Summer 2003
O'Shaughnessy's
Journal of the California Cannabis Research Medical
Group
|
CMA, Patients Join Push for
Guidelines
The California Medical Association wants the state Medical Board to adopt practice
guidelines for doctors who approve cannabis use by their patients.
So do the approximately 15 doctors who have made a subspecialty of monitoring
their patients’ cannabis use.
And so do the patients themselves.
Suggestions, requests and urgent pleas from these sources have been expressed
to the Board at recent meetings.
Attorney Alice Mead set forth the CMA position at the Jan. 31 meeting of the
Board’s Medical Quality Division.
Then, at the CMA’s 2003 convention, held in San Francisco in late March, a
proposal for specific “minimum practice standards” was introduced by Tod Mikuriya,
MD and supported by Frank Lucido, MD. The key points:
“1. The initial examination is face-to-face, in person, confidential, and live.
(Periodic follow-up may be via video, photographic, telephonic, or email means.)
“2. The examination is memorialized with elements of the patient’s name, sex,
birthdate, address, phone number, date of examination, and coded diagnoses.
“3. There is documentation supporting the diagnoses.”
Mikuriya had proposed a second resolution: “That CMA urge the Medical Board
of California to cease harassing physicians and comply with the recent federal
injunctive decision protecting physicians who recommend and approve medical
marijuana…”
The reference to harassment drew a sharp retort from Ronald L. Morton, MD,
a CMA delegate who also serves on the Medical Board.
“I disagree with resolution two because it is not factually accurate,” said Morton. “I
sit on the MQ [Medical Quality] panel and I read the cases that come across.
Some examples, rather than persecution, represent people that are offering no
examination, have no e-quipment —just a receipt book— and are charging $250 for
a recom-mendation. I don’t think that’s what we think is good medicine.”
Morton explicitly supported the call for mini-mum practice standards. “I agree
with resolution one. I think it is helpful to set standards.”
San Francisco physician Bob Gould introduced an amendment to Mikuriya’s resolutions
which the Reference Committee passed. It read: “Resolved: that the CMA urge
the Medical Board to revise its guidelines regarding medical marijuana so that
the guidelines include the requirements for a good faith exam with diagnosis,
treatment and follow-up recommendations, and more fully clarify and affirm
the legitimate role of physicians in recommending marijuana to appropriate
patients,
“And be it further resolved: that the CMA urge the Medical Board to apply clinically
appropriate standards of care to all physicians, and not to apply a higher standard
of care or to require a higher degree of evidence in cases where medical marijuana
is involved.”
This version passed the full House of Delegates on the “consent calendar” (meaning
the reference committee didn’t consider it controversial enough to warrant
further discussion).
Although it wasn’t the clear-cut set of standards he was seeking, Mikuriya
called the vote a significant step in the right direction. “Last time I attended
a CMA convention was in 1996, and I was all alone in supporting Prop 215, which
they refused to endorse. This time I had numerous allies and there’s a clear
sense among my colleagues that, in order to implement the Compassionate Use
Act, the Medical Board has to issue simple, unambiguous practice standards.”
Enforcement Committee Meeting
Three physicians and about a dozen cannabis-using patients attended the May
8 meeting of the state Medical Board’s Enforcement Committee to reiterate
the need for practice standards and to decry investigations of doctors who
have made a subspeciality of monitoring cannabis use.
The Board’s chief Investigator, David Thornton, sought to reassure the Committee
(and the audience) that his agents were not out to persecute doctors who approve
marijuana use.
Thornton described one “egregious example” of a physician whose “medical office
contained a computer, a print-er and a cash register. There were no other instruments
in that office. There was very little the physician was doing medically in
that office to determine whether there had been an indication for a prescription.
You walked in, you paid your money, your name was put in the computer, and
a letter was generated.”
Thornton testified that the Board has conducted only nine marijuana-related
investigations since the passage of Prop 215. “Nine investigations in six and
a half years is not a lot of investigations,” he said. He supervises about
100 investigators working out of 12 offices statewide. They are currently looking
into about 1,500 cases; another 400-500 have been forwarded to the Attorney
General for possible prosecution. (The AG pursues about 75 percent of those
cases.)
Who Has Been Investigated?
From the perspective of cannabis-using patients, however, the pattern seems
ominous because eight of the nine investigated physicians are responsible
for approximately half the 50,000 approvals issued to date in California.
Most doctors are unwilling to approve the use of cannabis in treating conditions
that are not life-threatening. Therefore, patients who use it to treat migraines,
chronic pain, depression, etc., have obtained their approvals from the small
group of doctors who have made a subspecialty of monitoring cannabis use.
(Several thousand California physicians have approved marijuana use, according
to cannabis-club intake records, but a large majority have done so for only
a few of their patients.)
Two Doctors on Probation
Of the nine doctors who have been investigated by the Board in connection with
marijuana approvals, eight fall into the “subspecialist” category: Stephen
Banister, Tod Mikuriya, William Eidelman, Marian Fry, Frank Lucido, David Bearman,
Mike Alcalay, and R. Stephen Ellis. The ninth is a doctor named Robert Newport
who prescribed a drug for a family member on which the family member overdosed.
Since Newport had also approved the family member’s use of marijuana, Thornton
lists the case as marijuana-related.
Banister, a family practitioner from Nevada City, was one of the first cannabis
subspecialists to be investigated by the Board. The initial complaint against
him came from a probation officer resentful that a client of his named Wesly
Stockdale had a letter from Banister entitling him to use marijuana. When the
Board asked to review his records, Stockdale wrote: “Not only do I find this
to be a gross invasion of my privacy (wherein I also object to the subpoenaing
of my records in any and every way possible) but I believe Dr. Banister to
be a man of high integrity, competence, decency and compassion and I believe
that the review of my chosen physician to be a highly inappropriate and misguided
action.”
Banister eventually agreed to a three-year probation that enabled him to continue
practicing and even to approve his patients’ use of cannabis —but he had to
pay a fine, attend classes at UC San Diego, and be monitored by another physician
for three years. Banister, like Newport, is officially on probation.
Two “Pending” Cases
The Mikuriya and Eidelman cases are officially pending with the AG. Eidelman,
whose practice was in the Los Angeles area, received an interim suspension
order last May; he can’t practice until the case gets settled or heard by an
administrative law judge. “To say his records were inadequate would be an understatement,” says
Thornton. It can be inferred that Eidelman is Thornton’s “egregious example.”
Mikuriya is due to have a hearing in Oakland in September; an administrative
law judge will review 17 patients’ files (obtained by subpoena over the objections
of doctor and patients) to determine whether a proper “standard of care” had
been met. In not one of the cases did the complaint against Mikuriya come from
a patient or a caregiver or another healthcare worker —they were all instigated
by law enforcement agents. Nor did any of the complaints allege harm to a patient!
(See story in this issue.)
Four “Under Investigation”
David Bearman of San Diego has been under investigation since September ’01.
Possession of a letter of approval from Bearman had enabled Patient X to foil
a state park ranger’s attempt to confiscate his marijuana. The ranger filed
a complaint with the Board. questioning the standard of care provided by Dr.
Bearman! The Board then asked Bearman to forward Patient X’s records. Bearman
refused, citing doctor-patient confidentiality. The Board subpoenaed Patient
X’s file. Bearman refused to provide it. The Board recently threatened him
with a $1,000/day fine until he complies. Bearman, who says he takes at least
an hour to conduct an initial exam, is confident that the Board would call
off the investigation immediately upon seeing his documentation of Patient
X’s condition, but he won’t let them see it. Some people just never get over
their 9th grade civics classes.
Three other cases are officially under investigation. The Medical Board’s case
against Frank Lucido involves a teenager whose “hyperactivity disorder” had
been treated unsuccessfully with several pharmaceuticals, including Ritalin,
Prozac, and Lithium, which either didn’t work or caused unacceptable side effects.
Cannabis enabled the kid to attend school (and get excellent grades) as well
as work part-time; but a possession charge led to trouble with school administrators
and law enforcement.
The Alcalay case involved a then-eight-year-old boy whose uncontrollable, frequently
violent behavior was about to result in his removal to a locked-down residential
treatment facility. A cannabis extract —the 20th medication the boy had been
treated with— worked so well that he was able to attend public school and make
friends! Alcalay wrote his initial recommendation based on a review of voluminous
records plus many hours of phone contact with the mother, supplemented by a
trusted assistant’s interviews with her —but no immediate face-to-face interview
with the boy.
The case against Marian Fry seems analogous to the one against Mikuriya. “Every
patient I’ve been asked about by the medical board has passed through the criminal
justice system in either El Dorado or Sacramento County,” she says, “and the
complaints all came from district attorneys, not the patients themselves.”
Ellis Case Dropped
The Board’s investigation into R. Stephen Ellis, MD —a San Francisco physician
who advertises his willingness to write medical marijuana recommendations in
several newspapers— ended with a terse note last September: “The Medical Board
of California is closing the inquiry into the care and treatment you are providing
at this time, based upon the written assurances of your counsel that you have
come into compliance.”
Says Ellis, “They’d had no complaints. My ads caught their attention.”
Public Comment (“keep it brief”)
Medical Board meetings are generally held in featureless, fluorescent conference
rooms at hotels near airports. The May 8 session was at the Double-tree in
Sacramento. Enforcement Committee chair Ronald Wender, MD, gave members of
the public two-to-three minutes each to express their concerns. Excerpted
here are some of their heartfelt comments:
• Phillip Denney, MD, of Loomis, has approved almost 8,000 cannabis-using patients— more
than any doctor in California— but hasn’t been investigated by the Board. “I’m
a 1976 graduate of the University of Southern California. I’ve practiced medicine
in California successfully for 27 years…
Phillip Denney, MD
|
“The recommendation of cannabis in California is lawful. Even with a cursory
review of the literature, cannabis by all tests is a safe, non-toxic drug. We
are not talking about a drug that is dangerous… The government has lied to us
about the use of cannabis and its dangers for the last 32 years. Again, a cursory
review of the literature will bear that out. Seventeen hundred patients die in
this country every year from taking NSAIDS. There has nev-er been a death associated
with cannabis.
When you mention that nine investigations is a small number, you must
consider the effect of those investigations on the rest of the physicians
in California.
“Given this information, the conduct of the MBC that leads to sanctions
of MDs is purely political, and that’s wrong… When you mention that
nine investigations is a small number, you must consider the effect
of those investigations on the rest of the physicians in California.
The sanction of even one physician will have a dramatic impact on the
practices of all others.”
• Dale Schafer (with wife Marian Fry in attendance): “I’m an attorney
and I represent between seven and eight thousand patients. I met with
Mr. Thronton in 2000 and provided him with the protocols of the office
that we were running —how patients were evaluated, the documentation
that we kept. We were informed that if there was a good-faith prior
exam and medical indication, that physicians would be left alone…
“We have found out through the Freedom of Information Act that the law-enforcement
tail is wagging the Medical Board dog. As soon as this law passed in 1996 our
Attorney General [Dan Lungren] met with Barry McCaffrey in Washington and put
together a strategy to scare the bejesus out of any doctor who dared to do this.
Marian Fry, MD and her
husband, attorney Dale Schafer
|
“We have a federal restraining order in place now, the Conant v. Walters decision,
that permanently enjoins the federal government from going after DEA registration.
It’s closing the barn door after the horse is gone. As soon as you threaten a
physician’s DEA registration or their medical practice, they don’t want to touch
this…
“What would the Medical Board do if a police officer called to complain that
somebody with a bottle of Vicodin didn’t have enough pain to qualify for a Vicodin
prescription? Would they investigate? That’s exactly what law enforcement is
doing —they’re playing doctor. If they don’t think you’re sick enough, or they’re
angry that you weren’t prosecuted successfully, they forward a complaint to the
Medical Board. I think that’s the genesis of every one of these investigations
so far…
“We do not have any reasonable protocols for doctors to use if a person comes
in and says I’ve got x, y, or z disease, I want to use marijuana. These investigations
have sent a chilling effect out —just like when Barry McCaffrey pointed to Tod
Mikuriya and said, ‘How dare you put depression on this list? Or post-traumatic
stress disorder?’
“My wife has breast cancer. Her oncologist left the room when we asked if she
could smoke pot! He would give her a prescription for Marinol, and that’s what
kept us from being prosecuted, but he wouldn’t say you can use marijuana. And
if you find a doctor who says ‘Go ahead and smoke marijuana,’ they don’t know
what to tell you next. What do you do? How much? Two point five milligrams is
supposed to be the beginning of a therapeutic dose. Doctors need to be taught
about the cannabinoids! About vaporization! About the old tinctures that doctors
used to use, that you’d drop under your tongue. Doctors are afraid. They’re looking
to the Medical Board for assistance and all they run into is law enforcement —the
tail wagging the dog. We need a moratorium on these investigations until protocols
are developed and doctors are educated in what the protocols are. And then, hold
them to task if they violate these protocols.
• Ryan Landers: “I’ve had full-blown AIDS for seven years. The only
way I can take my HIV cocktail and not throw up or control the cramping
pain and the lack of eating pain —there’s so many different kinds of
pain you get, combined, plus the complete lack of hunger. Without marijuana
I couldn’t take these medications... I don’t get high —I don’t get
a buzz at all, and neither do most patients who use it regularly. Those
feelings wear off, you don’t get that. I’ve tried many different prescriptions —Marinol,
Compazine, you name it. They didn’t work for me and I don’t take them
any more.
Why would you replicate a chemical of a plant if it has no medical
value whatsoever?
“The presence of marijuana on Schedule I makes no sense, given that
Marinol is an extract of the plant’s main active ingredient. Why would
you replicate a chemical of a plant if it has no medical value whatsoever?...
The patients that are receiving marijuana from the federal government
all continue to receive it, and Dr. Ethan Russo’s study shows that
it hasn’t had any longterm negative effects; it’s helping them and
they should continue the treatment.
“I worked on the law that got the research program going here in California,
but I couldn’t sign up for a study under the program because the quality of the
marijuana I would have to use is so inferior to what’s available —only two to
four percent THC.
“I visit an HIV specialist but I don’t ask her do my recommendations
because I don’t want her jeopardized. We need her drastically. I have
another doctor, whom I also see regularly do it… I urge you and I beg
you to encourage your colleagues to stand up and write recommendations
and not force patients to have to search for a doctor who also has
to be in fear. The reason why certain doctors write more recommendations
is that we have to go to them; they’re the only ones who will look
at our situations and deal with it. The doctors we’ve been seeing on
a continuous basis are fearful.”
• Jay Bergstrom: “I just won a round with melanoma, and I made my doctors go
absolutely white and run from the room when I tried to get a recommendation.
The fear is just palpable… And from then on you have to wonder if you’re getting
second-level care, because they’re scared when you come into the office. I can
feel the change ever since I asked for a recommendation.”
• Frank Lucido, MD, a family practioner whose office is in Berkeley, handed the
committee members a detailed prepared statement, plus a statement from Bearman,
then hurriedly read them his key points. He alerted them to the recent resolution
by the California Medical Association urging the Board to issue clear, practical
practice standards for physicians who approve marijuana use by their patients. “Unfortunately, “ Lucido
observed, “there is still no medical or legal definition of ‘good faith exam.’”
Need for Discernment
Lucido called on the Board to “be more discerning in deciding which complaints
to investigate, and from what source.” Top priority, he suggested, should be
given to complaints “from a patient, family member, caregiver, or healthcare
provider alleging that harm was induced by the practitioner.” Lowest priority
should go to “Complaints from other parties alleging standard-of-care violations
(but no harm to patient).
Departing from his prepared text, Lucido glanced towards Thornton
and said, “The derogatory comment about a cash register implies that
people are doing it only for the money. I don’t know any doctor that
doesn’t charge. So I don’t know why that ever came up.
Frank Lucido, MD
|
Lucido oberserved that “the California Narcotics Officers Association website
states ‘There is no justification for using marijuana as medicine’ —a lie contradicted
by the federal govern-ment’s own Institute of Medicine Report.” His bottom-line
advice to the Board: “Drop all ongoing investigations to date of physicians
based on misunderstanding of the law and/or the benefits of medical cannabis,
especially those based only on law enforcement complaints, in light of their
clear misinformation.”
• Steph Sherer, director of Americans for Safe Access, told the Board, “In my
office we receive at least five phone calls a day from seriously ill Californians
who have gone to their doctors and asked if this was a possibility for their
treatment. About 75 percent of the doctors say they won’t recommend cannabis
out of fear of the Medical Board and the federal government. Twenty-five percent
don’t understand the medicinal value of cannabis.” The doctors being investigated,
said Sherer, are the outspoken ones. “People are being attacked for their bravery,” was
her succinct summary of the situation.
Update May 21
CMA, MBC Reps Meet: No Guidelines Yet
CMA and MBC representatives met May 21 to discuss practice standards for physicians
who approve cannabis use by patients. According to MBC public information officer
Candis Cohen, the reps agreed to draft an article to appear in the July “Action
Report,” the MBC’s quarterly newsletter.
Asked if the article would contain a proposal for guidelines (which, presumably,
a member of the Board’s Medical Quality Division would then move to adopt),
Cohen said “I don’t think they committed to actually drafting” a set of guidelines.
Asked if the Board had a timetable for developing guidelines, Cohen replied, “It’s
a work in progress.”
Add Updates
Mike Alcalay received a terse May 31 letter from the MBC stating that his case
would not be forwarded for prosecution.
Proposed Practice Guidelines
By David Hadorn, M.D.
David Hadorn, MD, a specialist in cannabis therapeutics and policy,
was unable to attend the Medical Board Meeting, but submitted a detailed "white
paper". This is his commentary on the term "good faith
examination."
In all cases, the burden of responsibility is on the physician to
ensure that he or she has acquired (and documented) an adequate basis
for (1) making a reasonably secure diagnosis and (2) formulating a
treatment plan. If additional documentation of prior work-up is considered
required – or if additional workup is necessary before a secure diagnosis
can be made, this should be arranged for.
The basic goal for the examining physician to satisfy himself or herself
that initiation or continuation of medicinal cannabis represents an
appropriate treatment option insofar as the expected benefits outweigh
any medical (or legal) risks. Thus, the phrase “good faith examination” could
also be interpreted to mean “acquisition of these appropriate bases
for making a diagnosis and treatment recommendation.”
Based on the above considerations, a basic clinical practice guideline
for cannabis recommendations and approvals can be constructed. The
basic structure of the guideline is probably best explicated in the
form of an annotated algorithm (For a description of this approach
see Hadorn DC, McCormick K, Diokno A. An annotated algorithm approach
to clinical guideline development. JAMA 1992; 267; 3311-3314.)
In this case, the first algorithm node would perhaps consist of the
question “Does the patient has appropriate condition for treatment
with cannabis”? If the answer is “no”, the algorithm ends and the patient
is discharged. If “yes”, the next node would be “Are any relative or
absolute contraindications present?” If “yes”, the patient is discharged,
if “no”, the next node would be “Is diagnosis clear from available
history and documentation of previous evaluation (if any)?” If “no”,
additional documentation and/or work-up is arranged for. If “yes”,
the next node might be “Is specialized physical examination required
to establish the diagnosis”? If “yes” such examination is performed;
if “no”, the next node might be “Is patient experienced in cannabis
use?” Subsequent nodes would refer to details of dosage, preferred
dosage forms, follow-up and related considerations. Each node would
be accompanied by annotation describing the relevant issues and considerations
that apply at each step of the process.