Severely Ill Patients With H1N1 Do Not Require Higher Tamiflu Doses

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

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

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
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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

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

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

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.

Public Citizen questions effectiveness of Tamiflu

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

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

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

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

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

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

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

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

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!

Asthma Sufferers At High Risk For Future H1N1 Pandemics

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

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

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

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."

Did a Flu Drug Manufacturer Withhold Evidence From Drug Trials?

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.