Two significant errors in one sentence marred a front-page story in the Wall St. Journal March 29 about the FDA’s looming decision on Acomplia, a drug manufactured by Sanofi-Aventis. Acomplia reduces appetite by blocking one of the body’s own cannabinoid receptors. The doubly erroneous sentence began: “Cannabis, the active ingredient in marijuana, acts on the same receptors”
“Cannabis” and “marijuana” are names of the same plant, which is also known as “hemp” (especially when grown for fiber from the stalk or oil from the seeds). Cannabis, the Latin name, was used widely by doctors who prescribed and drug companies that marketed herbal extracts in the U.S. in the late 19th and early 20th century. “Marijuana” is the colloquial term used by Hispanics in the southwestern U.S. who smoked it and were the primary targets of state and local prohibition laws. The Hearst press and the federal Bureau of Narcotics employed the Hispanic term, spelling it “marihuana.” During the House Ways and Means Committee debate on marihuana prohibition in 1937, several representatives and witnesses expressed confusion over the terminology, observing that cannabis and hemp were being used in medicine and industry.
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 blatant gaffe(s) on the reporter, Jeanne Whalen.* Seven or eight editorial types would have reviewed her story, 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 error. A good editor is a Godsend but some of them make changes like male dogs pissing, just to show they were there.
Acomplia has been approved for sale in England and most of Europe but not in the U.S. -yet. An FDA advisory panel will meet in June to review again its benefits and risks.
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.
The Shelley Mandel Principle
In the early 1970s a young clerical worker named Shelley Mandel sued to make Yom Kippur, the Jewish day of atonement, a paid holiday for California state, county and municipal employees. Her lawyers argued that Catholics got paid when they took off Good Friday, and Jewish employees deserved equal treatment. An Alameda County Superior Court Judge said he agreed with their premise and ruled that henceforth Good Friday would not be a paid holiday.
The Shelley Mandel principle should be borne in mind whenever reformers point out disparities within the law. In recent years some “movement” honchos have made much of the fact that sentences for possession of cocaine in its rock form (favored by black folks) are five times harsher than sentences for possession of cocaine in powder form (favored by whites). Sen. Elizabeth Dole has proposed ending the disparity by legislating harsher penalties for cocaine powder Activists ignore the Shelley Mandel principle every time they whine, “The federal government should be devoting its resources to the war on terror, not prosecuting poor, sick marijuana users.” They of all people should realize that the war on terror is as inherently phony -terrorism being a tactic- as the war on drugs.
Her name was Shelly Mandel, her age was twenty-three
A clerk typist working for the state
In Alameda County Department of Health
A hundred a week was her fate
And God forbid some morning she comes late
Now early in the fall comes the day the Jews atone,
The high Holy Day, Yom Kippur
And Shelly observed it in her own way at home
Till by evening she felt more secure
(and since everything’s relative, pure)
But Shelly wondered why should the state dock a Jew
When taking off Good Friday is okay
But Reagan just shrugged: getting pushy, aren’t you?
You’re gonna have to sue for your pay
Go away, little girl, go away
Two lawyers were found, they sounded real smart
A credit to Shelly’s own race
And Judge Robert Bostick also looked the part
A Superior smirk on his face
As he handed down his ruling in the case
All should get paid the same holidays
Good Friday the gentiles get none
And the lawyers smiled like they’d just gotten praised
And announced to the press they had won
What a wonderful job we have done!
But Shely Mandel is out a day’s pay
And many thousands more are deprived
Justice hasn’t changed much since Good Friday
And we all know how Jesus survived
While the judges and lawyers have thrived
When you go to court you should know the deck is stacked
They’ll uphold the hundred-dollar week
And if we ever want to get Shelly’s twenty back
We’ll have to find a better technique
And you all know of what I don’t speak
*One can. After sending this piece to Counterpunch, I sent a note to the Journal editor who handles corrections and got this in return from Whalen: “Thanks for writing — always good to hear from readers. I actually didn’t mean to get that technical in my phrasing — I was really just saying that the drug marijuana is made from cannabis. But thank you for the points you made.”
FRED GARDNER edits O’Shaughnessy’s, the Journal of Cannabis in Clinical Practice (soon to have a presence on the web). He can be reached at firstname.lastname@example.org