The months of recalls and warnings surrounding popular prescription painkillers have done more than frighten consumers, batter drug makers' bottom lines and raise questions about the procedures and criteria by which the Food and Drug Administration approves medications.
The fact that so many legal drugs pose serious health risks is also reigniting a debate over the medicinal value of other substances — illegal drugs, particularly marijuana — and what critics believe is the government's continuing resistance to studying their possible benefits.
Frustrated researchers say the question is not whether marijuana could serve legitimate medical purposes. Marijuana has been looked at for a variety of medical applications. It can relieve intraocular pressure caused by glaucoma , and it has been touted as an appetite stimulant for patients undergoing chemotherapy, suffering from AIDS wasting syndrome or dementia.
More recently, it has been looked at to relieve the neuropathic pain — the so-called "phantom pain" — of patients with multiple sclerosis.
The question, researchers say, is whether the benefits of marijuana outweigh the risks of its negative side effects, or whether the maladies can be better treated by other drugs. That's the very question the FDA used to evaluate Vioxx, Bextra and Celebrex, and one that researchers say the government won't let them answer about marijuana.
"I honestly think they're looking at my age and they’re hoping that if they wait a little bit longer, I’ll be retired and someone will have to start this process all over again," said Lyle Craker, 64, director of the Medicinal Plant Program at the University of Massachusetts, who has been trying to get government approval to produce marijuana for federally approved studies since 2001.
Why Not Pot?
After years of steadfast refusals, the federal government has been slowly easing restrictions on pharmaceutical research into the medical benefits of some of the country’s most abused recreational drugs. In 2004, the FDA approved two separate studies into medicinal uses of MDMA — also known as the psychedelic party drug Ecstasy.
A clinical trial at Harvard University will examine whether MDMA can help terminally ill cancer patients talk to their families about their illness and ultimate death. A psychiatrist in South Carolina is studying the drug's effects on women who are victims of rape or other sexual assaults in a private study.
But researchers who want to study the nation's most abused recreational drug — marijuana — are still in last place in the research race. Many researchers blame government bureaucracy and the conflicting missions of different government agencies that make obtaining marijuana for medical research nearly impossible.
"The FDA has approved marijuana studies and, if it were possible to get marijuana in order to conduct the studies, there would be a lot more research proposed and the FDA would approve more," said Steve Fox, director of government relations for the Marijuana Policy Project, a lobbying group that seeks to legalize medical marijuana and reform drug-related crime laws. "Our problem is that the [Drug Enforcement Agency] is blocking effective research from moving forward."
Dr. John Halpern, the psychiatrist who is heading up Harvard University's study of MDMA's effects on anxiety in dying cancer patients, said that the government's system for distributing marijuana for medical use creates difficult hurdles for researchers.
For example, the MDMA Halpern is using in his study is produced by companies that are contracted by the government, and given the appropriate licenses, to do so. The job of contracting and overseeing the production of cannabis for the government, however, is the domain of the National Institute on Drug Abuse. But critics say the NIDA has a conflict of interest because its mission is to prevent the use of marijuana regardless of the purpose.
"[NIDA's] mission statement isn’t to look into any therapeutic effect from the drug of abuse, it’s to look into the harms," Halpern said. "So [they see the marijuana it controls as being] diverted to a non-NIDA funded study, and NIDA has that marijuana earmarked for more important things from their perspective."
Like Ecstasy, marijuana is classified as a Schedule I drug under the 1970 Controlled Substance Act, a group that includes heroin and LSD, and has been deemed by the government to have no medical benefit and to be highly addictive. But unlike other Schedule I drugs, which can be obtained through government-licensed contractors, marijuana can be legally obtained for research only from the NIDA.
Craker filed his application to produce medical marijuana for federally approved studies in 2001. He finally received a rejection in 2004, despite strong showings of support from Senators John Kerry, D-Mass., and John Edwards, D-N.C.
"The DEA is attempting to follow their mandate, which I am sure is to keep marijuana off the streets for recreational use and they're doing the best they can there," Craker said. "They think the medical marijuana we produce would be for street use, which is not true, but I think that’s their opinion."
Craker and other researchers frustrated by the government's handling of medical marijuana research applications filed a suit against the DEA and the National Institute on Drug Abuse in July of 2004.
The FDA, DEA and Department of Health and Human Services declined to comment for this story.
Of course, researchers like Halpern emphasize that the scheduling system was put in place with the intentions of protecting the public from junk science studies and keeping illicit drugs away from the public. But advocates for the research say political pandering, corporate greed and the power and influence of the pharmaceutical industry corrupt the system. The race to bring new drugs to the market is not only concerned with the health of the populace, they say, but also with the health of drug companies' stock portfolios, and a drug that patients can produce and use without their help is not good for drug makers' bottom line.
"The federal government sits by while the FDA approves Vioxx, which leads to the death of many people, while marijuana in its history has never caused an overdose death," argues Fox.
Greg Lewis, co-author of the self-help book "End Your Addiction Now," says that with the pharmaceutical industry spending $38.8 billion on research and development in 2004, medical marijuana is superceded by drugs produced through proprietary research.
Lewis, however, is skeptical that research into medical marijuana amounts to much more than backdoor legislation for groups whose real agenda is legalizing the drug across the board.
"With just an absolute cornucopia of pharmacological substances out there for the purposes of dulling pain and making pain tolerable, it’s unimaginable to me that marijuana would be the only way that certain people can get relief from their pain," Lewis said.
A Controversial History
Controversy surrounding the medical benefits of marijuana dates back to 1937, when cannabis was officially prohibited by the federal government. Prior to that, THC, the active ingredient in pot, was used in at least 27 legal medications and was one of the primary ingredients in commercial painkillers until the commercial production of aspirin began in 1899.
Since it was outlawed by the feds, government opposition has largely prohibited research into the medical efficacy of marijuana. But interest in its medicinal potential was rekindled in the 1990s, when anecdotal reports surfaced that marijuana helped treat the nausea, loss of appetite and chronic pain suffered by AIDS patients.
In 1997, the FDA, in conjunction with the DEA, gave researchers at the University of California the OK to perform the first medical marijuana study in 15 years.
Currently there are 13 clinical studies and sub-studies of medical marijuana underway in the U.S., according to the Center for Medicinal Cannabis Research.
The U.S. drug company Indevus, based in Lexington, Mass., is testing a pain reliever derived from marijuana that lacks the psychotropic effects of the smoked plant.
More research is moving forward overseas. A British company, GW Pharmaceuticals, is on the verge of getting the Canadian government’s stamp of approval to market a marijuana-based mouth spray to treat nerve pain experienced by multiple sclerosis patients.
And trials of a synthetic marijuana-derived painkiller, ajulemic acid, are going ahead in France and Germany.
But in the U.S., the research still faces a steep uphill battle, not likely to be helped along by the resounding defeat voters in several states delivered to ballot initiatives to decriminalize marijuana in 2004. A March 2005 report by the Substance Abuse and Mental Health Services Administration showing a rising trend in the number of people seeking treatment for marijuana addiction is not likely to benefit research advocates either.
Meanwhile, the government is waging its war on drugs as vigorously as ever, and no one expects the government to revise its position on pot.
Yet, some troops who have returned from the front lines of the drug war are doing just that.
Jack Cole, a 26-year veteran of the New Jersey state police who served 14 of those years in the narcotics bureau, now serves as director of Law Enforcement Against Prohibition, a lobbying group of former drug-busters who believe the U.S. "war on drugs" has failed and supports sweeping reforms of the nation's drug policy.
Cole contends that scheduling creates a system that discourages objective research into drugs and their medical effects.
"There are certainly enough people out there who are already using Schedule I drugs [for medical purposes], who would benefit from being in a government study of their use," Cole said. "Thousands of people who are using marijuana medicinally are being labeled 'criminal' because the government refuses to allow these studies."