Derek Lowe of Seeking Alpha says a retrospective analysis of the GSK diabetes blockbuster Avandia suggests a worrisome safety profile. He cites a study of 14,000 Medicare patients on Avandia with a higher mortality rate (15 percent) than a similar population taking Actos, a competing drug from Takeda. GSK disputes the safety finding and says a head-to-head trial comparing the drugs would be needed to settle the issue. Lowe concedes that point, but notes neither GSK or Takeda has started such a project. Here’s the story.

In another sign of a tightening regulatory environment, Lilly pulled the paperwork on an application to market its anti-depressant Cymbalta for chronic pain. Lilly says it decided to pull the application after the FDA questioned Lilly’s studies and statistical methodology. Current approvals for indications such as depression, anxiety, diabetic peripheral neuropathic pain and fibromyalgia are not affected. Lilly posted third-quarter sales of $716.4 million for Cymbalta, its second-largest revenue-generating drug after Zyprexa, up 40 percent from a year earlier. Here’s the story.

As we noted last week, the FDA is unwilling to take data for Johnson & Johnson (JNJ) antibiotic ceftobiprole and is asking for additional information about investigator sites and monitoring. The FDA seems to be devoting additional scrutiny to antibiotics in the aftermath of the controversial approval of Ketek: the agency recently rejected marketing applications for Doribax (from JNJ) and and Tygacil (from Wyeth). It’s still unclear whether the regulatory hurdles for antibiotics have changed permanently, or are just a temporary tightening to impress a new regime in Washington. Here’s another story.

Fortune magazine has a positive article on the prospects of Pfizer. The magazine notes the company’s $26 billion cash reserve and cites a Wall Street analyst, Deutsche Bank’s Barbara Ryan, who believes the company is working on a little-recognized and far-reaching cultural shift that will allow it to reverse its current slide. As much as 41 percent of the big pharma’s current revenue will vanish by 2012; and only part of that is from Lipitor. Here’s the article.

What percentage of hospitals use electronic health records (EHR)? The number is disputed. The suppliers of the technology cite upwards of 25 percent; medical journals estimate usage at less than 5 percent. Now Ashish Jha of Harvard’s School of Public Health and Catherine DesRoches of the Institute for Health Policy tell a U.S. Health and Human Services Department advisory committee about a new survey. It showed just 2 to 12 percent of U.S. hospitals using EHRs. “This is somewhat sobering,” Jha said. The survey was done this year in conjunction with the American Hospital Association; it received responses from more than 3,000 U.S. non-federal hospitals, one of the largest samples ever. Here’s the story.d9A2t49mkex

Sparta Systems, a supplier of regulatory software, announced two new hires. Tom Dalle-Molle (formerly of SAP) will be VP of North American sales, and Nathan Birtle (formerly of PeopleSoft) will be VP of European and Asian-Pacific sales. “The industry looks to Sparta to produce innovative solutions that drive efficiency and compliance efforts across the global supply chain,” said James McGowan, president and CEO. “We’ve strategically appointed Tom and Nathan, two stellar software executives, to lead our worldwide sales efforts. The experience these veterans bring to Sparta will position the company for future growth.” Here’s the release.

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