Last week
prominent medical experts said that new data from Merck indicated that Vioxx's risks started to emerge after only four months of use. The controversy is the latest illustration of how widely open to interpretation and potential corporate pressure the results of clinical trials can be — even when reported in a leading medical journal.
Critics say it is now clear that the previous data analysis was done in a way that minimized the risks of the drug. Some also say that Merck and its academic collaborators should have known about that four-month threshold and made the earlier risks clearer in a medical journal article in March 2005.
It was the first scientific report of the clinical trial results that had prompted the company to withdraw the drug. That article, in The New England Journal of Medicine, concluded: "The increased relative risk became apparent after 18 months of treatment."
The conclusion "makes the drug look a lot safer than it was," Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said last week after reviewing the new data.
I guess conspiracy theorists will claim that the drug companies initial interpretation was self-serving. It seems more likely that it is simply a case in which reinterpretation of data in light of knowledge gained in the interim allows more careful analysis and conclusions. Of course, people are people, and scientists often are optimistic in their search for results. But I assume no scientist wants his results and interpretations to put his client in the position that Merck no finds itself with respect to Vioxx. I am pretty certain that the journal's reviewers would not have wanted to approve for publication a report that ran into the kind of criticism now directed at the first publication of Vioxx clinical trials.
In any case, the story illustrates just how hard it is to develop good knowledge for development!
No comments:
Post a Comment