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Unapproved Prescription Drugs Being Sold in Pharmacies?; Riding With Edwards

Aired September 27, 2007 - 15:00   ET

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

KYRA PHILLIPS, CNN ANCHOR: Well, your doctor may have prescribed it. Your druggist may have dispensed it. You might have taken it, and the FDA may never have approved it. You may be stunned by what our Gary Tuchman uncovered about you and your prescriptions.
DON LEMON, CNN ANCHOR: And, oh, boy, make way for Lorenzo. The world's newest tropical storm is in the storm-friendly waters of the southern Gulf of Mexico with the Mexican mainland in its sights.

Hello, everyone. I'm Don Lemon, live at the CNN world headquarters in Atlanta.

PHILLIPS: And I'm Kyra Phillips.

You're live in the CNN NEWSROOM.

Supporters of the Jena Six defendant Mychal Bell, well, have cause to celebrate today and not just his possible release from jail.

The latest now from CNN's Sean Callebs, who is just inside the Jena courtroom -- Sean.

SEAN CALLEBS, CNN CORRESPONDENT: Yes.

Within the last hour, the district attorney here, Reed Walters, who has really been front and center in the ongoing prosecution of Mychal Bell and the other members of the so-called Jena Six, said he will not challenge an appellate court decision and he will not try to retry Mychal Bell as an adult.

Instead, the DA says, after conferring with the family of Justin Barker, the white teen who was allegedly beaten by Bell and the other members of the Jena Six and by talking to other legal experts, he has decided to just pursue charges in the juvenile court. This is why the DA says that all this is very significant and how he came to his decision.

(BEGIN VIDEO CLIP)

REED WALTERS, LASALLE PARISH DISTRICT ATTORNEY: The only way -- let me stress that -- the only way that I believe that me or this community has been able to endure the trauma that has been thrust upon is through the prayers of the Christian people who have sent them up in this community.

(APPLAUSE) WALTERS: I firmly believe, and am confident of the fact that had it not been for the direct intervention of the lord Jesus Christ last Thursday, a disaster would have happened. You can quote me on that.

(END VIDEO CLIP)

CALLEBS: Well, that was the district attorney, Reed Walters, talking about what he believes has really kept this, in his words, this community together.

The police in this area and also what he said, that Jesus Christ -- he said that his presence could be felt among the 15,000 to 20,000 demonstrators who protested very peacefully here in Jena last Thursday.

Well, we got a chance to speak with a member of the African- American clergy here, who said that, in essence, that was an insult to many of the people that came out here and protested that day. And he believes, Don, that that is going to drive a further wedge in this community. Not only has it been divided racially, but now religion has been thrust into this.

LEMON: It's already a very incendiary topic for lack of a better term there and it just seems like he's fuelling the fire. One would think that he would not want to do that in this case, Sean. I'm sure that was surprising to people in the courtroom as well.

CALLEBS: It was.

But it was odd being in the courtroom, because you heard the applause when the DA started speaking. There were at least 50, maybe 75 supporters of the district attorney inside. And in essence, this was the DA coming out to make his case, where he's going to go from here and how he got to this point.

And this was an individual who has clearly dug his heels in all along. He makes no apologies for how he's gotten to this point and clearly plans on prosecuting Bell and the other members of the Jena Six to the best of his ability.

That said, we do know that Bell's legal team has been busy today. They filed two measures in the appellate court. Firstly, they're trying to get Bell released on a bond now that the DA's made it clear he's not going to pursue those charges in adult court.

And, secondly, if they're not able to get him released on bond or bail, then they want Bell moved from an adult facility where he has been kept for the past nine months, about 20 minutes from here, to a juvenile facility. We hope to know more about that shortly. We know the Reverend Al Sharpton, as well as Melissa Bell, Mychal Bell's mother, plan on coming to the courthouse in a little bit and holding a news conference themselves -- Don.

LEMON: All right, thank you very much, Sean Callebs. Thank you.

PHILLIPS: And to Illinois and a possible end for a search of a missing Chicago woman. Sources to say that they are close to the family and they tell a Chicago TV station that a body found near a suburban Chicago forest preserve this morning is Nailah Franklin, but police are not confirming that at this point.

(BEGIN VIDEO CLIP)

RUSSELL LARSON, CALUMET CITY POLICE CHIEF: At no time has anyone identified this body. OK? That's the first thing I need to tell you. And no one has indicated to anyone who this might be or might not be.

The only people that have been close to this deceased are police officers and they absolutely cannot make an identification. So, I want to make that clear. There are people walking through the crowd apparently purporting to be people that they are not, or they are confused.

However, this family that everybody anticipates, trying to be considerate of their feelings and their emotions, so try to keep all that in mind.

(END VIDEO CLIP)

PHILLIPS: The 28-year-old pharmaceutical sales rep was reported missing more than a week ago when she failed to show up for work. Police are saying only that the body was found unclothed and not far from Franklin's abandoned car. Police also have not named any suspects.

(WEATHER UPDATE)

PHILLIPS: Well, for the second straight day, government forces in Myanmar have opened fire on pro-democracy protesters led by Buddhist monks.

The bloodshed started when the military junta apparently lost patience with the protests and the unwanted attention from the outside world. State-run media reporting nine people killed. And, at the White House, President Bush issued a statement read by his spokeswoman.

(BEGIN VIDEO CLIP)

DANA PERINO, WHITE HOUSE PRESS SECRETARY: "I call on all nations that have influence with the regime to join us in supporting the aspirations of the Burmese people and to tell the Burmese junta to cease using force on its own people who are peacefully expressing their desire for change.

"By its own account, the junta has already killed at least nine non-violent demonstrators and many others who have been injured and arrested as they seek to express their views peacefully.

"I urge the Burmese soldiers and police not to use force on their fellow citizens. I call on those who embrace the values of human rights and freedom to support the legitimate demands of the Burmese people." (END VIDEO CLIP)

PHILLIPS: The United States is pressuring China to try to calm the situation. Beijing has ties to Myanmar's leaders.

And here are some photos from the streets of Yangon. They came in from a local blogger. The protests that started some 10 days ago had been peaceful until the military junta apparently lost patience. The protest started over a gas price hike, then took a new turn when the monks took the lead and joined the pro-democracy forces.

Even with the recent pushback, the junta's reaction is far more restrained the last time it faced this kind of challenge. In 1988, a violent crackdown is believed to have caused some 3,000 deaths.

LEMON: Who is watching the borders? Well, a new U.S. government says, far too often, nobody.

Federal investigators today released details of their successful attempts to cross into Canada on foot and unnoticed. U.S. agents even set up a sting, hoping they would be caught, smuggling fake radioactive material in large red bags into and out of Canada. They captured themselves in photos and video and are appearing in person before a Senate committee.

PHILLIPS: It's an emotional custody battle involving a Cuban father who wants to go home with his child. Sound familiar? No, it's not the Elian Gonzalez case, but there are similarities.

A Florida judge ruled that the father should get custody of his 5-year-old daughter, rejecting state arguments that he had abandoned her. The father won't gain custody immediately and a follow-up hearing is planned. The little girl lives with foster parents in Miami. And the state had argued that taking her away would traumatize her. The girl came to the U.S. with her mother who later became unable to care for her.

LEMON: Six Arkansas nuns accused by the Catholic Church of heresy have been excommunicated. Three of the six pictured here are biological sisters. The Diocese of Little Rock says the six refused to give up membership in a Canadian sect whose founder claims to be the reincarnation of the Virgin Mary.

Well, this is the first excommunication in the diocese in 165 years of history there.

(BEGIN VIDEO CLIP)

REV. J. GASTON HEBERT, DIOCESE OF LITTLE ROCK: Until you change that which is hurting our family and committing scandal, with these beliefs that are contrary to what we believe Jesus Christ taught, then you can't sit at the table with us.

(END VIDEO CLIP)

LEMON: The Arkansas nuns will be allowed to stay in their convent in Hot Springs, which they own. By the way, the Vatican has declared all members of the so-called Army of Mary excommunicated.

PHILLIPS: Police in Florida has arrested the drive-through customer that say is responsible for pepper-spraying workers in McDonald's.

The suspect, a 17-year-old male, allegedly was dressed as a female at the time of the attack; 12 employees had symptoms and the whole restaurant had to be evacuated. Four other passengers in the car are said to be cooperating with police.

LEMON: The numbers are going south, not exactly encouraging for would-be home sellers. The very latest on the slump straight ahead in the CNN NEWSROOM.

PHILLIPS: It can be found on many pharmacy shelves. Could they be hiding in your medicine cabinet, too, prescription drugs the government says has never been checked for safety? CNN investigates.

(COMMERCIAL BREAK)

LEMON: Thirteen past the hour. Three of the stories we're working on for you right here in the CNN NEWSROOM.

The prosecutor in the Jena Six case says he won't appeal a ruling that Mychal Bell can be tried in juvenile court. Bell is one of the six black teenagers arrested in the beating of a white classmate. He was tried and convicted as an adult, but a state appeals court ruled he should be tried as a juvenile instead.

Police aren't confirming a report that the body of a woman found in suburban Chicago today is 28-year-old Nailah Franklin. She was reported missing more than a week ago when she failed to show up for her job as a pharmaceutical sales rep.

And, in Washington, President Bush has signed a bill to make college educations more affordable. The new law boosts Pell Grants and cuts the interest rates on federally-backed student loans by half over the next four years.

PHILLIPS: Trying to sell your homes for months with nary a nibble? Well, you're not alone.

CNN personal finance editor Gerri Willis joins us now live from New York with the very latest on the housing woes.

And, Gerri, I have noticed it state by state when I travel, lots of for-sale sign.

GERRI WILLIS, CNN PERSONAL FINANCE EDITOR: You're so right, Kyra.

You know, there are several big reports out this week and they all signal nothing good for the housing market. First, the S&P/Case- Shiller home price index came out this week. It shows the worst drop in home prices in 16 years. The home price index was down in 15 of 20 cities surveyed for an overall drop of nearly 4 percent. Also, the monthly sales report was released by the National Association of Realtors. Existing home sales are also down about 4 percent. Those are the worst numbers in five years.

And the report on new home sales for August just came out today from the Commerce Department. It says new home sales are at a seven- year low, an 8.3 percent drop from July. The consumer confidence index is out. That's down nearly five points. And, as you know, consumer spending has been holding up the economy. It's a linchpin, but if consumers don't feel confident enough to spend, we could be in for even harder times.

So, bad news for the housing market and the economy this week.

PHILLIPS: So, when could it turn around? Could it turn around?

WILLIS: Well, interestingly, the S&P Index Committee chairman David Blitzer told me that we haven't seen the bottom yet in housing. He says these cycles tend to last a long time.

And, as an example, he said the previous boom and bust cycle that peaked in October 1989 didn't even hit its lowest point until the beginning of 1994. That's a four-and-a-half-year span from the peak to the trough. And, at that rate, our market wouldn't recover completely until 2009 or later.

PHILLIPS: Wow. So, it is even possible to sell now?

WILLIS: Well, if you're one of these markets that is experiencing the downturn, and you can wait to sell, wait to sell. That makes a lot of sense.

But a lot of people can't do that. That means they have to do what realtors say, which is pricing your home right. And that's realtor code for lower your price. You need to get the right price on your house or you're not going to move it. And you will simply delay the process of selling if you don't price it right, not great news, but it's the best advice for you right now -- Kyra.

PHILLIPS: Gerri Willis, thanks so much.

You can tune in for more of Gerri Willis' knowledge about buying, selling, and all things homeownership. He show, "OPEN HOUSE," is on Sunday -- or CNN, rather, Saturday mornings, 9:30 Eastern. It airs on CNN Headline News also every Saturday and Sunday at 3:30 p.m. Eastern.

LEMON: It's the stuff of fairy tales. And for the first time, first daughter Jenna Bush is talking about her high-altitude engagement. What does that mean, high altitude? It must have been way up somewhere on the ski slopes, or the Eiffel Tower. I don't know where it is.

Also, she has a comment about her predecessor in the White House. Uh-oh.

(COMMERCIAL BREAK) PHILLIPS: Well, it's a story that you have been clicking on to CNN.com all day.

We may not know if Jenna Bush will get married at the White House, but we do know more details from the bride-to-be about how her Republican honey proposed.

Jenna tell's ABC's Diane Sawyer that her boyfriend -- she hates the word fiance -- woke her up at 4:00 a.m. for a hike and popped the question as the sun rose over Cadillac Mountain in Maine.

She describes Henry Hager as outdoorsy and says that he wants to find a job where he can support the environment. Jenna is working at an elementary school as a teacher and has a new children's book out. When asked which presidential offspring that she would most like to emulate, Ms. Bush replied Chelsea Clinton, who she describes as beautiful, smart and articulate.

LEMON: That is so sweet.

(LAUGHTER)

PHILLIPS: He's a romantic. That old Henry is a true romantic.

LEMON: Sorry. I had to go there.

(BUSINESS REPORT)

PHILLIPS: Well, when we experience the tragic death of a loved one, many of us might feel A loss of life inside ourselves.

But today's CNN "Hero" came out swinging. And she's using her boxing talent to breathe life and future into her drug-ravaged Community.

Monica Lovato is today's CNN "Hero."

(BEGIN VIDEOTAPE)

UNIDENTIFIED FEMALE: All right, so let's start.

MONICA LOVATO, CNN HERO: Espanola is a small community, and the biggest thing out there, they always say, is the drugs and the overdoses and the poverty and all the bad things. That kind of reputation, it is negative and it hurts the kids, it hurts the kids to hear that and to think that that's all there is.

My name is Monica Lovato, and I started a boxing program last year at the city of Espanola so that the kids would have something to do and somewhere to go after school.

When I was younger, there wasn't much to do in Espanola. We just found somebody's house to hang out at and party. Leroy Quintana was my boyfriend throughout high school. After high school, he got into a car accident on his way home late at night and he was killed in the car accident. Leroy's death really, really took a toll on me. It felt like a part of me died. To try and get my mind off of things, forget about Leroy and forget about what happened, I started boxing. It's really changed my life around.

UNIDENTIFIED MALE: The winner and the new IBA Women's Welterweight Champion! Monica Lovato!

LOVATO: I just recently won the IBA Bantamweight World Champion title belt. Last year, I made an agreement with the city that I would volunteer my time to start the Espanola Boxing Club. It's something for the people, something for the community. The most important part of my program is teaching self-discipline and raising their self- esteem.

Those of you who have been slacking on running, you're only hurting yourself. Remember that, OK?

The dream is to build a big community center that's affordable for everybody. If we don't keep them busy and have something for them to do, well, then, we haven't accomplished anything.

I'm not just boxing in the ring, but I'm fighting for my community.

(END VIDEOTAPE)

PHILLIPS: And you can go to CNN.com/heroes to check out a day in the life of Monica Lovato and see footage of her recent fight for the world champion title belt.

While you're there, you can also nominate a hero you know, but you only have until Sunday to do so. Selected winners will be honored during a special live broadcast on December 6 hosted by our own Anderson Cooper.

LEMON: An infant dies after a treatment with unapproved drugs. Twenty years later, her mother can't believe unapproved drugs are still on the market.

(BEGIN VIDEO CLIP)

JACQUE GIBSON WHITE, MOTHER OF RACHEL ANN: I did not realize there were still drugs out there that weren't being monitored or approved. I don't even -- I still to this day do not understand how they get out there.

(END VIDEO CLIP)

LEMON: Not approved at the FDA, but sold at your pharmacy.

She's emerged as one of the most outspoken critics. So, what does John Edwards say about his wife's role in his campaign? Straight ahead, Edwards takes a ride on the Election Express, talks campaign strategy with own Candy Crowley.

(COMMERCIAL BREAK)

PHILLIPS: Democratic presidential hopeful John Edwards in New Hampshire today kicking off what he's calling his economic fairness tour. He joined our Candy Crowley on the "CNN Election Express" en route to a stop at the University of New Hampshire. Candy joins me now from Durham. Candy, Edwards was running a distant third in the latest New Hampshire poll, right? What's he doing to gain traction in that state and nationally?

CANDY CROWLEY, CNN CONGRESSIONAL CORRESPONDENT: Well, I'll tell you, it is very clear how John Edwards is going to be spending his fall and his winter. Winter, trying to make a difference between himself and Hillary Clinton. At the bottom line, he believes that democratic voters see the choice that the choice will be him. Now, this comes through in economic policy, in policy toward Iraq, in social security, all of these things Edwards wants to clearly say, here's what she believes, and here's what I believe.

Now, in this interview, we talked a little bit about that. And we also talked about other things. Whether he thought Barack Obama was experienced enough to be president, whether he thinks Hillary Clinton would be a drag on other democrats in the south or the Midwest. And we also talked about Mrs. Edwards who has, as you know, has been very critical of some of her husband's rivals.

(BEGIN VIDEO CLIP)

JOHN EDWARDS, (D) PRESIDENTIAL CANDIDATE: I embrace my wife speaking her mind. She's a strong woman. Got her own opinions. She doesn't and should not ask me whether she can express her opinion. I mean, I embrace her ability to do that and I applaud her for it. Does she say some things that are different than what I say? Yes, of course, we're two human beings, we're not the same person. There's nothing unexpected about that. So, no, I hope she'll keep speaking her mind.

CROWLEY: So you don't think it diminishes you in any way to have her out there pounding?

EDWARDS: No, I think she should be out there saying what she thinks. I think most of these things have arisen in the context of her being asked very specific questions. When she asked a very specific question, she has this really odd characteristic for somebody in politics, she actually answers the question.

(END OF VIDEO CLIP)

CROWLEY: On other news along the home front, J. Edwards they are of course home schooling their young children as they travel through New Hampshire and Iowa and elsewhere. Edwards said, in fact, this very morning before he took off, he was helping teach his children. He says it's going very well. As for Mrs. Edwards' health, he says so far she's showing no symptoms, that she feels very good, and he said, knock on wood, it's going well -- Kyra?

PHILLIPS: That's good news. I understand you're holding out on us here. There's some sort of breaking news development that we've got to save for the Blitzer man in "SITUATION ROOM." But can you give us any kind of insight, Candy?

CROWLEY: What can I tell you? You know between you and me I'd tell you, Kyra. But I can't. Listen, let's just say it's an interesting turn for John Edwards and he also issues a challenge to Hillary Clinton and to Barack Obama to follow suit. So, there's your hint.

PHILLIPS: Oh, OK. That's good. All right, 4:00 Eastern time, Candy Crowley, Wolf Blitzer and the scoop. Candy, always great to see you.

CROWLEY: Sure, thanks, Kyra.

PHILLIPS: You can see all the day's political news at any time, day or night, cnn.com/ticker. We're constantly updating it for you with the latest from the candidates on the campaign trail. You can always catch Candy Crowley's exclusive reports.

LEMON: All right, your doctor writes a prescription, your pharmacist fills it and you take it and probably never even considering the drug may not -- may not -- have FDA approval. But sometimes unbeknownst event to your pharmacist, that is the case.

Here's CNN's Gary Tuchman.

(BEGIN VIDEOTAPE)

GARY TUCHMAN, CNN CORRESPONDENT (voice-over): Jacque Gibson White had her first and only baby in February of 1984.

JACQUE GIBSON WHITE, INFANT DAUGHTER DIED: She was beautiful, of course. Perfect. In every way, except she was too little.

TUCHMAN: How much did she weigh?

WHITE: 1.15, 1 pound, 15 ounces.

TUCHMAN: Tiny Rachel Ann was born 14 weeks early. No one knew why. But doctors reassured the parents estimating she had an 85 percent chance of survival.

WHITE: Those are doll clothes, that is one of the garments she wore.

TUCHMAN: But Rachel got sicker. She was hooked up to machines. She turned blue. She had seizures and then in less than a month, she died.

WHITE: We did get to hold her before we left. And I can bring that memory up anytime I want. There were no tubes. There were no doctors. She wasn't blue. She was absolutely beautiful.

TUCHMAN: Jacque was told her daughter died of kidney and heart failure for unknown reasons. When they told you she had died, what went through your mind?

WHITE: Well, it was my fault, of course.

TUCHMAN: Why?

WHITE: Because she was early.

TUCHMAN: Why was it your fault?

WHITE: Because she was a preemie.

TUCHMAN: The guilt must have been amazing.

WHITE: It was -- it was -- it still is. I still have it.

TUCHMAN: She lived with her guilt for 13 years until she heard about a drug that had been used with her daughter, it's called e- ferol.

WHITE: I was told it was used to helped to correct blindness in preemie babies or prevent blindness.

TUCHMAN: Given intravenously, e-ferol had never been approved by the Food and Drug Administration.

WHITE: What I learned was that the e-ferol, she was given it every day she was in there, and that's what caused kidney failure and that's what ultimately is the reason she died.

TUCHMAN: The FDA says at least 37 more babies died from the blindness-prevention drug before it was taken off the market. The manufacturer settled more than 130 lawsuits including Jacque's. Several executives went to prison. But e-ferol was far from being the only unapproved prescription drug available back then. And even more incredibly, there are many available today.

DEBORAH AUTOR, FOOD AND DRUG ADMIN.: We estimate that as many as two percent of the drugs prescribed in this country lack required FDA approval.

TUCHMAN: Two percent, that means about 65 million prescriptions a year written to pharmacies all over the country for drugs never approved by the FDA. Many you've likely heard of, like the anti- seizure medication Phenobarbital. Even pharmacists are stunned. You prescribe Phenobarbital here?

UNIDENTIFIED MALE: Sure.

TUCHMAN: And did you know that the FDA has not approved Phenobarbital? Did you know it's an unapproved drug?

UNIDENTIFIED MALE: Unapproved? Since when?

TUCHMAN: In fact, one survey shows that more than nine out of 10 retail pharmacists have no idea they may be dispensing drugs that have not been approved by the FDA. And there's a good chance your doctor is also in the dark about some of those 65 million prescriptions. Just ask the American Medical Association.

DR. RONALD DAVIS, PRES., AMERICAN MEDICAL ASSN.: I think most doctors, maybe all doctors, just assume that if a medication is on the market, it's been approved by the FDA and it's been proven to be safe and effective.

TUCHMAN: E-ferol is one of several extreme examples of unapproved drugs. Keeping them honest, we asked the FDA how many more we should be worrying about. Are there dangerous drugs on the market today that aren't unapproved?

AUTOR: There may be some and we're working very hard to target those as quickly as we can to get them off the market.

TUCHMAN: When you say maybe, you're not sure?

AUTOR: There are some unapproved drugs on the market that pose risks, I do believe that.

TUCHMAN: But that just raises the question, why does the FDA allow unapproved drugs in your pharmacy in the first place?

AUTOR: It's not that simple to just sweep all these drugs off the market. For one thing, some of these products, not the majority of them, but some of them are medically necessary. There are a number of historical reasons why they're unapproved drugs on the market. There were successive changes in the law and some companies claim their products are grandfathered or don't require FDA approval.

TUCHMAN: The Feds have known about these unapproved drugs since the 1960s when the FDA was given enforcement power and was mandated to make sure that drugs were clinically tested and approved. Yet only now, more than 4 1/2 decades later, has the FDA started to crack down, eliminating drugs that says they're dangerous.

AUTOR: Last year we took action against Quinine, unapproved quinine containing products that had been linked to -- Quinine itself had been linked to 665 adverse events at least. That was just the number in our system, including over 90 deaths.

TUCHMAN: But this man thinks the crackdown is blown out of proportion.

UNIDENTIFIED MALE: At my peak, I was making 18 different products.

TUCHMAN: Muhammed Malik makes prescription drugs. He sold these seven drugs, mainly cold medications and antihistamines without FDA approval.

MUHAMMED MALIK, SYNTHO/INTERMAX PHARMACEUTICALS: Good drugs, of course, they are good drugs.

TUCHMAN: Safe drugs?

MALIK: Safe drugs. TUCHMAN: Approved drugs?

MALIK: They are not approved.

TUCHMAN: Malik makes his drugs in this factory in Long Island, New York and claims they're just as good as any others. The only difference he says is that he hasn't spent millions on the clinical trials required to show they work well and are safe.

MALIK: I'm a man of integrity, I'm morally obligated to give you a product which is good and which is exactly the way it says on the labels I have given them.

TUCHMAN: That might be true, but without FDA approval how can anyone know for sure that these unapproved drugs made by Malik or anyone else's unapproved drugs are safe? And how could the FDA allow unapproved drugs on your pharmacy shelves at all? Is anything being done about it? The answers when we come back.

(END OF VIDEOTAPE)

(COMMERCIAL BREAK)

PHILLIPS: E-ferol, Phenobarbital and chlorohydrate, they're just some of the drugs on your pharmacy shelves that don't have the Food and Drug Administration's seal of approval. What's being done about it? CNN's Gary Tuchman continues his investigation.

(BEGIN VIDEOTAPE)

TUCHMAN: Jacque White kept a diary during the 28 days of her infant daughter's life.

WHITE: Her kidney reads normal and the cultures came back negative, that's what's puzzling. I can't bear to write about the nightmarish events of the last 12 hours. Rachel Ann was born on a Wednesday and died on Tuesday, the first day of spring.

TUCHMAN: Jacque didn't find out why her daughter died until 13 years later. That's when she was told by a lawyer that the hospital had given e-ferol, an unapproved drug, that the FDA later recalled after 37 infants died.

WHITE: We will never forget our last moments with her. She was so peaceful and beautiful.

TUCHMAN: The FDA says two percent of all prescription drugs sold in the U.S. are for drugs that it has never approved. 65 million prescriptions a year. Did you know the drugs you were manufacturing, did you know they did not have FDA approval when you manufactured them?

MALIK: I didn't know that it did not require that due process of FDA approval, that I knew.

TUCHMAN: Yet Malik says he still sold his unapproved pills to pharmacies in major drug stores like K-Mart, Rite Aid, CVS.

MALIK: Pretty much all the major companies they would have it. Because I have a very good distribution system.

TUCHMAN: Walking through his factory, Malik tells us it's too expensive and too bureaucratic for small companies like his to go through clinical trials to get approval. And he's just fine with that. Can you understand how some people, when they find out, consumers, that their drugs aren't approved, they're pretty shocked about it?

MALIK: As a layman, I believe it still becomes the FDA's responsibility to let the consumers know that an unapproved product doesn't mean it is a bad product.

TUCHMAN: Yet Malik says he still sold his unapproved generic pills to pharmacies in major drugstores. The FDA went to court to stop Malik from selling these drugs. Dropping its lawsuit after he voluntarily recalled the drugs.

MALIK: I could have fought back with that, but it was not worth it.

TUCHMAN: So how could Malik have sold unapproved drugs at all? How could he get doctors to prescribe them and drugstores to stock them? In your opinion did the FDA know you were manufacturing these drugs?

MALIK: Absolutely.

TUCHMAN: Unapproved drugs?

MALIK: Unapproved drugs, absolutely.

TUCHMAN: Turns out it's the FDA itself that makes it possible for Malik and others to sell unapproved drugs and it still does, by giving them this little 10 digit number called the NDC number for National Drug Code. The FDA provides this number to any company that says it has a new drug. And here's the catch -- it provides the number to track them, before the drugs are approved.

AUTOR: An NDC number is not necessarily -- in fact, is not evidence that a drug is approved. We have granted NDC numbers to drugs regardless of whether they're approved.

TUCHMAN: And yet it's that number that lets pharmacies order those drugs, whether they receive FDA approval or not. Some congressmen are steamed about it.

REP. EDWARD MARKEY, (D) MASSACHUSETTS: There is a regulatory black hole that makes it possible for the pharmaceutical companies to be able to get the drugs to the stores that sell them without the FDA being able to monitor it.

TUCHMAN: Jacque White, the mother of Rachel Ann, says she can't believe this problem hasn't been fixed more than 20 years after her daughter died.

WHITE: I did not realize there were still drugs out there that weren't being monitored or approved. I don't even -- I still to this day do not understand how they get out there.

TUCHMAN: Now, finally, the FDA says it's cracking down. Issuing more warnings and even pulling drugs off the market. And now it's also considering changing the way it issues those 10 digit NDC numbers.

WHITE: It's possible that we will only give NDC numbers to approved drugs.

TUCHMAN: But Congressman Ed Markey says the FDA should do more than that and do it faster. For starters, he says, the FDA needs to come clean with a complete list of unapproved drugs.

MARKEY: In a modern era, in an internet era, it makes no sense that a list cannot be put together in order to determine whether or not a drug has been approved by the FDA.

TUCHMAN: Do you have a list of the 2 percent of drugs that are unapproved?

AUTOR: There's no one list of the 2 percent. We have a number of sources that we use to generate our understanding of the unapproved drugs that are out there.

TUCHMAN: Do you know what all the unapproved drugs are?

AUTOR: We pretty much know.

TUCHMAN: But for now the FDA won't release a complete list of unapproved drugs like these that Malik sold. It won't say how many people have been killed or hurt by unapproved drugs. It won't even say which unapproved drugs or how many of them have killed or injured people? Why? Partly because it doesn't want to stigmatize drugs that have a good track record. But what about all those unapproved drugs that may be dangerous or deadly? For now with the FDA still holding out, there is simply no way to know.

Gary Tuchman, CNN, Newport News, Virginia.

(END OF VIDEOTAPE)

PHILLIPS: Well, the FDA is set for a major overhaul. Just last week, Congress passed a bill that gives the FDA more power to oversee prescription drugs. President Bush is expected to sign it.

LEMON: And Kyra, we have some breaking news. New developments in the Mychal Bell trial. In the Mychal Bell case, I should say. Sean Callebs on the ground with the new information. What do you have?

SEAN CALLEBS, CNN CORRESPONDENT: Well it could be that Mychal Bell is released from lockup very soon. We know that right now the Reverend Al Sharpton, the bondsman that he uses is inside with Mychal Bell's mother and they are trying to work out the paperwork for a bond right now. Which means Bell could be freed very soon. We're told by Sharpton that bond is $45,000. Also another one of Mychal Bell's attorneys told us that Bell has been moved from the adult lockup at the La Salle Parish Correction facility to a juvenile facility.

Now, Sharpton tells us one of the items that they're still talking about now, would Mychal Bell be released directly from the juvenile facility or, Don, would he be brought back here to the La Salle Parish Courthouse and have paperwork done here and then be released through the lockup here. Those are the stumbling blocks right now. The Reverend Al Sharpton says once this is all worked out, he's going to come out and address the media to explain exactly how they got to this point.

LEMON: All right, Sean Callebs on top of it. CNN as well we'll continue to follow this story throughout our evening programming, prime time here on CNN. Thank you very much for that, Sean.

PHILLIPS: Straight ahead, the fishing boat found adrift off Florida, but where is the crew? That's the question. There's a story about pirates and murder but is anybody buying it? You'll know what we know when we're back in the NEWSROOM.

(COMMERCIAL BREAK)

PHILLIPS: Well, a bad story gets even more twisted every day. That boat on the right side of your screen is Joe Cool, found drifting between Florida and Cuba with signs that something went horribly wrong aboard. As we've been reporting in the NEWSROOM, two men hired the crew of this boat to take them to the Bahamas and a day later the men were found in a lifeboat. And according to court papers one is now telling a story of piracy and murder. No sign of the four-person crew. And these are the missing people. A husband and wife among them and their frantic relatives are hoping for the best and not buying the pirate story.

CNN's Nancy Grace spoke with one of them.

(BEGIN VIDEO CLIP)

VOICE OF JON BRANAM, MISSING BOATER'S COUSIN: We were just hoping and praying, you know, there is a chance that this story that this guy is saying, doesn't make sense. You know, these guys -- my whole family, my best friend, they're all missing, but they've been out in the water their whole lives. If anyone could survive it, it would be them.

(END OF VIDEO CLIP)

PHILLIPS: The boat's records reportedly show it making a turn towards Cuba before it started drifting. The man telling the pirate story is a Cuban national. The other one is wanted for theft in Arkansas. Both are in custody right now. Their bond hearing is set for tomorrow.

LEMON: Normally Noah's Arc Nursery and Preschool in Jefferson City, Tennessee, is filled with children, today it is closed and under investigation. Acting Tuesday on an anonymous tip, state inspectors say they found a 4-month-old old alone in a darkened bathroom with a pacifier taped to his mouth. They immediately called 911.

(BEGIN AUDIO CLIP)

LAURA FAIN, DHS: This is the evaluator that's with me went to the back to investigate a child had tape on its mouth with a pacifier shoved inside of it. She asked me if we removed it and I said no. Did you remove it?

LYNN FOX, DHS: No, they have now.

FAIN: They have now. So you saw it?

FOX: Oh, in the bathroom. I heard the baby crying.

FAIN: We're standing outside because we're a little upset.

911 OPERATOR: OK.

FAIN: And we're afraid we might say something that we might regret.

(END OF AUDIO CLIP)

LEMON: Police say one of the caregivers told them it had happened before. Calling it a mutual idea, between herself and another caregiver. No comment yet from the daycare owner.

Time now to check in with CNN's Wolf Blitzer.

PHILLIPS: He's standing by in "THE SITUATION ROOM" to tell us what's coming up at the top of the hour. We already know that Candy Crowley has some scoop for him regarding John Edwards.

WOLF BLITZER, CNN ANCHOR: She certainly does. We're going to have a lot more than that.

But getting back to John Edwards, he made a surprising announcement on board CNN's "Election Express." It's a decision that may shock some of his chief rivals maybe Hillary Clinton, Barack Obama, and one that some people feel could actually put the Democratic Party at a huge potential disadvantage. You're going to hear what John Edwards is saying. That's coming up in a few moments.

Also, health care for America's children. This hour the senate nears a key vote on an issue Democrats say that could haunt President Bush for the rest of his term. I'll be speaking live with the number two Republican in the U.S. Senate, Trent Lott.

And she may be risking her life by going back to her native Pakistan. The former Prime Minister Benazir Bhutto says she can help end radicalism there and she'll challenge President Pervez Musharraf. I'll speak one-on-one with Benazir Bhutto, that's coming up. A lot more, all that guys, right here in "THE SITUATION ROOM." LEMON: That sounds really interesting.

PHILLIPS: Yeah, I'll be staying tuned for that. She's a fascinating woman.

LEMON: Yeah, and John Edwards. Thanks.

PHILLIPS: All right, the closing bell.

LEMON: A wrap of all the action on Wall Street, straight ahead.

(COMMERCIAL BREAK)

PHILLIPS: Well, it doesn't get much bigger than this. A visit to the oval office. The national big brother and big sister of the year were honored today with a face-to-face meeting with President Bush. This year's winners, Charles Matthews of Louisville, Kentucky, and Crystal Rivera of Lorraine, Ohio. Big Brothers, Big Sisters is the oldest and biggest youth-mentoring organization in the country. It has 500 agencies nationwide. Matching mentors with kids, ages 5 to 18. And the organization says that kids in the program are 52 percent less likely to skip school, and 46 percent less likely to start using drugs.

LEMON: Great way to end the show, huh?

PHILLIPS: Absolutely.

LEMON: Congratulations to those guys.

PHILLIPS: Well, closing bell is about to ring on Wall Street.

LEMON: Hello, Susan Lisovicz. How are you doing?

SUSAN LISOVICZ, CNN CORRESPONDENT: I'm doing great, Don and Kyra. And so is Yale University. We're just going to say that the university is well endowed, if you will. Harvard University, its competitor, in the Ivy League, actually is a bigger endowment, but Yale University once again investing it better. It had an annual return of 28 percent, bringing its total endowment to $22.5 billion over the last 10 years. It has a nearly 18 percent return on its investments.

And, yes, it is the same person who has been managing it for more than a decade. The guy's name is -- I can't find it all of a sudden. But it doesn't matter. His strategy is this -- it's more -- it's diversification, more than stocks and bonds, hedge funds for some risks, but hard assets like real estate, oil, gas, timber, and he's done Yale very well.

LEMON: Yeah, it sounds like it and when it comes to endowment, size does matter. I mean, if you ...

LISOVICZ: And how you invest it.

LEMON: Yeah. LISOVICZ: And how you invest it. Now in terms of size on the stock market, well look at the Dow Industrials, less than a points now from 14,000 on a day when new home sales hit the lowest level in seven years. Home prices once again down. We had a major homebuilder, KB Homes reporting a quarterly loss, worse than expected. Saying the housing market could get worst next year.

But bad news on Main Street, some times good news on Wall Street and that investors, some of them think this will put more pressure on the fed to cut rates again. And we have a modest rally at the close. See you guys tomorrow.

LEMON: All right Susan. Time to turn it over now to "THE SITUATION ROOM" and Mr. Wolf Blitzer. Hi Wolf.

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