The Wall Street Journal recently published an article entitled “What You Don’t Know About a Drug Can Hurt You.” They reported that there are currently 2.3 million patients participating in about 50,000 clinical trials, through $58 billion of privately funded drug research. Medical research analysts have concluded that the sheer volume of clinical research has overwhelmed the ability of medicine to assess these trials independently—or even to make those results public. The result is that many clinical studies that test prescription drugs will never see the light of day.
Most people assume the FDA drug approval process includes both testing and disclosure. Unfortunately, the testing is by no means exhaustive, but even that is more rigorous than the disclosure. The FDA acknowledges that many new drugs are approved on the basis of a few studies which include far fewer volunteers than those to which the drug will be prescribed. According to the director of the National Library of Medicine’s online clinical trials registry, Dr. Deborah Zarin, “There is data that you are not seeing. There is a huge problem here if an unknown amount of the information is censored and you don’t even know it is censored.”
While there have been reforms over the past four years, including an online database created by the Pharmaceutical Research Manufacturers Association of America to summarize clinical study results that involve hundreds of prescription drugs, there have been many drug scandals over deceptive marketing, unreported side effects, and hidden payments to drug researchers. And health risks and benefits can be covered by selective reporting and by spin doctoring. A Mayo Clinic medical policy analyst, Dr. An-Wen Chan, said, “Journals want to sell journals; companies want to increase profits; and researchers would like to advance their careers. They can conflict. Sometimes, decisions are not made in the best interest of the patients.”
Researchers now face fines of $10,000 a day and loss of federal research funding if they fail to report basic data about clinical test results on the federal public registry. However, the registry only covers new tests. Serious side effects must be reported to the registry beginning in 2009, though that reporting will not be formally verified, and Dr. Zarin reports, “The companies are still fighting every step of the way.”
FDA reform is critical not only because of unpublished clinical studies, but also for a wealth of reasons cited in previous issues of this newsletter, or by sources such as Dr. Joe Mercola and Mike Adams. Visit www.ReformFDA.org and register your support of complete reform of the FDA.