Thursday, December 30, 2004

Cord Blood for ALS: a Petition

In the truest sense of “Life, Liberty, and the Pursuit of Happiness…”
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...a PETITION for humane, responsible action:

To President George W. Bush, members of Congress, and the U.S. Senate:

We the undersigned urgently request your prompt assistance towards encouraging or directing the FDA to immediately cease interfering in physician-administered transfusions of whole, untreated human umbilical cord blood into American patients with ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gerhig’s Disease).


Be it known:

· ALS is a fatal ‘motor neuron’ disease with no known cause, effective treatment, or cure.

· The animal model of ALS (Mutant SOD mouse) reflects a condition found in less than 5% of human ALS patients.

· Patients diagnosed with ALS often die within one to several years of its onset. The degenerative course of this disease involves ever increasing paralysis until the patient is unable to move, breathe, speak, swallow, or eliminate bodily wastes.

And…

· Research using transfusions of whole, untreated human umbilical cord blood into animal models of ALS at three U.S. universities (Harvard, University of New Jersey School of Medicine, University of South Florida Center for Brain Repair) led to the delay of ALS symptoms and prolonged animal’s lives.

· Similar studies report positive effects through cord blood use in animal models of Parkinson’s Disease, Alzheimer’s, Diabetes I & II, Lupus, Huntington’s Disease, Heart Disease, Stroke, Breast and Prostate Cancers, and Spinal Cord Injury.

· Cord Blood transfusions are widely used in mainstream medical practice in treating Americans with bone marrow or blood disorders. The FDA does not restrict cord blood use for these conditions.

· After initially instructing families and physicians of ALS patients that the FDA had no objection to their seeking cord blood treatments, provided the cord blood cells were only minimally manipulated, the FDA stopped these treatments after they had led to partial reversal of paralysis in 17 of 46 American patients despite no reports of serious adverse effects. (see 'letters of anger and hope' http://cordbloodletters.blogspot.com/ )

· Positive effects are quickly seen (within days to weeks) in human ALS patients through cord blood use. These early effects are not thought to be due to regeneration of brain and spinal cord neural circuits, although in time this too may occur. Researchers believe these early results may be due to cord blood having a "rescuing effect" on dysfunctional motor neurons.

· In addition to being a ‘therapeutic’ cause for ALS hope, cord blood transfusions may serve as a unique ‘clinical research tool.’ Understanding cord blood’s mode of effect may shed light on the underlying cause of ALS, leading to more effective treatments, or cures. (This benefit is unlikely to be gained through animal testing, since the underlying cause used in the animal form of ALS is found in less than 5% of human patients.)

· Transfusions of cord blood into ALS patients take place exactly as is common practice for patients with bone marrow or blood disorders. For both sets of conditions (hematopoietic and ALS use), as well as in pre-natal and newborn infants, cord blood travels throughout the body into all the body’s organs.

· No reports exist of cord blood having caused adverse effects in any organ (after successfully treating tens of thousands of humans with hematopoietic cancers), provided bone marrow ablation is not used to wipe out the patient’s bone marrow and/or immune system.

· No evidence suggests that cord blood transfusions pose any greater risk for non-hematopoietic medical use (such as ALS, Parkinson’s, Alzheimer’s, Stroke, Spinal Cord Injury, Huntington’s Disease, and Diabetes) than it does for hematopoietic use (bone marrow and blood disorders).

. Recent headlines have exposed questionable FDA 'pro-pharmaceutical industry' practices regarding its approval of dangerous medications and food additives. Completely ignored, however, is the FDA's policy of protection for pharmaceutical financial interests, as this senseless instance of treatment suppression reveals.

And…

. ALS patient Major Michael Donnelly (ret.), a decorated fighter pilot from Desert Storm, received cord blood in 2002 through the kind assistance of the White House Office for Veteran's Affairs. His first treatment, which led to partial reversal of paralysis, was attended and approved by the V.A.'s Surgeon General. Today, 18 months since the FDA stopped his treatments, Major Donnelly cannot speak, breathe, eat, or move at all except to blink.

. A few days before Christmas Major Donnelly’s physician recently received advance notification that the FDA did not consider his condition to be an emergency. On January 6th, the FDA denied the physician's request to treat Major Donnelly, despite a bi-partisan humanitary request by four U.S. Congressmen and a U.S. Senator.

· While American patients with bone marrow or blood disorders are free to benefit from cord blood’s medical potentials, ALS patients who have no other hope at present are denied the right to possibly benefit from similar treatments. This discriminatory policy by the FDA represents an arbitrary, capricious, inhumane breach of public trust.

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To sign this petition follow either of the following instructions:

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1. Include your name, hometown and state, and email address in a 'comment' to this post ('comment' link found at the bottom of this page).
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or...
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2. Send your name, hometown and state, and the following statement to Cures1st@msn.com.

To President George W. Bush, members of Congress, and the U.S. Senate:

A Petition: I urgently request your prompt assistance towards encouraging or directing the FDA to immediately cease interfering in physician-administered transfusions of whole, untreated human umbilical cord blood into American patients with ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gerhig’s Disease).

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Thank you for your interest in this extremely important matter of Public health!
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