On August 2, the Washington Post carried an article about the FDA retention bonus program – "FDA’s Retention Bonuses Rise to the Top; Critics Say Money Goes to Managers, Not Scientists Coveted by Drug Firms" which was highly critical on a number of fronts regarding the bonus program. This issue has the attention of key members of Congress.
Over two weeks later, a letter to the editor regarding the FDA bonus situation appeared from Dr. Andrew C. von Eschenbach. It appeared on a Saturday, August 18 edition in the letter-to-the-editor section of the Washington Post. Since it was regarding a front-page story, I thought the Saturday printing a little off-balance, so I thought I would offer what humble boost I could give to its circulation. Here is the letter in its entirety.
Regarding your Aug. 2 front-page article "FDA’s Retention Bonuses Rise to the Top; Critics Say Money Goes to Managers, Not Scientists Coveted by Drug Firms":
The article made erroneous conclusions about recipients of retention bonuses and their achievements.
Contrary to what the article reported, more than 90 percent of the $13 million pool of retention bonus money went directly to the Food and Drug Administration’s physicians and scientists. Members of the Senior Executive Service and other managers received 9 percent of that bonus pool.
The article mischaracterized the many contributions of two senior executives who received bonuses. Margaret Glavin effectively oversees the FDA’s nationwide field operation of 3,200 employees as our first line of public health defense. She established the FDA’s Office of Counterterrorism Policy and Planning and has received two Presidential Rank awards.
Terry Vermillion, also a recipient of the Presidential Rank Award, founded the FDA’s Office of Criminal Investigations and has led more than 4,600 national and international criminal investigations, resulting in 4,338 arrests, more than 3,100 convictions, more than $2.15 billion in fines and $750 million in assets forfeited to the Justice Department.
Responsible use of pay flexibilities helps the FDA find and keep expert, dedicated employees — and it has proven essential to our ability to fulfill our public health mission.
— Andrew C. von Eschenbach
If, as Dr. von E. states, Terry Vermillion founded and has lead all those THOUSANDS of investigations and gotten THOUSANDS of convictions, why hasn’t Mr. Vermillion investigated Dr. Howard I. Scher of Sloan-Kettering and Scher’s alleged UNREPORTED Conflict of Interests when he sat on the March 29th Provenge FDA Advisory Committee meeting.
Allegations of Scher’s possible violations have been made to the OIG at the FDA and are posted all over the internet and in the media; yet, nothing appears to be happening as to an investigation of the allegations against Scher.
So the one’s I’m acquainted with and which are found on the internet are available to Mr. Vermillion… here are those which I allege Scher may have:
Scher reported only 3 COI’s to the FDA per his filing in late February available at the FDA website which appears to be composed of ownership of 1 stock and 2 competing industry interest.
Internet research shows the following for Scher thus far and please particularly note #1 and #16:
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
14. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
15. MEDIVATION, INC: principal investigator MDV3100
16. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI’s found so far on the internet. It seems incomprehensible for someone with the training and education Scher has to “forget” so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.
Even more disturbing is the FDA’s Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI’s than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.
As a “temporary government employee” at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn’t, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.
Mr. Vermillion, here’s your chance to look into public allegations against Scher having more COI than he reported to the FDA which appears to violate Federal laws and regulations…. care to look into it?