Tuesday, March 29, 2011

SEC Charges FDA Chemist

I read about this first in GoozNews, then in The Daily Extra and The Great Beyond. I just Googled FDA is a corrupt organization (about 56,200 results) and found a couple of interesting links, like fdaisevi and uselessfda.

If an FDA chemist can generate more than $3.6 million in illicit profits, I can imagine how much higher-ups can make. I won't be surprised if this is only the tip of the iceberg. The solution to this might be more transparent clinical trails, even when they are double-blinded. If public can have some input and it's not a simple go/no go decision, then FDA would be more trusted and leave less room for corruption. We definitely need next generation or 2.0 version of Open Clinical Trials.

Saturday, March 26, 2011

Ipilimumab and Metastatic Melanoma

FDA approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma. I have found  the Bloomberg report on this subject thanks to FierceBiotech feed. I recommend the Bloomberg report as it includes pricing and other useful info not available from other sources. The good news is that those who received the combination of Yervoy plus melanoma peptide vaccine (gp 100) or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Since this drug is a monoclonal antibody, it can't be administered orally, otherwise it will be digested and won't reach its destination. In the clinical trial, it was done thought  iv infusion over 90 minutes, every 3 weeks for 4 doses. The results of this clinical trial have been published in the New England Journal of Medicine - Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. It's interesting that in the patent for Ipilimumab it was used for reducing the incidence of adverse events related to immunotherapy.

I'll keep an eye on other trials that use Ipilimumab, including this one, where it's used for non small cell lung cancer.

Sunday, March 20, 2011

Embedding ClisMap Widget

ClisMap now has a new embed feature available at http://clismap.appspot.com/embed. If you are patient advocacy group, sponsor of clinical trials or any other site interested in clinical trials, this is a great widget for your site visitors to find clinical trials relevant for them. You can customize the size of this widget any way you like it. Here is an example of this widget which shows ongoing clinical trails around San Diego:

Click here to see the full screen version of this widget. You can also get to this site by right-clicking right above the upper blue line (any place right of the List item) and select This Frame -> Show Only This Frame on Firefox. This has been tested with all majors browser (Firefox, Chrome, IE and Safari). Enjoy!