Seeking the Withdrawal of Approval for Posilac [R].

• Author: Kimbrell, Andrew

[On December 15, 1998, the Center for Food Safety (a project of the International Center for Technology Assessment) and 20 co-petitioning groups submitted a Citizen Petition before the United States Food and Drug Administration, entitled "Petition Seeking the Withdrawal of the New Animal Drug Application Approval for Posilac[R]--recombinant Bovine Growth Hormone (rBGH)." The article below is excerpts from the petition. Ed.]

New Evidence of Imminent Human Health Hazard.

1. New Evidence of Oral Activity and Absorption of rBGH.

   In 1990, the FDA published a justification for its determination that milk and dairy products derived from rBGH-treated cows was "safe for human consumption." The article contained seven tables of data supporting its conclusion, including two tables of data taken from an unpublished Monsanto study of rats orally fed rBGH at high levels. In its 1990 conclusion, FDA officials state that the this 90 day rat feeding study showed that rBGH "is not orally active in rats" and found that, "No oral activity was found when rBGH was administered to rats at exaggerate doses." The FDA officials summarized this by stating, "No toxicologically significant changes were noted in the clinical chemistry, hematology, or urinalysis parameters determined in rats administered rbGH orally."

   On April 21, 1998, however, health officials from Health Canada issued a comprehensive report finding, inter alia, gaps in the scientific data used in FDA's review of human health risks associated with rBGH use. This Health Canada review included a thorough analysis of the comprehensive data reviewed by the FDA during its decisionmaking process.

   Contrary to FDA's conclusions, the Health Canada data review found evidence that laboratory rats orally fed high doses of rBGH were absorbing the substance. More specifically, the report details that a Monsanto 90 day rat feeding study actually found that between 20% and 30% of the rats in the study developed primary antibody response to rBGH--an indication that orally administered rBGH was absorbed into the blood stream and it produced a distinct immunological effect. Additionally, the data showed that in the male rats cysts formed in the thyroid and an increase infiltration of rBGH into the prostate.

   Health Canada report's found that the publicly released summary of safety and effectiveness data and information supporting Posilac's new animal drug application used during the FDA decision-making process on rBGH did...