Your Drug Did You Wrong? Call 1-800-Side-Effect
7 CommentsBy Ed Silverman // May 15th, 2008 // 2:59 pm
Right now, that call won’t go through, but an FDA advisory committee will meet tomorrow to discuss the possibility of including in televised DTC ads a statement encouraging consumers to report negative side effects to MedWatch. Right now, such statements are only required for DTC print ads.
The meeting comes amid ongoing debate over DTC ads. A growing chorus of critics say that risks are regularly minimized in favor of feel-good messages that can lead to over-prescribing. Some lawmakers and consumer advocates want toll-free phone numbers placed in the ads in hopes of helping the FDA spot warning signs sooner.
A recent Consumers Union poll found that 81 percent of Americans reported seeing or hearing an ad within 30 days of being questioned. The same poll found that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doc or hospital, but only 35 percent were aware side effects can be reported to the FDA.
Two months ago, the FDA was supposed to have given Congress a report on mandatory contact info in TV ads, but an agency spokeswoman tells the Associated Press that a final version is still being worked on. PhRMA hasn’t taken a stance, but supported adding the side-effect language in print ads.
“If it’s good enough for print, it’s good enough for TV,” Kim Witczak, founder of the WoodyMatters advocacy group, tells the AP. Her husband, Woody, committed suicide while on Pfizer’s antidepressant Zoloft. The following year FDA added warnings about risks of suicidal behavior to all depression drugs.
Last year, the FDA announced plans to study whether TV ads paint an overwhelmingly positive impression, despite audio warnings about potential side effects. And week a House committtee held a hearing about DTC ads.
At the hearing, Duke University professor and linguist Ruth Day testified that advertisers often use faster voice overs and distracting visuals when describing drug side effects during the commercial. She cited Schering Plough ads for the Nasonex allergy med in which a bee buzzes around the screen when side effects are mentioned, but stays put while the benefits are touted.
In her research, Day found that 80 percent of viewers can recall benefits mentioned in TV drug ads, while only 20 percent successfully recall side effects. She also noted the benefits can be understood by anyone with a sixth-grade education, but a ninth-grade education is required for side effect info.
Lilli
Isn’t this the same as calling the FDA to complain about adverse side effects? Congress must have a program where the primary doctors moniotor the adverse side effects from medications. But most doctors do not not–instead if a medication is causing trouble they will give you anothr medication tgat will make more complications.
LILLI
James
LILLI, it seems like you have a lot of complaints, but I have yet to see you propose any solutions.
What would you suggest be done? And I don’t mean “Be ethical and care about people over profits.” What is your solution for the issues you raise? How much would it cost? Where would the funding come from? How would you deal with unintended consequences (e.g. if your plans had a chilling effect on drug development or availability)?
I’m willing to give you the benefit of the doubt, and so I look forward to your response.
Just A Thought
Yes it did.
The number doesn’t work? Try this…
http://www.fda.gov/medwatch/how.htm
CDER, the Energy and Commerce Committee, the USDOJ, Senators, Congressmen, authorities in the field, pharmacy corporate offices, Senior Services (not because you’re a senior but because they are a ‘get it done’ organization), the VA, the AMA, elected officials on the state level, and of course the offending maker. Find an advocacy group and see if others are reporting problems too.
^ For what it’s worth you can start there. ^
(see, people DO know where to report)
“Last year, the FDA announced plans to study whether TV ads paint an overwhelmingly positive impression, despite audio warnings about potential side effects. And week a House committtee held a hearing about DTC ads. ”
Perhaps the money going to this study would be better spent to more quickly process the data to react to adverse events or unanticipated problems.
To protect the post-marketing public.
Lilli
James
This has nothing to do with cost. As I said before Primary care doctors must monitor and report adverse side effects from medications. James I do not think you read but just voice your opinion against me. Most Doctors are not reporting errors from medications—Pharaceutical is in charge with the federal and state legislature, and influencing our health laws. The patient does not have a voice with elected officals in this matter.
Lilli
Laurie
This is a great start! The online medwatch system is not user friendly and few even know of it’s existence. This puts the reporting system’s existence where it should be..with the patient taking the drug.
Sam
Lilli,
It would be nice if primary care doctors were required to monitor and report adverse side effects from medications; however, they aren’t. Such reports from MDs to the FDA are voluntary:
“The FDA receives adverse drug reaction reports from manufacturers as required by regulation. Health care professionals and consumers send reports voluntarily through the MedWatch program.” - http://www.fda.gov/cder/aers/default.htm
Doctors do file adverse reaction reports with the drug manufacturers (if that’s what you mean by “must monitor”) and the manufacturer then reports the adverse reaction to the FDA.
Ask your family doctor if he/she has ever filed an adverse reaction report directly with the FDA using MedWatch. Odds are they haven’t; the FDA’s Adverse Event Reporting System database is mostly filled with reports from the drug manufacturers.
For years consumers have been able to file an adverse reaction report directly to the FDA or through their doctor, but most haven’t known they could (if they even knew that MedWatch existed). The point of putting the message in the DTC tv ads is to make consumers aware of MedWatch and to encourage them to report adverse reactions they experience to the FDA.
Sam
noni
Ahhh that would be no. The point of putting the 1-800 in DTCA bilge is to coat the turd with sugar. When are these people going to quit behaving like 14 year-olds making excuses for missed homework assignments?