Superior?
According to a press release issued by Roche,
actually this was titled an Investor Update:
“The
results of T-emerge 1 showed that taspoglutide demonstrated superior HbA1c
reduction versus placebo. The study analysis included 373 patients, enrolled
into three arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly
titrated up to 20mg once weekly after 4 weeks, and placebo).”
Looking through the entire update there was no
mention as to exactly what superior A1C reduction means, as the company did not
disclose the amount of A1C reduction for patients taking taspoglutide. This is
not the first time Roche has issued either a press release or investor update
on taspoglutide touting its supposed superiority but giving no actual data to
back up this claim.
Hoping that the company would actually back up
their claim that taspoglutide was “superior” Diabetic Investor called Thomas Kudsk
Larsen who’s listed as a Roche IR contact. When asked why the company did not
provide any real data to back up their claim, Mr. Larsen stated that doing so
would not allow the company to present the data at the American Diabetes
Association Scientific Sessions in June 2010. Diabetic Investor found this
explanation strange considering Amylin (NASDAQ:AMLN), Novo Nordisk (NYSE:NVO)
and Sanofi-Aventis (NYSE:SNY) are just a few of the companies who have released
actual data and presented more detailed explanation of this same data at ADA.
When asked why these companies, who actually
backed up their claims, were allowed to present at ADA even after releasing
real data, Mr. Larsen smugly commented that Roche does not need to back up
their claims as this is the company’s interpretation of the rules.
Giving Roche the benefit of the doubt,
Diabetic Investor spoke with several companies who have released real data who
also presented more detailed explanations of this same data at ADA to see how they
interpreted the rules. Not surprisingly we received a wide range of
explanations, or put another way what one person sees as a glass half empty,
the other sees as a glass half full. About the only thing that became clear
here is that when it comes to these “rules” it’s really the Wild West out
there. Or as Oliver Wendell Holmes once noted; “Lawyers spend a great deal of
their time shoveling smoke.”
So what are we to take away from these claims
being made by Roche? Is taspoglutide really “superior” or is the drug merely on
par with others in the category or is it actually inferior to the competition?
The reality here is no one but Roche really knows the answers to these
questions and they don’t seem to care what anyone else thinks. Although
Diabetic Investor has no direct knowledge that there is anything wrong with the
Roche data, based on the real data we have seen from other GLP-1 drugs we doubt
that Roche’s real data is anything special.
Based on what has been made public to date on
taspoglutide it appears to have the same side effect and adverse event profile
as other GLP-1’s. It’s also dosed like other GLP-1’s. While it is possible that
taspoglutide is truly something special and unique, it’s more likely it’s just
one more GLP-1 that does a good job of lowering A1C with the additional benefit
of weight lose. Although
Diabetic Investor finds it just slightly interesting that the investor update
makes no mention of weight lose.
The real story here isn’t what taspoglutide
does or does not do. The real story is Roche playing very fast and very loose
with the “facts”. To Diabetic Investor
nothing is more arrogant than stating your product is superior and then not
having the stones to back up this claim. Diabetic Investor is used to this attitude
from their diagnostics unit but didn’t believe this attitude extended to their pharmaceutical
unit.
Winston Churchill once said; “The only wise
and safe course is to act day to day in accordance with what one’s own
conscience seems to decree.” Based on both their words and actions, the people
at Roche either don’t have a conscience or just don’t give a damn. Either way someone should hold the
company accountable and Diabetic Investor plans on doing just that.
