11/25/15

Drugs, Violence and Revolution

The recent killings in Oregon at Umpqua Community College by Chris Harper Mercer have again brought the issue of violence and mental health into the news. But there is an element in the narrative that is often missing in media reports of the incidents. Many of the shooters, if not all, were taking psychiatric medications or had recently stopped taking their medications at the time of the shootings. The misdirection of the spin on these incidents has largely been to argue for increased gun control or to press for more screening for mental health problems and to increase forced treatment—meaning increased forced medication.

Writing for The New American in March of 2013, Rebecca Terrell (“Psychiatric Drugs: Prescription for Murder?”) noted ten examples of young people who were the perpetrators of mass school shootings and who had a history of taking psychotherapeutic drugs. Terrell described an incident in 2001 where a 16 year old held a high school class hostage at gunpoint in Washington State. No one was killed or hurt physically. But he has no memory of the incident. “In the morning I didn’t feel like going to school. I felt sick; didn’t feel like I could get up very well. So I went back to bed. And the next thing I remember I’m in juvie in the detention center where I used to live.” He received a reduced sentence because expert psychiatric testimony convinced the jury his crime was the result of adverse effects from Effexor and Paxil.

We can add Mercer to Terrell’s list. C. Mitchell Shaw and Peter Breggin noted that Mercer was taking several medications, including antidepressants. Shaw reported that Mercer’s mother had him admitted to a psych unit because he quit taking his medications. Breggin posted a screen shot of Mercer’s Facebook page where he said: “I have a pill bottle with like five types of pills mixed in. I don’t know which ones are the sleep aids, so I just took four of each.” Breggin said that the major news media surely had access to the information on Mercer’s website, “but universally has chosen to withhold it.”

Shaw acknowledged that anecdotes are not proof and most people who take antidepressants do not become violent. “The fact remains, though that young people are particularly at risk of developing violent tendencies, suicidal tendencies, or both while taking these drugs.”

Dr Breggin has been a medical expert in the case surrounding Eric Harris (one of the Columbine shooters) and James Holmes (the Aurora movie theatre shooter). He said that Harris was taking Luvox (fluvoxamine) for a year before the incident. This was before and during the period of his “growing manic-like violent state.” He also had a therapeutic level of Luvox in his system on autopsy. Holmes was prescribed Zoloft by his psychiatrist, whom he told he was having very violent feelings, but did not want to fully describe them to her.

Over 120 days, he became more violent on Zoloft and began elaborately planning the assault on the movie theater. He stopped taking the drug 20 days prior to the shootings, but by then he was grossly psychotic, again in a manic-like state.

Breggin, Shaw and Philip Hickey all noted a newly published study indicating a link between SSRIs and violence, “Selective Serotonin Reuptake Inhibitors and Violent Crime.” Hickey and Breggin also mentioned a study from 2010, “Prescription Drugs Associated with Reports of Violence towards Others.” The 2010 study looked at all the reports of violence reported to the FDA Adverse Event Reporting System (AERS). The other study, which was just published in September of 2015, is a retrospective study of 18 to 25-year-olds on SSRIs. Breggin said the implications of these two studies are enormous.

“Prescription Drugs Associated with Reports of Violence towards Others” showed that “serious acts of violence were regularly reported as an adverse drug event.” Chantix (varenicline), a smoking cessation medication, had the strongest association with violence. Antidepressants showed a consistently elevated risk of violence. See Table 1 in the study for data on drugs associated with violence. See Table 3 for data on the reported incidents of violence and adverse events for psychotropic drugs. The authors concluded:

These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and serotonin reuptake inhibitors were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.

“Selective Serotonin Reuptake Inhibitors and Violent Crime” extracted information on SSRIs prescribed in Sweden between 2006 and 2009 from the Swedish Prescribed Drug Register and information’s on convictions for violent crimes for the same time period from the Swedish national crime register. Their findings showed an association between SSRIs and violent crime that varied by age group. This did not prove a causative relationship between SSRIs and violent crime among young people. Nevertheless, “the association between violent crimes and SSRIs among individuals younger than 25 years is worrying.”

There are two principal clinical implications arising from this study. First, no association between SSRIs and violent crime convictions was found for the majority of people who were prescribed these medications, including individuals aged 25 y and older. Second, the risk increase we report in young people is not insignificant, and hence warrants further examination. If our findings related to young people are validated in other designs, samples, and settings, warnings about an increased risk of violent behaviours while being treated with SSRIs may be needed.

In “Psychiatric Drugs and Violence,” Hickey observed that while both studies indicate a link between SSRIs and violence, they have limitations that make it difficult to draw firm conclusions. So further research is needed into the association. There is a petition on We the People asking to launch a federal investigation into the relationship between school shootings and psychiatric drugs. Hickey said that one of psychiatry’s most obvious vulnerabilities is how various antidepressants induce homicidal and suicidal feelings and actions in some individuals, especially late adolescents and young adults. “This fact is not in dispute, but psychiatry routinely downplays the risk, and insists that the benefits of these drugs outweigh any risks of actual violence that might exist.”

Amazingly, psychiatry has consistently failed to conduct a comprehensive, prospective, formal research study on this matter, even though the need for such a study has been glaringly evident for almost 20 years. It is very difficult to avoid the conclusion that psychiatry’s refusal to engage this question is motivated by a desire to suppress information, and to avoid the anti-psychiatry publicity that such a study will almost surely entail.

Perhaps psychiatry avoids research into the connection between violence and psychiatric medications to avoid the catastrophe of thousands or millions of individuals going off their psychiatric medications. The adverse effects of this could include an epidemic of self-harm or violence to others by mentally unstable individuals off their meds. So the paradox here is self-harm and violence is avoided by failing to investigate the connection between medication and violence. If this is the rationale of psychiatry, I think Thomas Kuhn’s idea of a paradigm shift in psychiatry applies.

In The Structure of Scientific Revolutions, Thomas Kuhn sees science as alternating between normal and revolutionary phases. Within periods of normal science, a paradigm provides the framework within which scientific work was conducted and evaluated. This view of science sees it as largely consensus-based around a reigning paradigm. Psychiatry fits this view of science to a “t.” Its heart is a consensus-based diagnostic system.

According to Kuhn, a paradigm is “the universally recognized scientific achievements that for a time provide model problems and solutions to a [scientific] community of practitioners.” (The Structure of Scientific Revolutions, viii) Normal science is largely “puzzle-solving” activity—figuring out how to apply the paradigm to new phenomena. “During periods of normal science the shared paradigm serves to define the relevant discipline, … to define what are legitimate scientific problems, to define what are acceptable solutions to problems, and to guide research into new lines of research.”

Occasionally, a result that is contrary to what the paradigm expects—an anomaly—occurs. Since biological psychiatry sees itself as scientific, evidence that medications contribute to violence and self-harm when they are supposed to lessen violence and self-harm is seen as an anomaly. Anomalies are either ignored or explained away if at all possible, according to Kuhn. When there are enough anomalies that defy resolution by the paradigm or when the anomaly involves something so central to the paradigm that it cannot be ignored, a crisis state develops. This is what I see happening to psychiatry. It is in this crisis stage.

If there is an acceptable alternative paradigm available, the new paradigm replaces the old one (a revolution occurs) and a new period of normal science begins with the new paradigm. Kuhn did not presume that a new paradigm would triumph over an older one because of its improved explanatory power. Rather like religion, “The transfer of allegiance from paradigm to paradigm is a conversion experience that cannot be forced.”

Kuhn’s thought it still helpful for anyone opposed to seeing psychiatry as scientific. In an essay he wrote in the early 1960s, “The Function of Measurement in Modern Physical Science,” Kuhn observed that the social sciences were largely in a pre–scientific stage. He said this was because most of the social sciences were still “characterized by fundamental disagreements about the definition of the field, its paradigm achievements, and its problems.” (The Essential Tension, 222) This lack of consensus still largely applies to psychiatry and indicates it is still within a pre-scientific stage. To name but a few of the disagreements, there are disputes over conceptualizing and defining “mental illness,” whether electro convulsive therapy is treatment or torture, and whether the wide-spread use of psychiatric medication been an achievement in treatment or has it caused an epidemic of mental illness.

The effort made by psychiatry to present a united front and to ignore its anomalies like the connection between violence and psychiatric medications indicates it has an entrenched view of what it does as scientific. So be it. Let’s not waste time trying to convince its thought leaders of their error. But let’s continue to present information to the consumers of psychiatry on its anomalies and bankrupt theories. If people no longer believe in psychiatry and its views of how to handle problems in living, it will either have to radically change or be toppled from its position of authority. Let’s work for both options. Long live the revolution.

11/18/15

The Cycle of Antidepressant-Induced Helplessness

© Everett Collection, Inc. | dreamstime.com

Lawyers for GlaxoSmithKline (GSK) recently referred to evidence presented by a well-respected expert, Dr. Joseph Glenmullen, as “junk science.” He was irrational enough to testify that there was a connection between suicidality (the likelihood of an individual completing suicide) and suicide attempts. The case is one where the widow of a lawyer sued GSK because her husband committed suicide shortly after taking a generic version of the antidepressant. “Since there is no way Dr. Glenmullen can establish causation based on suicide data, he relies instead on data on ‘suicidality’ and suicide attempts, which are not appropriate surrogates for reaching conclusions about suicide.”

The above was taken from a brief news report on Mad in America, “Paxil Manufacturer Calls Evidence of Suicide Risk ‘Junk Science.’” The article said GSK has routinely overstated the drug’s efficacy. A widely cited 2001 study funded by GSK known as “Study 329” was recently reanalyzed and these results then published in the British Medical Journal. The reanalysis showed that the original claim by Study 329 that Paxil (paroxetine) was safe and effective for adolescents was wrong. The September 16, 2015 BMJ press release also noted where GKS had been fined $3 billion ($1 billion criminal, $2 billion civil) for fraudulently promoting paroxetine, among other violations.

Using previously confidential documents, researchers reanalyzed the original data from Study 329 and found that paroxetine was not more effective than placebo in treating major depression in adolescents. They concluded: “paroxetine was ineffective and unsafe in this study.” And yet for fourteen years Study 329 has been cited as demonstrating the safety and efficacy of paroxetine to treat adolescent depression. The BMJ Editor-in-Chief said the publication of the reanalyzed data “set the record straight” while it also “shows the extent to which drug regulation is failing us.”

All antidepressant medications are required to include a warning similar to what follows, which was taken from the Medication Guide for Paxil:

PAXIL and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

Psychiatrist Peter Breggin noted in “The Proven Dangers of Antidepressants” that the FDA warning cautioning about the risks of newer antidepressants (Prozac, Zoloft, Paxil, Luvox, Celexa, and Lexapro, as well as Wellbutrin, Effexor, Serzone, and Remeron) followed a public hearing with dozens of family members and victims testifying about suicide and violence committed by individuals taking these medications.

While stopping short of concluding the antidepressants definitely cause suicide, the FDA warned that they might do so in a small percentage of children and adults. In the debate over drug-induced suicide, little attention has been given to the FDA’s additional warning that certain behaviors are “known to be associated with these drugs,” including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania.

Breggin was himself an expert witness in a 2012 court case that awarded $1.5 million medical malpractice verdict to a family of a man who committed suicide. He testified how antidepressants such as Paxil and Effexor could increase suicide risk in adults.

After reviewing extensive records and interviewing Mr. Mazella’s wife Janice, I concluded that Dr. Beals was negligent in reportedly prescribing Paxil for 10 years without seeing the patient, in failing to warn the patient and his wife about the serious risks associated with Paxil, in his doubling the Paxil dose and adding Zyprexa by telephone, and then in abandoning the patient during his decline. I also concluded that a hospital psychiatrist was negligent in not recognizing that Mr. Mazella was suffering from adverse drug effects and in discharging him without proper follow up two weeks before his death.

In his discussion on “The Proven Dangers of Antidepressants” linked above, Breggin also commented how there has been little attention to the additional FDA warning that additional behaviors are known to be associated with antidepressants, including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania.” He noted how he has repeatedly documented how the stimulation and activation profile of antidepressants can lead to out-of-control behavior, including violence.

In his article, “Antidepressant-Induced Mania,” psychologist Philip Hickey described how circular reasoning about activation from antidepressants becomes evidence of “an underlying latent bipolar disorder.” He indicated that psychiatry retrospectively applies their explanation as follows: “Before the individual showed any signs of mania, he must have had bipolar disorder because he became manic at a later date.” The hypothesis cannot be verified because the occurrence of a manic or hypomanic episode is the primary criterion for the bipolar diagnosis.

Yet there has been recent evidence that manic/hypomanic episodes can be caused by the use of antidepressant medications. Hickey reviewed a Psychiatric Times article written by Ross Baldessarini that reported on a meta-analysis that he and his colleagues did on antidepressant-associated mood-switching. Bipolar disorder is often seen as beginning with at least one episode of major depression, followed by an episode of mania or hypomania. This ‘switching’ of mood may occur during treatment with an antidepressant or other mood-elevating agent. And it is especially common among juveniles and young adults using an antidepressant for a mood disorder (depression or anxiety) or a stimulant for attention. “Such pathological shifts of mood and behavior may represent adverse drug actions or a manifestation of undiagnosed bipolar disorder.”

Hickey noted that Baldessarini et al. found that manic or hypomanic episodes were 5.6 times more common per year for individuals diagnosed with major depression who were taking antidepressants and others with the same diagnosis who were not taking them. After citing several quotations from the Baldessarini et al. study and the Psychiatric Times article, Hickey said: “What the authors are pointing out here is that antidepressants are clearly implicated in the ‘excess’ incidents of mania/hypomania, and they have even raised the question of a direct causal link.”

Baldessarini even suggested that when antidepressant-related manic episodes occur, the continued use of antidepressants might contribute to recurrent manic episodes. Although it is widely assumed that mood-stabilizing drugs are highly effective in preventing antidepressant-associated mood switching, it is not conclusively proven to be true. “Moreover, there is very limited evidence that prolonged antidepressant treatment provides substantial protection against recurrences of bipolar depression and that it might contribute to emotional instability or rapid cycling.”

When you add the research of Irving Kirsch, who has shown that antidepressants have little or no therapeutic effect at all (See “Do No Harm with Antidepressants”), we are left with a class of drugs that are no more effective than the placebos used in their clinical trials. As we saw here, they could also activate what they are taken to prevent or stabilize—depressive symptoms such as suicidality. Moreover, their use could also lead to mania or hypomania and thus elevate the initial diagnosis of major depression to the more serious one of bipolar disorder. And the icing on the cake is that if antidepressants are continued, they may contribute to further emotional instability or rapid cycling. This is a cycle of what Peter Breggin called iatrogenic helplessness generated by antidepressants. Here is his description in Brain-Disabling Treatments in Psychiatry:

The concept of iatrogenic helplessness and denial includes the patient’s and the doctor’s mutual denial of the damaging impact of the treatment as well as their mutual denial of the damaging impact of the patient’s underlying psychological and situational problems. Overall, iatrogenic helplessness and denial accounts for the frequency with which psychiatry has been able utilize brain-damaging technologies, such as electro-shock and psychosurgery, as well as toxic medications.

Iatrogenic refers to something induced inadvertently by a physician, medical treatment or diagnostic procedures. Breggin has been challenging the iatrogenic nature of psychiatric treatment for essentially his entire professional career as a psychiatrist. In 1983 he wrote in The Iatrogenics Handbook that iatrogenic denial involved the infliction of brain damage and dysfunction upon the patient to encourage them to deny both the existence of his problems and the iatrogenic brain damage. “I developed the brain-disabling hypothesis which states that all the major psychiatric treatments disable the normal brain rendering the individual more helpless and hence easier to manage or to ignore.”

11/11/15

Trick or Trick

A grocery store pharmacy in Quebec Canada was giving out psychiatric drugs for Halloween treats this year. A mother accidentally dropped divalproex (Depakote) and quetiapine (Seroquel) pills that she had picked up for her son. Other customers picked up the pills, which were wrapped in a blister packet, and placed them on the counter next to a candy basket. Somehow the pills were mixed in with the candy. “Seven of the pills ended up in the hands and bags of trick-or-treating children.”

A Constable said that an employee mixed the medications in with the candy by accident. But one mother said she immediately recognized the pills were drugs and took them away from her daughter who had “chewed and spat out the drugs distributed by mistake.” The “mistake” is puzzling, as the girl’s mother said: “It was a transparent bag, with the name of the person, the drug, the dosage, the pharmacist and the date and time the prescription was filled; October 31 at 8 a.m. in the morning,”

Police told parents that the pills weren’t dangerous, but that is just not true. The medication guide for quetiapine lists potential side effects as: the risk of suicidal thoughts or actions, depression, anxiety, panic attacks, irritability, anger or aggression, unusual changes in mood or behavior. The medication guide for divalproex lists similar potential side effects: the risk of suicidal thoughts or actions, depression, anxiety, agitation or restlessness, anxiety, irritability, anger or aggression, unusual changes in mood or behavior. And it can cause serious liver damage in children younger than 2 years old. Granted, these adverse effects would in all probability not occur if a child had wrongly ingested one pill, but the describing the pills as not dangerous was deceitful. Read more on this incident at The Fix or Vice.

Seroquel is an antipsychotic medication and Depakote is an anti-seizure medication that carries the label of “mood stabilizer” when used as a psychiatric medication. Antipsychotics are frequently combined with mood stabilizers in the treatment of bipolar disorder. A September 2105 study published in JAMA Psychiatry, “Treatment of Young People with Antipsychotic Medications in the United States,” examined at the prescription patterns among young people in the United States. The study looked at four age groups: younger children (1-6 years), older children (7-12 years), adolescents (13-18 years), and young adults (19-24 years).

The researchers found that most of the individuals treated with antipsychotics did not have a medical claim that included a mental disorder diagnosis. The percentages by age group were as follows: younger children (60.0%), older children (56.7%), adolescents (62.0%), and young adults (67.1%). When there was a diagnosis, the most common one was ADHD with younger children (52.5%), older children (60.1%) and adolescents (34.9%). Depression was the most commonly given diagnosis among young adults (34.5%).

Consistent with clinical diagnoses suggesting that antipsychotics are primarily used to manage impulsive or aggressive behaviors in children associated with ADHD, the highest rate of antipsychotic treatment was in adolescent boys, approximately half of whom also filled prescriptions for stimulants. Young adults treated with antipsychotics were more frequently diagnosed as having depression, bipolar disorder, and anxiety disorder than ADHD.

A National Institute of Mental Health (NIMH) press release on the study, quoted a co-author, Michael Schoenbaum, as saying antipsychotics should be prescribed with care. “They can adversely affect both physical and neurological function and some of their adverse effects can persist even after the medication is stopped.” He added what was particularly important about the study’s findings was that 1.5% of boys aged 10-18 are on antipsychotics. This rate was abruptly cut in half as adolescents become young adults.

In the current study, the combination of peak use of antipsychotics in adolescent boys and the diagnoses associated with prescriptions (often ADHD) suggest that these medications are being used to treat developmentally limited impulsivity and aggression rather than psychosis.

Mad in America quoted Dr. Christopher Correll, the medical director of the New York State Office of Mental Health, who noted that the powerful and almost immediate problems with antipsychotics can include weight gain and high glucose levels (a possible precursor of diabetes). “Prescribing antipsychotics seems predominantly aimed at aggressive and impulsive behaviors, especially in males, where the disruption in school and home insists on action and remediating symptoms.”

The study commented how the above noted decrease in prescribed antipsychotics after adolescence may be due to the normal maturation of neurobiological systems in late adolescence and early adulthood. “This normal maturation of neurobiological systems may underlie the decrease in antipsychotic treatment prevalence during late adolescence among youth who do not have enduring cognitive impairments and long-term severe behavioral disorders.” High rates of coprescribing antipsychotics with other classes of drugs were observed across all age groups. Stimulants (probably for ADHD) were the most commonly prescribed psychotropic class during preadolescent years.

A likely outcome in these cases is that agitation from the ADHD stimulants contributes to an increase in aggression among preadolescents, which results in the prescription of an antipsychotic to address the aggression. Dr. Peter Breggin said: “The antipsychotic drugs are often given to children when their behavior and mental state deteriorates as a result of being given stimulants.” Follow the link here to a page on his website where he discusses the potential harm from the psychiatric diagnosing and drugging of children. The page includes links to several videos in his Simple Truth series on YouTube that address topics such as: the harmful effects and action of stimulant drugs; and the negative effects of diagnosing children with ADHD. There is also a link to one of his articles published in Children & Society that “presents a scientific and ethical overview of the harm done to children by stimulants and by antipsychotics.”

The drugging of children in America and increasingly throughout the world is a tragedy. Millions upon millions of children and youth will never know their full potential because they grew up with an intoxicated brain — their neurotransmitters forever deformed by being bathed in these drugs during their formative years. Additional millions will become career consumers of psychiatric drugs with a vastly reduced quality of life and shortened lives.

03/11/15

Lair, Liar Pants on Fire

Okay, well perhaps TECHNICALLY Janssen Pharmaceuticals, a division of Johnson and Johnson (J&J) didn’t lie about Risperdal to the public. But thousands of recent lawsuits have charged that there is a troubling side effect in young men who take the medication: gynecomastia. That means it can trigger abnormal breast growth in the males who use the drug.

Mad in America reported that the law firm of Pintas and Mullins (linked above) reported that there were 1,250 pending cases against J&J (most of which are related to abnormal breast growth) out of which six were selected as “bellweather” trials in 2012. However, Janssen agreed to settle those cases before they went to trial. Janssen also agreed to settle another 80 cases in early 2013. Historically, this has been a regular legal tactic of pharmaceutical companies when they are sued. Peter Breggin has noted how this method and others were used by pharmaceutical companies to neutralize potentially damaging lawsuits against them; and keep the information they contained from becoming public knowledge.

But that doesn’t always work. Pintas and Mullins, Mad in America, Peter Breggin and FiercePharma have reported on past settlements made by Janssen for misleading statements about Risperdal. In November of 2013 Janssen agreed to pay a $2.2 billion settlement with the federal government for false claims over Risperdal. The company pled guilty to illegally promoting the off-label use of Risperdal with the elderly suffering with dementia or Alzheimer’s in nursing homes. Janssen also settled off-label marketing claims with 36 states and the District of Columbia over Risperdal for $180 million; then with Texas for another $158 million. So I suppose we could say that Janssen was found guilty of lying about Risperdal in these off-label marketing cases.

Recent cases include a lawsuit argued in Philadelphia regarding a 20-year-old man with autism, who took Risperdal to help with irritability caused by his autism. He began taking the drug as an eight-year-old, despite the fact it was only approved for use with adults at that time. FiercePharma reported that the man’s then pediatric neurologist, Jan Mathisen, said sales reps from Janssen had distributed Risperdal samples twenty times between 2002 and 2004, 5 years before the drug was approved for use in autistic children. After a day in court, the autistic man’s mother tearfully said that she was having a difficult time after “Hearing what the pharmaceutical company was doing.”

Janssen claimed that the company’s warnings were complete and proper, and that it did not miss-market the drug. In a statement provided to Blooomberg Business, a Janssen spokesperson claimed that Risperdal “has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients’ quality of life today.”

Janssen claims that Risperdal’s labels always included warnings of the risk of gynecomastia in adults, and notified doctors that it was not proven safe for use in children. The Pintas and Mullins article said the company claims that the doctor who prescribed Risperdal to the autistic man should be held at fault. In addition,

Janssen is accused not only of illegally marketing Risperdal, but also of paying doctors to speak favorably of the drug. The company paid for gold outings and other flashy incentives to get doctors to prescribe the drug to patients just like the eight-year-old in Alabama. Many of those boys taking Risperdal grew breasts and had to undergo mastectomies.

A former FDA commissioner, David Kessler, testified in Philadelphia that Johnson and Johnson knew as early as 2001 that Risperdal could cause boys to grow breasts—a full five years before the company added the warning about the potential side effect to the drug’s official label. In support of his claim, Kessler pointed to a 2001 study, FUNDED BY J&J that indicated 3.8% of boys using Risperdal in a clinical trial developed breasts. He commented that the study should have been a red flag to the company. According to Bloomberg, the neurologist Mathisen said in his testimony that he would have liked to have known about the study.

A J&J lawyer said that Kessler was a biased witness or “hired gun” because he commonly testified in drug-safety trials since leaving the FDA in 1997 (see articles here and here). She suggested that he was “cutting and pasting” findings from other cases into his conclusions that: 1) officials at Janssen knew Risperdal caused some boys to develop breasts and 2) failed to alert patients, doctors and regulators about it. Kessler disputed her claims saying, “Each case is complex and there is an enormous amount of details associated with them . . . . To say I’ve testified each and every time the same way would be incorrect.” He also indicated where he has testified on behalf of pharmaceutical companies in the past.

As I first wrote this, the trial in Philadelphia was scheduled to take another few weeks. I was rooting for a ruling in favor of the autistic man and his family, which did happen! The Wall Street Journal reported that a Philadelphia jury decided Johnson & Johnson had to pay $2.5 million in damages for failing to warn that Risperdal could cause gynecomastia. The attorney representing the autistic man said: J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted.”

The settlement is relatively modest, considering what J&J has made from Risperdal. In the seven years between 2003 and 2010, Risperdal grossed more than $24 billion worldwide; 4.5 billion in 2007, the year it went off patent. While there should be enough capital to settle the case without J&J going bankrupt, with the additional 1,200 plus lawsuits, it may be a good time to divest yourself of J&J stock.

01/21/15

The Frankenstein Monster of ECT

In his article on electricity and 19th century medicine, Dr. Matthis Krischel argued that Mary Shelley’s novel, Frankenstein, could be read as a Victorian science fiction novel that sought to imagine the medical possibilities of electricity. In the era where the scientific method was established within the biomedical sciences, Shelley’s novel raised the question of what the experimenter could ethically do to living, as well as dead bodies. That very same question continues to be debated today over the use of ECT (electroconvulsive therapy) to treat depression.

Krischel asked what physicians can learn from 19th century’s medical experiments with electricity. He commented that like the early 19th century, new technologies and therapies can instill fear in the public or individual patients. “Medical practitioners must take these reactions seriously and address them as well as use the tools of their trade responsibly in order not to turn loose another Frankensteinian monster.”

When reading the literature critical of ECT, I had an eerie déjà vu experience of Krischel’s description of the 19th century experiments with electricity in medicine. Philip Hickey reviewed an article by Max Fink, a supporter of ECT, celebrating 80 years of convulsive therapy. Even a mostly positive history of ECT written by Norman Endler in 1988, “The Origins of Electroconvulsive Therapy (ECT)”, acknowledged that ECT was controversial. The nature of ECT treatment, its history of abuse, unfavorable media presentation (Think “One Flew Over the Cuckoo’s Nest”), and compelling negative testimony by former patients paints a Frankenstein-like atmosphere at times.

Disturbingly, in “ECT: shock, lies and psychiatry,” Yvonne Jones and Steve Baldwin reported that during the very first ECT experiment on a human, the patient’s very clear objections were ignored. “Despite the man’s expressed wishes, Cerletti proceeded with his experimentation, and using a higher voltage, induced a convulsion.”

Peter Breggin has been a long time activist against ECT, going back to before his 1979 book, Electroshock. Dr. Breggin made this book, along with more than 125 scientific articles on injury from ECT, available on his ECT Resources Center website. He has also provided links to information on ECT from other sources, including his website, blogs and scientific articles he’s written.

In a 2010 article on ECT, Breggin noted that ECT therapy, and “the machines that deliver it,” have never been tested by the FDA for safety and efficacy. He gave an overview of several disturbing findings with ECT.

The “treatment” process of ECT delivers sufficient trauma to the brain to cause a severe grand mal seizure. “There can be no scientific doubt that ECT harms the brain and mental function. The only controversy surrounds the severity and persistence of the harm.”
New evidence (here and here) confirms that ECT produces lasting memory dysfunction and other cognitive deficits. It contradicts claims by shock advocates “that ECT does not cause brain damage.”
ECT is frequently used with the elderly, where it causes even more severe dysfunction to the fragile, older brain.
Despite several decades of effort, no lasting improvements from ECT can be demonstrated. “The Consensus Development Conference on ECT found that controlled clinical trials failed to demonstrate any positive effect beyond four weeks.” There’s no clear evidence of a reduction in suicide risk. Several studies have shown that a placebo ECT procedure produces as much improvement as ECT itself, “without any of the risks.”

In a 1998 article, Dr. Breggin gave an extensive review of the problems resulting from ECT treatment. One of the more disturbing ones to me was that of iatrogenic [caused by medical treatment or examination] helplessness and denial. Consistent with other individuals with central nervous system damage, ECT patients minimize or deny their real losses of mental function. Think of someone you know with dementia or Alzheimer’s. “Interviews with family and friends of patients often disclose that they are painfully aware of the damage done to their loved ones. Often, the psychiatrist is the only one who consistently and unequivocally denies the patient’s damaged state.”

At the Consensus Conference on ECT in 1985, critics and advocates debated whether there was any benefit from ECT. “The advocates were unable to come forth with a single controlled study showing that ECT had a positive effect beyond 4 weeks.” Breggin commented how this confirmed the brain-disabling principle of ECT, since “4 weeks is the approximate time for recovery from the most obvious mind-numbing or euphoric effects of the ECT-induced acute organic brain syndrome.”

Matthis Krischel correctly observed that Frankenstein could be read in a way that imagined the medical possibilities of electricity. Shelley eloquently captured the just discussed temporary mood-lifting effects of ECT:

For a moment my soul was elevated from its debasing and miserable fears to which these sights were the monuments and the remembrances. For an instant I dared to shake off my chains, and look around me with a free and lofty spirit; but the iron had eaten into my flesh, and I sank again, trembling and hopeless, into my miserable self.” (Mary Shelley, Frankenstein)

09/24/14

The Making of an American Tragedy

Psychiatrist Peter Breggin said that diagnosing millions of children with ADHD and then treating them with stimulants and other psychoactive chemicals is an American tragedy. “Never before in history has a society attempted to deal with its children by drugging a significant portion of them into conformity while failing to meet their needs in the home, school and society.” According to Dr.Breggin, the ethical scientist and physician, the concerned parent “must feel stricken with grief and dumbfounded” that our society has allowed this to happen to our children.

In October of 2011, the American Academy of Pediatrics (AAP) overrode the FDA and approved diagnosing children as young as four with ADHD and medicating them with Ritalin. The lead author of the report said: “Because of greater awareness about ADHD and better ways of diagnosing and treating this disorder, more children are being helped.” Dr. Breggin said this action was an outrage: “This endorsement of drugging younger children by the American Academy of Pediatrics is an outrage.”

According to Dr. Breggin, the scientific literature shows that 50 percent or more of children this young will become depressed, lethargic, weepy—along with being more manageable when given medications such as Ritalin, Adderall and other ADHD medications. Studies show that stimulants will permanently change brain chemistry in the children, cause shrinkage of brain tissue and predispose them to cocaine addiction in young adulthood. He also feared this endorsement by the AAP would open the door for every other psychiatric drug being prescribed to children that young.

These new guidelines will encourage prescribers to throw caution to the wind with toddlers, opening a Pandora’s box of drug intervention for children. Many young children will have their brains bathed with powerful and often toxic chemicals in the early years of their central nervous system development.

But the problems didn’t stop there. Susanna Visser, who oversees the CDC research on ADHD, presented a report at the Georgia Mental Health Forum in May of 2014 that suggested at least 10,000 2 and 3 year-olds were being medicated for ADHD. “It puts these children and their developing minds at risk, and their health is at risk.” Effective non-drug treatments were often ignored.

Families of toddlers with behavioral problems are coming to the doctor’s office for help, and the help they are getting too often is a prescription for a Class II controlled substance, which has not been established as safe for that young of a child.

As liberal as the AAP guidelines for ADHD are, they do not even address diagnosis in children 3 and younger—let alone the use of stimulant medications—with that age group. Children under 4 are not covered in the guidelines because “hyperactivity and impulsivity are developmentally appropriate for toddlers.” Dr. Lawrence Diller, a pediatrician, said: “People prescribing to 2-year-olds are just winging it. It is outside the standard of care, and they should be subject to malpractice if something goes wrong with a kid.”

Sheila Matthews attempted to put “the insanity of drugging 2-3 year olds” in perspective. She noted that the average weight for male toddlers at three years was 29.5 pounds; female toddlers averaged 28.4 pounds. “By this age, only 80 percent of the child’s brain has fully developed.” Kids at this age are learning to arrange things in groups, to put things in size order, remembering what they did yesterday, learning to say please and thank you, and recognizing themselves in the mirror. “In a nutshell, 2-3 year old toddlers are being labeled with an alleged mental illness that is not based in science or medicine and then “treated” with extremely addictive, mind-altering drugs before their brains are even fully formed.”

Psychiatrist Allen Frances said: “Treating babies with stimulants is based on no research, is reckless, and takes no account of the possible harmful long-term effects of bathing baby brains with powerful neurotransmitter drugs.” He hoped that the CDC report would fuel a backlash of parental and professional protest as it becomes clearer how absurdly overused is the ADHD diagnosis and stimulant medication. “It is also particularly outrageous that so many of the thought leaders promoting the excessive use of stimulants have such close ties with pharmaceutical companies.”

Dr Breggin lamented that instead of meeting the normal needs of our children, we are suppressing them with drugs. The average parent or teacher has no idea that what is presented as medical treatment “is actually a form of medical child abuse.” What they see is a more manageable child and assumes this is for the best. Instead, it is the making of an American tragedy.

09/10/14

Is ECT Brain Disabling?

I’ve only had a couple of up-close-and-personal experiences with people who have had electroconvulsive therapy (ECT). Both were residents of a long-term addiction treatment facility for women. One woman was in her late 20s who didn’t appear to have suffered any serious side effects after her ECT treatment. But the ECT didn’t seem to have a clearly positive effect on her depression. Actually, her mood seemed rather flattened afterwards.

The other woman had been a resident for a few months and suffered a severe depressive episode for which she agreed to have ECT. A small group of the residents gathered around her when she returned from her stay and ECT treatment at Western Psychiatric Institute and Clinic (WPIC). The other residents were supportive, asking how she was doing; telling her they were glad to see her, etc. She responded in a quiet, timid manner, thanking them for their support. As the group broke up and we entered the facility, she whispered to me: “Who were those people?”

Since then, I’ve read some of the material of the opponents to ECT, particularly Peter Breggin, who has a long history of activism against ECT. Dr. Breggin, has gathered an incredible amount of information on the website ECT Resources Center.

So I was interested when I saw an online article in the Pittsburgh Post-Gazette in December of 2013 on ECT treatment at WPIC, “Electroconvulsive therapy a surprisingly common treatment for mental illness.” The psychiatrist who treated the woman in the article said that ECT “is the most effective antidepressant still out there.” The article was clearly positive about the use of ECT, but a sentence stood out to me: “Doctors are still not sure why ECT works.” Yet, Dr. Breggin wrote on his website:

ECT works by damaging the brain. The initial trauma can cause an artificial euphoria which ECT doctors mistakenly call an improvement. After several routine ECTs, the damaged person becomes increasingly apathetic, indifferent, unable to feel genuine emotions, and even robotic. Memory loss and confusion worsen. This helpless individual becomes unable to voice distress or complaints, and becomes docile and manageable. ECT doctors mistakenly call this an improvement but it indicates severe and disabling brain injury.

A 78-year-old Beaver Falls woman, who had been treated for a bipolar disorder since the 1960s, was the featured patient in the Post-Gazette article. The reporter, Mark Roth, was permitted access to observe her ECT treatment. He wrote that she was unconscious and her muscles were paralyzed from anesthesia, “It was over in 8 seconds. . . . For her and for anyone watching, it was far less dramatic than they might have imagined.” After her series of 10 shock treatments, the woman felt that ECT helped her tremendously. She said that ECT made it possible for her to climb out of the deepest depression she had ever experienced.

The comment of ECT being “far less dramatic” was an allusion to the 1975 movie “One Flew Over the Cuckoo’s Nest,” where Jack Nicholson’s character was held down by attendants as he went through ECT treatment and the resultant seizure.

The modern use of anesthesia and muscle relaxants means that physical restraint, as portrayed in the movie, no longer occurs. But as Dr. Breggin pointed out in a debate with Dr. Helen Lavretsky, anesthesia makes it more difficult to initiate a seizure, so the patient has to have a greater shock than was given in the past. Listen here to the debate with Dr. Helen Lavretsky located on the ECT Resources Center website.

Dr. Lavretsky said that ECT was rarely performed, but Dr. Solia of WPIC, said that was a common misconception, at least at WPIC. He said that WPIC was one of the largest operations in the nation, performing “more than 300 electroshock procedures per month.” An assembly line procedure had “one set of patients being prepped with IV lines as another one is getting the treatment and still others are coming back to consciousness in a recovery area.”

There hasn’t been any follow up to the Post-Gazette article, even though the original article did say it was the “first of five parts.” In preparing my own article, I read the comments to the original article and I think I understand why. What was supposed to have been a positive public relations story about the ECT clinic at WPIC became a lightening rod that attracted strong negative attention. The majority of comments were negative like the following:

Not everyone’s ECT experiences are as positive as this article suggests. After my ECT I lost all memories of the year of my life before the treatments. This caused social and professional problems, as you can imagine, and also considerable personal pain. I also acquired some cognitive deficits with which I continue to struggle. (Sonia)I found ECT severely traumatizing, rendering profound memory loss that continues to manifest itself even 1 1/2 years later. I continue to suffer with cognitive defects and emotional pain that interfere with my work, social and personal life. I have repeatedly encountered others with very negative experiences. ECT does have positive results in some, but there are many for whom the treatment fails and wreaks havoc. (Kelly)

At least some of the individuals thought the article sounded like a “PR piece.” Cheryl asked: “Why not write another piece of equal length, focusing on the points of view medical professionals and former patients and their families who have the opposing viewpoint.” Don’t continue to wait for that to happen. I don’t think there will be any follow up articles. Just go to Dr. Breggin’s ECT Resources Center and get credible information on the problems with ECT.

07/30/14

Getting Off the Antidepressant Merry-Go-Round

I told Allison to concentrate on my voice and imitate how I was breathing. My coworker held her head in her lap. Together we kept Allison focused until the paramedics came. Determined to stop all drug use after she came into outpatient drug and alcohol treatment, she decided to stop taking her Paxil … cold turkey. The result was a severe panic attack and ER visit.

The Center for Disease Control and Prevention (CDC) estimated that eleven percent of Americans 12 and over use antidepressants. More than 60% of those taking an antidepressant medication have taken it for 2 years or longer; 14% have taken the medication for 10 years or more. Like Allison, women between the ages of 40 and 59 are those most likely to be taking an antidepressant (22.8%). Antidepressants were the most commonly used medication by persons aged 18-44; they were the third most commonly used prescription drug by all Americans in 2005-2008.

Okay, you’re thinking you want to try to withdraw from antidepressants; but you don’t want to duplicate Allison’s experience. What should you do?

First, do some research on the growing evidence of problems with antidepressants.

Look at some of the material available on the websites “ToxicPsychiatry” by Peter Breggin and PsychRights by Jim Gottstein. Here are a few recommendations.

Start with Patient Online Report of Selective Serotonin Reuptake Inhibitor-Induced Persistent Postwithdrawal Anxiety and Mood Disorders, by Carlotta Belaise, Alessia Gatti, Virginie-Anne Chouinard, and Guy Chouinard,on Psychrights. It is a short, easy to read study of online self-reports of withdrawal symptoms and postwithdrawal symptoms that they attributed to the discontinuation of SSRI antidepressants.

Then read “Do Antidepressants Cure or Create Abnormal Brain States?” by Joanna Moncrieff, found on ToxicPsychiatry. If you want further information, try her book, The Myth of the Chemical Cure. Dr. Moncrieff effectively challenges the received wisdom of the chemical imbalance theories underlying the use medications for depression, psychosis and bipolar disorder.

If you have used antidepressants for a number of years, also read: “Now Antidepressant-induced Chronic Depression Has a Name: Tardive Dysphoria,” by Robert Whitaker. Try out his website as well, Mad in America.

You can also read two articles that I’ve written and made available here on Faith Seeking Understanding: “Antidepressant Withdrawal or Discontinuation Syndrome?” and “Antidepressants Their Ineffectiveness and Risks.”

Second, become familiar with the potential postwithdrawal side effects of antidepressant withdrawal.

There is a website of free resources at RxISK. You can research reported side effects by drug name; and you can report a drug’s side effects. But be sure to look at the “Symptoms-on-Stopping Zone.” Read about the concept of medication spellbinding coined by Peter Breggin on his ToxicPsychiatry site. Try his article, “Intoxication Anosognosia: The Spellbinding Effect of Psychiatric Drugs” or his book, Medication Madness for a more detailed discussion.

Mario Fava has developed a scale to assess withdrawal/discontinuation symptoms during an antidepressant taper. You can see a copy of his DESS Scale here; and read about antidepressant discontinuation here. You can download the original Fava article here after registering with psychiatrist.com.

Finally, don’t try this at home alone.

Read this blog post on Mad in America by Monica Cassani. Locate psychiatric support groups and websites like Beyond Meds by Monica Cassani. RxISK has published a detailed “Guide to Stopping Antidepressants.” Also read Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications or Psychiatric Drug Withdrawal, both by Peter Breggin.

Make sure you have medical support and monitoring from a doctor or psychiatrist who is supportive of your attempt to taper. Someone who is president of the local chapter of NAMI and believes in the chemical imbalance theory of depression is not a good choice to supervise your drug taper. Postwithdrawal symptoms will be seen as the re-emergence of your underlying psychiatric disorder and proof you need to be on medications for life.

Tell family and friends of your decision and enlist them (those who are receptive to your decision to taper) as members of an accountability or support group. Have them read this material.

In closing, remember this warning by Dr. Peter Breggin on his website:

Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems. In short, it is not only dangerous to start taking psychiatric drugs, it can also be dangerous to stop them. Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.

05/21/14

Is ADHD Simply a Case of the Fidgets?

At a conference, I heard Bose Ravenel (a great name) describe how the “science” behind ADHD and other childhood behavioral disorders wasn’t truly scientific. I bought and read The Diseasing of America’s Children, which he co-authored with John Rosemond. I collected additional critiques of ADHD treatment by Peter Breggin and Fred Baughman, intending to write an article for my web site. But other interests came along, and I didn’t get around to it for a few years.

As an abstinence-oriented addictions counselor, I have a built-in bias against using stimulant medication to treat behavior problems. According to the U.S. Department of Justice, most ADHD medications have “a high potential for abuse”, leading to possible psychological or physical dependence. In other words, Adderall and Ritalin have the same abuse potential as morphine or OxyContin. It didn’t make sense to me that this “treatment” for ADHD would reverse a biochemical or neurological deficit as claimed. The calming effect of stimulants had to have another explanation.

In the summer of 2012 I finally sat down and did the reading and research to first write: “ADHD: An Imbalance of Fire Over Water or A Case of the Fidgets?” Although I read several studies supporting the use of ADHD medications, I still concluded that the negatives far outweighed the positives.

I don’t think I simply found what I already “knew” to be true because of my built-in bias against stimulant medications. The research convincingly showed that stimulant medications do not really “treat” ADHD. And I think you will too after watching the presentation by Robert Whitaker in: “Medicating ADHD: Diagnosis and the Long-Term Effects of the Medications.”

Here is just one teaser mentioned in the video. William Pelham, a researcher with the Multimodal Treatment of Attention Deficit Hyperactivity Disorder Study (MTA Study), a long term study of the treatment of ADHD funded by the NIMH said: “We thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There were no beneficial effects; none. In the short term [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Viewing ADHD as a simply a neurological disorder that is treated with medication seems to make the mistake of viewing human beings as simply “bodies run amuck” (to use Dave Powlison’s phrase). This reductionistic understanding of human nature neglects a biblical understanding that we are a “psycho-somatic unity” of soul (psyche) and body (soma).

There is nothing morally wrong in using ADHD medications. But given the problems with them, I certainly think it is unwise to use them long-term—particularly since they have the same risk of drug dependency as morphine and OxyContin.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: Peter Breggin