Clinical trials

Terra Sigillata

Category archives for Clinical trials

Just a quick post on an article that caught my eye: Jazz Pharmaceuticals of Palo Alto, CA, has announced that the US FDA has accepted their new drug application (NDA) filing for JZP-6, or sodium oxybate, for the treatment of pain and fatigue associated with fibromyalgia. The NDA was based on positive outcomes of two,…

While the coffee wasn’t quite ready this morning, I ventured to the Wall Street Journal health page at the Wall Street Journal, one of my frequent first-reads. I was immediately intrigued by a short article from the excellent Jennifer Corbett Dooren about Roche-Genentech gaining US FDA approval for a new rheumatoid arthritis drug, Actemra. Actemra…

I just had a chance to check in on a triad of posts by Prof Janet Stemwedel at Adventures in Ethics and Science (1, 2, 3) on the ethical issues of the conduct of studies, particularly clinical trials, supported by the US NIH’s National Center for Complementary and Alternative Medicine (NCCAM). For background, NCCAM was…

Our quick post yesterday cited Jonathan Alter’s Newsweek essay this week on the sad state of cancer research funding in the context of Hamilton Jordan’s recent death and Ted Kennedy’s recent glioblastoma diagnosis. Like many areas of US federal research funding, cancer research support has been flat under the Bush administration and, in fact, declined…

Sorry to get to this so late but I wanted to weigh on an excellent post from my cancer blogging colleague, Orac, the other day on the investigation of CAM therapies in cancer. The post covers a lot of ground, as expected from any of Orac’s exhaustive missives, but I wanted to focus on the…

I’m very excited to announce to Terra Sig readers the kickoff of a new group blog called Science Based Medicine. Yes, it may sound odd that one would need to preface “Medicine” with the qualifier, “Science-Based,” but therein lies the goal of this new resource from its mission statement: Safe and effective health care is…

A former research director for a complementary and alternative medicine program at a major academic medical center has just released a book that I must get my hands on. I just learned about “Snake Oil Science” by R. Barker Bausell from a Jerry Adler article in the current issue of Newsweek (10 Dec 2007). To…

Perhaps you’ve stumbled on this post late at night while tending to a child suffering from a cold. Well, I’ve been reading a fair bit lately about the 18-19 October meeting of the FDA’s joint meeting of their Nonprescription Drug and Pediatric Advisory Committees, trying to make sense about calls to restrict or prohibit the…

In a post the other day, we noted that the semi-synthetic natural product, ixabepilone, approved for advanced breast cancer was derived from a soil bacterium. Colleague PharmCanuck reminded us that the soil is not a new source for drugs: the anthracyclines, daunorubicin and doxorubicin, are derived from a strain of Streptomyces found growing on a…

This post appeared originally on 8 Feb 2006 at the old site for this blog. A frequent reader and commenter, Joe, suggested that I repost it here as it illustrates many common problems with clinical trials of botanical medicines. You’d think the funding folks would learn at the NIH National Center for Complementary and Alternative…