"We are not here to curse the darkness; we are here to light a candle."

Wednesday, December 2, 2009

NJMS Won't Certify, A-804 Won't Help, States' "Woefully Inadequate" Marijuana Programs, AMA's Call for Clinical Research & FDA Sativex Trials Require Tabling NJ's Compassionate Use Medial Marijuana Act

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.

---------------------------------------------------

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.

DETAIL
-------------------------------------------------------------------

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."

==========================================
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.
=========================================

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.
--------------------------------
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."
--------------------------------

* 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)

Wednesday, August 19, 2009

Iowa Pharmacy Board's Review of Marijuana as a Medicine: Possibilities & Pitfalls

Overview

The State of Iowa has authorized the Iowa Pharmacy Board (pdf) to review drug schedule classifications and hence what medical use and circumstances, if any, apply to certain controlled substances.


Today, August 19, 2009, the Iowa Pharmacy Board holds the first of four public hearings as part of a review to determine whether there is sufficient evidence to warrant the legislature's authorizing the use of marijuana for any medicinal purpose.


Members of the seven person board are appointed by the serving governor at the time of vacancy for a term of 3 years. Currently, the Board consists of five licensed pharmacists and two public members. Four are Democrats, two are republicans and one is an independent.


I. The Pharmacy Board Hearings are important because they shift the focus of decision making from the partisan special interests inherent in the political process to a more objective review of the evidence based on scientific method.


George Washington University Constitutional law Professor Turley notes the partisan political interests involved in the issue 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. 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 (pdf)." (download here) (or here).


Professor Cohen concludes:

(1) "activists on both sides are responsible for the current state of affairs..." Cohen, p. 42 (download here or here)

(2) "... 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." Cohen, p. 41

(3) ... 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, p.42 .


II. Since the Iowa Pharmacy Board's review of "medical" marijuana is of both State and National importance, facilitating public access to all written evidence and oral testimony is crucial to public trust and conficence in the Board's report to the Legislature.


The Iowa Pharmacy Board's ground braking 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 (Cohen, p. 42) to the standards and process by which the U.S. Food and Drug Administration approves the human use of any drug. (F.D.A. 1) (F.D.A. 2).


For policymakers and the public to have confidence in the Iowa Pharmacy Board's recommendations, both the recommendations and the process leading to those recommendations must be perceived to be, and actually be material, accurate, valid and reliable.


Moreover, the analysis of both Professors Turley and Cohen make it clear that no matter what the Iowa Pharmacy Board concludes those interests the Board's marijuana recommendations favor will promote the report, while those interests the Board's marijuana recommendations diminish will attack it.

Accordingly, to gain policymaker and public trust and minimize the possibility the Iowa Pharmacy Board's study is hijacked by special interests is if all concerned can review both included and excluded evidence and verify the evidentiary steps leading the Board to its ultimate conclusions.


To date the Iowa Pharmacy Board has shown an appreciated willingness to be transparent in its decision making process. Oral testimony will be transcribed and interested parties are encouraged to submit their views in writing. Most importantly the Board has informed the participants "All oral testimony and written comments received by the Board will be public information."


The concern here, however, is not with the Board's transparency but with access to that transparency. Open hearings are constrained by one's ability to attend them as well as the meeting halls ability to accommodate them. Also, the physical review or duplication of written comments is difficult, time consuming, and the cost may be prohibitive.


III. Given the widespread implications and interest in these hearings and statements however, it is hoped and the Board is asked to:

(1) make the testimony available via a pod cast on its web site or place a downloadable copy of the hearing transcripts on its web site.

(2) Place a downloadable copy of all written comments on its web site.

Friday, June 12, 2009

Justice Albin's Senate Confirmation Hearing: What's Marijuana Got to do with it?

The purpose of this post is to submit pose a question to Justice Albin appropriate to his June 22, 2009 Senate confirmation hearing.

The goal is to better understand Justice Albin's views on Constitutional and criminal law as well as legal ethics. This approach was chosen because it is informative as to Justice Albins's impartiality while divorced from any potential charges of partisan inquiry. To accomplish this goal the following detail is divided into three parts. Part one introduces the question and offers a standard for appraising Justice Albin’s answer. Part two discusses why the question is appropriate to the Senate confirmation hearing. Part three seeks to identify some of the elements that one would expect Justice Albin to consider in his answer.

I. The Question for Justice Albin.

Is a state legislator, who is also a state licensed attorney, subject to accountability for misconduct pursuant to the New Jersey Rules of Professional Conduct ("RPC") , Federal District Court Rules, Civ. Rules 101.1, 101.4 (pdf.), and or Federal Rule of Appellate Practice, FRAP 46 (pfd), for acts that facilitate, are accessory to, or actually participates in the production, distribution or consumption of marijuana for medicinal purpose? And if so, does the Court or its Agency have an independent duty to prosecute the infraction(s)?

RPC 8.4(b) reads:

"It is professional misconduct for a lawyer to commit a criminal act that reflects adversely on the lawyer’s honesty, trustworthiness or fitness as a lawyer in other respects;..."

Moreover, it appears that in New Jersey, an actual criminal conviction is not necessary to invoke disciplinary action.
"Under RPC 8.4(b), all that is required for discipline is a finding that there was a criminal act. There need not be a conviction or even an indictment for the crime in order for discipline to be imposed. See Matter of Hasbrouck, 140 N.J. 162, 166-167, (1995). Indeed, even an acquittal on criminal charges do not bar the imposition of discipline from the same allegations. Matter of Rigolosi, 107 N.J. 192, 206 (1987); In re Pennica, 36 N.J. 401, 418 (1962). Nor does it matter that the attorney was given immunity from criminal prosecution. In re Tumini, 95 N.J. 18 (1983). Nor does the attorney's admission into a pretrial intervention program bar discipline for the acts giving rise to the underlying charge. Matter of Asbell, 135 N.J. 446 (1994). See also New Jersey Court R. 1:20-13(b)(3) (providing that, although a temporary suspension will be lifted on a reversal of a conviction, disciplinary proceedings will not be terminated)."


II. Why the Question is Appropriate for the Senate Confirmation Hearing.

First, "assuring impartiality does not require that the judge pretend to lack views on important topics of constitutional law.' Proof that a Justice's mind at the time he joined the Court was a complete tabula rasa in the area of constitutional adjudication would be evidence of lack of qualification, not lack of bias.'" Chief Justice Rehnquist (pdf.). And, see: Laird v. Tatum, 409 U.S. 824 (1972).

Thus, questions concerning criminal as well as civil law are appropriate because they fall under the Constitution's domain and Justice Albin's experience raises the expectation he has a high level of proficiency in this area.

Additionally, the Supreme Court Justices are ultimately responsable for resolving ethical controversies that arise within the legal profession.

And finally, questions concerning participation in past cases, while appropriate,
provide no potential basis for muddling his responses or the lack thereof. And, as the questions are not case specific there is no danger to the future review of cases that may come before the Court.

Second, "The people's confidence is not an inalienable right bestowed upon the Court either by the Constitution or the creator. That confidence is a matter to be earned by every public official, but especially unelected life-tenured judges who are generally unaccountable to the public. Sometimes this unaccountability protects integrity. But sometimes, it invites bad behavior." Lazarus, Point 5, Paragraph 27.

Public "Deference to the judgments and rulings of courts depends upon public confidence in the integrity and independence of judges. ... Although judges should be independent, they should comply with the law ... Public confidence in the impartiality of the judiciary is maintained by the adherence of each judge to this responsibility. Conversely, violation ... diminishes public confidence in the judiciary and thereby does injury to the system of government under law. Model Code of Judicial Conduct, Canon 1 commentary.

In short, while it is important to ascertain whether Justice Ablin's view of the law reflects mainstream thought, it is less important that he agree with established law. What is important, however, is that he is informed by it, acknowledges it and, until changed, respect its. Republican Party of Minnesota v. White, 536 U.S. 765, 772 (2002).

Third, it is said "A lawyer is a representative of clients, an officer of the legal system, and a public citizen having special responsibility for the quality of justice." As a member of the Supreme Court, Justice Albin is responsible for the ethical conduct of those involved in the profession. Just as legislators are accountable to ethical constraint, lawyers are also subject to ethical constraint.

Thus, Justice Albin's views on ethical rules, such as misconduct that rises to the level of professional misconduct and hence Supreme Court sanction, are also appropriate to the public's confidence and trust in the integrity of the judicial institution.

III. Elements One Would Expect Justice Albin to Consider in His Answer About Malpractice.

PREMISE I: Since the Congress makes the law, the Executive enforces the law (as opposed to a case) and the judiciary is the arbitrator of disputes arising under the law, State "medical marijuana" laws appear to thumb their nose at the Constitution, the Congress and the Supreme Court. Moreover, such enactments create a constitutioanl crisis between the nations and state governments and between the Executive branch and Congressional and Judicial branches. Accordingly, as every state judge and justice has a duty to make the Constitution the supreme law it seems appropriate to ask Justice Albin his views on the law as it stands concerning "medical marijuana."

PREMISE II: THE CONTROLLED SUBSTANCES ACT ("CSA") IS THE "LAW OF THE LAND."

The main oblectives of Title II of the Comprehensive Drug Abuse Prevention and Control Act., the CSA, are to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances. GONZALES v. RAICH, 545 U. S. 1, 12 (2005)[pfd] ... Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels. Vol. 545 U. S. 12-13 ... To effectuate these goals, Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA. 21 U. S. C. §§ 841(a)(1), 844(a). The CSA categorizes all controlled substances into five schedules. § 812. The drugs are grouped together based on their accepted medical uses, the potential for abuse, and their psychological and physical effects on the body. §§ 811, 812. ... The CSA and its implementing regulations set forth strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping. Ibid.; 21 CFR § 1301 et seq. (2004). Vol. 545 U. S. 13.

PREMISE III: INVOLVEMENT IN OR FACILITATING THE PRODUCTION, DISTRIBUTION OR CONSUMPTION OF MARIJUANA FOR ANY PURPOSE, INCLUDING MEDICAL USE, IS A FEDERAL CRIME.

In enacting the CSA, Congress classified marijuana as a Schedule I drug. 21 U. S. C. § 812(c). ... Schedule I drugs are categorized as such because of their high potential for abuse, lack of any accepted medical use, and absence of any accepted safety for use in medically supervised treatment. § 812(b)(1). ... By classifying marijuana as a Schedule I drug, as opposed to listing it on a lesser schedule, the manufacture, distribution, or possession of marijuana became a criminal offense, with the sole exception being use of the drug as part of a Food and Drug Administration preapproved research study. §§ 823 (f), 841(a)(1), 844(a); see also United States v. Oakland Cannabis Buyers’ Cooperative, 532 U. S. 483, 490 (2001). Vol. 545 U. S. 14.

PREMISE IV: THE SUPREMACY CLAUSE DEPRIEVES EVERY STATE GOVERNMENT OF ANY POWER FROM WHICH TO AUTHORIZE ITS MEDICAL USE.


The question before [THE COURT] is not whether it is wise to enforce the statute in these circumstances; rather, it is whether Congress’ power to regulate interstate markets for medicinal substances encompasses the portions of those markets that are supplied with drugs produced and consumed locally. Vol. 545 U. S. 9. The notion that California law has surgically excised a discrete activity that is hermetically sealed off from the larger interstate marijuana market is a dubious proposition, and, more importantly, one that Congress could have rationally rejected. Vol. 545 U. S. 30.


The fact that marijuana is used “for personal medical purposes on the advice of a physician” cannot itself serve as a distinguishing factor. Id., at 1229. The CSA designates marijuana as contraband for any purpose; in fact, by characterizing marijuana as a Schedule I drug, Congress expressly found that the drug has no acceptable medical uses. Vol. 545 U. S. 27.



When [Congress] enacted comprehensive legislation to regulate the interstate market in a fungible commodity, Congress was acting well within its authority to “make all Laws which shall be necessary and proper” to “regulate Commerce . . . among the several States.” U.S. Const., Art. I, § 8. That the regulation ensnares some purely intrastate activity is of no moment. Vol. 545 U. S. 22. When Congress decides that the “‘total incidence’ ” of a practice poses a threat to a national market, it may regulate the entire class. See Perez, 402 U. S., at 154– 155 (“ ‘[W]hen it is necessary in order to prevent an evil to make the law embrace more than the precise thing to be prevented it may do so’ ” (quoting Westfall v. United States, 274 U. S. 256, 259 (1927))). In this vein, we have reiterated that when “ ‘a general regulatory statute bears a substantial relation to commerce, the de minimis character of individual instances arising under that statute is of no consequence.’ ” E. g., Lopez, 514 U. S., at 558 (quoting Maryland v. Wirtz, 392 U. S. 183, 196, n. 27 (1968); emphasis deleted). Vol. 545 U. S. 17.

Wednesday, June 3, 2009

New Jersey Compassionate Use Medical Marijuana Act (S-119 & A-804) (Updated 06-07-09)

SUMMARY:

1. The central problem with enacting the "New Jersey Compassionate Use Medical Marijuana Act" (S-119, A-804) is not marijuana. It is the deliberate indifference exhibited by New Jersey Government – the Acts promoting State legislators and Governor Corzine - to the adverse consequences of their conduct on our basic democratic government and the rights of others. Furthermore, any participation resulting in its enactment appears to be not only unlawful but criminal. Even New Jersey's AG Milgram seems susceptible as she has given the state's behavior an unsubstantiated and unknowable thumbs up sound bite. In sum, certain New Jersey politicians appear to be creating a narco-state by substituting their own arbitrary governance for the rule of law.


2. The New Jersey Compassionate Use Medical Marijuana Act also seems to be posing problems for President Obama. Congress makes the law and the President executes the law. In line with his Executive power, the April 11, 2009 California’s Valeo Times-Herald noted President Barack Obama campaigned on a platform of "change" as it pertains to the way Washington governs U.S. marijuana policy. However, the paper also reports U.S. Attorney General Eric Holder reaffirmed, in opposition to his duty to enforce the law, that he will not authorize federal justice resources to target or prosecute medical cannabis users or providers that are compliant with state law. Holder's statements clarified earlier remarks he made when he said that the Justice Department would uphold President Obama's campaign pledge not to use the power of the federal government to circumvent state medical marijuana laws.

Since then, however, President Obama seems to have realized he was violating the separation of powers doctrine because, through the Department of Justice, he signaled he will not restrain federal prosecutors targeting medical marijuana providers. Any lingering hopes that the new Administration would implement change in this area were blasted April 17 when U.S. Attorney Thomas O'Brien forwarded to District Judge George Wu a letter from DOJ clarifying Obama Administration policy.


3. JUNE 07, 2009 UPDATE:

AG HOLDER THUMBS HIS NOSE AT CONSTITUTION, CONGRESS ,AND THE SUPREME COURT

GWU Constitutional law professor Turley has had it right from the beginning.

Those who seek to capitalize on Holder's mendacity would do well to remember that those who profit from it today may be the victim of it tomorrow.

On Friday, June 6, 2009, News 4 New Mexico (text & Video), noting "medical marijuana is illegal under Federal law," asked AG Holder, about federal raids on local growers. Holder answered:

1. The focus of the Administration is on traditional forms of large drug trafficking and those sanctioned and acting consistent with state law and given limited Federal resources "will not be an emphasis for this administration"
Holder's words are duplicitous. His statement enforcement "will not be an emphasis" demonstrates his knowledge that he lacks Constructional authority to refuse to effect the will of Congress concerning a class of case, but uses the word "emphasis" as a wink and a nod to communicate he will do what he can to ignore both Congress and the U.S. Supreme Court. In effect he is both a usurper and possibly a criminal conspirator.

2. Asked if he supports federal legislation legalizing "medical" marijuana Holder said "that is something for the states to decide."

The second statement is frivolous and lacks any foundation since the U.S. Supreme Court has twice ruled on the issue. AG Holder’s hypocrisy and perhaps cowardice is plain as AG Holder must also know the Congress has provided him with the power to remove Marijuana from its Schedule I prohibition for medical use.

The views expressed herein remain unchanged.

Unfortunately, as states continue to attempt to implement medical marijuana laws the erosion of the Supremacy Clause and the doctrine of Federalism continues to take place.

The irony is this. If after over a 150 years of struggle these states are allowed to succeed, incorporation of the Bill of Rights, everything from free speech, the right to bear arms to Due Process and “Jim Crow” are again at issue.

Disagree? Take your best shot because silence is consent.

Before responding, however, you might want to look at the reasoning below:

I. INVOLVEMENT IN OR FACILITATING THE PRODUCTION, DISTRIBUTION OR CONSUMPTION OF MARIJUANA FOR ANY PURPOSE, INCLUDING MEDICAL USE, IS A FEDERAL CRIME.

II. ANY NEW JERSEY LEGISLATION IS INVALID AS STATE GOVERNMENTS HAVE NO LEGITIMATE POWER FROM WHICH TO AUTHORIZE OR REGULATE MARIJUANA USE.

III. NEW JERSEY LACKS BOTH THE AUTHORITY AND COMPETENCE TO DETERMINE WHETHER MEDICAL MARIJUANA IS EITHER A "LEGAL" MEDICINE OR A "SAFE" MEDICINE.

BACKGROUND: THE CONTROLLED SUBSTANCES ACT ("CSA")

The main objectives of Title II of the Comprehensive Drug Abuse Prevention and Control Act., the CSA, are to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances. Gonzales v. Raich, 545 U. S. 1, 12 (2005) [pdf. volume] . ... Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels. Vol. 545 U. S. 12-13 ... To effectuate these goals, Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA. 21 U. S. C. §§ 841(a) (1), 844(a). The CSA categorizes all controlled substances into five schedules. § 812. The drugs are grouped together based on their accepted medical uses, the potential for abuse, and their psychological and physical effects on the body. §§ 811, 812. the CSA and its implementing regulations set forth strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping. Ibid.; 21 CFR § 1301 et seq. (2004). Vol. 545 U. S. 13.


I. INVOLVEMENT IN OR FACILITATING THE PRODUCTION, DISTRIBUTION OR CONSUMPTION OF MARIJUANA FOR ANY PURPOSE, INCLUDING MEDICAL USE, IS A FEDERAL CRIME.


FACT: In enacting the CSA, Congress classified marijuana as a Schedule I drug. 21 U. S. C. § 812(c). ... Schedule I drugs are categorized as such because of their high potential for abuse, lack of any accepted medical use, and absence of any accepted safety for use in medically supervised treatment. § 812(b) (1). . ... By classifying marijuana as a Schedule I drug, as opposed to listing it on a lesser schedule, the manufacture, distribution, or possession of marijuana became a criminal offense, with the sole exception being use of the drug as part of a Food and Drug Administration preapproved research study. §§823(f), 841(a) (1), 844(a); see also United States v. Oakland Cannabis Buyers’ Cooperative, 532 U. S. 483, 490 (2001) (pdf). Vol. 545 U. S. 14.


FICTION: "States are not required to enforce federal law or prosecute people for engaging in activities prohibited by federal law; therefore, compliance with this act does not put the State of New Jersey in violation of federal law." S-119 (2) (d).


The above statement is a fatally flawed combination of half-truth, false Analogy and faulty cause and effect. The first part of the statement that "States are not required to enforce federal law or prosecute people for engaging in activities prohibited by federal law" may only be partially accurate. For instance, state judges are required to enforce the U.S. constitution. In terms of "medical" marijuana:





"[T]he state does not punish a violation of the federal law 'as such,' it can only reach conduct subject to the federal criminal law by incorporating the conduct into the state law." ... "we think judicial enforcement of federal drug policy is precluded in this case because the act in question -- possession of medical marijuana -- does not constitute an offense against the laws of both the state and the federal government. Because the act is strictly a federal offense, the state has "no power to punish." Garden Grove v. Superior Court, pg. 24,26 (pdf file).


It is both a false analogy and faulty cause and effect to say that (1) since NJ lacks the authority to enforce a solely federal law or prosecute the violators of that law it follows that "compliance with this act does not put the State of New Jersey in violation of federal law." Assuming New Jersey has no authority to enforce and prosecute a purely federal law means just that. While A-804's enactment may not violate State law, it does not follow the government of NJ and its state actors have no federally imposed obligation to comply with federal law and are thus free to violate federal law. To the contrary. Because A-804 facilitates the criminal use of, or participating in the actual use of marijuana its enactment transforms New Jersey into a narco-state. New Jersey is a narco-state by definition because (1) by creating an exclusive mechanism for the production, distribution and consumption of marijuana in violation of federal law, NJ is no different than any other drug cartel, and (2) by removing medical marijuana from the State Criminal Code it significantly reduces the presence of law enforcement. Finally,




"It is quite clear California has chosen a policy that is at odds with the federal government's. … As a general rule, it is still illegal to possess marijuana under federal law, and nothing in this opinion should be construed as suggesting otherwise. Garden Grove v. Superior Court, pg. 34 (pdf file).



II. ANY NEW JERSEY LEGISLATION IS INVALID AS STATE GOVERNMENTS HAVE NO LEGITIMATE POWER FROM WHICH TO AUTHORIZE OR REGULATE MARIJUANA USE.


The question before [THE COURT] is not whether it is wise to enforce the statute in these circumstances; rather, it is whether Congress’ power to regulate interstate markets for medicinal substances encompasses the portions of those markets that are supplied with drugs produced and consumed locally. Vol. 545 U. S. 9. The notion that California law has surgically excised a discrete activity that is hermetically sealed off from the larger interstate marijuana market is a dubious proposition, and, more importantly, one that Congress could have rationally rejected. Vol. 545 U. S. 30.


The fact that marijuana is used “for personal medical purposes on the advice of a physician” cannot itself serve as a distinguishing factor. … The CSA designates marijuana as contraband for any purpose; in fact, by characterizing marijuana as a Schedule I drug, Congress expressly found that the drug has no acceptable medical uses. Vol. 545 U. S. 27. When [Congress] enacted comprehensive legislation to regulate the interstate market in a fungible commodity, Congress was acting well within its authority to “make all Laws which shall be necessary and proper” to “regulate Commerce . . . among the several States.” U. S. Const., Art. I, § 8. That the regulation ensnares some purely intrastate activity is of no moment. Vol. 545 U. S. 22.


When Congress decides that the “‘total incidence’ ” of a practice poses a threat to a national market, it may regulate the entire class. See Perez, 402 U. S., at 154– 155 (“ ‘[W]hen it is necessary in order to prevent an evil to make the law embrace more than the precise thing to be prevented it may do so’ ” (quoting Westfall v. United States, 274 U. S. 256, 259 (1927))). In this vein, we have reiterated that when “ ‘a general regulatory statute bears a substantial relation to commerce, the de minimis character of individual instances arising under that statute is of no consequence.’ ” E. g., Lopez, 514 U. S., at 558 (quoting Maryland v. Wirtz, 392 U. S. 183, 196, n. 27 (1968); emphasis deleted). Vol. 545 U. S. 17.


III. NEW JERSEY LACKS BOTH THE AUTHORITY AND COMPETENCE TO DETERMINE WHETHER MEDICAL MARIJUANA IS EITHER A "LEGAL" MEDICINE OR A "SAFE" MEDICINE.


The CSA provides for the periodic updating of schedules and delegates authority to the Attorney General, after consultation with the Secretary of Health and Human Services, to add, remove, or transfer substances to, from, or between schedules. § 811. Vol. 545 U. S. 14-15.


CSA is a comprehensive regulatory regime specifically designed to regulate which controlled substances can be utilized for medicinal purposes, and in what manner. Indeed, most of the substances classified in the CSA “have a useful and legitimate medical purpose.” 21 U. S. C. § 801(1). Vol. 545 U. S. 27. Thus, even if respondents are correct that marijuana does have accepted medical uses and thus should be redesignated as a lesser schedule drug, the CSA would still impose controls beyond what is required by California law. The CSA requires manufacturers, physicians, pharmacies, and other handlers of controlled substances to comply with statutory and regulatory provisions mandating
registration with the DEA, compliance with specific production quotas, security controls to guard against diversion, recordkeeping and reporting obligations, and prescription requirements. Vol. 545 U.S. 27. §§ 821–830; 21 CFR § 1301 et seq. (2004). Furthermore, the dispensing of new drugs, even when doctors approve their use, must await federal approval. United States v. Rutherford, 442 U. S. 544 (1979). Accordingly, the mere fact that marijuana—like virtually every other controlled substance regulated by the CSA—is used for medicinal purposes cannot possibly serve to distinguish it from the core activities regulated by the CSA. Vol. 545 U. S. 28.


The irony of the above is that both S-119 and A-804 recognize New Jersey is not equipped to make a decision as to whether "medical" marijuana is a
"legal" medicine or a "safe" medicine. Read the small print. Read the last paragraph of both S-119 and A-804:



The bill states that nothing in it should be construed to require a government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana, or an employer to accommodate the medical use of marijuana in any workplace. Finally, the bill provides that the State would not be held liable for any deleterious outcomes from the medical use of marijuana by any qualifying patient.

Yet A-804 claims "Modern medical research has discovered a beneficial use for marijuana in treating or alleviating the pain or other symptoms associated with certain debilitating medical conditions, as found by the National Academy of Sciences' Institute of Medicine in March 1999;" A-804 (2)(a).


Such reliance is misplaced, however, as the 1999 Institute of Medicine (IOM) report is not a general reference and not clearly pro or con. (A pdf of the report is available by clicking "Marijuana and Medicine: Assessing the Science Base.")


The following demonstrates the Bill's reliance of this report is exaggerated because the report (1) recognizes the need for further extensive testing for which the legislation makes no provision, (2) requires, as a precondition for limited use, a strict monitoring mechanism, for which the legislature makes no provision, and (3) while the report addresses the negative effects, the Bill is
a half-truth
as it tells only half of the story by neglecting the negative aspects.


And, because it ignores the negative aspects it makes no provision for adequately addressing them. In sum the IOM report substantiates both the Congress and Supreme Court determination the F.D.A.'s singular role in both approval any production of and regulation of any distribution of medical
marijuana.


The report concludes:

[1] At this point, our knowledge about the biology of marijuana and cannabinoids allows us to make some general conclusions:

a. Cannabinoids likely have a natural role in pain modulation, control ofmovement, and memory.


b. The natural role of cannabinoids in immune systems is likely multi-facetedand remains unclear.


c. The brain develops tolerance to cannabinoids.


d. Animal research demonstrates the potential for dependence, but thispotential is observed under a narrower range of conditions than withbenzodiazepines, opiates, cocaine, or nicotine.


e. Withdrawal symptoms can be observed in animals but appear to be mildcompared to opiates or benzodiazepines, such as diazepam (Valium).


[2]: The different cannabinoid receptor types found in the body appear to play different roles in normal human physiology. In addition, some effects of cannabinoids appear to be independent of those receptors. The variety of mechanisms through which cannabinoids can influence human physiology
underlies the variety of potential therapeutic uses for drugs that might act selectively on different cannabinoid systems.


It recommends:


1: Research should continue into the physiological effects of synthetic and plant-derived cannabinoids and the natural function of cannabinoids found in the body. Because different cannabinoids appear to have different effects, cannabinoid research should include, but not be restricted to, effects attributable to THC alone. p 3-4.


2: Clinical trials of cannabinoid drugs for symptom management should be conducted with the goal of developing rapid-onset, reliable, and safe delivery systems. p.4

3: Psychological effects of cannabinoids such as anxiety reduction and sedation, which can influence medical benefits, should be evaluated in clinical trials. p.5


4: Studies to define the individual health risks of smoking marijuana should be conducted, particularly among populations in which marijuana use is prevalent. p.6


5: Clinical trials of marijuana use for medical purposes should be conducted under the following limited circumstances: trials should involve only short-term marijuana use (less than six months), should be conducted in patients with conditions for which there is reasonable expectation of efficacy, should be approved by institutional review boards, and should collect data about efficacy.
p.7


6: Short-term use of smoked marijuana (less than six months) for patients with debilitating symptoms (such as intractable pain or vomiting) must meet the following conditions:


a. failure of all approved medications to provide relief has been documented,


b. the symptoms can reasonably be expected to be relieved by rapid onset cannabinoid drugs,


c. such treatment is administered under medical supervision in a manner that allows for assessment of treatment effectiveness, and

d. involves an oversight strategy comparable to an institutional review board process that could provide guidance within 24 hours of a submission by a physician to provide marijuana to a patient for a specified use. p. 7-8


For further comparisons see "What did the 1999 Institute of Medicine (IOM) Report Says."

Saturday, February 14, 2009

Why the N.J. Supreme Court Should Review the Corzine-Katz Email Appeal

The N.J. GOP’s Tom Wilson has appealed to the N.J. Supreme Court to review the appellate panel’s decision to overturn the trial court decision and deny public access to the Governor Corzine and then C.W.A. local president Katz emails. The emails argue about the inclusion of certain features in a new union contract.

This case embodies the most important issue the Court has been asked to decide. If you think N.J.’s politicians ignore you now – wait – it can get worse. Here’s why.

Review will either reaffirm or destroy the inherent superior authority, function and need of the people to define and demand“good behavior” from those they elect. When all is said and done, either the people will retain the constitutional power to make politicians serve the public or the politicians will confiscate the people’s most basic safeguard, i.e. the right to know, against politicians serving themselves.

The Founding Fathers recognize early on the structure of the new government had to possess the capability to govern while the people had to have the power to make sure those elected govern in a manner that both appears to and in fact does act on their
behalf.


"If angels were to govern men, neither external nor internal controls on government would be necessary. In framing a government which is to be administered by men over men, the great difficulty lies in this: you must first enable the government to control the governed; and in the next place oblige it to control itself. A dependence on the people is, no doubt, the primary control on the government; but experience has taught mankind the necessity of auxiliary precautions.” Madison, Federalist Paper # 51, par. 3.

The Founder's also recognize knowlege that comes from the right to know is the key to the public's exercise" of its primary function to control thegovernment.
"Enlightened choice by an informed citizenry is the basic ideal upon which an open society is premised ... [a] popularGovernment without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps both. ... (Quoting Letter from James Madison to W.T. Barry (Aug. 4, 1822), in 9 Writings of James Madison 103 (G. Hunt ed. 1910)).” Atlantic City Convention Center Authority v. South Jersey Publishing Company, (A-52-93), pg.5-6.


Executive privilege also reflects the belief that effective decision making is facilitated by an environment that is favorable to a frank and thorough examination of the matter at hand. It is assumed, however,that confidentiality encourages a robust dialogue while openness may inhibit candor. Within this context, Governor Corzine claims the Office of Governor, as Chief Executive of the State, has a general right to confidentiality in decision making that it interprets is equivalent to the United States President’s right (But See, Raoul Berger, "Executive Privilege: A Constitutional Myth").

Tom Wilson, however, doesn’t appear to dispute the general need, right, or function of the Governor to use Executive Privilege to best execute the duties of the office. What he does appear to be saying, however, is that the Governor needs to respect and therefore the Court balance his right with the “primary” need, right and function of the people to insist the Governor acts in a manner that, in both appearance and fact, is consistent with the majority of the people’s definition of good behavior. N.J. Supreme Docket # 63,765.

An example away from Wilson, is that while national security may protect the government from the disclosure of information that would reveal military secrets, it has no right to confidentiality when the claim to secrecy represented to a court by its lawyers is a lie. Neither Corzine nor Wilson dispute the public’s right to throw Corzine out of office when they disapprove of the Governor’s conduct. And, at least since the Nixon administration, there appears to be a general agreement that confidential discussions and information are, subject to case by case specifics, accessible to the public in criminal matters.

Where Corzine and Wilson disagree is Corzine believes the public has no independent right to know. Thus, according to the appellate court opinion, it is only in those instances when government prosecutors - who are either appointed by the President, i.e. Chris Christie, or are appointed by the Governor, i.e. Ann Milgram - exercise their freedom of choice to prosecute a criminal case will the public ever have some uncertain right to know. In essence, the Appellate Court ruling extinguishes the fundamental need, right, and function of public to make informed, independent decisions to most effectively address any Governor’s lack of good behavior.

Historically, Executive Priviledge is negated when the integrity of the government’s decision making process has been successfully put at issue. Escaping the Fishbowl, pgs. 1772, 1787.

There may be blindness, but there is no doubt. The appellate court's tortured distinction between those who 'negotiate" and those who "advocate", is a distinction without a difference. Governor Corzine diminished the public's respect and confidence in the integrity of his Office when, because of his personal relationship with Ms. Katz, he acted with deliberate bad faith toward the public and the union. Anyone who deals with the Governor will easily conclude the appellate court has given the Governor a license to pursue similar antics in his dealings with them. To that end the Court has long recognized when it comes to the Office of the Governor the "overwhelming importance of having able, honest and honorable persons ... is self-evident." Nero v. Hyland, 216 N.J. 216, 224 (1978). The Supreme Court should not let such a precedient pass in silence.