Monsanto's premier biotech product faces a tough sell abroad
In 1993, Monsanto received permission from the Food and Drug Administration (FDA) to market rBGH under the trade name Posilac. Recombinant bovine growth hormone stimulates the production of Insulin Growth Factor-1 (IGF-1), a hormone that increases milk production by an average of 10-15% in dairy herds. Scientific evidence has been accumulating for years linking IGF-1 to breast, prostate and colon cancers. Posilac's many critics charge that the FDA's approval process was corrupted by heavy pressure from Monsanto and its revolving door relationship with the agency, a claim that has been strengthened greatly by a Canadian government report released last August.
The report from scientists within HealthCanada (the Canadian equivalent of the U.S. FDA) says that the FDA misreported the results of a 90-day rat feeding study conducted by Monsanto in an article in a 1990 Science magazine article. The FDA reported that there were "no clinical findings" to indicate that further study was necessary to study potential health risks to humans. But the HealthCanada report says that a significant number of the rats developed antibody responses to rBGH, contradicting Monsanto's assertion that Posilac is completely broken down in the digestion process. Last month, an FDA official told a reporter that the agency relied only on the company's summary findings of the study in its recommendation and did not review the data - a violation of FDA procedures - but Monsanto claims that the FDA official misspoke.
The Canadian scientists' report is critical of the Canadian government as well, saying that the latter did not require follow-up studies required by the 90-day study. According to Rachel's Environment Health and Weekly, the scientists testified before a government board of inquiry that they were threatened with transfers or demotions if they did not expedite Canada's approval of rBGH.
Worldwide, only the U.S. has approved the use of rBGH. Australia, New Zealand, Israel and Japan have banned rBGH. Canada has yet to approve its sale and use. The United Nations Codex Alimentarius Commission (Codex), a joint body of the World Health Organization and the U.N. Food and Agricultural Organization, voted to defer a decision on whether to approve rBGH for use until the year 2000 to allow time for further research into the product's safety. The European Union abides by Codex's recommendation.
According to Monsanto, profits from using Posilac "mount swiftly" once
the break even level of milk production is reached. Depending upon the market price
of milk and the herd's average increased output from using the hormone, return on
investment can range as high as 77 to 125%, as compared to a typical overall rate
of return below 10%. The company notes that "as milk price drops, the profit
derived from using rBST will account for more and more of the total farm profits...
[A]t low milk prices the profit derived from rBST may account for as much as one
half or more of total farm profit." Thus, as more and more farmers use Posilac
and drive the market price down by expanding supply, pressure will increase upon
non-users to get with the program.
Farmer Charles Knight of Florida told reporters that $50,000 worth of rBGH injections
resulted in unusable, pus-filled milk. Monsanto and Monsanto-paid researchers told
him the problem had to have been due to other herd mismanagement on his part, and
failed to report his complaint to the FDA as required.
Human Health Risks
The FDA accepted Monsanto's case for approval based on its arguments that IGF-1 was a digestible protein and that its 90-day feeding study of thirty mice had established no side effects that warranted longer term study for human or animal safety. But the 1998 Canadian government report contradicts the findings reported by the FDA that rats remained unaffected by their exposure. It revealed that 20-30% of the mice tested positive for IGF-1 antibodies - evidence that IGF-1 was not fully digestible and that long term studies were warranted. The FDA had never allowed anyone outside the agency to review the data from the feeding study.
The Canadian scientists point out that the FDA has acknowledged increased levels of IGF-1 in rBGH-treated cows. In a 1994 article in the Lancet, the influential British medical journal, Monsanto researchers claim that the hormonal content of rBGH-treated cows is no different than non-treated cows, yet an article in a later issue of the Lancet points out that the company admitted in 1993 that IGF-1 levels went up "substantially" in treated cows. Monsanto's web site currently states, "Posilac does not alter the chemical composition of milk."
Along with the Canadian report, scientific findings released earlier this year establishing a greater linkage between IGF-1 and breast cancer have kept the rBGH controversy alive. The May 9 edition of the Lancet, found that premenopausal women with high levels of IGF-1 in their blood plasma bear up to a seven-fold increase in the risk of developing breast cancer, suggesting "that the relation between IGF-1 and risk of breast cancer may be greater than that of other established breast-cancer risk factors - the exception of a strong family history of breast cancer." The authors called for more research to confirm the findings. According to a recent article in the British journal The Ecologist, the results of the Lancet study seems to confirm a detailed 1996 study by American scientist Dr. Samuel Epstein, which found increased levels of breast and colon cancers in subjects who drank rBGH-treated milk. In January 1998, a Harvard study of 15,000 white men published in Science magazine found that those with elevated (although still normal) levels of IGF-1 were four times at risk of developing prostrate cancer.
Non-cancer risks health risks associated with rBGH use include the development
of antibiotic-resistant bacteria in humans, and increased allergies to antibiotics.
These phenomena can occur when cows suffering from mastitis are treated with antibiotics,
whose residue remains in milk.
By Any Means Necessary
In a 1996 poll commissioned by the U.S. Department of Agriculture, 94% of nearly 2,000 surveyed expressed a preference for labeling that identifies whether milk is hormone-treated or not. In 1994, the FDA issued suggestions for voluntary labeling guidelines, suggesting that any labels identifying milk as rBGH-free also note that the FDA has said no significant difference has been shown milk from treated and untreated cows, and that there is no test that can make that distinction. Prodded by the Consumers Union, the FDA clarified that its suggested guidelines were just that, and that labelers were free to label as they wanted. The FDA says that it does not have the statutory authority to require labeling (a claim that the Consumers Union contends).
Monsanto has used intimidation tactics to discourage labeling despite the freedom of businesses to label as long as they do so accurately. When the FDA's issued its voluntary guidelines, the law firm representing Monsanto, Covington and Burling, sent letters to thousands of small businesses that stock dairy products informing them that should they label products rBGH-free, they could be vulnerable to legal action for mislabeling products since no test exists that can determine the difference between treated and untreated products. Monsanto sued two small businesses on these grounds, eventually settling out of court. Monsanto continues to oppose every state and local bill to require labeling.
While most states followed the FDA's guidelines, a handful of states instituted laws forbidding labeling regarding rBGH content. In 1996, Ben & Jerry's Homemade initiated a lawsuit against the city of Chicago and the state of Illinois challenging these laws on First Amendment grounds. Ben & Jerry's was joined by Stonyfield Farm, Whole Foods Market, and a Wisconsin-based farmers' cooperative. The state's laws had effectively stopped rBGH labeling nationwide, because it was infeasible for manufacturers to prepare different labels for different regions. A settlement was reached in August 1997 that in which anti-rBGH labeling is permitted that contains the following qualifying language: "The FDA has said no significant difference has been shown and no test can now distinguish between milk from rBGH treated and untreated cows."
The FDA official who approved the voluntary labeling guidelines in 1994 had spent several years as an attorney at a Washington, DC law firm that litigated on Monsanto's behalf. The revolving-door connections extend into Canada as well. One of the experts selected to objectively review the Canadian scientists' report had served as a consultant to Monsanto for five years until May 1998.
Examples have been set for would-be whistle blowers and critics in academia, government and the media. According to Toxic Sludge Is Good For You, a study of the public relations industry, Dr. Richard Burroughs was fired by the FDA in 1989 for testifying before Congress that his superiors had covered up evidence that Monsanto and other companies manipulated data on rBGH. Rache'ls Environment & Health Weekly reported that two of the Canadian scientists testified before a government board of inquiry that they were threatened with demotion if they stood in the way of Canada's speedy approval of rBGH.
As detailed in Toxic Sludge Is Good For You, a study of the public relations industry, Monsanto has actively spied on the anti-rBGH movement. Several women, posing as "typical" housewives who happened to favor the use of the rBGH, attended organizing several meetings in the late 1980s and early '90's, representing consumer organizations that turned out to be nonexistent.
At the other end of the spectrum, two Canadian government veterinary officials
claim that Monsanto offered them between one and two million dollars to help gain
approval for rBGH in their country. Monsanto says that the scientists mistook an
offer for funding for bribery.
Behind The Scenes At Fox 13
The lawsuit is not out of line with the pattern of major media to ignore or downplay
the rBGH controversy. According to the media watchdog group FAIR, with rare exceptions,
the U.S. media has failed to report on rBGH's health risks to humans and animals,
the Canadian bribery accusation, and the European Union's 1994 decision to ban rBGH
until the year 2000. Monsanto's hometown paper, the St. Louis Post-Dispatch, actually
spun the latter event as a victory for the company in 1994.
A Lack Of Credibility
For further information on rBGH:
Mothers & Others
Mothers & Others maintains a list of rBGH-free dairy products manufacturers.
Campaign for Food Safety (formerly the Pure Food Campaign)
Tell the FDA suspend Monsanto's license to sell rBGH. Write to:
Acting Commissioner Michael A. Friedman, M.D.
Tell Congress to investigate the FDA's safety review of rBGH. Write to:
Senator Patrick Leahy
Copyright © 1996. The Light Party.
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