Does oseltamivir, better known as Tamiflu, to prevent complications from influenza, as pneumonia and influenza? We are no longer safe, the Cochrane Collaboration, an international group that produces reviews of the medical literature, said in an article published online by the British Medical Journal (BMJ) last night. Last year, the Cochrane Collaboration has issued a much more positive about the benefits of the top-selling drug. The problem, said the panel of four members who wrote the new review, is that Roche, the manufacturer of Tamiflu, has failed to make full eight public studies underlying the earlier verdict.
The question of Tamiflu effectiveness is timely because governments have invested billions to get drugs to prepare for a flu pandemic. The new study does not directly address its role in the treatment of H1N1 swine flu, though; it deals with the effectiveness of Tamiflu against the seasonal flu. The document is part of a huge package posted by BMJ last night. In addition to the review itself, there is an article documented how the panel arrived at its conclusions by Peter Doshi, a doctoral student at the Massachusetts Institute of Technology program in history, anthropology , science, technology and society, which is listed as one of the four authors of revision as well. A BMJ staff writer, Debra Cohen, told the story in another article that also uncovered alleged irregularities in the way of the past oseltamivir studies were conducted and written, there including the use of writers ghosts. The newspaper also published a short Roche response, an item reply with extended point in which the company addresses each of BMJ 's concerns, and an editorial BMJ E ditor Fiona Godlee and Director Mike Clarke Cochrane Collaboration. BMJ 's survey was conducted in conjunction with the Channel 4 Britain, which aired a film on the controversy last night.
What happened? Here's the short version:
The team, led by Chris Del Mar from Bond University in Australia, launched an update of the Cochrane review in 08 at the request of the National Health Research Institute UK in August. Just a few weeks ago, the team had received an email from a Japanese pediatrician, Keiji Hayashi, who questioned the validity of one of the documents relied on by the revision of 08. This document - published in 03, Laurent Kaiser Hospital Cantonal Geneva as the first author was a meta-analysis of 10 trials sponsored by Roche oseltamivir. Only two of them had been published in journals, peer-reviewed, Hayashi stressed; the other eight were unpublished or published only in abstract form. Hayashi challenged the Cochrane team to "evaluate the 8 trials rigidly."
According to the account of Doshi, panelist Tom Jefferson, the first author of the study in 08 and the only member of this group was also involved in the new analysis -asked the authors of the article Kaiser send data over the eight trials. When they could not, Jefferson contacted Roche to get the information. The company said it would make available studies, but only if Jefferson signed a confidentiality agreement also contained a clause "not to disclose ... the existence and terms of this Agreement." Apparently Doshi wrote Roche "is not only to keep her hidden data, but also to hide the fact that he was VALIDATION people by a secret clause."
the team found that unacceptable, and after a bit e -mails more back and forth, he decided to exclude the Kaiser meta-analysis of its reconsideration. They were left with a total of 20 trials that together have allowed the conclusion that Tamiflu was "modest efficacy against the symptoms of influenza in healthy adults "and that it" might be considered optional to reduce the symptoms of seasonal flu, "but that" lack of good data has undermined previous findings for the prevention oseltamivir for flu complications. independent randomized trials to resolve these uncertainties are needed. "
The experience has left four members with serious doubts about the way the Cochrane Collaboration does its business." The reviews have endorsed the conclusion that oseltamivir reduces complications such as pneumonia and bronchitis by implicitly confident that unpublished data were verifiable, "Doshi wrote. "This confidence now seems naive."
In response point by point James Smith Rock, international medical leader for Tamiflu, Roche said that now publishes all of its clinical trials, but it was not standard procedure in the industry it are 7 to 10 years. "At the time, it was considered that the studies that have been published (2 abstracts and full manuscripts 2) accurately reflect the benefits of the drug," Smith wrote, "and that additional studies provided little new information and would be unlikely to be accepted for publication by most reputable journals. "
Smith adds that the supply of data under a confidentiality agreement is" commonplace within the scientific community to ensure responsible use of data, "and said that group UK 'Medical Research Council (MRC) recently agreed to such a deal. But the paper does not explain why the existence of the transaction itself needed to remain a secret.
Roche also denies most of the allegations in the instance of story-characteristic of Cohen, that the authors of Roche sponsored studies were pressured by the company marketing people to talk the importance of flu. Roche recognizes that medical anonymous authors have been involved in at least one of the documents, but the company says that it was common practice at the time, prior to the so-called good practice guidelines published effects 03.
Whether the blow to Tamiflu image is permanent remains to be seen. If the MRC group that has access to the complete database Roche is working on a same view and believes that the eight studies were conducted properly, it could reach a different conclusion.
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