The Provenge story proves that drug development guided by Wall Street values is as likely as NIH’s to be continually outstripped by new discoveries. The question is, what do you do when that happens. Do you rush your product to market ahead of the news or do you stay the course and face problems head on?

“I worked in a field where ten seconds was a long decision process,” Milken told Daniels. “Either you’re buying the securities or you’re not. Either you’re selling them or you’re not.” Was this ever an adequate background to bring to cancer research? We know where it led Sam Waxel and Martha Stewart. And Imclone’s inadequacies damaged cancer patients.
“The basic reason for ImClone’s meltdown,” wrote prostate cancer patient Bill Aisman while taking chemotherapy, “was not financial accounting irregularities — the irregularities were in the accrual, reporting, and conduct of the clinical trials of Erbitux (IMC-C225). These irregularities are beyond the pale of financial greed — these irregularities strike at the very heart and lives of all cancer patients, the conduct of clinical trials, and the veracity of the thousands of clinical trial abstracts and reports on which cancer drugs and treatments are based.”

Herceptin (recombinant humanized anti-Her-2/neu antibody) was a revolutionary drug yet the approval process leading up to and following FDA’s approval of it in 1998 was rigorous and conservative. The process did not alienate either patients or oncologists.

The approval process for Herceptin did not exploit fear of chemotherapy — “One group of researchers found that women who took the drug along with standard chemotherapy survived longer than those who received only the chemotherapy. Another group found that Herceptin alone could help some women whose cancer was not responding to chemotherapy.”

The approval process for Herceptin was based on Phase III trials large enough to power statistically valid conclusions (some 900 patients compared with some 200 in the Dendreon trials combined).

The approval process for Herceptin did not raise false hopes — the researchers identified the population of women whose breast cancer was most likely to respond (women with HER2-positive, advanced breast cancer). And they went on to identify a risk of cardiomyopathy from Herceptin especially for women who took it with chemotherapy.

The approval process for Herceptin culminated in Genentech Inc’s announcement on September 28, 1998 that they would “provide Herceptin therapy for all patients in the United States, regardless of economic or insurance status, as they do with all their marketed products.”

(Since Herceptin Genentech has created 2 more cancer drugs, Avastin® (bevacizumab) and Tarceva® (erlotinib). According to the New York Times, many patients cannot afford to pay for these drugs.)

Time will tell whether the Provenge approval process, which Howard Scher M.D.and Maha Hussain M. D. have tried to slow down and which patients, advocates, national support groups, the Dendreon company and its investors naturally want to speed along, will stand as a sustainable model. If FDA approves Provenge without waiting for results from the ongoing 500-man clinical trial, thousands of patients who would never want to to take on the risks of entering a clinical trial will, in fact, become guinea-pigs. A better way, as Dr. Hussain suggests, would be for Dendreon to supply the vaccine to men in need while the trial is completed.

And why not ask Michael Milken to help underwrite such a project? At this juncture one can only hope that a great many patients with advanced prostate cancer will receive from Provenge what those who spoke at the FDA meeting asked for:

“An opportunity to extend my life.” – Joel Nowak

“A badly needed option.” Jim Waldenfels

“Once Provenge becomes available, I believe there’s a further possibility that men with less advanced disease and good immune systems like myself could conceivably benefit markedly from it. I would really like to see Provenge be the fourth arrow in my quiver.” Ed Grove

“Hope … for my neighbor …. as I review my own relationship with my neighbor over there, if he had Provenge this all might have been prevented.” Richard Gillespie

“[giving] up to 50,000 waiting men, maybe more, new hope and new life with an alternative treatment that works.” Alvin Chin

“… a launching pad for a dramatic increase in the enthusiasm and investment for cancer research, which we all know will ultimately put us much closer to the second and the third and the fourth generation of this kind of product. I have an 8-year-old daughter and a 5-year-old son. I want to be around to see my kids grow up. I want to see them go to college, get arried, and I want to see them have their children.” Joel Fleischmann

Op-Ed by J. Strax.