Plebesite

Cannabis, by any name, has more than one active ingredient. It contains some 66 unique compounds ("cannabinoids"), at least six of which are biologically active, as well as compounds found in other plants that also exert effects (notably terpenes). In Cannabis bred for psychoactivity, the predominant active ingredient is delta-9 tetrahydrocannabinol (THC). Another component, cannabidiol (CBD), appears to exert analgesic effects without psychoactivity. Yet another, THC-V, appears to counter the effects of THC itself. A plant strain high in THC-V might yield a natural alternative to Acomplia.

One can't pin the gaffe-laden sentence on the reporter, Jeanne Whalen; seven or eight editorial types would have reviewed and/or revised her draft, including the bureau chief in London, several sub-editors in New York, a copy editor and a top editor with his/her name on the masthead. One of them well may have introduced the errors. (A good editor is a Godsend but some of them make changes like male dogs pissing, just to show they were there.)

Whalen recounts a three-year history of optimistic projections from Sanofi execs followed by FDA requests for more data. Sanofi originally asked the FDA to approve Acomplia for obesity (decision deferred), then sought approval for smoking cessation (denied). The company -the third biggest in the world- is currently touting the apparent success of Acomplia in raising good-cholesterol levels. Whalen quotes CEO Gérard Le Fur: "If we were to start again, we would say it's an antidiabetic agent."

The journal didn't deign to run a correction from California Cannabis consultant Philip A. Denney, MD, who wrote, "The endocannabinoid system that Acomplia is designed to block has been preserved in evolution for more than five hundred million years. Our understanding of this system is limited. Physicians in California who are monitoring cannabis use by hundreds of thousands of patients are concerned that blocking the endocannabinoid system may lead to as yet unrecognized untoward effects."

Dr. Denney saw his first Acomplia user two weeks ago in Redding. He expects many more in the days ahead because Sanofi is conducting clinical trials in the U.S. and individuals are ordering Acomplia from British pharmacies over the Internet. Denney says his Patient A has lost weight and reports no adverse effects. Doctors in the Society of Cannabis Clinicians plan to pool their data regarding patients who go on Acomplia, and to report their findings in due course.

Living Well Is the Best...

Why has an FDA panel of experts approved a drug called "Provenge" on the basis of two studies in which the drug did not meet its primary or secondary goals? Because "ITAL one type of analysis conducted in one of the studies END ITAL showed that patients receiving Provenge lived on average about four months longer than cancer patients not receiving the drug," according to the WSJ March 28. Researchers found that the stroke rate among Provenge takers was 3.9% compared with a 2.6% rate among those on placebo. Provenge was also found to cause fevers, chills and fatigue. Good name, though, with overtones of Provence and revenge... Imagine if some studies showed that cannabis use increased the rate of strokes 150%! Would there even be a debate about allowing medical use?

Whether or not a given synthetic potion will exert medical benefit is such a crap-shoot that it frequently happens that a clinical trial, while revealing a lack of efficacy in treating the condition for which the drug was developed, suggests efficacy in treating some other condition. "Studies of two heart drugs that failed to achieve their primary goals yielded some encouraging results in more-detailed analyses," according to another March 28 Journal story. An anti-inflammatory drug called succinobucol, developed by AtheroGenics, Inc. as an adjunctive medicine for heart-attack patients, didn't reduce the severity of symptoms or the death rate in a large trial. But -and this is the line the Journal editors chose to make their call-out quote- "During a two-year follow-up, fewer patients taking succinobucol developed new cases of diabetes." Too bad that "the drug was also associated with trends toward higher hospital admissions for heart failure, unfavorable changes in cholesterol levels and possibly an increase in procedures to re-open clogged arteries. One of the 2,233 patients on the drug suffered liver failure, and recovered when the drug was stopped."

Similarly, "Researchers said the angina drug ranolazine, marketed as Ranexa by CV Therapeutics, Inc., didn't show a benefit in reducing deaths and heart attacks in patients with unstable chest pain. But a 6,560-patient study didn't show evidence of heartbeat irregularities, a long-standing safety concern for the pill, and may actually reduce them. 'Ranolazine was not a disease-modifying therapy in this study,' said David Morrow, lead author, 'but we have absolute confidence in the safety results.'" Translation: it may not be good for you, but it won't hurt you and it helps some people, so why not try it? CV Pharmacueticals will now ask the FDA for approval to market Ranexa as a first-line angina treatment. Shares rose 18% on the happy prospect.