Formula for Disaster: rbGH/rbST: Penthouse magazine March 1999

FORMULA FOR DISASTER
AN INVESTIGATIVE REPORT ON GENETICALLY ENGINEERED BOVINE GROWTH HORMONE IN
MILK AND CONSEQUENCES FOR YOUR HEALTH
By JEFF KAMEN
March '99 PENTHOUSE MAGAZINE

After hours of happy play with her friends and with the three huge dogs who
adore her, my high energy 18-month old daughter loves to curl up on the
living room rug with a baby bottle full of fresh milk. First, she fluffs
up a pillow, then rolls into her favorite kick-back position, and for a
moment, triumphantly hoists the bottle on high like an Olympian basking in
the glory of winning her first gold medal. Within two minutes, the lush
liquid has been drained from the bottle, the baby is full, happy, and sound
asleep. Soon after, I carry her upstairs to her crib, trailed by one of our
three, 150-pound, bright-eyed Newfoundland dogs who curls up just outside
the nursery to watch over the toddler he loves more than anything. It would
be a big mistake for an intruder to
enter our home, a fatal error to present even a hint of menace to the baby.

But it takes more than devoted guard dogs and loving parents to shield kids
from invisible threats -- like the increased risk of cancer that independent
scientists maintain may come from drinking milk from cows treated with
genetically engineered BGH (bovine growth hormone), which
the U.S. government poses no danger to consumers. In fact, if it were not
for a small collection of natural food companies, activists, and a handful
of scientists who dare to challenge current scientific gospel, you would be
in the dark on this issue and without any options to exercise when it comes
to the dairy products you put in your mouth and in the mouths of those you
love.

If the critics are correct, what's at stake could be a matter of life and
death and not only for babies. The critics say-and there is new evidence to
support them -- that consuming BGH-boosted dairy products could contribute
to your developing cancer of the prostate and colon and present the women in
your life with a heightened risk of breast cancer. And last fall Canadian
government health officials triggered a scandal when they complained to
their union that their bosses, senior regulators in Canada's version of the
U.S. Food and Drug Administration,
were pressuring them to give the green light for BGH use in Canada even
though the investigators believe it poses potential health risks to both
cows and humans.


THE BACKGROUND

In the 1980's four U.S.-based chemical companies were competing in a high
stakes race to create and market the first FDA-approved genetically
engineered veterinary drug -- Bovine Growth Hormone -- a substance that
biologically tricks cows into producing lots more milk. The winner would
seize the high ground in a battle for what was perceived as a
multibillion-dollar global markets. There had to be a big payoff; it was
costing tens of millions to develop the drug and it would cost lots more to
sell it. Corporate careers would be on the line. Winners would be
richly rewarded. Losing was unthinkable.

But in April of 1988, Monsanto, the winner in that race, seemed to be in
trouble with the FDA. In a 14-page letter evaluating the company's
application for review, the FDA slapped Monsanto for sloppy work that failed
to answer crucial questions. For example, on page 6, paragraph 8: "You have
not established a margin of safety nor have you established a no-effect
level for some of the parameters in your submission." (As you read on in
this article, remember that phrase, "no effect.")

The highly critical letter was signed by Richard Lehmann, PhD, at the time,
director of the division of production drugs at the FDA's Center for
Veterinary Medicine. His top Veterinary Medical Officer on bio-engineered
Bovine Growth Hormone was Richard Burroughs, DVM, a
Cornell University-trained animal doctor with almost 10 years in government
service. Dr. Burroughs had been in private practice and developed expertise
on dairy herds. The FDA hired him in 1979 and thought so highly of him that
the agency sent him off for advanced studies in toxicology. Then he got his
biggest assignment.

"Because I was the only one in the unit who had real dairy herd experience,
when these Bovine Growth Hormone applications began coming in, my boss
handed them to me," Dr. Burroughs told me during a recent interview.

Naively, Dr. Burroughs approached his task of testing BGH as though he were
merely doing the job of protecting the health of farm animals -- not making
decisions that could put at risk hundreds of millions of dollars of
corporate investment, to say nothing of the careers of the
executives who had spent that money. Then there were the big dairy owners
and the stockholders of the chemical companies -- they had all been told
that BGH was going to be a gold mine for them, too. And don't forget the
politicians whose hands are routinely out to both the dairy interests and
the chemical companies. Dr. Burroughs didn't have a clue and he became an
almost immediate roadblock to the fast track that all those interested
parties hoped for and expected. Without realizing it, Dr. Burroughs set
about offending all of those groups by ordering a longer, more complicated,
more detailed, and more exacting set of tests of the drug's impact on cows
than anyone in that collection of stakeholders wanted or anticipated.

One specific example: Dr. Burroughs learned that the original plan called
for a single lactation study to prove that BGH effectively triggers a boost
in milk output. But Dr. Burroughs said that wasn't adequate as a safety
test. He insisted on "doing at least a 2-year study because the test cows
have to get bred, they must have calves, and they have to survive at least a
second and third lactation. Otherwise it's not a viable product."

At first, Dr. Burroughs' bosses let him do his job as he saw fit. He was
worried that the companies hadn't done adequate testing of the drug to
determine whether it could be harmful to cows, perhaps by damaging their
immune system. "I mean, it was a totally new drug," he says. "And we
didn't know what its impact would be on cow health. We already knew about
the increased risk of mastitis -- infection of the udder -- and the
resultant likely requirement for increased use of antibiotics, but we needed
to know a whole lot more. Some of the cows in early studies of BGH by
another company wouldn't breed at all." (In 1991 the Rural Vermont Farm
Advocacy Group revealed, according to the Rutland Herald, "that an unusually
high number of...BGH-treated cows and their offspring had health problems,
including difficulty in breeding and produced
deformed or stillborn offspring.")

So Dr. Burroughs ordered FDA toxicology and immunology tests to try to
answer those questions. About a month later, on November 3, 1989, he was
summoned to a supervisor's office and fired. Immediately after the agency
threw him out, Dr. Burroughs told me, he learned that "they had quit doing
the toxicology studies I'd requested." In an interview with the Humane
Farming Association, which the HFA posted on its Website, Burroughs said, "I
was told that I was slowing down the approval process. It used to be that we
had a review process at the FDA. Now we have an approval process. I don't
think the FDA is doing good, honest reviews anymore. They've become an
extension of the drug industry."

Today Dr. Burroughs is rebuilding his private practice, but he still cannot
fathom the way he was treated by the FDA's bureaucracy. His firing,
according to an FDA personnel official, was motivated by
"performance-related" matters. When PENTHOUSE sought comment from Dr.
Lehmann on Dr. Burroughs' job performance, Lehmann refused to discuss the
case, saying, "I've been retired from FDA for five years. I did have
something to do with [Dr. Burroughs being fired] but I am not going to
discuss it."

Unencumbered by the likes of Dr. Burroughs mucking up its plans, the FDA
proceeded along the track of approval for BGH despite alarmed appeals from
organizations like Consumers' Union, publisher of Consumer Reports so many
Americans rely on to sort out the truth about product
claims. In an April 5, 1993 letter to then-FDA Commissioner Dr. David
Kessler, Consumers Union called into question a sudden change in the use of
language by the FDA:

"We are seriously concerned that, in its deliberations on whether to approve
Bovine Growth Hormone, the [FDA's] Center for Veterinary Medicine is
introducing an entirely new regulatory concept that is not authorized by the
Food, Drug, and Cosmetic Act--the concept of 'manageable risk'.

"In a discussion at the FDA's Veterinary Advisory Committee on March 31,
1993, the Committee was asked to consider whether the increased incidence of
mastitis caused by BGH use represents a 'manageable risk.' The Committee
(with the exception of its consumer representatives) then concluded that the
risks to human and animal health are 'manageable' and that BGH therefore
should go forward.

"This is the first we have heard of 'manageable risk' as a standard for
approving a veterinary drug for use in a food animal," Consumers Union said
and went to remind the FDA of the agency's own letter dated April 3, 1988,
which expressed concern to Monsanto that the company had not
demonstrated a 'no-effect' level for side effects from BGH: "You have not
established a margin of safety nor have you established a no-effect level
for some of the parameters in your submission. . .this is particularly true
for clinical entities such as mastitis . . . it is clear from the data
presented that if you seek approval of a range of 250-500mg [of BGH] in
cows/heifers you may not have even a 1x margin of safety. Under current
standards, this is unacceptable for an over-the-counter approval.

"We think it appropriate," Consumers Union continued, "that to obtain
approval of a production drug, a drug not designed to cure any known
disease, a manufacturer should be required to demonstrate no adverse side
effects at the level it is proposing for commercial use. In fact, we would
expect that [the FDA] would impose a margin of safety so that there would be
no adverse effect at five times the proposed dosage level.

"Unfortunately, it begins to appear that FDA is revising its criteria for
approval to accommodate Monsanto's needs. After apparently years of trying,
Monsanto has been unable to demonstrate a "no effect" level for BGH. The
criteria for approval have therefore been revised to be whether
BGH use represents a 'manageable risk'."

Chew on that for a moment: Can't meet the existing criteria for safety
approval? No sweat. Just get the criteria changed. Wouldn't you like to
be able to do that on your job? Consumers Union might as well have saved
its breath. The power behind BGH was not going to be denied.

Consumers Union told PENTHOUSE that the FDA in its reply attempted to
trivialize the consumer group's profound concern, saying that effect that
everything carries some risk.

I first learned of the most important facts in this story because a computer
scientist in California, who reads my reporting in PENTHOUSE on the cancer
drug hydrazine sulfate, took the time to email my editor a copy of an
excellent newsletter, Rachel's Environment and Health Weekly.
Rachel's editor, Dr. Peter Montague, had written in detail about what he and
others see as the emerging cancer threat from Posilac, Monsanto's trade name
for its bioengineered BGH. He also focused on the situation of a
husband-and-wife team of investigative reporters fired by the
Fox-owned TV station WTVT in Tampa for refusing to tell untruths or "water
down" the results of their investigation into Posilac after Monsanto
apparently intimidated the station's owners. Dr. Montague shared some of
his research documentation with me, for which I am grateful.


THE FOX AND THE SAMURAI

Last summer, Fox TV suffered the civil court version of a snap kick to the
groin when a Florida judge refused to throw out a lawsuit against Fox by the
two broadcasters fired by the company. They are Steve Wilson, among the
industry's most famous and feared investigative reporters, and
his wife, Jane Akre, another award-winning TV broadcaster. I knew Wilson
more than 15 years ago when he and I worked in competing New York City TV
newsrooms. I was often jealous of the hard-hitting, meticulously
researched, substantive pieces he put on the air. His boss back then at
WCBS-TV, Steve Cohen, now the news director at KCOP-TV in Los Angeles says,
"Wilson was and is a true samurai journalist. He cares only about the
story. He doesn't make nice with people and develop sources; he digs and
digs. Steve Wilson will use anything he can get to help him discover and
expose the truth and he is utterly relentless. Without making judgments on
the current controversy, I can tell you Wilson is not the guy to hire unless
you are ready for lots of heat. He is very much a big story reporter and
with the big ones comes big heat."

Just ask Chrysler and Ford. Wilson's investigative reports on Chrysler's
defective door latches and Ford's fire hazard ignition switches won major
awards and clearly contributed to the public safety but cost the auto makers
a pile of embarrassment and money. In doing those kinds of
stories, Wilson had to learn a lot about defending his journalism against
predictable challenges from big, powerful, angry businesses that employ
expensive and high-powered legal talent. That made him even more careful
but no less aggressive. In 1996, Wilson quit as senior investigative
reporter for the syndicated TV show Inside Edition to spend more time with
his wife and their new baby.

Then the Tampa TV station recruited Akre as a full-time anchor/investigative
reporter, and Wilson part time to produce dramatic investigations starring
Akre that would help the station build its ratings. When Akre proposed the
idea of checking into Monsanto's Bovine Growth Hormone, its use in the
sunshine state, and what that all means in terms of the public health, the
station said go for it. Akre spent months doing interviews, unearthing
documents, writing scripts with Wilson, and editing the taped pieces.

Just before the series was to begin airing, two important things happened:
WTVT's sale to Fox was finalized and Monsanto threatened to sue Fox if
Wilson and Akre went ahead with their planned story. On the last business
day prior to the scheduled airing of the reports, Monsanto's New York City
lawyer, John J. Walsh, faxed a five-page bomb to Roger Ailes, former top
Republican-party media operative and now president and chairman of Fox News.
Walsh reminded Ailes that Posilac had won FDA approval, attacked the
reporters as biased and then got down to the implied threat of legal action
against News Corporation, the Rupert Murdoch entity that owns Fox. "There
is a lot at stake in what is going on in Florida," Walsh thundered, "not
only for Monsanto, but also for Fox News and its owner. On behalf of
Monsanto, I ask that you and your Fox News colleagues consider thoroughly
what is at stake and the enormous damage that can be done by the reckless
presentation of unsupported speculation as fact and the equally reckless
publication of unsupported accusations or innuendo of fraud, deception, and
bribery in connection with something as serious as the obtaining of
approvals for a product such as [Posilac]."

Fox blinked. Maybe shuddered is a better word.

"Suddenly," said Wilson, "the series was no longer scheduled and we began an
almost nine-month-long process during which Jane and I met with lawyers and
station executives and rewrote the scripts more than 80 times! In my long
career of investigative reporting never has there been such a transparent
cave-in to prior restraint. Fox attempted to cover up the truth by firing
us and then having a newly hired, less-experienced reporter redo the series
leaving out crucial facts and reporting some of the same lies and
distortions we refused to broadcast. It wasn't just what he left out, it
was what he left in that makes his piece so egregious.

"It was," Wilson told me, "a clear-cut case not only of a news organization
surrendering rather than having to face a potentially expensive battle over
the truth in court, but also -- and Jane and I plan to so notify the Federal
Communications Commission -- an instance in which a federally licensed
broadcast station violated the law by instructing employees to report what
the licensee knew to be false."

"Absolutely not!" roared Dave Boylan, general manager of WTVT, during a
telephone interview with PENTHOUSE on October 29, 1998. For this interview
Boylan assembled his news director, chief counsel, and new investigative
reporter Nathan Lang, who strongly rejected Wilson's assault on his
re-working of the Akre-Wilson project.

"For the record," said Lang, "we left out no crucial facts. There were no
lies and no distortion, and we stand by the stories we aired -- which
altogether amounted to almost a half-hour of air time."

During the same session, WTVT news director Phil Metlin labeled Wilson and
Akre "two desperate journalists who hide behind the shield of ethics in
journalism in what is clearly a matter of a dispute with management over not
having their contracts renewed. It's a sad day for journalism."

A week before this conversation took place, these two "desperate" reporters
had received the pretigeous Ethics in Journalism Award from the national
Society of Professional Journalists!

In a 36-page document a Fox attorney mailed to the plaintiffs last August
28, Fox-owned WTVT-TV denies the claims of Wilson and Akre and asserts 19
"affirmative defenses." Fox's response to the suit claims the two
journalists produced biased, one-sided reports, turned them in late, and
failed to perform their tasks professionally. Fox claims that its only
reasons for firing the two was their "contentious, argumentative, ad
hominem, and vituperative conduct and their refusal to abide by [Fox's]'s
established policies and procedures."

"Contentious and argumentative?" Akre responded in a statement posted on the
Website she and Wilson created to tell their story after they were yanked
off the air. "Just what is the proper response when a reporter is ordered
to deliberately and knowingly lie or distort the truth in a news broadcast
to the public? Every journalist has a moral and ethical responsibility to
tell the truth as he or she knows it. And when you're using the public
airwaves to broadcast your reports, it is a legal requirement. When Fox
threatened to fire us for upholding those basic principles, we believed we
had a clear legal and moral duty to resist their directions to break the law
and violate the public trust. Steve and I are both confident the jury will
see these personal attacks for exactly what they are, efforts by a desperate
defendant who has little legitimate defense for what they've done."

Reporting on the Akre-Wilson case, the London Observer said, "Murdoch owns,
among many, many other companies, Actmedia, a PR firm. Monsanto is one of
its clients. But Akre and Wilson do not believe that they were knifed
simply to avoid upsetting one of the old brute's customers. They see the
censorship as the natural consequence of the domination of communications by
very right-wing businesses whose owners have more in common with the
perpetrators of scandals than their audience."

"We set out to tell the truth about a giant chemical company", says Wilson.
"That used to be something reporters won awards for. As we've learned the
hard way, it's something you can be fired for these days."

What Wilson and Akre wanted to report is available from their Website --
http://www.foxBGHsuit.com. From one of the more than 80 drafts of that
report, all of which were found unacceptable by Fox management, these are
some of the major points:

"When the cow gets injected with [Monsanto's] BGH, it stimulates the
production of another hormone called IGF-1. That's really the stuff that
speeds up the cow's metabolism, causing her to produce up to 30% more milk.
But some scientists like Prof. Samuel Epstein, MD of the
University of Illinois' School of Public Health in Chicago, are warning what
might be good for the farmers' bottom line may be big trouble down the line
for people drinking the milk from treated cows. Since 1989, Epstein has
warned the government, the medical community, and the public that 'there are
highly suggestive if not persuasive lines of evidence showing that
consumption of this milk poses risks of breast and colon cancer.'

"Dr. Epstein has earned three advanced degrees, including a medical degree,
written eight books, and is frequently called upon to advise Congress about
things in our environment which may cause cancer. He and others like Dr.
William von Meyer point to what they say is a growing
body of scientific evidence of a link between IGF-1 and human cancers which
would not show up for years to come.

"'We're going to save some lives if we review this now. If we allow BGH to
go on, I'm sure we're taking excessive risks with society,' said von Meyer
who has spent 30 years studying chemical products and testing their effects
on humans. 'A human drug requires two years of carcinogenic testing and
extensive birth defect testing. BGH was tested for 90 days in rats.'

"Monsanto has consistently rejected the concerns of dissenting scientists
around the world. Dr. Robert Collier, chief Monsanto BGH scientist says, 'In
fact, the FDA has commented several times on this issue after there were
concerns raised. They have publicly restated human safety confidence this
is not something knowledgeable people have concerns about.'"


PILE-UP OF NEW EVIDENCE

Only a month after the Tampa husband-and-wife reporting team was given the
boot, more frightening news about IGF-1 began breaking in peer-reviewed
scientific publications. In a January 1998 issue of the journal Science, a
team of Harvard medical researchers reported that men with elevated but
still normal levels of IGF-1 in their blood are four times more likely to
get prostate cancer than men with average IGF-1 levels.

This is a pretty tough study to ignore; it drew on a data base of 15,000
men. The authors of the report said, "Our results raise concern that the
administration of [human growth hormone] or IGF-1 over long periods as
proposed for elderly men to delay the effects of aging may increase risk of
prostate cancer." If they're right, what could giving milk from BGH-boosted
cows to male babies mean in terms of their later-life risk of prostate
cancer?

Then in May, another solid piece of medical research appeared in The Lancet,
Britain's premiere medical journal. Researchers at Brigham and Women's
Hospital and Harvard Medical School found that women under 51 with the
highest concentrations of IGF-1 in their blood ran a sevenfold increased
risk of being stricken by breast cancer. The blood used in the statistical
analysis was collected in 1989 and 1990 from 32,826 healthy nurses, 397 of
whom ultimately were diagnosed with breast cancer, and all of them had
highly elevated levels of IGF-1 both when they were healthy and when they
were sick.

On the basis of those two major research findings on IGF-1, I wrote to the
FDA asking if the agency had seen the studies and if so, did it plan to
withdraw its approval of BGH. A letter of reply dated July 14, 1998, says
"Dear Mr. Kamen, FDA is aware of the articles in Science and
Lancet [but the FDA] is not planning to reconsider its approval of
Monsanto's. . .product, Posilac. . .FDA's determination that [BGH] is safe
was recently confirmed by the World Health Organization and U.N. Food and
Agricultural Organization's Joint Expert Committee on Food
Additives."

But the man who is probably the most potent single critic of BGH, the
University of Illinois' cancer and environmental medicine expert Dr. Sam
Epstein, who first warned of a cancer threat from bgh in 1989, told me WHO's
Expert Committee functioned "more as a rubber stamp of the FDA than an
independent body, with its membership overwhelmingly reflecting the
influence of U.S. regulatory officials, dairy and chemical industry
consultants, and food and veterinary scientists. Not a single public health
expert, not a single expert on cancer or preventive medicine sits on that
committee." Epstein's new book, "The Politics of Cancer Revisited,"
documents the history of research into IGF-1 and how the government has
ignored its stunning implications.

Dr. Epstein quotes a 1992 article by a research team unaffiliated with him
and published in the journal Breast Cancer Research and Treatment. The
authors reported that the very effective breast cancer drug Tamoxifen works
by reducing blood IGF-1 levels. And contrary to the assertions of Monsanto
and the FDA that the IGF-1 produced by injection of Posilac doesn't get
passed on to consumers of dairy products, Epstein says there is now
convincing evidence that it does. Also contrary to current official
science, Epstein reports IGF-1 is not destroyed by acid
in the stomach and in fact is protected from digestion by casein, a milk
protein. Rather it is passed along quite intact into your blood stream.

And the FDA? See no evil, hear no evil, speak no evil of Monsanto. The
company has steadfastly refused to make public the results of its rat
studies which it says support the claim that the drug is harmless. Epstein,
however, says, "The published summary of those studies--reported by the FDA
in 1990--showed that even low levels of IGF-1 administered to rats for short
periods of time induced powerful growth-stimulating effects--contrary to the
misrepresentations of Monsanto and the FDA. This is consistent with my
prior, public warnings that BGH-produced milk could lead to dangerous
premature growth in infants quite apart from future cancer risks."

Not that it will surprise you, but Dr. Epstein is routinely put down by
members of the medical establishment as "a gadfly." However his credentials
are impeccable and his work speaks for itself: eight books and hundreds of
articles, most of them published in peer-reviewed scientific journals.

In the Introduction to Epstein's new book, Congressman John Conyers, Jr., a
pioneer in environmental and public health legislation for the past 30
years, says Dr. Epstein truly understands the cancer crisis in America and
we should all "heed his clarion call" to prevention.


AND NOW A WORD FROM OUR SPONSOR

Let's take a quick, refreshing break from all this talk of deception and
disease. In fact, let's have a nice, cool, drink of milk. Maybe we can
join Health and Human Services Secretary Donna Shalala, Baltimore Orioles
iron man Cal Ripken Jr., and that former "Baywatch" honey Yasmine
Bleeth--all of whom posed for full-page "milk mustache" ads. After all,
what could be wrong with milk?

The sheer power of the Dairy Council's long-running campaign is impressive,
but there are some naysayers. Newman's Own ice cream, Ben and Jerry's,
Fresh Fields Whole Foods, and a number of local dairies now advertise their
opposition to BGH and offer products that don't contain milk from treated
cows.


SCANDAL IN CANADA

Last fall, only days before the deadline for this article, a scandal of
major proportions began to break in Canada. Six Health Canada scientists
filed grievances before the Public Service Staff Relations Board, painting
apicture of corruption around their government's review of Monsanto's BGH
and other drugs that promise to yield huge profits if approved.

They said their supervisor in Health Canada, Canada's version of the FDA,
had pressured them to quickly approve BGH, and one scientist testified
before the board that there newly appointed director had warned that if they
persisted in their slow, meticulous evaluation of drugs, he would transfer
them to another department of government, where "they would never be heard
of again." The pressure to quickly approve drugs was attributed to the
powerful lobbying by industry of Health Canada officials.

At the same time, Sierra Club Canada made public documents that Health
Canada apparently had kept from the Canadian Senate committee that is
currently investigating BGH's safety for humans and animals. The documents
reveal that Monsanto's claim--supported by the FDA--that the 90-day rat
study demonstrated no negative health effects from BGH is not true. The
suppressed documents reveal that 20-30 per cent of the rats fed the highest
doses of BGH produced antibodies to the drugs. Some rats also developed
cysts of the thyroid and early signs of harm to the prostate-all strong
warning signals that more investigation must be done.

In their scathing critique of Health Canada's early report on Posilac, an
internal review team of scientists said the initial reviewer had accepted
"the assertion by the manufacturer that [BGH] does not cause cancer in man
or animals without providing a rationale. . .There are reports on file that
Monsanto pursued aggressive marketing tactics, compensated farmers whose
veterinary bills escalated due to increased side effects associated with the
use of [BGH], and covered up negative trial results. All four [original]
U.S. manufacturers refused to disclose the lists of their research grants to
US universities. . .

"The fundamental mandate of the Human Safety requirements of the Food and
Drugs Act and Regulations toward any veterinary drug prescriptions for
food-producing animals is to enlist each and every associated risk to human
health and thereby limit its real and potential dangers to both society and
the individuals within. This does not appear to have properly been followed
toward the risk assessment of [BGH]. . .

"The only short-term toxicology study for three months in rats, was
improperly reported to conclude that BGH was not and could not be absorbed
into the bloodstream. The usually required long-term toxicology studies to
ascertain human safety were not conducted. Hence, such possibilities and
potential as sterility, infertility, birth defects, cancer and immunological
derangement's were not addressed. Virtually no attention appears to be
directed toward a critically anticipated increase in [BGH-related] infective
mastitis in dairy cows and also the
concomitantly expected increase in antibiotic therapy and antibiotic
resistance in the farm-borne pathogens of humans. "

Embarrassed by that internal review, Canada's Health Minister sent the whole
BGH issue to a pair of panels--one for human health and one for animal
health. However, it was quickly learned that one of the "independent"
experts had been a paid consultant to Monsanto. Another expert's wife was
employed by Monsanto's wholly-owned subsidiary, Searle Canada, until a few
months before the panel was formed. And critics called the animal health
panel's objectivity into question because the panel was operating through
the Canadian Veterinary Medical Association, which had publicly endorsed
BGH. The association's statement on BGH was pulled from its Website days
after the senators questioned it.

In Vermont where consumer activists have led the fight against genetically
engineered BGH, the Vermont Public Interest Research Group has delivered to
their state's members of Congress copies of the documents unearthed by the
Canadian investigators. The activists want Monsanto's FDA license to sell
BGH pulled until the whole affair can be fully investigated based on the
newly revealed data. But Monsanto's chief BGH spokesperson Gary Barton
insists, "The FDA had this data all along," and issued its 1993 finding that
BGH is harmless after reviewing that data.

What now? For its part, FDA has begun to run for cover. "We do not have
data from the study," FDA spokesperson John Scheid told Vermont's Rutland
Herald. Scheid said the FDA had relied on a summary of the data provided by
Monsanto.

"That is both astonishing and, if true, appalling," says Consumers Union
research scientist Dr. Michael Hansen. "How could the FDA have relied on a
summary from a manufacturer with a billion-dollar interest in getting a
product approved for market? What other summaries instead of actual data
have been the basis for crucial decisions by the FDA? And finally, is the
milk from BGH-treated cows safe? The painful but obvious fact is that we do
not have reliable answers to these questions and we must.

"Consumers Union now urges Congress to fully investigate this matter
including ordering an independent analysis of Monsanto's 90-day rat feeding
study and meeting with the Canadian scientists who produced the important,
new information about evidence of apparent toxicity."

If U.S. lawmakers fail to take that kind of action, it will be blatant
evidence that Congress' soul has been sold to the dairy and chemical
industries. Stay tuned. The Akre-Wilson case against Fox is scheduled to
begin in Tampa very soon.

While we wait for the results of all of the above, my wife and I have
decided to give our baby dairy products from non-BGH sources only, and we
are treating ourselves with the same respect. Untreated milk, cheese, and
yogurt are becoming available almost everywhere in the country. Drs.
Burroughs and Epstein and others who seem to know what they're talking about
highly recommend this course of action. . .Or you can trust the FDA.
# # # (c) 1999 General Media
Communications, Inc.