Pubdate: Fri, 12 Mar 1999 Source: United Press International Copyright: 1999 United Press International Feedback: http://www.sciencenews.org/sn_forms/sn_ctact.htm Author: Ellen Beck FEDS REBUFF MEDICAL MARIJUANA RESEARCHERS WASHINGTON, March 10 (UPI) -- Researchers who want to conduct clinical trials on the efficacy of medical marijuana say while the government publicly invites such studies, privately it works to quash the proposals. Ultimately, the researchers tell United Press International, the federal government works to end the move to legalize the drug as a treatment for seriously ill patients. The debate is whether the scientific evidence is strong enough to warrant the federal government reclassifying the drug from Schedule I and prohibited in all uses, to Schedule II, where, like cocaine, it would be approved for a select number of medical applications. The Clinton administration and the Department of Justice oppose the reclassification, pending more clinical trial evidence of efficacy. "There have been no government funded studies of marijuana's medical utility in more than a decade," wrote Drs. Lynn Zimmer and John Morgan in their 1997 book, "Marijuana Myths, Marijuana Facts." They said the battle is political, not medical, and cited a number of anti-drug organizations as saying it would send the wrong message to teenagers. Next Wednesday, the Institute of Medicine will release an 18-month, $1 million government-funded report on current scientific evidence regarding medical uses for marijuana. A 1982 IOM report had looked at the whole issue of marijuana and its effects. The latest report was requested by federal drug czar Barry McCaffrey in 1997 after the 1996 elections in which Arizona and California passed laws legalizing the medical use of marijuana. Currently, a number of western states have similar laws legalizing smoked marijuana when prescribed by a physician for a few select illnesses, such as nausea from cancer chemotherapy, glaucoma, seizures/spasms, chronic pain and AIDS. Physician researchers like Dr. Ethan Russo, of the Western Montana Clinic in Missoula, Mont., say while the government publicly encourages clinical trials, its agencies, such as the National Institutes of Health, the National Institute of Drug Abuse and the Food and Drug Administration, find ways to make sure studies don't happen. "It's very easy for his (Clinton's) hench people, (Health and Humans Services Secretary Donna) Shalala and McCaffrey to do his bidding and see that nothing happens," Russo said. Of the government agencies involved, including NIDA, HHS, NIH and FDA, only NIH agreed to an interview. The spokesperson declined to comment on specific grant applications, saying NIH considers it privileged information. The spokesperson said NIH is open to medical research projects which are "well designed clinical trials" that can "go through the peer review process." Dr. Paul Consroe, of the Health Sciences Center at the University of Arizona, has been involved with marijuana research since 1971 and is collaborating on a study to evaluate the effects of the whole cannabis plant in stimulating appetite and weight gain in cancer and AIDS patients. He said he was lukewarm about getting involved in getting NIH approval. "I don't like to butt my head up against a wall," Consroe said. "I'm tired of this. I just want out." His colleagues include Dr. Robert Gorter, a well-known oncologist from Berlin who played a major role in the successful effort to get Marinol, the pill version of the active ingredient in marijuana, FDA approved for use in cancer and AIDS. In September 1997 the FDA gave Consroe and colleagues oral approval for a phase three clinical trial of 360 AIDS patients and 360 cancer patients. In February 1998, a new chair of the same FDA panel reversed the decision, saying the group had to go back and do phase one trials first. In March 1998, during a conference call with the FDA, Consroe said they were told they could combine phase one and two trials. In October 1998, the FDA sent a letter saying the clinical trials had been put on hold. Meanwhile, their grant application to NIH for a phase three trial ended up at the National Cancer Institute, which nixed it. All three physicians met with the FDA in Washington but Consroe said they didn't get any answers, other than being told, "Since you're trying to market, you've got to be treated like everyone else." Finally, the FDA's most recent communication on the matter is that the group could do a small phase one study in six people while at the same time gathering data on animal studies for FDA review. Russo twice applied to the NIH for permission to conduct a clinical trial on the use of smoked marijuana by migraine sufferers and was refused. NIH said his application relied on anecdotal evidence and lacked scientific data, even though the second one was tailored to meet the recommendations given after the first refusal. He said repeated requests for "dialogue" with the NIH went unanswered. He argued history is replete with evidence marijuana has been used to treat migraines for 1,100 years and was a mainstream treatment in the Untied States in the mid-1800s. Russo said as was his right by NIH rules, he requested the NIH panel reviewing his application include neurologists, but it did not. "It was mostly psychiatrists on the panel," he said. "They're not experts in migraines. The objections they were raising, the complaints they had, portrayed an ignorance of the issue. The desk was stacked, despite my requests for a certain composition." NIH critics charge the rules of the game are different for medical marijuana studies. They contend unlike with other drug applications, the government requires all medical marijuana clinical trials be funded by NIH. The only legal source for getting marijuana to use in clinical trials is the NIDA, which Russo said advised him in one letter that he could get the drug only with NIH approval and in another that it would fund a qualified study without NIH approval. "This is unheard of, a punitive requirement," Consroe said. "No other drug in the world is subject to that, that I know of. If I had my own money, and by the way we do have our own money (for research), we couldn't get the drug in the U.S." The NIH spokesperson said she was not aware that NIH had such a requirement. In October 1997, NIH awarded a $1 million grant to Dr. Donald Abrams of the University of California-San Francisco to conduct a two-year safety study, including 63 patients, of smoked marijuana versus Marinol. However, when Abrams originally went to NIH in 1992 it was for funding for a much different study, to compare the effects of smoked marijuana, a placebo and oral Marinol in HIV-positive male patients. That request was turned down by NIDA twice. Consroe and others say the government's slant is toward research that will discredit the medical use of marijuana and even though Abrams had FDA approval for his initial study, it was only when he changed his protocol toward a safety study aimed at the toxicology issues, did he win NIDA approval to receive the drug. In 1997, a NIH panel looked at medical marijuana and determined there was not enough scientific evidence on it. The NIH spokesperson said at that time there was substantial media coverage of the NIH's request for grant proposals for clinical trials. Since then, the NIH has received several applications which the spokesperson said are now in the review process. In a 1997 fact sheet on medical marijuana, the NIH said such research poses some challenges. It said the studies need to objectively measure a positive therapeutic effect which would be difficult in a blind study in which neither the doctor or patient knows which drug is being used. Other concerns included the side effects of smoking itself. - --- MAP posted-by: Patrick Henry