MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'enhance'. Sat, 03 Sep 2011 02:22:56 +0100 http://www.medworm.com/index.php?rid=4266278&cid=t_164011_151_f&fid=35818&url=http%3A%2F%2Frecoveryissexy.com%2Fpositive-moods-for-recovery%2F This article may help.Humor is known to be therapeutic just as is music to set a mood.People who watch funny videos on the internet are not necessarily wasting time. They may be taking advantage of the latest psychological science—putting themselves in a good mood so they can think more creatively."Generally, positive mood has been found to enhance creative problem solving and flexible yet careful thinking," says Ruby Nadler, a graduate student at the University of Western Ontario. She and colleagues Rahel Rabi and John Paul Minda carried out a new study. For this study, Nadler and her colleagues looked at a particular kind of learning that is improved by creative thinking.Students who took part in the study were put into different moods and then given a category learning task ... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=4266278 Fri, 17 Dec 2010 17:57:00 +0100 4266278 http://www.medworm.com/index.php?rid=4077591&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0romZY8URVc%2F At the heart of the Vytorin scandal three years was a decision to change the primary endpoint in a key clinical trial, a move that called into question not only the integrity of the so-called Enhance study but the veracity of the drugmakers, Merck and Schering-Plough. The trial, of course, ended in failure (see this), raising questions about whether patients received sufficient benefit for a heavily promoted and expensive pill. Merck, however, may have learned a lesson. The drugmaker, which has since bought Schering-Plough, recently resisted a recommendation by the steering committee for another Vytorin trial called Sharp to redefine the composite endpoint, according to Sanford Bernstein analyst Tim Anderson, who notes that such a move “would actually make it easier for Sharp to show... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4077591 Mon, 18 Oct 2010 13:50:15 +0100 4077591 http://www.medworm.com/index.php?rid=3691112&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ-hNnZeY0T4%2F Former Schering-Plough ceo Fred Hassan and several former colleagues and board members are a step closer to providing sworn testimony about the notorious Enhance clinical trial for Vytorin, which raised questions about the effectiveness of the widely advertised cholesterol pill (back story). A federal judge this week denied yet another a bid to dismiss a shareholder lawsuit, which accused the group of playing shenanigans with the results. At issue, is whether Schering-Plough and Merck (which were partners) handled the release of the trial data properly, given a two-year delay, a brief change in the primary endpoint without consulting the lead investigator and huge stock sales by some Schering-Plough execs. The trial, by the way, found Vytorin wasn’t any better at reducing arterial plaqu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3691112 Wed, 23 Jun 2010 12:58:10 +0100 3691112 http://www.medworm.com/index.php?rid=3641142&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2F3sblmEAdA8M%2F The Boston Globe has a good article/ book review on the latest quasi-luddite attack on the Internet (an attack in the name of brain science no less, and with cool brain scans). The book in question: “The Shallows: What the Internet Is Doing to Our Brains.” The Internet ate my brain (Boston Globe) - Nicholas Carr says that our online lifestyle threatens to make us dumber. But resistance may not be futile The reporter, Wes Anderson, adds the proper perspective, in my view, by ending the article with: “Books and the Internet, literary culture and digital culture have coexisted for many years. It may be that an engaged intellectual life will now require a sort of hybrid existence — and a hybrid mind that can adapt and survive by the choices one makes. It may require a new ... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=3641142 Mon, 07 Jun 2010 17:23:59 +0100 3641142 http://www.medworm.com/index.php?rid=3159977&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FONs8D1Sbaiw%2F The drugmaker says that completion of the much-anticipated IMPROVE-IT study will now take place in mid-2013 instead of mid-2012 due to the pace of enrollment, the “accumulation of clinical endpoints to date” and 30 months of follow-up needed, according to a statement. Merck hopes the study, which began in 2005 and has so far enrolled about 16,000 patients, will show that its Vytorin cholesterol pill can outperform Zocor in preventing deaths, heart attacks and strokes. Vytorin combines Zocor with Zetia. Improve-It is supposed to resolve questions raised by the Enhance trial, which found Vytorin failed to show a benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and showed a statistically insignificant buildup. Vytorin did a better job of lowering LDL, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3159977 Mon, 11 Jan 2010 12:44:50 +0100 3159977 http://www.medworm.com/index.php?rid=3026906&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FshtFKZn8T4I%2F Prescriptions for both of Merck’s cholesterol pills - Vytorin and Zetia - fell last week, while scrips for Abbott Labs’ Niaspan rose following the results of the widely reported Arbiter clinical trial, according to SDI, a market research firm, Dow Jones reports. The Arbiter trial found that Niaspan helped reverse narrowing of the arteries in heart patients, while Zetia patients didn’t experience any significant changes (see here). Along with simvastatin, Zetia is a component in Vytorin. This was the second study in two years to question Vytorin’s efficacy. Since the controversy over the earlier Enhance trial, Vytorin and Zetia scrips have been in a perpetual slump. “There’s a lot of switching taking place,” Tim McGee, associate director of client s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3026906 Tue, 24 Nov 2009 22:27:59 +0100 3026906 http://www.medworm.com/index.php?rid=2977568&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBKf6UvLaxzA%2F The big drugmaker may encounter its third negative study result within two years for Vytorin and Zetia which, along with Zocor, is a component in the expensive cholesterol pill. The latest trial is scheduled to be presented this coming Monday at the American Heart Association meeting, and pits Merck’s drugs against Abbott Labs’ Niaspan, Bloomberg News notes. The results are likely to show that Niaspan unclogged arteries better than Vytorin, according to Leerink Swann analyst Seamus Fernandez and Wells Fargo Advisors analyst Larry Biegelsen, Bloomberg writes. If so, Vytorin and Zetia revenue may be reduced by $800 million yearly, or 20 percent, Fernandez forecasts. Since January, sales have declined $480 million, or 14 percent, to about $3 billion. A win by Niaspan may discourage ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977568 Tue, 10 Nov 2009 13:42:12 +0100 2977568 http://www.medworm.com/index.php?rid=2931286&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6qSn-qjUnrs%2F The move is the latest in a long-running effort by the Republican Senator from Iowa, who has been probing undisclosed financial conflicts of interest among academics who simultaneously receive grants from the National Institutes of Health and payments from drug makers for research or speaking. His latest letter to the NIH follows an article in The Chronicle of Higher Education that noted several academics with alleged research conflicts. In particular, he cited Dr. Christie Ballantyne of the Baylor College of Medicine, who received over $34,000 for consulting with Merck about the Vytorin cholesterol pill. At the same, Grassley writes, Ballantyne was listed on several NIH grants concerning cardiovascular studies (here’s one). According to current NIH regulations, which Grassley has ci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2931286 Tue, 27 Oct 2009 15:47:43 +0100 2931286 http://www.medworm.com/index.php?rid=2511976&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2F_61B2ooGmnw%2F Given the whole distracting "controversy" of whether Nintendo Brain Age "works" or not, I have started to use the following "brain teasers" in my talks in order to help the audience gain a more useful perspective of what is going on. They worked great both in the Medicare Readmissions Summit in DC a few weeks ago, and at the Games for Heath Conference last week. Q: How many soldiers in the US Army have gone through computerized cognitive testing before being deployed, and why? A: Over 150,000, in order to establish an objective starting baseline and identify potential PTSD and TBI problems upon their return Q: How big is the ongoing investment by OptumHealth, a division of UnitedHealth Group (UNH), in developing computerized cognitive assessments to inform cli... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=2511976 Wed, 17 Jun 2009 03:07:33 +0100 2511976 http://www.medworm.com/index.php?rid=2182550&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F02%2Fschering-plough-vytorin-magic-of.html The Condor writes:While outlining the path of inference that Senator Grassley first forged, back in February of 2008 (to deduce that Schering had acheived "functional unblinding" of the ENHANCE data), the plaintiffs, again in Manson (Case 08-397), offer perhaps the most succinct piece of skepticism I have yet read on the Schering ENHANCE disclosure delay (this is from another brief filed on last Friday -- full 50 page PDF file):. . . .Schering’s ability to disclose the purportedly unanalyzable ENHANCE results so quickly after Congress exerted pressure supports a strong inference of scienter. Defendants make no attempt to reconcile how the supposedly intractable data problems that led Schering to withhold the results for over twenty months were magically overcome after just a few weeks of... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2182550 Thu, 12 Feb 2009 09:34:00 +0100 2182550 http://www.medworm.com/index.php?rid=2160939&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FSharpBrains%2F%7E3%2F531109479%2F We present a very complex task, mixing different forms of stimuli (auditory, visual) under time pressure. - Designed for Transferability: The tasks can be designed in a way that do not allow for the development of task-specific "strategies" to beat the game. One needs to truly expand capacity, and this helps ensure the transfer of to non-trained tasks." brain age, Brain Training, brain training games, cognitive benefits, cognitive psychology, crossword puzzles, enhance intelligence, fluid intelligence, intelligence, Lieury, nintendo, Nintendo Brain Age, nintendo brain training, Rise of Nations, videogame (Source: SharpBrains) SharpBrains blogs http://www.medworm.com/rss/comments.php?id=2160939 Tue, 27 Jan 2009 23:14:48 +0100 2160939 http://www.medworm.com/index.php?rid=1802687&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fschering-plough-enhance-confidential.html Let's hope Carrie Cox is sitting down! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1802687 Thu, 18 Sep 2008 05:21:00 +0100 1802687 http://www.medworm.com/index.php?rid=1802690&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fschering-plough-enhance-dear-oh-dear-oh.html I do hope Fred Hassan is sitting down! 258. To reduce the possibility of the results being biased, clinical trials are often “double-blinded,” meaning that neither the patient nor the doctor (nor, with most trials, the pharmaceutical company sponsor) knows whether the patient is in the experimental group (i.e., the group taking the drug under study) or the control group (i.e., the group taking placebo or another drug with known effects in the study population). Despite the obvious (and intended) limitations of blinding a clinical trial, if certain data about the population in the trial are made available, it is possible to discern useful information about the trial’s results, even while the treatment assignments remain blinded. Recognizing this, on February 11, 2008, in the Second Se... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1802690 Wed, 17 Sep 2008 15:47:00 +0100 1802690 http://www.medworm.com/index.php?rid=1786181&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F388696033%2F There are at least four - count ‘em, four - issues that are plaguing Merck and prompting Sanford Bernstein analyst Tim Anderson to downgrade the shares. In an investor note this morning, he writes the stock has already hit his $36 price target and has little upside. Why? Let’s see… Reasons To Be Doubtful, Number One: The Singular allergy med. Prescription trends are lagging, there is an ongoing FDA safety review that could report out at year’s end (look here), and the potential that Teva does an ‘at risk launch of a generic next year; Reasons To Be Doubtful, Number Two: Sales trends for the Gardasil HPV vaccine have been weak for the last few quarters in the three territories reported by Merck (background here and here. Reasons To Be Doubtful, Number Three: Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1786181 Wed, 10 Sep 2008 14:06:03 +0100 1786181 http://www.medworm.com/index.php?rid=1780127&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FSharpBrains%2F%7E3%2F387263580%2F This article was written by Pascale Michelon, Ph. D., for SharpBrains. Dr. Michelon, Copyright 2008. Dr. Michelon has a Ph.D. in Cognitive Psychology and has worked as a Research Scientist at Washington University in Saint Louis, in the Psychology Department. She conducted several research projects to understand how the brain makes use of visual information and memorizes facts. She is now an Adjunct Faculty at Washington University, and teaches Memory Workshops in numerous retirement communities in the St Louis area. More articles on the topic: - A Multi-Pronged Approach to Brain Health - Overview of Nutritional Supplements and Brain Fitness Alzheimers, Alzheimers risk, Antioxidants, berries, brain diet, Brain health, citrus fruits, cocoa, Corrada, Curcumin, dark chocolate, DHA, enhance me... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=1780127 Mon, 08 Sep 2008 16:05:57 +0100 1780127 http://www.medworm.com/index.php?rid=1723653&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F371073340%2F The circumstances surrounding the recently released SEAS study, which unexpectedly revealed a few dozen cases of cancer and cancer-related deaths among patients given the controversial Vytorin cholesterol pill, is apparently angering the House Energy & Commerce Committee. As part of its ongoing investigation into how Merck and Schering-Plough handled clinical trial data surrounding the Enhance trial, the committee is now questioning conflicting data from the SEAS trial. For instance, the SEAS press release from Monday, July 21, 2008, indicated that there were 93 cancer cases among those taking Vytorin and 65 among those taking placebo. But a press release issued by Oxford University’s Clinical Trials Service Unit indicated there were 102 cancer cases among Vytorin users and 67 in t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1723653 Thu, 21 Aug 2008 16:40:00 +0100 1723653 http://www.medworm.com/index.php?rid=1717574&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F368975375%2F Is it possible? Have Vytorin prescriptions finally hit bottom? Maybe. Back in January, when preliminary results for the Enhance trial were released, scrips were about 1.8 million, but then sunk to 1.33 million in June. Last month, though, scrips rose about 90,000, according to a filing by Schering-Plough with the Securities and Exchange Commission. This happened despite the confusion over the recently released Seas trial, which failed a primary endpoint and, moreover, yielded a puzzling number of cancer cases. However, there is another way to slice the data (isn’t there always?) Although scrips were up for Vytorin and Zetia, both of which Schering-Plough and Merck co-market in a rather strained joint venture, scrips for the entire cholesterol market also rose to their highest levels ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1717574 Tue, 19 Aug 2008 12:01:38 +0100 1717574 http://www.medworm.com/index.php?rid=1664249&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fschering-plough-indictable.html Ouch! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1664249 Tue, 29 Jul 2008 22:02:00 +0100 1664249 http://www.medworm.com/index.php?rid=1645930&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fschering-plough-vytorin-bottom-line.html "We just don't have evidence here for a benefit for Vytorin," Dr Steve Nissen says. "Let's stick with the statins, because we know they work." BusinessWeek (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1645930 Tue, 22 Jul 2008 10:17:00 +0100 1645930 http://www.medworm.com/index.php?rid=1642648&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fvytorin-all-at-sea.html Oh dear! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1642648 Mon, 21 Jul 2008 22:14:00 +0100 1642648 http://www.medworm.com/index.php?rid=1643031&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FSharpBrains%2F%7E3%2F341474581%2F Welcome to Encephalon´s 50th edition, where you will find another superb collection of blog posts on all things Brain and Mind. Enjoy these contributions: Science & Technology Mind Hacks reports that Facebook ate my psychiatrist. We can learn about the benefits of social networking sites like Facebook, bringing great perspective to recent and misguided media speculation (fuelled by a recent talk at the Royal College of Psychiatrists). Vaughan, will you please report on the benefits of participating (and, better, hosting) Encephalon?. Dungeons And Dragons - Or Mazes And Monsters?: PodBlack Cat offers a thought-provoking review of the therapy (including self-therapy) applications of role-playing games such as the classic Dungeons And Dragons and the more recent massively multiplay... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=1643031 Mon, 21 Jul 2008 14:05:26 +0100 1643031 http://www.medworm.com/index.php?rid=1642651&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fheavy-seas-vytorin-publicity-stunt.html Some think so. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1642651 Mon, 21 Jul 2008 13:32:00 +0100 1642651 http://www.medworm.com/index.php?rid=1642836&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F341481583%2F Both Schering-Plough and Merck pushed back their second-quarter earnings announcements from this morning until after the stock market closes because Terje Pedersen, of Ulleval University Hospital in Oslo, Norway, will provide an update on the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. The drugmakers are hoping the study may provide some insight into clinical outcomes with Vytorin, at least among patients with aortic stenosis, which is a cardiac valve abnormality. There is, however, a debate about whehter SEAS will be truly meaningful, given the trial design, the endpoints being measured and that aortis stenosis is rather uncommon. Here is some background. And so it will be very interesting to watch how the preliminary info is spun by Merck and Schering-Plough, which have su... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1642836 Mon, 21 Jul 2008 12:09:35 +0100 1642836 http://www.medworm.com/index.php?rid=1635181&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F338373514%2F Just when the bottom might have seemed near…. The fallout over the controversial handling of the Enhance trial continues to hurt Vytorin prescriptions, which fell 5 percent last month, according to the latest filing by Schering-Plough with the Securities and Exchange Commission. The decline outpaced the falloff in the entire cholesterol market, which dipped 2 percent, which means Vytorin’s share of the overall cholesterol market is shrinking - 6.8 percent in June compared with 9 percent in January, when preliminary Enhance results were released. As you can see, Zetia scrips and market share are also declining. Perhaps it’s time for Schering ceo Fred Hassan to revive merger talks. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1635181 Thu, 17 Jul 2008 20:40:40 +0100 1635181 http://www.medworm.com/index.php?rid=1593817&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fquestion-for-merck-schering-plough.html Do they consider comparing clinical trial endpoint data between the study groups in a manner lacking specific identifiers as 'blinded'? Functional unblinding - a tutorial. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1593817 Tue, 08 Jul 2008 02:22:00 +0100 1593817 http://www.medworm.com/index.php?rid=1594002&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F329165106%2F A study showing Pfizer’s Lipitor cholesterol med was no better than a placebo in slowing artery thickening may raised questions about the imaging technique used both in that trial and in the controversial Enhance study that prompted doubts about the effectivness of Vytorin, Dow Jones writes. The results of the so-called Cashmere study were unexpected because previous studies have shown that Lipitor reduces the risk of heart attacks and cardiovascular events. And in a research note issued last Thursday, BMO Capital Markets analyst Robert Hazlett says this calls into question the reliability of the study’s imaging technique when used in certain patient populations. Moreover, the new Lipitor data may provide ammunition to those who defend Vytorin and Zetia, which are marketed join... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1594002 Mon, 07 Jul 2008 20:16:55 +0100 1594002 http://www.medworm.com/index.php?rid=1582936&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fdissecting-ezetemibe-and-enhance.html The manufacturer "has invested far more in marketing than in science". At present, ezetimibe’s mechanism ofaction is not fully understood, and its benefit—for now, only mild LDL-C reduction—is toouncertain for us to be spending $5.2 billion ayear for it. Its manufacturer is fortunate thatthe drug is even licensed, given the currentand seemingly appropriate regulatory changesunder which drugs introducing new therapeuticclasses are scrutinized more closely for benefit. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1582936 Sun, 06 Jul 2008 15:51:00 +0100 1582936 http://www.medworm.com/index.php?rid=1575639&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325913480%2F An FDA panel met for two days this week and voted 14 to 2 that diabetes drugs should be subject to additional testing to determine cardiovascular risk, a move that will end countless dollars to drug development. And so this testy exchange took place during the meeting between Steve Nissen, a commitee member and FDA critic, who pushed for the recommendation, and Enrico Veltri, a Schering-Plough exec, who gained notoriety with the controversial Enhance trial for Vytorin. Shortly after Nissen argued why the added testing is needed, Veltri objected, Forbes writes. “Perhaps having renal dialysis or going blind is worse than dying suddenly, which is quick, cheap and painless,” he said. Veltri objected that Nissen’s proposal would apply to all diabetes drugs, even if there was ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1575639 Thu, 03 Jul 2008 16:24:30 +0100 1575639 http://www.medworm.com/index.php?rid=1560815&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fschering-plough-enhance-busted.html Story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1560815 Tue, 01 Jul 2008 20:49:00 +0100 1560815 http://www.medworm.com/index.php?rid=1551897&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321312904%2F Could it be? Are they getting a divorce over Vytorin? No, sorry to excite you. But the drugmakers are ending their respiratory joint venture and their eight-year effort to market a combination of their Claritin and Singulair medications, which are used to treat allergic rhinitis. Here is the statement. You may recall that the FDA issued a non-approvable letter two months ago. At the time, the drugmakers said they were evaluating the FDA response, but provided no additional information, which is another way of saying they were also evaluating their options. Which party pulled the plug? They don’t say, of course. But relations between the two drugmakers has not been particularly warm and fuzzy these past few months, ever since controversy erupted over the handling of the Enhance trial ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551897 Fri, 27 Jun 2008 13:08:20 +0100 1551897 http://www.medworm.com/index.php?rid=1466288&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296962293%2F The Republican presidential candidate finally released his medical report and, not surprisingly, he takes a variety of meds - hydrochlorothiazide to prevent kidney stones; aspirin to ward off blood clots; Zyrtec for nasal allergies; Ambien CR, to help him sleep when traveling, and generic Zocor. But McCain used to take Vytorin until earlier this year, when the Vytorin controversy erupted. And it seemed to be working. His cholesterol level was high in 2003, with a total of 226, LDL of 139 and HDL of 35. After Vytorin, the LDL dropped to the low 80s, but he was taken off the med after the results of the controversial Enhance trial were disclosed. Instead, he was given simvastatin, or generic Zocor, which didn’t reduce his cholesterol by as much but was deemed “acceptable,” acco... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1466288 Sat, 24 May 2008 15:22:05 +0100 1466288 http://www.medworm.com/index.php?rid=1461241&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295879862%2F Last fall, a bill was introduced in the Senate called the Physicians Payments Sunshine Act that would require drug and device makers to disclose the amount of money they give docs through payments, gifts, honoraria, travel and other means. And just as a watered-down version was revealed, Lilly declared its support. Whether other drugmakers will follow remains to be seen. One reported sticking point - exemptions sought for payments to docs who do clinical research. But as part of a settlement last fall with the Department of Justice, five device makers agreed to post consultant payments on their web sites. Meanwhile, a few weeks ago, a dozen drug and device makers told Chuck Grassley, the Iowa Republican who co-sponsored the Senate bill, they would disclose grants to outside groups. Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461241 Thu, 22 May 2008 15:48:35 +0100 1461241 http://www.medworm.com/index.php?rid=1461248&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295281918%2F Early last year, Michael Bots of the University of Utrecht, delivered a report to the Merck/Schering-Plough joint venture that markets Vytorin. Bots was hired as a special consultant to review clinical trial data that was using an imaging technique to measure the thickness of plaque in the carotid artery. His January 26, 2007, report indicated the data was “fine.” However, the drugmakers were concerned about several issues regarding missing data points and the ability to read some of the data. So Bots suggested a few ideas, although the problems remained and, on November 16, 2007, an expert panel was convened in a Washington, DC, hotel to address them. But there was one thing the panel wasn’t given to review - Bots’ January report. We know all this because the admis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461248 Wed, 21 May 2008 19:52:03 +0100 1461248 http://www.medworm.com/index.php?rid=1461249&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295213854%2F Less than a month after the FDA rejected its experimental Cordaptive cholesterol med, the drugmaker has scuttled a study. And interestingly, the study was using the same technique to examine patient populations as the controversial Enhance trial that was supposed to have boosted Vytorin. The discontinued Achieve trial examined people with a genetic predisposition to high cholesterol and, like the Enhance study, measured the thickness of carotid artery walls using images, or cIMT. You may recall, Merck and Schering-Plough say they had difficulty deciphering data, which was their reason for repeated delays in releasing results. Of course, Vytorin was shown not to offer any improvement. “It was clear from the steering committee’s review of pooled data from recently completed cIMT ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461249 Wed, 21 May 2008 17:55:18 +0100 1461249 http://www.medworm.com/index.php?rid=1458525&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F05%2Fwondering-what-to-buy-fred-hassan-and.html How about a cartoon? Hat tip: PM (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1458525 Wed, 21 May 2008 15:40:00 +0100 1458525 http://www.medworm.com/index.php?rid=1451975&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F293494275%2F Should Fred return the cash? That’s the question raised by Forbes, which notes that the bonus would have been “endangered” had the Enhance study of the Vytorin and Zetia cholesterol pills been released in November 2006 or March 2007 as had been expected. The final release earlier this year has caused a sharp drop in the use of the two drugs and in Schering-Plough’s stock price. “It would certainly make me want to investigate the situation further, particularly if I was shareholder,” Paul Hodgson of The Corporate Library, a corporate governance research firm, tells the mag. “It would seem to me that given Hassan’s reputation for open-mindedness in terms of compensation, that if there were some doubts about whether he should receive a bonus, he... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1451975 Mon, 19 May 2008 13:38:53 +0100 1451975 http://www.medworm.com/index.php?rid=1426775&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F284988276%2F How many and from which offices? The filing with the Securities and Exchange Commission doesn’t specify. We asked a Schering-Plough spokeswoman for clarity, but until we receive a reply, we are left to wonder whether this involves a securities matter, healthcare reimbursement or, perhaps, both. To an extent, this is not surprising. As Schering-Plough notes in the filing, “Schering-Plough, the joint venture and/or its joint venture partner, Merck, have received a number of governmental inquiries and have been the subject of a number of investigations” concerning Vytorin. And most, but not, all of this has already been widely reported. “These include several letters from Congress, including the House Committee on Energy and Commerce, the House Subcommittee on Oversig... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426775 Wed, 07 May 2008 00:04:43 +0100 1426775 http://www.medworm.com/index.php?rid=1404197&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F279384627%2F Last Friday, Genzyme and Isis Pharmaceuticals disclosed that the FDA wants them to gather more data in order to win approval for a novel cholesterol drug. Specifically, the agency indicated that lowering cholesterol is an “acceptable surrogate endpoint” for using their mipomersen in patients with a rare, inherited form of high cholesterol. But an outcomes trial will be needed to win approval for other patients with high cholesterol. Such a trial can prove valuable if the outcome is achieved, but it’s also expensive and time-consuming because many more patients are needed to enroll. Interestingly, Zetia was approved six years ago on its ability to lower cholesterol, but actual outcomes data for Vytorin still isn’t available. We mention both drugs in the same breath... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1404197 Mon, 28 Apr 2008 13:20:34 +0100 1404197 http://www.medworm.com/index.php?rid=1393904&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F276105192%2F Wondering just what managed care and pharmacy benefit managers may be thinking about Vytorin and Zetia? A survey of 71 execs taken during the week immediately following the American College of Cardiology meeting finds that 67 percent felt there would be “no immediate change” to their coverage plans, according to Cognet-X, a healthcare research firm. The reason? The marketplace will make changes for them. About 84 percent expected prescribing to shift dramatically from Vytorin to generic versions of Zocor, or simvastatin. And roughly 53 percent expect more Crestor scrips to be written, while 38 percent foresee greater Lipitor utilization. But 81 percent said any changes would be made within six months. Here are some of the findings… – 18 percent expect a possible tier c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1393904 Wed, 23 Apr 2008 11:45:19 +0100 1393904 http://www.medworm.com/index.php?rid=1389198&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F274688926%2F The line is growing ever longer. First, the House Energy and Commerce Committee and the Senate Finance Committee opened investigations into the controversial Vytorin trial, known as Enhance. Then, the New York and Connecticut Attorneys General begin their own probes into the handling of study data and the marketing of the expensive cholesterol med. Earlier this month, New Jersey’s Anne Milgram, issued her own subpoenas to Merck and Schering-Plough, according to the Merck earnings statement that was released this morning. The subpoenas were dated April 4. The Vytorin study has attracted enormous attention because the drugmakers delayed results for nearly two years; briefly changed the primary endpoint without consulting their lead investigator; named an independent panel to review dat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1389198 Mon, 21 Apr 2008 12:53:07 +0100 1389198 http://www.medworm.com/index.php?rid=1388990&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F04%2Fmerck-price-of-enhance.html Around $300 million in lost sales in the first quarter of 2008.Tell 'em Mike. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1388990 Mon, 21 Apr 2008 12:53:00 +0100 1388990 http://www.medworm.com/index.php?rid=1386812&cid=t_164011_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F04%2Fvytorin-saga-contd-condor-speaks.html What a blog! Here we get some insights into its author as they answer questions:Smile -- I've NEVER worked for Schering-Plough; I am NO journalist. Did you ever see "Three Days of the Condor"? I am a. . . . reader, I guess. I've spent some time really "reading up" on SGP, over the past three months.Now, your questions do deserve answers, and I do have my opinions(!), but I want to be careful not to libel/defame any private person. I do think Dr. Bots was right. I think the data were "fine." I think it likely that Schering and Merck just didn't "like" what the data pretty-plainly implied. Note that I've echoed, and amplified, Sen. Grassley's publicly-aired concerns that the very-likely outcomes from even the "blinded" data, were discernible to a medically-trained eye, long-before the data w... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1386812 Mon, 21 Apr 2008 04:26:00 +0100 1386812 http://www.medworm.com/index.php?rid=1373838&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F270672430%2F So says Jim Stein, the University of Wisconsin cardiology professor who participated in an expert panel convened last year to examine the infamous Enhance trial data. Stein was the expert whose review of a hastily composed summary of the meeting last November was released last Friday by the House Energy and Commerce Committee (look here). And his proposed revisions included remarks suggesting the initial draft contained a laundry list of inaccuracies, exaggerations and questionable assertions by Schering-Plough and Merck, which jointly market Vytorin. The trial data was released this year and indicated that Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1373838 Tue, 15 Apr 2008 12:16:26 +0100 1373838 http://www.medworm.com/index.php?rid=1370871&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F269975440%2F On January 22, Schering-Plough and Merck announced they would briefly suspend Vytorin ads after the uproar over the disclosure the previous week of the Enhance trial. A spokesman blamed “mischaracterization and misinterpretation” of the study results, which found Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in a small group of patients with inherited high cholesterol. However, FDA officials had already begun signaling that consumer ads and promotional materials distributed to docs had to be changed. Although the agency had noted certain issues in 2005, they committed an oversight that now had to be corrected - in a prio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1370871 Mon, 14 Apr 2008 12:08:30 +0100 1370871 http://www.medworm.com/index.php?rid=1367989&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F268636881%2F Here’s another nugget from the leaked Vytorin documents released today by the House Energy and Commerce Committee. Last September 14, John Kastelein, the primary investigator for the infamous Enhance trial, writes an e-mail to Soren Christiansen, the general manager for the endocrine franchise at Merck, which jointly markets Vytorin with Schering-Plough. Kastelein is upset that he had heard nothing about an upcoming ‘consultant meeting’ to review the trial and plans to write Christiansen’s counterparts at Schering-Plough. So Christiansen writes an e-mail of his own to several others involved in the Vytorin venture to say that he’s “concerned with how Schering-Plough Research Institute is interacting with one of the most important customers…” ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1367989 Sat, 12 Apr 2008 02:16:25 +0100 1367989 http://www.medworm.com/index.php?rid=1366891&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F268586120%2F Last November 16, an expert panel meeting was held at the Omni Shoreham Hotel in Washington, DC, to review the results of the infamous Enhance trial that was designed to boost the prospects of the Vytorin cholesterol pill jointly marketed by Schering-Plough and Merck. The panel consisted of five outside experts and 11 employees of the drugmakers, which are being investigated by the House Energy and Commerce Committee for allegedly manipulating the trial data in order to maintain the multi-billion-dollar Vytorin cash cow. But the meeting notes contain a plethora of inaccuracies, exaggerations and questionable assertions by the drugmakers, according to notes written in the margins by Jim Stein, a University of Wisconsin cardiology professor and one of the outside experts. The notes and relat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1366891 Fri, 11 Apr 2008 20:44:00 +0100 1366891 http://www.medworm.com/index.php?rid=1361153&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266952930%2F Not us. A survey of 101 primary care docs conducted by Deutsche Bank analyst Barbara Ryan has predictably bad news for Schering-Plough and Merck - the results suggest “both additional abrupt and sustained declines for Vytorin and Zetia, and increased utilization of other statins, especially Crestor,” she writes in an investor note this morning. The findings, by the way, are supplemented with data from ImpactRx. Approximately 85 percent of the respondents in this survey were aware of the recent Enhance results, and about 75 percent expect that usage of Vytorin and Zetia will decline in their practices. (Our thought - where were the other 15 percent? Out of the country on a jaunt paid for by a drugmaker? How could they not be aware of the medical controversy of the moment?) Anywa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1361153 Wed, 09 Apr 2008 11:11:31 +0100 1361153 http://www.medworm.com/index.php?rid=1356368&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266454459%2F The Vytorin debate isn’t going away anytime soon. A key question, however, is what, if anything, might the FDA do concering the labeling for the cholesterol pill. Any negative change would, of course, further affect already declining prescription writing and could easily prompt insurers to reduce reimbursement. In an interview with FDAWeb, Janet Woodcock, the new head of the Center for Drug Evaluation and Research, is deliberately coy, but seems to suggest lowering LDL is a well-validated surrogate. And the controversial Enhance trial did show Vytorin could do that much. FDAWeb: With regard to the public uncertainty that seems to have arisen about LDL cholesterol lowering in the wake of the Vytorin/Zetia situation, how does FDA respond, if it chooses to, to such perceptional issues t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1356368 Tue, 08 Apr 2008 16:43:39 +0100 1356368 http://www.medworm.com/index.php?rid=1354207&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F265663271%2F A loaded question, no doubt. And the answer depends on who you ask. Late Friday, the National Lipid Association reacted to the ruckus over the Vytorin study by issuing a statement saying that “nothing in this study has changed our position about the necessity for lipid lowering or the need to treat patients to established National Cholesterol Education Program goals.” We were implored by some to mention this statement over anger at the ACC presentation last week of the Enhance trial, which found Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in a small group of patients with inherited high cholesterol. We were also asked w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1354207 Mon, 07 Apr 2008 13:39:21 +0100 1354207 http://www.medworm.com/index.php?rid=1347619&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263262512%2F Harlan Krumholz made quite an impression at the American College of Cardiology meeting on Sunday. As the head of a four-doctor panel assembled to review the controversial Enhance trial, the Yale University professor recommended Vytorin should not be used as a first or second-line therapy, spooking investors. Schering-Plough ceo Fred Hassan is lashing out. Last night, he told analysts “we were very disappointed with the way ACC unfolded. We hoped to see an open and balanced scientific discussion, and this did not happen.” Hassan hoped for debate and questions. In response to criticism that he unfairly dominated the proceedings, Krumholz wrote us last night to say: “It is so interesting that they call the recommendations biased - they are simply that we should stick with dr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347619 Thu, 03 Apr 2008 11:09:09 +0100 1347619 http://www.medworm.com/index.php?rid=1346244&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262918058%2F The drugmaker, which is reeling from the controversy over Vytorin and the ensuing drop in prescriptions, is closing plants and cutting 10 percent of its workforce of 55,000 in order to save up to $1.5 billion. The move also comes a few months after Schering-Plough bought Organon Biosciences and had already begun slashing jobs to reduce expenses by $500 million which, of course, means the latest problems contributed to the extra $1 billion in savings targeted. “The whole company is built around cholesterol,” Hassan says in a teleconference. At least $1.25 billion is slated to be wrung out of operations by 2010, and the rest by 2012. To achieve these goals, ceo Fred Hassan wants to consolidate management; use more shared staff support and services; reduce travel; cut sales and ma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1346244 Wed, 02 Apr 2008 22:51:01 +0100 1346244 http://www.medworm.com/index.php?rid=1346249&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262770902%2F The answer may not be known for weeks, even months, but already one big insurer is pulling back and two big pharmacy benefits managers will review their reimbursement policies. In other words, the money machine that was Vytorin may be on the verge of unraveling. For instance, Cigna will no longer recommend Vytorin as an alternative for patients who currently use higher-priced cholesterol drugs that aren’t covered. “That particular step therapy is being suspended,” a Cigna spokeswoman tells The Star-Ledger of New Jersey. The insurer’s pharmacy and therapeutics committee will decide later about any further changes. And UnitedHealth will also conduct a review. “As of now we aren’t making any changes but we’ll clearly review the evidence as it’s ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1346249 Wed, 02 Apr 2008 16:44:21 +0100 1346249 http://www.medworm.com/index.php?rid=1344610&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262602842%2F Over the past several years, a big stink has been raised about conflicts of interest, such as when doctors write papers about a particular drug and also serve as a consultant in some fashion to the company who makes the medicine. Right or wrong, pharma regularly defends such situations by explaining that the best specialists are in demand. Generally, drugmakers shrug off the criticism. Now, though, Fred Hassan is trying to use such a situation to his advantage to deflect the controversy over the Vytorin cholesterol pill. A panel at the American College of Cardiology conference on Sunday was largely dominated by Yale University’s Harlan Krumholz, who skewered the results of the controversial Enhance trial by saying the drug shouldn’t be used as a first or second-line therapy. Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344610 Wed, 02 Apr 2008 11:36:06 +0100 1344610 http://www.medworm.com/index.php?rid=1340924&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F261580582%2F As part of its ongoing investigation into the Vytorin controversy, the Senate Finance Committee is disclosing angry notes written by John Kastelein, who was the primary investigator for the Enhance trial, which found the cholesterol pill was something of a dud. The costly combination of Merck’s Zocor and Schering-Plough’s Zetia failed to show a benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in patients with an inherited form of high cholesterol. In other words, Vytorin may not be of much use as a first or second-line therapy, a fact underscored by several prominent docs when the complete Enhance data was dissected at the American College of Cardiolo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1340924 Mon, 31 Mar 2008 23:09:57 +0100 1340924 http://www.medworm.com/index.php?rid=1338213&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F261223749%2F A bit of good news, actually, at least for the drugmaker. The trial was halted because the cholesterol pill outperformed a placebo in a study to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk. In a statement, AstraZeneca says the independent monitoring board for its Jupiter study met over the weekend and decided there was “unequivocal evidence” of a reduction in cardiovascular morbidity and mortality among patients on Crestor in the study. This is, of course, a boost for the drugmaker, because Crestor its one of its biggest sellers, and the news contrasts sharply with the growing doubts o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1338213 Mon, 31 Mar 2008 11:22:22 +0100 1338213 http://www.medworm.com/index.php?rid=1337084&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F260861609%2F This dispatch was filed by Mark Zucker, a cardiologist and Our Man at the ACC: The Enhance study took center-stage today as four panel members - Drs. Joseph Messer, Patrick O’Gara, Harlan Krumholtz and Rick Nishimura - reviewed the data in which 342 patients were randomized to monotherapy and available for analysis and 328 randomized to combination therapy. Findings: No difference in carotid intimal thickness was seen in the aggregate or in any subgroup, whatsoever. No safety concerns were noted. Proposed explanations for the lack of a difference between the monotherapy and combination therapy cohorts could be that the technique was not sufficiently sensitive; the compound failed to work; or the population was at too low risk. All of these possibilities were considered. Unfortunately... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1337084 Sun, 30 Mar 2008 20:41:12 +0100 1337084 http://www.medworm.com/index.php?rid=1334568&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F259910640%2F No, this isn’t the trial to be revealed and dissected at the American College of Cardiology conference in Chicago this weekend. That study, called Enhance, was already completed - and caused a huge ruckus (back story). But Schering-Plough and Merck, which jointly market Vytorin, hope to prove that a larger study dubbed Improve-It will show their cholesterol pill can outperform Zocor in preventing deaths, heart attacks and strokes. Initially, the trial - which enrolled its first patient in 2005 - was to have examined approximately 10,000 patients, but is being expanded to include about 18,000 patients in order to have a large enough sample size to measure risk, according to a statement by Eugene Braunwald of Brigham and Women’s Hospital, who is chairing the trial. As a result, t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1334568 Fri, 28 Mar 2008 22:54:36 +0100 1334568 http://www.medworm.com/index.php?rid=1332723&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F259612000%2F That’s what one Wall Street analyst posits this morning in an investor note. As you may know, the complete Enhance trial - that controversial study of Vytorin - will be unveiled and dissected at the American College of Cardiology conference on Sunday. The lead investigator, John Kastelein, will make his first public remarks since the release of preliminary data in January engulfed Schering-Plough and Merck in controversy and embarassment. The results found that the cholesterol pill failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL. A debate then ensued about the merits of using Vyotrin, which includes Schering-Plough’s Zetia and Merck’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1332723 Fri, 28 Mar 2008 12:34:06 +0100 1332723 http://www.medworm.com/index.php?rid=1325485&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257588973%2F Last year, the Merck ceo could do no wrong - successful new products were launched and a big chunk of Vioxx litigation was settled. Employee morale and Merck stock were both up. Of course, what a difference a few months can make, especially on Wall Street. Merck shares were below $35 when Dick succeeded Ray Gilmartin in May 2005, and rose to $60.77 in December. But in January, the controversial Enhance results about Vytorin were unveiled and the stock plummeted. Scrips may have since stabilized, but the stock reached a 52-week low of $40.97 on March 14, The Wall Street Journal points out. “I am frustrated,” the low-key ceo tells the paper. “I tell employees, ‘You must be frustrated by what happened in the short term, but be determined to deliver on our 2010 objecti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1325485 Tue, 25 Mar 2008 11:04:04 +0100 1325485 http://www.medworm.com/index.php?rid=1322426&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F256988987%2F As the American College of Cardiology meeting nears this coming weekend in Chicago, the curtain raisers have begun to appear. Last week, Forbes set the stage by discussing why the full study results, which will be presented for the first time, are important. And this morning, The Wall Street Journal does a look back on how the controversial Enhance trial became controversial. As the paper recounts, the Enhance trial found Vytorin was no better at fighting heart disease than Zocor, but doctors and public officials questioned whether Merck and Schering-Plough delayed results for more than a year to protect billion of dollars in sales. The drugmakers, the paper writes, argue they were simply trying to correct irregular data. But by late 2005, company officials overseeing the study already had... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1322426 Mon, 24 Mar 2008 11:01:30 +0100 1322426 http://www.medworm.com/index.php?rid=1316662&cid=t_164011_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F03%2Fmake-way-for-150-second-vytorin-tv-ad.html Schering-Plough CEO Fred Hassan told listeners at a recent Lehman Brothers healthcare conference that Vytorin-Zetia TV ads will soon be back on the air. This time, however, do NOT expect to see the cute food-people comparison ads, which I thought were getting old a long time ago (see "Vytorin Ads Are Getting Old -- and Disturbing!").As I said before:Personally, I don't think there's a snowball's chance in hell that the people-food comparison ads will come back. They are as dead as dodos. SP-Merck will have to come up with new ads like Pfizer did for Celebrex after Vioxx (a similar NSAID) was pulled from the market (see "New Vytorin TV Ads Are in the Works - IMHO").As a matter of fact, my sources (neurons) tell me that the new Vytorin ads will be very similar to the Celebrex 150-second comm... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1316662 Thu, 20 Mar 2008 13:22:00 +0100 1316662 http://www.medworm.com/index.php?rid=1314434&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254336726%2F Here we have a very useful device that can be used to count steps. Of course, Schering-Plough and Merck execs, whose reps were instructed to distribute the item to their docs, may have used it themselves. They could have counted the steps taken to meetings to learn of Enhance results. Or perhaps the number of steps to their cars in the company parking lots, where they held private phone conversations with…their brokers? To stay in shape - and avoid taking Zetia themselves - the pedometer could have kept track as they paced the floors, worrying what to do about congressional investigations. Smartly designed and packaged nicely, the pedometer may even offer the drugmakers entree into the device business - and generate revenue to pay for lost scrips and legal fees. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314434 Wed, 19 Mar 2008 15:13:59 +0100 1314434 http://www.medworm.com/index.php?rid=1300624&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250922725%2F Citing a report in Pharmalot, the Senate Special Committee on Aging wants the drugmaker to hand over documents about its recently launched ‘49 Plan,’ a seven-week schmoozefest in which Schering-Plough reps are being encouraged to wine and dine docs over lunch or dinner. The idea is to remind them that the Zetia cholesterol pill is worth prescribing. The move comes after a big drop in Zetia scrips over the last several weeks. Why the decline? The drugmaker’s controversial Enhance trial found that its Vytorin cholesterol pill failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL. The results created a debate about the merits of using... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1300624 Thu, 13 Mar 2008 18:47:49 +0100 1300624 http://www.medworm.com/index.php?rid=1298179&cid=t_164011_122_f&fid=36582&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FSharpBrains%2F%7E3%2F250263243%2F Quick links to excellent resources: 1) FEATURE-Brain fitness seen as hot industry of the future (Reuters) 2) Learning & the Brain Conference for Educators and Clinicians. April 26-29, 2008. Cambridge, MA 3) Brain Health Across the Lifespan Seminar for Health & Aging Professionals. May 15th, 2008. San Francisco, CA For more info,   1) FEATURE-Brain fitness seen as hot industry of the future (Reuters) Note: Probably the most comprehensive article I have seen so far covering this emerging field, based on our market report and with original reporting. Highly recommended read.  2) Learning & the Brain Conference for Educators and Clinicians - April 26-29, 2008. Cambridge, MA Description: "Cognitive neuroscience has discovered that the brain is not ‘hardwired’ from... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=1298179 Wed, 12 Mar 2008 18:26:50 +0100 1298179 http://www.medworm.com/index.php?rid=1296173&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F249749536%2F How do you solve a problem? Maybe the answer is to throw some money at it. That seems to be the approach Schering-Plough is taking to dealing with the drop in Zetia prescriptions - a 3.8 percent drop in total scrips compared with the same period a year ago and a whopping 17 percent compared with late last year, according to Deutsche Bank analyst Barbara Ryan. Why the decline? You may recall that the controversial Enhance trial found that its Vytorin cholesterol pill failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL. The results created a debate about the merits of using Vyotrin, which includes Schering-Plough’s Zetia and Merck’s Zoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1296173 Tue, 11 Mar 2008 21:43:56 +0100 1296173 http://www.medworm.com/index.php?rid=1245272&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F238145741%2F A new survey of 150 internists, general practitioners and cardiologists finds that all three groups expect to prescribe the cholesterol pill less often as a first-line treatment or even as a second-line treatment. Among general practitions, the use of Vytorin is expected to drop by 20 percent as a first-line treatment; a drop of 9 percent among cardiologists and 7 percent among internists. Meanwhile, usage as a second-line medication is expected to drop across all specialties by 8 to 14 percent of patients. In third-line treatment, however, Vytorin prescriptions received a boost from 20 to 30 percent, according to GfK Market Measures. Moreover, general practitioners say they will switch more than 40 percent of their patients currently on Vytorin or Zetia to other therapies over the next fe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1245272 Wed, 20 Feb 2008 12:34:35 +0100 1245272 http://www.medworm.com/index.php?rid=1239264&cid=t_164011_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F02%2Fpharma-r-succumbs-to-dark-side.html I once said "God bless the dedicated researchers and scientists of the pharmaceutical industry! They are truly the unsung heroes of the pharmaceutical industry! Too bad they are sequestered in their labs!" and "If God blesses the folks in pharma R&D, the devil may take pharmaceutical marketers -- unless they reform!"(see "God Bless R&D, but Marketers May Go to Hell!").I even came up with a nice visual image of this sentiment:Of course, I held little hope that Pharma Marketing would reform, but I didn't think that R&D would make a pact with the devil! The more I learn about about Merck's and Schering-Plough's failed ENHANCE study (see, for example, "How high hopes ultimately hurt Vytorin study"), the more I think a deal indeed was made.Perhaps the following image is better suite... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1239264 Mon, 18 Feb 2008 16:11:00 +0100 1239264 http://www.medworm.com/index.php?rid=1237092&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F236093912%2F A few day ago, Schering-Plough ceo Fred Hassan appeared on CNBC’s Mad Money, where he spoke with Jim Cramer, the hyperactive host, about the controversy surrounding Vytorin. In particular, Cramer asked questions about the famous Enhance trial, which found the cholesterol pill wasn’t any better at reducing arterial plague in the carotid artery compared with Zocor, and even found a statistically insignificant buildup. Congress is investigating, you may recall, whether Schering-Plough and Merck, its marketing partner, handled the release of the clinical-trial data properly, given a two-year delay; a brief change in the primary endpoint without consulting the lead investigator, and huge stock sales by some Schering-Plough execs. In its defense, Schering-Plough issued an unusual tim... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1237092 Sat, 16 Feb 2008 14:21:51 +0100 1237092 http://www.medworm.com/index.php?rid=1226842&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234159857%2F The website where detailers love to dish last night posted a message of its own telling the House Energy & Commerce Committee ‘thanks, but no thanks.’ You may recall that, earlier this week, the committee widened its probe yet again into the way Merck and Schering-Plough handled the controversial Enhance trial of their Vytorin cholesterol pill and, as part of their investigation, sought info on some intriguing threads that showed up several months ago on CafePharma. Those threads, which you can look at here, appeared to contain remarkably similar info to what eventually became known months later. Like nearly every post on CafePharma, however, the threads are entirely anonymous. So the commmittee wrote the site and asked for names, addresses, phone numbers, and e-mail and I... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1226842 Wed, 13 Feb 2008 05:31:56 +0100 1226842 http://www.medworm.com/index.php?rid=1225628&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F233914720%2F In his carefully rehearsed remarks this morning, the Schering-Plough ceo tried to strike an aggressive tone with the plethora of analysts, fund managers and media listening to the teleconference call. All ears were attuned, of course, to any nuances or shadings that Fred and his lieutenants might provide on the controversial Enhance trial, which found that Vytorin failed to yield any statistical advantage over the cheaper Zocor in reducing arterial plaque. The issue, as you may recall, is whether the drugmaker and its joint venture partner, Merck, handled the release of clinical trial data properly, given that the lead investigator wasn’t consulted when the endpoint was briefly changed; the results were delayed nearly two years and several Schering-Plough execs sold huge chunks of st... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1225628 Tue, 12 Feb 2008 19:23:14 +0100 1225628 http://www.medworm.com/index.php?rid=1225295&cid=t_164011_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F02%2Fsocial-media-to-congress-piss-off.html I love a Congressional investigation as well as the next guy, especially when it involves purported wrong-doing by pharmaceutical company bigwigs.The House Committee on Commerce investigation into "who knew what when" about the ENHANCE clinical trial is a case in point. Did bigwigs at Schering-Plough cash in stock options well ahead of the negative news?As pointed out by whistleblower Peter Rost on BrandweekNRx, at least a few people inside SP knew that ENHANCE was a failure way back in March, 2007 -- about 10 months prior to the public announcement and a month or two before Schering bigwigs -- including president Carrie Cox -- sold stock (see "New evidence indicates Schering-Plough insiders knew the Vytorin trial was "a bust" on March 13, 2007").These people inside SP were "anonymous" pos... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1225295 Tue, 12 Feb 2008 12:10:00 +0100 1225295 http://www.medworm.com/index.php?rid=1223812&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F233430131%2F As early as last spring, there was scuttlebutt about the controversial Vytorin data - the bet-the-franchise study that failed to find any statistical advantage over the much cheaper Zocor in reducing arterial plaque. The results were delayed for nearly two years while the primary endpoint was briefly changed by Merck and Schering-Plough without consulting the lead investigator. Meanwhile, Vytorin and Zetia (which, along with Zocor comprise the Vytorin combo therapy) were heavily promoted. And concerns that Schering-Plough execs sold lots of stock last year have sparked investigations by Congress and two state attorneys general. This has all led to the ‘Who knew what and when?’ line of skepticism toward Schering-Plough and Merck, its Vytorin joint venture partner. The drugmakers have re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1223812 Tue, 12 Feb 2008 06:21:30 +0100 1223812 http://www.medworm.com/index.php?rid=1219525&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231854198%2F The drugmaker has announced a few organizational changes at its research operations and, while the recent acquistion of Organon Biosciences is cited as a prime reason, the moves come after weeks of mounting criticism over the handling of the Enhance trial for the Vytorin cholesterol med. First up is Jacqueline Elbonne, an eight-year Schering-Plough veteran, who is now a vp for global research quality, which means she will oversee the interplay between research and such activities as manufacturing, labs, clinical work and pharmacovigilance, while also meeting regulatory requirements. She now reports to Tom Koestler, executive vp and the president of the drugmaker’s research unit. No specific explanation is offered for the move. The Organon deal, however, is cited as the reason for the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1219525 Fri, 08 Feb 2008 21:39:56 +0100 1219525 http://www.medworm.com/index.php?rid=1186081&cid=t_164011_147_f&fid=35750&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FHealthCareVox%2F%7E3%2F225471131%2Fthe_role_of_surrogate_markers.html Cholesterol-lowering therapy sure has been taking a beating lately.  For many years, it was accepted that cholesterol medications are good because they reduce “bad” LDL cholesterol.  Over time, lowering LDL would lead to fewer heart attacks and strokes, which is a good thing.  However, recently some have been preaching against this gospel.  The premise of a widely-cited BusinessWeek article was that statins do little for people without pre-existing heart disease.  In addition, we have the furor over the ENHANCE trial. Overall, the study failed to show that the combination drug Vytorin had any influence on the build up of fatty plaques in the arteries.  Arterial plaque is a major (and physical) indication that a person is at risk for a heart attack ... HealthCareVox blogs http://www.medworm.com/rss/comments.php?id=1186081 Tue, 29 Jan 2008 21:06:38 +0100 1186081 http://www.medworm.com/index.php?rid=1182991&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F224548942%2F In their ongoing effort to defend themselves from accusations of insider trading and improper marketing, the drugmaker has filed a document with the Securities and Exchange Commission offering more precise info about when they were informed of the Vytorin study results. Tom Koestler, chief scientist: Jan. 7 at 2 p.m. Fred Hassan, ceo: Jan. 10 at 8 a.m. Tom Sabatino, general counsel: Jan. 10 at 8 a.m. Carrie Smith Cox, exec vp and president: Jan. 10 at 8:30 a.m. Bob Bertolini, exec vp: Jan. 10 at 9 a.m. The study results were issued in a press release on Jan. 14, although that came after a delay of nearly two years with scant info from either Schering-Plough or Merck, its joint-venture partner. By then, however, the drugmakers endured two months of withering criticism for briefly changing ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1182991 Mon, 28 Jan 2008 12:54:59 +0100 1182991 http://www.medworm.com/index.php?rid=1179972&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F223675513%2F (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1179972 Sun, 27 Jan 2008 08:44:07 +0100 1179972 http://www.medworm.com/index.php?rid=1173164&cid=t_164011_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F01%2Fnew-vytorin-tv-ads-are-in-works-imho.html According to an AP report, Merck & Co. and Schering-Plough Corp. have suspended TV ads for Vytorin a week after a study revealed the cholesterol drug is "no more effective than a high dose of one of its components available generically at a third of the cost."They made this decision, said Skip Irvine, a spokesman for Merck/Schering-Plough, "in light of mischaracterization and misinterpretation of the enhanced (sic) trial results."There's just a few observations about this decision that I'd like to make before I discuss why I believe that NEW Vytorin TV ads are in the works.Observation # 1: It's ENHANCE, Skip, not ENHANCED! Is that a misquote Skip, or are you trying to put some subliminal spin on it? If you can't even get the name of the trial right, why should I swallow your "mischarac... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1173164 Wed, 23 Jan 2008 12:17:00 +0100 1173164 http://www.medworm.com/index.php?rid=1161236&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F218945175%2F Fred knows a good deal when he sees one. The reaction to the controversy over the Vytorin trial has gotten so bad that Schering-Plough stock is down roughly 20 percent this week. What better time to buy? And so Fred is wading in to snap up $2 million in stock with his own money. “As was the case in November 2003, when I purchased $4.68 million in Schering-Plough common shares at an average price of $15.42, this investment in Schering-Plough reflects my long-term confidence in the company, its products (including Zetia and Vytorin), and our late-stage pipeline,” he says in a statement, in which he blames the media portrayal of the trial results, but ignores the lack of transparency surrounding the release and handling of the data - a nearly two-year delay in disclosing results,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1161236 Fri, 18 Jan 2008 15:46:15 +0100 1161236 http://www.medworm.com/index.php?rid=1158443&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F218366134%2F The Enhance trial continues to reverberate. Investors are again pummeling Schering-Plough stock. Docs are scurrying to calm patients worried about whether they should continue taking Vytorin (or Zetia, which is part of the combo therapy), and Congress is pressing ahead with an investigation into how Merck and Schering-Plough execs ran the clinical trial, advertised the drug and sold their own shares. The controversy is undermining what, until now, has been Hassan’s successful turnaround of Schering-Plough, which hoped the trial would show Vytorin to be a more effective cholesterol treatment than Merck’s Zocor, the other half of the Vytorin combination. The trial, of course, failed its primary endpoint, but Fred is trying to take it all in stride. “Things happen with the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1158443 Thu, 17 Jan 2008 17:49:32 +0100 1158443 http://www.medworm.com/index.php?rid=1156041&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F217811422%2F As part of its investigation into why Merck and Schering-Plough held onto the Vytorin trial data for two years and briefly changed the primary endpoint before the disappointing results were finally released this week, the House Subcommittee on Oversight and Investigations now plans to also look at the possibility that any of the drugmakers’ execs engaged in insider trading. A subcommittee spokesman tells us that letters are due to be sent to Merck and Schering-Plough today or tomorrow, following comments made this morning on CBS’s Early Show by subcommittee chair Bart Stupak, a Democrat from Michigan. “There’s certainly major misrepresentations not only to the effectiveness of the drug, but manipulating of the scientific data to further promote a product that isn&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1156041 Wed, 16 Jan 2008 19:47:40 +0100 1156041 http://www.medworm.com/index.php?rid=1154084&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F217340015%2F The controversial Vytorin trial released by Merck and Schering-Plough yesterday was quickly interpreted by Cleveland Clinic cardiology star Steve Nissen (pictured left) as a reason to use the drug as a last resort (he said the same thing about Zetia, which along with Zocor, is contained in Vytorin). His remarks apparently contributed to a sell-off in Merck and Schering-Plough stock, prompting Wall Street wags to call his reaction an overreaction. This evening, the American College of Cardiology released a statement saying the same thing - prescribers and patients should think twice before switching off either med. This is a slap in the face for Nissen, who stirred controversy last year with his meta-analysis of Glaxo’s Avandia diabetes pill. Moreover, “this is a major win for S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1154084 Wed, 16 Jan 2008 00:49:57 +0100 1154084 http://www.medworm.com/index.php?rid=1152509&cid=t_164011_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F01%2Fshould-i-stop-taking-zetia.html After Merck & Co. and Schering-Plough Corp. admitted that Vytorin -- a combination of Zetia and Zocor (simvastatin) -- worked no better than an older, generic medication to reduce plaques in arteries, Dr. Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, immediately called for a "moratorium" on the use of Vytorin and Zetia, according to a story on Bloomberg.com (see coverage here).My question is this: Should I stop taking Zetia, which was prescribed to me by my cardiologist, who--although I respect his judgment--is no head of cardiology at a renowned medical center?The problem is that I haven't heard from MY CARDIOLOGIST or MY FAMILY DOCTOR about whether or not I should continue to take Zetia. I guess I should call them.But why is it that the my Volkswagen service cent... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1152509 Tue, 15 Jan 2008 12:03:00 +0100 1152509 http://www.medworm.com/index.php?rid=1149827&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216673771%2F Just because Merck and Schering-Plough finally released the dismal results of the Enhance trial for their Vytorin cholesterol med doesn’t mean John Dingell and Burt Stupak are done looking into the two-year delay in disclosing the data or the reasons for, briefly, changing the primary endpoint. Au contraire. The congressmen, who announced their probe the same day Merck and Schering-Plough backpedaled on the primary endpoint, released a statement this afternoon saying the House Energy and Commerce Committee are as energized as ever about learning the reasons the drugmakers behaved as they did. “Today’s announcement that the Enhance study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1149827 Mon, 14 Jan 2008 22:29:44 +0100 1149827 http://www.medworm.com/index.php?rid=1146755&cid=t_164011_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F215203642%2F Earlier today, we noted that Forbes named the presumably independent panel of experts retained by Merck and Schering-Plough to help them assess the results of their long-overdue Enhance study of Vytorin, the cholesterol med that was being compared with Zocor. At first, the drugmakers refused to disclose the panel members, compounding the scandal that ensued after it became known the endpoint for the trial was changed in midstream. And this change was made, by the way, without the knowledge of the lead investigator. Now, Roy Poses at Health Care Renewal has played our favorite game - connect the dots. Using PubMed, he found a few interesting tidbits about the independent panel members. To wit, three have ties to Merck and Schering-Plough… J. Robin Crouse - grant or salary support from... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1146755 Fri, 11 Jan 2008 22:15:33 +0100 1146755 http://www.medworm.com/index.php?rid=483532&cid=t_164011_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F03%2F20%2Ftai-chi-for-diabetes%2F Filed under: Type 1, Type 2, Childhood, Adult Onset, Lifestyle, Exercise, Books, ProductsTai Chi for Diabetes is easy to learn, effective and safe. It is designed to prevent and improve control of diabetes. The program will help to improve muscle strength, increase heart and lung activity, as well as improve balance and harmonize mind and body. Gentle exercise helps people with diabetes by improving the control of blood glucose level. Tai chi is a gentle exercise with strong emphasis on mental relaxation, it is reasonable to assume tai chi can help to control diabetes by improving cellular uptake and glucose metabolism. Tai chi can also help mitigate the effects of stress, which is shown to make the control of diabetes worse. Tai chi reduces stress and improves relaxation. The major proble... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=483532 Tue, 20 Mar 2007 04:00:00 +0100 483532