Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

Editor's note: several of the links following are to PDF documents.

On June 2, 2008, the United States Court of Appeals for the Sixth Circuit, Cincinnati, Ohio, granted CareToLive oral argument in Appeal No. 07-4465, regarding the Southern District of Ohio Court’s decision (case # 07-729).  The case is scheduled to be heard on July 29, 2008, before a three-judge panel.  The granting of oral argument is just the next installment of a saga that began on May 8, 2007, with the FDA’s issuance of a Complete Response Letter (“Approvable Letter”) to Dendreon in the matter of its Provenge immunotherapy for end stage prostate cancer. 

Soon thereafter, CareToLive filed a Citizen Petition, requesting that the FDA reconsider its failure to approve Provenge. This action was followed by the filing of a complaint against Dr. Andrew von Eschenbach, the FDA Commissioner; Hon. Mike Leavitt, Secretary of the U.S. Department of Health and Human Services; Dr. Richard Pazdur, and FDA employee; and Dr. Howard Scher, a Special Government Employee of the FDA.  Among other things, the complaint asked the Court to: 

A) Enjoin the FDA from denying the marketing and sale of Provenge to androgen-independent prostate cancer patients. 

B) In accordance with established United States Common Law, Plaintiffs seek to enjoin the Defendants from denying immediate access to Provenge and ask that all Defendants collectively and individually be restrained and ordered to cease and desist their interference with Dendreon’s lawful attempts to provide aid to dying patients by marketing and distributing Provenge. 

C) A declaration that the FDA’s failure to approve Provenge was due to the failure of the FDA to follow its own regulations combined with the improper actions taken by Dr. Howard Scher, and Dr Richard Pazdur that improperly corrupted the process and influenced the decision not to approve Provenge on May 15th 2007.

See the entire document here. 

In the exchanges that followed between the CareToLive counsel, Kerry M. Donahue, Esq., and the Department of Justice [DOJ] lawyers representing the defendants, a repeated point of conflict has been the unwillingness of the FDA to release information requested by CareToLive under the Freedom of Information Act [ACT]. Here is but one example of Mr. Donahue’s response to the FDA FOIA’s office unwillingness to comply with U.S. law, following a recitation of assertions made by CareToLive involving the actions of the defendants in this matter:

Defendants assert that the Plaintiffs have no evidence of the facts asserted but nowhere do they say that the allegations are not the truth. At this point in the proceedings all allegations must be taken as true, therefore the contention of Defendants in that regard is not relevant during this stage of the proceedings. In addition, the Defendants have taken extraordinary steps to deny access to the evidence. Not only has the FDA refused to provide documents to Plaintiffs which were demanded under the Freedom of Information Act but they requested that other witnesses not talk to Plaintiffs and not provide documents to Plaintiffs. 

The Plaintiff made two FOIA requests. One to the FDA, for which no documents have yet been provided…and one to the National Institute of Health [NIH] which has been recently responded to. That response and the documents provided are attached hereto as “Exhibit A”. The document appears to be a (v3) “third version” of the Scher “leaked” cancer letter. Accompanying e-mails and the other versions were not provided to Plaintiffs by the author of version three, which author was Alison Martin, a current employee of the National Cancer Institute [NCI] and a former employee of the FDA.

In January 2008, the following complaint was filed by CareToLive in the matter of the FDA’s refusal to comply with the FOIA request.

The [Center for Drug Evaluation and Research] CDER division, as well as the Commissioner’s office has not been forthcoming with easily accessible documents and appear to be stonewalling for reasons that may include the fact that three members of Congress have called for a Congressional hearing of the underlying matter, for which the FOIA request, if properly responded to, might provide evidence helpful to that investigation of the underlying wrongful actions of the FDA.

Even today, the FDA persists in playing “hide and seek” with the documents sought by CareToLive, most of which comprise the relevant papers of Dr. Richard Pazdur. 

This certainly isn’t the first time that a Federal agency has attempted to stonewall attempts by the public to obtain information regarding their inner workings and the processes they use in making decisions.  But a recent decision by the US Court of Appeals for the District of Columbia Circuit on April 25, 2008 should put the FDA on notice that the courts may not be too happy with Federal agencies that play with the law. 

In the case cited above, the agency involved is the Federal Communications Commission [FCC] and the issue pertains to broadband over power lines [BPL].  The technology has been pushed by the FCC for some years as being necessary for those who desire Internet access but who can not access and/or afford service through the telephone lines, DSL, cable, or satellite.

Basically, the technology sends wideband Internet signals over the power line to the subscriber’s computer.  One of the major problems encountered when deploying this technology, however, is the fact that power lines carrying broadband signals of the type used for Internet communications radiate signals over a broad portion of the radio frequency spectrum, among them being frequencies used by Radio Amateurs and other users of the high frequency (or so-called “shortwave”) portion of the spectrum.  This includes shortwave broadcasters, the international airlines, and even the military. 

The American Radio Relay League [ARRL], the largest national Amateur Radio organization in the U.S., petitioned the court to review the FCC's orders adopting rules governing broadband over power line implementations. The crux of the problem lay in the assertion by the ARRL that the FCC had failed to comply with the Administrative Procedure Act [APA] by not fully disclosing for public comment the staff studies on which it relied. Writing for the three-judge panel of Circuit Judges Rogers, Tatel and Kavanaugh, Judge Rogers summarized the Court’s findings as follows:

The Commission failed to satisfy the notice and comment requirements of the Administrative Procedure Act (‘APA’) by redacting studies on which it relied in promulgating the rule and failed to provide a reasoned explanation for its choice of the extrapolation factor for measuring Access BPL emissions. [emphasis added] 

That the FCC violated the APA hinges on case law. Said the Court:

It would appear to be a fairly obvious proposition that studies upon which an agency relies in promulgating a rule must be made available during the rulemaking in order to afford interested persons meaningful notice and an opportunity for comment.

Further, the Court added:

Where, as here, an agency’s determination ‘is based upon “a complex mix of controversial and uncommented upon data and calculations,"' there is no APA precedent allowing an agency to cherry-pick a study on which it has chosen to rely in part.

Even more damning was the Court’s conclusion in the matter:

[N]o precedent sanctions such a 'hide and seek' application of the APA's notice and comment requirements.

The case involving the FDA’s refusal to turn over documents requested by CareToLive under FOIA and the matter pertaining to the FCC’s game of hiding data from the public that did not favor its position on BPL address two entirely different issues.  However, the case involving the FCC and BPL technology serves to demonstrate that even the Federal government is not immune from feeling the sting of the U.S. Court system when an agency attempts to thwart the intent of the law.  In the case of the FDA’s withholding information legally sought under the Freedom of Information Act, the issue is made all the more egregious by the fact that the DOJ has been defending the agency against CareToLive’s challenge of the agency’s stonewalling. 

It will be interesting to see what the United States Court of Appeals for the Sixth Circuit thinks about the FDA’s game of hide and seek in CTL’s case. 

Disclosure: Author has owned shares of Dendreon since 2006

 

Comments

[Jose Mcintryre]

I'm tired of whining Dendreon shareholders.

[Tony F]

Jose... hope you don't get PCa... you have 2 options currently... do nothing and die or take chemotherapy, suffer horrendous side effects including a 2% chance the chemo will kill you, have a very poor Quality of life and then you'll die... at least, Provenge has been adjudged safe (17-0) and effective (13-4) by the FDA's Advisory Committee.

And, remember, part of the medical treatment for terminal prostate cancer victims includes castration and administration of female hormones because the cancer feeds off androgen.. i.e. testerone.. at least for a while.

As to Dr. Cohen's article, another documented and concise report on the continuing stone-walling by our FDA and, in this case, stone-walling against terminal prostate cancer victims. These men are dying at the rate of 83 per day (or some 30,000 per year)--an unconscieneable action.

Regarding Dr. Howard Isadore Scher of Sloan Kettering in NYC and his involvement in the denial of Provenge to terminal cancer patients, he certified to the FDA--in order to sit in judgment of Provenge at the FDA Advisory Committee meeting--that he had only 3 Conflict of Interests.

Internet research has found 17 possible COI for Scher. These 17 COI have been reported to the FDA Investigative Office and the Health and Human Services Investigation division without having any investigation done by either department to date.

Note, in particular, items #1 and #17 in the list of Scher's alleged COI!

1. NOVACEA:
… Grants & Research support;
… STUDY CHAIR of DN-101, Asentar-since HALTED as ineffective
… a 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, Scientific Advisory Board

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 (March 6, 2007; since removed , 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.


Thank You, Dr. Cohen, for your well-spoken article!

[The User]

Sorry, but the data are pretty uncompelling--the vaccine doesn't enhance survival in a statistically significant way. That's been the standard used by FDA for years. It's not just this vaccine. So, Tony, whine away, but the facts simply don't support having to have my tax dollars go to purchase this product for men with prostate cancer, since the data don't suggest it prolongs survival. Period. Next!

[in4thelonghaul]

Outstanding effort to right a terrible wrong. The FDA is a totally corrupt organization which has escaped proper oversight and accountability for many many years. Thank God that some group has finally stood up and is at least exposing them.

PCa patients are suffering and dying needlessly while a far safer and proven superior treatment is sidelined for years by these fools at the FDA. I honestly think the term "wicked" is one which most aptly describes these government scum.

They have stolen hope and life itself. These FDA officials are criminals of the worst sort and should, in truth, be brought up on criminal charges.

[inhumane fda]

The Pharm

You are right, the FDA said there is a 1 in 40 chance that the survival evidence was reached by pure chance. You would not want to waste your tax dollars on a 39/40 chance that you extend the life of a dying man. Heck you could use that money to put gas in your SUV or your boat!

Even the FDA has not yet given a reason why Provenge did not receive conditional approval, which would have allowed these men access while the IMPACT trial continued. Go ahead call and ask them. They won't tell you just like they have not told the other 100 people who have asked.

Why has the FDA hidden docuements. Why does the FDA refuse to answer a patient petition filed over 10 months ago? Why, becasue one angry man (Dr. Pazdur) due to his anger, ambition and lack of compassion, had the ability that the FDA seemingly allows to sabotage a BLA to serve his own agenda.

Von E is to weak of a commissioner do deal with the likes of Dr. Pazdur.

Provenge deserved proper due process. Something they have yet to receive. You can argue all you want about whether Provenge should have been approved or not (even though the FDA has admitted it lacks the scientific ability to evaluate new drugs such as Provenge yet ignores its own hand picked experts) but the real issue is the lack of due process it's BLA received. Would you like your fate put soley in the hands of Richard Pazdur?

[User 209103]

"The Pharmaco..."

Statistics? What ignorance! What arrogance!

Who the hell are you to tell a dying man that 4+ months is nothing?

Let me guess - you work at the FDA right?

What a complete disgusting sleeze you are.

[Steve from Missouri]

1. If Provenge does not enhance survival, why did it get a 13-4 vote for being effective? Are the experts on the FDA committee idiots?

2. The effectiveness of Provenge is not really the point. The FDA is not complying with the law and our tax dollars are being spent to defend them in court. I'd rather see those tax dollars spent on Provenge. What is the FDA trying to hide? Why don't they just release the information.

3. Provenge is safe and they are trying to get permission to give it to patients who are going to die very soon. Where is the risk of approving it with the requirement that the results be tracked? What is the FDA afraid of?

Generally, when there are unanswered questions of this type, you will find a money trail that leads to the truth. Time will tell. Perhaps the truth will set Provenge free.

[kyoto27]

The Pharmaco Man said:

“Sorry, but the data are pretty uncompelling--the vaccine doesn't enhance survival in a statistically significant way.”

Pharmaco needs to go back to school:


He asserts that the D9901 study did not attain statistical significance for survival when the final data was released in October 2004. This is an incorrect assertion. The overall survival p value was 0.01, easily beating the p=0.05 threshold. This goes to the crux of the anger of the Provenge advocates. Statistical significance on survival is the "gold standard" by which the FDA judges all oncology treatments, and Provenge met it with flying colors in the 9901 trial.

In addition, the p value for the primary endpoint of cancer progression was p=0.052, barely missing the p=0.050 threshold. For Howard Scher and Maha Hussain, this narrow miss was blown up to be an utter failure. They said that because the p value did not reach 0.050, then all additional data (including survival) should be discarded. Basically, their position was that because the odds of being successful in progression were only 94.8% and not 95.0%, there was no correlation between the two metrics and the 99.0% survival odds should be thrown in the trash.

So Pharma Man, the data does suggest it prolongs survival. And the data also suggests our FDA’s decision to de-rail Provenge had nothing to do with good science and a lot do with politics and money. Period. Next?

[phil_vardena]

The FDA chose not to approve Provenge, even though it was advised (on March 29, 2007) by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
Among the NOs, Dr. Sher and Dr. Hussain.

Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.

Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?

Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.

On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?

We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.

[phil_vardena]

Do you remember Imclone?

Sam Waksal's daughter had sold 2.5 million dollars worth of ImClone shares on December 27, 2001, the day before the announcement and subsequent stock decline.

The next day, there were rumors that Martha Stewart may also have sold in advance of the news, thanks to a direct tip from her friend, Sam Waksal.

On June 9, the Wall Street Journal says that Harlan Waksal knew three days in advance that the FDA would reject the Erbitux application.

Later, it would become clear that Alan Bennett, a lawyer for Bristol-Myers in Washington, had sent an email to Harlan Waksal and Bristol-Myers management saying that Richard Pazdur, an FDA employee, told him the Erbitux application would be rejected the following Friday, which turned out to be the case.

On June 12, Sam Waksal was arrested by the FBI on insider trading charges.

Martha Stewart was arrested and served prison time.

Dr. Richard Pazdur is still at the FDA…

[phil_vardena]

One last comment.

Probably the most important point is that we know Provenge is aimed at end-stage, dying prostate cancer patients. These people do not have choices.
If you want, please repeat with me: these people do not have choices - and are going to die anyway.

Provenge has been voted safe! 17-0! Even the conflicted doctors voted it is safe!
What's the downside of giving Provenge to the dying?

The British now have hospitals where experimentation can be used on patients who request it. As I understand it, it can go beyond what's being tried in the clinic, it can go to treatment that Doctors and Patients agree to. The advantage of such a program is that anecdotal data can be gotten on different uses of drugs which if effective can result in additional trials to see if the results can be duplicated.

The FDA is not permitting such experimental work, even for those willing to try it and also willing to sign off all legal claims against those treating them. I'm not suggesting that drugs untried in people be used experimentally first, but after they're proven safe in a Phase I and have advanced to Phase II they should be made available as long as documentation's provided on how they're to be used, and why they've been selected for the specific application.

I strongly believe that the USA fail to equal or exceed acts like what the British are doing it won't be long before they're no longer a world leader in drug development. The FDA's been driving up the cost of US approval, while extending time to approval tremendously; this might be fine to determine a headache medicine is completely safe, but it's not fine for a drug designed to benefit the victims of terminal diseases like cancer. It's time to take Approvable out of the FDA vocabulary, especially if people are dying waiting for the drug. An approval with any number of conditions that must be met is fine, as long as it still means that people who need it can get it after the approval.

[hpski]

Let's pretend for awhile that there's no emotional component to the Provenge issue. FDA's approval of what I believe is a 'breakthrough" advance in the treatment of mCRC, Erbitux, was based upon the drug given as monotherapy + BSC (best supportive care) to EGFR-expressing patients who had failed prior Irinotecan & Oxaliplatin based therapy, vs BSC alone. Overall survival was increased by 34%. Median overall survival in months was 6.14 in the Erbitux group vs. 4.57 months in the BSC group. Erbitux combined with Irinotecan resulted in a median time to disease progression of 4.1 months vs. 1.5 months using Erbitux alone. The objective lesson here is that a lot of hard work and science goes into developing new technologies that provide an incremental benefit. Approval gets the drug on the street, giving doctors and their patients an additional tool, and some very important "intangibles"... e.g. greater "control" over their battle against the disease, and hope. Now Erbitux is being evaluated in head & neck, as well as NSCL cancer. Certainly it was easier to recruit study sites as well as patients to participate, since the drug was already approved. There are myriad other examples/precedents of oncology associated meds being approved on bare threads of data. I submit that a Federal Court would not allow the case cited above to proceed had, in addition to the COI issues, FDA's ruling on Provenge been even semi-consistent with previous (incremental) data driven decisions. There is definitely something hiding under a rock at FDA - the same FDA that allows drugs indicated for a specific condition, e.g. ERD due to neuropathy, peripheral vascular disease, to be marketed on TV as a recreational drug. The same FDA that allows Prilosec to go "OTC" when self treatment for occasional GERD with h2 antgonists like Zantac or generic Pepsid working as well, while NOT inhibiting protein absorption or causing increased gastrin dumping, which long term, increases colon cancer risk, which brings me right back Erbitux.....

[Jose Mcintryre]

Tony F, first of all, you can claim its about humanity all you want but its money dndn shareholders really care about. Its pretty simple, if the upcoming dndn data is good enough for approval, then yes, the fda will have proven to be too cautious. If the trial fails, then dndn shareholders will be proven wrong and provenge simply isn't particularly effective. Instead of this constant complaining and crying foul, lets see if provenge works in this trial, which I don't think is the foregone conclusion shareholders take as a given.

[Frankie62]

Jose, I'm sorry but I agree with the previous writer who replied to you. Pray you don't get prostate cancer. Those men who have been diagnosed know that they have few choices - remove the prostate if they are lucky enough to have caught it early as my husband did, burn it out with xrays either by external means or by the "seed" technique and/or chemo"therapy&quo... All of those choices for "treatment" make the cure as bad as the disease. No man wants that, so many go without treatment and accept impending death. If the Provenge immunological treatment consists of having blood withdrawn, treated, then reinfused 2-3 times, with virtually no side affects, the choice is a no-brainer. It is morally reprehensible to bar those grown men from that choice if there is even a slight chance it could work. Give them the information and let them make the choice. The FDA panel ruled that it was effective and safe. If it is you, your brother, your uncle, your dad, your grandfather or your son, what choice would you make?

[Jake Blues]

I am long DNDN and it has been sinking lately. I would love to see frequent articles from this author because I'm really unsure what to do with it at this point.

[quiact]

The Unavailability of Provenge and the Disappointment of Those With Deadly Prostate Cancer

*FDA’s mission statement: To promote and protect public health

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness presently. Since such patients will likely die in a short period of time, treatment options, even if they are not entirely unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. Reform has to start somewhere at some time.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men. Furthermore, out of all cancer types more are dying from prostate cancer now than other cancer diagnoses.
For those unaware, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, 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.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams

Dan Abshear

Author’s note: What has been written is based upon information and belief

[Ames Tiedeman]

DNDN had some buyers last week. Will this continue?

[quiact]

I have been a phyician's assistant to a group of urologists who treated prostate cancer and have no affiliation or knowledge of Dendreon, in response to my earlier post, which is why I wrote what I did.

Don't narrow your mind.