[Ip-health] FT: Novartis faces Japan probe over drug advertising

Thiru Balasubramaniam thiru at keionline.org
Wed Jan 8 22:57:43 PST 2014


January 9, 2014 5:04 am

Novartis faces Japan probe over drug advertising

By Jonathan Soble in Tokyo

Novartis <http://markets.ft.com/tearsheets/performance.asp?s=ch:NOVN> is
facing a criminal investigation of its marketing practices in Japan after
the country’s health ministry asked prosecutors to examine problems with
the way the Swiss drug group promoted a popular blood pressure medicine.

The ministry filed a formal criminal complaint with the Tokyo public
prosecutor’s office on Thursday. Ministry officials said it was the first
time they had taken such a step in response to allegedly misleading
advertising by a pharmaceutical company.

improper behaviour by an employee who was involved in all of the tainted
studies, but has denied that management ordered research to be doctored or
knowingly touted the drug based on inaccurate data.Several Japanese
universities that had conducted studies of the drug, Diovan, retracted
their research last year after finding what they said was falsified
clinical data.

Some Japanese hospitals stopped prescribing the best-selling drug last year
as a result of the controversy.

In a statement on its Japanese website, Novartis said it took the
ministry’s action “extremely seriously” and promised to co-operate with
authorities, though it stopped short of admitting any wrongdoing.

“We apologise deeply to patients, families, medical practitioners and the
Japanese people for causing great nuisance,” it said.

Novartis previously acknowledged that its employee participated in the
university studies without disclosing his affiliation with the company, a
potential conflict of interest, in published findings. It cut the pay of
senior managers in Japan in October over the incident, which it blamed on
sloppy internal controls.

It has broadly stood behind its claims for the effectiveness of Diovan,
however, noting that the results of separate clinical trials in the US and
other countries have not been challenged.

Global sales of Diovan have already fallen since 2011 after patents on the
drug began expiring in Europe and the US, opening it up to competition from
cheaper generics.

The patent on Diovan in Japan, which accounts for about one-quarter of the
drug’s $4.4bn in annual sales, is due to expire this year.

If charged and convicted of false advertising,
face a fine of up to Y2m ($19,000) – a comparatively meagre sum, although
the impact on the Diovan’s brand and sales would likely be far bigger.

In an extreme case, managers could be jailed for up to two years, though
prison sentences for such crimes are rare.

More information about the Ip-health mailing list