Drug tests: too speedy - or safe enough?

There are "lots of unknowns until any drug is in the real world for some time," says Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

One example is Vioxx. The arthritis drug was allowed onto the market despite what Dr. Topol says were strong clinical indications of safety problems that should have prompted additional testing. In September Merck, the maker of Vioxx, voluntarily removed it from pharmacy shelves after some studies showed it increased the risk of heart disease. Vioxx quickly became popular in part because of heavy direct-to-consumer advertising. It's a prime example, Topol says, of why government should impose a moratorium of a year or two on advertising of new drugs so that their side effects can be monitored before they are widely used.

Others argue for deeper reforms. Currently, drug companies pay for and conduct their own clinical trials and then submit them as evidence to the FDA. Instead, the FDA should design the clinical trials itself and then contract with independent researchers to perform them, says Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest, a consumer advocacy group in Washington. Then "we'll get objective information about drugs."

Though it would mean allocating more money to the FDA, the cost would be more than made up by lower-priced drugs, since the manufacturers would no longer pass the cost of their tests onto consumers, he argues. Many tests are aimed at expanding the market for a drug - searching for new diseases it can treat or new classes of patients - rather than safety, Mr. Goozner says. The FDA could eliminate those tests.

Both critics and defenders of the current system agree that the industry needs better so-called Phase IV testing - the continued surveillance of drugs after they are on the market.

Drug approval shouldn't be "a one-shot thing, the way it's been all these years," Topol says. "We need to change our mind-set." European countries require a five-year mandatory review of all drugs. "One could argue that five years is too long," he says. "There should be a continuous review, especially in the first year or two."

This area is where the FDA is criticized the most, Kaitin says. "I think the FDA will respond to that."

Topol also sees an independent office of drug safety as vital. The FDA has good people, he says, but allowing those who are involved in bringing a drug through clinical trials as quickly as possible to judge safety as well creates an intellectual conflict. "You're much less likely to criticize a drug in the post-approval phase," he says. "And that's why you need an independent group to monitor that doesn't report to the same people."

The public needs accurate information to keep from becoming discouraged and deciding that all drugs are equally bad and that consumers are powerless to do anything about it, Goozner says. Medical reporting that trumpets "hype and hope" headlines only adds to the hype already found in consumer advertising, says the former reporter for the Chicago Tribune.

When Vioxx and other so-called COX-2 inhibitor drugs, now under scrutiny for possibly causing heart problems, first arrived on the market, a major magazine cover story called them "super aspirins," Goozner says, "even though the pain relief was known to be no different" from that of earlier drugs.

• Thirteen large drug-buying nations spent $341.9 billion on retail medication in the 12 months ending last October. The United States alone accounted for half of that total.

• The US also spent the most per capita ($590.72) compared with Japan ($440.34) and France ($343.42). Brazil spent the least ($26.43).

• The world's bestselling drug is Lipitor, used for high cholesterol. Its $10.3 billion in annual sales exceeds the yearly output of Rwanda's economy.

• Drug prices vary greatly even outside the US. South Africans spend 65 times the world price for amitriptyline, used to treat depression; Peruvians pay more than 40 times the market price.

Sources: IMS Health Inc.; US Census Bureau; World Health Organization

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