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 'forest'. Sat, 03 Sep 2011 02:01:43 +0100 http://www.medworm.com/index.php?rid=5125969&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP452Yvu9Hlk%2F And so yet another working week will soon draw to a close. Not a moment to soon, yes? This is, of course, our treasured signal to daydream about weekend plans. Our own agenda includes taking one of the short people to a soccer match, catching up on some reading and tidying up around the Pharmalot corporate campus. In other words, a few small pleasures. And what about you? How about a day at the beach or a ride in the country? Maybe curl up with an e-book? Or a shopping trip to stimulate what is left of the economy? Whatever you do, have a grand time, and be safe. See you soon… US Ambassador Tells Czechs Not To Auction Meds Online (Prague Daily Monitor) Icahn Wants To Narrow Forest’s Research Focus (Bloomberg News) MannKind Claims To Have Clear Path Forward On Afrezza (Pharma Ti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5125969 Fri, 12 Aug 2011 12:09:49 +0100 5125969 http://www.medworm.com/index.php?rid=5107457&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F08%2Fretreat-back-to-regulatory-capture-us.html After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs.Weakening FDA Conflict of Interest RulesAs reported by Reuters,U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.This was not purely an initiative of legislators, but was egged on by a top FDA administratorThe agency often must delay panel meetings while i... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5107457 Mon, 08 Aug 2011 17:13:00 +0100 5107457 http://www.medworm.com/index.php?rid=5103514&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHhaDzWm8_2c%2F After months of mystery, the US Department of Health & Human Services has decided not to exclude Forest Laboratories ceo Howard Solomon from doing business with federal healthcare programs, such as Medicare and Medicaid. The move came four months after the HHS Office of Inspector General shocked the drugmaker with its plan to ban the 83-year-old executive. “Based on a review of the information in our file and consideration of the information that your attorneys provided to us, both in writing and during an in-person meeting, we have decided to close this case. We anticipate no further action related to this matter,” Peter Clark, the OIG exclusions director wrote in a letter to Solomon this afternoon (here is the letter). Last September, Forest made a $313 million payment that incl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5103514 Fri, 05 Aug 2011 22:32:59 +0100 5103514 http://www.medworm.com/index.php?rid=5103515&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQz_vdwe68UQ%2F In its quest to exclude Forest Laboratories ceo Howard Solomon from doing business with federal healthcare programs, the US Department of Health & Human Services had also considered banning seven other Forest executives, but ultimately decided not to do so as negotiations were held last fall to settle charges of illegal marketing (back story), according to court documents that were released today. The disclosure prompted another round of criticism from investor Carl Icahn (see pic), who is waging a proxy fight to win four of 10 board seats at the August 18 annual shareholder meeting (see this). “That means nearly one year ago, Forest was faced with a threat to the continuity of its management team and today still has not disclosed a viable, or even any, succession plan,” a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5103515 Fri, 05 Aug 2011 21:28:04 +0100 5103515 http://www.medworm.com/index.php?rid=5078031&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFHoLk-8rWDc%2F With the annual Forest Laboratories shareholder meeting just three weeks away, the AFL-CIO is urging shareholders to vote ceo and president Howard Solomon right off the board. The move is in response to the recent disclosure that Solomon faces being excluded from participating in federal healthcare programs by the US Department of Health and Human Services Office of the Inspector General. The feds took that step not long after a subsidiary, Forest Pharmaceuticals, pleaded guilty to obstruction of justice, distributing an unapproved drug and illegally promoting two other meds. As part of its deal, Forest made a $313 million payment that included $164 million in criminal penalties, and signed a corporate integrity agreement (see here). Forest argues that Solomon was not involved and, therefo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078031 Fri, 29 Jul 2011 13:21:58 +0100 5078031 http://www.medworm.com/index.php?rid=5077693&cid=t_112077_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffootball-helmets-which-ones-are-most-likely-to-prevent-head-injuries%2F2011.07.28 Courtesy of Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences: National Impact Database Adult Football Helmet Ratings – May 2011 A total of 10 adult football helmet models were evaluated using the STAR evaluation system for May 2011 release.  All 10 are publicly available at the time of publication.  Helmets with lower STAR values provide a reduction in concussion risk compared to helmets with higher STAR values.  Based on this, the best overall rating of ‘5 Stars’ has the lowest STAR value.  Group rankings are differentiated by statistical significance. If you’re in the market to buy a loved one a football helmet, or just curious, go and have a look. It doesn’t take long, there are only 10 helmets on the list. Go to the list. I got to this from ESPN’... Better Health blogs http://www.medworm.com/rss/comments.php?id=5077693 Thu, 28 Jul 2011 12:00:20 +0100 5077693 http://www.medworm.com/index.php?rid=5051233&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_Ne7ygGc-0w%2F Faced with being banned from doing business with such federal healthcare programs as Medicare and Medicaid, Forest Laboratories ceo and president Howard Solomon recently retained former US Senator John Breaux as a lobbyist. The Louisiana pol is now a senior counsel with the Patton Boggs law firm, which has a large healthcare practice (see here). His lobbying registration form was filed on June 14, two months after the Office of Inspector General of the US Department of Health & Human Services notified the drugmaker that its 83-year-old executive was facing exclusion (read this). The Hill first reported Forest hired Breaux. Last year, Forest pleaded guilty to obstruction of justice and made a $313 million payment that included $164 million in criminal penalties, and signed a corporate ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051233 Fri, 22 Jul 2011 14:48:51 +0100 5051233 http://www.medworm.com/index.php?rid=5050461&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F07%2Fhealth-care-for-very-rich-is-different.html Another glimpse of health care for the very rich comes by way of a BNet post by Jim Edwards about the beleaguered CEO of Forest Laboratories.The background is that:The CEO is fighting to retain his place atop the company against both investor Carl Icahn, who wants his own directors on Forest’s board, and the Department of Health & Human Services, which wants to exclude Solomon from the drug business as a punishment for the company settling a $313 million investigation by the Department of Justice over its illegal marketing of Levothroid and other drugs.We had posted about the government threat to disbar him from government business after his company here. Edwards noted that despite these setbacks, Solomon's total compensation actually increased:Forest Labs (FRX) reported that CEO How... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5050461 Tue, 19 Jul 2011 21:16:00 +0100 5050461 http://www.medworm.com/index.php?rid=5036278&cid=t_112077_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F07%2F16%2Fexpectation-affects-our-food-likes-and-dislikes%2F What is expectation assimilation? It’s the notion that our taste perceptions are biased by our imagination, and if you expect a food to taste good it will.  However, expectation assimilation also works in the opposite direction.  If you expect a food to taste unpleasant it will (Wansink, 2006). At a cafeteria in Urbana, Illinois, 175 people were given a free brownie dusted with powdered sugar (Wansink, 2006).  They were told the brownie was a new dessert that may be added to the menu.  They were asked how they liked the flavor and how much they would pay for it.   All of the brownies were the same size and had the same ingredients.  However, the brownies were served on a china plate, on a paper plate or on a paper napkin. Those who received the brownie on a china plate said t... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5036278 Sat, 16 Jul 2011 10:28:53 +0100 5036278 http://www.medworm.com/index.php?rid=4984689&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEygW_voyKzU%2F Rise and shine. Another glorious day is unfolding here on the Pharmalot corporate campus, where we are moving along like a cool breeze. Of course, there is much to be done - phone calls, meetings, reading documents. You name it. And we know you can related. So grab that cup of stimulation - no excuses, please - and pick up your to-do list. Meanwhile, here are some tidbits from around your world. Have a good one… US Court Orders Seizure Of Cipla Pet Drug For Patent Violation (Dow Jones) Lilly Plans 10 Drug In Final-Stage Trials By End Of 2011 (Bloomberg News) Niaspan Prescriptions Fall After Negative Study Results (Dow Jones) Pfizer Signs Deal With Russian Venture Capital Firm For R&D (Associated Press) Forest Files COPD Drug For FDA Approval (Pharma Times) ‘Neurontin Kille... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984689 Thu, 30 Jun 2011 11:53:38 +0100 4984689 http://www.medworm.com/index.php?rid=4976204&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2jyWx_FI6TU%2F Now that Carl Icahn has scooped up nearly 7 percent of Forest Laboratories stock and wants to place four of his minions on the board (back story), Wall Street is eyeing the drugmaker as takeover bait. The premise is helped along by the fact that Forest has five newer products, including three that will be launched by September, and another four in the pipeline that, when taken together, could add up to an attractive package. To wit, these nine drugs have the potential to dramatically boost earnings over the next five years, according to an investor note from Credit Suisse analyst Catherine Arnold. In her view, a mere 5 percent rise in 2016 sales implies a 24 percent earnings gain. This is particularly important since the Lexapro antidepressant, which generated 53 percent of 2011 sales, los... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976204 Tue, 28 Jun 2011 12:57:12 +0100 4976204 http://www.medworm.com/index.php?rid=4918499&cid=t_112077_46_f&fid=38787&url=http%3A%2F%2Fmsf.ca%2Fblogs%2Fphotos%2F2011%2F06%2F10%2Fliberia-4%2F May 14, 2011 Cutting trees in order to expand a refugee camp in Liberia. Over 100,000 people fled post-election violence in Ivory Coast. In places like Nimba county, Liberia the majority of refugees have not travelled to camps, but seek shelter with host families in dispersed villages near the border. Out of fear, many in Ivory Coast still remain in hiding in the bush in the border region. (Source: MSF Blogs) MSF Blogs blogs http://www.medworm.com/rss/comments.php?id=4918499 Fri, 10 Jun 2011 08:10:02 +0100 4918499 http://www.medworm.com/index.php?rid=4862467&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Fmillion-dollar-plus-hospital-ceo.html Health care leaders' compensation has again been in the news. Below are highlights from stories about four medical centers, emphasizing the magnitude of executive compensation, how it is related, or not to hospital and executive performance, and whether and how the organizations' boards chose to justify it. The medical centers are in alphabetical order. University of Pittsburgh Medical CenterCompensationAccording to the Pittsburgh Post-Gazette:In tax documents released Friday, Jeffrey Romoff, president and CEO of the University of Pittsburgh Medical Center, received $4.01 million in salary, bonuses and benefits that year.Also,Other top earners at UPMC include neurosurgeons Ghassan Bejjani, $2.37 million in salary and benefits, and Richard Spiro, $2.23 million; cardiothoracic surgeon James ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4862467 Wed, 25 May 2011 18:31:00 +0100 4862467 http://www.medworm.com/index.php?rid=4813213&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Flogical-fallacies-to-defend-ceos-from.html There is now quite a kerfuffle over the US Department of Health and Human Service's threat to to stop doing business with the CEO of Forest Laboratories.  As we noted here, his company pleaded guilty to obstruction of justice and misbranding, and agreed to pay a $313 million fine.  The major allegations by the government were that the company marketed antidepressants to children when they had only previously been approved for adults. Their marketing tactics allegedly included suppressing negative studies, and paying physicians to prescribe the drugs. The kerfuffle involves a number of ostensible authorities and pundits defending the CEO, and challenging the government's attempts to hold him responsible for his company's actions.  The kerfuffle also provid... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4813213 Tue, 10 May 2011 22:22:00 +0100 4813213 http://www.medworm.com/index.php?rid=4803526&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F523l9y18j4A%2F The legal problems are piling up at Forest Laboratories. The drugmaker has just disclosed that a subpoena arrived from the US Attorney in Boston seeking documents relating to the marketing of the Benicar, Benicar HCT and Azor high blood pressure meds. Forest and Daiichi Sankyo, which developed the drugs, jointly promoted the pills from 2002 to 2008, according to a Forest statement. The subpoena was dated April 20, just about the same time, as it so happens, that Forest ceo and president Howard Solomon was unexpectedly informed by the US Department of Health and Human Services Office of the Inspector General that he faces being excluded from participating in federal healthcare programs (back story). That move came six months after the drugmaker pleaded guilty to obstruction of justice, dist... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803526 Mon, 09 May 2011 20:24:42 +0100 4803526 http://www.medworm.com/index.php?rid=4753630&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fwill-pharmaceutical-ceo-finally-be-held.html It appears there may be a move afoot to have the leader of a large health organization suffer some negative consequences for the misbehavior of his organization.  As reported by the St Louis Post-Dispatch,For the past 34 years, Howard Solomon has presided over Forest Laboratories Inc., a midsize pharmaceutical company that runs its national sales operations from Earth City.Solomon, 83, took home $8.3 million last year as the company's chairman, president and chief executive officer. But his company's marketing arm also fell into trouble, pleading guilty to federal charges that its sales force illegally marketed the antidepressants Celexa and Lexapro to children and adolescents, even though these drugs had not been approved for minors.Now, the federal Department of Health and Huma... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4753630 Mon, 25 Apr 2011 19:25:00 +0100 4753630 http://www.medworm.com/index.php?rid=4600537&cid=t_112077_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fregenerative-medicine-and-printing-human-tissue%2F2011.03.16 Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine (WFIRM) at Wake Forest University School of Medicine, returned to TED 2011 a couple weeks ago to give updates on his breakthroughs in regenerative medicine. In addition to explaining the process of growing bioengineered organs, valves, and tissues, he also demonstrates how he’s using printing technology to fabricate body parts and even print skin tissue directly onto a patient’s wound. Other highlights of the talk include a live demo of a kidney-shaped mold being printed on the TED stage, and a reunion with a young patient who was one of the first recipients of a bioengineered bladder from Dr. Atala’s lab. Be sure to also check out Dr. Atala’s talk from TEDMED 2009… Additional... Better Health blogs http://www.medworm.com/rss/comments.php?id=4600537 Wed, 16 Mar 2011 15:00:08 +0100 4600537 http://www.medworm.com/index.php?rid=4549709&cid=t_112077_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2011%2F03%2Fwake-forest-scientists-attempt-manufacture-kidney-tissue-printing%2F Scientists from the Wake Forest Institute of Regenerative Medicine are attempting to build a new kidney through a process similar to printing layers of cells onto each other much like a printer places ink on a page. The effort is being led by Anthony Atala. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=4549709 Sat, 05 Mar 2011 02:12:12 +0100 4549709 http://www.medworm.com/index.php?rid=4532570&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8IsrwzAqM_A%2F Top of the morning to you. A sunny day is unfolding here on the Pharmalot corporate campus, where we are, once again, hustling short people off to this or that school house. Nonetheless, we are also reaching for our mandatory cup of stimulation - our flavor today is Cinnamon Cream Swirl - and looking about for interesting items. Please let us know if you spot something yourself. Meanwhile, have a great day… Daiichi To Buy Plexxicon For Up To $935M (Bloomberg News) Pharma Job Outlook Bleak In Europe As Sites Are Closed (Reuters) Forest And Nycomed Win FDA Approval For COPD Drug (Associated Press) Elan Pleads Guilty In Zonegran Marketing (Boston Business Journal) Feds Award $215M For Flu Vaccine Development (Associated Press) UK’s NICE Wants More Data On Roche Cancer Drug (Dow Jo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532570 Tue, 01 Mar 2011 13:02:23 +0100 4532570 http://www.medworm.com/index.php?rid=4220458&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7L5bE1wLCDc%2F Maybe GlaxoSmithKline sales reps deserve a bonus. A new survey of more than 1,800 primary care physicians ranked the drugmaker’s field force as the best, even as sales calls to these docs - which include general practitioners, family med physicians and doctors of osteopathy - fell 12 percent in the 12 months ending September 2010, compared with the previous 12-month period. On a score of 1 to 7, Glaxo’s average quality score was 5.71, up from 5.54 in 2009, according to SDI Health, a market research firm that conducted the survey. The showing catapulted Glaxo from third place last year, when the drugmaker followed Pfizer and Merck, both of which moved down a notch from the No. 1 and No. 2 slots, respectively. On a related note, in both years, 97 percent of the docs indicated they w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220458 Wed, 01 Dec 2010 13:01:57 +0100 4220458 http://www.medworm.com/index.php?rid=4106063&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKtFErbiCVU8%2F There have been numerous headlines lately about healthcare fraud and whistleblowers whose lawsuits eventually prompted huge settlements with the federal government. The latest tally, however, shows that the US Department of Justice recovered over $3.1 billion in fraudulent claims in the 2010 fiscal year that can be traced to lawsuits filed under the federal False Claims Act. Specifically, there were 145 FCA cases settled in the 2010 fiscal year and the 10 largest settlements involved health care fraud, with eight involving drugmakers, according to Taxpayers Against Fraud, a non-profit that supports whistleblower lawsuits. The 10 largest cases accounted for $2.7 billion recovered. Although fiscal year 2009 actually recovered a larger pot of money - $5.6 billion. It also worth that health ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106063 Mon, 25 Oct 2010 12:32:03 +0100 4106063 http://www.medworm.com/index.php?rid=4018441&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaK3IEXLaIa8%2F Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers, while $185 million goes toward criminal penalties. One of the lawsuits was filed by Jeremy Garrity, a former cardiovascular sales rep, who worked for Novartis between 2002 and 2008 before being fired (you can read it here, and you can read the settlement here. Oh, and this is the guilty plea). This is the latest in a stream of settlements involving bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018441 Thu, 30 Sep 2010 17:26:16 +0100 4018441 http://www.medworm.com/index.php?rid=4003434&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYWhwlZl3PU%2F Earlier this year, a former Pfizer exec amended his whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare. Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans, the suit charges. And in a newly filed brie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003434 Mon, 27 Sep 2010 15:28:45 +0100 4003434 http://www.medworm.com/index.php?rid=3980796&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F09%2Fforest-pharmaceuticals-pleads-guilty-to.html The parade of legal settlements marches on.  The latest story is about Forest Laboratories and its marketing of Celexa (citalopram ) and Levothyroid (l-thyroxin).  Here is the most complete version, courtesy of Natasha Singer reporting for the New York Times. First, the lead sentence:A unit of Forest Laboratories, the maker of the antidepressant Celexa, agreed on Wednesday to pay more than $313 million to settle criminal and civil complaints, including a claim that it had illegally promoted the drug for use in children. Here are the charges:Among the criminal charges was one that the subsidiary, Forest Pharmaceuticals, marketed Celexa, which was approved only for adult depression, to treat children and adolescents. The government also claimed that, in conjunction with the company... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3980796 Fri, 17 Sep 2010 19:27:00 +0100 3980796 http://www.medworm.com/index.php?rid=3973109&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fcg69u3pOB2o%2F Another week, another guilty plea by a drugmaker charged with illegal promotion. This time around, Forest Labs has pleaded guilty to obstruction of justice, distributing an unapproved drug and illegally promoting two other meds (see the plea agreement). The drugs in quetion were Levothroid, an oral med for thyroid conditions, and two antidepressants - Celexa and Lexapro. The $313 million payment includes $164 million in criminal penalties. Forest was charged with distributing Levothroid in the early 1990s without obtaining FDA approval. This particular tale is complicated - this type of drug was around for decades, but in 1997, the FDA declared these were now considered new meds (look here). This meant approval was required, but since these are medically necessary, an extension was granted... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973109 Wed, 15 Sep 2010 20:14:54 +0100 3973109 http://www.medworm.com/index.php?rid=3965697&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCSt3qKYXFWs%2F Top of the morning to you. We are scurrying about in hopes of depositing one of the short people at the local schoolhouse. As always, this requires fortitude and a cup of stimulation. Meanwhile, we would like to remind you that we will host a webinar today (see this) with former US Attorney Mike Loucks about brand promotion compliance. And now, let the day begin. Have a good one, everyone… Forest Labs Responds To FDA For COPD Drug (Pharma Times) Pfizer Sees A Turnaround For Its Labs (Reuters) Sanofi May Boost Genzyme Bid As Lab Unit Is Sold (Bloomberg News) Counterfeit Drug Tally Is Hard To Swallow (Wall Street Journal) Gilead Quad Pills Supresses HIV At 48 Weeks (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965697 Tue, 14 Sep 2010 11:49:31 +0100 3965697 http://www.medworm.com/index.php?rid=3784501&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIc5cj0KKC-k%2F And so another work week soons draw to a close. A respite, of course, is always welcome. Already, we look forward to spending time with our oh-so-busy short people, catching up on reading and promenading with the official Pharmalot mascots. And you? How will you keep cool? We trust you have some ideas in mind. While you ponder, here are the latest tidbits. Whatever you do, have a great time and see you soon… Gene Curtails Alzheimer’s In Mice (The Wall Street Journal) Pittsburgh Doctors And Pharma Money (Pittsburgh Business Times) EU Needs More Time To Review Avandia (PharmaTimes) GAO Finds Consumer Gene Tests Are Misleading (Reuters) Lilly Pushes Into Men’s Health Drug (The Indianapolis Star) Negative Clinical Studies Could Avoid Costly Treatments (The Washington Post) Fe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3784501 Fri, 23 Jul 2010 11:52:38 +0100 3784501 http://www.medworm.com/index.php?rid=3757829&cid=t_112077_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fvacation-in-nature-%25e2%2580%2594-literally-treehotel%2F If you happen to be traveling to Sweden this summer, and enjoy — I don’t know — having your mind blown, then you’ll need to check out Treehotel. Opening on Saturday, Treehotel consists of four rooms, each in a separate, unique building suspended in the canopy of the Boreal forest. Though only one of the rooms is mirrored (much to our and Double Rainbow Guy’s dismay), all of the rooms will offer breathtaking views of the forest surrounding them. The hotel also offers year-round activities, but none that hurt the environment. We are definitely putting Treehotel on our fantasy to-do list. Check out the other three rooms on Inhabitat. photo from Inhabitat via Inhabitat Post from: BlissTree Vacation in Nature — Literally: Treehotel (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3757829 Thu, 15 Jul 2010 21:53:15 +0100 3757829 http://www.medworm.com/index.php?rid=3718695&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3564199&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPSiRUKFcokE%2F Besides simply selling pills at a profit, Forest Labs appears to engage in what’s known as transfer pricing - a highly complicated way of avoiding taxes by creating overseas subsidiaries that, in Forest’s case, are used to hold patents and facilitate transactions out of reach of the US Treasury. To illustrate the complexities, Bloomberg News attempted to follow the mysterious trail of dollars generated by Lexapro, Forest’s wildly popular antidepressant, an effort that involved visiting not only a manufacturing plant in Ireland, where tax rates are lower, but also revealed subsidiaries in Bermuda and The Netherlands that appear to function merely as convenient shells. By playing the avoidance game, Forest cut its US tax bill by more than one-third last year and various in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3564199 Fri, 14 May 2010 13:11:26 +0100 3564199 http://www.medworm.com/index.php?rid=3515298&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F04%2Foh-prices-we-pay-reloaded-celgene-balks.html A brief article on Bloomberg.com implied that Celgene has been fighting efforts by the Canadian Patented Medicine Prices Review Board to get pricing data about the drug Thalidomid (thalidomide):Celgene Corp., the biotechnology company specializing in blood-cancer medicines, will get a hearing before Canada’s highest court over the country’s demands to provide pricing information for the drug Thalomid.The Supreme Court of Canada today agreed to hear Celgene’s appeal of a Federal Court of Appeal ruling that said Canada’s Patented Medicine Prices Review Board was entitled to information about the pricing of the drug. The high court gave no reason for its decision.Celgene’s two top-selling drugs are Revlimid and Thalomid, for a form of blood-cancer called multiple myeloma. They broug... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3515298 Wed, 28 Apr 2010 19:57:00 +0100 3515298 http://www.medworm.com/index.php?rid=3486996&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F04%2Fanother-echo-of-case-of-deadly-heparin.html In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below.Case Summary- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infus... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3486996 Mon, 19 Apr 2010 20:53:00 +0100 3486996 http://www.medworm.com/index.php?rid=3460142&cid=t_112077_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Ffinal-best-of-blisstree-last-week-then-well-stop-bragging-we-swear%2F Renée Zellweger in "My Own Love Song" 1. Let’s Dress Like an Adult! (Round 2): Because sometimes the truth hurts. 2. 5 iPad Cases With an Eco-Conscience: Because we haven’t bought an iPad (yet), but we like to know what our accessories options are. 3. Videos That Crack Us Up: Renée Zellweger Butchers Woody Guthrie: Because at some point today you may need a good laugh. 4. Who Am I, Anyway? Adoption, DNA Testing, and Figuring Myself Out: Because this is a good story by a good writer. 5. Yucky! 10 More Food-Related Terms We Will Not Tolerate: Because we said so. Post from: BlissTree Final Best of Blisstree Last Week (Then We'll Stop Bragging, We Swear) (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3460142 Sun, 11 Apr 2010 19:31:20 +0100 3460142 http://www.medworm.com/index.php?rid=3449142&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8IAtaF2hX74%2F Another day, another deadline. It is an old axiom in our line of work, but most likely, just as pertinent in yours, as well. And so as we brew another cup of stimulation to greet the day, here are a few items to help you along. Have a great day, everyone… Carlyle Hires Former Wyeth CEO Essner As Advisor (Wall Street Journal) PhRMA Taps AstraZeneca VP For Transition (PR Week) Former Lawyer Who Bilked Wyeth Wants Conviction Tossed (WREG) Pfizer To Boost Clinical Trials In Singapore (ChannelNewsAsia) Contentious Patents Granted Big Pharma In India (LiveMint) FDA Warns Gilead & Biogen Over Drug Ads (Reuters) FDA Panel Rejects Forest Lung Disease Drug (Associated Press) P&G Breached UK Ethics Code (Cincinnati Business Courier) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3449142 Thu, 08 Apr 2010 12:28:08 +0100 3449142 http://www.medworm.com/index.php?rid=3443979&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6LFPWDyWU_s%2F Industry spending on marketing to Vermont doctors and hospitals totaled $2.6 million in the 12 months ending July 1, 2009, which is when a new law took effect that is designed to reduce the flow of dollars, according to a report from Vermont attorney general William Sorrell. The spending, which was racked up by 85 drugmakers, was about $400,000 less than the previous years. The biggest spenders were Lilly, Pfizer, Forest Labs, Merck and GlaxoSmithKline. “They’re going down, and they’ve been going down for a few years,” Sorrell tells Bloomberg News. “The question is whether their disclosure obligations are having an impact on that or whether they’re just changing their marketing strategies.” The total dollars paid to doctors who individually receive... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3443979 Wed, 07 Apr 2010 12:56:17 +0100 3443979 http://www.medworm.com/index.php?rid=3433164&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc_0pliKPa0w%2F The Federal Aviation Administration has dropped a decades-old ban on four antidepressants and so, as of April 5, as many as 10,000 pilots - some of whom were grounded - will be allowed to take to the air while on Prozac, Pfizer’s Zoloft or Forest Lab’s Celexa and Lexapro, Bloomberg News reports. In reaching its decision, the FAA says that drowsiness, which is associated the pills, doesn’t pose a safety threat. “We have a better understanding of the drugs,” FAA Administrator Randy Babbitt tells the news service. “We know more about the illness, we know more about how to treat it. We really need to remove the stigma, if you will, of being treated for an illness.” FAA policy bans pilots from flying if depressed because the condition can be distracting in the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3433164 Fri, 02 Apr 2010 12:20:39 +0100 3433164 http://www.medworm.com/index.php?rid=3194020&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVZLb8OwMT6s%2F Which one? Public Citizen says the agency should yank Savella immediately because its dangers outweigh its benefits, according to a petition the consumer group sent the agency. In its missive, Public Citizen notes the European Medicines Agency rejected the drug for fibromyalgia last July, citing marginal benefits that failed to outweigh risks. The FDA approved the drug in January 2009. In two randomized clinical trials, Savella, which is made by Forest Labs and Cypress Bioscience, was found to increase blood pressure, heart rate and suicidal thoughts, according to the petition. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those given Savella developed hypertension, compared to 7.2 percent of those on a placebo. Based on the extent of increas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3194020 Wed, 20 Jan 2010 22:47:05 +0100 3194020 http://www.medworm.com/index.php?rid=3164046&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FipITQPUrxU8%2F Morning, everyone. Nice to see you again. A busy week, yes? But that’s to be expected in January, when conferences and earnings are omnipresent. With so much to do, we hope you have time to stop for a cup of something stimulating now and then, and of course, to catch up on events. Here are a few items to help you along… Dendreon Sees Full Provenge Capacity By Mid-2011 (Reuters) EU Steps Up Antitrust Probe (Bloomberg News) FDA Rejects Wider Use Of Forest Drug (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3164046 Tue, 12 Jan 2010 12:47:19 +0100 3164046 http://www.medworm.com/index.php?rid=2977572&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwkVkB9o9ZEw%2F The drugmaker reached a tentative settlement with the US Attorney in Boston and the US Department of Justice’s, which charged that its antidepressants and a thyroid drug were marketed improperly. However, a criminal probe continues, according to a filing with the Securities and Exchange Commission (see page 15). As it turns, an agreement in principle was reached in May concerning the civil investigation being conducted by federal and state authorities. The penalties are covered by a $170 million reserve Forest created in April. But the arrangement “does not resolve the government’s ongoing investigation into potential criminal law violations” related to the Celexa and Lexapro antidepressants, as well as the Levothroid thyroid drug. In February, the U.S. Justice Dep... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977572 Mon, 09 Nov 2009 23:00:10 +0100 2977572 http://www.medworm.com/index.php?rid=2832359&cid=t_112077_134_f&fid=35187&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDiabetesDaily%2F%7E3%2FREb1ujS141E%2Fthe-enchanted-broccoli-forest.php This dish is one that evokes many childhood memories for me.  My mom used to make this for us when I was younger and last night, I made it for the first time for my daughter.  It was just as I remembered it- flavorful and so fun to make and look at.  Leah, David and I loved it.  It was so great for me to watch Leah eating something that I used to eat as a child.  The Enchanted Broccoli Forest is the recipe that the cookbook is named after.  It's a herbed rice pilaf that has broccoli florets coming up out of it.  If you have kids (or anyone) who doesn't like to eat broccoli, this is a great way to get them to.  How fun is food that looks like a forest?  It's not low carb- it's mostly rice.  But if you have room in your diet for some carbs, t... Diabetes Daily blogs http://www.medworm.com/rss/comments.php?id=2832359 Fri, 25 Sep 2009 12:00:00 +0100 2832359 http://www.medworm.com/index.php?rid=2824384&cid=t_112077_134_f&fid=35187&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDiabetesDaily%2F%7E3%2FFOHRErPs-jE%2Fenchiladas.php I used to live in Colorado and the Mexican food there is to die for.  When I moved back to Cleveland a few years ago, I had no idea how poor of a selection of good Mexican restaurants exist here.  There are none.  When I found recipes for enchiladas in my Enchanted Broccoli Forest cookbook, I was excited to try them out.  I had never tried to make enchiladas before, but the instructions looked fairly simple and the sauces seemed really delicious.  There are two different sauces that you can make.  One is a spicy salsa verde and the other is a full-flavored red sauce with tomatoes and red bell pepper.  I was really excited because I had some green tomatoes in the garden that I used up to make the salsa verde and a whole bunch of cherry tomatoes that I used... Diabetes Daily blogs http://www.medworm.com/rss/comments.php?id=2824384 Wed, 23 Sep 2009 12:00:00 +0100 2824384 http://www.medworm.com/index.php?rid=2814638&cid=t_112077_134_f&fid=35187&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDiabetesDaily%2F%7E3%2FXq3PfF3W0ao%2Fenchanted-broccoli-forest-cookbook-winner.php I was so excited to see how many comments everyone left for the Enchanted Broccoli Forest cookbook giveaway!  Unfortunately, I can only pick one of you.  Jollymon, one of our forum members and loyal Simply Cooking commenter, won our giveaway!  How do we pick our winners?  If you go to this link here, you'll see that we have a random number generator.  The commenter whose number shows up first, wins!Keep your eyes out for our next giveaway.  You could be the lucky winner!  Read more at Diabetes Daily! (Source: Diabetes Daily) Diabetes Daily blogs http://www.medworm.com/rss/comments.php?id=2814638 Mon, 21 Sep 2009 01:38:41 +0100 2814638 http://www.medworm.com/index.php?rid=2807834&cid=t_112077_134_f&fid=35187&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDiabetesDaily%2F%7E3%2FgzdHZa--eJI%2Fgiveaway-the-enchanted-broccoli-forest-cookbook.php One of my favorite cookbooks of all time, The Enchanted Broccoli Forest by Mollie Katzen is a must-have on your cookbook shelf.  I grew up with this cookbook and can say that every recipe that I've made out of it is delicious... and healthy!Do you want a copy of The Enchanted Broccoli Forest?  If you do, leave a comment below (real email addresses, please- it won't be published).  We'll select a commenter randomly!This contest is open to US residents only and will end at the end of the day on Sunday, September 20th.  Good luck! Read more at Diabetes Daily! (Source: Diabetes Daily) Diabetes Daily blogs http://www.medworm.com/rss/comments.php?id=2807834 Fri, 18 Sep 2009 12:00:00 +0100 2807834 http://www.medworm.com/index.php?rid=2789044&cid=t_112077_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F09%2F12%2Fmoving-out-of-emotional-captivity-are-you-the-driver-or-the-driven%2F In his book “Eastern Wisdom for Western Minds,” Victor M. Parachin tells a Japanese tale about how powerful our emotions can be, and how we must manage them, not vice versa. He writes: A Japanese samurai warrior visited a Zen master, seeking answers to questions that had plagued him for some time. “What is it you want to know?” asked the Zen master. “Tell me, sir, do heaven and hell exist?” “Ha!” laughed the Zen master in a contemptuous tone. “What makes you think you could understand such things? You are only an educated, brutish soldier. Don’t waste my time with your ridiculous questions.” The samurai warrior froze in shock. No one spoke to a samurai that way. It meant instant death. Increasing the tension, the Zen master ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2789044 Sat, 12 Sep 2009 13:17:04 +0100 2789044 http://www.medworm.com/index.php?rid=2778370&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F09%2Flexapro-marketing-plan-was-meant-to.html Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available here. Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose.Continuing Medical EducationOverall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)"One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increas... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2778370 Tue, 08 Sep 2009 20:29:00 +0100 2778370 http://www.medworm.com/index.php?rid=2786002&cid=t_112077_109_f&fid=38951&url=http%3A%2F%2Fcarlatpsychiatry.blogspot.com%2F2009%2F09%2Fforests-promotional-objective-use-cme.html We have known for some time that the actual purpose of industry-sponsored CME (continuing medical education) is to increase prescriptions of the supporter's product. But few will admit it. The ACCME says that it accredits only CME that is unbiased and objective, even though half of it is paid for by the pharmaceutical industry. Leading medical societies appear to be willing to fight to maintain their God-given right to industry funding of CME until the world ends. Finally, a major drug company--Forest Laboratories--has confirmed that CME is, in fact, advertising. In today's New York Times, Gardiner Harris describes a smoking gun document that outlines in stark fashion how Forest has created CME programs for physicians in order to increase market share for Lexapro. The document, entitled "F... The Carlat Psychiatry Blog blogs http://www.medworm.com/rss/comments.php?id=2786002 Tue, 01 Sep 2009 20:50:00 +0100 2786002 http://www.medworm.com/index.php?rid=2757735&cid=t_112077_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FqkW3B5Scmw8%2F It’s summer again, which means it is the time of year for the obligatory photos of wildfires in Southern California. This particular fire, known as the Station Fire, nearly doubled in size in the last 24 hours from 98 to 164 square miles. So far, it has burned at least 18 buildings and cost the lives of at least two firefighters. The fire began in the Angeles National Forest, and Congress will no doubt respond by giving the Forest Service even more money to suppress such fires in the future. In fact, as I show in my Cato Policy Analysis, The Perfect Firestorm, the Forest Service has, in effect, a blank check to put out fires. It freely uses that blank check. It has so far spent about $14 million fighting the Station Fire, which supposedly threatens 12,000 homes. But it has also spent... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2757735 Tue, 01 Sep 2009 19:03:33 +0100 2757735 http://www.medworm.com/index.php?rid=2290611&cid=t_112077_117_f&fid=36026&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Fzimney-health-and-medical-news-you-can-use%2Flexapro-celexa-and-depression%2F Last week’s FDA approval of Lexapro to treat depression in adolescents 12-17 years old got me to thinking both about bureaucratic nonsense and corporate shenanigans. That’s because, in a classic case of bureaucratitis, the FDA approval came just weeks after Justice Department prosecutors, following a 5-year investigation, accused Forest Laboratories of illegally marketing Lexapro for use in these very same children. Of course, such actions are not mutually exclusive because, in fact, it would have been illegal for Forest to promote the use of Lexapro in kids prior to such an FDA approval, but, really, when one arm of the government says it’s now fully convinced of Lexapro’s efficacy in children doesn’t it seem a bit odd that another arm would be spending so mu... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=2290611 Wed, 25 Mar 2009 21:42:16 +0100 2290611 http://www.medworm.com/index.php?rid=2287238&cid=t_112077_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F03%2F19%2Fwhat-was-jama-and-catherine-deangelis-thinking%2F While I was down in Austin at SXSW this past week, there was a rare glimpse into the big egos that run the journal business in the world. As you may know, publishing research articles is a business, and because it involves prestigious reputations — both on the journal and academia side — there is a lot of ego involved. Lots. So imagine if you’re sitting at the head of one of the world’s most prestigious and respected journals, the Journal of the American Medical Association (JAMA), and an academic — not from Harvard or Yale, but from Lincoln Memorial University — calls you on the carpet for failing to conduct a very good peer-review on a peer-reviewed paper appearing in JAMA: Jonathan Leo, a professor of neuroanatomy at Lincoln Memorial University, wrot... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2287238 Thu, 19 Mar 2009 14:58:03 +0100 2287238 http://www.medworm.com/index.php?rid=2260922&cid=t_112077_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F03%2Fmartha-rosenberg-nails-it.html Truth is stranger than fiction (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2260922 Fri, 13 Mar 2009 04:12:00 +0100 2260922 http://www.medworm.com/index.php?rid=2222495&cid=t_112077_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F02%2F26%2Flexapro-maker-accused-of-fraud%2F Yet another story about a drug maker getting into trouble for its off-label marketing practices for a psychiatric medication, this time to children and teens. The drugs? Lexapro and its older sibling, Celexa. The manufacturer of them? Forest Laboratories. The New York Times has the story: In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal. From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2222495 Thu, 26 Feb 2009 19:00:36 +0100 2222495 http://www.medworm.com/index.php?rid=1915072&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F433487216%2F Although initially rejected as ethically questionable, industry funding was eventually sought and used by researchers developing a list of preferred psychiatric drugs for children in state care, according to documents reviewed by The Dallas Morning News. And a spot on the program could have meant millions to drugmakers. The documents released to The News were collected by the Texas attorney general’s office, which is suing Johnson & Johnson’s Janssen Pharmaceutica for allegedly trying to influence researchers on a similar adult drug plan, Texas Medication Algorithm Project, or TMAP. Citing the pending lawsuit over TMAP, officials in two state health agencies declined to comment on the Children’s Medication Algorithm Project, or CMAP – which was put on indefinite h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1915072 Mon, 27 Oct 2008 11:36:52 +0100 1915072 http://www.medworm.com/index.php?rid=1851350&cid=t_112077_109_f&fid=36089&url=http%3A%2F%2Fthesituationist.wordpress.com%2F2008%2F10%2F04%2Fdo-not-read-this-post%2F In their recently published article, “The Great Attributional Divide: How Divergent Views of Human Behavior are Shaping Legal Policy,”Situationist contributors Adam Benforado and Jon Hanson described the psychological phenomenon of “reactance” and the way it encourages a dispositionist perspective.    They write. * * * Another reason that we are inclined toward dispositionist attributions lies in our desire to see ourselves in self-affirming ways.  We like to believe that we are independent, intelligent consumers of life’s many options—the attitude-driven, reasoning, choice-makers of commercials and Westerns.  Rather than victims of situation, we see ourselves as in control of our destinies—not just humans, but “Marlboro Men” or “Virginia Slims.” Our ... The Situationist blogs http://www.medworm.com/rss/comments.php?id=1851350 Sat, 04 Oct 2008 04:01:55 +0100 1851350 http://www.medworm.com/index.php?rid=1834810&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403718711%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here’s a new approach we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Symphony Metreo, which specializes in pricing and operations management programs and systems, has hired Bob Merold, a former IMS Health veteran and one time exec at Procter & Gamble and Bristol-Myers Squib... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834810 Fri, 26 Sep 2008 12:06:32 +0100 1834810 http://www.medworm.com/index.php?rid=1782899&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F387607769%2F The FDA sent a warning letter last month to the drugmaker for promoting its Bystolic high blood pressure med to docs without properly noting the medication’s risk. An 8-page ad, which ran in various medical journals, also implied the drug is better than rival meds even though there is no substantial evidence to prove such claims. “Although the journal ad does include important safety information on its second page, it omits and minimizes certain risks,” wrote Thomas Abrams, head of the FDA’s Division of Drug Marketing, Advertising and Communications in the August 28 letter, which noted the ad specifically left off a warning about the drug’s use in patients with congestive heart failure. The FDA also noted the ad claimed that the beta-blocker works better for p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1782899 Tue, 09 Sep 2008 12:19:00 +0100 1782899 http://www.medworm.com/index.php?rid=1764222&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F382560553%2F Every so often, we like to bring you a few tidbits that are worth noting, if only briefly. This is especially true at lunch hour or during the time of day when a cat nap beckons. Rather than doze off, staying informed is a much better use of time, yes? So, here you go… Hershey Adds Former Pfizer CFO Shedlarz To Its Board (Yahoo/AP) Forest Labs Stock Sinks On Trial Results (Yahoo/AP) ImClone Seeks FDA Ok To Market Erbitux For Head, Neck Cancers (Yahoo/Reuters) OraSure AIDS Test Has High Error Rate (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1764222 Wed, 03 Sep 2008 18:44:06 +0100 1764222 http://www.medworm.com/index.php?rid=1319575&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F255470864%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? Sygnis Pharma hired Frank Rathgeb as chief medical officer; Catalyst named Pat Kenny director of corporate clinical compliance; Maxygen promoted Grant Yonehiro to chief business officer; Zimmer Holdings added Bob Hagemann, a Quest sr vp and cfo to its board; Zimmer Holdings also added Cecil Pickett, Biogen Idec’s R&D chief, to its board... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1319575 Fri, 21 Mar 2008 11:35:24 +0100 1319575 http://www.medworm.com/index.php?rid=1149834&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216412438%2F Is fibromyalgia an example of disease mongering? A new TV ad campaign for Pfizer’s Lyrica, the first med approved to treat the pain condition, argues the affliction is real. But some docs are questioning whether fibromyalgia even exists, The New York Times writes. For patient advocacy groups and doctors who specialize in fibromyalgia, the Lyrica approval is a milestone. They say they hope Lyrica and two other drugs that may be approved this year will legitimize fibromyalgia, just as Prozac brought depression into the mainstream. “What’s going to happen with fibromyalgia is going to be the exact thing that happened to depression with Prozac,” Dan Clauw, a professor of medicine at the University of Michigan, who has consulted with Pfizer and two other drugmakers hoping to market... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1149834 Mon, 14 Jan 2008 12:50:56 +0100 1149834 http://www.medworm.com/index.php?rid=1146763&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F214955028%2F We are easing back into our routine and, like many of you, look forward to the end of the work week. There is, however, much to track. Grab a cup of something hot and dig in….. Genentech Likely To Report Slowed Growth (The Wall Street Journal) Forest Sues Generic Makers Over Alzheimer’s Drug (Yahoo/Reuters) Gilead, Gladstone Institute Strike Research Deal (bizjournals.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1146763 Fri, 11 Jan 2008 12:31:34 +0100 1146763 http://www.medworm.com/index.php?rid=1133907&cid=t_112077_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F212773704%2Fbystolic_gets_fda_approval_for.html Forest Laboratories Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that the U.S. Food and Drug Administration has approved the novel beta blocker Bystolic for the treatment of high blood pressure.Bystolic is a once a day drug that can be used alone or in combination with other hypertension medications in the treatment of high blood pressure. An extensive clinical trial that involved more than 2000 patients, Bystolic showed significant decreases in sitting diastolic and systolic blood pressure. The medication was found to be well tolerated with low incidence of normal beta blocker side effects.Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1133907 Mon, 07 Jan 2008 17:00:11 +0100 1133907 http://www.medworm.com/index.php?rid=1103497&cid=t_112077_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F202250891%2Fforest_labs_and_mylans_bystoli.html Forest Laboratories Inc. (NYSE:FRX) and Mylan Inc.(NYSE:MYL) have received U.S. Food and Drug Administration approval for their beta blocker Bystolic.Bystolic, indicated for the treatment of hypertension, is a one daily medication that can be used in conjunction with other high blood pressure drugs or alone. The drug is a beta blocker which is one of the most prescribed classes of drug in the U.S. In several clinical trials Bystolic showed significant decreases in sitting diastolic and systolic blood pressure in a group of patients that included 26 percent black, 54 percent male, 19 percent elderly and 8 percent diabetic."Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patie... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1103497 Tue, 18 Dec 2007 15:00:43 +0100 1103497 http://www.medworm.com/index.php?rid=1101721&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F202153890%2F Another cold morning in the nation’s medicine chest. We keep warm by finding exciting news. Here are a few examples we can share. Grab a cup of something hot and enjoy… Japan May Lower Drug Prices By 5.2 Percent (Bloomberg News) FDA OKs Hypertension Drug From Mylan & Forest (Yahoo/Reuters) Bristol & Gilead HIV Drug OKed By EU (MarketWatch) Schering-Plough Touts Schizophrenia Drug Study (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1101721 Tue, 18 Dec 2007 11:15:54 +0100 1101721 http://www.medworm.com/index.php?rid=1074997&cid=t_112077_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F196179191%2F 13-year-old Forest Lyvers, who has Asperger Syndrome, is facing expulsion from a Mishawaka, Indiana middle school. As reported by WNDU on December 5th, Forest’s father, Glenn Lyvers, said that his son “made an inappropriate comment to his teacher.” A website created by Lyvers, Forest Matters, provides more information about Forest and his needs, and about a December 5th meeting with the school district. Notes WNDU:  NewsCenter 16 spoke with Lyvers’ Dad, Glenn, before he learned that is son would be able to stay at the school. Late Wednesday, Lyvers says the school has decided that they don’t have enough evidence on the Aspergers disorder to expel Forest. For the past few days, Forest has been at home, suspended from school. Officials at Mishawaka schools did ... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=1074997 Thu, 06 Dec 2007 17:00:45 +0100 1074997 http://www.medworm.com/index.php?rid=1061264&cid=t_112077_136_f&fid=36162&url=http%3A%2F%2Fwww.myelomablog.com%2F2007%2F11%2F30%2Fthis-is-a-neostar-triple-lumen-catheter%2F This is the Neostar triple lumen catheter I had at Wake Forest last year.  It was noticeably heavier than the hickman double lumen. I had this thing in a plastic bag for almost a year. It had never been taken out and cleaned since it was removed, so you can imagine how gunky it was.  [...] (Source: beth's myeloma blog) beth's myeloma blog blogs http://www.medworm.com/rss/comments.php?id=1061264 Fri, 30 Nov 2007 06:24:01 +0100 1061264 http://www.medworm.com/index.php?rid=954382&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170664745%2F The sun is shining this morning on the nation’s medicine chest. Why not grab of cup of coffee or tea and catch up as you prepare to dive back into work? Boston Scientic To Cut Up To 3,400 Jobs (The Boston Globe) Forest Labs Reports Lower Second-Quarter Profits (Yahoo/AP) Medtronic Sued By Patients Over Heart Device Problems (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=954382 Tue, 16 Oct 2007 13:59:19 +0100 954382 http://www.medworm.com/index.php?rid=878191&cid=t_112077_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F157687974%2F As the day winds on, we thought you may like to see a few of the latest items moving over the transom. Hope these help you enjoy your break still more… Forest Labs Partners With Microbia (Yahoo/AP) Depomed Cutting Jobs After Nerve Drug Fails (Bloomberg News) Angiotech Settles Patent Dispute With J&J Unit (Yahoo/AP) FDA And Gene Logic To Set Genomic Standards (DrugResearcher.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=878191 Mon, 17 Sep 2007 17:39:03 +0100 878191 http://www.medworm.com/index.php?rid=769103&cid=t_112077_150_f&fid=35603&url=http%3A%2F%2Fdrugreptoys.blogspot.com%2F2007%2F07%2Fnamenda-pen.html Another one from Namenda, and pretty functional. I'm not a fan of pens with half the body used as a clicker mechanism though, because they have a tendency to open accidentally, leaving black streaks on my nice white coat. (Source: Drug Rep Toys) Drug Rep Toys blogs http://www.medworm.com/rss/comments.php?id=769103 Tue, 31 Jul 2007 00:45:00 +0100 769103 http://www.medworm.com/index.php?rid=651196&cid=t_112077_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F121289784%2F It has been asked: Why, in the face of evidence, do some still believe that autism is mercury poisoning? In a May 18th Science article entitled Childhood Origins of Adult Resistance to Science, Yale University psychology professor Paul Bloom and Yale psychology graduate student Deena Skolnick Weisberg propose that resistance to certain scientific ideas (such neuroscience and evolutionary) originates in childhood “assumptions and biases” that continue on into adulthood. In particular, adults as well as children resist scientific explanations and information when these do not cohere with “common-sense intuitions about the physical and psychological domains”; also, adults as well as children are very much attuned to the “trustworthiness” of the source of th... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=651196 Fri, 01 Jun 2007 05:43:22 +0100 651196 http://www.medworm.com/index.php?rid=549043&cid=t_112077_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F109801243%2F A article in the April 17th Sampson Independent describes how 20-year-old Justin Jones, who has autism, “recently had the chance to be a forest ranger for a day.” Jones met with County Ranger Grant Jones and, attired in yellow and green attire outfitted with a radio and other equipment, “on a variety of different ranger tasks” (Jones, it is noted, has a “love” for electronic devices): As Justin held a hose and sprayed water over the “flames” of a wood fire, he talked with Grant about his efforts in subduing the fire. After a couple minutes, the county ranger informed Justin that he needed to get out of the woods because the tractor plow was going in, a standard practice in dealing with forest fires, he would later explain to Justin. “It’s exc... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=549043 Tue, 17 Apr 2007 16:32:47 +0100 549043 http://www.medworm.com/index.php?rid=624594&cid=t_112077_150_f&fid=35603&url=http%3A%2F%2Fdrugreptoys.blogspot.com%2F2007%2F04%2Fbenicar-post-it-notes.html Just basic post-it notes, tough to go wrong here. (Source: Drug Rep Toys) Drug Rep Toys blogs http://www.medworm.com/rss/comments.php?id=624594 Mon, 16 Apr 2007 04:22:00 +0100 624594 http://www.medworm.com/index.php?rid=543560&cid=t_112077_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F04%2F14%2Fstress-helps-cancer-resist-treatment%2F Filed under: Breast Cancer, Prostate Cancer, Research, Stress Reduction, Daily newsWay to go Wake Forest University scientists -- for adding to the body of evidence connecting stress to illness and for reporting before anyone else that the stress hormone epinephrine causes changes in prostate and breast cancer cells that may make them resistant to death.Emotional stress contributes not only to the development of cancer, says lead researcher George Kulik, D.V.M., Ph.D, but it also reduces the effectiveness of cancer treatments.Previous research shows levels of epinephrine, produced by the adrenal glands, are sharply increased during stressful situations and can stay elevated during long-term stress and depression.During this study, published in the on-line Journal of Biological Chemistry, K... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=543560 Sat, 14 Apr 2007 04:00:00 +0100 543560 http://www.medworm.com/index.php?rid=542516&cid=t_112077_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F04%2Fdire-warning-arrives-in-mail-evidence.html I get all sorts of letters, but this one was striking. It was in an envelope from /alert Marketing, a company which promises to "target physicians by therapy area or by specialty with the #1 rated M.D./alert mail programs." In the envelope was a "dear healthcare provider" letter from one Dan MacDonald, VP for managed healthcare operations from Forest Pharmaceuticals. The letter contained this dire warning:certain managed care organizations have instituted initiatives attempting to switch patients from Lexapro .. to a generic SSRI, including citalopram. However, well-controlled Lexapro patients should not be switched, unless switched for a medical circumstance.. Then, in a black box, it stated (the bold font was in the original):The clinical profile of Lexapro and citalopram are distinct, a... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=542516 Sat, 14 Apr 2007 01:51:00 +0100 542516 http://www.medworm.com/index.php?rid=624596&cid=t_112077_150_f&fid=35603&url=http%3A%2F%2Fdrugreptoys.blogspot.com%2F2007%2F04%2Fnamenda-hand-sanitizer.html I don't know what it is with drug reps and hand sanitizer, but all of them are taking bad advice in the fragrance department. Whoever picked this one needs to be told that "nail polish remover" is not a winning odor. Thumbs down, way down, on this toy. (Source: Drug Rep Toys) Drug Rep Toys blogs http://www.medworm.com/rss/comments.php?id=624596 Mon, 09 Apr 2007 05:02:00 +0100 624596 http://www.medworm.com/index.php?rid=624617&cid=t_112077_150_f&fid=35603&url=http%3A%2F%2Fdrugreptoys.blogspot.com%2F2006%2F11%2Fnamenda-placemarkers.html One of the more ironic drug products out there. Namenda is used in Alzheimer's disease, so they advertise with, yes, stickers to remember your place in a book. (Source: Drug Rep Toys) Drug Rep Toys blogs http://www.medworm.com/rss/comments.php?id=624617 Sat, 04 Nov 2006 23:33:00 +0100 624617 http://www.medworm.com/index.php?rid=624616&cid=t_112077_150_f&fid=35603&url=http%3A%2F%2Fdrugreptoys.blogspot.com%2F2006%2F11%2Fnamenda-pen.html (Source: Drug Rep Toys) Drug Rep Toys blogs http://www.medworm.com/rss/comments.php?id=624616 Fri, 03 Nov 2006 04:07:00 +0100 624616