University retracts study that showed Diovan as more than just a hypertension drug.
If you hadn’t heard of the 2009 Kyoto Heart Study before, you might have by now. The clinical study of “the effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks” has hit headlines after findings that it was falsified.
Valsartan is a drug that dilates blood vessels and reduces blood pressure. In many countries, including the US, UK, Australia, and Japan, it is marketed as Diovan by Swiss pharmaceutical company Novartis.
The Diovan study, which was led by Hiroaki Matsubara, a now-former professor of cardiovascular internal medicine at the Kyoto Prefectural University, concluded in 2009 that the drug was also effective in preventing stroke and angina, compared with other hypertension drugs. Novartis is very strong in the Japanese market and the company’s sales division there, Novartis Pharma KK, used these findings to promote the drug amongst doctors.
However, in January the credibility of the data came into question. The university investigated the medical records of 223 of the 3,000 Japanese patients involved in the study and found that the records of 34 patients falsely stated that they may or may not have suffered a stroke. There was also evidence that a Novartis Pharma employee was involved in the study, a fact not listed in the original report and subsequently confirmed by Novartis in an official statement.
University officials, including its president Toshikazu Yoshikawa, retracted the study and publicly apologized saying that the data was manipulated and new statistical analysis shows that “Diovan was no more effective than other similar drugs in reducing the risks of stroke and angina” and that the study was falsified to possibly claim additional side benefits.
Similar Diovan studies conducted by other universities are now being investigated.
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