New article on managing inherent conflicts in human subjects research

“In Plain Sight: A Solution to a Fundamental Challenge in Human Research”
Journal of Law, Medicine, and Ethics, Forthcoming (Lois Shepard and Margaret Foster Riley, UVA)

From the abstract: The conflict of interest created when physician-researchers combine medical research and treatment is a long-standing and widely recognized ethical challenge of clinical research that has thus far eluded satisfactory solution. A researcher’s obligation to the scientific enterprise not only provides the temptation to ignore the medical needs of subjects in a study, it may provide an obligation, short of actually endangering subjects, to override their medical needs or preferences. Expecting research subjects to protect themselves through informed consent processes is unrealistic, as is expecting physician-researchers to internally navigate this conflict simply by being virtuous. The problem is a structural one that requires a structural solution. People who are receiving medical treatment need a doctor devoted to their care to provide the independent, individualized judgment and advice expected of a physician outside of research. Reliance on other, existing protective mechanisms — institutional review boards, data safety monitoring boards, medical monitors or even the new research subject advocacy programs — falls short, as indeed each of those mechanisms assumes that the subject will be protected and advised by the local investigators, a role they cannot fulfill. For these reasons, we propose that in much clinical research, each research subject should have a doctor independent from the research study.

Upcoming Event – Health Care Reform: A View from Both Sides, 9/25/12

Tuesday, September 25, 2012
Austin Hall, Classroom 111
Harvard Law School

If you’re going to be in Cambridge next week, please join us for a special off-the-record debate on American health care reform, moderated by the Petrie-Flom Center’s Founding Faculty Director, Einer Elhauge.  John McDonough, official surrogate of the Obama campaign and director of the Center for Public Health Leadership at the Harvard School of Public Health, and Oren Cass, domestic policy director for the Romney campaign, will discuss what each candidate would mean for the future of US health policy.

This event is free and open to the public.  No reporting will be permitted without the express permission of the speakers. Lunch and refreshments will be served.

Co-sponsored by the Petrie-Flom Center, HLS Democrats, HLS Republicans, and HLS American Constitution Society.

Treatment of Subject Injury: Fair is Fair

By Suzanne M. Rivera, Ph.D.

Of all the protections provided in the Common Rule to safeguard the rights and welfare of research participants, there’s one glaring omission: treatment of study-related injuries.

Our current regulatory apparatus is silent on whether treatment of injuries incurred while participating in a study ought to be the responsibility of the sponsor, the researcher, or the test subjects.  The closest thing to guidance we are given on this topic in the Common Rule is a requirement that, if the study involves more than minimal risk, the informed consent document must provide, “an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.”

Note, the regulations do not state that plans must be made to provide treatment at no cost to the participants.  In fact, the regulations don’t say treatment needs to be made available at all.  Thus, it is possible to comply with the letter and spirit of the regulations by stating the following in an informed consent document, “There are no plans to provide treatment if you should be injured or become ill as a result of your participation in this study.”  Or even, “The costs of any treatment of an injury or illness resulting from your participation in this study will be your responsibility.” Read More

Conscientious Actions and Refusals

Great new Perspectives piece by Lisa Harris out in NEJM on the need to recognize that conscience can compel action, not only refusals to provide certain types of care (including abortion).  Elizabeth Sepper makes a similar argument in her forthcoming article in the Virginia Law Review.

First,  let me just say that I couldn’t agree more – it is essential to recognize both sides of the coin.  As I’ve argued elsewhere, both ought to be respected and protected, to a point, but the issues raised by conscientious refusal versus conscientious action are distinct in some important ways.  The primary problem with refusals is that they can burden patients by creating barriers to care, if not managed appropriately.  On the other hand, conscientious action would make care available to patients – and what could be wrong with that?

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California Surrogacy Bill Reacts to Lawyer Bad Acts

[posted on behalf of Judy Daar]

Mishaps in assisted reproductive technologies (ART) breed public outcries and legislative hand-wringing.  It is no wonder a 2011 San Diego-based ART debacle dubbed “an international baby-selling ring” caught the attention of the California legislature.  In a state where elected officials practically swear fealty to the mantra, “there ought to be a law,” the conviction and imprisonment of a prominent attorney who ran a gestational surrogacy agency gone awry was bound to garner lawmaker attention.  The resulting sausage, A.B. 1217, passed legislative muster last week and now awaits signature or veto by Governor Brown.

The story of A.B. 1217 is far more elaborate than the typical sequence of mishap to measure that often accompanies ART blunders.  In California alone, our codes are peppered with laws reacting to all manner of ART black eyes, including the egg-swapping scandal at the UCI Center for Reproductive Health in the mid-1990s, the luring of egg donors by big money pay outs and the criminal mishandling of trust funds supplied by intended parents in surrogacy arrangements. Overwhelmingly, these laws are dormant but their enactment expressed the public’s outrage when third parties manipulated and mishandle the birth of an assisted conception child.

A.B. 1217 is likewise designed to forestall a perceived evil – the selling of ART offspring, a noble enough cause. But the bill began its legislative life in February 2011 as a behemoth “kitchen sink” overhaul of ART law in the Golden State.  The 34-page bill regulated all manner of assisted reproduction, sometimes for the better (defining “infertility” for purposes of state mandated health insurance as “the desire to achieve pregnancy by means other than sexual intercourse” – thus, growing the coverage pot for single and same-sex parents), and sometimes for the worse (requiring anyone using ART to undergo a mental health consultation – implying that infertility itself is a psychological impairment and burdening couples who just need a little help reproducing using their own gametes with an intrusion not visited upon those able to reproduce naturally).

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Is the Self Defense Exception Consistent with the Belief that a Fetus is a Person?

In Glenn Cohen’s first post on this blog, he questioned whether Mitt Romney’s position on abortion was coherent with respect to the rape and incest exception, but did not question the self-defense exception itself.  He addressed the self-defense exception briefly: “Through the well-known doctrine of self-defense, the criminal law has long recognized that an individual may be justified in killing to protect his or her own life, or possibly health, and these exceptions merely reflect a similar view as to fetuses.”  He is correct to say that this is the established position, one that dates at least as far back as the Talmud.  But, assuming one believes that the fetus is a person entitled to the full panoply of rights, is the self-defense exception defensible?

Lethal self-defense is generally legally justified when used to protect your life.  This is even true in cases where the attacker is not morally culpable. Judith Jarvis Thompson, in her article entitled “Self Defense,” argues that this is true because they will “otherwise violate your rights that they not kill you.”  She then extends the rights of self-defense to third parties arguing that the rights are not personal (agent-relative).

Additionally, in the article “A Defense of Abortion,” Judith Jarvis Thompson argues forcefully against the position that abortion should be impermissible even when the mother’s life is at risk. This position is untenable from the perspective of the mother because “[i]t cannot seriously be said that . . . that she must sit passively by and wait for her death.”  In the abortion case, it follows that a third party (doctor) has the right to save the mother’s life as well.  I find this to be a convincing argument against the position that abortion should never be allowed.  But does it establish that every time the health of the mother is at risk she has the right to abort the fetus, killing a person?

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Is FDA’s 2013 Budget At Risk?

By Patrick O’Leary

Back in February, President Obama’s FY 2013 budget authorized $4.5 billion for the Food and Drug Administration (FDA), about $2 billion of which was to come from user fees, the fees paid by regulated industry under a variety of schemes including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and newly-created programs for generic drugs and biosimilars. As of today, FDA’s ability to collect and use these fees is in question, endangering vital agency activities including drug and device premarket review.

The threat to FDA user fees crystallized on September 14, when the Office of Management and Budget released its Report Pursuant to the Sequestration Transparency Act of 2012, explaining what may happen if Congress fails to reach an accord on the federal budget as required by the Budget Control Act of 2011 (BCA). Such a failure would trigger sequestration resulting in an 8.2% reduction in non-exempt, non-defense discretionary funding. On pages 79-80, the report indicates that $3.873 billion of FDA’s budget for 2013 is considered eligible for sequestration. According to analysis by the Alliance For a Stronger FDA, this indicates that major user fee programs have been included as sequestration-eligible funds. According to the OMB report, the FDA budget would be reduced under sequestration by around $318 million.

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Sunder on Patents and Access to Drugs

By Frank Pasquale

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  “I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

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