Almost half of the flu vaccine required by the people of the United States
will not be delivered this year. Chiron, a
major manufacturer of flu vaccine, will not be distributing any influenza
vaccine this flu season. Chiron was to make 46-48 million doses of vaccine for
the United States.
On October 5, Chiron announced that the UK regulatory body, the Medicines and
Healthcare Products Regulatory Agency (MHRA),
had temporarily
suspended the company's license to manufacture
Fluvirin influenza virus vaccine in its Liverpool facility, preventing the
company from releasing any of the product during the 2004-2005 influenza season.
The suspension was imposed as a result of Chiron's failure to comply with the
requirements of Good Manufacturing Practice, leading to concerns of possible
microbial contamination of product.
Because of the vaccine shortage, the Center for Disease Control (CDC) is
changing its guidance about who should get vaccinated this season.
Why it Matters
Influenza is a serious disease, and people of any age can get it. In an
average year, the flu causes 36,000 deaths (mostly among those aged 65 years or
older) and more than
200,000 hospitalizations in the United States. The "flu season" in the
United States is usually from November through April each year. During this
time, flu viruses are circulating in the population. An annual flu vaccine
(either the flu shot or the nasal-spray flu vaccine) is the best way to reduce
the chances that you will get the flu.
The flu vaccine is the most effective way to prevent the flu. However, in
limited studies, the flu
shot and the nasal-spray flu vaccine (LAIV)
have different rates of effectiveness.
Flu viruses change from year to year, which means two things. First, you can
get the flu more than once during your lifetime. The immunity (natural
protection that develops against a disease after a person has had that disease)
that is built up from having the flu caused by one virus strain doesn't always
provide protection when a new strain is circulating. Second, a vaccine made
against flu viruses circulating last year may not protect against the newer
viruses. That is why the influenza vaccine is updated to include current viruses
every year.
Another reason to get flu vaccine every year is that after you get
vaccinated, your immunity to the disease declines over time and may be too low
to provide protection after one year.
Epidemics of influenza typically occur during the winter months in temperate
regions and have been responsible for an average of approximately 36,000
deaths/year in the United States during 1990--1999. Influenza viruses also can
cause pandemics, during which rates of illness and death from influenza-related
complications can increase worldwide. Influenza viruses cause disease among all
age groups. Rates of infection are highest among children, but rates of serious
illness and death are highest among persons aged >65 years and persons of
any age who have medical conditions that place them at increased risk for
complications from influenza. (from the
CDC Report on
Prevention and Control of Influenza )
The CDC has prepared a
pandemic preparedness
plan, in case the flu is more virulent or widespread than usual. A pandemic
– or global epidemic – occurs when there is a major change in the influenza
virus so that most or all of the world’s population has never been exposed
previously and is thus vulnerable to the virus. Three pandemics occurred during
the 20th century, the most severe of which, in 1918, caused over 500,000 U.S.
deaths and more than 20 million deaths worldwide.
On August 26, 2004 Chiron vaccines announced that in conducting final release
procedures for their Fluvirin influenza virus vaccine, their quality systems
identified a small number of lots that did not meet product sterility
specifications. This related to contamination with a nasty bacteria called Serratia marcescens. Chiron therefore announced that they had delayed releasing
any Fluvirin doses until completing additional quality assurance tests, a
process that was projected to delay release until early October. Recognizing the
public health implications of this projected delay, Chiron began
communicating with and informing public health stakeholders, agencies and
regulatory authorities, including the Centers for
Disease Control and Prevention, the
National Vaccine Program Office, the National
Institutes for Health, the
Centers for Biologics Evaluation and Research, and the UK Department of
Health. Chiron provided updates on the status of their investigations
to the public health stakeholders via weekly teleconferences and informal
discussions.
On August 27, 2004 Dr. Julie L.
Gerberding
and her staff from the
CDC held a
press conference to brief the press regarding the flu vaccine supply. In
that press conference she stated "What we expect at this point in time is that
actually we'll end up having more vaccine doses than we ever have had before".
She also went on to say "People who are 50 years of age and older should
definitely receive the flu vaccine". See Michael Fumento's article
The Feds' Flu Shot Fiasco
for more perspective.
None-the-less, Lester
Crawford, acting as the FDA commissioner,
said the agency had no hint of escalating concerns at Chiron's Liverpool,
England, plant before British authorities suspended the plant's license on
October 5. Until that happened, Crawford said, the FDA had been assured by the
company, Chiron
(CHIR), that contamination reported Aug. 25 was limited and that 46 million
to 48 million doses would be shipped to the USA early in October.
Unless you meet these
stringent criteria for
being "at risk" you probably won't get a flu shot this year. The CDC is
asking healthy people 2 to 64 years of age not to get vaccinated this year
at all or to wait to get their vaccine after persons in priority groups in their
area have had a chance to be vaccinated. Basically they are shifting the burden
of their failures onto the most vital citizens of our country.
Talk to your doctor about Flumist, and the
following prescription antiviral drugs: amantadine (Symmetrel), rimantadine (Flumadine),
Relenza (Zanamivir), and oseltamivir (Tamiflu).
Read this
FDA
report on influenza antiviral drugs. Also, since you can be contagious from
a day before you get sick to a week after symptoms appear, wash your
hands often and cover your mouth when you cough. If you do get sick, stay home
at the first sign of illness.
Within the peculiar logic of human nature, scarcity creates value. We most
want what we can least have. Psychologists call this the scarcity principle.
The scarcity principle has logical origins. Because intrinsically
valuable items such as precious metals, or uniquely talented people are scarce,
scarcity can help alert us to truly valuable items. However, artificially
created shortages don't increase the intrinsic value of an item. Wanting
something because it is intrinsically valuable makes sense. Wanting something
because you can't have it is nonsense. Looking back on the
gasoline shortage of 1973,
Cabbage Patch Kids,
Tickle
Me Elmo, and the
Furby
crazes provides a rational perspective on the hysteria of shortages. Do
you want a flu shot more this year than last year? Perhaps you are reacting to
the shortage, rather than to the value of the flu shot.
Psychology's
reactance theory states that when we perceive an unfair loss of
freedom, we respond by wanting that freedom even more than before, and we
become determined to act. In every previous year we were free to choose whether
or not we wanted to get a flu shot. This year that freedom has been abridged,
suddenly and unfairly. This activates a reactance state which is an intense
emotional , single-minded, and somewhat irrational urge to get back the freedom
that was usurped. People are waking up at 3 am to stand in line to get the flu
shot they feel they justly deserve, even if they skipped the shot last year.
Two factors that heighten the effect of the scarcity principle are also at
work during this flu vaccine shortage. First, the scarce item has its highest
value when the scarcity first becomes apparent. The sudden announcement of the flu vaccine
shortage brings attention to this new scarcity, and leads to the corresponding increase in perceived
value. Second, people are most attracted to scarce items when we have to compete
with other people to get them. This effect explains the bidding frenzy that can
occur at an auction. The long lines at the flu clinics makes this competition
very visible and increases the perceived value. A bidding frenzy for flu shots can break out.
You may be able to determine if you are reacting emotionally or rationally
(cognitively) to the scarcity. If you feel a physiological arousal when
confronted with the scarcity, this is the emotional reaction predicted by
reactance theory. If you coolly and calmly assess the situation, you are
thinking rationally.
References:
Influence: The Psychology of Persuasion,
by Robert B. Cialdini
Extraordinary Popular Delusions & the Madness of Crowds,
by Charles MacKay
Psychological Reactance,
by S. S. Brehm & J. W. Brehm, ISBN
0121298507
A Colossal Supplier Management Failure
Effective supplier management is critically important to the smooth operation
of any business or organization. A factory transforms raw materials into
finished products. If the raw materials are absent, defective, late,
contaminated, unsuitable, or too expensive, then the finished product will
suffer from these deficiencies. The food served by a catering service cannot be
any fresher or safer than the groceries they use to prepare the foods.
Similarly, the vaccine injected by your doctor, health clinic, or pharmacy, is
no safer, effective, or available than the serum they obtain.
Modern supplier management theory and practice emphasizes reliance on a small
number of trusted and effective suppliers for each item purchased. An important
part of this approach is the careful selection of suppliers, followed by a close
ongoing relationship. The criteria used to select suppliers include
assessment of the supplier’s management style and capabilities, including their
quality management system, their reputation, their history of delivering similar
product, and many other factors relating to their ongoing ability to deliver suitable
product. The ongoing relationship includes close collaboration between the
purchaser and the supplier on product specifications and ongoing communication
regarding the progress, problems, quality, and schedule of manufacture and
delivery of the supplies. It is essential for this relationship to be based on
mutual trust, so that problems the supplier is facing are brought quickly to the
attention of the purchaser.
Early supplier
involvement allows the suppliers to partner extensively with the purchaser,
influence important decisions, and share in the success of the final result.
A contract creates the framework for the ongoing relationship.
Critical supplies require the most effective and extensive supplier
management activities. With the health of 50 million Americans depending on the
timely delivery of flu vaccine, these supplies are extremely critical. This
requires an extremely effective supplier management system.
The supplier management needed to ensure vaccine delivery failed
catastrophically.
Said plainly, when the FDA decides to put 50 million eggs in one basket, they
have an obligation to: 1) choose the basket carefully and, 2) watch that basket
very closely. These fundamental obligations were certainly not fulfilled,
because we don’t have any vaccine as a result.
Basic questions regarding supplier management for the flu vaccine need to be
asked and answered. These questions include:
What U.S. organization is the purchaser responsible for supplier
management for flu vaccine?
What supplier management responsibilities have been in place to ensure an
adequate supply of influenza vaccine?
What other manufactures were considered before Chiron was chosen? Why was
a foreign company chosen rather than a U.S. company?
What incentives did the purchaser provide to attract bids from qualified
flu vaccine manufacturers?
What prior experience does the US have in purchasing flu vaccine from
Chiron?
When did the purchaser first involve Chiron in working to provide the U.S.
flu vaccine needs?
Did Chiron provide influenza vaccine to US customers last year or in any
previous years? If so, in what quantities?
Describe the nature of the supplier quality system audits that the
purchasing organization or other US based purchasers conduct on Chiron.
Describe the relationship between the UK regulatory body, the Medicines
and Healthcare Products Regulatory Agency, and the FDA in monitoring this
supplier contract.
How often does the purchaser communicate with Chiron? What is the nature
of that communication? When did the purchaser first suspect there may be some
problem? How does the purchaser prevent problems?
Has Chiron undergone any significant changes or restructuring that could
possibly affect their product quality or manufacturing capabilities?
Describe Chiron's quality management system.
What specific failure is the cause of the present flu vaccine shortage?
Indicate the proximate cause, and each contributing factor through to the root
cause.
Describe the contracts; including provisions for surveillance of
manufacturing capability, maintenance of the quality management system,
monitoring and acceptance of product, and any contingency or penalties that
pertain between Chiron and their US based purchasers of influenza vaccine.
These questions have been posed to the Director of the CDC, the Surgeon
General, the acting Commissioner of the Food and Drug Administration, and the
Secretary of Health and Human Services. Their responses will be published here
as they are received.
References:
Out of the Crisis,
by W. Edwards Deming
Juran's Quality Handbook,
by Joseph M. Juran, A. Blanton Godfrey
Essentials of Supply Chain Management,
by Michael H. Hugos
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