Opinion ID: 1495900
Heading Depth: 2
Heading Rank: 1

Heading: Regulation of Chelation Therapy by the Board.

Text: Chelation therapy has been approved by the federal Food and Drug Administration (FDA) only as a means for the removal of heavy metals from the body. However, non-FDA-approved, or off-label, use of medications by physicians is not prohibited by the FDA and is generally accepted in the medical profession. See 21 U.S.C. Sec. 396 (2000); Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350-51 & n. 5, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Approximately 1,000 physicians in the United States engage in the off-label use of chelation therapy to treat atherosclerosis and other vascular conditions. [4] Of these 1,000 United States-based physicians, 750 belong to the American College for Advancement in Medicine (ACAM), which has 1,000 members worldwide and which endorsed chelation therapy as a valid course of treatment for occlusive vascular and degenerative diseases associated with aging. [5] To that end, ACAM developed a protocol, followed by Dr. McDonagh, for using chelation therapy to treat such diseases. In 1989, the Board made an in-depth study of the efficacy of chelation therapy, but did not thereafter adopt any rules, regulations, or position papers on the use of this therapy. Then, in 1992 and 1994, two controlled studies were published that suggested that chelation therapy was ineffective in treating vascular disease. [6] Dr. McDonagh disputes the validity of these studies. But, after the publication of the studies, the American Medical Association (AMA) adopted a position statement on chelation therapy, declaring that: (1) [t]here is no scientific documentation that the use of chelation therapy is effective in the treatment of cardiovascular disease, atherosclerosis, rheumatoid arthritis, and cancer; (2) chelation therapy proponents should conduct controlled studies and adhere to FDA research guidelines if they want the therapy to be accepted more broadly; and (3) [t]he AMA believes that chelation therapy for atherosclerosis is an experimental process without proven efficacy. AMA, AMA Policy Compendium H-175.994, H-175.997 (1994). In spite of these developments, neither the FDA, the AMA, or the Board banned the use of chelation therapy to treat vascular disease, and Dr. McDonagh continued to prescribe and administer the therapy in his practice. Effective October 30, 2001, the Board adopted a rule stating that chelation therapy was of no medical value but that it would not seek to discipline a physician for using it on a patient from whom appropriate informed consent is received: (1) Pursuant to authority granted to the board by section 334.100.2(4)(f), RSMo, the board declares the use of ethylinediaminetetracetic acid (EDTA) chelation on a patient is of no medical or osteopathic value except for those uses approved by the Food and Drug Administration (FDA) by federal regulation. (2) The board shall not seek disciplinary action against a licensee based solely upon a non-approved use of EDTA chelation if the licensee has the patient sign the Informed Consent for EDTA Chelation Therapy form, included herein, before beginning the non-approved use of EDTA chelation on a patient. 4 CSR 150-2.165.