Category: HIV/AIDS

Upcoming Event – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

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Monday, November 5, 2012
12-1:30 pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Early Warning on Heroin and Syringe Exchange?

Temple University Center for Public Health Law Research 2 Comments

By Scott Burris

It’s hard to believe that after all these years, all the evidence, and all the reductions in HIV among injection drug users, we still only have 15 states that explicitly authorize syringe exchange programs (SEPs). (See LawAtlas for an interactive map.)  CDC estimates we still have around 4,000 new cases a year by injection, so that’s reason enough to keep the SEPs we have open and start new ones where drug users are not now being reached.

Now another factor could be in play. Harm reductionists are reporting an upsurge in SEP users in places where efforts to crack down on illicit pill use have started to bite.  A lot of these users are reportedly young, under 25, and at serious risk of getting HIV or HCV.

So far we only have anecdotal reports. It could be coincidence, or overblown.  But we should be worried: there is nothing strange about pharmaceutical opioid users moving on to heroin when pills get scarce. It would be prudent as a matter of health policy to make sure that syringe access services are available in every community where opioid users are injecting, and to make sure these programs have surge capacity.  That’s prudent policy: here on planet earth we are cutting health budgets and, I fear, ignoring the effect of pill control on heroin use.

All this reminds us how important it is to be closely evaluating the consequences of new laws and policies that are intended to reduce illicit pill use.  Their success in reducing consumption is only part of the picture: the ultimate issue of concern is that we protect the health of people who are using until they can reach a safer place in their lives.

Home HIV Testing, partner screening, the medicalization of intimacy, and responsibility for health

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As the New York Times reported this week, in an article entitled “Another Use for Rapid Home H.I.V. Test: Screening Sexual Partners,” some in the public health community are exploring the ramifications for a use of the new OraQuick home HIV test that the company has been somewhat coy about: using it to test a new partner before sex, which may be particularly likely in the gay community. On November 5, 2012, the Petrie-Flom Center (in collaboration with Fenway Institute and Center for Health Law and Policy Innovation) will be hosting a great live panel (open to the public) “Advances in HIV Prevention: Legal, Clinical, and Public Health Issues,” focused in part on the OraQuick test and also on Pre-Exposure Prophylaxis (Truvada). The event will also be webcast after the fact.

Unfortunately, I’ll be in Malaysia touring hospitals as part of the research on my new book on medical tourism during the event, but I thought I’d use this forum to share some of my thoughts/questions about the use of these tests for partner screening. Here they are in a few different boxes:

The Medicalization of Intimacy: Is there something problematic about intimate sexual conduct becoming a medicalized affair to some extent? We are not all the way to the scene in Gattaca where Uma Thurman plucks a hair from Ethan Hawke to genetically profile him before deciding whether to pursue him romantically, but this use of OraQuick does interpose a medical technology into a sexual relationship. Now there may (more on that below) be public health benefits such that the development is all-things-considered for the best, but is something lost when this happens? Perhaps a separate spheres concern when technology is used to replace trust/intimacy? Or is this overblown? How will this affect the personal lives of individuals with HIV, and is that relevant?

Overreliance and the Effect on other STIs: The Times Article suggests that the designers of the test have made a specific choice as to Type 1 v. Type 2 errors: “It is nearly 100 percent accurate when it indicates that someone is not infected and, in fact, is not. But it is only about 93 percent accurate when it says that someone is not infected and the person actually does have the virus, though the body is not yet producing the antibodies that the test detects.” Will individuals who do partner screening internalize these numbers or will they go right from a negative test to no condom use, not processing the 7% risk the test is incorrect? Moreover, even if correct, will the test lead to (a) internalization of poor sexual health practices (no condoms) that users will carry over to encounters where they do not use the test, and/or (b) the spreading of non-HIV STIs like gonorrhea (the New Yorker recently gave a terrifying account of the rise of antibiotic-resistant gonorrhea)? What is the tort liability for the company in one of these situations, if any? If we think some individuals will be bad decision-makers and put themselves at greater risk for non-HIV STIs (not saying the data is there, just asking “what if” or the sake of argument) should that be relevant as to whether such tests should be available/approved? Do the numbers matter? Or is it the case that if even one person might avoid an HIV infection that would outweigh, from a policy perspective, an increase in other STIs of a large size? Those who have followed my writing and blogging on health care rationing can probably guess where I stand on the issue…

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Cited by the Supreme Court: Oh, the Indignity and Humiliation of It!

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By Scott Burris

A law professor is usually thrilled to have an article cited by the Supreme Court.  An empirical researcher will, likewise, be pleased that evidence he or she helped create shapes a decision of the highest court of the land.  But maybe not always.

Today I learned that the Supreme Court cited a study of mine in a major opinion. OK, it was the Supreme Court of Canada, but still.  The case, which deals with the criminalization of HIV, is pretty interesting and important.  The unimportant part has to do with the impact of my work on the decision:

 Some interveners challenge the use of the criminal law in the case of HIV on the ground that it may deter people from seeking treatment or disclosing their condition, thereby increasing the health risk to the carrier and those he has sex with.  On the record before us, I cannot accept this argument.  The only “evidence” was studies presented by interveners suggesting that criminalization “probably” acts as a deterrent to HIV testing: see e.g. M.A. Wainberg, “Criminalizing HIV transmission may be a mistake” (2009), 180 C.M.A.J. 688.  Other studies suggest little difference in reporting rates in states that criminalized and did not criminalize behaviour:  S. Burris, et al., “Do Criminal Laws Influence HIV Risk Behavior?  An Empirical Trial” (2007), 39 Ariz. St. L.J. 467, at p. 501.  The conclusions in these studies are tentative, and the studies were not placed in evidence and not tested by cross-examination.  They fail to provide an adequate basis to justify judicial reversal of the accepted place of the criminal law in this domain.

The Court is right, but maybe it could have gone without saying — or citing?

“Overcriminalization” and HIV

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By Scott Burris

The concept of “overcriminalization” is gaining traction across the political spectrum.

The Heritage Foundation, which has a website devoted to the phenomenon, defines it as “the trend in America – and particularly in Congress – to use the criminal law to ‘solve’ every problem, punish every mistake (instead of making proper use of civil penalties), and coerce Americans into conforming their behavior to satisfy social engineering objectives.”   Others, like Michelle Alexander, drop the Ayn Rand tones and focus on mass incarceration as racialized social control. (My colleagues and I once calculated that African American males can expect to spend on average 3.09 years in prison or jail over their lifetime.) Douglas Husak argues that we need a theory of criminalization to help us get less of it.

One of the best examples of criminal law rushing in where angels fear to tread is the criminalization of HIV exposure. From the start, there was reason to fear that these laws would not reduce HIV transmission, and might exacerbate stigma and social hostility towards people with HIV. There was concern they might be used selectively, or just randomly.

This summer, the UN’s Global Commission on HIV and the Law advised states to repeal or abstain from enacting such laws.  The Commission drew on a set of background papers that reviewed the extent of the phenomenon globally and addressed the argument that these laws are justified by moral values even if they are ineffective.

In this country, the President’s National AIDS Strategy suggested states reconsider these laws, but no laws have been repealed and prosecutions continue.  Fortunately, so does research, and it continues to show that these laws are not promoting public health. This week, the American Journal of Public Health published a new PHLR-funded study by Carol Galletley. This video sums up her findings:

Intellectual Property in Investment Agreements: More “Teeth” for Foreign Investors’ IP Rights, Less for Access to Medicines

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By Adriana Benedict

Last week, Public Citizen published a Health GAP analysis entitled “Leaked TPP Investment Chapter Presents a Grave Threat to Access to Medicines,” in which Professor Brook Baker explains four ways in which access to medicines is compromised by the USTR’s leaked investment chapter proposal for the Trans-Pacific Partnership Agreement.  The problematic provisions he identifies — inclusion of intellectual property (IP) in the definition of “investment”, ambiguous scope of minimum standards of treatment, inadequate exceptions and limitations for public interest measures, and performance requirement limitations preventing development of local and sustainable production—are not new, but have been included either implicitly or explicitly in countless bilateral investment treaties (BITs) (including the U.S. Model BIT) and the investment chapters of free trade agreements (FTAs) (including virtually all US FTAs and the proposed EU-India FTA).  Such inclusion gives more “teeth” to foreign investors’ IP rights, but what of access to medicines?

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Sunder on Patents and Access to Drugs

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By Frank Pasquale

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  “I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

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