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As House Reconsiders Genetic Discrimination Act, Envoys Stress Public's Privacy Concerns

As President George W. Bush urged Congress last week to pass the stalled Genetic Information Nondiscrimination Act, advocates of pharmacogenomic research took the opportunity to stress that the public’s concern over genetic discrimination remains one of the major barriers to personalized medicine.  
The bipartisan bill, H.R. 493, was reintroduced in the US House of Representatives by Rules Committee Chair Louise Slaughter, a Democrat from New York, and Judy Biggert, a Republican from Illinois, with the support of more than 150 representatives. The bill was also reintroduced in the US Senate to be marked up this week.
The president last week encouraged Congress to pass the bill, which would make it illegal for insurance companies to make coverage decisions and for employers to make hiring or firing choices based on people’s genetic predisposition for certain diseases.
“Unwarranted use of genetic information, and the fear of potential discrimination, threatens both society’s ability to use new genetic technologies to improve human health and the ability to conduct the research needed to understand, treat, and prevent diseases,” the administration said. “Enactment of federal legislation will help guarantee that the nation fully realizes the potential of ongoing advances in genetic sciences.”
Slaughter first introduced the legislation, known as GINA, more than a decade ago. The Senate has twice unanimously passed the legislation when it was introduced in 2003 and 2005 by Sen. Olympia Snowe, a Republican from Maine. However, the bill remains stalled in the House, where it has never come to a vote due to political opposition.
“In the 12 years since I first introduced GINA, the need for this legislation has grown exponentially,” Slaughter said in a statement this week. “Scientific research has advanced so quickly that we cannot afford to wait any longer. This bill will allow us to preserve America’s health and protect our scientific edge, all the while defending the privacy of our citizens.”
Supporters of the bill are optimistic that it has a greater chance of being approved in the new Democratically controlled Congress. Meanwhile, the message from lobbyists and interest groups has taken on a pharmacogenomics angle that emphasizes the need for genetic nondiscrimination laws in an era of gene-based therapies and diagnostics.
GINA’s Improved Chances In Congress
GINA would restrict health insurers from denying coverage or charging higher premiums based on an individual’s predisposition to a genetic condition. Similarly, the bill would make it illegal for employers to discriminate on the basis of predictive genetic information.
Additionally, the bill would bar employers and insurers from requiring applicants to take genetic tests; require strict use and disclosure requirements of genetic test information; and enforce penalties against violators.
According to Genetic Alliance CEO Sharon Terry, the legislation has been held up in the House for so many years because the former chairmen of the three committees with jurisdiction over the bill — Ways and Means, Education and Labor, and Energy and Commerce — would not let it come to a vote.
“Over the years, the Republican chairmen of these committees wouldn’t allow for the bill to be brought to vote because their constituents in the US Chamber of Commerce and the National Association of Manufacturers didn’t want the bill to be passed,” Terry told Pharmacogenomics Reporter this week.
These constituents maintained that if passed, GINA would “make record keeping for employers more difficult and lead to frivolous lawsuits,” Terry said.
For example, on its website, the US Chamber of Commerce said that “if science progresses to the point where it is possible to determine that an individual is virtually certain to have a health condition posing significant risk to others, then employers should be able to make employment decisions based on this information.”
But with a Democratically controlled Congress all three House committees in charge of GINA are now led by Democrats: Rep. Charles Rangel from New York is now chairman of the Ways and Means Committee; Rep. George Miller from California took over the leadership of the Education and Labor Committee; and the Energy and Commerce Committee saw its leadership change to Rep. John Dingell from Michigan.
In the previous Congress, in which Democrats controlled 46.4 percent of the seats, GINA won support from 244 representatives, half of whom were Republican. In the current Congress where Democrats control 53.6 percent of the seats, the reintroduced bill has again gotten the backing of 122 Republicans, forecasting a friendlier environment for the bill, Terry said.
GINA and Personalized Medicine
GINA’s advocates are increasingly framing the bill around the promise of personalized medicine. “We will never unlock the great promise of the Human Genome Project if Americans are too paranoid to get genetic testing,” Biggert, a Republican sponsor of the legislation from the previous Congress, said in a statement. “Without the protections by H.R. 493, these fears will persist, research at NIH will slow, and Americans will never realize the benefits of gene-based medicines.”
According to Susannah Baruch, director of reproductive genetics at Johns Hopkins University’s Genetics and Public Policy Center, this strategy is not necessarily new. In the 12 years that the bill has been stalled, genomics research has advanced, making the bill’s passage an even greater necessity, she said.
“Since the bill has passed, personalized medicine has advanced,” Baruch said. “The argument developed as genomics has developed.”
One signal that the public may have concerns about genetic discrimination is a documented drop in enrollments for clinical trials of targeted therapies. Personalized Medicine Coalition Executive Director Edward Abrahams told Pharmacogenomics Reporter last week that “people drop out of clinical trials when they begin to understand that genetic information that they were willing to share [in clinical trials] cannot be protected.”
“Without genetically based clinical trials, progress [into personalized medicines] will obviously slow,” he added.
A 2003 NIH study published in the Archives of Internal Medicine titled “Genetic Counseling and Testing in Families With Hereditary Nonpolyposis Colorectal Cancer” found that 51 percent of 111 eligible first-degree relatives of people with the disease chose to undergo genetic testing.

“Without the protections by [the bill], these fears will persist, research at NIH will slow, and Americans will never realize the benefits of gene-based medicines.”

The greatest concern in 39 percent of study participants included worries of losing health insurance, leading the study authors to conclude that “fears of discrimination … may present barriers to the use of current cancer prevention strategies, including genetic counseling and testing.”
Some groups recognize theses concerns and have put in place protocols that overcome them. Pharmacy benefits manager Medco, for instance, has privacy rules in place that it hopes will help allay fears about genetic discrimination for patients participating in its pharmacogenomic studies, according to an official.
Medco, the second largest pharmacy benefits manager in the US with 60 million beneficiaries, is compliant with all patient privacy rules and regulations,” Medco Chief Medical Officer Robert Epstein said. “Per the patient consent form, the only people who will have access to the genetic information collected during our study is the patient and their physician. Employers will not have access to the information. 
“With this protocol in place we do not believe that privacy will be a barrier to participation,” Epstein said.
Drug regulators in the US, Europe, and Japan have also recognized the need to develop internationally consistent standards for privacy in data collection in pharmacogenomics studies. A draft guidance on pharmacogenomic terminology recently released by the International Conference on Harmonization describes genomic data sample categories based on the level of privacy provided to study participants (see related story).
Growing Public Support for GINA
Polls suggest that public support is growing for laws that protect genetic privacy. In a 2002 poll by the Johns Hopkins University’s Genetics and Public Policy Center, 85 percent said that if they had a genetic test their employers should not have access to the results.
From 2002 to 2004, the proportion of people who believe that genetic information should be kept private from health insurers increased from 68 percent to 80 percent.
And last year, a poll conducted by the health research advocacy group Research!America found that 76 percent of Americans think Congress should protect people’s genetic information.
In sponsoring the bill, Slaughter cited several high-profile instances of genetic discrimination indicating the need for legislation in this area. The examples included denying African Americans employment, education, and insurance in the 1970s based on their carrier status for sickle cell anemia; a class action lawsuit against Lawrence Livermore National Laboratory in 1998 for testing its employees for syphilis, pregnancy, and sickle cell without their knowledge; and Burlington Northern Santa Fe Railroad’s decision to perform genetic tests on its employees in 2000 without their knowledge or consent.
"Currently, federal and state laws offer only a patchwork of protection against the misuse of genetic information," PMC’s Abrahams said. "Basic genetic nondiscrimination legal protections need to be established in order to enable and encourage individuals to take advantage of genetic screening, counseling, testing, and the new therapies that will result from the scientific advances in the field of genetics."
Genetic Alliance’s Terry said she is optimistic that “discrimination based on genetics is finally coming on par with racial and gender discrimination. Why it has taken so long for genetic discrimination to become illegal … doesn’t make sense, at least biologically.”

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