A group of nine FDA scientists has sent letters to top politicians, accusing agency managers of intimidating and coercing scientists into changing or suppressing scientific data. In October, the scientists sent a letter to the House Energy and Commerce Committee. In early January, they sent another to then-president-elect Barack Obama.
The medical device review process, in particular, has been “corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the letter to Obama reads.
For example, the FDA continues to approve the use of certain mammography computer-aided detection devices for breast cancer screening, over repeated objections from agency doctors and scientists that there is no clinical evidence that the devices work as advertised.
According to the scientists, FDA employees are regularly pressured to conform to their managers’ agendas for medical devices, and are discouraged from raising safety concerns that management does not want to hear. The most recent letter alleges that employees who fail to follow the party line are often threatened with disciplinary action.
“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” the second letter says.
The letter writers say that although they have complained directly to FDA Commissioner Andrew von Eschenbach and Assistant Commissioner for Accountability and Integrity Bill McConagha, many of the most delinquent managers have since been promoted or otherwise rewarded. No one has been disciplined.
The nine scientists have called for a fundamental restructuring of the process for evaluating and approving medical devices, and for increased protection for government whistleblowers.
The FDA has come under increasing criticism in recent years, with both Democrats and Republicans accusing it of suppressing its scientists’ safety data in order to approve products for the benefit of industry. Leaders of the House Energy and Commerce Committee have written to von Eschenbach, saying that the scientists’ letter provided “compelling evidence of serious wrongdoing.”
Sources for this story include: online.wsj.com.