Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine

http://www.fda.gov/ ^ | 4 20 06 | fda

[freepatriot32]

FDA Statement

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.

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[freepatriot32]

The History of the Marihuana Tax Act of 1937

[freepatriot32]

ping

[P-40]

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.

So....are cigarettes safe?

[freepatriot32]

Do you guys write press releases for the FDA now? :-)

[Sir Gawain]

Safe for taxation because it's not common to grow your own tobacco for personal use.

[traviskicks]

Libertarian ping! To be added or removed from my ping list freepmail me or post a message here.

[freepatriot32]

There is a survey going on at aol asking if you think medical marijuana should be legal and so far out of 54,000 votes its running 90 percent yes 10 percent no and another question is was the fda report motivated by politics or sciences or both that is at politics 76 percent both 18 percent and science 6 percent

I'm not sure if non aol users can take the survey or not but the link is here

Should marijuana be legal for medical uses?

[robertpaulsen]

The U.S. Supreme Court ruled in FDA v. Brown & Williamson that the FDA does not have the legal authority to regulate tobacco (though they do have the authority to regulate nicotine). The majority opinion concluded that if Congress intended for the FDA to regulate tobacco, it should say so.

[Lexington Green]

The War on Cancer Patients

Hell no, we won't go...

[Trampled by Lambs]

4/20 was yesterday, dood...

[P-40]

the FDA does not have the legal authority to regulate tobacco

I have always found that hilarious. A product meant for public consumption that, if used property, will kill you or impair your health...but it is legal.

[robertpaulsen]

A great follow up question would be, "Should medicine only be available to those over 21? If you answer no, then should medical marijuana be available to 11-year-olds?"

[Lexington Green]

''...should MORPHINE be available to 11-year-olds?"

Hell no. They must be good little Drug Nazis and accept their suffering. It's the American way.

[robertpaulsen]

"A product meant for public consumption that, if used property, will kill you or impair your health...but it is legal."

If you feel that strongly about it, write your Congressman. Seriously. The court didn't say that the FDA couldn't regulate tobacco -- they said they couldn't without Congressional approval.

I assume from your post that you approve of the Congressional laws against recreational drugs.

[robertpaulsen]

"''...should MORPHINE be available to 11-year-olds?"

As prescribed medicine? Of course it should. And it is.

[traviskicks]

yea, you can vote if you're not an aol member. Good to see at least 55,000 or so people are freedom loving.

I bet most of them are younger (as internet users are), and probably non voters. So their opinion doesn't count.

Us under 30 people really need to start voting on stuff like this and pesonal retirment accounts etc...

[P-40]

I assume from your post that you approve of the Congressional laws against recreational drugs.

It would be a lost cause to ask Congree to do anything with regards to tobacco. There is simply too much money involved with that drug.

I don't approve of laws against some recreational drugs as the crime does not fit the punishment in too many cases and the risk of using the drug is just not serious enough to bother when compared to a drug like alcohol. We have some serious problems with alcohol in this country but too much of the money goes to dealing with the other drugs.

[Wolfie]

The FDA 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 evaluative agency. That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting."

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 FDA statement and the combined review by other agencies were wrong.

The federal government "loves to ignore our report," said Benson, a professor of internal medicine at the University of Nebraska Medical Center. "They would rather it never happened."

[robertpaulsen]

OK. On this medical marijuana thread, you no longer want to talk about tobacco. Fine.

Now you bring up alcohol as the new gold standard (ie., if a drug is less risky than alcohol, why isn't it legal and if it's riskier then it's OK by you if we make it illegal -- do I have that right?).

What this has to do with medical marijuana, I don't know. When you want to get back to the topic at hand, feel free.

[robertpaulsen]

"That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting."

Out of respect, I'll keep my response civil.

I believe the report stated that "cannabinoids would be moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting", not marijuana.

And three paragraphs down, in the "Conclusion" section, it states that "smoked marijuana, however, is a crude THC delivery system that also delivers harmful substances and that (later in the same report) smoked marijuana should generally not be recommended for medical use."