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Conspiracy Theory About Dendreon's New Cancer Drug Could Soon Unravel

By Jim Edwards

Updated on: February 5, 2010 / 11:24 AM EST / MoneyWatch

If the FDA approves Dendreon (DNDN)'s prostate cancer drug Provenge on May 1, it will prove that there was not a conspiracy at the FDA to keep this drug off the market.

While the community of Provengistas -- ardent advocates of the drug -- that has grown up around Dendreon will be happy to get their hands on this new therapy, the victory will be bitter sweet for them because it will prove that the FDA was not part of some grand scheme to keep new medicine out of the hands of dying men.

The FDA took its gloves off this week in its battle with the Provengistas: It filed a brief in federal court calling their theories "unfounded allegations and conspiracy theories."

In the suit, CareToLive had filed a Freedom of Information Request with the FDA demanding all its documents on Provenge. Although the FDA delivered several batches of documents to CTL, and then declared it had no more to offer, CTL believes the FDA is still hiding documents because Office of Oncologic Drugs chief Richard Pazdur admitted some of his documents had been destroyed and FDA had not used an IT expert to search his computer for recoverable fragments of the documents.

A federal court judge already ruled that the FDA has done all it needs to do to respond to CTL's request. You can get an idea of how flimsy the straws that CTL is grasping are by this line from the ruling:

Plaintiff does not dispute that the correspondences that Dr. Pazdur admits were destroyed are duplicates of documents already produced to Plaintiff by the FDA.

But still CTL insists that -- like the missing 18 minutes of President Nixon's Oval Office tapes -- there must be something more. The FDA is having none of it:

CareToLive had hinged its request on its unfounded allegations and conspiracy theories about the veracity of Dr. Pazdur's declaration, and its belief that additional documents "must" be out there. As CareToLive did not present any evidence to support its claim that the agency had acted in bad faith, the district court acted well within its discretion in denying the request for discovery.

CTL will likely lose its appeal. Meanwhile, events taking place in real life appear to be demonstrating that Provenge is right on track and not the subject of an effort to suppress its existence. The company will get a decision on May 1. CEO Mitchell Gold (pictured) says he sees no indication of further delay at FDA. He's planning a 2011 launch. And the delay has actually given Dendreon an opportunity to raise a further $400 million in a new stock offering to fund manufacturing.

Which means that unless FDA really upsets the apple cart on May 1, a long-running conspiracy theory will finally come to an end.