Novartis caught red-handed fabricating clinical trial data in Japan

Sunday, October 06, 2013 by: Jonathan Benson, staff writer
Tags: Novartis, fabricated data, clinical trials

(NaturalNews) Switzerland-based pharmaceutical kingpin Novartis is under investigation in Japan after two universities there recently caught the company engaging in scientific fraud. According to new reports, a former Novartis employee fabricated clinical trial data to exaggerate the benefits of the blood pressure drug Diovan (valsartan), which is currently licensed for use in more than 100 countries, and Japan's Ministry of Health is now trying to determine whether or not Novartis in any way violated Japanese law with its actions.

Earlier this year, five papers authored by the once prominent Japanese cardiologist Hiroaki Matsubara were retracted by the American Heart Association (AHA), including the main publication of the well-known 2009 Kyoto Heart Study. Not long after, the legitimacy of the Jikei Heart Trial, which was first published in The Lancet journal back in 2007, was also called into question. As it turns out, both clinical trials were worked on by former Novartis employee Nobuo Shirahashi, who failed to disclose his affiliation with Novartis while serving as a member of the statistical analysis organizations for both studies, and both studies were riddled with serious errors.

The issue generated considerable attention last year when Yoshiki Yui from Kyoto University Hospital's Department of Cardiovascular Medicine wrote a letter to The Lancet expressing concerns about some figures included as part of the Jikei Heart Study. According to his estimate, the reported averages and standard deviations (SD) for blood pressure levels across the various test groups were strange and seemingly unlikely to be legitimate.

"In the Jikei Heart Study, the coincidence of identical means and SDs for achieved SBP suggests that the normal distribution of the two groups is the same, because the normal distribution is determined by mean and SD; this is very odd," wrote Yui. "In other words, a randomized but heterogeneous population becomes homogeneous after a 3-year drug intervention. This ought to be the other way round."

You can read Yui's full letter here:
http://www.thelancet.com.

Two prominent Japanese universities say Novartis employee fabricated data

Since that time, it has become apparent that Shirahashi had been working for Novartis when the duplicitous data was published and had potentially fudged some of the study data intentionally in order to boost the profile for Diovan. Both the Kyoto Prefectural University of Medicine and the Jikei University School of Medicine seem to think this may have been the case, as they, too, reported finding evidence of data fabrication, according to Chemistry World.

"In August, the ministry of health launched an investigation, which has led to the retraction of several papers relating to Diovan's ability to prevent angina and stroke," writes Emma Stoye for Chemistry World. "Some hospitals have stopped offering the drug, and investigations are now underway at three other universities that hosted Diovan clinical trials."

Shirahashi has denied that he in any way manipulated study data, according to the India Times, as have the other researchers who worked alongside him. Novartis has also denied allegations that it was complicit in Shirahashi's purported misgivings, promising to cooperate with the Japanese government's investigation into the matter. But not everyone is convinced of Novartis' claimed innocence.

"Data was manipulated," stated Toshikazu Yoshikawa, president of the Kyoto Prefectural University of Medicine back in July about the Kyoto Heart Study. The university, which had earlier affirmed that Diovan can help lower blood pressure based on its findings, later reversed its position following the discovery of fraud. "We apologize for causing serious trouble," he added, vowing to "return his salary to take responsibility for the scandal."

Novartis, on the other hand, in typical drug company fashion, has admitted no responsibility whatsoever in the matter.

Sources for this article include:

http://www.rsc.org

http://articles.economictimes.indiatimes.com

http://www.forbes.com

http://www.thelancet.com

http://www.forbes.com