States sue over costly ADHD drug program

Florida undecided as states sue over costly drug program

By M.C. MOEWE, staff Writer

They’re powerful psychotic drugs, used to treat conditions like schizophrenia. No one knows what their effects are on children, especially infants, yet within seven years the number of children prescribed the drugs in Florida’s health insurance program for the poor has nearly doubled.

There’s no doubting one side effect, though — drug companies watched sales soar, aided by a Florida program they helped create.

Florida is far from unique. Several states also noted the costly boom of atypical antipsychotics — a new class of the drug that was touted to have fewer side effects. The states are suing drug makers, alleging the companies pushed newer, untested drugs that proved no more effective in treatments — but were far more costly.

In Florida, the taxpayers’ bill for the drugs jumped from $9 million seven years ago to nearly $30 million in 2006. Whether Florida will join states like Texas, Pennsylvania and South Carolina in trying to recoup some of those costs is unclear.

“Our office is aware of concerns with antipsychotics in Florida’s Medicaid program but we cannot acknowledge nor provide any information pertaining to ongoing criminal investigations,” said Sandi Copes, a spokeswoman with the Florida Attorney General’s office.

Florida Medicaid records show the number of children — some just months old — who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. No records for privately insured patients are available.

“The situation is out of control,” said David Cohen, a professor at Florida International University who has been studying the use of antipsychotics since 1983. While no long-term studies have been done on the effects the drugs have on children, there is evidence children on the drugs face greater risks of diabetes, hyperglycemia and extreme weight gain, Cohen said.

‘MOOD STABILIZERS’

Orange City child psychiatrist Manuel Mota-Castillo said age shouldn’t be a factor in determining whether the drug is needed. He has prescribed antipsychotics to children frequently, with the youngest being a 25-month-old child.

“I don’t want to use the name ‘antipsychotic.’ I use ‘mood stabilizer,’ ” said Mota-Castillo, who also worked for three years at Act Corp., the area’s main mental health facility.

The 25-month-old child had been kicked out of five day-care centers where complaints included punching other children, he said. “The child’s mother came to me in shorts so I could see the bruises and marks (on her),” he said.

Crystal Lamson of Sanford said Mota-Castillo has been treating her bipolar son for more than two years. Ryland, now 7, broke a Plexiglas window at a day-care center when he was 5.

“I get criticized all the time from family members,” Lamson said. “(But) there are some children out there who do need them.”

Another Sanford parent, Richard Davis, said he watched in horror as his daughter Ciara, then 6, gained 40 pounds, developed breasts and had uncontrollable tongue and facial movements.

“Those drugs were killing her,” Davis said.

Over his objections, he said Ciara was given antipsychotics by her mother and while in foster care. A court-appointed guardian also noted the effects in an August 2003 report, describing a visit in which Ciara “never once kept her tongue in her mouth.”

Ciara, now 11, was taken off the drugs after about a year, her father said, and she quickly dropped the added weight.

‘TAINTED’ MONEY

In Florida, even as drug makers were being told to issue warnings about risks, a Florida Legislature-directed program partly funded by pharmaceutical companies was recommending the drugs as treatment for attention deficit hyperactivity disorder (ADHD) with tics or intermittent explosive disorder, according to the program’s Web site that has since been shut down.

According to a study that looked at three years of data, about 40 percent of the antipsychotics prescribed to Florida Medicaid children were given to children diagnosed with ADHD — a use not approved by the Food and Drug Administration.

The Florida program was patterned after a Texas project that has spurred a whistle-blower lawsuit. The Florida Algorithm Project used some of the Texas-developed medical formulas that recommended drug treatments for mental diseases.

A year ago Texas joined the whistle-blower suit against Janssen Pharmaceutica and several other Johnson & Johnson subsidiaries. The suit alleges the program’s treatment guidelines — “improperly influenced” and paid for by the drug companies –increased sales of the antipsychotic Risperdal.

An official with Janssen said the company will defend its actions.

“We believe our participation in all aspects of our Texas Risperdal activities were in accordance with what the law required,” said Ambre Morley, a company spokeswoman.

Florida pilot programs using the Texas-developed guidelines began in 2001, according to state documents. Act Corp. in Volusia County was one of 15 sites that adopted the program until it was discontinued in September 2004.

James Bax, a former director of the Florida program, said the project began with funding from pharmaceutical companies.

“It did not take me long to realize that the money from the drug companies was tainted,” Bax said. “Once I got into it, I saw what I thought was very insidious.”

According to the program’s defunct Web site, Bax was director only a couple of months before a retired Johnson & Johnson employee took the title.

In 2002, the Florida Legislature permitted the Department of Children & Families to accept grants from pharmaceutical manufacturers to develop training for health care organizations serving public sector clients, according to a September 2003 Agency for Health Care letter about the Florida program.

When first interviewed, those familiar with the program said they did not recall any ADHD-related information. But archived pages from the program’s Internet site show the program had more guidelines on how to treat ADHD than any other ailment. A 2004 report about the program’s progress pointed to the development of an ADHD guideline as an accomplishment.

Rajive Tandon, chief psychiatrist for the Mental Health Program Office with Florida’s Department of Children & Families, said he’s not sure how much impact the Florida program had on the increased use of antipsychotics.

“It certainly was a contributing factor,” he said.

Doctors believed the new antipsychotics were better, Tandon said, citing “aggressive marketing.”

But the new antipsychotics proved no more effective than older drugs in two significant studies — one published in 2005 in the New England Journal of Medicine and another in the Journal of the American Medical Association published in 2003, said Cohen, the antipsychotics expert at Florida International.

Tandon said Florida should consider a lawsuit like other states.

“Should we at least look into it? Absolutely,” he said, calling for, at minimum, an investigation into the Florida program’s funding and impacts. “Then basically hold the appropriate people responsible.”

– News researcher Janice Cahill contributed to this report.

More Drugs

Atypical antipsychotics were touted to have fewer side effects than older antipsychotics, and their use increased among children in Florida’s Medicaid program under guidelines that drug companies helped create between 2000 and 2006.

ADHD Medications: Mayo Clinic Study Contradicts MTA Study

As I wrote earlier, the longest study actually performed while following live children was the MTA and its 3-Year Follow-up of the NIMH MTA (multi-modal treatment) recently published in the journal of the American Academy of Child and Adolescent Psychiatry.

Co-author, Professor William Pelham, of the University at Buffalo, says: “The children had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight. And the second was that there were no beneficial effects – none.”

Pelham adds, “In the short run [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Here’s the most telling observation of the study: “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.”

It’s obvious that this information was not good for the pharmaceutical industry. As is now common practice, a study will be launched to counter this kind of negative press. So, it was no surprise that the respected Mayo Clinic released a study two months later that “…reveals that compared to children without AD/HD, children with ADHD are at risk for poor long-term school outcomes such as low achievement in reading, absenteeism, repeating a grade, and dropping out of school. Both studies appear in the current edition of the Journal of Development & Behavioral Pediatrics, (http://www.jrnldbp.com).”

“In this study, treatment with stimulant medication during childhood was associated with more favorable long-term school outcomes,” explains William Barbaresi, M.D., Mayo Clinic pediatrician and lead author of the reports.

The MTA study focused on real families in real-time. The researchers were able to observe family dynamics, environment, pharmacological interventions and their relationships to academic and behavioral outcomes. This, of course, takes a significant amount of time and field researchers.

According to the Mayo Clinic Press Release, “The two Mayo Clinic studies are the first population-based, long-term studies to investigate links between ADHD, school performance and factors that modify long-term school performance of children with ADHD.”

Here’s how research like this works: researchers are given access to school files and medical records. They select and review data from files to draw their conclusions. This is becoming more popular than live research because it is less expensive, doesn’t require a significant number of field researchers, and can be done in less time. Unlike real-time research like the MTA, the Mayo study’s limitations are significant; it doesn’t allow real-time access to families or teachers to gain information regarding environment, family issues, etc; to interpret information; or to clarify written information. So the researchers are fairly limited to test scores and medical records. While this makes it easy to prepare and select data, it falls far short the information gather by a real-time study.

The Mayo study press release summarizes the research:

Dr. Barbaresi believes that both studies provide the first solid evidence of the long-term negative academic performance associated with untreated ADHD – as well as evidence for the best way to manage this problem. Dr. Barbaresi says, “The finding that treatment with stimulant medications is associated with long-term improvement in school outcomes is significant. Previously, there was evidence that treatment with stimulant medications improved short-term academic performance, but there was no good evidence that long-term outcomes are better with stimulant treatment. Our data can guide clinicians in their efforts to help children with ADHD succeed in school.”

Note that no mention is made of height and weight loss of children in the Mayo Clinic study as was found by the MTA. Furthermore it also directly contradicts information released by the MTA. Here’s the rub, funding for the Mayo study was contributed by grants from the U.S. Public Health Service; National Institutes of Health; Mayo Clinic Foundation for Biomedical Research; and McNeil Consumer and Specialty Pharmaceuticals.

Obviously the one extraordinary contributor was McNeil Consumer and Specialty Pharmaceuticals. McNeil is the producer of Concerta, a stimulant medication for ADHD. Is it likely that McNeil would contribute to a study that would indicate weight loss and stunted growth from use of its product? Not likely.

Would McNeil contribute to a study whose researchers said, “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.” Not likely.

It is a direct conflict of interest for a pharmaceutical company to participate in research with universities, hospitals, or other entities. I’ve never seen negative information released from a study performed by a pharmaceutical company on their own drug. Strange, isn’t it?

ADHD Medications and Neurofeedback

The Multimodal Treatment Study of Children With ADHD has been one of the longest studies performed on a select group of ADHD children. Recently published in the journal of the American Academy of Child and Adolescent Psychiatry, the data are somewhat alarming.

Data from the study were used to evaluate whether stimulant medication effects physical growth in children. The data collected over three years indicates that both height and weight are decreased in children using stimulant medication.

Co-author, Professor William Pelham, of the University at Buffalo, says: “The children had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight. And the second was that there were no beneficial effects – none.”

Pelham adds, “In the short run [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Here’s the most telling observation of the study: “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.”

Our good professor, Dr. Russell Barkley just spoke at a national conference citing that medication is by far the best and most trusted method. Unfortunately dinosaurs like Barkley do exist, are respected, and yet completely propagate information that has no substance in current research. Barkley is also a critic of neurofeedback.

On another front –

ADHD Drugs To Be Examined

“Two federal agencies will collaborate in the broadest study ever of prescription drugs for the treatment of attention deficit hyperactivity disorder (ADHD) and the potential for cardiovascular problems.

Over the next two years, the Agency for Healthcare Research and Quality and the Food and Drug Administration (FDA) will examine clinical data of some 500,000 adults and children who have taken such medications to determine whether they increase the risk of heart attack or stroke, the U.S. Department of Health and Human Services announced.

The FDA’s Gerald Del Pan, MD, said case reports describe “adverse cardiovascular events in adults and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether … these events are causally related to treatment.”

The study of all ADHD drugs by class will be coordinated by Vanderbilt University, with analysis by its researchers, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, plus the FDA and AHRQ, the government said.”

Curiously, this study has already been done with results published by the University of Oregon. I’ve published the results of this study before, but it was not at all favorable for ADHD drugs. Real data on long term effects, safety, comparative analysis, and general efficacy are lacking. Let’s hope the new study treats the subject with the objectivity and professionalism of the University of Oregon.

As I’ve said in past entries, I’m not a proponent of clinical neurofeedback, and I find there are limitations to some of its research, much of the research, especially research performed over the last few years, demonstrates the possibility that the brain can and will make changes provided it is given the right stimulation. Unfortunately, clinical neurofeedback training doesn’t address other core issues like organization, memory, discriminatory processing, auditory processing, time on-task, and other cognitive skills. That’s exactly why I created Play Attention. It addresses far more than clinical neurofeedback.

Probably most importantly, neither neurofeedback or Play Attention cause any stunted growth, weight loss, tics, or any side effects like medication. From our follow-up with our clients over the last eleven years, positive training effects last as well. Far unlike medication which “In the short run will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”

Medication, ADHD and Heart Complications

Long-Term Safety Questioned of Ritalin

In research published in Pediatrics, [December 2007; vol 120: pp 1494-1501], lead author, Almut G. Winterstein, PhD, assistant professor of pharmacy health care administration, University of Florida College of Pharmacy, Jacksonville, found that common stimulants used to treat attention deficit hyperactivity disorder (ADHD) don’t often cause serious heart complications in children. However, she warns that their safety is undetermined for prolonged use.

Winterstein found that stimulants such as Ritalin, Adderall, and Concerta frequently raise blood pressure and heart rate. The researchers analyzed health records from 55,000 children and teens newly diagnosed with ADHD from 1994 to 2004 with two significant findings:

  1. Children who used stimulant medication had a 20% increase in visits to hospital ERs or doctors’ offices for heart palpitations and racing heartbeat, compared with children who didn’t use stimulant medication.
  2. Stimulant medications did not appear to be associated with an increase in hospitalizations or deaths due to cardiac causes.

Last year the FDA took a special interest in the matter of heart safety when it announced a special Black Box advisory to be placed on stimulant medication. This was in part due to reports of the sudden deaths of 12 children who used ADHD Drug, Adderall.

The Canadian government quickly suspended sales of Adderall XR in Canada, but later permitted sales after further investigation.

Winterstein, PhD, in an interview with WebMD, notes:

… that because serious cardiac events are so rare among children and teens, a much larger study is needed to confirm the safety of these drugs.

“We can’t really say that there is no increase in risk (for serious cardiac events) among children who take these drugs,” she says. “What we can say is that if there is an increase in risk, it will not affect a large number of children.”

ADHD Drugs and Heart Risk

The CDC estimates that 4.4 million children between the ages of 4 and 17 have been diagnosed with ADHD, and as of 2003, 2.5 million were taking medication for it.

Children are increasingly taking the drugs for longer and longer periods, but little is known about their long-term cardiovascular impact, Winterstein says.

“The average exposure in our study was two years, but we see children who are on these drugs for five years, 10 years, and even longer,” she says.

She adds that it is also not clear if the drugs are safe for children with existing heart problems or with risk factors for heart disease.

Neurofeedback, ADHD and Medication

In his Attention Research Update, September 2007, David Rabiner, Ph.D. Senior Research Scientist, Duke University, entitled his article, How Strong is the Research Support for Neurofeedback Treatment? The report is rather perfunctory and the staid course he’s followed for years. A fresh, candid review must be performed regarding research on multi-modal treatments, neurofeedback, and medication.

Therefore, my intent here is to examine multi-modal treatments, neurofeedback, medication, their accompanying controversy and myth, and research support. I’m certain you’ll find this examination both enlightening and substantially different perceptively.

I will use some of Dr. Rabiner’s statements and also attempt to make sense of the misinformation that is propagated intentionally or unintentionally through CHADD (Children and Adults with Attention Deficit /Hyperactivity Disorder).

For the purpose of full disclosure when writing this entry:

Play Attention

I should disclose that I developed Play Attention, a device that monitors brain activity. It is used educationally to teach cognitive skills, improve attention, and shape behavior. It is not clinical neurofeedback. To be candid, I’m not a proponent of clinical neurofeedback for reasons I’ll describe below.

Dr. David Rabiner

Furthermore, it should also be disclosed that the Dr. Rabiner’s newsletter is funded by CogMed, a group that sells memory games to address ADHD, and Shire pharmaceuticals, the makers of Adderall and other ADHD medications.

Play Attention has paid Dr. Rabiner in the past to advertise in his newsletter. Dr. Rabiner also sat on the advisory board for Play Attention for several years. Play Attention can no longer advertise in Dr. Rabiner’s newsletter due to his contractual obligations with CogMed. CogMed will no longer allow Dr. Rabiner to sit on Play Attention’s advisory board either.

CHADD & Neurofeedback

CHADD is listed as a nonprofit organization, but still receives significant financial support from the pharmaceutical industry. Historically, it has done little else other than offer tips and strategies and support the use of medicine as a primary treatment.

According to Dr. Rabiner’s newsletter, CHADD’s stance on neurofeedback is summarized in their fact sheet on alternative and complementary interventions, which includes the following statement about neurofeedback:

It is important to emphasize, however, that although several studies of neurofeedback have yielded promising results, this treatment has not yet been tested in the rigorous manner that is required to make a clear conclusion about its effectiveness for AD/HD. The aforementioned studies can not be considered to have produced persuasive scientific evidence concerning the effectiveness of EEG biofeedback for ADHD.”

Well, if we hold EEG biofeedback (neurofeedback) to this “rigorous manner that is required to make a clear conclusion about its effectiveness for AD/HD,” it is only fair to hold every intervention including medication and multi-modal interventions to it as well.

Quite frankly, you’ll be surprised that they do not live up to this standard either. The actual research about medication is really no stronger than that for neurofeedback. It seems we have double talk here by an organization that receives funding from the pharmaceutical industry. Perhaps, given the benefit of the doubt, they just aren’t aware of it.

ADHD Medication Research
While it received little press in 2005, the Drug Effectiveness Review Project, based at Oregon State University released a 731-page report which thoroughly analyzed 2,287 studies – virtually every investigation ever done on ADHD drugs anywhere in the world – to reach its conclusions. To date, it is the most thorough and comprehensive evaluation of all research performed on ADHD drugs.

The American Association of Retired Persons (AARP) and Consumers Union, the publisher of Consumer Reports report the data to their respective audiences. Fourteen states other than Oregon are the principal financiers the Drug Effectiveness Review Project.

The prestigious Oregon Evidence-based Practice Center, Oregon Health & Science University Drug Effectiveness Review Project’s primary purpose is to provide consumers and state insurance plans trustworthy information about pharmaceuticals. The Drug Effectiveness Review Project’s physicians and pharmacists don’t just analyze ADHD medications, so this was not an attempt to subvert or smear that industry. They analyze virtually every study on a given class of pharmaceuticals to determine the best drugs in that class and present their findings to the public and insurance industry. The Project examined 27 drugs which included Adderall, Concerta, Cylert, Focalin, Provigil, Ritalin, Strattera, and others.

In its analysis of published and unpublished research data produced by six prominent ADHD medication producers, the group found that 2,107 studies were unreliable and were subsequently rejected. Now, this is telling in itself. Finding 2,107 funded yet critically poor or fundamentally flawed studies performed by universities and the pharmaceutical industry itself speaks volumes to the nature of that research and those people responsible for it.

The Project began its review of the remaining 180 studies which demonstrated good controls and methods. Its conclusions regarding ADHD medication were quite astounding.

Here, bulleted, are some incredible results with comments:

• “No evidence on long-term safety of drugs used to treat ADHD in young children” or adolescents. Now, if you ask any physician, or the pharmaceutical industry, they will tell you the drugs are completely safe for long-term use based on research. That research doesn’t exist.

• The research providing any evidence of safety is of “poor quality.” This includes research regarding the possibility that some ADHD drugs could cause heart or liver conditions, tics, or stunt growth.

• “Good quality evidence … is lacking” that ADHD drugs demonstrate improvement in “global academic performance, consequences of risky behaviors, social achievements,” and other measures. The common perception is that ADHD drugs do improve academic performance and social skills. Many drug makers use ads depicting this. However, evidence for long-term improvement in academics, social skills, or behavior is virtually non-existent.

• Drug makers have found that they can expand their market by inducing adults into the ADHD experience. However, the Project found that evidence “is not compelling” demonstrating that ADHD drugs actually help adults, nor is there evidence that one drug “is more tolerable than another.”

Furthermore, the Project found that the U.S. Food and Drug Administration doesn’t require pharmaceutical manufacturers to compare newly developed medications with medications currently on the shelf. Most companies simply use a placebo or sugar pill given instead of their medication as a control. Therefore the Project found that “good quality” studies are lacking that pit one drug against another to provide evidence of effectiveness. It also could not find comparative data which might help determine which ADHD medications are less likely to produce detrimental side effects like heart and liver problems, depression, decreased appetite, tics, or seizures.

The Project could not find research that clearly provided an understanding of way that ADHD drugs work. It is not well understood for most ADHD drugs.

Even the research on ADHD performed by the respected Dr. Russell Barkley, a critic of neurofeedback studies, ranked only “fair” in the Project’s analysis of research and he’s had significant funding from the pharmaceutical industry, federal government, and universities. Noting that he’s cited most neurofeedback research as lacking, wouldn’t we expect at least a “good” or even a “superior” on his report card?

So, if one chooses ADHD medication, how does one know which drug is safer? Works better? Has fewer side effects? The research isn’t there, so we don’t know. In light of this, the Project suggested that one may do just as well on methylphenidate (generic Ritalin) which is far less expensive than newer options such as Concerta or Adderall. Incidentally, when the Project reviewed research on Concerta, it concluded that Concerta “did not show overall difference in outcomes” compared to generic good old cheap generic methylphenidate. Is Adderall any better? The Project found evidence to be “lacking.”

Do ADHD drugs provide long-term improvement for academic performance? Social interaction? Better behavior? The research just isn’t there.

The Project made clear that its findings do not mean ADHD drugs are unsafe. They may be safe and sometimes useful, but the Project found scientific proof is lacking.

While I’m not a clinical neurofeedback proponent, I think it’s clear that if pundits like Dr. Rabiner and organizations like CHADD are going to talk about good research, then let’s level the playing field and have the same requirements for everyone.

Standards of Research, Dr. Rabiner, & CHADD

Let’s go back to CHADD for a moment and its warnings about neurofeedback.

“Controlled randomized trials are required before conclusions can be reached. Until then, buyers should beware of the limitations in the published science. Parents are advised to proceed cautiously as it can be expensive – a typical course of neurofeedback treatment may require 40 or more sessions – and because other AD/HD treatments (i.e., multi-modal treatment) currently enjoy substantially greater research support.

Now, let’s examine the 3-Year Follow-up of the NIMH MTA (multi-modal treatment) Study. CHADD states studies such as this most recent one and most thorough one “enjoy substantially greater research support.” :

According to Dr. Rabiner, neurofeedback studies, while often producing good results, often lack random assignment. Here’s what he states in his current newsletter:

    Random Assignment

    Imagine that you are testing a new medication treatment for ADHD with 50 children who have been carefully diagnosed. In a random assignment study, whether each child is assigned to the treatment or control condition is determined by chance – you could flip a coin and give the medicine to the ‘heads’ and nothing to the ‘tails’. This insures that any differences that might exist between children who get the medication and those who don’t are purely chance differences. At the end of the study, if those who received the medicine are doing better, you could feel confident that this is probably due to the medicine itself, and not to differences that may have been there before the treatment even started.

    What if you didn’t use random assignment, but let each child’s parents choose whether their child is in the treatment or control group? In this case, it is possible that children in the 2 groups differed in important ways before the treatment began. If children who received the medication were doing better at the end of the study, it might be because of differences that were there to start with.

    For example, parents who chose the medicine might be more willing to pursue other ways to help their child than those who didn’t. The fact that children who received the medication were doing better at the end of the study might thus have nothing to do with the medicine itself, but reflect other things their parents were doing to help them. No matter how hard you might try to rule out these other possible explanations – and I’m sure you can think of many others – you could never do this with certainty. Thus, I might reasonably doubt that your new medication is really effective.

National Institutes of Mental Health Multi-Modal Treatment Study

But if Dr. Rabiner is correct that research without random assignment is ambiguous, possibly not valid, then let’s try to evaluate data from the 3-Year Follow-up of the NIMH MTA (Multi-Modal Treatment) Study. Let’s look at the researchers said about the 14th month:

    Indeed, once the delivery of randomly assigned treatments by MTA staff stopped at 14 months, the MTA became an observational study in which subjects and families were free to choose their own treatment but in the context of availability and barriers to care existing in their communities.

So what are we to gain from the long-term evaluation done in the MTA study? Does it enjoy substantially greater research support? According to Dr. Rabiner’s standards, not if it became an observational study.

CHADD also warns that neurofeedback is expensive. How expensive is it compared to ongoing medication for a lifetime? We’ll that’s relative isn’t it? How expensive is medication to a single mom with no insurance? Heck, to any parent with or without insurance? To grandparents raising their grandchild in mom’s absence? And by taking medication, which is expensive (Concerta, AdderallXR), etc, are we guaranteed anything more than what neurofeedback might offer? According to available research, No. CHADD’s arguments lack substance but have been their common response for a long time. I am asking that this nonsense ends.

Neurofeedback

Back to neurofeedback…The primary purpose of neurofeedback is to alter brainwave patterns that are presented in real-time feedback to clients. Clients [Rabiner] “…are trained to alter their brainwave activity and taught to alter their typical EEG pattern to one that is consistent with a focused and attentive state. According to neurofeedback proponents, when this occurs, improved attention and reduced hyperactive/impulsive behavior will result.”

Thus, the fundamental premise behind neurofeedback is that brainwaves are dysregulated, especially in certain areas of the brain, and training can regulate them. Furthermore, it is proposed that this regulation improves attention and behaviors. I find this to be rather facile. Neurofeedback’s premise is surprisingly similar to medication in essence; fix these brainwaves and the person is fixed whereas proponents of drug intervention insist that if one takes a pill ADHD is fixed! Unfortunately, neither of these therapies adequately fully addresses core issues of ADHD. Neither medication or neurofeedback, by themselves teach the skills one needs to survive and thrive in the workplace or classroom. Skills like organization, improved memory, discriminatory processing, auditory processing, time-on-task, etc. are not trained through either of these interventions. The only way to attain them is to train and learn them.

I’m not saying that neurofeedback doesn’t work. It’s been field tested as has been medication for years. Could it be a worthwhile tool to be used in a multi-modal plan? Yes. Again, let’s level the playing field.

Current Neuroscience & Neuroplasticity vs. Current ADHD Interventions

The reality about neurobehavioral problems is that they exist in a context, i.e. they exist because of the brain and because of that brain’s environment. The brain is directly affected by its environment. The brain is neuroplastic; it will and does adapt according to the stimulation it receives. That is conclusive fact. No doubt about it. So, if we are speaking about a human being, then attention problems are not just brain based. They may take root there, but they are also directly related to and affected by one’s environment. Therefore, appropriate environmental factors play a great role in the treatment of ADHD including behavior shaping, consistent reward/consequences, structure, etc.

The fact that our current system doesn’t address this fact is where we fall far short of correctly treating ADHD.

Let’s say that little Jimmy demonstrates some fidgeting and inattention at school. His teacher writes a note home telling Jimmy’s parents she suspects Jimmy may have ADHD. Jimmy’s parents take heed and bring him to the pediatrician where Jimmy gets a prescription for medication within 20 minutes. This is the norm.

What’s sorely missing is where Jimmy’s parents or Jimmy’s pediatrician write a note back asking to speak to the teacher to develop a plan of action regarding Jimmy’s behavior before beginning medication. This should be our standard practice regarding ADHD. We need to change the way we view ADHD and the way we address ADHD according to current neuroscience, not how we addressed it in 1980.

Unfortunately, most pediatricians or general practitioners are quite overwhelmed and not well equipped educationally to provide a full battery of tests taking up to four or five hours for an accurate diagnosis. So, a reverse diagnosis is made; the MD writes the prescription for medication and if it works, it was ADHD!

The problem is that stimulant medication works for everyone. If we have two groups of children, one group diagnosed with ADHD and one group of average children, both given boring tasks, both medicated, who will do better on the boring tasks? The answer is: Both! Medication is a shotgun approach that teaches nothing. Virtually no research demonstrates long-term efficacy in social improvement, academic improvement, or behavioral improvement.

Attention is a skill like any other skill. It can be considered a cognitive skill that is measured by behavioral or performance analysis. Should strategies, known to work to improve performance on ADHD students be attempted before medication or neurofeedback? Yes. Resoundingly yes! Should Jimmy’s parents adopt a structured, consistent schedule at home? Yes. Should Jimmy’s parents develop a behavioral plan for school and home working together with Jimmy’s teacher? Yes. Should all of this be employed before neurofeedback and medication? Yes. Could it be employed while using either medication or neurofeedback? Yes. Is it far less expensive than these other interventions? Yes.

Why don’t we do this first then? While a variety of factors relate to the answer, one of the most significant ones is: It is easier to take a pill or to ask someone else to solve your problem than it is to do the work to solve it yourself. Granted, many parents are not trained to work with ADHD children, but they can learn and need to – it’s part of being a parent.

I’ll quote the respected psychologist, Dr. Abraham Maslow –

If the only tool you have is a hammer, you tend to see every problem as a nail.

Here’s how this quote relates to our current dilemma: Many parents rely on their Doctor’s opinion alone believing the physician is almost all knowing. Doctors, pediatricians included, are sparsely trained to instruct parents or educators on how to facilitate a multi-modal management plan. Instead, as they are instructed from medical school and because medicals schools rely heavily on pharmaceutical money, they are given the only answer: drugs. It is only natural that parents believe this. Unfortunately, neither the medical industry, pundits, or CHADD are familiar with research regarding medication or either choose to ignore it.

Neurofeedback Controversy

Back to Dr. Rabiner’s newsletter, this segment entitled, Controversy Surrounding Neurofeedback Research.

Neurofeedback treatment for ADHD has been a source of substantial controversy in the field for many years and remains so today. Although there are a number of published studies in which positive results have been reported, many prominent ADHD researchers feel that given significant limitations to the design and implementation of these studies, neurofeedback should be considered a promising, but unproven treatment.

I think it’s quite reasonable to say that the ‘controversy’ surrounding neurofeedback is constantly stirred up by articles such as Dr. Rabiner’s. He also says that neurofeedback studies sometimes suffer from smaller populations, etc. It does make good press, but given significant limitations to the design and implementation of studies on multi-modal treatments and pharmaceuticals, they should all be considered promising, but unproven treatments. Neurofeedback research seems to suffer the same dilemma as that of multi-modal and pharmaceutical interventions – all could be far stronger. All have considerable weaknesses. All have some strengths because they’ve been field tested for many years. So, either they are all controversial, or none of them is controversial. It’s far past time to stop double talking.

Summary

Neither medication nor neurofeedback are solutions unto themselves.

Without hidden agendas or profit motives they are on the same playing field. Now, let’s play fair and develop strategies based on our knowledge of the ADHD problem. It’s in the best interest of our children and their outcomes to find workable, manageable solutions.

Obviously, no one intervention is best, proven, or more reliable even if marketing people would like to make it seem so. It takes a whole village to raise a child. It takes a group of interventions to raise an ADHD child. Let’s find the best interventions, based on honest available research, use them in concert, and see if it works. And understand this caveat clearly, just because research, no matter how high a grade it’s given, demonstrates efficacy, it doesn’t mean that it will work successfully for you or your child. That’s just because we’re human. We learn differently, respond differently, and are wired differently based on our years of exposure to the world and our genetic makeup. That’s not theory. That’s fact.

Given that no intervention is sufficient by itself, it will always be a matter of trail and error to determine what course of actions will succeed for the long-term. Even though we desire or wish it, none are guaranteed, but that’s life, isn’t it?

The Evolution of ADHD, Education, and Drugs in America – Part 5

Note: I’ve lectured on this subject for over 10 years. This will be the first time I’ve placed my collective thoughts into print. I’ll present the topic as a series of essays.

Sigmund Freud vs. Dennis the Menace

As I mentioned previously, many factors were involved in the cultural shift that altered our perception about children like Dennis the Menace. The cultural shift has made the United States the leading consumer of Ritalin. As a matter of fact, according to the International Narcotics Control Board (INCB), the US now consumes about 90% of the world’s Ritalin supply!

The cultural shift was gradual, but what made us change perception to the point where we consider children like Dennis to have a neurological disorder? To put it plainly, we now consider Dennis to have a problem with his brain. Who would have thought that possible? Well, psychiatrists, actually.

Sigmund Freud, famed Austrian neurologist and psychiatrist who co-founded the psychoanalytic school of psychology was perhaps best known for the theory of the unconscious mind. He proposed that the mind was multi-layered and that these layers could cause physical problems. The notion that the mind possessed a subconscious element was not new. Psychologist William James and colleagues had written about it years before, but it was Freud who advanced the concept by proposing that the subconscious could be systematically studied through psychoanalysis.

For years prior to Freud’s contributions, especially during the 19th century, French sociologist, Auguste Comte’s positivism was favored. Positivists believed that one could come to true understanding of oneself through scientific study and discipline. In other words, one could control oneself and one’s environment through free-will. Freud countered that free will was not possible because we have a subconscious of which we are totally unaware and often act for reasons that are unrelated to our conscious thoughts. These “repressed” thoughts were often directed toward one’s parents; however, individuals could repress different things as well.

Freud’s theory, although greatly altered one way or another, permeated medical practice as it was taught at many medical schools. Universities began to teach it, and it eventually took hold in public education by the 1950s. Even before that time, in mid 1940s, Dr. Benjamin Spock had devised a child rearing philosophy based more on Freud’s theory than on the popular behaviorist model of the time. Spock emphasized the need for parents to understand and treat each child as an individual and to understand their particular needs. Detractors generally cited Spock’s work as “overly permissive” and government spokes people cited him for creating much of the turmoil of the 1960s. But that’s an entire blog unto itself. Point of fact is that as a culture, we understood, disciplined, and dealt with children based on nurturing. If a child had a problem, it was caused by his upbringing. Furthermore, it was thought that the problem could be corrected by nurturing the child and changing the child’s environment, through understanding the child’s needs.

This changed radically in 1980 with the release of the Diagnostic and Statistical Manual III (DSM III).


The other articles in the series “The Evolution of ADHD, Education, and Drugs in America” can be found below.

  1. Dennis the Menace
  2. Henry Ford and Education
  3. Henry Ford vs. Dennis the Menace
  4. Soviet Menace vs. Dennis the Menace
  5. Sigmund Freud vs. Dennis the Menace

he Evolution of ADHD, Education, and Drugs in America – Part 4

Note: I’ve lectured on this subject for over 10 years. This will be the first time I’ve placed my collective thoughts into print. I’ll present the topic as a series of essays.

The Soviet Menace vs. Dennis the Menace

In the late 1950s, when Dennis the Menace was just beginning to annoy his neighbor, Mr. Wilson, certain dynamics would once again change the face of education; our nemesis, the Soviet Union, launched Sputnik. The Soviet Sputnik program involved the launch of a series of man-made satellites after testing their viability through unmanned space vehicles. The cold-war fear of the Soviet Union and their possible nuclear superiority also led to the creation of NASA.

Sputnik prompted the U.S. government to increase spending on scientific research and education. This led to the National Defense Education Act (NDEA). The NDEA provided federal money for increased instruction in math & science, as well as foreign language. Another important feature of the NDEA was the forgiveness of loans for higher education; educational expenses for prospective elementary and secondary teachers could be waived. The thrust of the NDEA also reasserted emphasis on academic fundamentals like reading, writing, and arithmetic.

So, now children in the Henry Ford production line model of education, tempered by John Dewey’s experiential, nurturing educational philosophy, were exposed to changes to curriculum based on society’s fear of satellites. Strangely enough, even with the crazy dynamics of the times, children with attention problems existed; however, they were viewed quite differently than today’s ADHD children and actually survived and thrived quite well. Nurturing was expected and practiced at school, boundaries were set and maintained; if you got in trouble at school, you were likely to be in twice as much trouble when you got home. Furthermore, without the demands of incredibly stringent testing in all grades, ADHD children could were not exposed to the demands currently place on them.

But this would change within a decade or so. Due to the emphasis on science and math, curriculum began to be pushed downward. What was once taught at first year university was now being pushed to junior and senior years in high school. Junior and senior high curriculums were pushed downward as well. Over the years, this chain of curriculum change found its way all down to kindergarten. More tests were now needed to assess whether the curriculum changes initiated by both federal and state mandates were making our children smarter and more competitive with the rest of the world.

Another dynamic was causing social change. With an ensuing space race and advancing technology, a new core value system was in play; happiness comes through owning material things like new technology or the next best automobile. To get more things and therefore be happy, one had to make more money. To make more money one had to pursue higher education. To get the opportunity to pursue higher education, make more money, and be happy, one had to perform better at school.

I won’t argue philosophically about material goods bringing happiness, but most research indicates this is not so. What’s important to note here is that we have a definite class system in place; those who perform well at school have access to higher education and happiness, and those who are cast out of higher education to go to technical or trade schools, make less money and are less happy. That’s the perception, anyway.


The other articles in the series “The Evolution of ADHD, Education, and Drugs in America” can be found below.

  1. Dennis the Menace
  2. Henry Ford and Education
  3. Henry Ford vs. Dennis the Menace
  4. Soviet Menace vs. Dennis the Menace
  5. Sigmund Freud vs. Dennis the Menace

The Evolution of ADHD, Education, and Drugs in America – Part 3

Note: I’ve lectured on this subject for over 10 years. This will be the first time I’ve placed my collective thoughts into print. I’ll present the topic as a series of essays.

Henry Ford vs. Dennis the Menace

Dennis the Menace began appearing as a comic strip character in the early 1950s. While his physical appearance changed slightly in the 1960s and 1970s, he was still considered a lovable child when I began my teaching career in the mid 1980s. We continued to laugh at his innocent acts of menace toward his family and friends without mention of medication or ADHD.

When I met my Dennis, or John, in the late 1980s, I was astonished that he was viewed by the other staff as ‘uncontrollable’ and ‘unteachable.’ He was considered a problem child. John was a square peg trying to fit in the round hole of an educational machine. The educational world had less tolerance for children like John, and ADHD was about to was about vastly change education – not necessarily for the better.

What had in fact affected John in the 1980s had its roots in much earlier times. A confluence of events was actually creating the perfect storm for the Ritalin revolution. Change was underway in education, mental health, and medicine that produced an enormous shift in American culture. This shift would greatly affect John and all children like him.

Dennis the Menace was not yet created in the early 1930s when Henry Ford’s efficient production line model was adopted into public education. In mass fashion, children were taught in classrooms with rows, using state issued textbooks, aggregately reciting the pledge of allegiance, and instructed at the same pace with the same curriculum by the same teacher. We now had efficient education for the masses.

This model was somewhat tempered by philosopher John Dewey. Dewey received his Ph.D from the School of Arts & Sciences at Johns Hopkins University in 1884. However, his theoretical basis for his Pragmatic school of thought was developed during his tenure at the newly founded University of Chicago beginning in 1899. The Pragmatic school of thought embraced an empirically based theory of knowledge which was further refined at the University of Chicago Laboratory Schools. Dewey developed his ideas for education based on his work at the Laboratory Schools and published Experience and Education in 1938 after many other books. Dewey emphasized a humanistic approach to education where development of problem solving and critical thinking skills were fundamental and paramount to increasing intellect. This contradicted the traditional practice of rote memorization. His philosophy of education also embraced individualization and accounted for the needs and differences among students. This was based upon Dewey’s vision that while a student is a small part of society, they student will in turn strengthen democratic society if he is a critical thinker and problem solver. This is analogous to the pilings in a bride; the stronger the pilings, the stronger the bridge.

While Dewey’s pedagogy was not officially adopted by schools, his influence affected national education for a long period and created an environment where nurturing and experience played important roles in rearing children. This would soon change.


The other articles in the series “The Evolution of ADHD, Education, and Drugs in America” can be found below.

  1. Dennis the Menace
  2. Henry Ford and Education
  3. Henry Ford vs. Dennis the Menace
  4. Soviet Menace vs. Dennis the Menace
  5. Sigmund Freud vs. Dennis the Menace

The Evolution of ADHD, Education, and Drugs in America – Part 2

Note: I’ve lectured on this subject for over 10 years. This will be the first time I’ve placed my collective thoughts into print. I’ll present the topic as a series of essays.

Henry Ford and Education

The great industrialist and inventor, Henry Ford founded his company on precision and efficiency in the early 1900s. To produce cars for the masses, he would need a method of assembly that could quickly assemble mass produced parts into a complete automobile. His assembly line model rapidly changed the world. Using the assembly/production line model, mass assembly of products became the norm. This in turn produced higher volumes of products available to the masses. Mass production allowed manufacturers to sell products for cheaper prices as well. All of this was based on efficiency. Educationalists were impressed.

Prior to the early 20th century and the assembly line, manufacture was performed by a single craftsman or team of craftsmen. Known as the English System, craftsmen typically would produce each part of a product individually. In the final phase of production, the craftsmen would assemble the components together into a single product. At that time, if changes were needed to the individual parts, the craftsmen would modify the parts to make them fit or work together. While this process was slow and did not produce mass quantities of goods, it produced high quality goods with attention to detail. This practice was similar to our method of teaching in rural one-room school houses where students sat together on benches.

If we envision a student as a basic raw component, like a car chassis, and following the production line model, we could get his wheels on by the end of kindergarten. In first grade we insert the engine. In second grade we put in the brakes. In fourth grade we put on the body. Thus, by the end of high school, we should have a completed student or car as it were.

There would be a need then, to make this process efficient. There would be no more need for small school houses. Big schools would be built where large numbers of students could be housed. Mass transportation would have to be implemented to ensure that large numbers of students could be assembled in the larger schools. Students should sit in rows as this would make it more efficient for the teacher when handing out mass produced work sheets and tests. There would be no need for individualized instruction when a generalized curriculum would fit. By senior year in high school, those students not prepared to move on to higher education (defective parts) can be diverted to technical schools to prepare them for work in the service industry.

And that’s what we did in the early 1900s.


The other articles in the series “The Evolution of ADHD, Education, and Drugs in America” can be found below.

  1. Dennis the Menace
  2. Henry Ford and Education
  3. Henry Ford vs. Dennis the Menace
  4. Soviet Menace vs. Dennis the Menace
  5. Sigmund Freud vs. Dennis the Menace

The Evolution of ADHD, Education, and Drugs in America – Part 1

Note: I’ve lectured on this subject for over 10 years. This will be the first time I’ve placed my collective thoughts into print. I’ll present the topic as a series of essays.

Dennis the Menace

Anyone remember Dennis the Menace? As a child, I watched Jay North portray that mischievous blond-headed boy who always got into trouble and annoyed his grumpy neighbor. Dennis was loved back then.

Dennis is the kid everyone seems to have on his street even now. He’s intelligent and uses it to get into everything. Even when he tries to help others out, he still finds trouble. He often acts out without thinking about consequences.

I taught ‘Dennis’ during my second year as a classroom teacher in the North Carolina school system in the mid 1980s. His real name was John. John was the type of boy that the other teachers called ‘hellion’ in hushed whisper in the faculty lounge. The other teachers told me that, “He won’t do anything. Tie a carrot to the end of a stick; he’ll play with it all year.” Instead of being that character we all loved, ‘Dennis’ was medicated.

Being a progressive teacher and not having become cynical, I was determined to save John. Since I had learned nothing at university about unfocused, hyperactive children, I consulted my professors. They advised me to move John closer to my desk; set up an individualized education plan (IEP) that included modifications to John’s curriculum, shortened assignments and instructions; and a daily checklist with rewards.

I followed their instructions implicitly. John sat right next to my desk. The modifications to his curriculum quickly began to change John’s self-esteem. We got work done everyday and his math and reading ability began to improve. His parents, however, only had eighth grade educations. They failed to return John’s checklist after a couple of days. They also didn’t have the skills to provide positive reinforcement at home. To my dismay, John’s father began to hit him with a leather belt. Corporal punishment was still used at school, so this wasn’t unusual, even though I didn’t approve.

A few days later, John came in and placed his forehead on his desk behind folded arms.

No more than three feet from my right hand, I nudged him and said, “Didn’t you get enough sleep last night?”

He looked up at me without the mischievous twinkle, his eyes a little bloodshot. He pushed a folded note at me across my desk. “Medicine,” he said.

The note was from John’s family doctor. It was actually a checklist for me to complete that would assist the doctor in determining dosage. I completed 4 checklists without seeing much change in John’s groggy demeanor. The hellion was gone, his spark was gone, but he was manageable at home. At least John’s father wasn’t beating him anymore.


The other articles in the series “The Evolution of ADHD, Education, and Drugs in America” can be found below.

  1. Dennis the Menace
  2. Henry Ford and Education
  3. Henry Ford vs. Dennis the Menace
  4. Soviet Menace vs. Dennis the Menace
  5. Sigmund Freud vs. Dennis the Menace