A Little Cynical bout Drug Companys Lately-Antidepressants/Zetia
Comments
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Three interesting views--Two from the NYT and third at the bottom a medical blogger.
All in the same week we have the Zetia flap and now this about anti-depressants. -----Who can you trust these days?
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The New York Times
January 17, 2008
Antidepressant Studies Unpublished
By BENEDICT CAREY
The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.
In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine.
Previous research had found a similar bias toward reporting positive results for a variety of medications; and many researchers have questioned the reported effectiveness of antidepressants. But the new analysis, reviewing data from 74 trials involving 12 drugs, is the most thorough to date. And it documents a large difference: while 94 percent of the positive studies found their way into print, just 14 percent of those with disappointing or uncertain results did.
The finding is likely to inflame a continuing debate about how drug trial data is reported. In 2004, after revelations that negative findings from antidepressant trials had not been published, a group of leading journals agreed to stop publishing clinical trials that were not registered in a public database. Trade groups representing the world’s largest drug makers announced that members’ companies would begin to release more data from trials more quickly, on their own database, clinicalstudyresults.org.
And last year, Congress passed legislation that expanded the type of trials and the depth of information that must be submitted to clinicaltrials.gov, a public database operated by the National Library of Medicine. The Food and Drug Administration’s Web site provides limited access to recent reviews of drug trials, but critics say it is very hard to navigate.
“This is a very important study for two reasons,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal. “One is that when you prescribe drugs, you want to make sure you’re working with best data possible; you wouldn’t buy a stock if you only knew a third of the truth about it.”
Second, Dr. Drazen continued, “we need to show respect for the people who enter a trial.”
“They take some risk to be in the trial, and then the drug company hides the data?” he asked. “That kind of thing gets us pretty passionate about this issue.”
Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said the new study neglected to mention that industry and government had already taken steps to make clinical trial information more transparent. “This is all based on data from before 2004, and since then we’ve put to rest the myth that companies have anything to hide,” he said.
In the study, a team of researchers identified all antidepressant trials submitted to the Food and Drug Administration to win approval from 1987 to 2004. The studies involved 12,564 adult patients testing drugs like Prozac from Eli Lilly, Zoloft from Pfizer and Effexor from Wyeth.
The researchers obtained unpublished data on the more recently approved drugs from the F.D.A.’s Web site. For older drugs, they tracked down hard copies of unpublished studies through colleagues, or using the Freedom of Information Act. They checked all of these studies against databases of published research, and also wrote to the companies that conducted the studies to ask if specific trials had been published.
They found that 37 of 38 trials that the F.D.A. viewed as having positive results were published in journals. The agency viewed as failed or unconvincing 36 other trials, of which 14 made it into journals.
But 11 of those 14 journal articles “conveyed a positive outcome” that was not justified by the underlying F.D.A. review, said the new study’s lead author, Dr. Erick H. Turner, a psychiatrist and former F.D.A. reviewer who now works at Oregon Health and Sciences University and the Portland Veterans Affairs Medical Center. His co-authors included researchers at Kent State University and the University of California, Riverside.
Dr. Turner said the selective reporting of favorable studies sets up patients for disappointment. “The bottom line for people considering an antidepressant, I think, is that they should be more circumspect about taking it,” he said, “and not be so shocked if it doesn’t work the first time and think something’s wrong with them.”
For doctors, he said, “They end up asking, ‘How come these drugs seem to work so well in all these studies, and I’m not getting that response?’ ”
Dr. Thomas P. Laughren, director of the division of psychiatry products at the F.D.A., said the agency had long been aware that favorable studies of drugs were more likely to be published.
“It’s a problem we’ve been struggling with for years,” he said in an interview. “I have no problem with full access to all trial data; the question for us is how do you fit it all on a package insert,” the information that accompanies many drugs.
Dr. Donald F. Klein, an emeritus professor of psychiatry at Columbia, said drug makers were not the only ones who can be reluctant to publish unconvincing results. Journals, and study authors, too, may drop studies that are underwhelming.
“If it’s your private data, and you don’t like how it came out, well, we shouldn’t be surprised that some doctors don’t submit those studies,” he said.
--------------------------------------------------------The New York Times
January 17, 2008
Cholesterol as a Danger Has Skeptics
By ALEX BERENSON
For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.
But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.
“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.
For patients and drug companies, the stakes are enormous. Led by best sellers like Lipitor from Pfizer, cholesterol-lowering medicines, taken by tens of millions of patients daily, are the largest drug category worldwide, with annual sales of $40 billion.
Despite widespread use of the drugs, though, heart disease remains the biggest killer in the United States and other industrialized nations, and many people still have cholesterol levels far higher than doctors recommend.
As a result, drug companies are investing billions of dollars in experimental new cholesterol-lowering medicines that may eventually be used alongside the existing drugs. If the new questions result in slower approvals, it would be yet another handicap for the drug industry.
Because the link between excessive LDL cholesterol and cardiovascular disease has been so widely accepted, the Food and Drug Administration generally has not required drug companies to prove that cholesterol medicines actually reduce heart attacks before approval.
They have not had to conduct so-called outcome or events trials beforehand, which are expensive studies that involve thousands of patients and track whether episodes like heart attacks are reduced.
So far, proof that a drug lowers LDL cholesterol has generally been enough to lead to approval. Only then does the drug’s maker begin an events trial. And until the results of that trial are available, a process that can take several years, doctors and patients must accept the medicine’s benefits largely on faith.
“You’ve got a huge chasm between F.D.A. licensure and a clinical events trial,” said Dr. Allen J. Taylor, the chief of cardiology at Walter Reed Army Medical Center.
Nonetheless, the multistep process has worked well for several cholesterol drugs — including Lipitor and Zocor, which are in a class of drugs known as statins. In those cases, the postapproval trials confirmed that the drugs reduce heart attacks and strokes, adding to confidence about the link between cholesterol and heart disease.
Doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters.
That continues to be the assumption of Dr. Scott M. Grundy, a professor of medicine at the University of Texas Southwestern Medical Center who was the chairman of a panel in 2001 that set national guidelines for cholesterol treatment.
“LDL lowering, however it occurs, delays development of coronary atherosclerosis and reduces risk for heart attack,” Dr. Grundy said this week. In atherosclerosis, plaque builds up in the arteries, eventually leading to blood clots and other problems that cause heart attacks and strokes.
In the last 13 months, however, the failures of two important clinical trials have thrown that hypothesis into question.
First, Pfizer stopped development of its experimental cholesterol drug torcetrapib in December 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes. That trial — somewhat unusual in that it was conducted before Pfizer sought F.D.A. approval — also showed that torcetrapib lowered LDL cholesterol while raising HDL, or good cholesterol.
Torcetrapib’s failure, Dr. Taylor said, shows that lowering cholesterol alone does not prove a drug will benefit patients.
Then, on Monday, Merck and Schering-Plough announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients. In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone.
Despite those drawbacks, that trial, called Enhance, also showed that patients on Vytorin had lower LDL levels than those on Zocor alone. For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits.
The Enhance trial was not an events trial and was not intended to study whether Zetia or Vytorin were effective at reducing heart attacks. But the growth of fatty plaque is closely correlated with heart attacks and strokes.
Without data from events trials for Zetia and Vytorin, no one can be certain if the drugs help or hurt patients. But Merck and Schering did not begin an events trial for the drugs until 2006, nearly four years after the F.D.A. approved Zetia. That trial will not be completed until 2011.
Dr. Robert M. Califf, the vice chancellor for clinical research at Duke University, and a co-lead investigator on the Zetia trial still under way, said companies should have started the trials more quickly. “Outcome trials ought to start when you know you’re going to get on the market,” he said.
On Tuesday, the American Heart Association called for the Zetia outcome trial to be completed as quickly as possible.
Merck has asked the F.D.A. to approve its drug Cordaptive, which raises HDL cholesterol and lowers LDL, without waiting for the results of an events trial. Merck has begun an events trial for Cordaptive, but data will not be available until 2013.
Merck has submitted the application for Cordaptive and has said it expects an answer from the F.D.A. before July. Doctors, patients and the drug industry will be waiting to see whether regulators are still willing to accept the theory that lower cholesterol is always a good thing.
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DB’s Medical Rants
Contemplating medicine and the health care system
Maybe lowering cholesterol does not matter
Cholesterol Drug Has No Benefit in Trial
While Zetia lowers cholesterol by 15 to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems.
This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew somewhat faster in patients taking Zetia along with Zocor than in those taking Zocor alone. Patients in the trial who took the combination of Zetia and Zocor were receiving it in the form of Vytorin pills.
Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.” Patients should not be prescribed Zetia unless all other cholesterol drugs have failed, he said.
“This is as bad a result for the drug as anybody could have feared,” Dr. Nissen said. Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects, he said.
When statins first hit the market, we believed that they worked primarily through cholesterol lowering. Some experts now believe that their main benefit comes from plaque stabilization and reducing coronary artery inflammation.
The data suggest that statins work regardless of the starting cholesterol level. Perhaps LDL cholesterol simply stratifies the risk of MI. The Zetia study suggests that lowering cholesterol is not as important as how one lowers the cholesterol.
These data add to our knowledge of the “cholesterol hypothesis.” This study calls into question having target goals for LDL cholesterol. Perhaps we should have treatment goals rather the outcome goals. I would suggest that being on a high dose statin works - we probably do not need to worry about the final LDL number.
These results will shake some readers faith in science. For me the results add to our understanding. This study affirms the value of scientific inquiry.
James Joyce said, “A man’s errors are his portals of discovery.”
Maybe lowering cholesterol does not matter was written by rcentor and filed in Medical Rants.
Published on January 14. 2008 · Last updated on January 14. 2008
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Susie, this is just outrageous! How can these drug companies morally do this. It's about the all mighty dollar. Sad, sad, sad! I think they should face some kind of penalty.
I haven't read the entire article about the anti-deps, but will tomorrow. I'm too tired tonight. I'm am just so darned angry.
Shirley
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Here's a reference that seems relative to this conversation...sorry it's so long.
Commentary
Holiday Every Day for Pharma under the Bush Administration
Evelyn Pringle
Investigative Journalist
Email: epringle05@yahoo.com
Abstract
A December 21, 2004 report by the watchdog group Public Citizen provides information that explains why it’s been a holiday
every day for the pharmaceutical industry, since George W. Bush took office.
Thirteen pharmaceutical industry executives or lobbyists rank among Bush’s “Rangers” and “Pioneers,” the honorary titles given to
those who have raised at least $200,000 or $100,000, respectively, for one of Bush’s presidential campaigns, according to Public Citi-
zen, “Together, these pharmaceutical industry super-fundraisers have raised at least $2.2 million for Bush.”
This report also provides details concerning TeenScreen, the Texas Medication Algorithm Project (TMAP), and other programs,
including Medicaid, the National Institute of Health (NIH), and Food and Drug Administration (FDA) riddled with conflicts of inter-
est.
© Copyright 2005. Pearblossom Private School, Inc.–Publishing Division. All rights reserved.
Keywords: Pharmaceutical industry profits, TeenScreen, government conflicts of interest
Bush Administration and Pharma Industry: A revolving
door
A December 21, 2004 report by the watchdog group Public
Citizen provides information that explains why it’s been a holi-
day every day for the pharmaceutical industry, since George W.
Bush took office.
For its December 2004 report, Public Citizen conducted an
analysis of lobbying disclosure forms filed with the Secretary of
the Senate and Clerk of the House, and the report provides rele-
vant information about the pharma-connected fundraisers.
Pharmaceutical Research & Manufacturers of America
(PhRMA) itself, the industry’s trade group, spent more than $16
million for lobbying lawmakers in 2003, a 12.5% increase from
2002. In 2003 it hired 136 lobbyists, 24 more than in 2002, ac-
cording to a June 2004 report by Public Citizen.
Since Bush took office, he’s done much to enact policies to
enrich his top contributors. By the end of the 2004 reelection
campaign, Bush campaign headquarters must have resembled a
PhRMA annual reunion.
Thirteen pharmaceutical industry executives or lobbyists
rank among Bush’s “Rangers” and “Pioneers,” the honorary
titles given to those who have raised at least $200,000 or
$100,000, respectively, for one of Bush’s presidential cam-
paigns, according to Public Citizen, “Together, these pharma-
ceutical industry super-fundraisers have raised at least $2.2 mil-
lion for Bush.”
Campaign rainmakers, include top executives such as Pfizer
CEO, Ranger Hank McKinnell. Until last year, McKinnell
served as chairman of the board for PhRMA. His company pro-
duces 14 drugs that are the top sellers in their respective catego-
ries. Public Citizen reports that Pfizer ranks second among all
drug companies in terms of lobbying expenditures – spending
$5.3 million in 2003.
Retired Bristol-Myers Squibb Vice Chairman, Pioneer Bruce
Gelb, is now a senior consultant to the company. Gelb has long-
standing ties to the Bush family. He was appointed chief of the
US Information Agency, and ambassador to Belgium by the
first president Bush.
Before the 2000 election, Bristol-Myers executives report-
edly were pressured to make maximum donations to the Bush
campaign. Reluctant donors were warned that CEO Charles
Heimbold, Jr. – whom Bush later named ambassador to Sweden
– would be informed if they failed to give, according to the
September 5, 2003 New York Times article, Industry Fights to
Put Imprint on Drug Bill.
Lobbyist Tom Loeffler is a former Congressman himself. In
2000, he served as finance co-chair for the Bush-Cheney cam-
paign, and for Bush’s first gubernatorial race in Texas, accord-
ing to the January 13, 2003 New York Sun. He is currently a
self-employed lobbyist with his own firm, Loeffler Jonas &
Tuggey, whose client list includes Bristol-Myers and Purdue
Pharma. Loeffler was a Pioneer in 2000 and a Super-Ranger in
2004 raising more than $300,000. Loeffler took in $580,000 in
2003 from Bristol-Myers, Purdue Pharma, and PacifiCare.
In May 2000, Loeffler set up his own firm and business has
increased fivefold since Bush took office. His website boasts of
“strong ties to the current administration, having worked di-
rectly with the President, Vice President, the White House
Chief of Staff, Cabinet secretaries and their aides,” according to
Public Citizen.
Bill Paxon is a lobbyist for Akin Gump and was a Bush Pio-
neer in 2000 and 2004. In 2003, Akin Gump had total revenues
from the pharmaceutical industry of $2,020,000, including
$600,000 from PhRMA, $420,000 each from Pfizer and Abbot,
$240,000 from Johnson & Johnson, $120,000 from Wyeth,
$80,000 from Merck, and $140,000 from Human Genome Sci-
ence, reported Public Citizen.
A review of lobbyist registration forms on the issue of drug
importation alone revealed that seven former members of the
Bush administration are listed, six of whom lobbied their for-
mer agency. But these seven are not the only people who have
passed through the revolving door between the Bush admini-
stration and the pharmaceutical industry. At least 14 senior offi-
cials have left to work or lobby for drug companies or PhRMA.
Federal law prohibits officials from lobbying their former
employing agency for a period of one year, but the ban only
applies to the specific sub-office where an official used to work.
This enables officials to openly exploit the connections they
gained in the course of their public employment, which is evi-
denced by the large number of officials who are registered to
lobby their former agency. This practice allows special interests
to corrupt the federal decision-making process by promising
officials high-paying jobs offered only because of their position
of power in the government decision-making process.
One of the most blatant examples of the revolving door prac-
tice is Tom Scully, who was the chief administrator for the Cen-
ters for Medicare and Medicaid Services and Bush’s lead nego-
tiator with Congress on the prescription drug bill, while he was
discussing employment opportunities with a half dozen health-
care-sector employers.
In December 2003, less than one month after the bill was
signed, Scully accepted jobs from both the lobbying firm of
Alston & Bird and the private equity investment firm Welsh,
Carson, Anderson & Stowe. Since Scully came on board,
Alston & Bird has signed up at least a dozen drug company
clients, including Abbott and Aventis Pharmaceuticals.
Just three days after the Medicare bill was signed, another
one of the lead senate negotiators, Colin Roskey, left his job as
health policy adviser and counsel for the Senate Finance Com-
mittee for a position with Alston & Bird, one of the same firms
that hired Scully.
Robert Wood, who was the chief of staff for HHS Secretary,
Tommy Thompson, accepted employment with Barbour, Grif-
fith & Rogers in June 2003. From there, he has lobbied on be-
half of Bristol-Myers, GlaxoSmithKline, Pfizer, and PhRMA.
In 2004, Wood even lobbied the HHS and the White House for
Pfizer and GlaxoSmithKline.
Public Citizen also lists two former pharma executives who
have been placed in influential positions within the administra-
tion, where they can push their former, and potentially future,
employers’ interests:
Doug Badger became Bush’s top health policy adviser in
October 2002, after helping to bring in more than $1 million for
Washington Council Ernst & Young in 2002 from clients like
Aventis Pharmaceuticals, Eli Lilly, Johnson & Johnson and
Pfizer.
Ann-Marie Lynch, was positioned as the principal assistant
deputy secretary for planning and evaluation at HHS, after
Lynch had lobbied HHS and the FDA, on behalf of PhRMA in
2001, according to Public Citizen’s analysis of lobbying disclo-
sure forms.
Many top staffers have also left the administration to lobby
for pharma. Dirksen Lehman was a special assistant to the
president for legislative affairs, and served as the chief White
House liaison to the Senate for Medicare, Medicaid and health
care regulations. In May 2003, Lehman became a lobbyist for
Clark & Weinstock, and during the Medicare debate, he lobbied
on behalf of clients such as Aventis, Novartis and PhRMA.
Overall, lobbying hit an all-time high in 2003. Nearly $2
billion was spent on efforts to pass the industry-friendly version
of the prescription drug bill alone. A little over $1 billion was
spent during the 6 months immediately prior to the vote on the
bill. This was the first time Washington lobbying reached a
billion dollar mark in a 6 month period, according to a study by
the nonpartisan Political Money Line campaign tracking ser-
vice.
In the end, the Medicare bill that passed does very little for
seniors, but represents a windfall for pharma. The average sen-
ior will have about $3,160 in total drug costs in 2006, when the
program kicks in, according to a November 20, 2003 letter from
the Congressional Budget Office to Senator Don Nichols (R-
OK).
Under the new law, the average senior will have to pay 66%
of that $3,160, or $2,080. Most will have to pay a $420 annual
premium, a yearly deductible of $250, and co-payments on
drugs. Co-payments are 25% on the first $2,250, and then rise
to 100% of the cost between $2,251 to $5,100, referred to as the
“doughnut hole,” according to a March 2004 Kaiser Family
Foundation Medicare Fact Sheet.
Never-Ending Money Trail
When Bush signed the Medicare prescription drug bill in
2003, he praised three supposedly non-profit organizations
which are actually front groups financed by pharma. Bush said
in part:
“Jim Martin, the president of 60 Plus Association, worked
hard. Charlie Jarvis, the chairman and CEO of United Seniors
Association, worked hard,” he said. “Mary Martin, the chair-
man of the board of the Seniors Coalition, worked hard.”
These three groups, plus the new group, America 21, which
arrived on the scene in 2002, all claim to be advocacy groups
for seniors or evangelical Christians.
In 2002, the groups sponsored broadcasts and direct mailings
that mirrored one another’s – and focused heavily on the pre-
scription drug bill, which was the top legislative concern for
PhRMA, according to a September 2004 report, Big PhRMA’s
Stealth PACs, by Public Citizen.
In 2002, PhRMA appears to have channeled as much as $41
million to its four Stealth PACs, according to records filed with
the IRS. Money from the drug industry’s association enabled
USA, 60 Plus, the Seniors Coalition, and America 21 to broad-
cast ads and send direct mailings in 39 US Senate and House
contests that year. The ads consistently supported candidates
friendly to PhRMA’s agenda and criticized those considered
unfriendly, the Citizen’s report said.
In 2002, USA reported nearly $18.6 million in radio and
television ads on its 990 tax form. The Wisconsin Advertising
Project, the academic research program assessing the political
content of ads, concluded that 72.9% of the group’s television
activity was intended to influence the outcome of elections, as
opposed to issue-advocacy work. Based on these two figures,
Public Citizen estimates that USA spent $13.6 million on ads
intended to influence elections in 2002.
Voters had no way of knowing that the ads and mailings
were underwritten with industry money. PhRMA was able to
stay hidden in the background while exerting substantial influ-
ence through the 501(c) groups that acted as PhRMA’s Stealth
PACs.
Time for Bush to Pay Up
The government-backed mental health screening programs
sprouting up all over the country represent another gift from
Bush to the pharmaceutical industry.
On April 29, 2002, Bush established The New Freedom
Commission (NFC) by executive order. On that day, while
speaking in New Mexico, Bush said mental health centers and
hospitals, homeless shelters, the justice and school systems
have contact with individuals suffering from mental disorders,
but that too many Americans fall through the cracks of the cur-
rent system, and so he created the Commission to ensure “that
the cracks are closed.”
On July 22, 2003, a NFC Report recommended redesigning
the mental health systems in all 50 states, and its press release
stated, “Achieving this goal will require greater engagement
and education of first line health care providers—primary care
practitioners—and a greater focus on mental health care in insti-
tutions such as schools, child welfare programs, and the crimi-
nal and juvenile justice systems. The goal is integrated care that
can screen, identify, and respond to problems early.”
On February 5, 2003, a subcommittee report titled, Promot-
ing, Preserving and Restoring Children’s Mental Health, stated
in part, “The extent, severity, and far-reaching consequences of
mental health problems in children and adolescents make it
imperative that our nation adopt a comprehensive, systematic,
public health approach to improving the mental health status of
children.”
The NFC’s final report calls for mental health screening for
every child in America, including preschool children, and states
that “schools are in a key position to identify mental health
problems early and to provide a link to appropriate services.”
Children who are hooked into government programs, often
through no fault of their own, will automatically be screened
due to the NFC recommendation that, “Screening should be
implemented upon entry into, and periodically thereafter in, the
juvenile justice and child welfare systems, as well as in other
settings and populations with known high risk, such as the
Medicaid population. When mental health problems are
identified, youth should be linked with appropriate services and
supports.”
To that end, the NFC recommends that a program known as
TeenScreen be set up in all 50 states. The program is billed as a
suicide prevention tool when in actuality, it is just another com-
ponent in a government-backed marketing scheme to recruit
kids as prescription drug customers for pharma.
First of all, pharma does not need more customers. Dr.
Marcia Angell, former editor of the New England Journal of
Medicine, lists the industry’s annual drug sales at $200 billion
in the US and $400 billion worldwide in her book, The Truth
About the Drug Companies: How they Deceive us and What To
Do About It, Random House (2004).
And we don’t need more people hooked on psychiatric
drugs. According to Dr. Barry Duncan, PSYD, author of What’s
Right With You (2005), “in 2003 more than 150 million pre-
scriptions were written for antidepressants, and more than $14
billion was spent on them.” Yet as Dr. Duncan points out, “rates
of depression have not changed for thirty years,” and “suicide
rates, despite the millions taking antidepressants, have not re-
duced.”
Critics from all walks of life are outraged about the plan to
screen the nation’s school population for various reasons. “The
New Freedom Commission is blatantly promoting the coercive
and manipulative tactics that have led to millions of children
being falsely labeled with mental disorders in our public
schools,” according to Peter Dockx, of the Citizen’s Commis-
sion on Human Rights.
“The goal is to promote the patently false idea that we have
a nation of children with undiagnosed mental disorders crying
out for treatment,” says Congressman Ron Paul (R-TX), who is
also a physician, in Forcing Kids Into a Mental Health Ghetto.
“How in the world have we allowed government to become
so powerful and arrogant that it assumes it can force children to
accept psychiatric treatment whether parents object or not?”
asks Congressman Paul, “What kind of free people would turn
their children’s most intimate health matters over to govern-
ment strangers?”
In an October 31, 2004 letter to the editor of the Washington
Times, pediatrician Dr. Karen Effrem points out: “Whatever
good may come from the other recommendations (of the NFC),
is completely overshadowed by the loss of freedom and damage
that would come from labeling and drugging potentially mil-
lions of children based on these unsupportable screening and
treatment programs.”
Dr. Jane Orient, Executive Director of the Association of
American Physicians and Surgeons (AAPS), is perturbed about
the government’s invasion of privacy involved in this money-
making scheme. “Teams of experts are awaiting an infusion of
cash,” she says, “They’ll be ensconced in your child’s school
before you even know it.”
To parents of children undergoing screening, Dr. Orient
notes that an added “bonus is that your little darlings will
probably give them quite a bit of information about you also,
and then you can receive therapy you didn’t know you needed.”
According to Orient, kids will be asked nosey questions like
whether their parents raise their voice, or “Ever spank them?
Have politically incorrect attitudes? Use forbidden words? Own
a gun? Smoke cigarettes, especially indoors? Read extremist
literature? Refuse to recycle?”
“Prepare for a knock at the door,” she warns, “The answers
to these questions could lead to a home visit.”
School screening programs are clearly a part of an overall
marketing scheme aimed at mining as many children as hu-
manly possible and converting them into life-long prescription
drug customers before they even graduate from high school.
“One obvious beneficiary of the proposal is the pharmaceutical
industry,” warns Congressman Paul, “which is eager to sell the
psychotropic drugs that undoubtedly will be prescribed to mil-
lions of American school children under the new screening pro-
gram.”
The NFC also recommends screening for all pregnant
women which will no doubt lead to the use of selective-
serotonin re-uptake inhibitors (SSRIs) antidepressants, even
after the results of a study published in the American Journal of
Pediatrics, and reported in the February 2, 2004 News Tele-
graph, showed that pregnant women who use SSRIs “to combat
depression could be damaging the brains of their unborn ba-
bies.”
According to the study, the direct evidence of a link between
fetal exposure and disrupted neurological development became
apparent in a study of American mothers and their babies. “Ab-
normal sleeping patterns, heart rhythms and levels of alertness
were linked by researchers to drugs called selective-serotonin
re-uptake inhibitors (SSRIs),” it noted.
Philip Zeskind, a developmental psychologist and research
professor of pediatrics at the University of North Carolina, who
led the investigation, told the Telegraph, “What we’ve found is
that SSRIs disrupt the neurological systems of children, and that
this is more than just a possibility, and we’re talking about hun-
dreds of thousands of babies being exposed to these drugs dur-
ing pregnancy.”
“These babies are bathed in serotonin during a key period of
their development and we really don’t know what it’s doing to
them or what the long-term effects might be,” he warned.
"We’re not saying that pregnant women should not take the
drugs, because depression is itself a big problem," the Professor
said, “But these drugs are being given away like smarties, and
this is a big problem.”
TeenScreen is a Fraud
TeenScreen claims that it can assess a variety of mental
disorders in 10 minutes. On March 2, 2004, the program’s Ex-
ecutive Director, Laurie Flynn, testified at a congressional hear-
ing and said that in the screening process, “youth complete a
10-minute self-administered questionnaire that screens for so-
cial phobia, panic disorder, generalized anxiety disorder, major
depression, alcohol and drug abuse, and suicidality.”
The survey is already being administered to students all over
the country even after an investigation by the US Preventive
Services Task Force found no evidence that any screening
reduces suicide attempts or mortality, and warned that there is
only limited evidence on the accuracy of screening tools used to
identify suicide risk.
While appearing before Congress, Executive Director,
Flynn, had the nerve to ask lawmakers to redirect funding allo-
cated for alcohol and drug abuse treatment programs to set up
TeenScreen programs in public schools.
In other words, she is asking Congress to take tax dollars
earmarked for alcohol and drug treatment and allow the money
to be used to implement a nationwide marketing scheme for the
most profitable industry on the planet, which will without a
doubt, propel millions of normal children straight into drug
addiction.
TeenScreen was developed in large part, by psychiatrist
David Shaffer, of Columbia University. Shaffer has many
known financial ties to pharma. He has served as an expert wit-
ness on behalf of drug companies in several trials, and has
worked as a consultant for pharma on various psychotropic
drugs.
In 2003, when British regulators were set to recommend
against the use of SSRI antidepressants in the treatment of chil-
dren because the drugs had been linked to suicidal thoughts and
self-harm, Shaffer, at the request of a drug maker, attempted to
block the recommendation by sending a letter to the British
regulatory agency claiming there was insufficient data to re-
strict the use of the drugs in adolescents, according to the De-
cember 11, 2003 New York Times.
The truth is, the TeenScreen survey cannot possibly diag-
nose mental illness in kids, for reasons cited by the US Surgeon
General in 1999, “The normally developing child hardly stays
the same long enough to make stable measurements ... the signs
and symptoms of mental disorders are often also the
characteristics of normal development.”
Dr. Effrem explains that psychiatric diagnoses are inherently
subjective and warns that “America’s children should not be
medicated by expensive, ineffective, and dangerous medica-
tions based on vague and dubious diagnoses.”
“There’s no doubt that there are kids who are bored, who are
frustrated, who are anxious, there’s no doubt that some kids
don’t fit into our schools and some aren’t doing well in their
families,” Dr Peter Breggin advises. “But there’s no evidence
whatsoever that it’s a disease or a medical disorder, it’s a child
in conflict, it has to be dealt with in a conflict situation,” he
said.
The screening programs implemented in many schools have
already caused grave injuries to children. For example, while in
the 7th grade, Aliah Gleason became a victim of mental health
screening at school, which led to five months in the hospital,
during which time her parents were not allowed to see or speak
to her.
During her hospitalization, Aliah was placed in restraints
more than 26 times and given at least 12 different psychiatric
drugs, many simultaneously, including antidepressants Zoloft,
Celexa, Lexapro and Desyrel; Ativan, an antianxiety drug; and
two of the newer, very expensive atypical antipsychotics -
Geodon and Abilify. (See Waters R, Medicating Aliah; Mother
Jones, May 2005.)
After the hospital stay, Aliah spent four more months in a
residential facility—getting even more drugs, according to
Dangers of Mental Health Screening, by Nathaniel Lehrman,
MD, September 23, 2005.
Another victim of a school screening is 15-year-old Chelsea
Rhoades of Indiana. In December 2004, in accordance with her
school’s TeenScreen program, Chelsea was given a ten minute
yes-or-no test without her parent’s knowledge or consent.
Shortly after the test, an employee from the Madison Mental
Health Treatment Center informed Chelsea that she was diag-
nosed with an obsessive compulsive disorder and a social anxi-
ety disorder and advised Chelsea that her mother should bring
her to the Madison Center for treatment if her condition wors-
ened.
Chelsea’s parents were livid, not only about the testing
without their consent, but over the school labeling their daugh-
ter mentally ill. The family has since filed a law suit, with the
assistance of the Rutherford Institute against the school district
and the Madison treatment center.
The TMAP Component
The New Freedom Commission specifically recommends
the, “Texas Medication Algorithm Project (TMAP),” as a
model medication treatment plan which it claims “illustrates an
evidence based practice that results in better consumer out-
comes.”
An algorithm is a flow chart of guidelines that doctors use to
identify and medicate a certain illness. It’s a formulary of spe-
cific drugs that a doctor must prescribe. If a drug is not on the
list, it cannot be used as a first or second line of treatment for an
illness.
The true motive behind the development of the original
TMAP, was to recruit new customers from the Texas juvenile
justice system, foster care program, mental health hospitals, and
prison systems to generate high volume sales of pharma’s new-
est and most expensive drugs. Once in place, the TMAP gave
pharma unlimited access to Texas institutions to expand its cus-
tomer base.
TMAP provided a direct funnel for tax dollars to pharma, a
process that was further enhanced when Texas lawmakers
passed legislation to increase Medicaid coverage for prescrip-
tion drugs to persons who did not ordinarily qualify, and in-
creased the state budget to pay for the cost of psychiatric drugs
for people in public institutions. In addition, as governor, Bush
supported legislation that required private industry to provide
increased insurance coverage for psychiatric drugs.
The guidelines for the TMAP were established in the 1990s,
while Bush was governor of Texas, by an “expert consensus,”
based not on scientific research, but on the opinions of hand-
picked members of an “expert” panel. Panel members were
drawn from pools of candidates who were already known to be
supportive of the drugs pharma wanted on the lists. In most
instances, the “experts” chosen had easily traceable financial
ties to pharma.
For example, one “expert” with a host of financial ties to
drug companies is Dr. Karen Wagner. According to the Journal
of the American Medical Association, Wagner conducted a
Pfizer-funded study and reported that Pfizer’s SSRI Zoloft was
safe, effective and well-tolerated in children, at an extremely
convenient time when both the British Committee on Safety in
Medicines and the FDA had announced that they were re-
examining the data from clinical trials and studies on all SSRIs.
Over the years, Wagner has received research funding from
Abbott, Bristol-Myers, Eli Lilly, Forest Laboratories, GlaxoS-
mithKline, Organon, Pfizer, and Wyeth-Ayerst. She has served
as a National Institute of Mental Health consultant to Abbott,
Bristol-Myers, Cyberonics, Eli Lilly, Forest Laboratories,
Glaxo, Novartis, Otsuka, Janssen, Pfizer, and UCB Pharma, and
she has participated in speaker’s bureaus for Abbott, Eli Lilly,
Glaxo, Forest, Pfizer, and Novartis, as reported by Drug News
on September 3, 2003.
The website http://www.cspinet.org/integrity/index.html lists
connections between drug companies and researchers, and lists
expert panel member, Graham Emslie, MD as: Consultant to
GlaxoSmithKline, Forest, and Pfizer. Receives research support
from Eli Lilly, Organon, Religion, and Wyeth-Ayerst. Member
of the speaker’s bureau for McNeil.
Many other “experts” on the panel had financial ties to
Pharma. Dr Jack Gorman of the New York Psychiatric Institute
had received over $140,000 between April 1, 1997 and March
31, 1998, in speaking fees, travel accommodations, board
memberships, and consulting fees from Janssen, Eli Lilly,
Pfizer, and other drug companies.
In fact, twelve panel members were from the New York
Psychiatric Institute, and each was found to have profited from
drug company money.
Nearly all of the major drug companies were involved in
funding the TMAP component of scheme, including Eli Lilly,
Janssen Pharmaceutica, Johnson & Johnson, AstraZeneca, No-
vartis, Janssen-Ortho-McNeil, GlaxoSmithKline, Abbott,
Pfizer, Bristol Myers Squibb, Wyeth-Ayerst and Forrest Labo-
ratories.
The TMAP mandates the use of the most expensive drugs on
the market for the first and second line of treatment for schizo-
phrenia, bipolar disorder and depression. The drugs chosen by
the “experts” were predictably manufactured by the same com-
panies that funded the scheme and include, Zyprexa, Paxil,
Zoloft, Allerall, Risperdal, Seroqual, Depakote, Prozac, Celexa,
Wellbutrin, Zyban, Remeron, Serzone, Effexor, and Buspar.
A couple of years after the original TMAP was in place in
Texas, another “expert” panel was chosen to formulate the
TCMAP, a list of drugs to be used on children. The panel basi-
cally decided that the drugs on the adult list should be used on
children for the first and second line of treatment for bipolar
disorder, depression and schizophrenia.
The expert consensus process has become the standard de-
vice used for approving drugs for the formularies and it has
been employed repeatedly between 1996 and 2003.
Drugs are Dangerous and Ineffective
For years, the studies that have shown atypicals and SSRIs
to be ineffective and dangerous have been intentionally ex-
cluded from the promotional materials released by drug makers,
and the literature sent to doctors portrayed a totally false ap-
praisal of the drugs.
The worst part of this tragedy is that in the end, the new
generation of "miracle drugs," have not only proven to be ex-
tremely harmful, they are no more effective then the older,
cheaper drugs, and the drug companies and the regulatory offi-
cials knew it.
As far back as December 2000, a review of 52 studies in-
volving 12,649 patients published in the British Journal of Psy-
chiatry reported: "There is no clear evidence that the atypical
antipsychotics are more effective or better tolerated than con-
ventional antipsychotics."
In November 2003, the Journal of the American Medical
Association reported the results of a study that tracked 309
schizophrenic patients at seventeen VA hospitals for 12 months.
Of those 309 patients, 159 received Lilly’s Zyprexa, and 150
took the generic antipsychotic, Haldol. The study monitored
symptom reduction and adverse effects, along with quality of
life, patient satisfaction, and costs.
In the end, the study found no significant advantage to pa-
tients on Zyprexa in measures of compliance, symptoms, or
overall quality of life. It determined that neither Zyprexa nor
Haldol was superior to the other and the only major difference
was the cost. Zyprexa prices were between $3,000 to $9,000
more per patient each year than Haldol.
According to Dr. Stefan Kruszewski, the entire new genera-
tion of antipsychotics are extremely harmful and substantially
increase the risk of obesity, diabetes type II, hypertension, car-
diovascular complications, heart attacks and stroke. “The drug
makers had this information and simply ignored the problem,”
he said.
In September 2003, the FDA directed the makers of all
atypicals to add a warning to their labels that the drugs can
cause hyperglycemia, diabetes, and even death. Janssen was
also instructed to send a letter to health care providers acknowl-
edging that the company had misled providers by representing
that Risperdal did not increase the risk of diabetes.
In fact, Janssen had to admit that the drug probably does
increase the risk. On July 24, 2004, the Miami Herald reported
that the “maker of a billion-dollar antipsychotic medication has
acknowledged misleading doctors and other healthcare provid-
ers about the safety of its product, minimizing potentially
deadly side effects.”
“Risperdal is the leading drug used to combat schizophrenia
... earning Janssen about $2.1 billion in annual sales,” the Her-
ald noted. “The drug was first marketed about eight years ago,
and is prescribed to more than 10 million people worldwide.”
Another side effect of atypicals was discovered in a govern-
ment study released in June 2005, which revealed that patients
taking the drug Risperdal had a higher incidence of benign tu-
mors in the pituitary gland. The FDA study was presented on
June 18, 2005 at a University of Pittsburgh conference. The
following information describes the methodology and findings
of this FDA study:
The researchers analyzed 2.5 million adverse events reported
by doctors, patients, and individuals since 1968. Of the 307
reports of pituitary tumors, 64, or 21%, occurred in patients
taking antipsychotics. Forty-eight reports of pituitary tumors
were reported in patients taking Risperdal according to the June
17, 2005 Wall Street Journal. A lead author of the study, Ana
Szarfman, noted that this kind of study cannot accurately de-
termine how common “the pituitary tumor side effect may be
for users of Risperdal and the other atypical antipsychotics be-
cause, unfortunately, it is well-known that doctors do not report
all suspected adverse drug reactions to the FDA’s MedWatch
program,” the WSJ wrote.
As of April 2005, the FDA now requires Black Box warn-
ings about the increased risk of death on the labels of atypical
drugs such as Zyprexa (Eli Lilly), Risperdal (Janssen), Abilify
(Bristol-Myers Squibb), Clozril (Novartis), and Geodon
(Pfizer).
As for the effectiveness of SSRIs, in June 2005, the Wash-
ington Post reported that “Despite a dramatic increase in treat-
ment of psychiatric disorders during the past 10 years, there has
been no decrease in the rate of suicidal thoughts and behavior
among adults, according to a federal study primarily funded by
the National Institute of Mental Health.”
“The study found that although people who attempt suicide
were far more likely to be treated, especially with antidepres-
sants in 2001-03 compared to 1990-92, the rates of suicidal
ideation, gestures and attempts remained basically unchanged,
according to researchers from Harvard Medical School and
elsewhere, in their published findings in the Journal of the
American Medical Association,” the Post wrote.
During the February 2004 FDA hearings on SSRIs, re-
searchers presented evidence that showed that with children,
SSRI’s were little or no more effective than placebos. Psy-
chologist David Antonuccio, from the University of Nevada
Medical School, was part of a team that analyzed 12 studies and
told the committee, “Our conclusions were that the advantages
of the antidepressants in children were so small and so trivial as
to be clinically insignificant.”
“In order to evaluate the cost effectiveness of antidepressant
use in children, the committee must consider the benefits, as
well as the risks,” Dr. Antonuccio testified. “Clinically mean-
ingful benefits have not been adequately demonstrated in de-
pressed children, therefore, no extra risk is warranted.”
“An increased risk of suicidal behavior is certainly not justi-
fied by these minimal benefits,” he said. “Neither are the estab-
lished increased risks of other commonly reported side effects,
which include agitation, insomnia, and gastrointestinal prob-
lems,” he added.
The FDA committee heard from 65 speakers during the
hearing, many of whom were grieving parents of children who
had committed or attempted suicide or homicide after being
placed on SSRIs which led to dramatic behavioral changes.
Probably the most damning comments regarding SSRIs
come from one of their inventors, Dr Candace Pert. She worked
at the NIH for 13 years and was one of the two scientists who
discovered the serotonin binding process that made SSRIS pos-
sible, according to DrugAwareness.org.
“I am alarmed at the monster that Johns Hopkins neuroscien-
tist Solomon Snyder and I created when we discovered the sim-
ple binding assay for drug receptors 25 years ago,” Dr. Pert
said, “Prozac and other antidepressant serotonin-receptor-active
compounds may also cause cardiovascular problems in some
susceptible people after long-term use, which has become
common practice despite the lack of safety studies.”
"The public is being misinformed about the precision of
these selective serotonin-uptake inhibitors when the medical
profession oversimplifies their action in the brain and ignores
the body as if it exists merely to carry the head around!" she
advised. “In short, these molecules of emotion regulate every
aspect of our physiology. A new paradigm has evolved, with
implications that life-style changes such as diet and exercise
can offer profound, safe and natural mood elevation.”
During an interview with Street Spirit in August 2005, in-
vestigative author Robert Whitaker described the dangers of
psychiatric drugs. “When you look at the research literature,
you find a clear pattern of outcomes with all these drugs,” he
said, “you see it with the antipsychotics, the antidepressants, the
anti-anxiety drugs and the stimulants like Ritalin used to treat
ADHD.”
“All these drugs may curb a target symptom slightly more
effectively than a placebo does for a short period of time, say
six weeks,” Whitaker said. However, what “you find with every
class of these psychiatric drugs is a worsening of the target
symptom of depression or psychosis or anxiety, over the long
term, compared to placebo-treated patients.”
“So even on the target symptoms, there’s greater chronicity
and greater severity of symptoms,” he reports, “And you see a
fairly significant percentage of patients where new and more
severe psychiatric symptoms are triggered by the drug itself.”
But what Whitaker is saying now is nothing new. Uncor-
rupted medical professionals have tried to warn the public about
this problem for years. For more than a decade, Dr. Peter Breg-
gin said, “I have documented in books and scientific reports
how this stimulation or activation profile can lead to out-of-
control behavior, including violence.”
“Evidence from many sources confirms that selective sero-
tonin reuptake inhibitors commonly cause or exacerbate a wide
range of abnormal mental and behavioral conditions,” Dr.
Breggin reported in the International Journal of Risk & Safety
in Medicine 16 (2003/2004). “These adverse drug reactions
include the following overlapping clinical phenomena: a stimu-
lant profile that ranges from mild agitation to manic psychoses,
agitated depression, obsessive preoccupations that are alien or
uncharacteristic of the individual, and akathisia,” he said.
“Each of these reactions can worsen the individual’s mental
condition and can result in suicidality, violence, and other
forms of extreme abnormal behavior,” Dr. Breggin warns.
So in plain language, this means that rather than correcting
the illusive “chemical imbalance,” these widely prescribed
drugs themselves disrupt the brain’s chemistry.
Whitaker told Street Spirit that the rate of Americans being
diagnosed disabled due to mental illness has skyrocketed since
use of SSRIs began. He reports:
(1) the number of mentally disabled people in the US has been
increasing at a rate of 150,000 people per year since 1987;
(2) that represents an increase of 410 new people per day being
disabled by mental illness.
(3) the disability rate has continued to increase and today, one
in every 50 Americans is disabled by mental illness;
The statistics above beg the question of how could this hap-
pen when all the so-called “wonder drugs” flooded the market
during the same time frame. The truth is, the “wonder drugs”
are the cause of many of the bizarre behaviors listed by doctors
to warrant a diagnosis of mental illness disability.
Whitaker says SSRIs play a dual role in transforming
healthy people into disabled individuals because an SSRI pa-
tient often suffers a manic or psychotic episode as a side effect
of taking the drug; but instead of viewing the adverse reaction
for what it is, the patient's diagnosis gets changed to bipolar
disorder or schizophrenia, after which the patient is prescribed
an antipsychotic, along with the SSRI, in what Whitaker refers
to as a “drug cocktail.”
The prescribing of a drug cocktail places the patient on a fast
track to permanent disability and converts the patient into a life-
long customer of the pharmaceutical-psychiatric-complex.
Since the first SSRI, Prozac, came on the market in 1987, the
number of people diagnosed disabled by mental illness in the
US has gone from 3.3 million to 5.7 million, according to
Whitaker R, Anatomy of an Epidemic: Psychiatric Drugs and
the Astonishing Rise of Mental Illness in America; Ethical Hu-
man Psychol and Psychiatry 2005; 7:23-33.
In addition to all the other problems with SSRIs, the drugs
are addictive. In June 2003, Glaxo-SmithKline removed labels
that said their drug Seroxat was not habit-forming after thou-
sands of patients claimed they had become addicted to it.
In October 2004, the FDA ordered Black Box warnings on
SSRIs for children, and drug makers were instructed to include
the following in package inserts: “Clinical Worsening and Sui-
cide Risk: Patients and their families should be encouraged to
be alert to the emergence of anxiety, agitation, panic attacks,
insomnia, irritability, hostility, impulsivity, akathisia, hypoma-
nia, mania, other unusual changes in behavior, worsening of
depression, and suicidal ideation, especially early during anti-
depressant treatment and when the dose is adjusted up or down.
Families and caregivers of patients should be advised to ob-
serve for the emergence of such symptoms on a day-to-day ba-
sis, since changes may be abrupt.”
In June 2005, the FDA issued a Public Health Advisory on
“Suicidality in Adults Being Treated with Antidepressant
Medications,” and said adult patients “should be watched
closely for worsening of depression and for increased suicidal
thinking or behavior. Close watching may be especially impor-
tant early in treatment, or when the dose is changed, either in-
creased or decreased.”
But the FDA should do more than merely warn the public
when hidden reports surface involving dangerous drugs. The
FDA should investigate each and every case and punish the
drug company officials responsible for causing injury and death
by allowing dangerous drugs to be sold for the sole purpose of
increasing profits.
In September 2005, British regulatory officials instructed
doctors to never prescribe SSRIs to children without providing
psychotherapy as well. They were also told to never prescribe
the medications without trying other alternative drugs first, and
to not prescribe Effexor or Paxil to children under any condi-
tion.
Tim Kendall, a British psychiatrist, led a 2-year analysis of
both the published and hidden studies on SSRIs and the results
of the analysis is what motivated UK officials to ban the use of
Paxil and Effexor by children altogether and to severely restrict
the use all other SSRIs. The long-term effects of these drugs
still remain virtually unknown.
Yard Sale - State Officials Cheap
Over the last several years, with groups and programs like
the NFC, TMAP, and TeenScreen, all working together, pharma
has managed to compromise a whole network of government
officials all across the US.
According to Pennsylvania investigator turned whistle-
blower, Allen Jones, “the pharmaceutical industry has system-
atically infiltrated the mental health service delivery system of
this nation.” Jones was an Investigator in the Office of Inspec-
tor General (OIG), Bureau of Special Investigations, when a
TMAP model was being implemented in PA.
Jones says TMAP is “part of a large pharmaceutical market-
ing scheme designed to infiltrate public institutions and influ-
ence treatment practices.” A state’s adoption of the program
requires that all patients coming in contact with state systems
are to be treated with the listed drugs only, regardless of a pa-
tient’s history of success with other drugs.
Once the TMAP was set up in Texas, the Johnson & John-
son foundation provided a $300,000 grant for the sole purpose
of convincing other states to adopt a TMAP model. To that end,
Johnson, and many other drug makers, paid for meetings to be
set up with key state officials, who controlled funding for men-
tal health services in their respective states, to sell officials on
adopting a TMAP model.
As the marketing scheme spread to other states, it was only
mentioned briefly in the mainstream press. In May 2004, the
New York Times reported that drug companies were using new
strategies to capture the Medicaid and Medicare markets that
involved a “focus on a much smaller group of customers: state
officials who oversee treatment for many people with serious
mental illness.”
“Those patients—in mental hospitals, at mental health
clinics and on Medicaid” the Times wrote, “make states among
the largest buyers of anti-psychotic drugs.”
On June 27, 2004 another NYT article reported: “In the mid-
1990s, Pharma developed a new set of marketing techniques for
dealing with local government officials. A group of drug com-
pany giants, led by Johnson & Johnson, has worked to convince
state officials that a new generation of antipsychotic drugs, like
Risperdal, Zyprexa and Seroquel are superior to older and
cheaper drugs like Haldol.”
“The marketing campaign has led a growing number of
states to adopt prescribing guidelines for treating schizophrenia,
bi-polar and other disorders that make it difficult for doctors to
prescribe anything other than these very expensive drugs,” the
Times wrote.
The Pennsylvania Medication Algorithm Project (PennMap),
was adopted by the Department of Public Welfare (DPW), Of-
fice of Mental Health and Substance Abuse Services
(OMHSAS) in 2002, and was fully implemented in January
2003. In response to a request for an interview, Allen Jones
provided the details of his investigation into pharma’s influence
on Pennsylvania officials which lead to state’s adoption of
PennMap.
The shady aspects of program emerged quickly Jones said:
(1) The recommended drugs were exclusively new, patented
and expensive; (2) The drugs were selected by expert consensus
of persons with financial ties to Pharma; and (3) The claims of
increased efficacy and safety made by the drug companies, and
State employees getting perks from the companies, was contra-
dicted by the available science.
Jones discovered that the drugs mandated by PennMap were
neither safe nor effective. “The pervasive manipulation of clini-
cal trials, the non-reporting of negative trials and the cover-up
of debilitating and deadly side effects, render meaningful in-
formed consent impossible by persons being treated with these
drugs,” Jones found.
Though his investigation, Jones determined that the same
state officials responsible for writing the PennMap guidelines,
were receiving money from drug companies with a financial
stake in the outcome.
When charged with examining the receipt of drug company
funds by state employees, he “began to look at the overall issue
of Pharma marketing and immediately became alarmed that
tactics used in marketing to the private sector were being repli-
cated with public employees,” he said.
Jones discovered a hidden slush fund account, "into which
pharmaceutical companies were paying money that was being
accessed by state employees,” Jones said. “They were given
unrestricted educational grants that were deposited into an off-
the-books account, unregistered, unmonitored, literally operated
out of a drawer,” he added.
Jones also “found that various pharmaceutical companies
were paying state employees directly and also giving them
perks such as lavish trips, meals, transportation, and honorari-
ums of up to $2,000 for speaking in their official capacities at
drug company events,” he said.
“It is illegal for a public employee to accept honorariums
and to consult with industry without permission, yet it was hap-
pening openly,” he explained.
Charles Currie, the Deputy Secretary of the Office of Mental
Health and Substance Abuse Services, in the relevant time
frame, was appointed by then Governor, Tom Ridge, to a key
position even though he lacked medical credentials. It was Cur-
rie who approved the off-the-books account that became the
basis of the initial OIG investigation, and the receipt of “educa-
tional grants” intended to promote the TMAP agenda.
The OIG received reports that pharma sales representatives
were frequently and openly making gifts of meals and sporting
event tickets to state officials and state hospitals during Currie’s
tenure.
The decision to adopt PennMap was made during Currie’s
reign, and shortly after PennMap was implemented, Bush ap-
pointed Currie to head the Substance Abuse and Mental Health
Services Agency (SAMHSA), where he worked to further ex-
pand TMAP. In 2002-2003, SAMHSA had a $500,000 budget
for the express purpose of aiding TMAP development, Jones
said. Currie was also appointed to serve on Bush’s New Free-
dom Commission.
Steven Fiorello was the Director of the Pharmacy Services
Office of Mental Health and Substance Abuse Services in
Pennsylvania and quickly became the main target of the Jones
investigation.
Fiorello was the Chairman of the Formulary Committee that
approves or disapproves drugs for the state formulary and de-
scribes himself as the “Point Man” for any company wishing to
have their product added to the state formulary.
In an April 2002 Janssen Drug Company publication, under
“Faculty Bio,” Janssen describes 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.”
According to Jones, over time, Fiorello solicited educational
grants from pharmaceutical companies totaling at least $13,765.
Part of the money was used to bring Texas official and TMAP
promoter, Steven Shon, to Pennsylvania to sell the TMAP
model, and part was spent on trips to New Orleans for Fiorello,
and OMHSAS Psychiatric Services Manager, Dr. Robert Davis,
to meet with TMAP promoters and marketing representatives
from Janssen.
In late 2001, at Janssen’s request, Fiorello traveled to Phila-
delphia to promote PennMap to a group of community based
managed care providers, and he also went to Philadelphia an-
other time as a pharmacy consultant to Janssen.
On April 17, 2002, Fiorello and Dr. Fredrick Maue, Chief of
the Clinical Services Division, for the Pennsylvania Department
of Corrections, gave a presentation on PennMap at a Janssen-
sponsored event in Hershey, PA.
Fiorello was paid $2,000 for the presentation, delivered in
his official state capacity.
A Janssen sub-contractor, Comprehensive NeuroSciences
(CNS), arranged the Hershey event for Janssen and a Janssen
sales representative attended.
Documents unearthed by Jones in his investigation showed
that CNS and Janssen personnel actually prepared and reviewed
Fiorello’s materials for the presentation. CNS sent Fiorello
slides from the previous year to use as a template.
According to Jones, “The presentation materials gave formu-
laries, dates, and numbers of state hospital patients involved,
and clearly tied the Pennsylvania Program to the identical pro-
gram in Texas.” This involvement was in direct violation of
AMA regulations and FDA Guidelines for Industry, Jones said.
As another favor to Janssen, Fiorello conducted “retrospec-
tive analysis” of patient records from the state hospital system.
He essentially mined the records for information favorable to
Janssen and compiled a report. He then went to New Orleans to
present the report to a meeting of pharmacists from all over the
country with all expenses paid by Janssen.
During the implementation phase of PennMap, Fiorello also
gathered data regarding off-label experiments with dosages of
atypical medications that were higher and/or lower than the
FDA approved dose listed in the Physician’s Desk Reference.
In addition, he gathered data on the off-label use of medications
for illnesses which were not FDA approved.
Fiorello then entered this information into a computerized
data collection system that was provided, at least in part, by
pharmaceutical companies, and he later relayed the results
drawn from patient’s records to the drug companies.
During his investigation, Jones discovered that Pfizer also
had Fiorello on its payroll. On Pfizer’s behalf, Fiorello traveled
as a consulting pharmacist to Maryland with Pfizer representa-
tives, where he met with his counterpart in the Maryland De-
partment of Mental Health to discuss the implementation of a
TMAP model in Maryland.
Fiorello also traveled to Pfizer’s world headquarters in Man-
hattan 3 times to participate on an “advisory council" with all
expenses paid for by Pfizer, including lodging at Manhattan's
Millennium Hotel. Fiorello was paid an honorarium of $1,000
for attending each advisory council meeting.
Another key official, Robert Davis, MD, was the Psychiatric
Physician Manager of the Pennsylvania Medical Services Divi-
sion of the OMHSAS. Janssen paid all expenses for Davis to
attend two functions in New Orleans with Fiorello.
Davis also attended dinner meetings with Fiorello and
Janssen representative and participated in Fiorello’s analysis of
patient data, the formulation of the “study report,” and the dis-
semination of information to drug companies.
Information Jones provided to his superior in the OIG
clearly established that state employees were experimenting on
mental health patients and reporting the results to drug compa-
nies, yet Jones was not permitted to question Davis about his
pharma affiliations or his role in data gathering and its trans-
mission to drug companies.
Another key official, Steven Karp, was the Medical Director
for the Office of Mental Health and Substance Abuse Services
within the Pennsylvania Department of Public Welfare. Karp
was recruited from private industry by Charles Currie and was a
supervisory level above Fiorello.
According to Jones, Karp knew about Fiorello’s association
with Janssen, his gathering of patient information, and the dis-
semination of that information to drug companies.
While in the private sector, Karp often gave presentations
for drug companies for which he received honorariums and paid
expenses. In 2000, he was appointed to an advisory board for
the publication known as Mental Health Issues Today (MHIT).
The Parexel International Corporation is a pharma front
group and has a contract with Janssen to produce the MHIT
publication, which means Janssen funnels money to the corpo-
ration and Parexel writes the checks, Jones discovered.
As an advisory board member, Karp was invited, at Par-
exel’s expense, to attend periodic board meetings. On June 23-
25, 2001 he attended a meeting at the Mayflower Park Hotel in
Seattle, Washington and using Parexel as a funnel, Janssen pro-
vided airfare, lodging and sustenance as well as reimbursing
Karp for his expenses in getting to the airport.
On November 17-19, 2002, Karp attended a meeting at the
Hyatt Regency in Tampa, Florida, again with Janssen covering
his expenses via Parexel, and in June or July of 2002, Karp at-
tended a meeting in Chicago with all expenses paid by Janssen,
via Parexel.
A list of attendees at these events reveals a membership
comprised almost exclusively of state mental health directors,
Jones reports.
As a result of his participation in these meetings, Karp was
quoted in articles published in Mental Health Issues Today, and
achieved a degree of notoriety in his profession. Janssen, via
Parexel, funded the publication and the distribution of the arti-
cl -
Thanks for this info, Susie and Marilyn.
I am just speechless and shaking my head here. . .
-
Me too, it boggles my mind that industries play with human lives so carelessly for profit.
What's the average person to do, it's just so much bigger than we are.
If the profit driven segment was removed, I think the situation would improve dramatically. I just don't think I'll see it in my lifetime.
-
Are Dr.'s now on the phones telling their patients not to take Zetia any more? Or Vytorin? Not mine. Or maybe a letter in the mail? I'll wait for mine that won't show up. Meanwhile, I've stopped taking zetia as of last night and took a placebo instead.
-
What was the placebo, Rosemary? LOL
I think my husband takes Vytorin. It seems that Lipitor failed him OR he failed it (if you know what I mean). I'll be calling his doctor's office later. I would think his office phone is ringing off the hook. Or, maybe not. Some people do not read this stuff.
Shirley
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Your right Rosemary. It's buyer beware and that just is not right. But doesn't the press have federal funding for community service announcements? Wouldn't this fit to that requirement?
I want to know too...what was the placebo? chocololate? No, I know ... wrong answer.
Shirley, I'm ready for that new country...how about you? A country where the watchdogs are not foxes in the hen house. BTW the US is not alone in this type of problem. I don't know that a country exists today that does not deal with these types of problems...we simply can see them faster via Internet.
I'd like to see a debate of the presidential candidates specific to the issues raised by Ms. Pringle. Do you think it is possible? It would go a long way to determining the depth of the problems and how to rebalance them?
-
Don't expect your doc to call everyone on a drug that might be troublesome much less one that just doesn't do what it's touted to do (see my post on the other thread about this - there are so many drugs that lower cholesterol but don't prevent heart attack or lower blood sugar but don't prevent heart attack - remember Avandia this summer?). Even with electronic medical records (tho I'm not familiar with all of them) there really isn't a way to identify every patient who is on a certain treatment. Remember, as much as we don't like to think of it we're only one of thousands of people/large paper charts in an office.
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KISS just came to mind.
These are all prescription drugs that require a pharmacy to dispense them.
I'd bet dollars to donuts that the computer system of the pharmacy could track to the patient and notify them....at the pharmaceutical manufacturer's expense....of course.
-
My placebo was a nice glass of cabernet from Pine Ridge. And it tastes better with a little piece of chocolate cake. I had to get that cake gone. So I killed my bones, but my heart felt a lot better.
I don't think anyone will get a letter to stop taking zetia cause it isn't killing anyone. It's just adding extra plaque into the arteries, I could do that all by myself. Overtime, I'm sure this could be a problem, but not nothing the Dr.s don't love doing anyway. Let's get that stent in place right away.
-
If anyone receives the AARP monthly Bulletin, there's a great article about pharmacy and doctor relationships in this month's issue.
Don't know if it's available online.
Try this:
http://www.aarp.org/bulletin/yourhealth/drug_rep_ties_that_bind.html
-
Since I don't live in the States, I am taking the most popular statin here for lowering cholesterol...no real name other than simvastatin. Now..isn't that what lipitor is?
I'm confused...lowering cholesterol will not lower risk of heart attack or stroke? I will say that here they don't push drugs as quickly as they do in the States and doctors don't get bribed with all kinds of gifts so we get prescriptions cuz we need them and the doctors prescribe them according to what studies show.
I mean...my orthopedic doctor refuses to suggest I take calcium supplements despite the fact that I'm over 50.
So, I'm confused about these articles...my neuro-opththalmologist told me it's important to keep my cholesterol down as I'm a risk for a stroke for other reasons and I don't need that, as well.
As for anti-depressants..I would guess that some people don't really need them and that is why they aren't working...over prescribed.
-
Thanks Terry...that was encouraging...however, the FDA needs to clean house too.
-
Simvastatin is Zocor. What we really need to know about using these statins, do they prevent build-up of plaque? Does getting our cholesterol down prevent that build-up?
That's what I thought these drugs were doing. Now I don't know what to think.
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