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CNN Newsnight Aaron Brown

Pfizer Pulls Celebrex Advertising; Bush Holds Press Conference

Aired December 20, 2004 - 22:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


AARON BROWN, HOST: Good evening, again, everyone. Pfizer, the drug company giant said today it was pulling all its consumer-directed ads for the pain reliever, Celebrex, in the wake of the study showing that in high doses, in high doses, it may cause an increased risk of heart attack or heart disease. First it was Vioxx. Then it was Bextra and now it is Celebrex. What Pfizer is not doing is pulling the drug completely off the shelves. It maintains it is normal or at least it works fine in normal doses, that it's perfectly safe when it's used as directed.
As you'll hear as we go along tonight, not everyone agrees with that. Pfizer's chairman, however, when we talked to him, said every study ever done, over a period of 10 years, has shown that at least where Celebrex is concerned, the drug is safe. You'll hear from him. You'll hear from the critics. But first, we need to do some background on the kind of drug that we're talking about and the tests done on it. So we begin with CNN's Elizabeth Cohen.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN CORRESPONDENT: We're all hearing just now that the drug Celebrex might cause heart problems. But Dr. Garrett Fitzgerald first noticed something might be wrong five years ago. That's when he saw something disturbing in his lab at the University of Pennsylvania, first in mice and then in humans. He noticed that Celebrex eased pain by blocking production of a certain type of fat, but that same kind of fat helped protect the heart.

DR. GARRETT FITZGERALD, UNIVERSITY OF PENNSYLVANIA: When you shut down this fat to alleviate pain and inflammation, you're exposing the cardiovascular system to hazard. So it's really a double-edged sword.

COHEN: Dr. Fitzgerald published his research and spoke about it at international conferences but he says the drug companies that make Celebrex and similar drugs called Cox 2 inhibitors, didn't pay much attention.

FITZGERALD: We thought this was something well worth pursuing. The companies involved at the time were somewhat dismissive.

COHEN: Pfizer, which makes Celebrex, says they did take Dr. Fitzgerald's study seriously and that many subsequent studies by other scientists showed there were no cardiovascular problems with Celebrex.

DR. GAIL CAWKWELL, PFIZER: We weighed the evidence and we found evidence both in people and in studies in animals that contradicted some of Dr. Fitzgerald's work.

COHEN: Dr. Fitzgerald says the experience with these pain relievers is a lesson in how a blockbuster class of drugs, heralded by some as wonder drugs, could come tumbling down. Vioxx was the first of the Cox two inhibitors to have trouble. It was taken off the market in September, after studies showed it could cause heart problems. Then last week, the "New England Journal of Medicine" published a letter from a group of researchers saying doctors should stop prescribing another Cox two called Bextra, again because of cardiovascular concerns. Days later, the National Institutes of Health released the news that people taking Celebrex were 2 1/2-times more likely to suffer a heart attack or stroke.

FITZGERALD: The entire experience with Cox two inhibitors is an example of blockbuster overreach.

COHEN: The three Cox two inhibitors earned $5.3 billion in sales last year, more than all over-the-counter pain relievers combined. Some say that's because Celebrex, Bextra and Vioxx were some of the most highly-marketed drugs ever.

(END VIDEOTAPE)

COHEN: Well, that was the middle of our Celebrex story. The moral of the story, what people say with these Cox two inhibitors, is that some researchers like Dr. Fitzgerald say that there was evidence relatively early on, when the drugs were first being marketed, that they could cause cardiovascular problems. And then, last week, a study from the National Cancer Institute that said, even at regular doses, even at doses that are recommended by Pfizer, that they can increase the risk of heart attacks and strokes by 2 1/2 times. And that, some people are saying raises quite a bit of concern. That's why, at the request of the Food and Drug Administration, Pfizer has pulled ads, ads like some of the ones you just saw in our story, have pulled those ads off the air and out of newspapers and magazines. However, the drug is still on the market. Aaron?

BROWN: OK. I've got one question on Celebrex. I need you to turn you to something else. OK? Viewers will hear this in a moment. But the CEO of Pfizer says that in all of the studies -- studies involving 40,000 patients, not only has Celebrex not shown itself to cause cardiovascular problems, but in fact, the reverse is true. So how does that square with what you're hearing, generally, about the problems of these Cox 2 inhibitors?

COHEN: The bottom line is that there have been so many studies on these drugs that some of this are contradictory. That's really the only thing that can be said right now. For example, last week, we all heard about this National Cancer Institute study that showed that regular doses that could increase cardiovascular risk 2 1/2 times. However, at the same time, Pfizer did a study that said that it didn't increase cardiovascular risk at all. They also didn't say that it protected the heart or that it protected you from stokes. They just said that it didn't seem to have any effect on heart health at all. So certainly if they're referring to a study that shows that Celebrex protects at all, that certainly wasn't the one. So what you have here is you have studies that contradict each other and Aaron, I'm going to look into my crystal ball, the one that you're about to ask me about is even more contradictory. So go ahead and we can talk about that other issue.

BROWN: I hate when you do that. Now, it's an over-the-counter drug which is the generic form of Aleve, I guess.

COHEN: Right. Aleve is an over-the-counter drug and the chemical in that is called naproxen. Naproxen is sold both as prescription and over-the-counter as Aleve and as other drugs. Now what happened today was that the Food and Drug Administration had a conference call with reporters and they said look, the National Institutes of Health has just done this study where some people were taking Celebrex. Some people were taking naproxen, which is Aleve. And the folks who were taking naproxen, they had a 50 percent increased risk of heart attacks and stroke, a 50 percent increased risk of heart attacks and strokes, when taking Aleve which, again, the chemical in that is naproxen.

Now interestingly enough, the folks who were taking Celebrex, they did not have any increased risk of heart attack or stroke. They just saw the problems in that study with naproxen. Now this of course has everyone scratching their heads. How could that be? The bottom line is that the FDA is now telling consumers if you're going to take naproxen, take it only for 10 days. Limit it to that. If you need pain relief beyond that, go talk to your doctor.

BROWN: Yeah. Elizabeth, thank you very much, Elizabeth Cohen down in Atlanta tonight.

One of the many questions raised by all of this, how did the link between all of these types of drugs, these Cox 2 inhibitors and heart attacks go unnoticed for so long? Why wasn't the risk detected before the drugs were approved? The answer may lie, in part, in how drugs get approved.

(BEGIN VIDEOTAPE)

BROWN (voice-over): For a drug company to win FDA approval for a new drug, it must first outline the studies it plans to conduct to test how safe and effective the drug will be.

ALAN GOLDHAMMER, Ph.D, ASSOC VP REGULATORY AFFAIRS, PHARMA: They have to register those clinical trials with FDA and FDA must give their assent before the clinical trials are started.

BROWN: This is a crucial step, according to Dr. Jerry Avorn, a professor at Harvard Medical School and author of "Powerful Medicines."

DR. JERRY AVORN, AUTHOR, "POWERFUL MEDICINES": The way we learn about drug side effects has everything to do with the way the companies set up the studies before they bring the results to the FDA. And of course it's the companies that do the studies of these drugs, not the FDA or other groups. BROWN: Dr. Avorn says how drug studies are designed may actually prevent problems from being detected. To begin with, he says, the study must last long enough.

AVORN: If you've got a side effect that isn't seen until after six months of using a drug, at all of the pre-approval studies only lasted for two or three months, you could easily miss that.

BROWN: Another crucial factor -- who participates in the study. Are the people enrolled in a clinical trial similar to those who will actually take the medication once it's approved and marketed? A study must also be large enough to uncover dangers. Say for every 5,000 people that take a drug, only one will develop the side effect.

AVORN: You're going to miss that if you're study only included 3,000 people and the side effect occurs only once in every 5,000.

BROWN: Once in every 5,000 may not seem like a lot. But when a drug is used by tens of millions of people, as Celebrex or Vioxx or Bextra have been, it's a much different picture, with potentially thousands of people at risk of being harmed.

(END VIDEOTAPE)

BROWN: Now, to the business side. Celebrex was one of the most heavily-marketed drugs in history. At least 26 million Americans have used it. It makes Pfizer a ton of money and its chairman is defending it at every turn. We talked with Pfizer CEO Henry McKinnell, late this afternoon.

(BEGIN VIDEOTAPE)

BROWN: Sir, you made a decision to stop marketing Celebrex on television directly to consumers. And here's what's curious about that to me. If you argue and you do, that the drug taken at a normal dosage level is still safe, then why stop the marketing of it at the consumer level?

HENRY McKINNELL, CEO, PFIZER: Well, we have a complicated message around safety to deliver here. I know it's confusing a great deal of people and we wanted to focus on communications with doctors and doctors' communications with patients and not have that cluttered by consumer marketing.

BROWN: Does any of this give you pause about this whole area of marketing directly to consumers, whether it's this drug or any other drug that you market to consumers on television and magazines and the rest?

McKINNELL: Well, some concern I must admit. What we're trying to do is convince patients to see doctors. The part of the message that we probably should be emphasizing is it is your doctor who has the full information around side effects and safety and efficacy and is the best person to make a judgment of what medicine is best for you. I think that needs to be emphasized in future direct to consumer advertising. BROWN: I want to move on from this and without beating this to death. What is seems to me in these ads, whether it's yours or others, you want me to go to the doctor and say what's this deal with Celebrex? Or what's this deal with -- fill in the blank. Not simply go see your doctor more often. That's not an unreasonable conclusion to draw, is it?

McKINNELL: I think that's right. And I think the part of the message that needs to be strengthened is that your doctor has full information on the benefits and risks of these products and you should discuss the best option for you with your doctor.

BROWN: Let's move on to the drug itself for a bit. You said the other day, you take it. You argued all weekend long. And I think there's been some supporting physicians who made the same argument, too, that taken at an appropriate consumer level, it's a safe drug. Do you have any concern, though, that as more studies are done, on the long-term use of these Cox two inhibitors, we're going to find that there's simply an unacceptable risk in them, despite the undeniable benefit?

McKINNELL: Well, we need to have confidence in the safety. We cannot compromise on safety. What seems to be missing in the whole discussion is that we have extensive clinical data around both the safety and the effectiveness of Celebrex in controlled clinical studies over 10 years, involving more than 40,000 patients, which show no risk of cardiovascular damage. We also have five published studies. And five out of the five of very large groups of patients, many in real-world settings from managed care groups, for example. Five out of five studies show no cardiovascular risk due to Celebrex. In fact the Celebrex-treated patients have less cardiovascular events than those patients receiving no treatment at all. We also have three long-term studies, two of which show no cardiovascular risk. This one study is not really consistent with everything else we know about this drug.

The one study being the one that caused you -- that has caused this whole uproar over the last three or four days. Do you think, by the way, just as an aside, that the uproar would be the same were it not for both Vioxx and Bextra coming under question?

McKINNELL: I think it would because so many people benefit from Celebrex, some 27 million Americans. Obviously, we need to be concerned with safety signals and this is a safety signal. What we're saying is we need to keep this in context with what else we know. And if you have questions about the use of Celebrex, your doctor's the best person to talk to.

BROWN: We know that going back years with Vioxx, there were -- I'm using this as a layperson, OK? There were some red flags. There were studies that showed heart incidents which Merck then said that really had more to do with the sort of non-aspirin effect, if you will, in the study. Have there been any studies in Celebrex that caused you to wonder, if there might be an increased chance of either heart disease, heart attack or stroke? McKINNELL: Well, actually just the opposite. The latest of these large studies was done by Dr. David Graham, the FDA whistle- blower. He looked at 1.4 million treatments in the Kaiser database. And he found at the highest dose of Vioxx, a three times risk, versus patients who received no treatment at all. Celebrex, on the other hand, had lower risks than any of the treatment options. And even had a lower risk, 0.86, than those patients in the study that received no treatment at all.

BROWN: Just a final question before we lose you, sir. And back to the beginning. Is it possible that the money, in its considerable millions that companies like yours and other drug companies spend on marketing, consumer marketing might be better spent on R&D?

McKINNELL: We spend more money on R&D than we do on marketing. But remember, we don't actually sell our products. All of the resources we put into quote, sales and marketing is really to make sure that physicians and patients are fully aware of all the information around the risks and benefits of the medicines we are offering. And then we leave it to the doctor and the patient to decide what is the best option for them.

BROWN: Sir, it's good to see you. It's I imagine a difficult few days. But you've been out there and I think those of us who do what I do for a living, appreciate that you've been out there. Thank you.

McKINNELL: Thank you, Aaron.

(END VIDEOTAPE)

BROWN: Thank you, CEO of Pfizer. In a moment, we'll consult with two doctors, Dr. Sidney Wolfe, Public Citizen, Dr. John Abramson, the author of "Overdosed America," who may see some of this a bit differently.

Later, we'll bring you up to date on one of the other stories that have people talking the last few days, a woman accused strangling a mother-to-be, then making off with her child.

Also the president's change of tone on Iraq after an especially rough weekend in the war. We'll take a break first from New York. This is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: More now on Celebrex and Bextra and the rest. A moment ago, you heard Henry McKinnell, the CEO of Pfizer. Here's a bit of what he had to say, it bears hearing again, about how drugs are sold or not, as the case may be.

(BEGIN VIDEO CLIP)

McKINNELL: Remember, we don't actually sell our products. All of the resources we put into quote sales and marketing is really to make sure that physicians and patients are fully aware of the -- all the information around the risks and benefits of the medicines we are offering. And then, we leave it to the doctor and the patient to decide what is the best option for them.

(END VIDEO CLIP)

BROWN: To the stockholder, the idea that the drug companies don't in fact sell drugs might seem odd. It wouldn't be the only oddity. The system is a strange cocktail of public and private. Some of the R&D Mr. McKinnell spoke about is done on the taxpayers' dime. Regulators leave the government and work for drug companies and vice versa. Doctors hand out samples like candy and people are supposed to ask their doctors, without asking their doctors, about any specific drug, certainly not the one we see in the commercial.

Where's a good doctor when we need one? We're joined by two. Dr. Sidney Wolfe of Public Citizen's Health Research Group and in Boston, Dr. John Abramson, the author of "Overdosed America" and it's good to have you both with us. Dr. Wolfe, just one quickie on Celebrex before we move on. Should it be on the market today?

DR. SIDNEY WOLFE, PUBLIC CITIZEN HEALTH RESEARCH GROUP: It shouldn't be and Pfizer's wishful thinking that by banning the direct to consumer advertising they can convince the FDA to keep it on the market is just wishful thinking. This drug is too dangerous to be on the market. Mr. Mckinnell is at the very least misleading, at the worst lying, when he tells people that the company doesn't sell drugs. Right after Vioxx came off the market, the company ran full-page ads in "The New York Times" and many other newspapers saying Vioxx is bad. Our drug is perfect good. Four years ago, an FDA physician looked at a very well-controlled, large study on Celebrex and said he was worried about the increased blood clots that were occurring with the drug.

BROWN: I'm sorry, let me get Dr. Abramson in here for a second. It is a bit -- I'm hesitant to say any guest on this program is disingenuous. But it was a bit disingenuous I thought to say as Mr. McKinnell said, that they're not out there selling drugs. My goodness, you have ads for drugs where they don't even tell you what they're for. They're just trying to implant the name.

DR. JOHN ABRAMSON, HARVARD MEDICAL SCHOOL: Aaron, you're absolutely right. Not only are they selling drugs to consumers by having these ads that make people look like they're enjoying activities that they couldn't enjoy otherwise, when we all know that Celebrex provides no better relief from arthritis pain. But the most important thing here is how the doctors have been misled. I think Mr. McKinnell is being a little bit dis -- well, he may be exaggerating a little bit when he says that Pfizer doesn't sell drugs. The report of the class study, which was the big study, 8,000 people with osteoarthritis, comparing Celebrex to older anti-inflammatory drugs. The results were reported in "The Journal of the American Medical Association." That report said Celebrex when taken for six months, causes fewer GI complications than the other drugs.

But the truth is, it wasn't a six-month study. It was a 12-month study. And the FDA had definitively rejected the company's argument to present just six months of the study. The full 12 months of the study shows that Celebrex provides no greater GI benefit than the older, far less expensive drugs. So now, we've got a cloud of cardiovascular risk hanging over this drug. What are the benefits? It's no safer. It's no more effective and it's far more expensive. So it's hard to see why fully-informed doctors and fully-informed patients would be buying $3 billion worth of this drug a year.

WOLFE: I agree...

BROWN: If I could insert one thing for people that haven't followed it this closely. One of the arguments in favor of these drugs as opposed to aspirin or ibuprofen or whatever is they cause less stomach problems, gastrointestinal problems. I hate to sound like the doctor. Now, Dr. Wolfe, you were about to say?

WOLFE: Well, as Dr. Abramson said, we knew four years ago that this idea that Celebrex protected the stomach was false. So we now have a drug that has unique risks. It causes an increase in heart attacks. It has no unique benefit either in terms of effectiveness or in terms of GI and it's still on the market.

We have a Web site called worstpills.org where we list 181 drugs that we think are too dangerous to use and safer alternatives. They include Vioxx, off the market now, Celebrex and Bextra, hopefully soon to come off the market and Crestor, a cholesterol drug. The problem is that neither the company, Pfizer or Merck or any of the other ones, nor the FDA are really doing an adequate job, warning or informing either patients or doctors. The FDA has pretty much stopped enforcing the laws and regulations on misleading advertising. Pfizer was caught just a few weeks ago making outrageous misleading claims on Viagra, their drug for impotence. So this is an industry that is desperate, that is doing everything possible to mislead patients and doctors and then saying we don't sell drugs.

BROWN: Dr. Abramson, just on this question of pain relief -- should I just take two ibuprofen and not worry so much about it? I mean is there anything out there that is truly, significantly more effective than what I can go to the drugstore and buy?

ABRAMSON: No. There isn't Aaron. In fact, the new drug application for Celebrex -- Celebrex was tested against two Advil tablets, exactly what you're saying, for dental pain. And two Advil tablets provided significantly better relief than all doses of Celebrex that were tried. So actually you're two Advil tablets are superior in terms of providing pain relief.

BROWN:Is the industry so big and so powerful at this point that it can -- get away with it sounds a little more nefarious than I mean. But that can get away with it? Is that right?

WOLFE: I think that's true. In Washington, there are more drug industry lobbyists in Washington over 600, than there are members in Congress. They push the Congress away with lobbyists, with campaign contributions and so forth. And the FDA, which is technically part of the Public Health Service, is getting hundreds of millions of dollars in cash directly from the industry, to help them regulate drugs. What it does help them do is be kinder to the industry. Kindness on the part of the FDA to the drug industry, translates into increased risk to patients though.

BROWN: Let me give, Dr. Abramson the last word. We were chatting just before we went on the air. This -- a lot of things that happened in a short period of time with Vioxx, Bextra and Celebrex. Are we at one of those moments, where policy may, in fact, be changed or will it do you think just pass?

ABRAMSON: No, I think we're there, Aaron. I didn't think we were going to get there when it was just Vioxx. But I think now with Celebrex, people are starting to get the idea that the real crisis in American medicine is that even the most disciplined, dedicated doctors, can no longer get accurate information. Because the drug companies have so much influence over what we believe the best medical care is. I think the American public is now getting the picture. And this problem is fundamentally not a scientific problem. It's a political problem.

BROWN: Gentlemen, good to have you with us. We appreciate your time. Have good holidays. Thank you.

A couple more items before we head to break or medical school as the case may be. It sort of feels like that tonight. The first promise is to simplify life for AIDS patients who now take four anti- viral drugs a day or more. Today two competing drug companies said they'll pool their resources to create a single pill that does the work of three.

Also today, the Food and Drug Administration approved a rheumatoid arthritis drug Remicade for treating a crippling spinal disease, alchalozians fondalitis (ph). This is in fact in the medical sense, changes very little. Doctors had been prescribing it off- label, as it's called. But FDA approval means it is now more likely that insurance companies will pick up the tab, which can run $1,000 or more per month.

Just ahead -- the proofs of the latest arson investigation, in the history of the state of Maryland.

And a president goes on the offense to protect the man in charge of the defense, if you will. We take a break first from New York. This is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: November was a bad month. We're a month behind, still.

No Americans lost their lives in Iraq today. That's good news. Two Americans, however, died in Kuwait City, a traffic accident over the weekend. But there have been no American combat fatalities in Iraq since last Thursday, good news, but by no means the only news. Another car bomb went off this afternoon in Karbala, wounding several, but killing none, unlike the two bombings yesterday, one in Najaf, one in Karbala, which killed at least 66 people, police today rounding up dozens of suspects, Iraq's prime minister calling the attacks a deliberate attempt to widen the divide between Iraq's Sunni and Shiite communities.

And, in Washington, the president acknowledged as much and more. The bombers, he said, are having an effect on the upcoming election preparations, but also on the larger mission. The president said what he said in his second press conference in six weeks, which, frankly, is a lot for him. It took place with public doubts about the war growing and confidence in his defense secretary slipping.

It was also to many ears somewhat of a departure in tone and content from what the president had been saying about Iraq during the campaign.

So, from the White House tonight, CNN's Dana Bash.

(BEGIN VIDEOTAPE)

DANA BASH, CNN WHITE HOUSE CORRESPONDENT (voice-over): The president was strikingly candid about a problem in Iraq. The effort to build up its army so American troops can start coming home is not going to plan.

GEORGE W. BUSH, PRESIDENT OF THE UNITED STATES: I would call the results mixed, in terms of standing up Iraqi units who are willing to fight. There have been some cases where, when the heat got on, they left the battlefield. That's unacceptable.

BASH: One goal of the end-of-the-year news conference was to talk up Iraq's progress. But he also conceded this about a spike in suicide bombings.

BUSH: No question about it. The bombers are having an effect.

BASH: Mr. Bush stood firmly by his embattled defense secretary, whom critics call responsible for Iraq policy failures. Rumsfeld's been most recently under fire for ignoring pleas for more armored vehicles in Iraq, and using an auto-pen, not his own hand, to sign letters for families of troops killed there.

BUSH: I have seen the anguish in his, or heard the anguish in his voice and seen his eyes when we talk about the danger in Iraq. You know, sometimes, perhaps, his demeanor is rough and gruff, but beneath that rough and gruff, no-nonsense demeanor is a good human being.

BASH: The president expressed disappointment but no regret for the ill-fated choice of Bernard Kerik for homeland security secretary, offering a veiled nod to critics of the White House vetting process.

BUSH: The lessons learned is continue to vet. And ask good questions.

BASH: Controversy over Kerik and Rumsfeld may already have dimmed the president's postelection glow. A new CNN/"USA Today"/Gallup poll shows his approval rating back below 49 percent, down 6 points in just a month. Bush aides understand building up his standing is crucial to pushing second-term goals, like reforming Social Security. There, the president deflected questions on specifics, beyond wanting private accounts for younger workers.

BUSH: I'll propose a solution at the appropriate time, but the law will be written in the halls of Congress.

BASH: Dana Bash, CNN, the White House.

(END VIDEOTAPE)

BROWN: Another batch of government documents obtained by the ACLU is causing a stir tonight, among them, an e-mail sent from an FBI agent in Iraq to senior bureau officials back home. In it, the agent repeatedly refers to an executive order authorizing certain harsh methods of interrogation. The methods include sleep deprivation, the use of hoods and dogs. The White House today said no such order exists. There were denials, too, from the FBI, the Justice Department and the Pentagon.

Intuition tells you that, in a bad economy and in a time of peace, military recruiting is a whole lot easier than it is in an improving economy and a time of war. Intuition in this case would be right. And compounded by the fact that so many people who might join the Reserves these days are stay in the Reserves are not, because they've either been to Iraq and had enough or want to avoid the war in the first place. So, is there a crisis in the reserves? Depends on who you ask.

(BEGIN VIDEOTAPE)

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: I'm the guardian of freedom.

UNIDENTIFIED FEMALE: And the American way of life.

(END VIDEO CLIP)

BROWN (voice-over): The ads no longer sell the National Guard as one weekend a month and two weeks in the summer, not when the part- time soldiers of the Guard and Reserve, make up some 40 percent of the troops toughing it out these days in Iraq.

The National Guard announced last week that it was sending out more recruiters and dramatically increasing enlistment bonuses, especially for those with military experience. And today, the Army Reserves did the same. They both missed their recruiting goals the past two months, the Guard by almost a third. And the commander of the National Guard admits these days it is a tough sell.

LT. GEN. STEVEN BLUM, NATIONAL GUARD CHIEF: The economy is recovering. We're a nation at war. Service in the National Guard means not if you're going to stay in your fair rotation overseas or here at home, but when that rotation will occur. BROWN: A major problem is that many seasoned troops, leaving the regular Army, are no longer entering the Reserves, seeing them as just a return ticket to Iraq. Outside observers, including a former defense secretary in charge of man power, bluntly now, are predicting a crisis.

LAWRENCE KORB, SENIOR FELLOW, CENTER FOR AMERICAN PROGRESS: Because your next troop rotation is scheduled this spring, if you still need 150,000 troop there, you're going to have to call up more Reserves. You're also going to have to send a lot of active duty people back who haven't had very much time at home. And when those people come back, then they're simply not going to stay.

BROWN: Korb says that, where new technology in the Air Force and the Navy is allowing those branches to actually cut their numbers and it's too early to tell the effect of the occupation on the Marines, the effect of longer and more frequent deployments on the Army is clear and a concern.

KORB: You will begin to break the force in the sense you'll lose you're senior noncommissioned officers, your warrant officers, your middle-grade officers, your captains and majors.

BLUM: We're finding that this war is actually stretching the National Guard. And we're getting to be a more capable, more effective and more competent force.

BROWN: The regular Army announced new recruiting incentives back in August and says it is now meeting its goals. Critics say that is only possible with lowered standards and early inductions and that the real problem is, the military is simply too small for its new responsibilities.

JOHN ALLEN WILLIAMS, LOYOLA UNIVERSITY CHICAGO: We have a military that's good enough to take down a regime, but not large enough to do the kind of peacekeeping tasks and the reconstruction tasks that are necessary to actually win the war.

BROWN: All agree it is not an issue of patriotism. Americans continue to sign up and serve. But under the relentless pressure of Iraq, it may turn out to be a case of simple exhaustion.

(END VIDEOTAPE)

BROWN: Still to come on the program tonight, if you think your morning commute is bad, be thankful you don't have to drive through Volusia County, Florida. You will get the picture.

And if you don't have time to read the papers before taking off to work in the morning, why, we'll do that for you, more or less.

We'll take a break first. Around the world, this is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: Police in Maryland now have a fifth man in custody in connection with a string of house fires that did about $10 million damage to a subdivision just outside the nation's capital. Sources say this fifth suspect is an acquaintance of the other four, one of whom was a security Guard for the complex. As for motive, lots of speculation, but nothing solid.

Kansas next. The woman accused of strangling a pregnant woman and cutting the fetus from her womb made an appearance in federal court. The judge is reading the charges against Lisa Montgomery, kidnapping and murder, capital offenses. Ms. Montgomery kept her eyes downward the entire time, said nothing. Her husband spoke with local news crews outside the courthouse.

(BEGIN VIDEO CLIP)

KEVIN MONTGOMERY, HUSBAND OF LISA MONTGOMERY: My heart ain't broke just for me and Lisa and her kids. It's them, too. That was a precious baby. I know.

(END VIDEO CLIP)

BROWN: Pretty heartbreaking story. Ms. Montgomery's next court appearance is scheduled for Thursday.

Got a little behind tonight. Need to take a break. Ahead on the program, what a doll. Or, is it, what? A doll?

(BEGIN VIDEO CLIP)

DAVID HORVATH, CREATOR, UGLY DOLLS: I would love to be called ugly, because, to me, ugly means OK with being yourself and being different.

(END VIDEO CLIP)

(COMMERCIAL BREAK)

BROWN: News, we say, is supposed to be a search for truth, and art, the pursuit of truth and beauty. So, where does that leave business? Well, sex does sell. And a pretty face never hurts. But for one growing business, ugly is pretty good, too.

(BEGIN VIDEOTAPE)

HORVATH: Hi there. I'm David Horvath. I'm the creator of the Ugly Dolls. And welcome to the Ugly Doll warehouse. Welcome to ugly town.

Ugly Dolls started as a sad story. My girlfriend, Sun-Min, had to go back to Korea right after we graduated. So I would send you these miss-you letters with Wage at the bottom. And, for a Christmas gift, she sent back a plush version of him that she had hand-sewed for me as a gift. I showed that Ugly Doll to a friend of mine who owns a Giant Robot store in Los Angeles.

And he said, oh, these are great. I'll take 20 of them. I want to put them in my shop. So, we made a few more and dropped them off at the store. And they sold out in one day.

Thanks to the Ugly Dolls, actually, we were able to reunite about a year ago. And we plan to marry next year. It's just a play on words, really. There is no ugly, we think. And when they actually feel them and you get them closer to you, they don't seem so ugly at all and they're quite endearing.

Well, it definitely starts as many sketches. I'll whip up 100 different sketches and pass them over to Sun-Min. And she'll kind of take an eyeball from this one and some legs from that one and in some cases, Completely throw away my bad drawings and come up with her own.

There's nine right now, with a newborn on the way. There's Wage. And he's the first Ugly Doll. He's our orange guy with the apron on. Then, there's Babo, who is the baby, loves cookies. There's Tray. Tray is our girl. There's Target, who is the grandpa. There's Cinko, our hydrophobe. Then we've got Jeero, our macho guy. We have got Wedgehead and Ox, our naughty boys. And then there's Ice-Bat, the cold-weather pet. He lives in an ice box. And everything he touches turns to ice.

For me, it's just a lot about storytelling. The toys today, they seem to do everything for you. And everything has these incredible super-robotic features. But we just wanted to create something very simple and honest that leaves a lot to the imagination.

I would love to be called ugly, because, to me, ugly means OK with being yourself and being different. We're all very different, right?

To see the reaction of the kids at PS3, that was just incredible. We love it that adults are so into the Ugly Dolls. But to hear from kids that they really identify with the characters, it sends a really great message out there.

UNIDENTIFIED FEMALE: My Ugly Doll, I'm -- sort of what I'm like.

HORVATH: You can find them anywhere, from Barney's in New York, the Design Museum in London, to little mom-and-pop toy shops all across the country. They are our little children. But we like them to be your little children, too.

Bye-bye, Babo. Have a good time. Have a safe trip.

(END VIDEOTAPE)

BROWN: The work of NEWSNIGHT producer Mary Anne Fox (ph).

Still ahead on the program, a little news, a little weather, a little traffic. Traffic? Yes, traffic.

Break first. We'll be right back.

(COMMERCIAL BREAK)

(ROOSTER CROWING) BROWN: Okeydoke, time to check morning papers from around the country, around the world. There are so many I like today. We'll see how many we get done.

"International Herald Tribune." "Some Iraqi Forces Not Ready, Bush Says. He Warns Against Expecting Quick Exit. Rumsfeld Backed as Good and Decent Man." That is the correct lead, in my humble opinion, the president saying Iraqi forces not ready.

However, "The Washington Times" didn't think so. We often disagree, I think. "Bush Presses For Reform on Border Policy, Says Illegals Fill Unwanted Jobs." That's a big story to that newspaper. And, therefore, they made it their lead. It's their paper. They get to do what they want. "District Close on Stadium Deal. Cropp, Williams Discuss Compromise." I'm sure that the District will cave in to the wishes of Major League Baseball. It's just the way it always works. There goes my job as commissioner.

"Chattanooga Times Free Press." I like this story. "Interrogations in Iraq Beyond FBI Standards." Everybody is denying the president signed this executive order, except some FBI agent says he saw it. There you go. "Anniston Ramps Up 24/7. Workers Weld Armor For Humvees." The "Chattanooga Times Free Press" reporter really started this whole thing on the armor. And they are going to town on it. They are not letting go of this story, which is what you do if you got yourself a story.

"Boston Herald." "Tanker Attack Would Destroy Hub." Well, there's your uplifting pre-Christmas headline for you. And, by the way, you can take their greedy celeb quiz. I will not be a part of that.

"The Philadelphia Inquirer." Uh-oh, it's stuck. How we doing on time? Thank you. "Philadelphia Inquirer." "Bush Critical of Iraqi Forces." As we say, that is the right lead. But their big story, "Oh, the Pain. Owen's Season Likely Over," this Terrell Owens, or T.O., as I call him, hurt his leg. And, actually, they give you a -- this is how big a deal this is in Philadelphia. They give you a diagram of how he and where he hurt himself. Anyway, he's going to have surgery. And there goes that season, or maybe not. You never know. The good ones play hurt. I do.

"San Francisco Examiner." "City Will Seek $500,000 Fine Against PG&E." The paper almost always leads local.

Let me do this one and then we'll do the weather. "Cincinnati Enquirer." "White Christmas a Very Good Bet." I don't know if it snowed where you are, but it snowed where I am today. It snowed in New York. And it was cold.

Speaking of which, the weather tomorrow in Chicago, "ominous." Hmm.

Speaking of which, ominous things in Florida, we'll show them to you when we get back.

(COMMERCIAL BREAK)

BROWN: Bill Hemmer with a look ahead at tomorrow's "AMERICAN MORNING."

(BEGIN VIDEO CLIP)

BILL HEMMER, CNN ANCHOR: Aaron, thanks.

Tomorrow on "AMERICAN MORNING," Howard Stern says it will be the death of FM radio. But is Sirius satellite radio really all that? We'll talk to the man who is banking on it, the CEO, Mel Karmazin, one of the people who made the biggest impact on 2004. Our series is called "They've Got the Goods." And it continues tomorrow. See you at 7:00 a.m. Eastern time on "AMERICAN MORNING" -- Aaron.

(END VIDEO CLIP)

BROWN: Bill, thank you.

We give you Chicago's weather every night, but rarely do we do the traffic report. Tonight, we couldn't resist, showing what a mess it is, or will be at least, tomorrow, in Deltona, Florida. Take a look. A 12-floor sinkhole -- that's probably a 12-foot sinkhole -- that formed Saturday is more now than 225 feet deep.

Man, you got to run into the ocean or something to get that deep. Civil engineers say it could be a week before the hole stops growing. That's what they said about me, too. About 25,000 drivers are going to have to find an alternate route until this gets fixed. There you go, traffic and weather together on NEWSNIGHT.

Just -- you can't resist a good sinkhole story. I don't care how sophisticated you are. It's just something you can't resist.

Good to have you with us. We're all back tomorrow. "LOU DOBBS TONIGHT" next for most of you.

Until then, good night for all of us at NEWSNIGHT.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com


Aired December 20, 2004 - 22:00   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
AARON BROWN, HOST: Good evening, again, everyone. Pfizer, the drug company giant said today it was pulling all its consumer-directed ads for the pain reliever, Celebrex, in the wake of the study showing that in high doses, in high doses, it may cause an increased risk of heart attack or heart disease. First it was Vioxx. Then it was Bextra and now it is Celebrex. What Pfizer is not doing is pulling the drug completely off the shelves. It maintains it is normal or at least it works fine in normal doses, that it's perfectly safe when it's used as directed.
As you'll hear as we go along tonight, not everyone agrees with that. Pfizer's chairman, however, when we talked to him, said every study ever done, over a period of 10 years, has shown that at least where Celebrex is concerned, the drug is safe. You'll hear from him. You'll hear from the critics. But first, we need to do some background on the kind of drug that we're talking about and the tests done on it. So we begin with CNN's Elizabeth Cohen.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN CORRESPONDENT: We're all hearing just now that the drug Celebrex might cause heart problems. But Dr. Garrett Fitzgerald first noticed something might be wrong five years ago. That's when he saw something disturbing in his lab at the University of Pennsylvania, first in mice and then in humans. He noticed that Celebrex eased pain by blocking production of a certain type of fat, but that same kind of fat helped protect the heart.

DR. GARRETT FITZGERALD, UNIVERSITY OF PENNSYLVANIA: When you shut down this fat to alleviate pain and inflammation, you're exposing the cardiovascular system to hazard. So it's really a double-edged sword.

COHEN: Dr. Fitzgerald published his research and spoke about it at international conferences but he says the drug companies that make Celebrex and similar drugs called Cox 2 inhibitors, didn't pay much attention.

FITZGERALD: We thought this was something well worth pursuing. The companies involved at the time were somewhat dismissive.

COHEN: Pfizer, which makes Celebrex, says they did take Dr. Fitzgerald's study seriously and that many subsequent studies by other scientists showed there were no cardiovascular problems with Celebrex.

DR. GAIL CAWKWELL, PFIZER: We weighed the evidence and we found evidence both in people and in studies in animals that contradicted some of Dr. Fitzgerald's work.

COHEN: Dr. Fitzgerald says the experience with these pain relievers is a lesson in how a blockbuster class of drugs, heralded by some as wonder drugs, could come tumbling down. Vioxx was the first of the Cox two inhibitors to have trouble. It was taken off the market in September, after studies showed it could cause heart problems. Then last week, the "New England Journal of Medicine" published a letter from a group of researchers saying doctors should stop prescribing another Cox two called Bextra, again because of cardiovascular concerns. Days later, the National Institutes of Health released the news that people taking Celebrex were 2 1/2-times more likely to suffer a heart attack or stroke.

FITZGERALD: The entire experience with Cox two inhibitors is an example of blockbuster overreach.

COHEN: The three Cox two inhibitors earned $5.3 billion in sales last year, more than all over-the-counter pain relievers combined. Some say that's because Celebrex, Bextra and Vioxx were some of the most highly-marketed drugs ever.

(END VIDEOTAPE)

COHEN: Well, that was the middle of our Celebrex story. The moral of the story, what people say with these Cox two inhibitors, is that some researchers like Dr. Fitzgerald say that there was evidence relatively early on, when the drugs were first being marketed, that they could cause cardiovascular problems. And then, last week, a study from the National Cancer Institute that said, even at regular doses, even at doses that are recommended by Pfizer, that they can increase the risk of heart attacks and strokes by 2 1/2 times. And that, some people are saying raises quite a bit of concern. That's why, at the request of the Food and Drug Administration, Pfizer has pulled ads, ads like some of the ones you just saw in our story, have pulled those ads off the air and out of newspapers and magazines. However, the drug is still on the market. Aaron?

BROWN: OK. I've got one question on Celebrex. I need you to turn you to something else. OK? Viewers will hear this in a moment. But the CEO of Pfizer says that in all of the studies -- studies involving 40,000 patients, not only has Celebrex not shown itself to cause cardiovascular problems, but in fact, the reverse is true. So how does that square with what you're hearing, generally, about the problems of these Cox 2 inhibitors?

COHEN: The bottom line is that there have been so many studies on these drugs that some of this are contradictory. That's really the only thing that can be said right now. For example, last week, we all heard about this National Cancer Institute study that showed that regular doses that could increase cardiovascular risk 2 1/2 times. However, at the same time, Pfizer did a study that said that it didn't increase cardiovascular risk at all. They also didn't say that it protected the heart or that it protected you from stokes. They just said that it didn't seem to have any effect on heart health at all. So certainly if they're referring to a study that shows that Celebrex protects at all, that certainly wasn't the one. So what you have here is you have studies that contradict each other and Aaron, I'm going to look into my crystal ball, the one that you're about to ask me about is even more contradictory. So go ahead and we can talk about that other issue.

BROWN: I hate when you do that. Now, it's an over-the-counter drug which is the generic form of Aleve, I guess.

COHEN: Right. Aleve is an over-the-counter drug and the chemical in that is called naproxen. Naproxen is sold both as prescription and over-the-counter as Aleve and as other drugs. Now what happened today was that the Food and Drug Administration had a conference call with reporters and they said look, the National Institutes of Health has just done this study where some people were taking Celebrex. Some people were taking naproxen, which is Aleve. And the folks who were taking naproxen, they had a 50 percent increased risk of heart attacks and stroke, a 50 percent increased risk of heart attacks and strokes, when taking Aleve which, again, the chemical in that is naproxen.

Now interestingly enough, the folks who were taking Celebrex, they did not have any increased risk of heart attack or stroke. They just saw the problems in that study with naproxen. Now this of course has everyone scratching their heads. How could that be? The bottom line is that the FDA is now telling consumers if you're going to take naproxen, take it only for 10 days. Limit it to that. If you need pain relief beyond that, go talk to your doctor.

BROWN: Yeah. Elizabeth, thank you very much, Elizabeth Cohen down in Atlanta tonight.

One of the many questions raised by all of this, how did the link between all of these types of drugs, these Cox 2 inhibitors and heart attacks go unnoticed for so long? Why wasn't the risk detected before the drugs were approved? The answer may lie, in part, in how drugs get approved.

(BEGIN VIDEOTAPE)

BROWN (voice-over): For a drug company to win FDA approval for a new drug, it must first outline the studies it plans to conduct to test how safe and effective the drug will be.

ALAN GOLDHAMMER, Ph.D, ASSOC VP REGULATORY AFFAIRS, PHARMA: They have to register those clinical trials with FDA and FDA must give their assent before the clinical trials are started.

BROWN: This is a crucial step, according to Dr. Jerry Avorn, a professor at Harvard Medical School and author of "Powerful Medicines."

DR. JERRY AVORN, AUTHOR, "POWERFUL MEDICINES": The way we learn about drug side effects has everything to do with the way the companies set up the studies before they bring the results to the FDA. And of course it's the companies that do the studies of these drugs, not the FDA or other groups. BROWN: Dr. Avorn says how drug studies are designed may actually prevent problems from being detected. To begin with, he says, the study must last long enough.

AVORN: If you've got a side effect that isn't seen until after six months of using a drug, at all of the pre-approval studies only lasted for two or three months, you could easily miss that.

BROWN: Another crucial factor -- who participates in the study. Are the people enrolled in a clinical trial similar to those who will actually take the medication once it's approved and marketed? A study must also be large enough to uncover dangers. Say for every 5,000 people that take a drug, only one will develop the side effect.

AVORN: You're going to miss that if you're study only included 3,000 people and the side effect occurs only once in every 5,000.

BROWN: Once in every 5,000 may not seem like a lot. But when a drug is used by tens of millions of people, as Celebrex or Vioxx or Bextra have been, it's a much different picture, with potentially thousands of people at risk of being harmed.

(END VIDEOTAPE)

BROWN: Now, to the business side. Celebrex was one of the most heavily-marketed drugs in history. At least 26 million Americans have used it. It makes Pfizer a ton of money and its chairman is defending it at every turn. We talked with Pfizer CEO Henry McKinnell, late this afternoon.

(BEGIN VIDEOTAPE)

BROWN: Sir, you made a decision to stop marketing Celebrex on television directly to consumers. And here's what's curious about that to me. If you argue and you do, that the drug taken at a normal dosage level is still safe, then why stop the marketing of it at the consumer level?

HENRY McKINNELL, CEO, PFIZER: Well, we have a complicated message around safety to deliver here. I know it's confusing a great deal of people and we wanted to focus on communications with doctors and doctors' communications with patients and not have that cluttered by consumer marketing.

BROWN: Does any of this give you pause about this whole area of marketing directly to consumers, whether it's this drug or any other drug that you market to consumers on television and magazines and the rest?

McKINNELL: Well, some concern I must admit. What we're trying to do is convince patients to see doctors. The part of the message that we probably should be emphasizing is it is your doctor who has the full information around side effects and safety and efficacy and is the best person to make a judgment of what medicine is best for you. I think that needs to be emphasized in future direct to consumer advertising. BROWN: I want to move on from this and without beating this to death. What is seems to me in these ads, whether it's yours or others, you want me to go to the doctor and say what's this deal with Celebrex? Or what's this deal with -- fill in the blank. Not simply go see your doctor more often. That's not an unreasonable conclusion to draw, is it?

McKINNELL: I think that's right. And I think the part of the message that needs to be strengthened is that your doctor has full information on the benefits and risks of these products and you should discuss the best option for you with your doctor.

BROWN: Let's move on to the drug itself for a bit. You said the other day, you take it. You argued all weekend long. And I think there's been some supporting physicians who made the same argument, too, that taken at an appropriate consumer level, it's a safe drug. Do you have any concern, though, that as more studies are done, on the long-term use of these Cox two inhibitors, we're going to find that there's simply an unacceptable risk in them, despite the undeniable benefit?

McKINNELL: Well, we need to have confidence in the safety. We cannot compromise on safety. What seems to be missing in the whole discussion is that we have extensive clinical data around both the safety and the effectiveness of Celebrex in controlled clinical studies over 10 years, involving more than 40,000 patients, which show no risk of cardiovascular damage. We also have five published studies. And five out of the five of very large groups of patients, many in real-world settings from managed care groups, for example. Five out of five studies show no cardiovascular risk due to Celebrex. In fact the Celebrex-treated patients have less cardiovascular events than those patients receiving no treatment at all. We also have three long-term studies, two of which show no cardiovascular risk. This one study is not really consistent with everything else we know about this drug.

The one study being the one that caused you -- that has caused this whole uproar over the last three or four days. Do you think, by the way, just as an aside, that the uproar would be the same were it not for both Vioxx and Bextra coming under question?

McKINNELL: I think it would because so many people benefit from Celebrex, some 27 million Americans. Obviously, we need to be concerned with safety signals and this is a safety signal. What we're saying is we need to keep this in context with what else we know. And if you have questions about the use of Celebrex, your doctor's the best person to talk to.

BROWN: We know that going back years with Vioxx, there were -- I'm using this as a layperson, OK? There were some red flags. There were studies that showed heart incidents which Merck then said that really had more to do with the sort of non-aspirin effect, if you will, in the study. Have there been any studies in Celebrex that caused you to wonder, if there might be an increased chance of either heart disease, heart attack or stroke? McKINNELL: Well, actually just the opposite. The latest of these large studies was done by Dr. David Graham, the FDA whistle- blower. He looked at 1.4 million treatments in the Kaiser database. And he found at the highest dose of Vioxx, a three times risk, versus patients who received no treatment at all. Celebrex, on the other hand, had lower risks than any of the treatment options. And even had a lower risk, 0.86, than those patients in the study that received no treatment at all.

BROWN: Just a final question before we lose you, sir. And back to the beginning. Is it possible that the money, in its considerable millions that companies like yours and other drug companies spend on marketing, consumer marketing might be better spent on R&D?

McKINNELL: We spend more money on R&D than we do on marketing. But remember, we don't actually sell our products. All of the resources we put into quote, sales and marketing is really to make sure that physicians and patients are fully aware of all the information around the risks and benefits of the medicines we are offering. And then we leave it to the doctor and the patient to decide what is the best option for them.

BROWN: Sir, it's good to see you. It's I imagine a difficult few days. But you've been out there and I think those of us who do what I do for a living, appreciate that you've been out there. Thank you.

McKINNELL: Thank you, Aaron.

(END VIDEOTAPE)

BROWN: Thank you, CEO of Pfizer. In a moment, we'll consult with two doctors, Dr. Sidney Wolfe, Public Citizen, Dr. John Abramson, the author of "Overdosed America," who may see some of this a bit differently.

Later, we'll bring you up to date on one of the other stories that have people talking the last few days, a woman accused strangling a mother-to-be, then making off with her child.

Also the president's change of tone on Iraq after an especially rough weekend in the war. We'll take a break first from New York. This is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: More now on Celebrex and Bextra and the rest. A moment ago, you heard Henry McKinnell, the CEO of Pfizer. Here's a bit of what he had to say, it bears hearing again, about how drugs are sold or not, as the case may be.

(BEGIN VIDEO CLIP)

McKINNELL: Remember, we don't actually sell our products. All of the resources we put into quote sales and marketing is really to make sure that physicians and patients are fully aware of the -- all the information around the risks and benefits of the medicines we are offering. And then, we leave it to the doctor and the patient to decide what is the best option for them.

(END VIDEO CLIP)

BROWN: To the stockholder, the idea that the drug companies don't in fact sell drugs might seem odd. It wouldn't be the only oddity. The system is a strange cocktail of public and private. Some of the R&D Mr. McKinnell spoke about is done on the taxpayers' dime. Regulators leave the government and work for drug companies and vice versa. Doctors hand out samples like candy and people are supposed to ask their doctors, without asking their doctors, about any specific drug, certainly not the one we see in the commercial.

Where's a good doctor when we need one? We're joined by two. Dr. Sidney Wolfe of Public Citizen's Health Research Group and in Boston, Dr. John Abramson, the author of "Overdosed America" and it's good to have you both with us. Dr. Wolfe, just one quickie on Celebrex before we move on. Should it be on the market today?

DR. SIDNEY WOLFE, PUBLIC CITIZEN HEALTH RESEARCH GROUP: It shouldn't be and Pfizer's wishful thinking that by banning the direct to consumer advertising they can convince the FDA to keep it on the market is just wishful thinking. This drug is too dangerous to be on the market. Mr. Mckinnell is at the very least misleading, at the worst lying, when he tells people that the company doesn't sell drugs. Right after Vioxx came off the market, the company ran full-page ads in "The New York Times" and many other newspapers saying Vioxx is bad. Our drug is perfect good. Four years ago, an FDA physician looked at a very well-controlled, large study on Celebrex and said he was worried about the increased blood clots that were occurring with the drug.

BROWN: I'm sorry, let me get Dr. Abramson in here for a second. It is a bit -- I'm hesitant to say any guest on this program is disingenuous. But it was a bit disingenuous I thought to say as Mr. McKinnell said, that they're not out there selling drugs. My goodness, you have ads for drugs where they don't even tell you what they're for. They're just trying to implant the name.

DR. JOHN ABRAMSON, HARVARD MEDICAL SCHOOL: Aaron, you're absolutely right. Not only are they selling drugs to consumers by having these ads that make people look like they're enjoying activities that they couldn't enjoy otherwise, when we all know that Celebrex provides no better relief from arthritis pain. But the most important thing here is how the doctors have been misled. I think Mr. McKinnell is being a little bit dis -- well, he may be exaggerating a little bit when he says that Pfizer doesn't sell drugs. The report of the class study, which was the big study, 8,000 people with osteoarthritis, comparing Celebrex to older anti-inflammatory drugs. The results were reported in "The Journal of the American Medical Association." That report said Celebrex when taken for six months, causes fewer GI complications than the other drugs.

But the truth is, it wasn't a six-month study. It was a 12-month study. And the FDA had definitively rejected the company's argument to present just six months of the study. The full 12 months of the study shows that Celebrex provides no greater GI benefit than the older, far less expensive drugs. So now, we've got a cloud of cardiovascular risk hanging over this drug. What are the benefits? It's no safer. It's no more effective and it's far more expensive. So it's hard to see why fully-informed doctors and fully-informed patients would be buying $3 billion worth of this drug a year.

WOLFE: I agree...

BROWN: If I could insert one thing for people that haven't followed it this closely. One of the arguments in favor of these drugs as opposed to aspirin or ibuprofen or whatever is they cause less stomach problems, gastrointestinal problems. I hate to sound like the doctor. Now, Dr. Wolfe, you were about to say?

WOLFE: Well, as Dr. Abramson said, we knew four years ago that this idea that Celebrex protected the stomach was false. So we now have a drug that has unique risks. It causes an increase in heart attacks. It has no unique benefit either in terms of effectiveness or in terms of GI and it's still on the market.

We have a Web site called worstpills.org where we list 181 drugs that we think are too dangerous to use and safer alternatives. They include Vioxx, off the market now, Celebrex and Bextra, hopefully soon to come off the market and Crestor, a cholesterol drug. The problem is that neither the company, Pfizer or Merck or any of the other ones, nor the FDA are really doing an adequate job, warning or informing either patients or doctors. The FDA has pretty much stopped enforcing the laws and regulations on misleading advertising. Pfizer was caught just a few weeks ago making outrageous misleading claims on Viagra, their drug for impotence. So this is an industry that is desperate, that is doing everything possible to mislead patients and doctors and then saying we don't sell drugs.

BROWN: Dr. Abramson, just on this question of pain relief -- should I just take two ibuprofen and not worry so much about it? I mean is there anything out there that is truly, significantly more effective than what I can go to the drugstore and buy?

ABRAMSON: No. There isn't Aaron. In fact, the new drug application for Celebrex -- Celebrex was tested against two Advil tablets, exactly what you're saying, for dental pain. And two Advil tablets provided significantly better relief than all doses of Celebrex that were tried. So actually you're two Advil tablets are superior in terms of providing pain relief.

BROWN:Is the industry so big and so powerful at this point that it can -- get away with it sounds a little more nefarious than I mean. But that can get away with it? Is that right?

WOLFE: I think that's true. In Washington, there are more drug industry lobbyists in Washington over 600, than there are members in Congress. They push the Congress away with lobbyists, with campaign contributions and so forth. And the FDA, which is technically part of the Public Health Service, is getting hundreds of millions of dollars in cash directly from the industry, to help them regulate drugs. What it does help them do is be kinder to the industry. Kindness on the part of the FDA to the drug industry, translates into increased risk to patients though.

BROWN: Let me give, Dr. Abramson the last word. We were chatting just before we went on the air. This -- a lot of things that happened in a short period of time with Vioxx, Bextra and Celebrex. Are we at one of those moments, where policy may, in fact, be changed or will it do you think just pass?

ABRAMSON: No, I think we're there, Aaron. I didn't think we were going to get there when it was just Vioxx. But I think now with Celebrex, people are starting to get the idea that the real crisis in American medicine is that even the most disciplined, dedicated doctors, can no longer get accurate information. Because the drug companies have so much influence over what we believe the best medical care is. I think the American public is now getting the picture. And this problem is fundamentally not a scientific problem. It's a political problem.

BROWN: Gentlemen, good to have you with us. We appreciate your time. Have good holidays. Thank you.

A couple more items before we head to break or medical school as the case may be. It sort of feels like that tonight. The first promise is to simplify life for AIDS patients who now take four anti- viral drugs a day or more. Today two competing drug companies said they'll pool their resources to create a single pill that does the work of three.

Also today, the Food and Drug Administration approved a rheumatoid arthritis drug Remicade for treating a crippling spinal disease, alchalozians fondalitis (ph). This is in fact in the medical sense, changes very little. Doctors had been prescribing it off- label, as it's called. But FDA approval means it is now more likely that insurance companies will pick up the tab, which can run $1,000 or more per month.

Just ahead -- the proofs of the latest arson investigation, in the history of the state of Maryland.

And a president goes on the offense to protect the man in charge of the defense, if you will. We take a break first from New York. This is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: November was a bad month. We're a month behind, still.

No Americans lost their lives in Iraq today. That's good news. Two Americans, however, died in Kuwait City, a traffic accident over the weekend. But there have been no American combat fatalities in Iraq since last Thursday, good news, but by no means the only news. Another car bomb went off this afternoon in Karbala, wounding several, but killing none, unlike the two bombings yesterday, one in Najaf, one in Karbala, which killed at least 66 people, police today rounding up dozens of suspects, Iraq's prime minister calling the attacks a deliberate attempt to widen the divide between Iraq's Sunni and Shiite communities.

And, in Washington, the president acknowledged as much and more. The bombers, he said, are having an effect on the upcoming election preparations, but also on the larger mission. The president said what he said in his second press conference in six weeks, which, frankly, is a lot for him. It took place with public doubts about the war growing and confidence in his defense secretary slipping.

It was also to many ears somewhat of a departure in tone and content from what the president had been saying about Iraq during the campaign.

So, from the White House tonight, CNN's Dana Bash.

(BEGIN VIDEOTAPE)

DANA BASH, CNN WHITE HOUSE CORRESPONDENT (voice-over): The president was strikingly candid about a problem in Iraq. The effort to build up its army so American troops can start coming home is not going to plan.

GEORGE W. BUSH, PRESIDENT OF THE UNITED STATES: I would call the results mixed, in terms of standing up Iraqi units who are willing to fight. There have been some cases where, when the heat got on, they left the battlefield. That's unacceptable.

BASH: One goal of the end-of-the-year news conference was to talk up Iraq's progress. But he also conceded this about a spike in suicide bombings.

BUSH: No question about it. The bombers are having an effect.

BASH: Mr. Bush stood firmly by his embattled defense secretary, whom critics call responsible for Iraq policy failures. Rumsfeld's been most recently under fire for ignoring pleas for more armored vehicles in Iraq, and using an auto-pen, not his own hand, to sign letters for families of troops killed there.

BUSH: I have seen the anguish in his, or heard the anguish in his voice and seen his eyes when we talk about the danger in Iraq. You know, sometimes, perhaps, his demeanor is rough and gruff, but beneath that rough and gruff, no-nonsense demeanor is a good human being.

BASH: The president expressed disappointment but no regret for the ill-fated choice of Bernard Kerik for homeland security secretary, offering a veiled nod to critics of the White House vetting process.

BUSH: The lessons learned is continue to vet. And ask good questions.

BASH: Controversy over Kerik and Rumsfeld may already have dimmed the president's postelection glow. A new CNN/"USA Today"/Gallup poll shows his approval rating back below 49 percent, down 6 points in just a month. Bush aides understand building up his standing is crucial to pushing second-term goals, like reforming Social Security. There, the president deflected questions on specifics, beyond wanting private accounts for younger workers.

BUSH: I'll propose a solution at the appropriate time, but the law will be written in the halls of Congress.

BASH: Dana Bash, CNN, the White House.

(END VIDEOTAPE)

BROWN: Another batch of government documents obtained by the ACLU is causing a stir tonight, among them, an e-mail sent from an FBI agent in Iraq to senior bureau officials back home. In it, the agent repeatedly refers to an executive order authorizing certain harsh methods of interrogation. The methods include sleep deprivation, the use of hoods and dogs. The White House today said no such order exists. There were denials, too, from the FBI, the Justice Department and the Pentagon.

Intuition tells you that, in a bad economy and in a time of peace, military recruiting is a whole lot easier than it is in an improving economy and a time of war. Intuition in this case would be right. And compounded by the fact that so many people who might join the Reserves these days are stay in the Reserves are not, because they've either been to Iraq and had enough or want to avoid the war in the first place. So, is there a crisis in the reserves? Depends on who you ask.

(BEGIN VIDEOTAPE)

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: I'm the guardian of freedom.

UNIDENTIFIED FEMALE: And the American way of life.

(END VIDEO CLIP)

BROWN (voice-over): The ads no longer sell the National Guard as one weekend a month and two weeks in the summer, not when the part- time soldiers of the Guard and Reserve, make up some 40 percent of the troops toughing it out these days in Iraq.

The National Guard announced last week that it was sending out more recruiters and dramatically increasing enlistment bonuses, especially for those with military experience. And today, the Army Reserves did the same. They both missed their recruiting goals the past two months, the Guard by almost a third. And the commander of the National Guard admits these days it is a tough sell.

LT. GEN. STEVEN BLUM, NATIONAL GUARD CHIEF: The economy is recovering. We're a nation at war. Service in the National Guard means not if you're going to stay in your fair rotation overseas or here at home, but when that rotation will occur. BROWN: A major problem is that many seasoned troops, leaving the regular Army, are no longer entering the Reserves, seeing them as just a return ticket to Iraq. Outside observers, including a former defense secretary in charge of man power, bluntly now, are predicting a crisis.

LAWRENCE KORB, SENIOR FELLOW, CENTER FOR AMERICAN PROGRESS: Because your next troop rotation is scheduled this spring, if you still need 150,000 troop there, you're going to have to call up more Reserves. You're also going to have to send a lot of active duty people back who haven't had very much time at home. And when those people come back, then they're simply not going to stay.

BROWN: Korb says that, where new technology in the Air Force and the Navy is allowing those branches to actually cut their numbers and it's too early to tell the effect of the occupation on the Marines, the effect of longer and more frequent deployments on the Army is clear and a concern.

KORB: You will begin to break the force in the sense you'll lose you're senior noncommissioned officers, your warrant officers, your middle-grade officers, your captains and majors.

BLUM: We're finding that this war is actually stretching the National Guard. And we're getting to be a more capable, more effective and more competent force.

BROWN: The regular Army announced new recruiting incentives back in August and says it is now meeting its goals. Critics say that is only possible with lowered standards and early inductions and that the real problem is, the military is simply too small for its new responsibilities.

JOHN ALLEN WILLIAMS, LOYOLA UNIVERSITY CHICAGO: We have a military that's good enough to take down a regime, but not large enough to do the kind of peacekeeping tasks and the reconstruction tasks that are necessary to actually win the war.

BROWN: All agree it is not an issue of patriotism. Americans continue to sign up and serve. But under the relentless pressure of Iraq, it may turn out to be a case of simple exhaustion.

(END VIDEOTAPE)

BROWN: Still to come on the program tonight, if you think your morning commute is bad, be thankful you don't have to drive through Volusia County, Florida. You will get the picture.

And if you don't have time to read the papers before taking off to work in the morning, why, we'll do that for you, more or less.

We'll take a break first. Around the world, this is NEWSNIGHT.

(COMMERCIAL BREAK)

BROWN: Police in Maryland now have a fifth man in custody in connection with a string of house fires that did about $10 million damage to a subdivision just outside the nation's capital. Sources say this fifth suspect is an acquaintance of the other four, one of whom was a security Guard for the complex. As for motive, lots of speculation, but nothing solid.

Kansas next. The woman accused of strangling a pregnant woman and cutting the fetus from her womb made an appearance in federal court. The judge is reading the charges against Lisa Montgomery, kidnapping and murder, capital offenses. Ms. Montgomery kept her eyes downward the entire time, said nothing. Her husband spoke with local news crews outside the courthouse.

(BEGIN VIDEO CLIP)

KEVIN MONTGOMERY, HUSBAND OF LISA MONTGOMERY: My heart ain't broke just for me and Lisa and her kids. It's them, too. That was a precious baby. I know.

(END VIDEO CLIP)

BROWN: Pretty heartbreaking story. Ms. Montgomery's next court appearance is scheduled for Thursday.

Got a little behind tonight. Need to take a break. Ahead on the program, what a doll. Or, is it, what? A doll?

(BEGIN VIDEO CLIP)

DAVID HORVATH, CREATOR, UGLY DOLLS: I would love to be called ugly, because, to me, ugly means OK with being yourself and being different.

(END VIDEO CLIP)

(COMMERCIAL BREAK)

BROWN: News, we say, is supposed to be a search for truth, and art, the pursuit of truth and beauty. So, where does that leave business? Well, sex does sell. And a pretty face never hurts. But for one growing business, ugly is pretty good, too.

(BEGIN VIDEOTAPE)

HORVATH: Hi there. I'm David Horvath. I'm the creator of the Ugly Dolls. And welcome to the Ugly Doll warehouse. Welcome to ugly town.

Ugly Dolls started as a sad story. My girlfriend, Sun-Min, had to go back to Korea right after we graduated. So I would send you these miss-you letters with Wage at the bottom. And, for a Christmas gift, she sent back a plush version of him that she had hand-sewed for me as a gift. I showed that Ugly Doll to a friend of mine who owns a Giant Robot store in Los Angeles.

And he said, oh, these are great. I'll take 20 of them. I want to put them in my shop. So, we made a few more and dropped them off at the store. And they sold out in one day.

Thanks to the Ugly Dolls, actually, we were able to reunite about a year ago. And we plan to marry next year. It's just a play on words, really. There is no ugly, we think. And when they actually feel them and you get them closer to you, they don't seem so ugly at all and they're quite endearing.

Well, it definitely starts as many sketches. I'll whip up 100 different sketches and pass them over to Sun-Min. And she'll kind of take an eyeball from this one and some legs from that one and in some cases, Completely throw away my bad drawings and come up with her own.

There's nine right now, with a newborn on the way. There's Wage. And he's the first Ugly Doll. He's our orange guy with the apron on. Then, there's Babo, who is the baby, loves cookies. There's Tray. Tray is our girl. There's Target, who is the grandpa. There's Cinko, our hydrophobe. Then we've got Jeero, our macho guy. We have got Wedgehead and Ox, our naughty boys. And then there's Ice-Bat, the cold-weather pet. He lives in an ice box. And everything he touches turns to ice.

For me, it's just a lot about storytelling. The toys today, they seem to do everything for you. And everything has these incredible super-robotic features. But we just wanted to create something very simple and honest that leaves a lot to the imagination.

I would love to be called ugly, because, to me, ugly means OK with being yourself and being different. We're all very different, right?

To see the reaction of the kids at PS3, that was just incredible. We love it that adults are so into the Ugly Dolls. But to hear from kids that they really identify with the characters, it sends a really great message out there.

UNIDENTIFIED FEMALE: My Ugly Doll, I'm -- sort of what I'm like.

HORVATH: You can find them anywhere, from Barney's in New York, the Design Museum in London, to little mom-and-pop toy shops all across the country. They are our little children. But we like them to be your little children, too.

Bye-bye, Babo. Have a good time. Have a safe trip.

(END VIDEOTAPE)

BROWN: The work of NEWSNIGHT producer Mary Anne Fox (ph).

Still ahead on the program, a little news, a little weather, a little traffic. Traffic? Yes, traffic.

Break first. We'll be right back.

(COMMERCIAL BREAK)

(ROOSTER CROWING) BROWN: Okeydoke, time to check morning papers from around the country, around the world. There are so many I like today. We'll see how many we get done.

"International Herald Tribune." "Some Iraqi Forces Not Ready, Bush Says. He Warns Against Expecting Quick Exit. Rumsfeld Backed as Good and Decent Man." That is the correct lead, in my humble opinion, the president saying Iraqi forces not ready.

However, "The Washington Times" didn't think so. We often disagree, I think. "Bush Presses For Reform on Border Policy, Says Illegals Fill Unwanted Jobs." That's a big story to that newspaper. And, therefore, they made it their lead. It's their paper. They get to do what they want. "District Close on Stadium Deal. Cropp, Williams Discuss Compromise." I'm sure that the District will cave in to the wishes of Major League Baseball. It's just the way it always works. There goes my job as commissioner.

"Chattanooga Times Free Press." I like this story. "Interrogations in Iraq Beyond FBI Standards." Everybody is denying the president signed this executive order, except some FBI agent says he saw it. There you go. "Anniston Ramps Up 24/7. Workers Weld Armor For Humvees." The "Chattanooga Times Free Press" reporter really started this whole thing on the armor. And they are going to town on it. They are not letting go of this story, which is what you do if you got yourself a story.

"Boston Herald." "Tanker Attack Would Destroy Hub." Well, there's your uplifting pre-Christmas headline for you. And, by the way, you can take their greedy celeb quiz. I will not be a part of that.

"The Philadelphia Inquirer." Uh-oh, it's stuck. How we doing on time? Thank you. "Philadelphia Inquirer." "Bush Critical of Iraqi Forces." As we say, that is the right lead. But their big story, "Oh, the Pain. Owen's Season Likely Over," this Terrell Owens, or T.O., as I call him, hurt his leg. And, actually, they give you a -- this is how big a deal this is in Philadelphia. They give you a diagram of how he and where he hurt himself. Anyway, he's going to have surgery. And there goes that season, or maybe not. You never know. The good ones play hurt. I do.

"San Francisco Examiner." "City Will Seek $500,000 Fine Against PG&E." The paper almost always leads local.

Let me do this one and then we'll do the weather. "Cincinnati Enquirer." "White Christmas a Very Good Bet." I don't know if it snowed where you are, but it snowed where I am today. It snowed in New York. And it was cold.

Speaking of which, the weather tomorrow in Chicago, "ominous." Hmm.

Speaking of which, ominous things in Florida, we'll show them to you when we get back.

(COMMERCIAL BREAK)

BROWN: Bill Hemmer with a look ahead at tomorrow's "AMERICAN MORNING."

(BEGIN VIDEO CLIP)

BILL HEMMER, CNN ANCHOR: Aaron, thanks.

Tomorrow on "AMERICAN MORNING," Howard Stern says it will be the death of FM radio. But is Sirius satellite radio really all that? We'll talk to the man who is banking on it, the CEO, Mel Karmazin, one of the people who made the biggest impact on 2004. Our series is called "They've Got the Goods." And it continues tomorrow. See you at 7:00 a.m. Eastern time on "AMERICAN MORNING" -- Aaron.

(END VIDEO CLIP)

BROWN: Bill, thank you.

We give you Chicago's weather every night, but rarely do we do the traffic report. Tonight, we couldn't resist, showing what a mess it is, or will be at least, tomorrow, in Deltona, Florida. Take a look. A 12-floor sinkhole -- that's probably a 12-foot sinkhole -- that formed Saturday is more now than 225 feet deep.

Man, you got to run into the ocean or something to get that deep. Civil engineers say it could be a week before the hole stops growing. That's what they said about me, too. About 25,000 drivers are going to have to find an alternate route until this gets fixed. There you go, traffic and weather together on NEWSNIGHT.

Just -- you can't resist a good sinkhole story. I don't care how sophisticated you are. It's just something you can't resist.

Good to have you with us. We're all back tomorrow. "LOU DOBBS TONIGHT" next for most of you.

Until then, good night for all of us at NEWSNIGHT.

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