http://www.ti.ubc.ca/
Unplugged Health and Medicine: Part of the “Quarternary Prevention Movement’s purpose is to work together to create health and well-being.” (Cuba, Peru, Colombia, Chile, Uruguay; posts also available in English)
https://seanimpacientes.wordpress.com/
https://www.facebook.com/SaluDesenchufada
http://www.lessismoremedicine.com/
Up-To-Date: Subscription-based online “text-book” of medicine with continuing medical education, podcasts, calculators, and patient education resources that isn’t 100 percent industry-free but strives to come as close as possible (USA)
http://www.uptodate.com/home
VNS Message Board: Extensive information about the VNS device; Dennis Fegan and Donna Baum post here, along with many others (USA)
http://www.vnsmessageboard.com/
Woody Matters: Focuses on the harm caused by antidepressants (USA)
www.woodymatters.com
Resources for Journalists
Health News Review: Provides the best critical analyses available of media health news reporting (USA)
https://www.healthnewsreview.org/
The List: An international list of industry-independent experts for the media, guidelines panels, and regulatory agencies (USA). Updated list available at:
https://www.jeannelenzer.com/
and
https://www.healthnewsreview.org/
Acknowledgments
I’m deeply indebted to many more people than those whose names appear in this book. However, I’d like to start by thanking Annabel Ferriman, my former editor, who gave me my first break, assigning me to write an investigative piece for The BMJ.
Many years ago, I told Jerry Hoffman that I wanted to write a “biography of his ideas.” He has an enthusiastic following of medical students and doctors who appreciate his incisive analyses of medical research and his decades-long and consistent stance against accepting industry blandishments. While Jerry declined to comment on certain subjects addressed in this book, his influence on my thinking is profound, and virtually all the concepts, analyses, and viewpoints in this book have been in some way touched or influenced by Jerry. Of course, any mistakes are my own.
Shannon Brownlee, my writing partner, dearest friend, colleague, and sparring partner, has not only taught me a good deal about writing but has also taught me how to argue with love. She has been a shining light. Without her, this book would not have been possible.
This book bears the imprint of several medical giants whose time, interviews, and writings have also shaped this book: John Ioannidis, who has repeatedly demonstrated the messiness of medical research and its many distortions; the inimitable Bernard Lown and his colleague Vikas Saini, who both live by Bernard’s creed—“Do as much for patients and as little as possible to patients”; Marcia Angell, whose commitment to disentangling money and medicine has inspired me and many others; and Richard Smith and Fiona Godlee, who as editors in chief of The BMJ set a high bar for medical journals and my own work.
For a better understanding of the FDA, its approval process, oversight in general, and the VNS device in particular, I am grateful to Ronald Kavanagh, Paul Thacker, Diana Zuckerman, Sidney Wolfe, Michael Carome, Marc-André Gagnon, Larry Kessler, Suzanne Parisian, Madris Tomes, and Deborah Zarin. I’d also like to thank several experts who asked not to be named for fear of losing their jobs.
Experts who expanded my understanding of scientific biases, financial conflicts of interest, and institutional corruption include: Joel Lexchin, Jerome Kassirer, Alan Cassels, John Abramson, Vinay Prasad, Peter Goetzsche, Rita Redberg, Otis Brawley, Kenneth Lin, Sheldon Krimsky, Neil Calman, Michael Wilkes, Deb Cohen, Steven Nissen, Adriane Fugh-Berman, Roy Poses, Barnett Kramer, Carl Heneghan, Lisa Bero, Nortin Hadler, Mohammad Zakaria Pezeshki, Steven Woloshin, Gil Welch, Lisa Schwartz, David Himmelstein, Steffie Woolhandler, Howard Brody, and Linda Marsa.
For explanations regarding the problems and possibilities of healthcare delivery, I’m indebted to Wendell Potter, T. R. Reid, John Geyman, and Physicians for a National Health Program. For an inspirational view of what independent research can do, I’m indebted to Donald Light and Antonio Maturo, authors of Good Pharma, and the Mario Negri Institute. I’m also indebted to the many patients who educated me about their experiences with implants, from surgical mesh to certain birth-control implants, whose stories I wasn’t able to include. Their experiences drove me to persist with a “big picture” depiction of the problems, which I hope will in some small way help lead to solutions for this vastly underregulated industry.
The Knight Science Journalism Fellowship and many of my fellow journalists around the globe, especially Gary Schwitzer and the folks at HealthNewsReview, have inspired me, humbled me, and kept me kicking for the many years it took me to write this book—to them and to the Birdies, I am forever grateful.
Thanks to Margaret Cirillo and Mary Evans, who with expert speed kept me supplied with medical articles I requested.
To my agent, Eileen Cope: you’re the best cheerleader a writer could ask for. To Karl Weber, a consulting editor who tore my first manuscript apart and made me write a better book, thank you for your vision and kindness. To Jean Garnet, my editor at Little, Brown, thanks for expecting better after the first submission. To my publisher, I can only thank Eileen for ensuring that I signed with you—she couldn’t have chosen more wisely.
To Dennis Fegan and his family: you were incredibly kind to let me into your homes and lives. Your willingness to share your memories and insights with a stranger, and now the world, is a testament to the humor and strength I observed in your family. Dennis, you kept at it. You persevered. And even when all remedies for you were long gone, you kept working and researching with only the hope that you might help others. You are a star.
And as is so often the case, writing a book can be all-consuming. Not only did my family allow me to pursue this work, but the wisdom and kindness of my husband, John Calhoun, also helped me see shades of gray where I often saw only black and white. Special thanks to my son, Mahtik “Tiki” Calhoun, who was so understanding throughout, and to my wonderful muse, Ada Prior.
Notes
1. Goodman SL, Geiderman JM, Bernstein IJ. Prophylactic lidocaine in suspected acute myocardial infarction. JACEP. 1979;8(6):221–224. http://www.ncbi.nlm.nih.gov/pubmed/449144.
2. Pigman E, Smith M. Prehospital prophylactic lidocaine for uncomplicated acute myocardial infarction [editorial; comment]. J Emerg Med. 1993;11(6):753–755. http://www.ncbi.nlm.nih.gov/pubmed/8157915.
3. Pratt CM, Moye LA. The cardiac arrhythmia suppression trial: casting suppression in a different light. Circulation. 1995;91(1):245–247. http://circ.ahajournals.org/content/91/1/245.full.
4. Newman TB. A black-box warning for antidepressants in children? N Engl J Med. 2004;351(16):1595–1598. PM:15483275.
5. Waxman H. The marketing of Vioxx to physicians. https://democrats-oversight.house.gov/sites/democrats.oversight.house.gov/files/documents/20050505114932-41272.pdf. 2005.
6. Bernadette T. Firm misled doctors on Vioxx, panel says sales staff told not to discuss risk study. San Francisco Chronicle 2005. http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/05/06/VIOXX.TMP.
7. Suz R. Journal: drug sales based on “seriously biased” data: Celebrex, Vioxx cited for problems, claims. Washington Post 2002: HE01.
8. Lenzer J. US government agency to investigate FDA over rofecoxib. BMJ. 2004;329(7472):935. http://bmj.bmjjournals.com/cgi/content/full/329/7472/935.
9. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. Jun 20, 2009, 2009;373(9681):2125–2135. http://dx.doi.org/10.1016/S0140-6736(09)60953-3.
10. Nissen SE, Wolski K. Effect of Rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):245
7–2471. http://content.nejm.org/cgi/content/abstract/356/24/2457.
11. Rosen CJ. The rosiglitazone story—lessons from an FDA advisory committee meeting. N Engl J Med. 2007;357(9):844–846. http://www.nejm.org/doi/full/10.1056/NEJMp078167.
12. Crosse M. Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. United States Government Accountability Office; January 2009. www.gao.gov/assets/290/284882.pdf.
13. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979–2012. JAMA. 2014;311(4):385–391. http://dx.doi.org/10.1001/jama.2013.284986.
14. Johnson JA. FDA Regulation of Medical Devices. Congressional Research Service; Sept 14, 2016. https://fas.org/sgp/crs/misc/R42130.pdf.
15. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24):2679–2685. http://jama.jamanetwork.com/article.aspx?articleid=185124.
16. Braunwald E. A conversation with Eugene Braunwald. Interview by Ushma S. Neill. J Clin Invest. Jan 2, 2013;123(1):1–2. http://www.ncbi.nlm.nih.gov/pubmed/23281402 and https://www.youtube.com/watch?v=Z19mCY-Rb2A.
17. Lee TH. Eugene Braunwald and the Rise of Modern Medicine. Cambridge, MA: Harvard University Press; 2013.
18. Luderitz B. Bernard Lown. J Interv Card Electrophysiol. Jun, 2004;10(3):293–294. https://www.ncbi.nlm.nih.gov/pubmed/15133370.
19. Maddocks I. Bernard Lown and 21 years of International Physicians for Prevention of Nuclear War. Med Confl Surviv. Jan–Mar, 2003;19(1):1–3. https://www.ncbi.nlm.nih.gov/pubmed/12776930.
20. Banerjee A. Bernard Lown: the nonagenarian blogger with a lifelong thirst for combining clinical practice and social responsibility. Eur Heart J. May, 2013;34(18):1316–1317. https://www.ncbi.nlm.nih.gov/pubmed/23802251.
21. Lown B, Amarasingham R, Neuman J. New method for terminating cardiac arrhythmias: use of synchronized capacitor discharge. JAMA. Aug 1, 1986;256(5):621–627. https://www.ncbi.nlm.nih.gov/pubmed/3522950.
22. Eisenberg M. The resuscitation greats. Bernard Lown and defibrillation. Resuscitation. May, 2006;69(2):171–173. https://www.ncbi.nlm.nih.gov/pubmed/16650729.
23. Todd KH, Lee T, Hoffman JR. The effect of ethnicity on physician estimates of pain severity in patients with isolated extremity trauma. JAMA. 1994;271(12):925–928.
24. Miura BR, Schreiger DL, Hoffman JR. What an ED doc will do for a buck: implications for survey research. Ann Emerg Med. Nov, 1997;30(5):713–714. http://www.ncbi.nlm.nih.gov/pubmed/9360591.
25. Hoffman JR, Cooper RJ. Stroke thrombolysis: we need new data, not more reviews. Lancet Neurol. Apr, 2005;4(4):204–205. http://www.ncbi.nlm.nih.gov/pubmed/15778096.
26. Bell DS, Hays RD, Hoffman JR, Day FC, Higa JK, Wilkes MS. A test of knowledge about prostate cancer screening. Online pilot evaluation among Southern California Physicians. J Gen Intern Med. Apr, 2006;21(4):310–314. http://www.ncbi.nlm.nih.gov/pubmed/16499545.
27. Hoffman JR, Cooper RJ. Overdiagnosis of disease: a modern epidemic. Arch Intern Med. 2012;172(15):1123–1124. http://dx.doi.org/10.1001/archinternmed.2012.3319.
28. Kanzaria HK, Hoffman JR, Probst MA, Caloyeras JP, Berry SH, Brook RH. Emergency physician perceptions of medically unnecessary advanced diagnostic imaging. Acad Emerg Med. Apr, 2015;22(4):390–398.
29. Mackenbach JP. Politics is nothing but medicine at a larger scale: reflections on public health’s biggest idea. J Epidemiol Community Health. Mar, 2009;63(3):181–184.
30. Woolf SH, Aron L. US Health in International Perspective: Shorter Lives, Poorer Health: Washington, DC: National Academies Press; 2013.
31. U.S. Health Care from a Global Perspective. Commonwealth Fund; 2015. http://www.commonwealthfund.org/publications/issue-briefs/2015/oct/us-health-care-from-a-global-perspective.
32. World Population Prospects. Volume 1: Comprehensive Tables. 2015 revision. United Nations Department of Economic and Social Affairs; 2015. https://esa.un.org/unpd/wpp/Publications/Files/WPP2015_Volume-I_Comprehensive-Tables.pdf.
33. Mortality in the United States, 2015. Centers for Disease Control and Prevention: National Center for Health Statistics; 2015. https://www.cdc.gov/nchs/products/databriefs/db267.htm.
34. Khazan O. Why American women aren’t living as long as they should. The Atlantic 2014. http://www.theatlantic.com/health/archive/2014/01/why-american-women-arent-living-as-long-as-they-should/282984/.
35. Kindig DA, Cheng ER. Even as mortality fell in most US counties, female mortality nonetheless rose in 42.8 percent of counties from 1992 to 2006. Health Aff. 2013;32(3):451–458. http://content.healthaffairs.org/content/32/3/451.abstract.
36. Olshansky SJ, Antonucci T, Berkman L, et al. Differences in life expectancy due to race and educational differences are widening, and many may not catch up. Health Aff. 2012;31(8):1803–1813. http://content.healthaffairs.org/content/31/8/1803.abstract.
37. Organisation for Economic Co-operation and Development. Daily Smokers. 2014. https://data.oecd.org/healthrisk/daily-smokers.htm#indicator-chart.
38. Organisation for Economic Co-operation and Development. Alcohol Consumption. 2014. https://data.oecd.org/healthrisk/alcohol-consumption.htm.
39. Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. Apr 11, 2012;307(14):1513–1516. https://www.ncbi.nlm.nih.gov/pubmed/22419800.
40. Ferguson TB, Jr. The Institute of Medicine committee report “best care at lower cost: the path to continuously learning health care.” Circ Cardiovasc Qual Outcomes. Nov, 2012;5(6):e93–94. https://www.ncbi.nlm.nih.gov/pubmed/23170008.
41. Health Affairs. Health Policy Brief: Reducing Waste in Health Care. Dec 13, 2012. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_82.pdf.
42. Allen M. How many die from medical mistakes in U.S. hospitals? ProPublica 2013. https://www.propublica.org/article/how-many-die-from-medical-mistakes-in-us-hospitals.
43. Moore TJ, Furberg CD, Cohen MR. Anticoagulants the Leading Reported Drug Risk in 2011. QuarterWatch: Monitoring FDA MedWatch Reports. Institute for Safe Medication Practices2012. http://www.omsj.org/reports/2011Q4.pdf.
44. Wilper AP, Woolhandler S, Lasser KE, McCormick D, Bor DH, Himmelstein DU. Health insurance and mortality in US adults. Am J Public Health. Dec, 2009;99(12):2289–2295. http://www.ncbi.nlm.nih.gov/pubmed/19762659.
45. Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. Aug, 2009;122(8):741–746. http://www.ncbi.nlm.nih.gov/pubmed/19501347.
46. Woolhandler S, Himmelstein DU. Grim prognosis for Massachusetts reform. Health Aff. Mar–Apr, 2009;28(2):604–605; author reply 605. http://www.ncbi.nlm.nih.gov/pubmed/19276039.
47. Himmelstein DU, Thorne D, Woolhandler S. Medical bankruptcy in Massachusetts: has health reform made a difference? Am J Med. Mar, 2011;124(3):224–228. http://www.ncbi.nlm.nih.gov/pubmed/21396505.
48. Kawachi I, Kennedy BP. Health and social cohesion: why care about income inequality? BMJ. 1997;314(7086):1037.
49. Marmot M, Ryff CD, Bumpass LL, Shipley M, Marks NF. Social inequalities in health: next questions and converging evidence. Soc Sci Med. 1997;44(6):901–910.
50. Pappas G, Queen S, Hadden W, Fisher G. The increasing disparity in mortality between socioeconomic groups in the United States, 1960 and 1986. N Engl J Med. 1993;329(2):103–109.
51. Kawachi I, Kennedy BP, Lochner K, Prothrow-Stith D. Social capital, income inequality, and mortality. Am J Public Health. 1997;87(9):1491–1498.
52. Johnston DC. The true cost of national security: the Pentagon and the White House focus on the core defense budget, but that’s not the half of it. Columbia Journalism Review 2013. http://www.cjr.org/united_states_project/the_true_cost_of_national_secu.php.
53. Kaiser Health Tracker. 2016. http://www.healthsystemtracker.org/interactive/?display=U.S.%2
520%2524%2520Billions&service=All%2520Types%2520of%2520Services.
54. Stern AM, Markel H. The history of vaccines and immunization: familiar patterns, new challenges. Health Aff. 2005;24(3):611–621. http://content.healthaffairs.org/content/24/3/611.abstract.
55. Impactscan.org. A brief history of the CT. http://www.impactscan.org/CThistory.htm.
56. Cools J. Improvements in the survival of children and adolescents with acute lymphoblastic leukemia. Haematologica. 2012;97(5):635-635. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342961/.
57. Forkus B. Ear on a mouse. http://openwetware.org/wiki/Ear_on_a_Mouse,_by_Brittany_Forkus.
58. Lenzer J. Have we entered the stem cell era? Discover 2009. http://discovermagazine.com/2009/nov/14-have-we-entered-the-stem-cell-era.
59. American Academy of Anti-Aging Medicine. http://www.a4m.com/.
60. Jenkins HW, Jr. Will Google’s Ray Kurzweil live forever? Wall Street Journal 2013. http://www.wsj.com/articles/SB10001424127887324504704578412581386515510.
61. Transparency International asks health care professionals about health care corruption. 2016. http://hcrenewal.blogspot.com/search/label/health%20care%20corruption.
62. Schneider A, Geewax M. On-the-job deaths spiking as oil drilling quickly expands. All Things Considered. 2013. http://www.npr.org/2013/12/27/250807226/on-the-job-deaths-spiking-as-oil-drilling-quickly-expands.
63. Adams SM, Knowles PD. Evaluation of a first seizure. Am Fam Physician. May 1, 2007;75(9):1342–1347.
64. Holmes G, Sirven J, Fisher RS. Temporal lobe epilepsy. http://www.epilepsy.com/learn/types-epilepsy-syndromes/temporal-lobe-epilepsy.
65. Laxer KD, Trinka E, Hirsch LJ, et al. The consequences of refractory epilepsy and its treatment. Epilepsy Behav. Aug, 2014;37:59–70. http://www.ncbi.nlm.nih.gov/pubmed/24980390.
66. French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3–7.
The Danger Within Us Page 29
