What did the US Government Know About CBD and Epilepsy in the Early 1970's?
Originally published on Wordpress Dec 5, 2020
In the early 1970s, Dr. Robert Heath conducted experiments on humans and rhesus monkeys as he administered Cannabis to them at Tulane University. The humans were epileptic.
The text below was taken from a publication of the United States Senate after their hearings: MARIHUANA-HASHISH EPIDEMIC AND ITS IMPACT ON UNITED STATES SECURITY, in May-June 1974. The hearings were before the Internal Security Subcommittee of the Committee on the Judiciary, chaired by James O. Eastland (D- Mississippi).
In the Tulane laboratories, data gathered from a small number of uncontrollable epileptic patients who were undergoing brain surgery for their epilepsy, have revealed consistent alterations in function of specific deep brain sites. Techniques involved in the treatment of their epilepsy were rather unique. Electrodes were implanted into specific structures deep in the brain as well as over the surface. With these techniques we were able to obtain information on brain function that could not be obtained with the more conventional recording techniques. Some of the patients involved were chronic marihuana smokers. During the course of their treatment, we permitted them to smoke marihuana cigarettes while recordings were being made, with these special techniques, from otherwise unavailable brain sites. The deep brain sites affected by the smoking were those where we had, over the years, made correlations between brain activity and alerting, awareness, and feelings of pleasure.
Dr. Heath's work at Tulane University was funded by the National Institute of Mental Health (NIMH). The NIMH also funded the University of Mississippi to grow the Cannabis used for testing. Dr. Robert Heath described himself as "psychiatrist and neurologist and chairman of the Department of Psychiatry and Neurology at Tulane University School of Medicine."
Chairman Eastland's Internal Security Subcommittee provided background on the Cannabis research at the NIMH and the University of Mississippi:
it is only within recent years—in fact, since 1970—that accepted procedures for the quantitative analysis of marihuana have been established and that carefully standardized strains of marihuana have become available for research purposes. In the absence of standardized research materials and standardized analytical procedures, research scientists in the past, working with the utmost conscientiousness, often came up with sharply conflicting findings. Within the last few years, thanks to a remarkable program that has been developed at the University of Mississippi (2), marihuana research is today moving forward without these handicaps—and, as this volume of testimony dramatically demonstrates, this research is producing some highly dramatic results.
(2) The program Is known as the Marihuana Project of the Research Institute of Pharmaceutical Sciences, which is part of the School of Pharmacy at the University of Mississippi. The program was established in 1968, as part of a national program of research, by Dr. Coy Waller, formerly Vice President in Charge of Research at Meade-Johnson and consultant to the National Institute of Mental Health, who today serves as the Director of the Research Institute. The first Director of the Marihuana Project, from 1968 to 1971, was Dr. Norman Doorenbos. Since 1971, it has been under the direction of Dr. Carlton Turner, who also serves as Associate Director of the Research Institute.
In addition to standardizing the marihuana used for research purposes, Dr. Turner's scientists have developed analytical methods which enable them to give accurate readings on ten different cannabinoids contained in marihuana samples—a few years ago, they were able to analyze for only three cannabinoid components. The marihuana the Institute cultivates is now used routinely for all research projects sponsored through the National Institute of Mental Health, while the United Nations Narcotics Commission has recommended that the analytical procedures developed at the University of Mississippi be used worldwide.
If today we know far more about marihuana than we did two or three years ago, it is thanks in large measure to the pioneering work done at this internationally unique research center.
(The 3 cannabinoids known before the NIMH studies began were cannabidiol (CBD), cannabinol (CBN), and tetrahydrocannabinol (THC). Their discovery is given credit to Dr. Roger Adams at the University of Illinois). SOURCE
As Dr. Heath administered cannabis to his subjects, he recorded their brain waves with an EEG. The Senate published the EEG results of the rhesus monkeys before and after they were administered marijuana.
The Senate did not publish the EEGs of the humans with epilepsy who were given Cannabis to smoke. I find it impossible to believe that Dr. Heath could not have noticed the positive effects of CBD (or cannabis in general) on the patients with epilepsy with the level of monitoring he performed on them. Heath used deep brain implants of electrodes and EEGs. Dr. Heath was eminently qualified to interpret the results of EEGs on epileptic patients in the early 1970s. The Controlled Substances Act of 1970 made Cannabis illegal for most all purposes, including medical, but Dr. Heath never said "hey this stuff could be beneficial for people with Epilepsy" based on his research.
Heath specifically sought out patients with Epilepsy who also smoked Cannabis. Heath called them "chronic marihuana smokers." There is a subtle implication in Heath's language that the use of Cannabis had caused Epilepsy in people, not that people used Cannabis because they found it to be medically beneficial for Epilepsy. Reversal of cause and effect and other forms of disinformation are present throughout the entire scientific community's testimony to the Senate in 1974. Many scientists of various fields testified.
Heath: Some of the patients involved were chronic marihuana smokers. During the course of their treatment, we permitted them to smoke marihuana cigarettes while recordings were being made, with these special techniques, from otherwise unavailable brain sites.
Another example of disinformation present in the Senate document concerns the cause of death of two rhesus monkeys. The government described the cause as "respiratory complications," which is true in a sense, but disguised the fact that the scientists had deliberately killed the monkeys by forcing them to inhale heavy Cannabis smoke without oxygen. Lack of oxygen and presence of carbon monoxide were the primary cause of death. The pattern and specific method in the death of brain cells would have been the subject of interest to these scientists. They would have also killed other "baseline" monkeys by a similar asphyxiation method and compared the results, only these would not have been administered Cannabis. (By 1977 the United States government was importing 34,000 primates a year). SOURCE. Heath's testimony on the "respiratory complications" is below.
Heath: With regard to physical complications in this experiment, two monkeys out of the 10 died during the course of these studies. Their recording and behavioral data are included in the effects cited herein. One monkey died 3 1/2 months after onset of the experiment and the other animal died after 5 1/2 months after the onset. One had implanted electrodes and the other was unoperated. Both were in the heavily smoked active marihuana group (chronic exposure) and both died of respiratory complications.
The brains of these two animals have been studied histopathologically and the preliminary report indicates minimal structural alteration of cells in the septal region of the brain.
Our protocol requires us to continue to study the behavioral and recording changes in the surviving monkeys for 1 month beyond the drug exposure period of 6 months. At that point, the monkeys will be sacrificed and their brains will be carefully perused and prepared for study by electron and light microscopy to yield more finite data about structural changes that may have been induced in association with the consistent physiological alterations that I have described.
Dr. Heath laid out the government's position on Cannabis in no uncertain terms, based in large part on the false premise of the cause of death of the rhesus monkeys: "When I first began to work with marihuana I was much in keeping with the ideas that were prevalent in the scientific arena at that time that marihuana seemed to be a relatively innocuous agent. It produced relaxation and no one had established that it produced any significant damage, nor that it was strictly addictive. But as I have gone on with the experiments observing the effects in humans, both clinically and as part of the research program, I began to feel that this is a very harmful drug. This drug seems to produce real and significant damage, and my data, I believe, substantiates the fact that this is a drug which has strongly deleterious effects with probable destructive effects on the brain in heavy users. He didn't mention the fact that "heavy use" meant being strapped down with a gas mask on that only blew smoke.
It seems to me that Heath's comment "minimal structural alteration of cells in the septal region of the brain" suggests that Cannabis had protective properties for this area of the brain as the monkeys were asphyxiated.
The Alliance for Human Research Protection (AHRP) has further information on Dr. Heath's background.
Other CBD and Epilepsy Research
These are some highlights of Cannabidiol (CBD) and Epilepsy research that I found.
August 16, 1940. Roger Adams, of the University of Illinois, files for a Patent of his method to isolate CBD. SOURCE. "Red Oil" was a name commonly given high quality hashish extract when it was refined sufficiently to remove oxides. There is another version of Cannabis Red Oil, apparently. "Red Oil, was developed by the U.S. Army for trials in psychological combat." SOURCE They called it EA 1476. It had some synthetic modifications. It's hard to say what exactly Adams was using for Red Oil, but hashish extract would have had plenty of CBD in it.
1946. "CBD research began in 1946 when Dr. Walter S. Lowe began conducting laboratory tests on the effects of CBD on animals. Lowe’s laboratory tests resulted in proving that CBD had no mind-altering effects." SOURCE (Need an original source on Walter Lowe's 1946 tests).
1949. "An article in 1949, buried in a journal of chemical abstracts, reported that a substance related to THC controlled epileptic seizures in a group of children more effectively than diphenylhydantoin (Dilantin(R)), a most commonly prescribed anticonvulsant" SOURCE. The original source is: Davis, J. P., and Ramsey, H. H.: "Antiepileptic action of marihuana-active substances," "Federat. Proc.," 8:284-85, Mar. 1949.
1970. The Controlled Substances Act of 1970 makes Cannabis illegal for medical use.
Early 1970s. "several animal studies in the early 1970s showed that CBD had activity against epilepsy" SOURCE
1980. Raphael Mechoulam, of the Weizmann Institute in Rehovot, Israel, sent CBD to Brazil for a study on Epilepsy. Mechoulam's comments on the study are below. SOURCE The results of the 1980 Epilepsy/CBD study in Brazil is referenced as Cunha J. M., Carlini E. A., Pereira A. E., Ramos O. L., Pimentel G., Gagliardi R. et al. Chronic administration of CBD to healthy volunteers and epileptic patients. Pharmacologia 1980; 21: 175–85
Mechoulam: Many years previously, in a clinical trial in Brazil, headed by E. Carlini, we found that it is a good anti‐epileptic agent. We then prepared and sent to Brazil several hundred grams of CBD, which apparently were not used fully in the epilepsy trial, and the Brazilian group are still using it in research, which has shown lowering of anxiety and therapeutic effects in schizophrenia; and the Mexican group of Murillo‐Rodriguez has presented evidence that it leads to awakening.
Referencing the same 1980 study that Mechoulam referenced, the International League Against Epilepsy (ILEA) summarized the study: a small clinical trial saw reduction in seizure frequency in 7 of 8 patients with epilepsy taking CBD, compared with 1 of 8 taking placebo. SOURCE
April 21, 1998: The United States government files for a Patent of CBD. SOURCE
4.12.19. Silvestro et al published Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials.
The purpose of this paper is to evaluate the use of CBD, in addition to common anti-epileptic drugs, in the severe treatment-resistant epilepsy through an overview of recent literature and clinical trials aimed to study the effects of the CBD treatment in different forms of epilepsy. The results of scientific studies obtained so far the use of CBD in clinical applications could represent hope for patients who are resistant to all conventional anti-epileptic drugs.
Their paper included tables with the results of many tests that showed that the use of CBD greatly improved symptoms of patients with Epilepsy who were not responding well to AEDs, which is great of course. But why must CBD be tested in concert (as an "adjunct") with the other chemicals? A more telling test would be to have one group use CBD only, and one group use the various chemotherapies, and compare the results. Other considerations favor CBD over AEDs. Commonly used AEDs have side effects that CBD does not. SOURCE. CBD is more affordable. What medical premise supposes that CBD should not be the first-line treatment for Epilepsy, instead of an "adjunct" to the expensive drugs only after they do not work?
Meanwhile, the growth of the anti-epileptic drug (AED) market is forecasted to grow steadily.
SEATTLE, April 09, 2020 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the global anti-epileptic drugs market is estimated to be valued at US$ 7,155.6 million in 2019, and is expected to exhibit a CAGR (Compound Annual Growth Rate) of 6.6% over the forecast period (2019-2027). ... owing to increasing launches of drugs. For instance, in February 2019, Teva Pharmaceutical Industries Ltd. launched generic version of Sabril (vigabatrin) tablets in the U.S. Sabril (vigabatrin) is indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory complex partial seizures (CPS). ... Major players operating in the global anti-epileptic drug market include— Novartis AG, GlaxoSmithKline Plc, Johnson & Johnson Service, Inc., Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Sanofi S.A., Sumitomo Dainippon Pharma Co., Ltd., Mylan N.V., Bausch Health Companies Inc., and UCB S.A. SOURCE
SUMMARY
I take it as fact that the US government knew that CBD had medical benefits of Epilepsy during the period 1970 - 2018, which is the period when all forms of Cannabis, including CBD, were illegal. This is the period between the Controlled Substances Act of 1970 and the Farm Bill of 2018 which legalized use of Cannabis that contains less than .3% THC.
Charles Wright