Perhaps The Single Most
Damning Article On Medical Marijuana Fiasco I Have Ever Read
– Without Intending To Be
(Ed. note: While there are a few minor errors in
this article, it is an excellent overview of the current state of bureaucratic medicine. I
say that this is perhaps the single most damning look at the medical marijuana fiasco that
I have seen, precisely because it does not try to be. It does not argue for medical
marijuana or even seem to be aware of the significance of some of the points that it
makes:
- There is no doubt that marijuana has medical value.
- Many patients say that it works better than Marinol, so the makers of Marinol are trying
to find ways to better mimic marijuana.
- Many oncologists are afraid to prescribe even the legal Marinol and most don’t know
anything about it, or medical marijuana.
- The government makes it as difficult as possible to do research on marijuana.
- Medical marijuana is being held to a standard that does not apply to any other
pharmaceutical product.
- The researchers are operating in an ethical void. They express concerns about the
possible side-effects of marijuana, but not of the policies whose perversity they fully
describe. In short, the people to whom we are supposed to entrust our health are simply
not trustworthy.)
Oncology Times
May 1998
Volume XX No. 5 p. 75
oncologytimes@compuserve.com
By Peggy Eastman
NEW, IMPROVED MEDICAL MARIJUANA DRUG READIED FOR TESTING
Washington, DC - The company that makes Marinol - the only medicinal marijuana drug
approved in the US - hopes to be in Phase I clinical trials of a new pharmaceutical form
of marijuana by the second quarter of this year.
A new form of medicinal marijuana would be good news to the
patients who say they prefer smoked marijuana to relieve their medical ailments rather
than a pill. Some came here recently to the staid National Academy of Sciences
building for a scientific workshop on medical marijuana - several in wheelchairs with
companion dogs - to state their case. Except for eight patients
grandfathered under the federal government’s disbanded compassionate use program,
smoked marijuana is illegal in every state except California.
Delta-9-tetrahydrocannabinol (THC) is the most active ingredient of the marijuana plant
and the one believed to have medicinal value for patients with cancer, AIDS, glaucoma, and
a host of other illnesses and conditions.
(Ed. note: This ignores the research on other marijuana
ingredients.)
See
Could Medical
Marijuana Have Prevented Gulf War Syndrome? Derivative Combats Nerve Gas, Say Israeli
Reports
"We are keenly interested in a new formulation for THC," said Robert E. Dudley,
PhD, Senior Vice President of Unimed Pharmaceuticals, Inc., in Buffalo Grove, IL, speaking
here at the last of three information-gathering workshops sponsored by the Institute of
Medicine of the National Academy of Sciences. Marinol is taken orally in gel capsules.
(Ed. note: Unimed has lobbied against legalizing medical
marijuana, that is against the decriminalization of its prospective customers who might
choose to use whole cannabis instead of their product. The DEA is a part of their
marketing arm.)
Dr. Dudley said the company wants to more nearly mimic inhaled marijuana, avoid the
first pass through the liver that occurs with the oral formulation, and develop a
faster-acting THC product. Drug delivery routes under consideration are sublingual, nasal
aerosol, and pulmonary aerosol formulations.
See
Why would anyone
want to smoke a medicine? Isn't smoking per se bad for you?
Approved Form
Marinol was approved in 1985 as an antiemetic for cancer patients undergoing
chemotherapy, and in 1992 it was approved for treatment of anorexia associated with weight
loss in AIDS patients. Today, Dr. Dudley said in an interview, about
10 percent of Marinol sales are in oncology and about 90 percent in the HIV/AIDS treatment
field. Sales data, he said, are strictly a function of how Marinol is marketed.
Considering how much controversy swirls around providing marijuana to patients legally,
Dr. Dudley said, "I am always amazed when I meet physicians
who don’t know that an approved THC product has been on the market for 13
years." He added, "Oncologists don’t know much about it; many don’t
use it much. We need more awareness about Marinol among oncologists."
Dr. Dudley said he believes that the fact that Marinol is a controlled substance has
proved to be a hindrance to its acceptance by oncologists. In 1995 Unimed petitioned the
US Drug Enforcement Administration to change Marinol from a Schedule II to a Schedule III
drug, he said.
The company is awaiting a US Department of Health and Human Services review of that
petition and expects final US Drug Enforcement Administration action on its request this
year. Rescheduling, said Dr. Dudley, would provide for improved patient access to Marinol,
availability of prescription refills of the drug, increased pharmacy stocking, and a much
higher comfort level among physicians.
"A lot of physicians are leery of prescribing Schedule I and II drugs," said
Dr. Dudley. "They feel they’re being watched by the feds.
Schedule I and II drugs are viewed very differently from Schedule III drugs and
non-scheduled drugs." (Note by Tom Barrus, R.Ph., MBA - The DEA does not allow usual
prescribing of schedule I drugs. However, Dr. Dudley is correct about feeling that,
doctors who write prescriptions for schedule II drugs are being watched by the feds. The
DEA is watching them and counting the kinds and numbers of pills they prescribe.)
He said the company knows Marinol is expensive (about $200 a
month for the average patient who uses it), but that there is coverage of the drug
by third-party payors. The expense of the drug - along with the fact
that some patients say smoked marijuana is more effective for them - is one reason
consumer advocacy groups… believe patients who smoke marijuana for medicinal reasons
should be allowed to do so without risking breaking the law.
The Institute of Medicine investigators studying medicinal uses of marijuana will
produce a final report - expected to be finished by the end of this year - on the health
benefits and risks of the plant. One of the issues they are
examining is whether smoked marijuana is a "gateway drug" to other illegal
drugs.
"There is a tremendous amount of new science" on the medical benefits of
marijuana, said John A. Benson, Jr., MD, co-principal investigator of the Institute of
Medicine study and Emeritus Professor and Dean at Oregon Health Sciences University. "My hope is that we’ll go beyond asking for more research and
that we might offer some specific suggestions for research," said Dr. Benson.
In an interview, Dr. Benson added, "In general, patients
like the plant. They say, why bother [to do more research]? Or they say, ‘Let us use
the plant while you do your research.’ But that’s not up to Drs. Benson
and Watson." Dr. Benson’s co-principal investigator on the Institute of
Medicine’s marijuana study is Stanley J. Watson, Jr., MD, PhD, Co-Director and Senior
Research Scientist at the University of Michigan’s Mental Health Research Institute.
Difficult Drug to Study
The use of medical marijuana is so political and controversial that it has been hard to
subject it to rigorous scientific scrutiny. In August, the National Institutes of Health
released the report of a panel that met the previous February to review the scientific
data on the potential therapeutic benefits of marijuana and the need for, and feasibility
of, more research. The NIH panel concluded that the risks linked to marijuana, especially
smoked marijuana, must be considered not only in terms of immediate adverse effects on the
lung, but also in terms of long-lasting effects in patients with chronic diseases who
might use it for long periods of time.
The NIH panel felt that frequent and prolonged marijuana use might reduce immune
function (especially in patients with compromised immune systems); they were also
concerned about the dangerous combustion byproducts of smoked marijuana on patients with
chronic diseases. Thus they favored the development of a smoke-free inhaled delivery
system that could deliver purer forms of THC or related cannabinoid compounds.
See
Painkillers Put
Millions At Risk Of Ulcers; Hospitalize 76,000 & Kill 7,600 Annually; One That
Doesn’t Kill Is Illegal
and
Adverse
Pharmaceutical Reactions Major Cause of Death; Marijuana Does Not Kill But Must Be
Approved By FDA?
NIH Director Harold Varmus, MD, said the NIH is open to receiving research grant
applications for studies of the medical efficacy of marijuana, and will put applications
through "our normal scientific review."
The National Institute on Drug Abuse maintains a contract with the University of
Mississippi to grow marijuana for research purposes, according to Institute sources. The
Institute also has a contract with Research Triangle Institute to package the product into
cigarettes distributed for NIH-approved research to scientists who have an Investigational
New Drug clearance from the Food and Drug Administration. A small
portion of these cigarettes - which are made according to standardized specifications from
marijuana of known origin and quality - go to eight patients legally supplied with
marijuana under the government’s compassionate use program, which has been
discontinued.
At the Institute of Medicine workshop, speakers said marijuana’s
status as a controlled substance discourages scientists from attempting to study its
therapeutic benefits. There is a "tremendous bureaucratic tangle to get a protocol
approved," said J. Richard Crout, MD, a former FDA official who now runs Crout
Consulting. He said that in addition to the constraints of the Drug Enforcement
Administration, state agencies may also become involved in controlling marijuana trial
protocols.
Nevertheless, other speakers said studies of cannabinoids are
underway. David Pate, a senior technical officer with HortaPharm, BV, in Amsterdam, said
his company is manufacturing a generic THC drug and that he is studying another
cannabinoid-like drug that goes to the same receptor as THC.
Smokeless Cannabinoids
Phyllis I. Gardner, MD, a dean at Stanford University and a consultant to Alza
Corporation in Palo Alto, CA, said if she had a choice, she would
choose inhalation as her first choice of delivery because it seems to provide the most
therapeutic benefit. She said Alza tried to make a cannabinoid transdermal patch in
the 1970s, but "it didn’t work." She cited transmucosal delivery as a
promising route, noting that in general Americans accept nasal delivery but do not accept
rectal suppositories as readily as Europeans do.
Reid M. Rubsamen, MD, Vice President for Medical Affairs of Aradigm Corporation in
Hayward, CA, said he is working on a respiratory-tract drug delivery system for analgesics
in which the patient holds a device with a light that tells him how to breathe; a
liquid-formulated drug flows through the device in fine-particle, low-velocity aerosolized
form. With this system, he noted, more of a given drug goes into the alveoli.
Mahmoud A. ElSohly, PhD, President of ElSohly Laboratories, Inc., in Oxford, MS, said
he is studying delta-9-THC-hemisuccinate in suppository form as an alternative to oral and
smoked THC. He is testing this formulation on patients with spasticity, and said he was
"very encouraged" from preliminary results.
The Institute of Medicine carefully warned observers at the Washington workshop about
the dangers of drawing inferences too hastily about what may be in the final report on
medical use of marijuana. It stated that "observers who draw conclusions from the
workshop about the Institute of Medicine study, will be doing so prematurely. The goal of
this meeting is not to draw conclusions, but to listen to the evidence."
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