Monsanto's premier biotech product faces a tough sell abroad and
a rocky future in the U.S.
by Shelley Alpern, Sr,. Research Analyst
In the recent box office hit Snake Eyes, corporate scientists collude with government bureaucrats to doctor missile system test results, risking the lives of the American people for profit. In real life, corporate interests are colluding with government bureaucrats to risk the health and lives of Americans to increase milk profits.
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.
Although the warning label on Posilac lists twenty possible adverse side effects, Monsanto maintains that cows are unaffected by the increased milk production because the product provides nutritional regulation that signals the "appropriate use of nutrients thus preventing cow burnout." Any problems that may have been observed, says the company's web site, are due to other aspects of herd management. However, substantial evidence documents adverse health impacts on cows include shortened lives, birth defects, weight loss, reproductive disorders, and higher incidences of mastitis, an infection which inflames the udder.
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
Public health concerns about the safety of rBGH go back to at least 1988, when British and American scientists raised questions about high levels of IGF-1 levels in cows treated with the hormone. Monsanto attacked the findings vigorously, insisting that the hormone would be completely broken down by digestive enzymes.
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
According to numerous surveys, public skepticism remains high about the safety of bioengineered foods. In response, Monsanto has waged an extremely aggressive multi-front campaign to convince the public that Posilac is safe and to intimidate critics and would-be whistle blowers.
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
In Tampa, Florida, two award-winning investigative reporters have filed a lawsuit charging Fox 13 (WTVT) with violating the state's whistle blower law by firing them for refusing to broadcast false reports about rBGH. Jane Akre and Steve Wilson's say Fox was pressured by two threatening letters from Monsanto that insisted the station water down a four-part series scheduled to air in February 1997. The broadcasts looked at the health risks to humans and animal and provided proof that supermarket chains Publix and Albertsons and the Fleming Companies, a huge wholesaler of dairy products, had reneged on pledges not to sell rBGH-treated milk until the product had gained wide consumer acceptance. The companies now acknowledge that because it co-mingles milk from both treated and untreated cows, they cannot certify that any milk is hormone-free. Akre had visited seven dairy farms at random and found that all were using Posilac. The lawsuit says Akre and Wilson were fired after nine months of unsuccessful re-writes failed to satisfy Fox's management. "We set out to tell Florida consumers the truth a giant chemical company and a powerful dairy lobby clearly doesn't want them to know_.As we've learned the hard way, [that's] something you can be fired for these days whenever a news organization places more value on its bottom line than on delivering the news to its viewers honestly."
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
In addition to everything else, Monsanto's checkered history makes it hard to give the company's scientific claims the benefit of the doubt. Monsanto is the same company that argued successfully but wrongly to the government that both PCB's and Agent Orange were not harmful to humans or the environment. Recently revamped as a "life sciences" company, Monsanto spun off its chemical business into a separate publicly-traded company, Solutia, in 1997. But it has yet to shed the decades' worth of suspicion that remain while attempts to become the world's preeminent promoter of genetically engineered and scientifically controversial agricultural products. [opt: Last summer, the Grameen Bank of Bangladesh, the pioneering development fund that has provided billions in microloans to entrepreneurs in South Asia, was forced to back out of a partnership with Monsanto by a barrage of public criticism.] Ironically, the new Monsanto has embraced the rhetoric of sustainability in its public statements and documents. But with Posilac being used by only 4% of American dairy cows, it is not clear that Posilac, let alone Monsanto, is a sustainable enterprise.
For further information on rBGH:
Mothers & Others
40 West 20th Street ï New York, NY 10011-4211 ï (212) 242-0010
Mothers & Others maintains a list of rBGH-free dairy products manufacturers.
Campaign for Food Safety (formerly the Pure Food Campaign)
860 Highway 61 ï Little Marais, Minnesota 55614 ï (218) 226-4164
Tell the FDA suspend Monsanto's license to sell rBGH. Write to:
Acting Commissioner Michael A. Friedman, M.D.
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857