ver, implementation of these regulations has given by the youthful graphic designer in the been lax and patients may well have suffered Legislation, as it applies to the advertising existence there have been only four prosecu- of medicines to doctors, is contained in the tions for breaches of the Medicines Act as it relates to advertising. All have been brought (Advertising to Medical and Dental Practi- instance the plaintiff was an individual work- provisions of this legislation include that product sold on a small scale. Despite the that claims made should reflect available numerous breaches, and despite the statu- The regulations clearly indicate what gov- adherence to the Act, it would appear that ernment requires of the pharmaceutical in- dustry and yet breaches of them are common prepared nor willing to confront the larger place. In a study reported to the British Pharmacological Society in 1984 by a mem- ber of the Department of Health, over half of leave the control of advertising to the indus- the full page advertisements published in the try's own code of practice committee, and previous year had breached the regulations has abrogated its responsibility to such an rejected over half the complaints referred to and consist, for example, of a failure to give a proprietary name. These the industry dismis- ses as 'legal technicalities' and of no signifi- cance. Others see minor breaches as a symp- selected by the industry, is run for and on tom of a widespread and sinister disregard behalf of the industry, uses a code indepen- dent of the law, has no enforceable sanc- tions, has no legal status and has no public advertisement appear, such as that for the accountability. Indeed many assume that the False Claims
cardiac drug amiodarone, which claimed primary role of the committee is to shield the that the drug was essentially devoid of side industry from the public scrutiny of the law Safety of Medicines and articles in the British dominates the prescribing habits of doctors Furthermore, until recently the committee Medical Journal and Lancet were all advising and so essentially determines the medicines that the drug's side effects were such that it that patients receive. The main target for should be given only with special care and probably best by a specialist? How could an who each month receives kilos of unsolicited attention by outside agencies. It therefore advertisement for the antibiotic keflex be had no capacity to prevent misleading adver- published which falsely implied that the drug fronted by pages of advertising in medical tisements appearing in the first instance.
journals. An obvious aim of such promotion Accordingly, in general, by the time it has is to persuade the doctor to prescribe the In most instances, but not all, some indica- deliberated (which takes several months) the tion of the misleading nature of such claims company's campaign will have achieved its can be obtained by scrutinising the warnings, ends, and possibly patients will have suf- of the market (this year the NHS will spend precautions and side effects printed at the fered. Furthermore, breaches of the law will about £1.5 billion on prescribed medicines), bottom of the advertisement. Unfortunately escape prosecution, doctors are unlikely to promotion also strives to increase the size of however, the printing of such information is learn of the nature of the false claim, and patients will certainly have no chance of in which there is a greater reliance of society unquestioned. In a study of the advertise- on medicines for normal life (half of the ment for xanax, six out of 18 doctors were It is difficult to see how ministers can justify healthy adults in the UK take some sort of unable to read the small print unaided, and either their continued abrogation of respon- sibility to a body that has manifestly failed to would not have persevered in other circumst- adequately control advertising. Where leg- £ 180m each year, an amount only just short ances, only continuing as they did for the islation exists perhaps the situation will be of its annual expenditure on research. Pre- sake of the investigation. There is no legal improved once the Department successfully sumably in an attempt to counter possible definition of 'legibility' and one assumes that abuse by the industry with consequent dan- in a court of law it would be dependent upon its senior member(s) for publishing a mislead- gers to patients, legislation was introduced whether it could be read by the judge. His to control advertising. Unfortunately how- findings might be rather different from that



The new england journal of medicineWithdrawal of Long-Term Cabergoline Therapy Annamaria Colao, M.D., Ph.D., Antonella Di Sarno, M.D., Ph.D., Paolo Cappabianca, M.D., Carolina Di Somma, M.D., Ph.D., Rosario Pivonello, M.D., Ph.D., and Gaetano Lombardi, M.D., Ph.D. b a c k g r o u n d Whether the withdrawal of treatment in patients with nontumoral hyperprolactinemia, From the Department

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