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#383 - Drug Experiments On The Public, 30-Mar-1994

The U.S. Food and Drug Administration (FDA) has approved the use of a
genetically-engineered growth hormone for injection into milk cows, the
first genetically-engineered food product approved by FDA. As a result,
the genetically-engineered hormone (called rBGH, or recombinant bovine
growth hormone) will now appear in milk, cheese, yogurt, ice cream,
dairy-derived hamburger, many processed foods such as baked goods, and
baby formula. FDA says the genetically-engineered product is the same
as ("not significantly different from") naturally-occurring bovine
growth hormone (BGH) but some scientists have pointed out that this is
not true. Natural BGH and the recently-approved rBGH differ in their
chemical structures.[1] FDA says neither BGH nor rBGH has any
biological effect in humans, but David S. Kronfeld of Virginia
Polytechnic Institute and others ask whether rBGH may stimulate an
immune response or an allergic reaction in some people. FDA says this
possibility is "insignificant" and has refused to conduct human tests.
[2] Whether people exhibit immune responses or allergic reactions to
rBGH will now be discovered by exposing the general public to this
drug. In essence, FDA has given rBGH producers permission to conduct a
large-scale experiment on the public, without a control population.

Bovine growth hormone causes cows to produce more milk, but it does not
act directly. Instead, BGH releases a chemical called IGF-1 ("insulin-
like growth factor #1") which then causes increased milk production.[3]
IGF-1 is a normal constituent of milk from both cows and humans.
Several studies have shown that milk from rBGH-treated cows contains
elevated concentrations of IGF-1. This is important because IGF-1 is
chemically identical in cows and in humans--a fact FDA did not know
when the agency first declared rBGH "safe" for human consumption in
1985. Thus rBGH-treated cows will very likely produce milk that
contains increased levels of a growth factor known to be biologically
active in humans. The consequences of this are unknown, but FDA has
said the risks--whatever they may be--are worth taking. (FDA does not
balance risks against benefits, but two benefits of rBGH use have been
identified: an estimated $300 to $500 million in annual income to
Monsanto, the only company presently marketing an FDA-approved rBGH,
and an estimated 12% increase in the nation's supply of milk. Since the
nation already produces more milk than it can use, the federal
government will purchase the additional milk at an estimated cost to
the taxpayer of $200 million or more per year.)

When an expert committee of the federal National Institutes of Health
(NIH) examined the rBGH issue, it concluded that milk and meat from
rBGH-treated cows are as safe as from cows not treated. However, they
noted that, "Whether the additional amount of IGF-1 in milk from [rBGH-
treated] cows has a local effect on the esophagus, stomach or
intestines is unknown." Among the report's six recommendations was,
"Determine the acute and chronic local actions of IGF-1, if any, in the
upper gastrointestinal tract."[4] This has not been done. Perhaps the
uncontrolled experiment now being conducted on the public by FDA and
Monsanto will reveal new information on this point.

The NIH panel chose not to consider the issue of cow health or the
secondary human health consequences of cow health. As we pointed out in
RHWN #381 and #382, there is abundant evidence indicating that cows
treated with rBGH are more prone to udder infections called mastitis.
Mastitis infections add pus to milk. Because increased pus diminishes
the value of milk, dairy farmers respond to mastitis with antibiotics,
often unapproved and illegal antibiotics. (Mastitis presently costs
dairy farmers $2 billion each year, or $200 per cow per year on the
average dairy farm.[5])

Indeed, leaked internal documents reveal that Monsanto itself used
several unapproved drugs to control mastitis increases in its rBGH test
herds.[6]

In 1990, an FDA survey found antibiotics and sulfa drugs in 51% of 70
milk samples taken in 14 cities.[7] Subsequently FDA announced it had
found no antibiotics in a follow-up survey, but the WALL STREET JOURNAL
reported two months later that FDA had actually found drugs in 80% of
the samples.[8] An FDA spokesperson acknowledged that antibiotics are
"widely misused" by dairy farmers and veterinarians.[9]

A CBS-affiliated TV station in New York conducted its own survey of
milk from stores in New York, New Jersey and Connecticut in early 1990
and reported that 80% of 50 samples contained tetracyclines, a family
of antibiotics. The survey also revealed that 26% of the samples were
tainted with the drug sulfamethazine, a suspected carcinogen banned
from dairy use.[10]

In 1993, federal General Accounting Office (GAO) recommended that FDA
not approve rBGH until the question of secondary health effects
(mastitis --> antibiotics --> humans) has been resolved. On March 2,
1993, the GAO sent a letter to Donna Shalala, Secretary of Health and
Human Services (of which FDA is a part) saying that in interviews FDA
officials "did... acknowledge the possibility that there was an
antibiotic-human food safety concern that they should investigate."
But, GAO said, subsequent communications from FDA "did not address our
concern: does rBGH use result in higher concentrations of antibiotics
in milk or not, and if so, is the higher level acceptable from a food
safety standpoint?" The GAO went on to note that FDA has said its
review of human food safety issues has been completed. GAO asked, "But
how can a food safety determination be made when the rBGH-mastitis-
antibiotic issue has not been addressed, much less resolved?" "In
conclusion," the GAO said, "we would like to point out that the
increase in mastitis levels reported in the rBGH pivotal studies
suggests that the potential for an increase in milk antibiotic levels
is very real... [The FDA's] response suggests that our recommendations
have not been seriously addressed."[11] FDA went ahead and approved
rBGH.

How can Monsanto risk an experiment on the milk supply of the American
public? If widespread harm should occur, might not the company be
liable for billions of dollars in damages and possible bankruptcy?

Luckily for Monsanto, and others similarly situated, recent court
rulings have provided safe shelter for corporations whose consumer
products result in massive litigation.

The new corporate shelter was invented by Judge Jack Weinstein in the
case of Vietnam veterans seeking damages from Dow, Diamond Shamrock,
Monsanto and other companies that produced Agent Orange. Agent Orange
was an herbicide used in Vietnam to defoliate jungles. Many American
troops exposed to the chemical during the war say they and their
children were harmed. The National Academy of Sciences and the Veterans
Administration in 1993 said the vets WERE harmed.[12]

The courts allowed the companies to settle with some of the plaintiffs
for a fixed amount, with the stipulation that no future lawsuits can be
brought against the Agent Orange manufacturers, even by people who
weren't party to today's settlement because they did not know they had
been harmed. In future, if a person develops a disease they believe was
caused by Agent Orange, they cannot sue --their Constitutional right to
due process was extinguished by the original settlement.

This is exceptionally important because litigation typically proceeds
in stages. As we saw in the case of asbestos, each new lawsuit brings
forth more evidence of what a company knew when. Jury awards and
penalties increase as a company's deceptions and coverups are
progressively revealed. The first plaintiffs may fail completely, but
the 20th or 50th may be awarded many millions of dollars in
compensatory and punitive damages, as the courts see, and then punish
companies for, a pattern of unethical behavior.

The new legal doctrine cuts off the possibility of a series of suits
against a company, thus providing almost complete protection against
suits that might cause bankruptcy.

This new legal doctrine has recently been used to limit the liabilities
of companies that marketed silicone breast implants. It is a creative
legal invention which sharply limits the liability of corporations that
market possibly-harmful products that have not been fully tested for
safety. Recently more than 8 million Vietnam veterans asked the U.S.
Supreme Court to review this new legal doctrine, on the ground that
their Constitutional rights had been taken from them. The attorney
generals of all 50 states joined with the vets asking the Supreme Court
to review this new doctrine.[13] The Supreme Court refused. And that is
one reason why companies are willing to risk exposing the general
public to drugs in their food without fully understanding the
consequences. Under doctrines invented by the Reagan/Bush courts,
corporations are protected but the public is not.

--Peter Montague

=====

[1] A reader, Robert Plano, points out that in RHWN #382 we erroneously
understated the degree of difference between natural BGH and Monsanto's
synthetic rBGH; in RHWN #382 we said rBGH is natural BGH with an amino
acid (methionine) added; in fact, Plano points out, FDA says Monsanto's
product is the natural BGH with one amino acid removed (alanine) and
another added (methionine); see Judith C. Juskevich and C. Greg Guyer,
"Bovine Growth Hormone: Human Food Safety Evaluation." SCIENCE Vol. 249
(1990), pg. 877. FDA says these differences make no difference.

[2] David S. Kronfeld, "Recombinant Bovine Growth Hormone: Cow
Responses Delay Drug Approval and Impact Public Health" in William C.
Liebhardt, THE DAIRY DEBATE; CONSEQUENCES OF BOVINE GROWTH HORMONE AND
ROTATIONAL GRAZING TECHNOLOGIES (Davis, Cal.: University of California
Sustainable Agriculture Research and Education Program, 1993), pgs. 67-
112. Kronfeld raised this point in "Safety of Bovine Growth Hormone,"
SCIENCE Vol. 251 (January 18, 1991), pg. 256, and FDA responded in
SCIENCE Vol. 251 (January 18, 1991), pgs. 256-257.

[3] T. B. Mepham, "Public health implications of bovine somatotrophin
[sic] use in dairying: discussion paper," JOURNAL OF THE ROYAL SOCIETY
OF MEDICINE Vol. 85 (December 1992), pgs. 736-739.

[4] Melvin M. Grumbach and others, "NIH Technology Assessment
Conference Statement on Bovine Somatotropin," JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION Vol. 265 No. 11 (March 20, 1991), pgs. 1423-1425.

[5] William M. Murphy and John R. Kunkel, "Sustainable Agriculture:
Controlled Grazing vs. Confinement Feeding of Dairy Cows," in William
C. Liebhardt, THE DAIRY DEBATE; CONSEQUENCES OF BOVINE GROWTH HORMONE
AND ROTATIONAL GRAZING TECHNOLOGIES (Davis, Cal.: University of
California Sustainable Agriculture Research and Education Program,
1993), pg. 121.

[6] Samuel S. Epstein and Peter Hardin, "Confidential Monsanto Research
Files Dispute Many BGH Safety Claims," THE MILKWEED [Madison, WI;
phone: 608/455-2400] Vol. 128 (1990), pgs. 3-6, discussing P.J. Eppard
and others, TOXICITY OF CP115099 IN A PROLONGED RELEASE SYSTEM IN
LACTATING COWS. REPORT MSL 6345. (St. Louis, Mo.: Monsanto Agricultural
Co., 1987).

[7] Bruce Ingersoll, "Technology & Health: FDA Detects Drugs in Milk
But Fails to Confirm Results," WALL STREET JOURNAL February 6, 1990,
pg. B6.

[8] Bruce Ingersoll, "Politics and Policy: GAO Says FDA Can't
Substantiate Claims About Milk," WALL STREET JOURNAL November 21, 1990,
pg. A16.

[9] Bruce Ingersoll, "Technology & Health: FDA Plans a Nationwide Test
of Milk for Antibiotics, Other Drug Residues," WALL STREET JOURNAL
December 28, 1990, pg. 10.

[10] Bruce Ingersoll, "New York Milk Supply Highly Tainted, TV Station
Says, Based on Own Survey," WALL STREET JOURNAL February 8, 1990, pg.
unknown.

[11] Correspondence from Eleanor Chelimsky, Assistant Comptroller
General, General Accounting Office, to Donna E. Shalala, Secretary of
Health and Human Services, March 2, 1993.

[12] Institute of Medicine, VETERANS AND AGENT ORANGE: HEALTH EFFECTS
OF HERBICIDES USED IN VIETNAM (Washington, D.C.: National Academy
Press, 1993).

[13] P.B. Onderonk, Jr. and others, "No. 93-860 In the Supreme Court of
the United States, October Term, 1993, Shirley Ivy... v. Diamond
Shamrock... on Petition for Writ of Certiorari to the United States
Court of Appeals for the Second Circuit."

Descriptor terms: fda; genetic engineering; biotechnology; bgh; food
safety; david kronfeld; immune system; allergies; allergens; milk;
hormones; igf-1; nih; monsanto; cows; animal health; mastitis;
antibiotics; sulfa drugs; tetracycline; sulfamethazine; carcinogens;
donna shalala; hhs; gao;