Diagnostics & Imaging Week Washington Writer

WASHINGTON – Former Speaker of the House Newt Gingrich threw his weight behind a bill that would preclude genetic-based discrimination, a measure that its backers have called integral to the future of personalized medicine, during a gathering last week on Capitol Hill.

The one-time congressional leader, who these days frequently comments on healthcare matters in his capacity as the founder of the Center for Health Transformation (Washington), agreed with other speakers at last week’s session in noting that “people have every reason to be worried about genetic discrimination.”

His address was made to several current House members, including co-sponsors of the Genetic Information Non-Discrimination Act, as well as representatives from the Personalized Medicine Coalition (Washington) and others in related spaces.

A version of the bill to prevent genetic-based insurance or employment prejudice cleared the Senate by a 98-0 vote early this year, and a movement is afoot to bring it to a vote in the House of Representatives before this congressional session ends. Gingrich said there is “no reason for a scheduling impediment,” adding that he would work on the matter with anyone willing to cooperatively tackle the issue.

His support was mirrored by Francis Collins, director of the National Human Genome Research Institute of the National Institutes of Health (NIH; both Bethesda, Maryland), who, as a longtime supporter of genetic privacy, noted during the event that efforts such as the Human Genome Project would not pay dividends without acceptance of genetics in everyday medical practice.

Presently, most states have some law against genetic-based discrimination for health insurance, and 33 have measures in place to prevent workplace discrimination, but previous work to enact federal regulations on both fronts has stalled.

“On this issue, which has been around for 10 or 12 years, it’s the first time I really felt electricity in the air,” said Brian Munroe, president and founder of the Personalized Medicine Coalition.

Notably, he spoke of “a new political dynamic” in which it could become politically dangerous for House leaders to avoid scheduling a vote on the proposed legislation, despite the Senate’s clear backing and the support of the White House administration.

That type of public policy also is favored by many Americans: According to a recent poll conducted by Christy White of Cogent Research, almost three-quarters of those asked said the government should protect the privacy of genetic information. Also according to the poll, Americans are extraordinarily in favor of using genomics to improve healthcare, with large majorities saying that they would like to see pharmacogenomic data used to improve drug safety and efficacy. But they also fear the manipulation of their genetic information without federal regulations in place.

“Without allaying those concerns,” said Edward Abrahams, executive director of the Personalized Medicine Coalition, “medical progress could be slowed.”

Among the poll’s negative findings, 68% said they are concerned about the storage of personal information and access to it, and almost a third said their concern would prevent them from having a genetic test. Further, 69% agreed that insurance companies would deny coverage if a genetic profile indicated a low chance of response.

Munroe, who works as vice president of government relations and public policy at Millennium Pharmaceuticals (Cambridge, Massachusetts), also noted recruitment slowdowns in clinical studies that employ genetic testing because participants fear signing informed consent documents.

“Genetic privacy is part and parcel of a larger platform that personalized medicine needs in order to move forward,” Abrahams told Diagnostics & Imaging Week’s sister publication, BioWorld Today, adding that regulatory and reimbursement issues would impact the use of genetic data in medicine.

Munroe added that while the drug industry supports the genetic privacy legislation, large healthcare payers are relatively silent on the issue and therefore are not a factor. But large employers, represented largely by the National Association of Manufacturers (Washington), remain among its primary opponents due to liability concerns.

“There’s less room, politically, to be on the wrong side of the issue,” Munroe said, later adding that if the bill gets to a vote in the House, “it’s going to pass by a huge margin.”

The Genetic Information Non-Discrimination Act, H.R. 1227, was authored by a bi-partisan syndicate that includes Reps. Judy Biggert (R-Illinois), Anna Eshoo (D-California), Bob Ney (R-Ohio) and Louise Slaughter (D-New York). It has nearly 130 co-sponsors and is identical to S. 306, which in February passed unanimously in the Senate.