Managers in FDA's device center "ignored and suppressed" significant public health concerns about imaging systems in their past reviews of some such devices, according to a scientist who spoke at a recent FDA meeting.

The scientist, Julian Nicholas, a gastroenterologist at the Scripps Clinic in San Diego, spoke at a meeting hosted by the agency to discuss unnecessary radiation exposure from medical imaging, particularly computed tomography scans.

"More than one year ago, FDA physicians and scientists raised serious safety and effectiveness concerns about patients receiving radiation from CT devices," Nicholas said during the first day of the March 30-31 meeting. "These concerns were ignored and then suppressed."

Nicholas worked on contract as a medical reviewer in FDA's Reproductive, Abdominal and Radiological Devices review branch from October 2006 through October 2009. He was hired as part of the agency's Medical Devices Fellowship Program, according to FDA staff rosters.

According to Nicholas, FDA scientists had warned CDRH of the danger of exposing healthy, asymptomatic patients to high doses of radiation from CT, including risks of radiation-induced cancer. They also warned of inadequate safety labeling for CT devices and a lack of valid scientific evidence for the use of CT in colorectal cancer screening, he said.

In a Dec. 11, 2009, ¹ letter to HHS Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg leaked on the blog Pharmalot, Nicholas noted that he was one of two medical officers who reviewed an imaging device intended to screen patients for colorectal cancer.

Reviewers' concerns reportedly involved a pre-market application from GE Healthcare to allow use of CT scanning for colon cancer screenings.

When Nicholas raised concerns about screening asymptomatic patients with CT, which delivers a radiation dose hundreds of times greater than that of a typical chest x-ray, CDRH managers "chastised my concerns as raising the bugaboo of radiation," he said.

Alberto Gutierrez, director of FDA's diagnostics office, which recently assumed oversight of all radiology devices, told "The Gray Sheet" the GE device has not been cleared or approved for colon cancer screening, but noted that at least two other CT devices have been cleared for this indication.

The March 30-31 public meeting was chaired by Sean Boyd, chief of the diagnostic devices branch in CDRH's division of mammography quality and radiation programs.

CDRH Director Jeffrey Shuren also sat in.

A "Distorted" Review Process?

Nicholas mapped out the interactions between FDA scientists and managers from about March 2009 to late October, painting a picture of a "distorted" device review process.

"The scientific and regulatory review process for medical devices was being distorted by managers who are not following the laws, rules and regulations," Nicholas told meeting attendees.

"By June, FDA physicians and scientists felt they were being pressured and coerced to change their scientific recommendations," he said.

Ultimately, some of the scientists and physicians were terminated from their positions at FDA, "including myself," he said.

They appealed "to the highest levels of FDA to intervene," including the agency's chief scientist and then-acting director Shuren, but "to no avail," Nicholas said.

FDA spokesman Dick Thompson noted that Nicholas' contract with the agency was time-limited and, at the end of it, was not renewed.

"Science Must Not Be Ignored" - FDA Staffer

Another public speaker at the meeting, Robert Smith, a medical officer in the agency's radiological devices branch, applauded Nicholas' willingness to come forward with his concerns.

According to earlier press reports, several other FDA whistleblowers had been planning to air their concerns at the meeting.

"I hope the agency will learn something from [Julian's] experience," Smith said.

"Science must not be ignored, suppressed or distorted," he said. "FDA must follow the laws, rules and regulations. Otherwise, the public is at risk."

Smith expressed concerns that, despite the potential benefits of CT technology, "it is a technology that has been misused by physicians."

FDA has no data demonstrating that CT systems are safe and effective for general screening of asymptomatic patients, he said.

And while the agency cannot regulate the practice of medicine, it can assure that no CT devices are indicated for use as a general screening tool without "valid scientific evidence to show the device is safe and effective for that clinical indication," Smith concluded.

OIG Clears FDA Managers Of Illegal Conduct

The testimony from Nicholas and Smith was reminiscent of previous complaints from a group of device center reviewers.

In fall 2008, about nine whistleblower scientists went public with accusations that CDRH managers had coerced and intimidated staffers into changing their scientific opinions. The group approached the heads of FDA and members of Congress about the matter, as well (² Also see "“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe" - Medtech Insight, 24 November, 2008.).

There are signs that the new CDRH leadership is treating the accusations of management misconduct seriously.

According to a recent agency statement, FDA referred the allegations of unfair treatment and retaliation against agency scientists to the Office of Inspector General for the Department of Health and Human Services for evaluation.

The inspector general concluded that FDA managers violated no laws or agency policies in their interactions with the dissident scientists and reviewers, the agency confirmed last week.

"The Office of Inspector General evaluated these concerns and found no evidence of potential violation of law, prohibited personnel practices or retaliation," FDA's statement said.

The agency indicated it remains concerned about the issue, saying "it is not acceptable to penalize scientists for expressing their scientific views."

FDA had planned to train employees on a new set of ³ standard operating procedures for resolving internal differences of opinion on regulatory decisions by February (⁴ Also see "CDRH Acting Director Jeffrey Shuren Vies For Permanent Spot" - Medtech Insight, 19 October, 2009.).

And while it is not clear how much progress device center managers have made in regaining the trust of the review staff, it seems apparent that they now share scientists' concerns about risks of excessive radiation.

On Feb. 9, center director Shuren announced a new safety initiative to reduce unnecessary radiation exposure to patients, in particular from CT, fluoroscopy and nuclear medicine. The March 30-31 public meeting was billed as the first step in the safety effort (⁵ Also see "FDA To Set Standards For CT, Fluoroscopic Devices In Radiation Safety Effort" - Medtech Insight, 15 February, 2010.).

- Jessica Bylander ( ⁶ j.bylander@elsevier.com )

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