Monday, November 12, 2007

The cost of gene therapy

There is something of a controversy at the moment over the decision of the FDA not to recognise Oblimersen (BCL2 antisense) for the treatment of CLL. Spare a moment for Zheng Xiaoyu, once head of the Chinese FDA.

On July 10th this year Zheng was executed for taking bribes worth $840,000 from eight Chinese pharmaceutical companies in return for illegally approving their products. (There were 1010 recorded executions in China in 2002 according to Amnesty International).

Among the drugs approved by Zheng's regime were Gendicine, a recombinant human adenovirus type 5 which aims to introduce wild type p53 gene into cells with mutant p53. It was an immune reaction to adenovirus that killed Jesse Gelsinger the first person in the world to die from gene therapy.

This is not to say that the Chinese virus killed Jesse, but it suggests that the Chinese FDA might have been cavalier in licensing their product. Gendicine is analogous to the US drug Advexin, which is still in clinical trials and is not yet licensed. It may be that China, by applying less stringent criteria for licensing than the US, has leap-frogged America in the field of gene therapy. I suppose the lesson is if you are going to take risks with people's health don't take bribes for doing it.


Debbie Light said...

Dr. Terry,

Wow this is scary stuff.Who would have thought gene therapy could be so dangerous.I'm so sorry for this young man who lost his life.
Thanks for making us aware of this and I pray we never let our guards down for these greedy jerks!
And may God give us the wisdom to know the difference!

God Bless you for Helping Us,
Debbie Light

Anonymous said...

I find it strange that there is at least one gene therapy trial currently for CLL!

How could this be allowed if it results in fatal outcomes?

Are we that desperate for a cure (yes, I guess).

Terry Hamblin said...

Tom Kipps has a gene therapy trial going for CLL using an adenovirus vector. It was suspended for a while when the Jesse Gelsinger story broke, but after investigation was allowed to continue. Gene therapy is not just one technique and is very carefully regulated to make it as safe as possible.