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Posts from the ‘Op Eds’ Category

26
Mar

Clearing the Smoke about Marijuana (Part 2)

In the first installment of this series, I discussed the fallacy of rescheduling as part of the “medical” marijuana issue. This final part focuses on the issues brought up by the governors in their rescheduling petition: a so-called “consensus” opinion of doctors who approve of raw marijuana as medicine, and, the issue brought on by the California Medical Association that essentially says research on marijuana cannot go forward without legalization. I will tackle each at a time.

The governors’ petition asserts that there is a “consensus of medical opinion concerning medical acceptability of cannabis amongst the largest groups of physicians in the United States.” In support of this statement, the petition cites the American Medical Association’s (AMA) alleged “reversal” of its position that marijuana should remain a Schedule I substance. However, contrary to the governors’ petition, the AMA does not believe that there has been sufficient research to justify making herbal marijuana itself available as a prescription medication: “Despite more than 30 years of clinical research, only a small number of randomized, controlled trials have been conducted on smoked cannabis.”1

Furthermore, while the AMA’s Report does state that the Schedule I status should be “reviewed,” it limits the purpose of such review to the “goal of facilitating clinical research and development of cannabinoid-based medicines, and alternate delivery methods.”2 AMA does not recommend that marijuana should be rescheduled in order that it can be directly prescribed and dispensed in its raw form to patients. In fact, the AMA recommendation goes on to caution: “This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.” In the body of its report, AMA further clarified its position:

The future of cannabinoid-based medicine lies in the rapidly evolving field of botanical drug substance development, as well as the design of molecules that target various aspects of the endocannabinoid system. To the extent that rescheduling marijuana out of Schedule I will benefit this effort, such a move can be supported.3

The term “botanical drug substance” is derived from an FDA guidance document: “Guidance for Industry: Botanical Drug Products.”4 It refers, not to herbal plant material, but to extracts or similar preparations of the active botanical components. Rather than accepting that marijuana meets the “current, modern accepted standard for what constitute medicine,” the AMA is essentially stating that research into crude marijuana plant material is a dead end.

Rescheduling is not necessary to make marijuana products available for research

A committee of the California Medical Association recently called for the rescheduling of marijuana “so it can be tested and regulated.” However, it is not necessary for marijuana to be rescheduled in order for legitimate research to proceed. Schedule I status does not prevent a product from being tested and researched for potential medical use. The FDA (and its Controlled Substances Staff or CSS) will allow an investigational product containing a controlled substance (including Schedule I substances) to be tested in clinical (human) trials if there is adequate evidence of safety from non-human studies.The CSA imposes stringent security, record keeping, and other requirements, but these apply equally to Schedule I and Schedule II substances.

Under the CSA, the only differences between Schedule I and II are rather technical:Before granting a Schedule I research registration, the DEA will separately inquire whether the FDA believes that the researcher is qualified and competent and the trial design will elicit scientifically valid data.A Schedule I research registration must be renewed each year, whereas research registrations for other controlled substances are valid for 3 years. Schedule I research registrations are protocol, as well as substance, specific. By contrast, a Schedule II registration is valid for research into all Schedule II substances and protocols. Physicians, if they possess registrations to prescribe and administer products containing controlled substances, may conduct research (if permitted by the FDA and the relevant ethics committee) on any Schedule II substance; they need not obtain a separate research registration from DEA.

These additional Schedule I restrictions can delay a research program but are not insurmountable. Furthermore, it may be possible to make minor amendments to the CSA to “equalize” Schedule I and Schedule II research requirements without necessitating a rescheduling of marijuana. Now that would be an interesting thing for governors and the CMA to call for, but apparently neither seemed bothered enough to do the homework required to make such an argument.

Today, Schedule I research certainly does go forward. In a recent pharmaceutical company-sponsored human clinical study investigating a product derived from marijuana extracts, the DEA registered approximately 30 research sites in the U.S. and also registered an importer to bring the product into the U.S. from the U.K., where it was manufactured (this is for a drug called, Sativex, which combines two of marijuana’s active ingredients). What other research projects are happening? That will be the subject of a soon-to-be released report I am working on – stay tuned.

We should also mention the marijuana-based medications already on the market today. Dronabinol (Marinol ®) and Nabilone (Cesamet ®) are concentrated, synthetic versions of the most active ingredient in marijuana – THC – taken as a pill. They are in Schedule III and Schedule II, respectively, and they have been shown to be effective in the treatment of nausea and vomiting caused by chemotherapy in people who have already taken other medications without good results. These have undergone FDA’s process and are completely legal under the Controlled Substances Act.

By contrast to the careful and detailed structure of the Controlled Substances Act, the governors’ petition offers no criteria or guidelines that would clearly identify the scope of legitimate “medical use.” The CMA report also misstates the facts. At present in California, and several other states, it is widely recognized that the concept of “medical use” of marijuana is highly questionable. For payment of a small cash sum, almost anyone can obtain a physician’s “recommendation” to purchase, possess, and use marijuana for alleged medical purposes. Indeed, numerous studies have shown that the most customers of these dispensaries do not suffer from chronic, debilitating conditions such as HIV/AIDS or cancer and are instead otherwise healthy individuals.8,9 Both sides of the argument agree that this system has essentially legalized marijuana for recreational use, at least amongst those individuals able and willing to buy a recommendation.10 The governor’s petition would potentially expand that system on a national scale, permitting any physician in any state to prescribe any form of marijuana for any medical condition. The CMA call, while a great way to generate publicity on legalization, is also predicated on a false assertion that the only way to do research into marijuana is to legalize the drug. Sadly, vociferous calls for rescheduling and legalizing like these simply further muddle and confuse an already highly charged debate.

Kevin A. Sabet, PhD, Policy Consultant and Assistant Professor, University of Florida, College of Medicine, Division of Addiction Medicine, Department of Psychiatry. To read more from Dr. Sabet, visit www.kevinsabet.com or follow him on Twitter@kevinsabet.

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10
Feb

Does Medical Marijuana Increase Drug Use? Read the Facts, not the NORML Fiction

Last week, NORML, the nation’s oldest marijuana legalization organization, published in their weekly newspaper that “medical marijuana has no discernible impact on marijuana use.” NORML cited a new article in the Annals of Epidemiology (a respected journal for sure; the same one that will soon release a study showing that marijuana is significantly linked with car crashes) which critiques an earlier article by Wall and colleagues showing an increase in marijuana use among states with medical marijuana. Essentially, the authors replicated the Wall study using different methods and got different results.

Certainly medical marijuana is a complex issue – one where politics, compassion, ethics and science collide. Sixteen states and D.C. technically have laws allowing marijuana as medicine on the books, but these laws, like other drug laws, vary widely in implementation, so it is tough to even perform studies linking medical marijuana with use changes. NORML doesn’t seem too bothered by that. They went on to cite a Brown University study looking at Rhode Island – a state with a barely discernible medical marijuana program in the first place – as further “proof” that medical marijuana doesn’t impact use. And the usual folks, like Reason Online (I’m just waiting for Maia Szalavitz to get to this as well), essentially republished the NORML line without any critical analysis.

A closer look at these studies shows something a little different, and much more nuanced. First, they completely ignore the more thorough studies that in fact do show increases in use. A major study published in Drug and Alcohol Dependence by researchers at Columbia University looked at two separate datasets and found that residents of states with “medical” marijuana had marijuana abuse/dependence rates almost twice as high than states without such laws.

Most importantly, the studies discussed by NORML miss the mark, by failing to take into account the actual implementation of medical marijuana laws. For example, California did not have “dispensaries” until 2003, seven years after the law officially was on the book. And Rhode Island, the state used in the Brown study, had about 1,500 people in the entire program, so it’s not a revelation that would not see any significant effect on teens. Time will tell, with further study and analysis, how medical marijuana is affecting attitudes and use rates in the long term.

What of course is never talked about is how medical marijuana programs in states that have gone full steam ahead actually work. Rarely mentioned is the fact that, for example, according to a 2011 study in the Journal of Drug Policy Analysis that examined 1,655 applicants in California who sought a physician’s recommendation for medical marijuana, very few of those who sought a recommendation had cancer, HIV/AIDS, glaucoma, or multiple sclerosis. A study published in the Harm Reduction Journal (not exactly an anti-drug mouthpiece), analyzing over 3,000 “medical marijuana users in California, found that an overwhelming majority (87.9%) of those queried about the details of their marijuana initiation had tried it before the age of 19, and the average user was a 32-year-old white male. 74% of the Caucasians in the sample had used cocaine, and over 50% had used methamphetamine in their lifetime. Hardly any had life-threatening illnesses.

Finally, we know from other surveys like the University of Michigan Monitoring the Future that the perceived harm for smoking marijuana occasionally or regularly has been decreasing among the 8th grade since 2007. Social disapproval for smoking marijuana once or twice, occasionally, and regularly has been decreasing among 8th graders since 2007. That has translated into a major increase in use, which is no surprise to researchers who know that attitudes effect youth use rates.

And how can we say that today’s medical marijuana programs aren’t having an effect on youth attitudes toward the drug? “Marijuana is medicine” has become a common slogan in America today, as people like Dr. Christian Thurstone, a Colorado doctor working with kids, recently talked about on National Public Radio.

It’s time to get the legalization lobby out of the business of medical marijuana and instead focus our attention on scientists developing non-smoked marijuana-based medications for the truly ill. That would make this issue no longer the sick joke that it is today.

Author: Kevin Sabet
Source: http://www.huffingtonpost.com/kevin-a-sabet-phd/medical-marijuana-drugs_b_1266922.html

 

5
Jan

Overdosing on Extremism

According to a recent study by the Centers for Disease Control, drug overdoses have increased almost six-fold in the last 30 years. They now represent the leading cause of accidental death in the United States, having overtaken motor vehicle accidents for the first time on record.

One might expect such news to spur politicians to explore new options for drug abuse treatment, prevention and enforcement. Instead, at precisely the wrong time, extremists on both sides have taken over the conversation. Unless we change the tone of the debate to give drug-policy centrists a voice, America’s drug problem will only get worse.

Indeed, moderates have historically been key contributors to both the debate and the practice of effective drug policy. In 1914, Representative Francis B. Harrison, a New York Democrat, worked with Republicans and President Woodrow Wilson to pass the first major piece of federal anti-drug legislation, in response to a surge in heroin and cocaine use.

Other moderates, from Theodore Roosevelt to John F. Kennedy, made drug policy an important part of their domestic agendas. President Bill Clinton worked closely with Bob Dole, the Republican Senate majority leader, on sensible measures like drug courts and community policing. And Vice President Joseph R. Biden Jr. is the reason there is a drug czar in the first place, having pushed the idea for years before President Ronald Reagan approved it.

So where are the moderates now? Certainly, the current political climate makes it hard to come together on any question. Republicans are too timid to touch any domestic policy issue, like effective drug prevention and treatment, that might appear to cost taxpayers more money. And too many Democrats have yet to recognize that drugs are an issue that they and their constituents should care deeply about: after all, drug abuse and its consequences affect the most vulnerable in society in especially harmful ways.

In their place, a few tough-on-crime conservatives and die-hard libertarians dominate news coverage and make it appear as if legalizing drugs and “enforcement only” strategies were the only options, despite the fact that the public supports neither.

This stalemate comes just as a new range of cost-effective, evidence-based approaches to prevention, treatment and the criminal justice system are within our reach. We know much more about addiction than we did 20 years ago; with enough support, we could pursue promising medications and behavioral therapies, even a possible vaccine against some drug addictions.

Meanwhile, smart, innovative law enforcement strategies that employ carrots and sticks — treatment and drug testing complete with swift but modest consequences for continued drug use, or incentives for abstinence — have produced impressive results, through drug courts or closely supervised probation programs.

And drug prevention has moved from a didactic classroom exercise to a science of teaching life skills and changing environmental norms based on local data and community capacity. We now know that recovery from addiction is possible, and that policies that give former addicts a second chance are in everyone’s interest.

Most recently, Gil Kerlikowske, President Obama’s top drug policy adviser, introduced a sensible four-point plan to curb prescription drug abuse: educate prescribers, parents and young people about the dangers of overdose; shut down illegitimate “clinics” that freely sell these drugs; establish electronic monitoring at pharmacies; and encourage the proper disposal of unused medications. Yet his plan received little attention from the news media or Capitol Hill.

Of course, there is no magic bullet for America’s drug problem. The magnitude and complexity of our drug problem require us to constantly refine and improve our policies through thoughtful analysis, innovation and discussion.

Moderates should lead that conversation. To remain silent not only betrays widely shared values of compassion and justice for the most vulnerable. It also leaves policy in the hands of extremists who would relegate a very serious and consequential discussion to frivolous and dangerous quarters.

Kevin A. Sabet, a drug-policy consultant, was a senior adviser in the White House Office of National Drug Control Policy from 2009 to 2011.

23
Dec

California AB 390 – Gone Up In Smoke

AB 390, a bill to legalize marijuana in California, has gone up in smoke at the State Capitol. 

Children need to grow up in safe neighborhoods and attend schools free of marijuana users and sellers.  We need to continue to protect our youth from the dangers of drugs. That starts with stopping the proliferation of pot.

The demise of this disastrous California bill goes to show that our voice was heard at the State Capitol and legislators on both sides of the aisle agreed we don’t want a proliferation of WEED in our streets and communities…our churches…parks and schools.   

Legalizing marijuana is bad public policy and most of the legislators know it.  In my opinion, once the public wakes up and understands the dangers of legalizing marijuana, legislators voting to legalize may find themselves on the wrong side of public opinion.  A lot of voters are going to let their representatives know they will not stand for legalizing such a dangerous drug. 

Marijuana is a dangerous and destructive drug…and we must not rest until the pro-legalizers are defeated once and for all. 

To think some California lawmakers would resort to legalizing the sale and manufacture of drugs to generate tax revenue in which to balance our state budget is an outrage! 

There are many ways to get the economy moving again.  Putting a flood of mind altering drugs on the streets and then taxing their sales is not one of them. 

It doesn’t make sense for our legislators to ban cigarette usage in public places because it is harmful to health, while at the same time saying “yes” to marijuana smoke, which is also carcinogenic.  

California lawmakers recently banned trans fat because it is harmful to health.  And now they want to make marijuana legal because it’s supposedly good for consumption in certain cases?   

If we say marijuana is okay for adults…then what message do do send our children?  That it’s okay for them too? 

How do we expect our youth to say “No!” to drugs when the adults are saying “yes.” 

Why would our public policymakers legalize marijuana, tax it and then go back and use that same money AND MORE for drug prevention programs to convince kids to not smoke dope.  It’s bad public policy. It doesn’t make sense.       

Taxing marijuana is “blood money” plain and simple.  And California lawmakers would have blood on their hands if they voted to legalize this dangerous drug. 

Pot should never be legal for general use in California.  It’s bad for health, it’s bad for our communities, it’s bad for kids and it’s bad for our brains. 

California will go down a dangerous path for which there will be no turning back if voters legalize marijuana.  To think people will smoke pot while driving on our roads, visiting our parks, walking in our neighborhoods, sitting in their backyards (with the odor wafting over our fences) and passing near our schools.  It is a disaster waiting to happen of enormous consequences.  Has anyone given any thought to this? 

Rogue legislators like Tom Ammiano want to legalize marijuana because they say it will be a windfall for the economy.  Many others think it would actually be a drain on the state budget and the root cause of many job losses due to absenteeism and lost productivity. 

There is no guarantee that legalization would undercut the black market, especially if the drug is taxed.  Drug pushers would simply sell it “tax free.”

Legalizers think the revenue from a new marijuana tax will solve California’s budget woes, but AB 390 specifically states that people can grow their own weed, which many will do. How do you tax that?

Where will we get the money to pay for a new watchdog agency to regulate the drug?  And will employees of this same agency be allowed to smoke it during their work breaks since it will be legal?   

AB 390 to legalize marijuana was passed in the California Assembly Public Safety Committee (Tom Ammiano’s committee) on January 12, 2010.  Increase the use of drugs, and our public will be safer? Was there another motive?

President Obama was right to declare he wants to usher in a new era of responsibility; and that includes ensuring marijuana remains classified as an illegal drug.  There’s no excuse for legalizing another harmful drug known kill through the inducements of carcinogens and mental instability.    

Because marijuana is illegal at the federal level, one can imagine California becoming a favored destination for drug buyers – and an exporter of drug dealers.

The “legalizers” will argue we are overcrowding our prisons with people arrested for simple possession of marijuana. The truth is: no one ever stays in jail for more than a day just for possessing it. Anyone that is in jail or prison for marijuana either:

  • Also had a role in distribution; or,
  • Pled down to possession in exchange for information; or,
  • Violated terms of parole/probation, and their original crime was much more serious 

Legalizers say:  “If marijuana is legalized we can tax it and bring in much needed revenue to our state.”

The truth:

  • In 2005, the State of California spent $19.9 billion dollars on substance abuse and addiction or $545.09 per capita on alcohol and tobacco.  But, the State of California collected $1.4 billion dollars of tax revenue or $38.69 per capita on the sale of alcohol and tobacco products.  The costs far exceeded the revenue, and marijuana would likely follow a similar trend.
  • The tax revenue does not account for the additional public health concerns and costs, such as cancer risks due to smoke inhalation or increased mental illness due to prolonged use.

Legalizers say:  “People with medical issues should be able to smoke marijuana to relieve pain or other debilitating symptoms.”

The truth: 

  • There is likely medical benefit from components in the cannabis plant.  This is very different than legalizing smoked marijuana.
  • Medicine should never be determined by voters.
  • The general public does not have the knowledge necessary to vote on whether a particular pill or patch is beneficial for the treatment of heart disease, attention deficit disorder, or diabetes. Why is this different?
  • The 1999 IOM report said that smoked marijuana should generally not be recommended for medical use; we don’t “smoke” medicine. 

Legalizers say:  “Marijuana toxicity has never killed anyone.”

The truth:

  • Marijuana contributes to dependence, mental illness, lung obstruction, lung cancer, memory loss, motor skill disruption and other harms in a way that tobacco does not, and its harms are underappreciated.
  • ER admissions for marijuana-related illness (psychotic episodes, etc.) exceed those of heroin.
  • There have been numerous cases of fatal car and other accidents caused by someone under the influence of marijuana.

Smoked marijuana is not medicine. Pot smoke contains more carcinogens than cigarette smoke and is simply not healthy for you. The U.S. Food and Drug Administration routinely tests new drugs according to a rigorous protocol to prove their safety before they are allowed to be sold to the public as medicine. Marijuana has passed no such test.

Legalization will increase drug use and health care costs. Marijuana is an addictive drug that poses significant health consequences to its users. Recent studies have linked marijuana use to birth defects, respiratory system damage, cancer, mental illness, violence, infertility, and immune system damage.

The latest information from the U.S. Treatment Episode Data Set reports that 16.1% of drug treatment admissions were for marijuana as the primary drug of abuse, compared to 6% in 1992. 
 
Legalization will increase crime-related costs. 75% of children in foster care are placed there because of a parent’s substance abuse. Sexual assault is frequently facilitated by substance use – some experts put the number at over 60%. The U.S. Department of Justice found that 61% of domestic violence offenders also have substance abuse problems.

All forms of marijuana are mind-altering (psychoactive). In other words, they change how the brain works. A lot of other chemicals are found in marijuana, too — about 400 of them, some of which are carcinogenic. Marijuana is addictive with more teens in treatment with a primary diagnosis of marijuana dependence than for all other illicit drugs combined.

Long-term marijuana abuse can lead to addiction; Long-term marijuana abusers trying to quit report irritability, sleeplessness, decreased appetite, anxiety, and drug craving, all of which make it difficult to quit.

Numerous studies have shown marijuana smoke to contain carcinogens and to be an irritant to the lungs. In fact, marijuana smoke contains 50–70 percent more carcinogenic hydrocarbons than does tobacco smoke. Marijuana users usually inhale more deeply and hold their breath longer than tobacco smokers do, which further increase the lungs’ exposure to carcinogenic smoke.

Driving experiments show that marijuana affects a wide range of skills needed for safe driving — thinking and reflexes are slowed, making it hard for drivers to respond to sudden, unexpected events. Also, a driver’s ability to “track” (stay in lane) through curves, to brake quickly, and to maintain speed and the proper distance between cars is affected. Research shows that these skills are impaired for at least 4-6 hours after smoking a single marijuana cigarette, long after the “high” is gone. Marijuana presents a definite danger on the road.

Emergency Room admissions for marijuana-related illness (psychotic episodes, etc.) exceed those of heroin. 

 

 

 

          

15
Dec

CASA Report

Today a full 16 percent of the U.S. population is dependent on alcohol, nicotine or other drugs. Another 27 percent of the general population engages in use of these substances in ways that put themselves and others at risk, including underage and adult excessive drinking, tobacco use, and misuse of pain relievers, stimulants and depressants. For a staggering 43 percent of the nation, then — nearly every other American — addiction and risky substance use are a matter of public health.

Addiction is America’s number one health care and health cost problem. Approximately 30 percent of our federal and state health care spending is attributable to this disease. Across all government spending, the total financial cost is nearly $500 billion annually.

The extent of human misery is incalculable.

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