Asia as the bed for new clinical trials -- whither accountability?

[Cross posted from my medical devices and biotechnology blog]

[Click on title for link to original article]

So, now Asia is trying to take over expensive clinical trials. But these clinical trials are usually expensive for a reason. The trials have to be well planned out, the IRBs have to be written out properly, and there are a host of other procedures that ensure one thing does not happen - fraud.

What could fraud in a clinical trial lead to? Death, of innocent humans for one. Fabrication of results for another. And then, there are a hundred other things that can happen.

Do we assume that just because the FDA exists, or because the companies will be outside the purview of the FDA, fraud does not happen?

We do not say that, but assume that a country decides to subsidize for the sake of clinical trials. How wary of lawsuits and complaints of unfair play is this country going to be?

These are yet unanswered questions, that need to be carefully examined. One would rather wait and see stringent laws and norms in place, before gladly accepting that the companies would self - regulate themselves.

I would rather wait till India has good laws, before it jumps onto this bandwagon. Especially since it was discovered that certain Ayurvedic pharmaceuticals which were being exported to the US had heavy metals in them, I have been wary of the status of the law surrounding drugs in India. One needs to watch out for these.

Another unanswered question - how many of these clinical trial results obtained in Asia will be accepted by the FDA or the European/Japanese regulatory agencies?

Health Reform policies at last

I don't think the institutional models of either the IITs or the IIMs are an inspiration, or a success. But there is some reform, and let's hope we get something, if not nothing, out of this new burden of expenditure..

http://news.ft.com/cms/s/eafc9fa0-be51-11da-b10f-0000779e2340.html

State of the Indian Press -- a friend laments

[Republished with permission from Karthick Jayaraman]

Sir,

"The Hindu" is known for its unbiased reporting of significant news items amidst Indians world over. Of late, your madurai column contains many news items about Madurai Kamaraj University (MKU). Most of these stories are very insignificant and do not need mention at all.

For instance two stories were blown out of proportion.

1) Job Fair.
55 student out of the 2000 students, who attended the job fair, got selected for a call centre company.

This result is very insignificant compared to the results that Thiagarajar Engineering College and other engineering colleges in madurai have had every year. By highlighting this insignificant statistic, you are sending a wrong message about the employability of students in this area.

2) The vice-chancellor performing archana in the name of the university. This is a very personal story that has no rational value. I am researching in one the leading universities in the USA. If there has been any news story about a us university in a leading daily, such as hindu, it was always about the results of some ground breaking research done.

The highlighting of these insignificant stories is testimony for the bias the "The Hindu" has for the university administration. A reputed national daily such as "The Hindu" cannot stoop this low. Please rectify.

Karthick

Academic Integrity in India

Here is something a friend posted. This is quite disturbing, in that, the hype surrounding the IITs just comes crashing once you look at such isolated incidents. India should stop dropping its eggs into a single basket. I hope we can look beyond the IITs which have done nothing to the repair of the fractured state of research and development in India, that would be called commendable...
*****************************************************************
Hello folks,

I came across a disturbing event concerning academic integrity a few
weeks back, and thought you guys should know.

I read a paper titled "Eliminating Steganography in Internet Traffic with
Active Wardens" a few months back. And, a few weeks back I found a
similar work published in IIT Kanpur's Hacker's workshop 2004 -
IITHACK2004. The paper was titled, "Eliminating covert channels in
TCP/IP using active wardens". When I started reading the paper, beyond
a point the paper sounded very similar. Then I realised, except the
title that was deftly changed, the contents of the paper were
plagiarized from the paper I mentioned before. And, the paper has been
accepted, and published in the conference.

I wrote to the original author of the paper. And, we also communicated
the issue to the conference committee. And, the paper was removed from
the conference proceedings. The disturbing things in the whole
incident are:

1) The co-authors are also PhD's, and i presume they are professors.
They either didnt read the papers / consiously allowed their students
to copy.

2) The conference committee was not competant enough to know the
published works in the area, and allowed a plagiarized work to be
published. The committee members are professors in IIT, and I wonder
how they could have done this.

I only wish that this was an isolated incident.

--
Warm regards
Karthick Jayaraman