HOW THE MASS
MEDIA IN THE U.S. CREATED FLU HYSTERIA AND HELPED DRIVE THE
VACCINE MARKETS FOR THE MAKERS OF FluMist AND FLUZONE
by RFD Columnist, Dr. Sherri
Tenpenny
www.redflagsweekly.com
October 2004
The hype regarding this
year’s flu “epidemic” continues. In the wake of the
media-induced hysteria, a fascinating series of
chronologically connected events has materialized that appears
to protect the pharmaceutical industry profits at the expense
of our children. This issue demands further examination.
On June 20, 2002, the Advisory Committee on Immunization
Practices (ACIP) adopted a resolution to include the influenza
vaccine in the childhood vaccination schedule. The influenza
vaccine will be recommended annually to all children aged 6
months to 23 months, and to children aged 24 months to 18
years who are household contacts of children aged less than 2
years. After becoming effective on March 1, 2003, the
resolution was implemented during the 2003-04 influenza season
and the vaccine will be encouraged annually, for every
subsequent flu season, in other words, creating “regular
customers for life.”
Coming on the coattails of this announcement, the FDA approved
the use of FluMist, the first nasally injected vaccine. The
company originally had sought an indication for use in healthy
people aged 1-64 years, but it was denied by the FDA. Reports
suggested the vaccine caused a 3.53-fold increased risk of
“asthma events” after the first dose in children 12-59 months
of age.After a 32-month review that included the submission of
additional data, the decision was reversed and on June 17,
2003, the FDA issued a license to Medimmune to produce FluMist,
a live attenuated influenza vaccine for use in 5-to-49 year
olds. In a complicated vote, ACIP decided that, because only
641 adults over 50 years of age were studied, there was
insufficient evidence of vaccine efficacy in 50-64 year olds.
MedImmune Inc., FluMist’s manufacturer and Washington DC’s
successful biotechnology company, was jubilant over the
decision. When MedImmune executives and Wall Street bulls
learned that FluMist would be released in time for the fall
flu season, MedImmune's stock soared to $43.32 per share, more
than 63 times earnings. MedImmune announced it would
manufacture between 4 million and 6 million units of FluMist
for the 2003 season.
A $25 million marketing campaign was launched in October by
MedImmune, and its partner, Wyeth, to create a demand for
their new product. Ad after ad demonstrated the inconveniences
the flu caused to family members and co-workers, encouraging
everyone to get their flu shotespecially the shot up the
nose. It just so happened that flu outbreaks began to be
reported in Houston earlier than in previous years and about
the same time as FluMist began to be used. Texas Children's
Hospital diagnosed 40 patients with the flu in five days.
During comparable weeks of the flu seasons in the previous two
years, only 9 cases per week had required treatment.
However, despite the best efforts of a massive marketing
blitz, the big demand for FluMist didn’t materialize. The
“billion dollar blockbuster” lacked the appeal its creators
had dreamed about. The advantage of a getting a mist up the
nose over a shot in the arm couldn’t justify the hefty price
not covered by health insurance (FluMist for $60-70 vs. flu
shot for $7).
By November 17, MedImmune had reduced its 2003 fourth quarter,
full-year revenue expectations as earnings were projected to
be $60 million less than anticipated. MedImmune’s CEO, David
M. Mott, stated that he was “disappointed.” Half-way through
the 12-week peak “immunization season” the anticipated demand
was just not there. Perplexed, MedImmune announced on November
23 that it had “hired a consultant to discover why its
needle-free flu vaccine, FluMist, had disappointed sales
expectations this fall and was considering placing the
emphasis on FluMist's safety as well as its convenience.”
Shortly thereafter, the outbreaks initially seen in Texas were
being reported all around the countrymuch earlier than
usually anticipated. Indeed, even a few children were reported
to have died from the flu. The media hyped these reports as
though this were an outbreak of smallpox instead of the flu,
causing hysteria.
With the announcement of the “flu epidemic” blazoned from
every conceivable form of news report, a stampede of patients
arrived at doctors’ offices, demanding a shot to ward off the
“deadly strain” of influenza. Parents especially wanted their
children vaccinated, and were willing to drive to cities hours
from home and even stand in line for up to 90 minutes.
But wait.
Doesn’t the CDC say repeatedly that 36,000 people die every
year from the flu? Were these reported deaths indicative that
all deaths possibly related to the flu might be different or
more numerous than deaths reported any other year? In a
telephone interview on November 17, 2003, this is what the CDC
had to say:
MODERATOR: Miriam Falco from CNN, your line is open.
QUESTION: Hi, Dr. Gerberding, thanks for doing this. Is this
the most serious early onset since 1976?
DR. GERBERDING: This is early onset from the standpoint that
we have more cases, particularly in Texas, where we see it's
fairly widespread [outbreak] of flu. But we have had many
years where flu has started early and peaked earlier than
average. So it's a little too early in the game to say whether
or not this portends the worst flu season we've had in a long time.(emphasis mine)
Again, on December 11, 2003, Dr. Julie Gerberding reported the
following during a CNN teleconference:
“We don't have scientific evidence or epidemiologic evidence
to suggest that this year's influenza outbreak is worse than
it has been in the past or that the strain is more virulent
than strains that we've dealt with before. It's just simply
too early in the course of the outbreak to say for sure how
this will compare overall…” (emphasis mine)
If that is the case, isn’t the “epidemic” being reported
nationwide by the media a little like yelling “fire” in a
crowded theater…when there is no fire? People can be harmed
and even killed by the ensuing stampede.
Further evidence suggests that the outbreaks did not deserve
the feeding-frenzy level of media coverage they have received.
For example, the Rocky Mountain News reported on December 11
that officials said flu cases had been cut in half and the
“the worst of worst Colorado season in years is over.” The
report went on to say that, “during a typical year, no more
than two children and a total of 750 to 800 Coloradoans die of
complications of the flu or pneumonia." Do nine reported
deaths in children make this year the "worst of the worst"?
Does an increase of 7 deaths over previous years constitute an
epidemic?
In Arizona, the Department of Health Services reported on
December 11, 2002 that two adults and one child had died of
influenza related sickness. Michael Murphy, the health
department’s spokesperson, said that Arizona typically has 20
children deaths a year caused by influenza. Is one death an
“epidemic”?
This does not in any way minimize the tragedy of the death of
a child. What needs to be put into context is how
extraordinarily small these numbers are to lead to such
media-driven hysteria. Furthermore, what were the underlying
health conditions of those who died? At least one other report
stated that one of the children in Colorado died of the flu
and “other causes.” A 3-year-old boy who reportedly died from
complications of the flu at Children's Medical Center in
Dayton also had a missing pituitary gland and a cleft pallet.
Both conditions can be associated with a compromised immune
system. Perhaps the CDC should recommend giving the flu shot
only to children at highest riskand their immediate family
membersinstead of encouraging mass vaccination of children
with normal, intact immune systems.
Do we know if the reports of “flu-related illness” and death
were actually caused by an influenza virus? The CDC reports
that the majority of influenza-like illnesses are not caused
by the influenza virus, but by other viruses (e.g.,
rhinoviruses and respiratory syncytial virus [RSV]),
adenoviruses, and parainfluenza viruses). Douglas Benevento,
executive director of the Colorado Department of Public Health
and Environment stated the department's definition of
"flu-related illness" includes kids who have flu symptoms but
haven't had a confirmatory test.
By early December, reports began to come out that stated the
viral strain of this year’s flu “epidemic” was the A/Fujian
strain. This was a serious error on the part of the vaccine
program because the most virulent strain of the flu identified
this season was not part of FluMist or Fluzone. In order to
continue encouraging vaccination, the CDC proclaimed that the
flu vaccines “should” confer “some” protection against this
strain. The media continued to blare: get your flu vaccine.
The CDC estimates that only 13 percent of healthy people less
than 50 years of age, or about 17 million Americans, got flu
shots last year. Typically, 80 million doses of the flu shot
are manufactured annually. Therefore, millions of unused doses
of the flu vaccine from the previous year’s stock are
discarded, along with the profits connected to them. With all
this attention on the flu, Aventis certainly benefited. As the
manufacturer of Fluzone (the “flu shot”), it is interesting to
note that Aventis stock rose from $48/share at the beginning
of September to $61.43 on December 12. The extra,
unanticipated Fluzone sales may not be the sole contributor to
the stock increase, but certainly this can be considered as
playing a role.
Predictably, the demand for the flu vaccine soon outstripped
supply. In an effort to assist health officials, effective
December 10, 2003, Wellmark Blue Cross and Blue Shield was one
of many insurance carriers that began covering the cost of
FluMist vaccine through the end of December, or through the
vaccination time period recommended by the CDC for the
2003-2004 flu season.
Now, even the government is getting on the band wagon to
support consumer use of FluMist. Negotiated by the CDC, the
agreement will allow state and local officials to purchase the
nasal-spray vaccine for $20 a dose from now through the middle
of February from both MedImmune and Wyeth. At less than half
of the suggested wholesale price of $46 per dose, this may be
the ultimate boost to faltering sales.
The upshot of the run on flu shots, the newly implemented
insurance coverage and the boost from the federal government
has surely created a bonanza for MedImmune. The company
probably hasn’t had to spend an additional marketing dime to
implement the ideas of its newly hired consultants. Much of
its marketing was accomplished for free…through the Six
O’clock news.
