Outsourcing drug trials

Many UK firms, particularly utilities, telecom and the finance industry, went through a period of outsourcing their customer departments to India where there is a vast and skilled workforce who the companies’ jobs done cheaper and faster. Many found that it may have saved money but it hugely increased customer complaints and a sense of being dislocated from their money and accounts, and now it looks as if the pharmaceutical industry in the United States is heading down that same road.

This time the complaints are not about the jobs that are being outsourced, but about the dangers to the health and safety of the Indian workers. It’s all about the development of new drugs, because the cost of bringing a new one to market is, on average, $1 billion. The bulk of that cost is devoted to human clinical trials — the most crucial and time-consuming phase of drug development. Faced with tight regulations at home and shrinking profits due to expiring drug patents, western drug makers are looking to expedite the process by outsourcing safety and efficacy studies to developing countries, a large proportion of them to India. An amendment proposed last year by the technical advisory committee of India’s Health Ministry would further allow drug companies to test their products widely on patients in India before they’re proved safe at home, which is causing alarm bells to ring as drug testing can be a dangerous business for the volunteers.

The UK has had some experience of just how dangerous that can be in 2006, when six men nearly died in a safety trial when given an experimental antibody drug called TGN1412. This was its first human trial, and the drug caused multiple organ failure in all six men. Speedy action on the part of the doctors saved their lives, but the concern is that such experiments could be potentially devastating in a country that lacks the medical infrastructure to care for people harmed by untested drugs. There are currently some 400 clinical trials underway in India, where the business is expected to be worth $1 billion to $1.5 billion by 2010. For western drug companies, it’s a boon: India’s vast pool of qualified, English-speaking doctors and lower labour costs make clinical trials up to 50% to 60% cheaper and it’s not just money the drug companies are saving.

India also offers a crucial savings on time. A drug patent lasts 20 years; during the first seven or eight years of that period, typically, a new drug is tied up in several rounds of human clinical trials. That leaves little time for the drug maker to market and profit from the product. To speed up trials, pharmaceutical companies need to recruit large numbers of subjects quickly, something that is often not possible in western countries, where most patients have health insurance or government benefits and are reluctant to sign up. In India, by contrast, much of the population has no health insurance, and public health services can be widely variable. The promise of getting regular medical attention by enrolling in a trial is often too valuable to pass up so that many patients enter into clinical trials because they have no better option to receiving care.

This is not just a theoretical problem; already, toxic drugs have posed problems. In 2002, a human trial in India, along with 31 other countries, of Novo Nordisk’s diabetes drug ragaglitazar had to be suspended after a trial in mice revealed that the compound caused urinary bladder tumors. In 2003, news circulated that researchers from India-based Sun Pharmaceuticals had given the anticancer drug letrozole to 430 young women to see if it would induce ovulation, despite the fact that the drug is known to be toxic to embryos.

No one wants to deny such a rich source of income to India, but if clinical trials which will affect thousands of patients are not properly monitored and conducted then we could be facing new drugs marketed with too much haste and not enough control.

What happens in the USA is often what happens in the UK a short time later, but I hope this is one trend that does not make it across the Atlantic unless we get some very strong reassurances about the need to outsource a vital component of our healthcare system.