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CNN Newsnight Aaron Brown
FDA Scientist Says Drug Testing System is Broken; Rhode Island Journalist Held in Contempt of Court
Aired November 18, 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, CNN ANCHOR: Good evening again.
The center of the program tonight deals with an issue that touches every one of you no matter your age, your gender, your politics, your station in life. Are the medicines you take, or at least the risks of those medicines because all medicines have some risks, are they known and understood? Are drug companies in their search for both cures and profits allowed to hide the dangers of drugs? Is the FDA too cozy with those it's supposed to regulate?
None of these questions has an easy answer but there are some clues tonight, some hints. "The Washington Post" reported today that over the last four years, the FDA has been less aggressive in policing drugs than it used to be.
From recalls to warning letters, there has been a dramatic decrease in regulation and that, according to "The Post," even as evidence of adverse affects from new drugs has been rising dramatically, enforcement has slackened. So, tonight we'll take a look at the process and the politics and wonder has the balance shifted away from safety toward something else?
The whip begins with CNN's Chris Huntington, Chris start us off with a headline.
CHRIS HUNTINGTON, CNN CORRESPONDENT: Aaron, there's a new whistle-blower in Washington. FDA scientist David Graham says the nation's drug safety program is broken and that his bosses at the FDA tried to keep him from reporting that Vioxx may have caused 100,000 heart attacks -- Aaron.
BROWN: Chris, thank you. We'll get to you at the top tonight.
Next to Falluja and a discovery there, CNN's Jane Arraf is still in the city with the Army's 1st Infantry, Jane a headline tonight.
JANE ARRAF, CNN BAGHDAD BUREAU CHIEF: Aaron, American troops looking behind doors in Falluja's abandoned southeast are making some chilling finds.
BROWN: Jane, thank you.
And finally another skirmish in the battle between the government and reporters wanting to keep their sources secret, CNN's Deborah Feyerick with that for us, Deb a headline. DEBORAH FEYERICK, CNN CORRESPONDENT: Aaron, a journalist possibly heading to prison after a federal judge finds the reporter guilty of criminal contempt for refusing to reveal the identity of the source -- Aaron.
BROWN: Deb, thank you. We'll get back to you and the rest shortly.
Also on the program tonight, Massachusetts and gay marriage, a year and a presidential election later, where do things stand?
Also tonight, at a high school on Long Island a reminder of the price of war, the war in Iraq and Afghanistan, three students who volunteered, three students remembered.
And morning papers, the rooster, the wind chimes, the weather and all wrap up the hour, lots to do in the hour ahead.
We begin tonight with Vioxx, a little yellow pill that, along with others like it, was supposed to revolutionize the treatment of long term pain, which made it a golden pill worth billions of dollars to Merck, the manufacturer.
Then reports of fatal side effects started coming out. The company pulled the drug but said it had done no wrong. The FDA said likewise. Today, questions from Congress began.
We cover the story from a number of angles tonight, beginning first with CNN's Chris Huntington.
(BEGIN VIDEOTAPE)
HUNTINGTON (voice-over): FDA scientist David Graham testified that he estimates Vioxx caused more than 100,000 heart attacks, 30 to 40 percent of them fatal but Graham told members of the Senate Finance Committee that his FDA superiors ridiculed him and insisted on changes.
DR. DAVID GRAHAM, ASSOCIATE DIRECTOR FOR SCIENCE FDA: When I was pressured to change my conclusions and recommendations. One drug safety manager recommended that I should be barred from presenting the poster at the meeting and also noted that Merck needed to know our study results.
HUNTINGTON: Graham offered a blistering condemnation of the FDA's drug safety program saying that the system is broken and often overlooks the dangers of drug side effects.
GRAHAM: The FDA as currently configured is incapable of protecting America against another Vioxx.
HUNTINGTON: A senior FDA official responsible for evaluating new drugs flatly dismissed Graham's assessment and rejected his contention that several drugs still on the market, including Bextra, a Cox-II inhibitor from Pfizer, are dangerous and should be recalled.
UNIDENTIFIED MALE: Do you agree with Dr. Graham that five drugs he mentioned pose a significant safety risk to Americans?
UNIDENTIFIED FEMALE: No, I do not.
HUNTINGTON: Testifying via satellite, a former Merck consultant told lawmakers that the company refused his request for data on Vioxx related heart attacks. And, another doctor disputed Merck's central points that heart attacks occurred only in those who took the drug for more than 18 months.
UNIDENTIFIED MALE: Merck lacked information to know when the risk occurred and you cannot say with confidence given the available data.
HUNTINGTON: Merck Chairman and CEO Ray Gilmartin presented a well honed defense of his company and Vioxx insisting that the first time Merck saw clinical evidence of heart attacks linked to Vioxx was just a week before the drug was pulled from the market in late September.
DR. RAYMOND GILMARTIN, CHAIRMAN, PRESIDENT AND CEO, MERCK: Merck believed wholeheartedly in Vioxx. I believed wholeheartedly in Vioxx. In fact, my wife was taking Vioxx, using Vioxx up until the day we withdrew it from the market.
(END VIDEOTAPE)
HUNTINGTON: Now, Gilmartin added that David Graham's estimate of Vioxx-related heart attacks played no role in Merck's decision to pull Vioxx off the market but it was clear from the committee members' reaction that Graham's testimony may well be a catalyst for overhauling the FDA's drug program -- Aaron.
BROWN: We have a long way to go on this tonight. Let me just start with one question. It's not factually correct to say, this is the question, that there was no evidence of a cardiovascular problem with Vioxx before this spring, correct?
HUNTINGTON: Correct. There was -- what Merck is holding to is clinical data. Now, I'm going to get bogged down, I could get bogged down in the medical difference between an epidemiological study and a clinical study but that's where Merck wants to draw the defense line.
There was plenty of evidence, in fact, even some early speculative evidence that Merck was well aware of back in 1996. That was a document, in fact, that came out in the hearing today.
So, plenty of talk in the medical community about the cardiovascular dangers of Vioxx but as far as Merck is concerned, there was no clinical data that drew the link between the drug and heart failure until this study that they are, you know, showing up in late September the reason that they cite for taking the drug off the market.
BROWN: Chris, thank you. You danced around that epidemiological question pretty well. The difference in a sentence basically is clinical means this heart attack was caused by this drug, as opposed to a body of statistics which seems to suggest that heart attacks were caused by the drug. Keep that in mind because it's going to come up a fair amount tonight. We have a lot of questions to ask on this.
Later in the program we'll talk with Senator Grassley of Iowa, who chaired the hearings today. A panel of experts join us as well.
We want to deal with some of the other news of the day first and that begins in Falluja and more reminders of not just the price but also the uncertain nature of the victory.
The cost in American casualties for the battle of Falluja now stands at 51 dead, 425 wounded. The uncertainty lies in holding the city and especially in dealing with the insurgents who scattered to other parts of the country, a reminder of that problem in particular could be found in a house on a street in Falluja today.
So, from Falluja tonight, here's CNN's Jane Arraf.
(BEGIN VIDEOTAPE)
ARRAF (voice-over): The gunmen inside the house and in underground bunkers fought ferociously and died violently.
LT. COL. PETE NEWELL, U.S. ARMY 1ST INFANTRY DIVISION: This one open area is where we hit probably the stiffest resistance of the four days we really spent clearing house-to-house and block-to-block.
ARRAF: Outside the houses were fighting positions and explosives. Inside were some clues as to why they fought so hard. This Iraqi commander says two men, whose names are written next to this al Qaeda mural were believed to be the top lieutenants of Abu Musab al-Zarqawi in this sector.
UNIDENTIFIED MALE (through translator): What we found here is al Qaeda's operation in Falluja. This is where the operations were orchestrated from. This is very important. This is the base where they moved from, where they organized their resistance, where they operated from.
ARRAF: He says he read a letter signed by Zarqawi who describes himself as their little brother, asking for an update on their operations and their fighters. He tells us another letter from one of the men, who calls himself Abu Moussa Mushami al-Lugnani (ph) asks Zarqawi for funds and fighters.
In this modest house was a computer with the hard drive removed. Throughout, clothing was scattered on the floor, even food and personal photos. There were also more sinister finds.
(on camera): This building was also part of the complex apparently. In this back room they found a pile of landmines and antitank mines. Some of them had the explosives removed. That's the way that they commonly make homemade bombs. Also here lying on the floor are what's left of surgical supplies, sutures and band-aids.
(voice-over): A third of a mile away in Falluja's deserted industrial section, Alpha Company troops made more chilling discoveries what appeared to be a repair shop for antiaircraft guns and a makeshift classroom.
CAPTAIN DOUG WALTER, U.S. ARMY 1ST INFANTRY DIVISION: On the board itself they had sketches of the -- of aircraft and F-16, F-18 in parenthesis, apparently some kind of training room on how to shoot down U.S. aircraft. And then in the rest of the building antiaircraft weapons in various stages of disrepair. We think this was like a maintenance shop.
ARRAF: Close by an apparent car bomb factory. On this work table were pieces of shrapnel and bomb making materials. This vehicle registered in Texas had parts of it ripped out presumably to pass with explosives, soldiers say. A few feet away were enough bags of sodium nitrate and ammonium nitrate to kill dozens. More doors opened into the hidden terror of this city.
(END VIDEOTAPE)
ARRAF: And these weren't entirely unique. This entire section, Aaron, is dotted with what could be factories to make car bombs or what could be weapons depots and that is just one section of the city -- Aaron.
BROWN: We didn't really see a wide shot. Was this a house standing alone? Is it in the middle of a neighborhood and, if it's in the middle of a neighborhood, is it even conceivable that people who lived around there didn't know what was going on there?
ARRAF: You know that was the interesting thing about this neighborhood, about this sector. The civilians had been driven out weeks, if not months ago and essentially what the troops found when they rolled in here was an entire section of the city, the eastern side, where they had taken over. The insurgents had taken over the neighborhood, expelled the civilians. They took over the houses and they fortified them -- Aaron.
BROWN: Jane, thank you, Jane Arraf in Falluja again for us tonight.
Today, the commander of the Marine division that battled its way into Falluja said the insurgency's back has been broken. Also today, "The New York Times" reported that the general's own intelligence officers have prepared a written assessment of the situation that is a whole lot less optimistic.
If troop levels are reduced in Falluja, they warn, the insurgents will bounce back there. The Iraqi troops are not yet ready to defend the city. Their bosses in Washington and in Baghdad disagree with the conclusions on the ground and decides there is plenty of evidence those troops are needed elsewhere in the country as well.
With that part of the story tonight, CNN's Karl Penhaul.
(BEGIN VIDEOTAPE) KARL PENHAUL, CNN CORRESPONDENT (voice-over): Homes lie in ruins. Unidentified corpses rot under Falluja's rubble. The Iraqi government says it's victory.
THAIR AL NAKIB, IRAQI PM SPOKESMAN (through translator): Falluja is no longer a stronghold or a haven for the terrorists. That battle has been won and we need only a few days to liquidate all the terrorists.
PENHAUL: That may be easier said than done. U.S. commanders say some insurgents escaped Falluja. It's not clear how many. Rebel violence has spiked in other cities.
During Wednesday night and Thursday, insurgents battle security forces in Ramadi. In Baghdad, a car bomb exploded outside a police station killing and wounding civilians. And, in Mosul, the provincial governor's office was mortared. The Iraqi government seemed un- phased. Thursday morning, insurgent gunmen could still be seen freely roaming the streets.
In the city of Falluja, the Iraqi government says it's offering food and $100 subsidy to each family, the prime minister sending deputies to the city this weekend to assess damage and plan reconstruction.
As yet there's no accurate independent assessment of the civilian casualty toll. Marines halted an offensive there in April, partly because of a political backlash against civilian casualties.
The U.S. military says it's not responsible for counting this time, referring all queries to the Iraqi government, which last week said only 14 civilians had been injured. Judging by al-Nakib's response...
AL NAKIB: I'm not going to get into numbers, sorry.
PENHAUL: ...the Iraqi government seems to be tired of answering questions about the human cost of its victory in Falluja.
Karl Penhaul, CNN, Baghdad.
(END VIDEOTAPE)
BROWN: The decision to take this country to war is a decision known to just a handful of men alive today. Only a president can make that decision. And, in that regard presidents, current and former, share a unique bond that even in our divided land transcends politics.
Today in Little Rock, four presidents, one building, different politics, common bond, the opening of the Clinton Library reported for us by CNN's Candy Crowley.
(BEGIN VIDEOTAPE)
CANDY CROWLEY, CNN SR. POLITICAL CORRESPONDENT (voice-over): The weather was completely miserable, wet, cold and windy but how many times can you see Bono and four U.S. presidents in the same place?
JIMMY CARTER, FORMER PRESIDENT OF THE UNITED STATES: But at the end of a very difficult political year, more difficult for some of us than others, it is valuable for the world to see two Democrats and two Republicans assembled together all honoring the great nation that has permitted us to serve.
CROWLEY: It was like a meeting of the world's most elite, most unlikely club, gathered to vet one of its own, part high ceremony, part rotary club.
GEORGE W. BUSH, PRESIDENT OF THE UNITED STATES: A fellow in Saline County was asked by his son why he liked Governor Clinton so much. He said, "Son, he'll look you in the eye. He'll shake your hand. He'll hold your baby. He'll pet your dog all at the same time."
GEORGE H.W. BUSH, FORMER PRESIDENT OF THE UNITED STATES: Simply put, he was a natural and he made it look too easy and, oh, how I hated him for that.
CROWLEY: The natural, looking pale and smaller since heart surgery, is still the master politician, sweetened now by the touch of an elder statesman.
BILL CLINTON, FORMER PRESIDENT OF THE UNITED STATES: I once said to a friend of mine about three days before the election and I heard all these terrible things, I said "You know, am I the only person in the entire United States of America who likes both George W. Bush and John Kerry, who believes they're both good people who believe they both love our country and they just see the world differently?"
CROWLEY: He has put together the biggest, most expensive presidential library yet, filled with more objects, more paperwork than any previous administration. It is so very Bill Clinton.
SEN. HILLARY CLINTON (D), NEW YORK: The building is like my husband. It's open. It's expansive. It's welcoming. It's filled with life.
CROWLEY: Candy Crowley, CNN, Little Rock.
(END VIDEOTAPE)
BROWN: Ahead on the program tonight another reporter sent to jail for refusing to name a source.
And a high school has a lot to be proud of but also the tears to show for it, students who answered the call to war, a break first.
From New York this is NEWSNIGHT.
(COMMERCIAL BREAK)
BROWN: More now on the Vioxx problem. Some would argue that it's not just a Vioxx problem, the FDA problem more like it because of the relationship the FDA has now with pharmaceutical companies.
About a dozen years ago at the height of the AIDS epidemic, the FDA came under fire for being too tough on drug companies, too slow. Congress stepped in and has since allowed the companies to help pay the FDA staff. As a consequence, fewer drugs have been forced off the market and some congressional leaders say that now must change.
(BEGIN VIDEO CLIP)
SEN. CHARLES GRASSLEY (R), IOWA: One of my concerns is that the FDA has a relationship with drug companies that is far too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be FDA's first and only concern.
(END VIDEO CLIP)
BROWN: Senator Grassley made those statements at the hearings today, hearings he chaired and he joins us now from Washington. He's the chairman of the Senate Finance Committee, a Republican from Iowa, and it's good to see you sir.
You suggested today that maybe there needs to be an independent panel that reviews the work the FDA does. Isn't that what the FDA is supposed to do in the first place?
GRASSLEY: Yes. There is specifically an Office of Drug Safety that is connected with the Office of New Drugs and there's a relationship between those organizations before a drug gets on the market.
So then, the Office of Drug Safety then finds out later on that there's something wrong, then that makes the Office of New Drugs look bad. So, I think that we need to separate, well just completely separate and make independent the Office of Drug Safety.
BROWN: Let me ask, it's the only really political question I'm going to ask tonight but it's sort of a delicate one, to what extent do you think it's possible that the whole anti-regulatory belief structure of your party has contributed to the situation we find ourselves in?
GRASSLEY: Well, I don't hesitate to answer that because you asked a political question and it involves my party. The problem is I just don't know. You know there's always accusations but I consider some demagoguery connected with it when there's an accusation just because you take campaign contributions or because you're a big corporation that you're necessarily affiliated with the Republican Party.
I'm a Republican all my life, a conservative Republican, a supporter of the president and I even take campaign contributions from pharmaceutical companies and probably have even taken from Merck. You know, I don't keep track of everything I get but it hasn't stopped me from taking them on.
BROWN: No, it certainly has not and that's really not -- I'm just wondering if -- and it's not really just Republicans. I mean some famous Democrat once said the era of big government is over. If we're in a time when we want less regulation, don't we -- might we not find ourselves in situations where we are paying the price for too little regulation?
GRASSLEY: Well, the argument is very appropriate for where we are now because maybe ten years ago the public policy debate was how long it was taking to get a miracle drug onto the market and how many people were dying because the miracle drug wasn't available? And now here we are beating the same organization over the head because they aren't enough concerned about safety.
I can pass a law. It calls for efficacy of a drug. It calls for safety of a drug. Those are 40-year-old laws. You know you can write a law but you've got to account to the administrators to carry it out according to our spirit. All I can do is make sure that I do my constitutional job of oversight.
BROWN: David Graham today talked about five drugs, one dealing with anti-cholesterol, asthma, weight loss, pain, just something for everybody pretty much in your medicine cabinet that he felt still -- drugs still out there and still dangerous and the FDA said, "No, everything's fine. Don't worry." Do you believe everything's fine, don't worry?
GRASSLEY: I think I got a lot of confidence in the doctor. Here's the thing though that concerns me, not just what he said today but just this year we had two instances of one with the antidepressant and its effect on suicide by children and we had a scientist earlier this year say that there was a great deal of concern about it. He was suppressed. Eventually he won out and there's a warning on there now.
Now we have this situation with Dr. Graham and Vioxx and there's too much effort to not let the scientific process work within FDA. I think the scientific process by which one scientist discovers something and it has to be reviewed, a peer review by other scientists, is just about as non-political as you can get but when that process is suppressed by the agency, then the public safety is not being protected the way it should be protected.
BROWN: Senator, it's always good to see you. Thanks for your work today.
GRASSLEY: You bet, Aaron.
BROWN: This is a great and important issue.
Still to come, how the FDA approves drugs, including Vioxx, followed by a discussion on whether that procedure needs to change in the wake of what we now know, a break first.
Around the world this is NEWSNIGHT.
(COMMERCIAL BREAK)
BROWN: Vioxx is both a medical story and a process story and process stories can be a bit wonky. Just as highway safety is wonky, the Ford Pinto was not, homeland security might seem wonky but preventing another 9/11 is not.
So, at the risk of being a bit wonky, here's CNN's Elizabeth Cohen.
(BEGIN VIDEOTAPE)
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT (voice-over): The Vioxx hearings have left many people wondering, how could a drug that causes heart attacks get approved by the Food and Drug Administration? Doesn't the United States have the best, most rigorous drug approval process in the world?
The answer to that question has to do with a common misperception. Many people think it's the FDA that conducts studies on drugs before they go on the market. In fact, the pharmaceutical companies do the studies on their own drugs. The FDA just reviews their data. And more and more observers, such as Dr. Jerry Avorn, author of the book "Powerful Medicines," thinks this system doesn't make much sense.
DR. JERRY AVORN: I think we need to have a more vigilant and aggressive FDA.
COHEN: One problem, he says, the salaries of the FDA reviewers are paid in part by the drug companies. The pharmaceutical industry spends hundreds of millions of dollars on so-called user fees to the FDA and some say that makes for too cozy of a relationship.
ALAN GOLDHAMMER, PHARMACEUTICAL RESEARCH AND MANUFACTURER'S ASSOCIATION OF AMERICA: We've seen these allegations of the coziness between the industry and the Food and Drug Administration. We think that they really are not true.
COHEN: In fact, the pharmaceutical industry says...
GOLDHAMMER: The process for approving new drugs by the Food and Drug Administration is working quite well.
COHEN: The industry points out that it spends years testing each drug on animals and then on humans and the FDA then takes about a year to review those studies and often asks for even more data. But others say that pulling Vioxx and other drugs off the market because of safety worries is proof that somehow, somewhere the system is falling short.
Elizabeth Cohen, CNN, Atlanta.
(END VIDEOTAPE)
BROWN: We're joined now from Boston by Dr. Jerry Avorn. He's the Associate Professor of Medicine at Harvard. And, from Philadelphia, Susan Dentzer, Health Correspondent for the "News Hour with Jim Lehrer," in partnership with the Henry J. Kaiser Family Foundation. And we are glad to see them both. Doctor, you just heard the industry representative say the process is working quite well. Buying that?
DR. JERRY AVORN, HARVARD MEDICAL SCHOOL: Well, I'm a little nervous that they're so comfortable with how well the process is working, because this really does need to be an arms-length adversarial kind of relationship, rather than a cozy one. And I think that it is true that there's too much coziness and not enough arm's- lengthness.
BROWN: Just on the question of Vioxx for a second, should it have been clear to Merck and to regulators prior to just really a few weeks ago, months or so ago, that Vioxx in fact should not have been on the market?
AVORN: Yes.
I think the confusion here comes from the question of, when did we know it and how much did we know when we knew it? It seems a little disingenuous for Merck to say on the one hand, we didn't want to do studies to clarify this in the beginning, and then to turn around and say, well, there was no evidence from studies to show there was a problem.
There was a signal as early as 1999-2000 that there was a reason to worry about heart attacks with Vioxx. And the prudent thing for Merck to have done and for FDA to have done at that point is to say, we don't know how substantial the signal is. Let's get to the bottom of it by doing the right kind of clinical trial and it could have been resolved by 2001 at the latest.
BROWN: Susan, is it as clear to you that the early studies of Vioxx raised enough red flags, if you will, to at least delay its introduction into the market?
SUSAN DENTZER, "THE NEWSHOUR WITH JIM LEHRER": I wouldn't say delay the introduction, although there is considerable debate. There were scientists saying that Merck should have known as early as 1996 that there was a role that the molecule, as they say in the business, was having in clotting.
And when you have clotting in coronary arteries, you can have a heart attack. So there is an argument that Merck should have known that there was a property of this drug going back to '96. The more persuasive argument, I think, is the argument that is made that says, in 2000, when the results were published of the so-called VIGOR study -- this was the study essentially that looked at Vioxx vs. a drug called naproxen...
BROWN: It's Aleve.
DENTZER: ... which a lot of people know as Aleve and other drugs.
BROWN: Right. DENTZER: That there was the data -- the analysis later showed a five-fold increase in heart attacks in the population that took Vioxx. That was a clear red flag.
And, at that point, the FDA and everybody else started to discuss what it meant, and the argument is, could they have moved faster at that point to develop more definitive evidence and pull the drug off the market?
(CROSSTALK)
BROWN: Now, on that study, Doctor, what Merck said in an effort, I think fairly, to protect its drug, is that is it argued that the Aleve had an aspirin-like quality that was helping it reduce the incidents of heart disease that Vioxx didn't have, but it wasn't that Vioxx was causing problems.
AVORN: Well, we actually looked at that. Dr. Dan Solomon and my division and I did a paper in which we looked at whether naproxen really does prevent heart attacks.
And we showed years and years ago that its cardioprotective effect was very, very modest, only about 15 percent, and nowhere near enough of a strong effect to have known the four- or five-fold effect that we saw with Vioxx being worse than naproxen.
BROWN: Is there any question in your mind that there are drugs out there that six months, a year from now, we're going to find out have side effects significant enough, because all drugs have some side effects, significant enough that they are too risky to be on the market?
AVORN: Well, what scares me, Aaron, is that I don't know the answer to that question. And it scares me because we've got drugs that have been on the market for a long time, like Vioxx. And I know one thing for sure, and that is that the FDA has not required the kind of post-marketing safety tests that many of us in the academic end of the world would like to see them do.
So I can't sit and tell you, don't worry about the SSRI antidepressants, don't worry Crestor, or don't worry about some of the other drugs that Dr. Graham mentioned, because I know that the data don't exist that I need to know that these drugs are safe.
BROWN: Susan, last word here, 20 seconds. Do you believe that what's happened with Vioxx is going to lead to some sort of fundamental change in how drugs are approved?
DENTZER: It certainly should.
And I wouldn't say so much approved as agree with Dr. Avorn that the real issue is, what do you do once drugs are approved? What do you do in terms of monitoring them? What essentially we do now is, we put a lot of long-term -- drugs for long-term use out on the market. We've got to study what the long-term effects are of those drugs. That's really where the change has to come about. BROWN: Both of you, thanks for your help tonight. Appreciate it. Thanks very much.
AVORN: Good to be here.
DENTZER: Happy to be here.
BROWN: Still to come on the program, free speech and a reporter's right to keep a source secret back on the table, and the spark that ignited the religious right, gay marriage in the state of Massachusetts, a year ago today.
A break first. This is NEWSNIGHT on CNN.
(COMMERCIAL BREAK)
BROWN: It seems like the last month or so has been bookend by stories about the culture wars, abortion on one end of the culture wars, gay marriage at the other.
If there was a single galvanizing moment in that fight, the gay marriage fight, it occurred not on Election Day earlier this month, but in Boston a year ago today. Gay marriage became legal, the battle joined. And a year later, what?
Here's CNN's Dan Lothian.
(BEGIN VIDEOTAPE)
DAN LOTHIAN, CNN BOSTON BUREAU CHIEF (voice-over): One year later in a Boston suburb, a symbolic burning of the Massachusetts Constitution by opponents of gay marriage, even as those who support it countered with music from across the street, then up close.
CROWD (singing): And we shall overcome.
LOTHIAN: A state still divided.
But Mary Bonauto, who led the fight for gay rights here, says, after more than 4,200 same-sex marriages, the climate is changing.
MARY BONAUTO, ATTORNEY, GAY AND LESBIAN ADVOCATES AND DEFENDERS: We are encouraged that people in Massachusetts have had the chance to experience Very personally, very firsthand that other people marrying, same-sex couples marrying And have protections has been good for those families and is taking nothing away from them.
LOTHIAN: State lawmakers who supported gay rights were not voted out of office, as was threatened, even though the judges are still being targeted politically. And advocates are in the courts fighting to allow out-of-state gay couples to legally marry here. But opponents are bolstered by what happened on Election Day, when 11 states passed anti-gay marriage laws and voters seemed motivated by moral values.
WILLIAM J. CLINTON, FORMER PRESIDENT OF THE UNITED STATES: With regard to the gay marriage issue, it was an overwhelming factor in the defeat of John Kerry. There's no question about it.
LOTHIAN: At the Massachusetts Family Institute, president Kris Mineau says the court decision was far from a setback.
KRISTIAN MINEAU, MASSACHUSETTS FAMILY INSTITUTE: I looked at it as an electrifying moment for the rest of America, a real wakeup call. I believe Massachusetts is being called to wake up.
LOTHIAN (on camera): And opponents hope state lawmakers will approve a proposed constitutional amendment banning gay marriage. That would allow voters to have the final say in two years.
(voice-over): The legal community says in one year Massachusetts has become the blueprint for this controversial fight.
DAVID YAS, "MASSACHUSETTS LAWYERS WEEKLY": Because of the fact that Massachusetts actually laid the groundwork for other judges to be able to step forward and say, yes, I agree with that judge in Massachusetts.
LOTHIAN: Or they could come to a different conclusion in this ongoing cultural war.
Dan Lothian, CNN, Boston.
(END VIDEOTAPE)
BROWN: To some of you, this next story will be called more whining from the media. We understand, even as we disagree.
Today, another reporter covering a high-profile case was ordered to jail for refusing to reveal a source. There are in this case no national security implications. This isn't about outing a CIA agent. It is a political corruption case and a piece of tape. And that fact, under federal law, reporters have no protection from prosecutors who are looking for leapers.
The story reported by CNN's Deborah Feyerick.
Well, not quite. We'll take a break and we'll try again. We'll be right back.
(COMMERCIAL BREAK)
BROWN: OK, we'll try this again.
In federal court in Rhode Island today, a judge ordered a reporter to jail for refusing to tell that judge and to tell a special prosecutor who gave him a piece of tape in a political corruption case.
Here's Deborah Feyerick.
(BEGIN VIDEOTAPE)
DEBORAH FEYERICK, CNN CORRESPONDENT (voice-over): Calling the guilty verdict an assault on journalistic freedom, investigative reporter Jim Taricani said he'd continue protecting the identity of his source.
JIM TARICANI, WJAR REPORTER: I made a promise to my source, which I intend to keep.
FEYERICK: A federal judge finding that promise directly defies a court order, one requiring the reporter to divulge who gave him a copy of an FBI surveillance tape.
TARICANI: But, when people are afraid, a promise of confidentiality may be the only way to get the information to the public.
FEYERICK: The tape shows a top aide to the former Providence, Rhode Island, mayor taking a cash bribe inside City Hall. Both men would later be found guilty of corruption. But at the time the tape aired on the local NBC station, everyone involved in the case was under a gag order, the judge saying he didn't object to airing the tape. He objected that someone had broken the law by giving it to the reporter in the first place.
Rhode Island legal expert Edward Roy (ph).
UNIDENTIFIED MALE: It is extremely rare, I think, for someone to have defied a court order, as Mr. Taricani did, although I think the difference in this context is, from what I understand, his argument is that he was basing it on his First Amendment rights as a journalist.
FEYERICK: Taricani is one of a dozen reporters around the country risking fines or prison for not revealing sources. Others are under investigation for source leaks concerning former Los Alamos scientist Wen Ho Lee and outed CIA agent Valerie Plame. Free speech experts say prosecuting journalists could have a chilling effect.
JOSEPH CAVANAGH, FIRST AMENDMENT ATTORNEY: There's an important element of the First Amendment that's being infringed, and that is the ability to gather information.
FEYERICK (on camera): Taricani has paid $85,000 in fines. Those fines and his legal fees are being covered by his network. He faces up to six months in prison when he's sentenced in December and is now deciding whether to appeal. Because he received a heart transplant several years ago, his big concern is the impact prison might have on his health.
Deborah Feyerick, CNN, Providence, Rhode Island.
(END VIDEOTAPE)
BROWN: We spoke early in the program about the decision to lead a country into war. We deal now with decisions on a scale much less grand, but no less consequential.
Taking a country to war means taking Salina, Kansas, or Greensburg, Pennsylvania, or Brentwood, Long Island. (BEGIN VIDEOTAPE)
CHRIS CHAMBERLIN, ENGLISH TEACHER, BRENTWOOD HIGH SCHOOL: We've lost three students in the war, two in Iraq and one in Afghanistan, one African-American, one Latino and one Caucasian. That's who we are. They are a slice of Brentwood.
BETTY BROWN-GREEN, DEAN, BRENTWOOD HIGH SCHOOL: Very big loss. In Brentwood, we are a family. And when something happens, we come together as a community. And you feel it. Whether it was Raheen Heighter, Michael Esposito, or Ramon Mateo, it's like losing one of our children. So it was very painful.
Raheen was ahead of his time. He was bright. He was intelligent. He was headstrong. Raheen was a go-getter.
SGT. ARTHUR BURGESS, BRENTWOOD HIGH SCHOOL ROTC PROGRAM: Michael was a, I would say a 110-pound kid soaking wet. He was very close to me. Occasionally, when I step out in the hall, I can still see a little, thin kid dressed in his camouflage BDU standing in the hallway saying, hey, Sarge. So he was one of the good ones.
LINDA PAPPERT, ASSISTANT PRINCIPAL, BRENTWOOD HIGH SCHOOL: And Ramon was the kind that he had this energy. He had this wonderful charisma, but he needed to know how to focus it. And he knew he needed the military to kind of grab it together for him. And he went.
And when he came back, he knew it. You could see he was happy. He was just very proud of himself. And there he was in his uniform, looking handsome.
THOMAS O'BRIEN, PRINCIPAL, BRENTWOOD HIGH SCHOOL: In each of these cases, we had an evening event here at the high school and presented a memorial plaque on behalf of the Brentwood School District. That's hung in our lobby. There are two now. The parents of Ramon still have his. We give them to them for a couple of weeks. And they bring them back and we mount them on the wall in our Wall of Honor outside.
It's a very working-class community, where about 62 percent of our families live below the federal poverty line. For either a two- year or a four-year college experience, many look to other avenues to finance that, one being, you know, veterans benefits.
CHAMBERLIN: since I was in the Marine Corps for four years, which helped me go college, I'm one of the people they come to discuss that as an avenue for their future.
He's someone alive from Brentwood serving in this war.
In a great irony, the publicity that all of this has received, I have even more students now that want to join.
ROBERT SMITH, BRENTWOOD HIGH SCHOOL JUNIOR: To see them just in their uniforms, proud, it affects me. It gives me this feeling that they died doing something great for us. RYAN RAMKISSOON, BRENTWOOD HIGH SCHOOL SENIOR: The military's always been a dream for me, just to defend my nation. If I die, well, I'll be remembered as a soldier, as a patriot.
CHAMBERLIN: All of these kids feel immortal. I think that's any kid anywhere at 18.
I'm an educator. Educate them as much as possible about the war, about politics, through literature. If anything was happen to them, would it kill me? Yes, absolutely. Yes, it's going to crush me.
PAPPERT: What I thought coming out of that assembly the other night, thinking, we're going to add another picture to that wall, and I was thinking, oh, God, I hope that never becomes full.
O'BRIEN: I feel very proud of the fact that they chose to put their lives at risk for what they believed was right and what they believed was good and, in fact, to put their lives on the line, so that others didn't have to. I hope that their sacrifice reaches the goals for which it was intended.
(END VIDEOTAPE)
(COMMERCIAL BREAK)
(ROOSTER CROWING)
BROWN: Okeydokey, time to check morning papers from around the country, around the world.
We'll begin, actually, with a tale of two headlines. "The International Herald Tribune," published by "The New York Times" in Paris. Over there, OK? "Elections in Iraq Now Seem in Doubt. Sunni Leaders, Iraqi Prime Minister Say Order Must Be Restored Before Ballot." OK, that's the headline there.
Now "The Washington Times" headline: "U.S. Declares Insurgency Broken. Military Also Says Bin Laden Is Cut Off." I hope "The Washington Times" is right. But I'm kind of worried that maybe the light is not at the end of the tunnel yet. Anyway, that's how they headline it. This is the story that I really look forward to reading most, though, "Spreading the Word on Farewell Tour, Billy Graham Returns to California." Dr. Graham is 86 years old now. And this is his last swing around the country. He's battled some health issues, but he's going to do it. And God bless him for it.
"Stars and Stripes." "Powell: Iran Fitting Missiles for Nukes" is their lead. Why did I like this? I don't know.
"The Philadelphia Inquirer" leads with Vioxx. "Two Vioxx Critics Allege Pressure." "Specter Wins Panel's Backing." Finally, we've hopefully seen the end now of the Arnold -- Arlen, not Arnold -- Arlen Specter story.
"Kmart May Lose Its Identity" the lead in "The Detroit News." For those who once worked at Kmart -- and I did -- attention, Kmart shoppers, in the next 10 minutes and 10 minutes only -- in Connellsville, Pennsylvania. Anyway, that's sort of sad.
The weather tomorrow in Chicago, by the way...
(CHIMES)
BROWN: How does that happen every night? "Bleak."
We'll wrap it up in a moment.
(COMMERCIAL BREAK)
BROWN: We're a little late tonight.
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 November 18, 2004 - 22:00 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
AARON BROWN, CNN ANCHOR: Good evening again.
The center of the program tonight deals with an issue that touches every one of you no matter your age, your gender, your politics, your station in life. Are the medicines you take, or at least the risks of those medicines because all medicines have some risks, are they known and understood? Are drug companies in their search for both cures and profits allowed to hide the dangers of drugs? Is the FDA too cozy with those it's supposed to regulate?
None of these questions has an easy answer but there are some clues tonight, some hints. "The Washington Post" reported today that over the last four years, the FDA has been less aggressive in policing drugs than it used to be.
From recalls to warning letters, there has been a dramatic decrease in regulation and that, according to "The Post," even as evidence of adverse affects from new drugs has been rising dramatically, enforcement has slackened. So, tonight we'll take a look at the process and the politics and wonder has the balance shifted away from safety toward something else?
The whip begins with CNN's Chris Huntington, Chris start us off with a headline.
CHRIS HUNTINGTON, CNN CORRESPONDENT: Aaron, there's a new whistle-blower in Washington. FDA scientist David Graham says the nation's drug safety program is broken and that his bosses at the FDA tried to keep him from reporting that Vioxx may have caused 100,000 heart attacks -- Aaron.
BROWN: Chris, thank you. We'll get to you at the top tonight.
Next to Falluja and a discovery there, CNN's Jane Arraf is still in the city with the Army's 1st Infantry, Jane a headline tonight.
JANE ARRAF, CNN BAGHDAD BUREAU CHIEF: Aaron, American troops looking behind doors in Falluja's abandoned southeast are making some chilling finds.
BROWN: Jane, thank you.
And finally another skirmish in the battle between the government and reporters wanting to keep their sources secret, CNN's Deborah Feyerick with that for us, Deb a headline. DEBORAH FEYERICK, CNN CORRESPONDENT: Aaron, a journalist possibly heading to prison after a federal judge finds the reporter guilty of criminal contempt for refusing to reveal the identity of the source -- Aaron.
BROWN: Deb, thank you. We'll get back to you and the rest shortly.
Also on the program tonight, Massachusetts and gay marriage, a year and a presidential election later, where do things stand?
Also tonight, at a high school on Long Island a reminder of the price of war, the war in Iraq and Afghanistan, three students who volunteered, three students remembered.
And morning papers, the rooster, the wind chimes, the weather and all wrap up the hour, lots to do in the hour ahead.
We begin tonight with Vioxx, a little yellow pill that, along with others like it, was supposed to revolutionize the treatment of long term pain, which made it a golden pill worth billions of dollars to Merck, the manufacturer.
Then reports of fatal side effects started coming out. The company pulled the drug but said it had done no wrong. The FDA said likewise. Today, questions from Congress began.
We cover the story from a number of angles tonight, beginning first with CNN's Chris Huntington.
(BEGIN VIDEOTAPE)
HUNTINGTON (voice-over): FDA scientist David Graham testified that he estimates Vioxx caused more than 100,000 heart attacks, 30 to 40 percent of them fatal but Graham told members of the Senate Finance Committee that his FDA superiors ridiculed him and insisted on changes.
DR. DAVID GRAHAM, ASSOCIATE DIRECTOR FOR SCIENCE FDA: When I was pressured to change my conclusions and recommendations. One drug safety manager recommended that I should be barred from presenting the poster at the meeting and also noted that Merck needed to know our study results.
HUNTINGTON: Graham offered a blistering condemnation of the FDA's drug safety program saying that the system is broken and often overlooks the dangers of drug side effects.
GRAHAM: The FDA as currently configured is incapable of protecting America against another Vioxx.
HUNTINGTON: A senior FDA official responsible for evaluating new drugs flatly dismissed Graham's assessment and rejected his contention that several drugs still on the market, including Bextra, a Cox-II inhibitor from Pfizer, are dangerous and should be recalled.
UNIDENTIFIED MALE: Do you agree with Dr. Graham that five drugs he mentioned pose a significant safety risk to Americans?
UNIDENTIFIED FEMALE: No, I do not.
HUNTINGTON: Testifying via satellite, a former Merck consultant told lawmakers that the company refused his request for data on Vioxx related heart attacks. And, another doctor disputed Merck's central points that heart attacks occurred only in those who took the drug for more than 18 months.
UNIDENTIFIED MALE: Merck lacked information to know when the risk occurred and you cannot say with confidence given the available data.
HUNTINGTON: Merck Chairman and CEO Ray Gilmartin presented a well honed defense of his company and Vioxx insisting that the first time Merck saw clinical evidence of heart attacks linked to Vioxx was just a week before the drug was pulled from the market in late September.
DR. RAYMOND GILMARTIN, CHAIRMAN, PRESIDENT AND CEO, MERCK: Merck believed wholeheartedly in Vioxx. I believed wholeheartedly in Vioxx. In fact, my wife was taking Vioxx, using Vioxx up until the day we withdrew it from the market.
(END VIDEOTAPE)
HUNTINGTON: Now, Gilmartin added that David Graham's estimate of Vioxx-related heart attacks played no role in Merck's decision to pull Vioxx off the market but it was clear from the committee members' reaction that Graham's testimony may well be a catalyst for overhauling the FDA's drug program -- Aaron.
BROWN: We have a long way to go on this tonight. Let me just start with one question. It's not factually correct to say, this is the question, that there was no evidence of a cardiovascular problem with Vioxx before this spring, correct?
HUNTINGTON: Correct. There was -- what Merck is holding to is clinical data. Now, I'm going to get bogged down, I could get bogged down in the medical difference between an epidemiological study and a clinical study but that's where Merck wants to draw the defense line.
There was plenty of evidence, in fact, even some early speculative evidence that Merck was well aware of back in 1996. That was a document, in fact, that came out in the hearing today.
So, plenty of talk in the medical community about the cardiovascular dangers of Vioxx but as far as Merck is concerned, there was no clinical data that drew the link between the drug and heart failure until this study that they are, you know, showing up in late September the reason that they cite for taking the drug off the market.
BROWN: Chris, thank you. You danced around that epidemiological question pretty well. The difference in a sentence basically is clinical means this heart attack was caused by this drug, as opposed to a body of statistics which seems to suggest that heart attacks were caused by the drug. Keep that in mind because it's going to come up a fair amount tonight. We have a lot of questions to ask on this.
Later in the program we'll talk with Senator Grassley of Iowa, who chaired the hearings today. A panel of experts join us as well.
We want to deal with some of the other news of the day first and that begins in Falluja and more reminders of not just the price but also the uncertain nature of the victory.
The cost in American casualties for the battle of Falluja now stands at 51 dead, 425 wounded. The uncertainty lies in holding the city and especially in dealing with the insurgents who scattered to other parts of the country, a reminder of that problem in particular could be found in a house on a street in Falluja today.
So, from Falluja tonight, here's CNN's Jane Arraf.
(BEGIN VIDEOTAPE)
ARRAF (voice-over): The gunmen inside the house and in underground bunkers fought ferociously and died violently.
LT. COL. PETE NEWELL, U.S. ARMY 1ST INFANTRY DIVISION: This one open area is where we hit probably the stiffest resistance of the four days we really spent clearing house-to-house and block-to-block.
ARRAF: Outside the houses were fighting positions and explosives. Inside were some clues as to why they fought so hard. This Iraqi commander says two men, whose names are written next to this al Qaeda mural were believed to be the top lieutenants of Abu Musab al-Zarqawi in this sector.
UNIDENTIFIED MALE (through translator): What we found here is al Qaeda's operation in Falluja. This is where the operations were orchestrated from. This is very important. This is the base where they moved from, where they organized their resistance, where they operated from.
ARRAF: He says he read a letter signed by Zarqawi who describes himself as their little brother, asking for an update on their operations and their fighters. He tells us another letter from one of the men, who calls himself Abu Moussa Mushami al-Lugnani (ph) asks Zarqawi for funds and fighters.
In this modest house was a computer with the hard drive removed. Throughout, clothing was scattered on the floor, even food and personal photos. There were also more sinister finds.
(on camera): This building was also part of the complex apparently. In this back room they found a pile of landmines and antitank mines. Some of them had the explosives removed. That's the way that they commonly make homemade bombs. Also here lying on the floor are what's left of surgical supplies, sutures and band-aids.
(voice-over): A third of a mile away in Falluja's deserted industrial section, Alpha Company troops made more chilling discoveries what appeared to be a repair shop for antiaircraft guns and a makeshift classroom.
CAPTAIN DOUG WALTER, U.S. ARMY 1ST INFANTRY DIVISION: On the board itself they had sketches of the -- of aircraft and F-16, F-18 in parenthesis, apparently some kind of training room on how to shoot down U.S. aircraft. And then in the rest of the building antiaircraft weapons in various stages of disrepair. We think this was like a maintenance shop.
ARRAF: Close by an apparent car bomb factory. On this work table were pieces of shrapnel and bomb making materials. This vehicle registered in Texas had parts of it ripped out presumably to pass with explosives, soldiers say. A few feet away were enough bags of sodium nitrate and ammonium nitrate to kill dozens. More doors opened into the hidden terror of this city.
(END VIDEOTAPE)
ARRAF: And these weren't entirely unique. This entire section, Aaron, is dotted with what could be factories to make car bombs or what could be weapons depots and that is just one section of the city -- Aaron.
BROWN: We didn't really see a wide shot. Was this a house standing alone? Is it in the middle of a neighborhood and, if it's in the middle of a neighborhood, is it even conceivable that people who lived around there didn't know what was going on there?
ARRAF: You know that was the interesting thing about this neighborhood, about this sector. The civilians had been driven out weeks, if not months ago and essentially what the troops found when they rolled in here was an entire section of the city, the eastern side, where they had taken over. The insurgents had taken over the neighborhood, expelled the civilians. They took over the houses and they fortified them -- Aaron.
BROWN: Jane, thank you, Jane Arraf in Falluja again for us tonight.
Today, the commander of the Marine division that battled its way into Falluja said the insurgency's back has been broken. Also today, "The New York Times" reported that the general's own intelligence officers have prepared a written assessment of the situation that is a whole lot less optimistic.
If troop levels are reduced in Falluja, they warn, the insurgents will bounce back there. The Iraqi troops are not yet ready to defend the city. Their bosses in Washington and in Baghdad disagree with the conclusions on the ground and decides there is plenty of evidence those troops are needed elsewhere in the country as well.
With that part of the story tonight, CNN's Karl Penhaul.
(BEGIN VIDEOTAPE) KARL PENHAUL, CNN CORRESPONDENT (voice-over): Homes lie in ruins. Unidentified corpses rot under Falluja's rubble. The Iraqi government says it's victory.
THAIR AL NAKIB, IRAQI PM SPOKESMAN (through translator): Falluja is no longer a stronghold or a haven for the terrorists. That battle has been won and we need only a few days to liquidate all the terrorists.
PENHAUL: That may be easier said than done. U.S. commanders say some insurgents escaped Falluja. It's not clear how many. Rebel violence has spiked in other cities.
During Wednesday night and Thursday, insurgents battle security forces in Ramadi. In Baghdad, a car bomb exploded outside a police station killing and wounding civilians. And, in Mosul, the provincial governor's office was mortared. The Iraqi government seemed un- phased. Thursday morning, insurgent gunmen could still be seen freely roaming the streets.
In the city of Falluja, the Iraqi government says it's offering food and $100 subsidy to each family, the prime minister sending deputies to the city this weekend to assess damage and plan reconstruction.
As yet there's no accurate independent assessment of the civilian casualty toll. Marines halted an offensive there in April, partly because of a political backlash against civilian casualties.
The U.S. military says it's not responsible for counting this time, referring all queries to the Iraqi government, which last week said only 14 civilians had been injured. Judging by al-Nakib's response...
AL NAKIB: I'm not going to get into numbers, sorry.
PENHAUL: ...the Iraqi government seems to be tired of answering questions about the human cost of its victory in Falluja.
Karl Penhaul, CNN, Baghdad.
(END VIDEOTAPE)
BROWN: The decision to take this country to war is a decision known to just a handful of men alive today. Only a president can make that decision. And, in that regard presidents, current and former, share a unique bond that even in our divided land transcends politics.
Today in Little Rock, four presidents, one building, different politics, common bond, the opening of the Clinton Library reported for us by CNN's Candy Crowley.
(BEGIN VIDEOTAPE)
CANDY CROWLEY, CNN SR. POLITICAL CORRESPONDENT (voice-over): The weather was completely miserable, wet, cold and windy but how many times can you see Bono and four U.S. presidents in the same place?
JIMMY CARTER, FORMER PRESIDENT OF THE UNITED STATES: But at the end of a very difficult political year, more difficult for some of us than others, it is valuable for the world to see two Democrats and two Republicans assembled together all honoring the great nation that has permitted us to serve.
CROWLEY: It was like a meeting of the world's most elite, most unlikely club, gathered to vet one of its own, part high ceremony, part rotary club.
GEORGE W. BUSH, PRESIDENT OF THE UNITED STATES: A fellow in Saline County was asked by his son why he liked Governor Clinton so much. He said, "Son, he'll look you in the eye. He'll shake your hand. He'll hold your baby. He'll pet your dog all at the same time."
GEORGE H.W. BUSH, FORMER PRESIDENT OF THE UNITED STATES: Simply put, he was a natural and he made it look too easy and, oh, how I hated him for that.
CROWLEY: The natural, looking pale and smaller since heart surgery, is still the master politician, sweetened now by the touch of an elder statesman.
BILL CLINTON, FORMER PRESIDENT OF THE UNITED STATES: I once said to a friend of mine about three days before the election and I heard all these terrible things, I said "You know, am I the only person in the entire United States of America who likes both George W. Bush and John Kerry, who believes they're both good people who believe they both love our country and they just see the world differently?"
CROWLEY: He has put together the biggest, most expensive presidential library yet, filled with more objects, more paperwork than any previous administration. It is so very Bill Clinton.
SEN. HILLARY CLINTON (D), NEW YORK: The building is like my husband. It's open. It's expansive. It's welcoming. It's filled with life.
CROWLEY: Candy Crowley, CNN, Little Rock.
(END VIDEOTAPE)
BROWN: Ahead on the program tonight another reporter sent to jail for refusing to name a source.
And a high school has a lot to be proud of but also the tears to show for it, students who answered the call to war, a break first.
From New York this is NEWSNIGHT.
(COMMERCIAL BREAK)
BROWN: More now on the Vioxx problem. Some would argue that it's not just a Vioxx problem, the FDA problem more like it because of the relationship the FDA has now with pharmaceutical companies.
About a dozen years ago at the height of the AIDS epidemic, the FDA came under fire for being too tough on drug companies, too slow. Congress stepped in and has since allowed the companies to help pay the FDA staff. As a consequence, fewer drugs have been forced off the market and some congressional leaders say that now must change.
(BEGIN VIDEO CLIP)
SEN. CHARLES GRASSLEY (R), IOWA: One of my concerns is that the FDA has a relationship with drug companies that is far too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be FDA's first and only concern.
(END VIDEO CLIP)
BROWN: Senator Grassley made those statements at the hearings today, hearings he chaired and he joins us now from Washington. He's the chairman of the Senate Finance Committee, a Republican from Iowa, and it's good to see you sir.
You suggested today that maybe there needs to be an independent panel that reviews the work the FDA does. Isn't that what the FDA is supposed to do in the first place?
GRASSLEY: Yes. There is specifically an Office of Drug Safety that is connected with the Office of New Drugs and there's a relationship between those organizations before a drug gets on the market.
So then, the Office of Drug Safety then finds out later on that there's something wrong, then that makes the Office of New Drugs look bad. So, I think that we need to separate, well just completely separate and make independent the Office of Drug Safety.
BROWN: Let me ask, it's the only really political question I'm going to ask tonight but it's sort of a delicate one, to what extent do you think it's possible that the whole anti-regulatory belief structure of your party has contributed to the situation we find ourselves in?
GRASSLEY: Well, I don't hesitate to answer that because you asked a political question and it involves my party. The problem is I just don't know. You know there's always accusations but I consider some demagoguery connected with it when there's an accusation just because you take campaign contributions or because you're a big corporation that you're necessarily affiliated with the Republican Party.
I'm a Republican all my life, a conservative Republican, a supporter of the president and I even take campaign contributions from pharmaceutical companies and probably have even taken from Merck. You know, I don't keep track of everything I get but it hasn't stopped me from taking them on.
BROWN: No, it certainly has not and that's really not -- I'm just wondering if -- and it's not really just Republicans. I mean some famous Democrat once said the era of big government is over. If we're in a time when we want less regulation, don't we -- might we not find ourselves in situations where we are paying the price for too little regulation?
GRASSLEY: Well, the argument is very appropriate for where we are now because maybe ten years ago the public policy debate was how long it was taking to get a miracle drug onto the market and how many people were dying because the miracle drug wasn't available? And now here we are beating the same organization over the head because they aren't enough concerned about safety.
I can pass a law. It calls for efficacy of a drug. It calls for safety of a drug. Those are 40-year-old laws. You know you can write a law but you've got to account to the administrators to carry it out according to our spirit. All I can do is make sure that I do my constitutional job of oversight.
BROWN: David Graham today talked about five drugs, one dealing with anti-cholesterol, asthma, weight loss, pain, just something for everybody pretty much in your medicine cabinet that he felt still -- drugs still out there and still dangerous and the FDA said, "No, everything's fine. Don't worry." Do you believe everything's fine, don't worry?
GRASSLEY: I think I got a lot of confidence in the doctor. Here's the thing though that concerns me, not just what he said today but just this year we had two instances of one with the antidepressant and its effect on suicide by children and we had a scientist earlier this year say that there was a great deal of concern about it. He was suppressed. Eventually he won out and there's a warning on there now.
Now we have this situation with Dr. Graham and Vioxx and there's too much effort to not let the scientific process work within FDA. I think the scientific process by which one scientist discovers something and it has to be reviewed, a peer review by other scientists, is just about as non-political as you can get but when that process is suppressed by the agency, then the public safety is not being protected the way it should be protected.
BROWN: Senator, it's always good to see you. Thanks for your work today.
GRASSLEY: You bet, Aaron.
BROWN: This is a great and important issue.
Still to come, how the FDA approves drugs, including Vioxx, followed by a discussion on whether that procedure needs to change in the wake of what we now know, a break first.
Around the world this is NEWSNIGHT.
(COMMERCIAL BREAK)
BROWN: Vioxx is both a medical story and a process story and process stories can be a bit wonky. Just as highway safety is wonky, the Ford Pinto was not, homeland security might seem wonky but preventing another 9/11 is not.
So, at the risk of being a bit wonky, here's CNN's Elizabeth Cohen.
(BEGIN VIDEOTAPE)
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT (voice-over): The Vioxx hearings have left many people wondering, how could a drug that causes heart attacks get approved by the Food and Drug Administration? Doesn't the United States have the best, most rigorous drug approval process in the world?
The answer to that question has to do with a common misperception. Many people think it's the FDA that conducts studies on drugs before they go on the market. In fact, the pharmaceutical companies do the studies on their own drugs. The FDA just reviews their data. And more and more observers, such as Dr. Jerry Avorn, author of the book "Powerful Medicines," thinks this system doesn't make much sense.
DR. JERRY AVORN: I think we need to have a more vigilant and aggressive FDA.
COHEN: One problem, he says, the salaries of the FDA reviewers are paid in part by the drug companies. The pharmaceutical industry spends hundreds of millions of dollars on so-called user fees to the FDA and some say that makes for too cozy of a relationship.
ALAN GOLDHAMMER, PHARMACEUTICAL RESEARCH AND MANUFACTURER'S ASSOCIATION OF AMERICA: We've seen these allegations of the coziness between the industry and the Food and Drug Administration. We think that they really are not true.
COHEN: In fact, the pharmaceutical industry says...
GOLDHAMMER: The process for approving new drugs by the Food and Drug Administration is working quite well.
COHEN: The industry points out that it spends years testing each drug on animals and then on humans and the FDA then takes about a year to review those studies and often asks for even more data. But others say that pulling Vioxx and other drugs off the market because of safety worries is proof that somehow, somewhere the system is falling short.
Elizabeth Cohen, CNN, Atlanta.
(END VIDEOTAPE)
BROWN: We're joined now from Boston by Dr. Jerry Avorn. He's the Associate Professor of Medicine at Harvard. And, from Philadelphia, Susan Dentzer, Health Correspondent for the "News Hour with Jim Lehrer," in partnership with the Henry J. Kaiser Family Foundation. And we are glad to see them both. Doctor, you just heard the industry representative say the process is working quite well. Buying that?
DR. JERRY AVORN, HARVARD MEDICAL SCHOOL: Well, I'm a little nervous that they're so comfortable with how well the process is working, because this really does need to be an arms-length adversarial kind of relationship, rather than a cozy one. And I think that it is true that there's too much coziness and not enough arm's- lengthness.
BROWN: Just on the question of Vioxx for a second, should it have been clear to Merck and to regulators prior to just really a few weeks ago, months or so ago, that Vioxx in fact should not have been on the market?
AVORN: Yes.
I think the confusion here comes from the question of, when did we know it and how much did we know when we knew it? It seems a little disingenuous for Merck to say on the one hand, we didn't want to do studies to clarify this in the beginning, and then to turn around and say, well, there was no evidence from studies to show there was a problem.
There was a signal as early as 1999-2000 that there was a reason to worry about heart attacks with Vioxx. And the prudent thing for Merck to have done and for FDA to have done at that point is to say, we don't know how substantial the signal is. Let's get to the bottom of it by doing the right kind of clinical trial and it could have been resolved by 2001 at the latest.
BROWN: Susan, is it as clear to you that the early studies of Vioxx raised enough red flags, if you will, to at least delay its introduction into the market?
SUSAN DENTZER, "THE NEWSHOUR WITH JIM LEHRER": I wouldn't say delay the introduction, although there is considerable debate. There were scientists saying that Merck should have known as early as 1996 that there was a role that the molecule, as they say in the business, was having in clotting.
And when you have clotting in coronary arteries, you can have a heart attack. So there is an argument that Merck should have known that there was a property of this drug going back to '96. The more persuasive argument, I think, is the argument that is made that says, in 2000, when the results were published of the so-called VIGOR study -- this was the study essentially that looked at Vioxx vs. a drug called naproxen...
BROWN: It's Aleve.
DENTZER: ... which a lot of people know as Aleve and other drugs.
BROWN: Right. DENTZER: That there was the data -- the analysis later showed a five-fold increase in heart attacks in the population that took Vioxx. That was a clear red flag.
And, at that point, the FDA and everybody else started to discuss what it meant, and the argument is, could they have moved faster at that point to develop more definitive evidence and pull the drug off the market?
(CROSSTALK)
BROWN: Now, on that study, Doctor, what Merck said in an effort, I think fairly, to protect its drug, is that is it argued that the Aleve had an aspirin-like quality that was helping it reduce the incidents of heart disease that Vioxx didn't have, but it wasn't that Vioxx was causing problems.
AVORN: Well, we actually looked at that. Dr. Dan Solomon and my division and I did a paper in which we looked at whether naproxen really does prevent heart attacks.
And we showed years and years ago that its cardioprotective effect was very, very modest, only about 15 percent, and nowhere near enough of a strong effect to have known the four- or five-fold effect that we saw with Vioxx being worse than naproxen.
BROWN: Is there any question in your mind that there are drugs out there that six months, a year from now, we're going to find out have side effects significant enough, because all drugs have some side effects, significant enough that they are too risky to be on the market?
AVORN: Well, what scares me, Aaron, is that I don't know the answer to that question. And it scares me because we've got drugs that have been on the market for a long time, like Vioxx. And I know one thing for sure, and that is that the FDA has not required the kind of post-marketing safety tests that many of us in the academic end of the world would like to see them do.
So I can't sit and tell you, don't worry about the SSRI antidepressants, don't worry Crestor, or don't worry about some of the other drugs that Dr. Graham mentioned, because I know that the data don't exist that I need to know that these drugs are safe.
BROWN: Susan, last word here, 20 seconds. Do you believe that what's happened with Vioxx is going to lead to some sort of fundamental change in how drugs are approved?
DENTZER: It certainly should.
And I wouldn't say so much approved as agree with Dr. Avorn that the real issue is, what do you do once drugs are approved? What do you do in terms of monitoring them? What essentially we do now is, we put a lot of long-term -- drugs for long-term use out on the market. We've got to study what the long-term effects are of those drugs. That's really where the change has to come about. BROWN: Both of you, thanks for your help tonight. Appreciate it. Thanks very much.
AVORN: Good to be here.
DENTZER: Happy to be here.
BROWN: Still to come on the program, free speech and a reporter's right to keep a source secret back on the table, and the spark that ignited the religious right, gay marriage in the state of Massachusetts, a year ago today.
A break first. This is NEWSNIGHT on CNN.
(COMMERCIAL BREAK)
BROWN: It seems like the last month or so has been bookend by stories about the culture wars, abortion on one end of the culture wars, gay marriage at the other.
If there was a single galvanizing moment in that fight, the gay marriage fight, it occurred not on Election Day earlier this month, but in Boston a year ago today. Gay marriage became legal, the battle joined. And a year later, what?
Here's CNN's Dan Lothian.
(BEGIN VIDEOTAPE)
DAN LOTHIAN, CNN BOSTON BUREAU CHIEF (voice-over): One year later in a Boston suburb, a symbolic burning of the Massachusetts Constitution by opponents of gay marriage, even as those who support it countered with music from across the street, then up close.
CROWD (singing): And we shall overcome.
LOTHIAN: A state still divided.
But Mary Bonauto, who led the fight for gay rights here, says, after more than 4,200 same-sex marriages, the climate is changing.
MARY BONAUTO, ATTORNEY, GAY AND LESBIAN ADVOCATES AND DEFENDERS: We are encouraged that people in Massachusetts have had the chance to experience Very personally, very firsthand that other people marrying, same-sex couples marrying And have protections has been good for those families and is taking nothing away from them.
LOTHIAN: State lawmakers who supported gay rights were not voted out of office, as was threatened, even though the judges are still being targeted politically. And advocates are in the courts fighting to allow out-of-state gay couples to legally marry here. But opponents are bolstered by what happened on Election Day, when 11 states passed anti-gay marriage laws and voters seemed motivated by moral values.
WILLIAM J. CLINTON, FORMER PRESIDENT OF THE UNITED STATES: With regard to the gay marriage issue, it was an overwhelming factor in the defeat of John Kerry. There's no question about it.
LOTHIAN: At the Massachusetts Family Institute, president Kris Mineau says the court decision was far from a setback.
KRISTIAN MINEAU, MASSACHUSETTS FAMILY INSTITUTE: I looked at it as an electrifying moment for the rest of America, a real wakeup call. I believe Massachusetts is being called to wake up.
LOTHIAN (on camera): And opponents hope state lawmakers will approve a proposed constitutional amendment banning gay marriage. That would allow voters to have the final say in two years.
(voice-over): The legal community says in one year Massachusetts has become the blueprint for this controversial fight.
DAVID YAS, "MASSACHUSETTS LAWYERS WEEKLY": Because of the fact that Massachusetts actually laid the groundwork for other judges to be able to step forward and say, yes, I agree with that judge in Massachusetts.
LOTHIAN: Or they could come to a different conclusion in this ongoing cultural war.
Dan Lothian, CNN, Boston.
(END VIDEOTAPE)
BROWN: To some of you, this next story will be called more whining from the media. We understand, even as we disagree.
Today, another reporter covering a high-profile case was ordered to jail for refusing to reveal a source. There are in this case no national security implications. This isn't about outing a CIA agent. It is a political corruption case and a piece of tape. And that fact, under federal law, reporters have no protection from prosecutors who are looking for leapers.
The story reported by CNN's Deborah Feyerick.
Well, not quite. We'll take a break and we'll try again. We'll be right back.
(COMMERCIAL BREAK)
BROWN: OK, we'll try this again.
In federal court in Rhode Island today, a judge ordered a reporter to jail for refusing to tell that judge and to tell a special prosecutor who gave him a piece of tape in a political corruption case.
Here's Deborah Feyerick.
(BEGIN VIDEOTAPE)
DEBORAH FEYERICK, CNN CORRESPONDENT (voice-over): Calling the guilty verdict an assault on journalistic freedom, investigative reporter Jim Taricani said he'd continue protecting the identity of his source.
JIM TARICANI, WJAR REPORTER: I made a promise to my source, which I intend to keep.
FEYERICK: A federal judge finding that promise directly defies a court order, one requiring the reporter to divulge who gave him a copy of an FBI surveillance tape.
TARICANI: But, when people are afraid, a promise of confidentiality may be the only way to get the information to the public.
FEYERICK: The tape shows a top aide to the former Providence, Rhode Island, mayor taking a cash bribe inside City Hall. Both men would later be found guilty of corruption. But at the time the tape aired on the local NBC station, everyone involved in the case was under a gag order, the judge saying he didn't object to airing the tape. He objected that someone had broken the law by giving it to the reporter in the first place.
Rhode Island legal expert Edward Roy (ph).
UNIDENTIFIED MALE: It is extremely rare, I think, for someone to have defied a court order, as Mr. Taricani did, although I think the difference in this context is, from what I understand, his argument is that he was basing it on his First Amendment rights as a journalist.
FEYERICK: Taricani is one of a dozen reporters around the country risking fines or prison for not revealing sources. Others are under investigation for source leaks concerning former Los Alamos scientist Wen Ho Lee and outed CIA agent Valerie Plame. Free speech experts say prosecuting journalists could have a chilling effect.
JOSEPH CAVANAGH, FIRST AMENDMENT ATTORNEY: There's an important element of the First Amendment that's being infringed, and that is the ability to gather information.
FEYERICK (on camera): Taricani has paid $85,000 in fines. Those fines and his legal fees are being covered by his network. He faces up to six months in prison when he's sentenced in December and is now deciding whether to appeal. Because he received a heart transplant several years ago, his big concern is the impact prison might have on his health.
Deborah Feyerick, CNN, Providence, Rhode Island.
(END VIDEOTAPE)
BROWN: We spoke early in the program about the decision to lead a country into war. We deal now with decisions on a scale much less grand, but no less consequential.
Taking a country to war means taking Salina, Kansas, or Greensburg, Pennsylvania, or Brentwood, Long Island. (BEGIN VIDEOTAPE)
CHRIS CHAMBERLIN, ENGLISH TEACHER, BRENTWOOD HIGH SCHOOL: We've lost three students in the war, two in Iraq and one in Afghanistan, one African-American, one Latino and one Caucasian. That's who we are. They are a slice of Brentwood.
BETTY BROWN-GREEN, DEAN, BRENTWOOD HIGH SCHOOL: Very big loss. In Brentwood, we are a family. And when something happens, we come together as a community. And you feel it. Whether it was Raheen Heighter, Michael Esposito, or Ramon Mateo, it's like losing one of our children. So it was very painful.
Raheen was ahead of his time. He was bright. He was intelligent. He was headstrong. Raheen was a go-getter.
SGT. ARTHUR BURGESS, BRENTWOOD HIGH SCHOOL ROTC PROGRAM: Michael was a, I would say a 110-pound kid soaking wet. He was very close to me. Occasionally, when I step out in the hall, I can still see a little, thin kid dressed in his camouflage BDU standing in the hallway saying, hey, Sarge. So he was one of the good ones.
LINDA PAPPERT, ASSISTANT PRINCIPAL, BRENTWOOD HIGH SCHOOL: And Ramon was the kind that he had this energy. He had this wonderful charisma, but he needed to know how to focus it. And he knew he needed the military to kind of grab it together for him. And he went.
And when he came back, he knew it. You could see he was happy. He was just very proud of himself. And there he was in his uniform, looking handsome.
THOMAS O'BRIEN, PRINCIPAL, BRENTWOOD HIGH SCHOOL: In each of these cases, we had an evening event here at the high school and presented a memorial plaque on behalf of the Brentwood School District. That's hung in our lobby. There are two now. The parents of Ramon still have his. We give them to them for a couple of weeks. And they bring them back and we mount them on the wall in our Wall of Honor outside.
It's a very working-class community, where about 62 percent of our families live below the federal poverty line. For either a two- year or a four-year college experience, many look to other avenues to finance that, one being, you know, veterans benefits.
CHAMBERLIN: since I was in the Marine Corps for four years, which helped me go college, I'm one of the people they come to discuss that as an avenue for their future.
He's someone alive from Brentwood serving in this war.
In a great irony, the publicity that all of this has received, I have even more students now that want to join.
ROBERT SMITH, BRENTWOOD HIGH SCHOOL JUNIOR: To see them just in their uniforms, proud, it affects me. It gives me this feeling that they died doing something great for us. RYAN RAMKISSOON, BRENTWOOD HIGH SCHOOL SENIOR: The military's always been a dream for me, just to defend my nation. If I die, well, I'll be remembered as a soldier, as a patriot.
CHAMBERLIN: All of these kids feel immortal. I think that's any kid anywhere at 18.
I'm an educator. Educate them as much as possible about the war, about politics, through literature. If anything was happen to them, would it kill me? Yes, absolutely. Yes, it's going to crush me.
PAPPERT: What I thought coming out of that assembly the other night, thinking, we're going to add another picture to that wall, and I was thinking, oh, God, I hope that never becomes full.
O'BRIEN: I feel very proud of the fact that they chose to put their lives at risk for what they believed was right and what they believed was good and, in fact, to put their lives on the line, so that others didn't have to. I hope that their sacrifice reaches the goals for which it was intended.
(END VIDEOTAPE)
(COMMERCIAL BREAK)
(ROOSTER CROWING)
BROWN: Okeydokey, time to check morning papers from around the country, around the world.
We'll begin, actually, with a tale of two headlines. "The International Herald Tribune," published by "The New York Times" in Paris. Over there, OK? "Elections in Iraq Now Seem in Doubt. Sunni Leaders, Iraqi Prime Minister Say Order Must Be Restored Before Ballot." OK, that's the headline there.
Now "The Washington Times" headline: "U.S. Declares Insurgency Broken. Military Also Says Bin Laden Is Cut Off." I hope "The Washington Times" is right. But I'm kind of worried that maybe the light is not at the end of the tunnel yet. Anyway, that's how they headline it. This is the story that I really look forward to reading most, though, "Spreading the Word on Farewell Tour, Billy Graham Returns to California." Dr. Graham is 86 years old now. And this is his last swing around the country. He's battled some health issues, but he's going to do it. And God bless him for it.
"Stars and Stripes." "Powell: Iran Fitting Missiles for Nukes" is their lead. Why did I like this? I don't know.
"The Philadelphia Inquirer" leads with Vioxx. "Two Vioxx Critics Allege Pressure." "Specter Wins Panel's Backing." Finally, we've hopefully seen the end now of the Arnold -- Arlen, not Arnold -- Arlen Specter story.
"Kmart May Lose Its Identity" the lead in "The Detroit News." For those who once worked at Kmart -- and I did -- attention, Kmart shoppers, in the next 10 minutes and 10 minutes only -- in Connellsville, Pennsylvania. Anyway, that's sort of sad.
The weather tomorrow in Chicago, by the way...
(CHIMES)
BROWN: How does that happen every night? "Bleak."
We'll wrap it up in a moment.
(COMMERCIAL BREAK)
BROWN: We're a little late tonight.
Good night for all of us at NEWSNIGHT.
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