St. Pete Times Exposes BILLION DOLLAR PSYCH DRUG SCAM - Please helpwith your letters!

St. Pete Times Exposes BILLION DOLLAR PSYCH DRUG SCAM - Please help
with your letters!

As Florida legislators try to slash the state budget because of
decreased tax revenue, and as various agencies brace for deep cuts in
funding, here's a number to keep in mind: $1.1-billion

That is what Florida taxpayers spent in the last 5 years on the "new"
antipsychotic drugs. (Abilify, Geodon, Risperdal, Seroquel and
Zyprexa)

These "new" antipsychotics (aka atypicals) at $8 per pill are no more
"effective" than the older (typical) antipsychotic drugs such as
Haldol
and Thorazine at 5 cents per pill and have just as many horrendous
side
effects.

The below St. Petersburg Times article is an important one. Please
help with your responses.

Here is a couple of points you might consider when responding with
your
words of wisdom:

A. Legislators are looking to cut funding. The Atypical
Antipsychotics
are a great place to start. Over 50% of the antipsychotics for
Medicaid young children in Florida are being used for "ADHD" - a use
not approved by the FDA. Cut that!

B. Rajiv Tandon, psychiatrist, should be fired. He is the Chief
Psychiatrist, State of Florida. Evidence available to date reveals
that
previous to working for the Department of Children and Families he was
on the payroll in some fashion of every atypical antipsychotic maker.
It was Tandon who pulled together various psychiatrists (all pharma
funded) to form a consensus on which antipsychotic drugs should be
used
in Florida. Only pharma funded psychiatrists who supported the "new"
antipsychotics were invited. No one was invited from other camps who
dispute the "superiority " of the new antipsychotic drugs.

1. Send your letter to the editor:
2. Send it to Florida Governor Charlie Crist:


and cc Bob Butterworth
, Secretary of the
Florida Department of Children and Families.
3. If you're from Florida, send it to your own Florida State House
Rep
- find him/her he http://tinyurl.com/a48hb
http://tinyurl.com/a48hb find your zip code plus four there.
4 If you're from Florida, send it to your own Florida State Senator
-
find him/here he http://tinyurl.com/3twkxc
http://tinyurl.com/3twkxc

_____

St. Petersburg Times
Drug research: To test or to tout?
In the 1990s, drug companies trumpeted a new class of drugs, atypical
antipsychotics: better treatment, fewer shakes. They wanted the Food
and
Drug Administration to let them say their drugs were safer and more
effective than Haldol. But the FDA said no.
By Robert Farley
Saturday, April 12 (online)
http://www.tampabay.com/news/health/article454391.ece
http://www.tampabay.com/news/health/article454391.ece
Sunday, April 13 (paper) http://www.psychsearch.net/spt.pdf
www.psychsearch.net/spt.pdf (check out all the photos and graphics)

In the mental institution in One Flew Over the Cuckoo's Nest, Nurse
Ratched is obsessed with keeping order on the ward. She dispenses
pills
that sedate the residents into near zombies.

The novel was published in the 1960s, when Haldol and Thorazine were
the
drugs of choice to fight schizophrenia. They calm patients but also
can
cause uncontrollable shakes.

In the 1990s, drug companies trumpeted a new class of drugs, atypical
antipsychotics, that they billed as a dream solution: better
treatment,
fewer shakes.

Atypical antipsychotic drugs: left to right, ZyPREXA, SeroQUEL,
ABILIFY
and RISPERDAL.
http://www.tampabay.com/multimedia/archive/00018/
tb_atypicals_450_18990
a.jpg
[Martha Rial - Times]
Atypical antipsychotic drugs: left to right, Zy prexa, Seroquel,
Abilify
and Risperdal

They wanted the Food and Drug Administration to let them say their
drugs
were safer and more effective than Haldol. But the FDA said no,
because
the drug companies had submitted biased studies, according to
documents
obtained by the St. Petersburg Times.

It happened when Eli Lilly and Co. asked for approval of Zyprexa, and
again when Janssen asked for approval for Risperdal.

The FDA said Risperdal could come to market. But there was a caveat:
"We
would consider any advertisement or promotion labeling for Risperdal
false, misleading or lacking fair balance ... if there is a
presentation
of data that conveys the impression that (Risperdal) is superior to
haloperidol (generic for Haldol) or any other marketed antipsychotic
drug product with regard to safety or effectiveness."

Believing they had invented better drugs, not to mention the
opportunity
for outsized profits, the drug companies were undaunted by the FDA's
red
light.

Prohibited from touting their drugs as better? No problem. They paid
academics and doctors who said it for them.

The companies funded study after study that found - little surprise -
the new drugs were better and safer. State by state, the companies
funded committees that set treatment guidelines that decreed atypicals
should be the drugs of choice.

Despite the FDA ostensibly reining them in, the drug companies remade
the marketplace.

Atypicals have become the overwhelming drug of choice, and not just
for
schizophrenia and bipolar disorder, the crippling illnesses they were
approved for. Doctors commonly prescribe them to treat anxiety,
depression and ADHD in children. They're even given as sleep aids.

The new drugs can cost 20 times as much as the old, so taxpayers pay a
small fortune in Medicaid expenses. In Florida alone in the past five
years, taxpayers spent more than $1.1-billion on the new antipsychotic
drugs.

The drug companies, meantime, enjoy billions in profits.

.. . .

Allen Jones knew the instant he was destined to be a whistle-blower.
He
says it was when his boss told him: "Quit being a salmon. Quit
swimming
against the stream with the pharmaceutical case."

It was a fluke that the case landed on his desk, and it was a fluke
that
he was even working in the office of the Inspector General in
Pennsylvania.

Twice divorced, a single dad with custody of his kids, he had been
swinging a hammer, doing rehab work on houses and flipping them. He
figured signing on with the state would give him financial security
and
early retirement.

But life has a way of veering from script, and in 2002, he happened to
draw a case where the state's chief pharmacist reportedly was earning
money on the side - from a pharmaceutical company.

Jones learned that the chief pharmacist headed a government panel that
would decide which drugs doctors should reach for first to treat
severe
mental illnesses in Pennsylvania. All of the drugs being touted as
front-line were brand new, patented, and therefore exceptionally
expensive. Yet some experts that Jones talked to said the new drugs
were
no better than the old ones.

"It didn't pass the smell test," he said. "There was too much
opportunity for fraud."

He suspected that pharmaceutical companies promoting their new drugs
were "buying off" state officials in positions to influence the
prescription practices of doctors across Pennsylvania. Taxpayers were
paying the freight for these high-priced drugs.

That's when Jones says his boss told him not to play the part of the
salmon. Drop it, the politicians will never stand for a real
investigation: "I was told point-blank, 'These pharmaceutical
companies
write checks on both sides of the aisle.' "

Jones ended up taking his concerns to the press. It wasn't long before
a
security guard escorted him from the building and into the ranks of
the
unemployed.

.. . .

The idea of establishing state guidelines for prescription practices
originated in Texas in 1996, under an ungainly name:

The Texas Medications Algorithm Project. TMAP for short.

The goal was to bring together some of the best minds in the field to
reach consensus on how best to treat schizophrenia and bipolar
disorder.
TMAP would tell Texas doctors: Start with this drug, and if it doesn't
work, try this one. If a drug made the top of the list, the
manufacturer
stood to make millions.

The atypical drug companies stacked the deck: TMAP was seeded with a
$1.6-million grant from the charitable arm of the company that owns
Jannsen, which makes Risperdal. The panel was packed with doctors and
academics who were paid on the side from the companies that make
atypicals.

Proponents of guideline committees say they discourage unproven
practices, such as prescribing combinations of several antipsychotics.

Spearheading TMAP was Steven Shon, the Texas Health Department's
medical
director for behavioral health. A state employee, he was not allowed
to
accept money from the pharmaceutical companies.

He resigned amid an investigation that revealed he was taking money
from
Janssen. By then, with Shon's help, the Texas guidelines model had
been
exported to more than a dozen states, including Florida.

The Florida Behavioral Health Collaborative was the brainchild of Eli
Lilly and Co., which proposed it in 2004 and, with other drug
companies,
gave the state $10-million to create it.

According to Lilly spokeswoman Janice Chavers, the goal was not to
help
the company's profit margin, it was to give patients the best ca
"Patients always must be the top priority. It can't always be about
the
bottom line."

The Florida collaborative convened an expert panel to recommend state
standards for treating mental illness. National scholars were invited
-
all with financial ties to drug companies.

To treat schizophrenia, the panel decided, doctors should try an
atypical first. If that didn't work, they should try a different
atypical. If that still didn't work, they should try a third atypical
or, if they would rather, one of the older generation drugs.

.. . .

Running Allen Jones out of his job only spurred him on. He tracked the
medications guidelines in Pennsylvania - Penn-MAP - back to its
birthplace in Texas.

In 2004, he filed a whistle-blower lawsuit in Texas against Johnson &
Johnson, parent company of Janssen. He said that to boost sales of
Risperdal, Janssen misled Texas health officials, overstating the
drug's
effectiveness and underplaying the risks.

"They got expert opinion to be the deciding factor," Jones said in an
interview. "Essentially, the drug companies could pay people to say
what
the drug companies could not claim themselves," namely that they were
superior to the older generation of antipsychotics.

"It was a concentrated, deliberate attempt to substitute illusion for
science."

A company spokesman denied it. "Janssen has always been committed to
the
highest ethical standards and responsible behavior . and this includes
clear, FDA-approved information about the product's efficacy and
safety
profile.''

Jones was not a lone wolf. The Texas attorney general joined his
lawsuit
in 2006 and demanded the return of tens of millions of taxpayer
dollars.

The still-pending lawsuit has reverberated around the country. Nine
states sued Eli Lilly, four sued Janssen, two sued AstraZeneca. Dozens
more states have teamed in a joint investigation, seeking billions of
dollars in restitution for money they say they overpaid for atypicals
through Medicaid.

Jones, the single dad just looking for a steady job, has morphed into
a
full-time megathorn in the side of pharmaceutical companies. He does
investigative work for law firms making cases against drug companies.
Senators and congressmen call him to talk about big pharma influence.

And Pennsylvania's chief pharmacist, the man Jones was fired for
speaking out about? He was indicted. The charges say that as head of
Pennsylvania's mental health guidelines committee, the pharmacist took
money and other perks from Pfizer and Jannsen, drug companies that
make
atypicals.

Looking back now, Jones is astonished by how few people it took -
academics, psychiatrists, state officials - for the drug companies to
influence state guidelines and bump up their sales by billions of
dollars.

"The marketing was complex, but not complicated," he said. "Divert
attention from the science. Divert attention to the scientists who are
in your pocket."

.. . .

For years, the studies paid for by the drug companies concluded that
atypical antipsychotics are more effective and safer than the older
class.

But when governments conducted independent studies, the findings were
altogether different.

In 2005, the U.S. government funded a $60-million study called CATIE,
short for Clinical Antipsychotic Trials of Intervention Effectiveness.
It tracked a big sample (nearly 1,500 schizophrenics) for a long time
(18 months).

CATIE analyzed the performance of all the atypicals and one of the
typicals, perphenazine.

The two key conclusions: First, the atypicals generally were no more
effective than the older drug. Second, slightly fewer people on
atypicals dropped out of the study due to tremors, but the new drugs
had
their own troubling side effects, chiefly weight gain and diabetes.

What CATIE documented also was showing up in courthouses across the
country: Tens of thousands of people sued Eli Lilly and AstraZeneca,
saying that their drugs, Zyprexa and Seroquel, gave them diabetes and
elevated blood sugar levels. Eli Lilly reports having paid $1.2-
billion
to settle nearly 30,000 lawsuits.

In October 2006, a British government-funded study mirrored the CATIE
findings. Its results, the study said, "refute the hypothesis that the
use of (atypicals) is superior to the use of (typicals) in terms of
quality of life at one year."

How to jibe these independent, government findings against the earlier
studies that said atypicals were safer and more effective?

In a written commentary, the CATIE study's lead author said "the
claims
of superiority for the (atypicals) were greatly exaggerated.

"This may have been encouraged by an overly expectant community of
clinicians and patients eager to believe in the power of new
medications,'' wrote Dr. Jeffrey Lieberman. "At the same time, the
aggressive marketing of these drugs may have contributed to this
enhanced perception of their effectiveness in the absence of empirical
evidence."

The marketing has been a rousing success: Of the prescribed
antipsychotics in Florida last year, 86 percent were atypicals.
Nationally, atypical sales have risen every year, nearly double since
2000.

Dr. Robert Rosenheck, a Yale professor who participated in the CATIE
study, said the science doesn't justify that.

"There was never any evidence that warranted the amount of money we
spend on atypicals," he said. "If you look at it independently, it is
very clear the results say there is no benefit'' to atypicals over
typicals.

Yet the pharmaceutical companies get states to make them the drugs of
choice, he said.

"They leverage every single angle they can to persuade every person to
secure the opinion that their products are superior," Rosenheck said.
"Every possible source of opinion, they use money to establish a
relationship with them.

"The issue is not, 'Were these people influenced?' There is nobody who
is not influenced."

In Minnesota, one of the few states with a law that requires
disclosure
of pharmaceutical company payments to doctors, one report showed that
more than one-third of the state's psychiatrists took money from
drugmakers.

Last year, a nonprofit group funded by 13 states analyzed the academic
studies on atypicals. The Drug Effectiveness Review Project found that
an alarming number of study authors were employed by pharmaceutical
companies.

While academics and doctors often bristle at the suggestion their
opinions could be influenced by pharmaceutical money, another study
confirmed a not-unexpected conclusion: In trials of antipsychotic
medications, the outcome usually favored the drug of the company that
paid for the study.

Rosenheck believes that CATIE and other new studies are starting to
shift the tide in academia - slowly.

"Obviously, there's a certain amount of resistance to admitting, one,
I
was wrong, and two, I was misled by companies who paid me a lot of
money. That's a hard thing for a scientist to acknowledge."

He says states should change their medication guidelines so that the
older class of drugs are used, unless there is a clear reason to use
the
newer ones. For many patients newer may be better, he says, but to
continue the rampant use of atypicals despite the study findings is
bad
science.

"The idea that we could spend $60-million on a study and pay no
attention to it, it's like, let's not pay attention to science and
just
go with marketing."

.. . .

The landscape had changed in the two years since the Florida
Behavioral
Health Collaborative set treatment guidelines favoring atypicals.

The CATIE study had been published. Tens of thousands of patients had
sued drug companies that made atypicals. The academic community was
more
divided about what was best.

Last July, the collaborative convened another group of experts to
revisit whether Florida should rely so heavily on atypicals. Two dozen
mental health professionals met at the Renaissance Hotel at Tampa's
International Plaza.

They gathered in the Kalamata Room, done up in the milquetoast style
of
a classic hotel meeting room: long tables arranged in a square, at
each
seat a glass of water and a name tag.

The bland setting belied the grand stakes: The vote could swing
hundreds
of millions of dollars in pharmaceutical company profits. Cost to
taxpayers, however, had no place in the conversation.

The meeting's two main hosts were Rajiv Tandon, chief of psychiatry
for
the state Department of Children and Families, and Robert Constantine,
head of the Florida Behavioral Health Collaborative.

Both believe in atypicals. In two papers they co-wrote in late 2006
and
early 2007, they said the CATIE study missed the point: The goal is to
create a good antipsychotic effect without the tremors, making
atypicals
the better choice.

Constantine, a research associate professor at USF's mental health
institute, is partly paid through a grant from Bristol-Myers Squibb,
which markets the atypical Abilify.

Tandon, a state employee, is not allowed to accept money from drug
companies. But three years ago, before coming to Florida from the
University of Michigan, he was a paid consultant and on the speaker's
bureau for several drug companies that make atypicals.

It was Tandon who invited the four national experts to be voting
members
on the Florida panel. All are consultants, serve on speakers bureaus
or
get research support from the drug companies that profit from
atypicals.

.. William Glazer, who was brought in as the schizophrenia expert, is
president of Glazer Medical Solutions, a national consortium of mental
health care consultants. He is a consultant to Eli Lilly and
AstraZeneca.

His company Web site makes clear his bias: "Are you interested in
building a case for the value of new atypical antipsychotic
medications?
This section offers a step-wise approach to help providers, family
members, consumers and others advocate for access to these agents."

.. Madhukar Trivedi, a professor of psychiatry at the University of
Texas
Southwestern Medical Center, is a consultant, serves on speakers
bureaus
or receives research money from 24 pharmaceutical companies, including
all the atypical makers.

.. Terence Ketter, a professor of psychiatry and behavioral sciences
and
chief of the bipolar clinic at Stanford University, is a paid
consultant
or a lecturer for all the drug companies that make atypicals.

.. John Greden, chairman of the psychiatry department at the University
of Michigan Medical Center, serves on scientific advisory boards for
five pharmaceutical companies, including two that make atypicals.

Tandon said he selected experts who are knowledgeable, respected
leaders
in their field, with a working knowledge of the medication guidelines
process. Because most experts have ties to the pharmaceutical
companies,
Tandon said, conflicts of interest are inevitable.

"There are clear conflicts of interest," he said. "Everyone is biased.
For someone to say, 'I'm not biased,' they are not truthful or they
are
not introspective."

Given that there is a divide in the academic world about atypicals,
why
not bring in someone from the other camp, maybe somebody from the
CATIE
study, someone who would challenge the existing medications model?

"You could go with extremes," Tandon said. "I didn't think that was
the
way to go," because the point of the process is to reach a consensus.

Atypicals are usually better, he said. "Were the benefits of atypical
medications exaggerated? Absolutely. And was it the pharmaceutical
companies doing that? Absolutely."

Still ... "By no means are the newer medications astoundingly better,
but they are better. If I have a child, I'm not going to start them on
a
typical."

More than a dozen Florida mental health officials sat on the
committee,
many of them adamant that the newer drugs generally offer a better
alternative to the older ones. They said they feared that if they put
the older drugs alongside the newer ones as front-line options, HMOs
might require them to go with the cheaper option.

To treat schizophrenia, the previous expert panel had made atypicals
the
first and second options. For the third option, doctors were left to
decide whether to try a third atypical.

This time around, the group kept atypicals the first option. As a
small
nod to CATIE, the group voted on a recommendation that if that first
atypical failed, a doctor should try either a second atypical or an
older-class, typical drug.

Asked for a show of hands, all were raised in favor.

http://www.tampabay.com/specials/200...-drugs-charts/
at
ypicals-tearsheets.gif

Times researcher Caryn Baird contributed to this report. Robert Farley
can be reached at or (727) 893-8603.

The atypicals

Older generation antipsychotics, called typicals, were prescribed for
schizophrenia and bipolar disorder but often caused Parkinson's-like
shakes. They were mostly replaced in the 1990s with the emergence of
atypical antipsychotics. The new drugs, which work on different brain
receptors, were touted as better and safer. Here are the atypicals now
on the market.

Trade name Drug name Marketed by

Clozaril Clozapine Novartis

Zyprexa Olanzapine Eli Lilly and Co.

Risperdal Risperidone Janssen Pharmaceutica

Seroquel Quetiapine AstraZeneca

Geodon Ziprasidone Pfizer

Abilify Aripiprazole Otsuka Pharmaceutical Co. and Bristol-Myers
Squibb

Invega Paliperidone Janssen Pharmaceutica

_____

26,512 Signatures Against TeenScreen.
http://www.petitiononline.com/TScreen/petition.html
http://www.petitiononline.com/TScreen/petition.html Video:
http://www.youtube.com/watch?v=RfU9puZQKBY
http://www.youtube.com/watch?v=RfU9puZQKBY

"Sir Arthur C.B.E. Wholeflaffers A.S.A." wrote in message
...
St. Pete Times Exposes BILLION DOLLAR PSYCH DRUG SCAM - Please help
with your letters!

As Florida legislators try to slash the state budget because of
decreased tax revenue, and as various agencies brace for deep cuts in
funding, here's a number to keep in mind: $1.1-billion

That is what Florida taxpayers spent in the last 5 years on the "new"
antipsychotic drugs. (Abilify, Geodon, Risperdal, Seroquel and
Zyprexa)

These "new" antipsychotics (aka atypicals) at $8 per pill are no more
"effective" than the older (typical) antipsychotic drugs such as
Haldol
and Thorazine at 5 cents per pill and have just as many horrendous
side
effects.

The below St. Petersburg Times article is an important one. Please
help with your responses.

Here is a couple of points you might consider when responding with
your
words of wisdom:

A. Legislators are looking to cut funding. The Atypical
Antipsychotics
are a great place to start. Over 50% of the antipsychotics for
Medicaid young children in Florida are being used for "ADHD" - a use
not approved by the FDA. Cut that!

B. Rajiv Tandon, psychiatrist, should be fired. He is the Chief
Psychiatrist, State of Florida. Evidence available to date reveals
that
previous to working for the Department of Children and Families he was
on the payroll in some fashion of every atypical antipsychotic maker.
It was Tandon who pulled together various psychiatrists (all pharma
funded) to form a consensus on which antipsychotic drugs should be
used
in Florida. Only pharma funded psychiatrists who supported the "new"
antipsychotics were invited. No one was invited from other camps who
dispute the "superiority " of the new antipsychotic drugs.

1. Send your letter to the editor:
2. Send it to Florida Governor Charlie Crist:


and cc Bob Butterworth
, Secretary of the
Florida Department of Children and Families.
3. If you're from Florida, send it to your own Florida State House
Rep
- find him/her he http://tinyurl.com/a48hb
http://tinyurl.com/a48hb find your zip code plus four there.
4 If you're from Florida, send it to your own Florida State Senator
-
find him/here he http://tinyurl.com/3twkxc
http://tinyurl.com/3twkxc

_____

St. Petersburg Times
Drug research: To test or to tout?
In the 1990s, drug companies trumpeted a new class of drugs, atypical
antipsychotics: better treatment, fewer shakes. They wanted the Food
and
Drug Administration to let them say their drugs were safer and more
effective than Haldol. But the FDA said no.
By Robert Farley
Saturday, April 12 (online)
http://www.tampabay.com/news/health/article454391.ece
http://www.tampabay.com/news/health/article454391.ece
Sunday, April 13 (paper) http://www.psychsearch.net/spt.pdf
www.psychsearch.net/spt.pdf (check out all the photos and graphics)

In the mental institution in One Flew Over the Cuckoo's Nest, Nurse
Ratched is obsessed with keeping order on the ward. She dispenses
pills
that sedate the residents into near zombies.

The novel was published in the 1960s, when Haldol and Thorazine were
the
drugs of choice to fight schizophrenia. They calm patients but also
can
cause uncontrollable shakes.

In the 1990s, drug companies trumpeted a new class of drugs, atypical
antipsychotics, that they billed as a dream solution: better
treatment,
fewer shakes.

Atypical antipsychotic drugs: left to right, ZyPREXA, SeroQUEL,
ABILIFY
and RISPERDAL.
http://www.tampabay.com/multimedia/archive/00018/
tb_atypicals_450_18990
a.jpg
[Martha Rial - Times]
Atypical antipsychotic drugs: left to right, Zy prexa, Seroquel,
Abilify
and Risperdal

They wanted the Food and Drug Administration to let them say their
drugs
were safer and more effective than Haldol. But the FDA said no,
because
the drug companies had submitted biased studies, according to
documents
obtained by the St. Petersburg Times.

It happened when Eli Lilly and Co. asked for approval of Zyprexa, and
again when Janssen asked for approval for Risperdal.

The FDA said Risperdal could come to market. But there was a caveat:
"We
would consider any advertisement or promotion labeling for Risperdal
false, misleading or lacking fair balance ... if there is a
presentation
of data that conveys the impression that (Risperdal) is superior to
haloperidol (generic for Haldol) or any other marketed antipsychotic
drug product with regard to safety or effectiveness."

Believing they had invented better drugs, not to mention the
opportunity
for outsized profits, the drug companies were undaunted by the FDA's
red
light.

Prohibited from touting their drugs as better? No problem. They paid
academics and doctors who said it for them.

The companies funded study after study that found - little surprise -
the new drugs were better and safer. State by state, the companies
funded committees that set treatment guidelines that decreed atypicals
should be the drugs of choice.

Despite the FDA ostensibly reining them in, the drug companies remade
the marketplace.

Atypicals have become the overwhelming drug of choice, and not just
for
schizophrenia and bipolar disorder, the crippling illnesses they were
approved for. Doctors commonly prescribe them to treat anxiety,
depression and ADHD in children. They're even given as sleep aids.

The new drugs can cost 20 times as much as the old, so taxpayers pay a
small fortune in Medicaid expenses. In Florida alone in the past five
years, taxpayers spent more than $1.1-billion on the new antipsychotic
drugs.

The drug companies, meantime, enjoy billions in profits.

. . .

Allen Jones knew the instant he was destined to be a whistle-blower.
He
says it was when his boss told him: "Quit being a salmon. Quit
swimming
against the stream with the pharmaceutical case."

It was a fluke that the case landed on his desk, and it was a fluke
that
he was even working in the office of the Inspector General in
Pennsylvania.

Twice divorced, a single dad with custody of his kids, he had been
swinging a hammer, doing rehab work on houses and flipping them. He
figured signing on with the state would give him financial security
and
early retirement.

But life has a way of veering from script, and in 2002, he happened to
draw a case where the state's chief pharmacist reportedly was earning
money on the side - from a pharmaceutical company.

Jones learned that the chief pharmacist headed a government panel that
would decide which drugs doctors should reach for first to treat
severe
mental illnesses in Pennsylvania. All of the drugs being touted as
front-line were brand new, patented, and therefore exceptionally
expensive. Yet some experts that Jones talked to said the new drugs
were
no better than the old ones.

"It didn't pass the smell test," he said. "There was too much
opportunity for fraud."

He suspected that pharmaceutical companies promoting their new drugs
were "buying off" state officials in positions to influence the
prescription practices of doctors across Pennsylvania. Taxpayers were
paying the freight for these high-priced drugs.

That's when Jones says his boss told him not to play the part of the
salmon. Drop it, the politicians will never stand for a real
investigation: "I was told point-blank, 'These pharmaceutical
companies
write checks on both sides of the aisle.' "

Jones ended up taking his concerns to the press. It wasn't long before
a
security guard escorted him from the building and into the ranks of
the
unemployed.

. . .

The idea of establishing state guidelines for prescription practices
originated in Texas in 1996, under an ungainly name:

The Texas Medications Algorithm Project. TMAP for short.

The goal was to bring together some of the best minds in the field to
reach consensus on how best to treat schizophrenia and bipolar
disorder.
TMAP would tell Texas doctors: Start with this drug, and if it doesn't
work, try this one. If a drug made the top of the list, the
manufacturer
stood to make millions.

The atypical drug companies stacked the deck: TMAP was seeded with a
$1.6-million grant from the charitable arm of the company that owns
Jannsen, which makes Risperdal. The panel was packed with doctors and
academics who were paid on the side from the companies that make
atypicals.

Proponents of guideline committees say they discourage unproven
practices, such as prescribing combinations of several antipsychotics.

Spearheading TMAP was Steven Shon, the Texas Health Department's
medical
director for behavioral health. A state employee, he was not allowed
to
accept money from the pharmaceutical companies.

He resigned amid an investigation that revealed he was taking money
from
Janssen. By then, with Shon's help, the Texas guidelines model had
been
exported to more than a dozen states, including Florida.

The Florida Behavioral Health Collaborative was the brainchild of Eli
Lilly and Co., which proposed it in 2004 and, with other drug
companies,
gave the state $10-million to create it.

According to Lilly spokeswoman Janice Chavers, the goal was not to
help
the company's profit margin, it was to give patients the best ca
"Patients always must be the top priority. It can't always be about
the
bottom line."

The Florida collaborative convened an expert panel to recommend state
standards for treating mental illness. National scholars were invited
-
all with financial ties to drug companies.

To treat schizophrenia, the panel decided, doctors should try an
atypical first. If that didn't work, they should try a different
atypical. If that still didn't work, they should try a third atypical
or, if they would rather, one of the older generation drugs.

. . .

Running Allen Jones out of his job only spurred him on. He tracked the
medications guidelines in Pennsylvania - Penn-MAP - back to its
birthplace in Texas.

In 2004, he filed a whistle-blower lawsuit in Texas against Johnson &
Johnson, parent company of Janssen. He said that to boost sales of
Risperdal, Janssen misled Texas health officials, overstating the
drug's
effectiveness and underplaying the risks.

"They got expert opinion to be the deciding factor," Jones said in an
interview. "Essentially, the drug companies could pay people to say
what
the drug companies could not claim themselves," namely that they were
superior to the older generation of antipsychotics.

"It was a concentrated, deliberate attempt to substitute illusion for
science."

A company spokesman denied it. "Janssen has always been committed to
the
highest ethical standards and responsible behavior . and this includes
clear, FDA-approved information about the product's efficacy and
safety
profile.''

Jones was not a lone wolf. The Texas attorney general joined his
lawsuit
in 2006 and demanded the return of tens of millions of taxpayer
dollars.

The still-pending lawsuit has reverberated around the country. Nine
states sued Eli Lilly, four sued Janssen, two sued AstraZeneca. Dozens
more states have teamed in a joint investigation, seeking billions of
dollars in restitution for money they say they overpaid for atypicals
through Medicaid.

Jones, the single dad just looking for a steady job, has morphed into
a
full-time megathorn in the side of pharmaceutical companies. He does
investigative work for law firms making cases against drug companies.
Senators and congressmen call him to talk about big pharma influence.

And Pennsylvania's chief pharmacist, the man Jones was fired for
speaking out about? He was indicted. The charges say that as head of
Pennsylvania's mental health guidelines committee, the pharmacist took
money and other perks from Pfizer and Jannsen, drug companies that
make
atypicals.

Looking back now, Jones is astonished by how few people it took -
academics, psychiatrists, state officials - for the drug companies to
influence state guidelines and bump up their sales by billions of
dollars.

"The marketing was complex, but not complicated," he said. "Divert
attention from the science. Divert attention to the scientists who are
in your pocket."

. . .

For years, the studies paid for by the drug companies concluded that
atypical antipsychotics are more effective and safer than the older
class.

But when governments conducted independent studies, the findings were
altogether different.

In 2005, the U.S. government funded a $60-million study called CATIE,
short for Clinical Antipsychotic Trials of Intervention Effectiveness.
It tracked a big sample (nearly 1,500 schizophrenics) for a long time
(18 months).

CATIE analyzed the performance of all the atypicals and one of the
typicals, perphenazine.

The two key conclusions: First, the atypicals generally were no more
effective than the older drug. Second, slightly fewer people on
atypicals dropped out of the study due to tremors, but the new drugs
had
their own troubling side effects, chiefly weight gain and diabetes.

What CATIE documented also was showing up in courthouses across the
country: Tens of thousands of people sued Eli Lilly and AstraZeneca,
saying that their drugs, Zyprexa and Seroquel, gave them diabetes and
elevated blood sugar levels. Eli Lilly reports having paid $1.2-
billion
to settle nearly 30,000 lawsuits.

In October 2006, a British government-funded study mirrored the CATIE
findings. Its results, the study said, "refute the hypothesis that the
use of (atypicals) is superior to the use of (typicals) in terms of
quality of life at one year."

How to jibe these independent, government findings against the earlier
studies that said atypicals were safer and more effective?

In a written commentary, the CATIE study's lead author said "the
claims
of superiority for the (atypicals) were greatly exaggerated.

"This may have been encouraged by an overly expectant community of
clinicians and patients eager to believe in the power of new
medications,'' wrote Dr. Jeffrey Lieberman. "At the same time, the
aggressive marketing of these drugs may have contributed to this
enhanced perception of their effectiveness in the absence of empirical
evidence."

The marketing has been a rousing success: Of the prescribed
antipsychotics in Florida last year, 86 percent were atypicals.
Nationally, atypical sales have risen every year, nearly double since
2000.

Dr. Robert Rosenheck, a Yale professor who participated in the CATIE
study, said the science doesn't justify that.

"There was never any evidence that warranted the amount of money we
spend on atypicals," he said. "If you look at it independently, it is
very clear the results say there is no benefit'' to atypicals over
typicals.

Yet the pharmaceutical companies get states to make them the drugs of
choice, he said.

"They leverage every single angle they can to persuade every person to
secure the opinion that their products are superior," Rosenheck said.
"Every possible source of opinion, they use money to establish a
relationship with them.

"The issue is not, 'Were these people influenced?' There is nobody who
is not influenced."

In Minnesota, one of the few states with a law that requires
disclosure
of pharmaceutical company payments to doctors, one report showed that
more than one-third of the state's psychiatrists took money from
drugmakers.

Last year, a nonprofit group funded by 13 states analyzed the academic
studies on atypicals. The Drug Effectiveness Review Project found that
an alarming number of study authors were employed by pharmaceutical
companies.

While academics and doctors often bristle at the suggestion their
opinions could be influenced by pharmaceutical money, another study
confirmed a not-unexpected conclusion: In trials of antipsychotic
medications, the outcome usually favored the drug of the company that
paid for the study.

Rosenheck believes that CATIE and other new studies are starting to
shift the tide in academia - slowly.

"Obviously, there's a certain amount of resistance to admitting, one,
I
was wrong, and two, I was misled by companies who paid me a lot of
money. That's a hard thing for a scientist to acknowledge."

He says states should change their medication guidelines so that the
older class of drugs are used, unless there is a clear reason to use
the
newer ones. For many patients newer may be better, he says, but to
continue the rampant use of atypicals despite the study findings is
bad
science.

"The idea that we could spend $60-million on a study and pay no
attention to it, it's like, let's not pay attention to science and
just
go with marketing."

. . .

The landscape had changed in the two years since the Florida
Behavioral
Health Collaborative set treatment guidelines favoring atypicals.

The CATIE study had been published. Tens of thousands of patients had
sued drug companies that made atypicals. The academic community was
more
divided about what was best.

Last July, the collaborative convened another group of experts to
revisit whether Florida should rely so heavily on atypicals. Two dozen
mental health professionals met at the Renaissance Hotel at Tampa's
International Plaza.

They gathered in the Kalamata Room, done up in the milquetoast style
of
a classic hotel meeting room: long tables arranged in a square, at
each
seat a glass of water and a name tag.

The bland setting belied the grand stakes: The vote could swing
hundreds
of millions of dollars in pharmaceutical company profits. Cost to
taxpayers, however, had no place in the conversation.

The meeting's two main hosts were Rajiv Tandon, chief of psychiatry
for
the state Department of Children and Families, and Robert Constantine,
head of the Florida Behavioral Health Collaborative.

Both believe in atypicals. In two papers they co-wrote in late 2006
and
early 2007, they said the CATIE study missed the point: The goal is to
create a good antipsychotic effect without the tremors, making
atypicals
the better choice.

Constantine, a research associate professor at USF's mental health
institute, is partly paid through a grant from Bristol-Myers Squibb,
which markets the atypical Abilify.

Tandon, a state employee, is not allowed to accept money from drug
companies. But three years ago, before coming to Florida from the
University of Michigan, he was a paid consultant and on the speaker's
bureau for several drug companies that make atypicals.

It was Tandon who invited the four national experts to be voting
members
on the Florida panel. All are consultants, serve on speakers bureaus
or
get research support from the drug companies that profit from
atypicals.

. William Glazer, who was brought in as the schizophrenia expert, is
president of Glazer Medical Solutions, a national consortium of mental
health care consultants. He is a consultant to Eli Lilly and
AstraZeneca.

His company Web site makes clear his bias: "Are you interested in
building a case for the value of new atypical antipsychotic
medications?
This section offers a step-wise approach to help providers, family
members, consumers and others advocate for access to these agents."

. Madhukar Trivedi, a professor of psychiatry at the University of
Texas
Southwestern Medical Center, is a consultant, serves on speakers
bureaus
or receives research money from 24 pharmaceutical companies, including
all the atypical makers.

. Terence Ketter, a professor of psychiatry and behavioral sciences
and
chief of the bipolar clinic at Stanford University, is a paid
consultant
or a lecturer for all the drug companies that make atypicals.

. John Greden, chairman of the psychiatry department at the University
of Michigan Medical Center, serves on scientific advisory boards for
five pharmaceutical companies, including two that make atypicals.

Tandon said he selected experts who are knowledgeable, respected
leaders
in their field, with a working knowledge of the medication guidelines
process. Because most experts have ties to the pharmaceutical
companies,
Tandon said, conflicts of interest are inevitable.

"There are clear conflicts of interest," he said. "Everyone is biased.
For someone to say, 'I'm not biased,' they are not truthful or they
are
not introspective."

Given that there is a divide in the academic world about atypicals,
why
not bring in someone from the other camp, maybe somebody from the
CATIE
study, someone who would challenge the existing medications model?

"You could go with extremes," Tandon said. "I didn't think that was
the
way to go," because the point of the process is to reach a consensus.

Atypicals are usually better, he said. "Were the benefits of atypical
medications exaggerated? Absolutely. And was it the pharmaceutical
companies doing that? Absolutely."

Still ... "By no means are the newer medications astoundingly better,
but they are better. If I have a child, I'm not going to start them on
a
typical."

More than a dozen Florida mental health officials sat on the
committee,
many of them adamant that the newer drugs generally offer a better
alternative to the older ones. They said they feared that if they put
the older drugs alongside the newer ones as front-line options, HMOs
might require them to go with the cheaper option.

To treat schizophrenia, the previous expert panel had made atypicals
the
first and second options. For the third option, doctors were left to
decide whether to try a third atypical.

This time around, the group kept atypicals the first option. As a
small
nod to CATIE, the group voted on a recommendation that if that first
atypical failed, a doctor should try either a second atypical or an
older-class, typical drug.

Asked for a show of hands, all were raised in favor.

http://www.tampabay.com/specials/200...-drugs-charts/
at
ypicals-tearsheets.gif

Times researcher Caryn Baird contributed to this report. Robert Farley
can be reached at or (727) 893-8603.

The atypicals

Older generation antipsychotics, called typicals, were prescribed for
schizophrenia and bipolar disorder but often caused Parkinson's-like
shakes. They were mostly replaced in the 1990s with the emergence of
atypical antipsychotics. The new drugs, which work on different brain
receptors, were touted as better and safer. Here are the atypicals now
on the market.

Trade name Drug name Marketed by

Clozaril Clozapine Novartis

Zyprexa Olanzapine Eli Lilly and Co.

Risperdal Risperidone Janssen Pharmaceutica

Seroquel Quetiapine AstraZeneca

Geodon Ziprasidone Pfizer

Abilify Aripiprazole Otsuka Pharmaceutical Co. and Bristol-Myers
Squibb

Invega Paliperidone Janssen Pharmaceutica

_____

26,512 Signatures Against TeenScreen.
http://www.petitiononline.com/TScreen/petition.html
http://www.petitiononline.com/TScreen/petition.html Video:
http://www.youtube.com/watch?v=RfU9puZQKBY
http://www.youtube.com/watch?v=RfU9puZQKBY

Thank you for sharing this. You beat me to it. I read this as we are in
Florida (our winter home).

Keep up the good work. I did sign the petition.

Jan