Monday, December 20, 2004

 

It's like software developers using their customers as beta-testers

Ah the joys of life (and death) in George W. Bush's America. (To be fair, this started under Clinton. But it was a Republican Congress that pushed it.
American consumers suffering as more new drugs debut in U.S., analysis shows

By Tony Pugh and Seth Borenstein, Knight Ridder Newspapers

WASHINGTON - Thousands of Americans are getting sick and many are dying each year from prescription drugs that were pushed onto the U.S. market ahead of the rest of the world.

A Knight Ridder analysis shows that as the number of new drugs given first to Americans has increased, the reports of drug-induced ailments have soared. Yet, even as the deaths and damage have increased, the Food and Drug Administration has never instituted an aggressive system to track the safety of drugs once they're on the market.

Nearly 60 percent of all the genuinely new drugs sold in the world in 2003 - those with active ingredients never before marketed - were first dispensed in America. That's up from about 3 percent 20 years ago when most drugs were first introduced abroad, where the approval process in many countries is much more stringent than in the United States. "We're the guinea pigs in the sense of extensive population exposure," said Dr. Marcus Reidenberg, a professor of pharmacology, medicine and public health at Cornell University Medical School in New York City.

In 1998, the United States surpassed Europe and Japan as the world leader in the introduction of unique medicines. Knight Ridder's analysis found that 72 percent of unique new drugs approved by the FDA in the last six years were sold in America before they were sold in Europe. In the 1980s, most were launched in Europe.

Europeans adopted more aggressive ways to evaluate the safety of drugs already on the market. Great Britain, for example, keeps track of all drugs and how patients react to them and looks for emerging problems.

That may help explain why the number of Americans reporting adverse drug reactions is soaring. The 357,392 bad reactions reported to the FDA in 2003 is more than double 1995's figure and more than four times higher than those reported in 1990.

But the number of adverse drug reactions is growing more than twice as fast as the number of prescriptions being filled in the United States. From 1994 to 2003, the number of bad drug reactions reported jumped 145 percent while the number of prescriptions filled increased 59 percent, Knight Ridder found.

The FDA estimates that about 390,000 adverse reactions will be reported this year. Yet the FDA cautions that the actual number is likely to be between 10 and 100 times higher because of under-reporting.

The issue of drug reaction and monitoring is a simple case of numbers. Before the FDA approves a drug as safe for sale, it's tested on a few thousand people. It's enough of a sample to find big and obvious side effects, the kind that hit maybe one out of every 100 users.

But when drugs are sold commercially and used by millions of patients, rare side effects can show up, some with deadly consequences. A rare side effect that would hurt maybe one person in 10,000 wouldn't show up in the initial study, but it would in the mass marketplace. That's what happened with Vioxx.

"We launch into overuse of these drugs when we don't know their effects," said Dr. Brian Strom, a University of Pennsylvania public health and preventive medicine professor.

The United States became drug makers' choice for new drug debuts after Congress passed the Prescription Drug User Fee Act in 1992. The law allowed drug companies to fund most of the FDA's costs for approving new drugs. In return, the FDA pledged to cut sharply drug approval times. Faster approval of HIV drugs - the legislation's goal - was the first result. Then came a rash of new U.S. drug applications that shifted from Europe and Japan, where approval was relatively slow.

"There's more money here, a bigger market, less price regulation than anywhere else in the world," said Stephen Schondelmeyer, a professor of pharmacy at the University of Minnesota.

Maintaining drug safety while approving more drugs, according to the FDA's Galson, "means that we have to have a robust post-approval program" to detect problems once drugs are on the market.

That's not what the FDA has, says Dr. Wayne Ray, a professor of preventive medicine at Vanderbilt University in Nashville, Tenn. The system, he said, "is broken."

The system is designed to be passive: Doctors, drug companies and patients report adverse reactions to the FDA, which keeps the records in a giant database. What's needed - but not done - is active searching of these records and other databases for patterns of problems and any side effects from new drugs, said experts.

It's not a new problem. Twenty-five years ago next month, Congress' Joint Commission on Prescription Drug Use offered this as its top recommendation: "A systematic and comprehensive system of post-marketing drug surveillance should be developed."

It still hasn't happened.
And it's not likely to, as long as Congress does not increase the FDA's budget. Which it can't, considering the Bush Administration's insistence on pursuing tax cuts, tax cuts, and more tax cuts, leading to ever-increasing budget deficits and accumulated debt, along with war, war, and more war, all of this combining to make increased domestic spending impossible.
"We launch into overuse of these drugs when we don't know their effects," said Dr. Brian Strom, a University of Pennsylvania public health and preventive medicine professor.

That means consumers should be wary.

"If you don't want to be a guinea pig, don't take them for the first couple of years after they've been approved," said Sean Hennessey, a University of Pennsylvania professor of pharmacology and epidemiology. "It's a common teaching in clinical pharmacology that it's never good to be the first person to use a new drug."
It's a libertarian's dreamworld. No regulation before the fact, but plenty of lawsuits after the fact. Trust the marketplace.

Which is cold comfort if you're dead.
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