Here it is June 11 and my frustration with the Prostate Cancer Community continues to climb.
On May 31, I wrote that the FDA had compromised over the issue of the approval of Provenge. At that time, it was announced that the FDA would be willing to use the interim results of Dendreon’s current, on going, clinical trial in their evaluation of Provenge.
This would mean if the results support Provence’s efficacy the treatment might receive approval by 2008. This willingness to use the interim data would cut the approval process by at least 2 years. This is not ideal, as the immediate approval of Provenge is what the Prostate Cancer Community needs. However, given the reality of the current circumstances, this is the best we will get from the FDA.
This loosening of the requirements by the FDA does not mean that the community should stop the pressure and the protests. We need to let the FDA know that we speak with one, strong voice in our support for the development and approval of new treatments, including Provenge. We all know the current lack of available and approved treatments for men with advanced prostate cancer is both abysmal and disgraceful.
What is surprising to me is the unwillingness within our own Prostate Cancer Community to apply any pressure of any nature, on the biotech industry. We should be screaming to Dendreon to supply us with a Compassionate Use Program while we wait for the approval of Provenge.
I asked that Dendreon step up to the plate in my May 31 post and again I ask that they do the ethical thing and provide us with a Compassionate Use Program.
I also wonder why the leadership of the prostate cancer community, our advocacy groups and our physicians, has not joined the call to convince Dendreon to extend lives now and provide a necessary Compassionate Use Program.
If this were the breast cancer community things would be different. What is wrong with our community and our advocacy groups? Why are not we making as much noise about this issue as we made when we stood against the FDA’s decision.
Our mantra should be “Provenge Now and Compassionate Care Nowâ€
Joel T Nowak MA, MSW
How on earth would Dendreon afford giving out Provenge? First, look at its long-suffering stock chart. Then look at the massive cutbacks it just did ( one third the company, I believe) in order to stay alive while the FDA satisfies its compulsive need for idiosyncratic statistical purity. Now consider that the company just took on more senior debt in order to insure being able to make it to the end zone with Provenge, as long as it occurs no later than early ’09.
It was Maha Hussain, one of those on the FDA’s advisory committee who was adamantly opposed to provenge (and who also required a conflict of interest waiver in order to serve on the committee), who repeatedly called for Dendreon to provide Provenge free of charge. She might as well have been calling for it to go out of business, and most likely she knowingly was.
There’s also the aspect that giving away the drug would make enrollment in the ongoing clinical trial that the FDA is requiring almost impossible. What terminal cancer patient would chance getting placebo when the real drug was available free?
It’s a lot more complicated than you’ve made it out to be, thanks to authoritarian elements within the FDA and the byzantine statistical hurdles they erect against therapies that don’t fit their mold.
The real culprit here is the FDA, and specifically its CDER/ODAC branch. Commissioner von Eschenbach has dismally, spectacularly, and tragically failed to manifest his “bridge, not a barrier” vision of the agency. It’s business as usual in Rockville, Maryland, and the conflicts of interest in this case are staggering.
This is a scandal of immense proportions. The Vioxx’s get all the attention, but 30,000-60,000 men will die silently of prostate cancer while the FDA fiddles regarding Provenge. Our best chance now is not to expect Dendreon to give out what it cannot afford (though I probably would welcome any public attention drawn to the Provenge story), but for Congress (especially at the start of an election campaign) to call the FDA brass on the carpet and demand a full accounting to the men dying of prostate cancer.
Develop creative ways to help pharmaceutical companies do more expanded access and compassionate use without
putting the burden on the companies. This could save thousands of lives a year.
If there ever is a case to apply this principle, I think Provenge is it. Any idea what “creative ways” might exist for getting Dendreon to go along with a compassionate use program?
I think one easy way to apply the principle is “conditional approval” with conditions that mimic what would be expected of a compassionate use program in terms of patient population. It gets the drug out to people who fit a given criteria (say, end-stage disease), but takes the burden of providing it for free off the company. Of course, the FDA already had that option available to them and declined to use it.
Joel, I agree 110% regarding this statement:
“If this were the breast cancer community things would be different. What is wrong with our community and our advocacy groups? Why are not we making as much noise about this issue as we made when we stood against the FDA’s decision.”