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Robert M. Goldberg warns that these Washingtonians could warp genomics progress

 

Robert Goldberg is a senior fellow at the National Center for Policy Analysis and a senior research fellow at the Ethics and Public Policy Center. You can e-mail him at [email protected]

The energy crisis in California is a bellwether of what awaits medical progress and the fledgling genomics industry if some of the more uninformed policies in Congress and the new Bush administration make their way into law and government regulation.

The Washington Post’s Robert Samuelson wrote of the California power situation: “We Americans want it all: endless and secure energy supplies; low prices; no pollution; less global warming; no new power plants (or oil and gas drilling, either) near people or pristine places. This is a wonderful wish list, whose only shortcoming is the minor inconvenience of massive inconsistency.”

We are equally deluded about how to produce cures and treatments for such diseases as cancer, stroke, diabetes, AIDS, heart disease, Parkinson’s, Alzheimer’s, and many other rare and fatal disorders. We want it all: A steady flow of breakthrough drugs at Price Club prices; massive amounts of investment in new scientific discoveries by drug companies who are faced with limited patents; and increased research by academics who must never profit from their own invention or genius.

Indeed, the undercurrent in Washington is to fashion a biomedical investment policy along just those lines. It would turn the genomics industry into California’s power system. Consider just two of the most dangerous ideas and their proponents.

Genomics enemy #1: Ron Wyden (D-Ore.) For years, Wyden has wanted to impose price controls on any drug developed in collaboration with the National Institutes of Health. This year Wyden plans to introduce a bill that would require grantees or their beneficiaries to repay the government for research awards that lead to the development of successful drugs or medical devices, and to pay royalties on any net sales of more than $500 million.

One absurd example: Eli Lilly should “pay” for basic research done on serotonin in the 1950s by an NIH scientist. It would follow that, because Celera benefited from government-funded research done at the Institute for Genomic Research, Craig Venter should make Francis Collins a partner.

I would be interested in hearing from genomics folks who have been NIH grantees. How would Wyden’s plan affect your ability to raise capital? His proposal would kill the free exchange of research and dollars that makes America the center of biomedical innovation in the world.

Genomics enemy #2: Henry Waxman (D-Calif.) Apart from proposing price controls on prescription drugs, Waxman, the ranking Democrat on the House Commerce health subcommittee, proposes limiting patent life on biotechnology and pharmaceutical products to allow generics to enter the market earlier.

The so-called Hatch-Waxman Act would permit generics to be approved five years after a drug has been introduced without allowing for the fact that the drug might have waited that long for FDA approval.

Biotech and genomic companies need changes in patent law that reflect long lead times and the need to raise capital along the way. At an absolute minimum, companies should be compensated for each day that their technology is hung up in the approval pipeline. Waxman, along with groups such as the Nader-led Public Citizen, oppose providing additional incentives for biomedical innovation through patent reforms.

Price controls on new drugs? Handcuffing scientists to a payback formula that exists in no other nation? Shortening patent life?

Are we digging ourselves a California-size hole at a time of great scientific opportunity? Only time ¯ and your reaction to these proposals ¯ will tell.

Opposite Strand is a forum for readers to express opinions and ideas about trends and issues in genomics. Submissions should be kept to 550 words and may be submitted to [email protected]

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