Washington Editor

WASHINGTON - With legislation moving forward to protect patient privacy, Francis Collins, director of the National Human Genome Research Institute, said that "we can't fail to live up to our scientific responsibilities."

An ardent advocate of policy to prevent genomics initiatives from excluding medical treatment based on genetic predisposition, he addressed a crowd gathered last week at the National Press Club. The event was hosted by the Personalized Medicine Coalition, a recently founded non-profit group aimed at educating the public and government on the potential impact of predictive tools on health care.

Collins stressed that consumer protection must be a priority that needs to be addressed through effective legislation. Indeed, a bill could soon be on the Senate floor to tackle that very issue.

"If we don't do this," Collins said, "I can tell you of patients who will be afraid of information that otherwise might be helpful."

Other issues that are rising to the surface as personalized medicine develops relate to validation, regulation and reimbursement. Collins said he favors an approval process for predictive tests that would include several government agencies such as the FDA and Centers for Disease Control and Prevention, as well as professional societies, consumers, health care providers and third-party payers.

Additional concerns relate to the marketing of personalized medicine products, such as a DNA storage kit marketed on the Internet by Target Corp., as well as public and professional education. The U.S. surgeon general's family history initiative is designed to aid in the former, while the latter cause is being taken up by the National Coalition for Health Professional Education in Genetics.

"Individuals alive now, who count on us for the future of medicine, are not going to be well served if we don't tackle some of these difficult problems," Collins said.

He also discussed progress by the International HapMap Consortium, which recently received an additional $3.3 million in public-private support. He said the project would be completed in seven months.

Last week, the consortium said it planned to create a more powerful map of human genetic variation than originally envisioned. The project was launched in October 2002, and by the end of this month, the group will complete its first draft of the human haplotype map. It will consist of 1 million single nucleotide polymorphisms.

The consortium's new version of the HapMap will be about five times denser than the original plan.

The National Human Genome Research Institute is part of the National Institutes of Health in Bethesda, Md.

Biogeneric Event To Be Held This Week

The myriad issues related to generic biologicals will take center stage over the next three days at a scientific workshop on follow-on protein pharmaceuticals to be held in Arlington, Va.

The seminar will examine topics such as the chemistry, manufacturing and controls, pharmacology/toxicology, clinical pharmacology and clinical aspects for assessment of the quality, safety and efficacy of follow-on protein products. It will focus on recombinant and natural protein products that are directly administered to humans. Synthetic peptides, in vitro diagnostics and devices will not be covered.

The FDA and the Drug Information Association are co-sponsoring the event, and the FDA said findings that stem from the workshop will contribute to a foundation it is developing for regulatory guidance.

NIH Pushing For Faster Data Publication

A new voluntary policy at the NIH is urging scientists to publicly release manuscripts from institute-supported research as soon as possible, and within 12 months of final publication.

The mandate is designed to accelerate access to published articles. Such peer-reviewed, NIH-funded research publications will be available in a web-based archive to be managed by the National Library of Medicine, a component of the NIH. The policy conflicts with the traditionally long scientific publication rules, but the NIH said it will create a preserved archive for internal use that would be more accessible to the public, health care providers, educators and scientists.

Beginning May 2, the policy requests that NIH-funded scientists submit an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part by the government organization. The new guidelines allow authors to designate a time frame for public release - ranging from immediate access after final publication to a 12-month delay - when they submit their manuscripts to the NIH.

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