HOW BOVINE GROWTH HORMONE WAS REJECTED IN CANADA
by: Wolfson, Richard, Ph.D.
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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BOVINE GROWTH HORMONE: "CRACK FOR COWS"
by investigative reporters: Steve Wilson and Jane Akery for Fox TV, Tampa Florida
HEALTH EFFECTS ON COWS Bovine Growth Hormone (BGH) whose brand name is Posilac, is a genetically engineered hormone produced by the giant Monsanto chemical company. They are promoting it to farmers as "the single most tested new product in history specifically so you can increase your profit potential". Posilac increases milk production by up to 30% but shortens cows' lives by about two years. Twenty potential troubles are listed on the product-warning label. If untreated, the infection can get into the cow's milk, so farmers try to cure it by giving the cow shots of antibiotics, more drugs that can find their way into the milk on your table which could make your own body more resistant to antibiotics.
HEALTH EFFECTS ON HUMANS Apart from potential suffering for the animals, the biggest concern is what effect the drug might have on us and our children when they drink milk from treated cows. The growth hormone was approved by the FDA's Center for Veterinary Medicine as an animal drug, but many scientists say that since BGH affects the milk we drink, it should be tested as if it were a human drug. A human drug requires two years of carcinogenicity testing and extensive birth defect testing. BGH milk was tested 90 days on 30 rats before it was approved.
PUBLIC OPINION Demonstrations against the product three years ago showed Americans weren't very supportive of injecting dairy cows with synthetic growth hormones. A whopping 74 % of those questioned in a University of Wisconsin study released just last year, expressed concern about unknown, harmful human health effects which might not show up until later.
RISKS OF BGH There is highly suggestive, if not persuasive line of evidence showing that consumption of this milk poses risks of breast and colon cancer. Dr. Samuel Epstein, a scientist at the University of Illinois School of Public Health, is an expert on the environmental causes of cancer. He is opposed to Posilac (BGH) being given to cows that produce your milk on the basis of a body of peer reviewed research that raises some troubling health questions.
MONSANTO'S QUESTIONABLE ETHICS Monsanto, the giant chemical company that sells this synthetic hormone (previously manufacturer of Agent Orange and PCBs), rejects the concerns of scientists around the world and insists, "There is nothing to worry about".
Dr. William Bonmeyer, a scientist in Wisconsin, expressed concerns that "If we allow BGH to go on, I am sure that we are taking excessive risks with society". His concerns have sparked an inquiry by Congressman Scott Flug. Flug wants to know how the product was approved by the FDA for use in the U.S. three years ago, while a dozen European countries, Canada and New Zealand, have blocked its use.
George Wald who received a Nobel Prize in physiology and medicine said, " Recombinant DNA technology, which is genetic engineering, faces our society with problems unprecedented not only in the history of science but life on earth. It places in human hands the capacity to redesign living organisms, the product of some three billion years of evolution. Up to now living organisms have evolved very slowly and new forms had plenty of time to settle in. Now whole proteins will be transposed overnight into wholly new associations with consequences no one can foretell, either for the host organism or their neighbours."
Dr. Richard Lacey is a very, very distinguished medical doctor, microbiologist and professor of food safety at Leeds University. He became famous when he predicted mad cow disease more than seven years ago. He stated, “It is virtually impossible to even conceive of a testing procedure to assess the health affects of genetically engineered foods when they are introduced in the food chain; nor is there any valid nutritional or public interest reason for their introduction. There is no practical value for genetically engineered food.”
Dr. Joseph Cummins, who is a very well recognized environmentalist in North America, is one of the few scientists in Canada who speaks out against genetic engineering. Most scientists won't speak out against genetic engineering because they get their research money from industry and could be very severely reprimanded by their department; they could lose their research grants, their laboratories and funding. Dr. Cummins has been severely criticized and ridiculed, but recently there have been indications that he could be right. He stated, "Perhaps the greatest threat from genetically altered crops is the insertion of modified virus genes into the crops. Modified viruses could cause famine by destroying crops, or cause human and animal diseases of tremendous power. When they send in a foreign gene they put it on the back of a virus so the virus can take it right into the DNA, but if that virus mutates, it could result in a deadly or dangerous virus that could result in new injurious diseases, new viruses, and new pathogens."
Dr. Pusztai is a very prestigious scientist at the Rawat Institute in Aberdeen, Scotland. He announced to the press that he had genetically engineered some potatoes which had caused internal organ system damage and immune damage to his test animals. Within a few days, he was ridiculed, had lost his job, and was forced into retirement. His boss announced on the news that he had made a mistake, but several dozen scientists around the world came to his support, studied his research and said that he was correct, that these genetically engineered potatoes were dangerous. Earlier this year, he actually testified at the House of Commons in London, where they are now doing a major inquiry.
Dr. Irwin Chargoff, who is regarded as the father of modern molecular biology (genetic engineering) stated, "You can't recall a new form of life. It will survive you and your children and your children's children. It is an irreversible attack on the biosphere, something unheard of, unthinkable to previous generations. I could only wish that mine had not been guilty of it.”
Britain’s Prince Charles is strongly opposed to genetic engineering, and he has stated that “Genetic engineering is like playing God.” (see www.princeofwales.gov.uk/forum)
See August 1999 newsletter for genetic engineering websites, Richard Wolfson's article, The Risks of Genetically Engineered Foods, and 'How We Can Protect Ourselves'.
Issue 9 |