4/07/2001 – Insight Mag – Misleading Medicine

Once again Kelly O’Meara has written an incredible article. This time the
subject is the absurdity of the PMDD diagnosis and the prescribing of Prozac
repacked and renamed as “Sarafem” for that “disorder.” We have included the
first several paragraphs for you and encourage you to go to the Insight
Magazine sight to read the rest.

The article gives much insight into the lengths to which Lilly will go to
cover up the fact that Prozac and Sarafem are one in the same drug.
Apparently as long as they do not admit it publicly it is not reality?

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
http://insightmag.com/archive/200104301.shtml

InsightMag.com
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Misleading Medicine
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By Kelly Patricia OMeara
komeara@…
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Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for
women suffering from PMDD, a mental disorder not yet proved to exist.
Whats more, Eli Lilly admits that Sarafem has the same active ingredient as
Prozac, complete with the same dangerous side effects.

Australian-born singer Helen Reddys 1972 hit song I Am Woman has been
called a feminist battle hymn. Many a male disc jockey at the time refused to
air it until the song became part of the soundtrack to a movie and catapulted
to the top of the Billboard charts. Taking a look at the song today, its
hard to imagine the furor generated by the lyrics from the lady down under:
Oh, yes, I am wise, but its wisdom born of pain.
Yes, Ive paid the price, but look how much I gained.
If I have to I can do anything.
I am strong. I am invincible. I am woman.
Nearly three decades since the release of this feminist anthem the
lyrics neither threaten nor offend if they ever did but seem to
acknowledge pride in feminine strength. As if it needed to be said,
historians agree on the significance of women in the building of this nation.
The Jamestown settlement, for instance, was a disaster and on the brink of
failure until women were added to the new colony. The West was won by men and
women working side by side, and the United States triumphed over its enemies
in World War II with the help of nearly 500,000 women in the ranks and
millions more in the factories.
Not surprisingly, women achieved these feats completely unaware that a
few days out of each month they were suffering from a mental disorder. Thats
right. The Food and Drug Administration (FDA) recently approved the use of
Sarafem (fluoxetine) for women suffering from a mental disorder just three or
four days a month in the luteal phase or just before the onset of
menses.
This mental disorder which the American Psychiatric Association
(APA) has not yet accepted, but which is listed in the appendix of the APAs
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is called
premenstrual dysphoric disorder, or PMDD. Its a new-and-improved version of
premenstrual syndrome (PMS), which also has not made it to the hit parade of
the official APA list of mental illnesses. The fact that PMDD is listed only
in the diagnostic manuals appendix reflects the APAs desire for further
research before accepting it as a full-fledged mental disorder.
According to the DSM-IV and the FDA, a woman must experience five or
more symptoms before the diagnosis can be made. The unofficial mental
disorder is said to be characterized by the following symptoms:

Markedly depressed mood

Marked anxiety

Marked affectivity

Decreased interest in activities

Feeling sad, hopeless or self-deprecating

Feeling tense, anxious or on edge

Persistent irritability, anger and increased interpersonal conflicts

Feeling fatigued, lethargic or lacking in energy

Marked changes in appetite

A subjective feeling of being overwhelmed or out of control

Physical symptoms such as breast tenderness, swelling or bloating.

Eli Lilly and Co., the Indianapolis-based pharmaceutical company that
makes Sarafem, has been marketing the new treatment with such gusto that
there are jokes about the company exhibiting obsessive-compulsive disorder.
It seems there isnt a magazine to be picked up or a channel to be surfed
that isnt running a Sarafem advertisement.
These ads show women expressing many things. One TV spot depicts a
woman trying to button her slacks and looking angry and agitated. Another
scene shows a woman snapping at her husband, Just leave me alone, while
still another involves a woman slumped on the couch sobbing. Then there is
the slogan: Sarafem More like the woman you are.
Lilly reports in its ads that now, Doctors can treat PMDD with
Sarafem the first and only prescription medication for PMDD. The ad
further states that, Sarafem contains fluoxetine hydrochloride, the same
active ingredient found in Prozac. But both Sarafem and Prozac are
fluoxetine hydrochloride. According to Laura Miller, marketing associate for
Eli Lilly, Fluoxetine hydrochloride is the same active ingredient in Sarafem
as in Prozac. Again and again Insight asked, Then is it the same thing?
Again and again Miller only repeated that the two identical doses of
fluoxetine hydrochloride have the same active ingredient.
Miller refused to acknowledge that Sarafem is just Prozac repackaged,
or that the pill color was changed from green to feminine pink and lavender
to market it for a not-yet-approved mental disorder that never before
existed. The Lilly representative did say the difference in the treatments is
in how women react to the drug.
Never mind that all this dramatic hype, supported by millions of
dollars in marketing, has occurred just before Lilly loses its exclusivity on
Prozac in August. . . . to finish article go to:

http://insightmag.com/archive/200104301.shtml

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02/15/2001 – Writing May Be on Wall for Ritalin

Once again I must apologize for sending so much info at once over the next
couple of days. I have been traveling again as I work to educate more and
more areas of the country about these drugs and the articles that I have
needed to get out to you have backed up yet again.

The following is an incredible article once again written by Kelly O’Meara of
Insight Magazine. Kelly has published several very informative articles over
the last year or so educating the public about the drugging of our children.

We will work to keep you updated on all the latest on this class action suit
filed against Ritalin by the attorneys that took on the tobacco giants and
won.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.insightmag.com/archive/200010163.shtml
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10/16/2000

Writing May Be on Wall for Ritalin
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By Kelly Patricia O’Meara
omeara@…
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A lawsuit challenging the validity of the science behind mental
illness and psychotropic drugs will have repercussions for drug makers as
well as for the mental-health establishment.

Hardly a mention was made in the national media concerning the
class-action lawsuit filed in May by the Dallas law firm of Waters and Kraus.
It named the Novartis Pharmaceutical Co. (the maker of the drug Ritalin), the
American Psychiatric Association (APA) and Children and Adults with Attention
Deficit/Hyperactivity Disorder as defendants for conspiring, colluding and
cooperating in promoting the diagnosis of attention-deficit disorder (ADD)
and attention-deficit/hyperactivity disorder (ADHD).

Last week, however, a second lawsuit made a bang when even
bigger guns were rolled out in California and New Jersey to take aim at an
industry that has enjoyed a special relationship with the Clinton/Gore
administration. Indeed it is a relationship which, based on numerous speeches
by the vice president and his wife – who has been the president’s White House
mental-health guru – would continue if Al and Tipper Gore are allowed to make
the White House their new residence on Inauguration Day.

And if the beating the tobacco industry took at the hands
of these attorneys is any indication of what the defendants should
anticipate, the psychiatric community, pharmaceutical industry and
mental-health advocacy groups finally may be called upon to put their science
where their mouths are. Putting aside the legal jargon, what appears to be in
question is the ever-increasing influence of pharmaceutical companies over
public and private mental-health organizations and, ultimately, whether that
influence is responsible for the growing number of “mental illnesses” and the
subsequent increased use of psychotropic drugs.

The class-action lawsuit that was filed last week in
California and New Jersey names Novartis and the APA as defendants for
conspiring to create a market for Ritalin by targeting millions of children
and misdiagnosing them with ADD/ADHD for the strategic purpose of expanding
use of the drug.

Both the APA and Novartis have a great deal at stake
professionally and financially. To fight the claim that children have been
and still are being misdiagnosed with ADD/ADHD, the APA – the nation’s
leading psychiatric professional group – will be required to cough up its
medical and scientific data to support the ADD/ADHD diagnosis. This may be
difficult given the growing number of physicians, scientists and even
psychiatrists who long have argued that the diagnosis of ADD/ADHD is not
based in science – that the diagnosis is a fraud based on subjective
assessments.

Furthermore, should the APA fail to provide the necessary
scientific data, Novartis could be forced by the courts to return to
consumers hundreds of millions, if not billions, of dollars made from the
sale of Ritalin. Even more devastating to Novartis, should it be exposed that
the diagnosis of ADD/ ADHD is scientifically baseless, would be an end to the
prescribing of the drug. This type of judgment could open the industry to
additional lawsuits requiring proof of thousands of alleged mental illnesses.
The reverberations through the pharmaceutical industry could be devastating.

Considering that Ritalin has been in use since the
mid-1950s, one has to wonder how tens of millions of children and adults
could be prescribed a highly addictive drug for more than 40 years without
concrete scientific data to support the diagnosis. According to psychiatrist
Loren Mosher, it isn’t that tough. Mosher is the former chief of the Center
for Studies for Schizophrenia at the National Institute of Mental Health
(NIMH) and author of the definitive book Community Mental Health, A Practical
Guide. Mosher explains that the Ritalin phenomenon comes down to a very
simple theory: “If you tell a lie long enough, it becomes the truth.” Long
aware of infiltration by the pharmaceutical companies into professional
psychiatric organizations, Mosher resigned his membership in the APA with a
stinging 1998 letter in which he wrote:

“The major reason for this action is my belief that I am
actually resigning from the American Psychopharmacological Association.
Luckily, the organization’s true identity requires no change in the acronym.
. At this point in history, in my view, psychiatry has been almost completely
bought out by the drug companies.”

According to Mosher, “The APA receives a huge amount of
money from the pharmaceutical companies through grants, but the most obvious
and obnoxious examples are the two meetings the APA has each year. At both,
the drug houses basically lease 90 percent of the exhibition space and spend
huge sums in giveaway items. They have nearly completely squeezed out the
little guys, and the symposiums that once were dedicated to scientific
reports now have been replaced by the pharmaceutical-industry-sponsored
speakers.”

The National Alliance for the Mentally Ill (NAMI),
explains Mosher, “gets the pharmaceutical money and then says they spend it
on their ‘anti-stigma’ campaign. They say that mental illness is a brain
disease. And it works well for the people who suffer from this to use their
drugs. This is why NAMI is pushing for forced medication. It is an amazing
selling job on the part of NAMI.”

A nonprofit, grass-roots, self-help support and advocacy
organization for people with severe mental illness, NAMI was featured in a
November/ December 1999 Mother Jones article, “An Influential Mental Health
Nonprofit Finds Its ‘Grassroots’ Watered by Pharmaceutical Millions,” by Ken
Silverstein. The article focused on the enormous amount of funding which NAMI
receives from pharmaceutical companies, with Eli Lilly and Co. taking the
lead by donating nearly $3 million to NAMI between 1996 and 1999. In fact,
according to Silverstein, NAMI took in a little more than $11 million from 18
drug companies for that period. Nonetheless, NAMI, Eli Lilly and the others
deny any conflict of interest.

While Eli Lilly, manufacturer of Prozac, admits making
substantial contributions to NAMI and the National Mental Health Association
(NMHA), it claims that for “proprietary reasons” it is unable to provide a
list of specific contributions. According to Jeff Newton and Blair Austin,
spokesmen for the company, “The key issue here is that these are unrestricted
grants. The groups can use the money any way they want. Lilly’s support of
these initiatives presents no conflict of interest since they represent
efforts to raise public awareness around issues that Lilly publicly
supports.”

According to Bob Carolla, director of Media Relations for
NAMI, “We represent a constituency that uses their [pharmaceutical] products.
Why shouldn’t they give us money? They’re making money off of our members and
some of it has to go back into the community to help us get better
mental-health programs to help people. Much of what we do has nothing to do
with the pharmaceutical industry. We do not advocate or endorse any specific
medications or products, but we also are not going to back off from saying
that millions of Americans lead productive lives because of the medications
they are prescribed.”

Meanwhile, NAMI has no problem stating that “mental
illnesses are disorders of the brain.” In fact, according to Carolla, NAMI
“has been trying to educate people that mental illnesses are a result of
brain disorders and they are treatable. Stigmas still exist and stigmas need
to be overcome.” Asked to provide scientific data that mental illness is a
disease of the brain, Carolla deferred to a higher authority explaining that
“this [question] reminds me that one small interest group denies that mental
illness even exists.”

Carolla added, “Mental illnesses are biological brain
disorders. Go read the dominant body of medical information out there. It is
a function of biochemistry. I encourage you and recommend you talk to the
surgeon-general’s office.”
Carolla was referring to the Report on Mental Health
released by the U.S. surgeon general in December 1999, which he says “stands
as the national baseline.” This enormous document goes into great detail
about mental health in the United States. But it does not provide a single
piece of scientific data supporting the claim that even one mental illness is
caused by a brain disease. In fact, what it says is “the body of this report
is a summary of an extensive review of the scientific literature, and of
consultations with mental-health-care providers and consumers. Contributors
guided by the Office of the Surgeon General examined more than 3,000 research
articles and other materials. .”

According to the report, “The review of research supports
two main findings: 1) the efficacy of mental-health treatments is well
documented, and 2) a range of treatments exists for most mental disorders.”

Voilà! The review of research came up with findings about
treatments, not with scientific causes of mental disorders. And there even
appears to be some question about the validity of the treatments.

The surgeon general nonetheless places Ritalin in a
category where the “efficacy of mental-health treatments is well-documented,”
when in Chapter 3 of his report he writes that “because the symptoms of ADHD
respond well to treatment with stimulants,” and because stimulants increase
the availability of the neurotransmitter dopa-mine, the “dopamine hypothesis”
has “gained a wide following.”

The surgeon general may want to review the Drug
Enforcement Administration’s (DEA) 1995 report on methylphenidate, which
makes clear that Ritalin has the same effect on children and adults with ADHD
as it does upon those not diagnosed with ADHD. According to the report:

“There is a considerable body of literature on the
short-term efficacy of stimulant pharmacotherapy on the symptoms of ADHD.
From 60 to 90 percent of children have been judged as positive drug
responders to methyl-phenidate medication. However, contrary to popular
belief, stimulants like methylphenidate will affect normal children and
adults in the same manner they affect ADHD children. Behavioral or
attentional improvements with methylphenidate treatment therefore are not
diagnostic criteria of ADHD.”

NAMI, however, is not the only group apparently being
misled by the surgeon general’s report. Take, for instance, the Mental Health
Early Intervention, Treatment, and Prevention Act (S2639), a broad piece of
federal mental-health legislation sponsored by Sens. Pete Domenici, R-N.M.,
Ted Kennedy, D-Mass., and Paul Wellstone, D-Minn. According to one staffer
familiar with the legislation, Domenici’s staff took the lead in writing it.
The first of Congress’ “findings” states that “almost 3 percent of the adult
population, or 5 million individuals in the United States, suffer from a
severe and persistent mental illness.” When asked where Domenici got these
figures, the same source explained that “the numbers come from various
federal agencies, various studies that have been conducted and the surgeon
general’s report. The senator takes into consideration that there are those
who argue there is no such thing as a medically diagnosable mental illness
but, when someone like Dr. Steven Hyman [director of NIMH] shows a brain with
schizophrenia and one without, then the senator takes it seriously. Hyman is
well-respected.”

While it appears that Hyman’s “brain” slide show has wowed
a great many people, the fact is that even Hyman has contradicted his own
presentation. For instance, as Hyman explained in a Feb. 28, 1999, New York
Times Magazine article, “indiscriminate use of MRI and PET scans . as a
high-tech form of phrenology . are pretty but inconsequential pictures of the
brain.” While Domenici may place a great deal of trust in the “science”
presented by doctors such as Hyman, he also has a more personal interest much
closer to home: His wife served on NAMI’s board for nearly three years.
Domenici’s office did not respond to inquiries about whether the senator had
received campaign contributions from pharmaceutical companies.

NAMI’s Carolla openly admits that NAMI worked with the
sponsors of the legislation, and one doesn’t have to look too hard to see the
similarities between the Senate bill and NAMI’s proposed Omnibus Mental
Illness Recovery Act, which Eli Lilly paid to print.

NAMI fully supports the Senate bill, which features such
programs and expenditures as Section 581 in which $75 million would be
appropriated to fund an anti-stigma advertising campaign – which many argue
is a promotion for the pharmaceutical industry and should not be funded with
taxpayer dollars. In question also is why taxpayers should be burdened with
funding an anti-stigma campaign which many believe was created by the
mental-health community when it first began labeling individuals as
defective.

Section 582 would provide $50 million in training grants
for teachers and emergency-services personnel to recognize (read: diagnose)
symptoms of childhood and adolescent mental disorders. This would allow
service personnel such as firefighters, police officers and teachers to make
referrals for mental-health treatment – a difficult task given that each of
these categories of personnel appears to have its hands full with jobs for
which they already are trained.

Section 583 would provide another $50 million for
emergency mental-health centers within which mobile crisis-intervention teams
would be established. This would allow for the designation of a central
receiving point in the community for individuals who may be cited by, say, a
firefighter, to be in need of emergency mental-health services. And this is
just the beginning of the programs proposed under the Mental Health Early
Intervention, Treatment, and Prevention Act, now pending in Congress.

Larry Sasich, a pharmacologist who handles Food and Drug
Administration drug-safety issues for the Washington-based Public Citizen’s
Health Research Group, tells Insight that “conflicts of interest are kind of
a fact of life in the scientific community. At some point groups like NAMI
are going to have to pay the piper – they’re going to have to answer for what
they are promoting. But it’s hard to tell how much influence the
pharmaceutical companies have. It could be subtle or overt influence
depending on what they want.”

One thing that is certain, concludes Sasich: “The group that is
paying the money wields the big stick.”

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