Provenge Protest Planned For ASCO Meeting
16 CommentsBy Ed Silverman // April 17th, 2008 // 2:28 pm
A year after approval of the Provenge prostate-cancer vaccine was delayed by the FDA, a determined group of prostate-cancer patients - and some investors, too - plan to stage a series of nationwide protests that will include the largest annual gathering of oncologists, two organizers tell us. The events are planned by a non-profit called Care To Live, which is battling the FDA in court in what has, so far, been an unsuccessful attempt to force the agency to reverse course.
The specter of a protest is likely to unnerve the American Society of Clinical Oncology, because threats were allegedly made at last year’s event against two cancer docs who were dissenters on the FDA panel that recommended approval for Provenge. After the FDA panel meeting, those two docs - Howard Scher of Sloan-Kettering Memorial Cancer, and Maha Hussain of the University of Michigan - wrote FDA officials urging the go-slow approach that the agency adopted.
The behind-the-scenes machinations caused a firestorm - cancer patients have rallied outside FDA offices, and the controversy further fueled a debate about the use and approval of experimental meds. The lawsuit, meanwhile, 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 of the approval.
In recent weeks, the non-profit has taken to running advertisements in newspapers in Maryland - where FDA headquarters are located -featuring people who are suffering from prostate cancer. The latest, however, features a pointed and bitter essay written by an engineer from Houston whose father passed away last month while waiting for the FDA to approve the vaccine, which is made by Dendreon.
Hat to Life Sciences blog
Kyoto27
Strange how the ‘alleged’ threats against Scher & Hussain still remain ‘alleged’ –as neither have provided any evidence or proof from local police or the FBI that the threats in fact were real.
Maybe the two doctors confused any threats made by their ‘handlers’ to derail the Provenge approval ‘or else’ –with CTL’s cry of foul play by the two doctors and the FDA in denying due process to the Provenge NDA?
Also interesting to contrast the absence of action by law enforcement in the Scher-Hussain alleged threats—and the immediate action by FDA agents swarming down to a local florist to find out who sent roses to vonE –when the sender, Mr Cohen, clearly identified himself as the sender.
IMO the only real threat to Scher & Hussain was the impending danger or harm to them from their self-inflicted insomnia. Guilt does that to people…?
joey takasugi
Hi. You say:
“The specter of a protest is likely to unnerve the American Society of Clinical Oncology, because threats were allegedly made at last year’s event against two cancer docs who were dissenters on the FDA panel that recommended approval for Provenge.”
You think it strange after year you still need say “allegedly” made? If there threat, which police department this reported to? Can you find out? Can you get copy of police report? Find out what investigation made? Many people suspect this a total fabrication. It time someone clear this up once and for all.
tia.
Ed Silverman
Hi Folks,
I’ve been through this point before over the past year. Hussain has told me, by way of e-mail, that she did receive threats. A spokeswoman for Sloan Kettering has told me the same thing concerning Scher.
But neither would say anything specific about the threats, or how or where they were reported. They say threats were made, so I report that - and use the word ‘allegedly’ since no further evidence is offered.
By the same token, I don’t discount the assertion to the point of choosing not to report it, even though some may believe it is designed to deflect attention. I’m not in a position to judge.
Regards
ed
MyPharmalotID
What’s interesting about this whole issue over alleged threats is that when they were participating in the Provenge Advisory Committee activities, both Drs. Scher and Hussain were acting as “special government employees.” Under those circumstances, one would think that any threats made in association with those activities would be investigated, for example, by the FBI, acting in the interests of protecting federal employees (which Drs. Scher and Hussain indeed were considered). Yet, there is no indication that either the FBI or, for that matter, HHS OIG was involved in any investigation related to these threats. They remain unconfirmed, and in fact, may be, as some have surmised, red herrings.
crash
cops investigating cops? gimme a break.
David Friedline
If we’re to talk about threats, how about the threat to my life as a consequence of the FDA ignoring its own advisory committee through the internal lobbing efforts of Drs. Sher and Hussain
Seeks The Truth
Is it possible that the chemo cartel, knowing how much a revolutionary product like Provenge would adversely effect their obscene profit margins on cancer therapy, may have “threatened” Scher and Hussain?? It would have been easy to carry out such an act. Obviously, Scher and Hussain wouldn’t ever be able to reveal where those “threats” came from, would they.
Scher and Hussain have MILLIONS of dollars of research grants and fees coming their way from the chemo lobby.
I would NOT be shocked to find out that “threats” were made.
But where they came from might be shocking.
I suspect that Kerry Donahue and other vocal CTL advocates
will soon be “threatened” as well. The chemo-cartel for PCa treatment will not stand idly by while their strangle hold on therapy for advanced PCa is loosened by immunotherapy.
Ray Beane
When CTL has documented proof of undisclosed financial conflicts of interest its “Claim” But when Hussain with
no proof or evidence that a serious Threat was made on
her its “allegedly”. You need to push for some deeper proof
of these threats otherwise you are helping Hussain and company paint CTL and other Provenge supports with this
black mark.
Ed Silverman
Hi Ray and others,
I’ve been repeating this over and over this past year - I’ve asked Hussain and SKMCC to verify the claims of threats, but they haven’t done so. I can’t make them do so.
As to police reports, it’s a big country. If there were police reports filed, they could be anywhere - where a threat originated or was received. I continue to mention the alleged threats because they insist threats were made. I’ve not been offered proof, so I use the word alleged. And while I understand this infuriates some people, its part of the story.
As to the use of the word claims in connection with the undisclosed conflicts of interest cited by Care To Live, ‘claim’ is generally used to describe accusations or charges contained in a lawsuit.
I understand your frustration, but I’m not the judge and jury. I’m a journalist. And I’ve got a blog to run, a 15-hour-a-day gig that requires I pay attention to several topics simultaneously on a regular basis. I’m doing the best I can, but I’m being asked to prove a negative and, unfortunately, I’m unable to do so.
I hope this helps,
ed
CMCguy
Ed I understand your use of alleged in journalistic sense which is similar to what police say about suspects before a trial. However I can see where providing proof could be difficult and may not exist if was verbal or gestures with no witnesses to support.
At the same time I don’t think we have to allege that Seeks the Truth is a wacko since he has provided the evidence himself.
Sharon Romero
I think the two accused co-conspirator corrupted doctors decided that a threat against their lives would accomplish two things at once (1) to paint the whole group of people supporting Provenge with the wide stroke of fanatics and (2) create sympathy for the plight of these poor physicians who were being erroneously accused of unethical and illegal tactics.
Tony F
Ed, you and I discussed the “alleged” Scher threat(s) back in the fall and at that time I challenged you to do these 2 things:
1. Ask Scher directly if he had reported the UNsubstantiated and ALLEGED “threats” to the police? Yes or No
2. If yes, to which one? If no, why not?
In addition, in our short discourse on this topic, I suggested you make an inquiry with the NYC and the Tenafly, NJ (Scher’s residence) as to whether or not Scher made a police report–and, tell them the “why” of your inquiry… Scher is alleging such threats publicly in the media.
Clearly, if the NYC and Tenafly, NJ cops have no report, I think you’d find reader criticism dropping if you amended your writing to “alleged threats” and add your findings to Scher’s allegations… “which cannot be substantiated by the XXXX police departments.”
As noted all the time in the media, it is a VERY simple matter to trace ISP/email info… not rocket science at all. All that’s needed is the email and a look at the header info.
I also believe you’ll find a lot less criticism about your use of the terminology of “alleged threats” if you will instead say that they are “unsubstantiated alleged threats” or “alleged, but unsubstantiated, threats” to clarify that they have been made, but not proven.
As a bonus for the readers of your blog, let me also remind folks that Scher certified to the FDA that he had 3 Conflict of Interests. Net research suggests he has these 17 (SEVENTEEN):
Please particularly note #1 and #17 and, Scher, how do YOU explain the difference between your FDA certification of 3 COI and the following 17?????
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. 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
Lastly, Ed, the above complaint has been submitted to the HHS Office of Investigative Services and to the FDA Investigative department without response from them that they are conducting an investigation of these allegations against a “Temporary Government Employee” as Scher was when he sat in judgment of Provenge a year ago.
However, as we know know, 2 investigators reacted within 1 business day to go to a DC florist’s and ask for the names and other personal identification of two individuals who sent floral arrangements to Dr. von E., FDA Commissioner, on the 1 year anniversary of the FDA AC meeting.
How can the FDA react so timely to 2 floral arrangements sent while they continue to stonewall and fail to acknowledge receipt of complaints against Scher?
Something’s really wrong with this situation especially when 83 men die daily from prostate cancer… “allegedly”, many can have their lives extended with the safe treatment when given early enough.
Oh, and Thank You! for your continued following of this story in an honest and fair way.
Tom
Sharon Romero I agree! Your post hit the nail right on the head!
Hard Ball
I can’t help but agree with everything written here so far.
Scher/Hussain make a “claim” that there were death threats, a claim that when they are asked to verify they have kept siloent about by ignoring the question with an air of disregard and superior indifference. That so speaks to the reason one might reduce the term “alledged” to “an unsubstantiated claim” within the media at large. As for you Ed, people know that you are on the same page as the rest of us, however, you could, I guess, take the lead and lead by example.
Three people sent flowers to the FDA, not two… I know, I was the third. I also received a call from the flower shop G Men and Women. It strikes me as odd that a true “death threat” would not receive even more attention than some roses and daisy’s.
Thanks, Ed, for your in depth coverage of Provenge and of the wide spread corruption of the corporate/government partnerships.
Ed Silverman
Hi Hard Ball,
Thanks for your note. A couple of quick things. In my view, the word ‘alleged’ serves the same purpose. And I’ve addressed the overall issue previously, including in earlier comments listed above. Apart from that, I’ve tracked this story because it speaks to a couple of cotentious issues - the way the FDA handles the conflict-of-interest topic and the clamor for experimental medications.
Thanks for writing in,
ed
Patrick Bennett, MD
RE: Alleged threats made against Drs. Scher and Hussain last year.
I too will match any contribution to the charity of their choice up to 500$ for any person(s) able to provide verifiable evidence to Ed Silverman of Pharmalot that such complaints were filed by one or both parties with any local, state, or federal agency.
This is a system so rigged that a corporate researcher like Scher gets more sympathy, for complete BS, than the 30,000+ prostate cancer victims who have died since Pazdur and his authoritarian regime rejected Provenge.
pb