Winter 1995 Vol. 05, No. 3 Clinical Trials and Tribulations
Through the efforts of concerned MAPS readers and dedicated activists, members of Congress are learning of Dr. Donald Abrams’ proposed pilot study comparing smoked marijuana and the oral THC capsule in improving appetite and weight gain in patients suffering from the AIDS Wasting Syndrome. The National Institute on Drug Abuse (NIDA) has not yet decided if it will supply the marijuana necessary for the study, although, for the last several decades, NIDA has provided marijuana to every FDA-approved research project requesting it.
Dr. Abrams’ research project has been supported by the Physicians Association for AIDS Care, the nation’s oldest and largest association of physicians involved with AIDS research and treatment. The Federation of American Scientists has also issued a statement supporting his study. It is the hope of all who follow this issue; patients, caregivers, family members, scientists, and friends alike; that permission will soon be granted to begin this research. Thanks go to those who have concentrated their efforts on urging its swift implementation.
Here are excerpts of some of the letters from members of Congress who support marijuana/AIDS research:
"I am writing to urge speedy approval of his [Dr. Abrams’] still pending request."
– U.S. Rep. Barney Frank (D-MA), to HHS Secretary Donna Shalala on November 1, 1994.
"I agree with you that the federal government has no business usurping from doctors the authority to determine whether marijuana’s medicinal properties can be beneficial to certain patients."
– U.S. Rep. Martin Hoke (R-OH), to a constituent on December 1, 1994
"Given that the Food and Drug Administration has already approved this project and knowing of the beneficial effects that marijuana has for many patients of deadly diseases, I actively urge that this project be carried out as was originally planned."
– U.S. Rep. Harry Johnston (D-FL), to Dr. Philip Lee on December 12, 1994
"Research could provide data the medical community needs to determine the effectiveness of smoked marijuana as a treatment for a variety of significant problems, including appetite enhancement for the AIDS wasting syndrome. I, therefore, encourage your agency to support the continuation of such research."
– U.S. Rep. Melvin Watt (D-NC), to Dr. Philip Lee on January 4, 1995
"I contacted the organizations involved [HHS and NIDA] regarding the study of medical uses of marijuana. ÉI continue to believe that those who can benefit from the medical use of marijuana should be able to get the drug when prescribed."
– U.S. Rep. Gary Ackerman (D-NY), to a con-stituent on January 5, 1995
"I am writing to express my support for Dr. Donald Abrams’ request to NIDA for the marijuana necessary to begin his AIDS research."
– U.S. Sen. Paul Simon (D-IL), to Dr. Alan Leshner, director of NIDA, on January 6, 1995
"I share your support for the medical use of government-supplied marijuana and understand marijuana’s potential to ease the side effects of many diseases and illnesses, including AIDS."
– U.S. Sen. John Glenn (D-OH), to a constituent on January 6, 1995
"Marijuana has harmful side-effects… Nonetheless, I am a strong supporter of medical research and an advocate of the National Institutes of Health. In addition, I trust that the National Institute on Drug Abuse will continue to approve government sponsored research projects according to the established criteria. Should you find that a proposed project is unjustly rejected, I would be interested to see the documentation."
– Rep. John Porter (R-IL) to a constituent on January 18, 1995
"NIDA is the only legal source of marijuana for clinical research purposes. Given the institute’s past support for FDA-approved research, I am at a loss to understand the present delay. Dr. Abrams’ research proposal has been approved by the FDA, the University of California Institutional Review Board and the California Research Advisory Panel and has been endorsed by the Physicians Association for AIDS Care. Surely we can all agree by now that such decisions should be based on scientific merit and not held hostage to political considerations. Officials of NIDA have apparently expressed some concern that the institutes’ supplies would not be sufficient to enable Dr. Abrams to proceed to more extensive trials should his results so warrant. Yet such a hypothetical concern is hardly a sufficient reason to refuse to supply the modest quantity which would allow research to go forward. The effective management of HIV- associated wasting syndrome could prolong the lives of many who are living with HIV/AIDS. I urge that this request be speedily approved."
– Rep. Gerry Studds (D-MA), to HHS Secretary Donna Shalala on January 23, 1995
"I am writing to encourage you to remove administrative barriers to scientific research on the therapeutic effects of marijuana. Last year, The Public Health Service (PHS) refused to reopen the single patient investigational new drug program for therapeutic marijuana because of insufficient scientific evidence to establish safety and efficacy. Now researchers at the University of California, San Francisco are experiencing resistance from the PHS in beginning the necessary clinical trials to answer the scientific questions outlined in last year’s decision. As you know, there is strong support for the medical use of marijuana among AIDS and cancer patients. If objective scientific studies are needed in order to assess the safety and efficacy of this drug, then the PHS should be of assistance in facilitating such research."
– U.S. Rep. Nancy Pelosi (D-CA), to Dr. Philip Lee on February 14, 1995