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mdi's Online Newsletter

mdi’s staff is constantly encountering issues, situations and problems that are not only unique to our clients but to the manufacturing industry as a whole.  When we see such an issue, and we feel it can provide some help for other companies, we will prepare an INSIGHT REPORT and publish it on this Web Site.

If you have any comments on these INSIGHTS we want you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would put them up on this site for others to learn from.


The Insight Report

Insight Report Vol. 13 No.1
“FDA Spying on its Own Scientists”

Prepared by: Aditya Sukthankar


Background:

A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show. What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.

Surveillance Operation and FDA’s stand :

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency. F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.

While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.

Spy Software:

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

Government Intervention and some Findings:

A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications. With the documents from the surveillance cataloged in 66 huge directories, many Congressional staff members regarded as sympathetic to the scientists each got their own files containing all their e-mails to or from the whistle-blowers. Drafts and final copies of letters the scientists sent to Mr. Obama about their safety concerns were also included.

Lawsuit filed by the scientists and FDA’s Defense:

In 2011, the scientists found that a few dozen of their e-mails had been intercepted by the agency. They filed a lawsuit over the issue in September, after four of the scientists had been let go, and The Washington Post first disclosed the monitoring in January. But the wide scope of the F.D.A. surveillance operation, its broad range of targets across Washington and the huge volume of computer information it generated were not previously known, even to some of the targets.

The F.D.A. defended the surveillance operation in a statement on Friday. The computer monitoring “was consistent with F.D.A. policy,” the agency said, and the e-mails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.” The statement did not explain the inclusion of Congressional officials, journalists and others referred to as “actors” who were in contact with the disaffected scientists.

FDA Stated its Purpose:

According to FDA in a second statement on Saturday night, Erica V. Jefferson, an F.D.A. spokeswoman, said that the agency did not monitor the computers of any nonemployees and did not look at the employees’ home computers. She said the purpose of the monitoring was not to interfere with whistle-blowing or to deter critics, but to determine whether proprietary information was being illegally sent by disgruntled employees to outsiders. The journalists, Congressional officials and others on the list of “collaborators” were possible recipients of such information, and their confidentiality is protected by law.

Consequences of the whole operation and disgruntling within the Scientists:

The administration officials were so concerned to learn of the F.D.A. operation that the White House Budget Office sent a government-wide memo last month emphasizing that while the internal monitoring of employee communications was allowed, it could not be used under the law to intimidate whistle-blowers. Any monitoring must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing,” the memo said.

Although some senior F.D.A. officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation.

But Stephen Kohn, a lawyer who represents six scientists who are suing the agency, said he planned to go to federal court this month seeking an injunction to stop any surveillance that may be continuing against the two medical researchers among the group who are still employed there.

The scientists who have been let go say in a lawsuit that their treatment was retaliation for reporting their claims of mismanagement and safety abuses in the F.D.A.’s medical reviews.

Conclusion:

The whole scenario depicts that there is no congruence within the agency and its own appointed officials. The fact that FDA is spying on its own scientists implies that the agency does not have trust in its own officials. It also makes a common man think that the fact that agency is spying on its own officials, the officials might also be guilty in some aspects. It can be concluded from all these findings and discoveries that may it be that between agency and its officials anybody can be guilty but finally it is at the stake of safety of public. Such practices if at all remain prevalent can be detrimental not only to safety of common public but also to the whole society. Hence a proper investigation should be made periodically and an eye should be kept on agency’s as also its officials’ activities.

Next Insight Report - to be announced. 

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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