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 'atypical'. Sat, 03 Sep 2011 02:10:29 +0100 http://www.medworm.com/index.php?rid=4921735&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fmy-name-is-allen-jones-i-am.html AllenJonesTMAPJanuary20.pdf (application/pdf Object) (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4921735 Sat, 11 Jun 2011 04:29:00 +0100 4921735 http://www.medworm.com/index.php?rid=4911808&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fwhat-word-best-describes-j.html Detestable“Because of the diminished mental capacity of the patients being treated, this court finds the actions of the defendants, upon this (patient population), to be detestable,” (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4911808 Wed, 08 Jun 2011 14:54:00 +0100 4911808 http://www.medworm.com/index.php?rid=4911818&cid=t_120652_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6PnSSHy9aJg%2F In explaining his decision to penalize Johnson & Johnson a healthy $327 million for deceptive marketing of its Risperdal antipsychotic, South Carolina Circuit Court Judge Roger Crouch late last week made a point of reciting a part of the famed credo that is religiously repeated by execs at the health care giant: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must be of high quality.” Why? He wanted to contrast the credo with actions taken by the Johnson & Johnson team. To set the stage for his remarks, Crouch offered this: “It it is the loss of the company’s focus, upon the primary objective of its credo, which bri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911818 Wed, 08 Jun 2011 12:08:23 +0100 4911818 http://www.medworm.com/index.php?rid=4911810&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fprescribed-antipsychotics-aged-3.html Watch the full episode. See more Need To Know.Hat tip: http://seroquellawsuitblog.blogspot.com/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4911810 Tue, 07 Jun 2011 05:21:00 +0100 4911810 http://www.medworm.com/index.php?rid=4893907&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fintroducing-seroquel-lawsuit-blog.html http://seroquellawsuitblog.blogspot.com/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4893907 Thu, 02 Jun 2011 04:02:00 +0100 4893907 http://www.medworm.com/index.php?rid=4876420&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F05%2F28%2Fatypical-antipsychotic-medications-not-a-good-choice-for-alzheimers%2F People with Alzheimer’s disease often suffer not only from the debilitating effects of the disease itself, but also from the secondary psychological effects. Delusions and hallucinations appear in up to 50 percent of those with Alzheimer’s, and as many as 70 percent demonstrate aggressive behaviors and agitation. Both caregivers and family members are distressed by these symptoms, and so everyone is motivated to treat the person with Alzheimer’s with antipsychotic medications. The problem? Antipsychotic medications haven’t always been well-researched on older populations, and fewer still on people with a disease like Alzheimer’s. And when the research has been done, the results are often underwhelming. Take the latest research, for instance, by Vigen and coll... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4876420 Sat, 28 May 2011 19:52:09 +0100 4876420 http://www.medworm.com/index.php?rid=4876513&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F05%2Frisperidone-damned-with-faint-praise.html http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD006918/pdf_fs.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4876513 Sat, 28 May 2011 05:17:00 +0100 4876513 http://www.medworm.com/index.php?rid=4803525&cid=t_120652_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff59stkxE_2w%2F The unnecessary use of antipsychotics in nursing homes has been controversial for several years. Now, a report from the US Department of Health & Human Services Office of Inspector General finds that, in the six-month period from January through June 2007, 51 percent of Medicare claims for atypical antipsychotics were erroneous. This amounted to a $116 million series of mistakes. The OIG report was generated at the request of US Senator Chuck Grassley, who expressed concern that atypical antipsychotics - the newest generation of such meds - were being prescribed on an off-label basis, given that the side effects associated with the drugs include increased risk of death in elderly persons with dementia. Nursing homes are a big business for these drugs. But as the OIG notes, Medicare re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803525 Mon, 09 May 2011 21:25:07 +0100 4803525 http://www.medworm.com/index.php?rid=4759025&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fas-of-31-march-2011-legal-defence-costs.html Source (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4759025 Thu, 28 Apr 2011 08:01:00 +0100 4759025 http://www.medworm.com/index.php?rid=4759031&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fastrazeneca-seroquel-click-to-chat-to.html Click here! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4759031 Wed, 27 Apr 2011 15:23:00 +0100 4759031 http://www.medworm.com/index.php?rid=4464694&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F02%2Fwhat-were-astrazenecas-senior.html Looks like full marks fromDr John Patterson back in 2001But wait! There's more:Martin Nicklasson 2002Nigel Doran 2004Geoff Birkett 2004 (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4464694 Fri, 11 Feb 2011 23:01:00 +0100 4464694 http://www.medworm.com/index.php?rid=4309666&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F01%2F04%2Fwhy-doctors-oversell-benefits-undersell-risks-and-side-effects%2F Virtually across the board of medicine and psychiatry, doctors will constantly and consistently oversell the benefits of a given treatment, and undersell the risks and side effects of it. This may not be as surprising when you look at some of the key factors into how medical and psychiatric treatment is learned and then conducted on patients. Why do doctors often oversell the benefits of a given treatment, and minimize the risks and side effects of it? 1. Treatment is rarely experienced first-hand. While you don’t need to undergo surgery to understand the benefits of surgery or how to do surgery, you will surely have a great appreciation to the patient’s perspective if every surgeon was required to get an appendectomy before being allowed to practice. Surgeons know, in most ca... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4309666 Tue, 04 Jan 2011 20:24:09 +0100 4309666 http://www.medworm.com/index.php?rid=4272591&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F12%2Fazs-brennan-speaks-pass-me-bucket-of.html Bucket storyThe Seroquel storyQuestion 1. How much did Dave Brennan know about "The Seroquel Issue" at the time?http://pharmagossip.blogspot.com/2009/10/astrazeneca-to-pay-520-million-to.htmlThe pharmaceutical company AstraZeneca said Thursday (29/Oct/09) that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.H. Waxman's letter:http://oversight.house.gov/Documents/20070305175741-03469.pdfThe Zoladex issue:http://www.justice.gov/opa/pr/2003/J... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4272591 Sun, 19 Dec 2010 21:14:00 +0100 4272591 http://www.medworm.com/index.php?rid=4139471&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F11%2Fdr-melissa-delbello-speaks-but-this.html Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4139471 Sat, 06 Nov 2010 04:53:00 +0100 4139471 http://www.medworm.com/index.php?rid=3965696&cid=t_120652_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4d1Gfj-MM7I%2F Six months after the FDA determined there is no link between bisphosphonates and thigh-bone fractures, a task force says otherwise. Convened by the American Society of Bone and Mineral Research, the 26-person panel reviewed 310 cases of atypical femur fractures and found that 94 percent, or 291 patients, had taken the drugs, most for more than five years. This is the same task force report the FDA has been waiting to see before issuing recommendations (back story). The panel also found that more than a quarter of patients who experienced atypical femur fractures in one leg experienced a fracture in the other leg as well. On the other hand, the panel pointed out that atypical femur fractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965696 Tue, 14 Sep 2010 12:05:33 +0100 3965696 http://www.medworm.com/index.php?rid=3662919&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F06%2Fstings-in-tail.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3662919 Tue, 15 Jun 2010 05:46:00 +0100 3662919 http://www.medworm.com/index.php?rid=3592367&cid=t_120652_133_f&fid=35129&url=http%3A%2F%2Fwhitterer-autism.blogspot.com%2F2010%2F05%2Fpolishing-our-enunciation.html We bimble gently along in the car on our way home to a chorus of ‘I’m gonna tell it to your face,’ the current mantra, quite brain numbing. My son calls from the back seat,“What’s it mean?”“You tell me, you’ve been singing it for seven minutes now.”“No, the other?”“The other what dear?” “Robert Firmly.”“Do you mean who is Robert Firmly? I don’t think I know anyone by that name. How did you meet him? School?”I notice a great deal of friction coming from behind me as the car vibrates, and commuter traffic fills every inch of the road in all directions.“No. I mean what does it mean, Robber Firmly?”“Robber? Someone’s a thief?”“No.”I ignore the shudders in the car and keep my eye on the police car as it cruises down the hard shoulder with the li... Whitterer on Autism blogs http://www.medworm.com/rss/comments.php?id=3592367 Mon, 24 May 2010 06:53:00 +0100 3592367 http://www.medworm.com/index.php?rid=3534089&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F05%2Futah-goes-for-j-and-astrazeneca.html http://freepdfhosting.com/4223749c08.pdfAs always Ed covers the story well. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3534089 Wed, 05 May 2010 13:03:00 +0100 3534089 http://www.medworm.com/index.php?rid=3524454&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F05%2Fastrazeneca-crestor-diabetes-connection.html The statin drug Crestor, made by AstraZeneca, recently received an expanded label indication from the FDA to include patients with normal cholesterol levels. At the same time, new studies indicate that statins increase the risk of diabetes by 9%. For low-heart-risk patients, the risk-benefit analysis might not support statins. Naveed Sattar, MD PhD, author of the Lancet paper highlighting the diabetes risk, spoke with The HCC. He reviewed his findings and posed some possible biological mechanisms of action to explain how statins could causes diabetes. Other drugs, such as antipsychotics, are well known to cause diabetes. Login to view the story. Register on http://thehcc.tv/ The Healthcare Channel on http://thehcc.tv/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3524454 Sat, 01 May 2010 16:29:00 +0100 3524454 http://www.medworm.com/index.php?rid=3519699&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F04%2Fjay-byrne-v-fluence-and-astrazeneca.html Jay Byrne From SpinProfiles Jump to: navigation, search Jay Byrne is Monsanto's former Director of Public Affairs and former Internet Outreach Programs Director. Prior to Monsanto, Byrne worked for USAID. Since leaving Monsanto, Byrne has become president of Internet PR company V-Fluence[1], whose vice-president, Richard Levine, was formerly part of the Monsanto team for Monsanto's Internet PR firm Bivings Group. V-Fluence is based, like Monsanto, in St. Louis. Monsanto is one of its clients.[2] Covert Monsanto-Bivings campaign Byrne is believed to have been the chief architect of the covert Monsanto-Bivings PR campaign which involved attacks on the company's critics via front e-mails, such as those of Andura Smetacek and Mary Murphy, and material posted on the website of a fa... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3519699 Fri, 30 Apr 2010 06:16:00 +0100 3519699 http://www.medworm.com/index.php?rid=3504954&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F26%2Ftop-25-psychiatric-drugs-in-2009%2F A few years back, we published the Top 20 Psychiatric Prescriptions for 2005. Four years later and we thought it’s about high time we updated that list with the help of the healthcare intelligence firm IMS Health, which tracks prescription data in the U.S. We published the new list this morning, Top 25 Psychiatric Prescriptions for 2009. There’s a few interesting observations we can make based upon this data and the intervening four year span between the two lists. First, anti-anxiety medications like Xanax, Valium and Ativan remain some of the most commonly prescribed psychiatric medications. And it’s no wonder — they are fast-acting and have a short half-life, meaning their effects typically wear off in a few hours. Xanax remains the most commonly prescribed psych... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3504954 Mon, 26 Apr 2010 12:35:14 +0100 3504954 http://www.medworm.com/index.php?rid=3476076&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F04%2Fastrazeneca-seroquel-waynes-world.html Wayne L Pines book - in full!Insider is engrossed! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3476076 Thu, 15 Apr 2010 18:13:00 +0100 3476076 http://www.medworm.com/index.php?rid=3468012&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F04%2Fastrazeneca-seroquel-reinstein-payments.html All 20 pages of them!Back story here. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3468012 Wed, 14 Apr 2010 08:19:00 +0100 3468012 http://www.medworm.com/index.php?rid=3390987&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F03%2Fastrazeneca-seroquel-is-this-canadian.html "Weight change minimal and dose independent (in controlled clinical trials)"Dear oh dear! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3390987 Sun, 21 Mar 2010 22:21:00 +0100 3390987 http://www.medworm.com/index.php?rid=3354569&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F03%2Fj-risperdal-did-j-plan-to-break-rules.html Documents from a lawsuit by the state of Louisiana accusing J&J of off-label marketing shed fresh light on the company's long-standing desire to broaden the market for Risperdal beyond the ailments listed initially on the label—psychotic disorders linked to schizophrenia. J&J disclosed the documents from the suit, filed in the Opelousas district court in September 2004, after Bloomberg News asked the court to unseal them. The case is scheduled to go to trial in September. As early as 1994, the filings show, the FDA ordered J&J's Janssen Pharmaceuticals unit, which developed Risperdal, to stop making false and misleading marketing claims about the drug's superiority to competing medicines. In 1999 the FDA warned J&J in a letter that its marketing materials for geriatric pa... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3354569 Thu, 11 Mar 2010 10:14:00 +0100 3354569 http://www.medworm.com/index.php?rid=3247074&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F02%2Fastrazeneca-seroquel-read-full.html HereListen here (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3247074 Fri, 05 Feb 2010 21:58:00 +0100 3247074 http://www.medworm.com/index.php?rid=3227984&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F02%2Flilly_settles_mississippi_zyprexa_claims_for_185_million.html News is out that Eli Lilly has settled yet another lawsuit with yet another state over claims that the company illegally marketed its antipsychotic Zyprexa for unapproved uses. This time out it's $18.5 million to the State of Mississippi. That brings Lilly's total settlements to date to around $2.8 billion and there's still more to go. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3227984 Mon, 01 Feb 2010 00:00:00 +0100 3227984 http://www.medworm.com/index.php?rid=3223486&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F01%2Fdrug-marketing-is-very-sophisticated.html A FLINDERS University study has exposed "corrupt" drug company marketing practices including covering up adverse side effects and pushing patients on to new, more expensive drugs even when they are less effective. Psychiatrist Peter Parry and American colleague Glen Spielmans studied 400 internal emails and research documents unearthed mainly through court cases. "Drug marketing is a very sophisticated system which corrupts every part of the scientific and medical network," Dr Parry said. Dr Parry said one disturbing finding was that, regardless of the health benefits, drug companies were pushing patients towards their own patented drugs because they could make bigger profits. Such products were called "blockbuster drugs" in the industry because they could make more than $1 billion in p... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3223486 Sat, 30 Jan 2010 02:44:00 +0100 3223486 http://www.medworm.com/index.php?rid=3212594&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F01%2Fbbc-podcasts-file-on-4.html BBC - Podcasts - File on 4 (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3212594 Wed, 27 Jan 2010 03:00:00 +0100 3212594 http://www.medworm.com/index.php?rid=3212596&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F01%2Fastrazeneca-seroquel-listen-to-bbc-file.html HereFile on 4 is on BBC Radio 4 on Tuesday, 26 January , at 2000 GMT, repeated Sunday, 31 January, at 1700 GMT. You can also listen via the BBC iPlayer after broadcast or download thepodcast. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3212596 Tue, 26 Jan 2010 22:19:00 +0100 3212596 http://www.medworm.com/index.php?rid=3208677&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F01%2Fthis-is-must-read-marketing-based.html Contact Glen Spielmans for a copyOr access it hereAbstract: While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-base... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3208677 Tue, 26 Jan 2010 14:04:00 +0100 3208677 http://www.medworm.com/index.php?rid=3208657&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2Fastrazeneca_exec_was_pressed_to_lie_about_seroquel_weight_gain.html Well, this ought to be fun for AstraZeneca to explain in court. The BBC is reporting that a former UK AZ executive was pressed by AZ marketing execs to lie about weight gain issues with Seroquel in the late-1990s. "John Blenkinsop, the company's former UK medical manager, claimed he was pressurised by the company's marketing arm to approve claims about the drug which he felt did not reflect the medical evidence. "'The clinical studies at the time of the launch of Seroquel showed patients developed significant weight gain, significant both statistically and clinically,' he told the BBC's File on 4. "'They [the marketing team] came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain - the data pointed in the opposi... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3208657 Tue, 26 Jan 2010 00:00:00 +0100 3208657 http://www.medworm.com/index.php?rid=3194009&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F01%2Fthis-sounds-interesting-file-on-4.html A British drug company is being sued by more than 15,000 people in the United States who claim its bestselling antipsychotic drug caused severe weight gain, diabetes and other serious medical conditions.Ann Alexander investigates concerns about the way it was marketed and asks how much the public should be told about the drugs they take.File on 4 - SourceHmmm! I wonder which antipsychotic that might be? (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3194009 Thu, 21 Jan 2010 08:25:00 +0100 3194009 http://www.medworm.com/index.php?rid=3176104&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2Freuters_catches_up_with_fs_on_medicating_toddlers.html On Jan. 4, I let you all know about a study just out in the Journal of the American Academy of Child & Adolescent Psychiatry (and it's still not online) concerning the doubling of antipsychotic use in toddlers aged 2 to 5. Well almost two weeks later the Reuters wire service reports on the study and notes that much of the uptick in toddlers is connected so-called child bipolar disorder. "'The psychiatric diagnosis of very young children is anything but an exact science,' said Harry Tracy, a psychologist and publisher of NeuroInvestment, a monthly publication specializing in central nervous system disorders. "'Such disparate causes as ADHD, depression, bipolar disorder, sexual abuse, and family dysfunction can produce very similar symptoms in a toddler.'" You don't say. After banging on ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3176104 Fri, 15 Jan 2010 00:00:00 +0100 3176104 http://www.medworm.com/index.php?rid=3167449&cid=t_120652_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F39bF0JITF2Q%2F The use of atypical antipsychotics to treat elderly patients with dementia appears to have decreased following an advisory issued in 2005 by the FDA concerning the increased risk of death, according to a report in the Archives of Internal Medicine, one of the JAMA/Archives journals. This was an off-label use, by the way. Researchers analyzed nationally representative data to assess rates of atypical antipsychotic drug use between January 2003 and December 2008. From January 2003 to March 2005, the rate of atypical drug mentions increased 34 percent per year, including a 16 percent increase among patients with dementia. In the year before the FDA advisory, approximately 13.6 million atypical antipsychotic mentions occurred, 0.8 million of which involved patients with dementia (here is the a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167449 Tue, 12 Jan 2010 18:28:48 +0100 3167449 http://www.medworm.com/index.php?rid=3167432&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2Fninth_grader_busted_for_seroquel_dealing.html It seems like hardly a week passes when I don't see news of someone getting popped for dealing Seroquel or illegal Seroquel possession. This time out a ninth grader in upstate New York was the alleged dealer: "The boy was caught with the pills after another student was brought to the nurse’s office Thursday morning for a reported drug overdose, sheriff’s officials said Monday. The student, who left his classroom unable to walk straight or speak clearly, told school staff and the school resource officer that he had bought the pill from the ninth-grader, who was selling pills for $1 each. The boy was taken to Mount St. Mary’s Hospital in Lewiston for treatment." The article actually describes Seroquel as an anti-depressant. Sure it is. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3167432 Tue, 12 Jan 2010 00:00:00 +0100 3167432 http://www.medworm.com/index.php?rid=3164024&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2Fbecause_seroquel_can_consume_you.html Yes, those Seroquel for bipolar depression ads--bipolar depression can "consume" you, didn't ya know?--keep airing on TV and are in several major magazines. What's interesting is that the print ads contain five accompanying pages of warnings and precautions attached to use of the drug. Because apparently there's a chance Seroquel can consume you. See BNET for a visual of the print ads. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3164024 Tue, 12 Jan 2010 00:00:00 +0100 3164024 http://www.medworm.com/index.php?rid=3146188&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2F12yearold_busted_for_seroquel_possession.html When a 12-year-old girl in Florida gets busted for possession and intent to distribute Seroquel, then the easy availability of psych meds has gotten way, way out of hand. She reportedly got the drug, along with a painkiller from a 16-year-old. That's out of hand too. The girl was apparently OD'ing at home, her mother figured it out and got her to a hospital. What the hell is happening to this country? (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3146188 Wed, 06 Jan 2010 00:00:00 +0100 3146188 http://www.medworm.com/index.php?rid=3142805&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2010%2F01%2Fpolypharmacy_doubles_in_ten_years.html Conclusions: There has been a recent significant increase in polypharmacy involving antidepressant and antipsychotic medications. While some of these combinations are supported by clinical trials, many are of unproven efficacy. These trends put patients at increased risk of drug-drug interactions with uncertain gains for quality of care and clinical outcomes." Actually, almost all psychotropic polypharmacy is not supported by clinical trials (there are exceptions when it comes to mood stabilizer plus atypical for bipolar disorder, where there are FDA approvals for such combos) and there aren't even many post-marketing meta studies on these kinds of combinations (your Prozac plus Depakote plus Abilify kind of nonsense). So the almost doubling of polypharmacy from the mid-90s to the mid-00s... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3142805 Tue, 05 Jan 2010 00:00:00 +0100 3142805 http://www.medworm.com/index.php?rid=3108534&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fmajor_problems_in_illinois_with_foster_kids_psych_meds.html The Chicago Tribune had a short piece a couple of weeks ago detailing that hundreds of foster kids in the Illinois state system were winding up on psych meds without consent and without approval of the state program. That's apparently an improvement over a few years ago when many more kids were getting them without consent. Even more stunning is that 9 percent of foster kids in Illinois have been diagnosed with bipolar disorder and methinks those can't be all troubled teens (the paper doesn't get at how young some of the kids are). "'This is a really concerning statistic,' said Dr. Michael Naylor, a University of Illinois at Chicago psychiatrist who reviews psychotropic medicine regimens for the state Department of Children and Family Services. Naylor said he worries that drug firms' mark... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3108534 Mon, 21 Dec 2009 00:00:00 +0100 3108534 http://www.medworm.com/index.php?rid=3101048&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fseroquel_for_bipolar_depression_tv_ads_running.html I haven't seen myself yet, since they are reportedly running regionally until the New Year, but I've heard from readers and have read one press account of a wave of TV, print and online ads touting Seroquel, the truly nasty atypical antipsychotic, for bipolar depression. I presume these ads will soon morph into a Seroquel as an add-on depression treatment soon enough. You can get a feel for the ads on the Seroquel website. “Bipolar depression doesn't just affect you--it can consume you,” state the ads. Oh really? That's quite the statement. I'll have more to say about the TV ads when I see one. There was an ad for Seroquel as a bipolar depression treatment on the New York Times main web page last evening. Hopefully, we don't get Quell ads on MySpace and such this time out (yes, AZ was... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3101048 Fri, 18 Dec 2009 00:00:00 +0100 3101048 http://www.medworm.com/index.php?rid=3097039&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fsuspicious_antipsychotics_for_depression_study_comes_into_question.html I was bothered by a study that appeared in the American Journal of Psychiatry back in September which argued that atypical antipsychotics used as add-on treatments to anti-depressants were much more effective than a placebo add-on. The study was by J. Craig Nelson of UCSF and George Papakostas of Harvard/MGH. I was suspicious of the study's findings, which I wrote about in September, since I'm fairly up to speed on the clinical literature and seen only weak effect sizes of atypicals used this way. The reason I am bringing this up is because the great CL Psych has posted something on his blog this week on this study and utterly guts it. (A link to the study is on my original post.) My suspicions then: "Now, here's why you should be very suspicious of the apparent epic victory over placebo... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3097039 Thu, 17 Dec 2009 00:00:00 +0100 3097039 http://www.medworm.com/index.php?rid=3092909&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fantiagitation_drug_submitted_for_fda_approval.html Alexza Pharmaceuticals announced today that it's submitted a new drug application for Staccato loxapine (AZ-004). It's an inhalant designed to be used to address cases of agitation in schizophrenia and bipolar disorder. Much of that agitation is often caused by other active treatments patients may be taking (anti-depressants, anti-seizure drugs, antipsychotics), so it does seem a bit wild that a company has developed a drug to deal with it, but that's the way it goes in the mental health world. Loxapine itself is a typical antipsychotic that is so seldom used that I've never heard of it before now. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3092909 Tue, 15 Dec 2009 00:00:00 +0100 3092909 http://www.medworm.com/index.php?rid=3089534&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Ffda_approves_zyprexa_injectable.html After many attempts and many years, Lilly has gotten the FDA to approve Relprevv, its long-acting Zyprexa injectable, for he treatment of schizophrenia. God help any patient who ends up on it. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3089534 Mon, 14 Dec 2009 00:00:00 +0100 3089534 http://www.medworm.com/index.php?rid=3084965&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fseroquel_ad_on_new_york_times_website.html I am thoroughly discouraged to report that I was just on the the New York Times' website and right there on the main splash page was a flash ad for Seroquel. I've not seen an ad for any psych med on that site before, so I found it startling. The ad read: "My relationships, my family, my work, my life" and then flashed to "Support and resources for living with bipolar depression. Sign up for a patient support program." That program is called "Thinking Forward," "A Program Designed to Help You Keep Moving in the Right Direction." I assume that direction would be taking lots of Seroquel. If you want to sign up for the program and see what kind of garbage AstraZeneca sends your way, go here. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3084965 Sun, 13 Dec 2009 00:00:00 +0100 3084965 http://www.medworm.com/index.php?rid=3079553&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Flilly_new_mexico_settle_zyprexa_case_for_155_million.html Not much to say about this, but New Mexico on Monday settled its claims that Eli Lilly had off-label marketed its antipsychotic Zyprexa for unapproved uses. New Mexico becomes the 39th state to reach some kind of financial settlement with the drugmaker over allegations concerning Zyprexa. Six more states have outstanding cases against Lilly. Lilly's total tab for Zyprexa settlements is now over $2.8 billion, by my estimate. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3079553 Wed, 09 Dec 2009 00:00:00 +0100 3079553 http://www.medworm.com/index.php?rid=3063452&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fantidepressants_antipsychotics_worst_drugs_for_falls_in_elderly.html One of the biggest risks of injury faced by the elderly comes from falls and their attendant broken bones and joints. Of course, researchers have linked anti-depressants to falls by the elderly before and last month the Archives of Internal Medicine had a fascinating meta-study analyzing what classes of drugs commonly given to the elderly created the greatest risks of falls. This is the first time I've seen antipsychotics linked to such falls, not that it surprises me. I'll just list the drug class and odds ratio in order: 1. Anti-Depressants 1.68 2. Antipsychotics 1.59 3. Benzodiazapines 1.57 4. Sedatives 1.47 5. Anti-Hypertensives 1.24 6. NSAIDs 1.21 7. Beta Blockers 1.01 8. Narcotics (presumably painkillers) .96 I think those numbers speak for themselves. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3063452 Mon, 07 Dec 2009 00:00:00 +0100 3063452 http://www.medworm.com/index.php?rid=3059882&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Ffda_reviewers_recommend_review_of_antipsychoticinduced_weight_gain_in_kids.html The FDA has known this is a problem for years but it's only now that FDA reviewers are recommending that the agency formally review its data on antipsychotic-induced weight gain in kids. I assume they felt pushed to do so due to a JAMA study released in late October which outlined explosive weight gain in kids being put on antipsychotics. So now the FDA is going to get into the game. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3059882 Fri, 04 Dec 2009 00:00:00 +0100 3059882 http://www.medworm.com/index.php?rid=3059881&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fzyprexa_gets_fda_approval_for_use_in_adolescents.html Yesterday and today have got to be red-letter days in stupidity at the FDA. Yesterday, the agency approved the antipsychotic Seroquel as an add-on treatment for depression. Today, the agency approved Zyprexa, the controversial diabetes-inducing antipsychotic, for use in adolescents aged 13 to 17 who are diagnosed with schizophrenia or who have manic or mixed episodes of bipolar disorder. Zyprexa has been widely used off-label for these two indications in people younger than 18 for years and with the drug going off-patent in less than 18 months, it's not clear to me what these new indications do for Lilly. I have little else to say. I am so thoroughly disgusted by two days of dubious approvals by the FDA that I want to go sit in a corner and vomit. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3059881 Fri, 04 Dec 2009 00:00:00 +0100 3059881 http://www.medworm.com/index.php?rid=3059880&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Fseroquel_gets_fda_approval_for_use_in_10yearolds.html Yes, the FDA--in addition to giving Seroquel approval for use as an add-on depression treatment in adults--has also approved this nasty drug for use in adolescents aged 13 to 17 and diagnosed with schizophrenia and in kids and teens aged 10 to 17 who are diagnosed with bipolar disorder, a controversial concept in pre-pubertal kids. I simply cannot wait to see whatever promotion AZ does for so-called pediatric bipolar disorder. If you see any ad of any kind for this drug's use in kids and teens, please let me know about it. The fact that the FDA would approve this drug with its many known problems for use in kids calls into question the FDA approval process and also the FDA's commitment to patient safety and scientific evidence. Yet again. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3059880 Fri, 04 Dec 2009 00:00:00 +0100 3059880 http://www.medworm.com/index.php?rid=3056857&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Ffda_approves_seroquel_as_addon_treatment_for_depression.html News broke late last night that AstraZeneca announced that hte FDA has approved Seroquel XR, an atypical antipsychotic, as an add-on treatment for depression. It's been eight months since an FDA panel very gingerly recommended this approval and the agency took an unusually long time to follow through. That should tell you something. The FDA made a bad choice here. Good luck to patients with the weight gain, diabetes, heart problems, muscle tightening, dead in the head feeling and back pain. Can't wait to see if AZ advertises Seroquel on TV. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3056857 Fri, 04 Dec 2009 00:00:00 +0100 3056857 http://www.medworm.com/index.php?rid=3056856&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F12%2Flittleknown_tc5214_touted_as_effective_antidepressant_despite_little_evidence.html Yesterday, AstraZeneca announced it had licensed TC-5214, a compound with alleged anti-depressant qualities, from Targacept. Turns out TC-5214 was developed by researchers at the University of South Florida and today there was an article in the Tampa Tribune on how much money USF might make if the drug pans out. Then a USF official said: "Holbrook compared TC-5214 to the drug Abilify, or aripiprazole, commonly used in treatment of major depression disorder. "'We have a drug here that is two to three times more effective than Abilify without the side effects,' Holbrook said." Abilify is not commonly-used in the treatment of major depression, so that's an error of fact by the reporter. What's more, claiming that the compound is two to three times as effective as Abilify in treating depre... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3056856 Fri, 04 Dec 2009 00:00:00 +0100 3056856 http://www.medworm.com/index.php?rid=3015454&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fgeodon_gets_new_approval.html As an adjunct treatment for bipolar disorder combined with either Depakote or Lithium. No comment. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3015454 Fri, 20 Nov 2009 00:00:00 +0100 3015454 http://www.medworm.com/index.php?rid=3015453&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fabilify_gets_fda_approval_for_autism_irritability.html The FDA today approved the atypical antipsychotic Abilify for the treatment of irritability associated with autism in pediatric patients aged 6 to 17 years old. I'll leave it at that. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3015453 Fri, 20 Nov 2009 00:00:00 +0100 3015453 http://www.medworm.com/index.php?rid=3008381&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fseroquel_lawsuits_back_to_home_courts.html Many of you are aware that there is a complex, class action lawsuit against AstraZeneca in federal district court in Florida. Yesterday, the judge in the case said she'd urge a panel of judges to send 6,000 lawsuits against AZ over various accusations involving Seroquel back to their original state courts. While this will slow down the litigation for plaintiffs, the reality is that this might be good news for injured parties, as the federal court judge was engaging in some wacky rulings and throwing out cases and evidence, according to a participant in the proceedings I've spoken with. We shall see. Overall, AZ faces 14,000 Seroquel-related lawsuits. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=3008381 Thu, 19 Nov 2009 00:00:00 +0100 3008381 http://www.medworm.com/index.php?rid=2999833&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fastrazeneca_whines_about_chicago_tribunes_seroquel_coverage_1.html Yesterday, a letter to the editor appeared in the Chicago Tribune, penned by AZ's chief spokesman Tony Jewell and critical of a recent article in the paper concerning the company's antipsychotic Seroquel. The paper had written about AZ giving $490,000 to a Chicago psychiatrist who prescribed tons of Seroquel, plenty of it off-label, and also authored a study claiming patients lost weight on the drug. In part, it reads (via Soulful Sepulcher): "Since first approved in 1997 for the treatment of schizophrenia, the U.S. Food and Drug Administration has approved Seroquel as safe and effective for three indications in bipolar disorder, as well as in a new formulation for additional treatments in schizophrenia and bipolar disorder. Today Seroquel and Seroquel XR are the only medicines approved a... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2999833 Tue, 17 Nov 2009 00:00:00 +0100 2999833 http://www.medworm.com/index.php?rid=2996011&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fresearchers_ignore_problems_with_meds_in_early_deaths_blame_smoking_no_exercise.html A new study out in General Hospital Psychiatry blames smoking and inactivity for heart disease related deaths among people with schizophrenia and other psychotic disorders. No mention is made of the role of antipsychotics and other medications in this dynamic. From Medicalnewstoday.com: "A large new study confirms that people with severe mental disorders - such as schizophrenia or other psychotic disorders - are 25 percent to 40 percent more prone to die from heart disease than people without mental illness are. "Moreover, smoking and physical inactivity - behaviors that individuals potentially can change - significantly contribute to this increased risk of death, found researchers led by Amy Kilbourne, Ph.D." The study was among people in the VA system. Interestingly, inactivity was a... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2996011 Mon, 16 Nov 2009 00:00:00 +0100 2996011 http://www.medworm.com/index.php?rid=2989385&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fbritish_government_to_limit_antipsychotic_use_for_dementia.html Bloomberg today reports on the British government taking steps to drastically reduce the use of antipsychotics in treating elders with dementia. A recent report estimated that upwards of 1,800 Brits die each year after getting the drugs for dementia and another 1,620 suffer strokes. Keep in mind that all that dementia-Rxing would be off-label bother in the UK and USA. "About 180,000 elderly people with dementia in the U.K. are given the antipsychotic drugs each year, and just 20 percent improve because of the treatment, Banerjee said at a press conference in London. As many as two-thirds of the patients don’t derive any benefit from the pills, which boost the risk of early death and carry a range of side effects including sedation, stiff muscles, and trouble thinking and speaking clearl... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2989385 Thu, 12 Nov 2009 00:00:00 +0100 2989385 http://www.medworm.com/index.php?rid=2985008&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Fpsychiatrist_got_490000_pimping_for_seroquel_engaged_in_wide_offlabel_use.html Back in March, I wrote about a Chicago psychiatrist, Michael Reinstein, who was bugging AstraZeneca for money because he was such a heavy prescriber of Seroquel and who also authored a very dubious study asserting that Seroquel caused patients to lose weight. That's absolutely counter to most studies of the drug and most patient experiences. Anyway, today the Chicago Tribune and ProPublica are out with an article on Reinstein and his AZ connection. AZ gave the doctor $490,000 over 10 years to speak on behalf of the drug, even though the company was internally pooh-poohing his science. One researcher quoted in the article recommends that other studies of Reinstein's should be reviewed by journal editors, given his likely errors in the Seroquel-causes-weight-loss article. The reporters also... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2985008 Wed, 11 Nov 2009 00:00:00 +0100 2985008 http://www.medworm.com/index.php?rid=2985007&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F11%2Futah_settles_zyprexa_claims_for_24_million.html The office of Utah's Attorney General Mark Shurtleff today announced that it had recently settled its illegal off-label marketing of Zyprexa claims with Eli Lilly for $24 million. Said Shurtleff's office in a press release: "It is a crime for pharmaceutical manufacturers to market their drugs for uses that are not approved by the FDA. Zyprexa was only approved for the treatment of schizophrenia and certain types of bipolar disorder in adults, but in 1999, Lilly's long-term care sales force, its marketing branch that focuses on doctors who treat the elderly, began encouraging doctors to prescribe Zyprexa for dementia, Alzheimer's, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. The Attorney General's investigation showed that there we... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2985007 Wed, 11 Nov 2009 00:00:00 +0100 2985007 http://www.medworm.com/index.php?rid=2958931&cid=t_120652_109_f&fid=38950&url=http%3A%2F%2Fwww.shockmd.com%2F2009%2F11%2F04%2Finsomnia-and-depression%2F patients with depression often complain of difficulty getting to sleep, frequent awakenings during the night, early morning awakening, or nonrestorative sleep patients with mood disorders exhibit higher rates of sleep disturbance than the general population, and sleep disturbance can continue even during periods of remission patients with insomnia are up to 10 times more likely to have depression than normal sleepers individuals with persistent insomnia have a significantly higher risk of developing new-onset depression than those who have no sleep complaints 14% of patients with persistent insomnia had concurrent depression whereas depression occurred in less than 1% of patients who had no sleep complaints patients with persistent insomnia had a substantially higher risk of developing a n... Dr Shock MD PhD blogs http://www.medworm.com/rss/comments.php?id=2958931 Wed, 04 Nov 2009 07:41:06 +0100 2958931 http://www.medworm.com/index.php?rid=2944071&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fastrazeneca_to_pay_feds_520_million_to_settle_seroquel_claims.html Just out this morning in AZ's third quarter financial results is this little whopper: "Agreement in principle reached with the US Attorney`s Office in Philadelphia to resolve its investigations related to Seroquel sales and marketing practices. This accounts for $520 million of the $538 million provisions taken in the first nine months, $108 million of which taken in third quarter." I don't have any more details on this yet, so stay tuned. Excepting J&J/Janssen, all the makers of atypicals have agreed to settlements with the feds over illegal marketing. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2944071 Thu, 29 Oct 2009 00:00:00 +0100 2944071 http://www.medworm.com/index.php?rid=2934932&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fjama_study_slaughters_antipsychotics_for_kids_teens_paradigm.html Late yesterday I got a copy of the JAMA study detailing how kids and teens on atypical antipsychotics are putting on lots of weight very quickly and suffering detriments on just about every metabolic measure researchers looked at (my initial post is here). I'll come to the study itself in a moment as well as the accompanying editorial, but first I wanted to note that I have been banging on the kids-on-meds issue (especially atypicals) for three years and have taken a ton of heat in the process. I feel vindicated by this new study and other recent studies tossing cold water on various treatment paradigms involving kids and many of you should feel vindicated as well. I remember how gingerly I first took on the subject in November 2006 and how many of you kicked me in the pants and told me to... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2934932 Wed, 28 Oct 2009 00:00:00 +0100 2934932 http://www.medworm.com/index.php?rid=2934933&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fjama_study_finds_explosive_weight_gain_in_kids_on_antipsychotics.html A study to be published in JAMA tomorrow finds staggering weight gain in kids given antipsychotics. According to the AP: "Children on widely used psychiatric drugs can quickly gain an alarming amount of weight; many pack on nearly 20 pounds and become obese within just 11 weeks, a study found. "'Sometimes this stuff just happens like an explosion. You can actually see them grow between appointments,' said Dr. Christopher Varley, a psychiatrist with Seattle Children's Hospital who called the study 'sobering.' "Weight gain is a known possible side effect of the anti-psychotic drugs which are prescribed for bipolar disorder and schizophrenia, but also increasingly for autism, attention deficit disorders and other behavior problems. The new study in mostly older children and teens suggests ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2934933 Tue, 27 Oct 2009 00:00:00 +0100 2934933 http://www.medworm.com/index.php?rid=2923452&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Flilly_settles_south_carolina_zyprexa_claims_for_45_million.html News is out that the State of South Carolina nad Eli Lilly have reached a $45 million settlement over the state's lawsuit against Lilly over its handling of Zyprexa. "South Carolina and other states argued Eli Lilly: "Did not properly warn of the drug’s side effects, including heart problems, diabetes, hyperglycemia and an increased risk of death in patients with dementia. "Falsely marketed the drug to treat other illnesses, including depression and attention deficit disorder." Oh yes. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2923452 Thu, 22 Oct 2009 23:00:00 +0100 2923452 http://www.medworm.com/index.php?rid=2920468&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fbloomberg_dubs_abilify_a_mood_stabilizer.html In writing up BMS's third-quarter financials yesterday, two reporters at ordinarily-hyper-accurate Bloomberg described BMS's Abilify as a "mood stabilizer" twice in one article. Um, the drug is an antipsychotic and absolutely no one calls it a mood stabilizer, least of all BMS itself. Why Bloomberg is helping them rebrand the drug with a softer image is beyond me. Abilify sales were up 16 percent in the quarter at $653 million in sales. That's a pretty hefty boost. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2920468 Thu, 22 Oct 2009 23:00:00 +0100 2920468 http://www.medworm.com/index.php?rid=2916134&cid=t_120652_101_f&fid=38969&url=http%3A%2F%2Ftheemtspot.com%2F2009%2F10%2F22%2Fatypical-cardiac-chest-pain%2F We taught you what cardiac chest pain looked like, right? You remember. We painted the perfect picture for you in your cardiac emergencies lecture in your EMT class. The pain felt like a pressure. It was brought on by exertion. It radiated to the left arm and through to the back. Sometimes, in your EMT skills stations, we would get fancy and have it begin at rest and radiate to the jaw. Just trying to keep you on your toes after all. All this stuff is good to know. But we may have done you a disservice. You may be walking around with the idea that you can do a quick OPQRST and a SAMPLE and walk away with a fairly good feel for whether or not your patient is having a heart attack. You may be dead wrong. What we may not have told you was that a large percentage of your patients sufferin... The EMT Spot blogs http://www.medworm.com/rss/comments.php?id=2916134 Thu, 22 Oct 2009 12:00:26 +0100 2916134 http://www.medworm.com/index.php?rid=2920471&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fnami_board_member_was_paid_consultant_to_astrazeneca_on_seroquel.html Very big props to Jim Edwards at bnet.com and to whomever handed off some documents to him which reveal that Jim Dailey, then policy director of NAMI Kentucky and a NAMI National Board member, received $600 from AstraZeneca (at the time fighting to get market share for its antipsychotic Seroquel) in return for acting as a consultant for the company for one day in December 2003. You can obtain the document--essentially a contract between AZ and Dailey plus an itinerary of his meeting with AZ--at bnet.com. Also attending the meeting were NAMI National's executive director Michael Fitzpatrick and Chuck Harmon, NAMI's director of corporate relations. To be discussed at the meeting, according to the document, was a presentation by AZ officials of what it saw as the role of advocacy groups in h... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2920471 Wed, 21 Oct 2009 23:00:00 +0100 2920471 http://www.medworm.com/index.php?rid=2916421&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fforest_labs_bullish_on_experimental_antipsychotic.html In an earnings call with investment analysts on Tuesday, Larry Olanoff, Forest Labs' COO, spoke of the company's new atypical antipsychotic Cariprazine, which is currently in phase 2 clinical trials. "Going further back into the question on Cariprazine, I would say that at this present time, we have very positive data in bipolar mania disorder, which potentially as a pivotal trial and clearly is justification going on with Phase III. That indication by itself is probably not commercially feasible, but it’s a nice add-on. "We’re waiting on either the schizophrenia results or if the schizophrenia results are gray and perhaps are not definitive to move on, then we would consider perhaps then waiting for some of the additional trials we have ongoing in both bipolar depression, as well as... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2916421 Wed, 21 Oct 2009 23:00:00 +0100 2916421 http://www.medworm.com/index.php?rid=2890912&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Flilly_settles_zyprexa_claims_with_idaho.html The Idaho State Attorney General Lawrence Wasden yesterday announced that the state and Eli Lilly have reached a settlement of claims the state had made of illegal off-label marketing of Zyprexa by the company. The settlement is for $13 million, which brings Lilly's total payouts for Zyprexa claims to about $2.8 billion. Lilly has now settled claims with almost three dozen states. According to a statement from Wasden's office, Lilly admits no wrongdoing in the settlement. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2890912 Tue, 13 Oct 2009 23:00:00 +0100 2890912 http://www.medworm.com/index.php?rid=2882995&cid=t_120652_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F10%2Fnemeroff-seroquel-and-accme.html Roy Poses has discussed the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance the appearance of efficacy, and suppression of studies with unfavorable results. I call this augmenting the marketed profile of the drug. Daniel Carlat has commented on published Seroquel data here and ClinPsych here.AstraZeneca, the marketer of Seroquel, has also been busy with continuing medical education (CME) programs that augment Seroquel’s profile. Last December 8, one such program went on line, aired by the provider CME Outfitters. The program’s title was “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The corporate logo for CME Outfitters is Education with I... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2882995 Mon, 12 Oct 2009 05:32:00 +0100 2882995 http://www.medworm.com/index.php?rid=2886718&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fnovartis_to_market_fanapt.html Novartis today announced that it's entered into an agreement to market Vanda Pharmaceuticals' recently approved antipsychotic Fanapt. It'll be interesting to see what kind of efficacy and side effect data the company offers to doctors and the public because, to date, I cannot get an answer out of Vanda. The drug is approved for schizophrenia. Novarti is paying Vanda $200 million up front for American and Canadian marketing rights to the drug. In a press release the company noted: "In the 1970s, Novartis pioneered the first atypical antipsychotic medication which was considered a breakthrough for patients with treatment-resistant schizophrenia." That drug was Clozaril and we know how that worked out. In the same press release, the company offers information on Fanapt-associated weight g... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2886718 Sun, 11 Oct 2009 23:00:00 +0100 2886718 http://www.medworm.com/index.php?rid=2876336&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Fastrazeneca_defends_seroquel_weight_gain_warnings.html It's always flattering in a weird way to know that various pharma companies follow this website--AZ, Lilly, BMS, J&J, Wyeth and so on all pop in from time to time--and yesterday I got an email from Tony Jewell, a spokesman for AstraZeneca. He was responding to a post I wrote yesterday regarding AZ casting Seroquel as a "weight neutral" drug in the early years of this decade when the company had knowledge that some patients were packing on the pounds. "Re the post below, it is important to remember that since 1997, when Seroquel was first approved, labeling has alerted physicians that 'diabetes mellitus,' 'hyperglycemia' and 'weight gain' had been observed in clinical trials. We have continued to update the label on these topics as the science has developed." I don't know what the 2001 pa... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2876336 Thu, 08 Oct 2009 23:00:00 +0100 2876336 http://www.medworm.com/index.php?rid=2872007&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F10%2Flilly_settles_zyprexa_claims_with_south_carolina.html Bloomberg is reporting this morning that Eli Lilly has reached a tentative settlement with the State of South Carolina over allegations that the company illegally marketed Zyprexa, the company's atypical antipsychotic, for unapproved uses. The state's lawsuit against Lilly had been set to go to trial this week, but Lilly won a delay and then hammered out an agreement with the state. Financial details of the settlement are not yet available. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2872007 Tue, 06 Oct 2009 23:00:00 +0100 2872007 http://www.medworm.com/index.php?rid=2842773&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Flilly_settles_with_connecticut_for_25_million.html Announced earlier today is a $25 million settlement between Eli Lilly and the State of Connecticut over allegations that the company illegally marketed Zyprexa for unapproved uses including dementia and ADHD. Lilly has already settled about $2.7 billion in other Zyprexa related claims. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2842773 Mon, 28 Sep 2009 23:00:00 +0100 2842773 http://www.medworm.com/index.php?rid=2824405&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Flilly_settles_zyprexa_claims_with_another_7_states.html Bloomberg is reporting that Eli Lilly has settled claims brought against it by seven states concerning the company's marketing of its antipsychotic Zyprexa. Right now, the settlements are confidential (details should come out later), so it's not possible to tell what states are involved or how much money Lilly is paying out. Most of the claims involved illegal off-label marketing of the drug for use in the elderly and children and the bilking of states' Medicaid programs. Lilly told the wire service that it's in "advanced discussions" with the other states. A trial involving claims brought by South Carolina is set to begin in October. Lilly has previously settled various claims brought by individuals, states and the feds for a whopping $2.7 billion. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2824405 Tue, 22 Sep 2009 23:00:00 +0100 2824405 http://www.medworm.com/index.php?rid=2824407&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Fastrazeneca_denied_seroquel_diabetes_link_after_warning_of_it_in_japan.html Bloomberg is reporting today on documents recently unsealed in federal court in Florida in the ongoing case against AstraZeneca concerning claims that the company did not properly notify the public of risks (principally, diabetes and weight gain) associated with its antipsychotic Seroquel, now one of the top selling drugs in the world "Nancy White, the saleswoman, and a colleague met in July 2006 with an unidentified doctor who reported 'getting a lot of flak' from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel 'where causality with the drug could not be ruled out.' "White said in the 2006 note that she told the... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2824407 Mon, 21 Sep 2009 23:00:00 +0100 2824407 http://www.medworm.com/index.php?rid=2786250&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2F60_percent_of_antipsychotic_use_in_va_offlabel.html A new study out in Psychiatric Services asserts that a full 60 percent of antipsychotics prescribed in the VA system in 2007 were being prescribed off-label and, in my opinion, for conditions for which there is little scientific evidence supporting their use. These drugs are known to be dangerous, so you've got to wonder what the hell is going on at the VA and just how much illegal marketing pharma companies have engaged in to create this situation. The study most prominently identifies the off-label use of Seroquel and Risperdal. Here's the stunner to me: "The most common mental illness diagnoses among patients given prescriptions for antipsychotics off label were posttraumatic stress disorder (PTSD, 41.8%), minor depression (39.5%), major depression (23.4%), and anxiety disorder (20.0%... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2786250 Thu, 10 Sep 2009 23:00:00 +0100 2786250 http://www.medworm.com/index.php?rid=2778673&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Fcourt_documents_show_lilly_paid_docs_to_prescribe_zyprexa.html This is maddening: court documents released today show details of so-called call notes made by Lilly sales reps of visits and golf games with doctors in South Carolina, where the company was working hard to get doctors to switch patients to Zyprexa, even for unapproved uses. There were basically payoffs going on, the State of South Carolina alleges in a lawsuit against Lilly, and some of that involved reps making bets with doctors during golf games. One doc agreed that for each time a sales rep made par during one outing that he'd start a new patient on Zyprexa, according to Bloomberg. And then there was this: "Lawyers for the state pointed to a sales note from Sullivan in which he tells another salesman to tie a doctor’s Zyprexa prescriptions to participation in a speakers’ program.... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2778673 Mon, 07 Sep 2009 23:00:00 +0100 2778673 http://www.medworm.com/index.php?rid=2762129&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Fpfizer_settlement_includes_much_offlabel_promotion_of_geodon_and_kickbacks_to_docs_for_zoloft.html The Geodon portion of Pfizer's record $2.3 billion criminal and civil settlement with the Department of Justice yesterday was much larger than I'd thought. What's more, now that details of the settlement are out, it is clear that the company was paying kickbacks to doctors to prescribe Zoloft which is the company's now off-patent anti-depressant. From HHS's press release, the $1 billion combined federal and states civil settlement contains $301,462,065 attributable to illegal off-label promotion of Geodon, the company's weak-selling antipsychotic. The painkiller Bextra made up $502,524,316 of the $1 billion, so it's clear that Geodon was a big piece of the settlement. Specifically, the settlement covers off-label promotion of Geodon for the following unapproved conditions: "Depression,... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2762129 Wed, 02 Sep 2009 23:00:00 +0100 2762129 http://www.medworm.com/index.php?rid=2752130&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F09%2Fpsych_researcher_who_claimed_3yearolds_get_depression_may_have_undisclosed_industry_ties.html A few of you will recall that earlier this month I wrote of a new study in the Archives of General Psychiatry asserting that 3-year-olds can and do suffer from chronic depression, a controversial notion to many people. The published study specifically stated that the lead author, Joan Luby of the Washington University School of Medicine, had no financial conflicts to report. To whit: "Financial Disclosure: None reported. "Funding/Support: Funding for this study was provided by grant MH64769-01 from the National Institute of Mental Health (Dr Luby)." The journal's instructions for authors specifically state: "Authors are expected to provide detailed information about all relevant financial interests and relationships or financial conflicts within the past 5 years." As reported by Ji... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2752130 Mon, 31 Aug 2009 23:00:00 +0100 2752130 http://www.medworm.com/index.php?rid=2741582&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F08%2Fhere_comes_another_new_antipsychotic.html This one is called lurasidone and it's developed by Japan's Dainippon Sumitomo Pharma. The company is so pleased by its phase 3 trials results that it's going to submit it to the FDA early next year for approval as a treatment for schizophrenia. If approved, the drug would be the third new antipsychotic approved by the FDA in about one year's time. Vanda's Fanapt was approved earlier this year although it's not yet on the market and Schering-Plough's Saphris, which was approved earlier this month for use in schizophrenia and bipolar disorder. It'll be interesting to see how all these new drugs work out in a field crowded with second generation antipsychotics, especially with some of those drugs being off-patent (Risperdal) or about to come off-patent (Zyprexa and Seroquel). These new drug... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2741582 Wed, 26 Aug 2009 23:00:00 +0100 2741582 http://www.medworm.com/index.php?rid=2719917&cid=t_120652_133_f&fid=35129&url=http%3A%2F%2Fwhitterer-autism.blogspot.com%2F2009%2F08%2Ftongue-twister.html I make breakfast for the masses and listen to my son chat to his sister. He’s at the age where baby teeth fall like confetti. The tooth fairy has been banned from our house as no-one enjoys night time un-invited prowlers. Currently we enjoy a two-fold extravaganza during all conversations, a backdrop of singing Axel F, the theme song from Beverly Hills Cops, as well as the added bonus of a new form of oral punctuation. Everywhere there is a period, a full stop, my son adds ‘bing, bing, bing.’ As with most new bursts of development, it can be a little disconcerting at first. The theme tune is sung in tune whilst the other person talks, to sort of fill up the empty air space. I don’t really understand how his voice can sing and yet he can also hear what is being said to him at the sa... Whitterer on Autism blogs http://www.medworm.com/rss/comments.php?id=2719917 Fri, 21 Aug 2009 06:53:00 +0100 2719917 http://www.medworm.com/index.php?rid=2719952&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F08%2Flilly_settles_zyprexa_lawsuit_with_state_of_west_virginia.html News is out that Lilly, makers of the antipsychotic Zyprexa, will pay $22.5 million to settle a lawsuit brought by the State of West Virginia which claimed that the company had illegally marketed the drug for unapproved uses including dementia Lilly told Bloomberg: "'We think that putting the issue behind us is not only in the best interest of Lilly but in that of patients, caregivers and health care professionals,' Marni Lemons, a Lilly spokeswoman, said today." Yes, Lilly always has patients' best interests in mind. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2719952 Wed, 19 Aug 2009 23:00:00 +0100 2719952 http://www.medworm.com/index.php?rid=2705313&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F08%2Fstudy_antipsychotics_possible_treatment_for_lung_brain_breast_cancer.html A new study from Australian researchers in the International Journal of Cancer asserts that some antipsychotics can kill lung, breast and brain cancer cells. This was established in in-vitro lab experiments. The big winner among the cancer-killing antipsychotics is reported to be pimozide, otherwise known as Orap, an old first-generation antipsychotic that is among gnarliest in its side effects and is rarely used in treating schizophrenia (I have a friend whose mother has schizophrenia who was rendered catatonic on Orap). In second place was our old pal Zyprexa. From sciencedaily.com: "In the new study, pimozide was the most lethal of six anti-psychotic drugs tested by a team from UNSW and the University of Queensland. Rapidly-dividing cancer cells require cholesterol and lipids to grow ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2705313 Sun, 16 Aug 2009 23:00:00 +0100 2705313 http://www.medworm.com/index.php?rid=2691752&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F08%2Fwhat_happened_to_seroquels_approval_for_depression.html I bring this up because it's been four months since an FDA advisory panel very reluctantly recommended that the FDA proper approve AstraZeneca's atypical antipsychotic Seroquel (in XR form) as an add-on, or adjunctive treatment, for depression. The same panel recommended against FDA approval of the drug for anxiety as well as a maintenance therapy for depression (meaning long-term use) and as a monotherapy for depression (meaning a replacement for SSRIs and SNRIs). The panel found that the drug didn't meet safety and efficacy standards to merit its approval as anything except an add-on therapy. While there's no set schedule for when the agency must accept or reject an advisory panel's findings, the agency generally doesn't wait for four months to make a determination. So something fairly ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2691752 Mon, 10 Aug 2009 23:00:00 +0100 2691752 http://www.medworm.com/index.php?rid=2634648&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Fabilify_sales_way_up_1.html Second quarter financial results are out today for Bristol-Myers Squibb and the results for its atypical antipsychotic Abilify are astounding: worldwide sales of the drug reached $643 million in the quarter, an increase of 22 percent over the previous year. US sales were $518 million, a startling 29 percent increase over the second quarter of 2008. All of which is proof that the company's Abilify as an anti-depesant advertising has paid off handsomely for BMS. As for patients, well that's another story. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2634648 Wed, 22 Jul 2009 23:00:00 +0100 2634648 http://www.medworm.com/index.php?rid=2630353&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Flilly_may_settle_zyprexa_claims_with_more_states.html The Wall Street Journal is reporting today that Eli Lilly is in "advanced discussions" with attorneys general from several states--presumably ones like Utah and Connecticut--who've sued the drug maker, alleging that the company illegally marketed its antipsychotic Zyprexa. There's not much news beyond that. Lilly has already settled about $2.7 billion in claims relating to Zyprexa and pled guilty to a criminal charge in federal court in January. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2630353 Tue, 21 Jul 2009 23:00:00 +0100 2630353 http://www.medworm.com/index.php?rid=2626248&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Fhigh_offlabel_use_of_antipsychotics_for_depression_in_va_system.html CONCLUSION: Antipsychotic medications were commonly used in the treatment of MDD prior to FDA approval, especially in the presence of comorbid mental illness and longer term MDD. Further research is needed to evaluate the long-term safety and efficacy of these medications in combination with antidepressants." Keep in mind this study covered people in the VA system in 2007 and the most widely used antipsychotic for depression within the VA system was Seroquel. But Seroquel isn't approved for treating depression (it is approved for bipolar depression), so this is a very high level of off-label use by the VA and sure makes me curious if there's been any off-label marketing going on by AstraZeneca, which was dinged by the FDA last December for off-label marketing of Seroquel for depression, o... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2626248 Tue, 21 Jul 2009 23:00:00 +0100 2626248 http://www.medworm.com/index.php?rid=2598464&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Fplacebo_outperforms_seroquel_in_teen_bipolar_depression_study.html A study out recently in Bipolar Disorders shows that Seroquel failed to beat, and was in fact beaten by, placebo in treating depression in 32 adolescents aged 12 to 18 and diagnosed with bipolar disorder type 1 who were given Seroquel for eight weeks or were given placebo: "Results: There was no statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint (p = 0.89, effect size =−0.05, 95% confidence interval: −0.77–0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no statistically significant differences in response (placebo =67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates, or change in HAM-A, YMRS, or CGI-BP-S scores (all p > 0.7) betwe... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2598464 Mon, 13 Jul 2009 23:00:00 +0100 2598464 http://www.medworm.com/index.php?rid=2594615&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Ffinnish_researcher_claims_clozaril_safer_than_other_antipsychotics.html A study is just out in The Lancet and it is making an interesting and somewhat bizarre claim: that the atypical antipsychotic Clozaril, long out of favor especially in the US due to safety problems, is in fact safer for people diagnosed with schizophrenia than are perphenazine, Seroquel, Risperdal and Zyprexa. All of these drugs have huge problems and sorting out which is safer is about like asking which brand of handgun kills fewer people. I'm also a bit surprised at how Reuters and Bloomberg have cast their stories on the study, but I'll get to that in a minute. Here's Reuters: "Clozapine was the first of a new generation of schizophrenia drugs, known as atypical antipsychotics. But its use has been restricted by health authorities because of safety concerns and patients taking it requ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2594615 Sun, 12 Jul 2009 23:00:00 +0100 2594615 http://www.medworm.com/index.php?rid=2591687&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Fmom_allegedly_poisons_children_self_with_seroquel.html This is just disgusting: a South Saint Paul, MN woman allegedly used overdoses of the antipsychotic Seroquel to poison her son and a daughter in addition to herself. Mom and the daughter survived, the son died. Now, mom stands accused of murder and attempted murder. It's not clear why the mother had Seroquel in the first place, but it is clear that the widespread use of this drug is bearing some stranger fruit. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2591687 Thu, 09 Jul 2009 23:00:00 +0100 2591687 http://www.medworm.com/index.php?rid=2571181&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F07%2Fantipsychotic_use_up_1000_percent_in_canadian_kids.html This from the CBC: "Medical research out of the University of British Columbia suggests the number of children taking medications known as atypical antipsychotics has increased tenfold over the past decade, CBC News has learned. "The drugs — a class of medicines used to treat psychosis and other mental and emotional conditions — can have potentially serious side-effects, and are linked to increases in stroke and sudden death in adults. "Health Canada has not approved atypical antipsychotics for children." It's all so discouraging that I literally don't know what to say, except to note that it isn't good. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2571181 Thu, 02 Jul 2009 23:00:00 +0100 2571181 http://www.medworm.com/index.php?rid=2570607&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F07%2F02%2Fbreakthrough-for-schizophrenia-and-bipolar%2F Earlier today, we reported that NIMH-funded researchers at three different genetic research institutes from around the world collaborated and published three new studies yesterday in the journal, Nature, that suggested a true breakthrough in our understanding of schizophrenia and bipolar disorder. And to think that just earlier this week, I was dismissing the largely inconclusive findings of genetics research in mental illness. One of the researchers commented on the findings: “There was substantial overlap in the genetic risk for schizophrenia and bipolar disorder that was specific to mental disorders. We saw no association between the suspect gene variants and half a dozen common non-psychiatric disorders.” This is an important discovery — that some of the roots of schi... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2570607 Thu, 02 Jul 2009 19:00:34 +0100 2570607 http://www.medworm.com/index.php?rid=2513093&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Fastrazeneca_cant_exclude_diabetes_expert_witness_from_seroquel_trials.html As I noted yesterday, a few plaintiffs' cases against AstraZeneca over accusations that its antipsychotic Seroquel caused diabetes have been dismissed in Delaware Superior Court recently partly due to a judge's finding that one expert witness could not establish a link between the drug and diabetes. It sure made one wonder where the many thousands of other Seroquel cases were headed. Now a judge in US District Court in Florida, where about 6,000 Seroquel cases currently reside, has ruled that AZ cannot exclude the testimony of a separate plaintiffs expert witness who will argue a link between the drug and diabetes in some patients. Donna Arnett, professor and chairwoman of the epidemiology department at the University of Alabama at Birmingham, argues that Seroquel causes metabolic changes... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2513093 Thu, 18 Jun 2009 23:00:00 +0100 2513093 http://www.medworm.com/index.php?rid=2513095&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Fis_seroquel_litigation_going_down_the_toilet.html Recent reports indicate that several of the initial Seroquel cases brought by plaintiffs against AstraZeneca, the antipsychotic's maker, have been dismissed in Delaware Superior Court. Two were dismissed due to a judge's finding that plaintiffs' expert witness could not tie plaintiffs' diabetes to use of the drug and, in another case, a case was dismissed on the odd grounds that plaintiff hadn't listed possible proceeds from the case on a financial disclosure form. While I'd imagine plaintiffs' attorneys will appeal the dismissals, these cases make it clear just how hard AZ's attorneys are fighting various Seroquel lawsuits. To date, AZ has not settled a single Seroquel related case among the 15,000 or so claims it faces including several brought by various states such as Arkansas over ac... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2513095 Wed, 17 Jun 2009 23:00:00 +0100 2513095 http://www.medworm.com/index.php?rid=2473571&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F06%2F12%2F9-myths-of-bipolar-disorder%2F Bipolar disorder has been the focus of attention in recent years, as a new slew of psychiatric medications have been developed to help treat it. Such medications drive pharmaceutical marketing and increased educational efforts surrounding bipolar disorder (for better or worse). But many myths surround bipolar disorder — what it is, what it means, and how it’s treated. Here’s to busting a few of the most common ones. 1. Bipolar disorder means I’m really “crazy.” While bipolar disorder is a serious mental disorder, it is no more serious than most other mental disorders. Having a mental disorder doesn’t mean you’re “crazy,” it just means you have a concern that is negatively impacting how you live your life. Left unaddressed, this co... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2473571 Fri, 12 Jun 2009 13:11:46 +0100 2473571 http://www.medworm.com/index.php?rid=2474164&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Fperspective_on_antipsychotics_for_kids_fda_panel_recommendation.html Many of you know that an FDA advisory panel yesterday recommended that the agency approve Zyprexa, Seroquel and Geodon--atypical antipsychotics all--for use in teens 13 to 17 with schizophrenia and kids 10 to 17 with alleged pediatric bipolar disorder. I heard from a bunch of readers about how distressed they are over the committee's finding and while there is something disgusting about the idea of these drugs being given to youths, the committee's recommendation, which I expect the FDA to follow, may not actually mean too much in a real world way. That said, there are a couple of things that blow my mind about what's gone on here. I doubt that we're going to see a massive consumer advertising campaign for any of these drugs--schizophrenia is rare and rarer in teens so there's not much of... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2474164 Thu, 11 Jun 2009 04:00:00 +0100 2474164 http://www.medworm.com/index.php?rid=2469926&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Ffda_panel_recommends_approval_of_antipsychotics_for_kids_aged_10_older.html I knew this was going to happen: news is just out that the FDA's psychopharmacology advisory committee today voted to recommend that the FDA approve three atypical antipsychotics for use in treating teens aged 13 to 17 with schizophrenia and in kids aged 10 to 17 for alleged pediatric bipolar disorder. The drugs in question are Zyprexa, Seroquel and Geodon. These drugs have already generated huge problems in adults--diabetes, heart attacks, rapid weight gain--and bear black box warnings about sudden death in elderly patients. Off-label use of these drugs in kids has also lead to the same kinds of problems. Panel members did express concerns about long-term use of the drugs due to their side effects: "'I'm concerned about the lack of true long-term studies' especially in younger patients ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2469926 Wed, 10 Jun 2009 04:00:00 +0100 2469926 http://www.medworm.com/index.php?rid=2464425&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Fseroquel_gives_man_55hour_erection.html So reports the New York Post in an article on a former prison inmate named Dawud Yaduallah who had his daily Seroquel dose upped by 25 percent while in jail in New York State (the article doesn't say why he was taking Seroquel). He soon developed what is described as a painful erection, went to see a jail nurse for help, was ignored (one has to wonder why), and had an erection for a reported 55 hours before being taken to a hospital. Yaduallah, who's out of jail now, has permanent damage to his penis and is suing the nurse for cruel treatment. This side effect of Seroquel was unknown to me--I thought I'd heard them all--and is not listed in the drug's PI, but according to Drugs.com: "Seroquel may rarely cause a prolonged, painful erection. This could happen even when you are not having ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2464425 Tue, 09 Jun 2009 04:00:00 +0100 2464425 http://www.medworm.com/index.php?rid=2463240&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Fseroquel_as_street_drug_flooding_scotland.html Longtime readers know that from time-to-time I've pointed to published articles, academic and journalistic, identifying how widely Seroquel is being used in prisons and elsewhere and that the drug has developed quite the reputation as a street drug, its peaceful, easy feeling when snorted akin to that of heroin. Or so I am told. Now, the UK's Daily Mail reports that Seroquel is flooding the streets of Scotland, in injected and snorted form, and is being used by cocaine addicts to reduce withdrawal symptoms. It goes for a reported 5 Pounds ($10 or so) per pill and I assume that's the 300 mg. size. Quite an interesting drug Seroquel has turned out to be. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2463240 Mon, 08 Jun 2009 04:00:00 +0100 2463240 http://www.medworm.com/index.php?rid=2458495&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F06%2Ffda_dubs_antipsychotics_for_kids_effective_with_substantial_risks.html The FDA psychopharmacology advisory committee next week is slated to meet to evaluate safety and efficacy data for three atypical antipsychotics (Seroquel, Geodon and Zyprexa) for use in 13 to 17 year olds diagnosed with schizophrenia and with 10 to 17 year olds diagnosed with so-called pediatric bipolar disorder. The committee will then vote on what recommendations to make to the full agency on these drugs which have proven extremely problematic in adults Today the FDA itself released its briefing package for committee members (note: the packages are huge and not recommended for download unless you have a technical need for them) and in his introduction FDA psychiatry products chief Thomas Laughren put it like this: "Although the Division has not yet reached a final conclusion for these... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2458495 Fri, 05 Jun 2009 04:00:00 +0100 2458495 http://www.medworm.com/index.php?rid=2442695&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fstudy_lilly_marketed_zyprexa_offlabel_for_bipolar_disorder.html A new study is out in the journal Social Science & Medicine examining how Eli Lilly marketed Zyprexa, its controversial atypical antipsychotic, in primary care settings (meaning to non-psychiatrists). The paper's author, a psychology prof at Metropolitan State University in Minnesota named Glen Spielmans, relied heavily upon the Zyprexa documents hosted on this site for his trail of evidence. As far as I know, his paper is the first published academic study of how Lilly marketed the drug far outside of its approved indications (schizophrenia and mania) in the first half of this decade. Longtime readers will remember that I first wrote about Lilly's marketing of Zyprexa for bipolar disorder type 2, for which it did not have marketing approval, and for agitation and mild depression, for wh... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2442695 Fri, 29 May 2009 04:00:00 +0100 2442695 http://www.medworm.com/index.php?rid=2442693&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fholland_refuses_to_approve_seroquel_for_depression.html According to Reuters, the Netherlands Health Authority, acting as a reference body for the European Union, shot down AstraZeneca's application to have Seroquel approved as a treatment for depression. "The Dutch decision to refuse approval for the medicine in MDD, because of a negative benefit-to-risk balance, comes after Seroquel XR won partial support from U.S. advisers as a treatment for the same condition last month." AstraZeneca has submitted its application to the European Medicines Agency. The drug was reportedly approved for depression in Canada last month (news to me). (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2442693 Fri, 29 May 2009 04:00:00 +0100 2442693 http://www.medworm.com/index.php?rid=2442700&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fseroquel_documents_criminals_led_seroquel_clinical_trials.html I'm sure most of you are at least vaguely aware of the case of Richard Borison and Bruce Diamond, a psychiatrist and a researcher at the Medical College of Georgia who were found guilty of ripping off the college to the tune of $10 million in the 1990s, running some bogus research trials and, in Borison's case, was eventually sentenced to prison. Borison did 10 years before being released on probation in 2008. Diamond was ordered to pay $150,000 in fines, $50,000 in receivership expenses, and $1.1 million dollars in restitution and forfeitures. The pair also used VA facilities in conjunction with their MCG research. One of the beauties coming out of the newly-released Seroquel documents is evidence that the pair were also deeply involved in running clinical trials of the drug for AstraZen... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2442700 Wed, 27 May 2009 04:00:00 +0100 2442700 http://www.medworm.com/index.php?rid=2442705&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fseroquel_documents_glucose_dysregulation_in_kids.html Next month, the FDA's psychopharmacology advisory committee takes up AstraZeneca's application to have its atypical antipsychotic Seroquel approved for the treatment of schizophrenia in kids aged 13 to 17 and for use in so-called pediatric bipolar disorder in kids aged 10 to 17. Seroquel is not currently approved for use in pediatric populations for any indication. The committee will make a recommendation to the FDA on whether to approve or not approve the drug for these disorders, but the agency is not bound by its recommendation. AZ's submission to the FDA has not been made public yet, so it's not clear what kind of safety and efficacy data the committee will see, but from the recently-released Seroquel documents (all lawsuit-related) it is clear that the drug caused multiple cases of g... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2442705 Tue, 26 May 2009 04:00:00 +0100 2442705 http://www.medworm.com/index.php?rid=2442702&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fcbs_news_goes_after_risperdal_causing_boys_to_grow_breasts.html I suspect many of you remember--because how could you forget?--that last year I noted reports that Risperdal, a widely-used atypical antipsychotic, was causing teen boys to grow breasts due to the drug's propensity to boost prolactin levels and cause gynecomcastia. Now CBS News has caught onto this and last night had a piece on one of the boys. Sadly, the boy in question thought he was a girl, according to his mom, and still thinks he's a girl at 19-years-old, despite a double mastectomy. He was given the drug for ADHD. The piece also notes that a boy who was 4-years-old developed breasts from using the drug. Of course, the drugmaker Janssen told CBS that it had done nothing wrong and had adequately warned of gynecomastia in the drug's labeling. I'm sure they'll have much success making ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2442702 Tue, 26 May 2009 04:00:00 +0100 2442702 http://www.medworm.com/index.php?rid=2424476&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fseroquel_documents_allegations_az_planned_offlabel_marketing_to_kids_elderly_tried_obscuring_weight.html Another batch of Seroquel documents is being released this morning by plaintiffs attorneys for people suing AstraZeneca over allegations involving its atypical antipsychotic. I'll get them myself this morning and get online what makes sense as soon as I can. Meanwhile, the Wall Street Journal and AP got a sneak peek yesterday and picked off different pieces of the documents. The WSJ reports that: "The documents cited plans to 'broaden Seroquel use on and off-label,' including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups. "Tony Jewell, a spokesman for AstraZeneca, denied that the company sought to encourage off-label uses of the drug. 'These documents do not advocate the inappropriate promoti... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2424476 Wed, 20 May 2009 04:00:00 +0100 2424476 http://www.medworm.com/index.php?rid=2424474&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fseroquel_documents_az_planned_offlabel_seroquel_sales_in_2000.html Amidst the just-released batch of Seroquel documents is one dated Dec. 18, 2000, headlined "'Seroquel' Strategy Summary." In it, AstraZeneca executives laid out what they considered key success factors for the drug, which was only approved for schizophrenia at the time and sales of which were far outpaced by J&J's Risperdal and Eli Lilly's Zyprexa. The document clearly states that one of the key success factors to increasing sales was to "broaden Seroquel use on and off label" and to "utilise whole selling team, educational programmes to share off label data." The spellings are as in the document. Ed Blizzard, a plaintiffs' attorney in the various Seroquel lawsuits now underway, said in an interview that this document was approved at the very top of the company and is evidence that the c... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2424474 Wed, 20 May 2009 04:00:00 +0100 2424474 http://www.medworm.com/index.php?rid=2424473&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fseroquel_documents_astrazeneca_exec_admits_fuckups_in_seroquel_study_published_article.html Many of you remember that in February I broke the story that Wayne Macfadden, a psychiatrist and StraZeneca's US medical officer on Seroquel and the head of CNS research at AZ, had a string of sexual affairs with women intimately involved in outside academic research of the drug as well as with writing up medical studies of the drug that were the basis for its approval for bipolar depression in 2006. My earlier reporting was based upon a filing in the case. Now, the full set of Macfadden's sexy emails with a researcher at the Institute of Psychiatry in London, England and with a ghostwriter at Paraxel MMS in the US have been released. I'm making them public because they show how deeply conflicted the relationships between Macfadden and these women were and because the editors of the Ameri... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2424473 Wed, 20 May 2009 04:00:00 +0100 2424473 http://www.medworm.com/index.php?rid=2417150&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fexabilify_spokespatient_unfairly_criticized.html There's been a lot of criticism of ex-Abilify spokespatient/"Electroboy" author Andy Behrman in the wake of last week's front page Wall Street Journal article about his split with Bristol-Myers Squibb. The company had paid him a reported $400,000 to speak on behalf of the drug while, at the same time, Behrman was experiencing some wicked side effects from the drug in 2004 and 2005. While I understand some of the criticism, I'm afraid that a post at Bnet.com yesterday by Jim Edwards, who's usually pretty reasonable in his judgments, is so full of excessive judgments that I'm going to call him on them. It appears that Edwards freaked out over a mass email Behrman sent out last week, one I received as well: "Behrman sent a rambling email from his Blackberry to his 'friends' and '3,000+ ment... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2417150 Tue, 19 May 2009 04:00:00 +0100 2417150 http://www.medworm.com/index.php?rid=2415781&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fantipsychotic_use_in_kids_slows_in_2008.html The Wall Street Journal is out with a good piece today revealing that antipsychotic use among kids is still going up but that the rate of increase slowed somewhat last year. The paper attributes this to increased attention to the side effects of these drugs, particularly in light of various lawsuits over illegal marketing of atypicals and the cautionary tale of the Rebecca Riley saga. But these drugs are still being used far too widely (and wildly) in my opinion. Use of atypcials among kids aged 18 and younger increased by 5.3 percent in 2008, compared with an 8.7 percent increase the prior year. Some startling stats from the article: 25 percent of Risperdal's sales came from kids and most of that would've been off-label (the drug is now generic); and, sales of atypicals among kids accou... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2415781 Mon, 18 May 2009 04:00:00 +0100 2415781 http://www.medworm.com/index.php?rid=2415780&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Ffda_approves_risperdal_injectable_for_bipolar_disorder.html Not a lot to say about this: the FDA today approved Risperdal CONSTA, the long-acting injectable antipsychotic, for use as a maintenance treatment in bipolar disorder and as an add-on treatment to Lithium and Depakote. Let's hope very few people wind up having to take/being forced to take this drug. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2415780 Mon, 18 May 2009 04:00:00 +0100 2415780 http://www.medworm.com/index.php?rid=2406128&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fexabilify_spokespatient_slams_abilify_side_effects_on_youtube.html A good number of you are aware that Andy Behrman, author of "Electroboy," was a spokespatient for Bristol-Myers Squibb's Abilify for a time and, according to yesterday's Wall Street Journal piece on him and his broken relationship with BMS, he made upwards of $400,000 speaking on behalf of the drug. Ironically, Behrman was suffering severe side effects from the drug during much of that period. Now, Behrman has recorded a video where he uses the side effects voiceover from some of the drug's TV ads and notes that he suffered many of the identified side effects. Then he adds a zinger, playing off the Abilify ads' "Ask your doctor if Abilify is right for you." I pass this along to you for what it's worth to you. BTW, I know several readers were deeply critical of Behrman for speaking on b... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2406128 Fri, 15 May 2009 04:00:00 +0100 2406128 http://www.medworm.com/index.php?rid=2406131&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fformer_abilify_spokespatient_criticizes_abilify_featured_in_wall_street_journal.html Regular readers are well aware of the tale of Andy Behrman, author of "Electroboy," who became a spokespatient in 2004 and 2005 for Bristol-Myers Squibb's atypical antipsyhcotic Abilify. But by 2006, he'd experienced such nasty side effects on the drug--jerking legs among them--that he went off it and eventually wrote a piece for my site in 2006 concerning his experiences with Abilify (a piece that had originally been published by About.com but was soon removed by the company). As I noted last year, Behrman was on the verge of authoring a tell-all book about his experiences shilling for Abilify before BMS sales reps, doctors, nurses and even patients. BMS had nothing to say about Behrman when I queried the company last year, but it has plenty to say now as Behrman and BMS are in a war of w... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2406131 Thu, 14 May 2009 04:00:00 +0100 2406131 http://www.medworm.com/index.php?rid=2406134&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Flilly_wins_a_zyprexa_court_ruling.html This has to be the first positive ruling for Eli Lilly in Zyprexa litigation in ages. From Bloomberg: "U.S. District Court Judge Jack B. Weinstein in Brooklyn, New York, said he will exclude the expert testimony of Dr. Stephen Hamburger. The doctor has offered testimony in some 20 individual Zyprexa cases, seven of which now have pending summary judgment motions before Weinstein, the judge said in a decision issued yesterday. "Hamburger was 'shockingly careless about the facts in the cases he proposes to opine about,' Weinstein said. The doctor gave conflicting answers to questions about the 'claimed causal link between Zyprexa intake and medical injury,' he said. "'Faced under oath with consistent extensive factual discrepancies in his analysis, he merely shrugged them off or flippantl... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2406134 Wed, 13 May 2009 04:00:00 +0100 2406134 http://www.medworm.com/index.php?rid=2406137&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fstudy_tries_to_obscure_abilifys_akathisia_problems.html CL Psych had a wonderful post the other day harping on Abilify's propensity to cause akathisia in some patients taking it for depression and other disorders. What CL Psych did was uncover a recent study in the Journal of Clinical which purported to examine akathisia rates in second generation antipsychotics. Akathisia is a well-kwown clinical outcome in antipsychotics old and new and seems to be especially prevalent with Abilify. One of the drug's clinical approval trials for its FDA approval as an add-on treatment for depression showed akathisia rates at 26 percent for people taking Abilify but only 4 percent for those taking a placebo. But in the JCP study none of that was mentioned. Hm, I wonder why. "So Abilify causes less akathisia than older medications and it's unclear if it cause... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2406137 Tue, 12 May 2009 04:00:00 +0100 2406137 http://www.medworm.com/index.php?rid=2406135&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fflorida_probes_doctor_of_7yearold_suicide.html Many of you are already aware of the awful case of a 7-year-old boy in Florida named Gabriel Myers who last month hanged himself in the shower of his foster home. The kid was chock-full of psych meds--Symbyax, Vyvanase and had recently been on Lexapro. Now a Florida state senator is calling on the State of Florida to investigate the prescribing psychiatrist both to determine what happened and, from a medical board angle, to determine if there were any violations of sound medical practices. Already the State's Department of Children and Families has convened a working group to look into the agency's use of psych meds. Over the last year or so, Florida has had in place a special monitoring program to catch potential overuse of psych meds in kids. The Miami Herald reports: "Dr. Sohail Punj... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2406135 Tue, 12 May 2009 04:00:00 +0100 2406135 http://www.medworm.com/index.php?rid=2399200&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Fleading_psychiatrist_amazed_by_fanapt_approval.html There's still quite a bit of attention being paid to Wednesday's surprise FDA approval of Vanda Pharmaceuticals' atypical antipsychotic Fanapt for use in schizophrenia. Surprised was Columbia University psychiatrist Jeff Lieberman, who told Forbes.com: "Lieberman says he is 'amazed' the FDA approved the drug. He says the approval is 'probably a testament to persistence' on Vanda's part. 'There's no harm in having it,' he says. 'It gives clinicians another option to choose from, but it doesn't really add anything in terms of any substantial advance in efficacy or safety.'" As far as I know none of the approval studies have been published yet, so it's tough to know what the drug's safety and efficacy might be. Like almost everyone who follows these issues, I was stunned that the FDA approv... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2399200 Fri, 08 May 2009 04:00:00 +0100 2399200 http://www.medworm.com/index.php?rid=2398818&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F07%2Fsurprise-approval-of-fanapt-makes-stock-go-wild%2F Shares of Vanda Pharmaceuticals, the makers of Fanapt (iloperidone), surged today after the U.S. Food and Drug Administration sprang a surprise drug approval for Fanapt for schizophrenia late yesterday. In afternoon trading today, the stock hit $10.00 a share, over 8 times what the stock was trading just a day earlier. It fell back to trading around $7.54 - $7.95 range at this time. The drug has a better safety profile in clinical trials than other atypical antipsychotics, which some analysts believe will help boost prescriptions when it goes on the market this summer. Of course, the safety profile may be overly optimistic, as it was for other atypical antipsychotics before they hit the market and reality set in (e.g., use on a more diverse population). Certainly the company could’ve... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2398818 Thu, 07 May 2009 19:58:34 +0100 2398818 http://www.medworm.com/index.php?rid=2390374&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Ffda_advisory_panel_to_consider_seroquel_zyprexa_and_geodon_for_kids_teens.html Although it's been known for a few weeks that the FDA's psychopharmacology advisory committee would meet in early June to make recommendations to the FDA proper regarding approval of Seroquel, an atypical antipsychotic, for use in children and teens aged 13 to 17 with schizophrenia and those aged 10 to 17 with pediatric bipolar disorder, it wasn't clear if other drugs would be considered at the same time. Yesterday, news came out of the FDA that Zyprexa and Geodon were coming along for the ride as well. Pfizer is asking the FDA to approve Geodon for the "acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in patients 10 to 17 years old." Lilly is seeking FDA approval of Zyprexa for the "acute treatment of manic or mixed episodes a... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2390374 Thu, 07 May 2009 04:00:00 +0100 2390374 http://www.medworm.com/index.php?rid=2390373&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F05%2Ffda_approves_new_antipsychotic_for_schizophrenia.html The FDA yesterday approved Fanapt (iloperidone), an atypical antipsychotic made by Vanda Pharmaceuticals, for use in the treatment of schizophrenia in adults. I don't know a lot about this drug--it's the first antipsychotic given its initial FDA approval in years--but what I do know gives me cause for concern. First, last year the FDA issued a not approvable letter for the drug, so there was clearly something wrong about the safety and efficacy of Fanapt at that time. What exactly we're unlikely to know, since the FDA won't release non-approvalable letters and there's little chance of the company doing so. What changed between then and now with the drug and its performance I cannot say. Second, I strongly suspect that the drug will quickly be repurposed for use in other disorders, possib... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2390373 Thu, 07 May 2009 04:00:00 +0100 2390373 http://www.medworm.com/index.php?rid=2389934&cid=t_120652_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F05%2Fmore-drugs-prescribed-but-seniors-prescriptions-double%2F News out today shows that psychiatric prescriptions have risen 73 percent in adults and 50 percent for children in the 1996 to 2006 time period. Seniors’ prescriptions for medications such as antidepressants and atypical antipsychotics during the same time period doubled (something that USA Today strangely terms as a “spike,” despite it occurring over a decade). The problem with this data is that we really don’t have much to compare it to. Is a 7 percent annual increase in psychiatric prescriptions over a 10 year time period indicative of over-prescribing and effective pharmaceutical marketing? Or would we expect a similar increase no matter what? (Sadly, no researchers track “prescriptions” of psychotherapy, so we don’t even have other treatment m... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2389934 Tue, 05 May 2009 14:24:03 +0100 2389934 http://www.medworm.com/index.php?rid=2387228&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F05%2Fhow-many-seroquel-lawsuits-will-there.html Jim Edwards is keeping a running total. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2387228 Mon, 04 May 2009 08:11:00 +0100 2387228 http://www.medworm.com/index.php?rid=2381131&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Flilly_settles_georgia_zyprexa_claims.html The State of Georgia yesterday settled its claims against Eli Lilly over accusations of off-label marketing of its antipsychotic Zyprexa for $15 million, according to the Atlanta Journal_Constitution. The feds will get $9 million of that to cover payouts from the federal portion of Medicaid while the state will get $6 million. (Neither Lilly of the Georgia AG's office have put out press releases.) The AJC's reporter pointedly quotes trial lawyers who say that the state let Lilly off cheap. Keep in mind that last year the much smaller State of Alaska settled similar claims with Lilly for $15 million. It's especially surprising since Lilly has pleaded guilty to federal criminal charges concerning its marketing of Zyprexa. You'd think taking this case to a jury in Georgia would pretty much b... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2381131 Thu, 30 Apr 2009 04:00:00 +0100 2381131 http://www.medworm.com/index.php?rid=2376801&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2F10_percent_of_depressed_patients_now_take_antipsychotics_1.html A recent conference call with financial analysts by executives with Bristol-Myers Squibb, makers of Abilify--the antipsychotic that will cure your non-psychotic issues--is revealing. Over 10 percent of Americans now take an atypical antipsychotic for depression, according to the company. Much of that prescribing has got to be off-label as Abilify is the only approved antipsychotic for the condition, all of which makes me damn suspicious of how Seroquel's bipolar depression approval in 2006 may have been turned into a proxy approval for major depression. Forget about Prozac Nation, this is Atypical Nation. Think I'm joking? Antipsychotics are now the top revenue producing class of drugs, topping even statins. But I'll let Elliott Siga, BMS's chief scientific office, talk his talk: "Obvio... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2376801 Wed, 29 Apr 2009 04:00:00 +0100 2376801 http://www.medworm.com/index.php?rid=2376826&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F04%2Fwe-have-optimism-based-i-think-on.html Among all patients taking the new generation of antipsychotic medication, children are most likely to suffer severe weight gain and metabolic disturbances.But the use of these drugs to treat children has seen steep growth. Between 1990 and 2000, prescriptions for children and adolescents grew 160 percent, according to a 2005 study; other studies show they continued to grow briskly through the early 2000s.Virtually all of that prescribing has been off-label. Among the atypical antipsychotics, only risperidone (marketed as Risperdal) has been approved by the Food and Drug Administration for use by children with schizophrenia. In June, the FDA will consider a petition by AstraZeneca for permission to promote the use of Seroquel by adolescents (ages 13 to 17) with schizophrenia and by younger ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2376826 Tue, 28 Apr 2009 23:29:00 +0100 2376826 http://www.medworm.com/index.php?rid=2368702&cid=t_120652_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F04%2Fi-kid-you-not.html StoryHat tip: Furious Seasons (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2368702 Sat, 25 Apr 2009 14:11:00 +0100 2368702 http://www.medworm.com/index.php?rid=2365431&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fpennsylvania_drug_sweep_nets_alleged_seroquel_dealers.html There was a big drug sweep of low level dealers in Lehigh County, Pennsylvania yesterday and along with popping people for allegedly dealing cocaine and pot, cops arrested two people for allegedly dealing Seroquel: "Ashley Thomas Morgan, 21, with no known address, was charged with criminal use of a communication facility, sale of non-proprietary drug, possession with intent to deliver a controlled substance, possession of a controlled substance and two counts of criminal conspiracy. He was sent to county prison under $50,000 bail. "He and another person allegedly twice sold Seroquel, a medication normally used to treat bipolar disorder and schizophrenia, to an undercover officer in February at Route 873 and Chestnut Street in Slatington. He and the other person also allegedly sold cocain... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2365431 Fri, 24 Apr 2009 04:00:00 +0100 2365431 http://www.medworm.com/index.php?rid=2365430&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fseroquel_being_trialed_for_anorexia.html I hadn't known AstraZeneca was trialing its top-selling atypical antipsychotic Seroquel as a treatment for anorexia nervosa, but in fact it has two trials underway. A press account of the trial reveals that one patient's "weight is back in a healthy, normal range and her thoughts about food have improved." That's nice, although it's a bit odd to be publicizing a clinical trial before it's complete. It'll be interesting to see if AZ pursues FDA approval of the drug for anorexia. A small study last year found that Lilly's atypical Zyprexa was an awesome anorexia treatment. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2365430 Fri, 24 Apr 2009 04:00:00 +0100 2365430 http://www.medworm.com/index.php?rid=2365433&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fpsych_med_polypharmacy_incapacitates_elderly_man.html There's apparently a real trend in our land toward excessive polypharmacy in our elders and this account from Peter Gott's "Family Doctor" syndicated column provides a spooky example of the trend and the overuse of psych meds to "calm" patients. The man was 79 and was diagnosed with multisystem atrophy and also has dementia. "He fell last May, breaking his arm and hitting his head. Within one day, he was unable to feed himself, walk or do anything. He was hospitalized for eight days and then spent two months in a rehabilitation facility. During his hospitalization, he became extremely agitated and was given Ativan. A few days later, it was found that he had a urinary-tract infection. He had two more UTIs while in rehab, which would cause him to become agitated. Each time, he was given Ati... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2365433 Thu, 23 Apr 2009 04:00:00 +0100 2365433 http://www.medworm.com/index.php?rid=2354094&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fatypical_antipsychotics_causing_akathisia.html Conclusions: Akathisia remains a concern with the use of SGAs. More accurate and standardized evaluations are required for a better understanding of the nature and incidence of akathisia." I've not seen the full study yet, so I cannot speak to the prevalence of akathisia in the underlying studies, but it sure doesn't sound good, especially when added to all the other known problems with these drugs. Keep in mind that the clinical trials of Abilify as an add-on treatment for depression showed akathisia cropping up in 26 percent of patients (versus 4 percent on placebo). If that doesn't make doctors and patients worry about this class of drug, then very little will. (Source: Furious Seasons) Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2354094 Wed, 22 Apr 2009 04:00:00 +0100 2354094 http://www.medworm.com/index.php?rid=2349708&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fmarketing_drives_people_to_antipsychotics_for_depression.html I'm sure most of you know that Abilify is an atypical antipsychotic that's been repurposed as an add-on treatment for depression. As I noted earlier this year, since that FDA approval Abilify's sales exploded by 30 percent in 2008. The company has massively advertised the drug for depression in print media and on TV and here's the dynamic that has led to, according to the Los Angeles Times. "About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify 'might be right for them.' Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery. "Leuchter wondered what was up: Depressed patients... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2349708 Mon, 13 Apr 2009 04:00:00 +0100 2349708 http://www.medworm.com/index.php?rid=2326845&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fseroquel_killed_fda_panel_members_son.html A very interesting and sad account of the April 8 FDA psychopharmacology advisory committee hearing comes from Merrill Goozner's GoozNews: "I was rather shocked as the patient representative -- Margy Lawrence of Potomac, Md. -- on the panel announced her vote against approving the drug. 'My son died of sudden cardiac arrest,' she said. 'Seroquel was part of his cocktail.' "One has to wonder if the company knew in advance that someone with an obvious bias had been included on the committee. One has to wonder what the FDA, whose practices on advisory committees has been under scrutiny for years, was thinking when it decided to appoint someone who would appear on the surface to be incapable of offering a dispassionate analysis of the data. "The 2007 reform law required the FDA to reduce th... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2326845 Fri, 10 Apr 2009 04:00:00 +0100 2326845 http://www.medworm.com/index.php?rid=2326847&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Fseroquel_maker_plans_to_keep_pushing_fda_on_depression_approvals.html As many of you know already, an FDA advisory panel yesterday recommended against approval of Seroquel as a monotherapy and as a maintenance treatment for depression and recommended against approval for anxiety. In each case, it found the drug not sufficiently safe. The panel did recommend approval as an adjunctive treatment for depression. It's not clear to me how long people in trials for that particular indication were taking the drug. Anyway, here's how AstraZeneca spun things in a press release: "Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: 'We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognized the effectiveness of SEROQUEL XR as monother... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2326847 Thu, 09 Apr 2009 04:00:00 +0100 2326847 http://www.medworm.com/index.php?rid=2326849&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F04%2Ffda_panel_approves_seroquel_as_addon_depression_treatment.html News is just out that the FDA's psychopharmacology advisory panel has recommended that the agency approve Seroquel, an atypical antipsychotic, as an add-on or adjunctive treatment for depression, meaning to be taken in addition to anti-depressants. It recommended against approval as a monotherapy for depression and as a maintenance treatment for depression and as a treatment for anxiety. The recommendations now go to the full agency, which is not bound by them, for a final determination, likely in the near future. "Several panel members stressed that doctors should try other medicines for depression first before deciding to add Seroquel XR. "'I think this represents a second-line therapy,' said panel member Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Lo... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2326849 Wed, 08 Apr 2009 04:00:00 +0100 2326849 http://www.medworm.com/index.php?rid=2300346&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fharvard_child_psychiatrists_named_in_federal_subpoena.html I generally don't post on weekends, but news is just out that controversial Harvard child psychiatrist Joseph Biederman and his colleagues Tim Wilens and Thomas Spencer were named in a federal subpoena yesterday. The trio have all pulled in millions from pharma companies while also doing federally-funded research, a potentially illegal conflict of interest which was allegedly improperly reported. They are all being investigated by their university and NIH. The subpoena, issued by the US Attorney for Eastern Massachusetts, was served on Fletch Trammel, an attorney representing various states attorneys general and other plaintiffs in cases against pharma companies over pushing antipsychotics for use in children and adults. Apparently, the feds want whatever documents and depositions Trammel... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2300346 Sat, 28 Mar 2009 04:00:00 +0100 2300346 http://www.medworm.com/index.php?rid=2278003&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fharvard_child_psychiatrist_promised_drug_maker_positive_results_before_conducting_studies_of_antipsy.html The New York Times is reporting that controversial Harvard child psychiatrist Joseph Biederman was selling J&J/Janssen on results of clinical trials in children of its antipsychotic Risperdal and its stimulant Concerta in advance of conducting the actual studies. Biederman is of course the godfather of the alleged bipolar child diagnosis and took oodles of money from J&J and other pharma companies, and is under investigation by Sen. Charles Grassley for possible violations of federal research rules regarding conflicts of interest and by Massachusetts General Hospital. You can read my Biederman collection here. This stuff is amazing. "The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a p... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2278003 Fri, 20 Mar 2009 04:00:00 +0100 2278003 http://www.medworm.com/index.php?rid=2278002&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fsuppressed_seroquel_study_15_now_available.html I've obtained a copy of Seroquel Study 15, which AstraZeneca never published. It's a study of Seroquel's use in treating psychosis versus Haldol, finished in 1996 and submitted to the FDA as part of Seroquel's initial approval for use in treating schizophrenia. The results for Seroquel were not impressive. The drug was FDA approved in 1997. I am now making it available to the public with one caveat: it is 43 MBs and amounts to 3,459 pages, many of them deeply technical. I'm already well over my site's bandwidth limit for the month and am being hit with overage charges due to other Seroquel documents I've made available to the public. I simply cannot handle tons of people downloading this study until the first of the month. I'll see if I can put together an abridged version of the study wi... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2278002 Fri, 20 Mar 2009 04:00:00 +0100 2278002 http://www.medworm.com/index.php?rid=2278001&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fseroquel_documents_study_15_shows_seroquel_not_efficacious.html As noted elsewhere today, I've obtained a copy of Seroquel Study 15 which was conducted in the mid-1990s and which AstraZeneca suppressed and did not submit anywhere for publication, as the Washington Post and others have reported. The study was before Seroquel was approved by the FDA, was completed in 1996, and sought to measure Seroquel's efficacy at treating psychosis versus Haldol. After reading a portion of the very lengthy study, it's obvious why AZ didn't want this study published. It established that Seroquel wasn't a very efficacious antipsychotic at all with anywhere from 53 percent to 65 percent of patients in different Seroquel study groups withdrawing from the clinical trial due to psychotic relapse. That compares with 30 percent of Haldol patients who relapsed during the tri... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2278001 Fri, 20 Mar 2009 04:00:00 +0100 2278001 http://www.medworm.com/index.php?rid=2278006&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fwashington_post_claims_uproar_over_seroquel_cites_no_evidence.html There was an odd article in yesterday's Washington Post concerning suppressed Seroquel studies. It appeared on A-1 and was authored by Shankar Vedantam, who usually does good work. But this time out, not so much. First, the story is old news and contains little that hasn't been previously reported by myself, Bloomberg, the St. Petersburg Times and some other media outlets and blogs. Short story: Study 15 shows patients getting super fat on Seroquel; company knows it has problems with the drug; FDA approves the drug for schizophrenia in 1997; AstraZeneca never has study 15 published, but pushes into the public realm studies showing that the drug doesn't cause weight gain; later evidence shows that patients gain tons of weight and develop diabetes on the drug. That's it. Nothing new there, ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2278006 Thu, 19 Mar 2009 04:00:00 +0100 2278006 http://www.medworm.com/index.php?rid=2278009&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fhow_to_testify_to_fda_on_seroquel.html The FDA psychopharmacology advisory committee is holding hearings on AstraZeneca's applications to have its antipsychotic Seroquel approved by the FDA for one of three depression indications (including long-term maintenance) and anxiety. If you want to make your voice heard on this, there's information below on how you can do so. It is significant that the FDA is having the committee review the applications and offer its opinion instead of just approving the drug itself. Keep in mind that the committee is comprised mostly of psychiatrists and other researchers and that the committee is only making a recommendation to the full FDA. The committee does not approve a drug. Only the FDA proper can do that. You can either testify in person or in writing. It's 2009, but the FDA still makes no p... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2278009 Tue, 17 Mar 2009 04:00:00 +0100 2278009 http://www.medworm.com/index.php?rid=2260720&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fexemployees_claim_jj_offlabel_marketed_risperdal.html Among the many lawsuits floating around against makers of atypical antipsychotics is one brought against J&J/Janssen by former company sales reps, alleging that they were retaliated against for complaining about allegedly being pressed by the company to market Risperdal off-label for a host of conditions other than its then-approved use in schizophrenia. among other conditions, they allege that the company off-label marketed the drug for bipolar disorder well in advance of its approval for acute mania in 2003, for example. From Bloomberg: "J&J tried to promote Risperdal for conditions beyond schizophrenia, its approved use until December 2003, according to sworn statements among almost 1,000 pages of documents in the case in Trenton, New Jersey. To boost sales of the medicine, J&J urged ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2260720 Mon, 09 Mar 2009 04:00:00 +0100 2260720 http://www.medworm.com/index.php?rid=2232631&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fseroquel_documents_az_knew_of_weight_gain_problems_in_1997.html One reason I'm glad I made the Seroquel documents publicly available the other day is because I knew people like Jim Edwards at BNET.com would go dig through them and post their findings, saving me from writing too much about a drug that injured me personally. Edwards wrote an excellent post yesterday detailing what AstraZeneca knew about weight gain problems with Seroquel and it appears the company knew about it as far back as 1997, the year the drug was first approved. "Feb 12, 1997, memo from Richard Lawrence: I am not 100% comfortable with this data being made publically available at the present time … however I understand we have little choice … Lisa has done a great ’smoke-and-mirrors’ job! "Aug. 13, 1997, memo from Lisa Arvanitis to her colleagues: 1. Is there a competiti... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2232631 Wed, 04 Mar 2009 05:00:00 +0100 2232631 http://www.medworm.com/index.php?rid=2232633&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Ffda_panel_to_review_seroquel_approval_du_to_weight_gain_blood_sugar_issues.html As I mentioned last week, the FDA's psychopharmacology advisory panel is going to review the possible approval of Seroquel for three depression indications and anxiety in early April. My hunch was that the clinical trials must be producing loads of fat, high-blood sugar patients, especially since one of the depression indications for which approval is being sough is for "maintenance," meaning long-term use. Reuters is out today with a brief note on the April 8 hearing: "The issues for discussion at the April 8 meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA meeting notice said. "Tardive dyskinesia causes involuntary, repetitive movement of the limbs and lip smacking,... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2232633 Tue, 03 Mar 2009 05:00:00 +0100 2232633 http://www.medworm.com/index.php?rid=2227206&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F03%2Fseroquel_documents_now_available.html As many of you know, a bunch of documents in the federal lawsuit against AstraZeneca over allegations surrounding its drug Seroquel were released in open court Feb. 26. The next day, I obtained the entire set of pdfs and after reading all of them over the weekend, I am now making them publicly available. The set of documents in .zip format runs to 44 MB. They will also become available on other sites soon. It's going to be a day or so more before I write about them myself, beyond what I offered on the initial press accounts of these documents last week. There's enough evidence of downplaying of side effects and risks in these documents that I need to divorce my personal frustrations from the evidence. For those who don't know, I took the drug for 14 months in 2004 and 2005 and it caused m... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2227206 Mon, 02 Mar 2009 05:00:00 +0100 2227206 http://www.medworm.com/index.php?rid=2222563&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F02%2Fseroquel_documents_company_ordered_sales_reps_to_lie_1.html From this morning's Wall Street Journal: " ORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representatives to tell doctors that its powerful psychiatric drug, Seroquel, didn't cause diabetes even though a company physician had at one point stated years earlier that such a link was probable in some individuals, documents unsealed in a federal court case here show. "The documents -- ranging from unpublished study results to previously undisclosed depositions -- are among more than 100 the U.K. drug maker agreed to unseal Thursday in lawsuits brought by plaintiffs who allege they were harmed by the multibillion-dollar antipsychotic drug. Many of the cases have been consolidated ..." The rest of the story is behind the subscriber firewall, so until someone passes it along to me o... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2222563 Fri, 27 Feb 2009 05:00:00 +0100 2222563 http://www.medworm.com/index.php?rid=2216599&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F02%2Fseroquel_sex_and_major_conflicts_of_interest_between_astrazeneca_exec_and_british_researcher_us_ghos.html There's been much news of conflict of interest between pharmaceutical companies and outside researchers possibly biasing the results of studies of psychiatric drugs over the last year. Notably, Sen. Charles Grassley (R-Iowa) has exposed researchers at Harvard University, Emory University and George Washington University, among others, as being locked in questionable alliances with companies such as Johnson & Johnson and GlaxoSmithKline. The researchers get hundreds of thousands of dollars and, then, perform research favorable to a company's drugs and often tout those drugs before their peers, claiming their research is independent of bias. The entire affair, along with revelations about how continuing medical education programs are funded, has given psychiatry a serious image problem and l... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2216599 Wed, 25 Feb 2009 05:00:00 +0100 2216599 http://www.medworm.com/index.php?rid=2200561&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F02%2Fhospital_officials_jailed_in_california_charged_with_elder_abuse_via_psych_meds.html I'm not making this up. Yesterday, California Attorney General Jerry Brown filed a criminal complaint against three officials at a Lake Isabella, California nursing home. From the Los Angeles Times: "The state attorney general's office contended in a criminal complaint that more than 20 residents at a skilled nursing center run by the Kern Valley Healthcare District were drugged 'for staff convenience.' Many of them experienced side effects that included dramatic weight loss, slurred speech, tremors, loss of cognition and even psychosis, according to the complaint." It's been a very long time since I've seen hospital officials charged with crimes. Expected to be arraigned later today are Hoshang M. Pormir, former medical director, former nursing director Gwen D. Hughes and former chief p... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2200561 Fri, 20 Feb 2009 05:00:00 +0100 2200561 http://www.medworm.com/index.php?rid=2182576&cid=t_120652_140_f&fid=34843&url=http%3A%2F%2Fwww.furiousseasons.com%2Farchives%2F2009%2F02%2Frolling_stone_article_on_zyprexa_antipsychotics_contains_error_odd_omissions.html After putting up the original post, I went back and slightly changed the portion where I discuss RS's handling of patient accounts in the article. I had overstated something and wanted to correct it. PD Two weeks ago, I noted that a just-published Rolling Stone article had detailed the scandal around the atypical antipsychotic Zyprexa and delved into how its maker, Eli Lilly, had engaged in deceptive marketing of the drug off-label for some psychiatric conditions. Regular readers of this site know that I gave a lengthy interview to Ben Wallace-Wells, a contributing editor for RS, but that he failed to credit me or this site in any way. At the time, I hadn't read his article yet, as it was unavailable on newsstands or online. I've now read the article (now online) several times. I've held ... Furious Seasons blogs http://www.medworm.com/rss/comments.php?id=2182576 Thu, 12 Feb 2009 05:00:00 +0100 2182576