Tuesday, March 3, 2009


Which of these three letters scares you the most?

The FDA has done it again! Last December the FDA cleared the way for Neuralstem, Inc. to conduct clinical trials on ALS (amyotrophic lateral sclerosis) patients by injecting stem cells into their spinal cord. The company had filed an Investigational New Drug (IND) application with the FDA to begin a clinical trial to treat ALS. The plan is to treat ALS patients through spinal injections of stem cells via its patented Human Neural Stem Cell Technology at Emory University.

Last week the FDA put a hold on this clinical trial and said it needed more information about the manufacturing capabilities, and all studies and injection methods for treatment. Once again, as with other therapies, the FDA has asked for a modified protocol including a patient's eligibility to participate. How much more qualified can ALS patients be? If the IND describes the clinical trial that is directed solely at ALS what then is their alternative. Could it be that the FDA does not understand that having ALS is already a death sentence. The legal waivers to participate in any clinical trial could never match the horrors of ALS.

For the past 21 years, The Life Extension Foundation has compiled evidence indicating that the FDA is the number one cause of death in the United States. The FDA causes Americans to die by:

• Delaying the introduction of life-saving therapies
• Suppressing safe methods of preventing disease
• Causing the price of drugs to be so high that some Americans do without
• Denying Americans access to effective drugs approved in other countries
• Intimidating those who develop innovative methods to treat disease
• Censoring medical information that would let consumers protect their health
• Censoring medical information that would better educate doctors
• Failing to protect the safety of our food
• Misleading the public about scientific methods to increase longevity

A startling number of reports reveal the FDA is in far worse shape than originally thought. Few people comprehend that they are likely to suffer and die prematurely as a result of FDA’s failures. The greatest threat the FDA poses to our health is the fact that the agency functions as a roadblock to the development of breakthrough medical therapies. Innovation in medicine is stifled by FDA red tape, which is why Americans continue to die from diseases that long ago might have been cured.

Tell Congress we need an HHS Secretary now.
The clock is ticking on comprehensive health care and FDA reform - and for millions of Americans, time has already run out. Leaving us without a strong advocate in Washington is simply unacceptable.

Americans cannot afford to wait any longer. Tell Congress to work together for swift confirmation of Kathleen Sebelius as Secretary of Health and Human Services.

Sign the petition to be delivered to the Senate.

1 comment:

Anonymous said...

One set of rules doesn't fit all.

Think of all the FDA could learn from PALS who might enter into special trials with full understanding and consent to the risks.

FDA, if you can't cure those with ALS, then at least permit them to teach you things that might spare the next person from this disease.

A wise PALS once said of the FDA, "They're protecting us to death."