|Scanning electron micrograph of prostatic cancer cell, magnified 6,000 times. |
In 2004, Life Extension reported on a Phase III study showing that men with metastatic prostate cancer who received an immune-boosting vaccine called Provenge™ were eight times more likely to live six months without disease progression than those who did not receive the vaccine.1 This anti-cancer vaccine, however, was effective only in men with a Gleason score of 7 or less. (Higher Gleason scores are indicative of a more aggressive type of prostate cancer.)
The FDA refused to accept the study results because the agency does not allow retrospective analysis of a subgroup that may have benefited from an experimental drug. To gain FDA approval, Dendreon, the company testing the vaccine, was forced to begin a new study on men with Gleason scores of 7 or less. However, Dendreon continued to follow patients in the original study, and the results continue to be impressive. Of the 75 patients who entered the trial with a Gleason score of 7 or less, those receiving Provenge™ were 3.7 times more likely to be alive after 30 months; this translates into 53% of the Provenge™ group staying alive compared to only 14% of the placebo group. The Provenge™ group also remained pain-free twice as long on average as the placebo group.
A Wall Street Journal editorial commented on the FDA’s deplorable delay by stating:
“We know that it works, and we know why it works. In any rational regulatory environment, that would be reason to speed Provenge™ to market. But this is the FDA we are talking about.”2
Fast forward to 2005, and the results of a new clinical study on Provenge™ show that three times as many advanced prostate cancer patients who received Provenge™ were alive compared to patients receiving a placebo.3 This study evaluated 127 patients with prostate cancer that did not respond to androgen-deprivation therapy (that is, hormone-refractory prostate cancer). Cancer experts consider this patient subset to have a dismal prognosis, with most dying of the disease within a few years. In the Provenge™ study, 34% of the patients receiving Provenge™ were still alive after three years compared to only 11% of men who were randomly assigned a placebo.3
Under FDA regulations, pros-tate cancer patients with such a dire prognosis had to risk receiving no therapy (the placebo) in the hope that they might be lucky enough to be in the study arm that received the promising drug (Provenge™). Life Extension has advocated that cancer patients with advanced disease should not have to risk receiving a worthless placebo. Historical controls could be used instead of placebos to spare such patients almost certain death.
Prostate cancer kills more than 30,000 American men every year.3 Provenge™ has clearly demonstrated that it improves survival rates, yet the FDA still has not approved it. Considering that the FDA could have approved Provenge™ as early as 2002, the agency’s delay in approving this one drug alone may have resulted in the premature death of tens of thousands of men.