Category: Biotechnology

DUE MONDAY: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center Staff Leave a comment

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Calls for abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

Fox interviewed on NPR about FDA’s Ban on Direct-to-Consumer Genetic Testing

Dov Fox Leave a comment

Bill of Health Contributor Dov Fox was interviewed today on NPR’s “Marketplace” about the FDA’s decision to ban all sales of direct-to-consumer genetic testing by 23andMe.

23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.

“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”

Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor.  According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”

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DUE IN ONE WEEK: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center Staff Leave a comment

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

GM Food Labeling: An Unfinished Battle

The Petrie-Flom Center Staff Leave a comment

By Kuei-Jung Ni

In Washington state, a proposal (Initiative 522) to require labeling of genetically modified (GM) or engineered (GE) foods was defeated recently by votes of 45.17% in favor and 54.83% against. The state law would have implemented mandatory labeling requirements on food composed of 0.9% or more of GM ingredients, measured by weight. Prospects for passage of the proposal were quite promising when it was first introduced. But, the scenario shifted when GM food companies, including General Mills, Nestle USA, PepsiCo, Monsanto, etc., launched a multi-million dollar advertisement campaign challenging the justification for GM labeling.

The downfall of the proposal, while disappointing consumer groups, is not likely to stop the labeling movement. Actually, there have been many other attempts to regulate GM foods on a state level. California Proposition 37, which would have imposed labeling requirements similar to the Washington proposal, was put to a vote last year, but failed to pass. According to Just Label It, a NGO, more than 20 state laws were introduced about GM labeling this year.

Many scientists trust the safety of GM foods, and the benefits brought by the development of GM agriculture are obvious. GM crop production can reduce the use of pesticides and enhance yields. By contrast, in addition to possible new allergies caused by the consumption of GM foods, some worry about their potential harm to the environment and ecological system. On the federal level, three agencies are competent to regulate GM crops and foods: the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which use existing rules to regulate. Yet, the inadequacy of their oversight has been disclosed. Until now, no specific federal law has been enacted to regulate GM food production and consumption.

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CORRECTED DATE: 12/2: Petrie-Flom Health Law Workshop with Christopher Robertson

The Petrie-Flom Center Staff Leave a comment

Christopher Robertson is an associate professor at the James E. Rogers College of Law, University of Arizona and an associate with the Safra Center for Ethics at Harvard. For 2013-2014, he is a visiting professor at Harvard Law School. He is also a regular contributor at Bill of Health.

He will present two papers at the Petrie-Flom Health Law Workshop on Monday, December 2, at 5:00pm: “Scaling Cost-Sharing to Wages” and “A Presumption against Expensive Healthcare Consumption.”

For more details on the workshop, including information on how to obtain copies of the papers, please visit the Petrie-Flom Center’s website.

TOMORROW: Neil Flanzraich, “Responsibility and Integrity in the Pharmaceutical Industry”

The Petrie-Flom Center Staff Leave a comment

Please join the Petrie-Flom Center for a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies.  There will be substantial time for Q&A.

Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.

For more information, please visit our website.

Video now available of panel on “Reproductive Rights around the Globe”

The Petrie-Flom Center Staff Leave a comment

Video of the panel discussion “Reproductive Rights around the Globe,” held at Harvard Law School on November 7, is now available via the Petrie-Flom Center’s website. The panel — cosponsored by the Petrie-Flom Center; the Human Rights Program; and the Child Advocacy Program at Harvard Law School; and the Harvard Global Health Institute — included legal experts on a variety of topics:

  • International trends in gamete donor identifiability v. anonymity – I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty co-Director, Petrie-Flom Center
  • The politics of evidence and expertise in domestic and international abortion litigation – Aziza Ahmed, Associate Professor of Law, Northeastern University School of Law; Visiting Scholar, Petrie-Flom Center (Spring 2014)
  • Use of international fora, including courts and treaty bodies, to advance reproductive rights – Mindy Jane Roseman, Lecturer on Law, Harvard Law School; Academic Director, Human Rights Program
Link to the video here.

Resources on the Future of Gene Patenting

Leslie Francis Leave a comment

By Leslie Francis

At the University of Utah, our Center on Law and Biomedical Sciences was fortunate to be able to hold a recent symposium on the future of gene patenting. Our speakers included Ken Chahine and Amelia Rinehart, both faculty at the College of Law, presenting accounts of the science and patent law; Brian Dawson, co-director of the molecular genetics lab at the Mayo Clinic, and Elaine Lyon, co-director of pharmacogenomics at ARUP and incoming president of the Association of Molecular Pathologists, speaking from the perspectives of laboratory directors and the Association of Molecular Pathologists; John Meija, legal director of the ACLU of Utah, speaking on patients’ rights; Wendy Kohlmann, manager of genetic counseling at the Huntsman Cancer Center, considering the ethical dilemmas for genetic counselors confronted by intellectual property restrictions; and Benjamin Jackson, senior director of legal affairs at Myriad Genetics, speaking from the perspective of Myriad. A recording of the symposium can be found here.

For those wishing to follow ongoing developments in gene patenting, we have prepared a libguide with resources on the Myriad decision and ongoing gene patenting cases.

[Leslie Francis]

[This is a cross-post from the HealthLawProf blog.]

Going On Now: IOM Stem Cell Therapies Workshop

The Petrie-Flom Center Staff 1 Comment

The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings.  You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived.  Our own Glenn Cohen is slated to discuss stem cell medical tourism at 1:15 this afternoon.

Here’s the description from the IOM site:

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer “stem cell therapies” for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.

The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.

How Well Do You Know Your Turkey?

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by Efthimios Parasidis

In the United States, over 250 million turkeys are slaughtered each year, with over 45 million just for Thanksgiving. The overwhelming majority of these birds (over 99%) are a genetically engineered and industrially-farmed breed known as Broad Breasted White. As the name suggests, this breed of turkey has an unnatural abundance of white breast meat.  In many ways, industrial turkey farms are similar to industrial chicken farms–typically there are thousands of birds packed into a closed space with no natural light, no access to the outdoors, and mechanized feed and water (often laced with antibiotics and growth hormones). Adult turkeys in an industrial farm typically cannot walk properly or reproduce on their own, and artificial insemination is the norm. The eggs are hatched in an incubator and newborns have no contact with their mother. Shortly after birth, the young turkeys are placed into a large dark warehouse that will be the only space they will ever know. Their toes and beaks are cut without pain killers. Due to the grotesque environment, millions of birds die from “stress-induced conditions“. Those that survive grow at an astonishing rate, attaining market weight in just 12-18 weeks. The adults often are blind, due to lack of natural light and other factors (such as pecking fights in the tight quarters). According to one study, if a 7 pound human newborn grew at the same rate as an industrial turkey, it would be 1,500 pounds at 18 weeks of age.

A small but growing number of turkeys are non-genetically engineered Heritage Breeds. Heritage Breeds were in existence prior to the industrial-farming practices introduced in the 1960s, with some breeds tracing their roots to the 1800s. Standard farming practices for Heritage breeds include liberal roaming of pastures, humane growing conditions, and no antibiotics or growth hormones. Heritage turkeys are difficult to find, with some farmers requiring advanced notice (often months in advance) to purchase. The higher cost of Heritage turkeys (about $7 a pound, compared to approximately $1.50 a pound for industrial birds) reflects the higher cost of raising them, as well as insufficient subsidies for farmers employing organic and/or sustainable practices (along with over-subsidization of industrial and corporate farms).

It’s important to note that an organic turkey is not necessarily a Heritage breed. An organic turkey is any breed that has been fed an organic diet. Similarly, a free-range turkey is not necessary a Heritage breed. In fact, free-range does not mean that the turkey has actually stepped foot on a pasture. Rather, under USDA regulations, a bird can be labeled free-range if it lives in a space where there is access to the outdoors. Reaching the outdoors is immaterial. If knowing your turkey matters to you, be sure to ask the right questions, including the breed of the turkey, what feed the turkey has been provided (including whether the feed was comprised of genetically-modified ingredients), whether the turkey has been given antibiotics or other drugs or hormones, and whether the bird actually foraged in a pasture.