I’m going to comment on the Guardian article We’re desperate for a coronavirus cure, but at what cost to the human guinea pigs?, which attacks capitalism for its uncaring approach to medical research.
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.
These both seem like good things to me.
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.
Are the poor subjects being forced to take part? If they are doing so voluntarily because they are receiving benefit for doing so, what is the problem?
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. But over the past 20 years, 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.
Given the over-regulation in the EU and Canada, it’s a wonder that any research is conducted here at all. The burden placed by the FDA famously led to an entire industry, document control systems, emerging because of the need of drug companies to deal with the masses of paperwork required. Is it surprising that companies go where it is easiest to do their work?
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%.
Exactly. And the lower the costs, the more new drugs will be created, which is good.
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.
And this benefited India.
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.
Of course companies who are targeting specific profitable drugs are not going to expend money on local health issues. Why would they? The benefits of having locally trained experts be able to get practical experience in developing drugs will trickle down, just as when IT jobs were off-shored to India, it eventually led to a thriving local high technology industry.
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.
This is a legitimate issue. Measuring a new treatment against the best available treatment leads to advancement, whereas testing against an untreated control population may show a drug is effective, but it may be less effective than an existing treatment.
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.
Makes sense. If there are two equally efficacious treatments and one is cheaper, it is a better treatment, because it can be given to more people.
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.
If the alternative was not doing the research because it would have been too expensive, isn’t it better that the research was done?
In India, many poor people were recruited to trials without knowing that they were taking part in experiments. Thousands died, though 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.
If fraud was occurring, government regulation was the correct response. Companies pulling their trials because they weren’t allowed to commit fraud does not “force” a government to loosen regulations. India is a democracy. The people are free to vote in a regime that won’t cow-tow to companies that demand to be allow to defraud them.
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, more than 190,000 people have 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.
For profit companies are not responsible for curing any particular disease. India is free to publicly fund as much tuberculosis research as its people demand.
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.
For profit companies are going to look to create products that will make money, so that they can recoup the cost of research and make a profit.
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.
If they are voluntarily participating and benefiting from doing so, it is not exploitation of the poor. Paying a poor person to dig a ditch because no rich person would do so for a reasonable cost is not exploitation.
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?
Who is “we”?
For-profit companies want to be the first to develop a Covid-19 vaccine because doing so will make them a lot of money. Many of these same companies also take philanthropy very seriously. For example, when Merck found an unprofitable cure for river blindness, the company paid to distribute the cure to those who needed it at their own expense. They wouldn’t be able to do this if they couldn’t make money on other products.
If by we, you mean “we the people”, hopefully, when the economy has recovered, people will be more generous in donating to public medicine. For example, I have long donated monthly to BC Children’s Hospital, which once saved the life of one of my children.
If you mean government, government does no do. Governments can take money from corporations and people and reallocate it to other corporations and people to conduct research for “the poor”, but they can’t create a lasting profit motive for doing so, and, in the aftermath of Covid-19, there will be little sympathy for governments raising taxes during the ensuing economic depression, not to mention the fact that they have taken on massive new debts during the crisis.