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Subject:   

Zyprexa, the FDA, the NYTimes, and the American Psychiatric Association
Date:    Apr 25, 2007 6:00 PM
TIMES ARTICLE BELOW

Ely Lilly promoted Zyprexa for use in dementia patients, when that is against the
American Psychiatric Association's Guidelines for the treatment of a delirium
or a dementia, yet no one from the APA said a thing about it to the drug-pushers?
(I mean, He-who-bears-the-fried-rice?)

Here is a genuine APA webpage, which a "law enforcement person" could 
subpoena, just as they could subpoena Yale's Ben Bunney's old homepage and
find that I have a genuine copy of what was on his website (Bunney's expertise
is the brain damage caused by psychotropics):
http://www.actionlyme.org/MALPRACTICE_TREATMENT_OF_LYME.htm

http://www.actionlyme.org/JAMES_PHILLIPS_MALPRACTICE.htm
It's not like I did not give him my brain scans, bloodwork, my spinal fluid 
analysis which showed the actual OSPA antigen (a fragment of the actual Lyme spirochete
and not an antibody)  in my spinal fluid, and evidence that my kids were congenitally
infected.  

That asshole James Phillips acted like the whole world's problems were my fault.
http://www.actionlyme.org/KATHLEEN_3_BRAIN_SCANS.htm  (Lyme is a relapsing-remitting
brain disease, as my relapsing-remitting brain scans demonstrate, and is asssociated
with Multiple Sclerosis- which I have, as per scientifically valid EMGs... nerve
damage to all four limbs.  Are we to believe I  hypochodriac-tomized my own damaged
nerve conduction studies?)

http://www.actionlyme.org/BUNNEY_YALE_BRAIN_DAMAGE.htm  ("Ho hum.  People are
too stupid to know that movement disorders are the same thing as Parkinson's
or brain cell loss...")


http://www.actionlyme.org/PHILLIPS_BRANSFIELD_MMI.htm  (Tawkin ta dot guv dopes 
seems to be my hobby, eh?)

http://www.actionlyme.org/COWARDLY_PSYCHIATRIC_WUSS_TEAM.htm  [Psychiatrist Michael
Schwartz says he wanted to punch Allen Steere in the face.

Jeepers, I hope Dr. Shwartze doesn't get arrested and charged with being a stalker
and terrorist:
http://www.vaccinationnews.com/DailyNews/June2001/StalkDocSteereReLymeDis.htmist.

I hope Mark Klempner doesn't think he now has to drive in a Popemobile instead
of just wearing a "bullet proof vest," as he falsely claims, just because
Michael Schwartz did not want to be brain damaged from Lyme/Syphilitic dementia 
(they are the same thing).]


http://www.actionlyme.org/070326homepage.htm
That data on that homepage is only for persons with an iota of self respect and 
care to look up the MedLine-linked journal articles which show that all psychotropics
are brain damaging.  (Scroll to the bottom.  The articles are in the lower half 
of the page.)


So.

Ely Lilly definitely pulled a fast one, but that is because psychiatry does not 
care if they further brain-damage people, because they view everyone as bad- like
themselves.

"There is no value-free or presuppositionless orientation in this field"-
James Phillips.

Correct, Jim.  Psychiatry is all psychiatrist-projected bullshit.  The garbage that
comes out of their own minds, they infer belongs to the victims they "diagnose,"
and they call that a medical practice.

What the drug reps do, in reality, is that they tell these psychiatric idiots that
"We have preliminary data which shows that such and such drug can be used for..."

But it doesn't really matter, because no mental disease is really a disease,
except where they really are diseases of the brain, like HIV, Lyme, and Alzheimer's.


How many people know that a US Military pilot is grounded for life if they get HIV?
Are we expected to believe that that is because suddenly these pilots are not getting
enough sex and are therefore CRAZY???


Yet Yale says we don't have a real disease, we're just CRAZY?  When the 
entire combined National Institutes say Lyme brain and HIV brain belong to the same
group of immune-mediated diseases of the brain?
http://intramural.nimh.nih.gov/inip/call4proposals.htm


This is such a winnable lawsuit against Ely Lilly, that it should set up a protocol
to slam the rest of BigPharma on their entire class of bullshit psycho drugs, since
all anyone has to do is get the president of the APA in a witness stand and ask 
him/her:

"So, what tests do psychiatrists routinely prescribe to rule out a dementia
process before diagnosing someone as insane?"

He/she will have no answer.

http://www.actionlyme.org/BIOMARKERS.htm

And that no-answer slams back against all of BigPharma.

Think about it.


Oh, and the reason Zyprexa causes diabetes is because it is a co-histamine blocker.
There is too much sugar in the blood, and it cannot be modified by diet changes 
as the morons at the APA recommend.


http://www.actionlyme.org/FDA_DISCLAIMS_JOB_RESPONSIBLITY.htm
FDA officially directs me to the page which says "WE DON'T HAVE TO LOOK
AT ANY OF THE DATA BIG PHARMA SENDS US."


"Or, Sorry.  We thought that's what we were paying you to do.

"Sorry.  Next time we'll go to the witch doctor, since eye-of-newt and 
wing-of-bat has the same level of dot guv oversight buts costs less."


KMDickson
ActionLyme.org
Former BigPharma
------------------------------------------------
The New York Times
Printer Friendly Format Sponsored By

April 25, 2007
U.S. Wonders if Drug Data Was Accurate
By ALEX BERENSON

The Food and Drug Administration is examining whether Eli Lilly & Company provided
it with accurate data about the side effects of the antipsychotic drug Zyprexa, 
a potent medicine that has been linked to weight gain and diabetes.

The F.D.A. has questions about a Lilly document from February 2000 in which the 
company found that patients taking Zyprexa in clinical trials were three and a half
times as likely to develop high blood sugar as those who did not take the drug.

That document was not submitted to the agency. But a few months later, Lilly provided
data to the F.D.A. that showed almost no difference in blood sugar between patients
who took Zyprexa and those who did not.

The F.D.A. confirmed its inquiry in response to questions from The New York Times.
The agency said it had not yet decided whether to take any action against Lilly.

“The F.D.A. continues to explore the concerns raised recently regarding information
provided to the F.D.A. on Zyprexa’s safety,” Dr. Mitchell Mathis, a deputy director
in the psychiatry division of the agency’s center for drug evaluation and research,
said.

A Lilly spokesman, Phil Belt, said the company had rechecked its database and found
errors in the original statistics. The data submitted later was accurate, Mr. Belt
said.

But the 2000 document said that its figures had already been checked for error. 
The Times disclosed the existence of the document in an article last December.

The discrepancy between Lilly’s initial data and what it later submitted came at
a time when Zyprexa’s sales were soaring, even as some doctors and foreign regulatory
agencies were questioning the drug’s safety.

The F.D.A. has never concluded that Zyprexa causes diabetes more than other widely
used psychiatric drugs, although the American Diabetes Association has.

Zyprexa remains Lilly’s top-selling drug, with $4 billion in worldwide annual sales.
But prescriptions in the United States have fallen nearly 50 percent since 2003 
amid the safety concerns.

Zyprexa and other antipsychotics are intended to quell the hallucinations and delusions
associated with schizophrenia and to treat some cases of mania.

The document from 2000 and others were provided to The Times by James B. Gottstein,
a lawyer who represents mentally ill people he says are forced to take psychiatric
medications against their will.

Besides the F.D.A. inquiry, Lilly is facing federal and state investigations into
the way it marketed and promoted Zyprexa. The company has already agreed to pay 
$1.2 billion to settle 28,500 lawsuits from people who contend that they developed
diabetes or other diseases after taking the drug. At least 1,200 more lawsuits are
pending.

Mr. Belt, the Lilly spokesman, said in a statement that the company properly marketed
Zyprexa and disclosed its side effects to the F.D.A. and doctors.

“Lilly always cooperates fully with requests for information from the F.D.A.,” he
said, “and that includes any requests regarding information on Zyprexa. Lilly is
forthcoming with all relevant clinical data on all of our products.”

Lawyers who represent drug companies said the F.D.A. largely depended on the companies
to be honest about the side effects of their drugs. With a staff of fewer than 3,000,
including support personnel, the agency’s drug division oversees more than 12,000
prescription medicines and 400 nonprescription drugs.

In most cases, said William W. Vodra, senior counsel at the law firm of Arnold &
Porter and a former F.D.A. associate chief counsel, it does not perform detailed
audits of clinical trials or independently check the integrity of the data that 
companies send to it.

“There’s no way they could police the system with the resources they have,” Mr. 
Vodra said. Companies provide the agency’s scientists with so much information that
“there is a point at which you can’t even think about what they’ve given you,” he
added, “let alone what’s behind that stuff that they may not have given you.”

Robert A. Dormer, a partner in the law firm of Hyman, Phelps & McNamara, who
represents drug companies, said that the companies did not have to provide every
analysis they performed to the F.D.A. “Companies do lots of drafts of things,” Mr.
Dormer said.

The Zyprexa document that has aroused the most interest at the F.D.A. is a Feb. 
21, 2000, paper in which Lilly scientists discussed whether Zyprexa’s label should
be changed to alert doctors of the risk of hyperglycemia, or high blood sugar, associated
with the drug.

The paper showed that 154 of 4,234 patients, or 3.6 percent, who took Zyprexa in
clinical trials developed high blood sugar. Only 1.1 percent of patients who took
a placebo developed the condition.

Doctors have said that difference is worrisome because most patients in the clinical
trials were taking Zyprexa for only a few weeks or months. Untreated hyperglycemia
can eventually lead to diabetes, a disease in which the body’s insulin-producing
cells die and patients lose the ability to regulate their blood sugar. Diabetes 
is the sixth-leading cause of death in the United States.

The data that Lilly provided to the F.D.A. was notably different from the results
discussed in the February 2000 paper, with the gap between the two patient groups
much narrower. The company told the agency that patients taking Zyprexa developed
high blood sugar at a 3.1 percent rate, while those taking the placebo had a 2.5
percent rate.

Mr. Belt said that after the February 2000 paper, Lilly performed a final quality
check of the data and discovered that some patients had been incorrectly included
in the analysis, while others had been excluded.

“The original data referred to in the memo was a preliminary analysis, not the final
accurate analysis that was provided to the F.D.A., and is therefore very misleading,”
he said.

The Times reported in December on the existence of the February 2000 document, as
well as other company documents and e-mail messages that contradicted public statements
by Lilly about Zyprexa’s risks.

Lilly has said that the documents and e-mail messages were taken out of context 
and do not present a balanced view of Zyprexa’s risks and benefits. A federal judge
has criticized The Times for violating a protective order that covered the documents.

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