• This is a rush transcript from "The Journal Editorial Report," April 28, 2007.

    PAUL GIGOT, FOX HOST: This week on "the Journal Editorial Report: " warning, government bureaucracy could be hazardous to your health. How red tape is keeping life-saving cancer drugs out of the hands of those who need them.

    Key senators strike a bipartisan deal and end up bringing 12 million illegal immigrants out of the shadows.

    The Falwell legacy. The founder of the moral majority is dead, but what influence will evangelicals have in 2008?

    First, these headlines.


    GIGOT: Welcome to the "Journal Editorial Report." I'm Paul Gigot. The Food and Drug Administration last week succeeded in kill two more promising cancer therapies, the latest victims of the agency regulatory obstacles and red tape.

    Doctor Scott Gottlieb is a practicing physician who recently left the FDA where he served as deputy commissioner. He joins me now from Washington.

    Scott Gottlieb, welcome. Good to have you here.


    GIGOT: About 1,500 Americans die from cancer every day, more or less, yet the FDA recently didn't approve drugs for prostate cancer and rare bone cancer in children. Were those good decisions?

    GOTTLIEB: Well these were two drugs, which were new kinds of therapies. They are immunotherapies. They work by boosting the body's ability to fight the cancer. It is a new paradigm in cancer treatment.

    In each case, there wasn't really a question about the safety of these products. That was pretty well-established. The questions the agency had were around just how effective were they. In each case there was evidence that they were effective, but that evidence didn't rise to the bar that the agency is setting which is a new statistical standard. A higher standard, if you will, than what it has looked at in the past.

    In at least one case with one drug, Provenge, the drug for prostate cancer, an outside advisory committee to the FDA of medical experts voted 13-four the drug should be approved. And the agency didn't go with that decision.

    GIGOT: You are talking about a standard — I think a statistical standard that the FDA says you have to have 95 percent certainty the drug is effective. That might be fine if you have flu or something commonplace or cure for a cold but if you have terminal cancer or very serious cancer, wouldn't you want to settle for a 50 percent chance of effectiveness or even maybe a 10 percent chance? Give you the chance to extend your life?

    GOTTLIEB: I think a lot of people would be willing to tolerate more uncertainty, especially with cancers that are otherwise terminal. It is not just the statistical certainly by which a product needs to demonstrate effectiveness to meet the FDA's requirements, but also the kind of trial that needs to be conducted. Increasingly, the FDA's requiring placebo control trials that are randomized, which means patience that enter the clinical trials either get a sugar pill or the active drug and don't know what they are getting.

    GIGOT: Is that fair for cancer patients? Somebody who is really sick?

    GOTTLIEB: I think in a lot of cases it is probably not fair and it does test ethical boundaries, but particularly with the immunotherapies, it could be the wrong paradigm for testing drugs. The immunotherapies might well work better in people who have earlier stage cancers, who still have immune systems capable of being boosted, but the placebo controlled trials — when you run a placebo controlled trial it is often the case that people with early stage cancers don't want to enter the trials. So you are forced to have to recruit people who have very late stage cancer. Those might be the very people who don't respond to these drugs. So it could very well be that we have the wrong model for testing these kinds of drugs.

    GIGOT: How much of this is a fall out from the Vioxx controversy where that drug, a pain killer, was pulled from the market after it was found too increase the risk of heart attack in some patients. Big political flare-up over that. People said the FDA moved too fast to approve it. Is this a counter reaction a counter reaction, a blow back against that political uproar?

    GOTTLIEB: Well, I don't think you have seen that in the cancer space. This has been a movement that's been under way for a number of years now to try to increase the statistical, the mathematical certainly of effectiveness of drugs approved in the cancer spacious. Usually safety questions aren't the issue whether it comes to approvability of a new cancer drug.