End the Lie

FDA sued for allegedly spying on whistleblowers’ personal e-mails

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By End the Lie

Current as well as former employees of the United States Food and Drug Administration (FDA) have accused the FDA of spying on their private e-mail conversations after they had made an attempt at blowing the whistle on corrupt practices within the agency.

These individuals, all of which are either doctors or scientists, said that the FDA was approving medical devices that actually presented a health risk to patients or were otherwise ineffective, despite the testimony of experts.

They have now filed an official complain in the U.S. District Court in Washington, D.C., and are seeking an injunction which would immediately halt the surveillance, according to a recent article published by The Washington Post.

The plaintiffs in the case allege that the FDA was spying on their personal e-mail conversations that were transmitted via their private Gmail accounts and that the agency was using automated software to take screenshots of their computer activity, “showing documents as they were being backed up and e-mails being moved from one file to another.”

The FDA then created a file dubbed “FDA 9” to store the data gathered from nine scientists and doctors. Three of those nine targeted by the agency are not participating in the lawsuit, which was filed last week, for reasons which are not yet clear.

However, these individuals did access their accounts from government-owned computers and apparently employee computers at the FDA display a warning upon booting up which warns users that they have “no reasonable expectation of privacy.”

The warning applies to all data which passes through or is stored on the computer, and it also apparently states that the government has the ability to intercept data on the computer whenever they want, for any lawful government purpose.

Yet the employees who filed the complaint still say that the agency was in violation of their constitutionally-protected rights by actively monitoring their personal e-mail accounts. They also claim that their conversations with Congressmen were legally protected from surveillance.

All of the individuals involved in the suit were working for the FDA’s Office of Device Evaluation, during which time they expressed concern over radiological devices soon to be approved by the FDA to both journalists and individuals in Congress.

It was not just the media and Congress who were contacted by these concerned individuals, indeed they also brought the information to the White House and the Department of Health and Human Services (HHS) inspector general.

They were worried that the FDA would approve the device in question (just one of at least a dozen radiological devices with unproven effectiveness and possible health risks), even though they had evidence that the devices actually missed signs of breast cancer during the course of their testing.

In fact, three devices in total risked missing signs of breast cancer in patients while another had the possibility of erroneously diagnosing osteoporosis which would result in unnecessary and costly treatments for otherwise healthy patients.

In addition to the breast cancer screening device, they were troubled by an ultrasound device which allegedly had the capability to malfunction when monitoring pregnant women who were in labor. Such malfunctions have the danger of harming the fetus.

They also said that colon cancer screening devices could actually give cancer to healthy patients due to excess doses of radiation delivered by the device.

These are all hardly small issues which can be brushed aside with ease and the fact that the FDA would actually go after doctors and scientists for attempting to protect the public from dangerous medical devices is downright disturbing.

Even though a team of experts recommended that the breast cancer screening device not be approved a whopping three times, along with mid-level managers who agreed with their conclusions, it was approved by a senior manager in 2008.

The complaints go back to 2007, at which time they were purely internal complaints, but since the FDA clearly had no interest in actually protecting public health, they were ignored.

While the FDA’s spokesperson Erica Jefferson has said that the agency will not comment on active litigation, there is a history of the FDA attempting to stifle these concerned scientists and doctors going back to at least May of 2010.

It seems pretty clear to me that these attempts at having these individuals investigated were aimed at trying to get the doctors and scientists to stop revealing the truth, although clearly it did not work out as they had hoped.

According to internal FDA documents which the individuals in question obtained through a Freedom of Information Act (FOIA) request, the agency alleged that the doctors and scientists had improperly disclosed business information about the devices and attempted to have an investigation opened in May of 2010 by the inspector general of the Department of Health and Human Services.

Of course, the scientists and doctors involved denied the accusations of improper sharing of confidential information and the inspector general decided not to pursue an investigation as requested by the agency as they found no evidence of criminal conduct whatsoever.

Furthermore, the HHS inspector general’s office stated that the doctors and scientists indeed had a legal right to relay their concerns to individuals in Congress or journalists.

Later that year, the agency went after them again, with the director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, writing, “We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” in June of 2010.

Once again the inspector general’s office turned down the agency’s request, even after speaking with federal prosecutors.

Senator Charles Grassley seems to be as outraged by this as I am, although it remains to be seen if he will actually do anything about it or just let this type of corruption continue unabated like so many other government officials do.

“The FDA has a huge responsibility to protect public health and safety,” Senator Grassley, an Iowa Republican, said in a statement he released last week.

“It’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress,” Grassley added.

One of the six employees who filed the complaint was fired in November after a negative performance review which an internal FDA document said was because managers said they did not “trust” him while two others did not have their contracts renewed, two were harassed and passed over for promotions and the last one was fired outright.

The fact that people can be targeted for trying to do their job well and protect the American people from a corrupt bureaucracy that is approving dangerous devices is nothing short of astonishing. At the very least we can say that these brave scientists and doctors are somewhat lucky that the Obama administration didn’t go after them even harder than the FDA, like the CIA whistleblower who revealed that the United States was torturing alleged terrorists.

Hopefully Senator Grassley and others will actually do their jobs as well and make sure this kind of thing can never happen again.

One Response to FDA sued for allegedly spying on whistleblowers’ personal e-mails

  1. Mark January 31, 2012 at 3:20 PM

    This is what you get in the NAZI state — try to help people and get targeted


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