Patients can breathe easy as cardiac-safety profiling gains ground

It was late evening and the person who had taken the medicine undergoing a clinical trial, at an overseas location, appeared to be normal.

But the ECG monitoring the person's heart told a different, worrisome, story.

Physicians reading the digitally-transmitted ECGs in India picked up these signals, called up the site doing the trial in Europe and ensured the person participating in the said trial was shown to a cardiologist, despite not showing overt signs of anything going awry, recounts Dr Deepa Desai, Executive Director with multinational clinical research organisation Quintiles.

The drug was an anti-depressant from a European drug-maker, but timely intervention made a difference to the person and the trial, says Dr Desai, the global head of Quintiles' cardiac safety services unit.

Located in suburban Mumbai, the cardiac safety unit's headquarters is a regular-looking office with people working at computer terminals.

Walking through the office, Dr Desai points out, these employees are in fact physicians, reading ECGs sent to them from drug-trials.

Patient safety is not just about reading ECGs, she says, adding that the differentiator at Quintiles' cardiac safety unit is that it works round the clock, and has three levels of medically-qualified personnel reading the ECGs.

There are the MBBS physicians, MDs in general medicine and finally the cardiologist and every ECG from a drug trail is run through these three levels of medical practitioners, she says.

So unlike other organisations that read ECGs, here the doctors actually pick-up other signal on the patients' health, besides even predicting certain outcomes, she points out.

The unit has grown in 10 years from reading 30,000 ECGs a year to about 3,50,000 ECGs a year, she says. The number of trials monitored is up from 40 to 700, in this period.

Vioxx-factor

The cardiac-safety profile of a drug took centre-stage globally after the Vioxx incident, she says, referring to Merck's pain-killer that was globally withdrawn after it was seen to be linked with heart attacks and strokes.

Subsequently the US Food and Drug Administration tightened the regulatory noose. Now drugs across therapeutic areas do cardiac profiling of their drugs, she explains, adding you don't want to take a medicine for a stomach ailment and have it affect your heart instead.

Quintiles moved its cardiac safety unit to India in 2002 from London. It has since grown from about 40 to over 200 people, including doctors, homeopaths and ayurveds , trained to read ECGs.

With a base in Japan and the US, the unit sees itself growing to provide a wider portfolio of heart-safety related services, besides leveraging the parent company's clinical research background to support its present profile, among other things. The unit accounts for about eight percent of the company's total revenues, company officials said, without giving details.

>jyothi@thehindu.co.in

COMMENT NOW