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

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rBGHHow Artificial Hormones

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About Food & Water WatchFood & Water Watch is a nonprofit consumer organization that works to ensure clean water and safe food. We challengethe corporate control and abuse of our food and water resources by empowering people to take action and by transformingthe public consciousness about what we eat and drink. Food & Water Watch works with grassroots organizations aroundthe world to create an economically and environmentally viable future. Through research, public and policymaker educa-tion, media and lobbying, we advocate policies that guarantee safe, wholesome food produced in a humane and sustainablemanner, and public, rather than private, control of water resources including oceans, rivers and groundwater.

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

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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........................................................................................................................................

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

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................................................................................................................................................................................1

Endnotes..........................................................................................................................................................12

rBGH 101How Artificial Hormones Damage the Dairy Industry

and Endanger Public Health


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Injecting otherwise healthy cows

with genetically engineered growth

hormones is, in my view, unnatural,unnecessary and unfair to dairycows. Consumers should be ableto decide for themselves whether ornot they buy milk from rBGH-treatedcows. We believe if they had theinformation to make the choice, they

will not. A representative of Ben and Jerrys

Homemade, Inc., on filing a lawsuit in 1996to label their products rBGH-free


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Consumer pressure on dairy companies to abandon theuse of this controversial drug has resulted in an increas-ing number of companies moving to rBGH-free milk andmaking sure that consumers know theyve made the change

by labeling their products as such. But across the country,legislators and state regulators are responding to industrypressure by trying to ban rBGH-free labels on dairy prod-ucts. After years of successful campaigns that educateddairy consumers about the risks of rBGH, banned rBGHmilk in some school districts, and pressured major nationalcompanies to go rBGH-free, we are at risk of losing theright 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 byscientific research, the influence of Monsanto, and informa-tion on drug giant Eli Lilly, the new owner of rBGH. Welltell the stories of successful community, state, and nationalcampaigns to kick the dairy industry off the rBGH wagon.

And well finish up with suggestions for action that will helpreaders become advocates for improving the health andsafety of the dairy supply.

Introduction

Recombinant bovine growth hormone (rBGH), also called recombinant bovinesomatotropin (rBST), is a drug that is injected into cows to increase their milkproduction. Developed by the agricultural company Monsanto and approved for com-

mercial 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 thedairy industry.1 RBGH has never been approved for commercial use in Canada or theEuropean Union due to concerns about the drugs impact on animal health.2 The artifi-cial hormones known side effects include increased udder infections and reproductiveproblems in cows. Notably, a growing body of scientific research also suggests a linkbetween drinking rBGH-treated milk and certain types of cancer in humans.


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used to treat mastitis could potentially lead to even greaterlevels of antibiotic residue in milk.23 The FDA, however,disagreed and reaffirmed its initial conclusion that the arti-ficial hormone was safe.24

Unfortunately, consumer, farm and animal welfare groupscould not directly critique the studies submitted to FDA

by the four companies and reviewed by the GAO. In FDAdrug approvals, company studies are generally consideredproprietary business information and are therefore confi-dential. It is therefore impossible for the public to know

which studies and what data FDA bases its decisions onuntil after the decision is made, and even then, the specificdata generally remain confidential. While the GAO reportcriticizing FDAs approval process had access to the FDAstudies, it could not present the specific data to the publicin order to back up its assertion that there were indirect hu-man health impacts from increased mastitis in cows treated

with rBGH.25

Conflicts of interest?FDAs analysis of the human health impact of rBGH wasnot the only cause for alarm during the review process.Three FDA employees working on the synthetic hormoneapplication appeared to have such close ties with rBGH

manufacturer Monsanto that at the request of Represen-tatives George Brown from California, David Obey from

Wisconsin and Bernie Sanders from Vermont, the GAOinvestigated them for conflicts of interest.26

Michael Taylor, the first target of the GAO probe, startedhis career in 1976 as an attorney with FDA before leavingin 1981 to join the law firm of King & Spalding.27 While atKing & Spalding, one of Taylors clients was Monsanto,28and Taylor drafted a memo for Monsanto on whether it

would be constitutional for states to adopt different rulesregarding the labeling of rBGH.29 Taylor left King & Spald-ing in 1991 to join FDA as the Deputy Commissioner ofPolicy,30 where he helped draft FDAs guidance on labelingof rBGH31 that helped prevent dairies from labeling theirproducts rBGH free (see Labeling on page 7).32

Despite the fact the Taylor worked on rBGH labeling is-sues at Monsanto and again at the FDA, the GAO did notconsider this to be a conflict of interest. Since the GAOfelt that the guidance was not a binding agency decision,it was thus not covered by the impartiality standards andtherefore completely excluded from GAO analysis.33 Taylor

who was also responsible for FDAs earlier guidance statingthat there was no need to label genetically modified foods,34

eventually left government service in 199835

for a positionas vice president for public policy at Monsanto.36

The GAO also investigated Margaret Miller, a former em-ployee of Monsanto. While at Monsanto, she was respon-sible for putting together animal safety studies on rBGH.37She left Monsanto in 1989 and immediately went to workfor FDA. 38 In 1991 she was promoted to director of the division of toxicology and environmental sciences, the divisionthat was directly involved in the technical review of rBGH,39

and she later became chief of a branch that was responsiblefor reviewing the human health impacts of rBGH.40 Ac-cording to the GAO, she did not technically violate any con-

flict of interest rules, despite the fact that she did performsome work related to rBGH.41

The third FDA employee that the GAO investigated was Dr.Suzanne Sechen, who worked on Monsanto-funded rBGHstudies while in graduate school at Cornell before leavingin 1988 to join FDA as an animal scientist and the primaryreviewer of rBGH.42 Sechens faculty advisor at Cornell per-formed consulting for Monsanto, and the research Sechenperformed was conducted pursuant to an agreement be-


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tween her advisor and Monsanto.43 Monsanto also providedsupport for several rBGH studies to be performed at Cornell,and some of these were submitted with the rBGH applica-tion as pivotal studies.44 During Sechens time at FDA, sheperformed a considerable amount of work on rBGH, includ-ing publishing articles on the drug in outside journals basedon her former research, and then evaluating several of thosesame articles in her official capacity as a reviewer of theartificial hormone application.45 Yet the GAO found that shedid 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 GAOfailed to address a relevant question in its report: why didFDA approve Monsantos version of the rBGH drug over theother three manufacturers? Given that three FDA officials

with former ties to Monsanto were the subjects of the inves-tigation, the exclusion of this area of inquiry from the GAOreport is curious. Unfortunately, this sheds no light on whyFDA picked Monsanto over the other applicants.

What the Science Tells Us Now:Post-Approval Studies on rBGH

Since FDAs approval of rBGH in 1993, additional researchhas raised further questions about the wisdom of the

agencys decision. The animal welfare problems found inpre-approval studies remain a major concern. The scien-tific community also understands more now about impactsbeyond the barn how treating dairy cows with a syn-thetic growth hormone might impact human health. Somestudies suggest that rBGH use puts human health directlyat risk by altering hormone levels in the humans that con-sume the cows milk, and that it indirectly impacts humanhealth by driving the emergence and spread of antibiotic-resistant strains of bacteria.

Animal welfare

Following the uproar over its decision to approve Posilacfor commercial use, FDA required Monsanto to label itsproduct with a disclaimer listing the many effects that Posi-lac may have on cows. These include reproductive impacts lower birth rates and birth weights of calves as well asphysical ailments such as mastitis and hoof and leg prob-lems.47 A total of 16 different animal health impacts werelisted on the Posilac package insert.48

In the years following rBGHs approval, additional studieshave backed up these findings. The Canadian VeterinaryMedical Association convened an expert panel in 1998 toreview the science on rBGH and found a number of impacts

on cows reproductive performance. The use of rBGH sub-stantially increased the risk that cows would not be able toconceive, but some evidence suggested that it also increasedthe chance that a cow would bear twins or triplets. There

was also evidence of increased risk of cystic ovaries.49 A1999 study published by the European Commissions Sci-entific Committee on Animal Health and Animal Welfarefound that pregnancy rates in rBGH-treated cows fell by

between 7 percent and 27 percent compared to cows nottreated with the synthetic hormone.50

The Canadian veterinary experts found that as a conse-quence of these and other health impacts of rBGH, includ-

ing evidence that treated cows experienced a 50 percentincrease in the risk of lameness compared to cows that

were not treated, rBGH increased the chance that somecows would be culled, or pulled from the herd and slaugh-tered.51 Both Canada and the EU refused to approve thedrug because of outstanding questions related to animal

welfare.52


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Antibiotic resistanceThe increased frequency of mastitis, an udder infection, isone of the main animal welfare impacts of rBGH use andis included in the warning label on Posilac.53 In additionto causing the cows pain, mastitis has a secondary ef-

fect: it requires treatment with antibiotics, and increasedantibiotic use in animal agriculture has been linked to thedevelopment of antibiotic-resistant bacteria that can sickenhumans.54

Many of the antibiotics commonly used to treat mastitisin cows are human-use antibiotics, including drugs fromthe penicillin and erythromycin classes.55 When rBGHincreases the frequency of mastitis in dairy cows, producersmay have to increase their use of antibiotics.56 Antibioticuse in dairy operations exposes bacteria to the antibiotics,contributing to the development of drug-resistant bacte-ria.57 As antibiotic-resistant bacteria spread, they can betransferred to humans through the water or air,58 by flies,59or on the meat that humans consume.60 The U.S. Instituteof Medicine has identified antibiotic resistance as one of thekey threats to health in the United States and the federalCenters for Disease Control and Prevention has identifiedresistance as a top concern.61

Researchers are also concerned about the potential forantibiotic residues to show up in the milk of cows beingtreated with the drugs. Antibiotic residues in milk are asignificant concern when dairy farmers or veterinarians useantibiotics in ways other than that directed on the label,62

a practice that the GAO has called routine.63

Indeed, theFDAs failure to consider the effect rBGH use might have onantibiotic residues in milk was one main reason the GAOrecommended withholding approval.64

It is hard to know what portion of overall antibiotic usetakes place on U.S. farms and ranches because the federalgovernment does not track it, but estimates suggest that asmuch as 70 percent of all antibiotics used for any purposein the United States are fed to animals that are not sick,used as growth promoters or to keep them from becomingill.65 Treatment of cows for mastitis would be in addition tothis number. Anything we can do to reduce the use of anti-

biotics on animals will help reduce the spread of antibiotic-resistant bacteria, including ending the use of rBGH indairy production.

Hormonal effects in humansThere is little evidence that rBGH itself impacts humans

when they drink milk from treated cows, but rBGH doesappear to put human health at risk by increasing the levelsof other chemicals that are linked to human illness. When

dairy cows are treated with rBGH, their bodies increaseproduction of a protein called insulin-like growth factor-1(IGF-1).66 IGF-1 circulates in cows blood and makes its wayinto the animals 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 alsoconsume IGF-1 in the milk of cows not treated with rBGH.However, because rBGH increases the amount of IGF-1 thatcows produce, humans drinking milk from treated cows

will consume more IGF-1 than they otherwise would. Whatcould that mean for human health?

A lot, as it turns out. The early research used by FDA to re-view Posilac suggested that even if humans ingested IGF-1from treated cows milk, the human digestive process woulddestroy it. But more recent research indicates that most

IGF-1 actually survives digestion. IGF-1 binds to casein, themain protein in milk, and may be absorbed into the human

bloodstream along with it.69

Recent research also shows that when present in the humanbody at elevated levels, IGF-1 increases the risk of breast,colon, prostate and other cancers,70 although scientists stilldo not fully understand why. The American Nurses Associ-ation determined that the risk to human health was seriousenough to warrant the passage of a resolution in 2008 call-ing for hospitals and healthcare organizations to eliminatethe purchasing of dairy products from rBGH-treated cowsand to educate nurses on the effects of rBGH.71

Harming human reproduction?It is well known that rBGH impacts cows reproductivesystems, but new research suggests that IGF-1 may also af-fect human reproduction. A 2006 study comparing women

who consume dairy products to women who do not foundthat the concentration of IGF-1 in the blood of women

who consumed dairy was 13 percent higher than in veganwomen. It also found that women who ate dairy products

Recent research shows thatwhen present in the human

body at elevated levels,IGF-1 increases the risk ofbreast, colon, prostate andother cancers.


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were five times more likely than vegan women to have hadtwins.72 The author of the study, Dr. Gary Steinman, notedthat throughout the 1990s, the rate of human twinningincreased beyond what the scientific community expected.The continuing increase in the twinning rate ... [may] be a

consequence of the introduction of growth-hormone treat-ment of cows to enhance their milk and beef production,he speculated.73

Why rBGH? Growth Hormones andthe Push to Get Big or Get Out

RBGH didnt become popular simply because dairy farm-ers felt like trying something new. Despite all of the healthproblems that result for cows treated with rBGH, the arti-ficial hormone does generally increase the amount of milkthat cows produce, typically by 11-15.6 percent.74 Dairy

producers have been under tremendous pressure to get bigor get out in other words, to scale up their production orexit the industry and rBGH was aggressively marketed tothem as a scaling-up tool.

To fully understand why farmers moved to rBGH, its help-ful to look at general trends that have shaped the dairy in-dustry over the last 25 years. During this period, the num-

ber of dairies in operation in the United States fell sharply.In 1993, the year that rBGH first came on the market, theUnited States was home to 157,000 dairies. Today we have

just over 71,000, a decline of 55 percent.75 The number ofdairy cows has fallen less rapidly during this time, from 9.5million to 9.1 million head, a testament to the fact that re-maining dairies are much larger on average than they were

in the early 1990s. Back then, a typical large dairy housed500 cows; today, several thousand is the norm.76

Despite the falling number of dairies and cows, the amountof milk produced in the United States has increased since1993, from 150 million gallons to 170 million.77 Not all ofthat increase can be attributed to rBGH, but some pre-sumably can, given the role it plays in boosting cows milkproduction. In 2007, nearly 43 percent of large-scale dair-ies (over 500 head), 30 percent of mid-sized dairies, and 9percent of small dairies used rBGH on their cows.78

Dairy producers have been under pressure to increase theirproduction because dairy prices have been quite volatilesince the early 1980s, at times dropping so low that pro-ducers are unable to cover their production costs.79 Dur-ing periods of low prices, dairy farmers tend not to reducetheir production; after all, they cannot simply turn off theircows, and selling off such an expensive investment is notsomething farmers do lightly. Instead, they try to maximize

production in order to spread their costs across as muchoutput as possible.

That may sound confusing at first, but try applying the con-cept to a different scenario. Say that you own a copy storeand the going rate for copies falls from 25 cents to 20 centsper copy. Your first response wont be to immediately selloff all of your copy machines; instead, to avoid losing cus-tomers, youll accept the lower price. At the same time, youstill have all those copy machines to pay off, so youll try

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


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to increase the number of copies that you sell each day inorder to make up for the price decline. In other words, you

will increase the number of units sold to make up for thelower price you receive for each unit. This is the same situ-ation in which dairy producers find themselves when prices

fall, and they tend to respond the same way by increasingthe volume of milk they sell to make up for the lower price(see graph above). And in the mid-1990s, when producersheard about Posilac, some saw the drug as a way to do that.

Unfortunately, rBGH was no panacea. When they beginusing it, dairy producers take on the added cost of buyingthe drug and treating their cows for the diseases associ-ated with it, including mastitis, reproductive problems, andlameness. Meanwhile, actions by commodity speculatorsimpacted the complicated formulas used to set milk prices,80 and the prices that farmers received fell ever lower.81Today, for every dollar that consumers spend on milk, dairyfarmers receive only $0.27 25 percent less than theyreceived in 1993.82

Labeling

When it approved rBGH, FDA found that since it could findno distinguishable difference between the milk that comesfrom cows treated with rBGH versus those that were not,it could not require any label on milk that was producedusing the synthetic growth hormone.83 Given the amount ofcontroversy surrounding rBGH, this decision was surpris-ing, and dairies that werent using the artificial hormone

quickly began labeling their products as such. However,FDA went even further by making any attempts at label-ing the absence of rBGH extremely difficult. According toFDA guidance on rBGH labeling that was signed by MichaelTaylor in 1994, the simple phrase rBGH free was mislead-ing, and a lengthy qualifying sentence stating FDAs conclu-sions should be included on any rBGH related label.84 Thedisclaimer must state, No significant difference has beenshown between milk derived from rbST-treated and non-rbST-treated cows.85

Just days after FDA released the document, Monsanto filedsuit against two dairy farms that had labeled their milk

rBGH-free.86 King & Spalding, Taylors former law firm,also sent a number of letters to dairy farmers on behalf ofMonsanto, using the guidelines Taylor helped draft at FDAto show that the farmers were out of compliance with FDAregulations.87 FDA also got involved and sent warning let-ters to several dairies that had labeled their milk hormonefree, stating that they were violating the Food Drug andCosmetic act for misbranding.88 Monsanto even com-plained to FDA and the FTC for allowing any rBGH related

labels to appear on milk, claiming that the practice wasdamaging its business.89

Ben & Jerrys was one company that made an immediateand significant push to label its products as free of rBGH.

The Vermont-based ice cream manufacturer first includedan rBGH-free label on its ice cream in February 1994,90 andaggressively defended that decision by continually modify-ing its label to in order to withstand challenges91 as well assuing the state of Illinois in order to protect its right to labelits products.92 Illinois was one of the first states to ban anylabeling of an absence of rBGH, and this essentially madeit impossible for Ben & Jerrys to market their productsnationwide as not produced with rBGH.93 A serious sideeffect of state labeling requirements is that dairy compa-nies can find it next to impossible to make one label thatcan be used in every state. This effectively prevents dairymanufacturers and milk retailers from truthfully labelingtheir products as rBGH free since it is significantly easier tohave no label than to make a different label for each state.94The companys settlement with the state of Illinois in 1997enabled Ben & Jerrys and other companies to market andlabel their products nationwide as not produced with rBGH

As a result of the settlement, Ben & Jerrys products includethe disclaimer, the FDA has said no significant differencehas been shown and no test can now distinguish betweenmilk from rBGH treated and untreated cows.95


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In 2007 and 2008 a number of states, at the urging ofgroups backed by Monsanto,96 made significant moves torestrict the type of rBGH free labeling that could appear ondairy products. AFACT, a pro-rBGH organization that wascreated during this time and founded in part by Monsanto,

lobbied for the passage of labeling rules in many of thesestates.97 Some states, such as Utah,98 had proposals that

were modeled after FDA guidelines, while others, includ-ing Ohio, made more specific requirements in terms of thetype, size, and location of FDAs disclaimer.99 Missouri andPennsylvania went even further and attempted to ban anymention of an absence of rBGH.100 In Pennsylvania, the agri-cultural secretary attempted to create an outright ban on anyrBGH labeling, but this was reversed due to consumer back-lash and reduced to a rule that was similar to the originalFDA proposal.101 Missouris proposal was met with a similarreaction, and due to consumer protest the original bill had to

be modified102 before eventually dying in committee.103

With state legislatures and agriculture departments aroundthe country continuing to grapple with this issue, the fightover labeling rBGH is not over. However, industry supportfor these bills may begin to change now that Monsanto hassold all of its rBGH operations to Elanco, a division of thedrug manufacturer Eli Lilly.104

rBGH Has a New Owner

In August 2008, pharmaceutical giant Eli Lilly announcedthat it was acquiring Monsantos rBGH operations for $300

million.105 Posilac (Monsantos brand name for rBGH) andits supporting operations became part of Eli Lillys Elancodivision, which handles animal health and nutrition.106Elanco was already the exclusive international seller ofPosilac in the decade preceding the acquisition.107 Amongother things, Elanco sells antibiotics that are used to treatmastitis in dairy cows. 108

Eli Lilly is the pharmaceutical company responsible for Pro-zac and other psychiatric drugs, as well as the Viagra com-petitor Cialis and a number of other medications used totreat various conditions, including cancer.109 Lilly reported$18.6 billion in revenue and almost $3 billion in profit in

2007, significantly more than Monsantos $11.3 billion inrevenue and $2 billion in profit that fiscal year.110

It is easy to understand why Monsanto would sell its rBGHbusiness. The synthetic hormone is banned for commercialsale in Canada and the European Union,111 national retail-ers and food companies like Kroger and Starbucks refuse touse milk that was produced with rBGH112 and Dean Foods,the largest milk distributer in the United States,113 statesthat virtually all of its milk is sourced from cows not treated

with the artificial hormone.114 Both Yoplait and Dannonalso announced they would be dropping rBGH from theirproducts.115 Even Wal-Mart now uses rBGH-free sourcesfor its private label milk.116 In fact, Monsantos stock wentup 4.63 percent on the day that it became news that it was

eliminating rBGH from its portfolio. It was not immedi-ately clear why Eli Lilly decided to acquire the rBGH opera-tions at this point in time, and in fact, Lillys stock declinedthat same day.117

In its quarterly conference call following the acquisition, Lil-ly touted the decision as part of a strategy to build its global

business.118 The company did not elaborate further, butgiven the supposed benefits of the product and the currentpush to expand animal agriculture around the world, it ispossible that Lilly will market rBGH to developing countriesas a tool for increasing domestic milk production. RBGH iscurrently approved for use in twenty countries,119 includingthe United States, South Africa, Brazil, Columbia, Hondu-ras, Kenya and Mexico.120 Whether Eli Lilly will be promot-ing this product ethically, however, remains to be seen, asEli Lilly has been involved in a number of controversies overits questionable business and marketing practices.

On January 15, 2009, Lilly agreed to settle an off-labelpromotion case with the U.S. Justice Department for a re-cord-setting $1.42 billion.121 Off-label refers to the processof using drugs for purposes that have not been approved byFDA.122 While doctors have discretion to prescribe medica-tions for non-approved purposes, it is illegal for drug com-

panies to promote and market the drugs for these uses.123

This was the largest sum for both a corporate whistleblowerclaim as well as the largest criminal fine ever imposed bythe U.S. upon a single company.124 Lilly was facing criminaland civil charges for violating the Food, Drug and Cosmetic

Act and was accused of engaging in a multi-year scheme topersuade doctors to prescribe its anti-psychotic drug Zy-prexa for use in two groups of patients for whom the drug

was particularly risky and not approved, children and theelderly. 125 As part of the settlement, Lilly agreed to pleadguilty to one misdemeanor charge of illegally marketing thedrug for use in treating the elderly for various symptoms ofdementia.126 The company paid a $615 million penalty for

the criminal charges and also paid $800 million to stop thecivil investigation from proceeding further.127 In addition,Lilly agreed to be monitored for five years by a federal re-

view organization that will assess and report on the com-panys practices, policies, and procedures.128

Lilly had already settled claims for improperly marketingZyprexa prior to this latest agreement. In October of 2008,Lilly paid out $62 million to 33 states for improperly mar-keting the drug,129 this time setting a record for the largest


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sum in a state consumer protection claim.130

The companywas accused of the same illegal behavior, which was pro-moting the drug for uses that were not approved by FDAand urging doctors to prescribe it for those uses.131

In addition, in 2005 Lilly pled guilty to similar charges of il-legal off-label promotion of its drug Evista. Evista was onlyapproved for the prevention and treatment of osteoporosisin post-menopausal women. However, Lilly was allegedlypromoting the drug as reducing the risk of cardiovasculardisease and breast cancer, a use that FDA had specificallyrejected. 132 Lilly agreed to pay a $36 million to settle theEvista case with the U.S. government.133

Lilly also happens to market another drug, Gemzar, whichis approved by FDA for treating metastatic breast cancer.134It needs to be questioned whether Lilly knows that cowsinjected with rBGH show elevated levels of the hormoneIGF-1 in their milk, and that this hormone has been linkedto 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 thepeer-reviewedNew England Journal of Medicine criticizedLillys marketing tactics for the drug Xigris, which is usedto treat sepsis, otherwise known as blood poisoning. TheFDA approved the drug in 2001, although not without somecontroversy. The approval was based on a single problem-atic trial of the drug, and half of FDA advisory panel votedto require another confirmation trial before approval.136

When initial Xigris sales were lower than expected, Lillyhired a public relations firm to help boost sales of the drug.137 During the period that this PR campaign was takingplace, issues continued to arise over the safety and effec-tiveness 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 beparticularly unethical marketing strategies;139 as a resultof Lillys actions, the NEJM article called for a system ofcreating drug-use guidelines that prohibit pharmaceuticalcompanies from funding or influencing these guidelines.140

Lilly has repeatedly engaged in illegal and unethical mar-keting of its drugs to doctors and has paid millions ofdollars in fines and settlements for doing so. The company


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has also used marketing and promotion to increase thesale of drugs suspected of having ill effects. The moneylost settling lawsuits does not seem to have deterred Lillyfrom continuing its behavior; the company appears to haveaccepted the fines as just another cost of doing business. It

would seem then that Eli Lilly is an excellent choice to takeover the reins of a such a controversial product as rBGH,as the company has demonstrated a willingness to engagein illegal marketing to sell its products and may very wellcontinue to use unethical tactics to sell rBGH to unsuspect-ing people around the world.

Community Responses to rBGH

The road to a healthier, more humane dairy productionsystem starts with the removal of rBGH from our dairy sup-ply. A 2008 poll showed that more than 90 percent of U.S.

consumers want the right to choose rBGH-free productsand want them to be labeled.141 RBGH use is falling amongU.S. dairies, too: the most recent USDA survey of U.S. dairyproduction estimated that rBGH was used on 17.2 percentof cows, compared to 22.3 percent five years earlier.142 It isstill fairly common among industrial dairies, though; 42.7percent of large-scale industrial dairies used it in 2007,compared to 9 percent of small operations and 29 percentof midsized dairies.143

Milk consumers around the country have already madehuge headway by urging food companies to go rBGH-free. Thanks to their pressure, major companies including

Kroger,144 Wal-Mart,145 Hood,146 Dannon,147 Yoplait148 andothers have phased out the use of rBGH milk in some or allof their dairy products.

If so many companies are no longer accepting rBGH milk,where is the remaining milk going? One possibility is thatit is being funneled to U.S. schoolchildren through schoolfood programs, which require that milk be offered withevery school lunch. Schools have therefore become anotherarea where pressure from consumers in this case parents,teachers, and school board members has turned the tideagainst rBGH use. Following the release of rBGH on themarket and consumer outcry over it, National GeographicSocietys Green Guide reported in 1997 that numerousparent and teacher associations have passed rBGH-freeresolutions, and over 100 school systems across the coun-try buy only rBGH-free milk.149 The school board of River

Valley, Wisconsin was one of the early participants in thecampaign and in the early 1990s passed a resolution askingthat the district not purchase milk from suppliers who haveknowingly accepted milk from farmers using rBGH. Boardmember and dairy farmer Randy Smith, who introducedthe resolution, was quoted in papers saying, Ive got a lot ofparents in the district that have told me that they dont wanttheir children to drink rBGH milk. As a dairy farmer, I don

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 sourcemilk that is not rBGH free. They do so either because theyare not aware that they have the option to choose rBGH-free milk or because they fear it would be too expensive;the school lunch program is notoriously underfunded, withmost public schools making do with federal funding equiva-lent to $2.57 per child per meal.151

A 2008 poll showed thatmore than 90 percent ofU.S. consumers want theright to choose rBGH-freeproducts and want them tobe labeled.

A schoolgirl in Philadelphia voices her support for rBGH-freeschool milk during Food & Water Watchs Know Your Milk Day inMarch 2009.


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Take Action

You can help get rBGH out of our schools and the dairysupply by taking action in your community:

Help make your school district rBGH-free. Someschool districts have successfully built rBGH-free milk intotheir school wellness policies,152 (in 2004, all districts wererequired to draft a wellness policy that addressed physi-cal activity, nutrition, and other issues) and others haverequired the dairy companies that contract with them tosupply rBGH-free milk. You can prepare a presentationfor parent groups or your local school board about theproblems with rBGH and ask the school board to adoptan rBGH-free policy. For more resources on how to make

your district rBGH-free, see Food & Water Watchs SchoolMilk Campaign, www.foodandwaterwatch.org/food/school-milk.

Preserve your right to know. Bills have been intro-duced in several states that would prohibit farmers anddairy processors from labeling their milk as rBGH-free.These bills could keep the market for rBGH milk alive bypulling the wool over consumers eyes. Check to see if alabeling bill has been introduced in your state and organizeletter-writing and call-in campaigns to your state legisla-tors. Let them know that they should preserve consumersright to information about their food and preserve rBGH-free labeling!

Tell dairy providers and restaurants to go rBGHfree. Past consumer campaigns have successfully turnedthe tide against rBGH use but there is still much to bedone. With labeling under attack, its more importantthan ever to send a clear message to dairy companies thatconsumers want rBGH-free milk and will choose it if it isproperly labeled. If the dairy products you buy are notlabeled rBGH free, then call the dairy company, ask themif their suppliers use the drug, and tell them that you areswitching to an rBGH-free brand unless they commit toprohibiting its use. If the company claims their products

are already rBGH-free, tell them to label their products sothat consumers can make the right choice. For informationon dairy products that are already produced without rBGHgo to: http://www.foodandwaterwatch.org/take-action/consumer-tools/milk-tip/rbgh-free-guide.

Ask FDA to revoke its approval of rBGH. Theresearch that has been done since FDA approved rBGHin 1993 has raised enough concerns that Canada and theEuropean Union refused to approve the drug in 1998 and1999.153 The FDAs approval process was nontransparentand 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 notbe risking public health by continuing to allow rBGH use.The FDA should revoke rBGH approval and appoint anunbiased panel of scientists to carry out a thorough, publicreview of existing research. Tell your members of Congressthat you are concerned about rBGH in the dairy supply.They should bring attention to the issue through hearingsand should follow the lead of Canada and the EU by in-structing FDA to revoke its approval of rBGH.

With labeling underattack, its more importantthan ever to send aclear message to dairycompanies that consumerswant rBGH-free milkand will choose it if it is

properly labeled.

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


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Endnotes

1 Collier, Robert. Regulation of rbST in the US.AgBioForum, vol 3no. 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 athttp://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 onPublic Health Aspects of the Use of Bovine Somatotrophin. Availableat http://ec.europa.eu/food/fs/sc/scv/out19_en.html. March 1999.

3 Monsantos BST barely beat tomato to market. The Chicago Sun-Times. March 20, 1994 at 28.

4 U.S. General Accounting Office. Comments on FDA employees al-leged conflicts of interest in drug approval. (B-257122). October 19,1994, at 6.

5 Cow Hormone no threat to humans, panel says. The ChicagoTribune. April 1, 1993 at 4.

6 U.S. General Accounting Office. Comments on FDA employees al-leged conflicts of interest in drug approval. (B-257122). October 19,

1994 at 6.7 U.S. General Accounting Office. Recombinant bovine growth hor-

mone: FDA approval should be withheld until the mastitis issue isresolved. (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 GrowthHormone; Adequacy of Marketing Research Challenged. TheWashington 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 PressInternational. March 31, 1993.

13 Kusserow, Richard P. Audit of issues related to the Food andDrug Administration review of bovine somatotropin. Office of the

Inspector General. (A-15-90-00046). February 21, 1992 at 6.

14 Kusserow, Richard P. Audit of issues related to the Food andDrug Administration review of bovine somatotropin. Office of theInspector General. (A-15-90-00046). February 21, 1992 at 6.

15 Kusserow, Richard P. Audit of issues related to the Food andDrug Administration review of bovine somatotropin. Office of theInspector General. (A-15-90-00046). February 21, 1992 at 6.

16 Siler, Julia Flynn. All things right and dutiful: a vet who blew thewhistle. Business Week. September 2, 1991 at 75; Schneider, KeithF.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 ofdrug for milk cows. The New York Times. January 12, 1990 atA21.

18 Siler, Julia Flynn. All things right and dutiful: a vet who blew thewhistle. 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 thewhistle. Business Week. September 2, 1991 at 75.

20 Schneider, Keith. F.D.A. accused of improper ties in review of drugfor milk cows. The New York Times. January 12, 1990 at A21.

21 See U.S. General Accounting Office. Recombinant bovine growthhormone: FDA approval should be withheld until the mastitis issue isresolved. (B-248450). August 6, 1992 at 6.

22 See U.S. General Accounting Office. FDA strategy needed to addressanimal drug residues in milk. (B-246269). August 5, 1992.

23 U.S. General Accounting Office. Recombinant bovine growth hor-mone: FDA approval should be withheld until the mastitis issue isresolved. (B-248450). August 6, 1992 at 6.

24 Cruzan, Susan. U.S. Department of Health and Human Services, U.SFood and Drug Administration. FDA Response to GAO report onreview of bST. August 17, 1992.

25 U.S. General Accounting Office. Recombinant bovine growth hor-mone: FDA approval should be withheld until the mastitis issue isresolved. (B-248450). August 6, 1992 at 8 and 29.

26 U.S. General Accounting Office. Comments on FDA employees al-leged conflicts of interest in drug approval. (B-257122). October 19,1994 at 1.



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30 U.S. General Accounting Office. Comments on FDA employees al-leged 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 employeesalleged conflicts of interest in drug approval. (B-257122). October19, 1994 at 21-22.

32 Interim guidance on the Voluntary Labeling of Milk and MilkProducts From Cows That Have Not Been Treated With RecombinantBovine Somatotropin. 59 Fed. Reg. 6279, (February 10, 1994).

33 U.S. General Accounting Office. Comments on FDA employees al-leged conflicts of interest in drug approval. (B-257122). October 19,1994 at 23-24.

34 Gladwell, Malcolm. Biotech food products wont require specialrules, 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. TheWashington Post. December 23, 1999 at A19.





41 See U.S. General Accounting Office. Comments on FDA employeesalleged conflicts of interest in drug approval. (B-257122). October19, 1994 at 10-11, 12, 13.





46 See U.S. General Accounting Office. Comments on FDA employeesalleged conflicts of interest in drug approval. (B-257122). October19, 1994 at 18.

47 United States Food and Drug Administration, Freedom ofInformation summary for Posilac, Package Insert, November 1993.

48 United States Food and Drug Administration, Freedom ofInformation 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 CanadianVeterinary Medical Association Expert Panel on rBST. Availableat 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 ConsumerProtection. Report on Animal Welfare Aspects of the Use of BovineSomatotrophin. 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 CanadianVeterinary Medical Association Expert Panel on rBST. Available athttp://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_cv-ma-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 CanadianVeterinary Medical Association Expert Panel on rBST. Availableat 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 onAnimal Health and Animal Welfare on Aspects of the Use of BovineSomatotropin. March 1999 at 76.

53 United States Food and Drug Administration. Freedom ofInformation summary for Posilac. November 1993.

54 Smith, David, Harris, Anthony, Johnson, Judith, Silbergeld, Ellen,and Morris, Glenn. Animal antibiotic use has an early but importantimpact on the emergence of antibiotic resistance in human com-mensal bacteria. Proceedings of the National Academies of Science USA. Vol. 99, 2002 at 6434-9.

55 Hoben, D., Burvenich, C., and Heyneman, R. AntibioticsCommonly Used to Treat Mastitis and Respiratory Burst of BovinePolymorphonuclear Leukocytes.Journal of Dairy Science. Vol. 81,no. 2, 1998 at 403-410.

56 U.S. General Accounting Office. Recombinant bovine growth hor-mone: FDA approval should be withheld until the mastitis issue isresolved. (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 importantimpact on the emergence of antibiotic resistance in human commen-sal 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 TerrestrialEnvironment.Adv Agro. Vol. 87, 2005 at 1-54.

59 Graham, Jay, Price, Lance, Evans, Sean, Graczyka, Thaddeus, andSilbergeld, Ellen. Antibiotic-resistant enterococci and staphylococciisolated from flies collected near confined poultry feedingoperations.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 ofantibiotic-resistant Salmonella from retail ground meats.N Engl JMed. 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; publishedJanuary 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-resistantStaphylococcus aureus in meat.Int J Food Microbiology. Article inPress, 2009.

61 Centers for Disease Control and Prevention. Get Smart: KnowWhen Antibiotics Work. Available at http://www.cdc.gov/drugresistance/community/campaign-info.htm. Accessed February4, 2009.

62 McEwen, Scott, Black, William, and Meek, Alan. Antibiotic Residues(bacterial inhibitory substances) in the milk of cows treated underlabel and extra-label conditions. Can Vet J. Vol. 33 no. 8, August1992, at 527-534.

63 U.S General Accounting Office. FDA Strategy Needed toAddress Animal Drug Residues in Milk. Report to theHouse Human Resources and Intergovernmental RelationsSubcommittee, Committee on Government Operations. August1992 at 2.

64 U.S. General Accounting Office. Recombinant bovine growthhormone: FDA approval should be withheld until the mastitis issueis resolved. (B-248450). August 6, 1992 at 6.

65 Mellon, Margaret, Benbrook, Charles, and Benbrook, Karen.Hogging It: Estimates of Antimicrobial Abuse in Livestock. Unionof Concerned Scientists. January 2001.

66 European Commission. Report on Public Health Aspects of theUse of Bovine Somatotrophin. Food Safety From the Farm to theFork. March 15-16, 1999.


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67 European Commission. Report on Public Health Aspects of the Useof Bovine Somatotrophin. Food Safety From the Farm to the Fork.March 15-16, 1999.

68 European Commission. Report on Public Health Aspects of the Useof 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 ofrecombinant human insulin-like growth factor-1 in rats.Journal ofPharmacology and Experimental Therapeutics. Vol. 283, no. 2, July1997 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 HealthImpacts Of The Use Of Recombinant Bovine Somatotropin In DairyProduction. Consumers Union. September 1997.

70 Yu H and Rohan T. Role of the Insulin-Like Growth Factor Familyin Cancer Development and Progression.Journal of the NationalCancer 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. Availableat http://www.nursingworld.org/MainMenuCategories/OccupationalandEnvironmental/environmentalhealth/PolicyIssues/HealthyFoodinHealthCare.aspx. Accessed April 10, 2009.

72 Steinman, Gary. Mechanisms of twinning. VII. Effect of diet andheredity on the human twinning rate.Journal of ReproductiveMedicine. Vol. 51, no. 5, 2006 at 405-410.

73 North Shore-Long Island Jewish Health System. Press release: Studyby LIJ Obstetrician finds that a womans chances of having twins canbe 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 CanadianVeterinary Medical Association Expert Panel on rBST. November1998, at Section 4.

75 US Department of Agriculture, National Agricultural StatisticsService. 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 StatisticsService. 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 StatisticsService. 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 2007at 79.

79 U.S. Department of Agriculture, Economic Research Service. Currentand 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 theConventional Analysis. Available at www.nffc.net/Pressroom/Presspercent20Releases/2009/Bunting percent20- percent20Dairy per-cent20Farm 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 PriceGroup (Dairy). Available at http://www.ers.usda.gov/Data/FarmToConsumer/pricespreads.htm. Accessed August 7, 2008.

82 US Department of Agriculture, Economic Research Service. PriceSpreads 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 MilkProducts From Cows That Have Not Been Treated With RecombinantBovine Somatotropin. 59 Fed. Reg. 6279, (February 10, 1994).

84 Interim guidance on the Voluntary Labeling of Milk andMilk Products From Cows That Have Not Been Treated WithRecombinant Bovine Somatotropin. 59 Fed. Reg. 6279, (February10, 1994).

85 Interim guidance on the Voluntary Labeling of Milk andMilk Products From Cows That Have Not Been Treated WithRecombinant Bovine Somatotropin. 59 Fed. Reg. 6279, (February10, 1994).

86 Rosenfeld, Steven P. Dairy cooperative says it will fight Monsantosuit. The Associate Press. February 21, 1994.

87 Puzo, Daniel P. Conflict of interest alleged in BGH approval. TheLos Angeles Times. April 21, 1994 at H2.

88 U.S Food and Drug Administration. [Press release]. FDA WarnsMilk Producers to remove hormone free claims from the labeling ofdairy 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. Monsantos cash cow trips milk alarm. TheWashington Post. March 1, 1994 at D20.

91 Gilgoff, Henry. Dairy labels go sour; its hard to milk antihormonesentiment. New York Newsday. March 24, 1994 at A49.

92 Wu, Olivia. Dairy companies sue Illinois to allow change inlabels. Chicago Sun-Times. May 8, 1996 at A14; Berselli, Beth.Settlement reached in hormone labeling case; Ben and Jerrys,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; Benand Jerrys, states agree food makers can indicate absence of addedproduct. The Washington Post. August 15, 1997 at A22.

94 Ben and Jerrys, 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 Jerrys,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; Benand Jerrys, states agree food makers can indicate absence of addedproduct. The Washington Post. August 15, 1997 at A22.

96 Melcer, Rachel. Lawmakers consider bill to restrict labels on milkcontainers. 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 milkcontainers. St. Louis Post-Dispatch. April 17, 2008 at B1; Avril,Tom. Hormone labeling of Pa. milk to end. The PhiladelphiaInquirer. December 23, 2007 at A01.

101 Malloy, Daniel. State reverses on dairy labeling, allows hormoneclaims. Pittsburgh Post-Gazette. January 18, 2008 at A1.

102 Melcer, Rachel. Lawmakers consider bill to restrict labels on milkcontainers. 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=154026. Accessed 04/01/09.

104 Clapp, Stephen. Kansas is latest battleground in rBST-free label-ing fight. Food Chemical News. December 22, 2008 at pg 5; EliLilly. [Press release]. Elanco Announces Acquisition of Posilac(R)Dairy Business. August 29, 2008.

105 Eli Lilly. [Press release]. Elanco Announces Acquisition ofPosilac(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.


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110 Monsanto. Securities and Exchange Commission. 10-K filing.October 24, 2008 at 49; Securities and Exchange Commission. 10-Kfiling. October 21, 2008 at 18.

111 Yousfi, Jennifer. Monsanto sells off controversial milk-hormone tofocus on seed product lines. Money Morning. August 23, 2008.

112 Yousfi, Jennifer. Monsanto sells off controversial milk-hormone tofocus 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 ofMilk from Cows Treated with rBST by August 2009. February 2,2009; Heller, Lorraine. Dannon removes growth hormone fromdairy products. Dairyreporter.com. February 23, 2009.

116 Wal-Mart. [Press release]. Wal-Mart Offers Private Label MilkProduced without Artificial Growth Hormone. March 21, 2008.

117 Yousfi, Jennifer. Monsanto sells off controversial milk-hormoneto 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 pres-

sure 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 onDrug. 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 onDrug. New York Times. Jan. 14, 2009.

124 Fisk, Margaret Cronin et al. Lilly to pay biggest fine ever to endZyprexa Probe. Bloomberg News. Jan. 15, 2009.

125 Harris, Gardner. Lilly Said to Be Near $1.4 Billion Settlement onDrug.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 endZyprexa Probe.Bloomberg News. Jan. 15, 2009.

128 Fisk, Margaret Cronin et al. Lilly to pay biggest fine ever to endZyprexa Probe.Bloomberg News. Jan. 15, 2009.

129 Berenson, Alex. 33 states to get $62 million in Zyprexa case settle-ment. New York Times. Oct. 6, 2008.



132 U.S. Department of Justice. [Press release]. Eli Lilly and companyto pay U.S. $36 million relating to off-label promotion. Dec. 21,2005. Although in 2007, FDA did approve the use of Evista to reducethe risk of breast cancer in post-menopausal women. See FDAApproves New Uses for Evista. FDA News. September 14, 2007.

133 U.S. Department of Justice. [Press release]. Eli Lilly and companyto 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 OfThe Use Of Recombinant Bovine Somatotropin In Dairy Production.Consumers Union. September 1997.

136 Eichacker, Peter Q., M.D. et al. Surviving Sepsis PracticeGuidelines, Marketing Campaigns, and Eli Lilly.New EnglandJournal of Medicine, vol.355, iss.16. Oct. 19, 2006 at 1640.





141 Consumer Reports National Research Center, 2008, Food LabelingPoll 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 2007at 79.

144 Kroger Co. [Press release]. Kroger to Complete Transition toCertified rBST-Free Milk by Early 2008. August 1 2007.

145 Lentini, Nina. Wal-Marts 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 dairyproducts. Dairyreporter.com. February 23, 2009.

148 General Mills. [Press release]. General Mills AnnouncesCommitment to Make Yoplait Yogurt Products 100 Percent Free ofMilk from Cows Treated with rBST by August 2009. February 2,2009.

149 Baxter, Carol. Reading, riting and rBGH: What Kind of Milk is BeingServed in Your Childs School?National Geographic Green GuideNo. 36. Available online at http://www.thegreenguide.com/doc/36/milk . March, 1997.

150 Bio/Technology/Diversity News Bulletin. School Districts say Noto BGH. Vol. 2, No. 21, December 1993; Food & Water Watch staffinterview with John Kinsman, Wisconsin dairy farmer (September 102008).

151 Food Research and Action Center. Federal Food Programs NationaSchool Lunch Program. Available at http://www.frac.org/html/fed-eral_food_programs/programs/nslp.html. Accessed March 31, 2009.

152 See, for example, the San Francisco Unified School District Wellnesspolicy, available at http://www.sfusdfood.org/; see also the BerkeleyUnified School District Wellness Policy, available at http://www.chefann.com/html/tools-links/BUSD/BUSD-documents/BUSD-Wellness-Policy.pdf.

153 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al.Health Canada, Drug and Health Products. Report of the CanadianVeterinary Medical Association expert panel on rBST. Availableat http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_cvma-rap_acdv_tc-tm-eng.php. November 1998, at Section7; Groves, Martha. Canada Rejects Hormone that Boosts CowsMilk Output.Los Angeles Times, January 15 1999; EuropeanCommission, Directorate General for Health and ConsumerProtection. Report on Public Health Aspects of the Use of BovineSomatotrophin. Available at http://ec.europa.eu/food/fs/sc/scv/out19_en.html. March 1999.


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

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