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."
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."
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