Experts Debate Extent of FDA Reform in Wake of Whistleblower Testimony

April 05, 2010

April 5, 2010 — Did a former consulting scientist at the US Food and Drug Administration (FDA) lose his position — as he contends — because he blew the whistle about the risk for radiation exposure from computed tomography (CT) scanners used in colon cancer screenings?

Or is the FDA right when it claims that the Department of Health and Human Services (HHS) found no criminal wrongdoing after investigating the charges of Julian Nicholas, MD, who testified March 30 at an agency hearing on preventing unnecessary radiation exposure from medical imaging?

Although all the facts surrounding the case of Dr. Nicholas have yet to be sorted out, some FDA watchers say one thing is clear — the agency is still recovering from the antiregulatory, probusiness climate of the George W. Bush administration in which public health took a back seat.

"The new leadership of the FDA inherited a mess," said Diana Zuckerman, PhD, president of the nonpartisan National Research Center for Women and Families, which specializes in health issues. "You have a change of leadership at the top, but the vast majority of the people in the FDA at the office or center level are exactly the same [as before]."

"People got promoted during the 8 years of the Bush administration for reasons that had to do with ideology. They may be very capable and smart, but they also have a proindustry point of view, not a public-health point of view."

Like Dr. Zuckerman, Steven Nissen, MD, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, in Ohio, and a long-time FDA critic, thinks that the Nicholas case is a sign of a hangover from the Bush administration.

"I believe the agency lost its way during the Bush years," Dr. Nissen told Medscape Medical News. And like Dr. Zuckerman, Dr. Nissen sees promise in the 2 people President Barack Obama picked to salvage the agency — FDA Commissioner Margaret Hamburg, MD, and Principal Deputy Commissioner Joshua Sharfstein, MD.

"Dr. Hamburg and Dr. Sharfstein are exceedingly well intentioned," said Dr. Nissen. "They are very independent and unlikely to be influenced by political considerations. They're a step up in quality compared to what we've seen over the past decade."

"But it's challenging for the new leadership to turn this giant battleship around when so many people in the infrastructure don't have a public-health perspective."

Dr. Nicholas Warned Virtual Colonoscopies Could Increase Cancer Risk

Dr. Nicholas is a gastroenterologist at the Scripps Clinic in San Diego, California, who consulted on the side for the FDA from 2006 to 2009, serving as its medical review officer for gastrointestinal devices. As such, he reviewed colorectal screening devices that came before the agency.

The FDA hearing at which he spoke last week was part of the agency's new campaign to reduce unnecessary radiation exposure from CT scans, nuclear medicine studies, and fluoroscopy. Those 3 modalities have mostly accounted for an almost 2-fold increase in nationwide exposure to ionizing radiation during the past 2 decades, according to a March 2009 report from the National Council on Radiation Protection and Measurements.

The 2-day hearing was designed to solicit ideas on new safety requirements for product design and clinician training that the agency could impose on manufacturers of CT and fluoroscopic equipment. However, the meeting took a contentious turn when Dr. Nicholas accused the agency of turning a blind eye to patient safety.

Dr. Nicholas said that his superiors in the agency's Center for Devices and Radiological Health pressured him to change his scientific opinion when he objected to letting a manufacturer — reportedly General Electric — market a CT scanner for "virtual colonoscopies." Nicholas said he warned FDA managers last year that such scans could significantly increase a patient's risk for cancer. His whistleblowing, he said, led the FDA not to renew his contract when it expired last October.

The testimony repeated charges that Dr. Nicholas made in a letter last December to HHS Secretary Kathleen Sebelius and FDA Commissioner Hamburg. He disclosed that he had sought an FDA warning label on the CT scanner in question that would highlight the risk for radiation-induced cancer, noting that between 1.5% and 2% of all cancers "are directly attributable to radiation exposure from CT scanning."

"You could imagine the appalling consequence," Dr. Nicholas wrote Ms. Sebelius and Dr. Hamburg, "of clearing a device that may not be as effective as [optical] colonoscopy, that may be misused to actually prevent patients from being studied with colonoscopy, and that may also cause radiation-induced cancer."

"I was continually harassed and pressured to change my review by managers, but because of my commitment to the public, I could not in good conscience do so, absent a valid scientific reason. I was intimidated and ultimately suffered the most severe form of retaliation against any employee engaged in whistleblowing activity — termination."

In the letter, he chided Dr. Hamburg for not holding "rogue managers" accountable for their actions. "This is contrary to Dr. Hamburg's public statements that she would create an environment in which scientists can raise their concerns free from fear and free from retaliation," he wrote.

On the same day that Dr. Nicholas testified at the FDA hearing last week, the agency released a statement reporting that it had referred allegations of retaliation against scientists to the Office of the Inspector General (OIG) at HHS. "The [OIG] evaluated these concerns and found no evidence of potential violation of law, prohibited personnel practice, or retaliation," the FDA statement read. It also noted that FDA scientists sometimes disagree "on the safety and effectiveness of products under review" and that the agency encourages "discussion of differing scientific viewpoints."

An agency spokesperson said that for the sake of creating a more transparent and open workplace, the FDA would hire a consultant to investigate allegations not addressed by the OIG and solicit employee feedback on issues such as trust, communication, manager–staff relations, policies and processes, organizational structure, and performance.

Earlier Whistleblowers Have Called the FDA Beholden to Industry

Dr. Nicholas's allegations were riveting, but they are not new. In a series of group letters to Congress and the White House going back to 2008, FDA physicians and scientists depicted the FDA as a broken, corrupt institution more beholden to medical device manufacturers and the politicians that lobbied on their behalf than to the public it was supposed to protect.

An April 2 letter to President Barack Obama stated that despite new leadership at the very top, the agency still abounded with veteran managers who have "violated laws, rules and regulations; who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out." The letter recommended disciplinary action against such employees, adding that some cases might need to go to the US Attorney General's office.

The portrait of the FDA that emerges from the letters matches Dr. Zuckerman's view of the agency.

"Many decision makers are too cozy with industry and are not concerned enough about public health," she said. The problem of members of Congress pressuring the agency to grease the path for a favored company is particularly onerous when it comes to firms making medical devices as opposed to medications.

"There are only a dozen or so major pharmaceutical companies, and a lot of them are based in New Jersey," Dr. Zuckerman said. "But there are thousands of companies making medical devices, and they're in every congressional district. When some company doesn't like what the Center for Devices and Radiological Health is doing, they complain to their congressmen, who are very effective lobbyists."

FDA critics say one reason that the agency's priorities are skewed is the practice of charging pharmaceutical and medical device makers "user fees" to subsidize the approval process. By becoming too dependent on corporate dollars, it is argued, the FDA is prone to cater to corporate interests. User fees for pharmaceutical makers were instituted in 1992, and those for medical device companies in 2002.

It takes 2 or 3 years just to turn 10 degrees.

Although the case of Dr. Nicholas happened on the watch of FDA leaders appointed by President Obama, students of the agency say that it has made progress toward becoming a more open, patient-centered institution.

"My sense of the device center over the last 6 months is that there is an intense focus on making science-based decisions and resolving scientific differences of opinion in a thoughtful way," said cardiologist William Maisel, MD, director of the Medical Device Safety Institute in Boston, Massachusetts, and a consultant to the FDA. "There have been some marked changes and improvements. I don't think there's a hangover from the Bush administration."

Steven Findlay, a senior health policy analyst at Consumers Union (the publisher of Consumer Reports), told Medscape Medical News that the agency's reform movement began even before President Obama took office. "There were some enlightened actions by the agency to allow dissenting voices," he said.

Mr. Findlay noted that the agency's tilt toward drug and device makers began before George W. Bush became president. "The culture at the FDA has been problematic for many years," he said. "But it became more acute during the Bush administration," he noted. "The FDA leadership was perceived to be pretty friendly toward industry."

Like others, Mr. Findlay said the story of Dr. Nicholas illustrates how slow institutional transformation is.

"A new administration always encounters inertia and entrenched interests," he said. "You can shake up a bureaucracy by appointing new leaders, but you still have 99% of the old staff."

"It happens to every administration. It takes 2 or 3 years just to turn 10 degrees."

ACR Says Dr. Nicholas Has Conflict of Interest

Besides reopening the discussion about the faithfulness of the FDA to its mission, the testimony of Dr. Nicholas was the latest salvo in the battle over virtual colonoscopies and how they compare to optical colonoscopies.

A representative of the American College of Radiology (ACR) who was at the hearing told Medscape Medical News that Dr. Nicholas's stance on the diagnostic procedure was "unreasonable" and that, as a gastroenterologist, he has a conflict of interest.

"It's far better for him to recommend an optical screening," said E. Stephen Amis, MD, who cochairs the Joint Task Force on Adult Radiation Protection of the ACR and the Radiological Society of North America. Dr. Amis said that the risks of virtual colonoscopies are minimal for the benefits they provide, such as giving patients an option to the sedation and intrusive scoping of a colonoscopy.

"A lot of patients don't want to go through that," he said.

He noted that each virtual colonoscopy exposes a patient to about 5 millisieverts of radiation. If a person had 6 such procedures between the ages of 50 and 80 years — 1 every 5 years — the total radiation exposure would only be 30 millisieverts, said Dr. Amis. "That's not a huge dose. That's safe."

Dr. Amis said Dr. Nicholas was fighting a losing battle, particularly since radiologists are already using CT scanners for virtual colonoscopies even though the machines have not been officially approved for that use.

The FDA's Web site states that the agency "has never approved CT for screening any part of the body for any specific disease, let alone for screening the whole body when there are no specific symptoms of disease at all." Such scans are not the best way to screen for any disease or condition "at this time," the Web site notes, although there are trials under way to determine the procedure's effectiveness and, in particular, whether "CT virtual colonoscopy is as good as colonoscopy in men and women over 50."

Medscape Medical News attempted to interview Dr. Nicholas, but a spokesperson for the Scripps Clinic said he was "not at liberty to share any information you are requesting at this time."

For his part, Dr. Nissen at the Cleveland Clinic rejects the idea that the debate on virtual colonoscopies is a turf war between 2 specialties. "To call it that is to minimize the serious health concerns involved," he said, adding that he also worries about the growing use of CT scanners for angiograms.

"They're 5 to 7 times the dose of a traditional angiogram," Dr. Nissen said. "I've cautioned against this. It's getting out of control."


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