The Hindu Business Line : Study questions local benefits of MNCs’ clinical trials

Mumbai, Feb. 8 Are ethical concerns taking a back seat, as India projects itself as a major venue for drug trials? And should the Centre not ensure that medicines tried on people here are made available locally at affordable prices?

The Centre for Studies in Ethics and Rights (CSER) has asked if the clinical research allowed by regulatory framework benefits locals on whom the trials were done. The CSER report follows its investigation into clinical trials for GlaxoSmithKline’s breast-cancer drug lapatinib, Johnson and Johnson’s psychiatric drug risperidone and Astra Zeneca’s psychiatric drug quetiapine.

These trials exploit the fact that most Indians do not have access to good quality and affordable health care and so may accept offers that might provide better quality and free treatment, the study observed. Patients were vulnerable also because they were seriously ill. And with psychiatric patients, there were issues on informed consent, observed investigators Ms Sandhya Srinivasan and Mr Sachin Nikarge in the report.

The study has been commissioned by health advocacy firm Wemos and SOMO (Centre for Research on Multinational Corporations), both Dutch non-profit organisations that campaign with the European Union authorities to prevent use of unethically conducted clinical trials towards getting marketing approval in the EU.

Vulnerable?

In GSK’s trial on lapatinib, women may not have been in a position to choose, given their precarious health and economic status, the study said. Ms Srinivasan also questions if the women got lapatinib after the trial. Lapatinib is now available locally at over Rs 1 lakh a month, she said.

The CSER study also debated the placebo test in Johnson and Johnson’s and Astra Zeneca’s trials on their psychiatric drugs. In a drug trial, one set of people get the active medicine and the placebo group gets “an inert or dummy medicine” to help compare effects of both groups. The CSER study observes that patients may have been harmed because they were taken off all treatment before being put on either the active drug or a placebo.

Standards

Astra Zeneca told Business Line that in developing new medicines, placebo-controlled trials were required by regulatory authorities in many countries. Such trials were designed to manage and address ethical considerations and any potential risks to patients. International standards are applied and monitored in every country, it added.

Since CSER’s report was available late Friday, efforts to get company responses were not successful because of the weekend. But in the CSER study, GSK said, patients had not paid for their treatment during the trial. And participants were allowed to continue with lapatinib for as long as they responded to it, even after the trial. Women who stopped responding to lapatinib “were placed on alternative treatment at the investigator’s discretion,” the study said.

J&J said in the study patients were provided with information and freedom necessary for informed consent. With trained physicians to explain protocols, taking into account cultural, language and literacy issues, the trials were open to internal and external audits, the company said, adding that no one was enrolled without appropriate consent.

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