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FDA, Monsanto Need To Reveal Truth About Growth Hormone

By Peter Hardin
The Capital Times
February 2, 2004

Monsanto has announced a 50 percent cutback in sales of its recombinant bovine growth hormone. The veterinary drug is trademarked and sold as Posilac.

About 22 percent of U.S. dairy cows receive Posilac injections every two weeks, to boost milk output.

What's gone wrong with Monsanto's rbGH?

This biotech cow hormone has rocked the dairy industry and consumers since the mid-1980s. The U.S. Food and Drug Administration admits the hormone has been its biggest-ever consumer food safety controversy. Monsanto's rbGH was the first major biotech food production "tool" approved by the FDA.

Three potential problem areas come to mind: human safety, animal safety and quality control.

In my opinion, the FDA's human safety oversight of rbGH has been flawed from the beginning.

In the mid-1980s, the FDA failed to require a mandatory residue test for rbGH. Yet Monsanto and government officials claim there is "no difference" in the milk from untreated and rbGH-injected cows.

To counter intense public skepticism about rbGH, the FDA published a 10-page summary of its human safety determinations in the journal Science in August 1990. Among the findings, the agency said that the rbGH in the milk of injected cows was degraded by commercial pasteurization. The sole research cited for this claim was that of a Canadian graduate student, whose master's thesis studied the feeding of rbGH-derived milk to calves (not humans). This study erroneously heated milk for 30 minutes at the 15-second pasteurization temperature.

The greatest human safety issue regarding consumption of milk from rbGH-injected cows focuses on a secondary hormone: insulin-like growth factor-one, called IGF-1.

Growth hormones (natural and synthetic) regulate bodily production of IGF-1. IGF-1 is a miraculous, blood-borne "messenger" hormone that regulates cellular growth and function. Increased growth hormone levels (natural or synthetic) mean more IGF-1-spurring metabolism in mammary tissue, bones and elsewhere.

Structurally, IGF-1 is identical for cows and humans. Some IGF-1 naturally occurs in cow's milk. Data suggest higher IGF-1 levels are found in rbGH-injected cows' milk, compared to normal milk. Thousands of research studies probing potential links between IGF-1 and cancer development have been published in scientific and medical journals.

With regard to animal safety, injections of rbGH spur dairy cow metabolism. One-third more blood is pumped through injected cows' hearts. This synthetic hormone is so powerful it kills muscle tissue at injection sites.

In early 1990, my newspaper, The Milkweed, published stolen Monsanto animal health research files. Those files showed dramatic increases in weights of many key organs and glands of treated cows, compared to control groups.

Increased IGF-1 circulating in rbGH-injected cows' milk leaves mammary tissue and bones at greater risk for health problems, according to Michael Hansen of the Consumers Union. The modern U.S. dairy cow is under many stresses, even before she may be poked with Monsanto's biotech hormone to induce greater milk output.

Two instances of rbGH quality control problems have surfaced.

In summer 1993 - just before the FDA's approval of recombinant bovine growth hormone - confidential company documents revealed nearly a ton of dry rbGH had been contaminated at the manufacturing plant in Austria.

And in 1994, Monsanto scientist Bernard Violand reported aberrant amino acid sequences - an unintended result that his article in Protein Science acknowledged researchers did not fully understand.

Making batches of recombinant hormones using E. coli as media is not like making Jell-O.

What's gone wrong with Monsanto's rbGH? Synthetic hormones used in our food-producing livestock pose risks too serious to cover up. If a serious problem exists, why has only 50 percent of rbGH sales been curtailed, instead of 100 percent? Consumers and dairy farmers deserve a complete and honest explanation of why the FDA has restricted this drug.

A perceived cover-up by the FDA and Monsanto will only invite legal challenges and worst-case rumors. Biotechnology's long-term interests are best served by full disclosure.

Peter Hardin lives near Brooklyn.
He is the editor/publisher of The Milkweed, a monthly milk pricing report.


Observations on the Supreme Court hearing of Percy Schmeiser

by E. Ann Clark, Ph.D.
Department of Plant Agriculture
University of Guelph (
February 2, 2004

(Monday, Feb. 2, 2004 -- CropChoice guest commentary) -- I am not easy to impress, but young Terry Zakreski, the lawyer representing Saskatchewan farmer Percy Schmeiser, made an argument before the Supreme Court of Canada [Jan. 20, 2004] that was nothing short of brilliant. Not only was it original, with razor-sharp logic, but the delivery was calm, focused, deliberate, and articulate.

Picture the scene. The nine Supreme Court judges, resplendent in their red robes, file in and take their places at the far end of the room. The tall, slender, pale lawyer from Saskatoon sits alone on the Appellant's (Schmeiser) side of the aisle, flanked by three lawyers for the Respondent (Monsanto) across the aisle. Behind Zakreski are 2 pairs of lawyers and a whole lot of vacant seats. The pairs represent two sets of Interveners supporting Schmeiser's position: first, a consortium of 6 NGOs (Council of Canadians, Action Group on Erosion, Technology, and Concentration, Sierra Club, National Farmers Union, Research Foundation for Science, Technology and Ecology, and the International Center for Technology Assessment), and second, the Attorney General for Ontario. Stacked up behind the Monsanto contingent are a bevy of two or three lawyers for each of the other Interveners granted permission to speak in support of Monsanto's position - the Canola Council of Canada, BIOTECanada, and the Canadian Seed Trade Association. The audience at the back of the courtroom is limited to 50 hardy souls, most of whom have braved hours of truly bone-chilling conditions on the steps of the Supreme Court to ensure a place at the proceedings.

Conduct is formalized, with the Appellant and Respondent each accorded one hour to make their case, while the five Interveners are given from 7.5 to 15 minutes each. The Judges are free to interrupt at any time to challenge the lawyers. The Appellant has 5 minutes to rebut. It is all over by 1PM, when the judges retire to deliberate.

When he rises to face the Supreme Court of Canada, Zakreski presents a three-fold argument.

1. The actual wording of Monsanto's Patent '830, entitled "Glyphosate-Resistant Plants" consists of 52 claims encompassing various aspects of the RR gene itself and the RR cells that result from inserting the gene. But most critically, Monsanto's patent makes no reference to seeds, plants, or crops. Thus, although its actual patent ends at the cell, Monsanto has chosen to commercialize its patent rights at the level of seeds, plants, and indeed, whole crop fields. Paraphrasing from Zakreski's argument, while Monsanto says that they don't own Canada, they nonetheless claim every province and territory in Canada.

This is a critical distinction, because a seed or a plant is a higher life form, and in its ground-breaking Harvard Mouse ("oncomouse") Decision last year, this very same Court had ruled that higher life forms could not be patented in Canada. Zakreski cited other evidence showing that the Patent Act was never intended to apply to seeds or plants, which instead are covered under the Plant Breeder's Rights Act.

Thus, in order to support Monsanto's patent infringement claim against Schmeiser, the Court would necessarily have to conclude that seeds and plants - higher life forms - are subject to the Patent Act, directly contravening both their own decision on the Harvard oncomouse case and the wording of the Patent Act itself. A finding against Monsanto's claim would not deny Monsanto, or indeed, the biotech industry, their lawful patent rights. But it would affirm that patent rights are as actually worded in the patent - no more, and no less.

Either way, the ruling of the Supreme Court will not affect the provisions of the Plant Breeders Rights Act, which has been and will continue to be the dominant vehicle for protecting the intellectual property rights of innovative plant breeders in Canada. Paraphrasing again from Zakreski's closing statement, it is not Schmeiser's fault that Monsanto chose to protect its intellectual property inappropriately, under the Patent Act, instead of using the Plant Breeders Rights Act as it was intended.

2. The Patent Act gives rights over the "making, constructing, and using" of an "invention and selling it to others to be used". Infringement occurs when someone makes, constructs, or uses a patented invention for sale, without the permission of the patent owner.

Yet, Schmeiser never made, constructed, used, or sold the RR gene. He grew a 1030 ac canola crop in 1998, of which some of the plants inadvertently contained the RR gene. This is the crop for which he was charged with patent infringement.

In order to use the patented RR gene, Schmeiser would have to have sprayed Roundup on his 1030 ac crop - which he did not do. The RR gene confers only one trait - tolerance to Roundup - a trait of relevance only when the herbicide Roundup is actually sprayed. Quoting from an earlier court decision, "The uncontradicted evidence of Mr. Schmeiser is that he did not spray Roundup on his 1998 canola crop" (Para. 29, Court of Appeal). Not only did Schmeiser make this statement, but he also presented to the lower court receipts showing that he had purchased his normal complement of herbicides in 1998. Monsanto presented no evidence that he had purchased or applied Roundup to the 1998 crop.

Zakreski argued that simply growing RR-contaminated plants for sale as grain - as done by Schmeiser - did not engage the utility of Patent '830", because "the gene neither caused Mr. Schmeiser's plants to grow, nor to grow differently or better. The gene added no value at time of sale." Indeed, as shown by recent market trends, the presence of GM traits actually reduces the value of Canadian canola. Zakreski also noted that the rights granted by Parliament under the Patent Act do not pertain to the simple presence or handling of an invention, but rather, to the exploitation or utility of the invention. Thus, because Schmeiser did not use the patented gene, he did not infringe on Monsanto's patent.

3. The uncontainability of GM traits, as acknowledged by Monsanto experts in lower court proceedings, ensured off-site contamination of fields not under contract to Monsanto. Aaron Mitchell, the Biotechnology manager for Monsanto Canada, stated that "Monsanto always expected that fields of its genetically modified canola would cross-pollinate with fields of regular canola" (AR Vol. IV, p.600 (20-30)). Zakreski presented numerous examples to substantiate Monsanto's expectation of uncontrollable contamination from its RR canola.

In this particular case, a local RR-canola grower testified in lower court that while hauling his grain to market past Schmeiser's fields in 1997, a tarp came loose and "acted like a cyclone" releasing considerable seed into Schmeiser's adjoining fields (AR Vol. VI. pp. 1132-5). Wind-blown swaths from adjoining RR-canola fields landing on Schmeiser land were also acknowledged by the lower court judge. Because Schmeiser saves his own seed for replanting, the contamination carried into his next year's crop - for which patent infringement was alleged. Thus, the initial sources of contamination were an inadvertent but nonetheless unavoidable result of normal farm practice.

The degree of contamination in the 1998 crop is in dispute, with Monsanto' s figures showing 95-98%, with a value for each of 27 in-field samples. Yet, the same samples, analyzed at the University of Manitoba, showed 0-68% contamination, with some samples sufficiently degraded as to be unmeasurable.

If the simple presence of RR plants in a field is enough to constitute patent infringement, then most Western Canadian farmers would be patent infringers - albeit innocent bystanders or passive recipients of unwanted and unwelcome RR genes. Accordingly, Zakreski argued that to sustain rights over their own property, farmers should be granted a waiver or implied license to allow them to save and re-use their own seed - a lawful and traditional use of agricultural property on the Schmeiser farm - regardless of contamination which they could not control anyway.

He further argued that it was wrong to award the full value of Schmeiser's crop to Monsanto simply because the gene was found on his farm, given that he had not benefitted in any way from the contamination, and indeed, could not have prevented it.

To illustrate the unworkability of awarding the full value of the crop to the owner of a patented, contaminating gene, Zakreski presented the hypothetical but entirely plausible example of a farmer whose canola was inadvertently contaminated by two different genes, perhaps from two different neighbors. Would the owner of each patented gene be entitled to the full value of the crop? In other words, would the farmer have to pay each patent owner 100% of the value of his crop?

When Zakreski resumed his seat, the atmosphere of the silent, dignified chambers was positively electric. May his arguments be as powerful and compelling to the judges of the Supreme Court of Canada as they were to me.

Corporate profile: Monsanto Behind the Scenes - Provides a detailed account of Monsanto, including overall vulnerabilities and strengths, business activities, public relations, international markets, research and chemical contamination history. As well, a section is included on campaigns and actions against Monsanto occurring across the globe.

New & Revised Monsanto Map of the World (co-published with the Research Foundation for Science, Technology and Ecology. Distributed at the World Social Forum in Mumbai, India).

Monsanto the Gene Giant; Peddling Life Sciences or Death Sciences - a report published by the Research Foundation for Science, Technology and Ecology.


GM Rice To Be Grown For Medicine

By Geoffrey Lean, Environment Editor
The Independent
February 1, 2004

GM crops specially engineered to produce drugs are to be grown commercially for the first time, The Independent on Sunday can reveal.

An American biotech company plans to start growing medicines to treat diarrhoea in modified rice this spring. Its proposals were examined last week by regulatory authorities in California, but they have no power to stop the planting.

The rice will usher in a second generation of GM crops, which are bound to polarise opinion even more than those that have already caused controversy around the world. Unlike current crops they could offer real benefits to millions of people - but they also pose far greater health risks.

Top officials at the Department for Environment, Food and Rural Affairs believe that the danger is so great that the new crops should never be grown in Britain. But Downing Street has cautiously endorsed them.

The possibilities for growing drugs in plants - dubbed "pharming" - have been researched for years, with scientists developing a wide range of vaccines and other medicines in several common foods in the laboratory. But now Ventria Bioscience, based in Sacramento, is to break new ground by planting 130 acres with two new varieties of GM rice that will produce lactoferrin and lysozyme, infection-fighting chemicals that it will market for use in oral rehydration products to treat severe diarrhoea.

It says that this could generate enough lactoferrin to treat at least 650,000 sick children, and sufficient lysozyme for 6.5 million patients. It hopes to expand production to 1,000 acres within a few years.

The company will not disclose the site that it has earmarked for the new crops because it is worried that protesters will destroy them. But its plans have already caused alarm in California's rice-growing country. Organic farmers, in particular, fear that the GM rice will contaminate their crops; the company says that there is "no risk".

On Thursday the arguments were thrashed out before a meeting of the California Rice Commission, which is drawing up a protocol of conditions under which the rice can be grown. But Tim Johnson, the commission's president, told The Independent on Sunday that neither it nor the state's agriculture secretary, to whom it reports, has the power to stop the rice being cultivated.

He said that the commission was instead concentrating on working out precautions - such as the distance the GM rice must be from conventional crops - to try to minimise risks.

The chemicals in the rice are relatively mild - they are found in mother's milk - but they are likely to pave the way for a wide range of stronger ones. Scientists, for example, have developed vaccines to treat diseases ranging from measles to hepatitis B - and antibodies to treat cancer and dental caries, provide contraceptives and prevent genital herpes - in potatoes, maize, wheat, rice, alfalfa, carrots and tomatoes.

The company says that its plants "will become 'factories' that manufacture therapeutic proteins to combat life-threatening illnesses". It adds that "plants improved through the use of biotechnology" can produce them "for innovative treatments for diseases such as cancer, HIV, heart disease, diabetes, Alzheimer's disease, kidney disease, Crohn's disease, cystic fibrosis and many others".


Legislator Delays Bill To Regulate Bio-Crops

By Aaron Porter
The Daily Sentinel
February 2, 2004

A state legislator is delaying a bill requiring the Colorado Department of Agriculture to regulate crops genetically modified to produce pharmaceutical ingredients.

Rep. Ray Rose, R-Montrose, said the state had sufficient power under existing federal rules.

State Agriculture Commissioner Don Ament also suggested a delay until the U.S. Department of Agriculture completed a comprehensive review of its own regulations on the industry, he said.

"I will continue to closely monitor the rule-making process and (the Colorado Department of Agriculture's) role in regulating any and all intended plant-made pharmaceutical applications for Colorado. We cannot put in jeopardy over three thousand corn growers in our state," Rose said.

Pharmaceutical companies are testing crops that are genetically modified to produce compounds used in making medicines. The technique could make medicines more widely available at lower costs, say proponents.

In 2003, Meristem Therapeutics received a permit to grow corn, engineered to produce lipase, on 30 acres near Holyoke. Lipase is an enzyme that is lacking in cystic-fibrosis patients. It never planted the crop.

Environmentalists and some farm groups opposed the permit, citing fears that genetic material from pharmaceutical crops might enter the food chain.

Opponents contend that food crops may be contaminated by cross-pollination or accidental seed dispersal.

Rose said last year he would oppose any further permits for crops modified to produce pharmaceutical ingredients until state regulations are in place.

A visit to Meristem facilities in France during an industry-funded trip pointed out holes in current regulations, he said. He cited a necessity for minimum safety standards and flexibility in regulating crops based on their individual traits.

A memo indicates the agriculture department has sufficient authority under existing state law to comment on permit applications referred to it by the USDA, Rose said. He also agreed with Ament's suggestion that a delay on state legislation is prudent until the department was more certain of the role states would play under federal regulations, he said.

The USDA currently regulates genetically-engineered pharmaceutical plants but refers all applications to states for comment.

Aaron Porter can be reached via e-mail at


GM Technology Fails Local Potatoes

By Gatonye Gathura
Horizon/Daily Nation
Kenya, Africa

Trials to develop a virus resistance sweet potato through biotechnology have failed.

US biotechnology, imported three years ago, has failed to improve Kenya's sweet potato. This has confirmed critic's fears that bio-engineered techniques tried elsewhere may not be replicated in Africa with similar results.

The modified potato was launched in Kenya, in 2001 by US special envoy, Dr Andrew Young, who had flown into the country for the occasion.

Investigations, on the transgenic crop, by KARI's Biotechnology Centre, say the technology has failed to produce a virus resistant strain. "There is no demonstrated advantage arising from genetic transformation using the initial gene construct," says a report by researchers, Dr Francis Nang'ayo, and Dr Ben Odhiambo.

The transgenic potato was imported from Monsanto in the US to Kenya for tests. The initial genetic engineering work was done at the Monsanto laboratories, using virus-resistant technologies.

In a nine-year study, Monsanto had developed a coat protein responsible for virus resistance, and donated it to Kari, royalty free, to use in its sweet potato improvement programme.

"The transgenic material did not quite withstand virus challenge in the field," says the report, doubting whether the gene expression was adequate or it failed to address the diversity of virus in this region or just that the gene construct was inappropriate.

Actually, the report indicates that during the trials non-transgenic crops used as control yielded much more tuber compared to the trangenics. "All lines tested were susceptible to viral attacks."

The Kari results corresponded with an earlier study released by the Third World Network Ð Africa. The study, titled "Genetically Modified Crops and Sustainable Poverty Alleviation in Sub-Saharan Africa: An Assessment of Current Evidence", by Aaron deGrassi, of the Institute of Development Studies, University of Sussex, UK, had warned that the GM sweet potato introduced in Kenya did not address the crop's major problem - weevils.

The study offered new evidence against claims of the miracle potential of genetically modified crops for dealing with famine and poverty in Africa. After examining the impact of three genetically modified crops, sweet potato, maize and Bt cotton, on poverty alleviation in Africa it concluded that biotechnology does not address the real causes of poverty and hunger in Africa.

Now Kari's research on sweet potatoes has reverted to working with improved gene constructs based on Kenyan strain of virus. This questions the suitability of wholesale importation of foreign technologies.

It was hoped that the technology would boast one of the country's most important tubers with the widest regional distribution. It seems much more needs to be done.

Dr Young while launching the technology had said, "I don't believe that we live in this world for our crops to be destroyed. We have been given knowledge for the earth to make sense."

He had then described the continent as being, on the verge of a tremendous revolution. "With biotechnology, we are going to make a green revolution in Africa."

The sweet potato project had been approved by the Kenya Biosafety Council and mock-trials initiated in Kakamega, Kisii, Muguga, Mtwapa and Embu. But the Kari researchers say all is not lost because the experiment proves that the country has the capacity to handle transgenics in the field.

"It proved that KARI and Kenya by extension had the capacity to try the suitability of sophisticated biotechnologies," says Dr Odhiambo.

Unlike the more conventional Irish potato, the tuber is not only popular among rural communities in Kenya, but also lasts much longer after traditional processing. This makes the root tuber a more ideal crop for storage for dry seasons.

The average harvest of the crop in Kenya, however, has remained low due to a number of factors, including attacks by pests and the sweet potato virus disease. The yield losses resulting from the viral diseases, according to KARI, can be as high as 80 per cent.

Kenya's average sweet potato yield stands at six metric tons per hectare less than half the world's average 14 metric tons per hectare.

Gene modification is a relatively new technique in Kenya. Other less high-tech biotech processes such as tissue culture have been widely commercialized in crops like bananas, macadamia nuts and strawberries.

The transgenic sweet potato is not the only food crop improvement projects conducted between KARI and Monsanto. Other projects include insect-resistant cotton, and maize resistant to striga - a parasitic weed responsible for destroying up to half of yields in western and coastal parts of Kenya.

KARI is the main institute of agricultural research and technology transfer, in charge of providing such appropriate technology aimed at boosting agricultural productivity and livestock production.

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