INVOLVING THE USE OF MEDICAL CANNABIS:
WHY ISN'T MEDICAL MARIHUANA FDA APPROVED?
Because it's Effectively Against the Law to do medical research on Medical Marihuana and has been for the last 30 years. Simply put, NO medical research, NO FDA approval. This fact alone should raise some kind of red flag somewhere within the reader. WHY would the Federal Government want to outlaw medical research period? I mean, I could see it if Medical Marihuana were some kind of new bacteria from Mars, something that could endanger the whole planet, but a medicinal plant that's been around since day one? Something smells rotten in Denmark, I say.
HOW IS THIS POSSIBLE?
The answer is simple, the Narc's who have a vested self interest in NEVER, never allowing for its medical use, also have veto power over who can and who cannot do research. Let me explain; let's say that for whatever reason, you wish to do research on aspirin. Simply done, you just take some off the shelf and start in. However, with Medical Cannabis (a control substance) you first have to obtain a permit from the Narc's to even posses, let alone be able to obtain legal Medical Marihuana. And here's the catch, they simply don't give these permits out.
In fact, since the passage of the Federal Control Substances Act (1970), all the way up until California passed Prop-215 legalizing Medical Cannabis under their state laws, NONE, none at all, were issued. Now, true, the Narc's did (very reluctantly) give out permits to do SAFETY RESEARCH on Cannabis (obviously with the hopes of finding out something wrong), but it is a historic fact that they never allowed for any kind of FDA approval type of research to be done. Again, NO Medical Research, NO FDA approval.
And things have gone downhill from there-on-in, according to Chemical Heritage Magazine:
"Today, American researchers who wish to obtain legal cannabis for scientific study must apply to the National Institute on Drug Abuse (NIDA), which maintains a government-funded, 1.5-acre marijuana farm in Oxford, Mississippi. Compared with street marijuana, however, the government's plants are low in cannabinoid content, and some researchers have also complained of the institute's slow and seemingly arbitrary decisions. In 1994 Donald Abrams, a professor of medicine at the University of California, San Francisco, proposed to study the effects of smoking cannabis on HIV-related weight loss, but his application was rejected by NIDA, even though it had been approved by the U.S. Food and Drug Administration. When he then resubmitted his proposal, this time emphasizing the drug's potential negative effects, NIDA not only approved the study but also provided him with nearly a million dollars in funding. Another researcher, Lyle Craker of the University of Massachusetts-Amherst, applied to the Drug Enforcement Administration in 2001 for the right to grow cannabis for research purposes as a way of sidestepping these potency and access issues. For three years he heard nothing, until a federal court ordered the Drug Enforcement Administration to respond. They said no, so he sued them. That case is still under way." . . . . "The chill affected researchers as well as clinicians. Medical journals published dozens of studies before the tax act but few after its enactment. As researcher Lester Grinspoon noted, "virtually no medical investigation of cannabis was conducted for many years" as a string of additional laws, including the 1951 Boggs Act and the 1970 Controlled Substances Act, further deterred research." ---T. Geller - Chemical Heritage MagazineBut this "No Medical Research Policy" on the part of the Drug Police is nothing new. Even before the creation of the DEA and the passage of the Control Substances Act, the old FBN (Federal Bureau of Narcotics), had the same sort of policy in place. According to Larry Sloman:
"This hands-off policy was also the case with respect to the legitimate inquiries about research with marijuana. The commissioner's [Harry Anslinger our nations first Drug Czar] position was that there was no legitimate use for it, so he would never allow any applicants to be recognized. Every so often some university would submit an application to grow some marijuana plants or do a botany experiment on the medicinal uses of marijuana. Anslinger would rely heavily on a man---whose name escapes me---who knew the Commissioner's policy and who would come up with a scientific reason why the application should be denied. A nice old man who played ball and was very credible." ---Reefer Madness, a History of Marijuana by Larry "Ratso" Sloman p212/213But, be that as-it-may, (and fortunately for us), the whole of the Drug Police apparatus had what amounts to a complete brake-down in the late 1960's, early 1970's. Harry Anslingers' old Federal Bureau of Narcotics had come under close-scrutiny (a/k/a -- its lies had finally caught up with it) and was abolished. It its place the DEA (Drug Enforcement Agency) was created and took its place. However during the transition period, a strange thing happened. Essentially (for a very short period of time), their literally was no one around to veto such research, etc., etc.
The following (for the most part) was taken from an old website - http://:www.lindesmith.org:
As can see from this compilation there has been a tidal wave of published research demonstrating marijuana's medical usefulness. Indeed, it is stated in the research studies conducted by various states under FDA protocol that the research being conducted was in the final phase of approval by the FDA. When the federal government stopped research on the medical use of marijuana in 1992 the drug had nearly completed the requirements for new drug approval.
Drug Czar Barry McCaffrey's assertion in his Scripps-Howard News Service column that No clinical evidence demonstrates that smoked marijuana is good medicine" is inconsistent with the facts. Whether this is an intentional deception, as part of the federal government's stated public relations offensive against medical marijuana, or whether it is based on ignorance does not matter. The reality is General McCaffrey's statements are not consistent with the facts.
The research reprinted in this compilation includes randomized, double-blind, placebo controlled studies, research using a variety of objective and subjective measurements and a range of research protocols. Doctors have a sound basis on which to recommend marijuana for use by their patients. Indeed, physicians are well aware of the medical value of marijuana. One study, a scientific survey of oncologists found that almost one half (48 percent) of the cancer specialists responding would prescribe marijuana to some of their patients if it were legal. In fact, over 44 percent reported having recommended the illegal use of marijuana for the control of nausea and vomiting.
This publication addresses research that has been published in three areas: cancer, glaucoma and muscle spasticity. All of the materials herein were published after 1970. The materials enclosed are either published in peer review journals, government publications or are reports submitted to the federal government by state agencies.
PUBLISHED RESEARCH STUDIES
There have been several studies which have been published which focus on the medical value of smoked marijuana and cancer therapy. These include:
Vinciguerra et al., Inhalation Marijuana as an Antiemetic for Cancer Chemotherapy,"The cancer research is relevant to marijuana as a useful therapy for AIDS patients. The same symptoms are needed to be controlled among AIDS patients: appetite, nausea and vomiting. There have been recent reports of AIDS and marijuana in the literature. A study with THC found relief of nausea and significant weight gain in 70 percent of patients. However, one- fifth of the patients did not like the psychoactive effective of synthetic THC, indicating marijuana is likely to be preferred by AIDS patients. This is consistent with a survey of people with AIDS conducted by a researcher in Hawaii in 1996. The survey found that 98.4 percent of AIDS patients were aware of the medical value of marijuana and 36.9 percent had used it as a antiemetic. Of those that had used is 80 percent preferred it over prescription drugs including synthetic THC. A study being conducted in Australia of HIV patients found that those who use marijuana had a better quality of life. In particular, those that were HIV positive for over ten years found marijuana to be critical. One patient told the researcher that he considered marijuana to [be] his savior."
REGARDING GLAUCOMA, there have been published studies which consistently show that marijuana is effective in lowering intraocular eye pressure. Heightened intraocular eye pressure is the cause of glaucoma. Thus published evidence indicates marijuana preserves the vision of people with glaucoma.
Finally, REGARDING THE CONTROL OF MUSCLE SPASM there is published literature demonstrating marijuana to be effective in controlling convulsions. The control of muscle spasm is important to patients with multiple sclerosis, epilepsy, spinal cord injury, paraplegia and quadriplegia.
STATE HEALTH DEPARTMENT STUDIES
In addition to the published research there have been a series of six studies conducted by state health departments under research protocols approved by the U.S. Food and Drug Administration.The focus of these studies, conducted by six state health agencies was the use of marijuana as an anti-emetic for cancer patients. The studies, conducted in California, Georgia, New Mexico, New York, Michigan and Tennessee, compared marijuana to antiemetics available by prescription, including the synthetic THC pill, Marinol. Marijuana was found to be an effective and safe antiemetic in each of the studies and more effective than other drugs for many patients.
This study involved 250 patients.The study compared marijuana to THC capsules. The research protocol was approved by the FDA in 1978. In order to participate in the research the patient had to be referred by a physician and had to have failed on at least three other antiemetics. Patients were permitted to choose marijuana or the THC pill. Both objective (e.g., frequency of vomiting, amount of vomiting, muscle biofeedback, blood samples and patient observation) and subjective measures were made to determine the effectiveness of the drug.
The study concluded that marijuana was not only an effective antiemetic but also far superior to the best available conventional drug, Compazine, and clearly superior to synthetic THC pill." The study found that [m]ore than ninety percent of the patients who received marijuana reported significant or total relief from nausea and vomiting." The study found no major adverse side effects. Only three patients reported adverse reactions, none of these reactions involved marijuana alone. The 1984 report concluded the data accumulated over all five years of the program's operation do show that marijuana smoked resulted in a higher percentage of success than does THC ingested."
The Michigan research compared marijuana to Torecan. It involved 165 patients. Upon admission to the program patients were randomized into control groups with some randomized on the conventional antiemetic Torecan and the remainder randomized to marijuana. When failure on the initial randomized drug occurred, patients could elect to crossover to the alternate therapy. This procedure allowed the Michigan Department of Health to evaluate how well patients responded to both drugs and allowed patients to register their preference.
The Michigan study reported 71.1 percent of the patients who received marijuana reported no emesis to moderate nausea. Ninety percent of the patients receiving marijuana elected to remain on marijuana. Only 8 of 83 patients randomized to marijuana chose to alter their mode of antiemetic therapy. This was almost the inverse of patients randomized to Torecan, there more than 90 percent - 22 out of 23 patients - elected to discontinue use of Torecan and switched to marijuana. Very few serious side effects were found related to marijuana use. The most common side effect was increased appetite - reported by 32.3 percent of patients - this was a positive effect. The most common negative effects were sleepiness, reported by 21 patients and sore throat, reported by 13 patients.
This study involved an evaluation of 27 patients. The patients had all failed on other forms of antiemetic therapy including oral THC. The study found an overall success rate of 90.4 percent for marijuana inhalation therapy. In comparison it found a 66.7 percent success rate for THC capsules. In the under 40 age group, the study found a 100 percent success rate for marijuana inhalation therapy.
The report concludes:
We found both marijuana smoking and THC capsules to be effective anti-emetics. We found an approximate 23 percent higher success rate among those patients administered THC capsules. We found no significant differences in success rates by age group. We found that the major reason for smoking failure was smoking intolerance; while the major reason for THC capsule failure was nausea and vomiting so severe that patient could not retain the capsule.
In describing the purpose of the marijuana research program the New York Department of Health stated: [t]he program is a large-scale (Phase III) cooperative clinical trial . . . ." The central question addressed is [h]ow effective is inhalation marijuana in preventing nausea and vomiting due to chemotherapy in patients . . . who have failed to respond to previous antiemetic therapy?"
By 1985, the New York program had extended marijuana therapy to 208 patients through 55 practitioners. Of that, 199 patients were evaluated. These patients had received a total of 6,044 NIDA-supplied marijuana cigarettes which were provided to patients during 514 treatment episodes.
In percentage terms the results were stunning: North Shore Hospital reported marijuana was effective at reducing emesis 92.9 percent of the time; Columbia Memorial Hospital reported efficacy of 89.7 percent; Upstate Medical Center, St. Joseph's Hospital and Jamestown General Hospital reported 100 percent of the patients smoking marijuana gained significant benefit.
The report concludes: Patient evaluations have indicated that approximately ninety-three percent of marijuana inhalation treatment episodes are reported to be effective' or highly effective' when compared to other antiemetics." The New York study reports no serious adverse side effects. No patient receiving marijuana required hospitalization or any other form of medical intervention. See, Evaluation of the Antiemetic Properties of Inhalation Marijuana in Cancer Patients Receiving Chemotherapy Treatment," New York Department of Health, Office of Public Health (Annual Reports).
The Georgia program evaluated 119 patients. It compared THC to standardized smoking of marijuana and with patient-controlled smoking. To enter the program a patient had to have failed on other antiemetics. Patients were randomized to either patient-controlled smoking of marijuana, standardized smoking of marijuana or THC pills.
The report found that both THC and marijuana were effective in providing antiemetic relief for patients who were previously unresponsive to antiemetics. The rate of success was 73.1 percent. Patient controlled smoking of marijuana was successful in 72.2 percent, standardized smoking was successful in 65.4 percent and THC was effective in 76 percent of the cases. In comparing the reasons for failure between marijuana and THC the report found:
The primary reasons for failure of THC capsules were due to either adverse reaction (6 out of 18) or failure to improve nausea and vomiting (9 out of 18). The primary reason for failure of smoking marijuana were due to smoking intolerance (6 out of 14) or failure to improve the nausea and vomiting (3 out of 14).
California conducted a series of studies from 1981 through 1989. Annual reports were submitted to the FDA, state legislature and Governor. Each year approximately 90 to 100 patients received marijuana. The California research was described as a Phase III trial."
The study protocol preferred THC pills by making it much easier for patients to enter that portion of the study. Patients who received marijuana had to be over 15 years of age (the THC pill patients had to be over 5 years of age); had to be marijuana experienced, use the drug on an in-patient basis (patients could only use marijuana in the hospital and not take the medicine home) and had to be receiving rarely used and severe forms of chemotherapy. Thus, the design of the study did not favor marijuana.
Even with this built in bias against marijuana, the study consistently found marijuana to be an effective antiemetic. In 1981 the California Research Advisory Panel reported: Over 74 percent of the cancer patients treated in the program have reported that marijuana is more effective in relieving their nausea and vomiting than any other drug they have tried." In 1982, a 78.9 percent effectiveness rate was found for smoked marijuana. By 1983 the report was conclusory in its findings, stating:
The California Program also has met its research objectives. Marijuana has been shown to be effective for many cancer chemotherapy patients, safe dosage levels have been established and a dosage regimen which minimizes undesirable side effects has been devised and tested.
The California Research Advisory Panel continued to review data on marijuana until 1989 with similar results.
Studies of Marijuana Constituents In addition to research on smoked marijuana there has been a host of research on constituents of marijuana. This research is relevant in measuring the effectiveness of marijuana.
The drug for which there has been the most research is the THC pill. This pill contains pure delta-9- tetrahydrocannabinol in sesame seed oil. This substance is now scheduled in Schedule II of the Controlled Substances Act. When the drug was rescheduled the Food and Drug Administration acknowledged: The effects of pure THC are essentially similar to those of cannabis containing THC in equivalent amounts." Thus, the federal government has acknowledged that THC, which is available as a medicine, adequately emulates the effectiveness to marijuana. In fact, the research described above shows that marijuana is in fact a more effective medicine than the THC pill.
The research which compares marijuana to the THC pill found that patients preferred marijuana to THC and that marijuana was more effective at treating symptoms. State studies in Michigan and New Mexico found that most patients who tried THC chose to use marijuana instead. The most common reasons for this choice was because THC was more psychoactive, erratic and unpredictable. Patients found they had more control and a quicker response with smoked marijuana than with oral THC. Patients found it difficult to swallow the pill when they were nauseous. Patients were also able to limit their use of marijuana to only the amount needed when it was smoked. For many cancer and AIDS patients this can involve smoking a very small quantity of the drug. With the THC pill the patient must ingest the whole pill and therefore cannot control the dose.
The Chang study published in The Annals of Internal Medicine found that marijuana was more consistent than the oral THC pill. As they note this was consistent with the observations of Sallan and his colleagues in their study published in The New England Journal of Medicine, Alfred Chang et al. stated:
Sallan and his co-workers considered inadequate drug absorption as a possible contributing factor to the lack of antiemetic response seen in some patients. We concur, since THC plasma concentrations appeared to be causally related to an antiemetic response in our study. To avoid this problem, we switched patients to the inhalation route of drug administration when vomiting occurred. Inhaled marijuana results in the same psychological effects as orally administered THC. In our patient populations, smoked THC was more reliable than oral THC in achieving therapeutic blood concentrations.
A final reason why marijuana cigarettes are superior to the THC pill is because it is not only delta-9-THC which provides positive medical effects. The bibliography includes research involving other components of marijuana, including various cannabinoids and delta-8-THC. This research indicates that it is not only delta- 9-THC which has beneficial medical effects but other components of marijuana. Smoking marijuana provides the patient with the benefits of the combination of marijuana's active ingredients as opposed to the effects of only THC.
ADDITIONALLY, it should be pointed out that there are numerous older (19th century -early 20th century) studies that have been done and published on the subject. This books appendix contains a listing of numerous (pre-1937) Medical Cannabis Articles.
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