You can’t get more mainstream in the media than The New York Times and Wall Street Journal, who both highlight the growing medical acceptance of medical cannabis and the uber-political conditions placed on medical researchers who want to conduct rigorous scientific studies on cannabis’ medical efficacy and safety.
RESEARCHERS FIND STUDY OF MEDICAL MARIJUANA DISCOURAGED
by Gardiner Harris
January 19, 2010
Despite the Obama administration’s tacit support of more liberal state medical marijuana laws, the federal government still discourages research into the medicinal uses of smoked marijuana. That may be one reason that — even though some patients swear by it – — there is no good scientific evidence that legalizing marijuana’s use provides any benefits over current therapies.
Lyle E. Craker, a professor of plant sciences at the University of Massachusetts, has been trying to get permission from federal authorities for nearly nine years to grow a supply of the plant that he could study and provide to researchers for clinical trials.
But the Drug Enforcement Administration — more concerned about abuse than potential benefits — has refused, even after the agency’s own administrative law judge ruled in 2007 that Dr. Craker’s application should be approved, and even after Attorney General Eric H. Holder Jr. in March ended the Bush administration’s 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.
The measure was pushed by a loose coalition of patients suffering from chronic illnesses like Lou Gehrig’s disease and multiple sclerosis who said marijuana eased their symptoms.
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 marijuana’s 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. Braverman’s 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 nation’s adults regularly take supplements; herbal and homeopathic remedies are popular.
The nation’s growing embrace of medical marijuana has stemmed from these alternative traditions.
The University of Mississippi has the nation’s 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 NIDA’s 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 e-mail.
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.
“It’s not a great drug,” he said, “but what’s the harm?”
* * * * * * * * * * *
IS MARIJUANA A MEDICINE?
by Anna Wilde Mathews, (Source:Wall Street Journal)
19 Jan 2010
Share This Article
Charlene DeGidio never smoked marijuana in the 1960s, or afterward. But a year ago, after medications failed to relieve the pain in her legs and feet, a doctor suggested that the Adna, Wash., retiree try the drug.
Ms. DeGidio, 69 years old, bought candy with marijuana mixed in. It worked in easing her neuropathic pain, for which doctors haven’t been able to pinpoint a cause, she says. Now, Ms. DeGidio, who had previously tried without success other drugs including Neurontin and lidocaine patches, nibbles marijuana-laced peppermint bars before sleep, and keeps a bag in her refrigerator that she’s warned her grandchildren to avoid.
“It’s not like you’re out smoking pot for enjoyment or to get high,” says the former social worker, who won’t take the drug during the day because she doesn’t want to feel disoriented. “It’s a medicine.”
For many patients like Ms. DeGidio, it’s getting easier to access marijuana for medical use. The U.S. Department of Justice has said it will not generally prosecute ill people under doctors’ care whose use of the drug complies with state rules. New Jersey will become the 14th state to allow therapeutic use of marijuana, and the number is likely to grow. Illinois and New York, among others, are considering new laws.
As the legal landscape for patients clears somewhat, the medical one remains confusing, largely because of limited scientific studies. A recent American Medical Association review found fewer than 20 randomized, controlled clinical trials of smoked marijuana for all possible uses. These involved around 300 people in all–well short of the evidence typically required for a pharmaceutical to be marketed in the U.S.
Doctors say the studies that have been done suggest marijuana can benefit patients in the areas of managing neuropathic pain, which is caused by certain types of nerve injury, and in bolstering appetite and treating nausea, for instance in cancer patients undergoing chemotherapy. “The evidence is mounting” for those uses, says Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.
But in a range of other conditions for which marijuana has been considered, such as epilepsy and immune diseases like lupus, there’s scant and inconclusive research to show the drug’s effectiveness. Marijuana also has been tied to side effects including a racing heart and short-term memory loss and, in at least a few cases, anxiety and psychotic experiences such as hallucinations. The Food and Drug Administration doesn’t regulate marijuana, so the quality and potency of the product available in medical-marijuana dispensaries can vary.
Though states have been legalizing medical use of marijuana since 1996, when California passed a ballot initiative, the idea remains controversial. Opponents say such laws can open a door to wider cultivation and use of the drug by people without serious medical conditions. That concern is heightened, they say, when broadly written statutes, such as California’s, allow wide leeway for doctors to decide when to write marijuana recommendations.
But advocates of medical-marijuana laws say certain seriously ill patients can benefit from the drug and should be able to access it with a doctor’s permission. They argue that some patients may get better results from marijuana than from available prescription drugs.
Glenn Osaki, 51, a technology consultant from Pleasanton, Calif., says he smokes marijuana to counter nausea and pain. Diagnosed in 2005 with advanced colon cancer, he has had his entire colon removed, creating digestive problems, and suffers neuropathic pain in his hands and feet from a chemotherapy drug. He says smoking marijuana was more effective and faster than prescription drugs he tried, including one that is a synthetic version of marijuana’s most active ingredient, known as THC.
The relatively limited research supporting medical marijuana poses practical challenges for doctors and patients who want to consider it as a therapeutic option. It’s often unclear when, or whether, it might work better than traditional drugs for particular people. Unlike prescription drugs it comes with no established dosing regimen.
“I don’t know what to recommend to patients about what to use, how much to use, where to get it,” says Scott Fishman, chief of pain medicine at the University of California, Davis medical school, who says he rarely writes marijuana recommendations, typically only at a patient’s request.
Researchers say it’s difficult to get funding and federal approval for marijuana research. In November, the AMA urged the federal government to review marijuana’s position in the most-restricted category of drugs, so it could be studied more easily.
Gregory T. Carter, a University of Washington professor of rehabilitation medicine, says he’s developed his own procedures for recommending marijuana, which he does for some patients with serious neuromuscular conditions such as amyotrophic lateral sclerosis, or Lou Gehrig’s disease, to treat pain and other symptoms. He typically urges those who haven’t tried it before to start with a few puffs using a vaporizer, which heats the marijuana to release its active chemicals, then wait 10 minutes. He warns them to have family nearby and to avoid driving, and he checks back with them after a few days. Many are “surprised at how mild” the drug’s psychotropic effects are, he says.
States’ rules on growing and dispensing medical marijuana vary. Some states license specialized dispensaries. These can range from small storefronts to bigger operations that feel more like pharmacies. Typically, they have security procedures to limit walk-in visitors.
At least a few dispensaries say they inspect their suppliers and use labs to check the potency of their product, though states don’t generally require such measures. “It’s difficult to understand how we can call it medicine if we don’t know what’s in it,” says Stephen DeAngelo, executive director of the Harborside Health Center, a medical-marijuana dispensary in Oakland, Calif.
Some of the strongest research results support the idea of using marijuana to relieve neuropathic pain. For example, a trial of 50 AIDS patients published in the journal Neurology in 2007 found that 52% of those who smoked marijuana reported a 30% or greater reduction in pain. Just 24% of those who got placebo cigarettes reported the same lessening of pain.
Marijuana has also been shown to affect nausea and appetite. The AMA review said three controlled studies with 43 total participants showed a “modest” anti-nausea effect of smoked marijuana in cancer patients undergoing chemotherapy. Studies of HIV-positive patients have suggested that smoked marijuana can improve appetite and trigger weight gain.
Donald Abrams, a doctor and professor at the University of California, San Francisco who has studied marijuana, says he recommends it to some cancer patients, including those who haven’t found standard anti-nausea drugs effective and some with loss of appetite.
Side effects can be a problem for some people. Thea Sagen, 62, an advanced neuroendocrine cancer patient in Seaside, Calif., says she expected something like a pharmacy when she went to a marijuana dispensary mentioned by her oncologist. She says she was disappointed to find that the staffers couldn’t say which of the products, with names like Pot ‘o Gold and Blockbuster, might boost her flagging appetite or soothe her anxiety. “They said, ‘it’s trial and error,’ “she says. “I was in there flying blind, looking at all this stuff.”
Ms. Sagen says she bought several items and tried one-eighth teaspoon of marijuana-infused honey. After a few hours, she was hallucinating , too dizzy and confused to dress herself for a doctor’s appointment. Then came vomiting far worse than her stomach upset before she took the drug. When she reported the side effects to her oncologist’s nurse and her primary-care physician, she got no guidance. She doesn’t take the drug now. But with advice from a nutritionist, her appetite and food intake have improved, she says.
Other marijuana users may experience the well-known reduction in ability to concentrate. At least a few users suffer troubling short-term psychiatric side effects, which can include anxiety and panic. More controversially, an analysis published in the journal Lancet in 2007 tied marijuana use to a higher rate of psychotic conditions such as schizophrenia. But the analysis noted that such a link doesn’t necessarily show marijuana is a cause of the conditions.
Long-term marijuana use can lead to physical dependence, though it is not as addictive as nicotine or alcohol, says Margaret Haney, a professor at Columbia University’s medical school. Smoked marijuana may also risk lung irritation, but a large 2006 study, published in Cancer Epidemiology, Biomarkers & Prevention, found no tie to lung cancer.