Posted by: Stephanie Vick, staff writer in Science News February 24, 2015
When Seife received his information, he learned that 22 clinical trials submitted to the FDA were falsified, and the results of these falsified trials were not revealed to the public.
With his students assisting him, Professor Seife compared the FDA’s actions regarding these trials against information on them in peer-reviewed studies. The results of Seife’s investigation were recently published in the online journal, JAMA Internal Medicine.
When this is required, paperwork regarding the trials is traditionally marked as “official action indicated (OAI).”
Seife’s investigation revealed that 57 trials received the OAI indicator for everything from bad record keeping (35 studies) to actual falsification of results (22 studies). The affected trials took place between 1998 and 2013. The FDA never informed the public of these findings or of any actions taken against the facilitators of the studies.
It is no longer a ‘secret’, the FDA has violated the public trust. This is the same organization that refuses to label seafood that has mercury – a known neurotoxic (heavy metal) substance; allows the deadly (artificial) sweetener aspartame to be sold in food products and gives its approval to drugs that cause harm.
By allowing falsified results of clinical trials to remain in publications with no retractions required, the FDA is violating the public’s trust. The public has a right to expect transparency from the FDA, as the health and safety of America’s people depend on it.
Professor Seife has stated that the FDA seldom takes any action to make sure falsified study results are corrected in the medical literature, even when it finds significant departures from good study practices. And, the only reason why the FDA has not been taken down is because the federal government, its regulatory agencies and the U.S. legal system work together to protect corporate interests – while minimizing its exposure to lawsuits.
And, just in case you have any doubt how bad this organization really is – consider this quote from a credible source:
“The thing that bugs me is that the people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.” – Herbert Ley Jr., M.D., former Commissioner of the FDA.
In fact, here are several examples of how the FDA deliberately withholds lifesaving information from the general public:
- Between 1992 and 1996, the FDA prohibited companies that sell folic acid from telling women of childbearing age that .4 mg of folic acid daily before pregnancy could reduce the incidence of neural tube defects (including spina bifida and encephaly) by 40%. FDA’s censorship contributed to a preventable 10,000 neural tube defect births.
- Between 1994 to 2000, the FDA prohibited companies that sell omega-3 fatty acids from telling Americans that those fatty acids found in fish oil could reduce the risk of coronary heart disease by as much as 50%. FDA’s censorship contributed to a preventable 1.8 million sudden death heart attacks.
- Between 2000 and the present, FDA prohibits companies that sell saw palmetto extract (the fruit of the dwarf American palm tree) from telling Americans that saw palmetto reduces enlarged prostates and relieves related symptoms. Approximately 50% of all men age 50 and older suffer from enlarged prostates and are denied access to this information.
- Between 2000 and the present, FDA prohibits companies that sell glucosamine and chondroitin sulfate from telling Americans that those dietary ingredients treat osteoarthritis and relieve osteoarthritic pain and stiffness. Approximately 20 million Americans suffer needlessly from osteoarthritis.