The ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment

(Washington, D.C) – 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 reform. 

Click here to read a copy of the report's Executive Summary:http://www.whistleblower.org/doc/2008/ABCExecSum.pdf 

Click here to read a copy of the new report in full:http://www.whistleblower.org/doc/2008/ABCFinal040709.pdf 

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 inadequate.”

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 companies.
  

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. During that same week, 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.”

Government Accountability Project

The Government Accountability Project is the nation’s leading whistleblower protection organization. Through litigating whistleblower cases, publicizing concerns and developing legal reforms, GAP’s mission is to protect the public interest by promoting government and corporate accountability. Founded in 1977, GAP is a non-profit, non-partisan advocacy organization based in Washington, D.C.