"Rural Vermont, a nationally known farm advocacy group, has published two investigative reports on bovine growth hormone, (rBGH or rBST), a synthetic hormone injected into cows to force them to make more milk." said Jenny Nelson, Co-Chairperson of Rural Vermont. "Our reports come on the heals of more bad news for the controversial drug. Information released last week by the Federal Food and Drug Administration (FDA) chronicles an increase in serious health problems affecting dairy cows treated with the hormone. The FDA's latest report adds further weight to the conclusions of the report authored by Andrew Christiansen that "Congress and the President should rescind FDA's approval of rBGH until its safety can be assessed." The other bad news for Monsanto was that a nationwide poll found that many farmers who have used the drug now are rejecting it," Nelson said.
"With all the cracks and fissures of the approval process clearly visible -- from the unprecedented number of adverse effects on cows to the universities' cover up of test results -- it is clear that rBGH is a product in its second stage of testing. Unfortunately, it will be consumers with their health and farmers with their livelihoods who will be the guinea pigs at risk." said Andrew Christiansen, author of the 30 page illustrated report entitled: Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval: The Story Behind the Rush to Bring rBGH to Market.
The report examines the pre-approval trials on University of Vermont test herds and finds that the rBGH review process was marred by serious flaws, conflicts of interest, violations of ethics rules, and illegal leaking of proprietary information by the FDA throughout the review process.
Further reinforcing concerns in the United States about the drugs safety, last week Health Canada directed Monsanto, the producer of Posilac, to do in-depth studies of drug efficacy and animal health. Canada has had a moratorium on rBGH use.
The second report by Mark A. Kastel, Director of Governmental Affairs of the Wisconsin Farmers Union, reports on herd health problems including interviews and profiles of individual dairy farmers who have had "BGH disasters" on their farms. The report is entitled Down on the Farm: The Real BGH Story: Animal Health Problems, Financial Troubles. Kastel's 17 page illustrated report quotes a number of farmers who have had emotionally and economically devastating experiences with the use of bovine growth hormone on their herd.
Jay Livingston, a New York farmer who has had cows develop problems with rBGH said, "When we started to develop problems, Monsanto came out to the farm and told us we were the only ones having problems. They blamed us and had every excuse...but totally rejected BST had any relationship to our problems."
Last week unedited data was obtained from the Federal Drug Administration through a freedom of information request made by the Wisconsin Farmers Union based in Chippewa Falls, WI. Hundreds of farmers who have tried the controversial bovine growth hormone continue to report serious health problems with their animals. To date, thousands of individual cows on over 1300 farms have been affected. The current data Kastel extracted from the FDA updates earlier FDA reports and adds to the many stories that have been personally called in to the Farmers Union BGH Hotline (800-272-5531).
A recent national poll conducted for Dairy Today Magazine cited unprofitability and health problems with cattle as the primary reason many farmers have quit injecting the hormone. The poll indicates that Monsanto reached a peak of only 20% of market usage before 40% of those farmers quit. The poll also said 87% of farmers who haven't yet tried rBGH "would never use it". Also according to the poll, only 12% of farms are still using the product and many of these appear to have reduced their purchases radically. More ominously for Monsanto, only 5% of non-users said they planned to use it in the future.
"It appears that Monsanto doesn't have many farmers left who might be willing to gamble with the health of their cows and their farm's financial future," Kastel deduces.
Press conferences will be held by the Pure Milk Campaign, a national network of farmers in various parts of the country on Friday October 13, 1995. The conferences will focus on the horrors that have resulted from thousands of cows being injected with the controversial growth hormone, the faulty approval process and lack of follow up enforcement by the FDA.
The report Summary, attached, may be released and quoted from on that day. This Summary
report is also available on the Internet's WWW at:
http://plainfield.bypass.com/~N_E_Research/bgh.html. The full reports are available from
Rural
Vermont
(802-223-7222 phone, or 802-223-0269 fax).
Bovine growth hormone (BGH; also known as recombinant bovine growth hormone, rBGH, recombinant bovine somatotropin, or rBST) is a synthetic, genetically engineered copy of a cow's naturally occurring growth hormone that is injected into dairy cows to increase milk production. After years of debate and controversy, the Federal Food and Drug Administration (FDA) gave the Monsanto corporation approval to market the first BGH product under the trade name "Posilac" in late 1993, and the drug went on sale in February 1994.
Even a small increase in milk surpluses causes a big decline in family dairy farmers' incomes. Milk production was up sharply in states where BGH sales were highest in 1994, depressing milk prices nationally.
Ironically, Monsanto's own product package insert -- required by the FDA -- cites 21 animal health problems for which cows are at increased risk with BGH; including increases in mastitis (udder disease), reproductive problems, use of medication to treat sick cows, digestive problems, enlarged hocks and lesions and foot problems, as well as swellings at the injection site. FDA documents show that cows injected with BGH are 79% more likely to contract mastitis. In 1991 Rural Vermont's report on Monsanto's BGH test herd at the University of Vermont found the same kinds of problems identified by the FDA, plus an alarming number of dead and deformed calves born to cows treated with BGH.
A 1994 Gallup poll showed consumer awareness of BGH went from 28% in 1993 to 63% since the drug entered the market in February 1994. Mona Doyle, a nationally noted food industry pollster, says that milk will lose market shares to juices and other drinks because 80% of consumers remain concerned about BGH, with 40% "very concerned." Dairies selling BGH-free milk have reported increases in sales of up to 10-25%.
The Congressional General Accounting Office (GAO) and Consumers Union have charged that increased animal health problems translate into increased use of antibiotic drugs, including so-called "extra-label" drugs (drugs not approved for normal use on cows but tolerated by the FDA when prescribed by a veterinarian -- stronger extra-label drugs are sometimes used when other drugs have failed). Because extra-label drugs are not monitored or tested for by the FDA, their use can be considered a serious consumer health issue.
Concerns have also been raised about IGF-1 (insulin-like growth factor-1), the molecule that transmits the effects of BGH in cows. IGF-1 is identical in cows and humans, and there is evidence that IGF-1 levels are increased with the use of BGH. Some scientists claim there may be a link between elevated levels of IGF-1 and the incidence of breast cancer in women and other serious health problems.
BGH is the first of many biotechnology products with profound implications for the future of our farm and food system. Products nearing the market include:
Is bovine growth hormone a safe product for cows? Is it -- as Monsanto, its only licensed manufacturer, has insisted in an ever-more aggressive marketing campaign -- here to stay on the nation's dairy farms?
Two special reports just published by Rural Vermont examine these vital questions with a close eye on the facts actually reported by researchers and farmers who have used BGH. Together, the two reports make it clear that the alarming herd-health problems which first surfaced when BGH was tested have since been experienced by dairy farmers across the country -- many of whom have quit using BGH in dismay after suffering serious losses in herd health and farm income.
The first of the new reports, Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval, re-examines the testing and evaluation process that led up to BGH's approval in 1993 by the Food and Drug Administration. Written by Vermont State Representative Andrew Christiansen, the report tells of the concerns first raised by Rural Vermont's 1991 expose on herd testing at the University of Vermont -- and it recounts several instances where troubling test results were suppressed by Monsanto and ignored by the FDA.
The second report, Down on the Farm: The Real BGH Story, picks up the tale with dozens of reports that have come into the Wisconsin Farmers Union's BGH animal health hotline, and been uncovered by the press, since the drug has been on the market. Author Mark Kastel, director of governmental affairs with Wisconsin Farmers Union, quotes farmers in Wisconsin, New York, Texas and Florida, many of whom had won dairy herd quality awards before using BGH, but all of whom developed serious problems after they began using the drug.
Many farmers who have tried BGH, according to Kastel's report, have seen their herds develop widespread and virulent outbreaks of mastitis, sharply higher somatic cell counts (an indicator of udder health and mastitis), deaths from ruptured blood vessels -- some within hours of BGH injections -- multiple abortions, lumps and open sores at injection sites, and/or hoof problems. Many of those side effects are forewarned on Monsanto's own product insert label for its BGH product; many were also forecast in the preapproval testing.
Some farmers have actually reported that BGH had a negative impact on milk production in some cows; others have said that overall production has been lower since they quit using the drug than before they tried it. Some farmers who contacted the hotline said the financial and emotional impacts of these troubles have been enormous, sometimes threatening their farms' survival.
For all those who care about the nation's dairy farms and dairy farmers, these two new reports make powerful reading. This publication summarizes both reports briefly. (Please use the order form near the end of this report to order multiple copies of this report and/or copies of the full length reports.)
Vermont State Rep. Andrew Christiansen of East Montpelier wrote the 1991 Rural Vermont expose that first uncovered severe health problems in the bovine growth hormone test herd at the University of Vermont (UVM). Christiansen's new report, Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval, reviews the original expose and picks up where it left off, recounting what happened when some Vermonters uncovered facts about BGH testing that those investing in the drug did not want the public to know.
As the new report makes clear, preapproval testing of recombinant BGH provided quite a bit of information about the hormone's potential dangers to dairy cows -- yet Monsanto and its research client, the University of Vermont, consistently and repeatedly failed to disclose adverse testing results that might have slowed the rush to approve the new drug -- even when Rural Vermont, Vermont State legislators, and the Congressional General Accounting Office asked them to make data available for review.
By 1994 Monsanto had spent an estimated $800 million on recombinant BGH. In order to win the FDA's approval for commercial marketing of the drug and begin earning back their investment, Monsanto (and three other drug companies still seeking approval from the FDA) began contracting with universities in the early 1980s to perform the research required by the FDA. This research testing process began in 1981 and concluded with FDA's approval of BGH in November 1993. But Christiansen's report finds that the BGH review process was marred by serious flaws, conflicts of interest, violations of ethics rules, and illegal leaking of proprietary information by FDA throughout the review process.
Between 1986 and 1990, Monsanto paid nearly half a million dollars to conduct four review studies at UVM, the first on Jersey cows and the next three on Holsteins. As public interest in the hormone grew, the study's then-director, Dr. Alice Pell, told a Vermont journalist: "Cows treated with BST [or BGH] are not getting sick any more than other cows do."
But in 1990 a UVM employee provided data on the Holstein test herd to Rural Vermont and the agriculture committees of the Vermont Legislature. The information showed that five deformed calves had been born at UVM in less than a year, compared to none in the previous five years. The deformities were of two types rarely seen on dairy farms.
Rep. Christiansen analyzed the data for Rural Vermont, and his 1991 report found that BGH-treated cows "had twice as many uterine infections, required more inseminations per conception, had greater difficulty in calving, and required more drugs when sick than the non-BGH group. They also had twice as many stomach surgeries, hoof rot, and foot and leg injuries."
Rural Vermont's report had a widespread impact. Data released by the FDA to U.S. Rep. Bernard Sanders (Independent-VT) in response to the Congressman's inquiries about Rural Vermont's report showed that the earlier Jersey study at UVM had seen a mastitis outbreak among nine of 20 treated cows -- compared to two of 20 in the control group. The calving rate was also lower among the treated Jerseys, who had more injection-site reactions than the controls. Soon after, UVM and Monsanto admitted the mastitis outbreak did occur; yet a 1988 preliminary report by UVM had suggested no such problem.
As Rural Vermont's information about BGH testing surfaced, federal regulators went on the defensive, denying to the U.S. General Accounting Office (GAO) that it had crucial I.D. numbers for UVM test cows -- even though the FDA had already leaked those numbers to Monsanto.
After Vermont State Sen. Francis Howrigan and Rep. Bob Starr wrote to the director of FDA's Center for Veterinary Medicine, describing Rural Vermont's findings on animal health, the FDA responded with a letter to Sen. Howrigan that was critical of Rural Vermont's analysis. But the FDA's letter was sent not to Howrigan, but to Monsanto -- which used it to lobby the press all across the country.
Howrigan's letter to FDA had included the critical I.D. numbers of some of the UVM Holstein test cows that were injected with BGH -- information that was vital to analyzing the test results, and which UVM had refused to release. The FDA's "Howrigan" letter then provided those confidential I.D. numbers to Monsanto, without the FDA having first taken steps to verify the information. Since Monsanto now knew which cows Rural Vermont had successfully identified as BGH-treated cows, they could simply alter data to reassign those cows to the "control" group (cows not injected with BGH). And because only Monsanto and UVM (not the FDA) had full access to cow I.D. numbers, the truth could now never be fully known.
Sen. Howrigan never received his letter from the FDA. The FDA said its leak of the letter to Monsanto had been an accident. But in so doing, the Agency had violated its own regulations against releasing proprietary information -- and it totally violated the confidential treatment that the legislators had requested for the Rural Vermont data.
The FDA's approval process was beginning to appear fatally flawed.
The Congressional GAO, at Congressman Sanders' request, had already opened an inquiry into the UVM/Monsanto BGH test herd; but it could not get the data it needed to make a full analysis of the situation from the FDA or UVM or Monsanto. The Vermont Legislature and the GAO worked for a year and a half to acquire the UVM test data, but every attempt was blocked by Monsanto and the University of Vermont. (The code identifying the BGH-injected cows in the test herds remains secret.)
In a separate report issued in 1992, the GAO said that the FDA had not looked closely enough at the indirect human food-safety risks that BGH might pose. "The increased milk production in cows from the BGH treatment has triggered an increase in their incidence of mastitis, which would often be treated with antibiotics," GAO said: "As a consequence, higher levels of antibiotic residues in milk and beef could result."
The FDA responded to the GAO report by convening a panel of advisors, primarily veterinary academics with little expertise in human health issues, who essentially whitewashed the report. In March 1993 the FDA's Veterinary Medicine Advisory Committee said the higher incidence of mastitis in BGH cows fell within "acceptable limits."
Meanwhile at UVM, researchers, under questioning, were obliged to concede that the test herd Jerseys had, in fact, shown a 450 percent higher rate of mastitis and 85 percent more injection site reactions than the untreated control cows. They also acknowledged that deformities had occurred and reproductive performance had been poorer in the treated cows. Soon after, a dairy journal reported that the BGH-treated cows infected with mastitis needed much more antibiotic treatment than control animals with mastitis.
In November 1993 the FDA released a Freedom of Information Act report summarizing its research on BGH. A pooled analysis of many studies found "there was an association between sometribove (BGH) usage and the number of cows affected with clinical mastitis." The treated cows' likelihood of contracting the infection was "about 1.79 times that of a control animal."
The FDA approved Monsanto's BGH product in November 1993, although a Congressional moratorium delayed commercial sales until February 1994. Soon after, the GAO found that two FDA employees who had worked on the agency's technical review of BGH, at least one of whom was a former employee of Monsanto, had violated ethics and conflict-of-interest rules 11 times. In fact, Christiansen writes, "for years, Monsanto and the universities have manipulated the flow of information, rushing to print positive results but delaying for years any negative findings."
When BGH finally hit the market, a list of potential side effects was included as a package insert label. This label, required by the FDA, confirms six herd-health problems predicted by Rural Vermont's 1991 report: retained placentas and uterine infections, hoof rot, foot/leg injury, ketosis (metabolic disturbances), "indigestion," and "increased frequency of use of medication."
Before Rural Vermont's 1991 report was issued, academic reports (mostly financed by Monsanto and other BGH manufacturers) were almost totally silent about animal health problems linked to BGH. While many questions have still not been adequately answered, Rural Vermont's report triggered media attention, focussed the attention of Congressional investigators, and brought important data to light.
It is an open question whether any of the critical data reluctantly released by the FDA and UVM would ever have been revealed if Rural Vermont had not obtained animal health data and issued its report. Rural Vermont's report was cited in farm press accounts as contributing to the European Union's decision to extend the moratorium on BGH in Europe. But with commercial approval of BGH in the U.S., a new chapter of the BGH/animal health story began.
... Christiansen's report finds that the BGH review process was marred by serious flaws, conflicts of interest, violations of ethics rules, and illegal leaking of proprietary information by FDA throughout the review process.
At UVM, researchers were obliged to concede that the test Jerseys had, in fact, shown a 450 percent higher rate of mastitis and 85 percent more injection site reaction than the untreated control cows.
A few months after Monsanto brought its BGH product Posilac to market, the farm media was full of positive stories in which the company and its researchers said farms using the product were making more money and producing more milk. Yet at the office of the Wisconsin Farmers Union, farm advocates began hearing some not-so-rosy stories that involved the farmers themselves.
"After discounting a number of reports of dead cows as `rumors,' I opted to follow one of these reports up by calling the farmer personally," writes Mark Kastel, Director of Governmental Affairs with Wisconsin Farmers Union, in Rural Vermont's new report Down on the Farm: The Real BGH Story.
Kastel called the Wisconsin farm couple who told him that one of the best cows on their farm had died of a ruptured blood vessel in her udder after she'd been injected with BGH. The farmer said they had quit using the drug on most of their animals. Kastel decided "there must be a basis for all these `rumors' we were receiving." He also was aware that no organization -- other than Monsanto (which was required to do so by law) -- was gathering data about the animal health effects of BGH.
Soon after, in Summer 1994, Wisconsin Farmers Union and the National Farmers Union set up a BGH hotline for farmers. What they learned is the basis of Kastel's startling new report on the experiences that farmers across the country are actually having with bovine growth hormone.
The first several farmers to contact the hotline did not want their names used in public, though several had experienced severe animal health problems. Then a lifelong western New York farmer named John Shumway, who said he was "not an anti-BGH activist," called the hotline and soon after gave an interview to an Albany newspaper.
Because of severe BGH reactions, Shumway told the paper, "I've probably had to sell 50 cows on it, and I've got a 200-cow herd, so I've lost a quarter of my dairy herd ... Every time I went to give a shot, I had 20 new cases of mastitis. It's been devastating!"
After just two months of injections, Shumway had quit using the drug. His herd's production was now as much as 20 pounds a day less than it had been before he began using BGH. Bruce Krug, coordinator of the New York Farmers Union, wondered if the drug was not having an addictive effect on the cows, reducing their future health and productivity.
The BGH hotline was now getting reports from other farmers around the country. In Texas, which was having a heat wave, "farmers were having problems with both health and keeping their production up," Kastel writes. "We received first - and second-hand reports of farmers discontinuing the use of BGH on a wholesale basis.... Reports came in from Texas indicating that the average weight of cull cows (cows sold for beef) had fallen over the past year by 150-200 pounds in many cases."
Monsanto and a number of veterinarians acted quickly to discount these reports. They said that cows just didn't die from ruptured udder vessels -- and that, in general, farmers who were having these herd-health problems were poor managers. Farmer Shumway's vet, (identified by several local farmers as an aggressive promoter of BGH) told a Wisconsin reporter that Shumway had always had mastitis problems and a high culling rate. Kastel responded by putting the reporter on the phone with Shumway himself -- who said that for several years his farm had won Kraft's milk-quality honors for extremely low somatic cell counts. (High somatic cell counts generally indicate the presence of mastitis, low counts the absence.) At first, much of the media seemed unwilling to believe that there really were serious adverse reactions to BGH in some dairy herds.
Widespread coverage of Shumway's problems and the Farmers Union hotline drew a steady increase in calls from farmers who were willing to talk with the press themselves. More farmers said they'd lost cows to ruptured arteries, had lost calves to spontaneous abortions, and had battled mastitis, stress, and lumps and sores at injection sites. One farmer said he had lost two cows, which had been in perfect health, within hours of BGH injection. Monsanto paid for an autopsy, but the university vets who performed the autopsy said they could not pinpoint the cause of death.
CBS Evening News stepped in, preparing a well-researched report on Shumway's troubles with BGH that aired in September 1994. Meanwhile, a Freedom of Information Act request by the Farmers Union obtained copies of the six-month report on BGH that Monsanto had been required to submit to FDA. The report described cow deaths, abortions, mastitis outbreaks and other major health problems.
Federal regulations required Monsanto to forward to FDA within 15 days any reports it received of serious health problems -- yet the company had held onto most of those serious reports until September 1, 1994 when it had to make its required six-month report. This failure to report data was, Kastel writes, a "flagrant disregard of the law" -- yet no action was taken by the FDA.
When he saw CBS's interview with John Shumway, Florida dairyman Chuck Knight had the feeling of "a weight being lifted off my chest." He also had experienced mastitis problems while using BGH, and had been forced to cull scores of cows. Knight had asked Monsanto for help; the company suggested he improve his sanitation, and said no other farmers were having trouble with mastitis. After Knight's milk was rejected by his dairy for very high somatic cell counts, he also quit using BGH. But by then BGH had exacted a very high emotional and financial toll.
Kastel called the FDA, which said Monsanto had not forwarded a report on Knight's problems with BGH to it. Staff scientists at FDA's Center for Veterinary Medicine had been working cooperatively with the Farmers Union, but "were now instructed `not to speak to us,'" Kastel writes. Despite the Farmers Union's efforts, "the FDA has been wholly unwilling to cooperate with us in trying to ascertain whether or not Monsanto is fulfilling its legal responsibility by reporting all adverse reactions." (While the FDA says that it subsequently did require Monsanto to submit data on a timely basis, as the law requires, FDA has never publicly reprimanded Monsanto nor have any penalties been imposed.)
Another Florida farmer, Al Cole, told the hotline his cows had developed severe hoof problems with BGH, and half his herd's production had actually gone down. "The cows that were now getting sick were the same ones that had experienced the increases in production," Kastel writes. "After the third shot, some of Mr. Cole's cows began to die." He lost eight cows and had to cull 15 more.
Monsanto officials -- who had checked Cole's herd and pronounced it healthy before the injections began -- now blamed Cole's troubles on his feed -- which had not changed at all.
By mid-February 1995, adverse-reaction reports submitted by Monsanto showed that 806 farmers had reported troubles with BGH, "up 740 percent from the first half of the year," Kastel writes. The Farmers Union hotline "was getting reports from around the country of farmers discontinuing BGH usage on a wholesale basis." A Texas dairy nutritionist reported that 65 percent of the farmers he worked with that had been using BGH were phasing it out.
Said New York farmer Jay Livingston, who had lost half a dozen cows while having herd-wide health problems on the drug: "When we started to develop problems, Monsanto came out to the farm and told us we were the only ones having problems. They blamed us and had every excuse ... but totally rejected that BST had any relationship to our problems."
As reports of farmer discontent with BGH mount, Monsanto has cut its product's price and intensified its marketing efforts. The company has reportedly offered a $100 bounty in some areas to farmers who help recruit their neighbors to use BGH; the company has also issued $150 vouchers for veterinary care when farmers begin using the drug. Monsanto has also funded joint promotional campaigns with veterinary clinics in an effort to sell farmers on BGH.
In an interview with the St. Louis Post-Dispatch, Dr. Stephen Sundloff, director of FDA's Center of Veterinary Medicine, said that based on the reports of problems with BGH on the farm, "FDA does not find any cause for concern."
"The question is," Kastel concludes, "who are you going to believe? A multinational drug company with a vested interest in selling its product and protecting its image in the marketplace? The FDA, which had disregarded the GAO and other authoritative bodies by approving this drug with less than its customary scrutiny? Or dairy farmers first-hand reports?"
As we go to press in Fall 1995, many of the country's larger-scale dairy operations are among those now giving up the drug. In some areas of the country, farmers are reporting that 60 to 90 percent or more of the farms that have tried BGH have discontinued its use. There is an excellent chance that this drug will die in the marketplace. Now the question is how many family farms will suffer needless losses in the meantime.
I've lost a quarter of my dairy herd ... Every time I went to give a shot, I had 20 new cases of
mastitis. It's been devastating!"
Dairy farmer John Shumway, the first to speak out about BGH
By October 1995, adverse-reaction reports by Monsanto showed that 1300 farmers had reported troubles with BGH in tens of thousands of their cows.
"When we started to develop problems, Monsanto came out to the farm and told us we were the
only ones having problems. They blamed us and had every excuse ... but totally rejected that BST
had any relationship to our problems."
Dairy farmer Jay Livingston
Copies of this Summary Report:
single copy: free
two to 99 copies: $0.25/copy
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Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval
Down on the Farm: The Real BGH Story (full length reports):
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This Summary may also be found on the Internet's WWW at: http://plainfield.bypass.com./~N_E_Research/bgh.html