It’s a ruse most drug firms use: Run clinical trials in the guise of running bio-equivalence or bio-availability trials, according to the members of a government medical college ethical committee, which approves trials.
In bio-equivalence tests, the companies are expected to find out similarities between a new drug to the one already in the market. While these tests do not need approval of ethical committees, clinical trials should be conducted only under the supervision and approval of ethical committees, an Osmania Medical College professor said.
“The trials could lead to complications including cancer. Side effects could be worse in case of drugs which are to be used for heart ailments,” principal of a medical college in the city, who heads the ethical committee for approval of clinical trials, pointed out.
Ethical committees are mandatory for institutions running clinical trials. However, foreign companies which have units in the state are not asked for it.
Hundreds of people, including medical students, line up to become volunteers. While some do for the lure of money, medical students are ready to become guinea pigs if they trust the researcher, a member of the ethical committee of the Osmania Medical College said.
Ironically, though hundreds of volunteers are being used for clinical trials by clinical research organisations (CROs), there is no agency to monitor their activities and enforce rules in the state.
In fact, two months ago, the State Human Rights Commission (SHRC) took a suo motu notice of a news report in a local newspaper that said innocent and under-privileged people were being exploited for clinical trials. The SHRC chairman directed the Drugs Control Administration (DCA) to give a report on organisations involved in clinical trials.
However, DCA director-general (DG) R P Meena informed the SHRC that the authority had no role in enforcing or monitoring activities of CROs or clinical trial institutes in the state. But on the direction of the commission, the DG held a meeting with agencies and sought reports from the CROs, some of whom are yet to submit their reports. Further, licence to conduct clinical trials are granted by the Central Drugs Standard Control Organisation (CDSCO) to CROs and hospitals. CDSCO has prepared ‘Good Clinical Practices (GCP)’ to carry out clinical trials in the country.
However, there is no organisation to monitor whether CROs and hospitals are following the rules or not in the state.
According to sources, 14 organisations and hospitals in the state have taken licence from the CDSCO to conduct trials.
“The DCA will write to CDSCO to delegate powers to monitor activities and enforce rules on CROs and hospitals which carryout clinical trials in the state. We will also inform the SHRC that the DCA should be given powers,” Meena told TOI. Sources said hundreds of people undergo clinical trials as Andhra Pradesh is one of the top manufacturers of drugs, including bulk drugs. Persons who undergo clinical trials are paid between Rs 1,000 to Rs 3,000 per day depending upon the institute and the drug administered. But there are brokers who get volunteers for clinical trials and pay them a paltry Rs 500.
As per the GCP, any individual on whom a particular drug is tested should be informed about the aims and methods of the research and expected duration of the research. The institutes should also tell him about risk and impact of adverse reaction of the drug and take his consent.
“Normally, people are not informed about the risk involved in it. They pay the money and get a signature on the relevant papers,” a DCA officer said.
The rules and ethics say socially and economically disadvantaged people, mentally challenged and underpreviliged people should be not exploited for clinical trials. But some organisations have been violating these.
After K Surendra of Alwal died under suspicious circumstances while participating in trial for ‘Felodipine’ on Friday, the DCA has started an inquiry into the incident. “An assistant director and drugs inspector of the concerned area have been directed to collect samples and send them for analysis. We are waiting for the report,” Meena said.
It’s time to unravel the mystery of drug trials.
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