MONITORING DRUG ADVERTISEMENTS

980 MONITORING DRUG ADVERTISEMENTS

SIR,-Dr Collier and Dr Herxheimer’s report (Jan 10, p 113) and subsequent correspondence highlight the need for a means to control advertising and promotional practices. For some time the Canadian Pharmaceutical Advertising Advisory Board (PAAB) has been following reports on the control of pharmaceutical promotional practices. In particular we have noted the establishment of a World Health Organisation committee with a mandate to prepare guidelines and develop an international marketing code. For ten years the PAAB, in collaboration with the Canadian pharmaceutical industry, has been operating a clearance programme for pharmaceutical advertising. We are an autonomous, multidisciplinary body established in 1976 as a result of concerns expressed by Federal and Provincial Health Departments about the advertising and promotional practices of some pharmaceutical companies in Canada. These concerns were similar to those presented by Collier and Herxheimer and now under discussion by 1B WHO. We require advertisements to comply with strict ethical standards incorporated in the PAAB Code of Advertising Acceptance. The objective is to ensure the accuracy of pharmaceutical information to health professions, in the ultimate best interest of patients-and the PAAB has a major role in the dissemination of accurate and useful pharmaceutical information in Canada. The self-regulatory approach has proved effective. Our approach may serve as a useful blueprint for guidelines from organisations such as WHO, the UK Medicines Commission, or the International Federation of Pharmaceutical Manufacturers Associations, either by self-regulation or with government supervision. Although it is independent, the PAAB liaises with the Health Protection Branch of Health and Welfare Canada. The branch is a non-voting member of the board and acts as adviser to us.

The PAAB office has an administrative staff of only four people-a commissioner (a pharmacist with experience in the drug industry), an assistant commissioner, and two secretaries/clerks. The board itself is comprised of eight voting delegates representing the medical and pharmacy professions, consumers, the pharmaceutical industry, the health media, and the Canadian Advertising Foundation. Non-voting observers from the Pharmaceutical Marketing Clubs of Ontario and Quebec and the Association of Medical Advertising Agencies also attend board meetings. Operating expenses are met entirely through advertisement review fees. The range is from$100 to$325, the latter covering a full journal advertisement. During 1986 1337 submissions were reviewed. About 90 % required some amendment before approval. However, only 10% needed extensive discussion and negotiation, which are essential and integral parts of the review process. The two industry associations represented on our board cover about 95% of the major pharmaceutical companies in Canada. Participation in the programme is very strong and only rarely does a journal advertisement appear without our imprimatur. Pharmaceutical Advertising Advisory Board,

Pickering,

JOHN O. GODDEN,

Ontario L1V 1A1, Canada

Chairman

CLINICAL PHARMACOLOGY AND GERIATRICS of the risk/benefit ratio of drugs in elderly SiR,—The patients is often difficult. Tognoni and Bonatil and Dr Carbonin and colleagues (March 28, p 747) suggest that the methods of clinical pharmacology be applied to elderly subjects before a drug is marketed. This was also proposed at a meeting on normal ageing and clinical problems (Montreux, Switzerland, March 30 to April 2, 1987). The proposed aims are to detect adverse drug reactions and to assess efficacy, taking into account associated diseases and multiple drug regimens, before a drug is marketed for elderly patients. Besides the difficulty of defining old age (chronological or physiological?), the proposition of studying prospectively all possible multiple disease/multiple drug interactions in phase II or III is not feasible, if only because of the number of patients to be studied. assessment

Assessing the incidence of side-effects from premarketing studies is possible if the side-effect is frequent (a few percent of the patients treated), but to evaluate the incidence of rarer events, the number of patients that has to be studied increases by thousands. This number is hard to obtain in homogeneous young patients, and becomes impossible to obtain in elderly patients, especially if one wants to stratify by associated diseases and/or drugs.. Pharmacokinetic studies should be done for baseline values in normal elderly volunteers and perhaps in patients with single diseases, as well as phase II dose-ranging studies. These studies should not retard the marketing of the drug. Once the drug is marketed, systems exist to monitor side-effects, such as the Committee on Safety of Medicines in the UK, or the national pharmacovigilance system in France. From the reports they receive, problem areas can be defmed and studied, either prospectively with phase II and III methods, or with epidemiological methods. Prescription-event monitoring can also be used. The limitation of the system is under-reporting. Physicians must be reminded that side-effects in elderly patients are frequent, often atypical, misleading, or attributed to old age (eg, depression, parkinsonism, chronic organ failure). Reporting any untoward or unusual event in elderly patients taking new drugs is an act of public health. Using existing structures, which are usually staffed by clinical pharmacologists and epidemiologists trained in adverse drug reaction monitoring and evaluation, is more cost-effective than creating new systems. Hôpital de Boisguillaume, 76230 Boisguillaume, France 1.

Tognoni G,

Bonan M.

NICHOLAS D. MOORE

Second-generation

clinical

pharmacology.

Lancet 1986;

ii.

1028-29.

MEDICAL CARE FOR THE HOMELESS

SIR,-We were fascinated by the investigation of psychiatric illness among guests at the 1986 Crisis at Christmas Open by Mr Weller and colleagues (March 7, p 553). We have worked in the surgery (clinic) at this facility and recorded details of 45 consecutive attenders on one day. By contrast with Weller’s case-fmding approach our series were self-referrals. The group was predominantly male with a mean age of 41 years (range 19-61). Consultation was sought for a variety of acute and chronic, physical and psychiatric problems: Acute problem

24 10 9 4 1

Respiratory disease Minor trauma Acute diarrhoea Thrombosed piles

Chronic disease Chronic skin condition Drug request

Lymphadenopathy Chronic pancreatitis Diabetes

Alcohol/drug abuse

12 7 2 2 1

Drug request Syringe request Alcohol withdrawal Overdose

Amputation problem Psychiatric disease ? Munchausen’s syndrome Chronic schizophrenia Panic attack

14 6 3 2 1 1 1 4 2 1 1

Most problems were acute though acute respiratory tract infections, for example, were commonly on a background of chronic chest disease. Minor trauma, including 1 case of cold injury, was

There was a suspicion that the 2 men seeking treatment diarrhoea abused opioid medication but this was unproven. The most common chronic physical complaints were skin conditions, including leg ulcers and infestation. 1 man had stump problems following an amputation but had apparently alienated himself from the limb-fitting services. 3 men needed supplies of maintenance medication as they had been unable to obtain prescriptions (phenytoin 2, digoxin/diuretics . 1, anticommon.

for

acute

cholinergic 1). Whilst

we

were

aware

that

some

attenders had chronic

psychiatric disease, time constraints forced us to concentrate on the presenting problem, and detailed psychiatric screening was not undertaken. It is likely that the withdrawn did not attend. However, 16 patients presented with drug/alcohol abuse or overt psychiatric disease, including 2 suspected of Munchausen’s syndrome. Of the