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North, West, and the Direction of FDA Enforcement in the Social Media Age

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By Christopher Robertson

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…

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The Empire Strikes Back on Conflicts of Interest (COI) in Medicine

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By Christopher Robertson

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.

Open Payments: Early Impact And The Next Wave Of Reform

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This new post by Tony Caldwell and Christopher Robertson appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.

As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.

These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. […]

Continue reading here.

The Father of Sunshine

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Paul Thacker

By Christopher Robertson

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.

8 Facts (and some pretty graphs) that explain what’s wrong with American Healthcare

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By Christopher Robertson

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.

The Political Economy of Medicaid Expansion

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By Christopher Robertson

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:

Chart09-09-updated[1]

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.

#BELHP2014 Plenary 1, Provost Alan Garber

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Provost Garber at the Conf
Provost Garber at the Conf

By Christopher Robertson

[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.

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Open Questions in Health Law?

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By Christopher Robertson

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.