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Is GW Getting the Runaround?

by FRED GARDNER

GW Pharmaceuticals reported a favorable result last week in a phase 3 trial of Sativex involving 177 patients with severe cancer pain who were not getting adequate relief from opiates. Sativex is a cannabis-plant extract containing approximately equal concentrations of THC and CBD (cannabidiol). Patients in the study continued taking morphine and added either Sativex, a placebo, or another plant extract high in THC (all sprayed into the mouth). Some 40% of the patients taking Sativex reported pain reduction of 30% or more -significantly more relief than the placebo or the high-THC extract provided. The oft-repeated myth that Marinol (synthetic THC) contains the active ingredient of marijuana is dispelled by this and other studies showing that CBD plays a beneficial role. GW’s application to market Sativex has been denied, to date, by the Medicines and Healthcare products Regulatory Agency (MHRA, the British equivalent of the FDA). GW submitted data from clinical trials showing that Sativex reduced spasticity, but in December ’04 the Committee on Safety of Medicines (CSM), an advisory body to the MHRA, questioned the “clinical relevance” of the reduced spasticity (its meaning to the patients, a fuzzy concept) and required a confirmatory study.

GW is carrying out the extra study and also appealing the denial to the Medicines Commission, the senior advisory body to the MHRA. Several of the doctors who conducted the trials have expressed dismay towards the CSM. Professor Derick Wade, Professor in Neurological Rehabilitation, University of Oxford, and clinical expert on MS for the National Institute of Clinical Excellence National Clinical Guideline on management of MS, said, “I have treated more than 60 patients in clinical trials with Sativex. We have seen improvements in spasticity, and in other symptoms, usually sustained for many months. For patients, relief of spasticity is, like relief of pain, a substantial benefit in its own right. Many of those involved in the studies had already tried all other available treatments and so I believe Sativex is a valuable treatment option for people with MS whose spasticity is not yet adequately controlled.”

Is GW Pharmaceutical getting the kind of runaround from British regulatory authorities that Americans interested in cannabis-based medicine get from NIDA, the DEA and HHS? Geoffrey Guy remarked our astonishment back in ’98 when he said he’d been granted a license by the Home Office to grow cannabis, develop extracts with different cannabinoid ratios, and test them in clinical trials. The British government would treat him fairly, he reassured us. He had no doubt about it. There were hoops that had to be jumped through -purity, consistency, etc.- but he was a successful pharmaceutical entrepreneur and it was all do-able.

With every passing day that GW fails to get approval to market Sativex, our old cynicism towards the British government is restored. Recently it was revealed that an influential psychiatrist named Stuart Montgomery, a member of the Committee on Safety of Medicines, had advised Pfizer how to rewrite their application for Zoloft and held off becoming a paid consultant until after the approval had gone through (so he wouldn’t be disqualified). The more power Pfizer et al have over the regulators, the longer the runaround for GW.

She Was Hip All Along

The actress who played the pot-dealing seductress in Reefer Madness, Thelma White died last week in Los Angeles at the age of 94. She recognized the falseness of the film in front and didn’t want to appear in it, but the studio owned her. Her AP obit was poignant and informative.

“Ms. White played a hard-boiled blonde named Mae who peddles ‘demon weed’ to unsuspecting young people in ‘Reefer Madness,’ a low-budget cautionary tale written by a religious group. In the film, she lures high school students to her apartment for sex and drugs, turning them into addicts who shoot their girlfriends, run over pedestrians and go insane.

“A musical and comedy actress who made more than 40 movies, Ms. White was horrified when RKO Studios picked her for the antidrug film. But because of her contract, she had little choice but to accept the role.

” ‘I’m ashamed to say that it’s the only one of my films that’s become a classic,’ she told The Los Angeles Times in an interview in 1987. ‘I hide my head when I think about it.’

“Born Thelma Wolpa in Lincoln, Neb., in 1910, Ms. White was a carnival performer as a toddler before moving on to vaudeville, radio and movies.

” ‘Reefer Madness'” was destined for obscurity, but in 1972, Keith Stroup, founder of the National Organization for Reform of Marijuana Laws, discovered it in the Library of Congress archives, bought a print and screened it at a New York benefit.

“Robert Shaye, founder of New Line Cinema, saw the film and recognized its appeal as an unintentional parody. He re-released it through his then-fledgling company, holding midnight showings.

“Ms. White twice saw an off-Broadway musical that spoofed the movie. The musical ‘was campy and over the top, and she loved it,'” according to her godson, her sole survivor.

I didn’t know that Keith Stroup rediscovered Reefer Madness, and that it helped transform New Line Cinema (from a small company that booked speakers for college events) into a major movie distributor. Nor did I know that a religious group wrote the inane flick; the credits name two Hollywood professionals who mostly turned out B- westerns.

According to Kevin Murphy and Dan Studney, authors of the latter-day musical that Ms White enjoyed, “Reefer Madness began its cinematic life as a 1936 cautionary film entitled ‘Tell Your Children.’ It was financed by a small church group, and was intended to scare the living bejeezus out of every parent who viewed it. Soon after the film was shot, however, it was purchased by the notorious exploitation film maestro Dwain Esper (Narcotic, Marihuana, Maniac), who took the liberty of cutting in salacious insert shots and slapping on the sexier title of Reefer Madness, before distributing it on the exploitation circuit. Esper was an absolutely notorious figure who would do things like stealing unattended prints of studio films out of projection booths and film exchanges, and then physically drive them from small town exhibitor to small town exhibitor until the authorities caught up with him. A delightful, poignant and detailed portrayal of this lunatic opportunist is featured in exploiteer Dave Friedman’s autobiography, A Youth in Babylon, which is a book every cult movie or pop culture enthusiast ought to read.

“After a brief run, the film lay forgotten for several decades. There was no concept of after market in those days, especially for films that existed outside the confines of the studio system. For this reason, neither Esper nor the original filmmakers bothered to copyright the movie, and it eventually fell into the public domain.”

Murphy and Studney got their info mainly from White herself and documentary maker Ray Greene, whose films include “Schlock!”

We have yet to identify the “small church group” that financed “Tell Your Children.” Pothead lore has it that Reefer Madness was made in concert with a campaign to impose federal marijuana prohibition led by Harry Anslinger, the commissioner of the Bureau of Narcotics, who manipulated the media and understood the influence of Hollywood. The “Reefer Madness” line jibes perfectly with Anslinger’s. “Marijuana is an addictive drug which produces in its users insanity, criminality, and death,” he told Congress in ’37. They believed him and we are still feeling the consequences.

There is a movie to be made about the making of Reefer Madness–a musical. Woody Harrelson, maybe, could play Anslinger (then about 40). But who could play alienated, musical Thelma White?

FRED GARDNER can be reached at journal@ccrmg.org FRED GARDNER can be reached at journal@ccrmg.org

Fred Gardner is the managing editor of O’Shaughnessy’s. He can be reached at fred@plebesite.com

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