Judi Lifton had no idea what she was getting into when she tried to get compassionate use of AMN107 for her partner, Leland Emerson. He could not qualify for the trial as he had already taken Gleevec, Sutent and AMG706. Being ever the vigilant caregiver, Judi began the process which would end up consuming all of her time and possibly her sanity.
There are four required parts to obtaining AMN107 via “compassionate use”: the doctor application, the clinical trial agreement (CTA), the Institutional Review Board (IRB) approval, and the patient and doctor signature.
The actual story is a long and complicated one that would make your head spin. However, here are the highlights of what was almost a tragedy.
The first problem Judi encountered was going to a satellite location of a downtown cancer center. They were unable to handle such a task and put the burden on Judi. The downtown center was used to dealing with standard clinical trials. In this case two IRBs were needed (for both the downtown and satellite offices), once again the burden was on Judi.
The CTA is sent out to the hospital at the same time as the doctor applies but in this unfortunate case, the CTA fell through the cracks. No one can be sure how this happened, but it did. The downtown office should have been aware of the procedure.
When the CTA was finally addressed by the center properly, the satellite center refused to do it; Judi and Lee were forced to go to the downtown center. More roadblocks would soon emerge when the cancer center’s lawyers began objecting unnecessarily to parts of the contract.
It is at this point that Judi pulls out all of the stops and writes a very frustrated email (below) to her personal contacts within the cancer center (who she had kept apprised of the situation), asking for their help.
Dear Team,
Have continued to work on Lee’s predicament in obtaining AMN 107. Called Novartis late Friday for an explanation of why this is taking so long. Their answer was that the contract committee couldn’t respond to the changes we made on the agreement. (They handle most changes.) So they called in their attorneys. They still haven’t resolved it. What a quandary…. My mind can only recall 3 other members in the cancer group who have died waiting for this drug because of the red tape with their institutions. The one person who received the drug quickly (in a few weeks) was someone from a small town. Novartis sent a rep out. Everybody immediately signed everything. Obviously they were naive. Obviously, we are not. I was hoping there wouldn’t be a stalemate. At some point I would like to be on a committee that develops a system for emergency expeditiousness. Apparently there is not one in place. It saddens me. It has been almost two months. It is one patient who will sign documents saying the hospital is not liable. It is not 50 patients in a trial. Now there is money involved…how much? Could we plan future fundraising to expedite this? Call the news media and our families to raise money? Have a marathon? There must be patrons that have donated money for patient advocacy. One of Lee’s previous employers has grants for things like this but it will take time: we don’t have it.
Can this be solved in this week? I leave it to you.
My hands are tied… Judi
Thankfully, Judi’s contacts breathed down the necks of those stalling the process and Lee was finally able to get AMN107 in October, after a long and grueling struggle.
“You need an advocate, a contact at the hospital and a contact with Novartis that’s willing to work with you.” Judi says, “I would not have been able to do it without the help of Novartis.”
