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#402 - The Making Of A Public Health Crisis, 10-Aug-1994

Policies of the U.S. Food and Drug Administration (FDA) appear to be
contributing to the development of a public health crisis. FDA approval
of a growth hormone (rBGH) for use in cows, and approval of the Flavr
Savr genetically-engineered tomato, both may increase the number of
antibiotic-resistant disease organisms.

Germs resistant to antibiotics are one of the medical community's worst
nightmares. Diseases that we routinely cure with antibiotics and ONLY
with antibiotics --such as typhoid fever, cholera, meningitis,
pneumonia, gonorrhea, syphilis, and tuberculosis --are now appearing in
forms that resist antibiotics. As the trend continues, we slip backward
toward conditions that existed prior to 1928 when Arthur Fleming
discovered penicillin, the first antibiotic. Prior to 1928, infectious
diseases killed Americans by the tens of thousands each year. A simple
wound or surgical incision could lead to fatal blood poisoning; a
child's ear infection could turn into lethal meningitis; common
pneumonia often ended in death. For 50 years the world has enjoyed a
reprieve from these brutal conditions, all because of 100-or-so
antibiotics.

According to agricultural experts, the use of synthetic growth hormone
(rBGH) in milk cows, to boost milk production, increases the incidence
of mastitis, an infection of the udder, which can contribute pus to
milk.[1] Pus in milk can reduce, or destroy, the commercial value of
the milk, so farmers fight mastitis by treating their cows with
antibiotics.

The widespread use of antibiotics in livestock is ALREADY causing human
disease germs, like salmonella, to develop resistance to antibiotics.
The chain, rBGH--> mastitis--> antibiotics, simply promises to make an
already-serious problem worse.

Consider the return of tuberculosis. A writer in SCIENCE said in 1992,
"After a century of decline in the United States, tuberculosis is
increasing, and strains resistant to multiple antibiotics have
emerged.... The steadily declining incidence of TB in the United States
since 1882 has been reversed since 1985, with 26,283 cases reported in
1991. To the trend of increasing incidence one must add the ominous
emergence of drug-resistant strains that threaten our capability of
controlling the disease. One-third of all cases tested in a New York
City survey in 1991 were resistant to one or more drugs."[2]

TB was the leading cause of death in the United States until the 1950s
when improved sanitation and antibiotics brought it under control. TB
spreads when TB victims cough, sneeze or even sing and others nearby
breathe their germs. Today, antibiotics are our only reliable control
for TB. The progressive loss of antibiotics as a weapon against TB has
health officials shaking their heads in dismay.

The New York TIMES last month reported an epidemic of TB at middle-
class La Quinta High School in Westminster, California, 25 miles
southeast of downtown Los Angeles.[3] Twenty-three percent of the 1270
students at La Quinta tested positive for TB in 1993 and the number has
risen since then. Twelve students are being treated for active cases of
multiple-drug-resistant TB (MDRTB) and 70 other students known to have
been exposed to MDRTB are being monitored by x-ray examination of their
lungs, the TIMES said.

Tuberculosis is not the only serious human disease becoming resistant
to antibiotics. Others are pneumonia; streptococcus infections (such as
"strep throat," impetigo, scarlet fever, and rheumatic fever[4]);
staphylococcus infections ("staph infections"--serious blood infections
common in hospitals); shigella; salmonella; cholera; dysentery and
others.[5] According to the federal Centers for Disease Control (CDC),
in 1992, 13,300 hospital patients died of bacterial infections that
resisted the antibiotics that doctors used against them.[6]

Earlier this year, at the annual meeting of the American Association
for the Advancement of Science, microbiologist Alexander Tomasz of
Rockefeller University warned that antibiotic-resistant germs represent
"nothing short of a medical disaster."[7]

Drug resistance occurs when a colony of bacteria is dosed with an
antibiotic. Most of the bacteria die, but a few hardy ones survive
because, by chance, they harbor genes that make them immune to the
drug. These hardy creatures thrive and proliferate, passing their
resistant genes to their progeny. (One bacteria can give rise to
16,777,220 offspring in 24 hours.)

Furthermore, mutant bacteria can share their resistant genes with
unrelated bacteria. When two bacteria touch each other (say, in the mud
of a barnyard, in a hospital bed sheet, or in a human stomach), they
can exchange a loop of DNA called a plasmid --thus transferring
resistance from one organism to another. Even a relatively benign
bacteria, such as E. COLI, common in the human gut, can develop
antibiotic resistance and then pass that resistance, via plasmid
transfer, or by other means, to bacteria that cause a fatal disease
such as cholera or typhoid fever.[8]

Experts agree there are two causes of antibiotic resistance among
bacteria: overuse of antibiotics in humans and in farm animals.

Humans: Because patients have come to expect antibiotics from their
doctor, doctors now prescribe antibiotics for many ailments that
antibiotics cannot cure --such as viral infections like the common
cold. The result of such misuse is the development of antibiotic-
resistant germs. The World Health Organization (WHO) calls it "a
situation which is fast becoming a global public health problem."[9]

Even when an antibiotic is prescribed properly, if the patient stops
taking it (because he or she feels better after 2 or 3 days), this
causes growth of drug-resistant bacteria. People who save up
antibiotics to self-medicate themselves later, and people who take
portions of other peoples' prescription antibiotics, worsen the problem
of resistance.

Farm animals: Someone discovered in the 1950s that feeding low levels
of antibiotics to livestock will increase weight-gain. Even today no
one understands how this works, but for 40 years farmers--urged on by
drug and chemical companies--have fed antibiotics to healthy animals to
speed growth. An estimated 15 million pounds, about half of all
antibiotics, are fed to farm animals.

Ironically, the FDA (U.S. Food and Drug Administration) recognized the
public health implications of this problem 17 years ago, in 1977, and
published a FEDERAL REGISTER notice announcing its intention to curb
the routine feeding of antibiotics to livestock. Drug and livestock
corporations responded by bringing intense pressure on Congress, which
promptly ordered FDA to back off. Everyone agreed that using
antibiotics in livestock (cows, sheep, pigs and chickens) was creating
disease organisms resistant to antibiotics. But corporate lobbyists
argued then that no one knew for sure that such organisms could infect
humans. Since that time, definitive evidence has come to light,[10] but
FDA still has not acted.

Today there is no doubt that routinely dosing farm animals with
antibiotics is creating a serious public health problem for humans.
Some responsible officials are already calling it a public health
emergency.[5] Eleven years ago, in 1983, 300 scientists petitioned the
FDA to control the use of antibiotics on the farm.[11] But the FDA
remains paralyzed and antibiotics remain freely available without
prescription.

In July of this year, we walked into Bowen's Farm Supply in Annapolis,
Md., and purchased, off the shelf, a 100-milliliter bottle of
penicillin-G for $9.29. We also bought 6.4 ounces of the Aureomycin
brand of tetracycline for $3.49. Penicillin and tetracycline are potent
antibiotics. Also available was tetracycline selling under the trade
name Terramycin. The Terramycin package insert said, "Terramycin used
right after birth gives them the protection they need... Starts them
off faster to more profitable gains." The insert urged routine
treatment of cattle and calves, pigs and hogs, sheep, mink, poultry and
bees with tetracycline to prevent disease.

FDA's failure to control antibiotic abuse is symptomatic of the
agency's weakness in controlling the behavior of powerful corporations.
In justifying its decision to approve bovine growth hormone (rBGH) in
milk cows, FDA simply did not discuss the problem of mastitis leading
to increased antibiotic use which promises to make a big public health
problem bigger.[12]

Likewise, in its decision this year to allow Calgene's Flavr Savr
genetically-engineered tomato onto the mar-ket, FDA did not answer all
the critics of the Flavr Savr. The Flavr Savr tomato contains a gene
that is resistant to the antibiotic kanamycin. Some geneticists warned
that the resistant gene can be transferred to other bacteria in
peoples' stomachs and intestines, creating new antibiotic-resistant
germs with potentially serious public health consequences.[13] FDA
remained silent and gave Calgene what it wanted.

Available evidence forces the conclusion that antibiotic-resistant
disease organisms are already threatening public health in important
ways, world-wide. What prevents decisive action by responsible
authorities is the unrestrained political influence of certain
corporations. It seems clear that, until we learn to control the
behavior of such corporations, this public health problem will grow
steadily toward crisis proportions.

--Peter Montague

=====

[1] David S. Kronfeld, "Safety of Bovine Growth Hormone," SCIENCE Vol.
251 (Jan. 18, 1991), pgs. 256-257. And: T.B. Mepham, "Public health
implications of bovine somatotropin use in dairying: discussion paper,"
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE Vol. 85 (December 1992), pgs.
736-739. And see, Eleanor Chelimsky and others, RECOMBINANT BOVINE
GROWTH HORMONE: FDA APPROVAL SHOULD BE WITHHELD UNTIL THE MASTITIS
ISSUE IS RESOLVED [GAO/PEMD-92-26] (Gaithersburg, Md.: U.S. General
Accounting Office, 1992).

[2] Barry R. Bloom and Christopher J.L. Murray, "Tuberculosis:
Commentary on a Reemergent Killer," SCIENCE Vol. 257 (August 21, 1992),
pgs. 1055-1064.

[3] "California School Becomes Notorious For Epidemic of TB," NEW YORK
TIMES July 18, 1994, pgs. A1, B6.

[4] Karen Wright, "Bad New Bacteria," SCIENCE Vol. 249 (July 6, 1990),
pgs. 22-24.

[5] Mitchell L. Cohen, "Epidemiology of drug resistance: implications
for a post-antimicrobial era," SCIENCE Vol. 257 (August 21, 1992), pgs.
1050-1055.

[6] Sharon Begley, "The End of Antibiotics," NEWSWEEK Vol. 123 (March
28, 1994), pgs. 47-52.

[7] Sharon Begley, "The End of Antibiotics?" NEWSWEEK Vol. 123 (March
7, 1994), pg. 63. See also, John Travis, "Reviving the Antibiotic
Miracle?" SCIENCE Vol. 264 (April 15, 1994), 360-362.

[8] Harold C. Neu, "The Crisis in Antibiotic Resistance," SCIENCE Vol.
257 (August 21, 1992), pgs. 1064-1073.

[9] Jean-Daniel Rainhorn, "Antibiotics: An overworked remedy," WORLD
HEALTH (March-April 1992), pg. 14.

[10] Marjorie Sun, "Antibiotics and animal feed: a smoking gun,"
SCIENCE Vol. 225 (September 21, 1984), pg. 1375.

[11] Eliot Marshall, "Scientists endorse ban on antibiotics in feeds,"
SCIENCE Vol. 222 (November 11, 1983), pg. 601.

[12] Judith C. Juskevich and C. Greg Guyer, "Bovine Growth Hormone:
Human Food Safety Evaluation." SCIENCE Vol. 249 (1990), pg. 877.

[13] Joseph E. Cummins, "The Use of the Cauliflower Mosaic Virus 35S
Promoter (CaMV) in Calgene's Flavr Savr Tomato Creates Hazard."
Unpublished paper dated June 3, 1994. Dr. Cummins is associate
professor of genetics in the department of plant sciences at the
University of Western Ontario in London, Ontario.

Descriptor terms: fda; bgh; flavr savr; antibiotics; resistance;
typhoid fever; cholera; meningitis; pneumonia; gonorrhea; syphilis;
tuberculosis; arthur fleming; penicillin; mastitis; farming; dairying;
agriculture; veterinary medicine; salmonella; new york, ny; la quinta
high school, westminster, ca; westminster, ca; streptococcus; strep
throat; impetigo; scarlet fever; rheumatic fever; staphylococcus; staph
infections; nosocomial infections; shigella; salmonella; cholera;
dysentery; alexander tomasz; dna; plasmid; world health organization;
who; aureomycin; terramycin; tetracycline; corporations; calgene;
kanamycin;