Health & Nature

How Bovine Growth Hormone Was Rejected In Canada

Prior to1980, Bovine Growth Hormone (BGH) could only be obtained from cows, but with the development of genetic engineering, scientists were able to genetically engineer bacteria that were able to produce BGH in the laboratory. Even in the mid-eighties, scientists who were developing BGH were very concerned and said we should have long-term testing before we start using this in cows. When we inject a hormone into an animal or a human, it affects other hormones and it can have a whole cascade of effects which no one really knows. In Europe, hormones are not permitted to be used in cows; so Monsanto decided to change the name of BGH to bovine somatotropin (rBST) which was created to avoid using the word ‘hormone’.

In 1988, about four different companies applied in Canada for the approval of bovine growth hormone. One of the scientists, Dr. Shiv Chopra in the human safety division of the Bureau of Veterinary Drugs, requested more information on the long-term effects on human health, particularly on the effect on the immune system and on birth defects, but no long-term studies had been conducted. The only research that was done, was a 90-day study on 30 rats. And even that study was not available to the scientists. So Dr. Chopra submitted a request for more research to ensure that it was safe, and the main effect of his request was that he was taken off the BGH review, and all of the other scientists in the Bureau of Veterinary Drugs were also taken off the review of BGH. It seems that industry pressured Health Canada and the only people who were allowed to do the review of BGH were the upper level management. The fellow, Monseignon, the chief of the Human Safety Division approved it, going against the advice of his own scientists, even though the scientists said it wasn’t safe for humans because the safety tests weren’t done to prove it which is a very scary thing – that he could veto his own scientists. That happened around 1990.

Health Canada based their approval solely on an abstract of a study published in Science magazine by two American scientists who worked for Monsanto. This was the 90-day study of 30 rats. During the whole time period, from 1994 to 1998, the scientists at Health Canada couldn’t even get a look at it because the complete study was kept locked up and kept secret. By law, the scientists in Health Canada are supposed to study the research before the drug is approved.

In 1993, when BGH was approved in the U.S. it was approved on the basis of the same limited information in this journal abstract. Upper management level scientists at Monsanto claim that since BGH is a protein, it gets digested and broken down so there won’t be any physiological problems. However, within the last year, the scientists at Health Canada were able to obtain the whole study. Research on the animals showed that BGH does pass through the gut, the animals had increased antibody levels, and at the same time there was damage to various organs such as cysts in the thyroid and inflammation of the prostate and other glands.

There are two levels of approval. First there is approval for human safety and then there is approval for animal safety. After BGH was approved in the Human Safety Division in Canada, against the advice of the scientists who got vetoed by their boss, it was passed onto the Animal Safety Division. In the Animal Safety Division it wound up in the hands of another scientist, Margaret Hayden, and the people who passed it along to her didn’t realize she had a conscience. So she started looking at the results of the research that was given to her (industry does the research, and they pass it along to Health Canada). She found problems such as mastitis or inflammation of the udder, joint problems, deformed offspring, and a decrease in lifespan of up to two years. So Dr. Margaret Hayden recommended it not be approved. What do you think happened to Dr. Margaret Hayden, after she made this recommendation? She got dropped. She was never allowed to study BGH again.

Margaret Hayden was one of the scientists who were at a meeting with Monsanto officials when they offered Health Canada one to two million dollars to approve BGH without any further studies. Fifth Estate, Canada AM, and several other TV stations have confirmed this by talking to other people present at the meeting. Len Ritter, the Director of the Bureau of Veterinary Drugs tried to pressure Margaret Hayden to approve BGH conditionally, and subsequently keep records of the effects of the hormone on the cows and the humans. Margaret responded that it’s illegal to approve a drug, and allow it on the market before it is shown to be safe. Then what happened to Margaret was very scary, to say the least. A few weeks later, Margaret came in Monday morning and realized someone had stolen all her records on Bovine Growth Hormone, research showing that it produced lameness in animals and increased mastitis, as well as the notes she had taken at the meetings when Monsanto offered one to two million dollars to Health Canada.

Back in 1996, scientists in the Bureau of Veterinary Drugs filed a grievance that they were being pressured to approve drugs against their professional judgement, that they are being coerced and threatened. These are scientists who are just trying to protect our health. Another hormone, Revlor H, is injected into cattle to get them to produce more meat. Margaret Hayden looked at the research on Revlor H and found enlarged ovaries, uterus and prostate, and shrunken thymus glands, which were very extreme warning signals. She tried to stop it and her boss, again, vetoed her and approved it anyhow. Another scientist agreed that it shouldn’t be approved, and Don Landry, the Head of the Bureau of Veterinary Drugs said, “So what. They are just going to be slaughtered.” The scientist said, “What do you mean? They are going to be eaten.” There is some extreme financial pressure being exerted by industry on Health Canada.

Early this year, the Canadian Senate Agriculture Committee was conducting its own evaluation of BGH, and when they heard Margaret Hayden’s reports of bribery and of stolen documents, they were completely amazed. They didn’t believe they were in Canada. When the Senate Agriculture Committee gave its interim report on BGH, one of the main recommendations was that there should be a very deep investigation of the relationship between Health Canada management and industry, because they are just too closely intertwined. Industry gives Health Canada money to do research. As a result, Health Canada looks on industry as its client and wants to keep its client happy, so it wants to process its requests for drug approvals very quickly. And that is basically what is going on. Finally, at the beginning of 1999, Health Canada decided that it couldn’t push BGH through, but they still wouldn’t admit that there were safety problems for humans, because they had already announced back in 1990 that it was safe.

But that’s not really the end of the story, because it is still being used in the U.S. The Consumer Union, Michael Hanson, and various public interests groups want an investigation into the approval process. It seems their approval process is what they call a ‘revolving door policy’. Margaret Miller who did much of the research on BGH at Monsanto, was then hired by the Food and Drug Administration (FDA) of the US government, and then she ended up approving her own research on BGH. So it seems the whole approval process and the relationship between industry (particularly Monsanto) and government health departments both in Canada and in the U.S. are slimy.

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