A paper just published in Tox Sci shows that PFOS (the chemical that used to be the prime ingredient in Scotchgard) suppresses the immune system at levels, that didn't cause noticeable toxicity that are same as what are found in the general population. Great. So, basically, many people in the US who show no other signs may have compromised immune systems because of PFOS. And what's worse is that other compounds like PFOA, related to Teflon treatments (read more here), also have the same effects in other mouse studies.
You know this is really a toxicologist's nightmare. I'd like to think that because of this really well-done and important study, something will happen on the PFC front. Really though, I'm not too hopeful. For decades people sit on data that PFCs are harmful and don't follow up on it. Gee, good thing we did the studies. Also, our environmental laws are so weak, companies can simply not submit them to the gov't and eat the fine (if it ever comes). Then when some of the problems of PFCs (don't break down, found in everyone, immune and development problems) become public, 3M got out of the business but DuPont ramped up production to fill the void. They continue to fight doing anything serious about it and despite this new study and volumes of research showing the harms and the sources, they will continue to make these chemicals and commit chemical trespass.
Sometimes, it's just not worth it to get up in the morning as a toxicologist. Studies that find harm are dismissed for one reason or another by industry and the gov't is too weak to do anything about it. So what really is the point of conducting a study if a positive finding is going to be ignored?
PS And don't anyone comment that it's mice not people; it would be almost impossible to do an epi-study in the US population on this problem ($ and logistics). 1) we're all exposed so there is no real control so you'd have to look at a dose response. 2) Everyone is exposed to a mixture of PFC chemicals as well as other chemicals that may be immunosupressants; confounding the study. The combination of those two would make the study, well, near impossible.
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You're concentrating on too small a part of the overall picture. Environmental laws in the US are not "weak", in fact they're extremely strong for a comparatively immature regulatory system that's only existed for a single human generation. The problem is that they're a blunt cudgel that does not (and maybe cannot) be as nimble as the industries they oversee without stifling development.
Still, they don't really need to go that far. There are multiple, tiered safety nets; and arguably, with the PFOS situation all we see so far is a partial failure. If companies make bad decisions, they get sued for harming people or the environment.
The problem, of course, is that part of the system focuses on post hoc relief, which means that people are already harmed before the mechanisms kick into play. But even so, I'd argue that it's an essential part of the system, and only way of guaranteeing that the public's well-being gets translated into corporations' self-interest. Corporations today know the consequences can be dire if they ignore public health concerns. Think Johns-Manville, for isntance. Also see 3M's FY 2007 annual report, which gives a bit of background on the ongoing litigation over its historic PFOS releases:
http://ccbn.10kwizard.com/xml/download.php?repo=tenk&ipage=5474120&form…
If companies make bad decisions, they get sued for harming people or the environment.
This probably deters some companies for doing bad things, but it seems like an awful lot of them decide that they'll go ahead with the dangerous products and risk the lawsuits. They probably figure that a) maybe the injured parties would find it too difficult to prove causation, and will either not sue or will lose, or b) their profits will be larger than their legal bills and/or damages.
How else to explain Vioxx? Merck knew it had problems, but released it anyway. The eventual deluge of lawsuits was predictable.
Of course, a Texas judge dismissed 1,000 Vioxx cases under a new provision in an FDA rule that says FDA drug-label approval pre-empts liability lawsuits. And the Supreme Court just decided that FDA approval of medical devices pre-empts liability lawsuits. Potential lawsuits are even less of a deterrent than they used to be.
Well, I don't think that anybody would argue that post-injury lawsuits should be the primary means to safeguard consumers. My point is that companies need to (and do) take these sorts of otherwise-avoidable costs into consideration. Massive product liability losses harm companies' goodwill, get decisionmakers fired or demoted, act as bait for shareholder suits, and jack up insurance costs.
IMHO, this threat of lawsuits - serving only as a backstop to front-line government regulations - works extremely well in most industries you can think of, from giant refineries to small lawn care companies, because the costs imposed by lawsuits usually scale with the nature of the wrongdoing. There are exceptions, of course.
The bluntness of the tool is a problem in itself.
Liz wrote: "How else to explain Vioxx? Merck knew it had problems, but released it anyway."
One explanation is that Merck (and the regulators) judged that the good that Vioxx could do outweighed the problems, which was in fact probably the right judgement. And then the massive liability suits forced it off the market, a fact that many patients still lament. There are a great many people out there whose lives were greatly enhanced by that drug, and who would gladly still be taking it, fully knowing the risks, if they were allowed to.
A better answer to a lot of these things is to require that the information be available, but then to let people make their own decisions (and limit the liability of the company if they have provided such information).
Also, there should be limits if the company did not know, and could not reasonably have known, about damages, but then did respond quickly when the problem became known. If, as in this case, there was no way to know that the low levels of PFCs cause the immune system problems, then a company can't really be held at fault for not acting on information that was not available. If then, as with 3M, the company responds responsibly, that's about all that can be expected. Reasonable strict liability for actual demonstrable damage could then still be appropriate, but large suits and any punitive measures will cause more harm than good.
If we can manage to work toward a system where the liability is limited for companies that practice good disclosures and respond responsibly to new information, and thus are only severely punished for actual fraud or for knowingly endangering others, then this would go a long way toward discouraging the hiding of information. The current system is too much of a crapshoot; a company is almost as likely to get sued to death for being open and responsible as not, and so it's no surprise that things get buried.
PhilB
Jim,
I'd have to disagree with you about the strength of our laws. EPA tried to ban asbestos and was shut down by the courts saying that the bar the law had set was not cleared. If you can't ban asbestos, you really can't ban anything. Look at the other chemicals that have been banned (by work of Congress), and this will be further confirmed.
Also, look at the DuPont/3M/EPA process. The whole issue of PFCs and what should be done with them was never in the hands of the Agency. Knowing the weak position they were in, the Agency tried to draft an Enforceable Consent Agreement, which sounds strong, but since the industries get to choose on what they are agreeing to, it's rather weak. But even that was too much for the industry and after a couple of years of haggling, it was converted into a Memorandum of Understanding. So not only did they get to set the terms of the agreement, they specifically noted that they really didn't have to keep to the terms. That's amazingly week.
Phil,
One of the few tools the EPA has is manditory reporting of the studies. The studies that showed harm were kept secret for about 15 years. When the EPA found out about it, they finally got around to levying the largest fine in their history (~$16 M, that's sad in and of itself). It is estimated that DuPont made about $300M a year off of the PFOA technology for it's Teflon products. Not submitting studies that show harm can simply be written into the cost of doing business.
I'm not sure about whether the open information is enough. In this situation, even when the data was made public, 3M got out but DuPont ramped up production. So, they're still making the stuff for stain-resistant pants, and water resistant coatings. For a consumer today, this information being released hasn't made all that much difference. For it to work, you'd need a media that had the time and space to report everything, a public that had the capacity to understand the scientific principles and a government with enough money to counter the industry PR. I think the government would actually be larger if it's duty was to try and education consumers so as to make responsible choices.
Just saw presentations by Chris Lau and others give a bunch of presentations on these a few weeks ago. His was on the developmental tox angle. Neonatal mortality, developmental delays, lower levels of thyroid hormone. And half-lives in most of the animal models that are virtually orders of magnitude shorter than in humans. Not only do we like to use the stuff, our physiology loves it so much it can hold onto it for years. And these compounds essentially redefine what we mean by "persistent". Fun stuff.
btw... If you could throw me any tricky questions you have on this topic that I could use to stump Dr. Wallace this afternoon, I promise I'll give you credit sometime shortly after the fact.
Re: angrytoxicologist's comment. Clearly this is a subject to which you've given some thought, but I cannot agree with most of your conclusions. Sorry in advance for the length of my post:
(1) Bear in mind that for all practical purposes the US did not have ANY environmental laws prior to 1970, at least not in the modern context. The Clean Air Act, Clean Water Act, National Environmental Policy Act, CERCLA/SARA, RCRA/SWDA - all are later creations, or are wildly different versions of prior laws with which they share little but a name. The EPA itself was only created in 1970. Most state analogues of the EPA were created even later.
Product liability litigation was a minor sideshow in the 1940s and 1950, mostly limited to suits against manufacturers of foodstuffs and pharma products. A variety of legal doctrines (e.g., lack of privity between the manufacturer and the end user) kept litigation to such a minimum that insurance companies had trouble selling companies policies that protected them against this kind of liability. It was not until the early 1960s that the doctrine began to expand, and not until 1973 (the Borel case) that it was extended to include asbestos.
This explains why the asbestos phase-out/ban began in 1970-73, why governmental agencies weren't concerned with PFCs in the 1950s/60s, and so on. When you consider that the history of modern environmental/product liability litigation basically "began" in the mid to late 1970s, I think progress has been pretty swift.
(2) Companies don't just "get to choose on what they are agreeing to" in a consent judgment or a MOU. They're entered in settlement of an enforcement action, and their scope is usually in direct proportion to the strength of the government's action (i.e. the evidence, the law, the damages done, remediation cost) and the government's resources and interest in litigating the matter to conclusion. Typically, the government agency will draft the proposal and push for maximum relief, the company will negotiate for lesser burdens, and depending on the law and the evidence the government will take the best it can get.
Of course, political considerations can affect how zealously the agencies pursue certain matters (or how much money they have to pursue them), but that's not an indictment of the law per se. I.e., if you don't like they way 7 years of the Bush administration has deemphasized certain types of environmental activities, vote for someone else this November.
(3) Your focus on EPA fines is understandable but mistaken. Companies are less afraid of "fines" than they are of enforcement actions that compel them to remediate past releases (which can cost tens or hundreds of millions of dollars), of losing operating permits (which can close entire plants), of failing to win new operating permits (leaving new plants under capacity and/or slowing expansion), of finding themselves on one of the major plaintiffs' firm's "target lists" that renders them subject to tens of thousands of product liability lawsuits per year, and of grueling litigation with government agencies that can stall other projects and drain resources and focus for years.
angrytoxicologist weote: "Phil,
One of the few tools the EPA has is manditory reporting of the studies. The studies that showed harm were kept secret for about 15 years. When the EPA found out about it, they finally got around to levying the largest fine in their history (~$16 M, that's sad in and of itself). It is estimated that DuPont made about $300M a year off of the PFOA technology for it's Teflon products. Not submitting studies that show harm can simply be written into the cost of doing business.
I'm not sure about whether the open information is enough. In this situation, even when the data was made public, 3M got out but DuPont ramped up production. So, they're still making the stuff for stain-resistant pants, and water resistant coatings. For a consumer today, this information being released hasn't made all that much difference. For it to work, you'd need a media that had the time and space to report everything, a public that had the capacity to understand the scientific principles and a government with enough money to counter the industry PR. I think the government would actually be larger if it's duty was to try and education consumers so as to make responsible choices."
I completely agree that fines for hiding the info should be large enough to be a deterrent to doing so. Even short of that, though, the fact of the studies being hidden does(and should) expose the company to liability and punitive lawsuits from those damaged after the company found out the info but did not then respond responsibly. That's a huge exposure. And of course, with the risks now known, DuPont is now liable for any further damage it causes with such chemicals. And they know this, so having ramped their production up, they (a) ought to [if only for their own protection] be controlling the process better so that these chemicals are no longer released in significant amounts, and (b) can now be inspected or monitored by those who are concerned to see if this is the case.
As for the needs of the consumer today, the release of this type of information is the difference.
a) We are developing a media that had the time and space to report everything; you are part of that, along with the internet in general. Never has there been so much time and space and info for reportage.
b) We don't have a public that had the capacity to understand the scientific principles, but that's no one's fault but our own. We as people have to take responsibility for paying attention and understanding the real issues that affect us; it's not the government's responsibility or duty to do that for us.
c) Again, it's not the government's job to "counter the industry PR". It's up to concerned people or interest groups to raise issues that matter, and people can then respond as they see fit.
d) Yes I agree the government would probably be larger if its duty was to try and educate consumers so as to make responsible choices. But that's not its duty. Its duty is to ensure that relevant information is not hidden, and to adjudicate disputes and liability. It is the duty of consumers to educate themselves and each other.
PhilB
hmmm. I do know that immunosuppression in humans can be a very serious disease, with severe clinical manifestations.
yet i am a little bit puzzled. You describe a paper where they report immunosuppression from doses as low as ~ 2 microgrammes per kg per day for as little as 4 weeks. Yet there are two rat bioassays where there appears to be precious little evidence of immunosuppression at 1.4 and 5 milligrams/kg/day, after two years. cynomolgus monkeys given 150 microgrammes/kg/day for 90 days showed no obvious signs of immunocompetence.
it is almost enough to make a toxicologist enquire about the relevance of these findings on "immunosuppression".
per
Link missing in main post, that should be in this phrase:
"related to Teflon treatments (read more here), also"
we are thanking for the knowledge
You describe a paper where they report immunosuppression from doses as low as ~ 2 microgrammes per kg per day for as little as 4 weeks.