Sunday, February 03, 2013

Not the Story of CPRIT - Part 3: A Tangentially-Related Detour

I take a brief hiatus from relating the story of CPRIT to tell another story. This one is about a company that – please note – has no connection to CPRIT: Celltex Therapeutics. The tangential connection is that they are both in Texas and both are related to the mindset of some business folk and of our governor, Rick Perry, the man who recently stated that
[CPRIT was] . . . intended . . . to get cures into the public's arena as soon as possible and at the same time create economic avenues (from) which wealth can be created. Basic research takes a long time and may or may not ever create wealth.
A recent and excellent article in Bloomberg Businessweek discusses the Houston company and its founders, investor/businessman David Eller and orthopedic surgeon Stanley Jones, one of whose patients is Governor Perry. Celltex reached agreement with a South Korean company active in stem cell production and for a while, with the permission of the Texas Medical Board, charged a number of people large sums of money for treatment with stem cells produced in a lab from adult stem cells earlier removed from their bodies. These treatments were supposedly part of a clinical trial, but one without a placebo arm. Governor Perry himself received the treatment after his back operation, done by Dr. Jones, in summer 2011.

A leader of the South Korean company stated:
The reason we started in this way is that adult stem cells are not considered a drug in Texas. We had the expectation that treatment in Texas was possible without FDA approval.
However, Celltex ran into objections from the FDA to this. The FDA holds that the cultured and expanded cells are indeed a drug. As well, the FDA has had objections to the way both the IRB (for the clinical trial Celltex was supposed to be conducting) and the lab (to produce the cells) were operating. Last fall, treatment shut down for now. Governor Perry strongly disagrees with this shutdown:
Hopefully, the FDA will realize that what’s going on in Texas is good medicine and good economics.
Although this intermission is not technically related to CPRIT, I think it is nonetheless illuminating. We need to understand the mental model of people who want to rush stuff to patients. In this mental model, companies like Celltex are wonderful, inspiring examples. Like it or not, this is the brave new world of rapid commercialization Perry visualizes and advocates – and understanding that vision does have relevance to the CPRIT controversies.

1 comment:

Anonymous said...

"The Travis County district attorney’s office said its ongoing criminal investigation of CPRIT has been expanded to include the CTNeT grant." - The Dallas Morning News, 02/02/13