Pharmalot... Pharmalittle... Good Morning
PHARMALOT... PHARMALITTLE... GOOD MORNING
Hello, everyone, and welcome back from the weekend. Hope you had a relaxing time and feel refreshed, because the usual routine of meetings and deadlines is resuming. To brace ourselves, we stopped at a favorite grocery to stock up on the necessary ingredients to brew countless cups of stimulation. Our flavor today is Pumpkin Spice. So please grab your own cup of something stimulating and join us. Meanwhile, here are some tidbits to get you started. Hope your day goes well and you conquer the world...
Glaxo Exec Returns To China As 18 Employees Are Detained (Bloomberg News)
Pfizer S...
Source: Pharmalot - July 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, the middle of the week is here. This offers us the opportunity to ask whether the proverbial glass is half full or half empty? While you ponder your preference, we are brewing another iced glass of stimulation, since the steam is already rising here on the Pharmalot corporate campus. Meanwhile, here are some tidbits. Have a smashing day, stay cool and stay in touch. Again, we would like to remind you that we accept classified information...
Teva Discloses CEO Pay After Settling Lawsuit (Globes)
Novartis Raises Forecasts Thanks To Lack Of Generic Diovan (Bloomberg News)
Roche And Novartis Say Not C...
Source: Pharmalot - July 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Japan vows action over claims of fabricated drug data
http://www.japantoday.com/category/national/view/japan-vows-action-over-claims-of-fabricated-drug-dataBusiness Jul. 13, 2013 - 06:25AM JST ( 3 )Swiss pharmaceuticals giant Novartis headquarter building is pictured on January 28, 2009 in Basel AFPTOKYO (AFP) —Japan’s health minister said Friday it was very likely that test data on a widely used blood pressure drug from Swiss pharmaceutical giant Novartis had been fabricated and falsified.Norihisa Tamura characterised as “extremely regrettable” an incident in which an employee of the world’s number two drug maker had hidden his affiliation ...
Source: PharmaGossip - July 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials
Following a long series of accusations, retractions, and the resignation of a prominent professor, it now is clear that data from a large Japanese study of valsartan (Diovan, Novartis) was fabricated. On Thursday officials at Kyoto Prefectural University of Medicine said that “had patient records been used in their entirety,” the Kyoto Heart Study “would have had a different conclusion,” reported AFB. In 2009 the Kyoto Heart Study investigators, including the chief investigator, Hiroaki Matsubara, reported that treatment with valsartan resulted in significant cardiovascular benefits independe...
Source: CardioBrief - July 12, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Hiroaki Matsubara Japan Kyoto Kyoto Prefectural University of Medicine Novartis scientific misconduct valsartan Source Type: blogs
Trial Data For Novartis Drug Was Manipulated: Japanese University
Several months after various scientific papers for the best-selling Diovan heart drug sold by Novartis were retracted and a prominent researcher, who was the principal investigator in most cases, resigned his position from Kyoto Prefectrual University of Medicine, school officials now acknowledge that the underlying data was manipulated. This amounts to an about face - in January, the university conducted a probe and maintained there were no "irregularities."
The research was begun in 2004 by Hiroaki Matsubara, a former professor at Kyoto who co-authored papers between 2008 and 2012. These included the Kyoto Heart study, w...
Source: Pharmalot - July 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Ranbaxy, Another Bad FDA Report & The Missing Generic Diovan
Once again, Ranbaxy Laboratories may be facing a showdown with the FDA. The troubled generic drugmaker, which only recently agreed to pay $500 million to the US Department of Justice to settle criminal and civil charges associated with a long-running manufacturing scandal (see this), recently received a poor inspection report from the FDA for one of its facilities in India.
The 483 report, which typically details various violations of good manufacturing practices, was issued earlier this year for a plant in Mohali, according to The Business Standard. And the report is significant in two different ways. For one, the report ...
Source: Pharmalot - June 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Diovan trials may have been run by Novartis staff
Several post-marketing clinical trials of the blockbuster blood pressure drug Diovan may have been run by employees of the drug’s manufacturer Novartis.
While the firm is not naming the employees or the trials by name, one is believed to relate to the cardiologist Hiroaki Matsubara, a former Kyoto Prefectural University researcher, who has had a number of his Diovan studies retracted in Japan, the US and Europe.
Another large trial, the Jikei Heart Trial, also came under scrutiny when it was revealed that a Novartis employee, Nobuo Shirahashi, was involved with both studies, but his only listed affiliation was Osaka Ci...
Source: PharmaGossip - May 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Novartis Admits Employees Participated In Independent Diovan Trials
For the first time since opening an internal probe into clinical trials run in Japan for its Diovan blood pressure drug, Novartis has acknowledged signs of wrongdoing. In a statement on its web site, the drugmaker has admitted that two employees had varying levels of involvement in clinical trials that were initiated by investigators but were supposed to have been independent.
“Our current understanding is that one of our former employees had varying levels of involvement in five investigator-initiated (Diovan) trials in Japan. In addition, a second former employee, who reported to the first former employee, had invol...
Source: Pharmalot - May 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Novartis Acknowledges Employees Participated In ‘Independent’ Trials
Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five trials. … The new statement from Novartis admits that “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator ...
Source: CardioBrief - May 23, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Clinical trial Japan Novartis scientific misdconduct valsartan Source Type: blogs
Japanese Research Scandal Expands To A Second Trial And A Novartis Employee
A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal. Now, however, questions have been raised about another clinical trial, the Jikei Heart Trial, which was published in the Lancet in 2007. (Matsubara was not involved in this trial.) Novartis, which manufactures valsartan (Diovan), the drug studied in both trials, has announced that it is M...
Source: CardioBrief - May 2, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics European Heart Journal Lancet Matsubara Novartis scientific misconduct valsartan Source Type: blogs
A “No portion control, no calorie counting” success!
Read Jim’s wonderful story of health and weight transformed, minus wheat:
I am a 61-year old male, retired (but still working part time) early childhood educator. I am 5′ 7″ and medium-framed. Picked up your book in August via Amazon after a Google search for “diet to lose abdominal fat.” My wife, an RN, had been concerned that the 25 lbs I had gained since my retirement in 2007 had gone straight to my gut.
For years I had been a recreational runner and had held a weight of about 185 lbs. Slowed down a bit in the 1990′s due to a diagnosis of fibromyalgia. Weight began to climb and, by r...
Source: Wheat Belly Blog - March 7, 2013 Category: Cardiology Authors: Dr. Davis Tags: Wheat-elimination success stories Source Type: blogs
European Heart Journal Retracts Main Paper Of The Kyoto Heart Study
This article has been retracted by the journal. Critical problems existed with some of the data reported in the above paper. The editors of the European Heart Journal hereby retract this paper and discourage citations of More… (Source: CardioBrief)
Source: CardioBrief - February 2, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics European Heart Journal European Society of Cardiology Kyoto Heart Study scientific misconduct Source Type: blogs
Pharmalot… Pharmalittle… Good Morning
Good morning, everyone, and how are you today? We hope the weekend was relaxing and invigorating, because now, the familiar routine of deadlines and meetings and all manner of busywork has returned. What can you do? So, to cope, we are brewing that needed cup of stimulation. Feel free to join us. After all, a pick-me-up is not a bad thing. Meanwhile, here are some tidbits to get you going. Hope your day goes well and you conquer the world…
California Legislator Vows To Curb Reckless Prescribing (Los Angeles Times)
Patients Are Rarely Told About Medication Errors: Study (Reuters)
Job Cuts Feared At AstraZeneca R&...
Source: Pharmalot - January 14, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbott Laboratories Abbvie AstraZeneca Contraceptives Diovan EMA Flu JJ Johnson & Johnson Layoffs Medication Errors Mesh Implants Novartis OTC Drugs Over-the-Counter Drugs Patents Prescription Painkillers Source Type: blogs
Two Retractions For Embattled Chief Investigator Of Kyoto Heart Study
The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s better known Circulation) has announced the retraction of two substudies from the Kyoto Heart Study. The papers, according to the editor, “contain a number of serious errors in data analysis.” Read my entire story on Forbes. (Source: CardioBrief)
Source: CardioBrief - January 8, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Hiroaki Matsubara retractions valsartan Source Type: blogs
