At that time there was little commercial interest because the only way to obtain somatotropin was to extract and purify it from animal pituitary glands, a process that was prohibitively expensive. The development of modern biotechnology techniques in the 1970s enabled scientists to produce somatotropin, human and otherwise, in the laboratory. This made it economically feasible to study the effects of bovine somatotropin (BST) on milk production in cows, with the first reports appearing in the literature in 1982. Laboratory-produced somatotropin is called recombinant somatotropin. Because BST is a type of growth hormone, it is also referred to as recombinant bovine growth hormone. BST is also referred to as rBST, bST, BGH, and rBGH. The company that produces BST, Monsanto, markets it under the trade name Posilac.
According to proponents of BST, scientists worldwide have conducted more than 2,000 studies on BST. These studies have clearly shown the efficacy, safety, and benefits of BST use in dairy production. Before approving BST, FDA required companies to prove that the products of BST-supplemented animals are safe for human consumption, that BST is safe for the animals, and that BST is safe for the environment. Pro-BST scientists claim that studies show BST does not adversely affect the health of treated cows, does not change the composition of milk, and does not pose any risk to humans. Supporters claim that the public has been deliberately misled by groups who oppose the use of animals for food, want to promote organic foods, or have their own anti-industry, anti-technology agenda.
In light of the continuing debate and possible new evidence, in 1999 FDA re-evaluated BST in the most extensive post-approval study ever conducted on any animal product in the United States. The conclusion was the same-that BST is safe for humans and animals. Opponents of BST claim that there has been a major hijacking of the scientific and regulatory apparatus by Monsanto. By virtue of their size and wealth, big multinational companies such as Monsanto are able to exert their influence on news media, government agencies, and academia to portray their products in a good light. As evidence of this, critics point to the sudden cancellation (and subsequent firing of the producers) of a Fox News documentary that was to reveal negative aspects of BST;
Monsanto's threats of lawsuits to school boards if they banned BST from school cafeterias; aggressive lobbying against BST labeling laws in Congress and in individual states; and firing of scientists if they expressed concerns about the safety of BST. BST critics claim that Monsanto influenced and manipulated rulings from federal agencies responsible for granting BST approval. As an example of the close working relationship between industry and the government, they cite a former Monsanto researcher who worked on BST and also had major responsibility for crafting the official FDA position on BST. Opponents allege that FDA never actually examined data from a Monsanto study, but instead based their safety assessment on Monsanto's summary of the study. Furthermore, it is claimed that Monsanto suppressed unfavorable results from studies, blocked publications from other scientists that showed negative results, selectively emphasized positive points, and compensated farmers who had increased veterinary bills from using BST on their cows.
This range of influence extends to Canada too, as one of the experts assigned to review the safety of BST previously worked as a consultant to Monsanto. In Canada, several scientists claim they were pressured by supervisors to approve BST even though they had reservations about its safety. Critics claim that the Canadian government might have been influenced to approve BST because one of the experts assigned to review its safety had previously worked as a consultant to Monsanto. Anti-BST activists allege that Monsanto offered the Canadian government between one and two million dollars if Monsanto received approval to market BST in Canada without having to submit data from any further studies (Anderson 1999). This is an allegation that Monsanto firmly denies. BST opponents believe that, as with other food biotechnology products, BST is an ill-advised experiment with American consumers as the guinea pigs, and that release of such a substance has major potential health risks for the entire U.S. population.
In 1993 FDA approved BST for commercial use. It was the first biotechnology product approved for animal use, and it ushered in the whole era of food biotechnology. Although the United States and 25 other countries have approved the use of BST, it remains banned in Canada. The European Union (EU) has imposed a moratorium on its use. Scientists from the Food and Agriculture Organization of the United Nations could not reach a consensus on BST when they met in 1999. Debate on the safety of BST still remains strong. Issues center on human health, animal health, and socioeconomics.
