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Strong Justice For Serious Injuries

FDA Caught Red-Handed Spying On Its Employees

On Behalf of | Sep 23, 2018 | Articles

An investigation by the Food and Drug Administration of a number of its employees, characterized as an effort to quell their communication with outside critics of the agency, particularly in the matter of medical review procedures, was the topic of a recent New York Times article.

In that article, reporters Eric Lichtblau and Scott Shane wrote that an initial review by the FDA of a small group of seemingly dissident scientists in its ranks in 2010 was expanded into a probe of several others within the agency. According to one agency memorandum, these employees were collaborating with non-FDA medical researchers, lawyers, journalists and Congressional members and aides, to conduct a campaign of defamation. FDA officials said they had no intention of impeding employees’ communications but were merely trying to determine if intelligence was being shared improperly.

Agency scientists and officials have maintained a years-long dispute about review procedures that the scientists have deemed faulty. Scientists assert that questionable reviews have resulted in grants of approval for medical imaging devices used in mammograms and colonoscopies, thereby exposing patients to perilous levels of radiation.

The Times report said the FDA used “spy” software initially to obtain screen images from the laptops of five agency scientists working in their offices and at home. Keystrokes were tracked, personal email intercepted, documents copied from the scientists’ flash drives and personal messages read as they were being drafted, Lichtblau and Shane said.

Wider surveillance yielded letters to Congressional offices and oversight committees, legal filing drafts and emails back and forth. The operation was handled by a private contractor hired by the FDA, which evidently blundered when it later posted much of the material on a public Web site, a move that, among other things, allowed the Times to review it closely and at length. The site was taken down in July, a day before the article was published.

A January 2011 article in the Washington Post first revealed the monitoring program. Current and former FDA scientists filed a lawsuit against the agency in September 2011, when they discovered that dozens of their emails had been intercepted and four of those scientists had been dismissed. With implications of the wide range of the FDA’s surveillance program quickly transpiring, the FDA issued a memo explaining that the original five scientists’ emails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.” The agency further insisted that while the Congressional recipients of the emails and those it called other “actors” were in league with the scientists to generate negative publicity, they were never FDA surveillance targets, even though they were suspected of having received confidential information.

The Times article said that even with federal agencies’ power to monitor employees’ computer use, the FDA might have behaved illegally by seizing confidential information protected by law—which would include attorney-client exchanges, complaints to Congress by “whistle-blowers” and workplace grievances filed with the
Government. Expressing its concern about the situation, the White House Office of Management and Budget issued a memo this past June that deferred to the agency’s power of internal monitoring but deplored any attempt to intimidate whistle-blowers or otherwise interfere with “employees’ use of appropriate channels to disclose wrongdoing.”

Dismissed FDA scientists allege in one of the lawsuits that intimidation and interference were exactly what the FDA practiced in retaliation to the criticisms they made about the agency; particularly about its medical reviews. The Times article said that Stephen Kohn, the attorney representing six scientists who are suing the FDA, was seeking an injunction in federal court to end any surveillance that might be conducted against two medical researchers still in the agency’s employ. Within the documents that have already been made public there is no indication either that the FDA surveillance program is still going on or has been discontinued.

The Times could and did refer to a case and an article that might have led the FDA to initiate its surveillance program. In March 2010, the paper published an article revealing the concerns of two FDA scientists about the safety of two imaging devices submitted to the agency by GE Healthcare for approval. The two scientists, Dr. Robert C. Smith and Dr. Julian Nicholas, were later the subject of heavy surveillance, and Dr. Smith was identified in an agency memo as a “point man” for disgruntled scientists, since he wrote hundreds of emails advising them how to make their complaints known.

Attorneys for GE Healthcare said the Times article included proprietary information about the imaging devices, which may have been leaked to the press. The writer of the article, Gardiner Harris, later showed up high on the list of “media outlet actors” compiled by the FDA’s surveillance program monitors. FDA officials went to the Department of Health and Human Services, hoping to get its Inspector General to seek a criminal investigation of that alleged leak. The IG turned them down, saying there was no evidence of a crime and that “matters of public safety” are legal material for the media. That setback probably led to initiation of the surveillance program.

Dr. Smith’s “point man” status soon did him in. That same year, 2010, FDA monitors read emails that said several agency scientists were drafting a complaint they were going to take to the Office of Special Counsel. Before they could, Dr. Smith and another scientist were dismissed and a third person was suspended. At another time, the captured emails indicated that Paul T. Hardy, formerly a dissident employee but by then no longer with the FDA, had reapplied for a job there. He was described as “being considered for a position,” but he did not get it. Among the items pulled from his emails was one about possibly getting in contact with the people from Frontline, the Public Broadcasting System’s documentary program.

When the whole surveillance presentation was mistakenly put on a public Web site, it first of all defeated the efforts of GE Healthcare and other companies to keep proprietary information secret, since such information was extensively discussed in the myriad documents created by both the insurgent employees and the defense-minded.

Eventually, perhaps inevitably, it led to the employees’ discovery of the site. A researcher, making Google searches for the involved scientists, was tracking instances of negative publicity that might impinge on their chances of finding post-FDA employment. Soon, like Balboa beholding the Pacific, he was looking at the agency’s surveillance program.

“I couldn’t believe what I was seeing,” he told the Times, while requesting anonymity because of his own job search. “I thought,” ‘Oh my God, everything is out there. It’s all about us.’ It was just outrageous.”