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F.D.A. Dismisses Medical Benefit From Marijuana

Old 04-21-06, 04:31 AM
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F.D.A. Dismisses Medical Benefit From Marijuana

F.D.A. Dismisses Medical Benefit From Marijuana

By GARDINER HARRIS
The New York Times

WASHINGTON, April 20 — The Food and Drug Administration said Thursday that "no sound scientific studies" supported the medical use of marijuana, contradicting a 1999 review by a panel of highly regarded scientists.

The announcement inserts the health agency into yet another fierce political fight.

Susan Bro, an agency spokeswoman, said Thursday's statement resulted from a past combined review by federal drug enforcement, regulatory and research agencies that concluded "smoked marijuana has no currently accepted or proven medical use in the United States and is not an approved medical treatment."

Ms. Bro said the agency issued the statement in response to numerous inquiries from Capitol Hill but would probably do nothing to enforce it.

"Any enforcement based on this finding would need to be by D.E.A. since this falls outside of F.D.A.'s regulatory authority," she said.

Eleven states have legalized medicinal use of marijuana, but the Drug Enforcement Administration and the director of national drug control policy, John P. Walters, have opposed those laws.

A Supreme Court decision last year allowed the federal government to arrest anyone using marijuana, even for medical purposes and even in states that have legalized its use.

Congressional opponents and supporters of medical marijuana use have each tried to enlist the F.D.A. to support their views. Representative Mark Souder, Republican of Indiana and a fierce opponent of medical marijuana initiatives, proposed legislation two years ago that would have required the food and drug agency to issue an opinion on the medicinal properties of marijuana.

Mr. Souder believes that efforts to legalize medicinal uses of marijuana are a front for efforts to legalize all uses of it, said Martin Green, a spokesman for Mr. Souder.

Tom Riley, a spokesman for Mr. Walters, hailed the food and drug agency's statement, saying it would put to rest what he called "the bizarre public discussion" that has led to some legalization of medical marijuana.

<B>The Food and Drug Administration statement directly contradicts a 1999 review by the Institute of Medicine, a part of the National Academy of Sciences, the nation's most prestigious scientific advisory agency. That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting." </B>

Dr. John Benson, co-chairman of the Institute of Medicine committee that examined the research into marijuana's effects, said in an interview that the statement on Thursday and the combined review by other agencies were wrong.

The federal government "loves to ignore our report," said Dr. Benson, a professor of internal medicine at the University of Nebraska Medical Center. "They would rather it never happened."
<b>
Some scientists and legislators said the agency's statement about marijuana demonstrated that politics had trumped science. </B>

"Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science," said Dr. Jerry Avorn, a medical professor at Harvard Medical School.

Representative Maurice D. Hinchey, a New York Democrat who has sponsored legislation to allow medicinal uses of marijuana, said the statement reflected the influence of the Drug Enforcement Administration, which he said had long pressured the F.D.A. to help in its fight against marijuana.

A spokeswoman for the Drug Enforcement Administration referred questions to Mr. Walters's office.

The Food and Drug Administration's statement said state initiatives that legalize marijuana use were "inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the F.D.A. approval process."

But scientists who study the medical use of marijuana said in interviews that the federal government had actively discouraged research. Lyle E. Craker, a professor in the division of plant and soil sciences at the University of Massachusetts, said he submitted an application to the D.E.A. in 2001 to grow a small patch of marijuana to be used for research because government-approved marijuana, grown in Mississippi, was of poor quality.

In 2004, the drug enforcement agency turned Dr. Craker down. He appealed and is awaiting a judge's ruling. "The reason there's no good evidence is that they don't want an honest trial," Dr. Craker said.

Dr. Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, said he had studied marijuana's medicinal effects for years but had been frustrated because the National Institutes of Health, the leading government medical research agency, had refused to finance such work.

With financing from the State of California, Dr. Abrams undertook what he said was a rigorous, placebo-controlled trial of marijuana smoking in H.I.V. patients who suffered from nerve pain. Smoking marijuana proved effective in ameliorating pain, Dr. Abrams said, but he said he was having trouble getting the study published.

"One wonders how anyone" could fulfill the Food and Drug Administration request for well-controlled trials to prove marijuana's benefits, he said.

Marinol, a synthetic version of a marijuana component, is approved to treat anorexia associated with AIDS and the nausea and vomiting associated with cancer drug therapy.

GW Pharmaceutical, a British company, has received F.D.A. approval to test a sprayed extract of marijuana in humans. Called Sativex, the drug is made from marijuana and is approved for sale in Canada. Opponents of efforts to legalize marijuana for medicinal uses suggest that marijuana is a so-called gateway drug that often leads users to try more dangerous drugs and to addiction.

But the Institute of Medicine report concluded there was no evidence that marijuana acted as a gateway to harder drugs. And it said there was no evidence that medical use of marijuana would increase its use among the general population.

Dr. Daniele Piomelli, a professor of pharmacology at the University of California, Irvine, said he had "never met a scientist who would say that marijuana is either dangerous or useless."

Studies clearly show that marijuana has some benefits for some patients, Dr. Piomelli said.

"We all agree on that," he said


From The New York Times

<I>
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Old 04-21-06, 05:36 AM
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Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine

Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor's recommendation, even though it is not an approved drug.

Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.

FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.

A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html
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Old 04-21-06, 05:42 AM
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This reads like a dodge to me. "Until a drug undergoes clinical studies, the FDA will not approve it for medical use. Marijauna has not gone through clinicals, so it is not approved."

That distributing marijuana as part of a scientific study will get the scientists arrested doesn't enter into it.
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Old 04-21-06, 07:01 AM
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It's 1984 and this report is doubeplusgood!
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Old 04-21-06, 10:04 AM
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Well, hell. If the F.D.A. says so, it must be correct.
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Old 04-21-06, 10:16 AM
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If something doesn't make medical industries obscenely wealthy, the FDA goes against it.
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Old 04-21-06, 10:18 AM
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Originally Posted by Palpadious
If something doesn't make medical industries obscenely wealthy, the FDA goes against it.
Interesting theory, any links or facts to go along with it?

Why do you think Pharmaceutical companies wouldn't make bank if Marijuana were legalized?
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Old 04-21-06, 10:21 AM
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Originally Posted by Bushdog
Why do you think Pharmaceutical companies wouldn't make bank if Marijuana were legalized?
They probably have already budgeted for greenhouses and lamps.
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Old 04-21-06, 10:22 AM
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Originally Posted by Bushdog
Interesting theory, any links or facts to go along with it?

Why do you think Pharmaceutical companies wouldn't make bank if Marijuana were legalized?
Perhaps the fact that anyone can grow it?
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Old 04-21-06, 10:25 AM
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Originally Posted by Pistol Pete
Perhaps the fact that anyone can grow it?
Anyone can make beer, liquor, or wine. That doesn't seem to stop the liquor industry from making a tidy profit.
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Old 04-21-06, 10:31 AM
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Originally Posted by funkyryno
WASHINGTON, April 20 —
Isn't it ironic....
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Old 04-21-06, 10:35 AM
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Originally Posted by Red Dog
Anyone can make beer, liquor, or wine. That doesn't seem to stop the liquor industry from making a tidy profit.
True, anyone can make beer, liquor, or wine, but doing so takes either a good bit of effort, care, knowledge, and skill, or a tremendous amount of luck. You can grow pot without even trying. It's called "weed" for a reason, you know - it will grow almost anywhere, with little or no effort.
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Old 04-21-06, 10:37 AM
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Originally Posted by wendersfan
True, anyone can make beer, liquor, or wine, but doing so takes either a good bit of effort, care, knowledge, and skill, or a tremendous amount of luck. You can grow pot without even trying. It's called "weed" for a reason, you know - it will grow almost anywhere, with little or no effort.

Yeah, but I'm lazy.
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Old 04-21-06, 10:38 AM
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Originally Posted by wendersfan
True, anyone can make beer, liquor, or wine, but doing so takes either a good bit of effort, care, knowledge, and skill, or a tremendous amount of luck. You can grow pot without even trying. It's called "weed" for a reason, you know - it will grow almost anywhere, with little or no effort.
But specific to medical marijuana, there are certain to be "rigors" put in for dosing, chemical content, etc....
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Old 04-21-06, 10:39 AM
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Originally Posted by Red Dog
Yeah, but I'm lazy.
Hence the irony - the more you grow, the more you smoke. The more you smoke, the lazier you get.
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Old 04-21-06, 10:42 AM
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Originally Posted by Bushdog
But specific to medical marijuana, there are certain to be "rigors" put in for dosing, chemical content, etc....
I understand, but I was responding specifically to <b>RedDog</b>'s comment that "anyone" can brew, distill, or whatever you do to make wine...
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Old 04-21-06, 10:45 AM
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Originally Posted by wendersfan
I understand, but I was responding specifically to <b>RedDog</b>'s comment that "anyone" can brew, distill, or whatever you do to make wine...

Still, if we get to a day where pot is legalized, whether across the board or for medical purposes, it will be tightly controlled, and it will likely be the pharmaceuticals or tobacco companies (everyone's 2 favorites) that will be the 'government sanctioned' producers.
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Old 04-21-06, 10:50 AM
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Originally Posted by Red Dog
Still, if we get to a day where pot is legalized, whether across the board or for medical purposes, it will be tightly controlled, and it will likely be the pharmaceuticals or tobacco companies (everyone's 2 favorites) that will be the 'government sanctioned' producers.
Yeah, and that will well and truly suck. What's even more galling (to me) is the standard, "let's legalize it and tax the shit out of it" argument, as if it's OK to legalize things we otherwise disapprove of, as long as we can generate government income from them (which just gives the government even more power).

My solution has consistently been, make it legal to grow it, possess it, and use it, but don't legalize "trafficking". I've never known anyone who could smoke more than they could grow,

(Please note: the above is for "recreational" use. Medical use would be different.)
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Old 04-21-06, 02:05 PM
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Nice to see another sound medical judgement by the F.D.A.

Originally Posted by wendersfan
True, anyone can make beer, liquor, or wine, but doing so takes either a good bit of effort, care, knowledge, and skill, or a tremendous amount of luck. You can grow pot without even trying. It's called "weed" for a reason, you know - it will grow almost anywhere, with little or no effort.
It's easy to get it to sprout, it's tough to grow well*










*or so I've been told
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Old 04-21-06, 02:18 PM
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The FDA is more of a political organization than it is a medically-sound and scientific organization.
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Old 04-21-06, 11:06 PM
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Originally Posted by Bushdog
Interesting theory, any links or facts to go along with it?
You can put flouride in the water, you can put it in OTC mouthwash, you can put it in toothpaste, but dare to sell it in pill form for children and you need a prescription.
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Old 04-22-06, 12:28 PM
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Originally Posted by wendersfan
True, anyone can make beer, liquor, or wine, but doing so takes either a good bit of effort, care, knowledge, and skill, or a tremendous amount of luck. You can grow pot without even trying. It's called "weed" for a reason, you know - it will grow almost anywhere, with little or no effort.
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Old 03-16-07, 11:24 AM
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New Mexico is expected to be the 12th state to legalize medical marijuana.
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Old 03-16-07, 11:30 AM
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The vision in my right eye is blurry. Do I qualify?
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Old 03-16-07, 03:03 PM
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This is FDR's fault.

When they outlawed alcohol, everyone knew there was no such federal power, so they had to amend the constitution.

When they outlawded marijuana later on, there was no such amendment.

That's because FDR ruined the concept of the 10th amendment and limited federal power.

The Supreme Court planned to rule FDR's New Deal unconstitutional. But then he threatened to pack the court with extra justices, and the court changed its mind.

In the 1942 case Wickard v Filburn, a farmer grew more wheat than the federal government gave him permission to grow. The wheat never crossed state lines, and no money changed hands. But the court said it was "interstate commerce" anyway.

That was one of the worst rulings ever. It destroyed the concept of the 10th amendment and limited federal power.

FDR eliminated limited government and seperation of powers, and turned the presidency into a dictatorship. That's why FDR is the worst president this country ever had.

In the 2005 case Gonzales v Raich, the court upheld the federal ban against medical marijuana.

The marijuana never crossed state lines, and no money ever changed hands. But the court voted to uphold the ban, because they didn't want to overturn Wickard v Filburn.

Their love of federal power exceeds any concern they allegedly have for individual liberty, civil rights, sick people, the Constitution, or the Bill of Rights.

This is a lot like Kelo v New London. Because the court doesn't care at all about the little guy.

Here's an update:


http://www.washingtonpost.com/wp-dyn...401364_pf.html

Medical Marijuana Use Dealt Setback

Associated Press

Thursday, March 15, 2007; A11

SAN FRANCISCO, March 14 -- A woman whose doctor says marijuana is the only medicine keeping her alive can face federal prosecution on drug charges, a federal appeals court ruled Wednesday.

The ruling was the latest legal defeat for Angel Raich, a mother of two from Oakland suffering from scoliosis, a brain tumor, chronic nausea and other ailments who sued the government preemptively to avoid being arrested for using the drug. On her doctor's advice, Raich eats or smokes marijuana every two hours to ease her pain.

The Supreme Court ruled against Raich in June 2005, saying medical marijuana users and their suppliers could be prosecuted for breaching federal drug laws even if they lived in a state such as California, where medical use of the drug is legal.

When told of the decision, Raich, 41, began sobbing. "I'm sure not going to let them kill me," she said.

Last edited by grundle; 03-16-07 at 03:05 PM.
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