Sanofi Diet Drug Gets Raves, Caution from Doctors

At a time when the drug industry is being pounded with recalls and government investigations while turning out few major new drugs, French drugmaker Sanofi-Aventis appears to have a big winner on its hands.

Data from a two-year study of the diet drug Acomplia showed that it helped obese patients loose nearly four times as much weight as those taking a placebo and keep it off, took inches off their waistlines and improved cholesterol problems.Add to that previous data that showed it helped smokers to quit and one could almost hear bells ringing to herald the arrival of a modern miracle.But reaction from doctors attending the presentation of the data at the American Heart Association scientific meeting on Tuesday ran the gamut from raves and cautious optimism to virtual rejection.”It seems to be the magical cure and may stand the test of time but it’s a little too early to predict how it goes,” said Dr. Porur Somasundaram of the University of Minnesota.Dr. Marrick Kukin, a cardiologist from St Luke’s-Roosevelt Hospital in New York, was clearly impressed by the sustained weight loss over a two-year period.”This is a unique drug, a combination of a lifestyle drug that also has medical necessity in terms of improving overall health,” he said after getting his first briefing on the drug.”My gut as a consumer is that this is going to be bigger than any lifestyle drug,” Kukin said. “Demand is going to be driven by both the patients who want it and doctors who feel it’s important for the patients to lose weight. The medical necessity distinguishes it from a drug like Viagra.”But Dr. Michael Crawford, professor of medicine at the University of California-San Francisco, was quick to pour cold water on the Sanofi celebration, injecting a note of fear into the proceedings.”Look what happened with fen-phen. The doctors got sued, the drug company got sued. Nobody’s going to touch this drug without long-term safety results,” said Crawford, adding that he would need to see at least five years worth of safety data before considering prescribing Acomplia.Drugmaker Wyeth has taken more than $16 billion in charges to cover liability to 6 million Americans who took its two “fen-phen” diet drugs that were withdrawn in 1997 after being linked to heart valve damage. The litigation it has spurred shows no end in sight.”Doctors are very gun shy now and unless (U.S. President) Bush reels in the trial lawyers, doctors are just not going to go there again without long-term safety results,” Crawford said.Dr. Joseph Hayes of Weill-Cornell Medical College in New York was also looking for a lot more testing and said a follow-up drug may yet be needed as weight loss leveled off after the first year of the study.He said the human body is not easily fooled long term, but he was impressed with the way the drug appears to work. “For some reason the desire to just eat, eat, eat just gets turned off. I don’t understand that, but if it works, that’s great.” (Source: Reuters, Nov 2004)