Antipsychotics have a boxed warning against use in the elderly due to increased mortality.

He’s what I found in the Zyprexa reviews that are on the FDA’s website. The Sept 1996 Zyprexa approval documents reveal that there was a disagreement between Paul Leber the Neuropsych division director and Bob Temple his boss about approval in one of three cohorts (subgroups) that were unidentified.

Nobody's perfect.

After lawsuits were filed about JNJ’s Risperdal (risperidone) causing gynecomastia (breast growth) in men.



I went back to my review of Invega on the FDA website. Invega is the active metabolite (9-hydroxy-risperidone) of Risperdal.law.com/thelegalintell… 9-hydroxy-risperidone aka paliperidone (Invega) has virtually the same receptor activity as risperidone (Risperdal) and after Risperdal is given, paliperidone and risperidone have equal exposures and were believed to contribute equally to effects.

Hampton Dellinger, OSC’s Special Counsel, who’s in charge of gov’t employee whistleblower disclosures was the keynote speaker at Tuesday's National Whistleblower Appreciation Day on Capitol Hill. I attended but was escorted out of the ceremony for whistleblowing about Mr. Dellinger burying WBing disclosures and aiding in (mass) murder.

The #FDA has deliberately covered-up #antipsychotic induced treatment emergent #suicide in patients with mania.

Randomized double-blind placebo-controlled studies of Saphris and Zyprexa for the treatment of manic episode show 0.3% of patients on each drug committed suicide and 0.7% on each experienced suicidality. (i.e. attempted suicide, suicidal thought, self-harm…) that occurred 2-3 weeks after beginning treatment. As compared to no suicides or suicidality (0%) with placebo. (0.3% means a successful suicide in approximately 1 out of every 333 patients treated with an antipsychotic who remains on drug for 2 weeks.)

In contrast, there was no increased risk in schizophrenia patients acutely treated for an acute psychotic episode.

Plus, while there was no indication of an increased risk of suicide or suicidality with long term maintenance therapy for either mania or schizophrenia. The lack of placebo controls means a lack of risk cannot be proven. This signal for antipsychotics inducing suicide in patients treated acutely for mania is much stronger than the evidence for antidepressant induced suicidality for which there is a boxed warning.

Schering nevertheless dismissed this clear signal for an increased risk of treatment emergent suicide in mania. That occurs at 2-3 weeks after beginning therapy when patients were being discharged from the hospital. By inappropriately combining the short and long-term data from both illnesses and inappropriately normalizing the data. With the FDA simply accepting these obvious misleading manipulations.

Similar data normalizations had also been used by drug companies with antidepressant suicidality in teens and adolescents that even lay juries had rejected as inappropriate after it was explained.

After I pointed out the error in what had been done by Schering, the psych division doubled down on it, and dismissed the risk by discussing the short- and long-term schizophrenia data and the long-term mania data where I had said I didn’t see any evidence of an increased risk. While ignoring the short-term mania data where there was a clear signal.

Infanticide

#FDA safety reports show >10,000 infants have been killed by #antipsychotics.

Documents also show Janet Woodcock, Tom Laughren, Bob Temple, & others engaged in racketeering and other criminal acts to make certain infanticide & other deaths would occur in order to protect drug company profits.

The FDA’s cover up of #infanticide with antipsychotics is worse than what occurred with #thalidomide. As infanticide from antipsychotics was warned about, known, & as racketeering and other criminal acts were used to cover it up.

Acts that constitute death penalty crimes for which there is no statute of limitations. 2011 FDA postmarketing safety data showing 6.1% of deaths reported to the FDA with the antipsychotic #Seroquel were in infants less than 2 years old. These children could have only been exposed to Seroquel during pregnancy or from breast feeding.



When data from all antipsychotics was reviewed it was found that ~500 infants were being killed every year.

drive.google.com/file/d/1uMoaUW…
drive.google.com/file/d/1n-K5Mn…

FDA officials have committed mass murder of people with mania with over 32,000 killed so far and ~$40 Billion in fraud and waste paid to drug companies.

#FDA’s Ellis Unger approved the #antipsychotic Saphris for the acute treatment of #mania despite admitting in his approval memo it didn’t work in a subgroup that could be identified in advance & despite knowing it killed people. And despite it also known to be a class effect.

Unger agreed with my analysis that it didn’t work in these people but then Unger used double-talk make a false and misleading claim as to why it didn’t work, when it doesn’t matter why it doesn’t work. He then effectively said that just because it doesn’t work (and kills people), these were not reasons for him to withhold approval.



This is false. The Food Drug and Cosmetic Act (FD&CA) requires non-approval. I suspect that if the company came back in and asked for approval in just those in whom it worked this might be possible. Although regulations require labeling to have a limit of use statement saying it’s not approved for this subgroup, along with the reasons why.

Based on his position and what he does, Unger was required by the FD&CA to know these laws.drive.google.com/file/d/1wm6sbg… Plots of the efficacy of the antipsychotics Saphris® and Zyprexa® for acute manic episodes showed there was no difference from placebo in the ~50% of patients who were less severely ill. (But who still had full blown mania.)

However, they did work quite well in the 50% who were more severely ill. Which included those patients who had psychotic symptoms where antipsychotic drugs were used historically. Although efficacy in the more severely ill patients was not related to whether they were psychotic or not.