April 27, 2005
Andrew C. von Eschenbach, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Dr. von Eschenbach:
We are troubled by the FDA's April 20th press release in which the agency states that
"[N]o sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." The timing and the lack of substantial information included in this release lead us to conclude that this was a politically motivated statement rather than one based on scientific evidence and fact.
Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. In conjunction with the lack of scientific evidence, it is troubling that your release seemed to defer to the DEA's medical opinions on the drug despite the fact that determining the medical importance of a drug is not in the DEA's jurisdiction.
After deferring to the DEA, your release reads that, "FDA is the sole federal agency that approves drug products as safe and effective for intended indications." Why then has the FDA failed to respond to the 1999 Institute of Medicine (IOM) report which concluded that marijuana's active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials? It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date. Additionally, this release failed to make note of the FDA's Investigational New Drug (IND) Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana. Currently, seven people still enlisted in this program continue to receive marijuana through the federal government. The existence of this program is an example of how the FDA could allow for the legal use of a drug, such as medical marijuana, without going through the "well-controlled" series of steps that other drugs have to go through if there is a compassionate need.
In light of our concerns over this release, please inform us if there is new scientific information that disputes the IOM study, including the results of the evaluation, any scientific paperwork generated in the study, the length of time the evaluation occurred, and whether the DEA or any other federal agencies aside from the ones mentioned in the letter had a role in the evaluation. If, as the press release leads us to believe, there is in fact no evaluation, please let us know what motivated the FDA to write a release that lacks scientific review. It disheartens us to see the FDA veer off course in this area of public health especially at the expense of many terminally ill Americans. We understand that FDA's mission is to protect public health, which is why we respectfully request that you respond to these questions on this very important issue.