Think Malaria, TB, HIV/AIDS, and the latest: Ebola. Different from “Orphan” Diseases (in which the affliction occurs in developed countries, but has an extremely low prevalence), neglected and tropical diseases are mainly characteristic of underdeveloped regions.
Both classifications present a conundrum to pharmaceutical companies. Conditions with very small populations, and conditions that may in fact affect large populations-but whom lack the ability to pay for the medication, don’t exactly inspire large investments. Remember that the underlying goal of all pharmaceutical companies is to in fact: profit, or more specifically, recoup the return on the investment required to bring a drug to market. This is increasingly difficult to do, however, as regulatory bodies such as the FDA in the U.S. and the EMA in Europe have applied increasingly rigorous standards for safety and efficacy data requirements in order to actually license a new medication. Likewise, the costs of R&D have increased disproportionately to GDP or CPI growth.
It is in fact, very difficult nowadays to get a medicine through the R&D pipeline all the way to market. The Projected cost of drug development is cited around 4 billion USD, and can be as much as 11 billion USD, meaning each drug must make a projected 500,000 USD per year in order to make up the initial investment costs. Of all drugs in the development pipeline, only one in 5,000 drugs makes it to market, and out of the small number of successful products (in that regard), only 1 in five recoups its initial R&D investment. As you can imagine, this makes for a stringent Pharma industry in terms of resource and funding allocation.
The obvious case at hand, is the Ebola vaccine VSV-EBOV, which was effectively shelved for ten years without sufficient funding to bring the drug to market. In other words, this vaccine wasn’t seen as investment worthy, despite showing 100 percent effectiveness in monkeys. Now, with West Africa undergoing a humanitarian crisis, and over 5,000 claimed to the death toll, the vaccine which has received the needed capital in the form of aid, is finally entering safety testing in humans-finally making production of the vaccine possible. While this is a start, there is still a long way to go. Vaccines in particular must undergo the strictest safety and efficacy testing of any type of medication. There is no room for risk, as this is no experimental medication to be doled out to cancer patients.
This isn’t Contagion. You can’t always bypass regulatory protocols and take the proverbial injection for the team. In some cases, you just have to realize a broken system when you see it..and do what you can to fix it. Ideas? I have a few.☼
Without Lucrative Market, Potential Ebola Vaccine Was Shelved for Years
Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, et al. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol 2010; 66(1): 39-48.