Parents that don’t vaccinate

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From Dr. Moskowitz’s previous article in Pathways (issue 10), we learned that the theoretical effect of vaccines on the infectious diseases they are designed to protect against is misleading at best.

He also illuminated the potential long-term consequences of vaccines on an individual’s overall health and wellness. I would like to present what is known about the body’s immunologic response when exposed to a microorganism naturally as compared to the response generated by the conventional vaccines. Questions that this discussion will raise are:

 

Can the immune responses generated by the vaccines create a pattern of immune imbalance that actually compromises the child’s immune system?

Does the resulting pattern of immune imbalance promote imbalances in other body systems resulting in chronic health issues?

What is known about reversing the imbalance generated by vaccines and/or other immune stressors?

 

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We have known for decades that getting the childhood diseases naturally results in a permanent immunity to the specific microorganism. Getting the vaccines results in a temporary immunity, meaning that susceptibility is deferred and repeated booster shots will be required for the ENTIRE life of the individual. In the 80s, the specific immune mechanisms involved in vaccine-induced immunity was discerned. In the 90s, the same mechanisms in humans were explored. T cells (thymus cells) are the major cell in the immune system; they direct and control all immune responses as well as immune memory. Subsets of T cells are the T-helper cells (Th). T-helper cells coordinate and direct the safest and most effective immune response. Using Moskowitz’s measles example, we know that, when infected with the measles virus naturally via the nasopharyngeal route, the body produces a Th1 response that externalizes the infection and provides permanent immunity.1 Fever, rash, coughing, sneezing, etc are signs of the body ridding itself of this infection. Bypassing the normal body lines of defense by injecting a vaccine forces the immune system into an emergency-based Th2 response which serves to internalize the infection. You don’t get the disease but are susceptible to the disease later since the Th2 response results in poor immune memory. So, if a natural, viral (measles) infection results in a Th1 response, why don’t we make vaccines that could elicit the same response.

In 1995, Golding and Scott,2 published the need for strategies to make vaccines that would generate the “required” Th cell to the corresponding microorganism. Since that time, attempts to produce vaccines that would generate a “natural”- type response have failed. So, we are left with vaccines that generate “protective” responses as a second choice. How does this work? In vaccine-induced Th2 responses, called humoral responses, the body produces large quantities of specific antibodies that block the virus from entering cells. This response is why a vaccinated child doesn’t get a full blown infection and why the child won’t spread as many viruses into the environment. However, antibodies cannot get into cells to eliminate viruses once the viruses are in the cells or cannot kill infected cells themselves. Therefore, the body has no choice other than to internalize the virus and be chronically infected when the body is forced into a Th2 antibody response. The body is essentially constipated with viruses that it cannot expel!

Unvaccinated children who are exposed to measles will generate the immune response that is required to make permanent immunity as well as kick out the virus from the body. The normal, healthy body’s response to viruses is to externalize them. To suppress this natural response can be as hazardous to our health as suppressing waste elimination from the bowel or toxin release from the skin. Natural Th1 responses generate cell-mediated responses that serve to both neutralize viruses by producing antibodies and most importantly stimulate the immune cells necessary to kill any cells infected with viruses. The body works to externalize and eliminate viruses when the Th1 response is generated. So we understand now that when a Th2 response is induced, “it drives the infection deeper into the interior and causes us to harbor it chronically.”3 It is commonly held that the presence of antibody to viruses is a sign of a chronic on-going infection not a sign of immunity.4 Our bodies generally need to have Th1 cells to defend against viral, Gram-negative bacterial, and fungal infections, and tuberculosis, as well as to protect against cancer. Th2 response is necessary to protect against Gram-positive bacterial, parasitic infections, as well as to neutralize toxins from microorganisms and the environment. A balance of Th1/Th2 cells in the body is defined as immunostasis (or immune balance) and is required for optimum health and wellness. Vaccines promote a failure in immunostasis by making the Th2-type cells dominant.

Can the immune responses generated by the vaccines create a pattern of immune imbalance that actually compromises the child’s immune system?

We saw how a vaccine-generated Th2 response can burden the body and exhaust the immune system by forcing the body to deal with a chronic ongoing infection. A Th2 response to a specific virus infection will specifically suppress Th1 cells from becoming activated against the same virus. With the resulting failure to generate a Th1 response, cells infected with virus cannot be destroyed. Chronically infected cells, like nerve cells, can occasionally trick the immune system into reacting to and attacking similar nerve cells resulting in autoimmune disease such as multiple sclerosis, Guillain Barré, etc. Cells chronically infected with live vaccine viruses also risk having the viruses mutate, trade genes with each other, as well as interact with the host cell DNA.5 The live vaccines used presently include, measles, mumps, rubella, varicella (chickenpox), and flu-mist. Overactive Th2 activity, underactive Th1 capability, chronic infection, potential for novel virus infection and autoimmunity characterize failed immunostasis or Th-cell imbalance in vaccinated children.

The classic work by Ader & Cohen,6 taught us that the immune system can be classically conditioned. Like Pavlov training dogs to salivate at only a ringing bell, the immune system can be conditioned into inappropriate responses through repeated vaccinations. Natural exposure to the environment and infectious diseases conditions immune responses to be more Th1 dominant; whereas repeated vaccine exposure conditions responses to be more Th2 dominant. A child with Th2-dominance is more susceptible to intracellular organisms such as viruses and is therefore more prone to chronic ear, respiratory, and gastrointestinal infections. Children need a vibrant Th1 response to appropriately deal with the childhood intracellular viral infections, whooping cough, and hemophilus. Healthy immune systems are said to be in Th1/Th2 balance or “immunostasis.” Unhealthy immune systems are said to have a failure in or an imbalance in “immunostasis.” Parris Kidd,7 has compiled a fascinating review indicating that there may be a link between Th1/Th2 balance and disease. Diseases such as allergies, asthma, atopic dermatitis, systemic lupus erythematosus, cancer, tuberculosis, and AIDS, appear to result from a Th2-dominant immune response. It is imperative that we discern the impact of conditioning children’s immune responses to be more Th2 dominant and the consequences of this pattern on the incidence of the Th2-dominant diseases listed by Parris Kidd. When we become Th2 dominant, the antibody-producing part of our immune systems gets derailed like a freight train going a hundred miles per hour, out of control. E. Hurwitz et al has shown that unvaccinated children have less incidence of respiratory conditions, such as asthma and allergies, when compared to their vaccinated counterparts,8 thereby supporting Kidd’s hypothesis.

The focus of much current research is the role of inflammatory responses of varying degrees of severity serving as precursors to cancer, cardiovascular disease, and chronic degenerative diseases being influenced by the different Th cells. Th2 immune responses direct and support bad, excessive inflammation whereas Th1 cells promote healthier type inflammation.

With evidence to support the adverse effects on the immune system by the vaccines, then why do we continue to vaccinate? The role of public health office is to reduce the incidence of infectious disease in the pediatric population. Vaccines generate protective immune responses on a temporary basis and reduce the incidence of infectious disease in the vaccinated kids as well as the unvaccinated kids. Why are the unvaccinated kids protected too? The risk of exposure to the disease is lessened when more individuals are vaccinated. As described, that happens because vaccinated children have tons of antibodies which neutralize infectious virus thereby lessening their ability to spread viruses to others. The phenomenon of unvaccinated children being protected by the vaccinated is known as herd immunity. Herd immunity is a welcomed effect of the vaccination process from a public health perspective. But, according to physicians like James Taylor,9 this may not be a good thing. Unvaccinated children progress into their adult years with a diminished chance of exposure to childhood diseases.

With the passage of time and the vaccinated population not getting their boosters, all become susceptible to the disease. Susceptibility to childhood diseases when we are adults greatly increases severe morbidity and mortality from those diseases. Parents and the powers that-be desire this vaccination approach in order to defer infectious disease to a later date so they do not have to stay home, miss work, and care for a sick child. Th2 dominance from vaccinations results in children being at risk of diseases arising from chronic ongoing infections as well as being vulnerable to the damaging effects of the infectious disease they were vaccinated against when they age and forget about getting booster vaccinations. On the other hand, there are parents anxious to expose their children to the childhood diseases through measles and chickenpox parties so a natural (Th1) immunity can be established early, provide lifelong immunity and appropriately condition the immune system to the natural environment.

 

Does the resulting pattern of immune imbalance promote imbalances in other body systems resulting in chronic health issues?

The 80s and 90s also brought us an explosion of research describing the various chemicals released by cells, especially the Th cells and the receptors on cell membranes capable of reacting to these chemicals. The chemicals (cytokines, interleukins) released by T cells act as signals interacting with satellite dish like receptors on all cell membranes, especially the cells of the nervous system. Similarly, chemical communication signals from the nervous system (neurotransmitters, neurohormones) can react with T-cell satellite dishes. T-cell chemicals can react and effect the entire brain.10 The concept that science now employs is psychoneuroimmunology. So, what you think can affect your nervous and immune systems as well as the immune and nervous system affecting how you think. So, when the immune system is out of balance and depressed, it sends out interleukins which react with the brain, generating depressed behavior, depressed moods and depressed thinking.11 This depression theme excites the sympathetic (flight or fight) nervous system and the cycle keeps on streaming out of control. Patterns of immune imbalance as seen with a Th2 vaccine-conditioned immune responses beget patterns of abnormal neurological and psychological patterns which can then affect all other body systems. Patterns of subluxation have been shown to result from and enhance sympathetic activity. Therefore, patterns of immune imbalance can generate subluxation and vice versa. Other factors that condition as well as support a Th2-dominant immune pattern and should be avoided are negative consciousness patterns, which generate stress, and antibiotics, which delete the normal Gram-negative bacteria and suppress Th1 cells, sugar, caffeine, trans-fatty acids, progesterone, antibiotics, mercury, oxidative damage etc.7

What is known about reversing the imbalance generated by vaccines and/or other immune stressors?

We know that a fetus thrives in a progesterone-rich maternal environment that is Th1 suppressive. But nature solves this by first exposing the baby to normal, probiotic bacteria while coming through the birth canal. These friendly Gram-negative bacteria from the mother stimulate Th1 activity in the neonate. Secondly, breastmilk contains the normal probiotic bacteria as well as the prebiotic chemicals that selectively supports the growth of the good bacteria and Th1 activity and discourages the growth of the bad fermenting-type bacteria. Colostrum and breast milk are also rich in the interleukins necessary to stimulate Th1 activity. It is understandable from this knowledge that breastfeeding is recommended for at least one year. Lastly, exposure to environmental viruses, other Gram-negative bacteria, and fungi will also stimulate neonatal Th1 activity. It is apparent that newborns who are delivered by C-section, not breastfed, and receive their baby shots have a remarkable squashing of their Th1 capability. Repeated vaccinations, poor nutrition, and nerve interference from subluxations, serve to support this failure in immunostasis. Things to do to reinforce Th1 activity and assist in reversing the immune imbalance generated by vaccines, C-sections, formula-only feeding, and other immunostasis disrupters, include developing positive, affirming consciousness behavior patterns and choices individually as well as within the family unit. Antioxidants, mushroom extracts, melatonin, dehydroepiandrosterone (DHEA), probiotic bacteria such as Lactobacillus acidophilus and GG, phytosterols and sterolins, and omega-3-fatty acids (fish oils) are just a few things that have been shown to increase Th1 levels. Chiropractic adjustments are also recommended to reduce the sympathetic nervous system influence on Th1 suppression. The summary table will review the roles of the Th1 and Th2 responses as well as list what is known to increase their respective levels.

Concerns for the future well being of our children should include yearly evaluations of their immune balance either through direct T-cell assessment or indirect analyses through cytokine evaluation. If children must submit to the current vaccine schedule12, their immune systems need to be evaluated for T-cell imbalances and all steps necessary employed to restore immune balance prior to the onset of chronic health issues. On the vaccine strategy end, it appears that the future focuses on the “dream vaccine.” This vaccine will consist of a large viral DNA strand containing spliced genes from all the microorganisms desired for vaccination. The genetically engineered DNA will be injected into the baby and then be integrated into the child’s cells. Once inside the cell, the vaccine DNA will be treated like the cell’s own DNA allowing the host cell to produce vaccine components over a prolonged period. So, the child’s cells will serve as their own vaccine manufacturing plant supplying the body with continuous booster stimulation for the immune system. Such implantation technology has already been implemented with the use of the Norplant device designed to release birth control medication over a 3 to 5-year period. Will the vaccine device generate the appropriate Th response? I cannot see how it can, but the real issue, from the public health standpoint, is not whether the appropriate Th response is generated but is a protective, antibody-generating response stimulated. So, we will end up where we began with regard to having vaccines generate Th2 responses only to replace that strategy with an implanted device that will condition the immune response the same way. The prospect of having our children implanted with a DNA-based vaccine device that promote an immune conditioning outcome over years is harrowing. Maintaining immunostasis as a result of this vaccine strategy will be a challenging struggle for years to come.

References:

  1. Abbas AK, Murphy KM, Sher A.  Functional Diversity of Helper T Lymphocytes.  Nature: 1996: 383  pp.787-793
  1. Golding S., Scott DE.,  Vaccine Strategy: Targeting Helper T Cell Responses.  Ann. NY Acad. Sci. 754:126-137,  May 31, 1995
  1. Moskowitz R., How Do Vaccines Work?  Pathways, Is. 10: 5-9, 2006
  1. Taylor,J.  Which Arm of the Immune Response most Likely Plays the Predominant Role in Host  Defense Against Influenza Virus: humoral or cell-mediated?  Medscape Feature, 1998, 08.98, p.443
  1. Urnovitz H.,  Archiving of Live Viral Vaccines.  From Proceedings of the First International Public Conference on Vaccination.  September 13-15, 1997.
  1. Ader R., Felten D., Cohen N.,  Psychoneuroimmunology.  Academic Press, 2nd edition, 1991.
  1. Kidd P., Th1/Th2 Balance: The Hypothesis, its Limitations, and Implications for Health and Disease. Alt. Med. Review, Vol.8 #3, 2003, p223-246.
  1. Hurwitz E., Morgenstern H. Effects of Diphtheria-Tetanus-Pertussis or Tetanus Vaccination on Allergies andAllergy Related Respiratory Symptoms Among Childern and Adolescents in the U.S.  JMPT Vol. 23#2 Feb. 2000
  1. Taylor, J .  Herd Immunity: The Varicella Vaccine Is it a Good Thing?  Archives Peds. Vol 155#4 Apr. 2001.
  1. Pert C.  Molecules of Emotion.   Touchstone, 1997.
  1. Watkins A. Mind Body Medicine  – A Clinicians Guide to  Psychoneuroimmunology. Churchill Livingstone, 1997.

A former vaccine industry employee turns whistleblower

A former vaccine industry employee turns whistleblower

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 24×7 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
misconduct.

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 decisions.

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 non-compliant situations? 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 GMPs.

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 ½ 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 questions.

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.
profit?

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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