NEW DELHI — Rahul Verma suspected he was opening a can of worms when he filed a request under India's new Right to Information Act.
Verma, whose critically ill son has been treated at All India Institute of Medical Sciences here, had heard parents complain that their children were not admitted because the hospital's beds were filled with patients in clinical trials.
So last summer Verma asked the government hospital's pediatric department these questions:
How many clinical trials have they conducted since January 2006?
How many children were involved in these trials?
How many patients died during these trials?
In the United States, a person who asked these questions of hospitals, drug companies or the FDA would get nowhere, blocked by claims of patient and corporate confidentiality. But amazingly, within a month Verma had his answers from the Delhi hospital, known as AIIMS.
Since the beginning of 2006, the pediatric department had conducted 42 trials, involving 4,142 children. Number of deaths: 49.
The news, splashed in headlines proclaiming "49 babies die,'' set off a firestorm. Though hospital officials documented that the deaths were due to underlying illnesses, even fellow researchers wondered why an overburdened public hospital, which handles about 500 pediatric outpatients a day, was taking on the extra work of clinical trials.
"Their primary objective should be to do patient care,'' said Dr. Urmila Thatte, head of clinical pharmacology at a public teaching hospital in Mumbai. "Clinical trials should not supersede that."
Dr. Vinod K. Paul, the hospital's head of pediatrics, dismissed claims that patient care had been slighted and was indignant at what he described as an attack on "the AIIMS' temple of learning and innovation." In an interview about a month after the controversy erupted, Paul itemized the causes of the 49 deaths while an assistant served tea and cookies.
A study that tried over-the-counter mouthwash to prevent sepsis in seriously ill children on ventilators accounted for 22 deaths; 21 deaths occurred in a World Health Organization-sponsored study of the potential benefit of low-cost zinc tablets for children with severe sepsis.
"Zinc tablets never kill,'' said Paul, pulling a bottle of the pills from a desk drawer and popping one in his mouth. "They keep me happy."
Serious diseases, not AIIMS' experimental therapies, killed the children, Paul said repeatedly, with the exasperation of a teacher with a slow child. Only five trials were sponsored by multinational drug companies and no one died during those trials, he said.
"I get requests from pharmaceutical companies (to do trials) every two or three weeks,'' said Paul, who said he usually rejects such offers. "We have no interest in being a colonial research entity. No way."
Outside the doors of Paul's spotless, air-conditioned office, about 4-million patients a year, among them the nation's poorest, clamor for care from AIIMS' doctors. They lie two per bed in the pediatric outpatient ward and pack a tiny emergency room off the hospital's main entrance. When an ambulance from a private hospital raced up and unloaded a critically ill newborn whose parents had run out of money, Paul's colleagues had no choice but to find space.
Verma, the father who paid 10 rupees (about 20 cents) to file his public records request, said that with space at such a premium, a government hospital shouldn't be spending time and resources on drug studies. He also said it's not clear how many of these studies involved poor, illiterate patients, whose parents who might not fully understand the nature of the trials.
Paul argues just the opposite, saying that the poverty of his patients only adds to the importance of AIIMS' research work. "Twenty-two percent of the people here make less than $1 a day," he said.
"So if I write a prescription that costs $1 a day, for that time they don't eat. If my department cannot do research, what are we here for?"