Editor's note: the first of this two-article series, "Leavitt outlines 'PGx' for newer, personal, gene-based medicine," appeared in the April 2 edition of MDD.

On the road to what Michael Leavitt, secretary of the Department of Health and Human Services referred to last week as "Personalized Health Care," in a speech before the Personalized Medicine Coalition (PMC; Washington), he said, "much work remains to build a system that can deliver" a customized healthcare based on the genetic differences in individuals — a system that has been dubbed PGx.

"The Human Genome Project was a dramatic success, but it has correctly been called a race to the starting line," he said. "The work that remains is sweeping — from the most fundamental science to the details of healthcare practice."

Current efforts at HHS agencies supporting PGx totaled $277 million in 2007 and an increase to $352 million is being sought in FY08.

But in offering hope for this effort, he added a broad proviso: that this approach to healthcare will utilize a confluence of science and health information technology (HIT), which will generate vast amounts of personal information that will need to be protected.

Leavitt said that HHS is involved in a "broad review of the implications for privacy protection as health information technology is increasingly adopted, including needs for genetic information and the anticipated effect on the confidentiality, privacy and security of individually identifiable health information."

Another measure on which the HHS is focused is the development of "consistent" policies for its agencies regarding "access to and security of federally supported research."

Here, the goal is to ensure open information access for researchers to support progress in the field, while still providing sufficient rewards for discovery and innovation.

Leavitt noted that President Bush's budget for 2008 includes $15 million in start-up funding to create a new electronic network designed to link the nation's major health data repositories.

In parallel to this effort, the American Health Information Community (AHIC) is expected to develop recommendations to identify HIT standards for including genetic test information on electronic health records (EHR), and that coalition issued a statement in support of Leavitt's emphasis on confidentiality.

For PMC, a piece of legislation it is following closely — and specifically targeting privacy of genetic information — is the proposed Genetic Information Nondiscrimination Act of 2005.

Edward Abrahams, PhD, executive director of PMC, told Medical Device Daily that the bill has been marked up, referred to the House, and could be approved as early as the next session of Congress.

Abrahams said the bill contains all the elements to protect consumers' genetic information, including prohibiting employers from discriminating against employees "based on genetic information that is not manifested," he said.

Without such legislation, patient privacy faces an "awful threat," he said.

"Consumer confidence in sharing genetic information with physicians [and] researchers is a critical building block to personalized medicine," Abrahams told MDD, specifically focusing on its impact on trials of new products.

"If right now, patients withdraw from clinical trials that are genetically based, because they don't have confidence that their information wouldn't be used against them, you could see why that would be a great hindrance to medical progress."

The PMC, founded in 2004, is composed of healthcare companies, venture capital firms and government agencies, among others in academia, payer and patient. It was "based on the idea that science and technology alone wasn't going to lead to a new paradigm in drug discovery in medicine," and that this vision can't be realized without everybody — businesses and regulatory agencies — "all rowing in the same direction," Abrahams said.

He said that it was clear from the beginning that what "government did or didn't do" would either advance or "impede" the fulfillment of the goal of these communities to foster.

The gatekeepers for personalized medicine regulation include industry, FDA, as well as CMS and other third-party payers, according to a report produced by the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS).

That report, titled "Realizing the Promise of Pharmacogenomics: Opportunities and Challenges," was distributed at the meeting where Leavitt spoke.

The report says that "HHS agencies are aware of the inconsistencies in federal policies governing clinical research."

It says also: "The NIH is currently dedicating resources to the harmonization of federal policies to address issues related to the protection of human research subjects," and that "broad consent may lead to uninformed choice, while narrow consent can hinder research."

For example, according to the document, SACGHS recommended in its February 2006 report, "Coverage and Reimbursement of Genetic Tests and Services," that it "may be inappropriate for private payers to follow Medicare's lead in the area of genetic testing."

It says that while "generally" PGx tests "to identify which patients among those known to have a particular condition are likely to respond to treatment" are Medicare-eligible, they can also be completed in the absence of symptoms.

"Rather than relying on Congress to pass legislation on an ad hoc basis, adding prevention as a Medicare benefit category would enable HHS to develop coverage and payment policies for particular services in a more systematic manner … ." the report says.

SACGHS said it expects its work on PGx will be completed next year.

The report is available for public comment through June 1.

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