A brief history of Monsanto and U.S. government collusion
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TITLE: Biotechnology food: from the lab to a debacle
SOURCE: New York Times, USA, by Kurt Eichenwald, Gina Kolata and
DATE: January 25, 2001
Biotechnology food: from the lab to a debacle
The following article was reported by Kurt Eichenwald, Gina Kolata and
Melody Petersen and was written by Mr. Eichenwald.
In late 1986, four executives of the Monsanto Company, the leader in
agricultural biotechnology, paid a visit to Vice President George Bush at
the White House to make an unusual pitch.
Although the Reagan administration had been championing deregulation across
multiple industries, Monsanto had a different idea: the company wanted its
new technology, genetically modified food, to be governed by rules issued
in Washington - and wanted the White House to champion the idea.
"There were no products at the time," Leonard Guarraia, a former Monsanto
executive who attended the Bush meeting, recalled in a recent interview.
"But we bugged him for regulation. We told him that we have to be
Government guidelines, the executives reasoned, would reassure a public
that was growing skittish about the safety of this radical new science.
Without such controls, they feared, consumers might become so wary they
could doom the multibillion-dollar gamble that the industry was taking in
its efforts to redesign plants using genes from other organisms - including
In the weeks and months that followed, the White House complied, working
behind the scenes to help Monsanto - long a political power with deep
connections in Washington - get the regulations that it wanted.
It was an outcome that would be repeated, again and again, through three
administrations. What Monsanto wished for from Washington, Monsanto - and,
by extension, the biotechnology industry - got. If the company's strategy
demanded regulations, rules favored by the industry were adopted. And when
the company abruptly decided that it needed to throw off the regulations
and speed its foods to market, the White House quickly ushered through an
unusually generous policy of self-policing.
Even longtime Washington hands said that the control this nascent industry
exerted over its own regulatory destiny - through the Environmental
Protection Agency, the Agriculture Department and ultimately the Food and
Drug Administration - was astonishing.
"In this area, the U.S. government agencies have done exactly what big
agribusiness has asked them to do and told them to do," said Dr. Henry
Miller, a senior research fellow at the Hoover Institution, who was
responsible for biotechnology issues at the Food and Drug Administration
from 1979 to 1994.
The outcome, at least according to some fans of the technology? "Food
biotech is dead," Dr. Miller said. "The potential now is an infinitesimal
fraction of what most observers had hoped it would be."
While the verdict is surely premature, the industry is in crisis.
Genetically modified ingredients may be in more than half of America's
grocery products. But worldwide protest has been galvanized. The European
markets have banned the products and some American food producers are
backing away. A recent discovery that certain taco shells manufactured by
Kraft contained Starlink, a modified corn classified as unfit for human
consumption, prompted a sweeping recall and did grave harm to the idea that
self-regulation was sufficient. The mighty Monsanto has merged with a
How could an industry so successful in controlling its own regulations end
up in such disarray?
The answer - pieced together from confidential industry records, court
documents and government filings, as well as interviews with current and
former officials of industry, government and organizations opposing the use
of bioengineering in food - provides a stunning example of how management,
with a few miscalculations, can steer an industry headlong into disaster.
For many years, senior executives at Monsanto, the industry's undisputed
leader, believed that they faced enormous obstacles from environmental and
consumer groups opposed to the new technology. Rather than fight them, the
original Monsanto strategy was to bring in opponents as consultants, hoping
their participation would ease the foods' passage from the laboratory to
the shopping cart.
"We thought it was at least a decade-long job, to take our efforts and
present them to environmental groups and the general public, and gradually
win support for this," said Earle Harbison Jr., the president and chief
operating officer at Monsanto during the late 1980's.
But come the early 1990's, the strategy changed. A new management team took
over at Monsanto, one confident that worries about the new technology had
been thoroughly disproved by science. The go- slow approach was shelved in
favor of a strategy to erase regulatory barriers and shove past the
naysayers. The switch invigorated the opponents of biotechnology and
ultimately dismayed the industry's allies - the farmers, agricultural
universities and food companies.
"Somewhere along the line, Monsanto specifically and the industry in
general lost the recipe of how we presented our story," said Will
Carpenter, the head of the company's biotechnology strategy group until
1991. "When you put together arrogance and incompetence, you've got an
unbeatable combination. You can get blown up in any direction. And they
New Microbes Bring New Fears
In the summer of 1970, Janet E. Mertz was working at Cold Spring Harbor
Laboratory, picking up tips on animal viruses from Dr. Robert Pollack, a
professor at the private research center on Long Island and a master in the
field. One day she began to explain to Dr. Pollack the experiment she was
planning when she returned to her graduate studies in the fall at Stanford
University with her adviser, Dr. Paul Berg. They were preparing to take
genes from a monkey virus and put them into a commonly used strain of
bacteria, E. coli, as part of an effort to figure out the purposes of
different parts of a gene.
Dr. Pollack was horrified. The virus she planned to use contained genes
that could cause cancer in rodents, he reminded her. Strains of E. coli
live in human intestines. What if the viral genes created a cancer- causing
microbe that could be spread from person to person - the way unmodified E.
coli can. Dr. Pollack wanted Ms. Mertz's project halted immediately. .
"I said to Janet, ‘There's a human experiment I don't want to be part of,'
" Dr. Pollack said in a recent interview.
The resulting transcontinental shouting match between Dr. Pollack and Dr.
Berg set off a debate among biologists around the world as they
contemplated questions that seemed lifted from science fiction. Were
genetically modified bacteria superbugs? Would they be more powerful than
naturally occurring bacteria? Would scientists who wanted to study them
have to move their research to the sort of secure labs used to study
diseases like the black plague?
"The notion of being able to move genes between species was an alarming
thought," said Alexander Capron, a professor of law and medicine at the
University of Southern California in Los Angeles. "People talked about
there being species barriers - you're reorganizing nature in some way."
As researchers joined in the debate, they came to the conclusion that
strict controls were needed on such experiments until scientists understood
the implications. In 1975, the elite of the field gathered at the Asilomar
conference center in Pacific Grove, Calif. There, they recommended that all
molecular biologists refrain from doing certain research and abide by
stringent regulations for other experiments. To monitor themselves, they
set up a committee at the National Institutes of Health to review and
approve all research projects.
It took just a few years - and hundreds of experiments - before the most
urgent questions had their answers. Over and over again, scientists created
bacteria with all manner of added or deleted genes and then mixed them with
naturally occurring bacteria.
But rather than creating superbugs, the scientists found themselves
struggling to keep the engineered bacteria from dying as the more robust
naturally occurring bacteria crowded them out.
It turned out that adding almost any gene to bacteria cells only weakened
them. They needed coddling in the laboratory to survive. And the E. coli
that Ms. Mertz had wanted to use were among the feeblest of all.
By the mid-1980's, the Institutes of Health lifted its restrictions. Even
scientists like Dr. Pollack, who sounded the initial alarm, were satisfied
that the experiments were safe.
"The answer came out very clearly," he said. "Putting new genes into
bacteria did not have the unintended consequence of making the bacteria
That decision echoed through industry like the sound of a starter's pistol.
First out of the gate were the pharmaceutical companies, with a rapid
series of experiments on how the new science could be used in medicines.
Hundreds of drugs went into development, including human insulin for
diabetes, Activase for the treatment of heart attacks, Epogen for renal
disease and the hepatitis B vaccine.
"It's been huge," said Dr. David Golde, physician in chief at Memorial
Sloan-Kettering Cancer Center in New York. "It has changed human health."
The success that modifying living organisms would bring the pharmaceutical
industry quickly attracted attention from some of the nation's largest
agricultural companies, eager to extend their staid businesses into an
arena that Wall Street had endowed with such glamour.
Monsanto Takes a Soft Approach
In June 1986, Mr. Harbison took control of Monsanto's push into
biotechnology, a project snared in mystery and infighting. A 19-year
veteran of Monsanto who had recently become its president and chief
operating officer, he formed a committee to lead the charge.
"There is little more important than this task in our corporation at this
time," Mr. Harbison wrote to the 13 executives selected for the assignment.
"We recognized early on," Mr. Harbison said in a recent interview, "that
while developing lifesaving drugs might be greeted with fanfare, monkeying
around with plants and food would be greeted with skepticism." And so Mr.
Harbison drafted a plan to reach out to affected groups - from
environmentalists to farmers - to win their support.
That same month, the company's lobbying effort for regulation began to show
its first signs of success. The Environmental Protection Agency, the
Department of Agriculture and the Food and Drug Administration were given
authority over different aspects of the business, from field testing of new
ideas to the review of new foods.
In an administration committed to deregulation, the heads of some agencies
had been opposed to new rules. At an early meeting, William Ruckelshaus,
then the head of the E.P.A., expressed skepticism that his agency should
play any role in regulating field testing, according to people who
attended. That was overcome only when Monsanto executives raised the
specter of Congressional hearings about the use of biotechnology to create
crops that contain their own pesticides, these people said.
By fall, Monsanto's strategy committee was developing a plan for
introducing biotechnology to the public. A copy of a working draft, dated
Oct. 13, 1986, listed what the committee considered the major challenges:
organized opposition among environmental groups, political opportunism by
elected officials and lack of knowledge among reporters about biotechnology.
It also highlighted more complex issues, including ethical questions about
"tinkering with the human gene pool" and the lack of economic incentives to
transfer the technology to the third world, where it would probably do the
To solve political problems, the document suggested engaging elected
officials and regulators around the world, "creating support for
biotechnology at the highest U.S. policy levels," and working to gain
endorsements for the technology in the presidential platforms of both the
Republican and Democratic Parties in the 1988 election.
To deal with opponents, the document said, "Active outreach will encourage
public interest, consumer and environmental groups to develop supportive
positions on biotechnology, and serve as regular advisers to Monsanto."
Former Monsanto executives said that while they felt confident of the new
food's overall safety, they also recognized that bioengineering raised
concerns about possible allergens, unknown toxins or environmental effects.
Beyond that, there was a reasonable philosophical anxiety about human
manipulation of nature.
"If this business was going to work, one of the things we had to do was
engage in a dialogue with all of the stakeholders, including the consumer
groups and the more rational environmental organizations," said Mr.
Carpenter, who headed the biotechnology strategy group. "It wasn't Nobel
Decision on Milk Causes a Furor
Even as Monsanto was assembling its outreach strategy, other documents show
that it was making strides toward what former executives now acknowledge
was a major strategic blunder. The company was preparing to introduce to
farmers the first product from its biotechnology program: a growth hormone
produced in genetically altered bacteria. Some on the strategy committee
pushed for marketing a porcine hormone that would produce leaner and bigger
But, simply because the product was further along in development, the
company decided to go forward with a bovine growth hormone, which improves
milk production in cows - despite vociferous objections of executives who
feared that tinkering with a product consumed by children would ignite a
"It was not a wise choice to go out with that product first," Mr. Harbison
acknowledged. "It was a mistake."
Scientists who watched the events remain stunned by Monsanto's decisions.
"I don't think they really thought through the whole darn thing," Dr.
Virginia Walbot, a professor of biological sciences at Stanford University,
said of Monsanto's decision to market products that benefited farmers
rather than general consumers. "The way Thomas Edison demonstrated how
great electricity was was by providing lights for the first nighttime
baseball game. People were in awe. What if he had decided to demonstrate
the electric chair instead? And what if his second product had been the
electric cattle prod? Would we have electricity today?"
The decision touched off a furor. Jeremy Rifkin, director of the Foundation
on Economic Trends, an opponent of biotechnology, joined with family-farm
groups worried about price declines and other organizations in a national
campaign to keep the Monsanto hormone out of the marketplace. Some
supermarket chains shunned the idea; several dairy states moved to ban it.
The first step toward the shopping cart brought only bad news.
One year later, in 1987, the E.P.A. agreed to allow another company,
Advanced Genetic Sciences, to test bioengineered bacteria meant to make
plants resistant to frost. But under the agency's guidelines, it had to
declare the so-called ice-minus bacteria a new pesticide - classifying
frost as the pest.
On April 28 and May 28, strawberry and potato plants were sprayed in two
California cities. Photographs of scientists in regulation protective gear -
spacesuits with respirators - were broadcast around the world, generating
"It was surreal," said Dr. Steven Lindow, a professor at the University of
California at Berkeley, who helped develop the bacteria.
For the executives at Monsanto, these troubling experiences reinforced
their commitment to the strategy of inclusion and persuasion.
The most complex challenge came in Europe, where there was deep distrust of
the new foods, particularly among politically powerful farmers. Faced with
such resistance, Mr. Harbison said Monsanto began subtly shifting its
attention from the lucrative European market to Asia and Africa. The hope
was that the economic realities of a global agricultural marketplace would
eventually push Europe toward a more conciliatory attitude.
But by the early 1990's, company executives said, everything would change.
Mr. Harbison retired. Soon, Monsanto's strategy for biotechnology was being
overseen by Robert Shapiro, the former head of Monsanto's Nutrasweet unit,
who in 1990 had been named head of the agricultural division.
In no time, former executives said, the strategy inside the company began
to change. Mr. Shapiro demonstrated a devout sense of mission about his new
responsibilities, these executives said. He repeatedly expressed his belief
that Monsanto could help change the world by championing bioengineered
agriculture, while simultaneously turning in stellar financial results.
Eager to get going, he shelved the go-slow strategy of consultation and
review. Monsanto would now use its influence in Washington to push through
a new approach.
Mr. Carpenter, the former head of the company's biotechnology strategy
group, recalled going to a meeting with Mr. Shapiro, and cautioning that it
seemed risky to tamper with a strategic approach that had worked well for
the company in the past. But, he said, Mr. Shapiro dismissed his concerns.
"Shapiro ignored the stakeholders and almost insulted them and proceeded to
spend all of his political coin trying to deal directly with the government
on a political basis rather than an open basis," Mr. Carpenter said.
Mr. Shapiro, now the nonexecutive chairman of the Pharmacia Corporation,
which Monsanto merged with last year, declined to comment. But in an essay
published earlier this year by Washington University in St. Louis, he
acknowledged that Monsanto had suffered from some of the very faults cited
now by critics. ‘We've learned that there is often a very fine line between
scientific confidence on the one hand and corporate arrogance on the
other," he wrote. "It was natural for us to see this as a scientific issue.
We didn't listen very well to people who insisted that there were relevant
ethical, religious, cultural, social and economic issues as well."
Objections by Scientists
On May 26, 1992, the vice president, Dan Quayle, proclaimed the Bush
administration's new policy on bioengineered food.
"The reforms we announce today will speed up and simplify the process of
bringing better agricultural products, developed through biotech, to
consumers, food processors and farmers," Mr. Quayle told a crowd of
executives and reporters in the Indian Treaty Room of the Old Executive
Office Building. "We will ensure that biotech products will receive the
same oversight as other products, instead of being hampered by unnecessary
With dozens of new grocery products waiting in the wings, the new policy
strictly limited the regulatory reach of the F.D.A, which had oversight
responsibility for foods headed to market.
The announcement - a salvo in the Bush administration's "regulatory relief"
program - was in lock step with the new position of industry that science
had proved safety concerns to be baseless.
"We will not compromise safety one bit," Mr. Quayle told his audience.
In the F.D.A.'s nearby offices, not everyone was so sure.
Among them was Dr. Louis J. Pribyl, one of 17 government scientists working
on a policy for genetically engineered food. Dr. Pribyl knew from studies
that toxins could be unintentionally created when new genes were introduced
into a plant's cells. But under the new edict, the government was
dismissing that risk and any other possible risk as no different from those
of conventionally derived food. That meant biotechnology companies would
not need government approval to sell the foods they were developing.
"This is the industry's pet idea, namely that there are no unintended
effects that will raise the F.D.A.'s level of concern," Dr. Pribyl wrote in
a fiery memo to the F.D.A. scientist overseeing the policy's development.
"But time and time again, there is no data to back up their contention."
Dr. Pribyl, a microbiologist, was not alone at the agency. Dr. Gerald
Guest, director of the center of veterinary medicine, wrote that he and
other scientists at the center had concluded there was "ample scientific
justification" to require tests and a government review of each genetically
engineered food before it was sold.
Three toxicologists wrote, "The possibility of unexpected, accidental
changes in genetically engineered plants justifies a limited traditional
The scientists were displaying precisely the concerns that Monsanto
executives from the 1980's had anticipated - and indeed had considered
reasonable. But now, rather than trying to address those concerns,
Monsanto, the industry and official Washington were dismissing them as the
insignificant worries of the uninformed. Under the final F.D.A. policy that
the White House helped usher in, the new foods would be tested only if
companies did it. Labeling was ruled out as potentially misleading to the
consumer, since it might suggest that there was reason for concern.
"Monsanto forgot who their client was," said Thomas N. Urban, retired
chairman and chief executive of Pioneer Hi-Bred International, a seed
company. "If they had realized their client was the final consumer they
should have embraced labeling. They should have said, ‘We're for it.' They
should have said, ‘We insist that food be labeled.' They should have said,
‘I'm the consumer's friend here.' There was some risk. But the risk was a
hell of a lot less."
Even some who presumably benefited directly from the new policy remain
surprised that it was adopted. "How could you argue against labeling?" said
Roger Salquist, the former chief executive of Calgene, whose Flavr Savr
tomato, engineered for slower spoilage, was the first fruit of
biotechnology to reach the grocery store. "The public trust has not been
nurtured," he added.
In fact, the F.D.A. policy was just what the small band of activists
opposed to biotechnology needed to rally powerful global support to their
"That was the turning point," said Jeremy Rifkin, the author and activist
who in 1992 had already spent more than a decade trying to stop
biotechnology experiments. Immediately after Vice President Quayle
announced the F.D.A.'s new policy, Mr. Rifkin began calling for a global
moratorium on biotechnology as part of an effort that he and others named
the "pure food campaign."
He quickly began spreading the word to small activist groups around the
world that the United States had decided to let the biotechnology industry
put the foods on store shelves without tests or labels. Mr. Rifkin said
that he got support from dozens of small farming, consumer and animal
rights groups in more than 30 countries. In Europe, these small groups
helped turn the public against genetically altered foods, tearing up farm
fields and holding protests before television cameras.
If the F.D.A. had required tests and labels, Mr. Rifkin said, "it would
have been more difficult for us to mobilize the opposition."
Today, the handful of nonprofit groups that joined Mr. Rifkin's in lobbying
the F.D.A. for stronger regulation in 1992 have multiplied to 54. Those
groups, including the Sierra Club, Friends of the Earth, the Natural
Resources Defense Council, Public Citizen and the Humane Society of the
United States, signed a petition this spring demanding that the government
take genetically engineered foods off the market until they are tested and
"There is absolutely no question that the voluntary nature of the policy
was unacceptable to many," said Andrew Kimbrell, one of the early activists
to oppose biotechnology and now the executive director of the Center for
Food Safety, which filed the petition.
The F.D.A. policy has also helped organizations like Mr. Kimbrell's raise
money. In late 1998 groups opposed to biotechnology approached the hundreds
of foundations that give regularly to environmental causes and told them
about the government's decision to let the companies regulate themselves.
Since then, the foundations have given the groups several million dollars
out of concern over the policy, said Christina Desser, a lawyer in San
Francisco involved in the fund-raising effort.
There was also an about-face in the approach to dealing with overseas
markets. As the Clinton administration came to Washington, Monsanto
maintained its close ties to policy makers - particularly to trade
negotiators. For example, Mr. Shapiro was friends with Mickey Kantor, the
United States trade negotiator who would eventually be named a Monsanto
Confrontation in trade negotiations became the order of the day. Senior
administration officials publicly disparaged the concerns of European
consumers as the products of conservative minds unfamiliar with the science.
"You can't put a gun to their head," Mr. Harbison said of the toughened
trade strategy with Europe. "It just won't sell."
And it didn't. Protests erupted in Europe, and genetically modified foods
became the rallying point of a vast political opposition. Exports of the
foods slowed to a stop. With a vocal and powerful opposition growing in
both Europe and America, the perceived promise of biotechnology foods began
to slip away.
By the end of the decade, the magnitude of Monsanto's error in abandoning
its slow, velvet-glove strategy of the 1980's was apparent. Mr. Shapiro
himself acknowledged as much. In the fall of 1999, he appeared at a
conference sponsored by Greenpeace, the environmental group and major
There, while declaring his faith in biotechnology, Mr. Shapiro acknowledged
that his company was guilty of "condescension or indeed arrogance" in its
efforts to promote the new foods. But it was too late for a recovery. Soon
after that speech, with the company's stock price in the doldrums because
of its struggles with agricultural biotechnology, Monsanto itself ended its
existence as an independent company. It was taken over by Pharmacia, a New
Jersey drug company.
In recent months, biotechnology has been struggling with the consequences
of its blunders. Leading food companies like Frito-Lay and Gerber have said
they will avoid certain bioengineered food. And grain companies like Archer
Daniels Midland and Cargill have asked farmers to separate their
genetically modified foods from their traditional ones. That, in turn,
creates complex, costly and - as the Starlink fiasco shows - at times
flawed logistical requirements for farmers.
Efforts have been made by industry and government to assuage public
concerns - although critics of the technology maintain that the attempts do
not go far enough. Last week, the F.D.A. announced proposed rule changes
requiring the submission of certain information that used to be provided
voluntarily. But even supporters of the rule change say that it will make
little practical difference in the way the business works, since companies
have universally submitted all such information in the past, even under the
And the industry itself has started down a new path, with a multimillion-
dollar advertising campaign promoting genetically engineered foods as safe
products that provide enormous benefits to populations around the world -
an effort that some food industry officials say has come 10 years too late.
"For the price of what it would have cost to market a new breakfast cereal,
the biotech industry probably could have saved itself a lot of the struggle
that it is going through today," said Gene Grabowski, a spokesman with the
Grocery Manufacturers of America, a trade group.
And in recent weeks, Monsanto itself has announced plans to chart a new
course - one with striking similarity to the course abandoned in 1992 -
reviving its outside consultations with environmental, consumer and other
groups with concerns or interest in the technology.
For the corporate veterans who set the original strategy, this is scant
solace. A dream they had worked so hard to achieve had, at the very least,
been set back by years.
"You can't imagine how I have bled over this," said Mr. Carpenter, the
former head of biotechnology strategy for Monsanto. "They lost the battle
for the public trust."
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