By Ishani Ganguli
Special to The Washington Post
Tuesday, August 28, 2007
On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.
According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs.
When doctors fail to recognize a patient's symptoms as drug side effects, more than that patient's care is put at risk. Because the doctor makes no "adverse event report" to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.
Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.
"Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn't have come from the drug. We were surprised at how prevalent that experience was," said Beatrice Golomb, associate professor of medicine and the study's lead researcher.
Tens of millions of people worldwide take statins such as Lipitor and Zocor. Many experts view them as something of a panacea for everything from stroke and cancer to arthritis, although they do pose a risk of side effects in some patients, ranging from muscle injury to liver and kidney dysfunction.
Survey respondents, recruited via Web solicitations and other advertisements, were in their early 60s on average and mostly from the United States. Some of the solicitations were placed on Web sites where patients had posted complaints, raising the possibility that respondents were more apt to have had side effects than the average patient. Most said they'd complained to their doctors about such possible side effects as problems with memory or attention, or tingling or numbness in their hands and feet.
According to experts, muscle pain and other side effects occur in up to 30 percent of statin patients, by some estimates, and often lead doctors to stop or change a prescription. But patients surveyed said their doctors rarely linked their symptoms to statins -- even when the symptoms were well-documented as side effects.
"Overwhelmingly, it was the patient that initiated that conversation" making the connection between the statin and their symptoms, Golomb said.
Many doctors instead attributed the symptoms to the normal aging process, denied their connection to statins or dismissed the symptoms altogether -- missing opportunities to switch their patients' prescriptions or otherwise mitigate the side effects, Golomb said.
Golomb speculated that doctors' actions might reflect the relative dearth of information on the downsides of statins. "Ad campaigns that preserve statins' miracle drug image are more powerful than education about side effects," she said.
The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn, author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs."
"We already know that there is horrendous underreporting of side effects. Ninety to 99 percent of serious side effects are not reported by doctors," he said.
Yet the FDA relies heavily on their reports. Tracking a drug's safety once it hits pharmacies -- so-called post-market surveillance -- is a critical part of keeping patients safe, particularly since clinical trials with limited enrollees and a limited study period cannot catch every side effect.
Managed care deserves some of the blame, Avorn said. "Part of [the problem] is that doctors are granted so few minutes to deal with patient visits. It's not as if doctors don't care."
Golomb and others worry that if even well-documented side effects aren't being recognized by doctors, others will take much longer to surface. "A fifth of all drugs that fully pass FDA approval will ultimately have black box warnings or be withdrawn from market because of adverse effects," Golomb said.
Some say that the FDA and drug companies should work harder to get feedback directly from patients. Getting drug surveillance reports from patients is common practice in New Zealand and other countries.
U.S. patients can report side effects to the FDA themselves -- by logging onto the MedWatch Web site ( http://www.fda.gov/medwatch). But few know about this option, Avorn said.
The new study "points out that doctor reports on side effects is a very unreliable means of learning about the true extent of problems," he said. "We ought to have a [better] mechanism for gathering information from patients. A lot of it will be noise, but there may be important signals there as well." ï¿½
Ishani Ganguli is in her second year of studies at Harvard Medical School. Comments:firstname.lastname@example.org.