About crobertson

Christopher Robertson is a professor at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute. Professor Robertson's research focuses on how the law can improve decisions by individuals and institutions -- attending to informational limits, conflicting interests, and cognitive biases, especially in the domain of healthcare. Blending legal, philosophical, and empirical methods, Robertson's work has been published in the New England Journal of Medicine, New York University Law Review, Cornell Law Review, Emory Law Journal, and the Journal of Empirical Legal Studies. He has received research support from the Robert Wood Johnson Foundation, and runs the Law and Behavior Research Lab at the University of Arizona. Robertson graduated magna cum laude from Harvard Law School, where he also served as a Petrie Flom fellow and lecturer. He earned a doctorate in Philosophy at Washington University in St. Louis, where he also taught bioethics. For 2013-2014, he was a visiting professor at Harvard Law School, and will visit at NYU School of Law in 2016-2017. Robertson's legal practice has focused on complex litigation involving medical and scientific disputes.

Conflict of Interests Disclosures Come to PubMed

By Christopher Robertson

Scholars and policymakers have long been concerned that the biomedical science literature — and thus the practice of medicine — is biased by the companies who fund research on their own products.  Prior research has shown that industry-funded studies tend to produce results favorable to their company sponsors.  One solution is disclosure of industry funding, so that physicians and other consumers of the biomedical literature can weigh scientific findings accordingly.

My prior work with Aaron Kesselheim, Susannah Rose, and others has found that adding such disclosures to biomedical abstracts could make a big difference — physicians understand them and will rely upon them.  Nonetheless, most journals bury the disclosures at the end of articles, which are often hidden behind paywalls and not nearly as salient as the methods and findings displayed in the abstract.  For the Institutional Corruption Lab of the Edmond J. Safra Center, I worked with a team of hackers to create a browser extension that proves the feasibility of adding those disclosures into PubMed, a Federal government database of the scientific literature.

Thankfully, that browser extension is becoming obsolete, as the National Library of Medicine (part of the NIH) has begun implementing such disclosures themselves, right in PubMed.   A search reveals that nearly 80,000 abstracts now have such tags.  While a lot in absolute terms, it is a small minority of the 17 million abstracts covered by PubMed.  Commentators have suggested that as much as 70% of the funding for clinical trials comes from industry, so we should expect millions of abstracts to have such disclosures.

Thus we are still a long way from comprehensive and effective disclosure.  There are two problems. Continue reading

Another Way to Cut Medical Malpractice Damages?

To limit liability and increase predictability, scholars and policymakers have long focused on capping damages awards.  In particular, they have been worried that there are many runaway jury awards for non-economic damages (i.e., pain and suffering).  Because these are not based on tallies of medical bills or lost wages, these are the least predictable component of the jury’s award.   Still, statutory caps on damages effectively nullify the jury’s determination (and the trial judge’s oversight) of how much to compensate a plaintiff for pain and suffering.  The laws substitute an arbitrary maximum instead (which, in many states, has not adjusted with decades of inflation).

There is now a cottage industry of scholarship that tries to understand the effects of these state caps on payouts, the supply of physicians, liability insurance, economic damages awards, and the aggregate cost of medical care (which may decrease or increase).  (See a synthesis of the literature.)

In new work with John Cambpell and Bernard Chao, I study a different way to cabin jury awards for non-economic damages.  Rather than capping runaway awards ex post, some states have tried to prevent them in the first place, by manipulating what a jury hears in closing arguments.   Continue reading

National Survey Suggests that Off-Label Status is Material to Informed Consent

As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses.  (Companies are not allowed to promote off-label uses however.)

A recent national survey by Consumer Reports includes two interesting findings:

  1. About two-thirds (63%) of Americans “would not take a doctor prescribed medication that has been approved by the FDA, but not for their specific condition.”
  2. Almost all Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition.”

Patients are right to be skeptical of off-label uses, though they may not appreciate just how common they are.  In fact, most off-label use is unsupported by scientific evidence as to safety and efficacy.  A new report by the FDA illustrates several off-label uses that were subjected to rigorous clinical trials and turned out to be ineffective or dangerous.   For example, Aliskiren is approved for treatment of hypertension and was used off-label for prevention of congestive heart failure (CHF) complications.  A large trial showed that, although it did not significantly improve CHF mortality, it did significantly increase rates of kidney failure for CHF patients.  We do not know how many other off-label uses would fail if similarly tested.   Continue reading

The ACA’s Real Effect: Moving the Goalposts

By Christopher Robertson

“I believe and I look forward to working with you to make certain that every single American has access to the highest-quality care and coverage that is possible. … [W]e believe it’s appropriate to put in place a system that gives every person the financial feasibility to be able to purchase the coverage that they want for themselves and for their family.”

That quote is not from Barack Obama.  It’s from Trump HHS nominee Tom Price, and it shows just how successfully the ACA has shifted the American political landscape towards universal coverage. As I argued earlier this month in STAT, with Glenn Cohen and Holly Fernandez Lynch, the debate is now about how to get universal health insurance coverage, rather than whether to do so.

Republicans will of course favor market-oriented approaches, and they will find difficulty conceiving a plan that is farther to the right than the ACA itself while actually achieving the goals that Price promises.  But for now, even if the ACA is soon repealed, it has succeeded in moving the goalposts for health policy.

Income-Scaling of Cost-Sharing Gains Traction

With 148,000 members, the American College of Physicians (ACP) is the largest medical-speciality organization.  This summer, its board released a new report on the growing financial burdens faced by patients who enjoy health insurance but are nonetheless exposed to unbearably large costs for healthcare.  At the end of the day, cost-sharing is just the absence of insurance for those costs.

ACP calls for a range of reforms, including “income-adjusted cost-sharing approaches that reduce or directly subsidize the expected out-of-pocket contribution of lower-income workers to avoid creating a barrier to their obtaining needed care.”  As I have argued, the Affordable Care Act includes income-based subsidies for cost-sharing in the Marketplaces, but these are currently being challenged in court, and do not apply to the employer-based system or Medicare, which together cover the vast majority of patients.

Hillary Clinton has also advanced a plan to create progressive refundable tax credits for people who spend more than 5% of their income out-of-pocket.   The advantage of such a tax-based approach is that it reaches patients regardless of where they get their insurance (except for Medicare, which is excluded).  The disadvantage is that it leaves people in a state of financial insecurity until they get their refunds.  A better approach would scale cost-sharing exposure in the first place, a power that I have suggested is already available under Federal law and which is self-funding.

Fighting the Next Pandemic: Airline Vaccine Screens

Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several Flight routeshundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate.  Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.

We are (hopefully) not going to stop airline travel.  But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated.  That’s the thesis of a new paper out this week.

Airlines carry two million people every day.  And, prior research has shown that airline travel is a vector of disease.  In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.

The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden.  About 42,000 adults and 300 children die every year from vaccine-preventable disease.  New vaccines are on the horizon.

Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak.  Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.

Recent Developments in Off-Label Promotion

By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Continue reading

Webcast: Dennis on Precision Medicine and Cancer Pathology

The Regulatory Science Series at University of Arizona

presents

Eslie Dennis, MD,
Vice President and Head Global Medical Affairs Ventana Medical Systems, Inc., a member of Roche Group

speaking on 

“Cancer, Pathology, and Precision Medicine:  Virchow Revisited Through Grogan’s Lens”

Available live at 3PM Eastern Apr 6 and archived at https://goo.gl/NGEBPt

Bill Sage Webcast on Health Law v. Health Policy

As part of the Regulatory Science series at University of Arizona:
Health Law and Health Policy: A Frictional Account
William M. Sage, MD, JD, University of Texas
Today 12/2 — Noon (AZ Time) / 2pm Eastern / 11am Pacific
The talk will be webcast live, and available as an archive:

https://streaming.biocom.arizona.edu/event/index.cfm?id=26074

Participants in the live webcast will have the opportunity submit questions and comments.  Please do!

10/14: Webcast on the NIH’s Efforts to Support Translational Science

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.

Wednesday Webcast: “Gene Patenting, Innovation Incentives, and the Future of Intellectual Property” by Derek Bambauer

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.

https://streaming.biocom.arizona.edu/event/?id=26071

The talk will also be archived at the same link.

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

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…

Continue reading

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

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.

Call for nominations for an Outstanding Junior Scholars Award from RWJF’s Public Health Law Research Program

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.

The Father of Sunshine

Paul Thacker

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

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

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

Provost Garber at the Conf

Provost Garber at the Conf

[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.

Continue reading

Open Questions in Health Law?

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.