Paul Update, Stem Cell Cure Closer, Why Rituxan Works, Peanut Allergy Cure? FDA Bureaucrat's Survival Motto

PAUL UPDATE

My son, Paul. who has psoriasis, psoriatic arthritis and ankylosing spondylitis continues to show modest improvements with infusions of Remicade (infliximab). Yesterday he showed me he could rotate his right wrist from inward to outward fairly rapidly. The motion is what is need to throw a Frisbee. Its the first time he could make that motion in about three years. Also yesterday while watching a comedy on TV he laughed out loud with the characteristic belly laugh my wife and I heard when he was young before the autoimmune horror attacked his vocal cords. It is the first time I have heard that laugh in years. I never thought I would hear it again.

I am grateful for the two extra years of life that Remicade and Imuran have given him since the undiagnosed AS almost suffocated him on the night of our 32 wedding anniversary, July 5 2007. His rheumatologist at that time had missed the AS diagnosis. His ribcage had become so inflammed that he could not expand or contract it. We had taken him to the rheumy a couple of days before, she felt that he was being wimpy and that rudely lecturing and belittling him would get him breathing better again. Needless to say we have a new rheumatologist, Dr. Roy Kaplan of Encinitas California who made the correct diagnosis and saved Paul's life with the help of cortisone shots, Remicade and Imuran.

Yet the Remicade infusions still scare the heck out of me. They are made from mouse cells and are full of mouse proteins. Paul has a history of food and drug reactions including syncope, swelling of lips (angioedema) and hives (urticaria). Putting animal proteins in his body seem to me to be a terrible risk for someone with so many allergies and reactions to foods and drugs.

Centocor that makes Remicade has a fully human version of the drug called Golimumab in clinical trials that have now gone on for more than three years. The FDA bureaucrats are holding up Golimumab with demands for clinical trials way beyond what is necessary to show safety and efficacy. So Golimumab, a FULLY HUMAN, far safer medication that blocks TNF alpha just like Remicade sits in clinical trials and my son and others who need it are denied access. It seems to me that the FDA would want to speed approval of this better safer version of Remicade to a matter of weeks or months, not delay it for years.

Paul's next Remicade infusion is this Friday. The process will take three hours. The first hour for infusions of steroids and antihistamines in an attempt to fight an immune reaction to the mouse proteins in Remicade. Then the Remicade is slowly dripped in to his blood stream. Whole body fatal anaphylatic reactions have been documented in patients with a history of allergy for days to weeks after the infusion. Every six weeks I live in fear for my son. So hard.

STEM CELL AUTOIMMUNE CURE IS EVEN CLOSER

As you may know Prochymal by Osiris Pharmaceutical is a stem cell product which has had phenomenal success in "curing" Crohn's disease and stopping transplanted bone marrows from attacking and killing (dissolving)the host the marrow is transplanted into.

Our bone marrow makes our complete immune system. Bone marrow transplants cure autoimmune disease when the patient survives the post transplant window (a few months)of weakened immune response and the potential attack of that new immune system on the patient's tissues.

This attack is called Graft versus Host Disease (GvHD). It is not a pleasant way to die. The attack is something like having every autoimmune disease at the same time. If GvHD can be stopped than autoimmune disease can be stopped.

Prochymal is THE FIRST treatment ever to completely eliminate GvHD without harming the immune system's response to pathogens. All previous treatments used immune suppressant agents like cyclosporine, CellCept, cyclophosphamine, tacrolimus and others (sometimes Rituxan even!) to stop the attack. All the immune suppressants only slow down the attack. They do not cure it. Prochymals unique blend of stem cells appears to eliminate (dare we say cure?) the problem of GvHD completely.

The exciting news in this area is that a mechanism for why Prochymal works has been discovered. Somehow certain foreign immune cells stimulate the production of T regulatory cells. These T regs turn down or even turn off maladapted autoimmune responses and also turn off GvHD. Apparently all placental mammals have this mechanism. It is the process that allows a fetus to remain in utero safely without the fetus' immune system attacking the mother's cells and the mother's immune system from attacking the fetus.

We have known for two decades that every mother retains living cells of each of her children in her body for decades after her children are born and that the children retain some of their mother's distinct cells decades after birth. In one case in a man with type I diabetes, pancreatic cells with his mother's genetic signature were found to be producing insulin and preventing him from manifesting severe symptoms of the disease.

Since the fetus and the mother are genetically different, their two immune system should recognize the other as foreign and attack each other. That does not happen and now we know why and it points toward the real possibility of a stem cell cure for all of us in the not too distant future. Tomorrow if the F'ing DelAy would allow clinical trial rules to be relaxed, a decade from now if we do not push for changes hard enough. Either way autoimmune disease is going to be "cured". Stem cells will be definitely be one avenue for the "cure" (Editorial note: Good riddance George W. Bush and the Republican anti-science US Congress)

Read the New York Times article here:
http://www.nytimes.com/2009/02/03/health/research/03immu.html?ref=science


HOW RITUXAN ENDS AUTOIMMUNE DISEASE

It turns out that Rituxan (Rituximab), which kills B cells by attaching to CD 20 receptors, preferentially attacks autoimmune causing B cells. That's right Rituxan kills the "bad" autoimmune causing B cells more than the "good" B cells that give us immunity to childhood and other diseases. The "bad" B cells are the cells that make the auto-antibodies which are responsible for initiating the attack on our body's tissues.
See: http://www.medicalnewstoday.com/articles/117158.php

These auto-antibodies label tissues for attack and keep the autoimmune pot boiling. When the auto antibodies are eliminated the autoimmune process ends. B cells make antibodies. Eliminate the B cells and the autoimmune process stops. This process of elimination is called B cell depletion. Rituxan is the only approved medication for B cell depletion. Now it turns out that Rituxan is better than expected at SELECTIVELY eliminating the "bad "autoimmune causing B cells. Whoopee! Let's here it for serendipity!

Without B cell cancers (non Hodgkins lymphoma, etc.) Rituxan would never have been developed. Then a patient with both B cell cancer AND an autoimmune disease (RA) was put into remission for BOTH by repeated infusions of Rituxan. Now it turns out that Rituxan is even better than thought at selectively eliminating the really bad actively antibody producing B cells that are main cause of autoimmune disease. Yeah!!! Read: http://www.nature.com/ncprheum/journal/v5/n2/full/ncprheum0983.html or http://www.ncbi.nlm.nih.gov/pubmed/19092831

Now all we need is a FULLY HUMAN version of Rituxan. The current version is a MOUSE protein version. There can be really bad reactions to the mouse proteins. Although RITUXAN is the ONLY MEDICATION where additional exposure to the medication reduces adverse reactions.

PEANUT ALLERGY CURE?

Usually the second(or subsequent) exposure is the fatal one for most fatal drug reactions. Just the opposite happens with Rituxan. The first infusion causes the biggest reaction. Additional infusions have smaller and smaller reactions or no reaction at all. This fact makes it clear that at least some, if not most, adverse reactions to foods and drugs have to do with "bad" B cells making maladapted antibodies. Eliminate the "bad" B cells then the adverse food or drug reaction goes away. If the B cells actively making peanut antibodies were eliminated with Rituxan, shouldn't the peanut allergy be cured?

Do the folks with peanut allergy know this?

WHY FDA BUREAUCRATS ALWAYS FIND A REASON TO NOT APPROVE INVESTIGATIONAL MEDS

Gotta love those FDA bureaucrats. You do know their motto?

"Delay, delay, delay saves my bureaucratic butt for another day.
Never say yes, it's a definite risk.
To make any decision might put me in a position
where my career is mired or worse I could be fired.
Who cares if people die as long as I save my hide."