2013年4月30日火曜日

毎日新聞: Drug study scandal sending shockwaves through medical research community

毎日新聞: Drug study scandal sending shockwaves through medical research community

Drug study scandal sending shockwaves through medical research community

Following a deepening scandal in which a Japanese subsidiary of Swiss pharmaceutical giant Novartis was involved in clinical tests at universities for one of the company's best-selling drugs in a questionable manner, Japan's medical researchers fear the affair will taint all academic-drug industry partnerships.
The scandal erupted earlier this year when it was discovered that three academic papers by a Kyoto Prefectural University of Medicine research team studying the effects of the Novartis blood pressure drug Valsartan had been withdrawn over "major problems" with their claims.
It was also discovered that a statistician listed on a fourth paper by the team was an employee of Novartis Pharma K.K., Novartis AG's Japanese subsidiary, and furthermore that the company had donated more than 100 million yen in research funding to the team leader. Novartis Pharma was also using the withdrawn papers' conclusions -- that Valsartan reduced the risk of stroke and heart attack -- in advertisements and other promotional material.
"This is an era of cooperation between academia and industry, but we now stand to lose the public's trust because of this scandal," commented a representative of the Japanese Association of Medical Sciences (JAMS). What has JAMS nervous is not just the appearance of a conflict of interest, which researchers are already sensitive about, but that people now worry that "companies influence universities to produce clinical study results that will help boost drug sales."
In the Valsartan case, the universities and academic societies involved, along with Novartis headquarters, have all launched investigations into any irregularities with the clinical study, but it appears doubtful we will ever know the whole story.
On May 2, an article titled "Japanese Research Scandal Expands To A Second Trial And A Novartis Employee" was published on Forbes magazine's website. In other words, the Valsartan scandal is attracting global interest. The Forbes piece reported that the Novartis Pharma statistician was also listed on a completely separate Valsartan study written by a team at Jikei University and published by The Lancet medical journal in 2007 -- the results of which have also come under suspicion. The discovery deepened suspicions of shady connections between the company and researchers.
A March 29 entry at the news blog of British science journal Nature, titled "Novartis blockbuster linked to retracted papers," also quoted the Mainichi's March 28 report on Novartis' donations to Kyoto Prefectural University of Medicine research programs.
Novartis has a presence in 140 countries, and Valsartan has been approved in about 100 nations. In Japan, Valsartan has been a major hit, raking in more than 100 billion yen in sales annually. Marketing material for the drug in Japan leaned heavily on the claims of both the Kyoto Prefectural University of Medicine and Jikei University papers that Valsartan helps "prevent strokes, heart attacks and other ailments, making it a better option than other blood pressure medications."
Doubts were raised about the Kyoto Prefectural University of Medicine and Jikei University studies for two reasons. The first is the Novartis statistician, listed under his part-time post at Osaka City University instead of the company. In other words, a fact essential to ensuring the fairness and transparency of the papers was hidden.
At a May 24 news conference, JAMS Chairman Fumimaro Takaku called this "an inexcusable act and an obvious blunder.
"There is very little government support (for research) in Japan, so academic-industry partnerships are necessary, and we will be in trouble if clinical studies are delayed in this country because of the scandal," he continued. "It will be bad for Japan if transparency is not maintained" in these partnerships.
The second reason for doubt was the reliability of the clinical study results themselves. Last year, Kyoto University Hospital doctor Yoshiki Yui presented a paper claiming "the Kyoto Prefectural University of Medicine and Jikei University study results are statistically hard to credit." In fact, Kyoto Prefectural University of Medicine's papers were withdrawn from the journal of the Japanese Circulation Society (JCS) and a journal of the European Society of Cardiology after the publications pointed out "major problems with the data."
"There are sides to all this that make it natural to suspect data manipulation to help drug sales," Iwao Kuwajima, chair of the Japanese Organization of Clinical Research Evaluation and Review (J-Clear) NPO, told the Mainichi. "If some definite malfeasance is discovered, it would mean the company (Novartis Pharma) actually set out to profit through deception. That would be a very big problem indeed."
The shockwaves are being felt in hospitals and doctors' offices as well.
"The results of clinical studies are very important for deciding what medications to prescribe," said one 50-year-old Tokyo doctor. "Including any problem or arbitrary data in those results cannot be forgiven."
May 25, 2013(Mainichi Japan)


0 件のコメント:

コメントを投稿