Wednesday, November 30, 2011

Good Medical Treatment Beats Rehab Any Day

Clinical practice is something of a roller coaster. One day, most of my patients are doing well, the next day, they're all crashing. Today was one of the good ones. Lots of folks doing well. Most doing better than they have in years. Many of my current patients I have picked up in the hospital, doing consultations. Almost all have been through 12-step rehab, most multiple times. The record so far is 43 times! I integrate behavioral treatment (psychotherapy seems to be a bad word in addiction treatment for some reason), medication management, family therapy if needed, and care management. I do this basically by myself (although I do have a couple of great nurses who help with fielding calls from patients and families, medication refills, etc.) Most of the psychotherapy I do takes 20-30 minutes. I try to see patients weekly for awhile and that works really well. Sometimes I've seen patients more often for stabilization but for the most part weekly seems to work well.

One of the first things I do with new patients is to tell them this: "I don't necessarily expect that my patients will never drink again. That is the aspiration [in most cases] and the goal. But clinical experience and scientific research demonstrates that for most patients achieving lasting recovery will take time and repeated efforts. Think of quitting smoking. How many times do most people have to make quit attempts before it sticks? Why would quitting drinking be any different. There is a destructive fiction that when people go to rehab, the clouds part, the light shines through, the angels sing and they never drink (or use) again. This is not typical. The most common outcome of rehab is improvement without remission. "So, if you drink (use) that's when I need to see you the most. Don't stay away because you're afraid I'll be angry or disappointed or because you feel guilty or ashamed. That's like staying away from the doctor when you have an asthma attack because you're afraid she'll be upset that her treatment failed. The goal of treatment is to reduce the frequency and severity of relapses. It will take work and time, and I'll be with you through the process."

Patients become much more engaged in their recovery if they don't fear being blamed for not instantly solving their problems. Finding a solution that works takes time and ingenuity. There is no treatment that always works no matter what anyone tells you. Would you trust a physician who said, "My treatment for breast cancer is 100% effective if you follow my directions?" I wouldn't either.

MW

Sunday, November 27, 2011

Hope for Hospitalized Alcoholics?

A new study found that even severely alcohol addicted patients in the hospital responded to a 20 minute counseling session after leaving the hospital. This has not been found in all studies, however. As is the case with many medical or psychological treatments, some studies are positive, some are negative. In the end, it's the balance. This balance is determined in a synthetic process called systematic reviews and meta-analysis. These are techniques to examine the findings of multiple high quality randomized controlled trials (RCTs) to determine if a treatment is effective overall. I think the jury is still out on this one, but this study had some pretty impressive findings and a reasonably large number of participants. What's more interesting is what happens when you combine a brief counseling session in the hospital with ongoing follow up in an outpatient setting. That's what I am currently doing with the patients I see in the hospital - I start the treatment there and ask them to schedule a follow up in the my clinic. This is what's done in every other medical specialty. Why not addiction medicine? MW Brief interventions in dependent drinkers: a comparative prospective analysis in two hospitals. Cobain K., Owens L., Kolamunnage-Dona R. et al. Request reprint Alcohol and Alcoholism: 2011, 46(4), p. 434–440. In the north of England just a few (and often just one) counselling sessions by a specialist nurse had a remarkable impact on dependent drinkers seeking medical care at an accident and emergency department. Summary Unusually this study in England's north west region assessed the impact of relatively brief advice, not on adult drinkers selected to be at risk from their drinking, but those likely already to be dependent. As with studies of non-dependent drinkers, despite their heavy drinking they were not seeking treatment for drink problems but attending a hospital accident and emergency department for some other reason. Patients whose attendance was thought to be related to drinking were referred for assessment to specialist hospital or research nurses by emergency department triage staff in two hospitals in neighbouring cities. The assessments included the AUDIT questionnaire and for patients who scored as possibly dependent, the Severity of Alcohol Dependence Questionnaire. Patients indicated by both to possibly be at least mildly dependent were asked to join the study. In Liverpool the assessments were done by specialist alcohol nurses who immediately engaged possibly dependent patients in about 20 minutes of advice based on the FRAMES model, prioritising exploration of patients' perceptions of the link between their drinking and their hospital attendance. At the nurses' and patients' discretion, further sessions could be arranged. In practice, of the 100 patients recruited to the study, 46 attended typically four further sessions. In the other hospital in nearby Warrington, the same referral and research recruitment procedures operated, but instead patients were referred to a nurse who was part of the research team who did not offer any alcohol-related advice. Again, 100 patients were recruited at this site to act as a control group against which to benchmark any improvements associated with counselling. At both sites most patients were daily drinkers who consumed on average about 27 UK units (216g) of alcohol a day, tested as severely dependent, and were taking alcohol withdrawal medication. Typically they were single, unemployed white men in their mid-40s suffering from gastrointestinal or cardiovascular complaints. Six months later research nurses were able to reassess about half the patients to evaluate changed in their drinking and drink-related problems since they joined the study. Main findings Six months later the general picture was (despite some reductions) of continued severe drinking and drink-related problems in the control group, but substantial remission among patients who had been counselled by specialist alcohol nurses. The controls were still drinking on average 23 units (184g) of alcohol on nearly six days a week, while counselled patients had cut back to nearly four days a week and eight units (64g). These averages reflected the fact that none of the controls but 39% of the counselled patients had stopped drinking altogether. Also, just 17% of the counselled patients scored as severely dependent on the Severity of Alcohol Dependence Questionnaire compared to 56% of the controls chart. The greater reductions in drinking days and intensity and in scores on the two alcohol problem questionnaires were all highly statistically significant. Not statistically significant but almost so was the difference in the times patients returned to accident and emergency departments – about 90 times among the 50 control patients but only 34 times (or 36 extrapolated to 50 patients) among those counselled. The authors' conclusions The study demonstrates that treatment can be accepted and effective among dependent drinkers who have not come seeking treatment for their drinking. Generally it has not been ethically acceptable to deny treatment to dependent drinkers who are seeking it, complicating the evaluation of whether treatment works. In contrast, because patients were not seeking or expecting treatment, this study was able to compare structured treatment with no specific treatment. It showed that treatment is effective, and that even severely dependent patients can substantially benefit from relatively brief treatment. The patients in this study were usually medically ill; providing alcohol treatment in a general hospital offers a way to reach them even if they do not present to alcohol treatment clinics, and may reduce their need for further medical care. The greater drinking reductions among patients at the hospital offering counselling were due to the greater abstinence rate – 39% v. 0%. It seems likely that their medical conditions would have mandated advice to abstain for 8 in 10 patients and that this was the advice given by the specialist nurses, advice often well responded to. From previous research, it seems likely that planned follow-up counselling augmented the impact of the evaluated intervention. Though striking, the results have emerged from a study in which patients were not randomly allocated and attended different hospitals. On the assessed variables, the patients seemed similar but there may have been remaining differences between them and between how they were treated at the hospitals which contributed to the findings. Moreover, the research nurse who conducted the follow-up assessments was not always 'blinded' to whether patients had been counselled. Despite its general brevity, it is a moot point whether the open-ended treatment could be called a 'brief intervention'. Half the patients could not followed up, potentially biasing the findings. These impressive results are weakened somewhat by the low follow-up rate. But even if we assume bad outcomes (severe alcohol dependence, death or imprisonment) in all patients not followed up, at most 60% of the counselled patients met these fates compared to 88% not counselled. Similarly, assuming continued drinking among patients not re-assessed, the abstinence rate would be 19% among counselled patients but zero among those not counselled. Yet on average these patients drank at least as much as those at specialist alcohol clinics in the UKATT trial in England and Wales, who were seeking treatment and offered what was intended to be a full course of psychosocial therapy in addition to medical treatments like detoxification and anti-relapse medications. In that study, 12 months after starting treatment a minimum of 12% of patients had sustained abstinence over the past three months, compared to 19% at six months (over an unspecified period) in the featured study. Despite its successes, for most patients the intervention was not enough. If abstinence is the yardstick of success, 8 in 10 could not be shown to have achieved it; if not being severely dependent was the yardstick, the corresponding proportion was 6 in 10. Whether more extended or intensive intervention would have been accepted by the patients and helped reduce the failure rate is unclear. The main limitation on delivering it might have been staying in touch with the patients. Few were homeless, yet two letters and two phone calls were unable to recall half for follow-up assessments. As the authors speculated, it could be that the nurses and perhaps ward staff were in a position in most cases to credibly counsel abstinence on medical grounds, helping bolster the results. Few patients were there because of injuries which could be avoided by continuing to drink but taking greater care to avoid getting drunk in dangerous situations. Instead, most seemed to be suffering from chronic conditions which would be aggravated by continued drinking. They were also generally the type of people research suggests are most receptive to abstinence as a goal of treatment and least able to sustain non-problem drinking. Among the issues raised by the study are whether extended treatment is always required before dependent patients – especially those with the disadvantages shared by most of the study's sample – can attain non-dependent drinking or abstinence. Along with other research, it clearly indicates that this is not the case for many patients. More generally, added benefits from longer versus shorter treatments (as opposed to post-treatment aftercare) has yet to be adequately established. Another issue is whether brief interventions will only benefit non-dependent patients. Again this study along with other research strongly suggests this is not always (but sometimes) the case. What makes the difference may be whether the patient makes (or can be led to make) a link between their drinking and the medical misfortune which led them to the emergency department. These issues are explored in greater detail in the background notes. Perhaps the most serious of the limitations acknowledged by the authors is that the hospitals may have differed not just in the availability of specialist alcohol counselling, but in how drinking was addressed by other medical staff. With counsellors available to handle the aftermath, in Liverpool they may have been more willing to expose the need for counselling by assessing and discussing alcohol problems with their patients. A hospital which hosts four specialist alcohol nurses is likely to have a different and perhaps more serious attitude to drinking than one which hosts none. But even if this were the case, it would not affect the strength of the intervention's impact, just relocate a greater part of that intervention to usual medical staff

Tuesday, November 22, 2011

Prometa or Promota? Hope You Didn't Spring for It

A new study just released found that Prometa, a proprietary combination of currently available drugs and nutrients, was no better than placebo in the treatment of methamphetamine addiction. This parallels the negative finding in treatment of alcohol dependence (although most subjects in the alcohol study did worse on Prometa than placebo.) Prometa contains two drugs widely prescribed among people with alcohol dependence, gabapentin (Neurontin) and hydroxyzine (Vistaril.) The third drug, flumezanil, is widely used to reverse the effects of benzodiazepines (such as alprazolam or lorazepam.) However, it can only be given intravenously so it is primarily used to help wake people up after procedures such as colonoscopy where "conscious sedation" is used instead of putting the patient to sleep. The folks at Hythium, Prometa's parent company devised a series of intravenous infusions of these drugs followed by oral medication. They also added various nutrients. Underwritten by wealthy investor Terren Peizer, Hythium hyped Prometa very successfully and in the complete absence of any credible evidence. Prometa is very costly, in the range of $12,000-15,000 or more per month, but enough people addicted to alcohol, methamphetamine or cocaine coughed it up out of desperation, driving the stock very high initially. Those of use who know something about psychopharmacology always knew this was a bunch of horse manure but that doesn't matter much in the addiction treatment world. Prometa wasn't greeted with universal acclaim to say the least. A headline on MSNBC.com in 2007 read: "Unproven meth, cocaine ‘remedy’ hits market. Researchers debate quick fix: Is it good medicine or just marketing?" It took 4 years, but now high quality studies have debunked any claim to efficacy for alcohol or methamphetamine. The meth study, by Ling et al. (Addiction, published online in advance of print, 11/15/11), randomly assigned 120 meth addicts seeking treatment to either the Prometa protocol or a similar set up (with the iv infusions and all) but using placebo instead. As expected, Prometa was no better than placebo. At least it did better in this study than in the study by Anton et al. (J Clin Psychopharmacol 2009;29:334-342,) where for most study subjects, those receiving Prometa had significantly worse outcomes than those receiving placebo! So does this take the wind out of their sales? Of course not! Hythium has the nerve to quote these studies on their website as though they prove than Prometa works, when they show the opposite. That takes real chutzpah. But then again, it's no different than all the treatment centers who offer nutritional supplements, yoga, life coaching, equine therapy etc. as effective for treating addiction. And people keep flocking to them, and paying for them. So until consumers (and payers) wise up, I guess they'll keep selling their snake oil as long as people are buying it.

Tuesday, October 18, 2011

NIH Funding Success Rate at Historic Low

As expected, recent figures release by the National Institutes of Health (NIH) show a dismal 17.4% success rate for scientists applying for research funding. NIH is the largest funder of biomedical research in the world, and has two institutes devoted to addiction: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA.) It's only through NIH supported research that progress is made on understanding addiction and improving treatment outcomes. Yes, we need more access to treatment but we also need better treatments, and that can only come through scientific research. Anyone who care about addiction and its treatment needs to contact their representatives and let them know we support and need research on addiction. Advocacy matters! Why do you think research funding for breast cancer, HIV/AIDS, and autism has gone up so much! Advocacy! Please support research and urge others to as well. MW NIH Grants Funding Drops; The success rate of the government agency’s grant applications has hit an all-time low. By Jef Akst TheScientist.com Oct. 17, 2011 Grant proposals submitted to the National Institutes of Health (NIH) are less likely to be funded than ever before, according to a sneak peak at this year’s success rates obtained by ScienceInsider last week. According to the new estimate put out by the NIH’s Office of Extramural Research (OER), the fiscal year that ended on September 30 saw the funding of just 17.4 percent of research grant applications—a historic low, according to a comment from NIH Director Francis Collins. The numbers are still “preliminary,” and may rebound slightly in the final release of the data next month, OER chief Sally Rockey told ScienceInsider. Still, it’s a significant drop from the 32 percent of grants the agency was funding around the turn of the millennium, and the first time in NIH history that the success rate has dipped below 20 percent. And the drop in grant funding could get even worse: just last month, the Senate approved a 1 percent drop in the NIH budget. If finalized, it would mark only the second time since 1970 that the agency’s budget has gone down instead of up.

Sunday, October 9, 2011

No More Unsupportable Claims!

I had a conversation this past week with another professional who is offering alternatives to 12-step rehab. I had examined his website and had some concerns I wanted to discuss with him. The most important was that on his site, he made claims that I didn't think were scientifically supportable. He claimed, for example, that his program yielded a 70% response (read: cure) rate. So we had a talk. It wasn't easy. I expressed my concern that those of us offering alternatives would be best served by sticking as close as possible to scientifically supportable claims or assertions. I also said that I was concerned that if we acted like current providers in making unsupportable claims that we would hurt our cause. He said that his program is extremely selective in who they take. They accept only "highly motivated" individuals who apparently have little in the way of significant coexisting problems. Among this group, he claimed a 70% rate of success "as the client defined it." He also said some things about accepting only clients with "abuse" rather than "dependence." Finally, he said that a prominent 12-step program had only a 3-5% success rate (compared to his 70%.) Well, as you can imagine, this didn't sit especially well with me. Even with great selection, I have yet to see a credible outcome study demonstrating a 70% rate of remission. Improvement, yes, remission no. Even the worst program in the world is going to have a success rate above 5%, since an evaluation alone yields a success rate of 20-30%. We had a brief discussion about what "abuse" and "dependence" meant in DSM IV (ICD-9 doesn't have an abuse category.) I quoted various studies. None of this mattered. He "respectfully" disagreed. He said he would "take my input under advisement," obviously meaning forget about it as soon as he could get me off the phone. True to form, I received a follow up email saying he'd "appreciated my input" but also that he basically didn't want anything to do with me, since they didn't fit my "model" nor would they be likely to in the future. Since the only "model" I discussed was adhering to scientifically supportable assertions, I have to conclude he decided that no, he didn't want to be held to that standard. In other words, he wanted to say whatever he wanted to, whether it was scientifically supportable or not. What mattered was not the truth, but rather his "model." "Model" and "Philosophy" are two of the most destructive concepts in addiction treatment today. I'll have more to say about this in a future blog. There are so many "programs" out there that provide "miraculous cures" for addiction already. We don't need more. Nutrition therapy, yoga, SPECT scans, yada, yada, yada! Miraculous pharmacotherapy (remember PROMETA anyone?) 12-step programs engage in a more subtle form of this, providing the same treatment over and over again even when it has been proved ineffective. We don't need yet another one. What's needed is straight talk about what we know works, how well (or not) it works, and how best to provide it. We don't need 12-step alternatives that are based on someone's "model" or "philosophy." We need consumer choice based on science and professionalism. The fact is, our treatments for addiction are only partially effective. In many cases they don't work at all. This is how it is in medicine and virtually all other human affairs. Let's face up to this. What's needed is more research, not more unsupportable claims. MW

Tuesday, October 4, 2011

More NIDA Hype: Vaccines for Addictions (NYT, 10/4/11)

The New York Times today published a story about research on vaccines to prevent or treat substance addictions. The tantalizing title: "An Addiction Vaccine, Tantalizingly Close." The problem? It's not only not close, it's looking more and more unlikely as time goes on. The article details the research career of Kim Janda, an immunologist at the Scripps Institute. Unfortunately, his dedicated quest to develop an effective vaccine for nicotine, alcohol, cocaine, methamphetamine or even obesity have all been dead ends. Often, research in rodents is tantalizing but then human studies are inevitably disappointing. Yet, he is said to be at the "vanguard of addiction research." No less a luminary than the inevitably quoted Drug War General and Director of the National Institute on Drug Abuse (NIDA) Nora Volkow naturally endorses this research, which they funded. Ummmhhh. What am I missing here? I wish that this research offered more promise than it appears to, but I'm afraid I see it on the back burner more than the vanguard.

 Dr. Janda commented that because there is so little available to help some of these addicts, people are desperate to hear something that gives them hope. I am sympathetic to the suffering of individuals with addiction and their loved ones, and I understand their desperation. I see it every day in my practice. Indeed as a physician I experience it, having to give them some pretty bad news about the dearth of highly effective treatments for stimulant addictions. (Note: contingency management, where patients are given rewards for staying abstinent and attending sessions is effective at improving engagement and retention. Whether those effects last very long is still unclear. Also high quality cognitive behavior therapy given to better prognosis addicts is beneficial. However, neither of these treatments is available in the community. The 12-step rehab widely available in the community probably has little if any long term effectiveness.) My interpretation is that non-treatment factors (legal sanctions, accumulating adverse consequences, pressure from others, growing up) are more important than treatment of any kind in determining whether a person will stop.

 Just to be clear, none of this is to say that funding basic and clinical research which has not yet yielded much in the way of clinical breakthroughs is not unique to addiction, and not a reason to decrease funding for it. For all of the billions of dollars put into research on treating solid cancers, for example, there is not much to show for it. In many cases, like cancer of the pancreas, brain or lung, there have been no significant advances at all. We still have no effective way to prevent or treat obesity or osteoarthritis. And yes, new treatments in these other areas that offer modest if any net benefit are also touted by a press looking for something big. So this type of thing seems pretty common in a society that looks to technological solutions for problems where changes in policy and regulation would arguably yield more. But I am concerned when the importance of research findings for treating addiction are exaggerated. I think giving hope that something new may become available has its place here as it does in other diseases. But I also think we have to be careful so we don't lose credibility among a public that is not accustomed to looking to science for an answer for addiction since the most widespread treatment is based on a spiritual transformation.

 One more quick note: Dr. Janda also made the unfortunate comment about addicts needing to "want to stop." In my experience, all addicts want to stop because being addicted is so miserable. But breaking up with cocaine is hard to do. Changing behavior of any type is very hard to do. We aren't very good at it, and we are overall pretty poor at helping others change health behavior and maintain the change. It's possible, it happens more often than we might even expect, but when it doesn't happen it's just too easy to blame the victim as "not wanting to change." And it's too scary to realize that sometimes it's impossible to change even when your life depends on it. Just ask the smokers inhaling through their tracheostomy tubes after having treatment for throat cancer. How terrifying is it to watch yourself die of a behavioral disorder that you abhor and despise and want desperately to change?

 MW

Sunday, October 2, 2011

OK, So What's With the Hype About the "Drunk Protector" Drug?

Recently there have been some breathless reports about an experiment conducted by Mark Hutchinson, a scientist at the University of Adelaide, Australia. Hutchinson targeted a novel receptor, TLR4, that is involved in modulating the immune system. It is possible that this receptor is involved in some of the symptoms of drunkenness, like imbalance and slurred speech. Hutchinson gave alcohol to mice who were either normal mice ("wild type") or who had been genetically modified to lack genes encoding two different receptors involved in the TLR4 cascade. They also used a medication that blocked opioid receptors, naltrexone as a comparison group. In addition, they conducted some studies on cell cultures rather than live animals. One of the findings was that mice without these genes had shorter durations of imbalance on two difference measures when given alcohol, compared to mice who were genetically normal. This is what led to the media hype. So does this mean that we are close to a pill that allows people to drink and not get drunk, as media reports suggest? No, of course not. First, this is a very complex experiment that could only be understood by someone steeped in the neurobiology of brain transmission and alcohol's effects on various types of receptors and cells. Second, it has no current or near-term impact. It's meaning only be discerned by other neuroscientists, and it has not even been replicated by another investigator, let alone been translated into a treatment. So, don't get excited, college students! That said, the immune system is something of a trendy thing right now in just about every malady known to humankind, from diabetes to heart disease, stroke to depression. There's no question it is involved in and affected by alcohol consumption. Some effects might be positive, such as a reduced risk of diabetes or Alzheimer's Disease in moderate drinkers, and some might be negative, such liver fibrosis and dysfunctional brain neurotransmission. Here is the website for the original report, for those of you who are undaunted by lots of scientific jargon: http://onlinelibrary.wiley.com/doi/10.1111/j.1476-5381.2011.01572.x/pdf MW