Saturday, September 18, 2021

Comments by Ron Kavanagh

Showing 5 of 5 comments.

  • What is being proposed is a small but important tweak to what currently occurs.

    Presently, these things are typically discussed at an end of phase II meeting. Plus there may be special protocol assessments.

    Any agreements regarding the trials must be reduced to writing, included in the approval package released by the FDA and may only be changed with regards to the size or design of the trial but not other aspects by the division director and only if justified.

    One thing that is understood and is included in the law on accelerated approval is that the any differences must be “clinically meaningful”. In other words a statistically significant improvement is not good enough for you can always get a statistically significant improvement if you enroll enough people but that doesn’t mean it means anything.

    Examples of this are with depression where in the past changes in the HAM-D not only had to be statistically different from placebo but also had to reach a value of 12 and be a 50% decrease from baseline.

    For mania this would be a difference of 4 on the YMRS, a difference of 2 simply isn’t good enough to make a practical difference.

    So even though these were kind of understood in the past and were done much of the time, I see no problem in making it a requirement. To avoid the times where there’s a problem, e.g. Aduhelm and Exondys 51.

  • 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. (https://www.madinamerica.com/2020/08/fda-whistleblowers-documents-commerce-corruption-death/) 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. (https://truthout.org/articles/as-fighting-intensifies-in-iraq-fda-whistleblower-says-army-s-anti-nerve-gas-pills-won-t-work/)

    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.

  • Mikaika,

    Things can always seem dark. We have to have hope and persevere. Even if there are changes that come about because of this eventually they will be forgotten and chipped away at. We can see that with so many other things.

    Just because you haven’t seen results yet does not mean we should give up. In fact I was just contacted by Congress they didn’t tell me anything but normally I never hear anything and so I have believe that the people who have written Congress are making a difference. What we are need are more people to say things and to petition their representatives and to tell others and to not let this die on the vine.

    For as John Philpot Curran said “The condition upon which God hath given liberty to man is eternal vigilance.”

    When I decided to whistleblow I thought of the admonition by Hillel:

    “If I’m not for myself, then who will be for me.
    If I am only for myself, what I am I.
    If not now, when?”

    These issues and the larger issues with the corruption in the FDA endangered my own life and my child’s and so I needed to protect us. I could have just avoided certain drugs but there were so many that I hadn’t worked on and so knew I had no clue as to what had been covered up. Plus what about everyone else. I couldn’t protect ourselves and not others. There are so many acts of corruption that occur in the FDA but people will often just not listen and so often times it’s the better part of valor to try to do what you can internally to fight knowing that you will fail and be overridden. So most of the time I felt it wasn’t worth falling on my sword over things. However in the face of I what I saw as mass murder I felt that if I wasn’t willing to stand up and risk everything then when would I ever stand up.

    Similarly with all the corruption that I saw in the FDA in the 2000’s and especially with psychiatry (both inside and outside the FDA) it made me think of the famous saying by Martin Niemöller regarding the Holocaust where there are various versions but where I was especially aware of the one where he said:

    “First they came for the socialists, and I did not speak out—because I was not a socialist.
    Then they came for the incurables (i.e. mentally ill), and I did not speak out— because I was not an incurable.
    Then they came for the Jews, and I did not speak out—because I was not a Jew.
    Then they came for me—and there was no one left to speak for me.”

    Consequently I believed that what I was seeing was just the canary in the coal mine and that government attacks on citizens could grow worse.

    So please everyone, please continue to write and don’t let up. Write Congress. Write newspapers with op-ed pieces. Don’t let up. It’s draining and I know it appears hopeless at times and it’s going to be a never ending battle to have integrity in the system but we can’t give up.

  • I appreciate the comments but have to ask readers, so what are you going to do about it.

    The article in my view really doesn’t communicate the seriousness of this.

    I suggest people read the actual whistleblowing disclosures that are linked to in the article. One at the front under “members of Congress” and one near the end under “Congressman Jamie Raskin”.

    The disclosures noted that I reported this as murder to the FBI and elsewhere including in the latest disclosures. (Under Federal law murder is the unlawful killing of someone with malice aforethought and any murder by poisoning is murder in the first degree. Federal jury instructions include depraved indifference to the consequences as fulfilling the criteria for malice aforethought and as the most highly trained clinical pharmacologist at the FDA with the FDA having the largest concentration of clinical pharmacologists in the world it is my professional opinion that causing people to take a drug (where FDA officials admit it doesn’t work and where it’s also documented that they know it will kill people) is poisoning. In addition the FBI uniform crime reports includes poisoning by prescription medications as a method of murder that they track. Plus mass murder is defined as four or more murders as a result of a single act without a cooling off period which signing documents used for approval seems to me to be a single act.

    I literally put my life on the line knowing full well what the likely outcomes might be in order to protect people who might take these drugs. Yet if people don’t do something to protect their own lives like start calling Raskin, Grassley, and their own representatives including President Trump and insist they do something. As well as call other news outlets such as the Washington Post, Foxnews etc. and ask why they aren’t reporting on it. Then this article is a failure and you shouldn’t expect anything different in the face of the pharmaceutical industry paying politicians $300 million per year since 1998. For that’s what your lives are worth, less than a dollar a piece. Not to mention all the advertising dollars, payments to physicians etc.