Ah, clichés. They're the stuff life is made of, eh? There's always the danger of resorting to them in my line of work. When I see them in my own copy, I feel a little like Harvey Korman's character in the Mel Brooks classic film “Blazing Saddles.” Korman's character is Hedley Lamarr (It's not Hedy, it's Hedley!!), the evil state attorney general who recoils at the use of the cliché “head them off at the pass.” “I HATE that cliché,” Lamarr said in disgust. Lamarr might have been a fictional...

There's nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off. If you work for a firm intent on bringing a PMA device to market, FDA's insistence on a 1,000-patient post-approval study (PAS) for the Sapien transcatheter valve might have given you a bad case of deja vu because a small firm might not be able to get investors on board, even...

In this blog, we've explored the issue of NIH funding twice. The first time, we examined the reported fiscal spending numbers (here) and the second time, we examined funding by program areas (here), but now we have the budget/deficit ceiling debate, and yet we still see examples of truly nonsensical arguments about NIH funding. Let's acknowledge at least one thing: It makes no sense to fatten the NIH basic research pipeline when we know FDA can never keep up with it. It's akin to putting up a larger water...

We all find ourselves immersed in our work at times, but some jobs have tremendously broad appeal while others don't. For instance, lots of people want to own a vineyard, but even people who don't care for the idea like to talk about wine. In comparison, there are people like me whose heads are full of things most people don't care about. One day a few months back, I sauntered about mulling over the med-tech policy ramifications of something or other. Some time later, I noticed...

Late last month, the American College of Radiology Imaging Network (ACRIN; Philadelphia) along with the National Cancer Institute’s Lung Screening Study Group released the results of the National Lung Screening Trial (NLST). The study supports the idea that CT Screening in older, heavy smokers can reduce mortality rates by 20% compared to standard chest X-rays.  Nearly 53,000 current and heavy smokers between the ages of 55 and 74 at 33 sites across the U.S. were enrolled in NLST. (See full study here) It should be pointed out however that the study results show that CT Screening in these patients turned up a high...

I remember reruns of a cartoon about a character named Tooter Turtle, who was always appealing to Mr. Wizard to send him back in time for some form of jollies or other, and when the whole thing went south, Tooter would yell out, “help Mr. Wizarrrrrd!” At which point, Mr. Wizard would cluck about the futility of it all in his central European accent and bring Tooter back with the incantation, "drizzle, drazzle, druzzle, drome; time for zis one to come home." I never had any idea what that drizzle-drazzle stuff was all about, but it worked for Mr. Wizard....

There is an Irish aphorism which states: "Anything that keeps a politician humble is healthy for democracy." The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues of corporate America, but few media outlets are as punctilious about reporting on government's ill-intended moves. Here, then, are five reasons to mistrust government at least as much as device makers. Five: The Thompson Memo In 2003, this memo directed federal prosecutors to offer leniency to a corporate defendant if the defendant was willing to waive attorney-client privilege and/or willing...

A few weeks ago, I made the mistake of going into the gym around 6 p.m. That's the time when all the body builders and athletes tend to circulate in the area. I also made the mistake of getting on the treadmill next to someone who obviously looks like he runs track for a living. After seeing him run close to 10 mph without breaking a sweat - and I was struggling to do six -  I left the gym dejected. The competition in there was just too great. How could I possibly keep up with someone who can do a mile...

First, just to let you know dear reader, this is a Casey Anthony-free blog posting. Those who are skeptical of the device industry in this world are legion, but there are a lot of reasons to cast the occasional baleful glance at government as well. What's interesting is how many in the media automatically assume that any clash between FDA and industry is necessarily the fault of industry. Case in point: I was at the American Diabetes Association annual scientific sessions about two weeks ago and had a conversation with another member of the press. She said more or less...