Tough Bones



This is a blog all about bones and joints.


I am an experienced orthopaedic surgeon. I trained at The University of Western Ontario and McMaster University and was prior Faculty at Stanford for a number of years in Palo Alto and with the VA. I took a research sabbatical with a funded grant to the FDA to evaluate the precision of outcome metrics in orthopaedic surgery as well as engaged in device and combination product regulation and research. After this I was plucked from the FDA and recruited to Amgen as a Medical Director for Global Bone Health Development. And now, I am in private practice here in the Bay Area in Los Gatos and San Jose.


My experience allows me to have a broad overview of clinical care that few surgeons have, from research to drug and device development, to regulation, approval and clearance for use in the US, to direct patient care. I know this imparts a unique perspective that I can share with you, my patient, and allow me to challenge myself as well as other providers beyond traditional training. You cannot learn regulation by reading a book – being an insider in the FDA facilitates a shift in thinking that is not teachable – you can only experience it. Seeing a novel device for the shoulder being brought to the FDA and having to critically appraise its clinical value and review its clinical data and then to approve it and then subsequently implant it into a patient after approval is remarkable – and only after implanting it in a patient did I realize that nobody I personally know has had that particular experience or satisfaction.


When I completed training, I thought I knew a lot about bones and joints. Joining the FDA made me realize how much more I needed to learn. I established a Bone Quality Working Group to help guide our sense of bone quality and strength. I held a large, very successful workshop at the FDA on the minimally important difference in patient reported outcomes which brought together for the first time a diverse array of experts in the field to the same table to help understand the limitations of data, our measurement tools in orthopaedics, as well as bias, considering all aspects of care from provider to patient. We published several papers subsequently that are imparting a transformation in orthopaedic outcome metrics research.


Joining the FDA allowed my learning curve to go almost vertical. Even working in an academic practice did not prepare me for the level of learning needed. It was fantastic. The last time I felt like such a sponge was in my first year of university. I realized the limitations and barriers that we as clinicians and academics create within our solos of care – it was a fundamental deficiency of shared learning. At the FDA, I saw everything. Data, and tons of it, from across the globe. It shattered the glass ceiling and floor and opened my mind towards possibilities of innovation and care that I could never have reached sitting in Palo Alto. Joining Amgen, further enhanced the pervasive integration of intellectual pursuit that is very pragmatic. How to take a product from bench to bedside in a reasonable efficient, cost effective manner and provide care to the masses. I knew I had to return back to full time clinical care because my patients needed me, and I had so much more to share with them now.


Interestingly enough, when I did return to private practice, I immediately found that I held a completely different approach to care, remarkably infused with outcome and data sharing in an open manner that even I at first did not realize how I had changed my thinking. It is unfathomable to me how we can be trained physicians and surgeons without the experience that I had. It was priceless. That is why I feel it is so important to have conversations with patients about all aspects of care along their path towards recovery.

I want to share with my patients and establish an honest conversation within the community of patients and doctors about bone diseases, fractures, arthritis and injuries, work, sports or medicolegal. I want to share evidence and outcome metrics as well as their limitations and bias that exist and how we as providers incorporate that into practice as well as how we share that with our patients.


My goal is to share various perspectives and concepts and try and relate them to real practical examples to help patients and the community at large understand the importance of having toughbones. There is a saying, ‘no bones about it’ – however that is a medieval reference relating to the bad notion that finding bones was bad. In this case, it is all bones about it – toughbones – your bones are the most important aspect of your health – even if you had a functional heart – if you had no bones, you would not be standing.


Fragility fractures are a great example of why bones matter and why we need tough bones. It was not until I joined the FDA and began to question what I knew and what I was learning in a more meaningful manner that it occurred to me that as much as I thought I knew about bone strength. I pushed the envelope by bringing in experts for regular discussions on bone quality and strength through the working group and then when I was recruited to Amgen, the learning continued. I realized that even as surgeons, we were limited in how much we understood bone quality and strength and how fragility fractures are the biggest epidemic currently. Weak bones break easily! We need tough bones. I will discuss this and many other topics but the notion of improving our bone strength and quality was the primary impetus for starting this blog.


See you next time,

DocMirza

www.orthosynthesis.com

© 2018 by OrthoSynthesis. Proudly created by MediaMedia

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