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Posted on 04/21/2006 8:43:49 AM PDT by 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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ping
Do you guys write press releases for the FDA now? :-)
Safe for taxation because it's not common to grow your own tobacco for personal use.
Libertarian ping! To be added or removed from my ping list freepmail me or post a message here.
I'm not sure if non aol users can take the survey or not but the link is here
The War on Cancer Patients
Hell no, we won't go...
4/20 was yesterday, dood...
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?"
''...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.
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.
As prescribed medicine? Of course it should. And it is.
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...
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."
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.
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."
Of course, if they have a problem it's a specific for. Though, brownies may be the best delivery method. 
Gee, I guess they couldn't care less about children. Only the adults get the good medicine, huh?
Alcohol and tobacco have been part of the American culture for centuries. For hundreds of years, alcohol and tobacco have been used in ceremonies (both civil and religious), as part of meals, as gifts, in social settings, as barter, and as a rite-of-passage.
Marijuana was introduced to the U.S. in the 20th century and is more a part of the sub-culture.
Why do you think marijuana is even close to comparable to alcohol and tobacco?
Geez, you're trying to turn the FDA into Consumer Reports. Not all products are regulated by the FDA. Not all need to be regulated. Alcohol and tobacco are not.
An act of Congress would change that, as it did with the other drugs. Write your Congressman.
And in the very next sentence:
"Nonetheless, for certain patients, such as the terminally ill or those with debilitating symptoms, the long-term risks are not of great concern. Further, despite the legal, social, and health problems associated with smoking marijuana, it is widely used by certain patient groups."
Kinda like, hey, they're gonna die anyways. Right?
Is this the group currently being addressed by state medical marijuana laws? The terminally ill or those with debilitating symptoms? Would you support restricting medical marijuana to those who are dying?
I support whatever laws the People of a State vote in.
BTW, have you addicts heard what the pro-illegal immigration people are saying about the border fence, and other attempts to protect our sovereignty? "It'll never work 'cause people who want to come into this country will always find a way". Does that argument sound familiar to you?
All well and good -- but let's not pretend that the IOM does also.
It is odd to hear Bush embracing legalization on one issue, while rejecting it on another.
I always knew sucking down carbon monoxide was good for me.
Gee, I guess they couldn't care less about children. Only the adults get the good medicine, huh?
Ever heard of paregoric?
(Extinct, robert, look it up)
The courts should make law, the administrative agencies should make law. It's only unconstitutional for Congress to make law, doncha know?
It's all about the money.
I'm not an addict, but I'll address your post anyway ... to note that the argument applies much more strongly to illegal actions don't violate anyone's rights (such as selling or using drugs), because in those cases there are no victims to avoid, resist, or cooperate in the prosecution of the act. (Illegal entry, by contrast, is a form of trespass, an act that does have victims.)
Kinda like, hey, they're gonna die anyways. Right?
Why should someone who has a year to live care about the possible 20-year effects of a medication? I wouldn't ... would you?
Gee, you think they'd mind if we took a kidney? Half their liver? A cornea? I mean, why should someone who has a year to live care about their __________?
Can we run some medical experiments on them? Test some drugs? I mean, why should someone who has a year to live care about some medical testing and experimental drugs?
It's called human dignity, MrLeRoy. Something you wouldn't understand in your utilitarian, libertarian utopia.
Gee, you think they'd mind if we took a kidney? Half their liver? A cornea? I mean, why should someone who has a year to live care about their __________?
Can we run some medical experiments on them? Test some drugs? I mean, why should someone who has a year to live care about some medical testing and experimental drugs?
With their informed consent, certainly.
It's called human dignity
Forcing other adults to act as YOU think best is the antithesis of "human dignity."
No, passing legislation to prevent you and your ilk from treating people as mere commodities to be sliced and diced and sold off to the highest bidder is my definition of maintaining human dignity.
Like I said, you want to force other adults to act as YOU think best regardless of their informed consent. Your definition of "maintaining human dignity" is beneath contempt.
No reasonable person agrees with such nonsense. I don't who you're criticizing here.
Having smoked pot regularly for over 20 years, I tend to agree with this.
However, if it can help anybody fight the side-effects of chemo or has other uses that aleviate suffering, I am all for allowing medical use.
You replied,
Gee, you think they'd mind if we took a kidney? Half their liver? A cornea? I mean, why should someone who has a year to live care about their __________?
and,
Can we run some medical experiments on them? Test some drugs? I mean, why should someone who has a year to live care about some medical testing and experimental drugs?
The medication is supposed to take away the pain they're already in. Harvesting organs and running medical experiments cause pain, and worse, the psychological pain of positive knowledge you're being damaged.
Robert, why would anyone work so hard at the keyboard to deny relief to people in pain? What's your fear? Maybe they'll recover and be addicted? Why not just allow that to be and no be so worried about it?
PMS. They need to do a study about marijuana and its effect on PMS.
No, the question was about legalizing the use of smoked marijuana for medical use, a non-FDA approved medicine with unknown side effects and unknown drug interactions, to treat symptoms treatable by dozens of existing FDA approved medicines. And the reason given was that "they're going to die anyways". Well, with that kind of an attitude, why not the other things I mentioned?
Why would someone suggest such legalization? Why, as a red herring to open the door to full legalization for recreational use. Despicable that people would use the sick and dying as pawns in their selfish and hedonistic quest.
Chemotherapy suppresses the immune system, making the patient susceptible to fungal or bacterial infection. Marijuana may contain both.
"Hamadeh and associates. Chest, Vol. 94/2, pp.432-433, 1988. "Invasive aspergillosis has become a significant cause of death in immunosuppressed patients". Physicians should be aware of this potentially lethal complication of marijuana use in compromised hosts such as patients with AIDS or malignancies.)"
"Transplantation, Vol. 61, June 27, 1996. (Marijuana smoke transmits aspergillosis, a fungus having up to a 90% fatality rate if contracted by transplant patients. Researchers have strongly warned against the use of marijuana in immuno-compromised patients such as those with AIDS, chronic granulomatous disease, bone marrow transplants and those receiving chemotherapy for small cell lung cancer.)"
"Voth EA, Schwartz RH. Medicinal applications of delta 9 THC and marijuana: a perspective. Annals of Internal Medicine 1997: 126:791-8. (Marijuana is not a panacea. It is an impure weed that introduces immuno compromised patients to bacteria, fungi, and other toxic complications. We recommend sticking with predictable medical therapies and not deviating from FDA approved medicine in exchange for herbal remedies."
Cannabis sativa and indica has been in the English and American medical lexicons and pharmaceutics for centuries, until the recent craze.
And the reason given was that "they're going to die anyways". Well, with that kind of an attitude, why not the other things I mentioned?
Because, let me say again, taking the drug relieves pain, whereas the other things you mentioned cause pain.
(extinct, robert, look it up)
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