Big Pharma is usually the main villain in the story when we talk about everything that is wrong with our healthcare system. The $400 billion pharmaceutical industry is rife with corruption. It has become commonplace for big players to use their deep pockets to fund and influence research and push favorable laws and regulations. All so that Big Pharma can continue to pad their profits, often at the expense of our health.
But while Big Pharma is often in the crosshairs of vocal critics, the medical device industry is quietly getting away with the same, if not worse.
Often referred to as Med Tech, the medical device industry is a separate $400 billion industry within our healthcare system. Where Big Pharma is responsible for drugs, vaccines, and therapeutics made out of chemicals, the medical device space is responsible for anything mechanical. Think of everything as simple as tongue depressors to more complex technology such as hip replacements, birth control devices, and programmable pacemakers.
While some people are aware of the problems with pharmaceuticals, few people know that the medical device industry is actually less regulated than pharmaceuticals. For a prescription drug to receive FDA approval, it must be tested on humans. Manufacturers conduct these trials and compile data that is then presented to a panel of FDA scientists. While there are plenty of areas for improvement in this process, at least there is the requirement for human clinical trials before a drug hits the market.
The same process is not required for medical devices. Suppose a manufacturer can demonstrate that a new device is equivalent to one already on the market. In that case, they can bypass human trials and easily receive a stamp of approval from the FDA.
That’s right. No human trials are necessary for a new hip replacement or birth control device to hit the market as long a manufacturer can argue that their new device is similar to something else that has already been approved. The scary part about this loophole is that a new device can receive FDA approval even if the old device it is being compared to has been recalled for safety reasons.
The Med Tech Industry is set up to make manufacturers money without protecting patients’ interests
To makes this perfectly clear, since it’s as crazy and nonsensical as it sounds, here is an example. Say a metal-on-metal hip replacement receives FDA approval. Years after the product is on the market, patients experience symptoms associated with metal poisoning (which has happened with some cobalt hip replacements). This causes a safety recall for the hip replacement. Now, another manufacturer develops a different metal-on-metal hip replacement. They can still cite that past RECALLED device to bypass clinical trials and get their new hip approved. Crazy!
It doesn’t make sense, but that is how the system is currently set up, and manufacturers love it. Since 1976, over 90% of medical devices have received FDA approval by forgoing clinical trials and instead citing older medical devices already on the market.
Scary stuff. And the problems with medical devices don’t stop at hip replacements. Permanently implanted birth control devices like Essure have caused severe complications in many women, leading to approximately 39,000 affected individuals filing Essure lawsuits. And by the way, the FDA never recalled Essure.
The key takeaway? Big Pharma usually catches most of the heat when criticizing our healthcare system, but Med Tech is just as much of a villain in this story. Which one is ‘worse’ doesn’t matter. What matters is that we all take care of our health as best we can today to avoid relying on our healthcare system tomorrow.
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