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 'accutane'. Sat, 03 Sep 2011 02:30:58 +0100 http://www.medworm.com/index.php?rid=4984451&cid=t_136903_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdoes-accutane-cause-inflammatory-bowel-disease-the-evidence-is-weak%2F2011.06.29 At home the kids’ current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye. Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded. My eye may have been caught because of ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4984451 Wed, 29 Jun 2011 17:00:47 +0100 4984451 http://www.medworm.com/index.php?rid=4704959&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOvRuuYAAJLA%2F And the revolving door keeps revolving. Former Congressman Bart Stupak, who gained a high profile and occasional notoriety for his watchdog approach toward the pharmaceutical industry and the FDA, has just signed on as a legislative and government affairs partner with Venable, a law firm that has a sizeable practice helping drug and device makers. “I’ve had numerous contacts with Venable partners over the years and am excited about helping my new colleagues and the firm’s clients navigate choppy congressional waters,” says Stupak, a former police officer, Michigan state trooper and nine-term congressman, in a statement e-mailed to us. This will be a decidedly different role for Stupak. As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704959 Mon, 11 Apr 2011 16:41:59 +0100 4704959 http://www.medworm.com/index.php?rid=4696952&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZQ07CF6t0yY%2F For actor James Marshall, his latest appearance offered an unhappy ending. A New Jersey state court jury late last week denied his claim that he developed inflammatory bowel disease after using the Accutane acne med once sold by Roche. His colon was subsequently removed and he sued the drugmaker for $30 million, charging the pill derailed a once-promising acting career. To bolster his case, Marshall relied on testimony from director Rob Reiner and actor Martin Sheen (yes, his son is Charlie Sheen), a move that generated an unusual degree of attention for a product-liability lawsuit involving a prescription med. His Hollywood pals volunteered that Marshall, 42, was headed for stardom before his ailments upended his career. But the jury decided Marshall had a pre-existing intestinal conditio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4696952 Mon, 11 Apr 2011 12:49:08 +0100 4696952 http://www.medworm.com/index.php?rid=4636662&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlYLOC-LmD10%2F And so another working week soon draws to a close. This is, of course, the signal to dream about weekend plans. Our agenda calls for spending time with the short people and cleaning up around the Pharmalot corporate campus. And you? Will you catch up on some sleep? Read an e-book? Take a walk in the park? Have a good time, whatever you do. And be safe. Meanwhile, here are some tidbits. Catch you soon, everyone… Medical Marijuana Sales Rival Viagra (Time) Cephalon Wins Ruling Over Generic Copy Of Watson’s Fentora (Reuters) Martin Sheen Testifies In Accutane Trial (ABA Journal) Branded Discounts Save Seniors $38M In Two Months (Pharma Times) Prevanar Vaccine To Resume In Japan (Bloomberg News) Pfizer Drugs Shrinks Pancreatic Tumors In Research (Bloomberg News) FDA OKs Merck Shing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636662 Fri, 25 Mar 2011 12:10:36 +0100 4636662 http://www.medworm.com/index.php?rid=4464701&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbUj0HjKisYk%2F The usual interplay between Hollywood and drugmakers occurs when a celebrity endorses a drug. Now, though, Roche is about to encounter a Hollywood experience of an entirely different sort - James Marshall, who played a US Marine in the 1992 hit film ‘A Few Good Men,’ claims his acting career was derailed after he used the Accutane acne pill and developed inflammatory bowel disease. His colon was subsequently removed and he is suing the drugmaker for $30 million $11 million in lost earnings. His trial, and two others, start next week in a New Jersey courtroom and the spectacle is likely to cause a side effect of its own - attention on product liability litigation in ways that previous lawsuits have not generated. For all of the thousands of such lawsuits filed against drugmakers in rec... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464701 Fri, 11 Feb 2011 15:38:19 +0100 4464701 http://www.medworm.com/index.php?rid=4314221&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6v6OHNUJQ_Y%2F Greetings, everyone. How are you this morning? We trust you feel invigorated as another day gets under way. As usual, we are brewing a delicious cup of stimulation and poking around for interesting items. Heard something fascinating? Send us a note. Meanwhile, we hope your workload is manageable and much gets accomplished. Catch you soon… Pfizer Faces 1,200 Chantix Lawsuits (Birmingham News) Spectrum To Make Biosimilar Of Roche’s Rituximab (Reuters) Roche Wins Wider Approval For Actemra (Bloomberg News) Evidence Links Avastin To Heart Failure In Breast Cancer Patients (HealthDay) EMA Worries Over Foreign APIs (InPharma-Technologist) J&J Files For FDA Approval Of Bloodthinner (Associated Press) Celgene Submits New Applications For Cancer Meds (Reuters) Xoma Inks $505M Diabe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4314221 Wed, 05 Jan 2011 12:48:44 +0100 4314221 http://www.medworm.com/index.php?rid=4159500&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F59g-zKJrLv0%2F Whether the Accutane acne med is capable of causing someone to attempt suicide has been a long-standing debate. Severe acne, after all, is known to be very disturbing, suggesting some Accutane patients may already be disposed to consider suicide. Yet a sure-fire scientific link has been lacking. Now, a new study in BMJ, while not offer such a link, nonetheless, suggests the possibility exists. The study examined 5,756 patients between 15 and 49 years old who were prescribed Accutane for severe acne between 1980 and 1990. Ultimately, 128 patients were admitted to a hospital for attempted suicide on 210 occasions and 24 patients committed suicide. After parsing the data and weighing the confounding scenarios, the researchers concluded an increased risk of attempted suicide with Roche’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4159500 Fri, 12 Nov 2010 15:41:37 +0100 4159500 http://www.medworm.com/index.php?rid=4003436&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FebX3i3LnNno%2F Suicide has become a big issue in drug development in recent years. Consider the controversy over links to various antidepressants, notably in youngsters, and then the spate of reports involving meds for epilepsy, obesity, acne and smoking cessation (see here, here, here and here). The FDA, however, is concerned the signals largely stemmed from retrospective meta-analyses and spontaneous adverse event reports. And so the agency is considering a more deliberate approach toward clinical study and has issued a guidance with this explanation: “Given the wide range of drugs involved, it is reasonable to consider whether prospective assessments for suicidality should be included in clinical trials involving at least selected drugs for non-psychiatric indications.” “There are tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003436 Mon, 27 Sep 2010 13:02:45 +0100 4003436 http://www.medworm.com/index.php?rid=3976713&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJsk5uZLlKbk%2F Good morning, everyone. Another shiny day here on the Pharmalot corporate campus, where the short people are scampering and the dogs are barking. As always, there is much to do, especially as yet another diet pill will be reviewed today by an FDA panel. And so let the races begin. Have a great day and catch you later… Insurers Try Incentives To Improve Med Adherence (Health Leaders) Sanofi CEO Says Chance Of Genzyme Deal Is Reasonable (Bloomberg News) Acne Depression Link May Not Be Due To Drugs (Reuters) Avandia Is A PR Mess, Not A Financial Mess (Fortune) FDA Staff Backs High-Dose Of Boehringer Clot Drug (Reuters) Montana Governor Says Drugmakers Avoid Taxes (Bloomberg News) Genzyme Sees End To Fabrazyme Rationing (The Wall Street Journal) UK’s NICE Says No To Glaxo Leukemia ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976713 Thu, 16 Sep 2010 12:16:31 +0100 3976713 http://www.medworm.com/index.php?rid=3858378&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRwAUFTIH1Qg%2F In response to harsh criticism that important side effect information was being kept hidden from the public, the European Medicines Agency has agreed to make adverse events available, and the move is likely to result in additional complaints filed by consumers. The change in policy comes after EMA ombdusman Nikiforos Diamandouros chastised the agency twice in recent months for refusing to release documents containing suspected adverse reactions caused by the Accutane acne med and then two diet pills, Acomplis, which was withdrawn by Sanofi-Aventis, and orlistat, which is sold as Xenical by Roche and as Alli, an over-the-counter med marketed by GlaxoSmithKline (back story here and here). “EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he sai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3858378 Wed, 11 Aug 2010 19:26:24 +0100 3858378 http://www.medworm.com/index.php?rid=3831559&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0LpYE6xQNAk%2F Just as Roche faced the unsettling prospect of going to court against a Hollywood star over side effects linked to its Accutane acne pill, the drugmaker has won an important victory. A New Jersey appeals court reversed a $10.6 million verdict, because a lower-court judge improperly barred evidence about the use of the controversial medication. The upshot is that Roche’s lawyers should have been able to present data during a 2008 trial about how many acne sufferers used Accutane, which was blamed for causing a Utah woman to develop inflammatory bowel disease. Moreover, the decision prompted a delay in the trial this week of actor James Marshall, who made the same allegations (see here). This was first reported by Bloomberg News. “Roche was unduly impeded at this trial from adducing and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3831559 Fri, 06 Aug 2010 12:33:27 +0100 3831559 http://www.medworm.com/index.php?rid=3816755&cid=t_136903_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F08%2Flolpharma-contd-next-witness-is.html Jim has the story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3816755 Tue, 03 Aug 2010 11:56:00 +0100 3816755 http://www.medworm.com/index.php?rid=3813205&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZWj--7jBgN8%2F The usual interaction between Hollywood and the pharmaceutical industry takes place when a celebrity endorses a drug. Roche, for instance, has successfully employed Sally Fields to promote its Boniva med for osteoporosis. Now, though, Roche is about to encounter a Hollywood experience of an entirely different sort - James Marshall, who played a US Marine in the 1992 hit film ‘A Few Good Men,’ claims his acting career was derailed after he used the Accutane acne pill and developed inflammatory bowel disease. His colon was subsequently removed and he is suing the drugmaker for $11 million. His trial starts this week in a New Jersey courtroom and the spectacle is likely to cause a side effect of its own - attention on product liability litigation in ways that previous lawsuits ha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3813205 Mon, 02 Aug 2010 13:52:06 +0100 3813205 http://www.medworm.com/index.php?rid=3761625&cid=t_136903_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F07%2Fdoug-bremner-speaks.html Doug Bremner MD interviewed by Neil Shulman MD about problems with the pharmaceutical industry.Part 1 of 5http://www.facebook.com/pages/Doug-Bremner-MD-Talks-About-Problems-with-the-Pharmaceutical-Industry/119299444783293http://www.youtube.com/user/jamesdouglasbremner (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3761625 Sat, 17 Jul 2010 01:22:00 +0100 3761625 http://www.medworm.com/index.php?rid=3714183&cid=t_136903_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fsummertime-acne-facts%2F2010.06.30 With blonde hair and big blue eyes, she looked like a young Betty Draper from Mad Men. My patient, Julie, had been faithfully treating her acne for months. Just when it was starting to clear up (in time for her senior photos) — wham! – red dots cropped up over her forehead and cheeks. What went wrong? Summertime. July can be the cruelest month for acne. Acne on the chest and back (bacne) and big, red pimples on your face can make going to the beach an embarrassing experience. (more…) *This blog post was originally published at The Dermatology Blog* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3714183 Wed, 30 Jun 2010 22:00:12 +0100 3714183 http://www.medworm.com/index.php?rid=3552545&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI42DKu7h6mE%2F The European Medicines Agency (EMEA) recently refused to release documents containing suspected adverse reactions caused by Accutane (which is called Roaccutane in the UK), after a law firm in two years ago Ireland requested info that dated back to 1992. At issue were reports linking the acne drug to suicidal tendencies, a topic that has been the subject of controversy and litigation for years (see here). And so European Ombudsman Nikiforos Diamandouros yesterday vigorously disagreed with the EMEA argument that transparency rules do not apply to these reports. “EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he said in a statement. “Since its work has a direct impact on the health of European citizens, it is of utmost importanc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3552545 Tue, 11 May 2010 12:42:17 +0100 3552545 http://www.medworm.com/index.php?rid=3552548&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMS-PTE-LQVU%2F Hello, everyone. Nice to see you again. Another shiny day here on the Pharmalot corporate campus where the grounds are being spruced up in a long overdue move. What will today bring? Important meetings and deadlines, no doubt. As you ready yourself, here are a few items to help you along. Best of luck and catch you later… Galapagos Widens Lung Drug Deal With Roche (Reuters) Drugmakers Leave New Jersey’s Medicine Chest Bare (NJ Spotlight) Purdue Files Patent Infringement Suit Against Ranbaxy (Business Standard) Merck And Glenmark Settle Zetia Patent Suit (Bloomberg News) UK Drug Shortages May Last Until 2011 (PharmaTimes) Proton Pump Inhibitors Increase Bone Fracture Risk (Los Angeles Times) Cost Of Treating Cancer Doubles (Associated Press) Roche Seeks Deal Approval In Accutane... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3552548 Tue, 11 May 2010 11:31:23 +0100 3552548 http://www.medworm.com/index.php?rid=3460395&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr4doEN28UV4%2F The answer is unclear, although no doubt many pharma execs and FDA officials won’t miss Bart Stupak, a Michigan Democrat who is retiring from Congress after a nasty brawl over health care reform and, in particular, abortion coverage (background here). As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee, Stupak regularly took on safety issues. Along with John Dingell, who formerly headed the House committee, Stupak investigted Merck and Schering-Plough for allegedly delaying the release of unfavorable clinical trial data for their Vytorin cholesterol med (see here and here). He also subpoenaed FDA investigators for approving the Ketek antibiotic, despite knowing a key safety study was fraught with problems; Sanofi-Aventis execs wer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3460395 Mon, 12 Apr 2010 12:21:04 +0100 3460395 http://www.medworm.com/index.php?rid=3280192&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGC58szRMfaQ%2F Andrew McCarrell, 38, won a jury verdict at a retrial in Atlantic City, N.J. An appeals court ordered a new trial, having overturned a $2.6 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Al., testified he developed inflammatory bowel disease after taking Accutane for acne in 1995. He needed five surgeries, including one to remove his colon. The verdict was the largest of six for Accutane users who won awards totaling $56 million, Bloomberg News notes. Roche lost every case, although a Florida appeals court overturned one judgment for $7.2 million. In each case, plaintiffs claimed Roche failed to warn adequately of the risks (background on links to IBD). Roche, which intends to appeal the verdict, stopped selling Accutane in June 2009, citing generic com... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3280192 Wed, 17 Feb 2010 12:56:06 +0100 3280192 http://www.medworm.com/index.php?rid=3251394&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCdxsYxJTsbs%2F A New Jersey appeals court decided last week that a trial court should reconsider whether an expert should be allowed to testify in a lawsuit alleging the Accutane acne drug causes depression. And the move, which comes as part of long-standing litigation over the issue, may cause some controversy. The New Jersey trial court, where hundreds of lawsuits allege Accutane is tied to depression, had ruled that Emory University professor Doug Bremner should not be allowed to offer expert testimony due to what was considered a flawed study. His study was funded by Accutane plaintiffs and lawyers, and published in a peer-reviewed article in the American Journal of Psychiatry in 2005. Accutane, by the way, was withdrawn last year, although generics are still available. Using positron emission tomogr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3251394 Mon, 08 Feb 2010 14:45:05 +0100 3251394 http://www.medworm.com/index.php?rid=2974211&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvyuWRPpjgkY%2F Those who use the popular acne drug, which Roche stopped selling last June but remains available as a generic, have almost twice the odds of developing IBD as those not taking the pill, according to a new study, The Los Angeles Times reports. At the annual meeting of the American College of Gastroenterology in San Diego last week, the paper writes, researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of IBD, which is characterized by intestines that become chronically red and swollen, producing pain, cramping, diarrhea, weight loss and bleeding They compared 8,189 cases of IBD with 21,832 healthy individuals and found the odds of developing such diseases were 1.68 times higher those who took the acne drug. Those who filled four or more pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2974211 Mon, 09 Nov 2009 13:34:03 +0100 2974211 http://www.medworm.com/index.php?rid=2934948&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0KaJ01YfSO8%2F A three-judge panel has reversed a $7 million judgment against Hoffman-La Roche, which sold Accutane. A federal court ruled yesterday in favor of the drug maker and against a Pensacola, Fl., man who had most of his colon removed due to inflammatory bowel disease linked to the acne drug, the Associated Press reports. The unanimous opinion said the patient, Adam Mason, failed to prove an allegedly deficient warning label was the proximate cause of his ailment. Mason had argued warning that Accutane was “temporally associated” with inflammatory bowel disease was too weak. But his dermatologist testified he would have prescribed the drug even if the warning had been stronger. Last June, Roche withdrew Accutane, citing generic competition and the cost of product liability litigation... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2934948 Wed, 28 Oct 2009 12:07:32 +0100 2934948 http://www.medworm.com/index.php?rid=2584229&cid=t_136903_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FmW9zVlURRnQ%2F The pharmaceutical company Hoffmann-La Roche, Inc, has issued a statement stating that they will no longer produce the acne medication, Accutane, which they had developed and brought to the U.S. market in 1982. Accutane, otherwise known by its generic name, isotretinoin, will still be available by other drug makers, but not by HL and not under the name of Accutane. The press release issued by the pharmaceutical states that this is a business decision, due to declining profit from the drug. When Accutane became available, it was widely used for recalcitrant acne , or acne that didn’t respond to any other treatments. The problem with Accutane, however, is that its potency makes it dangerous for certain people to take it, such as pregnant women. Doctors have also been finding an increa... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2584229 Wed, 08 Jul 2009 22:56:09 +0100 2584229 http://www.medworm.com/index.php?rid=2033600&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F481581760%2F Whether a medication guide provided by Roche for its Accutane acne drug adequately warned of inflammatory bowel disease will have to be decided by a jury in litigation brought against the drugmaker by 84 people in a New Jersey state court, Mealey’s Emerging Drugs & Devices reports. The plaintiffs allege Accutane caused them to develop IBD and Roche sought a summary judgement to dismiss the litigation, arguing that a patient medication guide adopted in January 2001 made warnings about IBD adequate, according to Mealey’s. But Superior Court Judge Carol Higbee agreed with the plaintiffs that the language of the med guide does not mention IBD. “In fact, the new language refers generally to ‘the liver, pancreas, and bowel,’ ” she wrote. “It is so general it co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2033600 Thu, 11 Dec 2008 11:45:24 +0100 2033600 http://www.medworm.com/index.php?rid=1720556&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F369954815%2F A federal appeals court will soon decide whether to allow testimony from an expert witness who sought to show that the Accutane acne med causes a chronic bowel disorder, the Associated Press writes. Yesterday, attorneys urged a three-judge panel to admit the testimony from the expert, which is central to their argument that the prescription drug causes inflammatory bowel disease. For its part, Roche contends Accutane is not connected to the disease and that the expert made “leaps of faith” in trying to track a connection between the two. The case is the latest in a wave of lawsuits that accuse Roche of downplaying a link between Accutane and inflammatory bowel disease. Plaintiffs lawyers have already won a trio of multi-million dollar jury awards, and they say they have hundred... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1720556 Wed, 20 Aug 2008 13:02:50 +0100 1720556 http://www.medworm.com/index.php?rid=1714163&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F368965093%2F Nice to see you again. As we ease back into our routine after a long-needed and enjoyable vacation, we are struck by the ongoing pace of events. For those who missed it yesterday evening, please scroll down to read the latest report in the Annals of Internal Medicine about a Vioxx ’seeding’ study. Meanwhile, we are readying ourselves for another day. Hope yours goes well… Appeals Court To Hear Accutane Lawsuit (Associated Press) Novo: No Rise In Pancreatitis From Experimental Drug (Reuters) Medco And FDA To Study Genetics In Prescribing (The Wall Street Journal) Dishman To Supply Bulk Drugs To Merck & AstraZeneca (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1714163 Tue, 19 Aug 2008 11:41:19 +0100 1714163 http://www.medworm.com/index.php?rid=1409901&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281054181%2F Several years ago, Emory University psychiatry and radiology professor Doug Bremner was immersed in a long-running controversy over Accutane and links to suicide. His research vexed the drugmaker, Roche, and he wound up as an expert witness in litigation. The experience and subsequent scandals about undisclosed side effects prompted him to write a book, “Before You Take That Pill: Why The Drug Industry May Be Bad For Your Health.” In his view, consumers need more info than they generally receive and so Bremner, who has also consulted for Glaxo, Novartis and Wyeth, details the risks, benefits and other background data on some 300 meds. This is an excerpt from a recent conversation… Pharmalot: What made you write this book? Bremner: It came out of my work with Accutane, aft... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1409901 Wed, 30 Apr 2008 21:24:21 +0100 1409901 http://www.medworm.com/index.php?rid=1392577&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275682655%2F A New Jersey state court jury today awarded $10.6 million in compensation to a Utah woman who claims to have developed inflammatory bowel disease from taking Roche’s Accutane acne drug, according to Mealey’s. The nine-member jury in the Atlantic County Superior Court ruled that the pill cause IBD, and Hoffman-La Roche failed to adequately warn the plaintiff, Kamie Kendall and her doctor, about Accutane’s IBD risks before April 1999. As a result, the failure to warn was the proximate cause of Kendall’s IBD. The jury voted 9-0 on those three questions, and voted 7-2 to award compensation of $78,500 for past medical expenses and $10.5 million in unspecified compensation. A source told Mealey that Judge Carol Higbee denied a motion to award punitive damages. Kendall’s case w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1392577 Tue, 22 Apr 2008 21:14:24 +0100 1392577 http://www.medworm.com/index.php?rid=1073282&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F196031991%2F That we are. And all the better to learn about interesting developments. And of course, there are several. While we work on bringing you an interesting exclusive later today, please enjoy these… Experimental Fat Drugs Shows Promise For HIV Patients (Forbes/HealthDayNews) FDA Eases Access To Accutane (Yahoo/AP) AstraZeneca Upbeat About Seroquel XR Data For Depression (PharmaTimes) Pfizer And Adolor Ink R&D Deal (TheStreet.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1073282 Thu, 06 Dec 2007 11:14:47 +0100 1073282 http://www.medworm.com/index.php?rid=1067908&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194418353%2F Procedural rulings emanating from lawsuits are, generally, so much inside baseball. But they matter; sometimes, a great deal. And so earlier this year, a little-noticed ruling allowed Novartis to do something drugmakers and their lawyers pine to do - transfer lawsuits filed in state courts to federal courts, Drug & Device Law blog reports. The details, admittedly, are a bit arcane for those who aren’t members of the bar, but here’s why this has practical importance: Generally, a drugmaker prefers to have a case heard in federal court for a few reasons - federal judges have more clerks to help allot their time; juries in federal courts must be unanimous, but not always in state courts; judges are appointed for life in federal court but are elected in some state courts; and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1067908 Mon, 03 Dec 2007 15:28:21 +0100 1067908 http://www.medworm.com/index.php?rid=1024400&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184151041%2F The popular acne med may disrupt serotonin production in the brain, leading patients to feel depressed and prompting a risk of suicide, according to Sarah Bailey in the University of Bath’s department of pharmacy and pharmacology, The Scotsman reports. “Serotonin is an important chemical that relays signals from nerve cells to other cells in the body,” she tells the paper. “In the brain, it is thought to play an important role in the regulation of a range of behaviours, such as aggression, anger and sleep. Low levels of serotonin have been linked to depression, as well as bipolar and anxiety disorders. Many medications aimed at treating depression seek to increase levels of serotonin to help overcome these problems. Our findings suggest that (Accutane) might disrupt... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1024400 Tue, 13 Nov 2007 15:11:07 +0100 1024400 http://www.medworm.com/index.php?rid=944706&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F168646771%2F The drugmaker was handed its second defeat in as many trials over charges the acne med caused inflammatory bowel disease. The latest case occurred in Florida, where a jury decided Roche failed to adequately warn of Accutane’s risks and helped cause Crohn’s disease in an unemployed, 31-year-old welder, who took the drug for nine years. “It will help me with medical expenses and everything,” Adam Mason, who suffers from diarrhea, fatigue, and depression, tells Bloomberg News. “I’m glad it’s all over with. It’s been a long ride. Seven years.” Roche faces 400 lawsuits blaming Accutane for causing inflammatory bowel disease. A New Jersey jury in May awarded $2.62 million to an Alabama man in the first such case to reach trial, the wire serv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=944706 Thu, 11 Oct 2007 22:08:48 +0100 944706 http://www.medworm.com/index.php?rid=938930&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F167575459%2F Finished that long meeting? Hungering for a cup of coffee? Eager to stare out the window and forget it all? We’ll help you keep focused… J&J Sues Hologic Over Patents For Tumor-Detection Products (Bloomberg News) Parexel Purchases A Clinical-Research Organization In Taiwan (Outsourcing-Pharma) Wall Street Expects Biotechs To Post A Mixed Third Quarter (Yahoo/AP) Roche And FDA Loosen Some Restrictions On Accutane Prescriptions (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=938930 Tue, 09 Oct 2007 19:34:50 +0100 938930 http://www.medworm.com/index.php?rid=864409&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155093256%2F The folks at Mental Floss, the provocative web site that prompts you to laugh and tax your brain all at once, are daring us to match drugs with side effects. Perhaps they think everyone is paying attention to those fast-as-lightning disclaimers announced at the tail end of TV ads. In any event, here is the list of drugs, followed by the list of side effects. Take a look, then go to the Mental Floss Pop Quiz (right here), type in your answers and see how much you really know… 1 - Alli 2 - Levitra 3 - Accutane 4 - Rogaine 5 - Ambien 6 - Botox 7 - Lipitor 8 - Topamax 9 - Frontline Plus 10 - Paxil “Babies born to mothers who have taken [this drug] in the latter half of pregnancy have reported complications, including difficulties with breathing, turning blue, floppiness, stiffness,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=864409 Tue, 11 Sep 2007 16:07:44 +0100 864409 http://www.medworm.com/index.php?rid=811321&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F146148252%2F The acne med is being blamed for the brutal October 2006 murder of a Chicago dermatologist, David Cornbleet (pictured to the left). He prescribed the med to Hans Peterson, 29, who took Accutane just once or twice and later returned to the doctor’s office, allegedly killing him, according to media reports from Chicago. An e-mail released by the Peterson family blames Accutane, Roche, the FDA and the doctor for allowing Accutane on the market despite links to suicidal thoughts after Peterson last week turned himself in to French authorities on the island of St. Martin and allegedly confessed to killing Cornbleet. Authorities are trying to extradite him to face murder charges in Illinois, which will be a tricky diplomatic issue because the French are unlikely to extradite Peterson if ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=811321 Mon, 20 Aug 2007 15:13:31 +0100 811321 http://www.medworm.com/index.php?rid=797223&cid=t_136903_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F143772541%2F The allegation that Accutane is somehow linked to suicidal thoughts and behavior has largely been a sideshow compared with the birth defect risks associated with the popular acne med, but it has lingered for nearly a decade. And this morning, US District Court Judge James Moody, who is overseeing multi-district litigation filed in Florida, ruled that Emory University Douglas Bremner psychiatry professor can testify as an expert witness for the plaintiffs. Why does this matter? “This is significant because it’s the first time that he’ll be appearing at trial and introducing evidence - brain scans he conducted - that indicate the drug is linked to suicide,” says Mike Ryan, an attorney who has filed most of the two dozen or more Accutane suicide lawsuits around the cou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=797223 Mon, 13 Aug 2007 20:16:16 +0100 797223 http://www.medworm.com/index.php?rid=777574&cid=t_136903_112_f&fid=34614&url=http%3A%2F%2Fthewelltimedperiod.blogspot.com%2F2007%2F08%2Fevaluating-program-designed-to-prevent.html Last year the FDA decreed that reproductive age women, in consultation with their physicians, are incapable of using Accutane, an acne drug, properly.In order to protect women from themselves the FDA decided to only allow these women to receive proper care if they sign their life away 1) register their personal medical information with the government, and 2) submit to pregnancy tests. [Accutane is contraindicated in pregnancy.]So the FDA paid a lot of money to a private company to enroll patients in a program (iPledge) designed to prevent pregnancies from happening in those patients.It's now over a year later, and the results are in. Let's see how well 100 million dollars of your tax money protect women from themselves:• 122 pregnancies reported in the program's first year.[That's about ... The Well-Timed Period blogs http://www.medworm.com/rss/comments.php?id=777574 Thu, 02 Aug 2007 04:53:00 +0100 777574