Merck, FDA Subject of Senate Scrutiny
BILL HEMMER, CNN ANCHOR: Carol Costello has graced our presence here in the studio in New York City.</s>CAROL COSTELLO, CNN ANCHOR: I like it when he says that.</s>HEMMER: What's going on? How are you? Good morning.</s>COSTELLO: What's going on? It's funny you should ask, because I have it right here.</s>HEMMER: Go for it.</s>COSTELLO: Good morning, everyone. Now the news, U.S. and Iraqi forces today discovered what appears to be a safehouse linked to terrorist Abu Musab Al Zarqawi. Military sources say they found two letters inside an empty house, one giving instructions to his lieutenants, the other asking for money and help. Symbols pledging loyalty to Osama bin Laden were also found in that house. Talks on free trade and global security are under way this hour in Chile. Top ministers from more than 20 countries including the U.S., arrived overnight for the APEC Summit. In the meantime, protesters are taking to the streets. There are reports of some clashes with police. About 120 protesters have reportedly been detain and released. President Bush is set to attend the summit this weekend. And new details the flu vaccine shortage to potentially have been avoided. An FDA report shows the agency knew about unsanitary conditions at a British flu vaccine plant last year. The plant wasn't reinspected until similar problems led to loss of half the U.S. supply of flu vaccine this year, but the acting FDA commissioner says there is no connection between the two. And it is a star-studded event in Little Rock, Arkansas. The dedication ceremony for the Clinton presidential center is set to get under way this morning. President Bush will be among the guests on hand for the festivities. The building opens to the public tomorrow and, of course, CNN will have live coverage of the library's dedication ceremony, and that begins at Noon Eastern Time -- 30,000 people expected.</s>HEMMER: Wow.</s>O'BRIEN: Bill Clinton knows how to throw a party.</s>HEMMER: Yes.</s>O'BRIEN: One-hundred and sixty-five million bucks, you can throw a nice party for that.</s>COSTELLO: Exactly, a lot of people donated a lot of money.</s>O'BRIEN: Exactly. Thank you. Well, Merck, the makers of the arthritis drug Vioxx and the FDA will be the subject of Senate scrutiny today. Just what led to the Vioxx recall, and was patient safety ever compromised? CNN's Chris Huntington is live on Capitol Hill this morning with a preview of today's committee hearing. Good morning, Chris.</s>CHRIS HUNTINGTON, CNN CORRESPONDENT: Soledad, good morning. Well, there have been serious concerns about the safety of Vioxx well before even the drug was launched, but senators want to find out today, is what did Merck and the FDA know about the dangers of Vioxx and when did they know it?</s>HUNTINGTON (voice-over): FDA scientist David Graham estimated in a study this summer that Vioxx caused nearly 28,000 severe heart attacks, many of them fatal, over a four-year period, but Graham tells CNN, and is expected to tell the Senate Finance Committee, that he was pressured to tone down those conclusions by the FDA. Committee chairman Chuck Grassley wants to know why Merck and the FDA didn't do more to protect the public from the dangers of Vioxx?</s>SEN. CHUCK GRASSLEY (R), IOWA: I'm very concerned about whether or not the Food and Drug Administration is doing the work they should be. The public is their clientele, and not the pharmaceutical companies.</s>HUNTINGTON: Grassley and other committee members will also grill Merck's CEO Ray Gilmartin, who is expected to continue defending his company and Vioxx.</s>RAY GILMARTIN, MERCK CEO: The FDA pointed out in their press release on the day we announced that we were voluntarily recalling the drug, that the risk for any one individual for a heart attack or stroke was very small.</s>HUNTINGTON: The FDA insists it did all it could on Vioxx and is sending the acting director of its Office of New Drugs to maintain that precision at the hearing. But Dr. Sidney Wolfe, whose worstpills.com Web site told patients to avoid Vioxx years ago, says the FDA and Merck did not warn more loudly on Vioxx because there was too much money at stake.</s>DR. SIDNEY WOLFE, PUBLIC CITIZEN HEALTH RESEARCH: The company didn't warn them, because they wanted to sell drugs, and the FDA didn't warn them because part of the problem for the FDA is they get paid directly by drug companies to do a lot of their business, and they don't want to offend drug companies.</s>HUNTINGTON: The FDA denied CNN's repeated request for interview regarding the money it receives from pharmaceutical companies. But since 1992, drugmakers have been legally required to pay the FDA to oversee new drugs and those already on the market. Vioxx plaintiff lawyers argue that was a conflict of interests.</s>ANDY BIRCHFIELD, VIOXX PLAINTIFF LAWYER: They were the lapdog for the industry and certainly not the watchdog for public safety that we need.</s>HUNTINGTON: Now, last night FDA acting commissioner Lester Crawford issued a lengthy statement, in part refuting the notion that FDA had ever suppressed any findings on Vioxx, and he went ton say that the FDA drug safety program is a system that is working -- Soledad.</s>O'BRIEN: Chris Huntington, on Capitol Hill for us this morning. Chris, thanks -- Bill.</s>HEMMER: Twenty minutes before the hour now. Changing the rules for Republicans in the house, and John Kerry's extra campaign cash. Left on the table, two good topics for a political jab this morning. We find Republican strategist Joe Watkins in Philadelphia this morning. Joe, good morning to you.</s>JOE WATKINS, REPUBLICAN STRATEGIST: Good morning, Bill.</s>HEMMER: Also former Hillary Clinton Press Secretary Lisa Caputo is in Little Rock today for the dedication of Bill Clinton's library. And, Lisa, welcome back, and good morning to you as well.</s>LISA CAPUTO, FMR. HILLARY CLINTON PRESS SECY.: Good morning, Bill.</s>HEMMER: Joe, I want to start with you. On the outside, Democrats are saying House Republicans are just trying to change the rules in midstream to protect one of their very own powerful members of the House. How can you refute that?</s>WATKINS: Well, I think it's pretty easy to do that. Now the rules on the Republican side look like the rules on the Democrat side. The Democrats, of course, have rules that don't force their leaders and top committee people to step down in the event of a felony indictment and now the Republicans have rules that say the same thing. And it means we won't be hijacked by any politically motivated D.A.'s that might want to hold the House leader, Republican House leaders, hostage.</s>HEMMER: Does this also indicate, Joe, that there will be an indictment handed down for Tom DeLay?</s>WATKINS: No, not necessarily at all, not necessarily at all. This is not to say that there will be an indictment, although some people associated with him have been indicted, but certainly this is a preemptive strike on the part of Republicans.</s>HEMMER: I want to get to Lisa on this. Republicans are saying this -- they're saying that this is a Democratic prosecutor back in the state of Texas who's out to get any Republican, be it Tom DeLay or anyone else. Your response to that issue?</s>CAPUTO: You know, we had seven years and $70 million with Ken Starr. It that wasn't a witch hunt, I don't know what was. Bill, this is a situation, though, if people want to make the comparison with the Clintons and the whole Whitewater investigation with the investigation of Tom Delay, people, three people around Tom Delay, have been indicted. Delay is under investigation for indictment. For the Republicans to change the rules just to take care of their own, I find quite amazing, particularly when Delay was pounding the gavel on the floor about, calling for Clinton to step down. I mean, this is -- it's hypocrisy at its finest.</s>HEMMER: Joe, what Lisa's saying is though that what goes around comes around. In this case it's coming back around?</s>WATKINS: Well, no, I don't think so. I think some Democrats would like for there to be payback, but clearly this is about making sure the rules are -- that there's parity in the rules. The Democrats, again, the Democrats' rules don't require their House leaders to step down in the event of a felony indictment, and now Republican rules say the same thing.</s>HEMMER: Well, but the Republicans changed the rules in midstream.</s>WATKINS: No, no, no, absolutely not. There's still going to be a 30-day review of those leaders. But what it means is that now that this Democratic D.A. down in Texas can't hold the House leader on the Republican side hostage.</s>CAPUTO: Yes, but, Joe, with all due respect, I mean, the rules weren't changed in the middle of the Whitewater investigation. Now that one of the Republicans...</s>HEMMER: Hang on, Joe. Lisa, finish your point; we're going to move on.</s>CAPUTO: All I'm saying, now that one of the Republicans own is coming under investigation and an indictment is feared. Now I don't see how that's right.</s>HEMMER: Next topic here. The story that was in "USA Today" yesterday, Lisa, that show John Kerry left $15 million on the table. It was not spent for the campaign. How did Democrats respond to that possibility, knowing that this election in many cases was extremely close? Maybe not for the White House, with 3.5 million votes going to George Bush, but some of these races in Democratic corners across the country?</s>CAPUTO: You know, it's interesting, Bill, this was quite the talk last night in Little Rock as people reception hopped and party hopped. I mean, I think, you know, a lot of people are questioning and -- whether or not John Kerry is going to seek the presidency again in four years. Certainly with cash on hand like that, it puts him in an enviable position to have a leg up certainly on the field. But don't forget, a lot of this chatter happened back in 2000 after Gore lost to the president, President Bush. And so, I think that it's fair to say there's a lot of questioning going on, it's early. But a lot of people are starting to speculate that indeed Kerry has an intention to run again in four years.</s>HEMMER: But should he give that money back? Donna Brazille, who may lead the DNC? We'll see what the leadership unfolds there for her. Should he give that money back or not, Lisa?</s>CAPUTO: You know, I think it's to be determined. Let's see, you know, how things shake down. I think there's probably an argument to give it back it to the Democratic National Committee. Certainly if it was raised through the committee, through that channel, there's certainly reason to believe that it should be given back to the party once there's a new chairman put in place.</s>HEMMER: All right, we got to run. Thanks, Lisa, Lisa Caputo there at the library in Little Rock and Joe Watkins in Philly. Thank you, Joe.</s>O'BRIEN: A children's watchdog group overseeing the design and safety of toys has released its annual list of the playthings that it calls the worst on the market. The group is called WATCH, which stands for World Against Toys Causing Harm. And WATCH says beware of the Happy Birthday Bear, the Fun Slides Carpet Skates, Imiginarium Police Car Building Blocks, The Megabuster Battle Weapon, the Dress Me Paz Penguin, and the Parents Magazine Mirror Pound-A-Ball. The list also includes the Pocket Rocket Miniature Motorcycle, Air Burst Rockets, the 38-inch Playtime Trampoline, and the Uzi-1 Commando Machine Gun. The toy industry, though, shot back by saying this -- quote: "Toys produced and sold in the U.S. are the most highly regulated and monitored in the world. The U.S. toy safety standards serve as a model around the globe." So a little bit of a fight going on there.</s>HEMMER: Get a break here. In a moment, Andy's "Minding Your Business." He's got the car of the year. I'll talk about it after this.</s>O'BRIEN: Also this morning, Condoleezza Rice is having surgery tomorrow for the most common form of tumors in women. The problem is, for lots of women, they don't even know they have it. We're going to "Page Dr. Gupta" to learn about the symptoms, just ahead on AMERICAN MORNING.