Does Monsanto Corporation Have the Right to Keep You from Knowing the Contents of Your Food?

By Kristen Philipkoski
First published in Wired Magazine

Updates. April 3, 2007: Monsanto Inc. filed a complaint to the US Food and drug Administration, asking it to ban labels identifying products as coming from cows not injected with artificial hormones.

Dec. 24, 2003: Monsanto Inc. and Oakhurst Dairy settled Monsanto’s lawsuit out of court today. Under the agreement, Oakhurst will use labels that read, “Our Farmers´ Pledge: No Artificial Growth Hormone Used.” Its previous label did not have the word “used.” But the labels also will note that the FDA claims there is no significant difference in milk from cows treated with growth hormones.

In a prepared statement, the companies said the conditions and terms of their agreement are confidential. Company officials declined further comment.

The calls from distressed dairy farmers come nearly every day, and John Bunting does what he can to help.

A mother of 14 tells Bunting that her husband feels like a failure because he can’t provide for his family on milk sales alone. Another farmer says he had to sell one of his cows to repair a broken tractor. They know Bunting, who talks to them on a cordless phone while milking his cows, will lend a commiserative ear. He might also write about them in Milkweed, the dairy publication to which he is a contributor.

By some accounts, the past 18 months have been the worst in history for the U.S. dairy farmer. Milk prices have not increased enough to adjust for inflation in the past decade, and many family dairies have shut down. Sick cows don’t get treatment because farmers can’t afford a vet, or, worse, the vet won’t come anymore because he didn’t get paid last time.

Many small farmers place much of the blame on agribusiness giant Monsanto and a bovine drug called Posilac the company sells to increase the amount of milk a cow can produce.

Some farmers say that Posilac, also known as recombinant bovine somatotropin, only adds to an already glutted milk supply, which drives down the price paid to farmers. But Monsanto says the drug can get farmers out of a slump by helping them produce more milk.

“Producing more milk efficiently allows dairy farmers to make more money,” said Jennifer Garrett, technical services director for Monsanto’s dairy business. “The farms with the highest-producing cows are those that are making the most money. Posilac is a product that allows them to do that.”

Many dairy farmers say, however, that not using the hormone is one way they can get a competitive edge. Some milk distributors pay a premium for milk from cows not treated with rBST. Plus, even though studies show rBST is safe for humans, increasing numbers of consumers are drawn to “all-natural” products.

Farmers who don’t use rBST want to advertise that fact on their product labels. But Monsanto officials say labels like “No rBSTv” or “rBST-free” are misleading, unfair and deceptive. The company has recently sued one dairy for its labels.

Oakhurst Dairy in Maine labels its milk: “Our farmer’s pledge: no artificial hormones.” Monsanto’s lawsuit says the label implies Oakhurst’s milk is somehow better than milk from cows treated with rBST, and that unfairly harms Monsanto’s business.

A federal judge in Boston has set a trial date for Jan. 5, 2004, but denied Monsanto’s request for a hearing to argue that Oakhurst should stop its labeling immediately, pending the trial’s outcome. Monsanto isn’t seeking monetary damages; its lawyers just want Oakhurst to remove the label. Oakhurst officials say they have no intention of doing so.

“We intend to defend our right to, through our labeling, let consumers know what is and what is not used in the production of the milk they drink,” said Oakhurst President Stanley Bennet.

Approximately 17 percent of U.S. dairy operations use rBST, or 32 percent of all cows, according to the USDA– most of them large farms that house thousands of cows.

The drug is made of an isolated gene from the growth hormone that cows produce when they lactate. The gene is inserted into an E. coli bacteria to make it grow rapidly in vats. Injections of the product make the cows produce more milk each day and lactate longer. Farmers say the average increase in lactation time is about 30 days, but it can go much higher. One farmer milked a cow for 1,155 days straight. Most cows produce about 25 percent more milk than they would without injections.

Large dairy farmers like Don Bennink, owner of North Florida Holsteins in Bell, Florida, swear by rBST. He has about 3,700 cows.

“(Posilac) certainly requires a certain amount of management, but it’s been very beneficial to us,” he said, because even though the price of milk is low, he’s been able to sell more of it. “This has been a rough year for the dairy business, but on the whole I think we’re considered very successful.”

John Vrieze, who owns 2,600 cows at the Emerald and Baldwin dairies in Baldwin, Wisconsin, says rBST has even saved some cows’ lives, or at least extended them, because he can milk them longer before shipping them off to the slaughterhouse.

But many smaller farmers choose not to spend the time and $5.25 per injection to use Posilac, which must be administered every two weeks after a cow begins to lactate.

Besides the time and cost, they also forego rBST because they don’t like the side effects the hormone has on their cows. A 1999 Health Canada study found Posilac increased a cow’s risk of mastitis (udder infection) up to 25 percent, which leads to more somatic cells, or pus, in the milk.

The study also found the drug increased cow infertility by 18 percent, and lameness by up to 50 percent. Based on the data, Canadian officials did not to approve rBST.

For those same reasons, the hormone is not approved in the 15 European Union countries, Australia, New Zealand and Norway. It is approved in 19 countries including Brazil, South Africa, Pakistan and the United States.

The drug has increased the price of cattle, said Joaquin Contente, a dairy farmer and president of the California Farmers Union.

“When it came out in 1993 I predicted that this was going to make cattle prices high, because it’s something that is not very healthy for the cows themselves because it stresses them out,” Contente said.

Despite the proven side effects on cows, there is no reason to believe the hormone is harmful to humans. The FDA approved rBST in 1993. By then, various researchers had found the hormone was not biologically active in humans. In one study, scientists injected rBST directly into patients, hoping to cure dwarfism. It had no effect.

Citing this and other studies, the FDA said rBST was safe. The agency also said Monsanto was not obligated to provide a test to detect whether milk came from a cow treated with rBST.

To certify that its cows are rBST-free, Oakhurst relies on affidavits signed by farmers promising not to use the hormone on their cows. Oakhurst President Stanley Bennet thinks that’s enough assurance (“If you can’t trust a Maine dairy farmer, who can you trust?” he said), but others say a test would be a more concrete guarantee.

“You could see how (a test) could be useful,” said Susan Ruland, a spokeswoman for the Milk Industry Foundation, a section of the International Dairy Foods Association. “The irony is we have situations where there is actually no way to back up if a company (uses) a label saying ‘this is from nontreated cows.’ They’re going on the word from their farmers.”

Monsanto says it’s impossible to develop a test to determine if milk is from cows treated with rBST because the milk is exactly the same as any other milk. However, a Cornell researcher says he has the technology to do it.

Ron Gorewit patented the technology for a test in 1995. He says corporate politics have stifled his efforts to develop an FDA-approved test.

Sure, milk from rBST-treated cows may be perfectly healthy for human consumption, Gorewit said. But he also believes that savvy consumers have the right to know how their milk is produced.

“I strongly believe that people should know what they’re consuming,” Gorewit said. “Let them choose what they’re going to eat or drink.”

He has not, however, been able to raise the approximately $200,000 it would take to develop an FDA-approved version of the test.

The tenured Gorewit worked with Dale Bauman at Cornell in the early ’90s to develop rBST for Monsanto. Gorewit went on to develop a test to detect milk produced using the hormone. But his colleagues did not support his efforts, and his relationship with Bauman soured.

Bauman, who did not respond to a request to be interviewed for this story, wrote a memo to the press denouncing Gorewit’s test. Meanwhile, Monsanto officials also say they believe creating such a test is pointless.

“Even if there ever were a measurable amount of recombinant BST present in the milk, it has no biological activity in humans anyway,” Garrett said. “The milk is the same wholesome, nutritious product that it’s always been, with or with out the use of Posilac.”

Still, Gorewit stands by his work.

“A test for rBST can be developed,” he said. “The technology to do this is now available, whether Dr. Bauman wants to believe it or not.”

Scientific journals in the United States shied away from his research, Gorewit believes, for fear of irritating Monsanto. He eventually published his work on the test in a Pakistani medical journal. The study details the ability to measure the activity of a fatty-acid-binding protein in milk from cows receiving rBST.

Since no test is approved to detect a difference between milk from cows treated with hormones and any other milk, the FDA issued guidelines in 1994 stating that no dairy should claim its milk is better because it came from rBST-free cows. Monsanto officials say the Oakhurst lawsuit is based upon these guidelines.

But critics believe the FDA took its cue from Monsanto back in 1994 when Michael Taylor wrote the guidelines. Taylor came to the FDA from the law firm King & Spalding, which authored the Oakhurst lawsuit and still represents Monsanto. He went on to work for the USDA and later served for 16 months as vice president for public policy at Monsanto.

An FDA representative did not return phone calls requesting comment for this article.

Meanwhile, the appeal of using no-rBST labels is growing. Horizon, a large organic dairy producer in Boulder, Colorado, also employs “no rBST” labels, as does Berkeley Farms in California. Ben and Jerry’s ice cream, Stonyfield Farms, Whole Foods markets and Organic Valley Farms all label their non-rBST products as such.

Those four companies joined in a 1997 lawsuit against Illinois for the right to voluntarily label their products. The matter was settled out of court. They still label their milk, but they include a warning saying “the FDA has found no significant difference between milk from recombinant hormone-treated and untreated cows,” per the 1994 FDA guidelines.

On Friday, Sept. 12, the FDA warned several dairies to stop using “no hormone” labels, saying that all milk contains naturally occurring hormones and the product is therefore mislabeled.

Critics wonder whether Monsanto will also want to change kosher and organic labels. Monsanto says that’s different.

“The purpose of organic standards is to establish a set of production and processing criteria to market foods labeled as organic, not to suggest organic foods are ‘healthier,’ ‘safer’ or of ‘higher quality’ than other foods currently available on supermarket shelves,” Monsanto spokesman Lee Quarles said in an e-mail.

Oakhurst’s labels don’t specifically make such claims, but the Monsanto lawsuit says they’re implied.

“We make no claims at all as to other milk,” Bennett said. “All we state in our advertising on our trucks and on our labels is that our farmers pledge that they will not use artificial growth hormones on their cows.”

Meanwhile, Bunting believes the way to remain a dairy farmer and keep his sanity as well as the family farm is to sell milk products like yogurt and curd directly to customers rather than through stores. He will soon apply for a license from the state to do so.

“The price of milk is so ridiculously low you simply can’t wholesale your milk,” he said.

© 2003 Wired Magazine

Related Feature: Negative Free Speech for Corporations: Why Monsanto Can Prevent You from Knowing the Origins of Your Food

For those seeking more information on rGBH, ejnet.org has links to a wide array of information

By Joanne Mariner
First published by FindLaw.com, November 26, 2003

Here are some numbers to consider: 14 million, 35.9 billion, and 1.

The first is an estimate of the number of people who will die of AIDS and other treatable diseases over the course of the coming year, most of them in the poor countries of the developing world.

The second figure represents the combined 2002 profits, in dollars, of the 10 biggest pharmaceutical companies listed in Fortune magazine’s annual review of America’s largest businesses.

The third figure corresponds to the number of countries that, last week, voted against a U.N. resolution on access to drugs in global epidemics such as HIV/AIDS, tuberculosis and malaria. The resolution emphasized that the failure to deliver life-saving drugs to millions of people who are living with HIV/AIDS constitutes a global health emergency. One hundred sixty seven countries voted in favor of the resolution. The single vote against it was cast by the United States.

Sadly, these numbers are closely related. To protect their exorbitant profits, drug companies are fighting the production and distribution of cheap generic versions of patented drugs. Unable to afford the medicines that could save their lives, millions of poor people around the world die of treatable illnesses every year.

And, as the recent U.N. vote exemplifies, the drug companies have a reliable ally. Not only does the U.S. government use its considerable economic power to bully developing countries into restricting access to low-cost generics, it continues to try to change the international rules that allow such generics to be made in the first place.

Unnecessary Deaths
In their vulnerability to treatable diseases, the rich and the poor live in different worlds. Every year, millions of people in developing countries die of illnesses that they would likely have survived had they lived in Europe or the United States. A key factor in the enormous global disparities in death rates is poor peoples’ lack of access to needed drugs.

Consider the case of HIV/AIDS. An estimated 42 million people are living with HIV/AIDS worldwide, 39 million of them in the developing world. India alone has at least 4.5 million people who are HIV-positive, and possibly many more.

In Los Angeles and other affluent areas, anti-retroviral drug treatment has made AIDS a manageable disease, rather than a death sentence. However, for millions of people living with HIV in developing countries, the prospects for effective treatment are still uncertain.

Currently, only a small fraction of HIV-positive individuals in poor countries have access to anti-retroviral drugs, and the cost of treatment is too high for many marginalized communities in wealthy countries. The outpatient drug rehab in Los Angeles may provide some relief for those struggling with addiction, but the availability of treatment options for HIV in underprivileged regions remains a pressing issue.

Patent Protections and Profits
Nothing in the ingredients of anti-retroviral drug treatment makes it inherently expensive. Indeed, when a combination of generic drugs is used, treatment costs are about $600 per patient per year.

But companies that profit from drug sales prefer to keep drug costs artificially high. In the United States, the cost of anti-retroviral drugs is generally in the range of $10,000 to $15,000 per patient annually, and people with advanced cases of AIDS may pay far more. Relying on international patent protections, drug companies have been trying to maintain high drug prices globally by restricting the production and distribution of low-cost generic substitutes.

Global patent protections are tied to global rules on trade, specifically, the rules of the World Trade Organization. Although the WTO’s strict intellectual property rules carve out exceptions for national health emergencies, they still go a long way toward limiting poor peoples’ access to life-saving medicines.

And as Oxfam has shown in a paper titled “Patent Injustice,” the problem extends beyond HIV/AIDS. Brand-name drugs for a number of major diseases cost several times more than their generic equivalents. The increasing drug resistance of endemic illnesses such as tuberculosis and malaria – and the resulting need for access to new drugs – means that the WTO’s monopolistic pricing rules threaten many millions of the world’s poor.

The Brazil Model
Despite the WTO’s restrictions, some developing countries have made important steps in meeting their peoples’ drug treatment needs.

In Brazil, notably, extensive prevention efforts combined with state-funded anti-retroviral treatment have reduced AIDS-related deaths by more than half since 1996. The cornerstone of Brazil’s treatment program has been the local production of generic equivalents of brand-name anti-retroviral drugs, which has driven down the cost of treatment enormously.

But Brazil’s successes, and those of countries like it, have been hard fought. The WTO rules have been a battleground on which Brazil and others have fought a series of high-stakes skirmishes with drug companies.

Backed by one of the world’s richest and most politically influential industrial lobbies, the drug companies have enlisted the U.S. government as a loyal ally in the campaign against generics. Through the office of the U.S. Trade Representative, the United States has fought to advance the interests of the pharmaceutical industry, pressuring other governments on a bilateral basis and threatening to seek trade sanctions via the WTO.

The U.S. vote last Wednesday in the Third Committee of the U.N. General Assembly was not too surprising, given this record. Still, it was dismaying to find the United States willing to stand alone against 167 other countries – as if it were a matter of principle to oppose a resolution calling for widespread public access to the drugs necessary to combat global epidemics such as HIV/AIDS, tuberculosis and malaria.

Future Trade Agreements
The U.N. vote is, moreover, a worrisome portent for the future. At present, the U.S. Trade Representative is negotiating a number of bilateral and multilateral trade agreements, including the proposed Free Trade Area of the Americas. Given U.S. advocacy on behalf of pharmaceutical companies, interests, these agreements are likely to go beyond the WTO’s rules in protecting drug patents.

President George Bush, in a number of his most high-profile speeches, has expressed a rhetorical determination to assist in the global fight against HIV/AIDS. By allowing U.S. officials to lead the world in protecting the commercial interests of drug companies, he betrays his public commitment to this cause.

Joanne Mariner is a New York-based human rights attorney

© 2003 Joanne Mariner