Cancer Patients Ask Court For Provenge
11 CommentsBy Ed Silverman // September 11th, 2007 // 10:42 am
This isn’t surprising. Having already filed a lawsuit against the FDA for failing to approve the prostate-cancer vaccine, an anonymous group of cancer patients (and perhaps some investors) are now asking a federal court in Ohio to grant an emergency injunction that would make Dendreon’s Provenge available immediately to cancer sufferers. The move comes just before a planned Sept. 18 rally at FDA offices in Maryland.
The 55-page motion, which was filed by the recently formed non-profit, CareToLive, recaps the events surrounding the controversial FDA advisory panel meeting last spring in which Provenge was recommended for approval. Although at times the filing is sarcastic and rambling, the motion is interesting reading because it lays out a conspiracy theory that an FDA official, Richard Pazdur, allegedly orchestrated the subsequent approval delay and improperly leaked info about the matter to a newsletter. Another treat is a lengthy look at conflicts of interest involving FDA panel members.
Meanwhile, sources familiar with this mess say the FDA is conducting an internal probe into the alleged conflicts, although an agency spokeswoman declined to comment, citing the litigation. The allegations center on Howard Scher, a prominent physician at the Memorial Sloan-Kettering Cancer Center in New York, who is also an advisory board member to a venture capital fund that invested in at least one company developing a rival prostate-cancer med. As reported previously, this info wasn’t disclosed on his waiver forms prior to the panel meeting.
“The FDA has failed to act, continues to refuse to act, and it is clearly aware that it should have acted, in the best interest of the patient population it is sworn to protect,” the motion states. “Each and every day the FDA fails to abide by its own rules and regulations, and continues to ignore the purpose and intent of the Congressional mandate set out for them, including protecting the health and well being of the citizens of the United States…more than 80 men die without hope.”
brentb
So sad that the approval process is all about money and investment dollars. If Provenge was property of PFE or LLY, would approval been an issue.? Doubtful. This just enhances the bigger trend of patients going off shore for treatment and procedures. Provenge will ultimately be available, but probably not in the U.S.
Dr. A. Scott
Pressure is building daily on the FDA to investigate their own and to correct their failure to approve Provenge in some manner. The science speaks for itself as does the greed of others, namely Dr. Sher, whose overt bias is well documented.
Cancer patients will prevail…..but each day brings more unnecessary deaths.
drugrunner
it is a sad day for young biotechs when they are forced to partner their products with big pharma in order to even have a remote chance at drug approval.
When a drug is shown to be safe and effective ..
vote 17-0 and 13-4 by its own approval board, then denied to the patients who need it most. Dr Von Esch has explaining to do..
FDA:
WHY deny patients with no hope, their last chance at life. WHY?
Tony F
TWO major comments to another of your articles shining light onto this travesty… hopefully, Ed, you’ll find this added info interesting enough to check into them further and let us all know what you find.
I. SCHER COI POSSIBILITIES
I have previously posted about Scher allegedly having 10 COI found on the net… then, it was 13. Further research found 15 and then 16 and now, the possible list sits at 17…. and here they are:
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 #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
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. 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.
Hopefully, the new info provided in this article suggests that MAYBE, FINALLY the FDA investigative arm’s attention to this matter has been caught!
II. PAZDUR
It was noted this week that at the NIH, there is a Nurse Practioner by the name, Mary P. Pazdur, who is working on CANCER projects for NIH.
Internet research shows that Richard & M. P. Pazdur own real estate in surburban DC city in Maryland suggesting this NIH “M. P. Pazdur” and Richard’s co-property owner just may be the same person.
NIH website lists this: at the bottom of their page here:
http://ccr.cancer.gov/labs/lab.asp?labid=39
U.S. National Institutes of Health
National Cancer Institute
Center for Cancer Research
CLINICAL TRIALS CONTACT INFORMATION
For initial patient referrals, contact Mary Pazdur, N.P., the clinical trials liaison between patients and the physicians, at: Phone: 301-496-7870; Fax: 301-480-5094; E-mail: pazdurm@mail.nih.gov. For detailed information about these studies, including inclusion and exclusion factors, contact the principal investigator (see link on first page of “Lab pagesâ€). For more information about the vaccines used in these trials, click on the scientists’ and clinicians’ links on the first page of “Lab pages.â€
For more information, go to the National Cancer Institute’s Clinical Trials Web site.
—–
M. P. Pazdur is the author/co-author/mentioned contributor of some 20+ article concerning immunotherapy, chemotherapy and other cancer treatment trials.
Doesn’t it seem a bit too cozy to have the leader of the FDA cancer drug/treatment division–a very high and powerful FDA position–also have an alleged spouse who works in the same area at the NIH testing potential cancer treatments/devices?
This, to me, is too close of an intimate and personal association for my money…. what do you and others think?
Kudos on your continuing series of articles in this area!!!!
Kyoto27
Dear Ed,
Thank you for letting us know that the FDA may be “conducting an internal probe into the alleged conflicts, although an agency spokeswoman declined to comment, citing the litigation.â€
Given the hypocrisy and mental dishonesty displayed by Drs Scher and Hussein (as noted below in the CTL lawsuit), it would appear that the medical profession—and oncologists in particular should look at the duplicitous, scheming behavior of Drs Scher and Hussein with some alarm and outrage.
The duplicity revealed in the following excerpt from the CTL lawsuit is, IMO, an insult to every honest doctor in America:
“Further, Dr. Scher himself, who adamantly
opposed Provenge approval, said this, “It may be time we focus less on statistical
significance alone and more on patient benefitâ€. This quote was reported on February
26th, 2007. The report stated he said this at a conference sponsored by Novacea.
February 26th is the same day Dr. Scher signed his COI waiver (which turned out to be a
paritial conflict waiver). This is important because it demonstrates how when Defendant
Scher is evaluating a drug for which he has a financial stake, patient benefit is important.
When Dr. Scher evaluates his competitor Provenge, it’s a much different standard. Dr.
Scher likes to change the way he evaluates therapies according to whether his financial
and political interest dictates approval or denial.
One of the co-conspirators was Dr. Maha Hussain (Dr. Pazdur hand fed her
information to help her attack Provenge during breaks at the Advisory Committee) who
also changes her standards with the direction of the wind and/or her best interest. When
Dr. Hussain was voting on a drug called Tarvceva she stated even slight benefits are
significant in “a tough Diseaseâ€. Of course when it came to Provenge her opinion
changed. Maha Hussain reported in her conflict disclosure that she was the principal
investigator on a research contract awarded by a competing company for a product that is
not related to Provenge. She also disclosed that her husband owns stock in three
companies that compete with Provenge.â€
I hope you will continue to follow the truth in this troubling saga–for sake of good science, good doctors and every patient in America. Thank you again!
C. Payne
Just a note of thanks Ed for being so tenacious in following this story. Previously, I naively supposed that the FDA was exempt from the utter corruption which reins at so many departments in our government; afterall, people’s lives are at stake. Quite disheartening to realize that a completely safe treatment such as Provenge which demonstrates such promise, either as a mono-therapy or in conjunction with some form of T-reg suppressor such as Taxotere (as per Dr. Petrylak’s findings) can be so easily discarded by so-called men of science and compassion….thus basically abandoning those terminal patients with no hope or other acceptable alternative. Where is the outrage which should be sweeping the medical profession? Why is it so few are speaking out?
One last point…are you aware that though the target population in the Provenge P-3 studies were very advanced in their disease (avg. life expectancy of AIPC patients is only about 19 months), a number of the original Provenge trial recipients are still alive and well over 6 years later? The trials were stopped at 3 years…so the true effectiveness of Provenge is not fully reflected in the ‘official’ statistics.
Imagine what might be achieved were Provenge administered at an earlier disease stage and “boosters” were incorporated into the treatment regimen….(hint: research the information which Dendreon has revealed regarding the effect of “booster” infusions on immune response).
Sadly, as the age old maxim indicates…when things are confounding, simply follow the money. My guess is Provenge obviously represented a tremendous financial threat to the chemo dynasties of some very powerful pharmaceutical entities and those institutions and individuals with direct and indirect ties to them.
These end-stage prostate cancer victims were denied the one true breakthrough therapy to come along in years….they are very literally being sacrificed at the altar of greed and crass self-interest as the individuals whose duty was their wellbeing hide behind an absurdly high bar of statistical purity.
At least the blatant, and only partially disclosed conflicts of interest by Dr. Scher are being exposed publicly. What needs to be discovered is at whose behest and on whose behalf did the ‘good’ doctors conduct their campaign against Provenge approval after their position was soundly defeated in the Advisory Committee? Was Dr. Pazdur orchestrating their efforts…as many have charged? Why didn’t FDA Commissioner A.von Eschenbach intervene on behalf of these terminal patients who now face death with no effective acceptable alternative treatment? Some very astute individuals within the biotech analytical community have surmised that the FDA commissioner basically allowed himself to be blackmailed by Dr. Pazdur. Sadly…the FDA Commissioner has ‘circled the wagons’ and only immediate intervention by the courts or congress will be sufficient to get Provenge to those who desperately need it.
IMO…FDA Commissioner von Eschenbach and others have the blood of tens of thousands on their hands; the needless suffering and premature deaths of these patients will be their legacy.
This a story which begs to be researched extensively. Please keep up the great coverage.
Paul Haider
C. Payne,
Excellent comments! A+
paul1149
Ed, another great job following this very sordid tale. It was a revelation to learn that the FDA is conducting its own internal investigation into the Provenge denial. The work of outraged patient advocates is paying off. The story is becoming more widely known and momentum is building. The FDA would indeed be wise to get to the bottom of this issue themselves because we are not going away. If they don’t clean up their own shop and rectify matters, we will not rest until a congressional investigation does the job for them.
GB,
p.
jack
yes, if DNDN had done a partnership,Provenge would most likely be on the market. Everyone knew this except DNDN management and its their fault Provenge was not approved. They abandoned all reason,and chose to go it alone with execs who had and still have no idea how the fda approval process works. DNDN has wasted millions of dollars and diluted shareholder value several times instead of partnering up on provenge. Idiotic.
Because of this incompetence the pipeline including Neuvenge was shelved.
It is not too late for DNDN to learn from their mistakes and partner up on provenge and go it alone on Neuvenge,but I fear they will continue to make the same disasterous mistakes they have made for the past four years.
brentb
Thanks Jack…. the subeona’s on it’s way….
B A
Let’s get the facts straight..FDA did not fail to act. They did act..they said no! Unfortunatley that is mis-interpreted by some as failure to act. Good things take time. Be patient and let the process happen properly.