Friday, September 13, 2013

Lancet Retracts Jikei Heart Study Amid Scandals Involving Several Researchers And Journals

This is an example of how insidious the corruption is surrounding pharmaceutical drugs in this country. It's getting very hard indeed to trust the findings of studies published in respected peer-reviewed journals, let alone the science that does not make its way to such esteemed outlets.

The Lancet just retracted the Jikei Heart Study:

RETRACTED: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study, 2007

This retraction followed the retraction by the European Heart Journal of the Kyoto Heart Study in February this year :

RETRACTED: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study, 2009

Both of these studies found benefit for the blood pressure-lowering drug valsartan (Diovan, made by Novartis). Both had several authors in common.

There was an investigation at Jakei University about the Jakei Heart study. It found:
“We believe, therefore, that the data were intentionally altered.” ... “We suspect that the data were altered during their statistical analysis.”
The person responsible for the statistical analysis, Mr. Shirahashi, had taken an unpaid position with Jakei University for several years while being employed by and paid by Novartis. This conflict was not revealed in the study's publication.

Note that it took several years to investigate and formally retract these studies, during which time valsartan continued to generate profits. In 2005, Valsartan was prescribed more than 12 million times in the United States and global sales were approximately $6.1 billion in 2010. It almost doesn't matter that they get caught. Shirahashi recently retired from Novartis, and Novartis made their money on valsartan, the patent for which expired in September 2012.

Also, the senior author of the retracted Kyoto Heart Study, Dr. Matsubara, is at the root of several allegations of fraud involving published studies in the journals Hypertension, Circulation, and Circulation Research, all American Heart Association journals.


Bix said...

This brings to mind the famous quote by former NEJM editor-in-chief Dr. Marcia Angell in 2009:

"It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine."

Angela and Melinda said...

It's really pathetic, Bix, the state of our corporate oligarchy--and not just ours, but other countries too. Money talks, nobody walks, as the old ad used to say. Thanks for the quote!!!!

Bix said...

I don't think I would fill a prescription for a new drug. I'd wait for it to be on the market for a while. Too many drugs get marketed, make money, and then get tossed because of risks, Vioxx and Avandia come to mind.

I couldn't agree with you more. It's about making money. Business=Making Money. It's not about health.

Bix said...

That site Retraction Watch performs a great service.