a February 2007 press release,
Abraxis BioScience reported record revenue of $765 million in 2006
versus $521 million for 2005. They made that money selling a
new version of an old cancer drug at $4,200 per dose.
That new drug is called Abraxane and it
has pushed Abraxis BioScience stock from $5 in 2002 to $27 in 2007.
The lofty stock price has made Abraxis CEO and Chairman, Dr. Patrick
Soon-Shiong a billionaire; Dr. Soon-Shiong owns 84 percent of the
stock, today worth about $3.8 billion.
Dr. Patrick Soon-Shiong has been criticized for hyping his research
results and he has been accused of ripping off investors. Even his own
brother, an early backer, sued him for fraud and fired him -- twice --
from the company they started. Their fight lasted two years and
destroyed their relationship. But in the end, it is Dr. Soon-Shiong
who has prevailed.
Today, Dr. Soon-Shiong is making money hand over fist. After all, his
“new” drug costs 25 times more than an older, generic version
(paclitaxel). There is, however, little difference between the new
drug and older therapy; in fact, they both use the same active
molecule. The only difference is that in Abraxane paclitaxel is bound
to a protein, to make it easier to inject. And Abraxane doesn’t help
patients live longer than the old, generic, version of the drug.
It is also noteworthy that an
independent review article of Abraxane and similar drugs in
“Annals of Oncology” concluded, “do these agents represent anything
more than old wine in a new bottle? With currently available data, we
have to say, ‘not really’.”
So how has Abraxis BioScience been able to sell so much of a drug that
isn’t really much better than the old version and how has Dr. Patrick
Soon-Shiong been able to get so rich?
Some AstraZeneca oncology sales reps think they have part of the
answer. They claim that those rapidly escalating sales may have been
built upon off-label marketing.
AstraZeneca co-promotes Abraxane with Abraxis BioScience, and those
sales representatives claim that at a joint sales meeting between
AstraZeneca and Abraxis, which took place in December 2006 in
Pittsburg, things went awfully wrong.
The meeting was led by AstraZeneca Regional Sales Director Mike
Zubillaga, who has since been terminated by AstraZeneca, together with
an Abraxis Medical Science Liaison (MSL) and two District Sales
Managers; one from Abraxis and one from AstraZeneca.
Eight AstraZeneca oncology sales reps and eight Abraxis reps
participated in the training, and they received the assistance of a
whopping seven oncologists, who made some extra cash, tutoring the
sixteen sales reps.
According to some of those AstraZeneca sales reps, the Abraxis Medical
Science Liaison made it known that the Abraxis MSLs were available for
off-label discussions (such as lung cancer) with oncology doctors, and
that the AstraZeneca reps should use them as a resource. Then the
Abraxis District Sales Manager allegedly pointed out that coordination
of these meetings should be done by cell phone only, and that email or
voicemail should be avoided.
If these allegations are true, this all sounds very familiar.
In May 2004, Pfizer’s subsidiary Warner-Lambert paid a $430 million
fine for off-label promotion of Neurontin. The Department of Justice
stated that Warner-Lambert “utilized "Medical Liaisons," who
represented themselves (often falsely) as scientific experts in a
particular disease, to promote off-label uses for Neurontin.”
And the sales efforts for Abraxane are clearly paying off. Over 20,000
people have been treated with Abraxane, and sales are expected to
reach $1 billion by 2010.
But that may not be how things play out.
Because those concerned AstraZeneca sales reps who participated in the
meeting with Abraxis BioScience didn’t stay silent. They claim a “Code
of Conduct report was submitted through the AstraZeneca hotline
shortly thereafter.” They also told me that, “thus far we are not
aware of any investigation or interviews by AZ. No official response
from them as of today.”
So when AstraZeneca took no visible action, and did not respond, the
AstraZeneca oncology sales reps decided to talk to me. And that’s the
reason you’re reading this story today.
UPDATE: AstraZeneca has now responded to the sales reps. Five
months after the first report was made, they finally left a message on
the hotline for their internal whistleblowers, AFTER the story was
leaked to the press.
M.D., is a former Vice President of Pfizer. He is the author of
The Whistleblower: Confessions of a Healthcare Hitman.
He also writes the daily
Dr. Peter Rost blog.