FDA and Foreign Aid?

Ages ago we talked about foreign aid, particularly in regards to public health, as a help or a hinderance. I have all sorts of opinions, anecdotes, and even personal vendettas relating to this topic. Rather than subjecting readers to my inner madness, I will use this blog to share a specific example of the debate over the cost-effectiveness of foreign aid.

My personal interest in the field of global health is in what many call "neglected tropical diseases", a term that can be remixed with other terms like "poverty" or other similar ideas. We have all been bombarded with the war on malaria, HIV, TB, polio, etc. thanks to Bill & Melinda Gates, Partners in Health and the like, but there are many other diseases that we in the US consider rare, such as helminth infections, that millions of people suffer from despite the relative ease of curing and/or preventing them.

A recent FDA public hearing on neglected tropical diseases (September 23, 2010) prompted me to dig around the FDA website for info on the FDA and the international-medical-drug-money-all of the above scene. I found a slightly outdated document (June 23, 2010) that explains the FDA's role pretty thoroughly. http://www.fda.gov/NewsEvents/Testimony/ucm216991.htm

The FDA is primarily responsible for insuring that drugs coming into the US from other countries are regulated, and it has little to do with providing foreign aid. One important way the FDA is involved in international medical aid is by providing incentives for drug development. This is true of the FDA in all drug development research, but in the case of neglected tropical diseases, which are considered "rare" in the US, even more financial incentives are necessary in order for companies to invest in R&D. The document I read describes the use of the 1983 Orphan Drug Act, which provides funds for R&D of treatments for rare diseases ($15.2 million in FY2010), as well as exclusivity rights beyond those for normal drugs. In 2009 an amendment was passed allowing priority review for treatments pertaining to one of the 12 named neglected diseases of poverty. In addition, the FDA works closely with the WHO, especially recently, to change its focus from just controlling the quality of imports to producing and approving priority medications that are developed in the US but whose target populations are abroad.

Lovely little summary over. My thoughts on this are mixed. I did leave out some details about collaborations and review processes etc, but my main question, one that I have struggled with as a researcher myself, is: Are the enormous amounts of money, time, manpower, paperwork, and other resources that go into R&D really efficient and/or effective? Malaria was wiped out in the US almost 100 years ago not by vaccines or pills but by draining marches and soaking the country in DDT. Not that I am advocating this as a strategy now, but I think it is vital to remember that money may be better spent on simpler solutions than drug development. Not only is lab research expensive and low-yield, relying on drugs rather than public health- oriented solutions often causes even larger problems, such as multi-drug resistant strains.

While I recognize that R&D is inherently wasteful, I also partially believe that it has become a necessary evil. Especially now that resistant strains of many diseases have developed, eliminating pandemics will require fancy drugs to kill off the last strains. Also, when applied correctly, new drugs can be highly effective (check out river blindness and ivermectin). So, let the FDA spend money checking out new drugs, because it works really well at times.

At the end of the day, it is not that drug development should be excluded from budgets. What needs to happen is a re-allocation of resources toward education and delivery, both in the donor and recipient country. This job obviously does not fall under the FDA's responsibilities. What the FDA is doing by incentivizing drug development for rare diseases is a first step, but it is one that must be monitored (protecting a drug discovery can make that drug inaccessible and expensive) and supplemented with a more direct approach to foreign aid.

Aid and Development in Question

I think one would be hard-pressed to find an individual not in favor of a world with less HIV/AIDS, malaria, tuberculosis. Who wouldn't want to eliminate such broad-scale suffering? These diseases have proven to wreck so much damage economically, politically, and socially that in terms of the poverty and health level of many nations, development is hopelessly retrograde or stagnant unless something can be done to address the underlying health issues. As one aid organization's website notes with regard to Sub-Saharan Africa, "The most obvious effect of [the HIV/AIDS] crisis has been illness and death, but the impact of the epidemic has certainly not been confined to the health sector; households, schools, workplaces and economies have also been badly affected."

At a fundamental level then, it is difficult to see how anyone would be opposed to efforts taken to combat the major diseases affecting regions of our world, especially considering their broader implications. In reality, however, the delivery of aid is much more complex and contested than one could initially imagine. The Global Health Leader's Program discussed some of the issues that may arise with developmental aid in their September 20th seminar focused on health and development. Drawing from our broad personal experiences (volunteering in the Peace Corps, international service projects, internships with the WHO, etc.) and considering the insights of scholars like Dambisa Moyo (author of Dead Aid) we came to realize that achieving any sort of lasting success in improving health in any location requires local acceptance, cultural relevancy and sustainability among a number of other necessary qualities.

We talked also about the Millennium Development Goals set forth by the United Nations. Of note, the 6th Millennium Development Goal specifically aims at some of the major health crises in the world, namely HIV/AIDS and malaria. Other goals, such as reducing child mortality (#4) and improving maternal health (#5) also seek worldwide development by addressing the health status of (often) the most precarious individuals in the population: women and children. With specific objectives to be achieved by 2015, the MDGs represent a continued effort by the international community to move toward prolonged and sustainable development.

But in the end, I wonder. Moyo goes so far as to call for an aid-free Africa. What would that look like? Would it really lead to development? And are the MDGs achievable, effective and not imperialistic? I only hope that we can tell... before time will tell.