Novartis gave doctors thousands to prescribe pills, feds allege
GooglePin ItOriginally published: March 15, 2014 7:41 PMUpdated: March 15, 2014 8:26 PMBy KATHLEEN KERR  kathleen.kerr@newsday.comAn illuminated logo sits above windows at Novartis AG's headquarters in Basel, Switzerland, on Tuesday, July, 16, 2013. (Credit: Bloomberg / Gianluca Colla)Dr. Howard Brand says he had one goal when he gave a speech at a Miami hotel in the early 2000s -- to tout the diabetes pill Starlix for the pharmaceutical company Novartis.The giant Swiss drugmaker, which reported $57.9 billion in global sales in 2013, paid the Stony Brook endocrinologist $1,500 for his talk at a doctors'...
Source: PharmaGossip - March 16, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Novartis gave doctors thousands to prescribe pills, feds allege
By KATHLEEN KERR  kathleen.kerr@newsday.comDr. Howard Brand says he had one goal when he gave a speech at a Miami hotel in the early 2000s -- to tout the diabetes pill Starlix for the pharmaceutical company Novartis.The giant Swiss drugmaker, which reported $57.9 billion in global sales in 2013, paid the Stony Brook endocrinologist $1,500 for his talk at a doctors' meeting, Brand said in an interview. Novartis also paid for Brand's airfare and his weekend hotel stay, he said."It was self-serving, but I also thought it was a benefit to patients," said Brand, who explained that his expenses-paid weekend in Flo...
Source: PharmaGossip - March 16, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets
Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows.Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012.Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million.And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 m...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Here’s Why Novartis’ Japanese Unit Was Raided
Last month, the Japanese Health Ministry filed a complaint against Switzerland-based drugmaker Novartis AG’s (NYSE:NVS) Japan unit after the company used allegedly false data to advertise for its best-selling blood pressure drug, Diovan, theWall Street Journal reports.Reuters reports that prosecutors in Tokyo broke into the company’s offices in Japan on Wednesday as part of a criminal investigation of the company following charges that the drugmaker violated the law by releasing misleading advertisements.The advertisements in question cited research which the Japanese Health...
Source: PharmaGossip - February 23, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Novartis Recalls Millions Of Samples Due To Packaging Glitch
Here is a headache no drugmaker wants to endure. Last July, Novartis began recalling a few million bottles of samples of different medicines that were distributed to physicians, because routine testing determined that a chemical used in shrink wrap packaging was found to leech into some tablets. The incident appears to be an unusual instance in which samples given to doctors have been yanked. The voluntary recall amounted to 127 lots of samples for three blood pressure treatments - Exforge, Tekturna and Diovan – as well as the Lescol cholesterol pill and the Stalevo Parkinson’s drug, although a Novartis spokeswoman was...
Source: Pharmalot - December 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novartis May Face Criminal Charges In Japan Over Diovan Research
The Japanese Health Ministry may file a criminal complaint against Novartis over the Diovan research scandal, according to reports. Last fall, you may recall, the ministry convened a panel that found the drugmaker should be held responsible for the imbroglio.  The drugmaker and several Japanese universities have been rocked by a series of retracted papers concerning the medication, a huge seller in Japan that reached $5.6 billion in worldwide sales in 2011 before generics became available. That was also when questions were first raised about Diovan research conducted there, as well as ties between researchers and Novartis...
Source: Pharmalot - December 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

A Japanese University Denies Diovan Research Was Manipulated
For the first time since the scandal erupted in Japan over Diovan research, one of the universities that ran clinical trials to gauge the virtues of the Novartis heart drug is denying any data was manipulated. Late last week, Nagoya University released an interim report refuting the charge, according to The Yomiuri Shimbun. The drugmaker and several Japanese universities have been rocked by a series of retracted papers concerning the medication, a huge seller in Japan that reached $5.6 billion in worldwide sales in 2011 before generics became available. That was also when questions were first raised about Diovan research c...
Source: Pharmalot - December 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

FDA official: “clinical trial system is broken” - BMJ
FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohenhow he believes the current research and development process is brokenThe clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak.For seasoned observers of the drug approval process, Marciniak will be a familiar name and his comments will come as little surprise. In his 11 years at the US federal agency, Marciniak has been embroiled in high profile controversies that have pitted...
Source: PharmaGossip - December 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Novartis Faces Criminal Complaint Over Diovan Research In Japan
For Novartis, the embarrassing scandal over Diovan research in Japan has taken another turn for the worse. A non-governmental organization has filed a criminal complaint that accuses the drugmaker of using manipulated clinical trial data, which was carried out by several universities, to exaggerate the benefits of the widely used hypertension treatment in its advertising, according to Yomiuri Shimbun. Medwatcher Japan charged that medical journals aimed at physicians and other health care providers ran advertising that cited the research and made misleading statements. And in doing so, the NGO claims that Novartis violated...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Another Japanese University Finds Faulty Diovan Research
Yet another Japanese university has concluded that a study of the Diovan heart drug sold by Novartis contains questionable data. The findings comes less than a month after a government panel found the drugmaker may have violated Japanese law by using faulty data to promote its widely used heart drug, an offense that could lead to various penalties (here is the report). The report by the Japanese health ministry followed disclosures earlier this year by Kyoto Prefectural University of Medicine and Jikei University, which ran two of five studies that touted Diovan as capable of reducing heart attacks and strokes, that data w...
Source: Pharmalot - November 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Hello, folks, and how are you today? The sun is peeking through the clouds hovering over the Pharmalot corporate campus this morning, where the short people are, as usual, hustling off to the school houses, the leaves are blanketing the grounds and the official mascots are chasing down wild animals. Quite a scene. As for us, we are hustling a bit ourselves since we hope to attend an interesting panel later, which will require us to close the laptop for a spell. Nonetheless, we have the usual line up of items for you to peruse. So here you go. Have a grand day and stay in touch... Reckitt Benckiser Starts A Strategic Review...
Source: Pharmalot - October 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Really?! Ranbaxy Wins FDA Clearance For Important US Facility
In a rare bit of good news for Ranbaxy Laboratories, the generic drugmaker says its Ohm Laboratories facility in New Jersey successfully passed an FDA inspection. The move is significant because the plant is the only Ranbaxy manufacturing facility that is permitted to supply products to the US market after three plants in India were prevented from doing so thanks to serious quality-control issues. The FDA endorsement means that Ranbaxy can use the Ohm facility to file for FDA approvals for drugs, such as a generic version of the widely used Diovan heart drug sold by Novartis (NVS). Ranbaxy had been expected to win agency a...
Source: Pharmalot - October 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novartis Worries Its Reputation Will Sink Over Diovan Scandal
To what extent the Diovan scandal in Japan will hurt Novartis remains unclear, but one executive concedes that the mess is not going to burnish the corporate reputation. The acknowledgment comes after a government panel earlier this week found the drugmaker may have violated Japanese law by using faulty data to promote its widely used heart drug, an offense that could lead to various penalties (here is the report). In his second set of public remarks in the past week, David Epstein, who heads the Novartis pharmaceutical business, again apologized and also noted Diovan sales have fallen in Japan. But he insisted he is more ...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

TOKYO — Health ministry to probe legality of Novartis claims on Diovan
The health ministry will investigate the Japanese unit of Novartis AG, Japanese media said Tuesday, after a ministry panel said it may have violated Japanese law when it cited studies based on manipulated data to promote its blood pressure drug Diovan.“Japan, as a part of its growth strategy, is pushing for high-quality clinical studies necessary to develop pharmaceuticals originating in Japan,” a ministry investigative committee said in a draft interim report.“This is a grave matter that could harm the national interest by seriously damaging trust in Japanese clinical studies both domestically and overseas.”The dr...
Source: PharmaGossip - October 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Novartis Diovan Marketing May Have Violated Japanese Law
The other shoe is getting closer to dropping in the Diovan scandal engulfing Novartis in Japan. A government panel has released a much-anticipated report indicating the drugmaker may have violated Japanese law by using faulty data to promote its widely used heart drug, an offense that could lead to fines and jail time. The report may also augur concerns about the veracity of other research conducted at Japanese universities that have relations with drugmakers. The report from the Japanese health ministry follows disclosures earlier this year by Kyoto Prefectural University of Medicine and Jikei University, which ran two of...
Source: Pharmalot - October 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs