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Source: http://twitter.com/sctimes/statuses/220710364403347456
Friday, July 6, 2012
Wednesday, July 4, 2012
GlaxoSmithKline to pay $3B for health fraud
TRENTON, N.J. (AP) ? British drugmaker GlaxoSmithKline will pay $3 billion in fines ? the largest health care fraud settlement in U.S. history ? for criminal and civil violations involving 10 drugs that are taken by millions of people.
The Justice Department said Monday that GlaxoSmithKline PLC will plead guilty to promoting popular antidepressants Paxil and Wellbutrin for unapproved uses. The company also will plead guilty to failing to report to the government for seven years some safety problems with diabetes drug Avandia, which was restricted in the U.S. and banned in Europe after it was found in 2007 to sharply increase the risks of heart attacks and congestive heart failure.
In addition to the fine, Glaxo agreed to resolve civil liability for promoting Paxil, Wellbutrin, asthma drug Advair and two lesser-known drugs for unapproved uses. The company also resolved accusations that it overcharged the government-funded Medicaid program for some drugs, and that it paid kickbacks to doctors to prescribe several drugs including Flovent for asthma and Valtrex for genital herpes.
Sir Andrew Witty, Glaxo's CEO, expressed regret Monday and said the company has learned "from the mistakes that were made."
This is the latest in a string of settlements related to drug companies putting profits ahead of patients. In recent years, the government has cracked down on drugmakers' tactics, which include marketing medicines for unapproved uses. While doctors are allowed to prescribe medicines for any use, drugmakers cannot promote them in any way that is not approved by the U.S. Food and Drug Administration.
"Let me be clear, we will not tolerate health care fraud," Deputy Attorney General James M. Cole said Monday during a news conference at the Justice Department in Washington.
Glaxo is scheduled to plead guilty to the criminal charges and have the settlement approved at a hearing Thursday in U.S. District Court in Boston. In addition to the $3 billion penalty ? which includes a $1 billion criminal fine and forfeiture and $2 billion to resolve civil claims ? Glaxo agreed to be monitored by the government for five years to ensure that it complies with marketing and other rules.
The case against Glaxo was originally brought in January 2003 by two whistleblowers, former Glaxo sales representatives Greg Thorpe and Blair Hamrick. In January 2011, the federal government joined in the case.
Prosecutors said Glaxo illegally promoted Paxil for treating depression in children from 1998 to 2003, even though it wasn't approved for anyone under age 18. The company also promoted Wellbutrin from 1999 through 2003 for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depression.
Starting in 2001, Thorpe reported to his district manager, then to Glaxo's human resources department and finally to Glaxo's chief of global compliance about a number of improper marketing practices. The compliance chief began an internal investigation, which confirmed Thorpe's allegations through various ways including marketing materials and interviews with Hamrick and other sales representatives, according to lawyers for the two men.
Brian Kenney and Tavy Deming, attorneys for the two salesmen, said top management did nothing to stop the illegal practices, pressured Thorpe to resign and later fired Hamrick for allegedly not cooperating with the company's investigation of one kickback allegation.
According to Deming, Hamrick reported that at a 2000 regional meeting of sales representatives in Las Vegas, they were directed to promote Wellbutrin as the drug that makes patients happy, skinny and sexually turned on, part of a catchy national slogan repeated to doctors.
Thorpe said in a statement Monday that he was penalized after he reported kickbacks being paid to doctors and sales reps encouraging doctors to promote drugs for unapproved uses, including using Paxil and Wellbutrin in children.
"In the end, I was told that my concerns were not valid. I was put on leave" after a 24-year career, Thorpe said. He added that he was told to either "take a severance package or go back to work for the same people, doing the same things I had reported to management."
Thorpe and Hamrick ? and two other sales rep whistleblowers who joined the case shortly after them ? will receive an as-yet undecided portion of the $3 billion settlement.
The Glaxo case underscores how aggressive the Justice Department has become in going after similar cases. In a May settlement, Abbott Laboratories pleaded guilty and agreed to pay the government a $700 million criminal fine and forfeiture for promoting Depakote, approved for bipolar disorder and epilepsy, for use in patients with dementia and autism. That was on top of civil settlements with numerous states and the federal government totaling $800 million.
Prior to the Glaxo settlement, the record-setting case involved Pfizer Inc., the world's biggest drugmaker. It paid the government $2.3 billion in 2009 in criminal and civil fines for improperly marketing 13 different drugs, including erectile-dysfunction drug Viagra and cholesterol fighter Lipitor, the top-selling drug in the world for years. Pfizer was accused of encouraging doctors to prescribe its drugs with free golf, massages and junkets to posh resorts.
"For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," said Acting Assistant Attorney General Stuart F. Delery, head of Justice's civil division. "Today's resolution seeks not only to punish wrongdoing and recover taxpayer dollars, but to ensure GSK's future compliance with the law."
___
Associated Press writer Jesse J. Holland in Washington contributed to this story.
___
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
Source: http://news.yahoo.com/glaxosmithkline-pay-3b-health-fraud-235323110--finance.html
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Tuesday, July 3, 2012
Nomura dumped as Development Bank of Japan bond underwriter
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Source: http://news.yahoo.com/nomura-dumped-development-bank-japan-bond-underwriter-061729133--sector.html
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Torres moving on after Olympic bid fails
Dara Torres, left, looks at the results after swimming in the women's 50-meter freestyle final at the U.S. Olympic swimming trials as Kara Lynn Joyce and Jessica Hardy, right, celebrate, Monday, July 2, 2012, in Omaha, Neb. (AP Photo/Nati Harnik)
Dara Torres, left, looks at the results after swimming in the women's 50-meter freestyle final at the U.S. Olympic swimming trials as Kara Lynn Joyce and Jessica Hardy, right, celebrate, Monday, July 2, 2012, in Omaha, Neb. (AP Photo/Nati Harnik)
Dara Torres, left, and Jessica Hardy waits for the results after swimming in the women's 50-meter freestyle final at the U.S. Olympic swimming trials, Monday, July 2, 2012, in Omaha, Neb. Hardy won the final. (AP Photo/Mark J. Terrill)
Dara Torres, right, congratulates Kara Lynn Joyce after swimming in the women's 50-meter freestyle final at the U.S. Olympic swimming trials, Monday, July 2, 2012, in Omaha, Neb. (AP Photo/Mark J. Terrill)
Dara Torres swims in the women's 50-meter freestyle final at the U.S. Olympic swimming trials on Monday, July 2, 2012, in Omaha, Neb. (AP Photo/Nati Harnik)
Andrew Gemmell swims to victory in the men's 1500-meter freestyle final at the U.S. Olympic swimming trials, Monday, July 2, 2012, in Omaha, Neb. (AP Photo/Mark J. Terrill)
OMAHA, Neb. (AP) ? Dara Torres is headed back to Florida to watch the Olympics on TV, like a lot of middle-aged folks.
The 45-year-old mom missed making a record sixth U.S. swim team by nine-hundredths of a second, finishing fourth in the 50-meter freestyle on the last night of the trials Monday.
"This is really over," she said, smiling. "That's it, I'm going to enjoy some time with my daughter, have a nice summer and cheer on the U.S. team from afar."
Torres carried 6-year-old Tessa, her blond head buried in her mother's shoulder, as she came off the pool deck and made her way past reporters for the last time.
"She's bummed she's not going to London now," Torres said. "I told her I'd still take her though."
Torres will have extra time now to help her daughter get ready for first grade in the fall. Always a fitness fanatic, she'll still work out, just not at the highest level required of an elite athlete. And Torres admits it'll be nice to stop worrying about whether she can recover enough to swim three races in quick succession.
"Mentally it's been so tough the past couple years with having more bad workouts than good workouts and going to meets and not being able to go faster at night than I did in the morning," she said.
"I'm used to winning, but that wasn't the goal here. The goal was to try to make it. I didn't quite do it, but I'm really happy with how I did."
Asked if she was immediately going to sign her retirement papers that would end drug testing, Torres joked, "Oh, I'm calling USADA tonight."
After winning three silver medals at the Beijing Olympics, Torres underwent radical knee surgery and put all her hopes into a chaotic dash from one end of the pool to the other. But 25-year-old Jessica Hardy won in 24.50 seconds, while 26-year-old Kara Lynn Joyce took the other Olympic spot in 24.73.
"I don't think there's anything I could have changed," Torres said. "You got to look at it realistically. As much as I want to win and I wanted to make the team, that's pretty good for a 45-year-old."
Hardy said it was an honor to compete against Torres, who retired twice but came back to win five medals at the 2000 Sydney Games, then three more silvers in Beijing.
"I love racing Dara," Hardy said. "I wish she could have made it this year, but swimming with her the past couple years has been really an awesome treat for sure."
Torres finally ends a career that began at her hometown Los Angeles Games in 1984. She won 12 Olympic medals, tied with Jenny Thompson as the most decorated U.S. female swimmer. Torres became the first American to swim in five Olympics and the oldest female swimmer ever at the games.
"This time around is going to be the most special to me," she said. "The crowd was so wonderful and I've had so much great support."
Before she stepped on the blocks, Torres remembered her late coach, Michael Lohberg, who died in 2011 from a rare blood disorder that was diagnosed just before she swam in Beijing.
"I was very emotional before my swim," she said. "When I was putting my suit on with my trainer, Anne Tierney, we started crying because I started thinking about Michael. In July of 2010, he had said to me, 'Let's go for this.' I really wanted to finish the story that I started with him. I didn't make it but I know he would have been proud."
Torres was among the big names missing the team.
Katie Hoff, who won three medals in Beijing, failed to qualify. So did four-time Olympian Amanda Beard, Ed Moses, Garrett Weber-Gale and 40-year-old Janet Evans, who came back from a 15-year retirement. Natalie Coughlin, an 11-time medalist, didn't make any of her individual events and will have to settle for a relay spot.
The eight-day trials came to a close with the grueling 1,500 freestyle. Andrew Gemmell won in 14 minutes, 52.19 seconds, powering to the wall just ahead of Connor Jaeger, who took the second spot for London in 14:52.51.
Gemmell tried to make the team in open water, but finished third in those trials. He switched to the pool and made his first Olympics.
"I just wanted to treat it like open water, and I knew I had to swim my own race," he said. "I knew people would be going out faster than me, and I would have to race coming home."
Associated PressShort stretches of piRNA evaluate cells' genetic history
Monday, July 2, 2012
As scientists have added to a growing list of types of RNA molecules with roles that go beyond conveying the genetic code, they have found the short strands known as Piwi-interacting RNAs (piRNAs) particularly perplexing. New work from Howard Hughes Medical Institute (HHMI) scientists suggests those abundant molecules may be part of the cell's search engine, capable of querying the entire history of a cell's genetic past.
Organisms contain thousands of piRNA molecules, strands of 26 to 31 nucleotides encoded all over the genome. In two studies published online June 25, 2012, in the journal Cell,HHMI investigator Craig Mello of the University of Massachusetts Medical School has discovered that piRNAs may be responsible for detecting foreign RNA?such as that carried by viruses -- relying on a complex search mechanism to reveal whether an invader is foreign based on prior gene activity.
"piRNAs are found in all animals and some of their functions in some organisms have been explained," says Mello. "But overall they've been a very mysterious category of molecule."
Some piRNAs have sequences that match up identically to genes elsewhere in the genome, suggesting that they bind and regulate those genes. But most have no perfect genetic match. Mello and his team focused their attention on the more puzzling piRNAs -- those that had no obvious targets.
In the worm Caenorhabditis elegans,the scientists unexpectedly found that foreign genes that they inserted into the genome were sometimes silenced and sometimes not. When they genetically modified the worm to lack the Piwi protein, the silencing no longer worked.
When the researchers probed which sequences piRNAs tended to shut down, they found that if a cell has ever turned on a gene in the past, the piRNA system will recognize it as a "self" gene and allow it to be expressed. But if it hasn't been active in the organism before, the piRNA will set the silencing mechanism into action so it remains off.
The silencing or lack of silencing is permanent, they found. If the piRNA doesn't silence a gene the first time it encounters it, it won't ever silence it. And if it silences it once, then every time that gene appears in the future, the system will turn it off.
"This is really remarkable," says Mello. "It implies that an organism has a memory of all the previous gene sequences it's ever expressed before."
The researchers think that the snippets of piRNA do not hold the memory in their sequences. Rather, two other small RNA pathways are thought to provide epigenetic memories of "self" and "non-self" RNA. Mello says piRNAs likely allow mismatched pairing as they scan, so that virtually they can potentially recognize all sequences that have been expressed. Silencing occurs only when a sequence has not been seen before.
While people have hypothesized that foreign RNA is recognized by cells as foreign based on a particular feature of the molecule?like a structural element or chemical tag?the new results suggest that the recognition may be sequence based.
That's not all Mello's lab discovered about piRNAs. Not only did the gene silencing pattern that they establish persist throughout an organism's life, but the memory was passed very stably between generations.
"These small RNAs are present in the germline at all stages and are transmitted to both the egg and the sperm," says Mello.
When genetically identical animals exhibit opposite and heritable phenotypes, the mechanism of inheritance is dubbed epigenetic. In this case, the inducers of epigenetic silencing are piRNAs, so with that in mind, Mello coined the term RNAe, for RNA-induced epigenetic silencing.
A last highlight of the team's findings was that although an organism retains its pattern of piRNA silencing throughout its lifetime, each individual establishes its own pattern. While one may silence a gene everytime it encounters it, another may allow its expression.
"It's interesting that the animal is a little bit lenient," says Mello. "Maybe we don't necessarily want to shut off everything that we haven't seen before. Maybe there is some adaptive value to this type of variation."
More questions than answers remain about RNAe: What are all its targets? How exactly is the memory of past gene expression stored? And does the system react to changes in the environment, allowing more or fewer silenced genes to express in times of stress?
"So far, these small RNA systems are turning out to be really remarkable," says Mello. "But there's lots more to nail down."
###
Howard Hughes Medical Institute: http://www.hhmi.org
Thanks to Howard Hughes Medical Institute for this article.
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Source: http://www.labspaces.net/121386/Short_stretches_of_piRNA_evaluate_cells__genetic_history
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