RACHEL'S ENVIRONMENT & HEALTH WEEKLY #383

                    ---March 31, 1994---

                          HEADLINES:

               DRUG EXPERIMENTS ON THE PUBLIC

=================================================================

DRUG EXPERIMENTS ON THE PUBLIC

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;

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       --Peter Montague, Editor
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