Remembering Alan Wertheimer

By Emily Largent

A week ago, I received the sad news that Alan Wertheimer had passed away. Alan made many important contributions to the philosophical literature, including Coercion and Exploitation. And while Alan would tell you that he did not identify as a bioethicist, he made significant contributions to the bioethics literature as well. I am certain his work will continue to be influential in many areas.

On a personal note, Alan was a mentor and friend. I truly appreciated his intellectual generosity and his many kindnesses toward me.

I met Alan while I was a pre-doctoral fellow in the Department of Bioethics at the NIH. My initial impressions of him were shaped by the vivid and incisive hypotheticals he offered for our consideration; the pointed questions he asked in the Department’s Works in Progress sessions (which have a reputation for “combative collegiality”); the thoughtful and rapid comments he made on manuscripts; and a surprisingly competitive bowling outing that Alan took with the Department of Bioethics fellows.

Our first project together was a survey of IRB members’ attitudes toward coercion and undue inducement. He often reminded me that it was his first survey – as it was mine – and that we would figure it out together (with help from Christine Grady and Frank Miller). The sense of camaraderie Alan fostered, despite the vast difference in our subject-matter expertise, put me at ease and made the project very enjoyable.

After I began grad school, I enjoyed occasional visits with Alan but relied largely on our correspondence to exchange updates on our families, to get feedback on my projects, and to seek Alan’s guidance. In response to my emails, it was not unusual to get either (a) insightful feedback or (b) an email telling me that he was at a bridge tournament. If it was (b), I knew that a second email with insightful feedback would be forthcoming.

I am, in hindsight, embarrassed to admit how unaware I initially was of the magnitude of Alan’s intellect and intellectual contributions. My appreciation for the personal interest he took in my ideas and projects is even deeper in light of what I know now. It says something about the special, and especially generous, colleague that Alan was. He will be missed.

Quality Measures and Doctor Behaviors

by Vadim Shteyler

Efforts to improve health care quality under the ACA have been directed towards expanding EHR use and health IT, improving care delivery by promoting care coordination and population health, and laying incentives for providers to meet quality measures. The 33 ACO quality measures include 8 measures to evaluate preventive care, 12 measures to address goals of managing 4 common diseases, and 7 to assess patient satisfaction. Though quality improvements have not been consistently shown, studies have found modest Medicare spending reductions. In fiscal year 2013, CMS began reducing health care reimbursement rates to hospitals with excessive 30-day readmission rates, as generalized by their readmission rates for heart attacks, heart failure, and pneumonias. These were extended to include readmission rates for hip and knee surgeries in fiscal year 2015. And, as readmissions were estimated to account for $17.5 billion of Medicare costs in 2012 (in part attributable to insufficient discharge services, access to outpatient care, and follow-up), efforts to curb them are expected to continue.

The ACO quality measures have been criticized for being too process oriented (as opposed to outcomes oriented). And, undoubtedly, so few quality measures can’t encapsulate all of health care. Noted shortcomings of readmission rates as a valid indicator of quality include that they do not differentiate between planned and unplanned readmissions and they don’t adequately control for different case-mixes between hospitals. As psychiatric illness is often poorly recorded in medical records, it is a major confounder that may impact different hospitals differently. In this blog post, I add the speculative concerns of a medical student from limited experiences on the wards. Continue reading

Mainstreaming Medical Legal Partnerships (MLPs)

Last week, I had the opportunity to speak at the 10th Annual Summit of the National Center for Medical Legal Partnership in McLean, Virginia. The summit brought together more than 400 people working to “mainstream” medical legal partnerships (MLPs). The theory of change is that through these partnerships, the health care sector can begin to more systematically address social, behavioral and environmental determinants of health. Particularly on behalf of patients who are low-income, legal professionals address root causes of illness by working with utilities companies, landlords, social service agencies and the court system.

Concretely, MLPs are programs in which civil legal aid agencies, health care organizations and public health departments cooperate to train their staffs, treat individuals and identify population level problems. Most often, it is civil legal aid agencies that provide expertise in the laws around housing and public benefits, and spend their resources to ensure access to housing subsidies, food benefits, health insurance and employment. Some law firms also contribute pro bono time to the cause, as do some law schools in the form of clinics.

Continue reading

Bioethicist Art Caplan: German Mom Expecting Quads at 65 is ‘Irresponsible’

A new piece by contributor Art Caplan on NBC News:

Berlin school teacher Annegret Raunigk is proudly prolific and, at age 65, not done making babies — pregnant with quadruplets that would enlarge her family from 13 to 17 children. Why?

Raunigk said she became pregnant again because her 9-year-old daughter asked for a younger sibling. (Her first 12 children — by five men — are ages 22 to 44). She told German tabloid Bild that donated eggs were fertilized and implanted at a clinic in Ukraine. Multiple attempts were required to get the eggs to fertilize. She did not say whose sperm was used or if the egg donor was paid.

Some media outlets have trotted out the usual fluffy descriptions of “miracle” and “gift” while trying to figure out if she is the oldest woman ever to have a child (she isn’t) or to have quadruplets (almost certainly she is). But this line of reporting completely misses the mark.

What she is doing is unethical. […]

Read the full article here.

Limiting D&E Abortions:  The Kansas Maneuver

Anti-abortion groups have found another way to limit previously legal abortions.  Building on the analysis in Gonzales v. Carhart, the 2007 case upholding the federal partial birth abortion law, Kansas has now prohibited “dismemberment” of fetuses.  This law would ban dilatation and evacuation (D&E) of the uterus by banning piecemeal removal of fetal parts, which is the standard way of performing second trimester abortions.  Several other states have similar legislation in the pipeline.

While 90% of abortions occur in the first trimester when suction aspiration or medication abortions are available, most later abortions occur by D&E, which involves several passes into the uterus with forceps or other instruments to remove the fetus.  The fetus is ripped apart and removed piecemeal.  The Kansas law would require that the fetus first be killed in utero by a KCL injection, and then removed piecemeal.  Alternatively, labor could be induced so that a very early nonviable fetus is delivered whole and dead.  If it is breathing, it is then not resuscitated because it is too immature to survive. Continue reading

Arizona Enacts “Abortion Reversal” Law

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On Wednesday, March 25, Arizona legislators passed a bill prohibiting women from buying insurance plans that cover abortions on the federal health exchange.  Senate Bill 1318 also includes a provision on medical abortions, which are typically used during the first nine weeks of gestation. Medical abortions involve taking two pills within a few days of each other.  The law requires doctors performing such abortions to tell their patients that if they reconsider their abortion after taking their first pill, they should return to the doctor for a procedure that can allegedly “reverse” the abortion.  The law amends Arizona Statute § 36-2153 to add that at least twenty-four hours before an abortion is performed, the physician must orally and in person inform the woman that “it may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” The law also requires the Department of Health Services to update its website to include information about the potential ability to reverse a medical abortion.  Republican Governor Doug Ducey, who opposes abortion rights, signed the law on March 30, 2015.

Like any law addressing abortion, the law is controversial. Abortion opponents lauded the bill, stating that Wednesday, March 25th was a “great day for women in Arizona who are considering getting an abortion to get all the facts they need.” On the other hand, women’s rights and health care providers’ groups oppose the coverage exclusion and vehemently oppose the abortion “reversal” provisions.  Senate Minority Leader Katie Hobbs called it “junk science” and “quack medicine.”  Arizona-based gynecologist Ilana Addis stated that there is no evidence to support this provision and women would essentially be “unknowing and unwilling guinea pigs.” Continue reading

Fraudulent Concealment and the Statute of Repose

By Alex Stein

Anyone interested in the tobacco litigation and/or medical malpractice must read Hess v. Philip Morris USA, Inc., — So.3d —- (Fla. 2015). Stemming from the Engle class action, this decision of the Florida Supreme Court advances the understanding of statutes of repose and how they apply, inter alia, in medical malpractice cases. Continue reading

Building on 20 Years of Success: The Future Role of Law

By Scott Burris, JD

On this, the last day of National Public Health Week 2015, we’re looking forward by looking backward. There is nothing new about using law and policy to promote healthier environments, products and behavior. There is no good future for public health that does not include even more, and more effective, legal interventions.

Evan Anderson and I wrote in 2012 about the legal regulation of health-related behavior over the past half-century. The story we told offered several reasons for unabashed optimism about what law can do for health. The record is clear that law works, and works across a wide range of different health threats. We pointed to CDC lists of Great Public Health Achievements from the last century and the first decade of the 21st.   Every one of them — from high levels of vaccination, through motor vehicle safety and cancer prevention to maternal and child health – could not have been successful without law and policy. Continue reading

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy: Prospect of Disease-Free Children for Women Carriers through MRT

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA gives rise to a broad range of heritable clinical syndromes. Cure of those affected remains out of reach. However, recently developed Mitrochondrial Replacement Therapy (MRT) – sometimes known as “three-parent IVF” — has raised the prospect of disease-free progeny for women carriers.

In the UK, legislation regulating the clinical application of MRT has recently been approved by the House of Commons and the House of Lords, after a 10-year process.

In the United States, the vetting of MRT, underway for a year, remains a work in progress. A new paper in Science released Friday, April 10, compares and contrasts the regulatory history of MRT in the UK and the United States, discusses the relevant ethical overlay, examines potential lessons learned, and charts the likely path forward in the United States. It is written by I. Glenn Cohen, Harvard Law Professor and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Eli Adashi, Professor of Medical Science at Brown University; and Julian Savulescu, Uehiro Chair in Practical Ethics at Oxford University and Director of The Oxford Centre for Neuroethics.

“There is much FDA and the U.S. can learn from the way in which the U.K. has evaluated and regulated MRT,” said Professor Cohen. “These lessons are particularly important because MRT is just one of a series of new reproductive and genetic technologies, including gene editing and In Vitro Gametogenesis, that FDA and regulators across the world will soon be confronting.”

Read the full paper now on the Science website.

The Brocher Summer Academy 2015: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy 2015 will address a much controversial topic: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy on Ethical, Legal and Social Issues (ELSI) in Assisted Reproductive Technologies (ART) brings together distinguished professors from different disciplines and countries and highly promising researchers willing to acquire a strong background on a ELSI in ART. It gives the participants a rare opportunity to meet personally and exchange ideas with many established international professors in an intimate and collegiate atmosphere.  The sessions take place at the Brocher Centre in Geneva, Switzerland in an amazing and peaceful environment on the shore of the Lake of Geneva.

Deadline for applications: 30 April 2015

Further information is available at:  Posted in Events, Reproductive Technology, Timo Minssen | Tagged , , | Leave a reply

Symposia at the Brocher Foundation in Switzerland

Dear colleagues,
Do not miss this splendid opportunity to get support for organizing symposia at on of the most beautiful spots in Europe:

Symposia

The Brocher Foundation is inviting junior and senior researchers to submit proposals for a 1.5 day multidisciplinary symposium project on the Ethical, Legal and Social Implications of new medical developments.

The Brocher Foundation will host and support the costs of the event between February and April or between July and October 2016.

The fully equipped Brocher Center Conference room – situated in Hermance, 15 kilometers from Geneva downtown, can welcome up to 60 participants in its exceptional location on the shores of Lake Geneva.

Excepted the travel reimbursements which will be directly arranged by the organizers, the Brocher Foundation will be responsible for all the logistics, according to its standard.

The call will end on the 17 May 2015 at midnight GMT.

Further information is available at:  Posted in Environment, Events, Timo Minssen | Tagged , | Leave a reply

Workshops at the Brocher Foundation

Dear colleagues,
Do not miss this splendid opportunity to conduct and discuss biomedical and legal research at on of the most beautiful spots in Europe:
Workshops
The Brocher Foundation is inviting junior and senior researchers to submit proposals for a 2 to 3 day multidisciplinary workshop project on the Ethical, Legal and Social Implications of new medical developments.

The Brocher Foundation will host and support the cost of the event between 2 May and 30 June 2016 or between 2 November to 16 December 2016, or between 9 January and 27 January 2017 at the Brocher Center.

Excepted the travel reimbursements which will be directly arranged by the organizers, the Brocher Foundation will be responsible for all the logistics, according to its standard.

The call will end on the 17 May 2015 at midnight GMT.

Further information is available at:  Posted in Timo Minssen | Tagged , | Leave a reply

Making Connections & Collaborating for the Future of Public Health

As part of the Public Health Law Research program’s participation in National Public Health Week 2015, we have been sharing materials and resources under the daily themes. Today’s theme, Building Broader Connections, is about expanding partnerships and making connections to benefit public health.

We spoke with Laura Hitchcock, JD, Policy Research & Development Specialist for Public Health – Seattle & King County and the King County Executive/Department of Executive Services Partnerships Initiative Lead. We asked her to offer some insight from her work as a lawyer and researcher in a public health department.

PHLR: What role can researchers play in building partnerships with health departments and contributing to the policy-making discussion?

Laura Hitchcock, JD

Laura Hitchcock, JD

LH: Public health researchers can help to support development and refinement of evidence-based policies. Because policies are created in a political process, it is important for public health departments to continue to offer their scientific knowledge to support creation of effective policies, including repeal of ineffective policies or refinement of existing policies to better result in a healthy population by 2030. Health departments may need help to define local or state-focused areas for policy evaluation by working together with researchers, and should contribute to development of research agendas by identifying areas where policy makers, communities, medical professionals and others have concerns about the public’s health, and are likely to need support from researchers to know how to ‘plug in’ to research agenda development. Continue reading

TOMORROW at 12PM: Moral Decisions in the Law: What’s the Brain Got to Do with It?

Moral Decisions in the Law: What’s the Brain Got to Do with It?

brainscan_colored_slide_270_174_85April 8, 2015 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3019
1585 Massachusetts Ave.
Cambridge, MA [Map]

Law – particularly criminal law – is infused with moral judgment and calls upon prosecutors, judges, and jurors to make morally-informed decisions. But where does morality come from? How do we “do” moral decision-making? Come join experimental philosopher and neuroscientist Fiery Cushman for a fascinating and provocative discussion of the current state of neuroscience research on morality. Dr. Cushman will present his computational models of learning and moral decision-making to describe how we learn what morality is within our own cultures, how we internalize moral rules, and how we make moral judgments about others. Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience at the Petrie-Flom Center and the Center for Law, Brain, and Behavior at Massachusetts General Hospital, will respond.

This event is free and open to the public. Lunch will be provided.

 Part of the Project on Law and Applied Neuroscience.

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

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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March.  The selections feature topics ranging from the reporting compliance of trial results to ClinicalTrials.gov, to the impact of risk evaluation and mitigation strategy-mandated medication guides on patient knowledge, to the cost-effectiveness of the novel hepatitis C virus medications.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015 Mar 12;372(11):1031-1039.
  2. Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015 Mar 17;313(11):1163-1165.
  3. Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med. 2015 Mar 19;372(12):1171-1175.
  4. Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes. Drugs. 2015 Mar 31. [Epub ahead of print]
  5. Knox C, Hampp C, Willy M, Winterstein AG, Pan GD. Patient understanding of drug risks: an evaluation of medication guide assessments. Pharmacoepidemiol Drug Saf. 2015 Mar 23. [Epub ahead of print]
  6. Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med. 2015 Mar 17;162(6):407-419.
  7. Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J. Catalyzing the critical path initiative: FDA’s progress in drug development activities. Clin Pharmacol Ther. 2015 Mar;97(3):221-233.
  8. Sarpatwari A, Choudhry NK, Avorn J, Kesselheim AS. Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 2015 Mar 17;12(3):e1001802.
  9. Weissman JS, Westrich K, Hargraves JL, Pearson SD, Dubois R, Emond S, Olufajo OA. Translating comparative effectiveness research into Medicaid payment policy: views from medical and pharmacy directors. J Comp Eff Res. 2015 Mar;4(2):79-88.

A New Cholesterol-Lowering Drug at What Price?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

This summer, the Food and Drug Administration (FDA) is expected to approve the first entries in a new class of drugs that lower patients’ low-density lipoprotein (LDL) cholesterol levels by more than half, even those patients who are already taking other cholesterol-lowering medication. The new drugs are biologics—monoclonal antibodies—that target, and inhibit, the gene proprotein convertase subtilisin–kexin type 9 (PCSK9). In mid-March, the New England Journal of Medicine published the results of important studies (here and here) of the two PCSK9 inhibitors that the FDA is expected to pass judgment on this summer. These studies—of Repatha (evolocumab), which is sponsored by Amgen, and Praluent (alirocumab), which is sponsored by Sanofi and Regeneron—suggest, but do not definitively establish, that PCSK9 inhibitors will reduce not just LDL levels, but also a patient’s chance of a major cardiovascular “event”, like a heart attack or stroke.

The race to approval between Amgen and Sanofi and Regeneron has been dramatic. (Pfizer also has a monoclonal antibody PCSK9 inhibitor in development, but it has lagged behind the two leaders.) As John Carroll reported at FierceBiotech last summer, Sanofi and Regeneron jumped ahead of Amgen when they purchased a priority review voucher from BioMarin for $67.5 million dollars. BioMarin was awarded the priority review voucher, which shrinks the time the FDA takes to approve a drug from ten months to six, because it developed and sought approval for a treatment for a rare pediatric disease. Per the Wall Street Journal, “[t]he voucher was the first to be issued under the pediatric incentive program, and also the first to change hands.”

As I mentioned earlier this week here, speculation has begun about what the price of the new PCSK9 inhibitors will be. Weighing in favor of a high price, the evidence of their efficacy is impressive and growing. The drugs hold particular promise for patients who cannot tolerate statin medications, or whose cholesterol cannot be controlled by statins alone. And, they are biologics, which are more expensive to produce than small-molecule drugs. On the other hand, PCSK9 are not without safety concerns. In addition, patients will have to inject themselves with the new drugs, which some will find undesirable (although some might prefer a once- or twice-a-month injection to a daily pill regimen). Finally, the new drugs will have to compete with generic statins.

Payers are very concerned. Continue reading

NEXT WEEK (4/8): Moral Decisions in the Law: What’s the Brain Got to Do with It?

Moral Decisions in the Law: What’s the Brain Got to Do with It?

brainscan_colored_slide_270_174_85April 8, 2015 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3019
1585 Massachusetts Ave.
Cambridge, MA [Map]

Law – particularly criminal law – is infused with moral judgment and calls upon prosecutors, judges, and jurors to make morally-informed decisions. But where does morality come from? How do we “do” moral decision-making? Come join experimental philosopher and neuroscientist Fiery Cushman for a fascinating and provocative discussion of the current state of neuroscience research on morality. Dr. Cushman will present his computational models of learning and moral decision-making to describe how we learn what morality is within our own cultures, how we internalize moral rules, and how we make moral judgments about others. Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience at the Petrie-Flom Center and the Center for Law, Brain, and Behavior at Massachusetts General Hospital, will respond.

This event is free and open to the public. Lunch will be provided.

 Part of the Project on Law and Applied Neuroscience.