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.

Friday, March 30, 2007

Guiding Principles

This second post is a summary of the guiding principles I have discovered in my years since childhood as an autoimmune sufferer and now as a parent of a severely and recently disabled 24 year old son. The Guiding Principles of Autoimmune news are:

(1) Any medicine or technique that helps one autoimmune disease has a very good chance of helping most or all other autoimmune diseases e.g. TNF-alpha inhibitors.

(2) All autoimmune disease is bone marrow disease. Fix the bone marrow. Cure the disease.

(3) Treatment options take too long to get to patients

(4) Clinical trials cost the pharmaceutical companies too much money and have too many exclusion criteria for sick patients

(5) Restrictions to access to the latest autoimmune potential cures should be eased for informed and very ill autoimmune patients who have no other options.

(6) The entire autoimmune community should work together. No more separate organizations and separate research. United we stand . Divided we get no cures. Every patient, friend or relative of a patient and all autoimmune organizations should come together immediately to conduct massive campaign to find a universal autoimmune cure. The AIDS community demanded action and funding. It worked. We should not be divided into associations that advocate for only one condition i.e. rheumatoid arthritis, psoriasis, multiple sclerosis, lupus, Type I diabetes, etc.

(7) The medical profession is generally uniformed and inept when treating immune disorders.

(8) A new medical specialty is needed specifically for the treatment of autoimmune disease, atopy (asthma, allergy, eczema),and immune dysfunctions. It should be created and licensed by the American Medical Association.

(9) Better, more accurate medical tests for immune dysfunctions are desperately needed i.e. genetic tests, cytokine screens, family genetic history, and personal genomes.

(10) The laboratory techniques, the equipment and the innovative new ideas are in place for revolutionary cures for autoimmune disease, asthma, allergy, cancer and infectious disease--only funding is lacking.

(11) Every person who is affected either personally or through a family member has the duty to do everything in their power to influence Congress and wealthy donors to fund these potential cures. Right now! No more delays!

Research findings which have potential to have an impact on autoimmune disease will be summarized in this blog. Topics will include cell death (a good thing), cell proliferation (a bad thing), suppression of arms of the immune system (usually good but can also kill patient), destruction of various arms of the immune system (often good but can also kill patient), immune vaccines and various other potential cures.

Personal News for family and friends
Paul had a good day today. He was able to whisper a few words. He heard Margaret come home from shopping. I did not. His hearing is still acute. He was able to indicate that he heard her with two gestures. He "pointed" at her chair and than at the floor. (He cannot really point any more as he cannot make a fist. He kind of sweeps his arm). His gestures spoke volumes. I was now alerted to go to the garage and help her unload the car. He slept only six hours last night--too much neck pain to sleep longer. The tendons in his arms hurt all the time as they are under active attack by his immune system. He is currently trying to nap.

(Maladapted B cells are churning out huge amounts of tendon specific antibodies which find attack and label his tendons as "bad". T effectors (a kind of white blood cell) "see" the antibody labelled tendons and join in the attack. They actually take "bites" out of the tendon. This is exactly the same process that happens in every single autoimmune disease. The only difference is the target of the activated maladapted B cells and their antibodies. The target is myelin for MS, joints for RA, intestines for Crohn's/colitis, etc.)

I seem a bit better today. My intestines do not hurt as much today. No stomach flu symptoms or spasms so far and its almost 4:30 in the afternoon. It is a good day.

By the way for anyone with IBS, IBD, Crohn's, colitis or any other intestinal difficulty, I recommend ordering VSL#3 over the Internet. It saved my life four years ago. I tried a new probiotic Margaret found at the grocery store made by Ethical Nutrients last week. It really made me sick. If this were a colitis post I would give you the brutal details but let's just say it caused great bloating and gas and other much more unpleasant symptoms. For a person with an inflamed set of intestines, bloating and stretching of the intestinal walls is about the most painful thing that can happen. Imagine someone kicking you over and over in an already badly purpled and bruised shin. You get the idea.

I called the 800 number on the bottle and was told by the very nice people at Ethical Nutrients about my symptoms. They assured me that they received calls about bloating, gas and stomach noise a lot. It usually lasted two weeks. I should just keep taking their probiotic and not mix it with any other. Eventually I would feel better.

I do not think I would have lasted two weeks. I went back to good old VSL#3. Sorry Ethical Nutrients, no matter how nice you folks are, I am not taking anything that caused that much pain.

This morning I finally felt well enough to try some yard work. I got out the ladder and started trimming the blooming and very smelly flowering jasmine on the trellis by the front porch. (The perfume has been getting into the house and closing up Paul's lungs). As I climbed the ladder and started trimming under the roof overhang I ran into a paper wasp nest. Luckily the wasps were not aggressive. Thank goodness for a cool day. I was not stung, but I sure got down from the ladder quickly.

I sprayed the wasps. Hopefully I will be able to finish the trimming of the flowers tomorrow and Paul's lungs will be better.

Our best to you all.


Thursday, March 29, 2007

Autoimmune News

March 30, 2007

I am creating this blog to post the latest information about autoimmune disesease. I have spent the last seven years of my life searching for answers and treatments. I have found a lot of both, if you are mouse. In fact there are close to forty ways to manipulate a mouse's immune system or bone marrow (from which the imune system comes) to create real cures and treatments that are so good as to be the equivalent of a cure.

Sadly the FDA has rules in place that keep those cures from people and encourage Big Pharma to fund only the surest, easiest, and most likely to work treatmentsthat are merely copycats of already established treatments (see all the anti-TNFalpha drugs). The FDA delays true revolutionary treatents by decades during which our community members and their families suffer and many of us die.

We, as an autoimmune community, must come together to change FDA guidelines for clincal trials including the initiation of phase zero testing, compassionate use without penalty for the companies involved, new guidelines allowing biologicals to qualify for all autoimmune diseases at the end of any successful autoimmune phase three trial. Right now new treatments are approved for one autoimmne condition at a time. Each new set of clinical trials costs a billion dollars. Hence autoimmune sufferers who have the most members have the most approved drugs. You know who you are RA and MS folks. No FDA approval. No insurance coverage. You want to pay yourself? Few doctors will "off label" prescribe the new biologicals, such an act might threaten their medical "career investment." At least that is the fear. The other problem is most doctors are afraid of biologicals because they did not learn about them in medical school. "Damn, new-fangled medicines!"

Autoimmune dieases were artificially separated from each other sixty years ago based on what structures in the body were attacked. If the skin is attacked, call it psoiasis. If the skin gets blisters-pemiphagus. If neural sheaths were attacked--Multiple Sclerosis. If joints were attacked Rheumatoid Arthritis. The medical knowledge at the time did not allow the namers of the 80 or more autoimmune disease to understand they all autoimmune disease had the same underlying mechanism--a dysfunctional bone marrow. Besides each time a researcher named a new one, he got to publish in a journal. The pursuit of prestige is a driver of men.

A successful bone marrow transplant has been known to cure all autoimmune diseases and dyfunctions (including asthma and allergy) for over thirty years. Combination Leukemia and RA victims who were successfully transpanted have been cured of both since the 1970's. [Sadly the immediate death rate for bone marrow transplant is between 10 and 25 %. There continue to be even more deaths from infection and Graft versus Host disease as years progress beyond transplant. So the bone marrow transplant is not used often.] Nevertheless the fact that RA and other autoimmune disease are cured by a new bone marrow has proved to medical researchers that the cause of autommune is not in the skin, joints or nerves. It is in the bone marrow.

A cure for one autoimmune disease is a cure for all. Instead of MS walks in April, there should be autoimune walks and demonstrations. The entire autoimmune comunity should join in. RA, MS, Lupus, Crohn's, Ps and PsA organizations should all be in that march. Law makers should be innundated with demands to solve the autoimmne problem. The cures are there. Let's get them to those in pain now! not ten or twenty years from now.

The AIDS community organized and their pressure forced the goverment to find highly successful treatments in less than ten years. When the AIDS comunity organized, conventional wisdom condemned it as a fool's errand. At the time no one believed that any way would be found to stop AIDS for fifty years or more. Yet in less than ten years, AZT was discovered and given to patients. We are in a far better position today than the AIDS community was in the 1980's. The cures are here now. We only need to demand that ALL autoimune patients have access to them.

Our family of four has dealt with immune dysfunction for over thirty two years. At first the health problems were mostly mine. Starting in our first years of marriage, I had unexplained angioedema, urticaria, apnea,and synope. When my wife and I discovered that the symptoms could be alleviated by the elimination of a couple of foods, eggs and tomatoes, we were relieved.

Our doctors at that time assured us that the problems were all psychological in nature. Even the sudden loss of lung function was not dangerous. It was hysteric. Once I lost conscousness, my lungs would open and I would breath normally again. No one died of such things. (At that time, 1977, there were thousands of asthma deaths every year but apparently no one told the family doctors.) In fact all autommune disease of any kind in the 1970's was caused by stress. Just cut out the stress and worry in your life and you could be like every one else. All immune disease was the fault of the afflicted. Every doctor knew that and they graciously assured us all of that. Don't worry about passing it on to children. As long as they are not stressed and hysteric like you, they won't have it.

We decided to have children. We had two fine sons. The eldest is a sucessful lawyer. No sign of any autoimmune disese or immune dysfunion. The youngest has severe reactions to foods and medicines as I did. In addition he has very severe psoriatic arthritis. He cannot walk unaided, use his hands to lift a metal fork or manipulate a computer mouse. He cannot even talk as the tendons in his vocal cords are affected. He is in constant pain.

He was a brilliant student in high school and college. He had a wonderful belly laugh that I shall never hear again. He had a beautiful singing voice. He played the keyboard. He was dating lovely, sweet, wonderful girls. His college years were his golory. For a time he was the editor of his college newspaper. Then in his senior year he developed what we thought was a strained knee. It wasn't. It was the first attack of psoriatic arthritis. Less than a year after his diagnosis, he could no longer use his hands or talk or walk without canes. That diagnosis was in January of 2004. He was totally disabled and unable to care for himself by January 2005.

I want to see him cured before I die. I am extremely ill now, barely able to eat any food. When I try I have severe symptoms of nausea, intesinal bloating, spasms, diarrhea and unbelieveable unrelenting bowel pain. I have lost twenty five pounds in two months and there is no sign of improvement. My time is running out. I have tried all the rescue meds--prednisone, Sol-u-medrol, antihistaines, antibiotic treatment. All worked initially but I reacted to each in turn with life threatening adverse reactions. Today a Chinese herbalists who also had an MD told me that he could not help me because I could not take herbal teas without syncope. Even though he takes complicated cases, he saw no hope for me.

We need these cures now.