P.S. A section of the original posting was chopped when I received it...
sorry!
_______
American Medical News, April 26, 1999
"What's in the Vinyl Bag?"
Take the sniff test. Pour solution from a polyvinyl chloride IV bag into
a cup and solution from a non-PVC bag into another cup. See if you can
smell the difference.
Although not scientific evidence of a problem, the striking odor given
off by the solution from the vinyl bag dramatizes a growing concern of
many physicians, hospitals and health care workers. They are asking
whether phthalates in PVC, which leach into IV solutions and blood
products, pose a health risk.
Health care runs through half a billion IV bags a year, and 80% of them
are made of PVC. The phthalates used to soften the PVC bind loosely with
the hard plastic and therefore leach out, in varying degrees, depending
on the liquid, storage and other factors.
Di-ethylhexyl phthalate (DEHP) is the softener used to make most vinyl
IV bags, tubes and catheters. The evidence is far from conclusive, but
an increasing number of studies show that this toxic chemical can damage
the heart, liver, kidneys and reproductive system of lab animals, and
cause cancer and endocrine disruption. Based on such studies, the
Envronmental Protection Agency has classified DEHP as a "probable human
carcinogen".
Furthermore, incinerating PVC creates dioxin, making health care a
significant dioxin polluter and leading Oakland, Calif., and San
Francisco to pass anti-PVC resolutions in February. Some 25% of plastic
medical products are made with PVC, and the growing use of disposable
products is increasing health care's reliance on vinyl.
For years, vinyl manufacturers have defended PVC, saying it has a long,
safe track record.
Nevertheless, the controversy is mounting, and physicians are
increasingly being drawn into the fray as their patients ask about vinyl
health care products, cities consider PVC bans, medical associations
debate resolutions that call for studying alternative materials and
hospitals initiate non-PVC purchasing policies. A remarkable exmaple of
the growing pressure surrounding this sensitive issue was Baxter
International's April 6 agreement to establish a "timetable to replace
its current containers for IV solutions with an IV container that does
not contain PVC". Baxter and Abbott split the huge, lucrative market for
vinyl IV bags and solutions.
The Interfaith Center on Corporate Responsibility representing
institutional shareholders pushed Baxter into this position. The
coalition threatened to include in Baxter's 1999 proxy statement a
resolution calling on the company to phase out production of medical
products containing PVC. Health Care Without Harm
(http://www.noharm.org), an organization working against vinyl IV bags
that incudes the American Public Health Association, and more than 40
hospitals- many of whom are moving away from PVC- also brought pressure.
In exchange for dropping the resolution, Baxter agreed to phase out PVC
worldwide. Yet the day after this change, Baxter spokeswoman Deborah
Spak said the statement represents "no change" and that the company
"still stands behind PVC"-- even though it now plans to "ultimately
stopnusing PVC for IV bags". Such spin may be designed to avoid
potential liabilities and alarming the public or analysts. Last year,
Baxter generated more than $2 billion in sales of IV products.
Meanwhile, Abbott shareholders included an anti-PVC resolution in its
1999 proxy statement, assuring the question a hearing at the annual
shareholders meeting in April.
Providers face similar challenges. Resolutions against purchasing PVC
products will be addresses this spring at shareholders meeting of the
nationa's largest health care systems, Columbia/HCA and Universal Health
Services.
Risks and alternatives.
Although the potential health risks of DEHP are heatedly debated, the
fact that DEHP leaches significantly is not. The Food and Drug
Administration does not allow many drugs, including anti-cancer agents
Taxol and Taxotere, to be packages in PVC bags because of leaching.
Ironically, red blood cells stored in PVC bags have a longer shelf life
due to the interaction with DEHP.
The question, rather, is how much DEHP leaches into various solutions
and whether that presents a long-term health risk. Clearly, patients are
not in immediate danger and health care should not abandon vinyl
products overnight. But long term, collective effects in humans have not
been adequately studied.
There are plenty of alternatives to DEHP-laden PVC. Nonvinyl IV bags are
common in Europe, where some countries have restricted the medical use
of PVC and DEHP. Recently, Baxter acquired a European manufacturer if
non-PVC bags.
In this country, McGaw launched a nonvinyl bag about 10 years ago. The
fact that the company has captured "only" about 20% of the U.S. market
for IV bags is "proof of superiority of PVC", says the Chlorine
Chemistry Council. But McGaw, which insists that its bag is
competititvely priced, says it has been unable to win more business
because competitors can offer better deals based on volume discounts and
broad product lines. Indeed Baxter and Abbott lock up huge amounts of
business with multi-year, multiproduct, single-source contracts.
Is health care's dependence on vinyl based on a certainty that PVC holds
no health risks, or is it based on the market clout of giant
manufacturers who don't want to face a multimillion-dollar retooling
effort?
This question and the safety of PVC should be thoroughly examined. The
first to take a swing at it will be the American Council on Science and
Health (http://www.acsh.org), which recruited C. Everett Koop, MD, ScD,
to head up a panel to review the literature. ACSH's report is due in
June, but don't expect the group to rule against vinyl. Instead, look
for phthalates to constitute the newest chapter in ACSH's treatise,
Facts Versus Fears: A Review of the Greatest Unfounded Health Scares of
Recent Times, which includes chapters on DDT and Love Canal.
Meanwhile, the FDA is revisiting the issue, with a report due this
summer. But don't expect a call for change from the agency that has
contributed much to the barriers to entry that happen to benefit Baxter
and Abbott.
Another study is being conducted under the auspices of the Chemical
Manufacturers Assn (http://www.cmahq.com), which has committed $1.2
billion over the next six years to research the health and safety of
chemicals. This includes testing the toxicity of 8,000 commonly used
chemicals and whether they pose a threat to human endocrine systems. CMA
says the research will be independent and peer-reviewed.
Meanwhile, in August the EPA will begin a multibillion-dollar screening
and testing of thousands of chemicals for potential hormone disruption.
These latter two projects are the most pertinent to overall public
health issues because they will look beyond healthcare and examine the
potential risks of cumulative, lifelong exposure to vinyl. Significant
amounts of plasticizers, for example, leach into food from PVC wrap used
and sold ny supermarkets, according to a recent Consumer's Union study.
And last Christmas a dozen manufacturers were pressured into pulling
from the market infant teethers, rattlers and toys- even pacifiers and
baby bottle nipples- that were made from vinyl softened with phthalates.
Given the increasing levels of cradle-to-grave exposure to PVC and other
plastics in and out of health care, it's time to find out which ones are
safest for medical use and the public health.