Physicians should not be used for FDA ad enforcement

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 circumstances 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, demonstrating 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.

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 Pharma 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, Kellogg, 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.

Michael Kirsch is a gastroenterologist who blogs at MD Whistleblower.

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