The Constitutional Implications of Ebola: Civil Liberties and Civil Rights In Times of Health Crises

Join us for an important public forum:

Constitutional Implications of Ebola:
Civil Liberties & Civil Rights In Times of Health Crises

This public forum addresses the constitutional and public health implications of Ebola response in the United States.  According to state and federal laws, patient information is deemed private and is to be held in strict confidentiality.  However, in the wake of Ebola, well-established protocols to guard patient privacy have been neglected or suspended without public debate.  At this forum, a panel of experts raise questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy, civil liberties, and civil rights.  To what extent are Americans’ Ebola fears influenced by the origins of the disease?  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?

Speakers: Reverend Jesse L. Jackson, Sr.;  Michele Goodwin, Chancellor’s Chair, UC Irvine School of Law;  Professor Andrew Noymer, UC Irvine School of Public Health; and Dr. George Woods, American Psychiatric Association.

This Forum intervenes in the current national and international discourse on Ebola by probing law’s role in addressing public health crises.  This forum is free and open to the public.

WHEN: Wednesday, November 19, 2014, 3.30pm-5.30pm

WHERE: University of California Irvine, School of Law; ROOM EDU 1111, 401 E Peltason Dr, Irvine, CA 92612

A Lack of Pep for PrEP

By Emily Largent

The Kaiser Family Foundation (KFF) recently conducted a survey of gay and bisexual men in the U.S. focusing on attitudes, knowledge, and experiences with HIV/AIDS.  The survey results, released Thursday, can be found here.  I was most interested in the finding that only a quarter of those surveyed know about PrEP (pre-exposure prophylaxis).

PrEP (brand name Truvada) is a combination of two medicines (tenofovir and emtricitabine) that has, if taken consistently, been shown to reduce the risk of HIV infection in people who are high risk by up to 92%.  The FDA approved an indication for the use of Truvada “in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” in 2012.  The U.S. Public Health Service released the first comprehensive clinical practice guidelines in May of this year. Continue reading

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 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

The Expressive Dimension of Donor Deferral

By Dov Fox

The Guardian and L.A. Times are the latest major news organizations to decry trans-Atlantic restrictions on blood donation by men who have sex with men (MSM). The case against such categorical bans has been reignited by an influential piece that Bill of Health editor Glenn Cohen recently published with co-authors Jeremy Feigenbaum and Eli Adashi in the Journal of the American Medical Association. Cohen, Feigenbaum, and Adashi make a powerful case why sexual orientation should be just one component among others used to assess the risk that blood donors might spread HIV.[i]

But their argument elides exactly what is—and isn’t—wrong with excluding men who have sex with men from donating blood. At times they suggest the longstanding U.S. ban reflects “outdated homophobic perceptions.” Yet they acknowledge that it was “well-intentioned and guided by a need to protect the integrity of the national blood supply.” Indeed, the Food and Drug Administration that enacted the lifetime MSM ban solicited guidance from the National Gay Task Force whose recommendations were adopted into Red Cross blood collection procedures.[ii] It’s unlikely the policy was motivated by animus as opposed to concern for public health.

Elsewhere, the authors imply the policy’s chief offense is that it deprives MSM of a crucial “civic opportunity.” But giving blood, even if it shares the life-saving potential of military service and registration as an organ donor, is not typically regarded as a duty of citizenship tantamount to voting or jury service.[iii] So it’s not its effects on those it excludes that makes the donor ban so bad.

The best reason to let low-risk gay men give blood lies in the demeaning message that excluding them expresses, what I’ve called the expressive dimension of donor deferralContinue reading

Good news for many South African HIV patients—with a big glitch

On Wednesday, South African Health Minister Aaron Motsoaledi announced that, as of January 2015, HIV-positive patients in the country would start receiving free antiretroviral treatment once their CD4 count fell below 500, instead of current threshold of less than 350. Some patient groups would start receiving antiretrovirals immediately upon being diagnosed with HIV infection, regardless of their clinical stage.

Last month, Till Bärnighausen, Dan Wikler and I predicted in PLoS Medicine that sub-Saharan nations would move in the direction that South Africa is now moving, and pointed out a big complication. This policy change might make several gigantic trials of so-called treatment-as-prevention in sub-Saharan Africa impossible to complete successfully. As we explained, these trials remain important for assessing the potential of treatment-as-prevention to curb the spread of HIV in general populations (with many different relationship types and different levels of care delivery and support).

In treatment-as-prevention, antiretrovirals are offered to patients immediately upon their diagnosis with HIV. The hope is that very early treatment would be better for these patients and prevent them from infecting others. We also offered some ways out of this mess, but they involve untraditional approaches to research conduct and to policy. Our piece was featured in the June issue of UNAIDS’ HIV This Month.

When you Can Shed Blood for your Country but not Donate it

Portsmouth, Va. (Jan. 5, 2005) - A hospital corpsman assigned to USS Bataan (LHD 5), donates a pint of blood during the blood drive held by the Blood Donor Team. The Blood Donor Team stationed at Portsmouth Naval Hospital visits multiple commands throughout the area in efforts to boost the blood supply for the U.S. Armed Forces around the world. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

A hospital corpsman donates a pint of blood. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

I have a new article in JAMA this week, “Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men,” co-authored with my former student Jeremy Feigenbaum and my frequent co-author Dr. Eli Adashi (former Dean of Medicine at Brown). In the article we show that FDA’s current policy is morally, ethically, and legally problematic. We are out of step with our peer countries (including the UK, Canada, South Africa) who do delay when men who have sex with men can give blood but not for a lifetime, the way the U.S. does. It is remarkable that if you have sex with a female prostitute or a woman who is HIV+ you face only a 12-month deferral in the U.S. but if you have had sex with a man, just once, ever, no matter his HIV status you face a lifetime delay.

We are in a world where the Defense of Marriage Act was struck down as unconstitutional, where Don’t Ask Don’t Tell has been struck down so that gay men and lesbians can proudly serve their country and shed blood (their own, others) on the battlefield. It is time to change a 30-yr old policy prohibiting them giving blood. What’s more, given the the Windsor decision and the recent Ninth Circuit application of heightened scrutiny to the exclusion of gay jurors for jury duty, we think there are serious constitutional questions about FDA’s policy as well.

My preferred approach, and the one I think FDA should move towards, is the Italian “test and assess” which has no blanket classification of MSM but instead does individualized risk assessment. As we describe in our paper thus far has not increased the risk of HIV+ blood making its way into the blood supply.

The Williams Institute in 2010 estimated that 6% of men had at least once had sex with another man, meaning there are potentially 7.2 million men who could become blood donors but are excluded by FDA’s rule. We owe it not only to these men, but also to all those who could benefit from their blood donations to revisit this rule.

National Conference on HIV Criminalization

By Sterling Johnson, JD

Grinnell College in Iowa will host the first National Conference on HIV Criminalization next week, June 2-5 on its campus.

One of the stated goals of the conference will be to discuss the recent legislative changes in Iowa and how to apply the lessons to other states with laws that apply specifically to people with HIV.

Currently, 43 states criminalize actions by HIV-positive individuals. Check out our map at LawAtlas.org for more details.

US states with HIV criminalization laws

In 2009, Iowa became the center of this battle when Nick Rhoades, who is HIV-positive, had a one-time sexual encounter with another man, Adam Plendl. Three months after, Mr. Rhoades was arrested on suspicion of engaging in intimate contact without disclosing his HIV-positive status. At the time of the sexual encounter, he used a condom, had an undetectable viral load and his sexual partner did not contract HIV; however, Nick Rhoades was sentenced to 25 years in prison and classified as a sex offender. The case is now is now on appeal and being argued by Lambda Legal. The Iowa court of Appeals affirmed the conviction and the case is now under review by the Iowa Supreme Court. Mr. Rhoades’s case led to community organizers lobbying to reform the HIV criminalization law in Iowa. Continue reading

Art Caplan: Condoms Should Be Encouraged, Not Used as Evidence

Art Caplan has a new opinion piece up at NBC News on the increasing use of condoms as evidence of a crime by police in the United States. From the article:

Why do we shoot ourselves in the foot when it comes to public health? The latest example of what not to do in the war against disease comes from the world of sex: All over the United States, police and prosecutors are discouraging safer sex by using the possession of condoms as evidence of a crime.

For decades, police officers have been regularly confiscating condoms from people they believe are engaged in prostitution to either justify an arrest or to use as evidence at trial. District Attorneys routinely mention the number of condoms a person had on them when arrested to help cinch prostitution charges.

Prostitutes are far more likely to be infected with HIV and other sexually transmitted diseases than are the general population. That is why health departments spend a lot of money distributing condoms and trying to convince sex workers to use them.

Read the full article.

FOR HARVARD STUDENTS: TOMORROW: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

TOMORROW: panel discussion, Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy. 

3/27: panel discussion on Current Legal Issues in HIV/AIDS Work

Current Legal Issues in HIV/AIDS Work

Thursday, March 27, 2014, 12:00pm

Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:

  • Felix Lopez, Director of the Legal Department, GMHC
  • Jason Cianciotto, Director of the Public Policy Department, GMHC
  • I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  • Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy. 

Trials of HIV Treatment-as-Prevention: Ethics and Science. Friday, March 7

High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.

  • Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
  • Max Essex, Harvard School of Public Health
  • Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
  • Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
  • Dan Wikler, Harvard School of Public Health
  • Nir Eyal, Harvard Medical School

 

Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School

 

Friday, March 7th, 10am-12pm

Kresge G3, Harvard School of Public Health

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

Ryan White, Third-Party Payments, and Discrimination

By Jeremy Kreisberg

In November of 2013, CMS became concerned that hospitals and other providers might help their patients purchase insurance by contributing to their premium payments or cost-sharing obligations.  The motivation for providers was clear: if the amount they could expect to receive from an uninsured patient (likely very little, if anything) was less than the difference between the reimbursements from an insurer and the contribution the provider made to the patient’s insurance payments, it would be profitable for providers to contribute.  CMS’s concern was also clear: if hospitals began paying for their patients’ insurance, they would likely be cherry-picking the sickest patients with the highest expected reimbursements, which would skew the risk pool for all consumers.  So CMS issued a guidance discouraging insurers from accepting those third-party payments from providers.

What CMS did not say was that insurers should stop accepting all third-party payments.  This was a point that CMS has had to clarify in light of the decision by several insurers in Louisiana–including BlueCross BlueShield of Louisiana (BCBS-LA), the largest insurer in the state–to refuse third-party payments from anyone (aside from immediate family members/blood relatives or legal guardians).  Importantly, this includes the government, which provides grants through the Ryan White Program to low-income citizens with HIV/AIDS.  The motivation for insurers is clear: they don’t want to have to continue paying for expensive medical care required by people with HIV/AIDS.  But this desire runs directly contrary to the government’s intention to help provide insurance coverage through Ryan White grants to people with HIV/AIDS who could not otherwise afford it.

After the jump, I’ll discuss the Louisiana insurers’ response to CMS’s clarification:

Continue reading

Art Caplan on Mandela’s AIDS legacy of silence and courage

Art Caplan has a new piece over at NBC News online on Nelson Mandela’s AIDS legacy:

[...] It had been an enormous mistake to ignore the epidemic, made even worse by installing an AIDS denialist as his favored successor.

In 2003 Mandela began to speak out plainly and forcefully about AIDS. And he acted. He created a foundation to fight HIV/AIDS, the Nelson Mandela Foundation, and began a fundraising campaign to support HIV prevention and public health efforts called 46664, his identification number when he was imprisoned by the apartheid government on Robben Island. For the rest of his life he urged people to talk about HIV/AIDS “to make it appear like a normal illness.” And he used his reputation to make HIV prevention and AIDS treatment an international issue. In his retirement, he put AIDS at the top of his personal agenda.

[...]

Mandela vigorously took on critics, speaking courageously about AIDS and the importance of using the best science and public health knowledge to defeat it. Our greatest ethical leaders like Mandela are never more instructive than when we learn not just from their triumphs, but also from how they recognize and respond to a mistake.

Read the full article.