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Special Report
US ophthalmologists fight
Avastin decision
Sean Henahan
in New Orleans
THE success of anti-VEGF agents,
particularly Avastin (bevacizumab) and
Lucentis (ranibizumab), in the treatment of
AMD and other retinal disorders, is one of
the major stories in the field of
ophthalmology in recent years. The story
got more complicated when Genentech,
maker of both drugs, announced that it
would no longer make Avastin available to
compounding pharmacies in the US,
effectively making it unavailable to
American ophthalmologists.
What are the implications for European
doctors? Not serious at this point. Avastin
is distributed in Europe by the Swiss
pharmaceutical company Roche
Pharmaceuticals, which so far has not
made any moves to restrict
ophthalmologists’ access to the drug.
But American ophthalmologists are very
concerned about the Genentech decision
which they say has serious implications
for patients.
So why did Genentech take this step?
The company claims that it was being
pressured by the US Food and Drug
Administration (FDA) to take action, since
Avastin, a cancer treatment, is not
approved for the treatment of AMD. The
FDA for its part says it did not, and would
not, interfere in how physicians practice
medicine, including using this drug
than just for AMD patients,” said H
Dunbar Hoskins Jr, MD, executive vicepresident of the AAO.
The Genentech move came shortly
before the AAO met in New Orleans for
its annual meeting. The AAO convened a
special session at the conference to bring
the issue before the delegates. The
meeting, filled to capacity, included AAO’s
leadership, Julia Haller MD president of
the American Society of Retinal Specialists,
legal experts, and most interesting of all,
Susan Desmond-Hellmann MD, MPH,
president, product development,
“The AAO decided to take action
because it felt this would severely reduce
access to effective therapy for treatment
of AMD and would stifle the innovation of
physicians in evaluating off-label uses,
which are the genesis of many of the
treatments we have in ophthalmology. It
would also create a significant safety
problem by taking professional pharmacy
drug compounders out of the mix,” noted
Dr Hoskins in his opening remarks.
Chicago ophthalmologist Kirk Packo
MD received a standing ovation following
his critical review of the Avastin situation
and impassioned defence of physician’s
legal right to use drugs off-label.
Dr Packo told the assembly that recent
Genentech decisions had “built up a wall
of distrust” between the company and the
ophthalmic community. He commented
that the most offensive decision was the
“The primary concern of ophthalmologists is preserving
the sight of our patients. Because Avastin has also been
used off-label to treat diabetic retinopathy, macular
oedema and various other sight-threatening disorders,
Genentech’s decision to restrict availability of the drug
has much wider implications than just for AMD patients”
H Dunbar Hoskins Jr, MD
The AAO immediately responded to the
‘Dear Doctor’ letter sent to US
ophthalmologists by Genentech. Other
organisations including the American
Retina Society also voiced protests.
“The primary concern of
ophthalmologists is preserving the sight of
our patients. Because Avastin has also
been used off-label to treat diabetic
retinopathy, macular oedema and various
other sight-threatening disorders,
Genentech’s decision to restrict availability
of the drug has much wider implications
letter the company sent direct to patients
suggesting that Avastin was not a good
Dr Packo ended his presentation saying:
“Dr Desmond, tear down this wall!”
Then Dr Desmond-Hellmann had her
chance to address the capacity crowd. She
cited FDA concerns related to the sterility
and repackaging of Avastin for ocular use.
She emphasised that Avastin was not
designed, manufactured or approved for
this ophthalmic use. She then explained
that the company had taken its decision
by Sean Henahan
The Comparison of AMD Treatments Trial (CATT) now under way was designed to compare the efficacy
of two anti-VEGF agents, Avastin and Lucentis in newly diagnosed patients with neovascular AMD. The
two-year US National Eye Institute-sponsored study will randomise 1200 patients at 45 sites. Patients
will receive either Avastin or Lucentis on a fixed dosing schedule every four weeks, or Avastin or
Lucentis on an as-needed basis. One-year results are expected in early 2010.
“We are using these drugs and we have no randomised clinical trial data to support what we are doing.
Almost everyone is using the drugs on an as-needed basis rather than via fixed dose. While in the short
term these patients seem to do very well, we are by design, by dosing as needed, allowing patients to
relapse. Many patients may recover, some may not. It is incumbent upon us to understand whether we
are sacrificing long-term visual outcomes with this as-needed dosing vs. fixed dosing. This is one of the
most important aspects of this study,” notes Daniel F Martin MD, professor of ophthalmology, Emory
University, Atlanta, Georgia, US, and director of the CATT study.
[email protected]
on advice of its regulatory advisors
following a three-week inspection of its
Avastin manufacturing facility by the FDA.
Nonetheless, Dr Desmond-Hellman
repeatedly emphasised that Genentech did
not believe its action would put Avastin
out of reach, and that it did not intend to
interfere with the physician-patient
relationship. She reiterated the company
position that Lucentis was approved for
the treatment of AMD, and that her
company would look at ways to improve
access to the drug for those that could
not afford it.
“We’ve heard your concerns. We’ve
heard you when you say you think
Genentech has crossed the line in the
physician-patient relationship. We’ve heard
your financial concerns about Lucentis. We
know you are worried about Avastin
access,” she told the assembly.
The frustration with the current
situation was also palpable at a press
conference that followed the session.
“I am disappointed that Genentech
continues to believe that there is an issue
with the distribution of Avastin to
compounding pharmacies. The way I see it,
the FDA has been very clear in their
public statements that they are aware that
patients are being treated with Avastin offlabel; they are aware that compounding
pharmacies are providing Avastin, yet they
Retail cost/dose
have taken no action. The job of the FDA
is to protect the public. It would seem to
me that if they had concerns and they
know that this activity is affecting
hundreds of thousands of people, that
they would take action. In fact, they have
not taken action. This indicates to me that
at the present time they have no problem
with this. If they have no problem, I don’t
understand why Genentech feels the need
to change their distribution practice.
Parenthetically, the CATT study
(Comparison of AMD Treatments Trial)
researchers had to obtain an IND
approval, from the FDA. It seems to me
inconsistent that the FDA would provide
an IND if they were concerned about the
use of Avastin,” commented George
Williams MD, Beaumont Eye Institute,
Royal Oak, Michigan.
[email protected]
[email protected]
For more information please visit these links:
Dear Doctor letter
Avastin-Lucentis comparison trial
Special Report by EuroTimes Nick Lane PhD