Authors: Dr Paul Offit
78
Kessler regarding unsubstantiated claims: Ibid., 92.
78
Food, Drug, Cosmetic, and Device Enforcement Amendments: Ibid., 78.
79
Hutt regarding Kessler: Peter Barton Hutt, interviewed by the author, October 10, 2011.
80
Gerry Kessler vs. the Food, Drug, Cosmetic, and Device Enforcement Amendments: Hurley,
Natural Causes
, 72â103.
80
Orrin Hatch and ties to the supplement industry: Ibid., 75â77.
83
Gerry Kessler and the Dietary Supplement Health and Education Act: Ibid., 72â103.
87
The Snake Oil Protection Act: “The 1993 Snake Oil Protection Act,”
New York Times
, October 5, 1993.
87
Vioxx study in 2000: C. Bombardier, L. Laine, A. Reicin, et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,”
New England Journal of Medicine
343 (2000): 1520â28.
88
Vioxx study in 2005: R. S. Bresalier, R. S. Sandler, H. Quan, et al., “Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial,”
New England Journal of Medicine
352 (2005): 1092â1102.
88
Gilmartin regarding Vioxx withdrawal: J. Kelly, “Vioxx Hearing Raises Questions About What Merck Knew and When,” Medscape, www.medscape.com/viewarticle/538025.
90
Toxic products contained in foods: Food Protection Committee, Food and Nutrition Board, National Academy of Sciences, National Research Council.
Toxicants Occurring Naturally in Foods
. Washington, D. C.: National Academy of Sciences Press, 1966.
90
Singh and Ernst regarding natural vs. unnatural products: Singh and Ernst,
Trick or Treatment
, 222.
90
Harm from herbal products: A. J. Tomassoni and K. Simone, “Herbal Medicines for Children: An Illusion of Safety?”
Current Opinion in Pediatrics
13 (2001): 162â69; A. D. Wolff, “Herbal Remedies and Children: Do They Work? Are They Harmful?”
Pediatrics
112 (2003): 240â46; I. Choonara, “Safety of Herbal Medicines in Children,”
Archives of Diseases of Children
88 (2003): 1032â33; Hurley,
Natural Causes
, 142â43; A. Abdel-Rahman, N. Anyangwe, L. Carlacci, et al., “The Safety and Regulation of Natural Products Used as Foods and Food Ingredients,”
Toxicological Sciences
123 (2011): 333â48.
91
Selenium disaster: T. Tsouderos, “Dietary Supplements: Manufacturing Troubles Widespread, FDA Inspections Show,”
Chicago Tribune
, June 30, 2012.
91
Deaths from herbal products: A. J. Tomassoni and K. Simone, “Herbal Medicines for Children: An Illusion of Safety?”
Current Opinion in Pediatrics
13 (2001): 162â69.
91
Lack of safety testing for dietary supplements: G. Lundberg, “The Wild World of American âSupplements,'”
MedPage Today
, March 5, 2012.
91
Harvard study of ayurvedic remedies: R. B. Saper, S. N. Kales, J. Paquin, et al., “Heavy Metal Content of Ayurvedic Herbal Medicine Products,”
Journal of the
American Medical Association
292 (2005): 2868â73.
91
Deaths from ayurvedic remedies: Ibid.; J. Kew, C. Morris, A. Aihie, et al., “Arsenic and Mercury Intoxication Due to Indian Ethnic Remedies,”
British Medical Journal
306 (1993): 506â507; C. Moore and R. Adler, “Herbal Vitamins: Lead Toxicity and Developmental Delay,”
Pediatrics
106 (2000): 600â602; Centers for Disease Control and Prevention, “Lead Poisoning
Associated with Ayurvedic MedicationsâFive States, 2000â2003,”
Morbidity and Mortality Weekly Report
53 (2004): 582â84.
91
Antimony contamination: T. Tsouderos, “Dietary Supplements.”
91
Harm caused by vitamins and dietary supplements: Hurley,
Natural Causes
, 164; D. M. Marcus and A. P. Grollman, “The Consequences of Ineffective Regulation of Dietary Supplements,”
Archives of Internal Medicine
172 (2012): 1035â36.
92
Harris poll: Ibid., 19.
92
FDA inspects supplement makers: T. Tsouderos, “Dietary Supplements.”
93
Sales of dietary supplements: D. Marcus, “Consumer Reports and Alternative Therapies,”
Science-Based Medicine
blog, http://sciencebasedmedicine.org/index.php/consumer-reports-and-alternative-therapies.
93
Regulation of the supplement industry in Europe: C. Eberhardie, “Nutritional Supplements and the EU: Is Anyone Happy?”
Proceedings of the Nutrition Society
66 (2007): 508â511.
C
HAPTER 4:
F
IFTY-
O
NE
T
HOUSAND
N
EW
S
UPPLEMENTS
95
Herbal remedies: “The Alternative Health Controversy,”
The Dr. Oz Show
, www.doctoroz.com/videos/alternative-health-controversy-pt-1.
95
Rotavirus vaccines: T. Vesikari, D. O. Matson, P. Dennehy, et al., “Safety and Efficacy of a Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine,”
New England Journal of Medicine
354 (2006): 23â33; G. M. Ruiz-Palacios, I. Perez-Schael, F. R. Veláquez, et al., “Safety and Efficacy of an Attenuated Vaccine Against Severe Rotavirus Gastroenteritis,”
New England Journal of Medicine
354 (2006): 11â21.
96
NCCAM studies: T. Tsouderos, “Bad Science, Suspect Medicine,”
Chicago Tribune
, December 11, 2011; E. V. Mielczarek and B. D. Engler, “Measuring Mythology: Startling Concepts in NCCAM Grants,”
Skeptical Inquirer
36 (2012): 35â43.
97
Medawar quote: Singh and Ernst,
Trick or Treatment
, 87 (italics mine).
98
Novella regarding herbal remedies: Steven Novella, “A Skeptic in Oz,”
Neurologica
blog, http://theness.com/neurologicablog/index.php/a-skeptics-in-oz.
99
Ginkgo and dementia: S. T. DeKosky, J. D. Williamson, A. L. Fitzpatrick, et al., “Ginkgo Biloba for Prevention of Dementia: A Randomized Controlled Trial,”
Journal of the American Medical Association
300 (2008):
2253â62; B. Vellas, N. Coley, P.-J. Ousset, et al., “Long-Term Use of Standardised Ginkgo Biloba for the Prevention of Alzheimer's Disease (GuidAge): A Randomised Placebo-Controlled Trial,”
Lancet Neurology
11 (2012): 851â59.
99
St. John's wort and depression: Hypericum Depression Trial Study Group, “Effect of Hypericum Perforatum (St. John's Wort) in Major Depressive Disorder: A Randomized, Controlled Trial,”
Journal of the American Medical Association
287 (2002): 1807â14.
100
Garlic and cholesterol: C. D. Gardner, L. D. Lawson, E. Block, et al., “Effect of Raw Garlic Vs. Commercial Garlic Supplements on Plasma Lipid Concentrations in Adults with Moderate Hypercholesterolemia,”
Archives of Internal Medicine
167 (2007): 346â53.
101
Saw palmetto and prostate enlargement: S. Bent, C. Kane, K. Shinohara, et al., “Saw Palmetto for Benign Prostatic Hyperplasia,”
New England Journal of Medicine
354 (2006): 557â66.
101
Second study of saw palmetto: K. J. Kreder, A. L. Avins, D. Nickel, et al., “Effect of Increasing Doses of Saw Palmetto Extract on Lower Urinary Tract Symptoms,”
Journal of the American Medical Association
306 (2011): 1344â51; D. W. Freeman, “Saw Palmetto No Help for Enlarged Prostate, Study Says,” CBS News, September 28, 2011.
102
Milk thistle for hepatitis: M. Freed, “A Randomized, Placebo-Controlled Trial of Oral Silymarin (Milk Thistle) for Chronic Hepatitis C: Final Results of the SYNCH Multicenter Study,” presented November 8, 2011, at the American Association for the Study of Liver Diseases annual meeting in San Francisco.
102
Chondroitin sulfate and glucosamine for arthritis: D. O. Clegg, D. J. Reda, C. I. Harris, et al., “Glucosamine, Chondroitin Sulfate, and the Two in Combination for Painful Knee Osteoarthritis,”
New England Journal of Medicine
354 (2006): 795â808.
103
Echinacea for colds: J. A. Taylor, W. Weber, L. Standish, et al., “Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children,”
Journal of the American Medical Association
290 (2003): 2824â30.
103
Number of dietary supplements on the market: A. Abdel-Rahman, N. Anyangwe, L. Carlacci, et al., “The Safety and Regulation of Natural Products Used as Foods and Food Ingredients,”
Toxicological Sciences
123 (2011): 333â48; P. A. Cohen, “Assessing Supplement SafetyâThe FDA's Controversial Proposal,”
New England Journal of Medicine
366 (2012): 389â91.
103
Benefits of supplements: Hurley,
Natural Causes
, 260â61.
103
Omega-3 fatty acids: P. M. Kris-Etherton, W. S. Harris, L. J. Appel for the Nutrition Committee, “Fish Consumption, Fish Oil, Omega-3 Fatty Acids, and Cardiovascular Disease,”
Circulation
106 (2002): 2747â57; E. C. Rizos, E. E. Nitzani, E. Bika, et al., “Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events: A Systematic Review and Meta-Analysis,”
Journal of the American Medical Association
308 (2012): 1024â33.
104
Calcium: “Calcium Supplements: Risks and Benefits,” Medscape, www.medscape.com/viewarticle/497826_print; “Dietary Supplement Fact Sheet: Calcium,” National Institutes of Health, http://ods.od.nih.gov/factsheets/calcium-healthprofessional; Mayo Clinic Staff, “Calcium and Calcium Supplements: Achieving the Right Balance,” Mayo Clinic, http://www.mayoclinic.com/health/calcium-supplements/MY01540; G. Kolata, “Healthy Women Advised Not to Take Calcium and Vitamin D to Prevent Fractures,”
New York Times
, June 12, 2012.
105
Vitamin D: “Dietary Supplement Fact Sheet: Vitamin D,” National Institutes of Health, http://ods.od.nih.gov/factsheets/VitaminD-QuickFacts; “Vitamin D,” Mayo Clinic, http://www.mayoclinic.com/health/vitamind/NS_patient-vitamind; “Find a Vitamin or Supplement: Vitamin D,” WebMD; “What Is Vitamin D? What Are the Benefits of Vitamin D?”
Medical News Today
; Kolata, “Healthy Women Advised”; H. A. Bischoff-Ferrari, W. C. Willett, E. J. Oray, et al., “A Pooled Analysis of Vitamin D Dose Requirements for Fracture Prevention,”
New England Journal of Medicine
367 (2012): 40â49; R. P. Heaney, “Vitamin DâBaseline Status and Effective Dose,”
New England Journal of Medicine
367 (2012): 77â78.
105
Folic acid: “Dietary Supplement Fact Sheet: Folate,” http://ods.od.nig.gov/factsheets/Folate-HealthProfessional; “Find a Vitamin or Supplement: Folic Acid,” WebMD; “Folic Acid,” www.womenshealth.gov; Centers for Disease Control and Prevention, “Folic Acid Recommendations,” www.cdc.gov/ ncbddd/folicacid/recommendations/html.
C
HAPTER 5:
M
ENOPAUSE AND
A
GING
111
Celebrities offer medical advice: John Stossel, Fox Business Network, February 24, 2011; Singh and Ernst,
Trick or Treatment
, 251.
113
Somers on Larry King Live:
Larry King Live
, October 14, 2006.
113
Somers and Mack truck:
The Oprah Winfrey Show
, January 29, 2009.
113
Christiane Northrup on menopause:
The Oprah Winfrey Show
, January 15, 2009.
113
The Seven Dwarfs of Menopause: S. Somers,
The Sexy Years: Discover the Hormone Connection: The Secret to Fabulous Sex, Great Health, and Vitality, for Women and Men
(New York: Three Rivers Press, 2004), 2.
114
Somers finds the answer to menopause: S. Somers,
Ageless: The Naked Truth About Bioidentical Hormones
(New York: Three Rivers Press, 2006), 5.
114
O'Donnell on CNN:
The Joy Behar Show
, February 17, 2011.
115
Oprah and bioidentical hormones: W. Kosova, “Live Your Best Life Ever!”
Newsweek
, May 30, 2009.
115
2002 Women's Health Initiative study: J. E. Rossouw, G. L. Anderson, R. L. Prentice, et al., “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results from the Women's Health Initiative Randomized Controlled Trial,”
Journal of the American Medical Association
288 (2002): 321â33.
115
Somers sends the dwarfs packing: Somers,
Sexy Years
, 4.
116
Streicher regarding chemical structures:
The Oprah Winfrey Show
, January 29, 2009.
116
Schwarcz regarding natural substances: J. Schwarcz,
The Fly in the Ointment: 70 Fascinating Commentaries on the Science of Everyday Food & Life
(Toronto: ECW Press, 2004), 129.
116
Streicher regarding hormone manufacture:
The Oprah Winfrey Show
, January 29, 2009.
117
Utian and the Tooth Fairy:
The Oprah Winfrey Show
, January 15, 2009.
117
Streicher and dangerous perceptions:
The Oprah Winfrey Show
, January 29, 2009.
117
Unreliability of compounding pharmacies: American College of Obstetrics and Gynecology, “No Scientific Evidence Supporting Effectiveness or Safety of Compounded Bioidentical Hormone Therapy,” press release, October 31, 2005.
118
Somers regarding hormones and aging: Somers,
Ageless
, xxiii.
118
Somers on hormones as anti-aging medicine: Ibid., 12â14.
118
Somers's anti-aging regimen: Somers,
Sexy Years
, 297; Somers,
Ageless
, 317; Somers,
Sexy Forever
, 130, 139; Somers,
Breakthrough: Eight Steps to Wellness: Life-Altering Secrets from Today's Cutting-Edge Doctors
(New York: Three Rivers Press, 2008), 66â70;
The Oprah Winfrey Show
, January 29, 2009.