Originally Published July/August 2000

EDITOR'S PAGE

We Interrupt this Editorial to Bring You a Message from the Vinyl Institute

In the April issue of MPMN, we reported on announcements made by Tenet Healthcare and Baxter that they would seek alternative materials to PVC for use in their medical products. My editorial in that issue also commented on the PVC controversy. While our coverage summarized a range of opinions, the amount of space available prevented us from presenting the viewpoint of the plastics industry in detail. The Vinyl Institute has asked for an opportunity to respond to assertions made by Greenpeace and Health Care Without Harm, which were echoed in MPMN. Printed below are excerpts from a letter that Allen Blakey, the institute's director of public affairs, sent me. The letter in its entirety can be viewed below.

Your editorial contends that Greenpeace and its surrogate, Health Care Without Harm (HCWH), have "successfully alerted the public" to the alleged risks of vinyl medical products. However, it appears that the public is largely unaware of these allegations or is, at least, highly skeptical of them. If consumers were truly alarmed by these false and misleading allegations, by now we would have seen a flux of patients refusing treatment with products made of PVC, as well as a likely decline in the number of blood donors. Based on our monitoring efforts, this issue has not even surfaced as a concern of any major blood bank or patient group whose constituents depend upon these critical-care products. Also, based on our contacts within the industry, we understand that the vast majority of healthcare providers have little, if any, knowledge of this issue.

The allegation, made by groups like Greenpeace, that the incineration of vinyl medical products is a major source of dioxin does not hold based on the following facts:

The newest regulations from the U.S. EPA will further reduce the already extremely low dioxin emissions from medical waste incinerators by 95%, basically rendering the argument moot.

The really good--but rarely reported--news is that EPA estimates that the total dioxin emissions in the United States dropped 75% between 1987 and 1995. And one fact that Greenpeace will never disclose is that during the same timeframe, the amount of vinyl produced tripled.

An overwhelming body of validated scientific evidence shows that DEHP is not a human carcinogen. In fact, as recently as February of this year, the World Health Organization's International Agency for Research on Cancer (IARC) handed down a significant decision to downgrade DEHP to "not classifiable as a human carcinogen."

The article "PVC Defections Continue" argues that there is a continuing trend toward the deselection of vinyl as the material of choice. However, in the past year HCWH's attempts to use shareholder resolutions to try to pressure manufacturers, product purchasers, and healthcare providers to adopt vinyl phase-out policies has reaped little in the way of results.You can count on one hand the number of organizations that have actually taken any action. Some companies' positions, like Baxter, have been and continue to be completely misrepresented by Greenpeace and HCWH. In fact, not only does Baxter continue to use vinyl, the company issued a PVC position statement affirming that " . . . PVC is the material of choice in many products."

While sensational claims, strong-arm tactics and cherry-picked science make great headlines and promote radical agendas, their shelf life is limited. When it comes to decision-making about vinyl medical products, we believe that performance, cost, a 40-year track record of safety and effectiveness, and most importantly scientific support for safe usage are the true litmus test for choice.

Norbert Sparrow
[email protected]

June 1, 2000

Mr. Norbert Sparrow
Medical Product Manufacturing News
11444 W. Olympic Blvd., Suite 900
Los Angeles, CA 90064-1549

Dear Mr. Sparrow:

I am writing to follow up on the editorial and article concerning the debate over PVC medical products that appeared in the April issue of MPMN. Based on our ongoing work and monitoring of this issue, we do not believe the activists' anti-vinyl agenda is progressing as your magazine appears to suggest. To the contrary, recent events in the scientific community and medical device industry indicate that the facts are trumping the activists' allegations, and that activists are losing traction in this debate. Outlined below are a few points for your consideration:

Heightened public awareness. Your editorial "There is (Still) a Great Future in Plastics, but Maybe Not in PVC" contends that Greenpeace and its surrogate Health Care Without Harm (HCWH) have "successfully alerted the public" to the alleged risks of vinyl medical products. However, it appears that the public is largely unaware of these allegations or is at least highly skeptical of them. Also, based on our contacts within the industry, we understand that the vast majority of healthcare providers have little, if any, knowledge of or concern about this issue. Medical practitioners depend on governmental bodies, such as the U.S. Food and Drug Administration, for the approval and regulation of medical devices, and vinyl continues to be the material of choice used in many products that meet FDA's review and stringent approval requirements. Finally, media coverage of this issue has been limited primarily to trades and policy publications and has, for the most part, been balanced. In fact, I would say there is a growing skepticism among the media regarding the "win at any cost" strategies being used by Greenpeace and HCWH to advance their position.

PVC medical products do not pose an environmental risk. The allegation, made by groups like Greenpeace, that the incineration of vinyl medical products is a major source of dioxin does not hold based on the following facts: (1) Vinyl medical products comprise a minute portion of solid waste in the United States - only 0.03 percent. (2) Further, numerous studies have indicated there is no statistically significant correlation between the amount of PVC burned in a medical waste incinerator and the amount of dioxin that might be emitted from that combustion. (3) The newest regulations from the U.S. EPA will further reduce the already extremely low dioxin emissions from medical waste incinerators by 95 percent, basically rendering the argument moot. The really good - but rarely reported - news is that EPA estimates that the total dioxin emissions in the U.S. dropped 75 percent between 1987 and 1995. And one fact that Greenpeace will never disclose is that during the same time frame, the amount of vinyl produced tripled.

DEHP is not a human carcinogen. An overwhelming body of validated scientific evidence shows this to be true. In fact, as recently as February of this year, the World Health Organization's International Agency for Research on Cancer (IARC) handed down a significant decision to downgrade DEHP to "not classifiable as a human carcinogen." Previously IARC had classified DEHP as a "possible human carcinogen." Based on scientific research about DEHP generated in the past two decades, this decision, from a prestigious international body, has dealt the anti-vinyl campaign a major blow. We look forward to the upcoming findings of both the FDA and NTP reviews regarding DEHP and hope they will confirm, once and for all, the safe use of vinyl medical products.

Vinyl is still a material of choice. The article "PVC Defections Continue" argues that there is a continuing trend towards the deselection of vinyl as the material of choice. However, in the past year, HCWH's attempts to use shareholder resolutions to try to pressure manufacturers, product purchasers and healthcare providers to adopt vinyl phase-out policies has reaped little in the way of results. Out of hundreds of manufacturers, thousands of hospitals, and dozens of group purchasing organizations, you can count on one hand the number of organizations that have actually taken any action. Some companies' positions, like Baxter, have been and continue to be completely misrepresented by Greenpeace and Health Care Without Harm. In fact, not only does Baxter continue to use vinyl, the company issued a PVC position statement affirming that "...PVC is the material of choice in many products." Other companies, not mentioned in your coverage, including Abbott, Columbia/HCA and most recently Tyco (in April 2000) have all strongly rejected these anti-vinyl shareholder resolutions. And for good reason. First and foremost, existing science does not support the activists' allegations. Additionally, finding suitable alternatives to vinyl for medical products is not an easy task, because vinyl possesses many qualities including flexibility, strength, sterilizability, clarity, compatibility with many drug products, and cost-effectiveness. We understand most, if not all, alternatives to vinyl for use in medical products today are multi-material or laminate, which makes them more difficult to process, handle, recycle and dispose.

While sensational claims, strong-arm tactics and cherry-picked science make great headlines and promote radical agendas, their shelf-life is limited. We believe when it comes to decision-making about vinyl medical products, performance, cost, a 40-year track record of safety and effectiveness, and most importantly - scientific support for safe usage, are the true litmus test for choice. The health care system demands quality and the manufacturing community will not be intimidated into switching to materials that may not perform as well, cost more and have unproven track records. In short, vinyl is delivering now - and will continue to do so into the future. Thank you for the opportunity to respond.

Sincerely,

Allen Blakey
Director, Public Affairs

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