The real story—the tragedy in this case, and the one yet to be told by the so-called “Mainstream Media”—is the story of the needless three-year delay in availability of Dendreon’s Provenge for our sons, fathers, and grandfathers.

The Dendreon Investor Village (IV) message board at www.investorvillage.com(link) is where a group of the most well-informed people in the world on all-things-Dendreon, exchange information. Many have posted there non-stop since early in the decade. One daily post entitled “Daily Death Count”, documents the number of men who have died of prostate cancer since “Black Wednesday” (link to Mark Thornton op ed), May 8, 2007, the date the FDA went against the recommendation of its own Advisory Committee and refused to approve Provenge. As of this past Thursday, the date Provenge received final approval, the death count stood at 90,055. Every one of these 90,055 men were deeply loved and now dearly missed by their families and friends.

It’s difficult to ignore the fact that the March 29, 2007 Provenge Advisory Committee voted unanimously (17-0) that the drug is SAFE, or the fact that the same Committee voted minutes later, (13-4) that the drug “demonstrated substantial evidence of efficacy,” the federally mandated standard in such reviews. But the FDA did. The FDA also ignored the fact that the treatment was being submitted to help men with end stage prostate cancer, the stage for which there is no viable treatment option. Provenge would have been their last resort.

What can one say about an agency which is charged with overseeing the health and welfare of the American Public yet turns its back on men who have no hope without the approval of this drug.

The real story, the one that still needs to be exposed and understood, lies hidden within a  Washington bureaucracy that seemingly thinks it can operate without transparency, accountability, or oversight. They have rebuffed CareToLive’s attempts to unveil the secrecy that surrounded the decision making process in 2007.

Only upon critical review in the light of day can the process be corrected.

FDA is government at its worst. They operate in a vacuum. The Provenge delay has exposed the agency for just what it is. An agency that is totally disconnected from the needs of the citizens it is supposed to serve.

The real story is that the FDA is a dinosaur. It now is totally and irrevocably out of sync with its environment. In fact, the agency often acts at cross purposes with its constituency. Time and science have passed it by.

Think where we would be if Provenge had been approved three years ago. Dendreon’s Neuvenge, delayed for two years, would be well on its way now toward treating breast cancer along with two other drugs which use their cassette technology in trials. Others would have been pursuing immunotherapeutic vaccines as well, with both the government’s National Cancer Institute (NCI) and industry pushing ahead aggressively.

Despite former FDA Commissioner Dr. von Eschenbach’s famous “Bridge” speech in February 2007, which was to have set his agency on a new course in the treatment of cancer, the agency has instead squandered the very thing cancer sufferers have little of: time. If we factor in how funding and the momentum have now slipped due to the recession, the agency has set back the development of immunotherapeutics by considerably more than three years.

The real story is that it is time to overhaul the FDA. The agency must be rebuilt from the ground up. Since FDA is unable to reinvent itself through the actions of a visionary commissioner (and apparently that person is still in the wings), change must be imposed from the outside. That action can only occur in a timely way if Congress properly investigates the three year delay in approving Provenge.

First and foremost the FDA’s priorities must be realigned to serve the needs of the Public. The agency is supposed to be both the gatekeeper of the Public Health and a bridge, not a barrier, to innovation and new treatments for late stage patients, something which they appear to have lost sight of.

The FDA in its current form, will go down in the annals of history as a government health care agency hung up on statistical rigidity, entrenched in egregious conflicts of interests, and unable to use common sense to properly balance the needs of patients, or properly address human suffering. It is an agency that appears to have effortlessly ignored the pleas of the huddled masses.

Mostly we resent any notion on the part of the agency that we are unable to make any of our own life decisions. Frankly, given the attitudes reflected by the FDA towards the American Public over the last decade, one can only conclude that they view us merely as patients and advocates, and as such, nothing but a “nuisance” to them. Their persistence in treating the Public as too uninformed and too dumb to decide what’s good for them has got to end.

This indifference to “We the People” can not, must not, and will not stand.

In light of the recent FDA approval of Provenge, the media, having largely ignored CareToLive’s pleas over the last three years, has a duty to tell the real story. CTL, along with our friends at the Abigail Alliance and other advocates, have been proven right in the contentions it made years ago, to wit; that Provenge is safe and that it works. The patients should have had access to it since 2007.

The real story of the struggle against the incorrect decision to delay Provenge for three years, and of the continued refusal of the FDA to be either accountable or transparent on this issue, needs to be corrected . . . NOW!

The FDA does not appear to be even slightly remorseful. Until the FDA is publicly made to admit the error of its ways, along with being publicly admonished for those errors, there is no moving forward on the road to redemption.

How else can we bring the FDA to learn from this American Tragedy, a tragedy that they not only created themselves, but maintained at all cost for three long years and over 90,055 deaths?

A good starting point on the road to redemption would be for the FDA to admit their mistakes at the post-Advisory Committee Provenge 2007 review process. These mistakes led to the destruction of the process that was due Provenge, and the eventual early death of so many men who were literally begging for Provenge.

CareToLive members and their faithful friends demonstrated across the country including the largest demonstration outside the then FDA Commissioner Andrew von Eschenbach’s office, begging him for mercy for the men.

Mercy denied!

What is clear is that Andrew von Eschenbach, as FDA Commissioner, had the absolute authority to undo the wrongs. Despite the knowledge that he had regarding the irregularities in the Provenge approval process in 2007, and despite hundreds of letters and pleas, and demonstrations by the men at his door, Andy was too busy listening to misguided “friends” who were giving him bad advice, rather than fulfilling his mission as Commissioner of the FDA. Dr. von Eschenbach should have listened to CareToLive instead of his conflicted “friends” with their own selfish agendas.

For almost three long years:

CareToLive sought answers and an explanation from the FDA — REFUSED!

CareToLive sought transparency from the FDA — REFUSED!

CareToLive filed a formal Citizen Petition with the FDA asking that the FDA reconsider its mistaken decision of denying men Provenge — REFUSED!

CareToLive filed a lawsuit against the FDA to try to bring Provenge to the men sooner — FDA used 15 attorneys to fight it tooth and nail!

CareToLive filed a second lawsuit against the FDA — Pending in 6th Circuit, but opposed by FDA.

In the interim, CareToLive reminded FDA on a weekly basis that men are dying every day.

Tough luck, said FDA.

“Frustration” understates the way CTL felt knowing that Dr. von Eschenbach had the power to fix a bad decision by the FDA. Dr. von Eschenbach had the added benefit, when assessing the propriety of an early reconsideration of the delay of Provenge approval, of seeing the mounting evidence produced over the two years following “Black Wednesday” at the FDA, namely, that Provenge works, and that the delay was all about a process that was broken. At CareToLive we always believed that no human being could ignore these men knowing what von Eschenbach knew. We soon found out how wrong we were.

While Dr. Von Eschenbach and friends stood idly by and watched, in 2008 an Independent Data Monitoring Committee (IDMC) confirmed that the interim results of the then-ongoing Provenge IMPACT trial showed additional evidence of efficacy. Still the FDA continued to ignore not only the science but the pleas of the sons, fathers, and grandfathers.

The FDA had many chances to learn from its mistake in denying men Provenge. In fact, over the last three years, some new rules have been enacted at the FDA, put in place to assure that the Provenge problems will not occur again. This is as a close to an admission of a broken system as we are likely going to obtain voluntarily

Despite the initial missteps in the handling of the first Provenge BLA by FDA’s CBER division who began with an ill advised invitation to oncologists at CDER to “assist” them, the division personnel promised CareToLive that they would review Dendreon’s new amended application “expeditiously”. That was the least they could do considering the three years of needless delay.

CBER’s promise of expediency turned out to be lip service only, as they used the entire 6 month review period minus 1 day, to finally complete their review and approval of Provenge on April 29th. This was after all, an AMENDED Biologics License Application for late stage cancer patients for which they had much of the data for the past 3-1/3 years already, and for which they had ALL of the final clinical portions of (final phase III IMPACT trial data) since mid 2009. The IMPACT trial undeniably gave the FDA the additional data they claimed they needed in 2007. The FDA pointed out that despite the fact that they received the application on a rolling basis that they wouldn’t start their review until it was all in, so they just sat on the clinical data. This is just one more example of this bureaucracy refusing to acknowledge even in 2009, that speed was critically important, as this was no ordinary license application.

The Media needs to report the real story about the needless delay of Provenge. Only then will the somnolent Congress awaken and take an interest in investigating the delay.

Only when Congress shines their light on, and/or the Office of Investigator General (OIG) at the Securities and Exchange Commission (SEC) properly completes their investigation, will the FDA finally be forced to accept responsibility for this tragedy and truly begin its reform. It’s a shame that they have never demonstrated an ability to critically review themselves.

CareToLive thanks our members and friends for their continuing loyalty and support. We are proud to have fought side by side with you against the broken and dysfunctional FDA. We will continue to fight for reform by exposing the broken process.

We sleep a little better each night knowing that there already are some new rules in place. For example, some changes have been made concerning conflicts of interest for participants on Advisory Committees. However this is just scratching the surface. The reinvention of the FDA needs to continue at an ever accelerating pace.

The real story is that the FDA still needs major overhauling. Although the final approval of Provenge is to be widely celebrated as a game changer and a major victory in the war on cancer, our work is far from done. We must stay diligent if we are to better the agency and help propel it into the organization that it was created to be.

The real story is that this is not the end of the story.

Popularity: 50%

Tags: , Andrew Von Eschenbach, Care To Live, CareToLive, CBER, CDER, Dendreon, FDA, Kerry M. Donahue, Prostate Cancer, provenge

This entry was posted on Monday, May 3rd, 2010 at 2:45 am and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.