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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.

 

 

O'Shaughnessy's
O'Shaughnessy's is the journal of the CCRMG/SCC. Our primary goals are the same as the stated goals of any reputable scientific publication: to bring out findings that are accurate, duplicable, and useful to the community at large. But in order to do this, we have to pursue parallel goals such as removing the impediments to clinical research created by Prohibition, and educating our colleagues, co-workers and patients as we educate ourselves about the medical uses of cannabis.
 
SCC
The Society of Cannabis Clinicians (SCC) was formed in the Autumn of 2004 by the member physicians of CCRMG to aid in the promulgation of voluntary standards for clinicians engaged in the recommendation and approval of cannabis under California law (HSC §11362.5).

As the collaborative effort continues to move closer to issueing guidelines, this site serves as a public venue for airing and discussing these guidelines.

Visit the SCC Site for more information.