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 'clinical trials'. Sat, 03 Sep 2011 01:47:08 +0100 http://www.medworm.com/index.php?rid=5182319&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA5G531mWaWs%2F Earlier this week, the Presidential Commission for the Study of Bioethical Issues declared that US-funded researchers knew they violated ethical standards when they deliberately infected Guatemalan prison inmates and mental patients with syphillis in the 1940s. The US apologized last year and the panel was convened to investigate and a final report is due later this year. About 1,300 people were infected with venereal disease, more than half of them with syphilis, including inmates who were exposed to infected prostitutes brought into jails, and male and female patients in a mental hospital. Some subjects had bacteria poured on scrapes made on their genitals, arms or faces. And they were not informed they were participating in medical research in which they were given penicillin to determi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182319 Thu, 01 Sep 2011 16:20:37 +0100 5182319 http://www.medworm.com/index.php?rid=5182320&cid=t_91865_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_91865_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=5174741&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2011%2F08%2Fupcoming-event-cambridge-uk-12-16th.html Summer School in Applied Psychometrics From the website: Date: Monday, 12 September to Friday, 16 September Location: Peterhouse College, Cambridge Time: All Day Event "Health-related quality of life (HRQoL) is a popular and rapidly evolving area of psychometric research that builds on a long-standing methodology of self-report questionnaires. Today the assessment, analysis and interpretation of these questionnaires and of Patient-Reported Outcomes (PROs) rely upon a variety of modern psychometric methods that might be beyond the typical methodological/statistical training that researcher of related disciplines receive. This Summer School will cover the fundamentals of psychometric test theory as applied to HRQoL and PROs, with particular emphasis on latent trait/ Item Response Theory (... BrainBlog blogs http://www.medworm.com/rss/comments.php?id=5174741 Tue, 30 Aug 2011 01:34:00 +0100 5174741 http://www.medworm.com/index.php?rid=5159206&cid=t_91865_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F21%2Fthe-other-side-of-the-placebo-effect%2F This is the second in a pair of articles on the placebo effect. Nocebo is sometimes referred to as “placebo’s evil twin,” or the “negative placebo effect.”  It’s also sometimes described as “the other side of placebo.”   The nocebo effect can be defined as a negative effect that occurs after receiving treatment (therapy, medication), even when the treatment is inert (inactive, sham). It is important to note that negative effects seen when taking active substances, reported as drug side effects, can often be at least partly attributed to a a combination of effects from the substance’s constituents (specifics), and those from nocebo effects (non-specifics). Studies suggest that nocebo effects can contribute appreciably to a variety of medic... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159206 Sun, 21 Aug 2011 12:47:27 +0100 5159206 http://www.medworm.com/index.php?rid=5140181&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F08%2F18%2Fu-k-researchers-launch-clinical-trial-of-mercaptopurine-6-mp-in-women-with-hereditary-breast-and-ovarian-cancer%2F A Cancer Research UK-funded clinical trial of a new drug for patients with advanced breast or ovarian cancer due to inherited BRCA gene mutations has been launched at the Experimental Cancer Medicine Centre at the University of Oxford. A Cancer Research UK-funded trial of a new drug for patients with advanced breast or ovarian cancer [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=5140181 Thu, 18 Aug 2011 21:07:56 +0100 5140181 http://www.medworm.com/index.php?rid=5125923&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F08%2F12%2Ffda-approves-clinical-protocol-for-additional-phase-1-study-of-tkm-plk1-in-primary-liver-cancer-or-liver-metastases%2F The U.S. Food and Drug Administration approves the clinical protocol for an additional Phase 1 study of TKM-PLK1 in patients with either primary liver cancer or liver metastases associated with select cancers including ovarian. RNA Interference Nucleic acids are molecules that carry genetic information and include DNA (deoxyribonucleic acid) and RNA (ribonucleic acid). Together these [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=5125923 Fri, 12 Aug 2011 19:03:27 +0100 5125923 http://www.medworm.com/index.php?rid=5096204&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-perspective-of-the-clinical-trial-that-you-need-to-know%2F2011.08.04 There are big companies like Quintiles that run clinical trials around the world. There are local clinics that specialize in clinical trials and make a lot of money at it. There are, of course, pharmaceutical companies and device manufacturers who depend upon the results to gain marketing approval for new products. People in all those groups know a lot about trials. But the perspective that counts is the view from you and me – patients. Most of us do not enroll in clinical trials. We don’t want to get too up close and personal with anything “experimental.” And often our doctors never tell us about available trials anyway since it can be a lot of paperwork for them. Given that most people don’t enroll in trials and new science is delayed because of it and also because most people ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5096204 Thu, 04 Aug 2011 18:00:38 +0100 5096204 http://www.medworm.com/index.php?rid=5069821&cid=t_91865_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_91865_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=5062500&cid=t_91865_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_91865_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=5029205&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm__LsA3oi6M%2F In the latest move by the Republican-dominated legislature in Maine to undo laws that have made the pharmaceutical industry uncomfortable, three bills were repealed this week that required drugmakers to report three things: marketing costs, prices subject to the Medicaid Drug Rebate Program and negative findings in clinical trials. The action follows an effort last month to repeal a 2003 law that was created to prevent pharmacy benefit managers from switching patients to more expensive drugs and protect consumers from co-payments when actual drug prices are cheaper (back story). Taken together, Maine Democrats say the various repeals will roll back important patient safety protections. “It’s part of the pro-pharma agenda being pushed in Maine these days,” says Sharon Trea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029205 Fri, 15 Jul 2011 17:08:47 +0100 5029205 http://www.medworm.com/index.php?rid=5028517&cid=t_91865_111_f&fid=39123&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fnursingcomments%2Ftdtc%2F%7E3%2FTIy93UnlV6M%2F I was doing some research on clinical trials and it is much more complex than I dreamed!  First of all, any new treatment must go through numerous stages of testing before its benefits and risks can completely be known.  New treatments are discovered in the laboratory and it can take many years of research before they are given to patients.  Why?  Because it is essential to identify that the new treatment is actually better than what is already available.  These research studies are also called clinical trials.  If a treatment has definite potential in the final stages of development, then research is carried out in patients with the particular type of illness that the treatment aims to help.  Furthermore, I always believed that clinical trials were only regarding drugs, and that is... Nursing Comments blogs http://www.medworm.com/rss/comments.php?id=5028517 Thu, 14 Jul 2011 15:37:10 +0100 5028517 http://www.medworm.com/index.php?rid=5008663&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAh9019sQsPk%2F Call it a sad irony. Sanofi has discontinued a Phase IIIb trial in patients who were being treated with its Multaq heart med and suffer from permanent atrial fibrillation. Why? There was a significant increase in cardiovascular events. And so the study’s operations committee and a data monitoring committee recommended ending the trial, known as Pallas. This is only the latest setback for Sanofi and its Multaq heart med, which is supposed to bolster flagging fortunes. Last month, French regulators reevaluated the effectiveness of the drug after two patients developed severe liver damage and decided Multaq is “insufficient,” which means French authorities could withdraw reimbursement (see this). Sanofi says the decision to end the trial was not related to kidney damage (read here)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008663 Thu, 07 Jul 2011 15:49:23 +0100 5008663 http://www.medworm.com/index.php?rid=4984452&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbending-the-cost-curve-in-cancer-care-reduce-excessive-testing-for-reassurance-purposes%2F2011.06.29 This is the second in a series of posts on Bending the Cost Curve in Cancer Care. We should consider the proposal, published in the NEJM, gradually over the course of this summer, starting with “suggested changes in oncologists’ behavior,” #1: 1. Target surveillance testing or imaging to situations in which a benefit has been shown. This point concerns the costs of doctors routinely ordering CTs, MRIs and other imaging exams, besides blood tests, for patients who’ve completed a course of cancer treatment and are thought to be in remission. The NEJM authors consider that after a cancer diagnosis many patients, understandably, seek reassurance that any recurrence will be detected early, if it happens. Doctors, for their part, may not fully appreciate the lack of benefit of detecting ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4984452 Wed, 29 Jun 2011 15:00:37 +0100 4984452 http://www.medworm.com/index.php?rid=4984694&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBsXbRjQLOOo%2F Last year, the pharmaceutical industry spent about $2 billion on assorted R&D activities in India, but that figure is expected to reach a whopping $25 billion by 2025. The reasons are varied, but can be traced to expanding activities by Indian companies, additional government investment and a growing pool of qualified researchers, according to a new report by the Boston Consulting Group. The optimistic forecast reflects declining R&D productivity in regions where such work has traditionally been conducted, notably the US and Western Europe. Already, the picture is changing. In 2002, pharma spent $25.3 billion in the US, which accounted for 83 percent of the worldwide total. By 2009, that grew to $35.4 million, but represented 76 percent of the total. There were also percentage de... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984694 Wed, 29 Jun 2011 13:00:28 +0100 4984694 http://www.medworm.com/index.php?rid=4976202&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoTKlwddQleA%2F Recruiting patients for clinical trials is increasingly tricky, especially in the US, where many people remain uninterested in participation. In many cases, drugmakers are also hard-pressed to find ‘treatment naive’ patients - those who are not on other meds. The Internet, however, has opened up a new source of potentially willing participants, since so many seek health info online. But how likely are they to enroll and what might prompt them to do so? A recent survey of 179 adults, who were queried through postings in online health communities, finds that 84 percent have never participated in a trial. But of those, four of five would do so. And the reasons cited most often: 22 percent would enroll if a drug offered a cure and 21 percent if they could help find a cure. Online o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976202 Tue, 28 Jun 2011 16:22:57 +0100 4976202 http://www.medworm.com/index.php?rid=4976192&cid=t_91865_149_f&fid=35776&url=http%3A%2F%2Fpipeline.corante.com%2Farchives%2F2011%2F06%2F27%2Fmaking_the_numbers_confess.php Adam Feuerstein calls this not just "post hoc data mining", but "extreme post hoc data mining". Take a look and see what you think. (Source: In the Pipeline) In the Pipeline blogs http://www.medworm.com/rss/comments.php?id=4976192 Mon, 27 Jun 2011 16:20:14 +0100 4976192 http://www.medworm.com/index.php?rid=4968488&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnew-nasal-spray-is-the-first-of-its-kind%2F2011.06.26 Meda Pharmaceuticals has announced a new nasal spray “Dymista” that contains both a steroid and an anti-histamine active ingredient. Why is this significant? It’s because it’s the first and only one to do so. Of course, it’s not available yet until the FDA approves it, but at least it has shown effectiveness in Phase 3 clinical trials. At this time, nasal sprays as it relates to nasal allergies come in two separate flavors: 1) Steroid Nasal Spray (flonase, nasonex, nasacort, rhinocort, veramyst, omnaris, etc, etc) 2) Anti-Histamine Nasal Spray (patanase, astepro, astelin) This new combo nasal spray “Dymista” contains (more…) *This blog post was originally published at Fauquier ENT Blog* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=4968488 Sun, 26 Jun 2011 12:00:00 +0100 4968488 http://www.medworm.com/index.php?rid=4968905&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkCs8X6zlPB8%2F Earlier this week, Medco Health Solutions, the big pharmacy benefits manager, struck an unusual deal with Sanofi to help the drugmaker navigate the path from laboratory to formulary placement. Specifically, Medco will provide input on clinical trial design, help develop comparative effectiveness data and review usage of existing medications to improve patient adherence. The move reflects a growing awareness among drugmakers that designing and testing a compound for FDA approval is no longer the only key hurdle to winning sales and market share. We spoke with Robert Epstein, Medco’s clinical research and development officer, about the deal… Pharmalot: You’re saying this is the first deal of this sort. But the problems you hope to address aren’t new, right? Epstein: It’s been very ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968905 Fri, 24 Jun 2011 17:25:12 +0100 4968905 http://www.medworm.com/index.php?rid=4960273&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F06%2F22%2Fampligen%25c2%25ae-to-be-tested-in-phase-iii-study-in-tandem-with-upenn-ovarian-cancer-vaccine%2F Hemispherx Biopharma’s Ampligen® is being tested in combination with an experimental ovarian cancer vaccine developed by the Penn Ovarian Cancer Research Center. Hemispherx Biopharma, Inc. (“Hemispherx”) announced yesterday that it entered into a Material Transfer and Research Agreement with the University of Pennsylvania School of Medicine to provide Ampligen® [rintatolimod; poly(I)•poly(C12,U)], an experimental therapeutic, for [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4960273 Thu, 23 Jun 2011 03:36:50 +0100 4960273 http://www.medworm.com/index.php?rid=4945195&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-kPWew1MnL8%2F Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who are mostly farm workers and daily wagers, have developed acute joint pains, swelling in arms and throat infections. The brokers hired the women and took them to a lab in Miyapur, Hyderabad, where blood samples were taken and they were given injections and tablets, according to reports. For their trouble, the women were paid around 3,000 to 10,000 Rupees, or roughly $65 to $220, to participate in the trials that were conducted during last three months. “Though the pharma company promised to pay us huge amounts before conducting the te... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945195 Fri, 17 Jun 2011 12:28:48 +0100 4945195 http://www.medworm.com/index.php?rid=4934740&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F06%2F11%2F2011-asco-exelixis-reports-expanded-cabozantinib-xl184-phase-ii-data-for-advanced-ovarian-cancer-six-deaths-reported%2F Exelixis, Inc. reported expanded Phase 2 study data with respect to cabozantinib (XL184) use in advanced ovarian cancer patients at the recent 2011 American Society of Clinical Oncology Annual Meeting. The overall solid tumor Phase 2 safety and tolerability data reference six deaths, including two ovarian cancer patients. Exelixis, Inc. reported expanded Phase 2 study [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4934740 Sat, 11 Jun 2011 16:10:03 +0100 4934740 http://www.medworm.com/index.php?rid=4921731&cid=t_91865_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FJaHatnEnfUE%2Fpfizer-looks-to-mobile-to-help-with.html Pfizer is one of the first companies to look to mobile tools to help recruit and run a clinical trial that will not need their participants to step foot in a clinic. In the new trial for Detrol, Pfizer will compare the data collection and value to the traditional methods of collecting clinical trail data. According to Mobi Health News, This allows any one in the nation to participate in the trial. Pfizer sees this as one way to potentially cut costs off of the rising price to bring drugs to market. Janet Woodcock, MD, director, Center for Drug Evaluation and Research at FDA recently stated, “Modernization of clinical trials is a key initiative of FDA. We commend Pfizer’s progress on the REMOTE pilot and encourage all manufacturers considering other novel ideas in advancing clinical tr... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4921731 Fri, 10 Jun 2011 19:16:00 +0100 4921731 http://www.medworm.com/index.php?rid=4911822&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYT45fKpAr0s%2F In a bid to broaden use of social media, Pfizer is planning to run what will be the first clinical trial to allow patients to participate from home by using computers and smartphones instead of schlepping to a clinic or doctor’s office. By doing so, the drugmaker hopes to create a model for saving money that will rely on personal technology to more easily recruit patients and monitor their progress. The trial will test the Detrol overactive bladder drug in 10 states and results will be compared with the outcome from a conventional, 600-patient study that took place in 2007 that compared the med to a placebo over four months. The FDA has already agreed to the effort, which will be announced today at a conference on clinical trials at the National Library of Medicine. The “clinical t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911822 Tue, 07 Jun 2011 13:21:37 +0100 4911822 http://www.medworm.com/index.php?rid=4893914&cid=t_91865_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=4862926&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fq283udIKjWI%2F In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years. “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.” The guidance would require any drugmaker to submit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862926 Tue, 24 May 2011 15:43:46 +0100 4862926 http://www.medworm.com/index.php?rid=4841887&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F05%2F19%2Fasco-2011-maintenance-therapy-with-parp-inhibitors-could-play-important-role-in-treatment-of-recurrent-ovarian-cancer%2F A randomized phase II clinical trial showed that the oral PARP inhibitor drug olaparib (AZD2281), given after chemotherapy, improved progression-free survival in women with the most common type of recurrent ovarian cancer. ASCO Releases Studies From Upcoming Annual Meeting – Important Advances in Targeted Therapies, Screening, and Personalized Medicine The American Society of Clinical Oncology (ASCO) today [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4841887 Thu, 19 May 2011 18:03:58 +0100 4841887 http://www.medworm.com/index.php?rid=4841987&cid=t_91865_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=4841890&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F05%2F17%2F2011-pharmaceutical-research-manufacturers-of-america-report-lists-58-drugs-in-development-for-ovarian-cancer%2F Currently, 851 medicines are in development for diseases that exclusively or disproportionately affect women, according to a report unveiled today by the Pharmaceutical Research and Manufacturers of America (PhRMA). Currently, 851 medicines are in development for diseases that exclusively or disproportionately affect women, according to a report unveiled today by the Pharmaceutical Research and Manufacturers [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4841890 Tue, 17 May 2011 23:19:03 +0100 4841890 http://www.medworm.com/index.php?rid=4829303&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKx8Hk1e5HcM%2F Shortly after a revelation that drugmakers have not compensated survivors of most volunteers who died during studies run in India, the country’s Drugs Controller General has now issued new draft guidelines for reporting serious adverse events that occur in clinical trials. And there is also a stipulation that all info pertaining to fatalities, including compensation and care, must be reported. A key issue, however, is that drugmakers and contract research organizations are using multiple or different formats and procedures for reporting serious adverse events to the Central Drugs Standard Control Organization, or CDSCO. And so the regulators want all SAEs reported within 14 days of occurrence (as opposed to 15 days elsewhere) and a so-called causality assessment by clinical trial inv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829303 Mon, 16 May 2011 14:43:38 +0100 4829303 http://www.medworm.com/index.php?rid=4813670&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2bddsM2iuRo%2F If numbers tell a story, then the numbers pertaining to Phase II clinical trials offer a sobering tale. A new analysis finds that Phase II success rates fell from 28 percent in 2006 and 2007 to just 18 percent in 2008 and 2009, according to the Centre for Medicines Research, which examined trials undertaken by 16 drugmakers. The upshot? Phase II success rates are lower than at any other phase of development, although success rates do vary between therapeutic areas and between small molecules and biologics. Nonetheless, the implication is that the overall attrition of late-stage drug development seems to be unsustainably high. The findings appear in Nature Reviews Drug Discovery. Specifically, the analysis looked at 108 reported Phase II failures from 2008 to 2010 for new drugs and major ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813670 Wed, 11 May 2011 12:38:25 +0100 4813670 http://www.medworm.com/index.php?rid=4803524&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FL8HlrImotBE%2F Hello, everyone, and how are you today? A shiny day is unfolding on the Pharmalot corporate campus where, once again, we are scrambling to deliver the short people to the local school house. And, of course, we are quaffing our mandatory cup of stimulation. This will be a particularly busy day as we tend to podcast matters. Meanwhile, here is the news of the world. Hope your day goes well… Drugmakers Replace Reps With Digital Tools (Wall Street Journal) Pfizer’s Chantix Blamed For Murder-Suicide In Lawsuit (Pittsburgh Post-Gazette) Sanofi Wins FDA OK For Short Needle Flu Vaccine (Reuters) NSAIDs May Raise Risks After Heart Attack (Health Day) MannKind Narrow Quarterly Loss While Awaiting FDA OK (Associated Press) Aurobindo Pharma Considers Spin Offs (Wall Street Journal) US Atta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803524 Tue, 10 May 2011 12:02:42 +0100 4803524 http://www.medworm.com/index.php?rid=4803506&cid=t_91865_149_f&fid=35776&url=http%3A%2F%2Fpipeline.corante.com%2Farchives%2F2011%2F05%2F10%2Fphase_ii_failures.php We know what clinical trial success rates have been like for the last twenty years or so (hint: not so good). Are things turning around, or not? This Nature Reviews Drug Discovery piece takes a look at the 2008-2010 data. It's not necessarily reassuring: At present, however, Phase II success rates are lower than at any other phase of development. Analysis by the Centre for Medicines Research (CMR) of projects from a group of 16 companies (representing approximately 60% of global R&D spending) in the CMR International Global R&D database reveals that the Phase II success rates for new development projects have fallen from 28% (2006–2007) to 18% (2008–2009), although these success rates do vary between therapeutic areas and between small molecules and biologics. There were 108 Phase II... In the Pipeline blogs http://www.medworm.com/rss/comments.php?id=4803506 Tue, 10 May 2011 11:20:12 +0100 4803506 http://www.medworm.com/index.php?rid=4803529&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAH66PH84lEw%2F Can observational studies that rely on patient reports from an Internet site contribute meaningfully to product development and evaluation? A new study in Nature Biotechnology suggests this may be so. While such studies are no substitute for randomized clinical trials, the authors argue that patients are experimenting and swapping notes on the Internet anyway. So why not make use of such data? Moreover, they argue there are several benefits. To wit, the researchers analyzed data reported on the PatientsLikeMe web site by folks with amyotrophic lateral sclerosis (ALS) and experimented with lithium carbonate as an off-label treatment. The web site had already built a data collection tool to capture info about ALS patients who registered there and began taking the drug off-label in consultati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803529 Mon, 09 May 2011 15:15:44 +0100 4803529 http://www.medworm.com/index.php?rid=4789635&cid=t_91865_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=4789642&cid=t_91865_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=4780476&cid=t_91865_149_f&fid=35776&url=http%3A%2F%2Fpipeline.corante.com%2Farchives%2F2011%2F05%2F03%2Flucentis_and_avastin_results.php So the results are in from that Lucentis-vs-Avastin comparison (known as CATT, Comparison of AMD Treatment Trials), and I'd say that they came out the way people were expecting: monthly injections of either antibody give the same end results, as measured by vision testing. There are some slight differences between the two when retinal thickness is measured, but that hasn't shown up in the end result (visual impairment). There's another year of follow-up ongoing, and perhaps that will show something (or perhaps not). For now, the outcome appears to be the same. Another interesting feature of this study is that it compared regular monthly treatment with either drug to an "as-needed" dosing schedule. In this case Lucentis performed equally well by either schedule, with monthly Avastin equiva... In the Pipeline blogs http://www.medworm.com/rss/comments.php?id=4780476 Tue, 03 May 2011 16:27:20 +0100 4780476 http://www.medworm.com/index.php?rid=4775560&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F05%2F02%2Fexperimental-drug-nvp-bez235-slows-ovarian-cancer-growth-in-mice-solid-tumor-clinical-trials-ongoing%2F A study conducted recently at UCLA’s Jonsson Comprehensive Cancer Center found that experimental drug NVP-BEZ235, which blocks two points of a crucial cancer cell signaling pathway, inhibits the growth of ovarian cancer cells and significantly increases survival in an ovarian cancer mouse model. A study conducted recently at  UCLA’s Jonsson Comprehensive Cancer Center (JCCC) found that an experimental drug, which [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4775560 Mon, 02 May 2011 22:46:06 +0100 4775560 http://www.medworm.com/index.php?rid=4759039&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlVjvoT8rNwo%2F The sad case of Dan Markingson appears to have no end. The latest twist is playing out as an issue of academic freedom at the University of Minnesota where, seven years ago, researchers ran a clinical trial in which the 26-year-old participated. But the circumstances surrounding his participation and subsequent death led to widely publicized allegations the university put its own interests first. One university researcher also consulted for AstraZeneca, which sells the drug and sponsored the study. And researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson’s mother, who objected to her son’s participation because he was already mentally ill and possibly incompetent, but was enrolled anyway. Her lawsuit went nowher... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759039 Wed, 27 Apr 2011 15:16:18 +0100 4759039 http://www.medworm.com/index.php?rid=4759043&cid=t_91865_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=4758780&cid=t_91865_107_f&fid=36672&url=http%3A%2F%2Fwww.sciencebase.com%2Fscience-blog%2Flatest-science-news.html Crowdsourcing a clinical trial to treat ALS – Amyotrophic lateral sclerosis (ALS) is a pretty grim disease. Victims experience progressive muscle weakness, leading to death; patients survive a median of only two to five years following the onset of symptoms. Currently, there are no effective therapies. So it's not surprising that when a preliminary study shows a hint of efficacy, patients will do what they can to get access to the drug and share their experiences with fellow patients. A company called PatientsLikeMe has now used this tendency to share information to crowdsource a sort of clinical trial, obtaining data on the effectiveness of off-label use of a drug. China seizes 26 tonnes of melamine-tainted milk powder – It's the food story we hoped we'd heard t... Sciencebase Science Blog blogs http://www.medworm.com/rss/comments.php?id=4758780 Wed, 27 Apr 2011 09:00:16 +0100 4758780 http://www.medworm.com/index.php?rid=4742387&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhow-much-does-it-cost-to-bring-one-drug-to-market%2F2011.04.22 Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year. A huge challenge facing consumers, insurers, and governments worldwide are the acquisition costs of drugs. On this point, the pharmaceutical industry makes a consistent argument: This is a risky business, and it costs a lot to bring a new drug to market. According to PhRMA, the U.S. ph... Better Health blogs http://www.medworm.com/rss/comments.php?id=4742387 Fri, 22 Apr 2011 14:00:37 +0100 4742387 http://www.medworm.com/index.php?rid=4709421&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLkVjXZZZV0c%2F Under the gun to improve product safety, the FDA wants to amend existing regulations so that it would be easier to disqualify clinical investigators from conducting any trials that would be used to support applications for research or marketing a product. “Under this proposal, when the (FDA commish) determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA,” according to the notice today in the Federal Register. Currently, the FDA may consider disqualification when an investigator has repeatedly or deliberately failed to comply with requirements fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709421 Wed, 13 Apr 2011 15:36:30 +0100 4709421 http://www.medworm.com/index.php?rid=4704957&cid=t_91865_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=4677098&cid=t_91865_149_f&fid=35776&url=http%3A%2F%2Fpipeline.corante.com%2Farchives%2F2011%2F04%2F04%2Fupdate_on_avastin_and_lucentis.php The Lucentis/Avastin story is going to get more complicated as the year goes on. Next month the results of a head-to-head study of the two drugs (one far less costly than the other) in cases of macular degeneration will be revealed, and it's widely thought that they'll come up as basically equivalent in efficacy. But as this Wall Street Journal article makes clear, they may not be equal in safely. The same meeting that will see the trial results presented will also feature an analysis of Medicare claims for both drugs, which looks like it'll show that Lucentis has a better safety profile. This is exactly what Roche/Genentech would like to hear, naturally. We'll have to wait until May to see which message wins out. . . (Source: In the Pipeline) In the Pipeline blogs http://www.medworm.com/rss/comments.php?id=4677098 Mon, 04 Apr 2011 13:03:31 +0100 4677098 http://www.medworm.com/index.php?rid=4670312&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2011%2F04%2Fabout-all-those-studies.html Please don't tell me I am the only one who finds the nonstop barrage of studies telling me to use olive oil its a good fat, or coffee will affect chronic pain, or this new wonder drug will save us all, or what they told us last week, last month, last year is now wrong is just plain confusing? I can't be alone here.So then I found this lovely article telling me "Almost Everything You Hear About Medicine Is Wrong". I learned that there are people out there who make their career out of proving these studies wrong. Its not that anyone has the intention, usually, of misleading us but most of the time, they meant well but something else was missing. Maybe more time was needed, maybe there was a statistical anomaly (big words for early in the day) or something else. I mean Thalidomide was meant t... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4670312 Sun, 03 Apr 2011 11:44:00 +0100 4670312 http://www.medworm.com/index.php?rid=4664476&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxYlfDINAsQc%2F And so, another working week is about to end. This is, of course, the celebrated signal to daydream about weekend plans. Our agenda includes watching one of the short people in a lacrosse match, dining with some of our favorite relatives and promenade with the official Pharmalot mascots. And you? Maybe you can watch that movie you never saw or catch up on some reading. How about spending time with a special someone? Whatever you do, be safe and enjoy. Catch you soon… Sanofi Faces Shareholder Suit Over Acomplia Data (Reuters) Japan Nuclear Crisis Adds Urgency To Radiation Drugs (New York Times) The Rise In Stolen Pharmaceuticals (Fortune) Paxil May Make Adults More Suicidal (Reuters) Fire Damages Roche Warehouse In Hungary (Budapest Business Journal) Fertility Drug May Be Linked To Fa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664476 Fri, 01 Apr 2011 11:49:14 +0100 4664476 http://www.medworm.com/index.php?rid=4664434&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2011%2F04%2Foverly-hyped-news.html We all hear the news - the endless hype on Charlie Sheen, Lindsay Lohan, Libya, Japan, and everything else. The media puts out an endless stream of updates from live camera shots, press releases and conferences, and announcements from PR agencies. We get so much "non-news" and there is such an effort to fill the hundreds or thousands of television channels and radio stations with more news, that sometimes news sneaks out before its ready. Companies offer endless streams of announcements and press releases. And sometimes they talk about what a product is supposed to do before they know it will work. This raises expectations on the part of the reader who doesn't always hear that it is expected to work but that it will work. The pharmaceutical industry is not immune to this. Amgen and Takeda ... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4664434 Fri, 01 Apr 2011 10:22:00 +0100 4664434 http://www.medworm.com/index.php?rid=4658583&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F03%2F30%2F2011-aacr-annual-meeting-select-ovarian-cancer-presentations-abstracts-available-online%2F The 102nd American Association For Cancer Research (AACR) Annual Meeting will be held from Saturday, April 2 through Wednesday, April 6, 2011, at the Orange County Convention Center located in Orlando, Florida.  Select ovarian cancer presentations and abstracts are available online. The 102nd American Association For Cancer Research (AACR) Annual Meeting will be held from [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4658583 Wed, 30 Mar 2011 20:23:54 +0100 4658583 http://www.medworm.com/index.php?rid=4653604&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fg_5vLHyT1fE%2F The vast majority of heart failure cases occur in adults aged 65 and older, but a new study in the Archives of Internal Medicine finds that many clinical trials studying the disease exclude older patients. The implication? Most of the meds that are being developed to treat heart disease have not been tested on the very patients who will be taking the drugs. To wit, 64 of 251 trials investigating meds for heart failure, or 25.5 percent, excluded patients by an arbitrary upper age limit. This happened 32.3 percent of the time in the European Union compared with 16.2 percent of trials in the US. Exclusion also was found more often in public institutions compared with private entities - 35.6 percent versus 13.9 percent. Overall, 109 trials, or 43.4 percent, had one or more poorly justified exc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653604 Tue, 29 Mar 2011 15:19:44 +0100 4653604 http://www.medworm.com/index.php?rid=4636621&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F03%2F25%2Ftherapeutic-response-to-the-angiogenesis-inhibitor-sunitinib-in-ovarian-clear-cell-cancer%2F A group of international researchers reported sustained responses in two ovarian clear cell cancer (OCCC) patients with chemotherapy-resistant disease, who were treated with the anti-angiogenesis inhibitor sunitinib (Sutent®). The researchers emphasize the growing realization that OCCC is molecularly and clinically distinct as compared to other forms of ovarian cancer, and note significant common scientific characteristics [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4636621 Fri, 25 Mar 2011 22:57:20 +0100 4636621 http://www.medworm.com/index.php?rid=4631481&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhen-less-is-more-smaller-doses-of-chemo-may-be-equally-effective-in-aml%2F2011.03.24 A recent issue of the New England Journal of Medicine includes an article with the bland title Cytarabine Dose for Acute Myeloid Leukemia. AML is an often-curable form of leukemia characterized by rapidly-growing myeloid white blood cells. Cytarabine — what we’d call “Ara-C” on rounds  — has been a mainstay of AML treatment for decades. The new report* covers a fairly large, multicenter, randomized trial of adult patients with AML. The researchers, based in the Netherlands, Switzerland, Belgium and Germany, evaluated 860 patients who received either intermediate or high doses of Ara-C in their initial, induction chemotherapy. According to the journal, “this investigator-sponsored study did not involve any pharmaceutical companies.” The main finding was that at a median follo... Better Health blogs http://www.medworm.com/rss/comments.php?id=4631481 Thu, 24 Mar 2011 18:00:58 +0100 4631481 http://www.medworm.com/index.php?rid=4622503&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_nQ1_zS9Qoc%2F As we know, doctors who sign up as clinical trial investigators have certain responsbilities. These include, but are not limited to, protecting the rights, safety and welfare of participants; ensuring the control of drugs used in the trial, personally conducting the trial and supervising other activities. However, while certain tasks can be delegated, general responsibilities may not. But one doctor failed to follow through. To wit, he relied on a research nurse to carry out all sorts of things back in 2007. Such as? The nurse signed his name on protocol documents, including a financial disclosure form and two serious adverse event reports. Meanwhile, two of four subjects did not meet eligibility criteria. Yet, the doctor was apparently unaware until another research nurse told him. As the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622503 Tue, 22 Mar 2011 21:12:28 +0100 4622503 http://www.medworm.com/index.php?rid=4600793&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE8s7is_0mk0%2F The federal government was asked by a watchdog group to investigate several allegedly “unethical long-term, placebo-controlled studies” for indacterol, a Novartis drug for treating moderate to severe chronic obstructuve pulmonary disease. Why? “The studies were marred by a failure to minimize risk to subjects and inadequate information provided to subjects,” according to Public Citizen. In a letter sent to the Office for Human Research Protections at the US Department of Health and Human Services, the group alleges there six “unethical” studies in which placebo-control subjects received prolonged substandard care. Put another way, Public Citizen charges the patients were prevented from using widely acknowledged standard care and that informed consent was... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600793 Wed, 16 Mar 2011 17:47:48 +0100 4600793 http://www.medworm.com/index.php?rid=4600795&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfXx2YtVF-qo%2F More clinical trials may be run overseas, but work has not dried up in the US. In fact, a robust Phase I industry continues, but there are concerns since many volunteers supplement their incomes by enrolling in trials as often as possible. Consequently, sponsors and investigators worry data will be skewed by people who enroll too soon after participating in other trials. Patient advocates, meanwhile, worry about the risks participants may face from exposure to some meds and follow-up care. And so once again, the notion of a national Phase I clinical trial registry is being raised. The latest call for action comes from a pair of physicians who published a commentary piece this week in the Journal of the American Medical Association. In their view, a registry is long overdue in the US in ord... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600795 Wed, 16 Mar 2011 15:01:29 +0100 4600795 http://www.medworm.com/index.php?rid=4600752&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2011%2F03%2Fis-clinical-trial-that-good.html People with late stage or recurrent cancer are often very hopeful to get into a clinical trial. But clinical trials are randomized. This means if you get into a clinical trial, it doesn't mean you are getting the new treatment. They are done as a blind test - no one knows if you are getting the new treatment or the current standard treatment. And there is no guarantee if the new treatment is any better than the current protocol.I think I have blogged about this before but this article explains the whole process better than I probably could. Clinical trials are very important and should not be avoided. In fact, we would probably be better off if we participated in more of them. I do not mean to cast doubt on their importance but I think it is important that people understand a clinical tria... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4600752 Wed, 16 Mar 2011 10:26:00 +0100 4600752 http://www.medworm.com/index.php?rid=4592394&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fa-new-treatment-for-lupus%2F2011.03.15 Lupus, an autoimmune disease, [recently] turned up on the front page of the Wall Street Journal (WSJ). It cropped up, also, on the first page of the New York Times business section, and elsewhere. Scientific American published a nice online review just now. The reason is that the FDA has approved a new monoclonal antibody for treatment of this condition. The drug belimumab (Benlysta), targets a molecule called BlyS (B-lymphocyte Stimulator). The newspapers uniformly emphasize that this drug marks some sort of triumph for Human Genome Sciences, a biotech company that first reported on BlyS in the journal Science way back in 1999. BlyS triggers B cells to produce antibodies that in patients with lupus tend to bind and destroy their own cells’ needed machinery, causing various joint, lung... Better Health blogs http://www.medworm.com/rss/comments.php?id=4592394 Tue, 15 Mar 2011 18:00:36 +0100 4592394 http://www.medworm.com/index.php?rid=4565902&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fniche-science-and-targeted-medicines-vs-magic-bullets%2F2011.03.09 Maybe you read the other day in The New York Times that the pharmaceutical industry has a problem. Big blockbuster drugs like Lipitor are going off patent and the industry leaders don’t have new blockbusters showing promise to replace them. So the big companies search for little companies with new discoveries and they consider buying them. Industry observers think the days of $5 billion-a-year drugs to lower cholesterol or control diabetes may be past for awhile, and the companies will have smaller hits with new compounds for autoimmune conditions and cancer. When I saw my oncologist for a checkup yesterday — the news was good — we chatted about the article and the trend toward “niche science.” We welcomed it. We didn’t think — from our perspective — the wor... Better Health blogs http://www.medworm.com/rss/comments.php?id=4565902 Wed, 09 Mar 2011 22:30:58 +0100 4565902 http://www.medworm.com/index.php?rid=4566339&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP09cTmu9FyE%2F In recent years, the meta-analysis has taken on new prominence. These are, of course, not new studies, but detailed reviews combining results of several studies in order to address a hypothesis. Perhaps one of the most high-profile examples was published in 2007 in The New England Journal of Medicine and determined the Avandia diabetes pill led to a greater chance of cardiovascular risk. However, the meta-analysis has also been criticized as an imperfect beast, since sources of bias are not controlled by method, which is considered a weakness. A new study, though, has found another reason to take issue - most meta-analysis authors are not examining whether the authors of the underlying randomized, controlled clinical trials have disclosed conflicts of interest. Specifically, of 29 meta-ana... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4566339 Wed, 09 Mar 2011 13:59:53 +0100 4566339 http://www.medworm.com/index.php?rid=4545255&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj7-yb8Q-oVg%2F Rise and shine, everyone, another shiny day is on the way. What lies in store? Meetings and deadlines, no doubt, and we relate. To cope, we are brewing our mandatory cup of stimulation and invite you to join us. Meanwhile, we will pause to hustle one of the short people off to the local schoolhouse. So here are a few tidbits. Also, please note that we posted some items last night, but placed them above our morning greeting in the event some people did not see them. Have a great day and stay in touch… Traditional Drug Discovery Model Is Ripe For Reform (Nature) McKesson Fights $212M Pricing Fine Levied By Arizona (Courthouse News) Lilly To Outsource Bioanalytical Work (Pharma Times) Eisai To Cut 900 Jobs Over Five Years (Bloomberg News) Panel Told No Guarantees Against Unethical Resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4545255 Thu, 03 Mar 2011 12:00:30 +0100 4545255 http://www.medworm.com/index.php?rid=4532547&cid=t_91865_149_f&fid=35776&url=http%3A%2F%2Fpipeline.corante.com%2Farchives%2F2011%2F02%2F28%2Fdown_in_phase_iii_again.php Past performance (Phase II results) are no guarantee of future success (Phase III). That warning has been proven over and over in this business, and an awful lot of time, effort, and money have gone down the waste chute in the process. To give you an idea, though, of how hard it is to break out of that cycle, consider Renovo. As the InVivoBlog details, Renovo was founded to try out ideas to reduce scar tissue formation. And their whole strategy was to go into humans as quickly as possible, to firm up the clinical relevance of their candidate therapies. That's a bit easier to do with something like scarring, if you can find patients willing to have small cuts made in their skin. That's just how one of the Phase II trials was run for the company's Juvista (recombinant TGF beta 3) - two cuts... In the Pipeline blogs http://www.medworm.com/rss/comments.php?id=4532547 Mon, 28 Feb 2011 14:07:53 +0100 4532547 http://www.medworm.com/index.php?rid=4507583&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FV52maQaohbs%2F Hello, everyone, and nice to see you again. We hope you had a relaxing weekend and feel refreshed. Now, of course, the time has come to resume the routine of meetings and deadlines. To cope, we are reaching for the mandatory cup of stimulation and invite you to join us. Meanwhile, here are a few tidbits to get you started. Hope your day goes well and drop us a line if you hear something of interest… Forest Labs To Pay $1.2B For Clinical Data And An Antidepressant (Reuters) Gilead To Buy Calistoga Pharma For $375M (Silicon Valley Business Journal) Medtronic To Eliminate Up to 2,000 Jobs (Bloomberg News) Elan Reports 10 More PML Cases With Tysabri (Irish Examiner) Merck Vioxx Settlement Causes Money Fight Among Lawyers (Bloomberg News) Sanofi Looks For Generics And OTC Brands In India ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507583 Tue, 22 Feb 2011 12:59:38 +0100 4507583 http://www.medworm.com/index.php?rid=4464594&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2011%2F02%2Fwill-there-be-biotechs-emerging-from.html Investors ready to craft new biotechs out of Pfizer's discardsFebruary 9, 2011 — 8:47am ET By John CarrollFierceBiotechRead the article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4464594 Fri, 11 Feb 2011 12:07:00 +0100 4464594 http://www.medworm.com/index.php?rid=4464595&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2011%2F02%2Frough-times-for-uk-neuroscience.html From The Guardian:Cuts disastrous for brain science research, academics warnAt least 30 neuroscience units to go under cuts proposed by Biotechnology and Biological Sciences Research CouncilIan Sampleguardian.co.uk Thursday 10 February 2011 21.14 GMT[snip]"The closure of drug company research facilities and "draconian" funding cuts will have a disastrous impact on brain science in Britain, senior academics have warned."At least 30 neuroscience research groups are expected to fold under cuts proposed by the Biotechnology and Biological Sciences Research Council (BBSRC), adding to jobs already lost after big pharmaceutical companies shut research programmes or moved them abroad."[snip]Read the full article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4464595 Fri, 11 Feb 2011 11:12:00 +0100 4464595 http://www.medworm.com/index.php?rid=4460184&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqDbHsZjf4IQ%2F Some scandals will just not go away. Consider the Trovan affair. In recent months, a cable disclosed by WikiLeaks indicated Pfizer hired investigators to use ‘dirty tricks’ to force the Nigerian government into a settlement (see this). A group of Nigerians and their families filed a lawsuit against the drugmaker for $384 million over their unhappiness with settlement requirements (read here). And now, a former Pfizer employee has written a federal court judge with his own account of alleged misdeeds surrounding the episode, which began back in 1996. Ironically, these latest developments occurred after Pfizer agreed to a $75 million settlement to resolve civil and criminal charges brought by the Kano State government in Nigeria, and hoped the matter would end. For those unfamili... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4460184 Thu, 10 Feb 2011 13:24:27 +0100 4460184 http://www.medworm.com/index.php?rid=4455484&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmsXo3RF7Rpo%2F For much of the past year, the FDA accelerated approval program has come under withering scrutiny. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found a lack of clinical benefit and an unexpected number of deaths. But the study didn’t get under way until four years after approval was granted in 2000 (back story). More recently, the FDA decided the breast-cancer indication for Roche’s Avastin should be withdrawn after studies found patients on the med and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients suffered more serious side effects. The decision amounted to an about-face, having endorsed the indication in 2008 under accelerated approval (look here). And so the FDA’s Oncologic Drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455484 Wed, 09 Feb 2011 14:06:27 +0100 4455484 http://www.medworm.com/index.php?rid=4455485&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJX184xjbHIA%2F In December 2009, the Anesthesia & Analgesia journal published a study by Joachim Boldt, a prominent German anesthesiologist, but a few readers raised questions about the data and, after some digging around by the editor, the article was retracted last October. Now, though, a state medical association in Germany, where the research was supposedly conducted, investigated a long list of studies attributed to Boldt and released some startling findings. To wit, Boldt failed to take a required step: there was no evidence that he obtained Institutional Review Board approval to conduct research for 92 articles - count ‘em, 92. As you might imagine, this suggests dozens more retractions may be in the offing and further reviews have been under way, according to this letter from the edito... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455485 Wed, 09 Feb 2011 13:17:42 +0100 4455485 http://www.medworm.com/index.php?rid=4450291&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fear-infections-to-treat-or-not-to-treat%2F2011.02.08 Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27 percent of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis. In the 1980s, that consensus began to change. We realized that as many as 80 percent of uncomplicated ear infections resolve without treatment in three days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4450291 Tue, 08 Feb 2011 22:00:44 +0100 4450291 http://www.medworm.com/index.php?rid=4450518&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSxHKLul2w-s%2F Nearly seven years ago, 26-year-old Dan Markingson killed himself while participating in a clinical trial at the University of Minnesota, where researchers were studying the Seroquel antipsychotic. And the circumstances surrounding his participation and subsequent death led to widely publicized allegations that the university put its own interests ahead of the patient. How so? One reason - an academic researcher also consulted for AstraZeneca, which markets the pill and sponsored the study. And the researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson’s mother, who objected to her son’s participation because he was already mentally ill and possibly incompetent, but was enrolled anyway (background here). H... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450518 Tue, 08 Feb 2011 21:21:42 +0100 4450518 http://www.medworm.com/index.php?rid=4433289&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F02%2F03%2Ffda-awards-1-6m-orphan-drug-grant-for-clinical-phase-ii-development-of-egen-001-for-treatment-of-ovarian-cancer%2F EGEN, Inc. announced that the Food and Drug Administration (FDA) awarded the company a four-year grant of $1.6 million to assist in the phase II clinical development of EGEN-001, the company’s lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer. EGEN, Inc. announced that the Food and Drug Administration (FDA) [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4433289 Thu, 03 Feb 2011 21:52:52 +0100 4433289 http://www.medworm.com/index.php?rid=4424395&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F02%2F01%2Fnovel-cancer-targeting-cornell-dot-nanoparticle-approved-for-first-in-human-clinical-trial%2F “Cornell Dots” — brightly glowing nanoparticles — may soon be used to light up cancer cells to aid in diagnosing and treating cancer. The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of the new technology. It is the first time the FDA has approved using an inorganic material [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4424395 Tue, 01 Feb 2011 23:26:35 +0100 4424395 http://www.medworm.com/index.php?rid=4399770&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F01%2F25%2Foutside-the-box-the-rogosin-institute-is-fighting-cancer-with-cancer-cells-in-clinical-trials%2F Researchers at the Rogosin Institute are using cancer “macrobeads” to fight cancer.  Cancer cells in the beads secrete proteins which researchers believe could signal a patient’s cancer to stop growing, shrink or even die. The treatment is currently being tested in human clinical trials. Two groundbreaking preclinical studies demonstrate for the first time that encapsulated [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4399770 Wed, 26 Jan 2011 05:36:17 +0100 4399770 http://www.medworm.com/index.php?rid=4394748&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpXbefPvyX2U%2F As drugmakers look to do more business in more foreign markets, corruption is always an issue, yes? That’s particularly true now that 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. Over the past year, several 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. One aspect of the probe reportedly involves exploring whether drugmakers and clinical trial organizations pay off third-party investigators to finesse research data. A report by the HHS Office of Inspector General noted that eight percent of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394748 Mon, 24 Jan 2011 16:01:22 +0100 4394748 http://www.medworm.com/index.php?rid=4372132&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2011%2F01%2Fupcoming-alzheimers-fda-advisory.html From the FDA (.pdfs of briefing material is available at the link below):January 20-21, 2011: Peripheral and Central Nervous System Drugs Advisory Committee Meeting AnnouncementRead the full announcementAgenda"On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease."On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with... BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4372132 Wed, 19 Jan 2011 01:26:00 +0100 4372132 http://www.medworm.com/index.php?rid=4372133&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2011%2F01%2Falzheimers-products.html FromThe New York Times:Tests Show Promise for Early Diagnosis of Alzheimer’sBy GINA KOLATAThe New York TimesPublished: January 18, 2011"Researchers report major advances on two vexing questions about Alzheimer’s: How do you know if someone who is demented has it? And how can you screen the general population for risk?"Read the full article.The report includes discussion about this week's forthcoming FDA Advisory Committee discussion about Avid Radiopharmaceuticals product. (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4372133 Wed, 19 Jan 2011 01:14:00 +0100 4372133 http://www.medworm.com/index.php?rid=4338266&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYyI_ups9eUA%2F Concerned with a slowdown in clinical research in the UK, the Academy of Medical Sciences has issued a report calling for a new independent health agency in hopes of simplifying regulation and speeding the pace at which clinical trials are approved and conducted. In other words, trim the bureaucracy. The Medicines and Healthcare products Regulatory Agency came in for particular criticism, by the way. In discussing its findings, the AMS pointed out that the proportion of UK patients recruited into trials fell to 2 percent of the worldwide total in 2006 from 6 percent just six years earlier. Moreover, the proportion of drugs and devices in European Union clinical trials developed in the UK was 24 percent in 2007, down from 46 percent in 2002. “There is widespread agreement that the reg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4338266 Wed, 12 Jan 2011 13:56:12 +0100 4338266 http://www.medworm.com/index.php?rid=4331240&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffs_tQgfFVm0%2F Nothing like a trade off between generations. A new study suggests that extending data exclusivity for small molecule brand-name drugs will lead to higher drug costs in the short term, but down the road, more than 200 additional drugs would be approved as a result of the increased revenue generated, offering increased industry incentives. And this would also boost life expetancy for future generations. In other words, today’s patients pay more, but tomorrow’s patients can get a better deal. Data exclusivity, you may recall, refers to the exclusive access to clinical trial data and, right now, brand-name drugmakers are granted five years for data submitted during the FDA approval process. There’s also an extra three years for supplemental applications and six months more f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331240 Mon, 10 Jan 2011 14:55:34 +0100 4331240 http://www.medworm.com/index.php?rid=4313980&cid=t_91865_87_f&fid=36069&url=http%3A%2F%2Ffrankiespeakingfrankly.blogspot.com%2F2011%2F01%2Fclinical-trials-in-medworm-thanks.html It was on the 3rd December 2007 that the wonderful Leonard Sender MD, adolescent and young adult cancer oncologist (now Medical Director of the Cancer Institute at Children's Hospital of Orange County as well as chair of on the board of directors on the also fabulous I'm Too Young For This! cancer foundation for young adults) contacted me with an idea for MedWorm - to use it to disseminate information regarding clinical trials. I only spoke to him I think once (or maybe twice), never met him in person, but he was so supportive and enthusiastic about MedWorm he made a big impact on me in the short few minutes that we spoke.Well, 3 years later, I finally got round to adding clinical trials as new data streams being fed into MedWorm. They only got added properly at the weekend so it will take... Frankie Speaking Frankly blogs http://www.medworm.com/rss/comments.php?id=4313980 Wed, 05 Jan 2011 19:52:00 +0100 4313980 http://www.medworm.com/index.php?rid=4277794&cid=t_91865_87_f&fid=34470&url=http%3A%2F%2Fwww.thehealthcareblog.com%2Fthe_health_care_blog%2F2010%2F12%2Fhuman-farming-the-limits-of-medical-research.html By FRANK PASQUALE A Museum of Modern Art exhibit by Michael Burton once proposed that human beings themselves would be the soil for a “future farm:” Future Farm predicts that the emerging pharmaceutical research in harvesting adult stem cells from... (Source: The Health Care Blog) The Health Care Blog blogs http://www.medworm.com/rss/comments.php?id=4277794 Tue, 21 Dec 2010 00:00:00 +0100 4277794 http://www.medworm.com/index.php?rid=4241832&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F12%2Fschizophrenia-drug-deadlock.html "The Drug Deadlock"Nature11 November 2010Download the article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4241832 Wed, 08 Dec 2010 04:59:00 +0100 4241832 http://www.medworm.com/index.php?rid=4233293&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F12%2Ffda-rejects-ezogabine.html FDA rejects a new epilepsy drug from Valeant, GSKFierceBiotech02 December 2010Read FierceBiotech article here===Earlier blog post on topic, from 12th August: here=== (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4233293 Mon, 06 Dec 2010 15:00:00 +0100 4233293 http://www.medworm.com/index.php?rid=4214486&cid=t_91865_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=4200564&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fimproving-health-for-older-adults%2F2010.11.24 New clinical trials and published research are giving us information on how to improve health in elderly patients. Here are some brief points from the Cleveland Journal of Medicine that were surprising to me: – Each year 30 percent of people age 65 or older fall and sustain serious injuries so preventing falls and fractures is important. Vitamin D prevents both falls and fractures, but mega doses of Vitamin D (50,000 mg) might cause more falls. A better dose is 1,000mg a day in people who consume a low-calcium diet.  – Exercise boosts the effect of influenza vaccine. – The benefits of dialysis in older patients is uncertain, as it does not improve  function in people over age 80. We don’t even know if it improves survival. Older patients who receive dialysis... Better Health blogs http://www.medworm.com/rss/comments.php?id=4200564 Wed, 24 Nov 2010 21:00:00 +0100 4200564 http://www.medworm.com/index.php?rid=4179403&cid=t_91865_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2FbIK4cuhZ8z0%2F Discussions (Members-only links below. To Learn More and Join Council, click Here) Now let’s take a look at the great things going on with the SharpBrains Council. Council Membership 60 Council Members are already active in the Council members-only platform, bringing an excellent cross-sector participation and featuring innovative research, products, services and practices. The Member List available in the Library section includes interests and 2011 priorities, to facilitate connections. We are featuring: 7 most active Council Members: Philip Toman, Jamie Wilson, Luc Beaudoin, Joshua Steinerman, Pascale Michelon, Adam Gazzaley and Sherrie All. 7 Council Members doing great work outside the US: Peter Reiner, Veronika Litinski and David Tal in Canada; Jenny Brockis and Steve Zanon in A... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=4179403 Thu, 18 Nov 2010 17:05:02 +0100 4179403 http://www.medworm.com/index.php?rid=4179525&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXGVfJpCTsxU%2F Hello, everyone. Another shiny day is unfolding here at the Pharmalot corporate campus where, as usual, we are hustling short people off to the local school house and brewing the mandatory cup of stimulation. A truly busy day, however, lies in store. You know that feeling, yes? So please join us as we prepare for another round of meetings and deadlines. And of course, here are some tidbits to get us going. Have a good one and see you soon… Pfizer And Cipla May Ink Global Supply Deal (The Times of India) Genzyme Sells Diagnostic Unit To Sekisui Chemical (Reuters) India Tightens Clinical Trial Guidelines (Outsourcing Pharma) Israeli Biotechs Flock To Ohio For Funds And Experts (Bloomberg News) FDA Panel Backs Merck’s Gardasil To Thwart Anal Cancer (Associated Press) Montana Gover... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179525 Thu, 18 Nov 2010 12:55:37 +0100 4179525 http://www.medworm.com/index.php?rid=4164583&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F11%2Ftop-10-phase-iii-failures-of-2010.html From FierceBiotech, an interesting report:Full article: Top 10 Phase III Failures of 2010 (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=4164583 Sat, 13 Nov 2010 21:23:00 +0100 4164583 http://www.medworm.com/index.php?rid=4163029&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F11%2F12%2Fovarian-cancer-drug-amg-386-shows-promise-with-move-to-phase-3-trials-in-australia-canada-europe%2F A new drug (AMG 386) designed to arrest ovarian cancer cell growth by inhibiting blood vessel formation is being readied for a phase 3 trial in Australia, Canada and Europe. AMG 386, a new drug designed to arrest ovarian cancer cell growth by inhibiting blood vessel formation, is being readied for a phase 3 trial [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4163029 Fri, 12 Nov 2010 21:27:07 +0100 4163029 http://www.medworm.com/index.php?rid=4152269&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3yG435Uz4QM%2F A controversial issue that has plagued the FDA is the notion that a drug is approved, but then a drugmaker is required to conduct a post-marketing study, yet the study is never completed or simply drags on too long. At the same time, a backlog of reviews can pile up. And so the Food and Drug Administration Amendments Act of 2007 requires the agency to provide an annual status report. The latest finding? Forty percent of the trials were closed, which means these were either fulfilled or the drugmaker was released from its requirement, according to the agency’s second annual review, which involved 1,551 post-marketing studies. Of the remaining 60 percent, most were deemed to be on schedule or a final report was submitted for FDA review. The backlog of studies dates to when the FDAAA wa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152269 Wed, 10 Nov 2010 14:08:35 +0100 4152269 http://www.medworm.com/index.php?rid=4139478&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8b4V5ZDEQ4A%2F John Arditi has created quite a stir. The former senior director for worldwide regulatory affairs at MannKind recently filed a wrongful termination lawsuit against the drugmaker for allegedly retaliating against him after he insisted on reporting to the FDA what he believed was misconduct at clinical trial sites in Russia and Bulgaria (back story). After the news broke, MannKind released a statement saying an independent investigator was hired to review the data, which is being gathered to support approval for the Afrezza inhaled insulin device, and that “there was no evidence of any deception or intent on the part of MannKind to deceive the FDA.” That leaves open the question as to whether Arditi spotted real fraud, although cfo Matt Pfeffer is quoted as saying the claims have... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4139478 Fri, 05 Nov 2010 15:32:21 +0100 4139478 http://www.medworm.com/index.php?rid=4134253&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQOHWDa0KH9k%2F Will this be a big step back for MannKind? A former MannKind exec has filed a lawsuit charging the drugmaker fired him in retaliation for alleging that scientific misconduct involving clinical trial data for the fledgling Afrezza diabetes drug was withheld from the FDA. The charges, which concern clinical trial sites in Russia and Bulgaria, were made by John Artidi, a former senior director for regulatory affairs, TheStreet writes. In the lawsuit, which was filed in a New Jersey state court two months ago, Arditi claimed he uncovered evidence of potential scientific misconduct at the sites and informed MannKind execs. At a site in Russia, for instance, he charged patients enrolled in the study had the same blood pressure readings at each visit for several months, but and so the finding cou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134253 Thu, 04 Nov 2010 22:05:33 +0100 4134253 http://www.medworm.com/index.php?rid=4134150&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F11%2F03%2Faccess-pharma-commences-european-phase-ii-study-of-prolindac%25e2%2584%25a2-paclitaxel-in-platinum-sensitive-ovarian-cancer-patients%2F Access Pharmaceuticals announces commencement of a Phase 2 combination trial for its second generation DACH-platinum cancer drug, ProLindac™ (formerly known as AP5346), in platinum-sensitive ovarian cancer patients. This trial is an open-label, Phase 2 study of ProLindac™ given intravenously with paclitaxel. The combination trial will be conducted in up to eight European participating centers. Access [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4134150 Thu, 04 Nov 2010 03:04:01 +0100 4134150 http://www.medworm.com/index.php?rid=4106061&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvbJfq4gqoWM%2F Two years ago, AstraZeneca halted a trial called Jupiter because its Crestor cholesterol pill outperformed a placebo. The study was undertaken to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk (back story). In doing so, however, the stoppage helped fuel a debate about the vagaries of halting trials before their time. In this video, Gordon Guyatt, an epidemiologist, biostatistician and professor of medicine at McMaster University discusses concerns that stopping trials early is done so to inflate efficacy and the implications of the Jupiter trial. This first appeared on Currrent Medicine TV. There is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106061 Mon, 25 Oct 2010 13:36:17 +0100 4106061 http://www.medworm.com/index.php?rid=4098466&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyYLEpWq3HvQ%2F When we talk about the placebo effect, the assumption is that the dummy pill is essentially identical to the real medication, but lacks the active ingredient. But what if that wasn’t so? What if the placebo contained something that might skew results? And how would anyone know if the the ingredients in a placebo are not disclosed? Which leads us to another question - should the contents be disclosed? A new study suggests the answer is yes. A paper published in the Annals of Internal Medicine found that some placebos may actually taint research. The authors reviewed 167 placebo-controlled trials published in medical journals in 2008 and 2009, and found placebo ingredients were rarely disclosed. In fact, only 8 percent of studies published in four top journals listed ingredients for pl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098466 Thu, 21 Oct 2010 13:06:18 +0100 4098466 http://www.medworm.com/index.php?rid=4082088&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcancer-prevention-how-to-sift-through-the-headlines%2F2010.10.19 Guest post submitted by MD Anderson Cancer Center Most of us can’t keep up with all the new ways to avoid cancer. Thanks to the Internet, we now have an unlimited supply of cancer knowledge at our fingertips. But, how can we filter out the good, the bad and the questionable? Below are steps to help you tease out the facts when reading that next big news story on preventing cancer. Says who? Don’t just take the writer’s word for it. Dig a little deeper to find out the source behind the hype. The American Cancer Society says you should ask yourself these questions when reading an article: Was this a press release from a company announcing a new breakthrough in cancer prevention? Was it a report from a clinical study that was given at a scientific conference? Was it a report from a st... Better Health blogs http://www.medworm.com/rss/comments.php?id=4082088 Tue, 19 Oct 2010 18:00:57 +0100 4082088 http://www.medworm.com/index.php?rid=4082291&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F10%2Fwhat-i-didnt-know-about-clinical-trials.html I had never really wondered when clinical trials started or how we got to where we are with a dysfunctional system. Between my two recent posts on thyroid cancer and long term side effects of medications, I was doing some research and found this article talking about the history of Synthroid or levothyroxine as it is named now. Then I found this timeline which shows how the FDA didn't have as much authority until 1988 - just over 20 years ago.I found several things surprising in this information:- Medical doctors recognized thyroid issues a long time ago - late 19th century but it took another 60 years before they had a medicine to replace it.- Some of the early medical treatments make my skin crawl - pig thyroids, vinegar, boiling oil, etc. YUCKY!- Synthroid or now Levothyroxine (it took ... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4082291 Tue, 19 Oct 2010 10:21:00 +0100 4082291 http://www.medworm.com/index.php?rid=4077538&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F10%2Fbackwards-medications.html Some medications act backwards - they cause the problem they are prescribed to prevent. So I think of them as backwards. A recent example of this is the drugs prescribed to prevent osteoporosis rarely cause degeneration of the jawbone or fractures of the thigh bone. In a nutshell, here is how my non-medical brain understands this: Drugs are okayed through clinical trials. There is increasing pressure to decrease the length of time of clinical trials to speed drugs to market (which is another post all together) - now I think of them as taking around 3-5 years of human tests. But then we have an aging population who is living longer with chronic conditions. Take the two together and we have populations who are taking prescriptions, or even OTC medications, for five times or more the length o... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4077538 Mon, 18 Oct 2010 10:57:00 +0100 4077538 http://www.medworm.com/index.php?rid=4077623&cid=t_91865_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F294%2Fmeaningful-beauty-cindy-crawford-skin-care-review%2F Meaningful skincare products are endorsed by Cindy Crawford, a former US supermodel who is getting a little older. The complete line includes cleansers, creams and masks.  Finding out about the ingredients has been difficult. Many cosmetic companies use advertising and celebrity endorsements to sell their products.  They might talk about the science behind the ingredients or the results we can expect to see after using them.  But they don’t want to give us a detailed list of ingredients until we physically pick up the product. Some companies are becoming less secretive about their products.  They realize that more and more consumers are concerned about safety.  It’s not just the people with allergies or sensitivities that worry these days. Scientists from around the world have exp... Skin MD blogs http://www.medworm.com/rss/comments.php?id=4077623 Sat, 16 Oct 2010 21:46:49 +0100 4077623 http://www.medworm.com/index.php?rid=4065570&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F10%2Fclinical-trials-research-vs-marketing.html So its not just what the clinical trials are about but also who is running them and who is paying for them that is important as well as why they are running the trials.The article uses an example of a Jenny Craig weight loss trial as their example but the point is true for any clinical trial. For many companies a clinical trial is important if it can get into one of the peer reviewed magazines where they trial gets a great deal of credibility in the medical/scientific world. A peer reviewed magazine has stringent requirements for including articles. They must not be marketing. They must not be sales. They must be scientifically or medically based and show a significant result. The articles are reviewed previous to publication by a 'peer' who is on the article's staff or is a consultant. Wh... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4065570 Thu, 14 Oct 2010 10:10:00 +0100 4065570 http://www.medworm.com/index.php?rid=4065471&cid=t_91865_117_f&fid=38158&url=http%3A%2F%2Fwww.twitter.com%2Famacupuncturehttp%3A%2F%2Famericanacupuncture.blogspot.com%2F2010%2F10%2Freporting-acupuncture-clinical-trials.html REPORTING ACUPUNCTURE CLINICAL TRIALS Finally acupuncture will be able to demonstrate its power and presence. The consolidated standard of reporting trials ( CONSORT) has been revised  since first published in 2001. In the revision,  has added  an extension for acupuncture.    Worldwide experts from 63 exquisite international references have supported this addition  after surveying 90  acupuncture trials.    These guidelines are a checklist and explanations for use by journal editors and authors. this should help peer reviewers and journal editors in deliberating the merits of the acupuncture trials  presented for publication.. Authors of acupuncture clinical trials, by executing these reporting standards,  will now have... Dr. Needles Medical Blogs blogs http://www.medworm.com/rss/comments.php?id=4065471 Thu, 14 Oct 2010 01:01:00 +0100 4065471 http://www.medworm.com/index.php?rid=4031439&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F10%2Fdoin-the-happy-dance.html After a lot of traveling and record gathering and anxiety and just general hassle: I GOT IT! I got the first dose of T-DM1 today, in Highland, and I will get it every three weeks hereafter.  Here's the funny part: My blood draw on Friday was the only thing I was worried about, and Dr. Ibrahim, the oncologist who heads up the trial,  doesn't work Fridays, it turns out, so he didn't get the results until this morning. When I arrived, Tricia, the trials coordinator, said we had to draw my blood again because the platelets were 90-something-thousand on Friday. And they needed to be 100,000, because the drug causes platelets to drop.  So we went down to the blood draw lab, escorted and expedited all the way by The Amazing Tricia, and they sent the blood out STAT an... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4031439 Tue, 05 Oct 2010 01:42:15 +0100 4031439 http://www.medworm.com/index.php?rid=4027319&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F10%2Fshow-them-money.html The price of prescription medications are appalling. I am sure drug companies do what all other manufacturers do in any areas - they have product managers who do research and look at costs and what the market will bear and set the prices. I look at my prescriptions. I personally take six prescriptions daily with another three for as needed. Of them, four are available in brand name only. This means they are newer drugs for which a generic has not yet been developed. Their copays make me cringe. Never mind their full price. I understand that it takes lots of development work to get one drug to market. Of hundreds that are worked on to one degree or another over years and years, a single drug final makes it through approval to market. The drug companies have to try to recoup some of the expe... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4027319 Sun, 03 Oct 2010 11:11:00 +0100 4027319 http://www.medworm.com/index.php?rid=4025741&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F10%2Fi-wasnt-going-to-break-this-news-until-next-week-.html In this study, known as TDM4370g or EMILIA, patients are randomized to receive either a control regimen or T-DM1; there is no cross-over to T-DM1 for patients in the control arm. "It is felt that continuing enrollment in T-PAS could interfere with the conduct of this study by potentially providing access to T-DM1 in the control arm, which could unfavorably impact the survival results of EMILIA. "Roche/Genentech's priority is the conduct of rigorous clinical trials to obtain full FDA approval of T-DM1 to ultimately provide T-DM1 access to more women in the future. Enrollment is not being discontinued for safety or efficacy reasons. Roche/Genentech remains committed to the ongoing development program for T-DM1." OK, but I am one of those women who has run out of options. ... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4025741 Sat, 02 Oct 2010 16:48:31 +0100 4025741 http://www.medworm.com/index.php?rid=4025742&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F10%2Fcancer-travel-sale-on-charmed-bracelets.html It looks like I will be flying from Seattle to Ontario, California, at least once every three weeks in order to get the cancer drug T-DM1 in a clinical trial.  I need to raise some money to help pay those expenses, and I've decided to start with a "Cancer Travel Sale" of earrings on Charmed Bracelets. See: Cancer Travel Sale   @ Jeanne Sather 2010.    (Source: The Assertive Cancer Patient) The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4025742 Sat, 02 Oct 2010 08:00:41 +0100 4025742 http://www.medworm.com/index.php?rid=4025743&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F10%2Fcontinuing-saga-.html It's Friday, six o'clock, and I'm waiting to see if Dr. Ibrahim will e-mail today to tell me if I am in the trial, or if I am going to have to wait till Monday to find out. I would, of course, so much rather get the results of all the tests today, because then I will know if I'm getting the first dose of T-DM1 on Monday, or not. "Not" will be reason for a major meltdown, as you can imagine. Today, Megan drove me to get an ECHO (which shows how well my heart is doing). All my past ECHOs in Seattle have shown a heart that is in surprisingly good shape for a woman who has had as much chemo, and as much Herceptin, as I have. So I'm not too worried about that one.  I also had blood drawn today to check a number of things, and I am a bit worried about that bec... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4025743 Sat, 02 Oct 2010 01:11:12 +0100 4025743 http://www.medworm.com/index.php?rid=4023090&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fwhere-can-you-get-t-dm1.html The government's clinical trials Web site (http://www.clinicaltrials.gov/ct2/show/NCT01120561) now lists 12 locations around the country where researchers are recruiting patients for a phase II trial of T-DM1, which they are now calling:  trastuzumab-MCC-DM1. These include: Highland, California; Stockton, California; Denver, Colorado; Davie, Florida; Chicago, Illinois; Lafayette, Indiana; Cedar Rapids, Iowa; Detroit, Michigan; St. Louis, Missouri; Charleston, South Carolina; Nashville, Tennessee; San Antonio, Texas; and Fairfax, Virginia.  Regardless of which location you choose, you have to pre-qualify first by calling this number: 888-662-6728. That's the trial information support line at Genentech.   Genentech has said it was going to open trials... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4023090 Fri, 01 Oct 2010 02:35:49 +0100 4023090 http://www.medworm.com/index.php?rid=4018440&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhZCO9RAOfvE%2F One of the big questions about establishing a regulatory pathway for approving biologics is the extent to which the FDA will require clinical trials to prove a biosimilar is equivalent to the original brand medicine. This is what is called the great unknown. But the FDA may have sent a signal about its thinking with a decision concerning a Teva Pharmaceutical drug. The FDA issued a Complete Response Letter to Teva, which has been seeking approval to sell a version of Amgen’s Neupogen, a med used to treat infections in people with certain types of cancer. In its press release, Teva notes the FDA “does not require additional pre-marketing clinical trials to complete the review” of the application. This is the part that is interesting, since Teva had submitted its applicatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018440 Thu, 30 Sep 2010 18:14:13 +0100 4018440 http://www.medworm.com/index.php?rid=4018446&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdQ15ZZGgQSU%2F Good morning, everyone. There is something of a downpour drenching the Pharmalot corporate campus, nonetheless, our spirits remain as sunny as ever. We hope you feel the same. Meanwhile, the time has come to indulge in another cup of stimulation. So please join us we ready ourselves for another day. Hope yours is a good one and catch you soon… Sanofi-Aventis & Covance Ink $2.2B, 10-Year Deal (Bloomberg News) Big Jump In Brand-Name Meds For Seniors In 2011: Study (The Hill) The Trials And Tribulations Of Malaria Vaccine Trials (Reuters) Pfizer Arthritis Drug Worked Too Well (Bloomberg News) Merck and AVEO End Collaboration On Lung Cancer Drug (Boston Globe) Most NIH-Registered Trials Use Sites Outside No. America (OutsourcingPharma) MediGene Cuts Workforce In Half (PharmaTimes) B... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018446 Thu, 30 Sep 2010 11:53:50 +0100 4018446 http://www.medworm.com/index.php?rid=4018394&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fthe-saga-continues-.html So, as you all probably know from my post the other day (See: Jeanne vs. Shingles: Jeanne Wins!), I did make the trip to the LA area to see Dr. Ibrahim at the Beaver Medical Group in Highland... I've spend the last two days getting a bone survey, a CT, a bone scan, and another test or two that I can't recall right now. However, due to a staff mess-up, one of the tests I needed had not been scheduled at all, and two more were booked for the same time on the same day at different facilities ... Fortunately, I felt like something was wrong on Tuesday when I was in seeing the trial coordinator, Tricia Ramos, about making sure the SCCA records dept. did fax the missing parts of my 12-year-cancer-history medical chart.  There was info in those early records that Dr. Ibrahim needed.... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4018394 Thu, 30 Sep 2010 10:03:55 +0100 4018394 http://www.medworm.com/index.php?rid=4013549&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkX2b8wnMUrA%2F Two years ago, a study called JUPITER looked at AstraZeneca’s Crestor cholesterol pill and measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. But the results prompted debate over the extent to which CRP should be used as a guidepost for treating cholsterol and prescribing Crestor and other statins to people with low cholesterol (see here). In June, a “critical reappraisal” appeared in The Archives of Internal Medicine calling the trial “flawed,” because there were various methodological problems and a “strong commercial interest” may have resulted in biased outcomes. Nine of 14 authors had ties to AstraZeneca and the principal investigator, Paul Ridker of Brigham and Women’s Hospital (pictured), is a co-holder of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013549 Tue, 28 Sep 2010 15:15:12 +0100 4013549 http://www.medworm.com/index.php?rid=4013550&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDsZNX7-Tasc%2F Responding to years of complaints that safety risks are being downplayed or ignored during the drug development process, the FDA has just issued a final rule for reporting safety information that crops up during clinical trials. This new rule requires certain safety info, which was was not required to be reported in the past, to be submitted within 15 days of when a drugmaker becomes aware of an issue. To wit, drugmakers must report findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions that occur at a rate higher than expected and serious adverse events from bioavailability studies which determine what percentage and at what rate a drug is absorbed by the bloodstream as well as bioequivalence studies tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013550 Tue, 28 Sep 2010 14:58:35 +0100 4013550 http://www.medworm.com/index.php?rid=4003391&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fjeanne-vs-shingles-jeanne-wins.html So, I went to Dr. Lee's office this morning to have my shingles checked, and Dr. Lee was not working today, so there was something of a shuffle to get me in to see one of the other doctors in the practice EARLY enough so that I could still make my flight, if the doctor OKed it ... I realized when I got up that I was going to have to prepare for both possibilities, so I packed my laptop bag with all the things I would need if I was hospitalized today for more aggressive shingles treatment, and I packed a separate bag with the clothes and toiletries I would need if I DID make the trip to S. California. My friend Laurie, who was driving me, was smart enough to point out that we needed (well, she needed) to load the wheelchair in the trunk because I would need it if I did fly. And I rememb... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4003391 Tue, 28 Sep 2010 05:14:20 +0100 4003391 http://www.medworm.com/index.php?rid=4003058&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fjeanne-vs-shingles-the-shingles-appear-to-be-winning.html As promised, I e-mailed Dr. Lee to let him know that I woke up this morning with a new set of red blotches, around my waist this time. They look the way the others did when they first appeared, so I am assuming that Dr. Lee is going to hospitalize me for three days to get the drug famciclovir by IV, which is what he said on Friday. Apparently the complications of shingles can be quite nasty, and my counts are still low. Also, it's not likely Dr. Ibrahim would give me the first dose of T-DM1 if I had an active shingles outbreak.  I was supposed to go to Dr. Lee's office by 10 tomorrow to get a GCSF shot, so I'm hoping he can take a look then. And write the orders for hospitalization, if necessary. I'm not changing my plane reservation or my appts. with Dr. Ibrahim'... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4003058 Sun, 26 Sep 2010 23:18:28 +0100 4003058 http://www.medworm.com/index.php?rid=4003067&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F09%2Ftransparency-credibility.html Regardless of one's political beliefs, with each change in presidency there is an ensuing change in the way decisions are made and published. During the previous administration, the tone of any decision was often 'that's it, take it or leave it'. With the current administration, there seems to be a bit more of explanation of the why's behind it. Who knows what the next administration will bring.In the meantime, the importance of clinical trials in FDA decision making is becoming more visible. And the openly published results and allowing for more discussion of the results and their meaning. This transparency allows for explanation of why the decision was reached but even more importantly it gives credibility. Instead of 'those bozos in Washington' type of thought process, we can learn how ... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=4003067 Sun, 26 Sep 2010 11:48:00 +0100 4003067 http://www.medworm.com/index.php?rid=4001776&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fwe-know-how-to-celebrate.html My friends and I know how to celebrate, that's for sure. After my appointment with Dr. Ibrahim at the Beaver Medical Group in Highland, the appointment during which he told me that if I could pass the various required tests and scans (the only one I'm worried about is blood counts) that I was IN THE TRIAL, I told Megan and Monica that I thought we needed to celebrate with the most delicious dessert we could find. Well, then there was some debate in the car, because it was 4:30 or 5 p.m. by this time, and Monica, a very healthy eater, said she needed some "real food," meaning dinner. But I pulled out that old (but loved) cliche, "Eat dessert first," and I won them over.  Megan suggested a gelato place not too far from her house. Monica loves gelato, and I h... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=4001776 Sat, 25 Sep 2010 19:50:29 +0100 4001776 http://www.medworm.com/index.php?rid=3999216&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fcitigroup-comes-through-.html Or, we could say in the headline, "Citi Does the Right Thing." And don't think that it wasn't because of all the letters you, my friends and readers, wrote, and of course the bigger, bolder posts at the top of my blog, that did the trick. Because they had ignored earlier posts on this blog--going back months--about how they weren't getting back to me, so it was the big deal we made out of my problem that got the attention of the right people, including the CEO, who is really tired of hearing from all of us. And "Citimortgage forecloses on dying woman" would make a very compelling headline. But I'll play nice here, and report that Citi gave me exactly what I asked for: a 12-month, no-pay (meaning no payments for 12 months) forbearance plan. I haven't ... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3999216 Fri, 24 Sep 2010 23:22:08 +0100 3999216 http://www.medworm.com/index.php?rid=3999219&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fdo-you-have-alaska-airlines-ff-miles-youd-be-willing-to-give-me.html I just returned from a trip to Beaver Medical Group for a consult with Dr. Ibrahim, who heads up the T-DM1 clinical trial there. The other purpose was to sign the consent documents, which I've ranted about before. (See: A Double Catch-22) As a result of that consult, my next step is to fly back to Ontario, California, on Monday next week. I'll spend two days getting tests and scans--from a blood draw, to an ECHO to check my heart, to about four more things. Well, maybe three more ... In any case, another friend had offered me her frequent flier miles on Alaska, but she doesn't actually have enough miles to cover the two tickets, one for me and one for my very-essential traveling companion. So if you have any miles you are willing to give away, please send me an e-mail. Th... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3999219 Fri, 24 Sep 2010 02:12:59 +0100 3999219 http://www.medworm.com/index.php?rid=3994343&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJSN3QSy3_u0%2F Good morning, folks. Another shiny day is emerging as we hustle the short people off to the local schoolhouse and busy ourselves with the news of the world. Speaking of which, the House passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud (take a peek). Now, though, the time has come for a cup of stimulation. Please join us, and have a great day… Merck Will Review Planned Facility Closing (Radio Netherlands) Perils For Pill Pushers (The Financial Times) FDA Finds Risk In Glaxo Rotarix Vaccine Data (Reuters) European Parliament Endorses Drug Monitoring Rules (PharmaTimes) Clinical Trials In Russia & Eastern Europe Fell In 2009 (OutsourcingPharma) Fake Avastin Hurts 61 People (Shanghai Daily) Abbott ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994343 Thu, 23 Sep 2010 12:03:27 +0100 3994343 http://www.medworm.com/index.php?rid=3994237&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Ffor-those-of-you-who-are-wondering-the-clinical-trial-is-looking-good.html Just a short note. I will try to write more tomorrow if I can find a WiFi spot at the airport. Monica and I are flying home tomorrow. So--I have a bunch of tests and scans that I have to pass, and if I do, then I'm in the trial and can get my first dose next week. The treatment appt. is already scheduled, actually. I will be flying down next week for the whole week. Longer, more detailed post tomorrow, I promise.      Jeanne   @ Jeanne Sather 2010. (Source: The Assertive Cancer Patient) The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3994237 Thu, 23 Sep 2010 07:54:11 +0100 3994237 http://www.medworm.com/index.php?rid=3994238&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fand-now-im-in-the-la-area-.html Hard to believe, but I was released from the hospital yesterday, and after less than 24 hours at home being spoiled by my dog, I had to leave again. I'm staying in Altadena with a woman I met through my blog who also has metastatic breast cancer, and tomorrow she will drive me to my appt. at the Beaver Medical Group in Highland.  I have both my fingers and my toes crossed that they will let me enroll in the trial. This is the only drug that my oncologist thinks might work for me. And my doctors' predictions that I will live another year are based on the assumption that I get T-DM1. The stakes are high here. Citigroup: Letter Writing Campaign The letter writing campaign seems to have gotten the attention of the right people at the company, including the CEO. So if you ar... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3994238 Wed, 22 Sep 2010 08:28:24 +0100 3994238 http://www.medworm.com/index.php?rid=3987199&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fim-home.html How many exclamation points are too many?  When I was in J School, we were taught to use exclamation points sparingly, and NEVER more than one per sentence. However, this homecoming, after six days at Northwest Hospital really deserves as many !!!!s as I can squeeze in. The best thing about being "sprung" was being outside in the fresh air, and it didn't hurt that the sun was shining. I had not breathed fresh air in six days. None of the windows I saw at the hospital--and certainly not the ones in my room--could be opened. The two best things about being on the oncology floor at NW Hospital, were (No. 1) the fantastic nurses and nursing assistants. Everyone who took care of me during my time there was warm and caring and competent, with the exception of one nursin... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3987199 Tue, 21 Sep 2010 03:10:32 +0100 3987199 http://www.medworm.com/index.php?rid=3987233&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF6ERgR5025Y%2F There is nothing like a story that tugs on the heart strings and forces reconsideration of an issue. Take the very sad tale of two close cousins from California who both developed melanoma - Tom McLaughlin landed in the experimental arm of a clinical trial for a Roche drug, PLX4032, while Brandon Ryan was chosen by computer lottery for the placebo. Their plight and the implications were detailed movingly in The New York Times. The central issue raised is whether a controlled trial for extending life is ethical. In this instance, PLX4032 was shown to shrink tumors in some patients, but only for a limited time, and the key question was whether those patients would live longer. The standard chemotherapy used in melanoma, dacarbazine, slowed tumor growth in 15 percent of patients for an averag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987233 Mon, 20 Sep 2010 14:37:26 +0100 3987233 http://www.medworm.com/index.php?rid=3983527&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fguess-where-i-am.html Unfortunately, I'm still hospitalized at Northwest Hospital in Seattle.  Some of the problems I came in with have not improved enough yet for me to go home, like my low blood counts (whites, reds, and platelets), my adrenal gland is not functioning on its own, and now I have shingles. (!!!!) That means I'm in an isolation room and my nurses have to gown and glove up every time they enter the room and then throw away the gloves and dump the gown in the laundry hamper as they leave my room. Anyway, emotionally I feel strong, and I am steadier on my feet and can walk a little bit, although I'm still supposed to take three walks a day using the walker, just up and down the halls.  I'll be getting two transfusions later today: whole blood and also platelets.  A... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3983527 Sun, 19 Sep 2010 21:28:32 +0100 3983527 http://www.medworm.com/index.php?rid=3983535&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F09%2Fdark-side-of-clinical-trials.html As I have noted before, the clinical trials process needs to be modified somehow to help reduce development costs for new drugs among other reasons. One of these reasons is the dark side of clinical trials, as I like to think of them. Clinical trials sometimes are the last resort for cancer patients. They hope what they are doing will help future patients. I think they often assume that because they are in a trial they are getting the new drug and it will have some miraculous effect on them. But that is not the case. Clinical trials are run as blind studies. Patients are randomized into different groups - two or three and sometimes more. One group gets the current standard in treatment that they are comparing the new drug to. The other groups get the new drugs or a combination of the new d... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=3983535 Sun, 19 Sep 2010 12:36:00 +0100 3983535 http://www.medworm.com/index.php?rid=3976650&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fgreetings-from-northwest-hospital-ii.html So, it is almost 2 p.m., and I have lost count of how many medical people I have seen today (Tomorrow I am going to take a head count.)  It's not that I don't need to see these people--the physical therapist was especially nice and taught me the RIGHT way to walk with my cane, get in and out of bed or a chair (although I was doing that fairly well) and how to walk with a walker. But I am so TIRED. Dr. Lee was one of the medical folks who came to see me today, and he had some answers, which was great. First, here's what's wrong with me: Because of all the decadron I took before and during all my radiation therapy treatments (four series of treatments some conventional, some cyberknife) I have something called decadron neuropathy. It is affecting my legs, and I can'... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3976650 Wed, 15 Sep 2010 21:09:27 +0100 3976650 http://www.medworm.com/index.php?rid=3973076&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fgreetings-from-northwest-hospital-ii.html So, it is almost 2 p.m., and I have lost count of how many medical people I have seen today (Tomorrow I am going to take a head count.) It's not that I don't need to see these people--the physical therapist was especially nice and taught me the RIGHT way to walk with my cane, get in and out of bed or a chair (although I was doing that fairly well) and how to walk with a walker. But I am so TIRED.Dr. Lee was one of the medical folks who came to see me today, and he had some answers, which was great.First, here's what's wrong with me:Because of all the decadron I took before and during all my radiation therapy treatments (four series of treatments some conventional, some cyberknife) I have something called decadron neuropathy. It is affecting my legs, and I can't st... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3973076 Wed, 15 Sep 2010 21:09:27 +0100 3973076 http://www.medworm.com/index.php?rid=3965527&cid=t_91865_113_f&fid=38494&url=http%3A%2F%2Fcuretogether.com%2Fblog%2F2010%2F09%2F13%2Fnew-study-low-dose-naltrexone%2F Life science research should be transparent. This is exciting news. CureTogether is partnering with Transparency Life Sciences to run a trial on Low-Dose Naltrexone (LDN). Read the letter below for details. “Dear CureTogether and LDN community members, If you use or prescribe Low-Dose Naltrexone, we would like to invite you to share your experience and be part of a new kind of participatory research. LDN is currently used “off-label” by thousands of patients worldwide who are inconvenienced and frustrated by the lack of regulatory and marketing authorization of this medication. A start-up drug development company, Transparency Life Sciences (TLS), is interested in performing open clinical trials on LDN for several conditions, if we get enough interest from patients,... The Collective Well blogs http://www.medworm.com/rss/comments.php?id=3965527 Mon, 13 Sep 2010 19:00:16 +0100 3965527 http://www.medworm.com/index.php?rid=3958031&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Ft-dm1-going-to-la.html I have an appointment in Highland, California (an L.A. suburb), on September 22 for a consult with the doctor who is heading up the T-DM1 clinical trial there. I've already jumped through a lot of hoops to qualify for this trial, so once I have the consult and sign all the consent documents, then we'll schedule me for another visit to get a bunch of tests and scans, and then after that I will start getting the drug, once every three weeks, by IV.I had been hoping to enroll in a branch of the trial at the University of Washington, which is right down the street from my house, but that trial has been delayed, delayed, delayed. I can't wait any longer--I have tumors growing all over my body, and we need to get them under control. So it looks like I will be The Co... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3958031 Fri, 10 Sep 2010 18:37:47 +0100 3958031 http://www.medworm.com/index.php?rid=3946655&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fwww.phsa.ca%2FNR%2Frdonlyres%2F825EDD83-D53B-433C-8012-C7737B89CA50%2F0%2FHuntsmanedit.mp3 British Columbian researchers discover that approximately one-half of clear-cell ovarian cancers and one-third of endometrioid ovarian cancers possess ARID1A gene mutations, as reported today in the New England Journal of Medicine. British Columbian researchers discover that approximately one-half of ovarian clear-cell cancers (OCCC) and one-third of endometrioid ovarian cancers possess ARID1A (AT-rich interactive domain 1A [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=3946655 Thu, 09 Sep 2010 01:28:12 +0100 3946655 http://www.medworm.com/index.php?rid=3946690&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhQAvUYTu_zk%2F Hello, everyone, nice to see you again. A sunny day is dawning here on the Pharmalot corporate campus, where the short people are off to the schoolhouse for another year of adventure and, hopefully, a little learning. While we ponder the possibilities, please join us for another cup of stimulation and a quick scan of the news of the world. Hope your day goes well… Glaxo Hires Goldman Sachs Banker as CFO (Reuters) Business Confidence Is Higher In Pharma Sector (PharmaTimes) Biovail And Valeant Merger To Increase Layoffs (The Globe & Mail) Teva & Baxter Must Pay $365M To Man Infected With Hepatitis C (Ha’aretz) Clinical Trials Initiated In South Korea Rose 150% Since 2006 (OutsourcingPharma) Shanghai Pharma Plans $1.2B IPO (Reuters) Glaxo And Lonza Sign Development Deal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946690 Wed, 08 Sep 2010 12:00:05 +0100 3946690 http://www.medworm.com/index.php?rid=3933265&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaKrQUrCNzEU%2F Good morning, everyone. How are you today? Slowing down just a bit, perhaps? Here in the states, of course, a three-day weekend is fast approaching. And so we will pull in the sidewalks early. We hope you have the opportunity to do the same. Meanwhile, here are a few nuggets to help you close out the week. Whatever you do over the next few days, may it be enjoyable. Cheers… Celldex Says Pfizer Ends Cancer Vaccine Deal (Reuters) Allergan Steps Up Overseas Clinical Trials (CBS News) Novartis Experimental Malaria Drug May Be First In 30 Years (Bloomberg News) Abbott Cancels Sale Of Solvay Vaccines Unit (The Wall Street Journal) Accenture And ICRI Partner On Indian Clinical Research Training (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3933265 Fri, 03 Sep 2010 12:02:08 +0100 3933265 http://www.medworm.com/index.php?rid=3929426&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F09%2Fi-need-some-time-off.html Yesterday I had the final-final cyberknife treatment, to kill the tumor in my sixth rib on the right side.    Over the past several months I have had huge doses of radiation--four separate series of treatments--and I'm beginning to understand the term "radiation sickness," usually applied to the hibakusha who survived the bombings of Hiroshima and Nagasaki.  Not to get too dramatic about the whole thing, but my body has taken a major beating, and now I need to heal. Part of that will be simply doing less, every day, until my energy rebounds. As a result, I won't be online much for the next week or so, and I will be skimming through my e-mail, but not answering most of it. Sorry.  I spent several hours working in my garden this morning, with the fai... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3929426 Thu, 02 Sep 2010 22:15:10 +0100 3929426 http://www.medworm.com/index.php?rid=3925084&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHa5z-LE_Be8%2F After a decade of running one of the world’s most prestigious medical journals, Catherine DeAngelis is leaving her job as editor-in-chief of the Journal of the American Medical Association next year to join Johns Hopkins University School of Medicine, Baltimore, where she will develop a Center for Professionalism in Medicine and the Related Professions, including nursing, public health, business and law. “This program, based in ethical professional conduct, will be a culmination of education, training and experience. It is the logical next step for me based back in my academic home,” DeAngelis says in a statement, which notes she was vice dean for Academic Affairs and Faculty at Hopkins School of Medicine before going to JAMA and is a professor of pediatrics there. During her te... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925084 Wed, 01 Sep 2010 22:45:53 +0100 3925084 http://www.medworm.com/index.php?rid=3925055&cid=t_91865_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F09%2F01%2Fu-s-president-barack-obama-proclaims-september-2010-as-national-ovarian-cancer-awareness-month%2F Yesterday, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month.  During National Ovarian Cancer Awareness Month, we honor all those lost to and living with ovarian cancer, and we renew our commitment to developing effective screening methods, improving treatments, and ultimately defeating this disease. The White House Office of the Press [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=3925055 Wed, 01 Sep 2010 15:36:36 +0100 3925055 http://www.medworm.com/index.php?rid=3921075&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0FVhG6k4V6A%2F Drugmakers regularly complain that it is getting more difficult and more expensive to recruit people into clinical trials, hence the rush overseas (background here and here). So how should a drugmaker or clinical research organization entice prospective participants? A new survey finds some companies succeed by simply appealing to the need people have to receive an otherwise unavailable treatment, or to a feeling of altruism. But let’s get down to the numbers: as the chart indicates, the most effective pitch is offering a treatment that represents an improvement, following by the convenience of the trial site, the prospect of receiving a free med, tinkering with the number and frequency of site visits and a short trial duration, according to the survey from CuttingEdge Information, w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921075 Tue, 31 Aug 2010 12:49:14 +0100 3921075 http://www.medworm.com/index.php?rid=3915242&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F08%2Fmore-in-t-dm1.html Well, as a woman with advanced breast cancer who HAS RUN OUT OF TREATMENT OPTIONS, I have to disagree with Breast Cancer Action on this one. See the letter re: T-DM1: T-DM1 Breast Cancer Action Letter I understand the arguments the group advances, I even agree with them up to a point. But the whole approval process is incredibly long and cumbersome, and getting drugs outside that process--despite what you might think when you hear the term "compassionate use"--is almost impossible, in my experience. As I said in an earlier post, I don't think this will hurt my ability to get the drug in a Phase II trial. There is a trial opening here in Seattle soon, unless this news somehow makes the folks at the UW less enthusiastic about getting the trial through their ow... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3915242 Mon, 30 Aug 2010 17:28:48 +0100 3915242 http://www.medworm.com/index.php?rid=3915286&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP96r1KXl_cQ%2F Just how useful are non-inferiority trials? For the uninitiated, such trials compare a drug being developed with one that is already approved by the FDA. Drugmakers, of course, pursue such studies so they can show their new med is no worse than another, and may even show some benefits. But this approach has generated criticism - why approve a new drug when an existing med does the job? There is also concern about ‘biocreep.’ This refers to concerns that successive generations of drugs that are approved based on non-inferiority trials can lead to less effective drugs over time, including those that are, ultimately, no more effective than a placebo. And so after a request from several members of Congress, the General Accountability Office has issued a new report that indicates th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915286 Mon, 30 Aug 2010 13:28:47 +0100 3915286 http://www.medworm.com/index.php?rid=3915256&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F08%2Fits-nice-to-knowim-not-only-one.html Recently I have written (or blabbed or bored you) about clinical trials and the drug approval process and how (un)happy I am with it at times where they approve drugs and then withdraw them. Well, it turns out, I am not the only one. There was an article this morning where a doctor at Children's Hospital in Boston discusses possible flaws in the drug approval process. But she also has some plausible solutions for changing the process - and says we aren't there yet. So I'll go on with my fingers crossed that nothing I take will be recalled. But its Monday morning and I have my forgotten radiation oncologist follow up first thing. Somehow I will be incredibly busy in the next two weeks. Why do I do these things to myself? I have four doctor appointments, two meetings, two big work deadlines,... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=3915256 Mon, 30 Aug 2010 10:09:00 +0100 3915256 http://www.medworm.com/index.php?rid=3913263&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F08%2Ft-dm1-news-.html I'm not sure what this news item about T-DM1 means for me, if anything. T-DM1 is the new drug that I plan to get in a clinical trial once I've finished my current cyberknife treatments. I think it's the right drug for me--pretty much the only drug, really--and there is a trial opening at the UW/SCCA soon (although THAT is held up in a committee, I'm told). In any case, the drug maker failed to win "accelerated approval" for T-DM1, "because all available treatment choices for metastatic breast cancer ... had not been exhausted."Well, here is one woman for whom all options HAVE been exhausted. But I'm not going to panic, because I don't think this news affects the clinical trial, but it might affect how soon the drug is available outsid... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3913263 Sat, 28 Aug 2010 21:29:57 +0100 3913263 http://www.medworm.com/index.php?rid=3903128&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqnjGj73YNLM%2F A new study in Pediatrics finds more pediatric trials are going overseas - 65 percent conducted under the pediatric exclusivity provision, which offers drugmakers six months of patent extension for running safety and efficacy studies - used overseas sites. More than one-third, or 38 percent, enrolled patients in a developing country, including one-third of trials testing infectious disease, cardiovascular and allergy and immunology meds. And 11 per cent only used sites outside the US (here is the abstract). “There are potential benefits to the globalization of pediatric research, such as reducing the cost and time line for drug development, fostering global clinical innovation, and improving access to therapies and the health of children worldwide,” says Sara Pasquali, the study’s l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3903128 Wed, 25 Aug 2010 15:27:29 +0100 3903128 http://www.medworm.com/index.php?rid=3896055&cid=t_91865_136_f&fid=35303&url=http%3A%2F%2Fwww.assertivepatient.com%2F2010%2F08%2Fback-to-the-cyberknife.html Today is the first of five treatments in my third series of cyberknife procedures.  OK, let's stop and think about that for a minute ... In January, I had a series of five treatments to my skull. There was a tumor there that was pressing on a nerve that controlled my tongue. It was the first tumor I've had north of my collar bone, ever, and so it got my--and my doctors'--special attention.  Important to note, however, that this was NOT a brain tumor. Just another "bony lesion," as they say in my reports.  Then, in early August, I had a series of three cyberknife treatments to zap a tumor in my spine that was moving in on the spinal cord. See: Very Quick Update That series was, I am happy to report, uneventful. No problems, no side effects... The Assertive Cancer Patient blogs http://www.medworm.com/rss/comments.php?id=3896055 Mon, 23 Aug 2010 18:23:30 +0100 3896055 http://www.medworm.com/index.php?rid=3885343&cid=t_91865_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Favastin-for-breast-cancer-will-the-fda-revoke-it%2F2010.08.19 Time to get back up on my soap box. Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month. The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing. Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other c... Better Health blogs http://www.medworm.com/rss/comments.php?id=3885343 Thu, 19 Aug 2010 20:00:00 +0100 3885343 http://www.medworm.com/index.php?rid=3880973&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F08%2Falzheimers-disease-rethinking-things.html A very readable piece from Gina Kolata of the New York Times:Doubt on Tactic in Alzheimer’s BattleBy GINA KOLATAThe New York TimesPublished: August 18, 2010"The failure of a promising Alzheimer’s drug highlights the gap between diagnosis and treatment."Read the full article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=3880973 Wed, 18 Aug 2010 22:40:00 +0100 3880973 http://www.medworm.com/index.php?rid=3868714&cid=t_91865_87_f&fid=34470&url=http%3A%2F%2Fwww.thehealthcareblog.com%2Fthe_health_care_blog%2F2010%2F08%2Fcan-health-20-fix-clinical-trials.html By Matthew Holt Saturday's New York Times portends more trouble for big Pharma. The headline is wrapped up in an examination of foreign corrupt practices, but the bigger issue is that clinical trials have hidden serious adverse events. The recent... (Source: The Health Care Blog) The Health Care Blog blogs http://www.medworm.com/rss/comments.php?id=3868714 Sun, 15 Aug 2010 23:00:00 +0100 3868714 http://www.medworm.com/index.php?rid=3865422&cid=t_91865_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F08%2Fahem-could-this-be-skewing-of-clinical.html Well, not the actual data but the releasing of the data. It turns out that more industry funded trials have better results than those run by non profits or government agencies. Then we learn that results of many trials are not made public, even into standard medical databases. So if we take fact one that industry seems to be better at running clinical trials at face value - maybe its just because they are better at running trials since they developed the drugs or whatever. Then we take fact two that trial results don't always see the light of day. This has nothing to do with whether a drug is approved or not, the FDA takes the trial results and goes from there. It seems that non-industry run trial results, the ones that are less likely to be full of as many positives, are less likely to be... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=3865422 Fri, 13 Aug 2010 11:21:00 +0100 3865422 http://www.medworm.com/index.php?rid=3862101&cid=t_91865_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2010%2F08%2Fpotiga-ezogabine.html From FierceBiotechFDA panel backs new epilepsy drug from GSK, ValeantAugust 12, 2010 — 7:41am ET By John Carroll"GlaxoSmithKline and Valeant got a solid endorsement for their new epilepsy drug Potiga (ezogabine) from the FDA's panel of experts, putting them on track to a likely approval. The experts unanimously agreed that the drug would benefit epilepsy patients whose meds couldn't stop seizures. And they agreed that careful monitoring would flag patients who experience an inability to urinate while taking the drug."Read the full article (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=3862101 Thu, 12 Aug 2010 17:17:00 +0100 3862101 http://www.medworm.com/index.php?rid=3862189&cid=t_91865_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXaZa343693Q%2F Why do some people volunteer for clinical trials? Are they aware of the risks? Are they treated properly? What kind of follow up should take place? These are among the issues that Roberto Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York and a PhD in anthropology, explored in a new book, ‘The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects.’ He would like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws. And he favors the creation of a national registry of Phase 1-trial participants, which prevent people from participating in too many trials and help researchers identify long-term adverse effects associated with certain trials... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3862189 Thu, 12 Aug 2010 13:59:23 +0100 3862189 http://www.medworm.com/index.php?rid=3845282&cid=t_91865_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