Tracking the American Epidemic of Mental Illness PartPart II

by Evelyn Pringle / June 4th, 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.

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, 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, “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.

• Read Part
I
.

• Part III of this series will highlight the Psychiatric Industrial
Complex as the driving force behind the American Epidemic of Mental
Illness.

• This series is sponsored by the International Center for the
Study of Psychiatry and Psychology
.

Evelyn Pringle is an investigative journalist
focused on exposing corruption in government and corporate America. She
can be reached at: evelyn-pringle@sbcglobal.net.
Read other
articles by Evelyn
, or visit Evelyn’s website.

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