Resources on the Future of Gene Patenting

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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.]

Art Caplan on emergency meningitis vaccines at Princeton

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Art Caplan has a new piece at bioethics.net on Princeton’s plan to import and administer a meningitis vaccine not approved for use in the US in an effort to curb an outbreak of meningitis B that has already sickened several students.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that does protect against meningitis B.  And that decision seems entirely reasonable given the threat that this nasty strain of meningitis poses.

That said, the question arises — what should those getting the vaccine be told?  Are they being offered a proven vaccine, an experimental vaccine, a vaccine believed to be the best choice given the threat of an epidemic or something else?  Can a student, campus worker or faculty member refuse the vaccination and stay in school or in a dorm?  Should those who have visited the campus recently be tracked down and offered the vaccine?  If people do refuse should they identify themselves in anyway as unvaccinated and to whom?

Read the full article here.

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.

UPDATED: Applying NFIB v. Sebelius in the Federal Circuits: Analysis of the Case Law

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By Jeremy Kreisberg

More than one year has passed since the Supreme Court decided NFIB v. Sebelius, the major case concerning the constitutionality of the individual mandate and Medicaid expansion.  As you might remember, the Supreme Court upheld the individual mandate as a valid exercise of Congress’s taxing power, but Chief Justice Roberts and the four Justices in the joint dissent wrote that Congress did not have the power under the Commerce Clause to compel individuals to enter the health insurance market. Importantly, the Court drew a distinction between activity and inactivity, finding that Congress could not regulate the latter.  Some argued that this decision may have wide implications for other regulatory efforts by Congress.

Unsurprisingly, it did not take long for litigants to begin using the Court’s Commerce Clause analysis in an attempt to invalidate other federal statutes.  I undertook a review of federal circuit cases that have applied (not merely cited) NFIB‘s Commerce Clause analysis to determine how these litigants have fared.  After the jump, I have categorized the cases I found into those discussing the validity of criminal statutes and those discussing the validity of federal regulations on states (please let me know in the comments section if I missed some).  The main takeaway from my review is that, as of today, no circuit court has used NFIB as its justification for striking down a statute under the Commerce Clause.

But before I get there, I should note from the outset that it is not clear whether the Court’s “decision” on the Commerce Clause is binding on future courts.  David Post at the Volokh Conspiracy has a rather compelling take on why the Court did not need to reach the Commerce Clause issue, and thus that portion of the decision should be viewed as mere dicta.  Of course, Chief Justice Roberts insisted that the Commerce Clause portion of his opinion was necessary because that the most natural read of the statute did not lend itself to review under the Taxing Power, and only after deciding the Commerce Clause issue was he willing to construe the statute otherwise.  Post responds to that argument here.  On my review of the federal circuit cases, no circuit has actually reached the merits of this issue (although at least a couple of these courts have mentioned the issue without deciding it, and one court — the Ninth Circuit in United States v. Henry — even cited to David Post’s second article cited above).  I intend to take a broader look at the district court cases to determine whether a federal court has addressed this issue; I’ll have that post for you all in the near future.

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Compensation for a Patient’s Lost Chances to Recover from Illness: A Redux

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By Alex Stein

Three days ago, Washington’s Court of Appeals issued a decision explaining the state’s Supreme Court precedents that entitle patients wronged by their doctors to recover compensation for their lost chances to recover from illness: Herskovits v. Group Health Cooperative of Puget Sound, 664 P.2d 474 (Wash. 1983), and Mohr v. Grantham, 262 P.3d 490 (Wash. 2011). The Court of Appeals ruled that this compensation entitlement is limited to cases in which the injured patient cannot prove causation by a preponderance of the evidence due to her preexisting condition. The Court explained that when a doctor’s malpractice reduces the patient’s chances to recover by more than 50%, the patient would be able to satisfy the preponderance requirement and recover full compensation. The Estate of Ruth M. Dormaier v. Columbia Basin Anesthesia, P.L.L.C., — P.3d —-, 2013 WL 6037098 (Wash.App. Div. 3 2013).

This decision also has continued the prevalent, but mistaken, “arithmetical approach” to lost chances. Under this approach, when a doctor’s malpractice reduces his patient’s chances to recover from illness from 75% to 25%, and the patient ultimately does not recover, the doctor must pay the patient 50% (75%-25%) of her damage.

This approach is mistaken for the following reasons: Read More

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.

George at APHA IV: Happy George

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By Scott Burris

This is the last in a series summarizing a panel from the George collaborative of law professors at last week’s APHA meeting. My talk had a smiley icon for a title and a rant for a structure. I wanted to engage the audience with two very general ideas:  that public health legal interventions are popular, and that we are both factually and strategically wrong to buy into the framing of public health law controversies as turning on principled questions of paternalism or tensions between individual rights and collective welfare.

The first is a point I have made in past posts of one kind or another, and that Evan Anderson and I elaborate in our article just published in the Annual Review of Law and Social Science.  In that article, we point to the fact that Rs and Ds have been happily passing laws that regulate our behaviors, our environment and our machines for public health reasons for decades and show no signs of slowing down. In the talk, I also reference the Morain and Mello Health Affairs piece on pro-public-health public opinion. At PHLR, we are working on another aspect of all this, the fact that a lot of the controversy and complaint about “intrusive” measures often dies down once the new behavior is adopted.  We don’t have a paper on this yet, but just ask yourself who misses smoke-filled rooms, transfats, cars without airbags…   And of course, as Mayor Bloomberg makes his exit as the symbol of the local nanny state, it’s worth recalling his poor paterniated charges re-elected him twice.

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George at APHA III

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By Scott Burris

One of the themes of what we might call Georgian Legal Scholarship has been the neglect of public health as a core object of government. This is a theme Wendy Parmet set out at length in Populations, Public Health and the Law, and that Renee Landers took up at APHA.

Landers’ timely example was the ACA and its individual mandate, which has been characterized in litigation as a mandate to purchase an “unwanted” product in violation of individual liberty, exceeding Congress’s power under the Commerce Clause, not a valid exercise of Congress’s Taxing Power, and an intrusion on the prerogatives of the States.  The Chief Justice’s opinion in the Supreme Court’s decision in NFIB v. Sebelius, upholding the individual mandate, but declaring the structure of the Medicaid expansion a violation of the Tenth Amendment, provides her many examples of the focus on these legal abstractions. She also points to language from the joint dissent that indicates the same limited perspective.   Absent from the opinions was acknowledgment of the significant public health problems—human suffering—that the ACA was designed to address.  As she sees it, a focus on abstractions over lived experience has resulted in millions of intended beneficiaries of the ACA being left out of the Medicaid expansion because 26 states have taken advantage of the ability to opt out of the Medicaid expansion.

Landers argued that this was not a problem confined to the ACA case. Courts have reasoned in similar ways in recent public health preemption, First Amendment and abortion cases, showing a disregard for real human situations or scientific and economic evidence.   To her, these recent examples echo the approach of the courts in the early part of the twentieth century when the Lochner case defined judicial review of economic and public health regulation, as Wendy Parmet has discussed in Populations, Public Health, and the Law.  Public health lawyers and scholars, she concluded, must work to demonstrate for courts that role of economic regulation in promoting the public health, elevate the concerns of real people above legal abstractions, and lift the mask on punitive measures masquerading as public health laws.

Tomorrow: Happy George

More thoughts on the legality of the like it/keep it fix.

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Yesterday, President Obama held a lengthy press conference in which he took responsibility for recent problems in the implementation of the Patient Protection and Affordable Care Act and announced that the Administration would allow health insurers to re-establish certain canceled plans for 2014 even if they do not comply with the PPACA.  Specifically, he said “we’re going to extend [the principle behind the grandfather clause] both to people whose plans have changed since the law took effect and to people who bought plans since the law took effect.”

Jonathan Adler at Volokh, co-blogger Chris Robertson here at Bill of Health, Nicholas Bagley at The Incidental Economist, and Seth Chandler at ACA Death Spiral, have all offered thoughts on the legality of the President’s decision to grandfather administratively plans that were being canceled for non-compliance with certain PPACA requirements.  House Speaker John Boehner, for his part, said of the move: “I’m highly skeptical they can do this administratively.  I just don’t see within the law their ability to do it.”

I’ve a few thoughts of my own to add on the prospects for a successful lawsuit challenging the fix: Read More

PRIM&R 2013 Advancing Ethical Research conference report: The Value of Hope and the Therapeutic Misconception

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By Lauren A. Taylor, Coordinator for Health and Religion in the Global Context, Harvard Divinity School and co-author of The American Health Care Paradox: Why Spending More Is Getting Us Less(PublicAffairs, 2013).

Following his keynote address, on which Melissa has already blogged, Paul Applebaum responded to an extended set of audience questions over lunch at the PRIM&R Advancing Ethical Research conference on Friday.

Among the questions asked of him, one stood in stark relief to the general tenor of the event. While many participants had taken hold of the microphone to commend Applebaum on his remarkable career pursuing this idea of ‘therapeutic misconception’ among clinical trial enrollees, a female participant took a different path. She asked if he had ever considered the possibility that people needed to misconceive the trial, on some psychological level, for their own survival. In so doing, she drew into question an entire previous discussion that had focused on ways in which the research community could work more effectively to inform clinical trial enrollees of the risks posed to their health and slim chances at recovery.

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