US: Feds Rebuff Medical Marijuana Researchers



Pubdate: Fri, 12 Mar 1999 



Source: United Press International 



Author: Ellen Beck 	



ubject: 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.