Healthy Skepticism Library item: 13339

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

King Gets Warning Letter Over Avinza Promotion
PharmaLive 2008 Mar 27
http://pharmalive.com/news/index.cfm?articleID=526338&categoryid=9&newsletter=1

Notes:

Link to FDA warning letter:
http://www.fda.gov/CDER/warn/2008/Avinza-wl.pdf

Link to promotional material:
http://www.fda.gov/CDER/warn/2008/Avinza-Promo.pdf

Full text:

The FDA yesterday posted on its website a warning letter sent to King Pharmaceuticals about promotional material for pain drug Avinza. The agency said it reviewed a 22-page File Card for the drug and found it “false or misleading in that it presents efficacy claims for Avinza but fails to communicate and minimizes risks associated with its use, fails to present the limitations to its approved indication, and presents unsubstantiated efficacy claims.”

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963