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Critical Condition: Science at the FDA
Critical Condition: Science at the FDA
Source: Catalyst, Fall 2006 Magazine of the Union of Concerned Scientists
Author: Michael Halpern
At one time in America, unscrupulous salesmen peddled elixirs and tonics that promised to cure
all ills. In truth, these "medicines" often contained opium, cocaine, and even uranium. The
federal government intervened and in 1906 passed a law that would eventually lead to the
creation of the U.S. Food and Drug Administration (FDA). Today, the agency's mission is to
ensure "the safety, efficacy, and security" of not only food and drugs, but also medical
devices, vaccines, cosmetics, and the U.S. blood supply.
Recent scandals related to FDA approval of drugs such as Vioxx and Plan B, however, have
shaken Americans' consumer confidence. Even worse, a recent Union of Concerned Scientists
(UCS) survey demonstrated that the agency's own scientists have little confidence in the FDA's
ability to protect public health.
Misplaced Priorities
Earlier this year, 997 FDA scientists responded to a survey from UCS and Public Employees
for Environmental Responsibility (PEER) about the state of science at the agency. The
scientist paint a troubling picture: hundreds reported significant interference in their scientific
work and many expressed concern that the agency's decisions ignore or misrepresent the best
available science.
Among the more disturbing findings:
561 scientist thought their mangers did not consistently stand behind the scientist's work
when it was scientifically defensible but politically controversial.
357 scientists felt they could not openly express any concerns about public health-even
inside the agency-without fear of retaliation.
145 scientists said they have been asked to inappropriately exclude or alter information
from a scientific report
378 scientists thought the FDA is not acting effectively to protect public health
"Science must be the driving force for decisions made at the FDA", says Francesca Grifo,
senior scientist and director of the USC Scientific Integrity Program. "FDA leaders should act
now to improve transparency and accountability and renew respect for independent science at
the agency."
The Message Is Heard
Before the release of the survey on July 20, UCS met with several members of Congress to
inform them of the results and urge swift and meaningful reform at the FDA. Both Republicans
and Democrats have since demanded that the agency listen to its scientists and move quickly
to improve morale, protect scientists who speak out, and restore its scientific integrity.
In August, UCS briefed acting FDA Commissioner Andrew von Eschenback on the survey
results and suggested specific reforms (see below). Dr. von Eschenbach expressed his own
concern and invited UCS to re-evaluate the situation in six months.
We will indeed continue to monitor this FDA to ensure it continues to set the gold standard for
protecting and improving Americans' health and safety. Without concrete reforms that ensure
accurate and independent scientific analysis, the FDA cannot fulfill its mission, and our health
is put at risk.
The FDA scientist survey is one in a series designed to examine the degree of political
interference in science at federal agencies. To view detailed results from all of these surveys
or to learn more about our efforts to restore scientific integrity in federal policy making, visit the
UCS website at www.ucsusa.org/surveys
Michael Halpern is outreach coordinator for the Scientific Integrity Program
Protect Science at the FDA
Issue:
This summer, UCS staff briefed Andrew von Eschenback, acting commissioner of the Food and
Drug Administration, on the results of our recent survey of scientists within his agency. Dr von
Eschenback voiced his intention to address these concerns and communicated his desire for
the FDA to remain a science-led organization.
We are encouraged that Dr. von Eschenback acknowledged and understood his scientists'
concerns; now we need to make sure he follows through with changes that protect scientists,
improve morale, and restore scientific integrity to the agency. At a minimum, he should commit
the FDA to:
Ensure that data or results are never softened for any audience
Take adverse employment action against any manager who retaliates against an FDA
scientist for speaking out about scientific abuse and
Maintain a culture that supports a collaborative process of testing and challenging scientific
hypotheses.
Action:
Contact Dr. von Eschenback and urge him to take concrete steps to restore scientific integrity
to the FDA. Tell him that our public health and safety depend on an open scientific process
and rigorous scientific debate. Mail your letter to:
Dr. Andrew von Eschenback
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Source: Catalyst, Fall 2006 Magazine of the Union of Concerned Scientists
Author: Michael Halpern
At one time in America, unscrupulous salesmen peddled elixirs and tonics that promised to cure
all ills. In truth, these "medicines" often contained opium, cocaine, and even uranium. The
federal government intervened and in 1906 passed a law that would eventually lead to the
creation of the U.S. Food and Drug Administration (FDA). Today, the agency's mission is to
ensure "the safety, efficacy, and security" of not only food and drugs, but also medical
devices, vaccines, cosmetics, and the U.S. blood supply.
Recent scandals related to FDA approval of drugs such as Vioxx and Plan B, however, have
shaken Americans' consumer confidence. Even worse, a recent Union of Concerned Scientists
(UCS) survey demonstrated that the agency's own scientists have little confidence in the FDA's
ability to protect public health.
Misplaced Priorities
Earlier this year, 997 FDA scientists responded to a survey from UCS and Public Employees
for Environmental Responsibility (PEER) about the state of science at the agency. The
scientist paint a troubling picture: hundreds reported significant interference in their scientific
work and many expressed concern that the agency's decisions ignore or misrepresent the best
available science.
Among the more disturbing findings:
561 scientist thought their mangers did not consistently stand behind the scientist's work
when it was scientifically defensible but politically controversial.
357 scientists felt they could not openly express any concerns about public health-even
inside the agency-without fear of retaliation.
145 scientists said they have been asked to inappropriately exclude or alter information
from a scientific report
378 scientists thought the FDA is not acting effectively to protect public health
"Science must be the driving force for decisions made at the FDA", says Francesca Grifo,
senior scientist and director of the USC Scientific Integrity Program. "FDA leaders should act
now to improve transparency and accountability and renew respect for independent science at
the agency."
The Message Is Heard
Before the release of the survey on July 20, UCS met with several members of Congress to
inform them of the results and urge swift and meaningful reform at the FDA. Both Republicans
and Democrats have since demanded that the agency listen to its scientists and move quickly
to improve morale, protect scientists who speak out, and restore its scientific integrity.
In August, UCS briefed acting FDA Commissioner Andrew von Eschenback on the survey
results and suggested specific reforms (see below). Dr. von Eschenbach expressed his own
concern and invited UCS to re-evaluate the situation in six months.
We will indeed continue to monitor this FDA to ensure it continues to set the gold standard for
protecting and improving Americans' health and safety. Without concrete reforms that ensure
accurate and independent scientific analysis, the FDA cannot fulfill its mission, and our health
is put at risk.
The FDA scientist survey is one in a series designed to examine the degree of political
interference in science at federal agencies. To view detailed results from all of these surveys
or to learn more about our efforts to restore scientific integrity in federal policy making, visit the
UCS website at www.ucsusa.org/surveys
Michael Halpern is outreach coordinator for the Scientific Integrity Program
Protect Science at the FDA
Issue:
This summer, UCS staff briefed Andrew von Eschenback, acting commissioner of the Food and
Drug Administration, on the results of our recent survey of scientists within his agency. Dr von
Eschenback voiced his intention to address these concerns and communicated his desire for
the FDA to remain a science-led organization.
We are encouraged that Dr. von Eschenback acknowledged and understood his scientists'
concerns; now we need to make sure he follows through with changes that protect scientists,
improve morale, and restore scientific integrity to the agency. At a minimum, he should commit
the FDA to:
Ensure that data or results are never softened for any audience
Take adverse employment action against any manager who retaliates against an FDA
scientist for speaking out about scientific abuse and
Maintain a culture that supports a collaborative process of testing and challenging scientific
hypotheses.
Action:
Contact Dr. von Eschenback and urge him to take concrete steps to restore scientific integrity
to the FDA. Tell him that our public health and safety depend on an open scientific process
and rigorous scientific debate. Mail your letter to:
Dr. Andrew von Eschenback
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857