Docs Ignore Patient Complaints Of Side Effects
5 CommentsBy Ed Silverman // August 23rd, 2007 // 10:45 am
A new study of 650 patients who were prescribed a cholesterol med found that 87 percent who experienced an adverse symptom, such as memory or nerve pain, or memory loss, spoke to their doc about a possible connection. Most of the time, patients initiated discussion of a possible link between the drug and the side effects. And the docs were very likely to dismiss a connection even when literature existed to support the contention.
“A number of patients stated their physician attributed their problems to age or imagination, dismissed the importance of their symptoms or stated that a connection of symptoms to statins was not possible,” wrote the researchers in the latest issue of Drug Safety. “Assuming that physicians would not likely report adverse drug reactions in these instances, these patient-submitted ADR reports suggest that targeting patients may boost the yield of ADR reporting systems.” (Look here for the study).
In other words, docs need to pay more attention to what their patients are saying (yes, we know time is at a premium, but there is an obligation here; no need to discuss time spent at free CME dinners). And if more patients were encouraged to report their side effects to, say, the FDA’s Medwatch program, perhaps safety data would be more informative and timely.
Hank
As most of your porbably know, the general guess is that roughly 1-10% of AEs get reported, probably closer to 1. Obviously, that’s one reason why our drug safety system needs a radical overhaul.
One surprising experience of my own. I experienced an AE seven years ago on an eyedrop that was reconfirmed on three rechallenges. It was more or less ignored at the time. But I have recently heard from the opthy I was then seeing. He is having one of his fellows do some research on this - it turns out more of the same AEs are “showing up” since my own.
An article in a major Opthy journal, as could happen with this, would almost certainly mean more than something buried at CDER or in a company file.
Doc
Talk to any MD who has reported an AE, there is so much paper work involved, unless it is life threating, most docs will not take the time.
Laurie
An informal survey that I did at work showed that about 99% of docs didn’t even know about the Adverse Reaction reporting system online.
Melody
I believe the 3 comments above are indicative of the state of our Adverse Event Reporting system. MOST doctors are not even aware of it. Those who ARE aware of it recognize the voluminous paper trail involved in reporting . . . so it’s easier to “blame the patient”–you’re getting old, it’s probably something you ate, I’ve never heard of side effects you describe, etc. etc.
The primary failure, however, appears to be the convoluted and disparate “categories” one must select to report–which leads to a world of confusion and obfuscation, allowing plenty of room for pharma to deny that there was “significant” reporting of problems, and also giving FDA a goodly amount of wiggle room. Consider, for example, a report addressing “pain” as an adverse event: a “twitch” is not the same thing as a “twinge” which differs from an “ache” or “dull pain” and of course is much different from “intense pain.” So until ALL categories have been addressed and reports allowed to accumulate till significant numbers are attained, pharma, FDA, MD’s can all “truthfully” state that there was not enough data to signify that Drug X causes unexpected “pain” as an adverse event.
As seen with Vioxx, Avandia, etc. –it takes a pile of bodies to attract notice.
Oma Pollard
I am a 65 yr.old woman who was still strong and able to work and walk 5 to 6 miles every morning until my Doc. put me on cholesterol lowering meds. I have taken 3 different ones with worsening side effects from each one. My health is so bad I gave up walking.In fact I have to pull myself up the front steps to the house.All my muscles ache and cramp.I fear that these medications have undone most of the good that cataract surgery made in my vision.I have headaches and dizzy spells.I worry that this damage is permament.What should I do?