Whistleblowers  Prevnar (pneumococcal)  Contaminants

Wyeth whistleblower Mark Livingston describes problems at Prevnar vaccine plant

Mark Livingston is a former employee of Wyeth, turned
whistleblower after complaints of manufacturing problems
with Prevnar vaccine were not addressed by management. Below
is the speech he gave at a December 20 ceremony, at which he
was given the Joe A. Callaway Award for Civic Courage.

Livingston asks that this speech be forwarded to as many
people as possible. Hopefully public pressure will demand
accountability and result in improved vaccine manufacturing
quality. - NEH

Ladies and gentlemen, thank you for being here tonight. I
believe we are here to recognize not only Dr. Graham and
myself, but all individuals who summon the faith and courage

to challenge unethical and unlawful practices.

I want to share with you the story regarding my attempt to
change the dysfunctional regulatory compliance culture of a
pharmaceutical manufacturing plant in the years 2000-2002.

- I was hired in 2000 by Wyeth Pharmaceuticals to help in
the introduction of Prevnar, a new vaccine designed to fight

pneumoccocal pneumonia and meningitis in babies. The North
Carolina facility where I worked is the sole production site

for this pediatric vaccine which is taken in a four-dose
regimen by every infant in the United States at 2, 4, 6, and

12 months. One of my key responsibilities was to assure
compliant manufacturing through quality training and
continuous improvement systems.

- Within weeks of hire, I was approached by numerous
employees with regulatory compliance and safety concerns.
My own investigation revealed chronic under-staffing at this

24x7 operation as well as shortcuts within basic quality
control and training processes.

- As Wyeth attempted to meet the rapidly growing demand for
Prevnar and to meet mandates of a FDA consent decree for
quality control violations, large numbers of new employees
with limited backgrounds in vaccine production were being
hired. Because of the complex nature of biological vaccine
manufacturing, basic training for front-line employees took
12 months.

- At the same time, repeated quality audits in 2000, 2001,
and 2002 revealed noncompliance with corporate and FDA
regulatory standards.

- In mid-2002, I wrote a letter to Wyeth management refusing

to misrepresent the compliance status of the site in an
upcoming consent-decree audit whose results were to be
forward to the FDA.

- After being directed by management to not discuss or
provide information regarding noncompliance, I filed
complaints with ethics and compliance officers of the
company, alleging gross noncompliance and release of product

in violation of FDA regulations.

- Two months after my internal whistleblowing, I faced
disciplinary action with a threat of termination for 10
alleged performance deficiencies, one of which included a
"gag order" to not discuss compliance deficiencies with
internal or external contacts (which I interpreted to mean
the FDA).

- Two months after this retaliation, I was terminated for
alleged "professional misconduct" by the same two company
officials who delivered the gag order.

In reality, I was terminated for my efforts to address and
rectify quality compliance failures leading to the
adulterated release of vaccine in violation of both FDA
consent decree mandates and SEC regulations regarding
disclosure. With help from the Government Accountability
Project, I brought suit against Wyeth in federal district
court for retaliatory discharge in violation of
whistleblower protection provisions of the 2002
Sarbanes-Oxley Act.

Throughout my 21-year career as an organization development,

human resource, training, and quality improvement
professional, I have helped talented and progressive leaders

learn how to change their organizational cultures to
continuously improve workplace performance. I have spent a
considerable amount of time and effort teaching and coaching

people to use diagnostic tools to discover the root causes
of problems and take action to prevent recurrence of
systemic failures and breakdowns. As a result, I've
developed expertise in redesigning and implementing
operating and quality systems that engage workforces to
deliver intended compliance and financial outcomes.

Organization or workplace culture is defined as the shared
attitudes and perceptions within an organization. It is made

up of the values and behaviors that formally and informally
influence how employees think about themselves, their
colleagues, their leadership, and their work. The "way we do

things around here" gives people a common identity, builds
commitment to achieve important objectives, and shapes human

performance. Considerable research in the last ten years has

verified the relationship between an organization's culture
and its operating results and financial performance.

The valuable lessons I've learned from successful as well as

failed efforts to change culture and improve performance
include these:

1. Successful leaders proactively become aware of what's
really taking place on the front-line of their organization.

2. Successful leaders quickly move through the typical
responses of denial and resistance.

3. Successful leaders move past personal fear and confront
unacceptable situations, including intimidating forces of
resistance assembled against them.

In fighting the battle between greed, financial security,
and personal integrity, successful and ethical leaders
absolutely know the "right choice" to make and the "right
thing" to do.

I've also learned that the most successful of leaders and
work cultures are not afraid of bad news, they do not shoot
messengers of bad news, nor do they seek to blame or
ostracize people with dissenting points of view. They don't
spend precious time and resources in complaining, whining,
and looking for legalistic justifications to rationalize

Within FDA regulated facilities, a work culture - whether
high performing or dysfunctional - has a significant impact
on the attitudes and performance of front-line employees.
This is especially true when it comes to compliance with
safety regulations that have an impact on product quality.

cGMPs - or current Good Manufacturing Practices - are the
bedrock of regulatory requirements designed to assure the
safety, integrity, sterility, quality, and purity of
pharmaceutical or biological vaccine products. When you read

about GMP issues at the Chiron flu vaccine facility or hear
about FDA consent decrees at Wyeth and Schering-Plough for
GMP manufacturing violations - think safety, integrity,
sterility, quality, and purity - or simply, SISQP.

In the complex world of biological vaccine manufacturing,
anything that has a direct impact on SISQP must come under
documented and/or validated quality control protocols and
procedures. These quality requirements are audited by the
company and at times by third-party consultants, as well as
by CBER, the FDA's Center for Biological Evaluation and
Research. These inspection audits take place every two years

to ensure compliance with GMP requirements.

Do not believe Wyeth or any pharmaceutical or biotechnology
company if they tell you the Code of Federal Regulations and

quality system procedures are mere guidelines or
expectations with no legal or financial consequences. Or
that effective dates which drive quality system operations
are simply internal moving targets. Recent fines levied by
the FDA for violation of GMPs destroy this wishful thinking.

Reference the $30 million fine paid by Wyeth, the $100
million fine of Eli Lilly, the $229 million in fines of
Abbott Labs, and the $500 million fine paid by
Schering-Plough in four easy installments.

In fact, the FDA is atypically and unusually clear in this
area. Quote: "There is a public health significance to cGMP
noncompliance. A manufacturer who fails to comply with cGMP
requirements is less likely to produce a product that
performs as intended."

I'm sure you can appreciate the alignment created by the FDA

and the SEC between noncompliance and the disclosure of
production, sales, and financial information which
securities analysts and shareholders use to make investment

Nor should you believe the pharmaceutical company or trade
association spokesperson who claims there is no connection
between operating, product safety, and compliance results in

a regulated industry and the financial information disclosed

to shareholders. In fact, they are "heads" and "tails" of
the same coin

Finally, do not believe the Wyeth representative who claims
there is no significant impact on the safety and health of
newborn infants for violating regulatory requirements that
drive product safety and manufacturing integrity.

As over 1 million doses of the pediatric vaccine Prevnar are

distributed and administered each month in the United States

alone, even odds of 1 million to 1 that anything significant

could happen with a batch of vaccine means that 1 child each

month could be harmed by this brew of chemicals - which is
manufactured, by the way, with one of the most toxic
substances known to human beings.

Changing the organizational culture at this North Carolina
manufacturing facility was extremely difficult and painful,
despite the presence of a consent decree and permanent
injunction that prohibited Wyeth from releasing adulterated
product into interstate commerce. Pharmaceutical drug or
biological vaccine products are considered adulterated if
they are manufactured in violation of current Good
Manufacturing Practices.

Product adulteration - if willful and intentional -
constitutes fraud. As the Associate Director of Training and

Continuous Improvement at the site, I personally led two
courses which covered basic ethical and compliance
requirements. In addition, a comprehensive GMP curriculum
was in place that specifically addressed adulteration and
both the legal obligation and liability each manager and
supervisor had for ensuring compliance.

So what happened? Why did it take over two years of internal

struggle and conflict to achieve integration of core quality

systems and put basic GMP compliance requirements into
place? Why did the internal investigation, when finally
conducted in August 2002, fail to meet standards established

by both Wyeth and the FDA for just these noncompliant

How did a $14 Billion multinational corporation - with
plenty of smart people tripping over each other - manage to
screw it up? And why was no one in the financial community
or at the FDA told about or aware of these GMP compliance
failures in 2002? We heard Wyeth executives provide
contradictory and confusing disclosures about GMP
manufacturing and Prevnar quality problems in November 2003.

Why the silence in 2000, 2001, and 2002?

Was it the fear of monetary fines to the tune of $15,000 per

day for missing FDA consent decree commitment dates? After
all, Wyeth had already paid out $1.2 million in fines for
missing deadlines in 2002.

Was it the fear of not being able to ship 200 batches of
backlogged Prevnar, worth $200+ million in sales? After all,

shipments of Prevnar were down 40% in mid-2002 and the 4th
dose of this pediatric vaccine was yet again on curtailment.

Was it the fear of continuing a backlog of Prevnar orders
and not being able to book and report revenue that commands
a 95% gross profit margin?

Was it the fear of disclosing negative information about GMP

non-compliance to the FDA or Centers for Disease Control?
After all, the Vaccines for Children Program which purchased

approximately $851 million dollars of Prevnar through
taxpayer and Medicaid dollars in the years 2000-2002
required Wyeth to manufacture Prevnar in accordance with

Was it the fear of having to disclose negative information
to shareholders and consumers coming on the heels of
publicity in July 2002 that Wyeth's hormone replacement
therapies weren't all they were marketed to be? After all,
the stock price only crashed $20 dollars per share wiping
out $24 billion in market value in a matter of weeks.

Or was it the fear that after manipulating a gullible and
inattentive FDA about safety and compliance, investors,
consumers, and government oversight committees would see
that Wyeth had rushed Prevnar - or had been allowed to rush
Prevnar - to market without adequate manufacturing
capability and regulatory controls?

I'm afraid we may never know the answer to why Prevnar was
introduced in February 2000 in a facility - supposedly
inspected and approved by the FDA - that was not GMP
compliant. Or why it took another 2 years for basic
quality systems and quality control processes to be enforced

despite the FDA consent decree. Or why senior officials at
CBER during a July 2003 meeting at FDA headquarters never
responded to my concerns, allegations, or documentation.

In thinking about my experience at Wyeth and the legal
battle to hold key decision makers accountable for their
lack of courage in disclosing unlawful and improper
compliance and business practices, I often ask myself: How
could well-intentioned, intelligent people make such poor
decisions related to a chemical-based product that is
injected into innocent babies.

 Is it greed? Is it fear? Is there an ethics gene that
undergoes mutation in the heat of running large and complex
organizations? What would possess a person or a group of
decision makers with great influence to flunk such a basic
test of ethics, business law, and social responsibility?

I wonder if the answer might lie in a simple, elegant
question posed by a concerned manufacturing technician in
October 2000 at this North Carolina facility.

In front of a group of some 40-50 employees, this technician

asked me a question that I still remember to this day: "Mr.
Livingston, are we here to make money or to save lives?"
Without hesitation, I told her that we were here to save
lives! I felt proud of my A+ response.

Then I blew it! The rational, left-side of my brain kicked
into overdrive and I started to worry how the corporation or

my boss would react to my answer. After all, we're a
profit-making, free-enterprise, capitalistically-driven
company that seeks to serve shareholders and recapture our
R&D investment - right?

So I added, "But we also need to make money in order to
continue making the product that saves lives."  I did not
feel proud of my new grade, a revised C-.  Thank God the
person was "North Carolina polite" and asked no more

Upon reflection, I realized this technician was testing me
and that I had failed to answer two important questions:

1. What is the real purpose and mission for our work?
2. How do I make a decision when it comes to safety vs.

I would suggest that many of the recent problems in the
pharmaceutical industry or at the FDA - indeed within our
corporate and government institutions in general - have
germinated and grown as a result of confusion and conflict
over the answers to these two questions. Perhaps this is
where we need to start in order to re-establish trust and
credibility - that is, to revisit "mission" and "purpose."

Is it new drug approval or product safety? Is it treating
the industry as a partner and client or is it enforcing
regulations that protect consumers and patients? Is it
having the courage to disclose bad news to shareholders or
is it a desire to mislead investors and consumers with
deceptive business and compliance practices?

In the stress of an ethical dilemma worth hundreds of
millions of dollars, we must be absolutely clear on what is
the correct answer. No hesitation, no waffling, no
multiple-choice answers.

Courage has been defined as the state or quality of mind or
spirit that enables one to face danger, fear, or the
vicissitudes of life with self-possession, confidence,
bravery, and resolve. Courage implies firmness of mind and
will in the face of danger or extreme difficulty.

To this day, I continue to thank that manufacturing
technician for teaching me - and us - a valuable lesson by
asking the courageous question: are we here to make money or

save lives?

I would like to thank the Shafeek Nader Trust for the
Community Interest for this prestigious award. I sincerely
appreciate the recognition - Ms. Nader - that you and
directors of the Trust have provided.

Thank you.and thank you ladies and gentlemen.

For additional information, contact:

Mark Livingston
3905 Ketch Point Drive
Rocky Mount, NC   27803
252-451-0367; careerps@earthlink.net

Joanne Royce
Government Accountability Project
1612 K Street NW, Suite 1100
Washington, D.C.  20006
202-408-0034; joanner@whistleblower.org


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