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AIDS Treatment News
January 23, 1998

Contents:


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Marijuana, Inflammation, and CT-3 (DMH-11C)

Cannabis Leads to New Class of Anti-inflammatory Drugs

by John S. James

Rheumatoid arthritis researchers are testing CT-3, a synthetic derivative of a metabolite of marijuana, as a potentially new kind of experimental anti-inflammatory drug-- without the gastric and other side effects of today's non- steroidal anti-inflammatories, and without the psychoactive effect or "high" of marijuana. The natural metabolite has the same anti-inflammatory effect, but is less powerful. Although CT-3 is far from human testing, it is interesting for several reasons:

  • Inflammation is not a single process, but many different ones. It may be important in the pathogenesis of HIV disease, and certainly can exacerbating some of its consequences. Much is still unknown, but a new class of anti-inflammatory drugs will open new approaches for research and treatment.

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  • An anti-inflammatory effect separate from the psychoactive effect may be responsible for most of the relief which many patients find from medicinal marijuana. If the only benefit of the drug were in masking pain or other discomfort, then it would be hard to design scientific research except to confirm that the effect is real -- and it is difficult to prove a subjective effect, especially with a substance like marijuana where it is probably impossible to use a placebo effectively. But if the drug is also an anti-inflammatory, then all kinds of research opportunities open up, and the subjectivity problem can usually be avoided.

  • Obtaining the medical without the psychoactive effects of cannabis will be important to patients, since the "high" when it is not wanted is a major drawback, and can be debilitating.

A recent paper(1) on CT-3 (also called DMH-11C, chemical name dimethylheptyl-THC-11 oic acid) was published in the January 1998 Arthritis and Rheumatism. The findings were also presented in November 1997 at the 61st National Scientific Meeting of the American College of Rheumatology.

THC (tetrahydrocannabinol) is the major active ingredient of marijuana; THC is also available legally in the U.S. as the prescription drug Marinol®. When the body metabolizes THC, it produces a number of related chemicals. It was previously known that at least one of these metabolites has anti-inflammatory and pain-relieving effects. CT-3 was produced synthetically by modifying this metabolite so that it is more powerful and can be given in smaller doses.

The paper also acknowledged much earlier work, citing a Chinese text from around 2000 BC. "It was claimed that cannabis 'undoes rheumatism,' suggesting possible anti-inflammatory effects."(1)

Animal tests found CT-3 effective against both chronic and acute inflammation; it also prevented destruction of joint tissue from chronic inflammation. These results suggest possible usefulness against chronic inflammatory conditions such as rheumatoid arthritis.

The drug is currently in very early pre-clinical animal testing. The long safety record of marijuana--no one has ever died of an overdose -- and the fact that a metabolite with the desired anti-inflammatory effect is produced in the body when marijuana is used, strongly suggest that safe and effective anti-inflammatory drugs in this class are possible.

CT-3 should not be confused with a different synthetic marijuana-like drug, WIN 55212, recently reported to reduce pain in animal tests, by neurologists at the University of California San Francisco. Several other university research teams are also studying painkilling effects of cannabinoids. These studies suggest other potential uses of marijuana or its derivatives -- for example, they might reduce the doses of opiates needed to control pain. But this mechanism is different from that of the anti-inflammatory effect of CT-3.

CT-3 is being developed by Atlantic Pharmaceuticals in Raleigh, North Carolina (http://www.atlan.com). The research was done at the University of Massachusetts Medical Center in Worcester, Massachusetts.


References

1. Zurier RB, Rossetti RG, Lane JH, Goldberg JM, Hunter SA, and Burstein SH. Dimethylheptyl-THC-11 Oic Acid: A Non-psychoactive anti-inflammatory Agent with a Cannabinoid Template Structure. Arthritis and Rheumatism January 1998; volume 41, number 1, pages 163-170.


Medical Marijuana: Federal, State Attacks Against California Cannabis Clubs

by Fred Gardner and John S. James

On January 9 the Clinton Administration filed suits to close six medical marijuana buyers' clubs in Northern California; a dozen other clubs operating in the state were not named. This action came more than a year after California voters passed Proposition 215 to allow use of marijuana for medical purposes, and a few days before the effective date of a California court ruling that sales by clubs remain illegal.

The six clubs named in the federal suits are the Cannabis Cultivators Club in San Francisco, Flower Therapy in San Francisco, Marin Alliance for Medical Marijuana in Fairfax, Oakland Cannabis Buyers' Cooperative, Santa Cruz Buyers' Club, and Ukiah Buyers' Club. Proposition 215 changed the California Health and Safety code to legalize possession and cultivation by "seriously ill" Californians using marijuana with the approval of a physician; but the federal prohibitions remained in place. The usual federal practice has been to leave marijuana prosecution to the states unless the quantities are very large.

Closing the clubs, either by state or federal action, would mean that persons with a documented need would still have a legal right to use marijuana for medical purposes under California law--but not under Federal law; and there would be no place where they could legally obtain it. This is a serious problem because even though most social users can find marijuana relatively easily, many patients who need it for medical purposes are not part of that culture, and often have to seek the drug from strangers on the streets, which creates anxiety, costs more time and money, and makes consistent medication virtually impossible.

California Attorney General Lungren has advised local law enforcement officers to make marijuana arrests regardless of Proposition 215--meaning that persons who are seriously ill must still be jailed, and must arrange and pay for an "affirmative defense" establishing that their use was legal under Proposition 215 (which was approved by California voters on November 5, 1996 despite strong opposition from Lungren and Drug Czar Barry McCaffrey).


Background: Federal Attack against Medical Marijuana in California

The federal authorities revealed their first plan on December 30, 1996, at a widely covered press conference. McCaffrey, flanked by U.S. Attorney General Reno and U.S. Health and Human Services Secretary Donna Shalala, warned that a doctor's recommendation of marijuana would "lead to administrative action by the U.S. Drug Enforcement Administration to revoke the practitioner's registration... This isn't medicine," he added, "this is a Cheech and Chong show." Lungren thanked McCaffrey and Reno for "quick action."

But the McCaffrey-Reno-Shalala press conference alarmed many members of the medical community. A January 30 editorial in the New England JOURNAL of Medicine -- "Federal Foolishness and Marijuana," by Jerome Kassirer, M.D., the editor-in-chief derided the U.S. government's policy as "misguided," "hypocritical," "out of step with the public," and "inhumane," and called for reclassifying marijuana from Schedule 1 (drugs of abuse with no therapeutic value) to Schedule 2 (which could allow prescription use, as with morphine).

In February Conant v. McCaffrey, a class-action lawsuit on behalf of all California doctors and patients who discuss marijuana as a treatment option, was filed to prevent the government from prosecuting or threatening to punish them. The suit, assigned to U.S. District Judge Fern Smith, charged that the feds "have intruded into the physician-patient relationship, an area traditionally protected from government interference."

In April Judge Smith (a Reagan appointee) granted a preliminary injunction "limiting the government's ability to prosecute physicians, revoke their prescription licenses, or bar their participation in Medicare and Medicaid because they recommend medical use of marijuana." In a 43-page opinion she wrote, "The First Amendment allows physicians to discuss and advocate medical marijuana, even though use of marijuana itself is illegal... The government's fear that frank dialog between physicians and patients about medical marijuana might foster use does not justify infringing First Amendment freedoms... Defendants may only prosecute physicians who recommend medical marijuana to their patients if the physicians are liable for aiding and abetting or conspiracy under these statues."

It appears that the feds adopted their current strategy (close down the clubs) only after the Fern Smith decision nixed Strategy A (intimidate the doctors). Smith ruled in April. The Justice Department began its investigation of the clubs -- sending undercover agents in to make purchases -- in May, according to the court documents filed January 9, 1998.

All the clubs require documentation of medical need for marijuana, and they verify its authenticity by calling the physician. According to Dennis Peron, founder and maitre 'd of the San Francisco Cannabis Cultivators Club, the U.S. Drug Enforcement Administration not only used false documentation, but also set up a special phone line where a narcotics agent pretended to be in the medical office, and provided the "verification" requested.

Attorney Bill Panzer, who represents the Oakland and Marin clubs, says, "The feds don't want to appear heavy handed. They are not threatening anyone with jail. They are seeking an order saying the club has to shut down. Even if they are successful, and a person violates that order, under the statute that person is entitled to a jury trial. Which means that at some point we'll get to be in front of a jury."

Four of the six federal cases are scheduled to be heard February 20. Panzer thinks there is a chance that one of the judges from whom injunctions are being sought will consider "the real question--the medical efficacy of marijuana." His goal in the legal arguments that will now ensue is to somehow promote a trial in which "the question of whether marijuana is good or bad can be argued in a district court and the whole history of marijuana prohibition can be cited to show that the government has acted arbitrarily and capriciously and that the Controlled Substances Act, as it relates to marijuana -- especially medical marijuana -- has no basis in science, no basis in logic, no basis in rationality." Reminded that the government has, over the years, assiduously avoided allowing this history to be reviewed in open court, Panzer says, "Show me any other time the government has ever filed for an injunction to close down a medical marijuana dispensary?"


Background on State Attack

California Attorney General Lungren, who is also running for governor as a Republican this year, sought to impose his "narrow interpretation" of Proposition 215 from the day it passed. At 12:01 a.m. November 6, he announced (by fax) an "emergency all-zone meeting" of the state's police chiefs, sheriffs and district attorneys. The meeting, closed to the press and public, took place in Sacramento on December 4, 1996. Lungren's interpretation is that Proposition 215 did not legalize transportation, sales or buyers' clubs. Doctors should be forced to testify, he advised, "that the benefits of marijuana use for the specific patient clearly outweigh the risks to the patient -- which is believed to be a scientifically unsupportable finding." Lungren announced he would travel to Washington December 12 to meet with U.S. Attorney General Reno "to ascertain the federal government's detailed prosecution plans."

Lungren's case against the clubs stems from an investigation by state Bureau of Narcotics Enforcement agents against one cannabis club, run by Dennis Peron, in the spring of 1996; this investigation culminated in a raid August 4, and a civil injunction that halted operations. The raid, on the eve of the Republican convention, was widely covered in the media. A Yes-on-215 headquarters was located in the same building as the cannabis club, 1444 Market Street in San Francisco, and Peron protested that the state narcotics agents violated the election laws by examining campaign records.

The San Francisco club was allowed to re-open in January 1997 after Superior court Judge David Garcia ruled that the passage of Proposition 215 entitled Dennis and his associates to provide marijuana "for the personal medicinal use of persons who have designated the defendants as their primary caregiver pursuant to California Health and Safety Code S11362.5."

Lungren appealed Garcia's ruling, and claimed victory December 12, 1997, when two of the three judges on a First District Court panel held that cannabis buyers' clubs are not caregivers under Proposition 215, and therefore have no legal right to distribute marijuana. Lungren immediately sent off a letter (December 15, 1997) to the district attorneys of California's 58 counties suggesting that they consider cracking down on clubs within their jurisdiction. The District Court ruling became effective on January 12, 1998.

Peron has asked the state Supreme Court to review the appeals court ruling. If they take the case, the District Court ruling is vacated (while we await the Supreme Court ruling). If the California Supreme Court denies review--which they usually do--the appeals court ruling becomes final; but Peron can still return to Superior Court in San Francisco to argue that the ruling was based on evidence before Judge Garcia that did not address the club's authentic caregiver role as a support group, social scene, provider of wholesome food, etc. He can introduce new evidence and seek a different ruling on the club's caregiver status.


Comment

All of the medical marijuana clubs in California will not necessarily have to close even if the federal and California governments win the legal disputes currently before the courts. At this time the federal action does not name all the clubs. And so far Lungren has urged local officials to do their own raids, instead of conducting them all from his office in Sacramento. Most of the medical marijuana clubs are on good to excellent terms with their local political and law-enforcement officials; otherwise they would never have opened their doors.

It has always been known, however, that Proposition 215 cannot provide a defense against federal marijuana laws, which do not recognize medical use except for research. (The federal government does have its own medical marijuana program, apparently using the research exception, but only eight patients are currently enrolled and no new people can be accepted.)

The public has strongly supported legitimate medical use of marijuana for years, whenever given a chance to vote or express its opinion in surveys; almost all of the opposition is from government officials and anti-drug professionals. Meanwhile, the scientific case for medical use keeps growing stronger [see "Marijuana, Inflammation, and CT-3 (DMH-11C): Cannabis Leads to New Class of anti-inflammatory Drugs " in this issue]. Far more dangerous psychoactive drugs, like morphine, are successfully allowed in medical use. Somehow marijuana has become a symbolic or political hard line to be maintained by anti-drug believers regardless of human cost. The costs will mount until the public can organize itself to insist that those who urgently need this medicine can obtain and use it legally.

[Fred Gardner is managing editor of Synapse, the weekly newspaper at the University of California San Francisco Medical Center. He is a former editor of Scientific American.]


Medical Marijuana: The Will Foster Case in Oklahoma

by John S. James

The new information on anti-inflammatory effects of marijuana [see "Marijuana, Inflammation, and CT-3..." above] is also relevant to the case of Will Foster in Tulsa, Oklahoma. This case shows the need for legal recognition of medical marijuana, and other law reform.

In January 1997 Will Foster, who ran a software business and was formerly a military policeman, was sentenced to 93 years in prison for growing marijuana in his basement to treat his severe rheumatoid arthritis. He had no criminal record.

The sentence consisted of 70 years for growing the plants, 20 years for doing so in the presence of children (his own, who according to Foster never saw or knew about the marijuana, which was in a locked room), and three years for miscellaneous marijuana offenses. While researching this case we looked for indications of anything else that could explain the severity of the sentence, but could find nothing. Foster refused to plead guilty and accept a 12-year sentence, and instead had a jury trial -- said to be unheard of in Tulsa in a marijuana possession or cultivation case, which usually leads to a plea bargain.

Will Foster's wife Meg had difficulty finding a lawyer in Tulsa to handle an appeal, but an appeal was filed on September 6, 1997. Two weeks later Foster was transferred to a prison in Texas, 400 miles from his family, where he remains today. He was unable to get his prescription medications or even minimal medical care for his arthritis, until public pressure was organized. The Oklahoma governor rejected requests for clemency.

More information about the case, including updates, a detailed statement by Will Foster, a 2000-word article in Reason magazine, and how people can help, can be found at: http://www.gnv.fdt.net/~jrdawson/willfoster.htm.


Micronutrients and the HIV Patient, March 23-24 in Boston


"This meeting is designed for physicians, scientists and other health professionals trained in nutrition and HIV/AIDS disease management. The overall objective is to evaluate the scientific data concerning the role of micronutrients in the treatment of HIV or AIDS. Specific focus will be placed on the antioxidants (vitamins A, C, E, and beta carotene), the B-complex vitamins, and minerals (iron, zinc, and selenium). The discussion will address:

  1. provisional recommendations on use of supplemental micronutrients and minerals in HIV/AIDS, and
  2. development of priorities for intervention trials to investigate the effects of micronutrient supplementation on HIV/AIDS progression."

The meeting will be chaired by Sherwood Gorbach, M.D., Ronenn Roubenoff, M.D., and Margo Woods, Ph.D. It is sponsored by Serono Symposia USA and Tufts University School of Medicine. Since it was only recently announced, this meeting has not yet been widely publicized.

For more information contact: David Pherson, Ph.D., Serono Symposia USA, Inc., 800-283-8088x2372, or 781-982-9000x2372, or fax 781-982-9481.


Scholarships Available for Geneva Conference

Application Deadline March 8


On January 8 the National AIDS Fund announced scholarships of up to $3,500 for persons involved in community-based service organizations to attend the 12th World AIDS Conference, June 28 - July 3, in Geneva, Switzerland.

"Applicants must be actively involved in community-based HIV/AIDS organizations. Preference will be to those applicants who do not have the resources -- or who would not normally have the opportunity -- to participate in educational opportunities of this scope. Applicants will be selected by a panel of representatives from the nation's major HIV/AIDS organizations and institutions."

Major funding this year for the Community Advocates Scholarship Program is from Merck & Co., Glaxo Wellcome, Roche Laboratories, Pfizer, Agouron Pharmaceuticals, and Gilead Sciences.

Applications are due at the National AIDS Fund on March 8; they must include a letter of support, and cannot be submitted by fax.

For more information, or to obtain the application form, contact Ken Aldrich, Scholarship Liaison, National AIDS Fund, 202-408-4848, 9:00 a.m. to 6:00 p.m. Eastern time. Or call any time and leave your fax number.


More Attention to HIV Reporting As GMHC Changes Policy

by John S. James

On January 14 the Gay Men's Health Crisis, the nation's largest AIDS service organization, announced that it had changed its position and now supported a new monitoring system to report cases of HIV infection in New York State, through a system of "unique identifiers" for patients (instead of patients names) to provide the best privacy protection (see "AIDS Group Urges New York to start reporting of HIV," The New York Times January 13, page 1). Many other large and small AIDS organizations remain strongly opposed. The push for reporting cases of HIV infection to government agencies has developed great momentum in the last few years, and it is now widely believed that HIV reporting will eventually become required in all states, probably by name. Therefore the AIDS community needs to analyze the considerable concerns about and objections to names reporting, to be able to propose ways to reduce the harm which is feared.

Today all states require doctors and clinics to report cases of AIDS. About half the states also require them to report HIV infection; however, the states where most people with AIDS live, including New York and California, do not. Only a handful of states have outlawed anonymous testing clinics. But everywhere in the U.S. it is possible to test oneself privately, by using the FAD-approved HIV test kit from Home Access Health Corporation, the only approved HIV home test kit currently available in the U.S. The retail price is about $40.

The GMHC's main arguments for HIV reporting are to use the data collected to help provide treatment for people infected, and to design better prevention programs to reduce new infections. Another prominent argument -- from others -- is to end "AIDS exceptionalism" so that HIV is not treated differently from other reportable diseases such as syphilis -- even though there seems to be little evidence that such "traditional public health measures" ever were effective.

GMHC proposes a number of safeguards, including involving affected communities in developing a new surveillance system, assuring strong privacy safeguards, not linking HIV surveillance to non-surveillance activities like mandatory partner notification or the criminal justice system, and preserving free, publicly funded anonymous testing. It also calls for federal and state confidentially protection for medical records [which today are far more accessible and open to abuse than the surveillance records kept by state government health agencies, as there is no comprehensive federal statute giving individuals privacy rights concerning their medical records]. On January 16 GMHC, several other AIDS organizations, and the American Civil Liberties Union held a press conference to urge that coded identifiers, instead of names, be used in any HIV reporting system in New York State.

Most of the concerns about HIV names reporting focus either on loss of confidentiality and resulting discrimination, or on deterring people from being tested for HIV. Some of the dangers are:

  • Protection from discrimination through the Americans with Disabilities Act (ADA) is not assured for persons with HIV. While the ADA certainly covers persons with AIDS, a federal appeals court in Virginia ruled in August 1996 that it did not cover discrimination due to asymptomatic HIV infection. That ruling applies to only a few states, and has been appealed to the Supreme Court, but as of today it is the highest court ruling on the matter. Apparently it means that people can be fired, evicted from their apartment, denied a mortgage, etc. simply because they have HIV (unless they also have AIDS-related symptoms and would therefore be protected by the ADA). This result undermines the common argument that mandatory reporting should be more acceptable, now that discrimination protection is in place.

  • Many people will avoid being tested if they cannot do so anonymously. Both legal and undocumented immigrants reasonably fear deportation, unless they are sure that the HIV surveillance data will not be used for such purposes -- and how can such assurance be reliable? Anyone may be concerned that, if the ADA is ruled not to apply to asymptomatic HIV, there may come a time when they have to say they are HIV negative to avoid losing a job, mortgage, or something else for which they are otherwise qualified; therefore they might think twice about creating even a confidential official record that could prove they had lied. The central problem is the uncertainty -- that without either anonymous testing or discrimination protection, persons deciding to be tested must weigh all possible futures if they want to protect their interests, before making what could be an irrevocable decision to put their names on the list.

  • Mandatory names reporting of HIV test status could make it harder to recruit HIV-negative volunteers for vaccine trials -- since most vaccines will cause people to test positive, even though they are not infected.

  • Supporters of HIV surveillance have not adequately explained to the community the hoped-for benefits; most of the AIDS community has little concrete picture of how HIV reporting could contribute to anyone's health. It is hard to see how better data will result in more people getting treatment, since it will not increase the number who know they are HIV positive (and may even do the opposite, as some people will be deterred from being tested). Better data might or might not result in more access to care, through more or better targeted care dollars. The new surveillance data may well improve prevention efforts, but just how has not been well explained to non-professionals.

The GMHC policy change came as a surprise to many other AIDS activists in New York -- suggesting lack of broad community dialog and education. Given the lack of consensus, it is not surprising that many grassroots activists believe that the real organizational incentive for HIV surveillance is money -- to improve the funding stream by making sure that cases which could justify additional payment are not missed.

A related concern is that government agencies may want the data in order to avoid paying multiple organizations for different services to the same client. Ultimately this might force consolidation of many small AIDS organizations into a few large ones, reducing participation and increasing the remoteness of "AIDS Inc." from those it serves.

  • It also does not help that outside of the AIDS community, much of the case for surveillance has been fueled by hostility, not pragmatism -- for example, right-wing calls for an end to "AIDS exceptionalism" as if the issue is special privileges or favors that should be taken away on principle, by imposing a far-reaching policy change for "moral" reasons with no need to show any actual benefit.

The larger issue is that most AIDS policy so far has been built on a fundamental premise of involvement and voluntary cooperation of those infected, instead of on coercion. This voluntary approach has worked well. HIV reporting does not necessarily threaten the policy of cooperation. But it will be a threat if imposed without the meaningful consultation and discussion which could bring unintended consequences to light.



ISSN # 1052-4207

Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.




  
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