NEJM: Another Reason Why Transparency Is Needed In Drug Manufacturers’ Clinical Trials

On January 17, 2008, the New England Journal of Medicine released a study that put numbers to what we already knew to be true: drug manufacturers have more data, particularly negative findings, that they are not making public. Examining the literature concerning antidepressants, the study showed that 94% of the studies published by drug manufacturers discussed only the positive effects of the medication being studied. Drug manufacturers must report the results of all clinical trials to the FDA. When the entirety of the data submitted to the FDA from the manufacturers’ trials was examined, however, efficacy was shown in only 51% of the studies.

Why would this be the case? One could suppose that journals are more interested in publishing data establishing efficacy, as it may be deemed more “exciting,” perhaps medicine’s version of the newspaper adage, “if it bleeds, it leads.” But the more likely reason is what is found in most drug and products liability litigation: it is not in the corporation’s economic interests to release negative information about a product. This is the prime motivator behind the drug manufacturers’ decisions to focus its publication efforts on only those studies that show efficacy, which would, of course, encourage physicians to prescribe and consumers to use the medications, thereby increasing sales.

The FDA Amendment Act of 2007 passed by Congress last September offers a partial solution to the dilemma. It requires that the data from all the clinical trials performed by the manufacturer and submitted to the FDA be made available to the public. The NIH and FDA will be responsible for maintaining a database of the clinical trials completed by manufacturers. The public will have access, however, only to data on drugs the FDA has approved for sale.

We have seen stunning and regressive changes during the Bush administration concerning information such as this, where scientific data and thought were suppressed for political purposes. Allowing researchers, clinicians, and the public access to this type of scientific data is the only responsible thing to do, and it should have happened long ago. Let the sun shine in.

Source: New England Journal of Medicine, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, Volume 358:252-260 January 17, 2008 Number 3 ; www.fda.gov