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.