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 'effexor'. Sat, 03 Sep 2011 02:09:29 +0100 http://www.medworm.com/index.php?rid=4747887&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FScX2CHW6fmI%2F Welcome back, everyone. Nice to see you again after a much-needed break. Hope your own time off was pleasant. Now, of course, the routine of meetings and deadlines has returned. To cope, we are brewing a mandatory cup of stimulation - our flavor today is Wild Mountain Blueberry. Please join us as we catch up with the recent news of the world. And so, here are some tidbits to help your day get started. Stay in touch… FDA Staff Raises Safety Concern With Merck Hepatitis C Drug (Reuters) Vertex Hopes FDA Panel Will OK Its Hep C Treatment (Boston Globe) AstraZeneca To Demolish R&D Facility (Delaware Online) Eisai Aricept Patch For Alzheimer’s Fails To Win FDA Approval (Bloomberg News) Sun Pharma To Sell Merck Diabetes Drugs In India (Reuters) Dr. Reddy’s To Sell Pfizer A... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747887 Mon, 25 Apr 2011 12:01:51 +0100 4747887 http://www.medworm.com/index.php?rid=4399796&cid=t_110560_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F26%2Fpotential-ssrisnri-withdrawal-symptoms%2F The SSRI/SNRI symptoms are originally from this website on Effexor withdrawal. ANTIDEPRESSANT WITHDRAWAL SYMPTOMS. (SSRI/SNRI) 1. Crying spells 2. Worsened mood 3. Low energy (fatigue, lethargy, malaise) 4. Trouble concentrating 5. Insomnia or trouble sleeping 6. Change in appetite 7. Suicidal thoughts 8. Suicide attempts 9. Anxious, nervous, tense 10. Panic attacks (racing heart, breathless) [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4399796 Wed, 26 Jan 2011 18:02:06 +0100 4399796 http://www.medworm.com/index.php?rid=4389181&cid=t_110560_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Flexapro-for-treatment-of-hot-flashes%2F2011.01.23 In a well done placebo-controlled study published in this week’s Journal of the American Medical Association (JAMA), use of escitalopram (Lexapro) reduced hot flashes in menopausal women. Investigators enrolled 205 women, randomizing them to either Lexapro 10 mg or placebo, with instructions to increase to two pills a day if needed after four weeks. Lexapro users experienced about a 60 percent reduction in hot flash frequency over the eight-week study. About half ended up on the larger 20 mg daily dose by study’s end. The drug’s effect was apparent at about one week of use, and it was well tolerated. As in almost studies of menopausal treatments, the placebo group also experienced a significant reduction in symptoms — about 40 percent — but the difference between place... Better Health blogs http://www.medworm.com/rss/comments.php?id=4389181 Sun, 23 Jan 2011 23:00:21 +0100 4389181 http://www.medworm.com/index.php?rid=4098464&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIAF1KmZPK2w%2F Good morning, everyone. The end of the week is rapidly approaching and that usually means one thing - daydreaming about weekend plans. We expect to catch up on a few chores, but will spend most of our time entertaining the shortest of short people with a little bowling and ice cream, and a trip to the book store. What about you? A drive in the country to watch the leaves change? Toss a football? Pick a pumpkin? Walk your own official mascots? Whatever you do, have a good time and be safe. See you soon… EMA Revises Stance On Genzyme’s Fabrazyme (Reuters) Wyeth Must Disclose Earlier Effexor XR Patent Settlements (New Jersey Law Journal) Amgen Exec Retires And Gets $400K Consulting Deal (SEC filing) FDA Adds Heart Warning To HIV Drug Combo (Associated Press) Roche And Biogen End D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098464 Fri, 22 Oct 2010 12:06:06 +0100 4098464 http://www.medworm.com/index.php?rid=3710798&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPlw3NtaReH4%2F Top of the morning to you. Another balmy day here on the Pharmalot corporate campus, where an usual quiet has set in now that the short people are busy with their summer activities. We are keeping busy, of course, sifting through documents. And you? Projects and meetings beckon, no doubt. To cope, please join us for a cup of stimulation and a peek at a few interesting items. Have a nice day, everyone… Bayer Drops One Patent Infringement Case Over Yaz (Reuters) Novartis Can’t Force Alcon Merger (PharmaTimes) Teva Gets FDA OK For Generic Effexor XR (Reuters) UK’s NICE Reverses Decision On Rheumatoid Arthritis Meds (PharmaTimes) Speeding Clinical Trial Recruitment With E-records (Outsourcing Pharm) Abbott Puts Solvay Flu Biz Up For Sale (The Wall Street Journal) Taro Pharma ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710798 Tue, 29 Jun 2010 11:45:35 +0100 3710798 http://www.medworm.com/index.php?rid=3699704&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9uSkJUlkuGQ%2F Scott Reuben, who was accused of faking research for a dozen years in published studies that suggested after-surgery benefits from Vioxx and Celebrex, was sentenced to six months in jail plus three years supervised release after he pleaded guilty earlier this year to health care fraud, MassLive reports. The 51-year-old must also repay $361,932 in research grants, forfeit assets worth at least $50,000 and pay a $5,000 fine. The former chief of acute pain at Baystate Medical Center received grants from various drugmakers but never performed the studies, fabricated patient data and submitted info to anesthesiology journals that was unwittingly published. Later, an investigation found 21 papers published in journals between 1996 and 2008 in which Reuben made up some or all of the data (backgr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699704 Fri, 25 Jun 2010 12:45:58 +0100 3699704 http://www.medworm.com/index.php?rid=3621952&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmNXqm9NGrP0%2F Any of the commonly used antidepressants was associated with a 68 percent relative increase in the overall risk of a miscarriage, and there were significant associations with the use Pfizer’s Effexor and GlaxoSmithKline’s Paxil, according to a study in the Canadian Medical Association Journal. Also worth noting: the use of more than one class of antidepressant doubled the risk. The study examined 5,124 women who suffered miscarriages. A total of 284, or 5.5 percent of the women who had a miscarriage had at least one prescription for an antidepressant filled during pregnancy, compared with 1,401, or 2.7 percent of the matched control group. The authors noted that previous studies yielded inconsistent findings. There have also been lawsuits over links between Glaxo and birth defe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621952 Wed, 02 Jun 2010 12:51:21 +0100 3621952 http://www.medworm.com/index.php?rid=3618087&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeIKSx7mehTc%2F This isn’t surprising. A new survey finds that 78 of those seeking treatment for depression or anxiety were prescribed antidepressants, but roughly half of those taking such a pill report being helped ‘a lot.’ Meanwhile, 91 percent of respondents who stuck with ‘talk therapy, reported this approach made things “a lot” or “somewhat” better, according to Consumer Reports, which conducted the survey. The survey also found that older, often less expensive SSRI antidepressants - selective serotonin reuptake inhibitors such as Lexapro, Celexa, Prozac and Zoloft - work just as well, and with fewer side effects, than newer, more costly SNRIs, including Cymbalta and Effexor (see Consumer Reports cost data here). Last year, doctors prescribed $9.9 billion worth of ant... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3618087 Tue, 01 Jun 2010 15:31:11 +0100 3618087 http://www.medworm.com/index.php?rid=3592408&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdHy_o-316kw%2F Here’s a finding that’s likely to cause a sticking point for Pfizer. Acupuncture worked as well as Effexor in combating hot flashes and other menopausal symptoms that can accompany breast cancer treatments, and its benefits last longer without causing side effects, according to research presented at an American Society for Therapeutic Radiology and Oncology meeting in Boston After 12 weeks of treatment, symptoms such as hot flashes and night sweats were reduced for 15 additional weeks for women who had undergone acupuncture, compared with two weeks for those who had taken Effexor, which is best known as an antidepressant. “It was a more durable effect,” lead researcher Eleanor Walker of Henry Ford Hospital in Detroit tells Reuters. The patients who were treated wit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3592408 Mon, 24 May 2010 12:12:17 +0100 3592408 http://www.medworm.com/index.php?rid=3374376&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEjbcJQRV5rM%2F The Special Committee on Aging wants to know why there are “large discrepancies” between the prices charged for meds in the US and other industrialized countries. So letters were sent to six drugmakers - AstraZeneca, Pfizer, Lilly, GlaxoSmithKline, Novartis and Sanofi-Aventis - to explain why drugs can cost up to four times more in the US (click each name to see the letters). And the hearing, which is called ‘Seniors Feeling the Squeeze,’ starts at 2:30 pm EST today. The letters note that US consumers spend an average of $878 a person on meds, compared with $446 a person in other industrialized countries, and then cite specific examples of differences in price. For instance, AstraZeneca’s Nexium costs $3.91 in the US compared with $1.32 in the UK and 88 cents ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3374376 Wed, 17 Mar 2010 12:15:17 +0100 3374376 http://www.medworm.com/index.php?rid=3298596&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKOaY5HiIh4o%2F Scott Reuben, who was accused of faking research for a dozen years in published studies that suggested after-surgery benefits from Vioxx and Celebrex, pleaded guilty yesterday to one count of federal health care fraud. The 51-year-old anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty, the Associated Press reports. Prosecutors alleged the former chief of acute pain at Baystate Medical Center received grants from various drugmakers but never performed the studies, fabricated patient data and submitted info to anesthesiology journals that was unwittingly published. Later, an investigation found 21 papers published in journals between 1996 and 2008 in which Reuben made up some or all of the data (background here and here). The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3298596 Tue, 23 Feb 2010 12:41:43 +0100 3298596 http://www.medworm.com/index.php?rid=3185620&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcXg3NJ5cmOI%2F Scott Reuben is on the hook for nearly $300,000 for faking research he conducted on various meds. The former chief of acute pain at Baystate Medical Center in Springfield, Ma., sought and received research grants from Pfizer and other drugmakers but never performed the studies. He fabricated patient data and submitted info to anesthesiology journals that unwittingly published it. Reuben must also pay $16,000 in restitution to Wyeth, which is now owned by Pfizer, and $49,375 to Merck (see documents here). You may recall that, last week, federal prosecutors filed a health care fraud charge against Reuben, who is accused of faking research for a dozen years in published studies suggesting Vioxx and Celebrex offered benefits after surgery. Reuben agreed to plead guilty in exchange for a recomm... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3185620 Tue, 19 Jan 2010 13:07:40 +0100 3185620 http://www.medworm.com/index.php?rid=3176117&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM-pTZd9IiDQ%2F Federal prosecutors filed a health care fraud charge against Scott Reuben, who is accused of faking research for a dozen years in published studies suggesting Vioxx and Celebrex offered benefits after surgery. Court documents indicate Reuben, an anesthesiologist, agreed to plead guilty in exchange for a recommendation of a more lenient jail sentence of up to 10 years, a $250,000 fine and forfeiture of assets worth at least $50,000 received for the research, the Associated Press reports. Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield, Ma., sought and received research grants from drugmakers but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, the AP writes,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3176117 Fri, 15 Jan 2010 13:11:05 +0100 3176117 http://www.medworm.com/index.php?rid=3142831&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYDsWID7KjMQ%2F In an attempt to dissect the profitability of big drugs - and gauge their contribution to a drugmaker’s overall profit and loss - Sanford Bernstein analyst Tim Anderson recently crunched some numbers showing, among other things, that roughly 30 of the 52 drugs he examined have pretax margins that are 70 percent or higher. This compares to the average drug company pretax margin of about 32 percent. His point: a big drug may only account for 10 percent of a company’s total sales, but its contribution to pretax profits could be twice as large. And as patent cliffs loom, this is important. Here are the drugs offering the biggest payback: 1 - Effexor (Pfizer) 87 percent 2 - Arimidex (AstraZeneca) 85 percent 3 - Femara (Novartis) 84 percent 4 - Detrol (Pfizer) 84 percent 5 - Gemzar ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3142831 Tue, 05 Jan 2010 14:44:08 +0100 3142831 http://www.medworm.com/index.php?rid=2996010&cid=t_110560_137_f&fid=35426&url=http%3A%2F%2Funcnews.unc.edu%2Fimages%2Fstories%2Fnews%2Fhealth%2F2008%2Fdrugslist.pdf Falls are the leading cause of both fatal and nonfatal injuries for adults sixty-five and older, and research suggests that those taking four or more medications are at an even greater risk than those who don’t—perhaps two to three times greater. -- Susan Blalock, UNC Eshelman School of Pharmacy.....Bob DeMarco Alzheimer's Reading Room Editor I am always worried that my mother might fall and injure herself -- or worse. Research studies indicate that falling is a leading cause of injury deaths for people 65 and older -- see Falls Among Older Adults: An Overview. More than one third of adults 65 and older fall each year in the United States Twenty percent to 30% of people who fall suffer moderate to severe injuries such as bruises, hip fractures, or head traumas. Men are more likel... Alzheimer's Reading Room, The blogs http://www.medworm.com/rss/comments.php?id=2996010 Sun, 15 Nov 2009 17:37:51 +0100 2996010 http://www.medworm.com/index.php?rid=2561345&cid=t_110560_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2009%2F06%2Fadvertising-works.html On the Maryland Psychiatric Society's listserv I recently heard about a newly available (in the US) SNRI, Savella (milnacipran). It came out for fibromyalgia earlier this year but is used for depression in other countries. First I heard it was available. Who knew?Then, I pick up the June issue of the Psychiatric Times. I usually let this languish in a pile, still wrapped in plastic, for a few months, and then summarily discard it, unread, once it breaks my "3 months rule". (If a throw-away mag/journal is more than 3 months old, toss it.)I flip through it and discover -- only because of the advertisements -- several other new drugs I am unaware of. Where have I been that I've not been clued in? Twitter #fail!So here are the other things. Fanapt (iloperidone) was approved, for treating schiz... Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=2561345 Wed, 01 Jul 2009 03:00:00 +0100 2561345 http://www.medworm.com/index.php?rid=2357407&cid=t_110560_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F04%2F22%2Fpaige-hemmis-blueprint-for-hope-with-depression%2F I just wanted to call out Alicia Sparks’ interview with Paige Hemmis of the TV show, Extreme Makeover: Home Edition, who has come out with her own struggle with depression. I believe that when celebrities talk freely and support educational programs such as this, it helps break down the barriers of stigma and misinformation about serious mental disorders like depression. And it shows folks that no matter how successful you may be, mental illness can strike anyone, at any time. Paige Hemmis is the spokesperson for a campaign called Blueprint For Hope, in an effort to get people talking more about depression (and most importantly, talking to a health care professional if they feel like they may have it). You can take our quick screening quiz for depression if you want to see if it&#82... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2357407 Wed, 22 Apr 2009 15:08:27 +0100 2357407 http://www.medworm.com/index.php?rid=2190557&cid=t_110560_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2009%2F02%2Fssri-horse-race-take-our-meaningless.html This is not science, I'm just playing here, nothing random, nothing controlled, just questions for our readers.I just read Peter Kramer's Psychology Today blog post called Lexapro and Zoloft in a Cloud of Dust. Dr. Kramer talks about the relative efficacy of SSRI's, their market share, and if the drug company's influence docs to prescribe in a way that isn't in sync with research. Lexapro, the most expensive SSRI, apparently has the biggest market with 13% of the market share. He writes:Now comes news of a large-scale analysis of research on antidepressant efficacy. Published in The Lancet, it finds a hierarchy, with Remeron, Zoloft, Effexor, and, yes, Lexapro, leading the pack, Cymbalta and Prozac in the middle, and Luvox, Paxil, and (especially) reboxetine, which is marketed outside the ... Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=2190557 Mon, 16 Feb 2009 15:06:00 +0100 2190557 http://www.medworm.com/index.php?rid=2053203&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F488916084%2F We all need reminders once in a while, but Emory Univeristy psychiatry professor Charles Nemeroff had an unusual way of generating one. On February 9, 2000, he wrote himself an invitation on the letterhead of the Depression and Anxiety journal, which he edited at the time, to write an article to celebrate the 5th anniversary of the introduction of Wyeth’s Effexor antidepressant. For his trouble, Nemeroff offered to pay himself a $3,000 fee, although some handwriting scribbled on the letter indicates Kerry Ressler was later invited to co-author the manuscript and the fee would be split. Moreover, an attached invoice indicates Nemeroff was actually to receive a total of $4,500 - $3,000 for organizing the ‘honorarium’ and $1,500, or half of the fee for the manuscript. Accord... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2053203 Thu, 18 Dec 2008 18:53:42 +0100 2053203 http://www.medworm.com/index.php?rid=1883567&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F421640095%2F The drugmaker has decided against pursuing European approval for its depression pill after consulting with the Committee for Medicinal Products for Human Use, which raised concerns about the med. Earlier this year, you may recall, Wyeth withdrew its application in Europe to have Pristiq approved to treat menopausal hot flashes. Wyeth is counting on Pristiq to help offset impending generic competition to its Effexor blockbuster (Pristiq is actually a version of this drug, by the way). Although already available in the US for treating depression, Wall Street has been skeptical about Wyeth’s ability to distinguish Pristiq from other antidepressants. And the FDA has yet to approve Pristiq to treat hot flashes caused by menopause. Despite the setback, Wyeth execs are not, well, gloomy. &#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1883567 Wed, 15 Oct 2008 14:26:56 +0100 1883567 http://www.medworm.com/index.php?rid=1594001&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F329315688%2F The widely used pills may increase the chance of GI bleeding, but a new study also indicates the risk remains low. The research, which was published in The Archives of General Psychiatry, looked at selective serotonin reuptake inhibitors, or SSRIs, and found bleeding in the upper gastrointestinal tract is more common in people taking the drugs than those who don’t. The study examined 1,321 people treated for upper GI bleeding and about 10,000 people of the same age and sex who did not have such bleeding. The results - 5.3 percent of those with bleeding were taking SSRIs, while 3 percent who didn’t have GI bleeding were taking SSRIs. The risk was even higher in people taking SSRIs and other non-steroidal anti-inflammatory drugs, or NSAIDs. Risk factors include a peptic ulcer or... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1594001 Tue, 08 Jul 2008 01:52:44 +0100 1594001 http://www.medworm.com/index.php?rid=1537900&cid=t_110560_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F06%2F23%2Fwyeths-dr-phil-ninan-on-pristiq%2F Pages: 1 2 Next »     Single Page This is the inaugural entry of a new occasional feature we’ll have here on World of Psychology, On the Couch with Dr. John Grohol. These entries will be interviews with various movers and shakers in the world of psychology, mental and behavioral health, and psychiatry. The schedule is to do at least one a month, so if there’s someone you’d like to see interviewed, please drop us a note! Last Wednesday, I had the chance to sit down and talk to Dr. Phil Ninan, the Vice President of Wyeth’s Medical Affairs, Neuroscience on the telephone about their newest antidepressant medication, Pristiq. Pristiq is a “chemical cousin” of Wyeth’s existing successful antidepressant, Effexor (and its descendants... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1537900 Mon, 23 Jun 2008 18:38:20 +0100 1537900 http://www.medworm.com/index.php?rid=1472695&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F299264877%2F New York psychiatrist Jeff Lieberman has heard J&J’s sales pitch for its new Invega schizophrenia drug, but he’s not too impressed. The problem, he tells Dow Jones, is that Ivega isn’t much different than one of J&J’s best-selling drugs, the antipsychotic Risperdal. In late June, Risperdal is scheduled to lose patent protection, clearing the way for cheaper generics, which could further diminish Invega sales, already characterized as a disappointment by J&J. “I don’t think they have a strong case to make,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school, tells the news service. “It’s basically a me-too drug, and the company hasn’t done the studies that would be required... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1472695 Tue, 27 May 2008 18:43:28 +0100 1472695 http://www.medworm.com/index.php?rid=1451976&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F293437382%2F Last week, the Republicans in Washington rolled out a new slogan which, at first blush, may have sounded clever, because it took a poke at Barack Obama. The slogan? ‘The Change You Deserve.’ Almost immediately, though, the effort was ridiculed. That’s because the slogan has been used by Wyeth to promote its Effexor antidepressant, and it appears to have been trademarked. House Majority Leader Steny Hoyer, a Maryland Democrat, declared that “Democrats, not drugs, is what the American people need.” The slogan, he added, has side effects and “can make you sick. 82 percent of Americans have indicated they are sick and tired of the policies that have been pursued by the Bush-Boehner administration.” House Minority Leader John Boehner, a Louisiana Republ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1451976 Mon, 19 May 2008 12:02:49 +0100 1451976 http://www.medworm.com/index.php?rid=1391296&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275485979%2F Facing a pipeline that can’t compensate for the looming patent expirations of its biggest products, Wyeth hopes to generate revenue with a special introductory offer for it Pristiq antidepressant - when the pill launches next month, the price will be up to 20 percent less than the cost of Wyeth’s existing Effexor antidepressant. Pristiq is, essentially, a revamped version of Effexor XR, a $3.8 billion seller that loses patent protection in 2010, if not sooner. And so Wyeth’s senior vp, Joe Mahady, told analysts that Pristiq will sell for a flat $3.41 per pill for both the mid-range and high-dose versions, according to Dow Jones. By comparison, the 150 mg version of Effexor XR costs $4.19 each, according to drugstore.com. That works out to a 22 percent difference. The site... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391296 Tue, 22 Apr 2008 15:51:28 +0100 1391296 http://www.medworm.com/index.php?rid=1284875&cid=t_110560_151_f&fid=35818&url=http%3A%2F%2Frecoveryissexy.com%2Fare-antidepressants-effective%2F   A recent analysis of studies of the effectiveness of Selective Serotonin Reuptake Inhibitor (SSRI’s) antidepressants found that only people with severe forms of depression show any benefit from the antidepressants studied. It also claimed that, in people with milder depression, the response to the antidepressants was no better than a placebo (i.e. a dummy pill). The drugs studied included Prozac (fluoxetine), Seroxat (marketed as Aropax or paroxetine in Australia), Effexor (venlafaxine) and Serzone (nefazodone, which is no longer prescribed in Australia). The results were published in the US journal Public Library of Science Medicine in an article titled Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data submitted to the Food and Drug Administration. The... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=1284875 Fri, 07 Mar 2008 01:10:15 +0100 1284875 http://www.medworm.com/index.php?rid=1280739&cid=t_110560_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F246138225%2Fnemeroff-confirms-kirsch-ssris-offer.html This post will discuss how the latest meta-analysis claiming to show public health benefits for Effexor actually also showed that antidepressants aren't up to snuff. Part 1 detailed how the study authors found a very small advantage for Effexor over SSRIs, which they then suggested meant that Effexor offered significant benefits for public health over SSRIs. Ghostwriters, company statisticians, questions about transparency, etc. Even the journal editor jumped on board. All the usual goodies.Bad News for SSRIs: But now, on to part deux. Remember that the authors used a Hamilton Depression Rating Scale of 7 or less as indicative of remission, which was the one and only outcome measure of import in their analysis. In their database of studies analyzed in the meta-analysis, there were nine stu... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1280739 Wed, 05 Mar 2008 13:52:00 +0100 1280739 http://www.medworm.com/index.php?rid=1277845&cid=t_110560_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F03%2F04%2Fpristiq-versus-effexor-xr%2F What is Pristiq (desvenlafaxine)? The newest antidepressant approved by the U.S. Food and Drug Administration (FDA), which will hit the U.S. market in a few months. Pristiq is a drug similar in composition to Wyeth’s existing antidepressant, Effexor XR (which loses its patent protection in 2010, 2 years from now). It is Wyeth’s hope that Pristiq, therefore, will replace Effexor XR in a few years’ time. Why? Because Effexor XR makes $3.8 billion (with a ‘b’) a year in sales. Pristiq has shown the same level of effectiveness as many other antidepressants on the market today — about a 2 point difference in a depression rating scale, compared with a placebo. This is the same 2 point difference that research last week showed wasn’t all that clinically ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1277845 Tue, 04 Mar 2008 14:09:33 +0100 1277845 http://www.medworm.com/index.php?rid=1274966&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F245024621%2F There’s nothing like a ringing endorsement for your latest drug or, in the case of Wyeth’s Pristiq, your latest FDA approval. Pristiq, after all, isn’t a new drug - it’s a version of Effexor, the big-selling antidepressant that faces patent expirations. And that’s why Wyeth was so tickled last week to finally win FDA approval after repeated delays. But that doesn’t necessarily mean every psychiatrist or doctor will take a shine to Pristiq. As Michael Liebowitz, the Columbia University psychiatrist who led the major Pristiq trials, tells The Carlat Psychiatry Blog, the pill is no big deal. To wit: Pristiq, he says, “is another SNRI - it is not a revolutionary drug.” It may be more tolerable at the starting 50 mg dose, Liebowitz tells Carlat, but only ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1274966 Mon, 03 Mar 2008 18:52:51 +0100 1274966 http://www.medworm.com/index.php?rid=1274848&cid=t_110560_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F244944962%2Feffexor-beats-ssris-kind-of-sort-of-in.html A recent study in the journal Biological Psychiatry claimed to show that Effexor's (venlafaxine's) alleged advantages over SSRIs "may be of public health relevance." Unstated in the article, but a more accurate reading of their findings, is that antidepressants yield little benefit over a placebo. I'm breaking this into two parts. The current post deals with the authors' claims regarding venlafaxine's superiority over SSRIs. A second post will examine their understated finding that antidepressants are not particularly impressive compared to placebo.The study was a meta-analysis, where data from all clinical trials comparing Effexor to an SSRI were pooled together. The authors used remission on the Hamilton Rating Scale for Depression (HAM-D) as their measure of treatment effectiveness. On ... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1274848 Mon, 03 Mar 2008 16:34:00 +0100 1274848 http://www.medworm.com/index.php?rid=1269674&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F243573409%2F This is a relief for the drugmaker, which faced repeated setbacks in gaining agency approval and needs to replace revenue that will be lost when patents on Effexor XR - a $3.8 billion moneymaker - start to expire this year. Whether Pristiq will prove to be a true lifesaver for Wyeth - let alone depressed patients - is another matter. Pristiq is, essentially, a reworked version of Effexor, which is in a class of antidepressants known as SNRIs. (These work slightly differently than the SSRI class, which includes Paxil, Prozac and Zoloft). For this reason, Wall Street is divided over Pristiq’s ability to generate big dollars. In an investor note this week, Credit Suisse analyst Catherine Arnold, for instance, forecast $480 million in revenue by 2012, while Bear Stearns analyst John Bori... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1269674 Fri, 29 Feb 2008 23:17:59 +0100 1269674 http://www.medworm.com/index.php?rid=1256358&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241209810%2F This study represents a serious challenge to the predominance of pharmacological treatments for depression. Anti-depressants have been shown to help many people, but by no means all. Too many general practitioners are being forced to dish out drugs because they don’t have proper access to psychological therapies services which are recommended by Nice,” the UK regulator. However, Gary Bell, a consultant psychiatrist at Capio Nightingale Hospitals, which provides private psychiatry treatment, contests the conclusions of the Hull research. “Anti-depressants are one of the great breakthroughs in the treatment of depression in last 20 to 30 years,” he tells the paper. “They do not always suit everybody but the results are often life-saving. People who do studies do not have the ha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1256358 Tue, 26 Feb 2008 02:15:03 +0100 1256358 http://www.medworm.com/index.php?rid=1255189&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F240925941%2F Later this week, the agency is expected to decide whether the Wyeth medication should be used to treat depression. Given repeated setbacks the drugmaker has experienced with this drug, however, it remains unclear what the agency will do. One Wall Street analyst, for instance, believes the odds are slightly in Wyeth’s favor, but also issues a whole bunch of caveats. Wyeth, you may recall, has submitted Pristiq for two indications - treating menopausal hot flashes and major depressive disorder. The drug is, essentially, a version of Effexor XR, and Wyeth is hoping Pristiq can makes it way to medicine cabinets because the Effexor patent expires in a couple of years, although one generic drugmaker is already seeking to sell a tablet form. But the agency set aside its application several... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1255189 Mon, 25 Feb 2008 15:16:52 +0100 1255189 http://www.medworm.com/index.php?rid=1208095&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F229782529%2F The Medicines and Healthcare Regulatory Agency upgraded the warnings on all antidepressants - not just SSRIs - after reviewing an FDA analysis of the drugs. As a result, the labeling on these meds should be updated to reflect an increased risk of suicidal thoughts and behavior among young adults and the need to monitor patients closely. The list of drugs that will feature the upgraded warning includes Wellbutrin; Celexa; Paxil; Cymbalta; Lexapro; Prozac; Luvox; Remeron; Serzone, Zoloft and Effexor. “The Pharmacovigilance Working Party considered the review performed by the FDA was of high quality and although it did not provide evidence to suggest that the use of SSRIs and related depressants leads to an increased risk of suicidality in the general adult population, it found a clear ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1208095 Tue, 05 Feb 2008 19:38:46 +0100 1208095 http://www.medworm.com/index.php?rid=1179239&cid=t_110560_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F223180790%2Feffectiveness_of_antidepressants_may_depend_on_genetics.html German researchers have identified genetic variations that predict patient's response to two common antidepressants. Scientist at the Max Planck Institute of Psychiatry in Munich found 11 variants in the gene for a protective transporter protein called P-gp.P-gb which removes drugs and other substances from the brain appears to negatively impact the effectiveness of certain antidepressants. Specifically the study found that citalopram (Celexa) and venlafaxine (Effexor).In the initial part of the study the scientists rendered the genes ineffective for p-gb in mice and gave them the antidepressant. It was found that the concentrations if citalopram and venlafaxine in the brain were controlled by p-gb and that indicated that the antidepressants were substrates of the transporter prot... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1179239 Fri, 25 Jan 2008 20:00:54 +0100 1179239 http://www.medworm.com/index.php?rid=1108700&cid=t_110560_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F203604650%2Fsun_pharm_may_best_wyeth_with.html Wyeth Pharmaceuticals Inc. may have thought that their biggest drug, Effexor XR, was safe from competition for a while but Sun Pharmaceuticals may be cutting into the revenue pie. Wyeth holds the patent on Effexor XR capsules until July 2010 which means no other company can sell a generic version until that time. However, Sun may have found a way around it by producing its generic version of Effexor in tablet form. While both the capsule and tablet have the exact same ingredients, the simple change in pill format should allow Sun to get around patent protection when Wyeth's patent on the drug's main ingredient, venlafazine, expires in June 2008.Wyeth has implied that it expects little impact from the generic pills as they are unlikely to get FDA certification as the exact... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1108700 Thu, 20 Dec 2007 18:00:35 +0100 1108700 http://www.medworm.com/index.php?rid=1107125&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F203403450%2F Bernard Poussot has many challenges as he gets ready to succeed Bob Essner as Wyeth ceo. High on that list is Effexor XR, the big-selling antidepressant. The pill’s exclusivity is being threatened by Sun Pharmaceutical, an Indian generics maker, which is seeking FDA approval to sell a version with the same active ingredient, but with an important difference - in tablet, not capsule form, the Associated Press writes. FDA approval could come as early as June, when patent protection for Effexor’s active ingredient, venlafaxine, runs out, while the patent on the capsule formation doesn’t expire until later. So as the AP points out, Sun’s different formulation should allow it to sidestep Wyeth’s patent rights, and grab up to 15 percent of Effexor XR’s market ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1107125 Thu, 20 Dec 2007 13:20:04 +0100 1107125 http://www.medworm.com/index.php?rid=1096282&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F200357253%2F A few stray items are worth noting, and we do not wish to keep you waiting until later to pass these along… Wyeth was sent a warning letter by the FDA over a “misleading” magazine ad for its Effexor XR depression pill. The agency charges the drugmaker minimized the risks associated with the drug, used inappropriate studies to suggest the pill is more effective than other therapies and falsely inflated the number of Effexor patients to suggest the drug is better and more widely accepted than other meds. This is the warning letter and this is the magazine ad. Amgen hopes osteoporosis meds will relieve its worsening financial pain. At a big cancer meeting in San Antonio, Texas, scientists will introduce the first of a series of pivotal studies of its experimental denosumab d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1096282 Fri, 14 Dec 2007 16:17:07 +0100 1096282 http://www.medworm.com/index.php?rid=1090651&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F199287849%2F There’s good and bad in everything, as they say. On one hand, Wyeth should be upbeat that a low-dose, 50mg version of its Pristiq drug was effective in two late-stage trials for treating depression. On the other hand, the 100mg version, which failed to muster FDA approval earlier this year, wasn’t well tolerated in one of the Phase III studies. You may recall that Pristiq, which is essentially a version of Effexor, is important to Wyeth’s financial fortunes. With the Effexor patent expiring in 2010, Wyeth needs a new big seller. But the drugmaker has been repeatedly frustrated by the FDA, which refused to approve Pristiq for treating depression or menopausal symptoms, partly due to manufacturing problems. The agency asked Wyeth to conduct the low-dose depression studies, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1090651 Wed, 12 Dec 2007 16:59:28 +0100 1090651 http://www.medworm.com/index.php?rid=1060145&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F192602402%2F A few days ago, psychiatrist and industry gadfly Dan Carlat, who publishes a newsletter about drug research and marketing, wrote a first-person essay in The New York Times magazine about being wooed by Wyeth to pitch the Effexor antidepressant to other docs. His escapades in 2002, which earned him $30,000, ended when he had second thoughts about withdrawal symptoms and high blood pressures caused by the med. This mea culpa was widely read, prompting criticism that Carlat was an unethical hypocrite who should return the money. So today, Carlat writes on his own blog that he’s found a way that he hopes will allow him to compensate for taking the “dirty thirty.” We asked him to explain. Pharmalot: Your story generated some heat. Were you were surprised? Carlat: Actually, I e... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1060145 Thu, 29 Nov 2007 23:37:09 +0100 1060145 http://www.medworm.com/index.php?rid=1051231&cid=t_110560_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F190750785%2Feffexor-marketing-and-dr-drug-rep.html Great job by Dr. Daniel Carlat. Read his piece in the New York Times Magazine regarding his stint as Dr. Drug Rep, when he stumped for Wyeth's antidepressant Effexor for a cool $30k in one year. Not bad work if you can get it. It is a fascinating account of a common industry practice -- train doctors to give speeches to other doctors in which certain treatment is pushed hard. Overplay efficacy and downplay negative effects. Drug companies state, with a straight face, that this is "educating" physicians -- buying them fancy dinners and having one of their colleagues read company-produced marketing slides on their product.Carlat's blog is also a great source of information. (Source: Clinical Psychology and Psychiatry: A Closer Look) Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1051231 Mon, 26 Nov 2007 15:10:00 +0100 1051231 http://www.medworm.com/index.php?rid=1048566&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F189815483%2F In a first-person essay in The New York Times magazine, Danny Carlat, a psychiatrist and gadfly who publishes a newsletter about drug research and marketing, recounts how he was wooed by Wyeth to pitch Effexor to other docs. The tale is, basically, one man’s primer on how the process often works - how the reps schmooze, the drugmaker pays and the doc is seduced. For those unfamiliar with the routine, this is worthy reading. For those in the know, this is a reminder of the ceaseless tension between marketing and science. This is how Carlat opens his mea culpa… “On a blustery fall New England day in 2001, a friendly representative from Wyeth Pharmaceuticals came into my office in Newburyport, Mass., and made me an offer I found hard to refuse. He asked me if I’d like to g... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1048566 Sat, 24 Nov 2007 22:36:40 +0100 1048566 http://www.medworm.com/index.php?rid=1025485&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184625269%2F A scheme involving stolen samples used to fill scripts netted millions of dollars for the rep and a drugstore owner. Luther Manning, 52, the Wyeth rep from Union County, NJ, peddled Lipitor and Effexor to pharmacies at cut-rate prices, and William Stracher, 65, of Vermont, who owns Sussman Drugs in Paterson, NJ, sold the drugs and then laundered his profits by buying prized baseball memorabilia, says Bergen County, NJ, prosecutor John Molinelli. “These are men who made millions by duping manufacturers - and, ultimately, the consumer,” he tells The Bergen Record. Authorities have no proof that Stracher and Manning colluded directly, he adds, but the men were arrested separately Tuesday as part of an ongoing probe involving investigators from his office, the FDA and the Departmen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1025485 Wed, 14 Nov 2007 12:07:22 +0100 1025485 http://www.medworm.com/index.php?rid=972758&cid=t_110560_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173969762%2Feffexor_xr.html (extended release) by Wyeth Pharmaceuticals Inc. is the 6th best selling prescription medication in the U.S according to Drug Topics' Top 200 Brand Name Drug by Retail Dollars in 2006.It has been approved to treat major depression, panic disorder, generalized anxiety disorder and social anxiety disorder. Effexor XR is taken once a day and comes in three strength 35.7 mg, 75 mg and 150 mg. Effexor (Venlafaxine) is an antidepressant of the serotonin-norepinephrine reuptake inhibitor (SNRI) class and has been in use since 1993. It works by blocking the transporter "reuptake" proteins for key neurotransmitters affecting mood thus leaving more active neurotransmitters in the synapse. The half-life of venlafaxine is short and patients can experience withdrawal symptoms a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=972758 Tue, 23 Oct 2007 20:15:19 +0100 972758 http://www.medworm.com/index.php?rid=959858&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F171573184%2F Compared with the other big drugmakers reporting earnings this morning, Wyeth offered little spectacular news. But that’s not necessarily such a good thing, either. Earnings inched down about 1 percent - to $1.15 billion, or 84 cents - thanks to costs associated with a plant closing and ongoing cutbacks. And sales of its blockbuster Effexor antidepressant rose only 4 percent. Overall, revenue rose 9.3 percent to $5.62 billion, helped by a 24 percent jump in sales of the Prevnar vaccine and 39 percent gains posted by the Enbrel arthritis treatment. But the real issue facing Wyeth - which recently decided to promote Bernard Poussot to replacing the retiring Bob Essner as ceo - is how to cope with the repeated regulatory failures this year of products that were slated to generate billio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=959858 Thu, 18 Oct 2007 12:16:51 +0100 959858 http://www.medworm.com/index.php?rid=811318&cid=t_110560_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F146208050%2F The drugmaker continues to be a source of speculation, particularly for Credit Suisse analyst Catherine Arnold, who today issued an investor note in which she argues Wyeth is “could be the top major pharma takeout candidate.” She notes that Wyeth shares have plunged 19 percent since the FDA nixed two different product approvals, which she believes spells opportunity. “Wyeth is undervalued even in our worst case scenario…shares offer more than 40 percent upside potential in a takeout scenario,” writes Arnold, noting that patent protection on the Effexor XR antidepressant, a $3.7 billion seller last year, expires in 2011. “Pfizer, in particular, would be a fitting takeover partner.” As she sees it, uncertainty surrounding Wyeth makes it easy to over... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=811318 Mon, 20 Aug 2007 18:33:40 +0100 811318 http://www.medworm.com/index.php?rid=529656&cid=t_110560_109_f&fid=34730&url=http%3A%2F%2Fpsychiatrist-blog.blogspot.com%2F2007%2F04%2Ffda-drugs-february-2007.html 2007: Jan . . . 2006: Dec | Nov | Oct | Sep FDA Drugs: February 2007Warning Letter: Signature Genetics. Seryx is the company that markets an excellent (but expensive) pharmacogenetics program which will take your blood or cheek cells and analyze your DNA for various genotypes which affect how your body metabolizes certain drugs, many of which are psychotropic drugs. This information may be used to help a prescriber make decisions about starting dosages or drugs or combinations of drugs to use or avoid. This topic is a whole 'nother post I could do, but this type of testing can be used inappropriately (2002 Quackwatch page), as well. Anyway, this computer program is considered by the FDA to be a "device", and it has not applied for FDA approval, so the FDA is telling it to stop until approv... Shrink Rap blogs http://www.medworm.com/rss/comments.php?id=529656 Sun, 08 Apr 2007 19:31:00 +0100 529656