Rbgh: How Artificial Hormones Damage The Dairy Industry And Endanger Public Health

rBGH How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

About Food & Water Watch Food & Water Watch is a nonprofit consumer organization that works to ensure clean water and safe food. We challenge the corporate control and abuse of our food and water resources by empowering people to take action and by transforming the public consciousness about what we eat and drink. Food & Water Watch works with grassroots organizations around the world to create an economically and environmentally viable future. Through research, public and policymaker education, media and lobbying, we advocate policies that guarantee safe, wholesome food produced in a humane and sustainable manner, and public, rather than private, control of water resources including oceans, rivers and groundwater. Food & Water Watch Main office: 1616 P St. NW, Suite 300 Washington, DC 20036 tel: (202) 683-2500 fax: (202) 683-2501 [email protected] www.foodandwaterwatch.org

California Office: 25 Stillman Street, Suite 200 San Francisco, CA 94107 tel: (415) 293-9900 fax: (415) 293-9908 [email protected]

Copyright © June 2009 by Food & Water Watch. All rights reserved. This report can be viewed or downloaded at www.foodandwaterwatch.org.

rBGH 101 How Artificial Hormones Damage the Dairy Industry and Endanger Public Health Introduction...................................................................................................................................................................1 Behind FDA approval of rBGH..................................................................................................................................................2

FDA ignores and denies possible health impacts..........................................................................................................2



Conflicts of interest?.....................................................................................................................................................3

What the Science Tells Us Now: Post-Approval Studies of rBGH...........................................................................................4

Animal welfare..............................................................................................................................................................4



Antibiotic resistance......................................................................................................................................................5



Hormonal effects in humans........................................................................................................................................5



Harming human reproduction?....................................................................................................................................5

Why rBGH? Growth Hormones and the Push to “Get Big or Get Out”.....................................................................................6 Labeling......................................................................................................................................................................................7 rBGH Has a New Owner.............................................................................................................................................................8 Community Responses to rBGH................................................................................................................................................10 Take Action................................................................................................................................................................................11 Endnotes..........................................................................................................................................................12

Injecting otherwise healthy cows with genetically engineered growth hormones is, in my view, unnatural, unnecessary and unfair to dairy cows. … Consumers should be able to decide for themselves whether or not they buy milk from rBGH-treated cows. We believe if they had the information to make the choice, they will not. – A representative of Ben and Jerry’s Homemade, Inc., on filing a lawsuit in 1996 to label their products rBGH-free

Introduction

R

ecombinant bovine growth hormone (rBGH), also called recombinant bovine somatotropin (rBST), is a drug that is injected into cows to increase their milk production. Developed by the agricultural company Monsanto and approved for commercial use in the United States by the Food and Drug Administration (FDA) in 1993, by 2000 it had become the largest selling pharmaceutical product in the history of the dairy industry.1 RBGH has never been approved for commercial use in Canada or the European Union due to concerns about the drug’s impact on animal health.2 The artificial hormone’s known side effects include increased udder infections and reproductive problems in cows. Notably, a growing body of scientific research also suggests a link between drinking rBGH-treated milk and certain types of cancer in humans. Consumer pressure on dairy companies to abandon the use of this controversial drug has resulted in an increasing number of companies moving to rBGH-free milk and making sure that consumers know they’ve made the change by labeling their products as such. But across the country, legislators and state regulators are responding to industry pressure by trying to ban rBGH-free labels on dairy products. After years of successful campaigns that educated dairy consumers about the risks of rBGH, banned rBGH milk in some school districts, and pressured major national companies to go rBGH-free, we are at risk of losing the right to know how our milk was produced.

This report will begin with a background on the science, regulation and politics of rBGH, new risks identified by scientific research, the influence of Monsanto, and information on drug giant Eli Lilly, the new owner of rBGH. We’ll tell the stories of successful community, state, and national campaigns to kick the dairy industry off the rBGH wagon. And we’ll finish up with suggestions for action that will help readers become advocates for improving the health and safety of the dairy supply.

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

Behind FDA Approval of rBGH FDA approved rBGH for commercial use on November 5, 1993, despite lingering controversy over the safety and health impacts of the drug. RBGH was the first genetically engineered organism that FDA had ever approved.3 The integrity of the rBGH approval process has been the subject of considerable investigation and concern due to fears that the agency ignored possible health risks of the synthetic hormone as well as potential conflicts of interest with several FDA employees who had ties to Monsanto.

FDA ignores and denies possible health impacts of rBGH Monsanto submitted preliminary materials on rBGH to FDA in 1981 and followed with an official application in 1987.4 The FDA first stated that rBGH posed no human health risks in 19855 and completed the official human health study in 1989.6 Before approving rBGH for commercial sale and use in 1993, FDA approved the drug “for research only” but allowed milk from rBGH-treated cows to be sold and consumed during the commercial investigation.7 Monsanto was not the only company to petition FDA for approval of its rBGH drug — competitors at the time included Eli Lilly, American Cyanamid and Upjohn — but FDA only approved Monsanto’s “Posilac” brand.8 Outside observers first expressed concern that FDA was ignoring the negative animal health impacts of the artificial hormone early on in the approval process.9 Central to their concern were studies suggesting that rBGH use increased the frequency of mastitis, an infection of the cow’s udder that requires treatment with antibiotics. These conclusions were initially downplayed by Monsanto,10 and FDA denied them as late as 1993, when Gerald Guest, Director of FDA’s Center for Veterinary Medicine and the person who had the final say on rBGH’s approval,11 testified in a hearing that rBGH did not increase the severity or duration of mastitis in cows.12 FDA also took a cursory look at the human health impacts of drinking milk produced with rBGH. FDA initially concluded that the drug was safe for humans based on rat studies submitted by each of the four sponsor companies, as well as experiments conducted in the 1950s, in which rBGH did not produce any growth when injected into children with dwarfism.13 FDA only began to look at secondary health issues caused by a related hormone called IGF-1 in 1988, after the agency learned that human and bovine versions of the growth hormone were identical (see “Hormonal effects in humans” on page 5).14 However, according to the Inspector General audit of the rBGH review, the FDA relied on infor-

2

mation provided by the sponsor companies when it determined that exposure to increased levels of IGF-1 was safe.15 One scientist at FDA who did speak up and question the approval process of rBGH was subsequently fired. Richard Burroughs was a veterinarian at FDA and worked on the review of rBGH from 1985 until 1988, when he was terminated, allegedly for incompetence.16 Soon after his termination, Burroughs became a vocal public critic of FDA’s review of rBGH, and stated that he was fired after a dispute with his superior about how to interpret the sponsor companies’ studies.17 Burroughs alleged that FDA was working too closely with industry, Monsanto was manipulating data that it submitted, and FDA was ignoring safety problems with the drug.18 In 1991, the Federal Merit Systems Protection Board found that Burroughs was improperly terminated because the agency had not followed the formal rules in firing him, and it subsequently ordered FDA to reinstate him.19 Burroughs’ allegations were serious enough that at the prompting of Congress, the General Accounting Office (GAO, now the Government Accountability Office) conducted an in-depth investigation into FDA’s review of the rBGH application.20 The GAO recommended that FDA’s approval be delayed until further studies could be performed on the drug’s health effects, particularly regarding the indirect effects of mastitis in treated cows.21 The GAO was already concerned about the levels of animal antibiotics that were making their way into humans through milk consumption,22 and the increased levels of antibiotics that would be

Food & Water Watch used to treat mastitis could potentially lead to even greater levels of antibiotic residue in milk.23 The FDA, however, disagreed and reaffirmed its initial conclusion that the artificial hormone was safe.24 Unfortunately, consumer, farm and animal welfare groups could not directly critique the studies submitted to FDA by the four companies and reviewed by the GAO. In FDA drug approvals, company studies are generally considered proprietary business information and are therefore confidential. It is therefore impossible for the public to know which studies and what data FDA bases its decisions on until after the decision is made, and even then, the specific data generally remain confidential. While the GAO report criticizing FDA’s approval process had access to the FDA studies, it could not present the specific data to the public in order to back up its assertion that there were indirect human health impacts from increased mastitis in cows treated with rBGH.25

Conflicts of interest? FDA’s analysis of the human health impact of rBGH was not the only cause for alarm during the review process. Three FDA employees working on the synthetic hormone application appeared to have such close ties with rBGH manufacturer Monsanto that at the request of Representatives George Brown from California, David Obey from Wisconsin and Bernie Sanders from Vermont, the GAO investigated them for conflicts of interest.26 Michael Taylor, the first target of the GAO probe, started his career in 1976 as an attorney with FDA before leaving in 1981 to join the law firm of King & Spalding.27 While at King & Spalding, one of Taylor’s clients was Monsanto,28 and Taylor drafted a memo for Monsanto on whether it would be constitutional for states to adopt different rules regarding the labeling of rBGH.29 Taylor left King & Spalding in 1991 to join FDA as the Deputy Commissioner of Policy,30 where he helped draft FDA’s guidance on labeling of rBGH31 that helped prevent dairies from labeling their products “rBGH free” (see “Labeling” on page 7).32 Despite the fact the Taylor worked on rBGH labeling issues at Monsanto and again at the FDA, the GAO did not consider this to be a conflict of interest. Since the GAO felt that the guidance was not a “binding agency decision,” it was thus not covered by the impartiality standards and therefore completely excluded from GAO analysis.33 Taylor, who was also responsible for FDA’s earlier guidance stating that there was no need to label genetically modified foods,34 eventually left government service in 199835 for a position as vice president for public policy at Monsanto.36 The GAO also investigated Margaret Miller, a former employee of Monsanto. While at Monsanto, she was responsible for putting together animal safety studies on rBGH.37 She left Monsanto in 1989 and immediately went to work for FDA. 38 In 1991 she was promoted to director of the division of toxicology and environmental sciences, the division that was directly involved in the technical review of rBGH,39 and she later became chief of a branch that was responsible for reviewing the human health impacts of rBGH. 40 According to the GAO, she did not technically violate any conflict of interest rules, despite the fact that she did perform some work related to rBGH.41 The third FDA employee that the GAO investigated was Dr. Suzanne Sechen, who worked on Monsanto-funded rBGH studies while in graduate school at Cornell before leaving in 1988 to join FDA as an animal scientist and the primary reviewer of rBGH.42 Sechen’s faculty advisor at Cornell performed consulting for Monsanto, and the research Sechen performed was conducted pursuant to an agreement be-

3

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

What the Science Tells Us Now: Post-Approval Studies on rBGH Since FDA’s approval of rBGH in 1993, additional research has raised further questions about the wisdom of the agency’s decision. The animal welfare problems found in pre-approval studies remain a major concern. The scientific community also understands more now about impacts “beyond the barn” — how treating dairy cows with a synthetic growth hormone might impact human health. Some studies suggest that rBGH use puts human health directly at risk by altering hormone levels in the humans that consume the cows’ milk, and that it indirectly impacts human health by driving the emergence and spread of antibioticresistant strains of bacteria.

Animal welfare Following the uproar over its decision to approve Posilac for commercial use, FDA required Monsanto to label its product with a disclaimer listing the many effects that Posilac may have on cows. These include reproductive impacts — lower birth rates and birth weights of calves – as well as physical ailments such as mastitis and hoof and leg problems.47 A total of 16 different animal health impacts were listed on the Posilac package insert.48

tween her advisor and Monsanto.43 Monsanto also provided support for several rBGH studies to be performed at Cornell, and some of these were submitted with the rBGH application as pivotal studies.44 During Sechen’s time at FDA, she performed a considerable amount of work on rBGH, including publishing articles on the drug in outside journals based on her former research, and then evaluating several of those same articles in her official capacity as a reviewer of the artificial hormone application.45 Yet the GAO found that she did not have a conflict of interest since Monsanto had never employed her or directly given her funding.46 Despite multiple ties between FDA and Monsanto, the GAO failed to address a relevant question in its report: why did FDA approve Monsanto’s version of the rBGH drug over the other three manufacturers? Given that three FDA officials with former ties to Monsanto were the subjects of the investigation, the exclusion of this area of inquiry from the GAO report is curious. Unfortunately, this sheds no light on why FDA picked Monsanto over the other applicants.

4

In the years following rBGH’s approval, additional studies have backed up these findings. The Canadian Veterinary Medical Association convened an expert panel in 1998 to review the science on rBGH and found a number of impacts on cows’ reproductive performance. The use of rBGH substantially increased the risk that cows would not be able to conceive, but some evidence suggested that it also increased the chance that a cow would bear twins or triplets. There was also evidence of increased risk of cystic ovaries.49 A 1999 study published by the European Commission’s Scientific Committee on Animal Health and Animal Welfare found that pregnancy rates in rBGH-treated cows fell by between 7 percent and 27 percent compared to cows not treated with the synthetic hormone.50 The Canadian veterinary experts found that as a consequence of these and other health impacts of rBGH, including evidence that treated cows experienced a 50 percent increase in the risk of lameness compared to cows that were not treated, rBGH increased the chance that some cows would be culled, or pulled from the herd and slaughtered.51 Both Canada and the EU refused to approve the drug because of outstanding questions related to animal welfare.52

Food & Water Watch Antibiotic resistance The increased frequency of mastitis, an udder infection, is one of the main animal welfare impacts of rBGH use and is included in the warning label on Posilac.53 In addition to causing the cows pain, mastitis has a secondary effect: it requires treatment with antibiotics, and increased antibiotic use in animal agriculture has been linked to the development of antibiotic-resistant bacteria that can sicken humans.54 Many of the antibiotics commonly used to treat mastitis in cows are human-use antibiotics, including drugs from the penicillin and erythromycin classes.55 When rBGH increases the frequency of mastitis in dairy cows, producers may have to increase their use of antibiotics.56 Antibiotic use in dairy operations exposes bacteria to the antibiotics, contributing to the development of drug-resistant bacteria.57 As antibiotic-resistant bacteria spread, they can be transferred to humans through the water or air,58 by flies,59 or on the meat that humans consume.60 The U.S. Institute of Medicine has identified antibiotic resistance as one of the key threats to health in the United States and the federal Centers for Disease Control and Prevention has identified resistance as a top concern.61 Researchers are also concerned about the potential for antibiotic residues to show up in the milk of cows being treated with the drugs. Antibiotic residues in milk are a significant concern when dairy farmers or veterinarians use antibiotics in ways other than that directed on the label,62 a practice that the GAO has called “routine.”63 Indeed, the FDA’s failure to consider the effect rBGH use might have on antibiotic residues in milk was one main reason the GAO recommended withholding approval.64 It is hard to know what portion of overall antibiotic use takes place on U.S. farms and ranches because the federal government does not track it, but estimates suggest that as much as 70 percent of all antibiotics used for any purpose in the United States are fed to animals that are not sick, used as growth promoters or to keep them from becoming ill.65 Treatment of cows for mastitis would be in addition to this number. Anything we can do to reduce the use of antibiotics on animals will help reduce the spread of antibioticresistant bacteria, including ending the use of rBGH in dairy production.

Hormonal effects in humans There is little evidence that rBGH itself impacts humans when they drink milk from treated cows, but rBGH does appear to put human health at risk by increasing the levels of other chemicals that are linked to human illness. When

Recent research shows that when present in the human body at elevated levels, IGF-1 increases the risk of breast, colon, prostate and other cancers. dairy cows are treated with rBGH, their bodies increase production of a protein called insulin-like growth factor-1 (IGF-1).66 IGF-1 circulates in cows’ blood and makes its way into the animal’s milk;67 it appears to survive pasteurization and is consumed by humans when they drink the milk.68 Humans naturally produce their own IGF-1, and they also consume IGF-1 in the milk of cows not treated with rBGH. However, because rBGH increases the amount of IGF-1 that cows produce, humans drinking milk from treated cows will consume more IGF-1 than they otherwise would. What could that mean for human health? A lot, as it turns out. The early research used by FDA to review Posilac suggested that even if humans ingested IGF-1 from treated cows’ milk, the human digestive process would destroy it. But more recent research indicates that most IGF-1 actually survives digestion. IGF-1 binds to casein, the main protein in milk, and may be absorbed into the human bloodstream along with it.69 Recent research also shows that when present in the human body at elevated levels, IGF-1 increases the risk of breast, colon, prostate and other cancers,70 although scientists still do not fully understand why. The American Nurses Association determined that the risk to human health was serious enough to warrant the passage of a resolution in 2008 calling for hospitals and healthcare organizations to eliminate the purchasing of dairy products from rBGH-treated cows and to educate nurses on the effects of rBGH.71

Harming human reproduction? It is well known that rBGH impacts cows’ reproductive systems, but new research suggests that IGF-1 may also affect human reproduction. A 2006 study comparing women who consume dairy products to women who do not found that the concentration of IGF-1 in the blood of women who consumed dairy was 13 percent higher than in vegan women. It also found that women who ate dairy products

5

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

were five times more likely than vegan women to have had twins.72 The author of the study, Dr. Gary Steinman, noted that throughout the 1990s, the rate of human twinning increased beyond what the scientific community expected. “The continuing increase in the twinning rate ... [may] be a consequence of the introduction of growth-hormone treatment of cows to enhance their milk and beef production,” he speculated.73

Why rBGH? Growth Hormones and the Push to “Get Big or Get Out” RBGH didn’t become popular simply because dairy farmers felt like trying something new. Despite all of the health problems that result for cows treated with rBGH, the artificial hormone does generally increase the amount of milk that cows produce, typically by 11-15.6 percent.74 Dairy producers have been under tremendous pressure to “get big or get out” — in other words, to scale up their production or exit the industry — and rBGH was aggressively marketed to them as a scaling-up tool. To fully understand why farmers moved to rBGH, it’s helpful to look at general trends that have shaped the dairy industry over the last 25 years. During this period, the number of dairies in operation in the United States fell sharply. In 1993, the year that rBGH first came on the market, the United States was home to 157,000 dairies. Today we have just over 71,000, a decline of 55 percent.75 The number of dairy cows has fallen less rapidly during this time, from 9.5 million to 9.1 million head, a testament to the fact that remaining dairies are much larger on average than they were

Change in U.S. Milk Prices and Production, 1970-2006

in the early 1990s. Back then, a typical large dairy housed 500 cows; today, several thousand is the norm.76 Despite the falling number of dairies and cows, the amount of milk produced in the United States has increased since 1993, from 150 million gallons to 170 million.77 Not all of that increase can be attributed to rBGH, but some presumably can, given the role it plays in boosting cows’ milk production. In 2007, nearly 43 percent of large-scale dairies (over 500 head), 30 percent of mid-sized dairies, and 9 percent of small dairies used rBGH on their cows.78 Dairy producers have been under pressure to increase their production because dairy prices have been quite volatile since the early 1980s, at times dropping so low that producers are unable to cover their production costs.79 During periods of low prices, dairy farmers tend not to reduce their production; after all, they cannot simply turn off their cows, and selling off such an expensive investment is not something farmers do lightly. Instead, they try to maximize production in order to spread their costs across as much output as possible. That may sound confusing at first, but try applying the concept to a different scenario. Say that you own a copy store and the going rate for copies falls from 25 cents to 20 cents per copy. Your first response won’t be to immediately sell off all of your copy machines; instead, to avoid losing customers, you’ll accept the lower price. At the same time, you still have all those copy machines to pay off, so you’ll try

6

Food & Water Watch

to increase the number of copies that you sell each day in order to make up for the price decline. In other words, you will increase the number of units sold to make up for the lower price you receive for each unit. This is the same situation in which dairy producers find themselves when prices fall, and they tend to respond the same way – by increasing the volume of milk they sell to make up for the lower price (see graph above). And in the mid-1990s, when producers heard about Posilac, some saw the drug as a way to do that. Unfortunately, rBGH was no panacea. When they begin using it, dairy producers take on the added cost of buying the drug and treating their cows for the diseases associated with it, including mastitis, reproductive problems, and lameness. Meanwhile, actions by commodity speculators impacted the complicated formulas used to set milk prices, 80 and the prices that farmers received fell ever lower. 81 Today, for every dollar that consumers spend on milk, dairy farmers receive only $0.27 — 25 percent less than they received in 1993.82

Labeling When it approved rBGH, FDA found that since it could find no distinguishable difference between the milk that comes from cows treated with rBGH versus those that were not, it could not require any label on milk that was produced using the synthetic growth hormone.83 Given the amount of controversy surrounding rBGH, this decision was surprising, and dairies that weren’t using the artificial hormone quickly began labeling their products as such. However, FDA went even further by making any attempts at labeling the absence of rBGH extremely difficult. According to FDA guidance on rBGH labeling that was signed by Michael Taylor in 1994, the simple phrase “rBGH free” was misleading, and a lengthy qualifying sentence stating FDA’s conclusions should be included on any rBGH related label.84 The disclaimer must state, “No significant difference has been shown between milk derived from rbST-treated and nonrbST-treated cows.”85

labels to appear on milk, claiming that the practice was damaging its business.89 Ben & Jerry’s was one company that made an immediate and significant push to label its products as free of rBGH. The Vermont-based ice cream manufacturer first included an rBGH-free label on its ice cream in February 1994,90 and aggressively defended that decision by continually modifying its label to in order to withstand challenges91 as well as suing the state of Illinois in order to protect its right to label its products.92 Illinois was one of the first states to ban any labeling of an absence of rBGH, and this essentially made it impossible for Ben & Jerry’s to market their products nationwide as not produced with rBGH.93 A serious side effect of state labeling requirements is that dairy companies can find it next to impossible to make one label that can be used in every state. This effectively prevents dairy manufacturers and milk retailers from truthfully labeling their products as rBGH free since it is significantly easier to have no label than to make a different label for each state.94 The company’s settlement with the state of Illinois in 1997 enabled Ben & Jerry’s and other companies to market and label their products nationwide as not produced with rBGH. As a result of the settlement, Ben & Jerry’s products include the disclaimer, “the FDA has said no significant difference has been shown and no test can now distinguish between milk from rBGH treated and untreated cows.”95

Just days after FDA released the document, Monsanto filed suit against two dairy farms that had labeled their milk “rBGH-free.”86 King & Spalding, Taylor’s former law firm, also sent a number of letters to dairy farmers on behalf of Monsanto, using the guidelines Taylor helped draft at FDA to show that the farmers were out of compliance with FDA regulations.87 FDA also got involved and sent warning letters to several dairies that had labeled their milk “hormone free,” stating that they were violating the Food Drug and Cosmetic act for misbranding.88 Monsanto even complained to FDA and the FTC for allowing any rBGH related

7

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

In 2007 and 2008 a number of states, at the urging of groups backed by Monsanto,96 made significant moves to restrict the type of rBGH free labeling that could appear on dairy products. AFACT, a pro-rBGH organization that was created during this time and founded in part by Monsanto, lobbied for the passage of labeling rules in many of these states.97 Some states, such as Utah,98 had proposals that were modeled after FDA guidelines, while others, including Ohio, made more specific requirements in terms of the type, size, and location of FDA’s disclaimer.99 Missouri and Pennsylvania went even further and attempted to ban any mention of an absence of rBGH.100 In Pennsylvania, the agricultural secretary attempted to create an outright ban on any rBGH labeling, but this was reversed due to consumer backlash and reduced to a rule that was similar to the original FDA proposal.101 Missouri’s proposal was met with a similar reaction, and due to consumer protest the original bill had to be modified102 before eventually dying in committee.103 With state legislatures and agriculture departments around the country continuing to grapple with this issue, the fight over labeling rBGH is not over. However, industry support for these bills may begin to change now that Monsanto has sold all of its rBGH operations to Elanco, a division of the drug manufacturer Eli Lilly.104

rBGH Has a New Owner In August 2008, pharmaceutical giant Eli Lilly announced that it was acquiring Monsanto’s rBGH operations for $300 million.105 Posilac (Monsanto’s brand name for rBGH) and its supporting operations became part of Eli Lilly’s Elanco division, which handles animal health and nutrition.106 Elanco was already the exclusive international seller of Posilac in the decade preceding the acquisition.107 Among other things, Elanco sells antibiotics that are used to treat mastitis in dairy cows. 108 Eli Lilly is the pharmaceutical company responsible for Prozac and other psychiatric drugs, as well as the Viagra competitor Cialis and a number of other medications used to treat various conditions, including cancer.109 Lilly reported $18.6 billion in revenue and almost $3 billion in profit in 2007, significantly more than Monsanto’s $11.3 billion in revenue and $2 billion in profit that fiscal year.110 It is easy to understand why Monsanto would sell its rBGH business. The synthetic hormone is banned for commercial sale in Canada and the European Union,111 national retailers and food companies like Kroger and Starbucks refuse to use milk that was produced with rBGH112 and Dean Foods, the largest milk distributer in the United States,113 states that virtually all of its milk is sourced from cows not treated 8

with the artificial hormone.114 Both Yoplait and Dannon also announced they would be dropping rBGH from their products.115 Even Wal-Mart now uses rBGH-free sources for its private label milk.116 In fact, Monsanto’s stock went up 4.63 percent on the day that it became news that it was eliminating rBGH from its portfolio. It was not immediately clear why Eli Lilly decided to acquire the rBGH operations at this point in time, and in fact, Lilly’s stock declined that same day.117 In its quarterly conference call following the acquisition, Lilly touted the decision as part of a strategy to build its global business.118 The company did not elaborate further, but given the supposed benefits of the product and the current push to expand animal agriculture around the world, it is possible that Lilly will market rBGH to developing countries as a tool for increasing domestic milk production. RBGH is currently approved for use in twenty countries,119 including the United States, South Africa, Brazil, Columbia, Honduras, Kenya and Mexico.120 Whether Eli Lilly will be promoting this product ethically, however, remains to be seen, as Eli Lilly has been involved in a number of controversies over its questionable business and marketing practices. On January 15, 2009, Lilly agreed to settle an “off-label” promotion case with the U.S. Justice Department for a record-setting $1.42 billion.121 Off-label refers to the process of using drugs for purposes that have not been approved by FDA.122 While doctors have discretion to prescribe medications for non-approved purposes, it is illegal for drug companies to promote and market the drugs for these uses.123 This was the largest sum for both a corporate whistleblower claim as well as the largest criminal fine ever imposed by the U.S. upon a single company.124 Lilly was facing criminal and civil charges for violating the Food, Drug and Cosmetic Act and was accused of engaging in a multi-year scheme to persuade doctors to prescribe its anti-psychotic drug Zyprexa for use in two groups of patients for whom the drug was particularly risky and not approved, children and the elderly. 125 As part of the settlement, Lilly agreed to plead guilty to one misdemeanor charge of illegally marketing the drug for use in treating the elderly for various symptoms of dementia.126 The company paid a $615 million penalty for the criminal charges and also paid $800 million to stop the civil investigation from proceeding further.127 In addition, Lilly agreed to be monitored for five years by a federal review organization that will assess and report on the company’s practices, policies, and procedures.128 Lilly had already settled claims for improperly marketing Zyprexa prior to this latest agreement. In October of 2008, Lilly paid out $62 million to 33 states for improperly marketing the drug,129 this time setting a record for the largest

Food & Water Watch

sum in a state consumer protection claim.130 The company was accused of the same illegal behavior, which was promoting the drug for uses that were not approved by FDA and urging doctors to prescribe it for those uses.131 In addition, in 2005 Lilly pled guilty to similar charges of illegal off-label promotion of its drug Evista. Evista was only approved for the prevention and treatment of osteoporosis in post-menopausal women. However, Lilly was allegedly promoting the drug as reducing the risk of cardiovascular disease and breast cancer, a use that FDA had specifically rejected. 132 Lilly agreed to pay a $36 million to settle the Evista case with the U.S. government.133 Lilly also happens to market another drug, Gemzar, which is approved by FDA for treating metastatic breast cancer.134 It needs to be questioned whether Lilly knows that cows injected with rBGH show elevated levels of the hormone IGF-1 in their milk, and that this hormone has been linked to increased rates of breast cancer in humans.135 In addition to its illegal off-label marketing campaigns, Eli Lilly has also engaged in other questionable forms

of drug promotion. In 2006, an article appearing in the peer-reviewed New England Journal of Medicine criticized Lilly’s marketing tactics for the drug Xigris, which is used to treat sepsis, otherwise known as blood poisoning. The FDA approved the drug in 2001, although not without some controversy. The approval was based on a single problematic trial of the drug, and half of FDA advisory panel voted to require another confirmation trial before approval.136 When initial Xigris sales were lower than expected, Lilly hired a public relations firm to help boost sales of the drug. 137 During the period that this PR campaign was taking place, issues continued to arise over the safety and effectiveness of the drug, with increasing calls for further testing of the product.138 While not accusing Lilly of illegal activity, the NEJM article did shed light on what it considered to be particularly unethical marketing strategies;139 as a result of Lilly’s actions, the NEJM article called for a system of creating drug-use guidelines that prohibit pharmaceutical companies from funding or influencing these guidelines.140 Lilly has repeatedly engaged in illegal and unethical marketing of its drugs to doctors and has paid millions of dollars in fines and settlements for doing so. The company

9

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

has also used marketing and promotion to increase the sale of drugs suspected of having ill effects. The money lost settling lawsuits does not seem to have deterred Lilly from continuing its behavior; the company appears to have accepted the fines as just another cost of doing business. It would seem then that Eli Lilly is an excellent choice to take over the reins of a such a controversial product as rBGH, as the company has demonstrated a willingness to engage in illegal marketing to sell its products and may very well continue to use unethical tactics to sell rBGH to unsuspecting people around the world.

Community Responses to rBGH The road to a healthier, more humane dairy production system starts with the removal of rBGH from our dairy supply. A 2008 poll showed that more than 90 percent of U.S. consumers want the right to choose rBGH-free products and want them to be labeled.141 RBGH use is falling among U.S. dairies, too: the most recent USDA survey of U.S. dairy production estimated that rBGH was used on 17.2 percent of cows, compared to 22.3 percent five years earlier.142 It is still fairly common among industrial dairies, though; 42.7 percent of large-scale industrial dairies used it in 2007, compared to 9 percent of small operations and 29 percent of midsized dairies.143 Milk consumers around the country have already made huge headway by urging food companies to go rBGHfree. Thanks to their pressure, major companies including Kroger,144 Wal-Mart,145 Hood,146 Dannon,147 Yoplait148 and others have phased out the use of rBGH milk in some or all of their dairy products.

A 2008 poll showed that more than 90 percent of U.S. consumers want the right to choose rBGH-free products and want them to be labeled.

10

A schoolgirl in Philadelphia voices her support for rBGH-free school milk during Food & Water Watch’s “Know Your Milk Day” in March 2009.

If so many companies are no longer accepting rBGH milk, where is the remaining milk going? One possibility is that it is being funneled to U.S. schoolchildren through school food programs, which require that milk be offered with every school lunch. Schools have therefore become another area where pressure from consumers — in this case parents, teachers, and school board members — has turned the tide against rBGH use. Following the release of rBGH on the market and consumer outcry over it, National Geographic Society’s Green Guide reported in 1997 that “numerous parent and teacher associations have passed rBGH-free resolutions, and over 100 school systems across the country buy only rBGH-free milk.”149 The school board of River Valley, Wisconsin was one of the early participants in the campaign and in the early 1990s passed a resolution asking that the district not purchase milk from suppliers who have knowingly accepted milk from farmers using rBGH. Board member and dairy farmer Randy Smith, who introduced the resolution, was quoted in papers saying, “I’ve got a lot of parents in the district that have told me that they don’t want their children to drink rBGH milk. As a dairy farmer, I don’t want to see a decline in consumption because of rBGH.” The resolution passed the school board five to one.150 Unfortunately, many school districts continue to source milk that is not rBGH free. They do so either because they are not aware that they have the option to choose rBGHfree milk or because they fear it would be too expensive; the school lunch program is notoriously underfunded, with most public schools making do with federal funding equivalent to $2.57 per child per meal.151

Food & Water Watch

Take Action You can help get rBGH out of our schools and the dairy supply by taking action in your community: Help make your school district rBGH-free. Some school districts have successfully built rBGH-free milk into their school wellness policies,152 (in 2004, all districts were required to draft a wellness policy that addressed physical activity, nutrition, and other issues) and others have required the dairy companies that contract with them to supply rBGH-free milk. You can prepare a presentation for parent groups or your local school board about the problems with rBGH and ask the school board to adopt an rBGH-free policy. For more resources on how to make your district rBGH-free, see Food & Water Watch’s School Milk Campaign, www.foodandwaterwatch.org/food/ school-milk. Preserve your right to know. Bills have been introduced in several states that would prohibit farmers and dairy processors from labeling their milk as rBGH-free. These bills could keep the market for rBGH milk alive by pulling the wool over consumers’ eyes. Check to see if a labeling bill has been introduced in your state and organize letter-writing and call-in campaigns to your state legislators. Let them know that they should preserve consumers’ right to information about their food and preserve rBGHfree labeling!

In 2006, Food & Water Watch “dairy cows” engaged consumers in Washington, D.C., and elsewhere to ask Starbucks to switch to rBGH-free milk. After hearing the response from their patrons, Starbucks eliminated all rBGH milk from its stores less than two months later. Photo by Brendan Hoffman.

With labeling under attack, it’s more important than ever to send a clear message to dairy companies that consumers want rBGH-free milk and will choose it if it is properly labeled. Tell dairy providers and restaurants to go rBGH free. Past consumer campaigns have successfully turned the tide against rBGH use — but there is still much to be done. With labeling under attack, it’s more important than ever to send a clear message to dairy companies that consumers want rBGH-free milk and will choose it if it is properly labeled. If the dairy products you buy are not labeled rBGH free, then call the dairy company, ask them if their suppliers use the drug, and tell them that you are switching to an rBGH-free brand unless they commit to prohibiting its use. If the company claims their products are already rBGH-free, tell them to label their products so that consumers can make the right choice. For information on dairy products that are already produced without rBGH go to: http://www.foodandwaterwatch.org/take-action/ consumer-tools/milk-tip/rbgh-free-guide. Ask FDA to revoke its approval of rBGH. The research that has been done since FDA approved rBGH in 1993 has raised enough concerns that Canada and the European Union refused to approve the drug in 1998 and 1999.153 The FDA’s approval process was nontransparent and relied heavily on confidential industry-funded studies. While we still have much to learn about how rBGH impacts human health, the evidence is clear enough: We should not be risking public health by continuing to allow rBGH use. The FDA should revoke rBGH approval and appoint an unbiased panel of scientists to carry out a thorough, public review of existing research. Tell your members of Congress that you are concerned about rBGH in the dairy supply. They should bring attention to the issue through hearings and should follow the lead of Canada and the EU by instructing FDA to revoke its approval of rBGH.

11

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

Endnotes 1

Collier, Robert. “Regulation of rbST in the US.” AgBioForum, vol 3 no. 2 & 3. 2000 at 156-163. 2 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association expert panel on rBST.” Available at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_ cvma-rap_acdv_tc-tm-eng.php. November 1998, section 7; Groves, Martha. “Canada Rejects Hormone that Boosts Cows’ Milk Output.” Los Angeles Times. January 15, 1999; European Commission, Directorate General for Health and Consumer Protection. “Report on Public Health Aspects of the Use of Bovine Somatotrophin.” Available at http://ec.europa.eu/food/fs/sc/scv/out19_en.html. March 1999. 3 “Monsanto’s BST barely beat tomato to market.” The Chicago SunTimes. March 20, 1994 at 28. 4 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994, at 6. 5 “Cow Hormone no threat to humans, panel says.” The Chicago Tribune. April 1, 1993 at 4. 6 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 6. 7 U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992 at 2. 8 Feder, Barnaby. “In battling for biotech, Monsanto is the leader.” The New York Times. December 24, 1993 at D1. 9 Sinclair, Ward. “Independent Study Urged Of Bovine Growth Hormone; Adequacy of Marketing Research Challenged.” The Washington Post. September 17, 1987 at A12. 10 Gibbons, Ann. “FDA publishes bovine growth hormone data.” Science Magazine. August 24, 1990 at 852. 11 Gibbons, Ann. “FDA publishes bovine growth hormone data.” Science Magazine. August 24, 1990 at 852. 12 “FDA panel told bovine growth hormone safe.” United Press International. March 31, 1993. 13 Kusserow, Richard P. “Audit of issues related to the Food and Drug Administration review of bovine somatotropin.” Office of the Inspector General. (A-15-90-00046). February 21, 1992 at 6.

12

14 Kusserow, Richard P. “Audit of issues related to the Food and Drug Administration review of bovine somatotropin.” Office of the Inspector General. (A-15-90-00046). February 21, 1992 at 6. 15 Kusserow, Richard P. “Audit of issues related to the Food and Drug Administration review of bovine somatotropin.” Office of the Inspector General. (A-15-90-00046). February 21, 1992 at 6. 16 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the whistle.” Business Week. September 2, 1991 at 75; Schneider, Keith. “F.D.A. accused of improper ties in review of drug for milk cows.” The New York Times. January 12, 1990 at A21. 17 Schneider, Keith. “F.D.A. accused of improper ties in review of drug for milk cows.” The New York Times. January 12, 1990 at A21. 18 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the whistle.” Business Week. September 2, 1991 at 75. Schneider, Keith. “F.D.A. accused of improper ties in review of drug for milk cows.” The New York Times. January 12, 1990 at A21. 19 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the whistle.” Business Week. September 2, 1991 at 75. 20 Schneider, Keith. “F.D.A. accused of improper ties in review of drug for milk cows.” The New York Times. January 12, 1990 at A21. 21 See U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992 at 6. 22 See U.S. General Accounting Office. “FDA strategy needed to address animal drug residues in milk.” (B-246269). August 5, 1992. 23 U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992 at 6. 24 Cruzan, Susan. U.S. Department of Health and Human Services, U.S. Food and Drug Administration. “FDA Response to GAO report on review of bST.” August 17, 1992. 25 U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992 at 8 and 29. 26 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 1. 27 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 18.

Food & Water Watch

28 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 19. 29 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 19. 30 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 6, 18-19. 31 See U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 21-22. 32 “Interim guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin.” 59 Fed. Reg. 6279, (February 10, 1994). 33 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 23-24. 34 Gladwell, Malcolm. “Biotech food products won’t require special rules, FDA decides.” The Washington Post. May 26, 1992 at A4. 35 Lambrecht, Bill. “New biotech crops need watchdogs, report warns.” St. Louis Post-Dispatch. April 25, 2003 at A9. 36 Sarasohn, Judy. “Special interest; Monsanto losing VIP.” The Washington Post. December 23, 1999 at A19. 37 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 8. 38 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 8. 39 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 8. 40 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 8-9. 41 See U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 10-11, 12, 13. 42 See U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 16-17. 43 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 16-17. 44 U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 17. 45 See U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 17-18. 46 See U.S. General Accounting Office. “Comments on FDA employees alleged conflicts of interest in drug approval.” (B-257122). October 19, 1994 at 18. 47 United States Food and Drug Administration, Freedom of Information summary for Posilac®, Package Insert, November 1993. 48 United States Food and Drug Administration, Freedom of Information summary for Posilac®, Package Insert, November 1993. 49 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association Expert Panel on rBST.” Available at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/ rep_cvma-rap_acdv_exec-somm-eng.php. November 1998. 50 European Commission, Directorate General of Health and Consumer Protection. “Report on Animal Welfare Aspects of the Use of Bovine Somatotrophin.” March 10, 1999 at 58. 51 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association Expert Panel on rBST.” Available at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_cvma-rap_acdv_exec-somm-eng.php. November 1998, at Section 11.

52 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association Expert Panel on rBST.” Available at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/ rep_cvma-rap_acdv_exec-somm-eng.php. November 1998; Groves, Martha. “Canada Rejects Hormone that Boosts Cows’ Milk Output.” Los Angeles Times, January 15, 1999; European Commission, Directorate General of Health and Consumer Protection. “Report on Animal Health and Animal Welfare on Aspects of the Use of Bovine Somatotropin.” March 1999 at 76. 53 United States Food and Drug Administration. “Freedom of Information summary for Posilac®.” November 1993. 54 Smith, David, Harris, Anthony, Johnson, Judith, Silbergeld, Ellen, and Morris, Glenn. “Animal antibiotic use has an early but important impact on the emergence of antibiotic resistance in human commensal bacteria.” Proceedings of the National Academies of Science – USA. Vol. 99, 2002 at 6434-9. 55 Hoben, D., Burvenich, C., and Heyneman, R. “Antibiotics Commonly Used to Treat Mastitis and Respiratory Burst of Bovine Polymorphonuclear Leukocytes.” Journal of Dairy Science. Vol. 81, no. 2, 1998 at 403-410. 56 U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992, at 6. 57 Smith, David, Harris, Anthony, Johnson, Judith, Silbergeld, Ellen, and Morris, Glenn. “Animal antibiotic use has an early but important impact on the emergence of antibiotic resistance in human commensal bacteria.” Proceedings of the National Academies of Science — USA. Vol. 99, 2002 at 6434-9. 58 Kumar, Kuldip, Gupta, Satish, Chander, Yogesh, and Singh, Ashok. “Antibiotic Use in Agriculture and its Impact on the Terrestrial Environment.” Adv Agro. Vol. 87, 2005 at 1-54. 59 Graham, Jay, Price, Lance, Evans, Sean, Graczyka, Thaddeus, and Silbergeld, Ellen. “Antibiotic-resistant enterococci and staphylococci isolated from flies collected near confined poultry feeding operations.” Sci Total Env. Article in press, 2009. 60 White, David, Zhao, Shaohua, Sudler, Robert, Ayers, Sherry, Friedman, Sharon, Chen, Sheng, McDermott, Patrick, McDermott, Shawn, Wagner, David, and Meng, Jianghong. “The isolation of antibiotic-resistant Salmonella from retail ground meats.” N Engl J Med. Vol. 345, 2001 at 1147-1154; Consumer Reports. “Dirty Birds.” In Consumer Reports, available at http://www.consumerreports. org/cro/food/food-safety/chicken-safety/chicken-safety-1-07/ overview/0107_chick_ov.htm. Accessed March 4 2009; published January 2007; de Boera, E, Zwartkruis-Nahuisa, JTM, Wita, B., Huijsdensc, XW, de Neelingc, AJ, Boschc, T., van Oosteromb, RAA, Vilaa, A., and Heuvelinka, AE. “Prevalence of methicillin-resistant Staphylococcus aureus in meat.” Int J Food Microbiology. Article in Press, 2009. 61 Centers for Disease Control and Prevention. “Get Smart: Know When Antibiotics Work.” Available at http://www.cdc.gov/ drugresistance/community/campaign-info.htm. Accessed February 4, 2009. 62 McEwen, Scott, Black, William, and Meek, Alan. “Antibiotic Residues (bacterial inhibitory substances) in the milk of cows treated under label and extra-label conditions.” Can Vet J. Vol. 33 no. 8, August 1992, at 527-534. 63 U.S General Accounting Office. “FDA Strategy Needed to Address Animal Drug Residues in Milk.” Report to the House Human Resources and Intergovernmental Relations Subcommittee, Committee on Government Operations. August 1992 at 2. 64 U.S. General Accounting Office. “Recombinant bovine growth hormone: FDA approval should be withheld until the mastitis issue is resolved.” (B-248450). August 6, 1992 at 6. 65 Mellon, Margaret, Benbrook, Charles, and Benbrook, Karen. “Hogging It: Estimates of Antimicrobial Abuse in Livestock.” Union of Concerned Scientists. January 2001. 66 European Commission. “Report on Public Health Aspects of the Use of Bovine Somatotrophin. Food Safety — From the Farm to the Fork.” March 15-16, 1999.

13

rBGH: How Artificial Hormones Damage the Dairy Industry and Endanger Public Health

67 European Commission. “Report on Public Health Aspects of the Use of Bovine Somatotrophin. Food Safety — From the Farm to the Fork.” March 15-16, 1999. 68 European Commission. “Report on Public Health Aspects of the Use of Bovine Somatotropin. Food Safety — From Farm to the Fork.” March 15-16, 1999. 69 Kimura, Toshikiro, Murakawa, Yusuke, Ohno, Misako, Ohtani, Seiji, and Higaki, Kazutaka. “Gastrointestinal absorption of recombinant human insulin-like growth factor-1 in rats.” Journal of Pharmacology and Experimental Therapeutics. Vol. 283, no. 2, July 1997 at 611-618; Anderle, Pascale, Langguth, Peter, Rubas, Werner, and Merkle, Hans. “In Vitro Assessment of Intestinal IGF-1 Stability.” Journal of Pharmaceutical Sciences, Vol, 91 no. 1, January 2002, at 290-300; Hansen, Michael, Ph.D, et al. “Potential Public Health Impacts Of The Use Of Recombinant Bovine Somatotropin In Dairy Production.” Consumers Union. September 1997. 70 Yu H and Rohan T. “Role of the Insulin-Like Growth Factor Family in Cancer Development and Progression.” Journal of the National Cancer Institute, Vol. 92, no 18, September 20, 2000, at 1472-1489; Moschos S and Mantzoros C. “The Role of the IGF System in Cancer: From Basic to Clinical Studies and Clinical Applications.” Oncology. Vol. 63, no. 4, November 4, 2002, at 317-332. 71 American Nurses Association House of Delegates. “Resolution: Healthy Food in Health Care.” 2008. Available at http://www.nursingworld.org/MainMenuCategories/ OccupationalandEnvironmental/environmentalhealth/PolicyIssues/ HealthyFoodinHealthCare.aspx. Accessed April 10, 2009. 72 Steinman, Gary. “Mechanisms of twinning. VII. Effect of diet and heredity on the human twinning rate.” Journal of Reproductive Medicine. Vol. 51, no. 5, 2006 at 405-410. 73 North Shore-Long Island Jewish Health System. “Press release: Study by LIJ Obstetrician finds that a woman’s chances of having twins can be modified by diet.” Available at http://www.nslij.com/template.cfm ?xyzpdqabc=0&id=204&action=detail&ref=808. June 7, 2006. 74 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association Expert Panel on rBST.” November 1998, at Section 4. 75 US Department of Agriculture, National Agricultural Statistics Service. “National data: Farms, number of cows, milk per cow.” Accessible at http://www.nass.usda.gov/Data_and_Statistics/ Quick_Stats/index.asp#top. Accessed April 5, 2009. 76 US Department of Agriculture, National Agricultural Statistics Service. “National data: Farms, number of cows, milk per cow.” Accessible at http://www.nass.usda.gov/Data_and_Statistics/ Quick_Stats/index.asp#top. Accessed March 10, 2009. 77 US Department of Agriculture, National Agricultural Statistics Service. “Quick Stats.” Available at www.nass.usda.gov/Data_and_ Statistics/Quick_Stats/index.asp#top; accessed March 10, 2009. 78 United States Department of Agriculture. “Dairy 2007.” October 2007 at 79. 79 U.S. Department of Agriculture, Economic Research Service. “Current and historic milk costs and returns.” Available at http://ers.usda.gov/ Data/CostsAndReturns/testpick.htm. Accessed March 19 2009. 80 Bunting, John. “Dairy Farm Crisis 2009: A Look Beyond the Conventional Analysis.” Available at www.nffc.net/Pressroom/Press percent20Releases/2009/Bunting percent20- percent20Dairy percent20Farm percent20Crisis percent202009.pdf. Accessed March 5, 2009. 81 US Department of Agriculture, Economic Research Service. “Price Spreads from Farm to Consumer: At-Home Foods by Price Group (Dairy).” Available at http://www.ers.usda.gov/Data/ FarmToConsumer/pricespreads.htm. Accessed August 7, 2008. 82 US Department of Agriculture, Economic Research Service. “Price Spreads from Farm to Consumer: At-Home Foods by Price Group (Dairy).” Available online at http://www.ers.usda.gov/Data/ FarmToConsumer/pricespreads.htm. Accessed August 7, 2008. 83 “Interim guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin.” 59 Fed. Reg. 6279, (February 10, 1994).

14

84 “Interim guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin.” 59 Fed. Reg. 6279, (February 10, 1994). 85 “Interim guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin.” 59 Fed. Reg. 6279, (February 10, 1994). 86 Rosenfeld, Steven P. “Dairy cooperative says it will fight Monsanto suit.” The Associate Press. February 21, 1994. 87 Puzo, Daniel P. “Conflict of interest alleged in BGH approval.” The Los Angeles Times. April 21, 1994 at H2. 88 U.S Food and Drug Administration. [Press release]. “FDA Warns Milk Producers to remove ‘hormone free’ claims from the labeling of dairy products.” September 12, 2003. 89 Hedges, Stephen J. “Monsanto having a cow in milk label dispute.” Chicago Tribune. April 15, 2007 at C1. 90 McCarthy, Colman. “Monsanto’s cash cow trips milk alarm.” The Washington Post. March 1, 1994 at D20. 91 Gilgoff, Henry. “Dairy labels go sour; it’s hard to milk antihormone sentiment.” New York Newsday. March 24, 1994 at A49. 92 Wu, Olivia. “Dairy companies sue Illinois to allow change in labels.” Chicago Sun-Times. May 8, 1996 at A14; Berselli, Beth. “Settlement reached in hormone labeling case; Ben and Jerry’s, states agree food makers can indicate absence of added product.” The Washington Post. August 15, 1997 at A22. 93 Berselli, Beth. “Settlement reached in hormone labeling case; Ben and Jerry’s, states agree food makers can indicate absence of added product.” The Washington Post. August 15, 1997 at A22. 94 “Ben and Jerry’s, state in accord on growth hormone statement.” The Chicago Tribune. August 14, 1997 at BU4; Berselli, Beth. “Settlement reached in hormone labeling case; Ben and Jerry’s, states agree food makers can indicate absence of added product.” The Washington Post. August 15, 1997 at A22. 95 Berselli, Beth. “Settlement reached in hormone labeling case; Ben and Jerry’s, states agree food makers can indicate absence of added product.” The Washington Post. August 15, 1997 at A22. 96 Melcer, Rachel. “Lawmakers consider bill to restrict labels on milk containers.” St. Louis Post-Dispatch. April 17, 2008 at B1. 97 Martin, Andrew. “Fighting on a battlefield the size of a milk label.” The New York Times. March 9, 2008, at BU7. 98 “Utah proposes rules on milk labels.” The Associated Press State & Local Wire. February 28, 2008. 99 Lewis, Zachary. “State eases label rule for hormone in cows.” Cleveland Plain Dealer. March 27, 2008 at C1. 100 Melcer, Rachel. “Lawmakers consider bill to restrict labels on milk containers.” St. Louis Post-Dispatch. April 17, 2008 at B1; Avril, Tom. “Hormone labeling of Pa. milk to end.” The Philadelphia Inquirer. December 23, 2007 at A01. 101 Malloy, Daniel. “State reverses on dairy labeling, allows hormone claims.” Pittsburgh Post-Gazette. January 18, 2008 at A1. 102 Melcer, Rachel. “Lawmakers consider bill to restrict labels on milk containers.” St. Louis Post-Dispatch. April 17, 2008 at B1. 103 Actions on Missiouri SB 1279. Available at: http://www.senate. mo.gov/08info/BTS_Web/Actions.aspx?SessionType=R&BillID=15 4026. Accessed 04/01/09. 104 Clapp, Stephen. “Kansas is latest battleground in “rBST-free” labeling fight.” Food Chemical News. December 22, 2008 at pg 5; Eli Lilly. [Press release]. “Elanco Announces Acquisition of Posilac(R) Dairy Business.” August 29, 2008. 105 Eli Lilly. [Press release]. “Elanco Announces Acquisition of Posilac(R) Dairy Business.” August 29, 2008. 106 Eli Lilly. [Press release]. “Elanco Announces Acquisition of Posilac(R) Dairy Business.” August 29, 2008. 107 Eli Lilly. [Press release]. “Elanco Announces Acquisition of Posilac(R) Dairy Business.” August 29, 2008. 108 Elanco - Veterinary. Elanco Australia. Available at http://www. elanco.com.au/veterinary/index.html. Accessed 05/05/09. 109 Eli Lilly & Company >> Products. Available at: http://www.lilly. com/products/. Accessed 05/05/09.

Food & Water Watch

110 Monsanto. Securities and Exchange Commission. 10-K filing. October 24, 2008 at 49; Securities and Exchange Commission. 10-K filing. October 21, 2008 at 18. 111 Yousfi, Jennifer. “Monsanto sells off controversial milk-hormone to focus on seed product lines.” Money Morning. August 23, 2008. 112 Yousfi, Jennifer. “Monsanto sells off controversial milk-hormone to focus on seed product lines.” Money Morning. August 23, 2008. 113 Dean Foods. Securities and Exchange Commission. 10-K Filing. February 24, 2009 at 1. 114 Dean Foods. 2008 Corporate Responsibility Report at 12. 115 General Mills. [Press release]. “General Mills Announces Commitment to Make Yoplait Yogurt Products 100 Percent Free of Milk from Cows Treated with rBST by August 2009.” February 2, 2009; Heller, Lorraine. “Dannon removes growth hormone from dairy products.” Dairyreporter.com. February 23, 2009. 116 Wal-Mart. [Press release]. “Wal-Mart Offers Private Label Milk Produced without Artificial Growth Hormone.” March 21, 2008. 117 Yousfi, Jennifer. “Monsanto sells off controversial milk-hormone to focus on seed product lines.” Money Morning. August 23, 2008. 118 Eli Lilly & Co. Q3 FY08 Earnings Call. October 23, 2008. 119 Martin, Andrew and Pollack, Andrew. “Monsanto to sell off hormone business.” New York Times. Section C1. August 7, 2008. 120 Raine, George. “Got rBST in your milk?; Dairy co-op bows to pressure to stop use of hormone.” San Francisco Chronicle. Pg D1. March 25, 2008. 121 Harris, Gardner. “Lilly Said to Be Near $1.4 Billion Settlement on Drug.” New York Times. Jan. 14, 2009. 122 “Eli Lilly fined nearly $1.5B in drug marketing case.” CNNMoney. com. January 15, 2009. 123 Harris, Gardner. “Lilly Said to Be Near $1.4 Billion Settlement on Drug.” New York Times. Jan. 14, 2009. 124 Fisk, Margaret Cronin et al. “Lilly to pay biggest fine ever to end Zyprexa Probe.” Bloomberg News. Jan. 15, 2009. 125 Harris, Gardner. “Lilly Said to Be Near $1.4 Billion Settlement on Drug.” New York Times. Jan. 14, 2009. 126 Loftus, Peter. “Lilly to pay $1.42 billion to settle Zyprexa charges.” Dow Jones Newswires. January 15, 2009. 127 Fisk, Margaret Cronin et al. “Lilly to pay biggest fine ever to end Zyprexa Probe.” Bloomberg News. Jan. 15, 2009. 128 Fisk, Margaret Cronin et al. “Lilly to pay biggest fine ever to end Zyprexa Probe.” Bloomberg News. Jan. 15, 2009. 129 Berenson, Alex. “33 states to get $62 million in Zyprexa case settlement.” New York Times. Oct. 6, 2008. 130 Berenson, Alex. “33 states to get $62 million in Zyprexa case settlement.” New York Times. Oct. 6, 2008. 131 Berenson, Alex. “33 states to get $62 million in Zyprexa case settlement.” New York Times. Oct. 6, 2008. 132 U.S. Department of Justice. [Press release]. “Eli Lilly and company to pay U.S. $36 million relating to off-label promotion.” Dec. 21, 2005. Although in 2007, FDA did approve the use of Evista to reduce the risk of breast cancer in post-menopausal women. See “FDA Approves New Uses for Evista.” FDA News. September 14, 2007. 133 U.S. Department of Justice. [Press release]. “Eli Lilly and company to pay U.S. $36 million relating to off-label promotion.” Dec. 21, 2005. 134 Gemzar.com - Home. Available at http://www.gemzar.com. Accessed 05/05/09. 135 Hansen, Michael, Ph.D, et al. “Potential Public Health Impacts Of The Use Of Recombinant Bovine Somatotropin In Dairy Production.” Consumers Union. September 1997. 136 Eichacker, Peter Q., M.D. et al. “Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly.” New England Journal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1640. 137 Eichacker, Peter Q., M.D. et al. “Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly.” New England Journal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1640. 138 Eichacker, Peter Q., M.D. et al. “Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly.” New England Journal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1642.

139 Eichacker, Peter Q., M.D. et al. “Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly.” New England Journal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1642. 140 Eichacker, Peter Q., M.D. et al. “Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly.” New England Journal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1642. 141 Consumer Reports National Research Center, 2008, Food Labeling Poll 2008, November 2008. 142 USDA Animal and Plant Health Inspection Service. “Info Sheet: Bovine Somatotropin.” May 2003. 143 United States Department of Agriculture. “Dairy 2007.” October 2007 at 79. 144 Kroger Co. [Press release]. “Kroger to Complete Transition to Certified rBST-Free Milk by Early 2008.” August 1 2007. 145 Lentini, Nina. “Wal-Mart’s Milk Now Comes from Non-rBST Cows.” Marketing Daily. March 24 2008. 146 “Newsline: Dean, Hood Going no-rBST.” Dairyfoods.com. October 1, 2006. 147 Heller, Lorraine. “Dannon removes growth hormone from dairy products.” Dairyreporter.com. February 23, 2009. 148 General Mills. [Press release]. “General Mills Announces Commitment to Make Yoplait Yogurt Products 100 Percent Free of Milk from Cows Treated with rBST by August 2009.” February 2, 2009. 149 Baxter, Carol. “Reading, ‘riting and rBGH: What Kind of Milk is Being Served in Your Child’s School?” National Geographic Green Guide No. 36. Available online at http://www.thegreenguide.com/doc/36/ milk . March, 1997. 150 Bio/Technology/Diversity News Bulletin. “School Districts say No to BGH.” Vol. 2, No. 21, December 1993; Food & Water Watch staff interview with John Kinsman, Wisconsin dairy farmer (September 10 2008). 151 Food Research and Action Center. “Federal Food Programs — National School Lunch Program.” Available at http://www.frac.org/html/federal_food_programs/programs/nslp.html. Accessed March 31, 2009. 152 See, for example, the San Francisco Unified School District Wellness policy, available at http://www.sfusdfood.org/; see also the Berkeley Unified School District Wellness Policy, available at http://www. chefann.com/html/tools-links/BUSD/BUSD-documents/BUSDWellness-Policy.pdf. 153 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Health Canada, Drug and Health Products. “Report of the Canadian Veterinary Medical Association expert panel on rBST.” Available at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/ rep_cvma-rap_acdv_tc-tm-eng.php. November 1998, at Section 7; Groves, Martha. “Canada Rejects Hormone that Boosts Cows’ Milk Output.” Los Angeles Times, January 15 1999; European Commission, Directorate General for Health and Consumer Protection. “Report on Public Health Aspects of the Use of Bovine Somatotrophin.” Available at http://ec.europa.eu/food/fs/sc/scv/ out19_en.html. March 1999.

15

Food & Water Watch Main office: 1616 P St. NW, Suite 300 Washington, DC 20036 tel: (202) 683-2500 fax: (202) 683-2501 [email protected] www.foodandwaterwatch.org

California office: 25 Stillman Street, Suite 200 San Francisco, CA 94107 tel: (415) 293-9900 fax: (415) 293-9908 [email protected]