Personalized Medicine Coalition Applauds New Report
News Oct 15, 2008
But the federal government will have to play a bigger role in funding and coordinating research while also eliminating regulatory and reimbursement hurdles that currently hinder the creation and adoption of innovative products and medical treatments.
“The convergence of scientific opportunity and public health need represented by personalized medicine warrants significant public and private sector action to realize the development of a promising new class of new medical products,” write John H. Marburger III, director of the White House Office of Science and Technology Policy, and E. Floyd Kvamme, co-chair of the President’s Council of Advisors on Science and Technology (PCAST), in a letter accompanying the report.
The 63-page report, Priorities for Personalized Medicine, is a blueprint for eliminating some of the barriers that prevent widespread adoption of personalized medicine by healthcare providers. Those barriers include: ambiguous and incomplete regulation of genomic-based tools and services; limited coverage of genetic tests and treatments by health insurers, including the federal government; and a lack of so-called translational research—research that is necessary to bring new scientific advances to market. The report, which was released in September, is the result of a study by PCAST, a group of leading private-sector, university and other officials who counsel the president on science policy, under the leadership of M. Kathleen Behrens, a general partner with RS & Co. Venture Partners IV in San Francisco, California.
Great strides have been made in basic research and in developing diagnostic tools using genomics, Dr. Behrens says. But much more needs to be done.
“The ability to target treatments is changing the way we think about the role of diagnostics in healthcare,” she says. “Genomics-based molecular diagnostics are but the start of a range of new products and services that will increase the value of diagnostic information in improving the quality of patient care and, longer term, have the potential to help manage costs.”
The Personalized Medicine Coalition will use the findings of the report to advocate for the advancement of personalized medicine, says Edward Abrahams, the Coalition’s executive director.
“No matter who wins the White House in November, this report will help us advance personalized medicine because it offers an objective look at eliminating important obstacles to its development,” he says. “Dr. Behrens has provided leadership and insight that should inform the debate about healthcare in 2009.”
Among the significant scientific roadblocks to widespread clinical adoption of genomics-based molecular diagnostics is the lack of follow-up research to validate genetic markers that have been identified by early research, the report says. Because the validation of genomic correlations with disease is a new, expensive and high-risk research area, the government will need to work with the private sector to make sure the research gets done. The report also recommends that government and industry join forces to create new tools that will facilitate further research, including a collection of high-quality biological specimens accompanied by comprehensive disease annotation.
While the U.S. Food and Drug Administration (FDA) has made progress in developing regulations for genomics-based molecular diagnostics, the report says that FDA’s guidance remains ambiguous or incomplete in several important areas, and that the Critical Path Initiative launched by FDA in 2004, which is designed to help smooth development of drugs and devices, must be fully funded.
The authors identify a number of challenges to containing health-care costs without obstructing the adoption of genomics-based molecular diagnostics. Among them is the fact that such tests are currently reimbursed at the same rate as other laboratory tests. According to the report, public and private payers should set reimbursement rates for genomics-based molecular diagnostics based on their value in patient care. They also should help develop standards for clinical-trial designs that they would accept as providing sufficient evidence to cover a particular test, the report concludes.
Personalized medicine envisions linking drug discovery, development and delivery to emerging molecular diagnostics, informed by powerful new health information technologies, as a way to improve health and lower overall costs.