Although many drugs have been through a regulatory approval process, which includes the necessary clinical trials route (where drugs are tested for safety and efficacy), several do not meet the required rigorous standards. This is the conclusion of a review made by NYU Langone Medical Center’s Division of Medical Ethics in the Department of Population Health.
Any research into clinical trials is hampered by the refusal by many pharmaceutical companies to publish all of the information collected when running clinical trials. However, by piecing together what has been released, NYU Langone has managed to rank specific medicines based on a pharmaceutical company’s legally-required disclosure of clinical trial information against their ethical obligation to share information.
The scorecard, according to Pharmaceutical Processing magazine, assesses all U.S. drug approvals since 2012 and the plan is to make revisions to the scorecard an annual event.
The findings are somewhat concerning. About 50 percent of the drugs reviewed had at least one undisclosed clinical trial. This means that tests were conducted that medical doctors and patients do not know about.
Furthermore, it was found that only 57 percent of trials per drug were properly registered. In addition, only 20 percent of final results were reported to the National Library of Medicine at the U.S. National Institutes of Health, which is where doctors can access information. To add to this, only 56 percent of trials have been published in peer reviewed journals.
The implications of the study are that laws relating to pharmaceutical companies in the U.S. are too narrow and those that are in place are too often not enforced. The authors of the scorecard are worried about what they term “selective disclosure.”
The findings are published in the journal BMJ Open. The article is headed “Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.”
