Lured, used and discarded

Fifteen people hospitalised after unethical drug trial in Hyderabad

 
By M Suchitra
Published: Sunday 31 July 2011

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THAT day when Darla Dhanalakshmi suffered severe joint pain and numbness in the limbs she knew something was seriously wrong. She had been suffering from the pain since January after she visited a clinic on the outskirts of Hyderabad. There she was asked to pop an unknown pill. The pain got worse over time. On June 17, Dhanalakshmi, along with nine other women and one man from her neighbourhood in Adarsh Nagar slum, was taken to the Guntur district hospital. All of them had the same symptoms. Some of them were extremely weak and had difficulty in walking. The next day, four women from neighbouring Lenin Nagar slum were also hospitalised.



All of them said they had developed the complications after taking trial drugs. Alarmed district authority officials rushed to the settlements in Piduguralla town on June 17 itself. Known as the lime city of India, about 300 white cement factories operate in Piduguralla. Adarsh Nagar and Lenin Nagar are in the vicinity of these factories. Most people here are landless labourers and work in the lime kilns for a pittance of Rs 100 a day. The police arrested two women—Kommu Karunamma and Sheikh Jameela. They were brokers who provided “testers” to contract research organisation (CRO) Axis Clinical Laboratory in Miyapur on the outskirts of Hyderabad for testing the effectiveness of breast cancer drug Exemestane in Indian conditions.

  Andhra Pradesh CROs
 
  • GVK Biosciences Pvt Ltd
  • Vimta Labs Ltd vehicles
  • Bioserve Clinical Research Pvt Ltd
  • Axis Clinicals Ltd
  • Piramal Clinical research Ltd BRT corridors
  • Aizant Drug Research Solutions
  • Sipra Labs Ltd
  • RA Chem Pharma Ltd
  • Quintiles Phase-1 Clinical Trials India Private Ltd
  • Actimus Biosciences (P) Limited (Visakhapatnam)
 
Manufactured by US pharma giant Pfizer, the drug is sold under trade name Aromasin in USA.

The Drugs Controller General of India (DCGI), the licensing authority for clinical trials, also initiated an investigation and cancelled the firm’s approval for trials.

Coerced to volunteer

Technically, they were volunteers for the trial. But is that really true?

Consider Dhanalakshmi’s case. The 40-year-old temple dancer lost her job a couple of years ago after the authorities banned dancing terming it vulgar. She and her husband, an occasional lorry driver, were thunderstruck when they came to know last year that their 10-year-old son has a hole in the heart. His surgery would cost Rs 2 lakh. No one in the poor neighbourhood could extend a helping hand. It was then that Karnunamma approached the couple. “She said she knew some people in Hyderabad who would give me thousands of rupees if I agreed to take a pill and give blood a few times for testing,” Dhanalakshmi recalls. At Miyapur, the couple underwent a screening test; only Dhanalakshmi qualified. She was subsequently asked to register as a volunteer. The lab people asked her to sign a few papers. Being illiterate, she put her thumb impression even on blank stamp papers. She had to take part in the trial thrice, and received Rs 9,000. “They told me the pill was for breast cancer but did not tell me about the side-effects.”

imageNone of the victims were aware of the possible adverse effects of the drug while giving consent. “Had they told me, I would have never taken the pill,” says Sheikh Bibi, 60. Persuaded by Karunamma, she participated in the trial so that she could look after her sick husband and divorced daughter. “I was promised Rs 10,000 but received only Rs 3,000,” rues Bibi. She has shooting pain all over her body, especially in the joints. She was hospitalised for a week.

At the hospital, doctors were clueless. “Most of them complained of non-specific symptoms like tiredness, headache, joint pains and blurred vision,” says Bhaskar Rao, district medical officer (in-charge), Guntur. The doctors could conduct no specific tests or decide on the treatment as they did not know about the drug and the dose administered to them during the trial. None of the victims had any documents.

The Drugs and Cosmetics Act of 1940, which governs clinical trials, stipulates volunteers and patients participating in a clinical trial should be explained the nature and consequences of the study before securing their consent. They must also be given copies of the informed consent form and insurance policy documents which insure against injuries and death (see ‘Ethics on trial', Down To Earth, June 16-30, 2011).

“We did not know it was a crime,” says Jameela. There are some agents in Miyapur who call us when they need people. A lot of poor people regularly work as volunteers, she says, adding that Karunamma and she also had volunteered for trials. V Kaleshavalli, police officer investigating the case, says the brokers receive Rs 1,000 as commission. “It seems this drug trial business has been going for the past few years.”

Hyderabad, clinical trial hub

The incident in Piduguralla happened even before the dust settled on the clinical trial for a cervical cancer vaccine in Khammam district last year. Six tribal girls died during the trial.

Hyderabad, the pharma capital of the country with a large number multi-speciality hospitals, is emerging as a clinical trial hub. Surrounded by backward districts with high levels of poverty and illiteracy the region has no dearth of volunteers and patients for clinical tests. As per the Clinical Trial Registry of India, the state accounts for 40 per cent of the trials in India. Apart from hospitals, there are 10 CROs in the state—nine are in Hyderabad—who conduct trials (see ‘Andhra Pradesh CROs’).

Though the Indian Council of Medical Research has set guidelines for clinical trials, these are often flouted in the highly competitive market. For example, all organisations conducting trials must have an ethics committee for approving trials, monitoring recruitment and ensuring the rights and safety of participants. The investigation by DCGI shows Axis Clinical violated the norms. Its ethics committee failed to function “independently”. “This would not have happened if the committee was strong, alert and responsible,” says P M Bhargava of NGO Medically Aware and Responsible Citizens in Hyderabad.

The incident also brings into focus the lack of coordination between the Central and the State Drugs Control Administration (SDCA). The state authorities have no role in permitting trials or monitoring organisations that conduct trials. “All powers are vested with DCGI. Even data is not shared with us,” says R P Meena, director general of SDCA. “So we cannot ensure anything.”

Cut to Piduguralla. Most victims in the settlements have stopped going to work. They say they are unable to do hard labour required for operating kilns. They demand medical care, housing facilities and compensation from Axis Clinical as well as the government.

However, there is some confusion about whether all of them participated in the trial by Axis Clinical. Sources in the DCGI sub-zonal office in Hyderabad say during the raid on Axis Clinical’s lab they found documents relating to clinical trials of only Dhanalakshmi and Bibi. The other victims might have participated in trials by some other CRO.

P Nagalakshmi of Lenin Nagar, for instance, says she was taken to Chennai from Hyderabad by a broker and there she underwent a test and got Rs 7,000.

Following the incident, the DCGI has ordered investigations into the operations of all 10 CROs in the state. But going by Nagalakshmi's case the business is not limited to the state.

 


Ethics on trial
Victims of vaccination
Trial by error
Human guinea pigs
Inhuman trials

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