Learning the hard lessons of Vioxx

All drugs pose risks, experts warn, and newest products demand extra caution


WASHINGTON / / Even as hundreds of lawsuits over Vioxx focus attention on the integrity of drug manufacturers, former regulators say the public should look more closely at another issue: how medications reach the market.

Doctors and patients, the experts say, should recognize that approval by the Food and Drug Administration doesn't mean anyone should take a drug without concern about the possible effects.

"Prescription drugs aren't pieces of candy," said William W. Vodra, who was associate chief counsel for drugs at the FDA from 1974 to 1979. He is now a Washington lawyer who represents pharmaceutical companies.

The FDA must certify a drug is "safe and effective" before it can be sold in the United States. But experts note that the designation is relative. It means only that the agency figures the drug's benefits outweigh its risks in treating the specific ailment for which it's been approved. It doesn't mean the drug is risk-free.

In fact, Vodra said, the FDA and key members of Congress discussed during the 1970s replacing the term safe with the more equivocal certification that a drug's benefits outweighed its risks. But he said lawmakers viewed the notion as too confusing and politically charged to pursue.

Prescription drugs are riskier to take when they first hit the market, experts say, because clinical testing is limited.

Before approval, pharmaceutical makers usually test a drug on a few thousand people for a year or less. The experts say that's not a big enough sample or enough time to detect rare but serious adverse effects.

Serious problems frequently don't appear until a drug is used by hundreds of thousands -- or even millions -- of customers.

"That's why many people, myself included, try to be prudent about using a product when it's first approved," said Stephen A. Goldman, an independent consultant who from 1995 to 1999 was medical director of the FDA's MedWatch program, which collects reports of serious adverse events.

The pharmaceutical industry, along with the regulators who approve drugs for sale, has been under fire over deaths linked to painkillers such as Vioxx, as well as to antidepressants prescribed to children that may actually induce suicidal thoughts and behavior.

A jury in Texas recently awarded $253 million to the widow of a Vioxx user, who died in 2001 after taking the painkiller for eight months. A jury in New Jersey is hearing another liability trial involving a patient who survived a heart attack four years ago, shortly after he began taking the drug.

Congress has held well-publicized hearings on these issues and is considering reforms. And the FDA has tried to increase public awareness of the risks associated with drugs, especially newly approved drugs.

"Just because a drug is approved by FDA doesn't mean it's risk-free -- all drugs have risks," said John Jenkins, director of the agency's office of new drugs. "You really can't know everything about a drug when it is approved."

Yet many patients still don't appreciate the risks, experts say.

Dr. Jacob E. Teitelbaum, an Annapolis physician who writes about pain management and lectures around the country, says he expects patients to keep asking for prescriptions despite heightened concerns about drug safety "If you have a horrible toothache, are you going to sit there for six weeks?" he said. "Most people eventually give in to the pain."

Many critics blame the drug industry's $4 billion-a-year advertising blitz. They say a never-ending stream of print ads and TV commercials prompts patients to request new drugs, often for unapproved uses -- and encourages doctors to say yes.

This highlights another limitation of FDA approval. Once a drug is approved for a particular problem, doctors are generally free to prescribe it for other uses -- or for that matter, to give children drugs that have been tested only on adults.

Many drug companies have recently agreed to postpone direct advertising to consumers on a brand new drug. Some are running ads with a more thorough discussion of the risks associated with taking the medicine. The ads also encourage patients to consult with their doctors.

But critics, including some members of Congress, say the companies haven't gone far enough. Some want manufacturers to hold off on marketing to consumers for as long as two years or to restrict sales of new drugs until their impact can be studied further.

William Schultz, former deputy commissioner for policy at the FDA from 1994 to 1998, said pharmaceutical companies are reluctant to do that.

"The market pressures are just terrific and oppressive," said Schultz, now a lawyer in Washington who represents drug companies and biotech firms.

He said strengthening FDA regulations is a more practical target, especially since the federal law governing drug approvals is up for renewal in two years.

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