Tuesday, February 12, 2008

Roche- Xenical: let's hear it for Ryta Kuzel

When Roche received large orders for Xenical, its prescription-only slimming medicine, from the operator of a chain of private diet clinics in 2002, suspicions were raised among staff.

Robin Huxley was soon accounting for most of Xenical's UK sales outside the NHS. Questions were asked inside Roche about how he could be attracting so many patients. But in the next three years, the pharmaceutical company offered him discounts and even direct financial support.

Roche stopped only after the Medicines and Healthcare Products Regulatory Agency launched an investigation in 2005, which led to Mr Huxley's guilty plea to breaches of the Medicines Act in December.

Roche argues that it was a victim.

But company documents give an unusual insight into the drug company's tactics in the private prescription medicines market.

The documents were submitted as part of an unfair dismissal claim brought against Roche by Dr Ryta Kuzel (pic), head of regulatory affairs, who examined the matter when the MHRA inquiry began.

More at FT

Here's an update from Ryta's lawyers: Link

During her time at the company, Dr Kuzel also raised concerns about the alleged unlawful packaging of UK products and described arriving at the company in 2003 to find sensitive clinical trial data dumped in an unfurnished basement.


"It included addresses and patients' details," said the claimant's counsel, Ruth Downing. "This is information that only a limited number of people should have access to under strictly supervised conditions."


Describing the incident as "human error," the respondent countered that Dr Kuzel's concerns about packaging, which they characterised as a regulatory grey area, were inflated and had been discussed extensively within the company.


Although the firm have conceded that they were wrong to summarily dismiss Dr Kuzel, whose office was sealed off after she was escorted from the premises last year, the size of any payout will hinge on whether the panel accept her claim of whistle blowing.


Under the Public Interest Disclosure Act 1998, employees sacked for exposing wrongdoing are eligible for much larger payouts than the £58 400 cap for victims of straightforward unfair dismissal, and awards can reach hundreds of thousands of pounds.

BMJ

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