Wednesday, January 05, 2005

cause for anger, reason for hope


We, the family of Human Umbilical Cord Blood (HUCB) Patient #2 Kent Young, found definite improvement in his physical, mental and emotional health for up to 9 months after HUCB treatment in Atlanta. So much so, that a booster of HUCB was to be done in Mexico over Labor Day Weekend 2003 as he began to lose strength. It was cancelled due to the lack of the whole fresh blood type Kent needed, B Neg. We truly wish that he had the opportunity to have had that booster. His life ended on Dec. 21, 2003 as he also was in the same situation as Major Donnelly seems to be in now. There is no time to waste. It is a critical situation. Kent left a wife and four young children; that in itself makes the lack of being allowed the HUCB treatment even more critical. We continue to see HUCB as the only possible safe treatment at this time. Each person should be allowed to decide "to choose life."

Ruth Young, mother of Kent Young

My Wife of 40 years was denied this treatment by the FDA in March 2003. FDA has taken a horrible and inhumane position on this issue. My wife was literally told by this interference to just go home and die, we, at the FDA will not try to help you! She did that for FDA February 17, 2004. Had she had cancer, she could have received this treatment. With ALS she was denied this simple procedure by the FDA. There is not one shred of common sense in their position and they know it. In my opinion, this is criminal neglect to dying citizens for the sake of political positions within the FDA bureaucracy. I will never forget and I will never forgive this disgraceful act against my late wife and the thousands of ALS patients who already have already died, or will also die without hope or help from the FDA. Mr. President, please stop this insanity of FDA interference for needed treatments. (Continued...)

Jerry D. Hoggatt
Wichita, Kansas

Website manager's note: Fran and Jerry Hoggatt fought valiantly for Fran's right to reach for life through cord blood. The following links present the justice and urgency of Fran's and Jerry's efforts.

My brother, Major Michael Donnelly, a decorated F16 fighter pilot who flew 44 successful combat missions in the Persian Gulf War, is now afflicted with ALS as a direct result of his service. My brother served his country well. I ask that his country consider the following while Michael silently waits in his hour of need!

Michael benefited from a cord blood treatment before the FDA stepped in to stop the treatment. I witnessed what appeared to be almost miraculous improvements in his physical condition. He cried with joy as he lifted his legs from the bed for the first time in years. The improvements were small, but unmistakable. They were witnessed and acknowedged by numerous people who had spent a long time watching his decline. His physical and respiratory therapists were both astounded at the improvements, and both said they would not have believed the improvements possible if they hadn't witnessed them in person.

Michael received this treatment at great expense to my family, although the treatment was done with the knowledge of several individuals in Veteran's Affairs. All are well meaning people who wanted only to ease Michael's suffering, and the suffering of others with ALS.

We have no time to lose. Lives are at stake while bureaucrats hold forth in pompous denial.

We need to act now while lives that might be saved hang in the balance!

Denise Donnelly
Rockport, MA

[Note by website manager: Major Donnelly's 'emergency IND' application to the FDA was denied on Jan. 6th, 05, despite a bi-partisan request for its humane approval by four Congressmen and a U.S. Senator.]

After being diagnosed with ALS in June, my wife and I have researched treatments to halt or slow progression of the disease. Of the few options available, cord blood treatments appear to hold the most promise.

We eagerly awaited the FDA’s decision on Dr.Souayah’s IND request to adminster cord blood treatments to Michael Donnelly. Dr. Souayah hoped to improve on cord blood infusions previously given to ALS patients, before the FDA halted the treatments in mid-2003.

Unfortunately for me and others with ALS, the FDA rejected Dr. Souayah’s request. I had been in touch with Dr. Souayah and he agreed to ask for FDA approval to treat me if his IND request to treat Mr. Donnelly had been approved. Now, my hope has been shattered.

Why does the FDA approve cord blood treatments for Americans with cancer, but denies the same request for those with ALS? The FDA’s decision reflects a senseless, discriminatory policy that shows absolutely no regard for the lives and suffering of thousands of ALS victims. I and others with ALS don’t have time to wait on the sidelines while the FDA plays bureaucratic power games to curry political favor or protect pharmaceutical industry interests (which stands to lose if cord blood treatments prove successful).

I deeply appreciate the strong support from several concerned Congressmen (including Congressmen Akin, Larson, Mays, and Smith, and Senator Lieberman) and question why President Bush and others in Congress do not share our concern and sense of urgency.

Would they sit idly by if they or a member of their family was diagnosed with ALS?

Lynn Chitwood, 'Bulbar' type ALS patient
Atlanta, GA

On viewing the bi-partisan congressional request on behalf of Major Donnelly, and seeing the subsequent denial by FDA for an emergency IND for cord blood transfusion; I must make the following statement.

Major Donnelly was willing to die in this country's service. Therefore America should at the very least allow him the right to try to live.

Having read his story, "Falcon's Cry," and knowing he returned home with a neurological condition diagnosed as ALS, is most tragic. In viewing his photos I saw a strong, handsome, smiling, physically fit human being. I know full well where he has been brought in his final stage of dealing with ALS. He and HUCB pat. #2, Kent Young, were so similar in many ways.

Kent had wanted to pursue the HUCB treatment here in the states and was convinced that if it had been available it would have given him back a certain quality of life with his ultimate goal being a cure. He wanted to see his 4 children grow up. If Kent could not have this chance, he wanted others to have it.

We are on the cutting edge of a whole new concept of curing disease and saving valuable lives. Major Donnelly surely fits that classification. Through our family's tragic ALS experience we continue to hold to two thoughts:

"Life is in the blood." and:

"Choose Life."

Ruth Young
Gillette, New Jersey

This letter is in answer to your questions concerning the safety of cord blood transfusions. To my knowledge there is no evidence in the literature to indicate that transfusions of infant blood (cord blood) present greater risks than transfusions of appropriately tested blood from adult donors.

During the late sixties and seventies, I was involved in giving multiple cord blood transfusions to fifteen patients with various terminal malignancies. These 15 patients received 139 units of cord blood. I recall that there were no adverse reactions at that time. However, I recently reviewed my records of these treatments and confirmed that no significant reactions were noted, only one case of cold antibodies. My personal option is that transfusions of infant blood (cord blood) is safer than transfusions of blood from adult donors.

Norman Ende, M.D.
Professor of Pathology and Laboratory Medicine
New Jersey School of Medicine.

Professionally I was quite intrigued by a report that presented mechanically measured FVC functional changes in ALS patients through transfusions of multiple whole cord blood units matched for blood type (link to chart). In addition to obvious therapeutic potentials, in my opinion these treatments may offer a unique opportunity for understanding causes of ALS found in much larger percentages of human patients than the present mouse mutant SOD model reflects. This could have important implications for the efficient development of more effective treatments.

Jean Peduzzi, Ph.D.
Associate Professor of Cell Biology
Department of Physiological Optics
University of Alabama at Birmingham

Cord Blood for ALS: the Petiton
FDA Cord Blood Suppression: a History
Cord Blood Research
FDA says "No!" to Congressional Request