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 'abilify'. Sat, 03 Sep 2011 02:09:29 +0100 http://www.medworm.com/index.php?rid=4921560&cid=t_110558_113_f&fid=34634&url=http%3A%2F%2Fwww.emrandhipaa.com%2Femr-and-hipaa%2F2011%2F06%2F01%2Fdrug-mailings-and-patient-privacy%2F Many of you have quickly realized that I find it a lot more interesting to write about EMR than I do about HIPAA. Seems like most people prefer to read about EMR than they do HIPAA as well (except for this popular HIPAA Lawsuits post I did eons ago). However, I’m sure that many of you will find this article I found about privacy of medical data quite interesting. Here’s a quote from the beginning of the article which prefaces the health privacy situation quite well. A pharmaceutical company, Bristol-Myers Squibb Co., sent him an eight-page brochure pitching another medicine, Abilify, used to treat patients “when an antidepressant alone isn’t enough.” Lexapro was plenty for Spencer, but the mailing stuck in his craw. He has followed the recent debate over the u... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=4921560 Wed, 01 Jun 2011 20:40:22 +0100 4921560 http://www.medworm.com/index.php?rid=4853218&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYC8nXoQY5XE%2F In the latest example of who antipsychotics are being prescribed inappropriately, Florida’s state-run jails and residential homes are regularly giving large doses of the meds but not for uses that were approved by the FDA. And in some cases, the drugs are prescribed by contract doctors who have taken speaking fees and other gifts from drugmakers, according to The Palm Beach Post. As a result, the state’s Department of Juvenile Justice has ordered a review. “The questions recently brought to our attention are serious, and deserve answers based on a careful, thorough and independent review of the facts,” DJJ Secretary Wansley Walters tells the paper, which ran a two-part series about the problem (read here and here). The series raises familiar questions about the exte... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853218 Mon, 23 May 2011 15:08:23 +0100 4853218 http://www.medworm.com/index.php?rid=4789639&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0g87fDI2KB0%2F Was the evidence used for prescribing Abilify to combat bipolar disorder skimply? That’s the contention in a new paper, which argues the justification for using the Bristol-Myers Squibb drug as maintenance treatment was based on one long-term, controlled trial that had numerous limitations. Moreover, the paper maintains these limitations were not identified in many of 104 subsequent review articles and treatment guidelines. For its part, Bristol-Myers disagrees (keep reading). The original trial was published in the American Journal of Psychiatry in 2003 and compared the safety and efficacy of Abilify with placebo for treating bipolar patients. The study concluded that the pill had “significantly greater efficacy than placebo for the treatment of bipolar disorder patients in ac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789639 Wed, 04 May 2011 15:04:41 +0100 4789639 http://www.medworm.com/index.php?rid=4610996&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRIn2KcUFrXo%2F In an unusual move, the California Insurance Commissioner has intervened, or joined, a whistleblower lawsuit that was filed in 2007 by three former Bristol-Myers Squibb employees, who charged the drugmaker with bribing doctors to prescribe its meds - Abilify, Avapro, Glucophage, Plavix, BuSpar, Pravachol and others. In all, private insurers in the state paid more than $3.5 billion to cover the drugs. “This sort of fraud has long plagued our health insurance system, leading to billions of dollars annually in added health care costs nationally,” Insurance Commissioner Dave Jones says in a statement. “Besides the obvious and deplorable ethical violations in such cases, health care fraud also leads to higher premiums for consumers and an unnecessary and unjust increase in hea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4610996 Fri, 18 Mar 2011 22:20:28 +0100 4610996 http://www.medworm.com/index.php?rid=4507576&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhf6Mo6pHvdw%2F The FDA issued a safety alert today about the risks of exposure of nearly two dozen antipsychotics to newborns when the drugs are taken by women during pregnancy. Specifically, the pregnancy section of drug labeling for the entire class was updated to include info about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns. In searching its adverse events database, the agency has, so far, identified 69 cases of neonatal EPS or withdrawal through October 29, 2008, involving all antipsychotics. The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. And symptoms varied in severity: in some newborn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507576 Tue, 22 Feb 2011 23:28:04 +0100 4507576 http://www.medworm.com/index.php?rid=4377790&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfND27RYyNr4%2F The Internet may be ubiquitous, but to what extent do consumers trust the growing numbers of web sites catering to corporate messages, specific meds and disease information? To quantify this growing morass, a research firm asked more than 6,600 US adults in last year’s fourth quarter for their reactions to various sites and the available information, and here is what they found… When it comes to corporate websites, 37 percent expressed trust “to some degree” and 17 percent reported a lack of trust, with everyone else feeling neutral. Web sites for specific meds generated a slightly higher level of trust with 41 percent feeling comfortable and 14 percent expressing a lack of trust. As for disease sites, 37 percent viewed the site as trustworthy and 15 percent did not... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377790 Thu, 20 Jan 2011 14:09:15 +0100 4377790 http://www.medworm.com/index.php?rid=4179519&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuFNz5Akkn8M%2F Earlier this year, US Senator Chuck Grassley asked all 50 states to provide data on doctors who wrote huge numbers of prescriptions for specific drugs that are paid for by Medicaid programs. The move was prompted by reports indicating certain meds - notably, several widely used antipsychotics, as well as the OxyContin painkiller and Xanax anxiety pill - have been prescribed at particularly high rates. The purpose in launching this inquiry was to determine whether the drugs are overprescribed and, consequently, costing taxpayers unnecessarily. And so Grassley, who is the ranking Republican on the committee and has launched several probes into the pharmaceutical industry, recently followed up with the Department of Health and Human Services in hopes of learning how the agency oversees paymen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179519 Thu, 18 Nov 2010 22:19:22 +0100 4179519 http://www.medworm.com/index.php?rid=4172329&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFbCJyugESOg%2F Rise and shine. Another day is on the way. Although, clouds are hovering over the Pharmalot corporate campus. Nonetheless, we are reminded, once again, of what the Morning Mayor would say: ‘Every brand new day should be unwrapped like a precious gift.’ We urge you to tug on the ribbon. And, of course, please join us for a cup of stimulation and the news of the world. Have a great day, everyone… Docs Say Bloodthinner Race Is Too Close To Call (Reuters) Patent Upheld On Bristol-Myers Abilify Schizophrenia Med (Bloomberg News) Value-Based Pricing Is No Magic Bullet: ABPI (InPharm) FDA Approves Eisai Med For Breast Cancer (Bloomberg News) Pfizer Signs R&D Deal With UC San Francisco (The Wall Street Journal) Merck Loses 50 Execs In India (The Economic Times) Lupus Drug To... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4172329 Tue, 16 Nov 2010 13:12:47 +0100 4172329 http://www.medworm.com/index.php?rid=3581841&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHBVEEExbnfk%2F For the second year in a row, the growth in the use of prescription drugs by youngsters exceeded all other age groups. In fact, the increase was nearly four times higher than in the overall population, partly because there were a slew of new indications for existing meds that traditionally treat “adult diseases, according to the latest annual report from Medco Health Solutions. Which drugs and indications? WelChol and Crestor for children aged 10 to 17 with heterozygous familial hypercholesterolemia; Protonix for erosive esophagitis in patients aged 5 and up; Abilify for irritability associated with autistic disorder in children aged 6 to 17; Atacand for hypertension in children aged 1 to 17; Zyprexa for schizophrenia and acute mania (bipolar I) in children ages 13 to 17; Axert for acute... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581841 Wed, 19 May 2010 18:59:01 +0100 3581841 http://www.medworm.com/index.php?rid=3416281&cid=t_110558_137_f&fid=39091&url=http%3A%2F%2Falzheimmers.blogspot.com%2F2010%2F03%2Fwhat-are-antipsychotics.html Antipsychotics are a group of medications used to treat a whole host of disorders and symptomatology. Generally speaking they are terribly misunderstood, dreaded and the subject of much hatred and controversy. They stir up a lot more emotion than say an anti-hypertensive to treat high blood pressure or an oral hypoglycemic to treat type II diabetes. They are also responsible for saving many lives. They are also responsible for helping many chronically mentally ill people live and function outside of a state mental facility.they have been around for a long time, the original developed in the early 1950's and that was Thorazine. A whole host of medications followed, the so-called typical antipsychotics or first generation antipsychotics. more common ones still frequently used (but not as muc... Caregiver Survival: I Hate Alzheimer's blogs http://www.medworm.com/rss/comments.php?id=3416281 Fri, 05 Mar 2010 22:33:00 +0100 3416281 http://www.medworm.com/index.php?rid=3197885&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_5l-Xitz6Rs%2F For those wondering about the reactions that some consumers have to DTC television ads, some decide to search for more info online. So which ads are prompting the most activity and which product sites are visited? NuvaRing and Latisse had the highest percentage of overall product website traffic driven by their DTC TV ads, according to Manhattan Research. NuvaRing, which is a contraceptive made by Merck, jumped five spots from last year to take the top ranking. And as you can see, Allergan’s new eyelash enhancement treatment, Latisse, grabbed the No. 2 spot. Unfortunately, there was no corresponding info to contrast the amount of ad spending with web traffic. In any event, here is the list of the ten brands for which DTC ads drove the most web traffic… 1. NuvaRing 2. Latisse ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197885 Fri, 22 Jan 2010 13:19:09 +0100 3197885 http://www.medworm.com/index.php?rid=3176121&cid=t_110558_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2F1fcV9LKHq8w%2Fas-seen-on-tv-pharmas-top-websites.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3176121 Thu, 14 Jan 2010 19:23:00 +0100 3176121 http://www.medworm.com/index.php?rid=3101063&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvHCjUUN-yas%2F The federal government has stopped reimbursing a Miami doctor who wrote nearly 97,000 prescriptions for mental health drugs - such as antipsychotics - to Medicaid patients over 18 months, the Associated Press reports. And the case has prompted Chuck Grassley, the Republican Senator from Iowa, to call for a nationwide investigation. Fernando Mendez-Villamil wrote an average of 153 prescriptions a day for 18 months ending in March 2009, according to Grassley. That’s nearly twice the number of the second highest prescriber in Florida, who wrote a little more than 53,000 prescriptions, according to a list compiled by state officials, the AP writes. Grassley, who is a ranking member of the Senate Finance Committee, which oversees Medicare and Medicaid, sent a letter this week to the Depar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3101063 Fri, 18 Dec 2009 11:59:11 +0100 3101063 http://www.medworm.com/index.php?rid=3071466&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLlpwzU6UBgw%2F An FDA official says the agency is considering strengthening the labels to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults, Dow Jones writes. Tom Laughren, who heads the FDA’s division of psychiatric products, says the agency asked drugmakers to provide all their info on metabolic side effects such as increases in blood glucose, which can cause diabetes, and blood cholesterol levels which can lead to cardiovascular problems over time. The labels already mention weight gain and related problems, but Laughren says the FDA is considering putting all the info in the warnings section, which is tantamount to a stronger label. He made his comments yesterday at a pediatric advisory committee meeting held to review the safety of s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3071466 Wed, 09 Dec 2009 13:43:43 +0100 3071466 http://www.medworm.com/index.php?rid=3019234&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtqORbrPPWwI%2F Hello, everyone. And welcome to a shorter working week, at least here in the states. Although, we suspect the next couple of days will be jam-packed, as everyone tries to squeeze a lot of work into not a lot of time. In any event, time to grab a cup of stimulation and dig in. Hope your day goes well… Merck-Sorono Opening R&D Hub In China (The Wall Street Journal) Abbott’s Meridia Linked To Cardiovascular Events (PharmaTimes) Pfizer Must Pay $6.3M In Damages Over Prempro (Bloomberg) FDA OKs Abilify For Child Autism Irritability (Reuters) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3019234 Mon, 23 Nov 2009 13:05:38 +0100 3019234 http://www.medworm.com/index.php?rid=2939559&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FolKsJTYHnyw%2F Nursing homes throughout Illinois are being dosed with powerful psychotropic drugs, leading to tremors, dangerous lethargy and a higher risk of harmful falls or even death, according to an investigation by The Chicago Tribune. Thousands of elderly and disabled people have been affected, many of them drugged without their consent or without a legitimate psychiatric diagnosis that would justify treatment, according to state and federal inspection reports reviewed by the paper. The Trib identified 1,200 violations at Illinois nursing homes involving psychotropic medications since 2001. Those infractions affected 2,900 patients, the paper writes, adding that the actual numbers are likely far higher because regulators inspect some facilities just once every 15 months, and even then they usually... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939559 Thu, 29 Oct 2009 12:54:55 +0100 2939559 http://www.medworm.com/index.php?rid=2934951&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2yEljf_YhnM%2F Anywhere from 10 to 19 pounds on the Lilly pill. A study in the Journal of the American Medical Association found kids’ weight zoomed in the first three months on antipsychotics, often leading to elevated cholesterol and triglycerides levels. Weight gain is a known side effect but, as Forbes reminds us, the results are noteworthy because there were far greater increases than seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class. AstraZeneca’s Seroquel, Bristol-Myers Squibb’s Abilify and Johnson & Johnson’s Risperdal caused weight gain... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2934951 Tue, 27 Oct 2009 21:38:07 +0100 2934951 http://www.medworm.com/index.php?rid=2899193&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4Nh-NkSCl3I%2F Now who’s schizophrenic? Just six months after extending its contract with Otsuka Pharmaceutical to market the Abilify anti-psychotic, the big drugmaker has cut about 25 percent of its Abilify sales team, according to Bloomberg, which notes the pill is the company’s second-biggest seller. The move happened this week, according to a Bristol-Myers spokesman, who declined to provide specific numbers. “We’re evaluating our resources and determining the most appropriate structure for our sales force,” he told Bloomberg. “It’s an important product for both companies.” Speculation on CafePharma, where reps love to dish the industry dirt, suggests Otsuka will fill the void and may hire some Bristol-Myers reps. Bristol-Myers sells Abilify in the US and sever... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2899193 Fri, 16 Oct 2009 12:59:54 +0100 2899193 http://www.medworm.com/index.php?rid=2417159&cid=t_110558_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F05%2Fandy-behrman-now-anti-bms-spokesperson.html The saga of the Andy Behrman, the patient that Bristol-Myers Squibb (BMS) paid hundreds of thousands of dollars (but balked at paying him millions) to help promote its drug Abilify, continues.Jim Edwards of BNET Pharma reports that Behrman has resorted to an e-mail campaign that Edwards says is a "long plug" for Behrman's new book (see "Andy Behrman Resorts to Spam in Fight vs. BMS and Abilify").In reading Behrman's e-mail message I found a link to a 60-second anti-Abilify video ad he posted to YouTube ("Abilify Kills"; see below). This "anti-ad" lists several of the side effects of Abilify and finishes with a twist on the famous "Ask Your Doctor" closing found in all DTC Rx drug ads: "Ask your doctor if Abilify is wrong for you."Now that Mr. Behrman is getting so much media attention and ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2417159 Tue, 19 May 2009 11:16:00 +0100 2417159 http://www.medworm.com/index.php?rid=2415772&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F05%2Fabilify-spokesperson-andy-behrman.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2415772 Fri, 15 May 2009 17:27:00 +0100 2415772 http://www.medworm.com/index.php?rid=2405420&cid=t_110558_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F11%2Fhiding-akathisia-in-abilify%2F What if your new drug has an unwanted side effect that’s going to impact sales if it becomes widely known? Well, in the case of Abilify (aripiprazole) apparently, you make that side effect’s data difficult to find (or just fail to report it when it’s ugly). CL Psych has the scoop: The authors go through a long list of second-generation antipsychotic medications. The drug that receives the least attention is aripiprazole (Abilify). The authors conclude that “in studies comparing aripiprazole with placebo, akathisia rates in the aripiprazole arm were similar in some studies, and higher in others. As with other SGAs, akathisia rates with aripiprazole were lower than those of FGAs.” So Abilify causes less akathisia than older medications and it’s unclear ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2405420 Mon, 11 May 2009 20:29:27 +0100 2405420 http://www.medworm.com/index.php?rid=2398804&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2FyMKGOHqSXvk%2Fif-youve-been-reading-about-abilify-for.html If you've been reading about Abilify for depression on this site, you've probably noticed that I've been down on Abilify for causing akathisia in a frighteningly high percentage of patients. In two recent trials, akathisia occurred in 25% of Abilify patients compared to 4% of placebo patients. What, exactly, is akathisia? That's still a matter of some debate. Let's turn to a recent Journal of Clinical Psychiatry article on the topic. Entitled "Akathisia: An Updated Review Focusing on Second-Generation Antipsychotics," the paper purports to provide "a review of the literature on the incidence of drug-induced akathisia associated with the use of second-generation antipsychotics (SGAs) and first-generation antipsychotics (FGAs)."It provides a few different characteristics associated with acut... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=2398804 Thu, 07 May 2009 17:53:00 +0100 2398804 http://www.medworm.com/index.php?rid=2376205&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2FwXLK6FBtbrA%2Fabilify-runs-amok-runs-stealth-safety.html Furious Seasons has a rather distressing piece of news from a recent Bristol-Myers Squibb conference call. To sum it up quickly, BMS claims that 10.6% of depressed patients are now receiving atypical antipsychotics. Of those 10.6%, 21.7% are taking Abilify. So that would mean roughly 10-11 in 100 depressed patients are taking antipsychotics and 2 of them are on Abilify. I shudder to think how many are on Seroquel. Or Zyprexa. It made me think of a post I wrote a few weeks ago in which I described the marketing of Abilify for depression. A huge market of depressed people just ripe for the picking.Going along with this, BMS is pushing back on the issue of akathisa, the side effect that has garnered the drug much bad publicity (at least in the blog world; 1, 2, 3) via a medical journal articl... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=2376205 Wed, 29 Apr 2009 12:45:00 +0100 2376205 http://www.medworm.com/index.php?rid=2348505&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2Fl8VGMViKr6c%2Fabilify-marketing-blitz-atypical.html "The results are extremely unimpressive; they just squeak by," says Massachusetts psychiatrist Daniel Carlat, editor of the respected Carlat Psychiatry Report. For a clinician or a patient's family, the difference between those on Abilify and those who took a placebo "would be hard to actually see," he adds.Dr. Carlat is referring to the comparison between Abilify and placebo in the treatment of depression, a topic I have discussed in depth previously (1 , 2 , 3, 4). The above quote comes from a Melissa Healy piece in the Los Angeles Times that throws a damper on Abilify's parade through depression.Another Melissa Healy piece from the LA Times starts off as follows:About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychoti... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=2348505 Tue, 14 Apr 2009 12:49:00 +0100 2348505 http://www.medworm.com/index.php?rid=2300285&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F03%2Ffurious-seasonsharvard-child.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2300285 Sat, 28 Mar 2009 18:18:00 +0100 2300285 http://www.medworm.com/index.php?rid=2300289&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F03%2F2008-antipsychotic-sales-146-billion.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2300289 Thu, 26 Mar 2009 09:31:00 +0100 2300289 http://www.medworm.com/index.php?rid=2268153&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F03%2Fastrazeneca-applauds-appointment-of.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2268153 Mon, 16 Mar 2009 15:21:00 +0100 2268153 http://www.medworm.com/index.php?rid=2268191&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F03%2Fastrazeneca-in-courtseroquel-internal.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2268191 Sun, 15 Mar 2009 16:41:00 +0100 2268191 http://www.medworm.com/index.php?rid=2268245&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F03%2Fseroquel-treatment-for-alcoholism-wayne.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2268245 Sat, 14 Mar 2009 18:08:00 +0100 2268245 http://www.medworm.com/index.php?rid=2222737&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F02%2Ffda-warningtardive-dyskinesia.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2222737 Sat, 28 Feb 2009 17:34:00 +0100 2222737 http://www.medworm.com/index.php?rid=2177609&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F02%2Fabilify-dtc-walk-down-memory-lane-from.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2177609 Wed, 11 Feb 2009 03:13:00 +0100 2177609 http://www.medworm.com/index.php?rid=2150866&cid=t_110558_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F02%2Fclinical-psychology-and-psychiatry.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2150866 Sun, 01 Feb 2009 17:32:00 +0100 2150866 http://www.medworm.com/index.php?rid=2101073&cid=t_110558_140_f&fid=35448&url=http%3A%2F%2Fseemedlikeagoodideathetime.com%2F2009%2F01%2F13%2Fincoherent-blogging-its-finest%2F Previous post moved. exit stage left Other things: WPress.  When you make a blog private here, you cannot just add someone by inserting their email; they have to get a user name-that is then entered into the “view” list.   I haven’t decided how to rectify this situation yet. Open to suggestions. UM knows what I’m talking [...] (Source: bipolar chicks blogging) bipolar chicks blogging blogs http://www.medworm.com/rss/comments.php?id=2101073 Wed, 14 Jan 2009 04:28:34 +0100 2101073 http://www.medworm.com/index.php?rid=2018097&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F475704352%2F The common distinction between first- and second-generation antipsychotics has no scientific basis and should be dropped, according to a paper in The Lancet. A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotics are more effective than older drugs for symptoms of schizophrenia, MedPage Today writes. The researchers also found that, although newer drugs induced fewer extrapyramidal effects (including tremor, slurred speech, restlessness, movement disorders, among other things) than Haldol, which is also known as haloperidol, this did not occur when compared with low-potency first-generation agents. “Second-generation antipsychotic drugs differ in many properties” - including structure and mode of action as well as clinica... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2018097 Fri, 05 Dec 2008 13:59:21 +0100 2018097 http://www.medworm.com/index.php?rid=1981285&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F461099196%2F Brad Pitt and Matt Damon may turn sales reps into stars. Their production companies are reportedly looking at Andy Behrman’s tell-all book about his days as a paid spokesman for the Abilify antipsychotic for Bristol-Myers Squibb, according the Rush & Molloy gossip column in The New York Daily News. Behrman, who wrote “Electroboy: A Memoir of Mania,” a memoir of mania, bipolar disorder and his experiences undergoing ECT, calls his latest “Adventures in the Drug Trade: I Was a Big Pharma-Pusher.” He was taking Abilify but stopped two years ago after some difficulties and severed his relationship with the drugmaker. The manuscript is due to go to publishers in January, after Behrman’s nondisclosure agreement with the drugmaker expires, the gossips say.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1981285 Fri, 21 Nov 2008 19:44:48 +0100 1981285 http://www.medworm.com/index.php?rid=1975632&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F460067600%2F – Earlier this week, the FDA advisory committee slammed the rising use of antipsychotics in youngsters, particularly to treat attention deficit disorders. The meds, you see, were approved by the agency for schiozphrenia or bipolar disorder - and only recently for youngsters, in some cases (back story). The trend, however, to prescribe these meds for teenagers and children has actually been widespread, with Medicaid programs in several states reporting rising expenditures for antipsychotics to treat ADD or ADHD. A report issued last year by the University of South Florida found that among children 5 years or younger, 53.8 percent were prescribed antipsychotics for a diagnosis of ADHD. The figure was 48.8 percent for children between 6 and 12 years old (see page 22). The issue is gaini... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975632 Thu, 20 Nov 2008 22:08:49 +0100 1975632 http://www.medworm.com/index.php?rid=1927873&cid=t_110558_140_f&fid=35448&url=http%3A%2F%2Fseemedlikeagoodideathetime.com%2F2008%2F11%2F03%2Fmy-assistant-scientists%2F I don’t usually see a lot of commercials on network tv; but my scientific assistant, wanted to pick a fight watch SNL. I was watching with my eyes closed when I thought I heard, “2 out of 3″ not sure on that number; but am pretty sure or it would not have grabbed my attention [...] (Source: bipolar chicks blogging) bipolar chicks blogging blogs http://www.medworm.com/rss/comments.php?id=1927873 Mon, 03 Nov 2008 07:02:16 +0100 1927873 http://www.medworm.com/index.php?rid=1640370&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F340735021%2F A group of 17 New Hampshire legislators want the state’s Attorney General to pursue a criminal investigation into several drugmakers that sell antipsychotics after learning the state’s Medicaid program has spent increasingly large amounts on these medications for children. In a May 6 letter, the legislators wrote that “civil actions merely appear to be write-offs as business expenses to drug manufacturers in cases like Vioxx, OxyContin, Neurontin, Paxil and those mentioned above. A criminal deterrent is needed to protect our children and others placed on powerful medications.” Their letter notes state spending rose from $300,000 in 2000 to $4 million last year. Last week, the state announced it would receive $1.2 million as its share of a national settlement paid b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1640370 Sun, 20 Jul 2008 15:57:40 +0100 1640370 http://www.medworm.com/index.php?rid=1522436&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F313254592%2F The agency is requiring manufacturers of “conventional” antipsychotic drugs to change the labeling to warn about an increased risk of death associated with the off-label use to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Black Box warnings were added, and will now be added to the older “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis, according to an FDA statement. Both classes of drugs are dopamine receptor antagonists work by blocking the action of na... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1522436 Mon, 16 Jun 2008 19:47:12 +0100 1522436 http://www.medworm.com/index.php?rid=1393765&cid=t_110558_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F276157101%2Fabilify_may_be_effective_in_tr.html Dr. Henry R. Kranzler and colleagues from the University of Connecticut Health Center, Farmington believe that the use of Abilify (aripiprazole) may be of use to patients battling an addiction to alcohol.Abilify, a drug used to treat the symptoms of psychosis in patients with schizophrenia and bipolar disorder was found to increase the sedative effects of alcohol and decrease the euphoric effects. The drug apparently works by affecting the dopamine receptors in the brain and thus reducing the reinforcing effects of alcohol.While treatment with Abilify was generally well tolerated, researchers found that the most commonly reported adverse effect was tiredness, nausea, headache and difficulty sleeping.The researchers agree that while the drug has potential in the treatment of alcohol addicti... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1393765 Wed, 23 Apr 2008 14:00:01 +0100 1393765 http://www.medworm.com/index.php?rid=1370872&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F269961795%2F Four years ago, Lilly and several other drugmakers proposed the creation of The Florida Behavioral Health Collaborative. And they provided $10 million to the state to get it up and running. Soon, an expert panel was convened and recommended state standards, and national scholars with financial ties to drugmakers that sell atypicals were invited to participate, according to The Tampa Bay Tribune. To treat schizophrenia, the panel decided docs should first try an atypical - a newer generation of meds that includes Risperdal, Seroquel, Zyprexa, Geodon and Abilify. If that didn’t work, they should try a different atypical. If that still didn’t work, they should try a third atypical or one of the older generation drugs, the paper writes. A Lilly spokeswoman tells the paper the goal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1370872 Mon, 14 Apr 2008 11:49:01 +0100 1370872 http://www.medworm.com/index.php?rid=1340571&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F261941446%2Fabilify-for-depression-second-round-lot.html In July 2007, I posted about a very strangely designed study that claimed to show Abilify was an effective treatment for depression when added to antidepressant medication. Here is what I wrote about it then...Study Design. Patients were initially assigned to receive an antidepressant plus a placebo for eight weeks. Those who failed to respond to treatment were assigned to Abilify + antidepressant or placebo + antidepressant. Those who responded during the initial 8 weeks were then eliminated from the study. So we've already established that antidepressant + placebo didn't work for these people -- yet they were then assigned to treatment for 6 weeks with the same treatment (!) and compared to those who were assigned antidepressant + Abilify. So the antidepressant + placebo group started at... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1340571 Tue, 01 Apr 2008 12:39:00 +0100 1340571 http://www.medworm.com/index.php?rid=1332726&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F259581561%2F The so-called atypicals - including Abilify, Risperdal, Zyprexa, Seroquel and Geodon - have been hailed as more effective and easier to tolerate than the older and cheaper kind such as Haldol, which cause tremors and rigid muscles. But the new generation are no better at treating a first episode of schizophrenia, according to a study in The Lancet. Such findings are important because the atypicals are heavily promoted, widely prescribed and expensive. The Dutch researchers studied 498 patients between 18 and 40 years old in Europe and Israel in an open trial lasting 12 months. The patients were randomly assigned to a low-dose version of Haldol, or a higher dose of one of four atypicals. They found that during the subsequent 12-month period, more patients taking Haldol discontinued treatmen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1332726 Fri, 28 Mar 2008 11:23:29 +0100 1332726 http://www.medworm.com/index.php?rid=1331524&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F259253194%2F Otsuka American Pharmaceutical, the US unit of the Japanese drugmaker, agreed to pay more than $4 million to resolve allegations that it marketed the Abilify antipsychotic for off-label uses, according to the US Department of Justice. The settlement resolves allegations that, from 2002 through 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis, although at the time, the FDA had not approved the drug for use in geriatric patients, teenagers or children. Last November, the FDA did approve Abilify for teenagers. Otsuka developed Abilify in Japan and then entered an agreement with Bristol-Myers to co-promote the drug in the US. Bristol-Myers paid $515 million last September to settle the same allegations. Meanwhile, the whistle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1331524 Thu, 27 Mar 2008 21:58:06 +0100 1331524 http://www.medworm.com/index.php?rid=1283629&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246941000%2F Antipsychotic Promotional Spending In ‘06 Drug Spending Abilify $329 million Zyprexa $189 million Risperdal $179 million Seroquel $179 million Geodon $119 million Sometimes, money really can’t buy everything. Despite outspending its rivals by huge sums, Bristol-Myers Squibb’s Abilify failed to make much of an impression on a group of psychiatrists and primary care docs surveyed recently. As the first table illustrates, Bristol spent $329 million to promote Abilify in 2006, and this included unspecified costs in reaching docs, samples, DTC ads, detailing, advertising in medical journals, and mailing reprints, according to Sandra Chow, an analyst at Decision Resources, which queried 62 psychiatrists and primary care physicians. This amount was significantly m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1283629 Thu, 06 Mar 2008 19:54:07 +0100 1283629 http://www.medworm.com/index.php?rid=1274974&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F244846273%2F Connecticut’s nursing homes dole out antipsychotic drugs to residents who do not have psychotic disorders at one of the highest rates in the country, raising questions about whether the medications are being used to subdue agitated patients because of a lack of staffing and attention to alternate treatments, The Hartford Courant reports. Federal data from the Centers for Medicare & Medicaid Services show that since 2005, Connecticut has consistently ranked in the top four states in the prevalence of antipsychotic drugs dispensed to nursing home residents who have no psychotic or related conditions. In the most recent quarterly report, through September 2007, only Louisiana had a higher prevalence rate than Connecticut, where more than 26 percent of residents who lacked an approp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1274974 Mon, 03 Mar 2008 13:26:37 +0100 1274974 http://www.medworm.com/index.php?rid=1241899&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F237620558%2Fwhy-i-love-discussion-section.html A recent study in the Journal of Clinical Psychopharmacology found that aripiprazole (Abilify) offered no benefit over placebo in treating biploar depression. Well, at least that's what the results showed, but the discussion section told a bit of a different story. At the end of eight weeks, Abilify failed to beat placebo on either the Montgomery-Asberg Depression Rating Scale or the Clinical Global Impressions -- Bipolar Severity of Illness Scale. It is rare that an industry-sponsored article reports negative results and it would be nigh-impossible to find a published industry-sponsored study that failed to put a happy spin on the negative results. Sure, the results were negative in this study, but if the dosing was different, the treatment could have worked. There's always a loophole, so... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1241899 Tue, 19 Feb 2008 15:10:00 +0100 1241899 http://www.medworm.com/index.php?rid=1155863&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F217648340%2Fzetia-just-latest-chapter-in-hiding.html There have been many interesting posts written about how data regarding Zetia were buried for quite some time. One of the main storylines in this saga is that it took about two years after the study was completed to analyze and release the data. The most disappointing aspect of this story is that few if any outlets are noting that this is not a fluke event. Clinical trials are a huge part of how drugs are marketed. After examining clinical trial data, physicians who prescribe their drug believe they are engaging in evidence-based medicine. Granted, most physicians have little training in actually understanding statistics or research design, which are key in understanding clinical trial evidence. But that's not the point of this post...The point is that Zetia is just the latest chapter in a... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1155863 Wed, 16 Jan 2008 13:52:00 +0100 1155863 http://www.medworm.com/index.php?rid=1047610&cid=t_110558_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F189406329%2Ffda_approves_abilify_as_add-on_for_major_depression.html Earlier this month the U.S Food and Drug Administration approved Abilify for the treatment of schizophrenia in teens and have now expanded that approval to include patients with major depressive disorder.Approved in 2002 for schizophrenia in adults and for adults suffering from bipolar manic episodes, Bristol-Myers Squibb states that Abilify is the first drug approved as an adjunctive treatment for major depressive disorder for patients needing more than just antidepressants."The approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for their symptoms with antidepressants alone," commented Madhukar Trivedi, M.D., of the University of Texas Southwestern Medical School in Dallas.Supplemental approva... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1047610 Fri, 23 Nov 2007 15:00:13 +0100 1047610 http://www.medworm.com/index.php?rid=1040247&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F187797000%2F Why not? A holiday in the US may be nearing, but the work is piling up. What better way to recharge than to grab a cup of something hot and stare into your screen at the latest developments? And here they are… Biovail Gets Disappointing News From FDA; Stock Falls (Yahoo/AP) Ranbaxy Looks To Split R&D Unit, Buy A CRO (Economic Times) FDA OKs New Indication For Bristol’s Abilify (Yahoo/Reuters) Aegerion Pharma Refiles For IPO (Yahoo/AP) Barr Challenges Patents On ADHD Drugs (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1040247 Tue, 20 Nov 2007 16:55:58 +0100 1040247 http://www.medworm.com/index.php?rid=1036905&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F187192410%2Fatypical-antipsychotics-for-elderly.html A recent report in the St. Petersburg Times has indicated that between 20-26% of atypical antipsychotic prescriptions are for elderly people. The drugs are typically given in order to help calm patients. This is interesting because the data supporting their efficacy is very weak (1, 2, 3). While the article in the Times is interesting and discusses the problems with the drugs in terms of side effects, it, along with other media coverage with which I am familiar, is missing a major point: Atypical antipsychotics show minimal effects over the benefit given by a placebo. They are also linked to an increased risk of death. So you are increasing the odds of your patients dying, but you are, according to clinical trial research, providing minimal clinical benefit.Here's a shocking snippet from t... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1036905 Mon, 19 Nov 2007 14:32:00 +0100 1036905 http://www.medworm.com/index.php?rid=1030258&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185398220%2F A dreary, blustery day so far. But we are not swayed from enjoying the flow of interesting information coming our way. Whether you just finished that lengthy report or are preparing for that next meeting - oh, boy - we hope these will help ease your way…. Sanofi-Aventis Sued By Shareholders Over Acomplia Data (CNNMoney.com/Fortune) EU Approves Schering-Plough Hepatitis C Combo Therapy (Yahoo/AP) FDA Gives Priority Review To New Abilify Indication (Yahoo/AP) MedImmune Ventures Invests In Biotech (Washington Business Journal) Virginia Drug Monitoring Program Gets $20M From Purdue Deal (WCAV-TV) Abbott Senior VP Sells Stock (Yahoo/AP) Behind-The-Counter Sales Sparks Debate (Forbes/HealthDay News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1030258 Thu, 15 Nov 2007 20:22:09 +0100 1030258 http://www.medworm.com/index.php?rid=1021270&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F183668864%2Flatest-abilify-for-alzheimers-study-is.html This study claims that aripiprazole (Abilify) is safe and effective in treating Alzheimer’s patients who presented signs of psychosis. As I will demonstrate, anyone with an ounce of common sense and certainly anyone who passed a basic statistics course can see these claims (especially the claims regarding efficacy) are bordering on hilarious. Efficacy: Here’s what the authors said… Apripiprazole 10 mg/day was efficacious, and safe for psychosis associated with AD, significantly improving psychotic symptoms, agitation, and clinical global impression. Quickie stats lesson. In determining if there is a “statistically significant difference” between two groups, a large factor is the size of the sample. Just because a difference is “statistically significant” does not imply... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1021270 Mon, 12 Nov 2007 17:04:00 +0100 1021270 http://www.medworm.com/index.php?rid=1017641&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F182422377%2Fari-pimp-razole-science-and-marketing.html Wow. I've recently seen a study on aripiprazole (Abilify) that boggled my mind. It was in the category of godawful. I'll be writing more about it, likely within the next few days. Stay tuned. It goes to show that Bristol Myers Squibb will stop at nothing to market their product, but I suppose their recent large settlement for naughty marketing of Abilify already indicated they had no qualms in how they pimped their product.The atypical antipsychotics keep taking a beating on this site (1, 2) -- lots of hype for these medications treating, um, everything, yet little supporting data. (Source: Clinical Psychology and Psychiatry: A Closer Look) Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=1017641 Fri, 09 Nov 2007 22:47:00 +0100 1017641 http://www.medworm.com/index.php?rid=1009446&cid=t_110558_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F180742700%2Fabilify_fda_approved_for_teens.html Bristol-Myers Squibb (NYSE:BMY) announced that the U.S Food and Drug Administration has approved its drug Abilify for teens aged 13 - 17 that have been diagnosed with schizophrenia.Abilify (aripiprazole) is an antipsychotic drug that was first approved by the FDA at the end of 2002 for adults with schizophrenia and since that time Bristol-Myers says that more than 12.5 million US prescriptions for the drug have been written."We are extremely pleased that ABILIFY, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "ABILIFY® (aripiprazole) offers an effective new option to help... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1009446 Tue, 06 Nov 2007 20:30:44 +0100 1009446 http://www.medworm.com/index.php?rid=1007624&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180562258%2F The Bristol-Myers med can now be used for kids between ages 13 and 17. This is the second schizophrenia med that the agency has endorsed for youngsters. Earlier this year, the FDA approved Johnson & Johnson’s Risperdal for kids in the same age group, as well as for treating bipolar disorder for children between ages 10 and 17. The move comes after prolonged controversy over increased prescribing of antipsychotics for kids, despite a lack of FDA approval and studies indicating the meds are safe for youngsters. Bristol-Myers received the FDA nod based on results from a six-week, randomized, double-blind, placebo-controlled study that the drugmaker says demonstrated “significant improvement” compared to placebo on the primary efficacy endpoint, which measured symptoms. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1007624 Tue, 06 Nov 2007 13:30:23 +0100 1007624 http://www.medworm.com/index.php?rid=999551&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F178725568%2F Drugmakers aren’t the only ones, of course. But the Justice Department says it obtained $2 billion in settlements in fraud cases during fiscal year 2007, with most of the recoveries resulting from whistleblower lawsuits, the Associated Press reports. Approximately $1.45 billion of the settlements resulted from whistleblower lawsuits in fiscal year 2007, which ended Sept. 30, the department said. The individuals who filed suit were awarded $177 million. Under the False Claims Act, whistleblowers can sue companies or individuals that they believe have filed fraudulent claims with the federal government and, if successful, they can receive from 15 percent to 30 percent of the proceeds, the AP notes. Health care fraud accounted for most of the settlements, with $1.54 billion stemming fro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=999551 Fri, 02 Nov 2007 13:17:05 +0100 999551 http://www.medworm.com/index.php?rid=925267&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F164686932%2Fzyprexa-whitewash.html Furious Seasons has another tidbit from the Zyprexa documents. It involves the terms "diabetes" and "whitewash." You can read the internal Lilly document yourself at Furious Seasons and decide for yourself.If you've been living in a cave for the past 10 months or so, here are some other features regarding the infamous Zyprexa documents:Zyprexa: Off-Label Promotion?Demented Marketing of Zyprexa?Zyprexa: The New Mood Stabilizer and Downplaying RisksZyprexa: Off-Label Marketing Part 2And then there is Abilify. Read Brandweek NRX's piece here. Oh, and Seroquel? Read here and here. The lawsuits will keep coming, and there will be large payouts. I'm not a fan of suing the pants off everyone, but if there is no other way to fight off-label marketing and other dubious promotion tactics, then so be... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=925267 Wed, 03 Oct 2007 12:39:00 +0100 925267 http://www.medworm.com/index.php?rid=918018&cid=t_110558_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F163854743%2Fbristolmyers_squibb_settles_wi.html Bristol-Myers Squibb Co. (NYSE:BMY) and its subsidiary, Apothecon Inc. have agreed to pay over $515 million to settle civil suits over fraudulent marketing and pricing schemes.The federal suit included charges of illegally promoting the anti-psychotic drug Abilify to children and the elderly contrary to FDA approval. The agreement stated that Bristol-Myers Squibb gave kickbacks to doctors and other healthcare providers from 2000-20003 in to form of consulting fees and luxury trips with the intent of enticing them to prescribe the medication."Patients are entitled to unbiased decision-making from their physicians and should not have to worry that financial inducements or lavish entertainment have influenced their physicians' prescribing choices," said US Attorne... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=918018 Mon, 01 Oct 2007 20:19:57 +0100 918018 http://www.medworm.com/index.php?rid=917932&cid=t_110558_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F10%2Fbristol-myers-squibb-settles-enters.html And here we go again. Reported first late last Friday afternoon, as these things often are, was the huge settlement made by pharmaceutical manufacturer Bristol-Myers Squibb. This story received surprisingly little coverage in the main stream media, although World News Tonight (ABC) lead with it. The most detailed print version was in the Boston Globe,Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly, US Attorney Michael J. Sullivan said yesterday.The settlement between the federal government and Bristol-Myers Squibb and Apothecon Inc. is the third-largest between a pharmaceutical company and the US Attorney'... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=917932 Mon, 01 Oct 2007 15:56:00 +0100 917932 http://www.medworm.com/index.php?rid=912190&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162594831%2F The drugmaker agreed last December to settle charges of giving kickbacks to docs and overcharging the government, but now the bill has come due. And this includes signing a 5-year corporate integrity agreement. The US Attorney in Boston, Mike Sullivan, charged Bristol-Myers with illegally compensating docs to induce them to prescribe oncology meds between 2000 and 2003.. The kickbacks included consulting fees, advisory board payments and travel to “luxurious resorts.” And there’s more: The drugmaker’s Apothecon unit was charged with paying retailers and wholesalers to stock its drugs; there was off-label promotion of the Abilify schizophrenia drug for use in kids for dementia-related psychosis, and Bristol-Myers also misreported its best price for its Serzone antide... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=912190 Fri, 28 Sep 2007 19:48:45 +0100 912190 http://www.medworm.com/index.php?rid=904630&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161496555%2F That’s right. And it’s likely to occur because a senior FDA official overruled his colleagues. A three-member FDA team of medical reviewers initially urged rejecting Zyprexa for pediatric use because of inconsistent data from studies in US and Russian teens, Bloomberg News reports. But in an April 29 memo posted on the FDA’s Web site (look here), Thomas Laughren, head of the agency’s psychiatry division, wrote that the drug’s benefits in some studies outweighed the reviewers’ concerns. Zyprexa, with $4.4 billion in global sales in 2006, is Lilly’s biggest seller and the biggest among five antipsychotics. But the teen market is important to Lilly, because Zyprexa’s market share has slipped as 86 percent of psychiatrists are writing fewer scri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=904630 Wed, 26 Sep 2007 12:06:24 +0100 904630 http://www.medworm.com/index.php?rid=882993&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158224083%2F That’s right. The antipsychotic, as you know, can cause weight gain and diabetes. And a survey conducted last month finds that 86 percent of psychiatrists are now writing fewer scrips for Zyprexa. They cited the side effects as the reason, according to Sandra Chow, an analyst at Decision Resources, the market-research firm that queried 151 docs. “Zyprexa, you know, dominated the schizophrenia market just two years ago. In fact, Zyprexa was the number one choice for first-line, second-line and third-line treatment a couple of years ago,” Chow tells Pharmalot. “But the side effects have really changed the perception.” The fall from grace follows a year in which litigation documents were leaked indicating Lilly allegedly hid side-effect data from docs, and sever... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=882993 Tue, 18 Sep 2007 19:57:51 +0100 882993 http://www.medworm.com/index.php?rid=841907&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F152451613%2F That’s what the rate of scrips for antipsychotics written for kids is being called in the wake of a study this week in the Archives of General Psychiatry. The research showed that there’s been a 40-fold increase over nine years in the number of kids diagnosed with bipolar disorder, fueling an explosion in sales of antipsychotic meds made by Johnson & Johnson, AstraZeneca and Pfizer. The number of scrips written for kids doubled to 4.4 million between 2003 and 2006, according to data provided to Bloomberg New by Wolters Kluwer, a research firm. The expanded use of bipolar disorder as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion US market for antipsychotic drugs. Some experts say the treatments are bringing needed help to troubled kid... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=841907 Wed, 05 Sep 2007 10:57:53 +0100 841907 http://www.medworm.com/index.php?rid=840787&cid=t_110558_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F152076613%2F The number of American children diagnosed with bipolar disorder jumped 40-fold from 1994 to 2003, according to a study in the Archives of General Psychiatry (here’s the abstract). By 2003, the diagnosis was applied to 1 in 100 kids, researchers found. Of the 800,000 people ages 19 and younger with the diagnosis, 91 percent were treated with at least one drug and two-thirds with two or more, Bloomberg News reports. Adult diagnoses almost doubled to 1,069 for each 100,000 people, and the rate among kids reached 1,003. Drugs used to treat the disorder, including Johnson & Johnson’s top-selling Risperdal, are linked to side effects including weight gain and diabetes, the researchers said. Patients treated for a condition they don’t have won’t respond to the treat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=840787 Tue, 04 Sep 2007 14:38:11 +0100 840787 http://www.medworm.com/index.php?rid=752802&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F136729834%2Fmore-science.html During my semi-hiatus, which has been far from recreational, I have mostly kept up with my reading (but obviously not writing). Of particular note to psychiatry, marketing, and pseudoscience, check out a couple great posts from Dr. Daniel Carlat.One is about an incredibly bogus "survey" that turns up favorable results for Abilify. Oh, how I LOVE that the "science" is stacking up behind Abilify these days.The other is regarding the alleged (and fake) hidden epidemic of ADHD among depression patients.There are many other good posts that I've not the time to cover now. (Source: Clinical Psychology and Psychiatry: A Closer Look) Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=752802 Tue, 24 Jul 2007 04:26:00 +0100 752802 http://www.medworm.com/index.php?rid=742590&cid=t_110558_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F134948506%2Fabilify-its-tricky-to-rock-fda.html In the "you're kidding me" category, we have a report from Forbes that Abilify (aripiprazole) is going to be going up for FDA priority review as a depression treatment. I was able to track down exactly one placebo-controlled study using this drug as an antidepressant. Participants who did not show satisfactory response to an antidepressant trial were assigned to receive either Abilify or a placebo in addition to their antidepressant. As you'll see, this was a study worthy of close examination.Study Results. I read the study results and was underwhelmed. The authors (via their ghostwriter(s) to some unknown extent) reported that the difference between those receiving add-on Abilify vs. add-on placebo was three points on the Montgomery-Asberg Depression Rating Scale (MADRS). For perspective,... Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=742590 Wed, 18 Jul 2007 13:47:00 +0100 742590