Spying on Employees - The FDA Attempts To Suppress Questions About Safety

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The Food and Drug Administration, long believed to be the last stop in determining the safety of food and drugs marketed to the public, has become an icon of corruption and greed marked by sloppy efforts to only appear trustworthy. Scandals have rocked the federal agency since the 1950's, escalating in frequency and morphing into the mass of thieves, liars, and murderers of today. It has essentially become nothing more than a legally organized crime mob whose members' sole purposes are to line their pockets with greenbacks while turning a blind eye to the blood of innocents spilled.

Since the Freedom of Information Act was passed, scrutiny has produced more and more evidence of extreme corruption at very high levels within the federal agency. Since the 1980's when Donald Rumsfeld and the Reagan Administration manipulated the FDA in the push to approve the imitation sweetener aspartame, followed by the generic drug scandal of 1989, the number of scandals have grown. The FDA of today does very little to protect the American public from harmful drugs or food. They have approved thousands of food additives and preservatives known to cause illness and disease. They have ignored or hidden studies proving that statin drugs do nothing other than cost patients thousands of dollars while causing irreversible damage. They have refused to inform the consumers of potential hazards associated with specific drugs and have fostered phoney beliefs designed to rape the consumer's bank account. They have cast their lot with the very companies they are supposed to be protecting us against.


"User Fees" create a business relationship with pharmaceutical companies

An agency that was once the first consumer protection agency has become an organization occupied with kowtowing to pharmaceutical companies. Instead of being fully funded by the federal government, it has become business as usual in collecting “user fees” from drug and medical device companies. $524,362,000 was collected during fiscal year 2008. With this kind of cash flowing into the agency, it's no wonder it treats pharmaceutical companies like fee-paying customers. The law authorizing such fees is up for renewal this year. One former official at the FDA, Janet Woodcock believes such a law creates a “sweatshop mentality,” as she was quoted in 2006.

The FDA has been known to remain silent about public health safety issues

A New York Times article published in 2009 revealed that the FDA isn't forthcoming about information which raises safety questions in regard to individual drugs or devices being reviewed. They have been known to remain silent about discoveries like increased heart attack risks, possible liver damage, or suicidal thoughts being due to a product. Their reason? The robotic answer is always about their duty to guard the corporation's trade secrets.

FDA Officials Investigate "Whistle-blowers"

The latest and perhaps most disturbing scandal involving the FDA, hit the news a couple of days ago 7/14/2012). There are those who don't like the negative feedback about the “drug approval for personal gain” activities rife in the agency. Rather than investigate the many claims and charges brought by scientists and consumers regarding corruption, officials in the agency chose to investigate the whistle-blowers by launching a wide ranging surveillance operation against their own scientists. Using a targeted enemies list, the agency intercepted thousands of private emails sent by concerned scientists to labor officials, journalists, lawyers, members of Congress and even the President.

Surveillance identified 21 "targets" including Congressional officials and journalists

The FDA claims their actions were over concern regarding the possible leaking of agency information by five scientists in their employ. However, according to more than 80,000 pages of computer documents, around the middle of 2010, the operation grew in an effort to discover who was behind the negative PR regarding the medical review process used by the FDA. In a move to silence the collaboration between opponents of the FDA, the surveillance identified 21 employees and several Congressional officials. Journalists and medical researchers outside of the agency were also targeted for their possible collaboration in spreading negative and “defamatory” information about the administration.

Officials at the FDA claimed the computer monitoring was only limited to the five scientists they believed to be guilty of leaking confidential information about the design of certain medical devices as well as their safety. And while they admit surveillance of communications between scientists and journalists, Congressional officials and attorneys, they claim their intention was not to hinder them in their communications efforts, but to ascertain if the information being shared was appropriate.

During the efforts exerted in surveillance, screen images were captured from the computers of the five scientists in question both at home and at work. Using spy software commonly used by many businesses and employers who monitor employees' use of company computers, they intercepted personal emails, and followed personal messages even as they were being constructed. Their personal thumb drives were not safe either. The FDA also copied document files from such drives and tracked keystrokes.

Why did the FDA go to such extraordinary measures?

For several years, scientists at the FDA had been feuding with their supervisors over claims that faulty review procedures led to premature approval for certain medical imaging devices related to mammograms and colonoscopies. The scientists' concern was the unnecessary over exposure to dangerous levels of radiation. Then just this past May the Office of Special Counsel believed the claims made by the scientists was convincing enough to launch a full investigation. The confidential review reasoned that “a substantial and specific danger to public safety” raised questions needing to be answered.

After discovering that a couple dozen of their emails had been hijacked by the FDA, the scientists filed a lawsuit last September, following the dismissal of four scientists. It wasn't until January that the spying behavior was outed by the Washington Post. At that time, it was still unknown just how wide the scope of surveillance or targets being monitored.

It wasn't until one of the dismissed scientists accidentally discovered the deception that the enormity of the scope was known. The researcher, was doing Google searches for others involved with the issue in an effort to check for any negative publicity that might impede career opportunities. What he discovered was shocking.

Documents captured during the surveillance included drafts of legal filings and grievances, confidential letters to oversight committees and Congressional offices, and personal emails. A company contracted by the FDA for the purpose of document-handling had made a grave mistake and posted all the absconded documents on a public Website, cataloged in 66 directories. Several Congressional staffers considered sympathetic to the scientists' cause, received their own files which held all emails to and from the researchers. Letters sent to President Obama regarding safety concerns were also a part of the public record.


FDA memo outlines "hit list" of scientists and collaborators

FDA officials, while acknowledging their surveillance of everyone, claims that they didn't do so as an act intended to obstruct communications. They insist their only concern was whether information was being illegally shared. Officials also claim that communications monitoring was done “without regard to the identity of the individuals with whom the user may have been corresponding.” And even though a memo described all individuals as “actors” who were collaborating with the scientists' to create negative publicity, officials claim that all those outside of the agency's employ were never targets of the operation. The FDA says they simply suspected the other players of receiving confidential information.

That may be their story and they're sticking to it, but there are laws in effect which may prove they've crossed the line. It's not unusual for employers to monitor the computer activities of their employees, and federal agencies have broad discretion in doing so, but snatching confidential information such as attorney-client communications doesn't fall under protection of the law, nor does tampering with whistle-blower complaints to Congress or grievances filed with the government.

What would you like to see happen to the FDA in the future?

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Presidential communications were monitored

One would question why the FDA would create a “hit list” if they were only concerned about specific scientists spilling trade secrets of the corporations who had applied to have their products reviewed. Why would they include Congressional offices, staffers, and even communications to the President of the United States?

Representative Chris Van Hollen is a Maryland Democrat involved with reviewing medical review procedures utilized by the FDA. He was number 14 on the list and one of his aides was number 13. A former staffer with Senator Charles E. Grassley, R-IA, also had emails cataloged in the database. Grassley charged the FDA with trying to be the Gestapo.

FDA confiscated 100's of emails from whistle-blowing scientists

The surveillance was a response to issues raised by Dr. Roert C. Smith and Dr. Julian Nicholas regarding their concerns over medical imaging devices. A memo from the FDA referred to Dr. Smith as the “point man”. In retaliation for the doctor making his concerns known publicly, they confiscated hundreds of emails written by him on ways others could get a willing ear for their own concerns.

As a result of the March 2010 article about the safety issues, reporter Gardiner Harris was the first to be placed on the hit list of “media outlet actors”. Attorneys representing GE Healthcare charged that proprietary information was improperly leaked, but when FDA officials sought a criminal investigation, the inspector general of the Department of Health and Human services declined. He found no crime because “matters of public safety” can legally be released to the media. The refusal to investigate led the FDA's spying activities.

As emails and documents were intercepted they were analyzed in a search for other “actors”. It was in this way that they discovered several scientists were drafting a complaint to the Office of Special Counsel. Before the complaint could be filed, they fired Dr. Smith and another scientist, and chose to suspend a third.

The six current and former FDA scientists and doctors who filed the January lawsuit have charged the administration with attempting to crush warnings of corruption by retaliation due to them passing information on to Congress and the media.

Which explanation do you believe...the one about the concern over improper disbursement of trade secrets or do you believe the FDA was trying to coverup corrupt activities within the agency?

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Comments 2 comments

fpherj48 profile image

fpherj48 4 years ago from Beautiful Upstate New York

Terry.......If "WE" do not continue to be informed and educated in terms of ALL government Agencies and their "activities," we are as good as doomed toward destruction. No product or company or service should EVER be over seen, advertised and/or "reviewed" by a single person associated wit it, in any way!!.

Thank you for this valuable Hub!! UP+++


Terri Meredith profile image

Terri Meredith 4 years ago from Pennsylvania Author

You sure got that right! It's like having the fox guard the chicken coop. I swear I don't know what we're thinking when we, as a country, allow all the doors to corruption and graft to be opened in this way. It boggles the mind when we consider the absolute conflicts within this flawed type of logic. Thanks, as always, for taking time to read and comment!

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