The FDA Is Failing the American People


From MedPage Today: “Many observers don’t fully appreciate how the FDA has taken a position that is indefensible. The agency does not guarantee that drugs that come to the U.S. market actually help Americans live longer or better lives (beyond what could be achieved without these drugs). At the same time, the FDA insists on interfering in the market and sets arbitrary standards for approval. The combined effect is the worst of all possible worlds: we don’t know if drugs work, and the companies can charge massive prices for them!

. . . What is the American public to think? We have an agency that is happy to approve $100-billion-a-year drugs to a desperate and vulnerable population without knowing that patients are better off. Society pays for those costs — often through Medicare — but that same society won’t pay for a caregiver who might actually ease the burden on families who have a loved one with Alzheimer’s. If drugs approved by accelerated approval later don’t work, experts are happy to continue to keep them on the market, citing anecdotal impressions of their utility. The bar for approval is ridiculously low, but not absent altogether — a fact that facilitates high drug prices. Finally, the people who work at the FDA later go to work predominately for the companies that profit from the FDA’s lax standards. The revolving door spins so fast it might hit you in the rear.

Our system is grievously and horribly broken. I have been following it closely and my worry is that I see no signal it is getting better any time soon.”

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  1. I was an FDA reviewer in the Neurology and Psychiatry Divisions. Nearly a year ago Mad in America published an article in which provided analyses I performed that showed antipsychotics do not work in patients with mania that was not severe, i.e., YMRS scores of <27 where full blown mania results in YMRS scores of 18 or above. ( They did however work in severe cases of mania. Despite knowing this and that knowing these drugs kill people FDA officials Tom Laughren and Ellis Unger approved the drug with Ellis Unger essentially admitting that I was correct but that a drug that did not work and killed people was not a reason for him not to approve it. Something that I believe constitutes deliberate poisoning and mass murder. In addition, I had found that these drugs are killing infants and this has also been deliberately covered up even though women with mania in the range where they are ineffective are hypersexual and where women are advised to take them when pregnant with claims that they are safe.

    Three months ago I published an open petition to President Biden on page A2 of the Washington Post regarding this, that these drugs were killing infants, as well as an illegal approval of a nerve agent for prevention of death by the military nerve agent Soman for US troops. An approval that FDA officials was illegal as the claimed rationale was impossible and would actually result in more US troops being killed and even more importantly as we knew that Saddam Hussein was not using Soman and was instead using nerve agents where studies showed that the drug did in fact increase lethality. (

    For reporting mass murder, infanticide, and possible treason to Congress and the FBI I was fired and was accused of being mentally unstable and violent for reporting felonies, setting me up to be killed by security.

    Among those involved in both of these illegal approvals were acting FDA Commissioner Janet Woodcock.

    If President Biden or Congress had acted and made sure the individuals involved were prosecuted I believe we would not be in the predicament with Aduhelm now. In addition, documents released as part of the Zyprexa papers show that the new head of CDER Patrizia Cavazonni, a psychiatrist, was likely involved in a cover-up of the hyperglycemia with Zyprexa. If so then in my view it demonstrates moral turpitude and she should not be employed by FDA, or drug development in any manner, and that she deserves to lose her medical license.

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  2. I love how this gets so much attention all the sudden when it’s about an Alzheimer’s drug. What about the other desperate and vulnerable populations? Like psych patients. People like me who endured horrible trauma their entire childhood and then got rewarded for surviving that by being laughed at abused labeled drugged incarcerated restrained brain shocked and spit out by the helping system. The FDA has been approving psych drugs for decades and then the patients get blamed when their compliance in taking the drugs leads directly to hell if they’re even given any choice in the matter.
    After decades of poly-drugging and other interference like electric shock I was spit out . Can’t go to a doctor. Can’t get therapy. I just have to survive now. Suddenly the fda’s failures and corruption is front Page News. But nothing about the miracle drugs they approved in the 1990s and forward along with the lie that they cured mental illness because they discovered it was all about a chemical imbalance. Nothing about that and all the lives destroyed in mainstream media.

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