J&J's Risperdal Fed Buyout Hanging Fire On Gynecomastia (Man Boobs)

Fiercepharma has;

WSJ: J&J Federal Risperdal Deal Hung Up On Language Over Breasts

Feds want side effects data in, J&J wants to avoid adding to civil litigation troubles

May 10, 2013 | By Eric Palmer

Johnson & Johnson ($JNJ) has been negotiating terms of a multi-billion dollar settlement over aggressive marketing of its antipsychotic drug Risperdal with federal authorities for at least two years, and now it is hung on talk over breasts, The Wall Street Journal says.

The newspaper, once again citing sources, says the feds want J&J to acknowledge it downplayed data on a side effect that bumped up levels of hormone that stimulates breast development and milk production in women. J&J does not want to include language that might be used in civil lawsuits that make the same claim. The company has already settled cases that claim the drug caused boys to develop breasts but faces dozens more and unknown levels of potential awards. No comments were offered up from either side.

The Risperdal saga has been full of twists and turns, as any long-running investigation tends to be. The feds have been looking into J&J's marketing of the antipsychotic pill since 2004. In the meantime, several of its Big Pharma rivals have inked their own marketing settlements, including Pfizer's ($PFE) $2.3 billion Bextra deal and last year's GlaxoSmithKline ($GSK) $3 billion settlement, which covers off-label and safety-related claims. Last year officials were reportedly ready to settle on a $1 billion payment from J&J, but higher-ups wanted to hold out for more. Since then, The Wall Street Journal has cited sources putting the price at $2.2 billion.


Last summer J&J reached a settlement with 36 states and the District of Columbia over the marketing of Risperdal that topped $180 million. It also has settled a number of civil suits that make the claim about breast development. It hammered out deals on 5 cases last fall, and so managed to avoid testimony from former FDA Commissioner David Kessler. He was slated to testify in one case that he believed J&J's Janssen unit not only violated the Food, Drug, and Cosmetic Act by promoting Risperdal off-label, but that its marketing to children was "most concerning."

- read the WSJ story (sub. req.)

Special Report: Pharma's Top 11 Marketing Settlements
Related Articles:
WSJ: Feds want $1B settlement in J&J Risperdal probe
J&J close to $1.5B-plus Risperdal settlement, but not there yet
J&J aims to block ex-FDA chief's testimony in Risperdal case
J&J to pay states $181M to resolve Risperdal cases

Thank You FiercePharma and Mr Palmer

http://medgadget.com/2007/05/risperdal_legos.html

NOT FUNNY

Risperdal’s Lego’s

by GENE OSTROVSKY on May 25, 2007 • 1:23 am

Promotional materials for Risperdal (risperidone), an atypical antipsychotic medication, is drawing ire from some in the medical blogosphere.

Kevin, M.D.: ” a new low, drug marketing on children’s toys.”Pharmalot: “Keep in mind that, as of last October, Risperdal is approved for kids showing autistic symptoms. So perhaps we should expect to see all manner of playthings with the drug’s brand name. How about a ‘Doctor Barbie’ with Risperdal samples?”Medgadget: “Drugs are booooring… We do like the Legos though.”

Risperidone		Reported By
Adverse Reaction	Cases	MD	CN	OT	PH	LW	NR
Suicidal Ideations	142	86	63	51	3	2	10
Attempted Suicides	248	248	25	53	17	6	11
Completed Suicides	107	84	12	37	9	4	4
Deaths Not From Suicide	900	788	135	357	75	48	33
Homicidal Ideations	16	16	2	14	0	0	0
Homicides	14	14	3	1	2	1	1
Hypomania/Mania	31	18	8	9	0	0	5
Heart Disease	318	262	37	90	44	8	18
Movement Disorders	964	535	226	355	132	37	76
Birth Defects	50	37	3	24	6	0	3
Premature Births	11	9	0	6	0	0	0
Prenatal/Neonatal Deaths	45	34	12	22	4	0	0

94% Of Drug Adverse Reactions Are Never Reported To Govt Regulators: Study

"Contains no active drug."

Why would the Docs the sales bling/popcorn was handed out to need to be told the popcorn contains no active drug?

Isn't Risperdal supposed to induce 'Mental Health'? That IS what it's sold for. Wouldn't the Docs pushing this drug want to be 'Mentally Healthy" themselves, or do you think, Just Maybe, they know Damn Well Better than to Ingest the stuff themselves?


And the Federal buy out/parking ticket is hanging up.

Legos and Popcorn.