Posts Tagged ‘FDA’

Medical Marijuana: Pot of Gold or Pipe Dream?

Wednesday, May 5th, 2010

May 4, 2010 – In about a dozen states, you can smoke a joint if you have cancer or HIV and meet certain conditions, like having a doctor’s note.

In California, you can light up if you have just about anything — headaches, anxiety, epilepsy — and a physician’s OK.

Illinois could join these states as legislators consider a bill that would allow patients to use marijuana as medicine as long as they have one of 14 conditions and illnesses, including cancer and Crohn’s disease.

But interviews with scientists and physicians and a review of medical literature reveal scant evidence that marijuana is a safe and effective treatment for most of those 14.

A handful of uses in the bill — such as pain suffered by people with HIV and cancer — are supported by some solid scientific evidence. But none meet the standards, such as multiple large, well-designed clinical trials, required by the U.S. Food and Drug Administration in approving new drugs.

“What defines a medicine? And how do we bring medicines to market?” said Dr. Eric A. Voth, chairman of the Institute on Global Drug Policy. “And we do not bring them through the legislative vote process and say: ‘Here, we deem this as medicine.’”

And yet the momentum across the U.S. leans toward legalizing medical marijuana, with bills being weighed from Pennsylvania to Ohio. On Tuesday, the District of Columbia Council passed a measure that legalizes medical cannabis. Advocates also are championing a change in federal law.

In the world of medicine, there’s nothing quite like pot. It’s a medicine sold with names like Haze ($160 an ounce at one California dispensary) and Grand Daddy Purple ($300 an ounce), and descriptions like “get lifted and be happy”; a stigmatized plant with therapeutic promise that few want to study because it remains illegal on the federal level and a drug that raises concerns because it often is smoked.

“We need more science and we need to treat it like a medicine,” said Allan Young, a professor of psychiatry at the University of British Columbia who is conducting a trial examining the effect of chemicals in marijuana on bipolar disorder.

Advocates say they are only trying to decriminalize use of the plant by sick people who have failed to gain relief from pharmaceutical drugs. Under the Illinois bill, patients with permission from the state and a physician would be able to possess 2 ounces of dried marijuana or grow a small number of plants.

“These sick people are looking for compassion,” said Dan Linn, executive director of the Illinois Cannabis Patients Association. “And if treatment includes cannabis, in Illinois, should we consider these people criminals?”

Illinois Rep. Lou Lang, a sponsor of the Illinois bill, said: “We have to think of this as a product, not a drug. Not as a menace. Nobody has ever died from an overdose of marijuana.”

But there is reason to worry that marijuana could actually prove harmful for patients with some of the conditions it is supposed to treat.

Take glaucoma, a disease listed in the Illinois bill and often cited by advocates because marijuana can lower the pressure inside the eye. Increased eye pressure is a common feature of glaucoma, and can lead to damage of the optic nerve and blindness.

“They think that even if this unconventional therapy doesn’t work that it can’t possibly hurt their disease,” said Dr. James Tsai, chairman of the Department of Ophthalmology and Visual Science at Yale University School of Medicine and chairman of the medical advisory board at The Glaucoma Foundation. “However, studies suggest that it might be, in fact, damaging to do so.”

Marijuana only lowers pressure for several hours, requiring patients to continuously medicate day and night, glaucoma experts said. Failing to do so can lead to a rebound spike in eye pressure, which can be damaging. Marijuana also can lower blood pressure, which can damage the optic nerve.

In February, the Journal of Glaucoma ran an editorial warning against using pot to treat glaucoma.

Epilepsy is another disease commonly cited by advocates as treatable because marijuana is suspected to have anti-seizure properties. But ask epilepsy experts and they will tell another story.

“Statistically, there is no evidence that it is effective when used as a therapeutic agent and, besides, it has more side effects than other anti-seizure medications available,” said neurologist Dr. Stephan Schuele, medical director of the Northwestern University Comprehensive Epilepsy Center.

There are serious concerns, said neurologist Dr. Alan Ettinger, epilepsy director of Neurological Surgery in Rockville Center, N.Y., and a member of the executive board of the national Epilepsy Foundation. First, he said, withdrawal among chronic users with epilepsy can cause severe exacerbations of the seizures.

And, he said, some individuals with epilepsy are struggling with depression, sleepiness and cognitive difficulties to begin with. Marijuana can compound these problems, he said.

Like glaucoma and epilepsy, research is mixed when it comes to another commonly cited medical use of marijuana — spasticity in people with multiple sclerosis, according to experts in the field.

One trial in Europe found that objective measures showed cannabis did not affect spasticity, even though patients thought it did, said neurologist Dr. Carlo Pozzilli, director of the Multiple Sclerosis Center in Rome, who has conducted research on cannabis and multiple sclerosis. It did, however, affect pain.

“This is the gap between what the patients say and what the doctor sees in terms of objectivity,” Pozzilli said. “This is the big problem of cannabis as a therapeutic.”

Advocates say marijuana can be a safe and effective alternative to FDA-approved pharmaceuticals, which can come with their own addiction problems and side effects. Mike Graham, a 47-year-old former restaurant manager from Manteno, Ill., said his degenerative disc disease left him bedridden with horrible nerve pain. “It is like getting hit by a baseball bat every time my heart beats,” he said. “Boom. Boom. Boom. It doesn’t stop.”

The painkillers he was taking, including a morphine pump, failed to manage the pain but caused nausea and vomiting, he said. A hospice nurse suggested he try pot. He said it worked. Now he takes several puffs every three hours. “There is no euphoric feeling, but I can have a semblance of a life,” said Graham, co-director of the Illinois chapter of Americans for Safe Access.

His story echoes that of the Rev. Wayne Dagit, a Michigan minister who runs a cannabis smokers club in Williamston, Mich., and is pushing for the Illinois bill.

Dagit said he awakens some mornings in so much pain that he can barely move. He has been prescribed oxycodone, a strong painkiller that can become addictive and takes 30 minutes to take effect. “But,” he said, “if I can scoot up to the edge of the bed and do one hit (of marijuana), I wait four minutes and it is a euphoric effect and that is all I need.”

Researchers long have been intrigued by marijuana’s possibilities. Could cannabinoids, which affect areas of the brain that control movement, help people with multiple sclerosis control spasticity? Could the chemicals, which affect areas of the brain associated with stress, help veterans suffering from post-traumatic stress disorder?

In 1999, the Institute of Medicine released a report citing the promise of cannabinoids, recommending short-term use of marijuana for debilitating conditions like intractable pain or vomiting if, among other conditions, all other treatments have failed.

The report mostly calls for more research on uses of cannabis. But since that report, relatively little work has been done. Marijuana’s status as an illegal drug, not just in the United States but across much of the world, has stymied researchers.

Marijuana, especially smoked marijuana, as a target of research faces serious obstacles, said internist Dr. Eric Larson, a co-author of the 1999 Institute of Medicine report. “It is an orphan drug, there is no U.S. company that is going to promote it and then there’s the stigma,” he said.

Larson said the social advocacy groups — pro and con — also make marijuana an unpopular choice for researchers. “Many traditional scientists will say, ‘I don’t want to have to deal with this sort of wild advocacy group where my science runs the risk of being expropriated for an agenda that isn’t about discovery but rather about advocating a point of view.’” Source.

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Denver Debate: Does Marijuana Have Healing Properties?

Monday, April 12th, 2010

April 12, 2010 – The University of Denver kicked off a series of debates on marijuana last Thursday with a discussion of the potential medical benefits and harms of the drug.

Alice P. Mead, a spokeswoman for a British research company that develops a medical spray from marijuana, argued that the Food and Drug Administration ( FDA ) should regulate marijuana if doctors are recommending it to patients. She said the FDA process has been carefully crafted for more than 100 years, and while not foolproof, gives medical professionals the information on the purity, potency and identity of a product.

“I’m pro the proper testing and standardization of medical products before they’re widely distributed to seriously ill patients,” she said.

In yesterday’s discussion, Mead squared off against Sunil Aggarwal, a fourth-year medical student at the University of Washington. Aggarwal argued that the medical community has extensive knowledge about the 400-plus chemicals in marijuana. More than 17,500 research papers and articles on marijuana or its properties came out in 2008 alone, he said.

He added that because marijuana is federally classified as a schedule I drug meaning it has a high potential for abuse and no legitimate medical use it’s unlikely that the FDA would regulate the drug.

But Mead said there is a precedent for the FDA approving a formulated product derived from a scheduled I drug; Marinol, which is primarily comprised of THC and helps stimulate HIV/AIDS patients’ appetites, is a scheduled III drug even though it has the major psychoactive ingredient in marijuana.

Healing properties

Aggarwal is convinced of the healing properties of marijuana. There is no evidence linking smoked marijuana to cancer, and a published study in peer-review literature found that cannabinoids the active ingredients in marijuana reduced the size of brain tumors, he said.

Mead believes there are certain non-psychoactive cannabinoids in marijuana that have healing properties, though most of them have been phased out as marijuana has become a recreational drug. Sativex, the drug her company GW Pharmaceuticals makes is a cannabis extract containing THC and Cannabidiol, a part of marijuana that allegedly carries medicinal benefits without the possible psychoactive properties of THC. The clinical spray is approved in Canada to treat pain and multiple sclerosis.

Because the THC content varies wildly for each marijuana plant and there are multiple ways to ingest the drug, Mead believes the cannabinoids would need to be extracted from the marijuana in order to be regulated by the FDA. But she sees tremendous potential benefits if the FDA regulated marijuana.

For one, the FDA process would garner the data necessary for marijuana products to become broadly accepted as true modern medications. Additionally, the current system in place in states like Colorado and California in which patients are ingesting non-FDA-approved marijuana is possibly leading to sick patients ingesting a high amount of undetected pesticides, fungi and bacteria. Marijuana samples taken from select California dispensaries found the drug had a level of pesticides that was 170 times higher than herbal products, she said.

Without the FDA process, untrained dispensary owners who are not required to have a background in medicine end up making a variety of claims for their products that may or may not be true, Mead said. Mead’s experiences in California have led her to believe that many of the doctors recommending medical marijuana to patients do not always have the patient’s health in mind.

But Aggarwal argued that doctors have historically recommended drugs on a see-if-it-works basis. And with many seriously ill patients reporting a positive reaction to medicinal marijuana, he sees validity in having doctors recommend the drug to patients.

Aggarwal agreed with Mead that more research is needed on marijuana, saying the last time a major scientist got access to marijuana was in the early 1940s. The resulting report from the New York Academy of Medicine contradicted claims that marijuana results in insanity, assists in criminal behavior, is physically addictive and is a “gateway drug” to harder drugs. The report was blasted and discredited by anti-marijuana lawmakers.

Mead said the DEA has become increasingly receptive towards allowing legitimate researchers to study marijuana in recent years. She added that there is research currently being done in Europe on marijuana that could prove beneficial.

“Doing evidence-based research takes time,” she said. “It is happening, it’s just that it’s not happening as quickly as we’d all like.” Source.

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