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Down on the Farm:
The Real BGH Story Animal Health Problems, Financial Troubles

MARK KASTEL / Rural Vermont 1995
A Project of the Rural Education Action Project


By mid-summer 1994, about five months after Monsanto's brand of bovine growth hormone (BGH) hit the market, the Wisconsin Farmers Union started to receive anecdotal reports of problems associated with the hormone's use. At the same time, the press was carrying glowing reports from both Monsanto and researchers, describing widespread success and profitability on farms using the product. Nowhere in the farm media coverage was there any mention of farmers having problems, or of any risks that might be associated with the use of this new technology.

The farm organizations that had tracked the preapproval scrutiny of BGH knew very well that at least some side effects should have been expected after introduction. Reports in the agricultural media had documented widespread and virulent outbreaks of mastitis, among other problems occurring at university test herds. In addition, at least one dairy farmer who tested synthetic BGH for another pharmaceutical company went public with catastrophic health problems his cows had experienced, and the eventual loss of his entire dairy operation. The FDA required Monsanto to include a comprehensive warning label in every shipment of its product. This label delineates 21 health problems associated with the use of Posilac®, Monsanto's synthetic BGH product. In addition to mastitis, the warning label outlined problems associated with the reproduction of animals: cystic ovaries, disorders of the uterus, decrease in gestation length and birth weight of calves, increased twinning rates, and retained placentas.

Other side effects included increased body temperature (a problem in warm weather), digestive disorders, problems with cows being "off feed," enlarged hocks and lesions of the region of the knee, and disorders of the foot. The Posilac® label also suggests that some farmers could expect injection site reactions such as swelling, permanent blemishes, and open and draining injection sites.

Although the agricultural media was not reporting any problems occurring on dairy farms, despite years of research and a history of problems with dairy cows during the testing period, it would be reasonable to assume - based on the warning label, statistical evidence from the FDA, and anecdotal accounts that had surfaced - that problems were being experienced.

The Farmers Union Hotline

Even while monitoring the positive reports in the press, the Farmers Union in Wisconsin began receiving a number of anecdotal reports suggesting problems were indeed being experienced in the field, 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

The original report was relayed to me by one of our members here in Wisconsin. I was told of a neighbor who had allegedly lost 40 cows due to a reaction to BGH. After obtaining the name and phone number of the dairy farmers. I was able to get through to the farm wife. Although I found that 40 dead cows was a gross exaggeration, they had experienced a problem with a number of their cows and one had, in fact, died. This was a family farm at which 22 of the 55 cows had been injected with BGH. After their third injection, one healthy young cow described as one of the best cows on the farm - spontaneously died. The farmer was told by the veterinarian that the animal had ruptured a blood vessel in her udder.

This particular farmer told me they had discontinued the use of the product on most of their animals, and was "only injecting cows that would likely be shipped [sold for beef] anyway."

This conversation convinced me that there must be some basis for all the "rumors" that we were hearing. The problems that were occurring with BGH on farms did warrant further investigation. It should be emphasized at this point that no other organization in the country (other than Monsanto!) was collecting this data, or making any attempt to disseminate it so farmers could make a truly educated decision as to whether or not they should adopt this new technology on their farms. In late summer 1994, Wisconsin Farmers Union and the National Farmers Union based in Denver, Colorado set up a toll-free hotline (1-800-272-5531). [mindfully.org note: we called this number but got no response] Its purpose was to collect and disseminate information on the experiences of farmers whose cows had suffered serious side effects after being injecting with BGH. We publicized the hotline by issuing press releases and placing notices in the farm media.

The John Shumway Farm, Lowville, New York

BGH: Why does it matter?

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.

BGH is bad for family farms. 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.

BGH is bad for cows. 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.

Consumers don't want 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 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 IGF1 (insulin-like growth factor-1), the molecule that transmits the effects of BGH in cows. IGF1 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 as Precedent.
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: 

  • herbicide-tolerant plants—genetically engineered seeds designed to withstand higher dosages of specific herbicides;

  • porcine somatotropin, a growth hormone for hogs—which will require rearing pigs in indoor confinement facilities—speeding growth of giant corporate farms at the expense of family-scale pork producers, and increasing the likelihood of animal health problems;

  • genetically engineered fruits and vegetables with genes from widely diverse species (including flounder genes for frost resistance), with unknown environmental effects; and

  • patented genetically engineered animals, including cows with increased BGH bred in—putting at risk centuries worth of genetic diversity.

As of early August 1994 responses to our hotline had come only from farmers who had experienced problems but were unwilling to have their names used in public. Several of the farmers who called had lost cows to what they felt were problems related to BGH usage and were, experiencing other associated health problems. generally virulent outbreaks of mastitis.

In early August 1994, I became aware of a farmer in western New York by the name of John Shumway. Although Mr. Shumway, like virtually all the farmers BGH hotline, made it clear that he was not an "anti-GMO activist," he was willing to speak out. through an interview carried in the Albany, New York weekly Metroland (8/11/94), Mr. Shumway described how he was forced to borrow tens of thousands of dollars from his bank in order to replace 50 cows that he had called [removed from the herd] due to severe BGH reactions.  "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 heard," Mr. Shumway said.  he went on to say, "every  since and went on  BST, I've had severe mastitis problems.  Every time I went together shot, I had 20 new cases of mastitis.  It's been devastating!"

Mr. Shumway, a lifelong farmer, had been injecting his herd for approximately one and a half to two months. He said his production went up from 72 pounds of milk per cow per day before using BGH to 83 pounds of milk a day while being treated with BGHonly to drop to 60 and even as little as 50 pounds after quitting BGH; for a loss of 10 to more than 20 pounds a day.

Mr. Shumway's interview was important because he was the first farmer willing to go on record and speak to the press concerning his experiences.

Bruce Krug, coordinator of the New York Farmers Union, said at the time, "When looking at the production drop after discontinuing BGH use, one has to wonder if the drug is having an addictive effect on the cows." Some farmers now believe that when removed from treatment, the cow's own hormone seems to be suppressed. Milk production at the Shumway farm and on some other farms dropped by over 15% when BGH usage was discontinued, as compared to pre-treatment production.

Mr. Krug went on to ask, "Is it like cows on crack or heroin, they become addicted to the drug, health impaired, and their future ability to give milk is compromised?"

We recontacted Mr. Shumway in early September 1995. He told me that as of August 1, 1995 (about a year after he discontinued BGH) he had replaced 135 .out of his original herd of about 200 cows. Mr. Shumway said that he had tried using leftover BGH on 15 cows that were late in their lactation cycles; most of them contracted mastitis, and two cows aborted. Mr. Shumway's losses ultimately came to about $100,000 as a result of lost milk production and the need to replace cows that would no longer produce well and/or that were having terminal health problems.

Mr. Shumway said that almost everyone in his area had quit using BGH. "Last year, 30 area farmers were using it; now it's down to three or four," he said. "On most of the remaining farms, the cows look thin and production is down, even with BGH usage. Virtually every farmer who tried BGH got mastitis."

At the time we learned of Mr. Shumway's problems with BGH, we began getting increased reports on the hotline from farmers around the country. A number of reports came in from Texas, which was experiencing a heat wave. Farmers were having problems with both herd health and keeping their production up. We received first- and secondhand reports of farmers discontinuing the use of BGH on a wholesale basis.

Also at this time, reports began coming in indicating that the weight of BGH cull cows [cows sent to slaughter] had fallen over the past year by 150-200 pounds in many cases. In regions where higher-than-average use of BGH was taking place the value of slaughter animals was dropping at a rate offsetting the potential profit farmers might glean from the extra BGH-induced milk production.

Monsanto Responds

As soon as the first reports of problems on farms began surfacing, Monsanto and the dairy establishment in general tried to discount farmers' claims. After our first news release announced the hotline and outlined the first farmer's experience with a ruptured blood vessel in the udder, Monsanto and a number of veterinarians were outspoken in seeking to discredit the individual farmers and the work of the hotline.

The first response came from David Dickson, professor of Dairy Science at the University of Wisconsin, who said he had talked to dozens of farmers in Wisconsin who were using the product without problem. He went on to say that it was unlikely that a cow would die from a ruptured blood vessel in the udder. "I've never heard of anything like that," he said. By now, we had received a number of hotline reports of cows dying of internal hemorrhaging, including blood vessels ruptured in the udder. Documents the FDA has made public also recount a number of reports from farmers with similar complaints

A week after the Associated Press first made public John Shumway's story, I received a phone call from Mike Flaherty, a reporter at the Wisconsin State Journal, a daily paper based in Madison, Wisconsin. The reporter told me he had just spoken to John Shumway's veterinarian and there was no credibility in the story we were circulating that Mr. Shumway's problems were caused by BGH When asked how he obtained the name and phone number of the veterinarian, the reporter said he had received an unsolicited phone call from Monsanto, and they had supplied the name and number. When I suggested that it is well documented that many veterinarians around the country are working directly with Monsanto to promote their product, and that this veterinarian could very well be one of them, I was told by the reporter, Mike Flaherty, that he felt the veterinarian had credibility.

Both the vet and Monsanto had told Mr Flaherty that the farmer in question had always had problems with mastitis, had always had a very high culling rate with his cows, and that his current problems with mastitis were caused by "hot feed."

After speaking with Mr. Flaherty, I called Bruce Krug of New York Farmers Union. I was told by Mr. Krug that he happened to be vice president of the farmers cooperative where farmer Shumway had delivered his milk, and that even though the co-op had stricter standards than the New York state standards pertaining to somatic cell count (indicative of mastitis), Mr. Shumway "had always produced good quality milk." Mr. Krug and other farmers also told me that the veterinarian in question appeared to be aggressively promoting BGH and had hosted a dinner sponsored by Monsanto where the company promoted BGH.

I then put Bruce Krug on a conference call with the reporter Flaherty and myself to convey this information. Although I thought this would at least plant seeds of doubt in the reporter's mind as to the veterinarian's objectivity, he expressed no interest in changing the way he would interpret the data and write his story. I then hung up with these two gentlemen and directly called Mr. Shumway in western New York. I had not to this point spoken directly to Shumway; I only was aware of his problems through interviews with him that I had read in the press.

Mr. Shumway was willing to talk directly to the reporter, so I arranged another three-way conversation between Mr. Shumway, Mike Flaherty and myself. Flaherty told Mr. Shumway that he had been told by Shumway's veterinarian that Shumway had always had a problem with mastitis.

Shumway responded: "I've never had a problem with mastitis before. We're very proud of our milk quality. In fact, for the last three consecutive years, we won the Super Milker Award, Kraft's highest award for milk quality in our region. We won this for extremely low somatic cell levels."

Flaherty then brought up the claim of Shumway's veterinarian that Shumway had always culled a lot of cows. Shumway responded: "That's true. I push my cows hard and I turn them over quickly. Last year, I think we culled about 50 cows. During the two and a half months we were on BGH, we culled about 50 cows!"

Flaherty went on to say that the veterinarian maintained that Shumway's problems with mastitis were because he was feeding "hot feed." Shumway responded: "How would he know what kind of feed I'm feeding! He's never seen my feed, and we've never discussed my rations!" (The reporter erroneously thought that "hot feed" pertained to a mold problem, although the term usually refers to feed very high in protein content. This is not usually associated with inducing mastitis.)

The testimony of both the farmer and an official of a farmers' cooperative in New York State should have at least planted a question in the reporter's mind about the credibility of the testimony from the veterinarian, Dr. Samuel Yancey. Instead, Flaherty went ahead and published a report (Wisconsin State Journal, August 14, 1994) critical of farmer Shumway's management practices and highly critical of other members of the press who had initially run the story on Mr. Shumway without, in Mr Flaherty's opinion, digging deeper into the story and substantiating the problem (i.e., talking to the farmer's veterinarian).

Unfortunately, the preceding story is not atypical. In almost all responses to reports of farmers having problems, dairy "experts" told the press, in essence: "they are a bunch of dumb farmers out there who don't have good management control on their farms. This is a problem with farm operation, not with this new miracle drug." And for too long, much of the press bought this "blame the victim" line of reasoning.

Other Farmers Step Forward

Following the widespread dissemination in the agricultural press regarding Mr. Shumway's problems and our hotline, we started to get a steady increase in responses. More importantly, some of these farmers were now willing to have their names used and to speak to reporters. Melvin Van Heel, who milks 70 cows outside of Little Falls, Minnesota told the hotline, "I've had one abortion, then just one thing after another. My vet said to quit [the BGH use]. The majority of my cows had some health problemsmastitis, lumps/open sores at injection sites, stress, etc." Mr. Van Heel said that about halt of his first- lactation heifers and almost all of his "older cows" had been negatively affected in some way.

We contacted Mr. Van Heel again in early September 1995. He said that he had tried BGH again on ten relatively low producing (40-50 pounds/day) late lactation cows in June 1995. Almost all contracted mastitis right away, and all ten eventually got mastitis. All the cows had high somatic cell counts.

"I got more milk, but I didn't think it was worth it," Mr. Van Heel said. He said that he does push his cows hard, and normally maintains a rolling herd average of about 21,000 pounds ''They can only handle so much."

Steve Schulte of Harbor Beach, Michigan, who milks 165 cows, had one cow die after being injected with BGH. "This cow died from internal bleeding, a ruptured artery," Schulte stated. "Out of 80 cows injected, half showed production increases and half actually went down. We were culling so many cows, I had to buy three cows lust to get two milking. I figure my replacement cost per cow was $2,250." When I spoke with Mr. Schulte again in September 1995, he told me that he had cut his veterinarian's bill dramatically since quitting BGH.

Another Michigan farmer who called the hotline but asked not to be identified said he lost two animals after they were injected with synthetic BGH hours earlier. "The two cows, one three-year-old and one five-year-old, were in perfect health prior to their injection," he said. "After we lost the second cow, Monsanto paid for an autopsy at Michigan State University. Unfortunately, according to the veterinarians there, they could not pinpoint the cause of death."

When I talked with this farmer a year later, I was told that about 10 percent of his cows had died on the farm (not culled) while he was using BGH in 1994. After quitting BGH the percentage dropped to 3 percent in 1995 He said not many farmers in his area were using BGH now. As opposed to last year, "You don't see any of those FedEx® trucks going down the road anymore." (Monsanto sells Posilac® directly to farmers via a toll-free phone number; all deliveries are made by Federal Express.)

The Farmers Union questioned whether dairy farmers could make a profit using BGH if these reports turned out to be representative- In a press release, we said: "Every farmer should make a risk/benefit analysis before using any new technology. Although most of our reports showed a marked increase in milk production, there may be a great 'downside risk' to using this product " With other farmers stepping forward and more reports being carried in the media, we felt we were beginning to accomplish our mission, in both gaining credibility for our research and getting this information directly to dairy farmers.

The CBS Evening News Looks at BGH on the Farm

By fall 1994 the national media was beginning to pay some attention to reports of animal health problems linked to BGH use. Family farm groups were now frequently contacted by news reporters, radio stations, and local TV reporters. The Farmers Union was contacted by CBS Evening News and asked to collaborate on a piece (to be hosted by their medical reporter, Dr. Bob Arnot) that would profile farmers' problems with BGH.

In addition to speaking at length with CBS News producers about the reports we had received over the hotline, we were happy to give them the names of other farmers to contact. CBS subsequently interviewed John Shumway at his farm, along with FDA personnel, officials at Monsanto, and Dr. David Kronfeld, one of the few veterinarians who had been willing to openly question the safety of BGH.

CBS aired its "Eye to Eye" segment on problems with BGH down on the farm on September 27, 1994, and it turned out to be a very powerful piece that in turn led to more press attention and more farmers calling the BGH hotline.

Chuck Knight, Florida Dairy Farmer

After chores, Chuck Knight was sitting watching the CBS Evening News. He had just finished milking his 90 cows. He watched with interest as John Shumway was being interviewed in New York, telling of his problems with a massive mastitis outbreak on his farm. Mr. Knight also watched my interview with CBS, stating that by that point farmers from seven different states had called the hotline relaying their stories of woe concerning BGH.

Mr. Knight said watching these interviews was like a "reprieve," - like "a weight being lifted off my chest." He had initially experienced mastitis problems back in June 1994 and had asked Monsanto for help. Two company representatives visited Mr. Knight in June and recommended that he work with his county extension agent to develop higher standards of managing his herd in regard to the sanitation of his cows. Although Mr. Knight had been dairying for decades without mastitis problems, these Monsanto experts had apparently decided that here was another "dumb farmer" who needed an education. Most importantly, Mr. Knight said that the Monsanto representatives told him "no one else was having a problem with mastitis like I was."

So Mr. Knight followed the instructions of the Monsanto agents and the University of Florida, and changed the washing technique he was using on his cows' teats. But mastitis persisted, and his somatic cell count which had risen to 1,000,000 when he was using BGH lowered somewhat for a time, only to again shoot up to 1,500,000 (the legal maximum for somatic cell count was 750,000). After receiving a warning that his milk could not be accepted by his dairy due to high somatic cell counts, he discontinued use of BGH. Only after he stopped using BGH did mastitis subside and cell counts return to the normal range.

The psychological effects for Mr. Knight and his family were devastating. He said that he was having problems sleeping at night. The catastrophic financial losses the farm was experiencing - due to loss of milk that had to be dumped because of substandard quality and the use of antibiotics, and being forced to cull scores of cows - was placing a great burden on his family's emotional well being.

The day after Mr. Knight watched the CBS report, he called the FDA and asked if Monsanto had forwarded his complaints to their office. Although he was told that the names of all farmers relayed to the FDA were confidential, the FDA told him that they had received only two other reports from Florida, and neither were from his towns Mr Knight was outraged and asked the FDA for the hotline's phone number. He contacted us the next day.

In addition to the mastitis problems, after Mr. Knight stopped using BGH some of his sick cows immediately developed a severe problem with their hooves, indicative that they were not metabolizing their feed correctly - a problem that appears to have been triggered by the cows going off BGH (this hoof problem is also indicated on Monsanto's product insert label). Mr. Knight was forced to slaughter a number of these cows also.

I, too, followed up with the FDA on Mr. Knight's report, and was told the same thing: "Mr. Knight's report was never forwarded by Monsanto to the FDA." How many other farmers had complained to Monsanto and been told that "no one else is having problems?" How many adverse reaction reports were not forwarded to the FDA as required?

When I recontacted Mr. Knight in September 1995, he said, "Hardly anyone is using it now, down here.... I don't know of anyone using it."

Monsanto & the FDA: Stonewalling

When it gave Monsanto approval to market BGH commercially, the FDA announced that it had also reached an agreement with Monsanto, under the terms of which, Monsanto would compile reports of animal health problems and forward them to the FDA. (The FDA apparently did not worry that this might be seen as a "fox and henhouse" relationship.) Monsanto's first report, summarizing animal health problem reports submitted to the FDA for the first six months of commercial use (early February - early August, 1994) was released (without the identification of the individual farmers) in September 1994, after Farmers Union filed a Freedom of Information Act (FOIA) request.

In Monsanto's report, they stated that 96 reports of adverse reactions were forwarded to the FDA (each report covered one farm; in most cases, many cows experienced problems). When we reviewed these reports we immediately noticed that, like the reports forwarded to our hotline, they included numerous cases of spontaneous deaths of cows, widespread outbreaks of mastitis, spontaneous abortions, and other catastrophic health problems.

In analyzing these incident reports, we noted that 68 of the 96 reports were forwarded to the FDA on September 1; only 28 had been received before that date. When we asked the FDA what this pattern indicated, we were told that after all new drug introductions, the manufacturer was required to forward all reports of adverse reactions on a semi-annual basis during the first year. They added, however, that any "serious problem" or any adverse reaction not delineated on the product insert label should be forwarded immediately to the FDA, or no later than 15 days after the manufacturer becomes aware of the problem.

In reviewing the reports dated September 1, 1994 with FDA officials, I inquired, "Doesn't death of cows constitute a serious health problem? Don't multiple deaths of cows, multiple abortions, etc., constitute serious problems?" I was told that indeed these were serious problems, and that Monsanto did not conform with the federal regulations - that they should have forwarded these reports to the FDA at an earlier date. To our knowledge, no formal or public action has been taken against Monsanto to follow up on this apparent disregard of the law. Monsanto was now saying, in public relations materials, that approximately 8 percent of U.S. farmers were using the product on about 800,000 cows. Farmers Union seriously questioned the accuracy of these numbers. To our surprise, the FDA actually backed us in asserting that Monsanto's usage level numbers were greatly inflated. In an October 3, 1994 press release, the FDA said that in fact, only about 560,000 cows were being injected with BGH. Thus, according to the FDA's figures, Monsanto had inflated the number of cows injected with BGH by more than 40 percent.

Unfortunately, the FDA's cooperation did not last. Although staff scientists in the FDA's Center for Veterinary Medicine had been working with us on a very forthright basis, sometime in mid-fall of 1994 they were instructed "not to speak to us." When queried, they then told us that they "were not to speak to anyone" and we were to be referred to either the Center's director of the Office of Surveillance and Compliance, Dr. Bert Mitchell, or the FDA's public relations officer. Although Dr. Mitchell has been very courteous and willing to supply us with copies of the documents submitted by Monsanto, he has taken no interest in any enforcement aspect pertaining to the apparent discrepancies in Monsanto's required reporting (reports submitted late and reports withheld).

By mid-September 1994, Monsanto had referred a total of 123 reports to the FDA. By mid-December, the number of reports had jumped to 276. Why the large increase? Was Monsanto being embarrassed by media reports that pointed out it was not forwarding all incidents to the FDA? By October - after Canadian Broadcasting Corporation (CBC) aired a TV news special that disclosed the failure of Monsanto to make timely reports of adverse animal health effects - the FDA said that Monsanto was now submitting adverse reaction reports on an immediate basis. Does this account for all the increase?

It seems very likely that increased media exposure of animal health problems was prompting more farmers to come forward with their own stories. We were also probably seeing an increase in reports based on cows having been given the drug for a longer period of time. And hotline reports of breeding/ reproduction problems were increasing as some cows ended a full lactation (reproduction and milking) cycle and began to show problems with getting bred back.

After Mr. Knight and a number of other farmers reported to us that they believed their adverse cow health reports were not forwarded to the FDA, we asked the FDA's Dr. Mitchell if he would help us compare lists to ascertain what other farmers' reports they might not have. To date, the FDA has been wholly unwilling to cooperate with us in trying to ascertain whether or not Monsanto is fulfilling its legal responsibility to report all adverse reactions.

In addition to dismissing our inquiries, the FDA has disregarded inquiries from at least one congressional office, claiming that the agency's responsibility to keep these names confidential restricts it from making this comparison. But we have suggested a number of ways in which we would be willing to submit our list to an independent third party (congressional office, a major accounting firm, other administration officials, etc.), so that the confidentiality of all farmers could be maintained while still determining whether the FDA had knowledge of ail farmers on our list.

We do not understand why the FDA does not appear to be taking as seriously as we do the questions we have raised about Monsanto's methodology and earnestness in forwarding reports to our governmental watchdog agency.

Al Cole: The Story Behind the Story Continues

Al Cole, who milks about 150 cows :n Florida, read an interview that Chuck Knight gave to the Tampa Tribune in late September 1994. "I 'm angry and disgusted," said Mr. Cole. "I started injecting my animals in March or April. After the third shot the cows had sore feet and were all humped up. Although Monsanto staff told him before starting on the BGH treatments that his cows were in good shape and the product would do nothing but good, his cows were now suffering from a severe case of laminitis (hoof problems).

PHOTO [not included] Al Cole (right) of Dade City, Florida had three severely deformed calves born to cows injected with BGH. Mr. Cole (shown here with herdsman Charles Westphal) had cows die and experience severe hoof problems after they were injected with BGH.

Mr. Cole told us that about half of his cows increased production by about six pounds, but half actually went down. The cows that were now getting sick were the same ones that had experienced the increases in production. The ones whose production went down or stayed steady seemed to be doing better. After the third shot, some of Mr. Cole's cows began to die; he worked with his veterinarian to change rations to save the rest of his herd, but he was told that many of these sick cows would not make it. Mr. Cole lost eight cows and was forced to cull an additional 15. "I used it because everyone was using it," Mr. Cole said. "I've never seen anything like this problem before." Although Monsanto officials checked over Cole's farm and said his cows were in great shape before he started to inject cows, once Mr. Cole began having problems they blamed them on the feed. His veterinarian suggested that maybe it was the floor of his barn that was causing some of the hoof problems. Mr. Cole emphasized that none of these conditions had changed since he had started on the BGH regime.

I spoke with Mr. Cole again in September 1995, almost a year after our initial conversation. He reported that he had borrowed $20,000 in the spring of 1995 to replace cows. Cole said: "If it wasn't for the loan, some off-farm income, and the fact that we had 50 bred heifers ready to go on line this year, I doubt that we would have been able to stay on the farm." Of 64 cows injected in 1994, 32 had responded with more milk. Almost all of the cows that had responded were now gone from the herd because of animal health problems.

Most interesting to me, Mr. Cole said that three cows that had been injected with BGH later gave birth to severely deformed calves.

Mr. Cole said: "Last fall, three 'bastard' calves [deformedlegs over headguts outside] were born on my farm. This would typically be seen in 1 in 10,000 births. In six weeks, I had three bastard calvesa farmer should experience one in a lifetime!" (A similar outbreak of severely deformed calves was found by Rural Vermont in their investigation of the University of Vermont's BGH test herd see Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval by Andrew Christiansen; order form in back of this report.)

Like others I had recently contacted, Mr. Cole reported that BGH use is down sharply. One of the fieldmen he does business with told him that last year 11 of 12 herds he worked with were using BGH; this year it is down to 1 in 12.

Mr. Cole reported that he too had called the FDA after he had contacted the Farmers Union hotline in late September of 1994. The FDA did not have his report. He called the FDA back three weeks later and was told that they [the FDA] now did have the report. "They said the paperwork got lost," Mr. Cole reported.

Mr. Cole also elaborated on the difficulties he had experienced getting Monsanto to help him analyze his cows' problems with BGH in 1994. "Experiencing problems after the third shot, I called the salesman," Cole said. "Although he said he would 'be right there,' he never came. After cows began to die, I went over the salesman's head. Then the Monsanto salesman, Monsanto vet, and the University of Florida vet came out. They looked at my animals and said they would be back. I never heard from them again."

One Year of BGH... Looking Back

A pharmaceutical company introducing a new drug must report all adverse reactions to the FDA on a semi-annual basis during the two years and on an annual basis thereafter. After being pestered for over 45 days, the FDA finally released raw data (adverse reaction reports) submitted by Monsanto in mid-March 1995. This was in response to two separate Freedom of Information Act (FOIA) requests submitted by Farmers Union and a consumer group, the Foundation on Economic Trends.

By mid-February 1995, Monsanto claimed to have increased sales to 3,000 new farms, up 30 percent. But the number of farmers who experienced animal health problems through mid-February had grown to 806 - up 740 percent from the first six months of BGH usage. What was going on? Why the large increase? The new FDA data indicated health problems with well over 10,000 cows. By all appearances, animal health problems were increasing at a much faster rate than the use of BGH.

The Farmers Union hotline was now getting reports from around the country of growing numbers of farmers discontinuing BGH usage. Many of these reports were from farmers whose cows were just entering their second lactation after initially being treated with BGH in 1994.

Jay Livingston, who milks approximately 200 cows in Lisbon, New York, is one of many farmers who have related their "horror stories" to the Farmers Union. "For the first couple of months on BST, our cows seemed to be doing okay," he said. "Their milk production increased from 50 to 65 pounds per day ... then they just went all to pieces! We had a half-dozen die and then the rest started experiencing major health problems. Cows went off their feed, and experienced severe weight loss, mastitis and serious foot problems."

"Initially we went to a meeting co-sponsored by Monsanto and our veterinarian," Mr. Livingston continued. "They came and checked out our herd and said everything was rosy, that this BGH is the greatest thing since sliced bread. We did just what they told us to do 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 from here to hell and back, but totally rejected that BST had any relationship to our problems."

Mr. Livingston, who farms with his brother, said his family had never had serious herd health problems before taking the vet's recommendation and going on BGH.

After losing over $100,000 in milk sales and having to replace 50 cows that either died or had to be culled, Mr. Livingston is understandably bitter. "We always had quality milk with a somatic cell count of 100,000-150,000. When we were on BGH, it went up to 700,000 or more. They should outlaw this stuff !"

Even though the Livingston farm hasn't used BGH since June 1994, many of the cows that were injected then later had problems while giving birth During a two-month period of time, the Livingstons had 20 twin births. This was a devastating situation for the farmer: virtually none of the calves survived, and the mortality rates of the mothers were approximately 50 percent.

I spoke again with Mr. Livingston in September 1995. It has not been an easy year for him 'After quitting the BGH treatments, my cows started to freshen in fall 1994 through January 1995,'he said. "During that period of time, I had 90 percent twin births (35 sets of twins!). The calves were underweight--not worth anything. The cows did not clean out, some experienced displaced stomachs. I lost about 10 cows; most did real poor."

"We lost $100,000 in milk sales due to sharply lower production and having to dump inferior quality milk. My cows were drying up and were down to 45 pounds of production during the summer and didn't recover until January 1995. Out of my 180 cows, 70 were dry all winter," Mr Livingston said.

"Monsanto told us that 'the only reason we were having trouble was we had more cows than the barn would hold.' They told us the problem was that some of the cows were outside and had nothing to eat. We never had a problem before. We milk three times a day and they get quality [totally mixed rations or TMR) feed at each milking. They also have access to dry hay during the day when they are out of the barn,' he added.

"Before going on BGH, I went to a meeting sponsored by Monsanto and my vet. They told us to have all our ducks in a row, be all set. It'll do wonderful things for our cows. The fact that we were on TMR and 3X milking was the ticket for our success. But it really did an awful number on our cows!... Our nutritionist told us that our cows were 'just burned out' after the BGH. I don't know when we will be over this... I felt bad for the animals. Some of our animals were having problems with their feet going off to the side; Monsanto told us that 'no way could it do anything to the feet,'" Livingston said. He concluded: "I've seen everybody quit, I don't know of any herd on it now."

Farmers Quit

Reports continue to come in of farmers all over the country who have quit using BGH for both herd health and economic reasons. In a published report in Dairy Profit Weekly (March 6, 1995), dairy nutritionist Mike Conner of Black Earth County, Texas reported that 60 to 70 percent of his farmers that had been using BGH were now phasing out its usage.

Quoted in Dairy Profit Weekly Mr. Conner said, "Many concluded that the risk was not worth the benefit." Some producers who had stopped using BGH in the summer of 1994 because of hot weather problems decided to begin treating their herds again in September. Many of these discontinued its use a month later.

One of these producers was Conner's best manager with 1,000 cows. "The production increase was there," Conner said; but some of the same problems that had been experienced during the heat of the summer surfaced again in the fall.

Dick Bengen, an 800-cow dairy producer from Everson, Washington told a Toronto dairy symposium that his cows fell far short of predictions while using BGH. He got only six extra pounds of milk daily, and needed nine pounds to break even. Bengen said: "We spent a lot of hours questioning our management abilities and kept asking if we're the only ones in the U.S. that can't make money with this stuff," according to the Canadian journal Farm and Country (February 28, 1995).

Many of Mr. Bengen's cows that had increased milk production were being overfed. Bengen didn't think he should have to mismanage cows to get a production increase. "Virtually every producer who had tried BST had quit by this time, or they were only going to carry their cows through that they started on BST," he said. "if they used it again, it was going to be on a very limited basis.... It was none of this 60% of the herd stuff any more."

Although Monsanto has always contended that the synthetic hormone technology was "size neutral," most family farm organizations in the U.S. have questioned this claim. Larger factory type farms (300-5,000+ cows) send their cows to slaughter much sooner than do average family farmers (the average Wisconsin dairy farm milks 50 cows). In most of the larger operations, cows last only 1-2 lactations (milking cycles) before they are culled; on family farms it's not unusual to find cows 6-12 years or older. We learned through clinical studies and adverse reaction reports to the FDA that young cows with physical stamina were a deciding factor as to whether or not a farmer could successfully use this product.

Larger farms are also more likely to utilize technology such as totally mixed rations (TMR) feeding equipment, which offers better control of their animals' nutritional intake, another factor in successful BGH usage. If anyone could produce more milk, control their increased costs and use this product profitably, it would be the larger farms. It is thus very significant that within a year after BGH was approved we began hearing numerous reports of large farmers dropping the product.

I spoke to a veterinarian here in Wisconsin who requested anonymity. He told me his veterinary practice had approximately 50 large herds (large by Wisconsin standards - over 200 cows!. In 1994, four herds, or 8 percent of his clients, were using BGH. By early 1995, three of the four had discontinued usage. Rather than specific health problems, the farmers cited increased culling rates and general 'lack of profitability" as factors for quitting

Reports from Mexico, where BGH has been on sale much longer than in the U.S., indicate that farmers have been consistently experiencing the same reactions in their herds as in the North. There has been a drastic reduction in  BGH  use in  Mexico since farmers found they had to spend more on feeding programs than the milk  was worth, according to Fernando Bernal, DVM.

Monsanto's Sales Tactics: Getting Desperate?

Published reports in both the New York Times (March 12, 1995) and Dairy Profit Weekly March 6, 1995) indicate that sales resistance to rBGH has mounted. Monsanto has cut the price their product by almost 15%. The New York Times  analysis of the situation questioned whether Monsanto's  highly aggressive, sophisticated and expensive sales promotion campaign could possibly recoup the company's investment as problems on farms mount. In some parts of the country, in addition to the  price cut, Monsanto began offering a $100 bounty to farmers who provide the names of their neighbors as possible BGH sales prospects if the neighbor tries BGH. BGH is so controversial in the dairy community that some farmers who are injecting their cows are not even telling their spouses, according to published reports

Monsanto has also engaged in a practice of issuing $150 vouchers for veterinary care to farmers who initially ordered BGH. Bruce Krug, coordinator of the New York Farmers Union, has said: "$150 may seem rather innocuous until you realize that some of these veterinarians have worked hard at pushing this product, and that can quickly add up to thousands of dollars.

Mr. Krug, a Constableville dairy farmer, researched the fact that New York, among many other states, has statutes that prohibit veterinarians from taking any "direct or indirect" compensation from pharmaceutical companies to promote their products. "Monsanto has underwritten joint promotional campaigns with veterinary clinics in an effort to sell farmers on BGH," according to Mr. Krug. New York Farmers Union is trying to verify whether these promotional efforts and financial considerations constitute a violation of law.

Interestingly, not only are vets being compensated through Monsanto's voucher program, but in some instances, they are also profiting handsomely from their customers' misfortune when things go wrong.

"After our problems started in April and May, we experienced over a $3,000 vet bill," said Jay Livingston of Lisbon, NY. "After discontinuing BGH usage, our vet bill went to virtually zero. We didn't even see the vet for six weeks."

Past experience at the FDA shows that adverse reaction reports significantly under-represent the true level of problems being experienced in the field. For example, estimates of adverse reactions to human health problems related to drug reactions are sometimes 20 times higher than the number that is actually reported to the FDA.

Although reports of herd health problems have now been well-documented by both the FDA and Farmers Union hotline, the number of farmers actively using the product cannot be verified. An early 1995 survey of dairy farmers by the University of Wisconsin indicated that only 5.5 percent of dairy herds in Wisconsin were using BGH. The survey also showed that approximately 90 percent of Wisconsin dairy producers had no intention of using BGH in the future (Country Today, March 1, 1995).

Who Should We Believe?

The FDA continues to downplay its own data on the links between BGH and animal health. In response to our analysis of the FDA's first year report, Dr. Stephen Sundlof, director of the FDA's Center for Veterinary Medicine, granted an interview with the St. Louis Post-Dispatch (March 15, 1995). Dr. Sundlof said that, "based on these reports, FDA does not find any cause for concern."

Sundlof criticized our use of "raw data," saying that many farmers' reports had no relationship to BGH. Indeed, FDA officials and Monsanto joined forces to claim that only 500 reports are "possibly" related to BGH. If this were true, it would mean that there has been "only" a 400-plus percentage increase in adverse reactions, not a 740 percent increase ("no problem?"). But the FDA and Monsanto have not been able to explain how they decided which animal health reports were or were not linked to BGH.

We continue to question the completeness of Monsanto's reports to the FDA and the FDA's analysis of these reports. For example, the FDA's analysis shows only 57 cows either died or were slaughtered due to complications with BGH through February 1995. Our reports for the same period reflect considerably more. In fact, if you add up the cows that have been slaughtered or died as a direct result of BGH injections just on the farms profiled in this report, the total from this handful of farmers approaches 200 and is still climbing.

The problems outlined in this report are not new and they are not unique. As Vermont State Rep. Andrew Christiansen points out in his companion report, Recombinant Growth Hormone: Alarming Tests, Unfounded Approval, serious animal health problems occurred in University test herds before BGH was approved for commercial use. Posilac®'s product insert label warns of 21 separate animal health problems that can occur with BGH. The FDA's own data shows that cows injected with BGH are 79 percent more likely to contract mastitis.

Since BGH has been on the market, reports of animal health problems in all parts of the country have mounted steadily. The FDA's downplaying of these reports appears to be a classic bureaucratic response to a problem: denial.

As to the allegations that we used raw data, we used exactly what the FDA gave us data which it had obtained from Monsanto. As with all pre-approval testing, the FDA relies on the pharmaceutical companies who make a product to present their "unbiased and impartial research." All the reports received by the FDA come directly from Monsanto. Many of these reports question the farmers' observations, disagreeing that BGH was a factor in the cows' health problems.

The real question is, who are you going to believe? A large 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 product 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. The question is how many family farms will suffer needless losses in the meantime.

"All reports indicate that the number of farmers from California to New York state using BGH is decreasing," according to New York dairy farmer Bruce Krug. "The only way to manage the risks associated with BGH is to stop using BGH."

About the Author

Mark A. Kastel is director of governmental affairs for the Wisconsin Farmers Union. He also works as a political policy and management consultant. Mr. Kastel has over 20 years experience in agri-marketing, including stints with J.I. Case, FMC, and as CEO of the Heartland Farm Equipment Company. He lives with his wife, Kathy Doerfer, on their 160-acre farm nestled in the rugged hills just north of LaFarge in Southwest Wisconsin.

Rural Vermont is pleased to be issuing two closely related special reports on the effects of bovine growth hormone (also known as recombinant BGH or rBGH) on animal health. Both reports are intended to be helpful for farmers, the media, and anyone concerned about BGH and animal health.

Reports of serious animal health problems in BGH-treated herds have come in steadily in the year and a half since BGH has been commercially available. Several newspapers and television networks have run well-documented stories on animal health problems linked to use of BGH. But many farmers who have had poor or disastrous results with BGH have been reluctant to talk about their problems, many perhaps fearing to be called a "bad manager."

Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval revisits Rural Vermont's 1991 report on animal health in the Monsanto/University of Vermont (UVM) test herd, and traces what has been learned as a result of the initial report. Our 1991 report exposed many animal health problems, including an alarming number of dead and severely deformed calves. Subsequent controversy exposed additional problems, both in the UVM test herd and in the FDA's review process. Our new report presents the whole story clearly and in some detail. Andrew Christiansen, author of the 1991 report and a Vermont state Representative (D-East Montpelier) is author of the new report.

Down on the Farm: the Real BGH Story summarizes animal health problems which have surfaced around the nation since BGH was approved for commercial use. This report describes the actual experiences of a number of farmers many of whom have won dairy herd quality awards - who have experienced serious animal health problems while using BGH. Mark Kastel, Government Relations Director of Wisconsin Farmers Union and coordinator of Farmers Union's BGH animal health hotline, is principal author of this report.

With these reports, Rural Vermont is directly challenging Monsanto's marketing strategy which centers on creating a perception that BGH works well for "good managers." By implication, if a farmer has a problem with BGH, he or she must not be a good manager. Rural Vermont believes that the evidence shows that in fact, good managers often have bad results with BGH This message needs to be clearly presented to farmers and the dairy industry, many of whom have heard only Monsanto's very biased side of the story.

To order copies of the report, send $3 per report or $5 for a copy of each to BGH Report, Rural Vermont, 15 Barre Street, Montpelier, VT 05602. (Inquiries about bulk orders are welcome.) Tel: 802-223-7222


Yves Brasseur, dairy farmer, Newport Center 		Cindy & Daryl LeBlanc, dairy farmers, Westfield
Mary Jane Choate, dairy farmer, Barnet 			Ron Morrissette, dairy farmer, East Randolph (Co-Chair)
Doug Clark, farmer, Franklin (Treasurer) 		Jenny Nelson, dairy farmer, Ryegate (Co-Chair)
Bob Gray, vegetable/dairy farmer, Newbury 		Anthony Pollina, Middlesex
Sherry Kawecki, dairy farmer, Alburg (Secretary) 	Dexter Randall, dairy farmer, Troy
Walt Kawecki, dairy farmer, Alburg 			Jacques & Jean Rainville, dairy farmers, Highgate Center
Ann & Jack Lazor, dairy farmers, Westfield 		Debby Yonker, dairy farmer, Danville

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At the heart of Vermont's future, Rural Vermont is a statewide grassroots organization dedicated to building a prosperous rural life. Rural Vermont supports a rural economic policy for Vermont that recognizes the importance of agriculture and natural resource based industries, support for small rural businesses, along with good jobs, fair wages, and decent health care, housing and transportation for all rural citizens. We are committed to broad based sustainable agriculture in harmony with the needs of the family, community, and the environment for future generations.

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