British Trade Group Suspends Astellas After Drugmaker Disguised the True Purpose of a Meeting Held for Doctors
June 24, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – Shares of Japan-based Astellas Pharma are down more than 7 percent this afternoon after the company was suspended for one year by the Association of British Pharmaceutical Industries for misrepresenting an event it held for physicians in 2014.
According to StatNews, the drugmaker held a 2014 event in Milan, Italy for about 100 doctors initially billed as an educational event on prostate cancer. However, the meeting was actually more of a “promotional stunt” designed to encourage physicians to become high prescribers of the prostate drug Xtandi, enzalutamide. An anonymous physician who attended the event filed a complaint with the British association about the event. In the complaint, the physician decried the company for not being truthful about the nature of the event and also “say that the meeting discussed uses for Xtandi that had not been approved by regulators,” StatNews reported.
Sales of Xtandi, which was co-developed by Bay Area’s Medivation , grew 73 percent in the U.S. in 2015 and 116 percent globally. In addition to using Xtandi for prostate cancer, Medivation and Astellas have teamed up to explore its efficacy in treating triple-negative breast cancer. Earlier this month, the two companies launched a Phase III trial evaluating the efficacy and safety of enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic TNBC.
A division of the ABPI, the Prescription Medicines Code of Practice Authority, investigated and found that the physicians believed they were supposed to be attending an advisory board and not a marketing pitch.
Furthermore, the PMCPA found the attending doctors had received unknown amounts of financial compensation for their time.
After the investigation, Astellas management told the investigating body it would implement greater oversite practices of its events. However, a second investigation was prompted after senior Astellas officials are alleged to have dismissed the investigation during a meeting of senior company officials. Again, the agency was alerted to the matter by an anonymous source, but this time from an Astellas employee, StatNews said.
During its findings, the investigators said: “The account given to the PMCPA was knowingly false and intentionally misleading. 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,” StatNews said in its report, citing the PMCPA.
In response to the issue, Astellas replaced some of its senior management in its European unit, which is headquartered in London. An Astellas spokesperson told StatNews that it takes the PMCPA’s findings seriously.
“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,” the spokesperson said, according to StatNews.