Baxter's reply to ANA, HCWH, .. on PVC iv phase-out

[ttweed@wildrockies.org (Tony Tweedale)]

Date:         Fri, 07 May 99 19:21:16 EDT
From:         "C" <thclax00@UKCC.uky.edu>
Subject:      Re: INFOTERRA: Baxter Medical to phase out vinyl IV bags (fwd)
To:           ttweed@wildrockies.org
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----------------------------Original message----------------------------
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Date: Sat, 8 May 1999 00:28:34 +0100
To: "C" <thclax00@UKCC.UKY.EDU>
From: Ferdinand Engelbeen <Ferdinand.Engelbeen@ping.be>
Subject: Re: INFOTERRA: Baxter Medical to phase out vinyl IV bags
Cc: infoterra@cedar.univie.ac.at

Here follows the answer of Baxter themselves on the statements of
Greenpeace, ANA and others.

Sincerely,

Ferdinand Engelbeen
Chairman Chlorophiles

---------

Baxter International Inc.
8 April 1999


      Baxter Reiterates Company's Position Regarding PVC

      We are profoundly disappointed in the misrepresentations that have
been made in recent
      days concerning Baxter's materials development efforts and its use of
polyvinyl chloride
      (PVC) in its products. The recent statements made by activist groups
are inaccurate.

      Earlier this week, Baxter International Inc. and three institutional
shareholders -- the
      Retirement Plans for the Employees of the Sisters of Mercy Regional
Community Center
      of Detroit, the Sisters of Charity of Cincinnati and the Service
Employees International
      Union (SEIU) Master Trust -- jointly announced an agreement that
seeks to clarify
      Baxter's ongoing and future plans for research and development of
additional medical
      products with non-PVC materials through the establishment of a
timetable and
      benchmarks.

      Specifically, the Memorandum says, "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 solutions
with a container that does
      not contain PVC."

      Baxter simply views this non-binding agreement as an opportunity to
promote the
      materials development efforts it has already had in place for many
years.

      As stated in the April 6 press release, Baxter continually evaluates
a variety of materials
      and allocates significant funding for the research and development of
biomaterials.
      Continuing its decades-long efforts in the field of materials
research and development,
      Baxter plans to develop and introduce many products over the next
decade that use a
      variety of materials. Baxter already offers more than a dozen vital
medical products that
      use alternative materials, including blood platelet storage
containers, empty containers
      for compounding pharmaceutical and nutritional solutions, and such
premixed
      medications as Ancef® , Pepcid®, Rocephin® and Vancocin®.

      Our Viaflex® container has been the industry standard for intravenous
solutions for
      nearly 30 years because of its excellent safety and performance
record. As any smart
      company does, we are always looking to obsolete our own products and
offer our
      customers additional features. We continue to explore and develop
materials that will do
      just that -- provide superior safety and performance and offer even
greater optical clarity,
      efficiency and ease of manufacturing. That these materials do not
contain PVC has
      nothing to do with the unwarranted concern raised by activist groups
regarding the safety
      of PVC.

      In many applications, PVC remains the material of choice because of
its long history of
      safe use, and because of its outstanding performance characteristics.
In instances where
      the overall performance and safety of another material is proven
superior to PVC and
      regulatory clearance is obtained, we will offer alternatives to our
customers.

      Medical products containing PVC have undergone strict regulatory
review by many
      government and independent health agencies throughout the world,
including the U.S.
      Food and Drug Administration (FDA). Hundreds of studies have
confirmed the safety of
      this material in medical applications. Health Canada has stated that
it, "has found no
      potential risk for patients in using blood products or IV solutions
from PVC bags." The
      director of the FDA's Center for Devices and Radiological Health said
last month, "We
      believe that IV bags, blood administration sets and the other uses of
PVC, including
      dialysis tubing are safe."

      Health-care providers and their patients are best served by a
reasoned, science-based
      approach in the development of medical products. That is the approach
that we have
      always taken, and the approach we have shared with these shareholders.

      We plan to remain a pioneer in materials research and we will
continue to provide our
      customers with products made from the most appropriate materials,
taking into careful
      consideration the unique characteristics of the solutions going into
the containers, the
      performance characteristics required, and scientific data.

---------------
Original message:


>              IV Products Manufacturer to Phase Out Vinyl IV Bags
>
> American Nurses Association
> 600 Maryland Avenue, S.W., Suite 100-West
> Washington, DC 20024-2571
>
> FOR IMMEDIATE RELEASE April 6, 1999
>
> CONTACTS: Michael Stewart, 202-651-7048
> Michelle Slattery, 202-651-7027
> e-mail: RN=RealNews@ana.org
> webpage: www.nursingworld.org/rnrealnews/
>
> Responding to Public Concern, Nation's Largest IV Products Manufacturer to
> Phase Out Vinyl IV Bags
>
> WASHINGTON, DC -- The nation's leading producer of intravenous (IV) bags,
> Baxter International Inc., today announced a commitment to develop
> alternatives to polyvinyl chloride or PVC for their products, including IV
> bags.
>
> More than 500 million IV bags are used in the United States every year to
> deliver blood, medication and other essential fluids to sick and injured
> patients. Eighty percent of these are made of PVC. These vinyl IV bags have
> been shown to leach the toxic chemical di-ethylhexyl phthalates (DEHP) into
> the solutions they contain.
>
> The announcement comes in the wake of mounting public pressure to eliminate
> patients' needless exposure to dangerous chemicals such as DEHP when safe,
> cost-competitive alternatives exist. The company negotiated with public
>health
> advocates from the Interfaith Center on Corporate Responsibility, a faith
> based North American coalition, and Health Care Without Harm (HCWH), an
> international campaign of 41 hospitals and more than 130 other health and
> environmental organizations, including the American Nurses Association.
>
> The health risks associated with vinyl IV bags recently garnered
>international
> attention when HCWH launched a highly visible public education campaign
>around
> this issue.
>
> Plastic PVC products require a softener to make them flexible, which is why
> they are manufactured with DEHP. DEHP, shown to leach out of the vinyl IV
> bags, has been classified by the EPA as a probable human carcinogen. Studies
> have shown that DEHP can damage the heart, liver, testes and kidneys and
> interfere with sperm production.
>
> "The medical ethic is 'first, do no harm,'" said Charlotte Brody, R.N.,
> Co-Coordinator of HCWH, and a member of the South Carolina Nurses
>Association.
> "We applaud Baxter's decision to reduce the risk of harm by removing PVC from
> IV bags."
>
> In addition to disclosing the susceptibility of patients to DEHP
>exposure, the
> coalition noted that vinyl IV bags also have a high chlorine content.
> Consequently, vinyl manufacturing and disposal by incineration create dioxin
> -- one of the world's most toxic chemicals.
>
> "I welcome Baxter's initiative. I think it is appropriate that a medical
> device manufacturer should use the precautionary approach to avoid the
> problems of PVC given the availability of alternatives. I plan on watching
> closely how it develops in practice over the next several years," said Dr.
> Peter Orris, Professor of Preventive and Internal Medicine at the University
> of Illinois School of Public Health. Dr. Orris is the American Public Health
> Association's representative to HCWH.
>
> Baxter did not specify when the phasing out process would be completed.
>
> The potential dangers of PVC products may be news to the general public, but
> it's not to some in the medical community.
>
> In fact, certain medications, including the chemotherapy drugs Taxol and
> Taxotere, come with warnings against using PVC equipment for their
> administration. In addition, Abbott Laboratories, another large manufacturer
> of PVC IV bags, warn that these products have not been tested for
> carcinogenicity, mutagenicity or fertility effects, and that children and
> nursing mothers should be particularly cautious when using the product.
>
> Alternatives to vinyl plastics are increasingly being used in Europe,
> particularly in Austria and Germany. (Baxter recently purchased Bieffe, a
> Swiss maker of non-PVC IV products.)
>
> Baxter's decision to phase out PVC IV bags came despite attempts by chemical
> trade associations to refute claims that these devices needlessly expose
> patients to toxic chemicals.
>
> Their claims, however, are largely unsubstantiated. For example:
>
> CLAIM: Substitutes for vinyl are untested. FACT: Twenty percent of the IV
> market in the U.S. already uses cost-competitive, FDA-approved non-vinyl
>bags.
>
> CLAIM: The Consumer Product Safety Commission exonerated DEHP. FACT: The
> agency asked the toy industry to remove DEHP from teething toys in 1986, due
> to concerns about its toxicity and its ability to leach into children's
> mouths.
>
> CLAIM: There is no scientific evidence of risk to humans from DEHP exposure.
> FACT: Damaging effects of DEHP have been demonstrated in peer-reviewed
>studies
> of dialysis patients, as well as in animal studies that are designed to gauge
> safety or risk to humans. DEHP has also been found in the blood, brain and
> liver of premature infants who received respiratory therapy through PVC
> tubing.
>
> Chlorine and vinyl industry associations also claim that the quality of
>health
> care will decline if vinyl medical products are replaced. To the contrary,
> HCWH contends that eliminating needless exposures to DEHP and dioxin actually
> improves public health, without increasing costs.
>
> Health Care Without Harm has more than 170 member organizations,
>including the
> American Nurses Association, 41 hospitals, such as Beth Israel Medical
>Center,
> New York; New England Medical Center; and the hospitals of Catholic Health
> Care West. Other members include the Oncology Nursing Society, American
>Public
> Health Association, Breast Cancer Fund, Endometriosis Association,
>Greenpeace,
> the Sierra Club and many other environmental and social action organizations.
>
> ###
>
> ATTENTION JOURNALISTS: For more information about Health Care Without Harm or
> the dangers posed by polyvinyl chloride (PVC) IV bags, please contact Laura
> Burstein at 202-822-5200, extension 222. To review previous ANA action on PVC
> and DEHP, visit our "RNnoharm" webpage: http://www.nursingworld.org/rnnoharm/
>
> ###
>
> The American Nurses Association is the only full-service professional
> organization representing the nation's 2.6 million Registered Nurses through
> its 53 constituent associations. ANA advances the nursing profession by
> fostering high standards of nursing practice, promoting the economic and
> general welfare of nurses in the workplace, projecting a positive and
> realistic view of nursing, and by lobbying the Congress and regulatory
> agencies on health care issues affecting nurses and the public.
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-----------------------
Ferdinand Engelbeen
Chairman Chlorophiles
Oude Ertbrandstraat  12
B-2940 Stabroek
Belgium
E-mail Chlorophiles@ping.be
Web-site: http://www.ping.be/chlorophiles/