As I see it

Share this article:
Look for more Avandias. Regardless of the anti-diabetes drug's medical merits, the recent furor surely opens an era of politico-medical soap operas that will ensnare other drugs.

The ingredients threaten any marketer of a blockbuster drug. First, you need a politically aware scientist with a credible track record. Second, add some disquiet over the competence of the FDA. Third, throw in a measure of statistics on unforeseen adverse events. Broil under a media spotlight, and watch as another marketer plummets.

Since all new drugs are apt to harbor unforeseen adverse effects, all may be for this kind of unwanted publicity. In Avandia's case, the esteemed Cleveland Clinic cardiologist Steven Nissen was exposed as having collaborated with House Democrats and the New England Journal of Medicine to embarrass the FDA and put GlaxoSmithKline's stock prices into a tailspin over heart attack risks Nissen had uncovered in an unprescriptive meta-analysis.

Adding fuel to the fire was FDA's own untidy house. Its deputy director for drug risk evaluation, Rosemary Johann-Liang, publicly quit after being privately reprimanded by her boss for approving a stronger warning label for Avandia and Actos. Another FDAer, spokesman Doug Arbesfeld, was caught taking Avandia's side in an e-mail to reporters headed “What are St. Steven's feet made of? Clay, perhaps?” in which he seemed to endorse a Wall Street Journal online blogger's comment: “Wake up, pharmaceutical companies…if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.” Arbesfeld was rebuked by commissioner Andrew von Eschenbach for this, but experience teaches that you can expect few others, in the FDA or beyond, to learn from the episode.

Dickinson is editor of Dickinson's FDA Webview (

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in As I See It

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in As I See It

As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications