Power, Knowledge, and Big Pharma: Preliminary Reflections on the Sorrell Vacuum
posted by Frank Pasquale
I have previously commented on Sorrell v. IMS Health, as a co-author of an amicus brief, a Pharma FaceOff panelist, and a blogger. I’m disappointed by today’s ruling, for reasons largely elaborated in Justice Breyer’s dissent. As he observes, the majority opinion “reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decision-making where ordinary economic regulation is at issue.” But I’m not surprised at the Lochner revival, given the First Amendment maximalism of the Citizens United Court. For this Court, “free expression” will have to do in the information age what “freedom of contract” did for the early decades of the 20th century: erase even small and incremental steps toward a fairer social order.
Bill McGeveran has characterized Kennedy’s majority opinion in the case as relatively limited, a surgical strike against an overreaching and incompetent state legislature. I want to respond to his interpretation in a future post, after I’ve digested the opinion a bit more. But for now, I’d like to focus a bit of attention on the types of problems Vermont was addressing, to give the case more of a human face. For behind all the familiar Kennedy rhetoric about sacred speech, deeply disturbing industry practices motivated Vermont’s law.
Both PhRMA and IMS Health want us to believe that the case is about the life-saving power of a marketer to recommend drugs to oblivious doctors once it has access to their prescribing records. Never mind that, as Dr. David Orentlicher notes, “For $98 a year . . . physicians can subscribe to The Medical Letter on Drugs and Therapeutics, a respected and independent, biweekly newsletter that provides evaluations of prescription (and over-the-counter) drugs.” Maybe detailing, on occasion, saves lives. But, as the dissent observes, Vermont’s law allowed doctors to permit distribution of their prescribing records in order to receive personalized solicitations. They only needed to opt in.
Now why did Vermont doctors petition the state to limit access to prescriber records? And why might a rational physician choose not to opt in? Hundreds of pages of empirical studies show the problems caused by detailing; many are cited in Breyer’s dissent. But to make the situation a little more concrete, consider some of the literature a physician who rarely prescribes, say, pscyhotropic drugs, may now be reading. These examples are all drawn from two recent pieces by Marcia Angell in the NYRB:
A large survey of randomly selected adults, sponsored by the National Institute of Mental Health (NIMH) and conducted between 2001 and 2003, found that an astonishing 46 percent met criteria established by the American Psychiatric Association (APA) for having had at least one mental illness within four broad categories at some time in their lives. . . . The new generation of antipsychotics, such as Risperdal, Zyprexa, and Seroquel, has replaced cholesterol-lowering agents as the top-selling class of drugs in the US. . . . [Author Robert Whitaker] is outraged by what he sees as an iatrogenic (i.e., inadvertent and medically introduced) epidemic of brain dysfunction, particularly that caused by the widespread use of the newer (“atypical”) antipsychotics.
***
The pharmaceutical industry influences psychiatrists to prescribe psychoactive drugs even for categories of patients in whom the drugs have not been found safe and effective. [There has been an] astonishing rise in the diagnosis and treatment of mental illness in children, sometimes as young as two years old.
The FDA approves drugs only for specified uses, and it is illegal for companies to market them for any other purpose—that is, “off-label.” Nevertheless, physicians are permitted to prescribe drugs for any reason they choose, and one of the most lucrative things drug companies can do is persuade physicians to prescribe drugs off-label, despite the law against it. In just the past four years, five firms have admitted to federal charges of illegally marketing psychoactive drugs. AstraZeneca marketed Seroquel off-label for children and the elderly (another vulnerable population, often administered antipsychotics in nursing homes); Pfizer faced similar charges for Geodon (an antipsychotic); Eli Lilly for Zyprexa (an antipsychotic); Bristol-Myers Squibb for Abilify (another antipsychotic); and Forest Labs for Celexa (an antidepressant).
Despite having to pay hundreds of millions of dollars to settle the charges, the companies have probably come out well ahead.
Whereas IMS Health’s counsel described detailing in oral arguments as “information about lifesaving medications where the detailer goes in and talks about double blind scientific studies that are responsible for the development of drugs that have caused 40 percent of the increase in the lifespan of the American public,” Angell marshals an impressive array of evidence on the unreliability of pharma marketing, and even the underlying studies some of it is based on. Angell also compiles surprising details about the pervasive role of pharmaceutical firm influence over the social construction of mental illness. When you consider the industry’s targeting of “key opinion leaders” (professors and practitioners at elite medical centers), civil society groups, and the DSM, Vermont’s law seems an almost trivial response to a juggernaut of profit-driven promotions for mind cures. And yet even that small step (toward allowing physicians more control over how they are approached by detailers) offended the delicate sensibilities of the majority.
The Breyer dissent’s litany of regulated industry information practices should have dampened Kennedy’s abstracted enthusiasm for a “commercial marketplace” that “provides a forum where ideas and information flourish.” But in the vacuum of First Amendment fundamentalist thought, the complex ecology of fair information practices and calibrated disclosure cannot survive. It’s all-or-nothing: as soon as some parties gain access to prescriber data, everybody has to have it. Doctors can’t choose to structure their interactions with detailers based on profiling of their practices; rather, they face the stark choice of letting in marketers with access to all the prescribing practice data the state requires pharmacies to maintain, or not to talk to them at all.
In Sorrell, privacy and free expression become clashing rights, rather than social values that have long been reconciled (and occasionally reinforced one another) in complex regulatory schemes. We need to maintain that tradition of nuance in information law. Sadly, Sorrell turns its back on it.
June 23, 2011 at 9:33 pm
Posted in: First Amendment, Health Law
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Responses (4)
Brett Bellmore - June 24, 2011 at 6:41 am
“As he observes, the majority opinion “reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decision-making where ordinary economic regulation is at issue.””
And, as Justice Kennedy observed, “The Constitution “does not enact Mr. Herbert Spencer’s Social Statics.” Lochner v. New York. (Holmes, J., dissenting). It does enact the First Amendment. …”
Yes, the vacuum of rule of law thought, where once an amendment is ratified, it has to be enforced, even if you have excuses as to why it would be better violated. Privacy and free expression ARE conflicting rights, “Two can keep a secret if one is dead.”. If you want something private you don’t tell other people. And I know which one is to be found in the Constitution.
But the situation is not as dire as you make it out to be. While the legislature can not silence those who learn something from repeating it, those who tell you something can contractually bind you to not reveal it. Neither Social Statistics NOR the First Amendment prohibit that approach to nuanced privacy. The latter simply dictates that it’s the actual participants in the conversation which must adopt it, not some third party.
Joe - June 24, 2011 at 7:49 am
“If you want something private you don’t tell other people.”
So, in this case, if you are sick, don’t go to the doctor and/or get medicine necessary for your health. It’s pretty simple really. You might die, but you might do so privately.
OTOH, we can set up by contract or law certain associations where what you say does remain private, except with the specific person you are talking to. Priests, lawyers, doctors and so forth. The issue here was the rule set forth here was badly drawn. A better law might have past muster.
See, e.g., the discussion at Scotusblog.
Elaine - June 24, 2011 at 2:24 pm
I agree with the general sentiment of this post, but can’t help thinking that the buck stops with the physicians. If a doctor is not familiar with or comfortable about prescribing off-label, he/she should either refrain from doing so or do more independent research. The argument that “the pharmaceutical detailer convinced me to do it” seems rather weak, particularly since physicians cling dearly to the concept of professional autonomy in other contexts (e.g., resistance to evidence-based medicine).
JohnLopresti - June 24, 2011 at 5:15 pm
At first glance, I think the state built an imperfect preserve of privacy for doctors, and that congress is too much at the mercy of the chemical industry and data filtering companies to improve upon the protections Vermont was trying to impart to physicians seeking privacy in prescribing.
The raw invasiveness of the resultant ruling in the Sorrell case, 10–779, does little to supply a judicial remedy to the problems datamining create for prescribing doctors.
The net outcome reminds me of the days of the dawn of the internet, when website owners grasped at then-new technologies to market products and services to site visitors, and the government thought economic motivations counseled it stay on the sidelines rather than interfere with the creation of the new technology called “cookies” as a way to follow surfing and refine advertising effectiveness. The monetary side of building the internet was too important a phase to risk over-suppressing the genesis of a milieu many people individually, and in various aggregations, desired: the internet’s creation was that important, especially early in its life, and even to then-existing regulators.
I am not sure I have a better answer, for doctors, than the seemingly profligate one Scotus offers in the Sorrell opinion; yet, like the allure of early internet’s advent, there is something substantial apparently about to be lost as datamining peers behind physicians’ confidential data firewalls.
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