On Monday, August 18, at 5:00 PM EDT, UC San Francisco issued a press release about the publication by Dr. Donald Abrams and co-authors of an article in the Annals of Internal Medicine discussing the results of their study of the effects of marijuana in HIV+ subjects. Here's the headline, "Short-Term Medical Cannabis Does Not Harm HIV+ Patients," with the rest of the press release at the end of this message.
This is the first publication of the results of a double-blind, controlled study of the effects of smoked marijuana in a patient population in twenty years. It took MAPS and Donald's group five and a half years to get this study started, with help from MPP lobbying NIDA. We leveraged a $10,000 donation to MAPS from Peter Lewis, used to support work by Donald's group preparing protocols, into a $1 million NIDA grant for a compromised but still worthy study. In order to obtain NIDA marijuana, we had to agree to conduct a safety study in HIV+ subjects who didn't suffer from AIDS-wasting, instead of going forward with our FDA-approved safety and efficacy study in treatment-resistent AIDS-wasting subjects. When it came time to report the results, the paper was rejected by several journals that weren't comfortable with its conclusions. Finally, the Annals of Internal Medicine had the courage to publish it.
Now we have yet another response to Dr. Andrea Barthwell, deputy director of ONDCP, who concluded her July 22, 2003 Op-Ed against the medical use of marijuana by saying, "The overarching charge to any physician is: "First, do no harm." That is the test smoked marijuana cannot pass." On the contrary, this new study demonstrates that it has passed that test, at least sufficiently so that Dr. Barthwell's only ethical option is to encourage research into marijuana's potential beneficial uses in patient populations and to recommend that DEA license the UMass Amherst facility to produce high-potency marijuana for medical research.
UC SAN FRANCISCO
Corinna Kaarlela, News Director
Source: Jeff Sheehy, (415) 597-8165
EMBARGOED FOR RELEASE
5:00 PM, EDT, August 18, 2003
TO COINCIDE WITH PUBLICATION IN THE ANNALS OF INTERNAL MEDICINE
UCSF Study Finds No Harm to HIV+ Patients with Short-Term Medical Cannabis.
UCSF researchers found no harmful changes in HIV virus levels in patients on combination antretroiviral therapy in a safety study looking at both smoked marijuana and dronabinol, an oral medical cannabinoid.
"People with HIV are a vulnerable population, so successfully addressing the safety concerns allows us to move on to effectiveness studies, three of which are currently underway here," said study author Donald Abrams, MD, professor of clinical medicine in the UCSF Positive Health Program at San Francisco General Hospital Medical Center (SFGHMC).
The findings, which appear in the August 19, 2003 issue of the Annals of Internal Medicine, mark the first publication of a randomized, controlled study involving medical marijuana in a major peer-reviewed journal in several years.
Sixty-two HIV-infected patients on antiretroviral regimens containing a protease inhibitor completed the 25 day inpatient study. Patients were randomized to three groups--20 received smoked marijuana, 22 received dronabinol, and 20 received an oral placebo.
The study measured changes in HIV virus levels in blood (rising levels tend to indicate disease progression) and CD 4 and CD 8 T lymphocyte cell counts. These disease- fighting white blood cells are essential for defending against infections and are targeted and destroyed by the HIV virus.
The study investigated whether cannabinoids would alter the levels of the virus either by changing the levels of the protease inhibitor medication or by a direct effect on the immune system. Fifty-eight percent of the participants entered the study with levels of HIV virus circulating in their blood below the limit currently detectable by the usual tests. They ended the study with no change in their undetectable status. In all three arms, patients with detectable levels of virus saw no change in the levels of HIV in their blood over the three-week study period.
There was no significant change in CD 4 or CD 8 T-cell counts for the placebo group over the course of the study. CD 4 T-cell counts rose by about 20 percent for both the smoked marijuana and the dronabinol group. CD 8 T-cell counts rose by 20 percent in the smoked marijuana group and by 10 percent in the dronabinol group. "The change in lymphocyte counts for the smoked marijuana group is intriguing. At a minimum, it contradicts findings from previous studies suggesting that smoked marijuana suppresses the immune system," said Abrams.
While not the primary objective of the study, weight gain was observed in all three groups, possibly due to regularly scheduled meals and snacks. Statistically significant weight gain occurred in both the smoked marijuana and the dronabinol arms compared with the placebo arm, though the gain was fat, not in the desired lean body mass compartment.
Co-authors of the study are Joan F. Hilton, DSc, MPH, UCSF associate professor of epidemiology and biostatistics; Roslyn J. Leiser, RN, clinical nurse, Starley B. Shade, MPH, senior statistician, Steven G. Deeks, MD, UCSF associate professor of medicine, and Thomas F. Mitchell, MPH, program director, all in the UCSF Positive Health Program at SFGHMC; Tarek A. Elbeik, PhD, UCSF associate researcher in laboratory medicine at SFGHMC; Francesca T. Aweeka, PharmD, UCSF professor of clinical pharmacology; and Neal L. Benowitz, MD, UCSF chief of the division of clinical pharmacology and vice chair of the department of biopharmaceutical sciences. Also, Barry M. Bredt, MA, specialist, and Morris Schambelan, MD, UCSF professor of medicine and director, General Clinical Research Center at SFGHMC; Bradley Kosel, PharmD, visiting postdoctoral scholar in clinical pharmacology at UCSF; Judith A. Aberg, MD, associate professor of medicine at Washington University, St. Louis, Mo.; Kathleen Mulligan, PhD, UCSF associate professor of medicine at SFGHMC; and Joseph M. McCune, MD, PhD, UCSF professor of medicine at the Gladstone Institute of Virology and Immunology.
The study was supported by a research grant from the National Institute on Drug Abuse, a part of the National Institutes of Health, which also supplied the marijuana cigarettes for the trial. The dronabinol and placebo were supplied by Roxane, Inc., Columbus, Ohio.