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rBGH

How Artificial Hormones


Damage the Dairy Industry
and Endanger Public Health
About Food & Water Watch
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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
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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 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 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 artifi-
cial 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 This report will begin with a background on the science,
use of this controversial drug has resulted in an increas- regulation and politics of rBGH, new risks identified by
ing number of companies moving to rBGH-free milk and scientific research, the influence of Monsanto, and informa-
making sure that consumers know they’ve made the change tion on drug giant Eli Lilly, the new owner of rBGH. We’ll
by labeling their products as such. But across the country, tell the stories of successful community, state, and national
legislators and state regulators are responding to industry campaigns to kick the dairy industry off the rBGH wagon.
pressure by trying to ban rBGH-free labels on dairy prod- And we’ll finish up with suggestions for action that will help
ucts. After years of successful campaigns that educated readers become advocates for improving the health and
dairy consumers about the risks of rBGH, banned rBGH safety of the dairy supply.
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.
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 sev-
eral 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 com-
mercial 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 investiga-
tion.7 Monsanto was not the only company to petition FDA mation provided by the sponsor companies when it deter-
for approval of its rBGH drug — competitors at the time mined that exposure to increased levels of IGF-1 was safe.15
included Eli Lilly, American Cyanamid and Upjohn — but
FDA only approved Monsanto’s “Posilac” brand.8 One scientist at FDA who did speak up and question the
approval process of rBGH was subsequently fired. Richard
Outside observers first expressed concern that FDA was Burroughs was a veterinarian at FDA and worked on the
ignoring the negative animal health impacts of the artificial review of rBGH from 1985 until 1988, when he was termi-
hormone early on in the approval process.9 Central to their nated, allegedly for incompetence.16 Soon after his termina-
concern were studies suggesting that rBGH use increased tion, Burroughs became a vocal public critic of FDA’s review
the frequency of mastitis, an infection of the cow’s udder of rBGH, and stated that he was fired after a dispute with
that requires treatment with antibiotics. These conclusions his superior about how to interpret the sponsor companies’
were initially downplayed by Monsanto,10 and FDA denied studies.17 Burroughs alleged that FDA was working too
them as late as 1993, when Gerald Guest, Director of FDA’s closely with industry, Monsanto was manipulating data that
Center for Veterinary Medicine and the person who had the it submitted, and FDA was ignoring safety problems with
final say on rBGH’s approval,11 testified in a hearing that the drug.18 In 1991, the Federal Merit Systems Protection
rBGH did not increase the severity or duration of mastitis Board found that Burroughs was improperly terminated be-
in cows.12 cause the agency had not followed the formal rules in firing
him, and it subsequently ordered FDA to reinstate him.19
FDA also took a cursory look at the human health impacts of
drinking milk produced with rBGH. FDA initially concluded Burroughs’ allegations were serious enough that at the
that the drug was safe for humans based on rat studies prompting of Congress, the General Accounting Office
submitted by each of the four sponsor companies, as well (GAO, now the Government Accountability Office) conduct-
as experiments conducted in the 1950s, in which rBGH did ed an in-depth investigation into FDA’s review of the rBGH
not produce any growth when injected into children with application.20 The GAO recommended that FDA’s approval
dwarfism.13 FDA only began to look at secondary health is- be delayed until further studies could be performed on the
sues caused by a related hormone called IGF-1 in 1988, after drug’s health effects, particularly regarding the indirect
the agency learned that human and bovine versions of the effects of mastitis in treated cows.21 The GAO was already
growth hormone were identical (see “Hormonal effects in concerned about the levels of animal antibiotics that were
humans” on page 5).14 However, according to the Inspector making their way into humans through milk consump-
General audit of the rBGH review, the FDA relied on infor- tion,22 and the increased levels of antibiotics that would be

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Food & Water Watch

used to treat mastitis could potentially lead to even greater Conflicts of interest?
levels of antibiotic residue in milk.23 The FDA, however, FDA’s analysis of the human health impact of rBGH was
disagreed and reaffirmed its initial conclusion that the arti- not the only cause for alarm during the review process.
ficial hormone was safe.24 Three FDA employees working on the synthetic hormone
application appeared to have such close ties with rBGH
Unfortunately, consumer, farm and animal welfare groups manufacturer Monsanto that at the request of Represen-
could not directly critique the studies submitted to FDA tatives George Brown from California, David Obey from
by the four companies and reviewed by the GAO. In FDA Wisconsin and Bernie Sanders from Vermont, the GAO
drug approvals, company studies are generally considered investigated them for conflicts of interest.26
proprietary business information and are therefore confi-
dential. It is therefore impossible for the public to know Michael Taylor, the first target of the GAO probe, started
which studies and what data FDA bases its decisions on his career in 1976 as an attorney with FDA before leaving
until after the decision is made, and even then, the specific in 1981 to join the law firm of King & Spalding.27 While at
data generally remain confidential. While the GAO report King & Spalding, one of Taylor’s clients was Monsanto,28
criticizing FDA’s approval process had access to the FDA and Taylor drafted a memo for Monsanto on whether it
studies, it could not present the specific data to the public would be constitutional for states to adopt different rules
in order to back up its assertion that there were indirect hu- regarding the labeling of rBGH.29 Taylor left King & Spald-
man health impacts from increased mastitis in cows treated ing in 1991 to join FDA as the Deputy Commissioner of
with rBGH.25 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 is-


sues 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 em-


ployee of Monsanto. While at Monsanto, she was respon-
sible 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 divi-
sion 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 Ac-
cording to the GAO, she did not technically violate any con-
flict 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 per-
formed 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 scien-
tific community also understands more now about impacts
“beyond the barn” — how treating dairy cows with a syn-
thetic 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 con-
sume the cows’ milk, and that it indirectly impacts human
health by driving the emergence and spread of antibiotic-
resistant 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 Posi-
lac 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 prob-
lems.47 A total of 16 different animal health impacts were
listed on the Posilac package insert.48

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 sub-
stantially increased the risk that cows would not be able to
conceive, but some evidence suggested that it also increased
tween her advisor and Monsanto.43 Monsanto also provided
the chance that a cow would bear twins or triplets. There
support for several rBGH studies to be performed at Cornell,
was also evidence of increased risk of cystic ovaries.49 A
and some of these were submitted with the rBGH applica-
1999 study published by the European Commission’s Sci-
tion as pivotal studies.44 During Sechen’s time at FDA, she
entific Committee on Animal Health and Animal Welfare
performed a considerable amount of work on rBGH, includ-
found that pregnancy rates in rBGH-treated cows fell by
ing publishing articles on the drug in outside journals based
between 7 percent and 27 percent compared to cows not
on her former research, and then evaluating several of those
treated with the synthetic hormone.50
same articles in her official capacity as a reviewer of the
artificial hormone application.45 Yet the GAO found that she
The Canadian veterinary experts found that as a conse-
did not have a conflict of interest since Monsanto had never
quence of these and other health impacts of rBGH, includ-
employed her or directly given her funding.46
ing evidence that treated cows experienced a 50 percent
increase in the risk of lameness compared to cows that
Despite multiple ties between FDA and Monsanto, the GAO
were not treated, rBGH increased the chance that some
failed to address a relevant question in its report: why did
cows would be culled, or pulled from the herd and slaugh-
FDA approve Monsanto’s version of the rBGH drug over the
tered.51 Both Canada and the EU refused to approve the
other three manufacturers? Given that three FDA officials
drug because of outstanding questions related to animal
with former ties to Monsanto were the subjects of the inves-
welfare.52
tigation, 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.

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Food & Water Watch

Antibiotic resistance
The increased frequency of mastitis, an udder infection, is Recent research shows that
one of the main animal welfare impacts of rBGH use and
is included in the warning label on Posilac.53 In addition when present in the human
to causing the cows pain, mastitis has a secondary ef-
fect: it requires treatment with antibiotics, and increased
body at elevated levels,
antibiotic use in animal agriculture has been linked to the
development of antibiotic-resistant bacteria that can sicken
IGF-1 increases the risk of
humans.54 breast, colon, prostate and
Many of the antibiotics commonly used to treat mastitis other cancers.
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
dairy cows are treated with rBGH, their bodies increase
may have to increase their use of antibiotics.56 Antibiotic
production of a protein called insulin-like growth factor-1
use in dairy operations exposes bacteria to the antibiotics,
(IGF-1).66 IGF-1 circulates in cows’ blood and makes its way
contributing to the development of drug-resistant bacte-
into the animal’s milk;67 it appears to survive pasteurization
ria.57 As antibiotic-resistant bacteria spread, they can be
and is consumed by humans when they drink the milk.68
transferred to humans through the water or air,58 by flies,59
or on the meat that humans consume.60 The U.S. Institute
Humans naturally produce their own IGF-1, and they also
of Medicine has identified antibiotic resistance as one of the
consume IGF-1 in the milk of cows not treated with rBGH.
key threats to health in the United States and the federal
However, because rBGH increases the amount of IGF-1 that
Centers for Disease Control and Prevention has identified
cows produce, humans drinking milk from treated cows
resistance as a top concern.61
will consume more IGF-1 than they otherwise would. What
could that mean for human health?
Researchers are also concerned about the potential for
antibiotic residues to show up in the milk of cows being
A lot, as it turns out. The early research used by FDA to re-
treated with the drugs. Antibiotic residues in milk are a
view Posilac suggested that even if humans ingested IGF-1
significant concern when dairy farmers or veterinarians use
from treated cows’ milk, the human digestive process would
antibiotics in ways other than that directed on the label,62
destroy it. But more recent research indicates that most
a practice that the GAO has called “routine.”63 Indeed, the
IGF-1 actually survives digestion. IGF-1 binds to casein, the
FDA’s failure to consider the effect rBGH use might have on
main protein in milk, and may be absorbed into the human
antibiotic residues in milk was one main reason the GAO
bloodstream along with it.69
recommended withholding approval.64
Recent research also shows that when present in the human
It is hard to know what portion of overall antibiotic use
body at elevated levels, IGF-1 increases the risk of breast,
takes place on U.S. farms and ranches because the federal
colon, prostate and other cancers,70 although scientists still
government does not track it, but estimates suggest that as
do not fully understand why. The American Nurses Associ-
much as 70 percent of all antibiotics used for any purpose
ation determined that the risk to human health was serious
in the United States are fed to animals that are not sick,
enough to warrant the passage of a resolution in 2008 call-
used as growth promoters or to keep them from becoming
ing for hospitals and healthcare organizations to eliminate
ill.65 Treatment of cows for mastitis would be in addition to
the purchasing of dairy products from rBGH-treated cows
this number. Anything we can do to reduce the use of anti-
and to educate nurses on the effects of rBGH.71
biotics on animals will help reduce the spread of antibiotic-
resistant bacteria, including ending the use of rBGH in
dairy production. Harming human reproduction?
It is well known that rBGH impacts cows’ reproductive
systems, but new research suggests that IGF-1 may also af-
Hormonal effects in humans fect human reproduction. A 2006 study comparing women
There is little evidence that rBGH itself impacts humans
who consume dairy products to women who do not found
when they drink milk from treated cows, but rBGH does
that the concentration of IGF-1 in the blood of women
appear to put human health at risk by increasing the levels
who consumed dairy was 13 percent higher than in vegan
of other chemicals that are linked to human illness. When
women. It also found that women who ate dairy products

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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 treat-
ment 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 farm-
ers felt like trying something new. Despite all of the health
problems that result for cows treated with rBGH, the arti-
ficial 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 help- in the early 1990s. Back then, a typical large dairy housed
ful to look at general trends that have shaped the dairy in- 500 cows; today, several thousand is the norm.76
dustry over the last 25 years. During this period, the num-
ber of dairies in operation in the United States fell sharply. Despite the falling number of dairies and cows, the amount
In 1993, the year that rBGH first came on the market, the of milk produced in the United States has increased since
United States was home to 157,000 dairies. Today we have 1993, from 150 million gallons to 170 million.77 Not all of
just over 71,000, a decline of 55 percent.75 The number of that increase can be attributed to rBGH, but some pre-
dairy cows has fallen less rapidly during this time, from 9.5 sumably can, given the role it plays in boosting cows’ milk
million to 9.1 million head, a testament to the fact that re- production. In 2007, nearly 43 percent of large-scale dair-
maining dairies are much larger on average than they were ies (over 500 head), 30 percent of mid-sized dairies, and 9
percent of small dairies used rBGH on their cows.78

Change in U.S. Milk Prices and Production, Dairy producers have been under pressure to increase their
1970-2006 production because dairy prices have been quite volatile
since 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 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 con-
cept 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 cus-
tomers, you’ll accept the lower price. At the same time, you
still have all those copy machines to pay off, so you’ll try

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Food & Water Watch

to increase the number of copies that you sell each day in labels to appear on milk, claiming that the practice was
order to make up for the price decline. In other words, you damaging its business.89
will increase the number of units sold to make up for the
lower price you receive for each unit. This is the same situ- Ben & Jerry’s was one company that made an immediate
ation in which dairy producers find themselves when prices and significant push to label its products as free of rBGH.
fall, and they tend to respond the same way – by increasing The Vermont-based ice cream manufacturer first included
the volume of milk they sell to make up for the lower price an rBGH-free label on its ice cream in February 1994,90 and
(see graph above). And in the mid-1990s, when producers aggressively defended that decision by continually modify-
heard about Posilac, some saw the drug as a way to do that. ing its label to in order to withstand challenges91 as well as
suing the state of Illinois in order to protect its right to label
Unfortunately, rBGH was no panacea. When they begin its products.92 Illinois was one of the first states to ban any
using it, dairy producers take on the added cost of buying labeling of an absence of rBGH, and this essentially made
the drug and treating their cows for the diseases associ- it impossible for Ben & Jerry’s to market their products
ated with it, including mastitis, reproductive problems, and nationwide as not produced with rBGH.93 A serious side
lameness. Meanwhile, actions by commodity speculators effect of state labeling requirements is that dairy compa-
impacted the complicated formulas used to set milk prices, nies can find it next to impossible to make one label that
80
and the prices that farmers received fell ever lower. 81 can be used in every state. This effectively prevents dairy
Today, for every dollar that consumers spend on milk, dairy manufacturers and milk retailers from truthfully labeling
farmers receive only $0.27 — 25 percent less than they their products as rBGH free since it is significantly easier to
received in 1993.82 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
Labeling label their products nationwide as not produced with rBGH.
When it approved rBGH, FDA found that since it could find As a result of the settlement, Ben & Jerry’s products include
no distinguishable difference between the milk that comes the disclaimer, “the FDA has said no significant difference
from cows treated with rBGH versus those that were not, has been shown and no test can now distinguish between
it could not require any label on milk that was produced milk from rBGH treated and untreated cows.”95
using the synthetic growth hormone.83 Given the amount of
controversy surrounding rBGH, this decision was surpris-
ing, 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 label-
ing 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 mislead-
ing, and a lengthy qualifying sentence stating FDA’s conclu-
sions 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 non-
rbST-treated cows.”85

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 let-
ters 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 com-
plained 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 with the artificial hormone.114 Both Yoplait and Dannon
groups backed by Monsanto,96 made significant moves to also announced they would be dropping rBGH from their
restrict the type of rBGH free labeling that could appear on products.115 Even Wal-Mart now uses rBGH-free sources
dairy products. AFACT, a pro-rBGH organization that was for its private label milk.116 In fact, Monsanto’s stock went
created during this time and founded in part by Monsanto, up 4.63 percent on the day that it became news that it was
lobbied for the passage of labeling rules in many of these eliminating rBGH from its portfolio. It was not immedi-
states.97 Some states, such as Utah,98 had proposals that ately clear why Eli Lilly decided to acquire the rBGH opera-
were modeled after FDA guidelines, while others, includ- tions at this point in time, and in fact, Lilly’s stock declined
ing Ohio, made more specific requirements in terms of the that same day.117
type, size, and location of FDA’s disclaimer.99 Missouri and
Pennsylvania went even further and attempted to ban any In its quarterly conference call following the acquisition, Lil-
mention of an absence of rBGH.100 In Pennsylvania, the agri- ly touted the decision as part of a strategy to build its global
cultural secretary attempted to create an outright ban on any business.118 The company did not elaborate further, but
rBGH labeling, but this was reversed due to consumer back- given the supposed benefits of the product and the current
lash and reduced to a rule that was similar to the original push to expand animal agriculture around the world, it is
FDA proposal.101 Missouri’s proposal was met with a similar possible that Lilly will market rBGH to developing countries
reaction, and due to consumer protest the original bill had to as a tool for increasing domestic milk production. RBGH is
be modified102 before eventually dying in committee.103 currently approved for use in twenty countries,119 including
the United States, South Africa, Brazil, Columbia, Hondu-
With state legislatures and agriculture departments around ras, Kenya and Mexico.120 Whether Eli Lilly will be promot-
the country continuing to grapple with this issue, the fight ing this product ethically, however, remains to be seen, as
over labeling rBGH is not over. However, industry support Eli Lilly has been involved in a number of controversies over
for these bills may begin to change now that Monsanto has its questionable business and marketing practices.
sold all of its rBGH operations to Elanco, a division of the
drug manufacturer Eli Lilly.104 On January 15, 2009, Lilly agreed to settle an “off-label”
promotion case with the U.S. Justice Department for a re-
cord-setting $1.42 billion.121 Off-label refers to the process
rBGH Has a New Owner of using drugs for purposes that have not been approved by
In August 2008, pharmaceutical giant Eli Lilly announced FDA.122 While doctors have discretion to prescribe medica-
that it was acquiring Monsanto’s rBGH operations for $300 tions for non-approved purposes, it is illegal for drug com-
million.105 Posilac (Monsanto’s brand name for rBGH) and panies to promote and market the drugs for these uses.123
its supporting operations became part of Eli Lilly’s Elanco This was the largest sum for both a corporate whistleblower
division, which handles animal health and nutrition.106 claim as well as the largest criminal fine ever imposed by
Elanco was already the exclusive international seller of the U.S. upon a single company.124 Lilly was facing criminal
Posilac in the decade preceding the acquisition.107 Among and civil charges for violating the Food, Drug and Cosmetic
other things, Elanco sells antibiotics that are used to treat Act and was accused of engaging in a multi-year scheme to
mastitis in dairy cows. 108 persuade doctors to prescribe its anti-psychotic drug Zy-
prexa for use in two groups of patients for whom the drug
Eli Lilly is the pharmaceutical company responsible for Pro- was particularly risky and not approved, children and the
zac and other psychiatric drugs, as well as the Viagra com- elderly. 125 As part of the settlement, Lilly agreed to plead
petitor Cialis and a number of other medications used to guilty to one misdemeanor charge of illegally marketing the
treat various conditions, including cancer.109 Lilly reported drug for use in treating the elderly for various symptoms of
$18.6 billion in revenue and almost $3 billion in profit in dementia.126 The company paid a $615 million penalty for
2007, significantly more than Monsanto’s $11.3 billion in the criminal charges and also paid $800 million to stop the
revenue and $2 billion in profit that fiscal year.110 civil investigation from proceeding further.127 In addition,
Lilly agreed to be monitored for five years by a federal re-
It is easy to understand why Monsanto would sell its rBGH view organization that will assess and report on the com-
business. The synthetic hormone is banned for commercial pany’s practices, policies, and procedures.128
sale in Canada and the European Union,111 national retail-
ers and food companies like Kroger and Starbucks refuse to Lilly had already settled claims for improperly marketing
use milk that was produced with rBGH112 and Dean Foods, Zyprexa prior to this latest agreement. In October of 2008,
the largest milk distributer in the United States,113 states Lilly paid out $62 million to 33 states for improperly mar-
that virtually all of its milk is sourced from cows not treated keting the drug,129 this time setting a record for the largest

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Food & Water Watch

sum in a state consumer protection claim.130 The company of drug promotion. In 2006, an article appearing in the
was accused of the same illegal behavior, which was pro- peer-reviewed New England Journal of Medicine criticized
moting the drug for uses that were not approved by FDA Lilly’s marketing tactics for the drug Xigris, which is used
and urging doctors to prescribe it for those uses.131 to treat sepsis, otherwise known as blood poisoning. The
FDA approved the drug in 2001, although not without some
In addition, in 2005 Lilly pled guilty to similar charges of il- controversy. The approval was based on a single problem-
legal off-label promotion of its drug Evista. Evista was only atic trial of the drug, and half of FDA advisory panel voted
approved for the prevention and treatment of osteoporosis to require another confirmation trial before approval.136
in post-menopausal women. However, Lilly was allegedly When initial Xigris sales were lower than expected, Lilly
promoting the drug as reducing the risk of cardiovascular hired a public relations firm to help boost sales of the drug.
disease and breast cancer, a use that FDA had specifically 137
During the period that this PR campaign was taking
rejected. 132 Lilly agreed to pay a $36 million to settle the place, issues continued to arise over the safety and effec-
Evista case with the U.S. government.133 tiveness of the drug, with increasing calls for further testing
of the product.138 While not accusing Lilly of illegal activity,
Lilly also happens to market another drug, Gemzar, which the NEJM article did shed light on what it considered to be
is approved by FDA for treating metastatic breast cancer.134 particularly unethical marketing strategies;139 as a result
It needs to be questioned whether Lilly knows that cows of Lilly’s actions, the NEJM article called for a system of
injected with rBGH show elevated levels of the hormone creating drug-use guidelines that prohibit pharmaceutical
IGF-1 in their milk, and that this hormone has been linked companies from funding or influencing these guidelines.140
to increased rates of breast cancer in humans.135
Lilly has repeatedly engaged in illegal and unethical mar-
In addition to its illegal off-label marketing campaigns, keting of its drugs to doctors and has paid millions of
Eli Lilly has also engaged in other questionable forms 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 unsuspect-
ing 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 sup-
ply. A 2008 poll showed that more than 90 percent of U.S.
consumers want the right to choose rBGH-free products A schoolgirl in Philadelphia voices her support for rBGH-free
and want them to be labeled.141 RBGH use is falling among school milk during Food & Water Watch’s “Know Your Milk Day” in
U.S. dairies, too: the most recent USDA survey of U.S. dairy March 2009.
production estimated that rBGH was used on 17.2 percent
If so many companies are no longer accepting rBGH milk,
of cows, compared to 22.3 percent five years earlier.142 It is
where is the remaining milk going? One possibility is that
still fairly common among industrial dairies, though; 42.7
it is being funneled to U.S. schoolchildren through school
percent of large-scale industrial dairies used it in 2007,
food programs, which require that milk be offered with
compared to 9 percent of small operations and 29 percent
every school lunch. Schools have therefore become another
of midsized dairies.143
area where pressure from consumers — in this case parents,
teachers, and school board members — has turned the tide
Milk consumers around the country have already made
against rBGH use. Following the release of rBGH on the
huge headway by urging food companies to go rBGH-
market and consumer outcry over it, National Geographic
free. Thanks to their pressure, major companies including
Society’s Green Guide reported in 1997 that “numerous
Kroger,144 Wal-Mart,145 Hood,146 Dannon,147 Yoplait148 and
parent and teacher associations have passed rBGH-free
others have phased out the use of rBGH milk in some or all
resolutions, and over 100 school systems across the coun-
of their dairy products.
try 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
A 2008 poll showed that the resolution, was quoted in papers saying, “I’ve got a lot of
more than 90 percent 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
U.S. consumers want the want to see a decline in consumption because of rBGH.”
The resolution passed the school board five to one.150
right to choose rBGH-free
Unfortunately, many school districts continue to source
products and want them to milk that is not rBGH free. They do so either because they
are not aware that they have the option to choose rBGH-
be labeled. free 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 equiva-
lent to $2.57 per child per meal.151

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Food & Water Watch

Take Action
You can help get rBGH out of our schools and the dairy
supply by taking action in your community:
With labeling under
attack, it’s more important
Help make your school district rBGH-free. Some
school districts have successfully built rBGH-free milk into than ever to send a
their school wellness policies,152 (in 2004, all districts were
required to draft a wellness policy that addressed physi- clear message to dairy
cal activity, nutrition, and other issues) and others have
required the dairy companies that contract with them to companies that consumers
supply rBGH-free milk. You can prepare a presentation
for parent groups or your local school board about the
want rBGH-free milk
problems with rBGH and ask the school board to adopt
an rBGH-free policy. For more resources on how to make
and will choose it if it is
your district rBGH-free, see Food & Water Watch’s School properly labeled.
Milk Campaign, www.foodandwaterwatch.org/food/
school-milk.

Preserve your right to know. Bills have been intro-


Tell dairy providers and restaurants to go rBGH
duced in several states that would prohibit farmers and
free. Past consumer campaigns have successfully turned
dairy processors from labeling their milk as rBGH-free.
the tide against rBGH use — but there is still much to be
These bills could keep the market for rBGH milk alive by
done. With labeling under attack, it’s more important
pulling the wool over consumers’ eyes. Check to see if a
than ever to send a clear message to dairy companies that
labeling bill has been introduced in your state and organize
consumers want rBGH-free milk and will choose it if it is
letter-writing and call-in campaigns to your state legisla-
properly labeled. If the dairy products you buy are not
tors. Let them know that they should preserve consumers’
labeled rBGH free, then call the dairy company, ask them
right to information about their food and preserve rBGH-
if their suppliers use the drug, and tell them that you are
free labeling!
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
In 2006, Food & Water Watch “dairy cows” engaged consumers review of existing research. Tell your members of Congress
in Washington, D.C., and elsewhere to ask Starbucks to switch that you are concerned about rBGH in the dairy supply.
to rBGH-free milk. After hearing the response from their patrons, They should bring attention to the issue through hearings
Starbucks eliminated all rBGH milk from its stores less than two and should follow the lead of Canada and the EU by in-
months later. Photo by Brendan Hoffman. structing FDA to revoke its approval of rBGH.

11
rBGH: How Artificial Hormones Damage the
Dairy Industry and Endanger Public Health

Endnotes 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.
1 Collier, Robert. “Regulation of rbST in the US.” AgBioForum, vol 3 15 Kusserow, Richard P. “Audit of issues related to the Food and
no. 2 & 3. 2000 at 156-163. Drug Administration review of bovine somatotropin.” Office of the
2 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al. Inspector General. (A-15-90-00046). February 21, 1992 at 6.
Health Canada, Drug and Health Products. “Report of the Canadian 16 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the
Veterinary Medical Association expert panel on rBST.” Available at whistle.” Business Week. September 2, 1991 at 75; Schneider, Keith.
http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_ “F.D.A. accused of improper ties in review of drug for milk cows.”
cvma-rap_acdv_tc-tm-eng.php. November 1998, section 7; Groves, The New York Times. January 12, 1990 at A21.
Martha. “Canada Rejects Hormone that Boosts Cows’ Milk Output.” 17 Schneider, Keith. “F.D.A. accused of improper ties in review of
Los Angeles Times. January 15, 1999; European Commission, drug for milk cows.” The New York Times. January 12, 1990 at
Directorate General for Health and Consumer Protection. “Report on A21.
Public Health Aspects of the Use of Bovine Somatotrophin.” Available 18 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the
at http://ec.europa.eu/food/fs/sc/scv/out19_en.html. March 1999. whistle.” Business Week. September 2, 1991 at 75. Schneider, Keith.
3 “Monsanto’s BST barely beat tomato to market.” The Chicago Sun- “F.D.A. accused of improper ties in review of drug for milk cows.”
Times. March 20, 1994 at 28. The New York Times. January 12, 1990 at A21.
4 U.S. General Accounting Office. “Comments on FDA employees al- 19 Siler, Julia Flynn. “All things right and dutiful: a vet who blew the
leged conflicts of interest in drug approval.” (B-257122). October 19, whistle.” Business Week. September 2, 1991 at 75.
1994, at 6. 20 Schneider, Keith. “F.D.A. accused of improper ties in review of drug
5 “Cow Hormone no threat to humans, panel says.” The Chicago for milk cows.” The New York Times. January 12, 1990 at A21.
Tribune. April 1, 1993 at 4. 21 See U.S. General Accounting Office. “Recombinant bovine growth
6 U.S. General Accounting Office. “Comments on FDA employees al- hormone: FDA approval should be withheld until the mastitis issue is
leged conflicts of interest in drug approval.” (B-257122). October 19, resolved.” (B-248450). August 6, 1992 at 6.
1994 at 6. 22 See U.S. General Accounting Office. “FDA strategy needed to address
7 U.S. General Accounting Office. “Recombinant bovine growth hor- animal drug residues in milk.” (B-246269). August 5, 1992.
mone: FDA approval should be withheld until the mastitis issue is 23 U.S. General Accounting Office. “Recombinant bovine growth hor-
resolved.” (B-248450). August 6, 1992 at 2. mone: FDA approval should be withheld until the mastitis issue is
8 Feder, Barnaby. “In battling for biotech, Monsanto is the leader.” resolved.” (B-248450). August 6, 1992 at 6.
The New York Times. December 24, 1993 at D1. 24 Cruzan, Susan. U.S. Department of Health and Human Services, U.S.
9 Sinclair, Ward. “Independent Study Urged Of Bovine Growth Food and Drug Administration. “FDA Response to GAO report on
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Washington Post. September 17, 1987 at A12. 25 U.S. General Accounting Office. “Recombinant bovine growth hor-
10 Gibbons, Ann. “FDA publishes bovine growth hormone data.” mone: FDA approval should be withheld until the mastitis issue is
Science Magazine. August 24, 1990 at 852. resolved.” (B-248450). August 6, 1992 at 8 and 29.
11 Gibbons, Ann. “FDA publishes bovine growth hormone data.” 26 U.S. General Accounting Office. “Comments on FDA employees al-
Science Magazine. August 24, 1990 at 852. leged conflicts of interest in drug approval.” (B-257122). October 19,
12 “FDA panel told bovine growth hormone safe.” United Press 1994 at 1.
International. March 31, 1993. 27 U.S. General Accounting Office. “Comments on FDA employees al-
13 Kusserow, Richard P. “Audit of issues related to the Food and leged conflicts of interest in drug approval.” (B-257122). October 19,
Drug Administration review of bovine somatotropin.” Office of the 1994 at 18.
Inspector General. (A-15-90-00046). February 21, 1992 at 6.

12
Food & Water Watch

28 U.S. General Accounting Office. “Comments on FDA employees al- 52 Dohoo, Ian, DesCouteaux, Luc, Leslie, Ken, Shewfelt, Wayne, et al.
leged conflicts of interest in drug approval.” (B-257122). October 19, Health Canada, Drug and Health Products. “Report of the Canadian
1994 at 19. Veterinary Medical Association Expert Panel on rBST.” Available
29 U.S. General Accounting Office. “Comments on FDA employees al- at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/
leged conflicts of interest in drug approval.” (B-257122). October 19, rep_cvma-rap_acdv_exec-somm-eng.php. November 1998; Groves,
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30 U.S. General Accounting Office. “Comments on FDA employees al- Los Angeles Times, January 15, 1999; European Commission,
leged conflicts of interest in drug approval.” (B-257122). October 19, Directorate General of Health and Consumer Protection. “Report on
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31 See U.S. General Accounting Office. “Comments on FDA employees Somatotropin.” March 1999 at 76.
alleged conflicts of interest in drug approval.” (B-257122). October 53 United States Food and Drug Administration. “Freedom of
19, 1994 at 21-22. Information summary for Posilac®.” November 1993.
32 “Interim guidance on the Voluntary Labeling of Milk and Milk 54 Smith, David, Harris, Anthony, Johnson, Judith, Silbergeld, Ellen,
Products From Cows That Have Not Been Treated With Recombinant and Morris, Glenn. “Animal antibiotic use has an early but important
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33 U.S. General Accounting Office. “Comments on FDA employees al- mensal bacteria.” Proceedings of the National Academies of Science
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34 Gladwell, Malcolm. “Biotech food products won’t require special Commonly Used to Treat Mastitis and Respiratory Burst of Bovine
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37 U.S. General Accounting Office. “Comments on FDA employees al- 57 Smith, David, Harris, Anthony, Johnson, Judith, Silbergeld, Ellen,
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43 U.S. General Accounting Office. “Comments on FDA employees al- org/cro/food/food-safety/chicken-safety/chicken-safety-1-07/
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13
rBGH: How Artificial Hormones Damage the
Dairy Industry and Endanger Public Health

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113 Dean Foods. Securities and Exchange Commission. 10-K Filing.
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