McCaffrey Threatens Lockyer
With Arrest If California Does Research On Medical Marijuana,
But Says "A Massive Research Effort" Is Needed To See If Marijuana Has Any
Medical Value;
New Stalling Begins -- 3 Articles
(Marijuananews note: There has been no media
coverage of this, which is pretty typical. However, given the publicity surrounding the
IOM report it is surprising that none of the other California papers covered it. Even the
Bee buried it at the bottom of a story about a nuclear dump!The second story is an
excellent UPI feature "Feds Rebuff Medical Marijuana Researchers" that went on
the wires the week before the IOM report and was also generally ignored.
I had decided to hold it and see what kind of coverage it got and use it for just this
sort of occasion. It is not at all "news" to anyone familiar with the issue, but
it is definitely more relevant after the IOM than before.
It was predictable that the Czar and Janet Waco would simply use the IOM report as a new
excuse to stall on medical marijuana. When Lockyer announced that he and other Attorneys
General were going to meet with the head narcs about medical marijuana,
See
Attorneys General
From California And Other States With Medical Marijuana Laws
To Go To D.C. To Urge Rescheduling Of Cannabis
I said that "Lockyer is a Democrat and Al Gore has to carry
California, so the Administration cannot be seen to dismiss him out of hand. They will
have to lie and stall, but they are very good at that. However, Lockyer is learning and is
getting a better understanding of the games that narcs play."
Well, I was wrong. They not only dismissed him out of hand, they even threatened to
take him in hand, if he actually interfered with their stall.
The suppression of medical marijuana remains the highest priority and the state
ideology of the DEAland government. The IOM report was a media disaster for them but with
a lovely little foreign war to distract us from the ugly big domestic war, it is business
as usual.
See
Prohibitionist
Editorial Page Of The Tennessean
Typical Of Defectors Now Supporting Medical Marijuana:
"The federal government shouldn’t hamper states that want to allow pot by
prescription
for chronically ill patients. Any other course is cruel."
The degree of cynicism that is required to do this after the IOM
report and in the face of overwhelming public opinion is breathtaking.
The third piece is a short message from Rick Doblin, who is very knowledgeable about the
Fed's "research game."
In any case, this intransigence makes the Class Action lawsuit
See
Plaintiffs In Class
Action File Motion To Reconsider
The Fundamental Constitutional Rights Basis For Case
and Jon Gettman’s rescheduling suit all the more important.
See
How The IOM Report
Impacts The Move To Have Medical Marijuana Rescheduled )
LOCKYER: U.S. WILL END PUSH FOR NUKE DUMP AT DESERT SITE
March 27, 1999
From The Sacramento Bee
http://www.sacbee.com
By Stephen Green, Bee Capitol Bureau
(Marijuananews note: This is an excerpt from a much longer
article. This was at the end.)
Lockyer also met in Washington with U.S. Attorney General Janet Reno and White House
drug czar Barry R. McCaffrey, to discuss California’s Proposition 215, which
legalized marijuana for medical uses.
"Both were very clear that medical marijuana use violates federal law,"
Lockyer said, and McCaffrey added that a massive research effort is
needed to determine if marijuana has any medical value.
Lockyer said he told McCaffrey that state law authorizes him to conduct certain
marijuana-related research. But McCaffrey told Lockyer he’d be violating federal
law and risking arrest if he did so.
In the short term, Lockyer said, there will be no change in
federal policy and California’s law should be improved so solid statutes are
in place if and when the federal government recognizes it.
FEDS REBUFF MEDICAL MARIJUANA RESEARCHERS
March 10, 1999
From United Press International
http://www.sciencenews.org/sn_forms/sn_ctact.htm
By Ellen Beck
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.
See
Government Health
Officials Deny Marijuana and Pain Study, Again -- NORML Press Release
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.
From Rick Doblin, RickMAPS@aol.com
MAPS President owner-maps-forum@maps.org
March 23, 1998
(Marijuananews note: Rick is also a member of the NORML board of
directors.)
I was at FDA headquarters last Thursday, March 18, 1999, complaining to the FDA
ombudsman and to a senior FDA official that FDA was blocking medical marijuana research by
refusing to review protocols until NIDA agreed to provide the marijuana. This policy
forced all potential marijuana researchers to submit protocols to NIH for federal funding,
a review guaranteed to delay research and almost certain to result in rejection.
The MAPS-supported efforts of Dr. Donald Abrams, UC San Francisco, are the only
exception I know of.
(Marijuananews note: This was delayed for five years before bad publicity finally
forced NIDA to stop playing games.)
The timing of my meeting with FDA officials couldn’t have been more fortuitous
since that very morning news of the IOM report and its recommendation that studies with
smoked marijuana be approved were all over the front pages of the Washington Post, NY
Times, USA Today, etc etc etc.
I argued that FDA should review protocols so we could get the benefit of FDA expertise
in protocol design, and that sponsors of non-federally funded projects deserved the
opportunity to try to convince NIDA that their studies were
"scientifically meritorius", the current phraseology used by Dr. Leshner to
describe his criteria for letting lose of his hold on NIDA’s monopoly supply of
marijuana for FDA-approved research. I think some headway was made and that the
policy will change.
See
The Scientist
Magazine Does A Reverent Interview with the Head of NIDA
Dr. Ethan Russo will test the waters in the next week or so with his MAPS-supported
protocol to study the use of smoked marijuana in the treatment of migraines, in order to
see if a new policy is really put in place. Dr. Russo’s protocol has been rejected by
NIH twice, the last time primarily because it was a controlled trial instead of simply a
preliminary study. Whether the policy does indeed shift will be an
important sign of whether the Clinton Administration is still obstructing medical
marijuana research while pretending to be in favor of research.
See above
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