Wednesday, July 15, 2009

Will Pharma's (Tax) Free Speech Be Limited?

Dan Neil has an absolutely marvelous column in the LA Times about pharma's bitching/moaning regarding increased regulation of its advertising and its potential loss of tax writeoffs associated with drug ads. It's nice to know that when I'm watching a misleading advertisement for, say, Cymbalta or Abilify, pharma is writing off the advertising cost on its tax bill. Big Pharma's legal consultants have weighed in for years on this topic, using such terms as "starkly unconstitutional," "censorship," "plainly violates the First Amendment", and adding that taking away the tax deduction is "Draconian punishment" - see this document from the pharma-friendly Washington Legal Foundation and just try to keep a straight face.

Neil writes that:
Currently in draft form, these [FDA] rules would dramatically raise the legal bar for risk disclosure. Not only would advertisements have to fully explicate serious side effects, the nature of adverse reactions, the risk of dependence, dangerous drug interactions and so on, but all of that would also have to be communicated in the most direct, unambiguous and, if you will, artless form possible.
And, picking some of the low-hanging fruit, Neil goes on to describe two of my most hated ads:
Consider, the current 75-second spot for Abilify, a powerful antipsychotic drug marketed as a potential add-on to antidepressants. At the 33-second mark, the warnings start: "thoughts of suicide," "elderly dementia patients . . . have an increased risk of death or stroke," "uncontrollable muscle movements [that] may become permanent" and so on. The astonishing thing is that Bristol-Myers Squibb spent more than $35 million in the first quarter alone to market this witch's brew.

Seizures, death, trouble swallowing. Jeez, I get depressed just watching the ad. Maybe that's the idea.

Another wonder drug -- as in, I wonder if this will kill me? -- is Wyeth's Pristiq. Again, the potential adverse reactions are alarming: "Antidepressants can increase suicidal thoughts and behaviors in children, teens and young adults," the ad says. "May cause or worsen high blood pressure, high cholesterol and glaucoma."

Scary stuff. And yet, the FDA might say, not scary enough. Because the voice-over rambles on with a litany of potential side effects, some of which is quite hard to follow, the commercial seems to violate the FDA's constraint that advertisements not overwhelm viewers' "cognitive load." On a more prosaic level, the imagery of this suffering woman suddenly redeemed by this medication, so that now she's playing with her family at the park, seems to vastly over-promise relief.
Vastly over-promising relief, indeed. Watching Congress, the FDA, the pharma-funded academic hired guns, and lawyers on these issues will make for an entertaining spectator sport. Not nearly as engrossing as watching the DSM-V drama unfold (1, 2, 3), but still a lot cheaper than going to a Yankees game.

1 comment:

Anonymous said...

The pharmaceutical industry only believes in freedom of speech when it's in their own interests.

For example FDA employees can be fired for saying anything publicly that would would suggest any inappropriate activities between the FDA and the pharmaceutical industy.

This is reflected in the following policy and procedures of the FDA Center for Drugs:

4641.3R Outside Activities (Revised 7/1/2008; Posted 8/8/2008

Which indicates that outside activities including "speaking, writing, or teaching" 'are prohibited when they' "create an adverse effect on the image of FDA."

This MaPP can be found at the following site: