New York Times Series Examines Use of Genetic Tests to Determine Whether Drugs Will Benefit Individuals

The New York Times in an installment of its "The Evidence Gap" series last week examined how "so much hope is riding on the promise of 'personalized medicine,' in which genetic screening and other tests give doctors more evidence for tailoring treatments to patients, potentially improving care and saving money." According to the Times, experts believe that "most drugs, whatever the disease, work for only about half the people who take them." While many policy experts are urging comparative effectiveness studies for different treatments, such studies "tend to be 'one size fits all,' with the winning treatment recommended for everybody," the Times reports. Personalized medicine would allow physicians to determine which drug is best for a particular patient, rather than "continuing to treat everyone the same in hopes of benefiting the fortunate few," the Times reports.

According to the Times, "For all the potential, experts see some formidable obstacles on the path to the promised land of personalized medicine." Gregory Downing, leader of HHS' efforts to promote personalized health care, said, "It's going to take 20 to 30 years for all this to fall into place." Factors that could limit implementation of individual effectiveness testing include drugmakers' reluctance to support something that would limit use of their products and insurers' reluctance to pay for the tests, which can cost "up to a few thousand dollars," according to the Times. In addition, genetic test makers face the "major obstacle" of "proving their products are accurate and useful," the Times reports. Unlike drugs, there is no standard process for evaluating genetic tests, many of which can be marketed by laboratories not approved by FDA. The Times also examined efforts by drugmakers to regulate the use of such tests (Pollack, New York Times, 12/30/08).

Opinion Piece
Personalized medicine "can help direct the right treatment to the right patient" and result in "vast" improvements in health care and cost savings, HHS Secretary Mike Leavitt and Raju Kucherlapati, a professor of genetics and medicine at Harvard Medical School, write in a Boston Globe opinion piece. They state that personalized medicine has "the potential to transform the effectiveness of medical care in the immediate future."

Leavitt and Kucherlapati write that "our conception of disease needs to be more precise in order to better individualize care," adding that the "explosive growth of scientific discoveries at the molecular level, accompanied by advances in technology and analytical capabilities, bring the promise of greater precision and effectiveness in medicine." They continue, "Over time, we should be able to prescribe medicines with foreknowledge as to their effectiveness for individual patients and disease subtypes" and "increased knowledge of genetics and molecular biology should also enable us to detect disease before symptoms appear, making possible earlier treatment and even pre-emption of the disease."

They write that personalized medicine "cannot be implemented if it is going to result in a great increase in health care costs." However, "the practice of personalized medicine can be an important part of achieving higher value in health care" because "[m]ore accurate dosing, enabled by a relatively low-cost genetic test, might save as much as $1 billion per year while delivering better quality care and better health."

Leavitt and Kucherlapati conclude, "We have an important opportunity to improve health and improve value in health care. Let us make personalized medicine an explicit goal of health care reform" (Kucherlapati/Leavitt, Boston Globe, 12/26/08).