Shades of Tuskegee?

Ummm.....

Realizing that everyone (myself included) is still reeling about Bush's "throw down the gauntlet on our democracy" moment yesterday, this one deserves our some of our attention nonetheless.

In today's Chicago Sun Times was printed this rather understated health news:

In an isolation ward of a Baltimore hospital, up to 30 volunteers will participate this April in a bold experiment: A vaccine made with a live version of the most notorious bird flu will be sprayed into their noses.

I think we need to parse this article just a bit.

Step One: The easy part is parsing the phrase "most notorious bird flu"? There is no confusion about this one: the "most notorious" bird flu is H5N1, the avian flu strain that has earned the fear and loathing of not only much of the Asian Peninsula but even landed on American policians' radar because of the fears of a pandemic rivaling the lethal Spanish Flu Pandemic of 1918-1920, which is reported to have killed between 20 and 50 million people worldwide, depending on whose numbers you go with.

Step Two: The NIH lead scientist supervising this clinical trial describes this upcoming trial as "high risk, high reward" and says that it has the potential to lead to information that will save tens of thousands of lives.

OK, there are two ways to interpret the "high risk" part (the high reward part seems clearly explained.) The first is that this is a "high risk" experiment because this type of experiment has never been tried before so the hypothesis (i.e. nasal spray delivery of live virii is an effective method of developing anti bird-flu antibodies") is high-risk, i.e. meaning high likelihood that it will be disproven. But that interpretation is debunked by the article itself - the article says that this type of delivery system has had a high success rate in other contexts.

So the most likely meaning is the other one: this experiment is "high risk" for its subjects. As in "the subjects people have a very high risk of problems arising from this experiment, even if we learn lots about HN51 nasal vaccines that can help lots of others".

Given this, why is that same article repeatedly trying to reassure us with the words "It should be safe"? If it's safe, it is a low-risk experiment, right? The use of the words "high risk" make no sense.

Not until you think about the Tuskegee Syphilis Study, anyhow.

Finally the article says that this clinical trial is being conducted in "a Baltimore hospital." I admit that this is the part that caught my attention.

Baltimore, as in Baltimore, Maryland. Yes, THAT Baltimore, Maryland. The one that as of the 2000 Census was 64.3% African-American. The one that, as of the 2000 census, had more than 22% of its population under the poverty line. Where 31% of the population has less than high school diploma to its educational name - 39% cannot read at a 6th grade level.

Interestingly, neither the Sun Times article nor the fuller AP article published by the Washington Post yesterday say *which* Baltimore hospital.

In contrast, when discussing the previous moribund-virus trial of the "nose spray" delivery system for last year's H92N bird flu trial, the author readily identifies the research location as having been "Johns Hopkins Bayview Medical Center" (itself located in Baltimore) as the site. But the writer does not say that the H5N1 experiment is being conducted at either Bayview (the logical place, given its preeminence in medical research) or University of Maryland Medical School in Baltimore, the place where volunteers for H5N1 trials (using inactive virii) are being recruited. It just says "a Baltimore hospital".

Why not identify the location of this particular H5N1 human trial? Can it be because both the likelihood of bird-to-human transmission and lethality of H5N1 makes H9N2 look like an extremely rare summer cold?

Why would anyone want to conduct a clinical trial of a potentially lethal virus in such an area? How do you ensure informed, non-coerced consent in a research population in which so many poor and functionally illiterate people exist? How do researchers ethically ensure that their subjects truly understand what they are signing up for, as is required by law?

Or are those serious bioethical concerns precisely the reason that this live-virus study is being done in Baltimore somewhere *other* than the most logical place: the Johns' Hopkins Bayview Medical Center, which is a research and teaching hospital (an expensive to actually be a patient at, as are most teaching hospitals, and therefore likely to be treating a well-insured, well-educated and well-informed clientele?)

Yet, the article does not disclose *which* Baltimore hospital. Even though it would be quite easy, if this experiment was also being done at Johns Hopkins, to simply say "Johns Hopkins." The article does not say that, however.

And so I'm admitting that I wonder who the 30 (actually 60, since assuming it is double-blind research you need 30 people getting placebos to be able to test anything.) are, where they come from - and whether they, like the Tuskegee boys, are truly being informed about the "high risk" side of this "high risk, high reward" experiment. Since informed consent problems continue to challenge the bioethics community -- particularly with low literacy and senior citizen populations --despite the clear requirement that all medical subjects truly understand the nature of what they are being asked to do when they participate in a clinical trial, I admit I worry that the "30" will not truly understand that they are taking, "voluntarily" the live H5N1 virus into their bodies. A virus that has a mortality rate of more than 50% in humans, when transmitted from bird to human. I wonder about whether these subjects will really be truly informed that the "high reward" of this study - possible avoidance of a world-wide pandemic - may come at the "high risk" of themselves.

Given that there is much concern in bioethics circles even today about whether informed consent practices truly result in informed consent when you're dealing with poor, possibly illiterate populations in India, the spectre of Tuskegee and Nazi experiments still fresh in bioethicists' minds, I hope someone takes the same care to assess these issues in connection with NIH's present work. I hope someone remembers, when exposing these people to such a lethal virus, that:

Unless the rights of those who participate in clinical trials and their ability to get the best treatment in case of injury or infection are guaranteed, the trials will not be fair even if they yield useful scientific results.

Let's hope that they understand more than what Ms. Evers' Boys (who were actually Miss Rivers' Boys) understood about what was happening to them. Let's hope they are told something more than just it "should be safe."