_She worked for Novartis in Argentina_ Hmmm, as to the reason why your wife can not find an employer there in the US may be due to the firm's reputaion...It has happened in Japan, this Swiss pharma giant manipulates universty study datas in order to profit big. Gross sales figure over a US$ Billions a year just from this drug! See story below''' Novartis Hit by Scandal Over Japanese Drug Studies_ " TOKYO—Swiss drug giant Novartis AG faces a mounting problem in Japan, its second-largest market, where researchers have retracted studies that touted the benefits of the company's most popular medicine.
TOKYO—Swiss drug giant Novartis AG faces a mounting problem in Japan, its second-largest market, where researchers have retracted studies that touted the benefits of the company's most popular medicine.
Two university-led investigations into Novartis-related research discovered data had been altered to produce inaccurate results. Novartis denies involvement in the alleged research distortions, and stands by the efficacy of its blockbuster heart medicine Diovan.
At least eight Japanese hospitals have said they will stop prescribing the medication in the wake of the controversy. "It's morally problematic to keep using a drug that's faced questions on effects that have been its feature," one Tokyo hospital director wrote in a public statement.
"We apologize for causing a situation that could shake confidence in Japan's physician-led clinical research and for carrying out promotions" of Diovan that cited the flawed research, Yoshiyasu Ninomiya, president of Novartis's Japanese subsidiary, said at a recent news conference.
In the U.S., the research scandal appears to have had limited impact. Heart doctors say Diovan is a widely used drug for lowering blood pressure and to treat heart-failure patients and heart-attack survivors. "There is no reason to stop using this drug in suitable patients," said Steven Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic.
The U.S. Food and Drug Administration said Diovan, also known as valsartan, has been used to treat millions of patients in the U.S. for more than 15 years. "The drug has a well-established safety and efficacy profile," said Erica Jefferson, an FDA spokeswoman. "The agency has seen no new safety concerns with this drug."
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Novartis introduced Diovan in Japan as a blood-pressure lowering drug in 2000, and later promoted it for other benefits such as reducing the risk of strokes and heart failure, based on studies by five Japanese universities. But some independent researchers publicly challenged the findings from last year.
Over the past month, two universities repudiated the studies after investigations concluded data had been "manipulated," casting doubt on claims of Diovan's multiple benefits. One university investigation said the raw data for the clinical tests in one study didn't show reduced cardiovascular risks. Another investigation said raw data on patient blood pressure levels was likely altered during the statistical analysis phase of the study. The universities said their probes didn't reach firm conclusions about who altered the data.
The other three Japanese universities that conducted Diovan research have also opened investigations, but haven't yet finished. The health ministry launched its own probe this month.
The Novartis flap in Japan comes amid growing scrutiny world-wide of the veracity of medical research. Last year, 415 articles in scientific journals were retracted, up from 46 in 2002, according to Thomson Reuters Web of Science, an index of peer-reviewed journals.
"Retractions in articles on clinical medicine are increasing world-wide," said Tetsuya Tanimoto, visiting researcher at the University of Tokyo's Institute of Medical Science."From last year, there's been an increase in Japan of fabrication incidents that have grabbed headlines internationally," he said.
The Diovan research scandal also underlines the race to create and market blockbuster drugs that cure more than one ailment. "The drugs won't sell if it's just about lowering blood pressure," said Iwao Kuwajima, chair of the Japanese Organization of Clinical Research Evaluation and Review. "There was a competition [among drug makers] to prove that there were preventive benefits for strokes and heart attacks in addition."
Eric Althoff, a spokesman at Novartis headquarters in Basel, Switzerland, said that the company stands by Diovan's health benefits, citing unchallenged research that reached similar conclusions in tests performed in 25 other countries, including the U.S.
Novartis said it did have a "conflict of interest" in the Japanese studies, which it should have disclosed but "inappropriately" didn't. It knew that one of its employees took part in all five studies, yet, when listed in published articles, was identified only as a lecturer at Osaka City University, where he had a part-time job. He was involved in statistical analysis of two studies, and handled data presentation, research design and operation in the other studies, according to a Novartis panel.
Novartis said the employee left voluntarily in May after his contract ended. He couldn't be reached for comment.
In an email response toquestions fromThe Wall Street Journal, Mr. Althoff said there was no evidence of "willful manipulation or falsification of data" by the former employee.
The research questions come at a time when the Swiss drug maker is dealing with a 28% drop in sales world-wide of what was once its best-selling drug after patents on Diovan expired first in Europe in 2011 and a year later in the U.S. Sales of Diovan in Japan, where the patent will expire later this year, accounted for about one quarter of global sales of the drug, which totaled $4.4 billion in 2012.
With an estimated 40 million Japanese patients diagnosed with high blood pressure, the market for drugs treating that condition has emerged as one of the biggest and most competitive areas, said Mr. Kuwajima. In addition to Diovan, at least six other blood-pressure drugs known as angiotensin receptor blockers, or ARBs, are sold in the Japanese market, according to regulators.
The research controversy has unleashed criticism of Novartis in Japan. National broadcaster NHK aired a 26-minute program titled "The Suspicious Drug," looking into how the data manipulation occurred.
Japan's largest daily, the Yomiuri Shimbun, carried an editorial questioning whether there were "excessive cozy ties" between Novartis and one professor leading some of the studies.
Several hospitals have in recent weeks said they would stop giving the medication to their patients. "There are few reasons to prescribe valsartan when there are multiple other similar drugs," wrote Makoto Takagi, director of Tokyo Saiseikai Central Hospital, in a statement dated July 22. Also, in July, Hakuhohai Group, which operates six hospitals in western Japan and Tokyo, stopped using Diovan, citing "moral reasons."
—Jennifer Corbett Dooren contributed to this article.http://online.wsj.com/article/SB10001424127887323838204579000403952581982.html