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

Petrie-Flom Intern’s Weekly Round-Up: 12/1-12/8

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By Chloe Reichel

1) Following orders from FDA, 23andMe will no longer market genetic tests using health analyses. The company will, however, continue to sell genetic tests related to ancestry.

2) Families with children who have seizure disorders are flocking to Colorado. There, these children can legally receive medications containing extracts from marijuana, which are believed to reduce the occurrence of seizures.

3) A bill is being debated in the New York City Council that would ban the use of electronic cigarettes in public spaces. Supporters of the ban say that electronic cigarettes pose a public health risk, while opponents say that they are harmless.

4) Chemotherapy will not be forced on an Amish girl with lymphoblastic lymphoma. The family decided to stop treatment because of the side effects, and the court-appointed guardian of the girl has decided to drop the case against her parents because they are not locatable.

5) Error rates for those who filled out enrollment forms on the Healthcare.gov online insurance marketplace were at 25 percent for October, although representatives say that these error rates have since declined.

6) Legislators who are opposed to the Affordable Care Act are planning to utilize funds allocated by the federal government for Medicaid expansion to instead purchase private health insurance plans for people who are of low socioeconomic status. This Friday, Tom Corbett, governor of Pennsylvania announced this plan, and Arkansas legislators have already enacted an analogous plan.

Could the Patient Protection and Affordable Care Act Have a Legitimacy Problem?

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Public skepticism about the Patient Protection and Affordable Care Act could in a sense turn out to be self-fulfilling.  The success of the Exchanges will depend in large part on how many people enroll in them, that is, how many people comply with the individual mandate and sign up for insurance rather than take the tax penalty.  That is why we are starting to talk more and more about how many people will wind up enrolling; it’s important.  (For further reading in that vein, see Seth Chandler’s interesting post at his blog doubting that enrollment will reach projections, and John McDonough’s cautious predictions based on experience with the Massachusetts health insurance mandate.)

Many have based their projections on the Massachusetts experience, which is an interesting comparison for several reasons, for me none more than this one: the Massachusetts mandate was relatively uncontroversial.  One survey showed 64% approval for the law in general and 52% approval for the mandate.

It goes without saying, but the PPACA has not enjoyed that kind of popular support, for a variety of reasons.  According to a recent poll, the law enjoys only 40% approval in general and only 34% approval for the individual mandate.

In theory the law is the law, so the fact that the Massachusetts mandate was more popular than is the PPACA’s individual mandate should not affect compliance.  Rather, that should be determined by the difference between the monetary penalty for non-compliance and the cost of a complying health plan.  (Under the PPACA in year one, the penalty is $95 or 1% of your taxable income, whichever is higher; under the Massachusetts law in year one, it was $219.  So the PPACA’s penalty is higher for those making more than $21,900 in taxable income.  I haven’t compared the premiums of complying plans in Massachusetts year one to the premiums of plans on the Exchanges.)

But there is research that suggests that the controversy surrounding the law could matter for compliance.   Read More

Video Now Available: Responsibility and Integrity in the Pharmaceutical Industry

The Petrie-Flom Center Staff Leave a comment

On November 21, the Petrie-Flom Center hosted 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.  (You can read a summary of the lecture here.) You can now view the lecture online.

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.

Animals in Court: Does Personhood Matter?

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In 1386, a female pig was put on trial in France for causing the death of a child by tearing his face and arms.  Trials such as this were not uncommon in medieval Europe. As E.P. Evans describes in The Criminal Prosecution and Capital Punishment of Animals, the same procedural rules applied to human and animal defendants, and the defense counsel for animals often raised complex legal arguments on their behalf.  In this case, the sow was found guilty, and under the law of “eye-for-an-eye,” the tribunal ordered that she be maimed in the head and upper limbs and hanged in the public square.

Animals today hold a very different place in our law.   As the subject of extensive legal protections and the beneficiaries of private trusts, they are no longer defendants in our courts, but rather aspiring plaintiffs.

Earlier this week, a series of habeas corpus petitions were filed on behalf of chimpanzees being held in confinement for various purposes in the state of New York.  (Court documents available here). The petitions, filed on behalf of the chimpanzees by the Nonhuman Rights Project, ask the court to recognize that the chimpanzees are legal persons with a right to bodily liberty, and to order that they be moved into the care of the North American Primate Sanctuary Alliance.  This is the first time that a habeas petition has been filed on behalf of an animal in the United States.

Of the many important and interesting issues raised by these petitions, I will in this post focus the significance of granting legal personhood to animals.

While courts in the US have not previously been asked to recognize an animal as a person with a common law right of liberty, they have been confronted with a remarkable number of cases in which animal species are listed as lead plaintiffs—most often in suits brought to enforce provisions of the Animal Welfare Act (AWA) and Endangered Species Act (ESA).  In one such case, the Ninth Circuit ruled that the endangered bird species at issue was a party with “legal status and wings its way into federal court as a plaintiff in its own right.”

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MONDAY: Conference, “Companies’ Global Health ‘Footprint’: Could Rating Help?”

The Petrie-Flom Center Staff Leave a comment

Imagine a rating or accreditation system for companies’ “global health footprint.” Such a system would rigorously assess companies’ overall impact on human health, including the health of the world’s poorest and sickest populations, then disseminate this information in ways that users could readily understand and act upon. If successful, such a system would inform and enhance choice for ethically-minded corporate executives, board members, investors, business partners, workers, consumers, and regulators.

Bringing together leaders and experts in ethics, global health, business, law, communication, and health-related quality and safety certification, this conference will discuss dilemmas, share best practices, and seek to identify forms of global health impact monitoring and labeling that could be affordable, rigorous, reliable, sensitive to community needs, and user-friendly.

The conference is free and open to the public, but registration is required. For more information, including the full conference agenda and registration links, please visit our website.

Organized by:
Nir Eyal, Associate Professor of Global Health and Social Medicine
Jennifer Miller, Edmond J. Safra Lab Fellow

Co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University; the Division of Medical Ethics at Harvard Medical School; the Harvard Global Health Institute; and the Petrie-Flom Center, with support from the Oswald DeN. Cammann Fund.

My Comments on HHS’s Proposed Rule Criminalizing Trade in Blood Stem Cells

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Professor Nalini Ambady (1959-2013)
Professor Nalini Ambady (1959-2013)

By Michelle Meyer

Bonjour de Toulouse, where I’m visiting this month at the Institute for Advanced Study (IAST), which is hosted by the Université de Toulouse Capitole and physically (and in many senses conceptually) situated inside the Toulouse School of Economics. That setting is a particularly good one for this post on markets in human tissue.

In early October, I wrote about a rule that the Department of Health and Human Services has proposed that would amend the National Organ Transplant Act (NOTA) to criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized under the statute. At the end of the post, I promised to follow up with a second post on why I’m skeptical about this rule, as a matter of policy. This is that post.

But before discussing appropriate policy for addressing the problem of the 3,000 Americans who die each year for want of a bone marrow transplant, and for reasons I’ll explain near the end of my post, I want to say something about one particular person: Professor Nalini Ambady, a Stanford social psychologist who, about one year ago, began an international search for a compatible, willing HSC donor to treat her leukemia.

Because she is South Asian, and because few Asians and other racial and ethnic minorities are listed in the U.S. bone marrow registry — South Asians comprise only 2% of the U.S. registry — she had a difficult time finding a match. She nevertheless found 12 potential matches in the U.S. bone marrow registry, and apparently at one point had scheduled the transplant. In the end, however, half were ruled out as imperfect matches — and each of the remaining six matches declined to donate.

Having exhausted the U.S. registry, Ambady and her supporters sought a match in South Asia registries — but even fewer people are registered in that region than in the U.S. Of India’s 1.2 billion people, for example, only about 45,000 are registered. Nevertheless, a potential thirteenth match was found in an Indian registry. He matched at least 6 of 10 HLA markers; he would need a blood test to determine whether he was a complete match. Unfortunately, after a worrisome week of silence about whether he was indeed a complete match, Ambady and her family learned that the potential donor had backed out.

And then a potential fourteenth match:

Weeks later, it happened with another potential match for Nalini, this time an 8/10 and so an even likelier match. This man wanted to watch someone else donate their bone marrow before making up his mind. A registry chief actually arranged this for him in early May. Somehow, it wasn’t persuasive enough. He, too, decided not to donate.

Professor Ambady died on October 28 after eight compatible or potentially compatible registered donors ultimately declined to donate.

Apparently, declining to donate after agreeing to be listed in a registry and being found to be a match is quite common. According to one registry chief, the attrition rate is 50% in the U.S., Europe, and India. Would a financial incentive have tipped any of these vaccillating prospective donors towards a decision to donate? Although we can’t say, this is an eminently answerable question. Unfortunately, the Department seems uninterested in learning whether a compensation scheme would save lives — or have ill or counterproductive effects — or not.

In its Notice, the Department lists the following policy reasons for expanding NOTA’s list of “organs,” the exchange of which for valuable consideration is prohibited, to include PBSCs: (1) preventing commodification; (2) curbing opportunities for coercion of PBSC providers and (3) exploitation of PBSC recipients; (4) encouraging altruistic donations, and (5) decreasing the likelihood of disease transmission resulting from paid donations. My responses to these arguments are after the jump. I end with some thoughts about alternative policy tools for increasing the supply of PBSCs in the absence of a legal compensation scheme.

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Challenges to Third-Party Food Safety Audits and Certification

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By Ching-Fu Lin

About a month ago, Jensen Farms pleaded guilty to federal criminal charges for introducing adulterated food into the nation’s food supply via interstate commerce.  In 2011, cantaloupes produced by Jensen Farms resulted in a listeria outbreak that spread across 28 states, killed 33 people, and sickened hundreds.  The now bankrupt and out of business owners—brothers Eric and Ryan Jensen—are to be sentenced in January 2014.

The Jensens took responsibility for one of the deadliest food safety outbreaks in the United States, but they also turned around to sue Primus Labs, a food safety audit firm.  The brothers allege that Primus Labs acted negligently, breached its contractual obligations, and engaged in deceptive trade practices in performing third-party audits on the farmlands and packing house.  Merely weeks before the outbreak, Primus Labs sent one of its subcontractors (Bio Food Safety) to Jensen Farms to perform a third-party audit.  After the audit, Bio Food Safety gave Jensen Farms a “superior” rating with an almost impeccable score of 96 out of 100, which was later found by the Food and Drug Administration (FDA) to be “seriously deficient in its inspection and findings.”  As claimed by the Jensens, Bio Food Safety failed to observe several practices that were in violation of Primus Labs’ standards and relevant FDA guidelines or to inform them of any microbiological risk.  Despite these deficiencies, Jensen Farms cantaloupes were “Primus Certified” and entered into the retail market.

The Jensen Farms case raises questions on the credibility of third-party audits and certifications in the area of food safety.

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Art Caplan: When Religion Trumps Medicine

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By Art Caplan

Cross-post from bioethics.net

Imagine that you were in a terrible car accident and suffered a huge loss of blood. An ambulance comes and takes you, dazed and in pain, to the only hospital within a hundred mile area of the accident. That hospital happens to be affiliated with the Jehovah’s Witnesses. Everything at the hospital is state of the art. The doctors and nurses are all well trained. There is only one hitch in terms of your medical care. You need blood transfusions or you are going to die. The hospital does not have a blood bank. Nor does it offer transfusions. They believe blood transfusion violates their faith. The doctor suggests you be given a lot of fluids to maintain your ‘volume’ and that you hope for the best. Wouldn’t you demand that the Witness affiliated hospital put aside their faith-based beliefs and do what is medically indicated and either provide a transfusion or try to arrange one? If you did not recover would you expect your family to accept the fact that your death could easily have been prevented but for the hospital’s decision to put theology over medicine?

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