January 1, 1970 (Vol. , No. )

Taralyn Tan Ph.D. Curriculum Fellow Harvard Medical

Here’s a scenario that most people can relate to from their childhoods: You ask your mother if you can go over to your friend’s house. Mom says yes – she knows where you’ll be and when you’ll be home. Then (here comes the twist!) your friend suggests that you both, oh, I don’t know…sneak into a movie or go play near the river or something…something that your mother has explicitly forbidden. So what do you do? Go behind your mother’s back??? Well, your answer may vary depending on how rebellious you were as a child, but let me give you the correct answer: No, you don’t. And why don’t you? Because you have integrity. Do you remember what that word means? Because it sure seems like many people and corporations these days don’t. For those of you dusting off the cobwebs in your head, it means the adherence to moral and ethical principles. It means honesty.

So flash forward beyond the dilemmas of youth, and here’s another scenario: A pharmaceutical company proposes a specific drug at a specific dosage, to treat a specific ailment. After much evaluation and testing, the FDA approves it. Then the company (even without the coaxing of a friend) decides to market the drug for uses and at dosages that were specifically declined by the FDA for approval. (All due to that pesky ol’ thing called “safety.” The nerve!)

Do you see parallels between these two anecdotes? Need I define “integrity” for a second time in three paragraphs? Though the “right thing to do” in this second scenario seems obvious, this is a serious matter in the pharmaceutical industry today. There are many instances of so-called “off-label” marketing – the marketing of FDA-approved drugs for non-FDA-approved purposes. This greed-driven practice is deceitful, malicious, and just plain wrong. Pfizer learned this the hard way last month when it settled with the US government to pay an unprecedented $2.3 billion fine in connection to various off-label and illegal advertising efforts. They weren’t the first to do it – and they certainly won’t be the last – but good for the United States for sending a crystal-clear signal to other scheming pharmaceutical companies out there. (How sad is it that our morals are inextricably linked to our pocketbooks?)

However, thus far the picture I have painted has included a single villain – the pharmaceutical company. Yet, I don’t entirely place the blame on the company. There is another party who demonstrated an alarming absence of integrity in connection to the Pfizer litigation, namely, the affiliated medical doctors. These doctors accepted all-expense paid vacations to expensive resorts, cash payments, free massages, and other kickbacks from Pfizer in return for prescribing Pfizer’s drugs off-label. Throughout the legal proceedings the finger of justice was pointed at Pfizer. I want to know, where is the corresponding slap on the wrist for the opportunistic physicians? Or, the better question – why do we present doctors with this temptation in the first place? It is illegal to market drugs off-label, but it is not illegal to prescribe drugs off-label. Well, aren’t we just putting a cookie jar in front of physicians, instructing them to “just eat one”? With the moral decadence in our society, one can’t but expect that at least some doctors will cave under the possibility of a free trip to the Bahamas. (Sun, hammocks, drinks with little umbrellas in them – it doesn’t sound like a bad gig.)

We have the FDA for a reason. We entrust its Center for Drug Evaluation and Research with the task of evaluating drugs before allowing them to be sold. So why are we simultaneously usurping this organization by giving individual physicians the opportunity to make their own rules? This seems like a major loophole in the whole “regulation-to-protect-the-public” scheme. So what to do? Let’s attack off-label marketing at its root. If physicians are not allowed to prescribe drugs off-label, then pharmaceutical companies won’t be bribing them to do so. At the same time, there is no use in the companies trying to do the dirty work themselves, either, as what would be the point of advertising a drug for a use for which it cannot be prescribed? With this “two birds, one stone” approach, we can cleave both branches of this bifurcated decaying tree.

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