Alarming Tests, Unfounded Approval
The Story Behind the
Rush To Bring rBGH to Market
ANDREW CHRISTIANSEN / Rural Vermont Jul95
For Rural Vermont,
A project of the Rural Education Action Project (REAP)
ABOUT THIS REPORT
CONTENTSAbout this Report Overview Preface by Dr. David S. Kronfeld, DVM Introduction rBGH Research at UVM Mixed Messages Deformed Calves and the Rural Vermont Report The Rural Vermont Report and Its Impact FDA's Response to Rural Vermont Report FDA Sabotages an Independent Investigation General Accounting Office Investigates UVM Attempts Damage Control FDA Dismisses All Warnings On Milk Safety FDA Approves Monsanto's POSILAC® Monsanto's Huge Investment in POSILAC® New Safety Questions Emerge Conclusions and Recommendations
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.) See back page for order form.
rBGH Research at University of Vermont (UVM) Raised Concerns
In 1991, a report by Rural Vermont revealed deformed calves and serious health problems with the rBGH test herd at the University of Vermont.
Congressmen asked the General Accounting Office (GAO) to conduct investigations of rBGH, FDA and the approval process for rBGH.
FDA's Approval Process Was Flawed
The FDA illegally leaked proprietary information. FDA also released Rural Vermont data, making it impossible to conduct an independent investigation of what happened at UVM.
The FDA told the GAO that it did not have cow I.D. numbers, even after it had leaked them to the press.
The FDA selectively challenged nine of the cows Rural Vermont thought were rBGH-injected cows, saying they were untreated "controls." However, eight of the nine cows had lactation curves which suggest that they were rBGH-injected cows.
- The FDA employed Monsanto researchers to review Monsanto research.
UVM Hid a Mastitis Outbreak
- UVM told the press that there were no health problems with rBGH, but later conceded that in its Jersey study, there was a 450% increase in mastitis rate and 725% more cases of mastitis among the rBGH-treated cows.
The FDA Approved rBGH
Despite Animal Health Risks
The FDA dismissed studies by the GAO which found drug residues, including antibiotics used to treat mastitis in milk from rBGH-treated cows.
The FDA ignored its own findings of a 79% greater risk of mastitis with the use of rBGH. By inventing the concept of a "manageable risk," the FDA ignored its own criteria that new animal drugs be safe.
The FDA approved Monsanto's POSILAC® but required an unprecedented listing of 21 adverse health effects on the label.
Conclusions and Recommendations
Congress and the President should rescind FDA's approval of rBGH until its safety can be assessed.
- Conflict-of-interest regulations for FDA reviewers should be strengthened.
If rBGH approval is continued, FDA should require that all products be labeled and sales registered.
rBGH, Technology, Farms and Families
Broad hopes and expectations have been raised around the coming of biotechnology to farming' and the advent of its first major product -,recombinant bovine growth hormone, or rBGH.
Biotechnology will, its developers promise, heighten on-farm efficiency as nothing has since the tractor. The advent of rBGH, a bacteria-made analog of the growth hormone in cows, has been compared to pasteurization and artificial breeding in its new- found importance to the dairy industry. Those promises, however, have come almost entirely from the drug companies that developed rBGH and from the professors who accepted company funds for drug testing and consultant fees under contracts that constrained communications.
Farmers and consumers have other, mutual interests. High among them are a stable dairy industry and the continuing availability of inexpensive, wholesome milk and dairy products for the American diet. With these more vital interests in mind, Rural Vermont, a grass-roots, nonprofit organization, closely followed the experimental studies that were conducted in Vermont as part of the U.S. Food and Drug Administration's process of testing and approving rBGH.
The first rBGH drug to be approved is POSILAC®, made by the Monsanto Company. Its active ingredient, sometribove, is synthesized not by a cow but by coliform bacteria. Because rBGH is different in composition from natural bovine growth hormone, testing can distinguish milk from POSILAC®-treated cows; yet the FDA has, so far, declined to require this test.
POSILAC® stimulates extra milk production - about five to 15 more pounds of milk per cow, per day. It also has 21 side effects, most of them admitted by Monsanto only after the drug's approval in November 1993. Two years earlier, in 1991, Rural Vermont discovered that several of these adverse effects - including a far higher incidence of mastitis - had appeared in cows on whom rBGH was being tested at the University of Vermont (UVM). The university did not make timely reports of these side effects - but Rural Vermont did, in a controversial report and then in testimony before committees of the Vermont Legislature.
The essay that follows tells the story of the questions that were raised about rBGH before it was approved, and of the responses to those questions by Vermonters, by Monsanto and by the FDA. The story told here depicts an approval process that was good in parts but bad in others. The FDA deserves credit for its protracted evaluation of cow safety, for the eventual disclosure of 21 side effects, for the post-approval additional testing of POSILAC® on 24 farms for 5 years, and for the carefully reasoned initial decision on human safety.
Remaining in contention, however, are the FDA's failure to reconsider human safety as new information became available on milk IGF-1 and the unnatural methionyl-144-epsilon-N-acetyllysine-rBGH, the failure to curb public release of misinformation from manufacturers and indentured professors, and the failure to prevent Monsanto's claim that the drug's undesired effects are manageable, which is readily disproven by the data available on milk production and mastitis.
This report clarifies at least some of the facts behind the persisting question: Is rBGH safe for cows, farming and consumers, now that it has entered the milk stream of America?
David S. Kronfeld, DVM, PhD
David S. Kronfeld
DVM, PhD, DSc, DACVN, DACVIM, MRCVS
The Paul Mellon Distinguished Professor of Agri
culture and Professor of Veterinary Medicine
Virginia Polytechnic Institute and State University
Blacksburg, VA 24061-0306
In the late 1970s, recombinant DNA technology made it possible to manufacture large quantities of recombinant bovine growth hormone (rBGH) through genetic engineering. To make rBGH, the plasmid of a bacterium is cut by enzymes, and then combined with a cow's DNA. It is reintroduced to the bacterium, placed in a fermentation tank and allowed to multiply, then separated and purified before delivery to the farmer.1
In 1979, Monsanto paid Genentech $990,000 for the rights to rBGH, along with an agreement to pay royalties and make "milestone" payments. Genentech delivered the first 600 milligrams of rBGH in December 1981. By 1990, Monsanto had spent $300 million on rBGH, including the 1988 construction of a $50 million manufacturing plant in Austria. Analysts estimated that Monsanto was spending $50 million per year on rBGH .2
In the early 1980's, Monsanto, and three other companies - American Cyanamid, Upjohn and Elanco (a division of Eli Lilly) - announced their intention to develop their own rBGH products, and contracted with universities to do research.
Companies that sell animal drugs need the approval of the U.S. Food and Drug Administration (FDA). To get FDA approval, the company, known as the sponsor, must prove that the product is safe and effective when used as directed.
The approval process begins with an Investigational New Animal Drug application (INAD), which allows the interstate shipment of unapproved drugs to universities or farms that will be conducting the research.
Once these studies are complete, they may be submitted to the FDA as part of a New Animal Drug Application (NADA). The NADA is then assigned to a primary review division within the Center for Veterinary Medicine (CVM). Studies which support a NADA are called "pivotal." Drugs under review are evaluated by FDA for human health safety, the effectiveness of the drug' animal safety, and the drug's ability to be reliably and safely manufactured.
Technical reviewers evaluate the sponsor's submissions for accuracy, and provide recommendations and comments that are reviewed by the branch chief and division director before being sent back to to the primary reviewer.
The primary reviewer will check the technical reviewer's statements for accuracy. These findings become part of a transmittal letter reviewed by the primary reviewer's branch chief and division director before being sent to the sponsor for further action.
The GAO summarized the review process for Monsanto: "Monsanto filed an INAD for recombinant bovine growth hormone in May 1981. It submitted its NADA for sometribove in 1987. The human health safety study was completed on August 28, 1989. The effectiveness and target animal assessments were completed on March 30,1993. The environmental and manufacturing reviews were completed on May 7, 1993. Sometribove was approved by FDA on November 5, 1993. In a related and separate action, FDA published interim milk labeling guidance on February 10, 1994."3
- Wade Roush, "Who Decides About Biotech? The Clash Over Bovine Growth Hormone," Technology Review 94, no.5 (July 1991) p.31
- Keith Schneider, New York Times Magazine, 10 June 1990.
- United States General Accounting Office, Letter to U.S. Representative George E. Brown, Jr, U.S. Representative David Obey, and U.S. Representative Bernard Sanders, (Washington, D.C.: 19 October 1994).
While this GAO report minimized the extent to which the approval process was compromised, it found serious flaws, conflicts-of-interest, and violations of ethics rules by the FDA throughout the review process for rBGH. The FDA had named Suzanne Sechen, who had prepared rBGH studies for Monsanto under the supervision of a Monsanto consultant, as the Primary Review Officer for rBGH. "Her actions raise questions about the objectivity that she would be able to bring to her review of these articles," the GAO observed.
Correspondence with Vermont legislators revealed that the FDA had also illegally released proprietary information from the UVM test data. Proprietary information is information considered to be part of trade secrets and cannot be divulged by federal regulators. Most of the cracks in the approval process were revealed as a result of the Rural Vermont report issued in 1991, which first discovered serious health problems with cows injected with rBGH at the University of Vermont.
rBGH Research at UVM
Monsanto underwrote four rBGH studies at the University of Vermont (UVM) from 1986 to 1990 for which it paid UVM nearly half a million dollars ($459,261). UVM received nearly $140,000 in grant money from Monsanto to do the first study, which evaluated the effect of the expected dose of rBGH on 46 Jersey cows.4 Begun in the fall of 1986, this was a non-pivotal study. The FDA defines a non-pivotal study as one that can include different management conditions and basic research on the mechanisms of the drug5 but doesn't require multiple doses of the drug.' In this case, the study's purpose was to see if rBGH would stimulate production increases in Jersey cows similar to those that had been observed in Holsteins.6
In this first study, completed in 1988, half of the cows were injected with 500 mg of rBGH every eight days, and the other half were injected with an inert substance. Two of the "controls" and two treated cows were excluded from the analysis, leaving 21 cows in each group.7 Cows treated with rBGH had higher feed intake and body weight and produced 30% more milk than the control animals. Cows were monitored, but not treated with rBGH, during a second lactation. Three studies followed using Holstein cows. The second study, begun in 1987 using a different rBGH product, was an uncontrolled and uninspected trial, which was part of a graduate student's research.
The third and fourth studies were pivotal studies, for which UVM received over $319,000 in Monsanto grants. Pivotal studies are defined by the FDA as "well-controlled studies designed to evaluate the efficacy and/or animal safety of a new animal drug under expected use conditions of the drug." They usually include multiple doses. These studies began in 1988 and 1989, respectively, and were pivotal for two different second generation rBGH products, for which Monsanto had not yet submitted an application for approval.8 The Holstein studies were completed in 1990.
- "Listing of Current Awards and Months of Future Support" (Division of Agriculture, Natural Resources and Extension College of Agriculture and Life Sciences).
- Kay Holcombe, "Report on Data Submitted in Support Of The Safety and Effectiveness Of BST," (December 12, 1991). Report from the U.S. Food and Drug Administration to U.S. Rep. Ted Weiss (D-NY).
- Alice N. Pell and A. John Bramley, "bST Research at UVM," (Burlington, VT: University of Vermont, March 1992). Press release.
- Holcombe, "Report on Data," 1991. Second-generation rBGH products would be new products developed by Monsanto, which are different than the POSILAC® now being sold.
As farmer and public interest in rBGH surfaced in the late 1980's and the Vermont Legislature considered proposals to regulate the sale of rBGH milk, UVM came under closer scrutiny. In 1989, considerable press attention focused on where the milk from UVM's rBGH test herd was going.9 The Vermont House Agriculture Committee visited UVM's farm and heard a presentation from Dr. Alice Pell, who was then directing the rBGH research. She said that only a "small sample" of the rBGH-treated Jerseys had developed mastitis. She noted that except for some swelling around the injection sites, there were no overall differences with the control animals.10
University statements to the press described the rBGH-treated cows as suffering no ill effects from the injections. In 1989, Dr. Pell asserted that the shots were not producing adverse reactions in any of the animals. She said that "cows treated with BST are not getting sick any more than other cows do."11 In 1990, Dr. Pell said that she found no increases in mastitis among her research animals.12
- Deb Brighton, "BST Milk: Where Does it end up?" The Addison Independent, 22 May 1989, p.1
- Andrew Christiansen, Clerk of the House Agriculture Committee, Minutes of House Agriculture Committee, 13 April 1989.
- Kevin Kelly, "BST: A Health Hazard For Cows," Vanguard Press, 6-13 July 1989.
- Bryan Pfeiffer, "Tests Show Problems With BST," Rutland Daily Herald, 25 January 1990.
- Jean Annexstad, "If BST IS Approved, How the Hormone would affect your herd's production, reproduction, health." Dairy Herd Management (October 1989) p.60.
Despite the repeated assurances of UVM, Monsanto and FDA that rBGH was safe for humans when cows should be inseminated, and conception rates describe how many inseminations are necessary to achieve a successful pregnancy. If any of these factors are higher than normal, an additional cost is borne by the farmer. Retained placenta is the failure of the afterbirth to be eliminated from the reproductive tract following calving: if not treated, it can lead to uterine infection. Metritis is an inflammation of the uterus.) Just three months later, a different story came out of Cornell. On January 4, 1990, the same Dr. Jim Ferguson, along with Dr. David Barbano, told farmers that the dose of rBGH required to get the desired production increases also resulted in lower conception rates. Ferguson recommended keeping cows through only two lactations for greatest profitability. "Bring her in, push her, and cull her before she starts having problems and costing money," he said. The article continued: "He said that treated cows will have more cystic ovaries and retained placentas than untreated cows; will milk longer, have more days open and have an increased calving interval."14
In 1988, news reports covered the generic drug scandal, in which FDA officials were found to have accepted money and gifts from the companies whose drugs they were reviewing.15 A 1990 General Accounting Office report revealed that more than half the new drugs approved by FDA over the previous ten years had since been found to be unsafe, and had to be pulled from the market or relabeled to note unanticipated side effects. The GAO study also found that the more quickly new drugs were rushed to market, the more likely they would produce adverse effects.16 FDA spokesman Jeff Nesbit admitted that an important part of determining a new product's safety was monitoring adverse reactions after approval, since it takes so long for a company to move a product through the FDA approval process.17
Consumers began to realize that the FDA was more concerned with corporate profits, than with human health. It was at this juncture that a startling event occurred in Vermont that would involve government officials from the state to the federal levels, sharpening the debate about rBGH and ultimately influencing policy in Europe.
Deformed Calves and the Rural Vermont Report
In the fall of 1990, a University of Vermont employee named Marla Lyng provided Rural Vermont, a farm advocacy group, and the chairs of the Vermont House and Senate agriculture committees with information and photographs showing that rBGH-treated Holstein cows at UVM were giving birth to deformed calves and experiencing severe health problems. She gave Rural Vermont copies of the computer-based health records for the herd and a list of those cows injected with rBGH, so that comparisons could be made with cows not injected with rBGH.
In 1991, Rural Vermont hired the author of the report, Andrew Christiansen, a state representative who had researched rBGH issues for several years as a member of the House Agriculture Committee, to analyze the UVM test herd data and issue a report on his findings. The chairs of the Vermont House and Senate agriculture committees also hired a consultant-veterinarian to analyze the data. However, the consultant did not have cow identifier numbers to determine which cows were treated with rBGH.
The most surprising discovery was the number of deformed calves born to cows that were part of the rBGH trial. Severe deformities are rare: A farmer is not likely to see more than one or two in a lifetime, if any. In less than a year, between August 1989 and August 1990, there were five severely deformed calves born at UVM. According to a document provided to the Legislature by UVM, there had been no deformed calves born in the five years before this period."18
- Linda Goodwin, "BST Main Topic At Dairymen's Day," New England Country Folks, 15 January 1990 p.2.
- Dumas, "Fallout From Drug Scandal May Be a Stronger FDA," Congressional Quarterly, 3 March 1990, pp. 664-667.
- States General Accounting Office, FDA Drug Review: Postapproval Risks 1976-1985, (Washington, D.C.: April 1990).
- Associated Press, "Half of New Drugs Had Unanticipated Side Effects," The Times Argus, 29 May 1990.
- "Incidence and Identity of Dead (including abnormal) and Turin Calf Bearing Cows at Spear Street and Wheelock Farms 1985-91," Enclosed with letter sent from Dr. A. John Bramley, (BSc, PhD, FIBiol, PAS) Chair of the UVM College of Agriculture's Dept. of Animal and Food Sciences, to Senator Howrigan and Representative Starr.
Of the five cows that gave birth to deformed calves, at least three had some relationship to the rBGH experiments. Two cows were in the group injected with rBGH, and at least one was a daughter of a rBGH-injected cow.19
The remaining two cows' histories are subject to controversy. They were identified as daughters of rBGH-treated cows in the original Rural Vermont report, but FDA discounted them in the now-famous "Howrigan letter."20 At least one of those cows, declared an untreated control by FDA, is still questionable, as there is a missing lactation curve in the individual cow records during the year she would have been a part of the experiment. Further, the cow did not milk long enough to qualify as a control animal.
Researchers reported two types of deformities in the rBGH-treated cows. One had an achondrogenic fetus, which is a type of "bulldog" calf. It is a genetic condition also known as Bovine Dwarfism, which means that cartilage and bone do not develop properly. Aborted at six and one half months, the calf had a short, thick, bulging forehead, extremely short legs, a depressed nose and an undershot jaw.21
The other rBGH-treated cow was unable to calve and had to be killed during labor. An abnormal fetus was removed, which was undefined by the university in its records22 but described by Ms. Lyang as a "dipygus", or calf with nine legs. A dipygus fetus has "two rumps" or a double pelvis with extra legs.
A third deformity was an encephalocoele fetus, born to an untreated cow that was a daughter of a rBGH-treated cow. This type of deformity involves the birth of a calf with a large fluid-filled hole in its head.23
Two facts make the incidence of these deformed calves particularly disturbing. First, these are deformities rarely seen on the farm. While difficult births and a misshapen hoof or leg might occur now and then, severe deformities of this type are extremely rare. Second, the university did not keep accurate records on these deformities' occurrence, and there was no mention of them in the individual cow health records. This, along with other problems with the health records, was noted in a report from a veterinarian whom the Vermont Legislature hired to review the UVM cow health records.
The veterinarian's report detailed "many apparent discrepancies in individual cow records in the Cow Search database," and wrote: "One should question if it is possible that the Cow Search records might have been tampered with by an over-zealous researcher? Inaccuracies in the records could be the result of deliberate actions, normal human error or inattention to detail. "24
- The deformed calves born to the two rBGH-treated cows were confirmed in Dr. Alice Pell's seminar held at UVM on March 9, 1992. The deformed calf born to the daughter was not disputed by the FDA.
- Guest to Howrigan, 7 February 1992. Original letter from FDA's Dr. Gerald B. Guest, Director of Center for Veterinary Medicine, was never received. Notation in the upper right hand corner: "This is a duplicate of the original letter dated January 17, 1992, and mailed on January 21, 1992."
- "A Review of Records Of a Sample of Dairy Cows From the University of Vermont Dairy Herd," Presented to: Honorable D. Francis Howrigan, Chair, Senate Agriculture Committee and Honorable Robert A. Starr, Jr. Chair, House Agriculture Committee, (February 18, 1991). The author wished to remain anonymous.
- Dr. David Kronfeld, to Representative Andrew Christiansen, 16 November 1991
- "A Review of Records," 1991.
Along with deformed calves, Rural Vermont's analysis and report found a higher incidence of health problems among the rBGH-treated than the untreated cows. These results were sent to Dr. David Kronfeld for review and statistical analysis 25
The Rural Vermont report found that rBGH-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, along with cases of hoof rot and foot and leg injuries; and they experienced three to four times as many incidences of retained placenta and ketosis. Ketosis is an increase in the blood and urine of certain ketones and keto-acids, which are normal byproducts of the breakdown of fat. Ketosis is a sign that the cow is using her body tissue to make extra milk; in this state she is sometimes called being "off-feed."
The report also found that daughters of cows treated with rBGH had similar health problems, including more hoof rot and twice as many stomach surgeries and uterine infections than non-rBGH cows. They also required 36% more inseminations per conception than non-rBGH cows, and had greater difficulty calving.
Dr. Kronfeld found statistical significance between rBGH-treated and non-BGH cows in three areas: (1) for incidence of two illnesses - retained placenta and ketosis; (2) the number of dead and deformed calves; and (3) the number of "beefed" cows, and of all cows removed from the herd.
The Rural Vermont Report and Its Impact
Rural Vermont released its report at a joint press conference with legislators at the Vermont State House on November 18, 1991. Statements made by Senator Francis Howarigan, Rep. Robert Starr, Rep. Christiansen and Dr. David Kronfeld, recognized the need for an independent study using the actual list of rBGH-treated cows and the schedule of their injections. The speakers noted that the sample sizes were small, especially for the "rBGH daughters," and that conclusions about cause and effect could only be drawn with some caution.
The goals of the press conference were to point to the significant health problems associated with the use of rBGH, draw attention to the role of university-corporate research collaboration in hiding information from the public, and to request that federal agencies complete the investigation that Rural Vermont and the Legislature had begun.
The presenters were hoping that FDA would compare the Rural Vermont data with what they had received from Monsanto, and then compare that with data from other sites around the country. Immediately after the press conference, Rural Vermont sent copies of the computer files and all other information to FDA and the Vermont congressional delegation.
There was an immediate reaction to the report's findings. Local newspapers highlighted the story and interviewed UVM officials. Dr. John Bramley, chair of the university's animal sciences department, conceded, "Certainly with this trial there were some abnormal calves born," but he added that it was "not possible to identify if there is any causal relation ship. "26
There were news reports in the dairy states of Wisconsin and California, culminating with a segment broadcast on Cable News Network (CNN) the following February.27 U.S. Senator Patrick Leahy urged Monsanto to release the data from its rBGH studies at UVM, and to provide GAO with access to company data .28
- Kronfeld to Christiansen, 16 November 1991. Dr. David Kronfeld applied Fisher's Exact Test, which compares the frequency of illnesses in the two groups and calculates the probability that the difference of frequencies is due to random error. The test also may be used to calculate an odds ratio (OR). If OR = 2, then the relative risk of this disease is increased by a factor of 2. Dr. Kronfeld found 10 adverse health effects that had a less than 5% probability of being due to chance or had an odds ratio more than 2. These were retained placenta, uterine infection, ketosis, abomasal surgery, hoof rot and foot/leg injury; cows removed from the herd, and calves born dead and calves deformed.
- David Gram, "Cow Hormone Called Unsafe," Burlington Free Press, 19 November 1991.
- Amy Rinard, "Thompson Urged to OK Ban, Significant Animal Health Problems Reportedly Found," Milwaukee Sentinel, 19 November 1991; Donna Walters, "Milk Battle, Cow Drug Fight Is Taken to Consumers," Los Angeles limes, 22 November 1991; Sally Lehrman, "Bovine Growth Drug Draws Fire," San Francisco Examiner, 27 November 1991; "CNN To Report on BGH Controversy," Times-Argus, 9 February 1992.
- Leahy Wants Release Of BST Study Data, Times-Argus, 29 November 1991.
Monsanto faulted Rural Vermont for not making distinctions between the various trials that were conducted at UVM. However, that was confidential information that Rural Vermont and the Vermont legislators did not have access to. As UVM spokesperson Nicola Marro put it, "They [the Legislature] have been given data on every single cow in the herd. The problem is we won't identify which are the (BGH) cows."29
In the British agricultural press, the Rural Vermont report was cited as an important factor in the decision by the European Community to continue a moratorium on the commercial use of rBGH. The December 2, 1991 issue of Feedstuffs had an account of the press conference and a summary of the report. In a later issue, citing its article about the Rural Vermont report, Feedstuffs wrote: "EC scientists involved in BST research express a belief, unofficially, that the caution being shown by the Commission has been strongly influenced by reports of trial findings in the U.S., which have claimed to show 'significant health problems' in treated cows. "30
FDA Response to Rural Vermont Report
On November 27, 1991, U.S. Representatives Ted Weiss (D-NY) and Bernard Sanders (I-VT) wrote to Dr. David Kessler, commissioner of the FDA, asking for a comparison of the Rural Vermont data with data they had been given by Monsanto, as well as answers to several other questions. The response was startling.
The FDA report sent to U.S. Reps. Weiss and Sanders revealed three new pieces of information. First, it showed that only one of the four BGH trials conducted at the University of Vermont - the one with Jerseys - had been reviewed by the agency. All of the Holstein test herd data analyzed by Rural Vermont had not been reviewed by the FDA.
Second, the report showed that the Jersey study had seen a huge outbreak of mastitis in the rBGH group - four times as much as in the control group. Two of the 20 controls were treated for clinical mastitis, compared to nine of the 20 treated cows. There was a greater incidence of injection site reactions among the treated cows than among the controls. An injection site reaction is severe swelling and pain at the site of the injections. One of the Jersey cows injected with rBGH had such severe swelling and negative responses to the shots that she had to be removed from the experiment.
- John Dillon, "UVM, Bovine Study Draw Draw Criticism, Legislators: BGH Safety an Issue," Rutland Herald, 18 November 1991.
- Jon F. Schneid, "Vermont Lawmakers Condemn BST; Monsanto Refutes Claim," Feedstuffs, 2 December 1991; Anthony Phelps, "EC to Continue Moratorium on BST at least until 1994," Feedstuffs, 30 December 1991.
The FDA report also summarized the results for reproductive health: "Among cows not pregnant prior to treatment initiation, successful calving rate was 100% in controls and 85% in treated cows. Days open in controls was 88 and 103 in treated cows, and services per conception was 1.7 vs. 2.2, respectively. One treated cow aborted."31
This contradicted years of testimony and public statements by the University and Monsanto that there had been no adverse health effects at UVM. In 1989, UVM and Monsanto worked as a team to promote rBGH to farmers. Monsanto hired a UVM extension expert, Brian Perkins, to run several meetings for farmers in Addison County. He showed a slide show that was produced by Monsanto. The message was that rBGH would increase feed efficiency and milk yield. It would not change the milk. It would not hurt the cow or affect the calf. It would help the family farm .32
At one dinner meeting in 1989 hosted by Monsanto in Middlebury, Vermont, Dr. Winston Samuels displayed a slide in the slide show which suggested that rBGH-treated cows took no longer to conceive than untreated cows. When asked how many cows in the experiment didn't conceive at all, he refused to answer .33
In 1990, John Kunkel, extension veterinarian for the University of Vermont, provided a pro-rBGH resolution to the Vermont Veterinary Medical Association. In one "whereas" clause he wrote, "There is no evidence that BST has any adverse effect on systemic, mammary or reproductive health."34
Following the disclosures in FDA's letter to Reps. Weiss and Sanders, UVM and Monsanto scientists admitted in the December 1992 Journal of Dairy Science that Jerseys injected with BGH suffered a massive outbreak of antibiotic-resistant clinical mastitis. There were four new cases of mastitis in the control group, compared to 29 new cases in the BGH-treated group; and an average of 1.5 days of antibiotic treatment for those in the control group, compared to 8.9 days of antibiotic treatment for the rBGH-treated group.35
This was an incredible admission, given UVM's past assurances about good animal health in its test herd. In a 1988 preliminary report, UVM presented data on somatic cell counts (SCC) which suggested virtually no mastitis in the rBGH group. Somatic cell counts are a measure of dispersed pus cells, and indicate the presence of subclinical mastitis, the beginning stages of mastitis. Dr. Kronfeld summarizes: "These disclosures established that the 1988 preliminary report of Pell [abstract in Journal of Dairy Science, June 19881 was misleading. It presented very low milk somatic cell counts (SCC), in effect claiming little or no subclinical mastitis and by implication no mastitis problem. The data were probably correct, but their presentation was nevertheless misleading."36
The third thing learned from the FDA report was that FDA did not accept Monsanto's "categorization and statistical analysis of these health data because of potential biases in the results when their methods were used."37 The FDA told Congressman Sanders' staff that Monsanto would be resubmitting the health data from at least 11 field trials to conform to a method approved by FDA.
- Holcombe, "Report on Data," 1991.
- Deb Brighton, "'Education' BST marketing tool, UVM Extension expert paid by Monsanto," The Addison Independent, 15 May 1989.
- Deb Brighton, "The Great Hormone Debate, What Would Bovine Growth Hormone Do to Vermont's Dairy Industry?" Vermont Sunday Magazine in the Sunday Rutland Herald and Times Argus, 3 December 1989.
- John R. Kunkel to Vermont Veterinarians, letter and draft resolution, 26 March 1990.
- A.N. Pell et al., "Nutrition, Feeding' and Calves, Effects of a Prolonged-Release Formulation of Sometribove (n-Methionyl Bovine Somatotropin) on Jersey Cows," Journal of Dairy Science, v.75, no. 12 (December 1992) pp. 3426.
- Kronfeld to Christiansen, facsimile transmission, 6 December 1994.
- Holcombe, "Report on Data," 1991.
In 1990, FDA whistle-blower Richard Burroughs warned that FDA had adopted an "approval process" instead of a "review process" for new animal drugs and had, in effect, become an extension of the drug industry.38 As early as 1989, an FDA memo noted that the Veterinary Center Director, Dr. Gerald Guest, was "heavily involved with BST public relations activities." 39
Critics charged that the FDA was abdicating its basic mission to review product safety, while assuming the role of advocate for drug companies seeking approval of products. In a private meeting with the National Milk Producers Federation in 1989, FDA Center for Veterinary Medicine (CVM) Director Dr. Guest revealed his advocacy for Monsanto. Long before the research data had been sent in, Guest noted that "in view of the likely problems with cattle safety and the need for the careful management of the cattle, should the product be prescription?" The memo goes on to ask "whether this might give some sense of security to the consumer?" Guest also wrote: "The real question is how to educate the masses.40
FDA Sabotages an Independent Investigation
Vermont legislators, unaware of Dr. Guest's advocacy of rBGH, had hoped that FDA would launch an independent investigation into the concerns raised by the Rural Vermont report. Instead of greeting the new information with concern and interest, federal regulators went on the defensive.
The correspondence between FDA and Senator Howrigan and Rep. Starr is instructive and significant. The FDA revealed that Rural Vermont's coding of the rBGH cows was quite accurate. Of the 52 cows identified by Rural Vermont as rBGH cows, only nine were challenged by FDA, though FDA suggested it had a great deal more information about cow ID numbers. Of those nine, only one had a lactation curve resembling that of an uninjected control. Eight cows had lactation curves that showed characteristics of rBGH use.
It also became apparent that FDA broke the law defined in its own regulations by leaking, as FDA conceded it had, proprietary information without the permission of the corporate sponsor.41 Furthermore, FDA told the General Accounting Office that it didn't have any of the crucial I.D. numbers for the cows involved in the Holstein rBGH trials at UVM, when in fact FDA had already leaked those numbers to the press. The inaccuracies and omissions in the UVM data, the illegal acts of FDA and the refusal of UVM and Monsanto to cooperate with the GAO highlight a corrupt approval process and suggest complicity in a cover-up.
In their first letter to Dr. Guest, Senator Howrigan and Representative Starr expressed a desire to work together with the FDA. The legislators reminded Dr. Guest of the offer made by FDA's regional director, David G. Field, two years before in May 1989. Under that proposal, FDA would deputize state officials to review rBGH test data under the condition that proprietary information be kept confidential.42
- Keith Schneider, "FDA Accused Of Improper Ties In Review of Drug for Milk Cows," New York Times, 11 January 1991.
- "Richard Burroughs, "Testimony to the Canadian Parliament," 1993.
- Guest to Teske et al., Center for Veterinary Medicine, Interoffice Memorandum, 18 July 1989.
- "Proprietary information" is information that is considered to be a trade secret and therefore must be kept confidential.
- Howrigan and Starr to Guest, 20 November 1991.
Dr. Guest's response came two and a half months later in the now famous "Howrigan letter." Interestingly, it was a letter Senator Howrigan had never received. Instead, FDA gave this letter (which was undated and had no letterhead) to Monsanto. Monsanto then sent copies to the press all over the country. Monsanto gave the letter to members of the Maine Legislature just before a vote on a BGH moratorium, and to Cable News Network (CNN) just before it ran televised segments about the Rural Vermont report.43
In the Howrigan letter, the FDA alleged that Rural Vermont's analysis was affected by errors in cow identification, mistaking nine of the untreated controls for BGH-treated cows. However, an analysis of the lactation curves of these cows calls into question FDA's assertions. Dr. Kronfeld, after reviewing the lactation curves of these cows, wrote that the FDA claim "is not supported by the monthly lactation records of eight of these nine cows; the data revealed bumps in lactation curves (production per month) that are characteristic of BGH administration."44
One of the rejected cows, whose daughter gave birth to a deformed calf, was rejected by FDA because she would allegedly have been dry (not milking) at the time the rBGH experiments began. A second cow, thought to be an rBGH cow whose daughter had a deformed calf, but challenged by the FDA, was identified in the Howrigan letter as a control cow.
However, the lactation curve for this second cow during the time of the experiment, for which she was supposed to have been a control, is conspicuously absent in the university records. The other disturbing omission in the record is the lack of detail in the chronological health record for that lactation. There was only one veterinarian check, yet the cow produced 10,414 pounds of milk over 143 days. This is high production typical of a rBGH-treated cow, and one would have expected more veterinarian checks than this. According to Dr. Alice Pell, control cows that milked less than 168 days were excluded from the studies.45 Given that criterion, how could this cow have been one of the controls?
In the Howrigan letter, the FDA also said it didn't believe any of the Holsteins were injected with rBGH before August 1987. Yet the cow that FDA suggested was an untreated control would have had to have been part of an experiment in the early part of 1987, thus raising questions about when the experiments actually started. If Holsteins were injected with rBGH before August 1987, that would raise the possibility that the first cow dismissed by FDA was actually an rBGH-treated cow as well.
The Howrigan letter, which contained Holstein ID numbers, was written at the same time the GAO was investigating the Rural Vermont report. When Monsanto provided the Howrigan letter to the press, the GAO still had not received any of the ID numbers requested from the FDA. One of the GAO investigators said that even on the day before the Howrigan letter was made public (and 18 days after FDA claimed to have written it), FDA had said that it did not have any of the cow identifiers. A couple of days later, the FDA changed its story1 and said it had found ID numbers for one of the Holstein studies.46
If it was not outright lying to GAO, FDA certainly evinced serious disorganization and confusion - frightening characteristics in a federal agency responsible for the safety of the nation's food supply.
When the Vermont legislators sent the Rural Vermont data sets to FDA's Dr. Guest on November 20, 1992, they wrote: "We have provided you with all of the enclosed data and analysis so that you can verify the information you received from Monsanto against the data and report we provided, and determine whether Monsanto has provided a complete report on the University's experiment." The letter to Dr. Guest stressed the importance of keeping the Rural Vermont data confidential by adding that the legislators were "providing information for your internal review." FDA's inexplicable release of confidential cow identification numbers to Monsanto in the Howrigan letter was both puzzling and disturbing to the Vermont legislators.
- Phone conversation between Andrew Christiansen and CNN, 5 February 1992.
- Kronfeld to Christiansen, 6 December 1994.
- Alice Pell and A. John Bramley, Presentation on bST Research at UVM, Burlington, VT: University of Vermont, Terrill Hall, 9 March 1992.
- Phone conversation between Andrew Christiansen and U.S. General Accounting Office, 8 February 1992.
The consequence of giving Monsanto the critical cow ID numbers from the Rural Vermont data was that any independent review of the UVM data was sabotaged, because any future data provided by UVM or Monsanto would now be suspect. Obviously, if Monsanto knew which cows Rural Vermont had successfully identified as rBGH-injected cows, it could simply reassign those individual cows to the control group. Since the information was confidential, nobody would be aware of the changes except Monsanto and the UVM researchers.
The Vermont legislators telephoned FDA, demanding an explanation for the Howrigan letter. Again they requested deputation of state officials. They also asked under what authority FDA had released the cow ID numbers, since all attempts to acquire them in the past had failed, due to their proprietary nature.
FDA's Richard Teske responded to the legislators on February 26, 1992, saying that Dr. Guest had stamped the letter on January 17 and mailed it a few days later on January 21, 1992. He could not explain why the Senator had not received the letter. He said FDA would not deputize Vermont officials, because "there is no basis or need at this time for the Agency to seek assistance from State officials to review scientific data that FDA may have received in support of pending product approval applications." Teske also said that confidentiality restrictions would prohibit testimony from being presented to a legislative committee, "because the information would not be usable in a state proceeding." He added, "the FDA Commission is likewise inappropriate."
The leaking of the Howrigan letter to Monsanto was described as an accident. FDA's Teske said that Dr. Guest had made the incorrect assumption that Senator Howrigan had released the letter to the press. "On January 31, 1992," Teske wrote, "Dr. Guest received a telephone call from a reporter requesting further information regarding our response to inquiries about the BST research being conducted at the University of Vermont (UVM). The reporter indicated she had a copy of our response (letter) in front of her and proceeded to ask questions based on information in the letter. Dr. Guest believed she was referring to his letter to Senator Howrigan and Representative Starr which he assumed she must have obtained from Senator Howrigan's office. In retrospect however, Dr. Guest now believes that the letter to which the reporter referred was actually our response to U.S. Representative Ted Weiss (which had been included as an enclosure in Dr. Guest's response to Senator Howrigan and Representative Starr). In any case, on February 3, a representative of the Monsanto Co. called indicating that he was aware of the inquiry from Senator Howrigan and Representative Starr and asked if we had responded. We acknowledged that we had. He then explained that there were meetings on the issue occurring in Vermont and asked if he could obtain a copy of the response. Believing that the response had already been made public, we provided a copy to him by facsimile transmission on February 3."
Teske also explained that while FDA was prohibited by current regulations from releasing proprietary information, corporate sponsors, such as Monsanto, could authorize such a release.
Why Dr. Guest made the assumption that Senator Howrigan had released Guest's letter to the press, without first checking with Senator Howrigan, and did not send a copy of the letter to Rep. Starr was the subject of further correspondence. Senator Howrigan and Rep. Starr wrote to Teske on March 20, 1992, specifically asking whether Monsanto had authorized the FDA to release proprietary information in the Howrigan letter. If Monsanto had not given authorization, they asked, wouldn't FDA's seemingly illegal disclosure of a few of the ID numbers force FDA to waive any claim of confidentiality to the entire set of ID numbers?
The April 18 response from Teske to the Vermont legislators said that Monsanto had not authorized the release of confidential information. Teske said the reason FDA had given Monsanto the information was that most of the information had come from Rural Vermont, and just a little bit of it had come from their files. Teske wrote: "The information originally provided by Dr. Guest came in part from data files and printouts provided to us by Senator Howrigan or yourself (the Rural Vermont data) and in part from records we had obtained during an inspection of one of the Vermont studies (as noted in Dr. Guest's original letter). Although that part of the information that came from our files is technically proprietary information, we felt that since the particular information released was only a very small part of the total, it was inconsequential."
In other words, while FDA had technically broken the law, that was OK, because it had only broken the law a little bit. Even more appalling to the state legislators, who had been entrusted with the Rural Vermont data, was that FDA had totally violated the confidential treatment that the legislators had requested for the Rural Vermont data when it was first sent to FDA on November 20, 1991.
Teske continued: "Further, since including the information served to demonstrate our position first of all that there appeared to be inaccuracies in the data provided by Rural Vermont, and secondly that allegations about the effects of BST on the health of the UVM herd can only be resolved by a properly conducted investigation and evaluation of all of the study records from the research, we felt including the information was justified."
Thus, in one fell swoop, FDA's illegal leaking of confidential information to Monsanto, especially that "part" which came from Rural Vermont, eliminated the independent study that Rural Vermont had sought and even made such an investigation impossible.
General Accounting Office Investigates
While FDA was closing the door to an investigation on its part, GAO investigators ran into the same roadblocks as the Vermont Legislature had in securing information from the University of Vermont and Monsanto. After Rural Vermont's November 18 press conference, Rep. Bernard Sanders had been successful in getting the General Accounting Office to begin an inquiry, but GAO failed to get the data necessary to finish its work. The Vermont Legislature and the GAO worked for over 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 test groups remains secret.47
- Eleanor Chelimsky, "rBGH Vermont Review, Chronology of Events," (October 27, 1992). Memorandum from the U.S. General Accounting Office to U.S. Rep. Bernard Sanders.
Eleanor Chelimsky, assistant comptroller of the General Accounting Office, summarized their efforts in a letter to Congressman Bernard Sanders dated October 27, 1992: "As you know, we were unable to acquire the data from either the University of Vermont or from Monsanto ... Consequently, on May 20, 1992, we terminated our effort, in coordination with your staffs. Even though Monsanto continues to offer new proposals, we feel that the inordinate amount of time that has thus far been required to negotiate data acquisition vitiates our confidence in the authenticity of the data." [Emphasis added.] Apparently, the GAO had the same concerns as Rural Vermont about possible tampering with data, and terminated its investigation three months after FDA had given Monsanto the Howrigan letter.
GAO's uneasiness with the data grew when it found inconsistencies between some of its conclusions and Monsanto's public statements. GAO also found that the University of Vermont and Monsanto animal health data sets were not identical. If the data sets were not identical,48 this might imply that Monsanto had changed the data it had received from UVM before giving them to the FDA.
In a separate investigation, released in August, 1992, GAO faulted the FDA guidelines for assessment of indirect human food-safety risks associated with the use of rBGH. "These risks are not covered by the FDA guidelines and have not been addressed for rBGH," the report said. In effect, the increased milk production in cows from the rBGH treatment has triggered an increase in their incidence of mastitis, which would often be treated with antibiotics. As a consequence, higher levels of antibiotic residues in milk and beef could result." It recommended that the milk and meat from rBGH-treated cows be taken off store shelves and no longer marketed. The FDA dismissed these concerns and essentially white-washed the report.49
On March 2, 1993, these recommendations were reiterated and amplified in a letter from GAO's Chelimsky to Health and Human Services Secretary Donna Shalala. In that letter, the GAO took issue with FDA's insistence that current withdrawal requirements for drugs and withholding requirements for food products would ensure that no drug residues would be in the nation's food supply. The GAO believed that current requirements were inadequate to deal with the larger concentrations and types of antibiotics that could be in the milk once rBGH was approved.
In fact, the GAO had earlier declared in a 1990 report that the nation's milk supply might already have been contaminated by antibiotics beyond acceptable levels, because of the inadequacy of FDA testing. The GAO found that the FDA surveys were "not statistically valid and present, at best, 'snapshots in time' of a small number of milk samples tested for the presence of a small number of drug residues."50 The FDA agreed with this assessment, but said it did not have a large enough budget to test for all the drugs that should be tested for Dr. Guest, FDA's director of the Center for Veterinary Medicine, tried to assure the public by announcing that FDA would begin testing for 11 new drugs the following year.51 But the GAO report found that FDA had approved 53 drugs for use on dairy cows, and said 'about 25 drugs, including 12 antibiotics, not approved for use in dairy cows are believed to be used in the dairy industry."52
- United States General Accounting Office, Recombinant Bovine Growth Hormone, FDA Approval Should Be Withheld Until the Mastitis Issue is Resolved, (Washington, D.C., 6 August 1992).
- United States General Accounting Office, Food Safety and Quality: FDA Surveys Not Adequate to Demonstrate Safety of Milk Supply, (Washington, D.C., GAO/RCED-911-26, Nov. 1, 1990).
- Philip J. Hilts, "FDA's Tests on Milk Are Called Inadequate," New York Times, 21 November 1990.
- GAO, Food Safety and Quality: FDA Surveys Not Adequate, 1990.
By 1992, the situation had grown even more grim. Not only did the GAO deem FDA's expanded testing program a failure, saying and the inability to draw 'any statistically valid conclusions about the presence of residues in milk ... raises questions about the value of this program,' but there were nearly twice as many illegal drugs being used by dairy farmers on their cows.53 When GAO looked at drug residues in milk, it found up to 82 drugs that could leave residues: only 30 of the drugs were approved for some use on dairy cows. Some of the others were used under the Extra-Label Use Policy, which requires the supervision of a veterinarian. While these drugs were intended just for special circumstances, the GAO discovered that veterinarians wrote 40 to 85% of their prescriptions for extra-label use. FDA also found, in its inspections in 1990 and 1991, the use of 42 illegal drugs not approved for use in any food-producing animal54 Some of these drugs were used to treat mastitis, including Monsanto's illegal use of gentamicin and tetracycline to treat mastitis in its rBGH trials.55
Dr. Michael Hansen of Consumers Union, in hearings before the Veterinary Medicine Advisory Committee on March 31, 1993, questioned whether FDA could enforce even its own safety standards, given the widespread use of unapproved drugs in dairy cows. He said: 'Of the 82 potential drugs in use, FDA has established tolerances or 'safe' levels for 35; for the remainder, the allowable level is therefore legally zero. Yet state agencies routinely test for only four of these drugs, all in the penicillin family ... FDA has recently expanded its own monitoring program. Yet it tests for only 12 drugs, notifies the dairies in advance of the sampling, and analyzes only 500 or so samples per year. On average, that is less than one sample per state per month. Indeed, reliable tests do not exist for more than a dozen drugs.56
At the end of the letter to Health and Human Services Secretary Donna Shalala, GAO's Chelimsky wrote: "In conclusion, we would like to point out that the increase in mastitis levels reported in the rBGH pivotal studies suggests that the potential for an increase in milk antibiotic levels is very real. The approval of rBGH products should not be forthcoming until the antibiotic risk is validly assessed.57 The Department's response suggests that our recommendations have not been seriously addressed.' The GAO report and Chelimsky's letter were addressed by the FDA's Veterinary Medical Advisory Committee, March 31, 1993, and were, in effect, rejected. The committee digested substantial contributions from the FDA and Monsanto, but paid little heed to contrary opinions.
- United States General Accounting Office, Food Safety and Quality: FDA Strategy Needed to Address Animal Drug Residues in Milk, (Washington D.C., GAO/RCED-92-209) 1992, p.4.
- ibid. p.3-4.
- R.P. Lehmann, Letter from the Director of the Division of Production Drugs, FDA/CVM, to Terrance Harvey, Director, Regulatory Affairs, Monsanto, 3 April 1988. This letter revealed that Monsanto was using drugs outlawed by FDA to treat mastitis in rBGH-treated cows as well as a number of other violations of FDA regulations.
- Dr. Michael K. Hansen, "Testimony Before the Veterinary Medicine Advisory Committee on Potential Animal and Human Health Effects of rBGH Use,' 31 March 1993.
- Chelimsky to Shalala, 2 March 1993, p.4.
The GAO investigations were not the only ones finding holes in the FDA approval process. A federal Advisory Committee on the Food and Drug Administration said that FDA labs and equipment were in abysmal condition. The Advisory Committee also said that some food factories were inspected only once every eight years, and that the agency had inadequate scientific ability to keep up with 'revolutionary advances occurring in the biological and medical sciences."58
This federal inquiry confirmed the statements of the FDA whistle-blower, Dr. Richard Burroughs, who said officials in FDA's Center for Veterinary Medicine (CVM) "suppressed and manipulated data to cover up their own ignorance and incompetence." He said company representatives "would come in and try to negotiate the protocols to water them down ... Then, if things didn't work out in their tests the way they wanted them to, they'd come in, present their data and see what they could salvage that would eventually help them market their product."59, 60
UVM Attempts Damage Control
Following FDA's disclosure of the mastitis outbreak in the Jersey studies and negative newspaper editorials about the unhealthy level of corporate influence at the University of Vermont, a response seemed in order. On March 9, 1992, Drs. Alice Pell and A. John Bramley invited the press to a seminar to discuss the results of UVM's BGH research. They tried to put a better spin on the devastating results, but had to concede that Jersey cows showed a rate of mastitis 450 percent greater than untreated cows, with 725% more new cases of mastitis among the rBGH-treated cows and 85% more injection site reactions.
Pell and Bramley said the 21 Jersey cows were too small a sample to make scientifically sound statements about the effects of rBGH. Dr. Bramley said the higher level of mastitis was partly the result of a higher level of mastitis in the cows before they were treated with the hormone. He said that three of the 21 rBGH-treated cows had been treated for mastitis before the experiment began, compared to one of the 21 control cows. He pointed out that pooled data from 14 other Monsanto studies, which showed increases in mastitis for rBGH-treated cows, also began with the rBGH group having more pre-trial mastitis.
- Robert Pear, "Panel Calls Federal Drug Agency Unable to Cope With Rising Tasks,' New York Times, 11 April 1991.
- Craig Canine, "Hear No Evil, Special Report - In its Determination to become a model corporate citizen, is the FDA ignoring potential dangers in the nation's food supply?" Eating Well, (July/August 1991).
- Dr. Burroughs had been in charge of rBGH review at FDA and was fired when he made statements critical of the process. After a review cleared Burroughs of FDA charges about his work performance, FDA was ordered to reinstate Dr. Burroughs.
If assignments to treatment groups had been done randomly, as good experimental protocol would require, it is hard to believe that every experiment would be so biased. Perhaps researchers were trying to impress their corporate sponsors with higher gains in production rather than good health records. If this were the case, there might have been a temptation to choose cows more likely to be heavy producers and, as the researchers say, more likely to have mastitis.
Similarly, Dr. Pell again presented the same data about reproductive performance (services per conception, days open, calving rate, etc.) that was in the FDA Holcombe report, but emphasized that reproductive efficiency is generally lower in higher-producing cows, and presented larger, pooled studies to make her point. The message that Pell and Bramley seemed to convey was that rBGH makes cows produce more milk and cows that give more milk are more often sick, but rBGH doesn't make cows sick.
One piece of information that was significant was that Dr. Pell confirmed that two of the rBGH treated cows had severely deformed calves, the dipygus (she called it a "set of Siamese twins') and a bulldog calf. She suggested that this not unusual, because the expected incidence of abnormal births is between .5 and 3 percent. The veterinarian hired as a consultant by the Vermont Legislature suggested that one could expect 2% of calvings to be abnormal, but that definition of abnormal calvings included the delivery of all calves born 30 days before the expected due date. The expected incidence of severe deformities such as occurred at UVM is much lower.
Following the March 1992 seminar, UVM was heavily criticized in the press. One editorial summarized the main points of the Pell and Bramley seminar this way: "First, there is the professors' disclaimer. After arguing in February that their research was scientifically valuable, they said last week the study involved too few cows to be significant... Second is the claim that releasing the results would put to rest questions about BST. The researchers' results only supported concern about the hormone's side effects. Cows in UVM's study were almost five times as likely to develop udder infections after BST injections.... Third is that the maker of BST, the Monsanto Corp., sponsored the research at UVM. Since the results call BST into further question, it appears that cloaking the study's results might serve more than the researchers' professional publication purposes ... UVM researchers may have thought that by coming clean about their BST study they would walk away healthy. But it turns out that a questionable association with BST infects more than the cows."61
Later in December 1992, when the UVM Jersey trial results were published in the Journal of Dairy Science, UVM researchers revealed that the rBGH-treated cows had 725% more new cases of mastitis than the control cows. UVM and Monsanto researchers claimed that while the rBGH cows had 29 new cases, compared to four new cases in the control group, 22 of those were the result of a chronic infection called Staphylococcus aureus that the control group did not have. Even if those cases were eliminated, the rBGH cows still had 75% more new cases of mastitis.
The Journal of Dairy Science article also showed that rBGH-injected cows infected with mastitis needed much more antibiotic treatment than control animals with mastitis. The average number of days of treatment was 8.9 days for rBGH cows and 1.5 days for control cows.62
UVM researchers insisted that before conclusions could be drawn from these frightening results, that these data should be pooled with those from other studies. The pooled data for 15 herds, including the UVM herd, were reported in a paper by T.C. White and others in 1994.63 They showed that a 42% increase in mastitis could be accounted for by a 14% increase in milk production. This claim was repeated in the Technical Manual for POSILAC® November 1993, but was withdrawn in a June 1994 revision directed by the FDA, which regarded it as misleading. Even if the the claim of White, Pell and others were true, it would mean that fewer, but sicker, cows would provide the nation's milk supply. This is hardly the type of animal or public health impact one would expect from an FDA approval of a new drug.
14 March 1992.
- Burlington Free Press,
A.N. Pell et.al., 'Effects of a Prolonged-Release Formulation of Sometribove on Jersey Cows," Journal of Dairy Science (December 1992). T.C. White, D.E. Bauman et.al., 'Clinical Mastitis in Cows Treated With Sometribove (Recombinant Bovine Somatotropin) and its Relationship to Milk Yield,' Journal of Dairy Science, 77, no.8 (August 1994): 2249-2260.
This cartoon and the quotation below it appeared in an advertisement in the June 30, 1947 edition of Time Magazine.
"The great expectations held for DDT have been realized. During 1946, exhaustive scientific tests have shown that, when properly used, DDT kills a host of destructive insect pests, and is a benefactor of all humanity."
The White paper was useful in that it revealed other examples of misreporting by professors funded by Monsanto. In 1988, Dale Bauman, a Cornell professor and Monsanto consultant, reported in an abstract that health variables were not affected by POSILAC® in its first trial. He wrote: 'No adverse health effects were observed... [a]nimals were in good health throughout the study.64 In fact, clinical mastitis was observed in 35% of the POSILAC®-treated cows, but only 10% of the controls. The increased mastitis incidence was statistically significant and medically serious.
- D.E. Bauman et al, 'Long-term evaluation of a prolonged release formulation of N-methionyl bovine somatotropin, Journal of Dairy Science, 89, (1989): 642-651.
The low mastitis incidence in the control cows demonstrated good management in the Cornell herd, as it had in UVM's. The mastitis outbreaks showed that normally effective, mastitis-prevention programs no longer work when rBGH is administered - indeed, good management appears to make cows vulnerable to mastitis when given the drug. Yet, Bauman suggested to the FDA in 1987 that management positively influences herd responses to the drug' and the FDA has allowed such statements on written materials for POSILAC® The influence of Bauman and Monsanto on the FDA was strengthened by the appointment of Bauman's former graduate student, Suzanne Sechen, as the FDA's Principal Review Officer for rBGH in 1988. She apparently shares her mentor's view that all of the problems associated with the use of rBGH can be exquisitely coordinated, so the drug can have no adverse effects - just manageable side effects. Such a mind-set would be impervious to warnings.
FDA Dismisses All Warnings On Milk Safety
In March 1993, the FDA's Veterinary Medicine Advisory Committee was assigned the task of determining whether the use of rBGH presented a hazard for human health. The panel conceded that cows treated with Monsanto's rBGH had statistically significant higher levels of mastitis, but that these fell within "acceptable limits." They also concluded that there were adequate safeguards in place to prevent unsafe levels of antibiotic residues from entering the milk supply.65
Having admitted that the 1990 GAO study was accurate in describing FDA's monitoring effort for drug residues in milk as deficient, the FDA started testing for a few more drugs. The FDA ignored, however, GAO's updated version of that report in 1992. The 1992 GAO report showed that FDA's expanded test program was a failure. It also found that the number of illegal drugs thought to be used on dairy farms had risen from 25 to 42.
On May 7, 1993, the Veterinary Medicine Advisory Committee was joined by the FDA's Food Advisory Committee for two days of discussion about the labeling of foods derived from BGH-treated cows. Dr. Hansen pointed out that FDA's Center for Veterinary Medicine (CVM), by ignoring its own findings about mastitis in rBGH cows, was also ignoring its own criteria for what was safe.66 The use of a "manageable risk" standard also violated the FDA policy that required new animal drugs to be safe for labeled uses.' These FDA committees were unable to reach any conclusions.67
FDA Approves Monsanto's POSILAC®
On November 5, 1993, the Food and Drug Administration announced approval of Monsanto's BGH product, to be marketed under the trade name POSILAC® Sale of POSILAC® was delayed 90 days to comply with the moratorium that was included as a provision in the Omnibus Budget and Reconciliation Act (OBRA) passed by Congress in August 1993. Voluntary labeling was allowed as long as it wasn't misleading. As part of OBRA, the administration would complete a study of the economic and social effects of BGH use before the 90-day moratorium expired.68
- Gregory N. Racz, "FDA Panel Finds Hormone Safe for Milk,' Wall Street Journal, 1 April 1993.
- Michael K. Hansen, Testimony Before the Joint Meeting of the Food Advisory Committee & the Veterinary Medicine Advisory Committee on Whether to Label Milk From rBGH-Treated Cows, 6 May 1993.
- Philip Elmer-Dewitt, "Udder Insanity, A Battle is Raging Over the Safety of Milk from Cows Treated With a Genetically Engineered Hormone,' Time v.141, no.20 (17 May 1993) p.52.
- Keith Schneider, "FDA OKs Hormone for Milk Impact: It's the First Time Genetic Engineering of Food Has Been Allowed,' New York Times, 6 November 1993.
In January 1994, the Clinton Administration released its report on the social and economic effects of BGH. While affirming the FDA decision about the safety of the product, it also estimated that federal dairy price support program costs would increase by approximately $150 million in FY 1996, while farmers would see their incomes decline. In FY 1997-99, the report said, 'aggregate farm income with BST would range from $250-$680 million lower."69
On February 3, 1994, Monsanto began its sales of POSILAC® and on February 7, FDA released its interim guidelines on labeling of milk products.70
The guidelines, though advisory only, strongly recommended that dairy products could not be labeled "rBGH-free," but would have to say that the milk came from cows "not treated with rBGH." Labels would also have to include a statement such as, 'No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows."71 This unprecedented suggestion from FDA that product labeling should endorse other products and validate FDA decisions created a great uproar, particularly for companies planning to sell rBGH-free products and states considering labeling legislation.
A month later, in March 1994, U.S. Rep. Bernard Sanders discovered that Michael R. Taylor, who had approved the labeling guidelines, was a former lawyer for Monsanto. Although he had followed correct procedures by disqualifying himself from such decisions for a year, one wonders if he could entirely ignore the seven years he worked for King & Spaulding' the law firm that represented Monsanto, and the personal legal work he did for Monsanto that was listed on his resume.72
The General Accounting Office found that two other FDA employees, Dr. Margaret Miller and Susan Sechen, had violated ethics rules 11 times. They were both involved with FDA's technical review of Monsanto's rBGH, but they had also been researchers employed by Monsanto. Even while employed at the FDA, they published articles for Monsanto. As the primary data reviewer for Monsanto's rBGH application, Ms. Sechen was in a position of reviewing her own rBGH research work along with that of Dr. Dale Bauman, who was her advisor at Cornell University. While working under Bauman, she had a temporary job at the FDA developing the guidelines under which Monsanto's rBGH application would be reviewed. "Her actions raise questions about the objectivity that she would be able to bring to her review of these articles,' the GAO observed.73
Monsanto's Huge Investment in POSILAC®
This was not the first time that questions had been raised about the action of Monsanto researchers. For years, Monsanto and its collaborating universities have manipulated the flow of information, rushing to print positive results but delaying for years any negative findings .74
- Office of Management and Budget, Use of Bovine Somatotropin (BST) in the United States," (Washington, D.C., January 1994).
- "Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin,' Docket No. 94D-0025 (Food and Drug Administration: 7 February 1994).
- Keith Schneider, "Question Is Raised on Hormone Maker's Ties To F.D.A. Aides," New York Times, 18 April 1994: Bill Lambrecht, St. Louis Post-Dispatch, 2 March 1994.
- United States General Accounting Office, Letter to U.S. Reps. George Brown, Jr., David Obey, and Bernard Sanders discussing alleged conflict of interest of three FDA employees in review of Monsanto's rBGH product, POSILAC® 19 October 1994. p.18.
- For a review of Monsanto's flawed research and cover-up of damaging results, see Carol Van Strum and Paul Merrell's article, "Dioxin Human Health Damage Studies: Damaged Data?," Journal of Pesticide Reform, vol.10, No. 1, Spring 1990.
In the fall of 1981, Monsanto began a production trial at Cornell University headed by Dr. Bauman. The contracts allowed the right to publish, but gave Monsanto influence over the timing. In 1985, Monsanto published the glorious results of the Bauman study, which found a 41 percent increase in milk production: yet it delayed for years the publishing of less flattering results from replicate studies in Mississippi and Missouri .75
The FDA later asked Dr. Baumann to be the key reviewer of its "independent' summary of the health safety literature published in Science magazine in 1990. That report, intended to allay consumers' concerns about rBGH, raised fears about IGF-1, a protein, found in higher concentrations in the milk produced by rBGH-injected cows. If IGF-1 survives digestion intact, it is more likely to cause allergic reactions in people. The FDA said that IGF-1 is broken up when eaten and is therefore safe. Critics point out that safety is not assured, because the IGF-1 used in the FDA studies was free of the normally attached carrier proteins that help it survive digestion. FDA provided only truncated summaries of the data behind the cited studies, thus precluding independent review .76
It is no surprise that Monsanto would mount a great effort to control information on rBGH, a product in which it has invested huge sums. In 1979, Monsanto paid Genentech $990,000 for the rights to rBGH, along with an agreement to pay royalties and make milestone payments. By 1990, Monsanto had spent an estimated $300 million on the hormone, including $50 million for a manufacturing plant. Analysts estimated that Monsanto was then spending $50 million per year on rBGH.77
New Safety Questions Emerge
Since 1991 when the results of the Rural Vermont report were first announced, even more evidence has come forward to verify its accuracy. British epidemiologists Brunner and Millstone et al., looking at Monsanto's own data, found a significantly increased somatic cell count (SCC) in rBGH-treated cows. An indicator of mastitis, SCC was found to increase in the latter part of a rBGH-treated cow's lactation. In the Monsanto reports of these experiments, the last part of the lactation was omitted. Needless to say, Monsanto's studies report a more cheery result .78 Monsanto has suppressed all attempts to publish the Brunner-Millstone paper.79
Finally, the most grand verification and celebration of the Rural Vermont report imaginable was written by Monsanto itself. All of the health problems described in the report are included on the POSILAC® label's list of side effects.
Dr. David Kronfeld wrote: "The POSILAC® package insert confirmed that the Rural Vermont report correctly identified six of the 21 side effects:
retained placentas and uterine infections ('disorders of the uterus' in the POSILAC® language), '1 hoof rot ('disorders of the foot'),
foot/leg injury ('enlarged hocks and lesions ... of the knee'),
- abomasal surgery ('indigestion'), and
- increased medication ('increased frequency of use of medication').
'Monsanto's scientists and academic consultant-contractees, notably those at UVM and Cornell, have repeatedly denied such adverse health effects of BGH, and their failure to tell the whole truth has been confirmed by the side-effects listed on the package insert of POSILAC®"80
Were it not for the Rural Vermont report, he effects of rBGH on animal health would probably never have been known. A contract between UVM and Monsanto for one of the Holstein studies, dated November 11, 1987, was extended year by year to avoid disclosure. The terms of the contract mandate that any release of information on the project or even an outline of the project must first be cleared with Monsanto. Provision 5.7 says 'ALL MONSANTO information must be returned by UNIVERSITY and/or PI to MONSANTO at termination of the PROJECT, at MONSANTO's request."81
One wonders what would have appeared on the POSILAC® label if there had not been a report from Rural Vermont as most of the illnesses discussed in the report were not in the scientific literature, were denied by Monsanto, and had been carefully massaged into statistical oblivion.
- David S. Kronfeld, 'Somatotropin: First do no harm,' Feedstuffs, 22 June 1987, p.8.
- Michael K. Hansen, Ph.D., Biotechnology & Milk, Benefit or Threat? An Analysis of Issues Related to bGH/bST Use in the Dairy Industry, " (Consumer Policy Institute, Mount Vernon, New York: 1990) pp.6-7.
- 'Keith Schneider, "Betting the Farm on Biotech,' New York Times Magazine, 10 June 1990.
- Andy Coghlan, "Milk Hormone Data Bottled Up For Years," New Scientist (22 October 1994).
- Kronfeld to Christiansen, 6 December 1994.
- Contract between Monsanto Company, Animal Sciences Division and the University of Vermont, Dept. of Animal Science, 11 November 1987.
Conclusions and Recommendations
The 1991 Rural Vermont report and subsequent events exposed the misinformation coming from academic institutions and corporate sponsors about a product that will find its way into much of the food we eat. While universities and drug companies were asserting the safety of rBGH, Rural Vermont was the first to report the true extent of its dangers for animal health. The failure of the FDA to adequately supervise and oversee rBGH experiments calls into question the rBGH approval process.
For years, the University of Vermont had reported seeing few health problems in its rBGH-injected cows. In 1991, following release of the Rural Vermont report, FDA revealed to U.S. Reps. Weiss and Sanders that there had been a massive outbreak of mastitis in the first rBGH trial at UVM. Four hundred fifty percent more cows in the rBGH group had been treated for mastitis than in the control group, and the rBGH group had 725% more new cases of mastitis. FDA's own summary of many pooled studies showed that cows receiving rBGH had a 79% greater risk of getting mastitis than untreated cows. The U.S. General Accounting Office also concluded that rBGH increased the incidence of mastitis. Indeed, the POSILAC® label lists 21 health problems associated with the use of rBGH, six of which were identified in the Rural Vermont report.
Given the acknowledged increase in mastitis and its treatment by a wide range of antibiotics, it's remarkable that neither Monsanto, the universities nor FDA required further research focusing on mastitis.
A 1992 GAO investigation reported: "There was no requirement within the FDA guidelines to examine indirect effects such as those of antibiotic-treated mastitis or antibiotic levels in milk and their potential effect on human health. In talking to FDA officials, we learned that indirect effects were not required to be examined in the investigational drug review process."82
Larry Smith, a professor at Ohio State University, spoke at the critical Veterinary Medicine Committee meeting in March 1993, as a Monsanto consultant. As one of those who was successful in convincing the FDA to approve POSILAC® he argued that mastitis was a manageable risk, but a few months later he said, "There has not been a BST trial run yet where the primary motivation was to evaluate mastitis."83 Smith also said that "given a year's time, 200 to 300 cows spread over three locations and $200,000, you could do a pretty nice trial."84 One can only wonder why after the hundreds of millions of dollars spent on rBGH, such studies weren't conducted. One reason could be that the drug companies were less concerned about animal health than with the efficacy of the drug: in other words, whether it makes cows give more milk. The second reason was that FDA did not require a mastitis study.
The failures and inconsistencies of the FDA's approval process, as determined by the U.S. General Accounting Office, call into question the FDA's whole rBGH approval process. Rural Vermont believes that Congress and the President should require the FDA to rescind its approval of Monsanto's rBGH product. The incidence of rBGH-related mastitis and other animal health problems should be scientifically determined, and an improved system to monitor antibiotics in the nation's milk supply should be implemented.
The Rural Vermont report found that rBGH-injected cows had more illnesses, infections, injuries and reproductive problems than untreated cows, and more severely deformed calves. Independent researchers who looked at Monsanto's data on somatic cell counts, which is an indicator of mastitis, have been prohibited from publishing their conclusions. Though initially denied by Monsanto, all of the health problems noted in the Rural Vermont report have since been included on Monsanto's label for POSILAC® Never before has an animal drug had so many side effects as this one. The evidence strongly suggests that POSILAC® should be reevaluated for its effects on animal safety.
Second generation rBGH products that were tested at UVM will someday be brought to market. The Rural Vermont report elicited information from the FDA that when Monsanto tested new rBGH products (for which the company has not yet sought FDA's approval), there was no monitoring of the experiments. No reports on animal health were required to be sent to FDA. Amazingly, milk and meat from those experiments were allowed to be sold for public consumption.
Before approving the consumption of experimental milk and meat from cows treated with new rBGH products, FDA should conduct exhaustive studies on the animal health effects of rBGH.
The Rural Vermont report also led to the revelation, through the Congressional inquiries that followed, an alarming degree of incompetence, bias and deception within the Food and Drug Administration. Not only did FDA have a track record of corruption and approval of dangerous products; but with rBGH, documents show that FDA became almost an extension of Monsanto. First, FDA worked with Monsanto and the dairy industry to try to figure out the best way to market rBGH in order to minimize consumer backlash. Second, FDA broke the law by leaking proprietary information without the sponsor's authorization, while telling Congressional investigators that it did not have any of that information. Third, FDA gave confidential information from the Rural Vermont data to Monsanto, enabling the company to cover-up damaging health effects from its rBGH trial at the University of Vermont.
- U.S. General Accounting Office, Recombinant Bovine Growth Hormone, FDA Approval Should be Withheld, 1992.
- Jim Dickrell, "The BST-Mastitis Maze,' Dairy Today, October 1993, p.6.
To ensure a truly independent review of new drugs and food products, it seems essential that administrative personnel at FDA be replaced. More stringent conditions should be placed on drug reviewers and regulators. In particular, conflict-of-interest regulations should be strengthened. Current regulations that prohibit employees who have worked for a regulated industry to refrain from decision-making on that industry for one year should be amended to prohibit decision- making for at least five years.
The FDA's approval process has been compromised by an attitude among legislators and politicians which seems to say that "biotechnology is above the law.' Because rBGH is positioned as a flagship product for the biotech industry, and because biotechnology is widely and uncritically accepted as a major engine of economic development and global competitiveness in the next century, regulators seem to have developed a mind-set that makes approval of biotech products a foregone conclusion.
Given the repeated failure of the FDA to impartially evaluate rBGH and other products, as chronicled in numerous GAO reports, it is important, should rBGH continue to be approved, that consumers at least be given a choice. FDA should affirm consumers' right to know by requiring that all products be labeled if they contain rBGH, and that sales of rBGH be registered.
Soon, POSILAC® will not be the only biotech product on the market. Already, rBGH implants are being planned for use in beef cattle. A plethora of genetically engineered foods wait in the wings; the genetically engineered "FlavrSavr' tomato has already been approved.85 The question for the future, should labels be denied, will be whether consumers have any choice at all about what foods they can eat. The answer to that question could very well be determined by what happens with recombinant BGH over the next couple of years.
- Philip Elmer-Dewitt, "Fried Gene Tomatoes," Time, 26 May 1994.
Support for labeling and consumer choice has come from citizens themselves, who have forced reluctant action at the state level. Maine, Minnesota, Wisconsin and a number of other states have set standards for voluntary labeling of rBGH-free products, and Vermont has become the first state to pass a mandatory labeling law for products containing rBGH. At the local level, 87 school districts have enacted policies stating that they will not accept milk from cows injected with rBGH.
Closer scrutiny of corporate-academic ties is essential if people are going to have confidence in the research behind new food products. Citizens must debate and decide how information is controlled and 'owned,' particularly in this new age of biotechnology.
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