The Fix's Week in Science: January 11, 2012
Controversy over a 100% proof opiate painkiller, a potential first treatment for crystal meth addiction, and a new definition of recovery.
Despite a nationwide epidemic of opiate painkiller addiction, drug companies are determined to develop pure versions of both oxycodone and hydrocodone, packing 10 times the analgesic power of OxyContin and Vicodine. We'll probably soon learn whether the FDA will approve these high-risk chemicals and, if so, how stringently prescriptions will be regulated: Zogenic, a small San Diego drug shop, has announced its intention to submit its 100% hydrocodone pill, Zohydro, for FDA approval in the next month or so.
The race for this $10 billion-a-year market has shifted into high gear, with two other versions in Phase III trials. Ironically, each is bankrolled by drugmakers forced to pay billion-dollar (or better) fines for illegal marketing of previous opiate painkillers: Purdue Pharma of OxyContin notoriety and Cephalon of Actiq (fentanyl) fame.
With oxycodone and hydrocodone already the top two most-abused drugs in the US, anti-addiction advocates are up in arms at the prospect of turbo-charged "superdrugs" hitting the market in 2013. They argue that a fair benefit-risk analysis has yet to confirm that the gains in pain management of a modest number of patients outweigh the health, economic, and social costs of the far larger number of addicts and abusers nationwide. "I have a big concern that this could be the next OxyContin," says April Rovero, president of the National Coalition Against Prescription Drug Abuse. "We just don't need this on the market."
Big Pharma counters with the innovation argument—purer opiates make for more powerful painkillers for an aging population. Yet public health experts contend that increased potency means increased addictiveness—and that drugmakers have shown little incentive in innovating opiates with less addictiveness. "You've got a person on your product for life, and a doctor's got a patient who's never going to miss an appointment, because if they did and they didn't get their prescription, they would feel very sick," says Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. "It's a terrific business model, and that's what these companies want to get in on."
To make matter worse, Zogenix's hydrocodone is formulated as a time-released but not tamper-resistant pill, making it easy to crush and therefore to abuse. While advocates express doubts that the FDA will seriously consider, let alone approve, such a pill, Zogenic asserts that it has already had extensive discussions with the agency about the drug's formulation.
One Drug Passes, Two Fail Against Crystal Meth [Addiction]
Meth is proving the hardest addiction to treat pharmaceutically. Last fall, the three-drug combo of flumazenil, gabapentin, and hydroxyzine (or the “PROMETA proprietary system,” costing a mere $10,000 a month) proved no better than placebo at decreasing crystal cravings or consumption in a 30-day trial.
New research published in the journal Addiction documents a poor showing by Topamax (topiramate), a drug originally approved for seizures—and so widely prescribed off-label for so many mental conditions that it's earned such street names as “Dopamax,” “Stupamax” and the “supermodel drug” (its side effects include weight loss and brain slowdown). Because Topamax helps some alcoholics stay sober, doctors jumped on it as a possible treatment for cocaine and other stimulant addictions. But results against meth are decidedly mixed: In a 13-week trial of 140 meth addicts, the drug failed to boost abstinence (first prize), but the addicts who managed to stay in the trial and keep taking the pill were more likely to cut their crystal consumption by 25% (second prize).
Unexpectedly, one drug is showing definite promise against meth addiction. Last fall, the San Francisco Department of Health announced that Mirtazapine (remeron), a powerful antidepressant that has been on the market for two decades (and is therefore available as a cheap generic), decreased meth use in a cohort of 60 gay men: After three months, the remeron-takers' rate of positive urine samples had fallen from 73% to 44%, compared to the placebo’s figures of 67% and 63%. Since adherence in the SFDH study didn't even hit 50%, imagine what daily dosing could do. These best-ever anti-meth drug results are prompting plans for larger, longer studies of remeron.
Driving on Methadone [Medscape]
Ex-addicts on methadone maintenance are more than twice as likely as the average to be involved in a traffic accident, according to a new Norwegian study, published in December's Addiction, that matches crash records with drug prescriptions. Among 2,500 people on the heroin substitute, there were 26 vehicle accidents—more than double the average rate (but still a relatively modest number). Yet the authors acknowledge that they had no information about whether the drivers were impaired by alcohol or other drugs, so it would be premature to conclude that methadone poses a driving risk. Methadone is known to occasionally lower levels of functioning, but mainly at the start of treatment, or when dosage is increased.
Take Two Melodies and Call Me in the Morning [The New York Times]
With all this controversy over prescription opiates, it's comforting to learn that doctors are increasingly using music as an analgesic. But does it really work? The data are underwhelming, according to a meta-analysis of 51 studies of more than 3,600 patients. But a new 150-person study at the University of Utah found that as the subjects whose hands were being exposed to electrical shocks registered less pain (as measured by pupil dilation and brain activity) the more involved they became in listening to music. Similarly, a 2009 Swedish study found that children given “music therapy” after minor surgery needed less morphine than others.
Three Quick Questions for Kids on the Skids [Pediatrics]
A new three-question survey about booze consumption can help predict future alcohol problems in youths, according to a study published in last month's Pediatrics. University of Pittsburgh researchers narrowed a standardized list of alcohol queries for adults down to three for kids: how often they drank in the past year, how much they consumed in the past year, and if they had any episodes of binge drinking in the past month. The questions were posed by computerto some 166,165 kids from 2000 to 2007 as part of the National Survey on Drug Use and Health. Turns out that the frequency question is the most predictive of future problems: Both alcohol-related symptoms and alcohol dependence increased with age, from 1.4% (age 12) to 29.2% (age 18), and from 0.2% (age 12) to 5.3% (age 18), respectively.
Recovery Gets a Makeover [Medscape]
What is a definition without specifics? Ask SAMHSA, the Substance Abuse and Mental Health Services Administration, which released an official new definition of “recovery” to start fresh in 2012. Given the agency’s mission, the makeover is broad—and therefore vague—enough to cover not only addicts and alcoholics but every color of crazy in the DSM-V. Predictably, it also skirts all real-world controversies by not getting into specifics like the abstinence vs. moderation debate. Recovery, according to SAMHSA, is a "process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential." The new meaning comes with 12 “guiding principles” starting with “emerges from hope” and ending with “is based on respect.” SAMHSA’s aim is to provide a single set of values with which to both model and measure treatment programs and approaches—in other words, something for everyone to complain about. For more info, go to the SAMHSA website.
- Crystal Meth
- Drug and Alcohol Dependence
- San Francisco Department of Health
- OxyContin and Vicodine
- National Coalition Against Prescription Drug Abuse
- Andrew Kolodny
- Physicians for Responsible Opioid Prescribing
- April Rovero
- Walter Armstrong