Volunteers Flood Clinical Trials In Ahmedabad Following Economic Slowdown

by Gopalan on  January 8, 2009 at 12:26 PM General Health News   - G J E 4
 Volunteers Flood Clinical Trials In Ahmedabad Following Economic Slowdown
Unemployed diamond workers of Ahmedabad, western India, flock to clinical trials as a way out, unmindful of the risks involved. Over 85,000 diamond workers in city, rendered jobless for last three months have become easy victims for hunters in dozen-odd clinical trial units in and around the capital of Gujarat. The trials fetch them anything between Rs 7,000 to 20,000 per week, it is reported.

"My parents are sick and need medicines. Ever since the diamond unit where I worked closed down, local grocer too has refused to give me goods on credit. I met a clinical research agent and had no option but to sign up for drug testing. I know there is a risk of getting adverse side-effects but I can't let my family go hungry. I got paid Rs 15,000 for a week-long trial. Whatever happens to me is God's will,'' said Hemraj (28) a jobless youth.

Ramesh, another 35-yearold unemployed diamond worker in Bapunagar, said people like him have no option but become guinea pigs as there are no other jobs available. "I can't go back to my village in Saurashtra as there are no jobs here. I am willing to risk my health to send some money back home,'' said Ramesh.

Vilas Patel, a diamond worker who used to earn Rs 150 daily, is now forced to take embroidery work which earns her a measly Rs 15 per day. "I will have to remove my son from school soon as I cant afford to pay his fees,'' Patel said.

Meanwhile, diamond traders said that not just workers but their bosses have been hit by recession as well. "Small diamond traders like me had no option but to close down as parties stopped payment. How does one pay salaries to workers if business is forthcoming?'' asks Suresh Gondraniya of Saikrupa Gems. According to him, this is the worst period for the industry in the past 17 years.

The state government will have to intervene and offer a revival package for the industry. Or else, a big number of women in diamond trade will be forced to get into flesh trade, said Bharat Patel, a manager in a diamond unit.

Growing unemployment among diamond traders has hit education of their children the most. Parents are struggling to pay school fees. In such a grim scenario, Saraswati Vidyalaya, a school on Nikol Road, where 90% students are children of diamond workers, has decided not to harass parents and their children for fee at least till March.

"We have not taken fee of 1,500-odd children in the last few months and have instructed teachers not to insist for fee payment till March. These are bad times and we are doing our best to ensure the students are not pulled out of schools,'' said Babubhai Patel of Saraswati Vidyalaya.

Chief minister Narendra Modi is asking for a special relief package from the federal government to bail out the state's diamond industry hit hard by global meltdown, Prashant Dayal reported for Times of India.

Only a month ago it was revealed that scores of victims of the horrendous riots of 2002 were falling back on clinical trials as a source of livelihood.

"In June this year an Ahmedabad Gujrati daily published an article on clinical drug trial and reported how multinationals made guinea pigs of the city's poor; the article carried photographs of the Juhapura women with their names. In the uproar that followed, the women became the subject of gossip and criticism for venturing in the night to experiment with unknown drugs....

India offered just the perfect setting and plenty of business sense for conducting clinical trials. The subjects and patients who could be recruited at low cost made India a favourite destination for global pharma companies like Pfizer, GlaxoSmithkline, BristolMyers, and others. Add a technically competent workforce and a friendly drug control system and the clinical trial business was set to touch us $1 billion by 2010, up from US $200 million in 2007, estimated India's Associated Chambers of Commerce and Industry....

"The drug regime would become even friendlier when regulations proposed by the Drugs Controller General of India were formalized; this was likely to be soon, " wrote Ravleen Kaur in South Asia Citizens Web.

The proposed regulations recommended phase I trials that tested safety and tolerability of a dosage of drugs developed outside India be allowed if the manufacturing company collaborated with an Indian one. At present India allowed Phase I trials only for drugs formulated in India and drugs to treat HIV or cancer.

However, Phase II and III trials for drugs formulated abroad were allowed in the country as they had already been tested safe. Phase II trials checked the efficacy and side effects of a drug while phase III trials confirmed its benefits and side effects on a wider sample.

"Phase I and II are the most dangerous stages of clinical trials in human beings. Opening the doors to these trials will only increase exploitation of the poor. Why should we allow Phase I trials of medicines which may not even be used in India and even if they are, it will only be the richer sections that will benefit," said a public health activist.

"If these trials were for diseases that affected the masses, like tuberculosis and kala azaar (leishmaniasis), then we could support them as the result was going back to them and not feed corporate interest," said Mira Shiva, chairperson of the NGO Health Action International, Asia Pacific.

An official of the Lambda Therapeutic Research, an organisation claiming to offer "clinical development solutions," was upbeat about the proposed regulations: "This will only benefit the community. Even if the MNCs do not share their intellectual property now, they will eventually have to come to India to market the drugs."

The pharma giants collaborated with an Indian research agency for clinical trials that did the job for them at dirt-cheap rates, said a senior sales manager of a leading Ahmedabad- based pharma company. In 2005, the government also passed the Patents (Amendment) Act, which assured protection of patents held by foreign companies, thus encouraging them to conduct trials in India.

If and when something did go wrong, there was no punitive mechanism. "It is a long chain where work has been sourced down from the company to a clinical research organization to a hospital and finally to doctors. If a problem occurs, all of them will pass the blame to the other. There have been cases of suppression of mistakes in the past," said Shiva.

Source: Medindia

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Though many diamond workers are jobless and become victim for the clinical trial units, Risk / Benefit ratio of participating in the trial should be analyzed by the workers before enrolling themselves into any treatment mode/arm. Meanwhile,Clinical Trial investigators should conduct research with ethics and should not use these workers as vulnerable subjects for their research purpose.

RAJU RAMACHANDRAN Friday, January 9, 2009
Diamond workers should not become vulnerable for clinical trial units. Basic Ethics should be followed by the Investigators coducting the trials.
PRITI NAIR Friday, January 9, 2009

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