The biggest threat to orthopedics


Orthopedics is a thriving industry, but it is not without its threats. 

Charles Rosen, MD, an orthopedic surgeon at UCI Health in Orange, Calif., connected with Becker's to answer, "What is the biggest threat to the orthopedic industry?"

Note: This response has been lightly edited for length and clarity.

Dr. Charles Rosen: The greatest threat to the industry is the independent validation of new medical products. Most new product research papers for passing FDA clearance are written by industry consultants in overall industry-sponsored studies. The literature has shown that such papers usually have a majority of positive results, about 75%, whereas later independent review by researchers without any potential conflicts of interest averages about 50%. Often complications are swept under the rug and studies citing positive results of clinically insignificant endpoints are cited as evidence of effectiveness. Data is often manipulated, such as "lost to follow up," being excluded from results instead of treated conservatively as negative results. The list goes on.

The second largest threat, in my opinion, to the industry would be the appropriate and long-needed repeal of the pre-emption law for FDA-approved products. Namely, any FDA-approved product is immune to any liability, known or unknown, after release. This is even if the study has subsequent complications that were just covered up and results in morbidity and death in patients. Since the companies are now legally immune to liability, who do you think takes the heat from this when the complications occur? The doctors. We become the fall guys and gals with malpractice lawsuits due to bad products that were assured were the latest and the greatest. There is no industry from toys to food that is not held responsible for knowing defects that result in harm. Yet the only industry not held to scrutiny — though it involves no less the ultimate of life and death — is the medical industry. The ridiculous notion that holding companies liable for bad products would impair research and innovation is laughable. It would only risk profitability of products that are bad or questionable and improve safety profiles and hold companies manipulating data accountable. That is the way it should be because the FDA does not keep us safe. Its budget to regulate industry is 50% paid by the industry it regulates.

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