Pandaemonium

THE GLOBALIZATION OF CLINICAL TRIALS

AA010633

This essay, on how profits come before people in the globalization of clinical research, was my Observer column this week. It was published on 26 April 2020, under the headline ‘We’re desperate for a coronavirus cure, but at what cost to the human guinea pigs?’


Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

The two events reveal twin aspects of the global process of drug trials and development. On the one hand, there is the ingenuity and drive that allow a potential vaccine to emerge in a fraction of the time it would normally take, as well as the courage and selflessness shown by the volunteers risking their health to test it. On the other, the increasing use of poorer nations as testing grounds for new medicines, in trials in which the subjects often have, because of poverty and lack of access to health provision, little choice about whether to take part.

The details of the proposed Chinese trial are still unclear, but it is part of what many call the ‘globalisation of clinical trials’. Until the end of the last century, virtually all clinical trials by Western pharmaceutical companies were conducted in Europe or America. The majority still are. Over the past 20 years, however, US, European and, increasingly, Chinese companies have taken to offshoring trials to low- and middle-income countries. In 2017, 90% of new drugs approved by the US Food and Drugs Agency were tested at least in part outside the US and Canada. At a time when so much attention -and hope – is focused on the possibilities of a Covid-19 vaccine, it’s worth reminding ourselves of what the development of medicines means for most of the world.

The reasons for conducting tests offshore are not hard to discern. In lower income countries, regulation is looser, staff cheaper and subjects easier to find, cutting costs by 30-40%.

Take India. It has a huge population, enormous levels of poverty, almost 20% of the global disease burden and a pitiable health infrastructure. It also has highly trained scientists and medics, skilled technicians and good laboratories. As a result, in the first decade of this century, India became the poor country of choice for many pharmaceutical companies. The proportion of global clinical trials conducted in India rose from less than 1% in 2008 to 5% six years later – just about on par with the UK.

The globalisation of clinical research has many potential benefits. It could help tackle diseases long ignored, develop medical and scientific innovation in non-western countries, improve their health infrastructure and increase the diversity of trial subjects and thereby the quality of the final product. In reality, too little of this has happened because offshore clinical trials have at their heart not a concern for the welfare of subjects or the health of local populations but the need to cut costs and generate profits.

Ethical guidelines for clinical research normally require participating patients to have access to the best available treatments for their condition. But in poor countries, the fact that people are poor has often been an excuse for researchers brushing aside such considerations.

A particularly egregious case was in the treatment of HIV in the 1990s. The standard care at that time to prevent mother-to-child transmission of HIV was a course of the drug AZT. The drug was expensive, so researchers wanted to see if other treatments might work.

In the west, the control group in such trials would have received the normal course of AZT. In a series of trials in Africa and Asia, however, the control group received not AZT but a placebo, on the grounds that poor people would normally not have received treatment anyway. Hundreds of babies were born infected with Aids when they might have been free of the virus. As Sonia Shah wrote in her book The Body Hunters, ‘Rather than working to overcome the inevitable barriers of poverty and inequity, many Aids researchers felt compelled to accommodate them.’ Too often, that remains the case.

In India, many poor people were recruited to trials without knowing that they were taking part in experiments. Thousands diedthough as no proper records were kept the true figure is unknown. Government data indicate 2,868 deaths between 2005 and 2012 and a further 2,209 between 2013 and 2015; others suggest the total might be much higher. The scandals, court rulings and parliamentary scrutiny led to a tightening of regulations. This in turn led to pharmaceutical companies pulling out of India, forcing the government to loosen regulations once more.

Equally troubling is that clinical trials in poor countries rarely address local health problems. Every year, infectious diseases take a devastating toll in India: 440,000 people die annually from TB. To put that in perspective, some 190,000 people have so far died globally so far from Covid-19. Yet just 0.7% of clinical trials in India target TB. Among children, the biggest killers are diarrhoeal diseases; fewer than 1% of trials concern gastrointestinal infections.

More than 12% of Indian clinical trials are, on the other hand, designed to find cures for cancer. That’s half as many again as the total number of trials targeting all infectious diseases. Indeed, there are more trials in India investigating skin problems, including for the development of cosmetics, than for infectious diseases. Cancers and skin problems are important to tackle, but these are conditions that more afflict rich nations – and the rich in India.

The issues that primarily affect the poor still remain largely ignored. Globally, diseases of relevance to high-income countries are investigated in clinical trials seven to eight times more often than diseases whose burden lies mainly in low- and middle-income countries.

There is little profit in tackling TB or diarrhoea. There are large bounties in cures for cancers or improvements in cosmetics. And so the bodies of the wretchedly poor become exploited to alleviate the ailments of the comfortably rich.

This year or next, we will, it’s hoped, find a vaccine for Covid-19. Once the pandemic is brought to an end, there will still be millions in the global south dying for want of basic medicines and research. Will we take their lives as seriously as we are taking the lives of those devastated by coronavirus? Will we rethink the way that clinical research is conducted and what its priorities should be? Or will we continue to ignore the poor and persist in allowing profit to take precedence over people?

One comment

  1. yandoodan

    Here’s an alternate explanation for the low number of trials for gastrointestinal diseases, or for TB: treatments for these exist, and work, but the poorest of India simply can’t afford these treatments. If this is the case, more clinical trials of drugs targeting those diseases won’t have any effect at all. What will work is reducing poverty, increasing “wealth” to the point where people can actually afford basic life-saving services.

    In the prosperous West we’ve nearly (or completely) wiped out TB, measles, cholera, malaria … there’s no good reason why these diseases remain common elsewhere. We know how to exterminate them, we just won’t pay for it.

Comments are closed.