Sunday, June 13, 2010

FDA ‘Bad Ad’ Program Recruits Physicians. Pharma Beware!

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One of the advantages of marrying an immigrant is having intense exposure to another culture. My wife’s Russian heritage, and her family, have enriched my own life immeasurably. The trip that I took with her and my brother to Russia in 1990, where she served as our personal translator, was unforgettable.

During the early years of our relationship, I heard stories about her family that seemed incredible to an American like myself who was raised in ordinary cirumstances in suburbia.

In Russia, her father, uncle and close relatives were arrested and imprisoned on absurd charges. Her family, like so many others, was subjected to persecution and anti-Semitism. One would imagine that her family would celebrate when Stalin died in 1953. Instead, I am told that my mother-in-law, whose family had suffered under his brutal fist, was in tears, demonsrating the deep reach that this tyrannical leader had on the populace. He had a cult of personality, an intoxicant that numbed the senses of even his victims. To this day, I am sure there are still pockets within the former Soviet Union that celebrate him.

One of Stalin’s most feared institutions was his security apparatus. In addition to conventional law enforcement and intelligence apparatus, there was a nebulous web of informers across the country, ordinary citizens who were recruited to spy on their neighbors. Imagine this scenario. Your coworker confides to you that he thinks that their Communist boss is inept. However, this is not innocent factory floor banter. The coworker is an informer and was coerced under threat to approach you by the KGB, or some similar agency. You are subsequently arrested for failure to report him to the authorities.

Here in America, we don’t spy on each other, although the Bush folks fumbled when they tried to recruit Moslems to be vigilant and squeal on other Moslems.

Our own government, albeit on a much smaller scale, is currently recruiting physicians to serve as government informers. As an ardent James Bondophile, I have always fantasized about life as a spy using secret cameras, recording devices and driving the famed Aston Martin. Any male who denies having a similar fantasy couldn’t pass a lie detector test.

The Food and Drug Administration (FDA) wants physicians to turn in Big Pharma marketing and promotional materials that are misleading, that are poisoning us with information that reaches beyond FDA’s approved indications and regulations. This new government initiative is called the ‘Bad Ad’ program, a name so absurd, that it must have taken months of committee meetings to create. Physicians who encounter a rogue drug rep, or promotional materials that promise more than the FDA permits, can anonymously report the offender via an email address and phone number, which I will not provide here.

There is a Stalinesque aura to all of this. If I ask a drug rep about off label use of a drug, am I doing so to acquire medical information for a patient, or am I serving as a government agent, a G-Man, who is setting a trap?

Is this a good idea? Will this foster collaboration and trust between the medical profession and the pharmaceutical industry? Is it physicians’ role to serve as an enforcement arm of the government?

Personally, I believe that the FDA regulations on marketing to physicians is overly restrictive. For example, every physicians prescribes off label medicines, but we can’t discuss these uses with pharm reps who are often excellent resources on unapproved medication uses. These sales folks may call on leaders in the field and may be able to relate to us nuances and new uses of medicines that can benefit our patients.

I know that these guys and gals are not physicians, but are trying to sell products, like everyone else in the marketplace. Sometimes, marketers go over the line. For example, Kelloggs, the cereal company, had to take back two health claims:

• Frosted Mini-Wheats can improve kids’ attention spans.
• Rice Krispies can enhance kids’ immunity.

In these cases, the Federal Trade Commission was right to intervene. Drug promotion can also go over the line and need to be reined in and sanctioned. I am not sure, however, that the line is in the right place presently. What is your view?

I don’t like the ‘bad ad’ program, and I don’t intend to have the FDA on my speed dial. I don’t like the precedent of folks being encouraged to turn in colleagues. Imagine where this idea could take us.

This post has riled me up and I need to calm down. I need an 'off label' anxiolytic.  It’s time for a Vodka Martini, shaken not stirred.

5 comments:

LeisureGuy said...

You're over-reacting, I think. I don't see that the government has asked for entrapment, which is your interpretation. They are simply asking that, should you get information or marketing materials that are clearly misleading, to let them know. What's wrong with that? Indeed, I would hope that any physician, seeing an ad or getting marketing material that is obviously wrong or seems to merit investigation would complain to the FDA, just as I routinely complain about business practices or transactions that strike me as unethical or illegal.

Your idea---that physicians should silently abet medical marketing that they know is wrong---is quite repulsive me, and makes the physician an uncompensated member of the pharma company team---which, come to think of it, pharma companies constantly try to do with free gifts, honoraria for trivial exercises, contributions to conferences, and so on.

I understand the conservative impulse to go along with Big Business, but sometimes it's ridiculous. You really think our government is equivalent to Stalin's Soviet Russia?

secondbasedispatch.com said...

Let me see if I've got this straight. In addition to having to defend yourselves against potential lawsuits, and argue with insurance companies and possibly soon government regulators why your best professional judgment for patients should honored, you're now also supposed to be ad watchdogs? When are any of you supposed to find time to actually practice medicine?

Wouldn't it be better to just ditch all those annoying drug ads on TV? They all sound like creepy legal briefs anyway.

Michael Kirsch, M.D. said...

@LG, I don't think it should be the role of physicians to serve as a stealth enforcement informer with folks that we collaborate with. This would disrupt the relationship. Obviously, a physician - or anyone - should do the right thing when they discover serious misconduct by anyone. But, there needs to be common sense. If a colleague wants to ask me informally about a patient, do I cover my ears because it might violate HIPPA? If I ask a drug rep a question about a product that he knows intimately, I want him to answer freely, without fear that I am wired. If he gives me the silent treatment instead, then who benefits from this censorship?

LeisureGuy said...

Clearly you can remain silent when you see medical marketing materials that are wrong or misleading. Indeed, most physicians will. I just don't see anything particularly wrong with reporting such things. Indeed, most physicians remain silent even when they observe a colleague doing malpractice, so far as I can tell from news reports and court cases.

Michael Kirsch, M.D. said...

For the reasons stated in the post, most physicians wouldn't regard a discussion of off label use of a drug with a drug rep as a transgression, even though it may be technically improper. I regard this as information gathering for the benefit of my patients. Should a rat on these guys?

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