A recent study published in the New England Journal of Medicine (NEJM) found that manufacturers of antidepressant medication often don’t publish drug trials that show negative results – leaving doctors and consumers without all the information they need to make an informed decision about treatment options.

The study

In the study, published in the NEJM in January 2008, researchers reviewed antidepressant drug trials that were submitted to the Food and Drug Administration (FDA) over a 17 year period (1987 to 2004) involving 74 trials that included over 12,500 patients and 12 antidepressants. They found that nearly 86% of the negative results were never made public, whereas nearly all (94%) of the positive results were made public.

Industry analysts say that drug companies, and those in other industries, often bury information negative results in order to gain approval from the Food and Drug Administration (FDA) and to sell more of their products to doctors and consumers.

Drug industry creates website

Representatives from the pharmaceutical industry have already discounted the study’s findings saying that drug trial reporting has significantly changed since 2004. In particular, they point to a website created after 2004 that allows practicing physicians, patients and others to obtain clinical study results. However, according to the website, www.clinicalstudyresults.org/, which was created by the pharmaceutical industry, the data provided is strictly voluntary. According to the website:

PhRMA’s (Pharmaceutical Research and Manufacturers of America) Board of Directors – the leaders of America’s pharmaceutical companies – agreed that member companies will participate in and support the database and . . . communicate all meaningful results, both positive and negative.

Federal government creates it own website

Perhaps the government wasn’t convinced of the altruistic sentiment of the PhRMA, but it created its own website, www.clinicaltrials.gov/, to provide an additional venue to report on drug trials. The site provides up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. However, the information contained on their database, although reviewed by the National Library of Medicine, is also voluntary.

So, where does that leave consumers?

Unfortunately, back at the starting gate. Consumers who have experienced a problem with a drug should contact a qualified attorney whose practice focuses in this area of law to discuss what is known about the drug and what options or recourse might available. To contact an attorney for a free, no-obligation consultation, please click here.<