The NewsHour with Jim Lehrer

JIM LEHRER: Good evening. I'm Jim Lehrer. On the NewsHour tonight: Our summary of today's news; then, perspective on the raging political crisis in Ukraine; a debate over the way the FDA clears new drugs for the market; a Ken Auletta look at today's announced departure of Dan Rather from the CBS anchor chair; and a report from Minnesota on teaching sexual abstinence in the schools.

NEWS SUMMARY

JIM LEHRER: The U.S. Military launched a new offensive today in Iraq, aimed at rooting out more insurgents. Roughly 5,000 American, British and Iraqi forces raided a series of towns south of Baghdad. They captured at least 75 suspects. In recent months, rebel attacks in that area had effectively blocked travel between Baghdad and southern Iraq. Also today, gunman killed a Sunni Muslim cleric as he left a mosque north of Baghdad. He was part of a group that's called for a boycott of January's elections. Another Sunni cleric was killed yesterday in a similar attack. Iraq's electoral commission today approved 156 political parties for the January election. They include the parties of Prime Minister Allawi and President al-Yawer, among others. And in Egypt, delegates from 20 countries voiced support for elections in Iraq on Jan. 30. U.S. Secretary of State Powell said the leaders were committed to going ahead with that plan.

COLIN POWELL: No delegation leader came to me in the course of the last 24 hours-- and I'm going to spend more time with them this afternoon-- to say to me, you know, you really ought to work with the Iraqis to delay the elections. Everybody I think realizes the importance of moving forward. And that's what the Iraqi government and their electoral commission is committed to do.

JIM LEHRER: The conference nations also urged Iraq to deal resolutely with terrorism, but avoid excessive force. They did not call for setting the deadline for U.S. troops to leave Iraq. France and some Arab nations had wanted such a deadline. There were new concerns about humanitarian needs in Iraq today. The U.N. children's agency reported violence across the country has crippled relief work. It said the result is a sharp increase in malnutrition among Iraqi children. And in Fallujah, security concerns forced a Red Crescent convoy to turn back to Baghdad before unloading its supplies. Some 200,000 protesters rallied in Ukraine's capital for a second day today. They claimed last weekend's presidential runoff was rigged. Official returns showed the country's prime minister defeated the challenger, Viktor Yushchenko. He claimed fraud, and today, he took a symbolic oath of office. We'll have more on this story right after the News Summary. Three U.N. workers in Afghanistan were released unharmed overnight. They had been kidnapped in Kabul almost a month ago. The kidnappers demanded the release of Taliban prisoners. But today, the Afghan interior minister insisted the government made no deal to free the hostages. Back in this country, CBS News anchorman Dan Rather announced today he is stepping down next March, after 24 years. He'll continue working on "60 Minutes." His successor as anchor was not named. Rather said in a statement he's always been an investigative reporter at heart. He said he wants to return to that full-time. In September he came under fire for his 60 Minutes report that questioned President Bush's National Guard service. It cited documents that appeared to be forgeries. Today Rather said his decision to step down is unrelated to that issue. We'll have more on the story later in the program. Media giant Viacom agreed today to pay $3.5 million to settle federal indecency complaints. It was one of the largest fines in the history of the Federal Communications Commission. It covered incidents involving radio disc jockey Howard Stern and others. One of President Bush's top economic advisers is leaving. It was widely reported today that Stephen Friedman will step down as director of the National Economic Council. Friedman had been a top executive at the investment firm Goldman Sachs before he took the White House job two years ago. On Wall Street today, the Dow Jones Industrial Average gained three points to close above 10,492. The NASDAQ fell nearly one point to close at 2084. And that's it for the News Summary tonight. Now it's on to the troubles in Ukraine, the FDA debate, the Rather withdrawal, and abstinence instruction.

FOCUS - ELECTION PROTEST

JIM LEHRER: The power struggle in the Eastern European nation of Ukraine. We start with some background from Jonathan Miller of Independent Television News.

JONATHAN MILLER: In downtown Kiev there's a whiff of revolution in the freezing air. In the thousands, tens of thousands, they marched towards Independence Square to join the disgruntled masses who had braved sub-zero temperatures throughout the night, in protest of an election which all except the winners say was rigged. Shades of Prague, Belgrade, Tiblisi? To veterans of past velvet revolutions, it's eerily familiar. "Yushchenko, Viktor Yushchenko," they say, "cheated us for presidency by his political nemesis, Viktor Yanukovic. The two Viktors. But only one can win. Viktor Yushchenko told the crowd the people's will cannot be broken; the people's vote cannot be stolen.

VIKTOR YUSHCHENKO (Translated): You are the heroes. You are the heroes of Ukraine. You are carrying on your shoulders what will become-- maybe tomorrow, maybe next week, maybe next year or in many years to come-- the future of Ukraine. (Crowd shouting)

JONATHAN MILLER: With that, he told them to march on parliament, where inside his political supporters were decrying what independent observers agree was fraud, a fraud which gave Yanukovic, the outgoing president's designated heir, a narrow victory despite exit polls which gave Yushchenko, leader of the liberal opposition, a clear lead.

SPOKESMAN (Translated): The parliamentary speaker said we're sliding towards the abyss.

JONATHAN MILLER: Yushchenko, a former prime minister himself, later told parliament Ukraine was now on the brink of civil war. In a provocative act, Yushchenko placed his hand on a bible and read the oath of office before opening a window and addressing his supporters.

YUSHCHENKO (Translated): Yanukovich addressed the nation on a state TV last night. He hasn't declared victory yet, but he's already being congratulated by his most important backer, President Putin of Russia. I don't want you to feel like losers. We all won. And we will win more if we keep things peaceful in Ukraine.

JONATHAN MILLER: But democracy was not the winner here. It's been a dirty campaign with dirty tricks aplenty. Victor Yushchenko alleges that twice his political enemies tried to kill him. He claims to have been poisoned in September. This is him before it happened; now, his face is hideously scarred. The government said he must have eaten some bad sushi. The stakes are high. Politically, Ukraine is split down the middle-- between those looking East to Russia, and those who look to Europe. Yanukovic derives his support from the East, although turnout was improbably high, at 96 percent in places, it does seem he'd easily have won. Yushchenko's support is in the more prosperous West. That's why what's happening in Kiev is rather different to what happened in Tiblisi, Georgia, exactly a year ago today, when opposition supporters stormed parliament and ousted the deeply unpopular President Eduard Shevardnadze. Today his successor commemorated his Rose Revolution, an anniversary given added poignancy by events in Ukraine.

JIM LEHRER: For more on the situation in the Ukraine, here Michael McFaul, a senior associate at the Carnegie Endowment for International Peace and associate professor at Stanford University.

How would you describe the situation or what's happening right now in Ukraine?

MICHAEL McFAUL: Well, Jim, I teach a course on revolutions back at Stanford. And the definition of a revolution is when two leaders backed by two alternative organizations each claim to be the sovereign authority of one country. And that's what you have in Ukraine today. We just saw it on the tape where Mr. Yushchenko went before a parliament, a rump parliament, the other folks were not there. And he took the oath of office for the presidency. Mr. Yanukovich, the prime minister has been declared the president... presidential winner by the other side. It's a revolutionary situation. I think it's very, very tense right now.

JIM LEHRER: Is it proper, as was done in the tape, to compare it with prior eastern European revolutions, particularly toward the end of the Cold War?

MICHAEL McFAUL: Well, yes and no. If you think about Poland in 1989 and the round table and the elections or Prague in 1989, what was very different about that situation versus Ukraine today is it was overwhelmingly on the side of the Democrats or the opposition -- 85 percent, 89 percent. There was no... nothing there for the incumbents in power. Ukraine is different. Even by the exit polls run by organizations that are sympathetic to Mr. Yushchenko, 40 some percent voted for Mr. Yanukovich so the balance of power here is much more equally distributed. And that to me means that both sides might think they have a chance to fight to win.

JIM LEHRER: What do you make of the widespread charges that the election was in fact rigged?

MICHAEL McFAUL: Oh, absolutely. I mean....

JIM LEHRER: Absolutely?

MICHAEL McFAUL: It's just overwhelming.

JIM LEHRER: How? How do they rig it?

MICHAEL McFAUL: Well, they run the state. They can stuff the boxes. I mean, you have 99 percent turnout in the region where Mr. Yanukovich is from. That never happens anywhere. Some precincts are reporting over 100 percent. That can't physically happen. I don't think there's any doubts really frankly on both sides. We knew this was going to happen. But it was done in a very rather elaborate and elegant way compared to say, Georgia that was mentioned in the tape a year ago where it was done in a very haphazard way. They changed the numbers. You know, at one time he's up 20 points and down 20 points later. This happened incrementally hour by hour where Mr. Yanukovich gradually won and the spread is only 3 percent. And that makes it ambiguous because the exit polls don't quite capture it, the parallel vote tabulations -- these are technologies we use to monitor elections -- don't quite capture it. And very interesting and perhaps for the first time in history the Russians got involved. So the Russians sent their electoral monitors. They said, no, those westerners....

JIM LEHRER: Our guy won.

MICHAEL McFAUL: They said it was fair. Their exit poll showed that their guy won. That's a very different thing. It muddied the water here.

JIM LEHRER: When you said we knew this was going to happen? What do you mean? The outside world knew they were going to rig this election?

MICHAEL McFAUL: Yeah. I mean, this has been in the cards for a long time. The opposition has been preparing for it for a long time. Mr. Yanukovich and his supporter President Kuchma has basically been preparing for this for a long time. And, again because it's in the gap, right, it's not 75-25, it's 55- 45, they think they can get away with it.

JIM LEHRER: All right, now, the story about the alleged poisoning of Yushchenko and the deformed face, what is really known about that?

MICHAEL McFAUL: Well, it's been disputed. He went to Austria and some doctors said it didn't happen. Then they said it did happen. My own assessment of it is that it probably did happen; something did happen. This is a rough place.

JIM LEHRER: You mean it probably did happen, that somebody within the government opposed to this guy poisoned him?

MICHAEL McFAUL: Yes, I think that happened.

JIM LEHRER: And he went to Austria and was treated. He went there twice according to the wire stories that I read today and his face... and this poisoning caused his face to be deformed?

MICHAEL McFAUL: I think that's right. And I think a picture tells a thousand words. He wouldn't do that to himself. And let's remember who this guy is. He's not some firebrand revolutionary. This is a mild mannered central banker that has been radicalized because of the politics in Ukraine. He doesn't want revolution. He's been forced to be the leader of this opposition. So I find it hard to believe that he would do this to himself.

JIM LEHRER: But tell us more about this. He's described as a liberal. That's... what's that mean in Ukrainian terms?

MICHAEL McFAUL: Well, in Ukraine and Russia -- that region -- liberal means he supports economic reforms, he wants Ukraine to be part of the West. He would like to see Ukraine integrate some day into the European Union and perhaps even NATO. But this really wasn't an election about liberal versus conservative and it's not about liberal versus communist say ten years ago had we been talking about Ukraine. This is really about a corrupt regime. President Kuchma, and his hand- picked successor, this guy....

JIM LEHRER: Kuchma wanted to give it over to this guy.

MICHAEL McFAUL: That's right. And kind of wanted to do....

JIM LEHRER: And say watch me do it in a way.

MICHAEL McFAUL: And I challenge you to not let me do it. Yushchenko has organized the opposition, again as the map really clearly showed, it's red state, blue state in America, well, here it is, it's very polarized in Ukraine as well. And the West supports Yushchenko. The East supports Mr. Yanukovich.

JIM LEHRER: Why is Russia staying with the government, staying with Kuchma and his chosen one?

MICHAEL McFAUL: Well, because Ukraine is ethnically divided too. And when you saw that blue part of Ukraine, the blue part of Ukraine is pre-predominantly Russian, ethnically Russian and Russian speaking so they see Yushchenko and they have branded him as an American patsy. His wife is an American. They see this as if it goes to Yushchenko, NATO and the West creeps into our sphere of influence. Let's remember the Kiev roost, that's where Russia started. This is for them part of what they think as their home land. So they're fighting very hard and Putin himself has been very intimately involved in this election.

JIM LEHRER: In what way?

MICHAEL McFAUL: Well, he went and campaigned for three days for Mr. Yanukovich during the first round. He has sent electoral public relations guys have been working there, by one count, 250 million dollars of Russian money was spent for Mr. Yanukovich. And he very quickly, even before the official results were announced, congratulated president Yanukovich in his victory.

JIM LEHRER: Tell us more about, you say this liberal leader began as a banker. Tell us more about him. Where was he educated and all of that? What do we need to know about this guy?

MICHAEL McFAUL: Well, he comes from what I would call a kind of professional class of post Soviet bureaucrats that were brought up and brought into the government. Remember guys like Yegor Gaidar, the first prime minister in Russia who came in a technocrat to do economic reform. That's what Yushchenko is. He served in the government. He served under Mr. Kuchma for a while and then was ousted and became the kind of point person, if you will, for the opposition, reluctantly so. I mean, my friends in the Ukrainian opposition movement have been frustrated with him, that he is not a firebrand revolutionary. He is not, for instance like this guy, Saakashvili, the president of Georgia who in a moment like this immediately seized the day and kind of charismatic big guy. No, that's not him. I think he would be happy being the central banker of Ukraine but circumstances made him serve a different role.

JIM LEHRER: Now, you know about Ukraine. You've been studying that part of the world for years. But the rest of us have not. Explain why this is important, if at all, to the rest of the world.

MICHAEL McFAUL: Well, President Bush himself has said time and time again that he considers his mission in the world to promote freedom, democracy, liberty. Here it is right before your very eyes. In a country, not some insignificant country, but in the heart of Europe, 50 million people where you've had an election it's been falsified; the thugs have taken over; and now here is the moment of truth. Are we serious about this or not? Secondly....

JIM LEHRER: But that's a process stake we have, right?

MICHAEL McFAUL: Right.

JIM LEHRER: Philosophical stake.

MICHAEL McFAUL: Right, that's a philosophical stake but we have to side with those that are on the side of democracy. But the second issue is this, that when you have two sides that say we won the right to lead this country, that is a very dangerous situation that could... you know, my greatest fear is that some idiot-- and it will be an idiot-- who will lash out at the other side. I don't know if it will be a government official or somebody on Yushchenko's side and somebody will die. That happens in these situations. The other side will say they provoked us; now we are in the midst....

JIM LEHRER: A civil war possible.

MICHAEL McFAUL: Down the road, civil war, yes.

JIM LEHRER: Are there instruments within the government that could resolve this peacefully? Are the tools there for it to work?

MICHAEL McFAUL: No. There isn't. I mean, we've got to the impasse now. They've gone to the streets. They're camped out on the streets. The government said we've won. And it seems like Mr. Yanukovich and Kuchma, the president, their strategy is just going to be to gut it out, to let the protesters camp out there in very cold winter that we're now moving into and hope that gradually it will dissipate.

JIM LEHRER: Somebody has to blink or there's going to be war.

MICHAEL McFAUL: Yes, I think that's right.

JIM LEHRER: Michael McFaul, thank you very much.

MICHAEL McFAUL: Thank you.

FOCUS - DRUG SAFETY

JIM LEHRER: Still to come on the NewsHour tonight: Testing new drugs; the going of Dan Rather; and teaching abstinence. Susan Dentzer of our health unit begins the drugs story.

SEN. CHARLES GRASSLEY: One of my concerns is that the FDA has a relationship with drug companies that is far too cozy.

SUSAN DENTZER: That criticism, voiced by Iowa Republican Sen. Charles Grassley, has the ring of familiarity at the Food & Drug Administration. But officials there also encounter the opposite critique, that FDA is the pharmaceutical industry's biggest speed bump in marketing new drugs. That view, too, emerged at a Senate hearing last week from another Republican, Oklahoma's Don Nickles.

SEN. DON NICKLES: Maybe one of the results, if we give FDA a real hard time they're going to be real cautious and all of a sudden the time length for approval of drugs is going to get longer and drugs are going to be more expensive. There's lives at stake on both ends of the drug-approval process.

SUSAN DENTZER: The FDA has a dual role in that complex process, approving new drugs for sale, then overseeing their safety. As a result, the agency has come under harsh scrutiny of late. Earlier this year, FDA was caught up in controversy over an apparent link between antidepressants and suicidal thinking and behavior in some teens and children. Some analysts accused FDA of downplaying some of its scientists' concerns, and moving too slowly to warn about the drugs' risks. Now the FDA is under fire for its role in monitoring the blockbuster painkiller VIOXX. The drug was pulled off the market in September by its manufacturer, Merck. The company's own study showed VIOXX doubled the risk of heart attacks and strokes. FDA Safety Officer David Graham spoke at last week's hearing.

DR. DAVID GRAHAM: I would argue that the FDA, as currently configured, is incapable of protecting America against another VIOXX. Simply put, FDA and the Center for Drug Evaluation and Research are broken.

SUSAN DENTZER: Other FDA officials have taken strong issue with graham's criticisms. Dr. Sandra Kweder heads FDA's Office of New Drugs.

DR. SANDRA KWEDER: That is not the FDA I know. There was a drug safety reviewer on VIOXX, for example, that worked on a daily basis combing through adverse event reports and working with the new drug review division on this drug, just like we have for every drug.

SUSAN DENTZER: But many at the FDA agree that there are problems, stemming in part from the agency's structure. One issue is figuring out how to forge consensus among the frequently dissenting scientific views within FDA Kweder says that process is being addressed.

DR. SANDRA KWEDER: Disagreement is part of science. However, we will implement the system in a more formal manner to absolutely ensure that scientists who don't believe they are being heard have an extra measure to ensure that.

SUSAN DENTZER: A second concern is whether the process of approving drugs takes precedence over the process of overseeing their safety. Critics like Graham say it does.

DR. DAVID GRAHAM: The organizational structure within CDER is entirely geared towards the review and approval of new drugs. When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat. They approved the drug, so there can't possibly be anything wrong with it. This is an inherent conflict of interest.

SUSAN DENTZER: This week, an editorial in the Journal of the American Medical Association called for a radical solution: Setting up an new drug safety board that would operate outside the FDA And FDA itself has called for an independent study of its drug safety oversight.

JIM LEHRER: Ray Suarez takes it from there.

RAY SUAREZ: Is the FDA Doing a good job of protecting the public while approving new drugs? And what changes can be made to improve the system? We get two views. Dr. Jerry Avorn is an associate professor of medicine at Harvard Medical School, and an international expert on medications. He is the author of a new book, "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs." And Dr. Brian Strom is the director of the Center for Clinical Epidemiology at the University of Pennsylvania School of Medicine. He is an expert in the field, and has sat on several committees advising the FDA.

Dr. Avorn, is the FDA drug- screening machinery working properly? Are we getting safe and effective drugs to the public and protecting the public from unsafe ones?

DR. JERRY AVORN: I think it's fair to say in light of both the VIOXX experience and also the experience we've had with other drugs in the recent past that, no, the system is not working well at you will.

RAY SUAREZ: And what would you say is the cause of that? What is flawed about how the process is working that leads you to something like what you refer to, the VIOXX incident?

DR. JERRY AVORN: Well, as the piece just indicated, there's an enormous focus within FDA about approving drugs quickly and getting them on to market. And that's okay if it's done well. But then the attention of the FDA really drops off. And the vigilance disappears when it comes to requiring and analyzing the data that we need to be able to learn about the safety of the drugs once they're in widespread use.

RAY SUAREZ: Dr. Strom, is the FDA doing its job properly, getting safe and effective drugs to the public and protecting it from unsafe ones?

DR. BRIAN STROM: I think given the circumstances FDA operates under it does a remarkably good job. Clearly there could be improvements. Things could be better. I guess we'll talk later about it. But I think it's very important that the public realize that a safety problem like VIOXX doesn't necessarily mean the system is broken. Every drug has toxicities. Every drug has safely safety problems inherent in it. We make as a society a risk- benefit judgment about whether or not to have a drug available. As a physician I make a risk-benefit judgment about whether or not to prescribe a drug for a patient, knowing its toxicity knowing its potential benefit. All drugs have safety problems.

RAY SUAREZ: Well, at the beginning of your answer you said under the circumstances. What circumstances does the FDA work under that limits their ability to regulate what drugs get to the public?

DR. BRIAN STROM: Oh, I think there are a number of plays and I would love to see the Office of Drug Safety greatly strengthened. They have limited resources and limited staffing. They have limited regulatory ability. When a company, for example, commits to be a post marketing surveillance study, the FDA has a very limited ability to enforce that commitment afterwards. And those are all powers that FDA needs to have in order to be able to properly regulate.

RAY SUAREZ: Wasn't that the trade-off during the 1990s, making the system work more quickly on the front end and putting more emphasis on the post market surveillance?

DR. BRIAN STROM: I think that's exactly the trade-off that was made. I think that there was some effort made with that in order to strengthen the back end, as you refer to it, after the drug is marketed. I think there's a lot more effort that needs to be done there in order to strengthen that even better. Once again I think people at FDA do an enormously good job but I think a better job could be done if they were resourced even better and given greater powers accordingly.

RAY SUAREZ: Well, Dr. Avorn, where did those pressures come up from to speed up the approval process on the front end in order to put more emphasis on how the drug works once it's in general circulation?

DR. JERRY AVORN: Well clearly it's greatly in the interest of the drug manufacturers to have drugs approved speedily. And certainly if it's an important break-through product, we want to have the drug approved speedily to get it to the people. On the other hand, when the user fee act was first put in place in which the companies pay FDA to review their own products, the original plan was not one dime of that could be looking at safety problems that came up afterwards. It was all about speeding up and not enough about catching the problems once they were discovered when drug was in the marketplace and as Dr. Strom indicates, we currently do have a kind of atrophied component of post marketing surveillance.

RAY SUAREZ: But you talked briefly about that model of using the user fees. That is, having the pharmaceutical companies themselves pay for their own regulation. Does this set up two opposing forces that just aren't reconciling properly?

DR. JERRY AVORN: Well, it's an odd way to fund a regulatory structure that you have the agency paid for by the industry that it's regulating. The argument was that this would save money for the government but that's awfully short-sighted because it's at a great cost to have that kind of culture within the FDA that our salaries are eventually paid by the drug manufacturers. That was probably a very short- sighted way to save money for the government.

RAY SUAREZ: Dr. Strom, how does that work in your view? Is it a viable model?

DR. BRIAN STROM: I certainly agree with Dr. Avorn, it is an odd way to fund it. I am much less concerned about that conflict of interest than by the atrophy of the post marketing surveillance part. The nature of the User Fee Act, as Dr. Avorn mentioned, it initially forbade FDA... FDA was not allowed to use any of those funds after marketing which obviously doesn't make any sense. If you're going to market drugs earlier, you want to strengthen the post marketing surveillance. I think there are people who are concerned about having FDA funded by these user fees. It is an odd system. On the other hand, I have certainly never seen any problem that has been generated with it. I've worked a lot with industry. I've work a lot with FDA; I can tell you FDA can be very stern with industry and industry can be very scared of FDA in response. I certainly see no evidence of coziness and no change that came about because of the User Fee Act. I think the big change was that the new drug branch got expanded and the post marketing surveillance branch did not.

RAY SUAREZ: Well in our taped report, Susan Dentzer featured the testimony of Dr. David Graham, I think arguably blockbuster testimony. He named several drugs by name, talked about the potential for other VIOXX's out there. Dr. Strom, what do you think? Are there?

DR. BRIAN STROM: I think there is guaranteed to be other VIOXX's out there. I think we don't do the public a service when we focus on one drug or five drugs and say they have problems that they have safety issues. The public has to understand that all drugs have safety issues. No drug is safe whether you're talking about a prescription drug or over the counter drug or certainly an herbal drug that people take on their own. We know they have toxicities and when you're dealing with a new drug, we know they have toxicities that are yet undiscovered. Fully 51 percent of drugs have major new safety problems discovered after the drugs are marketed. Those are the ones we know about. To me the VIOXX's are a success not a failure. Those are the ones we found out about. I worry more about the ones we haven't found out about.

RAY SUAREZ: Dr. Avorn, what about that, the idea of a discovery like that of VIOXX shows that the machinery as set up is a viable one -- that the system works?

DR. JERRY AVORN: I couldn't disagree more. I think we have very ample evidence that there were worries about VIOXX going back to 1999 and 2000 and the FDA failed grotesquely in not demanding that the manufacturer look into those questions the very moment they were first raised. Instead years and years and years went by; millions of people took the drug. FDA did not require Merck to do the studies that it needed to require them to do in the year 2000 and 2001. Merck failed to do those studies on its own. And I don't think that demonstrates the works. I think it demonstrates some real problems with the system.

RAY SUAREZ: What do you do now, Dr. Avorn? Does this call for a major overhaul of the methods we use to approve drugs for the market?

DR. JERRY AVORN: I'm afraid it does. There have been a number of cases over the last couple of years. VIOXX is not an anomaly. In powerful medicines I talk about three or four or five instances in which we discover that there were major problems with the drug years after in some cases the Europeans had taken the drug off the market. We need to do a much different job and perhaps we can't have it within the same agency. Maybe we do need to have a separate group approving a drug and another group saying, let's look at the safety so that there isn't this conflict within the same agency.

RAY SUAREZ: And how about you, Dr. Strom, the idea that has been suggested to take the approval process out of the hands or big parts of it out of the hands of FDA, what do you think of that?

DR. BRIAN STROM: I think it would be useful to have an agency outside of FDA but not the approval process. I would suggest that there really are four changes that are needed. One of them is that the Office of Drug Safety needs to be strengthened, FDA needs to be strengthened. It needs to be given more regulatory authority after drugs are marketed. The second is I would recommend that for the first few years after marketing we have a conditional approval process; that the companies have to come back to FDA after those few years with additional safety information in order to get an unconditional approval. Third, I would recommend that during those three years direct consumer advertising should not be allowed. Part of the problem is Congress has unleashed the marketing arms of the drug companies to grossly overuse drugs. When a drug is new, almost surely there are still safety problems as yet unknown. The drug should only be used by people who really need the drug. The fourth thing I would recommend is we do need an external body. I would not remove from FDA the regulatory authority. I think the external body needs to have a complementary role. One of them is basically an autopsy type of role, a post mortem role; when there's a problem look back at the problem and say, could we have done anything different? The other role it would have is a whole set of roles that FDA doesn't and can't now do and shouldn't now do, like educating the public, like educating physicians, not to overuse drugs not to overuse new drugs. The biggest problem we have in this country is not the rare adverse reaction to the new drug. The biggest problem we have is inappropriate use of drugs. Whether it's new drugs that become blockbusters prematurely and have side effects we haven't discovered or old drugs that we know very well what the toxicities are but are killing thousands or tens of thousands of patients because we're not using them correctly.

RAY SUAREZ: Let me turn to Dr. Avorn and see if you heard anything you like in that list of suggestions.

DR. JERRY AVORN: I think there's a number. Things that Dr. Strom said that make a great deal of sense, and we clearly do need to have a better way of doing the so-called autopsies on drugs; on the other hand I think if we did a better job of approving drugs and learning more about them before they were marketed, we would perhaps not need to do as many autopsies on drugs or on patients. We need to figure out a mechanism for getting better data before the drug is approved. Right now a company has to demonstrate only that its drug is better than a sugar pill in many cases for it to be marketed. I as a doctor don't want to know is it better than a sugar pill; I want to know is it better than what I could otherwise used. And that is not at all part of FDA's mandate. We need that kind of study. Industry will not do it voluntarily because very often the drugs are not much better than the drugs we have on the market.

RAY SUAREZ: What about Dr. Strom's suggestion that there be something in between full general release and test release? He posited this idea that a drug could go into limited release and we could learn more... even more about it before it goes into this fullest final form?

DR. JERRY AVORN: I think that makes a great deal of sense. Medicine is all about learning. And we're never going to know everything we need to know as Dr. Strom said when a drug is first released even if the studies are adequate, as they are not currently. So we do need this period of learning. That's exactly the period when we don't want to have direct consumer ads saying everybody on the planet should be taking this.

RAY SUAREZ: Dr. Avorn, Dr. Strom, gentlemen, thank you both.

FOCUS - ANCHORS AWAY

JIM LEHRER: Dan Rather's big announcement: Media correspondent Terence Smith has our story.

TERENCE SMITH: In his announcement, Dan Rather said his last night in the anchor chair at the CBS Evening News would be March 9 of next year, 24 years to the day after he took over from the retiring Walter Cronkite. Some months ago, NBC announced that Tom Brokaw, the anchor of the NBC Nightly News, will step down Dec. 1, after a 22-year run. He will be succeeded by Brian Williams. Joining me now to discuss these changes is Ken Auletta, who chronicles the media industry for the New Yorker. Ken, welcome.

KEN AULETTA: Thanks, Terry.

TERENCE SMITH: This Rather announcement and its timing, what do you make of it?

KEN AULETTA: Well, I mean, obviously if you're Dan Rather you're in your 24th year of being an anchor, 50th year of being a reporter. You have this report coming out probably in a couple weeks and you're concerned that it's going to cast a pall after your career, a cloud over your reputation. You say let me get ahead of the cycle here and let me announce my departure on my terms and try and avoid that cloud. Now, I don't know what that report is going to say and I don't think Dan Rather knows what that report is going to say but this is his way, I think, of trying to control his own exit.

TERENCE SMITH: All right. This report that you're referring to is an investigation of the case involving the documents on President Bush's National Guard Service. There's a two-man panel looking into it, and their report is expected soon. So to some degree you see this as anticipatory for that?

KEN AULETTA: I do. And I think by the way it's something that any of us in Dan Rather's shoes would do the same thing. We would say, I want to be able to look my grandchildren in the eye if I return to Texas as Dan Rather and they say, grandpa, what kind of career did you have? And I want to say I had a noble career. I did these following stories and I had things I'm really proud of. On the other hand, I don't want to be talking to them about a mistake that was made on Sept. 8 when CBS did make a mistake and aired a report where they didn't have full confidence and knowledge of the documents they were airing and then for the next 12 days did not make a full disclosure -- until 12 days later that they made some mistakes. So there were mistakes made, but there are in the span of Dan Rather's career a blip.

TERENCE SMITH: If the report, as some suggest, is in fact critical of Dan Rather himself individually and yet he has months to go in the anchor chair, does that put CBS News in an awkward position?

KEN AULETTA: Well, I think less awkward by the fact that he's announced he's stepping down on March 9. He gets ahead of the report. If he had waited and the report came out and let's say that arguably it was very severely critical of Dan Rather, then I think CBS would be in more of a box than they are today because then what they could say when the report comes out in a couple of weeks, well, we already have an announcement that Dan Rather who has distinguished himself in 24 years in the anchor chair is leaving in March. And we're going to spend this next period of time figuring out who our next anchor is. What they have to hope at CBS is that they don't have to answer more questions than that. They may have to answer questions. Who are the people they're going to lay off or fire because of this report if the report is savage enough?

TERENCE SMITH: Dan Rather has long been a polarizing figure and especially the target of conservative critics and I wonder how you see him in that context this day?

KEN AULETTA: Well, you know, it's interesting, terry. One of the things an anchor really wears several different hats. One hat they wear is as the genial host. They are entering your living room every night. They're offering you a menu of the choices of news for that day that they are presenting and usually doing it in a very even-handed fashion. The other hat they sometimes wear is as an aggressive reporter. Now Dan Rather wearing the aggressive reporter hat tended to engage in less foreplay than, say, Tom Brokaw or Peter Jennings did, tended to be more of a punch you in the nose kind of an anchor. I think it sometimes jarred people. They couldn't get over what happened to the genial host who suddenly became this punch them in the nose reporter? And I think Rather has done that. Now in his view of himself, he's proud of that. He's proud of the fact that he's been a tough reporter. They're all tough and good reporters, these anchors. They have a terribly difficult job to do. But Dan Rather, if you look at the poll measurements hat networks do-- and they all claim not to, but they do, do them-- there are two essential measurements for an anchor. One is what is his or her authority rating? Do people think of that person as authoritative? The second is what is their likeability? Now it happens that anchors tend to have a very high authority rating. Rather does and Brokaw and Jennings do. But the likeability rating, Dan Rather's is lower than the other two anchors. That accounts in part for his lower ratings.

TERENCE SMITH: All right. With Dan Rather and Tom Brokaw stepping down next week you have two of these three very long-serving network anchors. Is this the beginning of the end of an era of the sort of mega anchor?

KEN AULETTA: Well, you know, I'm sure people, if you go back 24 years when Walter Cronkite was stepping down, if you go back to the early '80s when John Chancellor was stepping down and Brokaw was about to step in for him, if you go back to Charles Kuralt stepping down from Sunday Morning or leaving it suddenly actually, people all said the same thing. Can we ever have an icon like Cronkite, chancellor, Huntley Brinkley, et cetera? And the wind-up is that we do. I mean, we have Rather and we have Brokaw and we have Jennings. So will the Brian Williams and whoever succeeds Dan Rather, will they have the same iconic stature that Rather and Brokaw have? We don't know the answer to that now, but based on history you'd have to say they will. What works against them historically is that when Brokaw and Rather took over and Jennings took over, the network news ratings were much higher than they are today. As that news rating and network ratings in general slip, will they have the same kind of reach? Obviously they won't. Will that affect their iconic status? Unclear.

TERENCE SMITH: Well, when you analyze that diminished audience, what is the impact today of these evenings news broadcasts taken either singly or together?

KEN AULETTA: Well, Terry, 27 million people every night, roughly, are watching the three evening newscasts. That's an awful lot of people. If you walk through an airport with any one of the anchors, I dare say that they are better known than, say, Tom Cruise is. You think that's probably not true but it actually is because every day seven to eight or so million people are watching Dan Rather every night. And they're watching him talk about things that are familiar to them, that they care about. It's in their living room not in some foreign movie theater so if you walk down the street where Rather or an airport with Brokaw, people call out. They not only say hello to them. They'll call out and say, hey, Dan, what about Afghanistan? There's a familiarity there. It's really amazing. It's actually one of the reasons why anchors sometimes get in trouble because they're always being watched. They always feel like, my, God, who is going to protect me? So, yes you get the reservations in a restaurant but boy you take a lot of pressure with you as you're an icon because you're really famous.

TERENCE SMITH: What do you think will be the change from the news consumer's point of view? Is it just a change of faces or is it more than that? Is it a change of format or approach or a different presentation of the news?

KEN AULETTA: Well, I think one of the things we have to look at here is because they are iconic figures and they are large figures, when Brokaw leaves next week and Rather leaves in March and Jennings, who is 66 at some point he's going to leave, they have enormous clout within their news divisions. They have the ability at times to withstand... to stand up to the people who sign their checks and say, I don't want to do this, or to get it in their mind and where the people who sign their checks say, hey, I'm not sure we should do this because Dan may object or Dan may not want to do this. Will the Brian Williams's, will the people who succeed Rather and eventually Jennings have that kind of clout where their bosses have to be concerned what does the anchor think? We don't know the answer to that, but that's a concern for the public.

TERENCE SMITH: Of course the network news divisions over which they preside and will preside are much diminished from what they were 24 years ago when Dan Rather sat down in the chair.

KEN AULETTA: When Dan Rather sat down in the chair, first of all if you look at the evening news, there was more international news. They had more bureaus overseas, all three networks did. But in addition to that all three networks did serious document airs then. You don't see those serious documentaries very often on the networks today so it's a very different place, the networks, in part because they're not monopolies. As they lose audience and gain competition from Fox and CNN and PBS and a lot of other places, inevitably they figure out or they try and figure out, how do we get back some of our audience? And inevitably what they do is they begin to show a little more skin or a little more leg which means a little more lifestyle, a little more infotainment and therefore to potentially diminish the brand that made them CBS, NBC or ABC News.

TERENCE SMITH: Ken Auletta of the New Yorker, thanks very much.

KEN AULETTA: My pleasure.

FOCUS - ABSTINENCE EDUCATION

JIM LEHRER: Finally tonight, the debate over abstinence-only sex education. Our report is from Fred de Sam Lazaro of Twin Cities Public Television.

FRED DE SAM LAZARO: Reporter: In the Staples Motley Middle School in rural Minnesota, sex education classes are often led by high school students, instead of teacher Bruce Onischuk. They'll called PSI leaders, or postponed sexual involvement. The program is called ENABL.

SPOKESMAN: Does anybody know what enable stands for? Yeah.

STUDENT: Education Now And Babies Later."

SPOKESMAN: Yes, that's exactly right. Education Now And Babies Later.

FRED DE SAM LAZARO: ENABL has an abstinence-only curriculum. It's one that's been tried here and in a few other Minnesota districts for about five years. The abstinence-only approach is being strongly promoted by the Bush administration.

STUDENT: It's better for teens to wait to have sex. Often people really don't want to have a sexual relationship, but feel pressured.

FRED DE SAM LAZARO: Over several weeks these 13- and 14-year-olds will discuss situations where they are pressured to have sex.

STUDENT: You see a lot of stuff on TV and then their parents.

STUDENT: That's a huge one. Yeah, media influence.

FRED DE SAM LAZARO: Reporter: The reasons to say, "no."

STUDENT: How about pregnancy? How about STDS?

STUDENT: Yeah.

BRUCE ONISCHUK: Who knows what a myth is?

FRED DE SAM LAZARO: And myths are about the only context in which there's any mention of contraception.

BRUCE ONISCHUK: Another myth might be that some of the contraceptions that are out there, condoms, aren't 100 percent foolproof. And they are not. The only thing that's 100 percent foolproof regarding pregnancy and STDS is abstinence.

SPOKESPERSON: You all know what abstinence is, right? Abstinence is not having sex.

FRED DE SAM LAZARO: The student leaders have pledged to remain abstinent until marriage, and a random group of eighth graders we talked to seemed ready to sign on.

KATIE AMUNDSON: Just so you can have a good relationship like with your husband. You don't have that awkwardness of like not being a virgin when you get married.

FRED DE SAM LAZARO:: Is this a goal that you think is realistic for kids at your age?

JOSE ALBA: Yeah. It should be. Because I'm not going to do it until I'm married, I know that.

FRED DE SAM LAZARO:: But surveys show half of American high schoolers and about one-quarter of junior high students are sexually active. And a recent report card on Minnesota's ENABL program found it didn't seem to change those trends. The evaluation was done in three junior high schools that used the program. It found that over the course

of a year, the number of kids who became, or said they intended to become, sexually active about doubled-- a pattern quite similar to the general adolescent population. Critics of the enable program come from left and right of the political spectrum. Nancy Nelson heads a group that advocated a more comprehensive sex education, one which also teaches about contraceptives and how to use them.

NANCY NELSON, MN Org. on Adolescent Pregnancy, Prevention and Planning: We've now spent $5 million of state and federal funds, and these kids don't have the information they need to protect themselves whenever they become sexually active, even if they wait until they're married.

FRED DE SAM LAZARO: Nelson says a particular concern is that the ENABL program was found ineffective in some communities of color, where teen pregnancy rates remain high. She says information about contraceptives is critical for all adolescents.

NANCY NELSON: There was a recent study that showed that in this group of kids who had pledged virginity, 60 percent of them broke their pledges and didn't use protection. That's a big concern. These kids aren't ready, and they're not protected. And we're setting them up for potentially fatal diseases.

FRED DE SAM LAZARO: But proponents of abstinence-only sex education say condoms provide a false sense of protection.

TIM PRICHARD, Minnesota Family Council: We're saying you can have safe sex, when in fact there's no such thing a safe sex. It reduces the risk of getting AIDS by 85 percent. But that's still a one in seven chance that you're still going to contract a deadly disease. I don't think those are very good odds.

FRED DE SAM LAZARO: Tom Prichard, with the group called the Minnesota Family Council, says contraceptives undermine a strong message to abstain from any sexually arousing behavior. He says one reason for ENABL's poor showing is that it dilutes the abstinence message with discussions about just such behaviors.

TIM PRICHARD: Here's a sheet that says "showing feelings in physical ways." This is from the ENABL program. And they list a number of categories: "Given friendly looks and smiles," "holding hands," "put arms around, hold close and kiss, "explore above the waist, explore below the waist," and "have sex."

FRED DE SAM LAZARO: That handout, in your mind, is clearly a slippery slope.

TIM PRICHARD: Oh, I think it clearly is. It's encouraging sexual exploration. And once you start down that slope, it's hard for kids to stop.

FRED DE SAM LAZARO: Staples Motley teacher Bruce Onischuk says the handout is part of learning to set limits.

BRUCE ONISCHUK: In some of our discussions in class, I've talked to the kids that if you reach a certain point in your physical contact, whether it's hand holding, kissing, petting, heavy petting and, you know, the list goes on, there comes a point in time where it's really tough, or it's very difficult to all of a sudden say, "whoa, no, we're stopping, and we shouldn't go any further than that."

FRED DE SAM LAZARO: Do you kids are able to stop, have the tools to be able, you know, to know where their limits are?

BRUCE ONISCHUK: Part of what we... part of what's discussed in ENABL are refusal skills in how to handle situations.

FRED DE SAM LAZARO:: At the heart of this debate and teachers' dilemma is how adolescents handle information. For example, does teaching about how to use condoms lead to more sexual activity?

BRUCE ONISCHUK: I believe there will be more activity, I really do. I think it's human nature. But then again, I see the other side of the argument, too: If these kids are sexually active, shouldn't we provide some protection for them?

FRED DE SAM LAZARO: The Staples Motley District does offer a so-called "Values and Choices" course.

STUDENT IN SKIT: Hey, come on. Everyone else is doing it.

STUDENT IN SKIT: Maybe. I'm not everyone else.

FRED DE SAM LAZARO: The curriculum does press abstinence, but also provides basic information on how to use contraceptives. District Superintendent Kenneth Scarborough says he'd prefer to stick with abstinence, but wants to be realistic.

KENNETH SCARBOROUGH, Superintendent: We hope, and we present tools for them to discuss these issues with their parents. But we have to be real about the choices that our students are making, and we have to give them information to be safe.

FRED DE SAM LAZARO: One thing the schools do not offer are contraceptives in the nurse's office. It's prohibited at schools receiving certain federal grants. But it's not difficult to get condoms here. And that's common knowledge to eighth graders.

STUDENT: Gas stations.

STUDENT: Bathrooms.

FRED DE SAM LAZARO: Amid the heated debate and conflicting research on what works with sex-ed, parents we talked to said they were satisfied with the approach taken in Staples Motley. Despite poor marks so far, Mary Freeman says the abstinence-only method seems right in middle school.

MARY FREEMAN: I think that this target audience of twelve to fourteen, they don't need that information yet. They need to hear that abstinence-only information. And I think if you start from there and then you give them more information later, then they have choices, then they have decisions to make. And usually what kids bite on first is what they'll chew on the longest. And I think if you give them this abstinence-only message, I think it will stick.

FRED DE SAM LAZARO: Meanwhile, Minnesota state health officials say they're not ready to dismiss the ENABL program. They say a couple more years of research is needed to assess whether its message does stick. One trend no one questions is the growth of the abstinence- only approach. It's now the only sex education curriculum offered in about one- third of all U.S. public schools.

RECAP

JIM LEHRER: Again, the major developments of this day: The U.S. Military launched a new offensive south of Baghdad, aimed at rooting out insurgents. Some 200,000 protesters rallied in Ukraine's capital for a second day. They claimed last weekend's presidential runoff was rigged. And Dan Rather announced he's stepping down as anchor of the CBS Evening News. We'll see you online, and again here tomorrow evening. I'm Jim Lehrer, thank you and good night.