User blogs

Tag search results for: "adhd"

Two years ago, we investigated the suicide of a 7-year-old Florida foster child five years after his death, to find out whether officially recommended changes to the state's foster care program had been implemented following the tragedy. Based on records obtained from the Department of Children and Families (DCF) spanning the five-year period after the child's suicide, we concluded nothing had changed. After reviewing the DCF records, psychiatrist and child advocate Dr. Peter Breggin warned then about the foster program's ongoing and dangerous practice of psychotropic polypharmacy: “Whenever you put children on multiple psychiatric drugs you are creating an experiment that is doomed to do more harm than good... We need to stop experimenting on America's children.”


We had hoped by calling attention to the lack of real progress overhauling the Florida foster care program's over-reliance on pills to cure all ills, further tragedies might be prevented. Mission failed.


Recently, a 14-year-old Florida foster child, prescribed a psychotropic cocktail similar to the 7-year-old foster child, committed suicide in a nearly identical manner, only this time streamed live on Facebook.


In 2009, 7-year-old Gabriel Myers hanged himself in the bathroom of his Florida foster home. Toxicology detected amphetamine, fluoxetine and olanzapine in his system. Medical records indicated psychiatrist Dr. Sohail Punjwani prescribed young Gabriel 50mg of the ADHD drug Vyvanse (lisdexamfetamine dimesylate), and 25mg of the antidepressant and antipsychotic combination drug Symbyax (fluoxetine, olanzapine). Although there was was no doubt Gabriel died at his own hand, Broward Deputy Chief Medical Examiner Dr. Stephen Cina did not rule his death a suicide, stating: “It is unclear whether these drugs contributed to this fatality or not.” Dr. Cina noted in his report that neither Symbyax, nor one of its key ingredients olanzapine, also known by the brand name Zyprexa, was approved for use in children; and that “fluoxetine [Prozac] and olanzapine can increase the risk of suicidal ideation in children taking this drug.”


It also came to light that Gabriel was among Florida foster children being used as guinea pigs for pharmaceutical clinical trials. After an investigation into his clinical trial practices, the Food and Drug Administration (FDA) issued a warning letter to Dr. Punjwani, citing violations including failure to protect the rights, safety and welfare of human test subjects; doses exceeding protocol-specified limits; and failure to follow clinical trial plans. Through an executive order, then DCF Secretary George Sheldon instituted a limited prohibition of the shady practice of conducting drug experiments on Florida's foster children.


A recent Canadian study found youth prescribed ADHD drugs were thirteen times more likely to be prescribed antipsychotic medications, and almost four times more likely to be prescribed antidepressant medications than children who were not prescribed ADHD drugs. The study's authors argued that children with ADHD have more psychiatric comordibities than children without ADHD, omitting the exceedingly relevant fact that psychosis and depression are labeled side effects of ADHD drugs. Clearly, the possibility eluded the authors that the increased rates of psychosis and depression observed may not be linked at all to so-called comorbidities of ADHD, but rather to the drugs prescribed to treat ADHD.


Indeed, the Vyvanse label warns: “Vyvanse at recommended doses may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania.” According to the DSM-5, up to twenty-five percent of all first episodes of psychosis are substance/medication-induced. Likewise, the label for the stimulant drug also warns: “Fatigue and depression usually follow the central nervous system stimulation.”


Research suggests drug treatment of ADHD unleashes a domino effect, triggering more psychiatric diagnoses, which in turn lead to risky polypharmacy. The cascading reactions associated with drug treatment of ADHD are especially disturbing, considering many children have been misdiagnosed with ADHD in the first place.


Which leads us to the tragic case of Naika Venant, the 14-year-old Florida foster child who recently hanged herself in the bathroom of her Florida foster home, witnessed in real-time on Facebook Live. Medical records from a medication management visit the month prior to her suicide indicate psychiatrist Dr. Scott Segal increased Naika's doses of Vyvanse and Zoloft (sertraline) to 50mg each.


Like Gabriel, Naika was prescribed 50mg of Vyvanse. Like Gabriel, Naika was also prescribed an antidepressant. Like Gabriel, Naika also hanged herself in the bathroom of a Florida foster home. Almost inconceivably, the medical offices where Gabriel and Naika were treated have the same street address, too. Which leads to an obvious question: Was Naika involved at some point in a clinical drug trial, like Gabriel?


Centers for Medicare and Medicaid Services (CMS) records indicate Shire, the manufacturer of Vyvanse, paid the Segal Institute for Clinical Research over three hundred seventy thousand dollars from 2013 to 2015. In response to a complaint alleging Dr. Segal enrolled a subject with a diagnosis of bipolar disorder in a schizophrenia study, the FDA previously inspected the site, initially classifying the inspection in the field as requiring voluntary corrective action, a classification subsequently amended at headquarters based on evidence of a dual diagnosis later supplied by Dr. Segal.


Even so, the DCF incident report in response to Naika's suicide does not reflect as favorably on the doctor(s) who prescribed her drugs for ADHD and depression, going so far as to question whether she even had ADHD in the first place, and noting the cascading effect of such a diagnosis:


Lastly, there was a noted concern regarding possible inaccurate and multiple diagnoses. Naika’s primary diagnosis consistently remained Attention Deficit Hyperactivity Disorder (ADHD). An ADHD diagnosis for a child who has suffered trauma, however, comes with its challenges, including how often symptoms of trauma in young children mimic those with ADHD. A psychological evaluation conducted with Naika stated that there is much concern that her attention problems are due to anxiety and trauma rather than ADHD symptomatology and recommended further evaluation to clarify the ADHD diagnosis. However, it does not appear that further evaluation was conducted. In addition to the ADHD diagnosis, Major Depression, Post Traumatic Stress Disorder and Disruptive Mood Dysregulation Disorder were given by various treating mental health professionals over the course of Naika’s life. However, limited documentation within the assessments does not appear to support these diagnoses or the medication prescribed [emphasis added]. An additional consideration is the cascading effect of a diagnosis, which drives the development of the treatment plan.


With respect to other suicides noted in its recent Vyvanse pediatric safety review, the FDA seemed to trivialize fatal adverse event reports associated with the drug, chalking them up to comorbidities and teen angst: “It is difficult to perform a causality assessment of suicide-related events and lisdexamfetamine from the postmarketing cases, because of the comorbid conditions... and the prevalence of youth suicides.” Readers familiar with our research published on Mad in America will recognize this FDA Vyvanse pediatric review as the same document the agency retroactively redacted to cover up the homicide of an infant by a child prescribed the stimulant – a day after Shire submitted a New Drug Application (NDA) for a chewable formulation of the drug intended for young children. Nothing to see here, move along.


Children are our most precious resource, and foster kids are among the most vulnerable of them to whom our society owes a special duty of care. As Dr. Breggin pointed out: “These children need to be treasured and protected, and to be given wrap-around loving care. They do not need psychiatric drug interventions, which inflict more neglect and abuse by suppressing their mental functions in order to make them more manageable.”


If the FDA will not fulfill its mandate to seriously investigate pediatric psychotropic fatalities and adequately warn the public of elevated polypharmacy risks, then it's up to us as parents to spread the word ourselves.

Big Pharma about to feel the "Bieber" effect. In GQ article, Justin Bieber details how his doctor first prescribed him Adderall‬ off-label for lack of sleep, then told him to quit the ADHD‬ stimulant drug because it was causing him anxiety. Singer says feels "fine" now off Adderall, taking "natural" aids. You can bet Pharma Execs texting, emailing each other in a panic wondering what to do. Millions of Beliebers‬ to follow singer's lead and ditch their anxiety-inducing amphetamines?


http://www.gq.com/story/justin-bieber-gq-interview

Response to Charles Krauthammer's Op-Ed Another massacre, another charade suggesting that psychosis, not guns, is the real cause of mass shootings in America.


On the one hand, Mr. Krauthammer suggests that more aggressive psychiatric intervention might make a difference; and on the other he states that Roseburg shooter Christopher Harper-Mercer "had no psychiatric diagnosis beyond Asperger's."

First, apparently Mr. Krauthammer missed the memo that Asperger's is no longer a psychiatric diagnosis - it was voted out of the latest version of the American Psychiatric Association (APA) Diagnostic and Statistical Manual (DSM-5), published in May 2013.  Many people don't realize that so-called mental disorders are voted in or voted out of American psychiatry's "bible," not scientifically discovered or undiscovered.  Another prominent example of a so-called mental disorder going the way of the dodo by popular vote of American psychiatrists is homosexuality, first included in, then excluded from the DSM.  Referring to the DSM-5, Dr. Thomas Insel, Director of the National Institute of Mental Health (NIMH), declared,"The weakness is its lack of validity.  Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure... Patients with mental disorders deserve better... That is why NIMH will be re-orienting its research away from DSM categories." ( http://www.nimh.nih.gov/about/director/2013/transforming-diagnosis.shtml

American psychiatry's inability to determine with scientific clarity what does or does not constitute a mental disorder is compounded by the fact that the United States is one of only two countries in the world, New Zealand being the other, that allows direct-to-consumer advertising by pharmaceutical companies.  Big Pharma does such a good job of disease-mongering -- often inventing then selling a disorder and creating then funding corresponding "grassroots" advocacy groups (aka "astroturfing") in order to sell their drugs -- that it makes it difficult to take back a mental disorder once it has been invented and sold to the American public. 

The first and most obvious flaw with the wishful thinking that more aggressive psychiatric intervention might make a difference (read prevent) mass shootings in America is that American psychiatry cannot reliably define what a mental disorder is, let alone agree upon and recommend its efficacious treatment.

Second, Mr. Krauthammer can't possibly know for a fact that Mr. Harper-Mercer's only psychiatric diagnosis was Asperger's.  This is a classic example of jumping to conclusions, based on a report of out-of-context online posts by a relative.  It has also been reported that Mr. Harper-Mercer's online alias was "Lithium_love."  It should be noted that if in fact Mr. Harper-Mercer was taking lithium, that drug is indicated for Bipolar Disorder, not Asperger's (or Autism Spectrum Disorder/ASD).  So if Mr. Harper-Mercer was prescribed lithium, he was either diagnosed with Bipolar, or the drug was prescribed to him off-label.  To be sure, off-label prescribing, as well as polypharmacy (ie. prescribing multiple drugs), is rampant in American psychopharmacology, a symptom of the shoot first aim later, trial and error prescribing habits of an industry that has a tough time defining mental illness, much less deciding on how to effectively treat it.  The reality is we will probably never know the extent of Mr. Harper-Mercer's psychiatric diagnoses, or the name, number and doses of the psychotropic medications prescribed to treat them.

Third, Mr. Krauthammer invoked the Naval Shipyard shooter Aaron Alexis as an example of someone whom he suggests did not receive needed psychiatric help.  In fact, Mr. Alexis received psychiatric care from the Department of Veterans Affairs, in the form of a prescription for the antidepressant drug Trazodone ( https://www.washingtonpost.com/national/health-science/trazodone-antidepressant-used-by-aaron-alexis-described-as-very-safe/2013/09/18/4336c044-20ae-11e3-966c-9c4293c47ebe_story.html ).  Mr. Alexis went voluntarily to the VA for help with a psychiatric symptom, and pills are what he was given.  This is where we get to the root of the problem, as well as expose one of the biggest myths about mass shooters.

The fact of the matter is that most mass shooters in recent history were under psychiatric care and were prescribed psychotropic medications: e.g. Joseph Wesbecker (Prozac, lithium, trazodone, temazepam), Eric Harris (Luvox), Edward Lutes (Luvox), Jeffrey Weise (Prozac), Steven Kazmierczak (Prozac, Xanax, Ambien), Robert Stewart (Celexa, Xanax), Kipland Kinkel (Prozac, Ritalin), Aaron Alexis (Trazodone), James Holmes (Zoloft, Klonopin), Ivan Lopez-Lopez (Celexa, Wellbutrin, Ambien, Lunesta), Aaron Ybarra (Prozac, Risperdal), Bradley Stone (Risperdal, Trazodone), Elliot Rodger (Xanax), Myron May (Vyvanse, Wellbutrin, Seroquel), etc.

The suggestion that the aforementioned mass shooters were not receiving psychiatric care, and if only they had access to needed psychiatric care then perhaps the tragedies might have been averted, is misleading.  The problem is that in America -- where doctors are paid handsome consulting fees by pharmaceutical companies to pitch their drugs to other doctors, and where the pharmaceutical industry spends approximately $230M per year to influence Congress --  psychiatric care has become synonymous with psychotropic drugging. 

The earlier choice of the words "in recent history" was not accidental, because this tragic mass shooting phenomenon has only been recent in America's history, since the clock tower shooter Charles Whitman (Valium, Dexedrine) killed 16 people on the University of Texas campus.  In an upcoming documentary, Dr. Jean Stolzer points out that "guns have always been in this country since the first Europeans stepped on American shores." (see also https://leoniefennell.files.wordpress.com/2013/05/the-systemic-correlation-between-psychiatric-medications-and-unprovoked-mass-murder-in-america2.pdf )  Likewise, President Obama has pointed out: "The United States does not have a monopoly on crazy people.  It's not the only country that has psychosis.  And yet we kill each other in these mass shootings at rates that are exponentially higher than any place else.  Well, what's the difference?" [NOTE: Most people missed the fact that Mr. Obama's above response was to a question about mass shootings posed via Tumblr by Nick Dineen, residential assistant to UC Santa Barbara mass killing victim George Chen - whom the coroner later determined was killed with a knife, not a gun, like two other of Elliot Rodger's victims.  Mr. Obama's response and Mr. Dineen's question can be viewed here: https://www.youtube.com/watch?v=NDVFs2l6-fo and the coroner's findings that Mr. Chen, Weihan Wang, and Chen Hong each died of multiple stab wounds can be viewed here: http://www.sbsheriff.us/documents/ISLAVISTAINVESTIGATIVESUMMARY.pdf .  This demonstrates how jumping to conclusions based on initial media reports can be problematic.]

Indeed, what's the difference?  Neither guns or psychosis are new or unique to America.  So what has changed? 

What has changed in America and what is unique to our country is the alarming increase in the number of Americans taking psychotropic drugs, which carry FDA-mandated label warnings of serious psychiatric adverse events, including suicidal and homicidal ideation.

For example, a recent study commissioned by the Louisiana Senate ( http://dhh.louisiana.gov/assets/ADHD/ADHD_DHH_RspnseRsltn39.pdf ) found that 35.8 percent of ten-year-old white boys were diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and prescribed predominantly stimulant medications, which an FDA Center for Drug Evaluation and Research (CDER) medical reviewer found cause hallucinations, mania, and psychosis at a rate of two to five per hundred person years ( see http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.pdf and http://www.fda.gov/ohrms/dockets/ac/06/minutes/2006-4210m_Minutes%20PAC%20March%2022%202006.pdf ).  The FDA's medical reviewer also noted that the psychotic side effects of ADHD stimulants occur in regular doses, in children with no risk indicators or other psychiatric history besides ADHD, and at a rate that cannot be considered rare.

Whereas in some places in our country nearly two out of every five ten-year-old boys are being medicated with psychosis-inducing drugs for ADHD, the estimated rate of ADHD diagnosis in Europe is less than one percent ( https://www.psychologytoday.com/blog/suffer-the-children/201203/why-french-kids-dont-have-adhd ).  Over-diagnosis and over-medication of psychiatric disorders is a decidedly American problem.

Similarly, while Britain was banning antidepressants for kids due to an increased risk of suicidal thoughts and behavior associated with the drugs, the FDA threatened the same medical reviewer, Dr. Andrew Mosholder, with an internal investigation, and prevented him from presenting his findings that the drugs doubled suicidality in kids at a Pediatric Advisory Committee meeting ( http://www.gpo.gov/fdsys/pkg/CHRG-108hhrg96099/html/CHRG-108hhrg96099.htm ).

According to the DSM-5,"Between 7 percent and 25 percent of individuals presenting with a first episode of psychosis in different settings are reported to have substance/medication-induced psychotic disorder."

Big Pharma invented and has successfully marketed the unproven theory that mental illness is the result of a chemical imbalance in the brain.  Swallowing this marketing theory hook, line and sinker, Americans are also swallowing psychotropic pills -- and shoveling them into their children's mouths -- at rates dwarfing other nations. 

Ironically, there is evidence that psychotropic drugs derive their action precisely by creating a chemical imbalance in the brain, according to former NIMH Director Dr. Steven Hyman ( http://search.proquest.com/openview/5610c361a22516dda3dc72bb25f5371e/1?pq-origsite=gscholar ).  Psychiatric medications, he wrote, "create perturbations in neurotransmitter functions."  The brain must then compensate to adapt to "alterations in the environment."  Chronic administration of the drugs, he added, cause "substantial and long-lasting alterations in neural function." 

Referring to his own LSD trip, immediate past President of the APA, Dr. Jeffrey Lieberman, wrote: "My [LSD] trip did produce one lasting insight, though--one that I remain grateful for to this day...I marveled at the fact that [if] such an incredibly minute amount of a chemical...could so dramatically alter my cognition, the chemistry of the brain must be susceptible to pharmacologic manipulations in other ways, including ways that could be therapeutic."  ( http://www.huffingtonpost.com/dj-jaffe/book-review-shrinks-the-u_b_6924810.html )

We, as a nation, are reaping the fruits of this historically unprecedented, massive-scale experimentation on the chemistry of the human brain. 

When most mass shooters were taking psychotropic drugs, it's an insult to what's left of our collectively numbed intelligence to suggest that more psychotropic drugs are the answer to mass shootings.  If psychotropic drugs were the answer, then the astronomical increase in Americans' use of psychiatric drugs should have led to a dramatic decrease in the number of mass shootings, not an increase.  Experience shows that more mental health treatment with psychiatric drugs will lead to more mass murder, not less.

Take, for instance, the case of Bradley Stone.  Not unlike Charlie Gordon in Flowers for Algernon, Mr. Stone might once have been considered a darling example of the shining success of mental health diversion courts and Assisted Outpatient Treatment (AOT) of the kind advocated by Rep. Tim Murphy (R-PA) in his proposed Helping Families in Mental Health Crisis Act (HR 2646) - that is, until Mr. Stone shot and chopped up seven people, before poisoning himself with the Risperdal and Trazodone he was prescribed and then stabbing himself ( http://www.montcopa.org/ArchiveCenter/ViewFile/Item/2128 ). Or there's Spc Ivan Lopez-Lopez who in the months preceding the second deadly Ft. Hood shooting spree voluntarily met with a half dozen Army mental health providers at Ft. Bliss, Ft. Leonard Wood, and Ft. Hood on ten occasions, dutifully refilling prescriptions for psychotropic medications ( http://www.pharmabuse.com/blogs/98 ).

At the very least, we know psychotropic drugs do not prevent mass killings, since toxicology results for most of the aforementioned dead mass shooters revealed the prescribed drugs were still in their blood.  Moreover, the FDA has received 765 reports of homicide as a side effect of psychotropic drugs, many of which were multiple homicides.  Just as the now well-established link between antidepressants and suicidality, which prompted a black box warning, was once covered up, the extent of the temporal link between psychotropic drugs and violence toward others has been concealed from the American public.  Now, thanks to a recent Freedom of Information Act (FOIA) lawsuit filed against the FDA, we're obtaining the relevant adverse event report records, and they will be made public for the first time.

The FDA adverse event records support recent scientific studies finding a link between psychotropic medications and homicide ( see http://ki.se/en/news/study-analyses-link-between-psychotropic-drugs-and-homicide-risk and http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0015337 ).    

U.S. taxpayers should not spend more money on mental health programs promising to prevent mass shooting tragedies, because such undoubtedly costly programs, by the very nature of their promise, would be fraudulent.  If anything, Congress should investigate whether psychotropic drugs, which have been demonstrated time and time again as being incapable of preventing homicide, may actually be living up to their scary label warnings.

The guns versus mental health debate is a red herring.  They are two sides of the same coin - emphasis on coin, as in money.  The gun lobby and the pharma lobby are a marriage made in heaven (or, more aptly, hell).  We're hearing from the gun lobby that more guns would help victims protect themselves from psychotic mass shooters.  We're hearing from the pharma lobby that forced mental health treatment with psychotropic drugs, which the mass shooters were already voluntarily taking, would prevent mass shootings.    

The only lobby seemingly letting a crisis go to waste is the entertainment lobby.  We haven't heard that more violent video games and movies would prevent mass shootings -- yet.
Statistics show that gender, race, geography, insurance, and income are the greatest risk factors that determine the likelihood that your child will be diagnosed with ADHD.

13.7% of boys in the U.S. are diagnosed with ADHD versus 5.9% of girls in the U.S.

11.5% of Native American children in the U.S. are diagnosed with ADHD versus 2.5% of Asian children in the U.S.

18.7% of kids in Kentucky have been diagnosed with ADHD versus 5.6% of kids in Nevada.

13.1% of children on Medicaid are diagnosed with ADHD versus 8.4% of children on private insurance versus 6.2% of children with no insurance.

13.1% of children whose family income is below the poverty threshold are diagnosed with ADHD versus 8.9% of children whose family income is 200-399% above the poverty threshold.

Still think ADHD is a disorder stemming from a chemical imbalance in the brain?

 

Parents who want alternatives to mental health drugs, suggested by teachers, mental health professionals, doctors or ex-spouses, may be relieved to know that there is a medical test that can be performed to evidence whether your child can even metabolize the drug that is being proposed.

 

This test has been around for a long while, yet the medical community has not used it nor made it broadly known as it may cut into pharma spending. The test is a genomic test, meaning it tests the DNA function and structure and through this, can determine if the individual can break down the drug and move it through the body or will the liver become overwhelmed and the individual become toxic, and therefore experience the adverse effects of the mental health drugs, such as psychosis, worsening depression, anxiety, mania, delusions, suicidal thoughts, homicidal thoughts and more.

 

Like all things in our culture and in our society that revolves around money, the test is currently being used and promoted for use to the psychiatric community.  Now, if the use of it were as healthful as what has been suggested above, in order to test the individual to see if they will be able to metabolize the drug, therefore they would most definitely be wise to learn of the alternative, non pharmaceutical treatment, then we would live in an ideal world. Yet, that is not the intention, nor the purpose for promoting this test to the psychiatric community.  Mental health professionals are using the test in order to find the drug that rates “best” in their estimation. (Please refer to the FDA warnings on mental health drugs to understand the risks they carry, www.fda.gov). Mental Health drugs cannot rate "best" in any estimation.

 

In a highly scientific article regarding this genomic testing, the facts relayed are as follows.  “drug-metabolizing enzyme genes, such as cytochrome P 4 5 0 2D6 gene (CYPD6), were identified.” That’s the good news.  The genes that partake in metabolizing drugs were identified through genomic research.

 

The article continues, with the benefit of this news as it “provides clinicians with the opportunity to identify both poor metabolizers and ultrarapid metabolizers…”

 

The article does point out that “In recent years, the potential iatrogenic harm (illness caused by the drug) associated with psychotropic medications has become increasingly obvious, with “black-box warnings” being attached to antidepressants, antipsychotic medications, stimulants, and mood stabilizers.”

 

Again, this is not necessarily new technology, this is new to the public, “The identification of specific gene variants associated with idiosyncratic responses is about 50 years old, and the recognition that some psychiatric patients metabolize antidepressants at dramatically different rates has been documented for several decades.”

 

Some information for those parents who want to approach their doctors to do this testing and assert their right to alternative treatment for their child:

 

“CYP2D6 was the first drug-metabolizing enzyme gene that was genotyped to identify psychiatric patients with increased or decreased metabolic capacity.  It is located on chromosome 22 and consists of 4382 nucloetides…

 

The CYP2DC enzyme plays a primary role in the metabolism of more than 70 substrate medications, including twelve psychotropic medications…

 

The most important CYP2D6 phenotype to identify is the poor 2D6 sustrate metabolizer phenotype. Patients who are poor metabolizers are at increased risk of adverse events when they are prescribed 2D^ substrate medications, because of their low metabolic capacity.”

 

 

For more factual information that helps to get you fully informed on your rights in the field of mental health, visit www.mentalhealthrights.org

 

 

 

Source:

 

Psychiatric pharmacogenomics testing in clinical practice, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181940/

Testimony of Patti Johnson
Colorado State Board of Education member
2nd Congressional District
before the
U.S. House of Representatives
Subcommittee on Oversight and Investigations hearing entitled
"Behavioral Drugs in Schools: Questions and Concerns"

September 29, 2000


I have been a member of the Colorado State Board of Education for the last six years. One of my platforms when I ran for office was to empower parents in their right to direct the upbringing and education of their children.


Over the years I was contacted by a number of parents who had been pressured to put their children on various psychotropic drugs for a variety of so-called learning disorders, the most common of which was Attention Deficit Hyperactivity Disorder (ADHD). In some cases they were told their child would not be allowed to attend school if he did not begin taking psychotropic drugs.


One parent who was given the option of placing her son on a stimulant drug or removing him from school elected to home school her son. She told me that it just didn’t make sense that a straight A student would be labeled "learning disabled." A Douglas County parent I spoke with said she was told her son had ADHD. What she was being told about the behavior her son supposedly exhibited and what she observed were not consistent. She investigated the matter and the school’s special education director eventually admitted that she had coaxed the teacher to answer the questions of the checklist used to determine if the child had ADHD in a certain manner so her son "would get the help he needed." This infuriated her so badly she removed her son from the school.


A Jefferson County parent who contacted me said he at first complied with the school’s direction to have his son take a stimulant drug. The drug caused his son to become violent, he began taking steak knives out of the kitchen and stabbing his stuffed animals. When the parent took him off the drug, the principal of the school began pressuring him to resume the stimulant -- so much pressure that the matter is now in court and the father could forfeit parental rights if he disagrees with the decision of the court on whether or not to place his child on Ritalin. Many more examples exist.


When I investigated the issue I realized that the so-called psychiatric learning disorders are an effort to "medicalize" failures in instruction and discipline at the expense of the child’s well being and the rights of the parent. Some of the learning disorders listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM) illustrate this point.


For example, the fourth edition lists number "315.1, Mathematics Disorder." The diagnostic criteria for this is "Mathematical ability, as measured by individually administered standardized tests, is substantially below that expected given the person’s chronological age, measured intelligence, and age-appropriate education." Likewise, the diagnostic criteria for "315.2, Disorder of Written Expression" labels the child with this disorder if he scores low on written tests.


The label of ADHD is assigned if the child exhibits such symptoms as not listening when spoken to, is forgetful, fails to finish homework, fidgets, talks excessively, etc. -- the typical behavior of a normal child. Parents of children said to have these disorders are generally told that it is a neurological disorder or a chemical imbalance in the brain. Yet, at a Consensus Development Panel conducted by the National Institutes of Health on ADHD in November 1998, it was reported that "We do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction. Further research to establish the validity of the disorder continues to be a problem. This is not unique to ADHD, but applies as well to most psychiatric disorders..."


Educators are not allowed by law to practice medicine. Yet, the adjudication a child has one of these "disorders" and should be placed on "medication" and into special education is often done by a team which includes the parent, a teacher, a social worker, a special education teacher and the principal. The above factors led me to introduce a resolution before the Colorado State Board of Education entitled "Promoting the use of academic solutions to resolve problems with behavior, attention and learning." It reminded educators that their role was to teach and urged them to refrain from advising parents on medical matters. This was passed by a vote of 6 to 1 by the Board in November 1999.


Unfortunately, financial incentives exist for schools to label children with learning disorders. Understanding these incentives requires a brief review of the laws that affect special education.


The legislation which is now the Individuals With Disabilities Education Act (IDEA) was originally the Education for all Handicapped Children Act of 1975. The intent of this legislation was to ensure that children with actual physical handicaps -- sight impairment, hearing loss, etc. -- were given the public education they are entitled to.


This law was reauthorized in 1990 and the name changed to the Individuals with Disabilities Education Act. There were few procedural changes but the term "handicapped" was changed to "disabilities." The following year a memo was issued by the US Dept. of Education Office of Special Education and Rehabilitative Services which stated a child could qualify for special education if he was determined to have ADHD.


At this time, the IDEA legislation provided schools with an additional $400 per year for each child in special education. There followed a dramatic spike in the amount of methylphenidate consumed in the US. According to the DEA, the production and use of methylphenidate increased almost 6 fold between 1990 and 1995.


In IDEA as passed in 1999, the impairment category of "emotional disturbance." is defined in part to say the child has "An inability to learn that can not be explained by intellectual, sensory, or health factors." There is no mention of the fact that this may be due to a failure to instruct properly.


In December 1999, the Los Angeles Times reported that tens of thousands of California’s special education students were placed there not because they have a serious mental or emotional handicap, but because they were never taught to read properly. Reid Lyon, head of the federal government’s research efforts into reading and writing told the Times, "It’s where children who weren’t taught well go in many cases."


The intent of the original law, the Education for all Handicapped Children Act of 1975, was to ensure those with physical disabilities received a free and appropriate public education. These children are now being shortchanged because such a large percentage of special education funds are being diverted to vague psychiatric diagnoses. In 1998, 51.1 percent of special education children were in the category of "specific learning disabilities." These are the psychiatric diagnoses such as Mathematics Disorder, Disorder of Written expression and ADHD. Other disability categories also include psychiatric diagnoses.


IDEA legislation also contains a "child find" provision which requires states to actively seek out any children who may qualify for special education in order to receive federal special education funds. The child find program starts at birth in Colorado. This, of course, serves to push up the numbers of children labeled with ADHD.


The so-called learning disorders have, sadly, become a way for financially strapped schools to make ends meet. In many states, schools have become authorized Medicaid providers and funds can be collected in behalf of a child labeled with one of the learning or behavior disorders. This can be such a lucrative cash cow that in a letter dated October 8, 1996, the Illinois State Board of Education strongly encouraged the superintendent of one of its districts to participate in Medicaid incentives. The letter stated that Illinois had received $72,500,000 in federal Medicaid money in 1996 and that Medicaid dollars have been used for a variety of non-medical purposes and that "the potential for the dollars is limitless."


To assist schools in identifying children to label with "learning disorders," a number of checklists are made available to schools through the ERIC (Educational Resource and Information Center) database, which is a federal clearing house for educational materials. Yet, despite the expense created by such actions, these children are not receiving the education they are entitled to. Though the standards set for special education children are often lower, their graduation rate in the 1995 -1996 year was only 28.9 percent!


To the degree educators are expected to diagnose children, they are being distracted from their main duty which is to provide our children a quality education. Our schools are the only institution entrusted to attend to the academic needs of our children and their mission must not be diluted. I urge this committee to do everything in its power to get schools out of the business of labeling children and back to the job of teaching.


Thank you.


Patti Johnson
Colorado State Board of Education
Second Congressional District

Myths # 1-7: ADHD Drugs Improve Academic Performance (1) and Social Relationships (2); Reduce Depression (3), Substance Abuse (4), and Driving Accidents (5); and Promote More Stability in Employment (6) and Extra-Curricular Activities (7)

Mallinckrodt Methylin patient brochure: "Without diagnosis and proper management, ADHD can have devastating consequences, including failure in school, depression, violent behavior, substance abuse, relationship problems, and failure to keep a job."

FDA Response: "While the presentation excerpted above does not directly assert that Methylin will correct the problems of untreated ADHD, it is nevertheless misleading because it implies, in the context of the piece as a whole, that Methylin may reduce the likelihood or severity of the consequences of untreated ADHD listed above (i.e., poor academic performance, poor social-emotional development, violent behavior, substance abuse, and employment problems) when this has not been demonstrated by substantial evidence or substantial clinical experience. While Methylin is approved for the treatment of attention deficit disorders based on a demonstration of bioequivalence with the reference listed drug (RitalinCI (methylphenidate hydrochloride)), we are not aware of substantial evidence or substantial clinical experience demonstrating a positive effect of treatment with Methylin (or of treatment with the reference listed drug) on the outcomes listed above (i.e., academic performance, depression, violent behavior, substance abuse, and stable employment). If you have such data, please submit them to FDA for review."

Novartis Focalin XR web page: "Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), if untreated, are at risk for poor academic performance. Teen pregnancy, problems with peers, car accidents, and physical injuries occur at a higher rate. Untreated, children and teens with ADHD are also at risk of conduct disorders, delinquency, and drug or alcohol abuse. Typically, adults with untreated ADHD experience academic hardships. These often start in childhood and are likely to worsen during college years. Untreated adults take longer to complete learning degrees. They are likely to have lower economic status, lower rates of employment, and more work-related problems. Untreated adults also have more problems in their relationships, more driving accidents, and more addiction—from alcohol to gambling. Living with ADHD doesn't have to be this way. People with ADHD have treatment choices. The results of untreated ADHD are serious and should not be ignored. There is no cure for ADHD. Proper treatment can help control symptoms, helping to reduce these risks."

FDA Response: "While these presentations do not directly assert that Focalin XR will correct the problems of untreated ADHD or lead to the hoped for outcomes, they are misleading nonetheless because the only sensible interpretation of placing the consequences of untreated ADHD in pieces promoting the use of Focalin XR for ADHD is to imply that Focalin XR may reduce the likelihood or severity of the consequences of untreated ADHD listed above (i.e., poor social–emotional development and job success, poor academic performance, impaired driving, smoking and substance abuse) and induce the desired treatment outcomes when this has not been demonstrated by substantial evidence or substantial clinical experience... While Focalin XR is indicated for the treatment of ADHD, FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Focalin XR can help patients avoid these consequences."

Johnson & Johnson Concerta professional convention panel: "CONCERTA® helps children improve academic performance throughout the day."

FDA Response: "This presentation is misleading because it implies that use of Concerta will lead to an improvement in academic performance throughout the day when this has not been shown by substantial evidence or substantial clinical experience."

Johnson & Johnson Concerta web page: "Adolescence is a time of greater independence and responsibility. For most teens, the after-school hours are filled with plenty of activities, including: sports, clubs, part-time jobs, socializing with friends, household chores, and, of course, homework. ADHD can have an impact on all of these activities, so you want to be sure your teen's medication is doing its job. CONCERTA® provides consistent symptom management throughout the day, for up to 12 hours, helping your teen focus and manage behavior. This may benefit your teen's ability to socialize with family and friends, and pursue interests and hobbies outside of school. You also won’t have to worry about whether your teen needs another dose of medication, because a single dose in the morning is all it takes. As a parent, you naturally want your teen to do well in all areas of his or her daily life. With once-daily CONCERTA®, you can be confident that symptoms are being managed no matter what he or she is doing."

FDA Response: "This presentation is misleading because it asserts improvement with Concerta in a broad array of adolescent after school activities, such as athletics, clubs, and performance in part-time jobs, when this has not been demonstrated by substantial evidence. While Concerta has been shown to improve total scores on the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS), which measures ADHD symptoms such as fidgeting, not listening, and talking excessively, what has not been shown is that this improvement in ADHD-RS total scores is correlated with a positive effect on adolescents’ ability to pursue interests and hobbies outside of school and to do 'well in all areas of [their] daily life.'"

Myth # 8: People Treated With ADHD Drugs Are Less Likely To Commit Suicide

BMJ study: "At the population level, drug treatment of ADHD was associated with an increased rate of suicide related events (hazard ratio 1.31, 95% confidence interval 1.19 to 1.44)."

Myth # 9: ADHD is genetic, or neurobiologic, or caused by a chemical imbalance in the brain.

WHO study: "An average of 50% of children with ADHD (range: 32.8%–84.1% across countries) continued to meet DSM-IV criteria for ADHD as adults."

If ADHD is genetic, neurobiological or due to a hard-wired chemical imbalance in the brain, then why do half of children diagnosed with ADHD outgrow it by the time they reach adulthood? Can you outgrow Down syndrome? Cerebral Palsy?

Myth # 10: Only ADHD Drugs Reduce ADHD Symptoms.

Journal of Developmental and Behavioral Pediatrics
study: "One meta-analytic review of the effects of stimulant medication on ADHD children found an average effect size of 0.32 for response to administration of a placebo, indicating that there was approximately 30% improvement in children with ADHD who were given a placebo compared with children with ADHD who were given nothing, although results across studies were highly variable. Several other independently conducted reviews of stimulant medication for children with ADHD also report that the average rate of positive response to placebos ranges from about 20% to 30%."

What? A sugar pill will improve ADHD symptoms by 30%? Without the dangerous side effects?

How can that be?  The study goes on to explain...

"Evidence suggests that parents and teachers tend to evaluate children with ADHD more positively when they believe the child has been administered stimulant medication and they tend to attribute positive changes to medication even when medication has not actually been administered."

The study reveals the fatal flaw with diagnosing ADHD in the first place and when measuring the effects of stimulant medication on ADHD symptoms, namely that it's all in the eye of the beholder, ie. subjective... 

"The fact that subjective measures are the most widely used measures of treatment response in children with ADHD argues for the need to better understand how medication expectancies influence these measures and argues for the need to design trials that can accurately assess the direct pharmacologic effects separately from placebo effects."

NIMH 3-year follow-up study and 8-year follow-up study find that ADHD medication is no more effective than non-medication therapy.


In her opinion piece in the New York Observer "How Esquire Got ADHD Wrong," Gina Pera gets it wrong. Ms. Pera's critique of Ryan D'Agostino's article in Esquire "The Drugging of the American Boy" falls short, if her intent was to cast doubt on the validity of the facts reported in Mr. D'Agostino's article.


Ms. Pera writes, "Never considered by the editors or the writer, Ryan D’Agostino: the story’s compounding of stigma already suffered by millions of children, teens, and adults with ADHD and the people who love them." To make her point, Ms. Pera then proceeds to ridicule a person with ADHD, writing, "Only one man, Esquire reports, bravely says, 'Stop drugging our boys!' He learned about ADHD not by studying it (that’s obviously the girly way) but by having it himself." Ms. Pera sticks up for stigmatized people diagnosed with ADHD everywhere by making fun of someone with ADHD, joining the irrational ranks of death penalty proponents who advocate killing people to show people that killing people is wrong. Irony abounds in Ms. Pera's piece, as she then goes on to accuse Esquire and Mr. D'Agostino of siding with “deniers of ADHD – the anti-vaxxers of psychiatry” while citing 10,000 unnamed studies that she claims substantiate ADHD as a valid diagnosis, yet have inexplicably failed to prove chemical imbalance theory despite massive Big Pharma underwriting, much to the disappointment of ADHD-hockers – the snake oil salespeople of modern pseudo-science.


Ms. Pera, whose livelihood presently depends on you believing that ADHD is real, is intellectually dishonest when she characterizes Mr. D'Agostino's exhaustive effort, sarcastically or not, as relying solely on the word of one ostensibly uneducated man with ADHD. It is not entirely clear to this reader whether Ms. Pera was deriding Howard Glasser in her piece, who Mr. D'Agostino reports as having ADHD-like symptoms during childhood but never definitively says was diagnosed with the condition, or Dr. Ned Hallowell, a psychiatrist also cited in Mr. D'Agostino's article, who was reportedly diagnosed with ADHD. If she was referring to Mr. Glasser, then Ms. Pera, a self-styled expert on ADHD with no alphabet soup after her name, has armchair diagnosed Mr. Glasser with ADHD, as proponents of the condition often do, and has also omitted that Mr. Glasser has a bachelor's degree in psychology and a master's in counseling. If Ms. Pera was referring to Dr. Hallowell, then she is just plain confused. Moreover, whereas Mr. D'Agostino cites multiple studies, psychologists and a psychiatrist by name in his article, Ms. Pera cites no study, no psychologist, and no psychiatrist by name. To her credit, though, she does cite one fellow blogger by name.


In defense of ADHD drugs, Ms. Pera writes, "With careful trial and error over time, the medications can be adjusted to maximize positive effect and minimize negative effect." Perhaps Ms. Pera should tell that to the relatives of the 531 who have reportedly died, or to the 691 who had life-threatening emergencies, or the 3,737 who were hospitalized on ADHD medications (Source: Food and Drug Administration Adverse Event Reporting System Q1 2004 – Q3 2012). Trial and error is what one does with lab rats and guinea pigs, not children. Unfortunately, since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, Big Pharma has been allowed to fast-track FDA approval of drugs without adequate clinical trials upon payment of a bribe – scratch that – fee to the FDA. Post-marketing surveillance, when unproven and potentially dangerous drugs are unleashed on the unsuspecting public, has become the new clinical trial, with the FDA leveraging the AERS to manage the clinical trial on a national scale with our children as test subjects, issuing drug warnings only after children needlessly suffer and even die. For instance, after reviewing AERS data in 2006 – long after the drugs had been approved for use on the general population – the FDA's Division of Drug Risk Evaluation (DDRE) issued a report recommending changes in ADHD drug prescribing information to include warnings about psychosis, mania, hallucinations, aggression, and violent behavior; and recommended further evaluation regarding suicidality.


The FDA wrote in its post-marketing review, “The most important finding of this current review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors at usual doses of any of the drugs currently used to treat ADHD. The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking...”


While Lilly's drug Strattera already contains a black-box warning – the strongest possible – regarding suicidality, other ADHD drugs carry no warnings about suicidal ideation, despite at least 707 completed suicides, 731 suicide attempts and 1,567 occurrences of suicidal ideation reported to the FDA involving those medications (Note: Strattera reports not included in count). Presumably, the FDA is still conducting a post-marketing review of the suicidiality risk of the other ADHD drugs, some eight years after their initial post-marketing recommendation for further evaluation. Tick tock goes the clock.


In addition to the overwhelming empirical data casting doubt on the safety of ADHD drugs, there has been a steady stream of anecdotal media reports of children with no prior history harming others while reportedly on ADHD medications, which are known to increase the likelihood of aggression and violent behavior. Meanwhile, the media have been bereft of any serious inclination to investigate what the public-at-large has already figured out on its own. If a junior high school gymnasium roof collapsed killing hundreds of kids at once, the media would be camped outside with satellite trucks for weeks covering the story. Instead, our nation's drugged youth are dying in the hundreds one by one in silence: drip drop, drip drop.


While Ms. Pera recommends trial and error with medications over time, time does not favor ADHD medication efficacy, as supported by the authoritative three-year and eight-year follow ups to the fourteen-month Multimodal Treatment Study of Children With ADHD (MTA). Ms. Pera would have people run the risk of serious adverse effects without any demonstrable long-term benefit versus not taking medication. The eight-year follow up to the MTA further revealed that those continuing to take medication over time had to take on average a roughly forty-five percent higher daily dose than at fourteen months to achieve an equivalent level of functioning to those not taking medication. Yes, you read correctly, over time you will need to take more medication to have the same effect as not taking medication.


It is important to note that the above referenced adverse reports do not even include anti-psychotics such as Seroquel, Risperdal and Abilify which are increasingly prescribed off-label for ADHD at an alarming rate, and carry with them equally troubling side effects and warnings. Ms. Pera, along with other ADHD diagnosis and drug proponents, may seek to attack the data cited herein, but at least this writer is offering data, rather than mere platitudes. The reader is encouraged to consider how the aforementioned may attempt to distort the data, excluding preexisting conditions and concomitant drug use, which has the effect of understating the risks of ADHD medications and ignores the realities of everyday life and poly-pharmacy in America. Drug advocates will downplay the role of ADHD medication, for example, if an autopsy uncovers a congenital heart defect, even though the patient did not expire from the preexisting condition prior to taking a stimulant drug bearing a warning of higher risk of serious cardiovascular adverse events, and notwithstanding the fact that people with congenital heart defects can live a long life without ever experiencing any symptoms or requiring treatment. Likewise, if a patient taking stimulants is also prescribed a Benzodiazepine in order to counteract the known side effect of insomnia associated with ADHD drugs, and/or is prescribed an anti-psychotic to negate the known side effect of psychosis related to ADHD drugs, and then ends up committing suicide, the respective drug manufacturers will point the finger at one another while the FDA quietly applies an algorithm to minimize the weight of the drug-induced death in their risk calculations.


Perhaps the most outlandish rebuttal that Ms. Pera offers to Mr. D'Agostino's article highlighting the very real over-diagnosis and over-medication of American boys is when she writes, "In children and teens, males are diagnosed at greater rates than females. But by adulthood, the number is more even." First, and most obviously, Mr. D'Agostino's article is entitled “The Drugging of the American Boy,” not “The Drugging of American Men.” As such, statistics relating to women with so-called Adult ADHD, undoubtedly a target demographic for growth-hungry pharmaceutical companies, are irrelevant to Mr. D'Agostino's topic. Besides, even if the adult diagnosis ratio is 1:1 for men and women, that means there are still six times more males diagnosed with ADHD than females in their lifetime. Women would have to be diagnosed at a rate of 6 to 1 in adulthood to catch up to men, making the over-diagnosis of boys with ADHD obvious to anyone with basic math skills and an open mind. For Ms. Pera's argument to have any validity whatsoever, girls would have to be going undiagnosed with ADHD 6 to 1 over boys in childhood, or perhaps even more since some chemical imbalance flat-earthers would still illogically argue that many boys are going undiagnosed to this day. If such were the case, it would seriously invalidate the already questionable diagnostic tests (e.g. Conners Behavior Rating Scale, Vanderbilt Assessment Scale, Achenbach Child Behavior Checklist, etc.) long touted by the Psycho-Pharma industry as being scientific, but recognized by most as nothing more than subjective checklists blissfully unencumbered by etiology. Of course, the idea pushed by Ms. Pera and her ilk that ADHD is still under-diagnosed strains credulity, in light of Dr. Stephen Hinshaw and Dr. Richard Scheffler's recent contributions. How anyone could say with a straight face that a sizeable percentage of school children in America today continue to go undiagnosed is beyond comprehension.


Lastly, Ms. Pera leaves us with the parting reassurance that, despite the lack of evidence of long term benefits of ADHD medications and in spite of compelling evidence of the serious health risks they pose, many automobile accidents and sports injuries have been avoided thanks to ADHD medications. Ms. Pera's claims bear an eerily striking resemblance intellectually to the oft-trumpeted justification of the erosion of our civil rights in order to protect us from external threats. Like the hawks who justify eavesdropping because of countless, albeit undisclosed, terror plots thwarted; Ms. Pera would tell us how many accidental deaths have been averted by ADHD medications if she could, but she cannot.


Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD): Patient/Parent Support Group or Mental Health Industry/Big Pharma Front Group?


The event was sponsored by the local chapter of Children and Adults with Attention Deficit Disorder (Chadd), the nation’s primary advocacy group for A.D.H.D. patients... The evening opened with the local Chadd coordinator thanking the drug company Shire — the manufacturer of several A.D.H.D. drugs, including Vyvanse and extended-release Adderall — for partly underwriting the event. An hourlong film directed and narrated by two men with A.D.H.D. closed by examining some “myths” about stimulant medications, with several doctors praising their efficacy and safety. One said they were “safer than aspirin,” while another added, “It’s O.K. — there’s nothing that’s going to happen.”


Sitting in the fourth row, Mr. Fee [whose son took his own life while strung out from Adderall addiction]raised his hand to pose a question to the panel, which was moderated by Jeffrey Katz, a local clinical psychologist and a national board member of Chadd. “What are some of the drawbacks or some of the dangers of a misdiagnosis in somebody,” Mr. Fee asked, “and then the subsequent medication that goes along with that?”


Dr. Katz looked straight at the Fees as he answered, “Not much.” Adding that “the medication itself is pretty innocuous,” Dr. Katz continued that someone without A.D.H.D. might feel more awake with stimulants but would not consider it “something that they need.” “If you misdiagnose it and you give somebody medication, it’s not going to do anything for them,” Dr. Katz concluded. “Why would they continue to take it?”


Excerpts from Drowning in a Stream of Prescriptions, New York Times, Feb. 2, 2013

Alan Schwarz's poignant New York Times article about the heart-breaking tragedy of a young man's promising life ended prematurely by an addiction to ADHD medication, and his parents' anguish as they tried in vain to stop professionals from prescribing more medication while their son continued to spiral downward, raises important questions about the role of so-called patient/parent associations in promoting controlled stimulants and other ADHD drugs to the general public.


That the risks of ADHD medications would be minimized at a Shire-sponsored event is not exactly ground-breaking news. Shire's advertising and marketing of its ADHD medications has a long history of running afoul of the U.S. Food and Drug Administration (FDA) Division of Drug Marketing, Advertising and Communications (DDMAC). The FDA has sent warning letter (Nov. 9, 2000), after warning letter (Sept. 25, 2008), after warning letter (June 22, 2010), after warning letter (May 6, 2011) to Shire for its false advertising and marketing of its ADHD drugs Adderall, Adderall XR, Intuniv and Vyvanse respectively.


A day before Schwarz's article appeared in the New York Times, Business Week reported that Shire "agreed to pay about $57.5 million to resolve a federal investigation into the marketing of its drugs for treating attention deficit hyperactivity disorder." Shire's 10-K filed with the SEC states, "On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covered whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act. On February 1, 2013 the Company announced it had reached an agreement in principle to resolve this matter. The Company has recorded a $57.5 million charge comprised of the agreement in principle amount, interest and costs... Discussions between the Company and the US Government are ongoing to establish a final resolution to the investigation."


In fairness to Shire, though, they are not the only pharmaceutical company to engage in false advertising and marketing of ADHD medications. The FDA has also sent a warning letter or notice of violation to Strattera manufacturer Eli Lilly & Company, Methylin manufacturer Mallinckrodt Inc., Focalin XR manufacturer Novartis, and Concerta manufacturer Johnson & Johnson.


The FDA's repeated false advertising and marketing complaints against ADHD drug manufacturers often involve the following misleading practices: overstatement of efficacy, broadening of indication, unapproved uses, ommission or minimization of risk information, omission of material fact, unsubstantiated claims and unsubstantiated comparative claims.


While pharmaceutical companies misleading consumers is not exactly news-making, what is revelatory and indeed troublesome about Schwarz's article is that a so-called patient or parent association, through its Board member who is also a licensed psychologist, is reported to have engaged in similar misleading practices, ie. downplaying the risks of ADHD medications.


This is not the first time concerns have been raised about so-called "parent associations" advocating the use of stimulant medications. As early as 1995, in their annual report, the United Nations (UN) International Narcotics Control Board (INCB) asked U.S. authorities to investigate "whether article 10, paragraph 2, of the 1971 Convention [on Psychotropic Substances], prohibiting the advertisement of controlled substances to the general public, is not being undermined by the activities of 'parent associations' advocating the use of methylphenidate [the active ingredient in the ADHD drugs Ritalin, Concerta, Daytrana, Quillivant XR, etc.]."


It is understandable why the U.S. government might not want to seriously look into these allegations, as they would in effect be investigating themselves. What Schwarz doesn't tell you in the article is that the part of the CHADD meeting not underwritten by Big Pharma, was underwritten by - wait for it - you. That's right, CHADD has received $12,412,919 of your tax money in grants from the U.S. Department of Health and Human Services (HHS) to reportedly facilitate the promotion of controlled stimulants to the general public, while simultaneously downplaying their risks, in seeming violation of the 1971 Convention on Psychotropic Substances, which the U.S. signed on February 21, 1971 and ratified on April 16, 1980, and the False Claims Act.


Quite the self-sustaining eco-system: Shire pays HHS $57.5M to end a federal investigation into alleged false claims about their ADHD medication, and meanwhile HHS pays out $12.4M to CHADD, which reportedly makes false claims about Shire's ADHD medications at patient/parent meetings. However, the pharmaceutical industry's financial support of CHADD goes far beyond the apparent indirect conduit via HHS, and includes direct contributions to CHADD as an organization, as well as personal payments to individual members of CHADD's Board of Directors and CHADD's Professional Advisory Board.


From 2006 through 2009, ADHD drug manufacturers contributed $7,078,050 to CHADD as an organization. Pharmaceutical companies have also personally paid current CHADD Board of Directors member Anthony Rostain, current CHADD Professional Advisory Board Member Craig Surman, and past CHADD Professional Advisory Board members Rahn Bailey, Marcus Griffith, Patricia Quinn, Adelaide Robb and Timothy Wilens to the tune of $743,646 collectively. (Source: ProPublica.org Dollars for Docs).


The cited figures are by no means exhaustive, and merely represent the contribution and personal payment amounts that the pharmaceutical companies and CHADD have chosen to report thus far. While the full scope of the payola from Big Pharma to CHADD may not be ascertainable at this time, the data that is available attests irrefutably to Big Pharma's significant financial support of CHADD as an organization, as well as its considerable financial support of individuals with authority and influence inside CHADD.


With so much Big Pharma money ending up in CHADD's bank account and in the pockets of CHADD leaders, it really begs the question as to whether patient or parent association is even an accurate description of the true nature of the organization. Remember, Schwarz refers to CHADD as "the nation's largest advocacy group for A.D.H.D. patients." CHADD is an advocacy group alright, but for whom exactly?


A review of CHADD's tax documents dispels any remaining illusion that it is an advocacy group for, by or of ADHD patients or their parents. CHADD's tax returns tell the real story: "THE ORGANIZATION'S MEMBERS DO NOT HAVE POWER TO VOTE. THEY PAY DUES THAT ENTITLE THEM TO... CHADD UNA DISCOUNT PRESCRIPTION CARD..."


So if ADHD patients and their parents are not calling the shots inside CHADD, who is? A review of CHADD's income and expenditures from 2001 to 2009 (the only years available) reveals that Celltech (UCB Pharma), Cephalon, Eli Lilly, Janssen (Johnson & Johnson), McNeil (Johnson & Johnson), Novartis, Pfizer, Shire and UCB Pharma have contributed to CHADD over the years, though CHADD won't say exactly how much.


What does all that Big Pharma money buy? If we take Shwarz's account of one CHADD event as an example, apparently it buys plenty - a poorly disguised direct promotional pitch of ADHD drugs to patients and parents, where even CHADD Board of Directors member Jeffrey Katz gets in on the act, throwing the weight of his psychology license behind a campaign to promote ADHD drugs that minimizes their risks to both patients and parents alike in the audience.


This type of apparently false direct-to-patient and direct-to-parent advertising campaign cloaked as grassroots "Parent-to-Parent: Family Training on AD/HD" sponsored by Big Pharma (see, for example, CHADD's income and expenditures reports and Big Pharma's donations to "CHADD Public Education and Outreach," "Parent to Parent: Family Training on AD/HD," "CHADD Education Initiative on AD/HD," etc.) appears to be a clever attempt to circumvent the jurisdiction of the FDA's DDMAC, which according to its own literature is limited to reviewing labeling and advertising distributed by the manufacturer.


The tight alignment of finances and mutual interests between Big Pharma and CHADD seems to be paying dividends for the ADHD drug manufacturers. In the two plus decades since CHADD's inception, prescriptions for stimulant medications used to treat ADHD have increased more than ten-fold, from 4 million per year in 1990 to 45 million per year in 2010 (Source: National Institute on Drug Abuse, Prescription Drugs: Abuse and Addiction).


Sounds like a reason to celebrate. So it shouldn't be a surprise that Big Pharma footed the $114,950 bill for CHADD's 20th Anniversary Gala.