Scientists Develop Cheaper Version Of Tamiflu

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

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.