Local Companies Push to Save GINA and Advance Personalized Medicine

It passed the House by a vote of 420 to 3, President Bush is for it, and it has fervent supporters on both sides of the political aisle—but even that didn’t save the Genetic Information Non-Discrimination Act (GINA or S. 358) from unexpectedly stalling in the Senate last spring.

Now, to try and get it moving again, one of the bill’s key supporters, the Washington, DC-based Genetic Alliance has launched a campaign to “turn up the heat” and let lawmakers know “this is a critical issue,” according to Alliance president and CEO Sharon Terry. Anxious to see the bill pass, a large contingent of Boston-area genomics firms is supporting the Genetic Alliance move.

GINA aims to protect people from losing their health insurance or jobs based on genetic test information. Supporters include many biomedical companies, who say the bill is vital to keeping the genomics revolution rolling.

One of the most anticipated fruits of that revolution is personalized medicine—in which drug treatment is tailored to an individual’s biology. Determining that biology can involve genetic tests. “If you want to enroll human subjects in genetic studies, ideally such information can become part of their medical record,” says Raju Kucherlapati, scientific director of Boston-based Harvard-Partners Center for Genetics and Genomics. “People will be reluctant to enroll if they think the information night be used to discriminate against them.”

Many people fear that if information about predisposition to a serious disease goes into their official medical record, insurers or employers will drop them to avoid possibly having to pay for expensive treatments down the road—which is why many women currently getting tested for genes linked to breast cancer already pay for the tests themselves.

GINA’s supporters have been pushing for this legislation for 12 years. “We finally felt certain it was going to pass,” says Patrice Milos, vice president and chief scientific officer at Cambridge-based Helicos, which supports the bill. But then, exploiting an arcane Senate rule, Senator Tom Coburn (R-Oklahoma) placed a hold on the bill, preventing a vote.

The delay has been a serious disappointment to those who, like Kucherlapati, feel “GINA is essential for personalized medicine.” Milos concurs. “As a company that sits at the cutting edge of the science to look at individual sequence data, we think this is critical.”

Kendall Square is one of the birthplaces of genomics. “This is a hotbed of both technologies used to explore the human genome and companies exploiting it for new therapeutics and diagnostics,” says Keith Batchelder, of the consulting firm Genomic Healthcare Strategies, another supporter of the bill. “You’ve got Harvard, Broad, and MIT that have all been at the center of it.”

Surveys suggest fear of discrimination from insurers or employers is one of the major reasons people avoid genetic testing, even when it is advisable because of family history. GINA supporters say this fear seriously impedes research and impacts personal health: People skip screenings that could help them. Some states have passed genetic anti-discrimination laws, but GINA would apply across the entire country.

What’s most frustrating to supporters is that Coburn’s move appears almost whimsical. This is merely one of approximately 90 bills the notorious ‘Dr. No,’ as he has become known, has single-handedly blocked. Others include a gun control bill that even the NRA backed, a bill to prevent suicide among veterans, and one aimed at naming a post office for Rachel Carson. Even Coburn’s fellow Republicans have been miffed by how often he is the lone outlier on a particular bill. (Coburn’s office has not responded to our request for comments.)

The list of GINA supporters is impressive. Organizations such as the Biotechnology Industry Organization (BIO) and the Personalized Medicine Coalition (PMC) have expressed strong support for the bill. (Helicos, BG Medicine, Aureon Laboratories, HistoRx, and numerous other New England-based groups are members of the PMC.) Last week Elizabeth Nabel said that passing GINA would be “the most important step to enable personalized medicine.” Nabel is Director of the National Heart Lung and Blood Institute, and she was speaking at a personalized medicine conference at George Washington University Hospital in D.C. Francis Collins has been a longtime supporter, and he testified to lawmakers about the bill’s importance last spring. Collins, who led the U.S. government team in the race to sequence the human genome, heads the National Institutes of Health’s genomic research program.

The President is also on board. In a 2001 radio address, President Bush said discrimination based on genetic test results “violates our country’s belief in equal treatment and individual merit.” Since GINA has been in process, he has reaffirmed his support.

According to surveys, most Americans are also in favor of outlawing genetic discrimination. “One of the great things about this bill is that it has bilateral support,” says Batchelder. “People are united around this issue.”

Well, not quite everyone is for it. And in this case, one person could be enough to derail it.

A hold is hard to get around. That’s especially true now with the war in Iraq taking up so much discussion time. The bill’s main sponsor, Representative Louise Slaughter (D-New York), has set up a petition to get Coburn to drop his hold, a move the Genetic Alliance is actively supporting in its new campaign. But if he doesn’t back down, the only way around him is to guarantee a huge block of discussion time for the bill—a process called cloture—or to tag it onto something already in process. Terry says she now expects the latter will happen, and that requires keeping the bill on lawmakers’ radar screens.

While they are weary from the long struggle, supporters say they remain determined. “Until we pass this legislation, we are not getting our return on the genome,” Terry says.

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