[Ip-health] Pharmalot/Stat News: Astellas suspended from UK pharma trade group for 'deception on a grand scale'

Zack Struver zack.struver at keionline.org
Tue Jun 28 12:37:00 PDT 2016


https://www.statnews.com/pharmalot/2016/06/24/astellas-xtandi-uk-pharma/

Astellas suspended from UK pharma trade group for 'deception on a grand
scale'

By ED SILVERMAN
JUNE 24, 2016

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.


-- 
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
keionline.org



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