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 'actonel'. Sat, 03 Sep 2011 02:36:21 +0100 http://www.medworm.com/index.php?rid=5051241&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNb6v9O_OLc8%2F Being blinded by science is something of a preoccupation these days and so less than a year after dueling studies reached differing conclusions that oral bisphosphonates are linked to esophageal cancer, the FDA has weighed in and - for now - declared that no such risk exists. However, the agency cautiously noted no risk was found “at this time” and its review is ongoing. In reaching its preliminary decision, the FDA reviewed two epidemiologic studies - one reviewed the UK General Practice Research Database and found no increase in the risk of esophageal cancer (see this). The second study found a doubling of the risk among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over three years (read more here and here). The drugs, by the way, are use... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051241 Thu, 21 Jul 2011 17:48:39 +0100 5051241 http://www.medworm.com/index.php?rid=4065617&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8k65uV-jRqU%2F Good morning, folks, and nice to see you again. This will be an unusual day for us, however, as we are being forced to vacate the Pharmalot corporate campus and schlep to the local courthouse for jury duty. So please excuse any absences. We hope to back as soon as justice is served. Meanwhile, here are some interesting tidbits. Hope your day goes well and see you soon… Pfizer Depression Drug Is Ineffective And Harmful (Reuters) Roche To Add 500 Jobs In Arizona (Arizona Daily Star) Titan Implantable Addiction Drug Beat Placebo (Bloomberg News) FDA Approves Alkermes Drug To Fight Opiate Addiction (CNN) Viagra TV Ad Schedule Is Published Online (Hollywood Reporter) Ipsen CEO Leaves Over Strategic Differences (PharmaTimes) Vaccine Liability And The Supreme Court (Pharmalot) Synosia Inks ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4065617 Wed, 13 Oct 2010 10:50:11 +0100 4065617 http://www.medworm.com/index.php?rid=3965696&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4d1Gfj-MM7I%2F Six months after the FDA determined there is no link between bisphosphonates and thigh-bone fractures, a task force says otherwise. Convened by the American Society of Bone and Mineral Research, the 26-person panel reviewed 310 cases of atypical femur fractures and found that 94 percent, or 291 patients, had taken the drugs, most for more than five years. This is the same task force report the FDA has been waiting to see before issuing recommendations (back story). The panel also found that more than a quarter of patients who experienced atypical femur fractures in one leg experienced a fracture in the other leg as well. On the other hand, the panel pointed out that atypical femur fractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965696 Tue, 14 Sep 2010 12:05:33 +0100 3965696 http://www.medworm.com/index.php?rid=3699703&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqmL_7AMPh1Q%2F This may be a bad break for drugmakers. Wellpoint is using comparative effectiveness to make it more difficult for its members to use the Boniva osteoporosis drug after its own research found greater fractures, lower compliance and higher costs than other meds, according to Dow Jones. The insurer studied 26,000 members on osteo meds, comparing Boniva, which is marketed by Roche and GlaxoSmithKline with Actonel, which is sold by Sanofi-Aventis and Warner Chilcott, and Merck’s Fosamax. Although randomized clinical trials suggest the drugs should be equivalent, WellPoint data found differences. Now, WellPoint other drugs must be tried before Boniva is approved. The drug remains where on Tier 3, or non-preferred level, on the formulary. WellPoint actually made the change last year, Dow J... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699703 Fri, 25 Jun 2010 13:57:57 +0100 3699703 http://www.medworm.com/index.php?rid=3441056&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPzAoXvU6U6Q%2F In response to generic threats on two older meds - the Ambien CR sleeping pill and Aplenzin antidepressant - and declining sales of the Actonel osteoporosis med - the big drugmaker notifed employees that 400 positions, mostly sales reps, are being eliminated. The move is the latest cutback by Sanofi-Aventis, which is grappling with the same patent cliff as rivals. To cope, Sanofi is outsourcing sales for Aplenzin, which is a not a substantial revenue generator, and restructuring its promotional arrangement with Warner-Chilcott (see this) for Actonel, which notched $264 million in sales and is a declining product (see page 85 here). The bad news - and a source says there will be more - was delivered by way of email from Jerry Durso, Jerry Durso, vp of the specialized therapeutics business u... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3441056 Tue, 06 Apr 2010 12:37:01 +0100 3441056 http://www.medworm.com/index.php?rid=3416320&cid=t_101427_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F03%2Fmany-people-believe-that-these-drugs.html John Mack asks some tough questions of bisphosphonates.Check the comments as well! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3416320 Sun, 28 Mar 2010 17:35:00 +0100 3416320 http://www.medworm.com/index.php?rid=3354580&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0pFji5IXzRE%2F Two years after issuing warnings about a group of meds known as bisphosphonates, the FDA has determined there is no link between the drugs and thigh-bone fractures (see here). These meds include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel, and Boniva, which is marketed by Glaxo and Roche. The matter, however, isn’t quite settled. The agency is continuing to work with outside experts, including the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more info. And two new studies released this week at the annual meeting of the American Academy of Orthopaedic Surgeons found bones of some post-menopausal women who take the meds on a long-term basis to prevent osteoporosis can stop rejuvenating and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3354580 Thu, 11 Mar 2010 13:42:45 +0100 3354580 http://www.medworm.com/index.php?rid=3290784&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F02%2Fdeja-vu-all-over-again-sheffield.html It's deja vu all over again.  A case reported (so far only) in the UK Times Higher Education Supplement of a biomedical researcher apparently threatened because she tried to present data that did favor a particular commercial health care product. Here is the summary:An academic has risked the wrath of her university by submitting results to a forthcoming conference without permission.The University of Sheffield has claimed that the submission has been made in breach of a contract it has with a pharmaceutical company, which funds work in the scholar's field.Guirong Jiang, a research radiologist who has worked at Sheffield for 13 years, is due to face a disciplinary hearing over her actions this week.Her findings - submitted to a symposium of the European Calcified Tissue Society (ECTS)... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3290784 Fri, 19 Feb 2010 16:59:00 +0100 3290784 http://www.medworm.com/index.php?rid=3096808&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F12%2Fbritish-medical-journal-interviews-dr.html About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was here.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical J... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3096808 Wed, 16 Dec 2009 20:54:00 +0100 3096808 http://www.medworm.com/index.php?rid=3092923&cid=t_101427_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F12%2Fdr-aubrey-blumsohn-pharmagossips-person.html Dr Aubrey Blumsohn forfeited his job after going public with concerns about access to Procter and Gamble’s research data on the osteoporosis drug risedronate. The BMJ's Clare Dyer talks to him about his experience.Read the BMJ interview. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3092923 Wed, 16 Dec 2009 09:43:00 +0100 3092923 http://www.medworm.com/index.php?rid=2832110&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F09%2Freappearance-of-ghost-of-seasons-past.html About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. The early posts were here, here, here, and here. In this post, we summarized the case thus:Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.Despite numerous req... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2832110 Fri, 25 Sep 2009 15:01:00 +0100 2832110 http://www.medworm.com/index.php?rid=2033595&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F481886458%2F The consumer products giant could sell off some or all of its pharma brands as it shifts its portfolio toward what P&G execs say are faster-growing and more profitable product categories, The Business Courier of Cincinnati reports. At an analyst briefing today, ceo AG Lafley says P&G will halt research into new drugs and, instead, manage its four key pharma brands through their respective product lifecycles, and that P&G will “consider divestiture of some or all of these brands.” These include the Actonel osteoporosis med, the Intrinsa testosterone patch for female sexual dysfunction, the Enablex drug for overactive bladders and the Asacol treatment for Crohn’s disease. Lafley says the regulatory environment for pharmaceuticals has grown more difficult and tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2033595 Thu, 11 Dec 2008 18:04:15 +0100 2033595 http://www.medworm.com/index.php?rid=1790484&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390987933%2F Next Tuesday, the struggling biotech releases data about denosumab, an experimental osteoporosis drug, and the data could make the difference between a multi-billion-dollar med and an also-ran in a crowded field. No small moment for a company that has staggered from setback to setback with its existing meds. “Denosumab is a mega-blockbuster opportunity and will now emerge as the principal long-term value driver,” Morgan Stanley analyst Steven Harr wrote in a recent research note, Reuters reports. “We see a high probability of regulatory success given data to date.” Two months ago, Amgen reported denosumab significantly reduced the risk of spine fracture in a three-year trial of 7,800 post-menopausal women, but never disclosed exactly how much the risk was reduced. T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790484 Fri, 12 Sep 2008 21:02:46 +0100 1790484 http://www.medworm.com/index.php?rid=1581892&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F07%2Fmore-watchdogs-who-did-not-bark-ucu.html We posted first here in 2005, then here, here, here, here, here, here, here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Some of the analyses done by P&G seemed biased in favor of the drug. Despite repeated attempts, P&G would not give Blumsohn access to the raw data of the project. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" fo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1581892 Sat, 05 Jul 2008 20:23:00 +0100 1581892 http://www.medworm.com/index.php?rid=1134007&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F212705996%2F The agency is urging doctors to be on the lookout for the “possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain” in patients taking a group of meds known as bisphosphonates. These include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel and Boniva, which is marketed by Glaxo and Roche. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics, the FDA cautions on its web site. The severe musculoskeletal pain may occur within da... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1134007 Mon, 07 Jan 2008 17:55:44 +0100 1134007 http://www.medworm.com/index.php?rid=947289&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F10%2Fblogscan-journal-changes-policy-after.html On the PharmaLot blog, Ed Silverman posted about the latest developments in the case of Dr Aubrey Blumsohn, who lost his job after he tried to get the data from the study he lead of Actonel from the study's commercial sponsor, Procter & Gamble (see Dr Blumsohn's blog here.) The journal that published an allegedly ghost-written story whose data Blumsohn charged was analyzed in a questionable manner just announced a change in its policy seemingly meant to prevent such problems in the future. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=947289 Fri, 12 Oct 2007 20:46:00 +0100 947289 http://www.medworm.com/index.php?rid=947466&cid=t_101427_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F169012657%2F Over the past three years, a controversy raged concerning a study about Procter & Gamble’s Actonel osteoporosis med in the Journal of Bone and Mineral Research. Although the tale was complicated and sordid, at its heart was the issue of corporate influence over study data and the responsibilities of a journal to act as a credible gatekeeper of information. For these reasons, the astonishing spat between the journal, P&G and a UK researcher, Aubrey Blumsohn, gained considerable media attention. Now, though, the journal promises to behave, well, differently. What caused this ruckus? To keep it simple, an Actonel study was conducted by Blumsohn and Richard Eastell, a Sheffield University colleague, and the results were favorable. However, they had divided the work. Blumsohn su... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=947466 Fri, 12 Oct 2007 16:46:20 +0100 947466 http://www.medworm.com/index.php?rid=938781&cid=t_101427_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167504668%2Fteva_pharmaceutical_industries.html Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that it has received final FDA approval for its Abbreviated New Drug Application for the generic version of Actonel.Actonel, a Procter & Gamble Company (NYSE:PG) product, is used in the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.Teva is currently in patent litigation concerning the generic version of Actonel. A trial was held in November 2006 but no decision has been rendered. As part of the litigation Teva agreed to give a 30 day notice to Procter and Gamble prior to any launch of the product. Notice has not yet been given.Teva has been awarded 180 days marketing exclusivity for being the first company to file an Abbreviated New Dr... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=938781 Tue, 09 Oct 2007 17:00:03 +0100 938781 http://www.medworm.com/index.php?rid=674877&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fblogscan-link-between-actonel-and.html On the Scientific Misconduct Blog, Aubrey Blumsohn shows a surprising link between the case with which he was personally involved (which included allegations of suppression of medical research on the drug risedronate [Actonel], made by Procter & Gamble, and intimidation of a whistle-blower, Dr Blumsohn himself, see our most recent post on it here), and the evolving case of Avandia (which includes apparent past suppression of research on the drug, also known as rosiglitazone, made by GlaxoSmithKline, and intimidation of multiple whistle-blowers, see our most recent post here). (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=674877 Mon, 11 Jun 2007 15:41:00 +0100 674877 http://www.medworm.com/index.php?rid=650722&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Freporters-close-encounter-with-big.html I stumbled across an interesting article in a relatively obscure media source (the Berkshire Eagle, located in the beautiful Bershire mountains of Massachusetts, USA). The reporter, Barbara Quart, experienced something of a personal odyssey after attending a medical research convention,LATE LAST month I attended the 7th International Osteoporosis Symposium in Washington, D.C. I thought I'd learn a lot that I could then pass on to other older women in the Berkshires, many as little conscious of osteoporosis as I had been, and I hoped to get clearer what to do about my own diagnosis, and the urgently prescribed medication for it, which I have refused for a year now.The event was basically a five-day non-stop education — some might call it a fancy sales job, or even indoctrination — by MD... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=650722 Fri, 01 Jun 2007 18:21:00 +0100 650722 http://www.medworm.com/index.php?rid=477986&cid=t_101427_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F03%2Factonel-procter-and-gamble-and-things.html We had posted a while back and again here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.This story, like those of other cases of research sup... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=477986 Fri, 16 Mar 2007 18:23:00 +0100 477986