Cynical Trials?
When such eminent journals as The Lancet, the New England Journal for Medicine and the Journal of the American Medical Association write editorials that question the validity of clinical trials (CTs) and suggest that the studies produced for publication may be written slanted to the interests of the pharmaceutical companies, it is time for the industry to take note and, perhaps, put its house in order.
The editors say that the studies produced for publication may be skewed for the pharmaceutical companies, hoping to make big profits from a new drug. The scientists, often from cash-starved universities or departments, may be prevented from having access to the raw data garnered in the clinical trials, which would tell them how well the drug worked and whether there were side-effects. Even a hint that CTs may not be being carried out with complete transparency could cause the industry problems.
Given that the trials being talked about are the ones that could produce another drug which could, possibly, have the same effects has thalidomide, or which produced Lipobay/Baycol, it is thankful that the media didn't go to town with horror stories, as they do when there is a train crash, or air disaster. Fortunately, although the national press picked up on the story, there was a measured response in most media. Unfortunately, the general public tend to have a negative perception of scientists and science. Generally, scientists are seen as not to be trusted; they are boffins who sit in ivory towers with little reality of the real world. The problems with TSE and FMD, which is actually more to do with lack of government responsibility and vascillation than scientists getting it wrong, increase this perception.
Ironically, I have just come back from a conference about regulation in the pharmaceutical industry and it included a talk about revison of the centralised procudure (CP) for drug licensing, which is being modified by the EU Commission. Regulation 2303/93 also called for a review of the MR and CP procedures by 2001. These reviews are now being finalised and the CP has future implications for the licensing of drugs in Europe. In other words, the industry, which is already highly regulated, is becoming more so.
It would be a shame to undermine this confidence for the sake of profit.
From next month, MC will have a new Editor, Hilary Ayshford. Many of you will know Hilary as she comes from the packaging industry, which, of course, encompasses pharmaceutical products, and I am sure she will have a range of new ideas to complement the already high quality editorial seen in the magazine.