Friday, January 07, 2005

Notes on Senator Lieberman's Inquiry

1) According to correspondence in Senator Lieberman’s possession, the FDA had indicated to families and physicians of ALS patients that no regulations barred ALS patients from receiving transfusions of whole, untreated umbilical cord blood.

2) Despite these assurances, in 2003 the FDA contacted two American physicians treating ALS patients in this manner, instructing them that the FDA required that they apply for- and be granted IND approval to continue the treatments.

3) This ended all development of this therapy. The prohibitive labor and costs of filing for an IND and conducting a controlled clinical trial under IND guidelines were well beyond the means of these private practitioners.

4) Patients who had received initial therapeutic benefits from transfusions of whole, untreated cord blood were barred from further treatment.

The following slides present the FDA's response to Sen. Lieberman's inquiry.


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