By Angus Durran, Safe-Food Coalition of South Africa
The seriousness of the issues at stake regarding the extremely controversial genetic engineering technology (GE) now being applied to food production and agriculture is a top priority concern for environmentalists and the South African public at large.
The biotechnology industry makes misleading claims that genetic engineering has totally predictable effects or is simply an extension of traditional cross breeding. These and other claims are being vigorously refuted by leading scientists around the world and also being successfully challenged in the US and Europe.
Alarmingly in South Africa the government has dismissed legitimate public concerns with bland assurances of safety, which are not scientifically substantiated. In 1999 Biowatch environmental group published a legal report which concluded that the government is not yet in a position to effectively regulate the industry or properly assess the risks. Profits of companies such as Monsanto are clearly being put before human health and environmental integrity.
In South Africa a leading grocery store, Woolworths, has taken a decision to go GE free and others may follow as consumer resistance mounts. As the demand for GE free products grows in Europe and other countries, exporters are keen to meet this demand by sourcing GE free crops.
FOR FURTHER INFORMATION ON GE FREE CERTIFICATION CONTACT A. DURRAN +27 (0)11 318 1399 or firstname.lastname@example.org
Thank you for agreeing to be involved in the public debate on the evening of 1 August 2000, at Gallagher Estates, Midrand. Please find attached the final programme for the symposium on Food Biotechnology. As one of the participants, you will not need to register. However, I will send you registration forms to circulate amongst your colleagues. Please confirm via e-mail that you will be available.
Dr Jocelyn Webster
Executive Director: AfricaBio
Tel: 012 667 2689 Fax: 012 667 1920 Mobile: 082 466 6929
Food Biotechnology - Facts, Fiction And The Future
One Day Symposium
[at Gallagher Estates on 1st August 2000]
Do you need to know more about food biotechnology or GM foods? Hear the truth from the experts. This one-day symposium aims to explore global, African and South African perspectives for food biotechnology with consumer, professional and industry participation. The symposium programme will include key international speakers and highlight issues such as food biotechnology benefits, concerns, regulations and their effects on suppliers and consumers. The symposium will conclude in the evening with a public debate on Food Biotechnology: the facts, fiction and the future.
|8:15 - 9:00||Registration.|
|9:00 - 9:15||Welcome and introduction - Professor Jennifer Thomson, UCT (University of Cape Town).|
|9:15 - 9:45||Keynote address - Global perspectives on food and agricultural biotechnology and biodiversity - Dr John Kilama, President Global BioDiversity Institute, Inc., United States of America.|
|9:45 - 10:05||The UK as a case study in the food biotechnology debate - Professor Bevan Moseley, member of EU Scientific Committee for Food and Chairman of its Novel Foods Working Group.|
|10:05 - 10:20||Consumer concerns: International and South African - Mrs Dianne Terblanche, Consumer Institute South Africa.|
|10:20 - 10:35||Questions and Answers.|
|10:35 - 11:00||Refreshments.|
|11:00 - 11:20||Case study: USA versus developing countries and their needs - Professor Channapatna Prakash, Tuskegee University, USA.|
|11:20 - 11:40||The impact of food and agricultural biotechnology on Africa - Dr Florence Wambugu, ISAAA.|
|11:40 - 12:00||South African government's approach to food and agricultural biotechnology - National Department of Agriculture.|
|12:00 - 12:20||Environmental concerns in South Africa - Earthlife Africa or Biowatch SA.|
|12:20 - 12:40||Legislation protecting the environment - National Department of Environmental Affairs.|
|12:40 - 12:55||Questions and Answers.|
|12:55 - 1:05||Issues to be addressed in South Africa and the region - summarised by Professor Jennifer Thomson.|
|1:05 - 1:45||Lunch.|
|1:45 - 2:30||Special Event.|
|2:30 - 2:45||Nutritional aspects of food biotechnology - Dr Ingrid van Heerden, Nutrition Consultant and Scientific Editor.|
|2:45 - 3:00||Health aspects of food biotechnology - where food and health merge - Professor Alan Smith, Head of Virology, University Natal Medical School.|
|3:00 - 3:15||Questions and Answers.|
|3:15 - 3:30||Refreshments.|
|3:30 - 3:45||Current status of labeling in South Africa - National Department of Health.|
|3:45 - 4:00||International labeling status - Professor Bevan Moseley.|
|4:00 - 4:15||Questions and Answers.|
|4:15 - 4:30||Biotechnology information, training and education - AfricaBio.|
|4:30 - 4:45||Niche market opportunities in food biotechnology - Ms Jane Badham, Dietician and Food Consultant.|
|4:45 - 5:00||Trade barrier issues related to the technology - Dr Wynand van der Walt - SANSOR.|
|5:00 - 5:15||Questions and Answers.|
|5:15 - 5:45||Will the future be based on a Bio Economy? - Mr Francois Meyer, Management of Technology, Transnet.|
|5:45 - 6:00||Summary and the way forward - Professor Jennifer Thomson.|
|6:00 - 7:30||Cocktail party and exhibits.|
|7:30 - 9:30||Public debate. (Only here the GE opposition has a voice after all the symposium participants are exhausted or drunk!)|
The attached March '99 US magazine article outlines several reasons for concern over milk from SA cows treated with the same genetically engineered hormone investigated in this article (called rBGH in the USA and rBst here).
Please circulate this information widely and raise your concerns:
For further info on rBst in South Africa, email email@example.com or firstname.lastname@example.org
Editor's note: In Sth Africa this same substance known as Recombinent Bovine Somatotropin (rBst )- has been used since 1988.
By JEFF KAMEN, March '99 PENTHOUSE MAGAZINE © 1999 General Media Communications, Inc.
An Investigative Report By Jeff Kamen
on Genetically Engineered Bovine Growth Hormone in Milk and Consequences for Your Health
rBGH all over the U.S. government poses no danger to consumers
The Fox And The Samurai
Pile-up Of New Evidence
And Now A Word From Our Sponsor
Scandal In Canada
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.
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 market. 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 asked Dr. Lehmann to comment 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 read 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.
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 prestigious 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.'"
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 Jan 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'sHospital 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 statistic 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 The 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."
Editor's note: In August 1999, Codex Alimentarius, the U.N. Food Safety Agency representing over 100 nations worldwide, ruled unanimously in favour of the 1993 European moratorium on Monsanto's genetically engineered milk hormone. Archive: http://www.gene.ch
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.
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.
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 a picture 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 their 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 list 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 for 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 derangements 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.
© 1999 General Media Communications, Inc.
By JEFF KAMEN, March '99 PENTHOUSE MAGAZINE
"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector,"
THE LANCET, April 2000
"When a butterfly flaps its wings in Africa, it can cause a hurricane in New York."
MAHARISHI INTERNATIONAL COUNCIL
OF NATURAL LAW PARTIES|
Markt 1 • 6063 AC Vlodrop • The Netherlands
Tel.: +31-475-404111 • Fax: +31-475-403642
30 June 2000
American public interest attorney Steven M. Druker, J.D., travelled for two months through 30 European cities to explain to the media and the public how internal files of the U.S. Food and Drug Administration (FDA) reveal it has been deceiving the world about the hazards of genetically engineered (GE) foods for almost a decade. He visited Belgium, France, Germany, Hungary, Denmark, Norway, Israel, Italy, Ireland, Finland, Sweden, and Latvia - some countries more than once.
Mr Druker obtained copies of the FDA files (over 44,000 pages) by bringing a lawsuit against the FDA in May 1998 to obtain adequate safety testing and labelling of all GE foods. He is the executive director of the Alliance for Bio-Integrity, a non-profit organisation that is leading the lawsuit. In organising the suit, he assembled an unprecedented coalition of eminent life scientists and leaders of society to sign on.
During this Natural Law Party sponsored tour Dr Druker met with scientists, media, political parties, policy makers, environment protection associations, and the public. Everyone he has met was impressed by the erudition and great courage Dr Druker showed in challenging the governments over their lax stand toward the almost criminal carelessness with which the American Food and Drugs Administration approved the sale of genetically engineered foods.
Dr Druker started his tour in Brussels where he met with several representatives of European Union. In France, the tour led to the first great success when Dr Druker held a press conference directly in the building of the European Parliament in Strasbourg. The meeting was co-sponsored by several Members of the European Parliament of the Green Party from Germany. Among others, Dr Druker met also with Caroline Jackson, the Chairman of the EU Committee on the Environment, Public Health and Consumer Policy.
The tour continued with press conferences in three German cities, Berlin, Bonn, and Munich. Dr Druker together with Dr Reinhard Borowitz, Secretary General of the Maharishi International Council of Natural Law Parties that organised this European tour, met with a number of politicians and experts. Several meetings were organised with members of parliament of different parties and their scientific advisors. After the meetings some parties offered a cooperation with Dr Druker and the Natural Law Party.
Presentations were also made in the ministries of agriculture and health. Dr Druker later remarked, he had the impression that in the ministry of agriculture, "the officials were utterly surprised and seemed to be ignorant about the facts regarding the insufficient testing standards of the FDA." At the Munich press conference five press representatives were breathlessly captured by the facts presented and at the end a local parliament member immediately and publicly offered cooperation with the Natural Law Party and Dr Druker. The success of the visit in Germany is documented by many excellent newspaper articles and radio interviews. The leading weekly political magazine "Focus" published a one-page interview, and the well-respected "Süddeutsche Zeitung" titled its in-depth coverage with "All gentech food is illegal".
In Hungary, Dr Druker met with professors, leaders of governmental as well as independent organisations and the press. The head of the Central Food Safety Research Agency, Dr Peter Biacs, admitted that the concept of 'substantial equivalence' is no longer believed to be true. Everywhere, Dr Druker met with openness and appreciation.
In Denmark, he lectured at two agricultural universities, gave several press interviews, and met with Parliamentary Committee for Food and Agriculture.
In Norway, the national press covered in two articles the public lecture Dr Druker gave at the university together with Prof. Traavik, an Norwegian expert on GMO. There was also a meeting with one of the biggest opposition parties after which that party expressed the wish to cooperate with the Natural Law Party. Dr Druker also met with the representatives and experts of the ministry of agriculture.
One of the highlights of Dr Druker's tour was the visit in Israel. As soon as he arrived at the Tel Aviv airport the media focussed on him and did not let go throughout his visit - interviews, TV and radio recordings were made almost daily. Many excellent articles were published, e.g. The Jerusalem Post introduced its in-depth article with "An American Jewish lawyer is campaigning against what he sees as a threat to human existence - genetically modified food...", the prime time TV News has shown an interview, and two radio interviews were broadcast. Dr Druker met the chief scientist of the ministry of agriculture who was very interested and impressed. Dr Druker also addressed the Global Assembly on Maharishi's Vedic Science held in Jerusalem from 27 April to 5 May at the Crowne Plaza Hotel.
In Italy, Dr Druker gave three press conferences - in Rome, in Catania, and in Milan. Especially, the Milan lecture was very successful: more than 100 people including the media squeezed into the lecture hall resulting in articles, radio and TV interviews, and an offer by the Green Party to organise a big conference on GMO with Dr Druker as one of the main speakers.
In Ireland, Dr Druker met with the head of the Food Safety Committee and his scientific advisors. Several newspaper articles appeared, and a long interview during the most popular radio show of the country was broadcast.
The visit in Finland started with a big press conference where the most important media of the country were present resulting in several newspaper articles and TV interviews. The public lecture was attended by over 100 persons including scientists and activists of different public interest group. The lecture ended with an open discussion during which a coalition against GMO was founded by several different organisations including the Natural Law Party. The television reported about Dr Druker's 30-minutes-meeting with the Minister of Public Health and broadcast a ten-minutes interview.
Dr Druker's visit to Sweden was another highlight of the tour. He met with officials of the Swedish Farmers Association and Swedish Consumer Organisation. Dr Druker also met with several parties' representatives and spoke at a public meeting together with leaders of political parties represented in the parliament that openly oppose GMO. He visited several ministries and spoke to the Swedish Food Administration. At the press conference were three TV stations, whose news programmes cover more than half of the Swedish population, and five newspapers represented. All the major media reported on Dr Druker's visit and the message was clear: "Scientists want to stop Gentech food" was one of the headlines.
The last stop of the tour was Latvia where Dr Druker held an extremely successful press conference and met a number of professors of the Riga university.
The entire tour was a great success and a big step forward in the campaign of the Natural Law Party to ban genetically engineered food products in all countries worldwide. Dr Druker was able to alert large parts of the European public about the great dangers of these foods to human health and the environment.
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Hi NON-Genetically-Manipulated earthling!!
Karen Kallmann, SAFeAGE co-ordinator (South African Freeze Alliance on Genetic Engineering) is up from Capetown circulating the draft of the document that will be presented to government and seeking letters of endorsement from as many groups and individuals as possible in support of the call for a 5 year freeze on all GMOs in South Africa while INDEPENDENT safety assessments are carried out.
Before she returns, it'd be great if you could join us at my place - 73 Eighth STREET (nearest intersection is 2nd AVE) Parkhurst for a fun get-together/breakfast at 8.30 tomorrow Saturday 1st July. (Sorry its short notice, but I just found out Karen had that timeslot free)
We're brainstorming ideas for the (late July) launch - with a great bunch of people I'd love you to meet, so hope you can make it.
Please call me ASAP today at our home tel/fax/voicemail (011) 788 8083
to let me know so I can go get sufficient GE-free breakfast goodies!!