rom approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

How Much Input to The Administration and Congress’ Health Reform Plan Will Big Pharma’s $80B Pledge to Health Reform Buy?
When I heard about Big Pharma’s $80BILLION pledge, that was the first question that came to mind. Apparently wanting to give the Health Care Reform a boost, Drugmakers have agreed to foot the bill for $80 billion in Medicare drugs over the next decade. Some portion of that will benefit Medicare recipients, who, as you know, are on the hook for several thousand dollars’ worth of meds annually during the “donut hole” coverage gap. Some other portion will lower the cost of health reform, probably via bigger rebates to Medicare.

“Startups could co-locate with us and create a new type of foundation for discovery,” Witty told the International Association of Science Parks conference in Raleigh, home to one of the country’s largest research centers. And he reiterated GSK’s interest in small acquisitions and partnerships to provide a fresh jolt of new ideas for a company in bad need of good drug development programs. Witty also underscored that the presence of large academic institutions staffed with top researchers won’t be enough to woo companies like GSK in the future. Even more important, he says, is a pro-business attitude “to make the interface between industry and academia porous.”

The Congress has repeatedly looked at how it wants to fund the FDA. So once, twice, and again, last year, the Congress decided that the best way to fund the FDA was to look to the pharmaceutical industry to provide a portion of the funds to help support review. That’s the decision of the Congress. The pharmaceutical industry has contributed the funds to support the review, because we think that has been an effective approach. We also think that it’s been a way of helping to advance science.

The Health Decisions central system integrates all the components in a clinical study: data collection, adaptive randomization, site payments, administrative functions, and a reporting suite. “We’ve been using dedicated study websites for reporting and coordinating for 7-10 years,” says Rosenberg. “I assumed everyone was doing this. But almost nobody else does that. From a technology standpoint, this is a no brainer. It’s the quickest, easiest, most efficient way to distribute information.”