|William Maisel, who is the deputy director for science at CDRH, has been a proponent of in silico clinical trials.|
If they weren’t all potentially related in a serious way to each other, you’d be tempted to throw up your hands in despair.
The first part of the story—nine CDRH scientists’ allegations to Congress and others that managers coerced bad decisions out of them to please industry—has been related numerous times, so I won’t go into details again.
As I see it, the troubling if tortuous and tenuous string unravels this way. In attempting to quell the whistleblowers’ complaints, CDRH initiated FDA chief counsel’s office-approved clandestine electronic monitoring of their government computers, including new spyware.
In the course of this, private emails and home computers were allegedly invaded, including the whistleblowers’ communications with Congress and private parties, including journalists.
On top of that and coincidentally, 510(k) documents that were attached to some of the communications were accidentally released in public cyberspace by an FDA contractor, raising the specter of FDA hypocrisy in accusing its employees of leaking government-protected industry documents when it was in effect doing far worse itself, albeit accidentally.
At this point, you should consider the whistleblowers’ claims that even if they had shared industry 510(k) documents with Congress in order to support their arguments that CDRH managers were directing improper results in their 510(k) reviewers, Congress is part of the government and held to the same confidentiality standards as FDA with respect to those documents. In other words, they say, Congressional receipt of those documents is privileged by law.
This is an old and, to my mind, unsettled issue at law – but for current purposes here, a digression.
The tangled string continues. In the course of all this, it turns out that Dr. Maisel was late in July arrested by county police in Maryland and charged with four counts of soliciting prostitution and one of disorderly conduct, during a police “sting operation” on a public highway. An FDA spokeswoman, Erica Jefferson, publicly dismissed this as a “personal matter that has nothing to do with the work he does at the agency.”
But now enters the National Whistleblowers Center , which in a letter to HHS secretary Kathleen Sebelius asked whether FDA had shown a “double standard” in the Maisel affair vis a vis the whistleblowers case, since Maisel was the official who authorized the termination of one of the whistleblowers, “Dr. Ewa Czerska, a female 23-year veteran civil servant.” Czerska, the letter said, “is a member of the original ‘FDA 9,’ who filed significant health and safety complaints to various appropriate authorities. Prior to her discharge, Dr. Czerska also filed a Title VII sex discrimination complaint.”
The letter asked Sebelius whether FDA will “assist in the criminal prosecution of Dr. Maisel by conducting targeted surveillance of Dr. Maisel and all of his known associates? Will the FDA use targeted surveillance to develop additional evidence of crimes committed by Dr. Maisel or any of his ‘cohorts’?”
NWC told Sebelius that Czerska’s computer systems were extensively monitored and that resulted in the collection of “private and personal information,” including confidential information related to her sex discrimination complaint, as well as her Office of Special Counsel complaint. Questions posed to Sebelius include:
“When FDA managers were looking at Dr. Czerska’s personal communications, what safeguards existed to prevent a person who may be engaging in sex crimes from looking at her most intimate emails?
“What background screening did the FDA require to ensure that persons who had access to highly private and confidential internet/computer information (including access to passwords that could permit persons to access employee bank accounts, transfer money, or access medical records) had the necessary good character to be granted access to such information?
“What background screening was given to every FDA manager who authorized the scope of surveillance on Dr. Czerska (or any of the FDA whistleblowers who were the target of the spying operation) and/or had access to any of the whistleblowers’ private email?
“Did Dr. Maisel have access to Dr. Czerska’s personal emails or the personal emails of the other whistleblowers?”
There is an element of salaciousness here, and also the never-easy issue of when ostensibly “private” behavior by high public officials should lose its privacy.
U.S. Code Title 5, Part 2635--Standards of Ethical Conduct for Employees of the Executive Branch, Subpart A, Section 2635.101 Basic obligation of public service, states: “Employees shall endeavor to avoid any actions creating the appearance that they are violating the law or the ethical standards set forth in this part. Whether particular circumstances create an appearance that the law or these standards have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts.”
An uproar on my Web site among FDA employees occurred after the Maisel arrest was published. One commenter with an apparently legal background wrote: “Solicitation of a prostitute is a crime. This was a police sting, therefore there is likely videotaped evidence of the activity. Such behavior clearly violates the standard of ethical conduct for executive branch employees cited above. Not only is solicitation of a prostitute unethical and illegal, it sets up an opportunity for other criminal behavior such as extortion by the prostitute. While we wait for the legal proceedings to take place, it is hard to believe that Dr. Maisel is innocent of the crimes for which he is charged, since they occurred as part of a police undercover operation. As second in command at CDRH, he can hardly return to his leadership position unstained after this breech of the law and ethics. The questions raised about how FDA responded to Dr. Maisel's arrest are appropriate and valid.”
As has often been observed in other cases, FDA management has a long track record of reflexively protecting its own.
That is precisely why it did not deal adequately with the nine CDRH whistleblowers’ complaints in the first place and now has a much more awful mess on its hands.
Hopes that it will be able to comprehensively and quickly deal with industry’s many issues concerning product reviews and timeliness must be faint until all this is settled.