A Humane Request Denied

2005-01-08T11:46:00.000-08:00

The following letter presents a simple request. Four members of the U.S. House of Representatives and one U.S. Senator urged the FDA to grant a request for 'emergency IND' approval, permitting an ALS patient who had previously benefited from cord blood transfusions to resume the treatments.

At present the patient cannot speak, eat, breathe, or move.

Two weeks ago the FDA told the patient's physician that they didn't consider the patient's condition to be an 'emergency.' On January 6th at 4:30pm the FDA called the physician to announce that the request had been denied.

It should be noted that although Major Donnelly's family specifically asked the following congressmen and senators to make inquires to the FDA on his behalf, and signed a release authorizing them to do so, the FDA refused to provide any information regarding his case and their deliberations, citing the need to "respect the patient's right to privacy."

One can't help wondering whether the FDA is more concerned with protecting the patient's privacy, or their ability to stonewall congressional oversight. At any rate, it would be nice if the FDA had more respect for the patient's life.
_______________________________________________________________

December 21, 2004

The Honorable Lester Crawford
Interim Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Crawford:

In recent years the medical possibilities offered by human umbilical cord blood has become increasingly evident. Use of cord blood for a variety of diseases has proved successful for many patients and has presented minimal side effects.

Some patients with amyotrophic lateral sclerosis (ALS) are encouraged by the progress shown by use of cord blood treatments. As you know, patients diagnosed with ALS face rapid neural deterioration and death within several years. There is no effective treatment, leaving these patients with little hope.

We write with particular interest in the Investigational New Drug Application (IND) submitted by Dr. Nizar Souayah. Dr. Souayah's IND requests approval to perform the treatment on Michael Donnelly. Mr. Donnelly received a cord blood treatment in November of 2002 and saw improvement. The treatment was well tolerated and there were no evident side-effects.

It is encouraging that Dr. Souayah has submitted the application and that the IND process is available in situations such as this one. Given the gravity of Mr. Donnelly's condition and his positive response to previous treatment, we believe that Mr. Donnelly is an excellent candidate for treatment.

Time is running short for Mr. Donnelly and he has no other options. It is our hope that the IND would be processed and approved swiftly. Please notify us of the current status of the request as well as your agency's the final decision.

Sincerely,

W. Todd Akin
U.S. House of Representatives

John Larson
U.S. House of Representatives

Joseph Lieberman
U.S. Senate

Christopher Shays
U.S. House of Representatives

Christopher Smith
U.S. House of Representatives

FDA says "No" to Congress

A Humane Request Denied