The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

TeenScreen – Another Gross Distortion

Evelyn Pringle August 1, 2005

Here’s another gross distortion of the truth by TeenScreen. On its web site, in response to the question, is TeenScreen related to TMAP, the Texas Medication Algorithm Project? It says: “No. … Some Web postings inappropriately and inaccurately claim that TeenScreen is a bridge to medication and hence the TMAP program. This is entirely false.”

“There is absolutely no relationship between TeenScreen and TMAP. … TeenScreen does not endorse any particularly mental health treatment or medication.”

“TMAP … is a medication formulary for seriously mentally ill adults in Texas. The adults served by this program are cared for in public programs. TeenScreen and TMAP have nothing to do with one another.”

That’s what TeenScreen says. Now lets look at the truth.

Simply put, a TMAP (aka, algorithm) is a list of drugs that doctors are required to use in treating persons with specific illnesses who receive medication funded by the government with tax dollars.

Contrary to what TeenScreen claims, this list is not limited to mentally ill adults in Texas. In fact, Texas has a children’s version that apes the adult version and is used for kids in hospitals, foster care institutions, prisons, juvenile programs and every other public program that is funded with tax dollars in Texas.

It all started in the mid-90s while Bush was governor. TMAP was developed by what’s referred to as an “expert consensus” made up of a group of “experts” already known to have favorable opinions of certain drugs, chosen by drug company sponsors, Janssen Pharmaceutica, Johnson & Johnson, Eli Lilly, Astrazeneca, Pfizer, Novartis, Janssen-Ortho-McNeil, GlaxoSmithKline, Abbott, Bristol-Myers-Squibb, Wyeth-Ayerst and Forrest Laboratories.

In 1997-98, with pharma funding, a panel was assembled to determine which drugs would be used in treating children and decided that the same drugs used on adults could be used on kids. There were no studies conducted to test the safety of giving the TMAP drugs to kids and most had never been FDA approved for use by children.

Experts are speaking out against these lists. According Dr Grace Jackson, author of the new book, Rethinking Psychiatric Drugs : A Guide for Informed Consent, “Outside of emergency & trauma medicine, where algorithms can and do save lives, the use of medical flowcharts and guidelines must be evaluated carefully and critically. This is because the algorithms have arisen from “Evidence Based Medicine” — a statistically based approach to studying treatment effects in populations, rather than a reality based approach to discerning treatment effectiveness in each unique individual.”

The TMAP is still being used to push drugs on kids in Texas, according to an article by the Associated Press on February 09, 2005, “As lawmakers work to revamp Texas’ foster care system, they also are reviewing the use of mind-altering drugs by foster children.”

In October, 2004, the Texas inspector general for the Health and Human Services Commission said his office interviewed staff at three state licensed wilderness camps, which provide care for foster children, and found that the average child arrives on four or five psychotropic drugs.

After investigating the issue of drug use with foster kids, in an April, 2004 report, Texas Comptroller, Carole Keeton Strayhorn, blasted the agency for giving children drugs so “doctors and drug companies can make a buck.”

An update on Texas, comes from noted author Dr John Breeding who reports, “We are fighting off a swarm of efforts to codify New Freedom language into Texas law. Driven by Big Pharma and psychiatry, Texas is a focal point as the Texas Medication Algorithm Project started it all, the same folks were behind the New Freedom Commission, and the end result is more and more folks on drugs,” said Breeding.

TeenScreen’s underlying motive is to recruit customers to funnel money to pharma by drugging kids and a TMAP model, under whatever name it goes by in each state, is the list of the drugs that the new customers will be given. In fact to push the overall scheme along, the Bush appointed New Freedom Commission (NFC) has recommended that TMAP be used in all 50 states.

And it is spreading to other states. In Ohio, the list is called “OMAP” and includes all the high-priced psychotropics such as Paxil, Zyprexa, Adderall, Zoloft, Risperdal, Seroqual, Depakote, Prozac, Wellbutron, Zyban, Remeron, Serzone, and Effexor.

But first things first, they have to get TeenScreen in schools and this is where the NFC comes in. Its recommendations include, “Early detection of mental health problems in children and adults – through routine and comprehensive testing and screening – will be an expected and typical occurrence.” “Both children and adults will be screened for mental illnesses during their routine physical exams.”

Citing recommendations by the NFC, TeenScreen’s Executive Director, Laurie Flynn, reports the Bush plan, “to launch a nationwide mental illness screening program in government institutions, including the public school system, for all students from kindergarten up to the 12th grade.”

While testifying before the committee on March 2, 2004, Flynn praised the NFC for recommending TeenScreen. “I am especially pleased to report that the commission named the … TeenScreen Program a model program for early intervention.”

Flynn’s testimony discussing TeenScreen’s goal of finding students to “link them with treatment:”

“In 2003, we were able to screen approximately 14,200 teens at these sites; among those students, we were able to identify approximately 3,500 youth with mental health problems and link them with treatment. This year, we believe we will be able to identify close to 10,000 teens in need, a 300 percent increase over last year.”

Make no mistake, the lists are being used to drug children and any new recruits will end up on drugs.

For instance, according to a report in the April 25, 2005, Columbus Dispatch, as of July, 2004, nearly 40,000 Ohio children on Medicaid were already on psychiatric drugs. After concerns were raised nationally about the number of kids being medicated, a reporter for the Dispatch investigated prescriptions records paid for by the Ohio Medicaid program and discovered that 31% of children ages 6 to 18 in foster and group homes, were on mental-health drugs. And 22% of kids in detention were on psychiatric drugs as of January, 2005, with many on five or more.

These drugs have never been approved for kids and they have been found to cause suicide and violence. Nearly all the children involved in violent rampages in recent years have been on the antidepressants known as SSRIs.

Christopher Pittman, the 12-year-old who shot and killed his grandparents while they slept, and then burned down the house, was on Zoloft. In describing the event, Christopher said it was like he was watching a show on television and that he could see everything happening but there was no way to stop it.

One of the country’s leading experts on SSRIs, Dr Ann Tracey, explains that people on these drugs, like Christopher, will appear as if they are wide awake, when in fact they are half asleep walking around in a dream-like state.

Despite the testimony of two highly qualified psychiatrists that Christopher was “involuntarily intoxicated” on Zoloft that night, the jury found him guilty, and barring a miracle, this poor child will sit in prison for the next 30 years because a negligent doctor placed him on a lethal medication.

Dr Grace Jackson is against giving kids drugs. “It would be difficult to engage in a form of medical experimentation more potentially hazardous than child psychopharmacology. With increasing frequency, researchers have demonstrated how and why the psychiatric drugs are powerful neuroendocrine disruptors which exert negative effects upon cognition, growth, metabolism, and reproductive functioning,” she explained.

According to Jackson, “The question should not be whether or not American children are being “overdrugged” — rather, the question should be: what evidence justifies the drugging of even one child ?”

State Officials Compromised By TMAP

Allan Jones was an Investigator in the Pennsylvania Office of Inspector General, when the PennMap scheme was set up in Pennsylvania. According to Jones, “TMAP and the NFC represent the deceptive marketing of fraudulent science through the corruption of our governmental safeguards at all levels.”

When charged with examining the receipt of drug company funds by state employees, Jones said, “I began to look at the overall issue of Pharma marketing and immediately became alarmed that the tactics used in marketing to the private sector were being replicated with public employees. Trips, perks, travel, honorariums, consultant fees etc.”

“The most shady aspects of the program emerged quickly,” he said, “the recommended drugs were exclusively new, patented and expensive and were selected by persons with financial ties to Pharma; and the claims of increased efficacy and safety made by the drug companies and State employees, were contradicted by the available science,” Jones discovered.

“The pharmaceutical industry purchased the “opinions” of a few key doctors and the endorsement of a few key state administrators, and in exchange they illicitly opened the market for billions of tax dollars spent on dubious and dangerous drugs,” Jones said.

Pharma giant, Janssen, took the lead in exerting influence over state officials by creating “Advisory Boards” made up of State Mental Health Directors who were regularly treated to all expense paid trips and conferences. By influencing 50 key officials, the company knew that it would have a good shot at getting a TMAP list adopted in every state.

For example, Ohio Mental Health Director, Michael Hogan, and California Director, Stephen Mayberg, are New Freedom Commission members who control mental health services in their respective states, and both are members of a Janssen advisory board.

Hogan has proven to be so useful that Eli Lilly has given him a “Lifetime Achievement Award.” In granting the award it was noted that Hogan had given over 75 presentations at conferences since he accepted the position on Bush’s New Freedom Commission.

According to my ace records researcher, Sue Weibert, every conference that she was able to track down that featured Hogan, was sponsored by drug companies, and the group that organized the conference solicited money from pharma to pay the key note speaker.

Hogan is also on TeenScreen’s Advisory Board.

In Florida, Flynn has Jim McDonough, the Director of the Florida Office of Drug Control, in her back pocket.

In a March 22, 2004 email to McDonough she griped about paying the Florida gang $120,000 a year and not getting enough in return. “We’ve been working with David Shern and USF for 18 months or so and still haven’t got a program going,“ she said, “At this point I’m inclined to re-think the use of our resources. We’re sending about $120k to USF annually. … but ultimately we’re not achieving our goals in the community,” she wrote.

Flynn went on to tell McDonough that she had to find kids to screen and said, “I’m looking for a horse to ride here!”

At this point, the NFC, TMAP, and TeenScreen, working together, have managed to weave together a web of key government officials who control funding for the nation’s mental health services in states all across the country.

By using TeenScreen, pharma has hopes of roping in 7-12 million new customers, according to Flynn’s March 2002 testimony:

“The need for increased … screening is evidenced by the fact that close to 750,000 teens are depressed at any one time, and an estimated 7-12 million youth suffer from mental illness. While treatments are available for these severely disabling disorders, sadly, most children do not receive the treatment they need. Among teens that are depressed, 60-80 percent go untreated.”

State Officials Starting To Get Busted

As it turns out, bribing state officials is really not uncommon. In Pennsylvania, Allen Jones discovered that Janssen and Pfizer had both been courting the same guy, Steve Fiorello, the State Pharmacist. Each company had paid Fiorello as a consultant, treated him to travel accommodations, and provided him with educational grants to promote PennMap.

Fiorello was in a unique position. He was paid about $82,000 to oversee pharmacy operations at Pennsylvania’s mental health hospitals, and he was also a member of the committee that determined which drugs would be on the PennMap list for doctors to prescribe at those hospitals.

When finally busted, the ethics commission charged that he “played both sides; he participated with Pfizer … as to its drug-selling strategies, and he participated on the committee as to selecting drugs for the state formulary.”

A 101-page report said Fiorello had earned money from Pfizer while serving on a panel that chose what drugs would be used and that he improperly took money from Janssen and Duquesne University. The Commission fined him $27,000.

An April 2002 company publication showed that Janssen knew exactly what it was paying for. Under Faculty Bio, Janssen described Fiorello as being “responsible for the formulation of policies and procedures for drug use for ten state hospitals and facilities including the development and implementation of the PENNMAP project.”

Flynn & Hogan – Expert Consensus

So where does TeenScreen fit in here? After all, it insists on its web site that it is absolutely not involved with this list business.

Well low and behold, that’s not quite true. Just look what my talented records researcher, Sue Weibert, discovered in “The Journal of Clinical Psychiatry,” Vol 60, 1999 Supplement 11: under Expert Consensus Guideline Series: Treatment of Schizophrenia 1999.

Here we have none other than Laurie Flynn listed as an “expert” who took part in creating the list. She surely must have forgotten about this.

Flynn and her band of pushers from the National Alliance for the Mentally Ill (NAMI) must be geniuses when it comes to picking drugs because 39 members of NAMI got to cast votes in determining which drugs could be on this list. The only group with more votes than NAMI was academic experts with 42 votes.

Another “expert” who took part in this “expert consensus” process was Flynn’s good buddy, Mr Mike Hogan.

On its web site, TeenScreen claims that it does not endorse any specific drugs. Well the author obviously did not check with its Executive Director because she sure does.

Surprise, surprise! “Experts” Flynn and Hogan recommended the most expensive drugs on the market for the treatment of schizophrenia: Risperdal, Seroquel, and Zyprexa.

No affiliation with drug companies either huh? According to the report, “This project was supported by unrestricted educational grants from Eli Lilly and Co; Janssen Pharmaceutica, Inc; Novartis Pharmaceuticals Corporation; Ortho-McNeil Pharmaceutical; Pfizer, Inc; Zeneca Pharmaceuticals.”

The truth is, NAMI is pharma’s main front group and is used to implement every marketing scheme the industry dreams up. As its former Executive Director, Flynn was its top pusher for 16 years. The group even admits that its goal is to help pharma “grow the market,” in an excerpt from the its 2000 990 entitled, “Guidelines for the Relationship between NAMI and the Campaign’s Founding Sponsors.”

Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market. A. NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders, by giving professionals and providers the NAMI perspective, by bringing into treatment persons who are not being served, and by helping persons to adhere to their treatment plans. (2000 990 is available at Guidestar.com).

On March 2, 2004, Flynn testified at a congressional hearing that in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and substance abuse.

This is amazing, if Flynn is right, all it takes is ten minutes and a paper and pencil to unearth any one of 30 deep-seeded mental illnesses. I’m surprised they haven’t figured out a way to cut out the middle-man doctor and set up a drive through for kids to go pick up their pills at Walgreens without a prescription. That’s probably in the works.

Experts warn that TeenScreen will do more harm than good. “It is impossible, on cursory examination, or on the basis of the Program’s brief written screening test, to detect suicidality or “mental illness,” however we define it. Indeed, the fears evoked by the process of seeking out mental illness can create psychiatric symptoms,“ according to Dr Nathaniel Lehrman, MD, former Clinical Director, Kingsboro Psychiatric Center, Brooklyn NY; former Assistant Clinical Professor of Psychiatry, Albert Einstein and SUNY Downstate Colleges of Medicine.

“Searching out those “illnesses,” rather than relying on the troubled to seek help for themselves, violates the privacy of those in whom these “illnesses” are sought,” Lehrman warns, “for those youngsters whose screenings supposedly reveal such “mental illness,” the major treatment will then be drugs.”

“Aren’t eight million kids on ritalin enough?” Dr Lehrman wants to know.

TeenScreen is always bragging that its screening tools are free. Apparently that was also a scam to convince schools to adopt the program. According to a September 27, 2004, email to Jim McDonough, schools will have to pay a fee beginning in 2006:

“The DPS (the 19 minute computer administered screening tool) that TeenScreen offers has been sold to Mental Health Systems … Sites can continue using the DPS, but starting Jan 2006, they will have to pay a few hundred dollars. (The exact prices is yet to be decided) … The DPS will still be offered by TeenScreen, it will just not be free anymore.”

On December 4, 2002, Flynn spoke to the NFC, and explained the cost of setting up one TeenScreen program: “Implementation in just one school district often requires piecing together over a dozen funding streams from the education and mental health fields.”

Think about that for a minute, “piecing together over a dozen funding streams.” So how much are local tax payers going to end up paying for school employees to set up a TeenScreen program in every school?

Something is very wrong here. This is pharma’s marketing scheme, yet tax payers are paying to set it up, paying school employees to administer the survey, paying for “clinicians” and “case managers,” and in 2006, the use of the survey itself will cost money.

On top of all that, mark my word, tax payers are going end up paying for shrinks for students without insurance and Medicaid programs will end up funding at least three-fourths of the drugs prescribed.

As I’ve said before, this has got to be the most brilliant scheme that I have come across in my 2 years of investigating the pharmaceutical industry. Its all profit – tax dollars funneled through kids directly into pharma coffers. Brilliant.

No Laughing Matter

The pharmaceutical industry is taking over the world right before our very eyes. The harmful effects of the drug-makers’ take-over is well-documented in Bob Whitaker’s book, “Mad In America.”

Right now pharma has over a 100 NAMI type marketing front groups in place all over the globe. It has succeeded in greasing enough palms to compromise the few government officials necessary to control the Federal and State funding allocated for prescription drug programs, and it has doctors in every field of medicine writing out prescriptions for expensive psychiatric drugs as if they were the cure-all for everything under the sun.

Its gotten so bad, that Dr Lehrman notes a need for public awareness of the extent to which the American medical profession is being prostituted by the drug companies, “In no other medical specialty has that prostitution reached the depths it has in my specialty, psychiatry,” he added.

Pharma has infiltrated the staff responsible for prescribing drugs in the country’s health care facilities, to boost profits by overmedicating patients, with most of the funding coming from tax dollars, causing state Medicaid programs to go broke left and right.

In addition, it controls the media with billions of advertising dollars so that when it does get busted for hiding harmful effects of drugs that kill people or paying doctors to push drugs for ailments they were never approved for, or shooting poisonous vaccines into infants for profit, or any of the other 1000 money-making schemes that its got going on any given day, the story might make front page headlines for a day or two at most.

It took hold of the nation’s regulatory agencies by making sure to get the majority of government researchers and scientists on their payrolls so that they will readily approve new drugs and then allow companies to make a killing off selling new drugs by hiding their adverse effects until people start dropping over dead.

But most importantly, Pharma has gained a stronghold on every branch of government by funneling a steady stream of campaign cash to politicians to make sure that favorable legislation is passed and investigations of industry crimes are shut down.

Last, but certainly not least, it now appears more and more likely every day that pharma is going to have its way with the nation’s children via the public school system. God help us.

(Records researchers, Sue Weibert and Ken Kramer contributed to this report)

Filed under: 2005, antipsychotics, drugging children, front groups, NAMI, NFC, RWJF, TeenScreen, TMAP

TeenScreen Sets Up Shop In Illinois

Evelyn Pringle June 20, 2005

A controversial plan to screen all Illinois school children for mental health disorders is set to become a reality on June 30th, if the Governor accepts the final proposal from the Illinois Children’s Mental Health Partnership (ICMHP).

Illinois became the first state to hop on the bandwagon for President Bush’s New Freedom Commission’s (NFC) plan to subject all American school children to mental health screening. In 2003, Illinois Lawmakers passed the $10 million Illinois Children’s Mental Health Act (ICMHP), creating a Children’s Mental Health Partnership, which many expect to become a model for other states.

The Final Report by the Illinois Children’s Mental Health Task Force was released in April 2003 and it is filled with intrusive and expensive recommendations. The ICMHP held hearings in various locations across the state in 2004 to gather public feedback on the plan.

While its proposals seem harmless enough at first glance, comments from parents during the hearings raised many valid concerns. The State, critics said, no longer assumes that Illinois children are mentally healthy, it presumes all children need mental health screening.

The Task Force Report calls for a comprehensive, coordinated children’s mental health system comprised of prevention, early intervention, and treatment for children ages 0-18 years and for a statewide data-reporting system to track information on each person, and social-emotional development screens with all mandated school exams (K, 4th, and 9th),

The Task Force wants to: Start early, beginning prenatally and at birth, and continue throughout adolescence, including efforts to support adolescents in making the transition to young adulthood.

Karen Hayes, associate director of Concerned Women for America-Illinois published an Opinion Piece in the Illinois Leader on July 23, 2004 and had a great idea. She said maybe the legislators should be mentally evaluated.

Concerned parent, Joseph Volpendesta, feels the same way. “Mental Health screening might be much more usefully employed on these people who come up with these brainstorms; it is obvious that they have far too much time on their hands and too little regard for those of us who are paying the bills. What is needed, and at the earliest opportunity, is a bill to rescind this piece of legislative claptrap. … There is no doubt in my mind where the mental health screening is most needed and it ain’t the kids,” he said in a letter to the editor of the Illinois Leader June 13, 2005.

TeenScreen Customer Recruitment Scheme

At the center of the controversy is program called TeenScreen designed by pharma backed officials at Columbia University. TeenScreen is supposedly a suicide-prevention program and is recommended by the NFC, even though a recent US Preventive Services Task Force study found “no evidence that screening for suicide risk reduces suicide attempts or mortality.”

Columbia claims the TeenScreen survey can assess the symptoms of 8 disorders associated with the risk of suicide or mental illness. On March 2, 2004, the program’s Executive Director, Laurie Flynn, testified at a congressional hearing and said that in screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

In May 2004, Illinois lawmakers passed a resolution approving the implementation of TeenScreen in public schools, which said in part: (1) “Columbia TeenScreen Program”, has been proven successful, offers technical assistance for implementation of a screening program, and provides all the components for such a program at no charge at this time; (2) that we recognize that mental illness and suicide among young people are public health crisis in this State and that all residents of Illinois should make the identification of mental disorders and the prevention of suicide among the young people a public health priority; (3) that every young person should be screened … to identify mental illness and prevent suicide; and (4) That such a screening and identification process should employ sound, evidence-based tools.

The problem is that TeenScreen is not an evidence-based tool. The program had already been in place for 6 years in Tulsa, Oklahoma when the suicide rate rose drastically, causing Michael Brose, the leader of a mental health partnership organization there, to say, “To the best of my knowledge, this is the highest number of youth suicides we’ve ever had during the school year — a number we find very frightening.”

TeenScreen is an invention of the pharmaceutical industry and is nothing more than a customer recruitment scheme to help generate high volume sales of costly psychiatric drugs. By infiltrating the nation’s public school system, it will generate millions of new prescription drug customers.

“More screened kids means more money for psychiatrists and the pharmaceutical industry,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient advocacy group, to the Chicago Tribune on June 5, 2005.

“It is important to understand that powerful interests, namely federal bureaucrats and pharmaceutical lobbies, are behind the push for mental health screening in schools…the pharmaceutical industry is eager to sell psychotropic drugs to millions of new customers in American schools,” said Rep Ron Paul, R-Texas, who happens to be a physician.

TeenScreen made its Illinois debut last fall at the Brimfield High School in the Peoria area and reports indicate that several more Illinois schools will be implementing the program next year, according to investigative reporter, Rhonda Robinson.

TMAP & IMAP

Do the big drug companies have so much power? Why else would this be happening? It looks like a way to make more young people dependent on prescription drugs earlier in life when all they really need is to deal with growing up, just like we all did before there was a drug for every ailment and new ailment to justify even more new drugs,” parent, Dennis McLouth, of Roseville, Ill, wrote in a letter to the Editor of the Illinois Leader on June 13, 2005.

My answer to Dennis is yes the drug companies are that powerful, and it gets worse. The NFC recommends a drug treatment program called the Texas Medical Algorithm Project (TMAP) that specifically requires doctors to prescribe the newer generation of psychiatric drugs to children, including the antidepressants known as the Selective Serotonin Reuptake Inhibitors [SSRIs] that can lead children to commit suicide or other violent acts.

According to the American Hospital Formulary Service Drug Information 2005, the “FDA now states that it has determined that antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with major depressive and other psychiatric disorders.”

Dr Ann Blake Tracy, is the executive director of the International Coalition for Drug Awareness and the author of “Prozac, Panacea or Pandora: Our Seratonin Nightmare.”

She testified at a February 2004, FDA hearing on the adverse effects of SSRIs, and said, “Research on serotonin has been clear from the very beginning that the most damaging thing that could be done to the serotonin system would be to impair one’s ability to metabolize serotonin. Yet that is exactly how SSRI antidepressants exert their effects.”

Tracy said that for decades research has shown that impairing serotonin metabolism will produce numerous health problems including “pains around the heart, difficulty breathing, tension and anxiety which appear from out of nowhere, depression, suicide — especially very violent suicide, hostility, violent crime, arson, substance abuse, psychosis, mania,” and the list goes on and on.

“How anyone ever thought it would be ‘therapeutic’ to chemically induce these reactions is beyond me,” she said.

In one study reviewed by the FDA panel, in a pool of 931 depressed patients taking SSRIs listed on the TMAP, versus 811 depressed patients taking a placebo, there were 52 suicidal acts by people on the SSRIs versus 18 on placebo.

The drug companies withheld the studies that showed the drugs were basically ineffective on kids and that they were in fact dangerous. Most of the studies that have surfaced over the past couple years were unearthed during the discovery process of recent law suits against drug companies.

Pediatrician, Dr Karen Effren, questions whether the TMAP list should be used at all. “If data is withheld about the dangers or lack of effectiveness of the new psychiatric drugs, why should physicians believe and carry out the recommendations of the New Freedom Commission for treatment, such as the Texas Medication Algorithm Project (TMAP) that uses those drugs as paid for the state incentive grants?”

These same sentiments had already been expressed in January 1999, by Peter Weiden MD, who was one of the participants on the original panel that approved drugs to be on the TMAP list, when he openly criticized the process in the Journal of Practice in Psychiatry and Behavioural Health.

Weiden pointed out the fact that drug company money was involved in the approval of the list. “Another problem is potential bias from funding sources. The 1996 Guidelines were funded by Janssen (makers of Risperidone [Risperdal]) and most of the guidelines’ authors have received support from the pharmaceutical industry. This potential conflict of interest may create credibility problems, especially concerning any recommendations supporting the use of atypical antipsychotics.”

Other drug companies besides Janssen were involved in the creation of the list. And drug company money was also used to grease the palms of politician who would ultimately have to approve the TMAP scheme.

For instance, Eli Lilly helped fund the guidelines and also has well-known ties to both Bush administrations. After Bush Sr left the CIA in 1977, he became a member of Lilly’s board of directors. When he left the company to become Reagan’s VP in 1980, he forgot to mention that he still owned stock in the company at the same time that he was lobbying for tax breaks for Lilly, even though it manufactured drugs in Puerto Rico.

Bush Junior made Eli Lilly CEO, Sidney Taurel, a member of the Homeland Security and his former director of the Office of Management and Budget, Mitch Daniels, was also a former senior vice president of Lilly.

In the 2000 election the company contributed over $1.5 million to political candidates, with over 80% going to Bush and the Republican Party.

According to the Center for Responsive Politics, in his 2 bids for the presidency, Bush has been the number one recipient of either party for campaign donations from the pharmaceutical industry. The same Robert Wood Johnson IV, who has ties to the foundation that funded the TMAP, is also heir to the Johnson & Johnson fortune, and raised over $100,000 for Bush’s 2000 campaign, and over $200,000 for campaign 2004.

The Robert Wood Johnson Foundation also helped fund the Illinois Children’s Mental Health Task Force, which produced the report that the Illinois’ Children’s Mental Health Act of 2003 is based on, according to investigative reporter Rhonda Robinson.

The Illinois version of the TMAP list, is IMAP and it is already in place in 23 Illinois counties, Robinson reports.

Tax Dollar Funded Drug Pushers

Let there be no mistake about it, kids sent to shrinks will end up on drugs. In 2002, a survey of recently trained child psychiatrists found that only one in 10 children in their practices did not receive a medication. See Stubbe DE, Thomas WJ: A survey of early-career child and adolescent psychiatrists, J Am Acad Child Adolesc Psychiatry 2002.

A recent review of prescription data for 300,000 children ages 19 and younger, by Medco Health Solutions in 2004, concluded that for the first time in history, spending for medications for childhood behavior problems eclipsed expenditure for any other drug category, including antibiotics.

The final draft of the Illinois plan issued this month wants to: Promote effective use of Medicaid’s Early Periodic Screening, Diagnosis and Treatment benefit in Illinois to support voluntary screening of children ages birth to eighteen years, and wants to “Clarify for providers the diagnoses that create eligibility for children to obtain Medicaid services.”

I wonder how many people are curious as to what might be in store for the kids they want to screen at age 0. To answer that question, an investigation of the drugs being prescribed to Illinois kids on Medicaid might be helpful.

On April 25, 2005, the headlines of the Ohio Columbus Dispatch read: DRUGGED INTO SUBMISSION, EVEN BABIES GETTING TREATED AS MENTALLY ILL, Doctors prescribed sedatives and powerful, mood-altering medications for nearly 700 Ohio babies and toddlers on Medicaid last summer, according to a Dispatch review of records.

An investigation by the Dispatch revealed that at least 696 Ohio children who were newborn to 3 years old received mental-health drugs paid for by Medicaid in July 2004. Hydroxyzine was prescribed most often, with about three-quarters of the kids on it. The drug, a long-acting antihistamine, relieves itching caused by allergies, controls vomiting and reduces anxiety, but is given to young children most often for its sedative effects.

In addition, more than 90 kids were on another antihistamine, 48 were taking anti-anxiety medication and 28 were prescribed antidepressants, including the SSRIs Paxil, Prozac and Zoloft. Twenty-seven received Valium, and 18 were on antipsychotics.

This revelation set off alarms in Ohio. “It’s troubling,” said John Saros, executive director of Franklin County Children Services. “How do doctors even determine that a 2-year-old is anxious? There’s a reason they call it the terrible twos.”

All total, nearly 40,000 Ohio children on Medicaid were taking drugs for anxiety, depression, delusions, hyperactivity and violent behavior when the investigation was conducted July 2004, according to the Dispatch.

Illinois’ new program keeps stressing that treatment should be funded by Medicaid. That means drugs folks. Over-drugging kids on Medicaid in Ohio is not an isolated practice. Its happening all over the country.

On January 15, 2005, the Miami Herald reported that nearly 1,900 children under the care of Florida’s child welfare system are taking antidepressant drugs, despite a strong federal warning that such medications are linked to an increased risk of suicidal thinking.

Similar findings held true in Tennessee for kids covered by the State insurance program. A study conducted in 2004 by Dr William Cooper, an associate professor of pediatrics at Vanderbilt University in Nashville, determined that the use of antipsychotic drugs among low-income children in Tennessee had nearly doubled between 1996 and 2001.

Cooper’s report, published in the August 3, 2004 issue of the Archives of Pediatric Adolescent Medicine, found that young people who are not psychotic are being prescribed antipsychotic drugs for which there was no data on safety or effectiveness.

The study revealed that the proportion of TennCare children who were prescribed antipsychotics nearly doubled in six years. The most dramatic increases were among those aged 13 to 18 (116%) and those 6 to 12 (93%). Cooper also found use among preschool children had increased by 61%.

If the Illinois Governor signs the new law on June 30th, in addition to children, all pregnant women will be screened for depression during pregnancy and for up to 1 year following a baby’s birth. The treatment for depression mandated by the IMAP drug list will be the SSRI antidepressants even though new studies indicate that SSRIs taken by pregnant women can have serious adverse affects on the unborn fetus.

“Newborn babies could be at risk of suffering withdrawal symptoms if their mothers are prescribed antidepressants during pregnancy,” according to Reuters on February 4, 2005.

Professor Emilio Sanz of the University of La Laguna in Tenerife, Spain, conducted a study that showed that SSRIs can cause convulsions, irritability, abnormal crying and tremors in newborn babies.

For the study, Professor Sanz and his team of researchers searched the World Health Organization database from 72 countries for the adverse drug reactions associated with the use of SSRIs, Reuters reported.

Karen Hayes thinks the whole plan stinks. “Proposing that state government set mental health competency standards for all Illinois pregnant women and children to age 18 stuns human sensibilities,” Karen Hayes wrote, “this proposal calls for collection of mental health data of women and children, together with bureaucratic linkage of this information.”

She’s got that right because according to the plan, the State of Illinois will: Improve accountability, data tracking and reporting for children’s mental health in relevant programs and services and will (1) Institute contract and monitoring changes to increase the accountability of current children’s mental health providers; (2) Develop a statewide data tracking and reporting system to collect information on key indicators of children’s social and emotional development, and mental health status; (3) Develop policies and protocols for the sharing of databases among relevant state and local agencies; (4) Explore the development of uniform reporting forms and test in select programs for the tracking, reporting and planning of services.

Follow The Tax Dollars

The task force says it wants to maximize the use of Medicaid/KidCare by streamlining enrollment, capitalizing on federal reimbursement and implementing key cost-saving strategies, with savings deposited into a Children’s Mental Health Fund.

It wants to (1) Improve Medicaid reimbursement for prevention, early intervention and treatment services; (2) Recognize diagnoses for young children described in DC:0-3 and pay for mental health services for children with any of these diagnoses; (3) Clarify for providers the diagnoses that create eligibility for children to obtain Medicaid services.

Translation: That means to make sure “treatment” (aka pills) will be paid for, people will be trained to only diagnose kids with disorders that are covered Medicaid.

The task force plan leaves no funding stone unturned. It even wants to “Change the Illinois KidCare and Medicaid eligibility procedures to allow for self-attestation of a family’s financial circumstances in lieu of current financial documentation requirements,” which means all I have to do is swear I’m poor to qualify for Medicaid in Illinois.

Drug companies smell the tax dollars and they want these Illinois kids. Over 2 million children were enrolled in Illinois public schools, pre-K through 12th grade, during the 2001-02 school year. Over 960,000 children were enrolled in Medicaid and KidCare in 2002, and a recent study in Chicago claimed that nearly 50% of inner-city adolescents demonstrated signs and symptoms of depression.

So lets do the math and see how much the psychiatric-industrial complex stands to gain. The plans says to: Ensure that all children enrolled in Medicaid receive periodic developmental screens … as mandated under the Early and Periodic Screening Diagnostic Treatment program.

Lets say the initial diagnostic visit to the shrink costs $150, what’s 150 times 960,000?

The report said 50% of Chicago inner city kids were depressed so we’ll use that percentage for the kids on Medicaid. Half of 960,000 means 480,000 kids are set to be prescribed anti-psychotic drugs right from the get go.

Off hand I don’t know how much all the different drugs cost, but I have personal knowledge that the cost of Risperdal in 2001, was close to $500 for a 30 day supply.

In 2001, The Miami Herald published a series of stories about the common use of Risperdal among children in state care. Child-welfare advocates said the drug routinely was being used by foster care providers as a ”chemical restraint” on children whose unruly behavior was a frustration to caretakers.

Risperdal is on the IMAP list as the leading drug used to combat schizophrenia and other types of psychotic disorders, and earns Janssen about $2.1 billion in annual sales. The drug is prescribed to more than 10 million people worldwide, according to the Herald.

I suspect a heavy-duty calculator will be needed to calculate dollar amounts for the potential cost of Risperdal prescriptions to the tax payers of Illinois.

Tax Payers May Foot Entire Bill

No doubt about it, the promoters of this scheme are looking to grab tax dollars from every public trough known to man. The plan lists a host of public funding sources to be examined and includes: Medicaid and SCHIP, the Social Services Block Grant, Temporary Assistance for Needy Families, the Child Care and Development Fund, the Title V Maternal and Child Health Services Block Grant, Parts B (Special Education) and C (Early Intervention) of the Individuals with Disabilities Education Act (IDEA), Juvenile Justice, and state funding sources.

In her opinion piece, Karen Hayes questioned the feasibility of such a large public funded program, “Our government bureaucracies continue to struggle with the job of tending to the social needs of needy Illinois families, and … trying to educate our children in basic academics. How is it that these same bureaucracies can now be asked to take on the additional role of being the mental health evaluator and caretaker of all pregnant women and children in Illinois?”

“At a time when budget concerns are on the front pages of most Illinois newspapers,” Karen wrote, “we are being asked to give input to one of the costliest expansions of government and bureaucracy we have seen in recent years.”

“In summary,” Hayes said, “it is neither beneficial to children, nor to taxpayers, to ask government bureaucracies to set competency standards for mental health. With some amount of lightheartedness, may I propose that the mental health of the perpetrators of this concept be evaluated?”

Another parent agrees with her. “The Illinois Legislature ought to have their own heads subjected to adolescent mental health screening for even considering passing such legislation,” said Jack Kime, in a June 13, 2005 letter to the Illinois Leader, “If there is anything more dangerous than having the government put such a program in place, I don’t know what it might be,” he said.

Filed under: 2005, antipsychotics, Bush, drugging children, FDA, Illinios, Johnson and Johnson, NFC, pregnant, RWJF, SSRIs, suicide, TeenScreen, TMAP, Zero to Three

Tracking the American Epidemic of Mental Illness – Part II

Evelyn Pringle June 7, 2010

Tax dollars are being used to fuel the American epidemic of mental illness by promoting the preemptive drugging of persons supposedly at risk of developing mental disorders, to the great benefit of the pharmaceutical industry.

In March 2010, the US Department of Health & Human Services Substance Abuse & Mental Health Service Administration Center for Mental Health Services announced $16.5 million in funding for “Mental Health Transformation Grants,” one of SAMHSA’s services grant programs.

“In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses,” the agency noted.

Applications were required to implement evidence-based or best practices that would create or expand capacity to address one or more of five Strategic Initiatives, including: “Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches.”

An evidence-based practice, or EBP, refers to approaches to prevention or treatment that are validated by some form of documented research evidence. As an example of a practice that could be implemented, SAMHSA listed under “Prevention and Wellness: Early Intervention,” the “Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP),” along with a link to its website http://www.changemymind.org/.

EDIPPP is a national program replicating the “Portland Identification and Early Referral,” or “PIER,” a treatment research program at the Main Medical Center, in Portland, Maine.

On a webpage for PIER on the Center’s Website, under “Project Overview,” it states: “The goals are to improve outcomes and prevent the onset of the psychotic phase of illnesses like Bipolar Disorder, Major Depression, and Schizophrenia.”

“This is the first program in the United States to identify the entire population of at risk young persons and offer them treatment,” PIER said in a September 26, 2005 press release.

EDIPPP was funded through a $14.4 million million grant for the “National Demonstration of Early Detection, Intervention and Prevention of Psychosis in Adolescents and Young Adults,” from the Robert Wood Johnson Foundation, and is “designed to prevent psychosis in teens and young adults,” according to an April 10, 2007, announcement on RWJF’s launch of the program.

“The national program is expanding PIER’s success during the past seven years in identifying and treating young people experiencing subtle and early symptoms that herald the onset of serious mental illness,” a November 2007 report in Behavioral Healthcare, by Dr James Maier, a research psychiatrist with PIER, notes.

EDIPPP works with people between the ages of 12 and 25, with an average age of persons entering the program between 15 and 16.

“Widespread dissemination of this early intervention model throughout the United States offers tremendous hope and optimism for combating some of the most devastating and costly illnesses that can afflict young people and their families,” Maier claims.

The RWJF grant set up additional EDIPPP sites in Sacramento, California; Salem, Oregon; Ypsilanti, Michigan; and Glen Oaks, New York. A site in Albuquerque, New Mexico was added in 2008.

RWJF also funds a booklet for professionals, on how to prevent mental illness with early detection titled, “Recognizing and Helping Young People at Risk for Psychosis: A Professional’s Guide,” which can be downloaded free off the internet.

From the start, PIER has always been primarily funded by RWJF, according to its website. However, on October 13, 2003, Mental Health Weekly reported that the program had received a $3.9 million grant from the National Institute of Mental Health, and a parallel $2 million grant from the Center for Mental Health Services intended for a related program in early identification of non-psychotic disabilities.

In Portland, young people typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER’s work, visited the PIER Website (http://www.preventmentalillness.org), and are familiar with the early warning symptoms that suggest the onset of a psychotic illness, according to the report in Behavioral Healthcare.

Mental Illness According to PIER

In a fact sheet posted to “Dispel the Myths,” the PIER website claims that, “Mental disorders are as easy to diagnose as asthma, diabetes, and cancer.”

“Treatments are effective 60%-80% of the time, success rates that meet or exceed success rates for cutting edge treatment for heart disease,” the sheet states.

“In many cases, PIER does use medications,” the Websites says. “We believe that some of the newer medications effectively improve thinking and combat early symptoms.”

“Research suggests these medications may have a protective effect against changes in the brain that cause mental illness,” it reports.

Under costs, it reads: “For now, services provided by PIER staff are supported by grants. However, if certain medications, medical tests, or neurological assessments are ordered, there will be a charge.”

The PIER program was founded in 2000, by Dr William McFarlane, and after 10 years in operation, on May 28, 2010, the ChangeMyMind website listed only two “case studies and impact stories that illustrate the effectiveness of the Early Detection and Intervention for the Prevention of Psychosis Program.”

Medicated for Life

Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson, the parent company of the Robert Wood Johnson Foundation. These prescriptions are off-label because antipsychotics are not FDA approved to “prevent” mental illness in any age group.

An August 2008 article, by Charles Schmidt in Discover Magazine, highlighted the PIER program with a byline that stated: “A new mix of therapy and medication may stave off psychosis among teens at risk.”

Schmidt discussed the case of Camila (not her real name), who entered the program in September 2001, when she was 14. “Camila and her family stuck with PIER for the four-year treatment program, which ended formally in 2005, and still keep in touch with counselors there,” he reports.

However, “Camila’s health still hinges on antipsychotic medication,” Schmidt says. “In the summer of 2007 she went off the drugs for a spell and her strange feelings returned.”

He notes that her reliance on antipsychotics raises issues. “On the one hand, it shows that the threat of psychosis hasn’t really been removed, it’s just been held in check.”

“What we hope is that the benefits of treatment will be lifelong,” McFarlane says in the article. “We don’t have any empirical evidence to support that yet, but what we’ve seen is that young people who still haven’t converted to psychosis after about three years of our treatment don’t seem to be at much risk.”

While he suggests that over time, some patients may be able to go off medications, McFarlane acknowledges that PIER hasn’t developed a plan for managing that process, Schmidt reports.

“As to when or if they can go off medication, that’s hard to say,” he told Schmidt. “I think many of our patients don’t feel a need to stop; they certainly don’t feel oppressed by it. At a certain point it becomes a personal choice.”

A fortune can be made from these life-long antipsychotic customers. In April 2010, the price for one box of Invega, at a middle dose, was $1,373 at DrugStore.com. Risperdal went for $788 per 90 pills. The cost was $1,395 for 100 tablets of Abilify. Seroquel cost $997 per 100. One-hundred capsules of Geodon sold for $918 and Zyprexa cost $1,523 for a hundred 10mg pills.

In 2003, McFarlane told Mental Health Weekly that with about 3% of the population at risk for a serious mental illness, Greater Portland could expect about 75 young people to develop a disorder each year.

RWJF Front Group

The founder of RWJF, Robert Wood Johnson, was chairman of Johnson & Johnson for over 30 years, from 1932 to 1963, as a member of the drug maker’s founding family. Throughout the years, the majority of the Foundation’s money has come from investments in J&J stock. RWJF’s board of trustees has always been stacked with the drug company’s executives. For instance, current and past trustees have held positions at J&J such as President, CEO, Vice President, Chairman of the Board, and Treasurer, and have served along side another family heir on the board, Robert Wood Johnson IV.

RWJF is listed in a Medicaid fraud lawsuit, filed against J&J by whistleblower, Allen Jones, a former federal fraud investigator, and joined by the Texas attorney general, as providing funding for illegal marketing schemes to increase the off-label sales of Risperdal, including funding the development of the “Texas Medication Algorithm Project (TMAP),” which required doctors to prescribe the newest, most expensive antipsychotics, antidepressants, anticonvulsants, and ADHD drugs to patients covered by public programs, like Medicaid and Medicare, who were diagnosed with mental disorders, and a nearly identical set of child drugging guidelines known as the “Texas Children’s Medication Algorithm Project (CMAP).”

In addition to Risperdal and Invega, J&J also markets the ADHD drug Concerta, and Topamax, an anticonvulsant.

A May 11, 2005, report by RWJF on the results of the funding of TMAP grants totaling $2,389,581 to the University of Texas Southwestern Medical Center at Dallas and a grant of $353,747 to the Texas Department of Mental Health and Mental Retardation, describes the supposed “Problem,” that led to the creation of the TMAP drugging guidelines as:

“In the 1980′s and 1990′s, as pharmaceutical companies began producing new and more efficacious medications to treat people with serious mental disorders such as depression, bipolar disorder, and schizophrenia, the question arose of how to choose the most appropriate treatment options. Concerns about wide variation in prescribing practices by physicians and complaints from consumer advocates about the negative consequences of this variation spurred the creation of evidence-based guidelines and medication treatment algorithms.”

The “Contacts” for the grants listed in the report, were Dr A John Rush, for the University, and Dr Steven Shon for the state of Texas. Shon was fired in October 2006, after the Texas attorney general determined that J&J had improperly influenced him to make Risperdal a preferred drug on TMAP. In 2008, Rush was added to a list of psychiatric academics who failed to disclose all the payments they received from drug companies, by Senator Charles Grassley, as part of an investigation conducted on behalf of the US Senate Finance Committee, which oversees Medicaid and Medicare spending.

As a main component of the off-label marketing schemes, the lawsuits against the antipsychotic makers allege that the drug companies “seeded” the medical literature with reports and papers purporting to be written by “experts” when they were actually ghostwritten with the names of experts attached after the fact.

In its report on the TMAP grant results, RWJF boasts that: “More than 50 articles on the Texas Medication Algorithm Project have appeared in the Journal of Clinical Psychiatry, Psychiatry Research, Managed Care, Health Services Research, Journal of the American Academy of Child and Adolescent Psychiatry and other peer-reviewed journals.”

“Over the next two years, Project Directors Rush and Shon and their colleagues plan to publish additional articles on other areas of interest,” the report said.

On August 18, 2008, a Dallas Morning News headline read: “Conflict of interest fears halt children’s mental health project,” in reference to the Children’s Medication Algorithm Project. “A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News wrote.

To date, four of the five atypical makers have settled fraud charges involving the illegal off-label marketing of antipsychotics, including for use with children. Eli Lilly paid $1.4 billion for Zyprexa, Bristol-Myers Squibb’s fine was $515 million for Abilify, Pfizer paid $301 for Geodon, and AstraZeneca just forked out $520 million for Seroquel.

But the fines are merely chocked up to the cost of doing business. For instance, although AstraZeneca paid a whopping $520 million fine, Seroquel had sales of $4.9 billion in 2009, with more than half coming from the US. Overall, antipsychotics were the top-earning class of drugs in the US, in both 2008 and 2009, with sales of $14.6 billion in 2009, according to IMS Health.

J&J is the only atypical maker that has not settled the off-label marketing charges against it – yet. However, two units of J&J “will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax,” according to Bloomberg news on April 29, 2010.

Also, over the past 2 months, J&J’s McNeil division has recalled over 40 varieties of child and baby medications after the FDA found massive safety and manufacturing violations at a plant in Fort Washington, Pennsylvania, including formulations of Tylenol, Motrin, Zyrtec and Benadryl. The FDA also found problems with “strength, quality and purity.”

The FDA’s inspection report notes that J&J received about 46 consumer complaints “regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010.” J&J had knowledge of problems since May 2009, which means it was allowing children and infants to ingest potentially poisonous drugs for a year before the product recall took place.

Time Magazine as Promoter

On June 22, 2009, the RWJF website posted a link to download the full text of an article in Time Magazine, by John Cloud titled, “Staying Sane May Be Easier Than You Think,” who reported: “The most exciting research in mental health today involves not how to treat mental illness but how to prevent it in the first place.”

“In fact,” Cloud said, “many mental illnesses — even those like schizophrenia that have demonstrable genetic origins — can be stopped or at least contained before they start.”

“This isn’t wishful thinking but hard science,” he claimed.

The article discussed a report by the National Academics, “an organization of experts who investigate science for the Federal Government,” nearly two years in the making, “on how to prevent mental, emotional and behavioral disorders.” A quick check found one of the sponsors of the National Academies to be RWJF.

“The report concludes that pre-empting such disorders requires two kinds of interventions,” Cloud said, “first, because genes play so important a role in mental illness, we need to ensure that close relatives (particularly children) of those with mental disorders have access to rigorous screening programs.”

“Second,” he noted, “we must offer treatment to people who have already shown symptoms of illness (say, a tendency to brood and see the world without optimism) but don’t meet the diagnostic criteria for a full-scale mental illness (in this case, depression).”

“Some prevention programs even prescribe psychiatric medications, including antipsychotics and antidepressants, to people who aren’t technically psychotic or depressed,” Time reported.

“This is a big concern,” Joseph Rogers, founder of the Philadelphia-based National Mental Health Consumers’ Self-Help Clearinghouse told Cloud. “Because, gee, if you miss, you can really do more harm with some of these drugs than good.”

“But those who contributed to the National Academies report say preventing the suffering of people with mental illness is worth the risk of some false positives, partly because of the enormous cost of treating mental illness after it’s struck,” Cloud reported.

The article profiled PIER and McFarlane, who was described as “one of the world’s top authorities on preventing mental illness.”

According to Time, the “National Institute of Mental Health is funding a trial of McFarlane’s work, and while he is still writing up his data for publication, his anecdotal results are promising: most of the kids are so far avoiding a first psychotic episode.”

Preemptive Drugging Unsupported

In a 2008 paper titled, Atypical Antipsychotic Agents For the Schizophrenia Prodrome: Not a Clear First Choice,” published in the “International Journal of Risk & Safety in Medicine,” Dr Stefan Kruszewski, a psychiatrist, and Dr Richard Paczynski, a neurologist, both from Harrisburg, Pennsylvania, explain that, “Pharmacologic intervention at the earliest stages of suspected psychotic illness is an intuitively appealing concept and a logical extension of the current approach to many other diseases of the central nervous system.”

“However,” they report, “a critical analysis of the results of structured clinical investigations which have explored the use of ATAPs for new-onset psychotic symptoms raises safety concerns and does not support pre-medication in this setting as a preventive strategy.”

“Over the past several years,” the paper states, “a voice has emerged in the international psychiatric community recommending early prescription of the atypical antipsychotic agents (ATAPs) for adolescents and young adults who appear to show signs consistent with a schizophrenia prodrome. Early use is predicated on the possibility that ATAPs may prevent progression to full-blown psychotic illness in this high-risk population. “

“This trend has been encouraged despite a paucity of data which clearly support the effectiveness of these agents for this indication, and despite evidence of adverse side effects including,” the authors note.

These circumstances prompted their literature review, “focusing on the five published studies that have explicitly addressed the preventative efficacy of the most widely prescribed ATAPs in structured (i.e., non-anecdotal) clinical settings.”

In the summary and conclusion section of the paper, the authors report that the results from the available controlled trials reviewed are in line with several of the conclusions of the naturalistic study by Cornblatt et al. “That is, early prescription of ATAPs to adolescents and young adults seeking medical attention for prodromal psychotic symptoms is associated with high rates of medication non-adherence.”

“Additionally,” they say, “the introduction of ATAPs was not associated with reduction in the rate of conversion to formal psychosis beyond that explainable by chance and/or the introduction of bias secondary to baseline imbalances, inadequate blinding or even differential psychosocial supports.”

“We suggest caution in making any assumptions that justify changes in prescription-writing behavior when it involves patients who are at high risk for developing long-term psychotic illnesses but have never demonstrated sustained psychosis (psychotic illness by DSM-IV criteria),” Kruszewski and Paczynski advise.

“This would include but is not limited to persons with suspected schizophrenia prodrome,” they add.

“Even in the hands of experienced investigators using detailed screening protocols in controlled settings, only one-quarter to one-third of high-risk patients converted to full-blown psychosis,” they report.

“Consequently,” they warn, “if early use of ATAPs continues as a quasi-standard of care for new-onset psychotic symptoms, a large majority of these often young individuals will be exposed unnecessarily to poorly defined but likely substantial risks, including but not limited to obesity, hyperlipidemia, metabolic syndrome, increased rates of type II diabetes mellitus and extrapyramidal syndromes, both acute and chronic.”

“Considerations of safety must come first when the preventative efficacy of these agents remains so poorly defined,” they conclude.

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 2010, antipsychotics, drugging children, EDIPPP, front groups, Johnson and Johnson, PIER, preemptive drugging, prodome, RISPERDAL, Robert Wood Johnson Foundation, RWJF, SAMHSA, TMAP

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