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.

Friday, June 11, 2010

Screening Children

Screening Children

The American Academy of Pediatricians (AAP) has recommended that doctors screen all of their young patients for alcohol use starting in middle school, the Wausau Daily Herald reported May 15. The AAP Committee on Substance Abuse released a revised policy statement on youth alcohol use on May 1. "A remarkable amount of brain development is still occurring for young people through their 20s," said report lead author Patricia Kokotailo of the University of Wisconsin School of Medicine and Public Health. "This policy statement provides better evidence about how alcohol affects the brains of young people and why it is important to screen children."

Those worried about problems of drug abuse and dependency should approve of this policy. So should those who know that the most effective public health programs focus on prevention and detection, not simply on developing after-the-fact cures.

Alcohol is, without a doubt, the most dangerous drug in society. Long-term alcohol-related diseases cause over 100,000 deaths a year in addition to several thousand acute intoxication deaths, most of these in young people. Over 15,000 die each year in car wrecks involving drivers who have been drinking. Alcohol is the only drug the consumption of which has been causally connected to violent crimes. Domestic violence is the most prominent of these, but homicides and aggravated assaults are also common. Alcohol abuse is also responsible for a significant part of lost productivity (including absenteeism) and workplace injuries.

What should screening accomplish? About two-thirds of the population consumes some alcohol and around ten to fifteen per cent of those develop a dependency on it. Those with alcohol dependencies display most of the abusive behavior, causing the problems described.

Early alcohol use is one of the factors with the highest correlation with later dependencies and abusive behavior. Screening will provide opportunities for intervention and possibly prevent later abuse and dependency. It will also allow long-term longitudinal studies of alcohol use for the first time, creating the data to determine the ways in which alcohol use develops in the individual.

One side effect of this screening may prove almost as worthwhile as the direct benefits. It should also provide a means for studying, predicting, and intervening in the abusive and dependent use of other drugs.

Early use of alcohol has been shown to be antecedent to excessive use of other drugs. Virtually all of those who use other drugs in a destructive fashion first began using alcohol by the age of ten or twelve. Although marijuana is often accused of being a gateway drug – a claim thoroughly rebutted in the 1995 Institute of Medicine report on medical marijuana -- the correlation of early use of alcohol with later abuse of other drugs is much higher than is that of any other activity, significantly higher than that of marijuana use for instance. Identifying, and intervening with, those children using alcohol by their middle-school years should greatly decrease the number of those abusing other drugs as these children mature.

While the number of users of other drugs is miniscule compared to alcohol, it is high enough to raise legitimate social concerns. Excluding tobacco and marijuana, less than ten per cent of the population uses drugs other than alcohol. Of those users, like alcohol users, only around ten per cent develop dependencies or use abusively.

Tobacco use has decreased from a majority of the adult population in the 1950s to around twenty per cent today. However, a much higher percentage – possibly as high as twenty per cent – of the tobacco users become dependent, and diseases causally related to tobacco result in over 400,000 deaths annually.

Many more people use marijuana than use any other illegal drug. Among the young, rates of marijuana use may approach those of tobacco. However, marijuana users develop dependencies at a much lower rate than the rates for other drugs, and those dependencies are much weaker and easily broken. The best estimate is that only about three per cent of marijuana users ever show any signs of dependent or habitual use. Marijuana use has few, if any, health consequences for the user and marijuana has not been shown to have a causal relation to any consequential social harm.

Surprisingly little is known about drug dependency from a medical standpoint. So far debate still rages about whether it is a disease, a disorder, or merely a cluster of symptoms that may evidence other underlying diseases or disorders. Only a few rules of thumb have been agreed on. As already mentioned, early alcohol use is an almost universal precursor. Most of those dependent on drugs, including alcohol, experienced physical or sexual abuse as children. A large majority come from broken or dysfunctional families. Some genetic component or components are probably involved. Attempts at rehabilitation (except in the case of marijuana) are unsuccessful, with the best ones failing at a rate of over eighty percent, a rate that has not changed measurably since first determined among heroin addicts at the Federal Narcotics Farms in the 1930s.

Wide-spread screening of middle school children for alcohol use becomes important for several reasons. It identifies those likely to develop problems with all drugs (including alcohol) before dependencies and patterns of abusive use develop. It provides opportunities to intervene and prevent those dependencies from developing in the first place and to develop effective means for that intervention. But the most important benefit is that it will provide the data from large numbers of longitudinal studies that will eventually provide the scientific and medical knowledge necessary to prevent dependency and abuse problems in the first place.

Friday, June 4, 2010

The Way it Is Sold

The Way it Is Sold

On May 4, Washington, D.C., Assistant Police Chief Peter Newsham was quoted

in the Washington Post as saying, “People don’t feel marijuana is dangerous,

but it is because of the way it is sold.”

A doctor prescribes Desoxyn for a ten-year old patient diagnosed with ADHD. The prescription is filled routinely at a large chain drugstore like Walgreens or CVS at the chain’s standard price of $4.00 for a month’s supply of a generic drug. No one worries about the strength or purity of the drug because it was manufactured and distributed by a factory certified as following Best Manufacturing Processes and inspected by the FDA. Some of the pills will be turned over to the school nurse who will see that the child takes them when scheduled during school hours.

On the same day in the same city, a teenager tried to buy some crystal meth from a street dealer. When a police officer approached, the seller drew a gun and tried to run. The shoot-out ended with both the dealer and his young customer dead. When the police lab analyzed the drugs, they were found to be contaminated with several toxic substances. A search of the dealer’s motel room found a portable meth lab and some of the dangerous substances used in its manufacture.

The first of these stories is the outline of events occurring in the United States each week. The second is a composite of factors common in episodes also occurring daily in this country. The factor they have in common is that they both feature the same drug: methamphetamine.

Methamphetamine was invented almost a century ago, and from about 1940 until the mid 1960s was one of the leading prescription drugs. The amphetamine-like stimulants (amphetamine, methamphetamine, and Ritalin) as a group were the drugs most often prescribed during this period. They are grouped together not only because they are chemically similar, but because users cannot normally tell them apart. Today these drugs are primarily prescribed for attention spectrum disorders, extreme obesity, and some sleep disorders. Some doctors also prescribe them for the off-label use of increased mental functioning, or “brain-boosting”. Professor Rasmussen estimates that, counting these three drugs together and combining legal and illegal users, the percentage of the population using them today is roughly the same as in their heyday of the 1960s.

Meth for illegal use comes from three sources. A large amount, although only a small part of the total, is diverted from legal sources. Some of that comes from pharmacies, either through fake prescriptions or through burglaries. Holders of legitimate prescriptions provide a larger share by giving or selling some of their drugs to friends or through children rifling their families’ medicine cabinets.

By far the largest part of illegal meth is smuggled into the country. Most of that comes from small, unregulated factories in Mexico, but a portion comes from South and Southeast Asia. Mexican meth is a smaller trade than is the marijuana, cocaine, and heroin from that country, but it still contributes to the overheated competition between the drug cartels now causing so much damage in that country.

A very small part of the illegal meth in this country is produced in small “cookers” for local use. Many of these are set up in temporary locations like motel rooms and produce less than a pound of the drug. However, these cause damage greatly disproportionate to the amount of meth they produce. The people operating them are usually untrained in chemistry, trying to follow unreliable recipes they have gotten from the Internet or from other cookers. Their attempts often catch fire or explode, and the dangerous chemicals used and produced are thrown away so that intense local environmental damage results. Cleaning up these small disasters is tedious and expensive and exposes the responders doing the cleaning to great personal danger. If all of these small meth cookers were to disappear, the drug supply would not be appreciably diminished except in a few small isolated localities, but the dangers and harms to the surrounding communities would disappear with them.

Nothing about this portrait of a drug market should surprise anyone. It could also apply in detail to the market for alcohol during Prohibition.

Just as with Desoxyn, a legal market for potable alcohol existed. Doctors (including dentists and veterinarians) could prescribe up to a pint a week, and many drugstores became nothing but outlets for medicinal brand name whiskeys. Walgreens went from 20 stores to 525 during the decade. A family could have up to ten gallons a year of sacramental wines, and priests and rabbis were vested with authority to procure and distribute it. Since no official registry for rabbis existed, Jewish congregations sprang up in surprising neighborhoods with unexpected ethnicities. Farmers (meaning any householder) could “preserve” up to 100 gallons of their fruit crop by fermenting it. The market for grapes exploded, with California vineyards making more money shipping grapes than they had ever made selling wine.

Most of the market for alcohol was met by imports, although the primary source was Europe, not Mexico. While some of this liquor was the reliable brands people had long purchased, most of it was counterfeit: flavored grain alcohol with fake labels pasted on. One German company even marketed Black and White Horse Scotch.

And local cookers poisoned and polluted their neighborhoods as well. The South had a long tradition – dating back to the eighteenth century – of making moonshine. Their bootleggers stepped up production to meet the demand with sub-standard product, burning down the forests for fuel for their stills and dumping their wastes in the streams.

In the cities small distilleries presented the same kinds of problems that meth cookers create in rural areas eighty years later. Bootlegging gangs would pay tenement dwellers to operate small stills in their apartments. The five to fifteen dollars a week those stills brought in was a major incentive to these amateur operators, but these operations caused real problems to the neighbors in these crowded dwellings. The constant odors and heat and the continuing foot traffic were bad enough, but the frequent fires and explosions in the firetrap buildings became a serious public safety concern.

The sad fact is that the same stories can also be found two hundred years earlier when the British Gin Acts of the 1730s tried to impose prohibition on London. Einstein defined insanity as repeating the same experiment but expecting different results. Our current attempts to prohibit sales of drugs can only be seen as insane.