Thursday, July 25, 2013

GlaxsoSmithKlien and quality control in research and development in China

Earlier this week in the New York Times, they shed light on some of the issues facing GlaxoSmithKlien and their clinical research outsourcing in China and how they're facing issues with quality control.  Author Katie Thomas points out the fact that they're currently entrenched in a bribery and corruption scandal which centers in their research and development center in Shanghai.

When audited, it was found that:
...researchers did not report the results of animal studies in a drug that was already being tested in humans, a breach that one medical ethicist described as a “mortal sin” in the world of drug research. They also concluded that workers at the research center did not properly monitor clinical trials and paid hospitals in ways that could be seen as bribery.

There were situations where the results in animals weren't reported and drugs had already made their way to human testing, failing to properly use the animals as a guage for how safe the drug will be in human trials.  In a second audit, it was questioned whether or not patient safety was properly monitored and site monitors were in question as to whether or not they were actually monitoring the number of patients they were being paid to supervise.  Since then, GlaxoSmithKline has made a vow to correct and prevent these issues in the future and stated:

Glaxo said it had since tightened the payment procedures for clinical research coordinators. Referring to the current bribery investigation, the company said, “we have zero tolerance for any kind of corrupt behavior among our employees, suppliers and business partners and will take action wherever and whenever we find it.”

This fall at Partnerships in Clinical Trials Asia, we bring together some of the most experienced experts in clinical outsourcing to learn and share their experiences on conducting clinical trials in the Asia Pacific region.  Professionals from Bayer Healthcare, EISAI, Coviden, Merck, Sanofi Aventis and more to join us and discuss issues like these in the region.  For more information on the program, download the agenda.  If you'd like to join us, as a reader of this blog, when you register to join us in Shanghai and mention code XP1875BLOG, you'll save 15% off the standard rate.

How can companies learn from GSK and prevent these types of issues in the future?


Mitch Scurtu said...

GSK used to be on top of the food chain in the 80th, 90th and first half of the 20th. They used to be the Wunderking on the American market.
They were providing the FDA with top quality clinical databases ranging in error rates between 0.1% - 0.01%. FDA review times of GSK's NDAs was between 10 - 12 months while the industry average was 30 month.
Everybody in the pharmaceutical business were wondering how GSK can perform at those levels? How is all that possible?

You can almost draw a line between GSK's good times and the start of the bad times.
With the mergers, aquisitions, new management came in and they were laughing at the Glaxo old timers providing the FDA with clinical databases with error rates between 0.1% - 0.01%. That is the time when most old timers left the company and everything went straight down from there on. GSK went through a 5 - 10 years period searching for their clinical data management solution. They were discarding one after the other the data management systems as inadequate and search went on for the next solution.

GSK finally settled for Inform ignoring all the warnings: like Inform is complex, complicated and un-manageable.
“Experts say EDC software isn’t ready to support the clinical trial needs of large pharmaceutical companies and they are right” as per Jashua Walker and Michael Barrett (Business View Brief, June 13,2010).

All troubles and mishaps started beginning with Avandia and all the rest. Now this problem with China. Myopic again, GSK wants to tighten the financial controls to appease authorities and make this scandal go away? But will it go away if GSK keeps insisting in their current practices?

What would it take for GSK to go back to the good old days of 0.1% - 0.01% error rate databases? Glaxo invented the Intelligent Data Management Model that enabled their success in the past. As far as I am aware the science behind the Intelligent Data Management Model has not been refuted. Could it be that the old ways were the right ways and that this Intelligence Glaxo invented was only a casualty of business discontent?

Diane Dolinsky-Pickar said...

It seems to me that there is no substitute for a CRO providing reliable work and complete transparency, and in an environment where the social ethos may be different than Western principles, one must proactively raise the principles and expose the tricky issues again and again and again, so that supervision rests on transparency.

Jennifer said...

Thanks for your insights Mitch and Dianne!