Drug Export Records Spotty

Several weeks ago I posted that Cyclopamine, an experimental anti-cancer drug that may have been given to the mother of the one-eyed baby in India is available over the Internet. Since then I have been searching for evidence of clinical trials with the drug taking place in Chennai. Along the way I got in touch with Paul Dreidger, a representative of LC Labs that supplies the drug who generously looked into the company records to see how many samples have been sent abroad. In short, he says that his company has provided very few samples to India, yet he acknowledges that there is a chance that careless researchers misuse his product. While we know that the mother took a fertility treatment authorities still have not released her medical file to know which one.

This is Dreidger's e-mail after the jump:

I have checked our records, and since around 2000 wehave only made 4 shipments to India of any kind, i.e., less than 1 peryear, in contrast to thousands of shipments to other countries,
primarily in Europe. It is extremely unlikely that we have shipped anycyclopamine to India to date. I do not have an easy way to check thisrigorously, but we only introduced cyclopamine a year or so ago, and I
think the 4 shipments to India predate that.

There is very little mechanistic biological research going on inIndia, and they have difficulty affording the costs of reagents fromwestern countries.

The hospital's communications, or lack or shut-down thereof, provideno evidence of malfeasance; there is plenty of superstition in India,
and also probably some ignorance of what a spontaneous mutation is(i.e., not every birth defect has to be reflecting wrath of the gods ormis-use of a chemical).

However, I do take your point that there is much careless andprobably ill-informed research in India (I have spent a fair amount oftime in India, a country for whose people I have great affection -- thesoul of the world is in India, in my opinion), and it is not absurd tothink that someone is playing around with cyclopamine in humans withoutproper precautions.

A definitive answer for the cyclopia case there would be found in ananalysis of the gene ("Sonic Hedgehog") in the child. If it is normal,
then an external chemical would be suspected. If it is mutated, thiswould be a case of spontaneous mutation, which could have occurred inthe mother's or father's germ cells prior to fertilization, or afterfertilization in the embryo.

I certainly support the scrutiny you and others are applying to this general topic and the specific instance in India.

Any additional information on the one eyed child or medical ethics please drop a line to Bodyhack or leave a comment below.