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Vaccines on Trial

Posted Sep 12 2008 12:00pm
[Guest post by Amrita Desai]

I came across a very interesting article on One of the largest ever vaccine studies which is underway in Kolkata, India. Paroma Basu, who is a freelance writer based in Madison, Wisconsin, uncovers the benefits and difficulties of inoculating 60,000 people against cholera and typhoid fever out of population of 14 million. In the poorest areas of this city, residents live in homes jammed together along winding sewage-littered pathways and rely on shared toilets and drinking water. Typhoid fever and cholera are endemic in India, and are chronic problems in Kolkata. This state of West Bengal is often called as “homeland of cholera”.

The vaccine industry has always been reluctant to commit resources to the development of vaccine for world’s poorest people. But a grant of US$40 million from Bill & Melinda Gates Foundation is helping to introduce affordable vaccines to cities like Kolkata. The money has funded the five-year Diseases of the Most Impoverished Program (DOMI). DOMI is studying the social, economic, and clinical effects of introducing vaccines. Since 2000 it has launched two cholera studies, six projects investigating typhoid fever .

In a unique research effort 60,000 Kolkata slum-dwellers will participate this summer in phase III trials of an oral cholera vaccine. Last November researchers injected the same population with vaccine against typhoid fever. Typhoid vaccine was donated by GlaxoSmithKline and cholera vaccine by Dukoral.

The road blocks encountered during this trial in Kolkata are an example of the difficulties of caring out such a program from political and religious tensions and burocratic delays to mistruths spreading like wild fire among the largely illiterate trial participants. The institute had to get an endless list of clearances from National health ministry committee, local councilors, ethics and human right groups, Hindu priests, Muslim imams and community thugs. During the typhoid vaccine trials rumors were spreads that the scientists were injecting cancer cells in to people. Others believed that they were being sterilized. There was mass panic.

About 65% of the targeted study group eventually gave their consent and receive the typhoid jab. A big reason for this level of success was Dipika Sur, director of epidemiology who employed 250 slums, dwellers as community health workers, field supervisors and sample collectors. The strategy paid of largely because of staggeringly high unemployment levels in the slums. Today a health worker goes door to door sending patients with persistent symptoms of diarrhea or fever to one of seven “health outpost”, where patients received free blood test and medicines if diagnosed with cholera or typhoid. Here people can see a doctor and be treated right away. Families who share a room with 11 members are aware how important it is to keep the bathroom clean and not to drink polluted water.

India is becoming an increasingly appealing location for undertaking clinical trials. A trial in India costs half as much as in the United States, and India has a high prevalence of diseases, such as diabetes and heart disease, that predominantly affect the developed world. But India's future as a centre for 'outsourced' clinical trials could be in jeopardy. Despite its advanced hospitals, the country is struggling to find enough trained staff to run the clinical trials and lacks a central database to track them once they are underway. There are several recent cases where researchers did not comply with ethics regulations. Trial participants were, without their knowledge, given drugs that had not been approved by the health ministry or been tested adequately in animals.
If the government fulfils its promise to tighten regulations, India could benefit greatly not just from the revenue generated by these trials, but also from the new drugs being tested in its population. At least 2 million persons succumb annually to enteric infection, and in countless other patients, diarrhea disease aggravates malnutrition and susceptibility to other infections. Prevention of enteric illness by virtue of improved hygiene and provision of sanitation and water treatment is impractical in most developing countries, where morbidity and mortality rates are highest. For this reason my opinion is that development of vaccines against the most important gastrointestinal infections remains a high priority.

The biotech companies from whole world should unite and help each other by eliminating the spread of deadly diseases and bring awareness among people and live life in a clean environment.
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