News
Diabetes Rivals Lick Chops Over Avandia Setback
The FDA will be slow in approving new diabetes
treatments. That's not great news for existing drugs.
Over the weekend the U.S. Senate Committee on Finance
released a report that looks to put the final nail in the Avandia
coffin.
According to a letter attached to this report by Senators
Max Baucus, D-Mont., chairman of the committee, and Charles E. Grassley,
R-Iowa, ranking minority member: "The totality of evidence
suggests that GlaxoSmithKline ( GSK - news - people ) was aware
of the possible cardiac risks associated with Avandia years before
such evidence became public."
The senators continue, "Based on this knowledge,
GlaxoSmithKline had a duty to sufficiently warn patients and the
FDA of its concerns in a timely manner. Instead, GlaxoSmithKline
executives intimidated independent physicians, focused on strategies
to minimize findings that Avandia may increase cardiovascular risk
and sought ways to downplay findings that the rival drug ACTOS (pioglitazone)
might reduce cardiovascular risk."
GlaxoSmithKline, the company behind Avandia, responded
to this report with a letter of its own which stated, "The
Staff Report of the Senate Committee on Finance draws conclusions
on the safety of Avandia(rosiglitazone) that are based on analyses
that are not consistent with the rigorous scientific evidence supporting
the safety of the drug. In addition, the report cherry picks information
from documents, which mischaracterizes GlaxoSmithKline's comprehensive
efforts to research Avandia and communicate those findings to regulators,
physicians and patients. In fact, the safety and effectiveness of
Avandia is well characterized in the label approved by the FDA."
Before we examine the fallout from this battle between
GlaxoSmithKline, the U.S. Senate and the Food and Drug Administration,
it's worth noting a few facts. In 2006 worldwide sales of Avandia
peaked at $2.6 billion. In 2009 worldwide sales of Avandia had fallen
to $721 million. For all practical purposes Avandia was already
dead in the eyes of physicians who, as the sales numbers indicate,
have been switching patients from Avandia to other medications.
There is no such thing as an absolutely safe drug,
and even after surviving the rigorous and expensive approval process
there are no guarantees that once on the market drugs won't reveal
adverse effects not reported during the approval process. This is
something we experienced with both Avandia and Actos, when we learned
nearly seven years after their approval of the increased incidence
of bone fractures. It's no wonder that the FDA has become so conservative
in its approach to new drug applications.
The agency must walk a delicate tightrope. It sees
diabetes growing at epidemic rates and is acutely aware of the many
comorbidities associated with diabetes. Two-thirds of all patients
with diabetes are not adequately controlling the disease, and diabetes
is not just a health care issue but an economic issue as well. Given
this set of circumstances the FDA must make a decision delicately
balancing a drug's potential benefits with what can an unknown set
of risk factors.
No one is really quite sure if Victoza causes thyroid
cancer. It's also true that for all practical purposes there is
no study that can be done that would conclusively prove a link between
Victoza and thyroid cancer.
Understanding they are caught between a rock and a
hard place, the FDA took the conservative path and approved Victoza
while putting a black-box warning on the drug's label. The FDA knows
that in the real world physicians are unlikely to widely prescribe
a new drug that comes to market with a black-box warning.
While Novo Nordisk ( NVO - news - people ) would disagree,
the FDA has effectively made Victoza dead on arrival in the eyes
of physicians, who must balance helping their patients with the
concern that one day they could be sued for prescribing a drug that
carries a black-box warning. Considering that physicians have other
options, why take the chance?
Sitting around and watching all this are the folks
at Amylin Pharmaceuticals ( AMLN - news - people ) and Eli Lilly
( LLY - news - people ) who are anxiously awaiting March 5, the
PDUFA date when the FDA is expected to complete its review of those
companies' once-weekly GLP-1 Byetta LAR. As Diabetic Investor has
previously reported, based on all available public data, there is
no reason for the FDA not to approve LAR.
Unlike Victoza LAR is basically a line extension of
Byetta, a twice-daily GLP-1, which has been on the market for nearly
five years and is used by more than 1 million patients. Again, based
on all available data, there is no reason to believe the FDA will
approve LAR with any label warnings. While Novo claims the thyroid
cancer issue is a class effect, there is no credible evidence to
support this claim.
The wild card that surely has the folks at Amylin
and Lilly nervous is whether the FDA will take extra precautions
with LAR given the current environment in Washington. As we have
noted, there is no publicly available data that would lead Diabetic
Investor to believe LAR will not be approved. However with March
5 just days away and the Avandia story making headlines, it wouldn't
surprise Diabetic Investor if the FDA delayed its decision on LAR.
To be clear, Diabetic Investor has no direct knowledge
that the FDA will delay its decision on LAR, and we believe LAR
will receive approval with no boxed warnings. Still we are cognizant
that drug approvals are not always based on the facts and that the
FDA, for good reasons, is sensitive to the convoluted environment
they must work in.
These senators, in their zeal to look like they are
actually doing something, have created more problems and provided
no true answers. As H.L. Mencken noted, "The typical politician
is not only a rascal but also a jackass, so he greatly values the
puerile notoriety and adulation that sensible men try to avoid."
Or as Boies Penrose, a former senator from Pennsylvania, eloquently
stated, "Public office ... is the last refuge of the incompetent."
The bottom line here is that as hard as it may be
to accept, every drug--prescription or over-the-counter--carries
with it some degree of risk. That no matter how many studies are
conducted there are no guarantees that a drug that looks safe when
it's approved may not develop issues later on. As Edmund Burke once
said, "You can never plan the future by the past."
It would be one thing if the senators actually offered
some constructive ideas on how we can balance the needs of the public
against the uncertainties of science instead of merely looking for
face time on TV. Instead of railing against the failings of the
FDA, why not provide some clear guidance as to what is and is not
an acceptable level of risk? Frankly any idiot can criticize after
the fact. It takes true leadership to get past placing blame and
offer solutions to the problem--but the sad fact is that leadership
is what's missing in Washington.
This report is just another hurdle for the big, bad
pharmaceutical industry. Already viewed as villains in the eyes
of the public and easy prey for politicians, they must somehow navigate
the complex maze we call the FDA.
David Kliff is editor and publisher of Diabetic Investor
newsletter. Visit diabeticinvestor.com for more commentary and analysis.
If you have been injured by Avandia contact
an Avandia Attorney.
Sheldon J. Schlesinger, P.A. represents clients throughout
the state of Florida including the cities of Boca Raton, Boynton
Beach, Carol City, Cooper City, Coral Gables, Coral Springs, Davie,
Deerfield Beach, Delray Beach, Fort Lauderdale, Hialeah, Hollywood,
Jupiter, Lake Worth, Miramar, Miami, Oakland Park, Palm Beach, Palm
Beach Gardens, Palm Springs, Pompano Beach, and Rivera Beach
Broward County • Miami-Dade County • Palm Beach
County
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