For Immediate Release

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Dylan Blaylock
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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:

Click here to read a copy of the new report:


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:

  • Greater
    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.
  • Legal
    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. 
  • Federal
    Government Protections of
    all Clinical Trial Participants: An estimated 40 percent of
    studies and over five million research participants are left uncovered each year.
  • Legislative
    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."


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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.

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