When the first patients began showing up at his door with their health in dramatic decline after taking the treatments he had prescribed, Ibrahim Ali Toure knew he was facing a major health crisis.
As the head of the cardiology department at Niamey University Hospital in Niger, Toure treats thousands of people annually. The flow of patients that come by his office continues uninterrupted, but he receives everyone without complaint. The vast majority suffer from hypertension. Commonly known as high blood pressure, the condition can increase the risk of cardiovascular complications, including strokes, heart attacks or heart failure if not treated properly.
In Niger, as in many other sub-Saharan countries, cardiovascular mortality has been on the rise in the past 25 years, and hypertension is a major culprit. Part of the problem is that many people are not diagnosed in time, as the symptoms are rarely noticeable, but successful treatment is also a challenge. ‘Only about a third of people with hypertension get a proper and timely diagnosis,’ says Toure, ‘but more than half of those then struggle to access the treatments they need.’
This situation has recently taken an unprecedented turn. Even when they manage to get treated, a growing number of patients come back with deteriorated health.
‘I’ve had patients hospitalized after sustaining strokes, others who suffer from heart failure after taking medicines. As a doctor, it’s disheartening to see this after diagnosing high blood pressure successfully, and doing everything to improve it,’ Toure explains.
This scenario is far from unique to Niger. It has repeated itself across many sub-Saharan countries in the last few years, leaving doctors greatly concerned about the quality of the drugs they prescribe. One in ten drugs sold in developing countries is fake or substandard (see box) according to the World Health Organization (WHO), and cardiac drugs could be disproportionately affected.
African cardiologists have been raising the alarm for months now, but in the absence of robust scientific studies implicating the safety and quality of cardiac drugs in Africa, they have struggled to make themselves heard.
This is why Toure and colleagues in nine other African countries decided to join forces with Marie Antignac, a researcher with the French National Institute of Health and Medical Research (Inserm). They collected thousands of samples of seven routinely prescribed cardiovascular drugs from street markets and pharmacies, and sent them to the Paris lab for analysis. Published in the International Journal of Cardiology, their study is the first ever to assess the threat of fake cardiovascular medications in Africa.
What are fake medicines?
Substandard drugs are poor quality drugs. They are authorized medical products that do not meet their quality standards and/or specifications.
Falsified medical products (counterfeit drugs) deliberately misrepresent their identity, composition or source.
The researchers established that about 16 per cent of all the collected drugs were of poor quality. Among the specimens from Niger, almost one in four drugs was deemed problematic, although there was no way of telling whether they had been deliberately falsified or just poorly produced.
Photo: Riccardo Lenneart Niels Mayer / Alamy
Although none of the samples appeared to contain toxic compounds, some had too low a dose of the active ingredient, rendering them inefficient to treat the disease. ‘Giving patients drugs that do not contain the right amount of active ingredients is almost as dangerous as treating them with toxic compounds,’ Antignac points out. ‘It explains why patients have been coming back with elevated blood pressure. When you have an asymptomatic disease like hypertension, patients think they are being treated when in fact the medication is not having an effect, and they may end up developing cardiovascular complications.’
Fighting a new plague
In the past, cardiovascular diseases were not a major source of concern in African countries. Most of the efforts were focused on reducing the burden of infectious disease, like malaria.
In just a quarter of a century, this has changed dramatically. Around 46 per cent of adults in sub-Saharan Africa are now thought to have hypertension. Estimated to be one of the greatest public health challenges on the continent after HIV/AIDS, cardiovascular diseases have now replaced tuberculosis and malaria in the top five primary causes of death.
‘Africa is currently undergoing an epidemiological transition,’ says Antignac, ‘whereby non-communicable diseases are slowly replacing infectious diseases as the main cause of death. In Europe, a similar transition occurred in the space of 300 or 400 years, but in Africa it has happened roughly over three decades. Public awareness is still low; most people still see Africa as a continent where people die from infections, not from hypertension, obesity or diabetes.’
As a result, the response of public health systems has been slow. Nowhere is this better seen than in the fight against fake medicines. While resources have been mobilized to identify and fight poor quality or falsified antimicrobial agents, research into the quality of other types of drugs sold in African countries, including cardiovascular drugs, had been relatively neglected until the publication of the recent study.
For unscrupulous companies and criminals trading in counterfeit medicines, this situation represents a major opportunity.
‘The criminals who deal with substandard and falsified medicine are in it for the money. They look at market dynamics and follow the demand,’ says Pernette Bourdillon Esteve, an expert in this field at the WHO. ‘If a demand for a given treatment rises, combined with poor governance and weak technical capacity, you can expect a rise of substandard or falsified products.’
One of the most striking findings of the recent study suggests that whether drugs are sold in pharmacies or on the street matters less in terms of quality than the country of manufacture. Poor quality appeared to be associated more with drugs produced in Asia, but not so much with those produced in Europe or Africa. The lesson might then well be that regulating the trade of medicine on the street is important, but improving quality control and surveillance of the way drugs are manufactured may be even more crucial.
‘We need to improve surveillance at all levels of the supply chain, identify which labs in Asia are legitimate,’ says Antignac. ‘Our Paris lab is also now at the disposal of doctors, to conduct quality tests of samples they send us. Such tests are not easy to do on the ground, because of the huge political and economic pressures that local investigators often face.’
But other barriers to treatment also need to be addressed in order to turn the tide. In the absence of universal health coverage, many families cannot afford any medication, no matter the quality.
‘Patients have to pay themselves for analyses, hospital stays and treatments,’ says Toure. ‘I’ve sometimes had to help them financially to prevent deaths. We have long been lacking medical staff and infrastructure. When people do get seen by a doctor, they often can’t pay for it. Poor quality drugs is just a continuation of these problems – now, those who do manage to pay, risk ending up with drugs that do not work.’