by Gar Smith and Peter Montague
CANADA - In 1993, the US Food and Drug Administration had to decide whether to permit farmers to inject Monsanto's recombinant bovine growth hormone (rBGH) into dairy cows to artificially increase milk production. In 1990, the FDA had ruled that rBGH was "safe for human consumption."
Today, nearly everyone in US is effected by the FDA's decision - most of us are eating rBGH-treated milk, cream, cheese, yogurt, buttermilk, ice cream and baked goods. As Peter Montague writes in Rachel's Environment and Health Weekly [PO Box 5036, Annapolis, MD 21403, fax (410) 263-8944] "No other country besides the US has approved rBGH for use within its borders, though Monsanto has sought approval in Australia, New Zealand, the European Union and Canada."
In its attempt to force its way into Canada's markets, Monsanto set off a chain of events that has called into question the validity of the company's science and the credibility of the FDA.
The fuse was lit when Canadian government scientists were called in to review the science behind Monsanto's rBGH research. They found that up to 30 percent of lab rats fed rBGH for 90 days absorbed the genetically engineered material into their blood where it caused an antibody reaction. The researchers also found cysts on the thyroid glands of male rats given rBGH.
The Canadian researchers also noted elevated levels of IGF-I (an insulin-like growth factor) in the milk of rBGH-injected cows. Because IGF-I is shared by both cows and humans, the researchers cautioned that "many potential health concerns remain unresolved."
The Canadian government scientists concluded that "both procedural and data gaps were found which fail to properly address the human safety requirements of this drug under the Food and Drugs Act and Regulations."
The FDA's rules require that a drug must be shown to be safe for use in animals, but the Canadian researchers found numerous studies indicating that rBGH had caused "adverse effects in cows, including birth defects, reproductive disorders, higher incidence of mastitis, which may have had an impact on human health."
How, the Canadians wondered, could the US FDA have concluded that there were "no… clinical findings" in Monsanto's original study with rats and rBGH?
The startling answer came from John Scheid at the FDA's Center for Veterinary Medicine. The FDA never examined the raw data, Scheid told the Associated Press. "We do not have the data from that study." The FDA, Scheid stated, had relied entirely on a summary of the study provided by Monsanto.
In its 1990 ruling, the FDA stated that it "requires the pharmaceutical companies to submit all studies they conducted [and]… all the raw data from all safety studies that will form the basis of the approval of the product…." For some reason, the FDA failed to follow its own stated policy.
In its 1990 finding, the FDA declared that "if the initial toxicity study demonstrates that [rBGH]… is indeed orally active, additional testing may be required." If the FDA had actually reviewed Monsanto's raw data they would have seen that the product was in fact, orally active.
The Canadian researchers insist that their findings require that "long-term toxicology studies to ascertain human safety" and address the potential risks of "sterility, infertility, birth defects, cancer and immunological derangements."
Monsanto's application has been pending in Canada since 1990 and the corporation is impatient to proceed. According to Montague, Monsanto's application "has reportedly created political pressures on government scientists there to sidestep normal safety protocols."
The Canadian report also noted reports that "Monsanto pursued aggressive marketing tactics, compensated farmers whose veterinary bills escalated due to increased side effects associated with the use of [rBGH], and covered up negative trial results. All the four US manufacturers [Monsanto, Eli Lilly, Cyanamid and Elanco] refused to disclose the lists of their research grants to US universities." (A list of research grants could have uncovered further animal testing studies.)
Before they were silenced, the scientists told the Toronto Star that Health Canada (Canada's equivalent of the FDA) appeared "more concerned about pleasing the companies that submit the drug applications and are paying for their approval than they are about protecting health."
When Canadian lawmakers demanded to see copies of the Monsanto study containing the alarming side effects of rBGH, Health Canada officials turned it over but the critical information had all been "blocked out."
In the US, Consumer's Union is calling for a congressional investigation into the FDA's 1993 decision to approve rBGH. Meanwhile, in Canada, the scientists who authored the report exposing rBGH's risks have testified that they have been threatened and were told to alter the content of their report. (The scientists have been instructed not to speak to the press, but their uncensored report is posted on the Internet at www.nfu.ca/nfu/Gapreport.html)
Attempts by Earth Island Journal contributor Robert Cohen [Milk, the Deadly Poison] to obtain Monsanto's rat studies under the Freedom of Information Act have proven futile. FDA lawyers argue that releasing the study "would cause substantial competitive and financial harm to [Monsanto]." Montague, however, believes that the reason the FDA has resisted handing over the report is because the FDA "never possessed a complete copy of the study."
What You Can Do: Contact your representatives and the FDA [5600 Fishers Lane, Rockville, MD 20857, (301) 443-1544] to demand an investigation of the FDA's handling of the Monsanto application. Demand a recall of rBGH treatments until the FDA conducts a new and thorough review of the drug.