Sleepless in Asentar
November 15th, 2007 | Posted by CTLOn a night in early April, 2007, the temperature was hanging around 35 degrees outside. It was considered good sleeping weather on the East Coast. But a particular doctor could not sleep. He tossed. He turned. His mind was still rapidly busy with the activities from a few days ago.
He could still see his fellow panelists sitting around the table in that hotel room in Gaithersburg, Maryland. He tried his best to influence them, to show them the flaws in the medical treatment they were evaluating. He kept pointing them to trial design problems, failed endpoints, and survival that surely could not have come from the agent.
Then the doctor’s gut suddenly felt that guilt-wrenching churn. Novacea and ProQuest had just popped into his head. If those panelists persuade the FDA to approve Provenge, he is finished. “Oh, no,” he thought, “and Schering-Plough will back out of that deal. I have to do something.”
Dr. Howard Scher sprang out of bed and headed to another room.
He booted up his laptop and sat down to write a letter to the FDA. Little did he know Alison Martin from the National Cancer Institute was already working on a similar letter on his behalf. Or did he know?
“Dear FDA,” Dr. Scher began to write. “I am writing to express my concerns…”
Yes, Dr. Howard Scher was having a nightmare. He was too worried and too tightly wrapped. After all, his whole house of cards could fall down very soon. He is leading a trial that he thinks may be a more effective treatment alternative for prostate cancer. He alluded to it when he testified at the FDA Advisory Committee hearing, “So I say well, what if we think that this [Provenge] really should be available, start thinking about the number of agents that are currently under development.”
Why did all of this make Dr. Scher lose some sleep? Well, his decision making and advice had other people’s money on the line. Novacea reported on March 26th, 2007 that it spent a lot of money on R&D and it could be attributed to Dr. Scher’s Phase III clinical trial for Asentar. Novacea released this in an 8K filing to the SEC three days before Dr. Scher was to sit on the FDA’s Advisory Panel for Provenge.
And, Dr. Scher advises ProQuest Investments. ProQuest obviously took his advice because they invested in Novacea.
So with all this money on the line and after Provenge received a nice endorsement from an FDA appointed advisory panel, Dr. Scher was having a nightmare. The dollar demons in his bedroom were keeping him awake. They compelled him to do something.
On April 13th, The Cancer Letter, a non-peer medical publication “leaked” Dr. Scher/Alison Martin’s letter on the internet for all the world to see. Other news outlets started to cover it. Word was spreading.
Meanwhile, on the West Coast, biostatistician Dr. Thomas Fleming from the University of Washington, Seattle, saw Dr. Scher/Alison Martin’s letter. He decided to weigh in on the Provenge debate. He, too, wrote a letter to the FDA. Who asked him to? And if he was allowed to weigh in, why weren’t other doctors allowed to weigh in.
Dr. Fleming mentions in his letter that he lost sleep, too. But how did he know Dr. Scher couldn’t sleep? Did they discuss this?
“In a letter to FDA “leaked” in the April 13, 2007, Cancer Letter, Howard Scher of Memorial Sloan-Kettering Cancer Center presented valid and compelling arguments that FDA await the completion of an ongoing 500 patient (9902B) Phase 3 trial before deciding whether to approve Sipuluecel-T in prostate cancer patients. Reportedly, Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives. He also struggled with what he might communicate to patients about Sipuluecel-T’s safety and efficacy when discussing therapeutic options with them.
“I also was kept awake the night following the panel. I had been invited by FDA to be screened to serve on the March 29, 2007, FDA Advisory Committee, but declined because I had had limited interactions with the sponsor in the capacity of critiquing available data. Now that the FDA Clinical and Statistical Briefing Documents are in the public domain, I am at liberty to express my own serious concerns about some of the significant flaws and limitations in the 9901 and 9902A clinical trials evaluating Sipuluecel-T in prostate cancer patients.”
So Dr. Scher said he was worried, “patients may well forego more effective treatment alternatives.” This is similar to what he said at the Advisory Committee hearing.
The FDA decided Dr. Scher was right and delayed approving Provenge. Twenty-one days later, Schering-Plough gave Novacea almost $500 million. This helped with Dr. Scher’s clinical trial. He is going to have 900 to 1200 patients to toy with.
Now skip ahead seven months. Novacea had to stop the Asentar trial; too many men were dying. How do Dr. Scher and Dr. Fleming sleep now? Asentar just killed a bunch of men with something Dr. Scher thought would be more effective than Provenge. And, he kept countless others off of Provenge in the meantime. For SIX MONTHS, men with late stage prostate cancer sat around in pain and angst while Dr. Scher tested his hypothesis. For SIX MONTHS, men with late stage prostate cancer sat around and watched their cancer grow.
And for Dr. Fleming to endorse this, to say he too was kept awake at night, tells us all we need to know about him. He had the nerve to interfere with the proper processing of a BLA. This shows Dr. Fleming isn’t too smart either. How are you sleeping now, Dr. Fleming?
For the FDA to go with the minority panelists and slap science in the face with their patented, “We based our decision on science,” just shows how misguided this agency is. Science is about hypotheses, trial and error, testing, and the drive to a solution. Even Dr. Scher will tell them that. It is not perfect or etched in stone. For Dr. Scher to complain about 127 men in a trial when his trial design has 900, shows there are more variables to consider than the number of patients. Neither Dr. Scher nor Dr. Fleming nor the FDA have all the scientific, statistical or any other answers. They definitely lost on this one. They should all now be Sleepless in Asentar.
So is this an accurate portrayal of what happened? What do you think?
http://www.prnewswire.com/mnr/caretolive/30529/
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Tags: 90 Nassau Street, Alain Schreiber, Alison Martin, Asentar, Ashok Batra, Binkley, Brachytherapy, cancer, Care To Live, CareToLive, Chemotherapy, David B. Agus, Dendreon, Dr. Pazdur, FDA, foia, Freedom of Informatioin, Genaera, howard i scher, Howard R. Jonathan W. Simons, Howard Scher, Immunotherapy, Jay Moorin, Jesse Goodman, M.D., M.D. (Chairman), maha hussain, metastacized, metastasis, Michael Milken, Pasquale DeAngelis, Ph.D., Princeton, Proquest Investments, Prostate Cancer, Prostate Gland, provenge, Radiation, Samuel R. Saks, Seeds, Soule, Stuart Holden, Thomas Fleming, William G. Nelson
November 15th, 2007 at 6:22 am
I am still amazed and puzzled that something this criminal could be orchestrated by our own goverment agency and the doctors that have taken the oath to help patients. Such an travesty will never stand in the land of free. Truth will be revealed and these criminal elements will face justice. Clean up this corrupt agency called FDA immediately and approve Provenge now so that the PC patients can be saved.
November 15th, 2007 at 6:52 am
Bulls eye! This hits the intended target dead on. The MOA might be based on conjecture, but it is inspired conjecture and is incredibly effective
November 15th, 2007 at 7:43 am
Scher and others like him want Guinea Pigs for money. It doesn’t matter how many Guinea Pigs die if the eventual payout is a few billion to investors and pharmaceutical companies.
We continue to hear publicity campaigns from various organizations that want donations to search for a cure for cancer. Searching for “the cure” is largely a joke, a ruse supported by the big pharmaceutical companies. The drug companies don’t want a cure. They want money. And the most money is in chemotherapy and cancer pain management. Imagine the hit pain management and disease management drug sales would have taken if the age of immunotherapy would have begun.
All of the big pharmaceutical companies are aware of Dendreon. In the weeks before the FDA decision, witness the Bristol Meyers head of research saying Provenge would never be approved. Bristol Meyers has a cancer treatment franchise. Dendreon can advance cancer treatment by miles, possibly curing many men of PC and eventually curing many people of cancer with its platform. Companies like Bristol Meyers and investors like Howard Scher do not want to see Dendreon succeed. Unfortunately, there are a lot of companies like Bristol Meyers and doctor-investors like Scher. Scher and others like him want Guinea Pigs for money. It doesn’t matter how many Guinea Pigs die if the eventual payout is a few billion to investors and pharma companies.
We continue to hear publicity campaigns from various organizations that want donations to search for a cure for cancer. Searching for “the cure” is largely a joke, a ruse supported by the big pharmaceutical companies. The drug companies don’t want a cure. They want money. And the most money is in chemotherapy and cancer pain management. Imagine the hit pain management and disease management drug sales would have taken if the age of immunotherapy would have begun.
All of the big pharmaceutical companies are aware of Dendreon. In the weeks before the FDA decision, witness the Bristol Meyers head of research saying Provenge would never be approved. Bristol Meyers has a cancer treatment franchise. Dendreon can advance cancer treatment by miles, possibly curing many men of PC and eventually curing many people of cancer with its platform. Companies like Bristol Meyers and investors like Howard Scher do not want to see Dendreon succeed. Unfortunately, there are a lot of companies like Bristol Meyers and doctor-investors like Scher.
November 15th, 2007 at 9:33 am
It seems amazing to me that more people are not outraged by this screamingly overt sabotage. I don’t know why EVERY cancer advocacy group is not up in arms over such a blatant power play. What are *news* media doing repetedly pumping out sensationalist pop-culture crap? Check out just about every big media source and you’ll see what’s going on with “K-Fed and Brittney” or shill spew spinning the corruption of big money (big pharma, government, beauracracy).
That’s why Caretolive is so very important. The focus is for the individual patients and their own right to make decisions and choose how to live. Amazingly, for FDA in the case of Provenge the patients are last or not even in the equation at all. Testing has been done for years. It’s safe. Experts weighed in and the votes on the AC Panel was overwhelmingly in favor of approval. WHY was this expert panel disregarded? WHAT was Richard Pazdur even doing meddling about, passing notes to Maha Hussein, who conviently had her own letter leaked to the Cancer Letter echoing Scher and Flemming’s dissent from the panel of experts clearly dominant opinion.
And where is Andrew Von E? HOW and WHY has he let this corruption flourish under his new watch as head chief of FDA? Is he facilitating Pazdur’s iron fist rule and power mongering? There have been rumors about Von E possibly appointing Pazdur to a new saftey chief position. So, Pazdur leaks the ImClone information to some lawyer “mistakenly”, threatens walk-outs and such when his Ontology “club” doesn’t get what they want, and derails Provenge by obvious measures. Hmm, what a perfect candidate for a safety chief. All of these men dying from APC because they are denied their own right to choose drugs like Provenge, are they safe? Are they safe from possible mild, flu-like symptoms when they are dying? Is his concern for absolute statistical purity good reason to eliminate a novel drug that is safe and apparently increasing survival. Why not conditionally approve?
Why indeed. Lots of questions to be asked while the FDA discloses none of the answer. Corrupt FDA officals should have NO immunity from questioning their actions. They are supposed to serve the people not themselves.
May they reap what they sow.
November 15th, 2007 at 10:36 am
“When doctors consider whether to prescribe certain treatments, “it may be time we focus less on statistical significance alone, and more on patient benefit.” He noted, for example, that just-released data from a trial of satraplatin plus prednisone did not confirm a survival benefit, but did suggest that the combination was effective against pain, which appeared to translate into a slowing in progression of clinical symptoms.”
Dr. Howard Scher
February, 2007
http://www.medpagetoday.com/Urology/ASCOProstate/tb/5142
Is the FDA still a science based agency or is it now all about money and politics?
Provenge is the rare cancer drug that works better than existing therapies and has virtually no side effects. The only reason it was not approved is that the drug belongs to a small independent biotech company, and entrenched powers within the FDA have been effectively controlled by big pharmaceutical companies working on competing products.
These companies want to sell their toxic and less effective chemotherapies to the same patients, so they lobby FDA docs like Howard Scher and Maha Hussein to insist on large trials meeting ever-higher statistical standards well beyong the legal FDA mandate. They do this by hiring Scher and Hussein as consultants or funding their research on big pharma drugs.
The policies that Scher and Hussain promote in the FDA then sets playing field that tilts in favor of big pharma, as small biotechs who don’t have the resources to run huge trials have to either stop product development or sell out cheaply to big pharma. So the FDA rapidly approves drugs with known serious side effects to treat large numbers of patients for chronic conditions when the drugs belong to big pharma (like Merck’s Vioxx of arthritis or GSK’s Avandia for diabetes), and yet won’t approve a true advance in cancer treatment for patients who have a life expectancy of less than 2 years.
November 15th, 2007 at 11:19 am
I am also sleepless, but for an entirely different reason. I know first hand what this deadly decease does to a human being. It effects the young as well as the elderly and is not bias to any one race or background. I am aware of the terrible suffering that not only the poor cancer patient has to endure, but their family’s, friends and loved ones also suffer in many different degrees. I am not going to get into the subject of the many elected cowards that have been notified of this terrible wrong and have yet to stand up and fight for the people as they were elected to do. Instead most are staying on the sidelines weighing out how can interceding in this terrible dilemma help my own personal position and career.
What I will address is how can so called Doctors that fully understand and know first hand what this decease does to the human body and the suffering that these poor helpless patients have to endure daily, sell out every aspect of what their profession is supposed to stand up for under any condition. Do they fully understand what the term ” DO NO HARM ” means? One must understand that in this particular case at hand, is there are many so called Doctors that took part in this derailment of a promising vaccine that very well could extend or even cure this deadly decease for PC patients that are now left with very little hope, because of these so called Doctors criminal actions. I state criminal, because when one sells out a patients welfare for their own selfish personal gain, which in return causes continued suffering and even death, then it is criminal to do so, no matter how hard they have tried to confuse the true facts.
This is a proven safe vaccine and therefore should have been given an approval under the minimum conditions of being labeled for terminally ill PC patients and to have allowed them continued hope and the benefit of the possibility of extending their lives or even curing them of this deadly decease. The standard of care so to speak, would have only come after showing the true effects while maintaining hope for these poor patients. This is what would have been called using caution and at the same time, DOING NO HARM”. Every one of you so called doctors that was a part of this derailment of provenge, have brought shame to your medical profession, your family, your peers and humanity itself. I did not cap doctors anymore, because in my book, you are worse than a common thug and the title of ( Doctor )should be stripped forever, due to your outrages actions in this case at hand. For the continued majority of good and caring true Doctors out there, I commend you and your chosen profession in helping your patients and not lowering your standards as these so called doctors have done for their own personal gains. I only hope that some of the Good Doctors that are aware of this outrages situation will stand up and shame each and every one of these rouge so called doctors each and every chance that becomes available, because the truth is they have slapped you in the face without regard to your profession. Shame on them forever.
Lady Justice will prevail in the end , signed, Walk
June 27th, 2008 at 2:11 am
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