Furious Seasons

March 09, 2009

Ex-Employees Claim J&J Off-Label Marketed Risperdal

Among the many lawsuits floating around against makers of atypical antipsychotics is one brought against J&J/Janssen by former company sales reps, alleging that they were retaliated against for complaining about allegedly being pressed by the company to market Risperdal off-label for a host of conditions other than its then-approved use in schizophrenia. among other conditions, they allege that the company off-label marketed the drug for bipolar disorder well in advance of its approval for acute mania in 2003, for example.

From Bloomberg:

"J&J tried to promote Risperdal for conditions beyond schizophrenia, its approved use until December 2003, according to sworn statements among almost 1,000 pages of documents in the case in Trenton, New Jersey. To boost sales of the medicine, J&J urged doctors to prescribe Risperdal for conditions such as bipolar disorder and depression, the declarations say.
"'We (sales representatives) were directed to grow share in these off-label populations,' ex-saleswoman Kristel Kellner said in a statement as part of the lawsuit filed by Lynn Powell, one of the former salespeople. Powell claims J&J fired her in 2004 for complaining about such practices, violating a law shielding workers from retaliation."

This news pisses me off for two reasons. One, I was given Risperdal in December 2000, when a psychiatrist in Portland gave it to me for agitation (likely a result of the Wellbutrin/Depakote combo I was on) and depression. I was an unquestioning patient in those days and I never thought to be bothered by the rapid weight gain and frozen facial features I experienced until two years later. I just figured patients were supposed to put up with side effects.

Two, Bloomberg quotes Columbia University's Jeffrey Lieberman as defending this sort of off-label use.

"While drugmakers aren’t allowed to urge off-label uses, doctors can prescribe medicines for conditions not approved by the FDA. Dr. Jeffrey Lieberman of Columbia University Medical Center said off-label prescribing “is done all the time in the practice of medicine in a very rational and useful way.
"'Researchers are pushing the boundaries of trying to determine how a therapeutic agent can be effectively applied,' said Lieberman, the psychiatry department chairman. 'The process of getting FDA approval is a lengthy, complicated and expensive one.'"

It's lengthy and complicated for a reason, Lieberman, minimal proofs of patient safety and efficacy being part of the picture. I'm not convinced that the off-label marketing we've seen with the atypicals, often shepherded by allegedly independent academics, was safe or efficacious or that psychiatrists prescribed these drugs appropriately.

Interestingly, Lieberman was on of the authors of the recent AJP editorial on how the journal's editors have suddenly declared conflict of interest important. I wonder how much conflict of interest there was among academics pushing Risperdal for off-label uses. I wonder if Lieberman was one of the conflicted ones.

It's even stranger that Lieberman would be defending this kind of horse shit in 2009, when in 2005 he was the lead author of the CATIE studying, establishing that the atypicals didn't work well in treating schizophrenia and were downright dangerous in terms of the metabolic syndrome they created in patients. And in a 2007 interview, Lieberman damn near declared the death of the atypicals. So his views in the context of the off-label marketing of Risperdal make little sense and infuriates the hell out of me.

Posted by Philip Dawdy at March 9, 2009 12:03 AM

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Comments

good for you Philip for posting this, and good for you for using a lot of my old news room lately in your blog.

Posted by: susan at March 9, 2009 01:56 AM

I was given Risperdal when I was 14 back around January 2002 or so, when I was in eighth grade for generalized anxiety disorder. That psychiatrist claimed that I needed the drug and pushed it onto me. I was in eighth grade, in middle school and was put on this awful antipsychotic for off label use. This makes me so mad. I'm more mad at the psychiatrist who aggressively pushed it onto a 14 year old with anxiety. These psychiatrists give out antipsychoitcs to teenagers, pre-teens and adolescents for way off label uses. They suck.

Posted by: Princess at March 9, 2009 07:10 AM

I was put on Risperdal for "bipolar maintenance" the year it came out...

what's more it caused akithisia and my doc kept saying the akathisia was my underlying disorder so he kept on increasing the Risperdal dose to treat the condition it was causing!! And I reached a high of 11 mg! Not until I got off of it did it become clear he was giving it to me to treat it's own side effect....sickening.

Jesus, if I had known what I know now...how things might have been different...

also Risperdal in combination with depakote caused me to gain approx 100lbs...40 lbs of that are gone now...unfortunately it's because I'm generally to sick to eat...from the withdrawal process...

glad to be off all that shit now but I've got a ways to go for my body to heal.

Posted by: Gianna at March 9, 2009 07:11 AM

Risperdal has been implicated in causing more violence among psychiatric inpatients.

The following article has a list at the end which shows the number of patients receiving atypical antipsychotics at Western State Hospital in Washington.

Risperdal was given three times as often as other antipsychotics, both atypical & typical.

Also, the SSRI Zoloft was one of the top drugs but, still, Risperdal was given over three times as often as Zoloft.

Here is the article [partial] from SSRIstories.com
To read the full article go to:
http://www.ssristories.com/show.php?item=1803

Paragraph 1 reads: "Violence has been a growing problem at Western State Hospital for years."

Paragraphs 3 through 5 read: "For years, hospital administrators have blamed the violence on familiar causes: not enough staff members, not enough money and increased societal violence that leads to the admission of more-violent patients. But they don’t have the data to back up those assertions."

"A News Tribune analysis of drug-prescribing trends at Western since 1999 finds another possible factor: Western is giving more patients psychiatric drugs with side effects that can include extreme agitation and aggression."

"The drugs include newer antidepressants and newer anti-psychotics dubbed atypical anti-psychotics."

http://www.thenewstribune.com/news/local/story/72700.html

Drugs might breed violence

Attacks on staff rise at Western State Hospital

M. ALEXANDER OTTO; The News Tribune
Published: May 28th, 2007 01:00 AM

Violence has been a growing problem at Western State Hospital for years.

If present trends continue, one in four of the Lakewood mental hospital’s more than 1,700 workers can expect to be assaulted by a patient in 2007, according to the state Department of Labor and Industries.

For years, hospital administrators have blamed the violence on familiar causes: not enough staff members, not enough money and increased societal violence that leads to the admission of more-violent patients. But they don’t have the data to back up those assertions.

A News Tribune analysis of drug-prescribing trends at Western since 1999 finds another possible factor: Western is giving more patients psychiatric drugs with side effects that can include extreme agitation and aggression.

The drugs include newer antidepressants and newer anti-psychotics dubbed atypical anti-psychotics.

The newer drugs, which are expensive compared with older, generic alternatives, have been heavily promoted at the hospital by the pharmaceutical companies that make them. Sales representatives for those companies have logged about 1,200 visits to Western since late 2003, when administrators began tracking their activity.

Concerned about their influence on prescribing patterns, the hospital in March banned all drug company representatives from visiting the campus to meet with doctors.

Randy Burkholder, an associate vice president for Pharmaceutical Research and Manufacturers of America, the Washington, D.C.-based drug industry lobby group, acknowledged The News Tribune analysis, saying it’s a “great idea” to discover more about the impact of pharmaceuticals through original investigation.

Posted by: Rosie at March 9, 2009 10:18 AM

So we have two more atypicals to go? And no Medguide or black box warning except for seniors with dementia?

As I've said before, I am eternally grateful for the SSRI black box except for the consequences - like a thundering herd, the docs have moved everyone over to the atypicals - for anything, anytime. Better living through chemistry.

Posted by: anonymous at March 9, 2009 02:07 PM