Submitted for Your Approval
Cancer drugs, immigration and Jerry Falwell.

Monday, May 21, 2007 12:01 A.M. EDT

Paul Gigot: This week on "The Journal Editorial Report": Warning, government bureaucracy could be hazardous to your health. How the FDA's red tape is keeping lifesaving cancer drugs out of the hands of the people who need them most. Plus, key senators strike a bipartisan deal aimed at bringing 12 million illegal immigrants out of the shadows. And the Falwell legacy--the founder of the Moral Majority is dead, but what influence will evangelicals have in 2008? First, these headlines.

Dr. 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.

Gottlieb: Thank you. Thank you.

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

Gottlieb: Well, these were two drugs, Provenge and Junovan, which were new kinds of therapies. They're immunotherapies. They work by boosting the body's ability to fight the cancer. So it's a completely 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 that the agency had were around just how effective were they, and in each case there was evidence that they were effective, but that evidence didn't rise to the bar that the agency's setting which is a new statistical standard--a higher standard, if you will, than what it's looked at in the past.

And in at least one of the cases with one of these drugs, Provenge, the drug for prostate cancer, an outside advisory committee to the FDA of medical experts actually voted 13-4 that the drug should be approved, and the agency didn't go with that decision.

Gigot: Well, you're talking about a standard--I think a statistical standard that the FDA says you have to have 95% certainty that 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% chance of effectiveness, or even maybe a 10% chance? Give you the chance to extend your life?

Gottlieb: Well, I think a lot of people would be willing to tolerate more uncertainty, especially with cancers that are otherwise terminal. It's 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. And so increasingly, the FDA's requiring placebo-controlled trials that are randomized, which means that patients who enter the clinical trials either get a sugar pill or the active drug, and they don't know what they're getting.

Gigot: Is that fair for cancer patients? Somebody who's really sick?

Gottlieb: I think in a lot of cases it's probably not fair, and it does test ethical boundaries. But particularly with the immunotherapies, it could be the wrong paradigm for testing drugs, because the immunotherapies might well work better in people who have earlier-stage cancers, who still have immune systems that are capable of being boosted, but the placebo-controlled trials--when you run a placebo-controlled trial, it's often the case that people with early-stage cancers don't want to enter the trials, and so you're forced to have to recruit people who have very late-stage cancers, and 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 the fallout from the Vioxx controversy, where that drug--it was a pain killer--was pulled from the market after it was found to increase the risk of heart attack in some patients. There was a big political flare-up over that. A lot of people said the FDA moved too fast to approve it. Are we seeing this as a counterreaction, a blowback against that political uproar?

Gottlieb: Well, I don't think you've 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 certainty of effectiveness of drugs that are approved in the cancer space. Usually safety questions aren't the issue when 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's caused to happen inside the agency is that it's given a little bit more voice to people who might have had a minority point of view inside the agency, and that could be affecting some of these reviews, where people who otherwise might not have been in the majority in terms of their view of the science and their opinion are now able to have more sway in the process.

Gigot: But just so I understand, you're saying there is a difference of opinion among cancer doctors and oncologists about whether or not the FDA is now getting too worried about these safety and efficacy concerns and should perhaps move faster to approve these new kinds of--let's face it, exciting kinds of therapy.

Gottlieb: Well, there's certainly a split in the cancer community. When you talk to cancer experts, you talk to people at the NCI, some people have misgivings about the effort that's under way--and it really is an effort. I think it's a conscious effort. And other people support it. Other people say that 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. So there is a split in the cancer community, no question, among leading cancer--

Gigot: Where do you come down?

Gottlieb: Well, I think we should be able to tolerate a little more uncertainty when it comes to these kinds of drugs. And I think you're dealing with a therapeutic space where the clinicians are very good at reading the literature and very good at explaining things to their patients. And they should shall given the opportunity to try out new drugs.

And it's also the case, Paul, that cancer patients don't just choose medications based on effectiveness but sometimes on the side-effect profile. And in fact, there was a case with the drug Zarnestra, that 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 that 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 that's a decision patients ought to be able to make.

Gigot: All right, I agree with you. Patients should be in on that decision.

All right, thank you, Scott Gottlieb.

When we 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 Capitol Hill. Plus, the legacy of Jerry Falwell. He was the face 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.

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've been paying attention to this legislation. Getting attacked by the right and left already.

Mr. Riley: Yes.

Gigot: Big picture, do you think this is an improvement on current law?

Mr. Riley: In some respects yes, and in other respects no, which explains attacks from all sides of the political--both ends of the political spectrum.

The parts of the bill dealing with what to do with the 12 million illegals already in the country I think are very reasonable, very 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 place, or that is proposed. That, I think, could use some tinkering. Is that going to be enforceable? And that's important. Because this is really about making sure that going forward, U.S. businesses have access to the labor they need.

Gigot: Well, Naomi, what about this charge from the right that this is amnesty for the illegals who are already here because they get to stay here even after they've broken the law?

Ms. Riley: I think the amnesty charge is just bunk. I mean, they have to pay back taxes. They have to pay a fee to stay.

Gigot: Five thousand bucks.

Ms. Riley: Yeah, I mean, that's not nothing when you're working in the back of a restaurant, I will tell you that. You can't get that on tips very quickly.

You know, I think one other problem with the bill, which is--it's a principle question. They're emphasizing more--they're 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 I think 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 Ph.D.s. And I think you can't predict what the future is going to be just because you bring a low-skilled worker here.

Pollock: Our current immigration laws are so silly and impractical, it's hard to get very outraged about the fact that people are breaking them. I am about as outraged about that as when people drove over 55 miles an hour. It's just--who cares?

Fund: Well, 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's that obstacle.

Then, partisanship. A lot of Republicans fear the Democrats are going to pull the rug out from under them at the last minute after they have taken a lot of political risk to support this. A lot of Democrats simply want to have this as a 2008 election issue. Both parties completely distrust the other.

Gigot: Well, but Ted Kennedy, though, is a spokesman for the Democratic side. He can bring a lot of Democratic votes in the Senate. And I'm told that this is going to get as many as--may get 70, 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.

Mr. Riley: But Bush is very much for it and he said--

Fund: And he has how much political capital?

Mr. Riley: True. But he said I am very anxious to get this done as soon as possible. I thank Republicans want to get past this issue, because it's so dividing the party, and they don't want that.

Gigot: It would be good for the Republican Party, I think, to get this off the table and settled before the election of 2008, because you can see already it's dividing the Republicans up in the primaries. I mean, 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 has opposed it already, and Rudy Giuliani, sitting right on the fence--he couldn't even decide what to say about it.

Fund: And I'll predict that Rudy Giuliani eventually comes out against this bill, largely for political reasons.

Gigot: All right. So, I mean, where do you think, John? Is this thing--I mean, obviously 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: I think it can pass the Senate, but remember, this is a thousand-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: The Senate, right--but I think that will create a lot of suspicion among the general public that somebody's trying to pull a fast one here. So I think it can pass the Senate. The House is actually going to be pretty tough.

Gigot: All right, that's it.

When we come back, the Falwell legacy. How the founder of the Moral Majority changed American politics.

John, how important a political figure was Falwell?

Fund: Very important. People forget that the Moral Majority started because the Carter administers was harassing Christian schools, and evangelicals thought, We've been out of politics but now we have to get in it. So Falwell mobilized that resentment against the federal government into an enormous voter registration campaign that helped Ronald Reagan get elected. I think over time, though, Falwell lost influence.

Now evangelicals have become much more sophisticated politically. If you look at the polls, Rudy Giuliani probably is tied with Fred Thompson for support among 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 in the '90s kind of a caricature of what liberals thought an evangelical should be, Naomi. That's what I always thought.

Ms. Riley: Yeah, well, he was. I think it was 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, things like that.

Ms. Riley: Absolutely.

Pollock: And people 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, and that's another phenomenon.

Ms. Riley: Right, exactly.

Mr. Riley: And at the same time, I think a lot of his sympathizers today want to sort of airbrush some of 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.

Ms. Riley: It wasn't just the public-school issue. I mean, it really was abortion also that really rallied the evangelicals. And I think that's important to remember because that is a legacy obviously that remains a huge issue for the religious right today.

Fund: The biggest legacy he has, of course, is Liberty University, which is a top-notch school, which is producing all kinds of very important--

Gigot: I want to get to 2008 though, Naomi. You recently talked to Richard Land, who's head of the Southern Baptist Convention and a very key figure in the evangelical political circles. What is he saying about the 2008 election for evangelicals?

Ms. Riley: Well, as is his job, he insists of course that evangelicals have a lot of influence. And I do believe him. I don't think that Republicans can win without evangelicals. But that being said, they're splitting their vote, as John said. You know, they're supporting all sorts of different primary candidates, and that's going to really dilute their influence over time in the Republican primary.

And then you see, whichever one of these candidates wins--if Rudy wins, you could see a lot of evangelicals staying home; if Romney wins, you could 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 really do want to win in Iraq, more than most other Americans actually. And they might be willing to swallow their pride and go with someone like Rudy.

Gigot: Well, wait a minute. 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 even Hillary Clinton, if she appears in church enough times, gets some of those evangelical voters to vote Democratic?

Fund: The Democratic candidate, whoever it's going to be, will talk about faith and their attendance in church more than anyone can imagine. And I think evangelicals will cast about 30% of their votes for Democratic candidates. That's why it's very important for the Republicans who want to win, they have to have a candidate who can unite all strands of the Republican coalition, including evangelicals.

Ms. 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 that blacks are taken advantage of by the Democratic Party. That is, that the Republicans should not count on their votes. And that's an important message.

Gigot: But would he want to elect Hillary Clinton? I mean, he knows that the Supreme Court nominees that Hillary Clinton would make, or a Barack Obama would make, are not going to be anything close to the kind he's had under George W. Bush and may not get under a John McCain or Rudy Giuliani.

Ms. Riley: No, and that's fair. And as John said, I think they are pretty savvy, and they know what the result is if they stay home, and I don't think evangelicals want to be faced with Hillary.

Gigot: Some of this right now is posturing, trying to see if they can get their favored candidate to win?

Ms. Riley: Yes, who might be Fred Thompson, so they have to wait until he declares before they say he's their favorite candidate.

Mr. Riley: Which tells you a lot about their continued influence today, that none of the front-runners would be their ideal candidate.

Gigot: All right, we have to take one more break. When we come back, our "Hits and Misses" of the week

Item one, a hit for outgoing British Prime Minister Tony Blair, loyal until the end.

Pollock: Yes, big kudos to Tony Blair. He could have made himself popular at home, where the Iraq war is unpopular, by saying, like so many U.S. Democrats have, that he was somehow 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 that 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, Paul, as a trial lawyer. After he was Democratic vice presidential candidate in 2004, even he needed a part-time job. So he went to work for a hedge fund, Fortress Investments, and he earned $480,000 last year for part-time work a few days a week--a month. It turns out Fortress Investments is incorporated in the Cayman Islands, which is the ultimate offshore tax haven.

Now John Edwards has campaigned his entire political life against these awful offshore tax havens where people try to pay less taxes. Now he says, Well, I'm still against the hedge funds. And I still will try to abolish their of-shore tax havens if I become president, but until then, I guess he's going to collect all those tax-free checks.

Gigot: All right.

And a hit to the Geico cavemen. Naomi?

Ms. Riley: Well, the new fall lineups came out this week and it turns out the Geico cavemen, that is the cavemen in Geico commercials, are going to get their own sitcom. I think this is a great hit.

You see, the Geico cavemen--the whole premise of the show is going to be how difficult it is to a caveman in America today. And the commercials were really about how cavemen are probably the last people in America you can actually say something without offending. But it turns out of course you have offended them. And that's the whole premise of the show. And I think it is fascinating that people have really glommed on to this kind of political incorrectness that, Finally, we've found someone we can say something mean about, and it's just that they happen to have died a few thousand years ago.

Pollock: And so it's safe.

Gigot: And 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. Yes, 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 anticorruption agenda offended Europeans and bank staff, who didn't want to be held accountable. Wolfowitz emerges with his reputation intact, 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, and we hope to see you right here next week.