As I said, the law allows this and it creates a crazy quilt of risk because if you live in one area, presumed consent may not be permitted while if you live in another, it may be. There is also a movement afoot to have presumed consent govern things like organ transplantation. That’s a very frightening thought to me. The idea that it may one day be the law that if you pass away, your organs — your kidneys, your liver, your heart — may all be taken from you without anybody having to ask your family’s consent.
As you can see, presumed consent is not consent at all. That’s the pattern we see, that all these forms of “consent” do not actually involve people giving their consent. Presumed consent, community consent, deferred consent — none of these offer you the opportunity to give or withhold your consent. This erosion of informed consent is a very serious issue and it is becoming more and more widespread. The American people should be worried about it.
Is there evidence of ethnic or racial disparity regarding organs being taken without meaningful consent?
Yes, but I want to stress that even though there is racial disparity, this is an issue that can affect everybody. African Americans, for example, constitute 12.3 percent of the people in this country. Even though they have a significantly higher percentage of organs taken without adequate consent, still the majority of organs taken in this way are from white people. Taking of organs is much less common than taking of tissues, and there is a dramatic racial disparity in the taking of tissues. There’s the infamous case of the Doheny Eye Bank Institute, where they took corneas from many, many people. These were bought and sold while the families had no idea they had been taken. In some other cases, tissues have even been taken from people who happened to know enough to say, “I don’t want my tissues taken.”
Eighty percent of these tissues came from African Americans. This is not unusual. Many “presumed consent” areas are in cities, especially large cities that are heavily African American. Philadelphia is one. The bodies that are taken in this way tend to be bodies that are taken to the coroner’s office. Whose bodies go to the coroner’s office? The bodies of “the friendless poor.” Who are the friendless poor today? Homeless people. The coroner’s office also sees people who died in homicides, and the rates of deaths due to homicide have skyrocketed among young African American males, to the point where they may occur at seven or eight times the rate of whites the same age.
Research on People in Poor Nations for the Benefit of People in Affluent Nations
Can you speak to the issue of American or other largely Western pharmaceutical companies doing research overseas in poor areas, using weaker standards of patient protection than what is generally present in the United States?
Yes, but first I want to what we mean by patient protection. The Declaration of Helsinki, issued by the World Medical Association, is the predominant regulation governing research by Western and Japanese researchers in the developing world. Under Helsinki, protections for people in the developing world have actually been weakened over the past decade.
A lot of the language has been “clarified” in a manner that reduces the protections. I’ll give one example, which is that it used to stipulate that when a Western researcher goes to a developing country, under most circumstances they can’t use a placebo for a serious illness if a safe and approved drug exists. If you take people who are HIV positive, for example, or at risk for becoming HIV positive, previously you couldn’t give one group an effective preventative medication and give the other group a placebo, like a vitamin.
This is starting to bring to mind the German medical experiments in World War II.
Previously, you would need give both groups medications that are known to work and the one you’re testing will be evaluated in comparison to the other one.
Now, that regulation was changed in the past decade; currently it says that you’ve got to give everyone the standard of care in a clinical trial, but it’s the standard of care according to the country where they live. The standard of care in the countries where people in the developing world live is often substandard and is often nothing. So now, according to these changed rules, it is perfectly acceptable to give people in clinical drug trials nothing that is effective. That is not permitted in Western countries, only in developing countries.
Have drug companies shifted more and more of their research to poor countries?
One-third of all clinical trials by pharmaceutical companies are now conducted abroad, and that means in poor, developing countries. Why are they conducted in Nigeria and India? They are conducted there because researchers can do higher quality research much more quickly, much more cheaply, and with medically naïve patients, which is an advantage scientifically. In those countries, you can easily find people who have never taken a particular drug or have never taken the drug you’re testing it against. And, according to the New England Journal of Medicine, these are higher quality trials than can be conducted here for the same price. Also, the longer the trial goes on, the less money the company can make on the drug [because of the time limits on patents]. So what all of this means is that the developing countries are doing us a huge favor. They’re providing people for studies that could not be conducted here, in less time for less money. I think that we owe them.