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active ingredient stated on the label, they did contain a drug called levamisole, a deworming medicine that has been withdrawn from human use in many countries due to severe side effects, including bone marrow failure.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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Autumn Statement 2015: George Osborne abandons his target

How will George Osborne close the deficit after his U-Turns? Answer: he won't, of course. 

“Good governments U-Turn, and U-Turn frequently.” That’s Andrew Adonis’ maxim, and George Osborne borrowed heavily from him today, delivering two big U-Turns, on tax credits and on police funding. There will be no cuts to tax credits or to the police.

The Office for Budget Responsibility estimates that, in total, the government gave away £6.2 billion next year, more than half of which is the reverse to tax credits.

Osborne claims that he will still deliver his planned £12bn reduction in welfare. But, as I’ve written before, without cutting tax credits, it’s difficult to see how you can get £12bn out of the welfare bill. Here’s the OBR’s chart of welfare spending:

The government has already promised to protect child benefit and pension spending – in fact, it actually increased pensioner spending today. So all that’s left is tax credits. If the government is not going to cut them, where’s the £12bn come from?

A bit of clever accounting today got Osborne out of his hole. The Universal Credit, once it comes in in full, will replace tax credits anyway, allowing him to describe his U-Turn as a delay, not a full retreat. But the reality – as the Treasury has admitted privately for some time – is that the Universal Credit will never be wholly implemented. The pilot schemes – one of which, in Hammersmith, I have visited myself – are little more than Potemkin set-ups. Iain Duncan Smith’s Universal Credit will never be rolled out in full. The savings from switching from tax credits to Universal Credit will never materialise.

The £12bn is smaller, too, than it was this time last week. Instead of cutting £12bn from the welfare budget by 2017-8, the government will instead cut £12bn by the end of the parliament – a much smaller task.

That’s not to say that the cuts to departmental spending and welfare will be painless – far from it. Employment Support Allowance – what used to be called incapacity benefit and severe disablement benefit – will be cut down to the level of Jobseekers’ Allowance, while the government will erect further hurdles to claimants. Cuts to departmental spending will mean a further reduction in the numbers of public sector workers.  But it will be some way short of the reductions in welfare spending required to hit Osborne’s deficit reduction timetable.

So, where’s the money coming from? The answer is nowhere. What we'll instead get is five more years of the same: increasing household debt, austerity largely concentrated on the poorest, and yet more borrowing. As the last five years proved, the Conservatives don’t need to close the deficit to be re-elected. In fact, it may be that having the need to “finish the job” as a stick to beat Labour with actually helped the Tories in May. They have neither an economic imperative nor a political one to close the deficit. 

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