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Sunday, January 6, 2013

Dear Senator Begich,

I am very appreciative of your personal reply to my concerns about the regulatory malfeasance at the FDA that led to the Metal-on-Metal hip replacement debacle, has allowed most of these devices to remain on the market, and has left medical providers without any guidelines on how to monitor a half million Americans for the periprosthetic and systemic complications of chrome-cobalt metallosis.

Due to personnel, professional, and research interest I have become an advocate for the approximate 400 Alaskans and half million Americans implanted with this benighted technology. I hope your medical staffer will brief you on this problem and its cost. Briefly, somewhere between 25% and 50% of the patients implanted with this class of hip replacement will require a high risk revision operation within ten years of their primary operation. These repeat surgeries are necessary because wear products of the metal bearing surfaces of these implants can kill the tissues about the hip. Cobalt and chromium generated at the hip are also systemically circulated and can damage the heart, brain, peripheral nerves, and thyroid gland. Bloomberg has estimated the liability of a single prematurely failed hip replacement to be $250,000. The cost to society of this entrepreneurial, professional, and regulatory misadventure in the United States will fall between 30 and 60 billion dollars (if 25 to 50 percent of the 500,000 Americans implanted with this class of hip require premature revision surgery over the next 10 years).

Given that cost effective and safe medical care in the United States is of acute interest I hope that this problem might attract the ongoing interest of your office. I understand that the demands on your attention are many but this instance of regulatory incompetence by the FDA is significant to Alaska and the United States and is emblematic of a myriad of problems within the American health care system. Unless the genesis of such problems is studied and understood efforts at health care reform will fail.

At the Anchorage Fracture and Orthopedic Clinic we have prematurely revised the Metal-Metal hips of 25 patients. These Alaskans are incensed that the FDA allowed this flawed technology to be implanted, has been slow to remove these devices from the market, and has not given medical providers guidance on how to monitor metal-metal hip implantees for complications. These patients’ faith in the FDA and in federal government has been severely undermined. Perhaps no regulation is preferable to corrupt and expensive regulation that is responsible only to industry. I would like to reassure these patients that your office has some interest in their problems. Your knowledge of this example of a flawed regulatory process could assist in effective American health care reform. Such reform, properly done, would improve care and save billions of dollars.

The genesis of the delay in the recognition of the complications from the Metal-Metal hips is not one of science but one of who is allowed to present science to the FDA. The FDA is unwilling to accept input from any “experts” other than those forwarded by industry. I submitted the first recognized cases of neurologic and cardiac cobalt poisoning from this class of hip replacement in early 2010, the peer review process delayed publication of this report until December of 2010. Realizing the epidemiological ramifications of my experience I involved our state epidemiologist and through his efforts the CDC. The FDA prohibited the CDC from mentioning cobalt poisoning by hip replacement in its national publications in the spring of 2010. This stimulated my appeal to your office for assistance in the summer of 2010. With your help I was able to connect to Dr. Aaron Yustein at the FDA who explained to me

‘.Dr. Tower, you do not understand, when we believe there is a problem with a medical device we sit down with industry to determine if a problem exists, you do not work for industry, you have no standing with the FDA.’

I first observed a hip replacement in 1979 as a first year WWAMI student in Fairbanks. As a General Medical Officer at the Alaska Native Medical Center I assisted on about a thousand major orthopedic operations from 1984 through 1986. As an orthopedic resident at Oregon Health Sciences University I assisted with and performed hundreds of primary and revision hip replacements. Failure mechanisms of hip replacements were the focus of my research at OHSU from 1990 through 1992. My work earned the Neufeld prize of the Western Orthopedic Association in 1992, was published, and remains frequently cited as a resource paper on the treatment of fractures that occur about hip replacements.1 2 In 1992 I joined the Anchorage Fracture and Orthopedic Clinic and began a practice focused on complex hip replacement and revision hip replacement surgery. Then I also started to collaborate with the Dartmouth Biomedical Engineering Center (DBEC) on the analysis of the failed hips that I explanted. About ten years ago major modifications were made in the plastic used for the socket in hip replacements. I observed an under appreciated failure mechanism of these new plastic sockets and with DBEC published a report of these failures.3 This work contributed to the design of contemporary hip socket liners.

I resented being brushed off by the FDA in the summer of 2010. I had another unique qualification to assist them in understanding the local and systemic complications of the Metal-Metal hips: I had experienced both. In 2006 I was implanted with a DePuy ASR hip. Within a year I was surprised to note increasing hip pain. I thought that I might be experiencing abnormal wear of my ASR. Severe tissue damage from chrome-cobalt debris (metallosis) from the wear of Metal-Metal hip bearing surfaces was reported in 1975. These patients were also found to have notably high levels of cobalt in their blood and organs. The investigators cautioned against the use of Metal-Metal hips and noted that damage to the heart was a known complication of elevated blood cobalt.4 In 2007 I was not aware of Dr. Jones’ work but measurement of blood cobalt and chromium levels was being used as a research tool to study the wear of the new Metal-Metal hips.5 I had mine measured, my blood cobalt level was 200 times normal and 40 times the Biologic Exposure Threshold (BET).6 7

The BET is used in industry to monitor workers for excessive cobalt exposure. This was curious, my levels were 20 to 40 times those reported in studies of patients with contemporary Metal-Metal hips. Such elevated levels indicated that my hip was wearing at an excessive rate, I thought this might explain my pain. My surgeon and I sought opinions from DePuy design surgeons and engineers. We were reassured that chrome cobalt metallosis was not toxic either at the hip or systemically. DePuy claimed they had not received any reports of similar concerns. As the founder of the annual Alaskan orthopedic meeting and president of the Anchorage Orthopedic Society I was well connected to leading American research hip surgeons.

Most prominent American research hip surgeons collaborate with industry and they are also active in the governance of the American Academy of Orthopedic Surgeons (AAOS) and are on the editorial boards of the orthopedic journals. It seemed unlikely that I was experiencing an unreported complication of a commonly used implant but my prior research on the failed plastic sockets suggested that this might be a possibility. In the summer of 2007 I did not appreciate the degree to which commercial conflict of interest might be influencing the CME content of orthopedic meetings and the content of the orthopedic literature. Dr. Jones’ seminal paper in 1975 on the complications of Metal-Metal hips and the potential for systemic complications was almost never cited in the hundreds of publications between 1990 and 2006 that supported the reintroduction of the Metal-Metal hip.

In the fall of 2007 I became neurologically ill and my cobalt levels had climbed to 120 times the BET. I repeated my inquiries to DePuy, ‘.No worries Dr. Tower, cobalt is harmless.’ I was not well enough to disagree. My illness allowed partial productivity but all my faculties were occupied by personal and professional survival. The hip pain progressed over the next two years and the hip would grate or squeak with each step. I developed progressive problems with memory, cognition, mood, sight, hearing, and had progressive breathlessness with exercise. I had a theory that my medical issues might be related to my high cobalt levels but given the reassurances from leading hip surgeons and DePuy that cobalt poisoning was nonexistent I dismissed my theory as being either paranoid or delusional.

In November of 2009 my ASR was revised, the pain at the hip had become unremitting, I had been forced to curtail physical fitness activities, and I required pain medications to sleep. Before my surgery I had a cardiac work-up, I was found to have stiffening of the heart (cardiomyopathy) that explained my exertional breathlessness. The same test just before my ASR had shown a normal heart function.

My theory of causality resurfaced after my revision operation. Over the month after surgery my blood cobalt levels plunged and my mind and mood improved, a year after the ASR was removed my heart returned to normal function. My revision surgeon had found an untended crankcase of metallic sludge around the ASR. The ligaments about the hip were mush. Although my hip pain improved markedly after the revision operation the loss of these ligaments has been problematic, my new hip dislocates frequently, there is little left to hold the ball in the socket.

Within months of my revision surgery one of my patients with a Metal-Metal hip came to revision surgery. His problems were similar to mine but were fortunately not as severe. His blood cobalt levels were 20 times the BET. His problems resolved and his blood cobalt levels fell after the ASR was removed. My experience and that of my patient were the subject of my first publications on arthroprosthetic cobaltism.8 9 Organized orthopedics received these papers with measured skepticism, if cobalt poisoning by hip replacement existed certainly it would have been previously reported.10

The surgeons of my clinic, the Anchorage Fracture and Orthopedic Clinic, have now revised about 25 patients with prematurely failed Metal-Metal hips. Two-thirds of these patients are have notably high blood cobalt levels and a third have developed new medical problems consistent with cobalt poisoning (cobaltism). These patients are angry and bewildered by the regulatory incompetence or corruption that lead to their new medical problems and their high risk repeat operations. I would like to be able to reassure them that a member of the Alaskan delegation to Congress has some interest in their concerns.

This past summer I volunteered for the FDA’s expert panel on Metal-Metal hip problems, I was willing to fly to Washington on my own dime. Dr. William Maisel informed me that I was not a candidate for the panel because panel members needed to be nominated by industry or by the AAOS. At the time of my publication on arthroprosthetic cobaltism three of four members of the Presidential Line of the AAOS were consultants to arthroprosthetic companies marketing Metal-Metal hips. One of the Vice Presidents of the AAOS wrote the skeptical commissioned commentary on my case report.10 The AAOS and industry are inextricably entwined; medical device regulation is done by industry by the FDA’s proxy.

The FDA has yet to provide guidelines to medical providers on how to monitor patients implanted with Metal-Metal hips for problems at the hip, the brain, the peripheral nerves, the heart, or the thyroid gland. Most of these devices remain on the market and continue to be implanted. The British equivalent of the FDA, the MHRA, has been proactive and has issued extensive monitoring guidelines. It is a moral imperative that I share my pre-published research with industry and regulators. Dr. Susan Ludgate is the chief at the MHRA; every communication I have sent to her has generated a personal interested reply. Dr. Maisel is the subsection chief of the FDA in charge of medical devices; he rarely acknowledges my communications.

I organized a panel of professors to address metal-metal hip complications a this years annual meeting of the AAOS. The program committee rejected my application in the favor of a panel composed of four industry consultant surgeons. The head of the program committee selected himself to the panel and two-thirds of the program committee are industry consultants. I have been reassured by the President of the AAOS that conflict of interest does not influence in the CME content at AAOS hosted meetings.

The Metal-Metal hip troubles are emblematic of the problems that can occur when entrepreneurial medicine is practiced without effective regulatory oversight. It also speaks to the cost inefficiency of American medicine. Both topics ought to be of acute interest to Congress given their implications to health care reform. The delayed response of organized orthopedics and the FDA to the epidemic of metal-metal hip complications underscores the danger of orthopedic professional, scientific, and educational processes that are financed by and therefore controlled by industry.

The Metal-Metal hip debacle is an Alaskan issue and a national issue. Hundreds of Alaskans and about a half million Americans are potentially adversely affected and billions of dollars of health resource have been squandered. I understand by necessity that members of Congress specialize in specific issues and health care reform and regulation might not be your particular interest. If your office does not have resource or interest in this issue I would greatly appreciate if you could connect me with a congressperson with interest in this area.

Anchorage Fracture and Orthopedic Clinic and Providence Alaska Medical Center are committed to tracking down the patients at risk for metallosis related hip and systemic complications. Such an effort could be foundational to establishing a state wide total joint registry; if we succeed the Alaska will have the first regional registry in the United States. My experience with the complications of new Metal-Metal and Metal-Plastic hip technology suggests that a small comprehensive regional registry that investigates premature arthroplasty failures and employs explant analysis can improve outcomes and save billions of health resource dollars for a pittance.

I am in the process of recruiting WWAMI and UAA resources to further the study of metallosis related arthroplasty complications and the impact of conflict of interest in the genesis of the Metal-Metal hip troubles. I hope that this effort will be foundational to the establishment of an Alaskan Total Joint registry that will allow for ongoing study of arthroplasty effectiveness, complications, and cost. Such an effort will benefit Alaska by improving the outcomes of total joint replacement and will also demonstrate that WWAMI and UAA have health care research capability.

I believe what we have learned in Alaska has national health policy implications. It is critical that Congress understands how medical device regulatory processes allowed the Metal-Metal hip devices to be commonly implanted, why most of these devices to remain on the market, and why guidelines for monitoring patients implanted with Metal-Metal hips for metallosis related complications have not yet been issued by the FDA.

I would appreciate your assistance and that of your staffers in opening a line of communication with the FDA. If the FDA continues to only consider “science” provided by industry consultant surgeons the Metal-Metal hip problems will continue and similar problems with other devices will emerge.

Again, I appreciate your personal attention regarding this issue, and I understand there are limits to your time. I would be most appreciative if one of your staffers would take the point on this problem and acknowledge that communications such as this are received and considered.

Sincerely,
Stephen S. Tower
Orthopedic Surgeon
(907) 947-1012

  1. Beals RK, Tower SS. Periprosthetic fractures of the femur: an analysis of 93 fractures. Clin Orthop Relat Res 1996;327:238.
  2. Tower SS, Beals RK. Fractures of the femur after hip replacement: the Oregon experience. Orthop Clin North Am 1999;30(2):235-47.
  3. Tower SS, Currier JH, Currier BH, Lyford KA, Van Citters DW, Mayor MB. Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty. J Bone Joint Surg Am 2007;89(10):2212-7.
  4. Jones DA, Lucas HK, O’Driscoll M, Price CH, Wibberley B. Cobalt toxicity after McKee hip arthroplasty. J Bone Joint Surg Br 1975;57(3):289-96.
  5. Skipor AK, Campbell PA, Patterson LM, Anstutz HC, Schmalzried TP, Jacobs JJ. Serum and urine metal levels in patients with metal-on-metal surface arthroplasty. J Mater Sci Mater Med 2002;13(12):1227-34.
  6. Alimonti A, Bocca B, Mannella E, Petrucci F, Zennaro F, Cotichini R, et al. Assessment of reference values for selected elements in a healthy urban population. Ann Ist Super Sanità;41(2):181-87
  7. Hygienists ACoGI. 2000TLVs and BEIsthreshold limit valuesfor chemical substance and physical agents and biological exposure indices. 2000.
  8. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.
  9. 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.
  10. Jacobs JJ. Commentary on an article by Stephen S. Tower, MD: “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):e35.
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