September 04, 2007
Tuesday AM

Prescription drugs. Many of us can't live without them, yet often we can't live with a particular medication or dose, either.

Surveys and studies tell us that most patients don't feel they've been adequately treated if they leave the doctor's office without a new prescription.

It's a perception hardly discouraged by a steady diet of advertising that urges us to "ask your doctor."

But when a new drug doesn't work out or even makes us feel sicker, it's not so easy to get Doc to take our concerns seriously, a recent study found.

Researchers at the University of California-San Diego surveyed 650 patients who were taking cholesterol-inhibiting drugs called statins, asking them about any adverse reactions and how doctors responded when they mentioned their concerns.

Eighty-seven percent of the patients said they spoke to their doctor about complaints ranging from muscle pain and nerve tingling in the hands and feet to memory problems, and "overwhelmingly (more than 90 percent of the time) it was the patient that initiated the conversation," said Dr. Beatrice Golomb, an associate professor of medicine and lead author of the study, published in the journal Drug Safety.

But more than half the time, the patients said their concerns were dismissed or not taken seriously. "Person after person said their doctors told them symptoms like muscle pain could not have come from the drug," Golomb said, even though numerous published studies and prescribing guides cite such side effects as being common.

Patients were often told the drugs had no side effects, or that "you're just getting old" or "It's your imagination -- you just don't like taking pills."

Golomb said that not only did many of the doctors ignore complaints and miss the opportunity to switch patients to other drugs with less drastic side effects, they also were unlikely to file an "adverse event report" with the U.S. Food and Drug Administration, denying regulators data about the safety of the drugs.

Consumers themselves can file such reports with the FDA, but few do.

Doctors, often pressed for time and loath to bring up potential problems, frequently skip over possible downsides to drugs when they prescribe them in the first place.

A study published last year by researchers at UCLA's School of Medicine, based on videotaped visits and patient surveys, found that while doctors tell patients the purpose of a new drug they're prescribing 87 percent of the time, they explain side effects only about a third of the time.

Of course, patients can and should read the label warnings and consult with their pharmacist about dosing and other issues. But only the doctor who prescribed the drugs can change the dose or switch medicines.

Oh, and about those consumer-oriented drug ads.

Some watchdog groups complain the FDA has taken too little interest in the accuracy and tone of the ads, especially those on television, and takes too long to review and order changes in the spots. A study published earlier this month noted that the agency issued 21 citations for such ads last year, compared with 142 in 1997.

Drug companies have proposed paying a "reviewing" fee to the FDA to allow the agency to hire more people to check the ads, but it's unclear whether that suggestion will be included in a pending overhaul of the FDA's regulatory duties by Congress.

The FDA did announce plans this week to conduct its own study of how consumers react to the upbeat images presented in most TV prescription-drug ads.

The agency said it would study how 2,000 people respond to the ads, and specifically whether the images serve to block out audio warnings about potential side effects.

On the Net:

http://www.fda.gov/medwatch

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