- Amy Fairchild et al, The Renormalization of Smoking? E-Cigarettes and the Tobacco “Endgame,” N Engl J Med
- Evelyn Tenenbaum, The Union of Contraceptive Services and the Affordable Care Act Gives Birth to First Amendment Concerns, Albany LJ Sci & Tech
- Sharon Long et al, The Health Reform Monitoring Survey: Addressing Data Gaps To Provide Timely Insights Into The Affordable Care Act, Health Affairs
- Kevin Outterson,The Drug Quality and Security Act — Mind the Gaps, N Engl J Med
On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients. Structured around appropriate use criteria developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.
Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria. The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria. In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”
Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.
This is worth a read, and, in my opinion, absolutely right. The discussion is relevant to broader questions of identified v. statistical lives, as well as “choice architecture” questions about how charities ought to seek out donations. Take a look:
Full disclosure: Several years ago my family took advantage of a Make-A-Wish trip resulting from my younger brother’s leukemia. He is now a thriving adult and doing great, and the experience was incredible, especially for those families with children facing terminal diagnoses. But the fact remains that this really has to be seen as a “luxury” charity – and when faced with a stark side-by-side choice of where the dollars could be spent, Peter’s analysis nails it.
Yesterday the CMS issued a document, Options Available for Consumers with Cancelled Policies, that describes four options available to people who received notice that their healthcare plans were cancelled. (I blogged about the cancellations here.)
The first three options aren’t newsworthy: you can buy a new plan from your insurer, buy a plan through the marketplace, or shop outside the marketplace. The fourth option is newsworthy, because the CMS has for the first time announced that people whose plans were cancelled may qualify for a hardship exemption allowing them to enroll in (cheaper) catastrophic coverage.
Not surprisingly the announcement is receiving lots of attention. Seth Chandler has a roundup of some of the early news coverage. Since he posted, Nicholas Bagley blogged here and Jonathan Adler noted the change here.
I am still digesting this interesting news, but have one contribution to the discussion so far. Many people are saying that those in cancelled plans are now “exempt” from the individual mandate, that having a plan cancelled is now itself a “hardship.” That is not quite right in a way that obscures an important aspect of this announcement. The CMS has not exempted anyone with a cancelled plan yet. Continue reading
Art Caplan has weighed in, with a piece for NBC News online, on the debate over the case of a thirteen-year-old California girl whose parents are suing to keep her on life support despite the fact that doctors have pronounced her brain dead. From the piece:
This case is so sad it is almost beyond description. But that fact should not be a reason to take the view that we don’t know what to do when someone is pronounced brain dead.
Brain dead is dead. It is as reliable a way to determine death as declaring that a person’s heart has forever stopped beating. In fact, due to the strict tests and procedures that have to be followed to determine brain death, it is probably even more error-free than pronouncing someone dead due to cardiac failure.
Brain death is not a coma. People wake up from comas—they still have brain activity. Brain death is not a vegetative state. People in a vegetative state still have some, minimal brain activity. Those who are brain dead have lost all brain activity except the random firing of a few cells. They will not come back.
For more, read the full piece.
There’s an interesting post up on the New York Times’ Well Blog about children with three biological parents—in this case, three genetic parents. Here, a mother and a father provided chromosomal DNA (i.e., the standard 23 chromosomes from each leading to the diploid 46 chromosomes), and another woman provided the egg, which included DNA found in the mitochondria (the “powerhouses of the cell” which are found in the cytoplasm of the egg). The idea behind this practice is that women with problems in their mitochondria can still have healthy children with their own genetic material. While it’s not that unusual to talk about children with three biological parents (two genetic and one gestational, as happens frequently with a surrogate mother or egg donor), we don’t often think on examples with three genetic parents (and the potential for a fourth biological (gestational)).
In connection with our work on the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Center, the Petrie-Flom Center seeks to hire a Senior Law and Ethics Associate immediately. This is a full-time position for a doctoral-level hire (J.D., M.D., Ph.D., etc. in law, ethics, public health, social science, or other relevant discipline) with extensive knowledge and understanding of clinical research and its regulation. The Senior Law and Ethics Associate will support a new program aimed at developing creative, practical solutions to reduce seemingly intractable legal and ethical barriers to clinical and translational research.
View the full job description and apply HERE.
Contact Executive Director Holly Fernandez Lynch with questions.
Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria.
As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose of curing disease, but rather for the purpose of speeding growth or increasing feed efficiency. Current estimates are that livestock production consumes 30 million pounds of antibiotics per year, representing 80 percent of the total volume of antibiotics sold in the United States for any purpose. The FDA policy that allows non-therapeutic uses of antibiotics in livestock has in recent years been subject to intense scrutiny by outside advocates, former FDA officials, government investigators, and judges.
The FDA has now taken action to address these concerns by finalizing industry guidelines that it first proposed over a year ago. Under the guidelines, animal pharmaceutical companies would change the labeling of “medically important” antibiotics in two ways. First, the labeling would no longer list production uses (i.e., growth enhancement and feed efficiency) in the approved uses for the drugs. Second, the labeling would require veterinary oversight for therapeutic uses (i.e., the prevention, control, or treatment of a disease), rather than allowing over-the-counter distribution. These changes in labeling would in turn require changes in agricultural use by virtue of other FDA regulations that prohibit off-label use for production purposes.
While the FDA’s action is a step in the right direction toward eliminating non-therapeutic uses of antibiotics in food animals, there are a few features of its strategy that are worth highlighting as they might significantly limit its impact. Continue reading
Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests). For those who have been working long and hard on these issues, they are cause for hope. The needle does move.
First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs. My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money. In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions. (See their newfound commitment to opening up their clinical trial data too.)
The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions. My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies. Yet, something has caused Glaxo to change course.
Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries. The counterfactual is that the NFL could have kept the money, of course. But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf. The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.
This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid. Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies. Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk? If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.
EDIT: Corrected link to NFL story on NYT, and corrected amount from $100M to $30M. Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.
The National Program Office (NPO) for Public Health Law Research (PHLR), a nationally recognized program sponsored by Robert Wood Johnson Foundation for the evaluation of the health impact of laws and legal practices, seeks a postdoctoral fellow who will provide quantitative analytical support to the PHLR team. The successful candidate holds a Ph.D. with significant experience in quantitative methods and law/health policy or a J.D. with strong quantitative and health policy research skills. The individual will produce empirical papers using the quantitative legal data currently on LawAltas.org and provide literature and systematic review support for journal publications, white papers, and grant submissions. This person will become a full member of the NPO for PHLR at the Temple University Beasley School of Law for a period of two years. PHLR staff and affiliated scholars will mentor this person in public health law research methods and provide networking opportunities with leaders in the field of public health law research. The postdoctoral fellow will be required to attend the PHLR Annual Meeting each year.
By Alex Stein
Florida statute, § 766.102(12) (2012), lays down a strict same-specialty requirement for expert witnesses supporting medical malpractice allegations. Specifically, it provides that “If a physician licensed under chapter 458 or chapter 459 or a dentist licensed under chapter 466 is the party against whom, or on whose behalf, expert testimony about the prevailing professional standard of care is offered, the expert witness must be licensed under chapter 458, chapter 459, or chapter 466 or possess a valid expert witness certificate issued under s. 458.3175, s. 459.0066, or s. 466.005.”
The Florida Bar Code and Rules of Evidence Committee recommended the Florida Supreme Court to adopt this statutory provision “as a rule of procedure to the extent that it is procedural.”
The Board of Governors recommended the Court to reject the Committee’s proposal “on the grounds that the provision is unconstitutional, will have a chilling effect on the ability to obtain expert witnesses, and is prejudicial to the administration of justice.”
The Court declined to follow the Committee’s recommendation due to the concerns raised. See here. The Court had another good reason for declining to adopt this recommendation: the provision in question is substantive rather than procedural. See here.
Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.
According to her story:
“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).
While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.
Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”
She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,
“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.
The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.
Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”
While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.
Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.
As the holidays approach, I have a chance to catch up on reading. The Sept-Oct issue of the Hastings Center Report had a paper by Larry Gostin on Michael Bloomberg’s health policy career in New York, and I have seen some of a series of responses by other scholars that will appear in due course. With his usual facility, Gostin recounts the story of Bloomberg’s health department and its innovations in policy – it’s a great piece for a health law class. The piece is also typical Gostin in its framing of the issue of paternalism as a key driver of opposition to many of Bloomberg’s initiatives. And if it is typical Gostin, it is really representative of our field, since Gostin has both drawn on and helped reinforce a widely held belief that the politics of public health are strongly driven by a tension between individual liberty (inscribed legally in civil rights and culturally in individualism and antipaternalism) and public health.
In this framework, paternalism is a premise, not a hypothesis. Gostin writes, “The societal discomfort with Bloomberg’s agenda is grounded, at its core, in distrust of government influence on how autonomous adults conduct their lives.” He describes how health policy-makers are driven to rely on the harm principle to justify policies by “American antipathy toward paternalism.” Yet, and this is also typical of the discourse in our field, he also follows the Sunstein-Thaler line that ultimately denies the empirical assumptions upon which anti-paternalist claims depend: “The public health approach rejects the idea that there is such a thing as unfettered free will, recognizing instead that the built environment, social networks, marketing, and a range of situational cues drive complex behaviors.”
Public health law has been stuck here for a while, accepting that public health policy has and always will be subject to the arbitrary dominion of a mass delusion of autonomy. I think this log-jam is starting to break – and that proponents of effective health laws should be doing all they can to properly discredit and abandon this old trope. A few signs:
So reads the cover of the MIT Technology Review this month. The article is available for free online. The article begins with the story of Kalydeco, which is priced at $294,000 per year.
The company also pledged to provide it free to any patient in the United States who is uninsured or whose insurance won’t cover it. Doctors and patients enthusiastically welcomed the drug because it offers life-saving health benefits and there is no other treatment. Insurers and governments readily paid the cost.
Hold on. If patients can get the medicine for free even when their insurers decline to pay the cost, why would insurers “readily pay the cost?”
- Jonathan Oberlander and Krista Perreira, Implementing Obamacare in a Red State — Dispatch from North Carolina, N Eng J Med
- Sara Rosenbaum, The Enduring Role Of The Emergency Medical Treatment And Active Labor Act, Health Affairs
- Nicole Huberfeld, Dynamic Expansion, SSRN
- Leemore Dafny, Hospital Industry Consolidation — Still More to Come? N Eng J Med
By Chloe Reichel
1) In developing nations, tobacco companies are trying to prevent regulation of their products. They claim that tobacco laws are in violation of trade treaties.
2) In a report released on Thursday, researchers found that gun violence is most effectively addressed as a public health issue. Suggested policies include school programs on conflict resolution and better background checks.
3) In the past year, 36 states have dedicated more funding to mental health issues. While Congress hasn’t passed any legislation on mental health, the Obama administration has published a set of mental health parity rules.
4) Children five and under living in New York City and attending city-licensed preschools and day care centers are required by law to receive a flu vaccination. The Autism Action Network is already planning to sue over this bill.
5) This Wednesday, the FDA approved recommendations that limit the use of specific antibiotics in raising livestock. According to these recommendations, manufacturers of these antibiotics can voluntarily change the uses on the labels of the drugs, so that they cannot be prescribed to speed up animal growth.
6) Testifying in front of Congress, Kathleen Sebelius, Secretary of Health and Human Services, said that an investigation into the failure of Healthcare.gov has been launched. In her testimony, she emphasized that the problems of the website are no longer occurring, and encouraged people to use the site.
Just a quick pointer to an interesting new article out by Kara Loewentheil at Yale, When Free Exercise Is a Burden: Protecting ‘Third Parties’ in Religious Accommodation Law.
Here’s her abstract (posted a few weeks ago before cert was granted):
As of November 2013, over 60 lawsuits have been filed under the First Amendment and the Religious Freedom Restoration Act (“RFRA”), challenging the contraceptive coverage requirement (“CCR”) of The Patient Protection and Affordable Care Act, more than half brought by for-profit employers with religious objections to providing insurance coverage for contraception. The conflict combines questions of the reach of the regulatory state, the nature and purpose of free exercise rights, women’s social and economic equality, and a lightning-rod political debate. No wonder then that these cases have produced a circuit split, and are now primed for a Supreme Court ruling, as two cert petitions in these cases were filed in September 2013. It is no surprise that these cases have produced such divergent results, because the problem lies not with the courts, but with the doctrine, which frames the conflict as being between the State and the religious objector. But as the CCR cases make clear, this relationship is often beside the point entirely. Rather, some religious accommodation cases regulate not only the relationship between the State and the objector, but a variety of conflicts and relationships between the religious objectors and various other rights-holders. The courts and the scholarship have occasionally noticed that such conflicts may exist but have not suggested any systematic way of thinking about or resolving them. To remedy this lacuna, I propose a framework for identifying and analyzing these under-theorized conflicts, elaborating on strands of concern for third parties in the doctrine that have never been fully fleshed out. I argue that once we identify the set of cases in which there are sufficiently weighty third-party interests at stake – whether practical or expressive – to merit deviation from the standard doctrinal framework, the question should be whether the State can provide a solution that respects all the rights in question. If so, it should have an obligation to do so. If not, the group with equality-implicating rights (again, whether practical or expressive) should “win” – with any “tie” going to the third parties, because the purpose of religious accommodation law is to protect the equality of religious objectors, not to privilege religion. The CCR suits present a paradigmatic example in which the State’s most important interest lies in its representation of the rights of third parties, and in which comprehensive solutions respecting all parties’ rights are possible but not doctrinally required, thus providing a clear illustration of why the framework I suggest would be an improvement in religious accommodation law. Nevertheless, there are also ways to better balance the interests involved through use of the existing doctrine, as the last part of this paper demonstrates.
Health insurers are beginning to realize the importance of downstream cost-saving. By paying to keep people healthy now, health insurers avoid major expenditures later when they must cover chronic conditions and hospitalizations. For example, by paying for nutrition counseling and fitness programs for prediabetics, health insurers can reduce the rate of transition to diabetes for their clients, which both saves the insurer thousands of dollars and keeps their clients happier and healthier. This type of innovation is possible because the law requires certain expenditures, i.e. doctors must treat individuals at the emergency room, and these expenditures tend to be quite large if incurred.
Social services in general could enjoy this type of innovation if funding were pooled between government services, and healthcare, housing, food, and direct welfare were all managed together. Currently, each is conceived as a separate welfare program, so one can only recognize reduction within a program, not how the programs interact. For example, it may be that the expansion of SNAP benefits would decrease emergency room visits and end up being cost-saving overall. It may also be that certain types of subsidized housing reduce the need for other services and are more cost-saving than others, but this is hard to recognize when each program is segregated. One could imagine that subsidized housing built in areas with better access to quality food and jobs would be more expensive upfront, but could save in money overall by reducing the need for other benefits. Because social services currently have a system of mandatory spending in the form of entitlements, there is an incentive to ensure that individuals transition away from use of the more expensive services.
There are many ways to drive medicine forward. One is to work to remove economic, political, or geographic barriers to accessing care, and thus aid those whose suffering can be assuaged but is not being so. Another is to work to develop treatments for types of suffering poorly eased (or addressed) by current care. Both are important. Serious pursuit of the second strategy, however, requires the participation of industry; to translate bench science into benefits for real people will usually require manufacture of new medicines or devices, a function that universities and public institutions do not do but industry does well.
But for those students, like myself, currently training in MD-PhD programs in hopes of pursuing this goal of translational medicine, it is not at all clear what attitude we should take towards industry. On the one hand, the vision to move science from bench to bedside would seem best served by those clinician-scientists who do not see publication as the end result but are devoted to responsibly guiding their discoveries into the industrial setting and propelling them to patients. On the other hand, connections between industry and academia are often described categorically as “conflicts of interest” that must be disclosed and ideally divested. I will not attempt to comment here on the events that have led to a prima facie (pharma facie?) negative valence of academic-industrial connections; I was struck to hear, however, one of the panelists (an academic) on a recent panel discussion on translational medicine open with a slow and measured statement affirming her belief that collaborations between academics and industry can be a “good thing.” She then paused, as if to let the shock of the statement permeate the audience.