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 'amp'. Sat, 03 Sep 2011 01:51:57 +0100 http://www.medworm.com/index.php?rid=5174864&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb0mlnNwQLrQ%2F Over the weekend, Pfizer and Bristol-Myers Squibb released complete results of a Phase III trial for their forthcoming bloodthinner and, as expected, the findings clearly suggest the drugmakers have a treatment that will surpass rival meds. Why? Eliquis prevented more strokes with less major bleeding than warfain, the decades-old standard treatment in patients with atrial fibrillation, and also reduced the number of deaths. Consequently, the outcome underscores that one of the next, big marketing battles in the pharmaceutical industry will unfold after the drugmakers secure FDA approval, a step that is not expected until 2012. Already, Boehringer Ingelheim is marketing Pradaxa and Johnson & Johnson and Bayer expect to launch their Xarelto treatment later this year. Xarelto, by the way... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5174864 Mon, 29 Aug 2011 13:47:47 +0100 5174864 http://www.medworm.com/index.php?rid=5174865&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSbGm4lXB2Kw%2F Welcome back. This was a long weekend thanks to the hurricane that swept past the Pharmalot corporate campus and inundated the surrounding region. We are slowly returning to our usual form and reviving our spirits with a needed cup of stimulation. We hope those of you who suffered the storm are doing well. As the Morning Mayor used to say: Every brand new day should be unwrapped like a precious gift. Meanwhile, as we get into gear, here are a few items that should be of interest… Roche Sees Government Austerity Bolstering Diagnostics Unit (Bloomberg News) FDA Asks Novartis For More Data On Gout Drug (Reuters) Pfizer Wins FDA Approval For Targeted Lung Cancer Med (Bloomberg News) India’s Piramal Wants To Buy Ailing Biotechs (Financial Times) More Than Half Of CRO Sales Are Made ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5174865 Mon, 29 Aug 2011 12:25:42 +0100 5174865 http://www.medworm.com/index.php?rid=5159833&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSUw2xkpf29g%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Astellas US named Percival Barretto-Ko as senior vp of corporate strategy and government affairs. Before that, he was executive director, corporate strategy and communications at Astellas Pharma Europe. Prior to joining Astellas, he held senior... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159833 Fri, 26 Aug 2011 12:11:26 +0100 5159833 http://www.medworm.com/index.php?rid=5159834&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOa5-_YVQ_fM%2F And so another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes shuttling one of our short people off to an institution of higher learning, catching up on some reading and then bracing for a hurricane. Big fun, as they say. And what about you? Will you be boarding windows? Evacuating the homestead? For those of you in other locales, perhaps this slow time of the year is ripe for a pleasant drive or an outdoor event. Whatever you do, enjoy and be safe. See you soon… UK Probes How Medications Were Switched (BBC) Cipla Seeks Partners, Not Divestitures (Pharma Times) Shire Wins Approval Of Anti-Swelling Drug (Bloomberg News) Surgical Mesh Devices Should Be Banned: Watchdog Group (Star-Ledger of NJ) FDA Ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159834 Fri, 26 Aug 2011 12:09:55 +0100 5159834 http://www.medworm.com/index.php?rid=5159196&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F26%2Fbest-of-our-blogs-august-26-2011%2F I sometimes wonder if our focus on “doing things right” is what causes us more pain, anguish and difficulty than anything else in life. It’s almost as if those red marks on our graded assignments as kids stay with us when we become adults. In fact, our fear of impending negative feedback often grows as we grow older. We hold our vulnerabilities even closer, wrapping them up carefully like we would a glass vase or a precious piece of china. We’re fearful of sharing our feelings. We hold back our laughter, forgetting that as kids we let it all out from our bellies to our mouths. And to shield our pain, instead of crying, confronting or expressing ourselves, we avoid loved ones when they’ve hurt us. Yet, in order to fully live, to feel completely alive, we must f... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159196 Fri, 26 Aug 2011 10:36:56 +0100 5159196 http://www.medworm.com/index.php?rid=5159836&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAhQvJIfu6qE%2F Concerns about conflicts of interests are all the rage these days. The FDA is debating whether to loosen rules over complaints that an insufficient number of experts are available for its advisory committees. And the National Institutes of Health just issued new rules covering academics who receive federal funding for their research and also have ties to industry (see here and here). As it turns out, the US Department of Health & Human Services, which oversees both agencies, has its own problems with conflicts. A new report by the HHS Office of Inspector General found most conflict-of-interest waivers issued two years ago were not documented as recommended in federal ethics regulations and only a minority of waivers were signed and dated by HHS employees receiving them. These waivers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159836 Thu, 25 Aug 2011 15:12:11 +0100 5159836 http://www.medworm.com/index.php?rid=5159199&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F25%2Fto-heal-after-an-affair-and-rebuild-the-relationship%2F “For many people, an affair is deeply traumatizing [and] some marriages can’t recover from it,” said Jason Seidel, PsyD, founder and director of The Colorado Center for Clinical Excellence in Denver. But if you decide to work on your relationship post-affair, you must accept a hard truth: Another affair can happen. This is the paradox of healing, Seidel said. Often, partners who’ve been cheated on will demand full access to their spouse’s email, cell phone records, Facebook and other accounts (or they’ll sneak around to get the access), he said. They see this as legitimate and essential to helping reestablish trust in the relationship. A common belief is “How could I ever trust you again unless you give me full access?” While this thinking is understandable, it simply doesn... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159199 Thu, 25 Aug 2011 12:40:21 +0100 5159199 http://www.medworm.com/index.php?rid=5159203&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F23%2Fbest-of-our-blogs-august-23-2011%2F Every once in awhile, I like to snoop around my old diaries. Besides personally being one of the best non-fiction reads to me, it gives good insight into who I was and potentially who I will be. One of the jewels of wisdom I recently picked up from a 7 year old Winnie the Pooh journal contained information on my state of mind at the time. The details are not important. But the general feeling of that entire year was one of heartache and confusion. There was this sense of longing, emptiness, a feeling that whatever I was going through was not only uncomfortable, but unfair. I even wrote: “When I’m 50, I’ll probably look back on this moment and it will be a fleeting and insignificant memory. But right now, I’m having a hard time with it.” I smiled reading it bec... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159203 Tue, 23 Aug 2011 11:39:33 +0100 5159203 http://www.medworm.com/index.php?rid=5159205&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F22%2Fthe-myth-of-the-one-and-other-relationship-fantasies%2F Psychologist Jason Seidel, Psy.D, has heard partners lament all-too often: “This isn’t the person I married” or “I’m worried this person isn’t perfect for me.” And you know what? They’re probably right. But there’s more to relationships than a partner who remains the perfect fit your entire life. Seidel explains more about the myth of the perfect partner and other relationship fantasies. 1. Myth: Your partner will always be the one. Fact: There is no “once-and-for-all best match,” said Seidel, founder and director of The Colorado Center for Clinical Excellence in Denver. People and relationships rarely remain static. So that once great fit may “become broken, stale or wrong for [you].” In fact, according to Seidel, as you continue to grow in your life, you might ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159205 Mon, 22 Aug 2011 10:47:51 +0100 5159205 http://www.medworm.com/index.php?rid=5130817&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F14%2F2-must-try-mindfulness-practices%2F “Just as an untamed elephant can do damage, trampling crops and injuring people, so the untamed, capricious mind can cause harm to us and those around us.” So writes Jan Chozen Bays, M.D., a physician and Zen teacher, in her book How to Train a Wild Elephant & Other Adventures in Mindfulness: Simple Daily Mindfulness Practices for Living Life More Fully & Joyfully. How often have you let negative thoughts run your life? Let a punitive perspective take over so you end up beating yourself up for the smallest of supposed offenses? Or just experienced the days like you’re listing through a boring book, going through the motions but skimming the significant stuff? Something that can help is mindfulness. According to Chozen Bays, “Mindfulness unifies our body, heart and mind, br... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5130817 Sun, 14 Aug 2011 11:02:49 +0100 5130817 http://www.medworm.com/index.php?rid=5125967&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLSYf4qbxl5I%2F In another instance in which a drugmaker appears to have bribed overseas officials, Pfizer has “voluntarily” provided the US Department of Justice and the US Securities and Exchange Commission with information concerning “potentially improper payments” made by Pfizer and Wyeth personnel in connection with certain unspecified sales activities outside the US. The move comes amid increased scrutiny by the feds into the pharmaceutical industry and its interactions with foreign health care systems. In late 2009, the head of the Justice Department’s Criminal Division warned drugmakers that there will be more criminal enforcement against interactions with foreign officials as they seek violations of the Foreign Corrupt Practices Act (see here). In April, Johnson & J... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5125967 Fri, 12 Aug 2011 12:36:53 +0100 5125967 http://www.medworm.com/index.php?rid=5118993&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fro-VnpB2yDg%2F If numbers tell a story, then Bayer and Johnson & Johnson may have some explaining to do. The complete results of a widely anticipated study known as Rocket were just published and show their Xarelto bloodthinner is not only just as safe as warfarin - the standard treatment - but 21 percent better at preventing stroke in patients with atrial fibrillation. But there was more, and it was sobering. An editorial in the same issue of The New England Journal of Medicine maintains the use of multiple statistical analyses to assess the medication “muddied the waters” when it comes to fully understanding efficacy and effectiveness compared with warfarin. The point raised by Gregory Zoppo of the University of Washington, and Misha Eliasziw of the University of Calgary may prompt cl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118993 Thu, 11 Aug 2011 13:11:12 +0100 5118993 http://www.medworm.com/index.php?rid=5118994&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FX-4k_OX50Ks%2F Top of the morning to you. And what a morning it is. A lovely sun is shining overhead and a cool breeze is wafting through the Pharmalot corporate campus. This calls for a celebratory cup of stimulation. Nonetheless, meetings and deadlines loom. So let us all get started. A few interesting items can be found below. Meanwhile, if you hear of anything interesting, drop us a line. Have a great day, everyone… FDA OKs Gilead And J&J Once-Daily HIV Pill (Reuters) Pfizer Pays First Compensation To Nigerian Trovan Victims (BBC) Vioxx Lawyers Get More Fees After Filing Objections (Bloomberg News) Pfizer To Shed 130 Jobs And Close Former King Plant (TriCities) FDA Sets Review Deadline For Amylin Diabetes Drug (Reuters) FDA Questions Adventrx Trial Run By CRO In Argentina (Outsourcing Phar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118994 Thu, 11 Aug 2011 11:53:50 +0100 5118994 http://www.medworm.com/index.php?rid=5118999&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXfrSl4-LlPM%2F WE ARE REPEATING THIS ITEM FROM LAST NIGHT WHEN IT FIRST BROKE…As Johnson & Johnson attempts to resolve a raft of litigation and government investigations related to Risperdal marketing, attorney generals from approximately 40 states are deciding whether to pile on as they pursue a coordinated civil investigation into potential consumer fraud violations, according to a filing with the Securities and Exchange Commission. In order to make their case, the states and J&J reached a so-called tolling agreement, which essentially delays the expiration of a statute of limitation for filing a lawsuit. The disclosure was made in a J&J filing with the US Securites and Exchange Commission (see page 32). The move is the latest indication J&J is working toward a global settleme... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118999 Wed, 10 Aug 2011 11:57:24 +0100 5118999 http://www.medworm.com/index.php?rid=5107598&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F09%2Fadhd-and-marriage-boundaries-can-help-rebuild-your-relationship%2F In marriages where one spouse has attention deficit hyperactivity disorder (or both do), there are often many challenges. One of them is overstepping each other’s boundaries. For instance, a partner with attention deficit hyperactivity disorder (ADHD) might assume without asking their partner that they’ll just take over all the household responsibilities, including chores and finances, or they might refuse to treat their symptoms and give the ultimatum to “take it or leave it.” A non-ADHD spouse might take over all the responsibilities because they think their partner is incompetent or they might try to change them altogether. In her book, The ADHD Effect on Marriage: Understand and Rebuild Your Relationship in Six Steps, marriage consultant Melissa Orlov (who I recently interviewe... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5107598 Tue, 09 Aug 2011 15:45:34 +0100 5107598 http://www.medworm.com/index.php?rid=5107893&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXpncqmok5No%2F Rise and shine. Another day is on the way. And it looks to be a sunny one here on the Pharmalot corporate campus, where we are brewing a delicious cup of mandatory stimulation. Our flavor today is Southern Pecan. Please join us. After all, there is much to do as meetings and deadlines beckon. You know the score, so time to dig in. Meanwhile, here are some tidbits. Have a great day and let us know if you hear of something interesting… FDA Approval Of Roche Melanoma Drug May Come Early (Reuters) Pfizer Sends Israeli Sniffing Dogs To Finland (The Jerusalem Post) Revlimid Side Effects Linked To Protein In Study (Reuters) Valeant Pharma Eyes Medicis For Another Acquisition (Pharma Times) Merck And J&J Sit On Piles Of Cash (The Star-Ledger of New Jersey) Lexicon Tumor Drug Shows Posit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107893 Tue, 09 Aug 2011 12:06:27 +0100 5107893 http://www.medworm.com/index.php?rid=5107898&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjT4ncXm_IJU%2F The group of drugs known as ESAs are apparently being used inappropriately in cancer patients, suggesting that the expensive treatments are being wasted and exposing patients unnecessarily to serious side effects, according to a new study in the Journal of Clinical Oncology. Specifically, the meds were administered for no more than one week in 24 percent of patients, which is an insufficient amount of time to offer a useful benefit, according to the researchers (read the abstract). Moreover, nearly eight percent of the patients received one of the drugs for more than 14 weeks, while almost 14 percent were getting the drugs when they weren’t on chemotherapy.” The meds are approved for cancer patients who are getting chemotherapy, and recommended treatment is between two and 14 w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107898 Mon, 08 Aug 2011 12:55:04 +0100 5107898 http://www.medworm.com/index.php?rid=5096339&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F05%2Fbest-of-our-blogs-august-5-2011%2F You could be doing everything right: seeking therapy, taking medication, living a healthy life. But then someone or something triggers you and your world is thrown upside down. For me, it’s surrounding myself with people and situations from the past. I can conveniently “forget” who I am is not who I was. On many levels, this could be destructive. It’s forgetting that I am an adult when I am with my family or that I am now allergic to seafood when I was not as a child. I know these seem like minor incidences, but put me in a situation like that for a continuous period of time and I begin to lose myself. For you, it could be believing that you are suddenly immune to outside negative influences-that you can spend the entire summer season with a negative relative or fri... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5096339 Fri, 05 Aug 2011 11:41:43 +0100 5096339 http://www.medworm.com/index.php?rid=5086555&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5c_0SbNM9XU%2F Yet another state has filed a lawsuit alleging that Johnson & Johnson illegally marketed its Risperdal antipsychotic to the detriment of its citizens. This time, Massachusetts alleges J&J promoted the drug to treat elderly dementia and various unapproved uses in children and adolescents. The state also claims J&J failed to disclose serious risks such as the possibility of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death. “Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Massachusetts Attorney General Coakley says in a statement. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086555 Mon, 01 Aug 2011 22:40:47 +0100 5086555 http://www.medworm.com/index.php?rid=5086560&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfEJZC4F4xVU%2F Good morning, everyone. Hope you had a nice weekend. Now, of course, the routine resumes, although this is often a slow time of year. Nonetheless, there is much to be done here in the official Pharmalot c-suite, where we are catching up on interesting documents and conversations. And of course, we are brewing that mandatory cup of stimulation and invite you to join us. Meanwhile, here are a few tidbits from around the world. Hope your day goes well and you accomplish much… Teva’s Copaxone Successor Fails In Latest Clinical Trial (Bloomberg News) Pfizer Says FDA Delays Prevnar Review For Three Months (Bloomberg News) Cuba Sentences Pharma Execs For Corruption (Associated Press) Japan’s Shionogi Acquires C&O Pharmaceutical Tech (ChannelNewsAsia) New FDA Commish Asks Co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086560 Mon, 01 Aug 2011 12:00:25 +0100 5086560 http://www.medworm.com/index.php?rid=5078030&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNevGtGupvz8%2F It is no secret that managing a biotech these days is trickier than ever. To cope, many have cutback on R&D spending and hoarding cash, even as revenues are rising, according to a new analysis. Overall, biotechs spent $54 million on R&D in 2010, which is down 7 percent from the previous year. This followed a 9 percent decline in spending in 2009. The good news is that average revenues rose 11 percent to $77 million, up from $69 million in 2009. The overall increase in revenue has been spurred by strategic partnerships with large pharmaceutical companies. Small biotechs with less than $50 million in revenues reported a 42 percent increase, but larger biotechs reported average revenue of $124 million, a 3 percent decline from last year. “Biotech companies saw a double-digit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078030 Fri, 29 Jul 2011 13:55:32 +0100 5078030 http://www.medworm.com/index.php?rid=5069822&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8WFD_ZbuCB4%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding on the Pharmalot corporate campus, where we have much to do. You know, the drill - reading documents, making phone calls, finding interesting tidbits. To prepare, yes, we are downing that mandatory cup of stimulation - our flavor today is Wild Mountain Blueberry. So please join us. Meanwhile, here are some items from around the world. Hope your day goes well and stay in touch… Pfizer’s Zyvox and Antidepressants May Cause Fatal Reaction (Bloomberg News) Valeant Approaches Swedish Drugmaker Mada About A Takeover (Bloomberg News) Abortion Pill Given Via Telemedicine Is Safe And Effective (Reuters) Vertex Says Hepatitis C Drug Combo Works (Reuters) Naeja Pharmaceutical R&D Facility Catches Fire (Cal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069822 Wed, 27 Jul 2011 11:41:22 +0100 5069822 http://www.medworm.com/index.php?rid=5069533&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F26%2Fbest-of-our-blogs-july-26-2011%2F I call one of my relatives a “bad news bear.” Although he has good intentions, his spewing out the world’s greatest tragedies every few minutes does not help me. In fact, all that worrying and anxiety could hurt. After calling him out on it, he said his main intention was concern. I get that. I think parents today are like him. They just want to protect their children from the onslaught of offenders who are posted up all over the news 24/7. If you love someone, however, how do you best protect them? I think there is a balance between caring and being overprotective. And everyone deals with this in their own way. Some loved ones may minimize your pain because they hurt seeing you upset. That’s why they say things like, “I’m sure you’ll feel better s... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5069533 Tue, 26 Jul 2011 11:02:25 +0100 5069533 http://www.medworm.com/index.php?rid=5062497&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeTMnwRl80K0%2F Last month, a federal court ruled that a drug or device maker remains liable under the False Claims Act even when a pharmacy or hospital was unaware that a kickback was made to a doctor to induce the sale of a product for which reimbursement was sought from Medicare and Medicaid. The decision was seen as a game changer, because dismissing whistleblower lawsuits would likely become more difficult. Until then, courts had ruled the False Claims Act could not have been violated if a pharmacy does not know that a prescription was only written because a drugmaker gave a kickback to a doctor. Whistleblowers have argued, however, that a violation occurs once reimbursement is sought from Medicaid or Medicare. But the US Court of Appeals for the First Circuit disagreed. Not surprisingly, the same co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062497 Mon, 25 Jul 2011 22:24:53 +0100 5062497 http://www.medworm.com/index.php?rid=5062500&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdI34cgVq2EI%2F After two decades during which complaints have mounted over various aspects of clinical trials, the US Department of Health & Human Services has issued a proposal that would, presumably, better protect clinical trial subjects. There are various suggestions, but include improving consent forms for participants and mandating the use of a single institutional review board for multi-study sites. “The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site,” the HHS states in its proposal, which indicates comments can be submitted for 60 days as of July 25 - which is today - according to an HHS spokeswoma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062500 Mon, 25 Jul 2011 14:16:58 +0100 5062500 http://www.medworm.com/index.php?rid=5062501&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBxxWwaHNRcQ%2F Hello, everyone. How was your weekend? We apologize for the delay this morning but the Pharmalot corporate campus was without juice, so we have had to switch to our Red Alert mode. We trust you understand. To cope, we are downing unusually large cups of stimulation. Meanwhile, here are some tidbits. And the usual flow of interesting items will soon appear. Have a great day… Bayer’s Xarelto Bloodthinner Matched Warfarin In Safety Study (Bloomberg News) FDA Rejects J&J’s Simponi For Additional Use (Associated Press) Prescription Drug Prices To Plunge As Patents Expire (Associated Press) Medicis CEO In The Spotlight After Deaths At His Mansion (Los Angeles Times) Express Scripts Deal With Medco Could Pressure Pharma (Dow Jones) Lupin And Medicis Sign R&D Agreement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062501 Mon, 25 Jul 2011 13:48:52 +0100 5062501 http://www.medworm.com/index.php?rid=5051233&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_Ne7ygGc-0w%2F Faced with being banned from doing business with such federal healthcare programs as Medicare and Medicaid, Forest Laboratories ceo and president Howard Solomon recently retained former US Senator John Breaux as a lobbyist. The Louisiana pol is now a senior counsel with the Patton Boggs law firm, which has a large healthcare practice (see here). His lobbying registration form was filed on June 14, two months after the Office of Inspector General of the US Department of Health & Human Services notified the drugmaker that its 83-year-old executive was facing exclusion (read this). The Hill first reported Forest hired Breaux. Last year, Forest pleaded guilty to obstruction of justice and made a $313 million payment that included $164 million in criminal penalties, and signed a corporate ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051233 Fri, 22 Jul 2011 14:48:51 +0100 5051233 http://www.medworm.com/index.php?rid=5051238&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbCFE16uqAmc%2F And so, another working week will soon draw to a close. As you know, this is our welcome signal to daydream about weekend plans. Our agenda is modest - a dip in the pool, an evening of soccer with one of the short people and catching up on some reading. What about you? Given the heat, a few indoor activities may be in order. How about an air-conditioned drive in the country or a movie marathon (if you avoid paying for more than one flick, you have a bargain). You could take a trip to the mall and spur the economy. Or you could stay home and turn on the telly for updates on the debt talks. Whatever you do, have a good time and stay cool. See you soon… Bristol-Myers Buys Amira Pharmaceuticals For Up To $475M (Xconomy) Merck And Simcere Pharmaceutical Form Joint Venture (China Daily) Ex... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051238 Fri, 22 Jul 2011 11:44:20 +0100 5051238 http://www.medworm.com/index.php?rid=5050721&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F18%2Fbed-sharing-seems-okay-for-toddlers%2F While not particularly popular here in the U.S., bed sharing arrangements are a little more common in many other countries, especially when sleeping quarters may be scarce. A new study just published suggests that such bed sharing between parents and their toddlers and young children probably don’t result in any kind of long-term psychological or social problems. The study followed a sample of 944 low-income families who were enrolled in the Early Head Start program, and followed the toddlers and parents over the course of five years. Once other factors were accounted for — such as the family’s socioeconomic status, the mom’s educational level, ethnicity and parenting style — the negative outcomes associated with bed sharing went away. This suggests that bed s... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5050721 Mon, 18 Jul 2011 17:06:36 +0100 5050721 http://www.medworm.com/index.php?rid=5028452&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F14%2Fone-of-the-biggest-barriers-to-creativity-and-how-to-overcome-it%2F Anyone who writes — or creates anything that goes out to the public — knows that oftentimes the product is akin to putting your heart out on a piece of paper (or laptop, or canvas and so on). Vulnerable, scary and vomit-inducing. So even if you get 100 compliments and kind words, one negative remark roars above the rest. It sticks out and stays with you. Not only does it have you questioning your work but, worse, your worth. Or even just the idea of being evaluated gets under your skin. Instead of telling the truth or letting your creativity flow freely, limitless and liberated, you’re paralyzed because you’re thinking about what everyone else will be thinking. So one of the biggest barriers to creativity is, as you’ve probably guessed by now: concern over the critics — be they... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5028452 Thu, 14 Jul 2011 10:15:04 +0100 5028452 http://www.medworm.com/index.php?rid=5028458&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F12%2Fbest-of-our-blogs-july-12-2011%2F I wouldn’t call myself a hoarder. But I have what probably most of us have: an ordinary case of messy-itis. Underneath my bed you would find a collection of old books I’ve been meaning to read and a stack of unread old magazines or two. But after nearly tripping over a glossy mag the other day, I finally decided to face the music and deal with the growing clutter under my bed. The first thing I grabbed was a copy of O magazine’s April issue. ”Not bad,” I thought. Until I saw it was circa 2010. Yikes! Anyway, as I randomly flipped through the issue I found an excerpt from Geneen Roth’s book Women, Food and God. It’s a book already beautifully covered by associate editor and Weightless blogger Margarita Tartakovsky here. So I’m not going to g... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5028458 Tue, 12 Jul 2011 10:17:36 +0100 5028458 http://www.medworm.com/index.php?rid=5008659&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fv9zwuSemPQw%2F Consider this scenario: Let’s say you sold a leading mouthwash but feared that marketing a test for detecting oral cancer would raise concerns about a study showing a link between the mouthwash and oral cancer. Would you proceed or break the contract? Well, Oral Cancer Prevention, which makes such a test, claims Johnson & Johnson, which sells Listerine, reneged on a deal. And so Oral Cancer Prevention has filed a lawsuit charging J&J with suppressing sales of a test that allegedly could have prevented an estimated 7,300 cases of oral cancer and an unknown number of deaths in order to protect Listerine, which generates some $1 billion in annual sales. The company notes oral cancer is difficult to detect until its later stages, but its OralCDx test would help dentists detect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008659 Fri, 08 Jul 2011 14:32:40 +0100 5008659 http://www.medworm.com/index.php?rid=5008664&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcgppHEcmtPk%2F After months of speculation and debate, Pfizer is now looking to sell or spin off its Animal Health and Nutritional businesses, although the drugmaker has apparently had a change of heart about its Consumer Health operation and appears committed to keeping the unit. The move comes after Pfizer signaled its intention several months ago to start disposing of major operations in a bid to focus mostly on pharmaceuticals, prompting a debate about the extent to which Pfizer can successfully transform itself into a growth company, even though shedding the Animal Health and Nutritional units could yield recognizable benefits (read this). “Both Animal Health and Nutrition are strong businesses with attractive customer bases and solid fundamentals, but distinct enough from our core businesses ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008664 Thu, 07 Jul 2011 13:29:55 +0100 5008664 http://www.medworm.com/index.php?rid=4992989&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl9r_qs2CrEo%2F Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments. In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these polici... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992989 Sat, 02 Jul 2011 14:04:29 +0100 4992989 http://www.medworm.com/index.php?rid=4992990&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLVsy771S9hA%2F The FDA may want to yank the breast cancer indication for Avastin, but the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage. “As long as doctors continue to prescribe it, we will continue to pay, even for an off-label use, until and unless some time in the future we decide to change our coverage policy. We have no such thing underway at this time,” a CMS spokesman tells us. “We often pay for off-label use of drugs, but not always.” The move will, no doubt, cheer many breast cancer patients and their loved ones, who feared the FDA would soon put Avastin out of reach (look here), now that an agency advisory panel unanimously voted - once again - to rescind the indication. The vote came earlie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992990 Fri, 01 Jul 2011 16:36:13 +0100 4992990 http://www.medworm.com/index.php?rid=4992994&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQp-xlA4Oic4%2F Few topics are more contentious than ghostwriting - the mysterious practice in which an article lands in a medical journal with the names of various authors who, as it turns out, had little or nothing to do with the substance of the publication. The issue has caused several scandals for several drugmakers and medical journals, causing embarrassment and turmoil. However, keeping track can be difficult. So the Project On Government Oversight, a watchdog group that regularly probes the topic, has compiled a handy primer on recent episodes (read here, here, here, here and here), as well as the steps taken by various universities and government agencies to cope with the problem. In case you were wondering, though, allegations have been reported for the following journals: The American Journal ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992994 Fri, 01 Jul 2011 12:30:53 +0100 4992994 http://www.medworm.com/index.php?rid=4992996&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIKpuqSGxcXI%2F Good morning, everyone. And how are you today? Another beautiful morning is rising over the Pharmalot corporate campus. However, we will be rolling in the sidewalks early as we prepare for a long weekend on this side of the pond. Our modest agenda includes a dip in the pool, hanging with the short people, catching up on some research (with thanks to our sources) and one of our favorite sports - hunting for mice. What about you? Anything special planned? Maybe a ride in the country, a barbecue in the backyard or how about a day at the beach? This will be Independence Day, after all, so perhaps this is a good time to think of suggestions for trimming the national debt. The symbolism is heavy, yes? Whatever you do, have a great time and be safe. See you soon… Glaxo Kicks Off Sale Of OTC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992996 Fri, 01 Jul 2011 11:50:16 +0100 4992996 http://www.medworm.com/index.php?rid=4992757&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F01%2Fbest-of-our-blogs-july-1-2011%2F Once I got to college, I began to love school. The feeling of working hard and then the instant gratification from all that hard work was awesome! One professor told me I’d be a professional student forever. Of course in the real world, you can work as hard as you want and still feel like you haven’t quite made it. And it’s not just your career, but that gnawing, frustrating feeling could also apply to friendships and romantic relationships too. I realized that the formulas that seem to work in school, working hard = A’s, just didn’t have a place in real life. Sometimes you could drive yourself crazy trying to force pieces of a puzzle that just didn’t go together. In the whole process of going to school and finally getting out of it, I realized it was�... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4992757 Fri, 01 Jul 2011 11:10:08 +0100 4992757 http://www.medworm.com/index.php?rid=4984688&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F00EJHTbmsSw%2F Three years after the FDA linked the Heparin scandal to contaminated supplies from China, the House Energy and Commerce Committee is expanding a probe into the episode and wrote 10 drugmakers, manufacturer reps and ingredients suppliers for documents, because the agency has indicated they have info about the Chinese heparin industry and supply chains. The move comes after the committee has twice lashed out at the FDA for failing to find those responsible for the scandal, which was linked to 81 deaths in 2007 and 2008 and traced to heparin sold by Baxter International (back story). The fatalities provoked harsh criticism of the FDA for not conducting greater oversight of foreign facilities - particularly those in China that make medicines or supply active pharmaceutical ingredients. Baxter... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984688 Thu, 30 Jun 2011 11:55:31 +0100 4984688 http://www.medworm.com/index.php?rid=4984498&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F29%2Fthe-illusion-of-confidence%2F We often overestimate our abilities, and overestimate the abilities of others who exude confidence.  Are we correct in thinking the athlete who radiates confidence must be competent in her/his sport?  The salesman who speaks with extensive knowledge and confidence must know what they are talking about, right? These scenarios are often manifestations of the illusion of confidence. Confidence is often considered a “true” signal of the extent of one’s memory, knowledge, skill, and ability.  However, confidence is often misleading and not congruent with ability.  This type of unwarranted confidence leads to “epistemic irrationality,” or more commonly known as simply delusion and self-deception. The illusion of confidence has two distinct but related aspects.  Fi... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4984498 Wed, 29 Jun 2011 19:12:36 +0100 4984498 http://www.medworm.com/index.php?rid=4984693&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIkIZCh14KuA%2F After years of embarrassment, lobbying and litigation, The Medicines Company last week finally succeeded in convincing Congress to support what has been derisively called the ‘Dog Ate My Homework Act.’ In reality, this was not a separate bill, but an amendment to the patent reform legislation known as the America Invents Act. The amendment was designed to compensate for a mistake that occurred a decade ago, when the drugmaker sought a patent extension for its Angiomax anti-coagulant, but its lawyers missed the filing deadline by one day, a contentious point that the law firm denies (see comment below). And so the amendment, which was introduced by four members of the House, would retroactively alter the process used to review filings - and grant an additional day (read the amen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984693 Wed, 29 Jun 2011 14:35:16 +0100 4984693 http://www.medworm.com/index.php?rid=4976204&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2jyWx_FI6TU%2F Now that Carl Icahn has scooped up nearly 7 percent of Forest Laboratories stock and wants to place four of his minions on the board (back story), Wall Street is eyeing the drugmaker as takeover bait. The premise is helped along by the fact that Forest has five newer products, including three that will be launched by September, and another four in the pipeline that, when taken together, could add up to an attractive package. To wit, these nine drugs have the potential to dramatically boost earnings over the next five years, according to an investor note from Credit Suisse analyst Catherine Arnold. In her view, a mere 5 percent rise in 2016 sales implies a 24 percent earnings gain. This is particularly important since the Lexapro antidepressant, which generated 53 percent of 2011 sales, los... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976204 Tue, 28 Jun 2011 12:57:12 +0100 4976204 http://www.medworm.com/index.php?rid=4976206&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvinqO6QozGE%2F Hello, again. And how are you this morning? A beautiful day is unfolding here on the Pharmalot corporate campus - the birds are chirping, the official mascots are lounging about and the cup of stimulation is brewing. Meanwhile, we are looking forward to another day of R&D. We know you can relate. To help you along, here are some tidbits. Hope your day goes well and stay in touch… Vertex Tops Merck In Hep C Drug Launch (The Street) Glaxo R&D Chief Says Advair Is Safe From Generics (Reuters) J&J Plans To Market More Products Under The Janssen Name (Financial Times) New Prostate Cancer Drugs Are Expensive (New York Times) Amgen Sells $3 Billion In Bonds To Pay For Dividends (Bloomberg News) Diabetes Cases In Adults Worldwide Has Doubled In 30 Years (Reuters) India Suspend... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976206 Tue, 28 Jun 2011 11:45:08 +0100 4976206 http://www.medworm.com/index.php?rid=4975942&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F28%2Fbest-of-our-blogs-june-28-2011%2F Sometimes when I’m in need of a little inspiration, I head out for a short walk. Today, as I meandered through the tree lined path of my apartment complex, I found it. I kept ending up in the direction of a beautiful fountain. The sound of the water as it sprung up in the air like fireworks and then gently falling as it lapped softly against the rocks was soothing. I thought about what the water represented, that regardless of whether it was thrust up in the air or moved gracefully to the bottom, it was the same unchanged substance. I realized that no matter what you did to it, the water was still water flowing in a fountain. The same could be said about you. You may have emotions that carry you from the highest mountain peaks to the valley lows, but you are at the core that unchange... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4975942 Tue, 28 Jun 2011 10:11:39 +0100 4975942 http://www.medworm.com/index.php?rid=4960332&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9IIE_5WYjus%2F Top of the morning to you. Another busy day here on the Pharmalot corporate campus, where we continue our own version of R&D - you know, reading documents and learning interesting tidbits - amid meetings and deadlines. We trust you can relate. So please join us for that mandatory cup or three of stimulation. What would do without them? Meanwhile, here are some headlines from around your world. Have a great day and stay in touch… FDA Concludes Silicone Breast Implants Are Mostly Safe (Associated Press) Merck KGgA Abandons Plan To Seek FDA Approval For MS Pill (Reuters) FDA Panel Votes Against Recommending Novartis Gout Drug (Dow Jones) High-Dose Statins May Cause Diabetes (MedPage Today) EU Updates Tysabri Warning Label (Associated Press) AstraZeneca Sells Tech Unit To Dentsply F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960332 Wed, 22 Jun 2011 11:43:04 +0100 4960332 http://www.medworm.com/index.php?rid=4953365&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzehib3Dyut8%2F For the past five years, the US Attorney in Brooklyn, New York, has been investigating Amgen for allegedly violating the False Claims Act. At issue are a host of allegations, most notably that Amgen violated HIPAA and offered kickbacks to doctors in order to boost sales of its various meds and steal market share from such rivals Johnson & Johnson. Along the way, however, the biotech believed an agreement was reached in which the government would coordinate contact with current Amgen employees, but then argued the understanding was breached when the feds began attempting to conduct interviews and subpoena documents. And so last year, Amgen filed a protective order, but late last week, a judge upheld an earlier recommendation (see this) and ruled the feds can continue pursuing Amgen emp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953365 Mon, 20 Jun 2011 16:28:30 +0100 4953365 http://www.medworm.com/index.php?rid=4945197&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6lF6tGbTdbE%2F And so, another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. For now, we intend to do some reading, catch up with our short people and promenade with the official Pharmalot mascots. And you? Anything special? Perhaps a drive in the country? A chance to meet with friends? Or maybe balance your checkbook and show the indebted nations how it’s done? Whatever your fancy, have a great time. Oh, and say ‘hi’ to Dad… FDA Reviewers Say Novartis Gout Drug Data Is Complicated (Reuters) Roche Faces Significant Hurdles For Avastin Breast Cancer Indication (Financial Times) UK Officials Say Pfizer Doing ‘Too Little’ As Plant Closes (BBC) FDA Approves Expanded Use Of Celgene Lymphoma Drug (Reuters) AstraZene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945197 Fri, 17 Jun 2011 12:15:14 +0100 4945197 http://www.medworm.com/index.php?rid=4952993&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F17%2Fbest-of-our-blogs-june-17-2011%2F Most therapists, even before they were therapists, have a natural ear for pain. They are like magnets attracting people who are in dire need of a listener. I know because I was one of them. And over the years, I’ve learned that the real challenge underlying all of the stuff they talked about was acceptance. People felt rejected, heartbroken, beaten up emotionally because they felt that the life they were living wasn’t the life that they were supposed to be living. They mourned their inability to look a certain way, be a certain kind of person or get married and have kids by a certain age and be nurtured unconditionally by two loving parents. But life never unfolds the way we think it’s supposed to. And there is a lot of grief in that. One of the most painful things to con... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4952993 Fri, 17 Jun 2011 11:07:40 +0100 4952993 http://www.medworm.com/index.php?rid=4945202&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FR1Ow0TKVHtA%2F Depends who you ask. So more than 180 business development executives that handled dealmaking activities between 2006 and 2010 were queried and, not surprisingly, the most popular response from biotechs, or 36 percent of the respondents, was that licensees have greater power in driving deal terms thanks to current environment, according to a pair of dealmaking advisers who offer their views on Nature News Drug Discovery. But….the most popular response at drugmakers - 44 percent, to be prescise - was the opposite: they believe their negotiating power has increased with biotechs. Meanwhile, 55 percent at biotechs felt that upfront payments have dropped, compared with 31 percent who saw an increase. Over at pharma, 51 percent saw an uptick in upfront payments and only 32 percent saw a d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945202 Thu, 16 Jun 2011 12:36:05 +0100 4945202 http://www.medworm.com/index.php?rid=4934336&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F14%2Fbest-of-our-blogs-june-14-2011%2F I have a “friend” who spent their entire 2010 stuck in what-ifs. What if I lose my job? What if I never feel better? What if my dreams don’t come true? Do you have a friend like that? Do you have a friend who attacks your self-esteem by laughing at your mistakes, criticizes your weaknesses and points a finger at your flaws. Worse yet, does she ever say, “You won’t ever be successful in life” because all your efforts are “just not good enough.” Some kind of friend right? But what if I told you that friend was not a friend at all, but your thoughts. Closer to you than any friend would ever be, this inner self-critic sits on your shoulders and constantly berates you. That type of constant negative feedback will wear on a person’s soul and ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4934336 Tue, 14 Jun 2011 11:17:46 +0100 4934336 http://www.medworm.com/index.php?rid=4911818&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6PnSSHy9aJg%2F In explaining his decision to penalize Johnson & Johnson a healthy $327 million for deceptive marketing of its Risperdal antipsychotic, South Carolina Circuit Court Judge Roger Crouch late last week made a point of reciting a part of the famed credo that is religiously repeated by execs at the health care giant: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must be of high quality.” Why? He wanted to contrast the credo with actions taken by the Johnson & Johnson team. To set the stage for his remarks, Crouch offered this: “It it is the loss of the company’s focus, upon the primary objective of its credo, which bri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911818 Wed, 08 Jun 2011 12:08:23 +0100 4911818 http://www.medworm.com/index.php?rid=4911571&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F08%2Fhow-to-do-great-work-and-a-giveaway%2F When you’re on the job, you might feel like the last thing you’re doing is meaningful work. Like you’re stuck in a rut and just going through the motions. Email? Check. Phone calls? Check. Data entry? Check. Meeting? Check. Lunch? Check. More email. More calls. Home. Whether or not your days feel this mundane, you still might not be involved in exhilarating, engaging work that makes you happy. In Do More Great Work, Canadian coach Michael Bungay Stanier — founder of the company Box of Crayons — helps readers “stop the busywork, and start the work that matters.” Specifically, the book features a variety of exercises, which Stanier calls maps, and thought-provoking questions that help readers figure out what their own meaningful work is and how to do more of it. (It... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4911571 Wed, 08 Jun 2011 10:15:12 +0100 4911571 http://www.medworm.com/index.php?rid=4911574&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F07%2Fbest-of-our-blogs-june-7-2011%2F Life lessons come in unexpected packages. Take yesterday, for example. I was peering into my nightly stack of “I’m-going-to-eventually-get-to-these-books,” when I came across the yellow covered copy of Frances Hodgson Burnett’s The Secret Garden. The only reason why I hadn’t finished yet, is that I did what I normally do when I’m infatuated with a book. I read it slowly as if each word were being analyzed with a microscope. I would ponder over an author’s choice of one word over another, for example or got lost in why a particular passage was so magical, so descriptively perfect. When I picked up where I left off, I was enchanted by the beginning of the last chapter, which started with this: ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ “[... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4911574 Tue, 07 Jun 2011 11:32:53 +0100 4911574 http://www.medworm.com/index.php?rid=4902693&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7xm5seVkAgw%2F Several big drugmakers have agreed to slash prices on some of their vaccines, which are distributed to poor people in developing countries by the Global Alliance for Vaccines and Immunizations, the non-profit that was established by Bill Gates. The move comes just days before a widely anticipated GAVI board meeting that will address, in part, plans to raise $3.7 billion in needed funds. The price cuts are being offered by Merck, GlaxoSmithKline, Johnson & Johnson’s Crucell unit, Sanofi Pasteur’s Shantha Biotechnics, Bharat Biotech and the Serum Institute, and should help GAVI reduce the funding gap for commitments that run until 2015. The effort involves vaccines to combat rotavirus and HPV, as well as diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902693 Mon, 06 Jun 2011 15:38:52 +0100 4902693 http://www.medworm.com/index.php?rid=4902695&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FufcencyVRaY%2F The decision late last week by a South Carolina judge that Johnson & Johnson must pay $327 million for deceptive marketing of its Risperdal antipsychotic will likely hasten a global settlement the health care giant has been pursuing to resolve a raft of litigation and investigations. You may recall that, two months ago, J&J set aside an unspecified amount of money to be used to settle some of the litigation. The Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states have been probing off-label Risperdal marketing for years (back story). Now, the tab is mounting. The case is the third of about 10 state lawsuits over Risperdal marketing. J&J sco... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902695 Mon, 06 Jun 2011 13:24:07 +0100 4902695 http://www.medworm.com/index.php?rid=4893556&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F03%2Fbest-of-our-blogs-june-3-2011%2F It’s easy to slip into the “coulda, woulda, shouldas” of our lives. There’s the trip you didn’t take. The relationship you might have ended too soon. The career that sits, still waiting to be pursued. And though it maybe difficult to admit, it’s not the boss that held you back or the friend that slighted you. In fact, there’s probably some true to the saying that “you are your own worst enemy.” It’s the weekend again. It’s June. Summer is upon us. Why not take the time to reflect on why you’re holding yourself back? A few days ago, I asked our Facebook friends what’s the best decision they ever made. It was one of our most popular topics and we received responses on everything from living to accepting their life.... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4893556 Fri, 03 Jun 2011 11:16:55 +0100 4893556 http://www.medworm.com/index.php?rid=4872473&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FliBV1h4EAXA%2F File this under sticking point. The Global Alliance for Vaccines and Immunizations is coming under fire because a large vaccine maker that provides most of its income is about to become a pharma representative on its board. The move is prompting concerns about conflicts of interest amid demands for lower vaccine prices, The Financial Times writes. In July, Johnson & Johnson’s recently acquired Crucell unit will replace GlaxoSmithKline on the GAVI board (see this), which next month meets in London in hopes of raising $3.7 billion. But some non-governmental organizations say GAVI, which last year sent $825 million in donor funds to vaccination programs in poor countries, is not doing enough to lower prices paid for vaccines. “We think some conflicts are too big to manage,”... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872473 Fri, 27 May 2011 13:02:26 +0100 4872473 http://www.medworm.com/index.php?rid=4872476&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl6OCIRjRzwE%2F And so another working week is about to come to an end, which means we can daydream about weekend plans. Our modest agenda includes hanging out with the short people and catching up on some reading. What about you? Maybe a dip in the pool? A walk in the park? Perhaps gazing into the future? This side of the pond has a three-day break, of course, so there will be more time to indulge. Whatever you do, have a great time and see you soon… Novartis Found Not Liable For Jaw Disease (Reuters) Medco Loses Blue Cross Blue Shield Contract (Reuters) Trimeris Gets $5M In Roche Settlement (Triangle Business Journal) Pharma Protests UK Pricing Plan (Bloomberg News) AstraZeneca Confirms Endings Payments For Docs To Attend Meetings (Reuters) CMS Proposes Looser E-Prescribing Rules (Internal Medicin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872476 Fri, 27 May 2011 12:09:07 +0100 4872476 http://www.medworm.com/index.php?rid=4862634&cid=t_102041_109_f&fid=34752&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPsychsplash%2F%7E3%2FovqaR0_pg1c%2F URL: http://www.mincava.umn.edu/The Minnesota Center against Violence and Abuse (MinCAVA) has information on these subjects: child abuse, domestic violence, sexual violence, stalking, trafficking, workplace violence, youth violence and more. Most information is in PDF form, but some are in regular text or web pages. For: AnyoneTopics: Abnormal, Academia, Addiction, Anger, Behaviour Management, Child and Adolescent, Clinical Psychology, Common Factors, Depression, Emotional Health, Family Therapy, General Psychology, Life, Lifestyle, Mental Health, Mental Health Promotion, Post Traumatic Stress Disorder, Quality of Life, RelationshipsFeatures: Articles, Grants & Funding, Information, Links, Multimedia, Resources We are an online resource community only.  Our services are limited t... PsychSplash blogs http://www.medworm.com/rss/comments.php?id=4862634 Wed, 25 May 2011 17:00:13 +0100 4862634 http://www.medworm.com/index.php?rid=4862925&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYGVnVGNyT4k%2F Hello, everyone, and top of the morning to you. A lovely day is emerging here on the Pharmalot corporate campus, although this will be a busy one as we prepare for those meetings and deadlines. We know you relate, so please join us for a cup of stimulation - our flavor today is Rain Forest Nut. Or grab a bottle of water if you prefer. Meanwhile, here are some tidbits from around the world, such as it is. Hope your day is swell and you achieve your goals. See you later… SEC Expected To Act On Whistleblower Program (Washington Post) Deaths In Pfizer Arthritis Drug Trial Are Under A Microscope (Reuters) Vertex And Its Small, But Experienced Sales Force (Dow Jones) Watson Pays $562M For Generic Drug Developer (Reuters) Bayer and J&J’s Xarelto Prevented Repeat Strokes In Analys... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862925 Wed, 25 May 2011 12:02:24 +0100 4862925 http://www.medworm.com/index.php?rid=4862632&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F24%2Fbest-of-our-blogs-may-24-2011%2F Saturday’s end of the world scare probably didn’t send you in a panic. Or maybe it did. Just a little? I know it wasn’t on my mind until two baristas decided to turn a boring day into an exciting one by counting down the last ten seconds to the end of the world. I started to think about how sad it would be if it were to all end here… before I had the chance to write that book I’ve always wanted to write, travel the world or own a home. A few days later, I began to think about the people in my life that I was unintentionally taking for granted (including me!). It turned a false alarm into an opportunity to revisit my priorities and rethink the way I was treating loved ones in my life. This week’s top posts reminded me of that. I think you will find new co... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4862632 Tue, 24 May 2011 10:42:40 +0100 4862632 http://www.medworm.com/index.php?rid=4853217&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZdvfQlG4ejw%2F The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here). Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.” And he complains that he encountered “great ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853217 Mon, 23 May 2011 18:19:57 +0100 4853217 http://www.medworm.com/index.php?rid=4853218&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYC8nXoQY5XE%2F In the latest example of who antipsychotics are being prescribed inappropriately, Florida’s state-run jails and residential homes are regularly giving large doses of the meds but not for uses that were approved by the FDA. And in some cases, the drugs are prescribed by contract doctors who have taken speaking fees and other gifts from drugmakers, according to The Palm Beach Post. As a result, the state’s Department of Juvenile Justice has ordered a review. “The questions recently brought to our attention are serious, and deserve answers based on a careful, thorough and independent review of the facts,” DJJ Secretary Wansley Walters tells the paper, which ran a two-part series about the problem (read here and here). The series raises familiar questions about the exte... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853218 Mon, 23 May 2011 15:08:23 +0100 4853218 http://www.medworm.com/index.php?rid=4853221&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fpok9CMr79cQ%2F Hello, everyone, and welcome to the working week. Another overcast day is unfolding here on the Pharmalot corporate campus, where we will be hosting a webinar on the injectable delivery drug market, so please join us. Meanwhile, the time has come to grab a cup of stimulation and peruse the news of the world. Hope your day goes well and stay in touch… FDA Approves Vertex Pharma Hepatitis C Drug (Reuters) Lilly Helps Create Biotech To Develop And Sell Xigris (Associated Press) How PR Tactics Skew Medical Research Presentation (The Guardian) J&J Woes Mitigated By New Drug Bets? (Bloomberg News) Lilly Chops 70 Jobs In Ireland (InPharm) Two Men Convicted Of Selling HIV Meds (NewJerseyNewsroom) Google Warned About Rogue Drug Ads (Wall Street Journal) Provenge, Medicare And Costs (CNBC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853221 Mon, 23 May 2011 11:59:53 +0100 4853221 http://www.medworm.com/index.php?rid=4852940&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F22%2Fam-i-a-defensive-pessimist%2F Photo credit: vrogy (Flickr) This blog post, I’m convinced, will be a real disaster. I mean, just think of all the things that could possibly go wrong! If I post it at the wrong time of day, no one will read it. If I don’t write with super-engaging language and in a clever tone, potential readers will bypass my post for something else on the internet that’s far more exciting. Oh, and I’ll probably (unknowingly!) insert a blatant typo that my eyes refuse to notice — even after several rounds of proofreeding. Or proofreading. Yeah, that second one. I’ve painted a pretty gloomy picture there, haven’t I? It feels a little awkward to admit that I’m a pessimist. The world really seems to be riding the wave of optimism these days, at least as far as... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4852940 Sun, 22 May 2011 22:14:59 +0100 4852940 http://www.medworm.com/index.php?rid=4848149&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnYI5PNwOxzs%2F A Pennsylvania state court jury has ordered Johnson & Johnson to pay $10 million in damages to the family of a 13-year-old girl who suffered skin burns and eye damage after she took Children’s Motrin to treat a fever and cough, Bloomberg News writes. After deliberated for 10 hours over two days, the jury decided that J&J’s McNeil Consumer Products unit was liable for injuries suffered by Brianna Maya, now 13, who was left blind in one eye and suffered burns over 84 percent of her body. The injuries were sustained after she took Motrin in 2000, when she was 3-1/2 years sold. Her lawyer charged J&J didn’t include a warning that year alerting consumers the med can cause Stevens-Johnson Syndrome. J&J companies later warned that ibuprofen, the active ingredient, could ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848149 Fri, 20 May 2011 20:27:29 +0100 4848149 http://www.medworm.com/index.php?rid=4848154&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkTurjNnKuyc%2F And so another working week will soon draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes yardwork, hanging with assorted short people and another installment in the ‘Let’s-see-them-before-they-die‘ concert series. And you? Anything special in the pipeline? How about curling up with a good e-book? Or a dinner with a favorite someone? Or maybe just a walk in the park? Whatever you do, have a great time and be safe. See you soon… FDA Approves J&J HIV Med For Combo Use (Reuters) EU OKs Bloodthinner From Pfizer And Bristol (Associated Press) EMA Approves Glaxo And Human Genome’s Benlysta For Lupus (Reuters) Pfizer Truck Robbed On Way To CVS (Securing Pharma) AstraZeneca To Eliminate 135 Jobs In Massachus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848154 Fri, 20 May 2011 11:39:57 +0100 4848154 http://www.medworm.com/index.php?rid=4841579&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F19%2Fmyths-about-memory%2F Memory is important in everyday judgments and decision-making.  In some way or another, memory affects most aspects of our lives.  It is no surprise that there are many myths about memory. Memory involves processing of information in different stages: sensory, short-term, and long-term.  However, the mechanics of memory are not my concern in this article. Here, I’ll focus on a couple of popular myths about memory.  Donald Varakin, cognitive scientist, sheds light on these myths. So I posed the following question to Dr. Varakin… I am aware there are numerous myths about memory.  What have you found to be the two most common myths? It’s probably hard to limit it to two, but assuming you can only give us two, what would they be? Here’s Dr. Varakin’s reply: ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4841579 Thu, 19 May 2011 20:30:39 +0100 4841579 http://www.medworm.com/index.php?rid=4841982&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsZRvZcrYmVA%2F Fewer than half of the claims in advertisements that appear in leading medical journals aimed at ear, nose and throat specialists are actually supported by data referenced by the advertisers, according to a new study in Archives of Otolaryngology. And the finding suggests that doctors may be misled by the content of the ads. The researchers chose a sample of 50 claims from 23 ads that ran in four leading journals and sent them to five specialists, who were asked to compare the claims to references listed in the ads. The upshot? Only 28 percent of the claims were strongly supported by the referenced data, but 12 percent of the time, the data actually contradicted the claims (here is the abstract). The issue is troublesome, the lead researcher says, if busy docs may rely on one-line glossy ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841982 Thu, 19 May 2011 14:12:16 +0100 4841982 http://www.medworm.com/index.php?rid=4841986&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQdEauZbTgWI%2F There is nothing new or surprising that fewer government funds are available for state AIDS Drug Assistance Programs, or ADAPs. But the crisis is growing. As of May 12, there were 8,100 people on AIDS Drug Assistance Program, or ADAP, waiting lists in 13 states, which is a whopping 706 percent increase from 1,004 individuals in 10 states who were on ADAP waiting lists exactly a year ago. Meanwhile, 16 more state ADAPs have undertaken various cost containment strategies, such as reducing formularies and capping enrollment, over the past two years. This is up from 10 states at this time last year, according to the latest report from the National Alliance of State & Territorial AIDS Directors. And five other states are considering the same measures (see here and here). For those who may ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841986 Thu, 19 May 2011 11:48:35 +0100 4841986 http://www.medworm.com/index.php?rid=4841987&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPnFE-Cg3WGw%2F Good morning, everyone, and how are you today? Here on the Pharmalot corporate campus, we are engaged in the off-to-the-school-house hustle. This calls, of course, for a cup or two of stimulation. How else to gear up for those meetings and deadlines? So please feel free to join us. And here is another invitation: our webinar next week on the injectable drug delivery market. Meanwhile, we offer you these tidbits of the world at large. Have a great day and do stay in touch… North Carolina Delays Vote On Preemption Bill (Associated Press) CDC Blog On Zombie Apocalypse Proves Apocalyptic (AdWeek) Takeda To Buy Nycomed For $13.6 Billion (Reuters) Bill Gates Calls For A ‘Decade Of Vaccinations’ (Pharma Times) J&J Failed To Warn Parents Of Motrin Risks: Lawyer (Bloomberg Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841987 Thu, 19 May 2011 11:47:58 +0100 4841987 http://www.medworm.com/index.php?rid=4841988&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBLRCl_3VzoU%2F Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks (back stories here, here and here). Nonetheless, the agency made clear there would significant restrictions on accessibility to patients who are unable to control their illness by using other meds. For instance, doctors will have to document patient eligibility and patients will have to review statements describing CV safety concerns associated with Avandia and acknowledge they understand the risks. Today, though, the FDA announced the Risk Evaluatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841988 Wed, 18 May 2011 23:02:52 +0100 4841988 http://www.medworm.com/index.php?rid=4841587&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F17%2Fbest-of-our-blogs-may-17-2011%2F Do you feel it in the air? It’s change. Every season has an end. And with any end comes fear, uncertainty and sometimes sadness. Even if ends bring new beginnings like a marriage, a baby or a new career, the loss of what we know can feel earth shattering. Instead of embracing change, we grasp on, holding desperately to what was instead of what will be. Does that sound like you? How are you continuing to do things that don’t serve you or your new life out of fear of change? Maybe you need to take the time to grieve for your old self and your old life so that you can embrace your new one. It’s something important to contemplate this week as we get closer to summer. It also fits with one of our posts on transitions. Have a great week and enjoy! Seven Rules of Mindful Eating ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4841587 Tue, 17 May 2011 13:50:25 +0100 4841587 http://www.medworm.com/index.php?rid=4829305&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9d0neOmCpbU%2F Late last week, the FDA approved a much-anticipated hepatitis C treatment from Merck, which the drugmaker inherited as part of its acquisition of Schering-Plough (see here). The move, which is the first FDA endorsement of a new hepatitis C med in a decade, came just 10 days before Vertex Pharmaceuticals is expected to win approval of its own drug, setting off a new round of speculation about what is certain to be an expensive and highly interesting battle. The US market alone offers substantial potential with an estimated 3.2 million Americans suffering from the afflication, including an untold number who may not be aware they are infected. Both Merck and Vertex, of course, will work hard to raise awareness. And their meds would be used in combination with older treatments - peginterferon ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829305 Mon, 16 May 2011 13:09:51 +0100 4829305 http://www.medworm.com/index.php?rid=4821146&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7KSZTBkkGu8%2F Two months ago, Pfizer disclosed that talks are under way with the US Department of Justice to settle charges the drugmaker committed fraud against government health programs by failing to report discounts and rebates for its Protonix heartburn med. And at the time, Pfizer also disclosed the feds alleged its potential liability is more than $2 billion (see here). How are the talks going? Well, the US Attorney in Boston has just asked for a trial date to be set sometime in the first half of 2012 (read the motion). This might seem like a long time from now, but the move suggests the government is attempting to pressure the drugmaker to resolve the charges over the next few months or face the unpleasant prospect of going to trial. Given its track record, the drugmaker might just choose to set... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821146 Fri, 13 May 2011 16:37:29 +0100 4821146 http://www.medworm.com/index.php?rid=4821149&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSDqAl15JK8k%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Huron Consulting hired Mark Linver as a managing director in the life sciences practice to handle aggregate spend, merger integration requirements, contract management, government pricing and accrual analysis. Previously, Linver served as a sen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821149 Fri, 13 May 2011 12:19:00 +0100 4821149 http://www.medworm.com/index.php?rid=4821150&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYw_11Z337sQ%2F And so another working week will soon draw to a close. Already, we are daydreaming about weekend plans. Our modest agenda includes mowing the lawn (again), catching up on some reading and taking one of the short people to watch a soccer match. And you? Anything special in the works? Maybe a drive in the country? A mysterious rendezvous? Or perhaps some spring cleaning is in order? Whatever you fancy, have a great time. But, of course, go safely. Meanwhile, here are some tidbits. See you… Shire Is A Takeover Target (Bloomberg News) Iperian Fires Top Execs (Xconomy) UK’s NICE Backs Merck And J&J’s Simponi For Rheumatoid Arthritis (InPharm) Prescription Drug Price Increases Cannot Go On Forever (Reuters) Ranbaxy Hopes To Supply Nexium To US By Year’s End (Economic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821150 Fri, 13 May 2011 12:01:46 +0100 4821150 http://www.medworm.com/index.php?rid=4820921&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F13%2Fbest-of-our-blogs-may-13-2011%2F Marketers are so good at making it sound like your problems will disappear with a sweep of their magic wand. It could be a pill, the perfect exercise machine, skin cream, a juicer or the latest gadget to cure whatever ails you. And we want to buy into the magic. It’s so easy to want to believe that life’s greatest issues can be cured with a single product or belief. But in most cases, real change takes hard work-deep in the trenches kind of hard. Sometimes we’re not ready to face that change. Believing in easy solutions can feel like an easy remedy when the truth of what we need to do is too great. Are you going through this now? Is there something you have been denying that needs your attention? Hope you’ll take some time this weekend to revisit the things in your ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4820921 Fri, 13 May 2011 12:00:01 +0100 4820921 http://www.medworm.com/index.php?rid=4820922&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F12%2Funderstanding-research-methodology-5-applied-and-basic-research%2F In conclusion, I will leave you with the words of Keith Stanovich: [I]t is probably a mistake to view the basic-versus-applied distinction solely in terms of whether a study has practical applications, because this difference often simply boils down to a matter of time.  Applied findings are of use immediately.  However, there is nothing so practical as a general and accurate theory. (2007, p.107) References Stanovich, K. (2007).  How to Think Straight About Psychology: 8th Edition.  Boston, MA: Allyn & Bacon. Photo by Helen Cook, available under a Creative Commons attribution license. (Source: World of Psychology) World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4820922 Thu, 12 May 2011 19:55:10 +0100 4820922 http://www.medworm.com/index.php?rid=4821154&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ0LpPMQNTz8%2F Earlier this week, US District Court Judge Roger Titus acquitted former GlaxoSmithKline lawyer Lauren Stevens of obstructing an FDA probe into alleged off-label marketing of an antidepressant and making false statements to the agency. The surprise move, which came after the same judge tossed an earlier indictment a few weeks ago, was seen by many as a blow to the federal government and its effort to hold some pharma execs accountable for breaking the law (read the transcript of his remarks here). In the aftermath, there was debate about several details, notably the extent to which Stevens fully provided materials to the FDA, as required. We spoke with J. Patrick Fitzsimmons, a lead partner in the life sciences and health care practice group at the Baker & Daniels law firm and a former... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821154 Thu, 12 May 2011 12:52:01 +0100 4821154 http://www.medworm.com/index.php?rid=4813667&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU-E_cUnzOJg%2F Good morning, everyone, and nice to see you again. A busy day is planned here on the Pharmalot corporate campus as we hustle to meet some deadlines and undertake our own version of R&D. No doubt, you relate. So please join us for that mandatory cup of stimulation. Meanwhile, here are some tidbits we found floating about. Hope you conquer the world and see you later… Takeda In Talks To Buy Nycomed For $12 Billion (Bloomberg News) Carl Icahn And His Big Bet On Biotech (The Boston Globe) Glaxo & Astra Hook Up With Academia For Inflammation Research (Pharma Times) Experimental AIDS Vaccine Shows Promise In Monkeys (Reuters) Shire Eyes Big Sales For New Vyvanse Uses (Reuters) Procrit And Epogen May Worsen Heart Attacks (Health Day) Docs Busted For Supplying Oxycodone Network (Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813667 Thu, 12 May 2011 12:15:38 +0100 4813667 http://www.medworm.com/index.php?rid=4813668&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHnEthXoRVjU%2F Nearly a month has passed without a recall from Johnson & Johnson. This may cause recall withdrawal - pun intended - among those closely tracking the plethora of goods the health care giant has yanked over the past year; over-the-counter meds, hip replacement devices, contact lenses, prescription drugs and surgical sutures. But never fear. Bill Weldon may still be ceo, but the problems continue. Today, the Johnson & Johnson is recalling lots comprising an estimated 2,000 or so bottles of its Prezista HIV 400mg med after consumers noticed a musty odor emanating from the packaging. The recalls are taking place in the UK, Ireland, Germany, Austria and Canada. Why? Johnson & Johnson points to trace amounts of TBA found in bottles sourced from a common supplier (see the stateme... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813668 Wed, 11 May 2011 14:09:09 +0100 4813668 http://www.medworm.com/index.php?rid=4813361&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F11%2Fthe-fear-of-making-mistakes-and-interesting-insights-on-being-wrong%2F My whole life I’ve been terrified of making mistakes. When I was giving a talk about Germany in my sixth grade class and the teacher asked me who the chancellor was, it took me a minute to utter his last name — all the while I was stuttering. When I gave presentations in school, I never veered away from my index cards — not even a word. I made myself memorize the words in their exact order — perfectly. If I fumbled, I was a failure. When I started a job in college, the first time I swept the floor, I took an inordinate amount of time. I was worried that if the manager saw any dirt, she’d think that I wasn’t working hard enough to pick up every speck. When I was accepted to grad school, I thought they could sense my stupidity and lack of skill and send me on my way. (Im... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4813361 Wed, 11 May 2011 12:29:54 +0100 4813361 http://www.medworm.com/index.php?rid=4813671&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FR1UQIUsDrSY%2F As lawsuits and investigations pile up concerning alleged illegal marketing of its Risperdal antipsychotic, Johnson & Johnson last month set aside an unspecified amount of money that would be used to settle some of the litigation, according to a filing with the US Securities and Exchange Commission. Some claims, by the way, are civil and others are criminal. Who, exactly, has been looking this issue, though? The answer is more along the lines of ‘who isn’t?’ Peruse pages 25 through 27 (read this) and you will find the Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states have been probing off-label Risperdal marketing for years. Moreov... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813671 Wed, 11 May 2011 12:13:25 +0100 4813671 http://www.medworm.com/index.php?rid=4813672&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUGg3_Y9s14U%2F Hello and top of the morning to you. A sparkly sun is warming the Pharmalot corporate campus this morning, where we are scrambling to cope with a growing assortment of meetings and deadlines. We know you can relate. So please join us for a cup of stimulation - our flavor today is Cinnamon Cream Swirl - as you ready yourself. Meanwhile, here are some tidbits from around the world. Dig in and have a productive day… Arena Plans Shorter Study For Rejected Diet Pill (San Diego Union-Tribune) Medco CEO Sees A Biotech M&A Blitz (Reuters) FDA Asks Hip Makers For Patient Data On Metal Levels In Blood (Bloomberg News) Roche Will Seek Approval For New Skin Cancer Med (Reuters) Sanofi Plans To Revamp Animal Health Unit (Financial Times) Teva Reports A Decline In US Generic Drug Sales (Bloom... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813672 Wed, 11 May 2011 12:09:24 +0100 4813672 http://www.medworm.com/index.php?rid=4803523&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F50hNZC-vxRU%2F On the eve of presenting her defense, former GlaxoSmithKline lawyer Lauren Stevens has asked a federal judge to toss the indictment in which she is charged with obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. If US District Court Judge Roger Titus denies her request, the Stevens team will call its witnesses today. The case is being closely watched for several reasons: it offers the unusual spectacle in which the feds are attempting to make an example of a pharma employee, the proceedings peel back the curtain on the internal machinations that occur when the FDA undertakes a probe and, finally, the trial is pitting the former Glaxo lawyer against some of her former colleages, including lawyers at the King &#038... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803523 Tue, 10 May 2011 12:36:40 +0100 4803523 http://www.medworm.com/index.php?rid=4803232&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F10%2Fbest-of-our-blogs-may-10-2011%2F A friend once asked me how to handle her disobedient son. She was going through a divorce and her son was taking out his pain, confusion and anger about his parent’s relationship on her. She wanted to distance herself from him because he was being so hurtful. But I told her to reconsider. My mom and I have an imperfectly perfect relationship. We’re close. But we rarely see eye to eye on anything. We’re as different as we are alike. I like to find good deals. She loves brand names. She chose a traditional 9 to 5 job. I went the opposite way and designed my own career. At the same time, we’re both sensitive and emotional, which is the perfect recipe for personal and sometimes heated debates. But I have to say one thing. I grew up as a child of divorce too. And I told ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4803232 Tue, 10 May 2011 11:50:07 +0100 4803232 http://www.medworm.com/index.php?rid=4803525&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff59stkxE_2w%2F The unnecessary use of antipsychotics in nursing homes has been controversial for several years. Now, a report from the US Department of Health & Human Services Office of Inspector General finds that, in the six-month period from January through June 2007, 51 percent of Medicare claims for atypical antipsychotics were erroneous. This amounted to a $116 million series of mistakes. The OIG report was generated at the request of US Senator Chuck Grassley, who expressed concern that atypical antipsychotics - the newest generation of such meds - were being prescribed on an off-label basis, given that the side effects associated with the drugs include increased risk of death in elderly persons with dementia. Nursing homes are a big business for these drugs. But as the OIG notes, Medicare re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803525 Mon, 09 May 2011 21:25:07 +0100 4803525 http://www.medworm.com/index.php?rid=4795056&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgtIUt5aYG24%2F How closely tied are professional medical societies to drug and device makers? Just how much money do some receive? And how obvious is the spending at annual meetings? The answers - some have very close ties, get lots of money and the outlay can be enough to burst a blood vessel. Take the Heart Rhythm Society, which is holding its annual to-do in San Francisco this week. For instance, Sanofi-Aventis shelled out a total of $351,00, which was divided this way: $110,000 on programs & guides; another $110,000 on educational support; $96,000 for exhibit space; $25,000 for ‘turndown service,’ and $10,000 for bag inserts and cards. Similarly, Johnson & Johnson spent $386,750. Here’s how: $275,000 for exhibit space and lounge;s $36,000 on educational support; $25,000 for ban... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795056 Fri, 06 May 2011 13:44:32 +0100 4795056 http://www.medworm.com/index.php?rid=4795057&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_eT7KgKAUGw%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Optimer Pharmaceuticals hired Nancy Ruiz as sr vp of R&D. Most recently, she worked at Merck Research Labs, where she was vp of project and pipeline management for infectious diseases. Before that, she was vp of anti-infectives and vaccine... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795057 Fri, 06 May 2011 12:19:38 +0100 4795057 http://www.medworm.com/index.php?rid=4789634&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDTpKxYjCFGk%2F Several drugmakers - including Johnson & Johnson - will discontinue over-the-counter infant drops of meds that contain acetaminophen in hopes of avoiding confusion among parents that can lead to dangerous overdoses. The move was disclosed late yesterday by the Consumer Healthcare Products Association, an industry trade group, which says the phase out will begin later this year. At that time, the OTC makers will only sell a single formula for all children under the age of 12. Right now, the infant formulations on store shelves contain half of the amount of acetaminophen that is found in regular children’s formula. Acetaminophen, you may recall, is a key ingredient in Tylenol, Nyquil and many other OTC meds sold to combat pain and fever. The announcement comes just before an FDA p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789634 Thu, 05 May 2011 12:59:42 +0100 4789634 http://www.medworm.com/index.php?rid=4789635&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh0ku9JI07Eo%2F An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes. And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials. A Novartis spokesperson tells the paper that its clinical trial inves... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789635 Thu, 05 May 2011 12:27:52 +0100 4789635 http://www.medworm.com/index.php?rid=4780482&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FglOPQaumNQs%2F Over the past nine months, GlaxoSmithKline has paid at least $120 million to resolve more than 100 lawsuits claiming some of its Poligrip products caused neurological disorders because the denture cream contains zinc, according to Bloomberg News. The lawsuits allege the drugmaker failed to warn consumers about zinc-related health risks. The disclosure comes just three months after Glaxo began warning consumers about denture creams that contain zinc, and took “voluntary, precautionary” steps to end manufacturing and supplying these denture adhesives due to “health risks associated with long-term excessive use.” Plaintiff attorneys have argued there was no warning for people who apply excessive denture cream to hold ill-fitting dentures, and this can cause problems as severe as ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4780482 Tue, 03 May 2011 20:06:35 +0100 4780482 http://www.medworm.com/index.php?rid=4768244&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaYNq2Yf0nik%2F Earlier this week, Johnson & Johnson clinched a $21.3 billion deal to buy Synthes, and the move offers a significant strategic advantage. To wit, the health care giant gains a market-leading position in trauma products and becomes a dominant player in the $30 billion orthopedic market - one Wall Street analyst estimates J&J will now have a 28 percent share, in fact. What’s more, the acquisition helped catapult J&J stock, which has been battered by an ongoing scandal over the circumstances that led to the recall of tens of millions of products - from over-the-counter meds and contact lenses to hip replacement devices and surgical sutures. The episode has prompted congressional hearings; a consent decree; lawsuits; government probes and lost sales (read here ). Interesti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768244 Fri, 29 Apr 2011 20:07:24 +0100 4768244 http://www.medworm.com/index.php?rid=4768250&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEKnIm6NQuKw%2F Another working week is about to draw to a close. And not a moment too soon. This is, of course, the signal to daydream about weekend plans. Our modest agenda includes a family gathering, mowing the lawn (wish us luck) and promenading with the official Pharmalot mascots. What about you? Does spring cleaning beckon? How about finding recession-era bargains at a garage sale? Or maybe take a moment to think big thoughts? Whatever you do, have a great time. And see you soon… Merck Profits Top Estimates (Bloomberg News) Woman Severely Hurt By Abbott Labs Truck (Lake County News-Sun) Johnson & Johnson Prostate Cancer Drug Approved By FDA (Bloomberg News) Generic Lipitor Ruling Expected Next Week (Dow Jones) FDA Panel Recommends Vertex Hepatitis C Drug (Boston Globe) Wolter Kluwers Buy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768250 Fri, 29 Apr 2011 11:48:24 +0100 4768250 http://www.medworm.com/index.php?rid=4759043&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF7d0dGHppWA%2F Top of the morning to you. Gray skies are hovering over the Pharmalot corporate campus, but our spirits remain sunny. And why not? This inspires us to trot out one of our favorite sayings, courtesy of the morning mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So while you tug on the ribbon, here are a few items to get you started. Have a great day, everyone, and smile… Merck To Buy Back Up To $5 Billion In Stock (Reuters) Teva Resumes Manufacturing At California Site (Orange County Business Journal) J&J Agrees To Buy Synthes For $21.3 Billion (Bloomberg News) Supreme Court Skeptical About Vermont Data Mining Law (Bellingham Herald) Lupin May Wait To Sell Birth Control Pills In The US (Bloomberg News) Merck And Biogen Expand Facilities In North... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759043 Wed, 27 Apr 2011 11:54:02 +0100 4759043 http://www.medworm.com/index.php?rid=4753972&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb_qg-ukLNv0%2F The ongoing refusal by Johnson & Johnson to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and offering lower prices in poor countries, has now generated a scolding from Doctors Without Borders, the international humanitarian organization. In a statement, the group accuses the health care giant of turning its corporate back on HIV patients by undermining access to key AIDS drugs. J&J holds patents on rilpivirine, which is being developed as a first-line HIV treatment, as well as darunavir and etravirine, two meds that treat HIV patients who have become resistent to other drugs. The missive appears carefully timed. Later this week, J&J will hold it annual shareholder meeting,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753972 Tue, 26 Apr 2011 12:28:30 +0100 4753972 http://www.medworm.com/index.php?rid=4747884&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOqLKBxtiNWQ%2F The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice. Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story). The feds want Millar to be comp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747884 Mon, 25 Apr 2011 12:35:59 +0100 4747884 http://www.medworm.com/index.php?rid=4747885&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-f7KG02PNKo%2F Battles between animal-rights groups and drugmakers is nothing new, but the latest spat between the People for the Ethical Treatment of Animals, or PETA, and Merck has a couple of interesting twists. To be specific, PETA late last week filed a lawsuit against Merck for refusing to include a shareholder proposal that would require the drugmaker to disclose its use of animal testing in all research. Merck, however, refused to include the proposal in its proxy, prompting PETA to sue. This marks the first time that the animal-rights group has actually gone to court because a company denied a request to include a shareholder resolution in a proxy. But why exactly did Merck deny the proposal? The drugmaker contends PETA failed to prove shareholder status, even though PETA has owned Merck stock ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747885 Mon, 25 Apr 2011 12:09:46 +0100 4747885 http://www.medworm.com/index.php?rid=4747653&cid=t_102041_109_f&fid=34752&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPsychsplash%2F%7E3%2FHvGYjMfFee4%2F URL: http://www.samhsa.gov/SAMHSA was established in 1992 and directed by Congress to target effectively substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. For: Anyone, Consumers, AnyoneTopics: Behaviour Management, Cognitive Behaviour Therapy, Cognitive Fitness, Cognitive Training, Common Factors, Depression, General Psychology, Health Promotion, Health Psychology, Health and Social Services, Life, Lifestyle, Mental Health, Mental Health Promotion, Quality of Life, Addiction, Attachment, Behaviour Management, Diagnosis, Emotional Health, Health Promotion, Health Psychology, Health and Social Services, Mental Health, Mental Health Promotion, Self-help, Social S... PsychSplash blogs http://www.medworm.com/rss/comments.php?id=4747653 Sun, 24 Apr 2011 17:00:46 +0100 4747653 http://www.medworm.com/index.php?rid=4734209&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F19%2Fbest-of-our-blogs-april-19-2011%2F Have you ever read A Parable by author Barbara Stanny? It’s a story about a farmer who was terribly afraid of an ugly, horrifying monster that lived in the forest near his home so he spent his life building a fence to keep it out. But all that time he devoted to building walls to protect himself prevented him from spending time with his friends and family. When he was finally fed up with being afraid, a fairy godmother appeared and told him how to make the monster disappear. For that to happen he needed to find the monster and embrace it. The farmer was frightened and paralyzed with fear and thought the godmother nutty for suggesting it and himself crazy for thinking of doing it. But, “his pain had gotten worse than his fear.” And he so he faced it by finding the monster,... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4734209 Tue, 19 Apr 2011 12:05:36 +0100 4734209 http://www.medworm.com/index.php?rid=4724262&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeHY6DN5Y0og%2F Hard to believe, yes? But even we take a break now and then. While we have our laptop and Blackberry with us and will, periodically, check on interesting developments, regular posting will not occur this week. We apologize for any inconvenience, but we promised Mrs. Pharmalot and The Short People (that famous, non-existent ’60’s group) that we would focus on their desires. Meanwhile, we hope you enjoy any holidays that you may celebrate. Have a great time, everyone, and see you in a few days… Synthes Confirms Aquisition Talks With Johnson & Johnson (Bloomberg News) Will Amgen Declare A Dividend On Thursday? (Reuters) EU Proceeds With Plan To Cut Patent Costs By 80 Percent (Pharma Times) Merck Scientist Sees Potential HIV Vaccine As Distant Goal (Dow Jones) FDA Warns Patients Ove... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4724262 Mon, 18 Apr 2011 13:00:40 +0100 4724262 http://www.medworm.com/index.php?rid=4724263&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqEprLdN3AJI%2F The deal talks between Johnson & Johnson and Synthes are already winning cautious approval on Wall Street, where one analyst called this “strategically sound.” In an investor note this morning, Wells Fargo analyst Larry Biegelsen writes the reported $20 billion deal “would make Johnson & Johnson the clear market leader in the fast-growing trauma market, build critical mass in the spine segment and further enhance its leading position in the overall orthopedic market.” Indeed, the health care giant, which would gain a line of hip screws, surgical tools and others devices for treating spinal and soft-tissue injuries, could use the move to shore up one of three strategic legs at a time when the others - pharmaceuticals and over-the-counter items - are under p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4724263 Mon, 18 Apr 2011 12:31:42 +0100 4724263 http://www.medworm.com/index.php?rid=4723943&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F17%2Ffeeling-anxious-here-are-3-iphone-apps-to-help-you-relax%2F Photo credit: Helga Weber Digital distractions are everywhere. You’re only two sentences into this blog post, but I’ll bet you’re already thinking about switching tabs to see if you have any comments on that new Facebook wall post you just made. Now you’ve reached the second paragraph, and I know you want to — have to, in fact — refresh your Gmail just one more time. Or check your @replies on Twitter, again, just like you did five minutes ago. Or pull up Reddit, again, hoping to see that red/orange envelope all lit up to notify you of a brand new message. Wait — did you hear something vibrate from across the room? Was it your phone? Maybe you should go and check your texts. Technology can scatter our attention into about a million directions at onc... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4723943 Sun, 17 Apr 2011 21:49:00 +0100 4723943 http://www.medworm.com/index.php?rid=4720082&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnIAKZbKoUes%2F A high-stakes fight between Merck and Johnson & Johnson over the rights to a pair of lucrative arthritis meds - Remicade and Simponi - has finally been resolved. Under the deal, Merck will relinquish exclusive marketing rights to the drugs in various locales: Canada, Central and South America, the Middle East, Africa and the Asia Pacific region as of July 1. But Merck will retain rights in Europe, Russia and Turkey, markets that represent about 70 percent of Merck’s 2010 revenue from the drugs of about $2.8 billion. And the profit split in these markets will be equally divided; before arbitration proceedings began, 58 percent of the profits went to Merck. Meanwhile, J&J will receive a one-time payment of $500 million this month (read the Merck statement and the J&J sta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4720082 Fri, 15 Apr 2011 12:32:59 +0100 4720082 http://www.medworm.com/index.php?rid=4714826&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F14%2Fwhen-physical-exercise-feels-just-like-a-panic-attack%2F Photo credit: Thomas Hawk I’ve had more honest-to-goodness panic attacks in my life than I can count. And by “honest-to-goodness”, I mean the real deal: racing heart, palpitations, nausea, dizziness, shortness of breath, incredibly unsolicited surges of adrenaline…and so on. Simultaneously. Many people — from friends to doctors — told me to start exercising. My friends said it would reduce my stress and help me to sleep better at night. The University of Georgia says it can reduce my anxiety. My doctor told me that getting in shape will reduce heart palpitations and increase my lung capacity. True, true, and true. But here’s the big Catch-22 that kept me from following everyone’s good advice: exercising made me panic. And why? Well, a body ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4714826 Fri, 15 Apr 2011 01:22:48 +0100 4714826 http://www.medworm.com/index.php?rid=4715018&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVldtIyn_Hk8%2F If at first you don’t succeed…indict, indict again. Federal prosecutors have filed a new indictment against Lauren Stevens, a former GlaxoSmithKline lawyer who was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency (back story). The new indictment is not at all surprising. Last month, her lawyers succeeded in convincing a federal judge to toss the initial indictment, because federal prosecutors incorrectly portrayed her defense to a grand jury. However, US District Court Judge Roger Titus also ruled the government can seek a new indictment (read here). Central to the ruling was her contention that she received advice from other Glaxo lawyers, including the King & S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715018 Thu, 14 Apr 2011 18:34:33 +0100 4715018 http://www.medworm.com/index.php?rid=4715021&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWVpdKouXJdQ%2F What would a week be without a Johnson & Johnson recall to discuss? This time, the beleaguered health care giant is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the US last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only 6,000 or so are still circulating. Why is this being done? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials (see the statement). The problem has plagued J&J and Pfizer for some time (see here, here and here). Despite the move, J&J does not anticipate a product shortage and, meanwhile, maintains n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715021 Thu, 14 Apr 2011 14:03:10 +0100 4715021 http://www.medworm.com/index.php?rid=4709422&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2O5tLCPGn9c%2F Major philanthropic foundations, such as the Bill & Melinda Gates Foudation, regularly make the news with their donations and initiatives aimed at improving global health. But there is an aspect to their efforts that may be overlooked - such organizations can have links with drugmakers that could constitute a conflict of interest, according to an analysis published in PLoS Medicine. The researchers examined the five largest US private and/or family foundations that focus considerably on global health - besides the Gates Foundation, the list included the Ford Foundation; W K Kellogg Foundation; the Rockefeller Foundation and the Robert Wood Johnson Foundation, which is a philanthropic outgrowth of a Johnson & Johnson founder. They analyzed publicly available endowment disclosures... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709422 Wed, 13 Apr 2011 14:06:18 +0100 4709422 http://www.medworm.com/index.php?rid=4709423&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-1ZYMxX-gyQ%2F Is the FDA failing to properly oversee medical devices? That’s the take-away message from a new report by the US Government Accountability Office, which says the FDA failed to strengthen its approval and recall procedures, despite a 2009 GAO recommendation that “expeditious steps” should be taken to issue regulations for high-risk devices are approved under the 510K process. This is used to determine if a device is substantially equivalent to another marketed device. Since the last GAO report (read here), the FDA has issued a final rule, but for only one type of device. As of April 1, in fact, agency action on the remaining 26 types of devices is incomplete, according to the GAO. As a result, such devices - including automated external defibrillators and implantable hip d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709423 Wed, 13 Apr 2011 13:17:39 +0100 4709423 http://www.medworm.com/index.php?rid=4709424&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpR8BdZuodiU%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but as you know, our spirits are as sunny as ever and reinforced by a bit of wisdom from the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So while we down our cup of stimulation, we present the news of the world in hopes this will help you cope with those meetings and deadlines. Have a great day and give someone a big smile… BioSante Says FDA Accepts Filing For Male Testerone Gel (Reuters) Merck To Outsource Work Done At Pennsylvania Plant (The Daily Item) Novartis Drug Wins FDA Panel OK For Rare Pancreatic Tumors (Bloomberg News) Pfizer Drug Wins FDA Committee Backing For Pancreatic Cancer (Bloomberg News) Roche’s Xenical Diet P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709424 Wed, 13 Apr 2011 12:12:07 +0100 4709424 http://www.medworm.com/index.php?rid=4704953&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvChY-ezO6Pc%2F Outraged by the track record displayed by Johnson & Johnson ceo Bill Weldon, the American Federation of State, County and Municipal Employees pension fund is urging shareholders to vote against the executive compensation proposals for Johnson & Johnson - and Pfizer, too. Why? Simply put, neither J&J ceo Bill Weldon or Pfizer ceo Ian Read deserve the money they are getting. Reasons To Be Upset? According to AFSCME, despite underperforming its peers over 1- and 3-year total shareholder return timeframes - 5.14 percent in the past year versus 19.15 for rivals, Weldon is one of the highest paid ceo’s making far more than his peers. There is excessive pay and flat share performance during his tenure: over the past nine years, Weldon received nearly $194 million while J&#038... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704953 Tue, 12 Apr 2011 18:01:23 +0100 4704953 http://www.medworm.com/index.php?rid=4704715&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F12%2Fbest-of-our-blogs-april-12-2011%2F In a writing class recently, my teacher said, “Don’t rush the process.” It made me think of a falling feather. I thought of the way a feather floats down gracefully, floating back and forth, slowly like a dance. There is no rushing a feather. Throwing it down forcefully will not make it get to the ground faster. And there would be something heartbreaking if we tried. We would be missing out out on its beautiful, unpredictable path. It’s also a way to think about healing. It’s frustrating to not be there yet. It’s normal to want to be 100% over whatever it is that is ailing you. It’s normal to want to be successful without going through the challenges and obstacles it takes to get there. But remember. No matter how much you want it, forcing it won&#... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4704715 Tue, 12 Apr 2011 11:02:06 +0100 4704715 http://www.medworm.com/index.php?rid=4696951&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7KCIo0qhrdw%2F Given the ongoing problems at the healthcare giant - and the tremendous attention this has generated - it is hardly surprising that some physicians have their doubts about Johnson & Johnson management. You know, the problems include a consent decree; manufacturing gaffes that led to the recalls of tens of milions of products; an alleged cover up of the problems; government probes and reduced sales. And so a Wall Street analyst - David Maris of Credit Agricole Securities - posed a simple question to 100 doctors: Has Johnson & Johnson lost its way? What were the responses? Well, 53 percent reported that they trust J&J as much as ever. A few offered some off-the-cuff explanations, such as “everyone has ups and downs; can’t judge just by one year’s activity.&#8221... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4696951 Mon, 11 Apr 2011 14:46:52 +0100 4696951 http://www.medworm.com/index.php?rid=4693503&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4qYFmFlSQzk%2F The healthcare giant was charged by the US Securities and Exchange Commission with violating the Foreign Corrupt Practices Act by bribing public doctors in several European countries - and paying kickbacks to Iraq - to illegally obtain business. The FCPA forbids US companies from bribing foreign government officials (read here). Specifically, various Johnson & Johnson units paid bribes to public doctors in Greece who chose J&J surgical implants; public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J meds. The subsidiaries - including DePuy and Janssen Pharmaceutica - also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program, according to the SEC complaint. T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693503 Fri, 08 Apr 2011 20:03:33 +0100 4693503 http://www.medworm.com/index.php?rid=4693506&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4zogyJRhrJY%2F Some assignments are more challenging than others. And Denice Torres will certainly have a big mountain to climb now that she is running Johnson & Johnson’s beleaguered McNeil Consumer Healthcare unit, the division responsible for numerous manufacturing gaffes that led to an eye-popping series of product recalls and a spate of troubles for the once-venerable healthcare giant. Since 2009, Torres headed CNS (or central nervous system) for North America Pharmaceuticals for J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit. For two years prior to that post, she was an Ethicon sales and marketing vp, and an Ortho McNeil Neurologics marketing vp. She reports to Pat Mutchler, who was recently named company group chair for US over-the-counter and nutritional products (see this)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693506 Fri, 08 Apr 2011 12:20:38 +0100 4693506 http://www.medworm.com/index.php?rid=4684431&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F06%2Fshould-you-tell-your-employer-you-have-autism%2F April is Autism Awareness Month, and in helping to promote awareness of autism, I’m pleased to provide an excerpt from the book, Living Well on the Spectrum by author Valerie L. Gaus, Ph.D. The book is a self-help book that helps a person with an autism spectrum disorder identify life goals and the steps needed to achieve them. One of the concerns I often hear from people with an autism spectrum disorder is about work and their career. In fact, just last evening while hosting our weekly Q&A on mental health issues here at Psych Central, the question came up whether a person should tell a potential employer about their Asperger’s (the mildest form of autism). While I am not a lawyer, my suggestion was that it probably wasn’t relevant for many jobs and not something tha... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4684431 Wed, 06 Apr 2011 13:16:41 +0100 4684431 http://www.medworm.com/index.php?rid=4677109&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr0Fv99YQmK0%2F Rise and shine, everyone. Another day is on the way. And it is a sunny one here on the Pharmalot corporate campus, where the short people have left for the local school house and the official Pharmalot mascots are barking at squirrels. You know what this means - it is time for a cup of stimulation. Our flavor today is Southern Pecan. Please join us as we scour the news of the world. Have a great day and do send us those interesting tidbits…. Gilead Raises Prices Of Top-Selling Meds (Dow Jones) J&J Hepatitis C Drug Price Sparks Concern In France (Bloomberg News) Bayer To Consolidate And Add Jobs In New Jersey (The Daily Record) Brand And Generic Makers Clash Over Canada/EU Trade Deal (Pharma Times) Cubist Shares Jump On Teva Patent Deal (Associated Press) Link Sought Between Lab ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4677109 Tue, 05 Apr 2011 12:09:01 +0100 4677109 http://www.medworm.com/index.php?rid=4677113&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOgTzCnzPjBI%2F Five years ago, a study from the US Centers for Disease Control and Prevention staffers linked deaths from widely abused addictive painkillers to an increase of up to 500 percent in the number of prescriptions written. But in the same journal, two researchers from the University of Wisconsin School of Medicine and Public Health disagreed with the conclusions and warned against increased regulation. The article, however, did not disclose their UW Pain & Policy Studies Group already been paid most of the $2.5 million in expected fees from the same drugmakers that make the pills. And these drugmakers, including Purdue Pharma, which sells OxyConting, faced declining sales if regulations were tightened, The Milwaukee Journal Sentinel writes. And so PPSG played a quiet, but significant role... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4677113 Mon, 04 Apr 2011 11:49:51 +0100 4677113 http://www.medworm.com/index.php?rid=4676871&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F04%2F04%2Funderstanding-research-methodology-2-systematic-empiricism%2F Scientific research relies on the use of empirical data for acquiring knowledge.  Empiricism means making use of observation and experience.  Science goes beyond the use of the empiricism normally used in everyday life, however.  Scientific research employs systematic empiricism. Observation itself is necessary in acquiring scientific knowledge, but unstructured observation of the natural world will not lead to an increased understanding of the world. “Write down every observation you make from the time you get up in the morning to the time you go to bed on a given day. When you finish, you will have a great number of facts, but you will not have a greater understanding of the world.” (Stanovich & Stanovich, 2003, p. 12) Empiricism becomes systematic empiricism when it is stru... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4676871 Mon, 04 Apr 2011 09:54:10 +0100 4676871 http://www.medworm.com/index.php?rid=4664473&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCFkCzxDEPE8%2F File this under praying for relief. Several religious groups - including an order of Catholic nuns and a chain of Catholic hospitals - are pressuring a few big drugmakers to exercise some price restraint and have placed proposals that will be voted on during upcoming annual shareholder meetings. Such efforts are not new, but the latest attempt comes after one Wall Street analyst reported that prices for 130 best-selling brand-name drugs rose 6.9 last year, which was the biggest increase in a decade. For instance, a shareholder proposal in the Pfizer proxy from The Sisters of Charity of Saint Elizabeth, which is based in New Jersey, states that the cost of medicines has “skyrocketed in this country in recent years” and the “failure to control costs could undermine the goal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664473 Fri, 01 Apr 2011 12:37:46 +0100 4664473 http://www.medworm.com/index.php?rid=4664477&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0PSQdhxfE7c%2F Several dozen people protested around London earlier today over the ongoing refusal by Johnson & Johnson to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and offering lower prices in poor countries. Unlike several other drugmakers that have agreed to hold talks, Johnson & Johnson’s Tibotec unit has not agreed to negotiate and recently struck a separate licensing deal with several generic drugmakers to make, market and distribute an investigational an HIV med in India, sub-Saharan Africa and Least Developed Countries. The move has been interpreted by some as a way to undermine the MPP initiative (see this). The talks with the other drugmakers, meanwhile, got under way recently... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664477 Thu, 31 Mar 2011 17:11:15 +0100 4664477 http://www.medworm.com/index.php?rid=4658619&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fiz2I6GLsZGY%2F After more than a year of embarassing and debilitating mishaps, Johnson & Johnson is reorganizing its McNeil Consumer Healthcare unit, which has been responsible for the vast majority of the tens of millions of product recalls that led to a consent decree with the FDA (see this). The move, which is expected to be made official on April 4 but was announced internally last month, will transform McNeil into a separate US entity and will be led by Patrick Mutchler, a J&J company group chairman. Meanwhile, the embattled Peter Luther, who has been McNeil president, is taking on a new role - president of US Consumer Healthcare. His replacement at McNeil has not been named. The reorganization follows a difficult year for the health care giant, which experienced a series of manufacturing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658619 Wed, 30 Mar 2011 22:59:40 +0100 4658619 http://www.medworm.com/index.php?rid=4658620&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA5SmUewYtH8%2F After months of anticipation, the Centers for Medicare & Medicaid Services has decided that the Provenge prostate cancer vaccine is eligible for reimbursement. The unsurprising decision comes just four months after a CMS advisory panel voted that Dendreon’s Provenge vaccine for advanced prostate cancer shows “clinically significant” improvement in survival (look here) The panel was convened, however, after the agency last year unexpectedly initiated a so-called National Coverage Determination in response to questions raised by Medicare contractors amid concerns over off-label use. Such a review was unusual, given that Medicare generally pays automatically for FDA-approved oncology meds (read here). For that reason, the CMS review set off a firestorm of protest that the agency wa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658620 Wed, 30 Mar 2011 20:35:23 +0100 4658620 http://www.medworm.com/index.php?rid=4658624&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ft-aVCoVtrjA%2F Hard to believe, but that is the word from Challenger, Gray & Christmas, the outplacement consultants that track monthly changes in each industry. Their latest tally finds that job cuts in the pharmaceutical industry have fallen 87 percent, from 26,165 job cuts a year ago to 3,385 so far this year. This includes 960 planned layoffs announced in March. Consequently, the pharma biz no longer ranks near the top among industries that are laying off gobs and gobs of employees. For most of last year, the pharmaceutical industry had the unpleasant distinction of being the industy sector to consistently shed the largest number of people each month, trailing only the government sector. This time around, pharma did not even make the Challenger top ten (see the rankings here). Of course, jobs a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658624 Wed, 30 Mar 2011 12:52:37 +0100 4658624 http://www.medworm.com/index.php?rid=4658626&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FX_coy97_9ZY%2F Perhaps there is a strategy at work here. Once again, Johnson & Johnson has issued a product recall. In the scheme of things, this is a very modest one - exactly one lot of Tylenol 8-Hour Extended Release Caplets, which amounts to 34,000 150 bottles, according to a statement the health care giant issued yesterday afternoon. Given the overwhelming number of recalls over the past year - tens of millions of products, including over-the-counter meds, hip replacement devices, syringes and contact lenses, among others - perhaps the J&J team has figured out that the public, investors and consumers alike, has tired of hearing about such things and will start ignoring the ongoing problems. Of course, J&J is obligated in some ways to release such info. But the events have become so ro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658626 Wed, 30 Mar 2011 11:56:41 +0100 4658626 http://www.medworm.com/index.php?rid=4653607&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVId4_w7jKkA%2F Yesterday, we wrote that California State Controller John Chiang sent a letter to Gilead Sciences to ask the drugmaker for a reduction in the price of Atripla, a key AIDS med. As it turns out, Chiang actually sent letters to a total of nine drugmakers, asking each of them to lower the prices on their AIDS meds and also extend supplemental agreements that were reached last year to relieve financial pressure on the AIDS Drug Assistance Programs around the country. The other drugmakers he wrote were Abbott Laboratories, Merck, Boehringer Ingelheim, Genentech, Bristol-Myers Squibb, Merck, Johnson & Johnson’s Tibotec unit and ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline. In each case, Chiang wrote that California’s ADAP program has experienced a 257 percent ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653607 Tue, 29 Mar 2011 11:51:03 +0100 4653607 http://www.medworm.com/index.php?rid=4653379&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F29%2Fbest-of-our-blogs-march-29-2011%2F As a dental hygienist, my mom not only cleans people’s teeth, but listens to do them as she does so every day. And like hair stylists and therapists, she often hears their problems too. One of the most valuable advice she has ever given me is to not judge what other people are going through. “You never know what you would do in that situation unless it happened to you.” Our posts this week makes me think about what she said. You may have lived through difficulty, failure, loss of self-respect. You may, in fact, be going through this right now. If so, remember to find the people in your life who won’t judge you, but have compassion for your situation. That person may even be you. I hope you will enjoy our top posts this week! There are some good ones everything from ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4653379 Tue, 29 Mar 2011 11:31:31 +0100 4653379 http://www.medworm.com/index.php?rid=4642995&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuZGC-ukK-wc%2F Should generic drugmakers be required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med? This question goes to the heart of a pair of state lawsuits filed by two women, who claim generic drugmakers should be held liable for failing to warn of serious side effects. However, the drugmakers, which include Actavis and Pliva, claim federal law preempts the lawsuits, because they would be required to offer labeling that is different from what appears on the label of the brand-name drug. The generic drugmakers further maintain that permitting such lawsuits to proceed in state courts would raise their costs, which would, ultimately, be passed on to consumers. This complicated issue will be heard this coming We... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642995 Mon, 28 Mar 2011 13:12:39 +0100 4642995 http://www.medworm.com/index.php?rid=4642996&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWCD_uX1CWRo%2F For the second time in recent months, California State Controller John Chiang has written a drugmaker asking for a reduction in the price of a key AIDS med. This time, Chiang wrote Gilead Sciences to lower the price of its Atripla drug, which costs about $21,900 a year per patient and accounts for about 20 percent of all expenditures made by the AIDS Drug Assistance Programs (ADAP) nationally. The move comes amid shrinking budgets for state ADAP programs (back story) and nearly a dozen states maintain growing waiting lists that, cumulatively, number more than 7,200 people, according to the National Alliance of State & Territorial AIDS Directors (see this). And Chiang maintains California can no longer keep up with rising demand and rising prices, according to his letter. Specifically... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642996 Mon, 28 Mar 2011 13:03:59 +0100 4642996 http://www.medworm.com/index.php?rid=4636661&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuVd-z-wEiP4%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that the Baker & Daniels national lawfirm has elected J. Patrick Fitzsimmons as a lead partner in its life sciences and health care practice group in the Chicago office, effective April 4. For the past six years, he has been associated with var... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636661 Fri, 25 Mar 2011 13:26:16 +0100 4636661 http://www.medworm.com/index.php?rid=4636481&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F25%2Fbest-of-our-blogs-march-25-2011%2F It happened to me the other day. I was admiring a fellow writer’s accomplishment while someone else was admiring my own. The funny thing is that we were both shocked by the compliment. I guess I could dish it, but was surprised that I couldn’t take it. Why is it that we have such an easy time seeing the beauty, hard work and achievement in another, but neglect to see those same things in ourselves? The impact over time of finding the silver lining in our partner’s, friend’s, co-worker’s lives, but focusing on only the shadows of our own lives can make us jealous, bitter, resentful and depressed. It can reinforce negative thoughts and beliefs about what is possible for us instead of motivating us to take risks, play big instead of small and follow our dreams. O... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4636481 Fri, 25 Mar 2011 11:49:38 +0100 4636481 http://www.medworm.com/index.php?rid=4631644&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpUfvhOHHgNA%2F The consent decree process may prove long and tortorous for Johnson & Johnson. Yet another product recall is under way. This time, the beleaguered health care giant is pulling 341 lots of various devices sold by its Ethicon unit for use after surgery, including Blake Silicone Drains and Cardio Connectors. The move came after complaints that the sterile packaging can be compromised. An Ethicon spokeswoman writes us to say that an investigation found that part of the packaging process was not being consistently performed by a contract manufacturer, but that no adverse events have been reported, at least to Ethicon. The 341 lots, by the way, amount to roughly 360,000 individual product units (read more here). For those trying to keep track, well, Johnson & Johnson has recalled tens ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4631644 Thu, 24 Mar 2011 20:01:54 +0100 4631644 http://www.medworm.com/index.php?rid=4627016&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjJLp-JZWBq4%2F The attorneys for Lauren Stevens have succeeded in convincing a federal judge to toss an indictment that charged her with obstructing an FDA probe into off-label marketing of Wellbutrin SR, because federal prosecutors incorrectly portrayed her defense to a grand jury. However, US District Court Judge Roger Titus also ruled the government can seek a new indictment. At the heart of the ruling is her contention that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. Stevens wants to offer what is known as ‘advice of counsel’ defense, although prosecutors argue this should not be permitted, because it might confuse a jury (back story here, here, here and here). In his order, Titus wrote that prosecutors gave &#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627016 Wed, 23 Mar 2011 21:51:54 +0100 4627016 http://www.medworm.com/index.php?rid=4627022&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzsc31rHAVPw%2F A South Carolina state court jury decided late yesterday that a Johnson & Johnson unit violated consumer protection laws by sending doctors a misleading letter in 2003 about the safety and effectiveness of the Risperdal antipsychotic. The jurors also found warning label info was deceptive. And so a judge will now decide whether $360 million in penalties will be paid, Bloomberg News writes. South Carolina argued J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit engaged in “unfair and deceptive acts” by claiming Risperdal was better than competing drugs in the letter, which was sent to some 700,000 doctors nationwide, including 7,200 in the state. The FDA issued J&J a warning letter about false and misleading claims that minimized risks, such as diabetes, and o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627022 Wed, 23 Mar 2011 12:05:21 +0100 4627022 http://www.medworm.com/index.php?rid=4622288&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F22%2Fhow-well-do-you-multitask-between-the-tv-and-the-computer%2F This study hints at the generational shift that is occurring and that researchers are starting to document in studies such as this. Younger adults are used to consuming media simultaneously, from multiple sources, and enjoy doing so. Older adults (that is to say, middle-aged adults and older) do less of this, and tend to enjoy it less. At least according to this single study. Last, the researchers conclude: The brevity of gaze durations on both computer and television content in this multitasking environment suggests a fracturing of attention with rapid attentional shifts and reorientation; both media seem to have limited ability to “hook” a participant into extended runs of attention. Television attention is especially composed of very quick gazes overall, supporting the contention th... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4622288 Tue, 22 Mar 2011 15:25:45 +0100 4622288 http://www.medworm.com/index.php?rid=4622504&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGD7EsfMNbB4%2F In this age of skyrocketing compensation for chief executives and dwindling prospects for drugmakers, there is increasing investor angst that boardrooms are either out of touch, unimaginative or simply indifferent to the protestations that pay packages do not match shareholder interests. The issue has engulfed Johnson & Johnson’s Bill Weldon and, in years past, Dan Vasella at Novartis, for instance. So what to do? Well, pharma boards could start by shifting away from an emphasis on financial measurements - such as EPS, or earnings per share, and EBITDA, or earnings before interest, taxes, depreciation and amortization - to calculate and compare performance, and start focusing on pipeline innovation, according to The Hay Group, a consulting firm that measured ceo pay and incentiv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622504 Tue, 22 Mar 2011 13:40:01 +0100 4622504 http://www.medworm.com/index.php?rid=4615427&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9mVJw9XqOAA%2F For those wondering when Bill Weldon will gracefully relinquish the corner office at Johnson & Johnson headquarters, well, he has no plans to do so until the widespread manufacturing problems are fixed. In an effort to rebut increasing speculation about his departure and criticism of his oversight, he says that he has more work to do and that he will retire when he is good and ready. “That’s, to me, what is first and foremost in my mind,” Weldon tells Bloomberg News in response to questions about the widespread recalls and recent FDA consent decree (see here and here). “People that know me said I’ll fix this problem and, you know, I will fix it.” And the 62-year-old ceo dismisses retirement talk: “It will be the right time (at some point). When it is, I don’t know... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4615427 Mon, 21 Mar 2011 13:16:03 +0100 4615427 http://www.medworm.com/index.php?rid=4611001&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-Fna623g0RI%2F In their ongoing quest to save former GlaxoSmithKline lawyer Lauren Stevens from serving jail time, her attorneys may have succeeded in convincing a federal judge to toss the indictment. Why? They raised doubts about the extent to which federal prosecutors correctly portrayed her defense to a grand jury, according to court documents. And so US District Judge Roger Titus will issue a ruling in which he may instruct the feds to issue a new indictment and begin new grand jury proceedings. You may recall that Stevens, who was indicted for obstructing an FDA probe into off-label marketing of Wellbutrin SR, indicated in recent court filings that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. She wants to offer wha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4611001 Fri, 18 Mar 2011 12:52:00 +0100 4611001 http://www.medworm.com/index.php?rid=4606052&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFiK0SOKwv4Q%2F Where, oh where, did your health care budget go? A larger chunk apparently went to pay for brand-name* prescription meds which, on average, rose 6.9 percent last year. The increase nudged past the 6.8 percent average advance registered in 2008, which was the largest annual jump since Barclays Capital began tracking price hikes, The Wall Street Journal reports. Some of the biggest: the Benicar blood pressure pill sold by Daiichi Sankyo rose 29.3 percent; the Gleevec cancer treatment marketed by Novartis jumped 20.9 percent; Johnson & Johnson’s Concerta pill for ADD moved up 19.7 percent; Pfizer’s Lipitor cholesterol blockbuster popped 12.4 percent, and the Plavix bloodthinner sold by Bristol-Myers Squibb and Sanofi-Aventis rose 13.2 percent. Obviously, drugmakers are &#8220... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4606052 Thu, 17 Mar 2011 12:15:48 +0100 4606052 http://www.medworm.com/index.php?rid=4606053&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM9vyesqva3w%2F Top of the morning to you. A sunny day is unfolding here on the Pharmalot corporate campus where, once again, we are hustling the short people off to the school house. And then we will catch up on reading some interesting documents. What about you? Meetings and deadlines beckon? Of course. To help you along, here are some tidbits from around the world. Have a great day, everyone… Genzyme In Talks To Conduct R&D In Russia (Reuters) UK’s NICE Backs Simponi Rheumatoid Arthritis Med (Dow Jones) CMS Declines To Change Coverage For Anemia Meds (Reuters) ITC To Probe Lilly Infringement Claim (Indianapolis Business Journal) Pfizer Reaches Tax Deal With School District (LoHud) Ireland Plans Pharma Research Center (Irish Independent) CALPERS Ends Talks With Medco (Associated Press) ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4606053 Thu, 17 Mar 2011 11:53:34 +0100 4606053 http://www.medworm.com/index.php?rid=4600794&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbOAeC2w3-i8%2F There are two ways to look at the 2010 compensation package given Johnson & Johnson ceo Bill Weldon. On one hand, the J&J board cut his overall take home by 7 percent, to $28.7 million from $30.8 million, since his performance bonus was slashed - by 45 percent to $1.9 8 million - thanks to all those product recalls and subsequent fallout among some consumers, investors and industry watchers. In other words, he suffered. On the other hand, Bill received a 3 percent merit raise, as noted previously (see here). Whatever your view, the payout reflected a rather dismal year - by most standards - for the venerable health care giant. In addition to congressional hearings; a manufacturing plant that is still closed for retooling; an erosion of consumer trust; $900 million in lost sales; ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600794 Wed, 16 Mar 2011 15:54:20 +0100 4600794 http://www.medworm.com/index.php?rid=4592687&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9rpO-uUxuso%2F Less than two weeks after closing the deal to buy King Pharmaceuticals, Pfizer is now voluntarily recalling all dosages and lots of the Embeda painkiller due to stability requirements that were not met during routine testing. And the problem may take several months to resolve. The move, which was disclosed in a statement today on the Embeda web site, is a blow to the drugmaker, which spent $3.6 billion to add a pain franchise to its withering portfolio of prescription medicines (back story). Embeda is not yet a huge seller, having notched $67 million in revenue last year. “It’s not good news, but it’s not meaningful” at that level of sales, says Deutsche Bank analyst Barbara Ryan. Nonetheless, Embeda has been viewed as a drug with potential, because it was the first... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592687 Tue, 15 Mar 2011 20:42:47 +0100 4592687 http://www.medworm.com/index.php?rid=4592689&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUdLb4vh7Hrs%2F What if a pharma exec was supposed to be sentenced for a misdemeanor but, due to a change in sentencing guidelines, was instead going to receive a harsher sentence usually meted out for felonies? Depending upon your station in life, this may be a good thing or a bad thing. If you happen to be the exec, however, this is probably not a good thing. But if a recent proposal goes into effect, well… tough luck. What are we talking about? Two months ago, the US Sentencing Commission issued a proposal to amend the sentencing guidelines that would impose tougher punishments for anyone convicted of so-called strict liability offenses under the Food, Drug & Cosmetic Act (look here). In legal lingo, the difference is between between following the 2B guidelines for fraud instead of the curre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592689 Tue, 15 Mar 2011 12:15:58 +0100 4592689 http://www.medworm.com/index.php?rid=4592690&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXgxfoXXmECM%2F How has Medicare been spending taxpayer dollars these last few years? What would you say if the federally funded health care program dished out more than $3.1 million to buy Pfizer’s Viagra and other impotence pills for seniors? Well, that’s what happened in 2007 and 2008, according to a new report from the US Department of Health & Human Services Office of the Inspector General. As you might imagine, this was not supposed to happen. Medicare “should not have covered these drugs,” George Reeb, acting deputy inspector general for audit services at the HHS wrote in a report released yesterday. And he recommended that the Centers for Medicare & Medicaid Services work with the FDA to maintain and distribute a list of prohibited drugs. But what went wrong? The CMS bra... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592690 Tue, 15 Mar 2011 12:15:46 +0100 4592690 http://www.medworm.com/index.php?rid=4592692&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiuCK9gVcHX0%2F A former sales director for Exactech, a device maker based in Florida, was sentenced yesterday by a federal judge to five years of probation and ordered to pay $56,000 after pleading guilty to setting up a kickback scheme with orthopedic surgeons. As part of a plea deal struck last December, he also agreed to make restitution for losses attributed to the scheme – specifically, a $50,000 bonus. Donald Donofrio, who worked at Exactech from 2002 through 2008, admitted to conspiring to induce surgeons to use and purchase hip and knee replacement and reconstructive devices. And he admitted to fraudulently inflating entries in work reports used to justify payments to these docs under consulting agreements with Exactech. The sentencing comes as the US Department of Human & Health Services ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592692 Tue, 15 Mar 2011 12:14:10 +0100 4592692 http://www.medworm.com/index.php?rid=4592695&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQzD6otG0mCU%2F One of the big gripes among biotech investors is that Amgen has refused to pay a dividend. No matter how many times the issue has been raised, execs have refused to consider the prospect. Never mind that the stock has been battered amid a raft of struggles, notably FDA warnings over health risks associated with the Aranesp and Epogen anemia meds, concerns about reduced Medicare reimbursement and uncertainty about its pipeline and acquisition strategy (see this). At one point, the combination of setbacks and miscues resulted in Kevin Sharer being named one of the worst chief executives a few years ago (see this). Now, though, attention is focused on the possibility of a dividend since Wall Street anticipates the issue will be addressed at the upcoming annual shareholder meeting. Investors, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592695 Mon, 14 Mar 2011 13:59:30 +0100 4592695 http://www.medworm.com/index.php?rid=4575244&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyX0B1GekJDo%2F Earlier this week, we wrote how the European Association for the Study of the Liver had difficulty maintaining an embargo on abstracts to be reviewed at its upcoming annual conference, even though the material is freely available on the Internet (see here). Then Embargo Watch notes that the public relations firm for the EASL is Cohn & Wolfe, which also represents various drugmakers, such as Allergan, Genzyme, Sanofi-Aventis, Boehringer-Ingelheim and Merck (see this). This raises a question: how can a public relations firm equitably run the media operations for a professional society conference and simultaneously represent drugmakers who may have a great deal at stake at these conferences? You know, abstracts from one or more clients could be on display at the gathering. How can the EA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575244 Fri, 11 Mar 2011 16:36:35 +0100 4575244 http://www.medworm.com/index.php?rid=4575098&cid=t_102041_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F11%2Fbest-of-our-blogs-march-11-2011%2F I have a confession to make. Last year, I did something crazy and unlike me. I participated in a comedy show called Penn & Teller’s Bullshit on Showtime. For someone as introverted as I am, it was one of the most scariest and embarrassing things I ever did. It’s not something I am especially excited to share. But I’m doing so for a reason. The subject of the show was affirmations. It questioned whether there was anything really beneficial to it or just another laughable practice best turned into a parody on Saturday Night Live. You know like Stuart Smalley’s, “Daily Affirmations?” Surprisingly, it’s not all, “I’m good enough, I’m smart enough, and doggone it people like me.” There are actually real benefits to affirmatio... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4575098 Fri, 11 Mar 2011 10:37:29 +0100 4575098 http://www.medworm.com/index.php?rid=4570755&cid=t_102041_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdawHSkf9zpU%2F After months of serious manufacturing problems, Johnson & Johnson has entered into a consent decree with the FDA for three separate facilities that have been responsible for most product recalls over the past year. Moreover, two execs - McNeil Consumer Healthcare vp of quality Veronica Cruz and the vp of operations for OTC products, Hakan Erdemir - were also named as civil defendants. The plants, all of which are run by the McNeil Consumer Healthcare unit, are located in Fort Washington and Lancaster, Pennsylvania, and Las Piedras, Puerto Rico. As part of the decree, which is expected to run five years, J&J is required to destroy all drugs made at the facilities since 2009, J&J must hire outside experts to develop remediation plans and follow strict timetables for meeting va... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570755 Thu, 10 Mar 2011 21:06:51 +0100 4570755