07/9/24

Coming Up Short with Adderall and Other ADHD Drugs

Since the FDA first announced a national shortage of Adderall in October of 2022, the shortage has now spread to other ADHD medications such as Focalin, Ritalin, Vyvanse, and others. There are an estimated 10 million adults and 6 million children diagnosed in the U.S. with ADHD who are struggling to fill their prescriptions. Medscape said this is especially challenging for people living in rural and underserved areas. The drug shortage is now into its second year, with no apparent end in sight, begging the question how did we get here?

Medscape noted that manufacturers and federal agencies have blamed the rising demand and shortages on each other. Clinicians added that insurers contribute to the shortages by requiring patients to try one, two or three medications before they authorize a more expensive or newer drug like Vyvanse. Congress has also pressured the DEA and the FDA to explain the continuing ADHD medication shortages.

In August of 2023 the DEA and the FDA publicly blamed the manufacturers for the shortages, claiming they were not using up their quotas for the production of controlled substances. Citing CDC data, the agencies claimed when virtual prescribing was widely permitted in 2020-2021 because of the COVID pandemic, prescriptions increased by 10%. Tele-health startups took advantage of an emergency provision during the pandemic that allowed healthcare providers to prescribe controlled substances like ADHD medications via tele-health. They also took advantage of a treatment loophole in diagnosing adult ADHD.

Although there are guidelines for diagnosing and treating children with ADHD, there are no guidelines for adult ADHD in the US. This meant adults can self-diagnose themselves with ADHD after watching some TikTok videos, describe the largely subjective symptoms to their doctor, and get a prescribed stimulant, which they could then use as a study aide or for cognitive enhancement. See “Is Adult ADHD the Latest Fad Diagnosis?”

The failure of manufacturers to increase their production of ADHD medications to meet the increased demand is puzzling. The DEA estimated that drug makers only sold about 70% of their allotted quotas in 2022, “leaving almost 1 billion tablets un-made and un-sold” in the midst of the ADHD shortage. The DEA and FDA agencies said they called on manufacturers to confirm they are working to increase production to meet their allotted quota amount. If they did not want to increase their production, they would be asked to give up their remaining 2023 quota allotment “so it could be redistributed to a drug maker that would increase production.”

According to the American Society of Health-System Pharmacists, some manufacturers have inexplicably discontinued making immediate and/or extended-release ADHD pills, while others gave no reason for their shortage or refused to comment. This has led some impatient adults to turn to online black markets, searching there for “study help” or “study aids.” The Guardian noted where search terms such as “NFL” or “footballs” are also effective, since a 30mg Adderall tablet vaguely resembles a regulation American football.

But legitimacy on the black market is a huge problem. Since the medication shortage began, underground pills sold as Adderall have been found to contain illicit methamphetamine. DrugsData.org found that so-called Adderall pills have been found in circulation from Boston, to San Francisco and LA. In September of 2022 the DEA’s New England office seized 660,000 Adderall pills laced with methamphetamine. The LA Times reported on an elaborate counterfeiting operation in Mexico that “repackages meth as Adderall, Vyvanse and other name-brand ADHD medications.” See “Bad Things Could Happen with ADHD and the Adderall Shortage.”

What may have begun as a little help cramming for a test or temporary help with the demands of a challenging job, can lead to habitual use and a reluctance to forego the perceived “edge” from the medication. Adderall and most other ADHD medications are stimulant drugs with the potential for misuse or addiction. They are listed as Schedule II Controlled Substances, with the same addictive potential as many opioids. A 2018 study by Compton et al in the American Journal of Psychiatry found that among US adults, 6.6% used prescription stimulants; 4.5% without misuse and 1.9% misused them. That is, 28.8% of all those prescribed stimulants misused them. Fortunately, only a fraction of the adult population (.2%) met the criteria for a substance use disorder.

Approximately 16.0 million U.S. adults used prescription stimulants in the preceding year (annual average), 5.0 million misused prescription stimulants, and 0.4 million had use disorders. Cognitive enhancement was the most commonly reported reason for misusing prescription stimulants. Patients who are using their medication for cognitive enhancement or diverting their medication to others present a high risk.

Additionally, a study published in JAMA Psychiatry found a small, but statistically significant association between long-term use of ADHD medication and cardiovascular disease (CVD), particularly hypertension and arterial disease. “In this case-control study of 278,027 individuals in Sweden aged 6 to 64 years who had an incident ADHD diagnosis or ADHD medication dispensation, longer cumulative duration of ADHD medication use was associated with an increased risk of CVD, particularly hypertension and arterial disease, compared with nonuse.” The authors concluded that given that long-term exposure to ADHD medications was associated with an increased risk of CVD, “the potential risks and benefits of long-term ADHD medication use should be carefully weighed.” It was suggested for clinicians to monitor cardiovascular signs and symptoms throughout the course of treatment.

The co-authors of an editorial in the same issue of JAMA Psychiatry said concerns about cardiovascular risk associated with ADHD medications are among the most serious issues to consider when discussing the option of starting medication for ADHD. Medscape reported the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded.” Across the 14-year follow up period, each additional year of ADHD medication use was associated with an average 4% increased risk of CVD, “with a larger 8% increased risk in the first 3 years of cumulative use.” The co-authors said this factor should be carefully weighed against the benefits on a case-by-case basis. Given the observational nature of the study, they could not prove causality.

Hartman et al gave an overview of the comorbidity of ADHD in adults with anxiety disorders (AD), major depressive disorder (MDD), bipolar disorder (BP) and substance use disorders (SUDs) in Neuroscience and Biobehavioral Reviews. Their review found that the prevalence rates of ADs, MDD, BD and SUDs in adults were substantially higher when compared to adults without ADHD. These associations were not modified by sex. The authors proposed monitoring sub-threshold symptoms of these disorders in persons with ADHS to facilitate early detection and preventative measures in order to prevent or postpone the full onset of comorbidity. They suggested further research was needed on whether “adequate ADHD treatment can directly decrease the risk of comorbid disorders.”

These concerns and the supply shortage don’t seem to have affected the income generated by ADHD medication very much. PsychCentral reported that three medications for the treatment of ADHD were among the most profitable for their manufacturers in 2020: Concerta (menthyphenidate, $3.28 billion), Vyvanse (lisdexamfetamine, $3.01 billion), and Adderall, (amphetamine/dextroamphetamine, $2.35 billion). Based on the total number of prescriptions purchased, Adderall was 4^th and Concerta was 10^th. Vyvanse did not make the top 25 prescriptions listed, likely because its patent did not expire until August 24, 2023.

Yet, not all psychiatrists agree with the DSM-5’s assessment of what constitutes ADHD, let alone its treatment. Sami Timimi said in his article for the International Journal of Qualitative Studies that it required little intellectual effort to conclude the concept and definition of ADHD is full of problems around reliability and validity. “Deciding where to draw the line between what we consider part of the ‘ordinary’ spectrum of behaviours and what we decide is ‘pathological’ is more dependent on cultural than scientific processes.” He said ADHD was not a medical diagnosis, but a cultural construct that spurred the use of stimulant medication, despite the lack of evidence for improved long-term outcomes.

In Saving Normal, Allen Frances, the chairman of the DSM-IV Task Force and part of the leadership for DSM-III and DSM-III-R warned the DSM-5 will mislabel everyday problems as mental illness and turn normal people into “mental patients.” He said, “The easy path to adult ADHD suggested by DSM-5 will mislabel many normal people who are dissatisfied with their ability to concentrate and get their work done, especially when they feel bored and don’t like the work they’re doing.” Symptoms are mostly subjective and based on self-perceptions of poor concentration and task accomplishment. He thought fake adult ADHD would be particularly common in college students, people with demanding jobs, and those who have to struggle to stay awake, like long haul truckers.

Stimulants are among the most effective and safe of medications in psychiatry when given under appropriate supervision for someone who is accurately diagnosed. But they can cause serious side effects in anyone and are especially harmful when taken by someone with another diagnosis that has been misidentified as ADHD (especially substance use or bipolar disorder). The increasing use of stimulants as performance enhancers or for recreation also creates a large and illegal secondary street market.

Frances thought the criteria for a first-time diagnosis of ADHD in adults should be more, not less rigorous. All the many causes of inattention should be first ruled out, and the existing ones be “a continuation of ADHD symptoms that started in early childhood.” He thought any late onset of inattention was caused by something else, not ADHD. “Let’s keep DSM as a manual of mental disorders and not turn it into a vehicle for performance enhancement.”

So, perhaps the shortage with Adderall and other ADHD medications is not such a bad thing. Except, that is, for the people buying what they think is Adderall on the black market. For more information on Adderall, see “Dispatches from the Adderall Epidemic” and its series of articles like: The History of Adderall, My Party Drug of Choice, and Fake Addies.

09/12/23

Bad Things Could Happen with ADHD and the Adderall Shortage

In case you didn’t know, the U.S. has been in the midst of an Adderall shortage since October of 2022 when the FDA announced a shortage of the immediate release formulation. At the time, the FDA said some manufacturers having intermittent manufacturing delays, while others reported they could not meet the increased demand. The agency said it has posted information on the shortage and a list of current manufacturers that are still available, and will continue monitor supply and assist manufacturers “with anything needed to resolve the shortage.” But the shortage problem was still with us.

Kate Underwood reported in Green Matters that as of June 2023, the FDA’s Drug Shortages still listed Adderall as a current shortage. While manufacturing disruptions are the typical issues leading to drug shortages, other concerns such as increased demand for the drug, and shortages of the active ingredient or supplies can also occur. Additionally, drug manufacturers don’t usually make a single drug. So, increasing the production of a drug in short supply could negatively impact the availability of other drugs made in the same facility.

Writing for Vox, Dylan Scott added another factor to the Adderall shortage—it is a stimulant drug with the potential for misuse or addiction. The DEA lists Adderall and other stimulant-based ADHD medications as Schedule II drugs, meaning they are considered to have the same addictive potential as many opioids. “The fear is that Adderall would follow the same path as opioid painkillers: careless overprescribing would lead to an epidemic of drug addiction — this time, to stimulants.”

One of the active ingredients in Adderall is amphetamine, and therefore the drug is regulated as a controlled substance under federal law. Its potential for abuse has long been recognized, with the cliche example being college students taking the drug to help them study. A 2018 study by federal researchers found that about 5 million Americans misused a prescribed stimulant, of which Adderall is the most common, at least once in the past year; about 400,000 misused stimulant drugs frequently enough to be characterized as having a disorder. (About 2.7 million people in the US report they have an opioid use disorder.)

Medical News Today described the medical uses, side effects and misuse of amphetamines. The opening sentence on the page says, “Amphetamine is a powerful stimulator of the central nervous system. It is used to treat some medical conditions, but is also highly addictive, with a history of abuse.” Amphetamines are used today to treat ADHD. In the past it has been used to treat narcolepsy, but concerns with side effects have led to it being increasingly replaced by modafinil.

Physical side effects can include low or high blood pressure, erectile dysfunction, rapid heart rate, blurred vision, dry mouth, tics, nosebleed, and others. Psychological effects may include apprehension, anxiety, irritability and restlessness, mood swings, insomnia, obsessive behaviors and grandiosity, or an exaggerated sense of one’s own importance. “In rare cases, psychosis may occur.”

When used as a recreational drug it can speed up reaction times, increase muscle strength and reduce fatigue. A methamphetamine called Pervitin was used by Hitler’s forces for these benefits during WW II; see “Repeating Past Mistakes.”

The DEA Drug Fact Sheet said the following about amphetamines:

The effects of amphetamines are similar to cocaine, but their onset is slower and their duration is longer. In contrast to cocaine, which is quickly removed from the brain and is almost completely metabolized, methamphetamine remains in the central nervous system longer, and a larger percentage of the drug remains unchanged in the body, producing prolonged stimulant effects.

Chronic abuse produces a psychosis that resembles schizophrenia and is characterized by paranoia, picking at the skin, preoccupation with one’s own thoughts, and auditory and visual hallucinations. Violent and erratic behavior is frequently seen among chronic users of amphetamines.

In order to mitigate the potential for abuse, the DEA sets production limits for the manufacturers of Adderall and its generic competitors. In 2019 the DEA announced it was permitting more production of Adderall, but we still don’t know exactly how much production has been authorized or what limits have been set for individual companies. “We don’t know which company gets how much.” Some companies say they are short, but the DEA replies they haven’t used all their supply, so there’s back-and-forth finger-pointing going on. Listen to the On Point program, “What’s behind the ADHD drug shortage” to hear more discussion of this issue.

However, there also seems to a problem that stems from the opioid crisis. In 2021 there was a settlement with the three largest drug distributors that “flag and sometimes block” pharmacies’ orders of controlled substances like Adderall when they exceed a certain threshold. Bloomberg reported that pharmacists said it restricts their ability to fill many different types of controlled substances in addition to opioids. The rules force some independent pharmacists to use creative workarounds. “Sometimes, they must send patients on frustrating journeys to find pharmacies that haven’t yet exceeded their caps in order to buy prescribed medicines.”

This was illustrated in an article for STAT, written by a “biopharma supply chain specialist” who can’t find the Adderall she’s prescribed. She said she’s been using Adderall for ten years to help her function. Then in February of 2023, she was unable to fill her prescription at the pharmacy down the street. She finally was able to fill it at the 20^th pharmacy she called, although it meant a 50-minute drive. She recommended several steps to increase the transparency in the supply chain of Adderall. “This will foster efficiency, reliability, and the ability to identify potential risks before they spiral out of control, as has happened now with not just Adderall but other ADHD medications.”

Money making considerations are also involved in the Adderall shortage. Vox reported that after Adderall was approved in 1996, it quickly became the most commonly prescribed treatment for ADHD, although Ritalin and other drugs are still used. PsychCentral listed Adderall as the fourth most prescribed psychiatric medications, with 26.24 million prescriptions in 2020. Other medications prescribed to treat ADHD within the top 25 most prescribed drugs included: Concerta (10^th), Vyvanse (20^th), and Focalin (24^th). Three of the most expensive medications, making the most money for their manufacturers were Concerta ($3.28 billion), Vyvanse ($3.01 billion), and Adderall ($2.35 billion). ADHD prescriptions accounted for over a third of the prescriptions in 2020.

Axios reported some different statistics for both generic and branded Adderall prescriptions, according to IQVIA, a health research firm. Since 2017, IQVIA reported Adderall prescriptions rose from 32.2 million to 41.4 million. This was up more than 10% from 2020. See the following graph taken from the Axios article.

Axios said prescriptions skyrocketed as it became significantly easier to get a diagnosis of ADHD and a prescription for Adderall during the pandemic. A wave of telemedicine startups emerged on TikTok and Instagram, suggesting people should look into ADHD medication if they felt distracted. The Wall Street Journal reported some startups diagnosed people with ADHD and prescribed stimulants after 30-minute video calls — “entirely remotely, and much faster than a typical diagnosis from an in-person psychiatrist.” The trouble with rapid diagnoses is it can be difficult to tell whether the problem is actually ADHD. “Anxiety can present as ADHD, and depression can present as ADHD.”

This spike in diagnoses raises questions about whether ADHD is being over-diagnosed, but that’s really a question that predates the pandemic. See (“The Tip of the ADHD Iceberg” and “National ADHD Epidemic”) for more information. If supply can’t keep up with demand, experts are warning we could have a public health crisis. Even worse, we could face another movement of people from the pharmaceutical market to the illicit drug market, as what happened with opioids. Leo Beletsky, an epidemiologist at Northwestern University said, “Lots of bad things can happen. … Conditions are very much ripe for that to happen here.”

Overdiagnosis of ADHD

In “Twenty-Year Trend in Diagnosed Attention-Deficit/Hyperactivity Disorder”, Xu et al estimated the prevalence of diagnosed ADHD among US children and adolescents from 1997 to 2016. They estimated the prevalence of diagnosed ADHD among US children and adolescents was 10.2% in 2016. There was a consistent upward trend across subgroups by age, sex, race/ethnicity, family income, and geographic regions. “These findings indicate a continuous increase in the prevalence of diagnosed ADHD among US children and adolescents.” They said the common perception that ADHD overdiagnosed in the US was not supported by the scientific evidence. But that is not the end of the matter.

A 2021 study by Kazda et al, “Overdiagnosis of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents” said that questioning the appropriateness of ADHD diagnosis has grown along with the diagnosis rates. They acknowledged that disagreement continues about how much of the increased diagnoses can be attributed to true increases in frequency, improved detection or diagnostic inflation because of misdiagnosis and/or overdiagnosis. They systematically reviewed the research literature to identify and appraise any evidence of overdiagnosis of ADHD in children and adolescents. They found evidence of overdiagnosis and overtreatment of ADHD.

Of the 12,267 potentially relevant studies retrieved, 334 (2.7%) were included. Of the 334 studies, 61 (18.3%) were secondary and 273 (81.7%) were primary research articles. Substantial evidence of a reservoir of ADHD was found in 104 studies, providing a potential for diagnoses to increase (question 1). Evidence that actual ADHD diagnosis had increased was found in 45 studies (question 2). Twenty-five studies showed that these additional cases may be on the milder end of the ADHD spectrum (question 3), and 83 studies showed that pharmacological treatment of ADHD was increasing (question 4). A total of 151 studies reported on outcomes of diagnosis and pharmacological treatment (question 5). However, only 5 studies evaluated the critical issue of benefits and harms among the additional, milder cases. These studies supported a hypothesis of diminishing returns in which the harms may outweigh the benefits for youths with milder symptoms.

They recommended that practitioners, parents and teachers carefully weigh the potential benefits and harms that can go along with ADHD diagnosis and treatment, particularly when individuals with milder symptoms are identified. “For this group, the benefits of diagnosis and treatment may be considerably reduced or outweighed by harms.”

In his review of the study for Mad in America, Peter Simons said “Each [of the 334 included studies] provided data on at least one of the five conditions. They found that all five conditions were supported by the research.” There was also significant evidence of harm after diagnosis, including how a biomedical view of difficulties was associated with disempowerment. He said the researchers warned that diagnosis “can also deflect from other underlying individual, social, or systemic problems.”

Because there is no biological test for ADHD, and the diagnosis is applied subjectively across age, gender, race, and socioeconomic status, there is room for the diagnosis to expand. Additionally, as the diagnostic criteria are loosened, rates of ADHD have increased. The researchers confirmed that a large proportion of the new cases are on the “mild” end of the spectrum. Rates of stimulant treatment for ADHD have also increased, including those with “mild” or “subclinical” ADHD.

In his book, Saving Normal, Allen Frances, a psychiatrist and the former chair for the DSM-IV, said in retrospect, he wishes there had been cautions in the DSM-IV about overdiagnosis and tips to avoid it. He thought they missed the boat. “No one dreamed that drug company advertising would explode three years after the publication of the DSM-IV or that there would be the huge epidemics of ADHD, autism, and bipolar disorder—and therefore no one felt any urgency to prevent them.” For more on the DSM and overdiagnosis, see “Guild Interests Behind DSM Diagnosis.”

The Demedicalization of ADHD

Not only does it seem ADHD is overdiagnosed, there are some researchers who question whether the diagnosis of ADHD meets the criteria for a disorder set out in the manual used by the medical and psychiatric fields. Freedman and Honkasilta argued that the definition of ADHD relies on subjective cultural values to define “abnormal” behavior. Reviewing their study for Mad in America, Peter Simons said, “The diagnosis thus fails to meet the criteria, as stated in the DSM, that disorders must not be reducible to behavior that violates social norms.” The researchers argued that ADHD should be demedicalized and removed from the DSM, like homosexuality was in 1980.

The British Child and Adolescent Psychiatrist Sami Timimi said in his 2017 article, “Non-diagnostic based approaches to helping children who could be labeled ADHD and their families” that it required little intellectual effort to conclude that the concept and definition of ADHD “is replete with problems around reliability and validity.” The diagnostic guidelines note how ADHD behaviors may be minimal or absent in several settings. These include when the person in under close supervision, engaged in an activity that is particularly interesting to them or in a new, novel setting. Even if a genetic basis for ADHD were found, we’d still have to ask why such behaviors should be treated as disorder rather than differences. “Deciding where to draw the line between what we consider part of the “ordinary” spectrum of behaviours and what we decide is “pathological” is more dependent on cultural than scientific processes.”

He said if he asked the question, “what is ADHD?”, it is not possible for him to reply by referring to a particular known pathological abnormality. Instead, he would have to provide a description ADHD as the presence behaviors like of hyperactivity, impulsivity and poor attention. This was contrasted with answering the question, “what is diabetes?” “Diagnosis in that context sits in a “technical” explanatory framework. In psychiatry what we are calling diagnosis (such as ADHD) will only describe but is unable to explain.”

Timimi concluded that ADHD is then not a medical diagnosis, but rather a descriptive classification. And since it is not a medical diagnosis, “it is not surprising that there has been a failure to find any specific and/or characteristic biological abnormality such as characteristic neuroanatomical, genetic or neurotransmitter abnormalities.” He thought the idea of ADHD as a medical diagnosis was past its use-by date and should be discarded.

ADHD is a cultural construct. It is often argued that the use of categorical constructs like ADHD enables the study of aetiology, treatment and prognosis. Evidence outlined above demonstrates that far from enabling any advancement of knowledge or clinical practice, it has created an illusion of progress and resulted in exposure of possibly millions of children and young people to unnecessary and potentially harmful medications. It has spurred on liberal use of stimulant medication, despite the lack of evidence for improved long term outcomes resulting from this.

We are not at the cultural crossroads with ADHD today that we were with homosexuality in 1980. ADHD will likely continue to be a diagnosable disorder. Yet serious consideration of the above discussion of its overdiagnosis, its future demedicalization and removal from the DSM as a disorder and the lack of improvement in long-term outcomes of individuals taking ADHD prescribed stimulants should be done. In retrospect, the Adderall shortage may not truly be the serious public health crisis that is getting all the press coverage. But if it leads people from the pharmaceutical market to the illicit drug market in search of their amphetamines to help them function, like the person in the STAT article, “Lots of bad things can happen.”

03/9/21

Weighing the Risks with ADHD Medication

Did you know that millions of children in the US have been diagnosed with ADHD? The CDC said in “Data and Statistics About ADHD,” that the number of US children diagnosed with ADHD increased from 4.4 million in 2003 to 6.4 million in 2011. It decreased to 6.1 million in 2016. Sixty-two percent of the children diagnosed with ADHD are taking medication. And yet, the prominent Harvard psychologist Jerome Kagan believes ADHD is an invention.

Kagan made this claim in a 2012 interview with Spiegel, when he was asked if he was saying ADHD was just an invention, he said: “That’s correct; it is an invention.” Every child who does not do well in school is sent to a pediatrician who then says: “It’s ADHD; here’s Ritalin.” The neurologist Steven Novella said in “The ADHD Controversy,” that such a characterization was irresponsible. He acknowledged the fact that ADHD is a fuzzy clinical entity, but said progress has been made in understanding what is happening in the brains of most people with ADHD.

The current consensus is that ADHD is a deficit of executive functions. The frontal lobes carry out many critical functions, some considered executive functions: they include being able to focus your attention, maintain focus, switch among tasks, filter out distractions, and impulse control. Executive function includes the ability to weigh the probable outcomes of your behavior and then make high-level decisions about how you will behave.

He went on to say that convergent data from neuroimaging, neuropsychology, genetics and neurochemical studies point to the involvement of a part of the brain known as the frontostriatal network contributing to the pathophysiology of ADHD. “At this point there is no reasonable disagreement about the fact that ADHD is a disorder of brain function.” He referred to an article by David Tuller, whose concerns were more nuanced than Kagan’s. Tuller interviewed Richard Scheffler, co- author of The ADHD Explosion with Stephen Hinshaw. He said the issue was a spike in ADHD diagnoses, not that ADHD was an invented disease.

ADHD is real—it’s not made up. But it exists on a continuum. There’s no marker or white line that says you’re in the “definite” or “highly likely” group. There’s almost unanimous agreement that five or six percent clearly have enough of these symptoms for an ADHD diagnosis. Then there’s the next group, where the diagnosis is more of a judgment call, and for these kids, behavioral therapy might work. And then there’s a third group, on the borderline. These are the ones we’re worried about being pushed into an inaccurate diagnosis.

Scheffler said the research done for their book found that in general, there was a relationship between the rates of ADHD diagnoses and changes in the 1990s with how many states budgeted schools. Money was provided based upon the number of students making positive movement towards performance measures like graduation rates and test scores. Then in the early 2000s, President Bush tied federal dollars to the same kind of budgeting for performance. “We were able to show that these moves were highly correlated with spikes in various states in the diagnosis of ADHD.”

In an opinion article for The New York Times, Hinshaw and Scheffler said that unless we were careful, we faced an epidemic of 4- and 5-year-olds being wrongfully told they have ADHD. Their research showed skyrocketing ADHD diagnoses, especially among the nation’s poorest children. Their research data seems to reflect that reported above in the first paragraph by the CDC in “Data and Statistics About ADHD.”

For example, we found that in public schools, A.D.H.D. diagnoses of kids within 200 percent of the federal poverty level jumped 59 percent after accountability legislation passed, compared with under 10 percent for middle- and high-income children. There was no such trend in private schools, which are not subject to legislation like this.

By the age of 17, nearly one in five American boys and one in ten girls will be told they have ADHD. This is a 40 percent increase over the last ten years and double the rate of 25 years ago. They see this leading to more prescriptions despite the guidance from organizations like the American Academy of Pediatrics that behavioral therapy, not medication, should be the first-line treatment for children under 6. Accurate diagnosis requires reports of impairment from home and school, and a thorough child and family history to rule out abuse or unrelated disorders. “Too many kids are identified and treated after an initial pediatric visit of 20 minutes or even less.”

The CDC data indicated 77% of the children diagnosed with ADHD between the ages of 2 and 17 were receiving treatment. Thirty percent were treated with medication alone; 15% received behavioral treatment alone; and 32% received both. Around 23% were receiving neither medication nor behavioral treatment. approximately 5 in 10 children with ADHD also had a behavior or conduct problem; 3 in 10 with ADHD had anxiety. Seventeen percent were said to be depressed and 14% had autism spectrum disorder.

So there seems to be a problem with accurate diagnosis and overdiagnosis of ADHD leading to medication treatment. What are the implications of these diagnostic problems? And what are the long-term consequences for the children who are medicated?

A Norwegian article, “Drug Treatment of ADHD—tenuous scientific basis,” said that recent systematic reviews indicated there was a weak evidence base for the use of methylphenidate (Ritalin, Concerta) when treating children and adolescents with an ADHD diagnosis. The authors began with an examination of the MTA study (Multimodal Treatment Study of ADHD), stating it was crucial to understanding the current state of knowledge on ADHD treatment. The MTA study showed a reduction in ADHD symptoms in the medication groups at 14 months. But that significance disappeared over the next two years.

After six years, participants in the MTA study who received behavioral therapy but no medication had lower rates of anxiety and depression. The latest results were published in 2017, 16 years after the start of the study. After evaluating the data, the conclusion of the researchers was that the long-term use of central nervous system stimulants was associated with a suppression of adult height, on the average of 1-2 cm. But there was no reduction in ADHD symptoms.

There is no doubt that children with ADHD have genuine and serious problems. However, we cannot ignore the fact that research has yielded only weak evidence to support the extensive use of medication that occurs today. This state of affairs should trigger renewed public and expert discussion on the pharmacological treatment of ADHD in children and adolescents.

There was a further investigation of participants in the MTA study, this time of adolescents and young adults without childhood ADHD: “Late-Onset ADHD Reconsidered.” The purpose of the study was to investigate an influx of adolescents and young adults who present at clinics with complaints of inattention and/or hyperactivity/impulsivity complaints and inquire about stimulant medication. “It remains unclear whether this trend is driven by typically developing individuals seeking stimulant medication for cognitive enhancement or by individuals with late-onset ADHD that warrants medical treatment.” The results indicated that when assessing adolescents and young adults for first-time ADHD diagnoses, clinicians should obtain a thorough psychiatric history and assessment of current functioning.

After using a diagnostic procedure that considered multi-informant data, longitudinal symptoms patterns from childhood to adulthood, Co-occurring mental disorders and substance use, 95% of the individuals who originally screened positive for late-onset ADHD were excluded from diagnosis. When assessing adolescents and young adults for first-time ADHD, 53% of adolescents and 83% of adults who met all the late-onset criteria for ADHD were excluded because their symptoms “were better explained by heavy substance use or another mental disorder.”

SAMHSA, the Substance Abuse and Mental Health Services Administration, noted in “Adults with Attention Deficit Hyperactivity Disorder and Substance Use Disorders” studies that have found adults with ADHD are more likely than their peers without ADHD to develop a substance use disorder (SUD) sometime in their lives. One large epidemiological study found that 15.2% of adults with ADHD also met the criteria for an SUD, compared to 5.6% of adults without ADHD. Research has also indicated that as the severity of ADHD increases, so may the SUD risk. “In a recent analysis of data from the National Epidemiologic Survey on Alcohol and Related Conditions, each additional ADHD symptom before age 18 was associated with a greater lifetime chance of developing substance dependence.”

Much of the research into the misuse of prescribed stimulants has been with college students. College students were found to misuse Dexedrine and Adderall more than other prescribed stimulants. According to the 2012 National Survey on Drug Use and Health, the nonmedical use of Dexedrine and Adderall has risen among college-aged adults and adults 26 and older. Between 4 and 20 percent of college students have used a prescription stimulant without having a legitimate prescription in the past year, typically obtaining the medication from friends who either sell or give their medications away. “Roughly a third of college students with ADHD report that they have sold or given away their medication at least once.” See the following chart.

So, what are the risks with ADHD medications? There are problems with diagnosis and concerns of overdiagnosis, particularly with poor children (See “Demolishing ADHD Diagnosis”). After 2 or 3 years the positive effects of ADHD medications seem to disappear. Long-term use seems related to a suppression of adult height. There appears to be an association between ADHD and an increased risk of SUD. At least one study concluded there is weak evidence for the use of Ritalin and Concerta when treating children and adolescents with an ADHD diagnosis. ADHD was said to be a “fuzzy clinical entity” by a neurologist who believes ADHD is a disorder of brain function.

Web MD said the side effects and risks from long-term use of ADHD medication include: heart disease, high blood pressure, seizure, irregular heartbeat, abuse and addiction, and skin discolorations. Although it’s rare, ADHD medications may be tied to mental health issues like aggression and hostility; and some say they developed symptoms of bipolar disorder. “The FDA has also warned that there’s a slight risk that stimulant ADHD drugs could lead to mood swings or symptoms of psychosis—like hearing things and paranoia.”

05/28/19

The ADHD Fairy

In case you didn’t know, there is a risk of psychosis when using ADHD stimulant medications, such as amphetamine (Adderall, Vyvanse) and methylphenidate (Ritalin, Concerta). A study published recently in The New England Medical Journal indicated the risk was low, with about 1 in 660 patients who used prescription stimulants diagnosed with new-onset psychosis. The lead author of the study, Dr. Lauren Moran, said the risk was low enough that she could not recommend not prescribing Adderall. “But from a public health perspective, there’s so many millions of people being prescribed these medications that it actually leads to thousands of people at increased risk of psychosis.” Using data from the CDC on ADHD, that meant in 2016 about 5,730 children between the ages of 2 and 17 who were taking ADHD stimulants would be diagnosed with new-onset psychosis.

Medscape reported Dr. Moran said the takeaway point was “that it’s really important to screen for potential risk factors.” These risk factors could include a history of bipolar or other psychiatric disorder, a family history of psychiatric illness, or use of cannabis (See: “Gambling with Cannabis and Psychosis”). “If patients have those risk factors, I would shy away from using the amphetamines. You don’t want to have two things that could potentially further increase the risk for psychosis.”

Moran noted that there are many college students in the area around McLean Hospital and that in her anecdotal experience as a psychiatrist working in a unit that treats patients with psychotic disorders, she’s “been seeing cases of young individuals coming in with psychosis” after stimulant use.

Moran said at the beginning of their study, a patient had a 50-50 chance of getting Adderall or Ritalin. But there has been a dramatic increase in Adderall prescriptions, to almost four times as many prescriptions for Adderall. In her experience, ADHD patients hospitalized for psychosis recovered in two weeks; some took as long as two months. But Moran is not suggesting ADHD medications are too dangerous to prescribe. Rather, she’s trying to raise awareness. “Physicians need to be aware of this when prescribing and people who are getting these medications from friends in college need to know this is a risk.”

Speaking to STAT News, Dr. Anthony Rostain said he did not think the results of the Moran et al. study was shocking. The package insert already warns of a small risk of psychosis with ADHD stimulant medication. “It will just simply be important to mention to people that the amphetamine-based compounds have a slightly higher risk… I think the take-home here should be that everyone should be informed when they are starting a medicine about risks like psychosis.” One of the risk factors he gave for psychosis was abusing the drugs—crushing and snorting them. So the implication is that the individuals at risk are those who abuse this medication, which is admittedly an issue on college campuses.

But is that the real problem, namely that the people at risk are those who are abusing ADHD stimulants? First let’s consider the industry ties of the two doctors cited here. Rostain has been a consultant to Arbor Pharmaceuticals, an amphetamine maker, and to Shire, which sells Vyvanse and developed Adderall; Dr. Moran reported only receiving a grant from the NIMH to investigate the risk of psychosis with prescription stimulants. Is Rostain contributing to some misdirection of the issue because of his industry ties?

Did you know that so-called “challenge studies,” where amphetamine and methylphenidate were used to instigate symptoms of psychosis, were done in the name of science? Robert Whitaker co-wrote a series of articles that described how beginning in 1972, psychiatric researchers used amphetamine, methylphenidate and ketamine “to deliberately provoke psychotic symptoms in more than 1,200 schizophrenic patients.” In some cases, the level of psychosis experienced by these patients was called “severe.” Some of these experiments were conducted by prominent researchers at the National Institute of Mental Health. David Janowsky’s work established the idea that psychosis-inducing drugs “could be used as ‘challenge agents’ to turn patients into models for studying psychotic illnesses.”

Symptom-exacerbation experiments were pioneered by Dr. David Janowsky of Vanderbilt University. In 1974, he reported success in developing a new tool for studying schizophrenia. He found that giving schizophrenic patients methylphenidate (Ritalin) caused ”a dramatic intensification of preexisting symptoms, such as hallucinations and delusions,” and that amphetamine also exacerbated their psychosis. Both drugs are known to release dopamine, a messenger chemical in the brain, and Janowsky’s experiments provided indirect evidence that the biological mechanism of psychosis involved an overactive dopamine system.

Dr. Jeffrey Lieberman, currently the department chair of psychiatry at Columbia, did several challenge studies with methylphenidate. In a 1987 study, 34 stable outpatients receiving antipsychotics were given methylphenidate and then withdrawn from their antipsychotics. Three weeks later, they were given another infusion of methylphenidate. They were then followed up for 52 weeks or until they relapsed—in other words until their symptoms returned.

In a 1990 study, 38 patients who met the criteria for schizophrenia or schizoaffective disorder were given methylphenidate. These were patients experiencing their first acute psychosis. The methylphenidate produced an increased psychopathology seen in the worsening of their symptoms. And in a 1987 article, Lieberman and his coauthors commented that methylphenidate appeared to have a greater “psychotogenic potency” than amphetamine. They hypothesized there was a subgroup of schizophrenic patients who exhibited psychotic activation with psychostimulants. “This biologic phenomenon may be clinically exploitable and should be investigated further.” Also see “Psychiatry, Diagnose Thyself! Part 2” for more information on challenge studies.

MacKenzie et al. found an association between the use of stimulant medication and psychotic symptoms in children and adolescents at risk of mental illness. Psychotic symptoms were found in 62.5% of the participants who had taken stimulants versus 27.4% of participants who had not taken stimulants. All participants who had used stimulants and experienced psychotic symptoms were sons or daughters of a parent with either a major depressive disorder or bipolar disorder. “The association of current use of stimulants with current psychotic symptoms and the close temporal relationship between stimulant use and psychotic symptoms in youth who started and stopped stimulants indicated a potential causal relationship.” See “Tip of the ADHD Iceberg” for more information.

ADHD stimulants are addictive. Ritalin and Adderall are Schedule II controlled substances, meaning they are considered to have a high potential for abuse, with their use “potentially leading to severe psychological or physical dependence.” Methamphetamine adverse effects can include convulsions, memory loss, severe dental problems and even death. “Cocaine and potent stimulant pharmaceuticals, such as amphetamines and methylphenidate, produce similar effects.” The effects of amphetamines are similar to cocaine but occur slower and last longer.

Chronic abuse produces a psychosis that resembles schizophrenia and is characterized by paranoia, picking at the skin, preoccupation with one’s own thoughts, and auditory and visual hallucinations. Violent and erratic behavior is frequently seen among chronic users of amphetamines and methamphetamine.

A 2015 study by Clemow and Walker reviewed the literature on ADHD medication misuse. The authors found that elevations in brain dopamine levels seemed to be necessary to both their efficacy in ADHD and in their potential for abuse. The data suggested ADHD medication misuse was a common health care problem for stimulant medications, “with the prevalence believed to be approximately 5% to 10% of high school students and 5% to 35% of college students, depending on the study.” Conversely, nonstimulant ADHD medications did not suggest a potential for abuse. “In light of these findings, the data suggest a need for close screening and therapeutic monitoring of ADHD medication us.”

And if that is not enough to raise concerns with the use of amphetamine and methylphenidate to treat ADHD, there is evidence that challenges their long-term effectiveness. The National Institute of Mental Health (NIMH) funded a nationwide, long-term study of the effectiveness of stimulants in treating ADHD by many of the long-time advocates of stimulant medication. In 2007 the authors finally published their evaluation of long-term effectiveness. The Jensen et al. study concluded: “By 36 months, the earlier advantage of having had 14 months of the medication algorithm was no longer apparent.” The Swanson et al. study said: “All five propensity subgroups showed initial advantage of medication that disappeared by the 36-month assessment.”

So where does this leave us with regard to ADHD? Is it even a valid diagnosis? In Debunking ADHD, Michael Corrigan said ADHD diagnosis in its current form is a diagnosis of normal, using eighteen very generic, commonly observed childhood behaviors to justify giving the medications. “Coincidentally or conveniently, ordained by the all-knowing creators of ADHD as proof of ADHD’s existence, these eighteen childish behaviors … seem to drive parents and educators crazy.” ADHD is a negative label that some want you to believe is real. Like the stories of about unicorns, fairies and leprechauns, “the diagnosis of ADHD is a brilliant work of fiction.” In Our Post Human Future, Francis Fukuyama also suggested ADHD wasn’t a disease, but rather, “just the tail end of the bell curve describing the distribution of perfectly normal behavior.”

Young human beings, and particularly young boys, were not designed by evolution to sit around a desk for hours at a time paying attention to a teacher, but rather to run and play and do other physically active things. The fact that we increasingly demand that they sit still in classrooms, or that parents and teachers have less time to spend with them on interesting tasks, is what creates the impression that there is a growing disease.

For more information on ADHD, see: “ADHD: An Imbalance of Fire over Water or a Case of the Fidgets?”

09/26/17

Demolishing ADHD Diagnosis

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?”

06/21/16

Now There’s Chewable Speed

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.”

05/21/14

Is ADHD Simply a Case of the Fidgets?

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

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

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

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

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

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

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

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: ADHD medications