ProSanos released Safety Works, which was developed jointly with GSK. The software is “a web-based, semi-automated software system that can help scientists more quickly spot and measure the strength of associations between a drug and a medical condition found within large electronic healthcare databases,” the company said. GSK’s Edward Pattishall, VP of safety, added, “GSK is committed to enhancing patient safety and anticipate[s] this tool will be extremely helpful in evaluating the benefit/risk profile of our medicines using multiple data sources that can’t currently be easily and quickly compared.”

A podiatry journal has an article on socks that aspire to blunt foot pain. The author, Maureen Jennings, says the socks don’t work. Here’s an abstract.

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PPD is featured in a subscription-only article in Barron’s this week. The story notes PPD’s discovery partnerships and touts it as an investment. Barron’s says the contract research industry could be a $38 billion market by 2013. An excerpt: “Profits and revenue grew more than expected in the quarter. And operating margins rose from a year earlier and the previous quarter.”

The FDA’s Center for Devices and Radiological Health (CDRH) has released a new method for electronic submissions. Here’s an FDA link and an article.

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The New England Journal of Medicine, in its first filing to the Supreme Court, says an out-gunned FDA cannot ensure drug safety on its own. Personal injury lawyers, the doctors say, are providing an important service in protecting the public from unsafe medicine. This fall, in a landmark case called Wyeth v. Levine, the high court is expected to outlaw lawsuits against the drug industry. Congress is already considering legislation to permit such cases. The brief from the NEJM is an extremely critical discussion of the abilities and intentions of both the pharmaceutical industry and the FDA. We’ll quote an uncharacteristically gentle passage: “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,” the editors write. The Wall Street Journal has the NEJM filing.

Merck’s motives in the Advantage trial of Vioxx are under scrutiny. The Annals of Internal Medicine says the trial had scientific window-dressing but was driven by marketing professionals who hoped to get more doctors to prescribe the painkiller. The journal cites internal Merck documents from litigation. The article states: “The trial was designed by Merck’s marketing division to fulfill a marketing objective; Merck’s marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members.” Merck defended the study. But damage-control efforts are complicated by email from a revered Merck physician, Edward Scolnick. He was on record with colleagues saying the Advantage trial was ill-advised. With a Merck building named after him at Harvard and a previous career as a federal researcher, Scolnick ran Merck’s R&D effort from 1985-2002. Here’s the article.

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