Avandia

Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine. But within two weeks, his ankles started swelling. His weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs, who runs the Lionville Natural Pharmacy & Health Food Store in Chester County. The symptoms stopped after he went off the drug, he said. Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk.

GlaxoSmithKline P.L.C. agreed to pay $90 million to settle claims by 37 states, including Pennsylvania and New Jersey, and the District of Columbia that the company illegally promoted the Avandia diabetes medicine. The settlement resolves claims by state attorneys general that the London-based Glaxo misled consumers about whether Avandia caused heart attacks and strokes in order to pump up sales. The company has paid more than $3 billion to resolve government probes of its marketing of Avandia and other medications, as well as patient lawsuits over the diabetes drug.

GlaxoSmithKline lost a federal appeals court decision Thursday that could have costly repercussions for the company and other drugmakers whose products are later subject to investigations, recalls and lawsuits. The U.S Court of Appeals for the Third Circuit in Philadelphia ruled that Humana, one of the nation's largest insurance companies, could sue Glaxo to recover costs incurred by some Medicare patients who used versions of the diabetes drug Avandia, which was later pulled from the market because it was found to cause heart problems.

Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine. But within two weeks, his ankles started swelling. His weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs, who runs the Lionville Natural Pharmacy & Health Food Store in Chester County. The symptoms stopped after he went off the drug, he said. Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk.

A day after a new study suggested that the widely prescribed diabetes drug Avandia might increase the risk of heart attack and death, the prognosis for the medicine and its manufacturer, GlaxoSmithKline P.L.C., remained unclear. London-based GlaxoSmithKline, with U.S. headquarters in Philadelphia and North Carolina, stood by its statement Monday that it "strongly disagrees with the conclusions reached" in the New England Journal of Medicine article. At the same time, critics of the Food and Drug Administration continued to raise the specter of Vioxx, the Merck & Co. Inc. pain reliever that was pulled from the market three years ago after studies raised similar concerns and critics accused Merck of withholding other evidence of Vioxx's risks.

A Maryland doctor said she felt "threatened and disappointed" after GlaxoSmithKline P.L.C. urged her to stop discussing her concerns that the company's diabetes drug, Avandia, caused heart problems. Her assertion marks the second time that GlaxoSmithKline has been accused of trying to intimidate a researcher who pointed out problems with Avandia, which before its side effects became well-known was the top-selling diabetes drug. In 2007, University of North Carolina researcher John Buse testified before Congress that GlaxoSmithKline had called him a liar and suggested it might sue him if his comments about Avandia's potential safety problems caused the company's stock to drop.

You might think two of last week's biggest stories - financial reform and controversy over the diabetes drug Avandia - had nothing to do with each other. If so, you'd be wrong. Both are about a fundamental problem in any market economy: Bad incentives for businesses, stoked by the demands of Wall Street, can imperil us all. During the housing bubble, mortgage brokers had bad incentives to write risky loans to unqualified buyers, because they could sell the mortgages and dodge the risks themselves.

GlaxoSmithKline P.L.C.'s once popular diabetes drug Avandia received the government's strongest warning - a black-box label - yesterday, indicating that users may face a small but increased chance of heart attacks. But the Food and Drug Administration stopped short of banning the former blockbuster, saying Avandia did not appear to be more dangerous than other diabetes medicines. "We are keeping Avandia on the market because we have concluded there isn't enough evidence that the risk of heart attacks is higher than other treatments," said Janet Woodcock, the FDA's acting director of the Center for Drug Evaluation and Research.

GlaxoSmithKline P.L.C.'s diabetes drug Avandia does not increase the risk of heart-related hospitalizations and deaths, according to a company-funded study released yesterday. Critics said flaws in the study design rendered the results meaningless, and the authors of the paper, published in the British journal Lancet, acknowledged that the data on heart-attack risks were "inconclusive. " Avandia generated $2.2 billion in 2008 sales, but those numbers have been falling since 2007, when Cleveland Clinic cardiologist Steve Nissen published research saying that Avandia increased the risk of heart attacks by about 40 percent.

Older patients taking GlaxoSmithKline P.L.C.'s diabetes drug Avandia had an increased risk of death and heart failure compared with similar patients taking Actos, a competing diabetes drug. The study of about 28,000 patients, all of them older than 65, also concluded that neither drug should be considered very safe. The study, published yesterday in the Archives of Internal Medicine, was based on Medicare claims data from patients in Pennsylvania and New Jersey. Those who took Avandia had a 15 percent higher rate of death and a 13 percent greater risk of heart failure compared with those taking Actos, made by Takeda Pharmaceuticals North America Inc. "This study confirms the safety concerns that have been raised for rosiglitazone compared with pioglitazone, which, in turn, also cannot be considered a very safe drug given its well-documented effect on the risk of congestive heart failure," the study's authors said.

In the Region Pep Boys' quarterly loss widens   Pep Boys - Manny, Moe & Jack reported a bigger loss for its fourth quarter, largely attributable to a $17.8 million pension settlement charge. Net loss for the Philadelphia-based chain of 758 auto parts and service centers widened to $14.5 million, or 27 cents per share, for the 14-week period that ended Feb. 2. For a 13-week period a year ago, Pep Boys lost $4.4 million, or 8 cents per share. Revenues for the fourth quarter rose 5 percent to $530.8 million from $505.3 million a year ago. However, excluding that 14th week, comparable sales were down 2.6 percent.

GlaxoSmithKline P.L.C. agreed to pay $90 million to settle claims by 37 states, including Pennsylvania and New Jersey, and the District of Columbia that the company illegally promoted the Avandia diabetes medicine. The settlement resolves claims by state attorneys general that the London-based Glaxo misled consumers about whether Avandia caused heart attacks and strokes in order to pump up sales. The company has paid more than $3 billion to resolve government probes of its marketing of Avandia and other medications, as well as patient lawsuits over the diabetes drug.

In a significant departure from industry practice, GlaxoSmithKline P.L.C., said it would make available to outside researchers the raw but anonymous patient data from clinical trials for drugs it has developed or discontinued, and its tuberculosis compound library. Pharmaceutical companies generally don't divulge such information, claiming that it is a proprietary secret. "As a truly global health care company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," Glaxo chief executive Andrew Witty said in a statement.

Billion-dollar fines for inappropriate drug marketing are considered part of the cost of doing business for pharmaceutical companies, industry critics argue, and such conduct won't change until more executives go to jail for illegal activity. Asked Wednesday about that criticism, GlaxoSmithKline chief executive officer Andrew Witty said he would let "governments and society" choose the drivers of enforcement. But he insisted that his company's operations have improved under his watch, whatever anyone might think in the wake of Glaxo's recent $3 billion payment for conduct under its previous leadership.

GlaxoSmithKline lost a federal appeals court decision Thursday that could have costly repercussions for the company and other drugmakers whose products are later subject to investigations, recalls and lawsuits. The U.S Court of Appeals for the Third Circuit in Philadelphia ruled that Humana, one of the nation's largest insurance companies, could sue Glaxo to recover costs incurred by some Medicare patients who used versions of the diabetes drug Avandia, which was later pulled from the market because it was found to cause heart problems.

GlaxoSmithKline P.L.C. - which last week said it set aside $2.4 billion to settle lawsuits over its drugs Paxil and Avandia - agreed to pay $1 billion of that total to resolve more than 800 cases involving the antidepressant Paxil, Bloomberg News reported Tuesday. The agreements leave more than 100 cases pending on claims that antidepressant Paxil caused birth defects in some users' children, Bloomberg said, citing unnamed people familiar with the settlements. Hundreds of the Paxil cases were filed in Philadelphia.