June 24, 2011
Worth Reading This Week
Frank McClellan, Health Disparities, Health Care Reform, Morality, and the Law: 'Keep Your Government Hands Off My Medicare', SSRN/Temple Law Review
Lance Gable, Reproductive Health as a Human Right, SSRN
David Hyman, Convicts and Convictions: Some Lessons from Transportation for Health Reform, SSRN/U. Pa. Law Review
Barry Furrow, Regulating Patient Safety: The Patient Protection and Affordable Care Act, SSRN/U. Pa. Law Review
Henry Aaron, The Independent Payment Advisory Board — Congress’s “Good Deed”, NEJM
June 23, 2011
Turning a Shield into a Sword
Thirty-five years ago, in Virginia State Board of Pharmacy, the Supreme Court recognized its "commercial speech" doctrine so it could protect the interests of consumers in paying lower prices for their prescription drugs. Yesterday, in Sorrell v. IMS Health, the Court invoked the commercial speech doctrine on behalf of pharmaceutical company marketing strategies that drive up the cost of prescription drugs.
The decision is troubling for a number of reasons. First, it allows pharmacies to sell information from patients' prescriptions so drug companies can use that information in ways that are harmful to patient interests. But any information gleaned from patients by health care providers should be used only for the good of the patients. Second, the Court sacrificed patient interests in favor of corporate speech interests even though there were absolutely no restrictions on what drug companies can say to physicians when marketing their drugs. Third, the Court raised its level of review for commercial speech from "intermediate scrutiny" to the more rigorous level of scrutiny it employs for non-commercial speech.
While in some sections, the Court wrote an opinion that could have broad implications for regulations of other corporate speech, there also were parts that suggested a narrower reading. For example, the Court viewed the Vermont statute as targeting the use of prescription data by drug company marketers while letting just about anyone else use the same data. The Court suggested that a statute would past muster if it broadly protected prescription information with narrow exceptions for use (e.g., a statute more like HIPAA). Still, it's difficult to see how the FDA's ban on off-label promotion of drugs by pharmaceutical companies can survive judicial scrutiny after this decision.
Power, Knowledge, and Big Pharma: Preliminary Reflections on the Sorrell Vacuum
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 theLochner 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 co-blogger (and doctor) David Orentlicher notes, “For $98 a year . . . physicians can subscribe toThe 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.
X-Posted: Concurring Opinions.
Pharmaceutical Companies Win, Patients Lose
In a 6-3 decision, the Supreme Court struck down Vermont's effort to protect patient prescription information from use by pharmaceutical companies for marketing purposes. I'll have more to say later, but the Court was concerned much more about the first amendment interests than the patient protection interests.
June 22, 2011
New Graphic Cigarette Warnings
The FDA unveiled its new warnings for cigarette packaging and advertising, the first change in warnings in more than 25 years. You can see the new graphics and find out other information at the FDA's website. One warning depicts a man smoking through a tracheostomy with the caption that cigarettes are addictive.
June 21, 2011
Supreme Court Avoids a Greenhouse Gas Showdown – For Now
The big news in environmental health today is yesterday’s ruling by the Supreme Court that the lawsuit brought by several U.S. states claiming that Greenhouse gases emitted by five power companies was a nuisance could not go forward. In American Electric Power v. Connecticut, the Judges ruled in an 8-0 decision that the Clean Air Act pre-empted any federal common law nuisance claim, and the Environmental Protection Agency, not the Court, would determine how to address any dangers to the public. The decision was widely reported included good summaries in the LA Times, NY Times, and the Washington Post.
The draft rules are due out shortly, but it is likely they will be severely weakened or delayed by legislation or other pressure from Congress. House Republicans made this clear in last week’s Energy and Commerce subcommittee hearings, as reported here. To this writer, the opinion was expected, and is good law, since the EPA is about to release its greenhouse gas rule, has the scientific expertise to evaluate the health risks, and is charged with implementing the Clean Air Act. But the courts will inevitably end up deciding whether the rule is adequate, and if it is found lacking, the states may still be able to attempt to recover for the harm caused by the gases. A key part of the opinion, delivered by Justice Ginsberg, was a reminder that plaintiffs have a remedy in the federal courts in the event that the EPA fails to act or fails to issue reasonable regulations. The Republicans need to be read this warning carefully. If Congressional opponents end up pressuring EPA too much and sidetracking the rule, as threatened, a federal tort claim can be refiled, and this time it could be successful.
Wrong Site Surgery and Rocket Science
We have long believed that the eradication of wrong site and wrong patient surgery ranks amongst the lowest hanging adverse event fruit. Since the Joint Commission introduced its "timeout" and other procedures, available here, surely the problem is in decline. According to a perceptive Washington Post/KHN piece by Sandra Boodman, available here, that doesn't seem to be the case. The following extract quoting the Joint Commission president is illustrative:
“I’d argue that this really is rocket science,” said Mark Chassin... he thinks such errors are growing in part because of increased time pressures. Preventing wrong-site surgery also “turns out to be more complicated to eradicate than anybody thought,” he said, because it involves changing the culture of hospitals and getting doctors — who typically prize their autonomy, resist checklists and underestimate their propensity for error — to follow standardized procedures and work in teams.
June 19, 2011
Guest Blogger Lindsay F. Wiley: The Joint Action and Learning Initiative for a New Global Health Agreement
My last global health law post, on WHO’s new PIP Framework for influenza pandemic preparedness, ended on a rather depressing note about the low likelihood of a strengthened commitment to global health equity at a time when money is tight. I’m going to attempt a rebound today with a post on an ongoing effort to promote a new international agreement on global health.
Larry Gostin and several international colleagues recently published an article on PLoS Medicine heralding their establishment of a new Joint Action and Learning Initiative to promote a new international agreement on national and global responsibilities for health. The article describes the formation of a coalition of civil society organizations and academics from the U.S., the U.K., Germany, Belgium, Norway, India, China, and South Africa to research “key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement and supporting civil society mobilization around the human right to health.” The authors propose that a new agreement is needed to inform global health commitments as the Millennium Development Goals’ time-frame draws to a close. The Joint Action and Learning Initiative (JALI) aims to “clarify the health services to which everyone is entitled under the right to health, the national and global responsibilities for securing this right, and global governance structures that can realize these responsibilities and close major health equities.” In coming months, the JALI will undertake efforts to create the political space required for negotiation of a new agreement addressing these issues.
The agreement was initially proposed by Gostin as a possible Framework Convention (on the model of something like the U.N. Framework Convention on Tobacco Control or the U.N. Framework Convention on Climate Change). Elsewhere, I’ve argued that a Framework Convention on Global Health could make a major contribution to global efforts to adapt to the anticipated health impacts of climate change. Environmental degradation, which is being exacerbated by climate change, is already responsible for a significant portion of global disease burden – especially through its contribution to malaria and diarrheal illness. These problems have tended to be neglected by current law and policy structures. Public health specialists have a a fairly well-developed body of interventions for promoting better health through interventions like drinking water and sanitation improvements and vector control. What has been sorely lacking is the political will to commit sufficient resources to supporting these efforts in the communities where they are most needed. It’s a governance failure that Gostin’s proposed agreement might effectively address.
Recently, as I’ve been working on a project at the intersection of international disaster law and international health law, I’ve begun to think that the Framework Convention model is perhaps not ideally suited to the focus of the JALI’s proposed global health agreement. A different model, the Framework Agreement, might be a better fit. Framework Conventions are international instruments designed to set forth overarching commitments that will be fleshed out later in the form of protocols. For example, the Kyoto Protocol provided the emissions reduction targets that gave content to the broad commitments outlined in the Framework Convention on Climate Change. Such a model works well to structure continuing negotiation of concrete, binding obligations. But the subject of the proposed global health agreement – which would aim to meet “the basic survival needs of the world’s least healthy people” – might lend itself to a more flexible soft law mechanism. Framework Agreements – such as the highly successful Hyogo Framework for Action on Building the Resilience of Nations and Communities to Disasters – work well as a platform for promoting and supporting Member States’ domestic efforts to reach internationally agreed-upon goals and commitments to assistance.
Whatever form it takes, a new international agreement on global health could go a long way toward correcting what I perceive as an imbalance in international health law between the real health policy priorities of poor countries and the legal obligations imposed on them (primarily through the recently revised International Health Regulations, which include significant obligations to build rapid disease surveillance and response capacity to address disease outbreaks with potential for cross-border spread) to ensure “global health security” in the face of mutual interdependence.