Big Pharma commits “mortal sin” research in China

Executives at the British drug maker GlaxoSmithKline were warned nearly two years ago about critical problems with the way the company conducted research at its drug development center in China. http://www.nytimes.com/2013/07/23/business/global/drug-research-in-china-falls-under-a-cloud.html?hp&_r=0  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.“It’s cheaper to do research there,” said Eric G. Campbell, a professor of health care policy at Harvard Medical School. However, “I have absolutely no doubt that with cheaper research comes greater risk.”
One of the most troubling lapses — a problem the report labeled “critical” — involved a drug known as ozanezumab, which was being developed to treat patients with multiple sclerosis and Lou Gehrig’s disease.
The report revealed that the drug’s project leader belatedly learned the results of three studies of ozanezumab in mice. During their investigation, auditors came across six studies whose results had not been reported, even though early trials in humans were already under way.
“If that’s true, it’s a mortal sin in research requirements,” said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. “No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.”
Outside ethics experts said the report raised questions about whether patient safety was adequately protected. Auditors found that Glaxo employees failed to record whether research participants had signed new consent forms during the course of clinical trials.
The 2011 audit report warned of “reputational, financial and/or regulatory action risk where payments made to investigators regardless of actual work completed are perceived as bribery or corruption.”
Chinese investigators have said that Glaxo participated in a widespread bribery and corruption scheme in which the company used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: