IPN Health Blog

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.

Ukraine government provoking rise in fake medicines?

The Ukraine government has hyped up the threat of swine flu, causing panic-driven demand for medicines, claims an intriguing blog post on UkraineWatch.

According to the piece, the government subsequently:

• Caused stock-outs through scaremongering, as demand skyrocketed
• Imposed price controls
• Threatened to arrest anyone "profiteering" from the swine flu panic

As a result of the latter two policies, supply of medicines plummeted. So having boosted demand, they then quashed supply.

Smart, eh?

The article says this caused people to turn to traditional remedies (boosting their prices, too), yet an equally likely side-effect would be an increase in fake medicines.

And this month we've already had news of high levels of fakes in Ukraine - such as in this excellent report on SecuringPharma.

Reliable figures, they state, are not readily available to reveal how many fakes operate in the Ukraine market. But with neighbouring Russia's leading industry in fake Tamiflu, I bet there's a steady supply plaguing the market.

If this is the case, hopefully people will remember the policymakers who kicked it off in the first place.

Salt and Shake Spin

“UK experts” warn that the government target for cutting the salt you put on a baked potato isn’t strict enough.

That’s according to the BBC, whose coverage gives the impression the only dispute among our benign dietary overlords is between whether they should terrify us into near total salt avoidance, or just plain scare us into a slightly less tasty diet.

But there’s plenty of evidence that the whole statist plan to regulate the nation’s scrambled eggs needs to be taken with, well, a pinch of salt. When new anti-salt ads were unveiled in October, The Times quoted Catherine Collins, chief dietician at St George’s Hospital in London: “Advice to cut back on salt really is the poorest of all the dietary messages around.”

So who are the “experts” recommending that the government’s action against pork scratchings must go futher? As so often in these cases, fakecharities.org can help. Here we find that "Consensus Action on Salt and Health" receives substantial donations from the Food Standards Agency, the government agency it is supposedly lobbying for more regulation. Somehow the BBC fails to mention this.

Perhaps we need  a new study into whether state-funded charities and state-funded news websites might just have a bias towards deeper state involvement in our choice of crisps.

Marc Sidwell

Innovation versus Rationing

The latest headline-filling case of NHS rationing emerges today, with news that another new cancer drug will be unavailable to patients in the United Kingdom.

This time it's Nexavar, which can extend life for up to 6 months for people with liver cancer.

The announcement comes just weeks after the last of a long string of studies to show up the UK's quite abysmal cancer survival rates.  The UK's largely government-owned, -funded and -run health service constantly falls behind other systems which utilise private providers and offer a greater variety of choice.

Meanwhile, on a more optimistic note, the Cato Institute have released an interesting paper on Why America Leads the World in Medical Innovation.  Definitely worth a peruse.

Unless, of course, your cancer is being 'treated' by the UK's state monopoly, in which case such innovative drugs will be considered "not cost effective" enough to keep you breathing.

Seizures confusion drags on

If there's one thing we don't need in the fight against fake drugs, it's more confusion and misinformation. Yet the issue of the day--the EU's seizures of Indian medicines in transit--is being warped by mix-ups over the most basic of facts.

An article in the Business Standard today claims rather sensationally that:

"All the consignments detained so far have eventually been found to be of genuine, off-patent generic drugs on their way to countries where these are not patented."

And therefore, they argue, "there is no evidence" that seizures are defending patients against counterfeit drugs or even genuine intellectual property rights violations.

All the consignments, they say? All medicine consignments seized by EU authorities?

This seems in direct contradiction to EU Taxation and Customs documents, the last of which (published in July 2009) reported that there were 3,207 seizures in 2008, 93 per cent of which were on suspected trademark breaches.  Only a minority (6 per cent) were for patent infringement.

EU seizures of medicines increased by 57 per cent on the previous year (2007) following the launch of the MEDI-FAKE action.

This drive saw over 34 million illegal pills seized. The EU details cases of mass seizures of counterfeit medicines, such as 600,000 counterfeit antimalarials that were seized in Brussels (presumably on their way to Africa).

We know that fake medicines are entering and passing through European countries. Even in the UK authorities have reported increased amounts of counterfeit medicines being imported in recent months.

If this crucial context is ignored, and the facts obfuscated, there will never be a solution delivering free trade rights and access to high quality medicines.

Fake Russian tamiflu comes as little surprise

As fears over swine flu peaked in the summer, search engine queries for "Tamiflu" soared by 1,400 per cent according to a report from software security firm Sophos.  The correlation is not hugely surprising, nor is the news that fake Tamiflu, thriving on this sudden internet-based interest, is being produced and transported from Russia.

In June 2008 the Russian Federation Council held a meeting entitled "The role of the state in the protection of the Russian market from counterfeit medicine."  A more honest meeting would have evaluated the role of the state in flooding the market with counterfeits in the first place.

Corruption and a complete disregard for the rule of law have been at the root of Russia's counterfeiting and 'grey market' pharmaceutical trades (for more info, see Making a Killing, page 21).

A company named Bryntsalov A produce up to 10 per cent of pharmaceuticals in Russia, yet this year they were found guilty of counterfeiting over 50 brands of medicine.  Remarkably, as reported on the excellent SecurePharmaChain blog, the punishment was little more than a "slap on the wrist", with token fines dished out of no more than $1,500.  By pure coincidence, two leading figures in the company are siblings Vladimir Bryntsalov and Tatyana Bryntsalova, the former being an ex-candidate for President (yes, of Russia). Both are said to have extremely strong political links.

It is therefore little wonder that only one victim company, Pfizer, had begun taking legal action according to the article (at IPN we've stressed the importance of civil law in deterring counterfeiters - in many countries, the rule of law is so weak, and political corruption so great that civil proceedings are simply not viable). In 2006 Pfizer surveyed the fakes market in Russia, finding an unusually high standard of counterfeit drug production (which is not, of course, to say that the drugs are good). All indicators point towards a very professional class of counterfeiters, in league with the political elite.

For these reasons, one must be extremely cynical when leading political figures (including Medvedev and Putin) pledge to "protect" their people from counterfeit drugs.  Rather than looking for political saviours we should be looking for political culprits, and ensuring they're accountable for their crimes.

Trading Away Access to Medicines?

Coinciding with another controversial seizure of medicines in the EU (Paris, this time) a group of NGOs have released a joint statement criticising EU trade policy.  Oxfam, HAI, and MSF have attacked the European Commission for its support of intellectual property (IP), which they claim “benefits…IP holders at the expense of Access to Medicines for millions of people, particularly in poor countries.”

The document is essentially an anti-IP polemic, in which the signatories rail against the alleged “deficiencies” of the patent system of “leaving a research gap” and neglecting diseases. We have argued against these claims in the past but they’re tangential to the enormous health threat that everyone else (Time magazine, Jacques Chirac, the WHO, UN head Ban Ki-moon, the Gates Foundation…) is talking about—the danger of drug resistant diseases, induced by counterfeit drugs.  Rather than conflating many issues and ideologically opposing all IP, health activists should take a more practical view on how IP laws can be shaped to help poor people in less developed countries (LDCs).

Access to medicines is an insufficient goal in global health. We should be aiming for access to high quality medicines. Substandard drugs (especially counterfeits) cause more harm than good, injuring patients and burdening poor countries and healthcare resources with new waves of drug-resistant disease.

When counterfeiters fake a product, they often fake a trademark too—it’s part of their deception, to leech off the good reputation of others. Stopping these fakes is one of the simplest means of protecting the poor from bad medicines and should be acceptable to opponents of other forms of IP. Even MEP Christian Engström of the Pirate Party agrees, stating last week: “The primary function of trademarks is to act as consumer protection ... The Pirate Party has no objections in principle to combating counterfeit goods or upholding the existing trademark laws.”

EU seizures of pharmaceutical goods in 2008 were almost entirely (93 per cent) for trademark infringement—ie. on suspicion of being fakes. Only 6 per cent were for patent infringement. By focusing on a minority of cases (for patent-infringement), groups like Oxfam, HAI and MSF are ignoring the main threat to patients in LDCs; and by conflating the issues and seemingly opposing all IP, they risk damaging measures that safeguard the poor from fake drugs.

Perhaps I’ve missed statements from these groups regarding the seizures of fake drugs (rather than generics), but given the severity of the situation they should be making more noise and making clear their views. Do they really think medicines with fake trademarks should be released into poor country markets? One hopes not. It’s time we stopped obfuscating this issue with squabbles over other areas of IP and found consensus in the fight against fakes.

UN confirms bed-nets not slept under, used for fishing

The UN continues to boast of millions of dollars of public money being spent on bed-nets, this time on a project in Tanzania costing $111 million.

However, the inefficiency of such schemes is infamous. Some factors are now confirmed by Ray Chambers, the UN's special envoy for malaria, who admits that people often use the nets "to catch fish".

He also confirms that "one out of two people will not sleep under a net". This blog has previously noted how people find nets uncomfortable, or simply not much use when their living conditions are particularly poor. Furthermore, they often need to be retreated with insecticides every few months.

It is no myth that they are often sold on to make fishing nets or wedding dresses.

Amusingly this story comes just days after the news that a team of peacekeepers avoided malaria entirely by - shock horror - killing as many mosquitoes as possible. The team used housefly killing machines to protect them from mosquitoes, and remarkably the infection rate plummeted all the way down to zero.

Presumably it's too late to reinvest that $111,000,000.