Mio Dio! This week, I watched one of the most horrifying depictions of legal manipulation, intimidation and racketeering that generates a multi-billion dollar profit – the FDA organizzazione .
The Netflix feature movie, “The Bleeding Edge,” is a sickening look inside the agency’s area that is supposed to ensure the health of US citizens. Specifically, it is the FDA’s medical device approvals & clearance area. Unlike the more stringent requirements process for pharmaceutical drugs, medical devices are routinely pushed through a rubber stamp cycle.
This documentary should be mandatory viewing for every US citizen before they are in a position seeking medical help for any internal injury, disease or functional problem. Don’t break out the popcorn (or pizza). The movie is not entertaining. It is disturbing if not traumatizing, particularly for anyone who has already been permanently disabled or physically compromised from internal devices such as Essure, pelvic mesh or hip replacements. Chilling video of the FDA’s Essure approval hearing from over 15 years ago includes jokes, laughter and an acknowledged lack of the clinical evidence presented by Bayer on the device’s safety and efficacy – all culminating in an overwhelming approval of the toxic device. The subsequent tens of thousands of adverse reactions reported were ignored for over a decade, while Bayer profited handsomely.
Other devices, including the cobalt ball & joint hip replacement that caused metal poisoning, are reviewed. The key takeaway is that in the absence of a resilient oversight process: you need to dig deep into your own research around anything proposed to be inserted into your body. Know when to refuse offers that sound too good to be true, or just plain good. Physicians are compensated to use the devices that pharma salespeople are commissioned to push. Further up the chain, the capos – or rather big Pharma CEOs, push through approvals with the FDA in their pockets much like a corrupt police force or judge who can be bought off. Funny enough, Europe again shines in terms of putting people above profits. This could be due to the incentives inherent in a socialized health insurance system wherein the government profits by keeping people as healthy as possible. Many of the devices allowed in the US are banned in Europe due to lack of testing and overall safety.
In the US, the incentive is for profit by way of corporate revenues and taxes, giving big Pharma the upper hand in lobbying to push as many products out into the market as quickly as possible and for the FDA to do its job as a foot soldier and approve medical devices as quickly as possible. Even if individual employees do not, then they are allegedly rubbed out by way of being demoted or fired.
If only we could find the balance in our free market health care system with a framework that rewards testing, safety and quality – as in Europe – while maintaining a person’s choice and access to the healthcare of their choice without a government capo running the territory. Until that time, we are faced with a ruthless underboss by way of the FDA, that lacks the power to say no to offers that big Pharma knows won’t be refused.
