What are the expectations with regard to using data on file?

The application of this clause is not limited to information or claims of a medical or scientific nature. It includes, among other things, information or claims relating to pricing and market share.

It should be borne in mind that claims in material must be capable of standing alone as regards accuracy etc. In general, claims should not be qualified by the use of footnotes and the like.

The following are areas where particular care should be taken by companies:

• claims for superior potency in relation to weight are generally meaningless and best avoided unless they can be linked with some practical advantage, for example, reduction in adverse reactions or cost of effective dosage

• data derived from in vitro studies, studies in healthy volunteers and in animals must not be used in a way that misleads as to its significance. The extrapolation of such data to the clinical situation should only be made where there is data to show that it is of direct relevance and significance

• absolute risk and relative risk. Referring only to relative risk, especially with regard to risk reduction, can make a medicine appear more effective than it actually is. In order to assess the clinical impact of an outcome, the reader also needs to know the absolute risk involved. In that regard, relative risk should never be referred to without also referring to the absolute risk. Absolute risk can be referred to in isolation

• economic evaluation of medicines. Any claim involving the economic evaluation of a medicine must be borne out by the data available and not exaggerate its significance. To be acceptable as the basis of claims, the assumptions made in an economic evaluation must be clinically appropriate and consistent with the marketing authorisation

• emerging clinical or scientific opinions which have not been resolved in favour of one generally accepted viewpoint must be referred to in a balanced manner

• hanging comparisons whereby a medicine is described as being better or stronger or suchlike without stating that with which it is compared must not be made

• price comparisons as with any comparison, must be accurate, fair and must not mislead. Valid comparisons can only be made where like is compared with like. It follows, therefore, that a price comparison should be made on the basis of the equivalent dosage requirement for the same indications

• statistical information, claims and comparisons must have a sound statistical basis. Differences which do not reach statistical significance must not be presented in such a way as to mislead.

Instances have occurred where claims have been based on published papers in which the arithmetic and/or statistical methodology was incorrect. Accordingly, before statistical information is included in material, it must have been subjected to statistical appraisal.

Care must be taken to ensure that artwork does not mislead as to the nature of a medicine or any claim or comparison and that it does not detract from any warnings or contra-indications. For example, anatomical drawings used to show results from a study must not exaggerate those results and depictions of children should not be used in relation to products not authorised for use in children in any way which might encourage such use.

Particular care should be taken with graphs and tables to ensure that they do not mislead, for example, by being incomplete or by the use of suppressed zeros or unusual scales. Differences which do not reach statistical significance must not be presented in such a way as to mislead.

Graphs and tables must be adequately labelled so that the information presented can be readily understood. When taken from published studies, the source of the artwork must be given (see also Clause 14.2). If a graph, table or suchlike is taken from a published study, it must be faithfully reproduced except where modification is needed in order to comply with the Code. In such circumstances, it must be clearly stated that the material has been modified. Any such adaptation must not distort or mislead as to the significance of that graph, table etc. Care should be taken not to mislead when expressing data as percentages; patient numbers should be included wherever possible. It should also be noted that if a table, graph etc in a paper is unacceptable in terms of the requirements of the Code because, for example, it gives a visually misleading impression as to the data shown, then it must not be used or reproduced in material.

The restrictions on the word ‘safe’ apply equally to grammatical derivatives such as ‘safety’. For example, ‘demonstrated safety’ or ‘proven safety’ are prohibited under this clause.

Clauses 6 and 18 may also be relevant.

The Code does not preclude the use of other companies’ brand names when making comparisons.

Comparisons with other products are usually made to show an advantage of the advertised product over its comparator. Provided that such critical references to another company’s products are accurate, balanced, fair etc and can be substantiated, they are acceptable under the Code.

The references referred to are those to published material, including the use of quotations, tables, graphs and artwork.

Superlatives are grammatical expressions which denote the highest quality or degree, such as best, strongest, widest etc. A claim that a product was ‘the best’ treatment for a particular condition, for example, could not be substantiated as there are too many variables to enable such a sweeping claim to be proven. The use of a superlative is acceptable only if it can be substantiated as a simple statement of fact which can be very clearly demonstrated, such as that a particular medicine is the most widely prescribed in the UK for a certain condition, provided that this is not presented in a way which misleads as to its significance.

In certain circumstances, ‘the’ can imply a special merit, quality or property for a medicine which is unacceptable under this clause if it cannot be substantiated. For example, a claim that a product is ‘The analgesic’ implies that it is, in effect, the best and might not be acceptable.

Similarly, care needs to be taken with the use of ‘unique’. Although ‘unique’ may sometimes be used to describe some clearly defined special feature of a medicine, often it may simply imply a general superiority. In such instances, it is not possible to substantiate the claim as the claim itself is so ill defined.

The benefit/risk profile of a medicine must be presented in such a way as to comply with the Code. Particular attention should also be paid to Clauses 6.1 and 6.4.