NJMS Won't Certify and A-804 Won't Help BUT More Kids, Mr. Wilson Smoking "safe","medical" marijuana. (updated 12-17-09)
All earlier evidence aside (updated further below) how can NJ legislators, intentional or not, encourage vulnerable kids and desperate people like Mr. Wilson marijuana is a medicine and thus safe to smoke, when the NJ Medical Association will not, like F.D.A. approved medicines, certify its actual risks and it is actually a valid, accurate, and reliable treatment, nor determine the appropriate quality and dosage?
1. A study, compiled by the University of Michigan for the federal National Institute on Drug Abuse (A) found "...use of marijuana across all three grade-levels increased [over 46,000 8th,10th & 12th graders participated]. The study attributed the rise, at least in part, to the growing acceptance of marijuana use for medicinal purposes. That trend has made the drug appear less dangerous to teens, the study said. CSMONITOR, Daniel B. Wood, December 14, 2009. (B). This finding is consistent with the 2004 Pediatrics' technical report "Legalization of Marijuana: Potential Impact on Youth." It concludes the "Legalization of marijuana could decrease adolescents’ perceptions of the risk of use and increase their exposure to this drug. Furthermore, data concerning adolescents’ use of the 2 drugs that are legal for adults (alcohol and tobacco) suggest strongly that legalization of marijuana would have a negative effect on youth." (C) (pdf).
2. The irony associated with this perception is its disconnect with the refusal of the New Jersey Medical Society to certify the risks and benefits for any use of marijuana as a medicine. In fact, the Medical Society of New Jersey is said to have relaxed its opposition to the state bill after lawmakers removed provisions requiring doctors to certify the risks and benefits of medical marijuana. (D). And, of course, Assembly Bill A-804 expressly disavows any Government liability for any use.(E).
The contrast is more obvious when compared to Pennsylvania and Wisconsin. The Pennsylvania Medical Society has not taken a position on the state measure, but it pointed lawmakers to American Medical Association policy calling for further research into medical marijuana's efficacy. (D). Dr. Michael Miller, who was representing the Wisconsin Medical Society, said despite the growing popularity of legalizing medical marijuana both in the state and across the country, it’s not an effective pain killer and smoking it causes other health problems. (F). Miller also told lawmakers the Wisconsin Medical Society opposed the bill because drug approvals should be based on science and left to the Food and Drug Administration. (G) .
3. Which leads us to Mr. Wilson. Based on press reports of the facts it appears Mr. Wilson has a mild form of an admittedly horrible chronic illness, Multiple Sclerosis. Desperate for relief he was growing marijuana because (1) he could not afford other medications, (2) he believed it to be a "safe" "medicine", and there is no indication his intent was other than for self medication. Based on these facts one would hope whoever is governor would effect a one off pardon as a source of mercy but also as a warning it is not a defense. This is not to relieve Mr. Wilson of his responsibilty. He had to get the seeds from someone and it is equally possible kids or even drug dealers could have found his grow site. And, what about the small bag of illegal, hallucinogenic mushrooms. (H).
That said however, however, pending legislation would not substantially aid Mr. Wilson. Marijuana is generally discussed in terms of an ounce (google search). Assuming there was a medical exemption, which assumes it really is a medicine, Mr. Wilson had 17 plants, which is + / - 120 ounces (google search). That's 10 ounces per month. A-804 allows a "patient" one (1) ounce per 30 day period. For comparison, a .6 ounce pouch of tobacco makes 40 cigarettes. Thus 10 ounces roughly equals 800 cigarettes or 2 cartons per month.
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Smoking A Joint Doesn't Make Marijuana Medicinal- It Does However Diminsh Medical Science and Scientific Certainty.
Said differently, the next time you're in a drug store - look around at the safe, accurate, valid and reliable F.D.A. approved medicines, both prescription and over the counter, covering a wide range of illnesses. Then ask yourself a question - do you want science corrupted by the emotional, anedotal, preclinical evidence (Ephedirin, the Oxygen Vitamin, and early cigarrette (Old Gold) promotions, etc.) offered by special interest groups or the dispassionate scientific certainty associated with the expert scientific process devoid of political considerations to be the standard for determining both the medications and amounts of medications the public uses?
Politics cannot be allowed to corrupt science. The issue of whether marijuana has a medicinal use is a question for science to be answered with scientific certainty and not a popularity contest resulting from the political promotions of special interests or a tool of litigation public relations. If the interest in marijuana is indeed medicinal then its time to walk the talk by deferring any pending legislation until scientific inquiry (such as the F.D.A. Sativex trials) demonstrates its use is safe, valid, accurate and reliable as well as administratively manageable. In short, the dispassionate process of scientific certainty is in the interest of those who truly suffer while preventing those with less altruistic motives from using people with severe illnesses as human shields.
1. Smoking a joint does not make marijuana medicinal. Neither the MS Society or American Cancer society advocates its use. The November 21, 2009 LA Times Editorial "The AMA's Reversal on Marijuana" (pfd) specifically notes: For all the debate over whether marijuana has medicinal value, arguments that the drug has significant palliative properties or that it has none suffer from the same flaw: There's little scientific proof either way."
The American Medical Association, LA Times & Washington Post are calling for extensive federal research of marijuana's medicinal purpose(s). The A.M.A. House of Delegates has called "for further adequate and well-controlled studies of marijuana and related cannabinoids in patients who have serious conditions for which preclinical, anecdotal, or controlled evidence suggests possible efficacy and the application of such results to the understanding and treatment of disease."
2. At the same time, the AMA specifically rejected state-based medical marijuana programs & the Washington Post editorial (Oct 25 "Questions About Pot") calls for a moratorium on new state programs.
"The AMA supports the concept of drug approval by scientific and regulatory review to establish safety and efficacy, combined with appropriate standards for identity, strength, quality, purity, packaging, and labeling, rather than by ballot initiative or state legislative action." ... Unoffical [ AMA Witholding from publication to allow peer review]. AMA Report 3 of the Council on Science and Public Health. (pfd) (last page)
Accordingly, "the patchwork of state-based systems that have been established for “medical marijuana” is woefully inadequate in establishing even rudimentary safeguards that normally would be applied to the appropriate clinical use of psychoactive substances. " Executive Summary, AMA Report 3 of the Council on Science and Public Health.
Indeed, even The Washington Post (Oct 25 "Questions About Pot") is calling for a moratorium on new state programs.
3. The F.D.A. is currently near the end of extensive clinical trials of Sativex for cancer and M.S.
It is the AMA's position that smoking it is not a solution:
"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." Unoffical version of AMA Report.
Dr. Edward Langston, an AMA board member, states more studies, in particular randomized, controlled trials, need to be carried out on smoked cannabis. According to Dr. Edward Langston the small number of that have been conducted in the past 30 years have been "insufficient to satisfy the current standards for a prescription drug product." LA TIMES, Medical marijuana gets a boost from major doctors group, 11-11-09.
Dr. Michael M. Miller, a psychiatrist who practices addiction medicine, proposed the amendment. "Smoking is a bad delivery system because you're combusting something and inhaling it," he said. LA TIMES, Medical marijuana gets a boost from major doctors group, 11-11-09 .
The October 25 Washington Post editoral article recognizes the medical marijuana controversy may be moot in the near future as a number of extensive FDA supervised clinical trials of a drug known as Sativex (cancer & MS) have ended or are near an end. Sativex meets a diverse range of criteria by delivering the cannabis product via an inhaler it allows a user to function "normally" because it relieves [1] the pain [2] without the "high" and [3] prevents the rapid deterioration to lung function associated with smoking marijuana.
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The Washington Post's Editors write in "Questions About Pot?" "More information -- good old-fashioned scientific information -- is needed before the federal government or more states formally endorse marijuana smoking for medicinal use. The Institute of Medicine, an arm of the National Academy of Sciences, in 1999 published what is widely considered to be the most comprehensive study; it was decidedly mixed, listing the many possible drawbacks of smoking marijuana, including respiratory problems, while noting that such use seemed to provide some patients with relief not obtained from pills containing marijuana's active ingredients.
More recently, Dr. Peter J. Cohen, an adjunct professor at the Georgetown University Law Center, noted in a 2009 law review article that reputable studies released in the past few years showed that patients with AIDS and hepatitis C experienced reduced pain and nausea and were better able to tolerate traditional treatment as a result of smoking marijuana. Yet these preliminary results -- as Dr. Cohen points out -- have not been subjected to rigorous testing by the Food and Drug Administration. The reason: A manufacturer must submit the drug for review before the FDA will tackle the assignment. So far, no such "manufacturer" has come forward.
The medical marijuana controversy may be moot in the near future because of a drug known as Sativex, a spray mist approved for conditional use in Canada and the United Kingdom that delivers the active ingredients found in marijuana. If cleared by the FDA, patients will have some confidence that it is safe and effective. Patients have the right to know if the same can be said about smoked marijuana."
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It should be said upfront that we strongly disagree with "Executive Branch nullification (as opposed to prosecutorial discretion)" of Constitutional legislation and Supreme Court review because it embodies the essence of "arbitrary government." It not only ignores the Constutional seperation of powers between the Executive and Congress and the Court, it shreds "our Federalsim", i.e. the Constitutional relationship between the Federal and State Governments. That said, however, and for the reasons set forth below, the Post's focus on science over interest group politics is compelling.
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Scientific Certainty of F.D.A. Sativex Trials Moots NJ's Compassionate Medical Marijuana Act If any decision concerning the medicinal use of marijuana is as simple as some suggest one must ask why the U.S. & U.K. National MS Societies & the American Cancer Society question its use and continue to withhold their approval. In reality there are many obstacles. For example, "Marijuana Smokers Face Rapid Lung Destruction -- As Much As 20 Years Ahead Of Tobacco Smokers." January 2008 Respirology. And, as the Center for Disease Control points out in its 09-04-09 MMWR weekly, eating marijuana gives rise to a seperate set of problems - including efficacy, doseage, duration, etc. Finally, people with MS have higher rates of depression and suicide compared to the general population. “Since marijuana can induce psychosis and anxiety in healthy people ... it was especially important to look at its effects on people with MS ... February 13, 2008, online edition of Neurology, the medical journal of the American Academy of Neurology.
George Washington University Constitutional law Professor Turley has commented the partisan political interests involved in the issue of marijuana for medicinal purposes has resulted in the major political party's acting in a manner that is completely at odds with their traditional view of the Constitution and the prevailing status of the defined Constitutional relationship between Federal and state governments. (1). So too, Georgetown University adjunct law professor Peter J. Cohen, an apparent advocate for marijuana, provides a substantive confirmation of the problem in his Utah Law Review article "Medical Marijuana: The conflict Between Scientific Evidence and Political Ideology. (2). In effect, Cohen agures any medicinal use must be determined soley by science while any recreational use is a political question.
According to Cohen "... advocacy is a poor substitute for dispassionate analysis [and] popular votes should not be allowed to trump scientific evidence in deciding whether or not marijuana is an appropriate pharmaceutical agent to use in modern medical practice. ... scientific evidence devoid of political considerations should be allowed to guide future decisions regarding the status of Cannabis sativa when used for medical purposes." Cohen, Peter, Medical Marijuana: The conflict Between Scientific Evidence and Political Ideology, Utah Law Review, p.41-42.
To make a scientific decision requires help. It enhances public trust and confidence in the legislature when it recognizes it lacks the expertise, resources and organization to make such a decision. Such decisions are first the provence of a peer review of the testimony and studies of pharmacologists, epidemiologists, and psychologists. For example, the Iowa legislature is currently faced with a similar question. Unlike NJ, however, the Iowa Pharmacy Board is engaged in hearings that will lead to a recommendation to Iowa legislature as to what, if any, use of marjiuna should be permitted. (3). The Board consists of five licensed pharmacists and two public members. Four are Democrats, two are republicans and one is an independent.(4).
Even with their expertise the Iowa Board has a Herculean task. The Iowa Pharmacy Board's actions to determine if there is any appropriate medicinal use for marijuana, including any recommendations concerning production, distribution and consumption, will quite rightly be compared (5) to the standards and process by which the U.S. Food and Drug Administration approves any drug for human use. (6) (7).
There are many criteria that must be met. Unless a state government’s expertise,resources and organization are at least equal to that of the F.D.A. it is questionable any state can reinvent the wheel (the next time you’re in a drug store look around at the over-the-counter and prescription medicines). Scientific certainty, while not absolute certainty, seems precise. Scientific testing is not a hodge podge of studies based on too few few participants or a collection of personal testimonials.
While those studies and antedotes may be relevant and may inform an F.D.A. review, the F.D.A. requires several phases of testing that generally includes the monitoring of several thousand participants. Indeed, the Iowa Globe-Gazzette's 10-07-09 report "Consensus: Medical marijuana helps pain, needs more research" (8) on yesterday's Iowa Board hearing notes an apparent consensus that while marijuana may relieve pain, more testing is necessary. The Iowa Globe's observation is important because it is exactly the same conclusion reaced by the IOM study relied on in the NJ Compassionate Use Medical Marijuana Act.(9).
It now appears the F.D.A. is close to resolving many of the outstanding issues. In 2006 GW Pharmaceuticals (gwpharm DOT com) began clinical trials of "Sativex" under the supervision & in accord with F.D.A. guidelines. Sativex meets a diverse range of criteria by delivering the cannabis product via an inhaler and thus allows a user to function "normally" because it relieves [1] the pain [2] without the "high" and [3] prevents the rapid deterioration to lung function associated with smoking marijuana. .
Clinical trials are presently in or at the end of their phase II or III level. These trials provide a clear meaning to the "scientific certainty" required for approval by measuring both its purported benefits while seeking to mitigate its potential harms. In short, the tests address the foreseeable consequences of the drugs use in order to insure its application is not only accurate, valid and reliable, but its harm is insignificant and the potential for abuse minimized. Specifically, the Sativex trials for MS, cancer and other disorders demonstrate how science must be applied to discern if there is any benefit to patients without damage from ingestion and discouraging recreational use.
In sum, the F.D.A. will soon settle the issue as to whether and under what cirumstances marijuana has any medical value.
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NOTE:
According to the previous 2008-09 GW pharmaceuticals web site:
(i) "GW intends to seek marketing approval for "Sativex" by means of the conventional FDA regulatory process. As GW moves through that process, we will naturally follow the FDA's guidance …"
(ii) "It is important to understand that the medical benefits of cannabis-based medicines are separate and distinct from the “high” associated with cannabis. Evidence from GW's clinical trials shows that the majority of patients can obtain the medical benefits of cannabis before any feeling of a "high". Patients emphasize that they seek to obtain the medical benefits and do not wish to experience intoxication. This is similar to the reports of patients who use self-administered morphine for pain control. Patients control or “titrate” the dose that they need to relieve their pain while minimizing unwanted side effects such as intoxication."
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* URL's Updated 12-01-09 2:15 P.M. EDT. If link is gone contact us or use Google.com (not google.com/news)
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