Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick…

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best disinfectant, Biomet, chrome cobalt, Cobalt chrome, Conflict of interest, DePuy, Dr. Fehring, hip, hip resurfacing, jacobs zimmer, Medtronic, Research, science

Friday, March 8, 2013

Steven L. Frick, MD

Central Program Commitee Chair, 2013 Annual meeting AAOS

Dear Dr. Frick,

Please consider this an open letter. Sunshine remains the best disinfectant and I remain concerned that unless the faculty of the panel that will address the complications of metal-metal hips at the rapidly approaching annual meeting of the AAOS is changed hundreds of thousands of patients implanted with metal-metal hips might suffer harm from the delayed diagnosis and treatment of the local and systemic complications of chrome-cobalt metallosis.

Figure 1: Symposium at AAOS 2013 addressing metal-metal hip complications.

 

Table 1: Membership of 2013 panel, their arthroprosthetic company allegiances and their intrarelationships.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (moderator)	Biomet	Royalties, employee or consultant, speaker’s bureau.	President of the Hip Society, metal-­‐on-­‐metal modular hip advocate. Chair of the annual meeting hip program committee. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐ metal hips.
MA Mont	Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate has resurfaced 1600 hips. Hired gun by Stryker to promote the Corin metal-­‐metal hip resurfacing. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
TP Schmalzried	DePuy, Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate and design surgeon of the ASR. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, employee or consultant.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with Dr. Schmalzried. President of the AAOS. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
Young Min Kwon	None declared.	Past research work supported by multiple arthroprosthetic companies.	Foundational researcher on the periprosthetic complications of chrome cobalt metallosis. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips. Least conXlicted of the faculty.
SJ MacDonald	DePuy, Stryker	Royalties, employee or consultant, research support.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with JJ Jacobs.

I sincerely apologize for mistaking Dr. Fehring’s arthroprosthetic company allegiance as being Biomet rather than DePuy. DePuy as well as Biomet has a large metal-metal hip liability. DePuy’s ASR has been formally recalled from the market and was implanted in 92,000 patients. DePuy’s Ultramet modular metal-on-metal product is still on the market and is part of DePuy’s popular “Pinnacle” acetabular system. Dr. Fehring has likely assisted DePuy with the development of this product line although he is not the “thought leader” on the metal- metal bearing option. His work with DePuy has likely brought him into close collaboration with Dr. Schmalzried who also consulted on the “Pinnacle” system and was the primary design surgeon of the ill fated ASR. DePuy has already placed a 5 billion dollar down payment on the ASR remediation.The metal-metal option for the “Pinnacle” system appears to have the same problems as the “ASR” and many more have likely been implanted.

I appreciate that Dr. Fehring has recognized and published on the complications of the “ASR” and has also contributed to publications addressing monitoring protocols for patients implanted with metal-metal hips.The Alaskan experience indicates that monitoring criteria developed by Dr. Fehring in collaboration with the other symposium panel members may be more protective of the arthroprosthetic companies from which these surgeons have received millions of dollars than the patients that been implanted with those companies metal-metal hip products.

Experts on Conflict of Interest (COI) in the professions might conclude that only Dr. Kwon is qualified to objectively address the complications of metal-metal hips. He is but one of six, his influence is likely to be muted by the “group-think” of the five more conflicted members.

The weakness of the proposed monitoring criteria of the publications that you reference is that blood cobalt determinations are recommended only for patients with notable symptoms at the hip and the possiblity of the systemic complications of unidentified cobaltemia is minimized. Our experience indicates that all patients with metal-metal hips should be contacted and their blood cobalt levels determined. Patients with blood cobalt levels above10 mcg/L merit a through neurologic and cardiac evaluation. The neurologic and cardiac complications of cobaltemia are insidious, progressive, and potentially disabling. Patients can develop these complications without sentinel hip symptoms.

Most of our severely cobaltemic patients, incuding five with disabling neurologic toxicity, had minimal symptoms at the hip. Two of our toxic patients had no hip symptoms although both had severe periprosthetic tissue damage.

I am concerned that the 2013 symposium on metal-metal hip complications will be a repeat of last year’s. I witnessed that event and found the panel to be hopelessly entangled with industry and unable to adequately recognize or disclose those entanglements.

Table 2: Membership of 2012 panel, their arthroprosthetic company allegiances.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
WJ Maloney (moderator)	Wright Medical, Zimmer	Royalties from Wright Medical Received $423,412 from Zimmer in 2007	Also does medical legal surgeon and industry defense work.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, consulting fees.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology, Vice President of the AAOS.
CA Engh	DePuy	Royalty income in 2010-­‐11 > $ 350,00 Consulting income 2010-­‐11 > $ 27,000	Has resurfaced > 500 hips and did studies initially supportive of DePuy’s modular metal-­‐on-­‐ metal hip.
TP Schmalzried	Design Surgeon ASR, DePuy, Stryker	Royalties from ASR 2010-­‐11 $3.4 million	Has resurfaced > 600 hips. Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with JJ Jacobs.
DW Murray	Biomet, DePuy, Smith & Nephew, Stryker, Wright Medical, Zimmer	Royalties from Biomet and Smith &Nephew Research support from all listed	Believes that metal levels are of academic interest and only indicates revision of metal-­‐on-­‐ metal hips for those with major symptoms at the hip.
BL Penenberg	Wright Medical	Consulting fees and Royalties	Involved in the design of Wright Medical’s modular metal-­‐on-­‐ metal

 

I must disagree with your statement that the present process for determining the CME content at the annual meeting is acceptable. The choice of such a commercially conflicted panel to address the largest medical device failure in history points to the contrary. The inclusion of Dr. Schmalzried on multiple panels at this year’s and last year’s meetings seems inappropriate. He is the design surgeon of the ASR and continues to promote and perform metal-metal hip resurfacing. It is extraordinarily unlikely that Dr. Schmalzried could either recognize or reconcile the true frequency, severity, and cost of the periprosthetic and systemic complications of chrome-cobalt metallosis. Placing Dr. Schmalzried on any panel at an orthopedic meeting is akin to a mariners convention featuring the captain of the Costa Concordia as the keynote speaker on the topic of inter-island navigation.

I have similar concerns about the inclusion of Dr. Mont. It seems that much of the purpose of the symposia at the 2012 and 2013 meetings is to reassure surgeons that hip resurfacing remains a viable and safe arthroplasty option. There is no Level 1 evidence that hip resurfacing has advantage over a stemmed metal-on-plastic one that is proven safer, more durable, and less expensive. For the hip program committee to continue to place hip resurfacing advocates at the podium of AAOS CME events is a disservice to marketable surgeons, arthroplasty candidate patients, society, and the million patients already implanted with metal-on-metal hip arthroplasties.

Why would the hip program commitee place commercially conflicted hip resurfacing advocates at the podiums of the world’s most influential orthopedic meeting where they are likely to minimize the periprosthetic and systemic complications of chrome-cobalt metallosis?

Table 3: Membership of 2013 hip program commitee and their arthroprosthetic company allegiances.

Surgeon Committee Member	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (chair)	Biomet	Consulting fees, royalties, and speaker’s bureau.	Also President of the Hip Society, Fellow of GA Engh and TH Mallory. Has published studied supportive of modular metal-­‐on-­‐metal hips with large heads.
KL Garvin	Biomet	Royalties
DW Manning	Biomet	Consulting fees and royalties.
JB Meding	Biomet	Royalties
JW Mesko	Stryker	Consulting fees
DE Padgett	Stryker, Mako	Royalties, consulting fees, stock or stock options.
JC Kudrna	DePuy, Innomed, Convatex	Royalties, consulting fees, stock or stock options.
WB Macaulay	Wright Medical	Research Support	Vocal hip resurfacing advocate has performed > 100 hip resurfacing.
AH Glassman	Zimmer, Stryker, Exatech, Innomed	Royalties, consulting fees, stock or stock options, speakers bureau	Has coauthored multiple papers with CA Engh.
MJ Archibeck	Zimmer		Not declared but DOJ disclosure notes he received 14K from Zimmer in 2006 trained by or is colleague of JJ Jacobs
PE DiCesare			None declared but is on the faculty at HSS and a colleague of Dr. Su a major advocate for Smith and Nephew’s BHR resurfacing.
AJ Ayers
JF Fetto
RH Gonzales
JM Passick

 

It is notable that two-thirds of the hip program committee panel members are financially entangled with arthroprosthetic companies with huge metal-metal hip liabilities.

This committe not only controls the content at hip replacement related symposia and instructional course lectures, it also controls the content of the hip replacement related scientific program.

I submitted applications for the symposium on metal-metal hip complications, an instructional course lecture of the management of the metal-metal hip implanted patient, and three scientific papers on the systemic complications of chrome-cobalt metallosis, the histopathology about failed metal-metal hips, and on the explant analysis of failed metal-metal bearings. These submissions were rejected

by a hip program committee rife with Surgeon Industry Conflict of Interest. I wonder how many other submissions addressing the underappreciated complications of the metal-metal hips might have also be excluded from the program of the 2013 meeting.

I spoke with Dr. David Langton at last years annual meeting. He is arguably the World’s foremost authority on the periprosthetic complications of metal-metal hips. He has also had great difficulty in getting any of his many submissions on metal-metal hip complications accepted for presentation at AAOS annual meetings.

I am worried as much about what will not be presented at this year’s meeting as what will be presented. I agree that not all the members of the selected symposium are dyed in the wool metal-metal hip advocates but they are all entangled with surgeons that are, or with arthroprosthetic companies that might be bankrupted by their metal-metal hip liabilities.

Please forgive my passion in attempting to advocate for the million patients implanted with metal-metal hips and those that might unwittingly be placed at risk due to ongoing hip resurfacing. I am troubled that the million metal-on-metal hip implanted patients that are at risk for asymptomatic periprosthetic tissue loss and an insidious, reversible, and potentially disabling neurologic illness are not being appropriately monitored by their surgeons. This equates to patient abandonment.

Please accept my sincere apology for misindentifing Dr. Fehring’s commercial arthroprosthetic affiliation. It is difficult to keep straight who works for who.

Dr. Jacob’s has generously offered to present my work on arthroprosthetic cobaltism in my stead in two weeks. If this communication seems rushed or contains minor inaccuracies, I apologize, I am preoccupied with interviewing the 24 patients of my series to assertain their present status so that I can supply Dr. Jacobs with a current manuscript on the incidence of cobaltemia and cobaltism in 24 Alaskan patients with 26 revised metal-on- metal hip arthroplasties.

Sincerely,

 

Stephen S. Tower, MD

Fellow AAOS, Affiliate Professor, UAA, WWAMI School or Medicine

 

Letter from Dr Frick

Dear Dr. Tower,

As Central Program Committee Chair for this year’s AAOS Annual Meeting, I have appreciated your concerns about the processes used to construct our program. Our committee and organization are taking your concerns seriously to strengthen and improve what I believe is already an excellent system, one that produces an annual meeting that provides the best educational experiences in the world for orthopaedic surgeons.

While President Tongue and the Presidential Line speak for the organization, I am responding personally and on behalf of the Program Committee about some of the inaccuracies in your recent letters. Like many passionate individuals trying to effect change, if your message contains information stated as fact that is not true, the rest of your message loses its intended effect.

First, you question the qualifications of Dr. Fehring to speak on the complications of metal-metal THA, and list him as a consultant for Biomet.     As a pediatric orthopaedic surgeon, I am not as familiar with the literature on THA as you are, but as I was the program director for the residency program in Charlotte and Dr. Fehring served on our faculty, I know him well and am very familiar with his practice and academic work. He does in fact have potential conflicts of interest, but as a consultant for DePuy, not Biomet, and his work for them involves metal- polyethylene THA (thus perhaps his conflict is that he would like for metal-metal THA to fail). He does not have any design or consulting involvement with metal-metal THA, has not advocated for metal-metal THA, or clinically used metal-metal THA, and his published and presented works (including at AAOS) involve the complications associated with metal-metal THA. I performed a brief literature search and quickly found the 5 publications listed below by Dr Fehring on complications of Metal-metal THA in the past two years. It is thus difficult for me to see how his presence on the symposium panel does not “balance” it to provide a perspective on the possible complications of metal-metal THA.

1.         Beaver WB, Jr., Fehring TK. Abductor dysfunction and related sciatic nerve palsy, a new complication of metal-on-metal arthroplasty. The Journal of arthroplasty. Aug 2012;27(7):1414 e1413-1415.

2.         Kwon YM, Jacobs JJ, MacDonald SJ, Potter HG, Fehring TK, Lombardi AV. Evidence- based understanding of management perils for metal-on-metal hip arthroplasty patients. The Journal of arthroplasty. Sep 2012;27(8 Suppl):20-25.

3.         Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. The Journal of arthroplasty. Sep 2011;26(6 Suppl):14-18.

4.         Fehring TK, Fehring K, Springer BD, Masonis JL, Dennos AC. Comparative analysis of periarticular osteolysis in modern total hip bearings: a minimum 5-year study. The Orthopedic clinics of North America. Nov 2012;43(5):e14-16.

5.         Griffin WL, Fehring TK, Kudrna JC, et al. Are metal ion levels a useful trigger for surgical intervention? The Journal of arthroplasty. Sep 2012;27(8 Suppl):32-36.

The third surgeon you questioned in your letter is Dr Lombardi.       I do not know Dr. Lombardi personally, but see that he is listed as a coauthor on a paper on the “perils” of metal-metal THA (article #2 above)

Last, you question whether the potential complications of metal-metal THA will be covered in the symposium, and complain that the AAOS is somehow suppressing information about these potential complications to the detriment of patients. Below is the application for the the symposium on metal-metal THA that was selected for presentation at     the 2013 Annual Meeting. Reading this, it is difficult for me to see how this presentation will not address the potential local and systemic complications of metal-metal THA. Also for your information, your symposium on metal-metal THA was not the only other symposium on metal-metal THA that was not selected by the program committee. In fact, President- elect Jacobs also submitted a symposium on metal-metal THA that was not graded as highly as the symposium below, and thus it also was not selected.

Basic Science Consideration: This symposium addresses important issues such as understanding metal-on-metal failure mechanisms, current recommendations, clinical presentation of adverse soft tissue reactions, a systematic diagnostic algorithm, and utility of specialized tests including metal ion levels and cross-sectional imaging studies. Integration of clinical expertise from national faculty with best available clinical evidence from research and national joint registry data into the decision making process to address clinical challenges relevant to every day practice and identify areas for future research.

Learning Objective 1: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors.

Learning Objective 2: Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data.

Learning Objective 3: Recognize a low threshold to perform a systematic evaluation of metal-on-metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

Learning Objectives All: For Report: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors; Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data; Recognize a low threshold to perform a systematic evaluation of metal-on- metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

In conclusion, I strongly disagree with you about the symposium that will be held on metal-metal THA in Chicago. It has a highly knowledgeable and qualified faculty, and they will address the learning objectives noted above. As educating members of the AAOS about the potential adverse effects of metal-metal THA seems to be your primary objective, it is difficult for me to see how that objective is not met by the above symposium.

Sincerely,

 

Steven L. Frick, MD

2013 AAOS Annual Meeting Central Program Committee Chair

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