Wednesday, April 12, 2006

Clinical trials by for-profit companies are unscientific by definition

The Post reports on findings of systemic error in pharmaceutical trials sponsored by companies making the drug being tested, which lie squarely in the definition of Cargo Cult science. No one fluent in science can possibly be surprised by these results. The only question is why supposedly scientific experiments to compare the efficacy of different products are still given any thought at all; why the government acknowledges them, why any supposed scientist puts his name on them, why any supposed scientific or medical journal publishes results from them, when they are unscientific by definition. By that I mean, the definition of science includes at its core taking all possible steps to eliminate bias, to proactively investigate all possible sources of bias and do everything you can to root them out, out of recognition that human perception is slippery, and will always - always - skew interpretation of experimental results.

The Great Master said it best:

“But there is one feature I notice that is generally missing in Cargo Cult Science… It’s a kind of scientific integrity, a principle of scientific thought that corresponds to a kind of utter honesty – a kind of leaning over backwards. For example, if you’re doing an experiment, you should report everything that you think might make it invalid – not only what you think is right about it: other causes that could possibly explain your results; and things you thought of that you’ve eliminated by some other experiment, and how they worked – to make sure the other fellow can tell they have been eliminated.

“Details that could throw doubt on your interpretation must be given, if you know them. You must do the best you can – if you know anything at all wrong, or possibly wrong – to explain it. If you make a theory, for example, and advertise it, or put it out, then you must also put down all the facts that disagree with it, as well as those that agree with it. …

“In summary, the idea is to try to give all of the information to help others to judge the value of your contribution; not just the information that leads to judgment in one particular direction or another.” (Richard Feynman, The Pleasure of Finding Things Out, pp. 209-210.)

2 comments:

El Guapo said...

You paint with a mighty broad brush and on the wrong barn. By your argument any scientific research would fall into the "cargo cult" category as every researcher would carry a preconceived opinion or hypothesis.

The important issue is not "who" is doing the research, it is "how". Note Feynman referred to diligently attempting to disprove, not going in with a blank mind. It is a willingness to be disproved and accept what the data say that define scientific debate.

bryan @ shotgunfreude said...

I heartily agree with everything you say in your second paragraph, el guapo, but I stand by this post. Everyone has preconceived notions, but my point was that this kind of research setting imposes a particular, systemic interpretive bias on its researchers.

That is, the researchers depend for their livelihood on a company whose managers make quite clear that hundreds of millions of dollars, and perhaps the continuing existence of the company, may be gained or lost depending on how they interpret their data. Then, once having understood that, the researchers are supposed to clear their minds and gauge experimental results purely objectively.

Any scientist who thinks that setting could not influence her capability to interpret data objectively, on some level, is almost certainly fooling herself.

On the other hand, imagine a fantasy world with a nation that has an FDA that is not in the back pocket of the lobbyists for the entities it is supposed to regulate, and flying unicorns, and all that, where a company has to pay the FDA to go out and do the final clinical trials of a proposed pharmaceutical, and the scientists doing the clinical trials are employees of that public agency, answering to no one with the capability to make decisions on their income and future employment who also has a tremendous stake in the outcome of the trials.