The FDA Releases A Statement Saying Marijuana Has No Medicinal Value Whatsoever

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

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html

(Gold9472: I can't wait to see Uber Commandante's reaction to this.)

4/21/2006

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.

Is this the same FDA who was going to ban gay sperm?

You know, cause gay sperm doesn't create regular babies. Just gay ones.

Zanax

Alprazolam is a short-acting benzodiazepine used to treat anxiety disorders. It is generally sold in generic form (i.e., alprazolam) in the United States (to cut down on costs for insurance companies) and also under several brand names, depending on the country:

Xanax® - United States, Australia, United Kingdom


Alprazolam has a calming effect, with the most common side effects being drowsiness, clumsiness, and to a lesser extent, fatigue, and headache. It can also have more adverse effects, such as blurred vision, slurred speech or dysarthria, and changes in personality. It may be habit forming and users often develop a tolerance to its initial effects, although its anxiolytic efficacy remains intact. Physical and/or psychological dependence may develop after several weeks of alprazolam treatment. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for abuse and dependence. Withdrawal after long-term use should be done slowly over a period of weeks to avoid serious withdrawal symptoms such as agitation, rebound anxiety, muscle cramps and possible seizures.

Pot Shrinks Tumors; Government Knew in '74
In 1974 researchers learned that THC, the active chemical in marijuana, shrank or destroyed brain tumors in test mice. But the DEA quickly shut down the study and destroyed its results, which were never replicated -- until now.

http://www.alternet.org/story/9257/

By Raymond Cushing, AlterNet. Posted May 31, 2000.

The term medical marijuana took on dramatic new meaning in February, 2000 when researchers in Madrid announced they had destroyed incurable brain tumors in rats by injecting them with THC, the active ingredient in cannabis.

The Madrid study marks only the second time that THC has been administered to tumor-bearing animals; the first was a Virginia investigation 26 years ago. In both studies, the THC shrank or destroyed tumors in a majority of the test subjects.

Most Americans don't know anything about the Madrid discovery. Virtually no major U.S. newspapers carried the story, which ran only once on the AP and UPI news wires, on Feb. 29, 2000.

The ominous part is that this isn't the first time scientists have discovered that THC shrinks tumors. In 1974 researchers at the Medical College of Virginia, who had been funded by the National Institute of Health to find evidence that marijuana damages the immune system, found instead that THC slowed the growth of three kinds of cancer in mice -- lung and breast cancer, and a virus-induced leukemia.

The DEA quickly shut down the Virginia study and all further cannabis/tumor research, according to Jack Herer, who reports on the events in his book, "The Emperor Wears No Clothes." In 1976 President Gerald Ford put an end to all public cannabis research and granted exclusive research rights to major pharmaceutical companies, who set out -- unsuccessfully -- to develop synthetic forms of THC that would deliver all the medical benefits without the "high."

The Madrid researchers reported in the March issue of "Nature Medicine" that they injected the brains of 45 rats with cancer cells, producing tumors whose presence they confirmed through magnetic resonance imaging (MRI). On the 12th day they injected 15 of the rats with THC and 15 with Win-55,212-2 a synthetic compound similar to THC. "All the rats left untreated uniformly died 12-18 days after glioma (brain cancer) cell inoculation ... Cannabinoid (THC)-treated rats survived significantly longer than control rats. THC administration was ineffective in three rats, which died by days 16-18. Nine of the THC-treated rats surpassed the time of death of untreated rats, and survived up to 19-35 days. Moreover, the tumor was completely eradicated in three of the treated rats." The rats treated with Win-55,212-2 showed similar results.

The Spanish researchers, led by Dr. Manuel Guzman of Complutense University, also irrigated healthy rats' brains with large doses of THC for seven days, to test for harmful biochemical or neurological effects. They found none.

"Careful MRI analysis of all those tumor-free rats showed no sign of damage related to necrosis, edema, infection or trauma ... We also examined other potential side effects of cannabinoid administration. In both tumor-free and tumor-bearing rats, cannabinoid administration induced no substantial change in behavioral parameters such as motor coordination or physical activity. Food and water intake as well as body weight gain were unaffected during and after cannabinoid delivery. Likewise, the general hematological profiles of cannabinoid-treated rats were normal. Thus, neither biochemical parameters nor markers of tissue damage changed substantially during the 7-day delivery period or for at least 2 months after cannabinoid treatment ended."

Guzman's investigation is the only time since the 1974 Virginia study that THC has been administered to live tumor-bearing animals. (The Spanish researchers cite a 1998 study in which cannabinoids inhibited breast cancer cell proliferation, but that was a "petri dish" experiment that didn't involve live subjects.)

In an email interview for this story, the Madrid researcher said he had heard of the Virginia study, but had never been able to locate literature on it. Hence, the Nature Medicine article characterizes the new study as the first on tumor-laden animals and doesn't cite the 1974 Virginia investigation.

"I am aware of the existence of that research. In fact I have attempted many times to obtain the journal article on the original investigation by these people, but it has proven impossible." Guzman said.

In 1983 the Reagan/Bush Administration tried to persuade American universities and researchers to destroy all 1966-76 cannabis research work, including compendiums in libraries, reports Jack Herer, who states, "We know that large amounts of information have since disappeared."

Guzman provided the title of the work -- "Antineoplastic activity of cannabinoids," an article in a 1975 Journal of the National Cancer Institute -- and this writer obtained a copy at the University of California medical school library in Davis and faxed it to Madrid.

The summary of the Virginia study begins, "Lewis lung adenocarcinoma growth was retarded by the oral administration of tetrahydrocannabinol (THC) and cannabinol (CBN)" -- two types of cannabinoids, a family of active components in marijuana. "Mice treated for 20 consecutive days with THC and CBN had reduced primary tumor size."

The 1975 journal article doesn't mention breast cancer tumors, which featured in the only newspaper story ever to appear about the 1974 study -- in the Local section of the Washington Post on August 18, 1974. Under the headline, "Cancer Curb Is Studied," it read in part:

"The active chemical agent in marijuana curbs the growth of three kinds of cancer in mice and may also suppress the immunity reaction that causes rejection of organ transplants, a Medical College of Virginia team has discovered." The researchers "found that THC slowed the growth of lung cancers, breast cancers and a virus-induced leukemia in laboratory mice, and prolonged their lives by as much as 36 percent."

Guzman, writing from Madrid, was eloquent in his response after this writer faxed him the clipping from the Washington Post of a quarter century ago. In translation, he wrote:

"It is extremely interesting to me, the hope that the project seemed to awaken at that moment, and the sad evolution of events during the years following the discovery, until now we once again Œdraw back the veil‚ over the anti-tumoral power of THC, twenty-five years later. Unfortunately, the world bumps along between such moments of hope and long periods of intellectual castration."

News coverage of the Madrid discovery has been virtually nonexistent in this country. The news broke quietly on Feb. 29, 2000 with a story that ran once on the UPI wire about the Nature Medicine article. This writer stumbled on it through a link that appeared briefly on the Drudge Report web page. The New York Times, Washington Post and Los Angeles Times all ignored the story, even though its newsworthiness is indisputable: a benign substance occurring in nature destroys deadly brain tumors.

Raymond Cushing is a journalist, musician and filmmaker. This article was named by Project Censored as a "Top Censored Story of 2000."

AMBIEN

Zolpidem is a prescription drug used for the short-term treatment of insomnia (sleeping pill). It works quickly (usually within 15 minutes) and has a short half-life (2-3 hours), but will last longer in patients with hepatic failure. Some trade names of zolpidem are Ambien®, Stilnox®, Stilnoct®, or Myslee®.[1] Its sedative effects are similar to those of the benzodiazepines, but it is actually classified as an imidazopyridine, and the anticonvulsant and muscle relaxant effects only appear at 10 and 20 times the dose required for sedation, respectively.[2] For that reason, it has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are likely to induce one or more negative side effects, including hallucinations and/or amnesia.

Side-effects

Larger doses of the drug can result in a variety of unwanted side effects: hallucinations, delusions, poor motor coordination, euphoria (though many instead report dysphoric reactions) increased appetite, increased sex drive, poor judgement, and, following use, inability to remember events that took place while under the influence of the drug (anterograde amnesia). Some users take zolpidem recreationally for these side effects, however, it is not as common as with the benzodiazepines because of its unique mental imagery (which can distract the user from reality without actually producing genuine hallucinations) and irrational behaviour combined with the amnesia. Accordingly, Zolpidem can also become psychologically addictive if taken for extended periods of time, due to dependence on its ability to put one to sleep or to the unique sense of euphoria it can produce. Under the influence of the drug it is common to take more zolpidem than is necessary due to forgetting that one has already taken a pill. Users are advised to keep additional zolpidem away to avoid this risk.

BENADRYL


Diphenhydramine is widely used in nonprescription sleep aids (Nytol, Sominex, Unisom, Compoz, Excedrin PM, etc.) with a 50mg recommended dose mandated by the FDA. In the United Kingdom, Australia, New Zealand, South Africa, and other countries, a 50 to 100mg recomended dose is permitted.

Recreational drug users sometimes take several times the recommended dose of diphenhydramine in order to attain an intense hallucinogenic (more accurately, delirious) state. The mental effects are described by many as "dreaming while awake" involving visual and auditory hallucinations which, unlike those experienced with most psychedelics, often cannot be readily distinguished from reality. Many users report a side effect profile consistent with tropane glycoalkaloidal poisoning. This is due to antagonism of muscarinic acetylcholine receptors in both the central and autonomic nervous system, inhibiting various signal transduction pathways. In the CNS, diphenhydramine readily crosses the blood-brain barrier, exerting effects within the visual and auditory cortex, accounting for reported visual and auditory disturbances. Other CNS effects occur within the limbic system and hippocampus, causing confusion and temporary amnesia. Toxicology also manifests in the autonomic nervous system, primarily at the neuromuscular junction, resulting in ataxia and extrapyramidal side-effects, and at sympathetic post-ganglionic junctions, causing urinary retention, pupil dialation, tachycardia, and dry skin & mucous membranes. Considerable overdosage can lead to myocardial infarction, serious ventricular dysrhythmias, coma and death. Such a side-effect profile is thought to give ethanolamine-class antihistamines a relatively low abuse liability.

These are just some of the drugs I see advertised on a daily basis. Recreational overuse of these drugs, as you can see, impairs motor skills, causes hallucinogenic effects and temporary amnesia.... even death.

If these drugs could result in car accidents and chemical dependency, shouldn't they be labelled Class I controlled substances? Isn't that why THC is on the list?

Yep. Except Marijuana, as a substance, is not addictive. If a person has an addictive personality, anything can become addictive, including marijuana, but the substance itself is not addictive. Not like cigarettes. Not like alcohol.

Also, if you take enough of the drugs you mentioned, you'll die. You can smoke as much marijuana as you want, and the worst that will happen to you is you'll fall asleep.

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).

Hmmmm, sounds like alcohol to me - not to mention all the other 'good' drugs that HST mentioned

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.

I can attest to this safety issue: once I was coughing so hard, I vomited. Also, one other time, I stubbed my toe on the coffe table, cuz I was so high, man, that I like, didn't even know WHERE the coffee table was...

There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.

Available for just $150 per pill from your friendly neighborhood giant pharmaceutical company that pays the bills - but act now!!! For the first 100 callers, we will offer an addition 2 pills free!! Thats a $300 value!

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.

Now perhaps we could see a study by an organzation NOT financially supported by the pharm companies, and their political hacks. Or, heck, maybe even take a look at EVERY gov't. commision since NYC's Mayor Laguardia that returns a 'legalize it' opinion.

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.

Thats right, motherfuckers! When the people lead, the leaders will follow.

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.

At least pot brownies are still OK.

"Available for just $150 per pill from your friendly neighborhood giant pharmaceutical company that pays the bills - but act now!!! For the first 100 callers, we will offer an addition 2 pills free!! Thats a $300 value!"

:)