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#662 - Precaution and PVC in Medicine, Pt. 2, 04-Aug-1999

As we saw last week, the chlorine industry needs to expand the
production of polyvinyl chloride plastic (PVC, or "vinyl") to
maintain the profitability of chlorine production. As other
high-volume chlorinated chemicals (such as pesticidal DDT and
ozone-depleting CFCs) are phased out because they are toxic,
long-lived and dangerous to living things, the chlorine industry
hopes to expand the uses of PVC plastic as a profitable "sink"
for surplus chlorine.

However, there is mounting pressure to phase out PVC itself
because it is a bad actor in at least two major ways: (1) burning
PVC in building fires, or in waste incinerators, releases dioxin,
one of the most toxic chemicals ever identified, and (2) soft PVC
products are made soft by the addition of phthalates (pronounced
"thalates"), a class of toxic chemicals that causes a variety of
health problems in laboratory animals. (See REHW #603, #661.)

The current concern about soft PVC products is their use in
medical supplies and equipment. Approximately 25% of medical
plastics are made from soft, phthalate-containing PVC, including
intravenous (IV) bags, blood bags, tubing, gloves, and catheters.
Phthalates can leach out of the plastic into fluids that end up
in patients. As a result, many patients are exposed to levels of
phthalates that have been shown to cause health problems in
monkeys and other animals.

A large coalition of health care advocates, called Health Care
Without Harm (HCWH) is asking hospitals, physicians, and nurses
to apply the principle of precautionary action to medical uses of
soft PVC products.

The precautionary principle says, (1) people have a duty to take
anticipatory action to prevent harm; and (2) the burden of proof
of harmlessness of a chemical lies with the proponents, not with
the general public; and (3) people using a particular toxic
chemical have an obligation to examine a full range of
alternatives.

To apply the precautionary principle to medical uses of soft PVC,
the debate cannot focus on how much exposure to phthalates is
safe (which is a "risk assessment" question). Instead, the debate
must center on finding safer substitutes.

Safer substitutes would include those that do not leach toxicants
and do not create dioxin when burned. Comparative risk assessment
can make a useful contribution to identifying preferable
substitutes.

A careful examination of alternatives is precisely what the
chlorine industry seeks to avoid. Their primary strategy has been
to bog down the debate in interpretations of the toxicological
evidence -- the "dueling risk assessments" strategy invented long
ago by the tobacco industry.

The main front group for this strategy has been Elizabeth
Whelan's American Council on Science and Health (ACSH). ACSH
receives 76% of its funding from industry sources, including
Exxon, the largest phthalate manufacturer in the world.[1]

ACSH hired Dr. C. Everett Koop, Ronald Reagan's Surgeon General,
to spearhead ACSH's "blue ribbon" panel of 17 "experts," most of
whom have ties to the chemical industry, examining PVC safety.
Koop and ACSH concluded that vinyl toys and medical devices are
not harmful.

In its extensive critique of Koop's study, Health Care Without
Harm pointed out that ACSH only weighed the risks and benefits of
medical products made flexible with DEHP (a toxic phthalate --see REHW
#661), while ignoring the available alternatives --cost-competitive
nonPVC products that are perfectly good
substitutes. For instance, Koop said, "removing the phthalate
[from the PVC product] would actually pose a significant health
risk to individuals who depend on these devices [IV bags]." Koop
ignored the fact that an FDA-approved phthalate-free IV bag
produced by McGaw already has about 20% of the IV bag market.[2]

With safer alternatives available, how can anyone justify exposing
patients to a chemical of dubious safety like DEHP, which the U.S.
Environmental Protection Agency [EPA] classifies as a probable human
carcinogen?

In a recent study, the Center for Sustainable Production at the
University of Massachusetts Lowell found readily available
alternatives for most PVC medical equipment: "A review of the
literature, coupled with supplier interviews, suggests that PVC
alternatives are widely available for use in most medical devices
and can be cost-competitive. Several U.S. and European medical
device manufacturers already have developed government approved
PVC-free alternatives for IV bags, tubing, and platelet storage,
some of which command a substantial share of their product
market."[3]

Under the precautionary principle, the onus is on medical device
manufacturers to use the safest alternatives. Baxter Healthcare
recently signed a Memorandum of Understanding with shareholders
who had filed a resolution asking the company to phase out
PVC.[4] According to the Memo, Baxter is "committed to exploring
and developing alternatives to PVC products and to developing and
implementing proposed timetables for substituting its current
containers for intravenous ("IV") solutions with a container that
does not contain PVC.... In the future, Baxter will update the
shareholders on the steps to be taken towards replacing its
global line of PVC-containing products other than IV containers
with non-PVC alternatives." ab As indicated above, the
transition away from PVC will occur more rapidly with some
medical products than others.[5] Baxter has already eliminated
PVC in applications such as blister packaging and drip chambers.
The company began to produce non-PVC IV bags as early as 1975,
when it introduced a PVC-free platelet container. Soon a
polyolefin (PVC-free) bag was developed for use with antibiotic
formulations.[6] The search for alternatives appears to have
accelerated recently, most likely due to PVC-free market
pressures. In 1997, Baxter acquired Bieffe, a European
manufacturer of PVC-free IV bags.

Although Baxter is seeking alternatives to PVC, it continues to
defend the material. K.Z. Hong, Baxter's technical director, says
PVC "has more than 40 years of safe and effective clinical use
working in its favor." If that is true, then why did Senate
Majority Leader Trent Lott in 1998 try to re-write product
liability laws to exempt Baxter from lawsuits? The WASHINGTON
POST reported that the "last-minute Baxter exemption" would have
protected the company from "lawsuits that consumers could bring
against makers of defective and dangerous products." Baxter
spokeswoman Deborah Spak told the POST the company had been
seeking an exemption for IV bags for more than a year, because
"some of our suppliers had indicated they had concerns about
continuing to supply us" if they were not exempted from
lawsuits.[7] As Baxter has acknowledged, "in the past 35 years
approximately 5 billion patients have experienced exposure to
DEHP in the one-to-ten milligram per day range for one to ten
days per year. An additional 3 million patient years of chronic
exposure at 5 milligrams per day, for one to ten years per
patient, have also been accumulated."[8]

No one is suggesting that essential medical devices be yanked out
of patients' arms before safe substitutes are available, which is
why the shareholders asked Baxter to produce timetables for the
elimination of PVC from its products.

Health and environmental considerations are generating
competitive pressures within the chemical and plastics industry
which will likely lead to a broader phase-out of PVC. Exxon is
already phasing out its North American PVC business and investing
in new-generation metallocene polyolefins -- the polymer expected
to substitute for flexible, phthalate-containing PVC in a variety
of applications. As PLASTICS NEWS recently reported from Flexpo
99, the annual flexible polymers conference, cost-competitive
specialty non-PVC polymers are beginning to challenge PVC in
medical, film and sheet, wire and cable, roofing membranes and
other markets. As one industry official put it, "As polymer
scientists, we may feel these trends may not always be based on
sound scientific evidence, but we have to accept that public
concerns about health play a more and more important role in the
marketplace."[9]

While the medical device debate is important, the vast majority
of phthalates -- the most widespread pollutants on the planet --are
used in other applications, including many building
materials. (See REHW #603.) In order to solve the many
environmental problems posed by PVC (including the spread of
dioxin, phthalates and other additives) governments must develop
broad-based materials policies to aid (and, if necessary, force)
businesses to develop and select safer alternatives. (Without
governments to establish a level playing field, corporations that
cut corners on environmental values gain an unfair advantage in
the marketplace, inducing competitors to cut the same corners.)

In Europe, specific materials policies against flexible PVC are
beginning to emerge. For instance, in late June, a sustainability
report by the German Federal Environmental Agency (UBA)
recommended the phase-out of soft PVC.[10] This followed a recent
proposal by the Danish Government to restrict and tax the use of
PVC. In addition, the UK Department of Environment, Transport and
the Regions recently published a buyers' and suppliers' guide,
which advises against the use of PVC. The second environmental
assessment report by the European Environmental Agency (EEA)
lists various problems with PVC.[11]

During the past year, several large companies such as Nike have
pledged to phase out PVC. Others include Visa International
(which issues 580 million plastic credit cards each year),[12]
Firestone (one of the nation's largest manufacturers of roofing
products)[13] and large communications firms such as German
Telekom and Nippon Telegraph and Telephone.

If we can get people better materials for sneakers and credit
cards, shouldn't doctors and nurses be able to provide their
patients with the safest materials available?

The question of what to do in the face of uncertainty regarding
harm from toxic exposures cannot be solved by science alone. It
also requires ethical motivation and common sense.

--by Charlie Cray

=====

[1] Mark Megalli and Andy Friedman, MASKS OF DECEPTION: CORPORATE
FRONT GROUPS IN AMERICA (Washington, D.C.: Essential Information,
1991). See also: "Public-Interest Pretenders," CONSUMER REPORTS
(May 1994), pgs. 316-320. For an excellent review of ASCH's ties
to the chemical industry and Koop, see: "The Junkyard Dogs of
Science," and "Flying the Koop: A Surgeon General's Reputation On
the Line," PR WATCH Vol.5, No. 4 (Fourth Quarter 1998), pgs. 1-6.
Available at: http://www.prwatch.org/98-Q4/dogs.html .

[2] Health Care Without Harm, "Press Release: Clean Bill of
Health, or Misdiagnosis?, Health Care Without Harm Questions ACSH
Report's 'Confidence' in Phtalates." (June 22, 1999). Available
at: http://www.noharm.org/062299_response_to_ACSH.htm .

[3] 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.

[4] "Memorandum of Understanding between Baxter International and
Shareholders," (March 5, 1999).

[5] Bruce Japsen, "Abbott Shareholders Vote Down Bid to Phase Out
Use of a Plastic; Critics Say PVC May Lead to Health Problems,"
CHICAGO TRIBUNE (April 26, 1999), pg. C3.

[6] David V. Bacehowski, Vice-President Advanced Technology
Development, Baxter Healthcare, "Overheads: Non-PVC Product
Development." Date unknown.

[7] Caroline E. Mayer and Helen Dewar, "Foes Cry Foul At Lott's
Amendment To Liability Bill," WASHINGTON POST (July 9, 1998), pg.
E1.

[8] Therese Riesterer, Product Information Associate, Baxter
Healthcare Corporation, letter to Tim Washborn, Mercy Hospital
Healthcare, Rancho Cordova, Calif., June 13, 1997.

[9] Frank Esposito, "Contenders make move on vulnerable PVC,"
PLASTICS NEWS (July 5, 1999), pg. 12.

[10] Umwelt Bundes Amt (UBA), "Fields of action and criteria for
a precautionary, sustainable materials policy exemplified by
PVC," (June 24, 1999). Short version in German available at:
http://www.umweltbundesamt.de/uba-info-daten/daten/pvc.htm .

[11] European Environment Agency, Environment in the European
Union at the turn of the century. (Copenhagen: European
Environment Agency, 1999). Available at: http://www.eea.eu.int/-
frdocu.htm .

[12] "Visa International Approves PETG for Use in Credit Cards,"
MODERN PLASTICS (April 1999).

[13] "Firestone UltraPly TPO Halogen-free Roofing Membrane,"
ENVIRONMENTAL BUILDING NEWS, Vol. 8, No. 5 (May 1999), pgs. 9-10.

Descriptor terms: pvc; chlorine; dehp; phthalates; health care
without harm; plastics; medical devices; plasticizers;
precautionary principle;