Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids

The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.

It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J’s promotion of Risperdal for children was misleading.

Attorney General Alleges Jansen Illegally Marketed Antipsychotic Drug – to kids and the elderly

Drug manufacturer Ortho-McNeil-Janssen is being sued by Attorney General Martha Coakley for illegally marketing Risperdal, an atypical antipsychotic medication. The complaint, filed this week in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

DSM 5 Will Further Inflate The ADD Bubble

We are already in the midst of a false epidemic of ADD. Rates in kids that were 3-5% when DSM IV was published in 1994 have now jumped to 10%. In part this came from changes in DSM IV, but most of the inflation was caused by a marketing blitz to practitioners that accompanied new on-patent drugs amplified by new regulations that also allowed direct to consumer advertising to parents and teachers. In a sensible world, DSM 5 would now offer much tighter criteria for ADD and much clearer advice on the steps needed in its differential diagnosis. This would push back ,however feebly, against the skilled and well financed drug company sell. DSM 5 should work hard to improve its text, not play carelessly with the ADD criteria in a way that may unleash a whole set of dreadful unintended consequences- unneeded medication, stigma, lowered expectations, misallocation of resources, and contribution to the illegal secondary market peddling stimulants for recreation or performance enhancement.

The DSM 5 child and adolescent work group has perversely gone just the other way. It proposes to make an already far too easy diagnosis much looser.

How Did These Babies Die? Question unites grieving families

Matthew Schultz was only 2.5 hours old when he died on Feb. 21, 2009. A coroner’s report stated there was no anatomical or toxicological cause of death, which was deemed “natural”. Another baby, Greyson Rawkins, was only two months old when he died on March 23 of this year. A coroner’s report found Greyson died of sudden unexplained death in infancy and his death was ruled undetermined. However, the mothers of both babies were taking Effexor while carrying and believe the antidepressant drug may be connected to the deaths of their children. And, as KTW learned, there are widespread medical warnings about pregnant women taking antidepressants.

Bitter pill for chief of Forest Labs

The government, fed up with Forest’s encouraging doctors to prescribe for children antidepressants approved only for adults, has demanded that Mr. Solomon be sent packing. If the company fails to comply, Washington will effectively bar Medicare and Medicaid from buying its drugs. Such a move “could amount to a corporate death sentence,” according to a memo co-authored by Kenneth Breen, a partner at Paul Hastings, a law firm that has represented Forest in the past.

The company also got in trouble with the Food and Drug Administration, which in a 2003 letter warned Forest to stop marketing an unapproved new drug. Rather than comply immediately, prosecutors said, Forest tried to move as much of the item as possible, going so far as to override computer systems, hire extra trucks and pay staffers overtime at a St. Louis distribution facility before halting shipments a day after receiving the FDA missive.

Forest pleaded guilty last November to obstructing justice, distributing an unapproved drug and distributing a misbranded drug. In addition to agreeing to $313 million in penalties—equal to about a third of earnings in the last fiscal year—Forest signed a Corporate Integrity Agreement with the Department of Health and Human Services’ inspector general.

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