AllTrials News - Out of 400 trials on ClinicalTrials.gov, 30% haven’t
reported results
A new study found that 118 of 400 clinical trials had not reported results four years later in either a journal or on ClinicalTrials.gov. The researchers randomly selected trials that were registered on ClinicalTrials.gov and listed as completed in 2008. They found that trials were equally likely to report results regardless of whether or not they were funded by industry.This is yet one more study to look at the reporting of clinical trial results. The best available evidence is still that around half of all clinical trials have never been published or reported their results.Dr Christopher Gill, the study’...
Source: PharmaGossip - July 16, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA's Social Media Guidance Webinar: A Third Guidance Needed for Mobile Devices?
Yesterday, the FDA hosted a public webinar to "further" the Agency's "communications with stakeholders, media and the public" about recently-published social media guidelines.Unfortunately, I did not learn of this until it was too late -- registration to attend was closed. So, I urged those attending to live tweet during the webinar using the #fdasm hashtag.If you read those tweets, you'll soon discover three things:First, there were so many technical difficulties, the whole thing seemed to be heading for an epic #FAIL. Eventually, however, people were able to hear what was being said.Second, wh...
Source: Pharma Marketing Blog - July 11, 2014 Category: Pharma Commentators Tags: #fdasm Guidance Mobile social media Source Type: blogs
Big Pharma pushes the Snake Oil approach
FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rulesShould a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules agains...
Source: PharmaGossip - July 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Servier distort competition
BRUSSELS — The European Union's antitrust body is imposing a fine of 428 million euros ($580 million) on France's pharmaceutical company Servier and five producers of generic medicines for distorting competition.The 28-nation bloc's executive Commission on Wednesday said Servier struck a series of deals with the producers of generic medicines to protect its bestselling blood pressure medicine, Perindopril, from price competition.EU competition chief Joaquin Almunia says Servier's practices of "systematically buying out any competitive threats" to protect its market was "clearly anti-competitive and abusive."The Commissio...
Source: PharmaGossip - July 9, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?
At the end of June, the FDA sent a Notice of Violation (NOV) letter to Dr. C (you can find his name in the letter), Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).Here's the ad in question:Unless Dr. C (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C...
Source: Pharma Marketing Blog - July 8, 2014 Category: Pharma Commentators Tags: 14 letters FDA Girl from Google Legal/Regulatory Source Type: blogs
Advocate Groups Reach Out to President's Science Advisors Ahead of
Antibiotics Meeting | Food Safety News
The President’s Council of Advisors on Science and Technology (PCAST) will meet Friday to discuss its work on antibiotic resistance and nanotechnology and to hear from speakers about oceans policy.A group of public health, consumer, and environmental protection organizations have sent a letter to PCAST expressing concern that the U.S. Food and Drug Administration’s Guidance for Industry #213 and a proposed Veterinary Feed Directive (VFD) rule do not go far enough in addressing antibiotic overuse on farms.By March, FDA had heard from 25 of the 26 drug manufacturers affected by Guidance #213...
Source: PharmaGossip - July 8, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
What is called "guolaosi" in Chinese and "karoshi" in Japanese?
Answer: http://arbroath.blogspot.it/2014/07/chinese-man-praised-as-being-example-to.html (Source: PharmaGossip)
Source: PharmaGossip - July 8, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Larry Husten writes
Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In ItalyIn response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck . The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.MSD Italy, the Italian arm of the company, sent two “cease and desist” letter...
Source: PharmaGossip - July 7, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Another Idea for Creating FDA-Compliant Promotional Tweets: Put the Carriage Before the Horse
In previous posts, I discussed a few different techniques that pharma marketers could use to create Rx branded promotional tweets that satisfy recently-published FDA guidelines.One such idea was to attach an image of the required important safety information (ISI) to the promotional tweet (see "A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance").I polled readers about this and a majority of readers who took my poll said, yes, it's possible that such a tweet would satisfy FDA guidance requirements:In discussions with the Twitter "pharma team," however, I learned that on small-screen...
Source: Pharma Marketing Blog - July 2, 2014 Category: Pharma Commentators Tags: #fdasm Cialis Drug Safety Guidance ISI social media Twitter Source Type: blogs
Tokyo prosecutor to charge Novartis Japan unit as well as ex-employee
over manipulating data
(Reuters) - Tokyo prosecutors said on Tuesday they will charge the Japanese unit of Novartis AG and a former employee in connection with allegations of data manipulation in promoting its best-selling blood pressure drug Diovan.The prosecutors office said in a statement that it had decided to arrest Nobuo Shiraishi on allegations he gave false data to researchers whose work was used for advertising. Shiraishi was initially detained in June.The prosecutor also said that Novartis Pharma KK, the Swiss drugmaker's wholly owned local subsidiary, will be charged in connection with the case under a provision that alleges responsib...
Source: PharmaGossip - July 1, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Investigators Face Trial Amid GSK Sex Tape Revelations
South China Morning Post’s Toh Han Shih reports that British/Chinese-American corporate investigator couple Peter Humphrey and Yu Yingzheng, who werearrested last summer during a bribery investigation into their clients GlaxoSmithKline, will stand trial in Shanghai on July 29th.Chinese prosecutors originally wanted to charge Humphrey and Yu with several offences, including some relating to illegal business operations.But they decided to drop all of them except for one of illegally buying information, a source close to the family said.Although each faced only one charge, they risked being jailed if found guilty, the ...
Source: PharmaGossip - July 1, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Will Twitter's Card Technology Allow Pharma Brands to Post FDA-Compliant Promotional Tweets?
In today's Pharma Marketing News, I reviewed three "workarounds" that might allow pharma marketers to post promotional tweets that satisfy FDA's recently published (18 June 2014) guidelines:Chain of TweetsTweets with Images (see "A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance")Twitter CardsRead "FDA Sets Up a Roadblock for Branded Rx Promotional Tweets" for the details regarding the first two options.Spoiler Alert: They both probably won't pass muster with the FDA.What about Twitter Cards?A little Twitter bird told me that Twitter Cards, which allow your tweets...
Source: Pharma Marketing Blog - June 30, 2014 Category: Pharma Commentators Tags: #fdasm Guidance Mobile Mobile Advertising social media Twitter Source Type: blogs
GlaxoChinaGate contd. - sex, lies and video - Who made and who leaked
the Mark Reilly Sex Tape?
A covert sex tape involving a senior executive and his Chinese lover was the trigger for a major investigation into corruption at British drugs giant GlaxoSmith-Kline, it was revealed yesterday. The video of married Mark Reilly and his girlfriend was filmed by secret camera and emailed anonymously to board members of the pharmaceutical firm. It led to an investigation that has rocked the £76billion company – which stands accused of bribing doctors and other health officials in China with £320million of gifts, including sexual favours from prostitutes, to persuade them to prescribe its drugs.Mr Reilly, who ran...
Source: PharmaGossip - June 30, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Dutch farmers use less antibiotics
The use of antibiotics in livestock in the Netherlands was further reduced in 2013. This is according to figures from the Dutch Authority of Veterinary Medicines (SDa). At the same time, an international conference is being held to further reduce antibiotic resistance.Photo: Henk RiswickBetween 2012 and 2013, the use of antibiotics in the Dutch pig industry dropped the most, by 30%. Also in the poultry sector, less antibiotics were uses - 25% less compared to 2012. In the veal calf sector, antibiotic use decreased by 15%. In the cattle industry, the antibiotic use remained stable. The decrease in the use of antibiotic...
Source: PharmaGossip - June 29, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Should FDA or Pharma Correct/Edit Drug Information on Wikipedia?
A New England Journal of Medicine (NEJM) Perspective ("Drug Safety in the Digital Age") suggests that the FDA "update or automatically feed new safety communications to Wikipedia pages." The authors cite this precedent: "In 2008, the FDA partnered with WebMD to bring public health announcements to all registered users and to quickly integrate this information into WebMD's suite of Web pages."The reason this was suggested is apparent from the following chart, which shows that FDA safety warnings were associated with an "82% increase, on average, in Google searches for the drugs during ...
Source: Pharma Marketing Blog - June 27, 2014 Category: Pharma Commentators Tags: Drug Safety FDA guidelines Wikipedia Source Type: blogs
