980

MONITORING DRUG ADVERTISEMENTS

SIR,-Dr Collier and Dr Herxheimer’s report (Jan 10, p 113) andsubsequent correspondence highlight the need for a means tocontrol advertising and promotional practices. For some time theCanadian Pharmaceutical Advertising Advisory Board (PAAB) hasbeen following reports on the control of pharmaceuticalpromotional practices. In particular we have noted theestablishment of a World Health Organisation committee with amandate 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 concernsexpressed by Federal and Provincial Health Departments about theadvertising and promotional practices of some pharmaceuticalcompanies in Canada. These concerns were similar to those

presented by Collier and Herxheimer and now under discussion byWHO. 1B

We require advertisements to comply with strict ethicalstandards incorporated in the PAAB Code of Advertising Accept-ance. The objective is to ensure the accuracy of pharmaceuticalinformation to health professions, in the ultimate best interest ofpatients-and the PAAB has a major role in the dissemination ofaccurate and useful pharmaceutical information in Canada. Theself-regulatory approach has proved effective.Our approach may serve as a useful blueprint for guidelines from

organisations such as WHO, the UK Medicines Commission, orthe International Federation of Pharmaceutical ManufacturersAssociations, either by self-regulation or with governmentsupervision. Although it is independent, the PAAB liaises with theHealth Protection Branch of Health and Welfare Canada. Thebranch is a non-voting member of the board and acts as adviser tous.

The PAAB office has an administrative staff of only fourpeople-a commissioner (a pharmacist with experience in the drugindustry), an assistant commissioner, and two secretaries/clerks.The board itself is comprised of eight voting delegates representingthe medical and pharmacy professions, consumers, the

pharmaceutical industry, the health media, and the CanadianAdvertising Foundation. Non-voting observers from thePharmaceutical Marketing Clubs of Ontario and Quebec and theAssociation of Medical Advertising Agencies also attend boardmeetings. Operating expenses are met entirely throughadvertisement review fees. The range is from$100 to$325, the lattercovering a full journal advertisement. During 1986 1337

submissions were reviewed. About 90 % required some amendmentbefore approval. However, only 10% needed extensive discussionand negotiation, which are essential and integral parts of the reviewprocess. The two industry associations represented on our boardcover about 95% of the major pharmaceutical companies inCanada. Participation in the programme is very strong and onlyrarely does a journal advertisement appear without our imprimatur.Pharmaceutical Advertising Advisory Board,Pickering,Ontario L1V 1A1, Canada

JOHN O. GODDEN,Chairman

CLINICAL PHARMACOLOGY AND GERIATRICS

SiR,—The assessment of the risk/benefit ratio of drugs in elderlypatients is often difficult. Tognoni and Bonatil and Dr Carboninand colleagues (March 28, p 747) suggest that the methods ofclinical pharmacology be applied to elderly subjects before a drug ismarketed. This was also proposed at a meeting on normal ageingand clinical problems (Montreux, Switzerland, March 30 to April 2,1987). The proposed aims are to detect adverse drug reactions andto assess efficacy, taking into account associated diseases andmultiple drug regimens, before a drug is marketed for elderlypatients. Besides the difficulty of defining old age (chronological orphysiological?), the proposition of studying prospectively all

possible multiple disease/multiple drug interactions in phase II orIII is not feasible, if only because of the number of patients to bestudied.

Assessing the incidence of side-effects from premarketing studiesis possible if the side-effect is frequent (a few percent of the patientstreated), but to evaluate the incidence of rarer events, the number ofpatients that has to be studied increases by thousands. This numberis hard to obtain in homogeneous young patients, and becomesimpossible to obtain in elderly patients, especially if one wants tostratify by associated diseases and/or drugs..

Pharmacokinetic studies should be done for baseline values innormal elderly volunteers and perhaps in patients with singlediseases, as well as phase II dose-ranging studies. These studiesshould 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 thenational pharmacovigilance system in France. From the reportsthey receive, problem areas can be defmed and studied, eitherprospectively with phase II and III methods, or with

epidemiological methods. Prescription-event monitoring can alsobe used.The limitation of the system is under-reporting. Physicians must

be reminded that side-effects in elderly patients are frequent, oftenatypical, misleading, or attributed to old age (eg, depression,parkinsonism, chronic organ failure). Reporting any untoward orunusual event in elderly patients taking new drugs is an act of publichealth. Using existing structures, which are usually staffed byclinical pharmacologists and epidemiologists trained in adversedrug reaction monitoring and evaluation, is more cost-effective thancreating new systems.

Hôpital de Boisguillaume,76230 Boisguillaume, France NICHOLAS D. MOORE

1. Tognoni G, Bonan M. Second-generation clinical pharmacology. Lancet 1986; ii.

1028-29.

MEDICAL CARE FOR THE HOMELESS

SIR,-We were fascinated by the investigation of psychiatricillness among guests at the 1986 Crisis at Christmas Open by MrWeller and colleagues (March 7, p 553). We have worked in thesurgery (clinic) at this facility and recorded details of 45 consecutiveattenders on one day. By contrast with Weller’s case-fmdingapproach 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, physicaland psychiatric problems:

Acute problem 24

Respiratory disease 10Minor trauma 9Acute diarrhoea 4Thrombosed piles 1

Alcohol/drug abuse 12

Drug request 7

Syringe request 2Alcohol withdrawal 2

Overdose 1

Chronic disease 14Chronic skin condition 6

Drug request 3

Lymphadenopathy 2

Chronic pancreatitis 1Diabetes 1

Amputation problem 1

Psychiatric disease 4? Munchausen’s syndrome 2

Chronic schizophrenia 1Panic attack 1

Most problems were acute though acute respiratory tract

infections, for example, were commonly on a background of chronicchest disease. Minor trauma, including 1 case of cold injury, wascommon. There was a suspicion that the 2 men seeking treatmentfor acute diarrhoea abused opioid medication but this was

unproven. The most common chronic physical complaints wereskin conditions, including leg ulcers and infestation. 1 man had

stump problems following an amputation but had apparentlyalienated himself from the limb-fitting services. 3 men neededsupplies of maintenance medication as they had been unable toobtain prescriptions (phenytoin 2, digoxin/diuretics . 1, anti-

cholinergic 1).Whilst we were aware that some attenders had chronic

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