Is Your Doctor in Denial?

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Same goes for vaccine injuries

Sheri

" 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. "

http://www.washingtonpost.com/wp-dyn/content/article/2007/08/24/AR2007082401

714.html?nav=rss_health

washingtonpost.com

Is Your Doctor in Denial?

Survey Finds Physicians Often Dismiss Complaints About Drugs' Side Effects

By Ishani Ganguli

Special to The Washington Post

Tuesday, August 28, 2007; HE04

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 & iquest; & frac12;

Ishani Ganguli is in her second year of studies at Harvard Medical School.

Comments:health@....

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm Email classes start

October 17 & 18