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Tamiflu: Manufacturer keeps study data under lock and key
Researchers from the Johns Hopkins University School of Medicine in Baltimore (USA), the Cochrane Collaboration in Rome and the Australian Bond University have massively criticized the confidentiality of data on the flu drug "Tamiflu" in the specialist journal "PLoS Medicine". Without the full publication of the study results, the benefit and risk of the drug cannot be adequately assessed, according to the scientists.
Medicines are primarily produced by pharmaceutical manufacturers to make money and only secondly is the health of patients. There may also be an interest in the distribution of almost ineffective preparations. In order to prevent this, sufficient data must be made available for the approval of medicinal products, which prove the effectiveness and discuss in detail other risks and impending side effects. Although the comprehensive studies required for the approval of Tamiflu were certainly available, the data have been guarded like a state secret since then, the scientists criticize. Possibly for good reason, since there could be indications that Tamiflu does not have the desired effect and is associated with numerous side effects.
Studies on the effectiveness of Tamiflu are kept secret Peter Doshi from the Johns Hopkins University School of Medicine in Baltimore, Tom Jefferson from the Cochrane Collaboration in Rome and Chris Del Mar from the Center for Research in Evidence-Based Practice at the Australian Bond University currently report in the specialist magazine "PLoS Medicine", from a real data secret that is made around the studies on Tamiflu. The scientists had access to thousands of pages of study data and evaluated them, but were denied full access to the available data. While this data is available from the U.S. and European regulators, it assures manufacturers when submitting that "all data will be treated as business secrets." For independent scientists, access to the complete data is almost only with the support of Manufacturer possible. This leads to a precarious situation as soon as - as in the case of Tamiflu - doubts about individual active substances arise and researchers want to check their suitability. For pharmaceutical manufacturers - in the case of Tamiflu, Roche - the sales could collapse, so that the data is often only partially or not at all passed on. According to those of Peter Doshi, Tom Jefferson and Chris Del Mar an intolerable condition. Because "the public takes and pays drugs that are approved", which is why public "access to all information about these drugs" should be guaranteed, the scientists write.
Pharmaceutical company refuses to disclose the data The first doubts about the active ingredient Tamiflu were raised when it was approved in 1999 and were confirmed in 2009 by a contribution in the specialist magazine "BMJ", after which the pharmaceutical company Roche had emphasized, according to Doshi, Jefferson and Del Mar that they were "very happy to have their data evaluated by the responsible authorities or individuals" and will publish all study reports on ten experiments "in the coming days". However, this did not happen "despite extensive correspondence over the next year and a half" According to the scientists, the company has so far refused to disclose extracts from the reports on the ten clinical trials, criticize Doshi and colleagues, but the researchers did not believe that any of the “reasons for refusing to provide full reports on Tamiflu” were credible. “The effect of the active ingredient Tamiflu is accordingly still extremely controversial.
Tamiflu recommended as a flu drug despite doubts as to its effectiveness The US Food and Drug Administration (FDA) had already expressed considerable doubts about the benefits described when Tamiflu was approved. Tamiflu claims that the secondary complications of a flu infection are incomprehensible, the FDA warned Roche. The FDA was also unable to confirm the effectiveness of "Tamiflu in preventing the transmission of influenza," reports Doshi, Jefferson and Del Mar. The US regulatory agency "has never resolved the many discrepancies in claims regarding the effects of Tamiflu," said the accusation of the scientists and the reason for their investigation. The approval and further use of Tamiflu was based, according to the researchers, on the data from ten drug studies by Roche from the 1990s, which were revised in a meta-study from 2003. Although both the FDA and numerous scientists expressed clear doubts about the effects of Tamiflu, the flu drug was a successful product for Roche. Because Tamiflu not only received approval from the FDA, it was also recommended by the European Medicines Agency as well as by the German Federal Institute for Drugs and Medical Devices, the Australian approval authority and the World Health Organization (WHO) as a suitable influenza drug. Most recently, WHO had put Tamiflu on its list of essential medicines. But if the "FDA is right, the effectiveness of the drug cannot be better than that of aspirin or acetaminophen (acetaminophen)", according to the current statement by Doshi and colleagues.
Billions in cost of an unnecessary and potentially ineffective drug Tamiflu has long been recommended by health authorities as the only active ingredient against all influenza diseases - including avian and swine flu - on the assumption that Tamiflu will reduce the number of hospital admissions and reduce secondary complications and can reduce the duration of the disease. For fear of new flu agents and possible pandemics, the states began to buy up and store masses of the active ingredient. When in doubt, everyone wanted to be prepared. A blessing of money for the pharmaceutical company, as the USA alone ordered Tamiflu with an estimated value of $ 1.5 billion. In Germany, too, Tamiflu stocks were formed in the individual federal states for fear of bird flu in 2005/06, with sufficient active ingredients being purchased for a third of the population. Experts estimate that the expenditure in this country amounted to around 300 million euros. Fortunately, Tamiflu was not used, especially since, according to the statements of Doshi, Jefferson and Del Mar, use in an emergency might not even have had the desired effect. The expiry date of the stored active ingredient will soon be exceeded, and theoretically it would then be necessary to procure new stocks. But should 300 million euros actually be spent again on a drug that, in case of doubt, does not work better than aspirin? Given the current allegations by Peter Doshi, Tom Jefferson and Chris Del Mar, this can only be discouraged.
Approach of the pharmaceutical company arouses mistrust In view of the massive doubts that have been expressed about the effects of Tamiflu in recent years, the three researchers carried out a so-called Cochrane report, which assessed all data independently and should take into account all studies to date. However, the researchers were given limited access to the required data. The pharmaceutical company Roche has always replied to the 16 inquiries that were made by the researchers from October 2009 to February 2011, but did not provide the desired data or only provided extracts, according to the criticism in the current article by Doshi, Jefferson and Del Mar. With ever new flimsy arguments, the pharmaceutical manufacturer refused to provide the full study data. Such an approach arouses particular mistrust, since the effects of Tamiflu are questioned anyway.
Ethical arguments speak for a comprehensive publication of all study data. Although the researchers use the direct example of Tamiflu in their contribution, the criticism also relates to the general handling of the study results for approved active substances. "There are strong ethical arguments for making all clinical trial reports publicly available," emphasized Doshi, Jefferson and Del Mar. It should also be borne in mind that clinical trial participants are believed to "contribute to medical research." "A" non-disclosure of the full study results undermines the philanthropy of the human participants "and stands in the way of the quest for knowledge, according to the researchers. It is also fatal when the pharmaceutical manufacturers proceed that the trust in the free exchange of research data for the protection of the population is being undermined. In this way, the population lost hope that politicians and authorities can intervene in a regulatory manner, the scientists explained.
Inappropriate study results are often kept under lock and key. However, in the case of Tamiflu, the regulatory authorities are partially responsible, as they have given approval despite doubts about the effectiveness. The fact that the pharmaceutical manufacturers tend to keep secret unpleasant results on their own instills suspicion, but is still understandable from a purely business perspective. Legislators must intervene here and oblige manufacturers to disclose all study results, Doshi and colleagues demand. All studies should also be registered as soon as they start, so that in the end unsuitable results cannot easily disappear. Experts from the German Cochrane Center estimate that this fate overcomes about 50 percent of the studies, which shows how high the level of confidentiality here is. However, according to the head of the German Cochrane Center, Gerd Antes, not only pharmaceutical manufacturers but also university hospitals and institutes are participating in this unworthy game. (fp)
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