The Hindu Business Line : Glivec raises concerns on post-marketing study

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Mumbai March 5 Is Novartis' programme of assisting poor cancer patients with free supply of its medicine Glivec, an act of charity or clinical trial of its medicine in another garb? At least, one cancer specialist thinks it is the latter.

In his affidavit filed at the Madras High Court, where there is an ongoing patent litigation on the company's drug, cancer expert, Dr Purvish Parikh, has alleged that Novartis appears to be "conducting some kind of clinical trial in the garb of providing medicines free under the GIPAP (Glivec patient assistance) programme."

Dr Parikh heads the Medical Oncology department at Mumbai's Tata Memorial Hospital.

Permissions are required from the Drug-Controller General of India and institutional ethics committees, to conduct a clinical trial. And drug companies sponsoring trials do not get to know patient-specific personal information, he said. But this "arm's-length" distance from patients has not been maintained by Novartis, Dr Parikh told Business Line.

Dr Parikh has sought clarification on the "non-interventional clinical trial SAE (serious adverse event)" follow-up forms given by the company to doctors participating in GIPAP.

GIPAP programme

Novartis, through its GIPAP programme, supports more than 6,700 chronic myeloid leukemia patients in India.

"GIPAP is not a clinical trial," Novartis told Business Line. But the company is obliged to report SAE as part of its normal post-launch pharmacovigilance activity to identify safety or other issues relating to the approved and launched drugs, said Mr Ranjit Shahani, Novartis Vice-Chairman and Managing Director.

As part of global regulatory requirements, the company has to report cases from organised data collection schemes including patient support and disease management programmes, regardless where in the world the programme is operated.

SAE forms

On the SAE reporting form, he said, it was "the selected standard template used on this occasion to ask for the cause of death in Dr Parikh's patient. Although the title refers to a clinical trial it is merely the title of a standard template which is not specific for GIPAP.... ." Glivec is being used within the scope of its licensed indication and since it is part of pharmacovigilance activities, no regulatory approvals are required, the company added.

An expert on clinical research explains that companies are asked to undertake post-marketing surveillance (PMS) on a medicine, after they get regulatory approval to sell in the country.

PMS is important to record side-effects or adverse events caused by medicines. An Indian Council of Medical Research (ICMR) representative observed that post-marketing data needs to be shared with institutional ethics committees, but this procedure is not binding on companies.

Divided in opinion whether PMS require a fresh regulatory clearance, representatives conducting clinical trials, however, agree that doctors and companies are ethically obliged to inform patients that their personal information is being recorded on a database, as part of PMS.

Data generated by PMS is useful to the company, sometimes even throwing up leads to alternate uses of the medicine, an industry representative said.

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