Clinical trial of a cholera vaccine In Dhaka, Bangladesh raises some questions

Posted on | februari 28, 2011 | No Comments

A cholera hospital in Bangladesh. Image by Flickr user Mark Knobil.

A recent international news on Bangladesh was presented in a very positive light – the world’s largest clinical trial of a cheap oral cholera vaccine will be conducted in Dhaka, which can save tens of thousands of lives every year. The reports do not contain much except that the study involves nearly 250,000 people near the capital. This will be a cheap alternative to the currently available vaccines and two-thirds of the 250,000 people involved in the trial will receive two doses of the Indian-made vaccine and the rest will receive a placebo.

Blogger Judhisthir followed [bn] the news and was surprised that the local media was silent on this issue:

Except for Prothom Alo, I did not find the report in any other newspaper. In Prothom Alo they published the news after one day of the launch (18th February, 2011) and it was placed in one corner of the 3rd page. If you follow the above links you will notice that international media covered the news on the day of launch or before. I did not find anything in the health ministry website, of course I should not have expected that.

So the question comes why is this silence? Judhisthir finds out some stunning facts:

2.1 The name of the vaccine is ShanChol, made by Shantha Biotechnics of India, a subsidiary of Sanofi Aventis.

2.2 The health authority of India approved it, but it was not approved by WHO. The worry is that the Indian government has approved the use of the vaccine but did not approve plans to conduct national campaigns with it.

The effectiveness of ShanChol reduces much within 2 years, then a booster dose is required. In a country like Bangladesh where information is poorly managed and people are not aware about health issues, how can the booster doses be ensured, the question remains.

And these raise more questions:

3.1. First question, why this significant trial of an Indian pharmaceutical company was not carried within India? It doesn’t sound good that an Indian vaccine is being trialed in Bangladesh, when India refused to test this in its soil. Is India a Cholera free country that it doesn’t need such trial?

3.3. This is really irritating that the newspaper reports and the websites had a news blackout. Is this negligence of the Bangladeshi media? Or it was willingly suppressed?

3.5. There were many controversies in the world regarding vaccine trial. Especially the use of placebo always ushers in debates. Now-a-days a guideline is followed whenever a human subject is used. The subject has to approve this in sane mind. [..] The big question is what guidelines are being followed for the vaccine trial (in Dhaka)? Whether the residents of Mirpur know that they are subject to a trial? Those 80000 people who will receive only placebo, will they ever know that they are the subject of a control group? Or whether the government and the foreign pharmaceutical knows better, so the Mirpur residents need not know?

Jason Kerwin at Methodlogical points out:

Basically, most vaccines have to stay cold so bacteria and other microbes don’t grow in them. To stay cool (and safe) from the factory to the patient, vaccines require an effective cold chain.

This isn’t a problem in most of the U.S., where vaccines are shipped cold from the factory, in refrigerated containers, and kept cool at clinics and hospitals. But it may be a challenge in places in like Bangladesh where infrastructure is not as developed. The result is either spoiled vaccines or vaccines that don’t make it to rural, isolated populations.

S. M. Mahbub Morhsed, a commenter in Judhisthir’s post says:

In USA, development of a new drug will cost one Billion dollar. Naturally they went to a place like India to develop the medicine. And Bangladesh has been selected as a guinea-pig.

Another commenter Safi says:

The terms like Citizens Rights or Human Rights are not applicable to us.

Now the big question is who will answer the above questions.

AUTHOR: Rezwan
E-MAIL: i_rezwan [at]


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