It’s A Small Prostate-Cancer World, After All
14 CommentsBy Ed Silverman // October 9th, 2007 // 11:43 am
This is one way to play connect the dots in the Provenge controversy. Before we explain, let us remind you that Provenge is the prostate-cancer vaccine that was recommended last spring by an FDA panel, but later put on hold after the agency received letters from two panel members urging a go-slow approach. The delay set off a firestorm - the two docs received threats amid allegations of conflicts of interest; and patients and investors in Dendreon, which is developing the vaccine, filed a lawsuit against the FDA, charging agency political intrigue was also involved.
And so it comes to our attention that FDA commish Andy von Eschenbach - who is named in the lawsuit and held responsible by cancer patients for the Provenge delay - has a link, of sorts, to Howard Scher, a prominent oncologist at the Memorial Sloan-Kettering cancer and one of those two docs who were on the panel but cautioned the FDA to move slowly. The link is Michael Milken, the infamous investor. (That’s Andy and Mike pictured together).
Back in 1993, when Milken was diagnosed with prostate cancer, he helped form the Prostate Cancer Foundation, a non-profit devoted to underwriting research. Andy, another cancer survivor, was among those who assisted the start-up efforts (you can read Milken’s recollection in a 2004 speech here).
Milken was also an early investor in ProQuest Investments, a venture capital fund formed seven years ago to finance cancer therapies. One of those money-making opportunities is a company called Novacea, which is developing a different prostate cancer treatment and struck a potentially lucrative deal with Schering-Plough shortly after the FDA delayed approval. Scher and two members of the PCF ‘leadership team’ are scientific advisors to ProQuest. [UPDATE: Make that three members of the PCF team].
As a result of these links, speculation is growing that something less than arm’s length decision-making occurs at the FDA. An FDA spokeswoman declined to comment on whether Andy and Howard know one another, citing the pending litigation. A Sloan-Kettering spokeswoman has not yet returned our call. In the past, ProQuest’s chairman Jay Moorin has expressly stated that he doesn’t talk to the press. And we’ve left a message with the Prostate Cancer Foundation. There is nothing to suggest, however, that anything untoward occurred simply because this connection exists. Dots may not always create a complete picture. But it is a small world sometimes, isn’t it?
Ray
Hopefully Andy & Howie & the rest of the gang will realize just how small the world can get?
Let’s try a 10 x 10 cell
MyPharmalotID
“Curiouser and curiouser!†Cried Alice
This story just seems to grow more interesting, involved, and revolting with each passing day.
One has to wonder how much longer the house of cards can stand before the whole thing comes tumbling down around von E’s, Pazdur’s, Scher’s, and Hussain’s ears.
Matthew Jurmann
Ray, giving them a 10×10 cell is too generous.
Lucy
Ed,
Great story. PCRP, ProQuest Investments, Dr. Howard Scher and Dr. Andrew von Eschenbach all have one thing in common….Michael Milken’s PCF(Prostate Cancer Foundation)!
1. Howard Scher and Andrew von Eschenbach are key members of PCF since its inception
2. PCF soaks the well intentioned public to fund a cure
3. Andrew von Eschenbach setups up PCRP
4. PCRP soaks government
5. Howard Scher sits in review of applications for grants for both PCF and PCRP.
6. Milken set ups Proquest Investments a VC investment company that focuses on Prostate Cancer
7. Scher advises Proquest on best ideas both PCF and PCRP can find
8. Tommy Thompson is appointed by President George Bush
9. FDA Commissioner Crawford resigns because of unintentional failures to disclose his own financial holdings
10. President Bush nominates Andrew von Eschenbach to replace Commissioner Crawford.
11. Tommy Thompson, US Secretary of Health and Human Services, grants Andrew von Eschenbach a waiver for conflicts of interest without reason.
12. Andrew von Eschenbach is appointed FDA commissioner despite his own conflicts of interest
13. Waiver of conflicts of interest is issued to Howard Scher for his participation in FDA advisory meeting
14. Howard Scher sits in review of drug(s) that compete with Proquest’s portfolio
15. In spite of conflicted particpants participation, advisory panel overwhelming confirms that Provenge meets all the criteria for marketing approval.
16. FDA Commisioner, Andrew von Eschenbach, overturns advisory panel decision under the guise of science.
It is clear to me that the science and normal process at the FDA was overturned by a small group of people with inordinate influence and subverted the process. It happened with Plan B and it happened with Provenge. It can happen again. The Provenge advisory panel confirmed that Provenge met all the criteria for marketing approval.
There appears to be a related party factor that calls into question Dr. Scher’s and Dr. von Eschenbach’s true independence as a FDA panel doctor and FDA Commissioner. With such high powered contacts, Dr. Scher’s unmatched power and influence, Dr. von Eschenbach position and authority as FDA commissioner, is there really a level playing field for anyone in which Dr. Scher, ProQuest Investments (or its principals) does not have a financial interest in? This is an assault on the trustworthiness of the FDA and our government in general.
What is significant here is the amount of control and influence that Michael Milken possesses over the prostate cancer community, Dr. Howard Scher’s and Dr. Andrew von Eschenbach’s long and close professional relationship to Michael Milken and Dr. Scher’s and Dr. von Eschenbach’s authority and position within the FDA.
Knowing of Dr. Scher’s and Dr. von Eschenbach’s close professional relationship to PCF and Michael Milken, how is the public to believe that the FDA made the correct decision? Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant’s own sibling participating on a jury resulting in a hung jury decision. I fear the Commissioner himself was complicit in the Provenge decision. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests or under the auspices of science. The FDA subjected the terminally ill AIPC patients to more suffering whereby a few would benefit financially.
Hard Ball
Oh what a tangled web we weave,
When first we practise to deceive!
Sir Walter Scott, Marmion, Canto vi. Stanza 17.
Scottish author & novelist (1771 - 1832)
This is sounding more like a good book everytime you write a piece. Thank you for the continuing saga.
Kyoto27
Ed,
Thanks for keeping the Kleig Lights on this story. I have a suggested ad campign for Michael’s foundation:
“Milken Cancer For All It’s Worth”
He knows the money is made fighting cancer not curing it, or looking for a cure. And he must send out special thanks to his friends at the FDA, Memorial Sloan Kettering, Proquest for ‘protecting cancer’s right to live.’
This story smells worse with each passing day.
Chris
1 - good story with possible links back to Milken
2 - some ugly cynical comments here though
3 - Milken has plenty of money already
4 - who says he’s still involved with ProQuest? They’ve been around for years, very successfully apparently
5 - Novacea is only one of many investments they made. It won’t make or break the fund
6 - having survived prostate cancer is it unreasonable that he might want to use some of his money to fund a foundation that helps find better medicines (as apparently do shareholders in Provenge but for profit)?
7 - still, we’ll be watching closely
Ed Silverman
Hi Chris,
As always, you raise some good points. And I tried to avoid making any ‘ugly, cynical comments. I did attempt to point out that others are speculating something untoward may have occurred.
That said, I agree that Milken has plenty of money, and that Novacea is but one investment. Two ProQuest scientific advisors, a small group, remain on the PCF leadership team; a connection of another sort.
And of course, he got involved not just to make money but to promote research into better medicines. That’s why I wrote that dots don’t always form the clearest picture. I was just pointing out what’s circulating and some interesting, well, dots.
Cheers
ed at Pharmalot
Hank
Any headline which contains both “small” and “prostate” is good news to me….
Excellent reporting, wherever dribbles out from here.
paul1149
Here’s another powerful synopsis of this sordid tale to date, just out:
http://www.opednews.com/articles/genera_evelyn_p_071009_fda_industry_insider.htm
Looks like the story is getting out. FDA needs a major clean sweep. It’s authoritarian policies go against the spirit of our nation’s founding documents and principles.
p.
Chris
Ed,
I meant that some responses were unpleasant not the original piece. Getting tied up with my ‘posts’ and ‘comments’ I’m afraid.
Chris
Lucy
Ed,
In your article, you mention that there are 3 Prostate Cancer Foundation consortium members and officers that are key members of ProQuest Investments scientific advisory board. There are actually 4.
1. Besides Dr. Howard Scher, several other very notable Prostate Cancer Foundation consortium members and officers that are key members of ProQuest Investments scientific advisory board as well.
2. Dr. Stuart Holden is Medical Director to the Prostate Cancer Foundation and a scientific advisor to ProQuest Investments.
3. Dr. Howard Soule is an Executive Vice President to the Prostate Cancer Foundation and a scientific advisor to ProQuest Investments.
4. Dr. Jonathan Simons is the President of Prostate Cancer Foundation and a scientific advisor to ProQuest Investments.
http://www.proquestvc.com/scienceadvisory.asp
Tom Smith
IMHO what is needed here is a full investigation by the DOJ, SEC, and CONGRESS! In the end more than a few will be wearing orange jump suits!
Devin Rosario
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