Background:

The FDA recently announced two days of hearings of the Immunology Advisory Panel relating to the auto immune and inflammatory responses to the metals in implants.  They do not mention toxicity, but do ask what other areas they should look into to expand their understanding.  Trust them or not, this is an opportunity to raise our voice and be heard.  The fact that this meetings are being held is in direct response to patient input regarding strengthening the 510(k).  We would wish for that pathway to go away, but given the reality that this is highly unlikely, we want to influence new standards as much as possible.  The link below will take you to the FDA announcement, which contains all the information and links about dates, times, place, webcast viewing, and making public comments.  You will note that the meetings are exploring 4-5 topics.  Comments should be directed at those questions.

Secondly, Dr. Tower and Dr. Bridges have applied to the FDA to be on this panel, and they are being denied.  The attached file below is an open letter from these two men, for which we have permission to use in our own efforts contacting elected officials and FDA to put pressure on them to seat both Tower and Bridges on the panel.  This is the second time Tower has applied to be on a special panel related to hips (June 2012) and has been shut out.  It looks and smells like collusion with industry.  Whatever the reasoning behind this denial, it is in the best interest of the public to change course and allow both doctors to be part of the panel.  They have unique and valuable research about which the panel needs to learn.

For those of you in the USA please call, write or make appointments with your Congresspersons and Senators – even at their home offices in your area.  Let’s work together to call out the FDA in this matter.

[https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-13-14-2019-immunology-devices-panel-medical-devices-advisory-committee-meeting-announcement](https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-13-14-2019-immunology-devices-panel-medical-devices-advisory-committee-meeting-announcement)

Open Letter

10/5/19 4:35 AM

Dear Senator Murkowski,

We are grateful for the opportunity to meet with Ms. Ramponi on Monday to discuss our experiences as patients, physicians, and researchers into the periprosthetic, neurologic, and cardiac complications of internal cobalt exposure from wear or corrosion of Cobalt-Chrome alloy joint replacement parts. 10-15 million Americans are implanted with such devices and based on our study of Alaskan patients likely 7 million Americans have blood or urine cobalt levels that would not be acceptable from an industrial hygiene standpoint.

With the assistance of the Alaska State Epidemiology, UAA, and Alaska’s Medical School, Bridges & Tower & Cho are the spear point for defining the scope of these common complications.1-9 Despite a decade of peer-reviewed publications defining Adverse Reaction to Metallic Debris (ARMD) at the device and the deleterious effect of systemic circulation of cobalt to the brain, heart, and peripheral nerves the FDA repeatedly fails to accept that Tower & Bridges have standing to participate on the FDA’s Expert Panels regarding Medical Device complications, design, and regulation. The FDA has explained to Dr. Tower on multiple occasions that he is ineligible for participation on such panels because he has not been nominated by industry or by his professional organization, the American Academy of Orthopedic Surgeons (AAOS). For these stated reasons he was excluded from the 2012 FDA expert panel meeting on the complications of Metal-on-Metal Hips despite being the only American with peer-reviewed publications on the neurologic and cardiac cobalt complications of modern Metal-on-Metal hips.1,5-9 Before his personal experience with ARMD and Cobaltism as a patient, Tower had published on other mechanisms of premature failure of joint replacement devices,10-12 biomechanics,13 and the epidemiology of medical and orthopedic disorders of Alaskans.14,15

Realizing that the FDA’s pre-market and post-market medical device regulatory processes were hopelessly corrupted by unbalanced industry-influence based on his failed 2012 efforts to participate in the FDA’s expert panel on Metal-on-Metal hip complications  Tower and Alaska Epidemiology twice requested that the CDC investigate cobalt poisoning by joint replacement. In both instances the FDA obstructed a CDC investigation.16-19

Bridges & Tower began break-through brain imagining of patients with elevated blood and urine cobalt levels from their excessively wearing or corroding joint parts in 2014.20-24 This work promises to revolutionize the diagnosis and treatment of millions of Americans experiencing cognitive decline as a complication of systemic cobalt exposure from their implanted Cobalt-Chrome hip, knee, or shoulder parts. To date we have imaged nearly 80 cobalt-poisoned patients and have discovered a pathognomonic pattern of brain hypometabolism (P0526 & P0547). This gives us a critical tool to diagnose Arthroprosthetic Cobalt Encephalopathy (ACE) and monitor the progression of this malady and its response to treatment. Tower & Bridges’ experience as researchers and whistleblowers is featured in Netflix’s documentary THE BLEEDING EDGE.25

We believe that preventable harm to millions might be mitigated if Senator Murkowski would consider expediting the appointment of Tower & Bridges to the FDA’s expert panel addressing the immune complications of metallic medical devices that is meeting in DC November 13-14. We also believe that she should instigate an investigation of the FDA’s regulatory malfeasance that has lead to preventable medical harm to 7 million Americans. Given that expeditious reform of the FDA is unlikely it is also critical that Senator Murkowski consider sponsoring the Medical Device Safety Act.

Respectfully,

Stephen S. Tower, MD Orthopedic Surgeon, Affiliated Professor UAA-AMS, survivor ARMD and Cobaltism from J&J Hip stephentower@mac.com Robert  L.  Bridges,  MD  Board  Certified  Nuclear  Medicine  Physician  and  Diagnostic  Radiologist  rbridgesmd@hotmail.com Christina Cho, BA Research Assistant Tower Orthopedic Clinic christinachoak@gmail.com

1. Epidemiology A. Cobalt Toxicity in Two Hip Replacement Patients. State of Alaska Epidemiology Bulletin 2010.
2. Woelber E, Van Citters DW, Steck T, Glass GA, Tower S. Explant Analysis from a Patient Exhibiting Rapid Acceleration of Parkinson Disease Symptoms and Hypercobaltemia Following Metal-on-Metal Total Hip Arthroplasty: A Case Report. JBJS Case Connect 2016;6:e45.
3. Gessner BD, Steck T, Woelber E, Tower SS. A Systematic Review of Systemic Cobaltism After Wear or Corrosion of Chrome-Cobalt Hip Implants. J Patient Saf
4. Sotos JG, Tower SS. Systemic disease after hip replacement: aeromedical implications of arthroprosthetic cobaltism. Aviation, space, and environmental medicine 2013;84:242-5.
5. 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
6. Estey MP, Diamandis EP, Van Der Straeten C, Tower SS, Hart AJ, Moyer TP. Cobalt and Chromium Measurement in Patients with Metal Hip Prostheses. Clinical chemistry
7. Tower SS. Arthroprosthetic cobaltism associated with metal on metal hip implants. Bmj 2012;344:e430.
8. 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;92:2847-51.
9. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.
10. 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;89:2212-7.
11. Tower SS, Beals RK. Fractures of the femur after hip replacement: the Oregon experience. Orthop Clin North Am 1999;30:235-47.
12. Beals RK, Tower SS. Periprosthetic fractures of the femur. An analysis of 93 fractures. Clin Orthop Relat Res 1996:238-46.
13. Tower SS, Beals RK, Duwelius PJ. Resonant frequency analysis of the tibia as a measure of fracture healing. Journal of orthopaedic trauma 1993;7:552-7.
14. Tower SS, Simonsen BL, Propst MT. Snowmachine related mortality and morbidity in Alaska: a comparison with non-motorized winter sport. Alaska Med 2000;42:94-5,
15. Tower SS, Pratt WB. Spondylolysis and associated spondylolisthesis in Eskimo and Athabascan populations. Clin Orthop Relat Res 1990:171-5.
16. Tower S. Hip Metallosis and Corrosion-A Million Harmed Due to FDA Inaction. J Patient Saf
17. Kelly T, Bauer S, Tower S. Power, Credibility and Expertise in a Colonized Medical Discourse.
18. Kavanagh KT, Tower SS, Saman DM. A Perspective on the Principles of Integrity in Infectious Disease Research. J Patient Saf 2016;12:57-62.
19. 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:e35.
20. Jiang J, Sun Y, Zhou H, et al. Study of the Influence of Age in 18F-FDG PET Images Using a Data-Driven Approach and Its Evaluation in Alzheimer’s Disease. Contrast media & molecular imaging 2018;2018.
21. Nasrallah IM, Wolk DA. Multimodality imaging of Alzheimer disease and other neurodegenerative dementias. J Nucl Med 2014;55:2003-11.
22. Hsieh TC, Wu YC, Yen KY, Chen SW, Kao CH. Early changes in brain FDG metabolism during anticancer therapy in patients with pharyngeal cancer. J Neuroimaging 2014;24:266-72.
23. Herholz K, Westwood S, Haense C, Dunn G. Evaluation of a calibrated 18F-FDG PET score as a biomarker for progression in Alzheimer disease and mild cognitive impairment. Journal of Nuclear Medicine 2011;52:1218-26.
24. Mosconi L, Tsui WH, Pupi A, et al. 18F-FDG PET database of longitudinally confirmed healthy elderly individuals improves detection of mild cognitive impairment and Alzheimer’s disease. Journal of Nuclear Medicine 2007;48:1129-34.
25. Pendyal A, Ross JS. The Bleeding Edge: Documenting Innovation and Injury in the Medical Device Industry. Jama 2019;322:190-2.

PDF of letter plus attachments: Murkowski 05102020 s patients