An
Open Letter to GlaxoSmithKline (GSK)
Re: Urging GlaxoSmithKline to provide timely patient access to
Bexxar
In a letter to health care providers,
GlaxoSmithKline announced
that it will make Bexxar available only a predetermined schedule
and not available to ship "on-demand."
Dear Sirs and
Madams:
My spouse is now six
years without evidence of lymphoma, because of the Bexxar protocol,
which she received eight years after her diagnosis … and following
many rounds of chemo that led to short-lived responses, the longest
-- her first treatment with CHOP in 1997 -- lasting only six months.
I am also a
representative of the patient community, with a sincere appreciation
for evidence-based standards and awareness that substantial data
strongly suggests that Bexxar can be a vital therapy for others as
well.
Here we explain why
we feel that GSK must continue to provide Bexxar on demand:
1) The
policy change would require many weeks or months to fill orders for
Bexxar. The delay will force most patients -- in need of treatment
-- to use other therapies. Thus, it is a policy that guarantees
that usage of Bexxar will decline further, and along with it the
rationale to retain it at all.
2) Bexxar
has the strongest data suggesting the potential to cure the
indolent lymphomas, which are rarely cured with standard therapy.
Here are a few of the studies with an emphasis on the impressive
durations of responses (four references below).
3) Because
Bexxar uses a type II antibody it is scientifically plausible that
it could be more effective than Zevalin (which uses the Rituxan
antibody) when treating Rituxan-refractory lymphoma, which is
supported by non-comparative (and therefore admittedly limited) data
showing twice the response rate in the Bexxar study for
Rituxan-refractory population according to a recent discussion by
Dr. Mark Kaminski.
4) Patients
who would benefit from Bexxar should not be penalized for market
factors –- such as a financial interest among treating physicians
that does not favor prescribing Bexxar -- which would often require
sending their patients to another physician.
5) Patients
who would benefit from Bexxar should not be penalized because Bexxar
has not yet been marketed adequately, or because an insufficient
number of physicians are trained to administer it.
6) While
companies have a responsibility to their shareholders to reduce
costs, there is also an ethical responsibility to stand by the
patients who have made possible the approval of the drug – and in
whose interest patent exclusivity is provided by society; and when a
company drops a proven drug for marginal reasons it dishonors the
patients who have had made personal sacrifices to help it win
marketing approval by participating in clinical trials.
Further, we note that some uses of this drug under study is its role
as part of induction therapy for stem cell transplant … so it seems
also a patient safety concern as the timing of the Bexxar
component could be critical in this and other investigational
clinical settings.
7) By
maintaining on-demand access to Bexxar GSK has an opportunity to
show it is committed to meeting the needs of patients, even if usage
is not yet sufficient to be profitable. By maintaining on-demand
access to Bexxar GSK can remind us all that there is a need to fix a
system that appears to favor non-curative and financially
unsustainable maintenance approaches to treating what could well be
a medical condition that can be cured with one week of therapy.
In closing, we urge GSK to
maintain full access to Bexxar because it’s the right thing to do
and because there is substantial evidence supporting the curative
potential of this unique therapy. Your company has an opportunity to
show that you also identify with the plight of patients – that you
are aware that we are all future patients and that providing access
to Bexxar is a smart investment in our shared future.
REFERENCES
Bexxar has the strongest data
suggesting the potential to cure
Return to letter
A) CVP followed by Bexxar in
untreated low-grade follicular lymphoma
http://bit.ly/chKTgk
After a median follow-up of 8.4 years, the median
response duration had not been reached
(range, 3 to 111+ months).
B) Phase II trial of CHOP
chemotherapy followed by Bexxar for previously untreated
follicular NHL: five-year follow-up.
http://bit.ly/cng3S8
After a median
follow-up time of 5.1 years, the estimated 5-year overall
survival (OS) rate was 87%, and the progression-free survival (PFS)
rate was 67%.
C)
Bexxar produces durable
complete remissions in a subset of heavily pretreated patients
with low-grade and transformed NHL
http://bit.ly/aVG9WB
“Eighty-one (32%) of 250 patients had a time to progression of >
or = 1 year (termed durable response population). For the
durable response population, 44% had not progressed at > or =
2.5 to > or = 9.5 years and had a median duration of
response of 45.8 months.”
D) Bexxar Therapy as Initial
Treatment for Follicular Lymphoma
http://bit.ly/ct9i9b
“CONCLUSIONS A
single one-week course of 131I-tositumomab therapy as initial
treatment can induce prolonged clinical and molecular remissions
in patients with advanced follicular lymphoma.”
And a follow up report from
the GSK website:
Eight-year
long-term data demonstrate prolonged overall survival and length
of disease remission with BEXXAR
http://www.gsk.com/media/pressreleases/2007/2007_06_04_GSK1056.htm
“Patients who received a single
one-week treatment of BEXXAR as mono-therapy achieved estimated
8-year and 10-year overall survival (OS) rates of 86%.
Additionally, 50% of patients survived without progression of
disease at 8 years following therapy. For patients who
achieved complete remission, the median time before their
disease progressed was 9.2 years. An overall response rate
and complete remission rate of 95% and 75%, respectively, were
observed.”
