# Professionalism/The FDA Nine

The FDA Nine

## Introduction

From 2004 to 2008, corruption at the FDA, particularly in the 501(k) clearance process, was rampant. In response, nine FDA scientists wrote letters to Congress expressing their concerns about the device approval process, describing instances of scientists being pressured by upper management to approve unsafe devices at the CDRH. This led to several investigations into the FDA and two government accountability office reports. The FDA also conducted a massive surveillance program of several of its scientists that it believed were responsible for writing the letters. Several scientists were harassed or fired as a result, and outside journalists and congressional officials were also caught up in the surveillance program. The FDA faced a great deal of backlash as a result, and this scandal has led to increased protections for whistleblowers. Unfortunately, cases like this one happen all too often, and whistleblowers are often punished for speaking out against wrongdoing in their organizations.

## Corruption at the FDA

In 2004, a biopharma group, ReGen, submitted an application to the Food and Drug Administration (FDA) for 510(k) status on their product, Menaflex. Menaflex is a c-shaped piece of rubber intended to repair torn menisci. From 2004-2008 Menaflex failed to obtain 501(k) status twice as the FDA review board claimed that there was not sufficient prior art to demonstrate the safety of the device. In response to the second rejection, ReGen contacted three members of Congress: Senators Frank Lautenberg and Robert Menendez, and Representative Steve Rothman. These Congress members then spoke with the head of the FDA at the time, Andrew von Eschenbach. Eschenbach agreed to meet with ReGen, who convinced him to appoint the head of the Center for Devices and Radiological Health (CDRH) at the time, Daniel Schultz, as head of the investigation for Menaflex. When Menaflex failed again, Daniel Schultz created a completely new board of reviewers at the recommendation of ReGen. On the new board, no one from prior reviews was allowed to participate, and there were sports medicine doctors involved who had personal reasons for wanting the device on the market. Menaflex ultimately passed and received 510(k) status.
In 2007, scientists at the FDA began to complain about the device approval process. Specifically, these scientists were concerned about several radiological devices whose effectiveness was unproven. For example, three of these devices often gave false negatives when screening for breast cancer, and another device falsely diagnosed osteoporosis. Another ultrasound device could potentially malfunction while monitoring women in labor. In addition, another device intended to screen for colon cancer emitted radiation levels high enough to potentially cause cancer in healthy individuals.
In 2009 the US Government Accountability Office (GAO) recommended that the FDA take steps to ensure that the device approval process was based solely on science. Specifically, the US GAO recommended that the FDA analyze its 510(k) process, claiming that it was too easy for some products to get premarket approval. The GAO conducted a followup investigation in 2011 to determine the FDA's progress with the recommended changes. The committee found that while preliminary steps had been taken to amend the 510(k) process, there were still some areas that could be improved upon. For example, there were still 26 types of high-risk devices which could pass through the more relaxed 510(k) process. Among these devices were automated external defibrillators and implantable hip joints. The committee also took issue with the recall process at the FDA. While the FDA maintained extensive recall data, they did not review their recalls. The committee claimed that if the FDA analyzed recall data for high-risk devices, they could predict future recalls more accurately.

## Whistleblowing
##### FDA Nine

In response to the perceived corruption at the FDA, scientists at the FDA began to complain to upper management. However, this strategy was not effective. So, in 2008, nine of these FDA scientists began to correspond with Senator John Dingell over email to advocate for a formal investigation of the FDA. The scientists also began to send letters to then President-elect Barack Obama. In one of the original letters to John Dingell, sent on October 14, 2008, the scientists claimed that leaders at the CDRH "ha[d] ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law." They also stated that the criteria for determining the safety and efficacy of medical devices were deeply flawed. When these faulty safety determination methods were used once, CDRH officials would allow these procedures to become a precedent for later device approvals. In the letters sent to Barack Obama in 2009, the FDA scientists also alleged that the FDA had performed a sham investigation following several complaints about the device review process, and claimed that the scientists who complained of corruption were being retaliated against.

##### Robert Smith

The FDA Nine were lead by Dr. Robert Smith. Smith was ethically very professional; he was an established whistleblower who raised concerns at Yale in his previous job. As typically happens with whistleblowers, those against whom the whistle is blown seek to discredit and destroy the whistleblowers. Smith was instrumental in bringing the FDA scientists' concerns out of the FDA and to Congress and the White House. While this was ethically motivated, it may have also been because the whistleblowers believed that there was no chance of effecting change from within the FDA. In response to bringing their concerns to government officials outside the Agency, FDA's managers abused the power of the Federal government and began a far-reaching illegal surveillance program intended to dig up dirt on the whistleblowers and provide evidence of criminal activity. Following a 2-year investigation by the Committee on Oversight and Government reform, it was determined that it was FDA who engaged in illegal activity and not any of the whistleblowers. The Committee report (see https://oversight.house.gov/wp-content/uploads/2014/02/FDA-Staff-Report-final.pdf; also see https://www.gpo.gov/fdsys/pkg/CHRG-113hhrg87176/pdf/CHRG-113hhrg87176.pdf) made the following findings:
"CDRH scientists and doctors raised concerns to Congress, the OSC, and President Obama’s transition team about pressure from management to approve medical devices they believed were unsafe.
Despite the extensive scope of the monitoring, there was insufficient written authorization, no monitoring policy in place, and there was no legal guidance given to the contractors who conducted the monitoring. The lack of any legal guidance to limit the monitoring program resulted in FDA capturing protected communications.
Although FDA claimed to be investigating a specific leak of 510(k) information, the computer monitoring did not include a retrospective inquiry into any of the scientists’ network activities. When interviewed, FDA managers and IT professionals failed to explain clearly how the rationale offered to justify the monitoring (investigating a past leak) was consistent with the method used (monitoring current activity). The goal of monitoring was allegedly to identify who leaked confidential information. Instead of looking back at previous communications using available tools in their possession, however, the FDA chose real-time monitoring of current and future communications. Because FDA managers lacked formal investigative training and did not understand the legal concerns related to employee monitoring, they believed all employee communications that occurred on government computers were “fair game.”
Because FDA managers lacked formal investigative training and legal guidance, they did not understand the legal limits of permissible employee monitoring. As a result, the scope was limited only by the FDA’s technical capabilities. For example, those conducting the monitoring said they believed all employee activity having any remote nexus to government computers was “fair game”—even to the point of forensically recovering deleted files from personal storage devices when plugged into FDA computers. Moreover, the monitoring software collected all keystrokes on the computers, including the passwords for personal email accounts and online banking applications, even though de minimis personal use is permitted.
The monitoring program began when a law firm representing a manufacturer alleged unlawful disclosures were made to the press regarding a device that was under FDA review. Ruth McKee first ordered monitoring on Dr. Smith’s computer because Dr. Smith was believed to be the source of the leak. Later, monitoring expanded to include four additional CDRH scientists. Officials used Spector 360, a software package that recorded user activity with powerful capture and analysis functions, including real-time surveillance and keystroke logging.
The FDA’s surveillance was not lawful, to the extent that it monitored communications with Congress and the Office of Special Counsel. Federal law protects disclosures to OSC and Congress.
HHS OIG denied FDA’s repeated requests for an OIG investigation into the allegedly wrongful disclosures. OIG found no evidence of criminal conduct on the part of any employee. Still, officials continued to contact OIG to request an investigation. OIG again denied the request, and the Justice Department declined to take action.
The monitoring program ultimately failed to identify who leaked information to the New York Times or the Wall Street Journal, despite capturing approximately 80,000 documents and inadvertently publishing those documents on the Internet.
Despite known complaints about performance issues regarding Dr. Robert Smith, FDA management and leadership chose to address Dr. Smith’s employment status through repeated requests for criminal investigation, rather than by simply taking administrative or managerial actions directly within its own control and authority.
Over a year after receiving directives from OMB, OSC, and the FDA Commissioner, the FDA produced interim guidelines on monitoring procedures in September 2013. The FDA’s interim policies require written authorization prior to initiating employee monitoring. Only the Commissioner, Deputy Commissioner, or the Chief Operating Officer can authorize surveillance of employees. The FDA has not yet implemented permanent policies to govern employee monitoring.
The FDA’s interim policies do not provide safeguards to protect whistleblowers from retaliation. Under these policies, protected communications are still subject to monitoring and may be viewed by agency officials."

## FDA Surveillance Program
##### Motivation for Surveillance

After the nine FDA scientists, led by Robert Smith, wrote a letter to President-elect Obama in 2009 about alleged corruption and approval of unsafe devices within the FDA, the story was also covered by several news organizations. In 2010, Gardiner Harris wrote an article in The New York Times about a colon cancer screening device that had been submitted to the FDA for approval by GE Healthcare. Robert Smith and other FDA scientists believed the device posed serious health risks because it emitted high levels of radiation. GE lawyers expressed concerns that proprietary information about the device had been leaked by the FDA Nine to the media. Ken Ferry, the president of iCAD Inc., expressed similar concerns about a breast cancer screening device that was also called into question by the FDA Nine.
In response to these concerns about leaked confidential information, the FDA went to the Department of Health and Human Services to seek a criminal investigation against the FDA Nine. The inspector general found no evidence of a crime, since matters of public safety can legally be released to the media. The FDA then decided to begin a surveillance program of 21 people, including five of its own scientists that it believed to be involved in leaking confidential information, as well as congressional officials, outside medical researchers, and journalists.

##### Extent of Surveillance

The FDA created an "Actors List" where it listed the people it believed to be involved. The surveillance software the FDA used is sold by SpectorSoft and is sometimes used by employers to monitor employees. It is also marketed to parents to monitor their childrens’ internet use. The FDA used this software to intercept emails between FDA scientists and members of congress, lawyers, labor officials, journalists, and even President Obama. The software was also used to take screenshots of the scientists’ computer screens, obtain documents from their personal thumb drives, and follow their emails in real time as they were being drafted. Over 80,000 documents were captured.
In 2010, through reading these intercepted emails, the FDA discovered that a few of the scientists, including Robert Smith, were drafting a complaint to the Office of Special Counsel about corruption within the FDA. Before they could file the complaint, however, the FDA fired Robert Smith and another scientist, and put a third on probation. The FDA also discovered that Paul Hardy, another device reviewer, was talking to PBS about making a documentary on corruption within the FDA, and also intercepted an email from him to a congressional aide asking if he could get in legal trouble for what he was doing. Hardy was later fired.

##### Lawsuit Against the FDA

In 2011, the FDA scientists discovered they were under surveillance, and six of the original FDA Nine chose to pursue a lawsuit against the FDA. At this point, several had already been fired or put on probation. A story on the surveillance was published by The Washington Post in 2012. At this point, the full extent of the surveillance was still unknown to the scientists, until the information that was collected was accidentally leaked and posted on a website by a contractor to the FDA. The leak was discovered accidentally by one of the FDA scientists. It is unclear who at the FDA authorized the surveillance program, or whether it is still ongoing.

##### Congressional Officials Involved

Not only were the scientists outraged, but several of the congressmen who had been communication with the FDA Nine were also angry, since their communications were also being monitored. Charles Grassley, a Republican senator from Iowa, has been one of the most outspoken critics of the FDA’s surveillance program. Chris Van Hollen, a Democrat from Maryland who was listed on the FDA “Actors List” has also spoken out against the FDA.

## Outcomes

A 2013 House Oversight Committee hearing determined the FDA had acted outside of federal guidelines in its surveillance of its employees. Following the hearing, the Office of Special Counsel used the incident to implement new guidelines protecting government whistleblowers. The OSC and the hearing determined that surveillance of government employees is allowed, but that it cannot be used to intimidate whistleblowers.

## Conclusions
##### Culture at the FDA and Whistleblowing

This case shows the influence of an organization's culture on its workers, as well as the effects of trying to change it. The FDA's culture was a chain of trying to please bosses; the heads tried to please Congressmen, the managers tried to please the heads, and the scientists tried to please the managers. When the scientists found that pleasing their managers went against their professional integrity and tried to break this cycle, it resulted in an escalating scandal that even affected federal-level guidelines for whisteblowers. While these new guidelines are a step in the right direction, unless the structure of management and overall culture at organizations like the FDA is fundamentally altered, there will likely not be much change in how whistleblowers are treated.

##### Professionalism

The case of the FDA Nine reveals the conflicts between having a career and being a professional. Advancing a career requires one to please bosses, but being a professional requires one to satisfy their own sense of responsibility and integrity. When these two goals differ, one, the other, or both may suffer. The FDA Nine would not have been harassed or fired had they not spoken out. They hurt their careers by being professionals. This is a harsh lesson for professionals, since they can face adversity by prioritizing professionalism over career prospects. In fact, they may even lose their career. It is worth asking if a professional without a career is still a professional; that judgement is left to the reader.

## References

* 1 2 3 Mundy, A. (2009, Mar 6). Political Lobbying Drove FDA Process. The Wall Street Journal. https://www.wsj.com/articles/SB123629954783946701
* ↑ Harris, G. and Halbfinger, D.M. (2009, Sept 24). F.D.A. Reveals it Fell to a Push by Lawmakers. The New York Times. http://www.nytimes.com/2009/09/25/health/policy/25knee.html
* ↑ Goode, J.S. (2008, Aug 14). 510(k) Memorandum, Subject: ReGen Collagen Scaffold. Wall Street Journal. http://online.wsj.com/public/resources/documents/WSJ_510K_090303.pdf
* 1 2 3 4 5 Nakashima, E. and Rein, L. (2012, Jan 9). FDA Staffers Sue Agency Over Surveillance of Personal Email. The Washington Post. https://www.washingtonpost.com/world/national-security/fda-staffers-sue-agency-over-surveillance-of-personal-e-mail/2012/01/23/gIQAj34DbQ_story.html
* ↑ U.S Government Accountability Office. (2009, Jan 15). MEDICAL DEVICES: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. GAO. http://www.gao.gov/products/GAO-09-190
* ↑ U.S Government Accountability Office. (2011, Apr 13). MEDICAL DEVICES: FDA's Premarket Review and Postmarket Safety Efforts. GAO. http://www.gao.gov/products/GAO-11-556T
* 1 2 3 Hartford, J. (2013, June 12). The FDA Nine: 10 People Who Changed the Medtech Industry. Medical Device and Diagnostic Industry. http://www.mddionline.com/article/fda-nine-10-people-who-changed-medtech-industry
* 1 2 Phelps, J.R. and Karst, K.R. (2008, Nov 18). A Sign of the Times – FDA’s Medical Device Top Brass Under Fire From Within and From Capitol Hill. FDA Law Blog. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/11/a-sign-of-the-times-fdas-medical-device-top-brass-under-fire-from-within-and-from-capitol-hill.html
* ↑ Lichtblau, E. and Shane, S. (2012, July 30). Caustic Crusader at Center of F.D.A. Scandal. New York Times. http://www.nytimes.com/2012/07/31/us/dr-robert-smith-caustic-crusader-in-fda-spying-scandal.html
* ↑ Schiavone, L. (2009, Jan 9). FDA Scientists Allege Mismanagement at Agency. CNN. http://www.cnn.com/2009/POLITICS/01/09/fda.scientists/
* ↑ Harris, G. (2009, Jan 12). In F.D.A. Files, Claims of Rush to Approve Devices. The New York Times. http://www.nytimes.com/2009/01/13/health/policy/13fda.html
* ↑ Harris, G. (2010, Mar 28). Scientists Say FDA Ignored Radiation Warnings. The New York Times. http://www.nytimes.com/2010/03/29/health/policy/29fda.html
* 1 2 3 4 5 6 Lichtblau, E. and Shane, S. (2012, July 4). Vast F.D.A. Effort Tracked E-Mails of Its Scientists. The New York Times. http://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html?pagewanted=all
* 1 2 Reports From FDA Surveillance Operation. The New York Times. http://www.nytimes.com/interactive/2012/07/15/us/15fda-document.html?action=click&contentCollection=U.S.&module=RelatedCoverage&pgtype=article:%20documents%20showing%20enemies%20list%20etc.&region=EndOfArticle&_r=0
* 1 2 Gaffney, A. (2014, Feb 25). CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest. Regulatory Affairs Professionals Society. http://www.raps.org/regulatoryDetail.aspx?id=9978