Status of Medical Marijuana to be Tested in U.S. Appeals Court

Ten-year old petition could change everything.

Medical marijuana advocates will finally have their day in federal court, after the United States Court of Appeals for D.C. ended ten years of rebuffs by agreeing to hear oral arguments on the government’s classification of marijuana as a dangerous drug.

A decision in the case could either finish off medical marijuana for good, or else upend the fed’s rationale for its stepped-up war against the medical marijuana industry. Americans for Safe Access v. Drug Enforcement Administration asks that the federal government review the scientific evidence regarding marijuana’s therapeutic value. The D.C. Circuit Court of Appeals has agreed to do so in October.

The original petition, filed by the Coalition for Rescheduling Cannabis (CRC) in 2002, has languished in obscurity, but recent moves to have marijuana rescheduled from its status as a Schedule 1 drug—a class that includes heroin—have increased in the wake of America’s Civil War over medical marijuana.  “This is a rare opportunity for patients to confront politically motivated decision-making with scientific evidence of marijuana’s med efficacy,” said Joe Elford, chief council for Americans for Safe Access, the group that successfully challenged the denial of the original CRC petition. “What’s at stake in this case is nothing less than our country’s scientific integrity and the imminent needs of millions of patients.”

The Controlled Substance Act reserves Schedule 1 for drugs that “have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is lack of accepted safety for use of the drug or other substance under medical supervision.”

Recently, an article by Dr. Igor Grant in the Open Neurology Journal argued that marijuana’s Schedule 1 classification and surrounding political controversy were “obstacles to medical progress in this area.”

Seventeen states have now adopted some form of medical marijuana law, but the nascent field remains in limbo due to federal regulations about the illegality of marijuana use. Over the past year, the U.S. Justice Department has stepped up its pressure on medical marijuana purveyors, culminating in dozens of indictments, seizures, and shutdowns. Most recently, the Los Angeles City Council simply threw up its hands and banned most marijuana dispensaries in the city. But it’s not even clear if the ban on state-legal dispensaries is itself legal. A pot collective in Covina recently won its challenge to a blanket ban on pot sales in unincorporated areas of Los Angeles County in the state’s 2nd District Court of Appeal. As a Los Angeles Times editorial aptly put it, “we’re confused about how to legally restrict a quasi-legal business.”

According to Chris Roberts, writing in the SF Weekly, “the court hearing would be the first time the medical merits of cannabis would be examined in a federal courtroom since 1994.” At the core of the argument is the federal government’s contention that the marijuana plant has no redeeming medical value, as opposed to the mountain of scientific studies suggesting that marijuana may be applicable in the treatment of glaucoma, cancer, chronic pain, and possibly other conditions, such as multiple sclerosis.

Graphics Credit:   http://en.wikipedia.org/

Misdiagnosing Fetal Alcohol Spectrum Disorder

Facial abnormalities not present in most cases.

Back in 1967, when a French pediatrician tried to alert doctors to developmental problems he had recognized in the children of alcoholic mothers, he didn’t make much progress.  A few years later, pediatrician David Smith began seeing the same sorts of trouble as Paul Lemoine had seen in France. Hoping to draw more attention to the problem, Dr. Smith coined the term fetal alcohol syndrome, or FAS. It was a successful gambit. By now, almost everyone has heard of the disorder. And once NIAAA-funded studies had succeeded in proving that the problem did not only affect the children of poor alcoholic women, research on it has been a major theme at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) ever since. Fetal alcohol disorders may in fact be the most common and preventable form of developmental disorder in the world.

Typically, physicians have used three basic features to diagnose full FAS:

--Characteristic facial abnormalities
--Growth deficits
--Nervous system dysfunctions

But there’s a problem: Fetal Alcohol Syndrome is considered a spectrum disorder, meaning that it includes variations on the full pattern of birth defects. Fetal Alcohol Spectrum Disorder (FASD) doesn’t always show all three of these diagnostic features. In the early going, therefore, clinicians missed a lot of children suffering from FASD, catching only full FAS in the diagnostic net. Kenneth Warren, acting director of the NIAAA, said in a press release that “if you didn’t have the distinctive facial features, you weren’t diagnosed with FAS. If you didn’t have a growth deficit, you weren’t diagnosed with FAS.”

All of this means that recognizing the effects of fetal alcohol exposure is trickier than first thought. For example, FASD is often mistaken for attention deficit hyperactivity disorder (ADHD). The distinction certainly matters, because stimulant medications, which work for some kids with ADHD, are of no use to children with fetal alcohol spectrum disorder. Now, a long-term study of heavy drinking during pregnancy by researchers at the University of Chile appears to nail down the fact that most children regularly exposed to alcohol in the womb do not show the distinct facial characteristics of fetal alcohol syndrome (FAS). Rather, said collaborators on the study at the U.S. National Institute of Child Health and Human Development (NICHD), abnormalities of the nervous system and behavioral problems like language delays, hyperactivity, and attention deficits are far more reliable diagnostic clues.

In the study, investigators interviewed a group of 9000 women in Santiago, Chile, and eventually matched 101 pregnant women who drank four or more drinks a day with a control group of pregnant non-drinkers. The study followed the children until the age of 8. The investigators found “functional neurologic impairment” in 44 % of children whose mothers consumed four or more drinks per day. In contrast, only 17 % of the alcohol-exposed children showed any abnormal facial features. 

“Our concern is that in the absence of the distinctive facial features,” said Devon Keuhn of the NICHD in a prepared statement, “health care providers evaluating children with any of these functional neurological impairments might miss their history of fetal alcohol exposure.”

The NICHD University of Chile Alcohol in Pregnancy Study is an ongoing project.

Photo Credit: http://en.wikipedia.org

Broken Treatment: How the Addiction Industry is Failing its Clients

It’s not medical. It's not psychiatric. What is it?

1. Most clinicians who treat addicted patients are counselors, not physicians; thus they cannot prescribe medication and they generally don’t “believe” in the use of medication for addictive disorders.

2. Most patients have medical insurance that excludes or severely limits treatment of addictive disorders, so payment for service is not good. This situation may change in the near future with the advent of healthcare reform in the United States.

So writes Dr. Charles O’Brien of the University of Pennyslvania Perelman School of Medicine, in a recent article for The Dana Foundation’s website.  In his article—“If Addictions Can Be Treated, Why Aren’t They?”—Dr. O’Brien asks a basic question: “Why are most patients not even given a trial of medication in most respected treatment programs?”

Even though pharmaceutical companies have throttled back on their interest in anti-craving drugs in recent years, there are, in fact, a few medications recognized by the FDA, primarily for use in the treatment of alcoholism. But they are not much in favor, and O’Brien believes he knows why:

The answer seems to be that there is a bias among treatment professionals, perhaps passed down from past generations when addictions were not understood to be a disease. Medically trained personnel are minimally involved in the addiction treatment system and most medical schools teach very little about addiction so most physicians are unaware of effective medications or how to use them.

What is on offer at most addiction treatment facilities is not actual rehabilitation, but rather short-term detoxification. And what we’ve learned from neuroscience is that taking away the drug is only stage one. The addiction remains, the reward and memory systems still operating erratically. We understand some of this circuitry better than at any time in history, but the concrete effects of these insights at the level of the community treatment clinic have been small to nonexistent. Money, of course, is part of it, since addiction has only recently, and sporadically, gotten the attention of funding agencies in the public health community. 

Health journalist Maia Szalavitz, writing at Time Healthland concurs: “Unlike most known diseases, the treatment of addiction is not based on scientific evidence nor is it required to be provided by people with any medical education—let alone actual physicians—according to a new report.” The report in question, from Columbia University’s National Center on Addiction and Substance Abuse (CASA), notes that most people are shoehorned into a standardized approach built around the 12 Step model of Alcoholics Anonymous. “The dominance of the 12-step approach,” writes Szalavitz, “also leads to a widespread opposition to change based on medical evidence, particularly the use of medications like methadone or buprenorphine to treat opioid addictions—maintenance treatments that data have show to be most effective.”

  Szalavitz also believes she knows why, and her thinking is similar to O’Brien’s. “Other medications that are known to treat alcohol and drug addiction, such as naltrexone, are also underutilized,” she writes, “while philosophical opposition to the medicalization of care slows uptake.”

There is a straightforward reason for considering the use of medication in the treatment of addiction: strong suggestions of recognizable genetic differences between those who respond to a given medication, and those who don’t. As O’Brien explains, a prospective study now in progress will be looking to see if alcoholics with a specific opioid receptor variant show a better outcome on naltrexone than those with the standard gene for that opioid receptor. And if they do, the FDA may allow a labeling change “stating that alcoholics with this genotype can be expected to have a superior response to naltrexone.”

But that won’t be happening tomorrow. In the meantime, we are stuck with the addiction treatment industry as it is. “The [CASA] report notes that only 10% of people with substance-use problems seek help for them,” Szalavitz concludes. “Given its findings about the shortcomings of the treatment system, that’s hardly surprising.”

Photo Credit: Creative Commons

John Berryman and the Poetry of “Irresistible Descent”

“The penal colony’s prime scribe.”

“Will power is nothing. Morals is nothing. Lord, this is illness.”
—John Berryman, 1971

A year before he committed suicide by jumping off a Minneapolis bridge in 1972, Pulitzer Prize-winning poet John Berryman had been in alcohol rehab three times, and had published a rambling, curious, unfinished book about his treatment experiences. Recovery is a time capsule. If you think we have little to offer addicts by way of treatment these days, consider the picture in the 60s and 70s. In Recovery, treatment consists almost entirely of Freudian group analysis, and while there is regular talk of alcoholism as a disease, AA style, there is no evidence that it was actually dealt with in this way, after detoxification.

Best known for “Dream Songs,” Berryman taught at the University of Minnesota, and was known as a dedicated if irascible professor. Scientist Alan Severence, Berryman’s stand-in persona in the book, comes into rehab hard and recalcitrant, despite his previous failures: “Screw all these humorless bastards sitting around congratulating themselves on being sober, what’s so wonderful about being sober? Great Christ, most of the world is sober, and look at it!” And he is suffering from “the even deeper delusion that my science and art depended on my drinking, or at least were connected with it, could not be attacked directly. Too far down.”

Berryman was a difficult man, and knew it. He quotes F. Scott Fitzgerald: “When drunk, I make them pay and pay and pay and pay.”

Alcoholics, writes Berryman, are “rigid, childish, intolerant, programmatic. They have to live furtive lives. Your only chance is to come out in the open.” Berryman catches the flavor of group interaction after too many hours, too much frustration, and too much craving. One inpatient lashes out: “You’re lying when you say you do not do anything about your anger. You get bombed. It is called medicating the feelings, pal. Every inappropriate drinker does it. Cause and effect. Visible to a child. Not visible to you.”

Berryman was a shrewd observer, a singular writer, and, after all, a poet. He is extraordinary on the subject of alcoholic dissociation: “I found myself wondering whether I would turn off right towards the University and the bus home or whether I would just continue right on to the Circle and up right one block to the main bar I use there, and have a few. Wondering. My whole fate depending on pure chance…. as if one were not even one’s own actor but only a spectator.”

Berryman puts it all together in a horrific capsule description of the “irresistible descent, for the person incomprehensibly determined.”

Relief drinking occasional then constant, increase in alcohol tolerance, first blackouts, surreptitious drinking, growing dependence, urgency of FIRST drinks, guilt spreading, unable to bear discussion of the problem, blackout crescendo, failure of ability to stop along with others (the evening really begins after you leave the party)… grandiose and aggressive behavior, remorse without respite, controls fail, resolutions fail, decline of other interests, avoidance of wife and friends and colleagues, work troubles, irrational resentments, inability to eat, erosion of the ordinary will, tremor and sweating… injuries, moral deterioration, impaired and delusional thinking, low bars and witless cronies….

Berryman had no illusions about his failed attempt to hide behind the mask of a social drinker: “It seems to be loss of control. Unpredictability. That’s all. A social drinker knows when he can stop. Also, in a general way, his life-style does not arrange itself around the chemical, as ours does. For instance, he does not go on the wagon…”

In the end, he was "pleading the universal case of hope for abnormal drinkers, for all despairing and deluded sufferers fighting for their sanity in a world not much less insane itself and similarly half-bent on self-destruction…”

As the head nurse in the facility tells the group: “You are all suffering from the lack of self-confidence… often so powerful that it leads to consideration of suicide, a plan which if adopted will leave you really invulnerable, quite safe at last.”

And as Saul Bellow wrote in the introduction to Recovery: “At last there was no more. Reinforcements failed to arrive. Forces were not joined. The cycle of resolution, reform and relapse had become a bad joke which could not continue.” Berryman agreed. Toward the end, he wrote: “I certainly don’t think I’ll last much longer.”

“There’s hope until you’re dead,” a woman tells him during his final stay in rehab. Sadly, that hope ended a few months later.


Photo posted by Tom Sutpen for the series: Poets are both clean and warm

The Summer Olympics and the “War on Doping”

 
Time for a change in strategy?

The Summer Olympics are fast approaching, and that can only mean one thing: drugs. After more than a decade, you might wonder, how goes the so-called “War on Doping?”

Not so good, but thanks for asking. The World Anti-Doping Agency, established in 1999 and backed by the UNESCO anti-doping convention, will be operating 24/7 during the games, protecting the “purity” of Sport, trying to ferret out everything from cannabis and cocaine to steroids and arcane metabolites unfamiliar to the world at large. Marijuana as a “performance enhancing” drug? Doesn’t sound likely, but cannabis derivatives are on the banned list anyway. As Bengt Kayser and Barbara Broers of the Institute of Movement Sciences and Sports Medicine at the University of Geneva write in the Harm Reduction Journal, marijuana seems to have been included “largely because of pressure from the ‘war on drugs’ movement, even though there are no known proven performance enhancing effects but rather evidence for the contrary.”

No matter. That’s just for starters. As in life, an athlete can be busted for a banned substance taken days earlier, in some other recreational context, and not intended as a sports enhancer, if the metabolites linger too long in the body. The current policy, Kayser and Broers write, “is still essentially based on repression and surveillance from a zero-tolerance viewpoint.”

Did they say “surveillance?” Top athletes are not like you and me. Jocks operate under a “strict liability” rule: It doesn’t matter how it got in your body, or why. If they find proscribed metabolites, you’re busted. It’s entirely possible to get banned from your sport for life. In 2003, British sprinter Dwain Chambers tested positive for a proscribed substance and was subsequently banned from competition for life by the British Olympic Association. (Chambers recently won an appeal, and continues to compete.)

And to make sure that the Olympic Committee can be diligent about the ever-growing list of banned substances, Olympic-level athletes are subject to something called the “whereabouts” rule, say the authors. Elite athletes must “inform the anti-doping authorities where they will be each day of the year, to allow unannounced out-of (and in)-competition testing…” This requirement is clearly impossible for almost anyone to honor, certainly including globetrotting athletes. But Sebastian Coe, chairman of the London Organizing Committee for the Olympic Games, didn’t let even a ray of ambiguity enter the picture, stating: “I don’t think there is room for drugs cheats in sport.”

However inartfully phrased, this sentiment reflects the Olympic Committee’s desire to increase testing, even though the Geneva sports scientists believe that the “probability for false positives rises with the number of tests performed, as well as with a drop in prevalence of actual doping. Furthermore, for some forms of doping practices, there exist no laboratory tests.” The result? “A greater number of tests would lead to a greater number of false positives, wrongly accusing innocent citizens.”

In fact, you can now be busted even though no trace of a banned drug was found in your blood or urine. Here’s how it works:

Longitudinal testing, looking for fluctuations in certain blood parameters compatible with doping, is now also being introduced. This practice, known as the "athlete biological passport" (ABP), has recently led to the first indictments of athletes, based on indirect indices of presumed doping rather than laboratory tests directly showing the presence of the forbidden substance or their metabolites.

This practice is even shakier, write Kayser and Broers, producing even more false positives “due to analytical variability and outlying individual patterns resulting from the effects of behavior (training, altitude exposure) and genetics.

But the purpose of anti-doping—to celebrate the “clean” and upright athlete as exemplar of everything good and fair—is unrealistic, say the authors. “Doping has always been a part of sports…. Performance enhancement is a logical and essential ingredient of competitive sport. Athletes look for ways to get better, by changing their training paradigm, by eating differently, by taking vitamins, by taking licit medication, by taking supplements.” In short: “The line between licit and illicit fluctuates and has dimensions that can be perceived as arbitrary.”

The essay asks us to consider whether anti-doping tests might one day be logically applied to coaches, trainers, and referees as well—not to mention students studying for a final exam.

So what do we do? Just throw the doors open to any and all drug taking at the Olympics? Since the paper was published in the Harm Reduction Journal, the authors have some thoughts on that. “The argument that it would change sports into an arena akin to Formula 1 where the best engineering team wins is only partly correct,” they write. Which is only partly reassuring. But the authors hasten to argue that “such a scenario is already in place anyway; today well-assisted athletes may engage in complex training regimes and strategic doping while remaining undetected.” They advocate shortening the list of forbidden substances, banning only those with “actually proven performance enhancing effects and major health hazards.” In amateur sports, the authors urge the establishment of so-called steroid clinics, where jocks could get syringes, anonymous service, and professional advice from medical staff.

It would require a major change of heart, and a whole different way of viewing competitive sports. Throttling back the anti-doping program would not sit well with many sports parents of young athletes. The authors are aware of this need, and note that “since athletic careers often start very early, the protection of young talents would be mandatory.”

As a former collegiate athlete, I don’t have an answer to this dilemma. Not even a clue, really. Testing is cumbersome and intrusive and puts the innocent under suspicion. On the other hand, performance-enhancing drugs are unfair and unevenly applied—but so are things like good coaching and state-of-the-art equipment. The answer, perhaps, is to begin viewing anti-doping efforts as wholly distinct from drug war efforts—different rationale, logistics, and deployment.

Kayser B, and Broers B (2012). The Olympics and harm reduction? Harm reduction journal, 9 (1) PMID: 22788912

Photo Credit: http://www1.skysports.com/

Cigarettes: Should the FDA Mandate a National Taper?

Addiction expert calls for reduced-nicotine tobacco.

For years now, nicotine researcher Neal Benowitz has been a man on a mission. Dr. Benowitz, a professor of medicine at the University of California in San Francisco, has been pushing a Big Idea about how to eliminate cigarette smoking in America: Reduce the amount of nicotine in cigarettes.

In essence, Benowitz is calling for a national nicotine taper. Whether the FDA is interested remains an open question. But the result, several years down the road, would be a nation of teenagers confronted with only weakly addictive tobacco products.

It is an old idea, often viewed with great suspicion because of the failure of “light” and “low-tar” cigarettes to reduce nicotine intake, and in fact causing smokers to smoke harder. But Benowitz, one of the nation’s premier tobacco scientists, believes that when it comes to the roughly one out of five Americans who still smoke, a new generation of so-called “low-nicotine delivery” cigarettes is the answer. 

In a controlled study of 135 smokers of various ages, participants smoked cigarettes with progressively lower nicotine over a two-year period, and did so “without evidence of compensation”—meaning that they did not smoke more cigarettes or smoke differently when using the low-nicotine offerings. This varies dramatically from the behavior associated with light cigarettes and special filters—innovations that were marketed as “safer” cigarettes—that simply increase ventilation. The light cigarettes themselves contain the same amount of nicotine as a “regular” cigarette. And smokers quickly learn to puff harder, or cover small holes in the filter paper with their fingers, in order to extract more nicotine from each cigarette.

But with low-nicotine delivery cigarettes, you can’t get more nicotine, no matter what kind of smoker’s gyrations you perform. And the result, according to a paper by Benowitz and coworkers in Cancer, Epidemiology, Biomarkers and Prevention, is that “when the nicotine content of cigarettes is progressively decreased at monthly intervals over 6 months there is a progressive decline in nicotine intake by smokers, with only a small degree of compensation at the lowest nicotine content levels.”

The two-year study was randomized but unblinded, in order to simulate situations in which smokers are fully aware of using cigarettes with progressively less nicotine. A control group smoked their usual brands of cigarettes throughout the study. Benowitz, who led the studied, said in prepared remarks that the U.S. Food and Drug Administration (FDA) now has the authority to regulate the nicotine content of cigarettes sold in the U.S. (Benowitz is a member of the FDA’s Tobacco Products Scientific Advisory Committee.) “The idea is to reduce people’s nicotine intake, so that they get used to the lower levels, and eventually get to the point where smoking is no longer satisfying.”

The study was small, and there were dropouts. As always, further long-term study will be needed to track smokers during this kind of long-term nicotine taper. Traditionally, tapering has not been an effective method of breaking a nicotine addiction. But the reason for that may have to do with the easy availability of full-strength cigarettes in every store and gas station. The obvious goal for Benowitz is the reduction of nicotine in cigarettes to the point where they are no longer addictive. But would a robust black market in strong cigarettes leap up if nicotine reduction were a federally mandated program?

“Progressive reduction of the nicotine content of cigarettes as a national regulatory policy might have important potential benefits for the population,” the authors write, adding that “some people who had no intention of quitting upon entry into the study had… either quit spontaneously or were thinking about quitting in the near future after smoking reduced-nicotine content cigarettes.” Low-nicotine cigarettes could be produced by extracting nicotine from existing tobacco, or by genetically engineering tobacco with a lower nicotine content.

“Adolescents initiate smoking for social reasons, with friends, and later begin to smoke for pharmacologic reasons related to dependence,” the authors conclude. “Presumably a cigarette with very low nicotine content would be less likely to support the transition from social to dependent smoking, although the threshold level of nicotine to prevent this transition is not yet known.”

Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, & Jacob P 3rd (2012). Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 21 (5), 761-9 PMID: 22354905

Photo Credit: http://chronicle.uchicago.edu

Drug Links, Various

Pharmacology, Politics, and Recovery

* USA Today article on Opana abuse rivalling Oxy abuse.

* US Attorneys Crack Down on California Medical Marijuana Dispensaries.

* Downloadable reports from Alcohol Justice, an industry watchdog group.

* With regard to the approval of Lorcaserin as a diet pill, here's the saga of Phen-Fen--how a blockbuster diet pill died.

* Why the Dutch "weed pass" won't work.

* Cigars won't save you: Cigars cause your body similar problems as cigarettes.

* Playwright Sam Shepard on his stint in rehab: “I finally did AA down on Pico Boulevard. I said, 'Don’t put me in with Elton John or anything, just throw me to the lions.’”

* 4,848 and 390: number of medical marijuana providers in Montana in March 2011 and June 2012, respectively.

* Andrea Mitchell talks to NIDA's Nora Volkow

* Listen to the talking urinal cake: Don’t drive drunk

* Feds say celebrity psychiatrist Dr. Drew was paid by Glaxo to talk up antidepressant on TV.

* Reactions to Marc Ambinder's GQ piece on Obama and the Drug War

* Lengthy interview with Drug Czar Kerlikowske by Mike Guy at The Fix:


Graphics Credit: http://tucsonvelo.com