The Provenge Anniversary: Roses For Andy
16 CommentsBy Ed Silverman // March 31st, 2008 // 2:11 pm
The ongoing controversy over the Provenge prostate-cancer vaccine took a strange twist today. A couple of dozen white roses were sent to FDA commish Andy von Eschenbach late last week and, this morning, a pair of special agents from the agency’s Office of Criminal Investigations visited the Rockville, Md., florist to learn who sent the long-stem missives, according to the florist.
But why was Andy sent roses? And what has this got to do with Provenge? You may recall the FDA last spring ignored the recommendation of its own advisory panel, which met March 29, 2007, and decided not to approve the Dendreon product. This turnabout came after two panel members - Howard Scher of Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan - took the unusual step of privately writing Andy and other FDA officials to hold off.
The behind-the-scenes machinations caused a firestorm - the two cancer docs say they received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome, although a federal judge has since tossed part of the suit and an appeal is under way.
To commemorate the event, a few investors and patients were brainstorming about the anniversary and at least two placed orders with All Seasons Florist. A woman who answered the phone and identified herself as Amy says the orders were placed and delivered to nearby FDA offices late last week. She sounded shaken by the visit from the agents, who left their cards, and she identified one as Mark McCormack, who is listed on the agency’s web site as an agent with the FDA’s Office of Criminal Investigations. UPDATE: An FDA spokeswoman writes us to say: “We donated the flowers to a local nursing home. Anonymous, unsolicited gifts are handled according to a standard security protocol to assure they don’t present any safety or security issues.”
We understand that one order was placed by Ted Cohen, who has been active in pressing the Provenge cause. “They were meant as a sign of mourning for the overturned, overwhelming recommendation to approve Provenge for end stage prostate cancer (17-0 on safety, 13-4 on the basis of substantial efficacy) by your own Advisory Committee,” Cohen wrote in an e-mail he sent this afternoon to the FDA commish, which he shared with us. “They also were meant to call attention to the egregious (conflicts of interest) attendant to Drs. Scher and Hussain, which have yet to be fully investigated and vetted by your agency and HHS.”
White roses, by the way, are often on display at funerals as a sign of remembrance. Hmmm… How should the FDA have interpreted the symbolism?
Hard Ball
No, tell me this is a joke.
Kyoto27
If I was agent Mark McCormack, I would sit down with Ted Cohen to learn the facts of the Provenge story and go after the real crooks in the FDA: Drs Scher, Hussein and Pazdur.
Looks like the FDA is even a more fantastic realm than than the ‘rabbit hole’ that gave us Alice’s Adventures in Wonderland. I don’t know if this is a case of ‘bathos’ or ‘pathos?’ One thing is certain, it is a miserably or contemptibly inadequate response from Andy to the real crime that was committed on March 29, 2007.
Poop Doggy
Let’s see…..plenty of time to send out the goons to trace some posies, but not enough hours in the day to track down Pazdur’s documents through FOIA. Pardon me while I adjust my nose plug. The stench is becoming overwhelming again…
Justme
This would be laughable except for the fact that over 26,000 men with prostate cancer have died, while it is business as usual at the FDA. The light is on but no one seems to be home. Why are OIG, FBI, Congress, news organizations (pharmalot excluded) GAO, etc looking the other way??
Tony F
Ed,
I’m stupified that any government agency, let alone the FDA, can leap into action in 1 business day and have it’s Office of Criminal Investigation spend the time and money to send two agents to find out who sent flowers to the Commish yet, over a period of some nine long months–despite having numerous requests to the HHS and the FDA–they cannot investigate the alleged UNdisclosed conflicts of Dr. Howard Isadore Scher of Sloan-Kettering.
As background, remember that Scher certified to the FDA that he had 3 Conflict of Interests in order to sit in judgment of Provenge on the March 29, 2007 Advisory Committee.
Internet research suggests that Scher has 17 Conflicts of Interest:
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101…
a 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. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. 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 17 COI’s found so far on the internet.
As a citizen, it’s totally incomprehensible that someone at the FDA is more interested in who sent flowers than in who may have committed a criminal act against not only the FDA but also the TERMINAL prostate cancer victims and their families.
shame, Shame, SHAME!!!!
scott
Two dozen white roses are a fitting remembrance for the thousands of Andy’s fellow citizens who died on his watch from prostate cancer unnecessarily early and painfully because of his failed leadership. Andy, do what is in patients’ best interests and resign, now. When you go, please advise the DHHS Secretary and the President to appoint as your successor someone with the leadership qualities (among them integrity, courage, vision, commitment to doing the harder right instead of the easier wrong) and a willingness to run the agency with the best interests of the public first and above all else. Sadly, those have been noticeably lacking during your tenure.
POOP DOGGY
“UPDATE: An FDA spokeswoman writes us to say: ‘We donated the flowers to a local nursing home. Anonymous, unsolicited gifts are handled according to a standard security protocol to assure they don’t present any safety or security issues.’”
Let me get this straight: It’s perfectly OK to send a bunch of evil flowers to a handful of poor, defenseless widows at a nursing home because Andy doesn’t have a big enough pair to accept them himself and ponder the message on the enclosure card? This is BEYOND BELIEF! Ed, your use of the term Byzantine regarding this whole thing is SPOT ON. Thank you for your continued coverage and the update.
doncl316
Sad & Amazing at the same time…history is repeating itself…we are watch the slow decline of a once great nation…what is right is wrong…what is wrong is right… USA - a bizarro nation…I have been a die hard Republican since birth (almost)…losing faith fast…
Greg K
I’m glad my tax dollars go to crap like this. FDA commish
sends 2 goons to flower shop to investigate?? WTH? This completely ineffective bureacracy can’t find critical documents in months, can’t find the correct plant to inspect, can’t find their a___ from Pazdur’s elbow yet they send goons to investigate flowers johnny-on-the-spot?
You gotta be kiddin me. When is someone with integrity going to clean house in the FDA? Scrap the damn thing entirely and start all over again.
paul_1149
If they donated the flowers to a nursing home then presumably they already knew they were clean. What are earth are they doing investigating the sending of harmless flowers? This sounds more like the soviet apparatchik than the American civil service. Or perhaps there isn’t much difference any more, eh Dr. von Eschenbach?
EEJ
How can the flowers be a safety/security issue for the people at the FDA, but NOT a safety/security threat for the peoplea t the nursing home????
Dr. Incognito
Ed,
You’ve made redscrubs.com’s Weekly Wrap-up Honorable Mention list again.
Congrats.
Sincerely,
Dr. Incognito
Ed Silverman
Thanks Doc. Does this mean I get roses? ed
Dr. Incognito
Don’t hold your breath ed.
But, if you keep up the good blogging we might get you a free set of red scrubs in the coming weeks. Wearing those to work just might get you some roses:)
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