Dear MAPS members and supporters,
Great news! Finally, major national attention is being drawn to federal obstruction of medical marijuana research. The New York Times reported today (January 19, 2010), on the first page of the National section, about the DEAs refusal to license Professor Lyle Craker to operate a MAPS-sponsored marijuana production facility at UMass Amherst (the article is pasted in below, or you can read it in its original context here).
Marijuana is the only Schedule I drug of which the federal government has a monopoly on the legal supply for research. The National Institute on Drug Abuse (NIDA) determines who is granted marijuana. NIDAs mission does not include providing marijuana to researchers who seek to develop the plant form of marijuana into FDA-approved prescription medicines.
In 2001, Craker submitted an application to the DEA to start a marijuana production facility sponsored by MAPS in order to grow marijuana for MAPS medical marijuana drug development efforts. After years of inaction by the DEA, Craker filed a lawsuit against the DEA. On February 12, 2007, DEA Administrative Law Judge (ALJ) Bittner presented a recommended ruling that it would be in the publics interest to end the NIDA monopoly on supply by licensing Craker. The DEA failed to respond for almost two years. Then, on January 14, 2009, the DEA rejected ALJ Bittner’s recommendation, just six days before the inauguration of President Obama.
Through skilled legal work on our part, some foolish legal work on the part of the DEA lawyers who sloppily and misleadingly introduced new evidence in their justification for their rejection, and through some political support from Senators Ted Kennedy and John Kerry, and about 12 Congressional Representatives, we’ve achieved a stand-off. The DEA’s final order has not gone into effect because we have a “Motion to Reconsider” pending before the DEA. However, the DEA is currently winning by delay. In turn, we have a pending appeal filed with the U.S. First Circuit Court of Appeals in order to launch a lawsuit should the DEA’s final ruling actually go into effect. Our hope is that new leadership at the DEA will accept the original recommended ruling and reverse the DEAs pending Final Order. Unfortunately, President Obama has not yet appointed new leadership to replace the Bush-era leaders at the DEA.
For a complete history of the struggle by MAPS and Crakers efforts to end the NIDA monopoly on supply of marijuana that can be used in FDA research and to obtain our own independent source of marijuana, see:
Rick Doblin, Ph.D.
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Researchers Find Study of Medical Marijuana Discouraged
New York Times
Originally appeared online at: http://www.nytimes.com/2010/01/19/health/policy/19marijuana.html?ref=us
But the Drug Enforcement Administration more concerned about abuse than potential benefits has refused, even after the agencys own administrative law judge ruled in 2007 that Dr. Crakers application should be approved, and even after Attorney General Eric H. Holder Jr. in March ended the Bush administrations policy of raiding dispensers of medical marijuana that comply with state laws.
All I want to be able to do is grow it so that it can be tested, Dr. Craker said in comments echoed by other researchers.
Marijuana is the only major drug for which the federal government controls the only legal research supply and for which the government requires a special scientific review.
The more it becomes clear to people that the federal government is blocking these studies, the more people are willing to defect by using politics instead of science to legalize medicinal uses at the state level, said Rick Doblin, executive director of a nonprofit group dedicated to researching psychedelics for medical uses.
On Monday, his last full day in office, Gov. Jon S. Corzine of New Jersey signed a measure passed by the Legislature last week that made the state the 14th in the nation to legalize the use of marijuana to help with chronic illnesses.
Studies have shown convincingly that marijuana can relieve nausea and improve appetite among cancer patients undergoing chemotherapy. Studies also prove that marijuana can alleviate the aching and numbness that patients with H.I.V. and AIDS suffer.
There are strong hints that marijuana may ameliorate some of the neurological problems associated with such degenerative diseases as multiple sclerosis, said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.
But there is no good evidence that legalizing the smoking of marijuana is needed to provide these effects. The Food and Drug Administration in 1985 approved Marinol, a prescription pill of marijuanas active ingredient, T.H.C. Although a few small-scale studies done decades ago suggest that smoked marijuana may prove effective when Marinol does not, no conclusive research has confirmed this finding.
And Marinol is no panacea. There are at least three medicines that in most patients provide better relief from nausea and vomiting than Marinol, studies show.
Buddy Coolen, 31, of Warwick, R.I., said he tried or continued to use some of those medicines. Smoking for me is as good as any medicine I have, he said.
Eight years ago, Mr. Coolen contracted gastroparesis and cyclic vomiting syndrome. He lost 50 pounds and, despite being 5 foot 11, weighed 120 pounds.
His doctors gave him myriad anti-emetics, many of which he still takes. They also prescribed Marinol, but it did not work for him, Mr. Coolen said.
My stepdad is old school and was really against marijuana, but then he saw what it did for me and totally changed his way of thinking, Mr. Coolen said.
Some doctors and law enforcement officials say such anecdotes should not drive public policy. Dr. Eric Braverman, medical director of a multispecialty clinic in Manhattan, said legalizing marijuana was unnecessary and dangerous since Marinol provided the medicinal effects of the plant. Our society will deteriorate, he said.
Patients who call Dr. Bravermans clinic are, when put on hold, told that the clinic may prescribe supplements and other alternative treatments that have even less scientific justification than marijuana. Dr. Braverman said such alternatives rendered marijuana unnecessary, but his embrace of alternatives is a reminder that medicine has long been driven by more than science.
About 20 percent of drug prescriptions are written for uses that are not approved by federal drug regulators; about half of the nations adults regularly take supplements; herbal and homeopathic remedies are popular.
The nations growing embrace of medical marijuana has stemmed from these alternative traditions.
The University of Mississippi has the nations only federally approved marijuana plantation. If they wish to investigate marijuana, researchers must apply to the National Institute on Drug Abuse to use the Mississippi marijuana and must get approvals from a special Public Health Service panel, the Drug Enforcement Administration and the Food and Drug Administration.
But federal officials have repeatedly failed to act on marijuana research requests in a timely manner or have denied them, according to a 2007 ruling by an administrative law judge at the Drug Enforcement Administration. While refusing to approve a second marijuana producer, the government allowed the University of Mississippi to supply Mallinckrodt, a drug maker, with enough marijuana to eventually produce a generic version of Marinol.
As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use, said Shirley Simson, a spokeswoman for the drug abuse institute, known as NIDA. We generally do not fund research focused on the potential beneficial medical effects of marijuana.
The Drug Enforcement Administration said it was just following NIDAs lead. D.E.A. has never denied a research registration for marijuana and/or THC if NIDA approved the protocols for that individual entity, a supervisory special agent, Gary Boggs, said by email.
Researchers investigating LSD, Ecstasy and other illegal drugs can use any of a number of suppliers licensed by the Drug Enforcement Administration, Dr. Doblin said. And if a researcher wants to use a variety of marijuana that the University of Mississippi does not grow and there are many with differing medicinal properties they are out of luck, Dr. Doblin said.
Law enforcement tends to emphasize the abuse potential of medicines without regard to their positive effects. Bureaucratic battles between the D.E.A. and the F.D.A. over the availability of narcotics highly effective but addictive medicines have gone on for decades.
So medical marijuana may never have good science underlying its use. But for patients in desperate need, the ethics of providing access to the drug are clear, said Dr. Richard Payne, a professor of medicine and divinity and director of the Institute for Care on the End of Life at Duke Divinity School.
MAPS 309 Cedar Street #2323 Santa Cruz, CA 95060-9989 tel: 831-429-MDMA (6362) fax: 831-429-6370
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