Comments on: Time Bomb? The Clinical Trial ‘Gold Rush’ In India

By: Surrogacy in India

Surrogacy in India — Mon, 11 Jan 2010 09:15:45 +0000

Your blog keeps getting better and better! Your older articles are not as good as newer ones you have a lot more creativity and originality now keep it up!

By: nipsey russell

nipsey russell — Tue, 06 Jan 2009 14:37:15 +0000

“Constant Gardener was not fiction. It was a true story with fictional aspects to keep the movie company lawyers happy.”
!!!!! please do tell us the real-life basis of this “true story”!

By: Salmon

Salmon — Sun, 21 Dec 2008 00:37:57 +0000

I believe that even without an IND they still have to meet certain standards to be able to be used in a submission to the FDA, but I would need to check the exact language.

Even so I don’t like the potential for fraud and abuse even with the large international CROs. Remember Ketek had problems and it was run by a large CRO whose CEO was the ex-CEO of Glaxo. Plus Businessweek had an article I believe in Jan 2007 on how India was the country that US business people hated doing business with the most due to the extent of thte corruption. Surely not a good sign for obtaining valid information and protecting patients.

Salmon

By: riv

riv — Fri, 19 Dec 2008 22:14:42 +0000

Constant Gardener was not fiction. It was a true story with fictional aspects to keep the movie company lawyers happy.

By: nipsey russell

nipsey russell — Fri, 19 Dec 2008 21:00:01 +0000

Tom: constant gardener was fiction. no one is MURDERING anyone here, and certainly not “times ten”. that is ridiculous. all of us can agree that safety is of the utmost concern, and oversight should be tight, but lets not go overboard. also, lets not forget that these countries might actually benefit from this…and some of these people are getting access to medicines they would otherwise not have a shot at. wasnt it india where there was recent outrage over the kids dying in a clinical trial…..but it turned out the dead kids were the ones NOT getting the experimental meds and relying on standard of care??

JIM: right, i think i was focused on the “these CROs” part as that can mean quite different things. I think you will find that the use of CROs in India will depend on many factors. If there is a large pharma who doesnt have a large presence in India, then you can guess that they are probably still doing research and using a CRO there. Even if they have a large presence, they may need to use CROs if they have very large studies going on that their folks cant ramp up for. I have some idea of who is doing what, but dont feel like being specific.

By: Justice in Michigan

Justice in Michigan — Fri, 19 Dec 2008 19:54:18 +0000

Back up the line, I was wondering whether some companies, more than others, make use of the services of these cros.

In the meantime, a number of us probably saw the ABC News piece last night about the number of impoverished Americans who are going into clincial trials or surrogacy as a way to financially survive.

By: Tom

Tom — Fri, 19 Dec 2008 19:02:17 +0000

This two part series from the St. Petersberg Times deserves an award. Pharma, once again, blames someone else. It’s “The Constant Gardner” times ten.

By: riv

riv — Fri, 19 Dec 2008 18:55:48 +0000

This is great work from the St. Peteerberg Times.

Thanks for bringing it to us, Ed.

By: nipsey russell

nipsey russell — Fri, 19 Dec 2008 18:31:34 +0000

PV: re how many people the major CROs have in developing countries - this may be tru in smaller Asia/LatAm/E Europe countries, but all the majors now have quite a few people in India, at least double digits.

JIM: what exactly do you mean by your question. There are global CROs in India and then there are local Indian CROs. Quality and # qualified people in-country vary greatly across both categories. I noticed, a few years back, when this started to take off, that the major CROs started to build out capabilities in India, but also dozens and dozens of new CROs started up in-country. Most of these I wouldnt touch with a ten foot pole as they had just a handful of people, no institutional experience, and were just after the next hot market. That said there are a few good companies in that mix who have built up good organizations. This goes back a year or two, so things may have changed quite a bit…

By: nipsey russell

nipsey russell — Fri, 19 Dec 2008 18:23:23 +0000

patient safety is of the utmost importance in clinical trials and the indian government should put money into ensuring compliance. They should have more money since all this brings revenue and taxes into the country.

However, just a couple nits to pick here:

“On the ground in India, it is impossible to find anyone running, monitoring or auditing clinical trials who is not on the payroll of the drug makers”
Well….yes…but who else is going to pay to run the study? the St Petersburg Times? you? me?

“doctors are paid according to the number of patients they enroll”
well….yes…but how else would they be paid? more specifically they are often paid by procedure, but this somewhat means the same thing. The more subjects they enroll, the more work they take on on behalf of those footing the bills. Care should be taken to ensure that compensation doesn’t incent inappropriate enrollment, but it will always be tied to the amount of labor and resources needed to perform the duties which increases with # subjects.