FDA Recognizes ‘Drinking Less’ as Acceptable Outcome

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“Sobriety Does Not Have to be Main Goal of Alcoholism Treatments, FDA Says.” An article by this title was cited by “Join Together” – a daily addiction news service from the Partnership for Drug-Free Kids – as a “most read” article for last month. The “news” was that in February, FDA issued an official draft to guide development of drugs for the treatment of “alcoholism” that allows not only for abstinence as an outcome of studies showing efficacy of medications for their approval for clinical use but also allowing for a pattern of reduced drinking – described as “no heavy drinking days” – as an outcome.

Heavy drinking days are defined as more than four standard drinks per day for a male or more than three standard drinks for a female.

The FDA points to the World Health Organization definition that “alcoholism” is “generally taken to refer to chronic continual drinking or periodic consumption of alcohol which is characterized by impaired control over drinking, frequent episodes of intoxication, and preoccupation with alcohol and the use of alcohol despite adverse consequences.”

Why Are Abstinence and “Drinking Less” Acceptable?

In short, the FDA guidelines officially recognize that abstinence is not always attainable in clinical settings and that there can be significant benefits when drinking is reduced. Yet for some time now, researchers doing studies in this area have considered “percent subjects with no heavy drinking days” to be an efficacy end point recommended by the FDA. And that would include as successful responders to treatment both abstinent individuals and those engaging in non-risky drinking. FDA spokesperson Eric Pahon affirmed, “The ‘new’ guidelines are not much of a change – it’s just that we’ve finally written it down so there’s a clear, written indication of FDA’s current thinking on the topic.”

However, Mark Willenbring, M.D., who now directs Alltyr treatment clinic in St. Paul, MN said, “When I was director of treatment and recovery at the NIAAA [he left that position about 6 years ago], we worked very, very hard to get the FDA to go this far. I’m very pleased that our efforts paid off. It took about 10 years.”

What Are Low-Risk Drinking Levels?
According to the National Institutes of Health, research demonstrates “low-risk” drinking levels for men are no more than 3 drinks on any single day or no more than 14 drinks per week. For women, “low-risk” drinking levels are no more than 3 drinks on any single day or no more than 7 drinks per week. (Standard drinks are defined as containing 14 grams of alcohol, as would be found in a standard shot of liquor, a 12-ounce bottle of beer, or a 5-ounce glass of wine.)

Pahon points out that how much people drink is a “surrogate endpoint.” In other words, it’s not a direct measure of how someone feels or functions. Studies that show these physical and social impacts would be long and large and may be impractical. “Alcoholism carries profoundly destructive physical, mental and social consequences,” said Pahon. “What we want is to ensure that the widest range of safe, effective, and high-quality treatments are available to help treatment professionals and patients fight it.” And studies show that lowering heavy drinking to “low-risk” daily limits is sufficient to avoid most of the physical and psychosocial consequences of alcoholism. (Comments about the FDA’s recommendations can be submitted until April 13, 2015 at regulations.gov.)

Some people are interpreting the FDA’s new guidelines to mean that the FDA has accepted a ‘harm reduction’ approach to… ‘alcoholism.’-Anne Fletcher

Some people are interpreting the FDA’s new guidelines to mean that the FDA has accepted a “harm reduction” approach to treatment of “alcoholism.” However, the FDA avoids the term harm reduction, preferring to use “non-risky drinking” to describe an acceptable outcome for alcoholism in addition to an abstinence outcome.

Misinterpretations, Misunderstanding & Unrealistic Expectations

Anytime an issue touches on “harm reduction,” a heated discussion ensues among people working in the addiction field and those in recovery, as it did in the comments section of the “Join Together” article. It did not appear that a number of people had read the FDA’s guidance paper, understood its intention, nor even grasped the intent of harm reduction.

Comments included concepts such as the following:

  • Feedback that the FDA is not acting responsibly and is giving into big pharma lobbying.
  • Thoughts about keeping people on meds for as long as possible and getting them “hooked” on yet another substance.
  • Concerns about turning alcoholics into social drinkers (and how that’s not possible).
  • Mention that another country is reintroducing abstinence into its legal system because after many years of using harm reduction, they realize this is not working.

FDA’s Pahon responded, “We issued our recommendations to help with clinical development of drugs that treat alcoholism, describing alternatives to abstinence-based endpoints that have often been considered unattainable in clinical trial settings and that might be considered a hindrance to clinical development for drugs to treat alcoholism. While total abstinence from alcohol is desirable, reducing heavy drinking to within low-risk daily limits presents an alternative goal in drug development so more treatments may be developed.”

While total abstinence from alcohol is desirable, reducing heavy drinking to within low-risk daily limits presents an alternative goal in drug development so more treatments may be developed.-Eric Pahon, FDA

The truth is that currently, we only have three FDA-approved medications for alcohol use disorders, and they are certainly not blockbusters when it comes to treating the problem. (See “What Medications Can Help You Get Sober?” and “The Realities of Prescribing and Taking Meds for Alcohol Use Disorders”) In other words, we need more help for a problem that afflicts tens of thousands of people and their family members each year. If we say it’s a “disease” or “disorder,” why would we not treat it like one, denying people medications for their problem?

Brown University professor of medicine, Peter D. Friedmann, M.D., M.P.H. recently stated in Clinical Psychiatry News, “Medicine has long accepted disease-modifying therapies as organ- and lifesaving for other disorders – gold salts and methotrexate for rheumatoid arthritis come to mind. Such remittive agents reduce disease activity without an insistence on complete, total, and lasting cure. These medications are called effective treatment, and are not burdened by the apologist moniker of ‘harm reduction.’ Effective remittive therapies for alcohol dependence such as naltrexone… should not be viewed any differently.”

Certainly abstinence is ideal but it’s unattainable for many people, at least initially. Harm reduction is not about turning “alcoholics” into moderate drinkers. As one commenter nicely put it,

“Harm reduction is not about taking abstinent individuals and encouraging them to resume use. It’s about changing unhealthy, harmful use, to less harmful use. The resulting wellness sometimes motivates individuals that were previously unwilling to attempt abstinence to do so. It’s also about having meaningful, non judgmental, conversations with a wider audience about their drug use and recognizing that self-directed harm reduction is a part of almost every addiction sufferer’s change cycle.”

Is Harm Reduction Becoming a More Acceptable Outcome to Clinicians?

…the late Alan Marlatt, Ph.D. of the University of Washington emphasized that harm reduction shifts ‘the focus away from drug use itself to the consequences or effects of addictive behavior.’

“Harm reduction” typically means meeting people with alcohol and drug problems “where they’re at” and usually includes using less alcohol or fewer drugs as opposed to quitting completely. In addition, early advocate for and expert on harm reduction, the late Alan Marlatt, Ph.D. of the University of Washington emphasized that harm reduction shifts “the focus away from drug use itself to the consequences or effects of addictive behavior.” Thus, it also refers to practices having to do with lowering hazards caused by use, such as offering clean needles to people injecting drugs, getting into fewer fights, engaging in less risky sex, and having fewer mood swings. Explaining that someone who’s not ready to quit using when first seeking help will often choose abstinence after a period of time, Marlatt said, “Moderation is often the pathway to abstinence.”

Although this is not a discussion of returning to or learning how to use substances such as alcohol moderately or socially for a person who once met the criteria for addiction, it’s important to note that this happens more often than most people think and can certainly be an acceptable goal for certain individuals, particularly those with less serious substance problems. Through making better decisions, harm reduction counseling can help them bring about the changes they need to use more sensibly.

(For professional help, consult the Alcohol Harm Reduction Therapist Finder.)

Although this is not a discussion of returning to or learning how to use substances such as alcohol moderately or socially for a person who once met the criteria for addiction, it’s important to note that this happens more often than most people think and can certainly be an acceptable goal for certain individuals… with less serious substance problems.-Anne Fletcher

Views about harm reduction may be changing in more traditional clinical addiction circles as suggested by a 2012 survey of more than 900 National Association of Alcoholism and Drug Addiction Counselors from across the United States in which about half of respondents said it would be acceptable for some of their clients who abused alcohol to limit their drinking but not totally give it up. This is about double the number of treatment program administrators who said this 12 years earlier.

As I traveled around the country visiting treatment facilities while writing Inside Rehab I found some interesting discrepancies between what was said and what was done in some outpatient programs when I asked administrators, “Do you offer any harm reduction approaches for drug and alcohol problems, or is your program strictly abstinence-based?” Some told me that while the program goal “on paper” is abstinence, it’s different in reality. One said, “We preach abstinence but there are times when all we can hope for is harm reduction.” Another said, “To be licensed, we have to say our goal is ‘drug-free,’ but we don’t kick people out if they lapse. To a degree, whatever it takes to get you where you want to be, we’ll work with you.” That is meeting people “where they’re at” and treating addiction like other chronic disorders.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Rehabs.com. We do believe in healthy dialogue on all topics and we welcome the opinions of our professional contributors.

What Are Your Thoughts on this Topic?

  • http://AddictionMyth.com/ AddictionMyth

    Willenbring is a huge disease theory proponent, as is the NIAAA, so it’s funny how he’s now trying to cast himself as a moderate. I would love to hear him renounce this belief once and for all. But he won’t. The reason is that they are pushing pseudoscience propaganda on children and young people that says, “Don’t do drugs/alcohol because it will make you do things you’ll regret and then you might also get the disease of ‘alcoholism’. Just say ‘no’ while you still can. Because maybe one day you won’t be able to.”

    Of course that’s a lie, but it will be harder to scare people into treatment and ‘early intervention’ without the disease bogeyman. The big thing now is ‘campus violence’ in which students who are accused of ‘binge drinking’ can be forced into ‘treatment’ where they learn that it puts them at heightened risk of sexually assault (either as offender or victim) and that it’s a disease and they need to get help before it’s too late. There are hundreds of campus recovery communities across the country that teach alcoholism as a disease and they work hand-in-hand with the treatment propagandists. I seriously doubt Willenbring ever made a serious attempt to change the FDA guidelines, especially considering his previous statements around the time he was in charge that most true alcoholics cannot ever learn to moderate their drinking.

    Alcoholism is not a disease. People drink because they want to and they stop when the want to. Any claim that “I can’t stop no matter how hard I try” is simply a lie.

    • Best_Reviews

      Are you basing what you wrote on personal experience or are basing this on a study?

      I believe that addictive behavior stems from the inability of a person to modify through self-control some behavior that is [not compatible with social norms] that prevents the person from being able to function independently and interfering with their ability to maintain employment, provide room and board for themselves and their children.

      Take me for example. I have been a beer drinker since 16, drinking at least 6 beers every single day for 25 years. I stay away from hard liquor because I know that after 4 drinks, I will start to look for a female who ‘parties’ which will lead to use of hard drugs, expenditures of money beyond budget resulting in missed bill payments, and the cancellation of whatever events were planned for the following day: whether missed work, angry spouse, missed critical medical appointment, failed school exam, inability to pick up [mom/boss/friend] at airport, missed children school recital/broken promises.

      The reason I still have a high paying job requiring a post graduate degree, own a home, an understanding wife and 3+ kids and a guilt free existence is because years ago I stopped trying to completely stop drinking which never worked instead leading each time to a blow to my self esteem, sneaking around, lies, etc. Years ago, I accepted there is nothing wrong with drinking the beer that I love and the soothing after effects since that behavior never resulted in unwanted behavior that I had to feel guilty about, cover up, lie about. So I focused on avoiding drinking whiskey, vodka, tequila, gin or rum – more than 1 shot at any given day.

      That is much, oh so much easier to do than complete abstinence for me. So end result is, I can still enjoy the buzz and the drinking, without having to deal with fundamentally changing my lifestyle while still avoiding behavior that is the slippery slope to losing family, home, friends, job.

      • elain

        It’s great you were successful. Did you have friends helping, or trying to help? Did you have other friends that were the same way? Did they make it too? I hope you take no offense to personal questions and of course I wouldn’t expect you answer if I’m being inappropriate. I hope you do answer because It means something to me

        • Best_Reviews

          I had no friends helping me. Friends from my mid 20s are mostly social drinkers or are pot smokers. Years before I smoked pot when we hung out, but eventually it started making me feel self conscious, paranoid, anti-social and weirded out in a way that I no longer wanted that feeling, so those friends drifted their separate way.

          People from work, a few are drinkers, and we stop at a bar for a few beers. But it never gets to the point of pressure since after an hour- 90 min max, time to commute back. I just turned 40 so not same as it was before.

          But every couple of weeks that little mischievous voice in my head starts whispering about telling the bartender to pour me four shots of tequila and to go on a mission. The excitement of going to a screwed up part of town, dealing with dangerous people again, feeling alive.

          And the disappointment as I head back home on the commute, feeling unsatisfied. But after 30 minutes at home with a punching bag listening to a good hard trance set, kinda sucks those feelings out enough where i don’t pound a bottle of something hard, and jump back on 1 hour return trip to the city, which in the past has happened. Maybe getting older now, who knows.

          I started drinking and doing drugs in last year of high school, and the crowd from those days I lost touch with except with a few on a once a year skype chat. Through the grapevine I know out of 8 people from HS in my circle, 1 died from heroin overdose 3 years after graduation, another 2 are heroin junkies living on street or dead, 1 quit it all and got a phd, one girl also quit and married with children, 1 rehabbed a few times again for heroin and so far 5 years seems to be holding together, another moved overseas married with a kid , seems to be stable, and the others are just gone, nothing on google, nothing anywhere as though they never existed.

          Funny thing is that we were all doing cocaine and weed or acid, no heroin, so I don’t know how all of them turned to heroin. Lying semi-comatose not my cup of tea, always liked energy.

          Hope this answers something of what you asked.

    • Mark Willenbring, MD

      Hi everybody,

      Let me clarify how I see things. (Long post warning!)

      1) Substance Use Disorders (SUD), including Alcohol Use Disorder (AUD) are diseases in every sense of the term. First, they are 50-60% genetic, with environment being an important determinant of whether the genetic vulnerability will be expressed. (Family history is the strongest predictor of whether offsrping will develop AUD. Interestingly, the majority of the vulnerability is shared among several disorders. That is, how it is manifested can go in several ways. Only a minority of the genetic contribution is specific. Anxiety, mood, and addictive disorders, ADHD, and personality disorders share this vulnerability. Second, there are specific neurobiological changes that occur in the brain as a result of exposure to the substance. These changes produce addiction (i.e., impaired control once use starts, preoccupation/craving, compulsive use). These changes are substance-specific; the disorder doesn’t generalize to other drugs. Finally, the reliability of diagnosis is high, and the natural history is similar to that of mental disorders, asthma, etc. That is, highly variable, with many gradations of severity and variability in course, treatment response and outcomes. The best way to think about addiction is that it doesn’t eliminate choice, but it constrains it. It’s a disease involving the brain mechanisms responsible for choice. One of the mottoes of my clinic, Alltyr, is: “We don’t just call addiction a disease, we treat it like one,” i.e., we don’t artificially truncate the length of treatment, as rehabs do. 2) The FDA has only taken a baby step in its new guidance, one that I and many others at NIAAA pushed hard for. They now recognize that both abstinent and non-abstinent recovery occur and have similar prognoses. Non-abstinent recovery is defined as no heavy drinking days (5+ men/4+ women) and not meeting any diagnostic criteria for AUD. I would have preferred that they allow for substantial reductions in drinking (partial remission), but they wouldn’t budge. And we did push as hard as we could. 3) 20 years after onset, about 40% of people with AUD are in non-abstinent recovery. Few, if any ever sought specialty treatment (rehab.) In treatment trials, about 10% maintain non-abstinent recovery throughout the first year, but over time that drops. This is because treatment-seeking is associated with severe AUD, and non-abstinent recovery mostly occurs in mild AUD. The more severe the addiction, the less likely that stable non-abstinent recovery can occur. This is an established fact, not merely an assertion (Refs available) 4) It’s important to distinguish between AUD and medically unsafe drinking in the absence of AUD (at-risk drinkers). Most heavy drinkers do not have AUD, or only have mild AUD, and are able to cut down or stop if they choose to. One early manifestation of AUD is wanting and trying to cut down/stop and being unable to do so (compulsive drinking.) This is a fact, not a lie, and has been demonstrated in numerous other species as well as humans. So for most people going to rehab (the sickest 10%), abstinence is the only option for stable recovery. For many people with mild to moderate AUD, however, moderation may be a reasonable if done right. In order to reach those people, however, we need to offer treatment in a very different way than we do now. At Alltyr, we are indeed seeing many people with no, mild or moderate levels of AUD seeking help because it’s more accessible, affordable and attractive, and treatment is fully individualized and negotiated with each patient, and changes over time depending on results.

      • stapleremover

        Excellent comment. I think you’re on the right track, and I hope we don’t continue to stay bogged down by the ‘disease’ debate or any other things that are just knee jerk reactions to our recognition of the numerous failings of the 12-step model.

      • http://AddictionMyth.com/ AddictionMyth

        Thank you for your response. Treating addiction like a disease is exactly the problem. It’s ok if you’re not yet ready to understand that. It’s a counterintuitive concept and takes a little getting used to. :-)

    • stapleremover

      It’s nowhere near that simple, and to base your entire belief system about recovery on something that is a simplistic, mirror opposite of AA fails to recognize that there are complex medical and scientific elements to addiction that need to be studied and applied. AA fails to address these, let’s not make the same mistake just because we’ve made the right decision to leave AA.

  • annemfletcher

    Too bad you’ve gotten that impression about Dr. Willenbring. I know him well and am now fortunate to be working with him in a harm reduction clinical setting several days a month. I can assure you that he’s not a “disease model proponent” and is very willing to meet patients/clients “where they’re at.” When I interviewed him some time ago for another article on harm reduction he said, that while the ideal for all patients having severe substance use disorders is abstinence, he recognizes that’s not possible for many of them and added, “It’s best to call the way we help them, ‘treatment’ or ‘chronic care management.’ That’s what we do with every other condition or disease.”

    • http://AddictionMyth.com/ AddictionMyth

      My ‘impression’ is based on the following quotes:

      “Dr. Willenbring says studies show that only 5 percent to 10 percent of people who are truly addicted to alcohol can successfully moderate their drinking. That means more than 90 percent fail, including one very public failure: Audrey Kishline.”

      And he defends AA vigorously: “Some have said that AA should have a sexual harassment policy. But what good would a policy do in such a decentralized organization? There’s no one “in charge” of an AA group to enforce it.”

      If he doesn’t believe it’s a disease then let him say it. AA is NOT a “chronic condition or disease” and it harms people to treat it that way.

      • annemfletcher

        Sorry, I misread your first comment. There is a difference between the “disease model” (commonly used at traditional treatment programs) and what you’re calling the “disease theory” – which I assume to mean that “alcoholism” is a “disease.” I meant that Dr. W. doesn’t support the disease model of treatment. You’re right that it would be best for him to give you a response about his stance on the disease theory.

      • elain

        Would you happen to know how we can research Dr. Willenbring’s studies, or if they are his own studies? I really would like to know the steps taken by the truly addicted to reduce harm and attempt moderation For example, I’d like to have a great big study for addicts not successful after several attempts at the only rehab.allowed to them. In patient to start and allowed measured

    • elain

      A rose by another name… Maybe we should try to spread the word to the harm reduction hopefuls, researchers, activists etc. This is another step forward, at least a baby step.

  • Kenneth Anderson

    Mark Willenbring, like all real scientists, modifies his beliefs to fit new data. I find that he is one of the sanest and most balanced voices in the industry. It is all too easy to get entrenched in a battle of “us vs. them,” and it is essential for us to be able to transcend this.

  • massive

    I think we are at a Tipping point. We have Gabrielle Glaser on MSNBC with Chris Hayes, and then we have people like Mariannne Williamson on FACEBOOK saying how dare Gabrielle for talking about alternatives. We get to change what is not working in america, and what is not working is AA, being forced to AA when they get a DUI, leave rehab etc

  • Mark Willenbring, MD

    <3 As Bertrand Russel once said in a debate, “When the facts change, I change my mind. What do you do, sir?”

  • Mark Willenbring, MD

    One other thought. The FDA firmly rejected so-called “harm reduction” (in diabetes or bipolar disorder we call it treatment) as an outcome they would consider meaningful. They only changed the definition of full remission. I think this is misguided. However, we have insufficient evidence yet concerning the stability or effects of reduction that falls short of full remission, at least among people with severe AUD.

  • guestinomicon

    Getting the gov to bless the approach of telling alcoholics that they shouldn’t drink so much is really huge. By telling them to behave themselves and not have more than 4 drinks at a sitting this problem is solved.

    Well done, professionals and government ‘crats.

    While I’m not sure how she became so far-sighted my ex practiced this cutting-edge solution for quite a long and tedious while many years ago. There actually seemed to be a whole slew of these highly prescient people in my immediate drinking area back then. They were so uniform and strident, I imagine that locale could someday become considered the birthplace of the “listen, you just haveta drink LESS, goddammit” approach to the alcoholism problem.

    It’s kind of an honor, really.