Cambodian Inspectors examine suspected medicine in a crowded market along Thai-Cambodian border during an inspection July 23, 2010 in Pailin province, Cambodia. Photo: Getty Images
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Unregulated fake medicines are threatening the fight against diseases like malaria

There is currently no international law or body that can organise the detection and prevention of fake medicines - and it's a critical threat to our ability to fight deadly diseases.

In the UK, when horsemeat – which is not life threatening – turned up in a supermarket burgers that claimed to be made of beef, it was a national scandal. Imagine that a similar situation emerged, but this time instead of beef products, it was life-saving medicine that contained unlabeled, unsafe ingredients. You’d rightly expect the full weight of the law to come down on the manufacturers. And in the UK, that would likely be the case. You might be surprised, then, to find out that there is in fact no international law to prevent the trade in falsified medicines, and in many parts of the world without similar regulatory systems in place, these ‘medicines’ – packets labeled as a drug, but in fact containing none of the active ingredients - are big business.

In June 2012 a shipment of loudspeakers arrived in a container in the Luanda docks having travelled by sea from Guangzhou to Angola. Nothing unusual in that, given the burgeoning trade between China and Africa. However, all was not what it seemed.

Within the loudspeakers were 1.4 million packets of falsified medicine, mostly labeled as a key life-saving antimalarial drug: artemether-lumefantrine. Detailed analysis by scientists confirmed that the packets contained no active drug and would have had no beneficial affect for malaria – no more than listening to music through the loudspeakers.

There were also packets that claimed to contain the deworming medicine mebendazole. Not only did they not contain any of the active ingredient stated on the label, they did contain a drug called levamisole, a deworming medicine that has been withdrawn from human use in many countries due to severe side effects, including bone marrow failure. There has recently been an epidemic of severe blood vessel inflammation resulting from ‘cutting’ cocaine with levamisole, suggesting links between criminals producing cocaine and these falsified medicines.

Had the falsified malaria tablets got into the supply chain they would inevitability have increased death and sickness. Worse still, they could increase malaria parasites’ resistance to the real drugs which save millions of lives in sub Saharan Africa each year.

On their own, falsified medicines, containing no antimalarial, will not risk antimalarial resistance, as there is no drug in the patients’ blood for any resistant parasites to survive attack from and multiply. However, in the many countries with inadequate regulation of medicine both falsified medicines and substandard medicines commonly occur together. Substandard medicines result from errors in production and not fraud, and usually contain less than the stated amount of antimalarial compound. If patients develop very high concentrations of parasites in their blood through taking falsified antimalarials that have no effect, and then take substandard medicines, susceptible parasites in the blood are killed but the resistant ones multiply – and are sucked up by mosquitos to spread to the next unwitting patient.

This risks catastrophe for the spread of resistance to these front line drugs. If resistant parasites spread to Africa, as has already happened across Southeast Asia, the death toll will be enormous: potentially millions of lives and billions of dollars.

Over the last few decades there has been much high level debate about malaria, given the toll on lives, livelihoods and societies. The scandal is that there has been remarkably little action to ensure the quality of antimalarials. It is not regarded as a sexy subject in international public health and seems to be viewed as intractable. It is not intractable. The seizure in Angola illustrates some of the major problems in improving the global medicine supply but, as I and others have outlined in Lancet Global Health this week, there are solutions.

At the most basic level, we need a global system for mandatory reporting, assessment, and appropriate dissemination of information on suspicious medicines. The seizure in Angola was first brought to public attention on Facebook after five months and then in the Wall Street Journal after eleven months.

Although such reporting is commendable, it is grossly inadequate for public health. What proportion of African malaria patients and their families read Facebook and the Wall Street Journal? Until recently no nation had legislation requiring the pharmaceutical industry to inform the national medicine regulatory authority of drug falsification. It is extraordinary that, in 2014, such systems are widely in place for fake aircraft parts but not for medicines.

Medicine falsification, unlike money counterfeiting, is not currently regarded as an international crime, making extradition and prosecution of criminals, such as those trading in falsified medicines between China and Angola, extremely difficult. We need an international public health convention that enshrines the crime in international law, allowing extradition, and helping countries to combat criminal networks. It could also provide a financing mechanism for supporting the many countries with insufficient capacity for the regulation of medicines. Indeed, the WHO has estimated that 30 per cent of countries have no drug regulation or a capacity that hardly functions. Functional national medicine regulatory authorities are essential for the interventions needed, and to ensure that the benefits of increased accessibility to internationally financed medicines and inexpensive generics are translated effectively into improved public health.

The enormous investment in increasing global accessibility of essential medicines without investing in checking and ensuring their quality is profoundly illogical. We cannot expect the world’s medicine supply to improve without coordinated functional national regulatory systems.

We need much more vigorous and urgent action to promote Access to Good Quality Medicines or the promise of beating malaria and other endemic diseases will be squandered.

Professor Paul Newton is the director of the Lao-Oxford University-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Vientiane, Lao PDR

Photo: Getty
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PMQs review: Jeremy Corbyn prompts Tory outrage as he blames Grenfell Tower fire on austerity

To Conservative cries of "shame on you!", the Labour leader warned that "we all pay a price in public safety" for spending cuts.

A fortnight after the Grenfell Tower fire erupted, the tragedy continues to cast a shadow over British politics. Rather than probing Theresa May on the DUP deal, Jeremy Corbyn asked a series of forensic questions on the incident, in which at least 79 people are confirmed to have died.

In the first PMQs of the new parliament, May revealed that the number of buildings that had failed fire safety tests had risen to 120 (a 100 per cent failure rate) and that the cladding used on Grenfell Tower was "non-compliant" with building regulations (Corbyn had asked whether it was "legal").

After several factual questions, the Labour leader rose to his political argument. To cries of "shame on you!" from Tory MPs, he warned that local authority cuts of 40 per cent meant "we all pay a price in public safety". Corbyn added: “What the tragedy of Grenfell Tower has exposed is the disastrous effects of austerity. The disregard for working-class communities, the terrible consequences of deregulation and cutting corners." Corbyn noted that 11,000 firefighters had been cut and that the public sector pay cap (which Labour has tabled a Queen's Speech amendment against) was hindering recruitment. "This disaster must be a wake-up call," he concluded.

But May, who fared better than many expected, had a ready retort. "The cladding of tower blocks did not start under this government, it did not start under the previous coalition governments, the cladding of tower blocks began under the Blair government," she said. “In 2005 it was a Labour government that introduced the regulatory reform fire safety order which changed the requirements to inspect a building on fire safety from the local fire authority to a 'responsible person'." In this regard, however, Corbyn's lack of frontbench experience is a virtue – no action by the last Labour government can be pinned on him. 

Whether or not the Conservatives accept the link between Grenfell and austerity, their reluctance to defend continued cuts shows an awareness of how politically vulnerable they have become (No10 has announced that the public sector pay cap is under review).

Though Tory MP Philip Davies accused May of having an "aversion" to policies "that might be popular with the public" (he demanded the abolition of the 0.7 per cent foreign aid target), there was little dissent from the backbenches – reflecting the new consensus that the Prime Minister is safe (in the absence of an attractive alternative).

And May, whose jokes sometimes fall painfully flat, was able to accuse Corbyn of saying "one thing to the many and another thing to the few" in reference to his alleged Trident comments to Glastonbury festival founder Michael Eavis. But the Labour leader, no longer looking fearfully over his shoulder, displayed his increased authority today. Though the Conservatives may jeer him, the lingering fear in Tory minds is that they and the country are on divergent paths. 

George Eaton is political editor of the New Statesman.

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