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McDonagh96-2543HA.WCR

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McDonagh96-2543HA.WCR

    Before the

    Administrative Hearing Commission

    State of Missouri

STATE BOARD OF REGISTRATION )

    FOR THE HEALING ARTS, )

     )

     Petitioner, )

     )

     vs. ) No. 96-2543 HA

     )

    EDWARD W. McDONAGH, D.O., )

     )

     Respondent. )

    FINDINGS OF FACT AND CONCLUSIONS OF LAW

     On December 6, 1996, the State Board of Registration for the Healing Arts filed a complaint seeking this Commission‘s determination that the medical license of Edward W. McDonagh, D.O., is subject to discipline for treating patients with chelation therapy, for failing to keep adequate records, for delegating professional responsibilities to people who were not qualified to perform those responsibilities, and for substandard care of patients.

     This Commission convened a hearing on the complaint on November 12, 13, 14, 17, 18, 19, 20, and 21, 1997. Glenn Bradford and Edward Walsh, with Glenn E. Bradford & Associates, P.C., represented the Board. Lori J. Levine and Max Humphreys, with Carson & Coil, P.C., represented McDonagh. Gregory D. Seeley, with Seeley, Savidge & Aussem, appeared pro hac vice to represent McDonagh.

     The parties elected to file written arguments. The matter became ready for our decision on June 11, 1999, when the last documents in the case were filed.

    Findings of Fact

    1. Edward W. McDonagh, D.O., is licensed as an osteopathic physician and surgeon, License No. DO27972. Such license is, and was at all times relevant, current and active.

    2. McDonagh was certified by the American Osteopathic Board of Family Physicians in 1974 and was recertified by testing in 1995. He is certified by and is a diplomate and fellow

    he American Board of Chelation Therapy. in t

    3. McDonagh practices primarily in the area of family medicine at 2800-A Kendallwood Parkway, Gladstone, Missouri, 64119.

    4. McDonagh became interested in chelation therapy and other alternative medical treatments in 1962.

    5. In McDonagh‘s practice, it is standard policy that every patient‘s records are

    1 Records are not always sent as requested. requested on the date of the first visit.

    26. McDonagh never dissuades his patients from seeing other doctors or specialists.

    7. The Health Care Finance Administration has set forth standards for Medicaid patients‘ medical records, but no Missouri law or regulation sets forth standards or recommendations.

    Count I

    8. Ethylene Diamine Tetra-Acetic Acid (EDTA) is a synthetic amino acid that was invented in the 1930s. In EDTA chelation therapy, the EDTA is administered by IV infusion. It wraps around divalent and trivalent ions in the body (chelatee), such as calcium, iron,

     1Tr. at 1137.

     2Id. at 866.

     2

    3 When the magnesium, and manganese, in order to make the resultant complex inactive.

    chelator EDTA combines with the chelatee, it forms a complex that is eliminated from the body through the urine. Early treatments with chelation therapy carried a risk of kidney disorder or death from renal failure because of the high levels of EDTA used in a short period of time.

    9. The Food and Drug Administration (FDA) has approved EDTA chelation therapy for the removal of heavy metals from the body, which is necessary in the case of lead poisoning

    4 The American Osteopathic Association, the American Heart Association, or hemocromatosis.

    the American College of Cardiology, and the American Medical Society do not endorse

    5chelation therapy for any purpose other than the removal of heavy metals. Medicaid and

    approximately 80% of insurance companies will not reimburse for chelation therapy for any purpose other than the removal of heavy metals.

    10. The Missouri Board of Healing Arts has no rule, regulation, or position paper

    6concerning chelation therapy. The Board studied the issue as early as 1984, and on November

    1989, the Board issued a public statement providing that it chose ―at this time to take no action concerning chelation therapy‖ and stated that ―as cases arise the Board will consider them on a

    7case by case basis[.]‖

     3―Chelate‖ is defined as follows: ―to combine with a metal in complexes in which the metal is part of a ring. By extension, a chemical compound in which a metallic ion is sequestered and firmly bound into a ring within ththe chelating molecule.‖ DORLAND‘S MEDICAL DICTIONARY 312 (27 ed. 1988). Chelate is ―derived from the

    Greek word chele which refers to the claw of a crab or a lobster, implying the firm, pincer-like binding action of certain chemical substances to a metal ion. . . . Chelation is specifically defined as the incorporation of a metal ion into a heterocyclic ring structure.‖ (Resp. Ex. A-2, at 5.)

     4A metabolic disorder ―due to deposition of [iron-containing pigments] in the parenchymal cells, causing

    tissue damage and dysfunction of the liver, pancreas, heart and pituitary.‖ DORLAND‘S, at 747.

     5Tr. at 914-918; Pet‘r Ex. 24-28.

     6Tr. at 523.

     7Resp. Ex. B-1, at 1, 3-4.

     3

    11. There is no law in Missouri that prohibits the use of chelation therapy for any purpose.

    12. When a doctor uses a medicine or therapy that has been approved for one use for a different use, it is called ―off-label‖ use. Off-label use of a drug or treatment is not per se illegal

    8or improper. Several state statutes require insurance companies to provide coverage for certain

    9off-label uses such as cancer treatment.

    13. There are many drugs currently used in which the mechanism of the drug‘s action

    10within the body is unknown.

    14. McDonagh has used EDTA chelation therapy to treat atherosclerosis and other vascular diseases since the early 1960s (all future references to EDTA chelation therapy will refer to its off-label use unless otherwise noted).

    15. The American College for Advancement in Medicine (ACAM) is an organization of

    11approximately 1,000 physicians worldwide. The ACAM‘s position is that chelation therapy is

    a valid course of treatment for occlusive vascular disease and degenerative diseases associated with aging, such as diabetes and rheumatoid arthritis.

    16. McDonagh has all patients sign a consent to medical treatment and agreement concerning chelation therapy that discusses the positive and negative aspects of chelation therapy

     8Resp. Ex. G-2; Soffer Depo. Tr. at 50, 69-73. Doctors who prescribed aspirin for cardiovascular problems before the FDA gave approval for that use were prescribing off-label. (Soffer Depo. Tr. at 70-73.) The Board‘s

    expert, Dr. David G. Meyers, testified that he has never prescribed beyond the package insert. (Tr. at 397.)

     9Conn. Gen. Stat. Ann. ?? 38a-492b and 518b; R.I. Gen. Laws ? 27-55-2(a); Ala. Code ? 27-1.10.1.

     10Tr. at 399.

     11Tr. at 589. McDonagh‘s expert, Dr. Charles Rudolph, estimates the percentage of chelation therapists as 2% of doctors. (Tr. at 1255.)

     4

    12 The notice given to all patients states that chelation therapy is not and possible side effects.

    approved by the AMA, the FDA and others. The notice lists benefits that may be derived from treatment, but states, ―however, you must be aware that you may not receive all of these benefits

    13as they do not occur predictably with every patient and in some cases may not occur at all.‖

    Many patients go to McDonagh specifically for chelation therapy. He tells his patients that the therapy does not work on everyone and that the treatment will work better if the patient follows the diet, exercise and nutritional supplements that are recommended. McDonagh does not perform chelation therapy without informed consent from the patient.

    17. Several states have passed laws allowing a doctor to perform any procedure on any

    14patient who consents to it as long as the patient gives informed consent.

    18. When used at the dosage levels recommended to chelation therapists, chelation

    15therapy is not dangerous to patients.

    19. Other alternative treatments for cardiac disorders have been shown to be effective,

    16but carry certain risks associated with them. In cardiac bypass surgery, there is an operative

    mortality rate of 2%, as high as 25-30% in some areas of the United States, and as high as 35%

    17in China. Mental impairment occurs in as many as 18% of cardiac bypass patients.

     12Resp. Ex. F-2, F-3.

     13Pet‘r Ex. 2 at 2.

     14Sampson Depo. Tr. at 87. See Ariz. Rev. Stat. Ann. section 32.1401 (requirements for use of chelation

    therapy).

     15Tr. at 169. Dr. Wallace Sampson testified that he knew of no deaths that resulted from the three-gram dose of chelation therapy. He noted a case report in which the patient suffered from branch retinal artery occlusion, but was unable to determine the dosage given. (Sampson Depo. Tr. at 67-71.) Dr. Alfred Soffer testified that he knew of no deaths that had been reported due to chelation therapy when given according to protocol. He stated that there are reported side effects one out of 200 times when a needle is inserted into the body, but this is a general statistic for any IV injection and is not specific to chelation therapy. (Soffer Depo. Tr. at 122-24.)

     16Soffer Depo. Tr. at 121-22; Resp. Ex. A-1 at 145-56.

     17Tr. at 647-48.

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    Angioplasty has an operative mortality of 1%; however, in the case of angioplasty, the patients can have a heart attack or a ruptured blood vessel. ―Theoretically angioplasty should never be done anyplace unless they‘re all prepared to do a bypass surgery immediately and to repair the

    18 blood vessel broken.‖

    A. Chelation Therapy Studies

    20. In order to determine whether a drug is effective for a particular purpose, there are

    19several levels of observations or experiments. The lowest level is the case report, in which a

    doctor notes something that he or she has observed concerning the drug or therapy. These usually involve one or only a few people and are uncontrolled. The case series, in which many of these case studies are considered together, is the next level. Next is the case control study, in which a doctor studies people with a particular disease and compares them to people who definitely do not have that disease. Next is the longitudinal study, where a group of people who took the drug or therapy is compared over a period of time to a group of people who did not. The clinical trial (double-blind study) is the highest level. People for the double-blind study are selected at random from a group with the problem sought to be treated (such as a group with angina). Then the decision is made at random which of the individuals will receive the medicine and which will receive a placebo (inactive substance). The patient does not know if he or she is receiving the medicine or the placebo.

     18Tr. at 652.

     19Id. at 88-106.

     6

    21. It would be unethical to perform a double-blind/placebo study for some medical

    20 The highest level of study possible for procedures, such as angioplasties and bypass surgeries.

    21bypass surgery and angioplasty is the randomized clinical trial that is not blinded. There is a

    difference of expert opinion as to whether it would be feasible or ethical to perform double-blind studies in chelation therapy. Dr. Meyers testified that there would be no ethical problem in doing so. McDonagh writes that he could not ethically perform a double-blind study using chelation therapy in private practice because it would be unethical to charge for placebo treatment, and the

    22group who were not getting charged would know that they were the placebo group. Unless the

    study is funded, the patient must pay for the therapy (which is not covered under most insurance companies). Therefore, the doctor could not charge for chelation therapy and give only placebos. In addition, there is a burning sensation associated with chelation and an unusual odor to the

    23patient‘s urine, which would indicate who is receiving the chelation therapy.

    22. Most studies in EDTA chelation therapy are of the case report or the longitudinal study type. Many case reports show patient improvement.

    23. In 1989, a study on EDTA chelation therapy was performed by Efrain Olszewer, M.D., Fuad Calil Sabbag, M.D., and James P. Carter, M.D., DrPH, in New Orleans, Louisiana (the Olszewer study). This study involved ten male patients (age range 41 to 53 years) with

     20The Board‘s expert, Dr. David G. Meyers, described the Vineburg Procedure experiment performed in the 1960s at the Cleveland Clinic prior to modern heart bypass surgery procedures. This experiment was designed to study a procedure in which the doctors removed an artery, cut off the end, and inserted it into the heart muscle. The doctors in this study performed the procedure on half of the patients, but for the other half, they operated but performed no procedure. Today, this would be considered unethical. (Tr. at 109.) He stated that it would also be improper to do a controlled, double-blind study of angioplasty. (Tr. at 109-110.) Dr. Soffer also testified that it is not always possible to do a double-blind study. (Soffer Depo. Tr. at 78, 93.)

     21Tr. at 113.

     22Resp. Ex. C-1 at 28.

     23Tr. at 631, 1351.

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     24 who ―peripheral vascular disease from diabetes or arteriosclerosis, aggravated by smoking,‖were randomly selected. The study began as a double-blind study in which the ten patients were randomly divided into two groups and were given EDTA or distilled water. After ten treatments,

    25one group was improving rapidly, and the doctors ―decided to break the code.‖ They

    determined that only the patients receiving EDTA were improving, and they proceeded as a single-blind test so that they could ethically treat all patients for the remaining ten treatments. The study showed improvement with the EDTA chelation therapy. The majority of the medical community does not accept this study because the experiment was not totally blinded, there were

    26few patients, the measurements they used for improvement were not precise, and it was not

    replicated by another investigator.

    24. In 1992, B. Guldager, R. Jelnes, S.J. Jorgensen, J.S. Nielsen, A. Klaerke, K. Mogensen, K.E. Larsen, E. Reimer, J. Holm, and S. Ottensen published a double-blind/placebo

    27study (the Guldager study). In this study, 153 patients (all more than 40 years of age who had

    28suffered from stable intermittent claudication for at least 12 months) received 20 intravenous

    infusions of the EDTA or placebo for five to nine weeks. The study measured the pain-free walking distance, the maximum walking distance, the ankle/brachial blood pressure index, and the systemic and ankle blood pressures. The experimenters performed subjective evaluations

     24Resp. Ex. G-15 at 171.

     25Id. at 173.

     26The study measured peripheral vascular signs (skin disturbances, temperature, hair changes), kidney function, blood pressure (BP) and BP index, a Walking Test, a Master ―Two Step‖ Exercise Test and a Bicycle Stress Test. (Resp. Ex. G-15 at 172.)

     27159 patients were recruited for the study, and 153 patients completed the treatment period. (Pet‘r Ex. 15,

    Ex. F to Green Depo. Tr. at 267.)

     28Absence of pain when a limb is at rest, but pain, tension and weakness upon exercise. DORLAND‘S, at 343.

     8

    and laboratory tests, and investigated the possibility of side effects. The study found that EDTA chelation therapy was not more effective than a placebo in treating intermittent claudication.

    25. The majority of the medical community accepts the Guldager study. Proponents of chelation therapy (chelation therapists) do not accept this study because the patients were able to determine whether they were in the placebo group or the chelation therapy group because

    29c helation therapy causes some pain at the point of insertion, and placebo treatment does not.Chelation therapists argue that the patients were even told whether they were getting a placebo or

    30chelation therapy and that the bottles were mixed up. Chelation therapists also question

    whether those who conducted the study were neutral and objective because they were vascular

    31surgeons who benefited from an unsuccessful study. The patients were given iron, which

    chelation therapists maintain was an error because one of the reasons to give chelation therapy is to remove iron from the body. Iron causes the occurrence of free radical reactions, which

    32chelation therapists assert causes heart disease. Some patients in the Guldager study continued

    smoking, which is a significant risk factor for heart disease. In addition, smokers would require

    33more chelation treatments to realize benefits. Chelation therapists argue that patients were

    instructed to start their own IVs and that 30% of the subjects had infections because the needles

    34were left in place.

     29Dr. Soffer testified that it is possible to mimic the side effects of chelation therapy by using magnesium. (Soffer Depo. Tr. at 78.)

     30Tr. at 627-28.

     31Frackelton described the Sloth-Neilson study performed by one of the authors of the Guldager study, which he argues shows bias. (Tr. at 618-21.)

     32The ACAM Protocol warns against giving patients iron unless they are initially deficient, stating, ―A major

    benefit of chelation is the removal of unwanted accumulations of freely catalytic, unbound iron.‖ (Pet‘r Ex. 11 at 11.)

     33Tr. at 629.

     34Id. at 628.

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    26. In 1994, van Rij published a double-blind random study of 32 patients with intermittent claudication (the van Rij study). In this study, the patients received 20 treatments of chelation therapy or placebo twice per week for a period of ten weeks. The study compared upper extremity and lower extremity blood pressures, walking on a treadmill, blood flow in the skin, how much oxygen got into the skin, and pulse volume. The study investigated attitudes related to lifestyle. Using their six endpoint measures, the study found no difference between the

    35 two groups.

    27. The majority of the medical community accepts the van Rij study. Chelation therapists find the following flaws with this study: not all the patients stopped smoking, only 20

    36treatments were given (instead of 30) for very severe, terminally ill vascular patients. They

    also find fault with the interpretation of the statistical data because one patient in the placebo

    3738group was an ―outlier‖and his data was not discarded. Dr. Frackelton testified that if

    39discarded, there is clear improvement in the chelation group over the control group. The

    control group was also given magnesium, vitamin C, and other vitamins (ingredients in chelation therapy except EDTA), which could have had a beneficial effect on the patients; thus, it was not

    40a true placebo test.

    28. From 1981 to 1994, a small number of doctors including Dr. Rudolph published abstracts in journals such as the Journal of Advancement in Medicine, the Journal of the

     35Tr. at 126.

     36Id. at 635.

     37Without explanation, one patient in the placebo group did very well on the tests. (Tr. at 636-37.)

     38Dr. Frackelton testified that such data is often discarded in statistical studies. (Tr. at 637.)

     39Tr. at 636-37.

     40Soffer Depo. Tr. at 85-89.

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