October 5, 2012

The Fraud Behind the Fraud of Off-Label Drug Marketing

By Gordon Schnell

It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label marketing practice is illegal.  But that has not stopped virtually every major pharmaceutical company from engaging in it to boost sales.  See What Is Going On With Big Pharma?

Just look at the litany of recent nine and ten-figure Big Pharma settlements for engaging in this off-label mischief — Glaxo (Paxil and Wellbutrin); Abott Labs (Depakote); Johnson & Johnson (Risperdal); Pfizer (Bextra); Eli Lilly (Zyprexa); AstraZeneca (Seroquel); Bristol Myers Squibb (Plavix and Pravachol).  The list goes on and on.  The practice generally has involved coaxing, even paying, doctors to prescribe the drugs for non-FDA approved uses even when doing so may pose health and safety risks.  With its best-selling antidepressant Paxil, for example, Glaxo was paying the medical community to prescribe the drug to children even though the FDA had only sanctioned it for adults and even though the drug had been linked to increased suicide in children. 

Afterall, doctors are not bound by any off-label restrictions.  They are permitted to prescribe drugs as they deem fit regardless of the specific uses or groups for which the FDA has approved them.  And they are certainly capable of making their own decisions about what is best for their patients.  So, why not nudge them along a path that maximizes the scope and breadth of pharmaceutical sales.  That seems to be the thinking of the big drug companies.  As long as the doctors willingly sign on, who is to complain that the drug makers have done anything truly against the patients’ best interest.

The obvious flaw in this thinking is that it ignores the invaluable role that the FDA is supposed to play in overseeing our medicines and ensuring they are safe and effective.  And it ignores the financial incentives that drive some of the more impressionable (or less scrupulous) healthcare providers to foster these off-label uses.  Unfortunately, lavish trips to exotic locations, expensive meals at swanky restaurants, and other pecuniary enticements and gifts can go a long way in steering certain healthcare professionals towards choosing one product over another.

But there is an even more insidious problem lurking about.  It involves what appears to be a widespread effort to dupe even the most well intentioned of the medical community into endorsing these off-label uses.  One way is through the practice of ghostwriting.  This is when a drug company writes an article for a medical journal and then pays a well respected doctor, typically associated with a prestigious university, to sign on as the author.  This was one of the tactics that Glaxo employed, and was heavily fined for, in pushing Paxil on kids.  In a 2010 paper he prepared on the subject, Senator Chuck Grassley (R-Iowa) reported on how pervasive this practice has been and the undue influence it can have on physician prescribing practices. 

There is also the equally troubling practice of doctors writing journal pieces promoting off-label uses without disclosing that they are being paid by the drug maker to promote the very off-label uses they are endorsing.  A recently released report in PLoS Medicine found that this behavior may be more widespread than anyone realized.  It found that of the more than 400 articles it reviewed that were written by doctors on a drug company’s payroll, only 15 percent of them disclosed the conflict of interest. 

It would thus appear that not much comfort can be taken in the notion that doctors, most of whom heavily depend on these medical journals for guidance and direction, are acting with full information in their off-label prescribing decisions.  

Luckily, help is on the way with the Physician Payments Sunshine Act (part of the Patient Protection and Affordable Care Act).  When fully implemented sometime next year, it will require drug makers to fully disclose all payments or gifts over $10 in value to any healthcare providers.  This should serve as some discouragement to the types of illicit payments that are at the center of Big Pharma’s off-label campaign.  But to really get rid of the problem, the entire medical community — the doctors, the universities, the journals — will need to stand up against these off-label shenanigans.  No ghostwriting.  No money to push a particular med.  And no concealing obvious conflicts of interest.  Only then can we really be sure that the drugs we are taking are as safe and effective as they are supposed to be.

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