Fw: #662: Precaution and PVC in Medicine, Pt. 2

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>=======================Electronic Edition========================

>. .

>. RACHEL'S ENVIRONMENT & HEALTH WEEKLY #662 .

>. ---August 5, 1999--- .

>. HEADLINES: .

>. PRECAUTION AND PVC IN MEDICINE, PT. 2 .

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>

>PRECAUTION AND PVC IN MEDICINE, PT. 2

>

>by Charlie Cray

>

>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

>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, 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. " \tab 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.

>

>==============

>[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] 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] 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] 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;

>

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