Daiichi Sankyo is in trouble with the U.K.’s Prescription Medicines Code of Practice Authority (PMCPA) yet again. But, while the firm was found to have brought discredit upon the industry, it went down swinging in a response that called out the “somewhat malicious and defamatory” wording of a series of anonymous complaints.
The complaints relate to Daiichi cholesterol-lowering drugs, Nilemdo and Nustendi, that cannot be used with simvastatin at doses of more than 40 mg a day. In 2021 and 2022, the PMCPA received complaints alleging Daiichi failed to adequately communicate the simvastatin contraindication in materials such as press releases, websites and guidelines cards—bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
The latest completed PMCPA investigation, which was triggered by a complaint sent in July 2022, covers sales aids and leave pieces used by reps promoting Nilemdo and Nustendi. According to the complainant, the materials “discussed combining Nilemdo and Nustendi with other cholesterol-lowering medications” without making the contraindication with certain doses of simvastatin obvious to prescribers.
“The complainant was concerned that representatives had not been trained properly or given clear briefing within the materials on mandatory contraindications around simvastatin and the need to mention these at all times when making claims about combining Nilemdo and Nustendi with other cholesterol-lowering agents,” the PMCPA wrote in its report on the investigation.
In response, Daiichi said the lack of specific information on the rep calls and sales aids that triggered the complaint prevented it from providing a precise defense. The company told the PMPCA that its sales reps went through an extensive initial training course and sent screenshots of promotional materials to show they presented contraindication details in a fair, balanced, accurate, objective and unambiguous way.
Daiichi told the PMCPA that it took measures after the original simvastatin contraindication investigation wrapped up in December 2021, including a recall of all content to add warnings to address the concerns. The series of subsequent investigations happened because “the complainant was essentially searching” for materials that predated the recall, Daiichi told the PMCPA.
According to Daiichi, the complaints featured “somewhat malicious and defamatory … wording directed towards the medical signatory team.” The company added that “if they were the complainant, they had clearly misled the Panel in the course of their complaints in their identity.”
“More concerningly, there had been no attempt to achieve resolution through inter-company dialogue, and at no point had the complaint been voiced directly to Daiichi Sankyo. It was disappointing that some individuals chose to use complaints to the PMCPA as a method of communicating their concerns which contradicted the spirit of the Code and Daiichi Sankyo’s responsibilities and autonomy as an industry to self-regulate,” the PMCPA wrote in its summary of the company’s response.
Daiichi, which added that it is creating a “psychologically-safe culture” where staff can speak up, refuted all allegations of code breaches but failed to convince the PMCPA. In line with its earlier rulings, the self-regulatory body concluded there was a risk that some patients on 40 mg or more of simvastatin may take Nilemdo or Nustendi, putting patient safety under threat, and noted the repeat offenses.
“The Panel noted that a number of concerns had been raised across a number of materials and breaches of the Code had been ruled. The Panel considered therefore that the repeated failure to comply with the Code on this matter was particularly serious and might prejudice patient safety and was such as to reduce confidence in, and bring discredit upon, the pharmaceutical industry,” the PMCPA wrote.