MaLAMBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7022.61a (Published 06 January 1996) Cite this as: BMJ 1996;312:61
- Trisha Greenhalgh
I once held an obstetrics post at a hospital known for the uncompromising attitude of its midwives. When a new mother expressed anxieties about breast feeding, one of them could be relied on to appear at the next feed with a bottle of formula milk and, if a junior doctor could be persuaded to sanction the act, the first instalment of a 10 day course of bromocriptine—the safety, efficacy, and indispensability of which had apparently been confirmed by a smoothtalking pharmaceutical representative.
A retired community midwife friend, on hearing of this tradition, snorted with derision and said, “cabbages.” White ones, with stiff leaves, broken and packed into the brassiere, were all that was needed, and then only when the mother could not be coaxed to resume her efforts to breast feed. In 1994, this view was acknowledged by the US Food and Drug Administration (FDA), which filed a lawsuit against Sandoz, the manufacturers of the leading brand of bromocriptine (Parlodel), challenging its licence for the suppression of physiological lactation. An American consumer pressure group claimed that FDA data showed a total of 531 adverse drug reactions to bromocriptine between 1980 and 1994, including 32 deaths, 36 strokes, 14 heart attacks, and 98 cases of seizures.
Sandoz voluntarily withdrew physiological lactation as an indication for Parlodel in the United States and Canada within days of the launch of the FDA lawsuit. The British data sheet has now been modified to read “inhibition or suppression of puerperal lactation for medical reasons” (my italics). However, a correspondent to the Medical Lobby for Appropriate Marketing (MaLAM) was issued by a Sandoz representative in Pakistan with a data sheet claiming that the drug is “safe … and significantly effective in the prevention or suppression of established lactation.”
In January 1995, in a mailshot initiated by MaLAM, several hundred doctors worldwide wrote to the international chairman of Sandoz asking what circumstances had justified the company's apparent double standard in this case. His 10 page reply to MaLAM head office cited countless research trials but conspicuously failed to defend the policy of one data sheet for developed countries and another for the Third World. Perhaps, speculated a MaLAM editorial in response, the quality of information provided in each country was proportional to the degree of pressure exerted on the company by the government, the medical profession, or consumers. In July, after continued pressure on the company, the chairman of Sandoz admitted in writing that “we acknowledge the mistakes made in Pakistan and regret them.” Later arrangements were made for three senior directors of Sandoz to travel to Australia to meet MaLAM's president and talk through issues of scientific fact, interpretation of evidence, and the company's accountability for the behaviour of its international subsidiaries.
Most of us can recall examples of drug marketing—advertisements, claims by company representatives, or the provision of inappropriate “starter packs”—which have made us resolve to send off a letter of complaint. Lack of time, lack of conviction, or the perceived futility of hurling our tiny pebble at some great pharmaceutical Goliath, deadens our fervour in nine cases out of 10. Yet professionally led protests about the marketing of drugs are usually justified and often effective, especially when they are planned, co-ordinated, and systematically followed through. Membership of MaLAM-UK costs pounds sterling20 per year (waged) or pounds sterling6 (unwaged); details are available from John Appleby, 13 Springhead Road, Thornton, Bradford BD13 3DA.—TRISHA GREENHALGH, general practitioner, London