27 May 2008

Thank a Third-worlder for those pills.

The Mormon-Utah-depression-prescription drug use meme seems to be everywhere these days. In some cases, it appears as a legitimate and serious concern, and occasionally as a farce (see second paragraph, third line).

My own issue in this post is not Mormons and prescription drugs, by prescription drugs in general, and more specifically how we come to obtain them. I recently wrote a student note for a forthcoming issue of the Duke Journal of Comparative and International Law on the international ethical codes which apply to pharmaceutical companies and CROs (contract research organizations) as they conduct human clinical trial all over the world. Most of these codes and the principles contained therein are inspired by the Nuremberg Code that emerged from the Nazi War Crimes trials following WWII. I will not go into further detail about the codes, but will point you to my forthcoming article if you want to know more. However, the most important of these codes has historically been the World Medical Association's (kind of like an international AMA) Declaration of Helsinki.

Earlier this month, the FDA announced that it would no longer follow the Declaration of Helsinki. The likely effect of this change will be to push more pharmaceutical clinical trials abroad, to areas with large populations of the poor and sick, such as Eastern Europe, Africa, and India. Anyone who has seen the movie The Constant Gardener is probably familiar with this phenomenon. Americans are notoriously unwilling to undertake the risk of clinical trials, even though the drugs produced are primarily for their consumption. The pharmaceutical companies and researchers are being given more leeway to self-regulate the conduct of these trials with very little oversight either at home or abroad. The FDA does not conduct its own ethical review of such studies, and medical personnel in foreign countries are generally not equipped or educated to conduct such a review; further, the financial incentives given to them by the drug companies and CROs puts the objectivity of any such review seriously in doubt.

More specifically, any tests of improved treatment protocols may now be tested against a placebo rather than against the best existing treatment, which is what the Helsinki Declaration would have called for. That means people in the Third World who believe that they are receiving treatment for serious illnesses may in fact be receiving...sugar pills. The use of a placebo is designed to make the comparative results of clinical trials clearer and more impressive. But at what moral cost? All this so that Americans can enjoy the fruits of such research. (Pharmaceutical companies are under no obligation, and generally do not, provide the tested drugs to the former test subjects once the clinical trial is concluded.) The moral distributive economics of this situation are unacceptable to me- one party bears all the risk (primarily chosen because of their poor health status, poverty, and accessibility) while another enjoys all of the benefit.

As Latter-day Saints, we acknowledge that all of us are God' children. The life of my American neighbor ought not to be preferred over that of an African, Indian, Pole, Czech, or Vietnamese. The use of these people to provide members of rich and privileged societies with life-saving drugs, while the risks and long-term consequences to their health are ignored, is a moral outrage and a sad continuing legacy of imperialism. It needs to stop. So, at the very least, Mormons (and everyone else) should say a prayer for the Third-worlders when you pop those pills tonight.

If anyone is interested in learning further about this topic, see Sonia Shah's book, The Body Hunters, which was a major jumping-off point for my own research and writing. Ms. Shah posted on another blog about this development here.

7 comments:

  1. Adam, I think that the issue you point to is deeply troubling. So much of what we take for granted often can be traced back to pain felt by those in the developing world. I am not sure what can be done about it, but you are right in focusing our attention on this. In a global world, it becomes very difficult to know how to love your neighbor, who your neighbor even is, what it means to go an extra mile, and so-on and so-on. I believe that I those living in the developing world are something. Where I get stuck is figuring out what that something is exactly. Anyways, I am glad you are keeping me thinking.

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  2. This is really disturbing. I don't know how many more of these kinds of revelations about regulatory agencies under the current administration I can take. We like to talk about the Nazis when it comes to reasearch and human rights violations, but we here in the US have our own checkered history. This administration turns my stomach. November can't come soon enough.

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  3. AHL, thanks for posting on this. Certainly troubling. Any activist groups?

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  4. Jupiters,

    Sidney Wolfe and Peter Lurie at Public Citizen are the only folks doing work specifically with issues like this that I am aware of.

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  5. Thanks for the post. This is a very important, yet very troubling, issue.

    While I'm not very familiar with the pharmaceutical industry, I can comment on a somewhat parallel issue: manufacturing American goods in third-world nations. Your post made me think of the several Chinese people I've known who have worked in factories that produce American goods. Just as American drugs are tested in poorly regulated circumstances that are often detrimental to the foreign test subjects, so are American goods manufactured in poorly regulated factories under pitiful conditions.

    I recognize that moving industries abroad may help stimulate growing economies, and there is some truth to the maxim that "a rising tide raises all boats." But oftentimes, the conditions in which our goods, be they toys or medicines, are produced are downright shocking and inhumane. These practices would never be permitted on U.S. soil, but so long as they take place on the other side of the world, most American consumers don't feel much of an ethical dilemma when it comes to buying cheap clothes that were manufactured in a Chinese sweatshop or pills that were tested on Indians.

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  6. Thanks Steve.

    I guess the Mormon angle on this (given our knowledge of the preexistence and fatherhood of God)is- on what principled grounds is the life of my countryman to be valued more highly than that of a foreigner? I understand that stronger moral obligations run to our immediate friends (voluntary association) and our family (quid pro quo), but who is Joe Schmo in Iowa to me? Or at least, who is Joe Schmo in Iowa to me and why is he more important than Xin Xinyang in China? This is a topic with which I perennially struggle with in terms of American politics, which clearly preferences American lives over others, on no better basis than the right to vote.

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