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 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, said Dr. Renee Salas, the lead
author on an opinion piece published in the Annals of Internal
Medicine.
Salas, an emergency medicine physician at the Massachusetts General
Hospital and a researcher with the Harvard Global Health Institute
in Boston, told 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," Salas said.
If the rule is passed, the data used in studies must be made
available to anyone who wants to "independently validate the
research," Salas said. "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 live--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."
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Beyond that, Salas said, 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, Salas said.
This issue is "really important," said Thomas Burke, 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 in Baltimore. 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," Burke
said. 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," Burke said. "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."
While transparency should be strived for, it's not always possible,
Burke said. "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.
SOURCE: http://bit.ly/2FUvll1 Annals of Internal Medicine, online
January 28, 2019.
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