Tamiflu, the data call inconsistent, does not adequately reflect

January 20, 2012 - The international team of medical experts are calling into question the safety and efficacy of anti-flu drug Tamiflu, oseltamivir article), saying that the review of unpublished data indicates non-compliance and that the drug's manufacturer, Roche, has failed to provide access to a range of information on its content. review was published online January 18, the Cochrane Library.Governments around the world spent billions of dollars stockpiling oseltamivir and zanamivir (Relenza, GlaxoSmithKline) - neuraminidase inhibitor drugs have been recommended by the World Health Organization, 2002. To treat flu pandemic.This class of drugs, data integrity and continues to be debate, however. In a previous Cochrane review published in 2008., Researchers documented a significant concern for publication bias in drug. Importantly, they reported that as much as 60% of patient data from the Phase 3 trials for oseltamivir treatment has never been published.Unpublished data in the study in 1400 people of all ages, is the largest treatment trial ever conducted on oseltamivir."We are concerned that the data remains inaccessible to scrutiny, the scientific community," - said Tom Jefferson, MD, author of the Cochrane review and the previous analysis and analysis of new and independent epidemiologist based in Rome, Italy, in a press statement.This week's update a previous review, Dr. Jefferson and scientists.In the United States, Britain, Japan and Australia have analyzed previously unpublished data from 25 studies, including 15 for oseltamivir and zanamivir for 10. Another 42 studies reviewed, the data can not be due to insufficient information or unresolved discrepancies in the data, the authors note.The data in clinical research reports and regulatory documents that were publicly available sources or through the Freedom of Information or requests. The studies mainly involved adults in both hemispheres flu season. All the studies that were reviewed supports the drugs' makers."We reasoned that the regulatory data can help contextualise the survey data, a deeper insight than just the clinical study reports, the authors write.Symptoms decreased hospitalization but unchangedAbout the oseltamivir studies have shown that the drug reduces the symptoms, how long on average 21 hours [95% confidence interval -29.5 -12.9 hours., P <0.001). However, it failed to reduce the number of people requiring hospitalization odds ratio 0.95, 95% confidence interval, 0.57 to 1.61, p = 0.86).Postprotocol 8 studies the analysis, the authors found that randomly assigned to receive oseltamivir treatment trials, participants had to reduce the chances of being diagnosed with influenza (odds ratio 0.83, 95% confidence interval, 0.73 to 0.94, p = 0.003), which they say that probably altered antibody response. Zanamivir studies showed the same trend.Biased reports of adverse eventsSignificant discrepancies neuraminidase inhibitor side effects while evidence has been observed in previously published and unpublished studies. For example, the Japanese showed a higher normative documents relating to the nervous system and psychiatric adverse events among patients treated with oseltamivir compared with placebo, but there is no published reports of these data for the mention.Two most cited published reports of serious adverse events, no mention of adverse events, and other "stated that" ... there was no drug-related serious adverse events, "the authors note."[W] e did not find a published paper oseltamivir court, who reported neurological or psychiatric adverse events, except for a headache - they write.Adding further speculation oseltamivir published studies is that Roche, the British Medical Journal, when pressed after the previous report, acknowledged that some of the documents published on the drug was ghost written.In a statement to Medscape Medical News, "Roche said that if the Cochrane group to up to 3200 pages of very detailed information to answer their questions. "Roche has made all the clinical trials of health authorities around the world, their views, as the licensing process. It is the world's health authorities in view detailed information on medicines to assess the benefits and risks "the company said.All supporters of Tamiflu by Roche to acquire the safety and efficacy clinical trials as a peer-reviewed journals or in summary form on www.roche-trials.com. Further clinical study reports is to use a password protected site investigators, allowing scientists to examine these studies and publications related to their conclusions."Although the Cochrane authors can challenge whether the information provided to them and answered their questions, it is clear agreement on the role of global health authorities, and suggest that this is where the ball dropped.CDC - however, agrees with OseltamivirDespite the specter of written documents and adverse event reporting discrepancies top government agencies, including the U.S. Centers for Disease Control and Prevention (CDC), further support to oseltamivir, Dr. Jefferson told Medscape Medical News."The U.S. CDC and the CDC continue to quote the tests of Tamiflu which we now know, was written by a ghost," - said Dr.. Jefferson."They keep citing evidence of adverse effects, but they understand our concerns and the fact that 60% of medical research data are not available, and has never been evaluated for Roche and maybe 1 or 2 of the range."Journal of the discrepancy report "absurd"A separate study published online January 17, the British Medical Journal, in line with the Cochrane review shows that oseltamivir were different standards of various regulatory agencies around the world, and even conflicting impressions of the efficacy.The European Medicines Agency (EMEA), for example, if the clinical study reports on research into drug oseltamivir Cochrane part, despite the fact that the agency was legally allowed to ask the manufacturer for all messages.EMA, which announced its intentions to the British Medical Journal published all drugs submitted for approval for the coming financial year.Press release, Fiona Godley, MD, British Medical Journal editor in chief, said the finding emphasizes the need for a more coherent approach to drug regulation in the global community.Discrepancies between the various regulatory authorities around the world underlines the conclusions of the absurd situation we find ourselves in, "- she said."In a globalized world, regulators should work together and pool their limited resources. Otherwise, we continue to waste money and risk to human health due to a drug that does not work."Upcoming flu epidemic accelerated drug approval processDr. Jefferson noted that the most likely threat of a global pandemic and emergency treatment of the newer drugs have played an important role in the review of neuraminidase inhibitors in the fast lane."We have reviewed the documents, a clear reason why it was approved the first drug, a neuraminidase inhibitor family, Relenza, they have not been registered since 1988. New anti-flu drugs," - said dr. Jefferson. "It was now 1999, the impending threat of an influenza pandemic, and they felt that they needed to move along the field and record this new drug."Disturbing not justify the continued support of drugs when important issues are raised, however, suggested Peter Doshi, PhD, of Johns Hopkins University, Baltimore, Maryland, co-author of the review."Government support of the manufacturer's claim in its own independent examination is dangerous," - said Dr.. Doshi."In an emergency, of course the standard of proof may change, but that clinical trials of Tamiflu to more than a decade ago, yet no evidence that the CDC and Health and Human Services Department, which supports a number of statements about the manufacturer, to make their own independent verification of the completed trial evidence .Tim Uyeki, MD, medical epidemiologist at the CDC official and flu Section Medscape Medical News, said the agency could not comment on unpublished data, however, he explained that the CDC guidelines, according to employees under the direction of the immunization practices advisory committee to carefully consider the risks and benefits drugs in their public health needs."The use of antivirals for the treatment of influenza in the U.S. leadership is based on published data, including randomized controlled trials, tracking tests, and consider a high risk of complications from influenza group performance review. There are some inherent limitations of observational studies, taking into account the fact that they are not controlled, but they can be very informative, "- he said."There is abundant observational studies of hospitalized patients with seasonal flu and as of 2009. H1N1 pandemic, and they all show the clinical benefit of antiviral therapy, especially if these drugs to start early."Dr. Uyeki added that the current lack of other anti-flu is indeed an important issue."One has to look at what the benefits and options available evidence," - he said. "We do not have many other options for treatment of influenza now we certainly need more antiviral drugs - drugs, working in a variety of mechanisms of action. And other treatment methods such as combination antiretroviral therapy""Vaccination is the best way to protect against flu, but it will not prevent all diseases from flu."Seasonal influenza epidemics are associated with an approximate average of more than 200,000 hospitalizations annually in the United States of America, and range from approximately 3400 to 49,000 flu-related deaths per year, Dr. Uyeki said.All research must be available regardless of commercial interestsCochrane report, scientists say they support the charity, or cases of serious drug use, but they urged regulators around the world, to be consistent in its approach to the research results."The mechanism of action of oseltamivir should be independently investigated, especially with regard to any direct or centrally acting drug Tamiflu to get a clear picture of the impact of complications from influenza, transmission and antibody actions that can be clarified," they write."We all, as taxpayers, are interested in this drug," Dr. Jefferson said, Medscape medical news. "No other product that I think is raised in the U.S..""We can not tolerate the situation where the unnamed people make decisions about drugs that affect us all."The study received funding from the National Institute of Health Research Health Technology Assessment program in the United Kingdom. Dr. Jefferson was an ad hoc consultant to F. Hoffmann-La Roche Ltd. from 1998 to 1999. He receives royalties from his books published in the Blackwell and Il Pensieri Scientifico Editore, none of them are neuraminidase inhibitors. He interviews some market research companies in an anonymous interview about the stage 1 or 2 products outside the neuraminidase inhibitors. Dr. Doshi has disclosed no relevant financial relationships.