Tamiflu manufacturer withholds trial data

Tamiflu: Manufacturer keeps study data under lock and key

04/13/2012

Researchers at the Johns Hopkins University School of Medicine in Baltimore, USA, the Cochrane Collaboration in Rome and the Australian Bond University have featured in the journal „PLoS Medicine“ the confidentiality of data on the flu medication „Tamiflu“ critically criticized. Without the complete publication of the study results, the benefit and the risk of the active substance can not be sufficiently estimated, so the reproach of the scientists.

Medicines are primarily produced by pharmaceutical manufacturers to earn money and second only to the health of patients. So there may 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 to prove its efficacy and to discuss other risks as well as the potential side effects in detail. Although the comprehensive studies required for the approval of Tamiflu have certainly been available, the data has since been guarded as a state secret, the scientists criticize. Perhaps for a good reason, there may be some evidence 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 Baltimore Johns Hopkins University School of Medicine, Tom Jefferson from the Cochrane Collaboration in Rome, and Chris Del Mar from the Center for Research's Evidence-Based Practice at the Australian Bond University are currently reporting in the journal „PLoS Medicine“, of a veritable data secret that is being done about the studies on Tamiflu. The researchers had access to thousands of pages of study data and evaluated them, but they were denied full access to the available data. While these data are available from US and European regulators, they do assure manufacturers of submission, „to treat all data confidentially as trade secrets.“ For independent scientists, access to the full data is therefore almost entirely possible with the assistance of the manufacturers. This leads to a precarious situation as soon as - as in the case of Tamiflu - doubts arise on individual drugs and researchers want to check their suitability. For the pharmaceutical manufacturers - in the case of Tamiflu, the company Roche - could threaten a slump in sales, so that the data are often only in excerpts or not at all. According to Peter Doshi, Tom Jefferson and Chris Del Mar, an unsustainable condition. Because „the public takes and pays for medications that are approved“, which is why a public one „Access to all information about these medicines“ should be guaranteed, write the scientists.

Pharmaceutical company refuses to release the data
First doubts about the active ingredient Tamiflu came already with the admission in the year 1999 and became in the year 2009 by a contribution in the trade magazine „BMJ“ According to Doshi, Jefferson and Del Mar, the pharmaceutical company Roche emphasized that they were „very happy to have his data evaluated by the respective competent authorities or individuals“ and will „publish all the study reports on ten experiments in the coming days, but this is true „despite extensive correspondence over the next year and a half“ did not happen, so the charge of scientists. So far, the company refuses to announce more than excerpts from the reports of the ten clinical trials, criticize Doshi and colleagues. The researchers did not appear to have mentioned any of these „Credible reasons for refusing full reports of Tamiflu.“ The effect of the influenza drug Tamiflu is therefore still highly controversial.

Despite doubts about the effect Tamiflu recommended as a flu remedy
Even the US Food and Drug Administration (FDA) had already expressed considerable doubts about the described benefits when it came to the approval of Tamiflu. The claim Tamiflu reduce the secondary complications of a flu infection is incomprehensible, the FDA warned the manufacturer Roche. Also, the FDA was able to reduce the effect of „Tamiflu in the prevention of transmission of influenza“ Not confirmed, report Doshi, Jefferson and Del Mar. The US regulatory agency „never clarified the many inconsistencies in claims about the effects of Tamiflu“, so the reproach of the scientists and the grounds of their investigations. The approval and continued use of Tamiflu were based, according to the researchers, on the data from ten drug studies by Roche from the 1990s, which were revised in a 2003 meta-study again. Although both the FDA and numerous scientists expressed clear doubts about the effects of Tamiflu, the influenza drug became a successful product for Roche. Because Tamiflu was not only approved by the FDA, but was also recommended by the European Medicines Agency, as well as the German Federal Institute for Drugs and Medical Devices, the Australian Regulatory Authority and the World Health Organization (WHO) as a suitable flu drug. Most recently, WHO put Tamiflu on its list of essential medicines. But if the „FDA reserves right, the effectiveness of the drug can not be better than aspirin or acetaminophen (acetaminophen)“ be, so the current statement of Doshi and colleagues.

Billions in costs for an unnecessary and potentially ineffective drug
Tamiflu has been recommended by the health authorities for years as the only active ingredient against all influenza - including bird and swine flu - in the belief that Tamiflu can reduce hospital admissions, reduce secondary complications and reduce the duration of the disease. Fearing new influenza viruses and possible pandemics, the states began buying up and storing bulk of the drug. In case of doubt everyone wanted to be prepared. For the pharmaceutical company a blessing, but ordered the US alone Tamiflu in the estimated value of $ 1.5 billion. In Germany too, Tamiflu stocks were created in the individual federal states for fear of bird flu in 2005/06, whereby sufficient active substance was purchased for one third of the population. According to experts, expenditure in this country amounted to around 300 million euros. Luckily, Tamiflu was not used, especially since, according to Doshi, Jefferson and Del Mar, using it in an emergency might not even have had the desired effect. Soon, the expiration date of the stored drug will be exceeded and theoretically, the procurement of new stocks would be pending. But should actually again spent 300 million euros for a drug that does not work better than aspirin in case of doubt? Given the current allegations of Peter Doshi, Tom Jefferson and Chris Del Mar can only be discouraged.

The action of the pharmaceutical company arouses mistrust
The three researchers carried out a so-called Cochrane report, given the massive doubts expressed in recent years on the effects of Tamiflu, which should independently evaluate all data, taking into account all the studies available to date. However, access to the necessary data was limited to the researchers. The pharmaceutical company Roche has responded to the 16 inquiries made by the researchers from October 2009 to February 2011, always responded, but the desired data or not in excerpts delivered, so the charge in the current article by Doshi, Jefferson and Del Mar. With ever new flimsy arguments, the pharmaceutical manufacturer denied the publication of the complete study data. Such a procedure arouses particular suspicion, since the effect of Tamiflu is already called into question.

Ethical arguments speak in favor of a comprehensive publication of all study data
Although the researchers take up the direct example of Tamiflu in their article, the criticism also refers 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“ Doshi, Jefferson and Del Mar emphasized that it must also be taken into account that the participants in clinical trials are of the opinion, „to contribute to medical research.“ A „Non-disclosure of the full study results undermines the philanthropy of human participants“ and contrary to the pursuit of knowledge, so the statement of the researchers. It is also fatal in the approach of the pharmaceutical manufacturers that the trust in the free exchange of research data for the protection of the population will be undermined. In this way, the population loses the hope that regulators can intervene politically and authorities, the scientists said.

Inappropriate study results are often locked up
However, in the case of Tamiflu, the regulatory authorities themselves are partially to blame, as they have granted marketing authorization despite doubts about the effect. The fact that pharmaceutical manufacturers tend to keep unpleasant results secret is a source of mistrust, but from a purely business perspective it is still understandable. Here, the legislature must intervene and commit the manufacturers to announce all study results, demand Doshi and colleagues. Also, all studies should be registered as soon as they start, so that in the end inappropriate results can not easily disappear. According to experts from the German Cochrane Center, this fate is met with around 50 percent of the studies, which shows how high the secrecy interest seems to be here. However, according to the head of the German Cochrane Center, Gerd Antes, not only pharmaceutical manufacturers but also university hospitals and institutes participate in this unworthy game. (Fp)

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Picture: Gerd Altmann