Biology Reference
In-Depth Information
The 2003-4 flu season brought another vaccine disaster: a virulent strain of annual influenza (H3N2
Fujian), which was not included in the vaccine mixture, proved more dangerous than expected to small
children, and the old-fashioned egg-based production system precluded any last-minute reformulation of
the vaccine. Even with a component missing, vaccine demand rose steeply; however, the two manufactur-
ers, wary of being stuck with an excess supply as they had been the previous year, had manufactured too
little, and some localities had to resort to rationing. While HHS had foreseen the likely shortfall, they had
failed to exert enough pressure on the manufacturers to increase production.
As the media headlined stories about children in Texas and Colorado dying from the Fujian strain,
the CDC was nervously monitoring the new, extraordinarily widespread outbreak of H5N1 in Asia. Sec-
retary Thompson finally acknowledged—although with less urgency than previous announcements about
anthrax and smallpox—that a flu pandemic was an imminent danger, and the administration promised
to accelerate vaccine development. Despite widespread criticism of their conduct during the previous flu
season, Thompson decided to again make Aventis-Pasteur and Chiron the twin pillars of the U.S. vaccine
program. In May both corporations received contracts from the National Institute of Allergy and Infec-
tious Diseases to produce experimental lots of an H5N1 vaccine using a seed strain from Robert Webster's
laboratory at St. Jude; in mid-August, Chiron was also awarded the contract to develop a vaccine against
the H9N2 subtype.
In retrospect, it is hard to fathom Thompson's confidence in Chiron. Under a succession of previous
owners, its Liverpool plant had developed a notorious reputation for contamination. “It is an antiquated
facility and poorly managed” was the opinion of one business analyst. 267 British authorities had once re-
called contaminated polio vaccines made in the plant, while the FDA had admonished a previous owner
about impurities in its flu vaccine. In the summer of 2003 FDA inspectors discovered significant risk of
bacterial contamination in twenty different production activities, especially in the sterilization processes;
because the plant was responsible for manufacturing almost half of the U.S. vaccine supply, the inspec-
tion team recommended compulsory steps to mitigate the danger. Their superiors, however, insisted upon
voluntary, rather than mandatory, compliance. The agency then curiously delayed for nine months before
forwarding Chiron its full inspection report, and, instead of sending inspectors back to monitor Chiron's
progress, FDA officials consulted with the company by telephone or email. Lester Crawford, the acting
head of the FDA, later assured a skeptical congressional committee that since the 2003-4 vaccine was ac-
ceptable, the FDA considered Chiron's Liverpool problems resolved. (“They had in fact completed what
we wanted them to do.”) 268
The FDA's timidity and Crawford's nonchalance angered U.S. Representative Henry Waxman of Cali-
fornia and other members of the House Committee on Government Reform, but they also knew that the
agency's policy of sleeping with the enemy, or rather, “working with the pharmaceutical industry as a trus-
ted partner,” had been promoted by the Clinton administration—supposedly in order to speed production
and approval of “breakthrough drugs.” Critics of Big Pharma, on the other hand, saw the FDA's “partner-
ship” with Chiron as classic evidence that another regulatory agency had been captured by the industry it
was supposed to regulate.
In July 2004 Chiron found Serratia marcescens —a bacteria that can cause deadly septic shock—in
several batches of vaccine. Instead of immediately alerting the FDA, the company instead issued a press
release “boasting that it already had shipped 1 million doses of Fluviron vaccine to the U.S. market and
planned to ship 52 million more doses.” Chiron waited more than a month, until 26 August, to notify the
FDA of contamination. Once again, Crawford trusted the corporation to rectify the problem. At the end of
September, Chiron CEO Howard Pien personally reassured the Senate Committee on Aging that quality
control had been restored to the Liverpool plant, which would soon ship 48 million doses of vaccine to the
United States; instead, a week later, vigilant British inspectors shut the plant down and revoked Chiron's
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