When you go to the grocery store, how can you trust you are getting what you pay for? How confident are you that that the box of Oreos you buy will in fact contain those delicious cream-filled cookies? When you go to the drug store, do you question if the bottle of Tylenol you are buying might actually be a bottle of sugar pills? Most of us in the US would answer no: most consumers are confident that regulatory bodies such as the FDA will ensure the quality of Tylenol sold in pharmacies, and – perhaps more importantly – the quality of Oreos sold in stores. If however, you lived in a developing country, you might not be so confident.
The problem of false advertising and counterfeit drugs in the developing world is a shamefully well-known issue. Pharmaceutical companies lack the close surveillance and regulatory boards necessary to ensure quality products. As a result, drugs with very little (or adulterated) active ingredients will be mass-produced and sold cheaply. This has devastating repercussions in the health care world: serious diseases are left partially or inadequately treated. The unknowing consumer is the victim – and often a fatality – of these capital-driven enterprises. One such disease with a flourishing counterfeit drug industry is malaria.
While it is true that we have made great strides in reducing the global burden of this terrible disease, malaria continues to cause a considerable amount of death and disability – much of which is preventable or avoidable. It is estimated that over one-third of all antimalarials on the market in Southeast Asia and Sub-Saharan Africa are fake, or substandard. To make a bad problem worse, these deceptive industries pray upon the world’s poorest, most vulnerable populations. A family may travel long distances and spend hard-earned wages on treatments that are essentially ineffective. An additional problem is the emerging artemisinin resistance that results from these false or partially effective treatments. Soon, even our genuine first-line treatments may no longer be effective.
In response to this serious problem, a scientist working with the FDA named Nicola Ranieri proposed a solution: CD-3. Though it may sound like a robot name or something you remember from immunology class, CD-3 (Counterfeit Detection Device, Version 3) is our best shot at cracking down on the trouble-makers, in a quick and easy way:
While CD-3 makes its way around the globe, cleaning up the streets of pharma industries in the world’s poorest neighborhoods, perhaps we can ponder why these poor neighborhoods are the hardest hit by malaria. Is there a link between poverty and malaria? Sonia Shah in her book The Fever which investigates the different facets of malaria, says that it does.
Malaria is rampant in poor and developing nations such as sub Saharan Africa and Asia. There are a combination of factors that increase malaria risk: inadequate housing that cannot protect against mosquitos, more time spent outside and exposed to mosquitoes, and poor sanitation that creates breeding grounds. All these factors are prevalent in the poor areas and slums of these countries. This means that the poorer someone is, the higher the likelihood they are going to contract malaria.
Not only does poverty increase the risk of malaria, but malaria also causes greater poverty. Sonia Shah explains this in her TED talk.
“What we also know now is that malaria itself causes poverty. For one thing, it strikes hardest during harvest season, so exactly when farmers need to be out in the fields collecting their crops, they're home sick with a fever. But it also predisposes people to death from all other causes. So this has happened historically. We've been able to take malaria out of a society. Everything else stays the same, so we still have bad food, bad water, bad sanitation, all the things that make people sick. But just if you take malaria out, deaths from everything else go down. And the economist Jeff Sachs has actually quantified what this means for a society. What it means is, if you have malaria in your society, your economic growth is depressed by 1.3 percent every year, year after year after year, just this one disease alone.”
Comment on behalf of Rosa Castro:
ReplyDeleteThanks so much for highlighting this important problem. Not only counterfeiting or fake drugs undermine efforts to fight against malaria (and other diseases) but they have also undermined trust in generic versions of pharmaceuticals, which have an important role in facilitating access to medicines in the developing world. However, terms such as counterfeit drugs, substandard drugs and generics are sometimes used interchangeably, specially in patent-related cases. Instead, they should be carefully differentiated.
The WHO defines a generic drug as “a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights”. A counterfeit is defined as a “medicine that is deliberately and fraudulently mislabelled with respect to identity and/or source”.
It should be clear then, that a generic drug can be legally manufactured after the expiration of a patent and/or trademarks. Although it is likely that the patent holder would litigate with the generic manufacturer, generic versions could be said to work within the borders of intellectual property rights and pharmaceutical regulation. A generic version of a drug also has to pass a regulatory examination (usually by proving its equivalence with the originator’s version).
A counterfeit drug usually involves an inappropriate manufacturing process: it could lack active ingredients, have the wrong ingredients or their wrong quantities and/or a fake packaging. Its production not only contradicts the aims of intellectual property laws but also the aims of the regulatory approval system (to ascertain safety and efficacy of medicines).
As you have clearly pointed out, the commercialization of counterfeits contributes to aggravate the malaria-poverty link by raising important safety and efficacy concerns, and also increasing drug-resistance to malaria drugs. On the other hand, generic versions of pharmaceuticals, where they exist, have offered a valid alternative to enhance access (in terms of affordability) of available medicines. A net separation between both issues is necessary in order to tackle the problem of counterfeits without risking to undermine the use of generic drugs. Recent attempts to conflate both issues have threaten efforts to enhance access to medicines. Fortunately, in the case of the Kenian Anti-counterfeiting Bill, the Supreme Court eventually recognized this important difference.
Rosa Castro
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ReplyDeleteMalaria is one of the high burdens of disease in my country. Drug-resistant malaria rises exponentially mainly due to counterfeit medicines and incorrect usage. It is now threatening our neighboring country like India.
ReplyDeleteMany people are not even aware of the causes and symptoms of malaria, not to mention fake malaria drugs. In 2013, we conducted health needs assessment in Eastern Myanmar and we found that almost half of the respondents (40%) don’t know that malaria caused by mosquito bikes. We also found misconceptions about the cause of malaria with 15 percent of respondents saying drinking unclean or “bad” water and 5 percent reporting that drinking water with mosquito larvae in it can cause malaria. One-third of the respondents did not know any symptoms of malaria.
I am convinced that malaria is highly correlated with poverty. In my country, when people have flu-like symptoms such as fever, chills, and headache, many of them choose to go local village vendors. Majority of village vendors are not certified pharmacists who are capable of prescribing proper usage of medicines. They also can’t differentiate real drugs from counterfeits. That is why; drug resistant malaria has become a threat in my country and my neighboring countries.