It has been discovered that numerous research reports regarding pharmaceutical drugs or devices and their potential for adverse side effects have gone unreported. If a clinical trial of a specific drug has already received approval by the FDA, a law requires the manufacturers to submit a report within one year of the trial’s completion. In examining the number of trials to which this law applies, researchers discovered that only 22%, 163 out of 738 trials, actually submitted reports within the year.

When examining motives for omitting the reports, Harlan Krumholz, MD, from Yale University acknowledges that while profit is a driving factor, there are other reasons for concealing these findings as well. He postulates that medical journals do not want to report contradictory or negative findings, and that researchers avoid publishing unexpected findings that disprove their theory. Whatever the motives, this lack of reporting has caused numerous adverse side effects that could have been avoided.

Take Avandia for example. At one point, Avandia was the leading diabetes drug in the United States. Since then, however, it has been linked to an increased risk of heart failure and heart-related death. Researchers discovered 42 studies suggesting a link between the diabetes drug and heart failure, but only 7 of these studies were reported; 35 were unpublished and were only released because of a judge’s order. It is likely that had the medical community known of these adverse side effects, far less people would have suffered and Avandia would not have become the leading diabetes drug.

To avoid this problem in the future, certain people in the medical community are advocating that researchers and manufacturers who fail to publish results of clinical trials in accordance with the law should be subjected to disciplinary measures. Advocates of such disciplinary measures hope that punishments, in whatever form, will discourage researches and manufacturers from skewing results of their studies. It is unclear whether or not disciplinary measures provide an adequate solution to the nondisclosure problem, but what is clear is the necessity of change in this field. Numerous people across the United States are currently experiencing adverse side effects from pharmaceutical drugs or medical devices. These situations are especially tragic when there is ample yet concealed evidence that these side effects could and should have been conveyed to the public.