Petrie-Flom Center Executive Director Appointed to SACHRP

Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center at Harvard Law School, has been appointed by Secretary of Health and Human Services Sylvia Burwell to a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP).  SACHRP is a Federal Advisory Committee charged with providing expert advice and recommendations to the Secretary on issues and topics pertaining to the protection of human research subjects. To date, SACHRP has focused its attention on areas such as research involving children, prisoners, and individuals with impaired decision-making capacity; informed consent and the use of biospecimens; harmonization of human subjects regulations and guidance; the reduction of regulatory burden; the HIPAA Privacy Rule; community-engaged research, and accreditation.  Continue reading

Can Someone’s Sex be Situational?

by Vadim Shteyler

Dutee Chand’s career was rising quickly—in 2012 she was the Under-18 Indian National Champion for the 100-meter race. In 2013, she became National Champion in the 100 and 200-meter races as well as the first Indian to reach the final at the World Youth Championships. However, on July 15, 2014, her career was placed abruptly on hold when she was banned from all national and international competitions as a female competitor. Testing revealed that she had hyperandrogenism, that is her body naturally produced elevated levels of the male hormone, testosterone.

In April 2011, the International Olympic Committee (IOC) and the International Association of Athletics Federations (IAAF) had instituted policies banning all athletes with testosterone levels at or above the lower limit for males from competing in the female category. The policy allows women to requalify if they are shown to be resistant to the effects of testosterone or if they undergo one of a number of medical interventions to decrease their testosterone levels. This policy was a change from the extensive medical and psychological testing used for sex verification. (Read more about Caster Semenya, whose experiences catalyzed the policy change.)

Supporters of the new policy argued that a male competing among females has unfair advantage and, as such, furthers his career undeservingly and wins medals for his country unjustly. If increased testosterone levels largely contribute to the better athletic performance of males, then athletes with male-range testosterone should be banned from female competitions. Further, the IAAF cutoff for female testosterone levels is greater than 10 times the mean for average women, ensuring that the vast majority of women, even those with elevated testosterone, would not be disqualified based on these criteria. (Read more in The Journal of Sex Research.)  Continue reading

What’s to become of population health?

When the accountable care organization (ACO) model was initially conceptualized, many in the health policy world hoped it could provide a platform for real transformation of US health care.

Among the ACO model’s most promising innovations was its explicit orientation towards achieving “the Triple Aim.” First articulated by Don Berwick and the Institute for Healthcare Improvement (IHI), the Triple Aim is a strategy for optimizing the health care delivery system and achieving the best of all worlds. It outlines three goals: high quality health care, lower costs, and population health. The Center for Medicare and Medicaid Services adopted this goal and still describes a version of the Triple Aim on its webpage titled “Innovation.”

Continue reading

Post-Trial Access and Responsibilities (and Upcoming Conference, Sept. 18 at HLS)

By Zachary Shapiro

Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is widely available or approved for the market (or maybe longer/in other circumstances). At issue is the question of the commitment a clinical trial sponsor owes the participants of their trial (and maybe others) in the period after a clinical trial phase, but before market approval of the tested pharmaceutical (or maybe longer).

While the provision of Post-Trial Access may seem to be an ethical “no-brainer,” there are numerous variables that make the decision of whether to provide PTA difficult. One major question is whether all arms of the trial deserve access to the therapy, even those who were on placebo or in the control arm. If the therapy tested shows less efficacy than a more or less expensive treatment modality, is there a responsibility to provide the more effective treatment, regardless of the cost? What if said therapy is far beyond the standard of care for the condition in the particular country where the trial took place? Furthermore, how long do PTA obligations extend? While the simple answer is that they end after market approval, the truth is that many drugs have long approval processes, with complicating factors that can result in significant delays. This is an even more difficult question if the trial is a multi-regional study, and takes place in a country where the sponsor does not intend to market the product.

The question of how to provide PTA also poses logistical issues, as many sponsor sites close after a clinical trial is finished. This can make provision of post-trial access extremely expensive, and perhaps unduly burdensome, especially if the trial is sponsored by a biotech start-up without the deep pockets of a large pharmaceutical company. These costs can skyrocket depending on whether we believe the sponsor should be responsible for costs that might result from improper use of the therapy, or failure of the participants to comply with proper treatment. Continue reading

Harvard Effective Altruism: an event today, Michael Kremer on Sept. 10, and a fellowship opportunity

A message from Harvard Effective Altruism:

On Saturday, Sept. 6 at 3pm in Sever 111, we are holding a giving game / donation discussion and an information session for Harvard students interested in our organization. We’ll explain what effective altruism is and what HCEA does here on campus. If you’re new to HCEA, you should definitely check it out!

Wednesday, Sept. 10 at 4:30pm in Science Center Hall A: Prof. Michael Kremer – a development economist at Harvard – will give a talk entitled “How can individuals reduce global poverty?” He’ll discuss the ways that individuals can use both their money and their careers to contribute to poverty reduction and international development.

All semester long! HCEA is hosting its third Philanthropy Fellowship program for Harvard undergrads and graduate students. Fellows will attend talks from speakers like Harvard professor Steven Pinker, Rob Mather of the Against Malaria Foundation, and Center for Applied Rationality president Julia Galef; learn about effective altruism at weekly dinners with other fellows and speakers; get to know likeminded students at discussions and social events; and fundraise for effective charities! You can find more information and apply on our website before 11:59pm on Sunday, Sept. 14th.

We hope to see soon! Altruistically yours,
Ales and John

The FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

[Note: I am very pleased to have had the opportunity to write a response to a recent commentary posted on the Hastings Center Bioethics Forum about the FDA's proposed draft guidance for the regulation of laboratory-developed tests (LDTs), an issue I have previously written about for this blog. My response, which is posted here at the Bioethics Forum, is cross-posted below.]

Wendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care.

But the FDA’s proposal seems designed to address precisely these two consequences. The proposal could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA’s disclosure to Congress is critical to a full policy discussion of the situation.  Continue reading

9/18/14: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University.

Is “My Patient’s Agent” Always Justified?

Kelsey Berry

Is a physician always justified in acting as his or her patient’s agent?

This question is familiar to clinical and population-level bioethicists alike, though I hesitate to say that it is age-old. There are a variety of ways to approach a response to this question, as evidenced by extensive treatment of this topic in the philosophical and bioethics literature (which I will not survey here). One popular approach involves raising candidate circumstances that may justify deviations from the principal-agent relationship that obtains between physicians and patients* – for instance, ethicists might consider whether a physician is justified in deviating from acting as his or her patient’s agent under circumstances in which (a) the action that is in the best interest of the patient conflicts with the action that in the best interest of the population health, (b) the action that is in the best interests of the patient requires inefficient use of community resources on some criteria, or (c) what the patient perceives to be in his or her best interests conflicts with what the physician recommends, etc. This list is woefully inexhaustive, but it highlights a theme in this thread of argumentation. In each scenario, we’re invited to accept the initial assumption that the physician is justified, if not all of the time, at least most of the time, in acting as his or her patient’s agent. Then we are led to consider whether the candidate circumstances raised qualify as an exception to this rule.

The often-unarticulated premise, that the physician is typically justified in acting as his or her patient’s agent, is not without philosophical support from several prominent theories. We also have pragmatic reasons to begin with this premise, for there are few specific actors (to whom we can easily point) that compete with the patient for a principal-agent relationship of the type that obtains between a physician and his or her patient. Of course, other patients under care are obvious contenders, as are other potential patients. Though adjudicating between a physician’s obligations to both existing and potential patients raises interesting issues, the conflicts these principal-agent relationships give rise to still trade on the basic assumption that the physician has reason to maintain the basic fiduciary relationship in most circumstances. Continue reading

Harvard Effective Altruism: Nick Bostrom, September 4 at 8 PM

[This message is from the students at Harvard Effective Altruism.]

Welcome back to school, altruists! I’m happy to announce our first talk of the semester – from philosopher Nick Bostrom. See you there!

Harvard College Effective Altruism presents:
Superintelligence: Paths, Dangers, Strategies
with Nick Bostrom
Director of the Future of Humanity Institute at Oxford University

What happens when machines surpass humans in general intelligence? Will artificial agents save or destroy us? Professor Bostrom will explore these questions, laying the foundation for understanding the future of humanity and intelligent life. Q&A will follow the talk. Copies of Bostrom’s new book - Superintelligence: Paths, Dangers, Strategies - will be available for purchase. RSVP on Facebook.

Thursday, September 4
8 pm
Emerson 105

A Look at the ALS and Ebola Responses

By Deborah Cho

I’m a little late to this discussion, but I want to talk briefly about the ALS Ice Bucket Challenge and how we make our decisions on charitable giving.

I’m sure by now most readers understand the basic concept of the challenge: individuals can choose to either record a video of themselves pouring ice water over their heads or to donate money to the ALS Association (or both — the rules don’t seem to be particularly consistent in application).   After the challenge is undertaken, the video is shared on social media or a message is posted announcing that the individual has donated, and then the individual “nominates” others for the challenge.

This challenge has virtually taken over the web in the past couple weeks (perhaps, as one writer commented, because it lets participants “(a) exhibit his altruism publicly and (b) show off how good he looks soaking wet.”), raising over 88 million dollars as of August 26, 2014.  As expected, however, the challenge was not without its very vocal critics.  Many were opposed to the narcissistic nature of the challenge, while others, more relevantly, questioned donating so much money to a charity and to fight a disease based on an internet fad. Continue reading

Art Caplan: Is It Fair That Americans Received the Ebola Treatment?

Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains:

I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values we use when trying to ration access to an experimental drug. If we do not learn whether something is safe and effective, then we have missed an opportunity, even in the middle of an epidemic, to find out whether it is worth giving out drugs that are new, untested, and unapproved. People who should be included are those who can be observed and kept under surveillance — not for a day or a week but probably for months and years. That favors people who are not in rural villages. That favors people who will have access to hospital facilities. Those criteria will drive the selection of who receives a new, unapproved drug.

Click here to see the video and read more.

Ethics of experimental Ebola interventions

In “Ethical considerations of experimental interventions in the Ebola outbreak“, published yesterday by The Lancet, Zeke Emanuel and I discuss what we take to be the key ethical questions about the use of Zmapp and other investigational agents in the current Ebola epidemic. In essence, we argue that the national and international response to the epidemic should focus on containment and strengthening health systems, rather than experimental treatments and vaccines; that experimental interventions, if they are used, should be distributed fairly and only in the context of clinical trials; and that advance planning is needed for research in future Ebola and other epidemics, as well as for making any proven interventions against Ebola accessible in affected regions.

The full article is available open access. Be sure to check out the Lancet’s new Ebola Resource Centre as well, which includes many other interesting pieces and a podcast (access here podcast) covering—among other things—our paper.

Art Caplan: WHO Ethics Committee on Ebola Just a Start

Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola.

He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care Blog. As he writes in his piece in NBC News Health:

It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.

In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:

It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?

The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.

You can read more at the links above.

Art Caplan: Ebola Treatment Distribution is Troubling

Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplan critiques what he describes as the “bad science” behind choosing its recipients:

ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug made for many months. Deploying more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead, is the only way to get the epidemic under control. [...]

The fact that a 75-year-old has been given the scarce drug is especially disturbing, not because he is 75 but because 75-year-olds do not have strong immune systems — something very important in battling a virus like Ebola. Moreover 75-year-olds often have other medical problems that complicate the ability of scientists to figure out if the drug is safe and if it is really working.

In testing unapproved, highly risky drugs like ZMapp, it is crucial that recipients not be so sick that they may well die regardless of whether they get the drug or not. Indeed, the recipients ought not be very sick so that side-effects can be seen and efficacy determined. To do that, doctors need to be able to monitor experimental subjects for months to make sure the drug does not damage their livers or cause any other fatal side-effect. So not every person infected with Ebola makes for the best recipient — younger, those more recently infected and those who can be closely monitored are among the “best” candidates.

You can read more of Art Caplan’s perspective on NBC News Health here.