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A hundred years ago, products were sold with claims for which there were no demonstrable bases, and doctors had very little access to testing information about the products. Later, nationwide laws were established, but laws can be influenced by public fears, or by economic competition.
In the US there remains active political competition between the federal authority and "States' Rights." The original states were effectively independent countries after our revolution, until they became federated by the compromises of our Constitution.
Recently in California, State's Rights have been claimed for medical necessity, in the popular vote for "Proposition 215," which allows physicians to prescribe marijuana products where needed. This conflicts with Federal law, and is an important issue to be decided by the Supreme Court of the United States.
A most complete critical review of the issues involved in medical recognition is the National Academy of Sciences, Institute of Medicine, study:
"Marijuana and Medicine" (1999, ISBN 0-309-07155-0)
The introduction states, on page viii:
" Advances in cannabinoid science over the past 16 years have given rise to a wealth of new opportunities for the development of medically useful cannabinoid-based drugs. The accumulated data suggest a variety of indications, particularly for pain relief, antiemesis, and appetite stimulation. For patients who suffer simultaneously from severe pain, nausea, and appetite loss, such as those with AIDS or who are undergoing chemotherapy, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication."
In California, Lawrence Brooke and I were concerned that proper medication was not available to many, including elderly persons we knew who were suffering from untreated pain. We felt that the support given by medical specialists and the public to Proposition 215, as well as the technical information found in the National Academy of Sciences study, demonstrated both the need for and the healing potential of marijuana materials.
The NAS study criticized the known methods of administering cannabinoid advantages from marijuana. Although smoking is a simple, tested method of delivery, it presents serious problems for medical use: it is impossible for a doctor to prescribe an accurate dosage appropriate to the patient's condition; and, for some, smoking is unpleasant, it may be irritating to already damaged tissues, or it may be difficult for those physically impaired.
The NAS report mentions the possibility of an inhaler device such as is used for some other medications, for instance, against allergies and asthma. We felt this method also does not solve the problems of accurate dosage and physical handling for the patient.
We had been impressed by the success of the nicotine patch in aiding tobacco smokers to escape partially from their addiction, and felt that the cannabinoid oils extractable from the marijuana buds might well be offered to the body in a patch format. We felt this particularly appropriate when we learned of chemical analyses showing the presence of active ingredients, reproducibly, of over 25 per cent in this oil. The concentration and absorption rate of a patch oil can be assured to the prescribing physician, responding to the serious criticism of the Health Council of the Netherlands:
" The committee believes that physicians cannot accept responsibility for a product of unknown composition that has not been subjected to quality control."
Therefore, we took on the task of designing an adhesive patch, with a reservoir and adsorbant for the cannabinoid extract, aided by carriers to permit migration of the medication through the skin barrier. We examined the technical literature for previously studied good ideas, and were satisfied with our positive reports from test subjects.
We were advised by our specialist in patent law that our approach was sufficiently innovative that a patent description and claims should be registered. This route also amounts to a public declaration that medical help is possible and is on the way.
It was only after the patent number 6113940 was granted that we realized that the granting is also a partial recognition by our government of the medical value of this invention. Much of the Federal government's opposition to doctors' recommendations stems from its formal claim that there is no medical value in such a product. This is a principal issue of a "Schedule I" definition, which can only be changed by the following steps, as quoted in the NAS report:
" The substance's chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized."
The patch makes dosage controllable and reproducible.
" There must be adequate pharmacological and toxicological studies done by all methods reasonably applicable on the basis of which it could be fairly and responsibly concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder."
The patch provides a means for testing, both for safety and for applicability to several disorders.
" There must be adequate, well-controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of which it could fairly and responsibly be concluded by such experts that the substance will have its intended effect in treating a specific, recognized disorder."
Without some means for use by qualified physicians and their patients, these requirements cannot be satisfied!
" The drug must have a New Drug Application (NDA), approved by the Food and Drug Administration .... "
" In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available in sufficient detail to permit experts, qualified by scientific training and experience, to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder."
Our understanding is that there is much recorded success from informal use of marijuana cannabinoids in medicine, over the years, centuries, even longer.
Much historical medical information can be found at:
www.farmacy.org
Lawrence Brooke and I are inventors of this patch patent, but we are not pharmaceutical manufacturers. So we plan to work with an experienced patch manufacturer to make the cannabinoid patch available.
As hydroponic enthusiasts, we feel confident that hydroponic growth of this and of other plant-based medicines will provide the reliable, active products required by doctors and the public.
Aqueous hydroponic media can easily be controlled to provide optimum mineral and organic nutrition which the many species and varieties of medicinal plants require.
Medical acceptance of this treatment for severely distressed patients has no effect on the status of recreational use of marijuana or marijuana derivatives.
It does make possible a scientific study of the effects as found in these patients.
In order to respond to the fundamental question: is marijuana more dangerous than the currently legally tolerated alcohol, tobacco, caffeine, etc., medical evidence from a few thousand patients can finally yield plausible results based on observations and experience rather than bias. As a scientist, I value the answer to the basic question concerning the level of danger, whatever the result.
The cannabinoid patch can be a medically effective treatment for serious ailments. It offers a form that permits accurate prescription dosages.
Acceptance by the United States Patent Office is a first step toward medical acceptance as prescribed in the National Academy of Sciences study and report.
Further development to a manufactured medication must involve the established pharmaceutical industry.
Hydroponically grown medicinal plants can provide predictable, reliable, dosage forms.