09/26/17

Demolishing ADHD Diagnosis

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The Harvard psychologist, Jerome Kagan, sees ADHD as more of an invented condition than a serious illness. Further, he thinks it was invented for “money-making reasons” by the pharmaceutical industry and pro-ADHD researchers. He believes the drastic increase in the number of children diagnosed with ADHD has more to do with “fuzzy diagnostic practices” and relabeling. Fifty years ago, a 7-year-old child who was bored and disruptive in class was seen as “lazy.” Today he is seen as suffering from ADHD.

Every child who’s not doing well in school is sent to see a pediatrician, and the pediatrician says: “It’s ADHD; here’s Ritalin.” In fact, 90 percent of these 5.4 million kids don’t have an abnormal dopamine metabolism. The problem is, if a drug is available to doctors, they’ll make the corresponding diagnosis.

In his interview with Spiegel Online, Kagan went on to say that the inflated diagnosis of ADHD and other so-called childhood mental health disorders means more money for the pharmaceutical industry, psychiatrists and the people doing research. “We’re up against an enormously powerful alliance: pharmaceutical companies that are making billions, and a profession that is self-interested.” As he said, he’s not the only psychologist who is saying this.

Parenting expert and family psychologist, John Rosemond, agrees with Kagan. In 2009 he co-authored The Diseasing of American’s Children where they argued that ADHD and other childhood behavior disorders “were inventions of the psychological-psychiatric-pharmaceutical industry.” They went further than Kagan in saying that ADHD does not exist; that it is a fiction. In his April 9, 2017 article, “ADHD Simply Does Not Exist,” Rosemond referred to Kagan’s declaration on ADHD, noting that he and other psychologists studied Kagan’s books and research papers on children and child development when they were in graduate school. In The Diseasing America’s Children, Rosemond said:

Science depends on verifiable, objective evidence and experimental results that can be replicated by other scientists. Where ADHD is concerned, neither verifiable, objective evidence nor replicable experimental results exist to support the claims of the ADHD establishment.”

Rosemond and his co-author, Bose Ravenel, believe that childhood behavior disorders like ADHD are manifestations of “dysfunctions of discipline and lifestyle” endemic to modern family culture. Once these problems are identified, they can be easily corrected. And once corrected, the errant behavior “usually recovers to a state of normalcy within a relatively short period of time.” They believe children do not need a psychologist when they misbehave, they need discipline—“firm, calm and loving discipline.”

In Debunking ADHD, educational psychologist Michael Corrigan said ADHD is a negative label that does not exist. “Not unlike the many wonderful stories about unicorns, fairies, and leprechauns, the diagnosis of ADHD is a brilliant work of fiction.” He noted that many of the common childhood behaviors (or supposed symptoms) associated with ADHD are also used to identify giftedness in children. When these behaviors are harnessed and focused, they can help children become “incredibly creative, insightful, and successful individuals in adulthood.” If children don’t learn to harness the power of the behaviors ADHD and giftedness have in common, “such behaviors when displayed might seem annoying and immature.” He said:

My biggest reason for writing this book is my desire to show you that the practice of medicating children for acting like children in the name of ADHD is, in two words, wrong and dangerous. Despite the grandiose claims of the mega-pharmaceutical companies selling ADHD drugs to concerned parents, prescribing pills to young children trying to learn how to become young adults is just a quick fix void of any long-term benefits.

Corrigan described eating lunch with a group of children who had just taken their ADHD medication at school. They were now supposedly “good to go” (sufficiently medicated) for an afternoon of learning. It was the longest lunch period he had ever experienced. “Comparing the kids at my table to others in the cafeteria, and slowly watching these playful, creative, energetic, and funny children go from kids being kids to near expressionless robot-like entities, made me sick to my stomach.”

The total number of children on ADHD medication “skyrocketed” from 1.5 million in 1995 to 3.5 million in 2011. “Sales of prescription stimulants quintupled from 2005 to 2015.” The rising rate of ADHD diagnosis has been described as “an unreal epidemic” and a “national disaster of dangerous proportions” by well-known professionals like Allen Frances and Keith Conners. Frances was the chair of the DSM-IV. Conners, now an emeritus professor of medical psychology at Duke University, “spent much of his career in legitimizing the diagnosis of ADHD.”

Allen Frances was one of four authors of an article in the International Journal of Qualitative Studies on Health and Well-Being, “ADHD: A Critical Update for Educational Professionals.” When the DSM-IV was published in 1994, the prevalence of ADHD was estimated to be 3%. Since then, parent-reported ADHD diagnosis increased to 7.8% in 2003; 9.5% in 2007; and to 11% in 2011. Nearly one in five high school boys had been diagnosed with ADHD and around 13.3% of 11-year-old boys were medicated for ADHD.

Teachers and other school personnel are often the first to suggest a child might be “ADHD.” Research suggested teachers felt insecure about dealing with behavioral problems and hesitated to accept responsibility for students with special needs. Frances and his coauthors described six scientifically grounded issues that educational professionals should be aware of when they are confronted with inattention and hyperactivity in the classroom.

First: birth order matters. Several studies have shown “That relative age is a significant determinant of ADHD diagnosis and treatment.” The youngest children in the classroom are twice as likely to be diagnosed with ADHD and receive medication. They suggest teachers take the child’s relative age into account when judging the child’s behavior. “Seeing ADHD as the cause of inattention and hyperactivity is in fact a logical fallacy as it is circular.”

Second, there is no single cause of ADHD. “There are no measurable biological markers or objective tests to establish the presence or absence of ADHD (or any other given DSM syndrome).” ADHD is a description of behavior and is based on “criteria that are sensitive to subjectivity and cognitive biases.” Multiple factors have been associated with ADHD, without necessarily implying causality. Those factors include: divorce, poverty, parenting styles, lone parenthood, sexual abuse, lack of sleep, artificial food additives, mobile phone use and growing up in areas with low solar intensity. “All these factors and more may play a role when a particular child exhibits impairing hyperactive and inattentive behaviours, and there is no conclusive cause of ADHD.”

Third, most children exhibiting “ADHD behavior” have normal-looking brains. Studies that do show small differences in terms of brain anatomy do not apply to all children diagnosed with ADHD. Individual differences refer to slower anatomical development. “They do not reveal any innate defect as is illustrated by the fact that many people with an unusual anatomy or physiology do not experience ADHD related problems.” Also, the test subjects in many brain-related studies are rigorously screened and don’t represent all individuals diagnosed with ADHD.

The samples do not comprise an accurate representation of their respective populations, meaning an average child with a diagnosis of ADHD and an average “normal” child. This problem is particularly urgent since the DSM 5 has lowered the age of onset criterion, as well as the impairment criterion compared to the previous version, the DSM-IV. Alongside the lowered threshold, the potential to generalize earlier research findings has lowered as well.

Fourth, the claims of ADHD being inherited may be overestimated.  The claims vary widely and are subject to debate because of methodological issues used in calculating the heritability coefficient in twin, familial and adoption studies. There is significant difficulty separating genetic influences from environmental ones, such as poverty, parenting styles and divorce, in these studies. “In genetic association studies that really analyse genetic material and that are more powerful when separating the influence of genetics from other etiologic sources, associated genes show only very small effects.” When combined, they explain less than 10% of variance.

This means they occur only slightly more often in diagnosed individuals than in controls, and they do not explain nor predict ADHD behaviours. For educational professionals, this is important to consider as an ADHD label might give a false sense of security with regard to the alleged (genetic) cause of a child’s behaviour and the preferred cure (medication).

Fifth, medication does not benefit most children in the long run. Follow up studies of the long-term effects of the MTA (Multimodal Treatment of Attention Deficit Hyperactivity Disorder) study showed a convergence of outcomes over time between medicated and non-medicated children. Other studies also report either no long-term benefits, or even worse benefits. “While medication may help a small group of children in the long run, most will not benefit from long-term pharmaceutical treatment.”

The sixth and final issue that educational professionals should be aware of when confronted with inattention and hyperactivity in the classroom is the reality that a diagnosis can be harmful to children. A CDC MMWR Report indicated only 13.8% had severe ADHD, with 86.2% having mild (46.7% or moderate (39.5%) ADHD. The authors pointed out a DSM diagnosis opened the door for additional reimbursement to the school for treatment and school services, perhaps promoting a search for pathology in relatively mild cases. “The question is whether in these mild cases the merits of a confirmed diagnosis—such as acknowledgement of problems and access to help—outweigh possible demerits.” Some known disadvantages of a diagnosis are: lower teacher and parent expectations that turn into self-fulfilling prophecies, prejudice and stigmatization of diagnosed children, a more passive role towards problems, difficulties getting life and disability insurances later on in life, and others.

The Allen Frances article linked above was the most accepting of ADHD as a legitimate “neuro-developmental disorder.” Yet it cautioned there was no single cause for ADHD, medications to “treat” ADHD did not have long-term benefits, and there was a problem with its over diagnosis. Jerome Kagan thought 90% children were wrongly diagnosed with ADHD because of “fuzzy diagnostic practices and relabeling.” Michael Corrigan, John Rosemond and questioned the validity of ADHD as a neuro-developmental disorder. Corrigan said it pathologized normal childhood behavior; and medicating these children was wrong and evil. It’s time to demolish the ADHD treatment empire.

Additional articles on ADHD can be found on this website here: “National ADHD Epidemic,” “Misleading Info on ADHD,” “Tip of the ADHD Iceberg,” and “Is ADHD Simply a Case of the Fidgets?” You can also read a longer paper: “ADHD: An Imbalance of Fire Over Water of a Case of the Fidgets?

08/1/17

Repeating Past Mistakes

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At 4:45 a.m. on September 1, 1939, 1.5 million German troops invaded Poland. Two days later Britain and France declared war on Germany and World War II had begun. This “blitzkrieg” strategy became a blueprint of how Hitler intended to wage war. Generally unknown, one of the key tools in the success of the German Wehrmacht was their use of a methamphetamine called Pervitin. The troops were literally on cloud nine about Pervitin, as were their commanders.

Reports from the front lines on the drug included the following glowing testimonies:

Everyone fresh and cheerful, excellent discipline. Slight euphoria and increased thirst for action. Mental encouragement, very stimulated. No accidents. Long-lasting effect.The feeling of hunger subsides. One particularly beneficial aspect is the appearance of a vigorous urge to work. The effect is so clear that it cannot be based on imagination.

Not surprisingly, addiction became a problem. In April and May of 1940 alone, the Nazis shipped 35 million units of Pervitin and similar medications to its troops. Troops at the front sent letters home begging for more Pervitin. “Everybody, from generals and their staffs to infantry captains and their troops, became dependent on methamphetamine.” A lieutenant colonel leading a Panzer division wrote the following in a report:

Pervitin was delivered officially before the start of the operation and distributed to the officers all the way down to the company commander for their own use and to be passed on to the troops below them with the clear instruction that it was to be used to keep them awake in the imminent operation. There was a clear order that the Panzer troop had to use Pervitin.

“Speed” or amphetamine is in ADHD medications like Adderall (amphetamine/dextroamphetamine), Vyvanse (lisdexamfetamine). Methylphenidate (Concerta, Ritalin, Daytrana) is their close chemical relative. By the way, don’t be fooled by the creative spelling done by Shire for Vyvanse: “lisdexamfetamine” instead of “lisdexamphetamine.” Writing for The Guardian, Alexander Zaitchik noted  how the phonetic sleight-of-hand of Shire with Vyvanse and its aggressive marketing contributed to its success in getting the FDA to approve Vyvanse to treat “Binge Eating disorder.”

The company’s neo-phoneticism is intended to put more distance between its new golden goose and the deep clinical literature on speed addiction, not to mention last century’s disastrous social experiment with widespread daily speed use, encouraged by doctors, to temper appetites and control anxiety.

What follows is a history of amphetamines gleaned primarily from two sources: a paper on Amphetamines from the Center for Substance Abuse Research (CESAR) of the University of Maryland and a 2008 article by Nicolas Rasmussen for the American Journal of Public Health, “America’s First Amphetamine Epidemic 1929-1971.”

Amphetamine was first synthesized by a German chemist in 1887, but its stimulant effects weren’t noticed until the early 1930s, when it was rediscovered by accident. The chemist was trying to make ephedrine, a decongestant and appetite suppressant. Branded as Benzedrine, amphetamine was marketed as an inhaler for nasal congestion by the pharmaceutical company, Smith, Kline & French starting in 1933. It didn’t take some people long to figure out how to use Benzedrine for its euphoric effect. They cracked the container open and swallowed the Benzedrine-coated paper strip or steeped it in coffee.

Its use grew rapidly as medical professionals recommended amphetamine for alcohol hangover, depression, narcolepsy, weight-loss, hyperactivity in children and morning sickness in pregnant women. “The use of amphetamine grew rapidly because it was inexpensive, readily available, had long lasting effects, and because medical professionals purported that amphetamine did not pose an addiction risk.” During World War II, amphetamines or methamphetamine (a derivative of amphetamine) were used by both Allied and Axis troops to increase their alertness and endurance, as well as to improve their mood.

By 1945, over 500,000 civilians were using amphetamine psychiatrically or for weight loss. Between 1945 and 1960 commercial competition drove amphetamine use higher. After a patent expired in 1949, the FDA estimated the production of amphetamine and methamphetamine rose almost 400% by 1952. By 1962, production of amphetamines was approaching 43 standard 10-mg doses per person. This compares to concerns with the 65 doses per year in the present decade that social critics of our cultures point to as evidence of the overuse of psychotropic medications.

The adverse effects of amphetamine were becoming more evident by 1960. Amphetamine psychosis had been known since the 1930s, but was initially attributed to the drug unmasking latent schizophrenia. This claim is eerily similar to current interpretations of antidepressant activation unmasking latent bipolar disorder, rather than being seen as an adverse side effect of antidepressant medication. There were also concerns that amphetamines were addictive. But this didn’t stop individuals like President John F. Kennedy from using regular injections of vitamins, hormones and 15 mg of methamphetamine to help maintain his image of youthful vigor.

Large quantities of amphetamines were dispensed in the 1960s directly by diet doctors and weight loss clinics. Calculations of amphetamine use and misuse in 1970 estimated that at least 9.7 million Americans had used the drugs in the past year. And of those 9.7 million users, 3.8 million do so for nonmedical reasons and 2.1 million of those abused the drugs. Rasmussen said this first amphetamine epidemic was iatrogenic, “created by the pharmaceutical industry and (mostly) well-meaning prescribers.”  The current problem with the misuse of amphetamines has reached the peak of the original epidemic, namely about 3.8 million past-year nonmedical amphetamine users, with an estimated 320,000 of whom are addicted.

Parallel to this trend has been the surge in the legal supply of amphetamine-type ADHD medications such as Ritalin, Adderall and Vyvanse. American doctors, unlike those in other countries, have found it hard to resist prescribing these drugs. According to DEA production data, since 1995 medical consumption of these drugs has quintupled. In 2005, it exceeded the amphetamine consumption of 2.5 billion 10-mg amphetamine base units for medical use in 1969—compared to 2.6 billion base units in 2005. The following graph, taken from Rasmussen’s article, illustrates this increase. The data is based upon DEA production quotas and expressed as common dosage units of 10-mg amphetamine and 30-mg methylphenidate.

Rasmussen downplayed a causal connection between childhood stimulant treatment for ADHD and later nonmedical amphetamine consumption, but others don’t (See more on this below). However, he did think the wide distribution of ADHD stimulants, noted in the above graph, created a hazard. He cited data from a study that indicated 600,000 reported using stimulants other than methamphetamine nonmedically in the past month. So, “legally manufactured attention deficit medications like Adderall and Ritalin appear to be supplying frequent, and not just casual, misusers.”

An analysis of stimulant abuse in recent national household drug surveys found that half of the 3.2 million reporting past-year nonmedical use of stimulants in the U.S. only used psychiatric stimulants. And 750,000 of those reported they had never used anything but attention deficit pharmaceuticals in their entire lives. “On this evidence alone, one can fairly describe the high production and prescription rates of these medications as a public health menace of great significance.”

Another problem is the widespread acceptance of prescription amphetamines as a legal and relatively harmless drug that can be given to small children. Rasmussen said it is difficult to make a convincing case that the same drug is harmful if used nonmedically. Therefore he concluded any attempt to deal harshly with methamphetamine users today in the name epidemic control, without touching medical stimulant production and prescription was practically impossible and hypocritical.

There is some evidence of a connection between childhood stimulant treatment and later abuse or use of stimulants. See “ADHD: An Imbalance of Fire Over Water or a Case of the Fidgets?” on this website for a discussion of the association of addiction and ADHD medications as well as other adverse effects.

Nadine Lambert did a longitudinal study of ADHD children and normal controls. Her participants were followed through their childhood and adolescence and then evaluated three times as young adults. “ADHD was also significantly associated with amphetamine dependence.” However, being diagnosed with ADHD did not increase the odds of lifetime use of stimulants. She found that treatment with stimulants increased the odds of lifetime use of amphetamine and cocaine/amphetamines.

Commenting on Lambert’s findings in Brain Disabling Treatments in Psychiatry, Peter Breggin said:

It is not ADHD but the treatment for ADHD that puts children at risk for future drug abuse. This conclusion is entirely consistent with the fact that animals and humans cross addict to Ritalin, amphetamine and cocaine and that exposure to Ritalin in young animals causes permanent changes in the brain.

Hitler and his generals wanted victory at any cost and Pervitin (methamaphetamine), was part of that solution. German pilots called it “pilot’s chocolate”; soldiers on the front called it “Panzerschokolade” or “tank chocolate.” But towards the end of WW II, Vice Admiral Hellmuth asked German pharmacologists to develop a miracle drug. They had a wonder drug with Pervitin, but now they needed a miracle drug. So Gehard Orxzechowski synthesized D-IX. It was supposed to keep soldiers ready for battle even when they were asked, “to continue beyond what was considered normal.” It contained 5 mm of cocaine, 3mm of Pervintin and 5mm of morphine. It seems it was a good thing the war ended before they could distribute it widely to their troops.

We have a lesson to learn from the German Wehrmacht’s failure to make a better, smarter, stronger soldier through chemicals. The American war on drugs needs to recognize its greatest casualties are now coming from within—as with ADHD medications. And I think we need to reflect on the words of George Santayana in The Life of Reason: “Those who cannot remember the past are condemned to repeat it.”

06/30/17

Rooting for the Underdog

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In July of 2010, a 57-year-old partner at the law firm Reed Smith jumped in front of a subway train in Chicago and died. His widow, Wendy Dolin, sued the pharmaceutical companies GlaxoSmithKline (who originally manufactured Paxil) and Mylan (the drug company who manufactured paroxetine, the generic version that Stewart Dolin took), charging that the drug caused akathisia, which led to his suicide. GSK attorneys dismissed the testimony of the plaintiff’s expert witness as “junk science,” which argued for a link between the drug and suicide. However it seems the jury disagreed, since on April 20th, 2017 they awarded a $3 million verdict for the plaintiff.

Mylan was released from the suit by the trial judge, who ruled they had no control over the drug’s label. GSK continues to maintain the company wasn’t responsible since it hadn’t manufactured the drug taken by Dolin. A Chicago Tribune article quoted Wendy Dolin as saying the ruling was “a great day for consumers.” The trial was not just about the money for her. It was about awareness to a health issue. But this isn’t the end. “Officials from the pharmaceutical company said the verdict was disappointing and that they plan to appeal.” GSK continues to assert they weren’t responsible because they didn’t manufacture the drug taken by Dolin.

Writing for Mad in America, attorney and activist Jim Gottstein noted the legal significance of the case, as it established GSK did not inform the FDA or doctors that Paxil could cause people to commit suicide—a conclusion GSK continues to deny. A second legal hurdle overcome by the ruling is a Catch-22 dilemma since SSRIs, like Paxil, are now usually prescribed as generics. “The generic drug manufacturer [Mylan} isn’t liable because it was prohibited from giving any additional information and the original manufacturer [GSK] isn’t liable because it didn’t sell the drug.” You can read Jim Gottstein’s article for an explanation of how these legal hurdles were overcome.

Bob Fiddaman interviewed Wendy Dolin after the verdict and she described some disturbing tactics used by GSK attorneys. She said depositions that should have been a few hours long became eight hours, “in an attempt to wear people down.” She said GSK asked the same question over and over again, hoping to confuse or manipulate people. She alleged they also called her friends, trying to get them to say something negative about her relationship with her deceased husband.

As a therapist, as a mother and a compassionate human being, I am aware there was no purpose to have done such. I have talked to therapists, physicians and pharmaceutical lawyers and all agree there was nothing gained by this other than to show me that GSK would stop at nothing to intimidate me.

During the trial it came to light that 22 individuals had died in Paxil clinical trials, 20 by suicide; two other deaths were suspected to be suicide. “All 22 victims were taking Paxil at the time, and 80% of these patients were over the age of 30.” GSK tried to argue their “illness” caused their deaths and not Paxil. Wendy Dolin said the lawsuit showed that “akathisia is a real, legitimate adverse drug reaction.” The public needs to be aware of its signs and symptoms.

Wendy said she knew even before they went to trial, that GSK would appeal the ruling if they lost. She thought there was a GSK lawyer in the courtroom during the trial gathering information for the appeal process. She said it had been suggested this case could go all the way to the Supreme Court, because GSK is afraid of the legal ramifications of a guilty verdict. The process could take 5-7 years. She said: “Clearly this case has never been about money. For me, it has always been about awareness, highlighting akathisia and ultimately changing the black box warning to include all ages.”

Writing for STAT News, Ed Silverman suggested the new head of the FDA, Scott Gottlieb, should require a stronger warning label for Paxil. “For the past decade, Paxil’s label has not carried any information indicating the drug poses a statistically significant risk of suicidal behavior for anyone over 25.” Yet there is scientific evidence of such a risk. See Table 16 in the linked “Exhibit 40” document of his article (I assume it’s from the Dolin trial). Silverman said: “For public health reasons, the FDA should pursue a warning.”  A former FDA commissioner was quoted as saying it was hard for him to understand why the warning of increased suicidal risk was not in the label.

But sucidality is not just a risk with Paxil (paroxetine). A meta-analysis done by Peter Gotzsche of the Cochrane Collaboration concluded that antidepressants doubled the risk of suicidality and aggression in children and adolescents. Gotzsche and his team of researchers reviewed the clinical study reports for duloxetine (Cymbalta), fluoxetine (Prozac and Sarafem), paroxetine (Paxil), sertraline (Zoloft), and venlafaxine (Effexor). Estimates of harm could not be accurately done because the quality of the clinical study reports varied drastically, limiting their ability to detect the harms. The true risk for serious harms was uncertain, they said, as the low incidence of these events and the poor design and reporting of the trials made it difficult to get accurate estimates.

A main limitation of our review was that the quality of the clinical study reports differed vastly and ranged from summary reports to full reports with appendices, which limited our ability to detect the harms. Our study also showed that the standard risk of bias assessment tool was insufficient when harms from antidepressants were being assessed in clinical study reports. Most of the trials excluded patients with suicidal risk and so our numbers of suicidality might be underestimates compared with what we would expect in clinical practice.

In April of 2016, the CDC released data indicating the suicide rate in the U.S. increased by 24% from 1999 to 2014. Overall, the age-adjusted suicide rate increased from 10.5 per 100,000 in 1999, to 13.0 per 100,000 in 2014. The rates increased for both males and females and for all ages from 10 to 74. The age-adjusted rates for males (20.7 per 100,000 population), was over three times that of females (5.8 per 100,000). Males preferred firearms as a method (55.4%), while poisoning was the most frequent method for females (34.1%). However, this was a lower percentage for both sexes than in 1999. See the following figure from the CDC Report noting suicide deaths by method and sex for 1999 and 2014.

This reverses a trend from 1985 to 2000, where the U.S. suicide rate was dropping. See the following chart taken from an NPR report on the same data.  The president-elect of the American Psychiatric Association (APA), Maria Oquendo, said she thought the late 1980s drop was probably due to the fact that new antidepressants (SSRIs) were more effective and had fewer side effects.

Karter noted how Oquendo and Christine Moutier (from the American Foundation for Suicide Prevention) both saw the addition of black box warnings of the potential for suicide in teenagers and young adults as contributing the rise in suicide rates. Moutier was more direct, stating the progress in depression treatment in the 80s and the 90s “was undone in recent years because of concerns that antidepressants could increase suicide risk.” Oquendo thought the increase of suicide deaths in younger populations was potentially due to the understandable reluctance of physicians to prescribe antidepressants to these individuals, “even when they’re aware the individual is suffering from depression.” She added how research showed the benefits outweigh the risks of prescribing antidepressants to children and adolescents.

But Justin Karter indicated this suggestion, that the warning labels led to a decreased number of antidepressant prescriptions for teenagers and adults, was inaccurate. Although several media outlets reported the increase in the suicide rate, they didn’t report the corresponding increase of Americans taking antidepressants, a rate that has nearly doubled.

There was a report published in the British Medical Journal in June of 2014 that indicated black box warnings on SSRIs had a paradoxical effect, with an increase in suicide attempts among youths. Mad in America cited 12 critics of the study and noted its multiple flaws. The unwarranted conclusion, namely lead to increasing the prescription of antidepressants to teenagers and youths, had the potential to do considerable harm. Mad in America concluded that it should never have been published. Among the problems with the study were the following:

The researchers’ stated conclusion, which was that a decrease in antidepressant prescribing in youth following the black box warning led to an increase in suicide attempts, isn’t supported by their own data. (1) There was not a significant decrease in SSRI prescriptions to teenagers and young adults following the black box warning. (2) Psychotropic drug poisonings are not a good proxy for suicide attempts. (3) This coding category actually tells of poisonings due to the use of psychiatric drugs, as opposed to their non-use. (4) Finally, there was no significant increase in the number of poisonings.

Additionally, Kantor et al., in “Trends in Prescription Drug Use Among Adults in the US” reported data from the National Health and Nutrition Examination Survey (NHANES) indicated that the use of antidepressants increased from 6.8% to 13% between 1999 and 2012. Yet, as Justin Karter reported, “The American Psychiatric Association guidelines continue to suggest medications as the preferred treatment for moderate to severe depression.”

If you’re still not convinced, take some time to read through a series of scientific articles submitted by Peter Breggin in his affidavit for another Paxil-related suicide trial. The topics covered included exhibits of Paxil causing suicidal behavior as well as SSRIs and SSRI withdrawal causing suicidality. There is another section on Dr. Breggin’s website that is an “Antidepressant Drug Resource & Information Center” with even more relevant articles.

Given the above discussion on antidepressants, the recent court ruling in Illinois awarding $3 million to Wendy Dolin has the potential to lead to an unknown number of future lawsuits, if it is upheld upon appeal. This could end up costing the pharmaceutical companies that brought now off patent SSRIs and SNRIs to market untold millions and possibly billions of dollars in further awards. So you can bet that GlaxoSmithKline has plenty of pharma companies (and their legal representatives) rooting for GSK to overturn the ruling in the Dolin case. Me, I’m rooting for the underdog here—the 13% of Americans who are taking antidepressant medications without clearly knowing the potential they have to make their depression and its consequences worse.

01/13/17

Iatrogenic Gun Violence

© StephanieFrey | stockfresh.comfresh eggs. Araucanas are also known as the Easter Chicken for the blue or greenish colored eggs they lay.

Whenever I read about horrific violence like the incident in the Fort Lauderdale airport, I wonder what role psychiatric medications played. I wonder if the violent behavior was iatrogenic—was it caused by psychiatric medications? This question will sound counter intuitive for many people. Surely the reverse is true. Psychiatric medication and proper diagnosis should have prevented it. Let’s see if it is.

Esteban Santiago was deployed to Iraq from April 2010 to February 2011 with the 130th Engineer Battalion, the 1013th Engineer Company of the Puerto Rico National Guard. After flying from Alaska to Fort Lauderdale Florida, he retrieved his baggage, which incidentally contained a semi-automatic handgun. Santiago had followed proper protocol, checking the weapon with TSA. He went into the men’s bathroom, loaded his weapon and opened fire in Terminal 2 of the airport, killing five people and wounding six others. A witness said he was just randomly shooting people, with no rhyme or reason to it.

Family members reported that he was a changed man when he returned from Iraq. His aunt said his mind was not right. At times he seemed normal, but other times he seemed lost. In Iraq, his unit cleared roads of improvised explosive devices and maintained bridges. Two people in his unit died while he was in Iraq. His aunt said: “He talked about all the destruction and the killing of children. He had visions all the time.” He had changed.

His brother Bryan confirmed that recently Esteban was hallucinating, but said he was receiving psychological treatment. Bryan said he believes the shooting rampage resulted from mental issues that surfaced after the Iraq tour. When Esteban’s tour ended, he was hospitalized for mental problems. Upon his release, he went to Puerto Rico where his father was ill and eventually died. While in Puerto Rico, he received mental health therapy. Esteban eventually moved to Alaska, where he joined the Alaska National Guard in November 2014. He was discharged in August of 2016.

Over the course of 2016, Santiago was repeatedly reported to Anchorage police for physical disturbances. In January of 2016 he was arrested and charged with assault and criminal mischief after an argument with his girlfriend. He allegedly yelled at her while she was in the bathroom and broke down the bathroom door. She told investigators that he tried to strangle her and struck her on the side of the head.

Santiago pleaded no contest to criminal mischief and assault charges. Under a deferred prosecution agreement, his charges would have been dismissed if he complied with the conditions. He was due back in court on March 28th, 2017 to assess his progress.

While living in Alaska, Esteban continued to receive psychological treatment, according to his brother. Although his girlfriend alerted the family to the situation in Alaska, Bryan said he did not know what mental health problem Esteban was being treated for; they never spoke about it by phone.

His son was born in September of 2016. In November of 2016, Esteban walked into an FBI office in Anchorage to report that his mind was being controlled by a U.S. intelligence agency. He told officials he had a firearm in his car, along with his newborn son. Santiago was checked into a mental health facility; his firearm was logged as evidence for safe keeping. The infant’s mother came for their child. FBI special agent Marlin Ritzman said:

During the interview, Mr. Santiago appeared agitated, incoherent and made disjointed statements. Although he stated he did not wish to harm anyone, as a result of his erratic behavior our agents contacted local authorities, who took custody of Mr. Santiago and transported him to the local medical facility for evaluation.

After conducting database reviews, interagency checks and interviews with his family members, the FBI closed its assessment of Santiago. Agents found no ties to terrorism during their investigation. A CNN senior law enforcement analyst and former FBI assistant director said Santiago hadn’t been adjudicated a felon and he hadn’t been adjudicated as mentally ill. So they couldn’t keep his weapon. The Walther 9-millimeter pistol was returned to him in the beginning of December. Authorities told CNN it was the pistol he used in the shooting incident in Fort Lauderdale.

Typically, Esteban was considered to be a calm young man who was never violent. Recently he began selling his possessions, including his car. Friends and associates noticed more erratic behavior. He bought a one-way ticket to Fort Lauderdale and packed his pistol and two magazines. His carryon bag with the pistol was his only luggage. He flew from Anchorage to Minneapolis to Fort Lauderdale. He retrieved his bag from the baggage claim area and went into a men’s room stall to load his pistol.

He shot the first people he saw, going up and down the carousels of the baggage claim, shooting through luggage to get at people that were hiding. He thinks he fired 15 bullets, aiming at his victim’s heads. A witness said Esteban showed no remorse. He didn’t say anything. “No emotion, no nothing. About as straight-faced as you get.” Afterwards, he just lay face down, spread eagle, waiting for the deputies to come and get him.

The above report was pieced together from information contained in the following reports by The New York Times here,  NJ.com here, CNN here, and NPR here.

There was no explicit mention of Santiago’s repeated involvement in “psychological treatment” involving psychiatric medications, but it highly probable he was taking psychiatric medication of some sort. The lack of any mention of his being prescribed medication may simply be due to confidentiality regulations. Or this silence could be due to the chicken-and-egg argument often applied to incidents involving violence and individuals with known psychiatric problems. Their mental illness, not the drugs to treat it, caused their horrific behavior.

Several psychiatrists have voiced concerns with psychiatry, its over reliance upon medication and denial of serious adverse effects from medication, like violence and suicide. Joanna Moncrieff said she’s sad her profession has not taken the harms drug treatments can do more seriously. She said it has a long history of ignoring the adverse effects of drugs, or attributing them to the underlying disease—of blaming the patient instead of the drug. “Too many psychiatrists have just accepted that drug treatments are good, and have not wanted to contemplate that actually these treatments could be harmful.”

First and foremost, she said, psychiatry needs to adopt a drug-centered model for understanding its drug treatments and what they do to people. Psychiatrists need more information, knowledge and training on what the drugs do—what effects they produce in people; “how they change the way that people think and feel and what sort of impact those changes have on people’s lives.” Watch two brief videos of her expressing her concerns here. You can read more about her “drug-centered model” here on this website: “A Drug is a Drug is a Drug.”

Peter Breggin has raised concerns with the association of violence and antidepressants since the early days of Prozac. In his 1991 book, Toxic Psychiatry, Dr. Breggin related newspaper and scientific reports pointing to an association between Prozac and “compulsive, self-destructive and murderous activities.” He said then he was personally familiar with several cases of compulsive suicidal or violent feelings that developed after taking Prozac. Over the years, his familiarity grew.

In “Psychiatry Has No Answer to Gun Massacres,” Breggin described how the Columbine High School shooter, Eric Harris had a “therapeutic” level of Luvox (fluvoxamine) in his body at the time of the murders.  He had a dose increase in his medication 2 ½ months before the assault and showed signs of drug toxicity five weeks before the event. James Holmes, the Aurora Colorado theater shooter, was in psychiatric treatment with the medical director of student health services, who was considered an expert on campus violence. She was concerned enough about Holmes to report him to the campus police and the campus threat assessment team a few weeks before the assault. When the assessment team suggested putting him on a 72-hour involuntary hold, she rejected the idea. “When Holmes quit school, the school washed its hands of all responsibility for him.”

In a 2010 journal article, “Antidepressant-Induced Suicide, Violence, and Mania: Risks for Military Personnel,” Dr. Breggin related how the adverse effects described in the 2009 edition of the Physicians’ Desk Reference for Zoloft (sertaline) resembled the most frequent psychiatric disorder associated with combat—PTSD—with its hyperalert overstimulated symptoms. He said identical or nearly identical warnings can be found in all antidepressant labels. “All these potentially dangerous symptoms are also commonly seen in PTSD in military personnel, posing the risk of worsening this common military disorder.”

Looking at the revised 2016 medication guide for Zoloft, we see that nothing much has changed with regard to adverse effect warnings. It said Zoloft and other antidepressant medications could increase suicidal thoughts or actions. Symptoms needing immediate attention included: acting aggressively or violent, feeling agitated, restless angry or irritable, an increase in activity or talking more than what is normal, acting on dangerous impulses, trouble sleeping, new or worse anxiety or panic attacks, trouble sleeping, other unusual changes in behavior or mood.

A condition known as “serotonin syndrome” has symptoms such as: agitation, hallucinations, coma and other changes in mental status. Symptoms of potential manic episodes included: greatly increased energy, racing thoughts, unusually grand ideas, severe trouble sleeping’s, reckless behavior, excessive happiness, talking more or faster.

Dr. Breggin concluded his article with the following cautions and recommendations. He said there was a strong possibility the increased suicide rates among active-duty soldiers were in part caused or made worse by the widespread prescription of antidepressant medication. Alone, they can cause a stimulant-like series of adverse effects. “These symptoms of activation can combine adversely with similar PTSD symptoms found so commonly in soldiers during and after combat.” He recommended the military study the relationship between psychiatric drug treatment and suicide as well as random or personal violence. He also suggested that antidepressants should be avoided in the treatment of military personnel.

Another emerging concern of an association between antidepressants and violence is in the research done by Yolande Lucire. She suggested that mutations in CYP450-encoding genes contributed to problems metabolizing psychiatric drugs, and thus were contributing factors in three cases of antidepressant-induced akathisia-induced homicide. The cytochrome P450 family of enzymes is responsible for metabolizing most of the drugs used in psychiatry. You can read her article here. You can also find another article: “Psych Drugs and Violence” on this web site. Within that article you will find a link to another article by Lucire on antidepressant-induced akathisia-related homicide and the CYP450 genes.

Hasn’t there been enough evidence associating suicide and violence with psychiatric medications, especially antidepressants, for open dialogue and more comprehensive scientific research into this public health issue? How many more Columbines, Auroras and Fort Lauderdales need to happen before we begin to address the association of psychiatric drugs and violence?

12/23/16

Listening to Antidepressants

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Prozac took the U.S. by storm when the FDA approved it in 1987.  It also had a similarly radical effect on the thinking of a forty year-old psychiatrist named Peter Kramer. In the Introduction of his now classic book, Listening to Prozac, Kramer described how people became “better than well” with Prozac and how they and he began to “listen” to what Prozac told them. Kramer said it “transformed my views about what makes people the way they are.” But even by 1993, when Listening to Prozac was published, the stories of violence and suicide after taking the first SSRI antidepressant were circulating as well.

Toxic Psychiatry by another psychiatrist named Peter Breggin, was published two years earlier and documented reports of suicidal behavior in both the popular press and the professional literature. “Suicidal Behavior Tied to Drug,” was published on February 7, 1991 in The New York Times. The article said two cases of suicidal behavior and fantasies (with no prior history) were reported in The New England Journal of Medicine that same day. Eli Lilly was facing more than 50 lawsuits at the time and of course denied that there was any scientific merit to the claim the medication could prompt suicidal or violent acts. The year before, “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” was published in the February 1990 issue of The American Journal of Psychiatry. Its abstract read:

Six depressed patients free of recent serious suicidal ideation developed intense, violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment. This state persisted for as little as 3 days to as long as 3 months after discontinuation of fluoxetine. None of these patients had ever experienced a similar state during treatment with any other psychotropic drug.

Breggin also seems to have predicted the rise of what is now called “treatment resistant depression” with SSRIs. He said: “If Prozac can indeed alleviate depression by making more serotonin available in the brain, then with time it may produce incurable depression by making the brain relatively unresponsive to any amount of serotonin.” In Talking Back to Prozac in 1995, Breggin “blew the whistle” on the newer antidepressants and antidepressant-induced violence, suicide and mania. Finally in 2004 the FDA finally required black box warnings to be placed on the newer antidepressants, warning of the potential for the increased risk of suicidal thoughts and behavior in children and adolescents.

Yes, Dr. Kramer did say as far back as Listening to Prozac that the chemical imbalance theory (the amine hypothesis) was at least incomplete and perhaps false. But then Kramer published Against Depression in 2005, arguing that the socio-economic costs of depression were so large, that modern societies should strive to eradicate it as they did with smallpox. On his blog in 2008 he argued that the chemical imbalance theory was prematurely declared dead, even though “the neurotransmitter theory is incomplete and not fully proven.”  He asserted that since 1993 the evidence for it had been steadily growing.

Jonathan Leo and Jeffrey Lacasse did an in depth critique of the evidence Dr. Kramer used to support the chemical imbalance theory. They noted several qualifications used when scientists discuss the biological basis of mood with other scientists. “Yet, in the popular press all these qualifications disappear and instead the public is inundated with declarations about ‘chemical imbalances causing mental illness.’” They said there were two different discussions going on about the theory—a simple, straightforward one in the media and advertisements, but a tenuous nuanced one in scientific circles. In scientific circles, the discussion was about the appropriateness of using the chemical imbalance theory with patients and not so much about the strength of the theory.

In the late 1990s, Irving Kirsch decided to research the placebo effect with the newer (SSRIs and SNRIs) antidepressants. He began with the assumption that there actually was a therapeutic effect with antidepressants, but he wanted to assess the placebo effect: “I was not particularly interested in the drug effect. I assumed that antidepressants were effective.” He was surprised to discover how small the drug effect was. Seventy-five percent of the improvement in the drug group also occurred with people who were given placebo pills with no active ingredient in them.

Critics of his findings said the meta-analysis he and his co-author had done was biased; that they had an unrepresentative sample of clinical trials. So Kirsch and three others replicated the original study with the identical data set used by the pharmaceutical companies for the FDA approval of six of the new generation antidepressants at the time. These six accounted for the bulk of antidepressant prescriptions being written at the time, 2002. “In the data sent to us by the FDA, only 43% of the trials showed a statistically significant benefit of drug over placebo. The remaining 57% were failed or negative trials.” The results here were that 82% of the response to antidepressants was due to the placebo effect.

Kirsch again did a replication in 2008 with a larger number of clinical trials and again found the 82% placebo effect. In both analyses, the mean difference between drug and placebo was less than two points (1.8) on the HAM-D depression scale, used in all the FDA clinical trials for antidepressants at the time. The difference was clinically insignificant. In other words, these miniscule differences were too small to be observable in a normal clinical setting with someone who was depressed. Others, including the FDA, have repeatedly replicated their results. The above history can be found in a 2014 article by Irving Kirsch, “Antidepressants and the Placebo Effect,” or in his 2010 book, The Emperor’s New Drugs. There he speculated:

Antidepressants may be nothing more than active placebos, producing side effects through chemical means and therapeutic effects through psychological means.

Twenty-three years after Listening to Prozac, Peter Kramer published his latest book, Ordinarily Well: The Case for Antidepressants. According to Jonathan Rosen, who wrote “The Assault on Antidepressants” for The Atlantic, Kramer said he believed in the utility of antidepressants, despite their flaws. He not only sought to make a case for antidepressants, he also tried to make a case for psychiatry as “a humanistic science that bridges the impersonal ideals of the laboratory and the pragmatic exigencies of clinical intervention.”

In a book review of Ordinarily Well for The New York Times, Jennifer Senior referred to the original Kirsch research and said Kramer was wary of these studies because they flew in the face of his clinical experience. Indicating that when his own patients asked if their improved mood could be due to a placebo effect, “Dr. Kramer’s answer is an unequivocal no.” And Ordinarily Well attempted to prove his belief. Senior indicated Kramer argued that Kirsch deliberately “’seemed to cull studies in which antidepressants underperformed,’ and treated some drugs as placebos even though they may have had antidepressant effects.” Either Senior or Kramer was unaware of, or failed to mention the above-described replications done by Kirsch and others. She did point out how Kramer used meta-analyses to make his own points, but failed to acknowledge that fact. Another area of concern for Kramer was the mechanism for recruiting subjects for clinical trials.

He is particularly devastating on the subject of recruiting test subjects. One of the most damning chapters features an unnamed facility where antidepressant trials are frequently conducted. Many of the participants are unemployed or underemployed — lonely, dispossessed and eager for the money. Suddenly, they’re getting paid, interacting with others and receiving the careful attention of doctors and nurses. “Even on placebo,” Dr. Kramer writes, “these patients ought to get better.”

There is an indication that evidence-based medicine has some flaws; and that the gold standard of meta-analysis can be undermined by flawed analysis, especially in psychiatric drug research. And there really is a problem with recruiting clinical trials subjects; and sometimes with the methodologies used by researchers in those clinical trials. But remember that if Kramer’s concerns are accepted (and I think they should be), then the newer antidepressants were approved using questionable scientific methods and an unreliable approval process. See “Evidence-Based Treatment … Lacks Evidence.”

If that is the case, where is the protection that FDA approval of pharmaceuticals is supposed to provide? And why aren’t more people pressing for regulatory reform of the FDA clinical trial process? If we accept Kramer’s arguments, we should also acknowledge that the clinical trials used for FDA approval of SSRIs were invalid. Kramer’s rationale for dismissing the evidence for the placebo effect with antidepressants also calls into question the methods used for their approval—and many of the studies afterwards touting their continued effectiveness.

A recent review article by Andrews et al., “Is Serotonin a Downer or an Upper?” challenged the assumptions of the therapeutic effects of SSRIs. “Although the idea that a single neurochemical is the cause of depression is now considered simplistic, the low serotonin hypothesis still lies at the foundation of most research on depression.” The authors noted how many types of depression seem to correspond to higher levels of serotonin, not lower ones. They proposed a radical new way of understanding the role of serotonin in the brain, according to Shannon Peters in, “How Do Antidepressant Really ‘Work’?” They suggest that serotonin coordinates metabolic processes with the storage, mobilization, distribution, production and utilization of energy resources.

Under this theory, there are higher levels of serotonin when there is a need to redistribute limited energy resources. “Serotonin cannot be simply described as an ‘upper’ or a ‘downer’; its symptomatic effects depend on the organism’s state,” write the authors.

When listening to antidepressants, we hear a history of effectiveness that can’t be clearly attributed to the therapeutic effect of the drugs. Expectation or placebo plays a significant role in whether or not these drugs will help an individual “overcome” their depression. Peter Kramer continues to hold on to a narrative that the chemical properties of SSRIs actually do help some depressed individuals, with “little of the benefit coming from the classical placebo effect.” But in debunking the science used to affirm the antidepressant placebo effect, he also calls into question the methods used to approve those same SSRIs in the first place.

What about Peter Breggin? He’s still around and critiquing the use of other classes of psychiatric drugs as well as antidepressants. He was recently the expert witness in a 2016 court case, awarding $11.9 million in a Paxil suicide malpractice case. He has a video series on YouTube, “Simple Truths About Psychiatry,” which is also linked on his website: breggin.com. There is plenty of additional material there to support the ineffectiveness and danger of antidepressants. In 2011, Dr. Breggin was the expert witness in a court case where Prozac was found to be a contributing factor to the murder of a teenager by his friend. “This was the first criminal case in North America where a judge has specifically found that an antidepressant was the cause of a murder.”

There’s more discussion of Irving Kirsch and the placebo effect here on my website. Start with: “Dirty Little Secret” or do a search of the website for his name.

10/18/16

Dancing with the Devil

© choreograph | stockfresh.com

© choreograph | stockfresh.com

I once knew a woman who had an anxiety disorder. She also abused benzodiazepines. She was able to conjure up a panic attack in a doctor’s office and walk out with a prescription for the benzo of her choice. At one time, she had four concurrent prescriptions for these anti-anxiety medications. Another person I know of has a ten-year history of using benzodiazepines at close to the maximum recommended dose. When he had an unexpected short-term hospital stay, the treating physicians were reluctant to continue prescribing benodiazepines at such a high level while he was in the hospital. When he returned home, in case his medical issue resulted in another unexpected stay, he put together an emergency hospital kit with various things—including extra benzodiazepines.

A study published in the American Journal of Public Health in April of 2016 found that benzodiazepines were the second most common drug in prescription overdose deaths for 2013. Given the common knowledge of the potential dangers of benzodiazepines and people becoming more aware of opioids, Marcus Bachhuber and a team of researchers thought that their study would show a steady of declining pattern for prescribing benzodiazepines. But they found exactly the opposite. Between 1999 and 2013 there was an increase of 30% among adult Americans who filled a benzodiazepine prescription. In addition, the amount of medication within a prescription doubled over the same time period.

Bachhuber was quoted by CNN as saying the study’s findings were very concerning. The risk of overdose and death from benzodiazepines alone is said to be generally lower in otherwise healthy adults. But in combination with other drugs like alcohol or opioids, they can be lethal.

Future research should examine the roles of these potential mechanisms to identify effective policy interventions to improve benzodiazepine safety. In particular, as underscored by several recent reports, interventions to reduce concurrent use of opioid analgesics or alcohol with benzodiazepines are needed.

The overdose problem with benzos has been overshadowed by the problems with prescription opioids. Writing for CNN, Carina Storrs said: “The current study could help shine a light on the problem of benzodiazepine abuse and overdose.” Dr. Gary Reisfield, a professor of psychiatry at the University of Florida, referred to the problem with benozdiazepines as a “shadow epidemic”:

Much attention has been paid to the explosion of prescription opioid prescribing and the associated morbidity and mortality. Much less attention has been paid to the shadow epidemic of benzodiazepine prescribing and its consequences.

A 2015 study by Jones and McAninch found that emergency department visits and overdose deaths involving opioids and benzodiazepines increased significantly between 2004 and 2011. Overdose deaths from combining the two classes of drugs rose each year from 18% in 2004 to 31% in 2011. This rate increased faster than the percentages of people filling prescriptions and the quantity of pills in the prescriptions.

As Dr. Indra Cidambi wrote in “Are We Ignoring an Escalating Benzodiazepine Epidemic?”,  she observed with increasing alarm the rising rate of concurrent use/abuse of benzos among opiate users. She pointed to two possible factors driving this trend. First, some opiate abusers use benzos to “spike” the euphoria from their opiates. Second, patients often receive their prescriptions from two different physicians. She said that it is “notoriously difficult” for doctors to refuse to prescribe these two medications.

Unfortunately, and ironically, pain and anxiety are neither verifiable nor quantifiable through medical testing! Consequently, self-reported symptoms by patients are the sole basis on which prescriptions for these medications are written, enabling individuals addicted to these medications to obtain them fairly easily.

Dr. Cidambi recommended the establishment of a national database for physicians to verify whether or not a patient has been prescribed one of these medications before prescribing or filling a prescription for the other. Second, she said physicians should develop limited, short-term treatment plans from the beginning to treat noncancerous pain with opiates and anxiety with benzodiazepines.

Studies have shown the decreasing efficacy of long-term treatment for pain with opioid medications, and evidence-based treatment protocols for benzodiazepines clearly indicate that long-term use of benzodiazepines is not recommended.

In “Benzos: A Dance with the Devil,” Psychiatrist Kelly Brogan described some of her work helping patients taper off of benzodiazepines. A woman who had been placed on Remeron (an antidepressant) and Klonopin (a benzodiazepine) for eight years said of her original prescriber: “He never once told me there might be an issue with taking these meds long-term. In fact, he told me I probably needed them after I tried stopping them cold turkey and felt so sick I thought I was dying.” Brogan said no one ever discussed with this woman or her patients the true risks, benefits and alternatives to psychiatric medications like benzodiazepines, “perhaps because we as clinicians are not told the full story in our training.”

She went on to quote from a paper by another psychiatrist, Peter Breggin, on the risks of benzodiazepines, which include: cognitive dysfunction that can range from short-term memory impairment and confusion to delirium; “disinhibition or loss of impulse control, with violence toward self or others, as well as agitation, psychosis, paranoia and depression.” There can also be severe withdrawal symptoms, ranging from anxiety and insomnia to psychosis and seizures after abruptly stopping long-term larger doses. The person can re-experience their pre-drug symptoms as they taper. These so-called rebound symptoms of anxiety, insomnia and others serious emotional reactions can be more intense than they were before drug treatment began. And don’t forget dependency or abuse.

Psychiatrist Allen Frances, the former chair of the DSM-IV, recently wrote: “Yes, Benzos Are Bad for You.” He introduced his article by saying that he was going to say some very negative things about benzodiazepines in the hope that doctors think twice before prescribing them and patients are discouraged from taking them. Benzos were wonder drugs in the 1960s. Anyone remember the 1966 song, “Mother’s Little Helper,” by the Rolling Stones? These drugs were reputed to be safe, and so were used for a variety of “ills,” such as anxiety, alcohol use disorders (yes, really), to take the edge off of agitation in dementia, and to help people sleep. “Initially we were pretty oblivious to the risk of addiction.” So benzodiazepines quickly became the most prescribed medications in America.

A second craze began in the 1980s with the release of Xanax. Frances said the dose to treat panic disorder was “dangerously close” to the dose leading to addiction. “This should have scared off everyone from using Xanax, but it didn’t.” It remains a best seller, with its own “brand” that now leads to fentanyl be pressed into counterfeit Xanax pills. See “Buyer Beware Drugs” and Paul Gaita’s article on fake Xanax laced with fentanyl.

The real wonder of the benzos is that sales continue to boom, despite their having so little utility and no push from pharma marketeering (because patents have run out – thereby decreasing costs and profits.) Between 1996 and 2013, the percentage of people in the U.S. using benzos jumped more than one-third from an already remarkable 4.1 to 5.6 percent. Especially troubling is that benzo use is ridiculously high (nearly one out of ten) in the elderly, the group most likely to be harmed by them.

Frances said the beneficial uses of benzodiazepines can be counted on the fingers of one hand: short-term agitation in psychosis, mania and depression; catatonia; “as needed” use for times of special stress, like fear of flying, or for sleep. While they should be used very short term, in real life most people take them long term—“in doses high enough to be addicting, and for the wrong reasons. . . . Benzos are very easy to get on, almost impossible to get off.”

In addition to the harm from overdoses, Frances described the painful and dangerous withdrawal symptoms, which he said are a “beast.” Common symptoms are irritability, insomnia, tremors, distractibility, sweating and confusion. “The anxiety and panic experienced by people stopping benzos is usually much worse than the anxiety and panic that initially led to their use.”  Concurrent use or abuse of alcohol or other drugs, like opioids, complicates withdrawal even further.

The most insidious issues with benzos for Frances, is how they effect brain functioning. Especially with the elderly, ongoing benzo use can be devastating. Many elderly begin their downward spiral to death and disability from falls—that happen from their benzo use! He said: “If you meet an elderly patient who seems dopey, confused, has memory loss, slurred speech, and poor balance, your first thought should be benzo side effects — not Alzheimer’s disease or dementia.” See “Sedating Seniors” for more information on this topic. It’s been over 30 years since he last prescribed a benzo for anxiety.

The tough question is what to recommend for those many unfortunates already suffering the tyranny of benzo addiction. Should they stay the course to avoid the rigors and risks of withdrawal or should they make the great effort to detox? This is an individual decision that can’t be forced on someone. But the longer you are on them, the harder it gets to stop, and the cognitive side effects of benzos create more and more dysfunction as your brain ages. The best bet is to stick with a determined effort to detox, however long and difficult, under close medical supervision. On a hopeful note, some of the happiest people I have known are those who have overcome their dependence on benzos.

So it was encouraging to see that the FDA will require class-wide changes in drug labeling to bring attention to the dangers of combining opioids and benzodiazepines. The changes will include boxed warnings on nearly 400 products with information on the risks of combining these medications. The FDA Commissioner, Robert Califf said: “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together.” He implored health care professionals to carefully and thoroughly evaluate on a patient-by-patient basis whether the benefits outweigh the risks when using these drug classes together.

Used alone or in conjunction with opiates, benzodiazepines are potentially lethal and addictive. A too sudden withdrawal from benzodiazepines can be fatal, where the same is rarely true with opiates. They work quickly and effectively for anxiety and sleep problems and yet they can have a multitude of side effects, including addiction. Did I say they are addictive? Using benzodiazepines has become a dance with the devil for too many unsuspecting individuals … those that are still alive to regret it, that is.

This article previously appeared on the addiction and recovery website “The Fix” under the title of “Dangerous Dance.”

09/20/16

Appalling Silence on ECT

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© rangizzz | 123rf.com

Kenny was put on antidepressants at the age of 14 because he was struggling in a difficult family situation. His symptoms became worse. The psychiatrist added another drug with again worsening symptoms. At one point, he was taking six different psychiatric drugs. Kenny was eventually told his depression was “treatment resistant” and needed electroshock therapy.  “The risks were downplayed.” He was given 30 rounds of ECT and went from a high school honor student to having to be retaught how to tie his shoes. Wait, there’s more!

Kenny lost all memories of childhood and all memories of high school. He says it’s an identity crisis. He suffered severe headaches for a year and a half after the shocks and had to see a cardiologist because ECT left him with heart arrhythmia. Testing by a neurologist, done six months after the shocks, showed a loss of 50 IQ points compared to his high school IQ. Kenny still suffers from night terrors about the shocks.

Dr. Langemann’s article on “Shock Therapy” for the Huffington Post also referred to a biomedical engineer who said the “brief pulse” of ECT is actually a series of several hundred pulses, and not a single pulse. These pulses overstimulate brain cells, causing rapid random firing, intentionally causing a Grand Mal seizure. “The current causes overheating inside the brain and the electric field can tear holes in the cells (which causes the cells to die).” She noted that a conservative estimate is that 100,000 patients per year receive ECT.

Incredibly, ECT has never been through the standard clinical trial process to prove its safety or efficacy. Although the FDA has had the authority to regulate medical devices since 1976, it disregarded ECT machines because they’ve been in widespread use since the 1950s, according to STAT News in “Psychiatric Shock Therapy.” The FDA placed ECT machines in the class III (high risk) category where they have remained since that time. But in December of 2015, the FDA made public a draft document proposing to reclassify ECT machines as a class II (low risk) device. Before the public comment period ended in late March of 2016, the FDA had received 2,040 comments on its draft rule. The agency has not set a timetable for issuing its final ruling.

While the proposed regulations would indicate that ECT was “safe and effective” and only moderately risky for adults, it would only be approved for adults with severe depression who haven’t responded to medication or other therapies. It would remain classified as a high risk  (class III) for psychiatric conditions other than major depression and for children and adolescents. There would be new requirements as well. Doctors would have to warn patients of the side effects of ECT, which include confusion and memory loss; and that long-term safety for ECT is not proven.

Psychiatrists warn that that these new regulations could lead to insurers not covering ECT and doctors not recommending it for younger patients and those with conditions like schizophrenia, bipolar disorder and catatonia. (They say it like that’s a bad thing) Charles Kellner, a professor of psychiatry at the Icahn School of Medicine said, “Its use for these indications is widespread, even ubiquitous, and to deny the extensive evidence in support of that is indefensible.” Supporters say ECT has come a long way since it was portrayed in “One Flew Over the Cuckoo’s Nest.” Patients get anesthesia and sedatives to minimize pain and muscle spasms, so they are less likely to hurt themselves during the ECT seizure. “Ultra-brief pulse therapy delivers a fraction of the electricity used in the past.” However, as noted above, this claim is disputed. See “The Frankenstein Monster of ECT” and “Is ECT Brain Disabling?” on this website.

Writing for GlobalResearch, Dr. Gary Kohls described ECT “therapy” sessions as: “sub-lethal electrocutions of the brain that reliably produces seizures and coma.” He noted that the perceived improvement with ECT is often because of the frequent short-term and long-term memory loss that occurs with shock treatment. “The patient may no longer remember the traumatizing interpersonal/sexual/social/ psychological/spiritual conflicts that previously made them feel sad, nervous, depressed, anxious or hopeless.” He lamented that studies show physicians reach for their prescription pad within minutes of most clinic encounters. “Time is money.”

Dr. Kohls then quoted excerpts from the testimony of Leonard Roy Frank before the Mental Health Committee of the New York State Assembly in 2001. Mr. Frank was a psychiatric survivor and activist who personally experienced 35 ECT procedures and 50 insulin coma treatments. The transcript of his testimony can be read here in its entirety. He said:

This was the most painful and humiliating experience of my life. My memory for the three preceding years was gone. The wipeout in my mind was like a path cut across a heavily chalked blackboard with a wet eraser. Afterwards I didn’t know that John F. Kennedy was president although he had been elected three years earlier. There were also big chunks of memory loss for events and periods spanning my entire life; my high school and college education was effectively destroyed. I felt that every part of me was less than what it had been.

Frank then elaborated on some of the adverse effects from ECT. With regard to memory loss, he indicated that the APA downplays memory loss, saying most patients actually report improved memory; and only a minority of patients report problems with memory loss. He said the vast majority of individuals he has talked to reported moderate-to-severe amnesia going back two years and more from the time they received ECT.  His own experience was noted above.

Quoting the 2001 APA Task Report on ECT, Frank noted where a reasonable ECT-related mortality rate was suggested to be 1 per 10,000 patients. However, some studies show the ECT death rate is about one in 200. This rate may not still be accurate, as an increasing number of the elderly are being electro shocked. “Statistics based on California’s mandated ECT reporting system indicate that upwards of 50 percent of all ECT patients are 60 years of age and older.”

Frank described what he referred to as “the myth of informed consent.” While outright force is seldom used, “genuine informed consent is never obtained” because ECT specialists minimize the procedure’s nature and effects to candidates and their families; and because of the implicit coercion that can be brought to play. There is a lack of accountability with psychiatry. It was a “Teflon” profession, meaning what little criticism there is doesn’t stick. “Psychiatrists routinely carry out brutal acts of inhumanity and no one calls them on it — not the courts, not the government, not the people.”

Electroshock could never have become a major psychiatric procedure without the active collusion and silent acquiescence of tens of thousands of psychiatrists. Many of them know better; all of them should know better. The active and passive cooperation of the media has also played an essential role in expanding the use of electroshock. Amidst a barrage of propaganda from the psychiatric profession, the media passes on the claims of ECT proponents almost without challenge. The occasional critical articles are one-shot affairs, with no follow-up, which the public quickly forgets. With so much controversy surrounding this procedure, one would think that some investigative reporters would key on to the story. But it’s happened only rarely up to now. And the silence continues to drown out the voices of those who need to be heard. I’m reminded of Martin Luther King’s 1963 “Letter from Birmingham City Jail,” in which he wrote: “We shall have to repent in this generation not merely for the vitriolic words and actions of the bad people, but for the appalling silence of the good people.”

Psychiatrist Peter Breggin has advocated against ECT for decades. You can watch an 11-minute video he did called, “Electroshock is Brain Trauma.” He indicated the 100,000 per year estimate for ECT was based on data he gathered in 1979 for his book critical of shock treatment. He said today every large city has several places that do shock treatment. “It’s extremely remunerative.”

Dr. Lagemann indicated that standard treatment is 9 to 12 shocks, at a cost of $2,000 to $2,500 each. When you do the math, you come up with a minimum income of $1.8 billion (9 x 100,000 x $2,000 = $1.8 billion). About half the cost is covered by Medicare. Mr. Frank indicated that in 2001, psychiatrists specializing in shock treatment earned $300,000-$500,000 a year compared to other psychiatrists whose mean annual income was $150,000.

What’s wrong with shock treatment? How does it work? It’s not as mysterious as the advocates make out. Shock works by passing an electric current through one or both frontal lobes of the brain, producing an electrical lobotomy.  The electricity also passes through the memory centers of the temporal lobe, causing additional devastation. Finally, the current passes throughout the brain and that, along with the severe seizures that result, causes widespread brain dysfunction and damage. Some patients initially become euphoric from the damage, whereupon the shock doctor notes approvingly, “mood elevated.” All patients eventually become apathetic and indifferent, and unable to resist, whereupon the doctor notes with finality about the outcome, “no longer complaining.”

Dr. Breggin said the only reason that modern shock doctors don’t talk about ECT as damaging the brain is because he publicized and documented how it was in his book, Electroshock: Its Brain-Disabling Effects. He noted that when ECT treatment is done, it results in a period of coma. “How could a blow to the brain with electricity so severe it causes a coma, and you’re not harmed by it?” Very often the EEG brain waves flat line—that’s temporary brain death. The person wakes up completely disoriented. The longer the treatment continues, the more past memory the person loses.

The STAT News article noted where a woman who had 66 ECT treatments between 1996 and 2010 to treat depression left such holes in her memory that she couldn’t recall her wedding day or the birth of her children. Her 28-year marriage ended, ““because I couldn’t remember that relationship, and without those memories, I had no emotional connection.”

Dr. Breggin created a free website about shock treatment: ECT Resources Center.  Among its documents is a simple introductory statement and brochure for widespread distribution. There are also PDFs of more than 100 scientific articles on issues with ECT. He urged people to do everything they can to stop someone they know getting ECT, because they will never be the same afterward.

As of September 1st, there has not been an announcement of what the FDA plans to do with ECT. But when the FDA announced it was soliciting comments of the proposed regulatory changes, the American Psychiatric Association created a form letter for psychiatrists to “take the lead in expressing their views” regarding the role of ECT in clinical practice and treating major depressive disorder. See “Time is Now to Support the ECT Reclassification Effort.” The letter asserted that ECT was an important treatment option for some people with severe mental health conditions. “Your proposed reclassification will greatly improve access to safe, effective treatment for individuals with serious and persistent psychiatric disorders.” You can download and read a copy of the form letter in the above link. I wonder how many of the 2,040 comments were APA form letters from psychiatrists?

07/1/16

Misleading Info on ADHD

© Ivelin | stockfresh.com

© Ivelin | stockfresh.com

Three Swedish researchers did a study on the information published online by the National Institute of Mental Health (NIMH) on ADHD. What is intriguing about their study is that they were looking at how the NIMH document sought to persuade its readers to take action to address their child’s ADHD problem. They suggested there was a circular argument wherein ADHD was defined according to the presence of certain behaviors, which the diagnostic label of ADHD was said to explain. They also pointed out how ADHD is presented as legitimate medical disorder, despite the fact that “diagnostic criteria are subjectively interpreted from the behavior of the child.”

The authors, Erlandsson, Lundun and Punzi, linked this Easy-to-Read NIMH document on ADHD in their study. However, their citations appear to be from this NIMH document, “What is Attention Deficit Hyperactivity Disorder (ADHD, ADD)?” They noted where the image of ADHD as a legitimate medical disorder was established by the first sentence of the article, “ADHD is one of the most common childhood disorders [and can continue through adolescence and adulthood].” This is word-for-word in the latter article, where the Easy-to-Read one is slightly different: “ADHD is a common mental disorder that begins in childhood and can continue through adolescence and adulthood.” The bracketed phrase was not quoted by Erlandsson, Lundun and Punzi, possibly because they were looking at ADHD in children; or when they examined the document in October of 2015, it wasn’t there.

Erlandsson et al. noted how the repeated use of the term “disorder” (at least 15 times) and a number of references to brain imaging and brain chemicals gave the impression of a chronic, long-term disability.  The rhetoric is clearly suggestive that ADHD is a brain disorder. And yet, because symptoms vary from person to person, the ‘disorder’ can be difficult to diagnose. The so-called ‘key behaviors of ADHD’ are also found in all children—inattention, hyperactivity, and impulsivity. “But for children with ADHD, these behaviors are more severe and occur more often.” They have to be present for at least six months, and be present to a degree “that is greater than other children of the same age.” Erlandsson et al. said:

In fact, as shown in the document, there are no biological markers, environmentally defined categories, or objective tests to distinguish “ADHD” as a discrete condition. Rather, diagnostic criteria are subjectively interpreted from the behavior of the child: “No single test can diagnose a child having ADHD. Instead, a licensed health professional needs to gather information about the child, and his or her behavior and environment.” Professionals as well as teachers and parents are involved in the evaluation and examination process, and subsequently in the diagnostic process.

There is a clear bias in presenting ADHD as a biomedical problem. While saying scientists aren’t sure what causes ADHD, NIMH then said many studies suggest genes play a large role. Twin studies show ADHD runs in families. “Children with ADHD who carry a particular version of a certain gene have thinner brain tissue in the areas of the brain associated with attention.” But the differences were not permanent and as the children with this gene grew up, the brain developed to a normal level of thickness and the ADHD symptoms improved. As Erlandsson et al. commented: “The biomedical discourse assumes that there is a consensus among professionals on how to interpret the behaviors of the child, which means that pharmacological treatment is the preferred intervention.” But this is not the case.

In “ADHD: an Imbalance of Fire over Water or a Case of the Fidgets?” I reviewed several different sources questioning whether ADHD was a biochemical disorder. Psychiatrist Peter Breggin said the search for a genetic and biological cause for ADHD would never succeed because the researchers are looking in the wrong place. Neurologist Fred Baughman said:

 Despite regular pronouncements that its biologic roots have been discovered, no proof of a definite physical or chemical abnormality is ever found. All such research and all such claims … have been a sham, meant to create illusions of science and disease while proving nothing.

The NIMH material also did not mention there was a lack of consensus on the safety of using medication to treat children. Rather, medication is said to be a safe treatment:  “Under medical supervision, stimulant medications are considered safe.” The potential for substance abuse or dependence is downplayed, saying: “there is little evidence of this.” ADHD stimulants are classified as Schedule II controlled substances, which have “a high potential for abuse, with use potentially leading to severe psychological or physical dependence.” See “ADHD: an Imbalance of Fire over Water or a Case of the Fidgets?” for more information on ADHD medications and addiction.

The consequences of a biomedical view of ADHD were addressed in a recent study by the CDC of ADHD treatment among children between 2 and 5 years of age. While the American Academy of Pediatrics and other organizations recommend behavior therapy ahead of stimulant medication for children under 5, only 53% of children had received behavior therapy in the year prior to the survey, while 47% had received stimulant medication during the previous week.  Between 75% and 78.5% of children aged 2-5 with ADHD received one or more ADHD medications.

ADHD is a highly prevalent condition that can lead to poor health and social outcomes. Despite 2007 and 2011 guidelines recommending behavior therapy as first-line treatment for children aged <6 years with ADHD, during 2008–2014 only about half of children aged 2–5 years with ADHD received psychological services. To effectively mitigate impairments associated with ADHD and minimize risks associated with ADHD medications, it is important to increase the percentage of young children with ADHD who receive evidence-based psychological services, especially parent training in behavior therapy.

Around 30% of children aged 3-5 experienced adverse effects from ADHD medications. The most common ones were appetite suppression and sleep problems. But other commonly reported side effects were: abdominal pain, emotional outbursts, irritability, lack of alertness, repetitive behaviors and thoughts, social withdrawal, and irritability when the medication wears off. In one large study, of methylphenidate (Ritalin or Concerta) over 10% of children 3-5 had to stop treatment because of adverse effects. They were also 20% lower for height and 55% lower for weight. Anne Schuchat, the CDC’s Principle Deputy Director, said:

We are still learning about potential side effects of long-term use of ADHD medicine on young children. Until we know more, the recommendation is to refer parents for training in behavior therapy for children under 6 years of age with ADHD.

We recognize that these are not easy treatment decisions for parents to make. We know that behavior therapy is effective, and the skills they learn through behavior therapy can help the whole family be successful. Building these skills in parents and children both empowers families and helps young children with ADHD live up to their full potential.

An article in The Washington Post, “CDC Warns that Americans May Be Overmedicating Youngest Children with ADHD,” addressed this concern as well. The long-term effects of the drugs of choice for treating ADHD, Adderall and Ritalin, were not well studied. An estimated 2 million of the 6 million children diagnosed with ADHD were so labeled between the ages of 2 and 5. While ADHD medications don’t work for everyone, in many cases they take effect almost immediately. In contrast, behavior therapy can take several months to have an impact. However, it can be long lasting; and has no side effects.

06/21/16

Now There’s Chewable Speed

© vogelsp | 123rf.com

© vogelsp | 123rf.com

Do you have a difficult time giving your child ADHD medication? Not that you don’t want them to take it—you do. But they don’t like the taste; or they have problems swallowing pills; or they just don’t like how it makes them feel. Or maybe you’re an adult who chronically forgets to take your medication in the morning. You don’t want to carry a prescription bottle around with you. People may wonder why you are popping pills in the middle of the day. Now there is an ADHD medication that is right for you! It’s chewable and comes in fruit flavors too!

Okay, the paragraph above was a tad satirical, but it is entirely true in what it said about ADHD medication. In mid-May of 2016, Adzenys, a chewable, fruity form of amphetamine became available. As STAT reported, Adzenys XR-ODT was approved by the FDA in January of 2016 by the FDA for patients six and older. The CEO of Neos Therapeutics said they were “launching now at full speed.” They want to get “ahead of back-to-school season.”

Vipin Garg, the CEO of Neos, said the new quick-dissolving formula will help “harried mothers” get their children medicated faster in the morning before school. And if adults forget to take their pill at breakfast, they can “pop a tablet” on the way to work—it comes in a blister pack, not in a pill bottle. “You go to a pharmacy, and everything is in gummy bear format. . . . Why would that be the case if there wasn’t a need for this?” Garg sees the dissolving tabs as part of a trend to make medications more pleasant to take.

All that adds up to a booming market. Sales for ADHD medications were at $4.7 billion in 2006, had nearly tripled to $12.7 billion by last year, and are projected to grow to $17.5 billion by 2020, according to a 2015 report from market research firm IBISWorld.

Adzenys is not alone as a chewable ADHD medication. In December of 2015, one month ahead of Adzenys, the FDA approved QuilliChew for Pfizer. Similar to Adzenys, it is an extended release tablet and was approved for patients six and older. The tablet is even scored, so it can be easily halved to individualize the needs of the patient taking it. The active ingredient in QuilliChew is methylphenidate hydrochloride.

Ann Childress, the president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, was quoted by Medscape as saying: “As a physician, it is important to have treatment choices for patients with ADHD and their caregivers. QuilliChew ER extended-release chewable tablets give healthcare providers an additional treatment option to meet their patients’ needs.”

Dr. Childress was a paid consultant and spokesperson for Pfizer according to ProPublica. Between August 2013 and December of 2014 she received $25,911 for “consulting”, “promotional speaking/other” “travel and lodging” by Pfizer for activities related to Quillivant XR. Looking at the archived data on ProPublica, she has had a speaking, consulting and research relationship with Pfizer for several years. She has also been paid $17,998 during the same time period for consulting and other activities by Shire, which makes Vyvanse, another ADHD medication.

Shire recently applied to the FDA to be allowed to bring a chewable Vyvanse to market. On April 14, 2016 Shire announced they had submitted a new drug application to the FDA for a chewable tablet version of Vyvanse for individuals who may have problems swallowing or opening a capsule. The existing Vyvanse capsules can be swallowed whole or opened so that the medication can be mixed into food or water. “Vyvanse chewable tablets will offer an additional administration option for patients.”  The proposed indications for chewable Vyvanse would be the same as the existing uses for Vyvanse capsules—ADHD and Binge Eating Disorder. By the way, sales for Vyvanse more than doubled between 2010 and 2014, from $986 million to $2.1 billion.

Opinions are mixed on the new chewable formulas, according to STAT.  Dr. Ben Biermann, an assistant professor of psychiatry at the University of Michigan, thought there was nothing revolutionary about Adzenys. “It’s simply another delivery mechanism for a medication that already exists and has widespread use.” On the other hand, Dr. Mukund Gnanadesikna, a child and adolescent psychiatrist in Napa, California, thought it was a recipe for people to request it and then sell it: ““I’m not a big fan of controlled substances that come in forms that can be easily abused — and certainly a chewable drug falls into that category.”

Both Adzenys and Vyvanse are amphetamines, as is Adderall. Quillivant and Quillichew are methylphenidate, as are Concerta and Ritalin. All ADHD stimulants are Schedule II controlled substances, meaning they have a high potential for abuse and dependence. And there are multiple potential issues when using stimulants. Here are some of the precautions noted on the Adzenys-XR-ODT medication guide: serious cardiovascular reactions including sudden death, stroke and myocardial infarction; adverse psychiatric reactions such as psychosis or mania. Other adverse reactions can include insomnia, loss of appetite, nervousness, weight loss, and agitation.

The existing and potential harm to children from stimulant medications like Adzenys and Quillichew are well documented and described by Dr. Peter Breggin on his website, breggin.com. He said too many children grow up believing they are inherently defective. The latest scientific literature indicates the potential consequences of boys aged 7-9, who were given a diagnosis of mild hyperactivity in the 1970s and treated with Ritalin. Those boys have much higher rates of early death, atrophy of the brain, suicide, psychiatric hospitalization incarceration and drug addiction than a control group of children from the same time period.

Breggin gave multiple reasons for these potentially dreadful outcomes, including the misinterpretation of adverse effects like depression, anxiety, agitation, insomnia psychosis and aggression. Instead of seeing these as adverse drug reactions, they are viewed disorders that were “unmasked” by the stimulants, which leads to further prescriptions to deal with these newly uncovered mental disorders. Embedded in his linked page are several videos he has done that explain the harmful effects and method of action of stimulants; the negative effects of diagnosing children with ADHD; and the long term consequences to children using stimulants like Ritalin.

There is more information available on the problems with ADHD medications and ADHD diagnosis on this website. Try  “A Drug in Search of a Disorder”, “Pseudoscience with Vyvanse?” or “ADHD: An Imbalance of Fire over Water or a Case of the Fidgets?” Also try a search of “ADHD.”

06/10/16

Psych Drugs and Violence

© stocksnapper | stockfresh.com

© stocksnapper | stockfresh.com

A man began taking Zoloft because of some anxiety over whether he could cope with high school students as a student teacher. By the second day on Zoloft, he was having delusions. By day three, he believed aliens were hiding in the normal bodies of people all around him. He thought the alien leader had taken over his wife’s body. On the seventh day of Zoloft, he became certain that he had to kill the alien inside his wife to save himself and the world. So he drove their car full speed into a road barrier, unbuckling her seatbelt just before the crash. Finding her lying on the ground and alive after the wreck, he began to bang her head against the concrete and choke her. His wife survived, but their marriage did not.

A psychiatrist with a successful practice was stressed because of difficulties that ended up with him taking another psychiatrist to court. She in turn sued his son, who was involved in the business.  He prescribed himself Prozac hoping to relieve some of his tension and raise his spirits, but that didn’t help. He sought out treatment from another psychiatrist who treated him with more antidepressants, which led to further deterioration. Eventually he was placed on Luvox—the same antidepressant one of the Columbine shooters was taking. He became increasingly incensed at the psychiatrist who countersued his son and attacked her with a tack hammer.

These are just two of the case studies described by psychiatrist Peter Breggin in his book, Medication Madness. However, you don’t have to read it to find further examples. Read about the speculation after the Sandy Hook shootings about Adam Lanza. Or read this 2010 article by Moore, Glenmullen and Furberg, “Prescription Drugs Associated with Reports of Violence Toward Others.” Thirty-one different drugs met the study’s criteria for a disproportionate association with violence. The drugs included 11 antidepressants, 5 hypnotic/sedatives, 3 ADHD drugs and varenicline (Chantix). “SSRI Stories” describes over 6,000 stories where it seems prescription drugs  (primarily SSRIs) were linked to adverse outcomes, including violence. Also look at “Drugs, Violence and Revolution” or “Smoke and Mirrors” on this website.

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.

Several years ago I attended a conference and heard a presentation by Yolande Lucire on her research into the association of violence and psychiatric medications.  At the time I found her presentation both fascinating and concerning in that she thought she had identified a biomedical association between antidepressant medications and some perpetrators of violence. Could there actually be medical evidence of an association between antidepressants and violence? But I didn’t hear anything more about this finding, despite the parade of case studies and anecdotes like those above that did suggest a connection. Then I saw where she was the coauthor of an article in the April 2016 issue of Forensic and Legal Medicine, describing a forensic investigation of three individuals who committed homicide, two of which also intended suicide while taking antidepressants.

The article by Eikelenboom-Schieveld, Lucire and Fogleman was a forensic investigation of three cases they believed to be instances of antidepressant-induced akathisia-related homicide. They suggested that mutations in the CYP450-encoding genes of these individuals contributed to problems metabolizing psychiatric medications and were thus contributing factors to their homicides. The cytochrome P450 family of enzymes is responsible for metabolizing most of the drugs used in psychiatry. “These individuals also had diminishing mutations in the CYP450 family of metabolizing enzymes and all were taking medicines that further decreased metabolism by inhibition.”

None of the three individuals knew they were supposed to take their medication regularly or how to stop taking it safely; and none of them improved on the medications. In addition, none of the prescribers recognized their complaints as adverse drug reactions. Nor were they aware of any impending danger from their patients. Interviews with the individuals indicated they had struggled with akathisia (agitation or distress), confusion, delirium, euphoria, extreme anxiety, obsessive preoccupation with aggression, and an incomplete recall of events. Impulses to kill were acted on without warning. Upon recovery, they all saw their actions as out of character. Their beliefs and behaviors horrified them.

They were all prescribed medications that interacted with one another and one person combined these with alcohol. The drug-to-drug interactions further decreased their metabolizing capacity and increased their risk for adverse events by prolonging the half-life of the medications and raising their blood levels.

Fast-changing levels of psychotropic substances, up or down, can cause behavioural changes, as the neurotransmitters in the brain react to reach some equilibrium. This phenomenon makes starting and stopping medication the most dangerous times for suicide and violence, but both can happen at any time, with stress, provocation, dose change, addition or subtraction of a medication. These toxic responses to antidepressants may occur early or later in treatment.

When reading this paper, I saw that Dr. Lucire had previously published an article in 2011 on anti-depressant-induced akathisia-related homicide and the CYP450 genes. In Lucire and Crotty they found that CYP450 allele frequencies were higher in those individuals who had experienced akathisia/serotonin toxicity after taking psychiatric medications. They presented ten cases whose the use of antidepressants had not mitigated their distress. Every person’s emotional reaction worsened while their treating physician attempted a “trial and error” method of increasing doses and then changing to another antidepressant when the previous one did not work.

The symptoms of antidepressant drug toxicity were not recognized as such by the subjects or their physicians. In many cases, the dosage of the antidepressant was increased while other medications were given to address the side effects Frequently the adverse effects were compounded.

In some cases the violence ensued from changes occasioned by withdrawal and polypharmacy. In all of these cases, the subjects were put into a state of drug-induced toxicity manifesting as akathisia, which resolved only upon discontinuation of the antidepressant drugs.

This paper has detailed and substantiated in specific terms how the metabolism of each of the antidepressant drugs used by the subjects would have been seriously impaired both before and at the time they committed or attempted homicide. They were experiencing severe reported side effects, adverse drug reactions due to impaired metabolism complicated by drug–drug interactions against a background of variant CYP450 alleles.

Eikelenboom-Schieveld, Lucire and Fogleman concluded that CYP450 was an important factor for determining who could tolerate a drug or combination of drugs from who could not. “Testing for cytochrome P450 identifies those at risk for such adverse drug reactions.” They hoped that as awareness of the biological causes of these disastrous side effects became more known, justice would be better served for both the victims and perpetrators of akathisia-related violence. “The medicalization of common human distress has resulted in a very large population getting medication that may do more harm than good by causing suicides, homicides and the mental states that lead up to them.”