GENTECH archive

[Index][Thread]

Monsanto Report from ECOLOGIST - The revolving door



Last summer "The Ecologist" prepared a Monsanto-centered edition but it
was pulped by the printer because of threat of libel.

I didn't see it until recently. 

See
http://www.gn.apc.org/ecologist/SeptOct/
for the whole thing except that footnotes are missing; I had started
reformatting to make the footnote refs clearer before noticing their
absence.

But I'm passing on one of the items here for educational purposes.
Cheers

MichaelP
==================
http://www.gn.apc.org/ecologist/SeptOct/

==========================
The Monsanto Files

The Ecologist September October 1998
{footnotes are missing}

Revolving Doors:
Monsanto and the Regulators

by JENNIFER FERRARA

Traditionally, key figures at the FDA in particular have either held
important positions at Monsanto, or are destined to do so in the
future. Is it surprising therefore that Monsanto gets clearance frr
its often dangerous products?

Though the evolution of genetic engineering from a laboratory science
to a method of creating commercial products happened very
fast - within a decade - the US government saw the
commercialization of biotechnology coming and deliberately chose a
path that has amounted to nonregulation. Genetic engineering broke
through natural barriers of reproduction and sped up plant and animal
breeding processes, but agribusiness corporations were wary that
burdensome regulations would hinder new discoveries and therefore the
commercial development of the technology. The federal government took
up industry's cause. Instead of establishing strict,
precautionary regulations that gave priority to public and
environmental health, the government patched together an inadequate
regulatory system that relied on risk assessment, industry science,
and corporate volunteerism.

The US was in the heat of a high-tech economic race with Japan, and,
as far as agriculture was concerned, lawmakers saw genetic engineering
as the new technology that would allow the US to maintain its position
as the world's agricultural "leader".The federal government would
erect no law that might reduce America's competitiveness in the
future world market for bioengineered products.

The first government body to establish guidelines for biotechnology
research was the National Institutes of Health (NIH) in 1976.[1] Since
the NIH is an advisory and not a regulatory body, it could formulate
guidelines, but it had no  power to enforce them. From the beginning,
the NIH guidelines relied on the scientific community's and
industry's self-regulation, starting a trend that continues
today. As corporations became more involved in genetic engineering,
NIH guidelines made accommodations for field tests and mass production
of genetically engineered organisms. In 1977 and 1978, 16 bills to
regulate genetic research were introduced in the US Congress. None was
passed, and the NIH guidelines  -  which dealt primarily with
medical and pharmaceutical research and did not take a precautionary
approach  -  remained the sole regulatory mechanism for
biotechnology research.

In the early 1980s, agribusiness corporations were developing
genetically engineered plants, animal drugs, and livestock, but no
system was in place to regulate the development, sale, or use of these
products.[2] This was the era of the deregulatory Reagan/Bush
administration, which developed the framework by which bioengineered
products, including food, are "regulated" today. Industrial profit,
not public safety, was the administration's top priority.
Government officials in the Office of Management and Budget, the
Departments of State and Commerce, and the White House Office of
Science and Technology Policy wanted to ensure that the administration
did not do anything to "stifle" the dev[3] The Bush-era
President's Council on Competitiveness, chaired by Vice-President
Dan Quayle, joined the biotechnology industry in opposing strong
regulations and close oversight by federal agencies.[4]

The result was a 1986 "biotechnology regulatory framework".[5] The
policy was founded on the corporate-generated assertion that
bioengineering was just an extension of traditional plant and animal
breeding, and that bioengineered products did not differ fundamentally
from non-engineered organisms.[6] The administration determined that
existing federal agencies could regulate bioengineered products
sufficiently and gave them overlapping regulatory authority.[7] For
instance, the Food and Drug Administration (FDA) would regulate
bio-engineered organisms in food and drugs. The United States
Department of Agriculture would regulate genetically engineered crop
plants and animals. The Environmental Protection Agency would regulate
genetically engineered organisms released into the environment for
pest control. And the NIH would look at organisms that could affect
public health. In determining that existing agencies could do the job
of regulating bioengineered products, the administration avoided
passing new, more stringent federal laws or establishing a new
regulatory agency devoted to the task.

The policy left gaping communication gaps between agencies, plenty of
regulatory ground uncovered, and confusion over who would regulate
what.[8,9] But most importantly, the regulations were founded on
the false premise that bioengineered organisms used for food and
agricultural products are no different from non-engineered,
conventional products.10 In fact, to produce genetically engineered
foods, researchers take genes from food or non-food organisms and add
them to another organism to alter its genetic makeup in ways not
possible through sexual reproduction. The process deletes essential
proteins or adds entirely new ones, and can modify genetic
characteristics in entirely unexpected ways. As long as the new genes
come from an approved food source, the government treats new or
altered genes in bioengineered foods as natural, not novel, additives.
So in most cases regulators are not required to take a precautionary
approach when evaluating new genetically engineered food products;
products are considered safe until proven otherwise.

As late as 1994, it appeared that the federal government was still
playing catch-up in establishing working biotechnology safety
regulations. The Union of Concerned Scientists (UCS), which monitors
the biotechnology industry and the federal regulatory system, was
pointing out big holes in the so-called framework." "Fundamentally, it
does not contain sufficient statutory authority to oversee all of the
products and activities entailed in genetic engineering," wrote UCS in
February 1994. "Where authority does exist, there are problems with
implementing regulations and policies." For example, a 1992 FDA policy
exempted corporations from having to test bioengineered food for
safety and get FDA approval before the foods are put on the
market.'2 Unless the corporation determined that "sufficient
safety questions exist",'3 corporations could undergo voluntary,
private "consultations" with the agency before marketing their
product.'4

It is not unusual for agribusiness corporations like Monsanto to
manipulate the limited safety regulations that exist. To establish
safety standards for new products, federal agencies rely on studies
performed by the very corporations that are trying to get their
products on the market. Studies to determine the long-term health
consequences of new products are not always required. Over the years,
many corporations have submitted fraudulent test results showing that
their products are safe, or they have simply withheld information or
studies indicating otherwise. Because the federal government protects
corporate safety studies as trade secrets, they are not available for
public scrutiny. By sheltering corporations in this way, federal
agencies hold corporations' pursuit of profits above the
public's right to good health and a safe environment.

The Regulatory Irony
Laws governing biotechnology continue to favour agribusiness and
biotechnology corporations, but as the industry has developed, the
corporate push for specific types of regulations has taken ironic
twists. The initial lack of a cautious regulatory approach enabled
small biotechnology companies to develop and market new bioengineered
products at a rapid pace. In the meantime, larger agribusiness
corporations like Monsanto and Ciba-Geigy were buying up these small
companies while developing their own expansive in-house biotechnology
research and marketing operations. During this time, Monsanto,
Ciba-Geigy, and several other agribusiness corporations came virtually
to dominate the world market for bioengineered food products,
strengthening their hold over much of the world's food supply.

>From their position at the top, Monsanto and other corporations have
actually favoured some seemingly tight regulations, but, it turns out,
only when the regulations serve corporate marketing purposes.
Regulations that require corporations to submit a plethora of costly
scientific data to regulatory agencies, for example, discourage
competition from smaller biotechnology and seed companies while giving
the public the illusion that new biotechnology products undergo
rigorous safety evaluations and are therefore safe.

In 1995, for example, Monsanto lobbied against a provision in the EPA
funding bill that would have prevented the EPA from regulating
agricultural plants bioengineered to contain the toxic bacterium
Bacillus thuringiensis (Bt). Genetically engineered foods had just hit
the market, and Monsanto was fully aware that almost any EPA
regulations for Bt plants would publicly sanction the genetically
engineered products and defuse resistance from public interest
environmental groups. Furthermore, corporations could only get their
Bt products to market if they had extensive money and resources to
jump through all the regulatory hoops. Big corporations alone can meet
data requirements and, once in the system, manipulate and pass the
EPA's safety evaluation process. With the competition out of the
way, the market is theirs.

FDA Scandals and Revolving Doors
To better understand how genetically engineered foods and the
associated safety hazards were unleashed onto the American public,
take a look at the story of the first mass-marketed bioengineered food
product, the Monsanto corporation's recombinant bovine growth
hormone (rBGH). rBGH has been linked to cancer in humans and serious
health problems in cows, including udder infections and reproductive
problems. rBGH's development and approval was rife with scandal
and protest. But the right combination of government backing,
corporate science, and heavily-funded corporate public relations
schemes paved the way for the first major release of a genetically
engineered food into the nation's food supply.

The roles played by the FDA and the Monsanto corporation in the
development, safety evaluation, approval, and marketing of rBGH led to
the exposure of the American public to the multiple hazards of
bioengineered foods. These organizations hid important information
about safety concens, masked disturbing conflicts of interest, and
stifled those who were asking the "wrong" questions and telling the
truth about rBGH.

The FDA declared rBGH-milk safe for human consumption before important
information about how rBGH-milk might affect human health was even
available.'6 When critical information about how rBGH raised the
levels of insulin-like growth factor, IGF-1, in milk'7 and the
possible link between IGF-1 and human cancer began to emerge,'8
[See Kingsnorth in this issue] the FDA was already apparently in too
deep to change its mind or ask more questions about the drug's
effect on human health. Instead, the agency relied almost exclusively
on data generated by the Monsanto corporation and highly criticized by
independent scientists to justify a decision it had made years Many
independent scientists have called for more extensive, long-term
studies, which have never been done.

In 1991, a researcher at the University of Vermont (UVM). where
Monsanto was spending nearly half a million dollars to fund test
trials of rBGH, leaked information about severe health problems
affecting rBGH-treated cows, including mastitis and deformed births)1
The scientist heading the research had already made numerous public
statements to state lawmakers and the press and released a preliminary
report indicating that rBGH-treated cows suffered no abnormal rates of
health problems compared with untreated cows.'2 The US General
Accounting Office (GAO) investigated. During the investigation, the
FDA stalled in providing the GAO with original Monsanto test data.23
and the GAO was unable to obtain critical data from UVM and Monsanto24
The GAO terminated its investigation, concerned that Monsanto had had
time to manipulate the questionable data and that any further
investigation would be Fruitless. In an effort to dissipate public
concern, UVM scientists finally released information showing
rBGH's negative effect on cow health, years after the findings
had been made."

Even FDA insiders have criticized the agency for its slack review of
the drug, but the FDA has dismissed these concerns and fired at least
one official who blew the whistle on the organisation's corrupt
drug approval process. Veterinarian Dr. Richard Burroughs reviewed
animal drug applications at the FDA's Center for Veterinary
Sciences from 1979 until he was ; fired in 1989.?6 In 1985, Burroughs
headed the FDA's review of t rBGH and remained directly involved
in the review process for almost five years. Burroughs wrote the
original protocols for animal safety studies and reviewed the data
that rBGH developers, including Monsanto, submitted as they carried
out safety studies.

A 1991 article in Eating Well magazine quotes Burroughs describing a
change in the FDA beginning in the mid-1980s. "There seemed to be a
trend in the place toward approval at any price. It went from a
university-like setting where there was independent scientific review
to an atmosphere of "approve, approve, approve."27 This is the
atmosphere in which the FDA carried out its review of rBGH. According
to Burroughs, the FDA was totally unprepared to review rBGH, the first
bioengineered animal drug to go through the FDA's approval
process; rBGH was out of the scope of most FDA employees'
knowledge. But rather than admit incompetence, the FDA "decided to
cover up inappropriate studies and decisions," and agency officials
"suppressed and manipulated data to cover up their own ignorance and
incompetence?28

Burroughs himself was faced with corporate representatives who wanted
the agency to ease strict safety testing protocols, and he saw
corporations drop sick cows from rBGH test trials and manipulate data
in other ways to make health and safety problems disappear. According
to Burroughs, the raw, untouched data stashed away behind the
agency's doors and protected as trade secrets would show
otherwise.

Burroughs challenged the agency's lenience and its changing role
from guardian of public health to protector of corporate profits. He
criticized the FDA and its handling of rBGH in n statements to
Congressional investigators, in testimony to state legislatures, and
to the press.29 Inside the FDA, he rejected a number of
corporate-sponsored safety studies as insufficient and was prevented
by his superiors from investigating data submitted by industry
revealing possible health problems caused by rBGH. Though Burroughs
had a record at the FDA showing eight straight years of good
performance, he began receiving poor performance reports, for which he
claims he was set up. Finally, in November 1989, he was fired for
"incompetence"

Not only did the FDA fail to act upon evidence that rBGH was not safe,
the agency actually promoted the Monsanto corporation's product
before and after the drug's approval. In doing so, the FDA took
on the impossible double role of regulator and promoter of
bioengineered foods. Dr. Michael Hansen of Consumers Union notes that
the FDA acted as an rBGH advocate by issuing news releases promoting
rBGH, making public statements praising the drug, and writing
promotional pieces about rBGH in the agency's publication, FDA
Consume;:

This dual role also manifested itself in other ways. In an apparent
attempt to quell public controversy over rBGH, for example, two FDA
researchers published industry and "independent" data in the journal
Science in 1990 to show that rBGH was safe for consumers)' Gerald
Guest, the director for FDA's Center for Veterinary Medicine told
Science, "We'd like to get our side of the story out, to show why
we're comfortable with the safety. We'd like for people to
know that ifs a thoughtful process. and we want it to be open and
credible

Guest was apparently doing a lot of wishful thinking. Professor Samuel
Epstein criticized the FDA for acting "as a booster or advocate for an
animal drug that hasn't yet been approved." Epstein and others
faulted the FDA for including only pieces of unpublished studies about
rBGH in the Science article. but not making the full studies available
for independent review.34

The FDA's pro-rBGH activities make more sense in light of
conflicts of interest between the FDA and the Monsanto corporation."
Michael R. Taylor, the FDA's deputy commissioner for policy,
wrote the FDA's rBGH labelling guidelines. The guidelines,
announced in February 1994, virtually prohibited dairy corporations
from making any real distinction between products produced with and
without rBGH." To keep rBGH-milk from being "stigmatized" in the
marketplace, the FDA announced that labels on non-rBGH products must
state that there is no difference between rBGH and the naturally
occurring hormone. In March 1994,

Taylor was publicly exposed as a former lawyer for the Monsanto
corporation for seven years. While working for Monsanto, Taylor had
prepared a memo for the company as to whether or not it would be
constitutional for states to erect labelling laws concerning rBGH
dairy products. In other words. Taylor helped Monsanto figure out
whether or not the corporation could sue states or companies that
wanted to tell the public that their products were free of
Monsanto's drug.

Taylor wasn't the only FDA official involved in rBGI-1 policy who
had worked for Monsanto. Margaret Miller, deputy director of the
FDA's Office of New Animal Drugs was a former Monsanto research
scientist who had worked on Monsanto's rBGH safety studies up
until 1989. Suzanne Sechen was a primary reviewer for rBGH in the
Office of New Animal Drugs between 1988 and 1990. Before coming to the
FDA. she had done research for several Monsanto-funded rBGH studies as
a graduate student at Cornell University. Her professor was one of
Monsanto's university consultants and a known rBGH promoter.
Remarkably. the GAO determined in a 1994 investigation that these
officials' former association with the Monsanto corporation did
not pose a conflict of interest. But for those concerned about the
health and environmental hazards of genetic engineering, the revolving
door between the biotechnology industry and federal regulating
agencies is a serious cause for concern.

========================


*** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material
is distributed without profit to those who have expressed a prior interest
in receiving the included information for research and educational
purposes. ***