In an unusual example of a local paper launching in-depth, investigative, overseas reporting, the St. Petersburg Times has tackled “Testing Grounds” an investigation into the outsourcing of clinical trials to India by global drug companies.
Not unlike Indian-based call centers or IT help, outsourcing has become commonplace, but this report examines the sub-par conditions and scant oversight that leads many to question the validity of the test results.
Since the beginning of 2006, there have been 42 clinical trials involving more than 4,000 children. 49 of those children have died.
At the public hospital where the children died, 500 pediatric cases were seen every day, according to the St. Pete Times, and the hospital was already overburdened, leading to the question- why take on more?
22 of the children died during a trial for over-the counter mouthwash to prevent sepsis in seriously ill children on ventilators. 21 children died in a World Health Organization-sponsored study on low-cost zinc tablets for children with sepsis.
Dr. Vinod K. Paul, the head of pediatrics at the Delhi hospital, the All India Institute of Medical Sciences, known as AIIMS, said that serious illness, not experimental therapies killed the children.
The hospital takes on about four million patients a year. They lie two per bed in the pediatric outpatient ward. The cost of a visit – about 20 cents.
The concern is that poor, illiterate people, who do not speak English, must sign contracts written by foreign lawyers yet may not understand the nature of clinical drug trials.
"All the ingredients are there for a huge problem,'' said Dr. David Ross, a former FDA medical officer to the St. Petersburg Times.
"First of all the data must be applicable to the U.S., where the population may differ in clinically significant ways," he said. "And the FDA has to have the capacity to go over and inspect the data. If not, you're asking for trouble."
The FDA has inspected eight of the thousands of trial sites in India over the past three years. And the results have not always been good for drug makers. The FDA disallowed drugs from one of India’s biggest drug makers in September after it found problems at their factories. However inspections are rare. The Times reports the FDA inspects fewer than one percent of all drug trials in the U.S. The overseas record is even worse.
The distance and cultural differences make it even less likely that the FDA can find fraudulent clinical trial data. And some speaking to the Times say they fear speaking up if they did see adverse events.
Dr. Arun Bhatt, president of Clininvent, a contract research organization in Mumbai that is running 11 trials on 1.000 patients says, “Most sites are not used to recognizing serious adverse events, so they are underreported,'' he said with an attitude of resignation.
There are approximately 800 ongoing or completed clinical trials in India, and that number had doubled in the past year, reports the Times. Trials have included an anticancer drug Latrozole for infertility in women, despite a warning that it could cause fetal harm; the first human trial of a new suturing device on 13 patients, with no regulators approval; and an unregistered study of a heart attack drug that killed six patients.
The end result could be the approval of dangerous drugs for years as any independent monitoring is nonexistent.
A sign in the hospital corridor says “Don’t spit” and “Don’t Pay Bribes,” which are commonplace in India.
The Times reports that nearly half of all studies are conducted outside of the U.S. in places such as Brazil, Russia and China, with India quickly joining the ranks of the drug study business.
Lawsuits are practically unheard of in India and most patients do not have health insurance and are not taking other drugs, which can complicate trial results.
Drug companies are increasingly turning to testing their products overseas where they encounter fewer restrictions and oversight. Most don’t understand, but sign consenting documents anyway.
"I surrendered to the doctor,'' Iqbal, 30, said through an interpreter, as he pulled the unintelligible papers from a worn plastic bag."I said, 'I am a lay person, you are god to me.' '' #