The Danger Within Us

by Jeanne Lenzer

  169. Zabara J, Barrett BT, Parnis SM. Nerve stimulation as a treatment for pain. Google Patents; 2003. https://www.google.com/patents/WO2003063959A1?cl=en.

  170. Phone interview with Madris Tomes, July 18, 2016.

  171. Chudnoff SG, Nichols JE, Jr., Levie M. Hysteroscopic Essure inserts for permanent contraception: extended follow-up results of a phase III multicenter international study. J Minim Invasive Gynecol. 2015;22(6):951–960. http://www.ncbi.nlm.nih.gov/pubmed/25917278.

  172. Casey J, Yunker A. Pelvic pain associated with Essure perforation. J Minim Invasive Gynecol. 2016;23(3):292.

  173. Casey J, Aguirre F, Yunker A. Outcomes of laparoscopic removal of the Essure sterilization device for pelvic pain: a case series. Contraception. 2016;94(2):190–192.

  174. Barbosa MW, Sotiriadis A, Papatheodorou SI, Mijatovic V, Nastri CO, Martins WP. High miscarriage rate in women submitted to Essure for hydrosalpinx before embryo transfer: a systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2016;48(5):556–565.

  175. Mao J, Pfeifer S, Schlegel P, Sedrakyan A. Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study. BMJ. 2015;351:h5162. http://www.ncbi.nlm.nih.gov/pubmed/26462857.

  176. Food and Drug Administration Center for Devices and Radiological Health Obstetrics and Gynecology Devices Panel materials archive. 2002. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfadvisory/details.cfm?mtg=330.

  177. Gariepy AM, Xu X, Creinin MD, Schwarz EB, Smith KJ. Hysteroscopic Essure inserts for permanent contraception: extended follow-up results of a phase III multicenter international study. J Minim Invasive Gynecol. 2016;23(1):137–138. https://www.ncbi.nlm.nih.gov/pubmed/26260301.

  178. Awford J. “If 20,000 penises were falling off, the world would stop”: Erin Brockovich backs women who claim a commercial contraceptive has left them in agony and needing abortions. Daily Mail Australia 2015. http://www.dailymail.co.uk/news/article-3298878/Erin-Brockovich-joins-campaign-pull-Essure-contraceptive-market.html#ixzz4K2Hsotaq.

  179. Letter from Dayle Cristinzio, acting associate commissioner for legislation, FDA, to the Honorable Michael G. Fitzpatrick. 2016.

  180. Letter from Jay Winckler, Winckler & Harvey, LLP, to Dennis Fegan, May 12, 2008.

  181. Riegel v. Medtronic oral argument. Cornell University Law School Legal Information Institute. Dec 4, 2007. https://www.law.cornell.edu/supct/cert/06-179.

  182. Riegel v. Medtronic US Supreme Court ruling. Feb 20, 2008. https://www.supremecourt.gov/opinions/07pdf/06-179.pdf.

  183. Mencimer S. Daniel Troy’s poison pill. Mother Jones 2008. http://www.motherjones.com/politics/2008/03/daniel-troys-poison-pill.

  184. DeVaney DB, Hamilton PA. The 10,000 pound gorilla: federal preemption in class III medical device cases. Florida Bar Journal 2006. http://www.thefreelibrary.com/The+10%2c000+pound+gorilla%3a+federal+preemption+in+class+III+medical…-a0152762815.

  185. McGarity TO. The perils of preemption. Trial 2008.

  186. FDA history part iv: regulating cosmetics, devices, and veterinary medicine after 1938. http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055137.htm.

  187. Sivin I. Another look at the Dalkon Shield: meta-analysis underscores its problems. Contraception. 1993;48(1):1–12.

  188. Cox ML. The Dalkon Shield saga. J Fam Plann Reprod Health Care. 2003;29(1):8. https://www.ncbi.nlm.nih.gov/pubmed/12626170.

  189. Daniel Schultz resigns amid CDRH controversies. MDDI News 2009. http://www.mddionline.com/article/daniel-schultz-resigns-amid-cdrh-controversies.

  190. Garber AM. Modernizing device regulation. N Engl J Med. 2010;362(13):1161–1163. http://content.nejm.org/cgi/reprint/362/13/1161.pdf.

  191. Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med. 2014;174(11):1781–1787. http://dx.doi.org/10.1001/jamainternmed.2014.4193.

  192. Medtronic, Inc. v. Lohr. Cornell University Law School Legal Information Institute. 1996. https://www.law.cornell.edu/supct/html/95-754.ZS.html.

  193. Phone interview with Vinay Prasad, August 1, 2016.

  194. US Food and Drug Administration. List of device recalls. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm.

  195. US Food and Drug Administration. PMA supplements and amendments. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050467.htm.

  196. Sperling MR. Sudden unexplained death in epilepsy. Epilepsy Currents. 2001;1(1):21–23. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC320690/.

  197. Gordon A. The Delicate Dance of Immersion and Insulation: The Politicization of the FDA Commissioner. 2003. https://dash.harvard.edu/bitstream/handle/1/8852141/Gordon.html?sequence=2.

  198. Phone interview with Larry Kessler, October 24, 2016.

  199. Silverman E. The FDA “revolving door” fosters conflicts on advisory panels. Wall Street Journal Blog 2014. http://blogs.wsj.com/pharmalot/2014/09/15/the-fda-revolving-door-fosters-conflicts-on-advisory-panels/.

  200. Escobar C. He’s back! Former VP at Monsanto to advise FDA commissioner on food safety. Huffington Post 2011. http://www.huffingtonpost.com/christine-escobar/hes-back-former-vp-at-mon_b_228792.html.

  201. Carome M. Outrage of the month: revolving door at FDA undermines public confidence. Public Citizen. 2014. http://www.citizen.org/Page.aspx?pid=6298.

  202. Lenzer J. Robert Califf: controversial new head of the FDA. BMJ. July 5, 2016 10:36:07, 2016;354. http://www.bmj.com/content/354/bmj.i3656.

  203. Lenzer J. Bush plans to screen whole US population for mental illness. BMJ. 2004;328(7454):1458. http://www.bmj.com/content/328/7454/1458.1.

  204. McGarity TO. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.

  205. Scott BG, Strickland EK. Recent developments in federal preemption of pharmaceutical drug and medical device product liability claims. The Defender 2009. http://www.spilmanlaw.com/media%20content/media-content/documents/preemption-developments.pdf.

  206. Lenzer J. Doctors join protest over change to FDA rules on conflict of interest. BMJ. 2011;343:d5269. http://www.ncbi.nlm.nih.gov/pubmed/21852346.

  207. Lenzer J. FDA is criticised for hinting it may loosen conflict of interest rules. BMJ. 2011;343:d5070. http://www.ncbi.nlm.nih.gov/pubmed/21824909.

  208. Lenzer J. FDA bars own expert from evaluating risks of painkillers. BMJ. 2004;329(7476):1203. http://bmj.bmjjournals.com/cgi/content/full/329/7476/1203?ehom.

  209. Harris G. New study links Pfizer’s Bextra, similar to Vioxx, to heart attacks. New York Times 2004. http://www.nytimes.com/2004/11/10/business/new-study-links-pfizers-bextra-similar-to-vioxx-to-heart-attacks.html?_r=0.

  210. Lenzer J. When is a point of view a conflict of interest? BMJ. 2016;355. http://www.bmj.com/content/bmj/355/bmj.i6194.full.pdf.

  211. Steinbrook R. Financial conflicts of interest and the Food and Drug Administration’s advisory committees. N Engl J Med. 2005;353(2):116–118. http://www.nejm.org/doi/full/10.1056/NEJMp058108.

  212. Lurie P. Financial conflicts of interest are related to voting patterns at FDA advisory committee meetings. MedGenMed. 2006;8(4):22–22. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1868362/.

  213. Lenzer J, Epstein K. The Yaz men: members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties. Washington Monthly 2012. http://www.washingtonmonthly.com/ten-miles-square/2012/01/the_yaz_men_members_of_fda_pan034651.php.

  214. 2012 presidential race: health sector totals to candidates. Center for Responsive Politics. http://www.opensecrets.org/pres12/sectors.php?sector=H.

  215. Greenfieldboyce N. FDA to fund controversial research foundation. All Things Considered 2012. http://www.npr.org/sections/health-shots/2012/04/03/149931282/fda-to-fund-controversial-research-foundation.

  216. Johnson JA. The FDA Medical Dev
ice User Fee Program: MDUFA IV Reauthorization. 2016. https://www.fas.org/sgp/crs/misc/R44517.pdf.

  217. Partnership for Public Service. The State of the FDA Workforce. 2012. https://ourpublicservice.org/publications/viewcontentdetails.php?id=43.

  218. Mandrola J. Double counting… DrJohnM. http://www.drjohnm.org/2010/07/double-counting/.

  219. Groeger L. Four medical implants that escaped FDA scrutiny. ProPublica 2012. https://www.propublica.org/special/four-medical-implants-that-escaped-fda-scrutiny.

  220. Layton L. FDA look again at knee implant after reports of pressure. Washington Post 2009. http://www.washingtonpost.com/wp-dyn/content/article/2009/09/24/AR2009092404272.html.

  221. Harris G, Halbfinger DM. F.D.A. reveals it fell to a push by lawmakers. New York Times 2009. http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=0.

  222. Ivy Sports Medicine has first implantation of the collagen meniscus implant (CMI). 2015. http://www.ivysportsmed.com/en/about-us/news.

  223. University of Michigan Fast Forward Medical Innovation. FDA Regulation of Medical Devices (Part 1 of 3). 2015. https://www.youtube.com/watch?v=yZAG51ogVhE.

  224. Institute of Medicine. Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: National Academies Press; 2011.

  225. Letter to President Obama from FDA physicians, scientists. 2009. https://www.finance.senate.gov/ranking-members-news/letter-to-president-obama-from-fda-physicians-scientists.

  226. Hardy v. Shuren: second amended complaint. Case number 1:11-CV-01739-RLW. United States District Court for the District of Columbia; 2012. legaltimes.typepad.com/files/fda2.pdf.

  227. Zuckerman D. Why the 21st Century Cures Act could be disastrous for medicine. National Center for Health Research. 2016. http://www.center4research.org/21st-century-cures-act-disastrous-medicine/.

  228. Lenzer J. Manufacturers tell FDA why they should be able to promote drugs and devices off label. BMJ. 2016;355. http://www.bmj.com/content/bmj/355/bmj.i6098.full.pdf.

  229. Spencer J, Carlson J. In letter to Franken, FDA defends handling of Medtronic’s Infuse study. StarTribune 2016. http://www.startribune.com/in-letter-to-franken-fda-defends-handling-of-medtronic-s-infuse-study/384052101/.

  230. Lenzer J. Watching over the medical device industry. BMJ. 2009;338:b2321. http://www.bmj.com/cgi/content/full/338/jun23_1/b2321?view=long&pmid=19549649.

  231. Lenzer J. Is the United States Preventive Services Task Force still a voice of caution? BMJ. 2017;356. http://www.bmj.com/content/bmj/356/bmj.j743.full.pdf.

  232. Novella S. The role of anecdotes in science-based medicine. Science-Based Medicine 2008. https://sciencebasedmedicine.org/the-role-of-anecdotes-in-science-based-medicine/.

  233. Kosko J, Klassen TP, Bishop T, Hartling L. Evidence-based medicine and the anecdote: uneasy bedfellows or ideal couple? Paediatr Child Health. 2006;11(10):665–668. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528597/.

  234. Shukla GP, Asuri N. Natural history of temporal lobe epilepsy: antecedents and progression. Epilepsy Research and Treatment. 2012;2012. http://dx.doi.org/10.1155/2012/195073.

  235. Kwan P, Sander JW. The natural history of epilepsy: an epidemiological view. J Neurol, Neurosurg Psychiatry. 2004;75(10):1376–1381. http://jnnp.bmj.com/content/75/10/1376.abstract.

  236. Barrette S, Bernstein ML, Leclerc JM, et al. Treatment complications in children diagnosed with neuroblastoma during a screening program. J Clin Oncol. 2006;24(10):1542–1545. http://jco.ascopubs.org/cgi/content/abstract/24/10/1542.

  237. Tsubono Y, Hisamichi S. A halt to neuroblastoma screening in Japan. N Engl J Med. 2004;350(19):2010–2011. http://www.nejm.org/doi/full/10.1056/NEJM200405063501922.

  238. Woods WG, Gao RN, Shuster JJ, et al. Screening of infants and mortality due to neuroblastoma. N Engl J Med. 2002;346(14):1041–1046. http://content.nejm.org/cgi/content/abstract/346/14/1041.

  239. Prasad V, Rho J, Cifu A. The inferior vena cava filter: how could a medical device be so well accepted without any evidence of efficacy? JAMA Intern Med. 2013;173(7):493–495. http://dx.doi.org/10.1001/jamainternmed.2013.2725.

  240. Terra VC, Furlanetti LL, Nunes AA, et al. Vagus nerve stimulation in pediatric patients: is it really worthwhile? Epilepsy Behav. 2014;31:329–333. http://www.ncbi.nlm.nih.gov/pubmed/24210463.

  241. Cyberonics Physician’s Manual VNS Therapy. 1997:240.

  242. Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping doctors and patients make sense of health statistics. Psychol Sci. 2007;8(2):53–96. http://library.mpib-berlin.mpg.de/ft/gg/GG_Helping_2008.pdf.

  243. Transmyocardial laser revascularization. N Engl J Med. 2000;342(6):436–438. http://www.nejm.org/doi/full/10.1056/NEJM200002103420615.

  244. Briones E, Lacalle JR, Marin-Leon I, Rueda J-R. Transmyocardial laser revascularization versus medical therapy for refractory angina. Cochrane Database Syst Rev. 2015(2). http://dx.doi.org/10.1002/14651858.CD003712.pub3.

  245. Musial F, Klosterhalfen S, Enck P. Placebo responses in patients with gastrointestinal disorders. World J Gastroenterol. 2007;13(25):3425–3429. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4146777/.

  246. Jacoby VL, Subak L, Waetjen L. The FDA and the vaginal mesh controversy—further impetus to change the 510(k) pathway for medical device approval. JAMA Intern Med. 2016;176(2):277–278. http://dx.doi.org/10.1001/jamainternmed.2015.7155.

  247. Cyberonics. Brief Summary of Safety Information for the VNS Therapy System [Epilepsy and Depression Indications] (March 2007). http://dynamic.cyberonics.com/manuals/doc_download.asp?docid=1380E48A-8094-4D9F-AA9A-22E5466435D1.

  248. Cyberonics. Physician’s Manual VNS Therapy Pulse Model 102 Generator and VNS Therapy Pulse Duo Model 102R Generator. 2003. https://www.fda.gov/ohrms/dockets/ac/04/briefing/4047b1_03_Epilepsy%20Physician%27s%20Manual.pdf.

  249. Glorioso C, Schlesinger J, Stulberger E. Health companies label thousands of patient deaths as “injuries.” CNBC. 2016. http://www.cnbc.com/2016/08/19/health-companies-label-thousands-of-patient-deaths-as-injuries.html.

  250. Lenzer J. FOIA Request: FDA response to inquiry by Senator Solomon P. Ortiz re: VNS investigation; post-surveillance studies Jan 1, 1997 through May 16, 2016.

  251. E-mails from Celeste Smith, Deputy Agency Chief, FOIA Officer, Aug 16, 17, and 23, 2016.

  252. Labar D. Vagus nerve stimulation for 1 year in 269 patients on unchanged antiepileptic drugs. Seizure. 2004;13(6):392–398. PM:15276142.

  253. Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002;59(90064):26S–30. http://www.neurology.org/cgi/content/abstract/59/6_suppl_4/S26.

  254. Labar DR. Antiepileptic drug use during the first 12 months of vagus nerve stimulation therapy: a registry study. Neurology. 2002;59(90064):38S–43. http://www.neurology.org/cgi/content/abstract/59/6_suppl_4/S38.

  255. Helmers SL, Griesemer DA, Dean JC, et al. Observations on the use of vagus nerve stimulation earlier in the course of pharmacoresistant epilepsy: patients with seizures for six years or less. Neurologist. 2003;9(3):160–164.

  256. Amar AP, Apuzzo MLJ, Liu CY. Vagus nerve stimulation therapy after failed cranial surgery for intractable epilepsy: results from the vagus nerve stimulation therapy patient outcome registry. Neurosurgery. 2004;55(5). http://journals.lww.com/neurosurgery/Fulltext/2004/11000/Vagus_Nerve_Stimulation_Therapy_after_Failed.10.aspx.

  257. Annegers JF, Coan SP, Hauser WA, Leestma J. Epilepsy, vagal nerve stimulation by the NCP system, all-cause mortality, and sudden, unexpected, unexplained death. Epilepsia. 2000;41(5):549–553. http://onlinelibrary.wiley.com/doi/10.1111/j.1528-1157.2000.tb00208.x/pdf

  258. Scherrmann J, Hoppe C, Kral T, Schramm J, Elger CE. Vagus nerve stimulation: clinical experience in a large patient series. J Clin Neurophysiol. 2001;18(5):408–414.

  259. Hoppe C. Vagus nerve stimulation: urgent need for the critical reappraisal of clinical effectiveness. Seizure. 2013;22(1):83–84. http
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  260. Hoppe C, Helmstaedter C, Elger CE. Vagus nerve stimulation for epilepsy treatment in children. Epilepsia. 2015;56(2):323–324. https://www.ncbi.nlm.nih.gov/pubmed/25708479.

  261. Hoppe C, Wagner L, Hoffman J, von Lehe M, Elger CE. Comprehensive long-term outcome of best drug treatment with or without add-on vagus nerve stimulation for epilepsy: a retrospective matched pairs case-control study. Seizure. 2013;22:109–115. https://pdfs.semanticscholar.org/e39d/1e9500ef7110a7e9f4d8a416172096c9cb92.pdf.

  262. Bernstein AL, Barkan H, Hess T. Vagus nerve stimulation therapy for pharmacoresistant epilepsy: effect on health care utilization. Epilepsy Behav. 2007;10(1):134–137. http://www.epilepsybehavior.com/article/S1525-5050(06)00400-8/pdf.

  263. Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007;370(9597):1508–1519.

  264. Tower S. Hip metallosis and corrosion—a million harmed due to FDA inaction. J Patient Saf. Nov 02, 2016. https://www.ncbi.nlm.nih.gov/pubmed/27811592.

  265. Tower SS. Arthroprosthetic cobaltism associated with metal on metal hip implants. BMJ. Jan 17, 2012;344:e430. https://www.ncbi.nlm.nih.gov/pubmed/22252702.

  266. Machado C, Appelbe A, Wood R. Arthroprosthetic cobaltism and cardiomyopathy. Heart Lung Circ. 2012;21(11):759–60. https://www.ncbi.nlm.nih.gov/pubmed/22520206.

  267. Roessler PP, Witt F, Efe T, Schmitt J. Arthroprosthetic cobaltism and pseudotumour also occur in patients with small diameter femoral ball head metal-on-metal total hip arthroplasties. BMJ Case Rep. Mar 28, 2014;2014. https://www.ncbi.nlm.nih.gov/pubmed/24682139.

  268. 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. Jun 12, 2015. https://www.ncbi.nlm.nih.gov/pubmed/26076080.

  269. Tower SS. Cobalt toxicity in two hip replacement patients. State of Alaska Epidemiology Bulletin. 2010. www.epi.alaska.gov/bulletins/docs/b2010_14.pdf.