More companies and cancer patients are imploring the FDA to approve experimental cancer meds, even when current approval standards aren’t met. Pharmacyclics recently refiled an application for its cancer drug, despite agency refusal to review it in February. Cell Therapeutics argues its lung-cancer drug is being delayed by the FDA’s insistence it conduct another trial. And prostate-cancer patients and shareholders have protested the FDA’s refusal in May to approve Provenge vaccine by Dendreon.

Yet another example is Antigenics, which is pushing a subgroup analysis, something the FDA resists, as The Wall Street Journal (subscription required) writes this morning. The issue, however, is becoming more heated as patients - and, of course, investors - argue that meds for life-threatening diseases such as cancer deserve the same type of flexibility and novel thinking that allowed AIDS treatments to be fast-tracked two decades ago.

“We have to find creative ways of getting cancer drugs to patients even if we end up being wrong a few times,” David Kessler, dean of the school of medicine at the University of California, San Francisco, tells the paper. He was FDA commish during the AIDS epidemic, when he amended the approval process to speed 12 new treatments to market.

FDA officials defend current standards, saying it’s better to delay a new drug until there’s definitive proof it works. “I don’t think you want the FDA to approve a drug saying there’s a chance this works. I think you need to know the therapy works,” says Bob Temple, director of the FDA’s office of medical policy. “If somebody uses a vaccine that doesn’t work, they will be forgoing something else.” While he recognizes some patients have “no options left,” he says the best route for them is to appeal to the FDA and to drugmakers for permission to use experimental meds.

But Joel Nowak, 56, who had a kidney with a large tumor removed last year, says patients with life-threatening illnesses want to take greater risks than current standards allow. Having lost his mother, father-in-law and sister-in-law to cancer in the past two years, he’s cognizant of what will happen if his disease recurs. “The FDA standards don’t reflect the seriousness of the situation terminally ill patients are in,” he tells the Journal. “It’s not a headache I’m talking about - I’m talking about how long I’m going to be breathing.”