Disciplinary Action against Felix Ravikovich, M.D.
Stephen Barrett, M.D.
In 1995, the College of Physicians and Surgeons of Ontario (Canada) concluded that Felix Ravikovich, M.D. had failed to maintain the standrds of practice by inappropriately treating allergy patients with hiistamine. As noted below, the College's discipline commitee reprimanded Ravikovich and ordered him to refrain from using histamine as a diagnostic or therapeutic tool when there is no scientific or medical validity to its use. Ravokovich appealed to the courts, but lost his final appeal in 2007. I read on a proponent Web site that he resumed practice. However, the College's Web site indicates that in November 2010, as a result of investigations and disciplinary proceedings regarding his care and conduct, he agreed to stop practicing medicine not to re-apply for a certificate of registration.
THE COLLEGE OF
PHYSICIANS AND SURGEONS OF ONTARIO
Appeal Status: Appeal Dismissed
Appeal Decision Date: 17 Nov 1997
Hearing Date: 07 Feb 1994
Decision Date: 04 Apr 1995
Publication Date: January/February 1996
Dr. Ravikovich faced charges of professional misconduct for failing to maintain the standard of practice of the profession for practising medicine by employing diagnostic and therapeutic practices which had no scientific or medical validity.
He was also charged with incompetence for allegedly displaying a lack of knowledge, skill or judgement or disregard for the welfare of his patients of a nature or to an extent that demonstrated that he is unfit to continue in practice. Specifically, it was alleged that he employed histamine injections or a histamine prick test for the purpose of diagnosis; that when he employed histamine injections or a histamine prick test for the purpose of diagnosis he did not employ a negative control; that when he employed histamine injections or a histamine prick test for purpose of diagnosis, no objective measurement of any change in the patient was employed in order to assess the results of the injections or histamine prick test; that he employed histamine injections for therapeutic purposes in regard to a variety of conditions when the efficacy of this treatment is unproven; that prior to employing histamine injections on some patients who suffered from asthma he reduced or withdrew their regular medications; that he treated some patients who suffered from food sensitivity with histamine injections or allergens and then allowed the patients to eat suspected food in an unsupervised situation; and that he treated some patients who had no skin tests by administering allergy injections.
It was further alleged that Dr. Ravikovich was guilty of professional misconduct for making misrepresentations respecting a remedy, treatment or device. Specifically, it was alleged that he misrepresented to his patients that histamine injections could be used for the purpose of diagnosis; and that he misrepresented to his patients that histamine injections could be used for therapeutic purposes in regard to a variety of conditions when the efficacy of this treatment is unproven.
Dr. Ravikovich pleaded not guilty to the allegations.
College Expert Testimony
The prosecution called Dr. A, who is the head of clinical immunology at a major hospital and a university associate professor, as an expert witness and the College s only witness.
Dr. A testified that he had reviewed two papers prepared by Dr. Ravikovich concerning his use of histamine as well as the charts of 15 of Dr. Ravikovich s patients shown in the exhibits. When asked by counsel if the use of histamine in the manner described by Dr. Ravikovich was acceptable Dr. A replied certainly not .
Dr. A asserted that the use of histamine for the diagnosis and treatment of allergic conditions as demonstrated in the 15 charts was not acceptable.
Dr. A stated that he did not believe there was any proof that histamine administration had a therapeutic value. Further, in the histamine prick test, the dose was not very important as very little histamine was absorbed. He asserted that it could be dangerous to discontinue a patient s medications, for example, if the patient had severe asthma, before administering histamine therapy.
Expert Witness for the Defence
Defence counsel called Dr. B as an expert witness. Dr. B is licensed and practices in Nova Scotia and Texas. He obtained Certification in Family Medicine (CCFP) from the College of Family Physicians of Canada in 1979 and is a member of two Boards and one Academy of Environmental Medicine.
Dr. B was tendered as an expert in the diagnosis and treatment of allergy especially related to environmental and occupational causes as well as in the use of histamine in the treatment of allergic disorders. His qualifications as an expert witness in the use of histamine in the treatment of allergies were accepted by the Committee. However, the Committee found that he was not qualified to discuss the standards of practice in Ontario.
Dr. B began using histamine as a therapy in 1987 and has used it for diagnosis and therapy in about 1,500 patients both in Nova Scotia and in Dallas, Texas. In Dallas, he estimated, some 25,000 patients have been treated with histamine. Among the allergic problems he has seen, he listed hay fever, asthma, urticaria, eczema, irritable bowel, chemical sensitivity, chronic fatigue syndrome and industrial chemical sensitivities. He also sees patients with encephalopathy which he prefers to call toxic brain syndrome .
Testimony of Dr. Ravikovich
Dr. Ravikovich obtained his licence to practice in 1985. He joined a group practice for some two to three months as a general practitioner but also worked in geriatrics and caring for terminal cases. He opened his solo practice in January 1986, doing general practice at first and then limiting his practice entirely to allergy including asthma.
Dr. Ravikovich referred to his abstract that was published in Allergologie in September 1989 under the title Histamine Therapy In Allergy . Dr. Ravikovich stated that his attempts to publish in Canadian journals have been rejected.
Dr. Ravikovich denied that he, at any time, instructed a patient to stop his or her previous medication. He estimated that 80 to 90 percent of the patients who came to him had stopped using their medications before seeing him. The balance, 10 to 20 percent, were still taking their medicines, even though they were not working very well, because they were afraid to discontinue them.
Dr. Ravikovich s views were summarized as follows: a double-blind study is not necessarily the standard for an old drug that has been in use for a long time even if it is given a new use so long as the patient s disorder has been fully considered by the physician; that the patient has been fully informed of this new use by the doctor; and that the doctor has been able to find some support for his new treatment in the medical literature.
Dr. Ravikovich said that he knew that histamine prick or intradermal tests are used throughout the world by allergists and that histamine is absorbed into the blood in these tests, unlike Dr. A s claims; that large doses of histamine used in the prick test are unacceptable because they may cause shock and that low doses at the start are invariably safe; and that histamine is a component of the allergen skin extracts used by all allergists.
Dr. Ravikovich estimated that 70 to 80 percent of his patients receive histamine desensitization. They range from babies to any adult age perhaps up to 70 years. He feels that the younger patients do better because their immune systems are more resilient. He stated that in 1990 he treated some 2,500 patients with immunomodulation and believes it is about the same each year thereafter. The number of histamine injections that patients would receive is very individual and unpredictable.
When prosecuting counsel pointed out that Dr. Ravikovich had tried to interest Canadian doctors (30 or 40 of them) to do double-blind studies with histamine, Dr. Ravikovich stated that no one in Canada accepted his ideas or procedures and he therefore failed to interest them in doing such a study.
Prosecuting counsel asked Dr. Ravikovich whether it was true that Canadian schools had turned down his proposal to do a double-blind study on the use of histamine, to which the doctor replied yes, but they are ignorant . Dr. Ravikovich also agreed that he could not get his study done abroad.
Prosecuting counsel emphasized that, in fact, no country was prepared to do such a study, and Dr. Ravikovich replied that he had been too busy with his College problems to pursue this matter any further.
The prosecution questioned the scientific basis for Dr. Ravikovich s histamine treatment, pointing out that among the favourite authors that Dr. Ravikovich quotes are Drs. Kaplan and Lichtenstein. In a letter to Dr. A, Dr. Kaplan took the position that nothing in his textbook supported Dr. Ravikovich s histamine therapy. Further, Dr. Lichtenstein in a letter to Dr. A, stated that he had never written about or defended histamine desensitization. Further, he stated, I believe it has no role in any medical therapy.
Finally, prosecution counsel referred to Dr. Ravikovich s article published in New Americans Collected Scientific Reports, Volume 1, 1989. In reply to a question, Dr. Ravikovich conceded that this journal was probably not peer-reviewed. The prosecutor pointed out that following the references at the end of Dr. Ravikovich s paper and under a new heading From the review: , there is a quotation from a November 2, 1989 letter to Dr. Ravikovich from Dr. Holgate, an eminent authority in the field of immunology, as follows: If the results are positive then this would be quite an outstanding contribution to the field of allergy. It was suggested that, when this quotation was brought to Dr. Holgate s attention sometime in September 1992, Dr. Holgate was apparently very upset at the use of his name in this way because he had not in fact reviewed Dr. Ravikovich s article and it was therefore a misrepresentation to use his name at the foot of the article.
Decision: Guilty of Professional Misconduct
In arriving at its decision, the Committee first determined what had been established in evidence as the standard of practice of the profession in Ontario with regard to the diagnosis and treatment of allergic conditions and asthma. The Committee then made factual findings as to what had been proved in evidence that Dr. Ravikovich did and did not do to determine if he fell below the standard proved. The Committee decided that professional misconduct had been established for the following reasons:
- Diagnosis Standard: The Committee considered Dr. A to be a reliable and trustworthy witness. It accepted his evidence that the standard of practice of the profession in Ontario between the years 1985 and 1991, to properly diagnose allergies, required the physician to conduct tests on the patients skin with a positive and negative control before testing with allergens.
- The Treatment Standard: The Committee accepted Dr. A s evidence regarding the 1985-1991 standard of practice in the treatment of allergies. He testified that drug therapy is ultimately the most effective way to treat patients with allergies.
In the treatment of asthma and of psychological disorders, Dr. A testified that if the patient s condition is severe, the patient should be put on medication. It is not acceptable patient management to use histamine injections to treat allergies and, he said, there is no beneficial pharmacological effect in the use of histamine.
- Findings of Fact: Concerning diagnosis - Dr. Ravikovich did employ histamine injections or a histamine prick test to diagnose allergies and asthma but he did not employ a negative control. Dr. Ravikovich claimed that he did employ negative controls when he treated the patient with allergens. However, there is no record of such controls in the examined patient records. When Dr. Ravikovich employed histamine injections or a histamine prick test for purposes of diagnosis, no objective measurement of any change in the patient was employed in order to assess the results of the injections or histamine prick test.
Concerning Treatment Dr. Ravikovich employed histamine injections for therapeutic purposes for a variety of conditions when the efficacy of this treatment is unproven. Dr. Ravikovich presented a double blind study published by Dr. Girard and his colleagues in 1989. However, Dr. Ravikovich was not aware of this study before 1991. Furthermore, Dr. Girard did not employ histamine but rather Histaglobin , a combination of histamine and gammaglobulin. As well, Dr. Girard studied patients who had only very minor asthma.
Dr. Ravikovich treated some patients who had no skin tests by administering allergy injections. Although the Committee accepted the truth of this particular, it does acknowledge that Dr. Ravikovich sometimes selected his allergens on the basis of the substances to which the patients claimed they were allergic.
With regard to the allegation that Dr. Ravikovich misrepresented to his patients that histamine injections could be used for the purposes of diagnosis, the Committee found that he did tell his patients this, and that since histamine injections could not be used for the purpose of diagnosis, this statement was indeed a misrepresentation. Concerning the allegation that histamine injections could be used for therapeutic purposes for a variety of conditions, the Committee found that Dr. Ravikovich did represent this to his patients, and since the efficacy of this treatment is unproven, such statements amounted to a misrepresentation.
Not Guilty of Incompetence
The Committee believes that Dr. Ravikovich showed a lack of judgement in his use of histamine for therapeutic purposes. The Committee wishes to affirm that there are certain obligations which a physician must accept if he or she employs a drug for a new or non-traditional treatment. The drug must be proven safe. The physician must record in considerable detail the clinical state of the patient and the changes in this state, both good and bad, that are produced by the medication. The physician should be aware of all of the pertinent publications that bear on the clinical problem as well as on the proposed treatment.
It is the opinion of the Committee that Dr. Ravikovich s employment of histamine therapy did not fulfill all these criteria. Although his judgement in the circumstances was inadequate, it was not established that the lack of judgement was of such a nature or extent so as to demonstrate that Dr. Ravikovich is unfit to continue in practice.
The Committee wishes to reiterate in imposing penalty, that it accepts the principle, now encoded in Ontario Regulation 52/95 made under the Medicine Act, 1991, which states the fact that a member uses or recommends a non-traditional treatment is not, by itself, determinative of deficient clinical ability . The penalty imposed follows from the findings of the Committee as set out in the decision and reasons for decision.
The Committee makes the following Order as to Penalty:
- Dr. Ravikovich is to be reprimanded and the fact of the reprimand is to be recorded on the Register;
- A restriction on Dr. Ravikovich s certificate of registration is to be imposed for an indefinite period, prohibiting Dr. Ravikovich from employing histamine for purposes of diagnosis or therapy in the practice of medicine except for the employment of histamine as a positive control in standard allergy skin testing. Furthermore, such prohibition is not to apply to the employment by Dr. Ravikovich of standard allergen extracts in accordance with the accepted standard of practice of the College. Apart from the two exceptions listed above, Dr. Ravikovich is not to employ for diagnostic or therapeutic purposes, any biological material which contains histamine;
- Dr. Ravikovich s certificate of registration is to be suspended for three months, the suspension to be suspended on condition that Dr. Ravikovich submits his practice to inspection by an inspector appointed by the Registrar, including the production of the records of his practice, within six months of this Order becoming final.
Dr. Ravikovich has shown himself to be lacking in awareness of the potential for harm to patients in employing histamine as he did when he said, in his statement to the Committee, at the penalty hearing, my errors remain unknown to me. The Committee believes that the public is protected by the Order it made, in that it prohibits Dr. Ravikovich, as a condition of his certificate of registration, from using histamine as a diagnostic or therapeutic tool when there is no scientific or medical validity to its use.
This page wasposted on July 19, 2012.