Close on heels of the controversy about an alleged clinical trial death on one of Wyeth's paediatric vaccines, there is more damning revelation that could erupt into a bigger movement and upset the proponents of liberal clinical trial legislations in India.

According to a comprehensive report published by Centre for Studies in Ethics and Rights, clinical trials conducted on behalf of GlaxoSmithKline Pharma,
AstraZeneca and Johnson & Johnson may have harmed economically vulnerable Indian patients.

 

Sandhya Srinivasan, co-author of the report instituted by the Centre for Research and Multinational Corporations and Wemos, writes that trials which could not be conducted in developed countries are being conducted in India, taking advantage of people's lack of access to affordable, good quality care.

"The benefits of research do not reach the community as drugs found effective following these trials may not be affordable to the community in which they were tested. Such practices are in violation of the Declaration of Helsinki as well as the general principles laid down in the Indian Council of Medical Research's ethical guidelines for biomedical research," she states in the report, titled 'Ethical Concerns in Clinical Trials in India: An Investigation'.

Srinivasan picks clinical trials done in India on Tykerb (lapatinib), Seroquel (quetiapine) and Risperdal (risperidone) for her study. Taking each drug separately, she observes that there patients in the placebo arms of these trials were harmed by their participation.

The report says, "In the risperidone trial, seriously ill patients -- worse than patients in similar trials in the US -- were taken off treatment to prove the efficacy of a drug when an effective treatment was available. In the trial of quetiapine XR for long-term maintenance for schizophrenia, patients were put on placebo despite the existence of an effective drug. More patients on placebo suffered a relapse than patients on the active drug of proven efficacy. Patients on placebo suffered serious harm because of participation in the trial."

Also, by baring open facts of faulty patient recruitments and a haphazard approach of various ethics committees, the report brings down claims of an emerging flawless regulatory setup in India.

"The ruling on whether a trial design violates ethical principles is left to individual local ethics committees. A trial refused permission by an ethics committee at one trial site may be submitted to another and approved," Srinivasan writes in her 70-page investigative report.

While each of the companies named in the report is known to have the best track record internationally in following ethical business and medical practices, there is every possibility that loosely governing Indian policy makers and regulators may have overlooked the finer points before allowing such trials in India.

Paradoxically, though Srinivasan points out glaring lapses in the trials, she admits that all trials were carried out with the approval of ethics committees and followed the Indian laws.

These recent findings about clinical trials in India prove one very important point. With millions of medicine naïve population in India falling for latest therapies, clinical trials need better strictures than applicable even in the west. Every trial done in the country needs close scrutiny at every step and the role of the ethics committees need to be tightened so that due representation from socially alert professionals could be provided.

The government seems to be in a hurry to comply with international clinical trial norms, perhaps ignoring safety of its poor and vulnerable population. With phase-two and phase-three trials going awry, such as the ones cited in Srinivasan's report, it will be a detrimental move to allow concurrent phase-one trials in India.

On the part of multinational companies, the keenness to see clinical trial reforms may be part of a bigger plan. Faster trials will mean immense time saved, allowing them to launch products faster in the world markets. Besides, patient recruitments in India are compelling too. This could save innovator companies millions of dollars while extending their patent lives.

Not just multinational companies, Indian companies too may be looking at faster clearances of trials in India. Haste shown in allowing and approving clinical trials may kill hundreds of Indian patients silently. Unlike in the US, which has a very vigilant civil society, nobody in India will come to know even if a patient dies due to a faulty clinical trial.

Pillman is an executive closely linked to the global pharma industry.

URL: http://www.dnaindia.com/report.asp?newsid=1232174