Press coverage of the MAPS/Craker/DEA hearing August 22-26, 2005
CSPAN
ACLU's August 22nd press conference broadcast live, viewable here.

The Republican
August 29, 2005
U.S. war on drugs takes no prisoners
Editorial

New York Times
August 27, 2005
Marijuana Pipe Dreams
By John Tierney

Chronicle of Higher Education
August 25, 2005
Legal Showdown Over Medical Marijuana Pits Umass Against Ole Miss, Sole Purveyor of Research Pot
By Jeffrey Brainard

The Boston Phoenix
August 25, 2005
The Right to Grow
By Mike Milliard

Sacramento Bee
August 25, 2005
Clash over pot research gets personal
By Michael Doyle

Journal of the American Medical Association
August 25, 2005
Medical Marijuana, American Federalism, and the Supreme Court
By Lawrence O. Gostlin

Duluth News Tribune
August 23, 2005
Professor appeals rejection of pot research
By Elise Waxenberg

The New Standard
August 23, 2005
Medical Marijuana Hearings Begin
By Brendan Coyne

Family News in Focus
August 23, 2005
ACLU Wants DEA Approval for Marijuana Research
By Bill Wilson

Blogs
The hearings and their coverage have also received positive mentions at several prominent blogs, including Salon's DrugWarRant, Reason's Hit and Run, and Ann Althouse's blog.


The Republican
August 29, 2005
U.S war on drugs takes no prisoners
Editorial

The federal government says it won't approve the use of marijuana as a prescription medicine because it hasn't seen any scientific evidence to prove that it has any health benefits.
So what happened when Lyle Craker, a plant and soil sciences professor at the University of Massachusetts at Amherst, applied to the U.S. Drug Enforcement Administration for a permit to grow high-grade marijuana for scientific research in 2001?

The DEA lost his application.

And then it said he had not filled out the forms correctly.
And then it sent two DEA agents to the Amherst campus to discourage the university.
And finally the DEA rejected his application.
Last week, Craker appealed the decision to an administrative law judge.
When the DEA looks at Craker, it can't decide whether he's Cheech or Chong. He is neither. It's time the DEA stopped fighting the war on drugs in his plant rooms on the Amherst campus and gave him an opportunity to grow high-grade marijuana for research.

For a federal government that has been waging a decades-long war on drugs with little measurable success, it is difficult, if not impossible, to admit that there might be some medical benefit to marijuana. This was demonstrated by John Ashcroft when he spent much of his tenure as attorney general threatening to prosecute sick people in California for using medical marijuana while the rest of the nation lived in fear of another terrorist attack.

In a 6-3 decision in June, the U.S. Supreme Court ruled that strict federal drug laws prevailed over the California law, but Justice John Paul Stevens suggested in his majority opinion that Congress has the authority to change the law that classifies marijuana as a dangerous drug.

The refusal of the DEA to give Craker permission to grow marijuana suggests that it doesn't want the drug to ever be available as a prescription medication. Much of the government research being done today on marijuana asks scientists to find its harmful effects, not its potential benefits.
Congress should put an end to that reefer madness.

New York Times
August 27, 2005
Marijuana Pipe Dreams
John Tierney

When the Supreme Court ruled in June that states could not legalize marijuana for medical uses, Justice Stephen Breyer voted with the majority. But during oral arguments, he suggested an alternative way for patients to get it: let the federal Food and Drug Administration decide if marijuana should be a prescription drug.

"Medicine by regulation is better than medicine by referendum," he said. In theory, that sounds reasonable. But what if the officials doing the regulation are afflicted with a bad case of Reefer Madness?

If you doubt this possibility, you should have been at a hearing that began this week at the Drug Enforcement Administration's headquarters. Lyle Craker, a professor of plant and soil sciences at the University of Massachusetts, asked an administrative judge to overrule the agency so he could grow marijuana for F.D.A.-approved research projects by other scientists.

Dr. Craker is a well-regarded agronomist who's being supported by the American Civil Liberties Union and both of his senators, Edward Kennedy and John Kerry. But for four years he's been stymied by the D.E.A., which first stalled and then finally denied his request for a permit.

There are precedents for his re quest, because researchers already get supplies of other drugs - like heroin, LSD and Ecstasy - from independent laboratories licensed to make them. But researchers who want marijuana have only one legal source: a crop grown in Mississippi and dispensed by the National Institute on Drug Abuse.

Scientists say they need an alternative partly because the government's marijuana is of such poor quality - too many seeds and stems - and partly because the federal officials are so loath to give it out for research into its medical benefits.

Discovering benefits, after all, would undermine the great anti-marijuana campaign that has taken hold in Washington. Marijuana is deemed to be such a powerful "gateway" to other drugs that it's become the top priority in the federal drug war, much to the puzzlement of many scientists, not to mention the police officers who see a lot of worse drugs on the streets.

People with glaucoma and AIDS have sworn by the efficacy of marijuana, and there have been studies by state health departments showing that smoking marijuana is especially good at controlling nausea. Scientists would like to test these effects, but they can't do good studies until they get good marijuana.

Critics of medical marijuana say that it's unnecessary because patients can obtain the benefits of its active ingredient, THC, through a drug that's already available, Marinol. But many patients say it doesn't work as well. They point to the case of the writer Peter McWilliams, who said smoking marijuana was the only way to control the nausea brought on by the mix of drugs he took for AIDS and cancer.

He was forced to switch to Marinol after a D.E.A. investigation led to his conviction for violating federal laws against marijuana. In 2000, several weeks before he was to be sentenced, he was found dead in his bathroom. He had choked on his own vomit.

Phillip Alden, a writer living in Redwood City, Calif., told me that marijuana was a godsend for him in dealing with the effects of AIDS. He said it eased excruciating pains in his fingertips, controlled nausea and enabled him to avoid the wasting syndrome that afflicts AIDS patients who are unable to eat enough food.

But Mr. Alden said only some kinds of marijuana worked - not the weak variety provided by the federal government, which he smoked during a research study.

"It was awful stuff," he said. "They started out with a very low-grade plant, rolled it up with stems and seeds, and then freeze-dried it so that they probably ruined any of the THC crystals. All it did was give me headaches and bronchitis. The bronchitis got so bad I had to drop out of the study."

Mr. Alden was scheduled to testify at this week's hearing, but he told me he had to withdraw because the D.E.A. refused to give him legal immunity if he admitted using marijuana not from the government. It's a shame the judge will be making a decision without hearing him, but I can understand Mr. Alden's hesitancy.

D.E.A. officials have already shown they're quite capable of persecuting someone who uses marijuana to deal with AIDS, and they may well be even more eager to go after someone who encourages research into their least favorite drug. When it comes to marijuana research, the federal policy is "Just Say Know-Nothing."

Chronicle of Higher Education
August 25, 2005
Legal Showdown Over Medical Marijuana Pits UMass Against Ole Miss, Sole Purveyor of Research Pot
Jeffrey Brainard

An administrative hearing began here this week on an appeal that pits two universities in a debate over medical marijuana. A researcher at the University of Massachusetts at Amherst wants permission from the U.S. Drug Enforcement Administration to grow cannabis that could be used to develop legal prescription drugs. The University of Mississippi, which opposes the request, is the sole source sanctioned by the government to grow marijuana for that purpose.

Massachusetts argues that Mississippi's product is of insufficient potency and that the government has released too little of it to researchers. The DEA says the supply is ample, adding that other researchers have found the crop sufficient to meet their research needs.

In December the DEA turned down the request from Lyle E. Craker, a professor of plant and soil sciences at Amherst who is an expert on the production of medicinal plants. He appealed and is now represented by the American Civil Liberties Union. A hearing began Monday before an administrative-law judge, whose decision will not bind the agency. Nevertheless, ACLU officials said they hope that if they win the appeal, they can persuade the agency to reconsider. A decision is expected by January.

The hearing began just two months after the U.S. Supreme Court ruled that the federal government may block state governments from allowing patients to use marijuana for medical purposes. During oral arguments in that case, Gonzales v. Raich, at least one justice, Stephen G. Breyer, suggested that patients who wanted to receive cannabis should persuade the Food and Drug Administration to approve the plant for medical use. Mr. Craker and his supporters say the Massachusetts project is aimed at providing the scientific evidence to do just that.

However, some scientists have said that the DEA and the National Institutes of Health have blocked some marijuana research because they are biased against studies that do not focus on the plant's health hazards for patients and recreational users (The Chronicle, June 2, 2000).

Mr. Craker and his supporters advocate expanded research on both benefits and risks. "The DEA's refusal to permit me to grow marijuana for research necessarily prevents an accurate assessment of this plant's potential medicinal properties," he said.

In June 2001 he sought the DEA's permission to grow pot at his university. The effort was to have been financed by a nonprofit, Washington-based group, the Multidisciplinary Association for Psychedelic Studies, that advocates research on the medical and "spiritual" uses of marijuana. The DEA's decision in December came after he and the association sued the agency for dragging its feet.

[MAPS Note: The MAPS main office is located in Sarasota FL, not Washington.]

The Amherst project would study optimal growing conditions to cultivate marijuana useful for medical studies. The growing plot would be located behind locked doors, under artificial lighting, in the horticulture department's building. But the actual medical studies would be conducted at other institutions.

The psychedelic-studies association has proposed to sponsor research into whether marijuana could be used, for example, to relieve the nausea that patients with cancer and AIDS suffer as a side effect of medications they take. The Food and Drug Administration has already permitted the use of a marijuana extract in pill form, called Marinol, to treat such symptoms. But some patients with nausea can have trouble keeping those pills down.

In particular, the association wants to study alternatives to smoked marijuana, including one that would heat marijuana without burning it to create a vapor containing medically active ingredients. The DEA has said that smoked marijuana probably cannot be licensed for medicinal use because of the health hazards posed by smoke.

The association also argues that a second source of marijuana is needed because the National Institutes of Health and the Department of Health and Human Services rejected applications from at least two other researchers for access to the Mississippi marijuana, which the department controls. (One of those decisions was reversed after the scientist changed his study to focus on cannabis's risks rather than its potential benefits.)

The association's president, Richard E. Doblin, said at a news conference on Monday that he had invited Mr. Craker to participate because of his expertise and because he is not an advocate for legalizing marijuana for recreational use. "I'm very much against recreational use, and I have never used it," Mr. Craker said in an interview.

In addition, Mr. Doblin said, Mr. Craker was a senior, tenured faculty member who would be protected from any potential political backlash over the research.

Mr. Craker and Mr. Doblin's association argue that the marijuana available from Mississippi is not sufficient for the studies because it is too weak. They are seeking a content of 7 percent to 15 percent by weight of tetrahydrocannabinol, or THC, the plant's psychoactive ingredient. The Mississippi pot typically has a content of about 4 percent or less, although the facility has produced some batches with a content of 10 percent or higher.

Few clinical studies have been conducted on the medical benefits of marijuana. But some patients who have been given the government-sanctioned pot have complained that either it had no effect or they had to smoke it for long periods to experience any, Mr. Craker said.

He and the association also argue that the Mississippi pot generally has too many seeds and stems to be useful for their research. The THC typically is concentrated in the plant's leaves and buds, while seeds tend to explode when heated.

In its pre-hearing documents, the DEA defended the Mississippi marijuana. The agency argued that researchers at the University of California at San Diego who used it in their preliminary clinical studies said it was of sufficient quality for their purposes. The university installed a custom-made de-seeding machine that has operated effectively, the agency argued.

The DEA has also raised health concerns about giving research subjects high doses of THC.

Mr. Craker has already won support from Massachusetts' Congressional delegation, including its senators, Edward M. Kennedy and John F. Kerry. In a 2003 letter to the agency's administrator, the two Democrats called the Mississippi contract an "unjustifiable monopoly."

The University of Mississippi has contracted with the National Institutes of Health since 1968 as the sole source of government-approved cannabis. The university currently has an inventory of more than one ton and a full-time staff of 10 that cultivates the marijuana on a 14-acre, outdoor plot surrounded by a double row of security fences.

The full text of the Supreme Court's decision in Gonzales v. Raich, No. 03-1454, is available on the court's Web site.

The Boston Phoenix
August 25, 2005
The Right to Grow
A second chance for medical marijuana?
Mike Milliard

Dr. Lyle Craker, a professor of plant and soil sciences at UMass Amherst, has been trying since 2001 to get a license from the Drug Enforcement Administration (DEA) to grow research-grade marijuana for use in Food and Drug Administration-approved studies of the plant's potential to become a legally prescribed medicine. Last December, after more than three years of stonewalling, the DEA officially rejected his application, holding that his study "would not be consistent with the public interest." (See "Up in Smoke," This Just In, December 17, 2004.)

Now Craker, along with the Belmont-based Multidisciplinary Association for Psychedelic Studies (MAPS) and the ACLU's Drug Law Reform Project, is challenging that ruling. Hearings began in Washington this week before DEA administrative-law judge Mary Ellen Bittner. Supporters hope the proceedings will end the DEA's obstruction and remove the federal government's monopoly on research marijuana.

In the wake of the Gonzales v. Raichdecision in June, in which the Supreme Court affirmed that federal law supersedes state law in matters of drug enforcement, FDA approval is really the only avenue left for medical marijuana. Before that can happen, there must be studies into its safety and efficacy. "We have considerable lay information about the potential health benefits of this plant material, but we lack the scientific studies that are necessary to prove the value of medicine," Craker told the Phoenix in December. "The first step in that is producing quality plant material that will have bioactive constituents in it."

But at the moment, all marijuana used for research in the US comes from a closely monitored crop maintained by the National Institute on Drug Abuse (NIDA). The complainants in the Craker case maintain that the supply is insufficient, and of inadequate quality, for proper research - let alone for prescription sale should the FDA ever approve it. Moreover, the feds are stingy in distributing the plants. MAPS president Rick Doblin says that just last week, NIDA refused to provide 10 grams of marijuana for a MAPS-sponsored vaporizer study at Chemic Labs in Canton.

Last month, Democratic Massachusetts representatives John Olver and Michael Capuano sent a letter to DEA administrator Karen Tandy, expressing "strong support" for issuing Dr. Craker's license and pointing out that NIDA's monopoly makes little sense since the DEA has licensed privately funded production of other Schedule I drugs, such as MDMA and LSD. (MAPS has funded studies using independently produced MDMA and psilocybin.)

"The government is basically scared of this research," says Doblin, during a break in testimony. "They want it two ways. They want to say there's not enough research to make marijuana into a medicine, and they want to block the research." Still, he feels reasonably confident that the DEA's decision might be reversed. "My sense is that the judge is fair, she's asking good questions, I have a lot of respect for the way she's interacted with us so far." Time will tell if his optimism is well-founded. There will be another week of testimony toward the end of September, and another (if need be) in December, before Judge Bittner makes a recommendation to the head of the DEA. In the meantime, Doblin will be commenting nightly on the goings-on in Washington at www.maps.org/weblogs/rick.

Sacramento Bee
August 25, 2005
Clash over pot research gets personal Vasconcellos' long-ago self-esteem panel is derided by DEA lawyer.
Michael Doyle
Bee Washington Bureau

ARLINGTON, Va. The Bush administration is using hardball and ridicule this week as it fights efforts to expand medical marijuana research.

Former California legislator John Vasconcellos caught the ridicule, with derisive inquiries into his past work on self-esteem. Others faced hardball, with questions about their pot smoking. It's all part of a high-stakes fight as a reluctant Drug Enforcement Administration reconsiders a researcher's application to grow high-quality pot.

"We're the only people in America who can't get 10 grams of marijuana," research advocate Rick Doblin testified Wednesday.

The DEA's administrative law courtroom is far from the limelight, and only about one-quarter of the spectator seats were taken Wednesday afternoon. Still, the hearing that's likely to last several more weeks is the most important legal proceeding on the issue since the Supreme Court ruled in June that federal authorities can pursue medical marijuana users in California.

That 6-3 ruling in Gonzales v. Raich did not overturn the medical marijuana provisions approved in California and other states, but it did expose users to potential federal prosecution.

It's still unclear how aggressively U.S. Attorney General Alberto Gonzales may pursue medical marijuana users. There's no question, though, that the administration disputes marijuana's potential worth as a medicine. That's what makes the new hearing so crucial, and it may also help explain some of the courtroom tactics.

After years of delay, the DEA's administrative law judge is being asked to help overturn the agency's rejection of a marijuana researcher's application first filed in 2001. University of Massachusetts plant physiologist Lyle Craker had sought approval to grow 25 pounds.

"We (look) at marijuana as we would do any other medicinal plant," Craker testified.

Craker said the limited marijuana now grown under federal supervision at a 12-acre University of Mississippi site is weak and filled with stems and seeds. Craker, the editor of the Journal of Herbs, Spices and Medicinal Plants, said his more potent pot would help test new vaporizers as a healthier means for patients to ingest the smoke.

The American Civil Liberties Union is supporting Craker's effort, as are several law firms working on a pro bono basis.

"We're not doing marijuana research because we can't seem to get marijuana," said Doblin, head of the nonprofit Multidisciplinary Association for Psychedelic Studies, "so we're spending money on litigation."
Drug enforcement officials reply that the University of Mississippi's inventory already contains some 1,500 kilograms of marijuana. Officials say that stash, combined with rolling machines that can crank out 1,000 marijuana cigarettes every minute, can more than meet existing research needs for a drug the government considers dangerous.

"Marijuana," the DEA said in court filings, "has no currently accepted medical use in treatment in the United States."

The government's existing marijuana stocks supplied scientists, for instance, at the University of California Medical Cannabis Research Center. While in the state Senate, Vasconcellos drafted the bill creating the research center.

That's why Vasconcellos was called to testify on Craker's behalf this week, but that's not what DEA attorney Imelda Paredes wanted to ask him about.

Instead, in an apparent effort to undercut the former Democratic legislator's credibility, Paredes pressed Vasconcellos on the California self-esteem task force that finished its work 15 years ago.

"Haven't research studies shown that in academic terms, self-esteem curricula are worse than useless?" Paredes asked.

Paredes also noted Vasconcellos' place in a conservative author's book titled "One Hundred People Who Are Screwing Up America."

Vasconcellos' testimony ended shortly after he defended the self-esteem programs.

On Wednesday, DEA attorney Brian Bayley took a different tack with Doblin, by pressing him repeatedly about his own marijuana use. Over his lawyer's objections, Doblin acknowledged he had begun smoking marijuana in the early 1970s and still smokes it recreationally about once a week.

Bayley then asked him who he bought his pot from; at that point, the judge said the DEA had gone far enough.

The hearing will continue through Friday and then resume next month. The administrative law judge will make a recommendation but cannot order the DEA to grant the application.

The Bee's Michael Doyle can be reached at (202) 383-0006 or mdoyle@mcclatchydc.com.

Journal of the American Medical Association
August 25, 2005
Medical Marijuana, American Federalism, and the Supreme Court
Lawrence O. Gostin, JD, LLD (Hon)

In GONZALEZ V RAICH, THE US SUPREME COURT HELD THAT federal law enforcement authorities could criminally prosecute patients for possessing marijuana prescribed by a physician in accordance with state law.1 The Court did not overturn state medical marijuana laws but did open the door to criminal prosecution under federal drug statutes. The Court also did not foreclose future challenges to federal enforcement on other constitutional grounds (eg, an unwarranted invasion of patient-physician privacy).

Explaining the significance of Raich requires examination of 2 issues. The first concerns American federalism and raises an important constitutional principle about the appropriate scope of federal public health powers. The second issue concerns the use of marijuana as a medical treatment and raises intriguing questions about the practice of medicine and the patient-physician relationship. In Raich, the Supreme Court pointedly questioned the wisdom of prosecuting patients: "The case is made difficult by respondents' strong arguments that they will suffer irreparable harm because . . . marijuana does have valid therapeutic purposes. The question before us, however, is not whether [the policy] is wise, [but] whether Congress has the power to regulate . . . medicinal substances . . . produced and consumed locally."

Gonzalez v Raich.
California's Compassionate Use Act of 1996 (enacted by Proposition 215) was designed to ensure that "seriously ill" residents have access to marijuana for medical purposes to relieve suffering. The act exempts physicians, patients, and primary caregivers from criminal prosecution for possessing or cultivating marijuana for medicinal purposes with a physician's approval. Notably, the act states that physicians shall not be "punished, or denied any right or privilege, for having recommended marijuana to a patient for medical purposes."2 Ten additional states - Alaska, Arizona, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Washington, and Vermont - allow use of marijuana for medical purposes.

Angel Raich and Diane Monson (respondents) use marijuana prescribed by board-certified family physicians who concluded that it is the only drug that provides effective treatment. Ms Raich has an inoperable brain tumor and wasting syndrome, and Ms Monson has a degenerative spine condition with chronic back pain. On August 15, 2002, county sheriffs and Drug Enforcement Administration (DEA) agents went to Ms Monson's home: the sheriffs found her use of marijuana to be entirely lawful, but the federal agents seized and destroyed all 6 of her cannabis plants. The respondents sued to prohibit the enforcement of the federal Controlled Substances Act (CSA).3

The CSA, enacted in 1970 as part of President Nixon's "war on drugs," regulates controlled substances. Marijuana, together with heroin and LSD (lysergic acid diethylamide), are classified as schedule I drugs based on the following findings: the high potential for abuse, no accepted medical use, and no accepted safety for use in medically supervised treatment. Marijuana, therefore, is strictly criminally prohibited except as part of a research study preapproved by the US Food and Drug Administration (FDA).4 The US attorney general has routinely denied petitions to reclassify marijuana,5,6 despite a ruling from Administrative Law Judge Francis Young that "it is unreasonable, arbitrary, and capricious for DEA to continue to stand between sufferers and the benefits of this substance in light of the evidence."7,8

In Raich, the Supreme Court held that Congress' authority to regulate interstate commerce includes the power to prohibit local cultivation and use of marijuana approved by a physician and in compliance with California law. Congress' power to regulate purely local activities that are part of an economic "class of activities" that have a substantial effect on interstate commerce is firmly established, Justice Stevens wrote. The Court found "striking similarities" between this case and a 1942 case that upheld a federal prohibition on a farmer growing wheat for his own consumption9: "Like the farmer, respondents are cultivating, for home consumption, a fungible commodity for which there is an established, albeit illegal, interstate market." The Court said that its prior decisions, striking down the federal Gun-Free School Zones Act10 and the federal Violence Against Women Act11 on the ground that those laws exceeded congressional authority, were read "far too broadly." The 6-3 decision in Raich revealed a fissure within the coalition on the Rehnquist Court that over the past decade has curtailed federal power and safeguarded state sovereignty.

American Federalism: Protection of Health, Safety, and Welfare
American federalism, the most basic constitutional arrangement, has become a hallmark of the Rehnquist Court.12 Federalism is a form of governance in which states cede certain powers (eg, foreign affairs and interstate commerce) to a national government while retaining most other aspects of sovereignty. Ever since the nation's founding, the political community has differed on whether the powers delegated to the federal government are, as James Madison said, "few and defined" or, as Alexander Hamilton argued, more expansive.13 In this debate, the Rehnquist Court usually has taken a "states rights" position, protecting spheres of state sovereignty from federal encroachment.

Medical marijuana exemplifies the role of states as laboratories for innovative solutions to the most intractable problems, where "a single courageous State may . . . try novel social and economic experiments without risk to the rest of the country."14 Justice O'Connor, dissenting in Raich, lamented that the Court had extinguished an experiment on the difficult and sensitive question of whether marijuana should be available to relieve severe pain and suffering. The Supreme Court will soon decide the fate of another social experiment - whether the state of Oregon may legalize physician-assisted suicide.15

Although states should be free to be inventive in the face of difficult social problems, this ought not negate federal authority to set national standards for health protection. The Rehnquist Court's federalism jurisprudence rarely has protected innovative state experiments but rather has simply repudiated federal health and safety regulation. Not only has the Court thwarted federal regulation of firearms10 and violence against women,11 but it has also struck down environmental regulation16 and antidiscrimination legislation.17 Barely a week after Raich was decided, the Court refused to hear federalism cases involving such key public health issues as federal authority over endangered species and homemade machine guns, suggesting perhaps that the Rehnquist Court's federalism revolution is on the wane.

Affirming federal constitutional power to safeguard the public's health and safety is vital to the population's well-being. It is important to remember that citizens have historically turned to federal authority in times of hardship to create equality before the law, protect workers from injury, safeguard the environment, provide social security, and finance health care for poor and elderly persons. The next time the Supreme Court hears a federal-powers case relating, for example, to pollution, occupational safety, or nondiscrimination, it ought to be guided by its decision in Raich. In this sense, the Court's possible retreat from strict federalism may ultimately advance protection for people and the environment.

Medical Marijuana: Evidence-Based Health Policy
The use of marijuana for medicinal purposes touches on ethical problems with significant implications for health care and public health. Sound policy requires regulatory oversight based on public health, a rigorous research agenda, a private patient-physician relationship, and relief of patient suffering.

Public Health Regulation.
Medical marijuana ideally should be regulated by a specialized health agency using the best available scientific evidence and having a strong research agenda. "Medicine by regulation is better than by referendum," said Justice Breyer during oral arguments.18 Marijuana need not necessarily be subject to the same kind of preapproval drug evaluation as other prescription medications because of the legal and cultural differences. However, a rational system based on science should be in place.

Current federal regulation of marijuana is flawed. The CSA is not an appropriate model for regulating drugs with potential medical benefits. It primarily addresses enforcement of drug laws, not clinical practice and research. The Supreme Court has unanimously ruled that there is no medical necessity exception to the CSA's prohibitions on marijuana. "The statute reflects a determination that marijuana has no medical benefits worthy of an exception," wrote Justice Thomas.4 The agencies responsible for medical marijuana, moreover, have conflicting missions: law enforcement (DEA), prevention of drug abuse and addiction (National Institute of Drug Abuse [NIDA]), and public health (FDA).

Research.
The Institute of Medicine found that "scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC[tetrahydrocannabinol], for pain relief, control of nausea and vomiting, and appetite stimulation."19 Yet research has been sporadic, with the federal apparatus posing multiple hurdles to scientists. The FDA must approve research on scientific grounds and an institutional review board must approve on ethics grounds. The only legal source of marijuana is a farm in Mississippi run by NIDA. As gatekeeper of the supply, NIDA must also approve the research project. The marijuana supplied by the NIDA facility lacks purity and strength, depriving researchers of a stable source of raw material.20 Once a study is approved, the DEA monitors distribution of marijuana to physicians and patients and requires tight security (eg, locked safes, adequate ventilation, secure transportation, and accurate scales to weigh the arriving and dispensed product). Since the mission of NIDA does not include development of marijuana as a prescription medicine, private funding sources are required. To objectively answer the questions about the efficacy and safety of marijuana, the federal government must be open to the results of scientific research.

Patient-Physician Relationship.
Federal drug policy chills clinical judgment relating to marijuana. Agency officials have sought to punish physicians who prescribe marijuana by excluding them from the Medicare program and suspending or revoking their registration to prescribe restricted drugs. They have threatened prosecution of physicians and their patients for supplying or possessing marijuana.21 The Ninth Circuit Court of Appeals held that punishing physicians for recommending marijuana "strikes at core First Amendment interests" because "an integral component of the practice of medicine is the communication between a doctor and a patient."22 Physicians must be able to speak frankly and openly with patients to gain their trust and to accurately diagnose and treat disease.

Relief of Suffering.
The prime objective of medical marijuana is to relieve patient suffering. Seriously or terminally ill patients have an abiding interest in living with dignity by having the highest possible quality of life. Marijuana use may help relieve the symptoms of illness and lessen the adverse effects of conventional treatments such as chemotherapy.19 Perhaps the greatest public concern with strict federal enforcement of drug restrictions is the perception that it denies patients needed relief.

Sound Regulation of Medical Marijuana.
Sound regulation of medical marijuana requires government oversight based on public health, a rigorous research agenda, a private physician-patient relationship, and respect for patients who seek relief from suffering. A first step would be to reclassify marijuana as a schedule II drug because, like the schedule II substances cocaine and morphine, it fits well within the statutory definition of having "a high potential for abuse” but “a currently accepted medical use with severe restrictions."23 This would allow for medical prescriptions subject to strict regulation without unduly interfering with federal drug policy. Allowing restricted access to marijuana for seriously ill patients would not necessarily send a "soft" or "wrong" message about drug abuse. The public can make a distinction between a drug of abuse and a drug prescribed by a physician for a compassionate purpose. The data suggest that marijuana may offer respite for some patients—a position supported by patient experiences and physician opinions. The "drug war" metaphor does not justify an ideology that removes hope from patients when they are most vulnerable and in need.

Financial Disclosures: None reported.

References
1. Gonzalez v Raich,125 SCt 2195 (2005).
2. Cal Health & Safety Cod Ann §11362.5(d) (West 2005).
3. Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 USC 801
et seq.
4. United States v Oakland Cannabis Buyers’ Cooperative, 532 US 483, 490 (2001).
5. 66 Federal Register, 20,038 (2001).
6. Alliance for Cannabis Therapeutics v DEA,15 F3d 1131, 1133 (DC Cir 1994).
7. Grinspoon v DEA, 828 F2d 881, 883-884 (1st Cir 1987).
8. IsikoffM. Administrative law judge urges medicinal use of marijuana: DEA expected
to reject call for limited legalization. Washington Post. September 7, 1988;
sect 1:A2.
9. Wickard v Filburn, 317 US 111 (1942).
10. United States v Lopez, 514 US 549 (1995).
11. United States v Morrison, 529 US 598 (2000).
12. Greenhouse L The Rehnquist Court and its imperiled states’ rights legacy.
New York Times. June 12, 2005;sect 4:3.
13. Madison J. Federalist No. 45. In: Rossiter C, ed. The Federalist Papers. New
York, NY: New American Library; 1961:292-293.
14. New State Ice Co v Liebmann, 285 US 262, 311 (1932) ( J. Brandeis, dissenting).
15. Oregon v Ashcroft, 368 F3d 1118 (9th Cir 2004), cert granted sub nom, Gonzalez
v Oregon, 125 SCt 1299 (2005).
16. New York v United States, 505 US 144 (1992).
17. University of Alabama v Garrett, 531 US 356 (2001).
18. Oral Argument, US Supreme Court Official Transcript at 50, Gonzalez v Raich,
125 SCt 2195 (2005). No. 03-1454.
19. Institute of Medicine. Marijuana and Medicine: Assessing the Science Base.
Washington, DC: National Academy Press; 1999.
20. Satel S Good to grow. New York Times. June 8, 2005;sect 4:3.
21. Steinbrook R. Medical marijuana, physician-assisted suicide, and the controlled
substances act. N Engl J Med. 2004;351:1380-1383.
22. Conant v Walters, 309 F3d 629 (9th Cir 2002), cert denied, 540 US 946 (2003).
23. Kassirer JP. Federal foolishness and marijuana. N Engl J Med. 1997;336:
366-367.

Duluth News Tribune
August 23, 2005
Professor appeals rejection of pot research
Elise Waxenberg
Hearst Newspapers

WASHINGTON -- A Massachusetts professor on Monday appealed a decision by the U.S. Drug Enforcement Administration barring him from growing marijuana for medical research.

A Massachusetts professor on Monday appealed a decision by the U.S. Drug Enforcement Administration barring him from growing marijuana for medical research.

Lyle Craker, a plant and soil sciences professor at the University of Massachusetts at Amherst, testified that he had first applied to the DEA for a permit to grow 25 pounds, dry weight, of medical marijuana in 2001.

After more than eight months without a response from the agency, Craker said he contacted the DEA and was first told that his application had not received, and then that the forms had not been filled out correctly. After filing again, Craker was visited twice by DEA agents who, he said, tried to "discourage the university" from carrying out the project on the basis that it would harm the institution's reputation.

Craker told administrative law judge Mary Ellen Bittner that he was a faculty member of a public university and thus felt a responsibility "to do the best that I can for the citizens of the Commonwealth of Massachusetts and certainly for the United States -- they're paying my salary."

Craker, who is an expert on medicinal plants, continued: "That means exploring all of the options that are available for uses of plant material as medicine."

Craker's lawyers were joined by the American Civil Liberties Union in the appeal. ACLU attorney Allen Hopper later told a news conference that the federal government monopolizes the supply of marijuana available for research and that the DEA's refusal to license Craker represents a government effort to prevent marijuana from eventually being approved as a prescription drug.

Currently, the federal National Institute on Drug Abuse controls the only legal supply of marijuana available for clinical studies. The ACLU argues that the institute will only allow scientists to purchase its marijuana for research aimed at discovering harmful effects of the drug but refuses access to scientists studying its therapeutic benefits.

Several phases of clinical trials are necessary for any substance to be approved by the federal Food and Drug Administration as a prescription drug.

The New Standard
August 23, 2005
Medical Marijuana Hearings Begin
Brendan Coyne

A hearing into a challenge to federal laws prohibiting research and experimentation with marijuana opened today, with the American Civil Liberties Union charging that the Drug Enforcement Agency's efforts to fight such privately-funded research posed an unnecessary obstruction that could prevent researchers from definitively finding out whether the plant has legitimate medical uses.

The proceedings cap a four-year battle by a University of Massachusetts professor seeking to grow marijuana for research into the prohibited plant's medicinal uses. Through its Drug Law Reform Project, the ACLU is representing the plant researcher, Lyle E. Craker, in front of a Department of Justice administrative law judge who will make recommendations to the Drug Enforcement Agency (DEA).

Craker, who heads the Medicinal Plant Program at the University of Massachusetts/Amherst is fighting a 2004 DEA final denial of his request for a permit to grow marijuana for research. He first sought approval in 2001, according to pre-hearing papers.Currently all marijuana used for research must come from a Mississippi farm contracted by the National Institute on Drug Abuse. The DEA has said no more sources for research plants are needed.Proponents of Craker's proposal have said that supply from Mississippi has been inconsistent and the potency of the drug questionable.In addition,

DEA officials expressed concern that the professor's growing operation would lack proper supervision to prevent misuse or theft of the plants.Craker, the ACLU and medical marijuana research supporters claim the federal restrictions prevent independent research, stifling scientific and medical inquiry. They have also pointed out that by preventing study on the medicinal benefits of the plant, the DEA has "slammed the door" on efforts to gain approval of the drug from the Food and Drug Administration.

Family News in Focus
August 23, 2005
ACLU Wants DEA Approval for Marijuana Research
Bill Wilson

The Drug Enforcement Administration is being sued by the American Civil Liberties Union because, according to the ACLU, the government will not supply marijuana for research to see if it's appropriate for medicinal purposes. The advertised goal of the suit is to force the government into allowing a commercial enterprise to grow marijuana for research.

ACLU witness, Richard Doblin of the Multidisciplinary Association for Psychedelic Studies. "Our goal is specifically to make marijuana into an FDA approved prescription medicine. No Drug development can really take place until we get our own independent source of supply."

Doblin charges that the government is not interested in medical marijuana research. "They will fund research into the risks of marijuana, but they will not fund research into the benefits. And the major foundations are still reluctant to such a controversial area as medical marijuana."

Dr. Gene Rudd of the Christian Medical and Dental Association says there is good reason medical marijuana is not available to the public: "We don't make these available because we have better products that can be used more safely. And until research shows, which I don't see any evidence that it's going to, that these are superior and safer than what we are currently using, there is no need to make medical marijuana available."

While nobody in the ACLU camp is saying it, this appears to be a back door attempt to legalize marijuana.

The National Institute on Drug Abuse estimates that marijuana is the most commonly used drug in the US. About half of America 's teenagers try marijuana before finishing high school.