County health officials achieved landmark approval and support on Wednesday for a medicinal marijuana clinical trials study to be conducted at San Mateo County Health Center. The Federal approval of this clinical study is the first ever of its kind and is the result of a three-year long campaign headed by County Board Supervisor Mike Nevin. There have been smaller clinical trials involving the use of medicinal marijuana but none have been performed at this level, according to Nevin. It will be the first one performed on an outpatient basis - meaning that participants will be prescribed the drug and allowed to administer it at home. It will also be the first one that is sanctioned and supported by the federal government - the University of Mississippi will supply marijuana for the project.
"We are really going to make a mark with this. This effort by us will go a long way," Nevin said. "I hope it will lead the Washington administration to finally act and make marijuana available in pharmaceutical form."
During the course of the 12-week clinical trial study, 60 seriously and/or terminally-ill patients will be recruited into the study. The study will begin recruiting participants at the first of the year, according to Dr. Dennis Israelski of San Mateo County Health Center.
Israelski will be heading up the clinical trials study and brings to the project several years of AIDS clinical trials expertise.
"People have reported that they felt better and I'm not going to stand in their way. So a clinical trial seemed like clearly the most rational, reasonable and perhaps the only possible way to make this happen," Israelski said.
The purpose of the clinical trials is to establish a legitimate process for which the drug can be administered.
Secondary to this is studying the affects that marijuana has on AIDS and cancer patients. "With clinical trials, you generally can't really prove anything," Israelski said. He added that clinical trials are a difficult medium to use to prove or disprove the effectiveness of specific types of treatment.
According to San Mateo County General Hospital administrator Margaret Taylor, the project is a milestone. It is the first time that anyone has garnered such trust from the federal government.
Being the only project of its kind in the country - at a time when the use of medicinal marijuana is being widely debated - San Mateo may very well serve as a national model for medicinal marijuana treatment.
"We are very excited about this project," Taylor said. Participants will first be recruited from the numbers of those already receiving services at San Mateo County General. The project will take in additional patients from other sources.
The groundwork for this project began more than three years ago. In 1996, Proposition 215 passed in California by a slim margin. Prop 215 made it legal for the seriously-ill and terminally-ill to use marijuana in their medical treatment. The Proposition essentially made them exempt from the controlled substance laws - in reference to the possession of marijuana.
The majority of patients who have sought to use medicinal marijuana suffer from AIDS, cancer and glaucoma.
Proposition 215 did not change laws banning marijuana possession or use.
After being approved by the voters, Proposition 215 was tied up in Court. It was questioned by law enforcement officials who wrangled over who would have access to how much and how to qualify the different types of marijuana. It was then challenged by Federal Judge Charles Breyer who attempted to prosecute patients for possession.
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The U.S. Circuit Court of Appeals later forced Breyer to reevaluate the issue. They said explicitly that medical necessity is a valid defense when it comes to the possession of marijuana.
In rebuttal, the Clinton administration stated that federal drug laws take precedence over state legalization efforts, which casted some level of doubt on whether the terminally-ill or seriously-ill would continue to be prosecuted for the use of marijuana.
Finally, the decision ended up at the foot of the U.S. Supreme Court. In a 7-to-1 vote, the Supreme Court overruled Breyer's decision and put the situation back into the hands of California.
The path to providing medicinal marijuana has been littered by highly emotional arguments on both sides as well as intensely fought court battles. One of the major concerns from law enforcement officials is insuring that only the seriously and terminally-ill are using the drug. Officials have pointed to the possibility that patients may take their marijuana dosages to the street to try to turn a profit. Last month in Millbrae a pot club member was in fact arrested by area officials for selling the drug to several teenagers at Mills High School.
At San Mateo County Health Center officials are giving assurances that everything possible has been done to insure that this situation will not occur with their patients.
There will be several procedures in place to monitor the use of marijuana, said Israelski. There will be home visits to make sure the drug is being properly administered and not being sold on the street. In terms of oversight for the participants Israelski said "This is a real world experiment. We've done the best we can, short of videotaping everyone. During the recruitment process we made sure that everyone involved understands how important of a project this is."
He added that participants are strongly encouraged to not use marijuana other than what will be prescribed to them. But added that if someone was using additional marijuana they would not be disqualified or kicked off the trials.
San Mateo County Health Center has recently been the object of some controversy involving the operation of a satellite methadone treatment facility. Neighbors living around the hospital have been vocally opposed to the hospital's intention to bring former drug users into the neighborhood for treatment. When asked if she feels this project may in fact spark further conflict between the hospital and its neighbors, Taylor said she doubted it.
"This will be a very controlled environment. Hopefully no one will be upset," Taylor said. "Hopefully they can appreciate that these people are looking for and need some relief."
Nevin echoed Taylor's comments in reference to the possibility of their being some community backlash against the project. He said that in general the project has been overwhelmingly embraced.
Marijuana has been touted for years, without substantiated proof, as the preferred treatment for symptoms of nausea and the loss of appetite - both commonly felt by AIDS and cancer patents. The project was in fact inspired by the death of Taylor's assistant Joni Commons. Commons died of breast cancer two years ago. It was Commons who convinced Nevin of the merits of medicinal marijuana.
"I was a macho police officer and not affected by these things. But it was Joni's testimony that it was the only thing that gave her any relief," Nevin said. "She was the closest person to me who has ever gone through it. And I was around her when she was dying, and that pretty much convinced me."
Nevin noted that he does not in anyway support the widespread use of marijuana nor does he seek to legalize the substance. "My message is not to legalize marijuana. But to not make it accessible to people who need it does not make sense to me," Nevin added.
The clinical trials will be administered in two phases. The first phase will concentrate on providing marijuana to AIDS patients. The second part of the study will concentrate on cancer patients.
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