Along with creating the opportunity for healthcare providers to use genetic tests to optimize treatment, the updated labeling on warfarin approved by the U.S. Food and Drug Administration (FDA) raises a number of issues. The labeling changes were based on an analysis of recent studies that found people respond to the drug differently, based, in part, on whether they have variations of certain genes (CYP2C9 and VKORC1).

This is widely referred to as “personalized medicine,” an approach that is raising concerns not only among healthcare providers but also among manufacturers, policymakers, and patients.

Ideally, personalized medicine would use new methods of genetic testing both to test a patient’s predisposition to a disease and to determine optimal treatment protocols, such as drug dosages. Ultimately, such an approach would help physicians and their patients choose the best individual disease management approach. It also is expected to be used in developing new treatments and identifying subgroups of patients who might be susceptible to certain diseases.

In practice, however, personalized medicine will carry with it a number of public policy and legal issues that will have a significant impact on both healthcare providers and their patients. Such issues need to be explored and carefully considered, according to genetics and law experts.

The liability issue
Incorporating personalized medicine into everyday clinical practice faces significant hurdles, including scientific uncertainty as well as social and economic concerns. But the risk of liability for not incorporating pharmacogenomic testing could serve as a catalyst for change.

“Legal liability is a powerful driver that could dramatically hasten the development of personalized medicine,” according to a commentary by genetics and law experts at the Sandra Day O’Connor College of Law, which appeared in the journal Personalized Medicine (November 2006, Vol. 3, No. 4, Pages 391-397; summary available online at http://www.futuremedicine.com).

“Physicians are the sitting ducks in this new class of litigation, both because they lack the legal defenses available to other parties, and because many doctors have not received the training in genetics they need in the new world of personalized medicine,” said Gary Marchant, executive director of the Center for the Study of Law, Science & Technology at Arizona State University, who coauthored the article.

Lawsuits already have been filed claiming physicians should be liable for not recommending or performing certain genetic tests. The next step, according to the authors, will be lawsuits for failing to recommend genetic tests before prescribing medications. The new warfarin labeling may increase this trend.

“If significant liability does occur, its effect will be dramatic, as potentially liable parties will need to undertake immediate and significant changes to protect against large legal liabilities,” the authors concluded. “Manufacturers and healthcare providers, and the attorneys representing them, should start preparing now for preventing and defending a new class of personalized medicine lawsuits.”

Additional hurdles
Some of the other hurdles that healthcare providers, healthcare associations, and legislators will face in implementing personalized medicine practices include the following: preventing healthcare discrimination; creating infrastructure and providing access to data for secondary uses, such as risk prediction; providing genetics education for both healthcare providers and patients; and funding.

These issues will be explored in upcoming editions of AAOS Now.

Starr McCaffery is a communications consultant working with the AAOS Washington, D.C., office.