IPN Health Blog

Sealing the deal on fakes in Nigeria

Drug manufacturers should disregard profit and instil security seals on products to help patients identify fakes--this is the message from head of Nigeria's Onitsha Patent and Proprietary Medicine Dealers Union, ahead of a meeting on the topic.

His comments, while well-intentioned, are misguided on two counts.

Firstly, security tags are no guarantee against counterfeiting. Rather, they simply get counterfeited themselves.

In Kenya counterfeiters have even invented fake security tags. This story was reported just a few weeks ago.  It's for this reason that companies are turning to serialisation systems which are far more difficult to fake.

Secondly, he ignores a primary advantage in the fight against fake medicines--far from being a problem of self-interest, everyone's (apart from the counterfeiters') self interest points in the same direction. Manufacturers want to protect their profits by protecting their brands against fakers. Patients want to be confident about buying genuine products from those high quality manufacturers. Working against counterfeiters suits them both, while fake medicines harm profits and health. There are none of the "negative externalities" that critics of markets love to allege.

Even if a product is identified as fake, further problems can then be encountered. In Nigeria, according to the head of the regulator NAFDAC, cases against culprits are thwarted due to the "very, very sluggish" legal system. Some cases last over 10 years, he said recently.

Security seals, without serialisation, probably won't work. And even if they do, it's little use if legal action cannot be quickly and efficiently taken against the culprits in court.

GOTCHA!

More developments in the Argentinian fake medicines scandal which, in case you haven't been reading, has been linked to key supporters of the President.

Already arrested are the head of a trade union (and, oddly, his girlfriend) and head of a pharmaceutical company. And four others.

Now reports suggest officials in the Ministry of Health are implicated and that more arrests will follow.

Where fake drugs exist, corruption is typically not far behind. This serves as yet another example of why the problem cannot be solved by increasing the power of politicians and government officials. They're often the ones driving the fakes in the first place.

GOTCHA! Update: the under-secretary of Health, Buenos Aires, has turned himself in. Click here for the report.

Bad science and fire-darkened kitchen utensils

Indian industry website Pharmabiz today reports that "health ministry sources" are accusing IPN of "unscientifically" constructing reports on fake medicines--while promoting a new government survey that claims just 0.04% of Indian drugs are fakes.

Let us examine the accusations, whoever they come from:

The principal objection is to a single figure referred to in our paper Keeping it Real, derived from the Associated Chambers of Commerce and Industry of India and stating that the fake drug market is growing by 20–25 per cent per annum.

The claim is that this is an unreliable figure, used to falsely portray fake drugs as a problem for India, while new government data shows it's a negligible problem.

So where to start?

Well firstly, our paper correctly names the source and provides full citations for this stat. But more importantly no claim rests on the figure alone. The paper provides other examples of fake Indian drugs being discovered--such as EU Customs figures and Indian surveys.

And it could have listed much more. For example, a 2008 study in six major African cities found that 31% of drugs listed as being from India were substandard. A subsequent study of drugs bought from shop-front pharmacies in New Delhi and Chennai found 12% of drugs were substandard.

And here are some recent headlines from the Indian press:

• Indian Express, 1st December: "Fake drugs are sold rampantly"
• Times of India, 14th November: Cops identify fake drugs "kingpin"
• Times of India, 13th November: Cops smell fake drug racket
• ExpressBuzz, 10th November: Sri Lanka bans four Indian drug companies for supplying sub-standard and adulterated drugs
• Economic Times, 20th October: Criminal proceedings against Hyderabad pharma company

And so on.

Media headlines may not provide scientific proof, but the New Delhi and Chennai study, peer-reviewed in a respected journal, certainly does. And it shows that some people involved in the Indian supply chain provide very high levels of substandard drugs--indicating deliberate foul play and the spread of counterfeit medicines. In two pharmacies, for example, over 1 in 4 drugs sold was seriously substandard--some of them containing zero active ingredients.

The government statistics which Pharmabiz cites, however, are less robust. Rather than releasing the data, the headline findings were leaked in September to ... that's right, Pharmabiz.  Almost three months later the same headlines appeared in Mint.  The headlines claim, somewhat remarkably, that out of 24,000 sampled drugs, only ten were fake (or 'spurious'). It's unclear how authorities continue to find fake drugs, as reported in the media week in week out, if only 0.04% of the market is fake.

There are, however, grounds for suspicion. Strangely, the medicines procurred in the government's survey were simply handed over to manufacturers--with only those who responded saying the products were counterfeited being counted as 'spurious'. The samples were then collected back, and tested for quality.

As unusual as this methodology is, a notable omission from the Pharmabiz article is what proportion of the drugs were then found to be substandard.  Previous Indian state surveys, while finding very low levels of 'spurious' drugs (often without defining 'spurious') have found substandard drug levels ranging between 8.19% to 10.64% over several years. And some areas, such as Haryana state, recorded substandard levels of over 40% (!)

The peer-reviewed survey referred to above shows that the clear majority of Indian pharmaceuticals are of high quality, and many suppliers are honest and well-intentioned. But clearly a minority are getting away with pushing at best substandard, and at worst blatantly fake drugs.

If the government has useful data on this subject then the methodology and data should be made public. Burying heads in the sand by leaking sensationalist headlines to industry websites is the real "unscientific" practice here, and helps neither patients nor the industry itself.

"Envy of the world" shown up again

Britain's state-run National Health Service (NHS) doesn't fare too well in comparisons of cancer survival rates.  Every year studies show far more deaths under the NHS's watch than in countries of comparable wealth.  "20% higher than Europe" reported a recent headline, while new cancer drugs continue to be rationed, often considered "not cost effective".

Now it's the turn of survival rates within the UK to throw up some shocking results, and destroy a few fallacies in the process.  The Guardian reports that your likelihood of beating cancer differs hugely depending on where in Britain you live.  People in plush Kensington & Chelsea, lo and behold, are three times more likely to survive a year than folk out in Herefordshire.

So back to those fallacies - firstly, there is no such thing as "healthcare" as a set, unvariable service. Just like food, cars, shoes et cetera, healthcare standards are completely variable - and new innovations constantly provide standards that people could not have dreamed of in the past. Like the aforementioned products, higher standards will come with higher costs, and therefore higher prices.

Secondly, these variations cannot be ironed out by government-provided services. We simply end up with varying services and less choice between them. Typically it's the poor who lose out, just as children in deprived inner-city areas are obliged to attend worse state schools than children in leafy home counties with a comfortable local comp in the village. The "postcode lottery", often not a lottery at all, affects both these state monoliths.