CU urges FDA to insist on effective ways to study rimonabant before allowing it into mass market

March 7, 2006
The Honorable Andrew C. von Eschenbach, MD
Acting Commissioner
U.S. Food and Drug Administration
Parklawn Building, 5600 Fishers Lane
Rockville, Maryland 20857
Dear Dr. von Eschenbach:
The New York Times of February 18, 2006 reported that the approval for Sanofi-Aventis’s Acomplia (rimonabant) was delayed, but that an ‘approvable’ letter was issued for weight management (but not for smoking cessation). While no details of the letter were available, the news article quoted sources who speculated that certain rigorous postmarketing surveillance programs or other marketing limitations might be required.
In light of the recent editorial and article in JAMA* , Consumers Union, the independent, non-profit publisher of Consumer Reports urges the FDA to insist on follow-up safety studies and strong label warnings before allowing mass marketing of this product.
The world’s drug companies should be applauded for attempting to find ways to help combat the obesity epidemic, and given the astounding prevalence and cost of obesity, any drug that promises to help address the problem will undoubtedly be widely used for long periods of times.** By the nature of our society and its image consciousness, this drug is likely to be marketed widely and in demand by people who are not obese. But as the JAMA editorial and the article on the drug’s randomized controlled trial makes clear
–the data on this drug effectiveness has been compromised by the very high attrition rates (roughly 50%) and failure to include data on those who dropped out;
–there is “a 2.7 fold higher rate of psychiatric disorders among those receiving the 20-mg dose of rimonabant compared with those receiving placebo (6.2% vs 2.3%); and
–“larger studies are necessary to assess less frequent adverse events and longer duration studies will be needed to confirm the long-term safety of rimonabant beyond 2 years;” and
–the editorial concludes that “drug treatments for obesity should be considered within this broader context [of larger, social responses to the obesity epidemic] and their current role should be limited pending further evidence.”
We hope, therefore, that the FDA will insist on truly effective ways to answer unresolved long-term safety questions and the increased psychiatric disorder issue before this drug is allowed into the mass market.
Thank you for your consideration of this request.
William Vaughan
Senior Policy Analyst
Washington Office
* February 15, 2006 (Vol. 295, No. 7), p. 826-827 and pp 761-775
** The RCT shows that those who stop use after one year and take the placebo in the second year tend to regain much of the weight they lost in the first year, so use for more than a year is likely to be standard.