Are Old Drugs Better than New?

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The release of a new drug is a pretty big deal in the world of medicine. The company that made it will throw a lavish party. The stock market will react to the news. Doctors will be inundated with freebies and trial samples. And now that the Food and Drug Administration has lifted its restrictions against direct advertising, the public too will be assaulted with ad campaigns in newspapers, magazines and television.

As a physician, I often hear from patients who have read about a new medication and want me to write a prescription. To them, I must sound like a stick in the mud. Unless the medication they're taking is not working, however, I'm generally reluctant to change. They assume that newer drugs are better; I assume the old ones are fine.

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So I felt somewhat vindicated last week by a report in the Journal of the American Medical Association about the safety problems associated with new medications. Of 548 drugs approved by the FDA over the past 25 years, fully 20% turned out to have serious or life-threatening effects that were unknown or undisclosed at the time of approval, according to an analysis directed by the Harvard Medical School. Sixteen drugs were subsequently withdrawn from the market, but not before millions of people had been exposed. Seven of those drugs had side effects so serious they were cited as possible contributing factors in 1,002 deaths.

How could this happen? I put the question to Dr. Karen Lasser, the lead author of the study. Basically, she says, "the drugs aren't adequately studied before being released to the public." As she points out, new drugs are tested first on relatively small numbers of users, who in the past tended to be men. It's only when the drugs are marketed to the general population and taken by large numbers of women, children and the elderly that more obscure side effects emerge.

The Pharmaceutical Research and Manufacturers Association took issue with the study, releasing a statement that called it "misinformed and misleading." All medications involve some risk, the drugmakers point out, and some new medications have significant additional benefits that are discovered only after they are approved.

But the drug companies, by marketing their newest products so aggressively, are part of the problem. "They push the public and doctors to use new drugs that are more profitable but also more dangerous," says Dr. Paul Allen, one of the study's co-authors.

That's a message patients should take to heart. Don't assume because you see a lot of ads for a new drug that the one you are taking is obsolete. And if you switch to a new medication, be attuned to any unexpected side effects. The most common adverse reactions include liver toxicity, heart problems and fetal damage.

This is not to say that there aren't plenty of important new drugs in the pipeline. I am sure that if there's a sound reason for doing so, I will still prescribe newly released medications for my patients. But only when absolutely necessary. And then I will keep a very close eye out for any adverse effects.

Dr. Gupta is a neurosurgeon and CNN medical correspondent