How many lives are lost because the FDA uses double blind rather than decision making under uncertainty as the gold standard including the data for metformin which is a decision making under uncertainty 99% for life extension but could never even be tested and approved because it would cost over 1 bill to test.

The gold standard also applies the "precautionary principle", thus avoiding the political fallout of another Fen-Phen. They make it uneconomic for sponsors/manufacturers to do research in life extension, delayed senescence, cognitive enhancement, and other outcomes that require the "proactionary principle".

Alston Mabry writes: 

I still remember the first time I heard the term "evidence-based medicine", and how my first thought was, "As opposed to what?" Upon investigation, I realized that what we have is essentially "experience-based medicine", i.e., doctors do what their experience, and the experience of their teachers, tells them is the best course of action. Then I read articles about how hospitals resist the tracking and publication of the performance of, say, their surgeons, because they don't want to lose patients if they look bad.

There is so much data produced by our whole healthcare system, and the bulk of it is lost. The whole country is a pharmaceutical experiment, but I wonder if we capture even a small fraction of the useful data.

Dylan Distasio writes:

Agree 100%. I think the gold standard has done more to set back the areas highlighted than any others, although they (along with the legal environment) also make it extremely hard for MDs to experiment with cancer protocols. There was a great article awhile back (which I can't find at the moment) highlighting the fact that early (by early I mean 1960s-70s) creative protocols based on taking calculated chances and empiricism could never even be attempted in today's the "proactionary principle".

Charles Pennington writes: 

Speaking out of ignorance here, but I have the impression that a very disproportionate amount (>80%?) of important world pharmaceutical R&D is done in the US. Are there any familiar prescription drugs that we take here that were developed and/or marketed by Japanese companies? I can't name one. Obviously there are some big European pharmaceutical firms, but it still seems like the US is the center of mass, and even more so if one is considering "biosimilars" — seems like the US really is even more dominant in biotech

Is this impression correct, and if so, why?

(I imagine it's true in spite of the FDA rather than because of.)





Speak your mind

2 Comments so far

  1. Bart Madden on May 29, 2017 11:38 am

    For over a decade, I have been pushing a Free To Choose Medicine proposal to offer a legal path for early access to new drugs that have passed safety trials and demonstrated initial efficacy, Interestingly, Japan has recently passed legislation that implements the principle of free to choose for regenerative medicine drugs. The huge popular support for Right-To-Try state legislation suggests that the time may have finally arrived to replace the FDA’s paradigm of “safe and effective drugs” (regardless of the time or cost involved) with “better drugs, sooner, at lower cost”—a new paradigm rooted in consumer choice and competition.

  2. Jose on August 1, 2018 10:20 am

    Dear Mr. Niederhoffer,

    I have come across this post as I was checking out any of your posts related to biotech, after reading chapter 16 of “Practical Speculation” (”An Amiable Idiot in The Biotech Revolution”).

    May I ask you, would you recommend a high school student to get into biotech?

    My bet at the moment is a major in biotech, and a minor (or self taught) in computer science (data science/machine learning), but still trying figure out how much media hype is influencing my perception that these fields have huge positive potential for the near future.

    Thank you for your book, and posts.

    Greetings from southeast Spain.



Resources & Links