Disclosure and transparency. They’re recurring themes often sung by lawmakers and critics who would have us believe that even the gift of a drug-labeled pen will put doctors and medical students under the influence of biopharma. You’ve heard the refrain. Calls for disclosure on journal articles and citizen petitions. Reminders to disclose drug ties when testifying before Congress or an advisory committee. Requirements for doctors and researchers to disclose personal or family ties with industry when serving on an FDA advisory committee. What you haven’t heard are demands that biopharma critics disclose where they get their funding. And when’s the...

Earlier this month my wife and I had a beautiful baby daughter, and as you can imagine, the demands for pictures are flooding in.  This can be pretty problematic for us seeing as how we don’t really have a Facebook page, where we can disseminate pictures to all those who are requesting a glimpse of our lovely daughter's visage,  in one click of a button. Everything with us, is done by email or text messages. But there’s a reason for that, and a good one.  See we don’t really want our message out for the whole world to see. My wife and...

Biopharma is often the scapegoat for the escalating cost of healthcare, especially when it comes to the price of brand drugs. But since it’s hard to put a price on health and a long life, what gets lost in this focus on the bottom line is the public return on investment (ROI). National Institutes of Health (NIH) Director Francis Collins made that case last week when he testified before a Senate appropriations subcommittee. “Due in large measure to NIH research [and better treatment], our nation has gained about one year of longevity every six years since 1990,” he said. But...

Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial.” Not until the second paragraph did readers find out the most important tid-bit: that the FDA had denied their appeal regarding the cancer drug, which received a complete response letter last year. Meanwhile, Vivus Inc. issued first quarter earnings late Monday, but the piece of news everyone was most interested in – the path forward...

Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings, companies testing their experimental drugs in conjunction with pegylated interferon and rebavirin (PR) vs. PR alone may find enrollment and retention challenging, especially for treatment-naïve subjects. In a three-arm study that includes PR alone, patients would be signing up for a 33 percent chance of a year of flu-like symptoms with a cure rate of about 45 percent, at best....

Politics, economics, and NIH spending priorities By MARK McCARTY Medical Device Daily Washington Editor Government that makes sense. It's what we all dream of, but when it comes to spending priorities at the U.S. National Institutes of Health, we might as well wish to lose weight on the see-food diet. FYI: That's the diet on which when you see food, you eat it. What do I mean? Here's what I mean. NIH's budget for the National Cancer Institute in fiscal 2010 was a bit more than $5.1 billion (click here), but the budget for the National Heart, Lung, and Blood...