Tuesday, December 4, 2012

Off Label Drug Use Promotion by Pharma Reps Allowed by Courts

Majia here: I believe this ruling is a set back for public health. 

The article uses Risperdal as an example of a drug that has been promoted extensively for off-label use by pharmaceutical companies, especially for children.

I know about Risperdal because I've had several doctors push it for management of my son's behavioral issues that stemmed from his Asperger's syndrome.

I researched the drug and found that it was very dangerous. Within 1 year the average kid who is on Risperdal gains 20 pounds. It disrupts blood sugar levels. A friend whose daughter was put on it for "anxiety" started lactating and gained substantial weight. It also is very sedating.

I found it unbelievable that pediatricians and psychiatrists were promoting use of this dangerous drug to manage symptoms that could be addressed through a variety of "safer" medications and/or behavioral interventions.

I am proud to say that I resisted all efforts to put my son on dangerous anti-psychotics and today he is a very well behaved and accomplished honors student in high school who scores extraordinarily high in math and science standardized tests, runs track and cross-country, and participates in a wide array of activities including tae-kwon-do, Veterans' Heritage, and math club.

The efforts of his teachers and family were sufficient to overcome his anxiety and behavior issues, despite the strong recommendations by physicians to put him on dangerous drugs.

Off-label marketing by pharmaceutical reps exacerbates risks for patients. That is the basic fact and few physicians bother to tell patients the full range of drug symptoms. It is particularly disturbing when powerful drugs for adults are being pushed on kids.

I regard this ruling as a tremendous set-back in patient safety. Pharmaceutical companies should not be allowed to promote drugs for conditions without clinical trials establishing risks and benefits:     

Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses Katie Thomas Published: December 3, 201 The New York Times http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?nl=todaysheadlines&emc=edit_th_20121204

[Excerpted] In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech. 

The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.

In July, for example, the British drug maker GlaxoSmithKline agreed to pay $3 billion in fines, in part for promoting antidepressants and other drugs for unapproved uses; a month later, Johnson & Johnson announced that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug....

The lone dissenting judge, Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”

[end excerpt]

 

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