Notes for the Four Box Model

56. Sandra G. Boodman, “Are Doctors To Blame?” Washington Post, 27 May 2008.  This article reports on a Mayo Clinic study that showed that upon hospital discharge only 11 percent of patients said that they had been warned about side effects of new medicines prescribed for them. Many other studies show similar numbers.

57. Tejal K. Gandhi, Saul N. Weingart, Joshua Borus, Andrew C. Seger, Josh Peterson, Elisabeth Burdick, Diane L. Seger, Kirstin Shu, Frank Federico, Lucian L. Leape, and David W. Bates, “Patient Safety: Adverse Drug Events in Ambulatory Care,” New England Journal of Medicine, 17 April 2003.  See also Tejal K. Gandhi and Thomas H. Lee, “Patient Safety Beyond the Hospital,” New England Journal of Medicine, 08 September 2010.

58. Charlene Laino, “Is Your Medicine Cabinet Making You Fat?” http://www.webmd.com/a-to-z-guides/features/is-your-medicine-cabinet-making-you-fat, accessed 29 March 2014.

59. Tejal K. Gandhi, Saul N. Weingart, Joshua Borus, Andrew C. Seger, Josh Peterson, Elisabeth Burdick, Diane L. Seger, Kirstin Shu, Frank Federico, Lucian L. Leape, and David  W. Bates, “Patient Safety: Adverse Drug Events in Ambulatory Care,” New England Journal of Medicine, 17 April 2003.

See also Tejal K. Gandhi and Thomas H. Lee, “Patient Safety Beyond the Hospital,” New England Journal of Medicine, 08 September 2010.

60. Beatrice A. Golomb, John J. McGraw, Marcella A. Evans, and Joel E. Dimsdale, “Physician Response to Patient Reports of Adverse Drug Effects,” Drug Safety, August 2007.

61. Ibid.

62. Ibid.

63. Mary Duenwald, “Is Your Medicine Cabinet Making You Fat?” New York Times, 16 August 2005.

64. Beatrice A. Golomb, John J. McGraw, Marcella A. Evans, and Joel E. Dimsdale, “Physician Response to Patient Reports of Adverse Drug Effects,” Drug Safety, August 2007.

83. http://www.thennt.com/nnt/antibiotics-for-clinically-diagnosed-acute-sinusitis/, accessed 29 March 2014.  Researchers use a statistic called Number Needed to Treat (NNT) to clarify how many people have to take a drug for one person to benefit. NNT is explained further on a website, www.nntonline.net, run by Dr. Chris Cates. Dr. Cates has created a computer program to help doctors understand how to translate research results into more meaningful information to help them better practice medicine.

84. “Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia, Data Show,” Press release, Pfizer, 01 May 2007. “Significantly more patients treated with Lyrica reduced their pain by 50 percent or more compared with placebo. Of those patients taking 600mg of Lyrica a day, 30 percent said their pain was cut in half or better; 27 percent of those taking 450mg a day and 24 percent of those taking 300mg also reported this level of pain relief. Of those taking placebo, 15 percent reported pain reduction of 50 percent or greater.”

See also Lee Bowman, “Study: Diabetes drug cuts risk of disease,” Scripps Howard News Service, 18 September 2006, reporting on a study at McMaster University in Ontario, Canada involving 5,269 patients at 191 sites in 21 countries. Avandia “normalized glucose levels in 51 percent of those who took it, compared with 30 percent in the placebo group.”

See also John Carey, “Do Cholesterol Drugs Do Any Good?” Business Week, 16 January 2008. “Difficult risk-benefit questions surround most drugs. . . . One dirty little secret of modern medicine is that many drugs work only in a minority of people.”

86. Roni Caryn Rabin and Nicholas Bakalar, “Hazards: A Pacemaker is Found to Carry Risk,” New York Times, 20 June 2011, reporting on a study in the Archives of Internal Medicine.

88. John Carey, “Do Cholesterol Drugs Do Any Good?” Business Week, 17 January 2008. Researchers use a statistic called Number Needed to Treat (NNT) to clarify how many people have to take a drug for one person to benefit. Often, “The NNTs are large. Take Avandia, GlaxoSmithKline’s drug for preventing the deadly progression of diabetes.  The blockbuster, with $2.6 billion in U.S. sales in 2006, made headlines in 2007 when an analysis of clinical trial data showed it increased the risk of heart attacks. The largely untold story: There’s little evidence the drug actually helps patients. Yes, Avandia is very good at lowering blood sugar, just as statins lower cholesterol levels. But that doesn’t translate into preventing the dire consequences of diabetes, including heart disease, strokes, and kidney failure. Clinical trials ‘failed to find a significant reduction in cardiovascular events even with excellent glucose control,’ wrote Dr. Clifford J. Rosen, chair of the Food & Drug Administration committee that evaluated Avandia, in a recent commentary in the New England Journal of Medicine. ‘Avandia is almost the poster child for everything wrong with our system,’ says UCLA’s Hoffman. ‘Its NNT is close to infinite.’”

NNT is explained further on a website, www.nntonline.net, run by Dr. Chris Cates.

On a related note, see Tara Parker-Pope, “A Call for Caution in the Rush to Statins,” New York Times, 18 November 2008. She summarizes a study: “Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.”

See also John Carey, “Smarter Patients, Cheaper Care?” Business Week, 22 June 2009.  The article is subtitled, “Better-informed medical decisions could cut billions in healthcare costs as patients opt for cheaper treatments.” Once patients understand the small benefit that many treatments confer, they elect not to get them.

See also Laura Landro, “Weighty Choices, in Patients’ Hands,” Wall Street Journal, 04 August 2009: “Studies show that when patients understand their choices and share in the decision-making process with their doctors, they tend to choose less-invasive and less expensive treatments than they would have otherwise received.”

89. Jeanne Lenzer, “Most People Who Take Blood Pressure Medication Possibly Shouldn’t,” Slate, 14 August 2012. The article reports on a study by the Cochrane Collaboration, which is an independent organization.

90. Gina Kolata, “Drug That Stops Bleeding Shows Off-Label Dangers,” New York Times, 18 April 2011.

91. John Carey with Amy Barrett, “Is Heart Surgery Worth It?” Business Week, 18 July 2005. As an example of complications, according to Dr. Nortin Hadler of the University of North Carolina, coronary bypass surgery carries a 1-2 percent risk of death during the surgery and up to a 40 percent chance of permanent mental decline.

92. Steve Connor, “Glaxo Chief: Our Drugs Do Not Work on Most Patients,” Independent (UK), 08 December 2003.

93. Photo credit for four licensed images of faces: ©Mary Jackson | Dreamstime.com, #10866569, licensed and downloaded 27 March 2014.

94. Steve Connor, “Glaxo Chief: Our Drugs Do Not Work on Most Patients,” Independent (UK), 08 December 2003.

See also notes earlier in this chapter which detail other researchers’ agreement with this point. This fact is well known in industry circles; executives typically don’t say so publicly.

95. “Script Your Future” campaign, National Consumers League, scriptyourfuture.org, accessed 29 March 2014.

96. “Taking Medicine Is an Important Part of Staying Healthy,” Aetna Member Essentials, May 2009. This view is representative of the industry.

On a related note, entire businesses focus on helping pharmaceutical companies drive compliance. The website of one of these, Consumer Health Information Corporation, says at http://www.consumer-health.com/services/srv_pharm.php that they have “helped product managers reach goals they never thought possible. Our team of experts develop a patient adherence strategy for the product. The results have led to astounding success for product managers.” It highlights this statement: “Our programs have increased a product’s ROI (return on investment) up to 50 percent.” Note that there is no suggestion that success might be measured in terms of improving patients’ health.

98. Sundeep Khosla, “Increasing Options for the Treatment of Osteoporosis,” New England Journal of Medicine, 12 August 2009.

99. “Your Health: How Do You Score on Taking Your Medicine?” Kiplinger’s Retirement Report, August 2011.

See also Tara Parker-Pope, “Keeping Score on How You Take Your Medicine,” New York Times, 21 June 2011.