Category: Biotechnology

Genetically Modified Crops

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The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Read More

Art Caplan: ‘Life support’ is wrong for brain-dead pregnant woman

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Art Caplan has a new piece at NBC News online weighing in on the case of Marlise Munoz, the pregnant Texas woman who was declared brain dead by doctors several weeks ago and yet is being kept on “‘life support’ technology” against her family’s wishes. Based on their reading of a Texas law that bans the withdrawal of such machines in cases where the patient is pregnant — regardless of advance directives or the family’s wishes — the hospital claims it has no choice. Caplan argues:

The hospital, however, is very confused. If Marlise is dead, then the Texas law does not apply. Even the legislature of Texas cannot compel continued use of medical interventions on a dead body. “Life support” technology need not be continued if the patient is dead. Erick Munoz made that case in his lawsuit against John Peter Smith Hospital.

“In fact, Marlise cannot possibly be a ‘pregnant patient’ — Marlise is dead,” the suit says. “To further conduct surgical procedures on a deceased body is nothing short of outrageous.”

But even if Marlise were alive — assuming she has either a terminal or irreversible condition — the hospital has the choice to do the right thing ethically, follow the wishes of her husband and family and stop intervening.

Read the full article.

 

Petrie-Flom Center Seeks Harvard Law School Student Interns for Winter/Spring 2014

The Petrie-Flom Center Staff Leave a comment

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns to start immediately for the upcoming winter and spring terms beginning in January 2014.   We may consider extension through Summer 2014 if there is mutual interest.

Harvard Law School students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. We particularly welcome applications from students with a background in health policy, philosophy, bioethics, health law, medicine, business economics, and the sciences.

To view the full call for applications, please visit our website.

New Book: “Science and Technology in International Economic Law”

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I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific region, Middle East, and Europe. It is the first attempt to explore the status and interaction of and between science, technology and international economic law (namely, trade and investment) with a view to seeking a proper balance between promoting trade/investment liberalization and ensuring that decisions are soundly based and that technological advancement is not hampered.

On the issue of food safety, scientific evidence and trade disputes, I contributed a paper, titled ”Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making,” which appeared previously in the Food & Drug Law Journal, Vol. 68, pp. 97-114 (2013).

The following reveals a brief background and objective of the book:

Read More

Capturing Value in Advanced Medical Imaging

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On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Two Pills: “That Will Be $307,000, please.”

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By Christopher Robertson

So reads the cover of the MIT Technology Review this month.  The article is available for free online.  The article begins with the story of Kalydeco, which is priced at $294,000 per year.

The company also pledged to provide it free to any patient in the United States who is uninsured or whose insurance won’t cover it. Doctors and patients enthusiastically welcomed the drug because it offers life-saving health benefits and there is no other treatment. Insurers and governments readily paid the cost.

Hold on.  If patients can get the medicine for free even when their insurers decline to pay the cost, why would insurers “readily pay the cost?”

1/31: Second Annual Health Law Year in P/Review conference

The Petrie-Flom Center Staff Leave a comment

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

Ethics and Oversight in Recombinant Genetic Research

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By Michael Young

In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule.  These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules.  Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974.  The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).

Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”

The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Read More

The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

The Petrie-Flom Center Staff Leave a comment

Cross-post from PointOfLaw.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Read More