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FLORIDA NUTRITION COUNSELORS ASSOCIATION vs BOARD OF MEDICINE, DIETETICS AND NUTRITION PRACTICE COUNCIL, 93-000244RP (1993)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jan. 21, 1993 Number: 93-000244RP Latest Update: Jan. 22, 1996

The Issue The issue for consideration in this hearing is whether the Board of Medicine's proposed amendments to Rules 21M-49.002(6), 21M-50.002(3)(f) and (j), 21M-50.003(1), 21M-50.007(3) and (18), and 21M-50.009(1), F.A.C., are invalid because of being vague and an invalid exercise of delegated legislative authority.

Findings Of Fact At all times pertinent to the issues herein, the Florida Board of Medicine, (Board), was the state agency responsible for the licensing of medical professionals and the regulation of the medical profession in Florida. A sub- agency of the Board is the Dietetics and Nutrition Practice Council, (Council). The Council is the agency which drafted and initially promulgated the proposed rule amendments herein concerned, though the Board is ultimately responsible for the final promulgation of the rules and amendments thereto. The Florida Nutrition Counselors Association is an organization of approximately 150 Florida-licensed health care practitioners. No evidence was produced by either party to indicate how many individuals are licensed as nutrition counselors in this state or how many practitioners of that profession may be substantially affected by the proposed rule amendments. The Council was established in 1989, and since that time has been concerned with licensure issues regarding dietitians, nutritionists and nutrition counselors. Over the intervening years the Council became concerned that some nutrition counselors might be practicing outside the permissible parameters of their specialty and as a result, the Board directed the Council to draft proposed rules designed to insure the proper practice of that profession. Thereafter, workshops were held to solicit public input and collect documents to be used in the drafting of the proposed rules and amendments to existing rules. There is no allegation that the rule-making methodology followed by the Council was either inappropriate or unlawful and it is found that the process followed was lawful. As the drafting process continued, though no members of the Association were represented on the Council, Association members were afforded the opportunity to and did participate and/or observe. Much of the preliminary activity of the Council consisted of surveying the scientific community to identify the prevailing standards for the practice of nutrition. Encompassed within the framework of the National Nutritional Foods Association is a trade association for health food and supplement retailers and nutrition counselors. This organization, known as SoHo, has been involved in the legislative process relating to the practice of nutrition and dietetics in Florida for several years. Representatives of this organization were present during a portion of the rule-making process and were afforded the opportunity to discuss the possible economic impact the proposed rules and amendments would have on its membership. It was determined this effect would be minimal and this determination was made known to Petitioner by letter from counsel for the Board to counsel for Petitioner. In addition, Petitioner was invited to submit input on this issue before a joint session of the Board and Council but failed to do so. Therefore, the aforementioned letter from counsel was adopted as the economic impact statement. Whereas the legislature has recognized that the practice of dietetics and nutrition by unskilled and incompetent practitioners presents a danger to the public health and safety it has not, itself, set any standards for that practice. Instead, it has authorized the Board of Medicine and the Council to adopt rules to implement such standards in furtherance of the legislative purpose to protect the public. In some instances, the proposed rule amendments would prohibit or interfere with the currently existing practices of some nutrition counselors. In that regard, it should be noted that many nutrition counselors were licensed under a grandfather provision without examination or other means of establishing qualification to practice. Nutrition counseling is an emerging profession. Its orientation is to promote the health of people though nutrition. There are, currently, no national organizations for nutrition counselors and only twelve states require them to be licensed. Nutrition counselors, generally, perform an assessment of a client's nutritional condition and, thereafter, suggest foods or food supplements to provide for or rectify any deficiencies identified. Nutrition counselling can also be an educational tool, but the bona fide nutrition counselor does not prescribe items designed to cure conditions. Dietitians make up a much more established profession whose orientation is the delivery of foods, planning menus, institutional food service, recipe development and the quantitative analyses of foods. Having developed out of the home economics programs at university level, they are well organized nationally through the American Dietetic Association, and in Florida through the Florida Dietetics Association. As opposed to nutrition counselors, who perform in a community setting, dieticians work in a more clinical setting. Both are ancillary health professionals who work both with a physician and independently. There are many methods used to perform a nutrition assessment, but for the most part, all include the taking of simple measurements of the client's height, weight, mid-arm circumference, blood serum, albumin and serum transferrin, and a history of the client's diet and life-style. It is common for the nutrition counselor to have the client obtain a blood and urine test through a physician. Some practitioners utilize such procedures as hair analysis, biological ionization, herbology or iridology. All are non-invasive. These latter procedures are not well recognized in the mainstream of nutrition and dietetics, however, and are considered, by the mainstream medical and dietetics professionals, not to be standard tests for nutrition assessments. The major thrust of nutrition counseling is the improvement of nutritional intake and it is entirely appropriate for the nutrition counselor to confer with the client's physician to obtain information about medical conditions and medications being taken, and to seek the physician's assistance by ordering laboratory testing. The term, "nutrition counselor" is but a title. The practice of nutrition counseling is a technique utilized within the parameters of the broader field of nutrition. Both nutritionists and nutrition counselors provide counsel and are bound by appropriate standards for counseling. The proposed amendment to Rule 21M-49.002(6), which outlines those activities prohibited to nutrition counselors refers to such proscribed activities as diagnosis, treatment, operation, prescription for disease, pain, injury, deformity other physical or mental condition. The proposed amendment adopts the practice of medicine definition as outlined in Florida Statutes. Diagnosis is the identification of or the ruling out of specific disease states. Nutrition counselors do not diagnose disease, pain or injury. Identification of nutritional deficiencies and the recommendation of specific foods of food supplements to correct those nutritional deficiencies do not constitute the diagnosis, or treatment prohibited by the proposal. Assessment of physical and mental conditions, however, closely approaches diagnosis which is the sole purview of the physician. If a physician diagnoses a physical condition and identifies the cause thereof, and thereafter refers the patient to a nutrition counselor for development of a dietary plan, the counselor may, within those parameters, work with the client to develop a diet and supplement plan consistent with the physician's diagnosis and recommended treatment. Proposed amendment to Rule 21M-50.002(3), relating to fraudulent, false, deceptive or misleading advertising, prohibits reference to questionable methods of assessment or treatment or treatment which is experimental or without generally accepted scientific validation. As with any other science, experimentation is an acceptable part of research but it must always be conducted only under strictly regulated conditions, and only physicians may carry on patient experimentation. Patient experimentation is not a part of the scope and practice of nutrition counseling as defined by the Dietetics and Nutrition Practice Act. As mentioned previously, some nutrition counselors utilize certain procedures which are not accepted as valid by the more established medical and nutrition communities. These may include hair analysis, iridology, blood ionization and herbology, and have been characterized by some in the scientific community as "questionable methods." "Questionable methods" and "generally accepted scientific validation" are phrases which have a generally accepted meaning within the scientific community. In general, the latter refers to those principles and that pertinent information which has been effectively tested by qualified evaluators against known standards and validated by results found to be routinely consistent and reliable. This is neither difficult to understand or to follow. Proposed Rule amendment 21M-50.007(3) restricts the practice of nutrition counseling to generally accepted scientific principles and current information. To be sure, there is a plethora of information and procedures which exists on the periphery of established science and for which there is a fund of supporting information and a host of advocates. When tested in scientific evaluation against known standards and analyzed statistically for acceptance within the scientific community, this information and these procedures are usually found to be insufficiently supported and generally unaccepted in the better practice of nutrition and dietetics. Proposed Rule 21M-50.007(18) suggests, by the use of the operative word, "should", that nutrition counselors police themselves by upholding their standards for professional practice and by reporting violations to the Council, the Board, and the Department. While this provision is not mandatory, it is expected to be followed. Petitioners object to it as unnecessary and as having the potential for subjecting one practitioner to discipline because of the misconduct of another. As proposed, it is inartful, vague, and, conceivably, unenforceable. Petitioners also object to the provisions of Proposed Rule 21M- 50.009(1) which prohibits the use of instruments, devices or treatments not regularly taught in a recognized college or university. In that regard, most colleges do not treat extensively upon the subject of nutrition counseling which is, to a large extent, ignored by the mainstream medical profession. Most nutrition counseling techniques are taught at workshops and seminars and in apprenticeships. For this reason and because of their belief that the proposed rule does not accurately reflect the current standard of practice in the profession, Petitioners object to it. Little, if any, evidence in support of this position was set forth, however. Proposed Rule 21M-50.009(1) also lists those procedures which are prohibited to the practice of nutrition counseling and which include biological ionization, biomagnetic devices, cytoloxic testing, hair analysis, herbology, homeopathy, iridology, nutropathy, and oxidation/ionization devices or psychotronics-radiation devices. Those in issue here are herbology, iridology, hair analysis and biological ionization. Petitioners have abandoned their challenge to the remainder. Herbology is not an assessment tool but a modality. It comes closest to being classified as current information within the definition of the proposed rules. Iridology, which is an analysis of the human condition through examination of the iris, is considered by the Board to be within the parameters of the practice of medicine. It is non-invasive and has not been shown to cause physical harm. It is an assessment technique but not a diagnostic tool, a cure or treatment. It is designed to show cholesterol and body acid levels, but it is, however, felt to be unproven and bordering on quackery by the mainstream medical profession whether accomplished by a medical doctor or a nutrition counselor. Hair analysis, a procedure utilized by an unknown number of Association members, including its President, involves the analysis of hair samples taken from the client to determine the presence of trace minerals, and as a toxic metal screen. Though used in criminology and by the Environmental Protection Agency to detect toxic metal exposure in environmental enforcement, hair analysis is not mainstream practice and it can be influenced by numerous outside factors, including hair dye and other preparations, the age of the sample, and the like. Hair is considered a tissue sample which, under Florida law, can be submitted to a properly licensed clinical laboratory only by appropriately licensed persons. Nutrition counselors do not fall within this category. Hair analysis is not invasive nor is the gathering of hair for analysis. Most clinical laboratories recognize approximately 2,000 laboratory tests. Hair analysis in not one of them. While there are many licensed clinical laboratories in this state, only eight laboratories, nationwide, do hair analysis. None are in Florida except for laboratories which perform analysis of hair samples for forensic purposes. In biological ionization, used in conjunction with iridology, urine and saliva samples are provided by the client and are measured for ph factor. While this procedure is done by an unknown number of Association members, it is not considered by the medical profession to be an acceptable assessment.

Florida Laws (11) 120.52120.56120.57455.201458.305468.501468.502468.503468.507468.51468.518
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REBECCA RILEY vs. NASSAU GENERAL HOSPITAL, 87-003625 (1987)
Division of Administrative Hearings, Florida Number: 87-003625 Latest Update: May 11, 1988

The Issue The basic issue in this case is whether the Respondent discriminated against the Petitioner on the basis of her race and thereby engaged in an unfair employment practice within the meaning of Section 760.10, Florida Statutes. The Petitioner asserts that she was discriminated against by the employer's failure to promote her. The Respondent denies any discrimination. At the hearing, both parties presented the testimony of witnesses and offered documentary exhibits. Subsequent to the hearing a transcript of the proceedings was prepared and filed. Pursuant to agreement of the parties, their proposed recommended orders were originally due by no later than February 1, 1988. At the request of the Petitioner, for good cause shown, the filing date was twice extended. On March 21, 1988, both parties filed timely proposed recommended orders containing proposed findings of fact and conclusions of law. The Respondent also filed a supporting brief. The post-hearing submissions of the parties have been carefully considered in the formulation of this recommended order. Specific rulings on all findings of fact submitted by all parties are contained in the Appendix which is attached to and incorporated into this recommended order.

Findings Of Fact Based on the stipulations of the parties, on the testimony of the witnesses, and on the exhibits received in evidence, I make the following findings of fact. The Petitioner, Rebecca Riley, a black female, began work at Nassau General Hospital in 1971 as a dietary aide or "salad girl." Currently, the Petitioner is employed by the Respondent as a cook. Petitioner's first supervisor was Ms. Hazel Adams. Ms. Adams was a white female. Ms. Adams was food service manager from the time the Petitioner was hired in 1971 until 1980. Ms. Adams became ill in 1975 and was eventually forced to leave her job at Nassau General in 1980 due to her failing health. During the latter part of 1979, the Respondent entered into a management contract with Methodist Regional Hospital Systems to provide new management for the hospital. As part of the new management team, Mr. Ronald Rice was hired by Methodist Regional Hospital Systems to be the new hospital administrator. Mr. Rice served in that capacity from 1980 until 1985. Mr. Rice was well qualified for that position by formal education and prior experience. When Mr. Rice began his employment as administrator, the Respondent hospital had a large number of management and financial problems which it was hoped the new management could resolve. When Ms. Adams left in 1980, Ms. Delia Boynt partially assumed the duties of food service manager. Ms. Boynt also had a severe health problem. Ms. Boynt was a white female. In August of 1981, Ms. Barbara Fletcher became consulting dietician to the hospital. Ms. Fletcher initially worked 8 hours per week, but as Ms. Boynt became progressively more ill, Ms. Fletcher started assuming the duties of food service manager, including doing the kitchen-paperwork, ordering food, and evaluating employees. With the passage of time, Ms. Fletcher's hours increased from 8 to 20 hours per week. Ms. Boynt left the hospital in September of 1982. At that time, Ms. Fletcher was working 20 hours a week as food service manager. Ms. Fletcher was concerned that when she left work each day at noon, there was no one left to function in a supervisory capacity in the kitchen. Because of this concern, Ms. Fletcher approached Mr. Rice concerning the creation of a head cook position. The head cook position would be primarily responsible for taking care of any problems that came about during the time when Ms. Fletcher was not at work. Also, the head cook would be responsible for checking in food received from vendors, performing inventories each month, ordering food, and cooking. When Ms. Fletcher made the suggestion to Mr. Rice concerning the creation of the head cook position, she intended to continue to function as the food service manager. Ms. Fletcher suggested to Mr. Rice that the head cook position be offered to all three of the cooks. In September of 1982, the cooks in the kitchen at the respondent hospital were Eddie Melton, Elizabeth Fullwood, and the Petitioner. When Ms. Fletcher offered the head cook position to Ms. Melton, Ms. Melton declined the position. The Petitioner expressed an interest in the position, as did Ms. Fullwood, who had been working at the hospital since August of 1981. Ms. Fletcher decided the best way to choose between the Petitioner and Ms. Fullwood would be to develop a test to determine which employee was more qualified. However, before Ms. Fletcher could develop the test, Ms. Fullwood approached her and informed her that she felt that the other employees in the kitchen would make a racial issue out of her pursuit of the job as head cook. Consequently, Ms. Fullwood withdrew her name from consideration for the head cook position. Ms. Fullwood is a white female. In 1982, all of the other nonsupervisory employees in the hospital kitchen were black. Ms. Fletcher then offered the head cook job to the Petitioner, who accepted the job. The Petitioner served as the head cook for only a very few days. After working as head cook for just a very few days, the Petitioner informed Ms. Fletcher that she did not feel that the job was worth the money she was to be paid and that Ms. Fletcher could have the job back. Upon the Petitioner's relinquishment of the head cook position, Ms. Fletcher approached Ms. Fullwood, the only remaining cook who had expressed an interest in the head cook position, and offered her the job. Ms. Fullwood still had reservations about accepting the job and spoke to the Petitioner to ensure that there would be no "hard feelings" if Ms. Fullwood were to accept the job. Having determined that there would be no hard feelings, Ms. Fullwood accepted the position of head cook on or about October 1, 1982. At this time, Ms. Fletcher still intended to continue to function as the hospital's food service manager. In mid-October of 1982, Ms. Fletcher experienced some domestic problems which resulted in her giving notice that she would be quitting her employment at the hospital. Her last day of employment was October 29, 1982. Because of Ms. Fletcher's notice that she would be leaving, it became incumbent upon Mr. Rice to hire a food service manager. The Florida Department of Health and Rehabilitative Services license standards for hospitals require a designated food service manager. Mr. Rice initiated the process of selecting a new food service manager by informing Cathy Fox, Ms. Fletcher's replacement as consulting dietician, that the hospital was required to hire a food service manager. At the same time, Mr. Rice asked Ms. Fox to draft a new job description for the position of food service manager. Mr. Rice wanted to upgrade all the job descriptions at the hospital for purposes of satisfying the Joint Commission on Accreditation. Joann Robinson, personnel director at Nassau General at that time, also had input into the drafting of the job description. The job description Ms. Fox developed required that the food service manager be: high school graduate with at least 2-3 years management experience in food service, or a 2 year food service technology course plus one year experience in food service management, or a 4 year college degree in Institutional Food Service Management. Mr. Rice also contacted Danny Bellford at the Job Corps and asked Mr. Bellford to recommend local people for the job of food service manager. The Job Corps sent two candidates for the position of food service manager to the hospital. Ms. Fox interviewed these two individuals and determined that neither of them was qualified. It was common knowledge throughout the hospital in mid-October 1982 that the position of food service manager was available. Ms. Fullwood, head cook at that time, approached Mr. Rice in his office and informed him that she was interested in the position. The Petitioner also expressed an interest in the position during a conversation held with Mr. Rice in the cafeteria. Thus, the two candidates from whom a food service manager would be selected were Ms. Fullwood and the Petitioner. Ms. Fox made the recommendation that Ms. Fullwood receive the position of food service manger. Mr. Rice accepted Ms. Fox's recommendation of Ms. Fullwood based upon his review of both the Petitioner's and Mrs. Fullwood's applications and Ms. Fullwood's superior qualifications. Upon comparing Ms. Fullwood's qualifications to the Petitioner's qualifications, it was obvious that Ms. Fullwood was clearly the better qualified candidate. Ms. Fullwood met all of the requirements in the job description. The Petitioner did not meet all of those requirements because the Petitioner did not have a high school diploma and did not have any management experience in food service. Ms. Fullwood had a GED certificate, had five years of experience as an assistant manager supervising three employees in a school food service position, and had successfully completed numerous courses regarding food service and food service management. At most, the Petitioner completed only one course related to her job, even though given opportunities to take other courses. In light of the superior qualifications of Ms. Fullwood, Mr. Rice approved Ms. Fox's recommendation of Ms. Fullwood for the position of food service manager. Mr. Rice did not consider the Petitioner's race at any time in his decision to select Ms. Fullwood for the food service manager position. There is no persuasive evidence of any improper motivation in the selection of Ms. Fullwood rather than the Petitioner. Since the selection of Ms. Fullwood for the position of food service manager, the Petitioner has made no effort to obtain other employment in a supervisory position in any type of institutional food service facility.

Recommendation For all of the foregoing reasons, it is recommended that the Petition in this case be dismissed and that the relief sought by the Petitioner be denied. DONE AND ENTERED this 11th day of May, 1988, at Tallahassee, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of May, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-3625 The following are my specific rulings on all findings of fact proposed by all of the parties. Findings proposed by the Petitioner (The paragraphs of the Petitioner's proposed findings are not numbered. The ordinal numbers below correspond to the order of the paragraphs, with each indentation of the text of the proposals being treated as a new paragraph. For convenience, page numbers are also included.) First paragraph (page 1): First sentence rejected as statement of position rather than proposed finding of fact. Second, third, and fourth sentences rejected as subordinate and unnecessary details. Fifth sentence accepted. Sixth and seventh sentences rejected as subordinate and unnecessary details. Eighth and ninth sentences rejected as not supported by competent substantial evidence or contrary to the greater weight of the evidence. Second paragraph (page 1) : First three sentences accepted. Last sentence rejected as not supported by competent substantial evidence and, as in any event, irrelevant to the issues in this case. Third paragraph (pages 1-2): First sentence accepted in substance. Second sentence rejected as contrary to the greater weight of the evidence. Third sentence accepted in substance. Fourth sentence rejected as not supported by competent substantial evidence and as, in any event, irrelevant to the issues in this case. Fourth paragraph (page 2): Accepted. Fifth paragraph (page 2): Accepted in substance, with clarifying details added and editorial comments omitted. Sixth paragraph (page 2): Accepted in substance. Seventh paragraph (page 2): Accepted. Eighth paragraph (page 2): Accepted in substance. Ninth paragraph (page 3): First two sentences accepted in substance. Third sentence rejected as irrelevant because this was a "head cook" position, not a food service manager position. Last sentence rejected as unnecessary editorial comment. Tenth paragraph (page 3): First sentence rejected as contrary to the greater weight of the evidence. The remainder of this paragraph is rejected as irrelevant. Eleventh paragraph (page 3): First sentence accepted in substance. Second sentence rejected as contrary to the greater weight of the evidence. Parenthetical sentence accepted in substance. Last sentence rejected as not supported by persuasive competent substantial evidence. Twelfth paragraph (page 3): Rejected as unnecessary argument or editorial comment rather than proposed findings. To the extent it constitutes proposed findings of fact, it is cumulative and unnecessary. Thirteenth paragraph (page 3): Rejected as irrelevant to the issues in this case. Fourteenth paragraph (page 4): First sentence accepted, but in context with additional information about Fullwood's employment history. Second sentence rejected because it contains details contrary to the greater weight of the evidence. Fifteenth paragraph (page 4): First sentence rejected because it contains details contrary to the greater weight of the evidence. Second sentence rejected as irrelevant. Third sentence rejected as not supported by competent substantial evidence. Last four sentences rejected as procedural details. Findings proposed by Respondent Paragraphs 1 and 2: Accepted. Paragraph 3: Accepted in substance, with numerous unnecessary details omitted. Paragraph 4: Rejected as irrelevant to disposition of the issues in this case. Paragraphs 5, 6, 7, 8, 9, 10, and 11: Accepted. Paragraph 12: Rejected as unnecessary details. Paragraphs 13, 14, 15, 16, 17, 18, and 19: Accepted. Paragraphs 20, 21, 22, and 23: Accepted in substance, with numerous subordinate details omitted. Paragraph 24: Accepted. Paragraph 25: Rejected as subordinate and unnecessary details. Paragraph 26: Accepted. COPIES FURNISHED: Calvin Moore, Esquire 619 South 10th Street Fernandina Beach, Florida 32034 Mr. Johnell Preliou, President National Association for Advancement of Colored People Nassau County Branch Post Office Box 403 Fernandina Beach, Florida 32034-0403 Patrick D. Coleman, Esquire James M. Craig, Esquire Coffman, Coleman, Andrews & Grogan Post Office Box 40089 Jacksonville, Florida 32203 Dana Baird, General Counsel Florida Commission on Human Relations 325 John Knox Road Building F, Suite 240 Tallahassee, Florida 32399-1925 Donald A. Griffin, Executive Director Florida Commission on Human Relations 325 John Knox Road Building F, Suite 240 Tallahassee, Florida 32399-1925

Florida Laws (2) 120.57760.10
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BOARD OF MEDICINE vs JESSE BRANCALEONE, 96-003354 (1996)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Jul. 17, 1996 Number: 96-003354 Latest Update: Sep. 19, 1997

The Issue Whether Respondent, a licensed nutritional counselor, committed the offenses alleged in the administrative complaint and the penalties, if any, that should be imposed.

Findings Of Fact Petitioner is the state agency charged with regulating the practice of nutritional counseling pursuant to Section 20.42, Florida Statutes; Chapter 455, Florida Statutes, and Chapter 468, Florida Statutes. Respondent was licensed as a nutritional counselor at all times pertinent to this proceeding. Respondent was issued license number NC 0000427 in 1990. At the time of the formal hearing, Respondent’s address was 6661 Royal Palm Boulevard, Margate, Florida 33063-2108. At all times pertinent to this proceeding, C. B. was a female cancer patient of Franciso Bellette, M.D., a physician specializing in the field of oncology. Before Dr. Bellette moved to Florida in 1993, C. B. was treated by another physician in the practice group that Dr. Bellette subsequently joined. Prior to 1993, C. B. had chemotherapy, which she tolerated poorly. In October 1995, Dr. Bellette diagnosed C. B. as having Stage 4 breast cancer with bony metastasis. Although the preferred treatment was chemotherapy, C. B. refused further chemotherapy because of her poor prior experience with chemotherapy. As the alternative treatment, Dr. Bellette prescribed the drug Tamoxifen for C. B., and she began taking that medicine. Tamoxifen has been used to treat cancer patients for several years. There are documented side effects and risks associated with taking the drug. Dr. Bellette was aware of those side effects and risks and explained them to C. B. before she began taking Tamoxifen. It was Dr. Bellette’s opinion that for C. B. the benefits of taking Tamoxifen outweighed the known side effects and risks. In January 1996, C. B. traveled to Mexico to investigate an alternative treatment plan that included special diets. Because of the language barrier, she was not certain she understood the nutritional counseling she had received in Mexico. After she returned from Mexico, C. B. made an appointment with Respondent to discuss her nutritional needs. C. B. and Respondent met only on one occasion in late January or early February 1996. Respondent’s nutritional counseling typically includes three visits. The first visit is typically an informal meeting during which he explains nutritional counseling to the prospective client, which includes a discussion as to the client’s nutritional needs and goals. If the client wants to continue with the other two visits, Respondent prepares and thereafter implements a nutritional plan for the client. C. B. decided that she did not want to pursue the other two visits with Respondent. Consequently, Respondent did not prepare a nutritional assessment of C. B., did not prepare a nutritional plan for C. B., and did not become her nutritional counselor. During his meeting with C. B., Respondent discussed her illness and the fact that she was taking Tamoxifen. C. B. testified in her deposition that Respondent told her that Tamoxifen was a killer drug and that she should stop taking the drug. C. B. also testified that she was sure Respondent had told her to stop taking Tamoxifen. Respondent testified, credibly, that he did not tell C. B. to stop taking Tamoxifen, but that he discussed the drug and its severe side effects with her so she could make an informed decision as to her course of treatment. C. B. was in hospice at the time of her deposition and heavily medicated. C. B. readily conceded that the medication she was on impaired her memory. It is not clear whether C. B. accurately recalled the statements made by Respondent, as opposed to recalling her interpretation of what Respondent had said. This conflict in the evidence is resolved by finding that Respondent discussed with C. B. the severe side effects of Tamoxifen in a manner designed to discourage C. B. from taking the medicine. The testimony of C. B. is insufficient to establish by clear and convincing evidence that Respondent told her to stop taking Tamoxifen. Respondent did not hold himself out as a physician or as a pharmacist.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order that adopts the findings of fact and conclusions of law contained herein. It is further recommended that the final order dismiss the administrative complaint against Respondent. DONE AND ENTERED this 5th day of June, 1997, in Tallahassee, Leon County, Florida. Hearings Hearings CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative this 5th day of June, 1997

Florida Laws (3) 120.5720.42468.518
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JESSE BRANCELONE vs BOARD OF MEDICINE, 97-005276F (1997)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Nov. 07, 1997 Number: 97-005276F Latest Update: Apr. 27, 1998

The Issue Whether Petitioner is entitled to an award of attorney's fees and costs under the Florida Equal Access to Justice Act, Section 57.111, Florida Statutes.

Findings Of Fact By letter dated November 9, 1995, Dr. Francisco Belette, an oncologist, filed a complaint with the Department of Professional Regulation pertaining to Mr. Brancaleone's dealings with Christine B., a cancer patient who was being treated by Dr. Belette. That letter describes the unfortunate progression of his patient's breast cancer and includes the following: It was decided to start Christine on Tamoxifen therapy on 10/18/95. This therapy is being given in conjunction with aggressive chemotherapy and ultimately a stem cell transplant. It is my intention to offer Christine a chance at long term survival. Christine returned on 10/24/95 for f/u (a follow up visit). At this time she informed me of her conversations with Mr. Jesse Brancaleone. This gentlemen is a "nutritionist" who works at the Palm Lakes Natural Food Market. According to Christine this "nutritionist" advised her to stop taking the Tamoxifen immediately since he feels "Tamoxifen like other drugs we administer, are poisons." He claims that he "has treated thousands of cancer patients and that what we doctors do to patients is a travesty. We poison them without research." On the contrary, Tamoxifen has more than proven its role in the treatment of breast cancer. I am deeply troubled by what this gentlemen has said to my patient. He has jeopardized my patient/doctor relationship. I feel he is giving false information to patients and therefore practicing medicine without a license. I would appreciate your immediate intervention and investigation into this matter. . . . Thereafter, Daniel A. Pantano investigated the complaint on behalf of the agency and submitted an Investigative Report that was made available to the probable cause panel when it considered this matter. As part of his investigation, Mr. Pantano interviewed Dr. Belette and Christine B. by telephone. The Investigative Report reflected that Dr. Belette's telephone interview confirmed the allegations made in his letter of November 9, 1995. The Investigative Report reflected that the telephone interview of Christine B. confirmed that Mr. Brancaleone told Christine B. that she should stop taking the Tamoxifen medication that had been prescribed by Dr. Belette. By letter dated January 10, 1996, Mr. Pantano advised Mr. Brancaleone of Dr. Belette's allegations and gave him an opportunity to respond. By letter dated January 23, 1996, Mr. Brancaleone wrote the following letter in response to Mr. Pantano's letter of January 10, 1996: Please allow this letter to be my response to a complaint made by a Dr. Belette concerning one of his patients. Christine [B.] came to me for help due to her concerns over the failure of Dr. Belette in treating her breast cancer as her cancer markers continue to increase along with malignant cells over the past three years. She wanted me to build her immune system, nutritional status, and to supply her with information concerning the use of drugs and alternative methods of treatment. It was my intention to give Christine all of the information she desired concerning what nutrition and lifestyle changes have to offer her, the well known and documented side effects of taking drugs, alternative medical doctors and treatments she should consider in order to make an informed and educated decision as to what treatment she deems best for herself. I tell my clients only to be aware of the dangers and side effects of taking drugs as well as other chemicals. I do not give false information as Dr. Belette contends. The toxic reactions and side effects of drugs and other chemicals are stated in the Physicians Desk Reference, reported in prestigeous [sic] medical journals and institutions by research scientists and medical doctors throughout this country and world. This information is available to the general public. As a professional, I have an obligation to my clients to make them aware of any substance that will retard their nutritional status and immunity. I work with many wholestic [sic] medical doctors, knowledgable [sic] in the need to nutritionally support the body. They know the importance nutrition plays in their patients [sic] ability to recover. In my twenty-five years as a practicing nutritionist and six years on the radio helping people recover form illness and educating them as to a healthy lifestyle, I have never hurt anyone or had a complaint such as this. It is unfortunate that Dr. Belette is so ill-informed about orthomolecular [sic] medicine and nutritional biochemistry. Full disclosure, effects of treatments, success and failure rates, the right to a second opinion and alternative treatments are a basic right [sic] of all people. Dr. Belette, in my opinion, has compromised his patient's ability to make an informed choice and his desire to keep her ill- informed is the basis of this complaint. Please feel free to contact me at anytime. At the times pertinent to this proceeding, the North Probable Cause Panel for the Board of Medicine consisted of Dr. George Slade, M.D., Fred Varn, and Dr. Georges El-Bahri. Randy Collette, Esquire, was the attorney representing the Agency for Health Care Administration. Michael A. Mone', Esquire, was acting counsel for the Board of Medicine. The North Probable Cause Panel of the Board of Medicine considered this matter at a meeting on April 24, 1996. At the beginning of the meeting, Mr. Varn, Mr. Mone', and Mr. Collette were physically present at the Northwood Center in Tallahassee, where the meeting took place. Dr. El-Bahir participated in the meeting by telephone. Also present were Jim Cooksey and Bob Gary. Mr. Cooksey identified himself as being with "investigations." Mr. Gary identified himself as "OMC manager for north Florida." At the beginning of the meeting, certain precautionary instructions were given by the attorneys. Dr. Slade arrived at the meeting after the precautionary instructions were given but before the consideration of Mr. Brancaleone's case. Mr. Mone' advised Mr. Varn and Dr. El-Bahir that any questions concerning interpretation of the laws or rules, including the questions as to the duties of the probable cause panel, should be directed to him. Mr. Mone' also advised that Mr. Collette, as the attorney for the agency, had the responsibility of explaining the facts of the case, the reasons the agency was making its recommendation, and of answering any questions concerning the facts, the investigation, and the recommendation. Mr. Mone' further advised that the probable cause panel should not "rubber stamp" the proposed agency action, but that it should have a meaningful discussion of the reasons why probable cause is found. Both Mr. Varn and Dr. El-Bahir acknowledged they had the Investigative Report and the attachments, including the letters discussed above. Dr. Slade arrived after these acknowledgments were made. The transcript of the Probable Cause Panel meeting reflects, in pertinent part, the following: MR. COLLETTE: A-15, Jesse Brancaleone, nutrition counselor 95-17792. In February of 1993 patient CB was diagnosed as suffering from breast cancer by physician [sic], the patient had stage-two invasive duct carcinoma and started on four cycles of admiacin (ph) and two cycles of Cytosan is that it? C-y-t- o-s-a-n. MR. MONE: Cytosan. MR. COLLETTE: Cytosan. Okay. In October of '95, the patient was also started on tamoxifen therapy to be given in conjunction with aggressive chemotherapy. The patient subsequently presented to Respondent for nutritional counseling. Respondent advised the patient to discontinue taking the tamoxifen. Respondent advised the patient that the tamoxifen and other drugs prescribed by patient's physician were poisons. Respondent presented the petitioner with a written statement in January '96 which states that the patient presented to him to obtain information regarding her immune system, nutritional status and to supply her with information regarding the use of drugs and alternative methods for treatment of cancer. Respondent further indicated he advised the patient of the side effects of the medication prescribed by her physician. It's therefore alleged Respondent attempted to implement a dietary plan for a condition for which the patient was under active care of a physician, without the oral or written dietary order of the patient's physician, in violation of the provisions of Section 468.516(1)(a). It's further alleged Respondent inappropriately attempted to treat the patient's condition by means other than by dietetics and nutrition practice. Based on these facts, the Agency is alleging violations of 468.518(1)(a) and (j), recommends probable cause be found and an administrative complaint be filed. Because of the facts of the case the Agency recommends permanent revocation or suspension be sought as the maximum penalty available in the case. DR. SLADE: Motion? DR. EL-BAHRI: Moved. DR. SLADE: Second. This is certainly an egregious violation, it seems to me. MR. MONE': You don't have an (h) violation then, too, do you?1 MR. COLLETTE: No. DR. SLADE: (h) violation? MR. MONE': Is there an (h) violation that you are suggesting in there as well? MR. COLLETTE: I don't think so. MR. MONE': Committing an act of fraud or deceit or negligence or competency or misconduct. MR. COLLETTE: I don't have an opinion that backs me up to go that far. MR. MONE': Okay. MR. COLLETTE: I think that's something that we maybe were looking at at one time, but I didn't have enough to go forward on it. DR. SLADE: It doesn't speak for itself, though? It seems to me. MR. MONE': The problem is that while you and I and most of the medical world may agree that it speaks for itself, in the course of a prosecution, the hearing officer is going on those types of violations to rely on an expert opinion and some expert to come in and say that it is. MR. COLLETTE: I think it's much more evident on its face for the violation of inappropriately attempting to treat patient's means, by means other than dietetic or nutrition practices. I think that's something that anybody can see, you know. Nutrition counselors and dieticians are not in the realm of deciding when or when not to prescribe tamoxifen or other chemotherapy or treatment drugs of that nature; that's strictly the purview of specialized physicians and not nutrition counselors. DR. EL-BAHRI: Dr. Slade. DR. SLADE: Yes. DR. EL-BAHRI: Isn't it clear that he attempted to discontinue or he discontinued the tamoxifen, right? DR. SLADE: Yes. MR. COLLETTE: That's what the patient is alleging and will swear to, is that the nutrition counselor told her to stop taking the tamoxifen. DR. EL-BAHRI: Which is, by itself, is a pretty serious violation. MR. COLLETTE: Yes, it is; but it's the violation of attempting to treat a patient by means other than nutrition counseling. He is basically - DR. EL-BAHRI: Practicing without a license. 2 MR. COLLETTE: He is very, very close to that offense, yes, sir. Very close. DR. SLADE: And we -permanent record-okay, I just wanted to make sure. MR. COLLETTE: Yes. DR. SLADE: Okay. All in favor? (Chorus of ayes.) Based on the stipulation of the parties, it is found that the amount of attorney's fees and costs reflected by the affidavit filed prior to hearing were reasonable and necessary up to the point of October 29, 1997. Based on the stipulation of the parties, it is found that the there are no circumstances which would make an award of fees and costs unjust. Based on the stipulation of the parties, it is found that the DOH and AHCA were not nominal parties in DOAH Case No. 96-3354. Based on the stipulation of the parties, it is found that Mr. Brancaleone was a prevailing party in DOAH Case No. 96-3354. The affidavit filed at the formal hearing in this proceeding, is, in the absence of any evidence to the contrary, found to be for services that were reasonable and necessary. At all times pertinent to this proceeding, Part X of Chapter 468, Florida Statutes, consisting of Sections 468.501 through 458.518, constituted the Florida Dietetics and Nutrition Practice Act. At all times pertinent to this proceeding, Section 468.516(1)(a), Florida Statutes, has provided as follows: (1)(a) A licensee under this part shall not implement a dietary plan for a condition for which the patient is under the active care of a physician licensed under chapter 458 or chapter 459, without the oral or written dietary order of the referring physician. In the event the licensee is unable to obtain authorization or consultation after a good faith effort to obtain it from the physician, the licensee may use professional discretion in providing nutrition services until authorization or consultation is obtained from the physician. At all times pertinent to this proceeding, Section 468.518(1)(a) and (j), Florida Statutes, have provided as follows: The following acts constitute grounds for which the disciplinary actions in subsection (2) may be taken: Violating any provision of this part, any board or agency rule adopted pursuant thereto, or any lawful order of the board or agency previously entered in a disciplinary hearing held pursuant to this part, or failing to comply with a lawfully issued subpoena of the agency. The provisions of this paragraph also apply to any order or subpoena previously issued by the Department of Business and Professional Regulation during its period of regulatory control over this part. * * * (j) Treating or undertaking to treat human ailments by means other than by dietetics and nutrition practice or nutritional counseling. Count One of the Administrative Complaint in DOAH Case No. 96-3354 charged that Mr. Brancaleone attempted to implement a dietary plan for Christine B., thereby violating the provisions of Section 468.516(1)(a), Florida Statutes. The violation of Section 468.516(1)(a), Florida Statutes, was alleged to be a violation of Section 468.518(1)(a), Florida Statutes.3 Count Two of the Administrative Complaint in DOAH Case No. 96-3354 charged that Mr. Brancaleone attempted to treat Christine B.'s condition by means other than by dietetics and nutrition practice.4 Mr. Brancaleone is the owner of a Subchapter S corporation named Palm Lakes Natural Food Market and Café, Incorporated, which operates as a natural food market and café in Margate, Florida. At the times pertinent to this proceeding, Mr. Brancaleone engaged in the practice of nutritional counseling in the back of the natural food market and café. The fees earned by Mr. Brancaleone as a nutritional counselor are paid directly to him, not to his corporation. Although he testified that he was an employee of that corporation and that he practiced from facilities owned by that corporation, Mr. Brancaleone did not establish that he practiced nutritional counseling through his corporate entity. Mr. Brancaleone did not have a net worth of two million dollars or more at any time pertinent to this proceeding. Mr. Brancaleone's corporation did not have a net worth of two million dollars or more at any time pertinent to this proceeding. Mr. Brancaleone did not employ more than twenty-five full time employees at any time pertinent to this proceeding. Mr. Brancaleone's corporation did not employ more than twenty- five full time employees at any time pertinent to this proceeding.

Florida Laws (9) 120.57120.68458.305468.501468.503468.516468.51857.10557.111 Florida Administrative Code (1) 64B8-43.002
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