Blowing the Whistle: A Pharmacist's Vexing Experience Unraveled "It
was clear that I could not count on any federal agency or politician to
step up to the plate. "
Date:
Tuesday, January 09, 2007 9:24:15 PM

Story below on MedScape

What's amazing is that I gave all this RICO and Lyme corruption data to
James
Phillips (a Yale shrink) who said it should be written up in the New
Yorker
Magazine,
and then said under oath that it all meant I was like Ted Kascynski.

This is from a Freudian, now. A man who has a *genuine* sex-obsession,
and so
he can "hear" nothing else. Psychiatrists are not aware that their
victims can
be watching *their* antics, too, so this is really an interesting story
which
will one
day soon be a book. You can actually make them jump-startle. That is,
if
they're
not literally not taking a nap on your dime. You can verify
independently about
the
Freudian stuff. These psychiatrists truly are stupid people. They're
all so
*stupid,*
it's scary. It amazes me that a man whose only topic is sex could
that much of
a
dickless coward.

Now of course we all know I am right about Yale's scientific fraud re
Lyme
disease
and LYMErix. Worse still, the DCF obstructed the RICO investigation
(stole Richard
Blumenthal's RICO mail, for instance), which is the exact opposite of
their job
requirement,
and none of them went to jail. Ever. The DCF is used against
whistleblowers
because
there is no trial, your phone is bugged, which means the "judge" knows
the phone
is bugged,
so the "judges" assume the DCF is telling the truth about what you said
on the
phone.
They most certainly do not. In a DCF trial, you are not allowed a
defense,
because of
the illegal spying and wiretapping. The judges assume the DCF is
telling the
truth.

You are not allowed to defend yourself at all. If you try, the DCF
will file
false criminal
charges, which they don't have to prove, since it's all *secret*
nonsense.

====================

"It was clear that I could not count on any federal agency or
politician to step
up to the plate."

This is very, very, true. No one does their job.

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Blowing the Whistle: A Pharmacist's Vexing Experience Unraveled

Jeffrey Fudin

Am J Health-Syst Pharm. 2006;63(22):2262-2265. ©2006 American
Society of
Health-System Pharmacists
Posted 01/03/2007
Introduction

On February 6, 2005, the New York Times reported that Paul Kornak pled
guilty to
fraud and criminally negligent homicide a month earlier.[1] Kornak was
a
nonphysician employee at the Stratton Veterans Affairs Medical Center
(SVAMC) in
Albany, New York. On November 21, 2005, a federal judge sentenced
Kornak to the
maximum prison term of six years. According to a local report, "At
least one
veteran died and 64 others suffered unduly or were harmed by the
forgeries,
which involved manipulating their medical backgrounds so they would
qualify to
participate in lucrative drug studies ...."[2] A decade earlier, two
pharmacists
had warned that patients were placed at risk or had died because of
similar
unethical experimentation.[2]

Currently, an elusive federal investigation purportedly continues to
determine
which Department of Veterans Affairs (VA) physicians and administrators
were an
integral part of the patient abuse conspiracy, the cover-ups, and the
retaliation against the two pharmacists who dared to expose the truth
for
greater than a decade; I am one of those pharmacists. I will share some
personal
experiences and lessons learned and review the professional guidelines
and moral
responsibilities that are explicit in the pharmacists' code of ethics.
I will
also share the strategies that enabled me to persevere, should pharmacy

colleagues face similar challenges to their professionalism and
integrity.
In the Beginning

It was in April 1993, after first following the usual chain of command,
that I
initially visited the chief of staff of SVAMC to orally report various
cancer
research violations. Some patients had been placed in research studies
without informed consent, and some were coerced into study
participation. Several patients did not meet study inclusion criteria
for
company-sponsored pivotal trials. Groups of patients received
chemotherapy
combinations of drugs with Food and Drug Administration-approved
labeling to
treat unsubstantiated tumor types while the study investigators
secretly
collected outcomes data. Certain data collection was subsequently
sanctioned by
the institutional review board (IRB). By November 12, 1994, I needed to
document
certain violations; within a month, I was the subject of an internal
investigation questioning my professional conduct.

As I climbed the chain of command to report my observations, it became
painfully
obvious that institution officials were angered by my "protected"
disclosures. I
felt obligated to bring my concerns to an outside agency, the VA Office
of
Inspector General (VAOIG). According to documents filed with VAOIG,
certain
cancer patients were being placed on physically incompatible drug
combinations. Outcomes data were selectively collected on
patients without an IRB-approved protocol. Several patients'
central-line
catheters clotted, requiring surgery for line replacements. After
putting these
concerns in writing, I was threatened. The exact words still ring
clearly in my
ears, "Fudin, I will bury you." I reported many other research
violations
involving multiple studies; however, the extent and complexity preclude

discussion herein.

In 1995, a new pattern of illicit research emerged using dangerous
dosing
patterns and combinations of drugs that were clearly unstudied for
certain tumor
types. In at least one case, there was an undisputable patient death,
and in
other cases, hastened deaths. As the Code of Ethics for Pharmacists
enjoins us
to tell the truth and to act with conviction of conscience, I wrote a
report of
my findings and sent copies to several administrative medical personnel
in March
1996. It included my refusal to participate or comply with any
physician orders to dispense these medications, at unstudied dosages in
unstudied
combinations, to patients. Within two days, I received a memorandum
charging me
with "patient abuse for failure to dispense medication as required by
the
oncologist." This prompted me to file complaints with VAOIG, the New
York State
Office of Professional Discipline (NYS-OPD), and the Office of Special
Counsel
(a federal agency supposedly in place to protect federal whistlebl
owers). NYS-OPD abrogated the complaint and sent it back to VAOIG,
since it was
deemed a federal matter. As the conspiracy unraveled, I learned that
VAOIG had
been working collaboratively with certain VA officials; this
collaboration, in
my opinion, served to avoid VA's accountability.

I disclosed several subsequent research violations to local, regional,
and
national VAOIGs. Although some cursory investigations commenced, it
became clear
that a conflict of interest existed, since VAOIG is a federal agency
and working
collaboratively with VA. As research funds continued to pour into
SVAMC, pressures to squelch my disclosures at a very high
administrative level seemed implausible but real. For instance, within
two days
of my reporting of another serious protocol violation that sent a
patient to the
medical intensive care unit resulting in the placement of a
thorocostomy tube, I
was investigated for "practicing outside [my] scope by requiring
certain blood
work prior to dispensing chemotherapy." Because of this conflict, I
felt it
necessary to report evidence to the Federal Bureau of Investigation
(FBI).
Unfortunately, FBI accepted VAOIG's request not to investigate, since I
was the
subject of an internal VAOIG investigation for practicing outside my
approved
scope
. In essence, FBI did not investigate even after I produced documented
evidence
of patient harm, abuse, and deaths; this suggested to me an
inappropriate
collaboration between VAOIG officials, FBI, and VA administrators.

SVAMC was, however, obligated to convene an internal investigation to
determine
the legitimacy of my allegations. The investigation was assigned to a
pulmonologist
named Thomas Ferro. Many of his findings were consistent with my
disclosures.[3]
But the chief of staff changed the report and ordered Dr. Ferro to sign
off on
certain edits and to destroy any original documents and computer files.
Dr.
Ferro admitted this to investigative reporters for a local newspaper
and the New
York Times.[1,3]

By July 1995, the chiefs of staff and the department of medicine had
approached
Anthony Mariano, SVAMC's pharmacy manager at that time. Mariano was
ordered to
counsel and place me on probation regarding certain alleged
"undesirable
professional activities." A man of high integrity, Mariano refused to
succumb to
administrative pressures even though this made him vulnerable to
retaliation.
For supporting me and for making his own "protected disclosures," his
desk was
moved to an empty psychiatric ward where he had no computer, no phone,
and no
job assignments.[4] He was eventually terminated for allegedly allowing
a clinical pharmacist to practice outside an approved clinical
scope, a charge that, upon subsequent investigation by several
agencies, was
dismissed. This cluster of retaliations came from a newly assigned
regional
pharmacy manager, a pharmacist, who Mariano and I believe was sent to
our region
by Washington, D.C., officials to remove us from government service.
Mariano wa
s forced to resign with no opportunity for a hearing. Just two weeks
after my
own termination, the regional pharmacy manager was whisked off to a
Washington-based job with a promotion, but in December 2001, I
prevailed in
court and was reinstated to SVAMC by a federal judge. The retaliation I

experienced is too comprehensive for this commentary; however, a
partial
chronological summary can be viewed online.[5]
A Balancing Act

Why did you stay, how did you survive, and would you do it again are
the
questions most often posed to me. Yes, I would do it again but the
chronology of
my survival strategies would have changed on the basis of my
experience. I believe some issues could have been resolved
sooner. I could not walk away from a situation I felt was evil to
health care
workers and patients who would otherwise have been left behind. Had I
left, it
would have appeared that I did something awful that could have
blemished my
integrity and the pharmacy profession, and the real perpetrators would
have
remained behind unscathed to torment more staff and to abuse more
patients. A
win for VA would be a huge loss for everything that seemed honorable.

This was a clear turning point in my career, because I needed to make a
decision
that would ultimately affect more than a decade of my life. Unbeknownst
to me,
it would be all encompassing, daunting, and expensive, and it would
take a
significant toll on my family. I needed to attempt to balance my
integrity and
responsibilities to patients, pharmacist colleagues and other medical
peers,
family, outside professional obligations, friends, and, perhaps most
importantly, the maintenance of my own sanity. As time passed, I began
to believe I was paranoid; however, I
was often reminded by my VA colleagues that paranoia is an unreasonable
fear;
the fears that I endured were quite real.

By 2005, I had contacted local Congressman Michael McNulty (NY), U.S.
Senator
Hillary Rodham Clinton (NY), the Democratic and Republican staff
directors of
the Sub-committee on Oversight and Investigation for VA, four VAOIG
offices, the
U.S. Office of Special Counsel, two U.S. attorneys, New York State's
Office of
Professional Discipline, and FBI.
Survival Strategies

Just before I was fired, a VA manager and long time friend said to me,
"Jeff, I
wish I didn't know some of the things I know. You should get out while
you can,
before they destroy your reputation."

Those days are long past. There comes a point when you need to run or
fight
back. I needed to create an environment where I was the predator
instead of the
prey, and I needed to make the message clear that anyone guilty could
potentially be exposed. The paranoia needed to shift if I were to
perservere. I learned that within
the federal government, there is a protective shield for "insiders"
known as
bureaucracy. Since similar sociology likely occurs within nonfederal
health care
institutions, I suspect that this discussion has wide-spread
applicability. I
knew if the bureaucratic barrier were pierced, it would cause chaos
among
certain corrupt administrators.

Before taking such a bold plunge, I needed all the necessary
documentation to
support my allegations in order to preserve my credibility and not
appear as a
disgruntled federal employee. I was and remain disappointed, but I was
not
disgruntled and not yet disenchanted. Clear documentation was
absolutely
essential, for if it were not documented, it did not happen. I can
offer this
advice: If you are going to court, get an attorney who knows the system
and
specializes in employment law, not health care law. Allow your friends
and
colleagues to help. If you work for a large institution, you have the
advantage. If you did the right thing, medical doctors, nurses,
pharmacists,
and other health care professionals will help you achieve your ultimate

goal-protecting the patient. It is similar to the American colonists
fighting
the redcoats-the settlers were more familiar with the inner workings of
the U.S.
territory, and they could easily ambush their adversaries. Without
realizing it,
I w
as considered a modern-day Paul Revere, a whistleblower. And so, the
struggle
began.

It was clear that I could not count on any federal agency or politician
to step
up to the plate. As a cautious returning SVAMC employee, I watched the
2002
Kornak story unfold in my local newspaper.[2] I knew in my heart that
although
he deserved punishment for his crimes, he had been used by the
government as a
convenient scapegoat to avoid accountability for more than a decade of
criminality predating his employment. I decided it was time to enjoy
the first
amendment right to freedom of speech. How appropriate it seemed that
the very patients I cared for were the ones that have preserved that
freedom. Several
newspaper articles began slowly exposing the patient and staff abuses,
first
piecemeal, then chronologically. Mariano and I were asked by local
veterans
groups to be co-Grand Marshals for the 2003 Albany Memorial Day Parade,
a rare
honor bestowed to nonmilitary men. Shortly after, the media attention
started to
snowball locally, nationally, and in professional journals and m
eetings. In late 2004, I was contacted by the New York Times; it was
interested
in publishing an exposé of the unfolding story since it had national
implications in time of war. This exposure, coupled with documents I
began
posting on my newest Web site,[6] made a lot of people nervous.

In April 2005, I contacted an FBI whistleblower, Sibel Edmonds, founder
of the
National Security Whistleblowers Coalition (NSWBC).[7] The comparisons
between
retaliation suffered by her coalition members were so similar to that
of VA
whistleblowers, one would think that there was a policy manual on how
to harass federal whistleblowers. I learned that
similar to VA whistleblowers, our NSWBC counterparts all attempted to
address
corruption from within their agencies before going public. All were
honest
employees who risked their careers to do the right thing; they were
heroes, not
troublemakers. We agreed that it would be beneficial to start a partner
group,
the VA Whistleblowers Coalition, to assist targeted VA
practitioners.[8]
Although it was a time-consuming task, I well understood that to go it
alone is
a stressful undertaking-my health care colleagues could benefit from
the
experiences and support of others. The power of the Internet came
alive.
Reality, Practicality, and Morality

Investigations of unauthorized experimentation, malfeasance in health
care
provision, and medical corruption are difficult and expensive to
investigate.
FBI and other federal agencies tasked with investigative
responsibilities seem
unprepared for investigations of VA and remain reluctant to start
investigations. These agencies may be reluctant to investigate, perhaps
out
of fear of what may be found, perhaps because of reticence to attack
another
government agency, or perhaps because the victims of these crimes are
poor and
sick and have few resources. I believe the government needs to be
prompted to
develop an investigative protocol using a nonfederal organization with
no
conflicts of interest or incentives. The government must remember that
the
people who are being harmed at VA are those who have risked their lives
to keep
this country free.

Administrators and licensed professionals who spent a decade
retaliating against
employees attempting to bring the abuses of Kornak and others to light
should be
held accountable for their actions. These people are far more dangerous
than a
dozen Kornaks, since they have taken up various posts across the
country and
threaten to undermine accountability at a number of VA institutions.

Finally, we all need to be reminded of our promises endorsed by the
American Society of Health-System Pharmacists. "A pharmacist has a duty
to tell
the truth and act with conviction of conscience. A pharmacist avoids
discriminatory practices, behavior or work conditions that impair
professional
judgment, and actions that compromise dedication to the best interests
of
patients .... The primary obligation of a pharmacist is to individual
patients.
However, the obligations of a pharmacist may at times extend beyond the

individual to the community and society. In these situations, the
pharmacist
recognizes the responsibilities that accompany these obligations and
acts
accordingly."[9] This commentary provided a brief chronology of patient
care
violations. To report such violations is a duty required by the
pharmacy
profession's codes of conduct; the method by which one makes these
disclosures
is optional.

I treasure my job and feel honored and fortunate to serve veterans.
Although
some may judge this history as seditious, I wish to clarify that my
allegiance
to U.S. veterans and the pharmacy profession will always trump
bureaucracy. Unlike my adversaries,
I did not specifically set out to destroy any single person's
reputation and
certainly not the VA as a whole. But I made it very clear to the world
that
pharmacists are masters of documentation and are respectable
professionals who
take their oath of patient advocacy seriously.
References

1. Sontag D. In harms way. Abuses endangered veterans in cancer drug

experiments. N Y Times. 2005; Feb 6:A1, B28.
2. Lyons B. Apologies and excuses at VA case sentencing.
http://www.vawhistleblower.com/11-22-05%%20Apologies%%20and%%20excuses.pdf

(accessed 2006 Sep 14).
3. Lyons B. Cover-up charged in VA probe.
http://www.vawhistleblower.com/2003-05-26-TU-Charged.pdf (accessed 2006
Sep 14).
4. Memorial Day media clip.
http://www.vawhistleblower.com/memorialday%%20media%%20clip.avi (accessed
2006 Sep
14).
5.
http://www.vawhistleblower.com/12-20-05%%20Collective%%20Retaliation.rtf.

(accessed 2006 Sep 14).
6. VAWhistleblower.com. http://www.vawhistleblower.com" (accessed
2006 Mar 21).
7. National Security Whistleblowers Coalition. http://www.nswbc.org
(accessed
2006 Sep 14).
8. Veterans Affairs Whistleblowers Coalition. http://www.vawbc.com
(accessed
2006 Mar 21).
9. Code of ethics for pharmacists.
http://www.ashp.org/bestpractices/ethics/Ethics_End_Code.pdf (accessed
2006 Sep
14).

Reprint Address

Dr. Fudin, P.O. Box 175, Delmar, NY 12054. Email: fudinj@gmail.com

Jeffrey Fudin, Pharm.D., B.S., DAAPM, is Clinical Pharmacy Specialist,
Stratton
Veterans Affairs Medical Center, Albany, NY; and Adjunct Associate
Professor of
Pharmacy Practice, Albany College of Pharmacy, Albany, NY.

--
http://www.actionlyme.org

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