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 Dr. Sherri Tenpenny
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, [i] 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.[ii]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.[iii]
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.[iv] 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 shot—especially 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.[v]
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.[vi] 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.”[vii]
Shortly thereafter, the outbreaks initially seen in Texas were being reported all around the country—much 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.[viii]
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.[ix] (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…”[x] (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." [xi] 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.[xii] 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.[xiii] Both conditions can be associated with a compromised immune system. Perhaps the CDC should recommend giving the flu shot only to children at highest risk—and their immediate family members—instead 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).[xiv] 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.[xv]
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.[xvi] 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.[xvii] 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.[xviii]
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.[xix]
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.
[i] MMWR. September 27, 2002/51(38);864, 875
[ii]ePediatric News. July 2003, Volume 37, Number 7.
[iv]The Washington Post. MedImmune's Pain-Free Ambitions. March 18, 2002; Page E01
[vi] PRNewswire November 17, 2003
[vii]Washington Post. November 25, 2003. “MedImmune Seeks Help in Relaunching FluMist.”
[viii]Rocky Mountain News. December 11, 2003 “Cases of flu cut in half.”
[ix] CDC News Conference Transcript. November 17, 2003. Update on Current Influenza Season.
[x] CDC News Conference Transcript. December 11, 2003. Influenza Update.
[xi] Rocky Mountain News. December 11, 2003 “Cases of flu cut in half.”
[xii]The Navaho Times. December 11, 2002. “Flood of flu cases using up vaccine.”
[xiii] December 15, 2003. “Toddler Dies Of Flu Complications”
[xiv] MMWR November 9, 2001/50 (44); 984-6
[xv] Rocky Mountain News. December 11, 2003 “Cases of flu cut in half.”
[xvi] Washington Post. June 18, 2003, Pg. A01. “Spray Vaccine For Flu Wins FDA Clearance.”
[xvii] Forbes Financial Report.
[xix] The Washington Post. Tuesday, December 16, 2003; Page E01Government To Purchase FluMist at A Discount. Deal Could Give Boost To MedImmune Vaccine