Tuesday, December 11, 2012

Is Marketing Drugs for Non-FDA Approved Uses Free Speech?

A recent ruling by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan threatens to legalize the marketing of snake oil without any restrictions. It maintains that the marketing  of pharmaceuticals by drug companies for conditions for which the FDA has not approved them is free speech!

Considering the ruling of the Supreme Court in the Citizens United case, many of us are highly concerned that if the lower court ruling is appealed and ends up there, that the current court will concur, and this will become the law of the land.

U.S. Supreme Court

As my colleague Ken Harvey says, only in America.

I have posted here several times about the huge fines levied against big Pharma drug companies for marketing psychiatric and other medical drugs for uses in conditions for which the FDA has not approved them as safe and effective. For a summary, see my last post on the subject.

Once a medication is FDA-approved for any indication, doctors are absolutely free to prescribed it for any other condition they see fit, but pharmaceutical companies are not allowed to market the drugs for these other conditions. This is important because pharmaceutical companies can run poorly-constructed studies that show that a drug might help this or that condition, and if there were no law against it, use their various marketing techniques and financial inducements to get doctors to prescribe the drug to larger and larger populations of patients.

Many of these powerful marketing techniques have been described by me in a series of previous posts (the last one being my post of August 7, 2012). The profits to be gained by so-called off-label marketing are enormous, and completely dwarf even the billion dollar plus fines levied by the U.S. Department of Justice. The fines are considered to be just a cost of doing business by Big Pharma.

This situation has also led to an explosion of disease mongering, in which the definitions of disorders like bipolar disorder for which certain drugs are FDA-approved are expanded beyond all reason (see my posts of 10/20/12 and 8/13/11).

The damage to patients, especially in the field of psychiatry, has been particularly horrendous. People with family and behavioral problems who are in desperate need of psychotherapy are instead given only drugs, many with potentially toxic side effects.  Patients unfortunately are all to eager to buy in to the proposition that their emotional problems or those of their children are merely the result of some brain dysfunction rather than their own behavioral difficulties.

(Disclaimer for the anti-medication lot: of course some psychiatric conditions do indeed result from brain dysfunction, and for those medication is the primary and most effective treatment, and psychotherapy is next to worthless. Which ones are those?  Read this blog! Also, medications can control anxiety and emotional reactivity so that psychotherapy becomes even more effective).

Just as an aside, readers may wonder if I think it should be illegal for doctors to prescribe medications for non-FDA approved indications. This is a complicated question, because of the crazy way the FDA in the U.S. works. For example, we know that if one SSRI antidepressant (Prozac, Paxil, Zoloft, Lexapro, Luvox, Viibrid) works for, say obsessive compulsive disorder, then they all do.

However, once one drug company does the studies that result in their getting an approval from the FDA for their product for this indication, the other drug companies have no financial incentives for doing studies with their own product. Doing the studies is expensive, and they know doctors know about the if one-then all idea, so they will use the other me-too drugs off label. I don't see anything wrong with doctors doing so in properly diagnosed patients (which, BTW, is unfortunately a big "if" nowadays).

Also, sometimes there is widespread clinical experience that shows that a given drug is effective for a certain indication for which studies have not led to FDA approval for that indication. For instance, many of us have successfully used SSRI antidepressants in patients with borderline personality disorder to decrease their emotional reactivity (neuroticism). The drugs do not stop the hyper-responsiveness that these patients show to problematic interactions, but they do raise the bar. It takes a higher level of stress to get them into a state of dysregulation than it would in an unmedicated state.  Hardly a cure, but still very useful.

There have been many studies to show that SSRI's do this, some performed by Emil Cocarro, a highly respected researcher. But so far, no drug company has, for a variety of reasons, made a petition to the FDA for this indication.

Dr. Emil F. Cocarro

I would be very much opposed to any action that would limit my ability to help my patients in this way. Unfortunately, many of my colleagues listen to drug company propaganda and use drugs in ways that are very inappropriate. I'm not sure what the solution to this quandary is, but of one thing I am certain: allowing Big Pharma to market drugs for unapproved indications ain't it.

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