Tag Archives: Counseling Issues

07/11/14

Restoring the Ancient Ministerial Work

BaxterJ. I. Packer called Richard Baxter the most outstanding pastor, evangelist and writer that Puritanism produced. He was the vicar of the church in Kidderminster from 1647 to 1661. When he arrived in Kidderminster, Baxter said the towns people were “an ignorant, rude and reveling people.” Yet in 1743, when George Whitfield visited Kidderminster over eighty years later, he said to a friend: “I was greatly refreshed to find what a sweet savour of good Mr. Baxter’s doctrine, works and discipline remained to this day.”

According to Baxter, pastoral ministry should be a combination of public preaching and private conference (counseling). He thought the two activities complemented each other. First, members of the congregation would better understand the sermons. Second, getting to know your people would help the pastor know what he should preach on.

Baxter saw personal catechizing and instruction of every willing person within the congregation as the duty of the pastor. He said: “It is but the more diligent and effectual management of the ministerial work. It is not a new invention, but simply the restoration of the ancient ministerial work.” He suggested that a pastor should set aside two days out of six for the personal instruction of individuals within his parish. If the pastoral work grew to the point that he could not keep up with the need, then another minister should be hired.

He hoped that no one would be silly enough to say that individual conferences weren’t preaching. “What? Do the number we speak to make it preaching? Or doth interlocution [dialogue] make it none? Surely a man may as truly preach to one, as to a thousand.” If you examined the New Testament, “you will find that most of the preaching [there] was by conference.”

Anticipating the objections to his advocacy of private conferences, Baxter commented how some ministers may point to their labors in the public teaching. Why then should they obligated to teach congregants individually besides this? Baxter’s answer went to the heart of the matter. Some who come for private meetings would be “grossly ignorant” in matters of their faith. Yet in one hour of private, instruction, “they seem to understand more, and better entertain it than they did in all their lives before.”

Among the seventeen benefits of private conference, Baxter said:

  • It would help to convert individuals.
  • It would promote the orderly building up of those who are converted and help establish them in the faith.
  • It will make the public preaching better understood and regarded.
  • By it you will become familiar with your people and possibly win their hearts.
  • In becoming better acquainted with each person’s spiritual state, you can better know how to watch over him or her.
  • It will help with the better ordering of families.

In a previous post on preaching and counseling, “Preaching and Counseling Are Complementary” I referred to Carl Truemen’s article for Reformation 21, “Why is So Much Preaching So Poor?” Perhaps the answer to Trueman’s question should be that modern preaching is so poor because modern pastors have largely lost the connection with their church members that Richard Baxter had because of his private conferences.

Also read, “Preaching and Counseling Are Complementary.”

07/9/14

Preaching and Counseling Are Complementary

John Wesley

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Carl Trueman wrote a helpful article for Reformation 21 that discussed why much of modern Protestant preaching was so poor. But in his third point, he said something that I found troubling since I am a counselor by profession and calling. Dr. Trueman said in our culture, there was a “relativizing of the preached word and the growth of emphasis on one-to-one counseling.” He quickly acknowledged the usefulness of one-to-one counseling. But then commented how he thought most of the problems people experienced could be adequately dealt with from the pulpit.

What Dr. Trueman said next seems to be why he sees counseling and preaching at odds with one another in our culture. The world tells us we are unique, with unique problems. “Talk of our uniqueness is greatly exaggerated. We need to create a church culture where uniqueness is relativized and where people come to church expecting that the preached word will meet their particular problem.” True, but oftentimes this may not be enough.

In The Reformed Pastor, Richard Baxter noted how he met with people who had sat under his preaching for eight or ten years and yet did not know whether Christ was God or man. Even when an individual knew the gospel, they often had an ungrounded trust in Christ. They hoped He would pardon, justify and save them; but the world had their hearts.

Dr. Trueman is correct. There is individualism and self-centeredness in American culture and in counseling. In Psychology as Religion: The Cult of Self-Worship, Paul Vitz called it selfism. He described Americans as having a Burger King mentality: Have it your way!

Counseling that panders to selfism is theologically wrong and spiritually damaging. Preaching that panders to selfism is also theologically wrong and spiritually damaging. But counseling and preaching can and should be co-laborers in the ministry of the gospel. They don’t have to be opposed to one another. Again, Richard Baxter spoke to this concern.

Baxter said preaching the gospel publicly is the preferred means, because we can speak to many people at once. “But it is usually far more effectual to preach it privately to a particular sinner.” Public sermons are long and can over-run a person’s understanding and memory. People may become confused and therefore are not able to follow the preacher. So then they do not understand what was said, regardless of how effectual the preaching was to others.

“But in private we can take our work gradatim, [step by step] and take our hearers along with us.” By the questions we ask and their answers, we can see how far they understand us. Publicly, we lose their attention through the length of what is said and the lack of an opportunity to respond to what was said. Privately, we can easily cause them to pay attention. And we can more effectively engage them and answer their questions. Baxter urged that his fellow ministers would see preaching and personal instruction (counseling) as complementary:

I conclude, therefore, that public preaching will not be sufficient: for though it may be an effectual means to convert many, yet not so many, as experience, and God’s appointment of further means, may assure us. Long may you study and preach to little purpose if you neglect this duty.

Counseling that is biblically-based complements preaching. In the Introduction to Competent to Counsel, Jay Adams said: “It is amazing to discover how much the Bible has to say about counseling, and how fresh the biblical approach is.”

Also read, Restoring the Ancient Ministerial Work.

07/2/14

Thor’s Psychiatric Hammer: Antidepressants

60 Minutes broadcast a segment on treating depression in February of 2012 that is still causing ripples of controversy. Two of the individuals interviewed, Irving Kirsch, a Harvard psychologist and Walter Brown, a psychiatrist with Brown University, challenged the two accepted pillars of current depression treatment. Kirsch said: “The difference between the effect of a placebo and the effect of an antidepressant is minimal for most people.” According to Brown, “The causes of depression remain a mystery.”

The chemical imbalance theory, which has guided the pharmaceutical industry in developing new drugs since the 1960s, is “probably incorrect.” Brown added that the experts in the field, the academic people who do research on drugs, now believe that the chemical imbalance theory is “a gross oversimplification.” If the neurotransmitters serotonin, norepinephrine, dopamine have anything to do with depression, “it’s of a minor role and probably sets the stage for depression. But they’re not the cause of depression. I think we know that now.”

Yet the chemical imbalance theory is still widely taught in medical schools. Many psychiatrists and mental health professionals still believe it. “The problem in psychiatry is that we don’t have a lot of tools. And if the only tool you have is a hammer, you treat everything as if it is a nail.”

Irving Kirsh has been doing research into the placebo effect for over 35 years. His original research intent with antidepressants was to evaluate the size of the placebo effect with antidepressants. He was a believer in the efficacy of antidepressants and he used to refer people to get antidepressant prescriptions. “I didn’t change the focus of my work onto looking at the drug effect until I saw the data from our first analysis.”

In a 1998 study, Kirsch found that 75% of the response to antidepressants was duplicated by placebo. He did a follow up study in 2002, where he analyzed the data submitted to the FDA for the six most widely prescribed antidepressants approved between 1989 and 1999: Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Effexor (venlafaxine), Serzone (nefazodone), and Celexa (citalopram).  He found a small but significant difference between the antidepressant drugs and inert placebo. “If the drug effect is as small as it appears … then there may be little justification for the clinical use of these medications.”

Leslie Stahl challenged Kirsch, saying that people are getting better by taking antidepressants. He agreed. “People get better when they take the drug. But it’s not the chemical ingredients of the drug that are making them better. It’s largely the placebo effect. . . . The only place where you get a clinically meaningful difference [with an antidepressant] is at these very extreme levels of depression.” The placebo effect is stronger with mild depression.

Both Kirsch and Stahl cautioned that antidepressants should not be stopped cold turkey. Leslie Stahl said that individuals who take antidepressants, and feel better as a result, will likely continue to take them. But she worried about the side effects. For some people there are serious side effects. “And if a sugar pill is just as good, how can we keep prescribing these pills?”

For more information on antidepressants, see: “Antidepressant Withdrawal or Discontinuation Syndrome?” and “Antidepressants: Their Ineffectiveness and Risks” under the Resources: Counseling Issues menu.

06/25/14

Let the Marriage Bed Be Undefiled

One woman told me that she didn’t think she could even tell her closest female friend some of the things her husband had forced her to do sexually. Another woman spent about two months in counseling accompanied by her best friend before she trusted enough to meet with me alone. A woman went with a friend of hers to a conference on abuse to be supportive of the friend. She left the conference with an awareness of how her husband had sinned against her sexually. All three of these marriages were between professing Christians. All three husbands used pornography at some point in their lives.

I first heard about When Your Husband is Addicted to Pornography by Vickie Tiede from a pastor as we talked about individuals and couples who struggle with porn addiction. Then someone I was counseling said reading it had really helped her. Then I heard that Harvest USA endorsed it, and finally read it. I was using another Harvest recommendation, Closing the Window by Tim Chester, when counseling men with sexual addiction problems. Now When Your Husband is Addicted to Pornography and Closing the Window are my one-two punch in reading assignments when I counsel couples struggling with porn addiction.

From the very beginning, Tiede reaches out to minister to women hurting because of their husband’s pornography addiction. “If you are reading this introduction, it’s most likely because God had unveiled your husband’s secret addiction to lust, masturbation, and pornography. Perhaps I am the first to say this to you: I’m so sorry.” Her gentle, personal tone is evident even in the midst of honestly telling it like it is. She frequently shares from her own experience and those of other women to illustrate her various topics.

As she said in a YouTube video (available on her website, vickitiede.com): “I wrote this book because it’s my story.” Her first husband was addicted to pornography. She clearly tells her readers that the book is not a handbook to fix their husband. “It is for and about you, not your husband.”

The chapters of her book are structured as six “weeks” of themes, with five “days” of reading and contemplation around each theme: hope, surrender, trust, identity, brokenness, and forgiveness. The discussion themes are carefully grounded in Scripture. Vickie’s discussion of forgiveness is one of the best-reasoned and balanced ones I’ve ever read.

Discussion, testimony, bible study and assignments that apply to the material are throughout the book. She also lists several helpful resources, including internet filters, support groups and workshops, Christian ministry websites and professional counseling resources. As Vickie suggests, keep this resource handy to give out when there is an unexpected conversation with a neighbor or friend (or someone you counsel) whose husband struggles with porn addiction.

There is no biblical justification for using pornography. And whether a husband uses porn to feed his own lust or spice up his marital sex life, he abuses his wife and defiles his marriage. Let marriage be honored by all, and let the marriage bed be undefiled, for God will judge the sexually immoral (Hebrews 13:4). Unfortunately, there is a crucial need for Vickie Tiede’s book. Fortunately she had the courage to write it.

06/20/14

Groanings Too Deep for Words

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My personal spiritual journey includes experiences of God talking to me; words of knowledge or discernment; praying in tongues and prophetic utterance. But I do not see myself as a charismatic or Pentecostal Christian. Nor do I think these experiences are more profound than insight gained from reading and studying the Bible. Well, maybe the time God talked to me should be reserved as a more profound experience; especially since it didn’t occur as a result of ingesting psychedelic drugs.

Recently I discovered an online dialogue about these experiences stemming from T. M. Luhrmann’s book, When God Talks Back. I think she has given us some great insight into the psychic mechanisms by which we encounter God. Here is my attempt to add two cents worth to that discussion: We need to recognize a distinction between discursive and non-discursive thought.

In her classic work Philosophy in a New Key, Susan Langer said that all language has a form that requires us to string out our ideas as if we were hanging them on a clothesline; even though these ideas may actually nest one within the other like layered clothing on a cold, windy day. This property of verbal symbolism is called discursiveness. And only when our thoughts are arranged discursively can they be spoken. “Any idea which does not lend itself to this ‘projection’ is ineffable, incommunicable by means of words.” Langer added that this was why the laws of reasoning are sometimes known as the “laws of discursive thought.”

Non-discursive expressions of our inner mental life are not linguistically structured. They exist in an incommunicable, largely unconscious mental state of emotions, feelings and desires. Some expressions of this inner mental life are seen in tears, laughter, or profanity. Langer said this leads to two basic assumptions: 1) that language is the only means of articulating thought, and 2) everything that is not speakable thought is feeling.

Langer then said that human thought is like a tiny, grammar-bound island in the midst of a sea of feeling. This island has a periphery of “mud”—a mixture of factual and hypothetical concepts broken down by the emotional tides into a “material” mode: a mixture of meaning and nonsense. Most of us live our lives on this mud flat. In artistic moods we will take to the deep, “where we flounder about with symptomatic cries that sound like propositions about life and death, good and evil, substance, beauty and other non-existent topics.” I’d substitute the word “immaterial” for Langer’s term “non-existent.” She then said:

So long as we regard only scientific and “material” (semi-scientific) thought as true cognitions of the world, this peculiar picture of mental life must stand. And if we admit only discursive symbolism as a bearer of ideas, “thought” in this restricted sense must be regarded as our only intellectual activity. It begins and ends with language; without the elements, at least, of scientific grammar, conception must be impossible.

Building on this discussion, I’d agree with Langer that conscious thought, which we use to structure the world around us, is essentially discursive. Our unconscious thought life of feelings, emotions and desires is then mostly non-discursive and largely not available to us, unless it somehow manages to press its way through to the conscious, discursive world.

A biblical expression of this distinction is found in Romans 8:26: “Likewise the Spirit helps us in our weakness. For we do not know what to pray for as we ought, but the Spirit himself intercedes for us with groanings too deep for words.”

There is a human tendency to give greater significance to discursive impressions that appear suddenly, fully formed out of our unconscious thought life. I think this is true religiously as well as psychologically. Oftentimes these insights appear while the person is concentrating on something entirely different; and also when they are dreaming.

Charismatic and Pentecostal Christians see discernment, prophetic utterance and speaking in tongues as miraculous manifestations of God’s presence. But they could simply be unexpected encounters with God that take place as they go swimming in the sea of their immaterial, unconscious thought life.

Psychological theorists such as Sigmund Freud and Carl Jung similarly place a high value on the content of dreams as manifestations of the unconscious thought life of the individual. But they are no more significant that the material gathered by the practice of discursive “talk therapy.”

06/18/14

Sometimes I Hate Marital Counseling

There are times when I really hate doing marital counseling. Sometimes it feels like I am watching a gun fight. Other times I feel like a dentist, trying to pull impacted wisdom teeth. Then there is the couple that waits until their marriage is on life support before seeking help.

A female friend once told me about a twenty-something niece of hers who was undecided about accepting her boyfriend’s marriage proposal. They were both Christians. They loved each other and the woman did want to marry him, but she was afraid. She was afraid their marriage would turn out like her parents.

Every Sunday her family would go to church together. When they returned home, her parents resumed living separate lives under the same roof. Whatever were the problems in the relationship, her parents had long ago stopped trying to resolve them, stopped trying to nourish and cherish each other.

Too few Christian couples in trouble seek to become an Ephesians five example of Christ and the church.  Once a woman asked me,“ What does that look like?” I told her to study what Paul said in Ephesians four and the first part of chapter five about how Christians are to live as one body. An Ephesians five marriage looks like a husband and wife trying to jointly “walk in a manner worthy of the calling to which you have been called.” (Eph 4:1) Often when counseling Christian couples I see exactly the opposite of this.

For several years now I’ve used Leslie Vernick’s The Emotionally Destructive Relationship when working with couples in crisis. She has a copy of the “Emotionally Destructive Relationship Test” from the book available on her website that I’ve found very helpful. This test is designed to look at multiple relationships—marriages, parent-child, siblings, friends.

She has also written The Emotionally Destructive Marriage, specifically for wives in controlling, destructive, abusive marriages. As she said in her Introduction, there are many good books about how to be godly wife or how to build a successful and happy marriage. “There aren’t many books written on how to wisely deal with a destructive and abusive marriage.” In my opinion, this is the best.

There is an Emotionally Destructive Marriage Test to help the reader evaluate whether or not she is in an emotionally destructive marriage. She helps wives see their marriage clearly. She challenges them to accept that change begins with them. Building four CORE strengths is the heart of that change, “with God at the center and with his help.” Another helpful assessment tool is “Sixteen Traits of a Healthy Marriage” to see whether a marriage is relatively healthy, even if it is disappointing.

Leslie also suggested to her readers how to initiate change in their marriages. In this section she gave advice on how to Learn to Speak up in Love, to Stand Up Against the Destruction; what to do When There is No Obvious Change. She then described some Necessary Changes for a Marriage to Heal and gave counsel on Restoring the Destructive Marriage. Each of these topics had it’s own chapter.

Her website also has a blog where she gives practical, Biblical advice for women in destructive marriages. There is an active blogging community where these women can “receive prayer, support, encouragement and wisdom” in the midst of their relationship struggles.

There are increasingly times that I really enjoy doing marriage counseling. Sometimes it feels like I am a coach to a dancing couple striving to get their routine just right. These are couples that truly want to become the husband and wife that God has called them to be. Here it is a privilege and a joy to be part of the process. I find that Leslie Vernick’s books and material are an integral part of that process.

06/13/14

Coping with Our Porn-is-the-Norm Culture

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What would you say if someone came up to you after a church service and said:

  • “Dirty, ugly, shameful, unwanted and unloved are a few of the words I’ve used to describe myself. For twenty years I have lived in the darkness of sexual addiction.”

or

  • “I was a good, Christian boy raised in a good Christian home and community, and my life didn’t look any different from the world and what it promotes sexually. . . . I knew all the Christian doctrines, but in my heart I was helpless to resist, a slave to my desires—for the next 25 years.”

or

  • “After college I “stumbled” across pornography following a broken relationship. . . . After every fall I would be crushed with guilt and shame; I would ask for forgiveness; I would feel better; and then shortly thereafter fall again.”

Could you give these three people any hope and practical help for their struggles with sexual sin? One place you could suggest is Harvest USA. In their Winter 2013 Newsletter, you can read the complete personal stories of the three people quoted above. In that same newsletter, is the Dave White and Nicolas Black article, mentioned in a previous blog post, “Our Porn-is–the-Norm Culture.”

Another helpful resource that I’ve used regularly in Tim Chester’s book, Closing the Window. Chester said that porn is providing the sex education for a generation of young people. It is establishing their expectations for sex and marriage. “We have a generation of young people for whom the call to repentance must include a call to turn from porn.”

Chester gave a helpful, biblically sound definition. Porn “is anything we use for sexual titillation, gratification or escape—whether it was intended for that purpose or not.” So looking at ads or catalogues to stimulate lust, “undressing” someone with your eyes, fantasizing about sex with someone who is not your spouse, are equally pornographic along with sexually explicit material in magazines or movies or on the Internet.

The biblical starting point for this definition of pornography is Matthew 5:27-28, “You have heard that it was said, ‘Do not commit adultery.’ But I tell you that anyone who looks at a woman lustfully has already committed adultery with her in his heart.”

Chester suggested five key ingredients that need to be in place to win the battle with porn:

  1. Abhorrence of porn—a hatred of porn itself (not just the shame it brings) and a longing for change.
  2. Adoration of God—a desire for God, arising from a confidence that he offers more than porn.
  3. Assurance of grace—an assurance that you are loved by God and right with God through faith in the work of Jesus.
  4. Avoidance of temptation—a commitment to do all in your power to avoid temptation, starting with controls on your computer.
  5. Accountability to others—a community of Christians who are holding you accountable and supporting you in your struggle.

John Freeman, the President of Harvest USA, had this to say about Closing the Window: “This is a wonderful resource to add to the arsenal of anyone serious about finding freedom from the power of pornography. . . . It is an excellent pastoral tool to help those dealing with and impacted by the false promises and lies of our porn-is-the-norm culture.”

Several years ago I had a conversation with Tim Geiger, now the Executive Director of Harvest USA, about counseling individuals struggling with sexual sin. I frankly told him of my reluctance to counsel individuals with this issue. The problems were so entrenched. The denial and resistance was so strong. This was coming from someone who has spent most of his counseling career working with addicts and alcoholics. But that reluctance faded away after I read Closing the Window. This is THE resource to read and recommend to individuals struggling with porn.

06/11/14

Our Porn-is-the-Norm Culture

“Those who argue that pornography has been with us since cavemen first drew fornicating women on earthen walls ignore the vast discrepancies between a world in which pornography was glimpsed on the sly … and today’s culture, in which pornography is omnipresent, accepted, and glorified.” (Pornified, p. 241)

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Today, according to Pamela Paul, “the entire culture has become pornified.” Paul is the author of the 2006 book, Pornified: How Pornography is Damaging Our Lives, Our Relationships, and Our Families. By pornified, Paul means that “the aesthetics, values, and standards of pornography have seeped into mainstream popular culture.”

In her essay, “From Porn to Porno to Porn: How Porn Became the Norm,” Paul noted how there has been a radical shift in the cultural landscape and social acceptance of pornography. Technology, especially with the Internet, “has made pornography more anonymous, more accessible, and more affordable than ever before.”

Porn stars are regular features in the same magazines that profile actors, singers and other celebrities. Americans rent upwards of 800 million pornographic videos and DVDs yearly. Eleven thousand porn films are shot each year, outpacing Hollywood’s yearly output of 400. More money is spent on video pornography (4 billion dollars) than on football, baseball and basketball combined.

A man rented “Smurfs 2” from a Redbox vending machine for his kids. After taking it home he discovered someone had overdubbed it with hardcore porn. Redbox said this was an ongoing problem. “This is an unfortunate incident caused by an individual with ill intent.”

Members of the American Academy of Matrimonial Lawyers reported in 2002 that 56 percent of their divorce cases involved one party having “an obsessive interest in pornographic websites. . . . 33 percent of the divorce cases cited excessive time communicating in chat rooms (a commonly sexualized forum).” The association’s president said: “While I don’t think you can say the Internet is causing more divorces, it does make it easier to engage in the sorts of behaviors that traditionally lead to divorce.”

And the statistics just keep coming. Daily Infographic indicated that twelve percent of all the websites on the internet (24,644,172) are pornographic. Every second, $3,075.64 is being spent on porn. In the US, internet porn brings in $2.84 billion per year. Worldwide, Internet porn revenue is $4.9 billion. There are 116,000 searches daily for “child pornography.” The average age at which a child first sees porn is 11; yes ELEVEN. The most popular day of the week to view porn is Sunday.

Dave White and Nicolas Black, of Harvest USA referred to the normalization of porn within the church as a silent crisis. “Pornography, which is now so widespread and accessible, seems to have become almost a non-issue for so many churches.” They mentioned a woman who said her 11-year-old daughter had been watching online porn for months. They had a call from parents saying that they discovered their 8-year-old son was watching bestiality videos on his iPod Touch.

White and Black said the church cannot afford to ignore this growing epidemic. “We must speak up… We must name the problem, proclaim that there is freedom and hope in the gospel, and patiently show our people how to manage their sexuality well.” They observed that one of the reasons for the weak and wavering faith of many in the church today may well be how “its people are capitulating to the sexualized culture and are immersed in sexual struggles and sin.” Here are some of their suggestions:

  • Sermons on sexuality and faith with real-life illustrations and strategies on an ongoing basis.
  • Adult Sunday school classes where practical strategies on how to live with sexual integrity are taught.
  • Gender-specific men’s and women’s groups that talk openly about real-life struggles in this area.
  • Youth pastors and volunteers need to be equipped to know how to help youth who are ensnared in sexual struggles and sin.
  • Parents must learn how to talk about sexuality to their kids and given tools to protect them from the dangers of unfiltered Internet usage on tablets, smartphones and iPod Touches.
06/9/14

The Dark Side of a Pill to Cure Addiction

On December 23, 2013, The Wall Street Journal published an article with the provocative title: “A Pill to Cure Addiction?” The article was generally upbeat and positive about the research done at the Scripps Research Institute in La Jolla, California—a well known and reputable research institution. The original research article, “Gabapentin Treatment for Alcohol Dependence” is available in JAMA Internal Medicine. A news release by The Scripps Research Institute, “Clinical Trial Indicates Gabapentin Is Safe and Effective for Treating Alcohol Dependence,” is available on their website.

The study found that “gabapentin significantly improved the rates of abstinence and no heavy drinking.” In the placebo group, the abstinence rate was 4.1%, 11.1% in the 900mg dose group, and 17.0% in the 1800mg dose group. The no heavy drinking rate was 22.5% in the placebo group, 29.6% in the 900mg dose group and 44.7% in the 1800mg dose group.  See the JAMA Internal Medicine abstract for the above data. The subjects who took the highest dose of gabapentin either stopped drinking altogether (17%) or refrained from heavy drinking (45%).

Barbara Mason, the lead researcher, reported in the Scripps Research Institute news release that the high-dose group refrained from heavy drinking twice as often (45% to 23%) and entirely abstained four times as often (17% to 4%) as the placebo group. Patients who received the lower, 900mg dose of gabapentin showed intermediate benefits. She concluded: “I think that we can now have confidence in the pharmacological effect of this drug.”

The WSJ article reflected this positive, upbeat attitude towards gabapentin as a treatment alternative for alcoholism. It also elaborated on the neurochemical mechanism gabapentin is theorized to influence—the brain’s stress response system—specifically CRF (corticotropin-releasing factor). Alcohol or drug use is thought to trigger the brain’s release of CRF in order to help the brain return to normal after the heightened sensation of pleasure from the chemical high. So years of drinking or drug taking are thought to make the brain more sensitive to CRF.

CRF is sometimes referred to as a “misery neurotransmitter.” It is thought to cause the anxiousness felt by addicts, which they “treat” by drinking again or taking more drugs. It also is believed to play a role in the difficulties that alcoholics and addicts have when trying to quit, particularly during situations that heighten feelings of tension and stress.

The neurochemical research into CRF and CRF-related neurotransmitters has an exciting and promising future into this so-called “dark side of addiction.” It seems to have something to say about the acute withdrawal and post acute withdrawal symptoms alcoholics and drug addicts must wrestle with and overcome to establish abstinence. But there is a dark side to gabapentin, the drug proposed to treat this dysregulation of the brain’s stress response system.

A previous blog, “Twentieth Century Snake Oil,” related the sordid, illegal history of how gabapentin became such widely prescribed drug for not just epilepsy and pain, but a slew of non-approved uses such as: anxiety, post traumatic stress, headaches and insomnia. In 2008 the FDA also mandated that anticonvulsant drugs such as gabapentin carry warning labels about the increased risk of suicidal thoughts and behaviors.  A 2010 study confirmed that gabapentin and other anitconvulsants could be associated with an increased risk of suicidal acts or violent deaths.

An article in Psychiatric Times, “The Link Between Substance Abuse, Violence, and Suicide,” indicated that individuals with a substance use disorder are almost six times more likely to report a lifetime suicide attempt than those without a substance use disorder. Emerging research also suggested that a greater severity of recent drinking is associated with the greater likelihood of suicide attempts and successes. Co-occurring alcohol and drug use may also predict a greater likelihood of suicide.

The study by the Scripps Howard Research Institute did not report any serious side effects among the treated patients. But was the presence of serious side effects actively assessed within the study or were they simply noted if reported by the subjects? It should also be pointed out that within the group with the most promising response to the gabapentin treatment, 38% of the subjects were still drinking heavily while using high doses of gabapentin; and another 45% were drinking to some extent while using gabapentin. This alone is clearly contraindicated in the FDA approved Medication Guide for Neurontin (gabapentin).

Medication assisted forms of recovery are all the rage in addiction treatment and research these days. My fear is that well meaning researchers and clinicians could be putting the very people they seek to help at risk with the solutions they propose. This study does not alleviate that fear. Let’s stay tuned for future developments.

06/4/14

Twentieth Century Snake Oil

My wake up call to the deceptive practices of some pharmaceutical companies came when I read The Truth About Drug Companies by Marcia Angell in 2004. Angell speaks credibly to the issue since she is a former editor-in-chief of the prestigious The New England Journal of Medicine. One example that stayed with me over the years because of its sheer, incredible audacity was how Neurontin was made into a multi-billion dollar selling drug.

In 1994 Neurontin was approved by the FDA as a secondary treatment for epilepsy—to be used when patients failed to respond to other anti-seizure drugs. The patent was due to expire in 1998 (it eventually received a two year extension). So the company began to target doctors to prescribe it for unapproved, off-label uses, “mainly common but vague conditions like pain and anxiety, and also as the sole treatment for epilepsy.”

Although doctors are legally permitted to prescribe an FDA approved drug for any use whatsoever, it is illegal for a drug company to market a drug for off-label uses. According to Angell, what Parke-Davis did was to pay academic experts to put their names on flimsy research papers that showed the drug worked for certain off-label conditions. This “research” typically fell below the standard required by the FDA for an approval of the drug for a particular condition.

Angell said the studies were small and poorly designed. “Some of the articles contained no new data at all, just favorable comments about Neurontin.” Parke-Davis hired medical education and communication companies to prepare the articles and paid academic researchers to put their names on the articles as authors. Once the articles were published in academic journals, “medical liaisons” would visit doctor’s offices to answer questions about the research.

Parke-Davis also sponsored educational meetings and conferences. The “authors” of the papers would describe the positive results of the drug’s off-label uses. Not only were the speakers paid, “but often the doctors in the audience were paid” as consultants. This was to get around the anti-kickback laws. “Consultant meetings were sometimes little more than vacations for potential high prescribers of Neurontin.”

The result was Neurontin becoming a blockbuster drug, with over 2 billion in sales for 2003. “About 80 percent of prescriptions that year were for unapproved uses—conditions like bipolar disorder, post-traumatic stress, disorder, insomnia, restless legs syndrome, hot flashes, migraines, and tension headaches.” In fact, Neurontin became an all-purpose restorative for chronic discomfort. An internal company e-mail described Neurontin as “the ‘snake oil’ of the twentieth century.”

A generic version of Neurontin (gabapentin) went on sale in August of 2004. The website Drugs.com reported that Neurontin sales in 2004 were approximately $2 billion dollars. In 2005, sales dropped to $259.4 million. It dropped from the 10th best selling drug in 2004 to the 123rd best selling drug in 2005. By 2006, Neurontin had dropped out of the top 200 best selling drugs.

In May of 2004 the pharmaceutical manufacturer Warner-Lambert, of which Parke-Davis was then a division, agreed to pay $430 million to resolve criminal charges and civil liabilities in connection with its “illegal and fraudulent promotion of unapproved uses” for Neurontin. See the Department of Justice announcement here. Part of the global agreement was that Pfizer, Inc., the owner of Warner-Lambert since June of 2000, agreed to training and supervision of its marketing and sales staff to ensure that “any future off-label marketing conduct is detected and corrected on a timely basis.”

In December of 2013, the U.S. Supreme Court upheld a $142 million award to the Kaiser Foundation Health Plan by Pfizer for marketing Neurontin for unapproved uses. The court also allowed two other lawsuits against Pfizer to proceed. A key factor in the court’s decision apparently was an analysis by Meredith Rosenthal of the Harvard School of Public Health. “Her analysis found that marketing Neurontin for such unapproved uses as bipolar disorder, neuropathic pain and migraines caused physicians to write 43 million off-label prescriptions.” She further calculated that 99.4 percent of the prescriptions for bipolar disorder were caused by illegal marketing.

The two outstanding lawsuits noted above now seem be settled. In April of 2014 Pfizer agreed to pay $190 million to settle a lawsuit that was first filed in 2002.  The lawsuit claimed the pharmaceutical company took several steps to delay the entry of Neurontin into the generic drug market. According to a Reuters news article, along with other delay tactics, Pfizer allegedly filed “sham patent infringement lawsuits.” And just announced on May 30th, 2014 in this report by Bloomberg, Pfizer agreed to pay $325 million to settle a lawsuit brought by health-care providers claiming that Pfizer marketed Neurontin for unapproved uses. In both settlements, Pfizer did not admit to any wrongdoing.

So why does the history of unapproved marketing of Neurontin (gabapentin) rent so much space in my head and this blog? The Wall Street Journal recently ran an article titled “A Pill to Cure Addiction?” on “new medicines” that are being tested to help people quit drug and alcohol habits. The “new drug,” touted as a possible cure for addiction, is gabapentin.