Gambling and Restless Legs
(CBS/AP)
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August 9, 2007 2:21 PM You might have noticed that a common television ad for restless leg syndrome (RLS) now includes an unusual side effect: gambling. That’s right, if you suffer from Parkinson’s or RLS and suddenly find yourself in Vegas losing money you might be able to blame the drug you take. As of August 4, GlaxoSmithKline added “gambling, sexual or intense urges” to its list of side effects in its television ad for its drug Requip. The company says the warning has been disclosed in its print ads since July 2005 but this week’s change to its television ad was in response to an FDA request three months ago. The FDA did not respond to requests as to why it asked for the change. But two research studies published in the Archives of Neurology since 2005 identify gambling addictions as one of the possible side effects of taking Requip or its competitor Mirapex made by Boehringer Ingelheim Pharmaceuticals. Mirapex’s television advertising campaign already mentions gambling as a possible side effect.
February 13, 2007 9:45 PM
At this time of year weather is an important story, particularly given the unsettling mix of all the white stuff up North, the tornadoes down South and a brewing storm headed our way in the East. Not surprisingly, as I write this, weather is leading our broadcast, part of a “A” block chock full of stories pieces on North Korea, debate over the Iraq resolution in the House, and massive mall shooting in Utah. Busy, busy.
On almost any other night the story I worked on today would have made the show hands-down. It focused on a hearing in D.C. in which an insider blew the whistle on the drug manufacturer Sanofi Aventis, and alleged fraud in clinical trials involving its controversial antibiotic Ketek. My editors thought the script was strong (me too). The debate, as often happens, boiled down to a very few degrees. Was a story about Ketek, a drug used by about three million people last year for respiratory infections, more important than weather that could alter life for millions more?
Beyond the script I argued the Big Picture – a major drug manufacturer accused of knowingly passing along falsified drug data to the FDA and then coaching the head of its drug trials on how to deceive agency inspectors…
Guess what? A close call. But I lost. Snowed out by a snow day.
So we did what we often do – posted the piece here on the site. Only this time you get first look. I’d be interested to know what you think…
Snow Day Can't Cancel Ketek Story
We had a Snow Day on the Evening News tonight.
Video: At this time of year weather is an important story, particularly given the unsettling mix of all the white stuff up North, the tornadoes down South and a brewing storm headed our way in the East. Not surprisingly, as I write this, weather is leading our broadcast, part of a “A” block chock full of stories pieces on North Korea, debate over the Iraq resolution in the House, and massive mall shooting in Utah. Busy, busy.
On almost any other night the story I worked on today would have made the show hands-down. It focused on a hearing in D.C. in which an insider blew the whistle on the drug manufacturer Sanofi Aventis, and alleged fraud in clinical trials involving its controversial antibiotic Ketek. My editors thought the script was strong (me too). The debate, as often happens, boiled down to a very few degrees. Was a story about Ketek, a drug used by about three million people last year for respiratory infections, more important than weather that could alter life for millions more?
Beyond the script I argued the Big Picture – a major drug manufacturer accused of knowingly passing along falsified drug data to the FDA and then coaching the head of its drug trials on how to deceive agency inspectors…
Guess what? A close call. But I lost. Snowed out by a snow day.
So we did what we often do – posted the piece here on the site. Only this time you get first look. I’d be interested to know what you think…
February 13, 2007 4:01 PM 
Iowa Republican Senator Charles Grassley hammered the Bush Administration today for blocking his Senate Finance Committee investigation into FDA’s approval of the controversial antibiotic Ketek. And he personally attacked the president saying, “Well sometimes I wonder why I spent two days in the car with President Bush riding around the cold of Iowa to help get him nominated in the year 2000.”
Speaking before a House Energy and Commerce Committee hearing on the drug, Grassley said repeated requests to talk to an FDA investigator who worked on the Ketek case were rejected. And he says the FDA documents he received were heavily redacted. He says in one case even his own letter requesting documents to the FDA was returned to him with blacked out text.
Senator Grassley Blasts Bush
(GETTY)
Speaking before a House Energy and Commerce Committee hearing on the drug, Grassley said repeated requests to talk to an FDA investigator who worked on the Ketek case were rejected. And he says the FDA documents he received were heavily redacted. He says in one case even his own letter requesting documents to the FDA was returned to him with blacked out text.
February 2, 2007 5:07 PM
CBS News Investigative Update
The Los Angeles Times reported this week that Representative Gary Miller (R-CA) is under investigation by the FBI for shady land deals. We reported on his real estate shenanigans back in September.
This week the Pentagon announced they will no longer sell spare F-16 parts through its surplus service because of security breaches. We reported on security gaps in Department of Defense surplus sales back in July.
Also this week, the FDA announced it will overhaul its drug approval process. We highlighted the agency's approval process for the controversial antibiotic Ketek back in December, and were the first to note a congressional investigation into the drug’s approval resulting in hearings later this month.
Lastly, media outlets reported today that Florida has rejected the use of touch-screen voting machines which producer Phil Hirschkorn has been doggedly reporting on day in and day out. Read Phil's latest update here.
This week the Pentagon announced they will no longer sell spare F-16 parts through its surplus service because of security breaches. We reported on security gaps in Department of Defense surplus sales back in July.
Also this week, the FDA announced it will overhaul its drug approval process. We highlighted the agency's approval process for the controversial antibiotic Ketek back in December, and were the first to note a congressional investigation into the drug’s approval resulting in hearings later this month.
Lastly, media outlets reported today that Florida has rejected the use of touch-screen voting machines which producer Phil Hirschkorn has been doggedly reporting on day in and day out. Read Phil's latest update here.
December 15, 2006 6:19 PM
Recommended Withdrawal
An external FDA Advisory Committee has recommended that the controversial antibiotic Ketek 
be withdrawn for use in patients with bronchitis and sinusitis but remain on the market for pneumonia.
(CBS)
December 14, 2006 7:17 PM
Ketek Tragedy
At 80-years-old, Betty Watson was a vibrant and active member of her small-town Idaho community. She loved reading, playing cards, and spending time with her grandchildren. Suffering from a rare neuromuscular condition called Myasthenia Gravis, which can cause the skeletal muscles to weaken, she was otherwise in relatively good health according to her doctor. 
On November 27, 2005 she told her granddaughter Katie that she felt a sinus infection coming on and wanted to get put on antibiotics before it became more severe. She discussed her condition with a local doctor and he prescribed Ketek, a relatively new drug manufactured by Sanofi-Aventis. The prescription was called in and picked up at the local pharmacy that evening. When asked if there was anything the pharmacy should know about Watson’s condition, Katie informed them that she had Myasthenia Gravis. She took her first dose at about 9:30 and within three hours, Betty Watson was dead. But why?
(CBS/Watson Family)
On November 27, 2005 she told her granddaughter Katie that she felt a sinus infection coming on and wanted to get put on antibiotics before it became more severe. She discussed her condition with a local doctor and he prescribed Ketek, a relatively new drug manufactured by Sanofi-Aventis. The prescription was called in and picked up at the local pharmacy that evening. When asked if there was anything the pharmacy should know about Watson’s condition, Katie informed them that she had Myasthenia Gravis. She took her first dose at about 9:30 and within three hours, Betty Watson was dead. But why?
December 14, 2006 11:17 AM
FDA Oversight
No matter how you slice it Wednesday was not a great day for the FDA. 
In back-to-back stories on our Evening News broadcast we detailed widespread concerns about possible links between teenage suicide and anti-depressant drugs followed by my piece based upon a scathing Senate Committee report that raised troubling questions about a relatively new antibiotic, Ketek, and its links to serious liver damage.
(CBS/60 Minutes)
December 13, 2006 6:58 PM 
As we reported on tonight's CBS Evening News, Iraq war veteran Chuck Gregg ended up in the hospital after taking the antibiotic Ketek. Although, the FDA has continuously updated warnings of Ketek's possible side effects – including signs of liver problems – Gregg says because he had no previous liver problems, he had no reason to be concerned. He's now suing the manufacturer and pointing a finger at the FDA.
More On The Ketek Case
(AP)
Mike Huckabee on GOP "rock stars," 2012, health care reform and more.
