Interview with Harriet Washington (Part IV): Erosion of Informed Consent and Using Poor Patients to Test Drugs They Cannot Afford to Purchase

What do the people in the developing countries gain in the bargain?

When the trials are completed and the medications are approved and marketed, these people don’t have access to the medications. Why not? Well, companies will tell us they can’t afford them; these are poor people in poor countries. I have a problem with this argument because, in very important ways, to take Africa as an example, the image of Africa as a poor continent is absurd.

Please explain.

Africa is a rich continent. That’s why it has always been the target of colonial acquisition. That’s why you have nations, right now, fighting over the spoils — the diamond mines, other jewel mines, oil, gold, natural biodiversity with medical utility, natural resources of all kinds, the flora, the exotic fauna. It’s a very rich continent. Its people’s poverty is directly tied to colonization, rape and depletion. There isn’t any question about this. Jeremy Bentham, who is held up as the father of utilitarianism, had something to say about this. He said, “No man should profit from his own misdeeds.” And that’s exactly what’s happening here.

We are denying people access to medications that could not have been devised and tested without them. Then we point to their poverty, which we caused, as the reason. So on the balance sheet — both economic and ethical — we are the ones who owe them and not the other way around. And yet the rallying cry from pharmaceutical companies is, “Don’t blame our patents, blame the poverty in the developing world.” That’s obviously not an argument that I find persuasive.

Is there anything else that we haven’t discussed that you would like to add?

One of the things I mention in my book, which is understandably problematic for many people, is that when it comes to solutions for the problems caused by drug patents, I think the best solution would be to repeal Bayh-Dole. I fully understand that this is not going to happen anytime soon and it may not happen at all. But I do think what would be a good first step.

There are several other steps that we should take to remedy this problem. One that I’d like to showcase is cooperation between foundations, people who are astute in business, researchers and pharmaceutical companies. There have been several ventures that use the old model, the pre-1980 model of research, which I call the “back to the future approach,” that have been successful so far. This is a workable model.

Proposed Solutions: Theory and Practice

The number one example is the Health Impact Fund. Yale philosopher Thomas Pogge partnered with Calgary economist Aidan Hollis to propose market based solutions that will distribute medicines where they are needed most and reward the pharmaceutical companies commensurate with their impact on global health. Partnering with Incentives for Global Health the HIP proposes that pharmaceutical companies should take their payments from a pool to which many entities contribute – governments, foundations, and the World Health Organization.

This fund should be drawn upon for profits by the industry, but only when they devise a medication that has a significant, positive impact on human health. They would do this by directing their efforts at the diseases that cripple the globe most dramatically — malaria, sleeping sickness, tuberculosis, HIV disease, worm infestation. The diseases that affect many, many people around the globe should be the targets.

When they come up with an effective medication or other treatment for these diseases, the money should be proportional to the number of lives they’ve saved. So if they come up with a cure for sleeping sickness (which actually has happened, but companies couldn’t make any money marketing it), and they save the lives of, say, 700,000 people in Africa, then their payment should be based on having saved those 700,000 lives. Let’s say there’s Serious Disease X, and it affects people in affluent countries in North America and Europe. If they save 700,000 lives in North America and Europe, they should also get the same amount of money.

So every life has equal value.

Yes. I love this model because every life is worth the same. In today’s model, the lives of people in affluent countries are worth a great deal and the lives of people in the developing countries are worth nothing.

Another model, one which has already shown great success, is that brokered by the Bill and Melinda Gates Foundation, which has partnered with organizations involved in vaccine design, the governments of developing countries and the WHO. They have pooled resources and found ways of devising needed medications such as vaccines, so that these can be administered very cheaply and very effectively in the developing world. That’s more involved than just manufacturing cheap vaccines, although they’ve done that. They took one vaccine that costs $7 in the United States that now only costs 50 cents in Nigeria.

But more to the point, the Gates foundation has organized the provision of medicines in forms the developing world needs. For example, vaccines in this country require refrigeration. But in parts of Africa, India and Asia, electricity for refrigeration is not always something one can depend on. The Gates Foundation has accomplished the distribution of vaccines that do not require refrigeration and they can do it on a large scale. What’s more, pharmaceutical companies are involved with these projects and that’s really important because we need them to generate our medications.

But their profits and their patents should not be the focus of healthcare design and delivery. Patients’ lives should be the focus. I think these new models need to be embraced, endorsed and underwritten by our governments, so they can replace the exploitive model that we have today.