Provenge Activists Fail To Get FDA Documents
21 CommentsBy Ed Silverman // December 2nd, 2008 // 9:03 am
A federal court judge has denied a bid to force the FDA to immediately make available documents involved in the controversy over the Provenge prostate-cancer vaccine. A group of cancer patients and investors in Dendreon, which is developing the vaccine, has been fighting in court to get the agency to approve Provenge, after a surprise move last year to require additional study.
In an order yesterday, US District Court Judge Gregory Frost denied a bid by the group, called Care To Live, to require the FDA to respond to a long-standing Freedom of Information Act request for documents. The agency maintained it has a long list of FOIA requests and can’t get to the Provenge matter until October, because the request is “complex” (look here). Frost essentially split the difference and ruled the FDA must reply by May (the ruling).
As with every court setback, the ruling infuriated the attorney for Care To Live, which argues each delay costs lives. “We are disappointed that, without being specific about why the CDER division of the FDA requires more than five more months to respond to a simple information request, considering so many families are affected by their inaction, they were none the less granted the additional time to respond,” attorney Kerry Donahue writes us. “The current FDA has proven itself over and over again not to be very patient friendly.”
Care To Live filed a lawsuit last year, after the FDA unexpectedly rejected the recommendation of its advisory committee. The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. A federal appeals court rejected arguments that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the vaccine. The group appealed to the US Supreme Court.
Dan A.
Published on: http://www.psa-rising.com
The Unreachable Availability of Provenge
Terminal patients are those who are not expected to live, usually due to an illness such as advanced cancer. Typically, a cancer patient is considered terminally ill if it appears he or she has 6 months or less to live. Cancer patients who are terminally ill, without cure or tolerable treatment, with the expectation that they will die soon, may seek and desire even unproven treatment options.
Understandably, for patients at a severe stage of illness, such as advanced prostate cancer, possible extension of life with comfort is worthwhile regardless of lack of evidence of proof that the treatment will indeed provide those benefits.
The FDA claims authority over the treatment options of such patients. Yet in recent years the FDA, with its frequent drug recalls and black box warnings –usually imposed only under pressure from the public — has proven itself to be rather inadequate. The FDA may not be an ideal judge of treatment options for very sick patients.
Individuals should be the deciding factor in selecting their treatment course along with their health care provider, and not an unreliable FDA.
Prostate cancer is the second most common cause of cancer death in men, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in the USA in about 30,000 deaths a year from this disease. The more aggressive and advanced prostate cancer becomes, as determined by measures such as Gleason score and methods such as bone scan, the harder it is to treat the patient.
Yet innovation still exists in medicine. A few years ago, a small biotechnology company called Dendreon was working on a conceptually new treatment for prostate cancer. They called it Provenge.
The immunotherapy method developed by Dendreon requires the removal from each diseased patient of some white blood cells (part of the immune system). These are reinjected into the donor patient after being processed by a method designed to make the cells attack a target found only on tumors — in this case a chemical called PAP, which is over-produced by prostate cancer tumors.
As developed in the race to make Provenge the first immunotherapy biologic treatment for progressed prostate cancer patients, Dendreon commenced clinical trials on patients who, no longer responding to standard available treatments, had no approved option remaining except for a chemotherapy called Taxotere. At such a traumatic stage of prostate cancer, many patients, foreseeing brutal side effects from Taxotere, refuse treatment entirely. As tested in clinical trials, Provenge requires just three injections in a period of six weeks.
Provenge received Fast Track status from the FDA because initial evidence indicated potential benefit for terminal patients. Dendreon proceeded to gathered evidence of the safety and efficacy of Provenge as a therapy of benefit for severe prostate cancer patients. Clinical trial results indicated that men with advanced prostate cancer who were treated with Provenge obtained life extension twice that of patients receiving chemotherapy, and without the concerning side effects of chemotherapy.
The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method. Patients and their families expressed great joy. Caregivers and specialists such as urologists and oncologists who treat such patients were no less elated. In March 2007, an FDA panel recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety, as demonstrated in its trials.
Now for the bad news: to great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients. They announced this rejection, due to, they said, ‘lack of data, ’ in May of 2007. This decision contradicted their own experts’ favorable opinion of Provenge weeks before delivering this terrible news. Especially on considering that the FDA Commissioner is a prostate cancer survivor himself, many found this ruling completely unbelievable.
Soon after the FDA passed this judgment, others discovered conflicts of interest. In particular, one of the oncologist’s specializing in prostate cancer who helped evaluate Provenge on behalf of the FDA agency, Dr. Howard Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by another biotech company called Novacea. This company had signed a co-promotion agreement with a major pharmaceutical company, Schering, to provide support for development of this competing therapy for advanced prostate cancer.
Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turned out, eventually, Novacea’s drug was discovered to have serious flaws, and Schering pulled out of their agreement with Novacea.
In addition, in an incident between March and May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge, claims which critics believe were without merit, speculative and even fabricated.
Overall, the FDA’s refusal to approve Provenge angered many, and a newly formed advocacy group called Care to Live last year filed a lawsuit against the FDA charging clear lack of protocol or knowledge about such complex treatment agents as Provenge.
Terminal patients, I surmise, desire comfort during the progressive disease that has placed them in the last chapter of their lives. They certainly should have a right to choose any treatment that possibly could benefit them. Most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, for these patients possible benefits clearly take priority over safety issues of unapproved treatments.
The controversy could be concluded by a terminal patient’s signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients. Considering the available data on Provenge, granting approval, especially for terminal patients, would seem completely rational.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. The FDA ultimately harmed others more by not approving Provenge- nor offering any exceptions for cancer patients in this extreme situation.
I would go as far as to say that the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. In view of the FDA’s past failures with regard to drugs belatedly taken off the market and the increasing need to label other approved drugs with black box warnings, individuals should be the deciding factor in selecting their treatment course along with their health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” — Aldous Huxley
Dan Abshear
Dan Abshear has worked since 2007 as a freelance medical writer and health care advocate and supporter with several organizations.. After training and working as a Navy and Marine Corps medic for several years, Dan worked for Tenet Healthcare, where he assisted with a group of Urologists and their duties, which included those patients with various stages of prostate cancer. From 1996 to 2006 Dan worked as a sales representative for three of the largest pharmaceutical companies in the world.
Kerry
THE NEXT FDA COMMISSIONER
It’s the Citizens that the currently unfriendly FDA are there to serve, a fact long forgotten by the current FDA. Also, TIMELY access to innovative new treatments for patients with late stage disease where there are no good alternative treatments available which was important enough to encompass within the revised FDA mission statement must be a priority. That mission was not accomplished under our current FDA chief.
The next FDA commissioner needs to remember the mission of the FDA is to protect and serve the Citizens and to speed innovative safer new treatments to them. The next commissioner should stop ignoring the pleas of the citizens! In the current FDA the Citizens have no voice and nobody at the top levels of the FDA has shown any inclination towards be caring or sensitive to patient rights.
Currently, Citizens do not have a voice in the FDA. The Citizen Petition process at the FDA is broken, as the FDA is completely unresponsive to filed Petitions. The FDA’s consideration of the opinions of patient advocates and even their own hired expert’s opinions at AC hearings are given mere lip service.
The public is given no rights, no voice and no way to express its concerns to the Agency. There is very little support left for the agency in its current decayed state. Even the staunchest of supporters such as Peter Barton Hutt, former FDA Counsel, who went before the Energy and Commerce Committee in January 2008 to ask for more funds for the agency, when current commissioner Andrew von Eschenbach would not do so as he was afraid to anger/upstage President Bush, now admits that the agency is broken. “This is a fundamentally broken agency,” Hutt stated earlier this year, “and it needs to be repaired.” Mr. Hutt has laid out some basic principles for sound government regulatory policy. They are:
1. To protect the public from harm.
2. To preserve maximum individual freedom of choice.
3. To guarantee meaningful public participation in the decision making process.
4. To promote consistent and dependable rules that are equally applicable to everyone.
5. To provide prompt decisions on all of the issues that arises in a regulatory context.
Quoting Mr. Hutt: “The third principle is an easy one-public participation. Our country was founded on the democratic principle of participation.
During the early years of government regulation this was not a central
issue because the government was not regulating very much, its
intrusiveness was not very noticeable, and therefore participation was
not sought after. But as regulation has grown and real restrictions have
affected all of us, public participation has become essential to
legitimizing the regulatory process. In my opinion, the most important
statutes Congress has enacted in the past 100 years are the Freedom of
Information Act, the Sunshine Act, and the Advisory Committee Act”.
Currently, the FDA ignores the public to the point that it is seemingly annoyed that the public dare even bother them, has made a mockery of the Advisory Committee Act, is unresponsive to Freedom of Information Act requests and has absolutely no transparency or accountability. Nobody knows how a decision to approve or deny a license is even made.
All of this is easily demonstrated by a review of the case of Provenge. In the case of Provenge, an immunotherapy for late stage prostate cancer patients, the FDA ignored its own expert advisory committee and patient advocates at the AC hearing, refuses to decide a Citizen Petition regarding Provenge filed in July 2007, has ignored a FOIA request to CDER to produce documents relative to the matter and has ignored advocates calls for approval, despite an October 2008 Independent Data Monitoring Company (IDMC) report showing increased survival and no safety concerns for Provenge.
The next FDA Commissioner needs to be someone who can understand the principles of regulatory government, be someone who knows who he works for, and one who will strive for a more transparent, accountable and citizen friendly agency.
Note: Provenge was once not approved because it missed on an endpoint of Time to Progression (TTP) by two one thousands of one percent, even though it showed survival, because survival was not the pre designated primary endpoint. Since then an IDMC said that Provenge again showed survival advantage and was safe but it was only 20% survival and not the 22% commanded by the FDA at an interim study peek. Despite a January 2008 letter from Jesse Goodman indicating that the agency was actively considering the petition to reconsider Provenge approval, the agency has since been unresponsive despite the additional evidence as recently reported by the IDMC.
Seeks the Truth
The illness of our once great nation slowly moves from one organ to another agency, much like MRSA, relentlessly smothering “wellness.”
Since mid-2007, more than 40,000 men with late stage Prostate Ca have now succumbed , many of whom would most certainly have benefitted from Provenge therapy.
The persistently obvious “cover-up” of intra-FDA agency misdeeds, blessed by the courts, continues to astound.
A notable Jewish rabbi once said..” What you do to the LEAST of them, you do unto me.”
What the forces of evil have done to the tens of thousands of “the least of them,” now known as men sufferering with terminal PCa, is unconscionable and despicable.
May God damn them all.
Greg Gilbert
One more “hidng behind a tree” situations for the FDA. Personally, I want this issue followed all the way through to the end. I want the facts brought out for the public to see. Why and who is the FDA protecting?
I know if I personally did something like this, the Feds would have me in front of a judge and jury. I guess I don’t know people in the right places.
Don’t let this issue die. Upon approval, I want ALL documents exposed and those behind the documents exposed to see the conflicts of interest. I want justice!
Gabby
Arnie
Attorney Kerry Donahue writes us. “The current FDA has proven itself over and over again not to be very patient friendly.”
The FDA is worst than any Terrorist organization because it causes the deaths of more innocents than any Terrorist organization, about 50,000 PC patients who need the vaccine ,Provenge which has proven Safe and Effective,but delayed by the FDA.
adam feuerstein
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?
I know, that may shock the charlatans and tin foil-hat wearing conspiracy junkies from Care to Live, but then, common sense and brain power isn’t their strong suit.
Case in point: Comments from people like “Arnie” who says, “The FDA is worst than any Terrorist organization because it causes the deaths of more innocents than any Terrorist organization, about 50,000 PC patients who need the vaccine Provenge which has proven Safe and Effective, but delayed by the FDA.”
What a laugh!
Tony F
SHOCKED!
Don’t know any other appropriate word to describe the continuing obfuscation by the FDA of easily retrievalable computerized documents.
I’ll make a WAG that the FDA’s attorneys already have copies of ALL the FDA FOIA requested documents and it is the liars, I mean, lawyers who don’t want this information released because I suspect it contains a smoking gun just as the FOIA documents from NIH did which showed Allison Martin’s (and NIH’s) involvement in writing Howard Scher’s anti-Provenge CONFIDENTIAL letter after the March 07 Advisory Committee meeting.
Shame on those prostituting the legal process; they’d best recognize that “change” is coming to DC in about 50 more days.
Paul
Adam,
Some critics of Provenge contend the survival benefits of Provenge aren’t robust enough to warrant FDA marketing approval. Yet, I feel these critics demean the human reality.
We know that patients who received Provenge had a 4.5 month median survival advantage than that reported for the placebo arm. Nearly twice as effective as Taxotere’s 2.3 month survival benefit. Even more impressive, where the patients that received Provenge followed by Taxotere where shown to increase their median survival to 35 months.
Yet, the survival advantages for Taxotere are enough to garner FDA marketing approval but not for Provenge? Taxotere showed a lower survival advantage and significant adverse side effects when compared to Provenge.
These barriers to reason must not stand. We must bring truth and reason to power in the public arena. The FDA uses statistics the way a drunk uses a lamp post - for support rather than for illumination.
Moonshooter
Adam, Adam, calm down; you’ll have a stroke or something!
And what kind of communication is this:
“I know, that may shock the charlatans and tin foil-hat wearing conspiracy junkies from Care to Live, but then, common sense and brain power isn’t their strong suit.”
……….from someone such as yourself with a supposedly adequate education. Remember, name calling and ridicule is reserved for the less-educated…ahem!
Steve
Wow Adam. Got a lot of time of your hands now I guess. Are you one of the unlucky smucks that Cramer laid off? Oh well, I’ll just answer your whack job on CTL with one statement of fact. Provenge proved a 20% increase in survival over the standard of care at an interim look in a Phase III trial. Even you would have to agree that is very impressive if you could drop your hatred for all things DNDN. If you can have a nice day. JERK.
David Lanzet
Adam
How do you look yourself in the mirror? Are you aware that 50,000 men have now died a painful death with prostate cancer, since not getting approval? Did you watch Boston Legal yesterday? It was about denial of a drug to treat alzeimer. Could not get the drug. Only recourse is to die. If you live long enough it is likely that somewhere down the road you will use Provenge. The odds are high that either you, your family, or a friend will if they live long enough get PC. Can’t help but feel you totally lack empathy. Don’t forget the ac vote was 17 to zero Provenge was safe. 13 to 4 that it was effective. The fda in the past almost never went against the rec of the ac. What hedge funds are you protecting? Evidently money is more important than a LIFE.
cordial
Ted Girgus
Adam Feuerstein wants to tell the public he knows more than the EXPERT PANEL appointed by the FDA to review the data on Provenge. I will remind Adam that these doctors, scientists, researchers, statisticians,(not journalists) voted 17-0 on safety and 13-4 that it showed SUBSTANTIAL EFFICACY.
As an advanced prostate cancer patient seeking Provenge to extend my life, I wish Adam good health and may he never be in my position.
grr
Adam,
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.
Meg
I am not familiar with the fight over Provenge and I guess if it would give my loved one 4.5 months more of life, I would want it approved, too. Hence the passion.
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.
Doc
The additional life expectancy with DNDN’s product seems longer than many other oncology therapies that offer a few extra months of life and often cost thousands of dollars per month.
The interim analysis beside, FDA advisory members that work for competeing companies should not have a place on such committees.
Tanin
I agree with Adam here,
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.
Jason
Adam has been on the fence several times on Dendreon. First he valued the company at $25 per share and then said panel will vote no. Only later after AC he said the there was a 80 percent chance of approval. May 9th 2007 a great injustice was servered. 2009 will be the year of revenge for Dendreon. Enjoyed the call Cramer made sell the day before the stock went up 300% and they buy at 17. He has always been wrong on Dendreon. Looking forward to 09.
Kerry
Meg, we appreciate your comments and welcome you to the world of Provenge. The FDA is very friendly with big pharmaceutical companies. They get freebies from them every week. They get wined and dined at hotels by these companies every month. These companies by way of PDUFA fees even pay the FDA directly.
However, not all new drug applications come from big pharma. Other’s such as a small biotech called Dendreon who is the maker of Provenge, also apply for licenses from the FDA. Dendreon has spent 100’s of millions of dollars and over 10 years working with trials to show that Provenge is safe and effective. They have now proven that it is safe and effective except to a few statisticians or conflicted hooligans in the FDA who believe the proof of its 33% (three year survival benefit) may have been arrived at by mere chance and the odds of that happening were 1 in 40. So since there is only a 39 out of 40 chance Provenge works the FDA uses that as a reason to deny approval to this late stage class of patients.
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.
Tony F
Meg,
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
Meg
Thank you for the information about Provenge. Unfortunately, I have a different fight and unfortunately I have testified before the FDA numerous times. Imagine how it feels to have a son killed by Lilly’s blockbuster Zyprexa and an agency that is in bed with all the companies that make atypical antipsychotics. The people killed that I know of- from Zyprexa - were only sons in their TWENTIES AND THIRTIES who, if not on this lethal drug, might well have lived a full life. I do not belittle your cause, but I can tell you from personal experience that not one pharma executive has ever gone to jail for death, dismemberment, lifetime chronic illness caused by a drug. Never. And I cannot remember once ever being looked in the eye while testifying before the FDA.
They know their guilt. And many of those with any conscience at all have left. Drug safety at the FDA is a joke.
kyoto27
Adam,
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?