In the end, I've decided to simply let it speak for. . . itself. It was an ad, run exactly one week ago today. Here is a PDF of the relevant page. See the ad itself, at below, right.
The allegations are serious, and if they are supported by credible evidence, they at least deserve a public airing. It really shouldn't matter what the time frame was, or which administration it might have occurred under. Here it is, in full, at right.
7 comments:
This is Ron Kavanagh.
Thank you.
I only touch on the three most serious issues which I will discuss in several comments.
The first two deal with a Schering Drug, Saphris, and by extension other antipsychotics.
An Organon VP told me that Fred Hassan bought Organon specifically because of Saphris. I believe if it hadn't been approved the sale would not have been for as much and so less people would have lost their livelihoods.
As for the first issue. Analyses I performed showed that Saphris and Zyprexa did not work in less severely ill patients with mania. In fact my analyses show that about 50% of patients for whom they are approved show absolutely no difference from placebo and the plots of the response over time in these patients are nearly 100% superimposable on the placebo response. In addition I obtained similar findings with all the other antipsychotics I used to check this and then JNJ came in with their own analyses showing the exact same thing. N.B. Info on lack of effect is public. Despite public documentation showing that Ellis Unger the approving official knew that Saphris and other drugs kill people. In his approval memo he agreed with my findings, but said this is not a reason to not approve Saphris. This is a direct violation of the Food Drug and Cosmetics Act which REQUIRED NON-APPROVAL as it was unsafe. Plus it is currently misbranded and is prohibited from being sold as labeling regulations required a limitation of use and a discussion of the data.
As for the second issue. It also involves the Saphris review and by extension other antipsychotics.
A Pfizer whistleblower (Pfizer is the company that did the Saphris development work) told me that there was an issue with 5HT2B effects of the type that cause phen-fen effects. Where it is clear it was not properly studied with either asenapine itself or any of the over 40 metabolites Schering claims.
One the potential consequences of this phen-fen like effect is neonatal deaths due to antipsychotic administration to pregnant and breast feeding women that are likely to be misattributed to SIDS. Such administration to women is common, especially in mania, where there may be pregnancies due to the hypersexuality. This concern was backed up by animal data showing fetal losses as well as post-natal deaths both due to drug administration during pregnancy and from just while breast feeding. With it being worst when drug is given during both.
It was clear the drug metabolism information is the Saphris submission was inadequate and that there was a lack of information, similar to what stopped the approval of thalidomide. In fact there were huge amounts of a number of radioactive materials that could only be metabolites that were dismissed as imaginary because another less sensitive assay method didn't detect them. Therefore we didn't know what they were or the human exposures and so couldn't be sure any of the animal safety studies were adequate. It was even stated by Tom Laughren the psychiatry division director that if I was correct then Saphris could not be approved. Where it's clear that the Food Drug and Cosmetics Act required non-approval.
Laughren then and others then lied (i.e. made false statements that documents demonstrate they knew was false) in order to fire me and not only fire me, but have me illegally removed from the FDA and Saphris review by claiming my whistleblowing were threats of violence. There was then a meeting with Schering where Schering essentially claimed these "major metabolites" did not exist. Which Laughren then used to dismiss the issue.
Prior to this I had told Janet Woodcock about what the Pfizer whistleblower had told me. Then around the same time as the Schering meeting she brought in an outside expert to discuss the 5HT2B issue with antipsychotics, and a person who attended told me they were told "they may not even propose it as a possibility." I later found that this outside expert had published a paper in 2003 showing Abilify has the 5HT2B effect, and that he had called for all new antipsychotics to be screened even earlier.
Due to the potential effect on newborns I had called for the post-marketing data for other antipsychotics to be examined. Which of course was not done. A few years later I found FDA post-marketing data that showed that 6.1% of deaths with Seroquel were in infants as compared to ~24% in the elderly where there's a boxed warning and active off label marketing. Plus there were ~3500 infants deaths total from all antipsychotics combined. A safety issue that the public has never been warned about.
I have other things to do now so I will continue tonight.
By the way at the time. Urs Meyers the foremost pharmacogeneticist in the world was visiting the FDA and attended my Saphris briefing and was shaking his head in agreement with everything I was presented on the drug metabolism. (The 5HT2B issue had not come up yet.) After the briefing he contacted me and we sat down for a couple of hours and smoozed and he told me about increased drug metabolism by a particular enzyme in African-Americans and gave me a paper.
This enzyme is also expressed in the placenta during pregnancy, that along with fetal development caused me to believe this might be a risk for babies exposed during pregnancy. (Even though adults might not have a problem.) And especially African American babies. Plus the FDA had issued warnings of this type of phen-fen effect with antidepressants. Which are often used in combination with antipsychotics, and are also serotonergic drugs. So the FDA knew that black babies might be at particular risk. Consequently they knew they might be poisoning black babies in particular.
The phen-fen like effect with SSRIs has since been downplayed by the FDA due to studies with drug exposure during the 1st trimester, however based on the biology, as well as the studies that showed an effect, as well as based upon neonatal toxicities I saw with other antipsychotics the risk is more likely due to exposures during the 3rd trimester.
Several months after I was removed from the FDA there was an advisory committee meeting regarding approval of antipsychotics in children. In the background materials there were the phen-fen like toxicities that had been reported. Plus two years before I had raised the alarm the post-marketing surveillance group had asked that a warning be put in the labeling of antipsychotics. Which of course has never occurred.
I do not know if the phen-fen like effect is a big problem or not. I don't have enough data to know if the 5HT2B issue I warned about is big enough to be of concern or not. What I do know is that it was not studied adequately and that the Food Drug and Cosmetic Act required non-approval. That I had warned about the possibility of babies being killed. And lastly that we have hard data that babies are indeed dying (although we don't know the cause) and that the FDA knows and has not said anything to the public.
Based on what was known THIS IS WORSE THAN WHAT HAPPENED AT THE FDA WITH THALIDOMIDE.
If you want to see the lack of effect in mania go to the following article
An FDA Whistleblower’s Documents: Commerce, Corruption, and Death by Robert Whitaker at:
https://www.madinamerica.com/2020/08/fda-whistleblowers-documents-commerce-corruption-death/
Then search the page for YMRS score to bring you to right before the evidence.
The third issue deals with military nerve agents and the 2003 Iraq war.
Prior to this war the reversible nerve agent pyridostigmine was approved to prevent death from the military nerve agent soman. It was approved under the animal rule after I had said it would increase deaths which resulted in attempts to get President Bush to waive informed consent for use as an investigational agent. When President Bush refused multiple times it was decided to use the animal rule.
The animal rule allows approval of drugs based on animal data when it's too dangerous to do human trials. Which for pyridostigmine would mean administering soman to volunteers and seeing if fewer people died.
It was claimed that if you administered the reversible nerve agent pyridostigmine it would block the same enzyme as soman blocks (blockade results in death) thereby preventing part of the irreversible blockade. Then after the remaining soman was eliminated the pyridostigmine would then be eliminated, the enzyme would recover, and so would the soldier. Based on the labeling this was proposed to prevent the paralysis and suffocation that causes death in 3-5 minutes.
The problem is that both nerve agents have half lives of over 3 hours and so death would have occurred hours before sufficient drug could be eliminated. (Plus you have an additive effect initially that also has to be overcome.) Consequently based on the kinetics we expected more people to die.
Pyridostigmine appeared to work in monkeys but not in other animals. So there was a big to do to claim that monkeys are more predictive based on nothing, although eventually it was claimed it was due to differences in protein binding but the repeat protein studies didn't support this and just measuring protein in general that this was based on was inadequate to support this hypothesis anyway.
There were a number of other problems, although I'm only going to address two. The first is that it appears that rather than death due to asphyxiation that occurs in 3-5 minute. which by law we were required to base the approval on as that's what the proposed labeling claims it's for, the studies looked at death after 48 hours which appears to mean that a delayed death from a different cause that occurs at a lower dose was being evaluated. This type of delayed death is not an issue if troops are evacuated and given antidotes.
More importantly we knew that after the first gulf war Saddam Hussein was not using soman and was only using other military nerve agents where pyrido either had a neutral effect on lethality or worsened it, where pyrido just increased lethality with one military nerve agent.
you have to take pyrido in advance and we knew Iraq was using these other nerve agents. This meant that based on theory we would expect only increased deaths and based on the animal data and not knowing which nerve agent Iraq was going to use you couldn't be sure if there would be increased deaths or not.
In any event, regardless that none of the animal rule criteria was fulfilled, this meant that under the Food Drug and Cosmetics Act approval was prohibited and any use is likely only to increase the risk of enemies using nerve agents with pyrido causing even more troops to die than would have otherwise.
I was fired for reporting these both to the HHS IG, the FBI, and Congress. Plus I was fired for explicitly indicating that I was exercising my 1st amendment rights to report a discussion I overheard between Bob Temple (director of medical policy and Tom Laughren (psych division director) to rig and advisory committee meeting that place children with ADHD of being horribly maimed or killed.
Doug Throckmorton made the decision to fire me. In doing so he violated several of my statutory due process rights and others. This of course allowed the illegal approval and deaths which in my opinion fulfills a felony that carries the death penalty. Plus he most of the things he fired me for were for reporting felonies. For example in the Saphris review I included a list of possible felonies that I believed had occurred. One I listed was witness tampering and this was for as documented in the Saphris review stating that Dr. Mehul Mehta had told me I could not report felonies by FDA officials without management approval. Which Dr. Mehta then countersigned as true.
However it also covered witness tampering by Janet Woodcock to whom I had reported the medical division falsifying a cause of death. This death was due to anaphylaxis for which it's possible to search on the Saphris review and see exactly who falsified this. Later the FDA had to issue a warning about anaphylaxis with Saphris as it's the worst small molecule in this regards ever.
In addition, there is a whole slew of documents that provide evidence of Janet Woodcock not only being involved in racketeering but also conspiring to violate my Constitutional and civil rights so as to fire me in order to illegally approve Saphris. Where this unlawful approval has resulted in deaths. Something that I believe constitutes a felony that carries the death penalty. 18 USC sec. 241
This is only a v. brief summary but there are numerous documents that back up what I'm saying.
Clarifications: Dr. Throckmorton fired me for the documentation of Dr. Mehta's apparent witness tampering and trying to report it and witness tampering by Janet Woodcock and others.
The reporting of the rigging of the advisory committee meeting was a First Amendment issue because I stated that my own child was at risk as I was about to put him on the drug. Plus based on other things I overheard I believed he had a 1 in 16 chance of being horribly maimed and 1 in 160 chance of being killed due to his genetics. Consequently it was not only whistleblowing and reporting crimes in general but was also a First Amendment petition.
Similar to Janet Woodcock I believe that the evidence clearly shows that Doug Throckmorton committed 1 or more felonies against my Constitutional and civil rights that carry the death penalty.
Overall I believe there is documents that provide proof that over 50 individuals committed felonies many of whom are liable for the death penalty. So there is no statute of limitations.
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