On-Line Petition for Access

I came across an on-line petition site http://www.thepetitionsite.com/1/heal-the-FDA urging the FDA to hurry the cures of type I diabetes, an autoimmune disease like psoriasis. My son has two cousins with Type I diabetes as well as several more with psoriasis. The tendency for autoimmune disease runs in families. While I wish the petition on line would advocate for all autoimmune disease and not just diabetes Type I, it did seem like a good idea to sign. At least it cannot hurt. Whether it will help or not I do not know. I urge you to go to the site and sign as well. Perhaps someone will listen.

I included the following statement with my signature. The statement below represents my frustration with the FDA.

FDA delays are not just a diabetes problem. My son has psoriasis, psoriatic arthritis, and ankylosing spondylitis. The FDA is grossly incompetent shows a complete lack of concern for all sick Americans. A NOVEL medication (Ustekinumab) showed "stunning results" for conditions like my son has in phase II clinical trial results released in February of 2007.

Naively back in the spring of 2007, I thought this brand new kind of biologic medication (anti IL 12/23) would be rushed to patients in weeks or at most a few months. I was sure that once the FDA officials in charge read about the results that they would do ever thing possible to get it to suffering patients. But NO! Here we are TWO YEARS LATER and the FDA still has not approved the medication.

Last June Ustekinumab was recommended for FDA approval by 100% of the outside experts who were brought in to evaluate it. That was SEVEN MONTHS AGO!

In September results of head to head clinical trial were announced. The trial had pitted ustekinumab against the number one prescribed biologic for psoriasis, Enbrel. Ustekinumab out performed Enbrel. The new investigational medication was more efficacious than the number one prescribed medicine. It has to be approved immediately, right? NO, that was FIVE MONTHS ago and there still is no approval.

Ustekinumab is ONLY a bridge to a future cure. But it is a dramatically better medication than anything now on the market. Its approval should be an EASY DECISION.

My son has nearly died twice form the severe inflammation in his ribcage due to the PsA and AS. In the summer of 2007, my wife and I watched him struggling to breathe, wondering which would be his last breath. We desperately tried to get Ustekinumab from the manufacturer and were TURNED DOWN! There is no appeal not even a court appeal (google Jacob Gunvalson to see how useless the courts are). The FDA gives TOTAL decision making power to the company. The dying patient HAS NO RIGHTS!

We have tried unsuccessfully for last two years to get compassionate use for our son to use ustekinumab. He has been denied over and over and over.

We have four times tried to get him into clinical trials. Four times he has been TOO SICK. He was excluded.

The myth that sick Americans can get access to investigational medication is a cruel hoax. The truly sick are denied due to narrow exclusionary and inclusionary criteria meant to get drug approved. The clinical trial and its criteria are NEVER set up to help patients. They are not even to get complete scientific results.

The current clinical trials system is rigged. There is no dearth of volunteers as the drug companies say. Instead there is a dearth of “just right” patients that are carefully pre-screened to give drug best possible chance of approval. Less than 10% of dying cancer patients are given access to clinical trials. THIS IS NOT A SCIENTIFIC SYSTEM, nor is it compassionate.

The sickest Americans are given NO access.

Today there is a chance for a cure for approximately 50% of autoimmune and perhaps 95% of blood disorder patients (beta thalessemia, hemophilia etc) who are “missing something.” The new treatment is called Prochymal by Osiris. Prochymal is an infusion of blood and immune forming stem cells from many donors of blood. It does not need to be matched for blood type. By providing the "missing factor" it turns off autoimmune disease in as little as a few days in some patients. Hemophiliac patients who are all missing clotting factor could be cured in a week or less. Diabetes could be turned off and insulin levels normalized in a month. Prochymal is just one of the MAJOR breakthroughs in cures that is being delayed by the FDA,s career protecting bureaucrats and by the FDA's Byzantine clinical trials protocols.

Prochymal should be tried on every autoimmune disease and blood disorder TODAY not two decades from now. Ustekinumab a big step forward but not even close to a cure yet even this relatively small step has been delayed for two years. Two years of dying and suffering patients for no reason. Still it should be approved today. It also should be tested on ALL other autoimmune diseases especially on ones with similar inflammatory pathways--diabetes type I , psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and others.

Prochymal, various autoimmune vaccines and other procedures offer the chance for LIFE TIME CURES. Why isn’t the FDA jumping on board and speeding up the approval of these revolutionary advances?

Ustekinumab is just one example of TOTAL INCOMPETENCE and feet dragging by FDA bureaucrats afraid to say "yes" to anything. There need to be a new kind of “affirmative action” hires for FDA bureaucratic jobs. These affirmative action folks would either have chronic disease themselves or have a family member with one. If the FDA decision makers had something to care about besides their protecting their jobs, then perhaps, they would allow these revolutionary new drugs and technologies come to market, QUICKLY!

Enough of industry insiders running the FDA! Enough of career bureaucrats protecting their back sides! APPROVE THE CURES NOW!