Thursday, April 12, 2007

Stem Cell Autoimmune Cures

Stem cells are in the news lately what with the Senate passing a new stem cell bill that President Bush has vowed to veto without reading. Also their have been news reports of stem cell cures for autoimmune diabetes in Brazil and Israel.

Stem cell cures are very emotional subject for me. If President Bush had allowed for unlimited stem cell research and funding in 2001, I feel like my son might never have had to be crippled. I might be healthy enough to work again.

I am a fifth generation Republican. My great, great grandparents and great grand parents were prominent abolitionists who helped to establish the party. I voted for Bush the elder twice. But that was the last time I voted Republican. If I survive my current bad bout with my disease and live fifty more years, I doubt I will ever find a reason to vote for my party again. I feel too much angry. My son has gone through too much agony.

I also spent more than twenty years as a Sunday School teacher, Board of Christian Life Member (Sunday School Board), and Christian Scouting director (Caravans). I have been a member of the Escondido Reformed Church, the Porterville Church of the Nazarene, and the Community Church of Vista (Christian and Missionary Alliance).

But even if I were well enough, I do not know if ever would want to be a member of a church again. I would not even have put up Christmas lights last December except Paul wanted to see them. The take over of our churches, by the angry and hate filled Christians who promote ignorance and misinformation instead of Christ's message of forgivenss, tolerance and love, has left a bad taste in my mouth. These “little god” Christians who would deny cures for the sick and call it compassion, what horrible people they have become. What a terrible image they have given to Christians in this country. Jesus weeps.

Today I called a local radio station, KLSD, the hosts there were talking about the issue. I wanted to give them a personal story of the horror of a disease that might now be cured if Al Gore had take office instead of George W. Bush.

One of the hosts talked to me off air, I wrote him the following email in response. I am tired andvery drained from today's bouts of the "big D" and do not have enough energy to post about the many and varied ways stem cell research could help the members of our autoimmune community. Perhaps tomorrow I will feel better.

Here is my letter to KLSD hosts Stacy Taylor and Scooter:

Dear Stacy and Scooter,
Thanks you for discussing stem cell research on the radio today.

And thank you Scooter for talking with me off air. You asked what you could do for us. You even offered money. Thank you for the offer. Your offer was very compassionate, but unless I had enough money to fund the research that is needed, money will not help.

You two have a megaphone that those of us who are sick do not have. Use that megaphone to:
(1) promote all forms stem cell research,
(2) answer all the right wing talking points on stem cell research
(3) losen up the tight regulations that the FDA has in place that are slowing revolutionary new cures for people.
(4) advocate for universal health care.

Promote all forms of stem cell research—embryonic, fetal and adult. No matter the stem cell source, cures could be found. The fewer restrictions on research the sooner Star Trek like cures would be available to all.

A word on fetal cell research, my wife miscarried between our two sons. If some of the cells from that child (fetus) could have been used for a cure, we would have donated them. It is compassionate to donate organs, right? Why not fetal cells?

Up to six weeks or so a mammal fetus has no immune system. For some unknown reason this allows fetal cells to be transplanted to any other member of a species with no rejection whatsoever. In fact early mammal fetal cells can be transplanted into virtually any other different mammal species with no rejection.

Researchers at Washington University in St. Louis took primordial kidney tissue from pig fetuses and transferred it into rat abdomens. In the rat abdomen, the tissue developed into tiny rat sized kidneys (made of pig tissue) that filtered the rat’s blood and put out urine. This experiment was done over three years ago! Other similar experiments have been done with other mammal fetal cells as well and even earlier.

Think how many dialysis patients have died in the last three years. How many could have been saved if my middle child’s primordial kidney fetal cells could have been transplanted into those patients! My wife and I would have felt better as well somehow part of our child was still alive. Of course her miscarriage was twenty six years ago, those fetal cells are long gone. But why not use fetal cells from others today who miscarry.

(2) Answer all right wing talking points. Embryonic stem cell research must be done because currently only ESC’s can divide indefinitely. A researcher can grow as many as he/she needs, for as long as he/she needs.

Adult stem cell are genetically limited to as few as seven division and then they are done and they die.

Eventually research on ESCs will yield information on how to get adult stem cells to continue to divide but until the research is done adult stem cell lab work is limited by numbers and by the amount of time a line of adult stem cells can be kept alive.

Another point on adult stem cell research, one of the CON talking points is that there are seventy cures for adult stem cells none for embryonic. The adult stem cell cures they are talking about are mostly bone marrow transplants that happen to have a few blood and immune forming stem cells in and among the bone marrow.

Bone marrow transplants have been done for more than thirty years, only five or six years ago researchers discover that there were a few blood and immune forming stem cells (hematopoietic) in among the rest of the bone marrow. The CONS immediately started mis-labeling bone marrow transplants as adult stem cell cures. The seventy adult stem cures are not new. It is old technology given a new name by the CONS.

The second CON talking point is that ESCs treatments cause cancer. True there have been problems with early experiments with undifferentiated ESC’s but now that researchers have discovered some of the cues for differentiating the ESC’s, the problem is closed to being solved. Besides the idea was never to use ESC directly to cure patients, it was to understand them and their differentiation process. Once the process is well understood, cures using any kind of cell would come.

[The differentiation process takes one fertilized egg cell and makes every tissue and organ in an adult human. Researchers are now at the very beginning of learning how that process works. ESC’s are crucial for understanding it. Star Trek type cures will happen when researchers fully understand it.]

(3) Advocate for the loosening up of FDA regulations
Right now there are forty revolutionary therapies, virtual cures and full blown complete cures for autoimmune disease in mice. Only a couple are currently in human trials.

Each set of human clinical trials is estimated to cost one billion dollars under current FDA guidelines. Due to the cost risk exposure, Big Pharma sets draconian exclusion criteria for clinical trials to try to eliminate the sickest patients.

If they allow all patients to try new therapies, some of the sickest will have adverse reactions or die. Their deaths or reactions must be reported to FDA. The deaths or reactions are counted against the company when they apply for FDA approval to sell the new medicine or therapy. A billion dollars in clinical trials could be lost if too many of the sickest patients die. (Not that they weren’t going to die of their diseases anyway.)

We need Blind Compassionate Use FDA regulations. Negative results for any Compassionate Use patient who failed to qualify for the trial due to exclusion criteria should be blinded. The results should have no bearing on FDA approval process.

(4) Advocate for transferable universal health insurance. When my autoimmune disease worsened, I had to quit work. No work, no medical insurance. There are no private insurance companies that would now insure me with a pre-existing condition. My son was a brilliant student. He worked hard at school. He had scholarships and jobs which fully paid for his first two years in college. He never got in any trouble (not one bad report in his entire scholastic career). Suddenly he is hit with a genetic time bomb. He cannot work. He cannot get health insurance. Medications costs thousands of dollars a month.

If my wife could not work, we would have no insurance whatsoever. How would we pay the $3000 a month for his medications? As it is now, because he is only covered by one parent, we have to pay between $3-5,000 a year more than if I still had health insurance. On top of the forty thousand dollar a year hit we take in the difference between my disability pay and what my working salary would be.

Every year in October when health insurance is renewed we have to worry will he still be covered as a disabled dependent? How much more will “our contribution” to his health care be this year? Every year the rules change unilaterally and we have to “contribute” more.

As far as direct help to family, I may need help from you in putting pressure on a researcher at UCSD Cancer Center, Dr. Thomas J. Kipps. He has access to a medication that holds great promise for autoimmune disease and for some kinds of blood cancers (B cell). The medication is called HuMax CD-20. It targets and kills the B-cells which are a key part of the autoimmune cascade. Eliminate the B cells, the autoimmune disease stops.

There is a danger if I receive the medication. I could die of a hypersensitivity reaction or an infection. But I am turning into a skeleton right now--thirty pounds lost in three months. I cannot stop the weight loss as I cannot eat without severe even life threatening reactions.

I do qualify for his Dr. Kipps clinical trial of HuMax CD-20 for three reasons.
(1) He is using it in a clinical trial for B-cell cancer. In other research centers in the US it is being used for autoimmune disease but not here and not anywhere close.
(2) I have an autoimmune disease that results in severe hypersensitivity reactions (likely caused by B cells). If I took HuMax CD-20 and had a reaction, the company would have to report my reaction. My reaction would count against them during the FDA approval process which could come in about two years.
(3) Even though it is known that B cell reductions can stop virtually any autoimmune diseases- (MS, RA, Lupus, et. al.), not all eighty autoimmune diseases have been tried with B cell reduction. No researcher wants to be the first one.

Right now I am trying an oral tolerance therapy to try to get my immune system to accept eight more kinds of food. If it works, I can stop my immediate problem of weight loss.

My immune system is presently causing me to have nearly constant stomach flu and poison ivy type symptoms. Food tastes wonderful in my mouth and swallowing but once it hits the stomach and especially the intestines, I become really ill.

My immune system is either “blind” to the difference between harmless and harmful or it is locked in “super high on” mode.

It is my B cells who are mis-remembering the harmless foods as harmful. The B cells are sending out the signals and antibodies which cause the rest of my immune system to attack my gut when I eat. But if oral tolerance works, I can buy some more time. If not, I need access to HuMax CD20 or other similar medication in clinical trials.

Hu-Max CD20 is a fully human monoclonal that destroys all B cells. It is superior to the only current approved monoclonal (Rituxan) that destroys B cell. Rituxan is more than half mouse protein. Even patients who have never had adverse reactions to any other medication are having extremely serious reactions to Rituxan because mouse protein is easily recognized as foreign by the human immune system.

My son and I have a history of adverse reactions. Our chances with Rituxan would be poor at best. Even HuMax CD20 has a good potential to kill me. The older a person is the more memory B cells. My 24 year old son would have a much better chance. But I must try it first to make sure that a person with our adverse reaction genetics could take it. We cannot try my son first. He is already suffering too much.

Sorry for the length of this letter. You probably can only help with the first four general ways. If you kept talking about those first four on the radio, that will at least give me hope that help might come eventually for my son. If you feel you can help with the HuMax CD20, I can give you contact information for Dr. Kipps.

I am not sure how you could help on getting HuMax CD20 except to broadcast how difficult it is to get new therapies.

Thanks for listening
Peter Welch <>

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