FDA and Political Pressure

POSTED ON IN Industry News BY Christopher Centeno


Interesting story in the NY Times about how FDA admits being pressured by congressmen to approve a knee meniscus replacement device (Menaflex) that was shown in clinical studies not to work. As I've said before, I think we have the world's most expensive drug and device approval system that actually fails to produce safe drugs and devices. The problem is, that while we hold out very high standards, big pharma and device manufacturers routinely game the system. In this area, I think we could learn from our European colleagues. Their focus is placed heavily on safety, generally letting the market determine what's effective. In the US, this would mean FDA could use it's limited resources to ensure safe products and devices sold in interstate commerce and the private insurers and Medicare would decide what to cover based on the research available. As I have blogged before, we can't truely fix the Healthcare system without reforming all of it's parts and pieces. As for Menaflex, it's an interesting idea. You place a biologic collagen scaffold shaped like a meniscus to replace all or part of the meniscus. Why didn't it work? I can think of lots of reasons. Just off the top of my head, the fact that there are no cells placed to engraft to the scaffold (which is where mesenchymal stem cells would come in) and poor blood flow in the area to allow cells to survive would be two reasons. In addition, with such limited native healing capability in this area of the knee, sutures are unlikely to hold this in place for very long. In addition, most of these patients with large parts of their meniscus removed, have other problems in the cartilage and bone due to the initial meniscectomy surgery. There's also significant scientific doubt that many of these meniscus tears are causing pain anyway, so trying to fix them for pain relief may be a lost cause.

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