Clause 7 - Information, Claims and Comparisons

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
• the use of data derived from in-vitro studies, studies in healthy volunteers and in animals. Care must be taken with the use of such data so as not to mislead 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
• reference to 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. Care must be taken that any claim involving the economic evaluation of a medicine is borne out by the data available and does not exaggerate its significance
  To be acceptable as the basis of promotional claims, the assumptions made in an economic evaluation must be clinically appropriate and consistent with the marketing authorization
• emerging clinical or scientific opinion. Where a clinical or scientific issue exists which has not been resolved in favour of one generally accepted viewpoint, particular care must be taken to ensure that the issue is treated in a balanced manner in promotional material
• hanging comparisons whereby a medicine is described as being better or stronger or suchlike without stating that with which the medicine is compared must not be made
• price comparisons. 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. For example, to compare the cost per ml for topical preparations is likely to mislead unless it can be shown that their usage rates are similar or, where this is not possible, for the comparison to be qualified in such a way as to indicate that usage rates may vary
• statistical information. Care must be taken to ensure that there is a sound statistical basis for all information, claims and comparisons in promotional material. 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 promotional material it must have been subjected to statistical appraisal.

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

Companies must provide substantiation following a request for it, as set out in Clause 7.5. In addition, when data from a clinical trial is used companies must ensure that where necessary that trial has been registered and the results disclosed in accordance with Clause 13.1.

Clause 7.6 applies to references to published material, including the use of quotations, tables, graphs and artwork.

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 authorized 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 their incompleteness 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 7.6). 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 promotional material.

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

The benefit/risk profile of a medicine must be presented in promotional campaigns in such a way as to comply with the Code. Particular attention should be paid to Clauses 7.2, 7.9 and 7.10.

Superlatives are those 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, if this is not presented in a way which misleads as to its significance.

In certain circumstances the use of the word ‘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 under this clause.

Similarly, great care needs to be taken with the use of the word ‘unique’. Although in some circumstances the word unique may be used to describe some clearly defined special feature of a medicine, in many instances 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.