Provenge Lawsuits May Be A Sideshow, But Cancer Patients Should Keep Fighting
3 CommentsBy Ed Silverman // August 14th, 2007 // 7:28 pm
That’s the view held by David Miller, who publishes Biotech Monthly, a widely newsletter that mixes cogent analysis and clever insights. He’s followed the Provenge saga quite closely and, in fact, back in June published an essay that provided a fascinating glimpse into some of the behind-the-scene machinations at the FDA.
We chatted briefly with Miller this week in light of the recent lawsuit filed by a non-profit, which was created on behalf of investors and patients who are angry the FDA back-pedaled on approving the prostate-cancer vaccine from Dendreon, after an FDA panel recommended approval. The impetus for the about face? Two dissenting panel members - Howard Scher and Maha Hussain - wrote the agency, urging a go-slow approach, which created an uproar.
Pharmalot: Those letters are the subject of intense speculation. What’s your take on why they were written?
Miller: I believe the letters were always intended to be released to the public, and not intended to be kept within the FDA. I think they were written at the urging of Richard Pazdur (who heads the FDA Office of Oncologic Drugs) for his own reasons….Maha wrote her letter. I think the bulk of Howard’s letter was written for him by others….
…But I think he did this as a favor to Pazdur. I don’t think he expected it to become a controversy and have to one day defend himself against all these accusations.
Pharmalot: Pazdur is at the center of this and he supposedly maneuvered because he wants to oversee all cancer approvals (the FDA oncology office is part of the Center for Drug Evaluation and Research, and vaccines are reviewed by the Center for Biologics Evaluation and Research). Would he speak with you?
Miller: Richard is someone who makes himself available on an irregular basis. The people who shared this information with me are whom we’ve used as sources for our publication for years.
Pharmalot: Pazdur is named as one of the defendants in the latest lawsuit, along with the FDA commissioner and Scher, as trying to sabotage approval. Do you think this will have any impact?
Miller: I’m not sure the sideshow is going to benefit Provenge. These lawsuits (there are also shareholder lawsuits) will take years. I’m not sure the facts are clear enough for the courts to provide injunctive relief. The only way for any rapid action would be to have Congressional testimony, because that would provide cover for von Eschenbach and CBER to approve it, but Congress is in recess now. So the chances the effort will mean approval will come any sooner are pretty small.
The shareholder lawsuits are nonsense and will probably be dismissed with predjudice as soon as they are given audience in front of a judge. The manufacturing issues that are at the heart of the plaintiff’s case would not have delayed the approval of Provenge.
But there are two points of view in my comments. One is whether the effort to affect (the Office of Oncologic Drugs) and the FDA oncology approvals, and another concerning the investment implications for this in terms of Dendreon. On the former, I believe there’s an excellent chance (of influencing the approval process). The latter, due purely to timing of Congress and (the FDA’s decision to require) interim (survival) data has a percent chance of getting Provenge to market sooner. I would hate to have anything dissuade patients from continuing to work hard to change harmful OOD and FDA policies.
Scott
More great coverage. Keep up the excellent work (both Ed and David).
In keeping with the them of pushing hard NOW for congressional inquiry and FDA explanations/reversals, we’ll be rallying in D.C. on September 18th. More details at:
http://www.arighttolive.com
Because we believe patients have A Right To Live, don’t you?
The FDA unquestionably got it wrong with Provenge and if Congress has to be the one to ‘provide cover’ for the FDA commish, fine, let’s get it done NOW.
82 men died again today without being able to get access to Provenge. More than 7000 men have died since the FDA’s deporable decision to push back approval of Provenge while waiting for even more data. That blood is on the hands of the FDA decision-makers.
Patients need Provenge Now!
(In case you’re wondering, no, I don’t own any Dendreon stock, I’m a patient advocate who believes strongly that nobody knows better than cancer victims what they should be trying in order to prolong their lives. Right now, there is NOTHING out there that offers a beter risk-benefit profile in late-stage prostate cancer than Provenge. Provenge followed by Taxotere may be even better given the way they can work together to boost the immune system on one hand and kill the cancer several different ways at the same time.
Let’s get Provenge for patients NOW!
http://www.arighttolive.com
Come out and show the FDA AND Congress that we won’t wait another two years while 54,000 more men die painful deaths because Richard Pazdur or anyone else needs more sacrifices at the altar of statistical purity. No more playing politics, these are REAL LIVES at stake, EVERY DAY!
Sincerely,
Scott Riccio
Tony F
Ed, you and David have certainly added yet another public opportunity for people to be exposed to this travesty. Thank you!
It’s interesting that David believes, based on his undisclosed “contacts” that Pazdur is behind the letters from Scher and Hussain and that he notes Scher’s letter seemed to be written by more than 1 author.
Regarding the advocate lawsuit, remember that they are asking for no MONEY… the purpose of the suit is to get an EMERGENCY injunction against the FDA to allow the marketing of Provenge to those patients, in consultation with their own physicians, who believe Provenge can help extend their lives with an Excellent Quality of Life vs. the potentially deadly effects and poor QoL from Taxetore alone.
What’s doubly exciting is that Provenge, when combined with a reduced Taxetore, shows an even better potential to extend life. Hence, it appears that the Oncologists need not fear Provenge; rather, they should embrace it as yet another tool in their arsenal to fight end-stage TERMINAL prostate cancer.
Thanks also to David for encouraging the advocates and cancer victims to continue to fight for the right to this cancer treatment!
Kyoto27
Ed, thanks for keeping the FDA/Provenge story alive, because with each passing day the idea that
Provenge was issued a CRL because of the FDA’s ‘good science’ concerns is looking more and more like an insult to good science.
Witness that the FDA hides behind the good science mantra in its right to study this drug further, avoiding in the process what the brouhaha is all about:
Whether immunotherapy treatments need to be judged by a different standard than chemotherapy treatments?
Sadly, the FDA already knew/knows the answer is yes —as they were told just that at the NIH/NCI workshop they hosted in February 2007, and were reminded again recently by the NCI’s Dr Jeffrey Schlom:
“Clinical data are providing evidence that patients are living longer following vaccination, de-spite the fact that trials do not show the vaccines can induce the immune system into shrinking tumors,†said Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute. “The data suggests that the scientific community and regulatory committees ought to rethink the design of clinical vaccine trials and our current approach to measuring the effectiveness of a cancer vaccine.â€
And yet the FDA went blindly ahead overruling the findings of its own workshop and its own Provenge Advisory Committee where every single member of the AC who had recognized expertise in immunotherapy (and they were from Moffit, MD Anderson, NIH, Harvard, Stanford, UCLA, Duke, U WA) voted 13-4 that there was “substantial evidence” of effectiveness and unanimously (17-0) that there were no safety issues. Not one of the “no” voters on the panel had recognized expertise in immunotherapy. The drug in question was an immunotherapeutic agent.
So if all the FDA wants to continue to study (in the name of “good science†) is why the round ball will not fit into the square hole, the inner workings of the FDA process appear to be seriously flawed and far from science based.
It hope that America’s cancer patients, and citizens are being held hostage at the FDA because of academic turf wars, financial interests or the chemotherapy industry.
Keep following this story Ed…in the defense of good science and the truth!