May 29, 9:00 PMHealthy Living ExaminerNorma Erickson
Every single day, doctors make life or death decisions regarding your health based on information from clinical trials. What happens when the information they base their decisions on is inaccurate, or misleading?
An article published in the Journal of the American Medical Association (JAMA), July 2000, stated that 106,000 people each year die from non-error adverse reactions to medications. Perhaps the way clinical trials are conducted and how the results are reported has something to do with the recent epidemic of medical errors.
Consider the fact that there is no benchmark for clinical trials. Each trial is designed by either the sponsor of the trial, or the scientists and researchers conducting the trial. A trial conducted with several thousand participants is more likely to provide useable data than one conducted with only a few participants. The length of the trials will have an impact on the outcome. Whether the participants are healthy, or have a pre-existing medical condition, has a bearing on the outcome. There are hundreds of factors to consider when designing a clinical trial. Each single factor has a bearing on the potential outcome.
There is no regulation requiring the results of any non-government sponsored clinical trial be published. In 2008, the FDA examined 74 privately sponsored clinical trials conducted on antidepressants. They found that 38 of the trials reported positive results; 37 of them were published. 36 of the clinical trials had negative or questionable findings; 22 were not published at all. The 11 that were published, were published in a way that indicated the results were positive, even though they were not.
According to a Erik Turner, a former FDA employee,
When studies of anti-depressants were negative, they were reported as negative only 8% of the time, but when studies were positive they were reported 97% of the time.
The sponsor of the clinical trial may determine whether the results are positive or not. According to FDA records, clinical trials sponsored by the pharmaceutical industry are favorable 87% of the time. Those trials sponsored privately are only favorable 65% of the time.
The clinical trials may never have been conducted at all. According to the Office of Research Integrity, there were 37 cases of medical research misconduct that ended in disciplinary action from 2006 to January 2010. Several of these cases involved falsification of research data. One doctor was accused of fabricating data on 21 research papers for several medications that have since been pulled from the market. (See individual case reports here.)
Every single drug, vaccine, medical device and medical treatment is approved based on the outcome of clinical trials conducted to determine the safety and efficacy of said treatment. When the results reported are faulty, or misleading, the decision to approve is faulty.
How can we expect our physicians to make sound decisions regarding our health, and perhaps our very survival when they cannot rely on the data presented to them?