Drug scientist faces probe at threatened Lothians lab

A SCIENTIST at an under-threat drug research facility in the Lothians is under investigation by the UK's medical regulator, the News can reveal.

The 45-year-old male employee at Aptuit, which has sites in Riccarton, Livingston and Bathgate, has already been reported to the procurator fiscal.

The Connecticut-based firm, which has announced plans to close the Riccarton and Livingston facilities, carries out mainly drug development and pre-clinical work, including toxicology studies.

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While the exact nature of the investigation is unknown, insiders have claimed two other members of staff have been suspended in recent years over "fraudulent manipulation" of data.

The Crown Office has confirmed that it has received a report from the Medicines and Healthcare products Regulatory Agency (MHRA) relating to activities between September 2005 and February 2008.

A spokeswoman for Aptuit, which took over the Quintiles site in 2005, said the firm called in MHRA investigators after discovering "certain isolated activities dating back to 2001".

It comes as First Minister Alex Salmond told MSPs he and Finance Secretary John Swinney would meet the firm's executive chairman and CEO Tim Tyson in the New Year to urge him to reconsider the decision to close the facilities.

A spokeswoman for the MHRA, an executive agency of the Department of Health, confirmed that the investigation remains ongoing.

She said: "The MHRA has submitted a report to the procurator fiscal at Edinburgh concerning a 45-year-old male, in connection with allegations of breaches of good laboratory practice regulations and good clinical practice regulations.

"Since this is an ongoing investigation, it would be inappropriate to comment further."

One senior Aptuit source said investigations by the MHRA had damaged the firm, although they believed it was a lack of investment in the Riccarton site which had led to it becoming obsolete.

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They said: "In recent years Aptuit's downsizing of its workforce in UK and investment in India has not helped the site, but recent irregularities in work and investigations by the MHRA, particularly in bioanalysis, saw a loss in sponsors and contracts from which it has been struggling to recover.

"Despite this, there are some very good staff who do extremely skilled work, and it will be a great shame ahead of Christmas to see them lose their jobs."

Aptuit blamed the decision on "the continued worldwide economic downturn and pharmaceutical market dynamics".

In response to the claims, a spokeswoman for Aptuit said: "Aptuit acquired the Riccarton facility from its previous owners in 2005.

"In February 2009, we discovered certain isolated activities dating back to 2001, which we immediately and voluntarily reported to the MHRA and fully investigated.

"The issues were handled by Aptuit transparently and appropriately at a company - and customer - level and we have fully co-operated with the MHRA in their investigation.

"Upon taking control of the facility, we put in place rigorous quality procedures and protocols, and we remain confident in the integrity and quality of all work conducted at this facility.

"As a company, we are committed to working collaboratively with pharmaceutical regulatory agencies, such as the MHRA, and adhering to all regulatory requirements and best practices."