(Reuters Health)—A new rule proposed by the U.S. Environmental Protection Agency (EPA) may make it almost impossible to uncover hazards such as dirty air, polluted water and environmental toxins, researchers say.
The rule mandates that all underlying data from studies be made available to any and all researchers in the interests of transparency. But while transparency is generally a laudable goal, the rule may be used to throw out older studies for which data is no longer available and newer studies with data that can’t be shared because of patient privacy issues, says Renee Salas, MD, MPH, MS, the lead author on an opinion piece published in Annals of Internal Medicine, Jan. 28.1
Dr. Salas, an emergency medicine physician at the Massachusetts General Hospital and a researcher with the Harvard Global Health Institute, Boston, tells Reuters Health the new rule would be “turning the existing system on its head.”
“Instead of being automatically considered, a study that uses protected health information or human subjects cannot be considered except on a case by case basis,” Dr. Salas says.
If the rule is passed, the data used in studies must be made available to anyone who wants to “independently validate the research,” Salas says. “But to do that would erode patient confidentiality, which we as researchers have a mandate to protect.”
Many studies, for example, don’t include participants’ names, but do include information about where they liv—which is necessary if a researcher is trying to discern possible health hazards due to pollution. If the data is made available with the patient addresses, that would violate confidentiality. But if researchers don’t know how far people live from a potential source of pollution, they won’t be able to connect symptoms with the environmental hazard.
The researchers point to the example of the Harvard Six Cities Study, which determined that fine particle pollution in the air was strongly and consistently linked to an increased risk of death. That study “was fundamental to the EPA’s implementation of the Clean Air Act, and the evidence is clear: the stringent air regulations improved health and saved lives,” Salas and her colleagues wrote. “Although the Six Cities Study has been heralded as transparent, high quality science, the proposed rule would have excluded it from the EPA’s consideration.”
Beyond that, Dr. Salas says, many of the EPA’s regulatory decisions have been based on decades-old studies for which the raw data are no longer available.
While the EPA has argued that patient data can be de-identified, studies have shown that sometimes patients’ identities can be discerned from the information that is included, Dr. Salas says.
This issue is “really important,” says Thomas Burke, PhD, a professor and chair in health risk and society and director of the Risk Sciences and Public Policy Institute at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Dr. Burke, who was not affiliated with the new article, is a former science advisor and head of research and development at the EPA.
“Basically, this rule gives incredible authority to the administrator of the EPA to say what is in and what is out,” Dr. Burke says. What is kicked out “could include enormous amounts of historical data on lead and mercury because it’s virtually impossible to retrieve the original data.”
“Many opponents of regulation have for the good part of the last 50 years tried to pick at the data,” Dr. Burke says. “That started with the cigarette companies denying that tobacco caused lung cancer and has continued all the way through agriculture and chemical producers challenging the effects on the brain of certain pesticides.”
Although transparency should be strived for, it’s not always possible, Dr. Burke says. “This rule would be really harmful to the evidence base and potentially to the protection of health.”
The EPA did not respond to a request for comment.
- Salas RN, Laden F, Jacobs WB, et al. The U.S. Environmental Protection Agency’s proposed transparency rule threatens health. Ann Intern Med. 2019 Jan 29. doi: 10.7326/M18-2673. [Epub ahead of print]