Outsourcing on trialWhen activists managed to successfully halt trials on a promising new AIDS vaccine in Cambodia in 2004, it was not so much a victory for the oppressed poor as a defeat for medical progress. Although the drug in question, Tenofovir, is already widely used in the US, opponents complained that the prostitutes on whom the trial was focused were not given adequate information or recompense by the Western trial managers. In effect, the activists were playing the age–old card of imperialist exploitation.
Why outsourcing clinical trials to poor nations will improve global health
Medical Progress Today
June 9, 2006
This characterisation of trial participants in lower–income countries as hapless guinea pigs indirectly led to the cessation of trials for Tenofovir in Cameroon and Nigeria in 2005. Although trials have recently recommenced in Ghana, Malawi, Botswana and Peru, the activists managed to slow down research considerably, delaying the market entrance of a potential life saver.
It is tempting to view this as an isolated case. But as more and more clinical trials take place in less developed countries, the groundswell of criticism is increasing. No lesser a magazine than The Scientist is leading the populist charge, with an April editorial that condemned the recent upsurge of clinical trial outsourcing to India: "If Gandhi were alive today," the magazine opined with some hyperbole, "he would lead protesters to the doors of a clinical research trials facility, where the oppression of the Indian poor dwarfs that of the 1930s."
We should not be swayed by this kind of rhetoric. Although there might be isolated cases of exploitation of trial participants, the arrival of clinical trials in the subcontinent stands to benefit both Indian and Western patients alike.
Clinical trials outsourcing is now a major business in India, with consultancy company McKinsey predicting it to be worth between $1.5 and $2bn by 2010. Over 100 companies are currently involved in outsourcing in the country, ranging from Fortune 100 heavyweights such as Pfizer and Merck, to Indian companies that have built their name mainly on generics, such as Ranbaxy and Dr. Reddy's.
India has become a favourite location for clinical trials for several reasons. Firstly, it is becoming more difficult to conduct trials in the West, as people become more risk averse and less willing to trust experimental treatments. As a result, it is becoming more tricky to gather together enough suitable subjects to make a meaningful trial—this is one of the most common reasons behind trial delays in the US.
Second, there is the cost factor. Trials can be conducted in India at fraction of the price of the US. Trials for standard drugs in the US cost upwards of $150m, a figure that can be reduced by around 60 per cent by shipping them to the sub–Continent.
But the attraction of India goes beyond simple cost considerations. Because India is more of a federation of distinct ethnic groups than a homogenous nation, it is full of genetically distinct groups—an extremely attractive factor for trial managers. And as access to medicines has for many years been so low, the majority of India's huge patient population is "treatment naïve", meaning that they will have rarely been exposed to other drugs which may complicate the action of the drug being tested.
Unlike its emerging economic rival, China, India has the singular advantage of having English as its official language. This means that all laboratory and clinical reports, as well as source and hospital documents do not require time–consuming and error–prone translation. This speeds us the whole process of registration and approval.
So much for the Pharma companies. The clinical trial outsourcing phenomena brings great benefits for India as a whole. Most obviously, it brings it much needed foreign exchange, giving a welcome lift to tax receipts and the economy. There is also some evidence that the arrival of foreign R&D companies in India has gone some way to reversing the brain drain, as thousands of highly skilled scientists return home from places such as the US and Europe. This can only be good for India.
Humanity as a whole stands to benefit from the faster, cheaper clinical trials offered by India. Put simply, it will eventually mean a greater range of cheaper drugs to tackle an ever wider spread of diseases. Although the majority of clinical trials in India focus on infectious disease and oncology, there are currently trials taking place for areas ranging from neurology to endocrinology. As more drugs come on to the market, competition between rival therapies will bring down costs and present interesting new combinations to physicians—something that is already happening with cancer drugs.
The main concern with outsourcing trials to India is preventing instances of genuine uninformed consent, which can happen when dealing with a poorly educated population. Indian regulators, alive to the ethical implications of uninformed consent, have bolstered the regulatory framework to match international standards. As most of the drugs being trialled in India are for eventual FDA and EU submission, it is also in the interest of these foreign agencies to monitor their quality.
Reputation is also important. India is a pluralistic democracy with an inquisitive media and strong civil society. It is therefore not worth the reputational risk for companies to engage in exploitative practices.
It would be wrong, then, to condemn the outsourcing of clinical trials as a new form of imperialism. The Indian government, Indian physicians and indeed, Indian patients are broadly welcoming of the practice because they are able to see its economic and medical benefits. The Indian government is doing the right thing by ignoring populist calls for limits on clinical trials. Let's hope that a vocal minority is not able to derail this most positive of developments.
Philip Stevens is director of the health programme at International Policy Network in London. He is the author of numerous health policy publications, including Free Trade for Better Health (2006) & The real determinants of health (2005), and his writings on health policy have appeared in a wide range of international newspapers. He holds degrees from the London School of Economics and Durham University.