The hCG Hoax Kenneth N. Woliner, M.D., A.B.F.M. Holistic Family Medicine, LLC Boca Raton, FL 561-620-7779 www.holisticfamilymed.com knw6@cornell.edu

Kenneth Woliner, MD, ABFM B.S. (Nutrition) – Cornell University M.D. – University of South Florida Board-certified, Family Medicine West Boca Medical Center – CME committee Palm Beach Co. Med. Soc. – Board of Directors Institute of Functional Medicine – faculty Conflicts of Interest – none to report

Objectives What is the hCG Diet? What is the history of the hCG Diet? Claims of hCG: what are they? What is the “starvation response”? Is it legal? Consequences of hCG dieting? What should dietitians do about hCG?

What dieters see on the Internet

hCG Diet Components 500 kcal / day diet, skipping breakfast Injections of a prescription drug, 125 units hCG, 6d/wk*^ A “ritual” to specifically follow “gorging” x 3 days 2 meals per day with only “apples” as snacks daily weight checks no cosmetics no exercise Limited to 26 – 40 days max, per cycle Gap of at least 6 weeks per cycle A “stiff fee”, paid by dieter *125 iu/dose chosen because Simeons purchased 5,000 iu vials and Simeons wanted the vial to last for 40 doses. 1 day off because clinic (in Rome) was not open on Sundays. Asher WL. hCG: a debate. American Society of Bariatric Physicians. New Orleans 2010: Obesity & Associated Conditions Course: hCG: A Debate ^HCG injections forced patients to come in weekly (or stay in his hospital), assuring proprietors of diet clinics a “steady income” www.dietscam.org

hCG Diet Claims “HCG mobilizes 2000 – 3000 calories from your stored fat.” “Resets your hypothalamus!” “Fat burning and lean muscle sparing.” “Redistributes stored fat from waist, hips, thighs to your face.” “Decreases appetite.” “Maintaining weight loss after returning to normal dietary intake.” “Ends the cycle of yo-yo dieting results.” “Clears skin, tightens skin, strengthens brittle nails, cures headaches” Schatz DL. How to lose weight? A multiple choice question for the patient. Can Fam Physician. 1975 Apr;21(4):87-8. PMID: 20469186

hCG Diet = FAD DIET

Fad Diet Definition Promises of rapid weight loss Elements of ritual and sacrifice Magical food or food combination Unlimited foods of some type Rigid menus or monotonous food choices Jargon and scientific half-truths Lack of good scientific evidence Lack of acknowledgement of physical activity needs Roberts DC. Quick weight loss: sorting fad from fact. Med J Aust. 2001 Dec 3-17;175(11-12):637-40. PMID: 11837873.

Why even think hCG? hCG = Human Chorionic Gonadotropin Chorionic gonadotropin can be “animal source”, or “human source” Produced in high amounts by the human placenta “Turns the stick blue” – on a pregnancy test Also produced elsewhere (by the pituitary gland) Stimulates testosterone production (men) estrogen production, ovulation (women)

Froehlich’s Syndrome 13 yr old tall fat boy 64½ in, 160 lbs, BMI 27 Small genitals No sexual hair Fairly wide pelvis Enlarged breasts with wide areola Fat face and trunk Slender limbs Simpson SL. Adipose gynandrism and gynism. Proc R Soc Med. 1951 Jun; 44(6):453-9. PMID: 14864525

Why even think hCG? 1924 – George Abbott, MD describes: adiposity, scanty menstruation/amenorrhea, headache, fatigue, large tonsils. Similar to children with pituitary insufficiency? Treatment with pituitary extract resolve headache and fatigue, but only mild improvement in obesity and menstrual periods. Abbott GK. The adult equivalent of Froehlich Syndrome. Cal State J Med. 1924 Jan;22(1):20-1. PMID: 18739184

Why even think hCG? 1946 – Chorionic gonadotropin first used to treat Frohlich’s Syndrome Chorionic gonadotropin can reverse the “estrogenic fat distribution” that occurs with lack of testosterone Luft R. Chorionic gonadotrophin in the treatment of disturbances of development in childhood and adolescence; preliminary report. Acta Paediatr. 1946 Dec 30;33(3-4):211-29. PMID: 20254629 Knowlton K, Kenyon AT. The metabolic response to chorionic gonadotropin stimulation in young men. J Clin Endocrinol Metab. 1948 Jul;8(7):600. PubMed PMID: 18869622

Why even think hCG? 1951 - S. Levy Simpson, MD describes: Adiposity (waist, hips, thighs), sparing limbs Males: feminine appearance (gynecomastia, small phallus, lack male hair growth pattern) Female: early menstruation, big breasts, big areola “Pituitary insufficiency” described as a possible cause Simpson SL. Adipose gynandrism and gynism. Proc R Soc Med. 1951 Jun;44(6):453-9. PMID: 14864525

Why even think hCG? hCG became “popular” in the 1940’s and 1950’s hCG drugs became commercially available Used to low testosterone, hemorrhagic ovarian cysts, menstrual problems, infertility, stomach ulcers, acne, psoriasis, bedwetting in children, etc. Dailey ME, Benefiel WW. An evaluation of kutrol in the treatment of uncomplicated duodenal ulcer. Gastroenterology. 1953 Aug;24(4):535-9. PMID: 13083814 Treatment of acne vulgaris and of acne rosacea. Postgrad Med. 1953 Feb;13(2):A-18-20. PMID: 13037549 Burdick HO, Crump M. The effect of induced ovulation on pregnancy. Endocrinology. 1951 Mar;48(3):273-6. 14822936 Cioffari MS, Clark HG. The treatment of enuresis in children by means of chorionic gonadotropin. Arch Pediatr. 1947 Feb;64(2):61-4. PMID: 20288690 Luft R. Chorionic gonadotrophin in the treatment of disturbances of development in childhood and adolescence; preliminary report. Acta Paediatr. 1946 Dec 30;33(3-4):211-29. PMID: 20254629 Landrau RL, Knowlton K, Lugibihl K, Brandt M, Kenyon AT. The anabolic effects of chorionic gonadotropin in normal young men. J Clin Invest. 1950 May;29(5):619-29. PubMed PMID: 15415466; PubMed Central PMCID: PMC436099.

Albert T.W. Simeons, MD

Albert T.W. Simeons, MD

Albert T.W. Simeons, MD 1954 – Lancet – first report on hCG diet Publishes a “case series” of patients whom he treated for obesity with hCG This was not a “study”. Patients were “cherry picked”. Any patient who did not lose weight Branded by Simeons as “Liars and Fools” Simeons “refused further treatment” 1954 – “Pounds and Inches” – self-published book on hCG No publisher accepted manuscript (even though it was a diet book) 1957 – “Harper’s Bazaar” – gains world-wide popularity Hallmark of fad diets – bypass the peer-reviewed literature 1970 – Simeons dies at age 70. Simeons AT. The action of chorionic gonadotrophin in the obese. Lancet. 1954 Nov 6;267(6845):946-7. PMID: 13213083 Simeons ATW. Pounds and Inches: A new approach to obesity. Rome, privately printed. 1954. Simeons ATW. Slimming: A Roman Doctor’s Treatment. Harper’s Bazaar. 1957 Oct;2951:136-137, 226, 228.

History of hCG Diet 3 main phases: 1949 – 1970 – “Simeons years” Original “case reports” report benefit Randomized studies debunk hCG Diet 1973 – 1995 – “hCG comes to the U.S.A.” Mass commercialization of hCG diet Side effects mount Criticism of hCG diet becomes intense 2007 – present – “History repeats itself” Kevin Trudeau Oral hCG Compounding pharmacies tout “hCG diet” to doctors as a “cash cow”

hCG Diet: Simeons years (1949 – 1970) 1949 – Albert T.W. Simeons, MD moves to Rome and sets up obesity clinic using hCG 1954 – Lancet article published - little notice given. 1954 – “Pounds and Inches” self-published - still, little notice given. 1956 – Simeons publishes “opinion” article describing hCG protocol in American Journal of Geriatrics – still little notice given. 1957 – Harper’s Bazaar article published – social elite, Hollywood starlets fly to Italy for treatment. Simeons AT. Chorionic gonadotropin in geriatrics. J Am Geriatr Soc. 1956 Jan;4(1):36-40. PMID: 13286062

hCG Diet: Simeons years (1949 – 1970) 1959 – Mario Lanza, “The Great Caruso”, dies at age thirty-eight (38), as a consequence of crash dieting (including the use of hCG) Cesari A, Mackowiak PA. A fatal zest for living. The all too brief life of Mario Lanza. Pharos Alpha Omega Alpha Honor Med Soc. 2010 Winter;73(1):4-10. PMID: 20180289

hCG Diet: Simeons years (1949 – 1970) Other doctors try to replicate results 1959 – Ezra Sohar, MD (Tel-Aviv, Israel) Non-randomized controlled trial (NCT) 550 Calorie Diet x 40 days 39 patients – 125 units hCG, 14 patients – placebo Both groups lost weight equally (non-significant difference) Saline = 234.3 gm/d (3.61 lbs/week) hCG = 239.2 gm/d (3.69 lbs/week) Patients “felt hungry during the first few days of the diet; later hunger was not very strong, but a certain weakness took its place” “Most patients were constipated throughout the course of the diet.” Sohar E. A forty-day-550 calorie diet in the treatment of obese outpatients. Am J Clin Nutr. 1959 Sep-Oct;7:514-8. PMID: 13832483

hCG Diet: Simeons years (1949 – 1970) Non-randomized controlled trials (NCTs) Sohar (1959) – negative Lebon (1966) – positive* Hastrup (1960) – negative Gusman (1969) – negative Harris (1964) – negative Randomized controlled trials (RCTs) Craig (1963) – negative Frank (1964) – negative Carne (1961) – negative * investigator not blinded, poor follow-up Lebon P. Treatment of overweight patients with chorionic gonadotropin: follow-up study. J Am Geriat Soc 1966;14:116-25. Lijesen GK, et al. The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis. Br J Clin Pharmacol. 1995 Sep;40(3):237-43. PMID: 8527285

hCG Diet: Simeons years (1949 – 1970) Criticism: “Weight loss with the Simeons’ regimen was in no way related to hCG.” (Sohar) “Average loss of 6.5 pounds in treated subjects and 8.8 pounds in control subjects … diet, rather than the action of hCG, is the important factor in Simeons’ program.” (Craig) “Simeons’ 500 calorie diet [does not] teach the patient new habits of eating. … [Simeons] presents no data concerning blood fat studies, [etc.] which would support his hypothesis [regarding hCG].” (Frank) Sohar E. A forty-day-550 calorie diet in the treatment of obese outpatients. Am J Clin Nutr. 1959 Sep-Oct;7:514-8. PMID: 13832483 Craig LS, et al. Chorionic gonadotropin in the treatment of obese women. Am J Clin Nutr. 1963 Mar;12:230-4. PMID: 14023631 Frank BW. The use of chorionic gonadotropin hormone in the treatment of obesity. A double-blind study. Am J Clin Nutr. 1964 Mar;14:133-6. PMID: 14127942.

hCG Diet: Simeons years (1949 – 1970) Criticism: “[Simeons] states that following the use of HCG in the non-pregnant state, a person’s ‘blood is always saturated with food regardless of how little he or she may eat.’ It should be emphasized that there is no scientific support for this contention.” “The Dept. of Drugs of the American Medical Association finds no scientific evidence from controlled experiments to justify the use of human chorionic gonadotropin in the treatment of obesity.” McGanity WJ. Weight Reduction-Facts and Fancy. JAMA. 1982 Dec 15;182(11):1141-2.

hCG Diet: Simeons years (1949 – 1970) “A good scientific theory is not only one that works …; it is one which can be subjected to disproof.” “It is only the hazard of refutation, the susceptibility to disproof which distinguishes a scientifically powerful and useful hypothesis from a scientifically useless one.” “The evidence … is not convincing.” “While many possible effects of HCG on obesity might be entertained, at the moment the burden of proof that it does anything at all is on the shoulders of its proponents.” Albrink MJ. Chorionic gonadotropin and obesity? Am J Clin Nutr. 1969 Jun;22(6):681-5. PubMed PMID: 5789466

hCG Diet in the U.S.A. (1973 - 1995) March 5, 1973 - hCG gets U.S. FDA approval Prepubertal cryptorchidism (undescended testicle) Hypogonadism secondary to a pituitary deficiency, in males. Induction of ovulation and pregnancy in the anovulatory, infertile woman NOT APPROVED FOR WEIGHT CONTROL Note well: prior to 1973 – many doctors were (illegally) using hCG, even though this drug was not yet approved by the FDA . Gusman HA. Chorionic gonadotropin in obesity. Further clinical observations. Am J Clin Nutr. 1969 Jun;22(6):686-95. PMID: 5789467

hCG Diet in the U.S.A. (1973 - 1995) Diet clinics spring up (starting in California, then the rest of the U.S.) 1971 - First chain operation called “Medical Slenderizing” opens up in San Diego with offices throughout California Many clinics owned by “corporations” that employ doctors to “sign off” on prescriptions, even though they don’t see the patients. Dentist Jack Free cancels opening of diet clinics after Michigan Attorney General, Frank Kelley notifies him he would be prosecuted. Mississippi Attorney General forces hCG clinics to display signs with two-inch letters saying that hCG injections could be dangerous. California Attorney General files lawsuits charging “unlicensed practice of medicine.” Ballin JC, White PL. Fallacy and hazard. Human chorionic gonadotropin-500-calorie diet and weight reduction. JAMA. 1974 Nov4;230(5):693-4. PMID: 4479126 Holles ER. ‘Fat Clinics’ Challenged on Use of Drug. NY Times. Sept 26, 1974.

Oakland Tribune, June 16, 1974

San Francisco Chronicle June 11, 1974

San Francisco Examiner & Chronicle – June 23, 1974

San Francisco Examiner June 19, 1974

hCG: common side effects Hunger (first 3 days) Severe headaches (first week) Constipation (throughout entire diet) Fatigue (throughout entire diet) Delayed onset of menses (when on diet) Hair loss (occurring 1-3 months after crash diet) Muscle wasting and weakness (throughout) Lowered metabolic rate, making it likely to regain weight Stein MR, et al. Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study. Am J Clin Nutr. 1976 Sep;29(9):940-8. PMID: 786001 Krusinski PA. Letter: Telogen effluvium secondary to weight loss and therapy with chorionic gonadotropin. Arch Dermatol. 1976 Apr;112(4):556. PMID: 1267466

hCG: serious side effects Gallstones, leading to a cholecystectomy Stein MR, et al. Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study. Am J Clin Nutr. 1976 Sep;29(9):940-8. PMID: 786001 Ovarian hyperstimulation syndrome leading to total hysterectomy Dunn CE. Letter: Human chorionic gonadotropin for weight reduction. Am J Obstet Gynecol. 1974 Nov 15;120(6):855. PubMed PMID: 4429101. Hair loss Goette DK, Odom RB. Alopecia in crash dieters. JAMA. 1976 Jun 14;235(24):2622-3. PMID: 946869 Trozak DJ. Letter: Hair loss after therapy with chorionic gonadotropin. Arch Dermatol. 1976 Jul;112(7):1035. PMID: 938071

hCG: serious side effects Fatal Cardiomyopathy Lovel TW, Porter GD. Cardiomyopathy after gonadotrophin treatment. Br Med J. 1977 Feb 19;1(6059):511. PubMed PMID: 837187 Hip fracture in teenagers Hirsch PJ, Hirsch SA. Slipped capital femoral epiphysis. Occurrence after treatment with chorionic gonadotropin. JAMA. 1976 Feb 16;235(7):751. PMID: 946296 Hepatitis outbreaks Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan JM. An outbreak of hepatitis B associated with jet injections in a weight reduction clinic. Arch Intern Med. 1990 Sep;150(9):1923-7. PMID: 2393323. Centers for Disease Control (CDC). Hepatitis B associated with jet gun injection--California. MMWR Morb Mortal Wkly Rep. 1986 Jun 13;35(23):373-6. PMID: 3086694. Birth Defects and Miscarriage (Pregnancy Class X) Banik UK. Pregnancy-terminating effect of human chorionic gonadotrophin in rats. J Reprod Fertil. 1975 Jan;42(1):67-76. PMID: 1110475

hCG Diet in the U.S.A. (1973 - 1995) Diet clinics falsely advertised hCG as being useful for weight loss. Many clinics owned by “corporations” that employ doctors to “sign off” on prescriptions, even though they don’t see the patients. Advertisements for “Simeons Method” and “hCG Diet” cause FDA to declare “hCG to be a ‘new drug’ when advertised for the purpose of weight control” and changes labeling to say, in ALL CAPS: HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION. HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Federal Register. Dec 5, 1974. (CX6; 39 F.R. 234, pp. 42397-42403)

hCG Diet in the U.S.A. (1973 - 1995) Oct 15, 1974 – Federal Trade Commission (FTC) sues diet clinics for “false advertising” violating the Federal Trade Commission and Federal Food, Drug and Cosmetic Acts Misbranding a legend drug by advertising it for a purpose not approved by the U.S. FDA. “It is a false, unfair, and deceptive practice in violation of Sections 5 and 12 of the Federal Trade Commission Act to fail to disclose, in an advertisement relating to treatment programs of weight reduction clinics which employ prescription drugs not approved for weight reduction by the Food and Drug Administration, that such treatment programs involve the use of a prescription drug not approved by the FDA for weight reduction purposes. Weight Reduction Products and Plans. Hearings before the Permanent Subcommittee on Investigations of the Committee on Governmental Affairs. U.S. Senate. Ninety-Ninth Congress, 1st Session. May 14-15, 1985. S. Hrg 99-228.

AP News Service. Disclaimer Ordered on Drug Used in Antifat Clinics AP News Service. Disclaimer Ordered on Drug Used in Antifat Clinics. NY Times. Dec 15, 1974

hCG Diet in the U.S.A. (1973 - 1995) Jun 18, 1975 – Diet clinics lose. Ordered to stop advertising without each and every ad to include the words (in 10-pt ALL CAPS): THESE WEIGHT REDUCTION TREATMENTS INCLUDE THE INJECTION OF HCG, A DRUG WHICH HAS NOT BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION AS SAFE AND EFFECTIVE IN THE TREATMENT OF OBESITY OR WEIGHT CONTROL. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG INCEASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTIVE DIETS. Federal Trade Commission Decisions. Complaint in the matter of Simeon Management Corporation et al. Order, opinion etc., in regard to alleged violation of Secs. 5 and 12 of the Federal Trade Commission Act. Docket 8996. Complaint, Oct 15, 1974. Final Order April 29, 1976. http://www.ftc.gov/os/decisions/docs/vol87/FTC_VOLUME_DECISION_87_(JANUARY_-_JUNE_1976)PAGES_1184-1278.pdf Apr 29, 1976 – Affirmed on appeal. Jul 18, 1978 – Final appeal fails. Simeon Management Corp., et al., 87 FTC 1184, 1230-1 (1976) aff’d 579 F.2d 1137 (9th Cir. 1978).

hCG Diet in the U.S.A. (1973 - 1995) More Randomized Trials Veilleux (1972) – negative Asher (1973) – positive * Asher (1973) – negative** Stein (1976) – negative Greenway (1977) – negative Shetty (1977) – negative Miller (1977) – negative Richter (1984) – negative Mems (1986) – negative Bosch (1990) – negative * high amount of dropouts in “placebo group”, so they got less injections, blinding failed as nurse giving shots identified which patients were getting hCG vs. placebo (personal communication with Asher, 2011). ** Asher described in his 1973 article a multi-site double-blind study with 4 clinical sites which revealed negative results  so not published on its own. Asher WL, Harper HW. Effect of human chorionic gonadotrophin on weight loss, hunger, and feeling of well-being. Am J Clin Nutr. 1973 Feb;26(2):211-8. PMID: 4574032

hCG Diet in the U.S.A. (1973 - 1995) Letter describing flaws in Asher’s “positive” study: “It makes little difference what the injection is … individuals who receive more injections may adhere better to a low calorie diet than those who do not.” (Van Itallie) Van Itallie TB, Hirsch J. Letter: The treatment of obesity. Am J Clin Nutr. 1973 Oct;26(10):1039-41. PMID: 4754660

History of hCG Diet (1973 - 1995) Criticism “On a 500-calorie diet, protein and mineral losses are extensive. … The Simeons diet would thus appear to be inadequate in protein to prevent negative nitrogen balance.” (Ballin) “The physiological analogy [between obesity and Frohlich’s Syndrome] is far-fetched indeed.” (Schatz) Ballin JC, White PL. Fallacy and hazard. Human chorionicgonadotropin-500-calorie diet and weight reduction. JAMA. 1974 Nov4;230(5):693-4. PMID: 4479126 Schatz DL. How to lose weight? A multiple choice question for the patient. Can Fam Physician. 1975 Apr;21(4):87-8. PMID: 20469186

hCG Diet in the U.S.A. (1973 - 1995) More criticism of “hCG diet” Health information in the mass media: the case of chorionic gonadotropin and obesity. Med J Aust. 1973 Feb 17;1(7):321-2. PMID: 4699022 De Kretser DM. Health information in the mass media: the case of chorionic gonadotropin and obesity. Med J Aust. 1973 Mar 3;1(9):462. PMID: 4736176 Van Itallie TB, Hirsch J. Letter: The treatment of obesity. Am J Clin Nutr. 1973 Oct;26(10):1039-41. PMID: 4754660 Maudlin RK. Gonadotropins in obesity? Am Fam Physician. 1973 Oct;8(4):202-3. PMID: 4793101 Rath R, Vondra K. [Use of choriogonadotropin in the treatment of obesity]. Vnitr Lek. 1974 Jul;20(7):681-5. PMID: 4845982

hCG Diet in the U.S.A. (1973 - 1995) More criticism of “hCG diet” Nutritional misinformation therapy of unproved usefulness in obesity. Nutr Rev. 1974 Oct;32(10):316. PMID: 4414864 Ballin JC, White PL. Fallacy and hazard. Human chorionicgonadotropin-500-calorie diet and weight reduction. JAMA. 1974 Nov4;230(5):693-4. PMID: 4479126 Rivlin RS. The use of hormones in the treatment of obesity. Curr Concepts Nutr. 1975;3:151-62. Review. PMID: 1093810 Rivlin RS. Therapy of obesity with hormones. N Engl J Med. 1975 Jan 2;292(1):26-9. PubMed PMID: 1109187 Editorial: Obesity and HCG. Del Med J. 1975 Mar;47(3):140-1. PMID:1116637

History of hCG Diet (1973 - 1995) More criticism of “hCG diet” Letter: Hormonal actions and obesity. N Engl J Med. 1975 Mar20;292(12):647-8. PMID: 1113751 HCG not approved for use in obesity. Behav Neuropsychiatry. 1975 Apr-1976 Mar;7(1-12):4. PMID: 1235847 Faludi G. Use of chorionic gonadotropins in obesity. Am Fam Physician. 1975 May;11(5):156-7. PMID: 1130251 Coote WJ. Letter: Human chorionic gonadotrophin. Med J Aust. 1975 Jul 26;2(4):151-2. PMID: 1160751 Bray GA, Greenway FL. Pharmacological approaches to treating the obese patient. Clin Endocrinol Metab. 1976 Jul;5(2):455-79. Review. PMID: 821680

History of hCG Diet (1973 - 1995) More criticism: Perelberg H. Chorionic gonadotrophin (HCG) and obesity. Med J Aust. 1977 Jul 9;2(2):68-9. PMID: 331044 Berger M, et al. [Is HCG therapy obesity warranted?]. Med Klin. 1980 Aug 15;75(17):624-5. Review. PMID: 6997717 Birmingham CL, Smith KC. Human chorionic gonadotropin is of no value in the management of obesity. Can Med Assoc J. 1983 May 15;128(10):1156-7. PMID: 6340811 Blackburn GL, Pavlou K. Fad reducing diets: separating fads from facts. Bol Asoc Med P R. 1984 Aug;76(8):349-51. PMID: 6593075 Rabe T, Richter S, Kiesel L, Runnebaum B. [Risk-benefit analysis of a hCG-500 kcal reducing diet (cura romana) in females]. Geburtshilfe Frauenheilkd. 1987 May;47(5):297-307. PMID: 3609673

hCG Diet in the U.S.A. (1973 - 1995) 1995 - Meta-analysis “We conclude that there is no scientific evidence that HCG causes weight-loss, a redistribution of fat, staves off hunger or induces a feeling of well-being. Therefore, the use of HCG should be regarded as an inappropriate therapy for weight reduction … Pharmacists and physicians should be alert on the use of HCG for Simeons therapy. The results of this meta-analysis supports a firm standpoint against this improper indication. Restraints on physicians practicing this therapy can be based on our findings.” Lijesen GK, et al. The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis. Br J Clin Pharmacol. 1995 Sep;40(3):237-43. PMID: 8527285

hCG: recent journal articles Wansink B; American Dietetic Association. Position of the American Dietetic Association: food and nutrition misinformation. J Am Diet Assoc. 2006 Apr;106(4):601-7. PMID: 16639825 Robb-Nicholson C. By the way, doctor. I've been trying to lose weight for a long time and nothing seems to work. What do you know about the HCG diet? Harv Womens Health Watch. 2010 May;17(9):8. PMID: 20593560 Cunningham E. Where can I find information on the use of human chorionic gonadotrophin (HCG) for weight loss? J Am Diet Assoc. 2010 Dec;110(12):1960. PMID: 21111102. Toffle RC. "There they go again"--hCG and weight loss. W V Med J. 2011 Jan-Feb;107(1):12-3. PMID: 21322466 In Brief: human chorionic gonadotropin (hGC) for weight loss. Med Lett Drugs Ther. 2011 Feb 21;53(1358):16. PMID: 21372763 Lovejoy JC, Sasagawa M. An unfortunate resurgence of human chorionic gonadotropin use for weight loss. Int J Obes (Lond). 2011 Oct 4. PMID: 21968760 Yen M, Ewald MB. Toxicity of Weight Loss Agents. J Med Toxicol. 2012 Feb 14. PMID: 22351299

hCG: History repeats (2007 – present) 1999 – Daniel Belluscio, MD describes “oral hCG” 2007 – Kevin Trudeau publishes “The Weight Loss Cure ‘They’ Don't Want You to Know About” 2007 – Compounding pharmacies tout “hCG” as a “cash cow”. Offer routes of administration: subcutaneous, oral, sublingual, topical, and “injectable pellets” 2009 – chiropractors, acupuncturists and unlicensed “health coaches” get into the hCG biz 2009 – “fake” OTC hCG products flood vitamin stores and the Internet

Oral hCG *Opti-lean is an illegal oral hCG product manufactured by “Drug Depot Inc” d.b.a. “APS Pharmacy” (Florida Pharmacy License: PH20986), distributed by Joe Jeldy , a former advertising salesperson who now is in the weight loss business. Drug Depot has previously been disciplined by the Florida Board of Pharmacy (DOH Case No.: 200816712) for wholesaling drugs without a permit (among other violations).

Oral hCG 1999 – Daniel Beluscio writes an article regarding hCG in an oral form. It is refused publication in any PubMed refereed journal, and instead, is published on his website: http://www.hcgobesity.org/hcg_obesity.pdf hCG doesn’t get absorbed through sublingual, bucal, oral, or GI routes because it is too big in size. hCG is composed of 237 amino acids and has a mass of 36,700 daltons. The maximum size for “sublingual absorption” of a peptide hormone is only 300 daltons. (Intranasal dosing can be up to 2,000 daltons) In comparison, Insulin has 51 amino acids and weighs only 5,700 daltons. ORAL HCG IS NOT ABSORBED! Dr. Beluscio admits, “oral hCG cannot be detected in plasma” http://hcgdietinfo.com/hcgdietforums/f6/oh-no-i-already-mixed-sublingual-solution-now-i-read-about-dalton-size-ugh-46510/index2.html Tang L and Meibohm M. “Pharmacokinetics of peptides and proteins” in Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development (Bernd Meibohm, Editor). 2007. Wiley-VCH. Weinheim, Germany. ISBN-13: 978-3527314089. pps. 17-44.

Oral hCG Supposedly, patients using “oral compounded hCG” showed more weight loss than a group of patients using just meal replacements. Flaws in study Retrospective chart review (rather than a randomized, double-blind prospective study) – not blinded at all, high placebo response Groups sufficiently different – non-hCG group was less compliant with meal replacements and follow up visits. Only 19 patients in each group – lacks power to prevent a “type 1 error” “Opti-lean” oral hCG is an “illegal product” as compounding pharmacies are not allowed to “manufacture drugs” and distribute them to physicians’ offices for further dispensing. “The Bariatrician” is not a peer-reviewed journal. It is a trade group magazine, edited by a physician who falsely claims to be “board-certified” by the American Board of Family Medicine, when he is not. Bryman, DA. Successful weight loss intervention using a modified hCG Diet. A retrospective six week analysis. The Bariatrician. 2010;25(2):9-11. (not indexed in PubMed) www.theabfm.org search for “Gerald Michael Steelman”. Accessed 12/5/2011.

Oral hCG doesn’t work Dr. Bryman NO LONGER USES hCG AT ALL, as he has found it to be totally ineffective at reducing appetite, helping weight loss, or selective loss of fat. “I only studied 19 patients then stopped using any form of hcg as i found it ineffective after weight loss initially. Feel free to call if you have any questions. I don’t know the company or owners. I stand by asbp in our position regarding hcg.” Bryman DA. Question about Opti-Lean. E-mail to Ken Woliner, July 8, 2011.

ASBP Position on hCG It is the position of the American Society of Bariatric Physicians that: The Simeons method for weight loss is not recommended. The Simeons diet is not recommended. The use of HCG for weight loss is not recommended. “Physicians employing either the HCG or the diet recommended by Simeons may expose themselves to criticism from other physicians, from insurers, or from government bodies.” American Society of Bariatric Physicians (ASBP) Position on use of hCG in the treatment of obesity. Approved by ASBP Board of Directors, December 2009. ASBP News. 2010 Jan/Feb. 8-9.

Kevin Trudeau “Misleading commercial speech is entitled to no first amendment protection.” FTC. Judge Orders Kevin Trudeau to Pay More Than $37 Million for False Claims About Weight-Loss Book. 2009 Jan 19. http://www.ftc.gov/opa/2009/01/trudeau.shtm

Kevin Trudeau Two-time convicted felon “One-heck of a salesman” Banned for life from selling products on TV (with the exception that he could talk about books due to 1st Amendment protections. Started “writing books” and making false claims about them. FTC sued for misleading commercial speech, judgment of $37.6 million (affirmed on appeal Nov 29, 2011) http://en.wikipedia.org/wiki/Kevin_Trudeau FTC v. Trudeau 662 F.3d 947 (2011) No. 10-2418. U.S. Court of Appeals, 7th Circuit. Nov 29, 2011.

Compounding pharmacies FDA approved hCG is only available in 10,000 iu bottles. The average hCG dieter would use only 5,000 iu “per cycle”. “Brand name” Pregnyl (Organon USA/Merck), Novarel (Ferring), and Chorionic Gonadotropin (APP) costs $176 per vial. Compounding pharmacies can buy “raw hCG powder” for about $2 per 5,000 iu. Compounding pharmacies sell hCG to physicians for $14 - $34. Physicians then sell hCG to patients for $500 - $1000. HCG, EP Sterile, Lyophyillized Powder. PCCA# 55-3560. Professional Compounding Centers of America (PCCA) Catalog (2011). Phone 800-331-2498. Houston, Tx. http://www.pccarx.com/ Minton BA. Compounding Pharmacy: A Gateway to Increasing Revenues. Presentation by GBTRx Pharmacy to the 16th Annual World Conference on Anti-Aging Medicine. The American Academy for Anti-Aging Medicine (A4M) Conference. July 17-29, 2008. accessed June 1, 2011. PowerPoint - http://roth-communications.com/MP3/DC1555/1555-PC05e.pdf Audio - http://roth-communications.com/MP3/DC1555/1555-PC05e.mp3

Subcutanous vs Intramuscular hCG Obesity decreases rise in hCG levels Subcutaenous (SubQ) route has less bioavailability than intramuscular (IM) injection Chan CC, et al. Bioavailability of hCG after intramuscular or subcutaneous injection in obese and non-obese women. Hum Reprod. 2003 Nov;18(11):2294-7. PMID: 14585876 Elkind-Hirsch KE, et al. Serum human chorionic gonadotropin levels are correlated with body mass index rather than route of administration in women undergoing in vitro fertilization--embryo transfer using human menopausal gonadotropin and intracytoplasmic sperm injection. Fertil Steril. 2001 Apr;75(4):700-4. PMID: 11287022 Stelling JR, et al. Subcutaneous versus intramuscular administration of human chorionic gonadotropin during an in vitro fertilization cycle. Fertil Steril. 2003 Apr;79(4):881-5. PMID: 12749424

Figure 1. Pharmacokinetics of hCG after a single dose of 10 000 IU hCG after intramuscular and subcutaneous injections in obese and non‐obese women. Figure 1. Pharmacokinetics of hCG after a single dose of 10 000 IU hCG after intramuscular and subcutaneous injections in obese and non‐obese women. Chan C C et al. Hum. Reprod. 2003;18:2294-2297 European Society of Human Reproduction and Embryology

Non-MD’s get into the act Google: “HCG Coach” - 5,170,000 hits Google: “HCG Coach Florida” - 2,400,000 hits Chiropractors, Acupuncturists, Dentists, Podiatrists, etc. “HCG Chiropractic Florida”: 1,920,000 results “HCG Acupuncture Florida”: 1,020,000 results Etc.

“Rent a MD license number” Just like in the 1970’s, corporate hCG clinics will pay off a physician to use their license number to prescribe “real” hCG. MD is required to see patients, personally get informed consent, and personally dispense medications to patient (can not be delegated) Cases in Broward/Palm Beach include: Sci-Slim (owned by an ex-football player) THE HCG CURE DIET, LLC (owned by Tiffany’s ex-producer) Bouari Clinic (the owner’s wife, “Dr. Chaney” is a Ph.D. – not licensed to practice anything in Florida) Brian Yusem – bodybuilder trafficking in anabolic steroids And many more …

OTC hCG www.fda.gov/hcgdiet

OTC hCG hCG is a prescription only drug. No “OTC hCG” products are legal. No such thing as “homeopathic hCG” Even “hCG secretagogues”, “hCG precursors” or “hCG stimulators” are illegal if they: Contain the letters “HCG” on the label Imply, by the label or labeling, an intended effect on the human body (such as causing weight loss) Title 21 U.S.C. Chapter 9, (§§ 301 - 399d), the Federal Food, Drug and Cosmetic Act – specifically §352 – Misbranded drugs Sections 499.001-499.081, Florida Statutes, the Florida Food Drug and Cosmetic Act – specifically s. 499.007, F.S. – Misbranded drugs

Starvation and appetite It is easier to be on a 500-kcal diet than a 1,000-kcal diet Starvation causes lack of appetite “SNATT” – Semi-Nauseated All The Time Andik I, et al. The effect of starvation on food intake and selection. Acta Physiol Hung. 1951;2(3-4):363-8. PMID: 14914550 Bloom WL. To fast or exercise. Am J Clin Nutr. 1968 Dec;21(12):1475-9. PMID: 5724825. Keys AJ, et al. The Biology of Human Starvation. Minneapolis: Univ. of Minnesota Press, vol 1. 1950.

Starvation = muscle wasting Quick weight loss is mostly water (and muscle) 800 kcal/day diet Composition of weight lost (percentage) during the ketogenic diet was water 61.2, protein 3.8, fat 35.0. During the mixed diet, composition of loss was water 37.1, protein 3.4 , fat 59.5. The Trick: Lose a pound of fat, you lose a pound on the scale. Lose a pound of muscle, you lose 2-4 pounds on the scale. Yang MU, Van Itallie TB. Composition of weight lost during short-term weight reduction. Metabolic responses of obese subjects to starvation and low-calorie ketogenic and nonketogenic diets. J Clin Invest. 1976 Sep;58(3):722-30

Starvation = bad for your health Heart arrhythmias – prolonged QT, death Skipping breakfast decreases insulin sensitivity Stress response causes hair loss Lowers BMR, makes it harder to lose weight, easier to regain Refeeding syndrome – more danger when start eating again Spencer IO. Death during therapeutic starvation for obesity. Lancet. 1968 Jun 15;1(7555):1288-90. PMID: 4172144 Farshchi HR, et al. Deleterious effects of omitting breakfast on insulin sensitivity and fasting lipid profiles in healthy lean women. Am J Clin Nutr. 2005 Feb;81(2):388-96. PMID: 15699226 Grant AM, et al. Thyroidal hormone metabolism in obesity during semi-starvation. Clin Endocrinol (Oxf). 1978 Sep;9(3):227-31. PMID: 709892 Vincent RP, et al. When the brakes came off: re-feeding oedema after deflation of a gastric band: a case report. Obes Surg. 2009 Oct;19(10):1468-70. Epub 2009 Aug 13. PMID: 19680731

Starvation  regain weight Patients that lose weight on fad diets, gain weight back within a year. At start, average patient: 204 lbs, 65 lbs (47%) overweight. 12 weeks on shakes - 900 kcal, 70 gram protein/d Boredom set in. Patients started to “cheat”, wt loss slowed. Average weight loss was 12.5 lbs, (-12.5% excess wt lost). Within a year, average weight = 202 lbs. Seaton DA, Duncan LJ. Treatment of "refractory obesity" with "formula diet". Br Med J. 1963 Jul 27;2(5351):219-21. PMID: 13987548

- 24.6 day fast No food, only water, tea, coffee, (unsweetened) etc Wt. dec. 26.7 lbs All regained weight (and then some) Exception: one patient lost weight, but lost his job, became depressed, required psych help MacCuish AC, Munro JF, Duncan LJ. Follow-up study of refractory obesity treated by fasting. Br Med J. 1968 Jan 13;1(5584):91-2. PubMed PMID: 5634720

hCG: Legal/ethical issues Prescribing hCG off-label, including for weight control* Dispensing Prescription hCG that is FDA approved (Pregnyl, Novarel, hCG-APP Pharmaceuticals), after writing a valid prescription, handing it to the patient, and allowing a patient to purchase at a pharmacy of his/her own choice. * Exceptions: Louisiana and Mississippi ban hCG prescriptions for weight control. Louisiana Administrative Code. Title 46 – Professional and Occupational Standards. Part XLV. Medical Professions. Chapter 69. Prescription, Dispensation, and Administration of Medications. Subchapter A. Medications Used in the Treatment of Obesity. §§6901-6913. Pages 177 – 179. http://doa.louisiana.gov/osr/lac/46v45/46v45.doc Lowe, Z. Mississippi Bans HCG Prescriptions for Weight Loss. WREG, Channel 3, Memphis, TN. http://www.wreg.com/wreg-mississippi-bans-hcg-prescriptions-for-weight-loss-20120125,0,3534348.story

hCG: Legal/ethical issues Illegal Advertising hCG diet treatments without disclaimer in 10-point all caps (in each and every ad): THESE WEIGHT REDUCTION TREATMENTS INCLUDE THE INJECTION OF HCG, A DRUG WHICH HAS NOT BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION AS SAFE AND EFFECTIVE IN THE TREATMENT OF OBESITY OR WEIGHT CONTROL. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG INCEASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTIVE DIETS. FTC Decisions. Porter & Dietsch, Inc. Docket 9047. 90 F.T.C. 770 (1977), modified, 605 F.2d 294 (7th Cir. 1979), cert. denied, 445 U.S. 950 (1980), amendments to order, 95 F.T.C. 806 (1980). ss. 458.331(1)(d) and 459.015(1)(d), F.S. and Rules 64B8-11.001(2), 64B8-9.012(9), and 64B15-14.001(2), 64B15-14.004(8), F.A.C. – prohibits deceptive advertising

hCG: Legal/ethical issues Illegal Advertising “compounded medications” including: all hCG that is in a form that is not injectable (there are no FDA approved versions of sublingual, oral, topical, or pellet hCG) hCG that would be dispensed in any size other 10,000 iu/bottle (the only approved versions of hCG are in that one size) any hCG (or other drug) from a compounding pharmacy Title 21 U.S.C. Chapter 9, Subchapter V, Part A, §353a(c) – prohibiting the advertising of any compounded medication.  ss. 458.331(1)(d) and 459.015(1)(d), F.S. and Rules 64B8-11.001(2), 64B8-9.012(9), and 64B15-14.001(2), 64B15-14.004(8), F.A.C. – prohibits deceptive advertising

hCG: Legal/ethical issues Illegal Dispensing/distributing “compounded medications” Pharmacies, including “compounding pharmacies” are not “manufacturers” or “wholesalers” “(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding and is not within the practice of the profession of pharmacy. “ Rule 64B16-27.700(2), F.A.C. – regarding compounding pharmacy ss. 458.331(1)(d) and 459.015(1)(d), F.S. and Rules 64B8-11.001(2), 64B8-9.012(9), and 64B15-14.001(2), 64B15-14.004(8), F.A.C. – prohibits deceptive advertising

hCG: Legal/Ethical issues Illegal Not having a M.D. or D.O. personally obtain informed consent and write the prescription for hCG Can’t delegate to ARNP or PA-c acupuncturist, chiropractor, or otherwise unlicensed person, definitely can’t do this. ss. 458.336 and 459.0135, F.S. and Rules 64B8-9.012 and 64B15-14.004, F.A.C. – regarding MD/DO physicians using drugs to treat obesity s. 457.109(1)(q), F.S. – acupuncturists prohibited from practicing outside scope of training/licensure s. 460.413(1)(p), F.S. - Rule 64B2-17.0025(4), F.A.C. – prohibits chiropractors from prescribing or dispensing legend drugs. ss. 456.065 and 458.327(1)(a), F.S. – Practicing medicine without a license

hCG: Legal/Ethical issues Illegal “Restricting a patient’s choice of pharmacy” by: Not writing physical prescriptions and handing them to the patient. Phoning / faxing in prescriptions (for the first hCG cycle) to a pharmacy. Participating in any fee-splitting/kickback/patient brokering relationship with any pharmacy. ss. 458.331(1)(o), 459.015(1)(j), and 465.0276(2)(c), F.S. – restricting choice of pharmacy ss. 456.054, 817.505, 458.331(1)(i), and 459.015(1)(j), F.S. – illegal kickbacks or patient-brokering Rules 64B16-27.1003 and 64B16-27.1042, F.A.C. – regarding telephone/fax prescriptions and patient brokering/kickbacks with a pharmacy

If it’s illegal, why are hCG clinics still in business? “Most of the questionable ‘nutrition’ promotions are nothing more than snake oil remedies, which bilk a gullible public of billions annually, but authorities are reluctant to prosecute under those criminal laws that jail offenders and thus require unanimous decision by a jury.” The promoters get away with false statements and other illegal behaviors that exploit their patients because the law uses gums rather than teeth. Many complaints are shelved because of “lack of manpower.” Herbert V. Legal aspects of specious dietary claims. Bull N Y Acad Med. 1982 Apr;58(3):242-53. PMID: 6956409

hCG: Legal/Ethical issues “The professional community has a responsibility to offer guidance to the public in separating facts from fantasies in the realm of such matters as nutrition and health. … A professional person has a privilege in his field of competence to differ with others in the same field, to speak out strongly, as long as his comments are not made with malice.” Herbert V. Legal aspects of specious dietary claims. Bull N Y Acad Med. 1982 Apr;58(3):242-53. PMID: 6956409

Legal: SLAPP Lawsuits SLAPP = Strategic Lawsuit Against Public Participation Promoters of quackery frequently threaten defamation actions against those who speak the truth about nutrition and “health food” ripoffs. However, truth without malice is a complete defense. For the best description of how to fight a defamation/libel lawsuit, see http://www.citmedialaw.org/sites/citmedialaw.org/files/2009-12-19-Alascio%20Response.pdf Randazza, Marc. “Does Route 60 Hyundai suck?” www.randazza.com/

What to do about hCG? File complaints with the Dept. of Health Unfortunately, the DOH Prosecution Services Unit “tanks cases” all the time, and does not prosecute obvious violations of Florida Statutes and the Florida Administrative Code. Organization Position Statements Position statements against the hCG Diet have been made by the ASBP, the Hormone Foundation, and the Endocrine Society Dr. Woliner is attempting to get the Palm Beach County Medical Society, the Florida Medical Association, and the American Medical Association to take positions on the hCG Diet. Will the Broward County, Florida, and American Dietetic Associations take an “official position” on the use of hCG in weight control? Sample resolution is in your packet.

Know who your elective representatives are. http://www. myfloridahouse Know who your elective representatives are. http://www.myfloridahouse.gov/sections/ representatives/myrepresentative.aspx HOUSE Franklin Sands "Chris“ Smith "Gwyn“ Clarke-Reed Elaine J Schwartz Eleanor Sobel "Joe“ Gibbons "Irv“ Slosberg "Eddy“ Gonzalez Perry E. Thurston, Jr. GOVERNOR Bill Hager "Jim“ Waldman Rick Scott Matt Hudson Barbara Watson Evan Jenne "Marty“ Kiar SENATE George R. Moraitis, Jr. Ellyn Bogdanoff Jeanette M. Nuñez Larcenia J. Bullard "Steve“ Perman Gwen Margolis Ari Porth Nan H. Rich "Hazel“ Rogers Jeremy Ring

Florida House/Senate Bills have to be submitted before the legislative session starts. Call up your legislator and ask, “May I have an appointment, either in person, or via telephone, with you, or your legislative assistant, about ______ issue?” Bring with you a one-page synopsis of your talking points. You can also make appointments with legislators/staff outside your voting district, especially if they are on “key committees”.

Senate Health Regulation Committee Senator Rene Garcia (chairman) 1490 West 68th Street Suite 201 Hialeah, FL 33014 (305) 364-3100 FAX (305) 364-3110 Senator Eleanor Sobel (vice-chair) The "Old" Library, First Floor 2600 Hollywood Blvd. Hollywood, FL 33020 (954) 924-3693 FAX (954) 924-3695 Senator Miguel Diaz de la Portilla 2100 Coral Way Suite 505 Miami, FL 33145 (305) 643-7200 Senator Don Gaetz (president-elect of the Senate) 4300 Legendary Drive Suite 230 Destin, FL 32541 (850) 897-5747 Senator Jim Norman 14031 N. Dale Mabry Blvd. Tampa, FL 33618 (813) 265-6260

Summary: Consequences of hCG Physical damage to patient Fatigue, weakness, hair loss, constipation, etc. Psychological damage to patient Breeding “disordered eating behaviors” Economic damage to patient Exploitation of patient for financial gain Damage to the medical profession’s reputation “health coach” vs. “licensed professional” Economic damage to ethical practitioners due to unfair competition When patients waste financial resources, no money is left to see an ethical professional that could help them.

“An event has occurred of which it is difficult to speak and impossible to remain silent.” -- Edmund Burke Wilmshurst P. The code of silence. Lancet. 1997 Feb 22;349(9051):567-9. PubMed PMID: 9048805.