07/28/17

The Open Secret of K2 in Prisons

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Early Wednesday morning on April 19, 2017, Aaron Hernandez was found dead in his prison cell. He hung himself by wrapping a bed sheet around his neck and tying it to a bar on the window of his cell. The former tight end for the New England Patriots was found guilty of first-degree murder in 2015 and was sentenced to serve life in prison without the possibility of parole. Investigators suggested Hernandez killed Odin Lloyd because he didn’t want information about his bisexuality to become public knowledge. He had slicked the floor of his cell with liquid soap, probably in case he lost his nerve in the midst of his suicide attempt.

While the eternal spiritual state of his soul can’t be known with any certainty, what is known for sure is there was K2, a form of synthetic marijuana, in him when he died. Writing for Newsweek, Michelle McPhee reported Hernandez had a Bible open to John 3:16 in his cell and had scrawled the verse in red ink on his forehead. He also made red ink marks on his hands and feet, mimicking the stigmata of the crucifixion of Christ. He wrote three notes—one to his fiancée, the mother of his daughter, one to his daughter and one to a man identified as his prison boyfriend.

In a second article, McPhee said verifying the presence of K2 in Hernandez’s system led to a State Police raid at the Souza Baronwski Correctional Center (SBCC), the prison facility where Hernandez died. Department of Correction sources confirmed a wide-scale investigation was underway at the prison, as well as a warehouse used to store dry goods before they went into the prison. But this is not just freak occurrence within a single Massachusetts state prison. Aaron Hernandez’s tragic death spotlighted a serious problem with synthetic marijuana in prisons.

Writing for The Fix on April 19th, Seth Ferranti described how the U.S. Bureau of Prisons (BOP) has a synthetic marijuana problem. The problem is twofold. First, the BOP doesn’t regularly test for synthetic marijuana. Prisoners are tested for illicit drugs such as heroin and marijuana, but the standard urines tests don’t screen for the metabolites from synthetic marijuana. However, there is technology available to test for synthetic marijuana. Google “synthetic marijuana urine tests.” You can even order the kits through Amazon.

Second, if an inmate is caught with synthetic marijuana, it is a relatively minor offense—a 300 series incident report—equivalent to illicit tobacco possession. Possession of illicit drugs like heroin or marijuana or a positive urine test for those substances is a series 100 offense, the most serious incident report. A series 100 offense could result in 60 days in Disciplinary Segregation (the hole), or the loss of good time, commissary, or visiting and phone privileges for up to one year. The punishment for synthetic marijuana is essentially a slap on the wrist. “By switching their illicit smuggling ventures to K2 or Spice they’re lessening the consequences that they’ll face when caught.”

The Federal Correction Institution (FCI) in Forrest City Arkansas was given as an example. A prisoner said after the 9:30 pm count, the bathrooms and shower stalls fill up with prisoners smoking some version of K2 or Spice. It can be hard to find an open shower stall to take a shower. On the recreation yard at dusk, clouds of smoke appear over the bleachers from all the people smoking K2. “With endless amounts of time and little fear of consequences, inmates are smoking nonstop.”

The effects of synthetic marijuana on an individual can vary widely.  One man began to dance around like a ballerina. As guards tried to subdue him, he resisted yelling that it was their fault. “You let it in, you bring it in. It’s all a conspiracy to get everyone to tell on each other.” Another person started hugging his bunk, while “screaming like a banshee.” When other prisoners tried to quiet him, it only became worse.

I talked to one dude and he said he hit it and he started rapping. He told me he never rapped in his life, but that was all he could do to not lose his mind. Then another dude smoked some and crawled under the bunk. When we got locked down this guy went totally … crazy. He kicked a C/O and went absolutely insane, screaming and running, all kinds of crazy shit. Another guy thought he was God and that the end of the world was coming, slobbering and acting like a five year old. It’s all bad man.

Smuggling K2 into prisons is done by a variety of methods, but visitation is the primary method. Guards will smuggle K2 in, seeing it as a lesser evil and as a way to make some easy money. The main way it came into Forrest City was over the fences, which are low. “Campers or free world people throw packages over the recreation yard fence.” At FCI Beckley in West Virginia the regulr smuggling gauntlet is through the mailroom. K2 begins as a liquid that can be sprayed on any kind of paper product, like letters. Inmates then smoke or ingest pieces of the soaked paper, or sell it to other inmates. Chris said: “It’s becoming an issue at every institution. It’s crazy here.”

While U.S. media coverage of this problem was scarce before Hernandez’s death, it has been regularly noted as a concern in U.K. prisons for several years. In October of 2015, BBC News reported how investigators concluded the use of Spice in an Oxfordshire prison contributed to an increase in violence. A November 2106 article in The Daily Mail described a documentary, the “Secret Life of Prisons,” that said drugs (particularly Spice) are widely available. The drugs are smuggled in with drones, hidden in trainers, and even on children’s drawings.

A Vice article on January 29, 2016, reported how prison officers said they are getting involuntary hallucinations after entering cells where inmates had recently smoked Spice (it’s odorless). Another BBC News article reported officers at HMP Holme House complained of feeling dizzy after entering cells where inmates had smoked Spice. One officer they believe was exposed had a fierce burning sensation in his head, “which felt like his head was covered with nits, and [he] spent the night tearing at the top of his head.” One former inmate said he’s seen men go berserk, turning on their best friends. “I’ve also seen it where lads have dropped down dead, had heart attacks, gone into comas, gone loopy and ended up being sectioned because of it.”

An April 19, 2017 article on Devon Live described the problem with synthetic marijuana at another British prison, HMP Dartmoor. Here, like the U.S. prison in Forest City Arkansas, the drugs mostly come into the prison is as “throwovers” tossed over the prison wall. An ex-offenders’ organization called User Voice surveyed nine jails on their use of Spice. One third reported using Spice in the previous month. User Voice said the use and popularity of Spice contributed to an increase of violence, bullying, mental and physical ill health concerns, and even death within British prisons.

Writing for the Pittsburgh Post-Gazette, Rich Lord described the K2 problem at the Pennsylvania State Correctional Institution – Huntingdon. Inmates have written to the Post-Gazette, saying they don’t like seeing their neighbor passed out from the drugs they buy in the prison yard. A member of the security team at the prison said these guys who use K2 are often zombie-like: “They’re just groaning, moaning and not able to understand anything that’s being said to them.” SCI Huntingdon first noticed K2 about eighteen months ago.

When an inmate’s belongings test positive for K2, he typically gets 90 days in restricted housing, meaning he spends 23 hours a day locked in a Spartan cell. The restricted housing unit at Huntingdon is largely filled with prisoners whose belongings tested positive for K2. Some inmates claim they were wrongly identified as having K2. One prisoner wrote how he received a misconduct report accusing him of having K2 in a bottle he said held only shampoo. The misconduct could stymie his bid for boot camp and early parole. He said: “I’ve made mistakes, but I don’t deserve this.”

There is regular reporting on the growing presence of K2, Spice and other new psychoactive substances in the U.S. So the apparent silence on the extensive the use of synthetic marijuana use in U.S. prisons is curious to me. It was encouraging to see the coverage given to it by the Pittsburgh Post-Gazette. But it seems the methods used to uncover K2 use need to be more accurate, as the negative consequences to inmates for false positives are so serious. The ready availability of these substances in prisons seems to be an open secret—we know they are in there, but just don’t want to think about it.

See other articles on new psychoactive substances (NPS) on this website such as: “Not Meant for Human Consumption.”

07/25/17

Keep on Knocking

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The first sentence for the Step Eleven essay in Twelve Steps and Twelve Traditions succinctly says: “Prayer and meditation are our principle means of conscious contact with God.” Bill W. went on to say there were some who recoiled from meditation and prayer “as obstinately as the scientist who refused to perform a certain experiment lest it prove his pet theory wrong.” Yet for those who made regular use of prayer come to see it as necessary for their survival as air, food or sunshine: “We all need the light of God’s reality, the nourishment of His strength, and the atmosphere of His grace.”

“Ask, and it will be given to you; seek, and you will find; knock, and it will be opened to you. For everyone who asks receives, and the one who seeks finds, and to the one who knocks it will be opened. Or which one of you, if his son asks him for bread, will give him a stone? Or if he asks for a fish, will give him a serpent? If you then, who are evil, know how to give good gifts to your children, how much more will your Father who is in heaven give good things to those who ask him! (Matthew 7:7-11)

In verse 7, there are a series of commands: ask, seek and knock. All three are in the present tense, which suggests we are to persist when we come to God in prayer. We should petition God “with an expectant attitude,” according to Craig Blomberg. In verse eight, we have a repetition of what to expect when we pray: all who ask receive; everyone who seeks something will find it; when someone knocks on a closed door, it will be opened. But it would be a mistake to use this as a kind of incantation with which we can petition and receive from God whatever we desire.

Bill W. astutely noted that when we ask for specific solutions to specific problems, and for the ability to help other people as we think they need to be helped, “We are asking God to do it our way.” We should consider each request carefully to see its real merit. His advice when making specific requests was to add a qualification: “ . . . if it be Thy will.”

We discover that we do receive guidance for our lives to just about the extent that we stop making demands upon God to give it to us on order and on our terms.

Not too long before this passage in Matthew was Jesus’ counsel to not pray like the hypocrites or use empty phrases (Matthew 6:5-15). Instead, we should pray humbly to our Father in Heaven, asking for His will to be done; for our daily bread (needs); for our debts to be forgiven; and to keep us from temptation. This passage, of course, was on the Lord’s Prayer. So when we self consciously acknowledge God as our Father in heaven, and seek for his will to be done on earth as it is in heaven, we can trust that He will provide for our needs. So we can confidently, ask, seek and knock. And when we ask according to His will we will receive; we will find what we seek; we will open what was closed to us when we knock.

The rhetorical questions in Matthew 6:9-10 imply a negative answer: of course a human father would not be so obtuse when responding to the requests of his son. He would not give a stone when asked for bread or a serpent when asked for a fish. Bread and fish would have been common foods for the people listening to Jesus give the Sermon on the Mount, again pointing back to relying upon God for our daily needs.

There is also a possible allusion to a sense of trickery—bread can be shaped to look like a stone; snakes can be mistaken for a certain eel-like fish catfish in the Sea of Galilee.  If a human father can be trusted to give good things to his son, can’t we place even greater trust in God the Father? Jesus is reasoning from the lesser to the greater here. If such trickery or obtuseness would be unthinkable in a human father, “how much more” can our heavenly Father be trusted?

So the lesson of the passage is that we can trust God to answer our prayers. When we ask according to His will, we will receive. When we seek our daily needs, we will find them. And when a door appears closed to what we ask or seek, if we knock it will be opened for us. Here the call is for hope and perseverance. We are to continue asking, seeking and knocking until the seemingly closed door to us is opened, because we can trust God to meet our needs.

This call for persistence in prayer also applies to those who have tried to give up drugs and alcohol but failed repeatedly. There is a sense of dread that overcomes the person who has made repeated attempts to stay abstinent and failed. They begin to think there is no hope for them; that they are “constitutionally incapable of recovery.” This is a mistaken belief about recovery and relapse. In his booklet Mistaken Beliefs About Relapse, Terence Gorski said: “A mistaken belief is something that you believe is true and act as if it were true when, in fact, it is false.”

Continue trying to establish and maintain abstinence. Ask for guidance; seek help; keep on knocking (persist in asking and seeking) until you obtain it.  Because you won’t be tricked or be given something that won’t meet you needs (a stone or snake).

This is part of a series of reflections dedicated to the memory of Audrey Conn, whose questions reminded me of my intention to look at the various ways the Sermon on the Mount applies to Alcoholics Anonymous and recovery. If you’re interested in more, look under the category link “Sermon on the Mount.”

07/21/17

Blind Spots with Antipsychotics, Part 2

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The American Journal of Psychiatry published an article by Goff et al. that addressed concerns that antipsychotic medications can adversely effect long-term outcomes of people with schizophrenia. Their conclusion was that there was little evidence to support “a negative long-term effect of initial or maintenance antipsychotic treatment on outcomes,” when compared to withholding medication treatment. Additionally, the researchers said while a subgroup of patients may benefit from “nonpharmacological treatment approaches,” they warned of the potential for an “incremental risk of relapse” and recommended the need for further research into the question. But did these researchers have a blind spot in how they evaluated their evidence?

In part one of this article, I reviewed some of the research evidence that supported concerns with long-term antipsychotic treatment. There was evidence supporting a link between long-term antipsychotic use and adverse cardiovascular events, brain shrinkage, and dopamine supersensitivity, as well as questions regarding the efficacy of antipsychotic maintenance treatment. There also seemed to be a disregard in Goff et al. of the evidence for the risk of metabolic syndrome with long-term antipsychotic use in their risk-benefit analysis of antipsychotic use. Yet health concerns from metabolic syndrome have been connected to the glaring difference in a shortened life expectancy, with persons suffering with serious mental illness dying 25 years earlier than the general population.

My previous encounters with Dr. Jeffrey Lieberman, who was the lead researcher for Goff et al., have led me to be cautious of his assertions without further investigation. I believe he has a serious blind spot when it comes to assessing and interpreting information counter to his position. See (“A Censored Story of Psychiatry, “Part 1, Part 2;  “Psychiatry, Diagnose Thyself!” Part 1, Part 2) for more on my concerns with Dr. Lieberman. So if there was a blind spot in Goff et al., what do other experts have to say about their conclusions?

Joanna Moncrieff wrote a response to Goff et al. on the Mad in America website, which can be accessed here. Moncrieff is a practicing psychiatrist, academic and author. She is one of the founding members and current co-chair person for the Critical Psychiatry Network, “a group of psychiatrists from around the world who are sceptical of the idea that mental disorders are simply brain diseases and of the dominance of the pharmaceutical industry.” She has written extensively on this issue, including a recent book on the troubling story of antipsychotic drugs entitled: The Bitterest Pill. You can read more about her thinking and her background on her website. She said she was shocked by how Goff et al. dismissed the concerns with long-term antipsychotic treatment and the evidence of brain impacts.

It is riddled with distortion, ignores the most pressing criticisms, and is shot through with the unexamined presumption that the multitude of problems currently labelled as schizophrenia or psychosis will one day be revealed to be due to a specific brain abnormality that is targeted by antipsychotics.

She doesn’t dispute the usefulness of antipsychotics for treating acute psychosis, what Goff et al. called initial antipsychotic treatment. Yet she noted where “decades of research into early intervention has not demonstrated that early antipsychotic treatment improves long-term outcomes.” She pointed out where Goff et al. stated the effectiveness of maintenance treatment has been well established, but then failed to acknowledge that randomised trials of maintenance treatment were typically maintenance treatment versus sudden withdrawal. “Thus they completely fail to address concerns that effects of withdrawal of long-term treatment inevitably confound such studies.”

The most worrying thing about the Goff et al. paper to Moncrieff was the minimization of the evidence that antipsychotics produce brain shrinkage. They claim that shrinkage of brain grey matter has been shown to be part of schizophrenia, claiming that brain differences were detected long before the introduction of antipsychotics. The paper they cited was a 1985 study by Bogerts and Schonfeldt-Bausch, which was a post mortem study done long after antipsychotics had been introduced.

The presence of differences between the brains of people with schizophrenia and controls does not establish that there is progression of brain volume loss, which is what has been clearly demonstrated in people and animals taking antipsychotics. There are no studies that show progressive brain changes in people diagnosed with schizophrenia or psychosis in the absence of antipsychotic treatment.

Dr. Moncrieff concluded her article by saying:

I still think antipsychotics can be useful, and that the benefits of treatment can sometimes outweigh the disadvantages, even in the long-term for some people. However, it does no one any service to pretend that they are innocuous substances that somehow magically transform (hypothetically) abnormal schizophrenic brains back to normal. Psychiatrists need to be fully aware of the detrimental effects of antipsychotics on the brain and body. They also need to acknowledge the way these drugs make life so miserable for many people, even for some who might have been even more distressed were they to be without them… Psychiatrists need to support people to evaluate the pros and cons of antipsychotic treatment for themselves and to keep doing this as they progress through different stages of their problems. To do this they need to be able to acknowledge the real nature of these drugs, and not sweep inconvenient truths under the carpet!

Miram Larsen-Barr also wrote a response to Goff et al. that appeared on Mad in America, which can be accessed here. She is a clinical psychologist with the University of Auckland, New Zealand. Larsen-Barr created and is the Service Director for Engage Aotearoa, an initiative that aims to make recovery information more easily accessible to the general public. She has “lived experience” of recovery from trauma, depression and suicidality. Her doctoral research explored experiences of taking, and attempting to stop, antipsychotic medication.

For her doctoral research she talked to 144 people who take or have taken antipsychotics. One-third thought antipsychotics had relieved their symptoms and given them back their lives—but another third said quite the opposite. She said the claim that the benefits of antipsychotic medications conclusively outweigh the adverse effects is just not true. It is true for some; entirely the opposite for others; and a mixed bag for the remaining individuals. You can access a copy of her thesis research here.

In my study, overall subjective experiences ranged on a continuum from life-saver” to hell” and every point between (Larsen-Barr, 2016). Around a third reported overall positive experiences such as A major relief from the monsters […] for me they have saved my life” and Helped me get through an unstable period of my life. And around a third of the participants reported mixed experiences such as, A short term help when needed then a burden” and A double edged sword. They help me with my bad experiences but they also take away the wind in my sails.”Another third reported wholly negative experiences such as, The worst experience of my life […] affected every aspect of my health and wellbeing. The therapeutic benefits certainly did not outweigh the costs for those who described the overall experience of taking antipsychotics as The ruin of my life or said they were Helpful to a point but […] robbed me of everything I value in myself as a person.

Larsen-Barr reported that few people in her study reported being well-informed of the potential benefits and risks before antipsychotic treatment. While about one-third reported beneficial results, 79% overall did contemplate stopping their medication, with 73% making at least one attempt. She said her study suggested the desire to stop antipsychotic medications was not just because of negative experiences. These decisions were primarily based upon whether or not taking AMs helped the person to “function in daily life.”

A full third of her survey sample had discontinued medications at the time of the study, which was similar to the stable discontinuation rate found in Harrow’s long-term study. Larsen-Barr found half of 105 survey participants who attempted to stop remained AM-free for one year or more; some over five years ago. Her research showed “withdrawal often entails a lack of information, poor support, and a range of physical, emotional, cognitive, social and functional disruptions that can be difficult to cope with, and which may include exacerbation of symptoms to the point of relapse.” For more on the Harrow study and concerns with antipsychotics, see “The Case Against Antipsychotics” by Robert Whitaker and “Worse Results with Psych Meds” on this website.

In part 1 of this article there was a discussion of how Carrie Fisher’s sudden cardiac death may have been associated with her use of psychiatric medications. Yet the possibility of her medications being a contributing factor to her death seemed to be overlooked in many articles about her unexpected death. For example, writing for Scientific American, Tori Rodriguez raised the possibility that Fisher’s bipolar disorder played a role in her death. Not the medication used to treat her bipolar disorder, but the disorder itself.

Did Carrie Fisher’s Bipolar Disorder Contribute to Her Death?” noted several possible connections to her bipolar disorder, but only made an oblique comment about how the medications may cause adverse effects like weight gain, diabetes higher triglycerides and even sudden cardiac death. Rodriguez noted how Fisher’s earlier substance abuse and struggles with her weight have been speculatively raised as contributing factors to her death. But she said one possibility that has been overlooked was the connection between bipolar disorder and cardiovascular disease and mortality. Individuals with bipolar disorder are twice as likely to develop or die from cardiovascular disease. The onset of cardiovascular disease occurs up to 17 years earlier in persons with bipolar disorder than in the general population. But as we’ve seen, that connection seems to be with the medications and not the disorder itself.

Rodriguez said Carrie Fisher “fit the bill” for several of the risk factors for sudden cardiac death at different points in her life. Then she said: ‘There is no definitive way to know whether her bipolar disorder or addiction history contributed to her death.” Yet there does seem to be a strong likelihood that not only did her use of antipsychotic medications help her be a better mother, friend and daughter, it may have contributed to her sudden cardiac death as well.

07/18/17

Opana Cold Turkey

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On June 8, 2017, the FDA did something it had never done before. It formally requested that a pharmaceutical company voluntary remove its opioid pain medication from the market. The company was Endo Pharmaceuticals and the opioid was Opana ER. “Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval.” Way to go FDA.

The FDA decision was based on a review of post marketing data, which showed a drastic shift in the route of Opana ER abuse after the drug was reformulated in 2012. This review demonstrated that instead of crushing and snorting Opanas, individuals abusing the drug were now dissolving and injecting it. The FDA’s decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that “the benefits of reformulated Opana ER no longer outweigh its risks.” The newly appointed FDA Commissioner, Scott Gottlieb said:

We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse. . . . We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.

The NPR program, All Things Considered, interviewed Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research about the decision on June 9th. She said the decision was made due to the risks of abusing the product. An outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy), were associated with individuals injecting the reformulated Opana ER. The request to remove Opana ER from the market is not an outright ban. When asked what the response from Endo Pharmaceutials has been, Dr. Woodcock said the company is evaluating the request.

Well, FDA does not have the authority for drugs to immediately remove them from the market. Generally we ask companies to voluntarily pull their drug off the market. If they are not willing to do that, we will issue a notice of a hearing, and we have to go through a judicial type of process.

Another NPR report on April 1, of 2016 said that the reformulation in 2012 effectively stopped people from snorting Opana, which had been the preferred method of abuse. “But the change also led a significant number of people to abuse the drug by injection.” Endo said the company’s decision to reformulate Opana was “a well-intentioned attempt to prevent abuse.” But there seems to have been an additional motivation for the action. According to NPR, “interviews with experts, court filings, documents from the FDA, as well as Endo’s own statements, suggest the company’s decision to reformulate Opana was also motivated in large part by financial interests.”

Soon after its release in 2006, there were reports of abuse and overdose deaths with Opana from around the country. But the painkiller was a major moneymaker for the company. It accounted for 14% of Endo’s total revenue; $384 million in net sales in 2011. In late 2011 the FDA approved Endo’s reformulated version of Opana and Endo began replacing the old version of Opana in pharmacies. That August, Endo filed a petition with the FDA (available in the NPR article), arguing that it removed the crushable version of Opana because it was a safety hazard. It also asked that the FDA refuse or withdraw the approval of generic versions of Opana because they were not crush-resistant.

In 2012 Endo filed a lawsuit to compel the FDA to speed up its review of their petition, predicting a spike of misuse and abuse if generic, crush-resistant versions of Opana went to market. It also estimated that if a generic version went to market, “annualized net sales will decrease by an amount up to $135 million.”

This was nothing new. In 2010 Purdue Pharmaceuticals reformulated OxyContin to make it crush resistant. And the FDA determined the reformulated version was much safer and that the benefits of the original no longer outweighed the risks. The agency blocked generic versions of OxyContin, which made Purdue billions. Dr. Anna Lembke, an assistant professor of psychiatry at Stanford University Medical Center said: “We see this again and again in the pharmaceutical industry. . . . They come up with some new fancy formulation of basically the same old drug … and then that way they have a new drug that they can charge a lot of money for.”

But on May 10, 2013, the FDA decided Endo’s tamper-resistant formula didn’t actually prevent drug abuse better than earlier versions of Opana without the abuse-deterrent feature. That day the price of Endo shares dropped more than 5 percent. The FDA said the reformulated version could be compromised when it was subjected to “cutting, grinding and chewing.” It could be “readily prepared for injection.” The agency also warned the preliminary data suggested the possibility “that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.”

The FDA said Endo could not refer to Opana ER as “abuse deterrent.” Writing for FiercePharma, Emily Wasserman quoted Douglas Throckmorton, a deputy director for the FDA’s Center for Drug Evaluation and Research, as saying: “We think the public health would not be served if a company can market itself as ‘abuse deterrent,’ if the scientific evidence did not support that claim.” The problems with Opana seemed to put the FDA on alert that abuse-deterrent technology may not be all that effective. An FDA spokesperson, Sarah Peddicord said: “The FDA is very concerned about potential unintended consequences of abuse-deterrent opioids (and purportedly abuse-deterrent opioids) and it is something we are actively looking at.”

FDA is requiring all sponsors of opioids with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in the real world. . . . Abuse-deterrent does not mean abuse-proof.

So while the June 8th request by the FDA may be unprecedented, it seems to have been coming for a few years. Then a week after the FDA request, Scott Gottlieb ordered a review of all opioid pain relievers with abuse-deterrent formulas to see if they actually help prevent abuse and addiction. In a statement released on June 13th, Gottlieb said there would be a public meeting to discuss whether they have the right information to determine if the abuse-deterrent products “are having their intended impact on limiting abuse and helping to curb the epidemic.”

The FDA, he said, recognizes there is a gap in their understanding of whether these products have a real-world, meaningful effect on opioid misuse and abuse. At the July 10-11 meeting, the FDA will engage external thought leaders to discuss how to better “evaluate the impact of these products in the real world.” There is a link in the statement to an issues paper that outlines some of the existing regulatory and public health challenges they face.

Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction. Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge.

Sidney Wolfe, the founder of and senior advisor to Public Citizen’s Health Research Group supported the FDA request for Endo to remove Opana ER from the market. He also said the FDA had enough information before its approval in late 2011 to “reject the drug as possibly more dangerous than its older … version.” He was a member of the FDA’s Drug Safety and Risk Management Advisory Committee at the time, but for some reason, the approval decision was not presented to the Committee. Had the Committee advised rejecting the drug, and the FDA followed the Committee’s advice in 2011, the adverse effects leading the current request could have been avoided.

In addition to FDA’s serious mistake in approving the OPR version, Endo’s defiant response yesterday that they would not necessarily take this more dangerous form of the drug off the market is reckless. In proportion to how many people will use and, in many cases abuse the drug, causing deaths, hospitalizations and other preventable between yesterday’s FDA decision and the ultimate, but certain forced removal of the drug, Endo will be exposed to many product liability lawsuits from those damaged or their surviving families.

Endo suffered some significant financial withdrawal symptoms after the FDA request. The company’s shares were down more than 12% afterwards, according to Fortune. A financial analyst for RBS Capital Markets referred to Opana ER as a “declining asset” with sales expected to fall to $97 million in 2019 from an estimated $134 million in 2017. But Endo seems to have counted the potential future cost if it challenged the FDA recommendation and fought to keep Opana ER on the market. On July 6, 2017, Endo International announced it would voluntarily withdraw Opana ER from the market.

Ed Silverman reported for STAT News that Endo executives “blinked” by saying they were reconsidering their initial statement that they would review the FDA request and evaluate “the full range of potential options.” Silverman noted Opana ER hadn’t been a huge seller for Endo. And it seems the FDA request would impact sales even further. It only generated around $159 million in revenue in 2016. Through the first quarter of 2017, sales were $35.7 million, down from almost $44.7 million in the first quarter of 2016. Given the adverse impact on public health, and the potential for future product liability lawsuits, Endo did the right thing in deciding to go “cold turkey” with Opana.

07/14/17

Myth of Newton’s Clockwork Universe

photo from Wikipedia: “The Clockwork Universe” by Tim Wetherell

In his book The Blind Watchmaker, Richard Dawkins turned the watchmaker analogy, used by William Paley to argue for the existence of God, on its head. Paley said if we were to find a watch in a field, even if we didn’t know how it came into existence, the “intricacy of design” in the watch would force us to conclude that it had a maker. Since the natural world shows even more evidence of design than a watch, its existence implies an even greater intelligent Designer or God. However, Dawkins asserted that we now know that natural selection, “the blind, unconscious, automatic process … is the explanation for the existence and apparently purposeful form of all life.” Since it has no mind, vision or foresight, “If it can be said to play the role of the watchmaker in nature, it is the blind watchmaker.”

Dawkins placed his finger on the necessary assumption in Paley’s argument: there must be a cause for the observed order in nature. Deny this, as Norman Geisler pointed out in the Baker Encyclopedia of Christian Apologetics, and the teleological argument failed, “for the alleged design (if uncaused) would be merely gratuitous.” Despite his affirmation of natural selection and rejection of a causal agent for the evidence of design in nature, Dawkins still recognized the persuasiveness of an argument from design.

Natural selection is the blind watchmaker, blind because it does not see ahead, does not plan consequences, has no purpose in view. Yet the living results of natural selection overwhelmingly impress us with the appearance of design as if by a master watchmaker, impress us with the illusion of design and planning.

Rather like the ball in a tennis match, the notion of a clockwork universe has been batted back-and-forth to both support and undermine the belief in a Creator and/or Sustainer of the universe. Outside of Christian apologetics circles, where Paley’s watchmaker is a favored form of the teleological argument for the existence of God, the clockwork universe analogy is used to deny the belief in a sustaining Creator God. It has even been woven into a myth referred to by Edward (Ted) Davis as the “Newtonian Worldview.” Examples of this Newtonian myth of a clockwork universe are plentiful.

In an article celebrating the 150-year anniversary of Darwin’s theory of evolution, Johnjoe MaFaddon said while Darwin had destroyed the strongest evidence for the existence of a deity, “Two centuries earlier, Newton had banished God from the clockwork heavens.” In his essay on the myth of Newton’s mechanistic cosmology for Galileo Goes to Jail, Davis quoted from Sylvan Schweber’s 1989 essay, “John Herschel and Charles Darwin.” “The metaphor of the mechanical clock in Newton’s construction of the heavens and its legacy illustrate the power of metaphors in the development of scientific thought.” In an earlier essay, Davis quoted the following from the fourth edition of Thomas Greer’s A Brief History of the Western World:

With Aristotle’s laws of motion overthrown, no role remained for a Prime mover, or for Moving Spirits. The hand of God, which once kept the heavenly bodies in their orbits, had been replaced by universal gravitation. Miracles had no place in a system whose workings were automatic and unvarying. Governed by precise mathematical and mechanical laws, Newton’s universe seemed capable of running itself.

But as Stephen Snobelen pointed out in “The Myth of the Clockwork Universe,” the metaphor of a mechanistic, clockwork universe originated with medieval monks. “The myth of Newton’s clockwork universe is one of the most persistent and pervasive myths in the history of science.”  The idea of a “world machine” can be found in the astronomical works of Robert Grosseteste (1175-1253), Johannes de Sacrobosco (1230), and Nicolas of Cusa (1401-64). Copernicus used it in his seminal work, On the Revolutions of Heavenly Spheres. But it was Nicole Oresema (1325-82) who compared the idea of a world machine to the clockwork universe.

In these early theological contexts, the clockwork analogy has two essential features: God as creator of the clockwork and God as sustainer of the clockwork. Thus it differs from eighteenth- century, nonprovidentialist deism that is committed only to the first element.

Both Davis and Snobelen convincingly demonstrated how Newton himself did not hold to what has been portrayed as a mechanistic, Newtonian worldview. The early advocates of the clockwork universe were “pious, believing Christians;” and if Newton had used the clockwork metaphor, he would have likely used it like the “Christian natural philosophers who went before him.” Snobelen said not a single unambiguous example of Newton referring to the universe as a clockwork system has been identified. Davis noted where Newton’s belief and understanding of God’s dominion “shaped the metaphysical perspective in which he placed his science.”

Deistic, “nonprovidentialist” thinkers like Gottfried Leibniz and Rene Descartes refused to allow God to exercise dominion over creation. According to Davis, Newton saw the Cartesian concept of matter as a path to atheism. Descartes believed matter and extension (space) were necessarily indistinguishable. He thought all motion took place in closed loops; all changes in motion were caused by direct contact, and not by forces acting at a distance (i.e., God’s sustained actions in nature). “Newton claimed that matter ‘does not exist necessarily, but by divine will.’” Snobelen quoted Leibniz, who like Dawkins, turned the clockwork analogy on its head to refute the sustaining acts of God:

Sir Isaac Newton, and his Followers, have also a very odd Opinion concerning the Work of God. According to their Doctrine, God Almighty wants to wind up his Watch from Time to Time: Otherwise it would cease to move. He had not, it seems, sufficient Foresight to make it a perpetual Motion. Nay, the Machine of God’s making, is so imperfect, according to these Gentlemen; that he is obliged to clean it now and then by an extraordinary Concourse, and even to mend it, as a Clockmaker mends his Work; Who must consequently be so much the more unskilful a Workman, as he is oftner obliged to mend his Work and to set it right.

Snobelen said Leibinz’z idea of a perpetual motion machine implied an idealized Platonic clock, which he contrasted with an unreliable clock that needed frequent rewinding, “the kind of clock that would have been familiar to the original readers of this debate.” Because of the reliability of modern timepieces, we miss the slur Leibniz made here in his use of the clockwork analogy. Before the introduction of the balance spring or pendulum in the late 1600s, watches were very unreliable—sometimes losing minutes or hours of time in a day. It was only after the invention of the balance spring that minute and second hands became standard issue with all watches. So God’s sustaining work in creation was like a clockmaker winding, cleaning and mending his clock.

Newton has been co-opted by some as a “proto-deist” or the person who set the stage for a new rationalism that “set the stage for Enlightenment philosophies to remove God” from the ordering of things. But Snobelen said no deist would accept biblical prophecy as a revelation from God that has been and will be fulfilled in history. But Newton did. Davis said if we ignored the vast theological gulf between Newton and the philosophers who reinterpreted his physics, “we encourage the very opinion the Enlightenment deists wanted us to share: that theology and modern science are fundamentally at odds.”

A biographer of Newton said few things would have angered him more than the belief that “the Principia contained the framework of a universe in which God was no longer vital, or even necessary.” Correspondence between Leibniz and a friend and disciple of Newton’s named Samuel Clarke, which occurred during the last year of Leibniz’a life (1715-1716), explicitly rejected his caricature of God having to wind up His watch from time to time:

The notion of the world being a great Machine, going on without the Interposition of God, as a Clock continues to go without the Assistance of a Clockmaker; in the Notion of Materialism and Fate, and tends (under pretence of making God a Supra-mundane Intelligence) to exclude Providence and God’s government in reality out of the world.

Nevertheless, modern biblical Christians cannot follow Newton into all his theological beliefs. He rejected the doctrine of the Trinity; Davis thought he was an Arian. He also rejected the doctrine of the immortal soul, a personal devil and literal demons. But confusingly, when concluding his above linked essay, Snobelen said:

A careful reading of Newton’s massive corpus, both published and unpublished, reveals that he was, without question, committed to biblical Christianity—even if not always orthodox—and understood his own work, particularly his physics, in providentialist terms, reflective of his theistic and prophetic understanding of the cosmos.

Newton’s anti-trinitarianism is not disputed, and that alone would have him seen as heretical by most of Christianity. So it is unclear why Snobelen would say Newton was “committed to biblical Christianity.” In another essay, he clearly said: “Isaac Newton was a heretic.” He observed that Newton never made a public declaration of his beliefs, knowing that if he did, he had a lot to lose. Newton was aware he had enemies who would pounce upon any revelation of “doctrinal waywardness” to discredit him; he realized how the charge of heresy could damage his reformation of natural philosophy. “Fear of this sort of public relations disaster must have been one of Newton’s greatest deterrents to open preaching.”

07/11/17

Blind Spots with Antipsychotics, Part 1

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Carrie Fisher was flying back to her home in Los Angeles on December 23, 2016 when she went into cardiac arrest. She was removed from the plane and later died in the hospital. Her daughter, Billie Lourd, said: ““She was loved by the world and she will be missed profoundly.” She was a well-known actress, writer and humorist. She wrote six books, some of which described her life, loves and adventures, which included drug addiction and bipolar disorder. A series of articles lamented that she was taken too soon, but there wasn’t anything said about a possible connection between her sudden cardiac death (SCD) and the medication she took for her bipolar disorder.

Fisher was a vocal mental health advocate and talked freely about her bipolar disorder and over the years. An article contained the following statements made by Fisher about her mental health and use of medication. In an interview with Diane Sawyer in December of 2000, she said: “I am mentally ill. I can say that. I am not ashamed of that. I survived that, I’m still surviving it, but bring it on. Better me than you.” At a February 2001 rally in Indianapolis for increased state funding for mental health and addiction treatment, she said: “Without medication I would not be able to function in this world. Medication has made me a good mother, a good friend, a good daughter.”

Writing for Mad in America, Corinna West raised the question of whether Fisher’s too soon passing was related to her use of psych meds. West referred to an article in the European Heart Journal by Honkola et al. that concluded: “The use of psychotropic drugs, especially combined use of antipsychotic and antidepressant drugs, is strongly associated with an increased risk of SCD at the time of an acute coronary event.” Variety reported Carrie Fisher was taking Prozac (an antidepressant), Abilify (an antipsychotic) and Lamictal (a mood stabilizer).

This study confirms that combining antidepressants and old school [first generation] antipsychotics causes an 18-fold increase in death during a cardiac event. Combining antidepressants with any antipsychotic causes an over 5-fold increase in relative risk of death during a cardiac incident.

To put this into some context, West noted: “Vioxx was pulled from the market for a 2-fold increase in relative risk factor of strokes and heart attacks.” It may have led to the death of 50,000 to 70,000 people while it was on the market. She then did some speculative calculations and suggested psych meds may contribute to 74,191 additional heart attacks annually and 33,386 deaths from SCD per year.

She also noted how people with serious mental illness have a 25-year lower life expectancy than others and a significantly greater risk of myocardial infarction. The NASMHPD “Morbidity and Mortality Report” said that it has been known for several years that people with serious mental illness die younger than the general population. “In fact, persons with serous mental illness (SMI) are now dying 25 years earlier than the general population.” The report also said people with SMI also suffer from a greater percentage of modifiable risk factors associated with cardiovascular disease, such as obesity, smoking, diabetes, hypertension and dyslipidema (high cholesterol). Corrine West noted the data from the “Morbidity and Mortality Report” showed that psychiatric drugs increased 4 of the top 5 normal risk factors for cardiac disease. Smoking was included as a risk factor because many individuals using psych meds find the nicotine helps relieve some of the numbness caused by the meds. See the following chart from the report.

There is increasing evidence of multiple adverse effects from the long-term use of antipsychotics in addition to the risk of SCD. Murray et al. concluded there was a lack of evidence for the long-term effectiveness of prophylactic (maintenance) antipsychotic use; and a growing concern with the cumulative effects of antipsychotics on physical health and brain structure. “There is enough evidence concerning the adverse effects of antipsychotics on physical health to compel psychiatrists to act.”

Murray et al. said long-tem maintenance treatment with antipsychotics was “based on hope rather than evidence.” They pointed to two serious methodological problems. First, studies claiming that antipsychotic maintenance treatment substantially reduced the risk of relapse were often limited to two years of follow-up. Second, the studies compared schizophrenic patients continuing on antipsychotics with those who stopped taking antipsychotics, not individuals who never used the drugs. So the withdrawal effect from antipsychotics in the discontinuation group influenced the higher relapse rates, making it a confounding variable to the supposed positive results with antipsychotic maintenance treatment.

The Murray et al. researchers did think there was no clear link between antipsychotic-associated changes in brain structure and cognitive decline or functional impairment. However, studies like that of Ho et al. suggested antipsychotics can “have a subtle but measurable influence on brain tissue loss over time.” Ho et al. said there was also a problem with dopamine receptor supersensitivity in some antipsychotic users. This supersensitivity could be a factor in the decreased efficacy of antipsychotics with continued prescription; and it may contribute to relapse when an individuals stops using antipsychotics. “There is an urgent need for neurochemical imaging studies addressing the question of dopamine supersensitivity in patients.”  In their conclusion, the researchers gave the following recommendations.

[The wise psychiatrist] will treat acute psychosis with the minimum necessary dose of antipsychotics, employing weight sparing antipsychotics wherever possible; dopamine partial agonists have this property and may also be less likely to induce dopamine supersensitivity. Following recovery, the psychiatrist should work with each patient to decrease the dose to the lowest level compatible with freedom from troublesome psychotic symptoms; in a minority of patients, this level will be zero.

You can read a summary review of the study by Justin Karter on Mad in America here.

Not all of the above-cited researchers agreed with the conclusions of each other. But collectively they pointed to evidence of a link between antipsychotics and adverse cardio vascular events, brain shrinkage, and dopamine supersensitivity.  Murray et al. also suggested that studies of long-tem antipsychotic maintenance treatment unfairly stacked their results in favor of antipsychotic maintenance by using patients who were withdrawn/discontinued from using antipsychotics as their control group. So when the recent press release from Columbia Medical Center regarding Goff et al. concluded the benefits of antipsychotics outweigh the risks was disconcerting and confusing at first. The Goff et al. abstract asserted: “Little evidence was found to support a negative long-term effect of initial or maintenance antipsychotic treatment on outcomes, compared with withholding treatment.”

The press release acknowledged the above concerns that antipsychotic medications have been said to have toxic effects and negatively impact long-term outcomes. However it went on to say that if this view was not justified by data, it had the potential to “mislead some patients (and their families) to refuse or discontinue antipsychotic treatment.” Therefore a team of researchers led by Jeffrey Lieberman, the Lawrence C. Kolb Professor and Chairman of Psychiatry at Columbia University College of Physicians and Surgeon, undertook “a comprehensive examination of clinical and basic research studies that examined the effects of antipsychotic drug treatment on the clinical outcomes of patients and changes in brain structure.” Lieberman was liberally quoted in the Columbia press release with regard to their findings supporting how the benefits of antipsychotics outweigh the risks. He said:

The evidence from randomized clinical trials and neuroimaging studies overwhelmingly suggests that the majority of patients with schizophrenia benefit from antipsychotic treatment, both in the initial presentation of the disease and for longer-term maintenance to prevent relapse. . . . Anyone who doubts this conclusion should talk with people whose symptoms have been relieved by treatment and literally given back their lives.

Lieberman went on to suggest that only a very small number of individuals recover from an initial psychotic episode without the use of antipsychotic maintenance treatment. “Consequentially, withholding treatment could be detrimental for most patients with schizophrenia.” He acknowledged where rodent studies suggested antipsychotics can sensitize dopamine receptors, but “there is no evidence that antipsychotic treatment increases the risk of relapse.” Further, although antipsychotic medications can increase the risk of metabolic syndrome, which is linked to heart disease, diabetes and stroke, their study did not include a risk benefit analysis of this concern.

Wait a minute. Why didn’t their study include a risk benefit analysis for metabolic syndrome? It seems to be one of the most reliably documented adverse effects, as noted above. Could it be that the intended message of the research—namely how strong evidence supports the benefits of antipsychotic medications—would not have been as clearly communicated if the risk benefit analysis concluded there was a substantial risk of metabolic syndrome? By the way, according to the Mayo Clinic,

Metabolic syndrome is a cluster of conditions — increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels — that occur together, increasing your risk of heart disease, stroke and diabetes. Having just one of these conditions doesn’t mean you have metabolic syndrome. However, any of these conditions increase your risk of serious disease. Having more than one of these might increase your risk even more. If you have metabolic syndrome or any of its components, aggressive lifestyle changes can delay or even prevent the development of serious health problems.

Dr. Lieberman has been a vocal advocate of modern psychiatry and equally critical of those who question many of its claims, as with those documented here. My previous encounters with his presentation of evidence and data, like his discussion of the conclusions of Goff et al. above, have led me to be skeptical of his conclusions without further investigation. I believe his fervent desire to defend modern psychiatry and current psychiatric methods has distorted how he interprets and presents conflicting evidence. He seems to have a blind spot when assessing and interpreting evidence counter to his position. The above question about the failure to include a risk benefit analysis of metabolic syndrome is one illustration of what I mean.

So what do others have to say with regard to the Goff et al. study? We’ll look at some of those critiques in part 2 of this article.

07/7/17

More Equal Therapies than Others, Part 2

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In his introduction to ”The Doctor’s Opinion” in the A.A. Big Book, Bill W. said A.A. favored initial hospitalization for the alcoholic who was “jittery or befogged.” It was imperative that the person’s brain was cleared so he then had a better chance “of understanding and accepting what we had to offer.” The reason to include Dr. Silkworth’s endorsement in Alcoholics Anonymous was to document a “medical estimate” of the A.A .12-Step plan of recovery.  “Convincing testimony must surely come from medical men who have had experience with the sufferings of our members and have witnessed our return to health.” But that was almost eighty years ago; and there have been some radical changes in the receptiveness of 12-Step recovery.

In modern addiction treatment there are a growing number of voices saying A.A.’s 12-Step approach should either be taken out of the treatment game or sidelined as a “recovery support service” (RSS) instead of being an integral part of the addiction treatment process. However, it would restrict or bench a valuable asset to addiction recovery. The rationales given for this generally follows two lines of argument.

One way is to portray A.A. and other 12-Step groups as religious or cultish in nature. This distortion stems from the secularization of American culture since the late 1930s when A.A. began, as well the failure to make a distinction between spiritual and religious consistent with 12-Step philosophy. See “Spiritual not Religious Experience” for a discussion of this distinction and a response to the accusation that the spiritual nature of A.A. disqualifies it from being used within addiction treatment. The second route is to suggest the 12-Step approach does not fit with the modern medical model of addiction treatment.

In the first ten years of A.A.’s existence the fellowship became convinced that organizationally it had to permanently remain nonprofessional. This was eventually formalized in Tradition Eight. Concurrent with that realization, was the origin of what would be called the Minnesota Model of addiction treatment. The Hazelden Foundation (now the Hazelden Betty Ford Foundation) blended professional and trained nonprofessional staff within a treatment approach based on the 12-Step philosophy of A.A. Throughout the 1950s, Hazelden honed it treatment model on three working principles.

First, alcoholism was seen as a primary condition and not just a symptom of an underlying disorder. Second, alcoholism was a disease and should be treated as such. The American Medical Association (AMA) officially identified alcoholism as a disease in 1956. Third, following the A.A. idea of the alcoholic suffering physically, mentally and spiritually, alcoholism was said to be a multiphasic illness. “Therefore treatment for alcoholism will be more effective when it takes all three aspects into account.” Abstinence was an integral goal of treatment.

These principles set the stage for a model that expanded greatly during the 1960s—one that has been emulated worldwide and has merged the talents of people in many disciplines: addiction counselors, physicians, psychologists, social workers, clergy, and other therapists. These people found themselves working on teams, often for the first time. And what united them was the notion of treating the whole person—body, mind and spirit.

Cracks began to appear in the dominance of the Minnesota Model of addiction treatment even as its hegemony grew in the 1960s. Methadone maintenance as a treatment for heroin addiction arose in the early 1960s. In the 1980s, the biological model of psychiatry began its ascendency and in 1991 the AMA took the further step of endorsing a dual classification of alcoholism as both a psychiatric and a medical disease. In 1992 SMART Recovery began. “SMART Recovery is based on scientific knowledge, and is intended to evolve as scientific knowledge evolve.” In 1994 Moderation Management became a self-help group for individuals who wanted to moderate, not abstain from alcohol.

Addiction professionals developed diverse alternatives to addiction treatment centered on 12-step philosophy. Stanton Peele developed Life Process Program as an alternative to 12-Step treatment, which he now offers as an online program. Marc Lewis wrote The Biology of Desire, refuting the medical view of addiction as a brain disease. He conceived it as an extreme form of learning.

Lance Dodes wrote The Sober Truth, purportedly debunking the bad science behind 12-Step programs and the Rehab industry. It claimed to be an expose of Alcoholics Anonymous, Twelve Step programs and the rehab industry—how “a failed addiction-treatment model” came to dominate America.

David Sinclair developed the Sinclair Method, which conceived of alcoholism as a learned behavior, one that can be removed by the behavior modification principle of extinction. “The solution discovered by Sinclair effectively means you have to drink yourself sober!” And there are others. But the medical model, although it has been modified, remains supreme in addiction treatment.

In the 1990s, a movement began in medicine to develop evidence-based practices (EBP). A widely accepted definition of EBP by Dr. David Sackett is that EBP is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”  When applied to addiction treatment, the principle is generally referred to as evidence-based treatment (EBT). The National Institute on Drug Abuse (NIDA) simply referred to EBTs as treatment approaches “that have an evidence base supporting their use.” The website GoodTherapy.org elaborated, saying that EBT was “treatment that is backed by scientific evidence.” This referred to extensive research, which has been documented and demonstrated to be effective on a particular treatment.

Consistent with this understanding, NIDA listed a manualized Twelve Step based treatment model called Twelve Step Facilitation (TSF) as an evidence-based behavioral therapy. TSF actively seeks to engage substance abusers in becoming involved in 12-Step groups, “thereby promoting abstinence.” However, a writer and researcher for Handshake Media, Laurel Sindewald, concluded in her article, “AA Is not Evidence-Based Treatment,” that NIDA wrongly listed TSF as evidence-based.

In Part 1 of this article, “More Equal Therapies than Others,” is a description of TSF and a discussion of how Sindewald’s critique wrongly and inconsistently grouped A.A. and other 12-Step groups with treatment approaches like the Minnesota Model and TSF that use 12-Step philosophy. Her provocative title is the result of mistakenly grouping A.A. and treatment approaches based on 12-Step philosophy together; and then illegitimately transferring her critique of these 12-step treatment approaches to A.A. A.A. sees itself as a fellowship and not a treatment. Here we will briefly look at how Sindewald’s narrowing of the NIDA sense of “evidence-based treatment” allowed her to conclude TSF was not evidence-based.

As was described in Part 1, Sindewald gave a biased description of 12-Step philosophy, stating it viewed addiction as merely “a spiritual disease born of defects of character.” Twelve Step groups supposedly said they were the only cure, “involving faith in a higher power, prayer, confession, and admission of powerlessness.” Contrasted with the NIDA definition of addiction as a disease of the brain, she asked how TSF as a professional medical treatment could be based on an understanding of addiction as a spiritual disease. Note the rhetorical sleight-of-hand in how she conveniently left out the A.A. and 12-Step understanding of addiction as a physical, mental and spiritual illness/disease.

Another place Sindewald used the same tactic was where she defined evidence-based. “In this article, I define ‘evidence-based’ to mean any treatment supported by numerous scientific experiments with rigorous methods that include control groups, randomization of patients to treatments, and bias-free samples. Note how her sense of “evidence-based” is more restrictive than NIDA, GoodTherapy.org and even Sackett’s widely acknowledged sense of evidence-based practice for medicine.  Her criteria seem to be even more restrictive than the American Psychological Association’s criteria for well-established “empirically validated treatment” in the “APA Task Force on Promotion and Dissemination of Psychological Procedures” Refer to Table 1 for the criteria.

Gianluca Castelnuovo wrote an article for Frontiers in Psychology on “Empirically Supported Treatments in Psychotherapy.” Consistent with the broader NIDA sense of evidence-based, he said the term evidence does not have one single definition. “evidence-based practice (EBP) includes many forms of evidence other than data from RTCs [randomized control trials].” There are two contradictory visions of what causes change in psychotherapy. One approach emphasizes the primacy of therapist and technique. The second vision focuses of the patient-therapist relationship and what the client brings to the therapeutic relationship.

The first vision sees the specific methods used by the psychotherapist as accounting for, by far, most of the changes in therapy. “Other factors (e.g., therapist relational qualities, patient–therapist relationship) are secondary, at best. This viewpoint is seen most notably in what have been termed the EST and EBP movements.” This approach conducts tightly controlled outcome studies, where specific treatments are pitted against one another or a control group and applied to specific disorders, usually as defined in the DSM. This describes the Project MATCH study, for which TSF was developed. This first sense proceeds from a medical model of “diagnosis plus prescriptive treatment equals symptom amelioration.”

The second view of psychotherapeutic change attributes most positive therapeutic outcomes to client factors (40%) and the therapeutic relationship between client and therapist (30%). The technique used and the skill of the therapist accounts for the remaining 30% of positive therapeutic outcomes. This so-called “common factors approach” then discourages attempts to pit one therapy against another or against a placebo group of no treatment (clients placed on a waiting list) as ultimately doomed to failure, since all therapies have the same potential for positive outcomes (the dodo bird effect).

When discussing the significance of common factors in “The Legacy of Saul Rosenzweig: The Profundity of the Dodo Bird,” Barry Duncan noted how experienced therapists know psychotherapy requires the unique tailoring of a therapeutic approach to a particular client and circumstance. And if a therapist attempts to do therapy by the book, it often doesn’t go very well. There are limitations to manualized therapies, even TSF.

The structure minimizes the factors brought to therapy by the client. It restricts or eliminates the therapeutic relationship between client and therapist. And it emphasizes the factors (therapist and technique), which typically have the least positive outcome effects. If you want to determine whether a therapeutic approach is “evidence-based” or “more equal” than other therapies when treating a designated DSM disorder, you will likely use a structured, manual-based treatment.

For more information of the therapeutic power of common factors and the dodo bird effect, see the above-linked article by Barry Duncan. Also read the Wampold et al. article, “A Meta-analysis of Outcome Studies Comparing Bona Fide Psychotherapies: Empirically, ‘All Must Have Prizes’”; or “The Dodo Bird Effect” and “Another Brick in the Wall” on this website. If you are interested in exploring “the science behind 12 Step recovery,” try If You Work It, It Works! by Joseph Nowinski.

07/4/17

Balancing Act with Human Origins

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A recent Gallup poll found the percentage of U.S. adults who believe God created humans in their present form within the last 10,000 years, what Gallup called the strict creationist view, has reached a new low. They are now tied with those who believe God guided humans development over millions of years at 38%. “This is the first time since 1982 — when Gallup began asking this question using this wording — that belief in God’s direct creation of man has not been the outright most-common response.” The “secular” view—that humans evolved from lower life forms without any divine intervention—has doubled since 1982, from 9% to 19%.

Reflecting on the Gallup poll results, Deborah Haarsma said that while polls are not infallible, BioLogos was encouraged to see these trends took place during the years in which BioLogos has been at work. “Anecdotally, we are seeing more openness to discussing the scientific evidence for human origins in the context of biblical faith . . . While loud voices continue to push extreme positions on origins, either anti-science or anti-God, this study shows that many everyday Americans are open to a conversation that brings science and God together.” These results are illustrated in the following graph found in the Gallup poll, which was conducted at the beginning of May in 2017. The results suggested to her that those who changed their views from a strict creationist position adopted the “God guided” position on evolution.

Gallup concluded that higher education levels effected creation/evolution belief in a strict (young earth) creationist position. Among those with postgraduate education, 21% said they believed in a strict creationist view versus 48% among individuals with no more than a high school education. “Agreement with evolution without God’s involvement is 31% among postgrads versus 12% among Americans with a high school education or less.” See the Gallup poll link for a table containing these results.

Nevertheless, among individuals with a college degree or above, more believed God had a role in evolution than who said evolution occurred without God. Haarsma pointed out that sociologist Jonathan Hill concluded from his research (the National Study of Religion & Human Origins, NSRHO) that education level was not the primary influence on views of human origins. Rather than education, differences in positions on human origins are better attributed to the religious beliefs of groups the individual belongs to.

When we track the beliefs of close friends and family, creationists are substantially more likely to belong to networks who agree with them about human origins. They are also more likely to expect increased disagreements with family and friends if they were to change their beliefs. Likewise, creationists are more likely to belong to congregations who have settled positions that reject human evolution and to perceive disagreements with religious leaders and other congregants if they were to change their beliefs. Moreover, creationists are more likely to spend their schooling in science classrooms that did not endorse evolution. Even if this is restricted to public high schools and universities, their science classroom experience is different from others. Put simply, creationists are embedded in networks and institutions that are more effective than the other groups in reinforcing the content and importance of their beliefs.

The bottom line for the Gallup poll was that most Americans believe God had a role in creating human beings. “But fewer Americans today hold strict creationist views of the origins of humans than at any point in Gallup’s trend on the question, and it is no longer the single most popular of the three explanations.” However, strict (young earth) creationism is still tied for the leading view at 38% of the population.

But Jonathan Hill found when you tease out individual beliefs for strict creationists, only 8% affirm all six beliefs, namely: (a) humans did not evolve from other species, (b) that God was involved in the creation of humans, (c) that God created directly and miraculously, (d) that Adam and Eve were historical figures, (e) that the days of creation were literal twenty-four hour days, and (f) that humans came into existence within the last 10,000 years.

Additionally, when deconstructing respondents who hold to a theistic evolution perspective in the Gallup poll (38% said humans developed over millions of years with God guiding the process), Hill found that only 16% of respondents (a) believed in human evolution and (b) God or an intelligent force were somehow involved. Only half of this group was very or absolutely confident of both of these beliefs. When applying a stricter definition to this group, only 5% of the population (a) believed God was involved in human evolution, (b) the days of creation were not literal, and (c) humans emerged more than 10,000 years ago. Requiring certainty dropped the percentage to 2%. “It is clear that the theistic evolution position does not come with a high degree of confidence for much of the population.”

When asking how social factors influence beliefs in young earth or evolutionary creation beliefs, certain factors become important in predicting firm, certain belief. The factors having the largest influence on predicting who is a certain (young earth) creationist included: (a) belonging to an evangelical denomination, (b) reporting faith is important in day-to-day life, (c) frequent prayer, (d) believing the Bible is literal (with no symbolism) or the inspired Word of God (symbolism but no errors), (e) family members with the same belief about origins, (f) friends have the same beliefs about origins, (g) changing beliefs would cause disagreement with other congregants and religious leaders, (h) their congregation has a settled position that rejects evolution.

Important factors predicting confident, certain evolutionary creation beliefs included: (a) belonging to a mainline (versus an evangelical) Protestant church, (b) being Catholic versus evangelical Protestant), and (c) not believing the Bible is the literal or inspired Word of God without errors.

Hill concluded that the social context of these beliefs is just as important as individual factors such as religious identity, practice and belief. “Social networks of family and friends, congregations, and schools all play a role.” Most important for strict creationists is the combination of certain religious beliefs, particularly beliefs about the Bible, and social contexts such as those related to a religious congregation. For individuals who believe human evolution is compatible with orthodox Christian faith, persuasion has to move beyond a purely intellectual level. Ideas consistent with evolutionary creation are only persuasive “when individuals are in a social position that allows them to seriously consider what is before them.”

There has been a tendency in evangelical Christian circles to see only two views with regards to human origins—creation or evolution. Data from the latest Gallup poll and the earlier NSRHO survey by Jonathan Hill suggests this rigid, and false dichotomy of views is changing. Consistent with these views on origins has been a parallel conflict thesis between science and religion, which also seems to be weakening.

In another article on a Pew study into religion and science, Hill pointed out the difficulty of holding onto a belief in the ultimate compatibility between science and faith, when you are not exactly sure how that compatibility should be realized. For now, it’s like balancing on a tightrope. But the decline in evangelicals who see an inherent conflict between their faith and science is an encouraging trend. But there is still a ways to go. See the NSRHO or “Did God Make You?” for more information and discussion on this topic. Also see the links for “Genesis & Creation” and “Religion & Science” on this website.