The Danger Within Us

by Jeanne Lenzer

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  271. Feeley J. J&J to pay as much as $420 million more in ASR hip accord. Bloomberg News 2015. http://www.bloomberg.com/news/articles/2015-02-23/j-j-to-pay-as-much-as-420-million-more-in-asr-hip-accord.

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  277. Wise J. TV show House helped doctors spot cobalt poisoning. BMJ. 2014;348. http://www.bmj.com/content/bmj/348/bmj.g1424.full.pdf.

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  279. E-mail from William Maisel to Stephen Tower. April 30, 2012.

  280. Meier B. Johnson & Johnson in Deal to Settle Hip Implant Lawsuits. New York Times 2013. http://www.nytimes.com/2013/11/20/business/johnson-johnson-to-offer-2-5-billion-hip-device-settlement.html

  281. Pijls BG, Meessen JMTA, Schoones JW, et al. Increased mortality in metal-on-metal versus non-metal-on-metal primary total hip arthroplasty at 10 years and longer follow-up: a systematic review and meta-analysis. PLoS One. 2016;11(6):e0156051. http://dx.doi.org/10.1371%2Fjournal.pone.0156051.

  282. Phone interviews with Dr. Kathleen Yaremchuk, May 25, 2016, and February 25, 2017.

  283. Yaremchuk KL, Toma MS, Somers ML, Peterson E. Acute airway obstruction in cervical spinal procedures with bone morphogenetic proteins. Laryngoscope. 2010;120(10):1954–1957. https://www.ncbi.nlm.nih.gov/pubmed/20824786.

  284. MAUDE report “Infuse” death. 12/12/2008. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1289583.

  285. Buchowski JM, Riew KD, Nussenbaum B. In reference to “Acute airway obstruction in cervical spinal procedures with bone morphogenetic proteins.” Laryngoscope. 2011;121(11):2501; author reply 2502–2503. https://www.ncbi.nlm.nih.gov/pubmed/21898420.

  286. Greene J. Doctor creates system to put limits on sales representatives. Crain’s Detroit Business 2009. http://www.crainsdetroit.com/print/article/20090809/AWARDS05/308099992/doctor-creates-system-to-put-limits-on-sales-representatives.

  287. Epstein NE, Schwall GS. Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010. Surg Neurol Int. 2011;2:115. https://www.ncbi.nlm.nih.gov/pubmed/21886888.

  288. FDA public health notification: life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm.

  289. Epstein NE. Complications due to the use of BMP/INFUSE in spine surgery: the evidence continues to mount. Surg Neurol Int. 2013;4(Suppl 5):S343–352. https://www.ncbi.nlm.nih.gov/pubmed/23878769.

  290. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011;11(6):471–491. http://dx.doi.org/10.1016/j.spinee.2011.04.023.

  291. Carragee EJ, Chu G, Rohatgi R, et al. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. J Bone Joint Surg Am. 2013;95(17):1537–1545. http://jbjs.org/content/jbjsam/95/17/1537.full.pdf.

  292. Devine JG, Dettori JR, France JC, Brodt E, McGuire RA. The use of rhBMP in spine surgery: is there a cancer risk? Evid Based Spine Care J. May, 2012;3(2):35–41. https://www.ncbi.nlm.nih.gov/pubmed/23230416.

  293. Lew v. Medtronic. Case number CV 14-08303-JLS (VBKx). United States District Court for the Central District of California; 2014. http://www.leagle.com/decision/In%20FDCO%2020141217940/Lew%20v.%20Medtronic,%20Inc

  295. Rubenstein S. Grassley points to another academic doctor’s industry pay. Wall Street Journal Health Blog 2009. http://blogs.wsj.com/health/2009/05/28/grassley-points-to-another-academic-doctors-pay-from-industry/.

  296. Terhune C. UC OKs paying surgeon $10 million in whistleblower-retaliation case. Los Angeles Times 2014. http://www.latimes.com/business/la-fi-ucla-doctor-conflicts-20140423-story.html.

  297. Terhune C. Regents OK $8.5 million for 2 patients suing over financial conflicts at UCLA. Los Angeles Times 2016. http://www.latimes.com/business/la-fi-ucla-wang-medtronics-20160729-snap-story.html.

  298. Jerome Lew v. Jeffrey C. Wang, M.D. Regents of the University of California case number: SC120518, Superior Court of the State of California, County of Los Angeles, Central District.

  299. Phone interview with Nancy Epstein, May 24, 2016.

  300. Epstein NE. Are recommended spine operations either unnecessary or too complex? Evidence from second opinions. Surg Neurol Int. 2013;4(Suppl 5):S353–358. https://www.ncbi.nlm.nih.gov/pubmed/24340231.

  301. Phone interview with Eugene J. Carragee, May 5, 2016.

  302. Fauber J. Senators investigate Medtronic spine device. Milwaukee Journal Sentinel 2011. http://www.medpagetoday.com/surgery/orthopedics/27200.

  303. Staff report on Medtronic’s influence on INFUSE clinical studies. Int J Occup Environ Health. 2013;19(2):67–76. http://dx.doi.org/10.1179/2049396713Y.0000000020.

  304. Moore J. Suit alleges that Medtronic tried to entice doctors to use its device. StarTribune. Dec 11, 2008.

  305. Young R. Carragee must resign. Orthopedics This Week 2013. https://ryortho.com/2013/06/dr-eugene-carragee-must-resign/.

  306. Spencer J, Carlson J, Webster M. Question of risk: Medtronic’s lost study. StarTribune 2016. http://www.startribune.com/question-of-risk-medtronic’s-lost-Infuse-study/372957441/.

  307. Hustedt JW, Blizzard DJ. The controversy surrounding bone morphogenetic proteins in the spine: a review of current research. Yale J Biol Med. 2014;87(4):549–561. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4257039/.

  308. Andrew Hagerty v. Cyberonics, Inc., Aug 8, 2012 (United States District Court for the District of Massachusetts Case 1:12-cv-11465-FDS).

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  310. Carlat D. Dr. drug rep. New York Times 2007. http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html?sq=daniel%20carlat%20shame&st=cse&scp=1&pagewanted=print.

  311. Lenzer J, Brownlee S. Doctor takes “march of shame” to atone for drug company payments. BMJ. 2008;336(7634):20–21. http://www.bmj.com/cgi/content/full/336/7634/20.

  312. Brownlee S, Lenzer J. Medical devices that can kill. Reader's Digest 2010. http://www.center4research.org/medical-devices-can-kill/.

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  314. E-mail from William Maisel, MD, MPH, to Dennis Fegan, Dec 31, 2010.

  315. Husten L. Cardiologist William Maisel arrested in prostitution sting operation. Forbes 2012. http://www.forbes.com/sites/larryhusten/2012/08/01/cardiologist-william-maisel-arrested-in-prostitution-sting-operation/#19a121eb397f.

  316. Coronado O. Police incident report, Corpus Christi PD
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  317. Letter from Jay L. Winckler, Winckler & Harvey, to Dennis Fegan, 2008.

  319. Ehrhardt S, Appel LJ, Meinert CL. Trends in National Institutes of Health funding for clinical trials registered in clinicaltrials.gov. JAMA. 2015;314(23):2566–2567. http://dx.doi.org/10.1001/jama.2015.12206.

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  323. Smith R. A successful and cheerful whistleblower. BMJ Blog 2010. http://blogs.bmj.com/bmj/2012/10/10/richard-smith-a-successful-and-cheerful-whistleblower/.

  324. Personal communication with Peter Wilmshurst.

  325. Wilmshurst PT, Thompson DS, Juul SM, et al. Effects of intracoronary and intravenous amrinone infusions in patients with cardiac failure and patients with near normal cardiac function. Br Heart J. 1985;53(5):493–506. https://www.ncbi.nlm.nih.gov/pubmed/3994862.

  326. Wilmshurst P. The politics of disclosure [letter; comment]. Lancet. 1997;349(9050):510. PM:0009040612.

  327. Wilmshurst P. Obstacles to honesty in medical research. HealthWatch. 2003. https://www.healthwatch-uk.org/20-awards/award-lectures/65-2003-dr-peter-wilmshurst.html.

  328. Massie B, Bourassa M, DiBianco R, et al. Long-term oral administration of amrinone for congestive heart failure: lack of efficacy in a multicenter controlled trial. Circulation. 1985;71(5):963–971. https://www.ncbi.nlm.nih.gov/pubmed/3886191.

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  331. Boseley S. Warning signs on doctors’ roadshow. The Guardian 2001. https://www.theguardian.com/society/2001/feb/15/uknews2.

  332. Broad WJ. Notorious Darsee case shakes assumptions about science. New York Times 1983. https://scholar.google.com/scholar?cluster=13739026994092975982&hl=en&as_sdt=0,33.

  333. Oransky O. Coming clean: a major figure in cardiology publishes a lengthy conflict of interest correction in JAMA. Retraction Watch 2012. http://retractionwatch.com/2012/02/07/coming-clean-a-major-figure-in-cardiology-publishes-a-lengthy-conflict-of-interest-correction-in-jama/.

  334. Wallis C. Fraud in a Harvard lab. Time 1983. http://content.time.com/time/magazine/article/0,9171,955142-1,00.html.

  335. Dingell JD. Misconduct in medical research. N Engl J Med. 1993;328(22):1610–1615. http://www.nejm.org/doi/full/10.1056/NEJM199306033282207.

  336. Boffey P. Study accusing researchers of inaccuracies is published. New York Times 1987. http://www.nytimes.com/1987/01/15/us/study-accusing-researchers-of-inaccuracies-is-published.html.

  337. Boffey P. Major study points to faulty research at two universities. New York Times 1986. http://www.nytimes.com/1986/04/22/science/major-study-points-to-faulty-research-at-two-universities.html?pagewanted=all.

  338. Stewart WW, Feder N. The integrity of the scientific literature. Nature. 1987;325(6101):207–214. https://www.ncbi.nlm.nih.gov/pubmed/3808019.

  339. Braunwald E. On analyzing scientific fraud. Nature. 1987;325(6101):215–216.

  340. Braunwald E, Kloner RA. Retraction of “Early recovery of regional performance in salvaged ischemic myocardium following coronary artery occlusion in the dog.” J Clin Invest. 1982;70(4):following 915. https://www.ncbi.nlm.nih.gov/pubmed/6765636.

  341. Bylinsky G. Genentech has a golden goose. Fortune 1988. http://archive.fortune.com/magazines/fortune/fortune_archive/1988/05/09/70518/index.htm.

  342. Marsa L. Prescription for Profits: How the Pharmaceutical Industry Bankrolled the Unholy Alliance Between Science and Business. New York: Scribner; 1997.

  343. E-mail from Genentech, August 25, 2016.

  344. Stampfer MJ, Goldhaber SZ, Yusuf S, Peto R, Hennekens CH. Effect of intravenous streptokinase on acute myocardial infarction. N Engl J Med. 1982;307(19):1180–1182. http://www.nejm.org/doi/full/10.1056/NEJM198211043071904.

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  350. Sherry S, Marder VJ. Creation of the recombinant tissue plasminogen activator (rt-PA) image and its influence on practice habits. J Am Coll Cardiol. 1991;18(6):1579–1582. https://www.ncbi.nlm.nih.gov/pubmed/1939964.

  351. GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico. Lancet. 1990;336(8707):65–71. https://www.ncbi.nlm.nih.gov/pubmed/1975321.

  352. ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. Lancet. 1992;339(8796):753–770. https://www.ncbi.nlm.nih.gov/pubmed/1347801.

  353. Maatz CT. University physician-researcher conflicts of interest: the inadequacy of current controls and proposed reform. Berkeley Technology Law Journal. 1992;7(1). http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1102&context=btlj.

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  359. Phone interview
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  360. Wen P. Jurors outraged by psychiatrist’s conduct. Boston Globe 2010. http://archive.boston.com/news/local/massachusetts/articles/2010/02/11/jurors_outraged_by_psychiatrists_conduct/.

  361. Harris G, Carey B. Researchers fail to reveal full drug pay. New York Times 2008. http://www.nytimes.com/2008/06/08/us/08conflict.html.

  362. Harris G. Top psychiatrist didn’t report drug makers’ pay. New York Times 2008. http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=0.

  363. Lenzer J. Review launched after Harvard psychiatrist failed to disclose industry funding. BMJ. 2008;336(7657):1327–1132a. http://www.bmj.com/cgi/content/short/336/7657/1327-a.

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  365. Chan PS, Patel MR, Klein LW, et al. Appropriateness of percutaneous coronary intervention. JAMA. 2011;306(1):53–61. http://dx.doi.org/10.1001/jama.2011.916.

  366. Gulba DC, Lichtlen PR. rt-PA versus streptokinase—has the controversy regarding the optimal thrombolytic agent been resolved by results of the GISSI II/International rt-PA vs. streptokinase fatality study? Z Kardiol. 1991;80(1):1–5. https://www.ncbi.nlm.nih.gov/pubmed/2035282.

  367. Garattini S, Bertele V, Bertolini G. A failed attempt at collaboration. BMJ. 2013;347. http://www.bmj.com/content/bmj/347/bmj.f5354.full.pdf.

  368. Lenzer J. Experts and activists discuss how to get “right care” for patients. BMJ. 2016-04-29 11:21:06, 2016;353. http://www.bmj.com/content/353/bmj.i2406.

  369. Gawande A. The hot spotters: can we lower medical costs by giving the neediest patients better care? New Yorker 2011. http://www.newyorker.com/magazine/2011/01/24/the-hot-spotters.

  370. Geyman J. Hijacked—stolen health care reform: why health care costs will not be contained. Physicians for a National Health Program. 2010. http://pnhp.org/blog/2010/07/08/hijacked-stolen-health-care-reform-why-health-care-costs-will-not-be-contained/.

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