In an unusual step, the pharmaceutical industry trade group in the United Kingdom has suspended Astellas for a year after discovering the drug maker disguised the true purpose of a meeting held for doctors, and then senior executives compounded the infraction by withholding crucial information when asked to explain the arrangements.
“There was an institutional failure,” an oversight panel for the Association of British Pharmaceutical Industries concluded in a harshly worded, 41-page report. “This was one of the worst cases (the panel) ever had to consider. … Very senior staff at Astellas Europe had lied and there was deception on a grand scale which was appalling and shocking.”
The suspension had its roots in a meeting that the Astellas division in the UK held in Milan in February 2014 for more than 100 physicians. The company billed the gathering as an educational event to obtain advice about prostate cancer when, in fact, it was more of a promotional stunt designed to woo doctors who were targeted to become high prescribers for Xtandi.
One of those physicians filed an anonymous complaint with the ABPI’s Prescription Medicines Code of Practice Authority, which oversees voluntary industry practice guidelines, to say that the meeting discussed uses for Xtandi that had not been approved by regulators. The physician also complained that Astellas “was not truthful” about why the doctors had been invited.
The complaint prompted the PMCPA to investigate. The panel later discovered the physicians believed they expected to attend a meeting of a legitimate advisory board, and they had also been paid, although the amounts were not specified in the report. In its initial findings, the PMCPA took Astellas to task, and the drug maker was contrite and vowed to improve its practices.
But then, another shoe dropped.
An anonymous Astellas employee later filed a complaint after attending a meeting where an Astellas executive discussed the incident in a “very dismissive manner,” according to the report. This prompted the PMCPA to explore anew, only to learn that some senior executives did not fully explain what occurred or provide all the pertinent information to the industry panel in the first place.
“The account given to the PMCPA was knowingly false and intentionally misleading,” the panel wrote. And its appeal board, which reviewed the matter, “was appalled and astonished that senior managers from Astellas Europe had made a concerted attempt to deceive it and the PMCPA. … It was a truly shocking state of affairs.”
“The panel was extremely concerned and disappointed by the conduct of Astellas Europe and Astellas UK. The integrity of self-regulation relied upon the provision of complete and accurate information by pharmaceutical companies,” the report continued. “… the failure to provide all the information and the misleading nature of what was submitted … meant that high standards had not been maintained. The circumstances brought discredit upon and reduced confidence in the pharmaceutical industry.”
The findings come amid ongoing scrutiny of drug makers and their promotional practices, an issue that has prompted some industry trade groups to establish voluntary guidelines. It is rare, though, for the ABPI to suspend a company from its membership. There were at least three other instances: Between 2006 and 2008, Roche, Merck and Abbott Laboratories were suspended briefly for infractions.
An Astellas spokeswoman responded to ABPI’s claims, saying, “Astellas takes its responsibilities to uphold the letter and spirit of the ABPI Code of Practice very seriously and accepts fully the decision of the ABPI Board of Management. Astellas is committed to achieving the required standards of compliance necessary for APL to have its membership to the ABPI reinstated.”
As a result of the episode, the PMCPA noted that the Astellas European unit, which is headquartered in London, had replaced several senior personnel after subsequently conducting its own review.