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?

By Christopher Robertson

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  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


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

By Christopher Robertson

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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