Copyright © June 2009 by Food & Water Watch. All rights reserved. This report can be viewed or downloaded at
www.foodandwaterwatch.org.
rBGH 101
How Artificial Hormones Damage the Dairy Industry
and Endanger Public Health
Introduction...................................................................................................................................................................1
Conflicts of interest?.....................................................................................................................................................3
Animal welfare..............................................................................................................................................................4
Antibiotic resistance......................................................................................................................................................5
Why rBGH? Growth Hormones and the Push to “Get Big or Get Out”.....................................................................................6
Labeling......................................................................................................................................................................................7
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
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
2
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
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
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
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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
5
rBGH: How Artificial Hormones Damage the
Dairy Industry and Endanger Public Health
were five times more likely than vegan women to have had
twins.72 The author of the study, Dr. Gary Steinman, noted
that throughout the 1990s, the rate of human twinning
increased beyond what the scientific community expected.
“The continuing increase in the twinning rate ... [may] be a
consequence of the introduction of growth-hormone treat-
ment of cows to enhance their milk and beef production,”
he speculated.73
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
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
10
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.
11
rBGH: How Artificial Hormones Damage the
Dairy Industry and Endanger Public Health
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.
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31 See U.S. General Accounting Office. “Comments on FDA employees Somatotropin.” March 1999 at 76.
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44 U.S. General Accounting Office. “Comments on FDA employees al- Huijsdensc, XW, de Neelingc, AJ, Boschc, T., van Oosteromb, RAA,
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45 See U.S. General Accounting Office. “Comments on FDA employees Press, 2009.
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46 See U.S. General Accounting Office. “Comments on FDA employees drugresistance/community/campaign-info.htm. Accessed February
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19, 1994 at 18. 62 McEwen, Scott, Black, William, and Meek, Alan. “Antibiotic Residues
47 United States Food and Drug Administration, Freedom of (bacterial inhibitory substances) in the milk of cows treated under
Information summary for Posilac®, Package Insert, November 1993. label and extra-label conditions.” Can Vet J. Vol. 33 no. 8, August
48 United States Food and Drug Administration, Freedom of 1992, at 527-534.
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14
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