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active ingredient stated on the label, they did contain a drug called levamisole, a deworming medicine that has been withdrawn from human use in many countries due to severe side effects, including bone marrow failure.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 Images
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The buck doesn't stop with Grant Shapps - and probably shouldn't stop with Lord Feldman, either

The question of "who knew what, and when?" shouldn't stop with the Conservative peer.

If Grant Shapps’ enforced resignation as a minister was intended to draw a line under the Mark Clarke affair, it has had the reverse effect. Attention is now shifting to Lord Feldman, who was joint chair during Shapps’  tenure at the top of CCHQ.  It is not just the allegations of sexual harrassment, bullying, and extortion against Mark Clarke, but the question of who knew what, and when.

Although Shapps’ resignation letter says that “the buck” stops with him, his allies are privately furious at his de facto sacking, and they are pointing the finger at Feldman. They point out that not only was Feldman the senior partner on paper, but when the rewards for the unexpected election victory were handed out, it was Feldman who was held up as the key man, while Shapps was given what they see as a relatively lowly position in the Department for International Development.  Yet Feldman is still in post while Shapps was effectively forced out by David Cameron. Once again, says one, “the PM’s mates are protected, the rest of us shafted”.

As Simon Walters reports in this morning’s Mail on Sunday, the focus is turning onto Feldman, while Paul Goodman, the editor of the influential grassroots website ConservativeHome has piled further pressure on the peer by calling for him to go.

But even Feldman’s resignation is unlikely to be the end of the matter. Although the scope of the allegations against Clarke were unknown to many, questions about his behaviour were widespread, and fears about the conduct of elections in the party’s youth wing are also longstanding. Shortly after the 2010 election, Conservative student activists told me they’d cheered when Sadiq Khan defeated Clarke in Tooting, while a group of Conservative staffers were said to be part of the “Six per cent club” – they wanted a swing big enough for a Tory majority, but too small for Clarke to win his seat. The viciousness of Conservative Future’s internal elections is sufficiently well-known, meanwhile, to be a repeated refrain among defenders of the notoriously opaque democratic process in Labour Students, with supporters of a one member one vote system asked if they would risk elections as vicious as those in their Tory equivalent.

Just as it seems unlikely that Feldman remained ignorant of allegations against Clarke if Shapps knew, it feels untenable to argue that Clarke’s defeat could be cheered by both student Conservatives and Tory staffers and the unpleasantness of the party’s internal election sufficiently well-known by its opponents, without coming across the desk of Conservative politicians above even the chair of CCHQ’s paygrade.

Stephen Bush is editor of the Staggers, the New Statesman’s political blog.