Novartis was not in breach of code for “inventing” disease

Editor—Ferriman's news item is incorrect on at least two counts.¹

Firstly, it is not true to state that the authority had imposed no penalty on the company for issuing misleading literature. Novartis, like all companies ruled in breach of the Association of the British Pharmaceutical Industry's code of practice for the pharmaceutical industry, had to undertake that the use of all relevant material and activity would cease forthwith and that it would take all possible steps to avoid a similar breach of the code in the future.

Novartis voluntarily withdrew the material before the Prescription Medicines Code of Practice Authority had been notified of Dr Robert Flowerdew's concerns and well in advance of Novartis being required by the authority to withdraw all relevant material. Four times a year the authority publishes detailed case reports in the Code of Practice Review. The review is widely circulated by the authority and is available on request. There is also some secondary publication of the reports. Publicity is seen as a major sanction. I anticipate that the report on this case will be published in this month's edition of the Code of Practice Review.

Secondly, the impression from the heading to the article, as above, is misleading. Novartis was not ruled in breach of the code for inventing a disease. Novartis was ruled in breach of the code for giving a misleading impression of the effect of Starlix on cardiovascular mortality and risk as detailed in the main body of the article.