Could a startup founded by two guys in their 20s change the way medical researchers study patients? The Food and Drug Administration is open to the possibility.
Flatiron Health began as a small New York tech company trying to use real-world data from patient electronic medical records to replace more traditional clinical trial data. Then it raised $328 million, launched a modest collaboration with the FDA to study the use of its so-called “real-world” data in 2016, and entered partnerships with just about every major drug firm. Last year, it was acquired for $1.9 billion by the Swiss drug giant Roche Holding.
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There are enough ammoral industry insiders to help hoodwink the FDA about the relevance of this ill gotten data. The FDA is still behind the times when it comes to evaluating any of this, and will surely act against the interest of public health, and benefit the industries here. The FDA has still not recognized how this data is misleading, and the lack of scrutiny has led to worse health outcomes. It is no wonder the US has the worst health outcomes in the developed world, and the most expensive healthcare.
The US also has the most overweight individuals, which is a huge risk factor for a number of diseases. Most people in other developed nations walk to public transportation or bicycle to work more than Americans as well. If you are aware of a study that takes such factors into account, please respond with a link. Thanks!
this article does not explain how they gained access to medical data to use in their study. Did they have to get written permission from each patient? Would people refusing change the final outcomes for the study?
It was probably de-identified. Otherwise, it would have had the restrictions you mentioned.