Bad to the Bone

By Christopher Robertson

I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).  The article also suggests themes about medical malpractice, products liability, and physicians’ conflicts of interest too.

The Risk of Revictimization and the Ethics of Covering School Shootings: What Journalists Can Learn from IRBs

By Michelle Meyer

Updated below

Like most parents, after learning about the latest mass school shooting this morning, my thoughts immediately went to my own kindergartener. And of course, like most reading this blog, I thought about how poorly we handle guns and mental illness. Before too long, though, I couldn’t help but make a less direct connection between today’s events and my scholarly interests. I’m thinking of the way journalists cover school shootings as compared to how we regulate human subjects research.

As I write in The Heterogeneity Problem, 65 Admin. L. Rev. __ at 14-16 (forth. June 2013):

Studies on sexual abuse and assault, grief, war, terrorism, natural disasters and various other traumatic experiences are critical to better understanding and addressing these phenomena. But exposure to trauma — whether as a survivor or as a first rescuer or other third party — often causes substantial psychological morbidity. . . . Given their potentially fragile state, IRBs understandably worry that “questioning [or otherwise studying] individuals who have experienced distressing events or who have been victimized in any number of ways . . . . might rekindle disturbing memories, producing a form of re-victimization.”

IRBs — local licensing committees who operate according to federal statute and regulation and must approve most studies involving humans before researchers can even approach anyone about possibly participating — sometimes impose burdensome requirements on the way trauma research is conducted in order to protect adult subjects from the risk of revictimization. And they do so in addition to applying regulations that require that researchers disclose that risk (and others) to subjects.

Contrast this with the way journalists cover trauma. Read More

Film Review: How to Survive a Plague

By Suzanne M. Rivera

How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today.  Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG.  Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.

The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning.  As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS.  In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.

But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action.  It also is a provocative commentary about unintended consequences.  I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R).  In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Read More

Google, Whole Foods, and … Big Pharma?

By Nadia N. Sawicki

Google’s informal corporate slogan is “Don’t be evil.”  Whole Foods is a Fortune 500 company with a net revenue of 10 billion dollar that prides itself on a commitment to social responsibility.  Both companies have pledged to do long-term good in the world, even at the expense of short-term gains, and both are wildly successful.

If corporations can be profitable as a result of their commitments to social justice and corporate ethics, why can’t this doctrine be extended to the pharmaceutical industry?  Someday, a company called GoodPharma might reach the Fortune 500 on the basis of a pledge to improve access to medicine, conduct international research trials in accordance with the highest standards of research ethics, engage in research on orphan diseases, publish negative research findings, promptly report information about adverse effects, and generally act as a model for ethical industry practices.  If this business model hasn’t been explored, it should be.

Read More

What’s In a Name?

by Suzanne M. Rivera, Ph.D.

In regulatory and research ethics circles, it is fairly common to hear people say they prefer the term “research participant” to “research subject” because they feel it’s more respectful.  They think the word “subject” is demeaning.  I respectfully disagree.  I think it’s honest.

The federal agencies that oversee human research use both terms as though they are interchangeable.  The National Institutes of Health (NIH), for example, has a policy called, “Required Education in the Protection of Research Participants” which compels training for “individuals involved in the design and/or conduct NIH funded human subjects research.”

Of course, some research subjects are willing and active participants, but many are not.  The truth is that many people are studied without their consent or even knowledge.  In compliance with federal regulations, and under the watchful eye of ethics committees called Institutional Review Boards (IRBs), millions of medical records, biological specimens, and other sources of data (like court records, purchasing patterns, and web searching cookies) are mined by researchers every day.  You and I don’t participate in those studies.  They are done to us.  To the extent these studies are done with integrity, I don’t object.  But let’s not pretend we are participants. Read More

Twitter Round-Up (11/18-11/24)

By Casey Thomson

After what we hope was a hearty meal (or at least a restful, happy holiday) this past Thanksgiving for all of our readers, we are back with this week’s Twitter round-up – just a few days behind schedule.

  • Daniel Goldberg (@prof_goldberg) tweeted an article by Stefan Fatsis on the different perspectives regarding child participation in tackle football. As Goldberg noted in his tweet, from the perspective of neuroethics, the choice is clear: tackle football (or American football) is harmful for kids. (11/19)
  • Frank Pasquale (@FrankPasquale) included a link to a piece describing why data from all clinical trials should be readily accessible to doctors, or the origins of the BMJ Open Data Campaign. The article used the case of the Tamiflu anti-flu drug as an example, where the article authors described their hurdles in communicating with the drug’s producers concerning drug test results while trying to review the efficacy of the drug through Cochrane Collaboration. (11/21)
  • Kevin Outterson (@koutterson) posted his article, published in the New England Journal of Medicine, concerning the path for new federal regulations for compounding pharmacies in the wake of the meningitis outbreak and the New England Compounding Center (NECC). (11/23)
  • Arthur Caplan (@ArthurCaplan) brought up a recent post concerning the American College of Obstetricians and Gynecologists (ACOG) and their declaration that making birth control pills over-the-counter (OTC), rather than prescription, could reduce the rate of unplanned pregnancies in the United States (which has not changed in 20 years). While the change would not occur overnight, there are many consequences that remain unclear – including changes in price and insurance coverage. (11/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link to David Shaywitz’s article, which noted the increased criticism and distrust facing industry studies as compared to those of university scientists. Shaywitz encouraged contextualization of industry criticism to recognize that such critiques often plague medical science in general, not just industry. (11/24)

Note: As a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.

Variability in Local IRB Regulation: A Gold Mine for Future Research

By Christopher Robertson

When I moved to the University of Arizona, I quickly discovered something that I’ll politely call “heterogeneity” in Institutional Review Board’s (IRB) policies and practices.  All of a sudden, some of the rather vanilla human subjects research practices I had been doing for years, with IRB approval, were now forbidden.  Turns out that I had been exerting “undue influence” on human subjects all along by — wait for it — telling them how much I proposed to pay them.  (Good thing there is no IRB jail for miscreants like me.)

I’ve since learned that there is a scholarly literature about the tendencies of IRBs to vary in how they decide the same cases.  For example, Green and colleagues (2006) described their experience getting IRB approval for an observational study in 43 Department of Veterans Affairs medical centers.  They explain:

The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA … consent from physicians although no health information was asked of them. … Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.  Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions.

How can such disparate results come out of IRBs all applying the same Federal common rule?  And is that sort of variability justified by the 4,680 hours of staff time that Green reports spending navigating through this regulatory maze?  As I explain below the fold, this incident is not isolated.

Read More

Are Human Research Participants Deserving of Research Animals’ Rights?

by Suzanne M. Rivera, Ph.D.

For years, mainstream and extremist organizations have waged campaigns against the use of animals.  While PETA successfully deploys propaganda featuring provocative models in sexually explicit positions to denounce the use of animals for food, clothing and experimentation, other groups, such as the Animal Liberation Brigade, engage in violent (some would say terroristic) actions to disrupt animal research and scare off scientists from lines of inquiry for which the use of animal models is the state of the art.

Part of the philosophy of the anti-animal research groups is a belief in moral equivalency among species.    PETA’s Ingrid Newkirk once famously said, “A rat is a pig is a dog is a boy.”  Does she propose we allow people to suffer with treatable diseases because non-animal models for testing have not yet been developed?  Apparently so.  Newkirk also has gone on the record to say, “Even if animal tests produced a cure for AIDS, we’d be against it.”  This view is out of step with the majority of Americans, who – according to the latest Gallup poll— support animal research.

Among those who regulate and support animal research, there is a very strong commitment to animal welfare.  The “animal welfare” perspective contrasts with the “animal rights” view.  The animal rightists want to end animal use, including research (and also eating meat, hunting, zoos, police dogs and entertainment), because they see it as inherently indefensible.  Animal welfarists, on the other hand, believe animals can be used humanely, under strict rules that seek to prevent unnecessary pain and distress in research animals.  They acknowledging that the animals’ lives are worthy of respect, but do not ascribe the moral status of personhood to them.  The US government requires scientists to assume anything that could cause pain or distress in a human also would be painful for an animal, and they are compelled to provide analgesia and anesthesia accordingly.

Read More

Study Guide on the Guatemala STD Inoculation Studies

Talk about perfect timing.  Just on the heels of Tuesday’s fantastic event at HLS on the Guatemala STD Inoculation studies (video to come soon), the Presidential Commission for the Study of Bioethical Issues has released A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.  This is the Commission’s first foray into pedagogy, and an absolutely fantastic way to keep the discussion going.  Be sure to check it out, and to share widely.

Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

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