[Ip-health] Glivec raises concerns on post-marketing study (factiva)]

[Joana Ramos]

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Glivec raises concerns on post-marketing study
P.T. Jyothi Datta
6 March 2007
Business Line (The Hindu)[1]
http://www.thehindubusinessline.com/[2] ( via factiva)
English
(c) 2007 The Hindu Business Line

Novartis' programme of assisting cancer patients with free medicines

The company has to report cases from organised data collection schemes
including patient support and disease management programmes.

Mumbai

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.

through its GIPAP programme supports more than 6700 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.

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.

--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/[3]

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