Sad & Pathetic FDA Scandal

[Harrison]

The FDA is protecting itself -- instead of us? Read the second to last paragraph. Unbelievable. Hey whistleblowers, here's an idea: just use your own computers or smartphones to alert people outside the FDA bubble!
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Whistleblowers Sue FDA, Claim Emails Monitored
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: January 31, 2012

WASHINGTON -- Six former FDA scientists are suing the agency, saying it unlawfully monitored personal email accounts from their work computers after the scientists complained to Congress about allegedly unsafe medical devices gaining approval.

According to the Washington Post, scientists and doctors within the Center for Devices and Radiological Health (CDRH) first made internal complaints starting in 2007 that the agency had approved or was close to approving at least a dozen radiological devices that had not been shown to work and may have posed risks to patients.

The lawsuit, which was filed in the U.S. District Court for the District of Columbia last week, notes that in 2008 an FDA scientist wrote a letter to Congress with allegations that senior managers at the FDA's CDRH "ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions, and recommendations in violation of the law."

FDA officials became aware of that letter when a high-ranking member of Congress sent a letter to FDA officials outlining the allegations.

In early 2009, nine FDA scientists sent another letter, this one to President Obama's transition team, alleging "corruption within the FDA device review process, managerial misconduct, dangers to public health, welfare and safety, and retaliation against whistle-blowers."

FDA higher-ups also learned of that letter, began to refer to the scientists as the "FDA Nine," and started to secretly monitor their work computers via spyware software for emails and other communications relating to their whistle-blowing activities, according to the lawsuit.

Around that time, Sen. Charles Grassley (R-Iowa) told FDA Commissioner Andrew Von Eschenbach, MD, that "FDA employees have a right to talk to Congress without interference and/or threats from the Agency ... [and] they have a right to talk to Congress confidentially," according to the lawsuit.

In a recent statement, Grassley said, "It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress."

He added that the FDA "appears to have persisted in a long campaign to punish a group of employees for talking to Congress ... I've seen this kind of behavior from the FDA before, and it's troubling to think there might be a pattern."

The staffers were all eventually fired from their positions in the CDRH, according to the lawsuit, mostly by not having their contracts renewed when they expired.

FDA computers post a warning when users log on alerting them that they should have "no reasonable expectation of privacy regarding any communication or data passing through or stored on the system" and that the government may intercept any of the data at any time.

Lawyers for the FDA scientists, however, argue that the scientists were told by the FDA that they could use their computers for personal purposes, and thus they had a "reasonable expectation of privacy." (The email communications about whistle-blowing activities were via the scientists' private Gmail or Yahoo accounts.)

The FDA staffers are accusing the FDA of violating their Fourth Amendment rights, which protect against illegal searches and seizures, and their Fifth Amendment rights, which protect against abuse of government authority. Collecting emails to use against the scientists created a "chilling effect" on free speech, so the FDA also is guilty of violating their First Amendment rights, lawyers for the plaintiffs argued.

According to the lawsuit, the FDA twice attempted to have the employees criminally investigated by HHS' investigatory arm -- the Office of the Inspector General (OIG). OIG responded that "the referral lacks any evidence of criminal conduct on the part of any HHS employee," adding that a federal whistle-blower law protects the types of disclosures they made. The Department of Justice also allegedly turned down a request to investigate the scientists for wrongdoing.

The lawsuit doesn't detail all of the devices that were of concern to the scientists, but the Washington Post reported that three of the devices were for detecting signs of breast cancer; several were were screening for colon cancer; one was meant to detect osteoporosis; and another was for monitoring pregnant women in labor.

One of the FDA scientists reviewed a CT colonography device and concluded the device wasn't effective or safe and emitted so much radiation that a single exam with the device would be equal to receiving 800 chest x-rays.

The plaintiffs are seeking a judgment that the U.S. government cannot search employees' private email without "due process" and cannot target whistle-blowers without search warrants.

The FDA does not comment on ongoing litigation, according to an FDA spokeswoman.