FWIW, I think any political appointee and his entourage these days are just shills for the administration and unconcerned about scientific evidence. I don’t trust those guys, either. Remember the Surgeon General, Dr. Carmona, who said he was “surprised” he was asked to ignore science and spout the party line?

That’s not what the overwhelming majority of Advisory Committe members voted in the case of Provenge. The decision denying Provenge immediate marketing approval was
made in a vacuum by individuals who have benefited from promoting a competing product to Dendreon.

Welcome!111

By the way, if you want the product, and if Dendreon can make it, you can probably get it whether it’s approved or not. FDA will help your doctor file a Treatment IND and you can contact the Office of Special Health Issues at http://www.fda.gov/oashi/home.html. But if the reason you can’t get it is the manufacturer can’t make it, they won’t be able to reveal that is the reason, because that’s confidential commercial information.

Complete rubbish. “Manufacturing biologics is hard”… huh? no, not hardly. Developing biologics…sure, but not manufacturing.

“dangerous variations batch to batch”.. Really now? please do tell.

Even autologous vaccines have to have identifiable similarities for a clinical study to produce good data. The purpose of a clinical study is to show how a product works across an entire patient population. If it doesn’t show that, the “study” has an N of one. If the product is that unique, then they can’t sell it as a commercial drug. Commercial drugs and biologics are required by law and regulation to have uniformity from batch to batch. If it doesn’t, maybe it can be sold as an indivdualized treatment, one patient at a time, but not as a drug or biologic. My guess is insurance wouldn’t pay for it under those circumstances, or if they would, it still wouldn’t be commercially viable. So like every company, they need to show with substantial evidence from clinical trials that they can make a product with the same critical characteristics every time.

Blood can be an autologous product, and it’s regulated the same way. It can have variations, but the critical characteristics have to be identified, tested for and present, or else it’s not blood, and is adulterated and misbranded. Dendreon must be held to the same standard.

I’m not saying it’s not frustrating, and a treatment can be dismissed. I’m saying like every product, it must prove itself. The burden is on Dendreon. And many R&D and biological companies won’t follow a protocol or manufacturing step to save the company, themselves, or their patients.

These issues won’t necessarily be dispositive of the product. A-Von might not have seen the emails. The advisory committee membership issue is also troubling, but we’ve heard that for decades, too. The alternative seems to be to pay the experts enough to give up the other jobs (and taxpayers have been unwilling to fully fund FDA for 20 years or more) or hire people whose expertise is so low or unappreciated that no one else will pay them for it. I’m troubled by all the allegations raised here, but even if it’s all true it doesn’t prove that any particular product deserves approval.

You doofus, of course the batches are going to be ‘wildly different,’ and of course ‘the data with patients from different batches can’t match up.’ Provenge is an autologous vaccine. Do you know what that means without using google or wikipedia? OK, I’ll help. It’s patient-specific. The patient gets his blood drawn, and the dendritic cells are removed and sent to the mfg plant, where they are combined with a prostate cancer-specific antigen and an already improved immune system booster to form Provenge. No two sets of blood from different patients are going to be alike. Did you think Provenge is like GVAX? If you really did work for the FDA, were you fired for incompetence?

Is this just more bunk!?! What does manufacturing Provenge have to do with proof that Dr. Scher lobbied his personal friend, Commissioner von Eschenbach, well after the Advisory Committee to delay Provenge whereby Dr. Scher did gain financially from the decision.

Dr. Francesco M Marincola, who himself participated in the Provenge AC, stated that his role as member of the Advisory Board was “to express his opinion during the meeting but it would be ill advised to influence the FDA decision beyond that point.”

As employees of the FDA, they each have a fiduciary duty to up hold to all Americans. The foundation of their position is based upon good faith, loyalty, and trust. Do you honestly consider that the FDA has responded to the FOIA requests in good faith? The FDA to this day has not provided any documents from Dr. Pazdur who, it is widely suspected, leaked confidential letters to a periodical called “The Cancer Letter” that was inimical to the approval of Provenge.

As a fiduciary, each must not put themselves in a position where their interest and duty conflict. In the case of Howard Scher, his fiduciary duty at the FDA interfered with his fiduciary duty at Proquest Investments. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make the either the plaintiff or the defendant’s interests a top priority if both the plaintiff and the defendant’s interests are diametrically opposed.

Knowing of Dr. von Eschenbach’s own personal history of conflicts of interest, how is the public to believe that Dr. von Eschenbach is serious about enforcing FDA policy regarding disclosure of conflicts of interest for Special Government Employees participating in FDA Advisory Committees? I believe the Commissioner himself was instrumental in the Provenge decision. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests or under the auspices of science. The FDA subjected the terminally ill AIPC patients to more suffering whereby a few would benefit financially.

It is clear to me that the science and normal process at the FDA was overturned by a small group of people with inordinate influence and subverted the process and had nothing to do with producing Provenge consistently and reliably. The Provenge advisory panel confirmed that Provenge met all the criteria for marketing approval. There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.

The ease of Dendreon’s commercial scale manufacturing is just one more reason why Dendreon is unique in the so-called biologics space. I suggest exFDA talk to Dendreon’s Dr Urdal.

Too many seemingly excessive, almost ‘absolute’ claims which purport to make your point. But no evidence, nor supporting arguments. Just … well … rhetorically inflated claims.

An invitation: please come to the Investor Village/DNDN board (home away from home for many of us who cherish Ed’s humor and intelligence laden ‘abode’). There you/we could have an extended discussion with several M.D’s., some biologists, a few professional mathematicians and statisticians and other members of the general public.

If you are correct I think, after the initial shock, protests etc., you would find most everyone grateful for the enlightenment. If you are not correct, well …?