Sunday, December 16, 2012

Should Drug Reps be Mute on Off Label Drug Use?


Am I an apologist for the pharmaceutical companies?  I don’t think so, but others may disagree based on some sympathetic Whistleblower posts that have appeared in this blog.  It is without question that the drug companies have been demonized and portrayed as rapacious gangs of greed who seek profit over all.  Haven’t you come across the pejorative term, Big Pharma?  Linguistical note:  The adjective ‘Big’ means evil. Consider:

Big Oil
Big Government
Big Tobacco

Get the point?


 Big Elephant!

I’m not suggesting that the pharm guys and gals are all Eagle Scouts.  These companies operate to make money, just like car companies, the cosmetic industry, the airlines, banks and financial institutions, hospitals, manufacturers, the hospitality industry and retailers throughout the land. 

Here’s a bold Whistleblower pronouncement.

There is nothing evil about making money.

Of course, I want our drugs to be safe and effective.  We need the Food and Drug Administration (FDA) to provide oversight to protect the public interest.  I acknowledge that the industry needs external review and enforcement powers to keep the industry responsible and accountable.   There’s a reason that professional football games need referees.  Somehow, I don’t think that the honor system on the gridiron would be sufficient.  Players cannot police themselves.

But some of the constraints that drug companies face constitute unnecessary harassment that does not protect the public interest.   Pharmaceutical representatives, or drug reps, are prohibited from discussing ‘off label’ use of their drugs with physicians.  (Off label refers to a medicine being used for a purpose not officially approved by the FDA.) I’ve always felt that this edict was silly and stifled communication between physicians and reps.   Yes, some drug reps have aggressively marketed their products for off label use. GlaxoSmithKline and Johnson & Johnson paid handsomely for committing this offense. 

But, there is a clear difference between misleading promotion and honest communication.  If I question a drug rep about off label indications of a drug, a straightforward response  harms no one.  In fact, it may give me new knowledge that I could use to help a living and breathing patient.  Relax, patients.  I am well aware that pharm reps are sales folks and are not my primary resource for pharmaceutical education.  But good reps have deep knowledge of a very narrow medical issue – their products – and often know stuff that I don’t.   They may, for example, know of side effects of their medicines that are not widely known.

Keep in mind that most of the medicines that we physicians prescribe are off label, which is entirely proper and is acceptable to the FDA.  At present, the only folks in the country who can't discuss off label use of drugs with me are the reps.  

Recently, a federal appeals court set aside the conviction of a drug rep concluding that his marketing a drug for off label use was permissible under the freedom of speech doctrine. This ruling only applies to the region under the jurisdiction of the Second Circuit, but this will not be the last legal word on this issue.   More details appear in the New York Times piece that reported the decision.
 
Where should the line be set here?  I’m not sure, but I think the current FDA boundary is overly restrictive.   We need a dose of leniency and a tincture of common sense from Big FDA.


2 comments:

Andrew Jackson said...

It is difficult to find some sympathy for "Big Pharma" as you put it, however if the reps have information that can be helpful to a physician and are afraid to share this information due to fear of being penalized, then there is a problem somewhere in the system. I think off label promotion by the pharmaceutical companies is not the way to go. As you said about football, players can't police themselves. I do however feel that there should be a relationship with the doctors that would be helpful, and should be able to share knowledge of the product, and if the doctor inquires about off label use of course they should be made aware of every nuance of the product so that the safe administration of said drug can be done in the safest possible manner.

Michael Kirsch, M.D. said...

Andrew, appreciate the comment. Sounds as if we agree that current regulations are overly restrictive. Are you in the medical profession or simply a concerned citizen?

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