Caplan on Pediatric Anthrax Vaccine Trials

Art Caplan has a new column responding to the latest report from the Presidential Commission for the Study of Bioethical Issues.  Take a look:

A top-level commission has just released a new report on the morality of studying the safety of an anthrax vaccine in children, with an eye toward treating kids in the event of a terror attack.

The report, issued Tuesday by the Presidential Commission for the Study of Bioethical Issues, is quite thoughtful. It concludes that no testing should be considered unless the risk to kids is minimal. But it also represents a study of an experiment that has no chance of happening — ever. The commission has wasted its time. There is not a chance that a sufficient number of American parents are going to sign up their kids for the safety testing of an anthrax antidote.

Keep reading…

Reminder, Upcoming Conference on Universal Health Coverage in Low-Income Countries

A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.

AGENDA

https://peh.harvard.edu/events/2013/universal_coverage/agenda.html

REGISTRATION

No fee. Space limited. Registration required. Please register on our registration website.

The U.S. Should Cover the Cost of IVF (for Gays and Lesbians Too)

By Dov Fox

Glenn Cohen and I make the case in this morning’s Huffington Post:

This week the United Kingdom joined the ranks of countries like Canada, Israel, and Sweden that provide in vitro fertilization (IVF) treatment to citizens under a certain age (42 in the U.K.) who can’t have children without it. That includes gays and lesbians. When it comes to helping people form the families they long for, the United States is woefully behind. The U.S. has among the lowest rates of IVF usage of any developed country in the world, owing in part to boasting the highest cost for the procedure, on average $100,000 for each successful pregnancy.

Among the handful of states that require insurers to cover IVF, many carve out exclusions for same-sex couples and people who aren’t married. These singles, gays, and lesbians are sometimes called “dysfertile” as opposed to “infertile” to emphasize their social (rather than just biological) obstacles to reproduction. The U.S. should expand IVF coverage for the infertile, and include the dysfertile too.

The U.S. Supreme Court has held that the inability to reproduce qualifies as a health-impairing disability under the Americans with Disabilities Act. The commitment to universal health care that we renewed in President Obama’s health reform act invites us to understand the infertile and dysfertile alike as needing medicine to restore a capacity—for “[r]eproduction and the sexual dynamics surrounding it”—that is, in the words of the Supreme Court, “central to the life process itself.”

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Registration Now Open: Petrie-Flom Annual Conference


Petrie-Flom Center Annual Conference:

The Food and Drug Administration in the 21st Century 

Friday and Saturday, May 3-4, 2013

Harvard Law School, Cambridge, MA

The Petrie-Flom Center invites you to attend our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.”  Attendance is free and open to the public.  Registration required; space is limited.

Conference Description

The Food and Drug Administration, the US government’s oldest comprehensive consumer protection agency, bears the monumental task of safeguarding the public health through regulation of food, drugs and biologics, devices, cosmetics, animal products, radiation-emitting products, and now, tobacco. The agency faces a number of perennial issues related to funding, relationships with industry, and striking the proper balance between consumer choice and consumer protection. It also faces several modern challenges related to globalization, novel technologies, newly added responsibilities, and changing threats to the public health.

How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?   This conference will  gather leading experts from academia, government, and private industry to evaluate the FDA based on these and other questions, and to begin charting a course for the agency’s future.

Conference Sessions

* For the full conference agenda, including speakers, presentation titles, and specific times, please click here. *

DAY 1 – Friday, May 3, 2013, 9:00-5:00

  • Welcome and Introduction
  • PLENARY 1 – PETER BARTON HUTT (Covington & Burling)
  • The FDA in a Changing World
  • Preserving Public Trust and Demanding Accountability
  • LUNCH AND KEYNOTE (TBD)
  • Protecting the Public Within Constitutional Limits
  • Timing Is Everything: Balancing Access and Uncertainty
  • Major Issues in Drug Regulation

DAY 2 – Saturday, May 4, 2013, 9:00-4:00

  • Welcome
  • PLENARY 2 – ALTA CHARO (University of Wisconsin Law School)
  • Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
  • Major Issues in Device Regulation
  • LUNCH AND PLENARY 3 – SUSAN WINCKLER (President and CEO, Food & Drug Law Institute)
  • Major Issues in Food, Supplement, and Tobacco Regulation
  • Addressing the Challenges of and Harnessing New Technologies
  • Closing Remarks

Register Now!

Questions: petrie-flom@law.harvard.edu; 617.496.4662.

Is Obama Winning or Losing on Medicaid Expansion Under the Affordable Care Act?

By: Katie Booth

The Obama administration announced in February that it would allow Arkansas to use the federal money intended for Medicaid expansion to buy private health insurance plans for individuals with incomes up to 133% of the federal poverty level. This week, Florida’s senate rejected the Medicaid expansion but left open the possibility that it would try to negotiate a similar deal with the Obama administration. Indiana and Ohio may follow suit.

At first glance, this seems like a political loss for Obama. Several states with Republican governors may now expand healthcare for the poor using a private payer model—the type of model Mitt Romney supported during the 2012 presidential race. Yet Obama’s compromise in Arkansas may ultimately be a win for the president. All of the 14 states that are not participating (as of now) in the Medicaid expansion have republican governors. The private insurer model would allow these governors to save face while ultimately expanding access to healthcare for the poor.

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Petrie-Flom Interns’ Weekly Round-Up: 3/09-3/15

By Hyeongsu Park and Kathy Wang

  • As individual states continue their internal political debates over state-by-state Medicaid expansion, Florida’s Senate Committee rejected the measure. However, the panel continued to debate a possible compromise that would allow the state to receive more federal funding while also encouraging citizens to seek alternative options to Medicaid.
  • An opinion piece in the New York Times called for holding generic drug manufacturers more accountable for damaging side effects. The case of Mutual Pharmaceutical Co. v. Bartlett will be argued this month in the Supreme Court. Bartlett, who experienced painful, debilitating effects from taking a generic drug manufactured by Mutual, is seeking to hold Mutual liable for its defective drug design.
  • A new UN report frames bioethics from another point of view, calling for its application as an “anti-torture” ethic. This report on torture and healthcare phrases many of the health and rights violations of torture practices as important bioethical considerations.
  • In the international sphere, the Australian state of Tasmania has taken steps to liberalize its abortion laws.
  • As debate swirls around the mandatory labeling of foods with GMO ingredients, Whole Foods has announced that it will require such labels in all its stores by 2018.
  • Pharmaceutical and biotechnology companies are expecting a litigious year, as reported by a survey of chief IP counsels working in the industry. This highlights the growing importance and conflict over the protection of patents and intellectual property in the sector.
  • Small businesses have been trying to exploit a “loophole” in the ACA requirement for small business health insurance marketplaces by offering self-insurance. This practice, more typical of large companies, allows small businesses to simply pay most of their workers’ health expenses directly.
  • Employers are protesting a fee charged by the federal health care law, which would require them to pay $63/person that they insure. This fee was intended to offset the cost of covering people with high medical bills, but opponents claim it is unfairly subsidizing individual plans.

March 28: Jessica Flanigan speaking to the HMS Division of Medical Ethics

Please join the HMS Division of Medical Ethics for …

 

“Why patients should have access to all drugs without a prescription”

Jessica Flanigan, PhD

Assistant Professor of Leadership Studies and Philosophy, Politics, Economics and Law

University of Richmond

Thursday, March 28, 2013; 4:00 – 5:30 PM

HMS Division of Medical Ethics

1st Floor Conference Room

641 Huntington Avenue, Boston

RSVP to DME@hms.harvard.edu

Jessica Flanigan is a philosopher whose research interests include the ethics of business and medicine, law, and public policy.  Her current research addresses the ethics of self-medication and looks at the obligations of business leaders, particularly in the pharmaceutical industry, and questions the role of public officials. She asks questions such as: Can business leaders harm consumers simply by giving them more options? Do public officials misuse their power when they prohibit potentially dangerous drugs?  She is working on a book, Liberal Medicine, which is the first sustained philosophical inquiry into the ethics of medical regulations such as premarket safety and efficacy trials and the prescription drug system.

REMINDER – Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard:

Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

May 17, 2013, 8:00AM-5:00PM

Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor)

1585 Massachusetts Ave., Cambridge, MA

Our current agenda/objectives are below the fold, and will be updated with additional detail shortly.  Please make sure to register as space is limited! 

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Caplan on Guns, Mental Health, and NY State Law

In a new article (free registration required), Art Caplan discusses recent gun control legislation passed in New York state.  Take a look at the full piece, but here’s an excerpt:

The NY SAFE Act requires individuals who own a handgun or an assault rifle to recertify their permits every 5 years; limits the capacity of ammo clips to 7 shots; clarifies and broadens the definition of assault weapons to restrict their sale; and requires nearly all gun transfers between private parties to be conducted through a federal firearms licensee, subject to a federal National instant Criminal Background Check. These are predictable, if tough to enact, actions when it comes to guns. What is somewhat surprising is that the law imposes new duties on mental health care professionals that will also be very difficult to implement.

Under the New York legislation, mental health professionals are required to report to local mental health officials when there is reason to believe a patient is likely to engage in conduct that will cause serious harm to himself or herself or to others. This information will then be cross-checked against a new gun registration database. If the patient possesses a gun, his license will be suspended and law enforcement will be authorized to remove the person’s firearm.

Kendra’s law, enacted in 1999, is extended for 2 years—through 2017. This law gives judges the authority to require people to regularly under-go outpatient psychiatric treatment. Under the NY SAFE Act, the period of mandatory outpatient treatment is extended from 6 months to 1 year.

There has long been a legal obligation in most states, generated by the famous 1976 Tarasoff case in California, that mental health care professionals disclose a threat of violence to an identifiable third party if they think the threat is credible and the act imminent. Both before and after Tarasoff, there have been ethi-cal and clinical obligations. The new NY SAFE Act would transcend New York State’s mental hygiene statute granting an “authority to warn” into a legal duty if the clinician believes that firearms may be involved. The problem is that there is not much evidence that mental health workers are particular adept at predicting violence. It remains to be seen if this reporting duty will produce greater public safety in New York.

Rethinking Biotechnology and Software Patents: A Myriad of Jurisdictional Issues Related to Subject-Matter Eligibility

by Adriana Benedict

Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I arrived at this conclusion about the doctrine’s implications for Myriad:

According to Mayo v. Prometheus, the preemption rationale for the natural phenomenon doctrine suggests that any patent on a diagnostic biotechnology product or process should be limited to the inventive use of that product or process as defined by its associated process or product, respectively.  As applied to Myriad, this qualified interpretation of the natural phenomenon doctrine would suggest that ideally these patents ought to be limited to Myriad’s one remaining valid method claim, namely claim 20 of the ‘282 patent, “a method for screening potential cancer therapeutics.”  The unavoidable and unsettling problem with such a conclusion, of course, is that at this stage in litigation, it is not possible for the Court to limit Myriad’s gene patents in this way.  This procedural limitation sheds some light on the elephant in the natural phenomenon doctrine: If the doctrine was meant to exclude certain categories of discoveries from patentability before Congress had the opportunity to refine more specific patent validity rules, then perhaps it should be limited to carrying out that function at the outset of a patent prosecution.  The natural phenomenon doctrine serves the important purpose of ensuring that patents do not contravene their Constitutional objective by too broadly preempting the use of “basic tools of science.”  It does so by balancing the scope of preemption against the scope of invention, and ensuring that the scope of preemption does not exceed that which is justified by the inventor’s handiwork in applying natural phenomena.  At the patent prosecution stage, the natural phenomenon doctrine is a useful “catch-all” analytical tool that allows flexibility in promoting the spirit of patent law when the letter of patent law has not kept pace with the progress of science. But at the litigation stage, its Achilles heel is that it may prove too much: In the absence of a procedural option to limit a patent at this stage, the natural phenomenon doctrine is forced to err on either the side of all or nothing.  While the doctrine may be useful at the patent prosecution stage, it was not (as other statutory patentability requirements were) appropriately designed to assess the validity of patents once they’ve been issued in a way that is compatible with today’s patent litigation procedures.  As a doctrine of limitation, it must in this context either fall, and prove nothing at the expense of unwarranted preemption, or rise, and prove too much at the expense of patent holders who have been reasonably relying on guidance from the USPTO regarding gene patents for many years.  

I am unable to find any commentary exactly on this point, but some issues concerning the jurisdictional authority of §101 have been raised in response to both Mayo and CLS Bank v. Alice.  While these cases concern biotechnology processes and software, respectively, they are extremely relevant to Myriad if we consider isolated genes / cDNA to be the equivalent of biological software. Indeed, Professor Ronald Mann observed that “Though most of the attention to …[Mayo]  has focused on its immediate implications for medical providers, the broader effect of the case probably will be on the software industry.”

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