Q: There are a lot of drugs being counterfeited these days, Epogen, Neupogen and Viagra to name but a few. Michael, you work in the Division of Parasitic Diseases and specialise in malaria but to turn to you first Facundo, what led you to specifically target the issue of counterfeit antimalarials?

F: In my view, what makes antimalarials an interesting market for counterfeiters is the millions of people who require this medicine, the low degree of enforcement of drug quality measures in developing countries, where malaria is more prevalent, and the ease with which these "drugs" can be smuggled across porous borders, which is an issue also related to poor infrastructure.

Q: …and what was your motivation Paul?

P: We became concerned about the problem of counterfeit Artesunate through our group’s (led by Professor Nick White) work on malaria and on these remarkable and vital new medicines. As these medicines are life-saving and widely used we were very concerned at the public health impact of fakes in malarious Asia and Africa. These medicines are also predominantly used in those countries lacking fully functional medicine regulation and oversight, and by rural farmers without access to the means for checking the quality of the medicines they need to survive. Poor quality antimalarials constitute a drastic public health problem as malaria is such a common disease that many people die from. Inevitably, counterfeit and substandard drugs will increase the number of deaths and sickness that people suffer.

Q: In your Operation Jupiter investigation you open by referring to an array of dire consequences of counterfeit Artesunate, such as death from untreated malaria, reduced consumer confidence and concerns regarding Artemisinin resistance. Does it get worse than this and what is the outlook 20 to 40 years from now should the situation be allowed to continue?

M: To be frank, the future looks bleak. The availability of inexpensive copy machines has made the reproduction of drug packaging more affordable and simple (note the increased problems with the proliferation of counterfeit bank notes). Tablets, capsules, and syrups are easily produced from commonly found materials, such as flour, chalk, lacquer, glue, dyes. In comparison to other fakes such as designer clothes or golf clubs, producing counterfeit drugs is just too easy.

F: I believe that the main fear is the stimulation of drug resistance to Artemisinin derivatives due to low quality drugs, which would render these antimalarials ineffective, forcing governments and the pharmaceutical industry to invest in the research and development of new drug candidates.

P: If there is no major change in how governments, health workers and patients regard poor drug quality the problem can only get worse. It is especially tragic as we have the means for curing malaria but counterfeits are reducing the effectiveness of these new medicines. There is little point in developing new medicines and determining the optimum dosing if the medicines that people actually take after the research has been done and national policy decided are of such poor quality that they are not curative.

Q: And do you have greater fears for Asia or Africa, Paul?

P: Most of the global malaria burden is in Africa and the Artemisinin derivative group of medicines (which includes Artesunate) hold great hope for reducing the burden there. However, if fakes continue to spread through Africa, as they have done in Asia, more people will die and the public health promise of new antimalarials will not be fulfilled. Much more emphasis is needed on inspecting, policing and regulating the supply of antimalarials in Africa.

Q: The Chinese Government has been criticised in the past for not doing enough to fight the problem of counterfeiting. Are you positive towards the Chinese Government’s actions regarding this problem?

M: I am positive and will continue to be as long as these problems are publicly exposed.

F: I am also positive, as the response was quite fast in this case, but Paul you may be more qualified to answer this….

P: My attitude is the same and, as discussed in the PLoS paper, we were greatly encouraged by the very quick and effective response, once senior Chinese officials became aware of the scale the problem and the consequences for malarial control.

Q: Your report conclusion is that “strengthening of international collaborations and forensic and drug regulatory authority capacity will be required”. What does this entail and how do you believe it can be achieved?

P: We have an enormous task ahead of us. WHO states that “Only 20% of WHO member states have well developed drug regulation and 30% have either no drug regulation or a capacity that hardly functions”. An enormous investment is required to support this 30% of countries in the form of financial and human capacity. A functioning drug regulatory authority is the keystone for the majority of interventions to improve medicine quality. If this does not function the effectiveness of medicines will inevitably be reduced and public health will be seriously impaired.

F: There is no silver bullet. Personally I feel that what we are referring to here is a combined strategy including more access to authentication tools by the end users or distributors, more education of the patients, higher penalties for counterfeiters, improving access to inexpensive medicines for populations at risk, etc. This will not be a simple process, but it starts by recognizing that drug counterfeiting is a problem that is becoming more and more common, and is as serious as illegal drug trafficking.

Q: The counterfeit culture is booming. But the psychology of a luxury goods counterfeiter must differ from that of a drug counterfeiter – Are the drug counterfeiters simply jumping on the bandwagon and out to make a fast buck, or is there a more sinister social issue that can be highlighted here?

M: Both, I’d say. The fast buck is there to be made because, as I mentioned earlier, counterfeit drugs are easy to produce with very low overheads. The sinister social issue is also there, and here I’m specifically thinking of terrorist organization involvement in producing counterfeit goods to finance their political agenda, and the production of counterfeit drugs is no exception.

P: The evidence available for counterfeit anti-infectives in the tropics suggests that this is a business – a low risk, high profit business. It’s also easy to be successful in this line of business because few have been prosecuted and must currently be a safer bet for the criminals than narcotics or people trafficking. The provision of free or inexpensive anti-infectives in the developing world should undercut the counterfeiters and – if they stop making money – presumably they will stop making counterfeits.

F: In my view, drug counterfeiting is a criminal act that intrinsically differs from counterfeiting of, let's say, an expensive purse. People's health is at stake, as counterfeit drugs are ingested or injected. From the counterfeiter's side, I would guess it’s about rapidly becoming rich, but this is done by tapping into people's basic needs, which is unacceptable. Carrying a counterfeit purse only hurts your ego if you are discovered....taking counterfeit medicine can have much more long lasting effects!