It feels strange to be sitting in my office, just a few miles from the Pentagon and three blocks from the White House, writing this column about phthalates and PVC medical products. It seems trivial, as thoughts and prayers gravitate toward concern about the tragedy and what the future will bring for people everywhere. But it's also important to return to some sense of normalcy, I tell myself.
That said, the Food and Drug Administration's report earlier this month about phthalates' safety in PVC medical products got me thinking about the future of health issues surrounding plastics.
Clearly, the report said most people have nothing to worry about. The FDA said adults receiving intravenous solutions or peritoneal dialysis don't get enough di(2-ethylhexyl) phthalate to raise concerns.
But the report also legitimized concerns raised by Health Care Without Harm and other groups. It noted critically ill infants can get 20 times the safe levels of DEHP and raised concerns with infants undergoing some blood transfusions, adults receiving extracorporeal membrane oxygenation or some cardiopulmonary bypass procedures, and people receiving enteral nutrition solutions.
Industry officials have wondered if the effort into the FDA review and a similar review by the National Toxicology Program was worth it. But you could say we wouldn't be aware of problems for some people without groups raising questions.
What got me thinking about what this means for plastics and health issues is the reaction this issue received at a medical plastics conference I attended in Chicago last year. A Vinyl Institute representative gave a paper with the authoritative-sounding title “Vinyl Medical Products: The Facts.” It labeled HCWH and others as “surrogates and front groups” for Greenpeace. The implicit message to the plastics crowd: These concerns are not legitimate, and anybody who raises them is a patsy for an anti-vinyl and anti-chlorine agenda.
There was also a debate at the conference about how the topic was presented. The conference came several months after NTP's report, which had reached conclusions very similar to FDA's. No one formally presented NTP's conclusions, but the group did hear a formal presentation from a panel chaired by former Surgeon General C. Everett Koop, which said there was absolutely no cause for concern.
Organizers said the conference agenda was already set when the NTP released its report. That's fair. But one organizer added candidly that “we haven't found anybody with a valid counterpoint.”
The industry is going to face more questions in coming years about health issues in its products. A wealth of data from new government-testing programs is going to become available. The public's going to demand more from industry than dismissive attitudes and rhetoric raising a Greenpeace bogeyman. There are legitimate scientific disagreements here. The AdvaMed device makers trade group, for example, has been critical of the FDA study for, in its opinion, not giving enough weight to one of its studies.
Industry always says it wants decisions based on sound science. It should be prepared to accept that in some cases sound science may find problems.
Toloken is Plastics News' Washington-based reporter.