rBGH

• What is rBGH?
• Research on health
• The FDA policy
• Organic milk production footprint
• PCC's view and what you can do
• Links and resources

The FDA policy

The FDA's decision to approve rBGH in 1993 remains one of its most controversial decisions ever. At the time, dairy farmers, government leaders and scientists (including many scientists inside the FDA) raised questions about the integrity of the review process and criticized the influence of Monsanto, the manufacturer of rBGH.

Here are some of the reasons given for concern:

• Several people who worked directly for Monsanto or had close ties were hired by the FDA and placed in decision-making positions that involved approval of rBGH ... continued
• "Several scientists who worked in the FDA's Center for Veterinary Medicine in the 1980s and early 1990s complained of undue corporate influence that corrupted the science." ... continued
• Other FDA employees, upset by what was happening at the agency, wrote a letter to Congress and the General Accounting Office, asking for an investigation. When the GAO looked into the claims, it agreed that human antibiotic resistance risks had not been addressed for rBGH. However, Congress took no further action and the hormone was approved." (quoted from "Know Your Milk. Does it Have Artificial Hormones?" a publication by the Physicians for Social Responsibility Oregon Chapter)

Several people who worked directly for Monsanto or had close ties were hired by the FDA and placed in decision-making positions that involved approval of rBGH.

For instance, in order for the FDA to determine if Monsanto's rBGH was safe or not, Monsanto was required to submit a scientific report on that topic. One of Monsanto's researchers, Margaret Miller, put the report together. Shortly before the report was submitted, Miller left Monsanto and was hired by the FDA.

One of her first jobs for the FDA was to determine whether or not to approve the report she had written for Monsanto about rBGH. In short, in her new position at the FDA, Miller approved her own report prepared for Monsanto. Assisting Miller was another former Monsanto researcher, Susan Sechen.

The person who decided whether or not rBGH-derived milk should be labeled fell under the jurisdiction of another FDA official, Michael Taylor. Taylor previously had represented Monsanto as a lawyer at the King and Spalding firm in Washington, D.C.

He was hired by the FDA as the Deputy Commissioner for Policy in 1991, and during his time there until 1994, he oversaw approval of rBGH and the guidelines not to require labeling. Taylor returned to work for Monsanto in 1998.

"Several scientists who worked in the FDA's Center for Veterinary Medicine in the 1980s and early 1990s complained of undue corporate influence that corrupted the science." (quoted from "Know Your Milk. Does it Have Artificial Hormones?" published by the Physicians for Social Responsibility Oregon Chapter)

"Alexander Apostolou, director of the Toxicology Division, said 'I have witnessed drug manufacturer sponsors improperly influence the agency's scientific analysis, decision-making, and fundamental mission.' ¹

"Richard Burroughs, lead reviewer for rBGH for nearly five years, said officials 'suppressed and manipulated data.' ² For their whistle-blowing, Apostolou was forced to leave the FDA and Burroughs was fired."

1. Craig Canine, "Hear No Evil: in its determination to become a model corporate citizen, is the FDA ignoring potential dangers in the nation's food supply?" Eating Well, July/August 1991.
2. Ibid.