inhumane fda

Dendreon's Provenge Looks Likely to Be Approved in Mid-2010

Nice article.

Let me add something.

Dendreon filed the amended Biologics License Application (aBLA) with the FDA on October 30th. Dendreon had been rolling in the application and that was the date the full application was completed/submitted to the FDA. That means that the date by which the FDA must act is April 30, 2010. So while it is not incorrect to say that approval is expected by mid 2010 it will probably be much sooner.

The group CareToLive (CTL) has fought for expedited approval of Provenge so that men with late stage prostate cancer could begin receiving its benefits sooner. While the cold hearted FDA has turned their back on these men they did make one promise to the Citizens in their response to the CTL Petition and that was that they would expedite review of Provenge when the rest of the data was submitted by Dendreon.

Now remember, the application is an amended one that provides the additional data sought by the FDA per the Complete Response (CR) letter issued to Dendreon by the FDA in May 2007 (called Black Wednesday by Dr. Mark Thornton). The amended filing is not a new filing rather it amends the previous license request made by Dendreon in November 2006. Yes, that's no typo, I said 2006.

Note, that in October of 2008 the FDA received addditional data from an Independant Data Monitoring Compnay (IDMC) that was monitoring the Dendreon IMPACT trial. Those results were impressive and if the curves from the prior trials stayed consistent the final trial results were likley to meet the requirements set forth by the FDA in the CR. So the FDA knew again from the IDMC at the IMPACT interim peek that Provenge worked in 2008.

Point being is that it has been way too long! The FDA can approve this immunotherapy very quickly, even by December 25th 2009. It only has to want to do so. And why wouldn't it want to do so? This is after all a badly needed treatment for a late stage patient population that lacks good alternative treatments!

You are exactly right that approval day will be a big day for the patients and for the entire field of immunotherapy.....lets usher it in soon!

Johnson & Johnson Is the Latest FDA Casualty

Huang Thomas. While some oversight might be needed do you want Richard Pazdur at the FDA making the decision if you have no viable treatment options?

The FDA admittedly does not know how to properly evaluate innovative new treatments. Worse still they ignore their exper AC panels who do know how to do it.

Nobody at the top of this FDA has any humanity and nobody cares enough to do a proper risk/benefit analysis that properly reflects the risks to late stage prostate cancer patients.

That is why the FDA must listen more to advocates, less to big pharma and timely decide citizen petitions (not to mention respond to FOIA requests). The FDA works for us not big pharma. Litttle biotechs like Dendreon are threats to them, especially when they refuse to sell out to them.

Provenge wil be approved in 2010 but it is those that are missing out now that are the current victims of the inhumane FDA.

Johnson & Johnson Is the Latest FDA Casualty

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.

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

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?

Dendreon: The FDA's Commissioner Doth Protest Too Much!

Resign Andy. You have lost control of your agency.

Your FDA is unable to even respond in acccordance with Federal regulation to the CareToLive Petition within 9 months despite the fact that 83 people a day die having been denied Provenge. Sorry to bother you with that..... you are so busy with more important things.

Isn't is just quite the coincidence that the 3 no votes on effectiveness were by those that had something to lose by approval of Provenge. The fourth no vote was by the FDA biostatician that said there was a 1 in 40 chance that the Provneg results on efficacy were arrvied at by chance.

Would not want the dieing patients to risk that one in 40 chance that the treatment does not work.