\nJury Hears From Teen Boy’s Doc At Risperdal Trial<\/font><\/u><\/a><\/strong>
Law360<\/font><\/strong>
By Matt Fair
September 28, 2012<\/div>\n<\/p>\n
In a video deposition shown to jurors Friday, the doctor of a teenager claiming he grew breasts after taking the antipsychotic drug Risperdal said that the boy suffered from severe developmental and behavioral problems, and that he was unaware of possible side effects when he prescribed the medication. Vernon Johnson, a physician who treated 17-year-old plaintiff Andrew Bentley, appeared in a video deposition shown to jurors Friday in a case accusing Johnson & Johnson subsidiary Ortho-Janssen-McNeil Pharmaceuticals Inc. of marketing Risperdal for off-label use in children despite the risk of gynecomastia, or abnormal growth of breast tissue.<\/p>\nJohnson testified that Bentley required antipsychotic drugs to treat auditory hallucinations that led to behavioral trouble in school and at home, but that he was largely unaware of the risk of gynecomastia. “He was reporting that his brain was telling him to do mean things,” Johnson said. “He claims he has a voice in his head telling him he has to get even with everyone.” He added, however, that he didn’t know that gynecomastia was a significant risk associated with the drug. “If we had known that was a significant risk, we would’ve warned,” he said…<\/sup><\/div>\n<\/blockquote>\n
Well, I found out a little more. The doctor in the case thought the boy was psychotic and having command hallucinations. I’m not used to hearing that auditory hallucinations are associated with Asbergers\/Autism Spectrum disorders – though "his brain was telling him to do mean things" and "he has a voice in his head telling him he has to get even with everyone" might be referring to his thoughts – but the danger is similar. The thing I didn’t learn from this report was how long he was on the Risperdal. I don’t think we’ve heard that yet, at least I can’t find it.<\/div>\n\nProducts liability trial in Risperdal case opens<\/font><\/strong><\/u><\/a>
Pittsburgh Post-Gazette<\/font><\/strong>
By Gina Passarella
October 1, 2012<\/div>\n<\/p>\n
A lawyer for a boy who allegedly grew breasts from taking Risperdal told a Philadelphia jury last week that Johnson & Johnson illegally marketed the antipsychotic drug to kids as part of a national policy to increase sales to patients beyond the 1 percent of the population who has schizophrenia. While the plaintiffs painted a picture of a national scheme by Johnson & Johnson subsidiary Janssen Pharmaceuticals to market based on dollars instead of science – a practice called "off-label marketing" – Janssen’s attorneys emphasized in their opening statements that this case was about one boy and the decision by his doctor to give him what many view as a "miracle" drug.<\/p>\nOpening statements in A.B. v. Janssen Pharmaceuticals were held in Court of Common Pleas in Philadelphia. The case makes for the first of the 86 cases in the court’s Risperdal mass torts program to open to a jury. There were eight bellwether cases selected by the parties. The 12-member jury and three alternates in A.B. are hearing a case selected by the defense. Four other cases are scheduled for trial in the coming months.<\/p>\n
Attorney Robert Hilliard presented opening statements to the jury on behalf of the plaintiffs, a 17-year-old boy with Asperger’s syndrome, and his mother. "There’s just not enough schizophrenics in the United States for them to make enough money," Mr. Hilliard told the jury. He said that caused Janssen to market the drug to treat kids with schizophrenia, which he said was not FDA-approved at the time, but to treat kids with other problems, such as bipolar disorder or behavioral problems.<\/p>\n
Mr. Hilliard said the evidence would show that at about the same time A.B. was prescribed Risperdal in 2000 for "conduct disorders," Janssen wrote in an internal marketing report that Risperdal increased the hormone prolactin, which typically causes breast enlargement and milk secretion during pregnancy. This in turn can cause gynecomastia in men, the production of mammary glands, Mr. Hilliard said the marketing report detailed. Mr. Hilliard told the jury there were three main issues he would prove at trial:<\/sup><\/div>\n
<\/p>\n
1. The first was Janssen’s drug reps were taught to tell doctors the threat of gynecomastia was a problem caused by all second-generation antipsychotic drugs even though, Mr. Hilliard said, Risperdal was the only one to have such an effect.<\/div>\n<\/sup> <\/sup><\/p>\n
2. The second was that Janssen noted on its Risperdal label that the possibility of gynecomastia was "rare," even though its own tests showed that it occurred "more than frequent[ly]."<\/div>\n<\/sup> <\/sup><\/p>\n
3. The third and biggest issue he said was that in 2006, when Janssen again asked the FDA to approve the marketing of Risperdal for the treatment of children, it provided allegedly false data that suggested gynecomastia was not a side effect. The FDA granted approval based on that data, he said.<\/div>\n<\/sup> <\/sup><\/ul>\n
Laura H. Smith, attorney for Janssen and Johnson & Johnson, said the results of every one of the 18 studies Janssen conducted were turned over to the FDA and were included on the drug’s label after the FDA approved the use of Risperdal for children. Ms. Smith noted several times throughout her opening statements that the FDA approved the drug’s use. She also said the case was not about what the world knew or thought of Risperdal, but about what A.B.’s doctor knew of the drug and whether he would have prescribed A.B.’s medication differently had he known.<\/sup><\/div>\n<\/blockquote>\nAs for the third issue [FDA Approval for irritability with Autism], that 2006 FDA Medical Review is not on the FDA web-site – look though I might. The only thing is the Label<\/em> from the time of the approval [see a keynote address…<\/font><\/strong><\/u><\/a>], but I missed this<\/font><\/strong><\/u><\/a>: <\/div>\n\nEndocrine Disorders<\/font><\/strong><\/u>
Rare<\/font><\/strong>: gynecomastia, male breast pain, antidiuretic hormone disorder.<\/sup><\/div>\n<\/blockquote>\nThat word Rare<\/font><\/strong> may just be part of Janssen’s problem. <\/div>\nMs. Smith, the Janssen lawyer, said that "the case was not about what the world knew or thought of Risperdal, but about what A.B.’s doctor knew of the drug and whether he would have prescribed A.B.’s medication differently had he known.<\/em>" That’s a tempting logic. Sure, it’s hard for an impaired young boy to have gynecomastia added to his list of woes, but if the medication controlled his paranoid thoughts, wasn’t it worth it? Almost every drug has Rare<\/font><\/strong> side effects that some people end up getting. Would the kid have been better off on some other drug? or on no medication at all? Some boys get gynecomastia anyway. Maybe the doctor didn’t read the package insert carefully enough, or pay close enough attention to the case. Anyway, at the time he was started on Risperdal, the drug was only five years old – maybe Janssen just didn’t know yet about gynecomastia.<\/p>\n
Well I don’t think those things apply to this case. It’s about the story Janssen told all of us in that period. For one thing, the whole issue of prolactin elevation was on the table from the very start, and Janssen minimized it, just like they minimized obesity and diabetes. If they’d told us the truth, there would’ve been a lot less Risperdal prescribed – which would’ve been the right thing. But I know that’s not my whole thinking, or why I’ve personally been so invested in the whole Janssen\/Risperdal story. It’s because I’m a doctor – a kind of a nerdy doctor<\/em>, as Ben Goldacre claimed in his TED presentation<\/font><\/strong><\/u><\/a> – I keep up. And like any psychiatrist, I’ve never liked prescribing neuroleptic medications. It’s always a rock and a couple of hard places. The patient is struggling with compelling and often dangerous internal forces, the medications are loaded with potential problems, and there’s no safe alternative. Often, the illness itself precludes a therapeutic alliance. So the choices can be reframed as "All you doctors want to do is give pills!" versus "Didn’t you see how sick he was? how dangerous?" And even when the medications work, you’re soon faced with the problems of long term use.<\/p>\n
So when the atypical antipsychotics came out, they brought the promise of some relief from those binds for doctor and patient alike. It was an eager market. Even if they’d been forthcoming with the true risks of their drugs, we might’ve used them in the psychoses where the risk\/benefit problems with the older neuroleptics have been such a chronic problem. But because Janssen wanted Risperdal to be a blockbuster, they sold it as being not only the wished-for drugs in the psychoses, they said the drug was safe and could be used for lots of things without all the worries of the past – addiction, abuse, bad side effects, etc. Indeed, the atypical antipsychotics became the most profitable drugs in the nation for a while, far exceeding any use by psychiatrists. They still rank pretty high, in spite of going generic. <\/p>\n
Doctors are used to optimistic claims from drug reps or from the glossy mailbox fillers. If you’re a kind of a nerdy doctor<\/em>, you have other places to get the real story: articles in peer reviewed journals, textbooks, academic medical experts [renamed KOLs], [required] Continuing Medical Education. And in 2000, A.B.’s doctor likely still believed in those things, like I did. And in 2000, A.B.’s doctor likely would have chosen an atypical antipsychotic over a first generation antipsychotic or over saying, "Sorry, can’t help." I know I would’ve. And he might likely have chosen Risperdal because of its side effect profile. I expect I would’ve too.<\/p>\n