Good morning. My name is Jon Cammack. I want to thank you for the opportunity to speak this morning.
Like Stephen, I don't have any formal presentation. I didn't send anything to the committee, but I am going to be speaking from notes.
As just some background on myself, I have a PhD in pharmacology and toxicology. I'm a board-certified toxicologist. I've been with Baxter Healthcare for almost 12 years now. For the last eight-plus years I have chaired AdvaMed, which is the sister trade organization to MEDEC in the United States.
I've chaired AdvaMed's toxicology PVC working group. That working group has been very proactive in partnering, especially with regulatory agencies, on the safety of DEHP and PVC. We worked with Health Canada. We worked with the USFDA and the U.S. national toxicology program on a fairly large industry study that looked specifically at the reproductive and developmental effects of DEHP in developing rodents.
One of the things that Steve stressed is very true. The industry has been very proactive on this issue. We have addressed it head-on.
I am going to spend a few minutes just talking about the science on this topic. I would say if there is any take-away message I would want to leave with you, it's that there is no scientific data that exist right now that indicate that DEHP PVC is harming humans in medical applications--none. There is no science that supports that.
There is a lot of science on the effects of DEHP in animals, and especially in rodents, but for many reasons, that's not applicable to DEHP PVC, as it's used in medical therapy. Again, of anything I would like to leave the committee with, that's what it would be.
I do want to start and just say that in terms of medical products, there are very stringent regulatory requirements that define what kinds of safety studies and what kinds of efficacy studies need to be performed on drugs, devices, and biologics. There are very extensive safety toxicology studies.
There is a certain set of guidelines called ISO 10993 for medical devices. There are ICH, International Conference on Harmonisation, guidelines for drugs. There are special guidance documents for other types of medical products.
This is a very heavily regulated industry and we have to meet very high standards in terms of safety. And all the products that are currently on the market in Canada and countries around the world have gone through these testing criteria. Again, there are very specific toxicology and safety testing requirements.
In terms of DEHP and PVC medical products, I would say, honestly, there is an unmatched product history there. There are over 45 years of clinical use and literally one billion to two billion days of chronic exposure in patients using these products. And as I said earlier, there is no scientific evidence that these products are in any way harming patients at all. It's just the opposite: they're necessary and lifesaving therapies.
I would like to draw your attention to a very recent review that the U.S. national toxicology program conducted. They have a special branch of the national toxicology program that focuses on risks to human reproduction. They have spent the last seven to eight years, again, studying the effects of phthalates, and specifically, DEHP.
There was a lot of information and data that the expert panel reviewed. The overall conclusion was that there was no human data that indicated DEHP exposure from medical products during pregnancy, childhood, or adulthood was causing harm.
Several years ago, the United States FDA did a safety assessment on DEHP PVC medical products. The end result was the derivation of a safety threshold for exposure to DEHP. The overall conclusion from that assessment was that there was little to no risk to human safety with the vast majority of medical PVC use.
Some very specific therapies--such as ECMO therapy, which is used when premature babies are having their blood oxygenated--are listed by the FDA as risk categories, but they did not say that those therapies and products used in them were unsafe.
About two years ago there was a follow-up study on young adults who had been exposed to DEHP during ECMO therapy as premature infants. The intent of that study was to look for any potential adverse effects on the reproductive system. In all those patients who were looked at in this follow-up study, there was no evidence of effects on the reproductive system, reproductive organs, or sexual hormones. That was a very pivotal study.
There has been a lot of focus within regulatory agencies around the world on this topic. I mentioned the FDA assessment. In February 2002, Health Canada published their final safety assessment on DEHP PVC medical products. Their overall conclusion was very similar to the assessments of the USFDA, the U.S. national toxicology program, and the special committee that looks at reproductive effects in humans.
Like the FDA, they also identified special risk categories like ECMO therapy used for premature infants. The FDA safety assessment and the Health Canada safety assessment were finalized before this ECMO follow-up study. That again was a key science-based study that looked at this very unique patient population.
There are other countries, and states within the U.S., that have looked at DEHP and PVC. California is one state that is very environmentally conscious. It has focused on this issue for many years. Approximately three years ago there was a California Assembly bill, Bill 1139, the Lowenthal bill, that called for a ban of DEHP PVC medical products. That bill was absolutely voted down.
The International Agency for Research on Cancer, which is part of the World Health Organization, downgraded the status of DEHP as a chemical that could potentially cause cancer in humans, because of the science. It showed that the way DEHP caused effects in rodents was not able to happen in humans because of the genetic machinery of primates and humans. There were other reasons why they downgraded DEHP, but again they were very science-based.
In Europe, many national European ministries of health have followed that, like the International Agency for Research on Cancer. The Swedish National Board of Health and Welfare is a notable example. It's another very environmentally conscious agency that has downgraded DEHP as a possible human carcinogen, because of the science.
That's a very brief background on the science. There is a tremendous volume of data here.
All that having been said, vinyl DEHP is safe and effective for many medical applications; however, it's not functionally the right material for every medical product application. The industry, including Baxter, has been very proactive for many years in introducing alternative materials. It hasn't been reactive; it has been proactive in the sense of finding the right materials for very unique and specific applications.
The claim made that non-PVC products are safer than PVC products is just not correct. All medical product materials are held to the same regulatory standards. Health Canada doesn't look at a PVC medical product any differently than it does a non-PVC product. It's the same for agencies world-wide. The same standards are applied.
Scientifically it's unclear why there is still a focus here, in light of all the national and international reviews, and especially in the sense that alternative materials are constantly evolving in the industry. Where there are unique functional requirements, those products have been introduced. It's a matter of looking at the right material for whatever the unique clinical application is.
In conclusion, medical products are held to safe and effective standards. Medical applications of PVC and vinyl are recognized by international and national regulatory agencies around the world. The cumulative body of science absolutely supports the safety of DEHP and PVC medical products, and I would submit that public health is not served by uninformed or reactionary policy decisions.