Arrested development: The case for studying medical marijuana

If there were a drug with the potential to alleviate the pain and suffering of the sickest patients, for whom all other treatments have failed, should patients be allowed to use it? Should independent medical researchers be able to study it? Should physicians be able to prescribe it?

What if that drug was marijuana?

Frustrated doctors and scientists say that in marijuana's case, the federal government's answer is no.

Classified by the Drug Enforcement Administration as a Schedule I controlled substance, cannabis can be researched as a medicine only with federal approval. The National Institute on Drug Abuse controls the supply for U.S. studies.

Although physicians debate the likely value of marijuana as medicine, they agree that, unlike other drugs with therapeutic potential, the government has taken a controlling interest in it. This has hindered the research necessary to find out whether cannabis can effectively help patients with serious medical conditions.

The Food and Drug Administration, DEA and NIDA declined to comment. But the FDA in April issued a statement reiterating its position that "no sound scientific studies support medical use of marijuana for treatment in the United States."

Still, states continue to pass laws allowing its use with a doctor's recommendation, in spite of an overriding federal ban on the drug's prescription and use. The disconnect between federal and state laws poses risks to both doctors and patients, physicians say. It's time, they add, to expand research and resolve the issue so they can exercise control in the care of patients who seek marijuana for medicinal purposes.

Dangers for doctors and patients

"It would be helpful if we did the standard rigorous studies needed instead of having to wander in the dark," said California Medical Assn. President Michael J. Sexton, MD. California in 1996 became the first state to make it legal for patients with specific, debilitating illnesses to grow and possess small amounts of marijuana with a doctor's recommendation. Rhode Island's passage of a law in January brought the number of states allowing medical marijuana to 11.

In those states, most medical societies, like the CMA, have not taken a position on the statutes or whether the drug has medicinal value. Organized medicine's main concern has been protecting the doctor-patient relationship and doctors' right to openly discuss the substance as a treatment option without fear of prosecution or loss of their medical licenses.

In 2003, doctors won a small victory when the U.S. Supreme Court declined to change a 9th U.S. Circuit Court of Appeals decision reinforcing this privacy, even when it involves conversations about cannabis. However, patients are left unprotected because the court in 2005 concluded that, regardless of state laws, the federal government has the right to arrest patients for marijuana possession.

Frank H. Lucido, MD, treated Angel McClary Raich, one of the people who brought the case that was decided last year. He recommended cannabis to alleviate Raich's chronic pain caused by an inoperable brain tumor and severe scoliosis, among other ailments.

The court's ruling in Raich's case could also put physicians in a precarious situation, Dr. Lucido warned. When discussing the substance, doctors must be cautious "not to be perceived as aiding or abetting patients in obtaining cannabis," he said.

A family physician in Berkeley, Calif., Dr. Lucido said he was investigated by the state medical board in 2002 for recommending marijuana to a patient, although the case was closed with no charges filed. Since then, he has advocated and testified for other doctors investigated by state authorities despite California's medical marijuana law.

Anecdotally, doctors say, the DEA has not pursued them or patients. Nonetheless, risks remain. Some of those dangers aren't legal but medical.

"It makes physicians uneasy that they can't supervise or have some sort of control over what their patients are doing," said Lynn Parry, MD, president-elect of the Colorado Medical Society. A neurologist, Dr. Parry said she has recommended medicinal marijuana to patients with chronic pain, but on a limited basis when other remedies have failed.

Doctors also worry because they can't be sure of the drug's quality. Even with a doctor's certification, a 2000 Supreme Court ruling bars the distribution of marijuana for any purposes, including medical, so patients still have to obtain the drug illegally under state legislation.

The Maine Medical Assn. opposes its state medical marijuana law because the statute puts patients in jeopardy at the federal level.

"It's a bizarre law because nothing else happens in a doctor's office where you get a prescription and then have to go out and break the law to acquire the drug," said MMA Executive Vice President Gordon H. Smith.

Doctors debate

Organized medicine has not taken a stance on the FDA's recent conclusions. But Dr. Lucido is one of many physicians who believe the agency's statement that marijuana has no medical value contradicts a 1999 review by the Institute of Medicine, part of the National Academy of Sciences.

The IOM concluded that "for patients such as those with AIDS or who are undergoing chemotherapy and who suffer simultaneously from severe pain, nausea and appetite loss, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication."

American Medical Association policy calls for further adequate clinical research to determine whether marijuana and related cannabinoids are effective in treating patients with serious conditions for which pre-clinical and anecdotal evidence suggests efficacy.

Without adequate research, doctors are left trying to sort out on their own whether the drug's possible benefits outweigh its hazards. With the National Institute on Drug Abuse in control of the supply, doctors and scientists are concerned the government has actively discouraged the privately funded or academic research typically conducted to test new drugs.

The FDA maintains that state measures legalizing medicinal marijuana use are "inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process." However, at the same time, "the federal government has really blocked research since it is the only one who controls studies," Dr. Lucido said.

No privately funded research has taken place, and a leading study at the University of California's Center for Medicinal Cannabis Research is the only state-funded one, with some NIDA grants, according to the Marijuana Policy Project, a nonprofit group that supports the drug's medical use. A recent NIDA-supported study conducted at the David Geffen School of Medicine at the University of California, Los Angeles found that marijuana did not increase the risk for lung, neck or head cancer.

Scientist Lyle E. Craker, PhD, a professor in the department of plant and soil sciences at the University of Massachusetts at Amherst, said that his efforts to promote research have been stalled. Last December, Dr. Craker appealed the DEA's rejection of his 2001 application to grow an alternative supply so that privately funded clinical trials can be started. A decision on the appeal is expected this summer.

"There is lots of lay evidence supporting the medical benefits, but the science of it is quite lacking," he said. Dr. Craker said he visited with a group of about six patients who are participating in the California study. He said the patients criticized the poor quality and effectiveness of the drug.

"What we are trying to do is produce a standardized source so that we can have an honest evaluation of it," Dr. Craker said.

Addiction medicine specialist Andris Antoniskis, MD, also would like to see more than just anecdotal evidence. He suspects research would confirm the potential risks associated with smoking cannabis. No other inhaled medicines containing carcinogens are approved by the FDA, he notes.

"The addiction medicine community strongly feels that marijuana is a misunderstood public health threat that certainly can produce significant dependence and other health issues," said Dr. Antoniskis, who is president of the Oregon Medical Assn. In Oregon, more than 10,000 patients have registered to use the drug under the state law, and more than 2,000 physicians have certified their qualifying medical conditions, according to the Oregon Dept. of Human Services.

Until the science is solid, he pointed out, there are regulated alternatives, such as Marinol (dronabinol). The pill contains a synthetic version of tetrahydrocannabinol and is approved by the FDA to treat anorexia associated with AIDS and nausea and vomiting associated with chemotherapy for patients who fail to respond to other antiemetics.

Still, Dr. Antoniskis said, "this is enough of a public issue that we need to prove or disprove its legitimate medical uses, and research should be expanded to resolve the issue."

A category of its own

As for why marijuana is getting separate treatment when compared with other controlled drugs, doctors say that politics is the reason. It is interfering with an issue they view as best left to the scientific and medical communities. For example, some doctors point to the DEA's view that marijuana is a "gateway" drug that can lead to the abuse of other hard substances. They say this stance is unwarranted in the absence of conclusive studies.

HIV medicine specialist Robert Killian, MD, MPH, says that the government's "war" on pain medications in general has derailed exploration of legitimate medical use of marijuana. He said he has seen the drug help a number of patients.

"There are worse things out there with lots of side effects," said Dr. Killian, who practices in Seattle and who helped draft Washington's law. Yet without any relevant scientific data, the FDA has classified marijuana as a Schedule I controlled substance, above Schedule II drugs like morphine and oxycodone, which are also abused, he added.

Another political obstacle that doctors say has diverted productive discussion is the advocacy effort for wholesale legalization of the drug, which most physicians oppose. The issue "tends to raise some questions in whether there is really a medical purpose in it or is somebody attempting to hijack the medical system to legitimize substance abuse," Oregon's Dr. Antoniskis said.

The best way to keep politics out of the doctor-patient relationship in this medical marijuana debate is for the FDA to set politics aside and make a more concerted effort to study it, doctors say.

"It's a good thing other countries are doing research," said California's Dr. Lucido. Sativex, a vaporized form of natural cannabis, was approved last June for prescription use in Canada to treat neuropathic pain in patients with multiple sclerosis. The drug's British manufacturer, GW Pharmaceuticals, indicated this March that it received FDA approval to begin a U.S. clinical trial of Sativex for cancer patients later this year. The company is also developing a portfolio of other cannabis medicines.

"We are looking at something that has a rising potential in health care, and if you can have something available that is relatively safe and cheap and that can be controlled, it would seem important to make some rational policy decision based on evidence in medicine rather than philosophy," Colorado's Dr. Parry said.