Tuesday, March 27, 2018

Science and Regulation at the EPA Today. . .

The New York Times had an Op Ed piece this past week written by two former EPA officials discussing a new tactic being embraced by Scott Pruitt and they fear will be adopted by other regulatory agencies. 


The new tactic in fighting or diminishing the EPA's regulatory regime is to challenge the science it is based upon. For Pruitt, the head of the EPA, (and also one of its biggest critics), and Republicans in Congress, transparency has become the rallying cry. You have to give them credit. Transparency. Has there ever been such an over-used word? Originally associated with the need for transparency in the halls of Congress and in financial transactions, Pruitt and the Republicans have now embraced and applied it to scientific research.

Actually it does seem like a reasonable request. Regulation should be based on publicly available science. It is not. Due primarily to two reasons: patient privacy rights, and intellectual property. In short we want to protect patients’ case histories being shared and discussed in public discussions. And the other is trade secrets, which in some cases businesses spent years and who knows how much on research to discover these drugs and chemical compounds. There is a reason they patent and protect such knowledge. Neither of these; neither patient details, nor patented products and copyrighted information should be shared and distributed publicly for obvious reasons.
Yet you do need to regulate these fields, these domains: the medical, the pharmaceutical and the chemical. The solution has been to engage in “secret science”, though peer reviewed, yet not publicly published, not publicly shared.
Pruitt and Republicans want to abandon this process of using non-published science. If it cannot be shared then it should not be the basis of regulation. There is a certain reasonableness to the request.
The consequence, however, is to simply abandon regulation. It basically forces regulators to use publicly available science. the challenge becomes with new research, new discoveries, there is little publicly available research. I don’t think any patients wants their medical records shared, though they might reconsider, considering the alternative, I.e. no or limited review of the research nor the resulting regulations to protect them from the new drugs and chemicals they are being offered.
Jump to the chemical industry which is regulated by Pruitt’s EPA. Due to their patents, the latest and greatest chemical compounds cannot be regulated. Insecticides, detergents, and the like, if they are new and we know little publicly, well the regulation will arrive in a few years, when we do have publicly available information. So out of a respect for the patent holder we must accept that we cannot have a regulatory regime. Not until we have publicly available research. What?
So in the the name of transparency pharma and the the chemical business have found an argument against not regulation, but the science that leads to it.
Ultimately, it comes down to trust. We traditionally and historically just trust science. We have up until now put our trust in the scientific method. In short, we have up  until now placed our faith in peer reviewed research or something close to it.
You have to give Pruitt and company credit. We boast about our peer reviewed research which typically entails journals. Yet we are compromising here.
Of course there must be some hypocrisy here also. Those same companies who developed those drugs and chemicals somehow developed them in secret. And yet the products are still considered the products of science.
At the root of this is an issue involving trust. Who do we trust? The pharma and chemical companies? Big government? Or the process we have created between the two? The later is an ongoing battle, between three parties. Those parties are pharma and chemical companies, the regulators, and the environmental groups. And the three of these will ultimately resolve this in court. So historically, we really have trusted that between these three, some good science, and a solid court system we would ultimately sort this out. and we acknowledge that project is never done. 
One does, however, pause when the validity of the science is questioned. And this is a common theme today. Yet perhaps a bit of skepticism is a good thing. To challenge and review the work done and considering how it is done, what is the actual process embraced by the scientists, is a good thing. The process we have in place will either stand and be reinforced by such a challenge or we will find the bugs and ultimately enhance the process. 
So despite my concerns about this assault on science and the issue of eliminating regulation based upon this attack, I do still have faith in the overall system and specifically our courts.I know that the environmental groups will not allow this without a court battle. So this will be sorted out, and I am pretty certain that science will continue to drive a proper regulatory regime. And I do see a certain legitimacy to the challenge of transparency and its lack in a secret science, That said, I am annoyed that they even try to challenge it. It being science. How could they(?) is my response.
So I wonder in the end if I am perhaps a bit dogmatic in my acceptance of science? It is perhaps a blind spot? It is possible that the EPA is doing shitty secret science? It would not be the first time, And Pruitt, the environmentalists, and the courts will sort through that and proceed. That is the hope. So yes I have little little use for Pruitt, and I do believe he is basically attempting to destroy and sabotage the very agency he supposedly directs and manages. 

That said, this exercise of looking at various processes and procedures might actually be a good thing. We might just find some issues, and will get to find out how resilient the system is, even with or especially with people on the inside trying to blow it up. 
This might truly be a case of that which does not kill us or the EPA, will make us or the EPA stronger. Maybe.

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