Chapter 8 Got Hormones? Engineering the Nation's Milk Supply Long before the first GM food hit the shelves and far before ''Frankenfood'' frenzy erupted in Europe, transgenic technology had made its way into one of America's most sacred and wholesome foodstuffs: milk. Feeding off the 1980s biotech blockbusters, symbolized by the development of recombinant insulin in the human drug realm, several large multinationals--including Monsanto, Upjohn, Eli Lilly, and American Cyanamid--had begun to dream about making bacteria pump out hefty doses of a recombinant growth factor called bovine somatatropin (rBST--also known as recombinant bovine growth hormone, or rBGH). It was rumored that when fed to cows, this factor would dramatically increase milk production. Company executives reasoned that large vats of this high-octane hormone could spell millions in profits--$500 million, to be exact, based on preapproval anticipated sales figures reported in the Wall Street Journal in 1989. Tampering with a ''Sacred Cow'' Indeed, the genetic recipe for rBST had already been patented in 1980 by Genentech, the company that was about to put biotech venture capital on the map with Humulin, the recombinant human insulin drug that would debut in 1982 as the first recombinant human pharmaceutical to be approved by the Food and Drug Administration (FDA). But with its agricultural reverberations, rBST was an obvious piece of intellectual property that belonged in Monsanto's stable, and in 1981, the company had licensed the patent rights from Genentech. A few years after that, Monsanto began largescale trials treating cows with this magic bullet that it hoped would greatly up the ante on milk production. The potential to use naturally occurring growth hormones to increase milk production in dairy herds had been recognized as early as the 1930s, but the labor and expense of extracting the relatively small quantities of BST present in bovine pituitary glands made it prohibitive for wide-scale use. But five decades later, as the biotech bubble began to swell and new tricks and tools had come available, researchers revved their recombinant engines at the thought of churning out artificial hormones that might power the dairy industry. The potential to produce rBST on a massive scale and use it to supercharge the metabolism and milk production of America's dairy cows in a big way looked like an opportunity just begging to be milked. By 1985, Monsanto had secured permission from the FDA to conduct large-scale field trials of the hormone, and cows reacted predictably, increasing their milk output on cue. But as with so many of their GM food products, Monsanto lacked foresight and failed to adequately, or perhaps accurately, consider consumer revolt as one potential outcome. Brashly building its rBST factory in Austria, Monsanto optimistically anticipated rapid approval and adoption in Europe. In the United States, the company touted the drug's supercharging ability to skyrocket production to increases of 25 or even 40 percent over already elevated levels of milk output in the country--forgetting that a growing glut of dairy surplus was driving prices down and hurting farmers at the time. Indeed, in those days, it seemed that almost everyone except for Monsanto was beginning to question whether the world, or at least the United States, needed more milk. Milk production in the country had steadily risen since 1975, while consumers had held their intake steady. That had led to an ever expanding government buy-back program, costing taxpayers billions in purchase and storage costs for the surplus. In 1985, the same year in which Monsanto trooped out its field trials of rBST, the Food Security Act was adopted by Congress in an attempt to diminish the price supports that were drowning the program financially. Dairy herd sizes were cut, often dramatically, through such means as culling of overproductive herds. While Monsanto naively assumed that the U.S. obsession with growth at any cost would be a vision that dairy farmers shared, for many--particularly smaller independent dairy farmers--such a supposition shot fear rather than enthusiasm through their communities. This was particularly the case in Vermont, a dairy-rich state that supplies almost half the milk for all of New England, and where until the last century cows outnumbered humans. With their smaller-sized farms and higher production costs, farmers there had been particularly hard hit by the leveling off of price supports in the face of rising costs. Vermont was, inevitably, also one of the states where Monsanto had contracted with university researchers to conduct safety and efficacy trials for rBST. The practice of involving university scientists in commercial product trials, particularly in the pharmaceutical field, has increasingly come under scrutiny for obvious reasons. When scientists conduct research in the public domain, their investment in the outcome of an experiment is relatively limited. In such a context, science is practiced as a portal to increasing objective knowledge about the world, and researchers are inclined to publish their results, regardless of outcome. But when private interests fund and thus indirectly control the research process, bias can creep in. At best, experiments can be abandoned and questions left unanswered if the results of such forays threaten to turn up incriminating evidence. At worst, critical components of the scientific method can be compromised, with data doctored or deleted and important results suppressed. In such enterprises, when companies control or conduct reviews of research prior to submission for publication, the ''publish or perish'' mandate so often present in academic science can be turned on its head. Documented cases of research bias in public-private academic collaborations in the human drug realm are increasingly being uncovered. Anecdotal allegations that scientists participating in safety and efficacy trials for Monsanto's rBST were encouraged to shift or suppress their research questions in a certain direction or lose favor and funding from the company have made their way into the grapevine of gripes against rBST. Whistleblowers and Suppressed Evidence At the other end of the spectrum are the rare scientist-activists who, when presented with data that disturbs them, decide to take their crusade to a personal level, potentially damaging their reputation and opening them up to charges of bias in the opposite direction. Sometimes, their commitments to their cause turn out to have been harbingers well heeded. Such was the case with Rachel Carson, the doyenne against DDT, or Stanley Prusiner, the proponent of prions as the causative agent of mad cow disease, who was once shunned but went on to win a Nobel Prize. But in other less celebrated cases that the world seldom hears about, such scientists are moved slowly to the sidelines, relegated as renegades to objectivity and the scientific method and often driven out by the detractors they targeted. It did not take long for this scenario to develop around the approval of Monsanto's rBST. The first of these whistle-blowers, who would follow the latter path into scientific oblivion, was a Chilean scientist named Maria Lyng who worked in the agricultural school at the University of Vermont (UVM). In a news article that appeared in the British magazine New Scientist in early 1992, Lyng was reported to have been dismissed from her research post at the university after ''asking awkward questions about the effects of BST.'' Lyng's research had focused on identifying the genetic basis for stillborn and aborted calf fetuses, and in her work, she had asked to obtain data and samples from the rBST studies, which she had heard were in some cases turning out aborted and deformed calves. Shortly thereafter, she was fired from UVM. But Lyng did not leave quietly. Instead, she passed on critical data she had obtained relating to the rBST trials at the university that ultimately would provoke controversy. In 1991, Robert Starr, chairman of the agricultural committee of the Vermont state legislature, had requested data on the rBST studies performed at the university. They had been handed over by scientists, but not before the identifying numbers had been removed from the data, obscuring any conclusions that might be made between rBST and birth defects in a cow's progeny. When pressed, the university conceded that Monsanto had made them do it. The research contract between the university and the company clearly spelled out Monsanto's right to veto the release of any data for a year following the conclusion of the study. But Lyng, disgruntled and convinced that there might be a relationship between rBST use and miscarried and deformed calf fetuses, was able to obtain the data with the identifiers. She passed the information on to a local activist group, Rural Vermont, as well as to the Vermont House and Senate agricultural committees. Monsanto Concedes on Mastitis After receiving the data, Rural Vermont commissioned a report by Andrew Christiansen, a state representative and an active member of the rBST debate through his membership in the state's House agricultural committee. The data were a bit fishy, but however they were analyzed, a significant percentage of the calves from rBST cows or their progeny appeared to be victims of birth deformities. Their abnormalities included a ''bulldog''-type dwarf fetus that was aborted at six months; a ''dipygus'' calf possessing a double pelvis and extra legs, which caused difficulties during birth leading to the death of the mother; and an ''encaphalocoele'' fetus born to an untreated daughter of a rBST-treated cow that developed a large fluid-filled cavity in its head. These were gross and obvious abnormalities, not the kind often seen in short succession, if ever, in a dairy operation. Certainly the odd birth with a twisted leg or misshapen hoof might turn up every now and then on a farm, but the severity and phenotype of these abnormalities were, well, just that: far from normal. The data appeared to associate more than severe birth defects with rBST treatment. There were also more minor yet still significant health ailments that plagued treated cows in the study. The report commissioned by Rural Vermont indicated the presence of various problems in treated cows including increased incidence of uterine infections, hoof rot, foot and leg injuries, and ketosis, a condition that is characterized by partial anorexia and depression and is accompanied by the presence of byproducts of fat breakdown, called ketones, in the animal's milk and urine. A detailed analysis of the data by David Kronfeld, an agricultural and veterinary expert at Virginia Tech who was commissioned by the Vermont state legislature, identified three statistically significant conditions in the rBST-treated cows: an increased incidence of retained placenta and ketosis, an elevated number of dead and deformed calves, and a higher number of ''beefed'' cows removed from the herd and sent to the slaughterhouse. When the Rural Vermont conclusions were released, it triggered a news flurry, especially in key dairy states. Then two members of the U.S. House of Representatives asked the FDA to review the case and compare data submitted for review by Monsanto with the results uncovered by Rural Vermont. However, the numbers were small, and the way that Monsanto and UVM had reported the results of different studies was confusing. The data that had been reviewed by the FDA was different from the data from experiments leaked to Rural Vermont, even though all of the experiments had been conducted at UVM on behalf of Monsanto. What was clear, though, however the data were interpreted, was that the cows given the experimental rBST treatment had a higher likelihood of health problems, including a fourfold increase in the frequency of mastitis, an infection of the udder, and a lesser likelihood of reproductive success. Following this revelation, after previously pleading no difference in bovine health relating to rBST treatment, scientists from UVM and Monsanto made a joint public confession in an article in the Journal of Dairy Science that in their experiments, rBST treatment did significantly increase the occurrence of mastitis in dairy herds. This had important implications both for the health of the herd and because mastitis is usually treated by intramammary antibiotic infusion, which is a direct flushing of antibiotics into the udder. This in turn prevents that cow from continuing to produce commercial milk supplies for a set period after treatment; affected individuals must be marked in some way to prevent their milk from entering the holding tank. If antibiotic-tainted milk accidentally enters a supplier's milk shipment, the producer risks fines or losing its permit to ship Grade A milk. From a health standpoint, antibiotics are just one implication of mastitis; cows with mastitis typically produce clotted or flaky milk and accumulate large amounts of pus at the site of infection. (While public aversion to antibiotics in milk is high, consumer sentiment surrounding pus in milk is even more unrelenting.) Later, once rBST had been approved and was in widespread use in the United States, the animal rights activist group People for the Ethical Treatment of Animals (PETA) would install a series of billboards mocking the dairy industry's ''got milk?'' campaign, inquiring instead if milk drinkers had ''got pus?'' in their rBST-sourced milk. Of course, mastitis is not limited to cows being given rBST injections. Any cow can fall prey to mastitis, especially if herd hygiene is not adequately managed or if milk capacity dramatically increases. This was one of Monsanto's arguments against a direct link between rBST treatment and mastitis: Cows treated with rBST produced far more milk than their untreated counterparts, and thus one would expect to see a higher incidence of mastitis, due not necessarily to the drug but to the mere fact that they were producing more milk--a known risk factor for mastitis in the dairy industry. But the argument was circular, and experimentally, the incidence of mastitis in the group treated with rBST was statistically so much higher than the untreated control group that Monsanto had to concede the link. Today, package labeling for Posilac--the trade name that rBST is marketed under--is required to contain the indisputable warning ''Cows injected with Posilac are at an increased risk for mastitis (visibly abnormal milk) and may have higher milk somatic cell counts. Have comprehensive mastitis management practices in place on your dairy before using Posilac.'' Excerpted from Food Fray: Inside the Controversy over Genetically Modified Food by Lisa H. Weasel . Copyright (c) 2009 Lisa H. Weasel. Published by AMACOM Books, a division of American Management Association, New York, NY. Used with permission. All rights reserved. http://www.amacombooks.org. Excerpted from Food Fray: Inside the Controversy over Genetically Modified Food by Lisa H. Weasel All rights reserved by the original copyright owners. Excerpts are provided for display purposes only and may not be reproduced, reprinted or distributed without the written permission of the publisher.
