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.”
