Tuesday, December 20, 2011

Marijuana: Drug or Herb? (Part II)

Marijuana: Drug or Herb? (Part II)



While I was writing “Marijuana: Drug or Herb?” (posted 12/11/11), a small idea started nibbling at the far corners of my mind.  That nibbling has grown into a constant gnawing, so with a large measure of diffidence, I am sharing that idea with you.  I warn you that this idea goes far beyond my areas of competence, but my hope is that someone with greater knowledge than mine (a very low standard) of the production, distribution, and prescription regulations of the Drug Abuse Control and Prevention Act, FDA practice, and regulation of dietary Supplements will either shoot it down completely or flesh it out into a viable theory.

Rescheduling marijuana out of the totally prohibited drugs of Schedule I has been a major effort of drug law reformers for more than forty years – longer than the professional lives of most of those concerned.  In the last few years many of those reformers have become concerned about what will happen if marijuana is rescheduled.  The consensus has been that, if it is to be legally distributed, marijuana will have to pursue a New Drug Application through the FDA – an arduous and costly procedure.  But is that consensus necessarily correct?  Answering this question requires looking at the total federal scheme for regulating drugs.

Speaking broadly (and ignoring literally dozens of amendments), federal drug regulation rests on four statutes: the Food, Drug and Cosmetics Act (FDCA), the Drug Abuse Control and Prevention Act, Part I (DACP), the Controlled Substances Act (CSA, which is Part II of the DACP), and the Dietary Supplement Health and Education Act (DSHE).  These acts were passed over a sixty-year period and contain many overlaps while allowing gaps to remain in their coverage.

The FDCA controls the marketing of all drugs affecting interstate commerce.  Any drug without an FDA approved label will be presumed misbranded, and therefore its sale would be deceptive and misleading.  That label must include information about at least one medical use for which the drug has been proved, to the satisfaction of the FDA, to be both effective and safe.  Because it is constitutionally barred from regulating the practice of medicine, the FDA cannot require doctors to use those drugs for their proven uses nor can it bar doctors from prescribing those drugs for other, non-labeled uses.  This latter practice of off-label prescribing is wide-spread.  Hair restoration was originally an off-label use of Rogaine.

Two exemptions to FDA jurisdiction are recognized.  The Supreme Court has held that Congress intentionally exempted alcohol and tobacco (two truly dangerous drugs) from regulation by the FDA (and by implication, from the DEA).  The DSHE conditionally exempts dietary supplements, including herbs, from FDA regulation.  The FDA only retains what may be called “watching jurisdiction”.  If sufficient evidence exists that the supplement is misbranded or marketed in a deceptive or misleading fashion (normally by making health claims), the FDA may remove the product from the market until the distributor has obtained an NDA.

The DEA has the authority under the CSA to find that a drug has a potential for abuse.  If it so finds, the DEA may bar its manufacture, distribution, or possession (by placing the drug in Schedule I) or regulate the method by which it is distributed (by placing it in Schedules II – V).

Once a drug is in Schedules II –V, the DACP controls the way in which the DEA (originally the BNDD) regulates the manufacture, inventory, and distribution of that drug.  If the FDA has ruled the drug to be available only on prescription, the DEA also regulates the manner in which that prescription is processed and filled.  Neither the FDA nor the DEA may require or forbid a doctor to employ a drug other than those in Schedule I; and only the FDA – not the DEA – may determine that a prescription is required for the dispensing of a drug.  But the DSHE exempts dietary supplements, including herbs, from pre-sale FDA jurisdiction.  The FDA can intervene in the distribution of supplements only if the distributor has violated the statutory restrictions imposed by that act.

What if marijuana were rescheduled – either by agency action or by court order (see “The Cornerstone of American Drug Policy”, posted 12/1/11)?  The most logical placement of marijuana would be in Sched. V, but placement in Sched. II, in the uncomfortable company of morphine, fentanyl, methadone, cocaine, amphetamine, methamphetamine, and Ritalin, is more likely.

As a scheduled controlled substance, marijuana producers and distributors would be subject to more (if Sched. II) or less (if Sched. V) stringent requirements for security, storage, inventory, transportation, and reporting.  But purchasers and end-users would only have to deal with state requirements.  In the sixteen jurisdictions with medical marijuana laws, those meeting the medical needs requirements could purchase freely without the necessity of a prescription.  No prescription could be required (unless imposed by state law) because the DEA is without power to require prescriptions (it can only regulate the methods by which prescriptions are handled) and the FDA would have to recognize that, marijuana being an herb, it could only act after distributors violated the limits imposed by the DSHE.  No NDA or proof of efficacy and safety could be required.

So far, all that has been demonstrated is that I still possess the Law Professor’s uncanny ability to construct complex and implausible hypothetical cases with which to confuse – and possibly enlighten – the class.  Now it’s your turn.  Can the real lawyers out there either point out the fatal flaws in the hypothetical or build it into a useable theory?  Let’s see what you can do!

   

Sunday, December 11, 2011

Marijuana: Drug or Herb?

Marijuana: Drug or Herb?



The main focus of the drug law reform movement for over forty years has been to force the DEA to move marijuana from Schedule I, making unlawful any production, distribution, or possession, to one of the less stringent schedules (II-V), in which it could be made available for medical use.  However, many have lately realized that merely rescheduling marijuana would not make it available to patients in need; its sale or distribution would still be totally blocked by lack of FDA approval for movement in commerce as a drug.

Students of classical logic or rhetoric will recognize this situation as placing marijuana on the horns of a dilemma.  One of those horns impales marijuana on DEA prohibition, while the other gores it with the lack of FDA approval.  In either case, the medical use of marijuana is impossible.

But that same student knows that the resolution of a dilemma is to go between the horns – to find a third solution, avoiding the bad outcomes threatened by the two choices presented.  Congress has already set up a third solution that would allow marijuana to avoid both DEA prohibition and FDA regulation.  Congress should recognize that, according to its own regulatory scheme, marijuana is not a drug: it is an herb.

Federal law provides three systems for regulating physiologically active substances.  The most comprehensive is the regulation of the marketing of drugs in or affecting interstate commerce by the FDA.  The sale of any drug not bearing an approved FDA label is deceptive and misleading, and therefore forbidden.

Those drugs with some potential for abuse (not defined in the statute) are regulated by the CSA.  Those with no medical use (Schedule I drugs) may not be lawfully produced, sold, or possessed.  Drugs in the less restricted schedules (II-V) have some demonstrated medical use and may be sold, but only under the regulation of both DEA and FDA.  The many drugs legally sold under dual regulation by DEA and FDA include morphine, OxyCotin, cocaine, methamphetamine, and Ritalin.

However, not all products meeting the definition of drugs under the CSA and FDCA (briefly, a substance ingested for the purpose of affecting bodily or mental function) are subject to these two agencies.  In 1996 congress enacted the Dietary Supplement Health and Education Act.  That act allowed the marketing of dietary supplements, herbal preparations, and vitamins without FDA prior approval so long as no health claims were made on the packaging or in the advertising of the product.  The preparations covered by this act include St. John’s wort and kavakava, both taken for their supposed psychoactive effects.  These effects should otherwise bring them under the CSA and DEA control.

(Congress has apparently created a fourth category of drug regulation as well.  In ruling against the FDA’s proposed attempt to regulate cigarette marketing, the Supreme Court held that the failure of congress to expressly include tobacco and alcohol in either the FDCA or the CSA established a clear congressional intent not to regulate these drugs.  This fourth category containing of drugs that are not regulated consists of two of the most dangerous and addicting substances people have ever ingested.)

The question then becomes whether marijuana is a drug, a controlled substance, or a dietary supplement.  Of those three categories, marijuana (and possibly psilocybin mushrooms and mescaline cacti) seems to best fit as a dietary supplement.  Supplements are statutorily defined  as:

`(gg) The term `dietary supplement' means a food for special dietary use, as defined in section 411(c)(3), that--

`(1) includes--

`(A) a vitamin;

`(B) a mineral;

`(C) an herb;

`(D) an amino acid;

`(E) another ingredient for use by man to supplement the diet by increasing the total dietary intake; or

`(F) a concentrate or extract of any ingredient described in clause (A), (B), (C), (D), or (E); and

`(2)(A) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

`(B) complies with section 411(c)(1)(B)(ii).'.21 U.S.C. 411.

These naturally occurring substances are significantly different from the single-molecule drugs normally covered by the stricter FDCA and CSA.  Congress, in the Dietary Supplement Health and Education Act has already provided a model of this kind of restructuring:

(b) EXCLUSION FROM DEFINITION OF DRUG- Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement or an ingredient described in clause (A), (B), (C), (D), (E), or (F) of paragraph (gg)(1) in, or intended for use in, a dietary supplement.'.

That section could be amended to read: “…Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) and Drug Abuse Control and Prevention Act of 1970[1] are amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement, including any plant or parts of plants of the genus Cannabis,…”

This reform might be more feasible than either decriminalization or legalization.  A member of congress would be merely streamlining regulation to make it more reasonable.  He would not have to face voters in defending his “soft on crime” vote to legalize dope and free hordes of fiends on the highways and around the school yards.

Marijuana is only an herb like St. John’s wort and kava, not a drug like heroin or methamphetamine.  It is time to treat it like one.  Please pass the cannabis brownies.







[1] Which included the Controlled Substances Act as Part II

Thursday, December 1, 2011

The Cornerstone of American Drug Policy

The Cornerstone of American Drug Policy

The cornerstone of American drug policy is the Controlled Substances Act of 1970, and the cornerstone of that act is the scheduling scheme.  That act divides controlled substances into five categories, or schedules.  Drugs in Schedule I, which include marijuana, heroin, LSD, peyote, and MDMA among others, may not be manufactured, distributed, or possessed by anyone. The definition of Schedule I drugs is therefore the cornerstone of the scheduling process.



To be classified in Schedule I, a drug must have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and cannot be used safely under medical supervision.  None of these three primitives are defined in the act and have not been clarified by the courts.  But the problematic element is the second.  What is “currently accepted medical use in treatment in the United States”?



Two meanings of this phrase are possible.  The first is to treat the language as requiring the DEA to look into the actual medical efficacy of the drug as shown by medical science.  This meaning has been followed by the Drug Enforcement Agency in proceedings to reschedule marijuana and MDMA since 1972. The courts have never examined this definition, all but one of the appeals on marijuana having been decided on procedural grounds.  Even in original NORML case, the court never reached the substantive issues.

The second possible meaning is that the issue is strictly one of demographics.  Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients.  In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.



An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law.  That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.



That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice.  The government began prosecuting doctors who furnished morphine or heroin   for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.



The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”.  In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA.  However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient.  So far the DEA has not presented the issue to another circuit.



Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the1930s.  The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.



Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner.  A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.



That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved.  The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses.  Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA.  The most recent case, Gonzales v. Oregon (2005), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.



A determination of "efficacy" seems very close to determining medical utility - since efficacy seems to imply "effective in treating a disease" "relieving symptoms" "boosting health functions" etc. What is the difference?

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug.  The statutory language itself reinforces this interpretation.  The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations.  Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases.  In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”.  The Court of Appeals (Grinspoon, First Circuit,1987)  rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument.  Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs.  But for that classification, their medical use would probably be common today.  Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems.  This information would be probative in a rescheduling action.  If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.



Since the passage of the CSA medical use of marijuana has blossomed even while forbidden.  Thousands of refereed medical papers have been published,  its effectiveness. Sixteen jurisdictions have enacted medical marijuana laws, and well over a million patients now regularly use medical marijuana under those laws.  The undercover illegal use by patients in other states could easily double that total.



Marijuana has now met the statutory requirements that necessitate its removal from the absolute prohibition of Schedule I.  It has been shown to be qualified as a drug available for a doctor’s prescription just like OxyCotin, cocaine, and methamphetamine. All that is necessary is for the DEA to apply the law as written.


Saturday, September 18, 2010

Gun Prohibition Won't Work either

Gun Prohibition Won’t Work Either




Violence in the Mexican drug war is soaring to unprecedented highs. Latest estimates claim that at least half of the guns used in that conflict were purchased in Texas and smuggled into Mexico, which has outlawed personal ownership of firearms. The United States government has announced that it will step up its efforts to interdict those weapons at the border and prevent their movement into Mexico.

However, this gun prohibition will not work. It suffers from the same flaws that prevented prohibitions against alcohol, drugs, gambling, prostitution, or even against counterfeit Gucci bags or pirated movies from working. The harder interdiction is imposed, the higher the price for the contraband soars, and the more ruthless the dealers attracted to the trade become. The result is not suppression of the prohibited trade; it just becomes more expensive, corrupt, and violent.

The only effective means to suppress or moderate a functioning market are those that operate on the demand side of that market. The market for tobacco provides a good example. The number of tobacco users has decreased by about 60 per cent (from over half of the adult population to about twenty per cent) through the use of three techniques: research into the psychology and physiology of tobacco use, education of users and potential users, and limitations on advertising.

While those tools against tobacco use have taken about fifty years to work, in Mexico, the United States has a much stronger tool than any of these to use against the demand for guns. The United States government has total control over the more than $30 Billion that, each year, is spent by American users and fuels the Mexican drug wars. That sum is a conservative estimate of the amount that the U.S. drug laws pump into the Mexican economy annually: an amount that is one of the top four sources of foreign money in the Mexican economy.

This money generated by the American drug laws has two effects on the demand for guns in Mexico. The most important is that control of that money is what the cartels are fighting over and what allows them to fend off the Mexican government. The second is that the money is necessary for the purchase of the guns themselves.

While Mexican society has always had a machismo strain of violence dating back to at least the time of the Spanish conquest, the current cartel wars have multiplied that violence into a different phenomenon. The best comparison, although on a smaller scale, is the way civil unrest exploded in Colombia with the growth of the cocaine market in the 1980s. Mexico’s violence is similar to – but much larger than – the gang violence that erupted in Chicago when millions of illegal alcohol dollars flooded the city. Greedy, ruthless men fought and killed to get their share of the loot. Without the money, violence in Mexico would quickly fade to the much lower historical levels, just as it did in Chicago with the repeal of prohibition.

If large amounts of money were removed from the equation, the demand for guns would decrease for a second reason: guns cost money. And the military-grade arms now in demand cost a lot of money. A single rifle like a Kalashnikov can cost up to a thousand dollars. Machine guns and rocket launchers go for much more. Without the illegal drug money, the cartels would be limited to guns more typical of a street criminal than the Pentagon quality arms they now use.

However, this proposal rests on two other questions: can the United States afford to purge its laws of drug prohibition and how much would those changes affect the Mexican cartels?

The U. S. not only can, but should, change its drug laws from ones based on prohibition to a new approach based on regulating and lowering demand. Almost no one doubts that the current prohibition approach – now ninety-five years old – has been an abject failure. More people are addicted to opiates today than were addicted in 1914; and marijuana, used by fewer than 100,000 people in 1937 when it was outlawed, has been used by over 40% of today’s adults. The latest FBI data shows over 1.6 million drug arrests in 2009, but anyone in America can easily buy any drug in any community in the country. The War on Drugs has cost over $1 trillion, and the only results are increased drug use, the highest imprisonment rate in the world, and high levels of violence and corruption. When one finds himself in the bottom of a deep hole, he should stop digging and look for a way out.

Would changing American drug laws put the Mexican cartels out of business? Replacing prohibition with regulation would hurt the cartels in two ways.

First, illegal drug prices are at least ten times as high as the equivalent legal prices would be. The risk premiums associated with prohibition are the lure that attracts violent gangsters to the business in the first place. Legal heroin was sold for the same price as aspirin. Legal cocaine was cheap enough to be used as an ingredient in Coca-Cola and tooth powder. Marijuana is no harder to grow and process than broccoli. If ninety per cent or more of the money were withheld from the cartels, they would probably get out of the business. But even if they continued as dealers, they could not afford to buy black market military-grade arms.

More important, the very market supporting the cartels would probably disappear. Local American farmers can out produce and undersell Mexican competition. This displacement is already happening in California. Walgreens could buy legal cocaine directly from Colombia, bypassing the Mexican middlemen entirely – or they could grow and process it themselves in Hawai’i. Pharmacists already sell methamphetamine under the trade name Desoxyn. Mexican sources are just not needed.

The way to stop the arms traffic into Mexico is not to erect another form of prohibition scheme guaranteed to fail like all prohibitions must fail. The wise approach, instead, is to replace the current destructive prohibitions that fuel that traffic with a system of demand-oriented regulation controlling the demand side of the market.

Friday, August 13, 2010

A Bottomless Pit of Death

A Bottomless Pit of Death




“Bottomless Pit of Death” headlined a recent Houston Chronicle article about finding many bodies in an abandoned Mexican silver mine”. That headline could serve as a perfect title for the American War on Drugs, or for that matter, any form of prohibition.

The Volstead Act, instituting national alcohol prohibition, went into effect in January, 1920. Less than a week later, unidentified gunmen fired multiple shots at one of the new bootleggers on a crowded street. All of the shots missed him, and luckily missed all of the by-standers as well. Two days later gunmen killed him on another crowded street, and one of the most violent decades in American history began.

Chicago was the Juarez of its day. Mobsters introduced the Thompson submachine gun – a weapon not then used by either the army or the police. Speeding black automobiles with a Tommy chattering from the window as they drove down the street were a weekly occurrence. Bomb blasts and grenades were even more common. Mass killings with six or eight victims were frequent; and many victims were either by-standers or misidentified innocents.

Virtually all of this violence disappeared overnight in 1933 when Prohibition was repealed. Al Capone and Bugs Moran were replaced by Budweiser and Millers beers, and they have not used guns or bombs in any of their marketing disputes in the intervening seventy-five years.

But the street-corner heroin markets of the inner cities showed the same violence on a smaller scale. It returned in a big way with the flood of Colombian cocaine through Miami and later in the crack gangs of the mid-eighties.

What about these markets is so conducive to violence? First, the amounts of money involved are almost beyond imagination. The daily profit from Chicago’s alcohol was probably close to a million dollars a day, not corrected for later inflation. Current estimates have the Mexican drug traffickers grossing over $30 Billion a year.

And a very large part of that money is profit. Heroin, when legal, sold for the same price as aspirin. Now it sells for $100,000 a kilogram on the street. Marijuana is a simple annual herb that should cost no more than parsley or broccoli, yet it sells for more than $200 an ounce. If these drugs were legalized and sold through normal, regulated markets, at least ninety per cent of the traffickers’ money would disappear, and with it would go the reason for the violence and the money to buy the weapons and hire the assassins.

The other problem that illegal traffickers face is that they have no police or courts to protect them. The Chicago bootleggers discovered they did not have to brew their own beer: they could simply hijack the other bootleggers’ trucks, which in turn had to be armed to fight off the hijackers. The seller of a bad batch of hooch or a purchaser who didn’t pay could not be sued, only shot. Marketing wars were not fought with advertising campaigns and discount coupons, but with machine guns and bombs. The same processes are seen in Mexico today.

Illegal, but popular, markets with lots of money lead to crooked cops. One of the latest stories from Juarez is about actual fighting between police units on different sides of the struggle to market drugs. With both sellers and buyers willing participants, traditional police measures are ineffective against black market transactions, and police are led to cooperate with criminals to develop informants and stings. The large amounts of money – and the normally low wages for police – make it a question of whether the police are buying informants or the marketeers are buying protection.

The police also become more violent, substituting direct physical punishment for that which they know the courts will not provide. In one of the most notorious examples, two of the killers in Chicago’s Valentine’s Day Massacre were wearing police uniforms. This crime, in which eight members of the Bugs Moran gang were machine-gunned, was never solved: no killers were identified and no one was ever arrested. Even today when the crime is discussed, experts are divided about whether police were actually among the killers. They all do agree that, in Chicago at that time, a policeman-murderer would not have been unusual. The common saying, with slight, understandable exaggeration, was that Capone had the entire Chicago police force on his payroll.

Conviction of police for crimes of violence have continued non-stop throughout the era of drug prohibition. In 1999, the keynote speaker at the National Association of Police Chiefs said that corruption was the major problem then facing police administration. Convictions in Texas have included police officers caught providing armed escorts to large drug shipments.

Police are also recipients of prohibition violence. In Houston, a major drug transshipment point, a shoot-out involving an undercover operation gone wrong is an almost weekly occurrence. Usually the smugglers are shot, but in a large number of these cases, either the police or bystanders are injured.

One of the major reasons for repealing drug prohibition is to eliminate this resulting violence. Now is the time to replace these modern-day Capones with a pharmaceutical version of Budweiser and Coors. Dispute settlement by gun should be replaced by resolution by the judge’s gavel.

Friday, July 16, 2010

A Bus Named FURTHUR

I sometimes cannot prevent myself from committing poetry.  This time I'm going to inflict it on you:

A Bus Named FURTHUR


In memory of Aldous Huxley, the trailblazer and guide who has led the way, opening the

Doors of Perception for many to take the trip to

Furthur.



1939 International Harvester

1960s sound and film

Day-Glo paints,

Mandalas smeared and loppy.

Destination sign reads “Furthur”.

Are you on the bus –

-- or off the bus?

Neal Cassady’s driving:

Dean Moriarity On The Road again.

Foot down hard, going fast;

Hands in air – he steers by mental force.

Non-stop monolog – Beat rap now decades long enchanting all around but the traffic cop who gets confused and slinks away silently

– not on the bus.



Merry Pranksters careering thru deserts and down to Houston;

Stop at McMurtry’s door:

Larry dazed and enraged

At Blanket Girl naked on his lawn.

You’re either on the bus –

-- or off the bus.

On to Gotham: McMurphy’s on the stage

And foiling Ratched – who missed the bus long ago.



Sometimes a Great Notion: on to Millbrook

And enlightened Guru Tim.

But Tibet chants and Book of Dead are just a killing bore.

Tim’s dropped out --

– and off the bus.



Back on the bus – and furthur west:

The Fillmore waits; Garcia has the band.

Light show flicker/flows and Owsley spikes the brew:

Orange Sunshine for the trip.



If you pass the Acid Test, no need to use the bus.

Your mind’s enough:

The trip is always FURTHUR.

Friday, June 18, 2010

Legalizing Marijuana -- But How?

Legalizing Marijuana – But How?




Many now advocate legalizing marijuana – several surveys indicate that a majority of the population does. The idea is so vaguely worded that it presents two questions: what does legalization mean and how can it be done? The first can be clarified rather easily, but the second presents a tangle of complication.

Those advocating marijuana reform fall into three camps: decriminalization, medical use, and legalization. Decriminalization means removal of criminal penalties from possession for personal use while maintaining criminal laws against growth, distribution and sale. About twelve states have taken this approach (with most retaining small civil fines for possession), as have The Netherlands, Portugal, Germany, Mexico, and Brazil. Other European nations have simply quit enforcing laws against possession. Fourteen states and the District of Columbia allow possession for medical use by those with a doctor’s recommendation, several of these also establishing approved production and distribution systems. The federal government has announced that it will respect these programs. Canada and most of Western Europe also allow medical marijuana. In most respects, recognition of medical use is a form of decriminalization.

The most comprehensive reform being advocated is legalization, or removal of all criminal penalties for growing, processing, distributing, or possession. This would be accompanied by laws regulating places and methods of sale, age of users, and liability rules for misuse or abuse. Taxation would probably follow. Legalization would result in a system much like that used for alcohol today.

Current nation-wide polls show that over sixty per cent, and possibly eighty per cent, of adults favor recognition of medical marijuana, while about forty-five per cent favor legalization. These surveys usually do not distinguish between legalization and decriminalization. Some kind of national reform looks likely, but the methods are problematic.

The major problem comes from the federal structure of the American government. Both the national government and the state governments (all fifty of them!) have independent jurisdictions to make and enforce laws against marijuana. If the federal law is reformed, a person would still be restrained by the law of whichever state she was in; and if a state reformed its law, its residents would still be in jeopardy from federal enforcement. The current efforts of states to allow medical use of marijuana illustrate this problem. Even though today’s national administration has pledged to respect the state laws, the effect of the federal laws on banking, marketing of medicines, education, employment, and other areas of life prevent full implementation of those laws. Federal and state laws must both be changed if reform is to be effective.

Under these circumstances, three approaches are possible. Reform in the states may be pursued first before challenging the federal law; federal law can be confronted first, followed by the states; or the two can be assailed simultaneously.

Groups are currently active on both the state and federal level, but with little coordination between them. The major defect in this approach is that it dilutes resources, scattering people and money among dozens of groups with minimal cooperation between them. The major advantage is that these many groups can create widespread public attention and enthusiasm.

Federal reform could be pursued first, allowing the states to follow at their own rates. This approach was the one followed in the repeal of alcohol prohibition, with some states still retaining prohibitory laws some eighty-five years later. The result is a confusing patchwork of laws across the country, but it does allow localities to control their own destinies.

The third approach is to concentrate on the states first. Pending referenda in California and Washington are examples of this approach. If enough states reform their laws, the federal government will be forced to follow. Federal law, even during alcohol prohibition, was forced to rely on state and local agencies for enforcement. A national police force large enough to enforce drug laws would be prohibitively expensive and most people would refuse to allow that level of federal policing in everyday life.

Even if marijuana were legalized, federal law would need changing to allow medical use. Ending prohibition under the Controlled Substances Act would still have medicinal marketing banned by the Federal Drug Administration. The FDA’s administrative approval for marketing as a drug is practically prohibitive. Normally, approval of a new drug costs several hundred million dollars and takes many years. However, the safety requirements for approval of marijuana can be met from current information, and at least one new study showing the effectiveness of marijuana for pain relief claims to satisfy FDA requirements for a Phase III study (a number of Phase III clinical studies are required for approval), possibly making approval more likely. If marijuana is approved for even one use, the doctrine of off-label prescription means that physicians can prescribe it for any therapeutic purpose and pharmacists may fill those prescriptions.

The question remains about whether to attack DEA scheduling of marijuana as having no medical use, which would allow sales subject to FDA regulation, or to first seek FDA approval, which would force DEA rescheduling. Currently both are being pursued in parallel.

However, a third approach is possible. In the 1990s Congress established a separate method for regulating herbal remedies and dietary supplements. This system allows products to be sold without prior approval but subject to FDA after-market supervision for both safety and misleading claims. Marijuana clearly fits into the definition of many products now subject to that law and is safer than many of them that are also psychoactive like St. John’s Wort and Kava. Congress could easily move marijuana from the CSA to coverage under this system without facing the stigma of legalizing drugs.

Some kind of reform of marijuana laws is probable. However, the route to that reform is more complex than most people assume. More thinking about the best path to reform is necessary.