How commercial promotion affects the use of medicines: from Evidence to Action Andrew Herxheimer, Joel Lexchin

Why the WHO/ HAI database on pharmaceutical promotion? (1) to document how much drug promotion is inappropriate to document the health impact of inappropriate promotion to identify topics not so far studied to recommend needed research

Why the WHO/ HAI database on pharmaceutical promotion? (2)  to review tools for use in teaching health professionals about drug promotion; to provide tools to monitor drug promotion to facilitate networking by linking people concerned about promotion through the website

How it was built  by collecting the widest possible range of material describing, analyzing, reporting or commenting on any aspect of pharmaceutical promotion :  articles, letters, news in various journals* magazine articles* articles from drug bulletins/newsletters unpublished reports/studies videos radio/TV reports with accessible transcripts theses guidelines from diverse professional sources books & chapters from books then analyzing and reviewing all this material * BUT few from industry publications

New drugs are the major problem – they are the most heavily promoted  they are expensive there is still little experience of their use in practice outside clinical trials the safety profile is not yet well established

Persuading doctors, pharmacists, and the public to use a new drug requires strong advocacy – like any other sales promotion  Advocacy is one-sided – no balanced comparisons with alternative treatments. Claims are bold, disadvantages played down or ignored, but plain lies are unusual.

My caricature of pharmaceutical promotion:  The truth, the half truth, and nothing like the truth

Analysing claims and the data that may support them takes time and skills – most doctors lack both  Anyone interested can learn the skills – courses in evidence-based medicine are a good starting point, & clinical pharmacology helps

Conclusions (1): Doctors’ attitudes to promotion Attitudes vary, and don’t necessarily match their behaviour. Their opinions differ on the value of reps. Most doctors think information from drug companies is biased, but many think it is useful. Most find small gifts from drug companies acceptable, & believe that drug reps or gifts do not influence them personally, but do influence many colleagues. Few patients know that doctors receive promotional gifts. Doctors who rely on promotion tend to be older, less conservative, see more patients, are GPs rather than specialists, have less access to peers and have a more positive attitude towards medicines.

Conclusions (2): Effects on doctors’ knowledge They often use promotional information about new drugs, and for drugs used outside their usual therapeutic field. Doctors in private practice, or who graduated long ago, are the heaviest users of promotion as a source of drug information.

Conclusions (3): Effects on doctors’ behaviour More promotion is associated with greater drug sales, promotion influences prescribing more than doctors realise, & they rarely acknowledge that promotion has influenced their prescribing. Doctors who report relying more on promotion prescribe more often, less appropriately, & adopt new drugs more quickly. Samples stimulate prescribing. Doctors who receive company funds tend to request additions to hospital formularies. Company sponsorship influences the choice of topics for continuing education, the choice of research topics, & the outcomes of research. It leads to secrecy, delays publication for commercial reasons, and conflict of interest problems. Researchers often don’t disclose funding from drug companies.

Countering bad promotion – what’s ineffective  Voluntary regulation, eg by industry Guidelines – for sales reps for post-marketing surveillance on conflict of interest in research for package inserts & compendia about gifts for trainee doctors & for hospitals

Countering bad promotion – interventions that work  Government regulation Training students – before & after graduation Media exposure of abusive promotion Giving abundant free & reliable therapeutic information to professionals and the public

Research has focused on health professionals – little has been done on consumers or patients  Phase 2 of the project will look at interventions for medical and pharmacy students, and studies evaluating them It is intended to update the database every 2 years

Industrialized v. non-industrialized countries  Much more research on promotion has been done in industrialized countries than elsewhere The problems and issues are basically the same everywhere But the appropriate and practicable solutions may not be the same A research strategy is needed for every region and every country

What should happen in the next 5 to 10 years? (in my opinion)  1. Governments should Remove responsibility for the pharma industry from the health ministry Fund the regulatory agency from the health budget, not from licensing fees Require balanced information, including clinically relevant comparisons, as well as present requirements, and clear warnings about adverse effects

At the same time Encourage pharmaceutical companies to join constructively in the development of national health policies to do research addressing important health needs ( educate politicians on this) to distinguish between real therapeutic innovations, & new products that offer no clear advantage over existing therapies ( educate politicians on this too)

An obvious but controversial suggestion Recognizing that promotion causes increased spending on drugs by government & citizens, introduce a modest levy of 5 to 10% on promotional spending, maybe only on promotion of new drugs, but not on promotion that supports national health policies and guidelines. Promotion must of course be clearly defined

2. Training students & graduates to evaluate therapies and claims  Programmes of education in evidence- based medicine (EBM) in schools of medicine and pharmacy EBM courses in the continuing education programme, including web-based distance learning Local and e-discussion groups, eg as part of journal clubs

3. Providing professionals and the public with abundant free & reliable therapeutic information  Funding or subsidising independent professional bulletins, formularies, compendia and information services as part of a national health information policy, eg in UK, Drug & Therapeutics Bulletin, British National Formulary, National electronic Library of Health, Therapeutic Notes In Oz, Australian Prescriber, Australian Medicines Handbook, Australian Adverse Reactions Bulletin

4. Media exposure of abusive promotion The aim would be (1)to discourage abusive promotion by expressing disapproval on behalf of the professions and the public, so influencing the company and its owners (2)To raise general awareness of the issues underlying the harmful behaviour

5. Benign competition and collaboration between countries?  Drug exporting countries have traditionally promoted and have tried to protect their pharma industry, which is politically powerful.  But these countries also want affordable drugs for their citizens – an unresolved conflict in many  Countries that do not export drugs, can more easily put public health needs first, but some don’t – these countries should collaborate  WHO, INRUD and many other NGOs are trying to bridge the gap, and need support

6. Research  Every country needs to understand the effects of promotion on its health system and its people  At present only pharma companies do research on promotion to help them sell expensive drugs – but the results are secret  Independent public research is needed to ensure that promotion does more good than harm