Comments on: The FDA is uncaring, the world won’t change their thought process and meanwhile Congress remains asleep at the wheel, when it comes to Provenge for the terminally ill. http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/ CareToLive | Help Men With Late Stage Prostate Cancer | Provenge Now! Thu, 04 Dec 2008 22:31:44 +0000 http://wordpress.org/?v=2.3.1 By: Angel http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-75 Angel Sat, 01 Dec 2007 23:23:33 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-75 My father who is a young man has gotten progressively worse health wise and I feel his medication that he has been on for years is the cause. What recourse do I have and what steps should I take to fight on his behalf? I am already seeking alternative treatment options but I want to pursue this legally. I am also a nursing student who is leaning more toward the holistic aspect of nursing. All we are taught is how to shove medication down people's throats and to spend most of our time charting and not providing the patient care people need. My father who is a young man has gotten progressively worse health wise and I feel his medication that he has been on for years is the cause. What recourse do I have and what steps should I take to fight on his behalf? I am already seeking alternative treatment options but I want to pursue this legally. I am also a nursing student who is leaning more toward the holistic aspect of nursing. All we are taught is how to shove medication down people’s throats and to spend most of our time charting and not providing the patient care people need.

]]> By: Dan in San Diego http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-70 Dan in San Diego Wed, 28 Nov 2007 06:17:45 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-70 What gives the FDA the right to let me die of cancer? Discovered three years ago I have explored all my prostate cancer options and my choice is a vaccine, which has now been denied by the FDA. My life is in your hands. How can you sleep at night? What gives the FDA the right to let me die of cancer? Discovered three years ago I have explored all my prostate cancer options and my choice is a vaccine, which has now been denied by the FDA. My life is in your hands. How can you sleep at night?

]]> By: chat noir http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-68 chat noir Tue, 27 Nov 2007 21:57:09 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-68 Was the vote for efficacy 14 - 3? Or was it 13 -4? Can't seem to get your "facts" straight, Mr. Donahue? I don't claim to be "smarter" than the advisory panel "experts." In fact, I do believe Provenge is efficacious and safe...and will be approved. I think it would have been approved in May had the 500 enrollment been complete at that time. But no....that didn't happen. Why? Prostate cancer patients didn't enroll in a trial when they thought approval was imminent. Why risk getting a placebo when approval is right around the corner? So the FDA asked that DNDN complete the enrollment. So who really caused the delay, Mr. Donahue? Was the vote for efficacy 14 - 3? Or was it 13 -4? Can’t seem to get your “facts” straight, Mr. Donahue? I don’t claim to be “smarter” than the advisory panel “experts.” In fact, I do believe Provenge is efficacious and safe…and will be approved. I think it would have been approved in May had the 500 enrollment been complete at that time. But no….that didn’t happen. Why? Prostate cancer patients didn’t enroll in a trial when they thought approval was imminent. Why risk getting a placebo when approval is right around the corner? So the FDA asked that DNDN complete the enrollment. So who really caused the delay, Mr. Donahue?

]]> By: Kerry Donahue http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-67 Kerry Donahue Tue, 27 Nov 2007 20:26:06 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-67 Efficacy was established as set forth by Congress. 17 experts were brought in by the FDA and all but the "experts" who had major conflcits of interests that went into the advisory comittee hearing with an agenda to sabotage Provenge, said there was substantila evidence of efficacy. Why are you smarter then 14 experts??? Efficacy was established as set forth by Congress. 17 experts were brought in by the FDA and all but the “experts” who had major conflcits of interests that went into the advisory comittee hearing with an agenda to sabotage Provenge, said there was substantila evidence of efficacy. Why are you smarter then 14 experts???

]]> By: chat noir http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-66 chat noir Mon, 26 Nov 2007 18:49:22 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-66 Take it to the next level, Kerry, but until you build your case on FACTS instead of wild assumptions...you really don't have a case. Grandstanding will get you nothing (except a few solicited DIGGS). Provenge will be approved when ALL the data is submitted to the FDA and when the data fully supports efficacy. And there's nothing this ill-fated lawsuit (or Congress) can do to facilitate this approval. Take it to the next level, Kerry, but until you build your case on FACTS instead of wild assumptions…you really don’t have a case. Grandstanding will get you nothing (except a few solicited DIGGS).

Provenge will be approved when ALL the data is submitted to the FDA and when the data fully supports efficacy. And there’s nothing this ill-fated lawsuit (or Congress) can do to facilitate this approval.

]]> By: eswauger http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-65 eswauger Mon, 26 Nov 2007 18:34:20 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-65 In the USA 30,000 Men a year die a horrible death, while promising technologies sit unused while the onocologists fight the urologists over who gets the money--shameful. The FDA is complicit in this crime against humanity. It's time for some serious house cleaning. I'm mad as hell and I'm not going to take it anymore!! In the USA 30,000 Men a year die a horrible death, while promising technologies sit unused while the onocologists fight the urologists over who gets the money–shameful. The FDA is complicit in this crime against humanity. It’s time for some serious house cleaning. I’m mad as hell and I’m not going to take it anymore!!

]]> By: chat noir http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-59 chat noir Mon, 26 Nov 2007 05:37:29 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-59 Is Kerry independently wealthy? Does he have any cases other than the one for CTL? Judging (no pun intended) by his poor writing skills, I'm convinced that he is no more an attorney than my cat is a Mensa member. Is Kerry independently wealthy? Does he have any cases other than the one for CTL? Judging (no pun intended) by his poor writing skills, I’m convinced that he is no more an attorney than my cat is a Mensa member.

]]> By: Rory Kearney http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-58 Rory Kearney Mon, 26 Nov 2007 04:17:23 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-58 Sorry anon. I didn't mean to give you a negative digg. I clicked the wrong button. Rufus put a post on the IV board that may answer your questions. You will have to go there since there are about 10 links embedded in the document which do not show up here. I also put a document on the research page today with Dr. Schers undisclosed conflicts of interest which somebody had researched. http://www1.investorvillage.com/smbd.asp?mb=971&mn=165714&pt=msg&mid=3523332 Formal Dispute Resolution and the FDA No wonder the company didn't protest the approvable letter. After you see what happened in this example your realize it's a waste of time. From Eye On FDA: November 23, 2007 Formal Dispute Resolution and the FDA - Revisiting the Issue Given the holiday week, there is no Weekly Roundup this week, but my eye did catch an interesting tidbit that made me want to re-visit the issue of appealing an FDA decision. I last wrote about it on July 17 and since then, there is more evidence that Formal Dispute Resolutions (FDR) are probably not the most productive pathway to approval. This week, the FDA issued a letter to Labopharm in which it announced that the appeal the company made to overturn an earlier agency decision to issue approvable letter for analgesic once-daily tramadol. It wasn't the first approvable letter issued, but the second for the product. The company apparently is going to carry on its pursuit to overturn the approvable letter, according to a press release. I stand by my earlier posting on the Formal Dispute Resolution. If you would like to review it, the FDA has a Guidance on Formal Dispute Resolution. On August 6, Encysive Pharmaceuticals filed an FDR with the FDA. On September 5, they got a response from the FDA denying the appeal. The company issued a statement. "We continue to believe that the issue raised by the FDA was sufficiently addressed in the NDA and we are reviewing the FDA's response with external experts to determine the next step forward," said George Cole, President and Chief Executive Officer of Encysive. Whatever that means. Then, a few weeks later on September 24, the company issued a press release announcing new Phase III trials for their product. "Encysive believes it had successfully addressed all of the questions raised by the U.S. FDA in its New Drug Application (NDA) for Thelin in PAH. However, the Company has concluded after consulting with external experts that the best path forward for commercializing Thelin in the U.S. is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA." Let's do a little risk/benefit analysis here about FDRs. * Benefit? The only benefit is that the FDA would decide that it was wrong and that the company was right and that the agency doesn't really need further information. This would be in spite of two approvable letters. And, remember, the appeal is being made to the agency that made the decision. Also, I don't know of a single successful appeal. So the benefit, if it is there, is not likely. * Risk? Well, in addition to being turned away from approval by two approvable letter, the image of the product suffers further when each appeal is denied. From a communications perspective, unsuccessful appeals do little to build strong branding for the product. In addition, one creates media milestones for each and every rejection by the FDA. In short, while appeals to the agency in the face of multiple approvable letters - an increasing happenstance this year at FDA - might be tempting for the sake of some outlet where the company can insist that a it is right about its product being appropriate for approval, it probably does little to promote the chances that the product will see the market any sooner than if one went ahead and met the conditions outlined in the approvable letter, as set out by the FDA. Encysive could tell you that. Sorry anon. I didn’t mean to give you a negative digg. I clicked the wrong button.

Rufus put a post on the IV board that may answer your questions. You will have to go there since there are about 10 links embedded in the document which do not show up here.

I also put a document on the research page today with Dr. Schers undisclosed conflicts of interest which somebody had researched.

http://www1.investorvillage.com/smbd.asp?mb=971&mn=165714&pt=msg&mid=3523332

Formal Dispute Resolution and the FDA
No wonder the company didn’t protest the approvable letter. After you see what happened in this example your realize it’s a waste of time. From Eye On FDA:

November 23, 2007
Formal Dispute Resolution and the FDA - Revisiting the Issue

Given the holiday week, there is no Weekly Roundup this week, but my eye did catch an interesting tidbit that made me want to re-visit the issue of appealing an FDA decision. I last wrote about it on July 17 and since then, there is more evidence that Formal Dispute Resolutions (FDR) are probably not the most productive pathway to approval.

This week, the FDA issued a letter to Labopharm in which it announced that the appeal the company made to overturn an earlier agency decision to issue approvable letter for analgesic once-daily tramadol. It wasn’t the first approvable letter issued, but the second for the product.

The company apparently is going to carry on its pursuit to overturn the approvable letter, according to a press release. I stand by my earlier posting on the Formal Dispute Resolution. If you would like to review it, the FDA has a Guidance on Formal Dispute Resolution.

On August 6, Encysive Pharmaceuticals filed an FDR with the FDA. On September 5, they got a response from the FDA denying the appeal. The company issued a statement. “We continue to believe that the issue raised by the FDA was sufficiently addressed in the NDA and we are reviewing the FDA’s response with external experts to determine the next step forward,” said George Cole, President and Chief Executive Officer of Encysive. Whatever that means. Then, a few weeks later on September 24, the company issued a press release announcing new Phase III trials for their product.

“Encysive believes it had successfully addressed all of the questions raised by the U.S. FDA in its New Drug Application (NDA) for Thelin in PAH. However, the Company has concluded after consulting with external experts that the best path forward for commercializing Thelin in the U.S. is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA.”

Let’s do a little risk/benefit analysis here about FDRs.

* Benefit? The only benefit is that the FDA would decide that it was wrong and that the company was right and that the agency doesn’t really need further information. This would be in spite of two approvable letters. And, remember, the appeal is being made to the agency that made the decision. Also, I don’t know of a single successful appeal. So the benefit, if it is there, is not likely.
* Risk? Well, in addition to being turned away from approval by two approvable letter, the image of the product suffers further when each appeal is denied. From a communications perspective, unsuccessful appeals do little to build strong branding for the product. In addition, one creates media milestones for each and every rejection by the FDA.

In short, while appeals to the agency in the face of multiple approvable letters - an increasing happenstance this year at FDA - might be tempting for the sake of some outlet where the company can insist that a it is right about its product being appropriate for approval, it probably does little to promote the chances that the product will see the market any sooner than if one went ahead and met the conditions outlined in the approvable letter, as set out by the FDA. Encysive could tell you that.

]]> By: Anonymous http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-57 Anonymous Mon, 26 Nov 2007 03:40:53 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-57 Without discovery, it will never be clear whether or not the conflicted members of the fda played by the rules and what financial or poltical gain was achieved by these individuals. Apparently the judge feels the fda has not rendered its final decision so he is allowing theFDA process to continue. Even if there were conflicts. is it unreasonable for the fda to ask for more data? Why didnt the company file an appeal with the fda? Without discovery, it will never be clear whether or not the conflicted members of the fda played by the rules and what financial or poltical gain was achieved by these individuals. Apparently the judge feels the fda has not rendered its final decision so he is allowing theFDA process to continue. Even if there were conflicts. is it unreasonable for the fda to ask for more data? Why didnt the company file an appeal with the fda?

]]> By: Steve B. RPh http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-56 Steve B. RPh Mon, 26 Nov 2007 03:05:20 +0000 http://caretolive.com/2007-11-23/the-fda-is-uncaring-the-world-won%e2%80%99t-change-their-thought-process-and-meanwhile-congress-remains-asleep-at-the-wheel-when-it-comes-to-provenge-for-the-terminally-ill/#comment-56 Kerry, Keep up the fight..The FDA was wrong...AC committee overwhelmingly voted for approval...these men are dying..with only 1 other treatment available this is a travesty. There are 4 approved drugs for erectile dysfunction..what a joke the FDA is...Thanks Kerry and CaretoLIve for all you have done.... Kerry,
Keep up the fight..The FDA was wrong…AC committee overwhelmingly voted for approval…these men are dying..with only 1 other treatment available this is a travesty. There are 4 approved drugs for erectile dysfunction..what a joke the FDA is…Thanks Kerry and CaretoLIve for all you have done….

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