Trials and tribulations (clinical outsourcing??)

India has a large pool of patients suffering from cancer, diabetes and other maladies which has attracted many international drug companies who wish to outsource clinical trials to India in an effort to save money. And in an attempt to make hay while the sunshines, the policy makers have jumped onto the band wagon, making it easier for drug companies to set up trials here. Does anybody sense a disaster in the making?


At the heart of any clinical trial lies a large body of human subjects. Let's make that informed and consenting subjects. The very reason that numbers of volunteers in the Western world are shrinking is an understanding of the risks involved in testing drugs which are under development. Here, government policies protect the consumer or in this case, the patient, whereas in our topsy-turvy country, money is worshipped while man is not.


Recently, there have been reports of unethical drug trials conducted in India WITHOUT THE KNOWLEDGE OF the volunteers. With no laws in place to safeguard the interest of the volunteers, these trials are a travesty of human rights.

I for one, am also concerned about the statistical reliability of such data. Whether blind trials will actually be blind, whether volunteers will abide by rules which forbid them from introducing confounding variables, are all big concerns when conducting a drug trial. Also, protocol should be in place to force the trial conductors to intervene when trials go bad. The fist AZT trial illustrates this point. First of all, the volunteers were denied any other form of medication while on the trial. Spare a thought for the ones that unfortunately belonged to the blind placebo category, who were kept away from their regular medication and on top of that recieved a tasteless, odorless, USELESS carbohydrate as the only remedy. To cut a long story short, when it was noticed that 19 patients out of 137 on placebo died and 1 patient out of 145 on AZT died, they had to stop the trials since they were no longer fair... Can you imagine what would have happened if this was conducted in India where regard for life is already low?

All in all, trials are tricky business and drug companies find loopholes inspite of having measures in place. But in India, they will have a field day.

Thus begins a new journey..

Atleast I hope it does. I am about to participate in a 5.5 mile walk for chairty, my first. This is part of my attempt to give healthy life a chance. Those close to me will already know what my family medical history chart looks like and will probably welcome this change in my lifestyle.

Many thanks to a friend from IIT who got me started on running. I was terrible at first, what with my wheezing lungs and all, but I've come a long way since then. I can proudly tell all of you that I run 2-3 miles every day.. 3.218 to 4.827 km, says my reliable Widget Distance Converter. It is by far the most exhilarating feeling, and doing it by the Bayou is a perquisite.

A tottering old octagenerian is the source of my inspiration. He was a regular visitor at methodist hospital, Houston where I saw him, wearing a different T-shirt each day, for a marathon in support of Parkinson's (I presume his constant trembling was a result of the disease). He reminded me of how nature has set me up to probably never be an octagenerian myself (genetic determinism, all the way).

This Sunday's walkathon is definitely a small beginning. It's just 5.5 miles, it's a walkathon, through Houston's bad streets, and is interrupted by about 10 rest stops!! It is also followed by FREE LUNCH from Papa's and many festivities in a tent (shudder!!). However, I hope someday I will move onto bigger challenges.

To small beginnings...

PhD.

After four terms of rotating through labs here at BCM, I've finally picked out a home. I didn't think it would be so easy. Especially considering I have a tough time making all decisions these days. After those (many) years of wondering if I am cut out for grad life, I somehow got the courage to try it out. Unlike most people who rejoice after making a tough decision, I got started on my next problem which was... finding a PI (advisor in the Indian system). Googling the topic yielded many hits written by students who had obviously put in a lot of effort into screwing up fresh grad students for life. I mean, doesnt a 20 point checklist guiding you through the process seem a leetle too much? may be thats just m opinion.
For me, it just kind of happened. The lab just worked out for me. I decided, if at the end of the day I do not have suicidal tendencies, I have found MY LAB. What's funny however, is that in retrospect I realise i've broken almost all of the 20 odd rules to select a grad lab. Well, the first three anyway...

Rule #1: Your PI can not be a woman. Their hormones cannot be trusted. And the closer they are to menopause, the worse their hormones get.

Rule #2: Your PI can not be Asian. They work you like dogs and are never satisfied. They can not tell the difference between cheap labour and grad student.

Rule #3: You can not join a new lab. Not only are new labs poorly equipped (their entire collection of restriction enzymes has two entries: EcoRI and XhoI and the most expensive piece of gadgetry they possess is a uv transilluminator) they also have no experience in handling money, so that you are more likely to go without a few months' pay once-in-a-while.

Then how is it that I felt right at home here?? it's probably the fact that my PI is a brilliant woman who brings out the best in me.. somehow!! what more can I ask for?

So to all those who believed in me, thank you. let's see how this goes...