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Florida Department of Children and Families Records Reveal No Lessons Learned from 7-Year-Old Gabriel Myers' Death

On April 16, 2009, 7-year-old Gabriel Myers is believed to have hanged himself in the shower of his Margate foster home. The toxicology report came back positive for amphetamine, fluoxetine, and olanzapine. A coroner's review of medical records indicated that psychiatrist Dr. Sohail Punjwani had prescribed young Gabriel 50 mg of Vyvanse (lisdexamfetamine) daily, and 25 mg of Symbyax (fluoxetine and olanzapine) three times per day. Approved for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), Vyvanse is an amphetamine class stimulant, which according to the drug's label, "at recommended doses, may cause psychotic or manic symptoms, e.g. hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania." Symbyax is a combination of two other powerful psychotropic drugs, the antipsychotic Zyprexa (olanzapine) and the antidepressant Prozac (fluoxetine).

Broward Deputy Chief Medical Examiner Dr. Stephen Cina noted in the autopsy report, "Olanzapine, either alone or in combination with fluoxetine, is not [approved for use in children]." Indeed, the drug's black box warning – the strongest possible – states emphatically, "Symbyax is not approved for use in children less than 10 years of age."

Reiterating another black box warning about Symbyax, Dr. Cina further noted in the report, "Fluoxetine and olanzapine can increase the risk of suicidal ideation in children taking this drug." Despite concluding that Gabriel's actions led to his demise, Dr. Cina deemed the manner of death to be undetermined, not suicide. Dr. Cina wrote, "It is unclear whether these drugs contributed to this fatality or not."

After conducting 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. 

While questions about Gabriel's death persist even to this day, what is indisputable is that his passing sent shock waves through the Department of Children and Families (DCF), prompting a comprehensive review of how psychotropic medications are administered to foster children in Florida. Commissioned to study the problem and make recommendations, the Gabriel Myers Work Group (GMWG) held public hearings and questioned DCF employees about their practices with regard to psychotropic drugs. The group's findings and recommendations sparked changes in state law, administrative rules, and departmental operating procedures.

Despite official changes in law, policy and procedures, department records reveal that it has been business as usual inside DCF for the last five years, with not much changing in practice with respect to the administration of psychotropic medications to foster children since Gabriel Myers' death.

Chemical Restraint: Without Noted Diagnosis, Foster Children Drugged to Control Behavior

Florida law requires that doctors prescribing psychotropic medications to children in foster care complete a medical report, which must include the child's diagnosis. Florida administrative code further requires case managers and child protective investigators to enter all details and updates about prescribed psychotropic medications in the Florida Safe Families Network (FSFN), DCF's central tracking system, within three business days of the action.

However, DCF records indicate that over the last five years psychotropic medications were prescribed 80,276 times to 25,215 foster children without a psychiatric diagnosis recorded in FSFN.  These lapses in diagnosis annotation in FSFN are contrasted by 39,019 psychotropic medications prescribed to 3,806 foster children during the same period where at least one psychiatric diagnosis was noted in FSFN

So many psychotropic medications being prescribed without a noted diagnosis raises concerns that Florida foster children are being medicated to manage their behavior, rather than to treat a bona fide mental illness.

In recent testimony to the U.S. House Ways and Means Subcommittee on Human Resources, celebrity psychologist Dr. Phil McGraw alerted Congress to the practice of drugging foster children without a diagnosed psychiatric condition: "As I said, and cannot emphasize to you enough, some of these children have no mental illness or disorder whatsoever, yet they are medicated." 

In Florida, chemical restraint is defined as the use of a medication as a restraint to control behavior that is not an accepted treatment for the person's medical or psychiatric condition. Florida administrative code strictly prohibits the administration of medication to foster children for the sole purpose of chemical restraint. 

Teenage Wasteland: Chemical Management of "Adolescence Disorder"

According to the Office of Child Welfare's weekly Meds Report, nearly one-third of all teenagers in foster care are taking one or more psychotropic medications, suggesting that adolescence is one of the most under-diagnosed or under-noted "mental conditions" in FSFN.  As reported by DCF, just 12 percent of foster children of all ages are currently on psychotropic medications, but that rate increases considerably to 30 percent for teenagers aged 13 to 17 in foster care.

Many parents would agree that kids' behavior can be more difficult to manage once they hit puberty. DCF's answer to the age-old dilemma: drug them. 

"These children need to be treasured and protected, and to be given wrap-around loving care," said Dr. Peter Breggin, a psychiatrist who has testified to Congress about the risks of psychotropic drugs and has authored over twenty books, including his latest Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and Their Families. "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."

DCF's War on Boys: Medicating "Y Chromosome Disorder"

From Left to Right: Pasco and Citrus County Child Protective Investigators notably lacking Y chromosomes

While teenagers in Florida foster care are two and a half times more likely to be prescribed psychotropic medications than younger foster children, there is another "mental illness" besides adolescence that puts foster children in the Sunshine State at even greater risk of being chemically restrained.  Roughly half of all foster children, it seems, entered life with a "birth defect", namely with a Y chromosome.

Considering that the vast majority of case managers and child protective investigators are themselves lacking such a chromosome, it is perhaps not surprising that, according to the weekly Meds Report, 63 percent of foster children taking one or more psychotropic medications are in fact boys.


"More boys than girls are given psychiatric drugs because boys can be harder to dominate and to control in our society," said Dr. Breggin. "Also, psychiatry and society in general have set standards for boys which suppress normal boyhood behavior. The greater drugging of boys is one more confirmation that it’s all about control."

"We are pathologizing boyhood," psychiatrist Dr. Ned Hallowell recently told men's magazine Esquire for an article entitled The Drugging of the American Boy.

UCLA geneticist Susan Smalley, Ph.D., who also Co-Chairs the feminist group Equality Now, began research efforts over a decade ago to scan sex chromosomes for clues that could link ADHD genetically to boys. No genetic ADHD link to gender has been identified after years of costly research. 

That the foster care death igniting the firestorm surrounding DCF five years ago involved a boy who was prescribed psychotropic medications is not statistically anomalous. In addition to being prescribed psychotropic medications in Florida foster care at a much higher rate than girls, boys account for nearly three-quarters of the hundreds of pediatric deaths reported to the FDA involving stimulant medications used to treat ADHD.

Comprising nearly two-thirds of the foster children in Florida taking psychotropic medications, boys are disproportionately at risk for serious adverse effects from the medications.

Risky Business: Psychotropic Drugs Prescribed for Unapproved Uses

While many foster children in Florida have been prescribed psychotropic medications over the last five years without a psychiatric diagnosis noted in FSFN, still others do have a psychiatric diagnosis noted in FSFN, but were prescribed psychotropic medications that are not approved to treat their diagnosed condition.

For instance, many foster children with only a diagnosis of ADHD noted in FSFN have been treated with antipsychotics, which are not approved for the treatment of ADHD.  ADHD-diagnosed foster children with no comorbid psychiatric diagnosis noted in FSFN have been prescribed the antipsychotics Abilify (aripiprazole), Clozaril (clozapine), Geodon (ziprasidone), Haldol (haloperidol), Risperdal (risperidone), Seroquel (quetiapine), Thorazine (chlorpromazine), and Zyprexa (olanzapine).

In a recent study published in the Journal of Child and Adolescent Psychopharmacology, researchers found that nearly one-third of foster children aged 2 to 17 who were diagnosed with ADHD were being treated with antipsychotics such as aripiprazole, quetiapine, and risperidone.

"This study adds critical hard data to our understanding of a persistent and unacceptable trend in pediatric psychiatry," said psychiatrist Dr. Harold S. Koplewicz, the journal's editor-in-chief, in a press release. "Our poorest, most vulnerable children, lacking access to evidence-based care, are receiving potentially harmful treatment with little oversight."

According to DCF records, the antipsychotic drugs aripiprazole, olanzapine, quetiapine, and risperidone were prescribed 13,626 times to 6,837 foster children over the last five years with no diagnosis noted in FSFN.

"The use of antipsychotic drugs such as Zyprexa, Risperdal, Seroquel and Abilify to control the behavior of children displays a callous disregard for their well-being," said Dr. Breggin. "These drugs produce widespread neurological damage, including shrinkage of the brain, as well as a metabolic syndrome that includes obesity, increased cholesterol and sugar levels in the blood, hypertension, diabetes, and cardiac arrhythmias, which can be acutely fatal and also shorten the life span."

In addition to being prescribed antipsychotics, many foster children with only a diagnosis of ADHD noted in FSFN have been treated with antidepressants, which are not approved for the treatment of ADHD. ADHD-diagnosed foster children with no comorbid psychiatric diagnosis noted in FSFN have been prescribed the antidepressants Celexa (citalopram), Elavil (amitriptyline), Lexapro (escitalopram), Oleptro (trazodone), Paxil (paroxetine), Prozac (fluoxetine), Remeron (mirtazapine), Tofranil (imipramine), Wellbutrin (bupropion) and Zoloft (sertraline).

For the entire class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRI), the FDA found that, compared to placebo, these antidepressants increase the risk of suicidal thinking in children, adolescents and adults under the age of twenty-four, and required manufacturers to issue a black box warning. While the FDA warned about the link between the latest generation of antidepressants and suicidal thinking, it has since come to light that researchers conducting an influential SSRI study downplayed the fact that 17 out of 18 suicide attempts committed during the study were done by subjects exposed to the SSRI. The SSRI in the study? Fluoxetine, which as noted was one of the psychotropic drugs Gabriel Myers was taking at the time of his self-inflicted death.

Foster children with only a diagnosis of ADHD noted in FSFN were also treated with other psychotropic drugs not approved to treat ADHD, such as the mood stabilizers Depakote (valproic acid), Lamictal (lamotrigine), Tegretol (levetiracetam), and Trileptal (oxcarbazepine); as well as the antianxiety drugs Ativan (lorazepam), Buspar (buspirone), and Klonopin (clonazepam).

Dr. Phil warned Congress that "foster children may be properly diagnosed but improperly treated with medications with no scientific support for use with that particular disorder. This is especially disturbing when we have non-medication treatment techniques that are proven effective, and very importantly, do not have the long list of medication side effects."

Russian Roulette: Foster Children Still Prescribed Untested Multi-Drug Cocktails

As shocking as it may seem that five years after the death of Gabriel Myers many foster children in Florida continue to be prescribed psychotropic medications for unapproved uses, or even for no noted diagnosis in FSFN; perhaps the most troubling aspect of the psychotropic drugging of foster children in Florida revealed through DCF records is the continued prevalence of multiple drug regimens, often referred to as cocktails.

Like Gabriel Myers who was prescribed a cocktail of a mania and psychosis-inducing stimulant, a suicidal thought-provoking antidepressant, and an antipsychotic unapproved for use in children; hundreds of foster children in Florida have been prescribed untested psychotropic cocktails which can often include combinations of stimulants, antidepressants, antipsychotics, mood stabilizers and antianxiety medications.

Dr. Phil testified to Congress about the perils of prescribing multiple drug regimens to foster children: "The risks of this polypharmacy, the use of multiple drugs from multiple categories, is unfathomable. Research does not support this practice and drug-to-drug interactions potentially create more problems than they solve."

Likewise, Dr. Breggin cautioned: "Whenever you put children on multiple psychiatric drugs you are creating an experiment that is doomed to do more harm than good, and to impair the child's growth and development. There are no studies of giving multiple psychiatric drugs to children, because such studies would be unethical and result in a great deal of harm."

"We need to stop experimenting on America's children," he added.

One-Way Ticket: Aging Out Often the Only Escape for Medicated Foster Children

Florida administrative code requires prescribers to develop a plan to reduce and/or eliminate ongoing administration of psychotropic medications to foster children. Despite the existence of this requirement since March 2010, DCF only began tracking the end date of psychiatric diagnoses in FSFN beginning in November 2013.

Among the 28,909 foster children prescribed one or more psychotropic medications in the last five years, only 3,806 even had a psychiatric diagnosis noted in FSFN, and of those only eight had an end date listed for their diagnosis.

Moreover, hundreds of foster children with only a temporary diagnosis of Adjustment Disorder, a condition which according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) is only valid for up to six months after the termination of the stressor or its consequences, were prescribed psychotropic medications indefinitely.

In many cases, foster children with only a diagnosis of Adjustment Disorder noted in FSFN were prescribed stimulants, antipsychotics, and antidepressants for years on end.

Dr. Breggin commented: "That many children are prescribed psychiatric drugs for the diagnosis of Adjustment Disorder indicates the cavalier attitude of prescribers since no psychiatric drugs are approved for the treatment of Adjustment Disorders, and since by definition Adjustment Disorders are time-limited while the medications go on interminably."

While Adjustment Disorder illustrates how a temporary diagnosis can easily translate into permanent psychotropic drugging, many more foster children have been prescribed psychotropic medications for extended periods who have no psychiatric diagnosis noted in FSFN, let alone a temporary one.

Drugged Illegally: Without Informed Parental Consent or Court Order

In its findings, the GMWG cited failures of responsible parties to obtain either informed parental consent or judicial authorization for the administration of psychotropic medications to foster children. Since before the death of Gabriel Myers, Florida law has required that DCF obtain either informed parental consent or a court order prior to administering psychotropic medications to children in its care. A temporary exception is made for emergencies, but in such cases, if parental or guardian consent cannot be obtained, DCF must apply to the court for authorization within three days.

DCF records indicate that in the last five years 15,251 psychotropic medications were prescribed to 8,201 foster children without either parental or guardian consent, or court authorization noted in FSFN.

Every class of psychotropic medications has been prescribed to foster children without parental consent or a court order, including stimulants, antipsychotics, antidepressants, mood stabilizers and antianxiety drugs. In almost every case where parental consent or a court order was not noted in FSFN, there was no psychiatric diagnosis noted in FSFN either.

"Foster children are particularly vulnerable to institutional abuse," noted Dr. Breggin. "They especially need the law to be strictly followed in regard to requirements for parental or court-ordered consent to psychiatric medication."

Poor Record-Keeping Means Poor Monitoring of Psychotropic Medications

The GMWG remarked in 2009: "FSFN data are frequently incomplete and inaccurate." One of the major reasons identified for the lapse in record-keeping: "Case managers are required to enter medical information into FSFN, yet often do not understand the information and cannot verify its accuracy."

There is no doubt that record-keeping shortcomings persist to this day when tens of thousands of foster children prescribed psychotropic medications over the last five years do not even have a diagnosis noted in FSFN.

A December 8, 2011 memo from Christie Ferris, then Director of Child Welfare, sent to Regional Directors stated, “A recent review of the psychotropic medication data in FSFN found that case managers are not appropriately documenting this information in FSFN.”

Another memo sent to Regional Directors just three months later by Patricia Armstrong, then Director of Child Welfare, stated, “It is critical that information regarding the use of psychotropic medication is current and accurate as part of each child's medical history in FSFN."

"Although we have improved," Armstrong wrote, "more work remains."

While more work remains, Armstrong did not. Andrea Tulloch replaced her as Director of Child Welfare. Despite frequent rotation at the top, the message does not seem to be filtering down to the Regional Directors, or ultimately to the case workers and child protective investigators.

The GMWG also noted in 2009: "The list of psychotropic medications in FSFN, while extensive, does not include all drugs used for such purposes." According to a DCF document intended to dispel confusion among physicians regarding the use of psychotropic medications, Vyvanse and Symbyax -- the two drugs Gabriel Myers was prescribed at the time of his death -- were not included in the drop-down menu of FSFN back in 2009. Incredibly, this still appears to be the case as neither Vyvanse nor Symbyax show up as having been prescribed during the last five years.

According to an Express Scripts report, Vyvanse or lisdexamfetamine had the third highest share of the ADHD drug market in 2012, making it highly unlikely that the drug has not been prescribed to a single foster child in Florida for half of a decade. While fluoxetine and olanzapine appear separately in the FSFN drop-down, when combined in one capsule the two are referred to as Symbyax, which is also notably absent from FSFN.

That five years later the two drugs which the medical examiner could not rule out as possibly contributing to Gabriel Myers' death are not properly recorded in FSFN is almost inconceivable. But perhaps a more important question than how this could be, if it can be inferred from market data that these drugs have indeed been prescribed to foster children over the last five years, is where did these prescriptions go -- a blackhole?

The psychotropic drugs that are not included by name in the drop-down in FSFN are listed as "Other". According to DCF records, 24,850 psychotropic medications designated as "Other" have been prescribed to 6,421 foster children over the last five years. 

If drugs cannot be tracked by name in FSFN, then how could DCF quickly determine who to contact in the event of a national recall? How can DCF track whether contraindicated drugs are being prescribed concomitantly? How can DCF track which psychotropic drugs are causing serious adverse effects?     

The simple answer is they cannot, for that which is not named cannot be monitored in any meaningful way. While much of the focus has rightly been on case manager and child protective investigator data entry, or lack thereof, the GMWG also recommended back in 2009 that "[DCF] should continue refinements to [FSFN] to increase its 'user friendliness' and to reduce the number of free text and 'other' entries." Yet the problem persists five years later.

Unfortunately, the problems created by the "Other" classification do not end there. According to departmental data entry guidelines, "A general rule of thumb at present is, if a medication is listed in the FSFN dropdown box, OR if a treatment plan states a medication is for psychiatric or psychotherapeutic purposes, then it is considered psychotropic."

That means potentially tens of thousands of prescriptions for psychotropic medications with a classification of "Other" or that were ostensibly prescribed for medical purposes could be improperly excluded from the count of psychotropic medications administered to Florida's foster children. Moreover, Florida law does not distinguish between psychotropic medications prescribed for a psychotherapeutic versus a medical purpose.

To make matters worse, case workers and child protective investigators do not even adhere to the department's flawed data entry policy: 5,571 unnamed medications were prescribed to 2,780 foster children for psychotherapeutic purposes, but were not listed as psychotropic in FSFN. In most of these cases, DCF had to obtain parental consent or judicial authorization for the medications, and in many cases there is at least one psychiatric diagnosis listed in FSFN, further confirming that these medications should be counted as psychotropic.

That psychotropic prescriptions are indeed hidden behind the "Other" drug name and medical purpose loopholes is further exemplified by the fact that 4,252 foster children were prescribed 7,327 named psychotropic medications allegedly for medical purposes, even though there was at times a psychiatric diagnosis noted in FSFN. The psychotropic drugs purportedly prescribed for medical purposes include the usual suspects: stimulants, antipsychotics, antidepressants, antianxiety, and mood stabilizers. 

DCF's faulty data entry policies and practices could account for the reported precipitous decline in the percentage of foster children taking psychotropic medications to just 12 percent of the foster care population in Florida. As recently as December 2011, the Government Accountability Office (GAO), based on its review of medicaid claims for foster children in five states including Florida, reported that 20 percent of Florida's foster children were prescribed psychotropic medications.

President Obama has reportedly proposed a $750 Million budget to reduce psychotropic drugging of foster youths that would reward states for lowering their reliance on the drugs. Could DCF be under-reporting the psychotropic medications administered to foster children in order to polish its image in the wake of Gabriel Myers' death, and to better position itself for federal rewards?

Whatever turns out to be the case, it is utterly deplorable that so many prescriptions, whether psychotropic or not, remain labeled as "Other", which ultimately inhibits transparency and the proper discharge of DCF's important responsibilities to our state's foster children.

DCF records demonstrate that little, if any progress has been made regarding the administration of psychotropic medications in Florida's foster care program since Gabriel Myers' death. When will the lessons from that avoidable tragedy finally be learned? Is it going to take more deaths in foster care for DCF to make needed changes to correct the problems?

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: 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.

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