EPA to make regulatory decisions using questionable science

Research transparency is a core value at The Michael J. Fox Foundation for Parkinson’s Research. Across our programmatic activity, where we will soon hit the $1-billion mark in funded research, we build in requirements for scientists to adopt a collaborative and transparent stance to the greatest extent possible to speed knowledge turns, foster replication, and deepen the public’s trust in findings. 

I was on Capitol Hill recently urging the House Committee on Science, Space and Technology not to enact the Environmental Protection Agency’s proposed transparency rule, disingenuously titled “Strengthening Transparency in Regulatory Science.” Why?

While seeming to stand for the widely acknowledged good of greater research transparency, it actually will force EPA to make regulatory decisions based on less information, which compromises the agency’s mission and promise. 

The rule would exclude large swaths of medical research where longstanding and critical privacy protocols mean data cannot be shared without compromising the privacy of the everyday people who participate in studies. This should be unacceptable to every American family touched by disease — that is, every single one of us.

To give just one example: epidemiological and population-based studies form the bedrock of knowledge for determining the environment’s impact on human health. 

We believe most, if not all, Parkinson’s cases arise from a combination of genetic and environmental factors. For this reason, census data and epidemiological studies are crucial to better understanding potential causes of Parkinson’s. 

However, data collected through these studies cannot always be adequately de-identified and therefore must be protected and not publicly shared. If they were shared, participants are at risk for having their diagnosis exposed to the public.

Kevin Kwok, a patient advocate, was diagnosed with Parkinson’s at age 46. He spent college summers hauling toxic waste drums at a well-known chemical company. Even with protective outerwear, and following OSHA safety guidelines, he had direct contact with chemical reagents every day. 

While we can’t say with certainty that the job had a direct impact on Kevin’s diagnosis, with more research we may know in the future how these exposures contributed to his disease. Kevin is an avid research participant with hopes that his contributions can inform not only the science of Parkinson’s, but also policy decisions that impacts people living with the disease, or at risk. 

It is clear that this rule would have a chilling effect on our ability to continue unpacking the connections between environmental factors and disease. 

Thousands of studies would be excluded from the EPA’s evaluation process. In Parkinson’s alone, dozens of studies link the disease to pesticide exposure, but many or most would not be admissible under the proposed rule. 

A 2009 study showed that consuming water from a private well in an area with historical pesticide use was associated with an increased risk of Parkinson’s. Wells typically serve a limited number of people within a very small radius; therefore, proper de-identification is impossible. 

Simply knowing one individual lives near a particular well, coupled with knowing their age or gender, would quickly expose the identity of a person with Parkinson’s.

What’s more, if the EPA’s rule takes effect, studies that rely on people revealing sensitive or private information may have difficulty recruiting or retaining volunteers when they learn that the researchers will be required to make data publicly available. 

It is entirely possible that those who are willing to participate under these circumstances may be different from others, which could introduce bias that confounds results in unexpected ways.

Our foundation finds that patients are eager to participate in responsible sharing of appropriately de-identified data. With the consent of 1,500 patient and control volunteers, our Parkinson’s Progression Markers Initiative study makes all de-identified data available to the research community in real time.

Scientists worldwide have downloaded data from the study more than five million times and used it in more than 150 published papers. We share that data — and encourage our funded researchers to make data available — entirely based on the feasibility of de-identification.

People with Parkinson’s disease have every right to keep their diagnosis private until they are ready to share it publicly. They also have a right to demand protections against environmental toxins that raise disease risk. 

Our foundation takes seriously our obligation to those living with Parkinson’s disease, and we expect nothing less of the federal government. Ensure the EPA continues to balance the need for scientific transparency with its duty to protect the health of Americans. Do not enact this rule.

Todd Sherer is the CEO of The Michael J. Fox Foundation for Parkinson’s Research. The Foundation is the world’s largest nonprofit funder of Parkinson’s research.