Judge Dismisses Most Of The Provenge Lawsuit
11 CommentsBy Ed Silverman // November 23rd, 2007 // 9:13 am
A federal judge has tossed a big chunk of a lawsuit filed by Care To Live, a non-profit group that’s fighting to get the FDA to reverse a surprise decision last spring to delay approval of a Dendreon’s Provenge prostate cancer vaccine. The agency action amounted to an about face following an advisory committee recommendation that Provenge be cleared for marketing. However, two dissenting panel members later wrote FDA officials urging a go-slow approach, setting off a firestorm over agency procedures amid accusations of undisclosed financial conflicts of interest among the dissenters.
In making his ruling, US District Court Judge Gregory Frost refers to jurisdiction (see below), but primarily cites the issue of ripeness, a reference to the fact that the FDA hasn’t yet decided whether to approve Provenge. “Because the Provenge BLA (biologics license application) administrative process is ongoing, the FDA may ultimately approve the application, which would render Plaintiff’s claims moot,” he writes in his 21-page order.
Lawyers for the federal government “correctly contend that (Care To Live) faces no greater hardship from waiting for a final agency decision before bringing suit than the patients who might potentially benefit from many other biologics or drugs intended to treat life-threatening conditions that are under review by the FDA at any given time. Indeed, Congress balanced such hardships against the risks and dangers of using unsafe and ineffective drugs when it set the statutory standards for approval of drugs and biologics.
The FDA delay, “at most, potentially prevents access to an unproven and speculative future benefit. Moreover, immediate consideration of the administrative record by this court could not speed patients’ access to Provenge, because the only remedy that this court could issue is a remand to the FDA to continue its review of Dendreon’s BLA.”
The ruling infuriated cancer patients who argue that delay equals death. “The argument that it is not ripe because the FDA has not yet made a decision is totally unreasonable…
“So does the court mean that the FDA can avoid review by never making a decision on anything?” fumes Kerry Donahue, Care To Live’s attorney, in an e-mail. He adds that he is waiting a ruling on the remaining claims and, if necessary, is poised to file an appeal.
Donahue is referring to charges that two people acted to delay Provenge outside the scope of their official capacity. One is dissenting panel member Howard Scher, a noted oncologist at Memorial Sloan-Kettering Cancer Center, who Care To Live alleges failed to disclose financial conflicts of interest. The other is Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs and allegedly orchestrated the letter-writing campaign to FDA officials as part of a Byzantine political power play.
As to jurisdiction, Frost notes that, essentially, one can’t sue the government unles the government says you can, or at least under limited circumstances. Donahue writes us that “this case involved cancer patients suing the FDA for violating their constitutional rights. We hoped the court might recognize that the patients should have the right to sue a government agency that is purposely (or at least recklessly) violating their constitutional rights particularly considering that the FDA is sworn to protect their rights.”
Chris
Despite all of the controversy surrounding delays, dissent, failure to reveal COIs, plaintiff lawsuits etc the data still don’t appear to support efficacy claims for Provenge. Safety yes, but drugs are not aproved for being safe. For cancer drugs above all regulators have a greater tolerance for impaired safety if efficacy is proven but Provenge doesn’t seem to have demonstrated it.
MyPharmalotID
Ah, Chris…the following 13 (of 17) members of the Provenge Advisory Committee (AC) held on March 29, 2007, voted “yes†on the second question, asserting that, indeed, Provenge demonstrated substantial evidence of efficacy, the Congressionally mandated FDA standard. What part of “efficacy†do you not understand? Do you believe that you are more learned than any one of the FDA specialists listed below?
AC Chair
James J. Mulé, Ph.D.
Associate Center Director
Applied Science and Technology Development
Michael McGillicuddy Endowed Chair
Melanoma Research and Treatment
H. Lee Moffitt Cancer Center and Research Institute
12902 Magnolia Drive, SRB-2
Tampa, Florida 33612
Richard B. Alexander, M.D.
Professor of Surgery
Chief of Urology Service
Baltimore Veterans Affairs Medical Center
10 N Greene St #6D152
Baltimore, MD 21201
Matthew J. Allen, Vet. M.B., Ph.D.
Associate Professor
Department of Orthopedic Surgery
SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
Michéle P. Calos, Ph.D.
Associate Professor of Genetics
Department of Genetics
Stanford University School of Medicine
300 Pasteur Drive, Room 334
Stanford, California 94305-5120
Jeffrey S. Chamberlain, Ph.D.
Professor
Departments Neurology, Medicine and Biochemistry
Health Sciences Center
University of Washington School of Medicine
1959 N.E. Pacific Street
Seattle, Washington 98195-7720
Steven M. Dubinett, M.D.
Professor of Medicine
Director, UCLA Lung Cancer Research Program
Division of Pulmonary, Critical Care Medicine,
and Hospitalists
David Geffen School of Medicine at UCLA
37-131 Center for Health Sciences
10833 Le Conte Avenue
Los Angeles, CA 90095-1690
Farshid Guilak, Ph.D.
Laszlo Ormandy Professor of Orthopedic Surgery
Orthopedic Research Laboratories
Duke University Medical Center
MSRB Room 375, Box 3093
Durham, North Carolina 27710
Larry W. Kwak, M.D., Ph.D.
Chairman
Department of Lymphoma/Myeloma
University of Texas
M.D. Anderson Cancer Center
1515 Holcombe Boulevard – Unit 429
Houston, Texas 77030
Francesco Marincola, M.D.,
Director of the Immunogenetics Laboratory
in the Department of Transfusion Medicine
Clinical Center of the National Institutes of Health
Bethesda, MD
Robert J. Samuels
Florida Prostate Cancer Network
Tampa, FL 33615
Doris A. Taylor, Ph.D.
Medtronic Bakken Professor
Center for Cardiovascular Repair
University of Minnesota
7-105A NHH
312 Church Street SE
Minneapolis, Minnesota 55455
Sharon F. Terry, M.S.
President and CEO
Genetic Alliance Organization
Suite 404
4301 Connecticut Avenue, NW
Washington, DC 20008-2369
William W. Tomford, M.D.
Professor of Orthopedic Surgery
Harvard Medical School
Massachusetts General Hospital
55 Fruit Street
Boston, Massachusetts 02114
MyPharmalotID
Reposted with permission:
Letter from Kerry Donahue on CTL website
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 Donahue
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By: 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 novoâ€. That means “in its entiretyâ€.
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 courtâ€) 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 bad case law lends some supports to this idea. We knew that if he 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 arbitrarily 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 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 buggy.
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 Courts obviously believe this is a congressional matter. However, Congress is to busy out lobbying and looking for campaign contributions, to help cancer patients.
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 Pazdur) and the Commissioner (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
Matt
Chris -
Way to think inside of the box. It is exactly this type of thinking that is the direct reason over 16,000 people have died since Provenge was delayed.
You should go hang out with Pazdur and Scher for Thanksgiving. Nothing makes me more disgusted than thinking about those who are directly responsible for delaying Provenge sitting around with their families on Thanksgiving while over 16,000 families sit down with one less loved one at the table. The sad thing is, most of these 16,000 would have been at the Thanksgiving table had it not been for these monsters.
Chris, perhaps your eyes won’t be opened until someone you love is in the position that men with advanced prostate cancer are in. And even then, you may be too obtuse to ever get it.
R.A.S. MD
The court now joins the list of weak-willed opponents perfectly willing to deny a survival advantage to PCa victims. Judge Frost had the rare opportunity to move in favor of a new, fresh look at the PCa/Provenge story but chose instead the easy way out.
The ruling of lack of “ripeness” of the case since the FDA “might” approve PV down the road is particularly galling.
PCa victims now must choose between Scylla and Charybdis
while the FDA fiddles and immunotherapy burns.
A highly regarded panel of EXPERTS voted 17-0 for safety and 13-4 for SUBSTANTIAL evidence of efficacy for ProVenge.
There is absolutely NO reason why conditional approval for PV was not granted.
The Federal Court now joins the growing list of spineless
characters who have put their own interests ahead of tens of thousands of dying men.
This is the most shameful story I have ecountered in many, many years.
Chris
Hello PharmalotID - Of course I’m not arrogant enough to consider myself more learned than the panel. One of the panel is a personal friend so no, I would not pretend to know better. I read the data, it didn’t meet its endpoints, the lead statistician said the same.
And Matt - please don’t presume to comment on the extent to which cancer has affected my loved ones. You will never know and it really is irrelevant to what ought to be an objective discussion. Now that is obtuse.
Thurly
Chris,
The submission wasn’t based on the primary endpoints, it was based on survival. When members of the advisory committee asked the FDA what it wanted from the committee since survival couldn’t be evaluated biostatistically (no remaining alpha with which to look at the data), the FDA said it wanted their judgement. The survival data clearly impressed the FDA team that evaluated Provenge — look at the briefing docs — and it clearly impressed the advisory committee…
Unimpressed were the Pazdurites who believe approval should only be based on 500-1000 person double-blind PIII trials. The Pazdurites won the day. The question is, should they have?
In my opinion, this is a political question, and, according to an informal MSNBC poll, some 93-94% of the American people believe that victims of terminal disease who have run out of FDA approved options should have access to promising new, but not yet approved therapies.
The biostaticians may be right about what the biostatistics say and do not say. But they are not and never were the ones who were supposed to decide where to set the approval bar. That bar has been set by Congress. The FDA is supposed to follow the congressional guidelines for approval.
Those guidelines are: is the drug safe? The advisory committee voted 17-0 that it was. Does it show substantial evidence of efficacy? The advisory committee voted 13-4 that it did.
Provenge should have been approved.
Thurly
Tom Smith
What I want to know is, has the DOJ investigated Scher’s COI’s mainly (Novacia/Proquest) yet???? If they have done so, is their findings available through Freedom of Information ACT??? I want this SOB investigate by SEC,DOJ, 60 mins etc!!!
Tom Smith
Chris, Wake up! cover your short position and think about the ~16,500 men that have died since 5/9/07. Its your kind of thinking that 80,000 plus died because of Pazdur’s delaying approval of Erbitux! How do can these people at the FDA sleep at night is beyond me!
Kerry Donahue
Chris
The statistician you speak of found that there was a one in forty chance that the evidence of the effectiveness of Provenge was by mere chance (the fda likes 1/1600, whether its a toe cream or a treatemnt for terminal patients).
AIPC patients would take a 39 out of 40 chance that it helps them live longer helathier lives.
This is demonstrative of the moronic way of thinking at the FDA.
If you really know one of the courageous 13 you need to let them explain it to you so that you understand.
Dawn Floyd
The government is controlled by the drug companies and the drug companies would lose too many millions of dollars if an effective prevention of cancer were to be unleashed. You think Cancer Centers want a cure for cancer? They’d be out of business.