "In our look at all of the safety data in the U.S. so far, we are seeing patterns that are pretty much exactly what we see with the seasonal flu vaccine."

State offers cheaper H1N1 medication

2009-12-01T09:01:00.000-08:00

New York state and more than 1,200 pharmacies are providing antiviral medication for H1N1 flu for $5 or less, instead of $100, for people who are uninsured or underinsured, officials announced Monday.
Even the $5 fee will be waived for those who can't afford it. The antivirals, called oseltamivir (Tamiflu) and zanamivir (Relenza), are prescription drugs that can help prevent and treat flu, reducing the risk of serious complications and death. The drugs are prioritized to people with more severe flu illness, such as people hospitalized with flu, and to people at increased risk of influenza-related complications. The treatment is most effective when begun within 48 hours of the start of flu symptoms.
The state Department of Health is distributing about 125,000 of the five-day treatment courses of antivirals from the state emergency stockpile this week to participating pharmacies, Gov. David A. Paterson said Monday. The state in May distributed a much smaller amount to county health departments for use by hospitals and other health care providers.
Those for whom healthcare providers might prescribe antiviral medications are: pregnant women; women who have given birth in the past two weeks; children younger than 5 and especially children younger than 2; people 65 years and older; people with respiratory conditions, including asthma, chronic lung disease or chronic obstructive pulmonary disease; people with other underlying health conditions, including cancer, heart disease, diabetes, blood disorders, kidney disorders, liver disorders, neurological disorders or neuromuscular disorders (including muscular dystrophy and multiple sclerosis); people with weakened immune systems (including those with HIV/AIDS); and people under 19 who are on long-term aspirin therapy.

Tamiflu Shortage and Solution

2009-12-01T08:06:00.000-08:00

A shortage of the liquid form of Tamiflu that is used for children has created additional concern for parents as the official flu season gets underway.
Roche, the company that makes Tamiflu, tells Fox 5 there have been spot shortages of the antiviral drug for kids. The company is actively producing all forms of Tamiflu and is currently shipping out more of the liquid version.
In the meantime, solutions exist if you can't get your hands on the liquid form. Because of this shortage, many pharmacies across the country are now creating their own liquid Tamiflu. The process is called compounding. That is where a pharmacist mixes medications and other ingredients or flavors to fit the needs of a patient.
Roche and the FDA have given 100 percent approval to pharmacists in compounding Tamiflu. The FDA and CDC both say the compounded version is safe and effective.
The CDC is also helping parents make their own liquid form of the drug by letting them know how to mix the pediatric capsules.

Swine flu still down in U.S. but 198 children dead

2009-12-01T03:33:00.000-08:00

Swine flu continues to wane across the United States, but it has killed more than 30 children since the last count, U.S. health officials said on Monday.
The latest update on the H1N1 virus, posted at cdc.gov/flu/weekly/, shows the infection is still at epidemic levels but below its October peak, the Centers for Disease Control and Prevention reported.
Since March, 198 children have been reported killed by H1N1, although the true number is likely far higher because many people with the flu don't go to the doctor and only a few who do are tested for swine flu.
The CDC said just over 20 percent of specimens sent for testing from patients with flu-like illness were positive for H1N1 swine flu, meaning that 80 percent of patients had something else. At the worst, this proportion was over 30 percent.
Swine flu continues to dominate, with 99 percent of flu cases being due to the H1N1 strain.
"The proportion of outpatient visits for influenza-like illness was 4.3 percent, which is above the national baseline of 2.3 percent," the report reads.
The CDC got reports in the week ending November 21 of 35 children who died, although one died from seasonal influenza in March -- bringing to 128 the confirmed pediatric death toll from seasonal flu in 2008-2009.
"A total of 198 deaths in children associated with 2009 influenza A (H1N1) virus infection have been reported to CDC," the report reads.
Many of the children who died had bacterial infections known to worsen a flu infection. Thirty-one percent of the children who died and who were tested for bacterial infections had one, and nearly a third of these had Staphylococcus aureus.
The virus remains mostly treatable by oseltamivir, the flu pill made by Roche AG and Gilead Sciences under the brand name Tamiflu. "A total of 23 cases of oseltamivir resistant 2009 influenza A (H1N1) viruses have been identified in the United States since April 2009," the CDC said.
All viruses tested, including those resistant to Tamiflu, can be treated with Relenza, GlaxoSmithKline Plc and Biota's inhaled drug also known as zanamivir.
The CDC estimates that more than 22 million Americans have been infected with H1N1 and that 3,900 have died. The U.S. government has ordered 250 million doses of vaccine but companies have been struggling to make it, leading to widespread shortages.
The World Health Organization reports that more than 207 countries and overseas territories or communities have reported laboratory-confirmed cases of H1N1, with more than 7,820 confirmed deaths -- numbers the WHO says are the tip of the iceberg.

Amid probe, pharmacies cut back on liquid Tamiflu price

2009-12-01T01:37:00.000-08:00

Walgreens has reduced its prices by nearly 20% and CVS nearly 10% for a scarce liquid form of the H1N1 drug Tamiflu amid state investigations into potential price gouging.
Connecticut Attorney General Richard Blumenthal still questions whether the pharmacy chains and others are charging fair prices. "I'm delighted they are reducing their prices, but they may have an obligation to reduce them even further," Blumenthal said Monday. He sent investigative letters Nov. 23 to Walgreens, CVS and Rite Aid and said his investigators are interviewing independent pharmacists.
A USA TODAY telephone survey last month of more than 100 pharmacies in six states found Walgreens had among the highest out-of-pocket prices to make, or "compound," the same child-strength liquid prescription.
The survey, published Nov. 18, found prices ranged from $43 to $130; Walgreens' price was $94.49. A follow-up phone survey by the newspaper in recent days to a dozen pharmacies that had given high price quotes found Walgreens stores had reduced their prices to $75.69.
Walgreens spokesman Jim Cohn said the chain is "committed to offering competitive pricing" and "made the decision to adjust the price for compounded Tamiflu prescriptions."
The price reduction occurred around Nov. 19 or 20. He noted that Walgreens' price structure for compounded medications had been unchanged since 2006.
CVS this week set $74.99 as the chainwide price, down from about $83, for the dose and duration of the sample prescription used in USA TODAY's survey, spokeswoman Carolyn Castel said.
Rite Aid spokeswoman Cheryl Slavinsky said Monday the chain's price is about $61 to fill USA TODAY's sample prescription, but she didn't know whether that price had changed in recent weeks.
Although Tamiflu capsules are readily available, there's a shortage of manufacturer-made Tamiflu liquid, which is easier for children to swallow. Many pharmacies are mixing capsules with a sweet syrup to make their own version, an emergency measure approved by the Food and Drug Administration.
Pricing factors include the varying costs of Tamiflu capsules and extra fees to make the liquid.
Blumenthal is asking pharmacies to detail their pricing structures and any changes since the recent shortage or since the swine flu pandemic began in April.
USA TODAY's follow-up calls to other pharmacies did not find additional price drops.
Michigan Attorney General Mike Cox warned Michigan consumers last week to shop around for the drug after his investigators used USA TODAY's methodology to survey 50 pharmacies in five cities and found similar price variations. Cox called the high prices at some pharmacies "disturbing" and said investigators will be probing further.
The Mississippi attorney general also is investigating.

New Flu, Old War

2009-11-30T12:25:00.000-08:00

On May 20, several weeks after influenza A virus subtype H1N1 broke out in Mexico City in March this year, Taiwan recorded its first case when the Central Epidemic Command Center (CECC) confirmed the flu had been diagnosed in a 52-year-old Australian man who had just arrived from New York City. The next day, two Taiwanese women—one arriving from New York and one from San Francisco—were also found to have contracted the virus. All three cases of H1N1 were detected at the fever screening station inside Taiwan Taoyuan International Airport, where they showed temperatures exceeding 38 C. After this initial screening, each of the passengers was sent to Taoyuan General Hospital, which is operated by the Department of Health (DOH).
On July 2, the DOH’s Centers for Disease Control (CDC) announced the detection of the H1N1 virus in two specimens collected from residents of communities in Taiwan, showing that local transmission of H1N1 had begun. The first severe case of the flu in Taiwan was reported on July 17 in a 34-year-old man, and the first fatality occurred when a 39-year-old man died on July 31. Vice Premier Eric Li-luan Chu took over from Yaung Chih-liang, minister of the DOH, as CECC chief in early September as students started returning to schools, which are prone to outbreaks. As of mid-October, Taiwan had recorded around 360 cases in which H1N1 patients had been hospitalized. Of those patients, 24 died, but most recovered and are free of complications.
H1N1, commonly known as swine flu in some countries, began its global spread as health authorities were preoccupied with another flu associated with animals, bird flu. The name swine flu is somewhat misleading, however, as H1N1 is a mixture of two influenza strains found in pigs together with one found in humans and one in birds. Pork vendors around the world have complained about the flu’s common name and point out that the virus cannot be contracted by eating cooked pork. In Taiwan, the emerging disease is usually called “H1N1 flu,” or simply the “new flu.”
Despite the heavy media coverage, H1N1 has proven similar to other, more mundane types of flu, as like them, it is spread by coughing, sneezing or touching the nose or mouth with contaminated hands. An H1N1 patient suffers much like one afflicted with normal seasonal flu, which usually causes fever, a sore throat, a headache and muscle pain. Actually, despite the somewhat elevated level of public anxiety over H1N1’s seriousness, the great majority of those who have contracted the disease in Taiwan have recovered fully after developing only mild symptoms.
In June, after the World Health Organization (WHO) declared a global but mild pandemic, the CDC shifted H1N1 from its most severe category of infectious diseases, bumping it down to the fourth most-severe level. Taiwan’s Communicable Disease Control Act designates five levels of epidemics according to standards such as the potential number of fatalities, infection rate and speed of transmission. The CDC’s most serious category of communicable diseases includes smallpox, plague and severe acute respiratory syndrome (SARS), which hit Taiwan hard in 2003. Level one communicable diseases require immediate case reporting and quarantining, while level four diseases such as H1N1 require regular, comprehensive monitoring of factors such as transmission rates within communities, genetic mutation of the virus and resistance to antiviral medicines.
Wu De-lon, president of the Taiwan Hospital Association and a top advisor for the Chang Gung Healthcare System, one of the largest medical institutions in Taiwan, points out that although it is caused by a new virus, H1N1 flu is less deadly than the average seasonal flu, which kills 4,000 to 5,000 people each year in Taiwan, and thus is not a cause for excessive alarm. “Some people are easily panicked by the more sensational, exaggerated views in the media,” Wu says. “But the severe impacts that some academics and health experts warned of haven’t materialized yet.”
DOH Minister Yaung Chih-liang points out that for the government, the principal goals of handling the outbreak are to build a comprehensive picture of the impact of H1N1, including infection rates and locations, as well as give the public access to adequate, transparent information. “The most difficult thing to do is developing well-balanced control measures,” Yaung says. “We cannot afford to underestimate the risks of infection on the one hand, but we don’t have to treat it like a horrible enemy and cause panic for the general public on the other.”
For one thing, Yaung does not think that students should be prevented from attending school on a national scale. Currently, according to guidelines for schools from kindergarten to high school, the government has instituted the “three-two-five” policy, under which a class is suspended for five days, including weekends and holidays, if two or more students in that class are diagnosed with H1N1 within a span of three days. According to the Ministry of Education, in mid-October around 460 classes in about 285 schools were closed, accounting for 0.3 percent of all classes. As for colleges and universities, less than 0.1 percent of classes had been suspended.
Designated Flu Clinics
For his association’s member hospitals, Wu says the most important thing for the screening system to accomplish is to identify H1N1 patients whose illnesses tend to worsen over time instead of improve, as these cases are much more severe. Fortunately, according to the DOH there are around 3,000 designated flu-care clinics around the country, which increases the chances that medical professionals trained in infectious diseases will be able to identify the serious cases. “With these clinics available in neighborhoods, people don’t have to go to big hospitals for initial treatment for flu,” Yaung says.
The minister is also quite confident about the ability of the National Health Insurance (NHI) program to check the spread of H1N1. Taiwan’s universal healthcare system was launched in 1995 and, despite some financial difficulties, currently covers virtually the entire population. “Going to a doctor is not a problem for our people,” Yaung says, “and the [H1N1] medicine is also ready for use.”
In early September, the DOH began to release 250,000 doses of the antiviral drug Tamiflu, which were purchased from Swiss pharmaceutical company Hoffmann–La Roche Ltd. to treat patients in the early stages of H1N1 infection. The Tamiflu was distributed to local governments and clinics designated by health authorities in proportion to local populations. Since coverage for Tamiflu treatment was included in the NHI program in mid-August, there has been an increasing demand for the drug. In order to prevent hoarding, the CDC has directed that clinics must pay for the antiviral in cash within three months and cannot return any unused supplies. Also, the CDC has purchased another 2.68 million doses of Tamiflu from Roche for delivery to Taiwan by the end of this year.
The DOH’s decision to distribute Tamiflu to medical units at the grassroots level was welcomed by Chen Chien-jen, former DOH minister and a distinguished research fellow at Academia Sinica’s Genomic Research Center in Taipei. The epidemiologist points out that when H1N1 is detected early, especially in patients with mild symptoms and weaker contagion, it is much more effective to give them antivirals like Tamiflu than to wait and treat them by other means if their case worsens later. Chen says he hopes that there will be a sufficient amount of antivirals to treat each new flu patient within the initial “golden 48 hours” when the drugs are most effective. “That way we can wait patiently to release a vaccination,” he says.
Domestic Vaccine
In its preparations for H1N1, Taiwan has further matched WHO standards through its newfound ability to produce vaccines. In addition to five million doses of H1N1 vaccine purchased from Swiss pharmaceutical company Novartis International AG, 10 million doses were ordered from Adimmune Corp., a domestic vaccine manufacturer headquartered in Taichung County, central Taiwan. Clinical trials on humans of Adimmune’s vaccine were scheduled to wrap up in November.
H1N1 vaccinations using the Novartis or Adimmune product were scheduled to begin in Taiwan in November this year, with their administration proceeding according to an order established by the DOH that prioritizes certain occupational and age groups. Typhoon Morakot disaster survivors and healthcare and infection control personnel were given top priority, followed by infants from six months to one year old, pregnant women, preschool children, people above the age of 7 with major illnesses or injuries, elementary school students from 7 to 12 years old, junior high school students from 13 to 15 years old, high school students from 16 to 18 years old, people from 19 to 24 years old, people above the age of 25 with certain critical illnesses such as diabetes and cardiovascular, pulmonary, liver and kidney disease, people from 25 to 49 years old, people from 50 to 64 years old, and people above the age of 65.
The vaccinations, which are administered free of charge, are scheduled to run through February 2010. The Taiwan Hospital Association and Taiwan Medical Association have vowed to help promote the government’s vaccination campaign to further slow the spread of the disease. According to a survey released by the CECC in early October this year, 60 percent of the respondents said they were willing to be vaccinated, while 17 percent said they would consider it. DOH Minister Yaung notes that, like the NHI program, all of the government’s measures to contain H1N1 apply not only to Taiwan citizens, but also to all legal residents. Although the number of purchased vaccinations is not sufficient to inoculate all of Taiwan’s 23 million people, some local health authorities believe that the program will produce a collective immunity effect that will help protect those who do not receive them.
At around the same time Tamiflu distribution began in September this year, the CECC directed that 2 million facemasks be sent to convenience stores around Taiwan for sale at the mandated retail price of NT$6 (US$0.18) each, following the first such facemask release in early May. In general, while facemasks may not prove overly effective in preventing wearers from getting H1N1, for those who have already contracted the virus, the masks stop coughs and sneezes from expelling infected droplets into the air, one of the prime vectors of transmission. Yaung says that the CECC’s distribution programs are designed to facilitate circulation of the masks, as is the case for antiviral drugs, through regular market mechanisms so that retailers do not hesitate to make their stock available to consumers. According to a survey conducted by the CECC, about 80 percent of the respondents had purchased facemasks by early October this year, with the other 20 percent mostly from low-income households. Through cooperation with local civil affairs authorities, low-income households were scheduled to receive a box of 50 facemasks free of charge in November.
The CECC survey also showed that people in Taiwan have good knowledge about preventing the spread of H1N1. Among other things, more than 90 percent of those surveyed were aware of the appropriate methods of avoiding infection, including washing their hands frequently, trying not to touch their eyes or nose with their hands and understanding how to seek medical care. More than 90 percent of the people surveyed also knew how to prevent passing H1N1 to others, including staying home if they get sick, taking medications as instructed by doctors and wearing a mask when going out. Yaung says he believes that the knowledge and adaptable attitude of Taiwanese are good weapons against a possible epidemic. “Viruses are a force of nature,” the minister says. “They’re just another of the numerous barriers that humans have to use their intelligence to overcome for a sustainable existence.”

Tamiflu Still Number One Say WHO

2009-11-30T11:57:00.000-08:00

The World Health Organisation wants everybody to know that they are standing by the influenza medication Tamiflu and have not changed their recommendations because of the few isolated cases of Tamiflu resistance experienced in the UK, the United States and other countries. The WHO made it clear that Tamiflu was still the most effective defence against the H1N1 swine flu virus and that a change of policy would not be beneficial.
In the UK and the US a number of cases which didn’t respond to Tamiflu have caused concern but this does not necessarily mean that the Tamiflu was not working because it could have been that the individual patients had compromised immune systems due to other illnesses. In fact four Americans who didn’t respond to Tamiflu were actually being treated for cancer and a number of other individuals in the UK were also being treated in hospital for other conditions which could have a bearing on why the Tamiflu didn’t work.
Dr. Keiji Fukuda who heads the influenza section at the World Health Organisation said that they were looking into these individual cases and therefore could not to jump to conclusions at present. There has been plenty of speculation about possible mutations of the H1N1 swine influenza virus but most of it is based on media hype as opposed to logical science.
It is likely that the virus will continue to mutate but just because it changes slightly does not mean that Tamiflu will automatically be rendered ineffective.
Tamiflu even works against the deadly H5N1 bird flu virus which kills about 50 percent of those who get it making it the most deadly influenza virus known to man. On the other hand the swine influenza virus while serious does not kill nearly as many people as some people like to speculate. Nevertheless what makes the swine influenza virus dangerous is that certain sections of the population for example obese individuals are more likely to become seriously ill or even die from it.

Swine flu mutation reported in Italy

2009-11-30T11:51:00.000-08:00

The Italian Health Ministry reported the country's first case of a mutant form of swine flu on Monday.
The ministry said the variation of the A(H1N1) virus was identical to one reported in Norway on November 20. On Friday, France reported the death of two people infected by the same mutation.
The A(H1N1) variation was found three or four months ago in a patient in Monza, near Milan, Italian Deputy Health Minister Ferruccio Fazio said in comments reported by ANSA news agency.
"The Higher Institute of Health has examined around 100 strains (of the virus) found in recent months in patients from all over Italy and up to now the mutation has only been found in one patient," the ministry said in a statement.
"Italian data suggest that at the moment the mutation in question is not dominating serious and fatal cases of the virus. Furthermore, the mutation seems to be sporadic and does not appear to be spreading," the ministry said.
Vaccination and anti-viral treatments were still effective against the mutation, the ministry said.
"Only vaccination protects us from the virus, which is likely to become more dangerous with mutations," Fazio said.
The Italian health institute said it had found one case of resistance to the Tamiflu antiviral treatment.
This was an isolated case involving a patient who was already very ill, the institute said, and the resistant strain did not appear to be spreading.

South Korea reports first Tamiflu-resistant flu case

2009-11-30T00:35:00.000-08:00

Health authorities on Monday reported South Korea’s first case of swine flu that was resistant to the anti-viral drug Tamiflu, and called for extra precautions against any future cases.
The health ministry said in a statement that it found a Tamiflu-resistant strain of the (A)H1N1 virus in a five-year-old boy, who needed repeated and doubled doses of Tamiflu to recover.
Another anti-viral drug, Relenza, proved effective in specimens taken from the child but he was too young to take the drug, it added.
The ministry urged people to report immediately to hospitals or health authorities if Tamiflu had no effect five straight days after the first dose.
It said the World Health Organization has reported 75 Tamiflu-resistant cases globally since the first such case in North America in April.
South Korea’s swine flu death toll has reached 104 but the spread of the disease is waning, according to the ministry.

Facts about Tamiflu

2009-11-29T13:27:00.000-08:00

When the WHO declared H1N1 virus (swine flu ) as a pandemic, Tamiflu became the most known drug. A lot of rumors have arisen regarding Tamiflu ranging from its administration to its side effects.
So what are the facts about Tamiflu ?
Actually Tamiflu contains the active ingredient Oseltamivir which is an antiviral used for treating and preventing the “flu”, it treats any kind of flu and not specifically swine flu. It should be clear that all antivirals are not a cure for swine flu, but will help to reduce the length of time of illness by around one day, relieve some of the symptoms, and reduce the potential for serious complications such as pneumonia
Mechanism of action of Oseltamivir is suppression and decreasing the spread of influenza A and B viruses. It does this by blocking the action of neuraminidase, an enzyme produced by the viruses that enables them to be spread from infected cells to healthy cells. By preventing the spread of virus from cell to cell, the symptoms and duration of influenza infection are reduced.
On average, oseltamivir reduces the duration of symptoms by one and a half days if treatment is started within forty-eight hours of the beginning of symptoms. A huge advantage of Oseltamivir is that it was FDA approved in October 1999 as an antiviral medication.
But it also should be mentioned that Tamiflu is not a substitute for the flu shot; vaccination is still the first line of defense for flu protection. However, as it is known flu strains vary from area to area, so if you are exposed to a strain of the flu that is not the same strain as the one your vaccination protects against, you may still get the flu — and that’s where Tamiflu may be able to help. This means that Tamiflu can be used within 48 hours after the appearance of the symptoms and should not be taken as a prophylactic medication.
Although Tamiflu seems essential nowadays a lot of people are afraid of using it due to its side effects, of course not everyone taking the medication will suffer from side effects. Usually side effect are nausea, vomiting, diarrhea, bronchitis, abdominal pain, headache and dizziness. These side effects mainly occur due to oral administration of the medication and can be significantly reduced by taking the tablets after meals.
Unfortunately more serious side effects have occurred and they should be reported immediately, for example rare but serious skin reactions and allergic reactions have been reported. Some People, particularly children and adolescents, may be at an increased risk of self injury, confusion, seizures, panic attacks, delusions, delirium, depression, loss of consciousness, and even suicide shortly (24-48 hr) after taking Tamiflu. If any of these side effects appear Tamiflu should be stopped and a physician contacted immediately.
A lot of the schools are taking leaves due to the widespread of swine flu through them, so a lot of parents asking what should I do if my child got sick?!!! Should my child take antiviral medication or not??!!!!!
Although Tamiflu is supposed to be safe for children under 12 .The drugs were found to reduce the duration of the flu by a day, yet not to reduce the complications of the flu such as fewer asthma problems in children with existing asthma or the need to use antibiotics to treat secondary ear infections arising as part of the flu illness process. On the other hand, 1 in 20 children develop nausea and vomiting from these drugs which can cause life-threatening dehydration in any child.
It also should be pointed out that the FDA added a warning label to Tamiflu back in November of 2006, based on numerous reports of delirium and suicide in children. The FDA warning states “People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior”
This data suggests that the benefit to risk ratio should be properly assessed in children on the basis of individual cases and according to the severity of the flu case.
A disturbing revelation nowadays is that the swine flu virus is becoming resistant to Tamiflu which is the most effective antiviral drugs for treatment. Flu viruses normally swap genes as part of their normal evolution; that means resistant viruses could quickly spread worldwide. But it is comforting that pandemic (Swine) flu is still largely vulnerable to the drug, unlike many seasonal flu viruses, which are now broadly resistant and more difficult to treat.
Studies inform us that as of November 2009, only 52 out of over 10,000 samples of 2009 swine flu tested worldwide have shown resistance to oseltamivir and World Health Organization (WHO) reported 57 cases of Tamiflu-resistant swine flu virus and additional cases are being investigated in the U.S. and U.K.
But regarding the seasonal flu, Tamiflu is not very effective in the 2008 seasonal H1N1 virus anymore due to acquired resistance in 99.6% of all 2008 seasonal H1N1 strains, up from 12% in 2007-2008 flu season, as declared by the CDC.
Finally we have to say that most people infected with flu virus will get well with rest and fluids. A hard-to-treat virus can be deadly for some patients, such as pregnant women or children with asthma or cerebral palsy, generally speaking patients who have weak immunity; these patients will need an effective treatment.
However the hopes are still high that Tamiflu will continue to be effective against the pandemic swine flu virus to prevent a worldwide disaster of further spread of the virus.

Reported in 7 Countries Including the U.S

2009-11-29T10:09:00.000-08:00

H1N1 strain has mutated yet again. However, the W.H.O. (World Health H1N1 Swine Flu Mutations Reported in 7 Countries Including the U.S Organization) says that it is nothing to be concerned about. They report that infections were seen in very fewpeople. However, I think that there is something to be concerned about.
The W.H.O. also says that people with normal uncompromised immune systems, will not allow the spread of the mutated virus as easily. Dr. Keiji Fukuda, chief flu adviser of the W.H.O.'s director general, said that the change in the virus did however cause resistance to the medicine used to fight it, Tamiflu. Reassuringly, Dr. Fukuda stated, "We don't know the full answer, but it is more likely that we are not seeing a major shift."
Dr. Fukuda also said that flu's mutate so fast, that it is difficult to keep up with how widespread they are, and their severity. He also stated that W.H.O. scientists are unsure of the threat posed by another mutation that would allow the virus to reach the lungs easier. This mutation has been discovered in various countries including; Ukraine, Norway, China, Japan, Mexico, Brazil, and the United States, in diverse stages of severity. This is why I think we should be concerned. The swine flu strain began as a mutation of the seasonal flu, this mutation led to what is now the modern day pandemic. I believe that scientists should be investigating these mutations more seriously.
The earliest detection of the mutation is from April 2009. Many of the cases that were found in the above countries were fatal; however, many were also mild, therefore, it is correct to say that the mutations are similar to most other mutations in that all cases vary in severity, just like the original H1N1 swine flu, which also is a mutation of influenza. Flu travels inter-species very easily, and can mutate to be very resistant to anything we throw at it, whether it is vaccines or antivirals.

Local pharmacists fight scarcity by mixing Tamiflu

2009-11-29T03:42:00.000-08:00

Some Indiana pharmacists are using a couple of the tools apothecaries used centuries ago - the common mortar and pestle - to bring some relief to children suffering the symptoms of H1N1 and the more common seasonal flu.Health officials have been warning that the Americans most at risk from swine flu are the youngest ones, children from 6 months to 24 months old. The flu danger has been complicated for weeks by a national scarcity of prescription liquid Tamiflu, favored by many doctors for patients too young to swallow capsules.
At right, Jim Kodman compounds a batch of liquid Tamiflu at Gatti Compounding Pharmacy in Indiana
Tamiflu is often prescribed to reduce the severity and duration of a flu infection. To get the most out of the medicine, patients need to take it as soon as possible after flu symptoms appear.
According to Jim Kodman, an Indiana pharmacist and owner of Gatti Compounding Pharmacy in Indiana, Tamiflu was never a blockbuster drug until this fall. But it's been in demand this autumn with the presence of swine flu and seasonal flu simultaneously.
Compounding is a process in which a physician and pharmacist work together to develop customized medications for one particular patient, frequently using raw ingredients in the pharmacy.
"The idea of compounding is to meet one individual patient's needs,'' often based on the patient's weight, Kodman said. Compounding usually becomes more common when large medicine manufacturing companies can't meet the demand. And the unsatisfied demand now is for liquid Tamiflu.
"There is no supply of the liquid. That's a national problem,'' Kodman said.
What Kodman and other compounding pharmacists are doing is using Tamiflu capsules, which are readily available, to make a liquid version of the medicine that is easier for small children to swallow.
"It's one of the simpler compounds to make,'' but it takes time, Kodman said.
The compounding pharmacist must open the capsule by hand, pour the powdered medicine into a mortar and grind it with a pestle. The pharmacist then blends the medicine with a syrup and the resulting mixture has a viscosity between water and the syrup that tops an ice cream sundae. A flavoring is also added to make the medicine more palatable to children.
A critical aspect of compounding is knowing how much of the medicine to use.
Tamiflu capsules are manufactured in the 75-mg size, but young children typically need only 30 to 60 mg, depending on their body weight, Kodman said.
"Usually a fraction of the capsule is used,'' he said.
One Web site suggests that parents can crush Tamiflu capsules themselves and mix the medicine with chocolate syrup for their children.
Kodman said he would not recommend that to a parent.
"The last thing you'd want to do is give your child the wrong dose,'' he said.
Most of the prescriptions Kodman has been receiving for compounding liquid Tamiflu are coming from emergency room physicians at Indiana Regional Medical Center.
Adam Kochman, director of pharmacy at IRMC, said the hospital's own compounding pharmacists have been following the recommendations of the Centers for Disease Control and Prevention to make the hospital's liquid form of Tamiflu.
The IRMC pharmacists compound the first dose of liquid Tamiflu for an ill patient to take even before he or she leaves the emergency room, and a prescription is sent out to one of the local retail pharmacies for more doses the patient can take at home, Kochman said.
Vicky Coark, pharmacy manager at the Giant Eagle Pharmacy in Indiana, said her staff has been compounding a few prescriptions each week for Tamiflu liquid, mainly from physicians in the Indiana area.
She said she hasn't received any news about when commercially manufactured Tamiflu liquid will be available again.
And Robert Kasisky, a pharmacist and owner of the Eaglescripts pharmacy in Indiana, also stands ready to compound liquid Tamiflu if needed.
From his vantage point, Kasisky believes the number of local flu cases may have peaked about one month ago.
But based on his observations as a pharmacist for 17 years, he said, "I don't think we're out of the woods yet.''
He anticipates another spike in local flu cases in mid-winter.

Over 1,000 deaths in a week, main increase in Americas

2009-11-28T11:16:00.000-08:00

The swine flu epidemic death toll is now officially at 7,826, according to the World Health Organization. Mutated and resistant strains are playing a yet-undefined role in the death toll. Around 1,200 mutated strains have been identified.
Europe recorded 300 deaths in the previous week. Most fatalities were in the Americas, where 554 deaths were recorded over that period, up to 5360 up from 4806. That figure indicates deaths from infections of all forms, and represents over 10% of the whole in the time frame.
WHO is monitoring the mutated strains of the virus but is unable at this stage to identify a definite trend in terms of progression. The nature of flu strains is that while some may become killers, many actually mutate into harmless forms.
There’s a problem with predicting mutation characteristics and their effect on viral populations. In a recent case, a mutant form of virus completely replaced the previous strain. In this case a Tamiflu resistant strain became the primary strain.
Epidemic time frames are another problem. A recent flu outbreak in Mexico created a panic, but was relatively brief, and the reporting of the epidemic left a lot to be desired. The moral is that the first case scenarios tend to produce more rumors than facts.
Basic flu, the common version, is believed responsible for 36,000 deaths in the US every year. Swine Flu isn’t yet in that league, globally. The high mutability of this disease isn’t good news, but if it follows the normal pattern of mutation, only a few strains will be dangerous.
Avian flu was a case in point in terms of assessing the relative dangers of mutation. Only one of several strains was identified as a high probability killer, although all strains were lethal in several cases.
So the educated approach is “Don’t get too concerned… yet.”
The ultra-pandemic scenario to worry about it is a “plague” syndrome with high degrees of human to human transmission and lethality. That isn’t the case at this stage. For a communicable disease with an extremely high level of infections, the death rate for Swine Flu is if anything statistically very low.
The spike in deaths may represent a seasonal peak in terms of normal epidemiological assessment methodologies.

Tamiflu shortages for kids give birth to doses with ice cream

2009-11-28T07:41:00.000-08:00

Doctors and pharmacists are racking their brains to work out creative formulas to cope with shortages of Tamiflu influenza treatment for small children who have been principally hit by the ragin H1N1 flu epidemic, with some coming up with doses of adult formula mixed with ice cream.
Tamiflu is administered typically in sweetened dry syrup for small children and in capsules for adults, which are deemed too bitter for small children.
For this flu season, Chugai Pharmaceutical (OOTC:CHGCY) Co., the sole manufacturer and marketer of Tamiflu in Japan, has planned to produce enough of the antiviral drug for 12 million people, around three times more than last season. It includes the dry syrup formula for around 3.6 million, which Chugai started making in September.
According to the Ministry of Health, Labor and Welfare, about 80 percent of flu patients in Japan are underage children chiefly comprising students in primary and lower secondary schools.
In that age bracket, patients have been increasing particularly among those aged 7 or younger, resulting in demand for the Tamiflu dry syrup far outstripping projected supply.
A Chugai spokesman said, ''Since the beginning of November, we haven't been able to catch up in supply. We're producing at full capacity and aren't in a position to boost supply any further.''
Against this backdrop, the health ministry issued information to clinics and hospitals in early November, telling them they ''may re-administer Tamiflu removed from capsules for pediatric formulas and quantities in the event there are no other alternatives.''
Because of its bitter taste, doctors and pharmacists are suggesting doses mixed with ice cream or yogurt, for instance.
Kazutaka Hosoda, a doctor at Navitas Clinic in Tachikawa on the outskirts of Tokyo, points to potential problems with re-administering the adult version for children, saying, ''Redoing preparations takes time and some children may not be able to consume the treatment because it may be too bitter.''
If a child stops taking the drug because of such problems, there may be a risk that the flu virus develops resistance to it, he added.
Hosoda said there are effective drugs other than Tamiflu and he prescribes Chinese medicines.

The doctor's prescription for swine flu: Get a grip

2009-11-27T14:15:00.000-08:00

A barrage of media coverage — photographs of people wearing face masks and stories about terrified officials closing schools.
How to avoid it? How many will it kill?
Are we all going to die?
Remove the letters “d,” “e” and “m” from the word “pandemic” and you get America’s response to swine flu. But are the school closings, canceled travel plans and frantic calls to doctors worthy of the threat?
Incredibly, with a fact-gathering tool as powerful as the Internet, people still react without thinking to the hyperbole of a public official and a scary headline on the 5:30 news. In doing so they create problems disproportionate to the hazard and actually impair the official response.
Regarding swine flu, the doctor’s orders would seem to be: Take a deep breath (face masks optional) because a check of the facts reveals swine flu will be no worse than the barnyard varieties of flu we deal with on a regular basis.
But there’s that menacing word: “pandemic.” It sounds so much like “epidemic,” doesn’t it? What most people don’t know is the word “pandemic” refers to the coverage area of a contagion, not its severity. The World Health Organization recently elevated swine flu to a category 6, its highest level of coverage, which means the virus has spread to enough countries to be considered a global phenomenon. But that doesn’t mean it will be Shiva, destroyer of worlds.
In its most recent report, the Centers for Disease Control and Prevention estimates as many as 34 million cases of swine flu have been reported in the United States from April through October, resulting in as many as 153,000 hospitalizations and 6,000 deaths (the high estimates).
Those are frightening numbers — until you consider that in a normal, non-pandemic year as many as 36,000 Americans die of the flu.
Let’s put those numbers into context. Suppose you heard that in your county, 10 people died of swine flu. You might be tempted to keep your children home, load up the rifles and sit down to a meal of MREs and a screening of “28 Days Later.” Yet in a normal year as you shopped at Walmart, dodged sniffles at the office and warmed chicken soup for your flu-addled family, 60 people in your county died of ordinary flu.
What would you do? Probably nothing.
Yet parents demanding that little Abercrombie receive the vaccine are besieging doctors’ offices, creating problems of supply, demand and more importantly, the physicians’ ability to respond to legitimate health issues. And the indiscriminate use of anti-virals such as Tamiflu actually poses the risk of breeding a vaccine-resistant strain of the virus.
More significantly, the very latest WHO report indicates the pandemic may have spiked in North America. The CDC reports new cases and hospitalizations have fallen three weeks in a row in November. Has the biological apocalypse passed us by? That possibility has somehow escaped folks.
And while the virulence of swine flu isn’t known right now, it appears, from most reports, that it’s no more potent than ordinary flu.
It’s entirely possible the swine flu virus could mutate and become a deadly killer. But it’s more likely the virus will simply run its course and you will deal with it the way you dealt with SARS, ebola and West Nile … by living your lives as you always have.
Thirty-six thousand killed by regular flu. Six thousand killed by swine flu?
Pandemic or panic?
Don’t panic.

Costa Rica to invest $18 mln to combat second wave of A/H1N1 flu

2009-11-27T13:21:00.000-08:00

Costa Rica announced an investment of 18 million U.S. dollars on Thursday in an effort to fight the second wave of A/H1N1 flu expected to hit the nation in January 2010.
To combat the flu, the country's social security system (CCSS) would purchase 30 X-ray machines, 97 fans, and 18,000 Tamiflu (oseltamivir) treatment dosages for patients who need it.
It would also buy 70 refrigerators to store 300,000 vaccines expected to arrive in the country in the next few days.
CCSS President Eduardo Doryan also said that some 227 new jobs would be created as the country was to strengthen patient supervision and improve patient care for the flu pandemic.
So far this year, Costa Rica has reported 40 deaths due to the A/H1N1 influenza.

Medical personnel report giving many regular and swine flu shots

2009-11-27T12:17:00.000-08:00

Local physicians and clinics report administering varying amounts of flu immunizations and many are still receiving doses of the H1N1 vaccination.
Amiee Fulk, public relations coordinator for Banner Churchill Community Hospital, said the hospital staff have given out approximately 850 regular flu immunizations and 100 H1N1 immunizations, specifically to health care providers and first responders. She said fewer than 50 doses of Tamiflu have been given out to patients.
The Churchill County community health nurse gave out 421 H1N1 immunizations, said Ben Kieckhefer, public information officer for the Nevada Department of Human Health Services.
Dr. Lana Narag of the Narag Fallon Family Clinic said her clinic has administered approximately 300 regular flu immunizations and 345 H1N1 immunizations. Narag said she wasn't sure how much Tamiflu has been given out, but it was a lot.
Walgreens spokesman Robert Elfinger said the local Fallon Walgreens received 200 H1N1 doses to administer, and nationwide, the drugstore chain has given out over 5 million regular flu immunizations and offers liquid Tamiflu. Elfinger said a new shipment of H1N1 vaccine will be administered beginning Friday.
Spokesmen for these locations said no one has reported adverse reactions to the H1N1 vaccine.

H1N1 vaccine considered 'safe' by U.S. health officials and WHO states Tamiflu is still effective

2009-11-27T12:11:00.000-08:00

Following the latest news this week that the World Health Organization (WHO) had received reports from both the U.K. and the the U.S. on H1N1 swine flu mutations and resistance to drugs, WHO has stated that Tamiflu should still be used in the majority of cases for H1N1 swine flu treatment. In addition, although the recent H1N1 vaccine recall in Canada may make people reconsider having the H1N1 vaccine, U.S. officials have stated that the H1N1 vaccine is still 'safe'.
Using Tamiflu to treat H1N1 swine flu
Tamiflu proved ineffective in treating H1N1 swine flu in cases in both the U.S. and the U.K. but these incidences were with people who all had a “compromised immune system”. WHO officials have now stated that Tamiflu was still an effective drug in treating H1N1 swine flu in “the majority of cases”.
The safety of the H1N1 vaccine
News on the recall of a batch of H1N1 vaccines in Canada earlier in the week may have prompted fears over the safety of the H1N1 vaccine in the U.S. However, U.S. health officials have reported that the H1N1 vaccine is 'safe', and where side effects have been reported, the majority have been 'minor'. Many pregnant women however are still concerned over reported miscarriages and the effect of the ingredient thirmerosal in H1N1 vaccines.

WHO says Tamiflu still works against swine flu

2009-11-26T11:10:00.000-08:00

The World Health Organization says isolated cases of drug-resistant swine flu in Britain and the United States have not changed the agency's assessment of the disease.
It says Tamiflu remains highly effective against the vast majority of H1N1 cases.
Four cancer patients in a North Carolina hospital tested positive last week for a type of the flu that was resistant to Tamiflu. Five people at a British hospital also didn't respond to the drug after contracting the flu.
WHO flu chief Dr. Keiji Fukuda said Thursday that investigations were under way, but that the American and British patients for whom Tamiflu did not work had severely weakened immune systems.

Tamiflu still fights H1N1 despite resistant cases

2009-11-26T10:47:00.000-08:00

The isolated cases of Tamiflu-resistance in swine flu patients in Britain and the United States likely aren't a sign that the virus is becoming resistant to the antiviral drug, a WHO spokesperson said Thursday.
The UN health agency has not changed its assessment of the disease, WHO flu chief Dr. Keiji Fukuda told reporters.
Clusters of resistance have been discovered at hospitals in Wales and North Carolina and need to be investigated further, he said.
The cases occurred in severely immunocompromised patients, who are at risk of developing drug resistance.
What health officials are on the lookout for are signs that resistant strains of virus are moving from patients to infect those with healthy immune systems, and there is no reason to suggest that has happened, Fukuda said.
"What it points out is there needs to be a lot of vigilance taken with those groups of patients, but it probably does not have big implications for the overall pattern of spread or the overall patterns of illness in the general community," he said from Geneva during the WHO's weekly briefing on the swine flu pandemic.
So far, 75 cases of Tamiflu resistance related to the H1N1 influenza A virus that causes swine flu have been reported to WHO.
On Wednesday, public health officials reported one more patient has tested positive for H1N1 virus resistant to Tamiflu at a hospital in Cardiff, raising the total number of cases in that hospital to six.
It was not unexpected that more patients exposed to the original case would test positive for the resistant strain, said Dr. Roland Salmon, director of the National Public Health Service Communicable Disease Surveillance Centre in Cardiff.
"The emergence of influenza A viruses that are resistant to Tamiflu is not unexpected in patients with serious underlying conditions and suppressed immune systems, who still test positive for the virus despite treatment," Salmon said in a release.
"In this case, the resistant strain of swine flu does not appear to be any more severe than the swine flu virus that has been circulating since April."
Mutation in Norway
Last week in North Carolina, four cancer patients tested positive for a type of flu virus that was resistant to Tamiflu.
More investigation will also be needed into a mutation reported by health authorities in Norway to clarify whether the mutated virus is more likely to trigger severe illness or become more common.
"And the question is whether this mutation … suggests that there is a fundamental change going on in viruses out there or whether there is a turn for the worst in terms of the severity? And I think the answer right now is that we are not sure."
Fukuda also commented on Canada's vaccine surveillance system, which picked up a potential problem in one lot of H1N1 vaccine that was halted from further use. Before then, six people who were vaccinated from the batch developed anaphylaxis, or severe allergic reaction.
On Wednesday, the Public Health Agency of Canada confirmed 24 cases of anaphylaxis among people who have received the H1N1 vaccine.
Flu activity appears to be leveling off in some areas of the northern hemisphere, but Fukuda cautioned against saying activity has peaked until there is a definitive downward turn.

Police raid drug importers for illegally marketing antiviral meds

2009-11-26T01:23:00.001-08:00

Police raided the offices of five pharmaceutical importers on Wednesday for illegally advertising the anti-influenza drug Tamiflu online.
Osaka Prefectural Police searched the five drug importers after they advertised the anti-flu drug without government authorization -- a violation of the Pharmaceutical Affairs Law.
It was the first time police have carried out raids in the investigation of the illegal trade of anti-influenza virus medication, which is becoming increasingly common as swine flu spreads rapidly throughout Japan.
Currently, the Ministry of Health, Labor and Welfare restricts sales of Tamiflu to its official Japanese distributor Chugai Pharmaceutical Co., and the advertisement or sale of the drug by other dealers is prohibited by the pharmaceutical law.
Investigators have searched a total of 12 locations in six prefectures, including the branch offices of one Osaka-based company, three Tokyo firms and one individual importer in Okayama.
Police allege the five distributors advertised the product by uploading photographs of Tamiflu 75mg packages to their Web site, in an apparent attempt to sell them for between 8,200 and 16,000 yen per 10 capsules, while claiming to be personal trade facilitators providing import management services.
Police will investigate whether the importers have already sold unapproved anti-flu drugs to customers.

State Asks Pharmacies To Give Free Flu Meds

2009-11-26T01:15:00.000-08:00

The state has sent letters asking pharmacies to give the medicine free of charge to those who can't pay.
"We're seeing an outbreak," said pharmacist Phillip Bradley of Bradley Drug Co., who said he's seeing a lot of patients with the flu, both H1N1 and seasonal, but not all of his patients are getting help.
"We're seeing a lot of prescriptions coming through here that are antivirals, but I know that a lot of my customers that are uninsured, I don't see them coming in with prescriptions," said Bradley.
The government sees the problem, too, which is why the state just sent letters to all the pharmacists in Tennessee asking them to dispense antiviral medications -- normally Tamiflu -- to uninsured and under-insured Tennesseans who can't afford it for free.
The pharmacies themselves have to sign up for the program, but Bradley said he thinks it's a good idea
"My initial thought is it's a great thing for Tennesseans," he said. "A lot of the uninsured do not have the ability to get antiviral medications because of the expense, so through the state and through the pharmacy association, we're going to be able to dispense these antiviral medications at no charge."
Tamiflu costs about $100 if it's paid for out of your pocket.
In an unprecedented move, the state will dispense the medicine to the pharmacies from a state stockpile to help prevent the spread of H1N1and perhaps counter the fact that it's been difficult keeping up with vaccination demand.
"We'll be able to hopefully help limit the antiviral activity in this community," said Bradley.
Doctors will let pharmacists know which patients can't afford the antiviral medicine by writing "TDH stockpile" on the prescriptions.
Pharmacies are still in the process of signing up with the state, so you will need to check with your doctor and pharmacy before you can get the free medicine.

WHO probing drug resistant swine flu

2009-11-25T15:05:00.000-08:00

The World Health Organization is looking into reports in Britain and the United States that the H1N1 flu may have developed resistance to Tamiflu in people with severely suppressed immune systems, a spokesman said Tuesday.
Britain's Health Protection Agency (HPA) said five cases have been confirmed in Wales of patients infected with H1N1 resistant to oseltamivir -- the generic name of Roche and Gilead Sciences Inc's antiviral drug Tamiflu.
The patients had serious conditions that suppressed their immune systems, which can give the virus a better than usual opportunity to develop resistance, the HPA said. It said the drug-resistant strain had probably spread person to person.
"We have seen the reports, we need to look into them," WHO spokesman Thomas Abraham said in Geneva.
The U.S. Centers for Disease Control and Prevention last week also reported four cases of H1N1 resistant to Tamiflu at Duke University Hospital in North Carolina. All were said to be very ill with underlying severely compromised immune systems and multiple other complex medical conditions.

The WHO spokesman said both the reports involved Tamiflu resistance in people with severely compromised immune systems.
"We'll see if we need to put any additional measures in place to protect this vulnerable group of patients. It might mean that they are at more serious risk than others," Abraham said.
People with suppressed immune systems, such as those undergoing chemotherapy or suffering from HIV are more likely to fall ill from infections.
The WHO has previously reported cases of the pandemic virus being resistant to oseltamivir but says these are rare.

Roche CEO sees group outpacing market in 2009-paper

2009-11-25T11:04:00.000-08:00

Swiss drugmaker Roche's (ROG.VX) pharma and diagnostics units will significantly outpace the market this year, the group's head was quoted as saying in an interview on Wednesday.
Roche is also confident it will reach its recently raised sales growth target for its pharma division of at least high-single digit growth, chief executive Severin Schwan told Swiss weekly Handelszeitung in an interview.
Schwan said he was confident the pharma unit would gain market share thanks to its strong drugs pipeline, adding the group would announce 2010 targets for the unit at the start of next year.
Roche, the world's biggest maker of cancer drugs, posted a forecast-beating 10 percent rise in third-quarter sales last month, helped by demand for Tamiflu due to the H1N1 swine flu pandemic. [ID:nLD628052]
Schwan said the group's pharma unit was still growing faster than the market, even when excluding Tamiflu sales -- likely to be above 2.7 billion Swiss francs ($2.67 billion) this year -- and Roche's key cancer drugs were seeing double-digit growth.
Schwan said Avastin, which had annual global sales of 5.2 billion Swiss francs in 2008, still had considerable potential, with over 450 trials running on more than 30 different cancer types.
Separately on Wednesday, Roche said it had filed for European approval to extend the use of Avastin to patients with metastatic breast cancer in combination with a broader range of standard chemotherapies.[ID:nGEE5AO05D]
Roche sealed a $47 billion buyout of U.S. partner Genentech earlier this year. Schwan said the group was now looking for small and mid-sized acquisitions.
The group repaid 7 billion francs of debt from the Genentech buyout in the third quarter and Schwan said the group would be able to get rid of 25 percent of its debt next year and have a positive net-cash position by 2015.
Schwan said Roche was sticking to its dividend policy despite the Genentech deal. Roche paid a dividend of 5 francs this year.
Roche stock was trading up 0.24 percent at 167.80 Swiss francs, slightly underperforming a 0.6 percent rise in the European pharmaceuticals sector .

H1N1 is now a full blown mutated pandemic in many countries

2009-11-25T09:56:00.000-08:00

If you thought the H1N1 story was history then you might be mistaken. Reports from the CDC, the WHO and doctors confirm that the "plague" that was and still is in the Ukraine now spread to cities all over the world where the lungs of people fill with blood, their lungs get destroyed within days and then they die.
In the Ukraine currently we see people getting infected, going to hospitals but not coming out again. They remain sick for longer than usual, we also hear of a lot of people where they die and their lungs are filled with blood.
According to the WHO they said earlier this month that the H1N1 in Ukraine was the same as in other countries but afterwards they said it did in fact mutate. In Norway the disease or whatever we may call it mutated as well according to the WHO that said also earlier this month that:
The Norwegian Institute of Public Health has informed WHO of a mutation detected in three H1N1 viruses. The viruses were isolated from the first two fatal cases of pandemic influenza in the country and one patient with severe illness.
Norwegian scientists have analysed samples from more than 70 patients with clinical illness and no further instances of this mutation have been detected. This finding suggests that the mutation is not widespread in the country.
The virus with this mutation remains sensitive to the antiviral drugs, oseltamivir and zanamivir, and studies show that currently available pandemic vaccines confer protection.
Worldwide, laboratory monitoring of influenza viruses has detected a similar mutation in viruses from several other countries, with the earliest detection occurring in April. In addition to Norway, the mutation has been observed in Brazil, China, Japan, Mexico, Ukraine, and the US.
So that means that the h1n1 has mutated in all the above countries according to the World Health Organization.

Analysing Tamiflu on the Fortis C18 column

2009-11-25T01:02:00.000-08:00

Fortis Technologies has published an application note showing the successful analysis of Tamiflu (oseltamivir) on its silica-based Fortis C18 column.
The official method approved by the Centre for Disease Control and Prevention (CDC) shows that the best option for the analysis of oseltamivir is by using high-pH mobile phase to neutralise the analyte.
A Fortis C18 column is used in this application due to its ability to work with high-pH mobile phase systems.
Based upon a silica particle template, the bonding process of Fortis C18 allows the full use of the pH range from 1-12 without the need for a hybrid technology.
Being able to operate on a silica particle means no loss of efficiency, loadability or speed of equilibration.
Scalability and ease of method transfer from UHPLC through to preparative chromatography is maintained in the simplest of fashions.

Egypt to make own Tamiflu

2009-11-25T00:47:00.000-08:00

Health Minister Hatem el-Gabali said on Tuesday that Egypt will produce the Tamiflu vaccine for both Avian and Swine flu patients, locally, at 75 Egyptian pounds ($14) per packet, explaining that it will import raw materials from different bodies accredited by the World Health Organization. The minister confirmed that the price of the virus testing in Private labs in the country would cost some 800 Egyptian pounds ($145).
Gabali stated during the fourth session of the 6th development of health services conference in Sharm El Sheikh that “strategic stockpiles of Tamiflu available in the ministry , are enough,” pointing out that the epidemic situation of the disease is “stable and the death rate did not exceed three per one thousand, less than a quarter of the death rate in countries the world.”
He also confirmed that the ministry continues to conduct the virus tests for free to selected groups of citizens in need, stressing that “not all the labs are equipped to conduct such tests, especially the provision of reagents used to make the testing possible,” explaining that allowing private labs the ability to make these tests does not mean that the ministry will give up conducting such examinations.
He stressed that the ministry will give the infected Tamiflu for free within and outside the hospitals run by the ministry, meaning that some people will be given Tamiflu without being held in hospital. It is part of the ministry’s efforts to help create a means to treat as many individuals as possible.
The ministry warned laboratories against the public declaration of the results of the tests they give, noting the need to inform the ministry of positive results before going public and to “be approved by a consultant physician or specialist who holds a doctorate degree” from the ministry.
Egypt has seen more than 3,000 H1N1, or Swine flu, cases since it was first discovered in the country last June. At least 10 people have died from the disease, but the ministry says its efforts to curtail the spread of the virus are “having results.” The Avian flu, or bird flu, has been more detrimental to Egypt, with dozens of people dying from the deadly virus since it first arrived in the country in early 2006.
Egypt is a major gateway for air-born diseases as it lies on the cusp of three continents and is a major migratory stop for birds. The ministry, and global health officials, fear a mutated form of Avian and H1N1 into a virus that could ravage the population.

Tamiflu-Resistant H1N1 Flu Strain Shows Up

2009-11-24T12:30:00.000-08:00

Could there be a new strain of H1N1? That's what health officials are investigating after several cases seem to be resistant to the treatment drug Tamiflu.
Four patients at Duke University Medical Centers in North Carolina and five in Wales have been diagnosed with a strain of flu too strong for Tamiflu to treat.
Health officials with the U.S. Centers for Disease COntrol and Prevention say this doesn't indicate a health emergency. But there is concern over what appears to be mutations of the virus.
"We are unable to say if their deaths were caused by influenza, they are influenza associated but they had medical issues that were compromising their health," said Megan Davies, a North Carolina state epidemiologist.
The virus is just as severe, but this new mutation of H1N1 has a different characteristic. It might not be treatable with medications currently available.
"This resistance is from a mutation but its doesn't mean H1N1 in general is mutating. It's a mutation that has occurred in a small number of patients," said Dr. Zack Moore, a medical epidemiologist.
Health officials with CDC are investigating the connection - if any - between the Duke and Wales patients.
Doctors at Duke were still treating one patient who appeared to have the mutated H1N1 strain with the drug Relenza. She appeared to be recovering.
"The vast majority of people with influenza do not even receive antivirus treatment. This mutation is a moot point to most of us. However, it's something we have to pay attention to when we see it," said Davies.
Dr. Frank Esper with Rainbow Babies Children's Hospital at University Hospital said over 1,000 H1N1 cases were screened at the hospital for resistance and only 10 were Tamiflu-resistant.
So, Tamiflu is still able to treat the vast majority of H1N1 flu cases. Esper says flu viruses are constantly changing so there was no surprise the H1N1 strain mutated to survive.
Vaccination against H1N1 still appears to be effective.

Swine flu - is a Misinformation?

2009-11-24T11:00:00.000-08:00

As one of the two MedPage Today writers on full-time H1N1 duty since the beginning of the outbreak in April, I feel like I know the issues well enough to help clear up misconceptions when they come up in conversation.
The other day, just such a situation presented itself. An acquaintance of mine, who is pregnant, said she was very concerned about H1N1 because "pregnant women can't fight it off."
Although pregnant women have a tougher time fighting off infection from H1N1 and other pathogens, it's certainly not a lost cause. But I let that one go.
This acquaintance's fear was heightened, however, by something she had heard -- that pregnant women who come down with H1N1 flu can't be treated the same way as non-pregnant people because the drugs used to battle the virus will kill the baby. Not might kill the baby. Will kill the baby.
I was shocked when I heard this because presumably she was talking about antivirals, for which pregnancy is not a contraindication.
I was also surprised because this is not a myth surrounding the H1N1 pandemic that I'd heard before.
For the record, oseltamivir (Tamiflu) and zanamivir (Relenza) are "Pregnancy Category C" drugs, which means there haven't been any clinical studies evaluating the safety of these medications for pregnant women.
But they've been used for seasonal flu and according to the CDC, "the available risk-benefit data indicate pregnant women with suspected or confirmed influenza should receive prompt antiviral therapy."
For treatment of pregnant women, the CDC recommends oseltamivir as the drug of choice because of its systemic activity.
The agency is less clear regarding chemoprophylaxis: "Zanamivir may be preferable because of its limited systemic absorption; however, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems."
I explained to my acquaintance that the CDC recommends antiviral treatment for pregnant women and that there was no evidence that the drugs were killing fetuses.
I hope, in the event that she does develop flu-like symptoms, that she won't hesitate to seek treatment.
The exchange made me wonder, though: What other misconceptions about H1N1 and the vaccine are floating around out there?

Stockpiling Tamiflu Is Not A Healthy Habit

2009-11-24T10:52:00.000-08:00

Research shows H1N1 flu activity is down across the city and the country, but that is not stopping some people from stocking up on the most popular anti-viral treatment. NY1's Health reporter Kafi Drexel filed the following report.
For months, the children's version of Tamiflu, or the liquid form of the anti-viral drug, has been in limited supply across the country.
There's still plenty of supply in the city, but with the Swiss drugmaker Roche not expected to make more available in the United States before January, pharmacists like Charles Tabouchirani of Cherry Pharmacy in Manhattan's Upper East Side have been busy converting the adult capsule form to pediatric doses.
"We are seeing more prescriptions for Tamiflu and the initial reaction from a parent, because we are a pediatric pharmacy, is panic when they know the Tamiflu suspension is not available," says Tabouchirani. "But of course we can make it, we can compound it. It's as effective and actually tastes a little better than the manufactured Tamiflu."
While there hasn't been as much flu activity in New York City as there was this spring, health officials say pharmacists are reporting an increase in Tamiflu prescriptions particularly for young children ages zero to four. And they say that activity is out of proportion with the amount of illness currently circulating around the city.
"It is really about people nervous and stockpiling, which is a bad idea for a couple reasons," says Dr. Don Weiss of the city's Department of Health. "One, you put it in your cupboard, you forget about it. Then maybe you need it, it's already expired. Two, although we don't have a shortage of Tamiflu now, if people continue to stockpile, then maybe there will be a shortage and it won't be available to people who really need it."
Cases of a Tamiflu-resistant strain of the virus have been reported in Europe in patients with serious underlying medical conditions, and the Centers for Disease Control has already confirmed a resistant strain of H1N1 flu in a small cluster of patients in North Carolina.
While they continue to investigate, health officials say those small pockets of illness, compared to millions of other cases across the globe, do not mean a sudden shift towards a more dangerous strain of the virus. Another antiviral treatment, Relenza, has still worked in some of those patients.
There's no way of knowing if H1N1 flu activity in New York and across the country will continue to calm down or increase along with seasonal flu in the coming months. So in the meantime, most doctors still say the most important thing people can do is to get vaccinated when they can for both seasonal and H1N1 flu.

Fear of the flu

2009-11-23T23:57:00.000-08:00

For a few moments, Austin Torres was afraid he was going to die.
The night before, Austin found out he had the flu strain known as H1N1, the 11-year-old had a sore throat, headache and fever. His mom, Denise Torres, knew what was wrong but didn’t tell him at first. Austin woke up the next day feeling worse, so Torres took him to the doctor’s office, where tests confirmed he had H1N1.
When Torres told Austin he had H1N1, he immediately became upset and started crying.
“I was kind of scared. I had heard of all those deaths from H1N1,” said Austin of Tarboro.
Austin’s reaction wasn’t a complete surprise for Torres, a physician assistant with the Chronic Heart Failure Clinic at Heritage Hospital. She had seen worse reactions from parents who found out their children had or were suspected of having H1N1. It can be terrifying for parents whose only knowledge of the illness comes from news stories about outbreaks or deaths.
H1N1 needs to be taken seriously, as evidenced by the fact that many people in the United States and abroad have died from it, said Carol Schriber, a spokeswoman for the N.C. Department of Health and Human Services. From April through Sept. 26, when health officials stopped differentiating H1N1 from other influenzas, the state reported 13 deaths and 267 hospitalizations from laboratory-confirmed H1N1.
However, much of the fear surrounding H1N1 stems more from its unpredictability than from it actually being worse than other strains of flu, she said.
Until this year, the flu for many people meant vaccinations in October and the possibility of catching it from November to early spring, Schriber said. Older people usually were the most at risk.
Then H1N1 showed up this spring and hung on through summer, fall and now probably into winter, Schriber said. Instead of older people, children and young adults ages 6 months to 24 years are the most at risk.
“When it is something new, and of course nobody knew how bad H1N1 might get, then it becomes scarier. When it hits different populations than we are used to, then it gets scarier for people,” Schriber said.
In reality, the strains share most of the same symptoms: fever, cough, sore throat, runny nose, body aches, headaches and tiredness, Torres said. Some people with H1N1 also might have diarrhea or vomiting.
In most cases, health care officials are telling people suspected of having H1N1 that the virus will have to run its course, Torres said. It lasts an average of three to five days but can linger for weeks depending on the person and his or her immune system.
Because of shortages and fear of developing a resistance, antiviral drugs such as Tamiflu mainly are reserved for children, pregnant women and people already suffering from other conditions that can lower a body’s defenses, including diabetes, asthma and heart disease, Torres said. Tamiflu stops H1N1 from replicating and often cuts its normal run by two days or lessens the symptoms.
Since Austin has asthma, he was considered in the high-risk group and put on Tamiflu, Torres said.
Paula DeLong, 53, wishes she had been given Tamiflu when her first symptoms showed up Oct. 5. She originally was diagnosed with a bad cold and, later in the week, bronchitis.
“I got worse and worse. In fact, that weekend was the weekend I thought I was going to die. All I could think about was that my heart wasn’t getting enough oxygen and that I was going to have a heart attack,” said DeLong, sales and marketing manager at the Rocky Mount Telegram.
When DeLong’s conditioned worsened and she returned to the doctor Oct. 14, she was told she had severe bronchitis most likely as a result of H1N1. She couldn’t be tested for the virus because the limited number of test kits doctors receive are reserved for higher risk patients. DeLong wasn’t able to return to work for 3 1/2 weeks.
While health officials continue to work on the medication shortage problem, they encourage people in high risk groups to get their H1N1 vaccine and for everyone to continue the good practices of washing their hands regularly, coughing into their sleeves and staying home if they are sick, said Karen Ramsey, health education supervisor at Nash County Health Department.

1918 Flu Pandemic Genes Found in Current Swine Flu

2009-11-23T13:22:00.000-08:00

Recombinomics has stated that a paper published by the National Institute of Health has reported the presence of similar binding receptors in swine flu samples from Brazil, Ukraine and Norway.
Although WHO stated that this change was "not significant" in the Ukraine samples, it was associated with the fatal cases and is cause for concern. The concern was increased by the announcement from Norway indicating the same change was found in fatal H1N1 lung infections there also.
Some have commented that this change was spontaneous and diid not spread, although this change was found in all four deceased patients in Ukraine from two distinct locations -- meaning they did indeed spread. What is serious, though, is what this means for the spread of the pandemic.
The concept of acquisition via recombination has serious implications for the current pandemic. It was used to predict the D225G change, in part because the change was "in play" and appearing in July/August sequences at increasing frequency, even though the H1N1 sequences represented different genetic backgrounds. Similarly the clusters of Tamiflu resistance in Wales and North Carolina are also driven by recombination, as happened when the identical change was acquired in H1N1 seasonal flu in patients who were not taking Tamiflu (oseltamivir).
These changes to the swine flu virus are making it resistant to Tamiflu, the best medicine to fight this kind of viral infection.
Similarly the clusters of Tamiflu resistance in Wales and North Carolina are also driven by recombination, as happened when the identical change was acquired in H1N1 seasonal flu in patients who were not taking Tamiflu (oseltamivir).

Cox Warns Consumers About Tamiflu Drug Prices

2009-11-23T08:30:00.000-08:00

Attorney General Mike Cox today announced the results of an undercover survey that showed significant price variations at pharmacies across the state for the H1N1 drug Tamiflu. Cox’s team of investigators looked into the price of liquid Tamiflu, a form commonly used to treat children, at fifty different pharmacies across five Michigan communities and found that some consumers may be paying more than they need to.
Excluding select pharmacies offering free Tamiflu while their supplies last, the Attorney General discovered that statewide prices ranged from $28.00 at one Lansing pharmacy to $140.00 at a pharmacy in Grand Rapids. Pharmacies in Detroit, Flint, Grand Rapids, Lansing and Traverse City were contacted, and the price range in each community included:
Detroit- $50.00 to $122.00;
Lansing- $28.00 to $119.00;
Grand Rapids- $47.90 to $140.00;
Flint- $48.00 to $94.00; and
Traverse City- $54.90 to $129.99
Cox urges Michigan residents to shop around for the best price on Tamiflu and all their prescription needs. The Attorney General’s office is contacting pharmacies with higher prices to gain more insight into why some have prices that are significantly higher than others.
“The high cost at some pharmacies of a drug that can save lives is disturbing,” said Cox. “These prices show the importance of checking more than one pharmacy, especially residents without insurance.”
Cox also released a consumer alert today, titled “How to Safely Save Money on Prescription Drugs,” including tips to help consumers shop around for the best price on a prescription for Tamiflu and other drugs. The consumer alert, found at www.michigan.gov/tamiflu also warns consumers to stay away from so-called “miracle” H1N1 cures that they may find on the Internet.
Consumers who believe they have been charged an excessive amount for Tamiflu should contact the Attorney General’s Consumer Protection Division at (877) 765-8388. Complaints can also be filed at www.Michigan.gov/ag.
Michigan consumers looking for additional information about the H1N1 or seasonal flu, including tips to help prevent or treat the flu, and examples of fraudulent flu products, are encouraged to visit http://www.flu.gov.

Swine flu type found in North Carolina develops resistance to Tamiflu

2009-11-23T01:36:00.000-08:00

The dreaded swine flu is getting smarter and smarter meaning the medical community has to keep working on ways to battle the strand that has sickened thousands from coast to coast.
Federal health officials confirm that four people in North Carolina have tested positive for a strand of swine flu has developed a resistance to the drug Tamiflu.
This new finding makes the NC cluster the first the U.S. has seen of that many cases so close together.
Health officials say the cases came out of Duke University Medical Center in Durham, North Carolina.
Tamiflu has been touted as one of two of the most effective treatments to fight the swine flu, though health officials are now keeping a closer eye on the warning signs that that virus is beginning to mutate again which would make the drug ineffective.
According to the Associated Press, “About 52 resistant cases have been reported in the world since April, including 15 in the U.S. so far. Officials with the U.S. Centers for Disease Control and Prevention say almost all the U.S. cases have been isolated.”

Wales Tamiflu-resistant swine flu responds to Relenza - One antiviral still works on H1N1 mutatio

2009-11-22T10:11:00.000-08:00

The H1N1 swine flu virus is mutating, causing more severe illness and resistance to antiviral medications. More severe strains of H1N1 mutation have been identified in Norway and the Ukraine. The Norwegian and Ukraine flu outbreaks cause bleeding in the lungs. Tamiflu-resistant swine flu clusters have been found in North Carolina and Wales, while isolated incidents of antiviral-resistant strains of swine flu have been identified all over the world.
Tamiflu-resistant swine flu mutation
The swine flu mutation that results in a resistance to treatment by the antiviral medication Tamiflu has been found in two clusters. Four patients in a North Carolina hospital were diagnosed with the antiviral-resistant strain of H1N1 within a six-week span. Three of the four patients passed away, although it is unknown if the swine flu was the cause of death. In Wales, five patients have been identified as victims of the H1N1 mutation, with an additional three infections undergoing investigation.
Relenza as alternate antiviral treatment
Relenza is an alternate antiviral treatment to the use of Tamiflu in cases of the swine flu mutation. In addition, this antiviral medication is recommended by the manufacturer for the prevention of H1N1 infection. According to a Stanford Study, Tamiflu and Relenza are equally effective in the prevention of flu symptoms in uninfected people, but safety information for children has not been explored.