A science-based agency would never throw out Provenge’s statistically significant survival data because it missed its endpoint of Time to Progression (TTP) by two one thousands of one percent (especially as TTP is a ‘surrogate’ endpoint for survival and one that Richard Pazdur admits does not measure up to stat sig survival data). Furthermore, the FDA knows that a miss of .002 is not in fact a miss, and would be more properly defined as being ‘nominally significant.’ The FDA also knows that had Provenge been measured from time of patient treatment rather than from time of patient randomization it would have more than met its TTP primary endpoint—because like every adult that takes a flu shot knows, vaccines require a period of a few weeks to ramp up. Something the ‘chemocentric’ thinkers at CDER would like to overlook?

So saying that perhaps the FDA refused to approve Provenge because Dendreon hasn’t been able to provide the data necessary to show that the vaccine actually works really highlights the fact that Provenge works and has all the data needed to show that it works for any true science based agency/or individual that’s interested in trulyu studying that data ( & not trashing it in tabloids like The Cancer Letter).

So why did Richard Pazdur, Dr Howard Scher and Maha Hussein conspire to de-rail Provenge?

Maybe because all the data and science show that Provenge works?

They know their guilt. And many of those with any conscience at all have left. Drug safety at the FDA is a joke.

You sound like you’ve lost someone close because of the failures at the FDA; if true, I am sorry for you loss!

The FDA’s first reason to exist - “to protect the public from harm”, as you wrote, cuts both ways… don’t approve products too hastily as well as don’t withhold those–like Provenge–who have a demonstrated safety profile and shows strong, but not convincingly enough data to the FDA, from terminally ill patients.

The Provenge story is exceedingly interesting and much information can be found on the Care To Live website as well as numerous investor forums such as Investors Village… you might just check it out to see how badly terminal patients are being treated except a wealthy or powerful few. (You may recall the Fred Barron story where Clinton, Kennedy and others persuaded the FDA to allow an UNapproved clinical trial treatment be used in his terminal case).

Additionally, the Provenge story shows the FDA held a panel of their own selected outside experts to judge Provenge. Two panel members had significant conflict of interests (COI) which they failed to disclose to the FDA. Here’s one example.

One doctor’s Conflict of Interest situation in the FDA Provenge Advisory Committee meeting in March 07; these are the alleged COI for Dr. Howard Isadore Scher of Sloan Kettering in NYC.

In order to sit in judgment of Provenge, Scher certified to the FDA that he had 3 Conflict of Interests. These 17 (SEVENTEEN) have been found on the internet for Scher.

*** NOTE particularly items 1 & 17

1. NOVACEA:
Grants & Research support;
STUDY CHAIR of DN-101;
Clinical trials since failed & halted
…. and 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 competing treatment
Advisory Board

8. INNOVIVE PHARMACEUTICALS:
Principal Investigator competing treatment

9. INFINITY PHARMACEUTICALS:
Principal Investigator competing treatment

10. BIOGEN-IDEC:
jointly held stock with spouse

11. PFIZER:
jointly held stock with spouse

12. GENTA:
Scientific Advisory Board (as of Mar 6, 07; since removed but cached)

13. CONFOMA THERAPEUTICS:
Scientific Advisory Board

14. DEPARTMENT of DEFENSE:
Principal Investigator PC Clinical Trials-P1 and P2

15. AMBRILIABIOPHARMA INC:
Principal Investigator PCK3145, Phase I/II

16. MEDIVATION, INC:
Principal Investigator MDV3100

17. PROQUEST INVESTMENTS,
…. Board of Directors
…. Advisor
…. Novacea INVESTOR (direct competitor to Provenge)

Despite the above being reported to the Health & Human Services investigate office and the FDA investigative office, nothing has been done for almost two years to investigate these allegations that Scher may have violated the law by his apparent failure to disclose ALL his COI.

Additionally, the bandied about 4.5 months MEDIAN survival doesn’t men average… it means MEDIAN (1/2 total population lived longer and 1/2 lived shorter); typically, survival time FAR exceeds the MEDIAN.. several have survived more than 7 YEARS and all have had an increased Quality of Life when compared with the serious side effects of chemo.

Finally, remember that Provenge is a treatment for TERMINAL prostate cancer victims… it’s not about an aspirin, a vitamin or an OTC supplement… this is about life and death.

83 men die DAILY from prostate cancer and more than 47,746 have died just since May 9th ‘07 when the FDA postponed Approval/Conditional Approval for Provenge… a treatment all AC members voted to be “safe” by a 17-0 ballot.

Look into this tragic story; you’ll be further shocked at how disfunctional the FDA is.

Tony F

Then in IDMC report showed additional 20% survival at in interim look (which is a peek at what is happening before the current (3rd) phase III trial is finished) overe the current standard of care. While the final results will be more robust the patients ask “why wait”. With the added evidence from the IDMC in October, the 1 in 40 chance that Provenge does not work is a more favorable number (in other words there is now more like 1 in 16,000 chance that Provenge results have again been obtained by mere chance).

The thing is that the FDA is friendly and hob knobbing with these big pharma folks every week. These big Pharma folks do not want Provenge approved because it will cost them money. The FDA is influenced by them and continues to be so as they unnecessarily delay the approval of Provenge to help these big rich friends of theirs. The main front person (friend) between big pharma and the FDA is Janet Woodcock.

The FDA won’t consider that Bruce, Ray and Eduardo and others took Provenge in 2001are still doing well despite the average 17-19 month life expectancy from diagnosis of AIPC. That’s not “data” and the FDA won’t use common sense and humanity when evaluating a treatment for a late stage patient group even though they have no alternatives to death. This defies reason and common sense in the name of statistical purity.

The FDA admits (January 2008) it is unable, with the resources it has, to evaluate innovative new treatments yet it over rules the experts brought in that do know how to do it.

The current FDA is an arrogant and inhumane agency that cares nothing for the patients. This will hopefully change when the new commissioner reorganizes and removes the entrenched bureaucrats that are abusing their power. Maybe then we can get the transparency and accountability the people deserve.

If the Care to Live group (and the Dendreon investors) really want to get to the bottom of this why don’t they request Dendreon to make public the non-approval letter (which I admit is unlikely because of commercial-in-confidence information). Remember that the FDA is also bound by Dendreon’s commercial-in-confidence arrangements.

The interim analysis beside, FDA advisory members that work for competeing companies should not have a place on such committees.

But where is the passion for all the drugs that the FDA approves that kill people? Is this not the greatest travesty of this pathetic agency? Think of all of us who have lost our children or spouses to drugs which had no warnings on the label, whose makers have suffered nothing but meager fiscal consequences, who have not gone to prison. Who knew but hid the lethal side effects?

I only say this as I see no perspective in this discussion as it deliberates the purpose of the FDA. Except for the post which gave as FDA’s first reason to exist - “to protect the public from harm”. This is their biggest failure.

I realize you do not have adequate credentials or expertise to interpret the data that has been published by Dendreon, so I am amazed that you could be so opinionated and have the audacity to recommend shorting DNDN stock.

I would suggest you visit the Investor Village Message Board. There you will find much discussion by medical statistics experts, who believe that the data prove Provenge works. Who knows, you might even learn something, even though it is obvious from your columns that facts, objectivity, and accurate information is not something that you seem to value.

Your portrayal of a dedicated group of people as charlatans who are far more educated and knowledgeable on this subject than you and who are trying to save lives is a reflection of your character not theirs.

You are apparently transitioning away from being a second rate, hack “journalist” to becoming a failure as a stock picker. It is so obvious that you fear Provenge will get approval and that your short recommendation will result in you becoming even more irrelevant.

And that your meager audience will become even more so.