What Mistress? The FDA’s Top Cop Is Retiring
10 CommentsBy Ed Silverman // November 23rd, 2010 // 12:18 pm
Perhaps this is a coincidence. But after months of sour news about the performance of his FDA unit, Terry Vermillion yesterday announced to FDA staff that he is retiring next month as the head of the agency’s Office of Criminal Investigation. An FDA spokesman acknowledged the retirement, but declined to comment.
The move comes after the US General Accountability Office issued a report earlier this year that found the FDA’s Office of Criminal Investigation suffers from lax oversight, despite increased in funding and staffing over the past decade (here is the report). That followed criticism two years ago by House Republicans who expressed concern the OCI was overly emphasizing drug-abuse cases instead of pursuing researchers and drugmakers that commit crimes when seeking approval for meds.
Last month, however, Vermillion made news again when US Senator Chuck Grassley, who requested the GAO report, wrote the agency to complain that its findings “were less than stellar.” He did so after hearing from an unnamed whistleblower, who charged the GAO report was compromised by a mole. And several of the complaints in the report were leveled specifically at Vermillion, who is a retired Secret Service agent (back story).
For instance, Grassley wrote to the GAO that, according to the whistleblower, Vermillion relocated his domicile to the Hampton, Virginia, area and directed OCI work predominantly over the phone; he allegedly used OCI technical support staff and his IT staff to do personal work for him; and he allegedly authorized payment for government contracting training at George Washington University for a fellow OCI employee characterized as his ‘office mistress.’
According to Grassley’s letter, Vermillion also allegedly directed reports prepared by OCI’s Office of Internal Affairs were sanitized of derogatory info about his fellow US Secret Service retirees now working at OCI, and regularly had OCI training session and conferences held in the Dallas, Texas area so that he could visit family - a son and grandchildren, the letter states
Paul Thacker
Another Grassley scalp!
mypharmalotID
Maybe if we had reputable people working at the highest levels of the FDA, not only would this not have happened, but Provenge would have approved in May, 2007, as well.
Who will be the next to go? Many come to mind!
Where are the checks and balances in the system? Do these people think that the laws we, the ‘little people’ must follow, do not pertain to them?
We have the best government that money will buy!
Paul
What is troubling to me is not only that Terry Vermillion did not display the integrity that such a position requires, but that the GAO which was investigating the Director and the OCI, actually tipped Terry Vermillion off to the ensuing GAO investigation. (according to an OCI whistleblower)
The levels to which the corruption goes is staggering. Our Government is captured at all levels!!! The very regulatory agency empowered to act in the public interest (GAO) instead acts in favor of special interests. And the same can be said for the FDA if its own OCI department refuses to investigate and pursue drugmakers that commite crimes when seeking approval for new drugs.
Tony F
Yet another great Ed Silverman revelation….
Perhaps Vermillion’s action(s)is/are part of the reason my two written complaints to HHS and FDA OIC concerning Howard Scher’s Conflict of Interest (COI) signed statement (affidavit) to the FDA in early 2007 contained only 3 self-disclosed COI while net research showed he had something like 17 (Seventeen) COI–including being involved in a competing drug trial he failed to disclose to the FDA, as I recall; my written complaints went nowhere at either HHS or FDA including even an acknowledgment from either office of a written complaint of Howie’s COI.
While allegations of massive, undisclosed Conflict of Interest by Howard Scher of Sloan Kettering were made and ignored, the FDA OIC had agents at a floral shop the same day a supporter sent roses to Commissioner Andy von Eschenbach.
As a citizen, I find it unconscious-able, wasteful and lacking in fairness and ordinary common sense to spend funds and manpower to instantly force a florist to reveal who sent Andy roses, but ignored two written letters accusing Howie of alleged and undisclosed COI.
Long-time readers of your column know Scher was one of the FDA, hand-picked Advisory Committee members assembled to review and make a recommendation to the FDA in March 2007 about Dendron’s Provenge for end-stage prostate cancer victims–up for approval in May 2007.
Men have died at the rate of 30,000 each year; the FDA turn down sentenced 90,000 men over the additional 3 years it took to gain FDA approval to an earlier, more painful death than had Provenge been approved by the FDA in May ‘07 rather than in April 2010.
The Advisory Committee voted 17-0 that Provenge was substantially “safe” and 13-4 that its trial data showed efficacy–Howie being 1 of the “No” votes.
Unbelievably, the FDA ignored its own AC members vote… almost unheard of… and turned Provenge down in 2007.
Then, there was the issue of someone–never investigated or disclosed to my research and knowledge–about the change to a non-standard question of efficacy which had to be corrected in order to get the AC vote taken properly and as correctly prescribed by FDA regulations…. another OIC foible.
After the overwhelming positive AC vote, Howie couldn’t sleep and felt an irresistible compulsion to write a highly negative “Confidential” letter to FDA Commissioner Andy von Eshenbach–with the help of others including Allison Martin of NIH or NCI–since departed to what appears to be the believed stepping stone from government service into private (and more financially lucrative) employment. Allison and her agency had nothing whatsoever to do with the FDA approval process (per CTL FOIA document discoveries).
Somehow, as yet undetermined, 3 “Confidential” letters conveniently and mysteriously were leaked and printed in the “Cancer Letter”, a thought of as a rag publication printed in the basement of a private DC home by a Russian emigree and his wife.
Howie’s letter appeared 1 week; Maha Hussain (another “No” A/C voter from U of Michigan) appeared another week and the 3rd “Confidneital” letter miraculously was written by Thomas Fleming, PhD of U of Washington (State) appearing in a third week’s publication; Phlegming had nothing to do with the AC meeting and how was, as I understand, likewise conflicted having allegedly done some statistical work for Dendreon at one time or another prior to his anti-FDA approval letter writing.
While outside the scope of this OIC “retirement”, recent news reports suggest the FBI is doing the SEC’s work with alleged stock fraud, insider trading and other illegal financial transactions–particularly by hedge funds–instead of the SEC.
No wonder Main Street’s average Joe citizen lacks confidence in our government with the apparent massive fleecing of the citizen’s by those who occupy supervisory positions in the multiple alphabet soup of our government’s many agencies and who appear to have a cozy relationship with those in the private sector they over-see and regulate.
Thank you, once more, Ed for bringing this topic to light!
Glad your back; I missed your many incisive and fairly reported articles!
Tony F
Virginia Beach, VA
moonshooter
Hmmmm? No wonder Arena’s Lorcaserin advocates and investors smelled a rat at the FDA. The place is infested with ‘em!!!
Go get ‘em, ED!
According to a post on the IV Arena board there is an ongoing investigation into the Arena AC that is supposed to be made public. We shall see.
http://www.investorvillage.com/smbd.asp?mb=633&mn=9397&pt=msg&mid=9793685
Anne PME
This is sad to see…as congress looks at budget cuts I hope that they consider that someone like Terry Vermillion will probably retire with a good government pension and benefits that are guaranteed
Wouldn’t it be ironic if that those who continue to work at FDA OCI to try to put back the pieces and right their reputation are rewarded by loosing aprt of their government pension and/or retiree health benefits because of budget deficits?
CAH
I hope the investigation of Vermillion is not discontinued just because he retired. Unethical (and possibly unlawful) activities by current and former government employees should be brought to light and appropriately acted upon. How can the government earn the public trust unless it investigates and takes appropriate corrective and preventative action?
tmk
vermillion is and always has been a fraud.
if the gao digs a little deeper into this guy
they will find gross negligence and criminal
activity.
FDA OCI
OCI is managed by the laziest and most incompetent criminal investigators in government, who simply leech onto the drug investigations of other agencies to get easy statistics. Vermillion, as head of the corrupt snake, has padded his pocket and his career by making sure his friends “work” from home.
Vermillion’s cronies, no doubt the same for whom he falsified personnel records, will probably find him a cherry job in the industry he was suppose to regulate in order to keep Vermillion’s corruption afloat. The main problem is how easy it was for such an idiot to be so corrupt.
BESDA
I notice no one says anything about how our Congressman rake in the money and exempt themselves from every law passed - cut in pay to all federal workers but themselves - let’s get serious people. Look at our economy and let’s think twice about who the criminal is. Those that accuse are generally the one commiting the crime.