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.
November 23rd, 2007 | Posted by Kerry DonahueBy: Kerry M. Donahue, Counsel for CareToLive, a not for profit corporation.
Now that we have enjoyed our Turkey Day it is time for me to get back to work for CareToLive.
When CareToLive requested I investigate and look into the Provenge debacle back in May 2007 and consider filing a law suit against the FDA we talked about what we wanted to accomplish.
Over the course of the following two months, as we investigated and researched the potential litigation, we decided that we needed to do three things.
1) Bring attention to the travesty that occurred at the FDA so that the world will know and demand change at the FDA.
2) Seek Congressional investigation and hearings.
3) Initiate litigation, that if not successful would at least help both of the other goals.
While those at CareToLive organized rallies, helped organize a letter campaign to Congress, advertised in the Washington Post, initiated litigation, ran out bus ads, lobbied Congress and fought like hell……..Congress remained asleep at the wheel.
While Congress awakens from its hibernation, the litigation will go on. This litigation is far from over. We merely move to a new arena.
Now we will be in the Sixth Circuit Court of Appeals in Cincinnati, Ohio. Here we will have a three judge panel who will review this matter “de novo”. That means “in its entirety”.
As Martin Luther King Jr. and those that fought so hard for their civil rights in the 60’s and 70’s would tell you, the hardest thing to change is the way people think. Unfortunately, our litigation depended on being able to get the lower court (since we are appealing, the District Court will now be the “lower court”) to change the way it thinks. The court refused to treat terminal cancer patients any differently and decided the proper course was to say that the patients cannot sue the FDA for violating their constitutional rights unless the government says it’s okay. There is some bad case law that lends some support to this idea. We knew that if the lower court tried to quantify and categorize this case and not see it for the special and unique circumstance that it is, that we would be in a struggle. Let’s hope we can get a different analysis and thought process from our new three Judge Panel.
Unfortunately we have begun the 21st century with Courts who have been quicker to take away civil rights then to broaden them. Our founding fathers would be appalled if they heard a court say that terminal patients have no right to sue the FDA for arbitrary and capricious conduct that affects their health and well being.
To make something unprecedented happen takes a change in thought process. It takes an awakening. Many of you have been awakened and that is just how we must awaken the Court, the Congress and the World. To change someone’s thought process takes more then just a singular action. Almost all effort at government reform has taken more then one law suit or one march. Most of those great moments in our history (where thought was changed in government) started with small grass roots movements such as ours. Our struggle will continue just as those have.
It would not have been enough for Martin Luther King Jr. to have just filed a law suit. The court would have found plenty of precedent to rule against their fight for civil rights.
Meanwhile Congress remains asleep at the wheel.
The lower court actually did us a favor. They went too far and made what the Sixth Circuit will find to be pretty clear error. By deciding the ripeness issue the way the court did the Sixth Circuit may be quick to over rule. The affect of the “non-approval” of Provenge is absolutely no different then if they denied Provenge. The result is the same. The Court has never even seen the CR letter! The Court also clearly committed error when it said that the AIPC patients suffer no more harm then any other patient waiting for treatment approval. As we have been saying this case is different. Provenge is for AIPC patients; their terminal condition is DIFFERENT. In addition you have the experts 17-0 and 13-4 saying the treatment is safe and effective. Again the Court chose not to see the differences but chose to lump Provenge in with medicines such as those sold off the back of a horse drawn wagon.
When a person is denied the exercise of constitutional rights, they are as meaningless to him as the shadow of a ghost.
Why are Courts of this century looking to take back our civil rights, fought so hard for by our founding fathers and strengthened by others since then.
Meanwhile Congress remains asleep at the wheel.
The Notice of Appeal will be filed next week. I believe I can get a tight briefing schedule from the sixth circuit case manager that could put the decision in that Courts hands within 60 days.
Also, CTL has been told by the FDA Freedom of Information Act Office (FOIA) that the office of OOD (Richard Pazur) and the Commsioner (von Eschenbach) of the FDA, is to have a response to our FOIA request that we believe should provide additional evidence for us by sometime in the next week. If we do not receive the full FOIA responses we seek we shall file a separate legal complaint in the same court seeking to enforce our FOIA rights, in the coming weeks.
CTL is also researching and consulting with myself and other counsel looking into the idea to file further individual claims in the home states of Dr. Pazdur and Dr. Scher, against those individuals.
CareToLive will keep fighting to the Supreme Court if need be. It is clear now that total government reform is needed. The task may be bigger then originally anticipated but it can still be done. Where are we headed if our government is left unchecked and allowed to violate the constitutional rights of the very people they are sworn to protect.
Meanwhile Congress remains asleep at the wheel.
This is no time to stop our advocacy efforts. Its time to triple them! Lets all continue to fight. CTL, along with their counsel have not yet begun to fight.
Regards, Kerry
Popularity: 92%
November 23rd, 2007 at 1:34 pm
Hi Kerry,
Just want you to know that you are a hero to a lot of people who you have never met.
We are all over this world and we are strengthened by your tenacity.
We applaud your passion and will.
Stay strong my friend, because soon people like me and all the other AIPC patients will rise up and you will have an Army of Millions.
Your biggest fan,
Teddyboy
November 23rd, 2007 at 6:38 pm
Dude, if you want people on your side, give us some info on the drug.
November 23rd, 2007 at 6:44 pm
http://caretolive.com/videos/
Let the videos speak for them self.
November 23rd, 2007 at 6:52 pm
[…] Read the whole article… This entry was posted on Friday, November 23rd, 2007 at 10:13 pm and is filed under le Chat Marchet. 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. […]
November 23rd, 2007 at 7:32 pm
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November 23rd, 2007 at 7:48 pm
I am sorry to hear you have discovered the FDA and govt don’t care. That is also what I wrote about on my website years ago, linked on this comment. It is not news. It’s just that it happens to each person individually and most people don’t think about it until it’s them in trouble.
November 23rd, 2007 at 8:29 pm
You had me at the FDA is uncaring. Why bring MLK & civil rights into an argument about health & prostate cancer?
November 23rd, 2007 at 8:41 pm
[…] read more | digg story […]
November 23rd, 2007 at 9:21 pm
Aaron, we have a wealth of information about Provenge and immunotherapy. Provenge went through over 10 years of trials. It works and it’s safe. It is up to us to get this approved. Big money wants to keep the chemo machine oiled. Cut, Zap and if that doesn’t kill you, they will prescribe other toxic medicines to counter the effects of the toxic treatments. Wall streeters have been buying hospitals. Is it any wonder. Nice steady government money. And lots of it. When there are no other alternatives, we have to accept that. However these cretins at the FDA tried to stop a safe and effective immunotherapy. They don’t want any competition. The FDA is run by people who do not have our health at interest. Look at some of the drugs they have approved. We can all make a difference. Stick around. We have just begun this fight. We are going to be putting out a wealth of information out there. Visit the Dendreon website too. Those of us who have been following this story for years, realize the potential. We couldn’t pretend we didn’t see it. We will not go away.
November 24th, 2007 at 3:18 am
Shame on the FDA
[…]The FDA has decided that terminally ill prostate cancer sufferers will just two alternatives; chemotherapy and death. An alternative that the FDA decided not to approve is Provenge, the first-of-a-kind vaccine that can prolong the lives of men wit…
November 24th, 2007 at 7:29 am
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November 24th, 2007 at 10:27 am
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November 24th, 2007 at 10:38 am
It is very easy to see who the REAL so called TERRORIST are in this messed up world. The US Government runs all over the world screaming they are fighting Terrorism. When in all truth they “the US Government” is the biggest Terrorist of them all. All one has to do is to pick any agency within the Government, FDA, SEC, DOJ or even the President himself. The US Government is responsible for more deaths than any so called Terrorist. The FDA for their ties to Big Pharma and special interest and their internal COI’s. The FDA is the Best MONEY can BUY! Greed & Corruption are Number # 1.The SEC responsible for more American jobs and health insurance losses than any other entity, by NOT enforcing the Counterfeiting of Stock Shares also known as NSS. The SEC has been asleep at the wheel for so long that they have forgotten what is even right anymore. Very soon when the debt level rises above 12 Trillion Dollars all politicians can take credit for bankrupting this Country. The only thing needed then will be more prisons for everyone will be doing whatever they can just to put food on the table for their families. May God have mercy on us all.
November 24th, 2007 at 11:08 am
This article is very weak; where is the information? Learn to write with focus, instead of whining, if you want to spread the word.
November 24th, 2007 at 11:28 am
S,
In some ways you are correct. We are just cutting our teeth in the blog world. Stick around. More blogs are coming with lots more informaion. In the meantime please visit our Videos, Articles, Research, Story, etc. pages. We are here to answer your questions too. This is such an important topic. Immunotherapy will open the door for other cancers to be treated this way too.
November 24th, 2007 at 4:25 pm
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November 25th, 2007 at 12:43 pm
This is just a the first step in getting big business and the US Government back in the hands of the citizens. We all need to stand up and be counted. Way to go Kerry!
November 25th, 2007 at 8:05 pm
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….
November 25th, 2007 at 8:40 pm
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?
November 25th, 2007 at 9:17 pm
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.
November 25th, 2007 at 10:37 pm
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.
November 26th, 2007 at 11:34 am
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!!
November 26th, 2007 at 11:49 am
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.
November 27th, 2007 at 1:26 pm
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???
November 27th, 2007 at 2:57 pm
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?
November 27th, 2007 at 11:17 pm
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?
December 1st, 2007 at 4:23 pm
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.
March 30th, 2009 at 12:02 pm
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