Conflicts of Interest in children's psychotropic clinical trials

via The Alliance for Human Research Protection:

Conflicts of Interest in Clinical Trials
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department
and The Henry M. Jackson Foundation for the Advancement of Military Medicine
May 5-7, 2002

Case 7: Children exposed to risks in psychotropic drug trials:

Psychotropic drugs are being tested in children despite the acknowledged risks of harm. Psychotropic drugs are advertised as normalizing a "chemical imbalance" in the brain. In fact, they do the opposite: they induce profound changes in the central nervous system with demonstrable physical and neurological impairments.[48] Dr. Steven Hyman, former director of NIMH, an expert on the mechanisms by which psychoactive drugs work, explained that, whether abused or prescribed, the mechanisms by which psychoactive drugs work are the same.[49] Hyman stated that antidepressants, psychostimulants, and anti-psychotics created "perturbations in neurotransmitter function."[50] The drugs' severe adverse side effects are symptoms of the drugs' disruptive effect on the neurotransmitter system and on brain function.

In 2001 Dr. Benedetto Vitiello, NIMH's director of Child and Adolescent Treatment and Preventive Interventions Branch acknowledged the impact of FDAMA: "pediatric psychopharmacology has recently seen an unprecedented expansion clinical trials in youths has more than doubled in the last few years."[51] Indeed, children as young as three are being recruited to test mind-altering drugs that may affect their developing brain. Parents are being offered financial inducements to volunteer their children for drug trials. The foremost problem with prescribing or testing psychotropic drugs for children is the absence of any objective criteria for diagnosing children with pathological behavioral problems to justify pharmacologic intervention. Vitiello acknowledged "diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood."[52] Vitiello also acknowledged the possibility of long-term harm: "The impact of psychotropics on the developing brain is largely unknown, and possible long-term effects of early exposure to these drugs have not been investigated."

Eli Lilly's highly touted new anti-psychotic, Zyprexa,[53] reveals much about the collision between corporate interests and the health and safety of children. In clinical trials averaging 6 weeks, Zyprexa was tested in 2,500 adults. The drug was linked to serious, in some cases life-threatening side effects requiring hospitalization in 22% of those tested.[24]Acute weight gain of 50 to 70 lbs is usual, and with it the increased risk of diabetes. FDA data (under FOIA) reveals a 65% drop out rate, and only 26% favorable response. During those 6 week clinical trials there were 20 deaths, of which 12 were suicides.[54] David Healy, who found a suicidal link to antidepressants (Selective Serotonin Re-uptake Inhibitors) in his research says, as far as he can establish, the data from these trials "demonstrate a higher death rate on Zyprexa than on any other antipsychotic ever recorded." [55] In 2000, FDA approved Zyprexa for short- term use only, in bi-polar patients. [56]

Yet, children aged six to eleven were recruited for clinical trials to test the drug. According to their published report, UCLA investigators tested Zyprexa on children who were not even diagnosed as having schizophrenia. The children were diagnosed as having a variety of questionable psychiatric disorders, including ADHD.[57] According to the published report, all the children in the trial experienced adverse effects, including sedation, acute weight gain, and akathisia (restless agitation). The trial was terminated less than six weeks after it had begun.

Controversy surrounds a Zyprexa trial at Yale University. In that experiment, 31 youngsters aged 12 to 25 who have not been diagnosed with any psychiatric illness are being exposed to the drug for one year. The stated rationale given by the researchers (who are under contract with the sponsor) is their speculation that these children may be "at risk" for schizophrenia. Since there are, as yet, no objective tests or biological markers for the illness - they hypothesize without evidence, merely on the basis of conjecture. The shaky basis for their conjecture is that assumption that the children may develop schizophrenia because one of their siblings has been diagnosed with the disorder.

The risk of schizophrenia for the general population is 1%. For siblings the risk increases from 2% to 15% - in other words there is 85% likelihood that these children will never develop schizophrenia.

Given the absence of scientifically accurate tools for interpreting psychiatric symptoms, psychiatrists cannot as yet accurately diagnose schizophrenia much less predict which children will get it. Is it ethical to expose healthy children to risks of drug- induced pathology on such speculation? The Wall Street Journal aptly noted that such a study "raises the question of whether the drug companies are mainly interested in "creating" a new illness that requires drug treatment." Read the entire report here

via Alliance for Human Research Protection:

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, including an antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.

Write to David Armstrong at david.armstrong@wsj.com

Printed in The Wall Street Journal, page B1 Complete article here
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

via National Association  of Medicaid Directors 2012 Fall Conference:

The Problem

• MH conditions account for large share of overall illness burden and expenditure -- directly and via impact on treatment and course of co-occurring medical conditions.  

• For publicly insured, responsibility for and data on MH tx often fragmented between multiple systems; care processes and outcomes often fall short. Prescription pad often easier to access than appropriate, coordinated, evidence-based services. 

• Appropriate, safe and effective use of antipsychotic (AP) and other psychotropic medications identified by states and other stakeholders as high-priority QI issue.  High rates of off-label AP use, often without adequate psychosocial mental health services, are a concern.  

• Use patterns vary widely; uptake of evidence based practices highly uneven.  Need for more effective monitoring and management of these powerful but not risk-free treatments.

• Recent developments such as GAO report on prescribing in foster care and IG report on prescribing in nursing homes reinforce the need.

• States need tools to address these needs.Key Concerns

• Within-class and between-class polypharmacy; dosage; use in children under 6:  “too many, too young, too much.”

• High psychotropic use and polypharmacy in foster youth.

• Use in nursing home (and community) elderly with dementia, despite significant safety concerns and FDA black box warning.  

• New national concerns sparked by GAO reports on psychotropics in foster youth, and IG report on antipsychotics in nursing home elderly.  New ACYF requirements for foster youth; CMS goal of reduction in AP use in nursing homes.

• Monitoring and managing metabolic risks of antipsychotics.

• Monitoring and improving adherence (adult quality measure on consistent use of AP meds in benes with schizophrenia is a good place to start).

• MH assessment and services consistent with treatment.

• Inconsistent access to some treatments (e.g., evidence-based psychosocial interventions, trauma-informed treatments, clozapine).

Informed Consent protocol for foster kids in Washington State protects the State. Let's be real, who in their right mind would believe that it is in the "best interests" of children and teenagers in the care and custody of Washington State to have no adult/advocate to give Informed Consent for medical care? Adolescents who want and need mental health and/or substance abuse treatment should get it, regardless of familial support or familial status; pretending that kids are physically/emotionally adult enough to legally give Informed Consent BUT ONLY for psychiatric diagnoses, including alcoholism and drug addiction is unethical to say the least...morally reprehensible really. Human brains are not fully mature until the early twenties. In reality, the State of Washington  "legally" placed foster kids in harm's way by relying on a profession with a history of dishonesty, abuse of authority and abuse of "Medical" privilege. As a society, we have in effect deprived of one of the safeguards which may protect them from iatrogenic injury, or worse...

TMAP is considered a "Best Practice"

Primum non nocere 

Declare the past, diagnose the present, foretell the future; practice these acts. 

As to diseases, make a habit of two things to help, or at least to do no harm. 

A doctor who thinks TMAP is a "Best Practice," isn't much of a doctor...

Jeffrey Thompson, M.D. Medical Director, Washington State Department of Social and Health Services, testifying in a HEARING before the SUBCOMMITTEE ON INCOME SECURITY AND FAMILY SUPPORT of the COMMITTEE ON WAYS AND MEANS U.S. HOUSE OF REPRESENTATIVES MAY 8, 2008 on PRESCRIPTION PSYCHOTROPIC DRUG USE AMONG CHILDREN IN FOSTER CARE

A few excerpts:

"We note that the data is presented in a non-judgmental manner. This brings the Committee together, and I might add, the drug companies are actually at the table when we discuss this. What we want to do is stop and take a short, deep breath and review the treatment plans to ensure that there's an integrated plan for the treatment. (emphasis mine)

 
"Recently, our safety standards for stimulants have steered as many as 56 percent of prescriptions for stimulants to lower dose, fewer medications, and sometimes to rethink prescriptions in the very young. Note that 44 percent of prescriptions that are at high dose are in the very young, when our community and us agree that this is actually the appropriate use. (emphasis mine)

"When we look across the country we see antipsychotic use that varies between states--as much as 4% to 13% in the Medicaid populations. Because there is so much variation, the Medicaid medical directors asked NASMD and AHRQ to sponsor an up-to-date pharmacy claims and program bench marking project. We hope this bench marking will highlight "best practices'' like the Texas algorithims..." (emphasis mine) here 

Those Texas algorithms, known as TMAP is a marketing strategy that is used to sell the newest most expensive psychotropic drugs; TMAP was never a "best practice" it was always simply a fraudulent marketing strategy with patently false claims that the  preferred drugs on what Jeffery Thompson called, "the Texas algorithms" were safer and more effective than the older ones; justifying their high cost. TMAP algorithms played a critical role in  the massive amount of Medicaid fraud.  Apparently, here in Washington State it still does.    

I am having difficulty wrapping my mind around the idea that 44% of psychotropic drugs being  prescribed in high doses are being given to the very young here in Washington State. This is, according to Jeffery Thompson's testimony, "the appropriate use" for the drugs. He's obviously working closely with (or is it for?) the drug companies.  So very unethical for Washington's Medicaid Director to have characterized TMAP as a "best practice;" Allen Jones had filed a Federal Whistle-blower Lawsuit in 2004, the State of Texas joined it in 2006. In 2008, when Jeffery Thompson called "the Texas algorithms" a "best practice," it was well known that TMAP was simply an unethical marketing scheme. 

This is the same Director who issued an "emergency warning" for Methadone AFTER 2,173 deaths had become public knowledge.

Washington State hired an architect of the TMAP fraud

What's an emergency?

"emergency warning" issued after 2,173 deaths

In May of 2004 Washington State's preferred drug list took effect the only preferred drugs on it for long term chronic pain were methadone and morphine.  For years afterwards the rising death toll was a topic of discussion and debate at the monthly Pharmacy and Therapeutics Committee meetings without any definitive corrective action being taken.


Two years and nine months after the Feb. 18, 2009 meeting of the P&;T committee, during which it was stated that the deaths due to methadone overdose were continuing to occur; it was also stated that this 'issue' had been a regular topic for 3-4 years by then.  AFTER the death toll was publicized by the Seattle Times on December 10, 2011, the State of Washington's Medicaid program announced that it was issuing an EMERGENCY WARNING---Issuing a warning after two thousand people have died, is kind of like teaching your child about fire after they have burned your house down playing with matches... 

Strictly speaking, issuing a warning years after the State P&T committee members were aware, (and after over 2,000 deaths!) is not really much of a warning...it's obvious the situation wasn't considered an EMERGENCY---it seems as if it was issued because the deaths were publicized.


here are some excerpts from that 2009 meeting

WASHINGTON STATE PHARMACY AND THERAPEUTICS COMMITTEE MEETING
February 18, 2009

"So I mean…I can’t remember if it’s sixth or third, but the bottom line is Medicaid is almost 50% of all prescription related deaths in the State of Washington and growing. And so we’re just now doing the 2007 runs where we actually load DOH’s death certificate data into our claim system, and so we’ll be able to feedback and see, you know, are we now 50+% of the deaths. And I just think, you know, this is something I’m hopeful the state could start taking on a little bit stronger, because I think this is a distinction that we don’t want, and it just keeps growing. And quite frankly, I’m at a loss of what to do.

"The issue is not just opiates. The issue is who are getting these opiates? And then this is a slide that shows the ratio…or the percent of clients who have a psychiatric dose…or psychiatric diagnoses as it relates to the deaths. And basically, it says that at less than 120 mg of morphine equivalent, you know, a little less than 60% of the people have a mental health diagnosis. What is a sad fact is as we increase the amount of morphine that goes into our clients, the more likely we’re treating also a person that has a mental health issue.

"So we are giving our most vulnerable clients in the State of Washington huge doses of narcotics, and so that’s the first face. The next face applies to substance abuse, so that the more you get in a morphine equivalent, the more likely you are to have a substance abuse issue.

"And when you consider that on top of this we’re treating some of our bi-polar clients and schizophrenic clients and other, now, children who are getting some of these other medications, including the atypical antipsychotics as well as the antidepressants…I mean, the…we just compound the issue.

"And then I think the sad fact is now we’re creeping down into the teenagers. So these are teenage deaths with narcotics that are prescribed to the teenagers who have a coroner or a death certificate data that state on a more likely than not basis that the death was related to a narcotic. (emphasis mine)

"And so what is the distribution by prescribers? Well, you can see that in over 1,000 milliequivalents per day, we have about 35 providers that prescribe in these doses.

"in the 35, it includes the University of Washington, Harborview as well as some very reputable pain specialists as well as some solo practice, ARNPs, and family practice, etc., etc.

"there’s no agreement on how high you can go, and it is a number of small providers that believe that you can go up several thousands of milligrams a day. I think our highest is up to 7,000 or 8,000 milligrams of morphine a day.

"And then again, I think methadone is an issue. I mean, we would hope that these 35 prescribers actually know about the issues with methadone and its depo effect and that small genomic class of clients who might actually have the unfortunate gene history to actually have increased amounts of this. But methadone is not our only high use, it includes hydromorphine as well as fentanyl, and so some of that fentanyl is actually even being used at nursing homes. I mean, that’s a very frequent event where fentanyl is used in lieu of multiple dosing through the day to save some nursing time. But I would stipulate that it’s all the drugs; and just eliminating methadone alone from the preferred drug list is not, I think, the solution. Next slide.

"You know, and again, when we work together…and I think Siri’s come up with a really nice in the original 320 group that were 10 or more prescriptions per month, which we found out was not 100% sensitive and specific for abuse or misuse, that when we notified the prescribers, we saw an instant 25% reduction because of the poly-prescribing issue." Jeff Thompson

"The prescriber got the client into this issue. I’m going to be really…I’m going to be firm. On the 1,000 mg, it is a prescriber issue. It’s not a client issue, because the majority of these clients are getting them from just one prescriber. Out of the 800, there’s about 200 that are getting it from more than one prescriber. So this is a prescriber issue, not a client issue. I’m sorry, these are, but I really…I think that we’ve gotten ourselves into this problem as medical professionals. It’s not the client’s problem. unnamed man

"Jeff, this is Carol Cordy. It sounds like you’ve spoken with some of these 35 prescribers personally
Jeff: Yeah.
Carol Cordy: You have?
Jeff: Yeah.
Carol Cordy: And do they…I mean do you get the sense that they don’t want to be in that position  not to be prescribing all that narcotic?
Jeff: They typically don’t see the problem.
Carol Cordy: They don’t? So there is the problem."
here the discussion about pain killers begins on pg 86

In 2010 Senator Charles Grassley asked for information on the top prescribers of pain medications and neuroleptic drugs because of the rampant illegal marketing, and Medicaid fraud. What is interesting is an email from the Governor's Office:

Why wouldn't  Washington State respond?

 Then there is this:

A top prescriber who accounted for 1-2% of the entire Rx budget but the problem is considered resolved when SHE closes her office---

via The Seattle Times

State plans emergency warning on risks of methadone

Washington state will issue a public health advisory that singles out the unique risks of methadone, a commonly prescribed pain medicine that's linked to the most accidental overdose deaths.

By Michael J. Berens and Ken Armstrong

12-21-2011

A few excerpts:

"To save money, the state steers Medicaid patients, workers' compensation recipients and state employees toward methadone, a long-acting painkiller that costs less than a dollar a dose. Since 2003, at least 2,173 people in Washington have died from unintended overdoses linked to the drug, The Times found.

"Committee Chairwoman Karen Keiser, D-Kent, became frustrated with Dr. Gary Franklin, medical director for the Department of Labor & Industries, which handles workers' compensation.

"Keiser asked Franklin — a principal defender of the state's decision to designate methadone as a preferred drug — if the painkiller is more difficult to manage than other long-acting narcotics. When Franklin responded by discussing the toll of long-acting opioids in general, Keiser said: "Dr. Franklin, answer the question about methadone."

"She later told him: "That's something I'd like to get a straight answer on. And I'm not getting a straight answer."

"Franklin told lawmakers that methadone is not at the heart of the state's struggle with painkiller overdoses. "It's dose, not a specific opioid," he said.

"Almost no one dies from a single opioid. When you look at death certificates, and I've reviewed many of these at L&I, you never see just methadone or just OxyContin or just fentanyl listed," he told the committee.

"Coroners, in fact, will not ever say on a death certificate that this death is from methadone. It is always a combination of multiple opioids plus other drugs."

"But a Seattle Times analysis of death certificates turned up 443 cases since 2003 in which methadone was the only drug listed when someone fatally overdosed. And this was using a conservative sift, excluding cases where the deceased had so much as a history of alcoholism.

emphasis mine)

"Sen. Cheryl Pflug, R-Maple Valley, told Franklin that she was troubled even by those cases in which methadone had combined with other drugs to cause a fatal overdose.

"I don't really care that the coroner isn't willing to say this was caused by methadone," she said. "If the person has a toxic level, and they were taking methadone and other drugs known to have a synergistic, respiratory depressive effect, and they quit breathing, it doesn't take a rocket scientist to know we might have a problem."  State Plans Emergency Warning 12-21-2011

PHARMACY AND THERAPEUTICS COMMITTEE MEETING

February 15, 2012

a few excerpts:

"And we’re left with the background problem, which is what we had when we looked at the Oregon Medicaid study from 2007, which is that the number of people who are prescribed methadone have a much higher rate of substance abuse history and also a much higher risk of opioid death than people prescribed other types of long-acting opioids. And so to pin the cause of those deaths on methadone relative to other long-acting opioids is tricky. And in the 2007 study when they controlled for history of substance abuse there was no longer and increased risk with methadone. I would say that there is no question that this is a very high risk class" Barak Gaster

I'd like to know Mr. Gaster, if this is an accurate statement, how many were dying before??!!

"it’s interesting that when the PDL was instituted in 2004 it coincided roughly with a…the brakes being put on and the rise of methadone deaths. And so it’s hard to say that methadone being on the PDL is contributing in a significant way to the number of deaths." Really Mr. Gaster... 

"So if you remember back in August… this is Jeff Thompson. We brought to you the top 20 prescribers represent 70% of the high dose in Medicaid and we sent letters and gave them feedback reports and I personally called all 20. And they are all actively engaged in the new law. They are getting education. Some are pain specialists. Some are primary care doctors. Some are ARMPs that do refill mills or refills. And all very concerned with what’s going on and are actively engaged with us."  

Susan Rowe: "This may crossover into DUR but we’ve talked about other classes of medications that also increase respiratory depression. And so my thought is that on our agenda for this next year would be to look at some of our pain patients and how many are getting concomitant benzodiazepines, muscle relaxants and other things that put them in danger as drug combinations are used." here

What a good idea! I can't help but wonder why education about the use of prescription drugs and over the counter drugs which pose a risk when used concomitantly with opiate pain medications were not part of prescriber education already... 

via Investigate West

New Prescription Drug Law Holds Promise, but Concerns Linger

JANUARY 22, 2012
By Carol Smith
InvestigateWest

a few excerpts:

"The passage of a new law, regarded as one of the toughest in the nation, makes Washington the first state to require dosing limits for doctors and others who prescribe these medicines. The law, RCW 2876, went into effect January 2, but those who have watched the epidemic spiral out of control still see significant challenges ahead."

Lax Oversight

"A key limitation of the new law: While it gives state regulators a reason to discipline doctors, the statute does not require the state to check whether doctors or other medical professionals are breaking it.

"That’s in contrast to the U.S. Drug Enforcement Administration, which monitors whether medical professionals with narcotic permits are following its rules. The new state program also falls short of Washington’s Medicaid program, which routinely tracks how much narcotic medication doctors hand out. Instead, the system set up by the new law relies on complaints from patients or medical professionals to trigger investigations.

"As a result, the Medical Quality Assurance Commission, which investigates doctors and other healthcare professionals, can’t say how much of a problem excessive prescribing is for Washington doctors, dentists, advanced nurse practitioners, physicians assistants and other providers licensed to prescribe these powerful medications.

"The state’s actions came after the doctor’s offices had been raided the previous year by DEA agents, an action that resulted in charges related to financial transactions the DEA indicated could be used to hide drug trafficking activity.

"Doctors and others disciplined for drug-related issues are usually given chances to go into rehab, get additional training, or pay fines. In 2009, however, Spokane-area doctor Keith L. Hindman, went to prison for health care fraud and prescribing controlled substances for non-medical purposes.

"The DEA, in contrast to the state, does carry out surprise inspections. The agency has shut down the top five prescribers in the state over the last several years, including a clinic in Vancouver, Washington.

"For his part, Thompson of Medicaid sent a letter last summer to the top 20 doctors prescribing opiates to Medicaid patients, alerting them that they’d been flagged for the volume of their prescribing.

“That doesn’t mean they are good or bad doctors,” he said. “There is no definition. However, it does say, it’s worth looking at why they are so high.” here

Jeff Thompson: 

In 2009 there were 35 prescribers that Thompson was concerned about. Between Feb. 2009 and April 2010 the five top pain drug prescribers were prosecuted. A sixth, the top neuroleptic prescriber, whom Thompson stated in his April 22, 2010 email accounted for 1-2% of the entire Medicaid Rx budget closed her office. It seems that it would be advisable to investigate and prosecute her criminal behavior, and perhaps retrieve the money defrauded from the public coffers...NO Effort was made to recoup the money defrauded from the people of Washington through the Medicaid program...   

It appears the warning letters sent were a response to Grassley's investigation. 

A strange thing about the data that Washington State sent to Senator Grassley's office: Why weren't the national provider numbers issued in 2007 used to identify the top prescribers listed?

Medicaid fraud and the failure of medical professionals

"Primum non nocere"
"Declare the past, diagnose the present, foretell the future; practice these acts.
As to diseases, make a habit of two things--to help, or at least to do no harm."
Hippocrates

We have a serious drug problem in this country. Psychiatric drugs are being prescribed to children with behavioral problems caused by social and environmental issues, frequently with ill effect.  The drugs are prescribed often in lieu of Evidence Based therapies and supportive services that are known to be effective, instead of as an adjunct to therapy.  These drugs are not 'safe,' they have very serious risks including iatrogenic illness, disability and death.  Psychiatric drugs are used to treat PTSD in Military Veterans, when exposure based therapies without fatal risks are known to be more effective, and without fatal risk.  Psychiatric drugs are being used to sedate the elderly with dementia, in spite of multiple warnings issued by the FDA that the drugs have an increased risk of fatality for frail elderly with dementia.  For the last decade, there has been  the out of control prescribing of highly addictive narcotic pain killers.  Prescription oxycodone, (Oxycontin) was illegally marketed very successfully. Many are now addicted; significant numbers have died as a result.

According to the New England Journal of Medicine, "users of typical and of atypical antipsy- chotic drugs had a similar, dose-related increased risk of sudden cardiac death." here  It is impossible to know how many children experience life threatening adverse effects, and how many fatalities the drugs cause since this data is not collected; the FDA does not require medical professionals to report adverse events or fatailities caused by FDA approved drugs.

A 2006 article in The Oxford Medical Journal QJM, which is excerpted below, Dr. B.G. Charlton asks the question, Why are doctors still prescribing neuroleptics?

"The Parkinsonian (emotion-blunting and de-motivating) core effect of neuroleptics has been missed by most observers. This failure relates to a blind-spot concerning the nature of Parkinsonism.

"Parkinsonism is not just a motor disorder. Although abnormal movements (and an inability to move) are its most obvious feature, Parkinsonism is also a profoundly ‘psychiatric’ illness in the sense that emotional blunting and consequent demotivation are major subjective aspects. All this is exquisitely described in Oliver Sack's famous book Awakenings, 10 as well as being clinically apparent to the empathic observer.

"Emotional blunting is demotivating because drive comes from the ability subjectively to experience in the here-and-now the anticipated pleasure deriving from cognitively-modelled future accomplishments.2 An emotionally-blunted individual therefore lacks current emotional rewards for planned future activity, including future social interactions, hence ‘cannot be bothered’.

"Demotivation is therefore simply the undesired other side of the coin from the desired therapeutic effect of neuroleptics. Neuroleptic ‘tranquillization’ is precisely this state of indifference.8 The ‘therapeutic’ effect of neuroleptics derives from indifference towards negative stimuli, such as fear-inducing mental contents (such as delusions or hallucinations); while anhedonia and lack of drive are predictable consequences of exactly this same state of indifference in relation to the positive things of life.

"So, Parkinsonism is not a ‘side-effect’ of neuroleptics, neither is it avoidable. Instead, Parkinsonism is the core therapeutic effect of neuroleptics: as reflected in the name, which refers to an agent which ‘seizes’ the nervous system and holds it constant (i.e. indifferent, blunted).4 Demotivation should be regarded as inextricable from the neuroleptic form of tranquillization.2 And the so-called ‘negative symptoms’ of schizophrenia are (in most instances) simply an inevitable consequence of neuroleptic treatment.4 " here

Washington state's medicaid program began monitoring prescriptions of narcotics, antidepressants and other psychotropic drugs to prevent excessive or inappropriate prescriptions and to funnel clients addicted to prescription drugs into treatment, in June of 2005. here

Washington State developed the Partnership Access Line, 'PAL' which is a consultation service that professionals can call for prescription advice, also developed were the Primary Care Principles for Child Mental Health which can be accessed online or can be downloaded as a pdf.  The section Non-Specific Medications for Disruptive Behavior and Aggression of this document recommends neuroleptic drugs, specifically, Risperidone (Risperdal) Aripiprazole (Abilify) Quetiapine (Seroquel) Ziprasidone (Geodon) and Olanzapine (Zyprexa) stating, that, "If used, choosing a single medication is strongly recommended over polypharmacy.  Establish a specific target to treat, and measure the response over time (such as anger explosion frequency, duration)  Aggression is not a diagnosis—continue to look for and treat what may be the cause, usually prescribing psychotherapy."  It then lists other drugs Lithium, Valproate, Carbamazepine, Clonidine, and Guanfacine.   After these recommendations, it states, None of the medications on this page are FDA approved for aggression treatment, with the exception of risperidone (Risperdal) which is approved for irritability/aggression treatment in autism. (emphasis mine)  What this means is there is little to no evidence that quantifies safety, efficacy or effectiveness of the drug recommendations; they are based on consensus not medical science.  These drugs have serious, debilitating adverse effects.   The Practice Parameters for treating schizophrenia in children and adolescents written by Jon McClellan, estimate that 50% of children treated with neuroleptic drugs will develop an iatrogenic, or physician caused, neurological impairment called Tardive Dyskinesia, which is a  mostly irreversible neurological disorder of involuntary movements which can be disabling. 

It is very troubling that prescriptions for neuroleptics, which are teratogenic neurotoxins, are being recommended so casually for undesirable and maladaptive coping  behaviors; particularly since it is also being acknowledged that the behaviors result from environmental conditions.  The behaviors are not symptoms of an underlying medical illness or disease.  The negative effects from the drugs in the short term are not clearly or completely understood or described in the resources developed to guide professionals; and even less appropriate information is shared with parents or guardians to base an Informed Consent to treatment.  What is known is that the drugs have a serious and deleterious impact on multiple physiological processes including cognition; and it is also known that children experience adverse effects more often and more profoundly than adults who take these drugs.  

According to a report on Morbidity and Mortality in People with Serious Mental Illness from the National Association of State Mental Health Program Directors (NASMHPD) Medical Directors Council, "It has been known for several years that persons with serious mental illness die younger than the general population. However, recent evidence reveals that the rate of serious morbidity (illness) and mortality (death) in this population has accelerated. In fact, persons with serious mental illness (SMI) are now dying 25 years earlier than the general population."  These facts suggest it is not advisable or even ethical to prescribe these drugs 'off-label' to children; or  to anyone else.  The fact that it is fraud to submit claims for reimbursement for the costs of off-label prescriptions which are not supported by the Drug Compendia used by CMS for authorizing payment of prescription drugs is apparently not considered an issue.  It is fraud for the prescriber and the pharmacist who causes such a claim to be filed; and this is obviously not a deterrent.  

The reasons for the increased mortality are mainly attributable to the negative effects of the drugs and the iatrogenic illnesses they cause.  These illnesses are then medically neglected by the medical providers who cause them.  

In a training lecture on psychiatric drugs, Grace Jackson, M.D. reported,  
"The Journal of the American Medical Association (aka, JAMA) featured an article by Johns Hopkins University professor, Dr. Barbara Starfield. The article expanded upon the Institute of Medicine’s theme of iatrogenic (treatment-related) death. 

"Using data culled from a variety of inpatient and outpatient investigations, Starfield’s analysis estimated that adverse effects of medication (i.e., “therapeutic” doses of prescription drugs taken exactly as prescribed) account for approximately 305,000 deaths per year. 

106,000 inpatient deaths due to pharmaceuticals

  199,000 outpatient deaths due to pharmaceuticals 

"[Note: Given the fact that “adverse drug reactions” are rarely reported, and given

the fact that drug-related heart attacks, strokes, pneumonias, and cancers are

seldom attributed by physicians or governmental agencies to pharmaceuticals,

these estimates were absurdly conservative.]" Grace Jackson, M.D. here

Jim Gottstein, the founder of PsychRights, has been a fierce advocate for children who are being harmed by psychotropic drugs and psychiatric diagnoses.  He has worked to to stop children from being harmed and to stop the massive amount of Medicaid fraud being committed defrauding the American people.  This fraud continues unabated despite multiple convictions against the drug makers and massive fines being levied.  It is apparent that the pharmaceutical industry considers these fines and the convictions an inconsequential nuisance; it is abundantly clear the fines and convictions have not served as a deterrent to illegal and corrupt business practices.  Jim has written a well thought out and practical solution which needs to be given serious consideration for the sake of the Nation's children.

The narcotic pain killers were have been illegally marketed and over prescribed to the detriment of patients, and like the neuroleptics, narcotics have caused iatrogenic diseases and death.

via Washington State Wire:
"Washington’s death rate is significantly higher than the national average, it said. In the state’s Medicaid programs, between 2004 and 2007, 1,668 patients died as a result of overdoses, about two-thirds involving methadone.

“These findings highlight the prominence of methadone in prescription opioid-related deaths, and indicate that the Medicaid population is at high risk,” the article said. “Efforts to minimize this risk should focus on assessing the patterns of opioid prescribing to Medicaid enrollees and intervening with Medicaid enrollees who appear to be misusing these drugs.” here

via The Yakima Herald and The Seattle Times 

'Elephant in the room'
In December 2010, Dr. Michael Schiesser, a pain specialist in Bellevue, wrote a letter to the P&T committee, retracing the state's history with methadone and crying foul.
When it comes to methadone, Schiesser is the closest thing the state has to a whistle-blower. Three years ago he joined a Health Department work group on accidental poisonings. After that he became involved in legislative deliberations about pain management.

He reviewed transcripts of P&T committee meetings and swept up reports about methadone. The more research he did, the more troubled he became.

Schiesser uses the word "creep" to describe methadone's grip on Washington. As more years passed with the P&T committee saying the drug was as safe as any other, the harder it became for the state to reverse course or hedge by issuing special alerts to physicians of potential complications with methadone.

"So you start to ignore the elephant in the room, which is the mounting evidence," Schiesser says.
His letter challenged a 2008 report that Oregon Health & Science University provided to the committee, saying it "contains errors, deficient logic, and relevant omissions."

The report said one study "found no differences" between methadone and other drugs for overdose risk, when, in fact, the opposite was true, Schiesser wrote. The report mentioned a "black-box warning" from the FDA about OxyContin but not one from the same agency about methadone, he wrote.
In a written reply, an OHSU doctor downplayed Schiesser's points, saying, for example, that FDA black-box warnings are "not evidence."

To Schiesser, such hyper-selectivity has allowed the state to keep saying there's no evidence of methadone being especially risky -- and to the state, no news is good news. He describes the result as: "Because we don't know, therefore it ain't so."
In Washington, medications can go on and off the Preferred Drug List as more evidence develops. The P&T committee meets later this month, when its members will evaluate -- once again -- the safety of methadone.

* Database reporter Justin Mayo and news researchers David Turim and Gene Balk contributed to this report.
* Michael J. Berens: 206-464-2288 or mberens@seattletimes.com; Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com here

Since 2004, Yakima County has seen a total of 44 accidental methadone-related deaths. A Seattle Times analysis found statewide deaths occur in low-income areas at a rate three times higher than that of high-income areas. To save money, the state steers its Medicaid patients to methadone. Learn more of "Methadone and the politics of pain" special section by The Seattle Times

Click on a dot to see the age, sex, occupation and year of death for each decedent.




UPDATE: 6-7-2012 via Seattle Times:
Seattle Times methadone investigation wins Pulitzer Prize
Originally published April 16, 2012 at 1:08 PM | Page modified April 17, 2012 at 6:13 AM

Seattle Times reporters Michael J. Berens and Ken Armstrong won the 2012 Pulitzer Prize in investigative reporting, while Eli Sanders of The Stranger won the Pulitzer in feature writing.

an few excerpts:

"In The Times' three-part series titled "Methadone and the Politics of Pain," Berens and Armstrong revealed that at least 2,173 people died in Washington state between 2003 and 2011 after accidentally overdosing on methadone, which for eight years was one of the state's two preferred painkillers for Medicaid patients and recipients of workers' compensation." (emphasis mine)

"The Pulitzer citation honors Berens and Armstrong for "their investigation of how a little known governmental body in Washington State moved vulnerable patients from safer pain-control medication to methadone, a cheaper but more dangerous drug, coverage that prompted statewide health warnings."

Series brought changes

"The Times series reported that the poor have been hit hardest by the state's reliance on methadone. While Medicaid recipients make up about 8 percent of Washington's adult population, they account for 48 percent of the methadone deaths."

"State health officials had disregarded repeated warnings about methadone's risks, saying it was just as safe as any other painkiller."

"Immediately after the series was published in December, state Medicaid officials sent out an emergency advisory warning of the unique risks of methadone. In January, the state told doctors to use methadone only as a last resort."

"The warnings are likely to have an impact nationally, as Washington state's pain program had been considered a national model." read here

NOTE:  The discussion of methadone and psychotropic drugs begins on page 86
I read the transcripts of the Washington State PHARMACY AND THERAPEUTICS COMMITTEE MEETING that took place on February 18, 2009 and was deeply disturbed.  The manner in which medical privileges are used is the underlying problem; it is an abuse of prescriptive privileges to prescribe drugs without evidence of safety and effectiveness of the prescription.  This abuse of medical privilege is not  discussed in meetings about the negative effects of the drugs and fatalities caused as a matter of course, which result from the standards used in clinical practice.  Medical professionals have an ethical duty to report treatment providers whose patients are harmed by disabling iatrogenic illnesses, and to speak up on behalf of patients who die.  Failure to report to the appropriate authorities in effect and in fact, makes a professional  complicit; it is aiding and abetting criminal behavior after the fact.  Coaching and advising medical professionals who are disabling and killing their patients is not enough; it allows them to harm other patients, while failing to be accountable for felonious medical assault and homicide.   The focus of this committee meeting seemed to be the cost of the drugs, the potential for bad publicity and the fear of being held liable---

It is obvious that Medicaid fraud is not a concern of the Pharmacy and Therapeutics Committee committee.   The committee met in February of 2009 and discussed once again, the number of deaths which are attributed to methadone for people on Medicaid.  This was a discussion which had been going on for 3 or 4 years, according to the transcript.  The policy was not changed until after the number of deaths were  publicized in the Seattle Times.  The fact that the committee members were aware of the high number of deaths for several years yet failed to act, makes it clear that the best interests of Medicaid patients are not a primary concern of the committee or Washington State's Medicaid program.

"Whenever a doctor cannot do good, he must be kept from doing harm." 

Hippocrates

Pig Pharma and Psychiatry

Because of the attention being brought to the issue of using psychiatric drugs on children, there have been some efforts to get a handle on the over-prescribing of these dangerous neurotoxins to foster children in the State of Washington.  It would be more accurate to say  there is quite a production being made about 'taking action;' it gives the impression that the SOW is actively 'doing something,' and I am sure they are. It just doesn't seem what they are doing is making changes that focus on doing right by the children who are wards of the State of Washington.  A study conducted that was paid for by the people of the State of Washington; all of the authors are State employees and/or teach at the University of Washington, but the report is only available in a psychiatric professional journal.  Why would a study paid for by the  people of Washington State be available in a journal that the general public does not have ready access to?  It's safe to assume that most folks in Washington State do not subscribe to the Journal of the American Academy of Child and Adolescent Psychiatry; Washington's citizens paid for the study, why should we have to pay $12.00 to read the report? 

via the Journal of the American Academy of Child and Adolescent Psychiatry:

Second Opinions Improve ADHD Prescribing in a Medicaid-Insured Community Population
Jeffery N. Thompson, M.D., M.P.H., Christopher K. Varley, M.D., Jon McClellan, M.D.,
Robert Hilt, M.D., Terry Lee, M.D., Alan C. Kwan, B.A., Taik Lee, M.A., Eric Trupin, Ph.D.

Dr. Thompson, is the Director of Washington State's Medicaid programMr. Kwan, and Mr. Lee are with the Washington State Department of Social and Health Services; and Drs. Varley, McClellan, Hilt, Trupin, and Lee are with the University of Washington

Accepted 14 January 2009.

Disclosure: Dr. Varley is on the speakers' bureau of Novartis. The other authors report no conflicts of interest.

Abstract 

Objective
The appropriate use of psychotropic medications in youths is an important public health concern. In this article, we describe a review process developed to monitor the use of stimulants and atomoxetine for attention-deficit/hyperactivity syndrome (ADHD) in youths receiving fee-for-service Medicaid services.
Method
Washington State Medicaid developed threshold safety parameters for ADHD medications through a process involving the community. A second opinion was mandated when safety thresholds based on dose, combination therapies, or age was exceeded. Use and cost were compared 2 years before and after the program began.
Results

From May 2006 to April 2008, 5.35% of ADHD prescriptions exceeded safety thresholds, resulting in 1,046 second-opinion reviews. Of those, 538 (51.4%) resulted in a prescription adjustment. Adjustments were made to primary care physician (52%), psychiatrist (50%), nurse practitioner (54%), and physician assistant–written (51%) prescriptions. When the preperiod and postperiod were compared, second opinions reduced ADHD medication at high doses (53%), in combinations (44%), and for patients 5 years of age and younger (23%). The review process resulted in a savings of $1.2 million, with 538 fewer patients exceeding safety thresholds. This was a 10:1 return over administrative costs; however, the overall Medicaid expenditures for ADHD medication still increased because of higher unit costs and the preferential use by clinicians of newer brands entering the market.
Conclusions

A statewide second-opinion process reduced outlier ADHD medication prescription practices and was cost-effective. Suggestions for process and quality improvements in prescribing to children diagnosed with ADHD are discussed. J. Am. Acad. Child Adolesc. Psychiatry, 2009;48(7):740–748

"All activities outlined in this article were funded with state and federal funds through the Washington State Medicaid program. The views in this article do not constitute official policies of the state of Washington or the federal government. The authors thank the dedicated staff of Washington's Department of Social and Health Services for their tireless work in assisting Medicaid clients and balancing clinical and administrative complexities." 
(emphasis mine)  here

Why select the class of drugs used for  ADHD diagnosis and not the drugs which are prescribed off label to 'treat' the behavioral and emotional difficulties a child has?  These difficulties are often simply a child's desperate attempt to have their needs met, not diseases that require teratogenic drugs.  Pharmaceutical drugs do not address a child's need for security, appropriate supervision and unconditional love.  The environmental conditions include the deficits a child's caretaker's have; whether the deficits are due to lack of education and financial resources, or neglect and abuse .  The symptoms  of emotional and  behavioral issues are perceived by many to require a psychiatric diagnosis and psychiatric treatment.  To be clear, I am speaking about the majority of children who end up in State care who are thought to need psychiatric drugs, when the child or adolescent does not have any identifiable physiological or neurological condition.  This definition excludes most of the diagnoses applied to children, who have emotional and behavioral problems because of abuse and deprivation; the obvious solution is simply to meet their needs consistently, and then see if they need help to process the effects of being abused and neglected.  They do not need to be told they have something wrong with their brains because the adults in their lives have not provided for their needs appropriately. Their symptoms are not likely to be caused by a mysterious and still not identified underlying disease, and telling kids this myth, is dishonest.  

The decision to study the one class of drugs that is rarely used 'off-label' is suspect. The class of drugs with the most research supporting their use, are not the drugs which pose the greatest risk to children's safety. The drugs are also not responsible for the massive amounts of Medicaid fraud which continues unabated.  The Medicaid fraud should at least be a secondary priority.  The project reported in this article is part of an effort to mitigate the harm being done to children and teenagers in the foster care system by psychiatric drugs.  Why purposely target a class of drugs that are FDA-approved for pediatric use?   

It is important to address prescribing of pharmaceutical grade speed to young children.  However, the larger risk is the neuroleptic drugs, called Second Generation Antipsychotics, or SGAs, being prescribed 'off-label' prolifically; the cost of which is fraudulently billed to the Federal Medicaid program.  In order for a prescription drug's cost to be reimbursed through the Federal Medicaid program, a drug must be FDA-approved for the reason it is prescribed; or listed as having scientific support for the purpose it is being prescribed in one of the recognized Prescription Drug compendia used by HHS and Medicaid.   

Purposely targeting FDA-approved prescriptions instead of the 'off-label' prescription of drugs without FDA-approval and unsupported in the compendia is simply irresponsible and suspect.  How does this focus on pharmaceutical speed serve the best interests of the children who Wards of the State of Washington? How will it serve to protect them from the neuroleptic drugs or the SSRI antidepressants which are commonly prescribed off-label and have the potential to cause chronic, disabling and even fatal iatrogenic diseases? 

The Morbidity and Mortality in People with Serious Mental Illness report details some pretty sobering statistics for the adults who take neuropeptics and other psychotropic drugs. In spite of the disabling and fatal adverse effects of psychotropic drugs, they are used off label indiscriminately even though the risks are declared to be much more profound for children and adolescents. There is no effort to stop the prolific off label use of teratogenic drugs on vulnerable children; no plan to stop disabling and killing children. No plan to stop defrauding the American taxpayer. This may be because we are expecting those we entrusted (the same professional group that initially recommended the drugs off label for pediatric use) to slow down the obscene proliferation of off label prescribing--- 

It goes without saying, but I'll say it anyway, these professionals are defending Human Experimentation on children which is now a Standard Clinical Practice, but is not ethical or "necessary medical treatment." It's a human rights crime. 

It appears that they are not serving children's best interests;
 they are serving the interests of  Pig Pharma...  

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The Plan: monitor a dangerous paradigm of care

On April 30, 2012 I found out that the PolicyLab at The Children's Hospital of Philadelphia announced the publication of an article in the professional Journal, Children and Youth Services Review Science Direct.  The article is part of the follow up to the Senate Investigation into the use of psychotropic drugs on foster children.  This article is to report on the prevalence of psychotropic drug use on foster children served by Medicaid in 47 states and the District of Columbia over a six year period.  I read the press release online in the Wall Street Journal’s Market watch, which proclaims this study, “lays the groundwork for state-level action.”   I was eager to read the actual journal article.  I couldn’t afford the $20. fee to access the article online, so I contacted the Philadelphia Children’s Hospital’s public relations office and the staff sent me a copy.  

The press release quotes the lead author, David Rubin, M.D., "We're not saying these medications should never be used for children, but the high rate at which they're used by children in foster care indicates that other interventions and supports, such as trauma-based counseling, may not be in place for them. In other words, health care providers may not have other, non-medication, tools to offer families dealing with mental health concerns," said Rubin. "Responding to high and growing levels of antipsychotic use will not simply require efforts to restrict their use, but calls for larger investments in mental health programs that help these children cope with trauma psychologically."   

Reading the article itself, I was struck by the fact that there is no mention of the best interests of foster children. Ultimately the press release in Business Watch was a gross exaggeration of what the article itself delivers.  The Journal article doesn't lay much groundwork, nor does it outline a meaningful plan of action. The article fails to offer much hope of meaningful change, or an ethical effort to protect the health and lives of children in foster care. The press release sadly, was a disappointing distortion of the Journal Article.  ACYF plan on continuing to allowing foster children to be prescribed psychiatric drugs in the absence of empirical evidence of efficacy AND safety; and without a medical indication, which is referred to as Off Label, (probably because it sounds a lot less serious than Human Experimentation) is not ethical medicine. it is not moral or legal to allow children to be given ‘treatments’ which have no scientific evidence to support their use. The well-documented negative effects of the neuroleptic drugs, calls for stronger action than merely ‘monitoring’ their continued use, and compiling Adverse Event statistics.  All due respect to the professionals who produced this article, reporting the story without mentioning the fact that there is a great deal of controversy over the off label use of neuroleptic and other psychotropic drugs in children, is not ethical journalism. The a plan to monitor what is in reality, a gross departure from ethical medical standards in the Hippocratic tradition, cannot be in foster children’s best interest.

What Bryan Samuels, Commissioner of the Administration on Children, Youth and Families (ACYF) needs to do is stop allowing children in the Child Welfare system to be used as a means to defraud Medicaid, and stop allowing children to be drugged without a valid medical reason.  The neuroleptic drugs are teratogenic and experts estimate 50% of children who are given the drugs for schizophrenia are expected to develop Tardive Dyskinesia---this can be permanent and disabling...

When did off-label prescription of drugs absent any definitive evidence, no indication e.g. empirical evidence for safety or efficacy for the purpose prescribed become ‘Standard Practice’?  How in the hell did giving children drugs with serious disabling and even fatal risks ‘off-label’ become an acceptable medical practice without any evidence of efficacy? Safe the drugs are not.  It is obviously not based on ‘sound medical judgement’ or ethical medical principles; there is no evidence base for what is and has been Standard Practice for decades.  It is also Medicaid Fraud--drugs prescribed off-label with no recognized indication, billed to Medicaid.  Even after decades of using neuroleptic drugs to ‘treat’ aggression in children; there still is no body of evidence to support using neuroloptics off-label to treat aggression?  How can this be?

I suspect there is evidence that indicates this is not a good idea, and that it is not a medically valid use for these drugs.  I know if there were in fact valid evidence to support what is ‘off-label’ use, it would be trumpeted in all the ‘peer-reviewed’ journals.  This is not medicine being practiced in the Hippocratic tradition; dangerous neurotoxins usedon children without an evidence base to support the drugs use; it is in fact experimental treatment on vulnerable Humans.  ACYF has carelessly and purposely allowed foster children to be used as guinea pigs in drug trials. These children are offered no legal protection; not even the Nuremberg Code protects these human test subjects. ACYF acting in loco parentis for foster children, has failed to protect them from iatrogenic injury, failed to preserve their Human Rights, and has allowed them to be guinea pigs in real world practice using neurotoxic drugs. The data gathered for the Children and Youth Services Review doesn't even mention the toll of iatrogenic injuries, illnesses, adverse events and fatalities...This data is relevant and germane to the discussion, and is not even mentioned...

ACYF is and has been allowing foster children to be medically treated with dangerous drugs which are not tested or approved for the reasons the drugs are prescribed to the children in State Custody.  Prescribing neurotoxic psychiatric drugs ‘off-label’ e.g. without a valid medical indication, is unethical. Allowing it to continue fails to protect children from iatrogenic injuries and chronic diseases.  Psychiatrists who defend this mistreatment of their patients, because psycho-social and cognitive behavioral treatments are unavailable; are attempting to justify unethical medical practices.  The drugs do not ‘treat’ an identified pathology; but all neuroleptic drugs, and many other psychiatric drugs in other drug classes can cause serious illnesses and even sudden death.

This plan is not child-centered; and it certainly does not appear to be driven by the needs of foster children who are in need of mental health services. Mental Health Services and systems planning in every respect are to be child centered, and family directed---this is what Medicaid Guidelines require. There is no child-centered family driven voice in this plan. Ultimately, this may be why instead of the discussion being centered on what is in the best interests of foster children; it is focused on sustaining and monitoring a fractured paradigm of care, using dangerous psychiatric drugs in lieu of humane, ethical psycho-social and cognitive behavioral mental health treatments for children whose mental health care is paid for by Medicaid.

Seems to me some of those billions in off-label marketing fines could be spent to provide evidence based therapies for foster kids, instead of allowing the off-label Medicaid fraud to victimize them...
ineffective for treating aggression

“Or just don’t do it. We know that behavioral treatments can work very well with many patients.”  Dr. Johnny Matson

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