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MILK CONTROVERSY SPILLS INTO CANADA
In late 1993, the U.S. Food and Drug Administration (FDA) gave permission for Monsanto corporation to market rBGH, a genetically-engineered hormone that is injected into dairy cows to make them produce more milk.[1] In 1990, FDA had declared rBGH (recombinant bovine growth hormone), "safe for human consumption."[2]
Now the scientific validity of FDA's 1993 safety decision is being challenged by Canadian government scientists. Consumer's Union (publisher of CONSUMER REPORTS magazine) and other U.S. consumer groups have called for a Congressional investigation into FDA's 1993 decision to approve rBGH.[3]
Today tens of thousands of U.S. dairy cows are injected with rBGH each week, and virtually the entire U.S. citizenry is exposed to milk from rBGH-treated cows through milk, cream, cheese, yogurt, frozen yogurt, buttermilk, cream cheese, ice cream, iced milk, and baked goods. No other country besides the U.S. has approved rBGH for use within its borders, though Monsanto has sought approval in Australia, New Zealand, the European Union and Canada.
In 1990, in SCIENCE magazine, FDA published a justification for its conclusion that milk from rBGH-treated cows was "safe for human consumption."[2] Such a public justification of a pending FDA decision is highly unusual, perhaps indicating the politically charged nature of FDA's decision to allow Monsanto to treat many of the nation's milk cows with a genetically-engineered hormone.
FDA's 1990 SCIENCE article offered seven tables of data to support its conclusion that rBGH is safe. The first two tables of data were taken from an unpublished Monsanto study of rats fed rBGH in high doses for 90 days.[4] In SCIENCE, FDA said the 90-day rat feeding study showed that rBGH "is not orally active in rats"[2,pg.875] and concluded that, "No oral activity was found when rBGH was administered to rats at exaggerated doses."[2,pg.883]
However, a recently-released Canadian government report indicates that the findings of Monsanto's 90-day rat feeding study were misreported by FDA in SCIENCE in 1990.[5] The Canadian report says that 20% to 30% of the rats fed rBGH in high doses developed primary antibody responses to rBGH, indicating that rBGH was absorbed into their blood. An antibody response is evidence that the immune system has detected, and responded to, a substance entering the body. Furthermore, cysts reportedly developed on the thyroids of the male rats and some increased infiltration of the prostate gland occurred. Despite these results, FDA reported in SCIENCE that there were "no... clinical findings" in the Monsanto rat study.[2,pg.878] The Canadian government report concludes flatly that "the 3-month rat study did show a physiological response."[5,pg.29]
One FDA official told the Associated Press this month that FDA never examined the raw data from Monsanto's rat feeding study but based its 1993 safety conclusion only on a summary of the study provided by Monsanto. John Scheid, of FDA's Center for Veterinary Medicine, told AP reporter Frederick Bever, "We do not have the data from that study."[6] Scheid said FDA had relied on a summary of the study provided by Monsanto. For the past two days, FDA officials have refused to return phone calls from REHW seeking comment. Drawing conclusions from a summary of a scientific study would be equivalent to describing the contents of a book by reading an author's summary of the book, instead of reading the book itself.
Furthermore, relying on a summary of a study, rather than on detailed data from the study, would violate FDA's published procedures. In its 1990 SCIENCE article, FDA said that "the FDA requires the pharmaceutical companies to submit all studies they conducted on their products" and said, "The companies also submit the raw data from all safety studies that will form the basis of the approval of the product;...."[2,pg.876] Furthermore, FDA explained that, "If the initial toxicity study demonstrates that the protein [such as rBGH] is indeed orally active, additional testing may be required."[2,pg.876] Thus if FDA had known in 1990 that Monsanto's rat feeding study had indicated that rBGH was orally active in rats, additional testing could have been required before a decision was made to approve or disapprove the genetically-engineered drug.
Monsanto's application to market rBGH in Canada has reportedly created political pressures on government scientists there to sidestep normal safety protocols.
** Canadian government scientists say that the Canadian government has failed to require follow-up studies that seem to be called for by the findings of the Monsanto rat-feeding study. In their report released earlier this month, they say, "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."[6]
** The scientists who wrote the report testified before an inquiry board earlier this month that they have been pressured by higher-ups to alter the content of their report, which has now been published on the internet at www.nfu.ca/nfu/Gapsreport.html.
The purpose of the Canadian report was to identify data gaps, and procedural gaps, in the handling of Monsanto's application to market rBGH in Canada.
** Two of the report's authors, and four other Canadian government scientists, testified that they have been threatened with transfers to other jobs where "they would never be heard of again" if they did not speed up approval of Monsanto's rBGH product in Canada, despite the absence of long-term data showing the product is safe for humans. Monsanto's application to market rBGH in Canada has been pending since 1990. According to the TORONTO STAR, "The scientists contend managers in Health Canada [the Canadian equivalent of FDA] are more concerned about pleasing the companies that submit the drug applications and are paying for their approval than they are about protecting health."[7] The Canadian scientists have been forbidden to speak to the press about their concerns, but they testified last month before a government board of inquiry.
** The same rat-feeding study that has raised such controversy in the U.S. has also proven controversial in Canada. A Canadian legislator, Mira Spivak, whose committee is investigating the approval process for rBGH in Canada, says Canadian health officials provided her staff with a copy of the Monsanto study in which the information about the potentially troubling effects of rBGH on rats was "blocked out."[8]
** The Canadian government report, which is critical of the rBGH review process in both Canada and the U.S., will be sent on to a panel of experts (six members from the Royal College of Physicians and Surgeons and six from the Canadian Veterinary Medical Association) for a "completely objective and arm's length review." However, the TORONTO STAR has reported that one of the physicians reviewing the report, Rejeanne Gougeon, served as a consultant to Monsanto from 1993 until May, 1998. In 1994 Gougeon published a paper recommending that the Canadian government approve rBGH. The paper was supported with a grant from a lobbying group that Monsanto helps finance, the STAR said. Gougeon told the STAR that she had never promoted rBGH, but that in the past Monsanto had paid her to give talks to consumers about genetic engineering "in a friendly context."[9]
** The Canadian government report (pg. 26) says that levels of IGF-I (insulin-like growth factor-1) are elevated in the milk produced by rBGH-treated cows. IGF-I is identical in cows and in humans and, as the name implies, it promotes growth. The Canadian report notes that U.S. FDA acknowledges that IGF-I is increased in milk from rBGH-treated cows. The Canadian report concludes, "There is insufficient information [about IGF-I] to provide a quantitative risk assessment; therefore, many potential health concerns remain unresolved."
** The Canadian government report offered additional data which, if corroborated, could have prevented U.S. FDA from approving rBGH for injection into cows. FDA says that, before a drug can be approved for use in animals, "the company must show that the drug is effective and safe for the animal."[2,pg.875] The Canadian government report (pg. 29) says, "Evidence from the animal safety reviews were [sic] not taken into consideration. These studies indicated numerous adverse effects in cows, including birth defects, reproductive disorders, higher incidence of mastitis [infection leading to inflammation of the udder], which may have had an impact on human health." Furthermore, the Canadian government report says (pg. 14), "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 rBST [rBGH], and covered up negative trial results. All the four U.S. manufacturers [Monsanto, Eli Lilly, Cyanamid and Elanco, with only Monsanto actually marketing a product] refused to disclose the lists of their research grants to U.S. universities." Without such lists, one could not inquire what effects (if any) had been revealed by animal experiments.
The Canadian government report concludes (pg. 5) that, in Canada, "Both procedural and data gaps were found which fail to properly address the human safety requirements of this drug under the Food and Drugs Act and Regulations." It is evident from the Canadian report that the U.S. approval process for this drug was equally flawed. None of the questions raised by the Canadian government scientists have been addressed by U.S. FDA.
--Peter Montague
BRIDGE TO THE HIGH ROAD, PART 3
In his path-breaking paper, BUILDING THE BRIDGE TO THE HIGH ROAD,[1] Dan Swinney tells two stories that illustrate "the low road of economic development."
Taylor Forge
In 1975, Swinney was a turret lathe operator for Taylor Forge in Cicero, Illinois, a suburb on Chicago's west side. Taylor Forge made large industrial castings and pipe fittings. That year Gulf+Western (G+W) secured a huge loan from Chase Manhattan Bank and began buying up successful manufacturing firms, like Taylor Forge, breaking them up, and selling off the pieces.
G+W had no interest in the companies it purchased, the products they manufactured, or the communities they supported. Later, a case study at the Harvard Business School described it this way: G+W's strategy was to "milk the cash cow," sell off Taylor Forge's assets and use the cash to acquire companies in more lucrative sectors, such as Paramount Pictures. G+W began selling off Taylor Forge department by department. In 1982 G+W cynically told employees they could save their jobs if they took pay cuts and gave back part of their pensions, which the employees did. But this turned out to be a trick to see how much G+W could extract from the employees before closing Taylor Forge for good, which occurred in 1983.
The city of Cicero lost half its good jobs in the next six years as "the low road" became the norm and many other viable companies went the way of Taylor Forge. As a result, the U.S. lost a significant portion of its productive capacity and speculators like G+W turned enormous profits. The low road became firmly established as the modern way of doing business in the U.S., the era of the "casino economy" emerged, and the pathology of the inner city began to appear.
Stewart Warner
In the early '80s, Stewart Warner, manufacturer of gauges and automotive instruments, and an economic anchor of Chicago's north side, began asking its unionized workers for concessions during contract negotiations. Detailed analysis of the situation revealed that Stewart Warner's management had lost interest in the firm and was planning to sell its assets. Dan Swinney's Midwest Center for Labor Research (MCLR) urged the workers at Stewart Warner to make an offer to buy the company, but for various reasons this did not happen. Within a year Stewart Warner was purchased by British Tire and Rubber, a conglomerate with a habit of buying U.S. companies and closing them or moving them to the maquiladora zone in Mexico. Sure enough, within 2 years, part of Stewart Warner's production was moved to Mexico, the Chicago plant was demolished, and the British firm turned a nice profit by building high-priced condos on the former factory site.
According to MCLR research, this plant closing cost the community 2500 jobs in related businesses, $10 million annually in federal, state, and local taxes, and $24 million annually in lost consumer spending. Furthermore, MCLR's analysis showed that a realistic business plan could have sustained Stewart Warner as a profitable source of income and investment for the Chicago economy, but the workers and the community did not mobilize to keep the firm rooted, so it was lost.
Simultaneously, another problem was brewing. Hundreds of Chicago's small manufacturing firms faced an uncertain future because their founders were growing old and had no one to replace themselves. MCLR studied 800 Chicago manufacturing firms with an owner 55 or older and found that 40% were in danger of closing because they had no one lined up to take over. MCLR discovered that these companies could often be saved with a little effort and creativity.[2] Such firms often present good opportunities for employee buyouts. Or they may provide an excellent chance for aspiring local entrepreneurs, who are typically African Americans or Hispanics previously excluded from this kind of opportunity.
As speculators created the "casino economy" and sold off many of the nation's productive assets, those hardest hit were people of color and women in the central cities. In every serious analysis of these problems, race remains a key indicator of inequality, discrimination and oppression.[3] While Republicans and Democrats both sing the praises of our "Dream Economy," many U.S. inner cities have become indistinguishable from the poorest parts of the developing world. Fifty-percent (or greater) unemployment, soaring infant mortality, hunger and homelessness are characteristic. If there is work to be had, it pays poverty wages that won't support a family, so people grow cynical and start seeing the underground economy as the only possible path to success. Over the past 25 years, life in our central cities has become distorted by crime, drugs and all the other forms of social pathology that accompany extreme poverty.[3] The larger society has responded with a policy of mass incarceration, plus "white flight" to the suburbs, thus creating all the environmental and social dislocations known as "sprawl."
As these events have unfolded, it has become clear that many members of the business class have abandoned the obligations of stewardship of the economy. For the first 75 years of this century, wealthy industrialists claimed the exclusive right to make decisions about what products would be produced from what raw materials, using what processes. They controlled decisions about management, investment, and production. In return for this awesome (and largely undisputed) power, they agreed to share a modicum of the available wealth, thus creating the middle class.
Most of the time this social contract has worked well enough to avoid major strife.
But starting in the '70s, it became clear that many of the nation's business leaders were abandoning the social contract, selling off the nation's assets, destroying America's productive capacity, abandoning communities that depended on the jobs.
Now, Dan Swinney says, conditions are ripe for a new paradigm of economic development --one aimed at ending historical oppressions, putting democratic control and community well being at the center of the picture, accepting responsibility for lean, efficient, productive, profitable, and environmentally sustainable business enterprises, rebuilding the nation's cities, and thus putting limits on the environmental desecration and social isolation created by sprawl. Swinney believes we can attract a majority of Americans to such a vision because --done right --the vast majority of people will benefit.
The key to success will be ownership, Swinney says (pg. 72). "This is the critical determinant of how production is organized, the link between the company and other companies or the community; its patterns of employment and training, and the level of commitment to affirmative action and environmental standards."
"We must be prepared to have people with our values and priorities purchase and develop local industries. This can be accomplished in a number of ways: employee ownership, community shares in local companies plus positions on the Board of Directors, and ownership by local entrepreneurs directly linked to community initiatives and organizations. In these ways, we can most directly promote development with new standards and objectives consistent with community needs," Swinney says.
"To mobilize the grass-roots support necessary to our vision, the relationship of an enterprise to the community must change in three fundamental ways," Swinney says.
"First, we must democratize the workplace itself. This involves seeking non-discrimination and affirmative action, greater control by working people over safety and other conditions of work, and greater participation by employees in matters affecting their lives, which have traditionally been reserved exclusively for management.
"Second, we must democratize relations among enterprises of the community. This requires facilitating their cooperation with and support for each other, and their common support for the community as a whole.
"Third, we must democratize the relationship of the enterprise to the community by finding ways for the community to evaluate and monitor a business's contribution to its overall economic, social, and cultural growth."
Obviously, none of these three requirements is simple or easy, but all are consistent with the premiss that democracy has become an essential requirement for any industrialized human culture that hopes to survive for very long. (See REHW #618.)
Swinney goes on to describe briefly four essential organizations that will be needed as we make the transition from low road development to high road development:
1) The ENTERPRISE DEVELOPMENT COMPANY (EDC), a center for the technical side of development. Such an organization is needed to provide the full range of services and expertise to acquire, manage, and develop businesses consistent with the economic and social goals of a broad coalition. The EDC can function as a clearinghouse for information about local businesses gathered from a network of sources, including churches, community organizations, development corporations, city government, labor (organized and unorganized), and residents.[2]
The EDC will assist a company to develop financial resources through contacts with individuals, venture funds, banks and grant sources, and also will provide technical services such as accounting, legal, marketing, and management assistance. Examples of EDCs are Cooperative Health Care Associates in the Bronx, N.Y., and the Steel Valley Authority (SVA) in the Pittsburgh, Pennsylvania area.
2) The LINKED ENTERPRISE NETWORK aims to promote communication among companies that do similar work, to promote common purchasing and marketing arrangements, promote worker training and education, and establish links between businesses and community groups. At its most ambitious, such a network seeks to tie companies together formally to pool capital and resources for development, and to create educational, cultural and research institutions that, together, can provide member firms with greater economic strength and leadership. Examples include the Garment Industry Development Corporation in New York City and the Candy Institute, serving the needs of candy manufacturers in Chicago.
3) The umbrella community organization is harder to define, but essential. The key to this strategic concept is community control of the economy. However, as Swinney says, the ability to control is earned, not declared. At the beginning of such projects, the level of control is minuscule. Likewise, democracy is created through a process. A project cannot simply declare that it is "acting on behalf of the community." Democratic structures must evolve as people take advantage of opportunities to work together, develop trust, then widen the circles of inclusion. There is no formula for how such organizations can be built, Swinney says. Examples operating today include the Naugatuck Valley Project in western Connecticut, Sustainable Milwaukee, and the New Chicago Campaign.
4) It's not enough to work out the practical application of this vision at the company and community level. Comprehensive development policies must be fought for in all the institutions that help shape public opinion and are designed to serve the public. The work will almost always begin in a particular company in a particular community, but ultimately it must translate into public policy, and government must become the agent for expanding and promoting the vision.
Swinney says, "People do not organize for change just because they are oppressed or exploited. They organize FOR something." BUILDING THE BRIDGE TO THE HIGH ROAD lays out a vision of something we can all be FOR --a vision of a decent, fair, environmentally sustainable society, and a commitment to apply this strategic vision AT THE COMPANY LEVEL OF THE ECONOMY. For most of us, this is new. And important.
Again we urge all our readers, including government officials and business people, to join Sustainable America, so that, together, we can build a strong infrastructure for ongoing multi-issue work. Check out www.sanetwork.org, send E-mail to sustamer@sanetwork.org, or telephone executive director Elaine Gross in New York City: (212) 239-4221.
NOTICE
Environmental Research Foundation provides this electronic version of RACHEL'S ENVIRONMENT & HEALTH WEEKLY free of charge even though it costs our organization considerable time and money to produce it. We would like to continue to provide this service free. You could help by making a tax-deductible contribution (anything you can afford, whether $5.00 or $500.00). Please send your tax-deductible contribution to: Environmental Research Foundation, P.O. Box 5036, Annapolis, MD 21403-7036. Please do not send credit card information via E-mail. For further information about making tax-deductible contributions to E.R.F. by credit card please phone us toll free at 1-888-2RACHEL, or at (410) 263-1584, or fax us at (410) 263-8944. --Peter Montague, Editor
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