What Happens to An FDA Whistle Blower

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

What Happens to An FDA Whistle Blower

PostPosted by DCNGA » Tue Jul 31, 2012 8:54 am

They are labeled 'caustic' and trouble makers and seen as traitors. I call them heroes. Dr. Smith has done what no one else has had the courage or 'guts' to do. I cheer his efforts:

WASHINGTON — As he often did, Dr. Robert C. Smith was hammering away at his bosses at the Food and Drug Administration in the most caustic of terms at a meeting to address his concerns about the approval of medical devices.

With seven fellow scientists seated behind him in support, Dr. Smith charged that managers “are not following the law, not following the science, not following F.D.A. core values,” according to notes of the 2008 session. He glared at a supervisor, who sat fuming in front of him.

Dr. Smith — radiologist, lawyer, litigant and the man now at the center of a spying scandal at the F.D.A. — is in some ways typical of that peculiar Washington phenomenon known as the whistle-blower: He pressed charges of government abuse, battled with his bosses, and ultimately was shown the door amid lawsuits and investigations.

But he took his role to an extreme, according to former colleagues, scorning negotiations, making enemies of critics and papering Washington with complaints, which helped sow chaos at the agency. One co-worker compared his efforts to “a mutiny.”

This month, F.D.A. officials came under fire from Congress after disclosures that they had begun a surveillance operation monitoring the e-mail of Dr. Smith and four other employees as they wrote to their lawyers, lawmakers and even President Obama. Dr. Smith’s scorched-earth tactics had so unnerved managers that they, too, resorted to extreme measures, and the monitors ended up producing a sort of enemies list of 21 agency critics, including Congressional officials, academics and journalists.

Some 80,000 pages of documents intercepted in the spy operation — many of them e-mails from Dr. Smith seeking help from scientists, politicians, reporters, academics and others — detail his campaign to expose what he claimed were harmful practices at the F.D.A. The documents, accidentally posted online by an F.D.A. contractor, reveal a four-year process of estrangement between Dr. Smith and his bosses.

At first, F.D.A. managers sought to appease him by restructuring his office, calling in mediators and pledging reforms. But he responded with more sweeping charges of wrongdoing, accusing agency officials and manufacturers of a criminal conspiracy to market unsafe devices. An outside consultant said his vitriolic attacks created a toxic workplace.

Dr. Smith stood to profit from his accusations: he and other disgruntled F.D.A. scientists had filed a lawsuit, kept secret under court seal by law, against manufacturers of imaging devices. After discovering the suit, F.D.A. officials began to suspect his motives. Those suspicions intensified when they learned that he had filed similar whistle-blowing lawsuits against two previous employers, Yale and Cornell.

The Brooklyn-born Dr. Smith, 52, who left the drug agency in 2010 and is now working as a radiologist at a private practice in Great Neck, N.Y., does not apologize for his aggressive style. “I’m not the kind of guy who ever in his life turns a blind eye to things,” he said in an interview.

His concerns about the effectiveness of certain imaging devices for detecting breast and colon cancer are shared by some medical experts. But potential allies were driven off by his abrasive style. “He got annoying, he got obstructive in nature,” said Dr. Carl D’Orsi, a mammography expert at Emory University who worked on an F.D.A. review panel and also served as a consultant for a manufacturer. Fellow employees went further, complaining to the consultant that Dr. Smith was “disruptive,” “adversarial” and “confrontational.”

Staff members for three Congressional committees that often criticize the F.D.A. reviewed Dr. Smith’s complaints and chose not to pursue them. The inspector general of the Department of Health and Human Services examined his claim that the agency was violating the law in reviewing medical devices and concluded that he was wrong.

Dr. Smith maintains that many imaging devices do not work as advertised by their manufacturers, produce many false positives and subject patients to needless rounds of potentially harmful radiological testing. Moreover, he says they waste enormous amounts of federal Medicare aid. Dr. Smith said that his sole goal in making his complaints was to protect Americans from harmful medical devices and that money was not a motive.

His concerns are now getting another look. The Office of Special Counsel, which investigates whistle-blower grievances, found in a confidential review this spring that Dr. Smith’s allegations raised a “substantial likelihood” of serious problems and required a full review. That has triggered an investigation by Kathleen Sebelius, the secretary of health and human services.

A graduate of Johns Hopkins University and Yale Medical School, Dr. Smith was a respected radiologist who set new standards for diagnosing kidney stones with groundbreaking research in the mid-1990s. Colleagues described him as both brilliant and bombastic, and he clashed with supervisors in his jobs on the medical faculties at Yale and Cornell.

He charged in lawsuits that both universities fraudulently billed Medicare for improper radiological services. The fraud claims were ultimately thrown out, but Dr. Smith won settlements believed to total several hundred thousand dollars over retaliation he said he endured for complaining.

Within two years of his joining the F.D.A. as a radiologist in 2006, relations began to turn acidic there as well, as he challenged the approval of more than a dozen imaging devices.

Meticulously organized, he would arm himself with reams of scientific data, internal e-mails, notes of conversations, and citations from F.D.A. policy manuals and health statutes to make his case. Often, his language would be peppered with legal phrases honed from his days at Fordham Law School, where he completed a degree shortly before joining the drug agency.

He and eight colleagues accused agency managers of being too closely aligned with the medical manufacturers they regulated. They became known as “the F.D.A. 9,” and Dr. Smith was clearly their leader.

In the lawsuit he and six of the supporters brought in 2009, which was later unsealed, Dr. Smith’s group essentially accused the F.D.A. and medical manufacturers of conspiring to approve faulty devices. They brought the multibillion-dollar suit under the False Claims Act, which allows whistle-blowers to collect up to 30 percent of any damages. They withdrew it last year after the Justice Department declined to support the case.

A month before the lawsuit was filed, an F.D.A. biomedical engineer named Paul T. Hardy wrote an e-mail to the group signaling both his displeasure with the agency and the prospect of large financial damages.

“They are all corrupt,” Mr. Hardy said of supervisors. “Just need to sue the hell out of the agency ... get a couple cool mill and get out.” (He was fired in 2011.)

When Dr. Smith and other medical reviewers began demanding that manufacturers provide them with more clinical data about the safety of their products, F.D.A. managers deemed the requests excessive. “Things were getting out of hand,” said Larry Kessler, a former top F.D.A. official. “The reviewers were setting the bar far too high.”

Dr. Smith repeatedly approached lawmakers, sending out batches of late-night e-mails with huge files attached to demonstrate the F.D.A.’s dysfunction. Some Congressional staff members thought the F.D.A. might be punishing him for raising complaints. But others found his confrontational tactics so off-putting that they chose not to work with him.

Meanwhile, F.D.A. officials themselves resorted to more aggressive tactics as the battles wore on. Four times, the agency went to the inspector general to seek a criminal inquiry into allegations that Dr. Smith illegally leaked confidential information, had a financial conflict or improperly recorded conversations. Each time, the inspector general turned the agency down.

Despite the setbacks, the F.D.A. moved ahead with its surveillance program in April 2010.

“I never imagined in my wildest dreams that they were watching us second by second on our computers,” Dr. Smith said.

Three months after the surveillance began, a supervisor approached Dr. Smith in an F.D.A. library and told him he was being placed on administrative leave for improperly downloading documents and would be let go at the end of his two-year contract.

Dr. Smith sent his allies one last e-mail as an F.D.A. employee.

Captured in the surveillance files, it read: “Just to let everyone know, 30 minutes ago I was placed on paid administrative leave and escorted from the building. I am not kidding around. Talk to you later.”

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: What Happens to An FDA Whistle Blower

PostPosted by DCNGA » Wed Aug 08, 2012 6:26 pm

And let's top this off.. the top brass KNEW these doctors were being monitored..

U.S. NEWSAugust 6, 2012, 10:45 p.m. ET
Top FDA Officials Were Aware of Email Monitoring
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Top Food and Drug Administration officials including Commissioner Margaret Hamburg knew about the monitoring of emails of scientists who had raised safety issues, according to FDA officials and a letter the agency sent to Senate investigators.

The monitoring of emails began in the spring of 2010, FDA officials said, after proprietary information about companies' medical devices was leaked to some media outlets. Several companies that had applications for FDA approval pending complained to Jeffrey Shuren, director of the FDA's medical-device center, about the disclosures, the officials said.

Drs. Hamburg and Shuren didn't respond to requests for comment.

Dr. Shuren didn't order the surveillance of the five scientists, but he touched it off by asking his No. 2 official in the device center, Ruth McKee, to look into what could be done to stop the leaks, FDA officials said.

Ms. McKee met with the then-chief information officer of the agency, Lori Davis, to see what could be done. Ms. Davis in turn requested the monitoring of the first of five scientists who ultimately were monitored, the people said.

These details also are included in a letter sent by the agency to Sen. Chuck Grassley (R., Iowa), who has been asking for further explanations from the FDA about how the email monitoring began. The letter says top officials, including Dr. Hamburg, were briefed "after the initiation of the monitoring," but did not give further details.

Lawmakers on both sides of the aisle have objected to the email monitoring, saying it could have a chilling effect on agency officials who might need to report safety issues to Congress.

Sen. Grassley said his staff has asked to interview FDA officials but the agency hasn't made witnesses available. "The FDA's treatment of these whistleblowers deserves full scrutiny and answers," he said.

The five scientists under email surveillance were among a group of nine whistle-blowers who complained in early 2009 to then President-elect Barack Obama's transition team that safety issues were being overlooked by the FDA.

The FDA generally has defended the practice of monitoring emails by saying that it has a legal obligation to protect the proprietary information of companies seeking the agency's approval for their medical devices.

Ms. McKee didn't respond to requests for comment, and Ms. Davis couldn't immediately be reached. FDA officials said others in government were also informed of the monitoring, including officials and lawyers at the Department of Health and Human Services.

In recent weeks, an FDA team headed by John M. Taylor III, counselor to Dr. Hamburg, has conducted an internal investigation to find out how the monitoring program was authorized.

In addition to Drs. Hamburg and Shuren, the then-general counsel of the FDA, Ralph Tyler, also was briefed on the monitoring program, according to people familiar with the matter. Mr. Tyler declined to comment. FDA officials said that neither Dr. Hamburg nor Mr. Tyler objected to the surveillance effort.

The email monitoring began by focusing on one vocal scientist, Robert C. Smith, medical officer in the radiological-devices branch of the FDA's medical device center. Soon after, additional information was gleaned from the surveillance that led the agency to monitor four other scientists, the people said.

Some FDA officials have criticized Dr. Smith, saying he brought work to a standstill in the radiological-devices branch by not approving certain devices during his tenure.

Dr. Smith's lawyer, Stephen Kohn, said that several other scientists in the FDA supported Dr. Smith's views.

Even some sympathetic to the agency have questioned the monitoring program.

"This is where administrators get tested if they're not well-schooled in whistleblower law," said David Kessler, FDA commissioner under both Presidents George H.W. Bush and Bill Clinton.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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