Counterfeit drugs — silent murderers

By Rebecca Kwei
It was a sunny Monday morning as I boarded a ‘trotro’, dreading the traffic and the more than one-hour journey to the office. Soon I was dozing off till someone yelled, “Praise the Lord” which jostled me out of my slumber.
“Not these ‘van preachers’ again” I murmured. Fortunately or unfortunately, he wasn’t a ‘van preacher’ but a drug peddler preceding his illegal business by invoking the forces of the Good Lord and pretending to be a preacher. Knowing the spate of road accidents in Ghana, this man was using the “fear factor” by praying for journey mercies for all the passengers and then quickly proceeding to his real aim — selling all sorts of medicines to unsuspecting citizens!
From deep within the bag he had strapped on his shoulder, he pulled out a drug claiming it could cure all manner of diseases — from diabetes to hypertension; erectile dysfunction to malaria; impotence to depression and childlessness to poverty, if one counted poverty as a disease. Of course most passengers patronised the ‘goody’, since he was offering two for the price of one. This was not the first time I had encountered a drug peddler — in fact they are everywhere in Africa — from those who carry the medicines on their heads and roam the streets to those who sell in mini vans.
Counterfeiting has been with us since the dawn of creation and appears in almost all cases to be motivated by the desire to make quick money. In the 1st Century AD, Dioscorides, a Greek Physician, warned of the dangers of adulterated drugs, an issue which still persists today and is a serious threat. Imagine you have malaria and you are taking artesunate-amodiaquine, the recommended first line treatment in Ghana, only to find out later that the medication had no effect. You surely will not get better and in the case of children or non-immune adults, this can easily lead to death from untreated malaria. Frightening! Isn’t it?
And yet this used to occur as late as the 17th Century when it was detected that the bark of the Peruvian Cinchona that is used to treat malaria was being adulterated with cheaper substances in order to increase profits. People did not get well and some died. The staggering size of the counterfeit pharmaceuticals market estimated to be about US$75 billion in 2010 alone shows this is serious business; even if it is deadly business too.
Each year counterfeit drugs are responsible for thousands of deaths worldwide. Some of these fake drugs contain nothing, some chalk in capsules, and some of them little or none at all of the active ingredients, and yet others contain dangerous additives including paints, industrial chemicals, banned substances and impure compounds.
The counterfeit issue was first discussed by the World Health Organisation (WHO) in 1951 when the Director-General considered the advantages of more uniform methods for drug control. However, it was not till the 1985 Conference of Experts on the Rational Use of Drugs held in Nairobi Kenya that the current anti-counterfeiting initiatives gathered full steam.


Kofi’s story
Kofi (not his real name), had severe stomach pains accompanied by high temperature, sweating and diarrhoea. He visited the polyclinic and some medicines were prescribed, he purchased the drugs from the usual “drug seller”. After three days of taking the medicine, his situation got worse; the pain in the stomach became excruciating. The last thing he knew he was in hospital, where it was discovered he had been given fake ciprofloxacin, meaning the typhoid infection he was suspected to have, had not been treated leading to perforation of his intestines. He was the lucky one who got away, though he had to endure emergency surgery.

Fake Coartem in Ghana
In July 2009, the issue of fake/counterfeit medicines came up again in Ghana.
The Food and Drugs Board (FDB) warned the public of the sale of fake Coartem tablets in Kumasi in the Ashanti Region. Coartem (artemether-lumefantrine) is one of the fastest selling antimalarial medicines in Ghana and at the time, one of the most expensive as well. Its effectiveness is such that patients accept the high price associated with it. The FDB confiscated 150 packs of the product from nine wholesale and retail pharmacies (note, not drug peddlers but pharmacies) involved in the distribution and sale.
The FDB said confirmatory tests on the fake products showed that the fake Coartem tablets did not contain any artemether-lumefantrine, the main active ingredients of the original Coartem tablet.

Ripple effects of counterfeit/substandard medicines
It has been estimated that up to 15 per cent of all sold drugs are fake, and in parts of Africa this figure exceeds 50 per cent.
Dr Patrick Lukulay, the Director of the United States Pharmacopoeia Drug Quality and Information Programme, says there is need for more public education on the effects of substandard and counterfeit medicines to the public.
“People should be made to understand that medicine quality is not a luxury but a matter of life and death,” he stressed.
Dr Lukulay described fake/counterfeit medicines as “deliberately mislabelled with respect to identity, amount and source” while substandard medicines refer to legally sold products which fall short of the expected and approved quality specifications”.
The ripple effects of counterfeit/substandard medicines are numerous: it is a threat to public health and economic development and a burden on national health care. Since patients end up not treated, their conditions do not go away and they may visit hospital again – a clear drain on national resources.
“People who take counterfeit drugs may have less of the active ingredient and could die because they are not receiving their life-saving treatment,” Dr Lukulay said.
It is estimated that about $12 billion is lost in wages due to counterfeit/substandard medicines, since failed treatment leads to more days out of work.

China, India, Nigeria — hub of fake medicines?
The Guardian (UK) in a story headlined “Health fears grow as fake drugs flood into Britain” in January 2010, said counterfeiting gangs based in China were producing sophisticated copies of the world’s bestselling pharmaceuticals.
The story said in 2008, an estimated eight million of these potentially deadly pills found their way to the United Kingdom’s National Health Service (NHS).
In 2007, Zheng Xiaoyu, the former head of China’s Food and Drugs Administration who was found guilty of taking bribes to license fake drugs, was executed.
According to Internet reports, about 20 per cent of drugs sold in India are fake.
Figures released by the Organisation for Economic Cooperation and Development state that almost 75 per cent of fake drugs exported the world over accrue from India.
Dr Dorothy "Dora" Akunyili, the former head of the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria, waged a relentless war against counterfeiters.
A survey conducted by the WHO found more than half the drugs on sale in Nigeria were fake or substandard.
"Counterfeit drugs are murder," says Dora. "It is the highest form of terrorism against public health because it kills a large number of people"
Despite an attempt on her life, Dr Akunyili continued to wage this war driven by memories of a personal tragedy. Her 21-year-old diabetic sister, Vivian, died in 1988 because of a fake insulin injection.
News report credits the effort of Dr Akunyili and NAFDAC, for the reduction in the level of fake drugs in Nigeria to 35 per cent down from about 70 per cent in 2001.

Winning the war against counterfeit/substandard drugs
The WHO notes that the increasing international trade of pharmaceuticals and sales via the internet has further facilitated the entry of counterfeit products into the supply chain.
In 2006 this led to WHO's launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which has been the main conduit for WHO's work against counterfeits since.
In Ghana there are sentinel sites in Bolgatanga, Kumasi, Ho, Accra and Tarkwa for drug quality monitoring.
These sites could help in the identification of counterfeit medicines though all avenues for medicine supply and distribution are also avenues for the proliferation of counterfeit medicines.
Prof. Alex Dodoo, the President of the International Society of Pharmacovigilance and Director of the Centre for Tropical Pharmacology and Therapeutics of the University of Ghana Medical School, says counterfeiting has become increasingly sophisticated and requires a multi-sectoral approach involving academicians, policy makers and civil society.
“The fake Coartem story shows how legitimate pharmacies and chemical sellers’ shops could also be used to supply counterfeit medicines. Vigilance is, therefore, needed always and consumers should check and check again all products they purchase. If in doubt, report to the FDB or the law enforcement agencies,” Prof. Dodoo advises.
He insists that all countries should develop appropriate systems to enable them to quickly identify the supply route for all medicines, including unlicensed and fake products. This is the best way of protecting the public, who most often will not be able to tell the difference between a fake and a genuine product. Not everyone will be as lucky as Kofi.