Were you of the understanding that Congress had Oversight over the FDA?
Posted by: Stephanie Vick, staff writer in Science News February 24, 2015
(NaturalHealth365) Professor Charles Seife of the Arthur L. Carter Institute of Journalism at New York University recently uncovered some disturbing evidence about the United States Food and Drug Administration (FDA). This information came to light when he made a Freedom of Information request earlier this year.
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.
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.
The FDA is keeping the public in the dark about scientific fraud
When clinical trials are found to have violated proper practices or to have been falsified, the FDA takes regulatory action against those conducting the trials.
When this is required, paperwork regarding the trials is traditionally marked as “official action indicated (OAI).”
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.
How could the FDA allow falsified studies to be published?
While the FDA did take ‘official action’ against clinical trial facilitators who falsified results, they allowed the results to be published. No retractions for these falsified results were ever required. Studies with blatantly falsified results remain in medical journals, misleading other researchers as well as the public about the truth.
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.
The evidence is clear: The FDA does not care about public safety
When the FDA does NOT retract inaccurate and/or falsified research projects – this indicates a clear violation of their duties and obligations – both morally and professionally. In fact, the actions of the FDA are criminal – by NOT making every (reasonable) step to protect the population.
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.
The FDA consistently acts as the ‘protector’ of drug company profits and supports the monopoly-control that the pharmaceutical industry has over the world. Not only does the FDA hide fraud, they actually censor quality health information from getting into the public domain.
In fact, here are several examples of how the FDA deliberately withholds lifesaving information from the general public:
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.
This criminal behavior must be stopped. Without the correct information, other researchers, as well as the general population, are being misled and allowed to go down roads regarding their own studies, health and wellness practices – that lead to nowhere, or eventual harmful outcomes. The FDA has broken public trust; acted without regard to public safety and must be held accountable for their actions.
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