02/26/16

Hollow Man Syndrome

25674445_sOn her blog Joanna Moncrieff reflected on a memory she has of a young woman she encountered as a medical student in the 1980s who was confused and frightened when first brought to the hospital. She thought she was being watched and manipulated by evil forces. She believed there was something implanted in her body. Put on an antipsychotic, she became increasingly quiet as the dose was increased. But she also became emotionless, expressionless and physically sluggish. To Joanna, the woman seemed “empty and lifeless compared to what she had been before, although she was less distressed.” This was seen as making her ‘better.’

That reminded me of a young man I knew briefly around the same time who had a psychotic episode, triggered by his heavy use of marijuana. At least, that was his theory. My impression of him after his release from the hospital, where he also began using an antipsychotic, was that his personality had withered; he’d become a hollow man. A few years ago, I met briefly with someone trying to reclaim their thinking ability after taking lithium for over fifteen years. They wanted to cut back on the levels of lithium they were taking. We began working on that plan, but they kept getting caught up in a cognitive eddy of fear that they were going to lose their salvation. Was that psychosis or impaired thinking from the medication?

Another time I was concerned that after a first time manic episode an adolescent would remain on a maintenance dose of an antipsychotic for the rest of his/her life.  Over time I convinced the family to transfer care to a psychiatrist willing to taper the teen off the antipsychotic. The person’s dose was initially halved and symptoms of mania emerged within ten to fourteen days of the initial taper. Was that a suppressed bipolar disorder emerging or was it a reaction to too steep an initial taper? The reaction was viewed by the family as a manifestation of the bipolar disorder that had been kept at bay by a low maintenance dose of the antipsychotic. They decided to stop counseling with me.

These and other experiences have led to the several articles I’ve written on the complications and dangers of antipsychotic medications. Reading the thoughts of psychiatrists like Joanna Moncrieff, Peter Breggin, and David Healy and others on Mad in America over the years had an effect as well. I appreciate the approach of Dr. Moncrieff, who said: “There are times when the use of antipsychotic drugs seems to produce just enough suppression that people can put aside their psychotic preoccupations, and re-establish a connection with the outside world.” Yet she can still see where “they produce an artificial state of neurological restriction,” like a chemical straightjacket.

In my view antipsychotic drugs can be useful in suppressing psychotic symptoms, and sometimes, when people are beset by these symptoms on a continual basis, life on long-term drug treatment, even with all its drawbacks, might be preferable to life without it. But most people who experience a psychotic breakdown recover. [Emphasis added] In this situation, antipsychotics are recommended not on the basis that they provide relief from severe symptoms, but because they are said to reduce the risk of relapse.

The Cochrane Collaboration published a review of antipsychotic maintenance treatment for schizophrenia in 2012. Their report was the first systematic review comparing the effects of all antipsychotic drugs to placebo for maintenance treatment. This is standard care after an acute phase of schizophrenia to prevent relapse. (And it seems, if a teenage manic episode is suspected of being a latent bipolar disorder) Not surprisingly, they found that antipsychotics were more efficacious than placebo in preventing relapse, especially at seven to 12 months. But they noted it was rare to find a study that did follow up longer than 12 months.

Randomised controlled trials (RCTs) since the 1950s have consistently shown that antipsychotic drugs effectively reduce relapses and need for hospitalisation. Conversely, they are, as a group, associated with a number of side effects such as movement disorders, weight gain and sedation.

Moncrieff pointed out two additional problems with these kinds of comparisons. First is the fact that they don’t compare people started on long-term medication treatment and people who were drug free in the placebo groups. Rather, the latter group consists of people who are withdrawn from long-term antipsychotics. Usually the taper or withdrawal occurs too quickly, precipitating discontinuation symptoms, like with the teen I described above. “The difference in relapse rates is almost certainly exaggerated in these studies, therefore, especially since relapse is often defined only in terms of a modest deterioration in general condition or symptoms.”

Another problem is there is typically little data in the studies on anything other than the so-called “relapse,” which is too loosely defined in most studies. So global functioning could be worse for people on continuous drug treatment than they would have been without it, even if they did experience a relapse. “Since the data has not been collected, we just don’t know.”

The first problem perpetuates a distorted message of how antipsychotic medications prevent relapse. The second problem means there is no information on whether someone might be better off if they didn’t use medication.

Moncrieff recently published an article in PLOS Medicine that called for a rethinking of antipsychotic maintenance: “Antipsychotic Maintenance Treatment: Time to Rethink?” Her summary points in the article were:

  • Existing studies of long-term antipsychotic treatment for people with schizophrenia and related conditions are too short and have ignored the impact of discontinuation-related adverse effects.
  • Recent evidence confirms that antipsychotics have a range of serious adverse effects, including reduction of brain volume.
  • The first really long-term follow-up of a randomised trial found that patients with first-episode psychosis who had been allocated to a gradual antipsychotic reduction and discontinuation programme had better functioning at seven-year follow-up than those allocated to maintenance treatment, with no increase in relapse.
  • Further studies with long-term follow-up and a range of outcomes should be conducted on alternatives to antipsychotic maintenance treatment for people with recurrent psychotic conditions.

She described a long-term randomized controlled trial (RCT) by Wunderlink et al. in the Netherlands (in this article as well as in her blog) that confirms how long-term antipsychotic use will impair a person’s ability to function. The study also showed that when you gradually reduce people’s antipsychotics in a supportive manner, they are better off in the long-term.

This study should fundamentally change the way antipsychotics are used. These are not innocuous drugs, and people should be given the opportunity to see if they can manage without them, both during an acute psychotic episode and after recovery from one. If psychiatrists had not forgotten the lessons of the past, and if they had been prepared to acknowledge what they saw the drugs doing with their own eyes, this would have come about long ago.

The studies used to justify current clinical practice don’t provide reliable data on the pros and cons of long-term antipsychotic therapy. More research is needed to evaluate the efficacy of a gradual and individualized approach to antipsychotic discontinuation. Assessment of outcomes in addition to relapse is needed. Moncrieff recommended that while we await the results of further long-term discontinuation studies, that we reconsider antipsychotic maintenance treatment as the default strategy for people with recurrent psychotic disorders.

In “Psychiatric Drug-Induced Chronic Brain Impairment,” Peter Breggin described how chronic brain impairment (CBI) from chronic exposure to psychiatric drugs produces effects similar to those from a traumatic brain injury. He drew a parallel of effects between electroshock treatment, closed head injuries from repeated concussions (like what was portrayed in the movie, Concussion), and long exposure to psychiatric drugs:

The brain and its associated mental processes respond in a very similar fashion to injuries from causes as diverse as electroshock treatment closed head injury from repeated sports-induced concussions or TBI in wartime, chronic abuse of alcohol and street drugs, long-term exposure to psychiatric polydrug treatment, and long-term exposure to particular classes of psychiatric drugs including stimulants, benzodiazepines, lithium and antipsychotic drugs.

He said that by recognizing CBI, clinicians can enhance their ability to identify individuals who need to be withdrawn from long-term psychiatric drug treatment. Most patients show signs of recovery from CBI early in the withdrawal process. “Many patients, especially children and teenagers, will experience complete recovery.” With others, recovery could take place gradually; sometimes over years. Even when recovery is incomplete, Breggin said most patients wish to remain on reduced medication or none at all.

The symptoms of this syndrome include (1) Cognitive deficits, often first noticed as short-term memory dysfunction and impaired new learning, and difficulty with attention and concentration; (2) Apathy, indifference or an overall loss of enjoyment and interest in life activities; (3) Affective dysregulation, including emotional lability, loss of empathy and increased irritability; (4) Anosognosia or a lack of self-awareness about these changes in mental function and behavior.

02/23/16

Emerging Public Health Threat

© imagination | 123f.com

© imagination | 123f.com

I’m almost positive that a guy I saw was high on Flakka. I’d been to Fort Lauderdale Florida for a training conference on relapse prevention. The conference finished early on Friday, so my friend and I decided to catch lunch down by the beach. We were getting a recommendation for lunch from a woman renting Segways, when a man walked by. He was barefoot, shirtless and wearing sweat pants cut off at the knees. He was also busy arguing with someone who wasn’t there. He walked right by us, caught up in his own world.

The reason I suspected he was high on Flakka, was because Fort Lauderdale is in Broward County Florida, which has been ground zero for Flakka. After I commented that I thought the guy was on Flakka, the woman told us that Clearwater was where most of the Flakka problems were at the time. She added that people high on Flakka usually kept to themselves and weren’t violent or aggressive. Then she added that Flakka caused problems because it opened (or activated) the third eye and users were then able to see into the future. We thanked her for her lunch recommendation and left. The guy on Flakka had moved on as well.

We are entering a brave new world of mind-altering substances with NPS—new psychoactive substances—coming to market faster than governments around the world can ban them. See “The New Frontier of Synthetic Drugs” and the “2014 Global Synthetic Drugs Assessment” for more information on the growing problem with NPS. Synthetic cannabinoids (synthetic marijuana), with names like K2 and Spice, are available everywhere. Sold online or in small retail outlets like convenience stores (I’ve heard there’s one that sells it within a mile of my home), synthetic marijuana is popular among younger drug users. After cannabis, synthetic marijuana was the most frequently reported illicit substance used by teenagers in 2012. No longer is finding a pipe in a teenager’s jeans an automatic indication that they are smoking cannabis, the marijuana of their parents’ generation.

The Synthetic Drug Abuse Prevention Act (SDAPT) was signed into law in 2012, but keeping up with the ever-changing chemical formulas used in the manufacturing process is difficult. “The chemical compositions of synthetic drugs are frequently altered in an attempt to avoid government bans.” SDAPT permanently placed 26 types of synthetic cannabinoids and cathinones into Schedule 1. The total number of NPS identified in 2012 was 158.

A CDC report in 2012 said that multiple states found there was an association between synthetic marijuana and unexplained acute kidney injury that was diagnosed after severe nausea, vomiting and flank or abdominal pain brought them to emergency departments. Additional side effects can include tachycardia (faster than normal heart rate) and hypertension.

Synthetic cannabinoid compounds originally were developed to facilitate study of cannabinoid receptor pharmacology, but in recent years have emerged as drugs of abuse. In 2005, SC products marketed as “Spice” first emerged in European countries, before appearing in the United States in 2009, where they were marketed initially as “K2.” Today, SC products are distributed worldwide under countless trade names and packaged in colorful wrappers designed to appeal to teens, young adults, and first-time drug users. Products often are packaged with disingenuous labels such as “not for human consumption” or “incense,” but health professionals and legal authorities are keenly aware that these products are smoked like marijuana. Despite federal and state regulations to prohibit SC sale and distribution, illicit use continues, and reports of illness are increasing.

A 2015 CDC report indicated that poison control centers had 3,572 calls related to synthetic cannabinoid use, which was a 299% increase over the same January-May period in 2014. The number of calls spiked in mid-April before decreasing to 2014 levels by the end of May. The number of reported calls stayed under 100 all throughout 2014. They rapidly increased to 500 calls by April 16th and did not decrease to near 100 until May 28th. See the figure in the 2015 CDC report.

The most commonly reported adverse health effects were: agitation (35.3%), tachycardia (29.0%), drowsiness or lethargy (26.3%), vomiting (16.4%), and confusion (4.2%). Eighty-three percent of the poison center calls had a medical outcome and 11.3% of those had a major adverse event—signs or symptoms that were life threatening or that could in substantial disability or disfigurement. There were 1,407 (47.5%) with a moderate effect—signs or symptoms were not life threatening, and no threat of disability or disfigurement, but did require some form of treatment. “A total of 1,095 (37.0%) had a minor effect (signs or symptoms that are minimally bothersome and generally resolve rapidly with no residual disability or disfigurement).” Fifteen deaths were reported.

This is a fast growing problem and we can’t afford to see it get out of hand. Synthetic cannabinoids were first reported to be in the US in December of 2008 when a shipment of “Spice” was seized by U.S. Customs and Border Protection in Dayton, Ohio. And now, the CDC is saying: “The increasing number of synthetic cannabinoid variants available, higher toxicity of new variants, and the potentially increased use as indicated by calls to poison centers might suggest that synthetic cannabinoids pose an emerging public health threat.”

02/18/16

American Polytheism

© vectomart | 123rf.com

© vectomart | 123rf.com

The Baylor Religion Survey looked “under the hood,” so to speak, of the commonly acknowledged fact of American religiosity. Consistent with other findings, it found that 85-90% of Americans said they believed in God, and 71.5% said they prayed at least once per week. Almost half (49.2%) said they attended church at least once per month. “In fact, under the surface American religion is startlingly complex and diverse. Americans may agree that God exists. They do not agree about what God is like, what God wants for the world, or how God feels about politics.” Let’s see what the Baylor researchers found out.

One of the intriguing aspects of the Baylor Religion Survey was how it assessed religious affiliation. Most surveys simply ask the person to select their affiliation or denomination from a list. But this has become increasingly problematic as more and more Americans lose a strong denominational identity through the rise of nondenominational congregations as well as congregations that minimize their denominational ties. I watched with interest as a large local church completed its building program and shed the “Assembly of God” part of its name to simply become “Church.” Rick Warren’s Saddleback megachurch is similar. How many people realize it is part of the Southern Baptist denomination? I didn’t.

What the Baylor researchers did was look beyond mere denominational affiliation. In addition to the typical checklist of denominations, they asked respondents to give the name and address of their places of worship. This enabled them to more accurately sort persons into broader religious traditions. By their calculations, Evangelical Protestants comprised 33.6% of their survey; Mainline Protestants were 22.1%; Catholics were 21.2%; the Unaffiliated were 10.8%; Other was 4.9%; Black Protestant were 5.0%; and Jewish were 4.9%. See the Survey for further information on these religious traditions.

The so-called “nones,” individuals not affiliated with any religious tradition, have been getting a lot of attention in the reporting on religious surveys lately. The Baylor Religion Survey found that 62.9% of American nones believed in God or some higher power. Most of these individuals (44.5% of the 62.9%) reported a belief in a higher power. There were 37.1% of nones who said they didn’t believe in a God or higher power, while 11.6% believed without any doubts and 6.9% sometimes believed in God or believed with doubts. Almost one third of the unaffiliated (31.6%) reported praying at least occasionally; 10.1% of those prayed daily. What comes to mind is the spiritual, not religious language and distinction made within Twelve Step groups.

Another intriguing aspect of the Baylor Religion Survey was how it used 29 questions about God’s character and behavior to get a sense of what people meant when they said they believed in God. They discovered there were two distinct dimensions of belief in God. The first dimension was God’s level of engagement or activity. This captured the extent to which the individual believed God is directly involved in worldly and personal affairs. The second dimension was God’s level of anger. This described the extent to which the person believed God is angered by human sins and tended towards punishing, severe, and wrathful characteristics.

From these two dimensions, the researchers separated their sample into four types of believers: Type A was the Authoritarian God; Type B was the Benevolent God; Type C was the Distant God; Type C was the Critical God. Type A believers scored above the mean on both the activity and anger dimensions. Type B believers scored above the mean on activity, but below the mean on anger. Type C believers scored above the mean on anger, but below the mean on engagement. Type D believers scored below the mean on both the dimensions. See the following figure taken from the Baylor study:

Baylor

What struck me about this way of assessing belief in God was that it captured more of a sense of how the respondents viewed God, closer to the sense of “God as you understand Him” in Twelve Step recovery. These types don’t neatly fit within a denominational category. You could potentially find all four types within one denomination.

Those who believe in an Authoritarian God represent 32% of the population. They think God is very involved in their lives and world affairs. He is responsible for global events like tsunamis and economic upturns. They also tend to feel God is angry and capable of meting out punishment to those who are unfaithful or ungodly.

Those who believe in a Benevolent God make up 23% of the population. They also see God as very active in their daily lives. But they are less likely to believe God is angry and that He acts in wrathful ways. Instead, they see God as a force of positive influence in the world who is less willing to condemn or punish individuals.

Believers in a Critical God comprise 16% of the population. They feel God does not really interact with the world. However, God still observes the world and views the current stat of affairs unfavorably. His displeasure will be felt in another life and divine justice may not occur in this world

Believers in a Distant God include 24% of the population. They think God is not active in the world; neither is He especially angry. These individuals tend towards thinking about God as a cosmic force, which set the laws of nature in motion, similar to deism. As such, God does not “do” things in the world; nor doe He hold clear opinions about human activities or world events.

When these views of God are used to sort through selected aspects of religiosity, there were some interesting results. Believers who saw God as active in personal and world affairs, (Type A and Type B), were significantly more likely to attend church services weekly, pray several times a day, believe that Jesus was the Son of God, and be biblical literalists.  See the following table derived from Table 8 in the Baylor Religion Survey.

Type A Authoritarian

Type B Benevolent

Type C Critical

Type D Distant

Attends church weekly

50.9%

31.5%

9.8%

7.8%

Never Attends

13.5%

8.2%

16.7%

41.5%

Prays several times daily

54.8%

31.7%

6.5%

7.0%

Never Prays

1.8%

2.5%

18.4%

38.7%

Biblical Literalist

60.8%

26.5%

10.2%

2.5%

Jesus is the Son of God

41.3%

27.8%

14.4%

16.0%

Denominational affiliation is not the whole story on American spiritual and religious practices and beliefs. While the Baylor Religion Survey and other research, such as that by the Pew Research Center, suggest that “nones” are becoming increasingly secular, there clear evidence that many still believe in some kind of a transcendent or higher power and pray at least monthly. The Baylor survey found that around 10% prayed daily. The Types of God used to categorize views of God in the Baylor Religion Survey illuminated an understanding of God that cuts across denominations and has some correspondence with the sense of “God as you understand Him” within the Twelve Steps.

This reflects a growing movement in American religiosity towards what William James described as personal religion in his seminal work, The Varieties of Religious Experience. Institutionally-grounded religious belief and practice is waning, while personal expression of a belief in God and spiritual practices such as prayer continues, even among those who see themselves as not religious. The distinction between institutional and personal religion first articulated by William James in The Varieties of Religious Experience seems to resonate with the modern spiritual, not religious distinction within many Twelve Step groups.

02/16/16

Nearsighted Drug Development

© Antonio Gravante | Dreamstime.com

© Antonio Gravante | Dreamstime.com

I was encouraged to hear that ALKS 5461 failed in two late-stage clinical trial studies. This isn’t because I have something against Alkermes, the pharmaceutical company developing the drug. I don’t own stock in a competing company trying to bring their new fast-acting antidepressant drug to market ahead of Alkermes. I do think antidepressants are overprescribed and have potentially harmful side effects for some people, but that’s not why I was happy to hear that ALKS 5461 is in trouble. I just don’t think that putting an antidepressant drug on the market that uses a potentially addictive opioid as its active ingredient is a good idea.

Reporting for Reuters, Amrutha Penumudi said that when news of the failed clinical trails for ALKS 5461 were made public by Alkermes, the company saw its shares fall in value by 42.8%, a $3.88 billion loss for the company. ALKS 5461 is the company’s main product, so the bad news about the clinical trials was a major financial blow. William Tanner, an analyst for Guggenheim Partners was widely quoted by Reuters and others as saying that “We believe trial failures present a major setback in the evolution of the company.” Even if ALKS 5461 succeeds in a third as-yet not completed clinical trial, more studies may be required, according to Ken Cacciatore.

ALKS 5461 is a new molecular entity (NME) that has been fast tracked by the FDA for approval as a treatment of Major Depressive Disorder (MDD) with patients who didn’t respond to standard antidepressant therapies. It is a combination of buprenorphine, a Schedule IV Controlled Substance and samidorphan, a naloxone-like substance. Suboxone, which is a combination of buprenorphine and naloxone, is commonly used as an opioid substitution medication for heroin and prescription opioid addicts. The major difference between ALKS 5461 and Suboxone as far as buprenorphine is concerned is that ALKS 5461 is currently being tested in 2 mg and .5 mg doses, where standard protocols for Suboxone as an opioid substitution drug could reach 16 mg or higher. You will find more information on ALKS 5461 and my concerns about its use to treat depression in: “The Coming Depression Apocalypse,” an article I published here a few months ago.

But it doesn’t seem Alkermes is going to give up the fight. In their press release, Richard Pops, the CEO of Alkermes said:

We are steadfast in our commitment to developing new medicines for serious CNS conditions where there is a clear and compelling need for new treatment options for patients and their families. . . . Major depressive disorder is one of these conditions. We are building a large body of evidence supporting our belief in the clinical utility and the novel mechanism of action of ALKS 5461. We await the results of FORWARD-5 and will determine our next steps along the regulatory path with those results in hand.

In one of the failed trials, Alkermes did post-hoc analyses (reanalysis of the data after the fact) that indicated the 2 mg dose was more effective than a placebo. Given the results of the two failed studies, Alkermes said they plan to increase the number of patients in the ongoing trial and “update” the planned statistical analysis for FORWARD-5, the third efficacy study in the FORWARD program. The updated analysis sounds like it means they plan to use the same analysis process applied to the 2mg dose group for FORWARD-4 after the fact. This is bit like cheating if the researchers went p-hacking or data-dredging in their post-hoc analysis. See “How to Lie About Research” for more information on p-hacking.

Another factor regarding Alkermes and ALKS 5461 that concerns me is how the company describes the drug. In their above-linked press release, Alkermes said that ALKS 5461 acted “as a balanced neuromodulator in the brain;” and was “designed to rebalance brain function that is dysregulated in the state of depression.” This sounds eerily similar to the chemical imbalance theory of depression that even psychiatrists such as Ronald Pies have said was always a kind of urban legend. In an article in Psychiatric Times, he said: “To my knowledge, no professional psychiatric organization has ever publicly promoted a ‘chemical imbalance theory’ of mental illness in general.” Look at Robert Whitaker’s response to that article by Pies and the reams of additional evidence to show how Pies’ claim was clearly wrong.

But there is now another concern with the use of opioids to treat depression. A study by Scherrer et al., published in the Annals of Family Medicine, found that people who used prescription opioids for longer than a month may have an increased risk of developing depression. Scherrer was quoted by Agata Blaszczak-Boxe for Live Science as saying the researchers rigorously controlled for pain, “and we feel strongly that these results are independent of the known contribution of pain to depression.” The longer individuals were taking opioids, the greater was their risk of depression.

Citing a 2014 study by Howe and Sullivan in General Hospital Psychiatry, Scherrer et al. said that research on the efficacy of opioids in treating depression was limited by small sample sizes, short follow-up time and lack of control groups. So they do not support opioids as effective long-term treatments for depression. “This evidence, combined with the finding from the present study, supports the conclusion that opioids may cause short-term improvement in mood, but long-term use is associated with risk of new-onset depression.”

Buprenorphine was not one of the opioids studied, but the findings of the Scherrer et al. study does give me increased concern with the fast-track status the FDA has given ALKS 5461. Recent findings do suggest the risk of new onset of depression increases with a longer duration of opioid use. A replication attempt of Scherrer’s study with buprenorphine seems needed before approving ALKS 5461. The short-term projected improvements could lead to long-term problems with depression.  “Patients and practitioners should be aware that opioid analgesic use of longer than 30 days imposes risk of new-onset depression.”

Hopefully the FDA will have the foresight to weigh all the potential adverse effects with ALKS 5461 before approving it. There is a very real potential for physical dependency to develop with ALKS 5461 given that its active ingredient is a Schedule IV controlled substance. Heroin addicts have told me buprenorphine was more difficult for them to come off of than heroin or methadone. And to top it all off, there seems to be evidence that using opioids longer than 30 days carries a risk of new-onset depression. This is not a very promising profile for a future treatment for depression.

Additionally, the initial statistical analysis done on the first two clinical trials failed to demonstrate that it was more effective than a placebo. Only after a post hoc analysis was there evidence of any statistically significant results. And then it was only with the higher, 2mg, dose. Will that lead to even higher doses of buprenorphine to increase its effectiveness? Read more on the concerns with outcome switching in clinical trials here.

Revising the statistical analysis (outcome switching) of the remaining clinical trial may produce statistically significant results, and if it does, it seems Alkermes intends to argue with the FDA to approve ALKS 5461. On the one hand, I can see where Alkermes would attempt to salvage their “lead product.” But I’m hoping their nearsighted focus on profits and the company’s market value will not blind the FDA to the long-term consequences of using opioids like buprenorphine to treat depression.

02/12/16

A Double-Edged Drug

© arkela | 123f.com

© arkela | 123f.com

Dee Roberts referred to Suboxone (buprenorphine) maintenance as “withdrawal avoidance” while describing her journey from Vicodin to Suboxone to tapering off of Suboxone. The truth of the statement stung. She said she developed a “deeply rooted” fear of not having the medication with her. Does that sound familiar? Tellingly she said: “My behavior on Suboxone and while using had some alarming similarities.”

In “Kicking Suboxone: The Last Milligram” she described her efforts to break free from what had initially promised her freedom from the Vicodin-vodka cocktail that had stopped working for her. She said she was one of the first to try Suboxone when it became available in 2003. But “not one doctor who saw me suggested I consider going off of the drug. I stayed on it for 10 years until the side effects added up, motivating me to make the final jump.” She spent over $50,000 dollars out of pocket on doctor’s visits and drug co-pays.

If it weren’t for an adrenal imbalance that developed, she thinks she might well have continued taking it for many more years. But that wasn’t her only adverse effect. After a couple of years, she noticed personality changes. She felt like she was watching someone else’s story unfold. She wasn’t able to put words to the experience at the time. “The fighter in me had retired without notice.” She developed a skewed appetite, going from sugar fix to sugar fix. The final straw was when she noticed her hair falling out.

She tried several consultations before she found a doctor willing to help her taper off of buprenorphine (Suboxone). “As if waving a voodoo doll, I was warned multiple times about tempting relapse.” It had been 11 years since her last illicit prescription. She said she found it difficult to separate real withdrawal symptoms from psychosomatic ones in her tapering process. I’d suggest that a better distinction would be between acute withdrawal symptoms (her sense of “real” withdrawal symptoms) and post acute withdrawal symptoms (what she called psychosomatic ones).

Dee’s journey is described in more detail in her original article for The Fix. It involved off-and-on sleep deprivation, bouts of depression, stomach pains, hot and cold flashes, an emotional rollercoaster ride, and the help of a Border Collie mix who became her personal trainer. She had to find her own way out of her withdrawal avoidance disorder, “Since there have been no long-term use studies on Suboxone, side effects are often downplayed or ignored by the medical community.” She referenced a doctor in Boca Raton Florida, Steven Scanlon MD, who wrote a helpful article on “Detoxing from Suboxone.” He said:

 Patients, the first question you need to ask your current Suboxone doctor is whether he has ever taken anyone completely off Suboxone or Subutex.  If he says that he just tapers a patient down after they have been on it long-term and they are fine, then he is disingenuous or at least ill-informed.  If he tells you that he is going to put you on 16mg sublingually for six months while your brain stabilizes and heals and then taper you off it he is purposely or unknowingly misleading you.  How can your brain heal if you are still taking an extremely potent opioid that is classified as a pain medication and approved by the FDA as a medication to treat severe pain? On the other hand, if he tells you about the symptoms I discuss below and has previously helped people get off Suboxone when they are ready, then stick with this doctor and do what he says. When I detox patients off Suboxone I follow them for approximately 5 or 6 months and see them once a week during that time.  I make sure to follow them for at least two months after we stop the Subutex.  I do not use Suboxone, only Subutex, and I will explain why not.

Dawn Roberts suggested that to get a sense of the scope of the problem with recovering addicts who are desperate to get off of Suboxone, type “get off Suboxone” into a search engine. I found over 16,000 results. Then I tried “Suboxone taper” and had over 8,000 results. “Suboxone withdrawal tips” garnered 47,900 results. “Suboxone withdrawal help” had 184,000 hits; and “Suboxone withdrawal symptoms” had 410,000 hits. Writing for The Fix, Roberts investigated why there was no official protocol to detox addicts off Suboxone in “So You Thought You Could Get Off Suboxone?

She provided a brief history of the process that Reckitt Benckiser Pharmaceuticals (RBP) used to bring Suboxone to market and turn it into a blockbuster drug. They spent ten years and millions of dollars to cultivate the buprenorphine formula and another 13 years to bring Suboxone to the market in 2002. They lobbied Congress to create the Drug Addiction and Treatment Act of 2002 (DATA). Then RBP worked with NIDA and the FDA to lay the foundation to introduce Suboxone to the market. Their efforts garnered RBP $1.23 billion in sales in 2011 and $1.35 billion in sales in 2012. According to RBP’s annual report, Suboxone sales were $1.2 billion in 2013, ranking it at #39 of the top 100 drugs prescribed in the US. Oh, and Genetic Engineering & Biotechnology News ranked Suboxone as the second most abused drug of 2013.

Roberts then related how Reckitt Benckiser told her they were not aware of an established guideline or protocol for titration (tapering) off of Suboxone. A RBP spokesperson said:

Patients seeking to discontinue treatment for opioid dependence should be advised to work closely with their healthcare provider on a tapering schedule and should be apprised of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment.

Roberts concluded that RBP outright refuses to study the long-term effects of buprenorphine maintenance. And it seemed that the company was intolerant of buprenorphine patients who decide they want to discontinue Suboxone substitution treatment. I’m beginning to hear a line from the Eagles song, “Hotel California” in my head: “You can check-out any time you like, but you can never leave.”

Guinevere, on Guinevere Gets Sober, a great recovery blog, came to the same conclusion.  In “Suboxone Detox Redux,” she noted that Tim Baxter, the global medical director for RBP, told her: ”We don’t promote detox” from Suboxone. She decided RBP wants you to stay on the drug. Guinevere also recommends Dr. Scanlon’s paper, “Detoxing from Suboxone.” Read her article for good advice if you are considering any attempt to taper or titrate off of buprenorphine.

It seems that RBP has been trying to build a clientele that will continue using their Suboxone products for extended periods of time. Here is an article describing in some detail the gamesmanship of RBP over the years that Suboxone was under patent. RBP lost their exclusivity rights to Suboxone in 2009. However, they submitted a New Drug Application to the FDA for a sublingual film version of Suboxone in October of 2008. It was approved in August of 2010 with patent exclusivity until 2023. In their 2011 annual report, RBP said that competition from generics could take up to 80% of the revenue and profit of the Suboxone tablet business in the US. But they expected “that the Suboxone film will help mitigate the impact.”

Then in September of 2012, RBP announced that they were voluntarily withdrawing the tablet form of Suboxone from the market, citing data they had received from the US Poison Control Centers indicating high rates of pediatric overdose on the tablet formulation. But they were manipulating the market by offering discounts on the sublingual film version while raising the price of the tablets. Hours after announcing their plan to take the tablets off the market, RBP announced they had filed a “citizen’s petition” urging the FDA to require all manufacturers of buprenorphine-containing products to implement safeguards to prevent pediatric exposure, etc. They also asked the FDA to reject any new drug applications for buprenorphine (generic Suboxone) tablets. The FDA didn’t bite and approved generic tablet versions of Suboxone. Janet Woodstock, the Director of the FDA Center for Drug Evaluation and Research, said:

The timing of Reckitt’s September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for this product was expected to begin, cannot be ignored.

Writing for The New York Times, Deborah Sontang published two articles on the pros and cons of Suboxone: “Addiction Treatment With a Dark Side” and “At Clinics, Tumultuous Lives and Turbulent Care.” The doctor running a clinic near Pittsburgh was quoted as saying, “I know on the surface it might look like a pill mill. . . . We’re seeing a fair number of patients, and they’re primarily receiving a prescription.” But he added they encourage, support and don’t judge. “There’s a kind of love.” Read the article to get a clearer picture of his bedside manner. After his “recovery” and entrance into the Suboxone clinic business, Ohio revoked his medical license in 2011 because he had forged signatures verifying his attendance at 12-Step meetings. Pennsylvania suspended his license in 2010 for failing to submit to three unannounced drug tests while he was on vacation.

So getting on Suboxone maintenance is like checking into the Hotel California:

Last thing I remember, I was
Running for the door
I had to find the passage back
To the place I was before
“Relax, ” said the night man,
“We are programmed to receive.
You can check-out any time you like,
But you can never leave!

If you want to hear the entire Eagles song, listen here.

IRETA, the Institute for Research, Education & Training in Addiction, seemed to disparage Sontang’s portrayal of buprenorphine as a “double-edged” drug. They concluded their reflections with the following: “Singling out buprenorphine as ‘the’ double edged drug seems an inaccurate and potentially stigmatizing view of it.”  I’m not buying their rhetoric. From what I’ve seen, buprenorphine really IS a double-edged drug.

02/9/16

Guard Your Heart

© albund | stockfresh.com

© albund | stockfresh.com

John Owen introduced chapter seven of his work, “Of Temptation” by saying he would now address how the heart becomes entangled by temptation. Before this chapter, he had addressed the outward means and occasions of temptation (If you’re interested in reading reflections on those topics, search for other articles with “Owen”). Now he comes to the heart, where temptation will often take advantage of our natural temperament and constitution.

Let him that would not enter into temptation labour to know his own heart, to be acquainted with his own spirit, his natural frame and temper, his lusts and corruptions, his natural, sinful, or spiritual weaknesses, that, finding where his weakness lies, he may be careful to keep at a distance from all occasions of sin.

The person who would guard their heart to avoid temptation has to be acquainted with their own temperament, so they can watch over the deceitfulness that is constantly assailing it. Some temptations grow out of what are the best and noblest parts of our natural temperament, which if it were “well broken up and fallowed,” would see God’s grace take root and grow. “But if it is not watched over, it can be a means of innumerable surprisals and entanglements in temptation.” Then there are other areas of our temperament that are more fruitful ground where envy, malice selfishness and the like can grow. Here the person can scarcely make a move without becoming ensnared in one or the other of them.

He who watches not this thoroughly, who is not exactly skilled in the knowledge of himself, will never be disentangled from one temptation or another all his days.

Just as people can have natural temperaments, which can become a great opportunity for temptation if they are not watched over, so they may have particular lusts or corruptions, which become deeply rooted. This can occur through their natural constitution or by personal experience. Unless the person is mindful of its manifestations, it will be continually entangling and ensnaring them. Uselessness and scandal are continually growing branches on the “root” of unfamiliarity believers have with their natural temperament and constitution. “How few there are who will either study themselves or bear those who would acquaint them with them!”

Be acquainted, then, with thine own heart: though it be deep, search it; though it be dark, inquire into it; though it give all its distempers other names than what are their due, believe it not.

When you know the condition and state of your heart, guard it against the occasions and opportunities that are likely to entangle your nature or provoke you corruption. (Here Owen’s advice echoes the common sense advice in recovery to avoid the people, places and things of addiction.) It may be that there are some circumstances that you cannot avoid, suffer them as best you can through the time of temptation. “Seeing we have so little power over our hearts when once they meet with suitable provocations, we are to keep them asunder, as a man would do fire and the combustible parts of the house wherein he dwells.”

Be sure to stock up on provisions to withstand any approaching storm of temptation. Consider when an enemy seeks to attack a fort or castle. If that enemy finds it well protected and provisioned to withstand a siege, they will move on and not assault it. So shall Satan, if he finds our hearts fortified against his batteries and provided to hold out, will flee from us (James 4:7). The provisions capable of withstanding such an assault are the supplies of the Gospel—“keep the heart full of a sense of the love of God in Christ.” Since we all will be tempted, we should do the following to stay alert for the approach of any temptation.

First, we should always be alert to gain an early discovery of temptation. Many times people don’t see their enemy until they are wounded by it. Often, temptation is not easily discerned. “Few take notice of it until it is too late, and they find themselves entangled.” Watch out for the snares that are laid for you. Understand the advantages may use against you before they gain power and strength; “before they are incorporated with thy lusts, and have distilled poison into thy soul.”

Second, consider the aim of the temptation, whatever it may be. Satan does not aim to have you violate the law; it is not the thing he aims at. His intent lies against your interest in the gospel. “He would make sin but a bridge to get over to a better ground, to assault thee as to thy interest in Christ.” Today he might say, “It’s okay to commit that sin in the name of Christ.” But tomorrow he will condemn you for having done so.

Third, meet your temptation with thoughts of faith concerning the cross of Christ and it will collapse before you. Don’t debate with it. Let your temptation do whatever it will—whether that is doubts about your ability to withstand the sin or fear of its power. “I it is not able to stand before faith lifting up the standard of the cross.”

Now suppose you are surprised by temptation and entangled unawares, so that it is too late to resist the initial entrance of it. What should you do to avoid being carried away by its power? Do as Paul did—beseech God again and again that it would leave you (2 Corinthians 12:8). And if you remain in it, you will certainly either be quickly delivered out of it, or receive sufficient grace not to be utterly foiled by it. Don’t focus your thoughts on the things that tempt you, which could lead to further entanglements. Rather, set yourself against the temptation and pray that it would leave you.

Look to Him who has promised deliverance. Remember that he is faithful and will not let you to be tempted beyond your ability, “but with the temptation he will also provide the way of escape, that you may be able to endure it” (1 Corinthians 10:14). Discover where the temptation that surprised you gained its entrance and speedily close that breach. “Deal with thy soul like a wise physician.” Find out how you were enticed into this situation. If you find negligence or carelessness in keeping watch over yourself, fix you soul there; make up that breach—“and then proceed to the work that lies before thee.”

If you want to read his original work, here is a link to Overcoming Sin and Temptation, a trilogy of three by Owen: “Of the Mortification of Sin in Believers;” “Of Temptation;” and “Indwelling Sin.”

02/5/16

Wolves in Sheep’s Clothing

© Eros Erika | 123rf.com

© Eros Erika | 123rf.com

Atypical antipsychotics are now the largest-selling class of drugs in the U.S., accounting for more than $14.6 billion in annual sales by 2010. They are also the class of psychiatric drugs with the most negative side effects—and that’s saying something when you consider the others, namely antidepressants and anti-anxiety meds. Because schizophrenia effects such a small percentage of the population, the initial market for atypical antipsychotics was limited. The path to increased sales led through finding a wider market than just individuals with schizophrenia. So the pharmaceutical companies began to look at the behavioral disorders.

For the most part, these disorders are less serious than schizophrenia, but many are severe nonetheless, including hyper-activity in children and agitation in elderly patients. Marketing atypical anti-psychotic agents to patients with this broader category of disorders held the promise of sales reaching blockbuster levels.

There were two obstacles to this broader promotion. First, the FDA had only approved atypicals for the treatment of severe psychosis—schizophrenia—in adults. Their use for other disorders was then off-label. FDA regulations prohibit pharmaceutical companies from promoting drugs for such additional uses.

The second obstacle was that they didn’t have a very good safety profile. Used for a serious disorder like schizophrenia, the adverse effects of atypicals were understood to be a trade off. “But the risk–benefit calculus is much less favorable when milder conditions are involved.” Despite these impediments, the temptation was too much for the manufacturers to resist and a number of lawsuits over the past few years attest to this. Read “Antipsychotic Medications Are Spelling Legal Trouble for Drugmakers” for more information on this. Robert Field concluded his article with this observation:

 In light of the large number of successful enforcement actions and the continued potential for abuses, prosecutors are likely to remain vigilant concerning the marketing of atypical antipsychotic agents. Repeated violations could generate even larger penalties. Publicity over the large settlements has put physicians and the public on notice about the hazards of indiscriminate use of this class of drugs. In the future, regulators, clinicians and patients should view atypical antipsychotics and marketing claims concerning them with caution.

Over time, antipsychotics have “evolved.” Some are now approved as adjunct medication for treating major depression. Many are now are also prescribed for the treatment of bipolar disorder. And then there is off-label market for several behavioral disorders. No longer are they relegated to just the niche market of people diagnosed with schizophrenia.

The FDA-approved uses for antipsychotics now include the treatment of bipolar I disorder, schizophrenia, schizoaffective disorder and as an adjunct treatment for major depression. In addition to their FDA approved uses, several atypicals are used off-label to treat various psychiatric conditions. They have been studied as off-label treatment for the following conditions: ADHD, anxiety, dementia in elderly patients, depression, eating disorders, insomnia, OCD, personality disorder, PTSD, substance use disorders, and Tourette’s syndrome.

Clozapine (Clozaril) was the first atypical developed. Introduced in Europe in 1971, it was voluntarily pulled by its manufacturer when it was shown to cause a condition called agranulocytosis, a dangerous decrease in the number of white blood cells. It was then approved by the FDA in 1989 for the treatment of treatment-resistant schizophrenia. In 2002 the FDA also approved clozapine for reducing the risk of suicidal behavior. However, the FDA also requires it to carry five black box warnings for a series of adverse health effects including cardiovascular and respiratory problems and increased mortality in elderly patients with dementia-related psychosis.

The five main atypical antipsychotics currently used in the US are: Aripiprazole (Abilify), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal) and Ziprasidone (Geodon).  There are six newer ones whose off-label use have not been documented or researched as extensively as the preceding five have been. These newer ones are: Asenapine (Saphris), Iloperidone (Fanapt), Lurasidone (Latuda) and Paliperidone (Invega). Two brand new antipsychotics, Rexulti (brexpiprazole) and Vraylar (cariprazine), will be discussed below.

There are also six other atypicals that have not been approved for use in the US. They are: Amisulpride, Blonanserin, Melperone, Sertindole, Sulpride and Zotepine.  The following chart lists the FDA-approved indications for atypical antipsychotics.

Atypicals

Bipolar 1

schizophrenia

schizoaffective

Major depression

Aripiprazole

yes

yes

yes

Olanzapine

yes

yes

yes

Quetiapine

yes

yes

yes

Risperidone

yes

yes

Ziprasidone

yes

yes

Asenapine

yes

yes

Iloperidone

yes

Lurasidone

yes

yes

Paliperidone

yes

yes

Clozapine

yes

yes

Brexpiprazole

yes

yes

Cariprazine

yes

yes

Schizophrenia is the primary disorder for which antipsychotics are targeted and bipolar 1 disorder is second. Three of the main antipsychotics have been approved as augmentations for antidepressants, Aripiprazole, Olanzapine and Quetiapine. Interestingly, the medication guides for most of the antipsychotics seem to downplay the drug class they are in. They only refer to themselves as “antipsychotic” within the warning of a potential side effect called neuroleptic malignant syndrome. Coincidentally, that is the only place the other common term for antipsychotic, neuroleptic, is found.

Here is an example of how the warning for the potential side effect of neuroleptic malignant syndrome: was worded for Seroquel (quetiapine): “neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including SEROQUEL.” Many of the other antipsychotics have similar wording for the discussion of this side effect. Abilify never refers to itself as an antipsychotic or neuroleptic in its medication guide. Under the discussion of possible side effects with Abilify is the following:

 Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These maybe symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.

But you will find a lot of discussion about antidepressants in some of these medication guides. Many of the antipsychotics use language that gives the impression that the drug is an “antidepressant,” not an “antipsychotic.” The medication guides for Abilify (aripiprazole), Seroquel (quetiapine) and Latuda (lurasidone) have an entire section that discusses what someone needs to know about antidepressant medications. Someone not familiar with the various classes of medications who are taking these drugs might think they are taking antidepressant and not an antipsychotic.

The following table summarizes the evidence for off-label use of the five primary atypical antipsychotics currently used in the US are: Aripiprazole, Olanzapine, Quetiapine, Risperidone and Ziprasidone. The strongest evidence of efficacy is noted as “++”, then “+”.  “0” means there have been no clinical trials attempted; “-“ represents no efficacy and “+-“ is for mixed results. “FDA” represents FDA approval for the condition. Keep in mind these ratings are based upon the data from the drug companies in their quest to expand the antipsychotic market.

Disorder

Aripiprazole

Olanzapine

Quetiapine

Risperidone

Ziprasidone

Anxiety

0

++

ADHD

0

0

0

+

0

Dementia

++

+

+

++

0

Depression

FDA

FDA

FDA

++

+

OCD

0

+

++

PTSD

0

+-

+-

++

0

Tourette’s

0

0

0

+

Risperidone was the first of the main five antipsychotics brought to market in 1990 by Janssen. In 1996 Eli Lilly brought olanzapine to market in September of 1996 and AstraZeneca brought quetiapine to market in September of 1997. Pfizer brought ziprasidone to market in June of 2002 and Bristol-Myers Squibb had aripiprazole approved in November of 2002.  All five are currently off patent. The patent expiration dates for the newer antipsychotics are as follows: Asenapine (Saphris) in 2020, Iloperidone (Fanapt) 2027, Lurasidone (Latuda) 2018. Paliperidone (Invega) lost its exclusivity on October 6, 2014.

Two brand new antipsychotics, Rexulti (brexpiprazole) and Vraylar (cariprazine) were just approved by the FDA in the summer of 2015.  Vraylar was approved for the treatment of schizophrenia and bipolar disorder in adults. Rexulti was approved as a treatment for schizophrenia and as an add-on treatment for adults with major depression.

The Rexulti medication guide also has a section describing what you need to know about antidepressants. It has the same warning for the potential side effect of neuroleptic malignant syndrome (NMS) found with Abilify. It also lists major depression as the first disorder it is used to treat; schizophrenia is listed second. So it seems that it is positioning itself to be seen more a treatment for depression than schizophrenia.

To its credit, Vraylar’s medication guide regularly refers to antipsychotics and the side effects of antipsychotics. And I did not find even ONE reference to “antidepressant.” However, its discussion of NMS is subtle, never explicitly saying it could occur from Vraylar. Under warnings and precautions it says:

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

However, truth in advertising isn’t the only concern, at least with Vraylar. Johanna Ryan described a detailed investigation she did of the Vraylar studies registered with ClinicalTrials.gov. Out of the twenty registered studies, seventeen were completed, but still had not shared their results on the government website, a mandatory step in the process. I reviewed all the registered studies for Vraylar on December 4, 2015 and there were still no posted results from the completed clinical trials for Vraylar almost two months after Ryan’s article was posted on davidhealy.org.

She found at least six published papers directly based on these studies; only two were posted on CT.gov. The average number of listed authors was six to eight, with an academic noted as the “lead” author. The rest were drug company employees. Some papers only had employee-authors.

Overwhelmingly they were contract researchers. Some were freestanding clinical trial businesses. Others were busy medical practices with a thriving research business “on the side.” The first recruited subjects largely by TV, newspaper and online advertising which emphasized free treatment. The second combined some advertising with recruitment among their own patients.

The adverse side effects with antidepressants are increasingly evident, as is their well-documented ineffectiveness. But they are more acceptable by our cultural psyche than antipsychotics. Remember Listening to Prozac? Antipsychotics (neuroleptics) are now the “it” class of psychiatric medications. As they expand their market reach to beyond schizophrenia, the term “antipsychotics” has become a liability for sales. “Anti “depression” medication is an easier sell than anti “psychotic.” So it seems there has been an intentional effort by some pharmaceutical companies to blur the lines between the drug classes of antidepressants and antipsychotics.

I think a fitting metaphor for what’s happening is to think of this marketing strategy as an attempt to pass off wolves in sheep’s clothing. But you have to wonder just how bad the adverse effects of antipsychotics  (the wolves) are when the less harmful half of the metaphor—the “sheep”—is antidepressants.

02/2/16

Groundhog Day Recovery

 © Darren Walker | Dreamstime.com

© Darren Walker | Dreamstime.com

In the movie, Groundhog Day, Phil Connors (Bill Murray’s character) is sitting in a bar drinking with two guys, Ralph and Gus. He had just discovered that he is reliving the same day—Groundhog Day—over and over and over again. So Phil asked them: “What would you do if you were stuck in one place? And nothing you did seemed to matter?” Ralph, who was clearly drunk said: That about sums it up for me.” This and other scenes have led me to see the movie as having several allegorical scenes to addiction and recovery.

Later, after they leave the bar with Phil driving, he asked Ralph and Gus what they would do if there was no tomorrow. Gus’s answer was: “That would mean there was no hangover. We could do whatever we want.” This led to a car chase scene that ended with the three of them surrounded by the local police. There is a great moment in the scene, where Phil drove the car onto railroad tracks directly at an oncoming train. He said: “I’m betting he’s going to swerve first.” Again, this is a scene familiar to addicts and alcoholics. Putting yourself in insane situations that end with being arrested.

The hopeless repetition of the same thing over and over is an integral part of the addictive lifestyle as well as the movie. Another scene shows where Phil is trying to convince Andi McDowell’s character, Rita, that he is caught in a repetitive time loop of Groundhog Day. He tells her personal things about herself that Phil Connors, outside of the Groundhog Day time loop, wouldn’t know. Rita wonders how he’s doing this and he tells her: “ I told you. I wake up every day right here … and there’s nothing I can do about it.”

The opportunity to do whatever you want without consequences eventually turned dark for Phil. Like the addict or alcoholic, Phil misperceived what was causing his time loop and tried unsuccessfully to stop it. He said: “There is no way this winter is ever going to end as long as this groundhog keeps seeing his shadow. I don’t see any other way out. He’s got to be stopped. And I have to stop him.”

Phil then stole the groundhog and drove off the edge of a quarry. He took a bath with a toaster. He stepped in front of a car. He dived off of a building. At one point he said: “I have been stabbed, shot, poisoned, frozen, hung electrocuted and burned. . . . and every morning I wake up without a scratch on me, not a dent in the fender… I am an immortal. . . . I killed my self so many time I don’t exist anymore.”

On one of his “dry drunk” days, he sounded like some people who have railed against the perceived hypocrisy of Twelve Steppers. As he gave the introduction to the time of the groundhog’s moment of  “prognostication,” Phil sounded off about his life in Groundhog Day:

This is pitiful. A thousand people freezing their butts off waiting to worship a rat. What a hype. Groundhog Day used to mean something in this town. They used to pull the hog out, and they used to eat it. You’re hypocrites, all of you!

Eventually, Phil started to see that he was powerless to change his circumstances and tried to make the best of them, often without success. He repeatedly caught a kid that fell out of a tree, but the kid always ran away without thanking him. He fed and gave money to a homeless man. He even took him to a local hospital, but the man always died. When a nurse said that sometimes people just die, Phil responded: “Not today.” And yet the man died despite Phil’s best efforts.

He repeatedly attempted to present himself in a way that would spark a romantic interest in Rita, but always ended with her slapping him. Not only was Phil powerless to change his own circumstances, he could not change those of other people—regardless of how much he may have wanted to do so.

Yet he did save Buster, the Groundhog Day emcee, from choking. He saved a young couple from breaking off their engagement And he learned to play the piano. He saw that he could make a difference if he was alert to what happened around him and used the opportunities available to him, as he took his life “one day at a time.” Even with “Needlenose Ned” Ryerson, the insurance salesman who was the bane of his existence during Groundhog Day, Phil was eventually able make it the best day of Ned’s life.

At one point in his efforts to woo Rita, he seems to have surrendered to the fact that he was not God; that he needed to live one day at a time, even if it was within his time loop. He had done an ice sculptor of Rita’s face and she told him that it was beautiful. In response, Phil said: “Whatever happens tomorrow, or for the rest of my life, I’m happy now.”  When he stopped trying to manipulate the circumstances of the time loop, Rita did notice him, returned his affection and the time loop stopped. Here I was reminded of the Third Step: “Made a decision to turn our will and our lives over to the care of God as we understand Him.”

Many of the things in the movie actually do exist within the festivities of Groundhog Day in Punxsutawney. There is a Groundhog Ball. The officials at the ceremony do wear top hats. Phil (the groundhog) supposedly speaks in “Groundhogese” to the president of the Inner Circle, who then translates whether or not he predicted six more weeks of winter. Check the Punxsutawney Groundhog Day Club website for the schedule of events. You can even watch a live webcast of the festivities if you can’t get to Punxsutawney on February 2nd. Oh, and try to see the movie, even if you’re not interested in its parallels to recovery. We all need to learn to live just one day at a time.

(A blog rerun in honor of Groundhog Day)