Uncle Sam, Medical Expert?

How much of a role should the U.S. government assume in ensuring the quality and safety of medical care?

Recent events are sure to unleash a new round of debate.

Yesterday, the U.S. Supreme Court ruled that patients injured by a drug can sue its manufacturer for damages even if the drug was granted FDA approval. Consumer advocates applauded. Drug manufacturers lamented. Lawyers smiled. No longer was the FDA deemed to be the final authority on drug safety. A precedent was set, affirming the check and balance of  the tort system and Federal regulation.

Two weeks ago, the $787 billion stimulus bill provided $1.1 billion to the Health and Human Services Department to research the comparative effectiveness of drugs, medical devices, surgery and other treatments for specific conditions. Consumer advocates, labor unions and large employers applauded. Lobbyists, minority groups and conservative lawmakers expressed concern. Would the government-sponsored research truly improve quality and efficiency by eliminating ineffective care? Or would insurers and Medicare use the data to ration care and drive down costs?

New treatment guidelines from HHS, developed over broad population groups, could run the risk of producing bad outcomes in certain individuals. If that happens, would HHS, the new authority on medical effectiveness, find itself in the same boat as the FDA—with regulators wringing their hands and lawyers licking their chops?

We've cast Uncle Sam in the role of medical expert. Is he truly up to the task?

—Tom DeSanto