(FDA-new) Marijuana has NO medical value

[rodeodance]

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html
FOR IMMEDIATE RELEASE
Statement
April 20, 2006

Media Inquiries:
FDA Press Office, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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.

[Prisoner_Number_Six]

1. That old control thang popping up again

Everybody knows that if you want a good opiate you simply watch Faux Nooz 24 hours a day.

Simple.

[Anus Retainus]

2. And which one of those three reasons...

does tobacco not pass the smoke test?

1) It has a high potential for abuse: isn't 2-3 packs a day abuse? I know quite a few heavy smokers that easily do that.

2) I've never seen a doctor prescribe "20 Camel Lights"!

3) It's unsafe to smoke in front of a doctor! (strange requirement)

It seems that once you're on that Schedule 1" list, it's hard to get off (regardless of how unreasonably it got onto the list).

[PublicWrath]

3. FDA, the same people trying to avoid approving emergency birth control

for availability over the counter because of pressure from conservative groups. Less credibility everyday.

[Asgaya Dihi]

4. No surprise

The idea that there's no accepted use is garbage, and that there's no medical support. NORML has a list of medical and patient groups that support either immediate (most of them) or research access.

http://norml.org/index.cfm?Group_ID=3390

The feds block research and pressure the top levels of some organizations but ignore the groundswell of support from the rest, and in other nations. The support is there, they just don't want to talk about it.

[K-W]

5. Marijuana doesnt meet a single schedule 1 criterion.

What a bunch of slime balls. As if marijuana has ever been given a chance to have FDA trials.

[jody]

6. Why has FDA approved Marinol for medical use? See DEA's discussion

at "Medical" Marijuana - The Facts

[Union Thug]

7. Rubbish.

Propaganda, propaganda, propaganda. I have a friend with Crohn's disease. The only thing that helps her is Marijuana.

The drug laws in this country are the most backward, anachronistic and hypocritical in the world. Unreal.

[Popol Vuh]

8. Federal Policy is Contradictory

Federal policy on medical cannabis is filled with contradictions. Cannabis is a Schedule I drug, classified as having no medicinal value and a high potential for abuse, yet its most psychoactive component, THC, is legally available as Marinol and is classified as Schedule III.

The U.S. federal government grows and provides cannabis for a small number of patients today. In 1976 the federal government created the Investigational New Drug (IND) compassionate access research program to allow patients to receive medical cannabis from the government. The application process was extremely complicated, and few physicians became involved.

In the first twelve years the government accepted about a half dozen patients. The federal government approved the distribution of up to nine pounds of cannabis a year to these patients, all of whom report being substantially helped by it.

In 1989 the "FDA" was deluged with new applications from people with AIDS, and 34 patients were approved within a year. In June 1991, the Public Health Services announced that the program would be suspended because it undercut the administration's opposition to the use of illegal drugs. The program was discontinued in March 1992 and the remaining patients had to sue the federal government on the basis of "medical necessity" to retain access to their medicine. Today, eight surviving patients still receive medical cannabis from the federal government, grown under a doctor's supervision at the University of Mississippi and paid for by federal tax dollars.

--- Americans for Safe Access

[Turtlebah]

9. The U.S are the biggest liars

on the planet. Everyone knows that.

[Turtlebah]

10. I meant to say

the U.S Government.. sorry about that.

[afrosia]

11. Done and Dusted

Well that's that then, better throw out all of my smoking paraphernalia this evening. Thank you US Government for once again demonstrating that you know best.

[HuffleClaw]

12. "concluded that no sound scientific studies supported..."

which, of course, is TRUE. what is left out is that they refuse to DO any studies because they know their mythos of harm would fall apart if they did any meaningful study, and ignore any foreign sources of information. basically, its the equivalent of a kid plugging their ears and saying 'nyah nyah nyah, i can't hear you!'

[Name removed]

13. Deleted message

Message removed by moderator. Click here to review the message board rules.

[Union Thug]

14. Rubbish. I have friends who have been prescribed medical MJ -

whose symptoms are relieved by nothing but MJ (for example, a close friend of mine has Crohn's and smoked MJ works best. Marinol wears off too quickly and is not potent).

This FDA release is just more bullshit from the half-wit generals directing the drug wars. Fuck them all.