Almost exactly two years ago, researchers were excitedly telling the American College of Cardiology's annual scientific meeting that a new drug, Acomplia (rimonabant), "doubled the odds of quitting smoking" while markedly reducing the weight gain that often accompanies giving up cigarettes.

Presenting results from a study that drug developer Sanofi billed as "one of the largest smoking cessation trials ever conducted in the United States," Dr. Robert Anthenelli of the University of Cincinnati, one of the lead researchers, said: "This may be a major step forward in smoking cessation."

In addition to the STRATUS-US trial (STudies with Rimonabant And Tobacco USe) producing these exciting results, the world was told to expect more news from two additional smoking cessation trials, STRATUS-EU and STRATUS-WW.

"STRATUS-EU is being conducted in 32 sites throughout Europe and has an identical protocol to STRATUS-US," Sanofi announced at the conference. "STRATUS-WW is a one-year maintenance study currently underway in 54 sites worldwide. Results for STRATUS-EU and STRATUS-WW are expected in the next 12 months."

Well, the twelve months came and went. As we approached the end of a second year, and heard nothing about these trials from Sanofi, we asked Dr. Anthenelli what he knew of the other smoking trials. He responded that he was not a researcher on these trials, and forwarded our email to Sanofi.

On Jan. 18th of this year, Sanofi spokeswoman Julissa Viana emailed us saying: "We have a publication plan in place and publications are expected shortly."

Well, we not only haven't heard anything further, but on Feb. 17th, the U.S. Food and Drug Administration notified Sanofi-Aventis that its much anticipated drug Acomplia (rimonabant) is "not approvable" as an aid for smoking cessation.

And, Sanofi now reveals, the FDA has told it that if the company continues to want to seek approval of Acomplia as an aid to smoking cessation, it must conduct another study (presumably in addition to the two trials that seem to have been flushed).

So, independent researchers wonder, what's the story with the two studies that Sanofi seems to want to disappear.

Were they far less encouraging than the STRATUS-US trial? Did the trials raise safety issues that thus far have not been disclosed?

Sanofi management, in its meeting with analysts on February 24th, refused to answer a question related to the FDA's action in rejecting Acomplia for smoking cessation in the same way it stonewalled on the outstanding issues the regulatory agency wants addressed before consideration of Acomplia for weight-loss.

"One more time, really sorry, but let us work and discuss with the FDA," said Sanofi Senior Executive Vice President Gerard Le Fur. " We do not want to comment more on rimonabant. We mentioned to you in the (FDA) letter we were asked to perform a new trial (for smoking cessation). We do not want to comment more."

Well, before a new trial gets started, maybe someone should insist on knowing more about the results of the two completed trials.