FEDS REBUFF 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.