Matthew is an associate editor of The American Journal of Managed Care® (AJMC®). He has been working on AJMC® since 2019 after receiving his Bachelor's degree at Rutgers University–New Brunswick in journalism and economics.
The EPA proposal to limit science used in rulemaking was discussed by panel members during a hearing held today by the House Committee on Science, Space, and Technology, with patient confidentiality serving as a major issue.
This week's EPA proposal to limit science used in rulemaking was discussed by panel members during a hearing held by the House Committee on Science, Space, and Technology, with patient confidentiality serving as a major issue.
A draft of the EPA proposal, titled “Strengthening Transparency in Regulatory Science,” would require scientists to disclose all of their raw data, including confidential medical records, before the agency could consider the conclusions derived from the academic study. EPA officials have explained their intentions behind the rule as a step toward transparency and said the disclosure of raw data would allow conclusions to be verified independently.
As The New York Times reports, the measure would make it increasingly difficult to enact new clean air and water rules as many studies detailing the links between pollution and disease rely heavily on personal health information gathered under confidentiality agreements. Paul Billings, senior vice president for advocacy at the American Lung Association, explained that “this means the EPA can justify rolling back rules or failing to update rules based on the best information to protect public health and the environment, which means more dirty air and more premature deaths."
One major study that discovered the link between polluted air and premature deaths, the 1993 Harvard University Six Cities study, would subsequently be discounted for consideration under the rule proposal as scientists signed confidentiality agreements to track the private medical and occupational histories of more than 22,000 people in the 6 cities.
Today, the House Committee on Science, Space, and Technology held a hearing titled “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking” in which panel members discussed the issues correlated to the proposal.
Panelist Todd Sherer, MD, CEO of The Michael J. Fox Foundation for Parkinson Research, spoke extensively to how the rule change would heighten the risk of exposure for patients who want to participate in clinical studies, especially those recently diagnosed as symptoms for Parkinson disease are known to develop slowly, which allows patients to continue working and remain leaders in their communities.
“They have every right to keep their diagnosis private and still participate in research, but the EPA’s proposed rule puts these individuals at great risk of having their Parkinson diagnosis exposed. Such exposure could result in unfair job loss, lowballing into a loss of income, insurance, and other life-altering consequences. It is vital that we protect patients’ right to privacy,” said Sherer.
The move would give EPA Administrator Andrew Wheeler, MBA, expansive authority over which studies to accept or reject. Michael Halpern, deputy director for the Center for Science and Democracy at the Union of Concerned Scientists, strongly opposed the proposal stating, “this is a wholesale politicization of the process,” while additionally adding, “it was hard to imagine that they could have made this worse, but they did,” said Halpern.
Currently, there is no requirement from academics to turn over private data when submitting studies for peer review by other specialists in the field or for publication in scientific journals. If this would become required, a federal estimate details that the EPA would have to spend hundreds of millions of dollars to redact private information during public review.
The proposal allows the public 30 days to offer comments on the changes to the EPA plan, with agency officials hoping to finalize the measure in 2020.
“Some of the data collection may have started decades ago and you can’t really go back in time to re-consent and re-set up the rules about that data. So, I think 1 of the concerns is you’d still want to be able to use that data if you’re changing the rules going forward on what is required with sharing. You can’t go back 30 years when you started collecting the data,” said Sherer.