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 'commission'. Sat, 03 Sep 2011 01:57:51 +0100 http://www.medworm.com/index.php?rid=5182322&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSXrWAMrwa34%2F In an effort to thwart generic competition, brand-name drugmakers are promising not to launch so-called authorized generics if their generic rivals promise not to market copycat versions of the brand-name drugs, according to a new report from the US Federal Trade Commission. The findings, released in a 270-page report, explore a twist on the controversial practice of pay-to-delay in which brand-name drugmakers settle patent litigation with an agreement that involves a payment and a commitment by a generic drugmaker not to launch a rival med for a specified period of time. The FTC has called these deals anti-competitive and cost consumers $3.5 billion annually. Now, the agency, which has been urging Congress to pass legislation to restrict these deals (see here), is turning its attention to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182322 Thu, 01 Sep 2011 12:51:07 +0100 5182322 http://www.medworm.com/index.php?rid=5181762&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F2wBwW5zdM10%2F By Malou InnocentOver the past decade, American taxpayers have lost as much as $60 billion dollars to massive fraud and waste in the nation building campaigns of Iraq and Afghanistan, according to a report released today by the Commission on Wartime Contracting. The independent panel confirms much of what we already know about rent-seeking in wartime; nevertheless, the panel details specific reconstruction projects and programs that display a stunning array of mismanagement: A modest $60 million agricultural development program in northern Afghanistan expanded to the south and east to the tune of $360 million. The cash-for-work program was intended to distribute vouchers for wheat-seed and fertilizer in drought-stricken areas. Today, the program spends $1 million a day. The panel reports,... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5181762 Wed, 31 Aug 2011 18:54:37 +0100 5181762 http://www.medworm.com/index.php?rid=5125720&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FPNFMyAbivyw%2F By Mark A. CalabriaIt’s a little too early to really tell what is going on here, but it certainly looks suspicious to me that a week after the rating agency Standard &Poor’s downgraded the U.S. government, we now have the Securities and Exchange Commission starting an insider-trading investigation of who inside S&P worked on the downgrade.  This comes on top of an announced Senate probe into S&P’s decision. I’ve long argued for reducing the role and influence of the rating agencies when it comes to financial regulation.  One of the few things the Dodd-Frank Act got correct was pushing for a reduction in regulators’ reliance on the rating agencies.  But still, it is nothing short of hypocritical for the same parties who complained that the agenci... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5125720 Fri, 12 Aug 2011 14:53:37 +0100 5125720 http://www.medworm.com/index.php?rid=5107899&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRkVSK5_Bu9Y%2F Good morning, everyone, and nice to see you again. We hope the weekend was invigorating. Now, of course, the time has come to resume the routine of meetings and deadlines, even if it is a slow time of year. To get started, yes, we are brewing that mandatory cup of stimulation, so feel free to join us. Meanwhile, here are some tidibts from around the world. Hope your day goes well and stay in touch… Pfizer And UCSD Collaborate On Early Drug Discovery (San Diego Union Tribune) China’s Healthcare Push May Curb Sales For Brand-Name Pharma (Bloomberg News) Nestle Eyes Pfizer Formula Milk Powder Business (Business China) EU Approves Botox For Treating Urinary Incontinence (Reuters) Takeda Pharmaceuticals Faces Rising Number Of Actos Lawsuits (Associated Press) Bayer Is Eyeing Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107899 Mon, 08 Aug 2011 11:50:32 +0100 5107899 http://www.medworm.com/index.php?rid=5077874&cid=t_207803_125_f&fid=34819&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FFullosseousflapsDentalBlog%2F%7E3%2FnyzqjIWWzyI%2F Well, almost final. The commission just voted out the new state lines on a 12-2 vote (with two Republicans voting no) and placed them on the Agenda for an official August 15th final vote.  Until then feel free to whine, complain, cuss and gripe to commissioners about their failures.  They can hear you, but they’re probably done listening. On August 15th the only option is an up-or-down vote on the maps.  You cannot have your city reunited, get your Assembly Member back.  The plans are final and the only option now would be for the commission to vote the plans down and send them directly to the courts. The game now transitions from the 14 members of the commission to the 67 members of Congress and the Legislature that have been drawn out of their seats, nested with ot... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=5077874 Fri, 29 Jul 2011 19:42:23 +0100 5077874 http://www.medworm.com/index.php?rid=5069818&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrIaNzGppPTA%2F Three years after making a proposal that would have allowed drugmakers to publish product information in consumer newspapers and magazines, the European Commission is going back to the proverbial drawing board and plans to issue a new proposal this fall, an EC spokesman writes us. The move comes after its initial effort was widely criticized and rejected by the European Parliament. “The European Commission will revise the proposals to clarify and harmonize the rules in what companies can and can’t say to patients,” Peter Arlett, who heads pharmacovigilance and risk management at the European Medicines Agency, tells Bloomberg News. The EMA, he adds, recently received a letter from the EC about its intention to revise its proposal. The original EC effort, which was unveiled in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069818 Wed, 27 Jul 2011 18:04:00 +0100 5069818 http://www.medworm.com/index.php?rid=5062337&cid=t_207803_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fdownside-patient-centered-medical-homes-social-media-conversations Last week, Diana Manos, senior editor at Healthcare IT News, reported on the importance of patient-centered medical homes. She covered the annual National Health IT and Delivery System Transformation Summit, which displayed how PCMH can greatly reduce costs and improve care. One of her sources, James Dearing, DO, a family practice physician, outlined four benefits of a patient-centered home. Here is a recap: read more (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=5062337 Mon, 25 Jul 2011 20:34:37 +0100 5062337 http://www.medworm.com/index.php?rid=5062371&cid=t_207803_125_f&fid=34819&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FFullosseousflapsDentalBlog%2F%7E3%2FlyAfVQLs4w4%2F A morning collection of links and comments about my home, California. However we vote, Amazon loses A Times-USC poll last week showed a close contest. After registered voters were read some arguments on both sides, the so-called Amazon tax was supported by 46% and opposed by 49%. Looking inside the numbers, two factors stood out, neither shocking. A majority of Democrats (52%) favored collecting the tax online; the majority of Republicans (59%) opposed it. Independents were almost evenly split. There was a generational divide: The younger the voters, the more opposed they were to online tax collections. The older, the more supportive. Specifically, 55% of people under 50 were opposed, 52% of the over-50 crowd supported it. The conflicting political dynamic is this: The best bet is there&#8... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=5062371 Mon, 25 Jul 2011 14:32:19 +0100 5062371 http://www.medworm.com/index.php?rid=5051240&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff0rmi8u5dV8%2F The US Senate Judiciary Committee has approved a bipartisan bill that would limit pay-to-delay settlements that are designed to keep lower-cost generic drugs off the market for extended periods. The move comes after the US Supreme Court declined to review one hotly contested deal (see this) amid repeated cries from the US Federal Trade Commission that settlements are anticompetitive and costly to consumers. Under the bill, which is called the Preserve Access to Affordable Generic Drugs Act, brand-name drugmakers would be deterred from settling patent disputes by paying generic rivals in exchange for promises that a copycat version of its drug will be kept off the market. The deals would be considered illegal and the FTC would be given the authority to stop the agreements (read the legislat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051240 Thu, 21 Jul 2011 20:04:25 +0100 5051240 http://www.medworm.com/index.php?rid=5050886&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FVVWQ9K_jIAo%2F The Implementation Guide for The Joint Commission Patient Blood Management Performance Measures 2011 is now available.   Detailed specifications are provided for seven measures related to transfusions and select elective surgery patients.   The 2011 JC Patient Blood Management Implementation Guide (Source: MSSPNexus Blog) MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=5050886 Mon, 18 Jul 2011 12:13:36 +0100 5050886 http://www.medworm.com/index.php?rid=5028153&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F2BZuoMHpplg%2F By Chris EdwardsSenate Minority Leader Mitch McConnell has offered the president a way to raise the debt ceiling by $2.5 trillion without having to cut spending. The WaPo reports that “McConnell’s strategy makes no provision for spending cuts to be enacted.” This appears to be an epic cave-in and completely at odds with McConnell’s own pronouncements in recent months that major budget reforms must be tied to any debt-limit increase. House Republicans should obviously reject McConnell’s surrender, and they should do what they should have done months ago. They should put together a package of $2 trillion in real spending cuts taken straight from the Obama fiscal commission report and pass it through the House tied to a debt-limit increase of $2 trillion. Then they shouldn’t budge... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5028153 Wed, 13 Jul 2011 14:37:47 +0100 5028153 http://www.medworm.com/index.php?rid=5008155&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FZM20phiwWic%2F By Daniel J. MitchellI’m not a big fan of the rating agencies. I’ve warned in TV interviews that they generally wait too long before downgrading profligate governments. So when the rating agencies finally catch up to everyone else and lower their outlook for failing welfare states such as Greece and Portugal, one would think that this would be seen as a useful – albeit late – warning sign. But European politicians are not very happy about this development. At the risk of mixing metaphors, they want everyone to keep their heads buried in the sand and to continue complimenting the emperor on his new clothes. Here are some excerpts from a BBC report. The European Commission has strongly criticised international credit ratings agencies following the downgrade of Portugal by Moody�... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5008155 Wed, 06 Jul 2011 14:29:15 +0100 5008155 http://www.medworm.com/index.php?rid=4992685&cid=t_207803_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnurse-prompts-are-key-to-successful-implementation-of-icu-safety-measures%2F2011.07.02 Over the last few years, you may have heard a lot about the value of checklists in ICU medicine and their ability to reduce mortality, reduce cost and reduce length of stay.   But a recent study took the concept one step further and suggested that checklists by themselves may not be  effective unless physicians are prompted to act on the checklist. As reported in the American Journal of Respiratory and Critical Care Journal, a single site cohort study performed at Northwestern University Feinberg School of Medicine’s medical intensive care unit compared two rounding groups of physicians.  One group was prompted to use the checklist.  The other group of physicians had access to the checklist but were not prompted to use it. What they found was shocking.  Both groups had access t... Better Health blogs http://www.medworm.com/rss/comments.php?id=4992685 Sat, 02 Jul 2011 16:10:00 +0100 4992685 http://www.medworm.com/index.php?rid=4975833&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FFJsb-MgrxMU%2F By Walter OlsonLast December the Consumer Product Safety Commission (CPSC) adopted new standards for crib design, a step mandated by the famously overreaching Consumer Product Safety Improvement Act of 2008 (CPSIA). The commission decided to go well beyond a set of voluntary design standards that had been widely adopted the year before; it also chose to make the new rules retroactive, rendering unlawful the sale of many existing cribs whose overall safety record is otherwise acceptable—no one would think of subjecting them to a recall, for instance. Commissioner Nancy Nord: The day care industry did protest that the rule, as proposed, would result in approximately a $1/2 billion hit to a group that could not immediately absorb costs of such magnitude, especially on the heels of having ju... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4975833 Tue, 28 Jun 2011 13:26:01 +0100 4975833 http://www.medworm.com/index.php?rid=4976210&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Frveg3vLj9MY%2F The UK government has filed a lawsuit seeking about $351 million in damages against Servier Laboratories over charges the French drugmaker “abused” its dominant position by delaying rivals from launching generic versions of a blood pressure drug, The Financial Times writes. Health Secretary Andrew Lansley and more than 150 primary care trusts claim that between July 2001 and July 2007, Servier schemed to prevent a generic form of Aceon, or perindopril, from reaching the market, the paper continues. Consequently, the National Health Service paid “elevated prices.” The Servier patent on Aceon expired in 2003, but a generic did not appear in the UK until July 2007. The lawsuit cites documents showing Servier applied to the European Patent Office for another patent during t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976210 Mon, 27 Jun 2011 15:07:38 +0100 4976210 http://www.medworm.com/index.php?rid=4921757&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC0tblUFA4DY%2F In what some say would be a highly unusual move, the US Federal Trade Commission is considering using its rule-making power to stop pay-to-delay deals between brand-name drugmakers and their generic rivals, after failing to convince Congress or the courts to act, Bloomberg News reports. A rule to block the deals would involve antitrust issues, rather than consumer protection, and could be made on the agency’s own initiative under its basic statutory authority rather than at the direction of Congress, Bert Foer, president of the American Antitrust Institute, tells the news service. “Any potential attempt by the FTC to move forward unilaterally with such a rulemaking would be unprecedented,” Sean Heather, executive director of the global regulatory cooperation project at the US Cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921757 Thu, 09 Jun 2011 15:10:23 +0100 4921757 http://www.medworm.com/index.php?rid=4902405&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FI8niYC-xAnE%2F By Jim HarperIt might be tempting to laugh at France’s ban on words like “Facebook” and Twitter” in the media. France’s Conseil Supérieur de l’Audiovisuel recently ruled that specific references to these sites (in stories not about them) would violate a 1992 law banning “secret” advertising. The council was created in 1989 to ensure fairness in French audiovisual communications, such as in allocation of television time to political candidates, and to protect children from some types of programming. Sure, laugh at the French. But not for too long. The United States has similarly busy-bodied regulators, who, for example, have primly regulated such advertising themselves. American regulators carefully oversee non-secret advertising, too. Our govern... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4902405 Mon, 06 Jun 2011 16:35:53 +0100 4902405 http://www.medworm.com/index.php?rid=5159035&cid=t_207803_90_f&fid=36413&url=http%3A%2F%2Fwww.dcscience.net%2F%3Fp%3D4422%26utm_source%3Drss%26utm_medium%3Drss%26utm_campaign%3Dwilletts-private-university-in-trouble-private-eye-explains Jump to follow-up We live under a highly ideological government. It wishes to privatise everything in sight, not least universities and the National Health Service. Of course they don’t put it that way: they call it “reform”. It’s easier to deal with open ideology than with ideology disguised as social reform, but luckily a 10-year old could see through the weasel words. One example is the raising of tuition fees to £9,000 pa. It costs the taxpayers more than charging £3,000 did. Students obviously lose, and universities probably lose too. It takes a very blind form of ideology to devise a system in which all three parties lose money, for the sake of a principle. No doubt Education Minister David Willetts was moved by the same ideological considerations... DC's goodscience blogs http://www.medworm.com/rss/comments.php?id=5159035 Sat, 28 May 2011 10:47:25 +0100 5159035 http://www.medworm.com/index.php?rid=4862919&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFTY9Q97A1IU%2F After months of intense debate, the US Securities and Exchange Commission has finally announced rules to implement the whistleblower provisions in the Dodd-Frank Wall Street Reform and Consumer Protection Act. And the final version is a rebuff to many companies - including several drugmakers, such as Pfizer and GlaxoSmithKline - which lobbied for constraints. Here’s why: under the rules, employees will not be required to first report concerns internally to their employers before going to the government. Many large companies fought for the requirement, but advocates objected over concerns that legitimate problems may not be properly investigated and that employees might face retaliation (back stories here and here). “Not requiring internal reporting before providing information... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862919 Wed, 25 May 2011 19:59:09 +0100 4862919 http://www.medworm.com/index.php?rid=4862924&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPY8LOK5kv_0%2F Once again, the US Federal Trade Commission is trying to thwart pay-to-delays deals and its latest effort is a brief in which the agency has asked an appeals court to reverse a lower court ruling that sanctioned a settlement between Schering-Plough and two generic drugmakers - Upsher Smith and ESI, which was a division of Pfizer’s Wyeth - over the K-Dur blood pressure med. The background: In 1995, the two generic drugmakers sought FDA approval to sell versions of K-Dur, but Schering-Plough, now owned by Merck, filed suit for patent infringement. Just before the trial, Schering-Plough agreed to pay Upsher $60 million not to sell a generic until 2001, and the FTC filed suit (read here). Separately, Schering-Plough agreed to pay ESI up to $15 million to agree not to sell a generic until... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862924 Wed, 25 May 2011 12:02:39 +0100 4862924 http://www.medworm.com/index.php?rid=4813464&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FJV1kjG1zpdg%2F The Joint Commission released a statement applauding the revised Centers for Medicare & Medicaid Services (CMS) Telemedicine Credentialing and Privileging requirements. The new rule, long supported by the Joint Commission, becomes effective on July 5, 2011. The rule, which applies to all hospitals that participate in Medicare, and inpatients at critical access hospitals (CAH), upholds The Joint Commission’s current practice of allowing the hospital or CAH to utilize information from the distant-site hospital or other accredited telemedicine entity when making credentialing or privileging decisions for the distant-site physicians and practitioners. (Source: MSSPNexus Blog) MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=4813464 Wed, 11 May 2011 12:25:08 +0100 4813464 http://www.medworm.com/index.php?rid=4797823&cid=t_207803_111_f&fid=39123&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fnursingcomments%2Ftdtc%2F%7E3%2FqijT1OKVagU%2F This is a guest post by Patricia Walling who is a web content creator with an avid interest in healthcare and nursing.  Patricia can be reached by email at: patwalling85@gmail.com As a field, nursing has seen an explosion in growth in recent years. The aging of the American population has led the Bureau of Labor and Statistics to predict job growth to increase by 22 percent by 2018, far out-stripping the national average. For many, the good pay and job security (which is even better than that of other popular fields, such as medical transcription) of nursing have made it an ideal career path, and nursing schools have blossomed across the country. However, each school has its own unique advantages and disadvantages and a number of factors should be considered before you select a school. W... Nursing Comments blogs http://www.medworm.com/rss/comments.php?id=4797823 Sat, 07 May 2011 13:29:53 +0100 4797823 http://www.medworm.com/index.php?rid=4789641&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F919qtSMsjE4%2F Despite setbacks in courts and Congress, the Federal Trade Commission continues to hammer away at pay-to-delay deals involving patent settlements between brand-name and generic drugmakers. The agency views these deals as anti-competitive, arguing they rob consumers of lower-cost meds that might otherwise arrive much sooner in pharmacies. And so the FTC chair Jon Leibowitz has released yet another report that he hopes will generate some momentum in Congress toward restricting these agreements. The report found there 31 deals in fiscal year 2010, a 63 percent increase from fiscal year 2009. The deals reached in the last year involved 22 different brand-name meds with combined annual US sales of about $9.3 billion. Of the 31 settlements, 26 involved generics that were “first filers,” whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789641 Wed, 04 May 2011 12:39:30 +0100 4789641 http://www.medworm.com/index.php?rid=4780291&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FzRRDs2EfY94%2F By Neal McCluskeyThere is a reason “ivory tower” has a negative connotation, evoking images of effete snobs walled away in ivory opulence as they look down on the commoners and demand outsized respect. The image, unfortunately, is occasionally accurate for individual academics, and almost always so for the whole of academia, which is funded by massive subsidies taken from taxpayers, but walled off by claims that no price can or should ever be affixed to the “public good” it produces. Add to this its professorial residents often demanding limitless freedom — and job security – to say whatever they want about such evil pursuits as “big business” that generate the tax dollars that keep the tower cushy and its jobs secure, and... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4780291 Tue, 03 May 2011 20:13:01 +0100 4780291 http://www.medworm.com/index.php?rid=4715014&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYq3k6eZCQ4%2F Four years after the merger between the CVS drugstore chain and the Caremark pharmacy benefits manager, which has spurred numerous investigations and lawsuits over anticompetitive concerns, a handful of consumer groups have written the US Federal Trade Commission to ask the agency to break up the company. Why? The groups charge CVS Caremark limits choice through various programs, the merger has given CVS unfair advantage over other retailers, patients are steered toward CVS and confidential patient information is improperly shared. Such concerns have already prompted investigations by the FTC and attorneys general of 24 states. CVS Caremark has previously said it is cooperating with the probes. “There is strong evidence that the CVS Caremark merger has harmed consumers,” says the lett... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715014 Fri, 15 Apr 2011 12:18:08 +0100 4715014 http://www.medworm.com/index.php?rid=4709193&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FWnFchbuPUyw%2F By Daniel J. MitchellIn his speech this afternoon, President Obama is expected to call for, among other things,  an increase in taxes on investors, entrepreneurs, small business owners, and other “rich” people who make over $250,000 a year.  The goal, the President claims, is to reduce deficits. America has a spending problem, not a revenue problem, as the Congressional Budget Office chart below shows. The federal budget has ballooned nearly $2 trillion in the past 10 years and that increased burden of spending is undermining growth. And if left on autopilot, the spending crisis will get worse in coming decades. Rather than trying to keep up with that growing burden of government — an impossible task —  by raising taxes, our leaders should be looking at ways to... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4709193 Wed, 13 Apr 2011 14:19:10 +0100 4709193 http://www.medworm.com/index.php?rid=4684265&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FlMc1JdHkAwQ%2F By Jim HarperSan Francisco's Entertainment Commission will soon be considering a jaw-dropping attack on privacy and free assembly. Here are some of the rules the Commission may adopt for any gathering of people expected to reach 100 or more: 3. All occupants of the premises shall be ID Scanned (including patrons, promoters, and performers, etc.). ID scanning data shall be maintained on a data storage system for no less than 15 days and shall be made available to local law enforcement upon request. 4. High visibility cameras shall be located at each entrance and exit point of the premises. Said cameras shall maintain a recorded data base for no less than fifteen (15 days) and made available to local law enforcement upon request. Would you recognize a police state if you lived in one? How ab... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4684265 Wed, 06 Apr 2011 23:42:28 +0100 4684265 http://www.medworm.com/index.php?rid=4676779&cid=t_207803_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FQjV-tryLFQ4%2F By Glenna Crooks. Having been engaged in rare disease research and orphan drug development for many decades and as one who continues behind-the-scenes to encourage the work, events of the last few weeks about Makena’s launch sent chills through me.  The firestorm that followed created some heat but none sufficient to help relieve the shivers. Others might declare the outcome a “win” but the more I read, the worse it seems. I’m not privy to what really happened, only what the press reports. It does not look good… for virtually anyone of the players involved, especially the critics.  Those critics raised tough questions and to date only the company has faced them. It’s about time the critics themselves –and perhaps others as well – face some.    For those who’ve mi... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=4676779 Mon, 04 Apr 2011 09:31:25 +0100 4676779 http://www.medworm.com/index.php?rid=4664471&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBooQH9h2fi8%2F Under enormous political pressure and undercut by an unexpected FDA decision earlier this week, KV Pharmaceuticals has lowered the price of its Makena injectable drug for premature births by nearly 55 percent, to $690 per injection. Previously, KV hoped to charge $1,500. Despite the decrease, this is still considerably more than the $10 to $20 that compounding pharmacies typically charge. Nonetheless, KV maintains the price drop, supplemental rebates and the standard 23.1 percent Medicaid rebate “will result in a substantially reduced cost per injection for state Medicaid agencies compared to list price. This will help ensure that every woman who is prescribed Makena – regardless of her ability to pay – has the comfort of knowing a medication that has been rigorously reviewed by ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664471 Fri, 01 Apr 2011 15:18:27 +0100 4664471 http://www.medworm.com/index.php?rid=4658621&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_coAu5MMn48%2F In response to threats KV Pharmaceuticals has made to compounding pharmacies that want to continue making low-cost versions of its high-priced Makena preemie drug, the FDA has just issued a statement saying the agency will not take any “enforcement actions” against compounders. The “FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct,” the FDA statement says. “In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658621 Wed, 30 Mar 2011 14:43:43 +0100 4658621 http://www.medworm.com/index.php?rid=4658625&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FywfQAM3CoRc%2F Earlier this month, controversy erupted after KV Pharmaceuticals began charging $1,500 for an injection of its Makena drug for preventing premature births. Why? Makena is actually a form of progesterone that has been available for decades from compounding pharmacies at roughly $10 to $20 a week (read this and this). Now, though, KV Pharma has a lock on the market, because Makena is the only drug approved by the FDA for this purpose. Two US senators, however, asked the US Federal Trade Commission to investigate and various patient groups are pressuring KV to lower its price. We spoke with Alan Fleischman, medical director at the March of Dimes, which has received some $1 million in donations from KV over the past decade, but issued a harsh condemnation (see this). This chat occurred just be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658625 Wed, 30 Mar 2011 12:22:30 +0100 4658625 http://www.medworm.com/index.php?rid=4653306&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FSM08H5Zny0A%2F By Jim HarperRandy May of the Free State Foundation has a characteristically good post about the AT&T/T-Mobile merger entitled: "The AT&T and T-Mobile Merger: Thinking Things Through." Among other smart ideas, Randy highlights the competitive game-playing that goes on in the merger review arena: When considering competitive and market impacts for purposes of merger reviews, observe the extent to which various competitors, often many competitors, mount vigorous campaigns designed to convince the antitrust authorities and the regulators that if the merger is approved there will be an absence of competition. Note the incongruity. There's level-headed thinking aplenty in this post from a long-time Federal Communications Commission and telecom-industry watcher. Check it out. Thinking Th... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4653306 Tue, 29 Mar 2011 20:38:57 +0100 4653306 http://www.medworm.com/index.php?rid=4670081&cid=t_207803_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fthose-who-dismiss-heathcare-and-healht.html At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.For me, this is no longer merely a professional debate. My elderly mother became one of those "anecdotes" in M... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4670081 Sun, 27 Mar 2011 12:12:00 +0100 4670081 http://www.medworm.com/index.php?rid=4642550&cid=t_207803_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fthose-who-dismiss-heathcare-and-healht.html At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.For me, this is no longer merely a professional debate. My elderly mother became one of those "anecdotes" in M... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4642550 Sun, 27 Mar 2011 12:12:00 +0100 4642550 http://www.medworm.com/index.php?rid=4636658&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA99JMnl2Rrw%2F For the second time this month, the US International Trade Commission has agreed to investigate a complaint hinging on a patent dispute involving different drugmakers. This time around, Femira Pharma accuses Merck and numerous retailers, including CVS Caremark Wal-Mart, of infringing on a patent because the drugmaker and pharmacies import or sell Merck’s NuvaRing vaginal ring birth control device (see the ITC notice). In its complaint, Femira argues its patent generally relates to a medicated intravaginal device, such as a vaginal ring, for transvaginal delivery of a medication to a woman’s uterus. Femira also maintins the drug delivery system described in its patent allows delivery in lower concentrations than those needed for systemic treatment and so offers a lower systemic ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636658 Fri, 25 Mar 2011 14:46:48 +0100 4636658 http://www.medworm.com/index.php?rid=4631465&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fue904-gifrM%2F By Jim HarperMatt Yglesias takes my recent post gathering three links a little too seriously. Beyond their subject matter---the proposed merger of AT&T and T-Mobile---the theme running through the links was that they were all to the TechLiberationFront blog, not that "the federal government should not try to manage the development of the communications marketplace." My humor is a little odd. Not everyone gets to come along.... But it's true that the federal government should not try to manage the development of the communications marketplace. So I'll defend that, and first principles, which Yglesias claims to have reached their limits when it comes to communications. First, I'll refine my thesis: the government should not manage the communications marketplace. What is a "marketplace"?... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4631465 Thu, 24 Mar 2011 15:46:43 +0100 4631465 http://www.medworm.com/index.php?rid=4622229&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FSfmPjGV3c8s%2F By Jim HarperNews that AT&T plans a purchase of T-Mobile has brought out a lot of commentary. On the TechLiberationFront blog, Larry Downes critiqued the emotional reaction of some advocates for government-managed communications. On the TechLiberationFront blog, Jerry Brito noted how the deal highlights the artificial spectrum scarcity created by the Federal Communications Commission. And on the TechLiberationFront blog, Adam Thierer catalogued a series of thoughts on various aspects of the merger. Picking up a theme? That's right: the federal government should not try to manage the development of the communications marketplace. Voices on the AT&T – T-Mobile Merger is a post from Cato @ Liberty - Cato Institute Blog (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4622229 Tue, 22 Mar 2011 14:19:07 +0100 4622229 http://www.medworm.com/index.php?rid=4615429&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4eYAhPyUqZA%2F In an unusual move to thwart generic competition, Eli Lilly has succeeded in convincing the US International Trade Commission to investigate its complaint that Hospira and three suppliers are using a manufacturing process that infringes a patent on its Gemzar cancer med. And Lilly hopes the ITC will block importation of Hospira’s generic version, which is known as gemcitabine (see ITC notice here). In its complaint, Lilly charges that the patented method for making Gemzar, which is used to treat breast, lung, ovarian and pancreatic cancer, is “the most commercially viable process available for manufacturing gemcitabine” and “involves less steps, higher yields and lower costs,” according to the Lilly complaint. Hospira and its suppliers are charged with illegal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4615429 Mon, 21 Mar 2011 11:58:20 +0100 4615429 http://www.medworm.com/index.php?rid=4592689&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUdLb4vh7Hrs%2F What if a pharma exec was supposed to be sentenced for a misdemeanor but, due to a change in sentencing guidelines, was instead going to receive a harsher sentence usually meted out for felonies? Depending upon your station in life, this may be a good thing or a bad thing. If you happen to be the exec, however, this is probably not a good thing. But if a recent proposal goes into effect, well… tough luck. What are we talking about? Two months ago, the US Sentencing Commission issued a proposal to amend the sentencing guidelines that would impose tougher punishments for anyone convicted of so-called strict liability offenses under the Food, Drug & Cosmetic Act (look here). In legal lingo, the difference is between between following the 2B guidelines for fraud instead of the curre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592689 Tue, 15 Mar 2011 12:15:58 +0100 4592689 http://www.medworm.com/index.php?rid=4570603&cid=t_207803_112_f&fid=34971&url=http%3A%2F%2Fdoctorandpatient.blogspot.com%2F2011%2F03%2Fspringtime-in-mumbai-ivf-success-story.html My husband and I have been married for seven years, and are now 11 weeks pregnant! Even with the euphoria of this moment I don’t want to forget the journey of three years that brought us here, and Dr. Malpani and his team have been like a guiding light in this.The ‘TTC’ CoupleWe wanted the first few years of our marriage for ourselves and made the most of them by traveling all we wanted, my establishing myself in my career and having time with each other. After the fourth year we started trying for a baby, once the initial 7-8 months were over we started to think that we should get a medical opinion so that we can eliminate the possibility of a problem or rectify it if there’s one. We met our OB&G and she suggested a few basic tests, based on these she started some medication f... The Patient's Doctor blogs http://www.medworm.com/rss/comments.php?id=4570603 Thu, 10 Mar 2011 09:10:00 +0100 4570603 http://www.medworm.com/index.php?rid=4560597&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC7Wu-i1zM6o%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling the short people off to their various school houses for some learning. And this marathon calls for a much needed cup of stimulation - our flavor today is Cinnamon Cream Swirl. Please join us as we also peruse the news for interesting developments. As always, we encourage you to contact us if you hear of something noteworthy. Meanwhile, have a great day… FDA Warns About Abbott HIV Med In Premature Babies (Reuters) Teva Says Docs Contacted For Generic Copaxone Study (Bloomberg News) FDA Accepts Application For Astra & Bristol Diabetes Drug (Associated Press) Japan Finds No Direct Link To Vaccines And Deaths (Reuters) FTC Takes Aim At Patent T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560597 Tue, 08 Mar 2011 12:53:17 +0100 4560597 http://www.medworm.com/index.php?rid=4560598&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDDJwXnTTp4M%2F The Supreme Court rejected a challenge to a pay-to-delay deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop a patent lawsuit over the Cipro antibiotic (see this). The move is a blow to the Federal Trade Commission, which calls the deals anticompetitive and had been hoping the Supreme Court would review a case in the face of legislative inactivity. The issue has divided lower courts around the country for years. A wholesaler and three retailers, including CVS and Rite-Aid, asked the Supreme Court to review the settlement, arguing the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. In the case they cited, Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997 tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560598 Mon, 07 Mar 2011 22:44:07 +0100 4560598 http://www.medworm.com/index.php?rid=4522288&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9JI7t-4bhHU%2F Last month, FDA device chief Jeff Shuren committed a diplomatic faux pas. While speaking with reporters about varying approval standards and safety issues in the US and Europe, he quoted a surgeon who supposedly said “under the EU system, the public are being used as guinea pigs.” And then he added his own two cents by saying that “we don’t use our people as guinea pigs in the US.” Not surprisingly, someone in Europe has taken exception - Paola Testori Coggi, the European Commission’s Directorate-General for Health and Consumers, wrote a letter to FDA commish Margaret Hamburg to complain. “I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way,” Coggi wrote in the Feb. 18 ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522288 Fri, 25 Feb 2011 13:56:19 +0100 4522288 http://www.medworm.com/index.php?rid=4495432&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhzVMM9bdJ8U%2F A handful of Senate Democrats have revived a bill that would restrict brand-name drugmakers from being able to market an authorized generic during the 180-day exclusivity period that follows the first successful challenge to a patent by a generic rival. Known as the Fair Prescription Drug Competition Act, the bill was first introduced by US Senator Jay Rockefeller, a West Virginia Democrat, in 2007. Authorized generics, as you know, may be sold by brand-name drugmakers after a patent expires, although marketed differently. However, a 2009 report by the US Federal Trade Commission found that consumers are harmed by deals between brand-name and generic drugmakers in which a generic entry is delayed. The FTC noted that the arrival of an authorized generic during that 180-day exclusivity perio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495432 Fri, 18 Feb 2011 17:10:06 +0100 4495432 http://www.medworm.com/index.php?rid=4489684&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2011%2F02%2Fshould-jcaho-regulate-family-visitation%2F I had a whole story ready to post about another very sick child that we treated, but decided to leave a more general issue instead. When there are critically ill patients, the staff has to think quickly and act quickly. Interruptions are counterproductive to our job during those times. Think about trying to concentrate on something – whether it be driving and trying to find a street address, talking on the phone, or trying to figure out a crossword puzzle – and being interrupted by your kids. The interruptions knock you off track from the task at hand. There was a 6 month old who was critically ill in our department. With children, tasks such as starting IVs and intubating them are more difficult, and you also need to check the dosages of medications that they’re being gi... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=4489684 Wed, 16 Feb 2011 18:05:38 +0100 4489684 http://www.medworm.com/index.php?rid=4482745&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FG2b5b7cI130%2F By Daniel J. MitchellI looked yesterday at the spending side of Obama's budget and found some good news and bad news. The good news was the absence of any big new initiative to expand the burden of government. That's a welcome relief since the past couple of years have featured budget busting proposals such as the so-called stimulus scheme and a government-run healthcare plan. The bad news is that the budget does nothing to undo any of the damage of the past two years. Nor does it undo any of the damage of the previous eight years. And because the President's budget refuses to address entitlement spending, it certainly doesn't do anything to avert the damage of rapidly expanding budgets over the next several decades. Now let's look at the tax side of the fiscal equation. In large part, the... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4482745 Tue, 15 Feb 2011 15:52:28 +0100 4482745 http://www.medworm.com/index.php?rid=4477693&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F2_YoSWRJyGU%2F By Chris EdwardsA lot has happened since President Obama introduced his last budget in February 2010. His party took an historic "shellacking" at the polls for its big government policies, his Fiscal Commission recommended serious spending cuts, and European governments have illustrated the severe problems of deficit spending.   Given all this, did the president adopt a more frugal and prudent approach in his new budget yesterday? Not at all--the spending levels in his new budget are virtually the same as the unsustainably high spending levels in his February 2010 budget. The chart shows Obama's proposed spending for FY2012 from last year's budget, and his proposed spending for the same year from his new budget.  His new budget proposes slightly more discretionary and ent... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4477693 Tue, 15 Feb 2011 14:07:45 +0100 4477693 http://www.medworm.com/index.php?rid=4455272&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2011%2F02%2Fsafety-of-medical-care-in-us%2F Remember that statistic from the 1999 Institute of Medicine report that trial lawyers like to throw in everyone’s face about how “up to 98,000 people in the US die each year due to medical mistakes”? It’s like TWO 737 jetliners crashing every day … and we’re doing nothing about it. So today a news story was sent to my inbox that included Saudi Arabian Ministry of Health statistics on medical malpractice. The report shows that there were 1,356 cases of malpractice in Saudi Arabia in 2009 and that “129 people died from medical mistakes in 2009.” Of course, the 129 number seemed quite low to me given the 98,000 number that is constantly cited in the press. Maybe Saudi Arabia’s population is just smaller than I thought. Nope. Saudi Arabia h... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=4455272 Wed, 09 Feb 2011 10:29:25 +0100 4455272 http://www.medworm.com/index.php?rid=4399818&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVytK4mo5a_A%2F A pair of US Senators have reintroduced legislation that would limit the so-called pay-to-delay deals that remain one of the hottest controversies enveloping the pharmaceutical industry. The move comes after the House and Senate last month failed to agree on an appropriations bill, which included pay-to-delay restrictions. You may recall that pay-to-delay settlements involve agreements in which brand-name and generic drugmakers settle patent disputes by exchanging a payment for a commitment to refrain from marketing a generic off the market for a set period of time. However, the Federal Trade Commission calls these deals anti-competitive and force consumers and government healthcare programs to pay high prices. A Congressional Budget Office report estimated the federal government could sav... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399818 Wed, 26 Jan 2011 18:11:24 +0100 4399818 http://www.medworm.com/index.php?rid=4377787&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4361306&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUuhSDJneggs%2F One month after yet again raiding offices of various drugmakers (back story), the European Commission is now taking a more polite approach and telling several companies - including Bayer and Roche - to submit details of their settlements over patent disputes. The EC asked a “selected number of originator and generic companies” to submit a copy of all patent settlement agreements relevant to the 27-member EU region and which were concluded between Jan. 1, 2010 and Dec. 31, 2010, according to an EC statement. Like the US Federal Trade Commission, the EC has been probing these pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). This followed a report from the Europe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361306 Tue, 18 Jan 2011 14:20:42 +0100 4361306 http://www.medworm.com/index.php?rid=4343114&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F0ud79KYaN3E%2F By Tad DeHavenRep. Kevin Brady (R-TX) has introduced the Cut Unsustainable and Top-heavy Spending Act, which would cut spending by $44 billion annually.  Brady’s effort moves in the right direction but it is a very modest fiscal reform effort. The legislation, which Brady calls a “down payment on getting America’s financial books in order,” chooses targets that have already been proposed by the Obama administration or the president’s Fiscal Commission. Therefore, the proposal should have bipartisan appeal. For example, Brady’s bill would cut Pentagon spending and eliminate subsidies to the Corporation for Public Broadcasting. Many of the targets represent “house cleaning cuts” that would reduce spending on bureaucratic activities such as printing and federal travel. Th... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4343114 Thu, 13 Jan 2011 14:59:32 +0100 4343114 http://www.medworm.com/index.php?rid=4331236&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FED0DYDEIm1U%2F The controversy over so-called pay-to-delay settlements between brand-name and generic drugmakers has prompted attorneys general from 32 states to file an amicus, or friend-of-the-court brief urging the US Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications. The move comes less than a month after three pharmacy chains and a wholesaler petitioned the court to rule on the issue, which has divided other federal courts (see this) and spurred the Federal Trade Commission into a Quixotic quest to urge Congress to pass a law to restrict these deals (back story). The case that precipitated these filings involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331236 Tue, 11 Jan 2011 13:26:37 +0100 4331236 http://www.medworm.com/index.php?rid=4324798&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2011%2F01%2Fis-protecting-yourself-a-joint-commission-violation%2F There are a lot of bonehead stories about the Joint Commission in the news lately. I just had to post this one. CMS and JCAHO are now investigating Lehigh Valley Hospital in Pennsylvania for using stun guns on unruly patients. In one instance, a patient was an IV pole as a pugil stick before security guards used a TASER to put him to the ground. In two other instances, patients were beating on security guards when they were “tazed.” Protecting yourself is apparently a “violation of state and federal health rules.” As a result of the stun gun incidents, the hospital was ordered to retrain certain staffers in responding to behavioral emergencies. Security and emergency department staff had to be trained in comprehensive crisis management. The hospitals also had to est... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=4324798 Sat, 08 Jan 2011 15:12:22 +0100 4324798 http://www.medworm.com/index.php?rid=4309590&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FVw459i6YkKc%2F By Daniel IkensonA Wall Street Journal editorial today shines a long overdue spotlight on an antidumping case that is emblematic of the dissonance within U.S. trade policy. I, too, wrote about this case last year as an example of how the U.S. antidumping regime undermines U.S. manufacturing, penalizes U.S. exporters, and diminishes chances for achieving the administration’s goal of doubling exports in five years. In 2005, U.S. Magnesium Corporation, the sole producer of magnesium in the United States, succeeded in convincing the U.S. International Trade Commission and U.S. Commerce Department to impose duties on imports of magnesium from competitors in Russia and China. Before toasting this outcome with some clichéd or specious utterance about how the antidumping law ensures fair trade ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4309590 Tue, 04 Jan 2011 14:07:50 +0100 4309590 http://www.medworm.com/index.php?rid=4298635&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F12%2Fjoint-commission-anti-safety-in-action%2F “Severe pain can trigger suicide in hospital ERs” the headline reads. If they’re still calling it an “ER” you already know they’re clueless. The article at the National Library of Medicine cites a new “Sentinel Event Alert” from the Joint Commission (.pdf download) urging emergency departments to be on the lookout for patients who may commit suicide in the Emergency Department. Since 1995, there have been 827 reports of patient suicides in the United States. Of those, about 14% are in non-behavioral health units, making a total of about 116 non-psychiatric inpatient suicides in 15 years.  That’s about 8 inpatient suicides per year out of 198 million inpatient days per year (644 inpatient days per 1000 population in US x 307 million US ... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=4298635 Wed, 29 Dec 2010 20:24:06 +0100 4298635 http://www.medworm.com/index.php?rid=4294820&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FjVexktE5C_U%2F Joint Commission has announced the appointment of a new Medical Director, an Internist from the University of Pennsylvania Health System, Ana Pujols-McKee, M.D. “In this role, Dr. McKee will represent The Joint Commission enterprise as she focuses on and develops policies and strategies for promoting patient safety and quality improvement in health care. Her specific responsibilities will include providing support to The Joint Commission’s Patient Safety Advisory Group; overseeing work related to the development of the Sentinel Event Policy, National Patient Safety Goals and Sentinel Event Alerts; supervising the Sentinel Event Database; and overseeing the functions of the Standards Interpretation Group and the Office of Quality Monitoring. Dr. McKee also will provide clinical gu... MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=4294820 Sun, 26 Dec 2010 13:25:38 +0100 4294820 http://www.medworm.com/index.php?rid=4285349&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZJcqK68-rK4%2F Last week, some 260 companies warned the US Securities and Exchange Commission that its proposed whistleblower program, which is mandated as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act, would transform financial fraud into a veritable “gold mine” for employees. The warning (see here) was contained in a letter from the Association of Corporate Counsel and signed by lawyers from Allergan, Arcadia Biosciences, GlaxoSmithKline, Pfizer and Onyx Pharmaceuticals among many others. The law requires the SEC to pay rewards of 10 percent to 30 percent of fines and settlements extracted from enforcement actions triggered by whistleblower claims. But the ACC argues employees will be encouraged to ignore early signs of fraud and to maximize penalties and payouts. &#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285349 Thu, 23 Dec 2010 20:27:20 +0100 4285349 http://www.medworm.com/index.php?rid=4281300&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FEndHZeya-Tg%2F By Jim HarperIs there something special about December? Perhaps it’s the spirit of giving that had the Federal Communications Commission voting yesterday to regulate Internet service. At the beginning of the month—December 1st—the Federal Trade Commission issued a report signaling its willingness to regulate online businesses. No, it’s not the fact that it’s December. It’s the fact that it’s after November. November—that’s the month when we had the mid-term election. The FCC and FTC appear to have held off coming out with their regulatory proposals ahead of the elections because the Obama administration couldn’t afford any more evidence that it heavily favors government control of the economy and society. There was already plen... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4281300 Wed, 22 Dec 2010 14:29:57 +0100 4281300 http://www.medworm.com/index.php?rid=4277813&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F-1GQ_-u9ML8%2F By Jim HarperLarry Downes has depth of knowledge and a way with words, both of which he puts to good use in this C|Net opinion piece on the FCC’s vote today moving forward with public-utility-style regulation of Internet service. If you’re interested in learning detail about the issues, it’s a good read. My favorite part is the conclusion: The misplaced nostalgia for an Internet that has long since evolved to something much different and much more useful has led to the adoption today of rules that may have a similar effect. The FCC’s embrace of open-Internet rules may indeed preserve the Internet—but preserve it in the same way amber preserves the bodies of prehistoric insects. That gloomy outcome isn’t certain, of course. Internet technology has a wonde... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4277813 Wed, 22 Dec 2010 03:21:38 +0100 4277813 http://www.medworm.com/index.php?rid=4277817&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FCjLLM0eqWBw%2F By Jim HarperThe FCC moves forward with a proposal to regulate Internet service today. It’s a bad idea. The one thing that pleases me about the ongoing debate over Internet regulation is the durability of Tim Lee’s November, 2008 Cato Policy Analysis, “The Durable Internet: Preserving Network Neutrality without Regulation.” My introduction of it is a good synopsis. The arguments against government regulation in the name of “net neutrality” have not changed: A good engineering principle is not made better if dogmatized and given to lawyers and bureaucrats to enforce as law. The FCC and its regulatory regime are almost sure to be captured by major ISPs and turned to their benefit, used to suppress competition and blunt innovation. A premise of net neutrali... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4277817 Tue, 21 Dec 2010 17:16:32 +0100 4277817 http://www.medworm.com/index.php?rid=4272601&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpAmBhLecykw%2F The controversy over the so-called pay-to-delay settlements is bubbling up to the US Supreme Court. Three pharmacy chains and a wholesaler have asked the court to review the issue because they maintain the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. The issue has become a cause celebre for the US Federal Trade Commission (look here), which has been lobbying Congress to enact legislation to restrict the settlements, and has also divided courts across the country, which is why the Supreme Court was asked to review the topic and settle the matter. The case cited by the retailers and wholesaler involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272601 Mon, 20 Dec 2010 15:41:59 +0100 4272601 http://www.medworm.com/index.php?rid=4258837&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FulyQiqtfxQo%2F By Tad DeHavenA major shortcoming of the deficit reduction plan concocted by the president’s Fiscal Commission is that it assumed that the federal government should continue doing everything it currently does. For example, the plan proposed a 15 cent per gallon increase in the federal gasoline tax to fund infrastructure projects. But why not allow the private sector to play a greater role in financing and maintaining infrastructure like roads? That’s the topic of a new Reason TV video: In the video, Bruce Benson explains that America has a strong history of privately-provided roads. Unfortunately, because government has come to dominate road construction, most citizens probably don’t stop to consider that the private sector can provide superior alternatives. As Benson points out, a ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4258837 Tue, 14 Dec 2010 16:20:22 +0100 4258837 http://www.medworm.com/index.php?rid=4249040&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FX26ttWF7AY0%2F By Tad DeHavenOver at Downsizing the Federal Government, we focused on the following issues this week: Unfortunately, the president’s Fiscal Commission appears to have operated on the premise that the federal government should continue to do everything it now does. Getting Rep. Jeff Flake on appropriations is a step in the right direction, but his appointment can’t be a token gesture. A new study finds that policymakers needn’t fear spending cuts. House Republican leaders’ support for “Prince of Pork” Hal Rogers to chair the chamber’s appropriations committee is a slap in the face of voters who demanded change in November. Michigan Gov. Jennifer Granholm, whose state’s unemployment rate is almost 13 percent, has advice for Washington on how to c... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4249040 Fri, 10 Dec 2010 21:18:35 +0100 4249040 http://www.medworm.com/index.php?rid=4233157&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FC5UQA15ub3c%2F By Julian SanchezA subcommittee of the House Committee on Energy and Commerce held a hearing last week to consider a proposal, floated in a recent Federal Trade Commission report, for “Do Not Track” legislation aimed at giving Web users greater control over how information about their online activities is collected and used by sites and advertisers. The name is a deliberate reference to the wildly popular “Do Not Call” list, a sort of virtual “No Tresspassing” sign for the telephone, which has spared scores of Americans the annoyance of telemarketers pitching FABULOUS DEALS! and LOW INTEREST RATES! during dinner. Subcommittee Chair Bobby Rush repeatedly invoked the Do Not Call program’s success in his opening remarks. And under the headline “... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4233157 Mon, 06 Dec 2010 21:57:02 +0100 4233157 http://www.medworm.com/index.php?rid=4233422&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC-wivyYh71k%2F For the past year, Watson Pharmaceutical ceo Paul Bisaro has argued the Federal Trade Commission abused its power in attempting to stop a pay-for-delay deal. And he giddily thumbed his nose at the agency by refusing to comply with a subpoena that sought to compel him to testify in connection with an investigation into the deal. Late last week, however, a federal judge burst his bubble by ruling that he failed to demonstrate” the subpoena “would be burdensome at all, let alone unduly so.” Here’s the background: in court papers, Bisaro claimed the FTC harassed Watson and used confidential FDA info to force Watson into a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. Bisaro asserted the FTC initiated its investigati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233422 Mon, 06 Dec 2010 13:34:19 +0100 4233422 http://www.medworm.com/index.php?rid=4233424&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F69Q-JUDmm-A%2F Welcome to the working week. We hope the weekend was refreshing and restful, although now, of course, the routine resumes. To prepare, we are brewing the mandatory cup of stimulation. Meanwhile, we would like to note that we are hosting a webinar on Thurs., Dec. 9 about the FDA’s Accelerated Approval process (please look here). Please join us. And now, the news of the world. Have a great day and if you run into Jeff Kindler, please send our regards… Celgene Stock Hurt By Revlimid Cancer Data (TheStreet) Elan Replaces Martin With Former Glaxo CEO Ingram (Bloomberg News) AstraZeneca Bloodthinner Gets EU Approval (Reuters) FDA Delays Decision On Benlysta Lupus Med (Associated Press) China To Lead Innovation By 2020: AstraZeneca Survey (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233424 Mon, 06 Dec 2010 12:45:55 +0100 4233424 http://www.medworm.com/index.php?rid=4233170&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FoWhkg6aROzo%2F By Daniel J. MitchellMuch to my surprise, Senate Republicans held firm earlier today and blocked President Obama’s soak-the-rich proposal to raise tax rates next year on investors, entrepreneurs and small business owners. I fully expected that GOPers would fold on this issue several months ago because Democrats were using the class-warfare argument that Republicans were holding the middle class hostage in order to protect “millionaires and billionaires.” Republicans usually have a hard time fighting back against such demagoguery, and I was especially pessimistic since every Republican senator had to stay united to block Senate Democrats from pushing through Obama’s plan for higher tax rates on the so-called rich. But the GOP surprised me earlier this year with the... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4233170 Sat, 04 Dec 2010 22:27:38 +0100 4233170 http://www.medworm.com/index.php?rid=4230152&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FoWhkg6aROzo%2F By Daniel J. MitchellMuch to my surprise, Senate Republicans held firm earlier today and blocked President Obama’s soak-the-rich proposal to raise tax rates next year on investors, entrepreneurs and small business owners. I fully expected that GOPers would fold on this issue several months ago because Democrats were using the class-warfare argument that Republicans were holding the middle class hostage in order to protect “millionaires and billionaires.” Republicans usually have a hard time fighting back against such demagoguery, and I was especially pessimistic since every Republican senator had to stay united to block Senate Democrats from pushing through Obama’s plan for higher tax rates on the so-called rich. But the GOP surprised me earlier this year with the... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4230152 Sat, 04 Dec 2010 22:27:38 +0100 4230152 http://www.medworm.com/index.php?rid=4225657&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdczYYLlP0h4%2F Once again, European Commission antitrust regulators have raided the offices of several drugmakers seeking evidence that they struck anticompetitive deals or used their dominant market positions to squeeze rivals. So far, though, only AstraZeneca has confirmed that it received a visit. “The Commission has reason to believe that the companies concerned may have acted individually or jointly, notably to delay generic entry for a particular medicine,” the commission says in a statement. This could be a potential violation of EU antitrust rules.” The focus of the raid on AstraZeneca was its Nexium heartburn med, which is a $5 billion global seller but faces generic competition across Europe. “Earlier this week, competition authorities commenced inspections at a small numbe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225657 Fri, 03 Dec 2010 13:18:40 +0100 4225657 http://www.medworm.com/index.php?rid=4219729&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F2s4Lbn3TW1Q%2F By Chris EdwardsPresident Obama’s Fiscal Commission has produced a serious and sobering analysis of the government’s budget mess, and it provides some of the needed solutions. Three of the report’s main themes are on target: the need to make government leaner, the need to cut business taxes to generate economic growth, and the need to impose tighter budget rules to discipline spending. The report rejects the view of many Democratic leaders that the welfare state built over the last 80 years must be defended against any and all budget cuts. “Every aspect of the discretionary budget must be scrutinized, no agency can be off limits, and no program that spends too much or achieves too little can be spared. The federal government can and must adapt to the 21st century by transforming it... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4219729 Wed, 01 Dec 2010 17:03:31 +0100 4219729 http://www.medworm.com/index.php?rid=4219730&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F3BFss3qvpBg%2F By Christopher PreblePresident Obama’s Fiscal Commission’s report is out and they have wisely kept military spending on the table. Having not seen the accompanying list of specific cuts, it seems that rather than micromanage DoD’s decisions with respect to which weapons systems to cut or keep, the commissioners have laid down a different marker: find the cuts that make sense, but understand that the business-as-usual of the past decade is over. The report fixes on a number of spending cuts and reforms that Benjamin Friedman and I call for in the Cato Policy Analysis “Budgetary Savings from Military Restraint” including cuts to the civilian workforce (see recommendation 1.10.4). They also hold fast to the proposition that all spending must be on the table, and reject out of ha... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4219730 Wed, 01 Dec 2010 16:46:27 +0100 4219730 http://www.medworm.com/index.php?rid=4219731&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F8QBjyJOWmSE%2F By Daniel J. MitchellThe Chairmen of President Obama’s Fiscal Commission have a new draft proposal that is filled, according to Reuters, with “sharp spending and benefit cuts.” That’s music to my ears, so I quickly flipped to the back of the report in hopes of finding hard numbers showing that the federal government will be smaller in future years. Much to my chagrin, it turns out that the federal government will increase by about $1.5 trillion between 2010 and 2020 according to the Commission’s numbers. Here’s a chart based on the data from page 57. As I explain in the video below, this disconnect between supposed spending cuts and actual spending increases is the result of politicians creating a system where a spending increase can be called a “... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4219731 Wed, 01 Dec 2010 16:44:17 +0100 4219731 http://www.medworm.com/index.php?rid=4207387&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2F3XE88GoJilw%2F Here are a few recent Joint Commission FAQ’s related to medical staff standards: Q. Are organizations required to verify affiliations at other health care organizations, and if yes, for how many years back must the verifications be done? Answer Q. Can organizations use data from outside organizations in lieu of collecting their own data to accomplish the Ongoing Professional Practice Evaluation (OPPE)?  Can outside data be used for low volume practitioners? Answer Q: Are specific privileges to administer sedation required? Answer More FAQ’s from Joint Commission regarding hospital standards. (Source: MSSPNexus Blog) MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=4207387 Mon, 29 Nov 2010 13:16:48 +0100 4207387 http://www.medworm.com/index.php?rid=4207339&cid=t_207803_109_f&fid=34761&url=http%3A%2F%2Ffeeds.feedblitz.com%2F%7E%2F22441660%2F0%2Fneuromarketing%7ENeuromarketing-Pharma-Threat.htm Some people find drug company marketing reprehensible, and apparently nobody more so than these four organizations: the Center for Digital Democracy, U.S. PIRG, Consumer Watchdog, and the World Privacy Forum. They have filed a complaint with the Federal Trade Commission accusing drug companies of everything except kidnapping and insider trading. The complaint runs to 144-pages, [...] CommentsCommentsRelated StoriesLove BrandingSubliminal MotivationAvoid the Corner of Death! (Source: Neuromarketing) Neuromarketing blogs http://www.medworm.com/rss/comments.php?id=4207339 Mon, 29 Nov 2010 11:01:32 +0100 4207339 http://www.medworm.com/index.php?rid=4197362&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU2jO9cXPUTo%2F The US Federal Trade Commission is being asked by four consumer and privacy watchdog groups to investigate what they describe as allegedly “unfair and deceptive advertising practices” that consumers confront when they attempt to gather health info online. The move comes as the FDA grapples with formulating rules for how the pharmaceutical industry can adopt social media. “Health consumers are being told that by using digital media services they have become empowered ‘e-patients,’ but they are not being informed about the privacy and potential health risks connected with the use of digital marketing of pharmaceuticals and health products,” according to the 144-page complaint filed today with the FTC by the Center for Digital Democracy, US PIRG, Consumer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197362 Tue, 23 Nov 2010 18:20:17 +0100 4197362 http://www.medworm.com/index.php?rid=4175672&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F0ca85Zl1YrE%2F By Walter OlsonI had an op-ed in the Washington Times yesterday on government’s growing participation in public-health scare campaigns demonizing everyday foods that are fattening, salty, or thought to be bad for us in other ways. In particular, I singled out Mayor Michael Bloomberg’s New York City Department of Health, which has followed up one scientifically dubious ad campaign on sweetened soft drinks (“What can we get away with?” asked one official) with an even worse — in fact, grossly misleading and manipulative — attack on salt in processed foods: It shows a can of soup bursting at the seams with table salt, whole mounds and piles of it. The city’s underlying point is not 100 percent off-base – healthful in most other ways, convention... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4175672 Wed, 17 Nov 2010 21:00:57 +0100 4175672 http://www.medworm.com/index.php?rid=4167967&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F11%2Fkeeping-patients-safe%2F A friend’s hospital recently underwent a visit from the Joint Commission. I was told that JCAHO cited them for the following infractions: Surgilube in the patient’s rooms was expired. After expiration, I’m sure that the Surgilube turns into napalm or some other dangerous chemical so this is a valid concern. There was too much Surgilube in the drawers in the rooms. After all, patients could eat the Surgilube that hadn’t transmogrified into napalm and become deathly ill from Surgilube intoxication. Tongue blades in the drawers had no expiration date. An obvious attempt to circumvent proper patient safety. Everyone knows that the emerald ash borer eggs living in the tongue blade wood mature after a tongue blade’s expiration, eat their way out of the sterile pack... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=4167967 Mon, 15 Nov 2010 16:49:19 +0100 4167967 http://www.medworm.com/index.php?rid=4159214&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FhNVhgmgURhU%2F By Jagadeesh GokhaleIt’s kudos to President Obama’s Debt Commission co-chairs for clearly outlining the gargantuan size of the fiscal problem facing the United States.  The reforms will re-direct the exploding debt trajectory downward by reforming taxes and cutting spending – reminiscent of recent fiscal reforms in the United Kingdom. Unfortunately, history is likely to repeat itself: Even if they are enacted soon — which seems unlikely — chances are bleak that we’ll stick with them for long enough to achieve their stated goals. The Debt Commission co-chairs have done a stellar job in framing the nation’s fiscal challenge and placing it squarely before the American public. The contrast between the current trajectory that increases the national debt beyond 80 percent ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4159214 Thu, 11 Nov 2010 19:44:12 +0100 4159214 http://www.medworm.com/index.php?rid=4159217&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FmZu3EjePgy4%2F By Michael F. CannonThe co-chairs of President Obama’s Fiscal Commission propose to eliminate several tax loopholes while reducing marginal rates.  Hear, hear.  But they describe those loopholes as “backdoor spending in the tax code.”  It is incorrect and dangerous to equate tax loopholes with government spending. The tax code’s countless credits, deductions, and exclusions let people keep a portion of their earnings, provided they use the money how the government wants them to use it.  Tax loopholes therefore have a lot in common with government spending: they give power to politicians, inhibit freedom, reduce economic output, unjustly enrich special-interest groups, et cetera. But to call them “tax expenditures” or “tax subsidies” or ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4159217 Thu, 11 Nov 2010 19:39:01 +0100 4159217 http://www.medworm.com/index.php?rid=4159219&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FujSpzFqXP-E%2F By Michael F. CannonFollowing up on what Dan and Chris have said … If the co-chairs of President Obama’s fiscal commission were serious about reducing federal spending and deficits, they would have proposed eliminating the federal deficit, rather than “reduc[ing] it to 2.2 percent of GDP by 2015.”  Yawn. They would have proposed cutting federal spending (currently, 24 percent of GDP and rising) to match federal tax revenue (currently at 15 percent of GDP).  But the co-chairs proposed only to “bring spending down to 22 percent and eventually 21 percent of GDP.”  Not only does that elicit another yawn, but since the co-chairs only asked for half a loaf, they won’t even get that much. If the co-chairs were serious about reducing federal spending ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4159219 Thu, 11 Nov 2010 17:55:59 +0100 4159219 http://www.medworm.com/index.php?rid=4159220&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FtgWyRvPyNqI%2F By Chris EdwardsThe co-chairs of President Obama’s National Commission on Fiscal Responsibility and Reform released a draft report yesterday on how to reduce federal budget deficits. Despite the liberal savaging the report is taking as some sort of conservative plot, its proposals are really center-left in orientation. That said, there is some good stuff in the report, which will be useful for incoming Republicans looking to tackle the budget mess. Good Ideas and Positive Directions The report provides a menu of possible spending cuts for incoming Republican members of Congress to consider, particularly Tea Party members, who proposed to cut the budget during their campaigns. The report proposes to reduce spending from 25 percent of GDP currently to 21 percent over the long run. That’s... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4159220 Thu, 11 Nov 2010 16:42:11 +0100 4159220 http://www.medworm.com/index.php?rid=4159222&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fzs-AIlTX99k%2F By Daniel J. MitchellI have many pet peeves, but one that causes me endless frustration is the Washington “spending cut” scam. This happens when politicians increase spending, but claim that they’re cutting spending because they previously had planned to make government even bigger. The proposal unveiled yesterday by the Co-Chairman of President Obama’s Fiscal Commission is a good example. If you read through their report, it sounds like there are lots of spending cuts. But they never explain that these supposed cuts are really just reductions in previously-planned increases. Here’s the bottom line. As shown in the graph, it is quite simple to balance the budget (and permanently extend all of the 2001 and 2003 tax cuts) if politicians simply limit spending gro... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4159222 Thu, 11 Nov 2010 16:02:04 +0100 4159222 http://www.medworm.com/index.php?rid=4155353&cid=t_207803_135_f&fid=35247&url=http%3A%2F%2Fmyjourneywithaids.wordpress.com%2F2010%2F11%2F11%2Fi-remember-how-grandmas-memories-stung-her%2F Although I have never been in Perth to mark Remembrance Day, my grandmother felt the loss of her brother deeply, year-round, decades after the fact when I was a kid.  My Great-Uncle Tom was killed in 1917 on the World War One battlefields of France roughly five weeks before the final assault on Vimy. My [...] (Source: My journey with AIDS) My journey with AIDS blogs http://www.medworm.com/rss/comments.php?id=4155353 Thu, 11 Nov 2010 07:04:43 +0100 4155353 http://www.medworm.com/index.php?rid=4151875&cid=t_207803_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F11%2F10%2Fhonoring-soldiers-when-they-come-home%2F Last week at the 26th annual Rosalynn Carter Mental Health Policy Symposium, I came away from the two days feeling like there are a lot of people who know and care about the issues discussed. This year’s topic was on helping returning soldiers — especially the National Guard and Reservists — reintegrate within their family, the workplace, and the community. It seems timely to talk about some of these issues to honor tomorrow, Veterans Day. The most moving stories for me came from the day’s first panel discussion, focused on the family. Ron Capps, a 25 year veteran of the U.S. Army and Army Reserves, told his story of dealing with the realities of war, and then of coming home and dealing with his feelings. “At the end of the day, I found myself categorizing mys... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4151875 Wed, 10 Nov 2010 11:15:49 +0100 4151875 http://www.medworm.com/index.php?rid=4142737&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F1dQt1jt-1WM%2F By Jim HarperThe recent European Commission proposal to create a radical and likely near impossible-to-implement “right to be forgotten” provides an opportunity to do some thinking about how privacy norms should be established. In 1961, Italian liberal philosopher and lawyer Bruno Leoni published Freedom and the Law, an excellent, if dense, rumination on law and legislation, which, as he emphasized, are quite different things. Legislation appears today to be a quick, rational, and far-reaching remedy against every kind of evil or inconvenience, as compared with, say, judicial decisions, the settlement of disputes by private arbiters, conventions, customs, and similar kinds of spontaneous adjustments on the part of individuals. A fact that almost always goes unnoticed is that a ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4142737 Mon, 08 Nov 2010 12:06:11 +0100 4142737 http://www.medworm.com/index.php?rid=4124990&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FP4EVn3DTZTY%2F By John SamplesThis morning the United States Supreme Court refused to consider the appeal in the case of SpeechNow.org v. Federal Election Commission. That’s a shame. I have written before about the SpeechNow case. Here’s a brief summary of the issues. The judiciary has long held that individuals could spend as much as they wished on elections. The traditional rationale for restricting spending — preventing corruption of the political process — did not apply to spending by individuals. If that is true, the SpeechNow plaintiffs wondered why individuals joined in a group (and independent of the candidates and parties) should not have the same freedom from restrictions. It turned out, thanks to Citizens United, that individuals did have that right to be free of limits... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4124990 Mon, 01 Nov 2010 19:09:27 +0100 4124990 http://www.medworm.com/index.php?rid=4119717&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMG3RQRES24g%2F Will Congress ever pass a bill that limits pay-to-delay deals? The Federal Trade Commission has been trying to convince Congress for months to do so, but opposition is mounting. Five Democratic Senators are objecting to a bill recently passed by the Senate Appropriations Committee because it contains a provision that would restrict these patent settlements (see this). In a letter to Senate Majority Leader Harry Reid, the endangered Nevada Democrat, and Appropriations Committee chairman Daniel Inouye, a Democrat from Hawaii, the Democrats say they have “substantive concerns with the content” of the provision and that the decision to include it in the appropriations bill “contradicts both the spirit and the letter of the Senate rules” (see the letter). Why bother to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119717 Thu, 28 Oct 2010 21:34:10 +0100 4119717 http://www.medworm.com/index.php?rid=4097902&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FvGeylL-OA40%2F By Jim HarperThe Federal Communications Commission has established a new advisory group called the “Technological Advisory Council.” Among other things, it will advise the agency on “how broadband communications can be part of the solution for the delivery and cost containment of health care, for energy and environmental conservation, for education innovation and in the creation of jobs.” This is an agency that is radically overspilling its bounds. It has established goals that it has no proper role in fulfilling and that it has no idea how to fulfill. As we look for cost-cutting measures at the federal level, we could end the pretense that the communications industry should be regulated as a public utility. Shuttering the FCC would free up funds for better purposes... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4097902 Fri, 22 Oct 2010 14:37:38 +0100 4097902 http://www.medworm.com/index.php?rid=4065613&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7xnycViW3MI%2F John Ziegler says the answer is no, but he believes Abbott Laboratories fired him in February 2006 from his job as a sales rep due to his age. At the time, he was 54 years old and so he subsequently filed a complaint with the US Equal Employment Opportunity Commission, which recently filed a lawsuit against the drugmaker. The complaint charges Abbott with “unfairly disciplining” Ziegler and “failing to properly acknowledge his successful sales performance.” And the drugmaker, the lawsuit goes on to claim, ultimately replaced Ziegler “with a less-experienced, less-educated, but much younger (then 34) sales representative who was not subjected to the same discipline and lack of acknowledgement as Ziegler.” We will update you with any reply from Abbott. UPD... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4065613 Wed, 13 Oct 2010 10:51:47 +0100 4065613 http://www.medworm.com/index.php?rid=4036735&cid=t_207803_111_f&fid=34716&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FNurseRatchedsPlace%2F%7E3%2Fvoh2rsaCFuU%2F I vaguely remember when nurses had enough time to get off the floor and meet around the old Coca-Cola machine. You could get a bottle for 10 cents back then, and you had time to drink the whole bottle before you had to go back to work. I opted to spend my time around the Pepsi machine. I like Pepsi better and the gossip was juicer around that machine. It’s important that nurses have access to Coke and Pepsi at all times. Nurses can’t function without soda. Now no one has time to leave the unit for a soda, let alone lunch or dinner. There is a nursing shortage you know and nurses barley have time to take a restroom break. And just when you think that things couldn’t get worse, in walks the Joint Commission with their big fat rulebook. Their rulebook holds the 10 Commandments ... Nurse Ratched's Place blogs http://www.medworm.com/rss/comments.php?id=4036735 Wed, 06 Oct 2010 15:20:50 +0100 4036735 http://www.medworm.com/index.php?rid=3954264&cid=t_207803_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F09%2F09%2Fprotecting-our-children-and-the-vaccine-program%2F Laraine C. Abbey, RN, CNS 09/09/2010 Vactruth.com Three minute summary presentation to: The Advisory Commission on Childhood Vaccines – 09/02/2010 Vaccine critics are saying we are trading vaccine preventable infectious diseases for chronic health disorders. How can we reasonably say, “Vaccines don’t cause or contribute to autism” when we don’t know what does cause autism!  And vaccine concerns are no longer just about Autism—they’re about children’s total health. Armies of parents are reporting that they took a normally developing child to the pediatrician for routine shots and their child’s health or behavior changed–never to be the same as before that visit.  Thousands upon thousands of parents report similar “coincidental” symptoms related in time t... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=3954264 Thu, 09 Sep 2010 14:44:17 +0100 3954264 http://www.medworm.com/index.php?rid=3946687&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT2IYaC17BMc%2F In yet another blow to the US Federal Trade Commission, a federal appeals court has refused to reconsider its ruling last April that upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals (here is the order). However, in a dissenting opinion, Justice Rosemary Pooler writes that the issue must ultimately be decided by the US Supreme Court, given the conflicting outcomes in various cases. The initial ruling by the US Second Circuit Court of Appeals was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946687 Wed, 08 Sep 2010 12:03:05 +0100 3946687 http://www.medworm.com/index.php?rid=3911776&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FIRuisqQp0ts%2F The Joint Commission is adding no new National Patient Safety Goals in 2011.  Minor revisions to existing elements of perfomance have been made, which are effective immediately. Click here for the full-text of the JC announcement.  (Source: MSSPNexus Blog) MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=3911776 Fri, 27 Aug 2010 12:47:39 +0100 3911776 http://www.medworm.com/index.php?rid=3885448&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2F5JVBxHSSCfM%2F If you’re facing an upcoming accreditation survey, you’ll want to know what the Joint Commission is reporting as the most challenging standards so far this year. Here is what is giving Hospitals and Ambulatory Care organizations the most trouble in 2010: Hospital RC.01.01.01 The hospital maintains complete and accurate medical records for each patient.  (62%) LS.02.01.20 The hospital maintains the integrity of the means of egress.  (50%) LS.02.01.10 Building and fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat.  (44%) EC.02.03.05 The hospital maintains fire safety equipment and fire safety building features.  (38%) LS.02.01.30 The hospital provides and maintains building features to protect individuals ... MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=3885448 Thu, 19 Aug 2010 12:59:39 +0100 3885448 http://www.medworm.com/index.php?rid=3876779&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FYJzOvP6n9OQ%2F Are you wondering what the Joint Commission’s thought process is for Ongoing Professional Practice Evaluation (OPPE) or whether specific privileges are required for the administration of moderate sedation?  Those and many other topics are covered under the Medical Staff section in JC’s Frequently Asked Questions. DNV  and AOA’s HFAP accreditation programs also have FAQ’s related to questions about their Accreditation and Survey Processes. (Source: MSSPNexus Blog) MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=3876779 Wed, 18 Aug 2010 09:50:14 +0100 3876779 http://www.medworm.com/index.php?rid=3865249&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FX_8p44ekc58%2F By Jim HarperA Pew Internet and American Life poll out this week finds: “By a 53%-41% margin, Americans say they do not believe that the spread of affordable broadband should be a major government priority.” Non-Internet users are less likely than Internet users to say the government should prioritize spreading access to high-speed connections. The federal government spent $7.2 billion in “stimulus” money on the premise that the federal government is supposed to do this kind of thing. And the Federal Communications Commission’s “National Broadband Plan” is premised on the idea that there is supposed to be a national broadband plan. It isn’t, and there’s not. Much as I love using the Internet for work, entertainment, and social connectio... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3865249 Fri, 13 Aug 2010 18:55:59 +0100 3865249 http://www.medworm.com/index.php?rid=3865456&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVdgbM3QaGSA%2F For months, US Federal Trade Commission commish Jon Leibowitz has argued that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save consumers billions of dollars over the next decade (back story). He has pointed to a Congressional Budget Office study forecasting nearly $2 billion in savings over 10 years and an FTC study that estimates savings of $3.5 billion annually. And he has maintained restrictions would speed the arrival of low-cost generics by more than a year onto pharmacy shelves. Now, a new study claims the CBO report “is flawed and likely substantially overestimates the budgetary savings,” and also claims that restrictions may have the opposite effect. “Under many circumstances, reverse payment patent settlemen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865456 Fri, 13 Aug 2010 15:28:09 +0100 3865456 http://www.medworm.com/index.php?rid=3806023&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7SvmpDcngfs%2F In yet another legislative bid to tackle pay-to-delay deals, the US Senate Appropriations Committee voted yesterday to pass the Preserve Access to Affordable Generic Drugs Act, which was included in the Financial Services and General Government Appropriations bill reported out of the committee. A companion House bill was recently passed as part of the Supplemental Appropriations Act of 2010. The Congressional Budget Office estimates the House bill would save the federal government $2.6 billion over 10 years by reducing drug costs. “The cost of brand-name drugs rose nearly ten percent last year. In contrast, the cost of generic drugs fell by nearly ten percent. At this time of spiraling health care costs, we cannot turn a blind eye to these anticompetitive backroom deals that deny consume... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806023 Fri, 30 Jul 2010 13:06:17 +0100 3806023 http://www.medworm.com/index.php?rid=3802587&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsYwntWuqtGs%2F Despite various legislative and courtroom setbacks, FTC commish Jon Leibowitz insists there is reason to be optimistic that so-called pay-to-delay deals may soon be a thing of the past. In testimony this week before the House Committee on the Judiciary’s Subcommittee on Courts and Competition Policy, he appeared to see blue skies on his horizon and went so far as to say the ‘tide may be turning.’ For instance, he cited a recent ruling by the US Second Circuirt Court of Appeals, which actually upheld the legality of pay-for-delay deals, but at the same time, took the unusual step of inviting entities that purchase drugs and had challenged a particular deal to ask for that case to be reviewed by the full circuit, citing the “exceptional importance” of the antitrust impl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3802587 Thu, 29 Jul 2010 12:47:40 +0100 3802587 http://www.medworm.com/index.php?rid=3795055&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_tKJw58uuGI%2F Here’s a question for you: if a company wants to convince regulators that it did nothing wrong in connection with an investigation, should the company cooperate or should the company provide misleading info in hopes of throwing them off any perceived scent? The European Commission says Servier somehow made the wrong choice. And so the EC has charged Servier and Les Laboratoires Servier with providing bad info to the agency, which is seeking evidence that drugmakers in several countries struck anticompetitive deals to stall cheaper generic versions of their own meds after patents had expired or used their dominant market positions to squeeze rivals. EU regulators have said they suspected that Servier did deals with generic rivals Krka, Lupin, Matrix, Niche Generics and Teva to thwart ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795055 Tue, 27 Jul 2010 12:45:04 +0100 3795055 http://www.medworm.com/index.php?rid=3780352&cid=t_207803_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FAP2Nf2gpfH4%2F By Robin Strongin. It didn’t receive much attention in the context of oil wells being capped and financial services legislation being passed, but the Federal Communications Commission (FCC) took a step last week that could make a profound difference for Americans who live in rural parts of the country. The FCC voted unanimously to have the federal government pay a greater share of broadband Internet costs for rural health care providers, and the commission also expressed its intent to subsidize the construction of broadband networks. Why is this important?  Over the past 25 years, according to the Center for Health Transformation, over 500 rural hospitals have shuttered their facilities.  And, while 25 percent of the U.S. population lives in rural areas, only about one in ten doctors ... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3780352 Thu, 22 Jul 2010 15:31:39 +0100 3780352 http://www.medworm.com/index.php?rid=3780453&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FDpcxfm2UXno%2F Prior to providing care, treatment, and services, the hospital obtains or renews orders (verbal or written) from a licensed independent practitioner. Sounds like a no-brainer right?  How difficult can it be for hospitals to comply with such a simple standard? Turns out, pretty difficult.  Nearly every hospital struggles to comply with at least one aspect of that simple-sounding CMS/Joint Commission requirement in today’s highly-mobile society.  Each day around the country, patient’s show up at hospitals wth orders for various laboratory or radiology studies.  If the physician or advanced practice nurse practices at the hospital, there’s no question that he or she is a licensed independent practitioner; the records are right there, usually available with just a... MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=3780453 Thu, 22 Jul 2010 13:57:07 +0100 3780453 http://www.medworm.com/index.php?rid=3767314&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVAkuw91uRH4%2F Two months ago, Paul Bisaro, the ceo of Watson Pharmaceuticals, made a sensational charge against the Federal Trade Commission - in court papers, he accused the agency of abusing its power in attempting to stop pay-for-delay deals. Bisaro claimed the FTC harassed his company and used confidential FDA info to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767314 Mon, 19 Jul 2010 12:23:08 +0100 3767314 http://www.medworm.com/index.php?rid=3733092&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F07%2Fwtf-moment-897%2F Nurse [as she was walking out of the Dirty Utility room]: “Where’s the timer for the pregnancy tests?” Secretary: “Oh, the lady from lab threw it out. It was expired.” Nurse: “Wait. She came to our department and threw something in our department out? And she said that the timer expired?” Secretary: “Yeah. She said that it could be a JCAHO violation if we were using an expired timer.” Nurse: “It’s a f**king clock. How does a clock expire?” Secretary: “Ask the ‘Lab Nazi.’” We have to keep a timer in the Dirty Utility Room (which happens to be one of the many ROOMS in the emergency DEPARTMENT) so that pregnancy tests are read at precisely 3 minutes. If they are not read at 3 minutes, that could be... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=3733092 Wed, 07 Jul 2010 14:14:43 +0100 3733092 http://www.medworm.com/index.php?rid=3733154&cid=t_207803_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fstandards-naming-medical-devices Discussion of medical device issues has become part of the mainstream press such as last week's Boston Globe article about their security.   A year ago, I wrote about a breakthrough in medical device interoperability standards for content, vocabulary and transmission.   (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3733154 Wed, 07 Jul 2010 13:15:23 +0100 3733154 http://www.medworm.com/index.php?rid=3733299&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVqaktbBtXWI%2F Last week, the Florida Medical Examiners Commission released its most recent report on the number of drug-related deaths in the state. The sad bottom line is that 8,653 - out of more than 171,300 deaths overall - were attributed to a drug that was listed as a cause of death, according to toxicology reports. Data was collected on various drugs, including benzodiazepines; cannabinoids; cocaine; ethyl alcohol; gamma-hydroxybutyric acid; methylated amphetamines (including Ecstasy); and various opioids, including fentanyl, heroin, methadone, morphine and oxycodone (read the report). However, one class of drugs that has, unfortunately, been associated with deaths, specifically suicide, is not included - antidepressants. Despite curiosity over this omission, Florida officials say there is a reaso... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3733299 Wed, 07 Jul 2010 12:06:11 +0100 3733299 http://www.medworm.com/index.php?rid=3730095&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyREbKSL71QY%2F A watchdog group has asked the Federal Trade Commission to investigate contract pricing arrangements that Merck and Sanofi-Pasteur offer physician practices. In a letter to the FTC, the Citizens for Responsibility and Ethics in Washington allege the vaccine makers offer docs significant discounts, but only after signing contracts prohibiting them from purchase vaccines made by rivals. To make its case, CREW cites memos and emails written by four different physician groups in which its doctors are reminded to purchase only vaccines from Sanofi-Pasteur or Merck if they want to obtain the best prices. The vaccines include Merck’s Gardasil for HPV, Rotateq for rotavirus, and Recombivax for hepatitis B, while the Sanofi vaccines include several products, notably Menactra for meningitis. C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730095 Tue, 06 Jul 2010 15:25:47 +0100 3730095 http://www.medworm.com/index.php?rid=3730096&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLnS1R8Akp9w%2F That’s the implication of a new survey released by the European Union, whose antitrust regulators have been raiding drugmakers in several countries seeking evidence they struck anticompetitive deals or used their dominant market positions to squeeze rivals. Last year, EU competition commissioner Neelie Kroes issued a report saying delays in bringing generic drugs to market cost consumers and healthcare providers billions (back story here and here). Now, the EU says the number of patent settlements that are “potentially problematic” under EU antitrust rules fell to 9, or 10 percent of 93 such deals between July 2008 and December 2009 compared with 45, or 22 percent of the 207 deals in the period covered in last year’s inquiry, which was January 2000 to June 2008. And... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730096 Tue, 06 Jul 2010 13:46:31 +0100 3730096 http://www.medworm.com/index.php?rid=3723371&cid=t_207803_118_f&fid=34702&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmspblog%2F%7E3%2FwRHR7cbZOfg%2F The Joint Commission has released partial pre-publication standards updates for 2011, which will remain available on their web site until October 1, 2010.    The currently available pre-pubs include:   Hospital and Critical Access Hospital Standards – Language for the long-awaited MS.01.01.01 regarding Bylaws requirements - Effective March 31, 2011  Hospital Standards – Patient Centered Communication, which sets requirements for interpreters and translators for non-English speaking patients, as well as effective communication methods for patients with vision, speech, hearing, or cogitive impairments. – Effective January 1, 2011  Behavioral Health Standards - Revisions to the Care, Treatment and Services Chapter - Effective January 1, 2011  http://www.join... MSSPNexus Blog blogs http://www.medworm.com/rss/comments.php?id=3723371 Sat, 03 Jul 2010 11:56:35 +0100 3723371 http://www.medworm.com/index.php?rid=3721960&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F28WlTkAyHMw%2F A proposal to end those controversial ‘pay-to-delay’ deals between brand-name and generic drugmakers was passed by the House of Representatives last night as part of a measure to fund wars. Ironic, yes? Or maybe appropriate. In any event, the bill now goes to the Senate, Bloomberg News reports. Under the proposal, drugmakers could be fined if the Federal Trade Commission or the courts determine they struck deals to preserve a brand-name drug patent by delaying introduction of a lower-priced generic equivalent (see page 74). This is “just another signal of the growing support in Congress for ending this unconscionable behavior by some pharmaceutical companies,” FTC chairman Jon Leibowitz tells the news service. The FTC, you may recall, has made a mission of ending these dea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721960 Fri, 02 Jul 2010 12:55:23 +0100 3721960 http://www.medworm.com/index.php?rid=3718382&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FsPvhQSrvB5M%2F By Daniel J. MitchellMany people assume that Europe is the land of high-tax welfare states and America is an outpost of laissez-faire capitalism. We should be so lucky. The burden of government in America is still lower than it is in the average European nation, but the United States is a lot closer to France than it is to Hong Kong — and the trend is not comforting. We recently endured the embarrassing spectacle of President Obama arguing with Europeans that they should increase the burden of government spending. Now we have a new report from the European Commission indicating that the average corporate tax rate in member nations of the European Union has plummeted to just 23.5 percent while the corporate tax rate in the U.S. has stagnated at 35 percent. In the past dozen years a... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3718382 Thu, 01 Jul 2010 15:10:33 +0100 3718382 http://www.medworm.com/index.php?rid=3699706&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAM2Nw1RqLtc%2F Rejecting an appeal, the Federal Competition Commission voted 4 to 1 to fine the companies $11.6 million for conspiring to raise prices of meds sold to a social-services agency, Instituto Mexicano del Seguro Social, according to this statement. The decision comes shortly after the antitrust regulator indictated new investigations may be launched into drugmakers for scheming to inflate prices (background). According to the CFC, the drugmakers engaged in monopolistic practices during public bidding organzied by the agency and, in doing so, eliminated competition, which forced the IMSS, as its known, to pay artificially high prices. Those fined include Eli Lilly, Laboratorios Cryopharma, Probiomed, Fresenius Kabi Mexico, Baxter and Laboratorios Pisa. The meds involved were insulin and injecta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699706 Fri, 25 Jun 2010 12:03:59 +0100 3699706 http://www.medworm.com/index.php?rid=3695662&cid=t_207803_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Femr-usability-let-market-decide   .fullpost{display:inline;}As any left-handed person that has struggled to use a pair of scissors or a fountain pen will verify, the design of a tool impacts the quality of the work done with that tool. That’s true for electronic health records, as well. EMRs support complex cognitive processes, and the way they are designed directly impacts the speed and accuracy of a clinician’s work. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3695662 Thu, 24 Jun 2010 17:18:09 +0100 3695662 http://www.medworm.com/index.php?rid=3683626&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F06%2Fmore-serious-offenses%2F Following up on my previous post about Joint Commission micromanagement, we got word of another big “no-no” according to JCAHO’s rules. We have now been informed that according to Joint Commission rules, in association with EPA studies, there is entirely too much drug contamination in the nation’s water supplies. Therefore, hospitals must now separate waste into multiple bins and dispose of such waste appropriately in order to avoid being fined by the EPA and sanctioned by JCAHO. And JCAHO will go through the garbage during its inspections to make sure that you are complying with the rules, too! Regular waste goes into a blue bag. Blue bags comprise most of the waste in the hospital. “Hazardous waste,” must be put it into a black hazard bag. Hazardous me... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=3683626 Mon, 21 Jun 2010 10:01:26 +0100 3683626 http://www.medworm.com/index.php?rid=3671714&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F06%2Fserious-offenses%2F Remember the movie Rainman where Dustin Hoffman whipped out his red book and wrote on his “Serious Injury List” how Charlie Babbitt “squeezed and pulled and hurt my neck“? If not, you have to rent that movie and watch it. One of my favorite all time movies. Well, the lab supervisor recently descended upon the emergency department with her notebook of Serious Offenses in hand. “Where’s the tech named ‘Maryann’?” “She’s not here today.” “I need to speak to her immediately.” “What’s the problem?” “She wrote the results of a patient’s pregnancy test on a patient’s chart, initialed them … AND SHE’S NOT QUALIFIED TO READ PREGNANCY TESTS! The Joint Commission will se... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=3671714 Thu, 17 Jun 2010 19:50:44 +0100 3671714 http://www.medworm.com/index.php?rid=3648802&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEpJ0J1P_UBk%2F Hello, everyone. Nice to see you again. A spot of rain is falling here on the Pharmalot corporate campus, but our spirits remain sunny. We look forward, in fact, to a productive day filled with interesting items and interesting meetings. Hopefully, your day will be as fruitful. To help you along, here are some snippets from the news of the world. Have a good one… Hospira Approved For 2nd Biogeneric (Reuters) CVS Will Eliminate Walgreen From PBM Network (Associated Press) Glaxo Buys Argentine Drugmaker (Reuters) Senators Press FTC On Watson Allegations (Dow Jones) Glaxo Says Reports Of Irish Ops Review Are Inaccurate (InPharmaTechnologist) Human Genome Says Cancer Drug Failed To Improve Survival (Reuters) Unitaid Launches Patent Pool For HIV/AIDS Drugs (ICTSD) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648802 Thu, 10 Jun 2010 11:44:18 +0100 3648802 http://www.medworm.com/index.php?rid=3633443&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F_oIAG9JbdRY%2F By Daniel J. MitchellIt’s rather symbolic of what’s wrong with Washington that a commission ostensibly created to promote deficit reduction is seeking a bigger budget, as noted in the Tax Notes story excerpted below. Rather than impose a bigger burden on taxpayers, though, I will generously suggest that they could easily fulfill their mandate by perusing Cato’s Downsizing Government website. And if they really want to do the right thing, they can always just look at Article I, Section VIII, of the Constitution and get rid of existing programs and activities that are not enumerated powers of the federal government. Saddled with a tight deadline and great expectations, members of President Obama’s deficit reduction commission say they may not have the resources necess... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3633443 Sun, 06 Jun 2010 13:47:11 +0100 3633443 http://www.medworm.com/index.php?rid=3621951&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff7mnT2ghmmk%2F In its latest report to Congress, the US Securities and Exchange Commission’s Office of Inspector General never mentions Dendreon by name, but sources tell us the agency probe into allegations of market manipulation and a “bear raid” into an unnamed “manufacturer” do, indeed, concern the maker of the celebrated Provenge prostate cancer vaccine that was recently approved by the FDA (background). The investigation was opened last summer and the SEC’s OIG last report to Congress noted that a complaint was filed “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug.” The newest OIG report says the probe into the trading ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621951 Wed, 02 Jun 2010 13:30:25 +0100 3621951 http://www.medworm.com/index.php?rid=3621658&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FjE7Biud9oeU%2F By Jim HarperLast week, I referred obscurely to “folks wanting to install the FCC as the Internet’s regulator,” cautioning that this same Federal Communications Commission is our national censor. A friendly correspondent points me to an article in Ars Technica about the demand for speech controls coming from the same groups that want the FCC to control the Internet’s infrastructure, groups such as Free Press, the Media Access Project, and Common Cause. Is there a parry to the charge that this is a demand for censorship? The signatories to the regulatory filing “respectfully request[] that the FCC . . . inquire into the extent and effects of hate speech in media, and explore possible non-regulatory ways to counteract its negative impacts.” The filing doe... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3621658 Tue, 01 Jun 2010 17:43:50 +0100 3621658 http://www.medworm.com/index.php?rid=3607817&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTSbBPhHxMwU%2F Here’s a sensational accusation for you. Paul Bisaro, the ceo of Watson Pharmaceuticals, filed papers in federal court the other day accusing the Federal Trade Commission of abusing its power in attempting to stop pay-for-delay deals, which the agency argues are anti-competitive and, therefore, harm consumers (see background). Bisaro claims the FTC harassed his company and used confidential FDA info in an effort to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. His charge follows a subpoena sought last year by the FTC to compel Bis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3607817 Thu, 27 May 2010 18:06:48 +0100 3607817 http://www.medworm.com/index.php?rid=3607485&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FNsFlrbiXSNI%2F By Jim HarperAmid charge and countercharge about who is shilling for whom in the debate over Internet regulation, Peter Suderman has the right focus in a short piece on Reason’s Hit & Run blog. The Federal Communications Commission’s Chairman is claiming that he only wants to regulate the Internet’s infrastructure, but one of his colleagues, Commissioner Michael Copps, is non-denying that he wants to censor the Internet. There may be exceptions, but it’s usually pretty safe to assume that anytime a politician or bureaucrat dodges a question while calling for “a national discussion about” the proposal at hand, what he or she really means is, “I want to indicate that I support this idea without actually going on record as supporting it.” Th... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3607485 Thu, 27 May 2010 15:43:17 +0100 3607485 http://www.medworm.com/index.php?rid=3599738&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOgrZm0fTE7A%2F Rise and shine. Another day awaits. And who knows what lies ahead? Meetings? Deadlines? Unexpected tidbits of information? We can relate. So grab a cup of stimulation - or perhaps, a bottle of water, since it will be rather sticky today in the greater Pharmalot metropolitan region - and dive in. As always, here are some items to ease the process. Have a great day everyone and stay in touch… UK’s NICE Won’t Cover Bayer Liver Cancer Drug (Bloomberg News) AMRI Cuts US Workforce 10% And Shifts Jobs To Asia (OutsourcingPharma) FTC Commish Remains Bullish On Ending Pay-To-Delay Deals (PharmaTimes) Dennis Quaid Sues Baxter Over Heparin Overdose (USA Today) Merck Will Not Raise Its Dividend (Associated Press) Sanofi-Aventis Will Reassign Global Media Ad Duties (MM&M) Photo t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599738 Wed, 26 May 2010 11:48:29 +0100 3599738 http://www.medworm.com/index.php?rid=3603598&cid=t_207803_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhealth-insurance-and-medical-loss-ratio-foolishness%2F2010.05.25 Like Ezra Klein, smart people keep saying foolish things about the health insurance business. This time it’s a pair of bloggers talking about the largest expense that health insurers face — their “medical loss ratio.” According to Richard Dale at the Venture Cyclist: [W]hy do they call it Medical Loss Ratio? Why is looking after me (or you) called “Medical Loss,” when the whole point of a healthcare system is to look after me (or you)? (Sigh.) Alan Katz, one of the leading health insurance bloggers, surprisingly links to this with approval, saying “words matter.” The problem? The word “loss” is probably one of the four oldest words in the insurance industry. I’d say the others are probably “premium,” “commission,” and “profit.” Should we start outlawi... Better Health blogs http://www.medworm.com/rss/comments.php?id=3603598 Wed, 26 May 2010 01:00:39 +0100 3603598 http://www.medworm.com/index.php?rid=3585593&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FlcBbCg8vZf8%2F By Daniel IkensonIn honor of World Trade Week—and for its decreed purpose of educating Americans about trade—this post is about U.S. trade policy working at cross-purposes with other policies or goals of the administration. So numerous are these examples of trade policy dissonance, that a committed wonk could devote an entire website to the task of documenting them. If the administration were serious about making trade policy work—rather than just paying it lip service—it would compile its own exhaustive list of laws, regulations, policies, and practices that actually undermine its stated objectives of facilitating economic growth, investment, and job creation through expanded trade opportunities. Then, it would make the changes necessary to ensure that our policies are paddling in... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3585593 Thu, 20 May 2010 21:11:06 +0100 3585593 http://www.medworm.com/index.php?rid=3577626&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh_IpIo82H4Y%2F A federal appeals court last month may have upheld the legality of pay-for-delay deals that thwart the introduction of generics, but the issue isn’t dead yet. A group of consumers, union health and welfare funds, which have been certified as a class, are asking a California appeals court to review the same set of circumstances involving Bayer, Barr Pharmaceuticals and the Cipro antibiotic. At issue in both cases is a deal in which Bayer paid Barr, now owed by Teva Pharmaceuticals, to drop its 1991 patent challenge to Cipro. In 1997, Barr struck a deal with Bayer just two weeks before a lawsuit was set to go to trial, delaying the entrance of a generic version. The US Second Circuirt Court of Appeals ruled the deal was kosher (see here), although the Federal Trade Commission continues... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577626 Wed, 19 May 2010 12:11:47 +0100 3577626 http://www.medworm.com/index.php?rid=3573939&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzo7NBIKNNso%2F How gloomy is the outlook among pharma execs? A new survey finds 82 percent predict big drugmakers won’t be able to innovate sufficiently internally to replenish their dwindling pipelines. And this deperation will lead to still more acquisitions - 68 percent believe substantial acquisition activity will occur within the next two years and 19 percent anticipating “major activity” within the next year. Those who believe the glass is half full think the improved economic situation means pharma should have confidence to proceed with mergers - 63 per cent think the climate for doing business and access to funding have improved in the past year. The survey of 381 pharma execs was just released by Marks & Clerk, a large patent law firm in the UK, so it’s hard to know ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573939 Tue, 18 May 2010 15:55:58 +0100 3573939 http://www.medworm.com/index.php?rid=3569791&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F4VhUqDbTis8%2F By Jim HarperThe New York Times starts its commentary on proposed Internet regulations with a clever ad hominem argument: “The Republican attack on the Federal Communications Commission’s proposal to classify broadband Internet access as a telecommunications service sounded a lot like the G.O.P. talking points on health care reform.” The GOP are being like themselves. Accordingly, Times readers should think their viewpoint is yucky. It’s not the most substantive argument you’ll come across today. There are good reasons not to encumber the Internet with regulations designed for the telephone system. Here are four: The Internet is not like the telephone system, and the FCC  doesn’t have the institutional ability to manage a changing, competitive system o... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3569791 Mon, 17 May 2010 14:25:00 +0100 3569791 http://www.medworm.com/index.php?rid=3556101&cid=t_207803_88_f&fid=38959&url=http%3A%2F%2Fwww.epmonthly.com%2Fwhitecoat%2F2010%2F05%2Fguaiac-issues%2F JCAHO apparently requires that the doctors show nurses results of all hemoccult testing. I can’t find the actual requirement anywhere, but then again, JCAHO hides its patient safety requirements and makes anyone who wants to learn about patient safety purchase their books. In addition, whomever interprets the test must take a certifying exam every year to show that they are able to properly interpret the color change on the hemoccult card. Kind of like taking a certifying exam each year to prove that you can determine when a traffic light turns from green to red, I suppose. Apparently physicians are competent enough to manage a multi-trauma patient, intubate, insert chest tubes, and calculate the doses for vasoactive medications, but, on that same multi-trauma patient we lack the fun... WhiteCoat's Call Room blogs http://www.medworm.com/rss/comments.php?id=3556101 Wed, 12 May 2010 15:03:47 +0100 3556101 http://www.medworm.com/index.php?rid=3552431&cid=t_207803_125_f&fid=34820&url=http%3A%2F%2Fwww.dentalblogs.com%2Farchives%2Fadministrator%2Fyour-dental-team-wants-money-respect%2F “Dental Assisting Digest” compiled the top ten things dental assistants want their dentists to know. At the top of the list? You guessed it. Compensation. Assistants want to be paid well for their work. But how can you pay out when money isn’t coming in, at least not like it used to? Let’s see what the experts have to say about it… Linda Miles, formerly of Linda Miles & Associates and creator of Speaking and Consulting Network, says that 70% of dental practices have reduced hours, laid off employees, cut benefits, or put a freeze on raises. In “Times are tough – no raises this year,” Linda tells us that salary increases for dental professionals may not happen this year because of our lagging economy. She says that merit raises are a much better option than cost of livin... dental blog for dentists about dentistry blogs http://www.medworm.com/rss/comments.php?id=3552431 Tue, 11 May 2010 14:24:51 +0100 3552431 http://www.medworm.com/index.php?rid=3538075&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FZqxmoUScElE%2F By Walter OlsonI’m usually in enthusiastic accord with our friends over at the Competitive Enterprise Institute, but it seems to me they’ve made a mistake by petitioning the Federal Trade Commission (FTC) to crack down on GM’s ridiculous “we repaid our federal loan” ad. Some zealous enforcers would love for the FTC to do more to regulate speech by American business on matters of public concern, and it seems to me the last thing we should do is encourage such a trend. For those who came in late, General Motors and its CEO Ed Whitmire were widely and rightly assailed here and elsewhere for asserting (in a column whose message was repeated in much-played TV ads) that the company had repaid its bailout loan “in full, with interest, years ahead of schedule.&#... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3538075 Wed, 05 May 2010 19:11:47 +0100 3538075 http://www.medworm.com/index.php?rid=3519709&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLrxAf4BduMM%2F In a blow to the Federal Trade Commission, the US Second Circuirt Court of Appeals has upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals. But at the same time, the court suggested the issue needed further review (see the ruling). The ruling was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owed by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was set to go to trial. The ruling is yet another setback for the Federal Trade Commission, which has been pushing aggressively to end pay-to-delay deals (look here). Two months ago, a federal judge dismissed an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519709 Fri, 30 Apr 2010 12:17:52 +0100 3519709 http://www.medworm.com/index.php?rid=3499049&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fwa-L6rBh0XI%2F By Mark A. CalabriaThere has been much speculation that the Securities and Exchange Commission (SEC) released its charges against Goldman Sachs on the eve of a Senate vote on new finance regulation in order to help Democrats win that vote.  Perhaps that theory is wrong: It now looks more likely that the SEC timed its Goldman case in order to divert attention away from two SEC inspector general (IG) reports criticizing the commission. In one of the reports, the SEC IG found that several of the top staffers at the SEC were spending their days surfing the web for porn, rather than looking for securities fraud.  One senior manager spent almost 8 hours a day looking a porn, getting to the point where he even filled up his government issued hard-drive with porn.  His actions were not ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3499049 Fri, 23 Apr 2010 16:09:52 +0100 3499049 http://www.medworm.com/index.php?rid=3490622&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FYcRga91QNG4%2F By Jim HarperA few weeks ago, the Court of Appeals for the D.C. Circuit rejected the FCC’s claim of authority to regulate Internet service. That was good news—and it sure didn’t create a crisis. It meant that the FCC would have to get authority from Congress if it wanted to regulate the Internet. But a little hiccup in that plan quickly emerged: Congress won’t let the FCC regulate the Internet. Bills to do that have been floating around Capitol Hill for years, and they’ve never gotten traction. So the proponents of government-controlled Internet access services have worked up an end-run around Congress: They want the FCC to try to reclassify Internet access from an unregulated “information service” to a “telecommunications service,” su... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3490622 Tue, 20 Apr 2010 18:45:01 +0100 3490622 http://www.medworm.com/index.php?rid=3475806&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FOfx9jPsfRDQ%2F By Timothy B. LeeI haven’t been following the debate over Sen. Dodd’s financial overhaul closely enough to have an opinion on the overall package, but Mike Masnick flags one aspect of the legislation that seems really troubling. Bob Litan explains: Under existing law, startup companies can raise money easily and quickly from “accredited investors” — individuals with substantial wealth or income. There is no need for the companies or the investors to gain approval from any state or regulatory official. All of this would change if Section 926 of the Dodd bill is included in any final reform legislation. That section would require, for the first time, companies seeking angel investment to make a filing with the Securities and Exchange Commission, which would hav... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3475806 Fri, 16 Apr 2010 12:32:31 +0100 3475806 http://www.medworm.com/index.php?rid=3463681&cid=t_207803_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fhealthcare-reform-and-hit I recently planned a speaking engagement and was warned to avoid healthcare reform commentary - too controversial and too emotionally charged. Regardless of your politics, some aspects of healthcare reform are not controversial. Here's a list of health information technology tactics included in healthcare reform. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3463681 Tue, 13 Apr 2010 13:01:52 +0100 3463681 http://www.medworm.com/index.php?rid=3443674&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F4JTBrNJycos%2F By Jim HarperIn the wake of today’s ruling in the D.C. Circuit that the FCC had exceeded its authority in attempting to regulate access to the Internet, I did a number of radio interviews and a radio debate with Derek Turner of Free Press, a leading advocate of Internet regulation. The debate was a brief, fair exchange of views. I was struck, though, to hear Turner refer to the situation as a “crisis.” Sure enough, in a Free Press release, Turner says three times that the ruling creates a “crisis.”  Recall that in 2007 Comcast degraded the service it provided to a tiny group of customers using a bandwidth-hogging protocol called BitTorrent. Recall also that before the FCC acted, Comcast had stopped doing this, relenting to customer complaints, negat... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3443674 Wed, 07 Apr 2010 02:29:18 +0100 3443674 http://www.medworm.com/index.php?rid=3420440&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FbFIoPFz5zs0%2F By Tad DeHavenThe USPS has taken the first step toward reducing mail delivery to five days a week by sending a request to the Postal Regulatory Commission. However, it will be ultimately up to Congress whether or not Saturday delivery is eliminated. The USPS, which is in a death spiral, views the elimination of Saturday mail delivery service as a step toward regaining its financial footing. Not surprisingly, the decision is proving controversial among some members of Congress. Here’s a better idea: give Americans the freedom to choose the mail services they want by repealing the USPS monopoly. That way consumers and businesses could choose to provide and use mail services zero days a week or seven days a week. Online movie rental services like Netflix offer a small example. A lot of folk... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3420440 Mon, 29 Mar 2010 19:47:30 +0100 3420440 http://www.medworm.com/index.php?rid=3398891&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FjRIfgHvCGxE%2F By Daniel J. MitchellGreece’s fiscal disarray is a visible manifestation of Europe’s future, but the most appropriate symbol of what’s wrong with the continent comes from Brussels, where there are three “presidents” fighting over the right to represent Europe at international gatherings. The contestants include the President of the European Commission, the President of the European Council, and the European Union President (which rotates every six months among different national leaders). While these three personalities fight over who gets to sit where and shake hands first, the real problem is that they all agree that government should be bigger, taxes should be higher, and power should be more centralized as part of the effort to create a superstate in Bruss... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3398891 Tue, 23 Mar 2010 19:47:22 +0100 3398891 http://www.medworm.com/index.php?rid=3382796&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FT8OxLguD9zw%2F By Jim HarperWriting on the TechLiberationFront blog, Berin Szoka warns of the extensive Internet regulation that could come with huge grants of authority to the Federal Trade Commission in H.R. 4173, the “Wall Street Reform and Consumer Protection Act of 2009.” Congress is about to reinvent the FTC as the “National Nanny” it was well on its way to becoming back in the 1970s.  Today, the FTC is not merely the general overseer of our economy, but the key regulator of the Internet.  If the Senate passes Rep. Frank’s bill with its so-called “improvements” to the FTC Act, future generations will look back and wonder why, without even taking the time to consider what it was doing, Congress radically transformed Internet governance as an afterthought to financial regulat... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3382796 Fri, 19 Mar 2010 14:53:09 +0100 3382796 http://www.medworm.com/index.php?rid=3378729&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl_d81VsC3bA%2F The amendment was dropped from part of the health care reform bill because of concerns it wouldn’t pass muster with congressional rules, according to a spokeswoman for Senator Herb Kohl, a Wisconsin Democrat who chairs the Special Committee on Aging, which yesterday held a hearing on drug prices. The proposal was vigorously supported by the Federal Trade Commission, which argues that so-called pay-to-delay deals hurt consumers by delaying the launch of lower-cost generics (background here). The proposed amendment would have made it harder for brand-name drugmakers to settle patent challenges brought by generic companies. Kohl plans to pursue the ban after health care reform is settled, according to The Wall Street Journal. Kathleen Jaeger, president the Generic Pharmaceutical Associ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3378729 Thu, 18 Mar 2010 12:39:38 +0100 3378729 http://www.medworm.com/index.php?rid=3374082&cid=t_207803_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F03%2Fsimple-lesson-for-health-it-industry.html From an Op Ed "Living with the Electronic Car" in today's Wall Street Journal:"A Toyota executive recently explained to a Congressional committee investigating claims of uncontrolled acceleration: "We need to reduce the number of things we ask our customers to do correctly." In fact, the exec was describing the essence of responsible engineering - though perhaps the balance in auto design has gotten out of whack."Considering the feedback from physicians on the needless complexity of electronic medical records and other computerized medical devices for example at "An Honest Physician Survey on EHR's", it seems the healthcare IT industry has yet to learn this simple lesson.I'm frankly not convinced there's "anyone home" in this complexity-loving industry who could fathom such advice as a goo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3374082 Wed, 17 Mar 2010 15:39:00 +0100 3374082 http://www.medworm.com/index.php?rid=3370399&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FTWFjZgHYkas%2F By Jim HarperIn a highly symbolic gesture, the Federal Communications Commission published the executive summary of its “National Broadband Plan” in one of the most opaque formats going: It’s a PDF scan of a printed document. This means you can’t cut and paste the bullet point that says: “Increase civic engagement by making government more open and transparent, creating a robust public media ecosystem and modernizing the democratic process.” Can an agency that publishes documents in inaccessible formats be relied on to deliver transparency? Did you know that this is Sunshine Week?! Let’s segue from symbolism to substance . . .  That bullet and the many that accompany it explode the FCC’s proper authority and propose an industrial policy f... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3370399 Mon, 15 Mar 2010 19:19:41 +0100 3370399 http://www.medworm.com/index.php?rid=3366181&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FqzETmFTvV34%2F By David RittgersAs I wrote in this post, Senators McCain and Lieberman proposed a broad piece of anti-terrorism legislation. The Enemy Belligerent, Interrogation, Detention, and Prosecution Act of 2010 would use military detention to incapacitate suspected domestic terrorists, including American citizens. This is a sea change in counterterrorism policy and a break from American principles that mandate a day in court. This bill is a bad idea for several reasons. First, for the points that I made in my previous post, the civilian criminal justice system successfully incapacitates domestic terrorists. Our laws are built to do that — it’s the international nature of al Qaeda and the necessity of military force in the expeditionary conflicts we are fighting that make things different. ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3366181 Mon, 15 Mar 2010 14:00:49 +0100 3366181 http://www.medworm.com/index.php?rid=3359212&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1uEtOjqcfck%2F In his latest attempt to probe the pharmaceutical industry, US Senator Chuck Grassley has written two big pharmacy benefit managers, as well as a trade group, asking them to provide information about their financial relationships with drugmakers. This week, he sent letters to Express Scripts, CVS Caremark and the Pharmaceutical Care Management Association (click on name to see letters). In explaining his action, Grassley - who is the ranking Republican on the Senate Finance Committee - wrote that the Medicare Payment Advisory Commission (MedPAC) recommended in a report last year that Congress should require drugmakers to report their financial relationships with pharmacy benefit managers, pharmacies, health plans, and others, but not rebates or discounts (look here). And so he asks for det... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3359212 Fri, 12 Mar 2010 15:05:05 +0100 3359212 http://www.medworm.com/index.php?rid=3350259&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FveEyZjNPb1s%2F By Jim HarperI’ve seen plenty of stories and gotten a fair number of calls from reporters about the national broadband plan. They generally want to get some insight from down in the weeds of the communications world. What do you think of this part? What do you think of that? But I’m keeping my eye on the ball: This is another industrial-policy boondoggle. It’s a government spending program, created by the so-called “Recovery Act,” that will distort the communications marketplace, and it comes at the cost to taxpayers of having their resources taken from them and handed out to the firms that are best equipped to lobby for government succor. I don’t care which community gets 1-gigabit connections. The money to pay for it should have been left with the Ame... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3350259 Tue, 09 Mar 2010 23:40:15 +0100 3350259 http://www.medworm.com/index.php?rid=3342894&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3sVDL2lxzTA%2F A confidential report issued last fall by Novartis on behalf of several drugmakers that sell ADHD meds concludes it isn’t feasible to conduct an observational, comparative long-term study to validate a signal of adverse psychiatric or cognitive outcomes from the long-term use of methylphenidate in children and adolescents with ADHD. Methylphenidate is sold as Ritalin and Concerta, for instance. The 18-page report, which recently began circulating on the Internet, was compiled in response to a requirement issued last year by the European Commission to conduct such a study after the Committee for Medicinal Products for Human Use expressed concerns about safety issues, including sudden death, cerebrovascular disorders and psychiatric disorders as well as the effects on growth (see here)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3342894 Mon, 08 Mar 2010 13:43:34 +0100 3342894 http://www.medworm.com/index.php?rid=3331276&cid=t_207803_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FPF4QysQiVgg%2F By Daniel J. MitchellFiscal crises have a predictable pattern. Step 1 occurs when the economy is prospering and tax revenues are growing faster than forecast. Step 2 is when politicians use the additional money to increase government spending. Step 3 is that politicians do not treat the extra tax revenue like a temporary windfall and budget accordingly.Instead, they adopt policies – more entitlements, more bureaucrats – that permanently expand the burden of the public sector. Step 4 occurs when the economy stumbles (in part because more resources are being diverted from the productive sector to the government) and tax revenues stagnate. If the resulting fiscal gap is large enough, as it is in places such as Greece and California, a crisis atmosphere is created. Step 5 takes pla... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3331276 Wed, 03 Mar 2010 18:53:29 +0100 3331276 http://www.medworm.com/index.php?rid=3327295&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzEJPPjqF0fE%2F After the ruckus over the FDA advisory meeting for the Provenge prostate cancer vaccine in 2007, there was little expectation that yet another panel would be convened, especially after favorable data was released last year. But Favus Institutional Research issued a report yesterday saying it spoke with some docs, who claimed to be invited to such a meeting, according to TheStreet.com. The news sent Dendreon stock down about 5 percent and set off a scramble to ascertain the truth. An FDA spokeswoman later said a panel isn’t planned, and a Dendreon spokeswoman said there was no indication from the agency a meeting was scheduled. Deutsche Bank analyst Mark Schoenebaum noted companies must be informed of a planned panel 55 business days before a PDUFA date. The Provenge PDUFA date is May... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3327295 Wed, 03 Mar 2010 13:18:25 +0100 3327295 http://www.medworm.com/index.php?rid=3302634&cid=t_207803_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk55qOTJU1vI%2F A federal judge dismissed an antitrust lawsuit filed by the Federal Trade Commission against Abbott Labs’s Solvay Pharmaceuticals unit for allegedly conspiring with several generic drug makers to delay competition for its AndroGel testosterone-replacement med (here is the ruling). The ruling is a setback for the agency, which has been pushing aggressively to end so-called pay-to-delay deals (look here). The White House, in fact, included a proposal to make these agreements illegal as part of its health care reform package (see here). The FTC alleged Solvay entered into illegal deals with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Labs to delay introduction of a generic AndroGel. The generics sought FDA approval and, in their submissions, noted their copycats wouldn’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3302634 Wed, 24 Feb 2010 12:45:00 +0100 3302634