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Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

By Stephen Tower,

Orthopedic SurgeonAffiliated Professor UAA WWAMI School of Medicine

 

Dear Dr. Jacobs,

Please consider this an open letter.

Your prompt reply to my concerns about Surgeon Industry Conflict of Interest (SICOI) and the Continuing Medical Education (CME) content at the upcoming annual meeting of the AAOS addressing the periprosthetic and systemic complications of chrome-cobalt metallosis is greatly appreciated.

I am aware of your many contributions over the past 25 years to the literature that supported the reintroduction of the metal-on-metal class of hips, the regulatory processes at the FDA that allowed for these devices to be implanted, and to the CME content of AAOS sponsored meetings and publications that persuaded American surgeons to select metal-metal hips over safer options in one-third of their patients over the course the past decade. You have consulted for Zimmer and Wright Medical; arthroprosthetic companies whose MoM liability exposure might exceed their gross capitalizations. You continue to hold stock options in Implant Protection, a company whose worth might soar with the awareness of the frequency and severity of the systemic complications of periprosthetic chrome-cobalt metallosis.

Your belief that a brief separation from industry derived income makes you an impartial authority on the complications for metal-metal hips now plaguing tens of thousands of American patients seems at best self deceptive. However, of the five surgeons selected by the hip program committee to address metal-metal hip complications in Chicago only Dr. Kwon is less conflicted that you are. Dr. Schmalzried, with whom you have collaborated, was paid by J&J 20 million dollars to design the ASR. The ASR was implanted in 92000 patients, has been withdraw from the market, and the ASR is likely to cost J&J of about 15 billion dollars. It would be unreasonable to expect that Dr. Schmalzried could reconcile the nature, severity, frequency, and impact of even the periprosthetic complications of chrome cobalt metallosis much less the systemic ones. When I last spoke with him he was still unaware of fifty years of case reports of cobalt poisoning from industrial exposure, the use of a cobalt beer additive, and the medicinal use of cobalt.

Dr. Lombardi and Dr. Fehring have likely been paid millions of dollars to promote Biomet’s arthroprosthetic products. Dr. Lombardi is the president of the Hip Society and is the chairman of the hip program committee that rejected my application for the Symposium, an Instructional Course Lecture, and three scientific papers addressing metal-metal hip complications. The majority of the members of the hip program committee are Biomet consultants and only several committee members have no declared SICOI. Biomet is another arthroprosthetic company whose metal-metal hip liabilities might exceed its capitalization.

Given that you have been a consultant to Zimmer for many years and that your focus of interest is metallurgic it is likely that you are, in part, are responsible for the design of the Durom. This case might interest you.

Thursday’s revision was a Durom implanted for 6 years, the patient had no symptoms at the hip. He was referred to me because his naturopathic leaning primary provider was aware of the potential for metal-metal hip related cobaltemia because my work is better recognized locally than nationally. His blood cobalt was in excess of 10 mcg/L on multiple occasions. His new neurologic and cardiac problems since his Durom implantation include impaired memory, weight loss, brain atrophy, urinary urgency, ataxia, progressive deafness, motor-sensory polyneuropathy, diastolic dysfunction and carditis. Although he had no symptoms at the hip he had a large mixed pseudo-tumor with moderate loss of hip capsule, severe proximal femoral lysis, and minor loss of hip abductors. Although the implants were optimally positioned the head shows a defined wear ellipsoid and multiple “hard stops” indicating material deformation from edge head contact. There was no bone ingrowth into the shell and most remarkably evidence of marked corrosion and fretting at the innermost taper junction of the head and neck.

Tower - IMG_0321

Had this patient’s doctors followed present FDA recommendations for following patients implanted with metal-metal hips this gentleman’s cobaltemia, likely neurologic and cardiac cobaltism, and progressive periprosthetic tissue damage would likely have gone undiagnosed and might have progressed beyond remediation. I believe that you may have had a role in formulating the FDA’s rather tepid monitoring criteria.

Tower - IMG_0323This is just my most recent case. The number of metal-metal hips revised in our series is now at about 25, most have been notably cobaltemic, and about one-third appear to have been systemically toxic. In most instances we have metal levels, histopathology, and explant analysis. The case histories, the correlation of metal levels to systemic toxicity, the periprosthetic histopathology, and explant analysis were the subject of the three scientific papers that were rejected by Dr. Lombardi’s hip program committee. The detail and findings of the expanding Alaskan series is well beyond any I saw presented at last years annual meeting.

I appreciate your offer to present my research in Chicago. I would prefer to present it myself. Given that I am unlikely to be allowed near a podium I will forward the full updated series to you, piecemeal, one case report at a time followed by an analysis of the series as a whole. Since peer review of papers submitted for publication is done be the same industry entangled surgeons that determine what will be presented at meetings I will also web publish the information as I release it to you in “Blog” format. This appears to be my only means to limit the harm of neglected complications in hundreds of thousands of metal-metal hip implanted patients.

As you are aware I have been expressing concerns about the metal-metal hips to industry and to the Presidential Line of the AAOS since 2007 and to the FDA since early 2010. I now regret that I had not expressed my concerns more publicly. Given the barriers that I have experienced in presenting or publishing research counter to the interest of the arthroprosthetic industry it appears that the internet and the press might be the only means to convey relevant information to medical providers and patients.

Those that present CME content at meetings are allowed to influence the audience well beyond the merits of their research. That is how metal-metal hips were popularized. It would seem that the goal of the symposium on metal-metal hip complications in Chicago ought to be to educate the rank and file orthopedist not to further implant metal-metal hips and to recognize the early manifestations of chrome-cobalt metallosis so that the arthroplasty can be revised to one without chrome-cobalt components while the patient’s periprosthetic tissues are intact and before the patient experiences a decline in neurologic, cardiovascular, or endocrine function. If Dr. Schmalzried, Dr. Lombardi, and Dr. Fehring remain on the symposium panel those goals will not be optimally met and hundreds of thousands of patients might experience preventable harm. Surgeons that have promoted the metal-metal hips and been compensated millions for their efforts have every reason to be in a state of denial about the frequency and severity of the periprosthetic and systemic complications of chrome-cobalt metallosis.

Freeing three spots on the panel would allow for the addition of faculty that would further the idealized goals of having the symposium. Dr. Kevin Bozic could address epidemiology and moderate the panel, Dr. Michael Mayor or John Currier could cover what explant analysis has taught us about metal-metal tribology, and I am still willing to cover cobaltism and what we have learned from the Alaskan series of failed metal-metal arthroplasties.

Sincerely,

Stephen S. Tower, MD

On Feb 28, 2013, at 6:23 PM, Joshua Jacobs

wrote:

Dr. Tower,

Thank you for your communications expressing your concerns about the systemic effects of metal degradation products from joint replacement components. To study this issue, the orthopaedic device manufacturing industry needs to collaborate with researchers and laboratories that have expertise and clinicians who have access to patients with the devices. That is where I fit in – I oversee the metal ion analysis facility at Rush which is currently CLIA approved.

This is a topic that has been of great interest to me since 1980, when as a medical student I joined a team of researchers at Rush University Medical Center who had started pioneering research to characterize the systemic distribution of Ti, Al and V from porous titanium implants in subhuman primates. That study was one of the first papers I published (Woodman. J.L., Jacobs, J.J., Galante, J.O., and Urban, R.M.  Metal Ion Release from Titanium‑Based Prosthetic Segmental Replacements of Long Bones in Baboons:  A Long‑Term Study. J. Orthop. Res. 1: 421‑430, 1984).

I have continued to study the systemic distribution of metal following joint replacement. In the March 2013 issue of the JBJS the 10 year longitudinal results from our NIH-funded study on metal release from primary metal on polyethylene total hip replacements will be published: (Levine, B.R., Hsu, A.R., Skipor, A.K., Hallab, N.J., Paprosky, W.G., Galante, J.O. and Jacobs, J.J. Ten-Year Outcome of Serum Metal Ion Levels after Primary Total Hip Arthroplasty. A Concise Follow-up of a Previous Report. J Bone Jt Surg Am: 95 March, 2013).

Over the years, NIH, OREF and the orthopaedic implant industry have funded our laboratory to conduct systemic metal distribution studies. I have had industry funding from Wright Medical, Zimmer, Medtronic, Spinal Motion, Advanced Spine Technologies and Nuvasive to measure metal levels in patients with permanent metallic implants including hip and intervertebral disc replacement devices. It is important that the aforementioned companies collaborate with clinician investigators and provide support for research to study this issue.

During my service on the presidential line of the AAOS, I have not held any consulting relationships with the orthopaedic device industry. That was a requirement of the AAOS prior to my election to the presidential line. Despite the fact that my consulting stopped when I became second VP, ACCME rules required that I list financial relationships for the preceding 12 months. I realize this may cause some confusion when trying to interpret existing conflicts.

My current relationships with industry involve ongoing studies by our facility, to measure metal ion levels in the serum of patients with hip replacements and intervertebral disc replacements. This is important information in the characterization of the clinical performance of these devices. I personally receive no money from these research studies – the funding is used to pay for the labor and material costs of metal ion analysis and patient tracking.

As you know, I also list the fact that I have stock options in a company called Implant Protection. This company was the brainchild of Israeli scientists who were seeking a method of preventing metal and other debris from circulating into the synovial fluid and beyond. This is a laudable goal. These scientists reached out to me for background information on matters related to tribocorrosion of metal implants, an area of my research activity over the years. Since this company is a start up, they could not compensate me for time; rather stock options were offered. Currently the activities of this company are dormant and it is not clear that this situation will change.

Systemic effects of metal degradation products are an important consideration when evaluating patients with metal on metal bearings. I have consistently advocated that clinicians be aware of these effects and query their patients about their general health with particular emphasis on symptoms of cardiomyopathy, hypothyroidism, skin rash, neuropathy, and changes in hearing and vision. I have made this statement in many CME venues, including the Annual Meeting of the AAOS. For the March 2013 meeting, I intend to again make this point. I always try to present this information in the context of the best available evidence, which as you know is limited in this area. I know you have personally experienced systemic manifestations of elevated metal levels from your failed ASR and I always cite your published report in JBJS during my presentations. If you have additional scientific information from your own investigations of systemic effects that have not yet been published, please let me know so that I can update my presentations accordingly. I will be in Anchorage for the 2013 Alaska State Orthopaedic Society meeting on April 6th. If you are in attendance, I would be happy to meet with you for a more in-depth discussion.

We are always very concerned about the outcome of the procedures we do, including total hip replacement. It is our commitment to present the best scientific evidence available to inform our members and the public.

Thank you for your time and consideration.

Sincerely,

Joshua Jacobs, MD

1st VP AAOS

Professor and Chair

Department of Orthopaedic Surgery

Rush University Medical Center

On Sat, Feb 23, 2013 at 2:46 PM, Stephen S Tower  wrote:

Stephen Tower
Affiliated Professor UAA WWAMI School of Medicine
 

Dear Dr. DeHaven,

 I understand that President Tongue has deferred consideration of my concerns about surgeon-industry COI influencing the annual meeting CME content addressing the complications of Metal-Metal hip arthroplasty to you.

 I believe that the topic of surgeon-industry COI is critical and timely given the upcoming annual meeting of the AAOS. The attached PDF is a work in progress about surgeon-industry COI in the genesis of the metal-metal hip troubles. I do not believe that the degree to which a small group of industry consultant surgeons have controlled the literature, meeting content, and governance of the AAOS is well appreciated. Until this is appreciated I fear that there will be an avoidable continuance of the metal-metal troubles.

 The AAOS annual meeting has great influence among rank and file orthopedic surgeons and the upcoming one will be the third in which the complications of the metal-metal hips will likely be understated, to the potential determent of about a million patients.

 I made a concerted effort to assemble a symposium and an instructional course lecture on the local and systemic complications of chrome-cobalt metallosis for the 2013 annual meeting. I also submitted three papers for presentation at the scientific program. The faculty that I had recruited for the symposium and the ICL included:

Bernie Morrey- Professor Mayo Clinic.
Michael Mayor- Professor Dartmouth, founder Dartmouth Biomedical Engineering Center.
Kevin Bozic – Professor UCSF, expert on the epidemiology of hip replacement.
John Currier- research engineer at DBEC, he described that in vivo shortcomings of the metal-metal bearing couple.1
Stephen Graves – Head of the Aussie total joint registry that sounded the alarm about the high early revision rate of the ASR.2 3·     
Simona Catalani – Italian neuro-physiologist that has done recent experimental work on neuro-cobaltism.
Kristy Weber – John Hopkins Orthopedic oncologist, as a “neutral” moderator.
Stephen Tower – Arthroprosthetic Cobaltism.4 5

 The commercial conflicts of the hip program committee that rejected my five applications are delineated in the PDF, as are those of the five panelists chosen instead for the symposium the complications of the metal-metal hips. It is notable that 4 of 5 are consultants to arthroprosthetic companies with a stake in the fate of the metal-metal hips. Two are Biomet, one Zimmer, and one DePuy (the design surgeon of the ASR no less). The inclusion of Dr. Schmalzried to the panel seems equivalent to recruiting the captain of the Costa Concordia to give the seminar on safe cruise ship navigation.

 I understand that given my personnel experience that I have a biased perspective but I think I made a creditable effort to recruit a respected and relatively un-conflicted panel. As delineated in the PDF I have also made a concerted effort to express my concerns about surgeon-industry COI to the leadership of the AAOS. It is notable that at the time I started these efforts that two of the four were DePuy consultants, and one was a Zimmer consultant.

 Given my experience I am in an uncomfortable catbird seat of knowing the ways of the cat but being unable to communicate my knowledge to the other birds at risk. Because of my publications I am contacted frequently by patients likely in trouble with their metal-metal hips that have been dismissed by their surgeons. These surgeons have been reassured through the orthopedic literature and through the content at AAOS sponsored CME events that the local and systemic complications of chrome-cobalt metallosis are rare. We do know that if the complications chrome-cobalt metallosis are ignored eventual salvage surgery is more difficult and outcomes are compromised. The continued control of industry over the CME content at the AAOS annual meeting is likely to harm thousands.

 Given the degree to which industry influence dominates that leadership of the AAOS it seems unlikely the organization can correct this problem from within. The AAOS leadership has stated to me that such surgeon-industry relationships are “Kosher” because faculty must disclose potential COI, it is left to the audience to evaluate whether these commercial associations might influence presented educational content. However, the full disclosure forms are not readily available to the audience. The presenters flash up a crowded slide of their potential commercial conflicts and then state that these relationships are unrelated to the content of the presentation. I spent about 12 hours on the AAOS web site and on “Google Scholar” to unearth the potential commercial conflicts of the hip program committee and the panelists chosen for the metal-metal hip symposium. This is an effort not likely to be repeated by other AAOS member surgeons attending the meeting in Chicago.

 I am hopeful that you might review my concerns in an expedited fashion such that the symposium faculty addressing metal-metal hip complications might be changed to a balanced panel. Failure to do so has potential adverse impact on thousands of patients implanted with metal-metal hips.

Could you kindly inform me as to the temporal plan to review my concerns? Dr. Upsur Spencer is Alaska’s delegate to the board of councilors. I am hopeful that he might address these concerns at the Chicago meeting.

 Sincerely,

Stephen S. Tower

 1. Currier JH, McHugh DJ, Tower DR, Kennedy FE, Van Citters DW. Gouge features on metal-on-metal hip bearings can result from high stresses during rim contact. Tribology International 2012.

2. Graves SE. What is happening with hip replacement? Med J Aust 2011;194(12):620-1.

3. Graves SE, Rothwell A, Tucker K, Jacobs JJ, Sedrakyan A. A multinational assessment of metal-on-metal bearings in hip replacement. J Bone Joint Surg Am 2011;93 Suppl 3:43-7.

4. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.

5. Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am 2010;92(17):2847-51.

Stephen Tower
Orthopedic Surgeon
Affiliated Professor UAA WWAMI School of Medicine

Dear Dr. Jacobs,

Please consider this an open letter.

Your prompt reply to my concerns about Surgeon Industry Conflict of Interest(SICOI) and the Continuing Medical Education (CME) content at the upcoming annual meeting of the AAOS addressing the periprosthetic and systemic complications of chrome-cobalt metallosis is greatly appreciated.

I am aware of your many contributions over the past 25 years to the literature that supported the reintroduction of the metal-on-metal class of hips, the regulatory processes at the FDA that allowed for these devices to be implanted, and to the CME content of AAOS sponsored meetings and publications that persuaded American surgeons to select metal-metal hips over safer options in one-third of their patients over the course the past decade. You have consulted for Zimmer and Wright Medical; arthroprosthetic companies whose MoM liability exposure might exceed their gross capitalizations. You continue to hold stock options in Implant Protection, a company whose worth might soar with the awareness of the frequency and severity of the systemic complications of periprosthetic chrome-cobalt metallosis.

Your belief that a brief separation from industry derived income makes you an impartial authority on the complications for metal-metal hips now plaguing tens of thousands of American patients seems at best self deceptive. However, of the five surgeons selected by the hip program committee to address metal-metal hip complications in Chicago only Dr. Kwon is less conflicted that you are. Dr. Schmalzried, with whom you have collaborated, was paid by J&J 20 million dollars to design the ASR. The ASR was implanted in 92000 patients, has been withdraw from the market, and the ASR is likely to cost J&J of about 15 billion dollars. It would be unreasonable to expect that Dr. Schmalzried could reconcile the nature, severity, frequency, and impact of even the periprosthetic complications of chrome cobalt metallosis much less the systemic ones. When I last spoke with him he was still unaware of fifty years of case reports of cobalt poisoning from industrial exposure, the use of a cobalt beer additive, and the medicinal use of cobalt.

Dr. Lombardi and Dr. Fehring have likely been paid millions of dollars to promote Biomet’s arthroprosthetic products. Dr. Lombardi is the president of the Hip Society and is the chairman of the hip program committee that rejected my application for the Symposium, an Instructional Course Lecture, and three scientific papers addressing metal-metal hip complications. The majority of the members of the hip program committee are Biomet consultants and only several committee members have no declared SICOI. Biomet is another arthroprosthetic company whose metal-metal hip liabilities might exceed its capitalization.

Given that you have been a consultant to Zimmer for many years and that your focus of interest is metallurgic it is likely that you are, in part, are responsible for the design of the Durom. This case might interest you.

Thursday’s revision was a Durom implanted for 6 years, the patient had no symptoms at the hip. He was referred to me because his naturopathic leaning primary provider was aware of the potential for metal-metal hip related cobaltemia because my work is better recognized locally than nationally. His blood cobalt was in excess of 10 mcg/L on multiple occasions. His new neurologic and cardiac problems since his Durom implantation include impaired memory, weight loss, brain atrophy, urinary urgency, ataxia, progressive deafness, motor-sensory polyneuropathy, diastolic dysfunction and carditis. Although he had no symptoms at the hip he had a large mixed pseudo-tumor with moderate loss of hip capsule, severe proximal femoral lysis, and minor loss of hip abductors. Although the implants were optimally positioned the head shows a defined wear ellipsoid and multiple “hard stops” indicating material deformation from edge head contact. There was no bone ingrowth into the shell and most remarkably evidence of marked corrosion and fretting at the innermost taper junction of the head and neck.

Had this patient’s doctors followed present FDA recommendations for following patients implanted with metal-metal hips this gentleman’s cobaltemia, likely neurologic and cardiac cobaltism, and progressive periprosthetic tissue damage would likely have gone undiagnosed and might have progressed beyond remediation. I believe that you may have had a role in formulating the FDA’s rather tepid monitoring criteria.

This is just my most recent case. The number of metal-metal hips revised in our series is now at about 25, most have been notably cobaltemic, and about one-third appear to have been systemically toxic. In most instances we have metal levels, histopathology, and explant analysis. The case histories, the correlation of metal levels to systemic toxicity, the periprosthetic histopathology, and explant analysis were the subject of the three scientific papers that were rejected by Dr. Lombardi’s hip program committee. The detail and findings of the expanding Alaskan series is well beyond any I saw presented at last years annual meeting.

I appreciate your offer to present my research in Chicago. I would prefer to present it myself. Given that I am unlikely to be allowed near a podium I will forward the full updated series to you, piecemeal, one case report at a time followed by an analysis of the series as a whole. Since peer review of papers submitted for publication is done be the same industry entangled surgeons that determine what will be presented at meetings I will also web publish the information as I release it to you in “Blog” format. This appears to be my only means to limit the harm of neglected complications in hundreds of thousands of metal-metal hip implanted patients.

As you are aware I have been expressing concerns about the metal-metal hips to industry and to the Presidential Line of the AAOS since 2007 and to the FDA since early 2010. I now regret that I had not expressed my concerns more publicly. Given the barriers that I have experienced in presenting or publishing research counter to the interest of the arthroprosthetic industry it appears that the internet and the press might be the only means to convey relevant information to medical providers and patients.

Those that present CME content at meetings are allowed to influence the audience well beyond the merits of their research. That is how metal-metal hips were popularized. It would seem that the goal of the symposium on metal-metal hip complications in Chicago ought to be to educate the rank and file orthopedist not to further implant metal-metal hips and to recognize the early manifestations of chrome-cobalt metallosis so that the arthroplasty can be revised to one without chrome-cobalt components while the patient’s periprosthetic tissues are intact and before the patient experiences a decline in neurologic, cardiovascular, or endocrine function. If Dr. Schmalzried, Dr. Lombardi, and Dr. Fehring remain on the symposium panel those goals will not be optimally met and hundreds of thousands of patients might experience preventable harm. Surgeons that have promoted the metal-metal hips and been compensated millions for their efforts have every reason to be in a state of denial about the frequency and severity of the periprosthetic and systemic complications of chrome-cobalt metallosis.

Freeing three spots on the panel would allow for the addition of faculty that would further the idealized goals of having the symposium. Dr. Kevin Bozic could address epidemiology and moderate the panel, Dr. Michael Mayor or John Currier could cover what explant analysis has taught us about metal-metal tribology, and I am still willing to cover cobaltism and what we have learned from the Alaskan series of failed metal-metal arthroplasties.

Sincerely,

Stephen S. Tower, MD
On Feb 28, 2013, at 6:23 PM, Joshua Jacobs
 wrote:

Dr. Tower,

Thank you for your communications expressing your concerns about the systemic effects of metal degradation products from joint replacement components. To study this issue, the orthopaedic device manufacturing industry needs to collaborate with researchers and laboratories that have expertise and clinicians who have access to patients with the devices. That is where I fit in – I oversee the metal ion analysis facility at Rush which is currently CLIA approved.

This is a topic that has been of great interest to me since 1980, when as a medical student I joined a team of researchers at Rush University Medical Center who had started pioneering research to characterize the systemic distribution of Ti, Al and V from porous titanium implants in subhuman primates. That study was one of the first papers I published (Woodman. J.L., Jacobs, J.J., Galante, J.O., and Urban, R.M.  Metal Ion Release from Titanium‑Based Prosthetic Segmental Replacements of Long Bones in Baboons:  A Long‑Term Study. J. Orthop. Res. 1: 421‑430, 1984).

I have continued to study the systemic distribution of metal following joint replacement. In the March 2013 issue of the JBJS the 10 year longitudinal results from our NIH-funded study on metal release from primary metal on polyethylene total hip replacements will be published: (Levine, B.R., Hsu, A.R., Skipor, A.K., Hallab, N.J., Paprosky, W.G., Galante, J.O. and Jacobs, J.J. Ten-Year Outcome of Serum Metal Ion Levels after Primary Total Hip Arthroplasty. A Concise Follow-up of a Previous Report. J Bone Jt Surg Am: 95 March, 2013).

Over the years, NIH, OREF and the orthopaedic implant industry have funded our laboratory to conduct systemic metal distribution studies. I have had industry funding from Wright Medical, Zimmer, Medtronic, Spinal Motion, Advanced Spine Technologies and Nuvasive to measure metal levels in patients with permanent metallic implants including hip and intervertebral disc replacement devices. It is important that the aforementioned companies collaborate with clinician investigators and provide support for research to study this issue.

During my service on the presidential line of the AAOS, I have not held any consulting relationships with the orthopaedic device industry. That was a requirement of the AAOS prior to my election to the presidential line. Despite the fact that my consulting stopped when I became second VP, ACCME rules required that I list financial relationships for the preceding 12 months. I realize this may cause some confusion when trying to interpret existing conflicts.

My current relationships with industry involve ongoing studies by our facility, to measure metal ion levels in the serum of patients with hip replacements and intervertebral disc replacements. This is important information in the characterization of the clinical performance of these devices. I personally receive no money from these research studies – the funding is used to pay for the labor and material costs of metal ion analysis and patient tracking.

As you know, I also list the fact that I have stock options in a company called Implant Protection. This company was the brainchild of Israeli scientists who were seeking a method of preventing metal and other debris from circulating into the synovial fluid and beyond. This is a laudable goal. These scientists reached out to me for background information on matters related to tribocorrosion of metal implants, an area of my research activity over the years. Since this company is a start up, they could not compensate me for time; rather stock options were offered. Currently the activities of this company are dormant and it is not clear that this situation will change.

Systemic effects of metal degradation products are an important consideration when evaluating patients with metal on metal bearings. I have consistently advocated that clinicians be aware of these effects and query their patients about their general health with particular emphasis on symptoms of cardiomyopathy, hypothyroidism, skin rash, neuropathy, and changes in hearing and vision. I have made this statement in many CME venues, including the Annual Meeting of the AAOS. For the March 2013 meeting, I intend to again make this point. I always try to present this information in the context of the best available evidence, which as you know is limited in this area. I know you have personally experienced systemic manifestations of elevated metal levels from your failed ASR and I always cite your published report in JBJS during my presentations. If you have additional scientific information from your own investigations of systemic effects that have not yet been published, please let me know so that I can update my presentations accordingly. I will be in Anchorage for the 2013 Alaska State Orthopaedic Society meeting on April 6th. If you are in attendance, I would be happy to meet with you for a more in-depth discussion.

We are always very concerned about the outcome of the procedures we do, including total hip replacement. It is our commitment to present the best scientific evidence available to inform our members and the public.

Thank you for your time and consideration.

Sincerely,

Joshua Jacobs, MD

1st VP AAOS

Professor and Chair

Department of Orthopaedic Surgery

Rush University Medical Center

On Sat, Feb 23, 2013 at 2:46 PM, Stephen S Tower  wrote:

Stephen Tower
Orthopedic Surgeon
Affiliated Professor UAA WWAMI School of Medicine
 

Dear Dr. DeHaven,

 I understand that President Tongue has deferred consideration of my concerns about surgeon-industry COI influencing the annual meeting CME content addressing the complications of Metal-Metal hip arthroplasty to you.

 I believe that the topic of surgeon-industry COI is critical and timely given the upcoming annual meeting of the AAOS. The attached PDF is a work in progress about surgeon-industry COI in the genesis of the metal-metal hip troubles. I do not believe that the degree to which a small group of industry consultant surgeons have controlled the literature, meeting content, and governance of the AAOS is well appreciated. Until this is appreciated I fear that there will be an avoidable continuance of the metal-metal troubles.

 The AAOS annual meeting has great influence among rank and file orthopedic surgeons and the upcoming one will be the third in which the complications of the metal-metal hips will likely be understated, to the potential determent of about a million patients.

 I made a concerted effort to assemble a symposium and an instructional course lecture on the local and systemic complications of chrome-cobalt metallosis for the 2013 annual meeting. I also submitted three papers for presentation at the scientific program. The faculty that I had recruited for the symposium and the ICL included:

Bernie Morrey- Professor Mayo Clinic.
Michael Mayor- Professor Dartmouth, founder Dartmouth Biomedical Engineering Center.
Kevin Bozic – Professor UCSF, expert on the epidemiology of hip replacement.
John Currier- research engineer at DBEC, he described that in vivo shortcomings of the metal-metal bearing couple.1
Stephen Graves – Head of the Aussie total joint registry that sounded the alarm about the high early revision rate of the ASR.2 3·     
Simona Catalani – Italian neuro-physiologist that has done recent experimental work on neuro-cobaltism.
Kristy Weber – John Hopkins Orthopedic oncologist, as a “neutral” moderator.
Stephen Tower – Arthroprosthetic Cobaltism.4 5

 The commercial conflicts of the hip program committee that rejected my five applications are delineated in the PDF, as are those of the five panelists chosen instead for the symposium the complications of the metal-metal hips. It is notable that 4 of 5 are consultants to arthroprosthetic companies with a stake in the fate of the metal-metal hips. Two are Biomet, one Zimmer, and one DePuy (the design surgeon of the ASR no less). The inclusion of Dr. Schmalzried to the panel seems equivalent to recruiting the captain of the Costa Concordia to give the seminar on safe cruise ship navigation.

 I understand that given my personnel experience that I have a biased perspective but I think I made a creditable effort to recruit a respected and relatively un-conflicted panel. As delineated in the PDF I have also made a concerted effort to express my concerns about surgeon-industry COI to the leadership of the AAOS. It is notable that at the time I started these efforts that two of the four were DePuy consultants, and one was a Zimmer consultant.

 Given my experience I am in an uncomfortable catbird seat of knowing the ways of the cat but being unable to communicate my knowledge to the other birds at risk. Because of my publications I am contacted frequently by patients likely in trouble with their metal-metal hips that have been dismissed by their surgeons. These surgeons have been reassured through the orthopedic literature and through the content at AAOS sponsored CME events that the local and systemic complications of chrome-cobalt metallosis are rare. We do know that if the complications chrome-cobalt metallosis are ignored eventual salvage surgery is more difficult and outcomes are compromised. The continued control of industry over the CME content at the AAOS annual meeting is likely to harm thousands.

 Given the degree to which industry influence dominates that leadership of the AAOS it seems unlikely the organization can correct this problem from within. The AAOS leadership has stated to me that such surgeon-industry relationships are “Kosher” because faculty must disclose potential COI, it is left to the audience to evaluate whether these commercial associations might influence presented educational content. However, the full disclosure forms are not readily available to the audience. The presenters flash up a crowded slide of their potential commercial conflicts and then state that these relationships are unrelated to the content of the presentation. I spent about 12 hours on the AAOS web site and on “Google Scholar” to unearth the potential commercial conflicts of the hip program committee and the panelists chosen for the metal-metal hip symposium. This is an effort not likely to be repeated by other AAOS member surgeons attending the meeting in Chicago.

 I am hopeful that you might review my concerns in an expedited fashion such that the symposium faculty addressing metal-metal hip complications might be changed to a balanced panel. Failure to do so has potential adverse impact on thousands of patients implanted with metal-metal hips.

Could you kindly inform me as to the temporal plan to review my concerns? Dr. Upsur Spencer is Alaska’s delegate to the board of councilors. I am hopeful that he might address these concerns at the Chicago meeting.

 Sincerely,

Stephen S. Tower

 1. Currier JH, McHugh DJ, Tower DR, Kennedy FE, Van Citters DW. Gouge features on metal-on-metal hip bearings can result from high stresses during rim contact. Tribology International 2012.

2. Graves SE. What is happening with hip replacement? Med J Aust 2011;194(12):620-1.

3. Graves SE, Rothwell A, Tucker K, Jacobs JJ, Sedrakyan A. A multinational assessment of metal-on-metal bearings in hip replacement. J Bone Joint Surg Am 2011;93 Suppl 3:43-7.

4. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.

5. Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am 2010;92(17):2847-51.

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