By Ted
Whitford October 28, 2019
I worked
on and around aducanumab, an experimental treatment for Alzheimer’s, for years
during my time at Biogen. I thought it was going to work. I wanted it to
work — my father had died of Alzheimer’s disease. It was awful watching his
mind disintegrate over the course of a decade, which made me even more hopeful
for a positive outcome for aducanumab.
I had
also worked on dexpramipexole, a molecule that Biogen and Knopp Biosciences
were testing as a treatment for amyotrophic lateral sclerosis (ALS), also known
as Lou Gehrig’s disease. I wanted it to work, too, since one of my close
friends had ALS. He was taking part in the trial for the drug, which made me even
more hopeful for a positive outcome.
But dexpramipexole didn’t work
any better than the placebo it was being tested against. I cried the day I
found out. I remember sitting in a bathroom stall in Biogen’s building in
Weston, Mass., with tears dropping onto my gray business casual trousers,
crushed by the knowledge that my friend wouldn’t be helped, nor would countless
others.
That day,
George Scangos, who was the CEO of Biogen at
the time, called an all-company meeting just after lunch. He asked that
everyone stop what they were doing and come to the auditorium to talk about
dexpramipexole.
George
wasn’t a natural public speaker, and at times it showed. On that day, though,
he walked to the podium without a discernible shred of discomfort. He stood
calmly in front of the company, investors, and the media and, with a presence I
had never before seen, told the crowd in no uncertain terms that dexpramipexole
did not work and would not be a treatment for ALS.
He said
the results made him profoundly sad, but made it clear that Biogen would do no
fishing for false signals in subtypes or subgroups that, in the picked-over
carcass of the dataset, may have appeared to have responded to the drug.
He said
it was important to have the integrity to admit failure when failure was clear
and how it was our responsibility to respect patients and their families by not
giving them false hope. He then shared his resolution that Biogen would not
stop fighting ALS and the company would focus its capital, time, and effort on
the next generation of therapies.
Biogen’s
stock got hammered, dropping more than 8% that day. Yet I’d never been more
proud than I was that day to work for George and for Biogen, having seen for
years companies hem and haw at negative results and claim that if you squint
and look sideways that the molecule really did work, hoping that investors
would have mercy on the stock price — and in the process ignoring the responsibility
to be honest and forthcoming to patients and their families.
When I
learned last week that Biogen had completed a retrospective analysis of the aducanumab data
— the same data that seven months earlier the company had said justified
stopping work on the drug — I thought of my father, my friend, George Scangos,
and people around the globe with Alzheimer’s, ALS, and other diseases for which
there are no cures.
I hope
that Biogen made a mistake in its futility analysis back in March. But if it
didn’t, and this is another example of the American public watching big pharma
trying to spin bad data, then I can’t help but wonder if Biogen, and perhaps
the industry, has lost its way.
Ted
Whitford is a veteran of the biotech industry who now privately invests in the
health care market.
No comments:
Post a Comment