Putting a Finger on the Pulse of American Health Care

We subscribe to the Public Citizen Health Research Group monthly newsletter "Health Letter" along with its other monthly edition "Worst Pills, Best Pills." The "Health Letter" examines policy affecting health care. "Worst Pills, Best Pills" deals directly with pharmaceuticals. While my elderly parents were still alive, "Worst Pills, Best Pills" saved their lives. I was able to be a far more assertive advocate with doctors and hospital staffs with the ammunition this newsletter provided. At one point, I learned that my father was taking both Vioxx and Plavix, which was causing internal bleeding that led to severe anemia. His doctor didn't know that the combination could be lethal. I did.

In the December 2008 Health Letter, Public Citizen reviewed some of the worst in health in 2008. The first story affects me. It took 21 months after the completion of the study to reveal that Vytorin, a combination of Zetia and Zocor, used to allegedly treat both genetic as well as environmental causes of higher cholesterol, and which cost 16 times more than the generic of Zocor, was no more effective than Zocor alone in decreasing plaque deposits in the arterial system. When I read about the study in the New York Times, I immediately called my doctor and demanded to be placed on generic Zocor. My monthly costs went from $50 to $25.

The disturbing fact is that the US Supreme Court also held in 2008 in a case Riegel v. Medtronic, that patients injured by medical devices cannot sue manufacturers, because the FDA, whose judgment was highly suspect in the Vytorin instance, is the "first and final arbiter of safety." A similar case involving a drug Rezulin was decided 4-4 by the highest court in Warner-Lambert Co. v. Kent, leaving it unclear whether FDA approval of a pharmaceutical will also confer immunity on the manufacturer of a defective or dangerous drug.

Now awaiting decision is Wyeth v. Levine, argued earlier this fall asking the exact question: whether the Food and Drug Administration's approval of a drug's label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

No matter what the Supreme Court said in Riegel or will say in Wyeth, the Congress can change the authority of the FDA so that private enforcement actions are once again permitted. This is an essential must for the new Democratic Congress. Private enforcement actions keep manufacturers at least a little wary about what they throw into the marketplace. We need to protect ourselves from the same sloppiness and greed that got us into the mire of 2008.