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PAULA ZAHN NOW

Is Celebrex Dangerous? Uncle of Michael Jackson Accuser Speaks Out; Country Singer Runs for Governor of Texas

Aired December 17, 2004 - 20:00   ET

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


PAULA ZAHN, CNN ANCHOR: Good evening, everyone. Thank you for joining us. Glad to have you with us tonight.
A pain pill caused a lot of pain today. And tonight, I will take your questions about Celebrex right to the top. The head of Pfizer, the company that makes the pill and is leaving them on the market, is among my guests.

Until today, Celebrex has been one of the drug companies' biggest success stories, both medically and financially. But this example of better living through chemistry may have a downside. A new study says that some people on Celebrex may have more than doubled their risk of serious heart problems.

(BEGIN VIDEOTAPE)

ZAHN (voice-over): We've seen the ads.

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED ACTOR: With Celebrex, I will not settle for part- time relief.

(END VIDEO CLIP)

ZAHN: Millions of you take the pill. Celebrex has been prescribed to 27 million Americans. They go for more than $2 a pop, so Pfizer makes a lot of money from them, sales of nearly $2 billion last year alone. And it's making even more, now that Merck's rival drug Vioxx has been taken off the market.

In just October alone, Celebrex rang up $260 million in sales. Both Celebrex and Vioxx are in the same class of drugs, called COX-2 inhibitors. In plain English, they block an enzyme that causes swelling, which causes pain. But there may be a deadly side effect.

DR. JOHN ABRAMSON, HARVARD MEDICAL SCHOOL: One of the two studies that Pfizer is doing with the drug Celebrex shows that Celebrex doubles the risk of heart attacks. Other studies that Pfizer has done have not shown that.

ZAHN: Pfizer sells a similar drug called Bextra. A government panel is set to review the current data on all COX-2 inhibitors early next year.

Today's news gave investors a heart attack. Pfizer's stock nosedived more than $3 a share. Today's news also provoked a media frenzy, complete with doctors dispensing free advice.

DR. MARIE GRIFFIN, VANDERBILT UNIVERSITY: I think for people who are at high risk of heart disease, there's more of an immediate -- you know, they need to do something right away.

ABRAMSON: We're not sure. We need to be in a wait-and-see mode here.

ZAHN: So how do you know if your heart can take the wait?

(END VIDEOTAPE)

ZAHN: And the CEO of Pfizer, Hank McKinnell, joins us now.

HANK MCKINNELL, CEO, PFIZER: Paula, good to be with you.

ZAHN: Thank you.

So why, even with the evidence you released today, are you keeping Celebrex on the market?

MCKINNELL: Well, let's keep the evidence we released today in context.

We released the results of two cardiovascular specialists' review of two studies, one that showed in a large-scale, well-controlled study of two to three years continuous treatment at two to four times the recommended dose cardiovascular risk equal to placebo. That was a good study. We also reported the results of a second study with dosing also over two to three years continuous treatment at four to eight times the recommended dose that did show an elevated risk.

But that's not consistent with the first study, nor is it consistent with the great body of evidence that we have of the safety and efficacy of Celebrex when it's used as recommended.

ZAHN: But the bottom line is that Vioxx was removed from store shelves, and in the same day that happened, your company said -- quote -- in a press release -- "Pfizer is confident in the long-term cardiovascular safety of Celebrex." That was 2 1/2 months ago. Were you not aware of this second study coming out that you've addressed today?

MCKINNELL: We learned the results of this special review, which we encouraged with the National Cancer Institute, at 5:00 p.m. last night.

ZAHN: So, are you telling me tonight that any patient taking Celebrex should feel 100 percent degree comfort level knowing that the studies are mixed?

MCKINNELL: Paula, no medicine is ever 100 percent safe. Any agent powerful enough to do good is also powerful enough to do bad. It's that balance of risks and benefits that the prescribing physician, fully informed -- that's why we release this information as rapidly as we did -- with the patient decides what's in the best interests of the patient.

ZAHN: I really want our consumers to understand what they're supposed to think. I know you think that the overwhelming evidence indicates that this drug is safe to take, but here you've got the National Cancer Institute doing a long-term study pointing to an increased risk of cardiovascular problems if you use Celebrex.

MCKINNELL: At four to eight times the recommended dose for osteoarthritis and continuous dosing over a two- to three-year period. That's not the way these drugs are used by arthritis patients.

ZAHN: Sir, how worried are you about how this might affect your company's bottom line?

MCKINNELL: I have no idea what the impact of this will be on the company. I think that will be determined by the decisions of tens of thousands of doctors prescribing the best medicine for their patients.

ZAHN: And you understand why they might be queasy about this tonight?

MCKINNELL: Well, I'm queasy myself. But, Paula, in addition to being the CEO of Pfizer, I'm also a Celebrex patient. And I'm not changing my medication.

ZAHN: Hank McKinnell, we very much appreciate your time tonight. Thanks for joining us.

MCKINNELL: Thank you, Paula.

ZAHN: And still ahead, I'll talk with a man who says he had a heart attack while he was taking Celebrex.

The Food and Drug Administration has issued a written statement about the new research and the Celebrex controversy. Part of it says: "Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. The FDA advises evaluating alternative therapy. At this time, if physicians determine the continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex."

There's a lot more ahead, including the extreme lengths drug companies go to, to get your attention.

(BEGIN VIDEOTAPE)

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED FEMALE: Can I tell you a secret?

(END VIDEO CLIP)

ZAHN: They seem to know just where it hurts.

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: Why do I have to suffer with headaches like this?

(END VIDEO CLIP)

ZAHN: And they tell you exactly what to do.

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED FEMALE: Talk to your doctor.

(END VIDEO CLIP)

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: Don't let acid reflux eat at you.

(END VIDEO CLIP)

ZAHN: But are all these ads creating a nation of hypochondriacs?

And the Michael Jackson case back in court. Could past allegations about sex abuse be used as evidence against him?

That and more as PAULA ZAHN NOW continues.

(END VIDEOTAPE)

(COMMERCIAL BREAK)

ZAHN: When it comes to prescriptions, your doctor is supposed to know best. But listen to this. Pfizer spent nearly $96 million last year advertising Celebrex directly to you, the consumer. So, who are you going to believe, a TV commercial or your doctor?

Medical correspondent Elizabeth Cohen looks at the marketing of medicine.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT (voice-over): They call her Dot. And Dot has done great things for sales of the antidepressant drug Zoloft.

VAL DIFEBO, DEUTSCH INC.: What we thought was important here was to have dot communicate to people how Dot was feeling.

COHEN (on camera): And did Dot work?

DIFEBO: Dot works. Dot works.

COHEN (voice-over): And the dancing Viagra men work. And the come-hither woman works. And the cute bellies work. One study from a health care policy think tank shows, every $1 the pharmaceutical industry spends on drug advertising to consumers yields about $4.20 in sales. These days, people know the names of what they see on TV.

UNIDENTIFIED FEMALE: Zocor, Lipitor. UNIDENTIFIED MALE: Through's one called Cialis.

UNIDENTIFIED MALE: A sleep one I see all the time, Ambien.

UNIDENTIFIED FEMALE: Zoloft, that's the cartoon bubble that smiles and frowns and bounces around.

UNIDENTIFIED FEMALE: Penile dysfunction, there are always couples cavorting romantically.

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: Cialis is here.

(END VIDEO CLIP)

COHEN: The aim, to saturate you with tried and true marketing techniques like sex and fear on TV, in magazines, even while you're watching car racing or the Poker World Series.

DIFEBO: You're going to see them when you wake up in the morning and when you go to bed at night, because we know that's where you are. And we want you to see these ads.

COHEN: Val DiFebo's advertising agency developed the Dot campaign and several other pharmaceutical ads.

DIFEBO: I would say drugs have become part of the fabric of our lives. They're a part of maintaining a healthy lifestyle, the same way exercise is, the same way, you know, being with your family and being happy are.

COHEN: But all of this has some people worried that it's created a nation of hypochondriacs, where everyone who sneezes thinks they have allergies, where everyone who had a bad night's sleep asks their doctor for a prescription.

(BEGIN VIDEO CLIP)

BILL MAHER, COMEDIAN: Tell your doctor. Tell your doctor? When you tell your doctor, isn't he just a dealer at that point?

(END VIDEO CLIP)

DR. ROBERT GOODMAN, COLUMBIA UNIVERSITY: It's creating illness where none previously existed.

JOSEPH CALIFANO, FORMER HEALTH SECRETARY: We're also making a lot of people think that there's a pill for anything that -- there's a pill for any problem they may have. And if you just get your doctor to prescribe it for you, if he won't prescribe it for you, he is the bad guy.

COHEN: Many doctors have a hard time saying no.

CALIFANO: Doctors don't like to lose patients any more than anyone likes to lose a customer.

COHEN: The pharmaceutical industry says it's helping people.

LORI REILLY, PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA: We know that about 24 million people since 1997 have gotten diagnosed with a condition for the first time as a result of seeing a direct consumer advertising.

COHEN: And those ads are for some of the most expensive drugs on the market. Dr. Bob Goodman says patients are disappointed when he tells them the drug they saw on TV is told is not right for them or that there's a less expensive, generic drug that would work just as well.

GOODMAN: You talk about disappointment is when patients sees a generic drug written on their prescription when they came asking for something else. That's disappointing.

COHEN (on camera): They don't want the generic.

GOODMAN: No.

COHEN: They want what they saw on TV.

GOODMAN: They want the name brand.

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED FEMALE: With Celebrex, I will not stop at nine when I really want to play 18.

COHEN: Who wouldn't want to be this happy? So either these ads are helping sick people seek treatment...

(BEGIN VIDEO CLIP, AD)

UNIDENTIFIED MALE: Wouldn't you like to try it?

UNIDENTIFIED MALE: Why, yes. Yes, I would.

(END VIDEO CLIP)

REILLY: It's getting people treated for conditions they weren't aware of in the past. That's a positive health step forward.

COHEN: Or the ads are convincing healthy people they should take drugs they don't really need.

(BEGIN VIDEO CLIP, AD)

NARRATOR: Think aspirins and heart medications alone are enough?

(END VIDEO CLIP)

COHEN: You decide.

(END VIDEOTAPE)

ZAHN: So, what do you do if someone you know is taking Celebrex?

Joining me now, medical correspondent, Elizabeth Cohen, whose piece you just saw, and Dr. Steven Abramson, chief of rheumatology at the Hospital For Joint Diseases and the associate dean at New York University of Medical School. Dr. Abramson was on the committee that helped oversee FDA approval of both Celebrex and Vioxx.

Good to see both of you.

Doctor, how many people in America are actually bypassing or trying to bypass their doctors to get Celebrex for something they see in the ad they think they may need it for?

DR. STEVEN ABRAMSON, HOSPITAL FOR JOINT DISEASES: Well, I think people are excited. We're excited about this drug because it was effective. It is effective. And it's safer on the stomach than most of the other drugs that we had that were comparable.

So there was an unmet need, especially for people who had ulcer disease and who were at risk to bleed. So there was a reason for this drug to become very popular in the population.

ZAHN: You keep on saying in the past tense was, which would indicate to me that you are concerned about one of the two studies that was presented to the public for the first time from the National Cancer Institute.

(CROSSTALK)

ABRAMSON: Right. Well, I didn't mean to use the past tense, particularly...

ZAHN: But you did, three times.

ABRAMSON: I did. I did.

No, I think this signal needs to be looked at carefully, because there is always a possibility that these COX-2 inhibitors may cause heart disease. But I think, having seen all of the data with Celebrex, it's not clear and convincing yet that this signal is sufficient to indicate that there's a cardiovascular risk at the normally used doses, because these were very high doses that were used.

I've seen all of the data from the time came to the FDA in 1998. And, in general, all of the data for Celebrex has been very clean with regard to cardiovascular risk. In fact, David Graham's study in Kaiser, the one that caused the big uproar at the FDA, because he felt that it was being withheld by the FDA, that study in Kaiser showed that Celebrex had a lesser risk of heart disease than people on placebo.

ZAHN: All right, so now I'm really confused.

ABRAMSON: Yes.

(CROSSTALK)

ZAHN: How are we supposed to look at these two studies, the one good one for the company and the one bad one for today? You're a patient out there.

ABRAMSON: I think the logical way to do this is be very careful about how you prescribe any drug for a patient, which means that if a person has a risk for G.I. bleeding, where these drugs have saved lives, and they don't have any risk for cardiovascular disease, then I think Celebrex is still a very reasonable choice.

On the other hand, based on this recent study, if a person has a risk for heart disease, I would be a little bit more -- I would not use the drug right now, certainly without using aspirin with it. So, I think you pick your risk. And this is a safer drug if you have ulcers, and perhaps not a safer drug if you have heart disease.

ZAHN: Pretty tough medicine, Elizabeth Cohen. You pick your risk.

You talked with a bunch of doctors about this, as well as patients. What seems to be the prevailing reaction to this, and what do they plan to do about it?

COHEN: Well, I think one of the interesting things, Paula, is, the doctor mentioned dosing. Let's talk about that for a little bit.

What the study from the National Cancer Institute found is that people who were taking 400 milligrams were at 2.5 times increased risk of having a heart attack or stroke. Well, 400 milligrams is not a very high dose. Pfizer recommends 400 milligrams for several conditions. In fact, sometimes, it even recommends 600 milligrams for some conditions. So, in fact, these are dosages that regular people are taking every day.

ZAHN: So, how are they supposed to react to this study, then? Are you supposed to cut back these dosages?

COHEN: Well, what the Food and Drug Administration is saying to doctors today is, look, if a patient comes to you, is taking Celebrex and says, what should I do, you should tell -- you should think about, are there other pain relievers that would work just as well for this patient? And if you really decide that Celebrex is really the way to go, you want to use the lowest possible dose that you can use that can still help that person.

That's from the Food and Drug Administration. They really emphasized today that doctors need to think about alternatives to Celebrex when a patient comes to see them.

ZAHN: And so do patients, except they're inundated with these commercials. Do you think the patients are really familiar with what other alternatives are out there?

(CROSSTALK)

ABRAMSON: Right.

So, I think that patients need to depend on their doctor to filter the information they come to the doctor with. Now, a very important issue is that the other drugs that the FDA says might be preferred also have their own toxicities. In fact, there's a recent study that even Motrin or Advil may increase the rate of heart attack if you're taking aspirin.

So we have to look at this in the context of how many drugs have been subject to thousands of patients treated in a prospective, controlled placebo trial. And I think one of the hazards is, if you switch to another drug, is that drug really safe and what is the overall safety between drug X and drug Y? And I think this still has to be sorted out.

(CROSSTALK)

ZAHN: You know, that's quite a conundrum for all of us, I think, as we're hearing both of you talk tonight, a lot to sort through.

Doctor Steven Abramson, thank you for your time. Elizabeth Cohen, yours as well. Thanks.

CNN will have much more on the safety of Celebrex tomorrow on a special live "HOUSE CALL" with Dr. Sanjay Gupta at 8:30 Eastern. Elizabeth Cohen will get up early. She will sit in for Sanjay and will talk with experts abortion drug and take your e-mail questions. Just send them to housecall@CNN.com.

And that brings us to our PZN. That would PAULA ZAHN NOW meter. Have you ever asked your doctor for a drug you saw advertised? Log on to CNN.com/Paula and tell us. The results a little bit later on in this hour.

Ads that urge you to ask your doctor for a certain drug are one thing. When we come back, a CNN investigation: Are some drug companies crossing the line so doctors will write more prescriptions?

(COMMERCIAL BREAK)

ZAHN: Welcome back.

We have heard from lots of doctors today, but what about patients? Joseph Buser suffered a heart attack while he was using Celebrex. He is now suing Pfizer. He is joined by his attorney, Robert Sullivan.

Welcome to both of you.

JOSEPH BUSER, FORMER CELEBREX USER: You're welcome.

ZAHN: Captain Buser, I don't think you just heard my last conversation with the CEO of Pfizer. But basically he said that the overwhelming evidence points to the fact that Celebrex is in fact safe, and he's going to continue to take it. Your reaction?

BUSER: I think he's a fool. That's all I can say. My whole life has been turned upside down as a result of what happened to me. I was about to have a C.D. released to be a hip-hop artist three years ago. I was filming music videos and dancing. Now I can't walk without a walker. And the only thing the doctor prescribes is a wheelchair.

I need hip surgery. No doctors will do it because they're afraid to operate. They're afraid I'll die on the table as a result of the damage to my heart, which occurred sometime in the last year while I was taking 400 milligrams a day of the Celebrex.

ZAHN: What evidence is there that it was just the Celebrex alone that you think has caused you to decline?

BUSER: The only thing I as a layman can say is that three years ago I was walking and dancing and carrying on fine. And now I've been told I have had a heart attack and there's 10 percent permanent damage to my heart. And the orthopedic surgeon says he refuses to operate because that damage is there on my heart. And it wasn't there a year ago.

ZAHN: Mr. Sullivan, how are you going to prove that this weakness was caused which Celebrex and the damage to Mr. Buser's body?

ROBERT SULLIVAN, ATTORNEY FOR BUSER: No history of heart problems in his family, no history of heart problems or blood pressure or anything like that with respect to him.

And once the heart attack occurs, all the tests, if he needed a triple bypass, if he needed stents, if he had clogged arteries, if he had anything that would have caused that heart attack, we could accept that. But he had none, no stents, no bypasses, no problems at all.

BUSER: No, because I had an angiogram and it showed no need for stents or bypass whatsoever.

ZAHN: Are you surprised the company is keeping Celebrex on the market? They're awaiting yet another FDA trial in six weeks or so.

BUSER: I cannot understand it. It's -- like so many things, it's unbelievable. In this day and age, that this country would allow such a thing., I don't understand how it could go on and be allowed.

ZAHN: Now, our last guest was a man who was actually involved in some pivotal studies, a doctor with both Vioxx and Celebrex. And he was saying that the picture is far more complicated even maybe than you might pointing to tonight with dosages and the impact those dosages ultimately have on the body and what you're being treated for.

SULLIVAN: Here is why it's not complicated.

It's complicated as to whether or not you should take the drug. I understand that. But they knew about this two years ago. The FDA study pointed out problems with Celebrex in February of 2004. They come on here and they say, if you believe that they just learned about this at 5:00 last night, then you're ready to believe in Santa Claus in 10 days.

It's absurd that they just learned about this last night. And they should have told the American public, for example, like Viagra did. Here's a drug. There are risks to it. These are the risks. Now you make the decision. He has a right to make a choice.

ZAHN: All right, gentlemen, you tell a powerful story. And I'm sure there are a lot of people that will dispute what you're saying tonight. But it really is a mess for consumers out there, not knowing what to do by it.

BUSER: Well, as someone that got burned by it, my advice would be, stop taking it. That can hurt you.

ZAHN: Joseph Buser, Robert Sullivan, thank you for your time.

SULLIVAN: Thank you. Thank you.

BUSER: Thank you.

ZAHN: As we've seen tonight, prescription drugs are a multibillion-dollar business. They are marked as aggressively as cars, soft drinks or soap, all to increase sales. But now there are some allegations that some of the giant pharmaceutical companies have used marketing techniques that are less than honest.

Drew Griffin has that part of the story.

(BEGIN VIDEOTAPE)

DREW GRIFFIN, CNN CORRESPONDENT (voice-over): When Schering- Plough wanted to increase sales of its hepatitis drug, Intron A, it set up clinical trials and pitched the drug physicians. DR. Chris Pappas says Schering-Plough offered to pay him for every new patient he placed on the trial.

CHRIS PAPPAS, ST. LUKE'S EPISCOPAL HOSPITAL: It was somewhere around $1,500 to $2,500 per patient.

GRIFFIN: The problem, doctors say those clinical trials may not have been trials at all, but sales incentives. The company acknowledges the firm's sales practices are under investigation.

When Warner-Lambert wanted to boost sales of its epilepsy drug Neurontin, sales reps told doctors the drug could be prescribed for a lot more ailments than just seizures.

DAVID FRANKLIN, INDUSTRY WHISTLE-BLOWER: The company made a very conscious decision to expand what we would actually the drug to, to about 15 to 20 other indications, other syndromes, illnesses that we had absolutely no evidence that it was actually effective for.

GRIFFIN: Warner-Lambert's promotion of Neurontin for nonapproved use was, according to David Franklin, sales rep turned industry whistle-blower, strictly a decision to boost sales.

FRANKLIN: The company's own documents said that was about a $400 million a year market, which simply wasn't enough. It didn't justify the R&D, the sales and promotion for that particular product.

GRIFFIN: Far beyond free tickets to ball games, golf outings and expensive dinners, the investigations into some of the biggest drug companies have uncovered outright payoffs made directly to doctors to write prescriptions.

Mike Sullivan is the U.S. attorney in Boston.

MIKE SULLIVAN, U.S. ATTORNEY: I think most patients would be horrified to think that somehow their physician's judgment could be affected or was affected based on lavish gifts, lavish trips, stipends or based on some false information provided to the pharmaceutical industry.

GRIFFIN: False information? That is exactly what Sullivan's prosecutors exposed when it went after Warner-Lambert. Last may, Pfizer, which now owns Warner-Lambert, pleaded guilty to the off-label promotion of Neurontin and paid a $430 million fine.

In a statement, Pfizer says it is committed to compliance with all health care laws and FDA requirements and to high ethical standards in all aspects of its business practices. As a whistle- blower, David Franklin, the former Warner-Lambert sales rep, will receive $26 million of the fine for his help in the case, a financial victory, but Franklin was hoping for much more.

FRANKLIN: Real change, real congratulations would be in order when docs can start trusting the information that they're getting.

GRIFFIN: DR. Chris Pappas is one of those doctors who no longer trusts the information drug companies bring to his office, and he says with good reason.

PAPPAS: What this essentially was, was a marketing activity in the guise of a clinical trial.

GRIFFIN: Dr. Pappas heads the clinical trial unit at St. Luke's Texas Liver Institute in Houston. When a sales rep asking him to take part in a clinical trial for the drug Intron A, he said no. Doctors, he says, were to be paid for their time, time to fill out paperwork, report their findings and prove or disprove the effectiveness of the drug.

But Dr. Pappas says there was little paperwork, just the promise of a stream of checks for every new patient added to the so-called trial.

PAPPAS: You know, $25,000 to maybe $50,000.

GRIFFIN (on camera): To the doctor?

PAPPAS: To the doctor. GRIFFIN (voice-over): Fifty thousand dollars for the doctor, hundreds of thousands of dollars to the company on a clinical trial that Dr. Pappas says, if conducted as pitched, was scientifically worthless.

PAPPAS: Well, nobody would admit that it was to prescribe the drug. That's essentially what happened.

GRIFFIN: Schering-Plough would not discuss the clinical trial, but told CNN it will implement new standards of business conduct for this fall.

"Our focus today," the company says, "is on the benefit to the patient, not to the benefit of the physician and that is how we're training our reps."

But Dr. Pappas says it is not just the drug companies that are to blame.

PAPPAS: I think the medical community has not been very responsible in accepting their part of the responsibility for all of this.

GRIFFIN: And now that may be changing. St. Luke's Hospital has begun seminars and instituted guidelines for doctors about gifts and payments from the drug companies. Other institutions like Duke University Medical Center in North Carolina have banned all drug company freebies, from coffee mugs to lunches, and limited when sales reps can see physicians.

But according to the chairman of Duke's Pharmacy Committee, doctors remain dependent on the drug companies and their sales staff.

DR. PETER KUSSIN, DUKE UNIVERSITY: That's absolutely true. And I think unfortunately, when this is looked at, the pharmaceutical industry is the major source of information about new medications and new treatments.

GRIFFIN: U.S. attorney Mike Sullivan says his prosecutions have netted $2.2 billion in fines. And that, he says, should be a wakeup call to the industry.

MIKE SULLIVAN, U.S. ATTORNEY: The message I think is clear to the pharmaceutical industry, you know, that corrupt practices, illegal practices, practices that violate rules, regulations, or loss is not tolerated for this administration and this department.

GRIFFIN (on camera): But David Franklin isn't so optimistic. The prosecutions and settlements here in Boston, even those costing $430 million, are, to the huge pharmaceuticals, just a drop in the bucket.

FRANKLIN: I'm sure there are lots of high-fives, and slapped pats on the back at Pfizer when they settled this for $430 million. It was a stunning success.

(END VIDEOTAPE)

ZAHN: Our Drew Griffin reporting from Boston.

The drug Nerontin could earn Pfizer $2 billion in sales this year alone. Since it came on the market in 1994, almost 10 million prescriptions have been written for it. And one footnote, CNN asked PHARMA, the pharmaceutical industry trade association, to comment on the story. A spokesman declined comment citing antitrust issues.

Ahead on our CNN security watch, the end of a long battle as President Bush signs the intelligence reform bill into law. The feeling of some 9/11 family members when we come back.

(COMMERCIAL BREAK)

ZAHN: It is certainly controversial, its is also comprehensive, and now it happens to be the law. In tonight's CNN Security Watch, President Bush signs the 9/11 intelligence reform bill. It creates the powerful new post of a national intelligence director who will report to the president and oversee 15 separate intelligence agencies making sure they share information.

(BEGIN VIDEO CLIP)

GEORGE W. BUSH, PRESIDENT OF THE UNITED STATES: The many reforms to this act have a single goal: to insure that the people in government responsible for defending America have the best possible information to make the best possible decisions. The men and women of our intelligence community give America their very best every day. And in return, we owe them our full support.

(END VIDEO CLIP)

ZAHN: The law is the largest overhaul to the intelligence system in more than a half century. The 9/11 families have mixed feelings about it.

I'm joined by Monica Gabrielle who lost her husband at the World Trade Center. She supports the law. Debora Burlingame lost her brother Charles who was the captain of the plane that crashed into the Pentagon. She opposes it.

Good to see both of you.

Monica, I know this has been a long road for all the families. What went through your mind when you saw the president sign this bill?

MONICA GABRIELLE, LOST HUSBAND ON 9/11: I think it was bittersweet. Certainly we're thankful that something has been passed after three long years. Yet, you know, a little bitter, because it took the families to push to have anything done for three years. So it was bittersweet.

And let me just say that this is far from the end. This is far from a perfect bill. It certainly leaves a lot that hasn't been addressed, including congressional oversight, including the need for a civil liberties board that is going to truly monitor our liberties as some of these things are enacted. And we have to be very careful about going forward as these things are beginning to be implemented.

We have to continue to be the watchdog. Certainly, the immigration issues that Deborah's been fighting for need to be addressed in the next Congress.

ZAHN: So, Deborah, basically what Monica's saying is a less than perfect bill is better than nothing. Will you concede that?

DEBORA BURLINGAME, LOST BROTHER ON 9/11: Well, going into the fight for a better bill, we felt, my group of 9/11 Families for Secure America, 300 victims' families, felt that this was going to be the 9/11 bill. The momentum was behind this bill, and if we didn't get the immigration stuff in there, it wasn't going to get in.

And now we have President Bush has come forward and said, you know, he's committed to serious immigration reform in the 109th Congress, and we're going to take him at his word. This bill, unfortunately, I fear, that it's going to give a false sense of security to the American people, because frankly some of the 9/11 families, and certainly Senators Lieberman and Collins, billed this as the thing that's going to save us from terror if it's not done in the next ten minutes. And we know perfectly well it's only half a bill, because it leaves a wide open door.

ZAHN But while you think it's a half a bill, you don't think it makes Americans at all safer?

BURLINGAME: I think it makes Americans maybe feel safer. But as long as we have, say, 14,000 illegal aliens who are coming from the Middle East, from countries like Pakistan, Sudan, Saudi Arabia, Syria, they're coming -- some of them undocumented. They're not coming on airplanes with passports and visas, they're literally walking over our borders, hidden among the thousands and thousands of teaming illegal and undocumented aliens getting into this country every day.

ZAHN: But Monica, that is your expectation down the road to be addressed? You're frustrated by that as well?

GABRIELLE: It's certainly not perfect. However, what this bill does do is calls for the strengthening of our visa requirements. The 19 terrorists that attacked us on September 11 didn't need the driver's licenses, they had visas, fraudulent visas.

But, you know, what we need to do is strengthen the visa requirement. We need to educate our border control people, our passport people to stop these people from getting in with fraudulent documents.

And, you know, the -- there are a lot of things that still need to be done in the 109th Congress. And we look forward to seeing Debra down there.

ZAHN: Fighting away. The final thought from you, about whether you're optimistic that these things will be directly dealt with, and dealt with in a comprehensive way.

BURLINGAME: I want to correct Monica on one thing first, and that is, if they didn't need these driver's licenses, why did they have 63 of them. They used 364 aliases. We'll never know all the driver's licenses they used. And they got in states where they didn't have to prove they were here legally. If HR-10 had passed, they couldn't have used the fraudulent visas to get driver's licenses, they would have expired. And they did use them to get on those airplanes.

GABRIELLE: But they shouldn't have been here with the fraudulent visas to begin with. So the driver's licenses are irrelevant

BURLINGAME: The Senate bill won't change that at all. And that's why we're unhappy with it. But in a way, the fact that the immigration stuff didn't get in the bill might be good, because maybe now we'll have a real conversation about a problem that's been going on for 30 years.

ZAHN; I think it will be more than just a conversation. Debra Burlingame, Monica Gabrielle thank you. My heart goes out to you. It must be so tough to debate this stuff among your family members.

Remember here at CNN we always have the latest stories about your safety and security.

Time to check in with my colleague, Miles O'Brien right now, who's actually headed north. He joins us from New York City tonight. He's anchoring "NEWSNIGHT" tonight for Aaron.

What's up, Miles?

MILES O'BRIEN, CO-HOST, "LIVE FROM": It's good to be here. Thank you very much, Paula.

We're going to talk to James L. Brooks tonight, the great writer and moviemaker, "Terms of Endearment," "Broadcast News," out with a new movie called "Spanglish." Already a lot of Oscar buzz about it.

And then also Lowell Bergman the famous documentarian and producer who is out with a documentary which might make you a little paranoid, Paula. He tracks down people who try to get a hold of your privacy and peek in.

For example, people who listen to baby monitors to try to find out what's going on. And is there any privacy left in this world? That's a question we might ask tonight.

ZAHN: Oh, boy. Can you imagine if anybody listened to the baby monitors in your house and my house? Sleep deprived parents. They are not pretty conversations are they?

O'BRIEN: They would not enjoy the conversation. I don't know how much they'd learn about our house.

ZAHN: Well, exactly. They'd just learn you're very tired when you have a newborn at home. O'BRIEN: Yes.

ZAHN: Miles, thanks so much. See you at 10.

Well, he is back in court. Will those stories about Michael Jackson's sex life be used against him in his upcoming trial?

(COMMERCIAL BREAK)

ZAHN: A rare public appearance by Michael Jackson under that umbrella. The pop star opened the amusement park at his Neverland Ranch to about 200 children. He wished them all a merry Christmas.

And whether it was meant that way or not, it's certainly a nice P.R. gesture, because on Monday, pretrial hearings resume in Jackson's child molestation case.

Prosecutors will try to have allegations of previous sexual abuse admitted as evidence, believing it will show a pattern of behavior. In 1993, Jackson was accused of sexually abusing two children. Charges were never filed.

One of those alleged victims was a 13-year-old boy whose uncle, Raymond Chandler, has written a book about it, "All That Glitters: The Crime and the Cover-up." I'm joined by Raymond Chandler, who also happens to be an attorney.

Good to see you. Welcome.

RAYMOND CHANDLER, ATTORNEY/AUTHOR: Thank you, Paula.

ZAHN: So, what do you think the similarities are between the current charges and what is alleged to have happened with your nephew in 1993?

CHANDLER: Well, I think there are several. One that you're likely to see is the use of Neverland as a lure to bring children in and trap them into a relationship, an illicit relationship, much like a spider uses a web to trap a fly. I'm sure that we're going to see that brought up in the trial.

Another similarity would be just the number of times Mr. Jackson is sleeping alone in bed with these children. He likes us to believe that these impromptu events that occur at Neverland where kids mob his bedroom and they just don't want to leave.

But in fact, in my nephew's case, he slept alone with Mr. Jackson over 50, maybe 60 nights in various locations around the world, not just Neverland.

ZAHN: Why weren't formal charges ever filed in that case?

CHANDLER: Well, the formal charges weren't filed -- five months after my nephew's civil suit was settled, the district attorney finally got around to asking my family to testify. They requested he be placed in a witness protection program because of the death threats and bomb threats and other things that were happening to them. That request was denied, and they elected not to testify because they simply feared for their security.

ZAHN: Do you understand why some people listening tonight will say, well, that listens the credibility of what this young man had to say, because he ended up settling out of court, and how do we know his charges are true?

CHANDLER: Well, obviously people are going to say that. But I think people need to remember that there was no charges during the civil trial. The civil trial was settled in January of '94. The district attorney didn't even get around to asking the family to testify until May of '94. So the civil trial was over at that point.

ZAHN: "Vanity Fair" reports that prosecutors have asked your nephew to testify at this new trial. Will he?

CHANDLER: I don't know, Paula. That's a tightly kept secret. I certainly hope he does.

ZAHN: Have you been asked to testify?

CHANDLER: I'm not permitted to answer that question.

ZAHN: And what can I read into that question? Is that a firm no? Or yes, a possibility?

CHANDLER: Paula, you know, I wish I could say more. I'm an officer of the court. And I'm simply not permitted by law to answer that question.

ZAHN: And in all fairness to Michael Jackson here, he has denied all of these allegations in a news conference he set up. How could you prove on your nephew's behalf everything you just said happened between Michael Jackson and him?

CHANDLER: Well, I think the best way -- it would be difficult to prove that here in the time we have. If someone were to read my book, I laid out the evidence. It's very strong. It's not just opinion evidence. It's documents, depositions, letters. There was a lot of evidence in 1993.

And I think if someone were to read that, everyone who has read the book, even skeptics have said to me they're convinced after reading it.

ZAHN: Raymond Chandler, we'll be watching you to see whether you end up getting called or not, since you say you can't answer that question. Thank you for joining us tonight.

CHANDLER: Thank you, Paula.

ZAHN: Appreciate your time. Question, if an Austrian movie star can run for governor of California and win, why shouldn't a Jewish country singer run for governor of Texas? Kinky Friedman, next big challenge, just ahead.

(COMMERCIAL BREAK)

ZAHN: Kinky Friedman guaranteed himself a place in music history as the singing Jewish cowboy. He moved on to writing mystery novels and hobnobbing with movie stars and presidents. Well, now it looks like he's on the verge of a new career.

Here's our Bruce Burkhardt.

(BEGIN VIDEOTAPE)

(MUSIC)

BRUCE BURKHARDT, CNN CORRESPONDENT (voice-over): Is it possible, is it just possible that we may be looking at the next governor of the great state of Texas.

ARNOLD GARCIA, "AUSTIN AMERICAN STATESMAN": Well, you know, Texas elected a country singer to the governorship in the 1940s. It's not -- it's not unprecedented that this could happen.

(MUSIC)

BURKHARDT: You can't get much more politically incorrect than Kinky Friedman. He's been that way since he pioneered the Jewish country music genre with his band, Kinky Friedman and the Texas Jewboys.

KINKY FRIEDMAN, TEXAS GUBERNATORIAL CANDIDATE: I'm a bastard child of twin cultures, Texas and Jewish. And the only thing they have in common is we both like to wear our hats indoors.

(MUSIC)

BURKHARDT: Blending Kinky's gift for satire with a genuine love of country music, songs like "They Ain't Making Jews like Jesus Anymore" and "Ride 'em, Jewboy," Kinky had a cult following that never really hit it big.

So in the mid-'80s, he turned to something else: writing mystery novels with himself, the Kinkster, as a private eye.

FRIEDMAN: I think there's 18 novels that I've churned out. I mean, carefully crafted.

BURKHARDT: A talented writers, he counts both Bill Clinton and George W. Bush among his fans. Both have had him as a guest at the White House. Maybe that's what gave him a taste for politics.

FRIEDMAN: People are so fed up with career politicians lying to them. And also, if Willie and Lance Armstrong stay out of the race, I think you're talking to the next governor of Texas. BURKHARDT: The election is not until 2006. But running as an independent, Kinky is wasting no time.

FRIEDMAN: Well, here's my campaign posters. How hard could it be? My friend Bobby, big ole guy, he came over and said, "These ones with the little Jew star are real popular."

BURKHARDT: But what started as kind as a joke has turned into something a bit more serious. Think California.

(on camera) You do think you have a shot?

FRIEDMAN: Well, I'm not running to lose. I think Arnold has opened the door to a lot of things here in Texas.

Now we're going to the Rescue Ranch, one of my favorite places.

BURKHARDT (voice-over): One thing Kinky doesn't joke about is animals. He loves his animals.

FRIEDMAN: There's Bill Clinton and Monica Lewinsky, right?

BURKHARDT: Adjacent to Kinky's ranch here in the Texas hill country is his Utopia Rescue Ranch for stray dogs. If he were governor, he'd make Texas a no-kill state, no euthanizing unwanted dogs. And under a Friedman administration, declawing cats would be illegal.

FRIEDMAN: Special place in hell for anybody who declaws a cat.

BURKHARDT: As for other issues his positions are a little hazier. Take abortion.

FRIEDMAN: And I'm not pro-life and I'm not pro-choice. I'm pro football.

BURKHARDT (on camera): Now, that's evasive, man. That's evasive.

FRIEDMAN: I'll tell you what, let's write that chapter of Texas history together.

BURKHARDT: Oh, good. That's good.

(voice-over) Kinky is counting on the support of friends like legendary country songwriter Billy Joe Shaver, whose birthday party in Austin was a rare occasion for Kinky to perform.

BILLY JOE SHAVER, SINGER: I don't think there's any experience problem, because Kinky's been a politician all his life.

BURKHARDT: Also on hand, another potential supporters, Robert Duvall.

ROBERT DUVALL, ACTOR: Don't turn your back on him -- don't turn your back on him when you've got your woman around. BURKHARDT: OK. So some of his support is lukewarm.

Still, Kinky believes it's a job he can get. And it's a job he can do.

FRIEDMAN: First of all, this job is a notoriously easy gig. The governor of Texas requires no heavy lifting. The lieutenant governor does all the heavy lifting. But the governor should do some spiritual lifting. That's where I come in.

BURKHARDT: It's a long ways off, 2006. In the meantime, Kinky has picked up a couple of tips from Teresa Heinz Kerry about dealing with the media.

FRIEDMAN: You know what I have to say to that. Shove it!

(END VIDEOTAPE)

ZAHN: We've heard that before, Bruce Burkhardt. An update on Kinky Friedman. We hear he plans to formally announce his candidacy early next year. And I guess he's going to have to figure out where he's going to be able to smoke that cigar legally if he actually does it.

Well, those late-night laughs are just ahead. Please stay with us.

(COMMERCIAL BREAK)

ZAHN: Today the Bush administration predicted the economy will grow by 3.5 percent next year. Well, last night the economic outlook was on the mind of "The Daily Show's" Jon Stewart.

(BEGIN VIDEO CLIP)

JON STEWART, HOST, "THE DAILY SHOW": Turning now to the economy, with the dollar hitting new lows and job growth continuing to proceed very slowly, the administration gathered officials, economists and business leaders for a two-day economic summit. It was a time for honest reflection, and sober appraisal.

We do? I feel so stupid.

And who's going to address the fact that we have a historic trade deficit, a plummeting dollar and building resentment against not only Americans but American goods around the world, Treasury Secretary Snow. Well, then I guess there's no problem there.

(END VIDEO CLIP)

ZAHN: On to now the results of tonight's question of the day. As we say every night, it's not scientific, just a sampling of those of you that logged on.

Thanks so much for joining us as we wrap up the week here. We'll be back same time, same place next week. Have a great weekend. "LARRY KING LIVE" is next.

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


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