Managing in the Gray
88
In the days after getting the PML news, Jim Mullen took
a similar approach to what was, of course, a vastly more
complex, uncertain, and politically charged problem than
Friedman’s. He immediately informed the FDA, overseas
regulators, and the Biogen Idec board about the PML cases.
Then he and his senior team spent a week scouring the world
for information on PML to learn all they could about the risks
to patients. Mullen didn’t know whether a week of intensive
effort would find evidence of a link between the new drug
and a very rare disease but, like Friedman, Mullen decided to
learn what he could without overcommitting.
Once he did know more—or found that he would be
unable to learn more quickly—he could pursue other options.
But this approach avoided the risk of a premature announce-
ment that might undermine confidence in the drug, possibly
trigger a panic among patients, and harm the company. It
also gave Mullen and his senior team some time to carefully
assess various possibilities and the steps Biogen could take if
any of these possibilities became real.
In the end, Jim Mullen had started a process that lasted
more than a year. After his week of information gathering,
Mullen and his senior team decided to temporarily suspend
distribution of Tysabri, rather than withdraw it permanently.
This gave them the option to reintroduce the drug, depend-
ing on what more they learned and the protective measures
they might be able to create. A suspension may have also pla-
cated, to a degree, the MS patients, physicians, and members
of the US Congress who wanted Tysabri available.
Once he created some breathing room, Mullen initiated a
long and complex process, aimed at making Tysabri available
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