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Personalized Medicine Policy Advocates Have High Hopes for New President

NEW YORK (GenomeWeb News) – Now that the US presidential election has drawn to a close, the scientific community is likely wondering how Barack Obama’s administration will tackle the myriad issues facing the genomics and personalized medicine fields, and what his election will mean for life sciences funding.  
The funding question, particularly for the National Institutes of Health, will be the most pressing. President-elect Obama will arrive to the Oval Office in the midst of a financial crisis, and will be confronted with a 2009 federal budget that has yet to be agreed upon.
NIH "has been historically challenged, regardless of the funding amounts, with doing more than just basic biomedical research,” Genetic Alliance President and CEO Sharon Terry told GenomeWeb Daily News on Thursday.
Terry also thinks that the Chicago politician’s “integrated vision for a modern, evidence-based and effective health care delivery system … can only mean positive things for personalized medicine products and services.”
Obama has previously said that he would like to see funding for NIH boosted along a plotline that would see it double over ten years. Currently, NIH is funded under a continuing resolution until the new budget arrives. The Bush administration’s current budget proposal for 2009 asks Congress for $29.47 billion for NIH, which is around the same amount of funding as fiscal 2008.
During the past year, many in the research community said that flattening budgets are squelching innovation and drying up the US’ talent pool of young scientists.
The Federation of American Societies for Experimental Biology called for increases in funds for most of the agencies that back genomics research, including $31.2 billion for the NIH. In spite of federal belt-tightening, FASEB is now looking forward to helping to “fulfill President-elect Obama's promise of increasing the NIH budget,” FASEB’s Director of Scientific Affairs and Communications Carrie Wolinetz told GWDN this week.
“Obviously the economic situation is going to be a tremendous challenge for policymakers and the entire nation,” Wolinetz wrote in an e-mail. But, she added, “All indications suggest” that Obama and leaders in Congress “have an appreciation for the importance of science and medical research.”
“FASEB is optimistic that science will enjoy a much higher level of importance in policymaking” under an Obama administration, she concluded.
“The real question becomes what happens in the FY2010 budget," said Daryl Pritchard, director of research programs advocacy for the Biotechnology Industry Organization. "The numbers in the 2009 budget would probably be limited to what we’re seeking in the [House of Representatives’] bill ,” he told GWDN, estimating that that would amount to around a three percent increase over 2009.

How much funding NIH receives is only part of the issue. How that money is used also is an important consideration.

“The rising cost of healthcare will be one of Obama’s many challenges and personalized medicine is a bold new approach to improving healthcare while lowering costs; Obama understands this,” Personalized Medicine Coalition Public Policy Director Amy Miller told GWDN in an e-mail.
In a debate in September with a representative for Senator John McCain (R – Ariz.), Obama health policy advisor Dora Hughes said that Senator Obama “has been a strong champion for genomics research, for cutting-edge research that could lead to greater prevention, diagnostic, and development tools.”
Obama reinforced Hughes’ affirming characterization by adding several experienced life sciences figures to his campaign’s team of science policy advisors, including geneticists Gilbert Omenn and Harold Varmus.
Omenn is a former president of the American Association for the Advancement of Science, and he is now a professor at the University of Michigan, and leader of the Human Proteome Organization's Human Plasma Proteome Project. Varmus is president of the Memorial Sloan-Kettering Cancer Center, and he was a director of the National Institutes of Health and is a co-founder of the Public Library of Science.
The Genetic Alliance’s Terry said that Obama “has surrounded himself with Nobel Laureates and seasoned domain experts to advise the campaign,” and she called the emphasis on science as a primary domestic agenda “unprecedented.” Genetic Alliance views the campaign’s specific set of advisors as representatives of “a tipping point” for genetics and genomics in public policy, she added.
The president-elect also introduced last year a genomics and personalized medicine bill that, in its 2008 form, would promote genomics and pharmacogenomics studies in government, offer tax credit incentives for genomics research, would start a biobanking initiative, and would aim to develop some oversight for genetic testing.
This bill expired last year and was re-introduced this year by Representative Patrick Kennedy (D – RI) and will be a priority, Hughes said at a meeting on Capitol Hill in July with the Genetic Alliance.
Hughes also said at that meeting that some parts of the bill could be done through other channels if Obama were to win the White House. Terry thinks that the new president could use the executive order privilege “to make things happen quickly and to enforce a sound public approach that could have a profound impact.”
The Kennedy bill would create a Genomics and Personalized Medicine Interagency Working Group that would include the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, and other groups outside of the Department of Health and Human Services.
The National Biobanking Initiative would create a database for collecting and integrating genomics and environmental health data and information. Another section would use funding to improve diagnosis of genetic diseases, and for treatment and counseling. Rep. Kennedy also has added a tax credit for research expenses incurred in the development of a companion diagnostic test.
“As the bill identifies, incentives are necessary for us to realize the potential of personalized medicine,” PMC’s Miller explained. Miller also said that two other ideas PMC has proposed are in one version of the act, including a tax credit for R&D costs and “a streamlined process through FDA for drug-diagnostic tests for pharmaceuticals.”
The bill also proposes using a matrix of oversight for regulating genetic and pharmacogenomic tests, which Terry calls “a mindful approach” that is aware “of the need not to over-regulate this emerging technology.”
“Obama has been one of the foremost leaders in considering genomics and personalized medicine, and this is a great opportunity to work with an administration that’s aware of these issues,” BIO’s Pritchard added.

As an example, Pritchard said, “The genomics bill has specific provisions, and that’s why we can have this conversation about what can be enacted, legislative or executive.”

The Obama administration also is expected to continue the Personalized Health Care initiative that was started by current Department of Health and Human Services Secretary Michael Leavitt. That program aims to link clinical and genomic information, support genetic information discrimination law, ensure accuracy and validity of genetic tests, and develop common policies for access to genomic databases.

Terry told GWDN that the Obama campaign said it expected to continue the PHC initiative at least beyond the beginning of 2009, and that Genetic Alliance hopes that the new administration will “bring discipline and focus to the program” and will be able to effect real change that makes a difference in real health outcomes.
“Personalized medicine could become a catch phrase that becomes a parking lot for hype,” Terry warned. “It is essential it is grounded in the needs of real patients and real healthcare providers – it is transformative, but only when it is also practical and accessible,” she said.

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