Year: 2016

Outpatient Psychiatric Treatment: The Duty to Prevent Patient Suicide

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By Alex Stein

In Chirillo v. Granicz, — So.3d —- (Fla. 2016), 2016 WL 4493536, the Florida Supreme Court formulated an important rule for psychiatric malpractice cases. Back in 2001, the First District Court of Appeal decided that psychiatrists assume no liability for an outpatient’s suicide because it is generally unforeseeable. Tort liability, it held, can properly be imposed on a psychiatrist only for a custodial psychiatric malpractice. According to the First District, an inpatient’s suicide is foreseeable and psychiatrists can effectively prevent it by restraining the patient. Lawlor v. Orlando, 795 So.2d 147 (Fla. 1st DCA 2001).

The Florida Supreme Court has now overruled Lawlor. Read More

Public Health under the Trump Administration

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By Wendy E. Parmet

The recent report by the National Center for Health Statistics showing a decline in life expectancy in the U.S. in 2015 highlights a point largely overlooked in post-election discussions about health policy under the Trump Administration. The significant increases in health insurance coverage under the ACA have not resulted in population-wide improvements in life expectancy. This is not because the coverage increases aren’t important; without question they have made a difference in the lives of millions. Rather, it’s because health care plays a relatively small role in determining population-level health outcomes.  More important are the so-called social determinants of health, the “conditions in which people are born, grow, work, live and age, and the wider forces and systems shaping the conditions of daily life.” This suggests that the new Administration’s economic, educational, environmental, labor, and housing policies will have more to say about the health of Americans than its proposals for replacing the ACA or reforming Medicare and Medicaid.

Public health policies, and public health law, can also have a major impact on population health. Several years ago, the CDC published a list of the “Ten Great Public Health Achievements in the 20th Century,” which it credited with adding 25 years to life expectancy in the U.S. The list included immunizations, control of infectious diseases, family planning, reductions in tobacco use, work-place and motor-vehicular safety and safer and healthier foods. These goals and other public health objectives, including reductions in opioid use and obesity, remain paramount to preventing further reductions in life expectancy.

To date, little attention has been paid to the incoming administration’s views on most of these issues. Although Trump has nominated Rep. Tom Price to be Secretary of HHS, he has yet to name his picks for the head of CDC or for Surgeon General. The Trump transition website does not mention public health; nor did many public health issues, other than the opioid epidemic, receive much notice during the election. Read More

Monthly Round-Up of What to Read on Pharma Law and Policy

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By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of November. The selections feature topics ranging from industry funding of cancer patient advocacy organizations, to the shared responsibility between the FDA and CMS, to active surveillance of follow-on biologics. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
  2. Bauer SR, Redberg RF. Improving the Accelerated Pathway to Cancer Drug Approvals. JAMA Intern Med. 2016 Nov. [Epub ahead of print]
  3. Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 Nov 29. [Epub ahead of print]
  4. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016 Nov 2. [Epub ahead of print]
  5. Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2016 Nov 12. [Epub ahead of print]
  6. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.

TOMORROW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

The Petrie-Flom Center Staff Leave a comment

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

Description

This symposium will bring together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels will cover:

  • Why payment is offered to research participants
  • Regulatory parameters governing payment
  • Whether payment to research participants should be considered exceptional, compared to payment in other contexts
  • How offers of payment affect participants
  • How to define coercion and undue influence with regard to paying research participants
  • Which factors should be considered when evaluating proposed payments
  • The problem of low payment

This event is free and open to the public, but space is limited and registration is required. Register now!

Working Agenda

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Westworld and Bioethics

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By I. Glenn Cohen

[WARNING: Spoilers below]

On Sunday, HBO’s Westworld finished its run. Though I thought some of the early episodes were arguably a bit of a failure as television (and my partner almost jumped off the bandwagon of making this one of “our shows”) IMHO the show finished very strong.

But whatever you thought of it as television, the show is wildly successful at raising a series of bioethics issues. There have been a bunch of other very good treatments of some of these issues in the last couple of decades – A.I., Ex Machina, Humans, Battlestar Galactica all come to mind – that touch on some of these issues. But, what I loved about Westworld is its lack of direct moralizing on these subjects, and how it leaves the viewer puzzling through them in a much more naturalistic way: I have been thrust in this unfamiliar world, and now I am trying to use my ethical compass to get my bearings.

Once upon a time I discussed Bioethics and the Martian, and my aim is to do the same here. I thought one way to share why I think the show is so successful as a text for bioethics exploration was to develop a “mock exam question” on the subject. This is really written more like an oral exam, with follow-up questions. The goal is not entirely fanciful since I do teach a course that uses films as texts to explore bioethics and the law.

Here goes: Read More

DNA: Donors Not Anonymous

The Petrie-Flom Center Staff Leave a comment

Special Guest Post by Wendy Kramer
[In response to Sperm donor anonymity and compensation: an experiment with American sperm donors, published in the Journal of the Law and Biosciences.]

My son Ryan and I were contacted by Family Tree DNA in 2004, as they thought that their new commercial DNA testing capabilities might be useful to Ryan, and to the others in our community of donor conceived people at the Donor Sibling Registry. At that time we thought it might be possible to find out more about one’s ancestry and countries of origin. Ryan was excited to learn more about his “invisible” paternal ancestry, so quickly agreed to swab his cheek, send in his sample and see what he might learn. He may have been the first donor-conceived person to throw his DNA into a public DNA database, making himself available to connect with previously unknown genetic relatives.

At first, he did learn a bit more about his paternal ancestry, specifically about countries of origin. He learned that he was mostly English, with some Irish and even a bit of Icelandic (which he thought was pretty cool). He also matched with people on his 12 and 25 Y Chromosome DNA markers, which meant that common ancestors related them from hundreds or even thousands of years ago. And for 9 months he was content with that little bit of information. Read More

New Hastings Center Special Report – NFL Player Health: The Role of Club Doctors

The Petrie-Flom Center Staff Leave a comment

On November 21, 2016, the Law & Ethics Initiative of the Football Players Health Study at Harvard University, led by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, published a Special Report in the Hastings Center Report, entitled NFL Player Health: The Role of Club Doctors. The Special Report consists of multiple parts.

First, the Special Report includes the Law & Ethics Initiative’s main article, entitled A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player Trust. This article focuses on the principal recommendation of our recent report, Protecting and Promoting the Health of NFL Players: Legal and Ethical Analysis and Recommendations, for addressing the conflicts of interest inherent in the current structure of NFL player healthcare, in which club medical staff provide services to both the club and players.

The article proposes to “resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient.” Specifically, club physicians would be replaced by two sets of medical professionals: the players’ medical staff, with exclusive loyalty to the player, and the club evaluation doctor, with exclusive loyalty to the club. Read More

Will Medicare Reform be a Republican Obamacare?

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By Shailin Thomas

As the health care community waits with bated breath to see what will become of the Affordable Care Act under the Trump administration, Republicans in Congress have set their sites on another health-related initiative that has been on their wish list for years: reforming Medicare. While Trump promised throughout his campaign not to change the fundamental ways in which Medicare works — in part to appeal to older voters, who overwhelming would like the program to stay as it is — shortly after the election, “modernizing Medicare” appeared as a priority on the transition website for the new administration.

The reform many Republicans are pushing for — championed by Speaker of the House Paul Ryan (R-WI) — is privatization along the lines of Medicare Advantage. Instead of providing for full insurance coverage through the government, as traditional Medicare currently does, Ryan’s proposal would have eligible patients purchase insurance from private companies with financial assistance from the government. The theory is that by having private insurers provide coverage, Medicare will capture efficiencies of the private market, while simultaneously offering consumers more choice in the coverage they receive.

After Paul Ryan first unveiled this plan in 2011, the Kaiser Family Foundation released a report detailing the significant fiscal problems with this “modernized” vision of Medicare. According to the Foundation’s analysis, the average out-of-pocket expense for beneficiaries increase from $5,630 under the current system to $12,500. The reason for this increase, according to the Congressional Budget Office, is that providing coverage is actually more expensive for a private insurer than it is for the government.  The proposal faces other economic challenges as well, and ironically, some of them stem from its close resemblance to Obamacare.

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Unified Patents and Brexit: Britain’s Back on Board

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By Seán Finan

After several failed attempts, years of protracted negotiations and a glacial ratification process, it seemed as if Brexit would finally put an end to the nascent European Unitary Patent. Last week, however, the UK confirmed its intention to ratify the Unified Patent Court Agreement and to move forward with the plans for the creation of a single European Patent. If the UK goes ahead, the agreement would only be a German ratification away from coming into force. This means that we could see a single European patent by 2017.

So, what is the European Unitary Patent? How would it interact with the current patent regime in the EU? What would its introduction mean for the future of pharma and biotechnology in Europe?

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What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?

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By Rachel Sachs

Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here to put some of these concerns more plainly (and more bluntly), by asking a simple question: what is the right number of unsafe or ineffective drugs for the FDA to approve? I would like to hear the Act’s supporters answer this question. Below, I offer some thoughts of my own on how we should think about and evaluate this question.

More generally, when we think about FDA approval of new pharmaceuticals, we have to consider how the FDA should balance Type I and Type II errors. You may think the FDA ought to focus on minimizing the number of unsafe or ineffective drugs that it approves (minimizing Type I errors). After all, we don’t want the FDA putting its stamp of approval on drugs that harm patients or that don’t work. Over time, this would lead to an erosion of public trust in the FDA as a tool for consumer protection. More generally, this is the entire reason we’ve given the FDA its powers to begin with. Scandals involving unsafe or ineffective drugs prompted Congress to give the FDA more, greater powers over the years, in large part to prevent such products coming to market in the first instance.

Instead, you may think that the FDA should focus on minimizing the number of safe, effective drugs it fails to approve (minimizing Type II errors). In other words, it is worse for the FDA to deny patients access to a drug that is safe and effective than it is for the FDA to approve a drug that later turns out to be unsafe or ineffective. On this view, the FDA should still perform some screening against drugs with significant safety signals or against drugs with no plausible mechanism of action, and perhaps should require post-market surveillance studies, but the FDA ought to be enabling sick patients to access drugs more quickly. This view of the FDA’s role places greater responsibility on insurers, physicians, and patients to gather, process, and act on information about a drug’s safety and efficacy.

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