The FDA is keeping the public in the dark about scientific fraud


FDA Caught Covering-Up a Laundry List of Fraudulent Studies

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.

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).”

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:

-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.


Image Background: Wikimedia Commons


2 Responses

  1. CDER is part of the FDA. I learned that 80 percent of the medications we take are Not Officially Approved by the FDA- But Center for Drug Evaluation and Research=CDER supposedly have to demonstrate SOMETHING in order for it to get to market. However, it is stated that some “Clinical Trials”, (ones we aren’t informed of) even the drugs we thought were the same, but No one Notified Us Of Extreme Formulary Changes, get enough of ???? to be fraudulently sold to us W/O Any notice of Anything different. I have no other choice except to know from personal experience that the ONLY REASON for the existence for CDER is to prolong Lawsuits and ONLY IF THEY ARE CAUGHT.

  2. While I am AGAIN disappointed in our Federal agencies and their betrayal of our trust, I am even more disturbed that the FDA is not only falsifying clinical trials results to allow these meds be sold to us, but seem to be dragging their feet on approving ketamine, an anesthetic that has been around for many years. Ketamine has been known to the medical and scientific communities as a hypnotic that affects our NMDA receptors.
    Psychiatric meds iused to treat “clinical depression”, now called Major Depressive Disorder (MDD) in the 50s were either MAOIs or tricyclic anti-depressants-elavil, tofranil etc. Then the breakthrough of SSRIs, then SNRIs of the 80s through today. They are touted as almost totally successful in treating MDD, which any patient with MDD knows is not true…..around 40% of those diagnosed with MDD will not respond to either category of anti-ds. Our condition is called Treatment Resistant Depression. I went through close to a dozen anti-d combos for 6-8 weeks each-in other words, years. I signed on for 18 ECTs, which yielded 0 improvement in my mood, and torched some large memory banks in my drug-addled brain.
    Ketamine was proved VERY successful in many small scale trials. FDA gave iot “breakthrough” designation. That was at least 4 years ago. Since then slightly different forms of ketamine, namely esketamine have been trialed and done very well. Some patients only needed one set of ketamine infusions (3 in a week) with small booster months later. Anecdotal tales of one infusion reversing depression (in TRD patients) ARE MANY. Because it has shown up as a street or club drug, MDs and others are dragging feet, especially in the “Opioid Hysteria”. Trials use very small amounts, as little as one-tenth of club drug dosages. Reports of “bad tri[ps” are hyped.
    Is it because ketamine will not yield trillions in profit? Or members of psychiatry, psychology, mental health clinics and in patient facilities fear the death of their bread and butter? Can anyone tell me why we have not seen a drug with the potential (studies show reversing of ER suicidality is hugely successful with one shot of ketamine) to alleviate the global suffering and death from the world’s 2nd leading cause of disability?
    Do some real good, FDA, and allow this med onto the market today!
    If the bastards take away my pain meds, then my benzodiazepines, you could at least help lessen my crippling TRD!

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