Saturday, March 31, 2007

Australian "Instant" Mouse Autoimmune Cure

The following is a post from last January 11. I was unable to post it at the time as I am a computer cretin and blended two blogs into one ending my access to Autoimmune Digest my original blog.

The information is still good however. This is a therapy that promises to be so good as to act as a virtual cure. But no one in the autoimmune community will get it for decades. Then it will be one of the Big Four autoimmune disease that get it first-- RA, MS, juvenile diabetes or Lupus. The rest of us, with the other 80 autoimmune diseases, will get it decades after that. Completely unacceptable! Be angry!

Imagine an AIDS treatment that had the potential to be a virtual cure. Do you thing the AIDS community would sit back and allow the FDA to require thirty years of testing before humans could use it? There would be rioting in the streets. Why do we sit suffer wait and die?

I know a "good" patient is not suppose to complain. Physicians, researchers, FDA and Big Pharma all say to us, “Sit in the corner. Don’t bother us important people. Goodness knows if we allowed mouse cures for people in months rather than decades someone might be harmed even die.” As if we are not dying now. How many online friends have you lost already? I have lost a bunch in the last five years. We are dying and no one gives a (deleted).

In the eighties new therapies were being given to AIDS patients within months of their discovery. The only hold up was scaling up the production of the new medication. I can name a half dozen or more autoimmune therapies from the 70’, 80’s and 90’s that still are not being used on humans. Damn I wish my son could be redefined as a mouse. Maybe he could have his cure then.

Here’s my "lost post" from last January. Mouse Cure #38

Exciting news from Australia--Charles Mackay of the Garvan Institute of Medical Research has announced a treatment for all inflammatory diseases. Conditions that could be helped range from the eighty plus named autoimmune “diseases” to atopy (asthma, allergy, eczema) to atherosclerosis to sepsis.

Using a hybrid mouse of his creation which contains a gene linked to inflammatory (autoimmune) arthritis, Mackay stopped and even reversed the disease. By my count this is Mouse Cure #38. Still no human cures.

Here’s the most amazing part. The palliative (curing) affect was apparent not in weeks or months, but within hours of treatment. Let me repeat in less than a day the swelling in the mouse joints dropped to virtually zero! Quote from MacKay, “ …the inflammation, the redness, the swelling in the joints would drop down to virtually nothing to pre-disease levels within a day. It was really quite phenomenal.”

The drug is a monoclonal antibody for a target for a C5A receptor that causes inflammatory cells to migrate into tissues. I am guessing that the inflammatory cells are T effectors or possibly eosinophils or even macrophages. The article did not say.

Who cares the type of cell? Right? Me either. The announcement indicates hope for an effective, IMMEDIATE, treatment for all autoimmune disease giving relief within hours of administration of the medication.

In the interview MacKay of the Gavan Institute says this treatment could help multiple sclerosis, asthma, sepsis, heart attack, psoriasis, and transplant patients. That list is just the tip of the iceberg. A scattering of diseases were mentioned but the number of diseases and conditions that an anti-inflammation agent like this could help is simply huge. Even heartburn, Crohn’s, and IBS would likely benefit from anti-C5A.

Imagine an asthma medication that could immediately stop and reverse even the most severe asthma attack. Right now some 20 to 30 % of hospitalized asthma patients die. Best current practices and best current medications allow a good fifth of hospitalized asthma patients to die while under close medical supervision in a hospital.

Large numbers of patients die from adverse drug reactions while hospitalized. The last estimate released in a JAMA article indicated approximately 100,000 patients died in 1998 while in US hospitals from drugs they were given. A medication that could stop the out of control inflammatory/allergic response some of us have to medications could save tens of thousands just in the United States alone.

My son who can no longer hold a pen or a fork, who can no longer talk or walk unaided might be able to do all of those things the day after a treatment. It brings tears to my eyes to think of hearing my son’s voice again. To see him turn his head or to see him walk outside again, I would give anything. THE HORROR of his rapid losses has been so fast so overwhelming and so constant, my wife and I have hardly had time to breathe. I have read about so many mouse cures in the last three years, yet still my son sits crippled and in pain. If only he were a mouse.

Downside—The monoclonal anti C5A has not been tested in humans. Humans are missing a significant piece of the anti-autoimmune responses that all other mammals even chimpanzees have. Therefore even when innovative meds cure mice they may harm humans. (Read the case of the elephant man effect on three healthy volunteers who were testing an immune regulating drug in England last year.) Knocking down the immune systems sometimes allows latent viruses to re-emerge with devastating even fatal outcomes. We humans are full of viruses that are suppressed but not completely vanquished examples are herpes, Epstein-Barr (mononucleosis), chicken pox, and most deadly PML (a kind of brain fever that cooks and kills the brain).

Messing with the human immune system is risky business but leaving my son and so many others to rot in horrible pain is not “doing no harm.” The Hippocratic Oath should compel action not prevent it. Too many promising therapies sit on the shelf for years because of the misuse of “do no harm.” Sitting and watching an autoimmune disease continue its daily ravage of a young man’s body certainly is doing harm.

Sadly the anti C5A monoclonal is still a couple of years away from human clinical trials. The trials will use patients for only one autoimmune condition probably Rheumatoid Arthritis because RA affects more people and presents the biggest market and most profits for a drug company.

The trials will take three to five years. If anti-C5A successfully passes he various clinical trial tests of time, money, safety and efficacy, then it will be approved for only the tested condition (again probably RA) even though it will likely help all other autoimmune disease patients.

All autoimmune diseases share the same basic characteristics especially inflammation. Each new approval for a new “different” autoimmune condition will take another three or four years. So if you have psoriasis, this treatment is at best twenty years away. If you have a rarer condition maybe fifty years in the future if ever. Let's here for the wonderful protections clinical trial protocols give us from cures.

Anti-C5A is a monoclonal antibody. There are more side affects with monoclonals especially the ones that are part mouse like Remicade and Rituxan.

It will likely be very expensive. My son’s medication costs over three thousand dollars (US) each month on the open market. Currently my wife’s insurance as a public school teacher covers most of the cost. However each year we are contributing more for that insurance. We could lose coverage at any time.

Only autoimmune medications FDA approved for psoriasis are covered by my wife’s insurance. We can not afford the newest medications approved for RA (orencia, kineret etc. the insurance company says it will not cover them until they get the FDA seal of approval for his particular form of arthritis. Even though all current PsA medications were first RA medications, the insurance company will not pay for the latest RA medications for Paul. He has to wait for the marketing companies for orencia and kineret to come up with a billion dollars minimum for psoriatic arthritis clinical trials.

What can we do to speed the process?
(1) Somehow we have to get the entire autoimmune community together to work toward a common cure. No more separate foundations for psoriasis, MS, Lupus, asthma, etc, etc. Write to the organization that you belong to refer them to this interview and to this blog. Encourage the board of directors to join with other boards. Not just for anti-C5A. It is not the only medication or therapy that could eliminate or cure all auto-immune disease. There are about thirty other successful mouse cures that should be tried on a wide variety of autoimmune and allergy type conditions.

(2) Write to both of your US Senators and your one US Representative. Tell them cures for autoimmune disease and allergy are at hand. All that is needed is money. On September 10th, 2001 there was no money for nation building. President Bush, the younger, said he did not believe in it. Now six years later we have found $500,000,000,000, that is half a trillion dollars to spend on Iraq. If we took what is spent in Iraq in one month and spend it finding cures, my son would be walking a year from now. The cures are that close and that cheap (compared to the Iraq War).

(3) Tell everyone you meet that cures are here for mice. All we need is a little money and there will be a revolution in medical treatments for the 5 to 10% of the world’s population suffering with inflammatory conditions.

(4) Go back and read the preamble to this blog. Principle number one—Any medicine or technique that helps any autoimmune disease is likely to help all autoimmune diseases. Go shout this principle to any and every one you can.

(5) Clinical trials for new marvelous cures should not be confined to one autoimmune disease. As many disease conditions as possible should be included. FDA approval of a medication for one auto immune disease should mean approval and insurance coverage for all autoimmune disease. Write the FDA. Call the FDA. Email the FDA. Make a nuisance of yourself.

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