Healthy Skepticism Library item: 862
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Mansfield P.
Phenylbutazone.
Med J Aust 1985 Sep 2; 143:(5):219-20
Full text:
To the Editor: Australian doctors may have been puzzled by CIBA-GEIGY’s press release of April 1, 1985, about restricting indications for phenylbutazone (PBZ), because it in fact expanded the suggested indications by adding osteoarthritis to those listed in CIBA-GEIGY’s letter of August 27, 1984. PBZ is a good example of the processes whereby an effective but dangerous old drug is susperseded by safer alternatives. These processes include debate within the profession and reactions by government and industry. (See, for example, the letter to the Journal by E. Auerbach [August 18, 1984] about PBZ losing its government subsidy. The reply by Peter Brooks in the same issue noted that, of the 188 deaths from aplastic anaemia associated with PBZ in the UK between 1964 and 1976, most were “taking the drug for inappropriate indications such as osteoarthritis”. CIBA-GEIGY’s first letter came nine days later).
The process of improvement occur more slowly in the Third World. For example, CIBA-GEIGY’s 1984 packet inserts in Malaysia recommend PBZ for “pain and stiffness in muscles and joints, lumbago, tension headache, virus infections, fever and long term treatment”. 1 This and other fascinating marketing practices have led to expressions of concern by many organizations, including the Medical Lobby for Appropriate Marketing (MLAM). MLAM is a non-profit organization based in Adelaide, with members in 22 countries. We produce a monthly letter, summarizing a current problem with a drug or pesticide and making positive suggestions for safer marketing. All letters are checked by an editorial board. The Australian editors are Prof. Felix Bochner (pharmacology), Dr Julian Gold (epidemiology), Dr Ian Gust (virology), Dr Ken Harvey (microbiology), Dr Basil Hetzel (nutrition), Prof. Garry Kneebone (paediatrics), Prof. Ian Lewis (paediatrics), Prof. Peter McDonald (microbiology), and Prof. John Shaw (pharmacology). MLAM wrote to CIBA-GEIGY about PBZ in Feburary 1985: we congratulate them on their international standardization of indications for PBZ, but wonder if the inclusion of acute ostearthritis is justified.
Journal readers may also be interested in the marketing of pizotifen (a serotonin antagonist) by Sandoz. In Australia, pizotifen is advertised for “recurrent headaches”. 2 The MIMS entry fails to mention its adverse effect of increased appetite and weight gain. In Indonesia, pizotifen is promoted as “the specific appetite stimulate plus vitamins. Effective, practical and safe for all ages”. 3 Unfortunately, serotonin antagonists inhibit the release of growth hormone. MLAM welcomes enquires.
Peter Mansfield, MB BS
MLAM Secretary
Renaissance Arcade, Adelaide, SA 5000
1. Anonymous. Firms accused of double standards. New Straits Times. June 5, 1985.
2. Sandoz Ad, in Craig S. MIMS IMS Publishing 1985; 22: 39
3. Sandoz Ad, in Ng CT. IIMS IMS Pacific 1985; 14: 206-208
The Medical Director of CIBA-GEIGY replies:
We cannot regard our recent revised recommendations for the use of Butazolidin (phenylbutazone, Geigy) as an extension of our previous recommendations. Our new recommendations state quite clearly that Butazolidin is to be regarded only as a drug of second choice, in cases where other therapeutic measures have failed. This is an important further restriction over and above the revised recommendations published in August 1984.
We have consulted our colleagues in Malaysia, through our parent company, regarding Dr Mansfield’s assertion that our package inserts in Malaysia, as recently as 1984, included “pain and stiffness in muscles and joints, lumbago, tension headache, virus infections, fever and long term treatment” as indications for the use of Butazolidin. Supplies for Malaysia are manufactured at our plant in Stein, Switzerland. The package inserts of products sold by CIBA-GEIGY Malaysia are therefore always up to date, and conform to the latest revisions. Inserts in line with headquarters revisions effective from January 1984 have been in use in Malaysia since February 1984. In the case of Butazolidin, the indications listed in this insert were as follows.
Short term treatment (1 week)
Attacks of gout and pseudo-gout.
The following conditions, in cases where the patient has not responded adequately to other non-steroidal anti-inflammatory drugs:
Acute exacerbations of rheumatoid arthritis and osteoarthritis
Acute forms of soft-tissue rheumatism.
Treatment of longer duration
Exacerbations of ankylosing spondylitis, if the patient has not responded adequately to other non-steroidal anti-inflammatory drugs.
Prior to February 1984 another insert was in use, which listed the following indications for the use of Butazolidin.
Adults
Inflammatory rheumatic affections: acute exacerbations of rheumatoid arthritis and ankylosing spondylitis, rheumatic fever.
Degenerative rheumatic diseases: acute exacerbations in cases of osteoarhrosis, spondylitis, spondylarthritis and chondritis/osteochondritis (intervertebral disc syndrome). Soft tissue rheumatism (fibrositis syndrome): acute forms of tendomyopathy, tendinitis, tendovaginitis, bursitis, scapulohumeral and coxal periarthritis, and humeral epicondylitis. Non-rheumatic indications: acute attacks of gout.
Children (aged 6 or older)
Acute exacerbations of juvenile rheumatoid arthritis (Still’s disease), rheumatic fever.
There is therefore no basis for Dr Mansfield’s assertion, which we note is derived from an article published in the New Straits Times, and which appears on this occasion not to have been a sufficiently reliable source.
GL Smith, DTM&H
Medical Director Pharmaceutical Divison
CIBA-GEIGY Australia Ltd, Lane Cove, NSW 2066
