3
.-_ SPECIAL ARTICLE THE UNPROVEN REMEDIES COMMITTEE MICHAEL The Unproven Remedies Subcommittee of the Arthntis Foundation (AF) Public Education Committee monitors and advises staff on making public response to unusual or unorthodox therapeutic claims. In fast- breaking news items, the Atlanta office responds pub- licly through the office of the Vice President for Public Education, after consultation with the Senior Vice Pres- ident for Medical Affairs, the Chairman of the Sub- committee, members of the Subcommittee, and/or ex- perts chosen on an ad hoc basis. Arthritis Foundation chapters are informed via Public Information Memos within days on new items or problems. American Rheu- matism Association (ARA) members may obtain this immediate information through their AF chapters. This report describes commonly and recently en- countered unproven remedies. Vaccines. An unproven remedy consisting of a vaccine made up of mixed respiratory (bacterial and in- fluenza) vaccines, first proposed for treating both rheu- matoid arthritis (RA) and osteoarthritis (OA) by a Cali- fornia general practitioner, is now used by a few physicians in the United States. An AF investigation of one well publicized clinic demonstrated no data capable of supporting the claims for effectiveness. Hormones. Vuron. A Texas endocrinologist claimed that injected sex hormones ameliorate arthritis. He presented his data to a local rheumatology society. Michael D. Lockshin, MD, Associate Professor of Medicine. Department of Medicine, The Hospital for Special Surgery, New York, New York. Address reprint requests to Michael D. Lockshin. MI), De- partment of Medicine, The Hospital for Special Surgery, 535 East 70th Street, New York, New York 10021. Submitted for publication March 17, 1981; accepted March 19. 1981. D. LOCKSHIN The records and data failed to support the claim, and the consensus of rheumatologists present was that the proponent poorly understood the diseases and the issues in question. He has continued to provide this treatment to patients for several years. Liefcort. Claims for this concoction were first made in the early 1960s, and arthritis patients in the United States were attracted to a clinic in Montreal to purchase supplies for take-home self-dosage. Purported to be effective in the treatment of RA and OA, Liefcort is a combination of prednisone, estradiol, and testoste- rone; the latter two drugs allegedly prevent steroid side- effects. The usual dose is 15 mg per day of prednisone, given as a liquid drop under the tongue. A lawyer spear- heads a group called the “Arthritis Medical Center,” which has opened clinic offices in New York, Florida, and elsewhere, which has successfully delayed legal action with counter suits and injunctions. A second group promotes the same product under the auspices of M.A.R.T.A. (Medical Association for Research and Treatment of Arthritis) in the Southeast. The treatment is generally known as the Liefmann Balanced Hormone Method. At one time, the widow of Dr. Liefmann sold it as Rheumatril from clinics in Santo Doming0 and Mex- ico. It is currently prescribed by a Dr. Soria at his clinic in Rosarito Beach, Mexico. There is no current evidence to justify the claim of benefit from the sex hormones. The Liefcort claim is based on a single sentence in an early paper from the Mayo Clinic. One of the authors of the Mayo Clinic pa- per specifically states that subsequent work refutes the early observation and, thus, the hypothesis on which Liefcort is based. The various clinics offering Liefcort give no data regarding followup or diagnosis. Treatment in certain clinics in Mexico. Dr. Luis Arthritis and Rheumatism, Vol. 24, No. 9 (September 1981)

The unproven remedies committee

Embed Size (px)

Citation preview

Page 1: The unproven remedies committee

.-_ SPECIAL ARTICLE

THE UNPROVEN REMEDIES COMMITTEE MICHAEL

The Unproven Remedies Subcommittee of the Arthntis Foundation (AF) Public Education Committee monitors and advises staff on making public response to unusual or unorthodox therapeutic claims. In fast- breaking news items, the Atlanta office responds pub- licly through the office of the Vice President for Public Education, after consultation with the Senior Vice Pres- ident for Medical Affairs, the Chairman of the Sub- committee, members of the Subcommittee, and/or ex- perts chosen on an ad hoc basis. Arthritis Foundation chapters are informed via Public Information Memos within days on new items or problems. American Rheu- matism Association (ARA) members may obtain this immediate information through their AF chapters.

This report describes commonly and recently en- countered unproven remedies.

Vaccines. An unproven remedy consisting of a vaccine made up of mixed respiratory (bacterial and in- fluenza) vaccines, first proposed for treating both rheu- matoid arthritis (RA) and osteoarthritis (OA) by a Cali- fornia general practitioner, is now used by a few physicians in the United States. An AF investigation of one well publicized clinic demonstrated no data capable of supporting the claims for effectiveness.

Hormones. Vuron. A Texas endocrinologist claimed that injected sex hormones ameliorate arthritis. He presented his data to a local rheumatology society.

Michael D. Lockshin, MD, Associate Professor of Medicine. Department of Medicine, The Hospital for Special Surgery, New York, New York.

Address reprint requests to Michael D. Lockshin. MI), De- partment of Medicine, The Hospital for Special Surgery, 535 East 70th Street, New York, New York 10021.

Submitted for publication March 17, 1981; accepted March 19. 1981.

D. LOCKSHIN

The records and data failed to support the claim, and the consensus of rheumatologists present was that the proponent poorly understood the diseases and the issues in question. He has continued to provide this treatment to patients for several years.

Liefcort. Claims for this concoction were first made in the early 1960s, and arthritis patients in the United States were attracted to a clinic in Montreal to purchase supplies for take-home self-dosage. Purported to be effective in the treatment of RA and OA, Liefcort is a combination of prednisone, estradiol, and testoste- rone; the latter two drugs allegedly prevent steroid side- effects. The usual dose is 15 mg per day of prednisone, given as a liquid drop under the tongue. A lawyer spear- heads a group called the “Arthritis Medical Center,” which has opened clinic offices in New York, Florida, and elsewhere, which has successfully delayed legal action with counter suits and injunctions. A second group promotes the same product under the auspices of M.A.R.T.A. (Medical Association for Research and Treatment of Arthritis) in the Southeast. The treatment is generally known as the Liefmann Balanced Hormone Method. At one time, the widow of Dr. Liefmann sold it as Rheumatril from clinics in Santo Doming0 and Mex- ico. It is currently prescribed by a Dr. Soria at his clinic in Rosarito Beach, Mexico.

There is no current evidence to justify the claim of benefit from the sex hormones. The Liefcort claim is based on a single sentence in an early paper from the Mayo Clinic. One of the authors of the Mayo Clinic pa- per specifically states that subsequent work refutes the early observation and, thus, the hypothesis on which Liefcort is based. The various clinics offering Liefcort give no data regarding followup or diagnosis.

Treatment in certain clinics in Mexico. Dr. Luis

Arthritis and Rheumatism, Vol. 24, No. 9 (September 1981)

Page 2: The unproven remedies committee

UNPROVEN REMEDIES 1189

Camllo in Mexicali treats patients with corticosteroids and tranquilizers. Dr. Ernesto Chavarria, working in Piedras Negras, lures patients with promises of DMSO but actually provides phenylbutazone, tranquilizers, aminopyrine, and dipyrone instead.

Dimethylsulfoxide (DMSO). This agent does not deserve the long and widespread publicity it has ob- tained. It may have some usefulness as an analgesic or balm. Data from Europe and from pharmaceutical houses indicate that it is not a miracle drug for RA or OA, although it may not be as dangerous as once feared. It is widely available as a prescription drug (50% solution) for the indication of interstitial cystitis. Pa- tients and athletes have also been able to obtain a veter- inary DMSO product (900/0); fly-by-night operators have found a ready, high-profit market for industrial grade DMSO, a solvent or degreaser that is nearly 100% pure, which is bought by persons who use it medically. An AF patient information pamphlet on DMSO is in prep- aration.

Venoms. Cobra-Krait. Produced by a snake han- dler, this “remedy” was administered by a now-de- ceased physician in Florida for RA, OA, and multiple sclerosis. As determined through a workshop convened by the Bureau of Biologics, there were no data to sub- stantiate the claims made; the immunologically inter- esting cobra venom factor was not present in the prod- uct; the product was not uniform; and it contained, despite the manufacturer’s prior denial, moccasin ven- om (which, unlike cobra or krait venoms, could have been implicated in a death from cerebral hemorrhage that occurred in a patient taking the venom). The Food and Drug Administration (FDA) has taken an ac- tive interest and has been in litigation against the sup- plier, who has been enjoined from selling the venom outside Florida. The AF has cooperated by identifying complainants and expert witnesses.

Bees and ants. Both have been under legitimate study by reputable scientists, and both have been pro- moted and offered as remedies for arthritis without any valid conclusions from scientific investigation. A popu- lar book stimulated public interest in bee venom, but a scientist’s findings failed to justify clinical trials, and there are no proven clinical data to support claims made for it. Ant venom, which got into the hands of unscru- pulous promoters for a time, is undergoing legitimate scientific study, without any outcome so far that would justify clinical trials.

Cocaine. Claims have been made for a cocaine product slightly altered from the street drug and differ- ent from the topical anesthetic. It has been administered

intranasally. The proponent, a California general prac- titioner, failed, despite prior appointment, to show up when an AF investigating team that he had invited to his clinic arrived; his license has since been suspended. There have been totally inadequate data to support the claims of a cure.

Therapy at the clinic of Dr. Bingham. This Southern California clinic (National Arthritis Medical Center) has at various times espoused vaccines, yucca tablets, nutrition, cocaine, and clotrimazole. Physical therapy and rehabilitative efforts are also offered.

Green-lipped mussel extract. This unproven remedy is currently being popularized in a book by a marine chemist who consults on the harvesting of this rare New Zealand mollusk. An extract is obtained by a secret method. The claim is supported by a (poor) thera- peutic trial published in Practitioner, September 1980, and by a study in New Zealand Journal of Medicine, September 1980. In the latter, carrageenan arthritis in mice was ameliorated by intraperitoneal but not oral ex- tract. In the patient study, all patients continued on their antirheumatic drugs.

Chuifong toukuwan. This alleged Chinese herbal remedy contains large amounts of various anti- inflammatory drugs, varying from sample to sample, and not shown on the label.

Gerovital H3. Procaine, promoted by Dr. Ana Aslan, a Roumanian, is claimed to be a fountain of youth and an antirheumatic. No data to justify the claims are offered. Not approved by the FDA, it has been made legal in Nevada.

Antibiotics. A prominent rheumatologist in the Mid-Atlantic area believes that he has proved that mycoplasma cause arthritis and therefore treats RA with tetracycline (together with standard therapy). A prior controlled study (Skinner, Arthritis and Rheuma- tism 14:727, 1971) denies this claim. He has chosen to promote his theories through national media and his in- stitute rather than in refereed journals and has ex- panded his claims to include gorillas and elephants with arthritis.

Diets and nutrition. The AF has prepared a 6- page summary of current knowledge from studies in the past 50 years, abstracted from an extensive review by Dr. William D. Robinson (Chapter 22 in Kelly WN, Hams ED, Ruddy S, Sledge CS: Textbook of Rheuma- tology, W. B. Saunders Co., Philadelphia, 1980). A sum- mary of the popular lay diets and diet books, including elimination diets, is in preparation, and several diet-ar- thritis studies in progress are known to the Committee. When the studies are completed, the Committee will

Page 3: The unproven remedies committee

1190 LOCKSHIN

help disseminate the results. The review documents and supports the Foundation’s position that nutritional fac- tors do not play significant positive or remedial roles in most major forms of arthritis.

This list is certainly not exhaustive but includes some of the more commonly encountered problems fac- ing the Committee at this time. It is important to re- member that “inadequate data” does not mean “worth- less,” and that the Committee name (Unproven Remedies Committee) was carefully chosen. For further details and for immediate information on new items,

ARA members are referred to their local AF chapters and/or to members of the Committee: Michael Lock- shin (New York), Chairman; Wilbur Blechman (North Miami Beach), Vice-chairman; Charles Bennett, At- lanta (AF Consultant); Warren Benson (Tucson); Mary Brassell (Philadelphia); John Decker (Bethesda); David Kaplan (Brooklyn); Sandra Lewis (San Francisco); Robin May (New York); Kinnaird McQuade (Cincin- nati); David Silver (New York); Annette Swezy (Santa Monica); Peter Utsinger (Philadelphia); Cody Wasner (Eugene, Oregon).