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How the US federal government is blocking medical marijuana research

From The Marijuana Policy Project
http://www.mpp.org

The National Institute on Drug Abuse (NIDA) controls the only legal supply of marijuana for research in the United States. Before scientists can study marijuana's medical benefits, they must ask NIDA for its marijuana. And NIDA Director Alan Leshner just says no.

In the 1970s and early 1980s, it was not so difficult for scientists to obtain marijuana to study its medicinal qualities. More than 70 studies found that marijuana is an effective medicine. But a few more studies must be conducted to satisfy the rigid requirements of the Food and Drug Administration (FDA) so that marijuana can be approved as a prescription medicine.

The Clinton administration does not want this to happen. While the U.S. Department of Justice threatens doctors and arrests patients who are already using medicinal marijuana, the U.S. Department of Health and Human Services (HHS) is working to prevent FDA approval.

NIDA is part of HHS. And NIDA Director Alan Leshner is HHS's point man in charge of blocking medicinal marijuana research.

 

Why is it important for marijuana to be approved by the FDA as quickly as possible? Tens of thousands of seriously ill people nationwide are already using marijuana for medicinal purposes -- illegally.   The federal penalties are: Possession of one joint -- up to one year in prison; Cultivation of one marijuana plant -- up to five years in prison.   People with AIDS, cancer, glaucoma, and multiple sclerosis who are currently benefiting from medicinal marijuana must live in constant fear of being arrested and sent to prison. Because the FDA-approval route is being thwarted by NIDA, there is a move across the country to pass state and local laws to remove criminal penalties for possessing or growing one's own medicinal marijuana.

 
Dr. Leshner denies that he is trying to block research. But if Leshner wanted to expedite medicinal marijuana research, he would provide NIDA's marijuana to all researchers as soon as they receive the FDA's permission to begin a study.

Instead, Leshner crafted a brilliant scheme to thwart research. He created a new NIDA policy in 1995 that requires all researchers to apply for and receive a federal grant from the National Institutes of Health (NIH) before they can receive any marijuana -- even if they do not need federal money. If NIH refuses to approve the study, then NIDA will not provide any marijuana.

Of course, NIH rejects the vast majority of funding requests for all kinds of studies because of the strong competition for limited funds. Knowing this, very few researchers have even tried to obtain NIDA's marijuana.

Pharmaceutical companies do not face this extra hurdle. When they develop new synthetic drugs, they can begin their research as soon as the FDA gives them permission to begin their studies.

If a study does not require federal funding, there is no good reason to make the scientist apply for a federal grant. Scientists who want to study medicinal marijuana should not have to apply for an NIH grant if they have state or private money with which to conduct their research. NIDA should provide its marijuana to all FDA-approved research, regardless of how the research is funded.

In February 1997, NIH convened an expert group to make recommendations regarding medicinal marijuana research. The expert group's report, released in August 1997, urged NIDA to change its policy. The group wrote:

"Whether or not the NIH is the primary source of grant support for a proposed bona fide clinical research study, if that study meets U.S. regulatory standards the study should receive marijuana and/or matching placebo supplied by the National Institute on Drug Abuse (NIDA)."

In December 1997, the American Medical Association (AMA) also officially recommended that marijuana "be supplied by the National Institute on Drug Abuse to investigators registered with the Drug Enforcement Agency [sic] who are conducting bona fide clinical research studies that receive Food and Drug Administration approval, regardless of whether or not the NIH is the primary source of grant support."

But NIDA Director Alan Leshner refuses to take the advice of the NIH expert group and the AMA. He refuses to change NIDA's restrictive, unfair policy.

Even when NIDA's policy does not prevent research outright, it severely delays research and forces scientists to change their study designs, making them less likely to find useful results.

For example, in 1994 Dr. Donald Abrams of the University of California at San Francisco asked NIDA for marijuana after his study design was given the green light by the FDA.

After nearly a year of stalling, NIDA Director Alan Leshner told Dr. Abrams that he would need to submit a grant application to NIH. So Dr. Abrams submitted a grant application in April 1996 -- and it was rejected four months later. NIH said that the study should focus on marijuana's safety as opposed to efficacy.

Dr. Abrams complied and submitted a third proposal in April 1997. This proposal, dramatically different from the first, was approved -- at a cost of $1 million to the taxpayers. (The original study design would not have required government funding.)

The $1 million study began in early 1998 -- four years after Dr. Abrams asked for marijuana. And now it's not even the same study!

Another researcher trying to obtain marijuana to study migraines is presently going through the same ordeal. Countless other researchers are deterred from even trying to obtain marijuana for research.

The Marijuana Policy Project Foundation believes that NIDA should provide its marijuana to all FDA-approved studies, whether funded by taxpayer dollars or private citizens. Additionally, NIDA should lose its monopoly on the domestic supply of marijuana for research so that studies can also be conducted with non-government marijuana.

Q:	Why would the federal government want to block research?
A:	Because the drug warriors want to keep medicinal marijuana illegal, by any means necessary.
Q:	Why?
A:	The answer is revealed in this cartoon, which appeared on the cover of a brochure advertising a government-sponsored anti-medicinal marijuana conference in Florida in May 1998:

 
The government believes that its "war on drugs" must be won at all costs, even if that means punishing seriously ill people.

The Marijuana Policy Project Foundation believes that the sick and wounded should be removed from the battlefield. If you agree, please contact Dr. Leshner's office and tell him that "NIDA should provide marijuana to all FDA-approved studies, without requiring an NIH peer review" -- 301-443-6480.