Risperdal (an antipsychotic/neuroleptic drug) is unsafe for use in children, causing diabetes, male breast growth, obesity, brain shrinkage, and other alarming ill effects. Support attorney Stephen Sheller’s petition to the FDA to revoke approval of its use in children by commenting on the FDA’s website!
Stephen Sheller, an attorney representing hundreds of children suing Johnson & Johnson for Risperdal-related adverse effects (including male breast growth and lactation), has submitted a citizen’s petition to the FDA demanding that it “immediately revoke the pediatric indication for Risperdal, all generic versions of risperidone, and Invega (an extended release and injectable medication which includes the same primary active metabolite as Risperdal) unless and until the long-term safety of the drug can be demonstrated.”
Sheller’s legal work has given him access to J&J internal documents and testimony/depositions from top J&J officials that he says support his petition to revoke approval for the pediatric use of Risperdal. This includes a deposition in which J&J CEO Alex Gorsky states under oath that J&J’s demand to paid researcher Dr. Joseph Biederman that he “provide further support for the chronic use of RISPERDAL from childhood through adulthood” was a “reasonable research objective.”
The petition comes as the climax to years of mounting legal pressure and public outcry over the off-label marketing of Risperdal for unapproved uses in children and the elderly, fraudulent clinical trials of Risperdal in pediatric populations (involving Dr. Joseph Biederman of Harvard University) and massive Medicaid fraud. Litigation surrounding these and other issues has resulted in J&J agreeing to pay well over $2.2 billion in fines, and many suits are still being settled.
Meanwhile, an overwhelming amount of scientific research has unequivocally demonstrated the numerous ill effects of the use of Risperdal in children. One study found that after only six months of treatment with Risperdal, 43% of youth experienced extreme weight gain (at least 7% of their weight before taking the medication). Another showed that children treated with antipsychotics are at significantly higher risk for developing type 2 diabetes, obesity, and heart conditions — 25% of the children taking antipsychotics developed at least one of these conditions during the course of the study (about a decade). Antipsychotics have also been shown to cause brain shrinkage and to significantly worsen symptoms of psychosis over time, making a potentially one-time occurrence into a chronic disease.
The FDA’s own Pediatric Advisory Committee acknowledged these and other findings in 2008 when it agreed unanimously that the Risperdal required “more than the standard safety monitoring” and that “metabolic syndrome, growth, sexual maturation, and hyperprolactenmia” were all areas of concern.
Click “Comment Now!” to let the FDA know Risperdal is NOT SAFE for children!
Incriminating Evidence
Several internal J&J Risperdal documents have come to light as a result of recent litigation. Many have been kept private as part of the out-of-court settlements brokered by J&J, but a few have become public. Here are excerpts from two such documents, showing that J&J (a) purchased the expert opinions of researchers like Dr. Joseph Biederman to aid in its off-label marketing of Risperdal to children (b) intended to create lifelong customers of Risperdal — from childhood into adulthood.
(A research center that presented that was charged by their funders (J&J) to produce specific research outcomes that would support the commercial goals of the company. This a report from the Center to its funders on their progress towards these goals.)
“An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.
Considering that nearly all psychiatric medication use in children is off label, studies of safety and efficacy in children are essential for clinicians, parents, and patients to feel comfortable using these medications in children… Equally important to effective use of medications is the demonstration of the validity of disorders. Because parents, patients, and clinicians are exposed to a media that frequently questions the validity of childhood disorders, genetic and brain imaging studies are needed to show the validity of these disorders as brain disorders that respond to medication. Epidemiologic studies are needed to show that childhood disorders are frequently chronic and severely debilitating. Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….
Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:
We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology. This work is an essential precursor to the … widespread use of medications given that most must be used off-label.”
From the full deposition of Alex Gorsky
(Current CEO of Johnson & Johnson (makers of RISPERDAL), recorded in May, 2012 as part of the national RISPERDAL litigation.)
1. Scientific “research” to further Johnson & Johnson’s commercial aims
Q. You see this document is called “Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital“?… And the director is Joseph Biederman, M.D., whom we’ve spoken about a couple times today, right?A. Yes.
Q. Let’s turn to page 861, please, Mr. Gorsky, which is it is executive summary of the annual report. The first sentence of the overview says that “The mission of the Center is…a strategic collaboration between Johnson & Johnson and the Pediatric Psychopharmacology Research Program at the Massachusetts General Hospital.” Is that correct?
A. Yes, that’s what it says.
[…]
Q. Let’s turn to the next paragraph, Mr. Gorsky. It says, “An essential feature of the Center is its ability to conduct research satisfying three criteria. . .” Did I read that right?A. Yes.
Q. And if we look at the third criteria, it says “it will move forward the commercial goals of J&J.” Is that correct?
A. […] Yes.
Q. So, this annual report from the Johnson & Johnson Center For Pediatric Psychopathology from 2002 admits that information and research from this supposedly unbiased research center is to benefit the business of sales for Johnson & Johnson. Is that correct? … And commercial goals would include sales of pharmaceuticals. Is that right?
A. Yes, it would.
2. Promoting the widespread use of medication, specifically RISPERDAL, in children
Q. Okay. And then if we look at the next sentence from the annual report, it says “We strongly believe that the Center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.” Did I read that correctly?
A. Yes, you did.
Q. So…one of the goals of this center’s inquiry is to lead to the more widespread use of medications in children. Is that right?
A. […extensive verbage from Gorsky, followed by…] yes.
Q. … Mr. Gorsky, let’s look at the next sentence, where it says “Considering that nearly all psychiatric medication use in children is off label. . .”
Q. Do you see that?
A. Yes, I do.
Q. And that would include Risperdal because in 2002, I think we’ve already agreed, Risperdal was not approved for use in children and adolescents. Is that right?
A. Based upon our earlier conversation, it did not have the specific indication at that time, that’s correct.
[…]
3. Producing lifelong RISPERDAL customers
Q. And it [the J&J Research Center’s 2002 Annual Report] says — and this is interesting — “Showing how pediatric mania evolves into what some have called mixed or atypical mania in adulthood will provide further support for the chronic use of RISPERDAL from childhood through adulthood.”Do you see that?
A. Yes, I do.
Q. So, one of the specific goals of the center is to show that pediatric mania will evolve into mania in adulthood, which will then require the chronic use of Risperdal from childhood to adulthood. Is that right?
A. […] I think if that was the goal as outlined, that was a reasonable research objective.
[…]
Q. And the continuation of Risperdal from childhood to adulthood would be one of those –remember back in the beginning of this document we saw the word there were commercial goals of Johnson & Johnson, right?
A. Yes, I did see that.
Q. All right. And the continuation of a Risperdal prescription from a young man or young boy through adulthood would be a commercial goal of Risperdal, right? Or of Johnson & Johnson, I’m sorry.
A. Successful treatment of patients, if they were responsive on the medication, for them to stay compliant on the medication would be one of our goals, but only if the drug was working and the patient was living better.
Q. So, the way I interpret this is that Johnson & Johnson and Massachusetts General Hospital and Dr. Biederman are collaborating to validate a lifetime use and treatment with Risperdal. Is that correct?
A.[…]
Links to More Information
- A dossier put together by the New York Times on the scandalous behavior of the J&J-funded researcher Dr. Joseph Biederman