The High Cost of Drug Development and its Impact on Neglected Diseases in the Underdeveloped World
stc63 : November 28, 2011 9:35 am : SalubrionAdvances in biomedical technology have revolutionized the pharmaceutical industry’s ability to design therapeutics to treat disease. However, these advances also saw a significant increase in the costs of research and development that are balanced by similar increases in the costs of drugs on the market. The high cost of drug development has many impacts on global health with the end result of preferential delegation of more resources to high profit, long term drugs rather than toward the development of therapies for neglected and infectious diseases that cause high mortality and morbidity among much of the underdeveloped world.
Many factors contribute to the rising cost of drugs. The decision to pursue the development of a new drug is often a gamble, with lengthy and costly research and no guarantee of any viable results. Research and development decisions have long-term ramifications for the economic health of a company and are subject to market and governmental policy changes. First phase research consists largely of investigative work into potential targets and understanding the biochemical basis behind diseases. Chemical compounds are then developed either naturally or synthetically for the target1. Research then focuses on the pharmacokinetics of the chemical, how it affects the body, and any potential side effects. Testing begins first in tissue cultures, then animals, and eventually to human volunteers before seeking approval by the FDA. The entire process, on average, takes 7-10 years with an estimated cost of $802 million2. If approved, further expenses are needed to market the drug to healthcare providers and the general public.
As a result, pharmaceutical companies are more likely to spend on diseases that offer significant financial return in high-income countries. Diseases such as malaria, leishmaniasis, lymphatic filariasis, and dengue continue to plague the less-developed world but drug development for these diseases has been largely ignored. The World Health Organization believes this is due to three factors: failure to use existing tools effectively, inadequate or nonexistent tools, and insufficient knowledge of the disease3. Many of the drugs used to treat tropical diseases are also outdated, remnants of a time when development of tropical pharmacopoeia was driven by imperialism in the early 20th century3. It is estimated that drugs for cardiovascular and central-nervous system diseases account for 35% of the worldwide sales and 28% of new chemical entities with a combined expense of around $35 billion. In contrast, less than $70 million was spent on development for malaria, tuberculosis, leishmaniasis, and African trypanosomiasis combined3. Furthermore, 68% of new chemical entities that hit the market present little or no therapeutic gain when compared to drugs already on the market while no significant increase in the number of drugs delivered or improvement in the degree of innovation can be seen in tropical diseases3.
Thus, the competitive nature of the drug industry and the high cost of drug development have been used to justify the lack of research into diseases of the poor and the high prices of current drugs on the market. Diseases in developing countries represent too small of a market share for the private sector to invest in research and development on diseases in these countries. In 1983, the United States passed the Organ Drug Act, a measure designed to grant market exclusivity and intellectual property protection to companies who market drugs for rare diseases3. However, this act still suffers from the same market-driven logic and constraints; that is, companies are encouraged to make drugs for success in the United States, rather than in countries affected by rare or neglected diseases. Orphan-type legislation has been largely unsuccessful and is unlikely to encourage more research into tropical diseases. While there has been some debate into giving further market incentives to pharmaceutical companies to develop drugs for neglected diseases, the high costs and risk of drug research has largely impeded this approach.
A shift is needed in pharmaceutical drug research to tackle the largely ignored problems of these diseases in the developing world. 97% of pharmaceutical research and development occurs in developed countries, causing a wide disparity in the resources available for countries affected by these neglected diseases to undertake research and development3. As a result, organizations such as the United Nations Development Programme and the Drugs for Neglected Diseases Working Group have been encouraging local research and development to generate the pharmaceutical capacity to tackle the diseases in the countries themselves3. These organizations have been largely focused on building and technology transfer and promoting bilateral and multilateral development cooperation to accommodate and offer economic support as well as economic growth in these countries3. The Drugs for Neglected Diseases Working Group has also been exploring the idea of an international non-profit project to research neglected diseases, thus eliminating the market-driven logic behind the process of drug development3.
References:
1. Ogbru, Omudhome and Marks, Jay. “Why Drugs Cost So Much.” MedicineNet.com. 9 Feb 2002. Web. 19 Nov. 2011. < http://www.medicinenet.com/script/main/art.asp?articlekey=18892>
2. Adams, C.P., and Brantner, V.V. “Estimating the Cost of New Drug Development: Is It Really $802 Million?” Health Affairs, 25, no. 2(2006) 420-428. Web. 19 Nov. 2011. < http://content.healthaffairs.org.proxy.library.cornell.edu/content/25/2/420.full>
3. Trouiler, P., Olliaro P., Torreele E., Orbinski, J., Laing, R., Ford, N. “Drug development for neglected diseases: a deficient market and a public-health policy failure.” The Lancet 2006; 359(9324): 2188-2194. 22 June 2002. Web. < http://www.sciencedirect.com.proxy.library.cornell.edu/science/article/pii/S0140673602090967#ref_bib24>




