NorGeorgeVille
There is tag line that is often used derisively to comment on over-hyped biomedical research reports of a pre-clinical nature.
That line is:
"...In mice."
The point being that early stage biomedical research has not yet been demonstrated in humans where the ultimate result is often very different or, most often, not as impressive in real world conditions where all extraneous variables cannot be tightly controlled for.
Which, of course (institutional PR machinations aside), is actually the way things should work in that first you must demonstrate proof-of-principle with pre-clinical experiments, many of which are often carried out in mice, before you can even start to think about moving on to clinical testing where the first hurdle is safety followed by accuracy and efficacy.
In the case of the Theranos debacle, the details of the pre-clinical work are, to put it charitably, fuzzy. More importantly, the folks running the place never demonstrated any clinical safety, accuracy or efficacy, whatsoever.
In fact, when it came right down to it the Theranos braintrust, as the courageous whistleblower Erica Cheung detailed, deliberately masked safety concerns, inaccuracies and lack of efficacy by removing and/or ignoring data generated by their 'technology' that they did not like (or did not match that produced by proven machines).
Ultimately, the result was the following:
...“There were over a million (blood) tests that patients had which were fraudulent”, said Eric Topol, a cardiologist and founder and director of the Scripps Research Translational Institute (La Jolla, CA, USA), where he is a professor of molecular medicine. “That is the most egregious part.”...
These fraudulent tests led to real world/real patient consequences, a small sample of which were detailed at the trial of Elizabeth Holmes:
...During the 15 week trial, 29 witnesses took the stand, but only three were patients or doctors. Two witnesses testified about getting Theranos tests that incorrectly detected HIV/AIDS and prostate cancer. A third person testified that a Theranos blood test she took at an Arizona Walgreens pharmacy showed a high level of a hormone indicating she was having a miscarriage. When the test was repeated twice by a different laboratory, the results showed that her pregnancy was still viable...
Now.
It is important to understand that Ms. Holmes', who this week was sentenced to serious jail time, was not officially convicted of defrauding or harming patients.
Instead, she was officially convicted of defrauding a bunch of rich people that she bamboozled into investing shovels full of money in her fraudulent company with its fraudulent technology that should have never been used for real world patient diagnostic purposes in the first place.
Personally, I choose to recognize the 'unofficial' verdict based on the defrauding of the real world patients.
________
Personally, I also found all the media reports that pegged this as a 'Silicon Valley story' where it was common to 'fake it till you make it' extremely egregious. This was not first faking and then ultimately making a better way to stream a movie or book a vacation home. This was about patient diagnosis where fakery cannot ever be tolerated.
Ms. Cheung's story is a truly amazing and even more truly courageous one...Tyler Shultz, who was the grandson of one of the rich investors, also did the right thing. However, given his family situation Mr. Shultz was never left hanging over the edge like Ms. Cheung was, especially when the Theranos-hired lawyers and PI's started to come after them for speaking the truth.
.
.
No comments:
Post a Comment