Part 4: How did Gardasil pass FDA review?

June 2, 3:05 PMVaccines ExaminerNorma Erickson

Every year, the FDA approves new treatments for the latest of designer ailments. When new drugs are approved, the decision is based on the outcomes of clinical trials. In order to make sound decisions the clinical trial information provided must be unimpeachable. Often, this is not the case.

There is virtually no regulation regarding how clinical trials are designed. Every clinical trial is designed by the sponsor of the trial (the entity paying for the research). There are many variables to be considered including number of participants, length of the study, placebo use, whether the test subjects are healthy, or have an existing medical condition, dosage, and so on. Each individual variable has an impact on the potential outcome.

Assuming the trial was well designed and properly conducted, what happens when the results are negative? Is everyone in the scientific community informed that this particular treatment did not work, so they can pursue alternate theories? Probably not.

According to 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 trial may influence the results. According to FDA records, trials sponsored by pharmaceutical companies are 22% more likely to have positive outcomes than those trials sponsored by private entities who have no vested interest in the outcome of the trials.

One of the most frightening aspects of reported clinical trials is that they may have never taken place at all. According to the Office of Research Integrity, there were 37 cases of medical research misconduct that resulted in disciplinary action from 2006 to 2010. Several of these cases involved falsification of research data. One doctor was disciplined for fabricating information on 21 research papers for several medications that have since been pulled from the market, including Vioxx and Bextra.



Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.