Wednesday, January 28, 2009

Major Medical Research Problems in the United States

Problems with Medical Research the FDA and current US clinical trials (DRAFT)

Good drugs take too long to get to really sick. Fewer drugs are being approved each year by the FDA. The drugs approved are taking longer and longer to go through the Byzantine clinical trials procedures wastefully required by FDA. The FDA bureaucrats only concern seems to be keeping their job protected. The safe answer is always NO! Let’s delay a little longer. No one ever got fired or sanctioned because patients died while waiting for a new therapy. Saying no means job security. No concern is shown for Americans who are sick, suffering and dying while we wait for the bureaucrats to make sure their little careers are perfectly safe. Allow these revolutionary new therapies to get to the sick and dying now!

Clinical trials are biased and give skewed results. Carefully screened selections do not give good results. They give skewed results. Screening patients to obtain those who will give you the desired outcomes is NOT SCIENCE. It is a rigged game. The whole basis of a scientific experiment is to have data inputs that are unbiased and random. Otherwise it is not science. No one can have confidence in the results.

There is no compassionate use. The concept is a hoax. Big Pharma companies have no compassion and always deny use. Under current law when Big Pharma inevitably says no to access there is no appeal and no exceptions. Not even court action can help. See the following Wall Street Journal article about a boy sentenced to death by a drug company. The courts refused to help.

All patients who wish access should be given access. That is a matter of basic fairness and decency. Good old fashioned American values. We have a right to life and right to access medications that will preserve our lives.

Placebos are mass murder.

Clinical trials cost too much. Now approximately 1.2 billion a piece. $26,000 per patient just for the phase III trials and thousands of patients are required by antiquated FDA regs

Clinical trials are needlessly long. It is now taking DECADES from DISCOVERY TO the PRESCRIPTION PAD! It should take months maybe weeks. Ustekinumab, a revolutionary new medication for psoriasis, that had “stunning results” announced after phase II trials were completed in February 2007, still has not been approved by the FDA rhymes with delay. It was UNANIMOUSLY recommended for approval by an independent panel of scientists and patient advocates in June 2008. Clinical trials head to head with Enbrel the current number one best seller for psoriasis showed it gave BETTER RESULTS. Gene studies of patients with psoriasis released in January 2009 confirmed that one of the major gene defects causing psoriasis causes an increase in the pro-inflammatory IL-23 cytokine. Guess what Ustekinumab blocks? Still the F’ing DelAy still has not allowed Ustekinumab to get to patients who need it. Approval is still blocked. Canada has approved it but not the FDA in US. We will have to go to Canada to get it? Our family lives in San Diego County near Mexico. We are thousands of miles away.

Wrong criteria measured. Instead of biometric measurements of cytokine levels and autoimmune marker molecules, our backward friends use such outmoded measuring instruments as PASI and the ACR measurement. They literally measure how big the psoriatic lesion is or how swollen the joint is. That kind of measurement is so 16th century. We live in the 21st century. Let’s use 21st century measurements. They are far more accurate.

There is a better method. It is cheaper, faster and more fair. The method is to throw it all at the wall at once see who is helped. It is called trial and error. It is a powerful method of discovery—perhaps most powerful ever discovered by humans. It is the method that traditional Oriental medicine used to discover artemisinin and (anti rejection drug based on Asian fungus I forgot name) Wait, I remember, Tacrolimus! That’s it. Both of these and MANY others have been discovered by Trial and Error and Serendipity.

Our current clinical trial method is resulting in less accurate results in more expensive trials. We are getting fewer new drugs approved ever year. We have more dead and suffering Americans for ever longer periods of times.

This is a historic tragedy because for first time in history of man, we have the tools and knowledge to rapidly to end many chronic diseases that had no chance of cures in the past. These diseases include all forms of cancer and all forms of autoimmune (RA, PsA, SLE, MS, diabetes I, etc.) All hematological disease as well like hemophilia, beta thalassemia, sickle cell anemia could fall in the next TWO YEARS. There is already a company Osiris with a stem cell product Prochymal that offers hope for cures for half of all autoimmune patients, infections, and cancers. Prochymal might not cure all of those. But the concept it is based on definitely can.

Lift all bans on testing patients and test as many as will volunteer with as many possible medications and COMBINATIONS of medication ASAP.

We are running out of time when it comes to our country’s wealth. We will not be able to afford this research for much longer. Small Pharma development companies are going out of business by the score. With their demise go the cures that they were working on.

The antibiotic super bugs are poised to kill millions of Americans. Already we are amputating limbs of injured soldiers who have compound fractures because of unstoppable infections—Iraqui-bacter and MRSA among others. We are back to CIVIL WAR medicine. In those times Civil War times not only were soldiers affected but 1/3 to ½ of all children died of infection before having children of their own. Is that what we want again?

We must have the US government DIRECT the research by setting goals and rewards by eliminating all roadblocks and forcing companies to share intellectual resources and when discoveries are made financial rewards.

Directing research can be done. Today we have the tools for directed medical research to cure virtually all chronic disease, not to mention stopping the emergency of the outbreak of the killer super bugs that today kills more people in US than AIDS.

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