As an orthopedic surgeon with over twenty years of private practice, I remain dedicated to nurturing the deep trust that my patients place in me. Two recent articles from The New York Times caught my attention that question the integrity of the doctor-patient relationship, one of them focusing heavily on orthopedics.
In the Jan.13 article titled, “Can Your Hip Replacement Kill You?”, Jeanne Lenzer uses Johnson & Johnson’s defective ASR XL metal-on-metal hip as the launching point for a sobering discussion about “the untested and largely unregulated medical device industry.” In the second article, “Do You Trust the Medical Profession?” from Jan. 23, Dhruv Khullar, MD, looks more broadly at the eroding relationship between Americans and our institutions dedicated to maintaining public health and safety.
I see significant interplay between the use of evidence-based practices to ensure that physicians are good stewards of technology and the importance of prescribing appropriate treatments to restore public trust in our profession.
Lenzer refers to the device industry as “the Wild West of medicine.” While this may be a bit hyperbolic, she correctly identifies two main contributors to the lack of scientific rigor: (1) the FDA’s 510(k) provisions allowing manufacturers to bypass clinical testing for devices that are “substantially equivalent” to an existing product, and (2) channels that allow companies to bypass testing for devices by telling the FDA that they’ve just made a minor change to an existing product.
These “minor changes” can have tremendous impact on sensitive implant design. Every experienced orthopedic surgeon can name an expensive new technology from the past 20 years that we as a profession electively adopted, only to learn that it was no better — and sadly, maybe even worse — than what it replaced. While our intentions were good, the results were not optimal. This is why I emphasize the importance of using rigorous clinical evidence to evaluate whether new technologies actually offer superior outcomes.
High-quality clinical evidence provides transparency into which products are comparable based on data and attributes, rather than using marketing collateral. In the ASR XL hip example, there were years of data demonstrating the efficacy of metal-on-plastic hip implants, but that didn’t stop many of us from rushing to use the newest — albeit unproven — metal-on-metal technology for hip replacements.
As Lenzer points out, there appears to be a desire within the current administration to change FDA regulation of the device industry as it relates to new product approval. Whether or not you agree with the rationale behind loosening restrictions, the potential reduction in regulation makes the work of physicians and health systems ever more important. In an era when it’s literally impossible to keep up with the flood of medical literature, having an outside source to synthesize the evidence and apply it to an organization’s specific physician-level utilization data can significantly impact the care provided.
When it comes to patient safety, vendor-initiated recalls and FDA warnings are often too late in identifying potential device harm . Often, recalls are not issued until significant damage has already occurred, as we saw with the metal-on-metal hip replacements described by Lenzer. As a result, the burden falls on physicians and hospitals to proactively identify and manage safety risks. Predictive analytics, power by machine learning and a comprehensive database of adverse events can help organizations identify and replace potentially dangerous devices and drugs.
As Khullar’s article makes clear, there are factors beyond device selection that have undermined public trust in the medical community. I hope that the medical community continues to take a long, hard look at the issues raised in these recent articles. If we take it upon ourselves to make more evidence-informed decisions and to play an active role in device and drug safety monitoring, we’ll be taking a big step forward.
John Cherf, MD, MPH, MBA is chief medical officer of clinical decision-making solutions provider Lumere.