Introduction

Improving health care is one of the greatest challenges facing society today. Although few nations deliver finer quality health services than the United States, Americans understandably worry about both cost and access. This challenge is made difficult for a variety of reasons: high levels of regulation, issues of health insurance, frivolous lawsuits, the high cost of developing new products, and, increasingly, an aggressive environmental ideology that often places political goals ahead of patient care. Unfortunately, in their campaign against the health industry, proponents of ideological environmentalism have often won support among those of religious faith.

One such example of this partnership between ideological environmentalists and religious believers is the work of Health Care Without Harm (HCWH). Its campaign specifically desires “to transform the health care industry worldwide, without compromising patient safety or care, so that it is ecologically sustainable and no longer a source of harm to public health and the environment.”¹ Central to its efforts in the past has been the elimination of mercury and, most recently, of medical products made of polyvinyl chloride (PVC) plastics.

Fundamental to carrying out HCWH’s mission have been its extensive partnerships with the religious community. It has drawn members from numerous mainline churches, such as the General Board of Church and Society of the United Methodist Church, New York’s Cathedral of St. John the Divine, and the Presbytery of New York City (made up of ninety-nine Presbyterian congregations). Furthermore, HCWH is allied with the Interfaith Center for Corporate Responsibility (ICCR), an agglomeration of 275 religious institutional investors. The campaign’s most obvious success has been its partnership with Catholic Health Care West, a member group that has pledged to phase out the use of PVC medical products.

In general, the environmental activism of many Christians stems from the positive role assigned to humans in stewarding creation’s resources wisely. The Book of Genesis reveals to the believer the special role of humankind in caring for creation and making its resources productive. In this regard, Pope John Paul II has remarked that the Genesis account reminds the faithful “…that this brings concrete obligations in the area of ecology for every person.”² And these obligations should not be ignored.

In addressing these “concrete obligations,” however, some Christians, especially those in partnerships with secular environmental groups, have adopted attitudes that undermine, by effect if not by intention, the fundamental Christian commitment to the inviolable dignity of the human person that is concretely expressed in the work of providing health care. This is particularly true in the area of health care policy, when it is understood as part of a broader agenda of environmental activism. Therefore, Christian activists in the area of environmental and health policy should carefully grasp and understand the theological, philosophical, and moral assumptions and consequences of their efforts. Too often, however, religiously motivated programs of enviro-health policy activism fail to engage in such wide-ranging, critical reflection on these important points.

Because not all environmental and health policy issues receive significant public attention, certain activist programs involving important repercussions for matters of health care can be easily missed. Many of these are not fought exclusively or even primarily in the traditional arenas of public policy debate; rather, they are often done at the grassroots level. So it is with the PVC—or, more simply, vinyl—debate. PVC is a critical component of important medical devices, such as dialysis tubing, endotracheal tubes, iv bags, mattress covers, oxygen tents, and surgical gloves. Building materials ranging from flooring to wiring also include vinyl. Vinyl products gain their flexibility through the use of plasticizers. The most common plasticizer used in vinyl medical devices is di(2-ethylhexyl) phthalate, or DEHP. Phthalates are a family of chemical compounds that have a certain similarity of appearance and structure and perform many different tasks. About 80 percent of the phthalates manufactured today are used to make plastics flexible, without sacrificing strength or durability.

The benefits of these products are obvious. However, aggressive ideological environmentalists, in partnership with religious organizations, are campaigning to eliminate PVC, which could have the effect of sacrificing patient care for political ends. Although HCWH as an organization is formally dedicated to improving patient health, many of its constituent members seem more interested in pursuing ideological, or perhaps even religious, goals.

Few human activities are without risk; yet secular and religious enviro-health activists have grossly exaggerated the potential problems of vinyl products. For instance, the incineration of products containing PVC can generate dioxin, a particularly feared carcinogen. In laboratory experiments heavy exposure to DEHP has harmed mice and rats. However, the impact of medical waste on dioxin emissions is minuscule and falling. And most scientists agree that DEHP poses only a theoretical risk to a small number of particularly sensitive patients who experience the greatest DEHP exposure.

Thus, prudent policy and sound science suggest reducing unnecessary vinyl exposure for uniquely vulnerable populations, particularly for babies receiving intensive medical procedures. However, most uses of PVC are perfectly safe for most people. An agenda that would lead to the abandonment of vinyl products would simultaneously increase costs while degrading care. In short, the attempt to achieve perfect safety by banning PVC would inevitably create greater risks elsewhere—hardly a desirable situation for those interested in preserving human health.

The specific program of enviro-health policy activism proposed by HCWH is problematic on four important points:

• Confusion about Christian notions of anthropology

• Misunderstanding about humanity’s role in stewarding creation’s resources

• Ambivalence about the positive goods of technological advancement in the service of human health

• Over-application of the precautionary principle based on inconclusive science

The Benefits of Vinyl

No product or technology is indispensable, but PVC has proven to be a boon to human health—especially to those administering or receiving health care. Products made from vinyl are often less expensive than competing products—an important consideration at a time when virtually every doctor, hospital, employer, insurer, and government agency is desperately attempting to cut expenses.

Moreover, vinyl-based health care products, which account for roughly a quarter of the total plastics used in medicine today, offer unique advantages. PVC is a versatile product that can be used in dramatically different applications, from building materials to dialysis equipment. Also, when plasticized, it is pliable and can be shaped and arranged to fit very specific requirements. PVC tubes don’t easily form kinks, which can stop or restrict the flow of critical fluids to patients. Blood and iv bags made from PVC collapse naturally, helping to expel their contents. Vinyl promotes durability and resilience, discouraging chemical-stress cracking and allowing for extended use in demanding applications. PVC products offer clarity and transparency, allowing for continual monitoring of fluid flow—another critical advantage. Vinyl can be sterilized and recycled. Vinyl won’t break, in contrast to glass products. PVC blood bags even extend the useful life of blood since the additive DEHP acts as a preservative; blood can be stored for forty-two days in a vinyl bag, compared with only twenty-one days in a glass bottle or in other plastics.

The pervasiveness of flexible vinyl products attests to their value: blood bags, catheters, connectors, cushions, dialysis equipment, drip chambers, ear protectors, gloves, goggles, health worker caps, IV bags, lab equipment, masks, mouthpieces, oxygen masks, packaging materials, seals, splints, surgical wire, thermal blankets, tubes for multiple purposes, and valves. Plasticizers such as DEHP provide the flexibility to meet these diverse applications. Former Surgeon General C. Everett Koop warned, “Without DEHP, a wide range of life-saving medical devices—such as blood bags, catheters (cardiac and urinary) and a variety of surgical instruments and gadgets—would lack either the flexibility, transparency, or shelf life to be of much use.”³ A seventeen-member advisory panel chaired by Koop explained that “DEHP confers considerable benefits to certain medical devices and procedures, and its elimination without a suitable substitute could pose a significant health risk to some individuals.”⁴

Dr. Kenneth Green of Canada’s Fraser Institute has studied the vast use of vinyl medical products. He figures that “nearly one-third of the population derives a health benefit from [PVC products] in any given year.”⁵

The HCWH Campaign Machine

HCWH was founded in 1996 by a number of left-leaning environmental groups; it has since expanded to some 350 members, including labor and, most significantly, religious organizations. Participants range from traditionally liberal organizations, such as the Maryland Public Interest Research Group, to radical activist groups, such as Greenpeace. There are even foreign members, such as the Bangladesh Environmental Law Association.

However, HCWH has won influence by picking up some important medical allies, particularly New England Medical Center in Boston, Beth Israel Health Care System, Kaiser Permanente, Physicians for Social Responsibility and Mt. Sinai School of Medicine in New York, and Catholic Health East and Catholic Healthcare West—the latter two made up of numerous Catholic institutions. Other members include the American Nurses Association and Marin Breast Cancer Watch.

Since the use of PVC plastics in medical care hardly seems to be a religious issue, one may wonder why so many prominent religious groups are interested in this campaign. One reason is that these groups are simply following a pattern of greater religious involvement in various programs of enviro-health policy activism. Because of this, it would appear that these groups are motivated by what they feel to be legitimate enviro-health policy concerns. Also, the fact that churches and other religious groups are large, “ready-made” grassroots organizations is surely not lost on HCWH’s secular partners.

It seems unlikely that all of HCWH’s members share all of its positions. Even more importantly, it is doubtful that most of the members of HCWH’s religious component—church-going Presbyterians in New York City, for instance—know anything about HCWH, let alone support the organization’s positions, given its expansive nature. Although PVC is near the top of its Web site issues list, HCWH also emphasizes incineration, mercury, pesticides, and pollution prevention. Aside from the broad biblical mandate to be good stewards of creation, none of these issues is what could be understood as a traditionally religious issue or even an environmental issue that usually appeals to religious activists.

HCWH has won support from a range of groups, in part, because its objectives are superficially appealing. Although its animating force comes from groups such as Greenpeace, HCWH’s goals are difficult to reject in the abstract. Just as few people oppose a cleaner environment, which is the professed goal of even the most radical environmentalist, few people could oppose the goal of providing health care without imposing harm.

Moreover, HCWH tends to bundle issues together in its lobbying efforts; its sample letter calls for eliminating mercury, reducing wasteful packaging, and recycling garbage, as well as eliminating “the use of PVC plastics.”⁶ Other groups often join to advance only one of its objectives. For example, an organization dedicated to recycling or eliminating mercury might be attracted to HCWH even though it is not concerned about PVC.

Some more moderate HCWH members also fail to focus on the means used to achieve presumptively laudable ends. In terms of vinyl, HCWH has variously charged the product with causing cancer, reducing fertility, damaging infants’ reproductive development, and harming kidneys. Such charges are based on effects observed in rodents exposed to high doses. There is no reliable evidence suggesting that exposure to DEHP has caused these adverse effects in humans. Scientific and regulatory authorities widely acknowledge that the rodent studies upon which the organization relies have limited, if any, relevance to human beings. Basing such wide-ranging and varied claims on only selected studies is both scientifically erroneous and morally questionable.

Nevertheless, the organization is seeking to end the use of PVC products and mandate labeling of any goods that include DEHP.⁷ Further, HCWH is attempting to pressure hospitals, purchasing organizations, and entire health care systems to drop products with vinyl. The group has won supportive resolutions from various medical groups, churches, and cities. It has also lobbied governmental agencies and states, as well as the World Bank. Another tactic has been to advance stockholder resolutions to reduce the use and production of PVC products. The group’s greatest success has come with those least involved in patient treatment. In contrast, the American Medical Association rejected a call to ban PVC products in neonatal intensive care units; instead, the association endorsed working with the FDA in assessing the safety of these devices.

As noted earlier, HCWH has benefited from the involvement of religious groups and the moral legitimacy that they provide. In fact, HCWH’s most obvious success has been its partnership with Catholic Health Care West, which professes its intention to phase out PVC medical products—a decision based more on ideology than on sound science. Yet mere religious participation cannot camouflage the highly political nature of the group’s efforts. To the contrary, this partnership is another example of how religious organizations seem to put their faith in politics, confusing ideology with theology. Similar is the work of the Interfaith Center for Corporate Responsibility (ICCR), which pushes a broad range of standard liberal political causes: the use of expensive renewable energy sources, opposition to oil drilling in the arctic, high executive compensation, high pharmaceutical prices, genetically engineered foods, and discrimination based on sexual orientation. Along with this rather long and very partisan agenda is a call to phase out PVC products.⁸ Some of these may be legitimate public policy issues. None, however, is grounded in what could be understood as orthodox conceptions of theology or morality, as one might expect from religious groups that invoke their creeds in service of programs of enviro-health activism.

Indeed, religion is often but a thin veneer behind which radical groups such as Greenpeace can labor. For Greenpeace, which has long been antagonistic toward virtually any chemical or technology, irrespective of the benefit, the campaign against PVC products is an ideological crusade rather than a campaign for public health.⁹ Otherwise, why would anti-vinyl activists want to ban the use of the product in office equipment, buildings, toys, and electrical cables, where absorption is minimal and even babies are not at risk?

The Problem of Dioxin

Dioxins are a group of related chemical compounds. Some dioxins are classified as known human carcinogens—that is, in high enough concentrations, dioxin can cause cancer in human beings. Dioxin contamination led to the closing of the town of Times Beach, Missouri. Thus, reducing dioxin emissions is excellent public policy. But eliminating use of vinyl products would not materially advance this goal.

There are numerous means of exposure to dioxin. Even HCWH acknowledges that “over 90 percent of our exposure to dioxin is through food, with major sources including beef, dairy products, fish, pork, and breast milk.”¹⁰

Chlorine-based production processes, copper smelters, and even backyard fires also generate dioxin. So do forest fires. HCWH, however, focuses on PVC:

A large body of evidence has found a link between the amount of chlorine entering an incinerator and the dioxin emissions that leave its smokestack. Since PVC is more than 50 percent chlorine by weight, it is a major chlorine “donor” for dioxin formation. PVC products contribute as much as 80 percent or more of the total chlorine fed into medical waste incinerators. The dioxin formed by incinerators ends up in both stack gases and ash residues.¹¹

This is true as far as it goes, but that isn’t very far. First, dioxin pollution is shrinking. Since 1980, dioxin contamination has fallen dramatically, even though PVC production has tripled.¹² Indeed, according to the Environmental Protection Agency (EPA), overall dioxin emissions are down an incredible 92 percent since 1987.¹³ Dioxin pollution from medical waste incineration fell even more over the same period, by 99.7 percent.¹⁴ As the epa explains, this dramatic drop is “primarily due to reductions in air emissions from municipal and medical waste incinerators, and substantial further declines continue to be documented.”¹⁵ Today, the burning of medical wastes accounts for only seven grams toxic equivalency (TEQ) out of a total of 1,106 grams teq emitted in the United States each year, or barely more than one-half of one percent of dioxin pollution. Backyard trash fires, in contrast, contribute more than half of dioxin pollution, or 628 grams TEQ; residential wood burning, diesel trucks, cement kilns, aluminum smelting, crematoria, and a score of other sources all contribute more than does the incineration of medical waste.¹⁶

It makes sense to reduce even that one-half of one percent, but it should be done at a reasonable cost, and that is just what is being done. The EPA has already mandated that incinerators further shrink emissions, a measure expected to cut dioxin emissions by another quarter, to five grams TEQ annually. And the most critical factor in reducing dioxin emissions is improving the design and operating characteristics of incinerators—particularly the temperature at which they operate—not cutting the chlorine content of the garbage.¹⁷ In fact, the EPA stated in its medical incineration regulations that “the effectiveness of a pollution prevention program directed at reducing dioxin emissions through the shifting of waste composition from chlorinated plastics to nonchlorinated polymers would be questionable.”¹⁸ A detailed study by the American Society of Mechanical Engineers “found no statistically significant relationship between chlorine input and PCDD/F stack gas concentrations.” Thus, “discernible changes and consistent improvements in PCDD/F waste combustor stack concentrations are unlikely to be realized by reducing waste chlorine content.”¹⁹

Moreover, many hospitals and health care systems are switching to the use of alternative technologies such as autoclaves—treating materials to high temperature steam under pressure, thus eliminating incinerators and dioxin. California no longer has any incinerators; Michigan has only one. Incinerators are also gradually disappearing from other states—a sure sign that market forces, combined with good environmental policy and technological advancements, have had an impact.

Thus, PVC use today is largely irrelevant to dioxin pollution. Hospitals as well as policy makers should look for additional, cost-effective ways to reduce dioxin emissions. That goal warrants reducing reliance on incinerators and improving the operation of facilities that remain. It does not justify eliminating PVC products entirely.

The Fear of DEHP

Exposure to phthalates is common, though at very low levels. Use of medical devices, however, can result in more concentrated exposure, since the chemical can migrate out of vinyl medical products when they come into contact with blood, plasma, and other solutions. Experiments have demonstrated harm to laboratory animals. Rodents given very high doses of DEHP can experience liver toxicity or reproductive health effects, notably testicular atrophy. ²⁰

However, the risk to humans is slight. PVC products have been used for more than five decades and are estimated to account for up to seven to nine billion patient days of acute use, and one to two billion patient days of chronic use, with no apparent ill effects.²¹ Explains Dr. David Feigal, the former director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA): “We have not received reports of these adverse events in humans,” though he adds that “there have been no studies to rule them out.”²²

Of course, it is hard to prove a negative. But a look at the complete scientific picture, in the opinion of this author and of many scientific reviewers, indicates that potential risks to human from DEHP medical devices are low or non-existent.

An early concern about DEHP was potential carcinogenicity, but the scientific and regulatory communities now have fairly uniformly concluded that DEHP is not a human carcinogen. In 1999, a panel formed under the auspices of the American Council on Science and Health and chaired by C. Everett Koop concluded, “DEHP, as used in medical devices, is not harmful to humans even under chronic or higher-than-average conditions of exposure.”²³ The committee noted that even the research indicating some concern over more sensitive populations typically assumed one hundred times the exposure found to injure rodents.

Furthermore, the likelihood of DEHP being carcinogenic for humans has been dismissed by the Canadian government’s medical agency, Health Canada, and has been questioned by the former head of the EPA’s Science and Policy staff.²⁴ The European Commission ruled that DEHP “shall not be classified or labeled as a carcinogenic or an irritant substance.”²⁵ In a report last year, the European Commission stated, “There are no concerns over carcinogenicity in humans on the basis of animal studies. The general view of DEHP toxicity is therefore that mechanisms for adverse effects do exist in rodents, but that these do not appear to be of great significance in non-human primates and that the evidence that such mechanisms could be operative in humans is lacking.”²⁶

And a review of nearly five hundred studies found no “evidence of hepatocarcinogenicity in population groups that had been exposed to DEHP.” (Hepatocarcinogenicity is a tendency to cause cancer in the liver.) Moreover, it concluded, “considering the available data, an additional cancer risk by DEHP in maximally exposed hemodialysis patients appears unlikely.”²⁷

Most importantly, three years ago, the International Agency for Research on Cancer, part of the World Health Organization, downgraded DEHP from a possible carcinogen to one “not classifiable as to carcinogenicity to humans.” And it did so—only the second time in its history—on the basis that “the mechanism by which DEHP increases the incidence of hepatocellular tumours in rats and mice is not relevant to humans.”²⁸

Although animal studies create cause for more detailed human research, chemicals often have a significantly different impact on animals than on humans. At issue are both “the discordant effects of chemicals on animals and humans” and the relevance of very high lab doses “to low-level exposures in the real world.”²⁹ In the case of DEHP, for instance, a Department of Health and Human Services expert panel at the National Toxicology Program (NTP) that reviewed DEHP studies found that there was less absorption in primates than in rodents.³⁰ And the non-human primates studied are more closely related to humans (which are also primates) than rodents.

However, in the absence of studies on humans, governmental agencies have relied on rodent data to issue their evaluations. With cancer no longer a concern, focus has shifted to the question of whether medical exposure to DEHP can cause reproductive health effects in humans—effects exhibited in rodents given large doses of DEHP. The NTP, FDA, and Health Canada have all weighed in on this issue and have reached similar conclusions, agreeing that while the vast majority of vinyl medical products are safe for the general patient population, there remains concern over the potential for DEHP exposure to cause reproductive toxicity in a few vulnerable patient groups, notably neonates (a baby born prematurely), male fetuses, and males during puberty.

More specifically, in September 2001 the Center for Devices and Radiological Health at the Food and Drug Administration published a report that investigated potential exposures to DEHP versus a “Tolerable Intake” (TI) that the FDA had derived by taking a no-effect level in animal studies and dividing by a safety factor of 100. The FDA reported:

• “Based on the results of the safety assessment, cdrh concludes that there is little to no risk posed by patient exposure to the amount of DEHP released from PVC IV bags following infusion of crystalloid fluids.”

• “The dose of DEHP received by adult patients receiving tpn [total parenteral nutrition] admixtures is estimated to be less than the TI, suggesting that there is little concern for DEHP-mediated effects in these patients.”

• “Relatively high doses of DEHP can be received by patients who are transfused with large volumes of blood and blood products over a short period (e.g., trauma or surgical patients receiving massive transfusions). However, the TI/dose ratio for this procedure is likely to overestimate the actual risk to these patients, since the ti is intended to be protective for long-term exposures, compared to relatively short-term exposure in acute transfusions.”

• “The aggregate dose of DEHP received by adults undergoing cardiopulmonary bypass procedures may equal or exceed the TI in some patients. However, heparin-coated tubing is used in about half of ‘special’ or high-risk cases and about 17 percent of ‘routine’ cases.... Since little DEHP is released from heparin-coated tubing ..., the dose of DEHP received by many patients undergoing cardiopulmonary bypass will be less than those undergoing the procedure where uncoated PVC tubing is used.” (Heparin is a drug used to decrease the clotting ability of the blood and helps to prevent harmful clots from forming in blood vessels.)

• “Based on recent data on the amount of DEHP retained by patients on hemodialysis, there is little concern regarding exposure to DEHP in patients undergoing this procedure.”³¹ (Hemodialysis passes blood through an artificial kidney machine as a treatment to clean the blood of patients who have suffered kidney failure.)

In noting concern for children, relative to adults, the FDA evaluation stated:

• “…children undergoing certain medical procedures may represent a population at increased risk for the effects of DEHP. This decision is supported by three findings: 1) children undergoing some medical procedures receive a greater dose of DEHP, on a mg/kg basis than adults do; 2) pharmacokinetic differences between children and adults may result in greater absorption of DEHP; [and] 3) children may be more pharmodynamically sensitive to the adverse effects of DEHP than adults are.”

This concern, while rightly “health-protective” and “conservative,” by the FDA’s own admission, “likely overestimate[s] the risk to the exposed patient populations.”³²

In July 2000 an expert panel at the NTP Center for the Evaluation of Risks to Human Repro-duction issued its report expressing a “minimal level of concern” about adult exposure to DEHP. And while noting “that the benefits of medical procedures [using vinyl] can outweigh the risks,” the panel expressed “serious concern” in critically ill infants.³³

An example of such care is extracorporeal membrane oxygenation (ECMO), a life-saving procedure in which blood is run continuously through oxygenating equipment connected by vinyl tubing. Exposures due to ECMO in neonates are estimated to be the highest medical-device exposures. Other higher-than-average exposures can occur from total blood transfusions and parenteral nutrition. Parenteral nutrition is one of the ways people receive food when they cannot eat. It is a special liquid food mixture given into the blood with a needle through a vein. The mixture contains all the protein, sugars, fat, vitamins, minerals, and other nutrients needed. As mentioned earlier, it is sometimes called “total parenteral nutrition,” “TPN.” Nevertheless, the FDA estimated that the total exposure of an infant receiving all of these procedures would be below the level that caused no effects in the relevant animal study, although the exposures would be above the TI.³⁴

The expert advisory panel tasked with making recommendations regarding DEHP medical exposure to Health Canada also agreed that those at highest “theoretical” risk of reproductive health effects are newborns, but only upon receiving extraordinary care.³⁵ Still, this Canadian panel report is probably “the strongest call for action on DEHP yet,” as claimed by Rich Whate, HCWH’s Toronto spokesman.³⁶ That’s a curious boast, since the study hardly serves the organization’s purposes. The report offers no support for a ban or widespread restrictions on use. Explained the panel: “The risk of developmental and reproductive problems in the general adult population is small; but the risk to infants, toddlers, critically ill children and during pregnancy and lactation may be more significant. Thus our panel will make recommendations in the following report that relate to those likely to be at highest risk of this theoretical possibility.”³⁷

In discussing the theoretical risk, the Health Canada expert panel stated:

There are essentially no data to confirm toxicity of DEHP or its metabolites in humans; indeed, DEHP has been used in the plastic to produce blood bags for several decades without reports of disease or unexplained “abnormalities” in humans… Therefore, evaluation of risk to humans can only be extrapolated from animal data. Such extrapolations are questionable (without the incorporation of quantitative data on interspecies differences or human variability in toxicokinetics and toxicodynamics into the toxicity assessment) since there are significant species differences in metabolism that may completely alter the effect of a substance between experimental animal models and the human.³⁸

However, without clear, clinical evidence of a health impact, animal models are still the primary way to evaluate potential for harm. Laboratory research into the DEHP issue is ongoing, and the most recent science on DEHP medical exposure suggests that there would be no lasting reproductive health effects on humans. A study presented at the Society of Toxicology annual meeting in March 2003 revealed that the sex organs of male monkeys who were fed very high doses of DEHP from weaning to sexual maturity developed normally—i.e., they showed no evidence of testicular damage.³⁹ In addition, results of a study published in the May/June 2003 issue of the International Journal of Toxicology demonstrated complete or near complete recovery for rodents at sexual maturity after oral and intravenous exposure to DEHP.⁴⁰

Thus, while the body of science continues to grow, there is, as of yet, no definitive conclusion about the possible risks of DEHP exposure to potentially sensitive patients. The best policy, then, is to reduce unnecessary contact in these most vulnerable groups as a prophylactic, while not sacrificing the benefits provided by use of PVC products to the far larger universe of patients. Dr. Feigal suggests medical providers should consider looking for substitute materials or minimizing patient exposure. But he also warns: “Most importantly, you should not avoid the procedures cited [as yielding the greatest potential concern] simply because of the possibility of health risks associated with DEHP exposure. The risk of not doing a needed procedure is far greater than the risk associated with exposure to DEHP.”⁴¹ Indeed, while the European Commission expressed some concern over “groups of patients or individuals who experience prolonged periods of elevated DEHP exposure,” it went on to explain: “In view of the lack of a full analysis of all risks associated with potential alternative materials, at this moment no specific recommendations can be made to limit the use of DEHP in any particular group.”⁴²

Applying the Precautionary Principle

HCWH advocates application of the “precautionary principle.”⁴³ Extreme environmentalists have in-creasingly succeeded in embedding this sensible-sounding principle in national policy and international agreements.⁴⁴ In practice, however, activists define the principle as banning a product even without evidence of harm, since there is always the possibility of harm. As HCWH reluctantly admits in response to the industry’s claim that there is no evidence that anyone has ever been harmed by phthalates, “To some extent that is true.”⁴⁵ But, contends the organization, “Lack of evidence can hardly be used as evidence of safety.” Thus, “evidence from relevant animal studies and from limited studies of non-reproductive tract impacts in hospitalized patients is sufficient to require phasing out the use of many of the phthalates.”⁴⁶

Since those studies suggest only the theoretical risk to very limited populations, the organization is basically advocating a ban based on no evidence. In this way, writes science analyst Ron Bailey, “Proponents of the precautionary principle are trying to smuggle in a default position: The environment trumps all other values.”⁴⁷

From the perspective of the Judeo-Christian moral tradition, this can hardly be considered an acceptable position. For at its heart, this “environment above all else” position views man in opposition to nature, rather than in stewardship of creation, which is the traditional understanding. Further, the “environment above all else” position understands humans to be, intentionally or not, primarily consumers and polluters. The underlying premise of these assumptions is an ultimately anti-human, neo-Luddite line of thought that understands man to be a threat to the “natural environment.”

Where the risk of harm seems real and costs of “precaution” are minimal, sensible policy dictates that exposure be reduced. After all, that’s what regulatory policy theoretically does today: it weighs the potential benefits and costs of an action or product. It also reflects “the basic Christian virtue of prudence,” argues Andrew Brand, formerly of the Acton Institute.⁴⁸ In contrast, proponents of the precautionary principle usually advocate banning actions or products “even if the probability and magnitude of such harm has not been demonstrated scientifically,” warns Gregory Conko, director of food safety policy at the Competitive Enterprise Institute.⁴⁹

The supposed justification for such a policy is that the earth faces an extreme environmental crisis. Yet even as synthetic chemicals multiply, cancer rates are falling; according to the FDA, manmade substances account for fewer than 2 percent of cancers.⁵⁰ The most significant health risks in contracting cancer are behaviors, such as smoking. Even children, thought to be most at risk from chemicals, are far more endangered by preventable causes, ranging from accidents to fetal alcohol syndrome.⁵¹ Thus, argues Conko, the precautionary strategy “is being pursued, not to make the world safer, but rather to advance specific political and philosophical agendas.”⁵² Indeed, this interpretation of the principle “incorporates the values of the most extreme versions of know-nothing environmentalism,” argues Bailey.⁵³

In the same way that all actions and products entail risk, so does failure to act or use a product. What he calls a Type 2 error of failing to use a safe, new technology “can also be lethal,” warns Fred Smith, president of the Competitive Enterprise Institute.⁵⁴ Examples of the harm caused by being risk-averse are legion. Peru discontinued chlorination of water, resulting in a deadly cholera epidemic.⁵⁵ Banning, rather than restricting, use of the pesticide DDT, led to a deadly upsurge in malaria worldwide.⁵⁶ In the name of saving the environment, people suffered and died. This is one concrete realization of what happens when the “environment” is posited over and against human need. The results are not trivial, as least as far as lives are concerned.

Thus, while one must assess any theoretical risk of using PVC, one must apply the same analysis to any materials used in its place. The Lowell Center for Sustainable Production, in a study for HCWH, criticized PVC products not for being dangerous, but for not having proven themselves to be safe: “Inadequate evidence exists to conclude that the toxic mechanisms found in laboratory animals do not occur in humans”; thus, “considerable uncertainty about many aspects of the potential health hazards of DEHP remains.” As a result, the center contends that PVC substitutes should be considered because they “have the potential to be safer alternatives to DEHP-containing medical devices.”⁵⁷ This argument, however, is common sense turned on its head. Consideration of PVC alternatives is, in and of itself, fine. However, given that PVC has a proven safety record, is it prudent or wise to promote the replacement of less-tested alternatives to PVC?

Yet the report went on to warn about dangers posed by PVC substitute plastics, such as polyolefins—which “are most likely to compete with PVC in the long-run”—polyurethanes, polycarbonates, and ethylene vinyl acetate.⁵⁸ Even HCWH itself concedes that use of rubber latex gloves raises concerns for those who are allergic to latex.⁵⁹ Other problems caused by PVC alternatives include skin irritations and unpleasant odors. Thus, the Lowell Center seemed to turn the precautionary principle on its head when it concluded that “shifting away from DEHP can begin immediately without waiting for ‘final proof’ that an alternative is better. These alternatives may be safer than PVC throughout their lifecycle but careful, thorough analysis is needed as the basis of final material choice.”⁶⁰

Most important, several vinyl alternatives themselves have insufficient use experience and test results to pass muster under the precautionary principle as interpreted by PVC critics.⁶¹ It was no surprise, then, that the European Commission did not make any specific recommendations regarding substitutes.⁶² As Dr. Feigal of the FDA warned, “We would need to see substantial amounts of testing to make sure we weren’t moving from a product with good characteristics to one that we didn’t know much about.”⁶³ Creating more significant risks in the attempt to eliminate very small or theoretical risks is simply bad policy and even worse moral reasoning when people’s lives are at stake.

Even more importantly, the medical cost of not using vinyl must also be balanced against its obvious advantages. For some products, such as tubing for peristaltic pumps and peritoneal dialysis (peritoneal dialysis works on the same principle as hemodialysis, but the blood is cleaned inside the body rather than through a machine), there are no substitutes. Risks must be compared and balanced to make policy intelligently.⁶⁴ Writes Bill Durodie, a research fellow for the European Science and Environment Forum, “The goal should be to create systems to allow individuals to minimize risks when possible and take risks where necessary to reap certain benefits.”⁶⁵

An arbitrary, reflexive application of the “precautionary principle,” as suggested by HCWH, would sacrifice significant benefits and create new harms in order to eliminate a very small risk of harm. This haphazard application would abandon any assessment of costs and benefits. Observes Conko, “What I think most of us really want from public policy, however, is not for it to focus only on the risks generated by new technologies, but rather that it genuinely try to deliver a safer world.”⁶⁶ In the case of vinyl, that means using the product where the risks are theoretical and de minimus, while looking for cost-effective alternatives in the few cases where there is greater reason for concern and where treatment would not suffer from switching products.

Finally, there is no guarantee that HCWH and particular radical members like Greenpeace would accept the substitutes if PVC products were displaced. Warns Bill Durodie: “Once Greenpeace achieves its objective to eliminate vinyl plasticized with phthalates, health care providers should be ready for a new battle regarding the unsuitability of the substitutes.”⁶⁷ What aspect of modern life would survive a radical application of the precautionary principle?

Conclusion

New technologies have done much to improve the environment, health, living standard, safety, and well-being of humankind. So it has been with PVC. Of course, some inventions have ill effects, and even those products that have performed well over the years may eventually be found to create harm. We always must observe and investigate, no matter how satisfactory the safety record of a product or procedure.

In the case of vinyl, the technology’s benefits are obvious and significant. It helps medical professionals save lives and heal injuries. In addition to being inexpensive and cost-effective PVC is often the only option for certain products. Banning it—either explicitly through governmental regulation or implicitly through private pressure—should require a showing of likely and serious potential harm. Acting otherwise would violate the fundamental moral duty to care for the sick.

Yet five decades of use have left no trail of injured parties. Only a theoretical possibility of harm has arisen through animal experimentation—results made dubious by the significant differences between rodents and humans in this case. And even that theoretical possibility applies only to small, uniquely sensitive populations, primarily newborns.

Thus, precaution is in order, but rational precaution—one that reflects a balancing of costs and benefits. As Indur M. Goklany, author of The Precautionary Principle, puts it, in choosing between two paths, one must “ensure that in avoiding goblins we do not fall prey to wolves.”⁶⁸

Should health care providers have concern about DEHP exposure to potentially vulnerable patient groups, then they should consider reducing PVC use to those patients when medically possible—where there are substitute materials that have proven safety and efficacy records at least comparable to vinyl or where changing treatments will not harm the person being served. The goal is to put patients first, affirming the importance of human dignity and life over abstract ideology antagonistic to technology. Only in this way will we achieve the goal of “health care without harm.”

Endnotes

1. Health Care Without Harm “Mission Statement,” www.noharm.org, January 17, 2003.
2. John Paul II, Ecclesia in America, section 25.
3. C. Everett Koop, “The Latest Phony Chemical Scare,” Wall Street Journal, June 22, 1999.
4. American Council on Science and Health, “A Blue Ribbon Panel Report: A Scientific Evaluation of Health Effects of Two Plasticizers Used in Medical Devices and Toys,” June 22, 1999, 6. For a copy of the full report, see “A Scientific Evaluation of Health Effects of Two Plasticizers Used in Medical Devices and Toys: A Report from the American Council on Science and Health,” www.medscape.com, June 22, 1999.
5. Kenneth Green, “Phthalates and Human Health: Demystify-ing the Risks of Plastic-Softening Chemicals,” Reason Public Policy Institute, www.rppi.org, July 2000.
6. Health Care Without Harm, “Sample Letter to Group Purchasing Organizations,” part of Going Green: A Resource Kit for Pollution Prevention in Health Care, October 15, 2001.
7. Most recently, the group filed its views in a case before the Food and Drug Administration: “Re: Medical Devices Made with Polyvinylchloride (PVC) Using the Plasticizer Di(2-ethylheyxl) phthalate (DEHP); Draft Guidance for Industry and FDA,” letter from Charlotte Brody to To Whom It May Concern, Docket No. 02D-0325, www.noharm.org, December 4, 2002.
8. Interfaith Center for Corporate Responsibility, “Phase Out PVC Use in Manufacture of Medical Supplies,” www.iccr.org, December 26, 2001.
9. For a detailed look at Greenpeace’s attack on phthalates, including DEHP, see Bill Durodie, “Poisonous Propaganda: Global Echoes of an Anti-Vinyl Agenda,” Competitive Enterprise Institute, July 2000.
10. Health Care Without Harm, “Dioxin, PVC, and Health Care Institutions,” part of Going Green: A Resource Kit for Pollution Prevention in Health Care, October 15, 2001.
11. Health Care Without Harm, “Background on PVC,” www.noharm.org, January 17, 2003.
12. Durodie, 21.
13. American Chemistry Council’s Chlorine Chemistry Council, “Dioxin Facts—Sources and Trends,” based on the Environmental Protection Agency’s Inventory of Sources of Dioxin-Like Compounds in the United States, 1987 and 1995. Dioxin emissions levels for 2002–2004 are based on epa projections assuming full compliance with regulatory levels by this period and the closure of a copper smelter, www.dioxinfacts.org/sources_trends/sources.html.
14. Ibid.
15. Environmental Protection Agency, “Dioxin: Summary of the Dioxin Reassessment Science,” June 12, 2000.
16. American Chemistry Council’s Chlorine Chemistry Council, “Dioxin Facts—Sources and Trends.”
17. See, for example, European Commission, “Green Paper on Environmental Issues of PVC,” 2000, 49; Office of Research and Development, National Center for Environmental Assessment, “The Inventory of Sources of Dioxin in the United States,” external review draft, April 1998; C. R. Yennie, “Methods to Reduce HCI Emissions in a Medical Waste Incinerator Equipped with a Dry Scrubber,” paper presented at the Air and Waste Management Association Annual Meeting, 1997.
18. Environmental Protection Agency, “Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators,” U.S. Federal Register 62 (September 15, 1997).
19. H. Gregor Figo et al., The Relationship between Chlorine in Waste Streams and Dioxin Emissions from Waste Combustor Stacks (New York: American Society of Mechanical Engineers, 1995), iv, v.
20. Center for Devices and Radiological Health, “Safety Assessment of Di(2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices,” undated, 4.
21. See, for example, Durodie, 23.
22. David Feigal, “FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP,” July 12, 2002, 2.
23. “A Blue Ribbon Panel Report,” 6.
24. “Priority Substances List Assessment Report: Bis (2-ethylhexyl) phthalate,” Health Canada 26 (February 19, 1999); R. C. Cattley et al., “Do Peroxisome Proliferating Compounds Pose a Hepatocarcinogenic Hazard to Humans?” Journal of Regulatory Toxicology and Pharmacology 27 (1998): 47–60.
25. “Commission Decision of July 25, 1990, on the classification and labeling of di(2-ethylhexyl) phthalate in accordance with Article 23 of Council Directive 67/548/EEC,” Official Journal of the European Communities 222/49 (August 17, 1990).
26. Scientific Committee on Medicinal Products and Medical Devices, “Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity,” European Commission, Health and Consumer Protection Directorate-General, September 26, 2002, 25.
27. W. W. Huber, B. Grasl-Kraupp, and R. Schulte-Hermann, “Hepatocarcinogenic Potential of Di(2-ethylhexyl) phthalate in Rodents and Its Impact on Human Risk,” Critical Reviews in Toxicology 26.4 (1996): 365–481.
28. International Agency for Research on Cancer, “Some Industrial Chemicals,” Monographs on the Evaluation of Carcinogenic Risks to Humans 77 (February 15–22, 2000).
29. Angela Logomasino, “Chemical Risk,” in David Riggs and Angela Logomasino, eds., The Environmental Source 2002 (Washington, D.C.: Competitive Enterprise Institute, 2002), 28. See also Durodie, 12–13; and The Role of Toxicity Default Assumptions in Risk Assessment (American Industrial Health Council, 1997).
30. Center for the Evaluation of Risks to Human Reproduction, “NTP-CERHR Expert Panel Report on Di(2-ethylhexyl) phthalate,” National Toxicology Program, Department of Health and Human Services, October 2000, 102. See also Y. Tomonari et al., “Testicular Toxicity Study of Di(2-ethylhexyl) phthalate (DEHP) in Juvenile Common Marmoset,” paper presented at the Society of Toxicology Annual Meeting, Salt Lake City, March 2003. In general, rodents and primates break down and eliminate DEHP differently. The result is “peroxisome proliferation,” leading to liver cancer, in rodents but not humans. See, for example, N. J. Woodyatt et al., “The Peroxisome Proliferator (PP) Response Element Upstream of the Human Acyl CoA Oxidase Gene Is Inactive Among a Sample Human Population: Significance for Species,” Carcinogenesis 20.3 (1999): 369–372; Wolfgang W. Huber et al., “Hepatocarcinogenic Potential of Di(2-ethylhexyl)Phthalate in Rodents and Its Implication on Human Risk,” Critical Reviews in Toxicology 26.4 (1996): 365–481; International Agency for Research on Cancer, “Peroxisome Proliferation and Its Role in Carcinogenesis,” IARC Technical Report 24 (December 7–11, 1994); Agency for Toxic Substances and Disease Registry, Toxicity Profile for Di(2-ethylhexl)phthalate (DEHP) (Washington, D.C.: Department of Health and Human Services, 1993), 4–5; Letter from Victor Kimm, deputy director, Office of Prevention, Pesticides, and Toxic Substances, and William Farland, director, Office of Health and Environmental Assessment to Kenneth Olden, director, National Toxicology Program, June 9, 1992.
    
    Almost as significant as the foregoing scientific research was last fall’s result in Baxter v. Denton, in which a California court rejected the claim that DEHP caused cancer, based on the differences between humans and rodents. For the first time since the 1986 passage of Proposition 65, which mandates disclosure of potential human carcinogens, a manufacturer, Baxter Healthcare Corp., won an exemption for its products, which include catheters, dialysis equipment, and intravenous fluid bags. State officials claimed that few other industries would be able to seek such a ruling “because few have been subject to the research DEHP has undergone,” quoted in June D. Bell, “Cancer Warning Peeled Off,” National Law Journal, November 18, 2002. See also “Baxter Wins Exemption From Labeling Rule for DEHP Under California’s Prop 65,” Medical Devices Litigation Reporter 9.20 (2002).
31. Center for Devices an Radiological Health, “Safety Assessment of Di(2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices,” Food and Drug Administration, undated, 5–6. See also Center for Devices and Radiological Health, “Medical Devices Made with Polyvinylchloride (PVC) Using the Plasticizer Di(2-ethylhexyl) phthalate (DEHP); Draft Guidance for Industry and FDA,” Food and Drug Administration, undated, 2.
32. Center for Devices and Radiological Health, “Safety Assessment of Di(2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices,” Food and Drug Administration, undated, 3.
33. Center for the Evaluation of Risks to Human Reproduction, “NTP-cerhr Expert Panel Report on Di(2-ethylhexyl) phthalate,” Department of Health and Human Services, October 2000, 101.
34. FDA 2001 Assessment.
35. Health Canada, “Health Canada Expert Advisory Panel on DEHP in Medical Devices: Final Report 2002 January 11,” January 2002, 5.
36. Quoted in “Panel Recommends Partial Ban on Medical Plasticizer,” Canadian Medical Association Journal, January 29, 2002. Charolotte Brody, executive director of Health Care Without Harm, made almost exactly the same claim in a press release on which Rich Whate was listed as a contact. The report was “the strongest call for action on PVC medical devices softened with DEHP,” quoted in “Health Canada Panel Warns That Plasticizer in PVC Medical Devices May Harm Developing Babies, Infants, Boys,” Press Release, Health Care Without Harm, January 24, 2002. In fact, the succession of studies vindicating the use of vinyl in most cases seems to have caused HCWH to retreat; its materials now focus on the risk to children. See, for example, Ted Schettler, “DEHP Exposures During the Medical Care of Infants,” part of Going Green: A Resource Kit for Pollution Prevention in Health Care, October 15, 2001.
37. Health Canada Expert Advisory Panel on DEHP in Medical Devices. Appearing to follow in Health Canada’s tracks is the FDA, which has circulated a draft guidance document recommending greater care for “devices used in Neonatal Intensive Care Units.” “Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer Di(2-ethylhexyl) phthalate (DEHP); Draft Guidance for Industry and FDA,” Food and Drug Administration, undated, 2.
38. Health Canada Expert Advisory Panel on DEHP in Medical Devices.
39. “Testicular Toxicity Study of Di(2-ethylhexyl) phthalate (DEHP) in Juvenile Common Marmoset.” Toxicological Sciences 72: 385. Abstract presented by Y. Tomonari, Y. Kurata, and R. M. David at the 2003 Society of Toxicology Annual Meeting, Salt Lake City, March 2003.
40. J. N. Cammack et al., “Evaluation of Reproductive Development Following Intravenous and Oral Exposure to DEHP in Male Neonatal Rats,” International Journal of Toxicology 22.3 (2003):159–174.
41. Feigal, 3.
42. Scientific Committee on Medicinal Products and Medical Devices, 25–26.
43. See, for example, “Panel Recommends Partial Ban on Medical Plasticizer.”
44. See, for example, Indur M. Goklany, The Precautionary Principle: A Critical Appraisal of Environmental Risk Assessment (Washington, D.C.: Cato Institute, 2001).
45. Health Care Without Harm, “Aggregate Exposures to Phthalates in Humans” (draft), 2002, 48.
46. Ibid., 5.
47. Ron Bailey, “Precautionary Tale,” Reason, April 1999, 39.
48. Andrew Brand, “Health Care Without Harm?” (Grand Rapids, Mich.: Acton Institute, 2002).
49. Gregory Conko, “The Precautionary Principle: Protectionism and Environmental Extremism by Other Means,” presentation to the International Society of Regulatory Toxicology and Pharmacology Workshop, June 20, 2002.
50. Bailey, 40. See also Lois Swirsky Gold et al., “Misconceptions about the Causes of Cancer” (Vancouver, Canada: Fraser Institute, 2003).
51. See, for example, Stephen Huebner and Kenneth Chilton, “Overplaying Environmental Threats to Children,” Consumers’ Research, April 1999, 18–21.
52. Conko.
53. Bailey, 39.
54. Fred L. Smith, Jr., “Caution: Precuationary Principle Ahead,” Regulation, Summer 1997.
55. Gregory Conko and Henry I. Miller, “Precaution (of a Sort) Without Principle,” Priorities for Health 13.3 (November 1, 2001).
56. Conko.
57. Joel Tickner et al., “The Use of Di(2-ethylhexyl) phthalate in PVC Medical Devices: Exposure, Toxicity, and Alternatives” (Lowell, Mass.: The Lowell Center for Sustainable Production at the University of Massachussetts, 1999), 6.
58. Ibid., 43.
59. See, for example, Health Care Without Harm, “Latex Allergy in Health Care Fact Sheet,” part of Going Green: A Resource Kit for Pollution Prevention in Health Care, October 15, 2001.
60. Tickner et al., 50.
61. Durodie, 25–26.
62. Scientific Committee on Medicinal Products and Medical Devices, 26.
63. Quoted in David Brown, “Campaign Seeks to Eliminate Plastic IV Bags,” Washington Post, February 22, 1999.
64. See, for example, John K. Sutherland, “Science and Risk,” Fraser Forum, April 1997, 5–11; John C. Shanahan and Adam D. Thierer, “How to Talk about Risk: How Well-Intentioned Regulations Can Kill,” Heritage Foundation, April 23, 1996.
65. Durodie, 24.
66. Conko.
67. Durodie, 27. An even more cynical analysis suggests that victory over PVC would necessitate developing another target simply for fundraising purposes. Steven Milloy, publisher of Junkscience.com, observes that the anti-PVC campaign is part of the organization’s larger attack on chlorine, which also happens to be a major fundraising vehicle. Steven J. Milloy, “Media Lose Message,” Chicago Sun-Times, March 27, 2000. If that falters, Greenpeace would need to find another cause to take its place.
68. Goklany, 7.