Worth Reading This Week

By Nicolas Terry

Cross-posted at HealthLawProfs

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

By Dan Vorhaus (Cross-Posted from Genomics Law Report)

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”  The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:

Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.

In certain respects, this article is an expansion of a previous piece three of us wrote on the Genomics Law Report last year discussing Myriad Genetics’ response to the rise of whole-genome sequencing technologies in the context of diagnostic genetic testing. The current EJHG expands upon that discussion, while still using Myriad Genetics as a case study, particularly the company’s development of a proprietary database of DNA sequence variants (including variants of uncertain significance, or VUSs) and related clinical information pertaining to the breast cancer genes BRCA-1 and BRCA-2.

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DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing

By Dan Vorhaus (Cross-Posted from Genomics Law Report)

This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut of a new division, DNA DTC. (Apparently the news was also announced earlier this month at the Family Tree DNA Conference, although the company waited until today to launch press releases.)

The announcement from Gene By Gene is newsworthy for several reasons, including:

1. The Return of True DTC Whole Genome and Whole Exome Sequencing. According to DNA DTC, the company offers a range of products “utilizing next generation sequencing including the entire exome (at 80x coverage) and the whole genome.” The company’s website, while fairly Spartan, appears to bear this out. Whole exomes ($695 at 80x coverage) and genomes ($5,495 at 30x coverage) are both listed as available products.

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Meaningful Scrutiny for Meaningful Use

By Nicolas Terry

Today the Office of the Inspector General (OIG) in the Department of Health and Human Services released a report, here, that is decidedly critical of CMS and ONC oversight of the Electronic Health Record (EHR) subsidy program.

Over the last couple of years there have been growing criticisms of the Meaningful Use program and its disbursement of potentially $30 billion in ARRA funds. I have detailed many of these concerns, such as the overall effectiveness of electronic records, my doubts as to the robustness of the first two Stages of Meaningful Use requirements, the safety record of the technologies, their ability to actually save money, their real-world interoperability, and their general usability in the healthcare workflow, here.

Recently, additional questions have been raised that go to the very heart of the subsidy program. First, the Center for Public Integrity, here,  and the New York Times, here, set off a firestorm with allegations of EHR use leading to extensive upcoding. This led to a scolding letter to the healthcare industry from Secretary Sebelius and the Attorney-General, here, and combative words back from some of the addressees, here.

Questions have also been raised about the apparent laxity of CMS in approving payment to providers claiming subsidy funds, leading to CMS announcing a hastily designed audit process, here.

Today’s OIG report elaborates on the same basic issue of lax payment safeguards. First, the report finds that CMS has not implemented strong pre-payment safeguards (either by verifying self-reported data or requiring supporting documentation). Second, it suggests that CMS’s proposed post-payment audit program is limited and potentially flawed. Fortunately, CMS/ONC are in broad agreement with the OIG that the EHR technology itself must step up and meaningfully test for meaningful use. In the meantime increased Congressional scrutiny seems a less elegant but likely surrogate.

Does Your Hospital Make You Sicker?

New hospital safety scores were released this week, and around the country, those that scored well are crowing (see e.g., here and here).  The data is provided by a nonprofit called Leapfrog Group, which compiles survey-responses  and CMS data on a website called hospitalsafetyscore.org.  Check out your own hospitals.  The Leapfrog Group includes several leaders in the hospital safety movement, including Peter Pronovost (of checklist fame) and Lucian Leape (author of the seminal 1994 JAMA article on the topic).  Is anyone aware of an empirical study that looks at the relationship between these scores and medical malpractice liability claims or payouts?  Any attorneys that use this sort of data in the litigation of individual cases?

Homeland Security Internship Opportunity

The U.S. Department of Homeland Security (DHS) sponsors a 10-week summer internship program for students majoring in homeland security related science, technology, engineering and mathematics (HS-STEM) disciplines. This program is open to undergraduate students in a broad spectrum of DHS mission-relevant research areas and graduate students interested in the specific field of Nuclear and Radiological Threat Detection.

The DHS HS-STEM Summer Internship Program provides students with the opportunity to conduct research at federal research facilities located across the country. The goal of this program is to engage a diverse, educated, and skilled pool of scientists and engineers in HS-STEM issues and to promote long-term relationships between student researchers, DHS, and federal research facilities to enhance the HS-STEM workforce.

DHS has partnered with the Oak Ridge Institute for Science and Education (ORISE) to manage the application and review process, notification, and implementation of the program.

For more information, click here.

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You Have to Read This

By Scott Burris

Australian public health law savant Chris Reynolds recently stopped by Temple Law School to discuss the South Australia Public Health Act of 2011.  It is a fresh look at how to write a basic public health law statute, but one provision took my breath away.

62—Minister may issue code of practice

(1) The Minister may issue a code of practice in relation to preventing or reducing the incidence of a non-communicable condition.

(2) A code of practice may relate to—

(a) an industry or sector;
(b) a section or part of the community;
(c) an activity, undertaking or circumstance.

(3) Without limiting subsection (1) or (2), a code of practice may relate to the manner in which, for the purposes of public health—

(a) specified goods, substances or services are advertised, sponsored, promoted or marketed (including through the provision of certain information to consumers of certain goods, substances, or services);
(b) specified goods or substances are manufactured, distributed, supplied or sold (including the composition, contents, additives and design of specified goods or substances);
(c) buildings, infrastructure or other works are designed, constructed or maintained;
(d) the public, or certain sections of the public, are able to access specified goods, substances or services.

(4) The Minister must, before issuing or amending a code of practice, insofar as is reasonably practicable, consult with any person or organisation that the Minister considers to be representative of any industry or sector affected by the proposed code or amendment.

(5) The Minister may publish a report on the performance of an industry, sector or person in relation to a code.

(6) The Minister must, before publishing a report under subsection (5) that would reasonably be expected to have an adverse impact on a person specifically identified in the report, provide a copy of the report to the person and then allow the person at least 14 days to make written representations in relation to the contents of the report.

(7) No action lies against the Minister in respect of the contents of a report published under this section.

A code of practice is enforceable under a “general duty clause” that stipulates that  “a person must take all reasonable steps to prevent or minimise any harm to public health caused by, or likely to be caused by, anything done or omitted to be done by the person.”

Here’s a law, passed by actual legislators, that gives a health minister sweeping powers to directly, comprehensively, creatively and flexibly regulate products and activities that create both risks and benefits to the public.

We’ll wait with baited breath to see whether it works or not, but it’s already got me wondering whether they have any decent industry lobbyists in Australia.

TODAY – Nourishing a Legal Career in the Life Sciences

TODAY

3:00-4:00pm (reception to follow)

Milstein Conference Rooms, Wasserstein Building, Harvard Law School

Nourishing a Legal Career in the Life Sciences

Please join us for a career discussion with Amy Schulman, Lecturer on Law at HLS, Executive Vice President and General Counsel at Pfizer, Inc., President and General Manager of Pfizer Nutrition, and Mark Nance, Senior Vice President and General Counsel at Mylan, Inc. The discussion will be moderated by Professor David Wilkins.

Co-sponsored by the Program on the Legal Profession, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the HLS Office of Career Services.

Tobacco Companies Must Punch Selves in Face, Court Orders

The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive.  I have pulled the district court order and posted it here, along with this appendix.  The order provides the exact language of the mandated advertisements, but no analysis.  Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.

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TODAY: Stem Cell Therapy and Medical Tourism

TODAY, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

WaPo on Industry Influence of Clinical Trials

The Washington Post has an extensive story about the drug and device industry’s influence on the outcomes of clinical trials, which are published in leading medical journals and which then shape the prescribing decisions of physicians everywhere.  Below the fold, I share some of my own thinking on this issue, and link to some of my relevant publications.   Continue reading

The Readmission Penalty Begins to Bite

By Nicolas Terry

As is well known ACA § 3025 (§1886(q) Social Security Act) established the Hospital Readmissions Reduction program. This is operationalized through deductions built into the Hospital IPPS (Inpatient Prospective Payment Systems) Rule which sets the Medicare reimbursement amounts, here. The excess readmissions ratio initially only applies to readmissions based on MI, Heart Failure, and Pneumonia. Initially the maximum deduction is 1% but that rises to 2% in October 2013 and 3% in October 2015.

A parallel program for Medicaid designed to reduce hospital-acquired infections was introduced in the 2005 Deficit Reduction Act, here. However, Lee and colleagues, here, found no change in infection rates. Nevertheless, the dollars associated with readmissions reduction may give that program greater traction.

Jordan Rau in the New York Times, here, notes that 307 hospitals are already facing the maximum reduction involving many millions of dollars. Not surprisingly some hospitals view the penalties as a distraction while others blame their patients for everything from their level of sickness and poverty to non-compliance. Overall, however, Rau’s article and Amy Boutwell’s recent post at Health Affairs, here, suggest that CMS is succeeding in getting the industry’s attention.

The Ethics of Bike Shares: Some Tough Distributive Justice Questions about Helmets, Fatalities, and Obesity/Heart Disease

Boston recently followed many other world cities in implementing a bike share program. As the New York Times recently reported, North American cities face a dilemma: if the European experience is any guide, for bike shares to take off the city must do away with the helmet requirement. That turns out to be not a health versus leisure trade-off, but a complex health vs. health trade-off. As the New York Times puts it:

In the United States the notion that bike helmets promote health and safety by preventing head injuries is taken as pretty near God’s truth. Un-helmeted cyclists are regarded as irresponsible, like people who smoke. Cities are aggressive in helmet promotion. But many European health experts have taken a very different view: Yes, there are studies that show that if you fall off a bicycle at a certain speed and hit your head, a helmet can reduce your risk of serious head injury. But such falls off bikes are rare — exceedingly so in mature urban cycling systems. On the other hand, many researchers say, if you force or pressure people to wear helmets, you discourage them from riding bicycles. That means more obesity, heart disease and diabetes. And — Catch-22 — a result is fewer ordinary cyclists on the road, which makes it harder to develop a safe bicycling network.

Suppose hypothetically we came to the conclusion that more life years would be lost to obesity/heart disease related injuries from forbidding helmet laws than would be saved from putting helmets in place, would that justify doing away with our helmet laws? Does it matter that the injuries cause immediate death/injury in the un-helmeted case but are gradual to accumulate as to obesity and heart disease in the helmet case? That might in turn depend on whether we believe in the “rule of rescue” and whether we think of it as merely a rule about allocating aid versus preventing harm in the first place. If most bicyclists who are injured are younger, given the typical profile of the city biker, is there a dimension of age-weighting that might be relevant. Or, in fact, given that those who do not use bikes now due to the helmet laws will be older when they suffer from obesity/heart disease give us a reason to think age-weighting is inappropriate in this domain. This is somewhat similar to the arguments offered in the Age Discrimination in Employment Act (ADEA) context, that unlike Title VII or the ADA we will ALL (if things go well) eventually be old, so protection for the old benefits everyone. However, those who get hit by cars without helmets will likely die young. Finally, what role for choice, responsibility, resistance to the nanny state, etc?

Twitter Round-Up (11/18-11/24)

By Casey Thomson

After what we hope was a hearty meal (or at least a restful, happy holiday) this past Thanksgiving for all of our readers, we are back with this week’s Twitter round-up – just a few days behind schedule.

  • Daniel Goldberg (@prof_goldberg) tweeted an article by Stefan Fatsis on the different perspectives regarding child participation in tackle football. As Goldberg noted in his tweet, from the perspective of neuroethics, the choice is clear: tackle football (or American football) is harmful for kids. (11/19)
  • Frank Pasquale (@FrankPasquale) included a link to a piece describing why data from all clinical trials should be readily accessible to doctors, or the origins of the BMJ Open Data Campaign. The article used the case of the Tamiflu anti-flu drug as an example, where the article authors described their hurdles in communicating with the drug’s producers concerning drug test results while trying to review the efficacy of the drug through Cochrane Collaboration. (11/21)
  • Kevin Outterson (@koutterson) posted his article, published in the New England Journal of Medicine, concerning the path for new federal regulations for compounding pharmacies in the wake of the meningitis outbreak and the New England Compounding Center (NECC). (11/23)
  • Arthur Caplan (@ArthurCaplan) brought up a recent post concerning the American College of Obstetricians and Gynecologists (ACOG) and their declaration that making birth control pills over-the-counter (OTC), rather than prescription, could reduce the rate of unplanned pregnancies in the United States (which has not changed in 20 years). While the change would not occur overnight, there are many consequences that remain unclear – including changes in price and insurance coverage. (11/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link to David Shaywitz’s article, which noted the increased criticism and distrust facing industry studies as compared to those of university scientists. Shaywitz encouraged contextualization of industry criticism to recognize that such critiques often plague medical science in general, not just industry. (11/24)

Note: As a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.

The New Diagnostic Scan for Alzheimer’s Disease

[Ed. Note: We're happy to announce that after a great month of guest blogging, Chris Robertson will be joining Bill of Health as a regular contributor.]

The New York Times brings us an interesting story about a new brain scan technology that allows the diagnosis of Alzheimer’s Disease.  Below the fold, I sketch a few interesting themes for health law, including the FDA’s authority over the practice of medicine, the use of blinding to improve clinical decision making, the value of a clinical diagnosis for an untreatable condition, and the problems of pre-existing conditions clauses in long-term care insurance. Continue reading

EPA Seeks Comments on Monsanto’s Request for Experimental Use of Genetically-Modified BT Corn

Efthimios Parasidis

The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.”  As a result, the agency is seeking public comment on Monsanto’s application.

Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years.  The corn is bioengineered to produce Bacillus thuringiensis (BT)a bacteria that is known to kill rootworm.  The risks of BT-engineered crops are not fully known.  In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.

To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides.  However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin.  In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses.  Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.

Variability in Local IRB Regulation: A Gold Mine for Future Research

When I moved to the University of Arizona, I quickly discovered something that I’ll politely call “heterogeneity” in Institutional Review Board’s (IRB) policies and practices.  All of a sudden, some of the rather vanilla human subjects research practices I had been doing for years, with IRB approval, were now forbidden.  Turns out that I had been exerting “undue influence” on human subjects all along by — wait for it — telling them how much I proposed to pay them.  (Good thing there is no IRB jail for miscreants like me.)

I’ve since learned that there is a scholarly literature about the tendencies of IRBs to vary in how they decide the same cases.  For example, Green and colleagues (2006) described their experience getting IRB approval for an observational study in 43 Department of Veterans Affairs medical centers.  They explain:

The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA … consent from physicians although no health information was asked of them. … Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.  Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions.

How can such disparate results come out of IRBs all applying the same Federal common rule?  And is that sort of variability justified by the 4,680 hours of staff time that Green reports spending navigating through this regulatory maze?  As I explain below the fold, this incident is not isolated.

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Are You My Mother? (Guest Post for Kimberly Mutcherson)

[Editorial Note: This Post is by Kimberly Mutcherson]

Some states have come to terms with commercial surrogacy and create standards to protect parties to contracts and the children born of those contracts. New Jersey, however, just can’t seem to get it right when it comes to surrogacy arrangements. I suppose that is no surprise coming from the state that brought us one of the nation’s most notorious surrogacy related custody disputes—the 1988 Baby M. case. Over 20 years after Baby M., our state courts continue to run scared from the reality of 3rd party reproduction.  The latest blow to sensible policy related to surrogacy comes from an October 2012 New Jersey Supreme Court decision in a case called, In Re: The Parentage of a Child by T.J.S. and A.L.S. The facts are fairly simple within the world of assisted reproduction. A married man and woman hired a gestational surrogate to carry an embryo formed from the husband’s sperm and an egg purchased from an anonymous source. The only two people in this arrangement who were interested in being parents to the child born of this pregnancy were the husband and wife.

To protect their interests and those of the gestational surrogate who, after all, was not looking to add another child to her household, the intended parents sought a pre-birth order from family court. That order was a declaration of parentage, which would have allowed the names of the intended parents to appear on the child’s birth certificate after the gestational carrier voluntarily relinquished her rights to the child. By statute, the relinquishment of parental rights could not take place until 72-hours after the child’s birth. As was contemplated by the agreement between the parties, three days after the child’s birth, the surrogate relinquished her rights after which the pre-birth order required the release of a birth certificate with the names of the intended parents. Here is where things got loopy. The State Registrar got wind of the pre-birth order and moved to vacate the portion of the order as to the issuance of the birth certificate. New Jersey, thus, took the position that the intended mother in a gestational surrogacy arrangement who has no genetic tie to a child cannot be listed on the child’s birth certificate and must complete an adoption procedure in order to secure a legal relationship with the child.

In contrast to this set of circumstance, the New Jersey Parentage Act allows a man to be the legal father of child, without an adoption, where he consents to his wife being artificially inseminated with another man’s sperm. If you are a father with no genetic connection to a child and your wife carries the baby, you are the father and she is the mother. If you are a wife with no genetic connection to a child and a gestational surrogate carries the child, you are a legal stranger to that child unless and until you complete an adoption procedure.The intended parents argued in the Appellate Division that this distinction violated equal protection. The court disagreed and an equally divided Supreme Court upheld this decision when it could not find a majority on either side of the issue.

What we are left with in New Jersey is a system that is failing families.

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Worth Reading This Week

By Nicolas Terry

Cross-posted at HealthLawProfs