FDA rejects marijuana

Deacon · Apr 21, 2006

FDA Rejects Marijuana For Medical Uses [LINK]

"...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."

Rob

Kilad · Apr 21, 2006

Good for them, wonderful news.

Daisy · Apr 21, 2006

I wonder how much of this decision was driven by medical science and how much by politics.

Bro. Curtis · Apr 21, 2006

Yup. They are correct on the dangers of recreational use, but just like the opium poppy, the medical benefits have been proven.

Why would God put marijuana on the Earth, and not have a purpose ? It seems to me, after the garden, everything was OK to use for the benefit of humanity.

Deacon · Apr 21, 2006

When employed for the purpose of healing, promoting wellness or for lessening of symptoms marijuana is a poor substitute for a multitude of other agents that perform more effectively and safely.

Originally posted by Bro. Curtis:
Why would God put marijuana on the Earth, and not have a purpose? It seems to me, after the garden, everything was OK to use for the benefit of humanity.

As the teacher in Ecclesiastes states, "To everything there is a season..."
The FDA is merely saying that "the season" for the medical use of marijuana has passed.

Rob

Bro. Curtis · Apr 21, 2006

Well, I disagree, Deacon. I say we haven't unlocked it, as of yet.

Deacon · Apr 21, 2006

Cool man I'm hip

billwald · Apr 21, 2006

To many politicians getting rich off the system the way it is.

The Galatian · Apr 21, 2006

The drug lords don't want the "war on drugs" to end. It keeps prices up. If marijuana was legalized, the price would drop like a rock.

Daisy · Apr 21, 2006

Here (linkie) is the FDA news release.

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.

<snip>

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.
Click to expand...

And here (linkie) is the 1999 Institute Of Medicine's report (from the National Academy of Science). The IOM report is comprehensive - worth reading if you want to understand the medical view, so here's the recommendations from the Executive Summary:

<snip>

RECOMMENDATIONS
Recommendation 1: Research should continue into the physiological effects of synthetic and plant-derived cannabinoids and the natural function of cannabinoids found in the body. Because different cannabinoids appear to have different effects, cannabinoid research should include, but not be restricted to, effects attributable to THC alone.

Scientific data indicate the potential therapeutic value of cannabinoid drugs for pain relief, control of nausea and vomiting, and appetite stimulation. This value would be enhanced by a rapid onset of drug effect.

Recommendation 2: Clinical trials of cannabinoid drugs for symptom management should be conducted with the goal of developing rapid-onset, reliable, and safe delivery systems.

The psychological effects of cannabinoids are probably important determinants of their potential therapeutic value. They can influence symptoms indirectly which could create false impressions of the drug effect or be beneficial as a form of adjunctive therapy.

Recommendation 3: Psychological effects of cannabinoids such as anxiety reduction and sedation, which can influence medical benefits, should be evaluated in clinical trials.

Numerous studies suggest that marijuana smoke is an important risk factor in the development of respiratory diseases, but the data that could conclusively establish or refute this suspected link have not been collected.

Recommendation 4: Studies to define the individual health risks of smoking marijuana should be conducted, particularly among populations in which marijuana use is prevalent.

Because marijuana is a crude THC delivery system that also delivers harmful substances, smoked marijuana should generally not be recommended for medical use. Nonetheless, marijuana is widely used by certain patient groups, which raises both safety and efficacy issues.

Recommendation 5: Clinical trials of marijuana use for medical purposes should be conducted under the following limited circumstances: trials should involve only short-term marijuana use (less than six months), should be conducted in patients with conditions for which there is reasonable expectation of efficacy, should be approved by institutional review boards, and should collect data about efficacy.

If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives. Isolated cannabinoids will provide more reliable effects than crude plant mixtures. Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as a first step toward the development of nonsmoked rapid-onset cannabinoid delivery systems.

Recommendation 6: Short-term use of smoked marijuana (less than six months) for patients with debilitating symptoms (such as intractable pain or vomiting) must meet the following conditions:


failure of all approved medications to provide relief has been documented,

the symptoms can reasonably be expected to be relieved by rapid-onset cannabinoid drugs,

such treatment is administered under medical supervision in a manner that allows for assessment of treatment effectiveness, and

involves an oversight strategy comparable to an institutional review board process that could provide guidance within 24 hours of a submission by a physician to provide marijuana to a patient for a specified use.

Click to expand...

And thanks to NPR.org for providing those links.

Bro. Curtis · Apr 24, 2006

I find "cannabinoid" to be a funny word. Like if we landed on a planet that had monsters that resembled pot leafs.

Thanx for the links.

Magnetic Poles · Apr 24, 2006

The FDA has a poor track record...approving drugs like Vioxx and Phen-Fen, yet rejecting another that has no known lethal dose, and has helped many people. The problem with marinol, as I understand it, is that it is not easy to titrate the dose. With smoked marijuana, titration is fairly easy and simple. Just because something can be misused is no reason to deny its benefits to those whom it may help.

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