Xpectives News

DTC in Perspective: Media Inspired Fear 2

July 8, 2016 by Bob Ehrlich1

I could not leave last week’s column on media inspired patient fear without another example. The excellent New York Times reporter Gina Kolata did a story on patients resisting drug treatment for osteoporosis out of side effect fears. The story in the June 1 New York Times said millions of people were forgoing osteoporosis drugs out of fear from exceedingly rare side effects.

Ms. Kolata highlights the problems doctors are having convincing patients who need drugs to start therapy. Use of these drugs has gone down by 50%. The incidence of broken thighbone side effects is 10-40 patients for every 100,000 and one in 100,000 for broken jawbones. This means millions of sufferers of osteoporosis are needlessly suffering fractures because they fear side effects.

Bob Ehrlich
“FDA needs …much better guidance on quantifying risk.”
-Bob Ehrlich

Who is to blame? The media reports are partially to blame because they do not give the minuscule odds of a side effect compared to the effects of non-treatment. Lawyers are to blame fishing for patients who take these drugs and claim side effects. How many commercials do we see from lawyers listing a litany of drugs that may have caused side effects?

The FDA is to blame for requiring these extremely rare side effects be part of the ads. While every patient should know the risks, saying fatality in an ad without context is a disservice to patients. What we need is a reporting of the odds of a serious side effect, not vague terms like rare. Consumers will overstate the odds if they hear the word death in an ad. I doubt too many consumers would avoid a drug with a one in a 100,000 incidence. To consumers, words like rare could mean 1/100 not 1/100,000.

FDA needs to have a much better guidance on quantifying risk. Serious risks require clear quantitative odds of occurrence. Patients deserve it. The media should also be held to a high standard when doing their sensationalist stories on drug risk. As this article reports, scared patients make irrational risk/benefit decisions.


Bob Ehrlich

One comment

  • Bob Adsit

    July 22, 2016 at 3:21 pm

    Sometimes waiting for the government to take the first step means nothing gets done.

    I wonder if anyone has ever submitted a rough cut to OPDP with concurrent legal supers that clearly show the rate of occurrence of the severe side effect being mentioned in the VO.

    All it takes is for one brand to start doing this and it may become commonplace.

    If OPDP rejects it, they must explain what guideline is being broken.


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