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HHS Chief Leavitt May Leave in ’09; Vows To Keep Personalized Medicine Center Stage

Michael Leavitt may soon step down as secretary of the Department of Health and Human Services, but the momentum in personalized healthcare he helped create when he took office two years ago will continue after he leaves, he said at a recent conference.
Speaking at a personalized healthcare conference hosted by the Harvard-Partners Center for Genetics and Genomics Nov. 29, Leavitt said he does not expect to stay on as HHS secretary after President George W. Bush leaves office in January 2009.
However, Leavitt and his staff, which is working as if they have just over 400 days left on the job, are trying to ensure that the personalized healthcare initiatives they launched remain after their tenure runs out, he said.
“I have the rare privilege of doing public service,” Leavitt told conference attendees. “It has a finite period of time … 418 days from now.”  
He said he recently gave every member of his team a clock to put on their desk to remind them of the short time they have left in which to advance certain healthcare initiatives. “We call it our urgency meter,” Leavitt said. “There is a long list of things we want to get done. I’m savoring every single day. What happens after 418 days, I don’t know. What I do know is that I’m going to use every single one of those days to drive missions forward.”
Leavitt is largely regarded by stakeholders in personalized medicine as a champion for the advancement of genetics and genomics research. During his time as HHS Secretary, Leavitt’s administration has released draft reports on pharmacogenomics, genetic testing oversight, and a final report on the reimbursement of genetic tests.
According to Leavitt, in order to bring about more personalized medicine, the healthcare system will need to stand on four cornerstones: electronic medical records to bring connectivity to the system; the capacity to measure healthcare quality in a standardized way; mechanisms to allow consumers to compare prices; and aligned incentives so “all stakeholders are motivated by the desire to provide higher quality healthcare at lower costs.”
Bringing together disparate fiefdoms under HHS with the aim to further the personalized healthcare agenda has been one of Leavitt’s main accomplishments, he assessed.
“I’m persuaded that personalized healthcare creates value,” he said. However, while “there are many different people pursuing this vision from many different angles, I became persuaded over the period of a very short time at HHS [that] many of them weren’t aware of the others, much less were they coordinated.”
At the start of his tenure at HHS, Leavitt gathered the heads of all HHS agencies to discuss what could be done to get more in lock-step.
“We brought together the ‘A Team,’” including FDA Commissioner Andrew von Eschenbach, the Centers for Disease Control and Prevention Director Julie Gerberding, and the National Institutes of Health Director Elias Zerhouni, among others, and “began developing a strategy to take the resources at HHS to drive toward that vision,” Leavitt said.
One venture born from this collaboration was a personalized healthcare workgroup under the American Health Information Community – a public-private advisory committee formed in late 2005 to advance the development of electronic health records. The workgroup aims to incorporate genetic test data into a broader health IT initiative [see PGx Reporter 11-01-2006].
“One of the things [former National Health Information Technology Coordinator] David Brailer said was: ‘The great thing about healthcare standards is that there are so many to choose from,’” Leavitt quipped. “Well, we have to standardize that … so electronic medical records, as they are created, can take this vast array of [genomic] information and begin to combine it in ways that are privacy protected and appropriate.”
Early next year, this working group is slated to release recommendations for incorporating genetic information into standardized electronic medical records.

“When my 418 days are over, yours will continue.”

During his HPCGG talk, Leavitt lauded the CDC for its Evaluation of Genomic Applications in Practice and Prevention initiative, which seeks to establish an evidence-based process for assessing genetic technologies slated for broad public use.
Recognizing that a carrot could help such an initiative, he said that the NIH can drive the adoption of evidence standards developed under EGAPP by requiring test developers to meet these standards in order to receive NIH grants for their projects.
Though such an incentive doesn’t exist today, it’s “the kind of cohesive strategy that we’re all going to have to deploy if we’re going to drive the standards and best practices necessary to make this happen,” Leavitt said.
One highly politicized issue in the area of personalized medicine that Leavitt expressed concern about was the Genetic Information Nondiscrimination Act, a bill that would prevent insurance companies and employers from discriminating based on genetic information.
Although the US House of Representatives recently voted to pass the bill after 12 years of blocking it from coming to a vote, GINA is now being held up in the Senate by Republican Senator Tom Coburn.
At the conference, Leavitt expressed confidence that despite Coburn’s lone political opposition, the bill would be passed by the current Congress and be signed into law by President Bush.
Overall, Leavitt maintained that there is “a cohesive strategy coming together” to advance personalized medicine. He assured conference attendees that the initiatives started during his time at HHS would continue despite the end of his tenure. “When my 418 days are over, yours will continue,” he said to the conference participants.
Certainly, there is a good chance that the national focus on genomic technologies and personalized medicine will not be lost in 2009. For instance, Democratic presidential candidate Senator Barack Obama has introduced a bill on personalized medicine [see PGx Reporter 11-21-2006] that has enjoyed some early success on Capitol Hill.
“When Secretary Leavitt leaves office in January 2009, there will still be many things that will need to be put in place to develop the personalized medicine agenda,” Edward Abrahams, executive director of the Personalized Medicine Coalition, told Pharmacogenomics Reporter this week. Abrahams was present at the HPCGG meeting and led a separate panel discussion.
According to Abrahams, the PMC will release its personalized medicine agenda in early 2008. The areas of necessary focus to help drive the personalized medicine agenda forward include new business models for drug and diagnostics development, an improved reimbursement system for genetic tests, a regulatory process that encourages drug/diagnostic co-development, and physician education.
“This is a tall agenda that’s not going to be done in the first hundred days or all next year,” Abrahams said. “But these are important initiatives. No one thought this was going to be easy or depend on the efforts of an administration or single individual.”

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