GINA in Action: Woman alleges genetic test led to firing
In what appears to be the first publicly identified case of its kind, a Connecticut woman has accused her employer of violating the recently enacted federal Genetic Information Nondiscrimination Act (GINA). According to a story in the Boston Herald (discovered thanks to a tip from Matt Mealiffe), 39-year-old Pamela Fink received an elective double mastectomy last year after testing positive for mutations in her BRCA2 gene associated with an increased risk of breast cancer. Fink alleges that, despite giving her “glowing evaluations for years,” her employer, MXenergy, “targeted, demoted and eventually dismissed her when she told them of the genetic test results.”
GINA, which was passed by Congress in 2008 and took effect last year, represents the most comprehensive effort to date to regulate the use of genetic information by employers (Title II) and health care insurers (Title I). Under Section 201(a)(i) of GINA, employers with more than 15 employees may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment…because of genetic information.”
The Unexpected Impact of Genetics on the Business World
Recent advances in genetic science are remarkable. In 2003 the first full human genome was sequenced after 13 years of work at a cost of over $3 billion. Today, the cost to sequence any individual’s entire genome is approaching $1,000. Genetic tests for specific genes linked to cancer and other diseases exist today and many more are being developed. We hear of a new era of “personalized medicine” in which drugs and therapies will be prescribed based on the individual patient’s specific genes.
All of this may seem to have little direct relevance to companies outside of biotechnology. However, the development of genetic knowledge and technology already has spawned new laws, regulations and patent uncertainties that impact almost all businesses in some way.
Privacy and Nondiscrimination. The federal Genetic Information Nondiscrimination Act of 2008 (GINA) represents the most comprehensive effort to date to regulate the use of genetic information. GINA initially only prohibited health insurers and group health plans from using genetic information to deny coverage or set payment rates. Another section, which just became effective in November 2009, affects all private and public employers with more than 15 employees.
What ELSI was New? Plenty.
From October 5 to December 8, 2009, the Genomics Law Report featured a series of thirty-six guest commentaries by industry, academic and thought leaders in the fields of genomics and personalized medicine. Entitled What ELSI is New?, the series, which we have organized into an e-book (pdf), asked each contributor to briefly respond to the following question: “What do you believe is the most important ethical, legal or social issue (ELSI) that must be addressed by the fields of genomics and/or personalized medicine?”
For better or worse, that’s where the instructions ended. The invited contributors identified the ELSI of their choice and discussed (or not) their rationale for so selecting as they saw fit. In addition to refraining from substantive editing, we intentionally avoided coordinating commentaries. Although we encouraged independent submissions from a variety of contributors and deprived them of any advance knowledge of what others in the series would say, one of our hopes was that consensus would begin to form around certain key ethical, legal and social issues.
To some degree this occurred. In collecting the series for the convenience of readers who would like to have all of the contributions in one place (pdf), we have ultimately settled on six broad topic headings for the commentaries
Read the rest of this entry »
GINA: Coming Soon to a Workplace Poster Near You
As we reminded you last week, Title II of the Genetic Information Nondiscrimination Act (GINA) took effect on November 21st. Title II prohibits genetic discrimination and restricts the collection of genetic information by all private, state, and local government employers with more than fifteen employees. (Title I prohibits health insurers and group plans from using genetic information to deny coverage or set payment rates.)
For all the attention that GINA has achieved, many Americans will soon learn of its existence for the first time in break rooms and at water coolers across the country, courtesy of the Equal Employment Opportunity Commission’s (EEOC) new workplace poster (pdf). The poster is required to be displayed by all employers covered by federal anti-discrimination laws.
Welcoming GINA into the Workplace
The most recent layer of federal antidiscrimination law took effect this past weekend – to the ADA, Title VII, FMLA and other federal and state laws, employers can add another: the Genetic Information Nondiscrimination Act. Title I of this new law (called GINA) took effect in May 2009, prohibiting health insurers and group plans from using genetic information to deny coverage or set payment rates. Title II now joins the fray, and with it brings prohibitions that make their way into almost every workplace. Under Title II, an employer may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment … because of genetic information.”
While a long time in the making (13 years of (often procedural) debate), in the end, there was little argument in Congress that this law was needed – the Senate approved it unanimously, and the House of Representatives had only one vote against it. As early as January 2001, the Council for Responsible Genetics claimed hundreds of documented cases of genetic discrimination and/or fear of genetic discrimination in its Genetic Discrimination: Position Paper (pdf). In a 2007 survey (pdf), the Genetics and Public Policy Center found that 92% of participants expressed concerns that a genetic test could be used in harmful ways against a person. Last summer, we reported on Major League Baseball’s genetic testing to verify the reported ages of certain Latin American prospects. This past month, the University of Akron made headlines over a new policy requiring job applicants to turn over DNA samples, and in the process energized the Ohio chapter of the ACLU.
The Human Provenance Project Attempts to Unring the Bell
Last week I wrote about the U.K. Border Agency’s widely criticized Human Provenance pilot project (“Why the Errors of the Human Provenance Project Will Echo Beyond the U.K.’s Borders”) and suggested that “we should not be surprised to see the pilot project substantially revised, or even scrapped altogether.” I worried, though, that the damage may already have been done by contributing to a highly charged atmosphere that could add to pressure for premature regulation and public skepticism.
Today brings word, via ScienceInsider, that the Border Agency is pulling back on its plans to use DNA and isotope analysis to evaluate the nationality of asylum seekers attempting to enter the U.K. According to ScienceInsider:
In a statement released this afternoon by the Home Office, which oversees the Border Agency, the department’s Chief Scientific Advisor Paul Wiles now says such evidence will be collected for later analysis of its potential but will not currently be used for individual case decisions.
As Daniel MacArthur points out at Genetic Future, while some of the initial outrage over the Border Agency’s policy may have been overstated, “the initial policy was still grossly premature” and the “Border Agency’s decision to take a step back and consider the implications before wading into the morass of genetic ancestry testing” is a welcome development.
Why the Errors of the Human Provenance Project Will Echo Beyond the U.K.’s Borders
ScienceInsider has posted several pieces this morning describing and critiquing the U.K. Border Agency’s Human Provenance pilot project:
Scientists are greeting with surprise and dismay a project to use DNA and isotope analysis of tissue from asylum seekers to evaluate their nationality and help decide who can enter the United Kingdom. “Horrifying,” “naïve,” and “flawed” are among the adjectives geneticists and isotope specialists have used to describe the “Human Provenance pilot project,” launched quietly in mid-September by the U.K. Border Agency. Their consensus: The project is not scientifically valid—or even sensible.
In addition to the feature article, ScienceInsider has also published a FAQ describing what is now known about the program as well as links to the underlying documents and expanded reactions from leading geneticists and isotope specialists.
The project is, as the name indicates, a pilot project, and one spokesperson described it as being “in its baby stages.” Still, as reported by ScienceInsider, the scientific community’s reaction to the program appears to be swift, unanimous and extraordinarily critical. Daniel MacArthur of Genetic Future has a slightly more measured take, expressing skepticism about the ability of the government agency to identify precisely an individual’s geographic ancestry based on genomic data and rightly pointing out that the “crucial issue is that it must be shown that the data are used in appropriate ways, and not given undue weight in making serious decisions about a person’s future.” That’s an issue that cannot be resolved until the Border Agency provides additional details on both its scientific methods and its utilization of the collected DNA and isotope data.
The near-uniform scientific skepticism that has greeted the announcement of the Human Provenance project suggests that we should not be surprised to see the pilot project substantially revised, or even scrapped altogether. But has damage already been done?
Genetic Exceptionalism and Paternalism Themes in new German Legislation
In April, the German Parliament approved the Human Genetic Examination Act. An English translation of the Act (pdf), which appears likely to be enacted, was recently posted to EuroGentest. (Special thanks to the PHG Foundation for locating the translation.) The Act is a clear example of what is known as “genetic exceptionalism”—the belief that genetic information is qualitatively different from other forms of personal or medical information—staking out a position near the paternalistic end of genetic regulation. Despite aspiring “to protect human dignity and ensure the individual right to self-determination via sufficient information,” the substance of the Act severely restricts individual freedom of action.
Strict Regulation of Genetic Examinations
The Act employs the terms “genetic examination” and “genetic analysis” in most of its provisions and defines these terms so broadly (§ 3) as to admit some uncertainty as to what would or would not constitute a genetic examination or genetic analysis. The vagueness of the definitions is mitigated to a degree by other defined terms that clarify that the Act’s provisions on genetic examinations and genetic analyses apply, in fact, to such examinations and analyses for medical purposes or for determining descent. The Act requires that “diagnostic” or “predictive” genetic examinations be ordered and interpreted by medical doctors having appropriate training and conducted only by institutions having the appropriate accreditation (§ 7). Such genetic examinations and genetic analyses may be conducted only upon the express, written and informed consent of the patient (§ 8).
MLB’s Genetic Testing Program at the Plate Again
The New York Times published a follow up piece to its story on Major League Baseball using genetic testing to confirm the reported ages of some young baseball aspirants. Last week’s GLR post examined MLB’s genetic testing program in the context of the Genetic Information Nondiscrimination Act (GINA) and has prompted further internal discussion here at GLR, with our own John Conley asking a few questions:
I guess MLB would say they’re not using genetic information to discriminate in the usual sense of screening out high-risk people, but just to verify that the prospect isn’t defrauding them about an essential datum — after some notorious cases of lying and producing false documents in both directions. And in the Bulls’ defense, they said they were spooked by numerous cases of basketball players dropping dead as a result of undiagnosed heart defects that seem to afflict the very tall. I guess they were also mindful of Reggie Lewis of the Celtics, who passed out, WAS diagnosed, shopped for a favorable opinion, then died playing. Does GINA allow any sort of defensive testing like this by employees whose work creates risk to particular categories of people? Or must the employer let the employees kill themselves if they wish?
There is clearly a good practical reason for the testing in both cases that John identifies, but neither testing to confirm identity (or otherwise prevent fraud, as in the case of MLB) or to prevent even potentially fatal medical conditions (as in the case of Eddy Curry) is explicitly permitted under GINA. In the case of MLB, the result will depend, in part, on how the EEOC interprets the following pair of GINA’s definitions (from Section 201 of GINA). Again, the interpretive issue is whether “genetic information”, which may not be used for making employment decisions, covers the kind of testing in the MLB matter.
MLB Meets GINA
According to an article in today’s New York Times, Major League Baseball’s department of investigations is conducting genetic testing on certain Latin American prospects in an attempt to verify their reported ages. The Times reports that MLB has confirmed that it conducts genetic testing to confirm paternity/maternity “in very rare instances and only on a consensual basis to deal with the identity fraud problem that the league faces in [the Dominican Republic].” It appears that MLB is using paternity/maternity testing to verify identity by confirming that a particular prospect is in fact the child of the parents claimed on his birth certificate. MLB’s program appears to be the first publicly disclosed genetic testing program since the passage of the Genetic Information Nondiscrimination Act, or GINA as it is known, fourteen months ago.
This is not the first time that genetic testing in professional sports has made its way into the headlines. In 2005, the Chicago Bulls demanded that center Eddy Curry submit to a genetic test for Hypertrophic Cardiomyopathy (HCM). Despite playing in 72 games the prior season, Curry was diagnosed with an irregular heartbeat and an enlarged heart and the team insisted on the HCM test as a condition to extending his contract. Curry refused to take the genetic test and was ultimately traded to the New York Knicks, temporarily defusing the situation.
Read the rest of this entry »
