To the right is a picture of Paul's computer keyboard with a layer of three year old dust. He has not been able to use it at all in that time.
Once he was on the keyboard whenever he was home. Sending instant messages and emails to his friends. Getting articles ready as a reporter for his college newspaper and later as editor having to put together newspapers. Now the keyboard is unused.
Yet I am convinced that if he were allowed access to medications now in human trials, he could again use this key board and get back to the life he deserves.
How do I get access for him?
There are only two medications that I would like for him and heck for me, too. They are Ustekinumab and Prochymal.
Ustekinumab, made by Centocor division of Johnson and Johnson, blocks two inflammatory cytokines that genetic tests have identified as THE specific psoriasis cytokines that are out of control made by gene variants called SNP found in psoriasis patients. (See Psoriasis Foundation homepage). The FDA has held up approval for this medication for TWO FULL YEARS after "stunning results" were found in the phase II clinical trial results released in February of 2007.
Prochymal is a mixture of adult immune system precursor cells from a large number of donors that permanently turns off Graft versus Host disease and Crohn's disease in as little as two weeks. This mixture of cell produce the right amounts of the regulating and "off button" cytokines that immune system dysfunction patients are missing.
Paul needs IL-23 and IL-12 regulated as well as his tendency to have out of control allergic and adverse reactions to foods, drugs, pollen, insect bites, etc. Some of the regulating cytokines that are likely in short supply are IL-10 and possibly others.
The immune system precursor cells in Prochymal have the ability to give this regulatory control back to his immune system. Not only could the out of control psoriasis causing cytokines be turned off but the missing immune signal that turns off out of control anaphylatic allergy responses would be made as well.
Two weeks after an infusion Paul easily might have no psoriasis, no psoriatic arthritis, no ankylosing spondylitis and no chance for anaphylaxis hives breathing problems syncope and sudden death. All of those horrors gone if Paul could get access. But no he is denied.
I have Paul's second problem as well. I have had the "fun" of going down the "tunnel of death" several times due to these out of control anaphylaxis reactions. I can tell you step by step the various "joys" of dying of suffocation. Trust me those death row inmates who are killed by IV infusion do suffer. You may not see it because their body's are paralyzed first, but inside their brains they are screaming in agony. It feels so great I am really looking forward to the next time it happens to me--NOT!
All Paul and I need are some of those Prochymal cells (via infusion) and we are cured.
A bone marrow transplant (more accurately called an immune system transplant) would cure both of us as well, except the death rate for bone marrow/immune system transplants remains around 25%. Of the 75% who survive about half never get a fully functioning immune system back. Their old bone marrow/immune system was destroyed by chemicals and radiation before the new bone marrow/immune cells were given in order to make room for the new bone marrow/immune system to grow. Sadly the new implanted one immune system often does not fully 'reconstitute' into a complete immune system, thus leaving the patient forever after vulnerable to various infections.
Paul and I cannot get access to either Ustekinumab or Prochymal no matter how much money we are willing to pay for the treatment. (Unless, of course, I have several million dollars to invest to buy stock or probably easier invest in bribes to those who hold samples.)
Of well, I will be a good little American and sit and watch my son suffer for more and more months, a prisoner of pain in his own body. That is America. The cure sits in the labs for years while the FDA bureaucrats delay approval and make the paperwork and financial burden of clinical trials ever more onerous. The most important criterion for our FDA friends is to insulate themselves from any chance that some error in paperwork could affect their lucrative jobs. The suffering of people like my son is of no concern.
So I will do my job and say nothing.