The Pharmaceutical Industry: a key player in development

In 1996 a meningococcal meningitis epidemic was declared in Kano’s State, Nigeria. Doctors Without Borders (Médecins sans Frontières) responded sending a team of volunteer physicians to the city of Kano, capital of the region and second largest city of Nigeria. They treated patients with chloamphenicol, one of the two antibiotics, as well as ceftriaxone, recommended by the World Health Organization (WHO) to treat meningococcal meningitis in areas that have limited health care resources of Africa.

At the time of the epidemic, the US pharmaceutical Pfizer was trying to obtain the approval of the US Food and Drug Administration for the antibiotic Trovan (Trovafloxacin). In order to gain a better knowledge of its effects in children, Pfizer sent a research team to Kano, depicted as philanthropic work.

They treated 200 children, half of them with Trovan and the other half with ceftriaxone, as comparison group. However, in an effort to save time, the ceftriaxone was not administrated following the standards of the manufacturer: the dosage was reduced to one third of the recommended and it was injected in the buttocks instead of into a vein.

After three weeks, the Pfizer’s team was unable to determinate the effectiveness of the treatment and abandoned Kano. By the end of Nigeria’s epidemic, at least 8,000 people had died, many of whom were children, and more than 75,000 had been infected (WHO, 2011).

In 2002, Pfizer was sued by a group of Nigerian Trovan affected, alleging that “they suffered grave injuries from an experimental antibiotic administered by Pfizer without their informed consent”.

Firdausi, one of the affected by Trovan with her mother. El País.

Plaintiffs alleged that those administered with Trovan that didn’t die, suffered from impairing side effects. After 4 judicial opinions from different courts, in 2009, Pfizer settled the case out of court with a $75 million settlement that was subject to a confidentiality clause.

The Kano Case had not only consequences in terms of those directly affected by the clinical research, but also related to following health initiatives. The 2005 program of the WHO to eradicate poliomyelitis clashed with the resistance of Kano’s radical Islamist authorities, opposing to the vaccination and spreading the mistrust to the surrounding areas.

The big picture

This case shows the important role that pharmaceutical companies play in development. This importance is more obvious considering the fact that 3 of the 8 Millennium Development Goals for 2015 are related to health: reduce child mortality; improve maternal health; combat HIV/AIDS, malaria and other diseases.

The global pharmaceuticals market is worth US$300 billion a year, a figure expected to rise to US$400 billion within three years (WHO). North America, Europe and Japan account for the 74% of the market.

World pharmaceutical market. IMS Health Market Prognosis, June 2013.

This means that approximately 5.7 billion people (80% of the world population) share only the 26% of the global pharmaceutical market. Although low-income countries spend higher percentage of their budgets in pharmaceutical products than high-income countries, in absolute figures, the expenditure is so small that many drug developers don’t even bother to take out patents in poor countries.

Moreover, the low people’s purchasing power in developing countries not only limits their access to drugs but also determines the development of new ones. The research and development (R&D) of new drugs is mostly controlled by the private sector, which spend billions of dollars each year in the search of new products for the mass market. Though developing countries have been benefited with the development of new drugs, the main focus of private sector’s R&D is in the drugs that are more likely to provide a high return on the company’s investment. Consequently, the development of drugs for treating diseases common in high-income countries is prioritized over those that affect low-income countries.

“Pecoul et al. (1999) report that of the 1.233 drugs licensed worldwide between 1975 and 1997, only 13 were for tropical diseases. Of these, five came from veterinary research, two were modifications of existing medicines, and two were produced for the U.S. military. Only four were developed by commercial pharmaceutical firms specifically for tropical diseases of humans.” Michel Kremer, 2002

As a consequence of the disregard to the highly spread diseases in tropical areas, the term neglected tropical diseases (NTD) was coined. The WHO acknowledges 17 NTD at the moment, ranging from leprosy to rabies. The relation between NTD and poverty is so tight that the first can be use as an indicator of extreme poverty, associated with the lack of fresh water and sanitation.

But not only is the lack of specific medication for certain diseases the cause of mortality. Most of the low-income countries have very weak or non-existing at all health systems. Qualified personnel are scarce and have a huge workload, resulting in wrong prognosis. Furthermore, subjective perception influences in the prescription of inappropriate treatment. Such is the case in Africa, where injections are often prescribed rather than pills, as many patients see these as more powerful (Kremer, 2002).

In addition, self-prescription and self-medication are more extended the poorer is the country. Patients purchase and consume medication without the supervision of a physician, and in most of the cases, the treatment is not completed in its entire course. This leads to the development of drug-resistant forms of diseases, which increase the threat also to high-income countries.

Top 10 causes of death in low and high-income countries. WHO.

Breaking the circle

Disease is not a cause of poverty, but an outcome of it that contributes to impoverish even more. It affects people undernourished, dwelling in slums and without pure water or sanitation. It impairs their capacity to work, turning them incapable to provide for themselves. This is the vicious circle of poverty-disease.

In order to break the circle, the access to medicines is the key factor. Although a simple concept, it is a very complex issue to achieve. Taking in consideration that expenditure on pharmaceutical products accounts for the major proportion of health cost in low-income countries (WHO); then, access to treatment is heavily dependent on the availability of affordable medicines. In terms of affordability, the WHO proposes different solution, such as differential pricing or equity pricing. But low pricing alone does not secure access to treatment. Efficient health care systems, well provisioned and with qualified professional, are key.

The primary role of the pharmaceutical industry is to develop pharmacological products that can be sold in markets at a profit. In most of the cases, a drug or vaccine has high fixed costs in the R&D process, while the marginal costs of production are, comparatively, very low. The willingness to pay in low-income countries borders this marginal cost, meaning that the research on neglected diseases (with no presence in high-income market) would not pay off. This may imply that in order to tackle the issue of the NTD, a new paradigm of how to allocate the resources is needed, both from national governments and aid agencies. From governments, reallocating the budget to the most cost-effective measures in terms of health care. Development aid agencies should consider diverting resources from tangible goods (such as infrastructure projects) to R&D projects.

Public and private sectors' role in R&D. PhRMA.

Main sources

1. Cózar, A (2009) “Un tormento llamado Trovan” in El País, retrieved from http://elpais.com/diario/2009/04/19/domingo/1240113154_850215.html.
   
2. Kremer, M (2002) “Pharmaceuticals and the Developing World” in The Journal of Economic Perspectives, Volume 16,  Number 4, pp. 67-90.
3. Lassen, L C and Thomsen, M K (2007) “Global health: the ethical responsibility of the pharmaceutical industry” in Danish Medical Bulletin, Volume 54, Number 1, pp. 35-36.
   
4. Leisinger, K M (2012) “Meeting the global health challenge: the role of the pharmaceutical industry” in Making It Magazine, retrieved from http://www.makingitmagazine.net/?p=6046.
5. Loue, S (2013) ‘Forensic Epidemiology in the Global Context: A Case Study of Pfizer and the Trovafloxacin Trial’ in Loue, S (Ed.) Forensic Epidemiology in the Global Context, Springer.

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