| July 14, 2010 |  |
Avandia Hearing Reveals Fundamental Flaws at FDA
WASHINGTON (July 14, 2010) – Hearings by a Food and Drug Administration (FDA) advisory panel on the safety of a diabetes drug illustrate fundamental flaws in the way the agency reviews pharmaceuticals, according to the Union of Concerned Scientists (UCS).
The advisory panel met yesterday and today to review safety questions regarding Avandia, a GlaxoSmithKline diabetes drug that has been linked to heart attacks, strokes and deaths. The panel is charged with recommending whether or not the agency should pull the drug off the market.
“Avandia is a prime example of how the FDA has failed to protect the public,” said Francesca Grifo, director of UCS’s Scientific Integrity Program. “In this case, the agency took too long to act, and ignored its own scientists’ concerns and recommendations.
“We need fundamental change at the FDA,” she added. “That will take guidance from the top, and we’ve been waiting for more than a year for the administration’s scientific integrity action plan.”
The agency was first warned about Avandia’s adverse affects four years ago. In February 2006, Dr. Rosemary Johann-Liang, then-deputy director of the FDA’s Drug Risk Evaluation division, recommended that the agency require GlaxoSmithKline to place a “black box” warning on the drug about possible heart problems related to the drug. Not only did the FDA fail to act on this recommendation, Johann-Liang was reprimanded by FDA safety review managers.
Two years later, two FDA scientists raised concerns about the agency’s 2007 directive to GlaxoSmithKline to undertake a large-scale study of the drug’s safety. The scientists warned that the study posed an unnecessary risk to test subjects. The FDA dismissed their concerns.
“For too long, FDA officials have allowed corporations to subvert scientific outcomes, which has harmed thousands of Americans and shaken the public’s faith,” Grifo said. “We have a new administration in office, and in spite of efforts by FDA leadership, it is still business as usual at the agency.”
Yesterday, the Senate Finance Committee revealed that GlaxoSmithKline executives “intimidated independent physicians, minimized findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug might reduce cardiovascular risk.”
“Over the past five years, FDA scientists who have questioned the safety of drugs such as Avandia, Vioxx and Ketek were not only were ignored, they were intimidated and censored,” said Grifo. “In each case, their concerns were justified, but they were heeded only after thousands of patients died or were seriously harmed.”
Grifo offered a number of recommendations for improving FDA procedures and protecting agency scientists:
- The FDA commissioner must instruct agency managers to refrain from retaliating against whistleblowers through reassignments, demotions or terminations.
- The FDA commissioner should issue a statement that encourages staff to speak out internally about concerns and communicate that the agency values their input.
- FDA staff members should feel empowered to report not just waste, fraud and abuse, but also instances in which science has been manipulated, suppressed or distorted.
- The FDA should educate its scientists and researchers about their rights and protections. These efforts should include mandatory briefings for new hires, requirements for posting educational information in workplaces, and in-service trainings.
“It is time for the agency to give its own scientists the respect they deserve when they raise red flags about the drugs they’re evaluating,” Grifo said. “The FDA also must stop allowing pharmaceutical companies to put profit over patients.”
The Union of Concerned Scientists puts rigorous, independent science to work to solve our planet's most pressing problems. Joining with citizens across the country, we combine technical analysis and effective advocacy to create innovative, practical solutions for a healthy, safe, and sustainable future.
