US CA: County Seeks Medical Pot Study Appproval



Source: San Mateo Independent (CA) 



Pubdate: Wed, 31 Mar 1999 



Author: David Burruto, Independent Newspapers 	



ubject: COUNTY SEEKS MEDICAL POT STUDY APPPROVAL	



Supervisor Nevin hopes clinical trials will help change U.S. law 	



San Mateo County has submitted a proposal to the National Institute on Drug Abuse seeking 

approval for a clinical study of the medical use of marijuana. 	



The county-sponsored protocol - a formal proposal and set of guidelines - was submitted to NIDA 

on March 19.	



Approval from NIDA is crucial to conducting the study, as it is the sole federal agency responsible 

for legally providing the drug for such surveys. 	



With NIDA approval, the county will then seek the blessing of the Food and Diug Administration. 

Clinical trials in the county could start this summer at the earliest with approval from both 

agencies. 	



The protocol outlines how to monitor the effects of smoking marijuana on subjects with such 

medical conditions as chronic nausea, anorexia or ameliorating weight loss stemming from AIDS 

treatments and cancer treatments such as chemo or radiation therapies.	



County Supervisor Mike Nevin has helped to spearhead the push for the clinical trials to be 

conducted under the auspices of the county government in county facilities.	



"What hat we've done is we have pushed the envelope as San Mateo County is the first 

governmental entity that's been willing to put its money up to conduct clinical trial," said Nevin.	



"Our hope is that these clinical trials will ultimately lead the United States of America to change 

the law."	



The state of California itself has been at the forefront in support of the legal medical use of 

marijuana, having passed Proposition 215 in 1996 to that effect. Proposition 215 came two years 

in advance of similar measures passed in Alaska, Arizona, Colorado, Nevada, Oregon and 

Washington states, 	



The study will include a group of 60 volunteer subjects being treated for AIDS or cancer. The 

subjects will be divided into two groups of 30. One group will begin taking the drug immediately 

and continue for six weeks, stop, and then continue in the trial for another six weeks without 

taking the drug.	



The second group of 30 will go through the trial in the reverse order. 	



The marijuana will be obtained from NIDA, the sole legal grower of marijuana in the country with 

farms in Mississippi. Under the current proposal, the test subjects will be able to smoke their 

prescribed marijuana cigarettes at home.	



"We submitted the protocol so that they do not smoke on-site, they would be given a supply of 28 

cigarettes a week." said Dr. Scott Morrow, the San Mateo County Health Officer and co-author of 

the proposal. 	



"We submitted it like that because if they were required to smoke on-site that would limit our 

ability to get as many subjects as possible." 	



Morrow suggested, however, that the protocol will be subject to modification due to the 

constraints that NIDA or the FDA will likely impose. 	



The study, according to Morrow, is not the first of its kind but is part of a nationwide effort to 

investigate the drug's usefulness weighed against its harmful side effects.	



Only days ago the National Academy of Science's Institute of Medicine - the private, nonprofit 

organization that provides health policy advice to the federal government under a congressional 

charter - released a report affirming the beneficial uses of marijuana in specific medical cases and 

called for continued clinical trials.	



The report warned, however, that smoking marijuana is a poor system of delivery due to harmful 

side effects, such as an increased risk for cancer and lung damage.	



The Institute of Medicine report also suggested that trials should be limited to patients likely to 

benefit from marijuana most and only for short-term use.	



The county has allocated $50,000 for the initial submission of the protocol and is prepared to 

allocate up to $500,000 for the clinical trial, should it be approved. The trial will, according to 

Morrow, likely be done on an outpatient basis through county clinics. The County Health Services 

Department will hire between two and three research specialists to run the trial.	



A second protocol will be submitted in April that will focus on possible pain relief benefit I of 

marijuana.	



The push to investigate the possible medicinal benefits of marijuana is not, according to Nevin, 

part of an effort to legalize the drug for recreational use, but rather an opportunity for the medical 

community to put it to test. 	



"We haven't given the medical profession chance to breathe or a chance to, in fact, a conclude that 

marijuana does work in specific cases," said Nevin. 	



"It's not my intent to suggest that marijana should be legal, but this substance has some ingredients 

that work in specific cases. it makes sense that it should be an option any other drug."