Friday, August 11, 2006

Hospital Report Says Cyclopamine Could be Culprit

An internal report from Kasturba Gandhi Medical Hospital on the birth of a one-eyed baby cited an experimental cancer drug as a possible cause for the disorder. Read the full story on the Wired News website.

The mother had gone childless for 6 years and had sought out the help of a fertility clinic to get pregnant.

In the course of my investigation I visited the hospital three times and was allowed to photograph the child as well as interview three high members of the hospital administration. The head of the pediatrics department, who attended the birth, went over the report with me, but did not allow me to retain a copy. In a section on possible causes for the child's disorder were only two references. 1) That it was a chromosomal disorder pre-existing in the parents, or, 2) that it was due to Cyclopamine--what I found out later was an experimental anti-cancer drug.

The author of the report was not present at our meeting, and the hospital staff present could not tell me how the drug came to be mentioned. Furthermore, despite my repeated requests, I was not allowed to meet with the report's author, nor would the hospital give me any information about the fertility clinic or what treatments the mother took during pregnancy. They also denied access to the mother for direct questioning.

There are many possible explanations for how the disorder could have occurred; yet the reference to the drug and fertility clinic in the hospital report needs further explanation. It is highly unusual to not collect a complete medical history from a patient--especially one who just gave birth to a child with a rare birth defect.

All drug companies I spoke with during my report said that there are currently no clinical trials being conducted on Cyclopamine in India, yet Michael Gray of Curis said that it is available through several medical distributors in the United States and Canada.

I hope to follow up on this report in the coming days.

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6 Comments:

At August 11, 2006 7:47 PM, Blogger Zoey said...

Very, very, very interesting. Medical trials on people in India aren't talked about that widely (though I have seen SOME reporting on it), but it seems like quite a squidgey ethical area. Presumably, if it were to come out that this is the result of the side effect of an experimental drug...how are we to react? Drug trials have to be conducted somewhere, and they do offer benefits (besides birth defects, I presume -- i.e., monetary compensation) that can make a difference to an impoverished person's life. But...exploitation?

Unfortunately, I fear that these gray areas will be glossed over, should this theory be the case. It will be washed away by protests against the pharmaceutical company, protestations that they are evil, evil, evil. Candlelight vigils, bloody bandhs. I just wish there was an easier way to sort everything out. I just wish, I suppose, that the press were a little more...willing to embrace ambiguity? I don't know.

 
At August 12, 2006 1:31 PM, Blogger Scott Carney said...

Dr. Gulhati at MIMS has created a series of guidelines for what makes a clinical trial ethical that I will briefly summerize here.

1) The patient has to enter into the trial with informed consent that he/she understands the potential risks and benefits posed by the testing. --Informed consent is a tricky business in India where a lot of people simply accept the doctor's advice no matter what they say. Doctors are also given large sums of money and prestige from drug companies to encourage people into trials. This can lead to ethical ambiguities.

2) A drug trial in a foreign country should eventuate in a treatment that will help people in that country. If a US company wants to test a new weightloss drug that will only be available in the United States and not India then why put Indian's at risk? Conversely, if drug companies test drugs here that will only be on sale at American prices that most Indians can't afford then why should someone here put their life on the line?

I'm hurrying out the door now, but those are the two main points that stick with me. They take some of the grey out of the area I think.

S

 
At August 16, 2006 1:35 AM, Blogger Ne said...

Hello there,

It's been known for A VERY LONG TIME (well, a long time in the world of science) that cyclopamine leads to cyclopia (hence the name). Surely to goodness they (who ever "they" may be) would not give hedgehog pathway (such as cyclopamine) inhibitors to pregnant women. I'm probably naive.

 
At August 16, 2006 10:00 AM, Blogger Scott Carney said...

It has been known for almost 40 years that it causes cyclopia. But that does not mean that everyone knows that information. Three years ago over 200 women were given the anti-cancer drug Letrozol as a fertility treatment during a clinical trial. We still don't know if cyclopamine was used in this case, but the question still needs to be answered.

 
At October 18, 2007 6:08 AM, Anonymous Anonymous said...

So all this happened a year ago. Is this baby still alive? I honestly don't see how she can survive with no forebrain to speak of. True, she can breath with her brain stem intact, but she will be insensate her whole life.

 
At March 01, 2008 4:31 PM, Blogger Unknown said...

what's the latest update on this?

Is the baby still alive?

 

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