US Studying Pot & AIDS

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US Studying Pot & AIDS

Even though the U.S. government officially denies it, marijuana has medicinal value. Now, thanks to the perseverance of a dedicated San Francisco physician who specializes in treating cancer and AIDS, the National Institutes of Health (NIH) and the National Institute of Drug Abuse (NIDA) have provided $1 million to study how cannabis interacts with drugs that help AIDS patients.

According to Dr. Donald Abrams, M.D., the 49-year-old professor, medical researcher, and doctor who designed and gained approval for the pioneering study, the government?s sponsorship represents a major breakthrough in how marijuana is evaluated by the scientific and medical community.

Abrams became especially interested in medical marijuana during the early 1990?s, when he and other Bay Area physicians discovered that thousands of HIV-infected or AIDS patients were self-medicating with marijuana. Patients used cannabis to treat HIV-related anorexia and weight loss, as well as nausea caused by prescription drugs.

As chairman of the Community Consortium, a community-based organization that studies HIV treatment methods, Abrams and colleagues began proposing cannabis studies in 1992. One study regarding appetite and body weight sought to use marijuana brownies produced by the legendary ?Brownie Mary? Rathbun, an elderly hospital volunteer repeatedly arrested for making pot brownies for dying patients.

When that idea failed, researchers proposed using marijuana supplied by a Dutch grower, who promised to produce three types of marijuana for the proposed trial. Even after the Dutch grower already had his clones planted and growing, the DEA killed that proposal, and also sent a letter to the Food and Drug Administration that criticized Abrams, the study design, and the Dutch supplier. The FDA advised the Community Consortium to seek a domestic source for marijuana- NIDA- even though NIDA seemed interested in providing cannabis only for studies that promised to evaluate pot?s negative effects.

From 1993 to 1995, Abrams says, the government stonewalled or arbitrarily turned down study requests. An investigative reporter told Abrams in 1995 that a NIDA official told her that NIDA wasn?t interested in providing marijuana for a study that might show marijuana?s medicinal benefits. Abrams and NIDA?s director, Dr. Alan Leshner, exchanged written unpleasantries.

In July, 1995, marijuana research advocates unfurled banners at a major drug abuse conference, accusing NIDA of politically-biased obstruction of legitimate research. The Consortium developed a new and improved research protocol, which was again shot down by NIDA reviewers. Some of the reviewers? comments indicated that they were prejudiced against marijuana and ignorant of HIV health issues.

?I couldn?t believe the kinds of objections they were raising,? Abrams said. ?There were times when we wondered if we could ever propose anything that would satisfy them.?

After passage of Proposition 215 in 1996, a heavy-handed response from U.S. Drug Czar General Barry McCaffrey, and a wave of protests by doctors who had been threatened by McCaffrey, Abrams met face to face with Dr. Leshner.

?The meeting was civil and productive,? Abrams recalled. ?We gained an understanding of each other, and developed a more positive relationship.?

Soon, the Consortium was focusing on a research involving protease inhibitors- drugs that seemed to offer many benefits to HIV patients. These drugs helped strengthen immune function and also delayed onset of AIDS symptoms, but they tended to cause anorexia, nausea and vomiting. There was also concern about how protease inhibitors would interact with other drugs.

Abrams decided to propose a study wherein the interaction of cannabis and protease inhibitors was studied. He discussed the proposal with NIH and NIDA officials, expecting the typically negative responses he had gotten before.

?I was amazed to find they were quite favorable to it,? Abrams recalled. ?The NIDA people who were assigned to study my proposal felt that they were unable to evaluate a project of its complexity, but they really surprised me by asking if I could recommend reviewers who might give our proposal a fair review. They didn?t want me to recommend members of my family or biased people, but I gave them a list of names, they chose skilled reviewers who reviewed it, and in 1997, we were approved.?

Three years later, the Abrams ?Short-term Effects of Cannabinoids in Patients with HIV Infection? study is up and running at a San Francisco research hospital, and Abrams says there is still room in the study for patients.

?Most if not all the patients we have in the study have already discovered that marijuana helps them,? Abrams said. ?They wanted to be part of the first official study that can help us determine how marijuana affects protease inhibitor therapy. They want to show that marijuana is safe and effective.?

It isn?t a walk in the park being in Abram?s study, however. Patients are selected only if they test positive for the HIV virus and are being treated by protease inhibitors. They become full time residents of a hospital research unit for 25 days. Three patients are tested at a time in a ten bed ward. During the first four days of their stay, they undergo blood tests and other scrutiny as researchers allow them to ?reach equilibrium with their new surroundings.?

On the fourth day, they are randomly divided into one of three test groups.

?Some will get a 3.95 percent THC government-rolled marijuana cigarette,? Abrams explains. ?Others will get Marinol, the synthetic THC derivative. Others will get a Marinol placebo. These three options are delivered before meals three times a day.?

Patients are carefully monitored for caloric intake, resting energy expenditure, weight, body-fat ratios, and other factors.

?This study can even help us understand how marijuana affects people who don?t have HIV,? Abrams said. ?There have been reports that marijuana negatively affects the immune system, and we will be able to track that. Other reports have alleged that marijuana affects hormone levels; we are monitoring hormone levels. So this research will also benefit a larger population.?

Abrams says that the government pot, supplied by a federal pot farm in Mississippi, isn?t the highest grade bud available.

?Patients tell us that it has some seeds in it and is kind of harsh,? he said. ?It comes frozen and is kind of dry, so we have to rehydrate it in a humidifier. Some patients say it is a bit harsh tasting. But it seems potent. They are definitely feeling it.?

Abrams feels a certain amount of pride in having convinced the government to fund his study, but he still encounters political turbulence.

In December, 1998, for example, the Director of Strategy for the White House Drug Control Office, Jim McDonough, said in an op-ed piece in the New York Times that ?there is no scientific proof? that marijuana can be medicinal.

He said that scientific studies of medical marijuana had ?not gone forward because Dr. Donald Abrams at the University of California at San Francisco, who is conducting the only accepted study, has to recruit subjects for a double blind study. But the only thing participants can take while battling AIDS or cancer is marijuana.?

Abrams said he was indignant when he read McDonough?s statement.

?I called him up and said, ?Listen, mister, you managed to get nothing right in what you said. There are no cancer patients in our study. It is not a double blind study, and patients must continue their other therapies while in our study. You got it all wrong.??

Abrams said that McDonough admitted that he may have misread the study protocol, and asked if he and Abrams together could write a correction letter to the Times.

?I wasn?t having any of that,? Abrams recalls. ?I told him that I expect precision and accuracy from the people who work for me, and here he was, in the White House, making these kinds of stupid mistakes. No wonder we end up in international conflicts! And the Times, well to have run what he said without fact checking, and they refused to run the letter I sent them. They ran a small correction instead.?

The award-winning doctor and community activist, whose list of awards, publications and research breakthroughs is 20 pages long, is cautiously optimistic about the future of medical marijuana research.

?I hope that if our study showed that marijuana is helpful, we might see it rescheduled so more research could be done. As far as I can tell, the government is pleased with what we are doing. I?d like to study how marijuana affects the appetite of cancer patients. We are also interested in its analgesic effects. HIV patients often suffer from peripheral neuropathy- nerve pain in the feet so bad that they can?t even walk- and we feel that marijuana might ease the pain. Currently, patients are being prescribed heavy doses of opiods,? Abrams said.

What lessons can be learned from the Abrams success story?

?Never give up,? he says. ?We benefited from having to redesign our study. We learned to be creative and flexible. Now we are learning things that will help people. That?s worth all the struggle.?

People who want to participate in Dr. Abram?s landmark study are encouraged to call 415-502-5705 or 415-502-0657. He can also be reached via email at [email protected]


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