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#661 - Precaution and PVC in Medicine, Pt. 1, 28-Jul-1999

The chlorine industry is desperate to avoid a ban on PVC plastic
(also known as polyvinyl chloride, or simply "vinyl") but it's
going to be an uphill battle.

Many chlorine-containing chemicals are toxic and long-lived and
they tend to concentrate as they move up the food chain.
Therefore, as the 20th century draws to a close, many high-volume
chlorinated chemicals have already been phased out in countries
around the world, and many more are under growing pressure:

** Chlorinated pesticides such as DDT, toxaphene, chlordane and
heptachlor have been banned in many countries because they are
toxic and long-lived and they kill creatures they were never
intended to kill.

** CFCs [chlorofluorocarbons] are being phased out by
international treaty because they have damaged the Earth's ozone
shield;

** PCBs [polychlorinated biphenyls] were banned in many countries
20 years ago because they accumulate in food chains and interfere
with the hormones of mammals, causing numerous kinds of subtle
damage;

** Many industries are reducing their use of chlorinated solvents
as they rediscover soap and water for de-greasing.

The chlorine industry has been able to absorb these phase-outs by
creating new markets for chlorine, notably PVC plastic, or vinyl.
Nearly one-third of the world's production of chlorine now goes
into making PVC and the chlorine industry has big plans for
increasing this proportion. PVC is supposed to remain the main
"sink" for excess chlorine into the 21st century.

Saving PVC will not be easy. Just this year, many countries have
imposed restrictions on soft PVC toys that contain "phthalates"
(a class of chemical additives -- see REHW #603). During 1999,
restrictions on PVC toys have been imposed by Austria, Canada,
Denmark, Finland, Mexico, Norway, the Philippines, Germany,
France, Greece and Sweden.[1]

Realizing that the stigma against PVC toys could spread to other
PVC products, the Vinyl Institute initiated a $1 million ad
campaign in 1999, highlighting the use of PVC in medicine.[2]

The pro-PVC ads ran on TV, in the WASHINGTON POST, and in ROLL
CALL (a newspaper circulated mainly on Capitol Hill in
Washington, D.C.). The ads depict a group of doctors and nurses
in an operating room, along with PVC equipment such as
intravenous (IV) bags, tubing and respiratory equipment. The ad
explains that "medical professionals have placed their trust in
one material time and time again: vinyl."[3]

Although PVC medical products comprise only 6% of the total North
American PVC market, one quarter of all plastic medical products
are made of PVC, including most IV bags and tubing.[4] Common PVC
medical devices include IV and blood bags, tubing, gloves,
catheters, ID bracelets, endotracheal tubes, feeding bags and
other equipment.

The Vinyl Institute's ads did little to quiet public concerns
about vinyl. Instead, they provoked action by a large and growing
coalition of public health advocates -- the Health Care Without
Harm campaign.[5]

Health Care Without Harm (HCWH) adapted its name from the
Hippocratic Oath -- the ethical creed of the medical profession
which obliges doctors and other practitioners to "first, do no
harm."

HCWH had previously identified PVC as the major culprit in the
generation of dioxin from medical waste incinerators, one of the
largest sources of dioxin in the U.S.[6] In 1996, Physicians for
Social Responsibility and other HCWH members convinced the
American Public Health Association -- the country's largest
association of public health professionals -- to call for a
phase-out of PVC in medical devices because PVC generates dioxin
when burned. Dioxin is a potent immune system poison, causes
cancer in humans and other animals, and interferes with the
hormone systems of mammals and other creatures.[7]

Similar resolutions seeking a ban on medical uses of PVC have
been passed by the Chicago Medical Society, the Minnesota Medical
Association, the California Medical Association and the American
Nurses Association.[8]

PVC is unique in the polymer world because it requires large
quantities of additives to achieve specific qualities. PVC is a
relatively rigid and brittle polymer, so flexibility is achieved
through the addition of chemical plasticizers. Other polymers can
be made more or less flexible through the rearrangement of
polymer chains or by mixing different polymers together, thus
eliminating the need for plasticizers. Approximately 90% of the
plasticizers produced globally end up in flexible PVC products.
While there are numerous plasticizers on the market, the largest
group, accounting for more than 69% of U.S. consumption, are the
phthalate esters. The phthalate most commonly used in the
production of PVC medical devices is Di-(2-ethylhexyl) phthalate,
also known as DEHP.

Earlier this year, Health Care Without Harm (HCWH) issued a
health alert about the leaching of phthalates from IV bags.[9]
HCWH also asked the Center for Sustainable Production at the
University of Massachusetts Lowell to evaluate the health risks
associated with human exposure to DEHP, as well as alternatives
to its use.[10]

The toy industry stopped using DEHP in 1986, shortly after the
U.S. EPA [Environmental Protection Agency] listed it as a
probable human carcinogen.[11]

Independent laboratory tests conducted for Greenpeace in early
1999 found that medical devices contain up to 81% (by weight)
DEHP.[12] By law, toys such as teething rings have been limited
to less than 3% DEHP, and U.S. FDA [Food and Drug Administration]
limits plasticizers in food containers to 30%.[13] However there
are no FDA restrictions on DEHP content or releases into the body
from PVC medical devices.

DEHP has been found to leach from IV bags, blood bags, tubing
(endotracheal and transfusion) and catheters into solutions,
blood products, and eventually into the human body.[14] Of
greatest concern is exposure to premature infants, hemophiliacs,
and dialysis patients, who suffer from compromised immune and
metabolic systems, have long term exposure to DEHP, or are
exposed at critical junctures in development.

Some drugs -- especially those with fatty components --accelerate the
DEHP leaching process. Taxol (used to treat breast
cancer, ovarian cancer, and AIDS-related Kaposi's sarcoma) is one
of the drugs with these characteristics.

Taxol's instructions for intravenous administration include this
paragraph: "Contact of the undiluted concentrate with plasticized
polyvinyl chloride (PVC) equipment or devices used to prepare
solutions for infusion is not recommended. In order to minimize
patient exposure to the plasticizer DEHP, which may be leached
from PVC infusion bags or sets, diluted Taxol solutions should
preferably be stored in bottles (glass, polypropylene) or plastic
bags (polypropylene, polyolefin) and administered through
polyethylene-lined administration sets."[15]

The two IV manufacturers with about 80% of the U.S. market,
Abbott Laboratories and Baxter Healthcare, print warnings about
the leaching of DEHP into a variety of solutions. The literature
that accompanies Baxter's Viaflex container, for instance,
advises that "solutions in contact with the plastic container can
leach out certain of its chemical components in very small
amounts within the expiration period, e.g., di-2-ethylhexyl
phthalate (DEHP) up to 5 parts per million."[16] As a 1994
article in the JOURNAL OF INTRAVENOUS NURSING warns, printed
instructions are not enough: hospital staff may not be aware that
DEHP leaches from PVC IV products, and may not routinely read
package literature that directs the use of non-vinyl
products.[17]

The Lowell Center's review examined the published literature on
animal laboratory studies, in-vitro studies in human and animal
cell lines, and available human exposure studies. It found
evidence that DEHP or its metabolite MEHP can affect the testes,
ovaries, kidneys, liver, circulatory system, pulmonary system and
heart.

There is consensus that DEHP causes a wide range of adverse
impacts in experimental animals, including cancer, testicular
atrophy, and cardiac toxicity. However, the relevance of these
results to humans is disputed. No long-term human studies have
been conducted. Nevertheless, many animal studies demonstrate
health effects from DEHP at exposure levels documented in people
who receive many blood transfusions, kidney dialysis patients and
high risk newborn babies:

** Hemodialysis patients may be exposed to 10 to 20 times more
DEHP than the levels that caused liver damage in rhesus
monkeys.[18]

** A hemorrhaging patient may receive more DEHP from PVC blood
bags and tubing than the equivalent amount that significantly
reduced the heart rate of rats.[19]

** An infant receiving Extracorporeal Membrane Oxygenation (ECMO)
therapy with PVC tubing may be exposed to more DEHP than the
level that damaged the testes of immature rats.[20]

Given the evidence of adverse effects of DEHP in laboratory
animals, evidence of human exposure, limited evidence of health
effects in humans, and uncertainty regarding the mechanism by
which these effects occur, it is clearly prudent to take a
precautionary approach to the health risks posed by DEHP in
medical devices.

The precautionary approach is receiving critical attention from
the public health community, which is why the PVC-in-medicine
issue has galvanized a huge industry backlash. More next week.

--by Charlie Cray

=====

[1] For a detailed list of restrictions and bans on PVC toys and
other products see Greenpeace International's web site: http://-
www.greenpeace.org/~comms/97/pvctoys/documents/-business_actions.html

[2] Steve Toloken, "$1 million advertising drive aiming to
resuscitate PVC," PLASTICS NEWS, November 23, 1998, p. 43.

[3] WASHINGTON POST, January 16, 1999.

[4] The Vinyl Institute. Vinyl Medical Products Help Save Lives.
1998. Available at www.vinylfacts.org/medical/index.html.

[5] The Health Care Without Harm coalition includes over 180
member organizations, including the American Nurses Association,
Physicians for Social Responsibility and numerous environmental
groups. For more information contact Health Care Without Harm see
}{f5 fs11 http://www.noharm.org; email: noharm@iatp.org; phone:
(703) 237-2249.

[6] See, Joe Thornton, Michael McCally and others, "Dioxin
Prevention and Medical Waste Incinerators," PUBLIC HEALTH REPORTS
Vol. 3 (July/August 1996), pgs. 298-313.

[7] "APHA Resolution 9607, Prevention of Dioxin Generation from
PVC Plastic Use by Health Care Facilities," AMERICAN JOURNAL OF
PUBLIC HEALTH Vol. 87, No. 3 (March 1997), pg. 501.

[8] Chicago Medical Society Resolution No. 98-28; Minnesota
Medical Association, Dioxins 1998; California Medical Association
Resolution 103-98; 1997 ANA House of Delegates Reduction of
Health Care Production of Toxic Pollution, 1997.

[9] Health Care Without Harm, "Vinyl IV Bags Leach Toxic
Chemicals, Health Alert February 23, 1999," available at
http://www.noharm.org/022399_IV_alert_release.htm.

[10] Joel Tickner and others, THE USE OF DI-2-ETHYLHEXYL
PHTHALATE IN PVC MEDICAL DEVICES: EXPOSURE, TOXICITY, AND
ALTERNATIVES (Lowell, Mass.: Lowell Center for Sustainable
Production, June 1999.) To get a copy, phone (703) 237-2249.

[11] See American Society for Testing and Materials,
Conshohocken, Penn., Designation: F 963- 96, section 4.3.8;
originally published in 1986.

[12] Joseph Di Gangi, PHTHALATES IN PVC MEDICAL PRODUCTS
(Washington, D.C.: Greenpeace USA, February 1999.

[13] U.S. Food and Drug Administration, 21 Code of Federal
Regulations 177.2600.

[14] TAXOL (paclitaxel) information sheet, Mead Johnson Oncology
Products.

[15] Baxter Healthcare Corporation, Dextrose and Sodium Chloride
Injection, USP in Viaflex Plastic Container product literature
7-19-2-317, Rev. November 1995 Deerfield, Ill.

[16] V. Noah and M.A. Godin, "A Perspective on
Di-2-Ethyl-Hexylphthalate in Intravenous Therapy," JOURNAL OF
INTRAVENOUS NURSING Vol. 17 (1997), pgs. 210-213.

[17] M.S. Jacobson and others, "Effects of a plasticizer leached
from PVC on the subhuman primate: A consequence of chronic
transfusion therapy," JOURNAL OF LABORATORY AND CLINICAL MEDICINE
Vol. 89 (May 1977), pgs. 1066-1079; Sherwin V. Kevy and May S.
Jacobson, "Hepatic effects of a phthalate ester plasticizer
leached from poly (vinyl chloride) blood bags following
transfusion," ENVIRONMENTAL HEALTH PERSPECTIVES Vol. 45 (1982),
pgs. 57-64.

[18] G. Rock and others, "Hypotension and cardiac arrest in rats
after infusion of mono(2-ethylhexyl)phthalate (MEHP) a
contaminant of stored blood," NEW ENGLAND JOURNAL OF MEDICINE
Vol. 316 (May 7, 1987), pgs. 1218-1219.

[19] B. Schneider and others, "Exposure to di-(2-ethylhexyl)
phthalate in infants receiving extracorporeal membrane
oxygenation," NEW ENGLAND JOURNAL OF MEDICINE Vol. 320, No. 23
(1989), pg. 1563; T.J.B. Gray and S.D. Gangolli, "Aspects of
testicular toxicity of phthalate esters. ENVIRONMENTAL HEALTH
PERSPECTIVES Vol. 65 (1986), pgs. 229-235.

[20] Laura S. Hillman and others, "Identification and measurement
of plasticizer in neonatal tissues after umbilical catheters and
blood products," NEW ENGLAND JOURNAL OF MEDICINE Vol. 292, No. 8
(February 20, 1975), pgs. 381-386.

Descriptor terms: pvc; plastics; medical devices; precautionary
principle; dehp; plasticizers; vinyl institute;