April 14, 2008

Injectable Antipsychotic For Bipolar Disorder! WTF?

I'm sure some readers are tired of reading my amazement at just how aggressively pharma companies are pushing to have their antipsychotics used for damn near every human psychological flaw between heaven and earth, but here's yet another example of just how far Big Pharma will go. Johnson & Johnson today submitted a new drug application to the FDA to have its Risperdal CONSTA--the two-week injectable version of Risperdal--approved as an adjunctive, or add-on, treatment for rapid cycling bipolar disorder.

In a release, the company claims that what it calls "frequently relapsing bipolar disorder" (aka, rapid cycling) affects 10 percent to 20 percent of people with bipolar disorder--27 million people worldwide, says J&J.

When pushing an injectable, companies usually emphasize treatment non-compliance as justification for use of an injectable, but not so here. And since J&J is seeking approval as an add-on treatment, then it's safe to assume that patients are likely already on some other meds. So I am at a loss to explain what the advantage might be in using an injectable over, say, an antipsychotic in pill form. Not that I am a fan of Risperdal or any other antipsychotic in pill form--these drugs are dangerous used long-term and there is ample evidence of that.

What's also weird here is that a patient with rapid cycling bipolar has likely already been trialed on an antipsychotic, so it's hard to understand how the company plans to market an injectable version of Risperdal for patients for whom pill form Risperdal likely didn't work.

What discouraging to me is that we know that a fair number of cases of rapid cycling can be linked to the use of anti-depressants in treating bipolar disorder and that some leading psych researchers are calling into question the use of anti-depressants in treating bipolar disorder. So you'd hope that a smart doctor would insist that his or her patient get off whatever anti-depressants they are taking first before addressing matters with CONSTA.

Whatever you all make of this new drug application, I continue to be staggered at the push by pharma companies to get antipsychotics embedded into American life.

Posted by Philip Dawdy at April 14, 2008 11:02 AM
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Comments

You know, I think it's just all about gaining approval to remove liability for off-label use. Of course there is more to it than that; but the one way I know for a fact these injectables will be used are inside inpatient psych wards. I've seen far too many wildly manic [women]given anything injectable, to shut them up.

I suppose J&J also will tout "ease of use" for people who don't like to swallow pills in an out patient setting. Though who will inject the patient out patient? Most psychiatrists do not have nurses on duty, would it be from a PCP? That's even scarier.

Posted by: Stephany at April 14, 2008 11:31 AM
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