The week is at a close. So is September. And, a week’s vacation for me at Cape Hatteras also comes to an end. It was nice, but I’ve had to rely on dial-up, which has made posting to the blog a very time consuming process. And on Monday, the Supreme Court begins its new term, with lots on their plate.
But here is some of what happened while I was gone:
- DHS Inspector General Report Blasts FDA Oversight of Clinical Trials – A new report to be released today by the Department of Health and Human Services Inspector General really lights into the track record of the FDA in protecting the interests of patients in clinical trials, the New York Times has reported. It is an important report given the source and signals that the FDA’s troubles may not be over, despite the enactment of reform legislation. Look for some future hearings and legislation along these lines in the coming months.
- Thumbs Down on a COX-2 – The FDA issued a non-approvable for a COX-2 painkiller by Novartis called Prexige, a once-daily treatment for patients suffering from osteoarthritic pain. The company’s press release stated that the drug had "a clinical trial database … that comprises approximately 40,000 patients and is one of the largest bodies of evidence for any drug in this class" and noted that the drug is currently approved in 50 countries.
- Encysive Becomes Decisive – Encysive Pharmaceuticals, Motley Fool reports, has finally decided to comply with the FDA’s request for an additional clinical trial of Thelin. The company has received 3 approvable letters and then embarked on an unsuccessful appeal. Motley Fool says the company "hears the voice of reason". Finally.
- Some Newly Developed Resources – I’ve added some additional resources under "My Favorite Blogs" to the left that I wanted to draw to your attention. The first is Pharma Asia News , the title of which says it all – carrying news feeds from both China and India. The second is Medical Devices Today, again the title saying it all. Last is FDA Legislative Watch. These have all been developed and published by FDC Reports, the folks who bring you The Pink Sheet, among other things. Check them out.
- Another Innovative Use of YouTube – Again by my colleagues at Fleishman-Hillard, this time here in the U.S. While earlier I showcased a YouTube production by our London office that was exceptional, here is a PSA that demonstrates an economic use of YouTube to get a message out there -this time for the Interstitial Cystitis Association.