So a clinical trial designed to study safety shows that a treatment produces significantly more death and survivable complications is presented to a group of people with several hundred patients. In the group with no treatment there was a 25% complication rate and with the group getting treatment there was a 75% complication rate. However, the mortality between the two groups was higher in the treatment group, more people died, but those numbers were not statistically significantly different. Because the complications were more frequent, but considered “manageable,” and the mortality did not reach statistical significance more people are going to be treated.  A lot more people with a much larger clinical trial.

It begs the question, how many people need to die to prove that unsafe is statistically significant. Or the other way to ask it; is your death significant?

Why am I concerned about this you ask? Well because the same technology was used in Europe several years ago in a larger clinical trial and killed significantly more people than in the control group. The lucky ones got the placebo and the dead ones got the experimental treatment. This technology is not new, but it is new. Let me explain. What happened is some technoweenies and patent attorneys made some tiny changes in the technology, packaged it again in new wrapping paper and tried again. While I am fully in favor of testing technology to improve the human condition there needs to be a moral justification for pursuing such technology.

The people pushing this work are physicians who know how to do medical research on patients. They have also spent a lot of their political and professional clout to get this technology going. I sympathize with any researcher who has worked for years to develop a research program. It takes many years, tens of years, to see research to fruition, but if it is not working; walk away. It is hurting society because some physicians and scientists who because of their power and prestige in the research community can keep killing their patients in the name of science. Sorry for your luck if you put all your eggs in one basket, or to mix metaphors, bet all your money on one horse, but if that horse loses, you need to accept defeat. Now others are paying for your dead horse. Your patients are dying because of your hubris.

That is just said.

Yes, since I am soap-boxing, I’ll admit that I have had projects that do not work and I can tell you I worked long and hard on two projects that I needed to let die. I was lucky, or dare I say smart, in that my research portfolio is diversified so that I walked away from one technology into another. Many smart people seem to be not so smart and invest everything they have intellectually into one research avenue and if that dead-ends, their career dead-ends. Tough, stop killing people in the name of science, because that makes the rest of us, who are only trying to help people, look bad. Quite frankly what I see happening in some research programs makes me sick.

Here is an idea. If you think your research is so good and needs to go forward, prove it to everyone by doing pre-clinical studies. Do what is morally right and don’t skip a step. That is what many projects are required to do under most circumstances. But because you are an expert in one field, and can push your favorite thing forward, you stay in your comfort zone to save you time and completely miss a step.

You want your legacy to be a successful device and successful company; personal wealth and fame from your one discovery. But you risk is a legacy of tombstones all with the epitaph, “the placebo group were the lucky ones.”