Human Sacrifice for Science
No one doubts the importance of testing new drugs before they come to market. Much of the early testing involves mice, and we don’t usually care when participating mice meet untimely deaths. Rarely do we even hear about the mice that sacrifice their lives for the good of scientific progress.
But it’s a whole different story when human participants begin losing their lives. That’s what happened to nine out of more than 350 people participating in clinical studies aimed at testing the effectiveness of a new drug to treat Alzheimer’s disease.
The fate of ELND005
The potential new weapon in the fight against Alzheimer’s is referred to as ELND005, or scyllo-inositol. After the U.S. FDA awarded the experimental drug Fast Track classification back in April, 2009, testing of 3 different dosages began. The highest dosage studied is 2,000 mg, administered twice a day. The second-highest dosage studied is 1,000 mg, also administered twice a day. A third and much lower dosage of 250 mg administered twice daily is also being studied. Some participants received a placebo.
After nine deaths and the development of other adverse reactions deemed serious, developers of the experimental drug made the decision in December to halt study of the two highest dosages. They did this even though no direct connection between the higher doses and the complications had been established. They cited their commitment to patient safety as the reason.
The two companies have decided, along with the Independent Safety Monitoring Committee, to continue unchanged their studies on the lowest-dose ELND005. All parties involved feel confident the progress that’s been made so far combined with the known safety and tolerability issues associated with the lower dosage warrants continued study.

This got me thinking
That decision made me think about the remaining participants and how they’re reacting to news of these deaths.
• Are they scared to continue?
• Do they cross their fingers each night and hope that they’re receiving the placebo?
• Have they been given the option of opting out?
• How much of what’s going on do they even comprehend?
I don’t know about you, but the idea of participating in clinical studies to test an experimental drug’s effectiveness scares me. It got me wondering whether I’d ever knowingly put my health at risk in that way. So far I haven’t been willing to do this and I wonder, does this mean I’m weak? Selfish? Uncaring?
And what about people who do participate? Do they do so because they have no other options and nothing to lose? Does this make them heroes? Do they receive any special acknowledgment?
There probably are people that participate for the money. But maybe people do it for no other reason than the satisfaction they get from helping find cures that will one day eliminate the suffering of millions.
And now I want to know
Have you ever participated in a clinical study?
If so, what was your motivation?
Labels: Alzheimer’s disease, clinical study, death, FDA, United States

















