Pressure On Fda Threatens Consumer Diet-Drug Fiasco Could Happen Again, Doctors And Consumer Groups Warn

The diet-drug fiasco has consumer groups and doctors issuing their own warning: It could happen again.

The Food and Drug Administration is under intense pressure to approve new drugs faster - even now Congress is trying to further speed the process. Yet the country has no foolproof way to catch surprise side effects like the heart damage that forced two diet drugs off the market this week after millions of Americans had taken them.

“This is a tragedy and a disaster,” said Dr. Raymond Woosley of Georgetown University. And he warned: “As we get drugs approved more rapidly, it will happen more often.”

Woosley joined a group of drug-safety experts who urged the government Tuesday to establish an independent Center for Drug Surveillance to monitor the nation’s 3,200 prescription drugs for unexpected safety problems, much as the National Transportation Safety Board investigates plane crashes.

For $100 million - or half a penny for every prescription written - such a center could provide a better early-warning system, Woosley said.

The FDA acknowledges that its own drug monitoring needs improvement. Today, the FDA relies mostly on physicians voluntarily reporting side effects to an agency program called MedWatch, and then on the FDA’s handful of MedWatch employees spotting a dangerous trend.

“I’ve been real unhappy about our internal system,” said FDA drug evaluation director Dr. Janet Woodcock, who said the MedWatch program will be updated and computerized to better detect potential problems.

Today, the MedWatch office has four employees and a $140,000 budget. Drug monitoring is supplemented by staffs from elsewhere in the FDA, but the agency couldn’t provide a total.

Stopping sales of already approved drugs is fairly rare. Counting the diet drugs Redux and Pondimin, withdrawn on Monday, only 13 drugs have been pulled off the market since 1980.

The discovery that the diet drugs could seriously damage patients’ heart valves came somewhat by chance.

A North Dakota laboratory technician spotted the first two possible cases three years ago when she questioned two women whose heart tests showed very unusual valve damage. Both took Pondimin together with another diet drug. Her curiosity prompted a Mayo Clinic study of the possible side effect. But Woodcock said the FDA didn’t learn about the potential problem until April, three months before Mayo finished its study and issued the first public warnings.

The diet drugs were unusual. Pondimin has been sold since 1973, but wasn’t used widely until the early 1990s, when it was combined with another drug as the popular “fen-phen” combination. The FDA never approved the drug mix, but doctors can prescribe medicines as they see fit.

Meanwhile, the FDA agonized over approving Pondimin’s chemical cousin, Redux. It can increase the risk of a rare but potentially fatal condition called pulmonary hypertension, and high doses in animals killed brain cells, something never studied in people. But obesity experts argued that fat kills, too, and the FDA last year decided that Redux’s benefits for very overweight people made the risks acceptable - until the worse heart risk became known.

But millions flocked to both drugs. Some diet clinics advertised them as largely risk-free, providing them even to people who needed to shed just 10 or 20 pounds, said Larry Sasich of the consumer advocacy group Public Citizen.

How to balance speeding new drugs to patients who desperately need them while ensuring the public isn’t put at risk has been the question for Congress, which for three years has struggled with legislation to speed up the FDA’s work.

Every day that the agency sits on a new drug is a day that a desperately ill patient could die, critics charge.

On the other hand, “a weak FDA can kill innocent patients,” Sen. Edward Kennedy, D-Mass., said Tuesday, telling the Senate why he had insisted on changes to pending FDA reform legislation.

Over time, the Senate bill backed off critics’ original demands to penalize the FDA if it didn’t take certain steps to work faster.

The drug industry says the system works to catch unexpected side effects.

And the FDA notes that while the diet drugs were sold worldwide, no other government caught the heart risk, either.

Still, “are we ever fully prepared for the unexpected?” asked FDA’s acting commissioner, Dr. Michael Friedman. “If we answer yes, we’re self-satisfied and too comfortable.”

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