Saying Sorry May Not Be Good Enough For Novartis
Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company’s role in the scandal. If necessary, ministry officials are prepared to raid the company’s offices in Japan. A Novartis official apologized to the Japanese public for the apparent manipulation of data. David Epstein, the head of the pharmaceutical division at Novartis, met with the Japanese health minister. ”We express our deep regret for the concern that the...
Source: CardioBrief - September 27, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized blood pressure Japan Novartis scientific misconduct valsartan Source Type: blogs
Forget The Apology: Japan To Raid Novartis Offices Over Diovan Scandal
Japanese authorities plan to raid Novartis offices after a health ministry panel concluded that the drugmaker should be held responsible for using falsified research to market its Diovan heart medicine. An interim report, which is expected to be released next week, will also estimate the financial impact that the studies had on national health insurance finances, suggesting penalties may be levied.
“The panel has been examining the possibility of exaggerated advertisements (for the drug), which is a violation of the Pharmaceutical Affairs Act, and will urge the government to take strict actions," against the Novartis uni...
Source: Pharmalot - September 27, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Novartis says sorry!
Novartis has apologised to patients in Japan over the alleged manipulation of data in five trials of its blockbuster blood pressure drug Diovan.
After meeting health minister Norihisa Tamura in Tokyo, the head of Novartis’ pharma division, David Epstein, said: “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry.”
In comments reported by Reuters, he went on: “We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion.”
There is no detail on what sanctions...
Source: PharmaGossip - September 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Novartis - Everyone freeze! This is a raid
Japanese authorities are preparing to raid the local arm of Swiss pharmaceutical giant Novartis over data fabrication claims, reports said Friday.
A health ministry panel of experts has concluded that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on a popular blood pressure drug, the Asahi Shimbun and other media said.
The studies suggested the drug -- sold under the name Diovan in Japan and licensed for use in more than 100 countries -- had some prophylactic effect on strokes and angina.
The firm used data from the studies to market its drug, playing up its...
Source: PharmaGossip - September 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We are quite busy this morning as we scramble to play catch up after dining with interesting sources last night. The routine never stops. And so, to cope, we are reaching for that treasured cup of stimulation and invite you to do the same. After all, there is much to be done. On that note, here is a new batch of tidibits. We hope your day goes well and do stay in touch...
How Cancer Drugs Can Skip Randomized Trials (Reuters)
Merck Halts Sale Of Combo Pill For Diabetes And Cholesterol (Philadelphia Inquirer)
Sanofi Cholesterol Drug Is Touted As A Potential Blockbuster (Reuters)
Pfizer...
Source: Pharmalot - September 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Lancet has formally retracted the Jikei Heart Study paper,
originally published in 2007
. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis NVS +0.43% blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.)As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki Matsubara. This ultimately led to a series of retractions of Matsubara’s papers and ...
Source: PharmaGossip - September 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Lancet Formally Retracts Jikei Heart Study with Valsartan
The Lancet has formally retracted the Jikei Heart Study paper, originally published in 2007. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.) As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki Matsubara. This ultimately led to a seri...
Source: CardioBrief - September 5, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes European Heart Journal Jikei Heart Study Lancet Novartis statistics valsartan Source Type: blogs
Lancet Formally Retracts Jikei Heart Study Of Valsartan
The Lancet has formally retracted the Jikei Heart Study paper, originally published in 2007. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.) As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki Matsubara. This ultimately led to a seri...
Source: CardioBrief - September 5, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes European Heart Journal Jikei Heart Study Lancet Novartis statistics valsartan Source Type: blogs
Novartis Hit by Scandal Over Japanese Drug Studies BY KANA INAGAKI
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.
http://online.wsj.com/article/SB100014241...
Source: PharmaGossip - August 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
After Novartis Scandal, Japan Considers Penalties For False Data
In the wake of the scandal over research for the Diovan blood pressure drug, the Japanese government is considering new legislation to regulate clinical studies. And penalties for failing to preserve and submit records to the government would include fines, having clinical trials halted and drug approvals may be rescinded, The Yomiruri Shimbun reports.
The Health, Labor and Welfare Ministry plans to establish a committee to investigate details of cases in which data was falsified and debate on the proposed Pharmaceutical Affairs Law is expected to begin later this week. Although there are ethical guidelines, Japan does not...
Source: Pharmalot - August 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Another University Finds Manipulated Trial Data For Novartis Drug
The scandal over research into the Diovan heart drug in Japan is beginning to resemble a game of Whack-A-Mole. One day after Novartis attempted to put the matter to rest by announcing its own investigation was completed, another university has disclosed that data in a trial was manipulated and the first author of the study, a professor at the university, says the work will be retracted.
In a press conference, Kazuhiro Hashimoto, who chairs an investigation committee at the Jikei University School of Medicine, indicated that a former Novartis employee might have manipulated the data, while noting that the former worker deni...
Source: Pharmalot - July 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
More Bad News For Novartis Blood Pressure Drug
In the last few days more bad news about valsartan (Diovan, Novartis) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug. The new events are only the latest problems for the drug and Novartis… Click here to read the full story on Forbes. (Source: CardioBrief)
Source: CardioBrief - July 30, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Source Type: blogs
New echo study raises questions; aspirin often added to warfarin in AF without CAD, despite bleeding risk; two types of pulmonary hypertension respond to novel agent; diovan data-manipulation scandal in Japan
(Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - July 29, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
New echo study raises questions; aspirin often added to warfarin in AF without CAD, despite bleeding risk; two types of pulmonary hypertension respond to novel agent; Diovan data-manipulation scandal in Japan
New echo study raises questions; aspirin often added to warfarin in AF without CAD, despite bleeding risk; two types of pulmonary hypertension respond to novel agent; diovan data-manipulation scandal in Japan (Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - July 29, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
