The Danger Within Us

by Jeanne Lenzer

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  68. Mirsattari SM, Gofton TE, Chong DJ. Misdiagnosis of epileptic seizures as manifestations of psychiatric illnesses. Can J Neurol Sci. May, 2011;38(3):487–493.

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  77. Fegan D. VNS: A Cure All??? 2011. http://www.vnsmessageboard.com/index.php?topic=3933.0;all.

  78. Epilepsy Foundation. Atonic and tonic seizures. http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/first-aid/atonic-and-tonic-seizures.

  79. Interview with Larry Johnson (in person), January 11, 2014.

  80. Nickels KC, Grossardt BR, Wirrell EC. Epilepsy-related mortality is low in children: a 30 year population-based study in Olmsted County, MN. Epilepsia. 2012;53(12):2164–2171. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3766953/.

  81. Tomson T, Walczak T, Sillanpaa M, Sander JW. Sudden unexpected death in epilepsy: a review of incidence and risk factors. Epilepsia. 2005;46 Suppl 11:54–61. http://www.ncbi.nlm.nih.gov/pubmed/16393182.

  82. Spencer DC. SUDEP: sudden unexpected death in epilepsy on placebo? Epilepsy Currents. 2012;12(2):51–52. http://www.ncbi.nlm.nih.gov/pubmed/22473539.

  83. Velagapudi P, Turagam M, Laurence T, Kocheril A. Cardiac arrhythmias and sudden unexpected death in epilepsy (SUDEP). Pacing Clin Electrophysiol. 2012;35(3):363–370. http://www.ncbi.nlm.nih.gov/pubmed/22126214.

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  85. Preskitt JT. Health care reimbursement: Clemens to Clinton. Baylor University Medical Center Proceedings. 2008;21(1):40–44. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2190551/.

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  88. Stevens RA. Health eare in the early 1960s. Health Care Financ Rev. 1996;18(2):11–22. http://www.ssa.gov/history/pdf/HealthCareEarly1960s.pdf.

  89. Medicine: doctors’ pay. Time 1951. http://content.time.com/time/magazine/article/0,9171,815193,00.html.

  90. Brownlee S. Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer. New York: Bloomsbury USA; 2007.

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  93. Herman B. 12 Statistics on CT Scanner Costs. Becker's Hospital Review 2012. http://www.beckershospitalreview.com/hospital-key-specialties/12-statistics-on-ct-scanner-costs.html.

  94. Brody H. Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Lanham, MD: Rowman & Littlefield; 2007.

  95. National health expenditures data 1960–2014. Centers for Medicare and Medicaid Services. 2014. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/NHEGDP14.zip.

  96. Government Accountability Office. Medical Device Companies: Trends in Reported Net Sales and Profits Before and After Implementation of the Patient Protection and Affordable Care Act. 6/30/2015. http://www.gao.gov/assets/680/671094.pdf.

  97. Meier B. Costs surge for medical devices, but benefits are opaque. New York Times 2009. http://www.nytimes.com/2009/11/05/business/05device.html?_r=0.

  98. Swirsky L. Health policy brief: medical device manufacturer profits. Consumers Union. 2013. http://consumersunion.org/research/health-policy-brief-medical-device-manufacturer-profits/.

  99. US Food and Drug Administration. UDI basics. 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm.

  100. Lenzer J, Brownlee S. Why the FDA can’t protect the public. BMJ. 2010;341:c4753. http://www.bmj.com/content/341/bmj.c4753.long.

  101. Daniel G, Colvin H, Khaterzai S, McClellan M, Pranav A. Strengthening Patient Care: Building an Effective National Medical Device Surveillance System. Washington, DC: Brookings Institution; 2015. http://www.brookings.edu/research/papers/2015/02/23-medical-device-postmarket-surveillance-roadmap-daniel.

  102. Chelimsky E. Medical Devices: Early Warning of Problems Is Hampered by Severe Underreporting. Government Accountability Office.1986. http://www.gao.gov/products/PEMD-87-1.

  103. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171(11):1006–1011. http://dx.doi.org/10.1001/archinternmed.2011.30.

  104. Gholipour B. New implant no longer dangerous in MRI. LiveScience 2013. http://www.livescience.com/38926-new-mri-safe-implant.html.

  105. 3-Tesla MR safety information for implants and devices. MRISafety.com. 2017. http://www.mrisafety.com/SafetyInfov.asp?SafetyInfoID=227.

  106. Hoshaw L. Millions of Americans use medical devices that may be vulnerable to hacking. KQED News. 2015. https://ww2.kqed.org/futureofyou/2015/08/03/millions-of-americans-use-medical-devices-that-are-vulnerable-to-hacking/.

  107. Cleary D. Could a wireless pacemaker let hackers take control of your life? Science 2015. http://www.sciencemag.org/news/2015/02/could-wireless-pacemaker-let-hackers-take-control-your-heart.

  108. Kirk J. Pacemaker hack can deliver deadly 830-volt jolt. ComputerWorld 2012. http://www.computerworld.com/article/2492453/malware-vulnerabilities/pacemaker-hack-can-deliver-deadly-830-volt-jolt.html.

  109. Hacker dies days before he was to reveal how to remotely kill pacemaker patients. RT. 2013. https://www.rt.com/usa/hacker-pacemaker-barnaby-jack-639/.

  110. Newman L. Medical devices are the next security nightmare. Wired 2017. https://www.wired.com/2017/03/medical-devices-next-security-nightmare/.

  111. Memorandum of Understanding Between the Centers for Medicare and Medicaid Services Coverage and Analysis Group and the U.S. Food and Drug Administration Center for Devices and Radiological Health Regarding Categorization of Investigational Devices. Mou 225-16-024. 2016. http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm477091.htm.

  112. Talbot D. Computer viruses are “rampant” on medical devices in hospitals. MIT Technology Review. Oct 17, 2012. https://www.technol
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  113. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122(16):1553–1561. https://www.ncbi.nlm.nih.gov/pubmed/20921437.

  114. Letter from Juan E. Bahamon, MD, to Dennis Fegan dated Dec 12, 2006.

  115. Braunwald E, Epstein SE, Glick G, Wechsler AS, Braunwald NS. Relief of angina pectoris by electrical stimulation of the carotid-sinus nerves. N Engl J Med. 1967;277(24):1278–1283. http://www.nejm.org/doi/full/10.1056/NEJM196712142772402.

  116. Braunwald E, Vatner SF, Braunwald NS, Sobel BE. Carotid sinus nerve stimulation in the treatment of angina pectoris and supraventricular tachycardia. West J Med. 1970;112(3):41–50.

  117. Langreth R. Rewiring the brain. Forbes 2001. http://www.forbes.com/forbes/2001/0305/160.html.

  118. Infitialis. Under surveillance: blowing the whistle on Cyberonics. StreetSweeper 2013. http://www.thestreetsweeper.org/undersurveillance/Blowing_the_Whistle_on_Cyberonics.

  119. Medical Device and Diagostic Industry. The two-year turnaround. 2008. http://www.mddionline.com/article/two-year-turnaround.

  120. Mabin DC. BMJ should declare its own conflict of interest. BMJ. 1995;311(7009):878–879. PM:0007580526.

  121. Phone interview with Robert “Skip” Cummins, April 2, 2015.

  122. Nocera J. A C.E.O. who carries a big stick. New York Times 2005. http://query.nytimes.com/gst/fullpage.html?res=9407EFDD1F30F93BA35753C1A9639C8B63=.

  123. Hines JZ, Lurie P, Yu E, Wolfe S. Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med. 2010;7(7):e1000280. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2903853/.

  124. Chan PS, Patel MR, Klein LW, et al. Appropriateness of percutaneous coronary intervention. JAMA. 2011;306(1):53–61. http://www.ncbi.nlm.nih.gov/pubmed/21730241.

  125. Rothberg MB, Scherer L, Kashef M, et al. The effect of information presentation on beliefs about the benefits of elective percutaneous coronary intervention. JAMA Intern Med. 2014;174(10):1623–1629. http://dx.doi.org/10.1001/jamainternmed.2014.3331.

  126. Rothberg MB, Sivalingam SK, Ashraf J, et al. Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable coronary disease. Ann Intern Med. 2010;153(5):307–313. http://www.ncbi.nlm.nih.gov/pubmed/20820040.

  127. Bradley SM, Spertus JA, Kennedy KF, et al. Patient selection for diagnostic coronary angiography and hospital-level percutaneous coronary intervention appropriateness: insights from the national cardiovascular data registry. JAMA Intern Med. 2014;174(10):1630–1639. http://dx.doi.org/10.1001/jamainternmed.2014.3904.

  128. Brown DL, Redberg RF. Continuing use of prophylactic percutaneous coronary intervention in patients with stable coronary artery disease despite evidence of no benefit: déjà vu all over again. JAMA Intern Med. May 1, 2016;176(5):597–598. http://www.ncbi.nlm.nih.gov/pubmed/27019878.

  129. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary interventions for stable coronary artery disease. Arch Intern Med. 2007;167(15):1604–1609.

  130. Stergiopoulos K, Brown DL. Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials. Arch Intern Med. 2012;172(4):312–319. http://www.ncbi.nlm.nih.gov/pubmed/22371919.

  131. Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503–1516. http://www.nejm.org/doi/full/10.1056/NEJMoa070829.

  132. Interview with Rita Redberg (phone and e-mail), May 7, 2017.

  133. Tenth meeting of FDA’s Center for Devices and Radiological Health Neurological Devices Panel. 1997. www.fda.gov/ohrms/dockets/ac/97/transcpt/3299t1.pdf.

  134. Jones D. Company news: St. Jude Medical to buy maker of neurology devices. New York Times 1996. http://www.nytimes.com/1996/04/09/business/company-news-st-jude-medical-to-buy-maker-of-neurology-devices.html.

  135. Handforth A, DeGiorgio CM, Schachter SC, et al. Vagus nerve stimulation therapy for partial-onset seizures: a randomized active-control trial. Neurology. 1998;51(1):48–55. http://www.neurology.org/cgi/content/abstract/51/1/48.

  136. Lurie P, Stine N, Wolfe S (Public Citizen). Petition to reverse the FDA’s prior approval of the vagus nerve stimulation (VNS) device for the management of treatment-resistant depression. 2006. http://www.fda.gov/ohrms/dockets/dockets/06p0370/06p-0370-cp00001-vol1.pdf.

  137. Malisow C. Exposed nerve. Houston Press 2005. http://www.houstonpress.com/2005-04-07/news/exposed-nerve/.

  138. Center for Responsive Politics. Annual lobbying by Cyberonics Inc. https://www.opensecrets.org/lobby/clientsum.php?id=D000049935&year=2015. Accessed August 15, 2016.

  139. Smith EB. Special report: Insiders made nearly $50M trading a money-losing company’s stock. USA Today 2006. http://usatoday30.usatoday.com/money/companies/management/2006-11-20-cyberonics-usat_x.htm.

  140. Is Tony Coelho a crook? Slate 2000. http://www.slate.com/articles/news_and_politics/explainer/2000/04/is_tony_coelho_a_crook.html.

  141. Union of Concerned Scientists. FDA medical device approval based on politics, not science. 2009. http://www.ucsusa.org/our-work/center-science-and-democracy/promoting-scientific-integrity/fda-medical-device-approval.html#.V4apZzWi4ZE.

  142. Nakashima E, Rein L. FDA staffers sue agency over surveillance of personal e-mail. Washington Post 2012. https://www.washingtonpost.com/world/national-security/fda-staffers-sue-agency-over-surveillance-of-personal-e-mail/2012/01/23/gIQAj34DbQ_story.html.

  143. Feder BJ. Head of Cyberonics resigns as options inquiry expands. New York Times 2006. http://www.nytimes.com/2006/11/21/business/21device.html?dlbk.

  144. VNS message board. http://www.vnsmessageboard.com/.

  145. Iriarte J, Urrestarazu E, Alegre M, et al. Late-onset periodic asystolia during vagus nerve stimulation. Epilepsia. 2009;50(4):928–932. https://www.ncbi.nlm.nih.gov/pubmed/19055490.

  146. Bryan Olin. E-mail from Cyberonics to The BMJ. March 15, 2010.

  147. Junod SW. FDA and clinical drug trials: a short history. 2016. http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm304485.htm.

  148. Lex JR, Jr. Dr. Joseph Rohan Lex, Jr., MD, FAAEM: the physician-pharmaceutical industry relationship. J Law Health. 2004;18(2):323. http://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1126&context=jlh.

  149. Mann H, Djulbegovic B. Comparator bias: why comparisons must address genuine uncertainties. JLL Bulletin: Commentaries on the history of treatment evaluation. 2012. http://www.jameslindlibrary.org/articles/comparator-bias-why-comparisons-must-address-genuine-uncertainties/.

  150. Hoffmann TC, Del Mar C. Patients’ expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015;175(2):274–286. http://dx.doi.org/10.1001/jamainternmed.2014.6016.

  151. Hoffmann TC, Del Mar C. Clinicians’ expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2017;177(3):407–419. http://dx.doi.org/10.1001/jamainternmed.2016.8254.

  152. Lenzer J. Why aren’t the US Centers for Disease Control and Food and Drug Administration speaking with one voice on flu? BMJ. 2015-02-05 14:40:22, 2015;350. http://www.bmj.com/content/350/bmj.h658.

  153. Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ. 2009;339(dec07_2):b5106. http://www.bmj.com/cgi/content/abstract/339/dec07_2/b5106.

  154. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2(8):e124. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124.

  155. Ioannidis JP. Contradicted and initially stronger effects in highly cited clinical research. JAMA 200
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  156. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry. 2006;163(2):185–194. PM:16449469.

  157. Brownlee S, Lenzer J. The problem with medicine: we don’t know if most of it works. Discover 2010. http://discovermagazine.com/2010/nov/11-the-problem-with-medicine-dont-know-if-most-works.

  158. MAUDE: Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextSearch.cfm.

  159. Phone interview with Diana Zuckerman, May 21, 2016.

  160. Phone interview with Mark Bruley, May 14, 2009.

  161. Cyberonics. Issue report [into Dennis Fegan’s case]. Released under the FOIA from the State of Texas Department of Health investigation 8/25/2009.

  162. Armstrong R, Parnis S, Scott T, inventors; Google Patents, assignee. Providing multiple signal modes for a medical device. 2007. https://encrypted.google.com/patents/US20070100377.

  163. Barrett B, Parnis S, Maschino S, Guzman A, inventors; Google Patents, assignee. Cranial nerve stimulation to treat a hearing disorder. 2007. http://www.google.com.gi/patents/US20070027504.

  164. Inman D, Parnis S, Guzman A, inventors; Google Patents, assignee. Method and apparatus for forming insulated implantable electrodes. 2007. https://www.google.com/patents/US20070255320.

  165. Maschino S, Parnis S, Armstrong S, inventors; Google Patents, assignee. Identification of electrodes for nerve stimulation in the treatment of eating disorders. 2006. https://www.google.com/patents/US7310557.

  166. Maschino SE, Parnis SM, Buras WR, Guzman AW, inventors; Google Patents, assignee. Stimulating cranial nerve to treat disorders associated with the thyroid gland. 2010. https://www.google.com/patents/US7706874.

  167. Parnis S, Maschino S, Buras W, Guzman A. Stimulating cranial nerve to treat pulmonary disorder. Google Patents; 2007. http://www.google.com.gt/patents/US20070027496.

  168. Parnis SM, Maschino SE, Guzman AW. Cranial nerve stimulation to treat a vocal cord disorder. Google Patents; 2010. http://www.google.com/patents/US7840280.