Cancer Horror Stories

JESSE GELSINGER: SACRIFICED TO GREED?

QUESTIONS ABOUT PENN'S ANIMAL OTC STUDIES

Even more shocking, an FDA investigation found that the animal studies, which served as a basis for the later human trials, were fraught with deficiencies and violations of the rules.

In a fifteen-page letter to the University, the FDA cited a broad range of specific examples including:

• Violations of the research protocol for the project explained away as "amendments" to the design that were not written until long after the actual experiments were completed.
• Failure of researchers to properly dilute the viruses used in some of their animal studies.
• Use of viruses that were more than two years old, and that had past their expiration dates.
• Understating the degree of liver damage experienced by the experimental animals.
• Inconsistencies in pathology reports. In one instance a report stated that a monkey had been euthanized, while another lab report said the animal had been "found dead." Since the deaths of monkeys during these experiments had predicted the complications Jesse Gelsinger experienced, any information concerning their demise would be particularly important.

The NIH conducted tests of a strain of adenovirus closely related to the one Wilson's group was using on macaque monkeys. All of the test animals fell seriously ill and while they recovered, one suffered permanent liver damage. In a German study using rabbits, the adenovirus caused symptoms identical to those that eventually killed Jesse.

It wasn't just animal experiments with the adenovirus, which demonstrated deadly potential. An experiment at the University of California sponsored by the Schering-Plough Corporation, in which terminal cancer patients had their livers infused with an adenovirus ultimately was cancelled due to adverse effects.

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Contact Kathleen Deoul, Media Matters
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