Let’s All Support Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal

Jim Gottstein, JD
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Thanks to Ginger Breggin for posting about Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal on her Facebook Page.  Many of you know that Mr. Sheller recently settled a case against Johnson & Johnson (J&J) over Risperdal causing breasts to grow in a young boy, known as gynecomastia (J&J Settles Risperdal Lawsuit on Opening Day) for an undisclosed sum.   What is not yet well-known is that on July 27, 2012, Mr. Sheller filed what is known as a “citizen’s petition” to revoke the approval of Risperdal (risperidone), and its cousin Invega, for use on children and youth.

This is potentially a far more important event in the struggle to stop the massive psychiatric drugging of children than the individual lawsuits over gynecomastia, as important as they are.  And you have a chance to support this effort.  The petition has been assigned Docket No. FDA-2012-P-0857, and people can file formal comments.  The Petition is there, but it is not exactly a user-friendly site, so PsychRights has posted it here.  A couple of years ago the huge number of electroshock victims who commented against reclassifying electroshock machines as having no or low risk (and also those who came to testify) had a big impact.   I urge everyone to support Mr. Sheller’s petition by submitting comments.  You can put comments right in the text box or upload a more substantial submission.

The Petition is a study in how the pharmaceutical companies game the system.  For example, Mr. Sheller describes how J&J hides, glosses over and understates the harm caused by Risperdal.  Since he is representing boys who grew breasts, sometimes even lactating (galactorrhea), he is most familiar with that and points out that the real world rate of gynecomastia is 5%, not the 2.3% in the prescribing information (Label) and that even this and information and information on it causing women of reproductive age to stop menstrating (amennorhea),

infertility in girls; galactorrhea, gynecomastia and diminished libido in boys; and adverse impact on sexual maturation in children of both genders, are buried in the “USE IN SPECIAL POPULATIONS” section of the Prescribing Information, have given physicians and the public a false sense of the safety of Risperdal® for adolescents and concealed the epidemic of prolactin-related adverse events being inflicted upon children by Risperdal.

The petition also describes other serious harms caused by Risperdal, including diabetes and other metabolic problems.

The Petition also notes that three and a half years ago the FDA’s own advisory panel unanimously concluded the Risperdal Label was inadequate and the FDA should order it be changed to more adequately describe its harms and that the FDA has done nothing to protect the public from misinformation in the Label.

Mr. Sheller further notes that 25% of Risperdal’s use is in children and youth, and

Petitioner’s own investigation has revealed that, historically and notoriously, J&J aggressively marketed RISPERDAL® for off-label uses within the pediatric population and took certain steps to affirmatively mislead the medical community and the public at large about the safety of RISPERDAL® for any duration of use.

Very intriguing is Mr. Sheller’s revelation that as an attorney for boys damaged by Risperdal he has been privy to secret information far worse than publicly disclosed, but as part of the settlement, J&J required the documents remain secret.  Because a lawyer is required to have undivided loyalty to his or her client, when in such a position, the lawyer almost always has to recommend agreement when the other terms (mainly the money) is satisfactory.  In other words, is it proper for the lawyer to advise his victim client to refuse to get compensated because the drug company insists on keeping the documents secret?  Of course, they could insist on going to trial and maybe be able to make the documents public that way, but this carries the big risk of losing.  However, Mr. Sheller points out that while he is not allowed to provide the FDA (and presumably the public) the documents, J&J can certainly voluntarily provide it.

While one can understand why the lawyers agree to keep the documents secret, it is quite troubling that the courts allow themselves to be used in this way to aid and abet drug companies hiding such important documents demonstrating great harm to the public.

This was precisely the situation when I subpoenaed the Zyprexa Papers almost 6 years ago and  released them to the New York Times and others to get them made public, resulting in a series of front page stories in The New York Times about Eli Lilly hiding information about Zyprexa causing diabetes and other metabolic problems and its illegal “off-label” marketing to use it on children and the elderly.  In my view, this situation is crying out for someone to subpoena Mr. Sheller and make Johnson and Johnson explain why this information should be kept from the public.   The states should do this.

For right now, what everyone can and should do is submit comments supporting Mr. Sheller’s Petition to Revoke the Pediatric Approval of Risperdal, and spread the word through all available means.

8 COMMENTS

  1. I’ll say it again just because I feel that I have too. I am upset at how such a relatively minor “side effect” gets all the attention and can get the public more round up than the truly tortuous “side effects” like tardive dyskenisia, dystonia and akathisia. These have been known consequences of neuroleptic drugs for generations and when a kid starts jerking around smacking themselves in the face while drooling and groaning, everyone just says “he has tics.”

    Yep. Tics. That’s what they call that now. There’s no outrage. There’s no lawsuits. There’s no public discussion. Nothing. Involuntary movement disorders are just tics, akathisia is just anxiety and neither of them are really a big deal at all. But if a boy grows some breasts which can be easily removed via surgery, oh that’s an outrage, what a poor boy. Boohoohoo /sarcasm.

    • Absolutely, JeffreyC!

      … I think one of the factors involved here is that the dystonias and akathisia produced by these drugs have become associated with patients’ (real or merely purported) “mental illness” to such an extent that people think “well, smacking yourself in the face is pretty normal for a crazy person…”

      But… breasts on an adolescent boy? No, that simply CANNOT be the result of a “mental disorder”!

      And men and boys are generally horrified by the phenomenon, so accordingly, they receive sympathy for this (relatively minor) suffering.

      Of course, as a trans woman, I find it deeply ironic that if a boy grows some breasts, they “can be easily removed via surgery”, while with about a dozen diagnoses of Gender Identity Disorder, it will still be a major challenge for me to obtain the surgeries required for gender transition – even though my current therapist (a gender specialist) will support surgery for me?

      … but it’s even more ironic that the akathisia and dyskinesias I suffered during the period I was on Risperdal were PURE HELL, and that the intense discomfort these induce were largely ignored by my treating clinicians… while gynecomastia, which may cause some physical and severe social discomfort, is regarded as an horrific condition?

      After all, my only medication now is Spironolactone, and I am overjoyed that I’ve got one of its well-known “side-effects” … gynecomastia. 😉

      … thanks,
      – bonzie anne

    • Ok JeffreyC…so although my child had many problems I can say the “breasts” affected him the most. He was teased so severely in school about it that he was hospitalized for wanting to kill himself and diagnosed as severe depression and has been in therapy for many many years. Way before we knew risperdal was the cause…js.

  3. “In my view, this situation is crying out for someone to subpoena Mr. Sheller and make Johnson and Johnson explain why this information should be kept from the public.”

    I agree, Jim. Moreover, the information should be required to be public. It is, after all, a public health and interest issue.

  4. Risperdal (risperidone) is metabolised by cytochrome P450 2D6, known as 2D6. 5-14% of Caucasians have none (defective genes) and up to 40% of central Europeans have one inactive allele to of two so have a diminished rate of metabolism,. All drugs used in psychiatry are metabolized by this system and all patient are different, see any site explaining psychiatric pharmacogenomics.
    Furthermore CYP450 2D6 is present at a very low level in young people until their early 20s, so they behave like poor metabolisers (phenotype poor metabolisers) of Risperidal (risperidone). Levels in blood rise and produce toxicity, characteristically akathisia, (50 full text papers on Google scholar) with suicidal and aggressive thoughts and behaviours and toxic hallucinations follow and are inevitable. Toxic side effects are poorly recognized by my psychiatrist colleagues who do not know the difference between toxidromes and mental illnesses.
    This is why SSRIs and Zyprexa are such a disaster in kids, and as well their UGTs, (stage 2 metabolism) do not cut in until later, 18 for some. We have published some of this http://www.dovepress.com/antidepressant-induced-akathisia-related-homicides-associated-with-dim-peer-reviewed-article-PGPM We have a paper nearly ready concerning 100 individuals who had no mental illness in existence until they used street drugs or got antidepressants for normal human events, and reacted with toxic side effects. Gene testing for the CYP450s showed they could not metabolize either so instead of getting a safe and slow withdrawal, they got more of the hair of the dog, more drugs metabolized by very enzymes that their adverse reaction showed they could not produce, and most have never left mental health care.
    If anyone is interested in pursuing this information please contact me as I have the backing scientific papers.

  5. Hi Faith. I was thinking the very same thing today. Why dont an international coalition of human rights lawyers get together and ( for example, what i thought today) get a British or Irish lawyer to file a complaint against J&J which may then make the information available publicly via a foreign lawsuit. Might be worth thinking about?