Bad science and fire-darkened kitchen utensils
Wednesday, December 2, 2009
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.