Biotechnology Food: From the Lab to a Debacle
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Source: New York Times
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The New York Times Company
January 25, 2001
Biotechnology Food: From the Lab to a Debacle
By KURT EICHENWALD, GINA KOLATA and MELODY PETERSEN
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
regulated."
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 other species.
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
pharmaceutical company.
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
were."
Biology Debate
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
dangerous."
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.
Reaching Out
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 most good.
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
Prize thinking."
A Blunder
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 hogs.
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
national outcry.
"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 widespread alarm.
"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."
Turning Point
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
regulation."
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
toxicological study."
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
cause.
"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
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