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 'fda:'. Wed, 21 Jul 2010 10:55:10 +0100 http://www.medworm.com/index.php?rid=3772215&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FtFV5atXpp7o%2F J&J didn't venture a guess on how much the recalls could hurt its sales or earnings in 2011, or whether there would be residual damage. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3772215 Tue, 20 Jul 2010 19:10:37 +0100 3772215 http://www.medworm.com/index.php?rid=3772467&cid=t_355754_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=3772218&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FrZoVSPhjKKU%2F Also: hospitals using Tasers; cautious optimism over a possible HIV preventive; end of the line for swine flu pandemic? (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3772218 Tue, 20 Jul 2010 12:16:27 +0100 3772218 http://www.medworm.com/index.php?rid=3772346&cid=t_355754_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2FVwcrrV9DMMU%2F We mentioned in our recent market report that NovaVision had declared bankrupcy. The company tried to transform its business model in the last couple of years — obviously it didn’t work. Now the trustee is sharing a few more details and looking for ways to dispose of its assets: NovaVision’s FDA-Cleared Visual Restoration Therapy (VRT) System and Company Assets Now Available (press release) The bankruptcy trustee has engaged The Magnum Group, Inc., to solicit offers for NovaVision’s assets which include the NovaVision Visual Restoration Therapy (VRT) system, a neuroplacticity (sic) platform that has been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of stroke, traumatic brain injury, amblyopia (“lazy eye”) and optic nerve damage. NovaVision has recei... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=3772346 Tue, 20 Jul 2010 09:28:08 +0100 3772346 http://www.medworm.com/index.php?rid=3767074&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fgovernment-decisions-about-avandia-and-preventive-services%2F2010.07.19 An FDA advisory panel has voted that the diabetes drug Avandia (rosiglitazone) can remain on the market, but recommended further warnings associated with its use. The panel was divided, the New York Times reported, with 12 of 33 members saying the drug should be removed from the market, 10 voting to restrict sales and strengthen the warning label, 7 recommending only strengthening the warning label, and 3 voting for no change. One panel member abstained. (New York Times) The White House yesterday announced which preventive services would be available at no charge to patients under the new healthcare legislation. Adult patients who choose a health plan after September 23 will receive mammograms, diabetes screening, and tobacco cessation counseling, among other services, at no increased cos... Better Health blogs http://www.medworm.com/rss/comments.php?id=3767074 Mon, 19 Jul 2010 23:45:57 +0100 3767074 http://www.medworm.com/index.php?rid=3767034&cid=t_355754_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fprosecuting-doctors-for-importing-iuds.html Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared in the Providence Journal, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved.The Unapproved IUDsHere are the main points. The issue that caused so much local controversy was the use of unapproved IUDs:Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3767034 Mon, 19 Jul 2010 16:10:00 +0100 3767034 http://www.medworm.com/index.php?rid=3767055&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FYYgLF92nD1g%2F What will the FDA's oncology-drug panel recommend for Roche's Avastin? (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3767055 Mon, 19 Jul 2010 13:19:25 +0100 3767055 http://www.medworm.com/index.php?rid=3767056&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FCN19pjQgW4E%2F Also: new temporary insurance pools see abortion coverage restricted; FDA looks at diagnostics. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3767056 Mon, 19 Jul 2010 12:43:16 +0100 3767056 http://www.medworm.com/index.php?rid=3761410&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FV25cfNI9FW8%2F Is the bar set too high for weight loss drugs? (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3761410 Fri, 16 Jul 2010 20:42:41 +0100 3761410 http://www.medworm.com/index.php?rid=3761631&cid=t_355754_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FIb2gy5zIn1o%2Fnew-pharma-jobs-and-fda.html Pixels and Pills has been looking at new job opportunities in Pharma this week. Today's post focuses on potential jobs that could be developed in the FDA. Russ Ward suggests the idea of social media strategists in the FDA. Could this position stretch across lines and be found at the state and local level as well? What are some of the benefits we could see coming from state and local media strategists in the FDA? Read the full article here. (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3761631 Fri, 16 Jul 2010 16:05:00 +0100 3761631 http://www.medworm.com/index.php?rid=3761412&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FcZ3lP7rKS-c%2F Whether or not to stay on Avandia will come down to a judgment call. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3761412 Fri, 16 Jul 2010 13:52:01 +0100 3761412 http://www.medworm.com/index.php?rid=3757840&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FkBzTjsEJkzM%2F Two other anti-obesity drugs are up for FDA approval. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3757840 Thu, 15 Jul 2010 21:58:32 +0100 3757840 http://www.medworm.com/index.php?rid=3757842&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FPy6BUYDBvR0%2F The FDA advisory panel's crucial vote leaves a lot of room for interpretation, as news headlines show. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3757842 Thu, 15 Jul 2010 14:30:34 +0100 3757842 http://www.medworm.com/index.php?rid=3757843&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F8njEycvFmDM%2F Also: meaningful use likely to benefit GE and others; early Alzheimer's diagnosis less costly; lobbying over preventive services; weight loss drugs. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3757843 Thu, 15 Jul 2010 12:31:58 +0100 3757843 http://www.medworm.com/index.php?rid=3753788&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fgd0CcaRUdPw%2F On the final vote, most panelists recommended Avandia stay on the market but have more label warnings or a restricted use. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3753788 Wed, 14 Jul 2010 20:16:14 +0100 3753788 http://www.medworm.com/index.php?rid=3753791&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FfwetVFFMCqQ%2F Also: a new head for PhRMA; Maine wants out, temporarily, of one health-overhaul requirement; a union's suit against Pfizer. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3753791 Wed, 14 Jul 2010 13:08:24 +0100 3753791 http://www.medworm.com/index.php?rid=3749856&cid=t_355754_146_f&fid=38266&url=http%3A%2F%2Fsleepeducation.blogspot.com%2F2010%2F07%2Ffda-warns-against-nighttime-cramp-cure.html (Source: Sleep Education) Sleep Education blogs http://www.medworm.com/rss/comments.php?id=3749856 Tue, 13 Jul 2010 16:39:00 +0100 3749856 http://www.medworm.com/index.php?rid=3750038&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FQwqFR0lWXqE%2F Also: consequences of hospital M&A activity; Medicaid cuts; ophthalmologists' honesty. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3750038 Tue, 13 Jul 2010 12:45:01 +0100 3750038 http://www.medworm.com/index.php?rid=3746739&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffor-patients-does-the-fda-play-fair%2F2010.07.12 They have a tough job, those government doctors, scientists, and bureaucrats who are charged with assessing the safety and effectiveness of proposed new medical products. As you know, they rely largely on studies presented by the applicants. The Food and Drug Administration (FDA) has the power to not approve a new drug or product or even pull it off the market. Right now it is considering limiting or pulling GlaxoSmithKline’s (GSK) diabetes drug, Avandia, because of newly discovered data that it may have caused heart attack in some patients –- data mysteriously not shown in GSK’s own studies. If the drug is pulled it will cost GSK billions of dollars in lost revenue but, from the FDA’s point-of-view, it will be protecting the public. And, after all, there are safer diabetes drugs ... Better Health blogs http://www.medworm.com/rss/comments.php?id=3746739 Mon, 12 Jul 2010 18:00:41 +0100 3746739 http://www.medworm.com/index.php?rid=3746740&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2F7-under-the-radar-healthcare-changes%2F2010.07.12 Kaiser Health News proves its value once again with an under-the-radar story covering some items you won’t see in many other news sources. An excerpt: “…several lesser-known provisions also take effect in coming months that could have a lasting impact on the nation’s health care system. These provisions include eliminating patients’ co-payments for certain preventive services such as mammograms, giving the government more power to review health insurers’ premium increases and allowing states to expand Medicaid coverage to low-income adults without children. While these changes might not have gotten at lot of attention, they could help build support for the law in the run-up to the contentious mid-term elections.” Their list: • Prevention For Less... Better Health blogs http://www.medworm.com/rss/comments.php?id=3746740 Mon, 12 Jul 2010 15:00:29 +0100 3746740 http://www.medworm.com/index.php?rid=3746717&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FdGBkXazKWxs%2F The resolution to the Avandia brouhaha will be seen as an indicator of how the FDA's new leadership handles safety concerns about drugs that are already on the market. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3746717 Mon, 12 Jul 2010 13:49:30 +0100 3746717 http://www.medworm.com/index.php?rid=3746718&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fae81qnAbQS4%2F Also: a new anti-AIDS strategy; questioning the AMA's lobbying prowess; calling for action on food-safety law. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3746718 Mon, 12 Jul 2010 12:28:40 +0100 3746718 http://www.medworm.com/index.php?rid=3743505&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F07%2F11%2Fweekly-news-round-up-another-three-day-weekend-edition%2F I’m taking Monday off work. Because I have the terrific privilege of paid vacation days, and have enough of them that I’ve actually topped out and will not accrue more until I take some of them. First, a few of my recent posts at Our Bodies Our Blog that I’ve neglected to link up here: Quick Hit: Public Comment Open on Hospital Visitation Rule Change – public comments are being accepted until August 27 on a proposed rule change that would protect patients’ rights to choose and designate their own visitors during a hospital stay and make hospital visitation much easier for LGBTQI patients and their partners HealthCare.gov Provides Tools for Understanding Health Care Options – a bit about a new government website with information on the implementation of th... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3743505 Sun, 11 Jul 2010 15:50:32 +0100 3743505 http://www.medworm.com/index.php?rid=3740822&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiDRrKRR2FKU%2F With more than a thousand pages of memos, charts and studies decipher, there are all sorts of hints, allegations and conclusions to be found in the vast treasure trove that is the set of Avandia briefing documents posted on the FDA web site this morning. For those of you with time on your hand or skin in the game, feel free to get started here and here and here. You can read about the panel members below. The meeting, of course, is a litmus test for the FDA which, under commish Margaret Hamburg, is trying to brand itself as a public health agency. With that in mind, In a briefing for the media yesterday, FDA deputy commish Josh Sharfstein maintained “we’ll make decisions in the best interest of the public” when it comes to whether Avandia is withdrawn or allowed to remain... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740822 Fri, 09 Jul 2010 19:13:50 +0100 3740822 http://www.medworm.com/index.php?rid=3740580&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fg2Zo9H2Cw_0%2F A new IOM report looks at the ethical issues surrounding trials of drugs that are already on the market. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3740580 Fri, 09 Jul 2010 13:12:56 +0100 3740580 http://www.medworm.com/index.php?rid=3737032&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fm_5vt9YuoGQ%2F Also: Blue Shield of CA sued over rates; Roche submits new breast-cancer drug to FDA; regulations on PTSD are set to change. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3737032 Thu, 08 Jul 2010 12:41:06 +0100 3737032 http://www.medworm.com/index.php?rid=3733154&cid=t_355754_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fstandards-naming-medical-devices Discussion of medical device issues has become part of the mainstream press such as last week's Boston Globe article about their security.   A year ago, I wrote about a breakthrough in medical device interoperability standards for content, vocabulary and transmission.   (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3733154 Wed, 07 Jul 2010 13:15:23 +0100 3733154 http://www.medworm.com/index.php?rid=3718633&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FLvORA0g6pU0%2F NRDC Sues FDA: The National Resource Defense Council filed a lawsuit today against the FDA for failing to take action on a petition to ban BPA in materials that come in contact with food. (via Huffington Post) Post from: BlissTree (Source: Autism Vox) Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3718633 Thu, 01 Jul 2010 20:36:21 +0100 3718633 http://www.medworm.com/index.php?rid=3718369&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F186611%2F NRDC Sues FDA: The National Resource Defense Council filed a lawsuit today against the FDA for failing to take action on a petition to ban BPA in materials that come in contact with food. (via Huffington Post) Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3718369 Thu, 01 Jul 2010 20:36:21 +0100 3718369 http://www.medworm.com/index.php?rid=3718696&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoOozbSbd4XU%2F The FDA is always under the gun, and both critics and supporters often point to a lack of funding. So how much money might be headed its way in fiscal 2011? Yesterday, the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee did a mark up and suggested $2.57 billion in funding – $55 million above the budget request. This is discretionary spending. Overall, the agency would have $3.8 billion for oversight - roughly $214 million above last year’s bill - when including $1.2 billion in user fees, notes Rosa DeLauro, the Connecticut Democrat who chairs the subcommittee, who has been harping on drug safety lately. [EDITORS' NOTE: Yes, there was a math problem earlier and we have clarified the numbers]. So the proposal include... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718696 Thu, 01 Jul 2010 13:49:21 +0100 3718696 http://www.medworm.com/index.php?rid=3718698&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh68KkPeH3gU%2F Rise and shine, everyone. Another day is on the way. This means, of course, that meetings and deadlines beckon. Never mind that a holiday weekend is just around the corner. To cope, we are brewing the mandatory cup of stimulation, and enjoying an unexpectedly cool breeze. So please join us as we peruse the news of the world. Good luck today and catch you soon… AstraZeneca Loses Bid To Overturn Antitrust Fine (Dow Jones) Biogen Names Exelisis’ George Scangos As CEO (Bloomberg News) Recession Hurts Funding For AIDS Drug Program (New York Times) FDA Issues Latest List Of Drug With Possible Risks (Reuters) Quebec To Cut Generic Drug Prices (PharmaTimes) USPTO Denies Request To Re-Examine Plavix Patent (Dow Jones) Michigan Grows CROs (Xconomy) Calistoga Raises $40M To Fund Drug Tria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718698 Thu, 01 Jul 2010 11:56:22 +0100 3718698 http://www.medworm.com/index.php?rid=3714468&cid=t_355754_167_f&fid=38271&url=http%3A%2F%2Frebeccascritchfield.wordpress.com%2F2010%2F07%2F01%2Fserving-sizes-packaged-food-nutrition-labels-may-get-a-makeover-per-the-fda%2F If you have ever read a nutrition facts label, you have probably seen the “serving size” listed right at the top. But do you know where that number comes from? (Hint, not an independent third party.) It’s actually the manufacturers themselves. Buy a big packaged muffin in the store and chances are the serving size is half a muffin. Check the cookies. The serving size is probably one or two. It’s not just junky foods either. I checked my package of alfalfa sprouts. One serving is supposedly 2/3 of the entire package. Now, I love my sprouts, but I’m lucky to get a small handful on a sandwich or salad. So why is this an issue? Well, if you haven’t heard there’s an obesity epidemic going on in the United States. We don’t get enough exercise. We don’t eat enough fruits and veg... Balanced Health and Nutrition Rebecca Scritchfield's Blog blogs http://www.medworm.com/rss/comments.php?id=3714468 Thu, 01 Jul 2010 06:06:47 +0100 3714468 http://www.medworm.com/index.php?rid=3714155&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FNUHm9ZPu3hQ%2F Also: what the FDA should do about Avandia; Merck wins a Vioxx suit; hospital pricing confusion. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3714155 Wed, 30 Jun 2010 12:27:20 +0100 3714155 http://www.medworm.com/index.php?rid=3706599&cid=t_355754_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Fdiabetes-drug-avandia-reported-increased-heart-risks%2F Two large studies published in the Journal of the American Medical Association (JAMA) detail the increased cardiovascular risks including stroke and heart attack associated with taking the diabetes drug Avandia (rosiglitazone). One of the studies was led by Dr. David Graham of the FDA. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3706599 Tue, 29 Jun 2010 04:53:48 +0100 3706599 http://www.medworm.com/index.php?rid=3706993&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNJj_HyWGF4o%2F In what may be a new get-tough program at the FDA, the agency issued a so-called untitled letter to CSL, a big maker of flu vaccines based in Australia, for flunking an April inspection that found several manufacturing deficiencies. And in addition to demanding a summary of corrective actions that must be taken, FDA officials want to meet with CSL senior execs to review their plan. The move comes less than a month after CSL recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions. However, the FDA also issued a Q&A in which the agency says the manufacting issues are unrelated to the problems that spurred the recall (background here and here). The FDA cited CSL for “a number of significant objectio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706993 Mon, 28 Jun 2010 20:42:34 +0100 3706993 http://www.medworm.com/index.php?rid=3706650&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fj9-SDBd80Ac%2F The concern is that the widespread use of antibiotics in both animals and people fosters resistance in the microbes that afflict humans. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3706650 Mon, 28 Jun 2010 19:11:02 +0100 3706650 http://www.medworm.com/index.php?rid=3699469&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FG2vXKM3NxuA%2F The public comment period on the FDA's proposed rules ends Monday. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3699469 Fri, 25 Jun 2010 21:32:10 +0100 3699469 http://www.medworm.com/index.php?rid=3695741&cid=t_355754_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2010%2F06%2Fno-more-23andme-blog-posts-sherpa-has.html I am absolutely done talking about 23andMe.Yes, you have heard correctly.That doesn't mean I will stop watching what they are doing.It means that I have coerced them into doing what's right. For now. From the very beginning 23andMe had potential, heck Dr. Jeremiah Mahoney told me they came up to Yale to see them.They must have not liked what Yale said, because they went further up the line and partnered with George Church.Well, they def. didn't like what I had to say.I had even conjectured about DTCG and what this landscape may look like and even warn about the shortcomings, I had been pointing all of you to SACGHS to watch where this regulatory environment may go. The environment was heated with these companies going in.So I knew I had to pay attention to what they were doing, especially ... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=3695741 Thu, 24 Jun 2010 23:41:00 +0100 3695741 http://www.medworm.com/index.php?rid=3695811&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5VfHt3HMgy0%2F The recent rash of recalls, which has sullied the storied Johnson & Johnson image, actually reflects a series of production gaffes that go back several years, according to a report from CNN, which collected various FDA inspection reports by filing with Freedom of Information Act requests (watch the video here). The healthcare giant actually committed several violations that were detailed in inspection reports. Of course, companies with extensive manufacturing operations are likely to commit errors now and then, but the point CNN tries to make is that a pattern appears to exist. A December 2003 inspection report noted a mislabeling problem related to some lots of children’s soft-chew Tylenol; packages listed an incorrect amount of an ingredient per tablet. McNeil did not recall t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3695811 Thu, 24 Jun 2010 13:01:04 +0100 3695811 http://www.medworm.com/index.php?rid=3695542&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F3NB220N1_s4%2F Also: docs asking the FDA for more trials of generic Lovenox candidates; health-insurance shopping made (mildly) easier. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3695542 Thu, 24 Jun 2010 12:15:48 +0100 3695542 http://www.medworm.com/index.php?rid=3690818&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FzZ31sZRP0kg%2F Also: another look at the Avandia brouhaha; small businesses and their health-insurance choices; health effects of the Gulf oil spill. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3690818 Wed, 23 Jun 2010 12:17:59 +0100 3690818 http://www.medworm.com/index.php?rid=3687100&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fherbal-remedy-for-uti-if-youre-a-lab-rat-maybe%2F2010.06.22 A patient came into the office the other day carrying a small clipping from a reputable women’s health newsletter touting new research on an herbal remedy for urinary tract infection. Having recurrent bladder infections, my patient naturally was wondering if this was something she should try. The article was entitled “Herbal Remedy Effective for Urinary Tract Infections” and began with this startling revelation: The common herbal extract forskolin can greatly reduce urinary tract infections and could potentially help antibiotics kill the bacteria that cause most bladder infections.  But the article advised that the “popular” remedy was not FDA approved for this indication, so you should “ask your doctor.” (more…) *This blog post was... Better Health blogs http://www.medworm.com/rss/comments.php?id=3687100 Tue, 22 Jun 2010 20:00:00 +0100 3687100 http://www.medworm.com/index.php?rid=3687036&cid=t_355754_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Ffda-approves-hiv-test-earlier-detection%2F The Food and Drug Administration has approved a new blood test for HIV that can detect both antigen and antibody of the HIV organism, thus allowing for earlier detection of the virus after infection. The ARCHITECT HIV Ag/Ab Combo Assay is manufactured by Abbott Laboratory. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3687036 Tue, 22 Jun 2010 19:58:39 +0100 3687036 http://www.medworm.com/index.php?rid=3687297&cid=t_355754_131_f&fid=35008&url=http%3A%2F%2Fscienceroll.com%2F2010%2F06%2F22%2Fpersonalized-genetics-fda-dtc-and-gina%2F Here are some interesting news and announcements to keep you absolutely up-to-date regarding the improvements of personalized medicine. Why 23andMe’s Sample Swap is Actually an Argument In Favor of DTC Genetic Testing There are a number of reasons why DTC genetic testing may soon find itself subject to increased federal regulatory oversight. However, 23andMe’s widely publicized data error should not be one of those reasons. In fact, the sample swap, while unfortunately timed, actually presents a compelling argument in favor of the direct-to-consumer model for genetic testing. Challenging the FDA: A History Lesson for DTC Genetics A Positive Response to Genetic Testing A personalized medicine study from the Coriell Institute for Medical Research suggests that patients who underg... ScienceRoll blogs http://www.medworm.com/rss/comments.php?id=3687297 Tue, 22 Jun 2010 15:58:44 +0100 3687297 http://www.medworm.com/index.php?rid=3683599&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FxeJChNpiWSI%2F Starting this fall, FDA recall data will be posted online in tabular and XML form. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3683599 Mon, 21 Jun 2010 20:59:40 +0100 3683599 http://www.medworm.com/index.php?rid=3679733&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F06%2F20%2Fweekly-news-round-up-inside-until-september-edition%2F It’s going to be almost 100 degrees here tomorrow; I may melt. If I didn’t have to work, I’d only go outside long enough to make a trip to Las Paletas. In the meantime, the CDC has some tips for preventing heat-related illness. Pinched Nerves has a great guest post, Gay teen blogger/book reviewer takes librarians to task over LGBT lit. The Tennessean (Nashville newspaper) has today – Nashville police drop thousands of domestic violence cases – reporting on findings of an investigation into this bit of data: “in 2005, police cleared 211 cases without making an arrest. One year later, the number jumped to 3,866, and by 2009, it was 5,600.” It examines whether officers appropriately followed up on abuse cases and whether they may have inappropriately... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3679733 Sun, 20 Jun 2010 18:25:06 +0100 3679733 http://www.medworm.com/index.php?rid=3678512&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F06%2F19%2Fat-our-bodies-our-blog-emergency-contraception-and-revisiting-vbac-standards%2F At Our Bodies Our Blog from this week, I have posts on an FDA committee’s recommendation of approval of new emergency contraception drug, and ACOG on VBAC: In Their Own Words, on recent commentaries from the ob/gyn organization’s leadership and whether they might predict a shift in professional thinking about vaginal birth after cesarean. Meanwhile, C has a post on the politics of fathering. Our Bodies Ourselves is currently working on a 40th edition of the book to be released in 2011 – the Word By Word campaign is soliciting donations to support this effort, and donors can get their name or a name of their choosing in this edition. Filed under: Access, Rights, & Choice, Birth, Contraception (Source: Women's Health News) Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3678512 Sat, 19 Jun 2010 20:02:43 +0100 3678512 http://www.medworm.com/index.php?rid=3678522&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fkl-QwNfEzmw%2F AABB took the step as an "interim measure until further definitive data are available." (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3678522 Sat, 19 Jun 2010 13:48:01 +0100 3678522 http://www.medworm.com/index.php?rid=3676757&cid=t_355754_114_f&fid=34648&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FHealthBlawg%2F%7E3%2FyRMSYqtyZV8%2Ffinal-ehr-certification-rule-announced-by-onc.html A surgeon can’t operate without the proper equipment. A clinician can’t achieve meaningful use of electronic health records without an EHR that is designed to improve patient care and practice efficiency. -- David BlumenthalToday, David Blumenthal, Steve Posnack and Carol Bean of the ONC announced the publication of the final (albeit temporary) EHR certification rule.  The actual publication date in the Federal Register will be June 24. (Here is the display copy of the EHR Certification Rule; a permanent rule will be forthcoming later this year.)The technical standards were glossed over on a conference call with ONC this afternoon; the focus, instead, was on getting testing and certification rolling.  Organizations or consortia may apply for recognition as testing and/or certific... HealthBlawg :: David Harlow's Health Care Law Blog blogs http://www.medworm.com/rss/comments.php?id=3676757 Fri, 18 Jun 2010 19:59:14 +0100 3676757 http://www.medworm.com/index.php?rid=3676891&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F06%2Fi-predicted-it-social-media-guidance.html "What had been envisioned as a massive, all-encompassing guidance on Internet promotion is being retooled as multiple guidances to address specific issues in the online realm," Tom Abrams, head of the Center for Drug Evaluation and Research's Division of Drug Marketing, Advertising and Communications (DDMAC) said during a panel discussion at the Drug Information Association's annual meeting in Washington, D.C., June 15. (Picked up from a "FDA Library Alert" email -- "DDMAC: Social Media Guidance Likely To Be Split Into Multiple Documents" -- I just received.)Either I can see into the future, or FDA reads my blog and takes my advice. In November, 2009, I said "If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3676891 Fri, 18 Jun 2010 19:35:00 +0100 3676891 http://www.medworm.com/index.php?rid=3676646&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FPR4Ksa1GD34%2F Also: the FDA approves a new treatment for prostate cancer, and one of the agency's advisory committees recommends a post-sex contraceptive pill. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3676646 Fri, 18 Jun 2010 12:22:13 +0100 3676646 http://www.medworm.com/index.php?rid=3676647&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FJC7vPTfMvVo%2F The already-approved products in the Rare Disease Repurposing Database are unique in that they've also previously received orphan-drug designation. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3676647 Fri, 18 Jun 2010 11:30:53 +0100 3676647 http://www.medworm.com/index.php?rid=3671660&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FibqMKBe_U1o%2F A NEJM Perspective piece notes that that 64% of pregnant women are already taking prescription meds for chronic or acute conditions. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3671660 Thu, 17 Jun 2010 21:16:54 +0100 3671660 http://www.medworm.com/index.php?rid=3671663&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fblg3bg8W7GA%2F Also: an econ 101 lesson for Medicare; FDA delays consideration of Merck's Gardasil for older women; more funding for alternatives to driving. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3671663 Thu, 17 Jun 2010 12:33:46 +0100 3671663 http://www.medworm.com/index.php?rid=3671664&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FBR8Ezdjz0LA%2F An FDA review says flibanserin's overall response rate isn't "particularly compelling." (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3671664 Wed, 16 Jun 2010 20:39:02 +0100 3671664 http://www.medworm.com/index.php?rid=3671890&cid=t_355754_129_f&fid=36038&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Ftrevis-life-with-multiple-sclerosis-ms%2Fms-pill-approved%2F The first oral, disease-modifying MS drug, Fingolimod, was approved for release and marketing by the FDA’s Advisory Committee on Peripheral and Central Nervous System Drugs a few days ago! I apologize for the delay my reporting such important news, but my travel schedule has been a bit nutty of late. Data was submitted earlier this year as to the efficacy and safety of the drug and the approval process took a HUGE leap on June 10 this a unanimous, 25-0 vote to allow drug maker, Novartis, to begin the next phase in the long process of bringing new drugs to market. Contacts at Novartis wouldn’t give a firm date as to the release of the drug to the US market, but it will most assuredly be available before for doctors’ prescriptions by the end of the calendar year. A .25mg dose of the dr... Life with MS blogs http://www.medworm.com/rss/comments.php?id=3671890 Wed, 16 Jun 2010 19:26:56 +0100 3671890 http://www.medworm.com/index.php?rid=3671665&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FVYeyO9RtOOQ%2F The thumbs-up rate ranges from 55% for the oncologic drugs committee all the way up to 100% for the peripheral and central nervous system drug advisory committee. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3671665 Wed, 16 Jun 2010 19:07:45 +0100 3671665 http://www.medworm.com/index.php?rid=3665971&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fflibanserin-another-pre-fda-approval-drug-hype%2F2010.06.15 This week the FDA will vote on flibanserin, the much-talked-about drug for women with the condition called hypoactive sexual desire disorder or — because everything in sexual health needs an acronym like ED or PE — HSDD. On the eve of the FDA vote, CBS last week ran still another story about flibanserin. This drug has received so much news coverage, you’d think it cures cancer. And CBS did little more than promote the hype even more, saying FDA approval “could translate into a $2 billion market in this country alone” and then failing to challenge the disease-mongering estimate of “10 percent to 30 percent of women” with this condition. It all just goes along with the drug company’s efforts to build a demand before the drug is even approved. (... Better Health blogs http://www.medworm.com/rss/comments.php?id=3665971 Wed, 16 Jun 2010 02:00:41 +0100 3665971 http://www.medworm.com/index.php?rid=3671633&cid=t_355754_87_f&fid=34470&url=http%3A%2F%2Fwww.thehealthcareblog.com%2Fthe_health_care_blog%2F2010%2F06%2Flearn-from-your-competitors-mistakes.html By MERRILL GOOZNER The Wall Street Journal (subscription required) reported last week on a Food and Drug Administration-supported effort to encourage companies to share data about their failed Alzheimer's Disease drugs. Comment: We need more of this unmarket-like behavior. Consumer... (Source: The Health Care Blog) The Health Care Blog blogs http://www.medworm.com/rss/comments.php?id=3671633 Tue, 15 Jun 2010 23:00:00 +0100 3671633 http://www.medworm.com/index.php?rid=3662649&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FtNlscWTaQf0%2F The committee said policies that evaluate donor suitability on an individual rather than group basis are needed. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3662649 Mon, 14 Jun 2010 21:55:35 +0100 3662649 http://www.medworm.com/index.php?rid=3662650&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FTKuvMF52U64%2F A member of a task force on the XMRV virus says people with chronic fatigue syndrome may be advised not to donate blood for now. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3662650 Mon, 14 Jun 2010 18:32:53 +0100 3662650 http://www.medworm.com/index.php?rid=3658939&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FGh0NVgHcyMs%2F Also: a longer-acting version of the morning-after pill; shifting prescription-drug coverage to Medicare; incentives for taking medications as directed. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3658939 Mon, 14 Jun 2010 12:18:45 +0100 3658939 http://www.medworm.com/index.php?rid=3658922&cid=t_355754_86_f&fid=38272&url=http%3A%2F%2Flaikaspoetnik.wordpress.com%2F2010%2F06%2F14%2Ffda-to-regulate-genetic-testing-by-dtc-companies-like-23andme%2F Direct-to-consumer (DTC) genetic testing refers to genetic tests that are marketed directly to consumers via television, print advertisements, or the Internet. This form of testing, which is also known as at-home genetic testing, provides access to a person’s genetic information without necessarily involving a doctor or insurance company in the process. [definition from NLM's Genetic Home [...] (Source: Laika's MedLibLog) Laika's MedLibLog blogs http://www.medworm.com/rss/comments.php?id=3658922 Mon, 14 Jun 2010 02:25:05 +0100 3658922 http://www.medworm.com/index.php?rid=3656809&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbuzzy-pain-relief-for-kids%2F2010.06.13 Here’s Buzzy, a reusable pain relief device developed by a pediatrician. It works based on the gate control theory of pain: Buzzy is a newly developed reusable pain relief device that children can bring to the doctor’s office with them to help dull the pain of shots! As the brainchild of Pediatrician Amy Baxter, Buzzy rapidly reduces pain when pressed onto the skin. Buzzy is especially helpful for children who receive shots often, like those suffering from diabetes. Buzzy can also be used for the small things, like taking splinters out! Not only is Buzzy a kid-favorite, but it’s safe, effective immediately on contact, FDA compliant, and environmentally friendly, too. *This blog post was originally published at ScienceRoll* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3656809 Sun, 13 Jun 2010 12:00:09 +0100 3656809 http://www.medworm.com/index.php?rid=3655547&cid=t_355754_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Ffda-final-decision-oral-multiple-sclerosis-drug%2F An advisory panel has recommended that the United States Food and Drug Administration give final approval for the first pill form drug to treat some forms of multiple sclerosis. The drug, named Gilenia, is being considered for use in the relapsing forms of MS. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3655547 Sat, 12 Jun 2010 01:55:48 +0100 3655547 http://www.medworm.com/index.php?rid=3652587&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2Feloa2MCbxEI%2F Wondering which products are lurking in your apartment or house that should be recalled? Here are the products that consumers should beware of – this week. It’s time to say Auf Wiedersehen to the following six safety hazards: Iams Cat Food – Proctor & Gamble voluntarily recalled some Iams canned cat food for having insufficient levels of thiamine. (Los Angeles Times blog) McDonald’s Shrek-Themed Drinking Glasses – OK, so this one was last week, but McDonald’s is still getting lots of flak for their recall of their not-so-Happy Meal toys, which contained potentially dangerous levels of cadmium, a carcinogen that can cause kidney ailments. (TIME Magazine) Beado Handheld Bead Play Toys – Rhino Toys, Inc. voluntarily recalled their toys due to a choking haz... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3652587 Fri, 11 Jun 2010 15:06:11 +0100 3652587 http://www.medworm.com/index.php?rid=3652380&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fthe-week-in-recalls-consumer-safety-hazards%2F Wondering which products are lurking in your apartment or house that should be recalled? Here are the products that consumers should beware of – this week. It’s time to say Auf Wiedersehen to the following six safety hazards: Iams Cat Food – Proctor & Gamble voluntarily recalled some Iams canned cat food for having insufficient levels of thiamine. (Los Angeles Times blog) McDonald’s Shrek-Themed Drinking Glasses – OK, so this one was last week, but McDonald’s is still getting lots of flak for their recall of their not-so-Happy Meal toys, which contained potentially dangerous levels of cadmium, a carcinogen that can cause kidney ailments. (TIME Magazine) Beado Handheld Bead Play Toys – Rhino Toys, Inc. voluntarily recalled their toys due to a choking haz... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3652380 Fri, 11 Jun 2010 15:06:11 +0100 3652380 http://www.medworm.com/index.php?rid=3652391&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FP0a10jIV_ek%2F Also: price transparency for health-care costs; production woes at drug manufacturing plants; the genetics of autism. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3652391 Fri, 11 Jun 2010 12:42:59 +0100 3652391 http://www.medworm.com/index.php?rid=3648747&cid=t_355754_135_f&fid=35262&url=http%3A%2F%2Fsurvivinghiv.blogspot.com%2F2010%2F06%2Faids-activists-support-approval-of.html (Source: Nelson Vergel's HIV Blog) Nelson Vergel's HIV Blog blogs http://www.medworm.com/rss/comments.php?id=3648747 Thu, 10 Jun 2010 14:57:00 +0100 3648747 http://www.medworm.com/index.php?rid=3648799&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSb_5e1eTnn0%2F In a stinging, 12-page letter, the FDA has scolded Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra, and neglecting to tell the agency about missing samples, some of which may have been stolen, although the FDA wasn’t always informed promptly. The May 26 warning was issued in response to a 6-week audit of Pfizer’s New York headquarters last summer. The delays in reporting adverse events go as far back as 2004 - and accelerated more recently. About 4 percent of 80,560 reports weren’t filed with the FDA on time between March 2006 and December 2008 compared with 9 percent from December 2008 to June 2009. For instance, Pfizer failed to report cases concerning V... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648799 Thu, 10 Jun 2010 12:47:54 +0100 3648799 http://www.medworm.com/index.php?rid=3648468&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FF72i7azbkv0%2F Also: new safeguards on medical radiation; a research project will disclose some genetic data to participants; overweight firefighters in Boston. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3648468 Thu, 10 Jun 2010 12:31:16 +0100 3648468 http://www.medworm.com/index.php?rid=3644745&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FCQf4U2-OsIo%2F Also: a $1.3 billion health IT merger; abortion-inducing pills via telemedicine in Iowa. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3644745 Wed, 09 Jun 2010 12:29:18 +0100 3644745 http://www.medworm.com/index.php?rid=3644946&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FzLQ_BYlg2nY%2F FDA Needs To Work on Outbreak Prevention: A new report says that the FDA is struggling to keep food safe, and should focus more of its budget on preventing foodborne illness outbreaks. Post from: BlissTree (Source: Autism Vox) Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3644946 Tue, 08 Jun 2010 20:35:39 +0100 3644946 http://www.medworm.com/index.php?rid=3644742&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F181802%2F FDA Needs To Work on Outbreak Prevention: A new report says that the FDA is struggling to keep food safe, and should focus more of its budget on preventing foodborne illness outbreaks. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3644742 Tue, 08 Jun 2010 20:35:39 +0100 3644742 http://www.medworm.com/index.php?rid=3641322&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHnRqr9lLswI%2F In the wake of the Johnson & Johnson recall scandal, almost as many questions were raised about the conduct of the FDA as there were about the behavior of the healthcare giant. During a May 27 congressional hearing, FDA deputy commish Josh Sharfstein was repeatedly asked why the agency didn’t move faster to discover and rectify the numerous quality-control problems at different J&J plants where Tylenol and Motrin are made. This prompted an interesting discussion the other day. Would the FDA have been more effective and efficient if its resources were infused with fees from drugmakers for plant inspections? After all, drugmakers pay fees for product reviews, so why not this as well? It’s not as if they don’t pay elsewhere. The UK’s Medicines and Healthcare ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3641322 Tue, 08 Jun 2010 13:38:08 +0100 3641322 http://www.medworm.com/index.php?rid=3635967&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FTrENo9lSHIs%2F How much do you really know about your health? You may think you know all the ins and outs of staying well, but our daily Health Smarts Quiz will test your knowledge on the spot. Answer our question, below, and check back tomorrow for the correct answer and your next pop quiz. photo: Thinkstock Today’s Question: Allergies make your nose run and your eyes red, but they can also affect you in surprising ways. Are you watching for the right allergy symptoms? Which of the following symptoms could be caused by allergies? Choose all that apply. #MicroPollDiv_259794 { width: 250px; margin: 0px auto; } Answer to Friday’s Question: If you want to be sun smart this summer, you’ll pick up some natural SPF without retinyl palmitate. But you can’t just slather on some sunblock... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3635967 Mon, 07 Jun 2010 15:41:10 +0100 3635967 http://www.medworm.com/index.php?rid=3635719&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Funcommon-allergy-symptoms-daily-health-quiz%2F How much do you really know about your health? You may think you know all the ins and outs of staying well, but our daily Health Smarts Quiz will test your knowledge on the spot. Answer our question, below, and check back tomorrow for the correct answer and your next pop quiz. photo: Thinkstock Today’s Question: Allergies make your nose run and your eyes red, but they can also affect you in surprising ways. Are you watching for the right allergy symptoms? Which of the following symptoms could be caused by allergies? Choose all that apply. #MicroPollDiv_259794 { width: 250px; margin: 0px auto; } Answer to Friday’s Question: If you want to be sun smart this summer, you’ll pick up some natural SPF without retinyl palmitate. But you can’t just slather on some sunblock... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3635719 Mon, 07 Jun 2010 15:41:10 +0100 3635719 http://www.medworm.com/index.php?rid=3635705&cid=t_355754_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Fattempt-to-hold-health-care-leaders.html We have frequently noted how health care organizations accused of kickbacks, fraud, and other unethical and sometimes illegal behavior involving how they produce or market health care products or services often are allowed to settle the charges only with a fines to the companies, and sometimes with corporate integrity agreements.  Almost never are the people who authorized, directed, or implemented the unethical behavior required to pay any sort of penalty.  We recently commented on a case in which an executive of a medical device company accused of exaggerating the performance of a diagnostic test in development was charged, not with misleading doctors or patients by the US Food and Drug Administration (FDA), but with misleading investors by the US Securities... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3635705 Mon, 07 Jun 2010 14:30:00 +0100 3635705 http://www.medworm.com/index.php?rid=3635744&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnutrition-and-the-government-donuts-for-freedom%2F2010.06.07 An interesting press release from the Competitive Enterprise Institute recently came across our desk and is reproduced in full below. I’m curious what our readers think of it, and of the government’s role in nutritional issues, given the link between nutrition and health: Institute Calls for Civil Disobedience on National Donut Day As Government Meddling in Nutritional Issues Mounts, CEI Advises, “Eat Two Donuts Today—One for Yourself, and One for Your Freedom” Washington, D.C., June 4, 2010 — The Competitive Enterprise Institute today urged Americans to turn National Donut Day into a day of protest against growing government intrusion into nutritional issues. CEI urged people to eat two donuts — “one for yourself, and one as an act of patriotic civil disobedience.�... Better Health blogs http://www.medworm.com/rss/comments.php?id=3635744 Mon, 07 Jun 2010 12:00:00 +0100 3635744 http://www.medworm.com/index.php?rid=3635688&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F06%2F06%2Fweekly-news-round-up-glad-its-finally-june-edition%2F Over at Our Bodies Our Blog recently, I’ve posted on the CDC’s new guide to contraceptive use safety (with relevant parts linked for easy access, as the guide itself is kind of difficult to navigate), the Defense authorization that would repeal both “don’t ask don’t tell” and prohibitions against abortions in Department of Defense medical facilities, debate about over-the-counter genetic testing, a CDC working group’s outline of a plan to address infertility, and the FDA’s transparency initiative. And, hey! this year’s 2010 Women’s Health Heroes were also announced! Big thanks to everybody who submitted nominations and/or voted – go check out the winners and inductees. Some other things that caught my eye: The Women Delive... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3635688 Sun, 06 Jun 2010 15:47:54 +0100 3635688 http://www.medworm.com/index.php?rid=3633500&cid=t_355754_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F06%2F06%2Fthe-second-agreement-dont-take-anything-personally%2F Don’t take anything personally. That’s the second agreement of Don Miguel Ruiz’s classic, “The Four Agreements.” I need a reminder today. So I open his book to that chapter and read: Whatever happens around you, don’t take it personally… Nothing other people do is because of you. It is because of themselves. All people live in their own dream, in their own mind; they are in a completely different world from the one we live in. When we take something personally, we make the assumption that they know what is in our world, and we try to impose our world on their world. Even when a situation seems so personal, even if others insult you directly, it has nothing to do with you. What they say, what they do, and the opinions they give are according to the ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3633500 Sun, 06 Jun 2010 10:35:01 +0100 3633500 http://www.medworm.com/index.php?rid=3621645&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FZ2FxnnNyc8I%2F Also: the price tag for a tobacco tax loophole; the downside of shorter hospital stays; unique research on Alzheimer's prevention. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3621645 Wed, 02 Jun 2010 12:31:52 +0100 3621645 http://www.medworm.com/index.php?rid=3618064&cid=t_355754_147_f&fid=39202&url=http%3A%2F%2Fnicolaziady.wordpress.com%2F2010%2F05%2F31%2Ffda-turns-to-social-media-to-create-transparency%2F The FDA announced last year that it is launching a Transparency Task Force, charged with “making useful and understandable information about FDA activities and decision-making more readily available to the public in a timely manner and in a user-friendly format.” The task force will seek public input on how the FDA can be more transparent, including identifying “new technologies for informing the public.” The FDA created a Transparency Blog to provide updates on the task force’s activities. Though they will be moderated, comments will be allowed on the new blog, and there are parameters around what will be posted (they are reasonable parameters that don’t appear to limit the scope of discussion). Although the FDA recently tipped its hat to Web 2.0, certainly there is much for ... Nicola Ziady blogs http://www.medworm.com/rss/comments.php?id=3618064 Mon, 31 May 2010 23:10:23 +0100 3618064 http://www.medworm.com/index.php?rid=3617947&cid=t_355754_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Fjaw-necrosis-and-fosamax-go-hand-in-hand Fosamax, a biophosphonate, is very commonly used for osteoporosis. It works by slowing bone loss and increasing bone mass, and yet did you know that it can cause jaw necrosis? fosamaxThe warning initially had been that cancer patients on the drug were more at risk, but now it seems that if you had recent dental work on infections, you are at a higher risk as well. How can this FDA approved medication be associated with pain, swelling, infection and exposed bone in the jaw? And even though the FDA approved the drug in 1995, it took them until 2008 to issue this statement: “FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the p... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617947 Mon, 31 May 2010 19:48:51 +0100 3617947 http://www.medworm.com/index.php?rid=3617948&cid=t_355754_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Ffda-approved-quinolones-can-cause-severe-disability Quinolones, basically synthetic, broad-spectrum antibiotics, are used to treat almost everything, from urinary tract infections to gynecological infections, STDs, skin infections, and respiratory infection like bronchitis, pneumonia and sinusitis.  And yet, a very well known side effect of quinolones is that it can cause tendon rupture. This can become a huge problem. Quinolones can cause tendon rupture, and someone who is just on treadmill or running while on the medication can tear their Achilles tendon. The recommendation is usually that you don’t run or jog while on the medication. How can we use something that dangerous, like Cipro, so often, when just movement while on the drug can harm you in such a way? But the FDA has known about these effects for a long time. Back in 1995, th... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617948 Mon, 31 May 2010 18:55:41 +0100 3617948 http://www.medworm.com/index.php?rid=3617949&cid=t_355754_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fproblem-solution%2Ffda-now-pushing-cholesterol-medication-with-significant-side-effects Crestor, a brand name medication, a statin to be exact, is now being touted by the Food and Drug Administration as a wonder-drug and the government agency has deemed it is safe even for healthy people to keep cholesterol down. Do you see something wrong with this? Let us take a look. Statins have two major side effects: 1. Rhabdomyolysis, which is the breakdown of muscle fibers and release of those fibers into the bloodstream. This can cause aches and pain all over the body. Rhabdomyolysis can also cause dark colored urine. If the kidneys get loaded up with these fibers, it can even cause kidney failure and death. 2. Increased Liver Enzymes: statins in the body can cause an increased production of liver enzymes, which can be linked to liver damage. Last year when a CNBC host asked why we ... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617949 Mon, 31 May 2010 18:49:10 +0100 3617949 http://www.medworm.com/index.php?rid=3610508&cid=t_355754_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F05%2Fpharmagossip-sends-fda-bad-ad.html http://www.healthyskepticism.org/global/adwatch/issue/us2010-04/Bad Ad Program (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3610508 Sat, 29 May 2010 08:35:00 +0100 3610508 http://www.medworm.com/index.php?rid=3607811&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F90th-s8CyCc%2F That’s what Ed Towns would like to see. The chair of the House Committee on Oversight and Government Reform, which yesterday held a hearing into the Johnson & Johnson recall scandal, vowed to introduce legislation that would permit the FDA to be able to conduct mandatory recalls (see this). This came after hearing how Johnson & Johnson’s McNeil Consumer Healthcare unit committed numerous violations - various pediatric meds, including Children’s Tylenol, may have contained too much active ingredient, metal specks or inactive ingredients that failed testing requirements, according to testimony by FDA deputy commish Josh Sharfstein. There were also lengthy and inexplicable delays in reporting and rectifying the problems. Moreover, a contractor was hired to surrepti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3607811 Fri, 28 May 2010 16:16:47 +0100 3607811 http://www.medworm.com/index.php?rid=3607473&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FQF2__ygzO60%2F The FDA might seek criminal penalties against J&J's McNeil Consumer Healthcare unit due to its "pattern of noncompliance" with good manufacturing practices. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3607473 Fri, 28 May 2010 14:52:50 +0100 3607473 http://www.medworm.com/index.php?rid=3607500&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhave-we-killed-clinical-research%2F2010.05.27 “…I have always depended on the kindness of strangers.”  — Blanche DuBois in Tennessee Williams’ play A Streetcar Named Desire Years ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack. Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial — the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in s... Better Health blogs http://www.medworm.com/rss/comments.php?id=3607500 Thu, 27 May 2010 16:00:00 +0100 3607500 http://www.medworm.com/index.php?rid=3603563&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F-ujxJ8lOIxk%2F Today J&J faces scrutiny from the House Committee on Oversight and Government Reform. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3603563 Thu, 27 May 2010 13:16:05 +0100 3603563 http://www.medworm.com/index.php?rid=3603564&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FmqGisa8VozU%2F Also: dangerous E. coli strains; bearing the burden of Medicaid expansion; racial differences in kids' swimming ability. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3603564 Thu, 27 May 2010 12:38:53 +0100 3603564 http://www.medworm.com/index.php?rid=3599328&cid=t_355754_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fgenzyme-settles.html In late 2009, we posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year.  We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product.  In a later post we also why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities.Now Genzyme has reached a settlement with the US Food and Drug Administration (FDA) on the matter.  As reported by the Boston Globe,Genzyme Corp will remain under federal oversight for the next seven to eight years as it works to fix quality-control problems that have bedeviled its Allston Landi... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3599328 Tue, 25 May 2010 21:42:00 +0100 3599328 http://www.medworm.com/index.php?rid=3595817&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FWNm_TCqQMt8%2F This time of year, it seems everything on the top of our minds starts with an “s”: Summer, surf, sun, and skin. And the “s” we really don’t want you to forget before frolicking in the waves? Sunscreen. But there’s a lot to consider when choosing your sunscreen; it’s not as simple as choosing a high SPF or a pretty package. Before you grab any old bottle of UV blocker off the drugstore shelf, we have a shopping checklist to make sure you get the best pick for your skin: 1. SPF – According the the Environmental Working Group, the difference between an SPF 50 and an SPF 110 is incredibly small. Also, people who choose a sunblock with a higher SPF use it as an excuse to not reapply as often as necessary. 2. Vitamin A - Though we love to load up on vi... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3595817 Tue, 25 May 2010 13:59:11 +0100 3595817 http://www.medworm.com/index.php?rid=3595551&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fsummer-skin-safety-our-sunscreen-shoppers-checklist%2F This time of year, it seems everything on the top of our minds starts with an “s”: Summer, surf, sun, and skin. And the “s” we really don’t want you to forget before frolicking in the waves? Sunscreen. But there’s a lot to consider when choosing your sunscreen; it’s not as simple as choosing a high SPF or a pretty package. Before you grab any old bottle of UV blocker off the drugstore shelf, we have a shopping checklist to make sure you get the best pick for your skin: 1. SPF – According the the Environmental Working Group, the difference between an SPF 50 and an SPF 110 is incredibly small. Also, people who choose a sunblock with a higher SPF use it as an excuse to not reapply as often as necessary. 2. Vitamin A - Though we love to load up on vi... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3595551 Tue, 25 May 2010 13:59:11 +0100 3595551 http://www.medworm.com/index.php?rid=3595559&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fz5RRkSeehe0%2F Given the time horizon involved with creating and winning approval for screening tests, some blood supply organizations are encouraging a more broad-based strategy that would zap pathogens in blood. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3595559 Tue, 25 May 2010 12:47:22 +0100 3595559 http://www.medworm.com/index.php?rid=3595895&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyacNMhGx7xk%2F Hello, again. A shiny day here on the Pharmalot corporate campus, where we expect a busy day. How about you? Much to do? We look forward to shortening our to-do list. To get started, we are quaffing the usual cup of stimulation and rummaging through the news of the world. Hope your day goes well and drop us a line if you hear anything interesting…. Astellas Hires 300 Reps In China (Bloomberg News) FDA Extends Review Of Novartis MS Drug (PharmaTimes) Abbott Labs Plans To Sell $3B In Debt (BioValley) Genzyme Agrees To $175M Consent Decree (Bloomberg News) Execs Worry About FDA’s BadAd Program (Advertising Age) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3595895 Tue, 25 May 2010 11:48:01 +0100 3595895 http://www.medworm.com/index.php?rid=3592407&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI4fZsyYZdHM%2F Most Americans believe the FDA takes too long to approve new drugs and devices, and that confidence in safety reviews is slipping, according to a new poll. Meanwhile, most say drugmakers do a good job of providing risk and safety info, as well as product awareness, but don’t listen very well to patient concerns. Many Americans also have no clue whether clinical trials are handled responsibly. Specifically, 72 percent are very confident or confident in the FDA’s safety review system, down from 74 percent in 2007. And 41 percent say the FDA approval process takes too long. However, Americans are more evenly divided about risk: 52 percent say the FDA should move more quickly to get new treatments to patients, even if it means there may be risks, while 48 percent believe the FDA sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3592407 Mon, 24 May 2010 13:19:03 +0100 3592407 http://www.medworm.com/index.php?rid=3595589&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-problem-of-drug-extinction%2F2010.05.24 Doctors are all-familiar with marketing efforts to promote new drugs, but once the new drugs displace older drugs in the medical marketplace, who serves as advocates for the continued manufacturing of older FDA-approved drugs? In a short answer: No one. For those of us dealing in cardiac arrhythmia management, this presents difficult challenges for patient care if people are unable to take the newer drugs due to side effects. These patients no longer have a fall-back option to turn to for medical therapy when the older drugs have become extinct on the marketplace. (more…) *This blog post was originally published at Dr. Wes* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3595589 Mon, 24 May 2010 12:30:00 +0100 3595589 http://www.medworm.com/index.php?rid=3590449&cid=t_355754_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2010%2F05%2Fthomas-goetz-has-wrong-debate-fda.html I think everyone in this space has been way off base as to what the problem is with FDA and Congress wanting to investigate the DTC Genomics companies. The whole mindset is wrong. What I hear from this debate is "It's my data, mine, mine, mine. Gimmee, Gimmee, you can't keep me from my data Big Brother!"From Mr Goetz's Blog"The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics." "To me, getting access to this information is a civil rights issue. It’s our data." This is a straw man argument that has been set up to make regulating these companies seem unseemly and an invasion of privacy. IT IS A DEAD WRONG ARGUMENT and I will not stand for it being perpetuated anymore. This is not about getting access to your d... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=3590449 Sat, 22 May 2010 18:49:00 +0100 3590449 http://www.medworm.com/index.php?rid=3585775&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FeH8tug-grKg%2F photo: Thinkstock Raw milk (that is, milk that’s unprocessed and non-homogenized) is thought of among some people as a natural treatment for allergies, asthma, and some stomach problems. According to The Los Angeles Times, the FDA thinks it’s dangerous to consume because of the risk of E coli and other dangerous bacteria. In fact, last March, 13 people fell ill in Michigan because of tainted raw milk. The FDA has prohibited sale of raw milk across state lines, but raw milk currently can be sold in 27 states. Proponents of raw milk, who are largely health-conscious moms, believe that they should have the right to choose what kind of milk they and their families drink. In some states, you can buy the milk in stores; in others, you have to go straight to the source – family far... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3585775 Thu, 20 May 2010 20:56:06 +0100 3585775 http://www.medworm.com/index.php?rid=3585575&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fnutrition-the-raw-milk-controversy%2F photo: Thinkstock Raw milk (that is, milk that’s unprocessed and non-homogenized) is thought of among some people as a natural treatment for allergies, asthma, and some stomach problems. According to The Los Angeles Times, the FDA thinks it’s dangerous to consume because of the risk of E coli and other dangerous bacteria. In fact, last March, 13 people fell ill in Michigan because of tainted raw milk. The FDA has prohibited sale of raw milk across state lines, but raw milk currently can be sold in 27 states. Proponents of raw milk, who are largely health-conscious moms, believe that they should have the right to choose what kind of milk they and their families drink. In some states, you can buy the milk in stores; in others, you have to go straight to the source – family far... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3585575 Thu, 20 May 2010 20:56:06 +0100 3585575 http://www.medworm.com/index.php?rid=3581847&cid=t_355754_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FyjTOvCrtT_4%2Fcenter-for-digital-democracy-brings.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3581847 Thu, 20 May 2010 13:00:00 +0100 3581847 http://www.medworm.com/index.php?rid=3577623&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjN_3H3gL_f0%2F In a bid to open a window into the way it does business, the FDA has released a Transparency Report containing 21 draft proposals for public disclosure policies. This is all part of the three-phase Transparency Initiative that was launched last year. The proposals cover such areas as adverse event reports; the docket management process; enforcement priorities and actions; import procedures; inspections; product applications; recalls and warning letters. At the end of the day, the FDA hopes this process will better explain agency decisions, provide more data to doctors and patients, “illuminate” enforcement efforts and support innovation for rare diseases. How so? If the FDA explains an abandoned application for an orphan drug could represent a significant therapeutic advance, t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577623 Wed, 19 May 2010 14:24:47 +0100 3577623 http://www.medworm.com/index.php?rid=3577376&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F4Rkm6V60mDc%2F According to a letter the company sent to physicians and poison-control officials, the medicines in question didn’t hit store shelves and batches on the market tested fine. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3577376 Wed, 19 May 2010 12:57:32 +0100 3577376 http://www.medworm.com/index.php?rid=3573941&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaTPU57Z1n1s%2F In a bid to evaluate the pharmaceutical industry’s compliance with a regulation known as 21 CFR Part 11, which is all about the growing and vast use of electronic records, the FDA is about to begin a series of so-called inspectional findings at many drugmakers. The precise timing and number of facilities to be audited - and these are audits, in effect - has yet to be determined, but they will be conducted by the FDA’s Center for Drug Evaluation and Research, or CDER. “CDER intends to use the inspectional findings to help assess how to proceed with regard to the possible modification of Part 11. CDER intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections” Robert Tollefsen, a consumer safety officer and national exp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573941 Tue, 18 May 2010 13:27:14 +0100 3573941 http://www.medworm.com/index.php?rid=3573718&cid=t_355754_105_f&fid=38964&url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F05%2Fhow-weve-killed-clinical-research.html "I have always relied on the company of strangers."- Blanche DuBois in Tennessee William's play, A Streetcar Named DesireYears ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack. Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial: the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in some small way, their fellow man.It never daw... Dr. Wes blogs http://www.medworm.com/rss/comments.php?id=3573718 Tue, 18 May 2010 10:14:00 +0100 3573718 http://www.medworm.com/index.php?rid=3573662&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FTxsLsbNCq0I%2F An official at the FDA’s Office of Orphan Products Development confirmed the designation for a form of a compound called cyclodextrin. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3573662 Mon, 17 May 2010 21:34:06 +0100 3573662 http://www.medworm.com/index.php?rid=3570061&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEFLfYWaWj5Y%2F Earlier this year, the FDA inaugurated a new panel - the Tobacco Products Scientific Advisory Committee - which was formed to review and evaluate “safety, dependence and health issues” concerning tobacco products. But it wasn’t long before there was criticism that some panel members held conflicts of interest (see here and here). At issue has been that a few of the members have ties to drugmakers that market or are developing products designed to help people quit smoking. For instance, the panel roster notes that its chair, Jonathan Samet, who is a public health expert at the UCLA, is listed as a member between 2004 and 2009 of Pfizer’s Tobacco Advisory Board, and Pfizer sells Chantix. The resume provided by Jack Henningfield, an adjunct professor at Johns Hopkins ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3570061 Mon, 17 May 2010 14:16:09 +0100 3570061 http://www.medworm.com/index.php?rid=3563958&cid=t_355754_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FUHjGKILo-L8%2F By Archelle Georgiou. On Wednesday, the FDA suddenly decided to impose their regulatory authority on personalized genetic test kits after Walgreens and Pathway Genomics announced they’d be selling them in local pharmacies. But, what triggered this response from the FDA? Are they new? No. These kits have been available to consumers via the Web for 3 years. Have they been off the regulatory radar screen? No. As far back as 2008, the rapid emergence of genetic testing fueled the passage of GINA, a federal law prohibiting health insurers and employers from discriminating on the basis of genetic information. Have these companies been quietly launching their strategy and staying invisible? No. They have made major investments in marketing with an abundant amount of media coverage in women&... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3563958 Fri, 14 May 2010 11:57:24 +0100 3563958 http://www.medworm.com/index.php?rid=3564139&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F_I3Z0MUK4j4%2F According to The New York Times, Walgreens pharmacies are holding off selling a new at-home genetic test, because the FDA just challenged legal issues surrounding the test. Post from: BlissTree (Source: Autism Vox) Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3564139 Fri, 14 May 2010 01:00:02 +0100 3564139 http://www.medworm.com/index.php?rid=3563935&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F178201%2F According to The New York Times, Walgreens pharmacies are holding off selling a new at-home genetic test, because the FDA just challenged legal issues surrounding the test. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3563935 Fri, 14 May 2010 01:00:02 +0100 3563935 http://www.medworm.com/index.php?rid=3563962&cid=t_355754_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-evolution-of-the-pill-and-its-effect-on-sex%2F2010.05.13 What role has the birth control pill played in human sexuality? Dr. Jon LaPook looks at the evolution of sex as the pill turns 50 and discusses the effect of the pill on female sexuality with sex therapist and educator Miriam Baker. Watch CBS News Videos Online Does The Pill Lower Sex Drive? The pill that ushered in the sexual revolution may have also thrown cold water on women’s libido. Fifty years ago, on May 9th, 1960, the FDA announced the approval of oral contraception. The birth control pill has allowed women to control their reproductive cycle, delay childbearing, and develop careers. But it also may have the potential to disrupt sexuality by blocking normal hormonal surges that occur in a woman’s cycle. Here’s how. (more…) (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3563962 Thu, 13 May 2010 20:00:03 +0100 3563962 http://www.medworm.com/index.php?rid=3570059&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "The Next FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").Last week I thought Google may have rescinded this exception... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3570059 Thu, 13 May 2010 12:44:00 +0100 3570059 http://www.medworm.com/index.php?rid=3566807&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "The Next FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").But Google may have rescinded this exception. Yesterday, Tyl... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3566807 Thu, 13 May 2010 12:44:00 +0100 3566807 http://www.medworm.com/index.php?rid=3560494&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fgoogle-no-longer-allows-pharma.html Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").But Google may have rescinded this exception. Yesterday, Tyler Ransbu... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3560494 Thu, 13 May 2010 12:44:00 +0100 3560494 http://www.medworm.com/index.php?rid=3560201&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FmdPySKoa7GU%2F The recommendations are part of an IOM report looking at the larger issue of how biomarkers -- things like cholesterol levels or tumor size -- should be judged in studies and health and safety claims. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3560201 Wed, 12 May 2010 17:09:36 +0100 3560201 http://www.medworm.com/index.php?rid=3556373&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhMiG48LwPMA%2F Yesterday, the FDA launched what it calls a new educational outreach effort to encourage doctors and other healthcare providers to report misleading prescription drug promotion and provide them with an easy way to report this activity to the agency’s DDMAC, the Division of Drug Marketing, Advertising, and Communications, which issues warning letters for violations. The hope for the BadAd program is that drugmakers will toe the line and curtail promotional efforts that go too far. We spoke with Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, about the program… Pharmalot: Do you think the program is warranted? Friede: From the FDA’s prepecrtive, we are see an ongoing and even increasing amount of correspondence from DDMAC,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556373 Wed, 12 May 2010 13:17:06 +0100 3556373 http://www.medworm.com/index.php?rid=3556378&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfAGgDJ3OVfM%2F If you’re a doctor, the FDA wants your help in identifying ‘bad’ advertisements for prescription drugs. Seriously. The agency is calling it’s new ‘Bad Ad’ program an educational outreach effort and, not surprisingly, it’s being run by DDMAC, the agency’s Division of Drug Marketing, Advertising, and Communications, which issues all those warning letters and violations. The goal of the program is to “help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” DDMAC director Tom Abrams says in a statement. Usually, the FDA finds ‘bad ads’ by reviewing promotional materials submitted for agency review, fielding complaints (often one company s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556378 Tue, 11 May 2010 17:26:52 +0100 3556378 http://www.medworm.com/index.php?rid=3549589&cid=t_355754_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F62%2Fiv-glutathione-for-skin-whitening%2F Due to the success of oral Glutathione capsules comes a new and supposedly faster way to whiter skin – IV Glutathione – where the antioxidant is injected directly into the vein and into the bloodstream. This way the patient gets a higher dose which lead to quicker results.  Usually the injections are done twice a week for a total of 10 sessions each. Again, this is not FDA approved but despite this fact, patients flock to their dermatologist/plastic surgeon’s office to get their weekly dose. Frankly, I’m not a believer of IV Glutathione and I’m not too wild about the idea of having a drug without any good studies to back it up injected in my vein. I’d rather rely on the good old and dependable sunscreen on top of chemical exfoliants. Related Posts:Glutathione for Skin ... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3549589 Mon, 10 May 2010 15:50:51 +0100 3549589 http://www.medworm.com/index.php?rid=3545429&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Ft6is2nsrqYo%2F E. coli has sickened at least 19 people in 3 states, leading to a recall of shredded romaine lettuce. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3545429 Fri, 07 May 2010 20:56:51 +0100 3545429 http://www.medworm.com/index.php?rid=3538072&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FHnfOG3IcGRQ%2F Children's cough and cold meds got a lot of attention in 2007, when pediatricians petitioned the FDA to review the effects of the drugs in kids. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3538072 Wed, 05 May 2010 17:40:41 +0100 3538072 http://www.medworm.com/index.php?rid=3533808&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FYpf_sfhtx5o%2F Yesterday the FDA said that an April inspection of the problematic plant had turned up raw materials contaminated by certain bacteria that may cause infections. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3533808 Wed, 05 May 2010 12:21:25 +0100 3533808 http://www.medworm.com/index.php?rid=3534028&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2FXUhD4Vhq61U%2F Happy birthday in advance to the pill! (It turns 50 this weekend.) Not only did the birth control pill revolutionize women’s sexuality, but it also meant major changes for F.D.A.’s regulation practices, according to today’s New York Times. Post from: BlissTree (Source: Autism Vox) Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3534028 Wed, 05 May 2010 03:21:26 +0100 3534028 http://www.medworm.com/index.php?rid=3533799&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F177144%2F Happy birthday in advance to the pill! (It turns 50 this weekend.) Not only did the birth control pill revolutionize women’s sexuality, but it also meant major changes for F.D.A.’s regulation practices, according to today’s New York Times. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3533799 Wed, 05 May 2010 03:21:26 +0100 3533799 http://www.medworm.com/index.php?rid=3533810&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FbEuo6eJ_Kjg%2F Novartis was warned about two websites it sponsors that didn't mention the name of Gleevec, the drug the sites were promoting. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3533810 Tue, 04 May 2010 20:29:29 +0100 3533810 http://www.medworm.com/index.php?rid=3534133&cid=t_355754_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F46%2Fglutathione-for-skin-whitening%2F Glutathione is a natural antioxidant that gets rid of harmful substances in our body like free radicals and reactive oxygen species. Manufacturers claim that it’s skin lightening property works by shifting the production of eumelanin (which is the brown/black pigment of the skin) to pheomelanin (yellow/red pigment). This shift in production to a lighter type of melanin becomes visible as whiter skin. Basically, glutathione is a supplement, not a drug. It has been categorized by the FDA as generally regarded as safe (GRAS). No definitive studies have been done to really evaluate the efficacy and safety of glutathione as an oral skin whitening agent. However, there are a lot of testimonials and apparently the people whom I know have taken the supplement are happy with the results. They rep... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3534133 Tue, 04 May 2010 17:28:56 +0100 3534133 http://www.medworm.com/index.php?rid=3529757&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FOcjF-cd2udQ%2F Susan Bayh, a company director and wife of Sen. Evan Bayh, netted nearly $2.5 million. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3529757 Tue, 04 May 2010 14:28:51 +0100 3529757 http://www.medworm.com/index.php?rid=3519435&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FSv-6o5MdEAw%2F The approval comes after Dendreon resubmitted its application for the novel treatment late last year. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3519435 Thu, 29 Apr 2010 21:15:39 +0100 3519435 http://www.medworm.com/index.php?rid=3519653&cid=t_355754_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2010%2F04%2Ffda-approves-provenger-for-the-treatment-of-men-with-advanced-prostate-cancer%2F SEATTLE, April 29, 2010 –Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has approved PROVENGE(R) (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=3519653 Thu, 29 Apr 2010 20:24:33 +0100 3519653 http://www.medworm.com/index.php?rid=3511776&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiKJQxS2m-mc%2F Earlier this month, the FDA sent Pfizer a warning letter for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and a serious skin disorder. This is a big problem for the drugmaker, since Pfizer hopes to receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials. But the dosing scandal could prompt the FDA to request further trials, which would require so much additional time that exclusivity would likely be lost, since the basic Geodon patent expires in 2012. This would also delay pediatric approval, which would expand the possibilities for a drug that generated $1.1 billion in sales last year. But who ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511776 Wed, 28 Apr 2010 13:58:00 +0100 3511776 http://www.medworm.com/index.php?rid=3508162&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FbT9tLFUKaGQ%2F An FDA spokeswoman says the agency received nearly 3,000 submissions from the public on the new rules, “significantly more” submissions than usual. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3508162 Tue, 27 Apr 2010 12:03:26 +0100 3508162 http://www.medworm.com/index.php?rid=3508306&cid=t_355754_117_f&fid=38856&url=http%3A%2F%2Fwww.timemastermd.com%2F%3Fp%3D932 FDA!  No Lick, Just Sip & Suck? For thousands of years, salt’s high value has made it the foundation of a society, a currency of trade, and cause for wars.  Now suddenly salt is the bad girl.  An organized push by the FDA to ban salty foods and have manufacturers reduce salt in their products, is fueled by idiots who know nothing about health and those who ignore the US Constitution!   So if the FDA get’s it way, and outlaws salt – what happens to #1?  I guess we tequila drinkers will just have to make do with number 2 and 3!                  Consumers love the taste of salt in food and, in fact, their bodies crave it. With the trend toward low-fat foods, food producers must rely on salt to provide the desired taste.   So, what do you think will hap... Timemaster MD blogs http://www.medworm.com/rss/comments.php?id=3508306 Mon, 26 Apr 2010 19:24:51 +0100 3508306 http://www.medworm.com/index.php?rid=3502831&cid=t_355754_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F25%2Fultrawellness-or-ultra-hype-antidepressant-as-demagogue%2F Mark Hyman, MD, is a “practicing physician and pioneer in functional medicine,” according to his bio on the Huffington Post where he recently penned the nonsensical, “Why Antidepressants Don’t Work for Treating Depression.” I say “nonsensical” because this article is based upon a study that came out 3 years ago, so writing this article to educate the public seems not to be its primary purpose. Exhibiting sound reasoning and logic also doesn’t seem apparent in this article, since generally a scientist or doctor would not dismiss an entire class of medications — antidepressants — based upon a single study. Or when there are many different types of antidepressants and sub-classes — SSRIs, tricyclics, MAOIs, SRNIs, etc. The stud... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3502831 Sun, 25 Apr 2010 15:45:16 +0100 3502831 http://www.medworm.com/index.php?rid=3494550&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZAyqYFm0i5k%2F This is long overdue. In a bid to appear transparent, the agency is issuing a draft guidance that would expand disclosure when a conflict of interest waiver is granted to individuals who participate in its advisory committee meetings. The expanded disclosure about waivers would occur prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest. Typically, the agency redacts or omits info so that the nature of any possible conflict is difficult if not impossible to ascertain. There are 49 committees, by the way, and some 600 participants. This doesn’t mean the FDA will turn its nose at all conflicts. In a letter to agency staff, FDA commish Margaret ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3494550 Thu, 22 Apr 2010 12:17:01 +0100 3494550 http://www.medworm.com/index.php?rid=3490728&cid=t_355754_114_f&fid=34648&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FHealthBlawg%2F%7E3%2FN0rw9xKpgWg%2Ffda-radiation-therapy-emitting-equipment-regulation-ehr-device.html Earlier this month, the FDA released a letter announcing a new focus on radiation-emitting products.  Here's the core of the letter:In order to reduce the number of under-doses, over-doses, and misaligned exposures from therapeutic radiation the FDA is taking several steps to improve the safety and safe use of certain radiation therapy devices. Analyses of Medical Device Reports (MDRs) revealed device problems that appear to be the result of faulty design or use error that could be mitigated by the incorporation of additional safeguards. Between December 31, 1999, and February 18, 2010, FDA received 1,182 MDRs associated with the use of radiation therapy devices. Of these MDRs, linear accelerators accounted for 74%, radiation therapy treatment planning systems (RTP) accounted for 19%, and... HealthBlawg :: David Harlow's Health Care Law Blog blogs http://www.medworm.com/rss/comments.php?id=3490728 Wed, 21 Apr 2010 13:59:06 +0100 3490728 http://www.medworm.com/index.php?rid=3487030&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F82RltHiKg_U%2F A report coming out tomorrow will recommend that the government intervene to put limits on the amount of sodium in food, and the FDA will act on that advice, the Washington Post reports. Citing anonymous FDA sources, the paper says the agency is aiming to work with manufacturers on a step-down approach, in which salt would be subtracted in small increments over a decade. The hope is that the phase-out will be unnoticeable to consumers. The limits aren’t yet decided, and it’s not yet known whether inherently salty foods, like pickles, will get an exemption. Such a reduction will be recommended by the Institute of Medicine, which Wednesday will release a report that says merely encouraging manufacturers to cut salt hasn’t succeeded in curbing U.S. daily sodium consumption, now about twice... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3487030 Tue, 20 Apr 2010 12:25:18 +0100 3487030 http://www.medworm.com/index.php?rid=3483116&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fvoltaren-adherence-email-gets-fda.html As of April 15, 2010, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent out 5 "notice of violation" (aka "warning") letters to drug companies regarding various promotional pieces. One letter is of interest because it concerns a direct-to-consumer (DTC) adherence "wave 5 e-mail" ("Adherence Email") for Voltaren, an NSAID topical gel marketed by Novartis. This may be the FIRST FDA warning letter issued for an email promotion. But is it justified?Among other violations, the letter cites "minimization of risk information." The letter (find it here) states:"The Adherence Email prominently presents efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space. In contrast, the risk information is relegate... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3483116 Mon, 19 Apr 2010 12:59:00 +0100 3483116 http://www.medworm.com/index.php?rid=3482880&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FFCvJJy2DCZI%2F The FDA is considering cutting short a trial comparing the safety of two diabetes drugs — GlaxoSmithKline’s Avandia and Takeda’s Actos, the WSJ reports. Given that Avandia has been linked since 2007 to an increased risk of heart attacks, some scientists have said it’s not ethical to put study participants at risk. If the trial is stopped, the FDA will also consider asking Glaxo to stop selling the drug. Joshua Sharfstein, principal deputy commissioner of the FDA, tells the WSJ that no decision on the trial (called TIDE) has been made yet, and won’t be until after a July meeting about the drug. By then the agency will also have the results of an Institute of Medicine review examining the appropriateness of such head-to-head safety trials. The study’s principal investigator says i... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3482880 Mon, 19 Apr 2010 12:08:13 +0100 3482880 http://www.medworm.com/index.php?rid=3483120&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYtTuaEgi9dM%2F For those tracking the missives sent by the agency to drugmakers, here is a quick round-up of letters that were posted late last week on the FDA web site. Interestingly, two of the violations involve a web page and an email. GlaxoSmithKline was tagged for placing an ad in the Dec. 1, 2009, issue of the Journal of Clinical Oncology that was cited for being false and misleading for omitting safety and effectiveness info about Arzerra (here’s the letter and here’s the ad). In another letter, sent to Astallas Pharma and Glaxo, which have a partnership to promote the Vesicare bladder control drug, the FDA charged that a web site promotion is “false or misleading because it presents unsubstantiated superiority claims and overstates efficacy” (here’s the letter and the w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3483120 Mon, 19 Apr 2010 11:51:35 +0100 3483120 http://www.medworm.com/index.php?rid=3480778&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F04%2F18%2Fweekly-news-round-up-418%2F At RHRC, Robin Marty has a rundown of states working to ban abortion coverage in health exchanges related to health reform legislation. This includes Tennessee, where HB 2681 has passed the state House and would “prohibit[s] coverage for abortion services under any health care plan through an exchange required to be established in this state pursuant to federal health care reform legislation.” More locally, Speak to Power talks about concerns that have been raised about whether this bill could limit contraception coverage as well. My understanding is that local liberal talk radio show Liberadio(!) will be discussing the issue in their Monday show as well. Speaking of Tennessee, the Unnecesarean has some summary c-section rates by hospital for the state. I’m really curio... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3480778 Sun, 18 Apr 2010 15:46:17 +0100 3480778 http://www.medworm.com/index.php?rid=3472042&cid=t_355754_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_kUri2r0rAo%2F If at first you don’t succeed….screw up again? That seems to be the pattern at Apotex, which was issued yet another warning letter by the FDA for significant violations of the good manufacturing practices for finished pharmaceuticals. The latest warning refers to problems found at the generic drugmaker’s Toronto plant, while a June 2009 letter cited a facility in Etobiocoke, Canada. Basically, Apotex offers a blueprint on how not to make drugs. In its latest missive, the FDA notes there were identical violations at both plants that “demonstrated a lack of adequate process controls and raised serious questions regarding…quality and production systems.” Both sites were placed under an import alert last August, by the way, and Apotex recalled 659 batches o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3472042 Thu, 15 Apr 2010 13:12:32 +0100 3472042 http://www.medworm.com/index.php?rid=3468017&cid=t_355754_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fpre-screening-post-screening-or-no.html Discussions to 3rd Parties"). But I am on the fence regarding pre- vs. post-screening. A few organizations that submitted comments to the FDA in response to its questions about regulating pharma's use of social media addressed the issue of moderation (see, for example, "Accountability for Pharma Content on Social Media Sites"). LiveWorld, Inc. -- a social marketing agency with 20+ years creating, operating, and moderating online communities -- submitted the most detailed comments regarding moderation (find LiveWorld's comments here). In tomorrow's Pharma Marketing Talk LIVE podcast ("Online Community Management Moderation Best Practices & Other Tips for Pharma Social Media Managers"), I will be interviewing Jenna Woodul, who is the co-founder and Chief Community Officer of LiveWorld. J... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3468017 Wed, 14 Apr 2010 13:18:00 +0100 3468017 http://www.medworm.com/index.php?rid=3460147&cid=t_355754_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FxRYXT351s-c%2F The recent history of a medicine used to treat gout provides another chapter in the book of unintended consequences. We’ll recount some highlights of the tale as spelled out in this morning’s WSJ: A common gout drug, colchicine, has been around for so long that pre-dated the FDA and until last year, it had never been approved by the agency. As part of a push by the FDA to bring such drugs under its umbrella, a company called URL Pharma commissioned studies to show that colchicine was safe and effective, and last summer the FDA approved the company’s version and gave URL three years of marketing exclusivity for the drug. Here come the unintended consequences. While the FDA says it hoped there wouldn’t be a significant run-up in the price of colchicine — sold as... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3460147 Mon, 12 Apr 2010 14:31:32 +0100 3460147 http://www.medworm.com/index.php?rid=3460395&cid=t_355754_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=3460192&cid=t_355754_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FoCES-A55Jxw%2Ffda-looking-at-triclosan.html The Washington Post had a story by Lyndsey Layton this past week:  FDA says studies on triclosan, used in sanitizers and soaps, raise concerns. The Food and Drug Administration said recent research raises "valid concerns" about the possible health effects of triclosan, an antibacterial chemical found in a growing number of liquid soaps, hand sanitizers, dishwashing liquids, shaving gels and even socks, workout clothes and toys. The FDA and the Environmental Protection Agency say they are taking a fresh look at triclosan, which is so ubiquitous that is found in the urine of 75 percent of the population, according to the Centers for Disease Control and Prevention. The reassessment is the latest signal that the Obama administration is willing to reevaluate the possible heal... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=3460192 Mon, 12 Apr 2010 11:01:00 +0100 3460192 http://www.medworm.com/index.php?rid=3460118&cid=t_355754_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2010%2F04%2F11%2Fsunday-news-round-up-back-online-edition%2F I’m finally back online at home! While I’ve been away, I’ve learned adult/child CPR/AED use and infant CPR, registered to be an organ donor, listened to a lot of classical music on the radio courtesy of the local public radio station, played a lot of Rummy and lost at Lord of the Rings Trivial Pursuit (as usual), had my first lunch at Swett’s, and read B is for Beer, Warbreaker, War Dances, The Lassa Ward and half of Middlemarch. Here are some things that transpired or were written with style in the interim. First, Our Bodies Ourselves is accepting nominations for the 2010 Women’s Health Heroes awards. Nominations are due by the end of this month, so make yours today! OBOS has also launched the Word by Word campaign, in which a donation to support the organi... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=3460118 Sun, 11 Apr 2010 17:02:34 +0100 3460118 http://www.medworm.com/index.php?rid=3456910&cid=t_355754_167_f&fid=38271&url=http%3A%2F%2Frebeccascritchfield.wordpress.com%2F2010%2F04%2F10%2Fdo-you-know-whats-in-your-dietary-supplements%2F Are you one of the 14 million Americans who takes dietary supplements? If you are taking supplements to help you lose weight, please do your homework first. According to this story in the New England Journal of Medicine, you may be getting way more than you paid for. “A police offer who had been encouraged by his doctor decided to try a weight-loss supplement to help him shed his extra pounds. But instead of losing weight, he lost his job. His diet pills, which were imported from Brazil and sold in the United States, contained vitamin E, centella, senna, and cascara, among other “natural” ingredients. Not included on the label was the amphetamine detected in his urine drug screen. The now-unemployed sergeant is not alone. Such contaminated supplements represent an emerging risk to p... Balanced Health and Nutrition Rebecca Scritchfield's Blog blogs http://www.medworm.com/rss/comments.php?id=3456910 Sat, 10 Apr 2010 09:11:17 +0100 3456910 http://www.medworm.com/index.php?rid=3454103&cid=t_355754_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F2-JNonvlWTA%2F Think Before You Soap: The FDA is investigating health effects of triclosan, a popular anti-bacterial agent which studies show has possible negative health effects. It’s found in many soaps and hand sanitizers, and according to the Centers for Disease Control and Prevention, it’s found in 75% of the population’s urine. Yikes! Post from: BlissTree (Source: Autism Vox) Autism Vox blogs http://www.medworm.com/rss/comments.php?id=3454103 Fri, 09 Apr 2010 16:00:10 +0100 3454103 http://www.medworm.com/index.php?rid=3453867&cid=t_355754_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F173957%2F Think Before You Soap: The FDA is investigating health effects of triclosan, a popular anti-bacterial agent which studies show has possible negative health effects. It’s found in many soaps and hand sanitizers, and according to the Centers for Disease Control and Prevention, it’s found in 75% of the population’s urine. Yikes! Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3453867 Fri, 09 Apr 2010 16:00:10 +0100 3453867