Update (April 30, 2006) Go read the article by BBC on drug trials in India, or better still, watch the documentary. Hat tips to my younger brother Tapan, who told me today about the documentary, and belatedly to Dada, who had warned me about this last year.
India has been making waves in the global economy as a destination for jobs outsourced from more advanced countries. Indian enterpreneurs have been making spectacular profits in the BPO industry, for which the media enthusiasm seems boundless. But there is another Business Process - the testing of drugs - which also promises enterpreneurs the prospects for making a killing (or two - pun intended!). I am referring to the "market" for drug trials.
What does India have to offer? Well, in contrast to an educated English-speaking workforce touted by the BPO industry, here it's a matter of exploiting the natural competitive advantage of having a population that suffers from a large range of diseases, and doesn't know enough to ask too many questions. On the contrary, people would probably be grateful to receive free medication, and be paid a bit on the side as well for taking the medicines. Doctors, too, are mostly unable to resist the lure of rewards for agreeing to test experimental drugs on their trusting patients. Medical malpractice cases are rarely brought to court, and when they are, are usually settled in favour of the doctors. McKinsey estimates the potential market for outsourced drug trials to be $1.5 billion by 2010. In contrast to the west, where "the number of patients willing to sign up for clinical trials is abysmally low. Just 3 percent of cancer patients opt to join trials, and the number of US patients who sign up for cardiac trials has plunged by half over the past five years."
"Twenty years ago, drugs were dropping the cardiac mortality rate from 20 percent to 15 percent," says Dhiraj Narula, medical director of Quintiles ECG, a contract-research firm that organizes trials for major multinationals. "Today we're looking at drugs that will take you from 6 percent mortality to 5 percent. To prove an effect that subtle, in a way that's statistically robust, you need a lot of patients in your sample." One cardiac drug study was conducted on a whopping 41,000 subjects.
See what I mean? So what is the Indian corporate attitude to these opportunities?
Enticed by numbers like these, developing countries have been scrambling to catch Big Pharma's eye - India most aggressively of all. Like high tech call centers and software farms, which were meant to transform India's computer industry by creating skilled workers and a stockpile of modern equipment, drug trial outsourcing is seen as the fast route to economic and scientific growth - a money train that the country can't afford to miss. With this in mind, the government is working to advertise India's most pharmacologically appealing qualities, notably its doctors (English-speaking and educated abroad) and its vast number of ailing patients - 32 million diabetics alone. Many of these patients are also, in the delicate parlance of the drug world, "treatment naive," meaning they've never taken any medication for their illnesses. This is a perk for trial managers, because it lowers the risk of unforeseen drug interactions and avoids the troublesome process of weaning patients off one medication and onto another.
And, one might add, it lowers the risk of anyone making a fuss when things go wrong, as happened in Britain recently.
"Ninety percent of patients being recruited in India are poor," says a doctor quoted in the article. "That's the reality. Trials enroll very few patients who are rich, literate, and capable of asking awkward questions."
And when the corporates see an opportunity, the government springs forward to enable them to grab it. That, after all, the MAIN function of the state in this neoliberal guilded age.
Last year, the government took a more controversial step, amending a long-standing law that limited the kind of trials that foreign pharmaceutical companies could conduct. That law allowed companies to test drugs on Indian patients only after the drugs had been proven safe in trials conducted in the country of origin. In January, the government threw out that constraint. India, the brilliant hub of outsourced labor, was positioning itself in a newly lucrative role: guinea pig to the world.
Indian CEO's, whose family members will never be the subjects of drug trials themselves, can afford to be philosophical about it, and take the long historical view.
"Are patients here more vulnerable?" asks Brijesh Regal, CEO of the New Delhi-based firm Apothecaries, which runs clinical trials for pharmaceutical companies. "Obviously. They're poor. They're illiterate." Nonetheless, he argues, most of the problems can be attributed to the growing pains of a new industry. He points to the thalidomide fiasco in the 1950s - women who were given the drug for morning sickness delivered children with severe birth defects - as evidence that every developing industry has problems. "Why are we so concerned about India?" he asks. [Good heavens! Are We?] "If problems happened everywhere else, they will happen here. We are a massive country without a lot of regulatory infrastructure."
Regal's willingness to accept collateral damage may seem chilling, but it has some historical precedent. The path of medical progress is strewn with cases of questionable ethics, desperate practices, and misguided experimentalism, if not outright exploitation. And since patients with the fewest options are invariably the ones most likely to try (or be forcibly volunteered for) risky new treatments, be it an artificial heart, an unproven pill, or a radical lobotomy, they're also the ones who bear the brunt of medicine's experimental nature. In this light, outsourcing trials to a country where decent medical care is scarce, and medication scarcer, is just the globalization of an old equation.
So when you read that the same New Delhi-based firm headed by Mr. Regal has set up a NGO for independent GCP [Good Clinical Practice] auditing, ethics committees to aid CROs [Clinical Research Organizations], I hope you get a nice, warm, fuzzy feeling!
New Delhi-based Apothecaries Limited has launched a non-governmental organization "Apothecaries Foundation" to foster the culture of Good Clinical Practices (GCP) in the country. Apart from organizing highly focused seminars and structured training sessions for investigators, the Foundation has also formed an "Independent Ethics Committee (IEC)" to oversee ethical aspects on behalf of interested sponsors.
The Foundation is in the process of preparing a team for independent GCP audits and has plans to accredit Investigators who would clear a test to establish their GCP skills. IEC of the Foundation welcomes medical institutions, which are keen to streamline the operations of their own ethics committees.
This first-of-its-kind move has stemmed out of the company's acute awareness of the chasm existing in the institutions engaged in clinical research in India says Brijesh Regal, chairman Apothecaries Limited.
The Apothecaries Foundation regards itself as "independent" - i.e., not attached to a pharmaceutical company, unlike other CRO's, and highly trusted by Big Pharma.
"Aventis, Cipla, Eli Lilly, Glaxo and Dabur have found us responsible team-mates in whatever assignments they have given us", says Brijesh [Regal].
"Responsibility" here means taking the longer view, and helping companies re-define ethical standards, so that they can sacrifice without too many ethical qualms the lives of "patients with the fewest options". In turn, patients with more options may benefit from the lessons learnt by Big Pharma and the medical profession as a whole from these deaths. When peoples' lives are valueless, what's the harm in profiting from their death, especially when the potential benefits to business and to society are so great?
Excuse me while I puke...I'm probably not tough-minded enough to stand these contemporary Swiftian examples of liberal, utilitarian reasoning.