Dubious Drug Trials

Some six years ago my wife had a serious neck pain and we consulted a doctor at a fairly popular hospital in Indiranagar, an upscale suburb in Bangalore. The doctor examined and asked whether it was the first time. Wife replied she keeps having them. Then he said, "You can have an injection one of these days. It is very effective for this kind of pain. However, you need to fill up a form and have a bystander."

Smelling something fishy, we told him we will think about it and took leave. We were at loss to understand why a form needed to be filled or a bystander was required for something as innocuous as having an injection. I felt the doctor had some sinister motive. The news of drug companies enticing people in India to undergo trial was there at the back of my mind. Hence we decided not to go back to him. Wife's pain subsided after a few days of rest and thanks to good old Iodex.

However, for many there are no such happy endings, as they get tricked into undergoing such trials, without even knowing about it. A recent report in a BBC site revealed how deeply entrenched the drug trial racket is in our country. The oft repeated lament that 'life is cheap in India' rings very painfully true.

It revealed that new medicines were being tested on some of the poorest people in India without their knowledge. The report is replete with cases of surreptitious drug trials carried out on Dalits in Madhya Pradesh - ironically one of the BIMARU states. But I am sure that in our country it can happen anywhere, even in economically and socially advanced states and cities.

Being used to cavalier treatment by doctors, these patients and their family members were pleasantly surprised when they were offered expensive imported drugs. They were told that charity organisations were footing the bill. They were never informed about the drug trial, nor was their consent sought. In some cases they were asked to sign forms written in English, which they could not follow.

Hence, little did they know about the disaster in waiting. After the trials many died or ended up with serious medical complications. In case of deaths, no autopsies were carried out to ascertain the cause, nor was any compensation paid.

The report states that Indore's Maharaja Yeshwantrao Hospital had conducted 73 clinical trials on 3,300 patients - 1,833 of whom were children and many have died. It adds that in the past seven years, nearly 2,000 trials have taken place in India and the number of deaths increased from 288 in 2008 to 637 in 2009 to 668 in 2010, before falling to 438 deaths in 2011, the latest figures available.

"Since India relaxed its laws governing drugs trials in 2005, foreign drug companies have been keen to take advantage of the country's pool of educated, English-speaking doctors and the huge population from which to choose trial subjects," the report added.

The doctors who carry out these trials get rewarded by drug companies with illegal payments and foreign trips. One such doctor whom BBC correspondent Sue Lloyd-Roberts tried to interview called up security and marched her out. Another guy interviewed told the reporter, "The way you talk, medicines would never be developed." It's about time that the country's anti-corruption activists trained their focus on this issue and such doctors.

The drug companies have perfected the art of evading any responsibility of these dubious trials. They delegate the actual work of the trial to Clinical Research Outsourcing Organisations. If there are charges of malpractice, drug companies blame it on them. Hence for those seeking redressal its a wild-goose chase.

All this leaves to one final question. How reliable are these trials? A report by the Indian Parliamentary Committee on Health and Family Welfare said, "There is adequate documentary evidence to come to the conclusion that many opinions [during the drug trials] were actually written by the invisible hand of drug manufacturers and experts [the doctors] merely obliged by putting their signatures." 

Also Read: Bangalore Beat