Conference on Digital Experimentation (CODE) at MIT Sloan

Screenshot 2014-09-30 18.19.55Another stop on my fall Facebook/OKCupid tour: on October 10, I’ll be participating on a panel (previewed in the NYT here) on “Experimentation and Ethical Practice,” along with Harvard Law’s Jonathan Zittrain, Google chief economist Hal Varian, my fellow PersonalGenomes.org board member and start-up investor Ester Dyson, and my friend and Maryland Law prof Leslie Meltzer Henry.

The panel will be moderated by Sinan Aral of the MIT Sloan School of Management, who is also one of the organizers of a two-day Conference on Digital Experimentation (CODE), of which the panel is a part. The conference, which brings together academic researchers and data scientists from Google, Microsoft, and, yes, Facebook, may be of interest to some of our social scientist readers. (I’m told registration space is very limited, so “act soon,” as they say.) From the conference website:

The ability to rapidly deploy micro-level randomized experiments at population scale is, in our view, one of the most significant innovations in modern social science. As more and more social interactions, behaviors, decisions, opinions and transactions are digitized and mediated by online platforms, we can quickly answer nuanced causal questions about the role of social behavior in population-level outcomes such as health, voting, political mobilization, consumer demand, information sharing, product rating and opinion aggregation. When appropriately theorized and rigorously applied, randomized experiments are the gold standard of causal inference and a cornerstone of effective policy. But the scale and complexity of these experiments also create scientific and statistical challenges for design and inference. The purpose of the Conference on Digital Experimentation at MIT (CODE) is to bring together leading researchers conducting and analyzing large scale randomized experiments in digitally mediated social and economic environments, in various scientific disciplines including economics, computer science and sociology, in order to lay the foundation for ongoing relationships and to build a lasting multidisciplinary research community.

Tomorrow: Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics

The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.

The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.

For the full job ad:
https://jobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?partnerID=25240&siteID=5341&AReq=33776BR

Live Blogging: Post-Trial Responsibilities Conference, Session 4

Panel Discussion: Christine Grady, Mitchell Warren, Richard Saver, Luann van Campen; Moderator: Mark Barnes

Session four of the Post-Trial Responsibilities conference featured a panel discussion of a complex hypothetical scenario. The hypothetical used in this session (available here) was made complex by design, to avoid the easy answers and to force readers to make difficult choices regarding both people and institutions.

In this hypothetical, the Ministry of Health in Angola begins a collaboration with a Belgian biotech company, BelgiqueTec. BelgiqueTec is not an established multinational pharmaceutical company, but is instead more like a start-up that’s been funded by some investment capital but which lacks deep pockets. BelgiqueTec has the rights to a diabetes drug and is interested in testing it in clinical trials. The Angolan government contributes $25 million to finance trials of the drug in Angola, due to the population’s burgeoning diabetes problem and concomitant development of wait times for treatment in the government’s diabetes clinics. In return, the Angolan government will take some ownership stake in the company and therefore in the outcome. There is an in-kind commitment of resources from Angola in terms of the study sites, which will be hospitals or clinics owned by the Angolan government or ministry of health (MOH). The agreement between BelgiqueTec and the government establishes that Phase I and II trials will be done in Angola, and any Phase III trials would feature a site in Angola (as well as elsewhere).

In the hypothetical, the Phase I trial was completed and showed no adverse effects. Now, a Phase II study has enrolled 200 treatment-naïve Angolan citizens with moderate to severe diabetes. Half showed improvement in the control of their diabetes, but three patients showed decreased cardiac function associated in time with drug administration, suggesting a potential causal link between administration of the drug and the observed cardiac side effect.

The first set of key questions for discussion was as follows: if drug development is halted at Phase II based on the adverse events, what are the obligations of BelgiqueTec and the MOH to continue to deliver diabetes treatments of any kind to the 200 Phase II subjects? Since a number of the patients showed improvement on the experimental drug, should the treatment be the experimental drug or the standard of care? For how long must the treatment continue? Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 3

By Robin Pierce

Session 3 of the Post Trial Responsibilities Conference, Lessons Learned, featured four speakers who have been involved in the conduct of trials for which post trial access was an issue. Moderated by Petrie-Flom Executive Director, Holly Fernandez Lynch, the session aimed to better understand real world experiences implementing post-trial responsibilities, including both successes and failures, and to more clearly articulate and assess the complexities involved. To do this, the speakers used case studies drawn from actual trials conducted around the world.

The first case study, presented by Joseph Millum of NIH, dealt with NIH-funded global HIV research, covered by the NIH policy on post-trial access to ARVs. Confronting the tough issues at the outset, Millum stated plainly that if there were no post trial access in the study at hand, which aimed to evaluate third line treatment options for HIV patients failing other regimens, there would be no way for affected participants to obtain the drugs that they needed to stay alive after the study. Here, Millum identified two key challenges – 1) access to drugs and 2) obtaining clinical care.

Millum devoted the rest of the discussion to describing the creation and implementation of a two part solution in which the manufacturers negotiated an agreement to provide darunavir, etravirine, and raltegravir free of charge for two years after study participation. Another element of the solution was created out of a recognition that in order for drugs to be administered at study sites, they had to be part of a study. Therefore, a final step was added to the study in which participants taking the drugs were given the option of staying in the study for an additional 96 weeks. For this, researchers tailored the consent process to state that after the study, the participant and his or her doctor will decide what treatment the participant should have and that study staff would discuss how the participants may be able to obtain the drugs post-trial. Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 2

By Zachary Shapiro

Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion.

We started with Richard Klein calling in from FDA:

Richard is talking about post-trial responsibilities. He points out that there is a justice issue here with ensuring access to health care and up to date interventions. He points out that while the FDA can encourage Post-Trial Access (PTA), it has no authority to require or ensure it. He points to moral authority, rather than legal. Foreign trials, however, are a different story, as the FDA has sway over protocol applications that are submitted in the US. Richard begins highlighting some specific considerations for protocol drafters and IRBs: particularly focusing on determining monitoring plans, as well as figuring out financial responsibilities for the provision of PTA.

He moves on to highlight that there is more of a moral obligation than a legal obligation. FDA is supportive of the provision of PTA. He believes that enthusiasm must be tempered, as there are situations when PTA is not appropriate. These include studies that have significant safety concerns, studies of bio-markers as well as validation studies that do not specifically examine safety and effectiveness. There are also situations where PTA is simply not feasible, particularly if additional drugs do not exist (one thinks of the recent Ebola treatment), if there is insufficient safety data, or if there is no practical capacity or resources to provide safety monitoring. We must also be aware of financial limitations, especially for start-up biotech firms that might not have deep pockets. Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 1

By Holly Fernandez Lynch

Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.”  We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon.

The conference was kicked off by Mark Barnes, co-director of MRCT, who pointed to two key statements of ethics that refer to post-trial responsibilities, the Declaration of Helsinki’s Paragraph 34 (DoH) – which Mark referred to as “mysterious,” as it could not in practice mean what it literally says – and the Council for International Organizations of Medical Sciences Guideline 10 (CIOMS).

Mark went on to describe the wide spectrum of issues that may be encapsulated in the simple phrase “post-trial access” – for example, over what period of time is access provided, is it provided for chronic diseases or only transient conditions, is it necessary only till a patient is stabilized or for longer, is it a lifetime commitment, does it apply only to research subjects themselves or broader research communities?  How much evidence should we demand of benefit before imposing post-trial responsibilities?  Exactly what should be provided – only the study drug, whatever was offered to the control group, other supportive care?  Must post-trial access be free of charge?  What about improved infrastructure, knowledge, and other benefits as components of post-trial access?  Our goal for the day will be to clarify the ways in which the Declaration of Helsinki, the CIOMS guidelines, and other ethical standards and regulatory requirements require additional guidance for practical application to the complex real-life circumstances of clinical trials.

The conference’s first panel – “Setting the Stage” – had the objective of introducing current ethical and regulatory approaches, as well as key controversies.  The panel was kicked off by Christine Grady (NIH), who gave a talk on the ethics of post-trial responsibilities, including history, models, agreements, and controversies.  Christine explained that compared to the very clear articulation of researchers’ responsibilities before and during a trial, they have very little guidance on what should happen when a trial is over.  Indeed, they had no guidance whatsoever until the 1990s, when there was both an upsurge in international collaborative research, and HIV research more specifically.  In that context, new efforts cropped up to minimize the possibility of exploitation in international research, including development of the concepts of responsiveness to local needs and reasonable availability of research benefits, as well as capacity building, collaboration, and community engagement. Continue reading

Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet ChatI’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.  Continue reading

Upcoming Event: Cutting-Edge Issues in the Ethics of Conducting Biomedical Research

DNAcode_slideCutting-Edge Issues in the Ethics of Conducting Biomedical Research

Thursday, October 9, 2014, 7:45 AM – 2:15 PM

Saul Farber Auditorium, Bellevue Hospital, 27th Street and First Ave (462 First Ave.), New York City

Registration is required for the conference.

Informed consent and Institutional Review Boards (IRBs) are the cornerstones of modern bioethical research but they do not solve all of the complicated issues of science, justice, and coercion that such studies raise.  The NYULMC Division of Medical Ethics invites you to a provocative program on cutting-edge issues in the ethics of conducting biomedical research.  Attendees will learn from leading experts and engage in discussions of current controversies, ranging from understanding ‘minimal risk’ in studies that involve socially vulnerable populations to the ethics of randomized controlled trials without consent.  Other topics to be covered include the contemporary implications of the U.S.-led sexually transmitted disease research conducted on Guatemalans during the 1940s; new strategies and technologies for improving informed consent; and the vexing issue of compassionate use.

For a list of speakers and conference agenda, click here [PDF].

NYULMC: Compassionate Use Could Impact Long-Term Medical Benefits

A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include:

  • Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the guidance of well thought out policies; some companies decline to allow access; some companies grant access but have no set guidelines; and some companies change their practices midstream as a result of public pressure. This lack of uniform policy is confusing to those seeking unapproved treatments.
  • Contrary to widespread perception, the U.S. Food and Drug Administration (FDA) is not an obstacle to those seeking compassionate use. In fact, the FDA almost always defers to the company that is developing the unapproved treatment to decide whether to grant compassionate use acces.
  • The “human impulse” to help patients facing insurmountable odds motivates both the general public’s support for compassionate use and so-called “right to try” laws to help gain access to unapproved treatments. However, increasing access to unapproved therapies may prove detrimental in the long run to longstanding and effective research and clinical trial systems through which interventions are proven effective and safe, and given regulatory approval.

You can learn more about the working group and read more of their findings here.

Tomorrow: 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. This event is also supported by the Oswald DeN. Cammann Fund.

Upcoming Event: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.

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

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

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.

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.

Ebola, Ethics, and the WHO Getting to Yes

Earlier this week, the World Health Organization, responding both to the international outcry over the rapidly rising number of Ebola cases and deaths across sub-Saharan Africa (and critiques of the speed of their action), and the news that western health care workers and ministry had found ways to get access to the untested-in-humans Ebola drug ZMapp, convened a panel of ethicists to offer recommendations on more widespread use of experimental Ebola treatments.

The issues considered by the ethicists included:

1) Whether it is ethical to use unregistered interventions with unknown adverse effects for possible treatment or prophylaxis. If it is, what criteria and conditions need to be satisfied before they can be used?

2) If it is ethical to use these unregistered interventions in the circumstances mentioned above, then what criteria should guide the choice of the intervention and who should receive priority for treatment or prevention?

Continue reading

Art Caplan: Why do two white Americans get the Ebola serum while hundreds of Africans die?

As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental serum. Caplan argues that the decision was a question of economics:

The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”

But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. [...]

But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. [...]

To get Caplan’s full perspective, read the full article.