Participants in the live webcast will have the opportunity submit questions and comments. Please do!
This month’s Regulatory Science Series presentation features Dr. Keith Joiner, MD, MPH, the Director of the Center for Management Innovations in Health Care at the Eller College of Management, and former Dean of the University of Arizona College of Medicine. He will present on NIH Efforts to Support Translational Science and discuss the importance of government funding policy to the regulatory science endeavor.
This event will stream live at 12:00 PM MT on Wednesday, October 14, 2015, at: https://streaming.biocom.arizona.edu/event/index.cfm?id=26072.
The University of Arizona Regulatory Science Program is a partnership with the James E. Rogers College of Law and University of Arizona Health Sciences.
This week, my colleague Derek Bambauer will speak as part of the Regulatory Science series at the University of Arizona. Free CLE attendance form and readings are available.
Tune in at 12:00pm (Pacific) / 3:00pm (Eastern) on Wed Sept 16.
The talk will also be archived at the same link.
Co-blogged with University of Arizona Fellow, Jonathan Loe
Breathlessly, many news outlets reported yesterday that Kim Kardashian West was in trouble with the FDA for misleading social media advertising of the drug Diclegis. For example, the reliably hyperbolic Daily Mail led with “Kim Kardashian slammed by FDA.”
As followers of this blog may not know, Mrs. Kardashian West is pregnant with her second child. Following on the disappointing news that the soon-to-be sibling of baby “North West” will not be named South, the celebrity-for-celebrity’s-sake shared a post on Instagram (and Facebook, and linked to from Twitter, naturally). The post announced for the world that “OMG” her “#morningsickness” had benefited from a prescription of Diclegis—with “no increased risk to the baby.” The FDA issued a warning letter, because the social media post failed to communicate any risk information.
But is the FDA really concerned with people, however famous, commenting on their personal experiences with drugs?
The answer is…
Over at the Health Affairs blog, I have a new post on industry funding of science, the power of disclosure, and alternative funding models for biomedical science. Check it out.
The New England Journal of Medicine (NEJM) spent the month of May with an artillery barrage against the idea that conflicts of interest in medicine are at all problematic, with a series of three longish opinion pieces (here’s one) by Lisa Rosenbaum, amounting to nearly 10,000 words of text overall, plus an editorial by Jeffrey Drazen. At the very least, this format and sheer commitment of pages signals that changes are on the horizon for NEJM, rolling back at least some of the 25-years of regulations about conflicts of interest. In substance, the papers careen between skepticism about whether commercial bias exists at all, and the cynical view that there is so much bias from so many commercial and non-commercial sources that resistance is futile.
This week, three former NEJM editors (Robert Steinbrook, Jerome Kassirer, and Marcia Angell) fire back from across the Atlantic in the BMJ. In the 1400 words allowed in the essay format, the rebuttal cannot meet the onslaught in sheer volume, but it does call out some of the excesses, including Rosenbaum’s strange suggestion that “honest debate” has been “stifled” and the sky-is-falling notion that regulation of COIs “prevent the dissemination of expertise.” If the Rosenbaum papers had been submitted to traditional peer review procedures, engaging subject-matter experts from the fields of psychology, law, and ethics, I think that the worst of these could have been avoided.
The BMJ authors also call out the burden-shifting on the core empirical questions about whether conflicts of interest are problematic and whether they can be effectively regulated. In my view, there is plenty of basic science research to show how COIs can create biases and undermine trust. The remaining questions are just cost-benefit analyses about how best to regulate.
I am not sure that I would follow the BMJ authors all the way to their own unqualified thesis that, “Put simply, financial conflicts of interest in medicine are not beneficial, despite strained attempts to justify them and to make a virtue of self interest.” The relationship between profit and health is contingent. In some instances, profit-seeking behavior does in fact promote health. When profit-seeking detracts from health, that’s when we need thoughtful regulation.
Do you know of a doctoral student or scholar who finished his or her last degree in 2009 or later, and who has produced excellent empirical research on the relation of law or legal practices to population health? If so, please consider submitting a nomination by December 10. It’s quick and easy.
Over at our sister blog for the Safra Center’s Institutional Corruption Lab, Paul Thacker has a great post about how the Physician’s Payments Sunshine Act came to exist. The new database created by the Act is just now going live, and its a good time to reflect on how we got here. Thacker was a staffer for Senator Chuck Grassley, and from that vantage, has rare insight into how the bill was conceived and how initial objections of Big Pharma were overcome. Thacker also outlines several complementary efforts, including pressure to reform NIH policies around conflicts of interest. That proposal went all the way to the White House, where it was gutted. Worth reading.
This single webpage (Vox) covers about 80% of what I try to convey during the first day of my health law class. And the page does it with some nice graphics, which are worth stealing (ahem, “fair using” for educational purposes). While nothing will be new to health policy scholars, it is a nice synthesis. Highly recommended.
Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents. In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.
Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?” This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:
Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.
[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.” This is the first installment in our series of live blog posts from the event; video will be available later in the summer on our website.]
Alan M. Garber is Harvard’s provost, and both an economist and a physician by training. He holds appointments in the medical school, the faculty of arts and sciences, the school of government, and the school of public health. [Perhaps I should have just listed the colleges that haven’t yet given him an appointment?] I’ll mostly just paraphrase Garber’s talk, and sparsely add my own comments in brackets [as I just did].
Garber’s talk is focused on the Affordable Care Act, and says that it has two purposes: expand access to care, and reduce the costs of care. The latter is particularly important, given the way healthcare is impinging on the larger United States economy.
As I prepare to teach the health law survey course here at HLS in the spring, I am putting together some exercises for students to work on “open questions” in the field. For example, I am thinking about tasking a group of students to explore ways that insurers could or already do structure their contracts with patients and providers to prevent pharmaceutical companies from using coupons to undermine cost-sharing burdens. (Medicare simply does so with the anti-kickback statute.) I have another question about whether the inventor of a new medical device could use crowd-sourcing (e.g,. kickstarter) to raise funds for product development, without running afoul of the FDA proscriptions on unapproved marketing. I would love to get your ideas about open questions in other areas, including bioethics, medical malpractice, public health law, scope of practice, etc. Please post them in the comments or contact me. I’m happy to reciprocate.
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.
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?”
This year, the PFC’s annual conference will focus on “Behavioral Economics, Law, and Health Policy” (the call for abstracts deadline is next week). Apropos, last week, Reuters featured a story by Jill Priluck “The Overselling of Behavioral Economics,” which itself seems to be a press release for a new article by NYU’s Rick Pildes and Ryan Bubb, called “How Behavioral Economics Trims its Sails and Why.” In several fields, including consumer finance, Pildes and Bubb chronicle examples where policymakers tried to put behavioral economics principles into practice, and seem to have failed to produce desired results or have caused unintended consequences. Some of their examples are controversial (in terms of both the interventions tried and the success of the outcomes), but those points are best addressed by the experts in those fields.
As health law considers its relationship to behavioral economics, I think a larger point is in order. Allow me to be provocative: there is no such thing as behavioral economics.
Instead, the core of what we have called “behavioral economics” is just a set of observations (usually from lab experiments) where idealized and assumption-laden economic models have failed to actually predict human behavior. At least at this stage of its development, behavioral economics is best understood as a negative project, not a positive one. Of course, we do put labels on those documented failures like “regret aversion” or “social norming” or “optimism bias,” and it is then tempting to make things out of those labels. Instead, when the limits of those simplistic economic models are found, that should simply return social scientists and policymakers to a domain of open-minded common sense about how people will actually behave when we take them outside the lab and try to regulate them.
While the behavioral economics literature does provide its own theoretical frameworks, which can generate new hypotheses, the best teaching of behavioral economics is simply fallibilism and empiricism. That is why the “Nudge Unit” (aka Behavioral Insights Team) in the United Kingdom has prioritized the use of randomized experimentation to evaluate every “nudge” that it tries, and the sister initiative here in the United States is doing likewise. I am optimistic of that approach.
Over at the Hoover Institute’s blog, Richard Epstein recently offered a scathing critique of the Obamacare rollout, making dire predictions about adverse selection that will lead to a “death spiral.”
[In defending the rollout, President Obama] hasn’t addressed the composition of the applicant pool, which clearly attracts individuals with known healthcare conditions who will receive extensive public subsidies to join the ranks of the insured. There is no way that the government exchanges can remain viable without attracting large numbers of healthy young persons, all of whom are well-advised to stay away in droves, until they become sick and can sign up with the plan of their choice, no questions asked. Obamacare can only remain solvent with an enormous public subsidy.
Today, the New York Times ran a story about the 360,000 Californians that have signed up for healthcare on its exchange, since it opened on October 1. The early enrollment results seem promising, suggesting that adverse selection and public subsidies are not so problemmatic:
Officials said 18- to 34-year-olds made up 22.5 percent of the nearly 31,000 Californians who selected a private health plan in October. The same age group makes up 21 percent of the state’s population. … People who did not qualify for a subsidy enrolled in significantly higher numbers than those who did. The state reported that 4,852 people who selected a private plan in October were eligible for tax credit subsidies, which are based on income, compared with 25,978 who did not qualify.
The new American Heart Association and American College of Cardiology guidelines on how patients should manage their cholesterol are likely to dramatically increase the sales of statins. (E.g., check out the bump to Pfizer’s stock price.) Yet, the new guidelines have become instantly controversial, with prominent cardiologists calling them into doubt. In addition to the substantive scientific dispute, there are also questions about whether the guidelines panel may have suffered from biases, due to conflicting interests. As PharmaLot reports:
Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medications. And among the half dozen who disclosed these relationships was one of the two panel co-chairs, which contradicts an Institute of Medicine suggestion about managing conflicts on such panels. Each of the six panelists disclosed they worked as a consultant and received funding for personal research. And among the 10 expert reviewers, half listed consulting relationships.
I, of course, do not know the right answer about statins on the merits. As a layperson, I must use proxies and heuristics to decide, and to some extent busy non-specialist physicians must do the same. That is the whole point of the guidelines — so that each individual physician does not have to review the science himself or herself. They are supposed to be able to simply rely on the guidelines, as the state of the art. Yet, the conflicts of interests undermine our confidence in the AHA/ACC guidelines, making them less impactful on our prior beliefs. (My own research has documented this sort of discounting, among both physicians and laypersons). That sort of discounting is perfectly rational.
Some have argued that it is unrealistic to find experts who do not suffer from such conflicting interests. But what if the AHA/ACC had just proceeded with the nine unconflicted panelists, and the five unconflicted reviewers? Regardless of whether the panel reached the same outcome, it might have then better served the bona fide interests of the AHA and ACC, as well as the interests of public health. If that panel did reach the same pro-statin outcome, which boosted Pfizer’s stock price, all the better.
Over at the Volokh Conspiracy, Jonathan Adler has a quick take on whether President Obama has legal authority for his decision to allow non-compliant health insurance policies to remain in effect. The White House has suggested that this is merely a routine question of enforcement discretion, just like prosecutors use everyday. (See e.g., AZ v. US, affirming this power under the immigration laws.)
Professor Adler asks, “Does this make the renewal of non-compliant policies legal?” And he at first answers, “No. The legal requirement remains on the books so the relevant health insurance plans remain illegal under federal law.” Adler suggests that this illegality may become important if, for example, a patient were to make an insurance claim under a non-compliant policy for a procedure that would have been covered under a compliant policy. Adler suggests that the Affordable Care Act (ACA) would force coverage, regardless of what President Obama says.
At the end of the post, however, Adler adds an update, which comes around to what I think is probably the better analysis. Under the Affordable Care Act, only compliant plans “may be sold on exchanges or satisfy the minimum coverage requirement (the individual mandate). So the [ACA] does not expressly prohibit insurance companies from offering such plans (assuming they are allowed by state insurance commissions).” Thus, they are not “illegal” in the first place. [UPDATE: Adler has updated his post a third time, citing 42 USC 300 gg-6, providing that insurers in the small group and individual markets shall ensure that such coverage complies with the essential health benefits package.]
In the end, the President’s new decision really does seem to be about declining to enforce the [proscription against these plans being offered] and declining to enforce the tax penalty on individuals that have non-compliant insurance policies. He is saying that, as far as the Federal Government is concerned, “if you like your policy, you can keep it” (for now).
Over at our sister blog for the Edmond J. Safra Center for Ethics, Gregg Fields has an insightful discussion of the way Obamacare has relied on private sector contractors to get its enrollment website up and running. Gregg quotes Safra-affiliate Bill English, who explains the allure of public-private partnerships: they “enable the public sector to harness the expertise and efficiencies that the private sector can bring to the delivery of certain facilities and services traditionally procured and delivered by the public sector.” HHS Secretary Kathleen Sebelius gets the understatement of the year award: “Unfortunately, a subset of those contracts for HealthCare.gov have not met expectations.”
The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science. There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings. (I am particularly enamored with this graphic, which shows the fundamental problem of inference.) It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail.
The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it. In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.
One of the beauties of our scientific system is that it is wildly decentralized. Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer. Likewise, journal editors can publish whatever they want. While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts. The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.
The problems are scientific, but any solution will be institutional (and thus legal). I have argued for a partial solution to industry bias in my short article, called “The Money Blind: How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.” Independent scientific testing could be conducted by a neutral intermediary, which would pool funds. In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.” This program offers to be the independent scientific agency, which attempts to validate known results. But there is not yet a large-scale funding model in place. If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable. And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.