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Science, Politics, and the Regulation of Dietary Supplements: It's Time to Repeal DSHEA

Published online by Cambridge University Press:  06 January 2021

Peter J. Cohen
Peter J. Cohen*
Affiliation:
Princeton University, Columbia University, Georgetown University Law Center
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Extract

Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerine and limburger cheese … [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of selfstyled panaceas that inventive minds can devise.

[Individuals have] the right to be treated by a health care practitioner with any medical treatment (including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services) that such individual desires or the legal representative of such individual desires.

The makers of our Constitution undertook to secure conditions favorable to the pursuit of happiness. They recognized the significance of man's spiritual nature, of his feelings and of his intellect.

Type
Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 175 - 214
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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References

1 United States v. Rutherford, 442 U.S. 544, 558 (1979).

2 Access to Medical Treatment Act H.R. 2085, 108th Cong. (2003). The bill was first introduced in 1997, but has not been moved out of committee. Among the bill's original sponsors were two major advocates of Complementary and Alternative Medicine, Senators Tom Harkin and Orrin Hatch.

3 Olmstead v. United States, 277 U.S. 439, 478-79 (1928) (Brandeis, J., dissenting).

4 Research Describes Changing Trends in Herbal Supplement Use, LAB BUSINESS WEEK, Mar. 13, 2005, at 37; see also Eisenberg, David M. et al., Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a Follow-up National Study, 280 JAMA 1569, 1575 (1998)CrossRefGoogle Scholar. “Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8% [of those surveyed] in 1990 to 42.1% in 1997. The therapies increasing the most included herbal medicines … [and] megavitamins … [A]lternative therapies were used most frequently for chronic conditions, including back problems, anxiety, depression, and headaches.” Id.

5 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (codified as amended in scattered sections of 21 U.S.C. §§ 301-399 (2000)) [hereinafter DSHEA].

6 DSHEA § 2

7 By “pharmaceuticals,” I mean “drugs” as defined and approved by the Food and Drug Administration (“FDA”) and regulated under the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. §§ 301-397 (2000). I will use the terms “drugs” and “pharmaceuticals” interchangeably. By “dietary supplements,” I mean those compounds defined, regulated, and marketed under DSHEA.

8 DSHEA § 3(a)(ff).

9 DSHEA § 3.

10 DSHEA § 3(a)(ff)(1)(C).

11 A claim of intent to treat disease would classify the compound as an FDA-regulated drug rather than a DSHEA-regulated supplement. See 21 U.S.C. § 321(g)(1)(B).

12 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-97. (2000).

13 442 U.S. at 544; H.R. 2085.

14 UPTON SINCLAIR, THE JUNGLE (Gene DeGruson ed., Peachtree Publishers 1988) (first published serially in 1905 and then as a complete book in 1906).

15 Id. at 121-22.

16 See PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS ch. 1 (The Foundation Press, 2d ed. 1991).

17 FDA, The Long Struggle for the 1906 Law, FDA CONSUMER, June 1981, at http://www.cfsan.fda.gov/∼lrd/history2.html.

18 HUTT & MERRILL, supra note 16, at 1-22.

19 Hayes, Arthur H. Jr.,, Food and Drug Regulations After 75 Years, 246 JAMA 1223, 1224 (1981)CrossRefGoogle Scholar.

20 21 U.S.C. § 355(b)(1).

21 Kefauver-Harris Amendment of 1962, Pub. L. No. 87-781, 76 Stat. 780 (codified in scattered sections of 21 U.S.C. §§ 301-399 (2000)); Beckford, C. Frederick III, The FDA's War on Drugs, 82 Geo. L.J. 529, 529-30 (1993)Google Scholar (explaining the effect of the Kefauver-Harris Amendment).

22 Beckford, supra note 21, at 530 (describing market failures that demonstrate the need for consumer protection in the pharmaceutical industry).

23 Stephen Barrett, How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA (2000), available at http://www.quackwatch.org/02ConsumerProtection/dshea.html (last accessed on May 10, 2005).

24 Id.

25 STEPHEN BARRETT & V. HERBERT, THE VITAMIN PUSHERS: HOW THE HEALTH FOOD INDUSTRY IS SELLING AMERICA A BILL OF GOODS (1994).

26 DSHEA § 3

27 Schneiderman, Lawrence J., The (Alternative) Medicalization of Life, 31 J. Law, Med. & Ethics 191, 193 (2003)CrossRefGoogle ScholarPubMed (quoting Dr. David Kessler from Canedy, Dana, Read Medicine or Medicine Show? Growth of Herbal Remedy Sales Raises Issues About Value, N.Y. TIMES, July 23, 1998, at D1)Google Scholar.

28 Id.

29 Congressional “findings” within any statute are usually unimpeachable. Nonetheless, it is clear that the reach of DSHEA extends far beyond the goal of providing excellent nutrition to our population.

Congress finds that –

  • (1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;

  • (2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;

  • (3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and

  • (B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;

  • (4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;

  • (5) preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;

  • (6)(A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and

  • (B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country. DSHEA § 2 (quoted in part).

30 Id.

31 See Kauflin, Stephanie, Dietary Supplements: Is Availability Worth the Risks? Proposed Alternatives to the Present DSHEA Scheme, 33 Seton Hall L. Rev. 411, 429 (2003)Google ScholarPubMed (describing regulatory schemes enacted by individual states in reaction to gaps in consumer protection created by DSHEA).

32 21 U.S.C. §§ 301(g)(1)(B) and (C) (emphasis added).

33 DSHEA § 3(a)(ff) (quoted in part).

34 Harmon, Sean, Melatonin Mania: Can the FDA Regulate Hormonal Dietary Supplements to Protect Consumer Interests in Light of the Dietary Supplement Health and Education Act of 1994?, 22 U. Dayton L. Rev. 77, 94 (1996)Google Scholar (stating that consumers purchase supplements to achieve a desired benefit).

35 21 U.S.C. § 355(a); compare DSHEA § 8.

36 21 U.S.C. § 355(a).

37 21 U.S.C. § 355(d)(7).

38 21 U.S.C. § 321(n).

39 21 U.S.C. § 352.

40 Id.

41 21 U.S.C. § 321(n).

42 21 U.S.C. § 342(f).

43 Id. (stating that the government bears the burden of proof to show than a dietary supplement is adulterated).

44 See 21 U.S.C. § 355b.

45 DSHEA § 6.

46 See Kauflin, supra note 31, at 423.

47 21 U.S.C. § 360e.

48 See 21 U.S.C. § 321(p).

49 DSHEA § 4.

50 Id.

51 Kessler, David, Cancer and Herbs, 342 New Eng. J. Med. 1742, 1742-43 (2000)CrossRefGoogle ScholarPubMed.

52 DeAngelis, Catherine D. & Fontanarosa, Phil B., Drugs Alias Dietary Supplements, 290 JAMA 1519, 1519-20 (2003)CrossRefGoogle ScholarPubMed.

53 WHITE HOUSE COMMISSION ON COMPLEMENTARY AND ALTERNATIVE MEDICINE POLICY, FINAL REPORT ch.2 (2002), available at http://www.whccamp.hhs.gov/finalreport.html); see also Boozang, Kathleen M., National Policy on CAM: The White House Commission Report, 31 J.L Med. & Ethics 251 (2003)CrossRefGoogle ScholarPubMed.

54 INSTITUTE OF MEDICINE, DIETARY SUPPLEMENTS: A FRAMEWORK FOR EVALUATING SAFETY (2004); see also Marc Kaufman, Oversight of Supplement Makers Advised: Panel Recommends That FDA be Given More Resources to Find Problem Products, WASH. POST, Apr 2, 2004, at A9.

55 Eisenberg et al., supra note 4, at 1575.

56 Id.

57 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 63 Fed. Reg. 23624-01 (proposed Apr. 29, 1998) [hereinafter Proposed Regulations on Statements].

58 21 C.F.R. pt. 101.

59 FDA, FDA Finalizes Rules for Claims on Dietary Supplements, FDA Talk Paper, Jan. 5, 2000, available at http://www.cfsan.fda.gov/∼lrd/tpdsclm.html.

60 21 C.F.R. § 101.93(g)(1).

61 OFFICE OF DIETARY SUPPLEMENTS, Dietary Supplements: Background Information, at http://ods.od.nih.gov/factsheets/DietarySupplements.asp.

62 21 U.S.C. §§ 343(r)(6)(A-D).

63 See Pinco, Robert G. & Halpern, Todd H., Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After Enactment of the Dietary Supplement Health and Education Act of 1994, 54 Food & Drug L.J. 567, 577 (1999)Google ScholarPubMed.

64 21 C.F.R. § 101.93(g)(2)(i)(2005).

65 See Proposed Regulations on Statements, supra note 57, at 1012; see also Gilhooley, Margaret, Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice, 49 Fla. L. Rev. 665, 685-86 (1997)Google Scholar (providing several examples of claims made for supplements that “would not have qualified for exemption from the drug provisions under the earlier judicial test” including the claim that “ginkoba improves memory and concentration’ and enhance[es] your mental focus’”).

66 21 C.F.R. § 101.93(g)(2)(ii).

67 See Gilhooley, supra note 65, at 685-86; Rebecca Porter, Government, Health Advocates, Lawyers Challenge Safety of Weight-Loss Supplement, TRIAL, Jan. 2003, at 12.

68 21 C.F.R. §§ 101.93(g)(2)(iv)(D), (g)(2)(viii)(2005).

69 See LEWIS CARROLL, ALICE's ADVENTURES IN WONDERLAND AND THROUGH THE LOOKING GLASS 185 (Oxford University Press 1982) (1971) (“When I use a word,’ Humpty Dumpty said in a rather scornful tone, it means just what I choose it to mean—neither more nor less.’ The question is,’ said Alice, whether you can make words mean so many different things.’ The question is,’ said Humpty Dumpty,’ which is to be master—that's all.’”).

70 21 U.S.C. §§ 343(r)(1)(B).

71 See 21 U.S.C. §§ 333, 334.

72 21 CFR § 101.14(c) (2005).

73 U.S. CONST. amend I (“Congress shall make no law…abridging the freedom of speech, or of the press…”).

74 See Proposed Regulations on Statements, supra note 57, at 1001; 21 C.F.R. § 101.93(b).

75 See, e.g., Pearson v. Shalala, 164 F.3d 650, 655-60 (D.C. Cir. 1999).

76 Id.

77 Id. at 651-52.

78 Id. at 665.

79 Id. at 654.

80 Id. at 655-56.

81 Id. at 661.

82 Cent. Hudson Gas v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 563 (1980).

83 Id. at 566.

84 Shalala, 164 F.3d at 655-61.

85 Id. at 656.

86 Id. at 657 (emphasis added).

87 See, e.g., Morris, Charles A. & Avorn, Jerry, Internet Marketing of Herbal Products, 290 JAMA 1505, 1506 (2003)CrossRefGoogle ScholarPubMed (“We searched the Internet using the 5 most common used search engines. For each, we entered the names of the 8 most widely used herbal supplements (ginkgo biloba, St. John's wort, echinacea, ginseng, garlic, saw palmetto, kava kava, and valerian root). We analyzed the health content of all Web sites listed on the first page of the search results…A total of 273 (81%) of the 338 retail Web sites [involved in the sale of supplements] made 1 or more health claims; of these, 149 (55%) claimed to treat, prevent, diagnose, or cure specific diseases. More than half…of sites with a health claim omitted the standard federal disclaimer….Customers may be misled by vendors’ claims that herbal products can treat, prevent, diagnose, or cure specific diseases, despite regulations prohibiting such statements.”).

88 See, e.g., FDA, DIETARY SUPPLEMENT ENFORCEMENT REPORT (2002), available at http://www.fda.gov/oc/nutritioninitiative/report.html (providing synopses of several relevant cases including U.S. v. Diane Eckert-Kunick, where a manufacturer and distributor of dietary supplements including colloidal gold, colloidal silver, and colloidal titanium claimed that the supplements could cure cancer, rheumatoid arthritis and heart disease. In April 2002, Eckert-Kunick was convicted of introducing unapproved new drugs into interstate commerce and sentenced to four months incarceration in a community correctional center. No. MG-F-02-2093 (E.D. Cal.). Another illustrative case was U.S. v. Theodore Sosangelis and Thomas Knox, where the defendants were convicted of conspiracy to distribute counterfeit dietary supplements by producing an inexpensive version of legal supplements manufactured by Muscletech. After placing fake Muscletech labels on their products, defendants sold them to customers who believed that they were purchasing legitimate Muscletech dietary supplements. After a guilty plea to one felony count of trafficking counterfeit goods in interstate commerce, defendant was sentenced to 3 years probation and was order to pay restitution of almost $77,000. Nos. CR301-238, CR301-289 (D. Conn.)).

89 Id.

90 21 U.S.C. § 342(f).

91 Ephedrine, the active ingredient in dietary supplements containing ephedra alkaloids, is a pharmaceutical regulated by the FD&C Act and used for the statutory purposes established for a “drug.” The totally different regulatory schemes imposed on ephedrine, the drug, and ephedra, the supplement, clearly illustrates the fiction of DSHEA's classification. Compare the status of medical marijuana. Ten states currently permit the use of marijuana for medical purposes. See, e.g., CAL. HEALTH & SAFETY CODE § 11362.5 (2005); OR. REV. STAT. §§ 475.300-475.346. If marijuana were decriminalized, would it achieve the status of a legitimate and lucrative “herbal remedy” under provisions of DSHEA? Conversely, since its advocates insist that it can treat disease and those who use it so intend, would the FDA require approval as a drug before it could be legally advertised? If so, would any manufacturer then be willing to undertake the expense of drug approval?

92 Leak, Jessie A., The Dietary Supplement Scene: An Update, 68 Am. Soc’Y Of Anesthesiologists Newsletter 29 (2004)Google Scholar.

93 Id.

94 Id.

95 Ling, Amy M., FDA to Ban Sales of Dietary Supplements Containing Ephedra, 32 J.L. Med. & Ethics 184, 184 (2004)Google ScholarPubMed.

96 Id.

97 Shekelle, Paul G. et al., Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance: A Meta-Analysis, 289 JAMA 1537, 1544 (2003)Google ScholarPubMed.

98 See Harris, Gardiner, Judge's Decision Lifts Ban on Sale of Ephedra in Utah, N.Y. TIMES, Apr. 15, 2005Google Scholar, at A12 (“A federal judge in Utah…struck down an FDA ban on the herbal supplement ephedra, … [holding that] the drug agency had failed to prove that ephedra at low doses was dangerous, and that it lacked the authority to ban the substance without such proof.”).

99 FDA, No. P04-101, FDA ANNOUNCES MAJOR INITIATIVES FOR DIETARY SUPPLEMENTS, at http://ww.fda.gov/bbs/topics/news/2004/NEW01130.html (Nov. 4, 2004).

100 Id.

101 Id.

102 Id.

103 See, e.g., GOV't ACCOUNTABILITY OFFICE, No. 01-1129, HEALTH PRODUCTS FOR SENIORS: ANTI-AGING PRODUCTS POSE POTENTIAL FOR PHYSICAL AND ECONOMIC HARM, at http://www.gao.gov/new.items/d011129.pdf (Sept. 2001).

104 George Mandel, H. & Weiss, William P., Fat-Soluble Vitamins, in The Pharmacological Basis Of Therapeutics 1684 (Lewis S. Goodman & Alfred Gilman eds., 3d ed. 1965)Google Scholar.

105 Id.

106 Stein, Rob, High Doses of Vitamin E Found to Raise Risk of Dying, WASH. POST, Nov. 11, 2004Google Scholar, at A1.

107 Miller, Edgar R. et al., Meta-Analysis: High-Dosage vitamin E Supplementation May Increase All-Cause Mortality, 142 Ann. Int. Med. 1 (2005)CrossRefGoogle ScholarPubMed.

108 See DSHEA § 3.

109 Nick Salazar, The Case of Toxic Tryptophan, in REPORT ON GENETICALLY MODIFIED FOOD CROPS, at http://www.nd.edu/∼chem191/d3.html (Mar. 25, 2005); see also Ingeborg Boyens, The Skeleton in the GMO Closet: Did Genetic Engineering Cause the Tryptophan-EMS Disaster of 1989?, THE AQUARIAN (Spring 2000), at http://www.aquarianonline.com/Eco/UnnaturalHarvest.html; Belongia, E. A. et al., The Eosinophilia-Myalgia Syndrome and Tryptophan, 12 Ann. Rev. Nutrition 235 (1992)CrossRefGoogle ScholarPubMed.

110 See infra pp. 209-11.

111 See supra note 91.

112 Moe, Gordon K. & Farah, Alfred E., Digitalis and Allied Cardiac Glycosides, in The Pharmacological Basis Of Therapeutics 685 (Louis S. Goodman & Alfred Gilman, eds., 3d. ed. 1965)Google Scholar.

113 ATTORNEY's DICTIONARY OF MEDICINE 86 (2003).

114 See Rall, Theodore W. & Schleifer, Leonard S., Oxytocin, Prostaglandins, Ergot Alkaloids, and Other Agents, in The Pharmacological Basis Of Therapeutics 935, 939-40 (Louis S. Goodman & Alfred Gilman eds., 5th ed. 1975)Google Scholar.

115 Id. at 939-40.

116 See Paul A. Kimpel, The History of Dietary Supplements, at http://iml.jou.ufl.edu/projects/Spring2000/Kimpel/history.html (last visited May 17, 2005).

117 Flower, Roderick J. et al., Analgesic-Antipyretics and Anti-Inflammatory Agents: Drugs Employed in the Treatment of Gout, in Goodman And Gilman'S The Pharmacological Basis Of Therapeutics 682, 695 (Alfred Goodman Gilman, Louis S. Goodman & Alfred Gilman eds., 6th ed. 1980)Google Scholar.

118 Rollo, Ian M., Drugs Used in the Chemotherapy of Malaria, in Goodman And Gilman'S The Pharmacological Basis Of Therapeutics 1054, 1056 (Alfred Goodman Gilman, Louis S. Goodman & Alfred Gilman eds., 6th ed. 1980)Google Scholar.

119 See Nortier, Jolle L. et al., Urothelial Carcinoma Associated with the Use of a Chinese Herb (Aristolochia Fangchi), 342 New Eng. J. Med. 1686 (2000)CrossRefGoogle Scholar.

120 Id.

121 Alexander Otto, M., Weed Killer, WASH. POST, Apr. 24, 2001Google Scholar, at T06.

122 See De Smet, Peter A.G.M., Herbal Remedies, 347 New Eng. J. Med. 2046, 2047 (2002)CrossRefGoogle ScholarPubMed.

123 Id.

124 Id.

125 Fugh-Berman, Adriane & Myers, Adam, Citrus aurantium, an Ingredient of Dietary Supplements Marketed for Weight Loss: Current Status of Clinical and Basic Research, 229 Exp. Biol. Med. 698 (2004)CrossRefGoogle ScholarPubMed.

126 Ang-Lee, Michael K. et al., Herbal Medicines and Perioperative Care, 286 JAMA 208 (2001)CrossRefGoogle ScholarPubMed; see also AM. SOC’Y OF ANESTHESIOLOGISTS, WHAT YOU SHOULD KNOW ABOUT YOUR PATIENTS’ USE OF HERBAL MEDICINES AND OTHER DIETARY SUPPLEMENTS (2003).

127 Yuan, Chun-Su et al., Brief Communication, American Ginseng Reduces Warfarin's Effect in Healthy Patients: A Randomized, Controlled Trial, 141 Ann. Int. Med. 23 (2004)CrossRefGoogle ScholarPubMed.

128 See Finkel, Richard S. & Zarlengo, Karen M., Blue Cohosh and Perinatal Stroke, 351 New Eng. J. Med. 302 (2004)CrossRefGoogle ScholarPubMed; see also Jones, T. K. & Lawson, B. M., Profound Neonatal Congestive Heart failure Caused by Maternal Consumption of Blue Cohosh Herbal Medication, 132 J. Pediatr. 550 (1998)CrossRefGoogle ScholarPubMed.

129 Id.

130 Mitka, Mike, FDA Issues Warning on “All-Natural” Herbal Product Found to Contain Viagra, 289 JAMA 2786 (2003)Google ScholarPubMed. There have been reports of death resulting from contamination of PC-SPES (sold for treating “prostate health”) with warfarin (an anti-clotting pharmaceutical) and estrogens. One user, diagnosed with prostate cancer, told his daughter, “I thought it was great there was a natural product available.” Gillis, Justin, Herbal Remedies Turn Deadly for Patients, WASH. POST, Sept. 5, 2004Google Scholar, at A1.

131 Saper, Robert R. et al., Heavy Metal Content of Ayurvedic Herbal Medicine Products, 292 JAMA 2868 (2004)CrossRefGoogle ScholarPubMed.

132 Hampton, Tracy, More Scrutiny for Dietary Supplements?, 293 JAMA 27, 28 (2005)Google ScholarPubMed.

133 See, e.g., SHERWIN B. NEWLAND, DOCTORS: THE BIOGRAPHY OF MEDICINE (1988) (“[Galen] wrote with authority. It was frozen Galenic authority … that rang down through the centuries. He drew attention to his conclusions—not to the means that had created these conclusions … When Galileo and others began building a new science based on experiments, physicians … began to correct [Galen’s] errors. And Galen began his long fall from grace.”); see also UNIVERSITY OF VIRGINIA HEALTH SYSTEM, GALEN, in ANTIQUA MEDICIN: FROM HOMER TO VESALIUS, available at http://www.med.virginia.edu/hs-library/historical/antiqua/galen.htm (“Galen, for all his mistakes, remained the unchallenged authority for over a thousand years. After he died in 203 CE, serious anatomical and physiological research ground to a halt, because everything there was to be said on the subject had been said by Galen, who, it is reported, kept at least 20 scribes on staff to write down his every dictum.”).

134 See supra note 133 and accompanying text.

135 Note that the establishment paradigm itself was often based far more on tradition and authority than rigorous science.

136 See Ford, A.C. et al., Eradication Therapy in Helicobacter Pylori Positive Peptic Ulcer Disease: Systematic Review and Economic Analysis, 99 Am. J. Gastroenterology 1833 (2004)CrossRefGoogle ScholarPubMed (“H. pylori eradication therapy reduces the recurrence of peptic ulcer disease and is cost-effective.”).

137 Pai, Jennifer K. et al., Inflammatory Markers and the Risk of Coronary Heart Disease in Men and Women, 351 New Eng. J. Med. 2599 (2004)CrossRefGoogle ScholarPubMed (“Elevated levels of inflammatory markers, particularly C-reactive protein, indicate an increased risk of coronary heart disease …. [T]he level of C-reactive protein remained a significant contribution to the prediction of coronary heart disease”); see also Ridker, Paul R. et al., C-Reactive Protein Levels and Outcomes After Statin Therapy, 352 New Eng. J. Med. 20 (2005)CrossRefGoogle ScholarPubMed (“Patients with low CRP levels [an index of inflammation] after statin therapy have better clinical outcomes than those with higher CRP levels, regardless of their levels of LDL (bad’) cholesterol.”).

138 Soto, Claudio, Diagnosing Prion Diseases: Needs, Challenges and Hopes, 2 Nat. Rev. Microbiology 809 (2004)CrossRefGoogle ScholarPubMed (“Prion diseases are among the most intriguing infectious diseases. Prions seem to lack nucleic acid and propagate by transmission of protein misfolding.”).

139 PETER J. COHEN, DRUGS, ADDICTION, AND THE LAW: POLICY, POLITICS, AND PUBLIC HEALTH 6 (2004).

140 See AM. PSYCHIATRIC ASS’N, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS [DSM-IV] (4th ed. 1994); see also Quinsey, V.L., The Etiology of Anomalous Sexual Preferences in Men, 989 Ann. N.Y. Acad. Sci. 105 (2003)CrossRefGoogle ScholarPubMed (“People discover rather than choose their sexual interests… . [Sexual preferences] appear to be caused by the neural organizational effects of intrauterine hormonal events.”).

141 While Semmelweis's methodology was a deviation from establishment medical practice, it was verified by a controlled scientific experiment.

142 G.B. Risse, Ignaz Philipp Semmelweis, in DICTIONARY OF SCIENTIFIC BIOGRAPHY (Charles C. Gilespie ed., 1970-1980, available at http://www.uh.edu/admin/engines/epi622.htm (last visited May 10, 2005).

143 During the period preceding passage of DSHEA, an intense lobbying campaign portrayed FDA inspectors as “jackbooted bureaucrats,” raiding the drug cabinets of innocent people whose sole “crime” was possession of vitamins. See, e.g., Shannon Brownlee, Law of Nature, HEALTH, Oct. 2004, available at http://www.newamerica.net/index.cfm?pg=article&DocID=1991.

144 See NATIONAL CANCER INSTITUTE, Questions and Answers about the Gonzalez Protocol Trial, at http://www.nci.nih.gov/clinicaltrials/developments/qa-gonzalez-trial1299#Anchor-Wh-7299 (Dec. 8, 2004); see also NATIONAL CANCER INSTITUTE, Antineoplastons, at http://cis.nci.nih.gov/fact/7_43.htm (use of antineoplastons to “cure” inoperable brain tumors); Knudtson, Merril L. et al., Chelation Therapy for Ischemic Heart Disease: A Randomized Controlled Trial, 287 JAMA 481 (2002)CrossRefGoogle ScholarPubMed (study demonstrated a popular alternative therapy for coronary artery disease to be without efficacy).

145 See JOHN STUART MILL, ON LIBERTY (John Gray & G.W. Smith eds., Routledge 1991) (1859).

146 Id. at 30.

147 Id. at 94-95.

148 Cf. John Donne, XVII: Nunc Lento Sonitu Dicunt, Morieris [Now, this bell tolling softly for another, says to me: Thou must die.], in DEVOTIONS UPON EMERGENT OCCASIONS (Anthony Raspa ed., McGill-Queen's Univ. Press 1975 (1623)) (“No man is an island, entire of itself; every man is a piece of the continent, a part of the main. If a clod be washed away by the sea, Europe is the less, as well as if a promontory were, as well as if a manor of thy friend's or of thine own were: any man's death diminishes me, because I am involved in mankind, and therefore never send to know for whom the bell tolls; it tolls for thee.”).

149 See generally Gostin, Lawrence O., Public Health Law in a New Century Part II: Public Health Powers and Limits, 283 JAMA 2979 (2000)CrossRefGoogle Scholar.

150 See generally id.

151 Id. at 2979.

152 Id. at 3118.

153 United States v. Rutherford, 442 U.S. 544 (1979).

154 Id. at 544.

155 21 U.S.C. § 355(a).

156 21 U.S.C. § 355(d)(7).

157 The claim that Laetrile is entirely devoid of toxicity is not necessarily true. Depending on how it is compounded, it may contain cyanide. In addition, an NIH-sponsored study eventually demonstrated that Laetrile was unable to effect the cures it claimed. See NATIONAL CANCER INSTITUTE, Laetrile/Amygdalin: Questions and Answers, at http://cis.nci.nih.gov/fact/9_3.htm.

158 Rutherford, 442 U.S. at 550-53.

159 TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 178 (5th ed. 2001) (stating that paternalism is “the principle and practice of paternal administration; government as by a father; the claim or attempt to supply the needs or to regulate the life of a nation or community in the same way a father does those of his children”).

160 Rutherford, 442 U.S. at 558.

161 Since the FDA Act has jurisdiction only over interstate commerce, an individual state may allow treatment with unapproved drugs so long as all aspects of such use remain within its borders.

162 Rutherford, 442 U.S. at 554.

163 NATIONAL CANCER INSTITUTE, Laetrile/Amygdalin: Human/Clinical Studies, at http://www.cancer.gov/cancertopics/pdq/cam/laetrile/HealthProfessional/page5. Rutherford was adjudicated 15 years prior to enactment of DSHEA. Had DSHEA been passed prior to 1979, Laetrile, a “botanical” derived from apricot pits, would have been classified as a dietary supplement used “for immune health.” Would this claim, legal under DSHEA, have been interpreted by individuals diagnosed with cancer as indicating its ability to cure cancer thus resulting in its use by numerous gullible patients?

164 See Gostin, supra note 149.

165 See id.

166 Feikin, Daniel R. et al., Individual and Community Risks of Measles and Pertussis Associated with Personal Exemptions to Immunization, 284 JAMA 3145 (2000)CrossRefGoogle Scholar (“The risk of measles and pertussis (whooping cough) is elevated in children whose parents do not allow them to be vaccinated. Moreover, because immunization is not 100% effective, children who had been immunized were placed at potential risk by association with non-immunized children. Schools with pertussis outbreaks had almost three-times more unvaccinated children than those without outbreaks, and at least 11% of immunized children had become infected through contact with an unvaccinated child. Note that unimmunized children are a hazard not only to themselves but to children who have been immunized.”).

167 Cummings, Peter & Rivara, Frederick P., Car Occupant Death According to the Restraint Use of Other Occupants: A Matched Cohort Study, 291 JAMA 343 (2004)CrossRefGoogle ScholarPubMed (“A car occupant can be killed if struck by another occupant who was catapulted forward, backward, or sideways in a crash. The risk of death for an occupant wearing a seat belt was significantly greater when others did not use the belt. Persons who wish to reduce their risk of death in a crash should wear a restraint and should ask others in the same car to use their restraints.”).

168 See, e.g., Cohen, supra note 139, at 7.

169 Buck v. Bell, 274 U.S. 200 (1927).

170 Id. at 205.

171 Id. at 207.

172 STEPHEN JAY GOULD, THE FLAMINGO's SMILE—REFLECTIONS IN NATURAL HISTORY 307- 13 (1985) (quoting a letter the author received from Paul Lombardo of the School of Law at the University who had visited Carrie Buck in the institution to which she had been committed).

173 Id. (“Carrie Buck was one of several illegitimate children borne by her mother, Emma … She was raped by a relative of her foster parents, then blamed for the resulting pregnancy. Almost surely, she was (as they used to say) committed to hide her shame (and her rapist's identity), not because enlightened science had just discovered her true mental status. In short, she was sent away to have her baby. Her case was never about mental deficiency; Carrie Buck was persecuted for supposed sexual immorality and social deviance.”).

174 Dworkin, Gerald, Paternalism, in Paternalism 33 (Rolf Sartorius ed., 1983)Google Scholar.

175 Access to Medical Treatment Act, H.R. 2085, 108th Cong. (2003).

176 Id.

177 Clinical Trial Subjects: Adequate FDA Protections?: Hearing before the House Committee on Government Reform and Oversight, 105th Cong. (1998) (testimony of Michael A. Friedman, Deputy Lead Commissioner, FDA).

178 H.R. 2085.

179 Is it possible to conclude that the treatment will not “cause danger to the patient” without adequate testing? Can random and uncontrolled anecdotal reports provide this information?

180 Is it ever justified to allow individuals to assume the risk of untried, and potentially harmful, therapy? Why not allow the same “freedom” for choice of attorney, e.g., why not extrapolate the right of individuals to conduct their own pro se defense to allowing them to be defended by anybody they select?

181 Again, if controlled studies are not required, how can this information ever be obtained?

182 Is it ever possible to obtain completely knowledge-based consent? Do physicians or CAM practitioners abrogate their fiduciary duties by asking their patients to take a risk that is unknowable because of inadequate scientific investigation? Does this provision impact on the phenomenon of offlabel use of pharmaceuticals?

183 Dworkin, supra note 174, at 28.

184 Id. at 33.

185 Id. at 33; see also Cummings & Rivara, supra note 167.

186 Dworkin, supra note 174, at 34 (emphasis added).

187 See Elizabeth Zuk, Cary, Herbal Remedies Are Not Dietary Supplements: A Proposal for Regulatory Reform, 11 Hastings Women'S L.J. 29, 53–54 (2000)Google Scholar (stating that public health concerns over unapproved herbal remedies marketed as herbal alternatives to prescription drugs cannot be alleviated by a disclaimer).

188 Dworkin, supra note 174.

189 H.R. 2085.

190 See Guidance for Institutional Review Boards and Clinical Investigators 1998 Update: “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices, at http://www.fda.gov/oc/ohrt/irbs/offlabel.html (Apr. 17, 2001).

191 See id.

192 United States v. Evers, 453 F. Supp. 1141, 1143, 1149 (M.D. Ala. 1978) (“[L]icensed physicians have a right and a duty to use drugs in prescribing for their patients’ usage in accordance with their best judgment as physicians … Congress did not intend the Food and Drug Administration to interfere with medical practice as between the physician and the patient … It is well-recognized that a package insert may not contain the most up to date information about a drug and the physician must be free to use the drug for an indication not in the package insert when such usage is part of the practice of medicine and for the benefit of the patient … [T]he physician can ascertain from medical literature and from medical meetings new and interesting proposed uses for drugs marketed under package inserts not including the proposed usages.”).

193 See id. at 1149.

194 Id. at 1150.

195 See Stephanie Stapleton, Science Must be Key in Off-label Drug Information, AM. MED. NEWS, Aug. 18, 1997, available at http://www.ama-assn.org/amednews/1997/pick_97/pick0818.htm.; Cecil B. Wilson, AMA testifies at drug safety hearing, at http://www.amaassn.org/ama/pub/category/14777.html (Mar. 3, 2005).

196 Hearings before a subcommittee of the House Committee on Government Operations, 92nd Congress, 1st Session (1971); see HUTT & MERRILL, supra note 16, at 618-19.

197 Cohen, Peter J., “Off-Label” Use of Prescription Drugs: Legal, Clinical and Policy Consideration, 14 Eur. J. Anaesthesiology 231, 234 (1997)CrossRefGoogle Scholar.

198 Id. at 232-33 (“off-label use” not allowed without FDA evaluation of safety and efficacy for the “labeled” use).

199 Approved drugs may not be advertised for off-label use.

200 Emma Lee Murphy, Washington Report: What You Need to Know About “Off-Label” Uses of Prescription Drugs, Medical Devices, and Biologics, 8 EXPLORE ISSUE (1998), at http://www.explorepub.com/articles/washreport3.html.

201 An Open-source Shot in the Arm?, Economist.com (Jun. 10, 2004), at http://economist.com/PrinterFriendly.cfm?Story_ID=2724420.

202 See, e.g., COMMITTEE ON DRUGS, Unapproved Uses of Approved Drugs: The Physician, The Package Insert, and the Food and Drug Administration: Subject Review, 98 Pediatrics 143 (1996)Google Scholar (“Three fourths of prescription drugs marketed in the United States are not approved for use in children.”); see also Cot, Charles J. et al., Is the “Therapeutic Orphan” About to be Adopted?, 98 Pediatrics 118 (1996)Google Scholar (“Fentanyl is used in children despite the knowledge that its pharmacokinetics are significantly altered by age-specific activity of enzymatic metabolism and neonatal hepatic blood flow.”).

203 Best Pharmaceuticals for Children Act, Pub. L. No. 107-109, 115 Stat. 140 (2005).

204 MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT (2004).

205 Two competing, and perhaps incompatible, philosophies are evident throughout this manuscript: (1) I want to take care of myself so get the government off my back (2) I want protection, so where was the FDA when Vioxx™ and Celebrex™ were being evaluated and after they were approved and marketed?

206 TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 77-112 (5th ed. 2001).

207 Knowledge is an extraordinarily difficult area to analyze. The requirement that advertising be neither false nor misleading (see Central Hudson Gas, 447 U.S. at 557) assumes a minimal level of knowledge to be possessed by the public at large. The extent to which this requirement is satisfied, or can be evaluated by policymakers, is far beyond the scope of this Article.

208 See State ex rel. O’Sullivan v. Heart Ministries, 607 P.2d 1102 (Kan. 1980) (holding that state licensing requirements for a maternity hospital, boarding home, or placement agency are based on the state's parens patriae power to protect children within its borders).

209 While such enforcement of standards mandated by the FD&C Act prevents individuals from accessing impure, unsafe, and ineffective pharmaceuticals, it does not preclude them and their physicians from exercising their free choice of drugs once they have been approved.

210 Eisenberg et al., supra note 5, at 1572 (Table 2: Use of megavitamins more than doubled between 1990 and 1997).

211 21 U.S.C. § 321(g) (emphases added).

212 See supra note 69 and accompanying text.

213 Harris, Gardiner, Regulation Defined: The FDA Shifts Focus; At FDA, Strong Drug Ties and Less Monitoring, N.Y. TIMES, Dec. 6, 2004Google Scholar, at A1 (“Under the 1992 agreement [to initiate “user fees” paid by sponsors to the FDA to increase the speed of review], the industry promised to give the agency millions—in the 2003 fiscal year, $200 million—but only if the agency spent a specified level of money on new drug approvals. As Congressional support sank since then, the agency has cut everything else but new drug reviews. In the past 11 years, spending on the reviews has increased to more than four-fifths of the budget of the agency's drug center from about half.”).

214 Kaufman, Marc & Masters, Brooke A., After Criticism, FDA Will Strengthen Drug Safety Checks, WASH. POST, Nov. 6, 2004Google Scholar, at A12 (“The FDA is attempting to change the system, a system deficient not only because of funding but “culture.” Responding to continuing criticism that it mishandled internal warnings that the painkiller Vioxx had deadly side effects and that antidepressants were being misprescribed for children, the Food and Drug Administration announced yesterday that it will strengthen its system for reviewing the safety of drugs already on the market. Without saying that the agency had done anything wrong, acting Commissioner Lester M. Crawford outlined a series of steps the agency will take to become more aggressive about responding to reports of potentially harmful side effects. As part of its effort to strengthen safety monitoring, the FDA will establish a formal program for agency scientists who disagree with decisions about specific drugs. The scientists will be able to present their views to a panel of FDA and outside experts, who will be required to come back with a recommendation within 30 days.”); see also Kaufman, Mark, Many FDA Scientists Had Drug Concerns, 2002 Survey Shows, WASH. POST, Dec. 16, 2004Google Scholar, at A1 (“Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality … Similarly, 21 percent of survey respondents said the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely.”).

215 Kennedy, Donald, Clinical Trials and Public Trust, 306 Science 1649 (2004)CrossRefGoogle ScholarPubMed (“Through no fault of the FDA, the United States has lacked a system that can detect things that go wrong with an already-marketed drug. Physicians are asked to make voluntary reports and manufacturers are required to tell the FDA when they spot a problem, but there's little incentive for either. Moreover, there is no centralized way of knowing how much of a given drug is being used, so there is no denominator and no adverse reaction rate can be calculated.”); see also Harris, supra note 213 (“Among the priorities that took the worst hit was ensuring the safety of the drugs that patients are already taking. Drug companies test their products in people before they are approved, but sometimes potentially serious problems arise only when they are being used by millions of people. The FDA has never been able to require drug makers to undertake new safety tests once a drug is approved, so tracking the safety of drugs already on the market is the agency's responsibility … [T]he agency now relies almost entirely on the willingness of drug makers to report problems that crop up after a drug has been approved to ensure the safety of the nation's drug supply. Some critics say this dependency has gradually worn away at the agency's willingness to confront drug makers, making it timid and leaving patients vulnerable….”); see also Topol, Eric J., Failing the Public Health—Rofecoxib, Merck, and the FDA, 351 New Eng. J. Med. 1707 (2004)CrossRefGoogle Scholar.

216 Steinbrock, Robert, Waiting for Plan B—The FDA and Nonprescription Use of Emergency Contraception, 350 New Eng. J. Med. 2327 (2004)CrossRefGoogle Scholar (“The proposal to switch levonorgestrel emergency contraception (sold under the brand name Plan B [approved for prescription use in 1999]) to over-the-counter status in the United States is in limbo … In December 2003, the Nonprescription Drug Advisory Committee and the Advisory Committee for Reproductive Health Drugs, meeting in joint session, recommended that Plan B be switched from prescription to over-the-counter status; the vote was 23 to 4 … Political considerations—such as a desire to put the matter off until after the presidential election in November—have been the spoken and unspoken subtext of this decision.”); see also Kennedy, supra note 215 (“The [FDA] has had good advisory committees in the past. But the recent history of administrative removals, particularly that of COX-2 critic Curt Furberg from a panel considering those drugs, has invited public suspicion.”).

217 Krzyzanowska, Monika K. et al., Factors Associated with Failure to Publish Large Randomized Trials Presented at an Oncology Meeting, 290 JAMA 495 (2003)CrossRefGoogle ScholarPubMed (“A substantial number of large phase 3 trials presented an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Non-publication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards … [and] can lead to incorrect practice guidelines and inappropriate management of cancer patients.”).

218 21 U.S.C. § 355(b)(1)(A).

219 Meier, Barry, Glaxo to Begin Posting Drug Trial Results, N.Y. TIMES, Sept. 1, 2004Google ScholarPubMed at C2 (“GlaxoSmithKline is expected to begin posting online today the results of clinical trials on its drugs with the release of 65 tests about a diabetes medication, a company executive said yesterday … Recently, Eli Lilly also announced that it would create a public database of all its drug test results.”).

220 Dickersin, Kay & Rennie, Drummund, Registering Clinical Trials, 290 JAMA 516 (2003)CrossRefGoogle ScholarPubMed (“A comprehensive register of initiated clinical trials, with each trial assigned a unique identifier, would inform reviewers, physicians, and others (e.g., consumers) about which trials had been started and directly address the problem of publication bias … All stakeholders—investigators, research organizations and institutions, journal editors, lawmakers, consumers, and others—must act now, together and in their own domains, to ensure comprehensive registration of clinical trials.”); DeAngelis, Catherine D. et al., Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors, 292 JAMA 1363 (2004)CrossRefGoogle ScholarPubMed (“Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials … Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance that goal.”); see also Rennie, Drummond, Trial Registration: A Great Idea Switches form Ignored to Irresistible, 292 JAMA 1259 (2004)CrossRefGoogle Scholar.

221 People v. Collins, 438 P.2d 33, 40 (Cal. 1968).

222 COMMITTEE ON THE FRAMEWORK FOR EVALUATING THE SAFETY OF DIETARY SUPPLEMENTS, INSTITUTE OF MEDICINE & NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES, DIETARY SUPPLEMENTS: A FRAMEWORK FOR EVALUATING SAFETY (2005).

223 Id. at xi (“Although evaluation of data regarding the efficacy of such ingredients to maintain health is of interest to many, a review of these data was specifically not included in the charge to the committee” (emphasis added)).

224 Id. at 15.

225 Id.

226 Id. at 16

227 Id. at 17.