Better Late than Never! Petrie-Flom Interns’ Weekly Round-Up: 4/06-4/19

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

When Ethics Collide

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[Posted on behalf of Nancy Dubler and Art Caplan]

Surprising that for a week there was constant news from Boston.  Minute by minute we heard details of carnage, searching, killing, lock down and capture.  Now, pretty much, silence.

The suspect, captured in a boat in a backyard in Watertown, is now both a prisoner and a patient.  That has proved, historically and most recently, to be a difficult dual status for physicians to address.  It is hard for those who want to interrogate him.  And hard for those who wish to initiate his arraignment and prosecution.  But they along with the rest of us must wait.

Prison and jail health care present an anomaly for medical caregivers.  The goals of medicine are to diagnose, cure and comfort.  The goals of the justice and correctional systems are to confine, try, sentence and punish.  These are not only mutually exclusive goals but, they make strange and strained bedfellows when the two must work together.

We know one can coopt the other.  American doctors who agreed that torture could continue, without killing the prisoner, during recent years when water-boarding was a clear part of the anti-terror arsenal, violated their oaths as physicians to attend only to the medical, physical and emotional needs of the patient…to do no harm.

In the same vein, on July 17, 2008, the AMA articulated its policy about executions clearly and unambiguously — “requiring physicians to participate in executions violates their oath to protect lives and erodes public confidence in the medical profession. A physician is a member of a profession dedicated to preserving life when there is hope of doing so. The use of a physician’s clinical skill and judgment for purposes other than promoting an individual’s health and welfare undermines a basic ethical foundation of medicine — first, do no harm”.  Yet physicians do participate in executions often using their respect for the criminal justice system as their rationale.

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Will Your Law Firm (or Other Employer) Pay for Your Egg Freezing? Should It? (Online Abortion and Reproductive Technology Symposium)

I. Glenn Cohen Leave a comment

As John Robertson mentioned in his post earlier this week, in order to avoid age-related infertility many women are considering or will soon consider using egg freezing, as the technology has dramatically improved. As compared to freezing preembryos, for example, this is an attractive option since many of these women (heterosexual or otherwise) may not yet have chosen a reproductive partner, and also may want to hedge their bets to have options should they divorce. Still, the technology is not cheap.

At least one participant at the the bricks-in-mortar symposium reported to me that they knew of one Am Law 100 firm that will cover egg freezing for its lawyers. I would be grateful if folks in the comments section could indicate whether they knew whether their firm covers it as well. [Ed. Note: If you have any trouble with the comment function on the blog, which is still giving us trouble, send a note and we’ll get it posted for you through the admin account.] My own impression is that this is not yet widespread, but that might change as the practice becomes more common and thus the market converges (perhaps with a push from Above the Law).

Should law firms cover egg freezingt? I have made the argument elsewhere for coverage of reproductive technologies by insurance more generally from a moral and economic perspective. In the case of law firms, I am curious about the PR implications for the firm. Would potential female associates welcome this option knowing that they can work hard early on and still reproduce, if they so desire, later on? Or would they take this as a signal that the firm thinks that working there as an associate and pregnancy are incompatible? Would this option help remedy the deficits faced by women who want to have children on the partnership track or would it in fact exacerbate discrimination against women who do choose to have families early on while at the firm, with the thinking being “she could have waited.” More generally, would this be a blow for or against gender equity at law firms?

Beyond the Patents-Prizes Debate

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By Ryan Abbott

In Beyond the Patents-Prizes Debate (forthcoming in the Texas Law Review), Daniel Hemel and Lisa Larrimore Ouellette articulate a new theoretical framework for thinking about R&D funding mechanisms. They note that patents, prizes, government grants, and tax credits for research all play an important role in facilitating innovation, although academic literature has disproportionately focused on the role of patents and prizes—this is the first detailed analysis of how tax credits compare as an incentive mechanism.

The Orphan Drug Act (ODA) illustrates how patents, grants, and tax credits can all be used to achieve similar goals. The ODA was passed in 1982 to incentivize R&D on rare diseases. It incorporates several different types of incentives, including direct government grants for research, a patent-like market exclusivity period for approved drugs, and tax credits for half of the cost of clinical research. The ODA has been widely acknowledged as successful. From 1973–1983, U.S. pharmaceutical companies only brought 10 orphan drugs to market. In the twenty-five years since the Act’s passage, 326 new drugs were approved for rare diseases. The ODA was also the model I proposed in an article last year for a new system to boost R&D for evidence-based complementary and alternative medicine (CAM).

Given that all these mechanisms can accomplish the same goal, possibly even with the same costs, and no single mechanism is always more efficient than the others, a framework is needed for determining which incentive is most appropriate for a given goal. The authors do this by providing a structure for balancing the benefits and detriments of each incentive on the basis of who should determine the reward size, when the reward should be provided, and who should pay.

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Reminder – Petrie-Flom Student Fellowship Applications Due May 20

The Petrie-Flom Center Staff Leave a comment

[Note: This Student Fellowship program is different from the Petrie-Flom Center Academic Fellowship, applications for which will open again in the Fall.]

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  For more information on our current fellows and their work, see our website. 

Eligibility. The student fellowship program is open to Harvard Law School students and students in other Harvard graduate programs who are committed to undertaking a significant research project during the year of their fellowship. 

Keep reading for additional information on fellowship requirements and applications…

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Upcoming Talk: Pharmaceutical Efficacy, The Illusory Legal Standard

The Petrie-Flom Center Staff Leave a comment

Jonathan Darrow, PFC Student Fellow and HLS SJD student, will be presenting his chapter – “Pharmaceutical Efficacy: The Illusory Legal Standard” – on Tuesday, April 23, at noon in Hauser 105, Harvard Law School, Cambridge.

If you’d like to review the chapter in advance, please be in touch with Jonathan directly: jon underscore darrow at yahoo dot com.

Further On the Fake Anti-Government Electorate

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

In recent posts, I have been pointing to research that suggests that government intervention for public health is actually rather popular as a general matter. Now comes a neat paper that takes on the question of whether politicians actually know what their constituents want.  I read it as further evidence that our politics is being shaped by a lot of well-supported anti-government noise-making that has been allowed to flourish unchallenged.

The paper in brief: the authors surveyed candidates for state-level legislative office, and used a technique called multi-level regression and post-stratification (MRP) to localize opinion poll data to legislative districts. They then compared what candidates think their constituencies believe on key issues (health care reform, gay marriage, welfare reform) with what the polls say their constituents believe.  They find that both conservatives and liberals significantly overestimate the conservatism of the people who elect them:

“In districts where supporters of these policies outnumber opponents by 2 to 1, liberal politicians appear to typically believe these policies enjoy only bare majority support while conservative politicians typically outright reject the notion that these policies command widespread support.”

The paper is worth reading for its findings (and to allow you to personally assess its limitations – this has not yet even been peer reviewed.) A more detailed summary with some of the charts is on Dylan Matthew’s Washington Post blog.

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New Support for the SUPPORT Study in NEJM

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The New England Journal of Medicine has two new commentaries out on the SUPPORT study and arguing that OHRP has things all wrong – in a dangerous way.

From the editors:

“[OHRP’s] response is disappointing, because it does not take into account either the extent of clinical equipoise at the time the study was initiated and conducted or that the consent form, when viewed in its entirety, addressed the prevalent knowledge fairly and reasonably. At the time, as explained in the principal investigator’s response to the allegations and in a related letter to the editor in the Journal, there was no evidence to suggest an increased risk of death with oxygen levels in the lower end of a range viewed by experts as acceptable, and thus there was not a failure on the part of investigators to obtain appropriately informed consent from parents of participating infants. Through hindsight (and essentially faulting investigators for not informing parents up front of a risk later uncovered by the trial itself), the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice. . . . The OHRP has a duty to investigate questions of research impropriety, but we strongly disagree with their determination of inadequate informed consent in this case.”

And from Art Caplan and David Magnus:

“With regard to SUPPORT, the OHRP is asking that research be described as riskier than it really is and is suggesting that the parents were duped into enrolling their frail infants in dangerous research. Not only is that not true, but it also poses substantial risk to the conduct of valuable comparative effectiveness research both for premature infants and for the general public who continue to face too many treatments where uncertainty prevails about what is best.”

There is also a letter to the editor from the SUPPORT study group themselves.

What do you think – is this OHRP’s latest version of its checklist debacle, or are they right here?

Revisions to the Declaration of Helsinki

Holly Fernandez Lynch Leave a comment

On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki.  The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.”

You can see a side by side analysis of the proposed revisions and explanatory comments here.  We’ll see what happens down the road, but a few things are worth noting:

  1. The working group responsible for the revisions explicitly acknowledges that it cannot literally be true that the well-being of the individual research subjects must take precedence over all other interests (new paragraph 8/old para. 6).  Nonetheless, it retains that language for aspirational purposes – a strange choice, IMHO, which could conceivably lead to less respect for the Declaration as a whole.
  2. The revised Declaration would (in line with almost every other ethical body to consider the issue) add a new paragraph indicating that “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured” (new para. 15).  The current version (old para. 14) states only that the protocol should include “provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.”  The nature of the Declaration is such that it doesn’t provide much detail, but even this revised statement is a step in the right direction.  Will US regulators ever take the hint?
  3. The revisions would take a harder stance toward research involving disadvantaged or vulnerable populations, permitting research with these groups only when it could not be carried out in a non-vulnerable population (new para. 20/old para. 17).  I understand the sentiment…really I do.  But this approach seems to unduly discount the real benefits that accrue to research participants and communities just by virtue of having the research done there.  And if research is responsive to population/community needs and priorities AND the population/community stands to benefit from the research – two standards that remain in the revised Declaration – why do we need the third criterion that research couldn’t be conducted in an alternative population? Read More