Feb. 10, 1999
Potentially Infectious Colombian Kidney Tissue
Used in Clot-Busting Drug Abbokinase
Suspect Tissue From Deceased Newborn Babies and Aborted Fetuses
Imported in Violation of U.S. Law, Used in Prescription Drugs
WASHINGTON, D.C. — Potentially infectious kidney tissue harvested from deceased newborn babies and aborted fetuses is being used in the clot-busting drug Abbokinase, said Dr. Sidney Wolfe, Director of Public Citizen?s Health Research Group, in a letter today calling for an immediate recall of the drug sent to Food and Drug Administration (FDA) Commissioner Dr. Jane Henney.
According to FDA inspection reports and other information on the import of the tissue obtained by Dr. Wolfe, Abbokinase has been derived from kidneys taken from deceased newborn babies or aborted fetuses in a hospital in Cali, Colombia, without evidence of adequate informed consent from the parents, and without adequate screening or testing of babies or their mothers for infections.
Then, in violation of U.S. law, it is imported into the United States by BioWhittaker without being declared through customs as an FDA-regulated commodity or identified as “Treat as Potentially Infectious.” It is then processed by BioWhittaker and sent to Abbott Laboratories, in Abbottpark, Illinois.
Tens of thousands of Americans used Abbokinase last year, representing $250 million in sales for Abbott.
“This kidney tissue has been obtained from Colombia under extremely suspicious circumstances and has been processed in an extraordinarily dangerous way, exposing patients to potentially contaminated Abbokinase,” said Dr. Wolfe. “It is difficult to come up with a more dangerous scenario for an FDA-regulated biologic.”
The documents obtained by Dr. Wolfe reveal that following an FDA inspection of BioWhittaker in July/August 1998, an import ban was placed on the neonatal kidney tissue from Colombia, but the FDA rejected the recommendations of its field staff and refused to seize or recall material imported before that time.
The FDA inspection of BioWhittaker (in Walkersville, MD) discovered that the company failed to segregate the human kidney cells to be used in the production of Abbokinase “from potentially infectious material of human and animal origins (human tumorigenic cell lines, African Green Monkey, Buffalo Green Monkey, Rhesus Monkey, Cynomolgus Monkey, canine, and Rabbit sources….”
It also found “no assurance that orphans with unknown mothers are not used as a source of Human Neonatal Kidney Cells,” nor “verification that the parents of the neonates signed the consent forms for the use of neonatal tissue.”
The FDA then inspected Abbott Laboratories itself in October/November 1998. Referring to separation/purification column resins which are part of Abbott?s manufacturing process, FDA inspectors discovered that “No validation studies have been conducted to assure that any virus (or other contaminant) potentially retained on the resin or column, would be adequately removed or destroyed prior to reuse, preventing cross-contamination between lots.”
Instead of banning the product, the FDA responded by including the following information on the Abbokinase label: “The kidney cells used in the manufacture of this product were obtained from populations at high risk of a variety of infectious diseases, including tropical diseases.”
Last month, the FDA admitted in a letter to health care providers that “the actual risk to patients of developing an infectious disease as a result of using Abbokinase is unknown….”
Today?s letter from Dr. Wolfe to Dr. Henney suggests safe and effective alternatives to Abbokinase and urges an immediate recall of all Abbokinase products: “If FDA does not recall these products, considering the unknown risk of infection … what assurances do Americans have for the safety of many other FDA-regulated biologics, such as the blood supply?”