Antipsychotic Drug Misuse Lands Johnson & Johnson on the Wrong End of Federal Suit

“In the federal suit, Johnson & Johnson is accused not just of promoting Risperdal for patients without psychosis but of providing kickbacks to Omnicare, a middleman that supplied drugs to nursing homes and advised doctors what to prescribe.  Last fall, Omnicare settled its part of the suit for $98 million.”

The Boston Globe, Monday March 22nd, 2010

It was not that long ago that I began covering the story of how powerful anti psychotic drugs are, in record numbers, being prescribed to children between the ages of 3 and 17.  In 2006 alone, the last year for which statistics are available, anti psychotic drug prescriptions were the largest single expenditure for Medicaid totaling $7.9 billion.

This of course raised many questions including the role that pharmaceutical companies played in terms of encouraging doctors to prescribe these drugs to children.  The revelation of the Johnson & Johnson story may go a long way towards answering that question.

In the case of Risperdal, Johnson and Johnson has earned millions of dollars by selling it as an “off-label” product to treat patients who have dementia but are not psychotic.

For those who may not be familiar with the term off-label, what it simply means is that the Food and Drug Administration has only approved Risperdal for treating schizophrenia and bipolar disorder.  However, through physician trial and error some drugs that have been approved to treat ailment A (FDA approved) are also found to be effective in treating ailment B (non-FDA approved, off-label).  To this point in time however, there has been no physician case references or published materials regarding the effectiveness of Risperdal in treating dementia in senior citizens who did not suffer from psychosis?

In fact, and according to a November 24th, 2009 News Release from the Stanford School of Medicine titled 14 drugs identified as most urgently needing study for off-label use, Stanford professor says, antidepressants and anti psychotics are “the most prominent classes of drugs on the list, which specifically targets drugs that have high levels of off-label use without good scientific backing.”

Add into the equation the fact that a 2005 FDA report found that the use of anti psychotic drugs was directly linked to an increased risk of death amongst the elderly, and one would be hard pressed to understand the logic behind Johnson & Johnson actively promoting the off label product’s use.  Especially given the special FDA warning that was issued regarding the prescription of anti psychotic drugs to seniors.

In the end this goes back to the questions surrounding the historic health care legislation that just passed in terms of increased access over the quality of care.  While 32 million additional people will now be covered over the next decade (which is good), I cannot help but wonder what that will ultimately mean if critical issues such as the abuse of off label products is not dealt with effectively.

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