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"Protecting the health and informed consent rights of children since 1982."

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NVIC President and Co-founder Barbara Loe Fisher, who served as the consumer
voting member of the FDA Vaccines and Related Biological Products Advisory
Committee was the sole dissenting vote opposing licensing of FLUMIST vaccine
on the grounds that the vaccine manufacturer had not proven safety.

FROM www.worstpills.org

Foggy Thinking as Inhaled Flu Vaccine Nears FDA Approval

    Worst Pills, Best Pills News article February, 2003
It seemed like a great idea. Perhaps a vaccine that could be administered
with a simple sniff in each nostril, rather than a painful jab, could revive
languishing flu vaccination rates in people at risk for the complications of
influenza (mostly those over 65 and those with underlying heart disease,
lung disease or diabetes). But then public health and science came into
conflict with profit - and we all know how that all-too-often turns out.Back
in 2001, FLUMIST, an influenza vaccine made from live rather than killed
virus, came before a Food and Drug Administration (FDA) Advisory Committee,
seeking approval for use in healthy people aged 1-64 years. But the
Committee soon detected hints that the vaccine was causing asthma in young
people and requested more information. The vaccine's sponsor reached deep
into its bag of corporate tricks and came up with the notion not of
redesigning the vaccine to minimize its asthmatic propensity, but rather of
seeking approval only for people 5 years old and above. Sure, FLUMIST's
market would be reduced, but MedImmune's stockholders would be happy that
the vaccine was approved. Besides, everyone knows that doctors often
prescribe "off-label" (outside of FDA guidelines) and drug companies'
"detail men" are famous for encouraging such off-label prescribing.But this
created a small scientific problem. The best designed study demonstrating
FLUMIST's effectiveness (because it measured actual decreases in
laboratory-proven influenza vaccination) included 1-7 year olds, but now
most of that age group was excluded from the new target population. And the
study in adults 18-64 only measured clinical disease, rather than the more
accepted standard, in which laboratory proof of the presence of influenza
virus is required. Moreover, the adult study failed to demonstrate
statistical improvement in the main clinical outcome ("any febrile
 illness"), although it did for many of the secondary outcomes (e.g.,
"febrile upper respiratory infection"), and included relatively few people
over the age of 50. In fact, in an analysis of the 50-64 year olds planned
after the study was complete, there was little evidence of vaccine efficacy,
even for the secondary outcomes. The studies also showed that, despite
investigators' efforts, many patients with asthma, who were supposed to have
been excluded from the trial, slipped through and were vaccinated. This is
likely to be even more common in actual clinical practice.In a complicated
vote, the Advisory Committee decided that there was insufficient evidence of
vaccine efficacy in 50-64 year olds. The Committee thus in effect
recommended approval exclusively for those for whom the Centers for Disease
Control and Prevention (CDC, like FDA, a part of the Department of Health
and Human Services) does not recommend flu vaccination: healthy people aged
5-50. The vote was also a landmark in that, with the support of the FDA, it
permitted approval for a vaccine based on clinical rather than laboratory
outcomes (recall that laboratory-confirmed outcomes were available only for
the five, six and seven year olds). And a live virus vaccine at that, with
concomitant risks of transmission to unvaccinated persons.Compounding these
problems was the FDA's failure to insist on any studies comparing FLUMIST to
the existing killed virus vaccine. So consumers and physicians are left in
the lurch, devoid of the data that should have been produced prior to
approval and now probably never will be generated.What You Can DoIf the FDA
follows its Advisory Committee's recommendations, as it usually does, what
are consumers to do? We recommend that you stick with the CDC, which is more
immune to industry influence than the FDA. (At least the CDC is not
dependent upon the industry it regulates for a large portion of its
funding.) If you're over 65, get vaccinated. If you're between 50 and 64,
get vaccinated if you are in a high-risk group. In any event, get vaccinated
with the old, proven inactivated flu vaccine, rather than one with so much
murky science behind it as FLUMIST. We also do not recommend the use of
RELENZA (zanamivir) and TAMIFLU (oseltamivir) in the treatment of influenza.
(These products were discussed, respectively, in Worst Pills Best Pills News
's January 2002 and January 2000 issues.)