Bearing witness to the commercial maneuvers of the Pharma Industry has never been a task suitable for anyone prone to queasiness. The latest reminder of the moral banana peel upon which Big Pharma slips and slides is GSK‘s $3 billion fine, imposed due to an overreporting of off-label prescribing opportunities (primarily for Wellbutrin) and an underreporting of safety concerns (for Avandia). It’s the most recent in a long roster of hefty corporate penalties that has included Pfizer ($2.3 billion), Merck ($1.6 billion), and even the late Cephalon ($425 million). Perhaps it has become a pharma rite-of-passage: Just as one might be expected to carjack a BMW in order to belong to a street gang, a pharma company just isn’t going to be taken seriously in the machismo department if it hasn’t experienced a stern fiscal dressing-down by the Department of Justice.
Speaking of which, Judith Warner wrote a piece on “fraud” in the pharmaceutical industry (http://ideas.time.com/2012/07/06/glaxo-fine-what-will-stop-big-pharma-fraud/?iid=op-main-lede) that was published today in Time. She cited GSK’s $3 billion fine as another ineffective penalty that is simply folded into the corporate cost-of-doing-business, far exceeded by the proceeds accrued via the misconduct. While the latter is true, the assumption that the penalties for what was done a decade ago has no effect on current marketing practice strikes NIR as questionable: $3 billion is enough to catch the attention of the industry going forward, even if unable to erase the errors of the past.
Even more specious is Warner’s assumption that this kind of behavior springs from an “imbalance of power between the industry and our government that is seriously askew”, referring specifically to the reliance of the FDA upon industry-paid ‘User Fees.’ The premise is that, since the Pharma industry largely provides the funds with which the Agency operates, that this gives the Industry untoward power over the FDA’s regulatory behavior. The problem with the premise is that it infers that Pharma could use this as a threat, to withdraw that funding, to go elsewhere, thereby jeopardizing the existence of a regulatory body that is dependent upon Pharma. But this is an illusion: the FDA is the sole gatekeeper for the most lucrative pharmaceutical market in the world, and Pharma does not have the option of saying–‘play ball with us or we’ll take our business elsewhere.’ In dealing with a monopoly, particularly one in the public sphere, ‘client’ leverage is minimal. By Warner’s premise, citizens waiting impatiently in line at the DMV to obtain a driver’s license might consider yelling; “My taxes pay your salaries: If you people don’t start cutting corners and speed this up, I will leave without getting my driver’s license!” Try it some time, let us know how it works out.
The User Fee structure reflects a peculiarly American ambivalence around funding government activities, but it is a red herring when it comes to corporate misconduct. It does not imbue the pharma industry with a sense of power over the FDA and its regulatory machinations: Indeed, now, as always, if the FDA does not feel like doing something, they don’t. Their only concern is with Congress, which does control the budgetary purse strings by which the FDA’s funding, whatever its source, is doled out, and has the power to skewer and cook bureaucrats under the public broiler of a Congressional hearing.
But this brings us to someone previously beyond even our capacity for cynicism, Dr. Drew Pinsky. This one cuts a little deeper. Without Dr. Drew, the United States would know even less than it does about human sexuality, though we would probably still be overly knowledgeable about Celebrity Rehabs. But even wearing his multiple media hats, Dr. Drew has consistently conveyed a demeanor of empathic and ethical reasonableness. Now, it turns out he is at best, two out of three. If the DOJ is correct, Drew Pinsky was paid $275,000 by Glaxo for assisting their Wellbutrin marketing efforts, by discussing the pro-libidinal effects of that antidepressant on his radio show, Loveline. Pinsky has since stated that the payment was an ‘educational grant’ from Glaxo, one that paid for a number of his endeavors in the realm of exploring ‘intimacy and depression.’ Whatever. Our faith in the fundamental underpinnings of contemporary society continues to erode. It is a bitter, off-label pill to swallow.