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The nonbinding recommendations raise the prospect the Food and Drug Administration could modify its approval of the Sanofi-Aventis SA drug, called Ketek, to exclude the treatment of the two lesser infections, which often clear up without drug treatment.

The FDA convened a two-day meeting of outside experts to discuss Ketek in light of concerns about its safety. An agency review found 13 reports of liver failure in patients treated with the drug through September. Reports of blurry vision also have been a concern. Doctors have prescribed the antibiotic more than 5.6 million times in the United States since the FDA approved it in 2004.

As CBS News Investigates reported on Dec. 13, there have been questions about the FDA’s handling of Ketek.

In an exclusive interview with CBS News, Dr. David Ross, who reviewed Ketek’s safety for the FDA, said he warned his superiors that the drug was, in his words, a «time bomb,» and was shocked last summer when the acting head of the agency, Dr. Andrew Von Eschenbach, told employees to keep concerns about the drug in-house — and out of the press.

Dr. John Jenkins, director 예천출장안마 of the FDA’s office of new drugs, declined to say what action the agency would take. The FDA isn’t bound to follow the advice of its outside experts, but usually does.

«We will be assessing the advice we received from the committee and discussing that very shortly,» Jenkins said.

The panel also recommended Sanofi-Aventis develop a medication guide to be given to patients, a move backed by the company.

Dr. John Edwards, of Harbor-UCLA Medical Center in Torrance, Calif., and the panel’s acting chairman, called the two-day meeting particularly challenging, since it came amid concern that companies have diminishing interest in developing new antibiotics and increased interest in safety issues linked to the drugs.

Many experts fear overuse of antibiotics is hastening the increasing resistance of many bacteria to older drugs, making the development of novel treatments critical. Some panelists suggested reserving Ketek for second-line use in treating pneumonia.

The label of the drug was changed in June to add a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal. A majority of panel members said that cautionary language should be strengthened and placed in a so-called «black box» to warn doctors and patients of some of the risks associated with the drug.

The FDA’s handling of Ketek remains under investigation by a Senate committee. Sen. Charles Grassley, R-Iowa, said this week the FDA intentionally withheld information from FDA advisers when they met in 2003 to consider recommending approval of the drug. FDA officials said they would comment after reviewing his allegations, contained in a 20-page letter sent to the agency.

Sanofi-Aventis said the risks associated with the drug, also known as telithromycin, appear to be comparable to those of other similar drugs and that it represents an important option in treating respiratory tract infections.


The South Carolina patient had eaten at a Pennsylvania Taco Bell

Over the weekend, Taco Bell officials said they determined that scallions were the likely source of the bacteria. But follow-up federal testing of those samples were negative for E. coli.

«In that context, we have not ruled out any food items,» said Dr. David Acheson, chief medical officer for the FDA’s Center for Food Safety and Applied Nutrition.

Health officials in New York said a sample of white onions taken from a Taco Bell restaurant tested positive for E. coli. However, that strain of bacteria hasn’t been linked to any cases of illness in the United States anytime in the previous 30 days. The positive sample initially was mistakenly identified as being green onion, Acheson said.

«The bigger possibility is that these white onions were contaminated somewhere else, the supplier or the grower. We don’t know that,» Acheson said. «It does not match any strain of any illnesses in the past 30 days.»

The Centers for Disease Control and Prevention has confirmed 64 E. coli cases in five states, most in New Jersey, New York and Pennsylvania plus two in Delaware and one in South Carolina. The South Carolina patient had eaten at a Pennsylvania Taco Bell.

A New York City resident fell ill after eating at Taco Bell and health officials confirmed that E. coli was the culprit. The victim, identified only as a Staten Island resident, has since made a full recovery. This was the first time the strain was found in the city.

Meanwhile, nearly three dozen people have fallen ill with symptoms consistent with E. coli infection after eating at a Taco John’s restaurant in Cedar Falls, Iowa. And authorities were investigating a case in which several people became ill after eating at a Taco John’s in Albert Lea, Minn.

Kirk Smith, with the Minnesota Department of Health, said tests were being conducted to determine whether the illnesses were related to illnesses in Iowa.

Three Minnesotans with the symptoms are ages 17, 35 and 57, the Star Tribune of Minneapolis reported on its Web site Monday. The oldest person has developed a kidney complication and is hospitalized, the newspaper said.

Paul Fisherkeller, president of the Cheyenne, Wyo.-based Taco John’s, said in a statement, «We hope for the speedy recovery of anyone who has fallen ill and are cooperating fully with health departments in both states, while also conducting our own investigation.»

There is no indication the outbreaks at the two taco chains are linked, but the CDC has not ruled out a connection, said Dr. Christopher Braden, a medical epidemiologist with the agency. Iowa officials suspect a sick restaurant worker could have spread the illness. The two restaurant chains are not related.

It could take until midweek to determine if the Taco Bell outbreak is over, Braden said. However, there have been no reports of anyone falling ill after Dec. 2, he added.

Taco Bell continued to exclude scallions from its ingredient list despite the FDA’s finding. «We won’t be considering any changes to our decision until the FDA and CDC conclude their investigation,» Taco Bell spokesman Rob Poetsch said.

Taco Bell President Greg Creed said that independent testing on ingredients served in the chain’s restaurants did not indicate the presence of E. coli bacteria.

«As nearly half the entire U.S. adult population eats at a Taco Bell at least once a month, it’s easy to understand how we might be considered associated with this illness,» Creed said in a statement issued from Irvine, Calif., where the subsidiary of Yum Brands Inc. is located.

«Based on this testing and all that we know today, I can reassure you that all Taco Bell food is safe and strict standards are being upheld at all of our restaurants,» he said.

E. coli is a common and ordinarily harmless bacteria, 양양출장안마 but certain strains can cause abdominal cramps, fever, bloody diarrhea, kidney failure, blindness, paralysis, even death.

It is found in the feces of humans and livestock. E. coli infections are associated with undercooked meat. The bacteria also can be found on sprouts and leafy vegetables. The germs can be spread by people if they do not thoroughly wash their hands after using the restroom.


Team tragedies: Plane crashes in sports worldKHL chief vows to rebuild team after plane crashRussia jet crash kills 43, many top hockey stars Unlike many other members of Lokomotiv who were European Union citizens and once played in the NHL, Galimov was a native of Yaroslavl and a product of its youth program

MOSCOW — The only member of a top Russian hockey team to survive a plane crash that killed 44 people died Monday of his injuries in a Moscow hospital.

The Vishnevsky hospital said 26-year-old Alexander Galimov died of the severe burns that covered about 90 percent of his body, despite the best efforts of doctors in its burn unit, considered one of the best in Russia.

The crash Wednesday of a chartered Yak-42 jet outside the western city of Yaroslavl took the lives of 37 players, coaches and staff of the local Lokomotiv Yaroslavl ice hockey club. The only other person to survive, flight crew member Alexander Sizov, remained in intensive care at Moscow’s Sklifosovsky hospital.

Team tragedies: Plane crashes in sports worldKHL chief vows to rebuild team after plane crashRussia jet crash kills 43, many top hockey stars

Unlike many other members of Lokomotiv who were European Union citizens and once played in the NHL, Galimov was a native of Yaroslavl and a product of its youth program.

His death is certain to be deeply mourned in the city, where the team’s consistently strong performance was a source of great pride.

At rallies following the crash, fans chanted «Galimov, live for the whole team!» and other slogans dedicated to him.

«All of Yaroslavl, all of the country, all of the world followed the doctors’ words, believing, hoping, praying that he would defeat death and remain with us,» Yaroslavl Gov. Sergei Vakhrukov said.

The governor described Galimov, a forward, as a fan favorite who remained true to his home club for 성주출장안마 many years.

«He carried the team spirit of Lokomotiv and through his indomitable character often reversed the course of the most difficult games,» Vakhrukov said.

A memorial ceremony Saturday in the Lokomotiv ice arena drew an estimated 100,000 people, including Prime Minister Vladimir Putin.

The crash, one of the worst ever aviation disasters in sports, shocked all of Russia and the international hockey community.

The team was heading to Minsk, Belarus, to play its opening game of the Kontinental Hockey League season when the plane crashed into the Volga River bank shortly after takeoff and burst into flames.

Russian aviation experts say they have come to no conclusions yet about the cause of the crash. The plane appeared to have trouble gaining altitude, but investigators said its flight data recorders showed that all three engines were operating up until the moment the plane crashed.

Aviation authorities have also launched safety checks on all the approximately 60 Yak-42 jets still in service in Russia, and grounded at least four of them.

Experts blame Russia’s poor aviation safety record on an aging fleet, weak government controls, poor pilot training and a cost-cutting mentality.


«That’s my thing,» she replied

(CBS News) The singer-actress is also a fashionable business tycoon who tells our Lee Cowan «workaholic» is not a dirty word:

(An earlier version of this report was originally broadcast on May 19, 2013.)

It left very little to the imagination; that green Versace dress that Jennifer Lopez wore to the Grammys back in 2000 was a daring design, to say the least.

But fashion has always been JLo’s passion — stylishly showing off those famous curves, both on stage and off.

With her recent single with rapper Pitt Bull, «Live It Up,» Lopez isn’t just back to making music. She’s back at the design table, too.

She inked a multi-million dollar design deal with retailing giant Kohl’s two years ago. Now, you name it — and HER name is on it.

She’s even designed her own brand of bedding — in addition to the sportswear, dresses, handbags, jewelry, shoes and 오산출장안마 sleepwear.

Does it get overwhelming? asked Cowan.

«Of course! Of course it’s overwhelming sometimes,» Lopez replied. «And yes, you’re right, at times, I’m like, Whoa, what am I taking on? I’m taking on so much. It’s so overwhelming.

«But I feel like, life is overwhelming, and you can’t be afraid of that.»

She got the attention of Forbes Magazine, which put her at the top of its list of the World’s Most Powerful Celebrities last year, in part because her deal with Kohl’s was so big — a 20-year contract with seven-year options.

«But that’s crazy, right?» said Cowan.

«I don’t know, who likes to talk about this stuff? Not me!» she replied. «I just like to play clothes, you know what I mean? Like, let’s design the clothes and let’s have fun. And what colors are we going to use? And ooh, I think you should do this shape. You know, like that’s my fun part.»

And that «fun part» is only a fraction of her design drive.

As a Chief Creative Officer, JLo is helping design a network, too: NUVO-TV, the first English-language cable station geared to a Latino audience.

«It seems that anything with a creative, design bent, you’re all over it,» said Cowan.

«That’s my thing,» she replied.

She is certainly in demand — and sometimes it’s gotten her in trouble.

In June she headlined a birthday party for the leader of Turkmenistan, a country with a dismal human rights record. Lopez later apologized.

She broke onto the scene in 1997 in «Selena,» the biography of the late Tejano music star. She soon branched into her own music — and her career took off.


The study was paid for by Britain’s National Institute of Health Research

Dr. Omar Faiz, 강진출장안마 a consultant surgeon at St. Mary’s Hospital in London and colleagues monitored the number of weight-loss surgeries done in government hospitals from 2000 to 2008. Overall, they found 6,953 such operations were performed, including three different types of surgeries, all designed to shrink the size of the patient’s stomach.

In 2000, there were 238 weight loss surgeries, but by 2007 there were 2,543 such operations. The study was paid for by Britain’s National Institute of Health Research.

Faiz described the increase in surgeries as «exponential,» but was unsure if it would continue.

«We don’t know whether we’ve seen the summit of the peak, but the trend still looks to be going upwards,» he said. He said there were not enough data to know how many obese people were awaiting the surgery in England, but said the number of people getting the surgery was likely only a small proportion of those who qualified for it and wanted it.

Faiz and colleagues found that the majority of patients who got the weight loss surgeries were women and were from poorer areas. Most patients were in their 40s. The surgeries also appeared to be safe; the risk of dying one year after the surgery was about 1 percent. The study was published Friday in the medical journal, BMJ.

Since 2002, when Britain’s health watchdog recommended weight loss surgery for morbidly obese people, usually defined as those with a Body Mass Index above 40, there has been a sharp increase in the number of such procedures.

Some experts weren’t surprised by the figures and said the obesity epidemic was likely to accelerate the demand for such surgeries in the future.

«It’s very alarming that people have been allowed to get so fat without anyone intervening in time, said Tam Fry, spokesman for the National Obesity Forum, a British advocacy group. He was not connected to the BMJ study.

«The fat are getting fatter and fatter and the gap between the healthy and the very unhealthy is growing,» Fry said, warning that paying for more weight loss surgeries would be a huge burden for the British government. He said experts should focus on preventing obesity before surgery becomes necessary.

«People have the idea that they can eat and eat and then get (weight loss surgery) to solve the problem,» he said. «That will be disastrous both for the individual and for the state.»

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