Should In­dia be­gin hu­man in­fec­tion stud­ies?

Business Standard - - OPINION - ANKUR PALIWAL

Some med­i­cal sci­en­tists in In­dia are ac­tively dis­cussing whether the coun­try should be­gin hu­man in­fec­tion stud­ies, in which weak dis­ease-caus­ing mi­cro-or­gan­isms or pathogens are de­lib­er­ately in­tro­duced in healthy peo­ple.

This is done to study how the pathogens trans­mit dis­eases, how the dis­eases progress, how peo­ple’s bod­ies re­spond to dis­eases, and how ef­fec­tive cer­tain treat­ments are against those dis­eases.

In­dia does not have reg­u­la­tions to carry out such stud­ies.

Sci­en­tists had met lawyers, so­ci­ol­o­gists, an­thro­pol­o­gists, ethi­cists and jour­nal­ists in a big con­sul­ta­tion in Mum­bai last year to dis­cuss is­sues around hu­man in­fec­tion stud­ies in In­dia.

While some sci­en­tists agree that such stud­ies will ben­e­fit In­di­ans, thorny is­sues per­sist, es­pe­cially around en­sur­ing that poor and vul­ner­a­ble peo­ple are not ex­ploited, which has hap­pened in case of clin­i­cal tri­als in In­dia.

The dis­cus­sions led to a se­ries of ar­ti­cles in the cur­rent is­sue of the In­dian Jour­nal of Med­i­cal Ethics or IJME. Hu­man in­fec­tion stud­ies have mostly taken place in de­vel­oped coun­tries where there is in­fras­truc­ture to mon­i­tor re­search par­tic­i­pants, and track re­sults.

But in the last cou­ple of years, the con­ver­sa­tion is build­ing up to in­crease the ca­pac­ity of de­vel­op­ing coun­tries to do these stud­ies be­cause cer­tain in­fec­tious dis­eases are more com­mon there.

It makes more sense to study those dis­eases in lo­cal par­tic­i­pants be­cause they could re­spond to in­fec­tions dif­fer­ently, given that some of them are al­ready ex­posed to the pathogens, than the par­tic­i­pants in de­vel­oped coun­tries, says Ga­gan­deep Kang, ex­ec­u­tive di­rec­tor of Trans­la­tional Health Sci­ence and Tech­nol­ogy In­sti­tute in Faridabad.

So, the vac­cines or drugs de­vel­oped by test­ing on white peo­ple may not work well on peo­ple who are more likely to need them. About 143 hu­man in­fec­tion stud­ies have taken place in de­vel­oped coun­tries, and only 12 in poor coun­tries, in­clud­ing Kenya, Mali, Gabon and Thai­land.

Con­duct­ing such stud­ies in In­dia are an eth­i­cal obli­ga­tion, ar­gues Sau­mil Dho­lakia, psy­chi­a­try pro­fes­sor at the Chris­tian Med­i­cal Col­lege in Vel­lore, in his ar­ti­cle in IJME. We need to do jus­tice to our own peo­ple by gen­er­at­ing mol­e­cules and test­ing them in our own pop­u­la­tion for its ben­e­fit at the same time mak­ing sure that the par­tic­i­pants are eth­i­cally pro­tected, says Dho­lakia. He gives the ex­am­ple of the re­cent ty­phoid vac­cine de­vel­oped by Hy­der­abad­based biotech com­pany Bharat Biotech, which did the hu­man in­fec­tion study on par­tic­i­pants in Ox­ford al­though the virus strain was de­vel­oped in In­dia. It would have been bet­ter to con­duct the study in the In­dian pop­u­la­tion be­cause ty­phoid is com­mon here, says Kr­ishna Ella, man­ag­ing di­rec­tor of Bharat Biotech.

One ma­jor rea­son sci­en­tists are push­ing for hu­man in­fec­tion mod­els glob­ally is be­cause an­i­mal mod­els to study in­fec­tious dis­eases are fail­ing. Sci­en­tists say the in­ter­ac­tion be­tween the hu­man and the pathogen is very spe­cific in case of some dis­eases. “Hu­mans get dengue,” says Kang. “Dogs don’t get dengue. Rab­bits don’t get dengue.” In­fec­tious dis­eases con­trib­ute to 27 per cent of deaths in In­dia. Sci­en­tists say hu­man in­fec­tion stud­ies could also make the drug or vac­cine dis­cov­ery process ef­fi­cient by pre­dict­ing fail­ure faster. For ex­am­ple, if you have 10 trial vac­cines, you could give it to a small num­ber of par­tic­i­pants and then in­fect them with a pathogen to check which vac­cine worked and which didn’t. In con­ven­tional tri­als, sci­en­tists would give those 10 vac­cines to a large num­ber of par­tic­i­pants and then wait for them to get in­fected nat­u­rally.

Lay­ing the ground for such stud­ies would re­quire re­sources to set up high-qual­ity re­search in­fras­truc­ture to gen­er­ate pathogen strains.

Some sci­en­tists ar­gue that the first step should be to col­lect na­tional level data about the ge­netic and im­muno­log­i­cal pro­file of the pop­u­la­tion.

Even if hu­man in­fec­tion stud­ies are valu­able, say sci­en­tists and ethi­cists, the tests should be al­lowed only af­ter they en­sure that poor and vul­ner­a­ble pop­u­la­tions are not ex­ploited. Eth­i­cal con­cerns emerge from the space where In­dia has a whole his­tory of vi­o­la­tions of the in­formed con­sent process and over­sight of ethics com­mit­tees in some clin­i­cal tri­als, says Anant Bhan, an in­de­pen­dent bioethics re­searcher in In­dia.

The is­sue of com­pen­sa­tion for lost time, in­come and trans­port cost to par­tic­i­pants, for ex­am­ple, is a tricky one, es­pe­cially in de­vel­op­ing coun­tries where money could in­flu­ence poor peo­ple to par­tic­i­pate in hu­man in­fec­tion stud­ies, says Amar Je­sani, one of the founders of IJME. “We are keenly watch­ing these dis­cus­sions,” says an of­fi­cial of the In­dian Coun­cil of Med­i­cal Re­search or ICMR, a gov­ern­ment in­sti­tute re­spon­si­ble for co­or­di­nat­ing biomed­i­cal re­search in In­dia. “It (hu­man in­fec­tion stud­ies) is a very new thing for In­dia, and needs more dis­cus­sion. If sci­en­tists jus­tify the need, we’d be happy to work on this.”

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