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Old 09-13-2007, 04:51 PM
dorsy1943
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Default Re: Drug Side Effects Under-reporting

On Sep 11, 10:37 pm, Alan S <loralgtweightandca...@gmail.com> wrote:
> Came across this on a different group today:http://tinyurl.com/2swp25orhttp://ww...07/08/24/AR200...
>
> "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."
>
> Ishani Ganguli is in her second year of studies at Harvard
> Medical School."
>
> Cheers, Alan, T2, Australia.
> d&e, metformin 1500mg, ezetrol 10mg
> Everything in Moderation - Except Laughter.
> --http://loraldiabetes.blogspot.com


Thanks Alan. I was recently fired by the managing partner of the
medical practice I have been going to for 18 years. He sent me a
letter telling me not to come back. I have only seen him a handful of
times when my regular doctor is not in. I was having chest pains and
gastrointestinal problems which I believe was from the cephelosporin
he prescribed for an infected toe. A culture showed that the toe was
not infected yet he instructed me to continue taking the antibiotic.
I did (what an idiot I was). twenty thousand mgs of an antibiotic and
there was no infection.

I went back to the office to get an EKG and unfortunately he was the
one on duty. First he told me the EKG was normal, but he prescribed a
beta blocker even though he said he didn't think it was a heart
problem. He gave me a scrip for a treadmill test and an upper gi. I
did not follow his orders, prefering to see my regular doctor when she
returned. So he fired me.

Dolores

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  #2  
Old 09-13-2007, 04:51 PM
Alan S
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Posts: n/a
Default Re: Drug Side Effects Under-reporting

On Thu, 13 Sep 2007 04:01:22 -0700, dorsy1943
<dtms69@usadatanet.net> wrote:

>Thanks Alan. I was recently fired by the managing partner of the
>medical practice I have been going to for 18 years. He sent me a
>letter telling me not to come back. I have only seen him a handful of
>times when my regular doctor is not in. I was having chest pains and
>gastrointestinal problems which I believe was from the cephelosporin
>he prescribed for an infected toe. A culture showed that the toe was
>not infected yet he instructed me to continue taking the antibiotic.
>I did (what an idiot I was). twenty thousand mgs of an antibiotic and
>there was no infection.
>
>I went back to the office to get an EKG and unfortunately he was the
>one on duty. First he told me the EKG was normal, but he prescribed a
>beta blocker even though he said he didn't think it was a heart
>problem. He gave me a scrip for a treadmill test and an upper gi. I
>did not follow his orders, prefering to see my regular doctor when she
>returned. So he fired me.
>
>Dolores


Are you able to take any action under your system? Is there
any form of complaint procedure available?


Cheers, Alan, T2, Australia.
d&e, metformin 1500mg, ezetrol 10mg
Everything in Moderation - Except Laughter.
--
http://loraldiabetes.blogspot.com
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