Sunday, July 20, 2008


Anti-smoking drug study investigated
Audrey Hudson (Contact)
Sunday, July 20, 2008

Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and whether the study will be ended.

Dr. Tom Puglisi, chief officer of the VA's Office of Research Oversight, says he has several concerns that veterans suffering from post traumatic stress disorder (PTSD) were prescribed the smoking-cessation drug Chantix without receiving timely written information or warnings about its possible side effects, which can include psychosis and suicidal behavior.

Dr. Puglisi said he also is concerned that similar notification problems exist throughout the agency's human subject testing programs, particularly those that target participants with PTSD.

"The secretary has asked my office to look at this study in great detail, as well as all of the studies involving PTSD patients, and we will make very specific recommendations about how the system needs to be changed to make sure this doesn't happen again, and we will make specific recommendations relative to accountability of individuals who appeared not to have fulfilled their responsibilities," Dr. Puglisi said.
go here for more

This is what Principi wrote
For the record
Washington Times - Washington,DC,USA
LETTER TO EDITOR: For the record

Sunday, July 20, 2008
Having spent more than 35 years of my professional life in public service, I must take issue with your July 9 Page One article "Principi prodded VA on Chantix."

As a combat-decorated Vietnam veteran, Republican staff director of the Senate Committee on Veterans Affairs (1984-88), deputy secretary of the Department of Veterans Affairs (1989-93), chairman of the Commission on Veterans Transition Assistance (1996-98) and secretary of the Department of Veterans Affairs - I know of few people more committed to veterans and their health and welfare than I. Therefore, it is important that I set the record straight.

The VA first lifted the co-payment requirement for veterans participating in a smoking-cessation program in 2004. I stand by that decision to help veterans quit smoking. At that time, I had no direct or indirect contact with anyone at Pfizer. The drug Chantix had not been submitted to the Food and Drug Administration (FDA) for approval, and I knew nothing of its existence.

Upon leaving office in early 2005, I entertained several employment options in the private sector. I accepted a position with Pfizer, but my tenure lasted a matter of months. In March, 2005, President Bush asked me to return to public service as the chairman of the Base Realignment and Closure Commission (BRAC).

I concluded my work on BRAC in the fall of 2005. Soon thereafter, I accepted the position as chairman of the board for a California-based company. My intention was to move West eventually. Again, Pfizer contacted me. I decided to rejoin the company in March 2006.

I first learned of Chantix after its FDA approval in May 2006. I had no knowledge of any smoking-cessation studies involving veterans with post-traumatic stress disorder until I read The Washington Times' article. I never lobbied or prodded VA on behalf of Pfizer.

For anyone to assert that any decision I made as a Cabinet secretary was designed to benefit my life after public service, or for anyone to suggest that I have used my public service for profit is not only unfair but untrue.

My decision to resign from a senior executive position with Pfizer after two months to return to public service as chairman of BRAC is evidence of my willingness to put public service above self.

If The Washington Times believes we, as a nation, need to further review the employment options available to former members of any administration, so be it. But the facts simply do not support The Washington Times using this former Cabinet secretary to support its case.


Easton, Md.

It's hard to believe that all of this went on while no one seemed to care about any of this. I did some checking to see what was known and when it was known other than what has already been posted on this blog. The first thing I discovered was a report from 1996. Not about this drug, but what was found by Pfizer looking at the brain and stress. Just one more time where researchers are researching what was already studied when you think of the reports that have come out over the last few years. This study was done by Pfizer in 1996.

Sep 16, 96
15:56 ET
Pfizer Scientists Discover Chemical Block For Brain's Response To Stress
Pfizer Scientists Discover Chemical Block For Brain's Response To Stress
Discovery holds potential for new generation of drugs for depression, anxiety
/ADVANCE/ GROTON, Conn., Sept. 16 /PRNewswire/ -- Scientists at Pfizer
Central Research have designed a molecule that blocks the cascade of events in
the brain that occur in response to stress. Described in this week's
Proceedings of The National Academy of Science, the discovery molecule can be
administered orally, and has been shown in preclinical experiments to have
potential for treating depression and anxiety.
The Pfizer compound arrests the action of a neurotransmitter,
corticotropin releasing factor (CRF), which scientists believe is an important
chemical messenger for transmitting the stress response in the brain.
Excessive levels of this chemical signal may ultimately produce a host of
central nervous system disorders such as depression, anxiety, anorexia and
post-traumatic stress disorder.
"This breakthrough Pfizer compound has implications as a revolutionary
tool for researchers," said George M. Milne, Jr., Ph.D., president of Pfizer
Central Research. "This first non-peptide CRF antagonist should offer an
opportunity, for the first time, to probe the important function of CRF in the
brain. The compound could ultimately emerge as a novel therapy for treating
depression, anxiety and other diseases triggered by increased CRF activity."
Dr. Milne emphasized that while this is a pathfinding scientific discovery, it
will be some years before it is determined whether it will yield a new drug
that is available to patients.
Research has shown that patients with stress-related conditions have a
high concentration of CRF in their cerebrospinal fluid and that CRF levels
decrease following treatment with antidepressant therapies. The challenge for
scientists seeking to block CRF's activity has been to discover a small
molecule that is both effective and can penetrate the blood-brain barrier, a
membrane filtering system that permits entry of some chemicals into the brain
while denying access to others.
Although there have been reports of compounds that successfully block the
CRF receptor--the site on the nerve cell where CRF binds--these compounds have
been large peptide molecules, incapable of crossing the blood-brain barrier.
These drugs could only be administered by direct injection to the brain, and
thus have no practical utility as a medicine.
The report published today describes key attributes of the Pfizer
molecule: Its potency (determined by its ability to bind to CRF receptors and
block CRF's activity at very low concentrations); its unique ability to
penetrate the blood-brain barrier; and its selectivity for the CRF receptor
(decreasing the chances of side effects that can result when numerous
receptors are blocked simultaneously). Finally, preclinical tests, according
to the study, show that the compound has strong anxiolytic and anti-depressant
Where previous blockers of CRF's effect, could not be developed into
practical medicines because they were peptides, the Pfizer compound is the
first CRF antagonist that is a small non-peptide molecule. "This is the first
non-peptide antagonist of CRF receptors," the authors wrote, "and possesses
clear pharmaceutical advantages over peptide antagonists."
Pfizer Central Research, with major worldwide research facilities in
Groton, Connecticut; Sandwich, England; Amboise, France; Nagoya, Japan; and
Terre Haute, Indiana, is the principal pharmaceuticals, and animal health
research and development arm of Pfizer. Pfizer Inc (NYSE: PFE) is a research-
based health-care company with global operations. In 1995, the company
reported sales of over $10 billion and, in 1996, expects to invest
approximately $1.7 billion in research and development.
SOURCE Pfizer Central Research

This is when they announced Zoloft.

Dec 07, 99
13:48 ET
Pfizer Drug Zoloft(R) Receives FDA Approval For Treatment of Posttraumatic Stress Disorder
Pfizer Drug Zoloft(R) Receives FDA Approval For Treatment of Posttraumatic Stress Disorder
NEW YPRNewswire/ -- Pfizer Inc (NYSE: PFE) said today that
the U.S. Food and Drug Administration approved its anti-depressant Zoloft(R)
(sertraline hydrochloride) for an indication of posttraumatic stress disorder
A selective serotonin reuptake inhibitor discovered and developed by
Pfizer, Zoloft is the first medicine to receive a FDA approval for the
treatment of PTSD. Symptoms of PTSD may develop following any extreme
traumatic event in which there was threatened death or serious injury, and the
individual's response involved intense fear, helplessness or horror. Such
events may include physical and sexual abuse and natural disasters.
Approximately 50 percent of the general population are exposed to a
traumatic event during their lifetime. Ten to twenty percent of those develop
PTSD. The prevalence of PTSD is twice as high in women as in men. Symptoms
can include persistent intrusive thoughts of the event, flashbacks, overall
emotional numbness, or being easily startled.
"Patients suffering from PTSD experience significant distress or
impairment in normal functioning," said Dr. Joseph Feczko, Senior Vice
President, Pfizer Inc. "In clinical trials, Zoloft was shown to have
considerable impact on these symptoms, thus giving physicians a new treatment
option for this major medical need."
"Pfizer's commitment to innovative research and development is reflected
in the approval of Zoloft for the treatment of PTSD," said Karen Katen,
President, U.S. Pharmaceuticals. "In an effort to improve the quality of life
of those suffering from this debilitating illness, we intend to launch a
broad-based campaign to educate and increase awareness among health care
professionals and consumers that PTSD is a treatable medical condition."
Zoloft is currently indicated for major depression, panic disorder, and
obsessive-compulsive disorder. More than 100 million prescriptions for the
medicine have been written in the United States since its launch in 1992.
Zoloft is contraindicated until at least 14 days have passed since
discontinuing a monoamine oxidase inhibitor (MAOI) and a MAOI is
contraindicated for at least 14 days after discontinuation of Zoloft. MAOI's
are usually used to treat depression and related conditions. A patient should
never take Zoloft while taking MAOI's. The most common side effects of Zoloft
include nausea, insomnia, diarrhea, ejaculation problems (mainly ejaculatory
delay) and somnolence. Full prescribing information is available upon
Pfizer Inc is a research-based global pharmaceutical company that
discovers, develops, manufactures and markets innovative medicines for humans
and animals. The company reported revenues of more than $13.5 billion in 1998
and expects to spend about $2.8 billion on research and development this year.
In 1999, Pfizer celebrates its 150th anniversary.

Just goes to show we have not come very far at all when we think of the newer troops still suffering today when all this was known in 1996.

As for the connection between Principi, the VA and Pfizer, who knows where this will lead. As for now, I'm sick enough just thinking about all the wasted time topping all of this off.

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