People get injured in North Carolina in diverse ways.
• Maybe you suffered debilitating metallosis after a metal-on-metal hip replacement surgery.
• Or perhaps your spouse suffered a cardiac event after his bicarbonate levels spiked when he was treated with GranuFlo or NaturaLyte at a Fresenius dialysis clinic.
Stories like these are disturbing. If you’ve been injured — if you’ve suffered through the injury experience and its aftermath — you know how dreadful it can be.
But why DO we see so many defective drug and medical product cases? What’s at the root of it?
Here’s some provocative speculation.
Companies and medical equipment suppliers pump out innovative new products at a rate that’s far FAR too rapid for health agencies and consumer advocates to vet effectively.
Obviously, no one thinks that the FDA’s drug approval process is perfect. But perhaps the reason it’s so imperfect (or at least part of the reason) is that system is being asked to do a kind of due diligence that it simply cannot do given its financial pressures and time constraints.
For instance, certain drugs can create long term, subtle and chronic harm to the human body that superficial science can’t pick up on right away. Our health authorities may also just lack the funds, scientific savviness and time to figure out which drugs will have which subtle chronic health effects on which population groups.
This means that patients on these drugs are much like guinea pigs.
There’s another issue here, too.
Let’s say that a drug gets cleared. Five years later — after the drug manufacturer has invested $2 billion into it — new science reveals that the drug causes heart attacks or kidney failure or some other medical catastrophe in a certain subpopulation.
That drug company has invested tremendous amount of time and money into that product, and thus the business will inherently want to resist attempts to regulate that product.
The point is that the root cause of many of these problems — with companies like Fresenius, Stryker, etc– might be the very system that we use to evaluate and restrain how and when new products should be introduced to the market.