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 'contract'. Sat, 03 Sep 2011 02:04:15 +0100 http://www.medworm.com/index.php?rid=5182320&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FscEadyD2R4s%2F As technology makes the world smaller, monitoring clinical trials no longer requires traveling to a destination to check up on the investigators. Much of this work can be done remotely and the FDA, in fact, wants to encourage sponsors to undertake more of what the agency calls risk-based monitoring in order to match international standards articulated by the International Conference on Harmonisation. And so the agency has just issued new guidance for drugmakers and contract research organizations, or CROs, to help sort out the variables that would determine when centralized monitoring would be preferable over on-site monitoring. The primary focus, the FDA notes, should be on steps that protect human subjects, while maintaining data integrity and compliance with regulations. Despite advance... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182320 Thu, 01 Sep 2011 14:50:37 +0100 5182320 http://www.medworm.com/index.php?rid=5182323&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMmVEzuXRy0%2F Top of the morning to you. And yet another shiny day is unfolding over the Pharmalot corporate campus, where the short people and the official mascots appear to be snoozing indefinitely. This rare treat gives us more time this morning to brew those mandatory cups of stimulation and poke around for interesting items. So here they are. Meanwhile, we will get back to conducting our own version of R&D. So keep us in mind if you hear something interesting. Have a great day… Sanofi Strikes Deal To Make Generic Lipitor (Reuters) FDA And Drugmakers Agree On 6 Percent PDUFA Fee Hike (Wall Street Journal) XOMA CEO Resigns (Reuters) Baxter Sues Teva To Enforce Propofol Liability (Bloomberg News) Death Rate Rises In Clinical Trials In India (The Tribune) Contract Pharmaceuticals To Lay Off ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182323 Thu, 01 Sep 2011 12:08:48 +0100 5182323 http://www.medworm.com/index.php?rid=5130650&cid=t_155145_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F08%2F15%2Fcommissioning-healthier-catering-and-hospitality-investing-in-a-healthy-workforce-%25e2%2580%2593-guidance-to-help-specify-healthier-catering-and-hospitality%2F Title: Commissioning healthier catering and hospitality: Investing in a healthy workforce – guidance to help specify healthier catering and hospitality Click or scan to download Commissioning healthier catering and hospitality: Investing in a healthy workforce - guidance to help specify healthier catering and hospitality The Skinny: Report from the North West Food & Health Taskforce that offers guidance in specifying healthier catering and hospitality with in the NHS. It also considers issues of sustainability and fair trade. Publisher: North West Food & Health Taskforce Published: March 2006 Size: 136p. Published: May 2011 Filed under: Ooops Missed Category! Tagged: Balanced diet, Catering, Commissioning, Contract catering, Food preparation, Food purchasing, Grey Literature,... Fade Library blogs http://www.medworm.com/rss/comments.php?id=5130650 Mon, 15 Aug 2011 14:57:43 +0100 5130650 http://www.medworm.com/index.php?rid=5118994&cid=t_155145_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=5086557&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9bdN0mPFRfU%2F Last week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. In explaining its move, the agency maintained there were “significant instances” of misconduct. The agency says Cetero failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and did not take sufficient steps to assure data integrity during those five years. And so drugmakers must check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications - and may have to repeat or confirm results (back story). For its ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086557 Mon, 01 Aug 2011 13:30:19 +0100 5086557 http://www.medworm.com/index.php?rid=5069821&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FixYMOtPCKNc%2F THIS POST RAN LAST NIGHT, BUT FOR THOSE WHO DID NOT KNOW… This is every drugmaker’s nightmare. The pharmaceutical industry has been put on alert by the FDA that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. There were “significant instances” of misconduct, the FDA says. “This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also,” according to the auditor. The FDA adds that Cetero also failed to conduct an adequate internal investigation to determine the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069821 Wed, 27 Jul 2011 11:42:35 +0100 5069821 http://www.medworm.com/index.php?rid=5069825&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRqwvmj9MSCs%2F As drugmakers scramble to replenish their pipelines, they are encountering all sorts of difficulties, including rising costs for clinical trials. And this is happening across all phases. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey. And so, 32 percent of those surveyed pointed to higher costs for enrolling patients and 25 percent cited vendor fees. Expenses for recruiting trial sites was named by 14 percent, followed by 12 percent who fingered technology costs, according to Cutting Edge Information, which surveyed 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations. Meanwhile, staffing for drug development is rising. For instance, Phase IV ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069825 Tue, 26 Jul 2011 14:39:41 +0100 5069825 http://www.medworm.com/index.php?rid=5050534&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FzE5hTHeZnEM%2F The American welfare state has been in crisis for decades. Many of the problems faced in 1995 fight have become less tractable problems today. John Samples comments in yesterday’s Cato Daily Podcast. One notable difference between 1995 and today, Samples says, is that the GOP of 1995 kept Social Security off the chopping block for spending cuts. Subscribe to the podcast here (RSS) and here (iTunes). Parallels to 1995 in Spending Fight is a post from Cato @ Liberty - Cato Institute Blog (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5050534 Wed, 20 Jul 2011 12:44:31 +0100 5050534 http://www.medworm.com/index.php?rid=4968583&cid=t_155145_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F06%2F23%2Fwhen-things-go-wrong-in-massachusetts-fire-the-employees-not-carney-hospital%2F Mental health care in Massachusetts is sometimes a hit or miss proposition. Especially if you’re poor or indigent, or may present a danger to yourself or others. For the 14-bed locked hospital unit at Carney — now owned by Steward Health Care — it apparently was such a “miss” proposition that they ended up sacking the entire staff. Yes, you heard me — all 29 psychiatric nurses and mental health counselors were let go about a month ago. Meanwhile, Massachusetts continues to pay Carney Hospital to run its program, with all new staff. Is it possible that 29 different professionals really were responsible for the four complaints? Or is this a perfect example of incompetent management and senior hospital executives covering their asses, and trying to put the ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4968583 Thu, 23 Jun 2011 14:39:20 +0100 4968583 http://www.medworm.com/index.php?rid=4893914&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FS1JlIDgJ9No%2F File this under failing the test. A doctor and a clinical research coordinator working for a contract research organization hired by the former Schering-Plough were indicted by the feds for falsifying study data. The clinical trial was designed to test a tablet the drugmaker was developing to treat allergies. Wayne Spencer, 73, a licensed physician and the principal investigator, and Lisa Sharp, 48, the clinical director of clinical trials at Lee Research Institute, were charged with one count of conspiracy, three counts of mail fraud, and one count of falsifying information required by the FDA. The crimes are alleged to have occurred from January 2010 to May 2010. The study was to have enrolled patients at least 50 years who suffer from ragweed-induced allergy symptoms. Employees at the C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893914 Fri, 03 Jun 2011 12:34:02 +0100 4893914 http://www.medworm.com/index.php?rid=4813326&cid=t_155145_97_f&fid=35606&url=http%3A%2F%2Fwww.theangriestpharmacist.com%2F2011%2F05%2F10%2Fthe-crap-people-send-me%2F I got the following email from "Pat" concerning a "pain contrtact." One side of me wants to say, you're an addict and you need help from a few different doctors. One side of me wants to say this poor woman's pain is being under treated by her physician. Still yet, one side, the prevailing side, doesn't give a flying f.. I present this email for your amusement. Readers, please tell her what you think. I get so many emails/contact notes from folks like this, that I no longer take the time to respond. It is up to this community to cull its nuts.   From: pat <d********y@yahoo.com> Subject: Pain Contrtact Title: Technician Message Body: Dear Sir, it is with deep shame, and not a little fear, that I compose this message. I'm a woman in her late thirties, and I'm a Pharmacy Tech. I als... The Angriest Pharmacist blogs http://www.medworm.com/rss/comments.php?id=4813326 Wed, 11 May 2011 04:04:04 +0100 4813326 http://www.medworm.com/index.php?rid=4789642&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKd3ujMNjWQI%2F A shift among drugmakers to prefer existing patients, rather than healthy volunteers, for early stage trials, is forcing Parexel, one of the largest contract research organizations, to close offices and eliminate jobs. Specifically, the CRO is cutting up to 30 per cent of Phase I capacity and around 300 jobs, or about 3 per cent of its 10,350 workforce, according to a filing with the Securities and Exchange Commission. Other factors are at work, though. The CRO acknowledged that some clients delayed the start of large projects, underscoring the weakness of the pharmaceutical pipeline. Meanwhile, as Outsourcing Pharma points out, Parexel execs believe the shift away from trials in healthy volunteers is permanent, or at least demand will be lower for the foreseeable future. “We believ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789642 Wed, 04 May 2011 12:09:52 +0100 4789642 http://www.medworm.com/index.php?rid=4753973&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6I6iFNkZiNw%2F Hello, everyone. Another shiny day is unfolding on the Pharmalot corporate campus, where we have successfully begun hustling the short people off to the local school house. As for us, we have a busy day planned since we will host a webinar later about pharma ad agencies and procurement issues (look here). Meanwhile, here are some tidbits to get you started. Hope today is a productive one and see you soon… Merck Hep C Drug Boosted Cure Rates In Trials: FDA (Bloomberg News) Abbott Trilipix & Statin Combo Can Cause Heart Problems: FDA (Reuters) Painkillers Make Antidepressants Less Effective: Study (The Globe & Mail) Cardinal Health Pays $8M To Settle Kickback Claims (Kansas City Business Journal) Mitsui Buys CMO Operations In China (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753973 Tue, 26 Apr 2011 12:03:01 +0100 4753973 http://www.medworm.com/index.php?rid=4704957&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTqt7VZfCzXA%2F For those who had any doubt about where R&D money is headed…look east. As in the Far East. A recent survey of 241 execs from drugmakers and biotechs finds that R&D budgets are rising just 1 percent overall this year. Meanwhile, outsourcing is expected to rise 11 percent, to 41 percent of the R&D undertaken, and most companies favor investing more of their clinical work in China. There is a price to pay, though. In the three-month period prior to the survey, price increases by contract research organizations outnumbered decreases by a 5-to-1 ratio. Looked at another way, 35 percent of the drugmakers and biotechs reported a price hike from CROs, compared with 6 percent that reported a price drop, according to the survey by RW Baird, the Wall Street brokerage. “We ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704957 Tue, 12 Apr 2011 12:08:46 +0100 4704957 http://www.medworm.com/index.php?rid=4512617&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3sAMB9LDD1o%2F Rise and shine, everyone. Another day is on the way. And as usual, we are preparing by quaffing the mandatory cup of stimulation - our flavor today is Golden French Toast. We would also like to remind your that we are hosting a webinar on requirements for disclosing payments to physicians (please look here). Meanwhile, here are a few items of interest to help you on your way. We hope today is productive and you achieve your goals. Have a good one… Texas AG Wants Actos Marketing Documents From Lilly (Dow Jones) US Protests Canadian Drugmaker Insolvency Case (Dow Jones) Vertex Reports Significant Data For Cystic Fibrosis Drug (The Street) India Begins Review Of Foreign Takeovers Of Drugmakers (Economic Times) Takeda Pulls Pain Drug That Is Now Called Useless (Japan Times) CMO Consolida... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512617 Wed, 23 Feb 2011 12:48:46 +0100 4512617 http://www.medworm.com/index.php?rid=4386344&cid=t_155145_123_f&fid=39036&url=http%3A%2F%2Fpediatricinc.wordpress.com%2F2011%2F01%2F22%2Fare-pediatricians-all-going-poor-because-they-can%25e2%2580%2599t-negotiate-with-mco%25e2%2580%2599s%2F By Chip Hart & Brandon Betancourt by dmason I always find it amusing when parents call our office suggesting that their kids got sick as a result of coming to our office. “…we came in with little Timmy for his 12-month check-up and he was fine. The next day, he was crabby, with a cough and runny nose. I think he got sick while waiting in your waiting room!” “Oh, yes, you were the couple that came in with Timmy in that sterile bubble and you only took him out once you got here… I remember now.” “What’s that?” “Nah! They clean those toys so well at the daycare; I doubt germs got passed from kid to kid either.” I don’t actually respond like that (out loud), but I wish I could. Funny thing is that pediatricians, and those that work for them, often do the same as par... Pediatric Inc blogs http://www.medworm.com/rss/comments.php?id=4386344 Sat, 22 Jan 2011 11:00:39 +0100 4386344 http://www.medworm.com/index.php?rid=4225373&cid=t_155145_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F12%2F02%2F5-tips-for-a-low-stress-customer-service-experience%2F “Thank you for calling customer service! My name is Summer. How can I help you?” Wait, it’s after 5 pm. And this is the internet, not a phone. And I’m at my kitchen table, not in my drab fabric-walled cubicle. And I’m not wearing a headset. Let me switch hats for a moment and return to being a writer for the next few minutes. Tomorrow, I celebrate my last day of working in a customer service call center. (Despite the rumors, it’s not an easy gig.) Over the past few years, I’ve been called some less-than-savory names through the phone lines. A few customers have threatened me. Even more have called me a liar, played psychological games with me, and screamed words that their grandmothers would be ashamed to hear. Lesson learned: contacting a customer... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4225373 Thu, 02 Dec 2010 16:57:02 +0100 4225373 http://www.medworm.com/index.php?rid=4220453&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk9WbnQqs8I8%2F The parade of sales reps being dismissed by drugmakers grows every few weeks. Just yesterday, Novartis acknowledged what it recently tried to deny about eliminating 1,400 sales reps and, last month, Roche disclosed plans to eliminate 4,800 jobs, some of which will be replaced by outside sales to market the Tamiflu med. Of course, still more layoffs are expected. So we chatted with Nancy Lurker, a former Novartis senior vp and chief marketing officer, who now runs PDI, one of the faster growing contract sales organizations, for some insights… Pharmalot: So how bad is out there right now for sales reps? Lurker: It’s pretty significant. The layoffs continue. There’s still another major pharma that I know of that may announce some downsizing before the end of the year. It’s just very ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220453 Wed, 01 Dec 2010 16:09:18 +0100 4220453 http://www.medworm.com/index.php?rid=4214486&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FytaYMSbbu9s%2F Rise and shine, everyone. Another day is on the way. And here on the busy Pharmalot corporate campus, we have already fed the official mascots, hustled one of the short people off to the local school house and brewed a cup of stimulation. What next? Documents to read, phone calls to return and the never-ending search for new ideas. While we get started, here are some tidbits to help you jumpstart your own routine. Have a good one and stay in touch… More Clinical Trials Are Being Held In India (The Times of India) BRIC CRO’s Are Getting More Business (Outsourcing Pharma) UK ‘Patent Box’ Will Create New Jobs (Pharma Times) AstraZeneca Cancer Drug Linked To Toxicity (Wall Street Journal) Mom Vows Fight Against Sanofi Despite Setback (News & Star) The Generic Threa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4214486 Tue, 30 Nov 2010 12:58:50 +0100 4214486 http://www.medworm.com/index.php?rid=4082161&cid=t_155145_113_f&fid=34634&url=http%3A%2F%2Fwww.emrandhipaa.com%2Femr-and-hipaa%2F2010%2F10%2F15%2Femr-vendor-extortion-for-renewal-fees%2F A reader of EMR and HIPAA recently emailed me about the title of this post. The way they saw it, the software renewals fees for an existing EMR user amounted to EMR vendor extortion. This person felt like providers had little options when it came to the renewal fees that EMR vendors would charge them. The fact of the matter is that it’s not actually extortion (from what I’ve seen), but it certainly can feel that way if you’re a provider that’s getting charge a train load of money to renew or update your license with your EMR vendor. Unfortunately, once you’re in that position you really don’t have many options. Plus, your options are always very specific to the contract you signed with the EMR vendor. Instead of focusing on those who are stuck with littl... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=4082161 Fri, 15 Oct 2010 15:52:45 +0100 4082161 http://www.medworm.com/index.php?rid=4013258&cid=t_155145_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F09%2F29%2Ffraser-kirk-and-adjustment-disorders%2F In Australia, David Jones’ publicist Kristy Fraser-Kirk is suing the company she works for and its former CEO Mark McInnes for sexual harassment. David Jones is sort of like Macy’s, except it’s based in Australia. According to news reports, Ms. Fraser-Kirk, 27, is suing David Jones, Mark McInnes and nine directors of the company. She is seeking compensation for a number of different claims, including breach of contract, as well as punitive damages of $37 million. Not exactly chump change. But then again, maybe that’s what it takes to send a clear message about how sexual harassment will not be tolerated in the modern workplace. But due to the publicity surrounding the case in Australia, she’s now making a new novel claim — that the publicity has led to a... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4013258 Wed, 29 Sep 2010 10:20:49 +0100 4013258 http://www.medworm.com/index.php?rid=3845282&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4xi4_YanGhk%2F As promised, the US Justice Department - along with the US Securities and Exchange Commission - is paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). In recent months, at least five big drugmakers have received letters as the federal government seeks to uncover any violations of the Foreign Corrupt Practices Act, which forbids US companies from bribing foreign government officials. Among those that have been contacted in recent months concerning their activities are AstraZeneca, Bristol-Myers Squibb, Baxter, Eli Lilly and Merck (see page 26 here). An AstraZeneca spokesman says the drugmaker is cooperating. A Lilly spokesman notes the drugmaker, which was the subject of a 2003 probe of its Polish subsidiaries, is also cooperatin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845282 Mon, 09 Aug 2010 13:12:04 +0100 3845282 http://www.medworm.com/index.php?rid=3798547&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FdN1uWxMDQLE%2F By Ilya ShapiroIn an apparent attempt to simultaneously slander the Tea Party movement and preempt some of the themes the Republican Party will run on come Labor Day, the Democratic National Committee is announcing today the “Republican Tea Party Contract on America.”  Echoing Newt Gingrich’s 1994 “Contract with America,” the faux manifesto contains the following ten points: Repeal the Affordable Care Act (Health Care Reform) Privatize Social Security (or phase it out altogether) End Medicare as it presently exists Extend the Bush tax breaks for the wealthy and big oil Repeal Wall Street Reform Protect those responsible for the oil spill and future environmental catastrophes Abolish the Department of Education Abolish the Department of Energy Abolish the E... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3798547 Wed, 28 Jul 2010 14:22:34 +0100 3798547 http://www.medworm.com/index.php?rid=3750277&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJRV_5GQ4Oyc%2F Hello, everyone. Nice to see you again. Hope your week is going well so far. Meanwhile, another busy day lies ahead, especially as the FDA panel meeting gets under way to review Avandia. So let’s get started with a cup of stimulation and some interesting tidbits to help you along. Have a good one and stay in touch… Vivus Diet Drug Faces FDA Skepticism (Associated Press) Merck Starts Work On New Plant In China (People’s Daily) Lawsuits May Reveal More Avandia Data (Reuters) Lilly To Cut 170 Manufacturing Jobs (Indianapolis Business Journal) Global CSO Market To Hit $6.5B By 2015 (OutsourcingPharma) Clinuvel Drug Offers Relief From Sensititivity To Light (Bloomberg News) Latisse Faces Patent Challenge (The Wall Street Journal) Bristol-Myers Starts Recall Of Coumadin (Assoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750277 Tue, 13 Jul 2010 12:03:03 +0100 3750277 http://www.medworm.com/index.php?rid=3710560&cid=t_155145_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Funiversity-hospitals-and-the-3-for-1-doctor-swap%2F2010.06.29 As doctors increasingly become physician-employees, there’s no longer a need to share resources with university specialists: Three University of Virginia cardiologists have been told by the Augusta Health board they will lose their hospital privileges next week, impacting the 2,500 patients the doctors serve. Augusta Health officials [Crow] told the doctors in a letter that they won’t be able to treat their patients in emergencies or otherwise at the hospital in Fishersville. Crow’s statement said the board is limiting cardiology department participation to doctors “under contract to Augusta Health.” Augusta Health has four cardiologists on staff, and will soon have a fifth, he said. Limiting cardiology participation to the hospital’s own doctors will allow Augusta Health �... Better Health blogs http://www.medworm.com/rss/comments.php?id=3710560 Tue, 29 Jun 2010 15:00:00 +0100 3710560 http://www.medworm.com/index.php?rid=3662923&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKdZRJttSLac%2F In a bid to strengthen safety and project a tougher image, the FDA may soon require drugmakers to conduct on-site audits at manufacturing facilities run by outside contractors, The Wall Street Journal reports. Right now, drugmakers may review data about quality control and product testing, but this new requirement is all about doing a hands-on inspection. The move comes following the Heparin scandal and increasing use of contract manufacturing operations in far-flung locales where costs are lower but supervision may be minimal. However, the effort would also include contractors in the US. In taking such a step. The plan was discussed at a recent conference at Xavier University’s Med-Xu by FDA consumer safety officer Brian Hasselbalch. The FDA would put more onus on drugmakers to vou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3662923 Tue, 15 Jun 2010 14:08:33 +0100 3662923 http://www.medworm.com/index.php?rid=3635729&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F1s97jqEG2e4%2F By Jim HarperThe Contract From America is a very interesting political document, seeking to rally people around a set of policies that—unlike the Contract With America from years ago—was generated from the bottom up. On the WashingtonWatch.com blog, I’ve been assessing the ten items in the Contract From America. The Tea Party movement stands for a lot of ideas in a lot of people’s minds. Here’s a chance to see what substantive policies are important to a large cross-section of this political movement. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3635729 Sun, 06 Jun 2010 19:24:05 +0100 3635729 http://www.medworm.com/index.php?rid=3625483&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FbfLoyX4p_9I%2F By Walter OlsonAs recent posts in this space indicate, advocates of individual liberty have a variety of views on the proper policy response to illegal immigration. Whatever the disagreements, I suspect there’s some degree of consensus that certain proposed remedies are entirely too Draconian. From the California Labor and Employment Law Blog: The U.S. Attorneys Office in San Diego has recently criminally prosecuted a French bakery for allegedly engaging in an intentional pattern and practice of hiring unauthorized workers. As part of the indictment, the Government is seeking hefty monetary fines, prison time for the owner and management, and asset forfeiture of the entire business to the Government. While the Government does not have experience running a French bakery, they are gett... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3625483 Wed, 02 Jun 2010 18:28:30 +0100 3625483 http://www.medworm.com/index.php?rid=3610370&cid=t_155145_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F05%2F29%2F8-ways-to-overcome-jealousy-and-envy-2%2F I know that the fastest way to despair is by comparing one’s insides with another’s outsides, and that Max Ehrmann, the author of the classic poem “Desiderata,” was absolutely correct when he said that if you compare yourself with others you become either vain or bitter. Or, as Helen Keller put it: “Instead of comparing our lot with that of those who are more fortunate than we are, we should compare it with the lot of the great majority of our fellow men. It then appears that we are among the privileged.” But Helen and Max don’t keep me from going to the land of comparisons and envy. Before long, I’m salivating over someone else’s book contract, or blog traffic numbers, or “Today Show” appearance. Then I have to pull out my ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3610370 Sat, 29 May 2010 13:18:01 +0100 3610370 http://www.medworm.com/index.php?rid=3592409&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9tRmMfqC4sQ%2F Welcome back, everyone. We hope your weekend was pleasant and restful. Now, of course, the routine returns. As always, we are brewing the mandatory cup of stimulation as we map out the week ahead. With meetings and deadlines looming, here are a few items to keep you abreast of events. Hope the days goes well and do stay in touch… Pfizer Gave Union ‘False Hope’ About Facility (The News-Journal) Pharmacists Want Compensation From Glaxo (Stuff.co.nz) Quintiles Lays Off No. Carolina Employees (Triangle Business Journal) ASCO Briefing Highlights Promising Data (PharmaTimes) Contract Pharmaceutical Closing NY Plant, Axing 260 Jobs (Associated Press) WHO Says EU Drug Seizures Were Improper (The Hindu) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3592409 Mon, 24 May 2010 11:53:08 +0100 3592409 http://www.medworm.com/index.php?rid=3545537&cid=t_155145_123_f&fid=39036&url=http%3A%2F%2Fpediatricinc.wordpress.com%2F2010%2F05%2F08%2Fpediatric-practice-management-conference%2F Discussion How to get Government Funding for EHR How to be Successful in a Tough Economy Top Ten Legal Issues Practices Need to Know Negotiating in the New World of Managed Care Coding 2010: Modifying, Documenting, and Getting Paid Coding Tips and Billing Strategies For Getting Paid What You Deserve The Silents, Boomers, GenXers and GenYers: Managing the Generations and more! To check out the course schedule, click on this link For more information about the conference check out this link I attended last year’s conference and it was completely worth it. What I loved most about the conference, is that it is pediatric specific. There is a big difference in a conference that focuses on multiple medical specialties (like the MGMA for example), and a conference that makes pediatric practic... Pediatric Inc blogs http://www.medworm.com/rss/comments.php?id=3545537 Sat, 08 May 2010 15:00:15 +0100 3545537 http://www.medworm.com/index.php?rid=3505136&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fvq3oMKtlz6o%2F Industry expansion in China continues unabated as Charles River Laboratories agreed to buy WuXi Pharma Tech, a Chinese outsourcing services firm. The deal would apparently be the largest foreign takeover of a Chinese company and, significantly, would give Charles River testing facilities in Shanghai, Suzhou and Tianjin in China, where labor and laboratory costs are cheaper (see statement). Overall, the CRO market in China is growing up to 30 percent a year, according to Jinsong Du, an analyst in Hong Kong at Credit Suisse. “This is a vote of confidence that China will be the main location for drug R&D outsourcing in the future,” he tells Bloomberg News, adding that Charles River gets to eliminate a potential competitor in the process. Du also notes Charles River gets a “very... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3505136 Mon, 26 Apr 2010 12:23:52 +0100 3505136 http://www.medworm.com/index.php?rid=3307092&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqYuzAc_GZ4g%2F Hello, everyone. Have your shovel ready? Once again, a big storm is descending on the Pharmalot corporate campus and other parts of the Northeast. Nonetheless, we are not deterred. There is much to do. So here are a few items to help you keep focused. Dig in and, then, dig out… Mylan Labs Posts Higher Profit (Associated Press) Anadys Hep C Drugs Shows Early 73 Percent Response (Reuters) Pfizer Wins Prempro Lawsuit (Philadelphia Inquirer) Biotechs Turn To US CMOs (OutsourcingPharma) Pfizer Osteoporosis Drug Gets Lukewarm Review (Reuters) FDA OKs Pfizer’s Prevnar 13 Vaccine (Associated Press) Shire Gets Fast-Track Status For Replagal (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3307092 Thu, 25 Feb 2010 13:03:01 +0100 3307092 http://www.medworm.com/index.php?rid=3283493&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F02%2Fquintiles-to-more-heavily-directly.html This article included an interview with a single apparently academic expert who provided reassurance that the conflicts of interest discussed in the article were not really so worrisome.  This expert, however, failed to disclose his own extensive, albeit somewhat indirect ties to a variety of corporations that might benefit from the conflicts discussed as the main topic of the article, including corporations that were directly involved in them (Quintiles and Eli Lilly).  Maybe because the reporter thought that the expert was unbiased, there was no attempt to find a contrasting opinion.So I say again, again, again, health care professionals, policy  makers, and people in general need to be extremely skeptical of most of the apparently unbiased pronouncements made about medica... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3283493 Wed, 17 Feb 2010 17:22:00 +0100 3283493 http://www.medworm.com/index.php?rid=3167090&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F6hNK1oMEAhA%2F By Daniel IkensonWhy blame only media and politicians for the public’s confusion about imports and trade deficits? Surely economists deserve some scorn. Some of the misunderstanding can be traced to the famous National Income Identity, which expresses gross domestic product, as: Y = C + G + I + (X-M). That is, national output (Y) equals personal consumption (C) plus government spending (G) plus investment (I) plus exports (X) minus imports (M). The expression clearly lends itself to the wrong interpretation. The minus sign preceding imports suggests a negative relationship with output. It is the reason for the oft-repeated fallacy that imports are a drag on growth. Here’s why that conclusion is wrong. The expression is an accounting identity, which “accounts” for all of the... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3167090 Wed, 13 Jan 2010 15:03:39 +0100 3167090 http://www.medworm.com/index.php?rid=3149033&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FDm_nrwtWRKc%2F By Jason KuznickiThe most interesting libertarian-related conversation I’ve read today comes from Rortybomb, by way of Andrew Sullivan, with commentary by Megan McArdle. Here’s a challenge to libertarians from Rortybomb, aka Mike Konczal: I want to pitch to the credit card and financial industry a new innovative online survey. It is targeted for older, more mature long-time users of our services. We’ll give a $10 credit for anyone who completes it. Here is a sense of what the questions will look like: - 1) What is your age? - 2) What day of the week are you taking this survey? - 3) Many rewards offered are for people with more active lifestyles: vacations, flights, hotels, rental cars. Do you find that your rewards programs aren’t well suited for your lifestyle? - 4) What i... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3149033 Wed, 06 Jan 2010 19:36:45 +0100 3149033 http://www.medworm.com/index.php?rid=3026905&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F537xBMO1vWw%2F ‘Tis the middle of the week, but this is a short one in the US due to the Thanksgiving holiday. What will you be doing? At our place, Mrs. Pharmalot has graciously volunteered to cook a few birds (we opted for duck and cornish hen this year) and we are celebrating the long weekend with two more installments of our ‘Let’s-See-Them-Before-They-Die’ concert series (see here and here). Meanwhile, though, there is work to be done. So once again, we have gathered a few items of interest. Have a nice day everyone and enjoy… Novartis Strikes Licensing Deal With Incyte (Reuters) Contract Manufacturing Market To Hit $34B By 2014 (OutsourcingPharma) Bristol-Myers Won’t Take Tax Hit For Mead Johnson Split (CFO.com) Pfizer To Expand R&D In China (Reuters) Roche See... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3026905 Wed, 25 Nov 2009 13:24:16 +0100 3026905 http://www.medworm.com/index.php?rid=2871565&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FQVk6Rjg9WV4%2F I was glad to see James Pinkerton engage my criticism of Louisiana Gov. Bobby Jindal’s (R) endorsement of federal price controls for health insurance.  I was even more pleased to see that Pinkerton has his own blog devoted to developing a Serious Medicine Strategy. If I understand Pinkerton, his argument is essentially: it’s all well and good for some unelectable wonk in the “citadel of libertarian thinking” to “uphold ivory-tower free-market purity” by opposing price controls.  But Republicans need “art-of-the-possible solutions” to win elections, and 90 percent of the public support those price controls.  “Everyone has a right to his or her principled position,” Pinkerton writes, “but the majority has rights, too.” Two problems. First, Pinkerton suggests that l... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2871565 Wed, 07 Oct 2009 20:33:48 +0100 2871565 http://www.medworm.com/index.php?rid=2879591&cid=t_155145_123_f&fid=39036&url=http%3A%2F%2Fpediatricinc.wordpress.com%2F2009%2F08%2F19%2Finsurance-contract-negotiations%2F A few months ago, Chip from PCC responded to a blog post I wrote about negotiating with insurance companies. In my post, I was questioning if a small practice (like ours) could go up against a giant like BCBS which represents more than Photo credit: bram_app 30% of our patient panel. Chip’s comments were very insightful. The fact of the matter is most people have to pay to gain this type of insight. But Chip prefered to generously share some great pointers. So here it is. By the way, I wrote the post in a Q/A format for better context. Brandon: Let’s say I want to renegotiate our contract with BCBS, I look at the data and find out they are 30% of our patient mix. What is the first step I should take in this process? Chip: You should get a sense of how much of your *revenue* mix they a... Pediatric Inc blogs http://www.medworm.com/rss/comments.php?id=2879591 Wed, 19 Aug 2009 15:39:55 +0100 2879591 http://www.medworm.com/index.php?rid=2670900&cid=t_155145_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FF7QT3lxcVJU%2F Researchers have identified a new strain of the HIV virus. This time, the virus first came from gorillas. In the past, the strains have originated with chimpanzees. This discovery confirms that both animals are likely sources of HIV. The new strain is called RBF 168, and was first found in a woman, aged 62, who had moved to Paris from Cameroon, a nation in Africa. The woman said she did not have contact with apes or bush meat, which would mean she probably got the virus from another human. Despite this new strain, experts says it’s not likely to cause an increase in the number of AIDS cases each year. Image: sxc.hu. Share and Enjoy: Post from: Blisstree New HIV Strain Discovered (Source: A Hearty Life) A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2670900 Wed, 05 Aug 2009 06:03:30 +0100 2670900 http://www.medworm.com/index.php?rid=2653666&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fv4MERyzbrMU%2F The recent focus in Washington on mortgage modifications once again illustrates one of the most fundamental flaws in current political debate:  the notion of using government to threaten or force the “voluntary” transfer of wealth from one group of citizens to another. Just this week Rep. Barney Frank warned the banking industry if they don’t “voluntarily” do more to reduce foreclosures, Congress will step in and make them do so, by allowing bankruptcy judges to re-write mortgage contracts.  This proposal is really nothing more an ex poste transfer of wealth from investors in mortgage backed assets to borrowers. Of course, Rep. Frank and others respond that they are only trying to “bring lenders to the table” in order to keep negotiations going... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2653666 Wed, 29 Jul 2009 20:42:48 +0100 2653666 http://www.medworm.com/index.php?rid=2630053&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FUIFag96H7DQ%2F As I have written previously, President Obama and the members of Congress who voted to kill funding for the F-22 did the right thing. The Washington Post reports: The Senate voted Tuesday to kill the nation’s premier fighter-jet program, embracing by a 58 to 40 margin the argument of President Obama and his top military advisers that more F-22s are not needed for the nation’s defense and would be a costly drag on the Pentagon’s budget in an era of small wars and counterinsurgency efforts. While this vote marks a step in the right direction, the fight isn’t over. The F-22’s supporters in the House inserted additional monies in the defense authorization bill, and the differences will need to be reconciled in conference. But the vote for the Levin-McCain amendme... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2630053 Wed, 22 Jul 2009 14:34:13 +0100 2630053 http://www.medworm.com/index.php?rid=2556081&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F_9nO-FoxdPk%2F Last week, I had the opportunity to testify before the House Science Committee’s Subcommittee on Technology and Innovation on the topic of “cybersecurity.” I have been reluctant to opine on it because of its complexity, but I did issue a short piece a few months ago arguing against government-run cybersecurity. That piece was cited prominently in the White House’s “Cyberspace Policy Review” and — blamo! — I’m a cybersecurity expert. Not really — but I have been forming some opinions at a high level of generality that are worth making available. They can be found in my testimony, but I’ll summarize them briefly here. First, “cybersecurity” is a term so broad as to be meaningless. Yes, we are constructing a new “space” analogo... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2556081 Tue, 30 Jun 2009 12:48:59 +0100 2556081 http://www.medworm.com/index.php?rid=2441257&cid=t_155145_87_f&fid=34872&url=http%3A%2F%2Fwww.blisstree.com%2Fhealthbolt%2Fbetting-on-weight-loss%2F Take a gamble People bet on the horses, football, basketball, and pretty much any sport in between. So why not bet on weight loss? That’s what over a 1,000 dieters in the United Kingdom have signed up for on the StickK website. The American based start-up was created last year by two Yale professors who wanted to help people achieve their goals and objectives by enabling them to form Commitment Contracts. Dieters in the UK have been joining up and betting on their ability to lose a specified amount of weight in a specified time frame. If  you don’t succeed,  you lose money. But you don’t just lose a designated amount of money. The money that you lose is paid to a charity that you nominated when you join up. But wait, there’s a twist. You have to nominate a charity that you would ... Healthbolt blogs http://www.medworm.com/rss/comments.php?id=2441257 Sun, 24 May 2009 10:49:24 +0100 2441257 http://www.medworm.com/index.php?rid=2405417&cid=t_155145_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F12%2F8-ways-to-overcome-jealousy-and-envy%2F I know that the fastest way to despair is by comparing one’s insides with another’s outsides, and that Max Ehrmann, the author of the classic poem “Desiderata,” was absolutely correct when he said that if you compare yourself with others you become either vain or bitter, or, as Helen Keller put it: “Instead of comparing our lot with that of those who are more fortunate than we are, we should compare it with the lot of the great majority of our fellow men. It then appears that we are among the privileged.” But Helen and Max don’t keep me from going to the land of comparisons and envy. Before long, I’m salivating over someone else’s book contract, or blog traffic numbers, or “Today Show” appearance. Then I have to pull out my ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2405417 Tue, 12 May 2009 20:00:44 +0100 2405417 http://www.medworm.com/index.php?rid=2389654&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FcRLV8Ocl2WM%2F After the Senate’s rejection last week of allowing bankruptcy judges to re-write mortgage contracts, the so called “cramdown” provisions, it was starting to look as if the Senate cared about respecting private contracts. Sadly, such concern has been short-lived. Tucked away in the mortgage bill is a provision that gives servicers of mortgages, that is, the entities that collect payments and perform modifications on behalf of the actual investors in mortgages, a “safe harbor” from any litigation by investors if the servicer chooses to follow the interests of the borrower or the government, rather than fulfilling their fiduciary duty to the investors. Supporters of the safe harbor claim that too many foreclosures have taken place due to contractual restrictions ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2389654 Wed, 06 May 2009 17:07:55 +0100 2389654 http://www.medworm.com/index.php?rid=2375844&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FiHS3c0AJvS0%2F In Washington, the symbolic almost always trumps the substantive.  Thus, legislators complain, for good reason, about pork and earmarks, which ran about $35 billion at their maximum, and ignore entitlements, which entail some $100 trillion in unfunded liabilities. So it is with President Obama.  He continues the endless bailouts, which cumulatively now run around $13 trillion.  He proposed a $3.6 trillion budget and will leave us with a $1.4 trillion deficit next year–and nearly $5 trillion in additional debt on top of the massive deficits already projected over the coming decade.  But he asked his Cabinet officers to chop $100 million in administrative expenses. And he says he doesn’t need a new helicopter.  Fiscal responsibility in action. Alas, the helicopter, while... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2375844 Wed, 29 Apr 2009 14:11:46 +0100 2375844 http://www.medworm.com/index.php?rid=2375847&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FHCqoRE_cuhg%2F Here are a few highlights from Cato Today, a daily email from the Cato Institute. Dan Ikenson and Scott Lincicome argue in a new study that restoring the pro-trade consensus must be a top priority for the Obama administration. In the DC Examiner, Gene Healy discusses Obama’s first 100 days and argues that he’s massively expanded the power of government in a short period of time. In the Asia Times Online, David Isenberg discusses private security contractors in the war in Iraq. Watch Patrick J. Michaels discuss energy on CNBC. In Tuesday’s Cato Daily Podcast, Peter Van Doren discusses the interaction between Congress and regulators on the issue of food safety. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2375847 Tue, 28 Apr 2009 21:07:20 +0100 2375847 http://www.medworm.com/index.php?rid=2306729&cid=t_155145_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F24LVmhFGt18%2F G-20 Summit Agrees to International Spending Plan The Washington Post reports, “Leaders from more than 20 major nations including the United States decided Thursday to make available an additional $1 trillion for the world economy through the International Monetary Fund and other institutions as part of a broad package of measures to overcome the global financial crisis.” Cato scholars Richard W. Rahn, Daniel J. Ikenson and Ian Vásquez commented on the London-based meeting: Rahn: “President Obama of the U.S. and Prime Minister Brown of the U.K. will be pressing for more so-called stimulus spending by other nations, despite the fact that the historical evidence shows that big increases in government spending are more likely to be damaging and slow down recovery than they ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2306729 Fri, 03 Apr 2009 21:32:27 +0100 2306729 http://www.medworm.com/index.php?rid=2306976&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fsham-studies-and-commercial-irbs-that.html We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them.For example, we discussed the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel Int... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2306976 Tue, 31 Mar 2009 19:07:00 +0100 2306976 http://www.medworm.com/index.php?rid=2052666&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F12%2Fperils-of-contract-research.html The St Petersberg Times last week published an investigative series on the out-sourcing of clinical trials to India, which raised important questions about the quality of data they produce.Mary K. Pendergast, a former FDA deputy commissioner, said identifying a dangerous product is difficult enough. It's considerably trickier to find fraudulent clinical trial data, which could lead to the approval of dangerous drugs years later.'It's much more time-consuming and extraordinarily tedious,' said Pendergast, who plowed through such data when she was prosecuting doctors doing drug studies in the United States. 'It's especially hard if the trial is taking place in a different country.'Particularly when that country has a reputation for cutting corners.The article quoted a number of people famili... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2052666 Fri, 19 Dec 2008 21:47:00 +0100 2052666 http://www.medworm.com/index.php?rid=1909357&cid=t_155145_177_f&fid=38134&url=http%3A%2F%2Fbabybound.wordpress.com%2F2008%2F10%2F21%2Fthis-seems-fair%2F I see absolutely no flaw in this agreement.  This baby machine Kelly better get off her ass and start producing so I don’t have to drag her into court and wave this legally binding contract in her face. Don’t make me do it K.  Get to work!        (Source: B a b y B o u n d) B a b y B o u n d blogs http://www.medworm.com/rss/comments.php?id=1909357 Tue, 21 Oct 2008 23:55:33 +0100 1909357 http://www.medworm.com/index.php?rid=1754636&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F09%2Fblogscan-academic-contract-research.html On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discussed an article in the British Medical Journal by Jeanne Lenzer about the increasing role that contract research organizations (CROs) are taking in clinical research. Particularly enlightening were the discussions of academic CROs, a species not previously much in the limelight. It seems that medical schools, academic medical centers, and even schools of public health, stung by the loss of industry sponsored research to for-profit CROs, have spawned their own line of extra industry friendly affiliates. It seems not-for-profit academic medicine is getting less and less distinguishable from their for-profit benefactors. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1754636 Tue, 02 Sep 2008 19:37:00 +0100 1754636 http://www.medworm.com/index.php?rid=1686525&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F357448262%2F This is all about lowering R&D costs. So here’s the deal: Lilly will sell its Greenfield Laboratories site in Indiana and transfer operations to Covance, a big contract research organization, for an up-front payment of $50 million, and the two companies are also signing a 10-year service agreement worth about $1.6 billion. As a result, Covance will assume responsibility for Lilly’s toxicology testing and other R&D support activities at the 460-acre site. The deal builds on an existing agreement in which Covance already conducts pre-clinical toxicology, early-stage clinical work and Phase II and III trial support. About 260 Lilly 260 jobs will shift to Covance and another 225 will be shifted to other Lilly sites in the state. This “represents an innovative approa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1686525 Wed, 06 Aug 2008 14:23:45 +0100 1686525 http://www.medworm.com/index.php?rid=1649306&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F343830430%2F Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Alle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1649306 Wed, 23 Jul 2008 19:06:15 +0100 1649306 http://www.medworm.com/index.php?rid=1537884&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F06%2Fclinical-trials-torture-economy.html Two recent commentaries in major medical journals on the same topic failed to get the recognition they deserved. Both were about exploitation of the poor in clinical research, usually in Phase I drug trials conducted by contract research organizations (CROs), supervised by for-profit institutional review boards (IRBs), and both paid by pharmaceutical, biotechnology or device companies.The first article was by Carl Elliott and Roberto Abadie. [ Elliott C, Abadie R. Exploiting a research underclass in phase I clinical trials. N Engl J Med 2008; 358: 2316-7. Link here.] Per Elliott and Abadie, the context is:Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outso... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1537884 Mon, 23 Jun 2008 19:26:00 +0100 1537884 http://www.medworm.com/index.php?rid=1521995&cid=t_155145_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2008%2F06%2Fand-still-it-goes-on-mrsa-revisited.html We reported on this before in Two Days laterThe year's cleaning bill for the Countess of Chester hospital, including the "deep clean", was £2.325 million and it was all finished before the end of the financial year, appropriately enough on All Fools' Day. Two days later, on 3rd April 2008, the following article appeared in the local paper:Superbug outbreak at the Countess of Chester hospitalThe Countess of Chester has been hit with a superbug outbreakA WARD at the Countess of Chester Hospital remains closed following an outbreak of superbug, clostridium difficile. Ward 43 is being used for isolation purposes and has been closed to visitors since last Friday when the hospital's NHS Foundation Trust declared the outbreak. Up to 26 people were affected at the peak of the problem, but Andrew ... NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=1521995 Mon, 16 Jun 2008 16:28:00 +0100 1521995 http://www.medworm.com/index.php?rid=1432944&cid=t_155145_158_f&fid=36160&url=http%3A%2F%2Fwww.popeinstitute.com%2Fcaregivingminutes%2F%3Fp%3D80 Everyone in a specialty or professional environment has a particular jargon and terminology that sounds like a foreign language to listeners not familiar with that industry. Financial professions, health care professionals, educators, and legal professionals have industry dialects that confuse even the most enlightened consumers. Given our focus on elder care and long-term care, every week we provide insight into terms from those industries that can leave people saying “Can you repeat that?” This week’s alphabet soup is Assisted Living Assisted Living (A.L./AL) A supported living environment that provides room and board in addition to personal care support. Some support services are purchased separate from the room and board contract. Assisted living facilities usually provide pers... CaregivingMinutes™ by Pope Institute blogs http://www.medworm.com/rss/comments.php?id=1432944 Sat, 10 May 2008 00:40:01 +0100 1432944 http://www.medworm.com/index.php?rid=1389201&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F274655469%2F The huge cost and complexity of testing potential new medical products - a forbidding burden for fledgling Silicon Valley biotech firms - has given birth to an army of entrepreneurs offering to do the tests for others. Hundreds of contract research organizations have cropped up over the past two decades around the world, creating a multibillion-dollar industry that many people say provides an essential service and is bound to expand. But some say the trend has a troublesome side, according to The San Jose Mercury News. “There has been tremendous growth in the industry,” Brad Zaro, who runs Clinimetrics, a CRO in San Jose, tells the paper. Unfortunately, he adds, many of those jumping into the field “are unqualified.” The FDA has found cause for concern, too. In rece... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1389201 Mon, 21 Apr 2008 12:04:34 +0100 1389201 http://www.medworm.com/index.php?rid=1367902&cid=t_155145_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2008%2F04%2Fwhere-theres-brass-theres-muck.html Dark Satanic MillsTwo years ago, in Joseph Lister and the plastic dog turd, I wrote about the effects of contract cleaning on our Health Centre. Those interested in matters hygienic may like to know that the turd is still there, untouched, but now unrecognisable due to dust. A year later, in Filthy Patricia, I wrote about hospital contract cleaning nationwide, and a depressing picture it was too.Another  year later, it is time for another update on NHS hygiene. Dr Crippen is grateful to an NHS BLOG DOCTOR reader in Yorkshire who writes in to tell ofa "groundbreaking development" – the first in the country...as part of the national strategy for improving decontamination services.Sounds promising, tell me moreThe healthcare company, a subsidiary of B Braun Medical which employs 28,000 pe... NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=1367902 Fri, 11 Apr 2008 22:06:00 +0100 1367902 http://www.medworm.com/index.php?rid=1036875&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F11%2Fwho-do-pharmaceutical-companies-support.html On the Clinical Psychology and Psychiatry blog, this post discusses an amazing case of a psychiatrist who had his license suspended for giving genital herpes to two patients. Why is that amazing, or relevant to Health Care Renewal? The psychiatrist also is known for enrolling patients in clinical trials sponsored by no less than 11 well-known pharmaceutical companies (AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Johnson & Johnson, Novartis, McNeil, Pfizer, and Shire) and working with no less than six well-known contract research organizations (I 3 Research, INC Research, Parexel, PPD Development, Quintiles, Rho Inc).Apparently an FDA investigation of the (not so) good doctor also found he had "imprisoned" one patient, enrolled at least t... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1036875 Mon, 19 Nov 2007 19:27:00 +0100 1036875 http://www.medworm.com/index.php?rid=1020077&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F183531086%2F Welcome to the working week. Another Monday morning, which means much to do. We hope you were able to get some rest over the weekend and now feel prepared for those deadlines and meetings that await. To help you ease into the routine, we’ve gathered a few items…. Harvard Chemist Leaves For MIT-Novartis Manufacturing Center (The Harvard Crimson) India’s Fair Trade Regulator Probes Big Pharma (The Economic Times) Australian Lawyers Vow To Pursue Vioxx Lawsuits (The Age) Genzyme Eyes Isis Drug (Forbes) Glenmark To Split Branded And Generics Businesses (PharmaTimes) Contract Research Organizations Look Like Good Investor Bets (Barron’s) Bulgaria’s Pharmacies Are Ready To Strike Over Prices (SofiaEcho) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1020077 Mon, 12 Nov 2007 12:11:10 +0100 1020077 http://www.medworm.com/index.php?rid=968449&cid=t_155145_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173273492%2F Last month, the drugmaker went out of its way to insist that production in China was just a gleam in its eye - and that making active pharmaceutical ingredients, or APIs, was only being explored. The explanation was a tortured bit of backpeddling, given that one of its top execs days earlier openly discussed outsourcing production to China. Then, it became known that AZ initiated a strategy to phase out internal manufacturing altogether; the drugmaker just didn’t want it widely known, given concerns over China’s reputation for poor quality and dangerous products. Now, though, comes reality - AZ is outsourcing production of some of its bestselling meds to low-cost manufacturers in the Far East has begun, As part of a restructuring drive designed to cut $900 million in costs by 2... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=968449 Mon, 22 Oct 2007 11:09:00 +0100 968449 http://www.medworm.com/index.php?rid=906027&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F09%2Fhaunted-health-care-scope-of-ghost.html An important new article in PLoS Medicine expanded thinking about the involvement of pharmaceutical companies (and possibly other health care corporations) in the shaping of clinical research. [Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by industry? PLoS Med 4(9): e286 doi:10.1371/journal.pmed.0040286]Sismondo defined ghost management of medical research and publishing:when pharmaceutical companies and their agents control or shape multiple steps in the research, analysis, writing, and publication of articles. Such articles are 'ghostly' because signs of their actual production are largely invisible—academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility. T... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=906027 Wed, 26 Sep 2007 18:08:00 +0100 906027 http://www.medworm.com/index.php?rid=716465&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fblogscan-quickie-web-site-for-cymbalta.html On PharmaLot, this post describes a web-site that suddenly appeared with favorable information about the drug Cymbalta (duloxetine, manufactured by Eli Lilly). Based on rumors that the site was run by NovaQuest, a subsidiary of contract research organization (CRO) Quintiles Transnational, blogger Ed Silverman sent an enquiry to NovaQuest. The response was that the site had been taken down, but did not address who put it up in the first place. Are such "quickie" unattributed web-sites the latest form of stealth marketing? (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=716465 Thu, 05 Jul 2007 21:16:00 +0100 716465 http://www.medworm.com/index.php?rid=707619&cid=t_155145_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fyet-another-species-of-health-care.html The St. Petersburg (Florida) Times has an interesting story about the relationships between contract research organizations (CROs) and biotechnology and pharmaceutical companies.Like many startup businesses, Accentia BioPharmaceuticals of Tampa was long on dreams but short on cash.It held the license to an experimental sinus drug that looked like a potential blockbuster. But the company needed serious bucks to get the product to market.Accentia found an investor in PPD Inc., a company that specializes in running the studies that must be conducted before regulators can approve a drug.A year after recruiting PPD as an investor, Accentia went looking for someone to run the all-important trials proving the safety and effectiveness of its sinus drug.Guess who got the job.Now PPD is not only the... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=707619 Sun, 01 Jul 2007 21:28:00 +0100 707619