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.
SCOTT GOTTLIEB, PHYSICIAN, FORMER FDA DEPUTY COMMISSIONER: Thank you.
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.
It is true that Vioxx and some other drug issues have increased the scrutiny of the agency. I think what that caused to happen inside the agency is that it is given more voice to people who might of might have had a minority point of view inside the agency. That could be affecting some of these reviews, where people who otherwise might not have been in the majority in terms of their views of the science and their opinion are now able to have more sway in the process.
GIGOT: But just so I understand, you are saying there is a difference of opinion among cancer doctors and oncologists about whether or not the FDA is now getting too worried about the safety and efficacy concerns and should move faster to approve these new kinds of — let's face it — exciting kinds of therapy.
GOTTLIEB: There certainly is a split in the cancer community. You talk to people experts, you talk to people at the NCI, some have misgivings about the effort that's underway. It really is an effort, I think. It is a conscious effort. Other people support it. Other people say we shouldn't be approving very expensive new cancer drugs unless we are absolutely certain of their efficacy and we have very good clinical data to guide their use. There is a split in the cancer community, no question, among leading cancer...
GIGOT: Where do you come down?
GOTTLIEB: I think we should be able to tolerate a little more uncertainty when it comes to these kinds of drugs. And I think you are dealing with a therapeutic space where the clinicians are good at reading literature and explaining things to their patient. And they should shall given an opportunity to try new drugs.
It is also the case, Paul, that cancer patients don't just choose medications based on effectiveness but sometimes on the side effect profile.
In fact, there was a case where the drug Zarnestra, where the FDA didn't approve that drug for a very terminal form of blood cancer because it was worried the drug might not have been as effective as the leading therapy, but was far more tolerable. And they literally worried patients would be encouraged to use this drug rather than the standard of care, which might have been more effective because the drug was more tolerable. I would say that's a decision patients ought to be able to make.
GIGOT: I agree with you. Patients should be in on that decision.
Thank you, Scott Gottlieb.
When he come back, key Senators strike a deal with President Bush on immigration reform, setting the stage for what promises to be a bruising battle on Capital Hill.
And the legacy of Jerry Falwell. He was the facial of the religious right in the 1980s. What about 2008? Can a Republican win the presidency without the support of evangelicals? Our panel weighs in after this break.
GIGOT: Senators negotiators reached a bipartisan agreement on immigration legislation late this week aimed at providing a path to citizenship for 12 million undocumented aliens.
The plan, supported by President Bush, would give illegal immigrants a chance for permanent residency after eight years and eventual citizenship. It would create a temporary worker program, beef up border patrols and crack down on employers that hire illegal immigrants.
Joining the panel this week, editorial board member Jason Riley, editorial features editor Rob Pollack, opinionjournal.com columnist John Fund and deputy taste editor Naomi Schaefer Riley.
Jason, you paid attention to this legislation. Getting attacked by the right and left already.
JASON RILEY, WSJ EDITORIAL BOARD MEMBER: Yes.
GIGOT: Big picture do you think this is an improvement on current law?
RILEY: In some respects, yes. In other respects no, which explains attacks from all owe both ends of the political spectrum.
The parts of the bill dealing with what to do with 12 million illegals in the country I think are reasonable and enforceable. Deportation wasn't really an option and this doesn't do that. It gives these people a way to stay here and continue to help our economy grow.
More problematic, the guest-worker program that's been put into places or is proposed. That, I think, could use tinkering. Is that going to be enforceable? That's important. Because this is about making sure, going forward, U.S. businesses have access to the labor they need.
GIGOT: Naomi, what about this charge from the right that this is amnesty for the illegals that are already here because they get to stay here even after they have broken the law.
NAOMI SCHAEFER RILEY, WSJ DEPUTY TASTE EDITOR: I think the amnesty charge is just bunk. They have to pay back taxes. They have to pay a fee to stay.
GIGOT: $5,000 bucks.
SCHAEFFER RILEY: That is not nothing when you are working in the back of a restaurant, I'll tell you that. You can't get that on tips very quickly.
I think one other problem with the bill is a principle question. They are emphasizing more — they are de-emphasizing family reunification, and I think that's a problem for two reasons. First, obviously, we feel bad for these families and they shouldn't be separated. But second of all, this country has a long history of bringing people here who have very low skills, and then having children who then have PhD's. And you can't predict what the future is going to be just because you bring a low-skilled worker here.
ROB POLLOCK, WSJ EDITORIAL FEATURES EDITOR: Our current immigration laws are silly and impractical, it is hard to get outraged about the fact people are breaking them. I am about as outraged about that as when people drove over 55 miles per hour. It's just — who cares.
JOHN FUND, WSJ OPINIONJOURNAL.COM COLUMNIST: A lot of people are outraged. The biggest obstacle this bill has is cynicism and partisanship. A lot of Americans are deeply cynical the government can get anything right, after Katrina, after Iraq. So there is that obstacle.
Then, partisanship. A lot of Republicans fear the Democrats will pull the rug out from under them at the last minute after they have taken a lot of political risks to support this. A lot of Democrats simply want to have this as a 2008 election issue. Both parties completely distrust the other.
GIGOT: With Ted Kennedy, though, is a spokesman for the Democratic side. He can bring a lot of Democratic votes in the Senate. And I am told this may get as many as 70 or 75 votes.
FUND: Bob Menendez, the Democratic senator from New Jersey, is against it. The AFL-CIO is against it. I think the jury is out, Paul, as to whether or not the Democrats are going to unite behind this.
RILEY: Bush is very much for it and he said...
FUND: And he has how much political capital?
RILEY: True. But he said I am very anxious to get this done as soon as possible. I thank republicans what to get past this issue because it is so dividing petition they don't want that.
GIGOT: It would be good for the Republican Party to get this off the table and settled before the election of 2008? It is already dividing them newspaper primaries. John McCain actually came back to endorse it because the bill is endorsed by his fellow Arizona senator and staunch conservative Jon Kyl. Nobody better for conservative credentials in the Senate.
But Mitt Romney opposes it had already. And Rudy Giuliani, sitting right on the fence. He couldn't decide what to say about it.
FUND: I'll predict Giuliani eventually comes out against this bill, largely for political reasons.
GIGOT: All right. What do you think, John? Obviously is a long way to go but do you see the Democrats kind of saying, with Chuck Schumer, maybe we're not going to support it because we don't want to give Bush any political victory?
FUND: It can pass the Senate. Remember, this is a 100,000-page bill that's going to be rushed through in a week. I think the speed with which this is done...
GIGOT: Rushed through the Senate in a week, not the House.
FUND: I think that will create suspicion among the general public that somebody is trying to pull a fast one here. So I think it can pass the Senate. The House will be tough.
GIGOT: That's it.
When we come back the Falwell legacy. How the founder of the moral majority changed American politics.
GIGOT: The Reverend Jerry Falwell was remembered this week by supports and critics alike as a polarizing figures. He died Tuesday at the age of 73. He founded the moral majority in 1979 bringing millions of evangelicals into the political fold for the first time and leading to an alliance for the Republicans that has had a profound consequences for American politics over the past quarter century.
John, how important a political figure was Falwell?
FUND: Very important. People forget the moral majority started because the Carter administers was harassing Christian schools. Evangelicals thought we have been out of politics but now we need to get into it.
Falwell mobilized that resentment against the federal government into an enormous voter registration campaign at that got Ronald Reagan elected. Overtime though, Falwell lost influence.
Now evangelicals are more sophisticated. If you look at the polls, Rudy Giuliani probably is tied with Fred Thompson for support among the evangelicals. And Mitt Romney, who's a Mormon, who's generally considered suspicious in that community, has a lot of supporters in the evangelical community as well. It's matured over the years.
GIGOT: Falwell became a caricature of what liberals thoughts an evangelical should be, Naomi. That's what I thought.
SCHAEFER RILEY: Yes. He was. I think it is a very symbiotic relationship. A lot of people in the media wanted this to be the face of evangelicalism, even though it wasn't. And Falwell really enjoyed the attention.
GIGOT: The over-the-top statements, blaming the United States for 9/11 and things like that.
SCHAEFER RILEY: People to in the media wanted it not only to be the face of evangelicalism, but they also wanted evangelicalism to be the face of the Republican Party. That's another phenomenon.
SCHAEFER RILEY: Right.
RILEY: At the same time, I think a lot of his sympathizers today want to air brush his comments about blacks and gays and homosexuals because, as John said, he brought people out to the polls and helped Republicans win elections. I feel no such compunction to do that.
SCHAEFER RILEY: It wasn't just the public school issue. It was abortion also that rallied the evangelicals. I think that's important to remember because that is a legacy that remains a huge issue for the religious right today.
FUND: The biggest legacy is, of course, Liberty University, which is a top-notch school, which is producing all kinds of very important...
GIGOT: I want to get to 2008. You recently talked to Richard Land out of the Southern Baptist Convention, a very key figure in the evangelical political circles. What is he saying about the 2008 election for evangelicals?
SCHAEFER RILEY: He insists they have a lot of influence. I do believe them. I don't think Republicans can win without evangelicals. But that being said, they are splitting their vote. They are supporting all sorts of different primary candidates. That will dilute their influence over time in the Republican primary.
And then you see which ever one of these candidates' wins — if Rudy win, you could see a lot of evangelicals staying home. If Romney wins, you can see a lot of evangelicals staying home.
But I think what it's going to come down to is how important the war is for evangelicals because they want to win in Iraq more than most other Americans. And they might be willing to swallow their pride and go with someone like Rudy.
GIGOT: Are we seeing, for the first time in a long time, there may be the potential for the Republican coalition to shatter and someone like Barack Obama or Hillary Clinton — if she appears in church enough times — can get some of those evangelical voters to vote Democrat?
FUND: The Democratic candidate, whoever it's going to be, will talk about faith and their attendance in church more than anyone can imagine. I think evangelicals will cast about 30 percent of their votes for Democratic candidates. That's why it is important, if the Republicans who want to win, they have to have a candidate who can unite all strands of the Republican coalition, including evangelicals.
SCHAEFER RILEY: One thing Richard Land did say to me is that he hoped that evangelicals were not taken advantage of by the Republican Party the same way blacks are taken advantage of by the Democratic Party. That is, that the Republicans should not count on their votes. That's an important message.
GIGOT: Would he want to elect Hillary Clinton? He knows that the Supreme Court nominees that Hillary Clinton would make, or a Barack Obama would make, won't be anything close to the kind he's had under George W. Bush and may not get under a John McCain or Rudy Giuliani.
SCHAEFER RILEY: No, that's true. They are savvy and know what the result is if they stay home. I don't think evangelicals want to be faced with Hillary.
GIGOT: Some of this is posturing, trying to see if they can get their favorite candidate to win?
SCHAEFER RILEY: Yes, who might be Fred Thompson? They have to wait until he declares before he is the candidate.
RILEY: Which tell you a lot about their continued influence today that none of the frontrunners would be their ideal candidate?
GIGOT: We have to take one more break. When we come back, our "Hits and Misses" of the week
GIGOT: Winners and losers, picks and pans, "Hits and Misses," it's our way of calling attention to the best and the worst of the week.
Item one, a hit for outgoing British Prime Minister Tony Blair, loyal until the end.
POLLOCK: Big kudos to Tony Blair. He could have made himself popular at home by saying, like so many U.S. Democrats have, that he was misled by President Bush. But not only has he remained steadfast on Iraq, but he used what could be a farewell tour in Washington this week to warn against anti-Americanism and to emphasize the world is a safer place with America active and involved.
GIGOT: All right, Rob.
Next, John Edwards's excellent Cayman Island adventure — John?
FUND: John Edwards made a fortune as a trial lawyer. After he was Democratic vice presidential candidate in 2004 even he needed a part-time job. He went to work for a hedge fund, Fortress invests. He earned $40,000 last year for part-time work a few days a week — a month. It turns out Fortress Investments is incorporated in the Cayman Island, which is the ultimate off-shore tax haven.
John Edwards campaigned his entire political life against these off- shore tax havens where people try to pay less taxes. Now he says, well, I am still against the hedge funds. And I still will try to abolish their off-shore tax havens if I become president but, until then, he's going to collect all those tax-free checks.
GIGOT: All right.
And a hit to the Geico cavemen — Naomi?
SCHAEFER RILEY: The new fall lineup came out this week and it turns out the Geico caveman, that is the cavemen in Geico commercials, are going to get their own sitcom. I think this is a great hit.
The premise of the show will be how difficult it is to a caveman in America today. The commercials were really about how cavemen are probably the last people in America can you actually say something without offending. But it turns out we have offended them. That's the whole premise of the show. I think it is fascinating that people have good glommed on to this political incorrectness that, finally, we found someone we can say something mean about. and it is just that they happen to have died a few thousand years ago.
GIGOT: Finally tonight, Paul Wolfowitz resigned as president of the World Bank this week despite being exonerated by the bank board of false conflict of interest charges. That's right. He resigned after being exonerated.
But that's the way things happen at these multilateral outfits, like the bank, which are run by and for their own well-paid employees. Not really for the poor.
Wolfowitz had the fervent support of the poor Africans the bank is supposed to help. But his anti-corruption agenda offended Europeans and bank staff who did not want to be held accountable.
Wolfowitz emerges with his reputation in tact but the bank has shown itself to be a corrupt institution. And good luck to the next president in trying to shape it up.
That's it for this week's edition of the "Journal Editorial Report." I'm Paul Gigot. Thanks to all of you for watching. We hope to see you right here next week.
Content and Programming Copyright 2007 FOX News Network, Inc. ALL RIGHTS RESERVED. Transcription Copyright 2007 Voxant, Inc. (www.voxant.com), which takes sole responsibility for the accuracy of the transcription. ALL RIGHTS RESERVED. No license is granted to the user of this material except for the user's personal or internal use and, in such case, only one copy may be printed, nor shall user use any material for commercial purposes or in any fashion that may infringe upon FOX News Network, Inc.'s and Voxant Inc.'s copyrights or other proprietary rights or interests in the material. This is not a legal transcript for purposes of litigation.