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Published: Monday, 8/23/2004

Don t be too quick to try latest drugs

A new prescription drug just hit the pharmacy shelves after 15 years of research and testing that cost $100 million. The U.S. Food and Drug Administration (FDA) gave the drug an OK as safe and effective. Ads present a glowing image.

Do you want to try the new stuff?

People often jump at the chance, and the promise of a better treatment.

However, there are good reasons to pass up the opportunity to switch to a brand new medicine and stick with an old standby prescription for a while.

Price, of course, is one. New brand name drugs usually carry sticker-shock price tags, while older drugs may be available in inexpensive generic forms.

The new-is-better mindset is another. New may not always be better for everyone. Most new drugs deliver on their promise, and do work better. However, they may not work better for everyone, or they may have the slightest edge over old standby medicines.

Relatively few patients realize that there is another reason for a stand-offish attitude.

FDA s approval of a new drug says little about its rare side effects some of which can be very serious.

Clinical trials done to get FDA approval usually involve only a few thousand patients. That s enough to spot common side effects that might affect 1 person in 500 or 1 in 1,000. But clinical trials often miss rare side effects that occur in 1 in 50,000 people.

Those side effects start surfacing only after a lot of people take a drug. Depending on the drug, that may take months or years. In a very real sense, patients who jump onto a new drug s bandwagon become volunteers in a real-world experiment to uncover its rare side effects.

One of those drug-induced liver damage is an out-of-the-blue lightning bolt that dramatizes the risks of being a pioneer.

Medicines are the No. 1 cause of acute liver failure, including certain older nonprescription drugs like acetaminophen taken by heavy drinkers. People with acute liver failure become seriously ill in a matter of days as their liver stops working normally. Most eventually need a liver transplant. With shortages of donor organs, some die while waiting.

For years, the liver damage problem has been a huge headache for drug manufacturers and FDA watchdogs. They want to detect the side effect before new drugs hit the market. And scientists want to find out what makes small numbers of people vulnerable to liver failure.

The drug-induced liver failure problem stresses the importance of talking with the doctor about the benefits and risks of a new drug. Ask if it really has major benefits, rather than demand a prescription after seeing those direct-to-consumer advertisements.

Drug companies provide a steady flow of new miracle drugs. Consumers tend to welcome them with open mouths. That s one reason why people in the United States will fill 4 billion prescriptions in 2004 double the number in the early 1990s.

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