Steve Eaton jailed in pre-clinical trial data scam

Steven Eaton, a former employee of Aptuit was found guilty at Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice Regulations 1999, was today sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials. - The first time the Medicines and Healthcare Products Regulatory Agency (MHRA) has successfully used these regulations to bring a prosecution.

The case came about when Aptuit informed the MHRA that they had identified serious irregularities in pre-clinical data generated to support human clinical trials and the registration of new medicines.

The irregularities involved changing or providing false analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects used to assess the safety and efficacy of a new medicine.

The MHRA launched an investigation to identify the number of studies affected and the impact the data irregularities would have on the interpretation of important safety data. The investigation concluded that Mr Eaton had selectively reported analytical data over a number of years, dating back to 2003. During this period he selectively reported data which was used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful when in fact it had failed.

The actions led to the review of many hundreds of safety studies assessing the impact of the data manipulation and to ensure that the compromised data was not used in future submissions to relevant authorities without their knowledge.

The development of a number of new medicines were significantly delayed and considerable cost to the study sponsors was incurred as a result of the delay due to the fraudulent activities of Eaton.

Following a full assessment by the MHRA’s inspection team and assessors it was concluded that the data integrity issues did not invalidate the results of the clinical trials that were affected.

Merck Opens New Manufacturing Facility in Hangzhou, China

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the opening of its new pharmaceutical manufacturing facility in Hangzhou, China. The facility, located in the Hangzhou Economic and Technology Area (HEDA), will package Merck medicines for China and the Asia Pacific region and will become a critical part of Merck’s global supply chain.

 

The new facility – a nearly US$120 million investment by Merck – deepens Merck’s growing research and development (R&D), manufacturing and commercial presence in China. Merck also has an R&D Center in Beijing, three manufacturing facilities throughout the country, a marketing and sales organization headquartered in Shanghai, and employs more than 5000 employees in China.

“Merck built its first China plant in 1994 in Hangzhou,” said Pam Cheng, president, MSD China. “Today, 20 years later, we are celebrating this new plant in Hangzhou that marks another milestone in our commitment to invest in China and further demonstrates the importance of China to Merck.

 

Facts about the new Merck manufacturing facility in HEDA

“The new facility in HEDA joins an integrated, interdependent network of 72 Merck facilities that supply medicines and vaccines to more than 140 countries,” said Mr. Deese. “The HEDA facility is one of the most advanced and largest packaging facilities in China and the region.” 

The new facility is 75,000 m² and is capable of holding up to 16 high speed lines to package pharmaceutical tablets and sterile Merck medicines that are used to manage diabetes, cardiovascular, infectious, respiratory and bone diseases. Packaging capacity is currently estimated at more than 300 million packages annually. Products used in Merck’s clinical studies and in its commercial activities to support future new product launches also will be packaged at the new HEDA plant. 

The new facility is fully compliant with the rigorous quality, environmental, safety and compliance standards that all Merck manufacturing facilities worldwide meet. The HEDA facility received a current Good Manufacturing Practices (cGMP) certification in January 2013. Protecting the environment was also a critical consideration in the facility’s construction – special air, waste and water management procedures and systems were built into the facility.