Friday, April 05, 2019
So, what will the FDA's secret hidden database lay bare?
NOTE: By now, if you haven't heard of the secret database the FDA has been keeping to help companies hide adverse events, I'd say you are not keeping up! I will supply a couple of links for you to peruse to get yourself up to speed.
1. It is typical for controversies to take a political bent. But here is an alarming example of something that started with one administration, and sustained through several.
2. There are something like 780+ federal agencies, that we know of. Just the potential of the spread of this type of bold unethical behavior, that will go unpunished is just jarring!
3. Congress is completely asleep at the wheel!
4. THIS ONE IS KEY: How many company executives know about this, have participated in this, and what are the implications of all this?
What I Expect We Will Learn
1. Just how many medical devices and their manufacturers been accessing the database?
2. What type of adverse events were being hidden?
3. The relationship between adverse events that we were made aware of, previously and what was in the database. Do we get a chance to just sum them up and say, "well, we thought this device had 5 adverse events per year, and now we know it was 25 per year because we found thata on an average, 20 were being hidden per year?"
4. What if certain types of adverse events were hidden from us? What if injuries were made public, but deaths hidden?
5. What if companies got preferential treatment in terms of access to the database and how was this decided?
6. To what extent can we answer the question: how far was the true harm to patients?
1. Imagine how many start ups could have germinated to solve issues caused by devices that people falsely believed to be better than they are!
2. Imagine how many patients could have chosen alternate treatments or devices. One also has to wonder how many credible lawsuits were not filed owing to the fact that the evidence was hidden!!
3. Doctors could have better cared for their patients, and provided them with adequate warnings, alternates or protection.
4. The FDA is meant to protect us. Medical Device Companies are supposed to be ethical. And now, it is anyone's guess how deep the loss of credibility is going to go!!!
There is more to come
This database raises far more questions and alarms. I am sure in the days, weeks and months to come, we will discuss more of these issues, as details become apparent. Currently, we know something like 3X the data was hidden, in just a year, per Star Tribune. Who knows what the real depth of the problem is.
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1.Star Tribune: http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/
2.The Kaiser Health News Report: https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
3. Image of Woman: https://www.pexels.com/photo/black-and-white-black-and-white-depressed-depression-568025/
4. Image of Right and Wrong: https://pixabay.com/photos/ethics-right-wrong-ethical-moral-2991600/
5. Image of Seated Person: https://stocksnap.io/photo/95TESM9499