Dr. Donald Abrams Receives FDA Approval for First Human Vaporizer Research 12/5/03
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Multidisciplinary Association for Psychedelic Studies
FDA has approved Dr. Donald Abrams' study comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in human subjects who smoke marijuana and (at a different time) inhale vapors from the same amount of marijuana in the
Volcano vaporizer. This historic study will begin in early 2004.
The only remaining milestone that is required before it makes financial and political sense to initiate a major medical marijuana drug development effort is for NIDA's monopoly on the supply of marijuana that can be used in FDA-approved research to be broken. MAPS hopes to accomplish this by either obtaining a DEA license for the UMass Amherst project (most desirable) or by obtaining a DEA permit to import marijuana from the Dutch Office of Medicinal Cannabis (less desirable). DEA is still leisurely reviewing applications for both of these sources of supply.
Testing Marijuana as a Pain Reliever April 12, 2002
The study, led by Dr. Donald Abrams at the University of California-San Francisco, is under the aegis of the Center for Medicinal Cannabis Research. Unique in the country, the agency was established by a 1999 state law that provides $3 million a year for three years to research marijuana's potential as medicine.
Government Bias Prevents Gains in Cannabis Research June 12, 2002
Dr. Donald Abrams, a medical professor at the University of California at San Francisco, is a rarity -- a researcher who won approval to conduct a study with federal funds and marijuana.
Abrams wanted to study whether pot would help AIDS patients gain weight and reduce nausea. His test proposal was rejected twice before being approved in 1997. In part to improve his chances, Abrams rewrote his proposal to measure whether marijuana caused accepted AIDS medicines to be less effective.
"There are so many hoops and loops," Abrams said.
Some seriously ill people smoke marijuana illegally. But Irvin Rosenfeld, 49, a stockbroker near Fort Lauderdale, Fla., is one of seven patients who smoke with permission from the U.S. government.
Rosenfeld is a holdover from a now-abandoned "compassionate investigational new drug" program that let about three dozen chronically ill patients smoke marijuana to relieve symptoms. The program ended under President George H.W. Bush, but Rosenfeld was "grandfathered in" and now smokes 12 marijuana cigarettes a day.
Rosenfeld, who has more than 200 bone tumors from a rare disease, said his doctor makes annual progress reports to federal officials. The marijuana dulls his pain, relaxes muscles and reduces inflammation, he said.
"Each year my doctor filled out elaborate forms," Rosenfeld said. "The first time it took three hours. Three months later he asked, `What does the government think about that report?' I said, `What are you talking about? They buried it.' The next year, he took a red magic marker and put on each page: `It's Working.' We never heard back."
Rosenfeld and three other program leftovers were recently studied by Dr. Ethan Russo, a Missoula, Mont., neurologist who concluded their pain relief and other benefits outweighed any cognitive or other impacts from smoking.
Before that analysis, Russo said, he had twice been denied federal funding for a study on how marijuana might dull migraine headaches.
"If I would have started out with a premise that cannabis causes headaches rather than relieves them, I not only could have gotten approval for the study, but I bet I would have gotten funding," Russo said.
Calif, US Medical Marijuana Laws Clash June 06, 2002
"Antiretroviral therapy was directly observed. Subjects did not miss a dose," said Dr. Donald Abrams, the lead author of the study that was presented July 13, 2000, at the XIII International AIDS Conference in South Africa.
While marijuana is considered easy to get in just about any U.S. city, medical marijuana users, many of whom are in poor health, say they need a "safe" and easily accessible place where they can obtain marijuana without having to do their deals on the street where they risk getting beaten up, robbed or arrested.
Bush plans to screen whole US population for mental illness
by Jeanne Lenzer New York
A sweeping mental health initiative will be unveiled by President George W Bush in July. The plan promises to integrate mentally ill patients fully into the community by providing "services in the community, rather than institutions," according to a March 2004 progress report entitled
New Freedom Initiative While some praise the plan's goals, others say it protects the profits of drug companies at the expense of the public.
The Madness of King George
In The Madness of King George: The Ingenious Insanity of Our Most "Misunderestimat ed" President the authors ponder the burning question of the day- at times like these... what did we do to deserve a leader like this?
The Progress Report
Donate to Bu$h--Or Else, Drug Companies Told Staff
During the 2000 presidential campaign in the US, executives at Bristol-Myers Squibb, one of America's largest drug companies, received an urgent message: Donate money to George Bush. The message said they were told to donate the maximum - $1000 in their own name and $1000 in their spouse's - and if they failed to do so, their names would be forwarded to the company's then chief executive, Charles Heimbold.
Eli Lilly, Zyprexa, & the Bush Family by Bruce Levine
More than one journalist has uncovered corrupt connections between the Bush Family, psychiatry, and Eli Lilly & Company, the giant pharmaceutical corporation. While previous Lillygates have been more colorful, Lilly’s soaking state Medicaid programs with Zyprexa—its blockbuster, antipsychotic drug—may pack the greatest financial wallop. Worldwide in 2003, Zyprexa grossed $4.28 billion, accounting for slightly more than one-third of Lilly’s total sales. In the United States in 2003, Zyprexa grossed $2.63 billion, 70 percent of that attributable to government agencies, mostly Medicaid.
At the same time regulatory agencies were warning of Zyprexa’s possible linkage to diabetes, Lilly’s second most lucrative product line was its diabetes treatment drugs (including Actos, Humulin, and Humalog), which collectively grossed $2.51 billion in 2003. Lilly’s profits on diabetes drugs and the possible linkage between diabetes and Zyprexa is not, however, the most recent Lillygate that Gardiner Harris broke about Zyprexa in the New York Times on December 18, 2003.
Hemp World
FDA's counsel accused of being too close to drug industry
Daniel Troy, chief counsel to the US Food and Drug Administration, is under fire for inviting drug companies to inform him of lawsuits against them so the FDA could help in their defence. "We can't afford to get involved in every case—we have to pick our shots," he said, advising them therefore to "make it sound like a Hollywood pitch."
Congressman Maurice Hinchey of New York charges Mr Troy with a "pattern of collusion" with drug and medical device manufacturers. Mr Hinchey told the BMJ that the FDA had "corrupted its mission to protect the public health" and that Mr Troy "is aggressively intervening against the public on behalf of drug companies and medical device manufacturers."
Mr Troy's supporters insist that it has been necessary for him to involve himself in court cases to protect the interests of the FDA. The agency says that court plaintiffs are intruding more heavily
Whistleblower charges medical oversight bureau with corruption
Whistleblower removed from job for talking to the press
US bill to shield drug companies from product liability