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 'accelerated'. Sat, 03 Sep 2011 02:23:04 +0100 http://www.medworm.com/index.php?rid=4992990&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLVsy771S9hA%2F The FDA may want to yank the breast cancer indication for Avastin, but the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage. “As long as doctors continue to prescribe it, we will continue to pay, even for an off-label use, until and unless some time in the future we decide to change our coverage policy. We have no such thing underway at this time,” a CMS spokesman tells us. “We often pay for off-label use of drugs, but not always.” The move will, no doubt, cheer many breast cancer patients and their loved ones, who feared the FDA would soon put Avastin out of reach (look here), now that an agency advisory panel unanimously voted - once again - to rescind the indication. The vote came earlie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992990 Fri, 01 Jul 2011 16:36:13 +0100 4992990 http://www.medworm.com/index.php?rid=4984687&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8Pxx2sLGKGM%2F After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, there were behind-the-scenes debates over potential conflicts of interest among expert speakers, and patients and their families organized protests - online and in person. Clearly, more was at stake than the fate of a best-selling med, which remains available for treating other cancers. The hearing was also a referendum of sorts on the veracity of the FDA accelerated approval program and, by extension, the agency itself. We asked Daniel Carpenter, the Allie S. F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984687 Thu, 30 Jun 2011 12:45:07 +0100 4984687 http://www.medworm.com/index.php?rid=4984690&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnPwCL76CH9s%2F Concluding a rare, two-day hearing, an FDA panel has voted 6-to-0 to revoke the breast cancer indication for Avastin, dealing a huge blow to Roche and its Genentech unit, which now stand to lose an estimated $1 billion in annual sales. The drugmaker had appealed a decision last December by the agency to yank the indication, prompting a heated debate over the veracity of the FDA accelerated approval program. A final decision, however, rests with FDA commish Margaret Hamburg. Meanwhile, the FDA and Roche’s Genentech unit will provide additional written submissions by July 28, and the docket will remain open for public comment until then (see this). At the conclusion of the meeting, some patients were particularly vocal. “What do you want us to take!? We have nothing else!” shouted ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984690 Wed, 29 Jun 2011 20:07:35 +0100 4984690 http://www.medworm.com/index.php?rid=4704954&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNe6vaqZAGEo%2F Despite weeks of haggling, Roche and the FDA remain unable to agree on the questions that must be addressed during the upcoming June hearing that will be held to decide whether the agency will proceed with plans to remove the metastatic breast cancer indication for the Avastin. The two sides are so far apart, in fact, that each one has submitted separate documents summarizing their differing views of the key questions to be addressed. Some quick background: The FDA decided to yank the breast cancer indication after results of four clinical studies showed that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; devel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704954 Tue, 12 Apr 2011 16:31:32 +0100 4704954 http://www.medworm.com/index.php?rid=4693505&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1ht08wD4WlQ%2F The run-up to what will be a closely watched FDA meeting this coming June to review the Avastin cancer med is prompting some interesting behind-the-scenes sparring between the agency and Roche. To wit, in a recent letter to different FDA officials, Covington & Burling attorney Michael Labson, who represents Roche’s Genentech unit, accused the FDA Oncologic Drugs Advisory Committee of bias. Why? In his view - and obviously, the view of the drugmaker - there are concerns about “objectivity and fairness.” To underscore this contention, Labson writes in his March 10 missive that nearly all members of the committee last July voted to withdraw FDA approval for the metastatic breast cancer indication for Avastin (back story). And since then, various committee members were q... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693505 Fri, 08 Apr 2011 13:26:24 +0100 4693505 http://www.medworm.com/index.php?rid=4642994&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCNw4FaSlyn0%2F To prompt drugmakers to follow through more quickly on post-marketing studies required as part of the controversial acceleted approval program, several FDA officials suggest the agency make use of an existing provision of a 2007 law - issuing fines of up to $10 million. And the FDA may also require post-marketing studies get under way before expedited approval is granted, according to agency officials who floated the possibilities in a new article in the Journal of the National Cancer Institute. The tougher approach for oncology meds is being considered in the wake of considerable handwringing after two episodes last year that questioned the veracity of the FDA accelerated approval program. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642994 Mon, 28 Mar 2011 15:46:53 +0100 4642994 http://www.medworm.com/index.php?rid=4455482&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuEu4Ajq_SyY%2F In 2005, AstraZeneca ran into a problem with its Iressa cancer drug, which had been approved two years earlier to treat non-small cell lung cancer as part of the FDA accelerated approval program. This meant the drugmaker was required to conduct so-called confirmatory studies, but the follow-up failed to show a survival benefit and Iressa was withdrawn, except for patients already being treated. In fact, this turned out to be the first of five instances in which such follow-up trials flopped and a drug was subsequently yanked or new restrictions were imposed. This was a distinction that, no doubt, AstraZeneca would like to forget. Of course, the drugmaker was not helped after receiving reports of serious illness and deaths due to a lung disease associated with the med in Japan. However, con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455482 Wed, 09 Feb 2011 22:11:48 +0100 4455482 http://www.medworm.com/index.php?rid=4455484&cid=t_167350_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=4322692&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZwTtD0ctKmk%2F The debate over the breast cancer indication for Avastin was one of the more highly charged issues last year. After clinical studies revealed the Roche med did not prolong overall survival and caused serious side effects, an FDA panel recommended withdrawing approval. To the applause of some consumer advocates (see here), the agency last month took that step, even though many breast cancer patients urged the FDA to preserve an option they say worked for some people (look at this). After deciding to unravel the indication, however, the FDA was criticized by Republicans for using cost as a reason - the treatment carries a price tag of about $80,000 a year - amid growing concern that healthcare rationing is becoming an issue for regulators. Now, however, Richard Pazdur, who heads the FDA&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322692 Fri, 07 Jan 2011 14:37:39 +0100 4322692 http://www.medworm.com/index.php?rid=4266266&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBvkC4XWP9nc%2F After months of anticipation, the FDA has started the process of removing the breast cancer indication for Roche’s Avastin med, dealing a huge setback to the drugmaker. The decision comes after months of intense debate over the merits of such a move and is estimated to cost Roche about $1 billion in annual sales. Roche plans to appeal in hopes of being granted a hearing. The European Medicines Agency, meanwhile, is not taking the same step. In explaining their decision, FDA officials cited the results of four clinical studies and determined the data indicate Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266266 Thu, 16 Dec 2010 16:48:27 +0100 4266266 http://www.medworm.com/index.php?rid=4045095&cid=t_167350_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fsex-and-your-defibrillator%2F2010.10.08 Have a defibrillator and feel like getting frisky? For the first time that I can recall, there’s a very helpful article published in Circulation addresses the concerns of implantable cardiac defibrillator (ICD) patients and sexual activity. There’s all kinds of helpful tidbits, like this one: A study of 1,774 patients who had experienced an acute myocardial infarction showed that sexual activity was a likely contributor in fewer than 1 percent of cases. In fact, regular physical exertion, such as that associated with sexual activity, was associated with a decreased risk of cardiac events in patients. Now that’s helpful! Recall that defibrillators are designed to detect rapid, potentially life-threatening arrhythmias. Most of the time, sexual activity does not lead to hea... Better Health blogs http://www.medworm.com/rss/comments.php?id=4045095 Fri, 08 Oct 2010 14:00:00 +0100 4045095 http://www.medworm.com/index.php?rid=4003260&cid=t_167350_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FjKy0g36IhNs%2F Can you correctly interpret the ECG findings in a marathon runner with gastroenteritis? What is their significance? What management is required? (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4003260 Tue, 28 Sep 2010 00:00:31 +0100 4003260 http://www.medworm.com/index.php?rid=3969184&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7rGeUjUn5rM%2F Last month, an FDA advisory committee voted 12 to 1 to recommend the agency withdraw approval for the multi-billion-dollar Avastin cancer drug to be used to treat breast cancer. The move came after two recently released studies - which were undertaken as a condition of approval - found that patients given Avastin and chemotherapy didn’t survive longer than those given chemo alone. And Avastin patients also suffered more serious side effects. Two years ago, an FDA panel voted against approval (see here), but the agency endorsed treatment for breast cancer anyway. And later this week, the FDA is expected to decide again what to do about the breast cancer indication for the drug, which is already approved to treat colon, lung and brain cancer. The impending decision is sparking heated debat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3969184 Tue, 14 Sep 2010 13:32:32 +0100 3969184 http://www.medworm.com/index.php?rid=3915285&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJhu1W0Nq_XU%2F In a surprising move, the FDA late last week issued a Refuse to File letter to Roche’s Genentech unit for its T-DM1 biologic, which is being developed to treat women who have advanced breast cancer, test positive for the HER2 protein and hadn’t responded - or stopped responding - to other meds, including Roche’s Herceptin. The decision is a blow after the drugmaker trumpeted T-DM1 as an important salve - not only for women - but also as a way to extend its breast cancer franchise. The agency action came as a surprise, because the FDA explained not all treatment choices had been included in the single-arm, Phase II trial that was used as the basis for the Genentech application (see here). It was only last month that Genentech filed its application, noting T-DM1 shrank tumo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915285 Mon, 30 Aug 2010 14:26:39 +0100 3915285 http://www.medworm.com/index.php?rid=3915289&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhuv0ECHQp-M%2F The drugmaker recently discussed cutbacks at a management meeting and the number of jobs being considered for elimination are expected to be in the thousands, and come not only from sales and marketing, but also research and development and pharma administration, according to the Swiss newspaper, Sonntag. “This will not only concern a few hundred people but many more. And the job cuts will not be made in one single country but on a worldwide scale,” the paper quoted one source, who also indicated the announcement will be made this week, although a Roche spokesperson tells Reuters that no decision will be made that soon. “We are always working to improve productivity and will continue to do so. But it is too early to speculate on potential job cuts,” Reuters reports... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915289 Mon, 30 Aug 2010 12:15:24 +0100 3915289 http://www.medworm.com/index.php?rid=3885343&cid=t_167350_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=3772462&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLzIE6gpetxY%2F An FDA advisory committee dealt a huge setback to Roche by voting 12 to 1 to recommend the agency withdraw approval for the multibillion-dollar Avastin cancer drug to be used to treat breast cancer. Avastin should generate $6.5 billion in sales this year, with about $1.2 billion coming breast cancer usage, according to Sanford Bernstein analyst Tim Anderson. Unless, of course, the agency revokes the breast cancer indication. Avastin, by the way, is the first med to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis. It targets a chemical signal known as vascular endothelial growth factor, or VEGF. The med is also approved for brain, lung and colon tumors, and costs about $50,000 a year. The panel vote may raise further questions about the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772462 Tue, 20 Jul 2010 22:08:48 +0100 3772462 http://www.medworm.com/index.php?rid=3772467&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcFuL0NnhnWQ%2F Two years ago, the FDA approved Avastin to combat breast cancer, even though an advisory panel determined that risks such as high blood pressure and death outweighed the benefit of slowing the spread of tumors. The agency, however, acted under its accelerated approval program and the move pumped up sales of a Roche drug that is also used to treat brain, lung and colon tumors. Now, though, Avastin is on trial again. Another FDA panel today will decide whether use of the $50,000-a-year med should be continued, expanded, or halted after two studies - which were undertaken as a condition of approval - found patients given Avastin and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients also suffered more serious side effects. This is the second time in re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772467 Tue, 20 Jul 2010 14:02:57 +0100 3772467 http://www.medworm.com/index.php?rid=3742249&cid=t_167350_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ftea-brewed-from-angels-trumpet-causing-hospitalizations-in-kids%2F2010.07.10 Toxicity reports are re-emerging in southern California this week after a dozen hospitalizations of kids using teas made from a fragrant flowering plant called Angel’s Trumpet. A tea made from the plant is used to produce hallucinations, but they can progress to extremely unpleasant experiences. Moreover, Angel’s Trumpet can be deadly, accelerating the heart rate and causing fatal cardiac rhythmic disturbances and bronchoconstriction that can trigger asthma attacks in sensitive individuals. (more…) *This blog post was originally published at Terra Sigillata* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3742249 Sat, 10 Jul 2010 12:00:59 +0100 3742249 http://www.medworm.com/index.php?rid=3687359&cid=t_167350_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ8SscvbYqOI%2F The decision to withdraw Mylotarg, a drug used to treat acute myeloid leukemia, or AML, is more significant for the FDA than for Pfizer, which garnered about $100 million in worldwide sales from the medicine. That’s because the drug was approved in 2000 as part of the accelerated approval process. As the FDA explained when announcing the withdrawal: “This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.” The program was an outgrowth of criticism that the agency wasn’t moving fast enough to approve new drugs, especially... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3687359 Tue, 22 Jun 2010 12:03:13 +0100 3687359 http://www.medworm.com/index.php?rid=3089288&cid=t_167350_87_f&fid=38368&url=http%3A%2F%2Fsabin.org%2Ffiles%2Fattachment%2Fvalue_vaccination_bloom_canning_weston.pdf The following post by Lois Privor-Dumm, IMBA, Director of Alliances and Information for the PneumoADIP at Johns Hopkins Bloomberg School of Public Health, is part of Disruptive Women’s “The Value of Health: Creating Economic Security in the Developing World” series. Lois heads up several vaccine projects related to advocacy and communications as well as access and implementation. She is currently working as Director, Large Country Introduction for the Accelerated Vaccine Introduction Technical Assistance Consortium (AVI TAC), a GAVI-funded project with an aim to accelerate introduction of pneumococcal and rotavirus vaccines in low-income countries. Lois has been at Johns Hopkins since 2005 helping guide strategies and accelerated uptake on both the Hib Initiative and Pneu... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3089288 Tue, 15 Dec 2009 14:03:19 +0100 3089288 http://www.medworm.com/index.php?rid=1531084&cid=t_167350_125_f&fid=34820&url=http%3A%2F%2Fwww.dentalblogs.com%2Farchives%2Fadministrator%2Fwilckodontics-with-human-bone-grafting-accelerates-ortho-for-dental-patients%2F Periodontist Tom Wilcko developed Wilckodontics, a method of orthodontics that repositions teeth more quickly than traditional methods. The Wilckodontics website claims that patients can be “in and out of braces in 3 to 8 months.” The procedure, intended for adults with mature bone tissue, involves PAOO, Periodontally Accelerated Osteogenic Orthodontics. In short, the jawbone is scored and a bone graft applied to the area. This softens bone to allow for accelerated movement of teeth into their ideal position. The entire procedure is done under local anesthetic and performed by an oral surgeon or periodontist. A recent University of Southern California School of Dentistry study shows that by using the patient’s bone for the graft, the potential for disease transmission is ... dental blog for dentists about dentistry blogs http://www.medworm.com/rss/comments.php?id=1531084 Fri, 20 Jun 2008 13:29:14 +0100 1531084 http://www.medworm.com/index.php?rid=1191350&cid=t_167350_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F01%2F31%2Fis-having-depression-or-bipolar-an-advantage%2F Philip over at Furious Seasons has a great interview with author Tom Wootton about his two books, The Depression Advantage (2007) and The Bipolar Advantage (2005). These are two self-help books that use “accelerated learning techniques [the author] developed as a corporate consultant to Fortune 500 companies” (according to the Amazon blurb). The Amazon reviews are worth the read, as some readers have some reservations about the author. It’s an interesting interview and the author makes a very important point that we often see lost in the conversation about coping with long-term depression or bipolar disorder. You can learn important lessons from dealing with adversity, which includes any adversity in our lives. I’m not sure I buy into the idea that having a serious... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1191350 Thu, 31 Jan 2008 19:40:37 +0100 1191350 http://www.medworm.com/index.php?rid=828181&cid=t_167350_132_f&fid=35011&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fmndoci%2F%7E3%2F149497121%2F Interested in Accelerated Computing? Do you use FPGA’s or other novel architectures for scientific computing? You have to read this post (and comments) on the Accelerated Computing meme by Joe Landman and another where he talks about the future of high performance computing. I’ve always struggled with the role of accelerators for scientific computing. The geek in me loves the concept, but as raw processing power in computers has improved, the sheer convenience of clusters, and increasingly of computing out in the cloud just seems more appealing. At some point though, we will hit the architecture limits that Joe talks about. What kind of architectures will we be using then? Will we have to rewrite all our code? These are just some of the questions that will need to be answered b... business|bytes|genes|molecules blogs http://www.medworm.com/rss/comments.php?id=828181 Wed, 29 Aug 2007 04:59:52 +0100 828181