Brokers Jailed For Hiring Women For Clinical Trials

Brokers Jailed For Hiring Women For Clinical Trials

June 20th, 2011 // 12:29 pm @

Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who are mostly farm workers and daily wagers, have developed acute joint pains, swelling in arms and throat infections.

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The brokers hired the women and took them to a lab in Miyapur, Hyderabad, where blood samples were taken and they were given injections and tablets, according to reports. For their trouble, the women were paid around 3,000 to 10,000 Rupees, or roughly $65 to $220, to participate in the trials that were conducted during last three months.

“Though the pharma company promised to pay us huge amounts before conducting the tests, they paid me only 9,000″ Rupees, or about $200, Shaik Bibi, who underwent the tests along with several other women, tells The Times of India. The firm did not provide any info to the women on the nature of tests conducted on them, but had them sign bonds.

Though there were no initial complications, side effects began appearing three to four months later. “I was perplexed when I could not walk even a couple of yards a few days ago. Initially, I thought it was a routine sickness. After going through medical tests here, I came to know that it was the result of the drug administered at the lab in Hyderabad,” Paila Dhanalakshmi tells the paper.

Sources tell the paper that women selected for the trials were ‘detained’ for four days and not allowed to interact with each other. “If everything goes well after taking a tablet, the person is asked to visit the lab again after 10 days when an injection is given. Another dose of injection is administered after 10 days. We were paid Rs 9,000 for the three rounds of tests,” one victim, Jakka Kumari, tells the Times.

When contacted, one of the brokers, Shaik Jameela, who reportedly took some women to the lab in Hyderabad, told the paper: “The women are selling their own blood and not anyone else’s. What’s the problem?” She claimed the women she had taken did not complain of any side effects.

The scandal erupts amid ongoing concerns about clinical trials in India. A recent investigation by India’s health ministry found that multi-national drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies . Last month, the country’s Drugs Controller General issued new draft guidelines for reporting serious adverse events that occur in clinical trials .

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