For Immediate Release
New Report Urges FDA Clinical Trial Reform
WASHINGTON - Today, the Government
Accountability Project (GAP) is releasing a new "white
paper" report, The
ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment,
which focuses on the severe problems with the current system for conducting and
regulating clinical trials. The report details the urgent need for
Click here to read a copy of the new report's
executive summary: http://www.whistleblower.org/
Click here to read a copy of the new report: http://www.whistleblower.org/
Mark Cohen, GAP Executive Director and coauthor of the
report, stated "The current clinical trial reform process is rife with
conflicts of interest that put trial subjects at risk and produce suspect data
on drug safety and efficacy. Making matters worse, federal oversight is wholly
The report examines a number of recent and historical
controversies with regard to clinical trial studies and institutional review
boards (IRBs) - analyzing how major players at both the corporate and FDA
levels have too often failed to perform their critical duties to safeguard
human health. More importantly, GAP's report proposes constructive
reforms to the overall process, calling for the empowerment of trial
participants, whistleblower protections for employees staffing trials and IRBs,
removal of financial conflicts of interest between parties, and trial biases in
favor of approval of proposed drugs. Specifically, our report advocates for:
Whistleblower Protections for all Involved Parties:
Stronger anti-retaliation measures for those with evidence of wrongdoing
and threats to public health are essential to weed out bad faith parties.
Recourse for Injured Trial Participants: The Supreme
Court held that state court personal injury lawsuits against medical
device makers are preempted if the product is FDA approved. Congress must
intervene on patient's behalves, and ensure adequate protections to
trial participants of such devices.
Government Protections of all Clinical Trial Participants: An estimated 40 percent of
studies and over five million research participants are left uncovered each year.
Reform of IRBs: A number of structural, financial,
procedural, and regulatory gaps plague the IRB system.
- Greater Monitoring of IRB "Informed Consent" Practices: The
current IRB system focuses almost exclusively on the review of consent
forms. Yet, the law does not require IRBs to regularly observe consent
interviews or the conduct of study protocols.
- "Non-Inferiority Trial" Reform: The
FDA currently permits the drug industry to prove the efficacy of a new
drug by comparing it to a previously approved drug for the same
indication, even where comparison to a placebo would not endanger the
subject. Rather than requiring the new drug to be superior to the
comparator drug, if the new drug is within a margin of inferiority the FDA
deems acceptable, the agency will approve it. Approval of such a drug adds
no value for patients but it does provide a mega-dollar benefit to drug
IRB protocols have been a hot topic in the news. Two
weeks ago, it was uncovered at a House of Representatives hearing that the
Government Accountability Office, as part of a sting operation, created
multiple fake companies and drugs, submitted them for approval using three
third-party IRBs, and successfully received permission to begin clinical trial
use in patients. Also two weeks ago, the FDA released a progress report
regarding its Human Subject Protection and Bioresearch Monitoring Initiative. While some of its recommendations
represent progress, GAP still identifies major gaps to public safety.
"The FDA system of ensuring drug safety is a
work-in-progress," stated Sheila Fleischhacker, author of the report.
"Some of the FDA's new regulations are steps in the right
direction, but the overall process still has too many gaps that put the public
at risk. Our report can be viewed as a piece to continue the initiative's
modernizing and strengthening."
The Government Accountability Project (GAP) is a 30-year-old nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists. We pursue this mission through our Nuclear Safety, International Reform, Corporate Accountability, Food & Drug Safety, and Federal Employee/National Security programs. GAP is the nation's leading whistleblower protection organization.