Reminder, TODAY – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

TODAY!
12-1:30pm
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.

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

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

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.

Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1

It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week.  Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics?  I think this may be the case.

Perhaps most importantly, frozen oocytes will not implicate personhood laws.  Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses.  However,  IVF clinics and clinicians should also be concerned.  It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos.  There have been no such criminal proceedings brought against an IVF clinic — yet.  Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist.  Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.

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Fixing Genes Using Cloning Techniques

One more from Art Caplan:

Fixing genes using cloning technique is worth the ethical risk

A team of scientists at the Oregon National Primate Research Center and the Oregon Health & Science University are reporting a remarkable advance in the treatment of inherited genetic disease in the journal Nature.

They show it is possible to repair a tiny part of a human egg cell that, when broken, causes a host of awful inherited genetic diseases.  Those diseases cause disability and the death for many children and adults.  What is equally remarkable is that the treatment they report is illegal in Britain, Germany, Costa Rica, Norway and Sweden and would be illegal to provide using federal dollars in the United States.

What did the Oregon scientists do?  And why is it so ethically controversial?

Keep reading…

Life Extension: Forcing Criminals to Serve Their Time? (Part I)

By Yu-Chi Kuo

Former Penn State football coach Jerry Sandusky was recently sentenced to 30 to 60 years in prison for serial child sex abuse.  Sandusky had faced as great as a 400-year potential sentence during trial, but even the 30 year minimum term will likely exceed his natural lifespan all the same: at 68-years-old, Sandusky will probably die in prison long before serving his time. If he lives to the average life expectancy of 75, he will have served only a quarter of his minimum sentence.  In light of the vileness and severity of his crimes, Sandusky’s death may leave many victims and observers feeling that death provided an early exit from deserved punishment.

Curiously enough, Sandusky’s former employer patented and licensed a telomerase reporter system capable of monitoring the regulation of telomere maintenance. Telomeres are microcellular regions that protect against gene degradation and promote cell longevity. The maintenance (or lengthening) of telomeres through telomerase therapy is an exciting subfield of life-extension therapy that may radically lengthen human lifespans in future.

The arguments for and against this and other forms of human enhancement technology are fairly well combed-over in popular discourse: it’s unnatural; it’s sinful; it’s unfair; it’s arrogant. On the other hand, this and other subfields of gerontology profess some noble goals: to improve the ratio of “good years” with years of morbidity; to deliver unto humans a “gift” of possibly unlimited life.  But what if we inverted the concept of life extension therapy as a “gift,” and could administer it to criminals like Jerry Sandusky, in order to extend their remaining life up to the end of their sentence? Telomerase therapy may be a continual treatment; it could conceivably even be withdrawn to give the old man just enough “life” to watch the clock on his last day.
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FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

Nice Jotwell review of former Petrie-Flom Fellows’ article “Does Agency Funding Affect Decisionmaking?: An Empirical Assessment of the PTO’s Granting Patterns”

Over at Jotwell, Michael Carroll (American) has a very nice review of a new paper that is a collaboration between two of our former fellows at the Petrie-Flom Center, Michael Frakes (Cornell) and Melissa Wasserman (Illinois).

Their article is Does Agency Funding Affect Decisionmaking?: An Empirical Assessment of the PTO’s Granting Patterns, 66 Vand. L. Rev. (forthcoming, 2013).

Here is the abstract of that paper:

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PCSBI: Privacy and Progress in Whole Genome Sequencing

Yesterday, President Obama’s Commission for the Study of Bioethical Issues released its fifth report: Privacy and Progress in Whole Genome Sequencing.  I haven’t had a chance to digest it yet, but for now, just wanted to call it to everyone’s attention.  The gist seems to be privacy, privacy, privacy.

Here are the major recommendations, straight from the Commission’s “mouth”:

Recommendation 1.1
Funders of whole genome sequencing research; managers of research, clinical, and commercial databases; and policy makers should maintain or establish clear policies defining acceptable access to and permissible uses of whole genome sequence data. These policies should promote opportunities for models of data sharing by individuals who want to share their whole genome sequence data with clinicians, researchers, or others.

Recommendation 1.2
The Commission urges federal and state governments to ensure a consistent floor of privacy protections covering whole genome sequence data regardless of how they were obtained. These policies should protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample came.

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Call for Papers – Petrie-Flom Center Annual Conference: The Food and Drug Administration in the 21st Century

We are pleased to announce plans for our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.”  This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. For details on the event and the call for proposals, see the Call for Papers/Presentations. Abstracts are due no later than December 10, 2012.