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Lilly told to withdraw diabetes leaflet

The Medicines and Healthcare products Regulatory Agency has forced Eli Lilly to withdraw a leaflet it produced with input from a diabetes charity

The Medicines and Healthcare products Regulatory Agency (MHRA) has forced Eli Lilly to withdraw a professional advice leaflet about diabetes and mental illness, because it failed to mention both the pharma company involved and the possible side effects of its antipsychotic drugs.

The removal of the advice leaflet, which was written with input from the charity Diabetes UK and aimed at healthcare professionals, has also raised questions about how much legal muscle MHRA has to clamp down on covert marketing and misleading information through pharma firm-patient association collaborations.

According to MHRA, another health charity alerted it to the leaflet in May 2005, having noticed that Lilly had failed to declare its involvement by placing its logo on the leaflet. However, the Diabetes UK logo remained on the leaflet.

ìAs soon as we were made aware of the complaint, Eli Lilly withdrew the leaflet on our request, based on the fact that the leaflet could be mistaken for a Diabetes UK publication,î said Diabetes UK spokeswoman, Sarah Dickinson.

More seriously, the charity was concerned that the leaflet failed to mention the increased risk to patients of hyperglycaemia and diabetes when taking schizophrenia medicines including Lillyís $4.2bn-a-year drug, Zyprexa.

Lilly has agreed to issue a corrective statement on its own website as well as that of Diabetes UK.

Lilly UK spokesman Dominic Wake said that as soon as the company was contacted by MHRA, it had voluntarily and immediately withdrawn the leaflet.

ìAfter reviewing the leaflet, it was clear that the fact that Lilly was involved in it was not explicit,î he said. ìThatís an oversight from Lilly ñ we do have processes in place to pick up on this sort of thing but that didnít happen in this instance.î

When asked why Lilly had only published the corrective statement in the password-protected section of its website, Wake said the company wanted to make sure it was compliant with the ABPI Code of Practice and not put information into the public domain that might cause it to be in conflict with the Code.

While both the ABPIís regulatory arm, the Prescription Medicines Code of Practice Authority (PMCPA) and MHRA have been at pains recently to emphasise their commitment to tackling unethical drug promotion, they have tended to concentrate on the more traditional areas of sales, marketing and advertising.

MHRA has stressed that its actions with regard to the Lilly leaflet are not backed by legislation and that it had to come to an ìagreementî with the company on how to resolve the issue.

ìThe collaboration of a pharmaceutical company and a patient group is not usually the area our advertising department deals with,î said MHRA spokeswoman, Silke Thomson. ìThis is not a breach of medicines legislation so we were operating in a kind of legal loophole where we had to set a precedent. This is why it took us so long to agree a corrective statement with Lilly.î

Lilly said the leaflet had been written to help healthcare professionals, particularly those working in psychiatry, to understand the increased risk of diabetes in people with severe mental illnesses such as schizophrenia and bipolar disorder.

30th September 2008

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