A press release has landed Daiichi Sankyo in hot water in the U.K. Pharma’s self-regulatory body found Daiichi prejudiced patient safety by failing to reference a contraindication, leading it to conclude that the Japanese drugmaker had brought discredit on the industry.
The discredit stems from the opening line of a release about the cholesterol-lowering drugs Nilemdo and Nustendi receiving a reimbursement decision in the U.K. In the release, Daiichi said Nilemdo is “a novel, first‐in‐class, oral treatment which lowers cholesterol, and can be combined with other oral treatments to help lower cholesterol even further.”
That statement is true but, according to the U.K.’s Prescription Medicines Code of Practice Authority (PMCPA), isn’t the whole truth. The problem? Nilemdo cannot be used in combination with simvastatin, an oral treatment for lowering cholesterol, given at doses of more than 40 mg daily.
Daiichi defended the wording of the press release, telling the PMCPA that the statement “was not intended for healthcare professionals and was approved for U.K. journalists only.” The opening line “was appropriate for the recipient audience,” Daiichi argued, and links to the Nilemdo and Nustendi summary of product characteristics (SPC) were available further down in the press release.
The PMCPA disagreed with Daiichi’s argument. Quoting the industry code, the panel said “claims and information must be capable of standing alone with regard to accuracy etc, and it was an established principle that companies could not rely on additional information within the SPC to qualify a claim or negate a misleading impression.”
Because simvastatin is a commonly prescribed lipid-lowering treatment, the contraindication “needed to be immediately apparent to health professionals in material which referred to therapeutic use of Nilemdo in combination with oral treatments to help lower cholesterol even further,” the panel wrote. A link to the SPC “did not negate the misleading immediate impression given in the body of the material.”
The panel’s decision to find that Daiichi brought discredit on the industry was underpinned by a belief the press release created “a risk that some patients on simvastatin >40mg daily might be inappropriately treated with Nilemdo.”