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European Regulators Take Avandia off the Market; Commonwealth Games in Jeopardy

Aired September 23, 2010 - 14:00:00   ET



Tonight a controversial diabetes drug is coming off the shelves in Europe. Regulators say Avandia, once a top-selling treatment raises the risk of heart failure. It will still be available in the U.S., but only as a last resort. And a few hours ago regulators on both side of the Atlantic made an unusual coordinated announcement. Doctor Pim Kon is the chief medical officer at GlaxoSmithKline, the makers of Avandia. I spoke to her just a short while ago.


DR. PIM KON, GLAXOSMITHKLINE: Well, we do believe that if you take the totality of the data and specifically with big clinical trials, the data do show that, you know, the benefit is still very positive and if used appropriately Avandia is, you know, safe and effective. Because after all you have got to understand that diabetes is a serious condition. And Avandia is very effective in maintaining long-term blood-sugar control.

However, having said all of that, you know, we do respect the decision of the regulating authorities. And, you know, we are working very hard with them to make sure that we implement any actions that are necessary.

FOSTER: The concern is that perhaps GlaxoSmithKline was hiding data or sitting on data which experts could have looked at and made judgments which are different from GlaxoSmithKline. And they could have made those judgments earlier?

DR. PIM KON: That is absolutely not true. You know, we have been working with the regulatory authorities for a long time now. That means we shared the data with them.

FOSTER: Yes, but they weren't allowed all the data straight away, were they?

DR. PIM KON: The regulatory authorities have always had access to the data. Once a product is actually marketed, we monitor the side affects all the time. And we share the data with regulatory authorities. They also have access to the data, too.

So, for example, if you were to have an adverse event with any particular product, you would tell your doctor. Your doctor would tell us. And we would immediately inform the regulators. So they would have had real-time access to data on any drug. So, we have been in communication with them ever since the product has been licensed. And they have been analyzing the data over this period of time.

And you know, the data are very complex and you know, that is why it has taken them a while to sort of decide what it is that they wish to do. And now that they have made the decision, we will totally abide by that. We respect that. And you know, in fact, I just come off the phone from the MHRA and to try and discuss what we should do in the best interest of patients and healthcare professionals.

FOSTER: What is the advice that you are now giving to patients and to doctors?

DR. PIM KON: Oh, well, the advice we're giving to doctors, obviously, is that they should no longer prescribe Avandia for any patients. And they should try and make appointments to see their patients as soon as they can in order to find alternative treatments for them.

And the advice to patients, you know, as a doctor I would really ask them not to make any rash decisions. They should continue to take their drug because obviously they need to keep their blood sugar under control. But at the same time they should make an appointment to see their doctor as soon as they can so alternatives can be discussed and they can then be transitioned onto other treatments.

FOSTER: Because a lot of people will be panicking, won't they? Because this is one of the best-selling drugs, has been one of the best- selling drugs in this area. They are going to be panicking about what this means and whether or not they have done any harm to themselves up to this point. Can you reassure people?

DR. PIM KON: I have very-a lot of sympathy for patients who are on Avandia at the moment. It must be very confusing for them. And it must be very distressing for them. What I can reassure them is that at the moment they should continue to take the drug. And discuss it with their doctor at the earliest opportunity.

FOSTER: OK, in terms of the information sharing. This all started, really, when you published all your data and independent experts, in America initially, went over that data and came up with a different conclusion from the conclusion that you've come up with. And the regulators have fallen on the side of those saying that actually there are- that the risks outweigh the benefits of this drug. Shouldn't you have just given that information out to everyone freely, early on?

DR. PIM KON: You know the data on Avandia are really complex. And the regulators have very, very eminent scientific faculty who actually work for them. And, you know, their interests is the safety of patients, too. So you know the data, as you quite rightly said, is in the public domain. We have made that available. We are very transparent with our data. And the regulators have taken the time to really analyze this. We have really rigorous scientific debate and they have come to their decision. So, you know, we will abide by that. And we will do everything we can to make sure that, you know, the actions are actually implemented.


FOSTER: Well, that's the view then, of the GlaxoSmithKline. Cathy Moulton is a clinical advisor at Diabetes U.K., she joins me now.

And you have been dealing with this for years, haven't you? Because there have been concerns about this drug. Just describe what people suffer as a side affect?

CATHY MOULTON, CLINICAL ADVISER, DIABETES U.K.: Well, Avandia has been on the market since about 2000. And it was known then that it had a side affect of causing heart failure. And the symptoms of heart failure would be swollen ankles and breathlessness. So, it was fairly straightforward to say to people, if you have any of these symptoms, go and see your doctor.

FOSTER: Were patients told that there was this risk of heart failure?

MOULTON: They should be. Because whenever-there are side affects with every medicine that you take, whether you buy it over the counter-

FOSTER: This is kind of a major one.

MOULTON: It is, yes. But as Doctor Kon was saying, you have to weigh the benefits against the risks. And the risk of uncontrolled high blood glucose levels are-could be heart attacks and strokes and so on. So the clinician would be working with the person and if the doctor didn't think that there was a risk of heart failure, then they would be prescribed this. It wasn't a first line treatment. People with type 2 diabetes tend to try to control their blood glucose levels with diet and physical activity, first of all. And if that doesn't work, then they are started on a very tried and tested medication. And then if that doesn't work other drugs are added in, a second or third line treatment.

FOSTER: And since this one was launched other drugs have come onto the market, anyway. So are you confident that diabetes sufferers will still have treatments available to them, once they are current run, effectively, of Avandia has run out?

MOULTON: That is right, yes. So, it might be that it takes a little while for their doctor and the person themselves to find one that suits them. But we hope that the people who are experiencing these adverse side affects have already gone to their doctor, and are already being transferred to something else. Those who are comfortable on it are going to have quite a difficult time, because they are going to be-their expectations will be quite high to get the same effect from a different group of tablets. But there are a number of different families of tablets all working to bring the blood-glucose level down.

FOSTER: Cathy Moulton, thank you very much indeed.

MOULTON: Thank you.

FOSTER: Now the 2010 Commonwealth Games were intended to showcase India as an emerging economic powerhouse. But with just 10 days to go, the games may actually show a very different picture of the country. Can Indian leaders make things right before the competition begins? We'll be taking closer look at that.


FOSTER: There is a crisis meeting in India tonight, as the Indian government fights to keep the Commonwealth Games up and running. With little more than a week to go before the opening ceremony some teams still haven't confirmed that they are actually going even. Mallika Kapur has more on the organizers last-minute race to the finishing line.


MALLIKA KAPUR, CNN CORRESPONDENT: The Indian prime minister has stepped in and tonight he is meeting with the Indian sports minister and also the minister for urban development to see how they can fix things and how they can speed up preparations for the start of the Commonwealth Games. There are only 10 days to go and there is a lot of work to be done before the games start.

Just in the last two days we have seen an overhead bridge collapse. We have seen parts of a false ceiling fall down. And there are several accusations that the living conditions at the village are just unhygienic, not livable, that the place is dirty. So the Indians do have a lot of work ahead of them. And that is why the prime minister has stepped in and see how he can prevent the preparations of the games from becoming even more of an embarrassment for India.

Meantime, there is, of course, has caused a lot of concern amongst international athletes and some of them have decided not to come here at all. Today we have had word from two Canadian archers that they have decided to pull out of the games. And several top teams, including New Zealand, Scotland, and Canada have decided to delay their arrival into India.

This has cause a lot of embarrassment amongst Indians. There are people who are upset at what this is doing to India's reputation on the international stage. There are people who are also very angry. Angry with Indian officials, because one Indian official said, when he was defending accusations about the village being dirty, he said, well, perhaps these people have a different level, a different standard of hygiene than Indians do. And that immediately got the Indians worked up. They said, wait a minute, is he trying to imply that we have a different standard of cleanliness? That we are dirty in any way? So Indians are very upset about that comment by an Indian official.

At the same time there is some support, as well, and Indians are saying, you know, what? This is the first time India is hosting the Commonwealth Games and all we need to do is give our country some support. Mallika Kapur, CNN, Mumbai.


FOSTER: Amit Mitra is secretary general of the Federation of Indian Chambers of Commerce and Industry. According to him that the business industry is trying to pull away now from what is being seen as such a disorganized event.

AMIT MITRA, SEC. GENERAL, FEDERATION OF INDIAN CHAMBERS OF COMMERCE: It is, of course, a great disquiet. But we also need to remember that at the end of the day India is growing at 8.8 percent. It has the SENSEX has reached 20,000. So when you are looking at a U.K. or a U.S. investor, he is going to look at those fundamentals of India, will feel terrible and miffed and I am. And angry and outraged by what I see on television, but that feeling miffed or the perception will be counterbalanced by the fundamentals of India, which are very strong.

FOSTER: You are not concerned that perhaps India's getting a reputation from this for bad management?

MITRA: I agree with you that there is a-this is a government, by and large, a government managed game. It contrasts with China immediately appears in your mind. But the point is that having said so, we have many examples of terrific successes in India, which we can (UNINTELLIGIBLE) with relating to Commonwealth Games. The airport, I have given you and example, Metro, I given you and example. So we need to understand, I would like to see the corruption or whatever happened, people be brought to books. And I assure you after the games are over our media is not going to let go.

FOSTER: Yes, you must be very angry with the organizers of this event for embarrassing India?

MITRA: Yes, absolutely. Anything that has been shown on BBC, CNN, in particular, which I have seen myself, makes our system into a-gets us into a rage for what we are seeing on television. I must add to that, that the games will be for the next 15 days. But let's remember for the international audience, that India is today the fourth largest economy, moving to third. Government organization has been an issue in India, in terms of governance. Project management, it is exposed a terrible project management capability. So what we would like to see as correction coming out of this.

FOSTER: Do you think it is better that the games maybe are canceled?

MITRA: I don't think so because we took a view of the stadia that had been built, some of them absolutely world class. Today the member of parliament from the area where the games village has been built, was there all day and told me in the afternoon that he is gone to 220 apartments and housing keeping was horrible. They were as you have shown yourself. And they are being cleaned out. And he said, what we have done in 16 days they could not have done in three months, which shows that determined effort can clean this up. And hopefully the games won't get canceled. But if it is, we will feel even worse than what we are feeling today in terms of the mess ups.

FOSTER: We'll see what happens in the next few days. We may well sort it out of course.

Well, the main event is already underway at the United Nations. It is a skills game of diplomacy involving every top national team in the world, including yours. Here is one of the top players at work. We'll have a ringside seat.


FOSTER: The world economy is in focus at the 65th session of the United Nations General Assembly in New York. Exchange rates remain a hot topic between the U.S. and China. Premier Wen Jiabao is rejecting claims the Chinese currency is undervalued. China is also under pressure to resolve its spat with Japan. Asia's two largest economies are at odds over Japan's detention of a Chinese fishing boat captain. Beijing has even gone as far as blocking key exports to Japan. No meetings are planned between the two of them as yet.

The fight against global poverty is also a concern. The U.N. chief made official a new $40 billion health initiative for women and children. Let's cross live now to New York. CNN's Richard Roth is at the United Nations and he joins me now-Richard

RICHARD ROTH, CNN SR. U.N. CORRESPONDENT: Max, there are many one on ones between heads of state world leaders here, but probably one of the most significant, if not the most significant is was a one on one between the Chinese premier and the U.S. president.

Now, President Obama is well aware that there is considerable anger in the United States regarding the Chinese currency and that some consider, here, its value too low, its value, since it has been pegged to the dollar. The U.S. president, publicly, at the United Nations, said with the Chinese leader in his presence, that he is very pleased with the level of cooperation on a lot of issues so far with the Chinese government.


BARACK OBAMA, PRESIDENT OF THE UNITED STATES: I have great confidence in the interests of both President Hu and Premier Wen, to continue on the path of cooperation and mutually beneficial policies. I look forward to seeing them at the G20 and APEX, this fall. And I am looking forward, mostly, to the possibility of President Hu visiting us for an official state visit, sometime in the near future.


ROTH: The Chinese leader made a speech a short time ago at the U.N. General Assembly. There was no major points made of any controversy, certainly, regarding currency rates. It was last evening in New York that the Chinese leader was rather forceful in defending his country against criticism regarding the currency. At the U.N., today, with President Obama, again, he was diplomatic.


WEN JIABAO, CHINESE PREMIER (through translator): We have cooperation on targeting the financial crisis and meeting the climate challenge. China and the United States can also embrace even closer and bigger and relationships in the field of public finance, financial industries, and economic cooperation and trade.

I have come to this meeting with President Obama with a candid and constructive attitude.


ROTH: The United States has more than $145-billion trade deficit in the first seven months of this year, with China. Last evening the Chinese premier said the trade deficit was caused more by the structure of Sino- U.S. investments and trade, not the level of China's currency. Max, back to you.

FOSTER: Richard at the United Nations. Thank you very much indeed.

We head now a couple of miles down the road to Wall Street, where stocks are wavering on a mixed batch of economic news. Alison Kosik is standing by at the New York Stock Exchange.

Alison, first of all, take us through those jobless claims figures. They were interesting.

ALISON KOSIK, CNN FINANCIAL CORRESPONDENT: Yes, exactly. You know, it seems like it is one step forward, two steps back with these reports lately. We found out that weekly jobless claims increased by 12,000 last week to 465, 000. And that is more than analysts had expected. And it really was the first jump in three weeks for the reading. You know, jobless claims have really been one of the most stubborn parts of the recovery. They have been basically stuck in the same mid-400,000s range since last November. And analysts really want them a whole lot lower than that.

Unemployment numbers, overall, have become one of the defining measures of the economic recovery. And without improvement in the labor market, Max, many economists really feel that a true rebound is still a ways off, Max.

FOSTER: And in terms of home sales, that is the other thing that people have been looking at. Does that tell a similar story?

KOSIK: Actually a better story with home-with these home numbers. Sales did come in, in line with what analysts had expected. We found out that existing home sales rose just over 7.5 percent in August. It is a recovery from July when sales had plummeted more than 25 percent and it was a major factor that helped stocks rebound after, you know, being down so much on the jobs figures that I just talked about. You know, but still, Max, investors aren't overly impressed. In this current market environment they really want to see more robust sales. That signal that a recovery in the housing market is really happening, before they actually buy into the market, Max.

FOSTER: Alison at the stock exchange, thank you very much, indeed.

KOSIK: Sure.

FOSTER: Trains delayed and plane grounded, strikes over pension reform hits France for the second time this month. We'll have the latest from Paris.


FOSTER: Welcome back.

I'm Max Foster in London.

More QUEST MEANS BUSINESS in just a moment.

But first, here are the main news headlines.

U.S. President Barack Obama says if Middle East peace talks fail, Palestinians will never have a state and Israelis will never know security. The remark came in his address to the U.N. General Assembly. Mr. Obama emphasized the talks, but he touched on a number of other issues, as well as -- as well, including Iran, Iraq, Afghanistan and the U.S. economy.

Well, the top leaders of the Colombian guerrilla group, FARC, have been killed in a bombing raid. Colombian president, Juan Manuel Santos, says the death of the FARC's number two man, known as Mono Jojoy, is a, quote, "historic event." The FARC has been at war with the Colombian government for more than 40 years.

India's government has reportedly set deadlines for organizers to complete remaining work on the upcoming Commonwealth Games. The international sporting event has been plagued with problems involving security, hygiene and construction. New Zealand and Canada are the latest members to delay their delegates' departure for the games. Scotland did the same earlier this week.

A scathing new United Nations report is blasting Israeli for its raid on a humanitarian aid flotilla in May. Nine Turkish achieves were killed when Israeli troops stormed the flotilla bound for Gaza. The U.N. Human Rights Council says Israeli committed serious violations of international law. Israel is rejecting the report as biased and one-sided.

Meanwhile, austerity is in full view over in France, where trade unions have staged a second 24 hour strike in a month.

Jim Bittermann, CNN's senior international correspondent, joins us from Paris, where he's been braving today's transport chaos.


JIM BITTERMANN, CNN CORRESPONDENT: Massive demonstrations in more than 100 cities and towns across France today.

But the big question is whether today's demonstrations are going to be bigger, the same size or smaller than what took place here at the beginning of the month, when something like three million people turned out in the streets, according to the unions. Basically, if they can turn out more people today, they're going to -- the unions are going to say that they won in this face-off with the government over pension reform. If they can't do that, then the government is going to say that it won.

But no matter who wins on the demonstration front and on the streets, the real losers were the commuters -- the people who had to use public transportation today, as the transportation system was crippled by today's strike.


UNIDENTIFIED MALE: We had a Ryanair flight which was canceled two nights ago because of the expected air traffic controllers strike. So we had to rebook that. And then we've been trying to figure out here what's going on and it's been tough.

UNIDENTIFIED FEMALE: Oh my god, it's packed. It is so packed it's unbelievable. You can't breathe in the train, believe me.

UNIDENTIFIED FEMALE (through translator): I cannot tell you, it's ridiculous. It's really ridiculous. This morning, it was impossible to get on the train. We were like sardines, you know?


BITTERMANN: In fact, all the unions can really hope for are a few minor concessions on the margins here. The government has made it clear it's going to raise the retirement age from 60 to 62. They might make some exceptions for some work groups or people who have exceptionally difficult jobs. But for the most part, the government has made it absolutely clear they're going to push ahead with raising the retirement age by two years.

Jim Bittermann, CNN, Paris.


FOSTER: Now, European stocks fell back after the region's services and manufacturing industries weakened more than forecast in September. But there were also renewed concerns that some European countries may struggle to repay their sovereign debt. In the meantime, data out today revealed that Ireland could be close to falling back into a recession. Official figures showed its economy shrank an unexpected 1.2 percent in the second quarter. That followed growth of 2.2 percent in the first quarter, when Ireland exited a very sharp recession.

Now, as the battle over the Arctic's resources threatens to drag on, Britain takes a different approach. In order to meet its commitment to boost renewable energy, the U.K. is turning increasingly to wind power.


FOSTER: Now, Vladimir Putin is calling for calm in the race for the Arctic's vast untapped resources that we were talking about on the program last night. The Russian prime minister spoke to an international conference on the Arctic in Moscow. He told delegates that the only way to deal with rival territorial claims is through negotiations, in compliance with international law.

Matthew Chance tells us what's at stake.


MATTHEW CHANCE, SENIOR INTERNATIONAL CORRESPONDENT (voice-over): It's being called the race for the Arctic. Russia ,with its fleet of nuclear- powered ice breakers, is looking to win it. Beneath this polar ice cap, now melting, scientists say, due to global warming, could lie up to one quarter of the world's gas and oil. And, of course, the country best positioned to exploit it could forge a powerful future.

VLADIMIR PUTIN, RUSSIAN PRIME MINISTER (through translator): A huge part of Russia's territory lie in the utmost north. Moreover, Russia generally is a Nordic country. Seventy percent of our territory is situated in the north. The very history and geography of our people have set forth a task of developing this land.

CHANCE: But other countries are also scrambling to stake their claims -- Canada, Norway, Denmark and the United States all have Arctic coastlines and are demanding a share of the region's potential wealth.

(on camera): It's not that often that such a strategic and valuable chunk of the planet comes up for grabs, so it's hardly surprising that tensions between the various Arctic states have been rising. But, of course, Russia has been energetically backing up its own position, patrolling the air and seas over the Arctic and spending tens of millions of dollars gathering evidence of its territorial claims.

(voice-over): Three years ago, Russia sent a submarine to the Arctic floor to plant a flag in a contested region amid protests from Canada and the U.S., Moscow says the Lomonosov Ridge, a range of underwater mountains rich in minerals, is an extension of the Siberian Continental Shelf and therefore Russian. So as well as vast resources in the Arctic, there's clearly also enormous potential for conflict -- something Moscow is eager to downplay.

PUTIN (through translator): Unfortunately, we sometimes encounter futuristic forecasts of an imminent battle for the Arctic. We clearly see that the majority of such scary scenarios regarding the Arctic do not have any ground. They are designed to promote clashes between the countries of the region.

CHANCE: The hope is that as the Arctic opens up and its riches are unleashed, nations can focus on the benefits of working together and avoid breaking this fragile environment apart.

Matthew Chance, CNN, Moscow.


FOSTER: Now, Britain is taking a major step in reducing its reliance on non-renewable energy sources. Today, the world's largest offshore wind farm was opened off Southeast England. And according to the industry association for wind and marine renewables, Britain's offshore wind capacity has now leap-frogged the rest of the world combined.

CNN's Jim Boulden went to investigate.


OYSTEIN LOSETH, CEO, VATTENFALL: I hereby declare Thanet Wind Farms are open.

JIM BOULDEN, CNN CORRESPONDENT (voice-over): Luckily, it was windy 11 kilometers off England's Kent Coast Thursday, where people celebrated the opening of the world's largest offshore wind farm. Thanet can generate enough energy for some 200,000 homes. The government says wind now provides the U.K. with 4 percent of its electricity.

All this comes at a cost. More than an estimated $1.5 billion to install the 100 turbines, some of that coming from the subsidies Britain is lavishing on companies to beef up the country's renewable portfolio.

CHRIS HUHNE, BRITISH ENERGY SECRETARY: It's not only in the U.K., but a large part of our investments, if in the U.K., will be in the U.K.

BOULDEN (on camera): Are you worried that subsidies are going to be cut in this era of austerity?

HUHNE: I don't think subsidies will be cut. But I think it's an important area for -- for the politicians in -- in every country, to meet their targets for -- for 2020.

BOULDEN (voice-over): Britain's energy secretary freely admits Britain lags far behind most of Europe when it comes to renewable energy.

HUHNE: We need a lot more prime renewables, because, as you can see today, there's one thing we've got a lot of in this country. We may not have a lot of sunshine, but we sure have got a lot of wind.

BOULDEN (on camera): And right now, a lot of subsidies, though. And you're not -- you -- you're not able to say that they won't cut some of the subsidies in the next budget?

HUHNE: Well, the key thing, obviously, with subsidies, the -- the economic reason for giving subsidies and the only legitimate economic reason for giving subsidies is to bring an infant industry up to the scale where it can wash its own face and it can compete commercially. And that's what we're doing.

BOULDEN (on camera): But Thanet is unlikely to stay the world's largest offshore wind farm for long. There are plans for a much bigger one just a few kilometers north from here. It could be three times this size.

(voice-over): And the industry is planning to use much bigger turbines in the next generation offshore wind farms. But with so many farms planned, demand is actually pushing offshore build costs higher. Vestas made the turbines used in Thanet.

ANDERS SOE-JANSEN, VESTAS: We have seen a rise in costs on the construction side. Yes, it has been going up. Going forward, I do expect what we call the cost of energy or life starting costs, to come down. It will come down over time.

BOULDEN: One thing that may help bring down costs -- more ports in the region, like Belgium's Oostende, are upgrading in order to handle the massive turbines and relieve the bottlenecks.

PAUL GERARD, PORT OF OOSTENDE: Well, there will just be a few ports that have the possibility and the space to invest in it. And I think they all should do, because what we see here is an -- an industry developing beyond comprehension, almost. We are going to build 10,000 windmills in this area only.

BOULDEN: That is, if governments continue to subsidize renewables.

Jim Boulden, CNN, Off Kent, England.


FOSTER: Some breaking news for you. The chief executive of HSBC is poised to step down, according to a report in "The Financial Times." The paper says Michael Geoghegan could leave the bank by the end of the year. It follows the resignation of the chairman, Stephen Green, who's joining the U.K. government as a -- as a trade minister.

Oh, to be a fly on the wall in that boardroom.

In a moment, the search engine that lost 90,000 people for a month -- how Google made the sun set on a town called Sunrise.


FOSTER: Returning now to our top story, a huge setback for GlaxoSmithKline. The sale of its blockbusters diabetes drug, Avandia, is severely restricted.

Margaret Hamburg is commissioner of the U.S. Food and Drug Administration.

She joins me now from Washington.

Thank you so much for joining us.

You're not going as far as the Europeans, who are effectively banning the sale of this drug, but you are restricting it.

MARGARET HAMBURG, COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION: We are. You know, we have looked very closely at -- at the scientific data and the risks involved. We agree with the EMA about the concerns for patient safety. But we're addressing the need to protect patients in a somewhat different way, using different regulatory tools that are available to us.

We're putting significant restrictions on use. We are requiring physicians to really examine whether this drug is indicated in their patients, discuss it with their patients. Patients have to attest that they understand the risks. Doctors have to document it in the charts. And then, for that limited set of patients for which Avandia remains the appropriate drug, it will be available for their use.

FOSTER: If I can break this down, is your suggestion that the risk of heart failure is too great, really, for this drug -- the balance was wrong before?

HAMBURG: Well, we're really talking about what we call acute ischemic events, or heart attacks, here -- increased cardiovascular risks for heart attacks, which was raised first back in 2007 when an important study was done and then additional studies have continued to examine that concern.

And there are debates about the data. And the cardiovascular risk profile remains somewhat uncertain. But -- but there are real reasons for concern and there are not any evidence to dispute that there are no cardiovascular risks.

The other drug in the category, Actos, does not have those cardiovascular risks based on studies. And so for most patients, Actos is the safer, more appropriate choice.

FOSTER: You refer there to that 2007 study. That was done by an expert outside your organization and outside GlaxoSmithKline, when the information -- the data became available to him. That data has always been available to you.

Why weren't you onto this before he discovered it?

HAMBURG: Well, I think that, you know, what he did, based on concerns that he had, was to look at -- at a whole set of studies that weren't actually designed to address this question of is there an increased cardiovascular risk, but did it in a way, through a technique called meta- analysis, to try to tease out that question.

It was an important study which we took very seriously. And we have subsequently done our own studies and also sought information from other sources and continued to look at that body of data so that we could appropriately weigh the risks and benefits to patients in order to provide the support for the best possible clinical care and patient safety.

FOSTER: Margaret Hamburg of the FDA.

We appreciate your time.

Thank you very much, indeed, for joining us on the program.

HAMBURG: Certainly.

FOSTER: Now, the city of Sunrise, Florida is back on the map -- on Google Maps, at least, that is. The home of 90,000 people mysteriously vanished for around a month during the summer, making it impossible to find anything with a Google search. Local businesses aren't happy. Some have been reporting a significant drop in online sales, for example.

Google has apologized, saying it has since fixed the technical error.

So can we live without Google?

It does pose that question, it seems.

Earlier, I spoke to Nicholas Thompson from "The New Yorker" magazine.

I asked him if the Sunrise incident demonstrates Google's monopoly power.


NICHOLAS THOMPSON, TECHNOLOGY EDITOR, "THE NEW YORKER": Google almost certainly does have a monopoly over search. Over maps, they don't have quite as much of a monopoly, because they do have a real rival in MapQuest. But it does show that when you have a very important feature -- maps, directions -- that are tied fundamentally into one company, there's a real problem. That company has a lot of power. If something goes wrong, you can lose a lot or that company can manipulate things.

And I think that's why people need to watch Google very carefully as a potential monop -- monopoly -- monopoly.

FOSTER: A fairly innocent mistake here. It doesn't have huge repercussions, although some businesses have, obviously, suffered. But in global terms, it doesn't have a huge impact. But that's just because of where this problem hit.

What if it hit a politically sensitive area in a foreign country?

THOMPSON: Right. It's kind of irrelevant what it did right now. I mean there are probably some dinner engagements where people were late and some companies said they lost some business. OK. It's too bad.

But there is a real question, Google has a lot of power in how we understand the world and where we think borders begin and where they end. Now, it doesn't really matter in Eastern Florida. But it does matter a lot, for example, in Israel. It does matter a lot in Kashmir. It does matter a lot in Tibet.

Where do you label the lines, who lives here, who lives there?

Google has to come up with these maps. And we've actually seen, in a number of circumstances, people protesting against the choices that Google has made and the decisions that they have made. And imagine the black -- backlash if Google suddenly had, you know, the Gaza Strip just disappeared from Google. It would -- there would be much more -- much more outrage than there was over Sunset, Florida.

FOSTER: Yes, exactly. And it was a surprise to a lot of people, the impact this had.

But do you think it was also a surprise to -- to Google?

THOMPSON: Oh, yes, I'm sure Google was very surprised. I mean one of the funny things about Google and I think one of the things we should remember is that Google, we type in these things and back comes this information. Or it guides us and it says, "turn right in 30 feet, not in 60 feet." And we think of it as this omnipotent, omniscient company with these algorithms that we can't understand. But what it turns out, it's right. And we have to remember that, well, actually it does churn out a bunch of information, but sometimes it's not right. Sometimes it's misleading. And sometimes it's totally forgotten whole categories of things.

So I think this should serve as a lesson and a reminder to people that this technology is highly, highly fallible.

FOSTER: And it leads you to the question is -- of whether or not we're over reliant on it now, we're trusting it too much?

THOMPSON: Well, I'm not sure we're trusting it -- we -- we're trusting it a lot and we should question it.

The question is, what would we trust if it wasn't for it?

You know, what would we trust for directions?

If we were trying to get to Sunset, Florida and we didn't have Google Maps, who would we -- how would we trust to get there?

Well, we'd have our little book in the car and we'd have the directions we wrote down from our aunt on the phone.

So we probably shouldn't trust Google completely, but we have to look at what would replace it and what we would trust instead of it when we decide whether we're giving it too much trust.


FOSTER: Google -- it's getting bigger all the time.

Now, a new tropical cyclone has just formed in the Caribbean. And Guillermo has been watching that for us -- hi, Guillermo.


They sent, actually, hurricane hunters that are planes that go on top of the hurricane, so above the eye. And they drop a device that actually measures pressure and winds and all that. And the National Hurricane Center has confirmed we have a new tropical cyclone. It's a tropical depression, soon to be Matthew -- a hurricane.

Where is it going?

Here it is. So we're going to -- in the Caribbean, right?

So look at the spaghetti models, what they suggest. Watch out, Honduras, Nicaragua, Belize and the Yucatan Peninsula. We will have it -- now I have the statistics coming from the National Hurricane Center, so you see, very soon to become a tropical storm, then impact here in Honduras and then landfall as a hurricane, again, in the case of Belize.

This is soaked. We have seen a lot of rain. So we may see some problems. So you have an idea what kind of terrain we have, look at the countries. Also remember that we have mountainous terrain in here. Honduras very prone to floods and to landslides, in this case -- flat here on that part. Then as we move a little bit farther to the north, we see some mountains and also on the islands, as well. So it's a very dangerous situation.

Canada, watch out, because soon we will have the impact of a new low pressure center with strong winds here into the Vancouver area. We have Vancouver Island. Also, I'm going to show you the terrain in here, Surrey. As you see, Vancouver -- this is Vancouver Island, right?

So big cities in the area are going to see very intense winds, an (inaudible) here and also on the other side of the -- the water, we have some other locales -- Max.

FOSTER: Well, once again, we are putting the spotlight on CNN Heroes.

Today, we're announcing 10 people who exemplify the best of humanity through their acts of kindness and of courage. There were 10,000 hero nominations from more than 100 countries. And a blue ribbon panel of business leaders, philanthropists and celebrities chose our top ten.

This hour, we introduce you to a California woman who's tried to ease the transition from incarceration to freedom.

Susan Burton knows from experience how hard it is to be imprisoned and make a new start. After the death of her son, she became addicted to crack-cocaine and served six prison terms on drug offenses back in the 1980s and in the 1990s. She broke the cycle and has helped hundreds of others to do the same.

Burton started A New Way of Life Reentry Project to offer newly released women a sober place to live and get support as they begin their new lives.

Now, we want you to become involved by voting for the hero who inspires you the most -- the CNN Hero of the Year. You can find more information on the honorees and the vote -- and to vote for your favorite at Voting ends on November the 18th. And you can vote as often and for as many heroes as you like. So get clicking.

We'll be back for an update in just a moment on the stock market.


FOSTER: Let's have a look at the markets. The U.S. market is pretty flat, actually. The NASDAQ may -- managing to have some small gains after a report showed right -- excuse me -- a rise in existing home sales. But this is what the Dow is doing, it's down marginally -- down .4 percent. As you can see, stocks fell earlier in the day after a surprise jump in jobless claims.

European stocks pared their losses, to finish lower on Thursday, after that positive U.S. housing data partially offset worries over Ireland's financial health. Weighing on sentiment for much of the day was a Eurozone survey of purchasing managers for September, which showed activity was the slowest in seven months.

We just want to tell you, we'll have much more on the problems surrounding the Commonwealth Games coming up on "CONNECT THE WORLD." Becky looks at the allegations that children are being used as laborers in New Delhi.

That's later.

"WORLD ONE" starts now.