Clinical trials of drugs generally report positive
and negative results. Those results are then analyzed to determine whether a drug is safe for the general public’s use. However, a newly published study says that when clinical trials that report negative drug results are stopped early, the drug’s true effectiveness may be tainted.
New concerns raised
The Annals of Oncology, a journal that publishes articles addressing medical oncology, surgery, and other areas, looked at all published clinical trials in the past 11 years regarding anticancer drugs that were stopped early. The study, available online at http://annonc.oxfordjournals.org/, concluded that:
Though criticism of the poor quality of oncological trials seems out of place, unfortunately early termination raises new concerns. The relation between sparing patients and saving time and trial costs indicates that there is a market-driven intent. We believe that only untruncated trials can provide a full level of evidence which can be translated into clinical practice without further confirmative trials.
Unfortunately, the data from these trials is often used to seek drug approval.
Tainted information
The Wall Street Journal’s Health Blog recently published an article which looked at 25 cancer trials stopped early over a 10 year period. The article, available at http://blogs/wsj.com, reports that the data from 75% of those stopped trials was used to apply for drug approval by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) – Europe’s version of the FDA.
Industry analysts say that not providing these agencies with all the data, good or bad, tends to favor drug approvals. They allege that it’s a way for drug manufacturers to get their drugs approved more quickly, but that consumers of the drugs may end up suffering from unknown, or unreported, side effects in the long run.
If you’ve been injured due to a harmful drug, contact an attorney whose practice focuses in this area of the law. Countless numbers of drugs that have been approved by the FDA have later proven to be unsafe – many times due to tainted information that drug companies provide to the FDA.
If you’d like to discuss your situation with a qualified attorney, please click here. Consultations are free, without obligation and strictly confidential. We may be able to help.
