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Senior Citizen Politics
Drug Company Wants to Force $2,000 Cancer Drug to
Replace $40 Avastin
Sen. Kohl demands info on Genentech move that could
cost Medicare $3 billion annually for treating of macular degeneration
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Battle is over
treatment for macular degeneration |
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Nov. 29, 2007 – Sen. Herb Kohl (D-WI) stepped to
the front of the line late yesterday to intervene in a proposed limit by
Genentech in the availability of its cancer drug Avastin to certain
pharmaceutical compounding firms and pharmacies. Some physicians have
charged that Genentech’s intention in limiting Avastin’s availability is
to boost sales of Lucentis, a chemically-similar, yet far more expensive
drug also produced by Genentech.
Genentech officials are considering a plan under
which wholesalers no longer would distribute Avastin to compounding
pharmacies, which divide vials of the medication into small portions for
use in the eye for Macular Degeneration, the primary cause of blindness
in senior citizens.
Genentech also manufactures the similar drug
Lucentis, which
FDA last year approved as a treatment for the eye disease.
Sen. Kohl made public copies of letters he has sent
to Centers for Medicare and Medicaid Services (CMS) Acting Administrator
Kerry Weems, Food and Drug Administration Commissioner Andrew von
Eschenbach, and Genentech, Inc.’s President of Product Development Susan
Desmond-Hellman concerning Genentech’s proposed plan.
Of major concern to Kohl is the potential cost to
taxpayers. He cited an October 12 Wall Street Journal article, entitled
“Genentech
to Limit Avastin Availability, Use of Cancer Treatment For Eye Ailment
Hurts Sales of Targeted Drug,” which stated that because
Medicare is a large purchaser of Avastin, the cost to taxpayers could be
as high as $1 to $3 billion dollars a year if availability of the drug
is curbed.
“Any instance that could cost taxpayers potentially
one to three billion dollars is of great concern to me,” said Chairman
Kohl in the letters.
“I take very seriously the [Aging] Committee’s
responsibility to protect and advocate on behalf of our nation’s
seniors. Part of this responsibility is ensuring that seniors are
receiving appropriate and cost-effective prescriptions drugs.”
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About Lucentis
Drug Treatment Slows Macular Vision Loss in
Diabetics
Inspired by ranibuzumab (Lucentis) slowing vision
loss in people with macular degeneration
December
15, 2006 - Encouraged by the effect of the drug ranibuzumab (Lucentis)
to slow the loss of central vision in people with macular degeneration,
John Hopkins Wilmer Eye Institute scientists injected the drug into the
eyes of 10 people losing their sight from macular edema and saw promise
in its ability to stem a common precursor of blindness in diabetics,
which involves the same central light-sensitive area of the retina (the
sensitive area at the back of the eye).
Read more...
Top 10 Stories of 2006 by Harvard Health Letter
Picks Key Ones for Senior Citizens
Lucentis for macular
degeneration, Zostavax for shingles make list
December 4, 2006 - The editors of the Harvard
Health Letter, and doctors on its editorial board, have chosen the top
10 health stories of 2006. Their number one choice – the HPV vaccine to
guard against cervical cancer – is a great development but not
necessarily a senior citizen issue. The first clearly important issue
for older Americans on their list is number four - the FDA approval of
Lucentis as a drug to prevent wet macular degeneration, the leading
cause of blindness in seniors. Another key senior issue is number six -
the approval of Zostavax, the first vaccine against shingles.
Read more...
Lucentis Therapy for Wet Age-Related Macular
Degeneration Shows Significant Vision Gain
'Lucentis is most
significant advance in treating AMD in history'
October 10, 2006 -More than one-third of patients
treated with Lucentis for wet age-related macular degeneration (AMD)
showed "unprecedented improvements" in vision, according to findings
published in the New England Journal of Medicine. AMD is a major cause
of central visual loss and is the leading cause of blindness in senior
citizens.
Read more...
FDA Approves Lucentis for Treatment of Wet
Age-Related Macular Degeneration
Monthly dose can maintain the vision of more than
90% of patients
July 2, 2006
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According to the Wall Street Journal, Avastin will
only be available to hospital pharmacies and directly to doctors as of
January 1, 2008.
After that date, compounding pharmacies will no
longer be able to obtain the drug and repackage for the treatment of eye
diseases. A once-monthly dose of Avastin from these pharmacies costs
roughly $40; a comparable dose of Lucentis costs approximately $2,000.
Genentech issued a statement saying it intends to
cooperate with Sen. Kohl's request for information and work closely with
committee staff to answer their questions.
Earlier this year, at an
Aging Committee hearing examining the pharmaceutical industry’s
influence on physicians and their prescribing behaviors, an
ophthalmologic surgeon representing Physicians for Clinical
Responsibility (PCR) testified before the committee.
In interviews with committee staff previous to the
hearing, the physician shared troubling, detailed information regarding
Genentech’s refusal to cooperate with or furnish drugs for a comparative
clinical trial on the effectiveness of using Avastin to combat many
serious eye ailments, including wet macular degeneration, many of which
occur primarily in the elderly.
As a result of this investigation, Chairman Kohl is
working on legislation that would give CMS the authority to waive
co-payments for patients participating in government-funded clinical
trials and comparative-effectiveness studies.
Links to letters:
October 18, 2007 Letter to CMS Acting Administrator Kerry Weems
November 7, 2007 Letter to FDA Commissioner Andrew von Eschenbach
November 14, 2007 Letter to FDA Commissioner Andrew von Eschenbach
November 16, 2007 Letter to Genentech, Inc. President of Product
Development Susan Desmond-Hellman
Other Coverage
Senator Criticizes Limits on Sales of Genentech's
Avastin
Genentech's plan to limit the availability of cancer drug Avastin,
which would require physicians to use a more expensive version of the
drug called Lucentis to treat wet age-related macular degeneration, will
cost taxpayers $1 billion to $3 billion annually, according to Sen. Herb
Kohl (D-Wis.),
Bloomberg/New York Times reports (Bloomberg/New York Times, 11/29).
Genentech officials are considering a plan under
which wholesalers no longer would distribute Avastin to compounding
pharmacies, which divide vials of the medication into small portions for
use in the eye. Genentech also manufactures the similar drug Lucentis,
which
FDA last year approved as a treatment for the eye disease, the most
common cause of blindness in the elderly.
Both Avastin and Lucentis block the growth of blood
vessels. Lucentis costs $1,950 per dose, about 100 times more than the
cost of the dose of Avastin required to treat the eye disease.
In letters to
CMS and FDA that were made public on Wednesday, Kohl wrote the
company's decision "is of great concern to me." Kohl also wrote a letter
to Genentech informing them of a future investigation by his staff of
the Avastin restrictions.
In a statement, Genentech said, "The request is a
voluntary request for information," adding, "Genentech intends to
cooperate with Sen. Kohl's request for information and work closely with
committee staff to answer their questions."
According to the
Contra Costa Times, some have requested that Genentech conduct a
study comparing the two drugs, but it has no plans to do so. Company
spokesperson Krysta Pellegrino said, "For Genentech, we think our
resources would be better spent to continue to do research in unmet
patient needs." She added, "We believe that we've already shown that
Lucentis is the right treatment for this eye disease" (Morrill, Contra
Costa Times, 11/29). The
National Eye Institute is financing a two-year study comparing the
effectiveness of the two treatments (Kaiser
Daily Health Policy Report, 10/6/06).
Bevacizumab (Avastin) for
Treatment of Solid Tumors
Bevacizumab (Avastin) was the first U.S. Food and
Drug Administration (FDA)-approved biological therapy designed to
inhibit the formation of new blood vessels to tumors. It is manufactured
by Genentech, South San Francisco, Calif.
Tumor cells require a constant supply of blood to
receive the oxygen and nutrients they need to survive. As a tumor grows,
it signals the need for more blood by secreting growth factors that
trigger the formation of new blood vessels, a process called
angiogenesis. Of the many growth factors implicated in the formation of
new blood vessels, vascular endothelial growth factor (VEGF) has been
identified as one of the most potent protein supporting tumor growth. In
addition to affecting tumor growth, VEGF promotes formation of new
capillaries surrounding the tumor, providing increased nutrients for
growth and a convenient route for tumor cells to spread throughout the
body.
Bevacizumab was developed to inhibit VEGF. It was
designed to cause the destruction of the blood vessel networks that feed
cancer cells as the lack of a constant source of blood may slow tumor
growth. Bevacizumab is an antibody -- a type of targeting device
produced by the immune system that can locate and bind to a specific
protein. In the case of bevacizumab, it is a monoclonal (cells derived
from a single common ancestor) antibody that binds to and inhibits VEGF.
From an article by National Cancer Institute
appearing in SeniorJournal.com on July 5, 2006.
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