Make Bexxar Accessible! petition UPDATE:

After submitting the petition to GSK, the VP to whom it was sent responded with the suggestion that we have a conference call.  On it were four GSK representatives, and from the lymphoma community, Dr. Mark Kaminski, co-developer of Bexxar, Karl Schwartz, President of Patients Against Lymphoma (PAL), Liz McMillian, PAL's Facebook guru, and myself.  Following is Karl's summary which he has posted to lymphoma forums and I share here.  We will continue to monitor this situation and do what we can to make certain that Bexxar remains a viable option for patients. 

We felt that the meeting was productive in that we received no "push back" on our concerns ... That is, we felt that our concerns were listened to and considered valid, which were:

1) That the policy change will delay use of Bexxar up to a month - depending on if the need for the drug arises during distribution periods within the month. We noted that experts share our expectation and concern: that usage of Bexxar will decrease further - and that the following expert remark is widely held:
"So yes it will reduce use since some pts whose schedule doesn't fit will have to get something else."
... And that trial enrollment will also slow down as centers will not be able to treat as many patients per month in the Bexxar-based protocols (this was confirmed by a contact at Fred Hutch)
2) That decreased patient access to Bexxar because of a new policy - along with the perception of difficulties in getting access - will contribute further to decreased usage of Bexxar - leading to a downward spiral – leading to the extinction of a vital drug.
3) That Bexxar has not been marketed sufficiently, ever.
We disagreed that FDA is the reason for GSK's inability to market Bexxar sufficiently, citing that there is no regulation prohibiting distribution of journal reports - even for off-label use.

I offered to assist GSK in these matters at FDA.
4) That Bexxar is a unique drug - in that it has the longest follow up data and that all of the data strongly and consistently suggests curative potential, even if no one study proves this definitively.
5) That patients expect GSK to recommit to Bexxar by studying it further, by marketing it appropriately, by pressing for reimbursement reform, and by training more physicians in its administration.
Betsy offered to assist in helping with reimbursement reform at CMS, and asked that GSK provide experts to educate patients about the drug at education forums.
Liz made it plain that oncologists, investigators, and patients were not adequately consulted about the policy change - at least the experts we consulted in this matter.
Dr. Kaminski provided many expert perspectives, such as on the outcome data, and remarked that even the thought leaders in the lymphoma community are failing to recognize the importance of it - particularly when you consider the length of the follow up - 10 years and more.
So what's next?
We will follow up with GSK and ask that they answer our concerns and provide evidence of a change in policy and marketing commitment.
We cannot force a corporation to maintain a drug that is losing money, but we can show GSK that there will be a public relations price to pay for giving up on a unique and vital drug too soon - one that patients helped to bring to the clinic by participation in clinical trials.
(Drugs, unlike cars and toothpaste products, can provide unique societal benefits and require not just financial risks by shareholders - but also require that individuals take substantial risks when the drug is administered into our veins when studied.)
Will that be enough to change corporate policy? We don't know.
All the best,

Karl Schwartz
President Patients Against Lymphoma
www.lymphomation.org

Karl's open letter to GSK sent with petition:
http://www.facebook.com/notes.php?drafts&id=1379719365#!/note.php?note_id=497928551998