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 'chuck'. Sat, 03 Sep 2011 02:05:30 +0100 http://www.medworm.com/index.php?rid=5181960&cid=t_307813_113_f&fid=34634&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FEmrAndHipaa%2F%7E3%2FGFmRr9VJvx8%2F Chuck Podesta is Fletcher Allen Health Care’s chief information officer. ICD-10 would not be so daunting if the deadline was not occurring during the rush to get EHRs for meaningful use. Add in value-based purchasing, bundled payments and transitioning to ACOs, and you can see why many CIOs are retiring early or migrating to the vendor or consulting world. We are just over two years away from the October 2013 deadline, and there is much work to be done. ICD-10 contains 68,000 codes, as opposed to the 13,000 currently used in the ICD-9 world. There is a code for every condition that exists on the planet. The revenue cycle system, which includes registration, HIM and billing/AR, will be the lynch pin to ICD-10 readiness. Having a solid vendor partner and a strong product is key to a succ... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=5181960 Tue, 30 Aug 2011 17:56:35 +0100 5181960 http://www.medworm.com/index.php?rid=5097089&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4FWgf9Og79Y%2F Concerned that the Office of Management and Budget is trying to gut a proposal to strengthen conflicts of interest rules for National Institutes of Health grant recipients (back story), US Senator Chuck Grassley is leaning on the OMB to cough up documents that may expose its role in the episode. In a letter sent today to OMB director Jacob Lew, Grassley asks for all records relating to communications between OMB staff and the US Department of Health & Human Services about the COI proposal, which the NIH issued in May 2010. In particular, he is targeting Cass Sunstein (see photo), who is the administrator for the OMB Office of Information and Regulatory Affairs. The OMB site does not appear to list any meetings with the OIRA or public comments issued (see this and this). “I am tr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097089 Thu, 04 Aug 2011 19:19:29 +0100 5097089 http://www.medworm.com/index.php?rid=5036310&cid=t_307813_113_f&fid=34625&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FNeilVerselsHealthcareItBlog%2F%7E3%2FwDSUut5dc7o%2F From HL7 International‘s Chuck Jaffe, M.D., at the AMDIS conference in Ojai, Calif., this morning: Related posts:Podcast: Dr. David Kibbe on personal health information, medical homes, value in healthcare and more Podcast: Dr. Bill Bria on CMIOs and medical informatics Friday funny (Source: Neil Versel's Healthcare IT Blog) Neil Versel's Healthcare IT Blog blogs http://www.medworm.com/rss/comments.php?id=5036310 Fri, 15 Jul 2011 16:26:53 +0100 5036310 http://www.medworm.com/index.php?rid=4992989&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl9r_qs2CrEo%2F Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments. In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these polici... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992989 Sat, 02 Jul 2011 14:04:29 +0100 4992989 http://www.medworm.com/index.php?rid=4960330&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeV33sONHAAI%2F Now you see recusal, now you don’t. For the past couple of years, National Institute of Mental Health director Tom Insel has found himself at the center of a furious controversy over conflicts of interest involving academic researchers who simultaneously receive NIH funding and do work for drugmakers. At one point, he was ensnared in a probe by the US Senate Finance Committee. What prompted this attention was a long-standing relationship with Charles Nemeroff, a former Emory University psychiatry department chair who accepted sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The revelation sparked a probe by the US Department of Health and Human Services Office of Inspector General. Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960330 Wed, 22 Jun 2011 13:32:59 +0100 4960330 http://www.medworm.com/index.php?rid=4960331&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIFoxZqamZN8%2F The US Senate Finance Committee is investigating Medtronic over reports that doctors with financial ties to the device maker were aware of serious problems with a widely promoted spinal fusion product, but never disclosed potential health complications in articles in medical journals. The probe is also initiated after revelations that some doctors received millions in payments, including royalties. The investigation extends long-running scrutiny of the controversial device maker and Infuse, which was approved by the FDA in 2002 and contains a genetically engineered version of a naturally occurring protein. Since then, Infuse has been implanted in more than 500,000 patients by more than 2,300 surgeons and racked up hundreds of millions of dollars in annual sales. But three years ago, concer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960331 Wed, 22 Jun 2011 11:43:21 +0100 4960331 http://www.medworm.com/index.php?rid=4813258&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FBZvbCdFqdd0%2F By Jim HarperSenator Chuck Schumer rounds out a trifecta of bloggable moments from the Senate Judiciary Subcommittee on Privacy, Technology, and the Law’s hearing this morning. Ignoring the subject of the “mobile privacy” hearing, Schumer queried the witnesses from both Google and Apple on whether they will accede to his demand that they reject certain “apps” on Android phones and iPhones. The applications Senator Schumer dislikes alert people on their mobile phones to the locations of DUI checkpoints. Senator Schumer says these apps “allow drunk drivers to evade police checkpoints,” but that statement fails to include other parties who might rightly wish to avoid police checkpoints—such as law-abiding citizens who wish to live free in this count... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4813258 Tue, 10 May 2011 19:23:55 +0100 4813258 http://www.medworm.com/index.php?rid=4560591&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBT-5WE3EYXc%2F Citing a dramatic rise in pharmaceutical thefts, five US Senate Democrats have introduced a bill to increase penalties for stealing drugs and other medical products by relying on the Racketeer Influenced and Corrupt Organization law. Better known as RICO, the proposal to use this law reflects reports of brazen robberies and organized crime involvement. In particular, the move is an attempt to crack down on a growing number of reports that stolen drugs - such as OxyContin and insulin - are diverted and relabeled, but often resold on the black market without proper storage before winding up in legitimate pharmacies or sold online. The bill would formally criminalize storing, transporting or changing labels on stolen medical products (read statements from New York’s Chuck Schumer and Oh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560591 Tue, 08 Mar 2011 22:47:33 +0100 4560591 http://www.medworm.com/index.php?rid=4501651&cid=t_307813_113_f&fid=34634&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FEmrAndHipaa%2F%7E3%2F66Ia9bwWS-8%2F In probably the biggest news of the day at HIMSS, we got the following tweet spreading quickly through the Twittersphere: #bbpBox_39359393585700864{background:#9AE4E8 url(http://a3.twimg.com/a/1297983335/images/themes/theme1/bg.png) no-repeat !important;padding:20px;}#bbpBox_39359393585700864 p.bbpTweet{background:#fff;padding:10px 12px 10px 12px !important;margin:0 !important;min-height:48px;color:#333333 !important;font-size:18px !important;line-height:22px;-moz-border-radius:5px;-webkit-border-radius:5px}#bbpBox_39359393585700864 p.bbpTweet a {color:#0084B4 !important}#bbpBox_39359393585700864 p.bbpTweet span.metadata{display:block;width:100%;clear:both;margin-top:8px !important;padding-top:12px !important;height:40px;border-top:1px solid #e6e6e6}#bbpBox_39359393585700864 p.bbpTweet sp... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=4501651 Mon, 21 Feb 2011 03:29:06 +0100 4501651 http://www.medworm.com/index.php?rid=4495432&cid=t_307813_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=4450522&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE_7jnYJDPXs%2F Nearly a year ago, the FDA wrote US Senator Chuck Grassley that criteria had been developed to determine which cases should be selected for prosecuting individual executives (read the letter). The move came after growing criticism that drugmakers paid huge fines to settle allegations of fraud, but higher ups were never held responsible and the payouts were seen as a cost of doing business. Since then, FDA deputy chief for litigation Eric Blumberg gave a speech reiterating agency interest in targeting pharma execs (back story). These moves also come as the Health and Human Services Office of Inspector General pushes for measures to make it possible to ban pharma execs from doing business with federal health programs, if their companies have been convicted of fraud. The FDA plan, though, ha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450522 Tue, 08 Feb 2011 13:08:54 +0100 4450522 http://www.medworm.com/index.php?rid=4411723&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCJkmCAQ7CCQ%2F Earlier this week, the US Department of Health & Human Services trumpted its track record in recovering $4 billion from investigations of healthcare fraud, some of which was made possible thanks to qui tam, or whistleblower lawsuits alleging violations of the False Claims Act (you can read the report here). Many drugmakers were targets and paid big fines, (back story) and the implication offered was that more such settlements are in the offing. But how many investigations are actually under way? The answer came just a couple of days later courtesy of US Senator Chuck Grassley, who referenced some data the HHS provided him in a Jan. 24 letter that was written in response to a request he made last month for a breakdown of the fraud probes. And so we now learn that, as of Jan. 4, there w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4411723 Fri, 28 Jan 2011 13:20:11 +0100 4411723 http://www.medworm.com/index.php?rid=4399818&cid=t_307813_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=4399826&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTU6O6Hd_s60%2F Another day, another letter to the FDA commish from a group of bipartisan US senators over the biologics debate. The latest missive comes from health committee chair Tom Harkin, John McCain, Chuck Schumer and Sherrod Brown, who are “extremely concerned about possible misinterpretations” of the biosimilars statute “that could further delay the availability of generic biologic drugs.” They are referring to a provision in the healthcare reform law that says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a different group of senators - Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. At issue... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399826 Tue, 25 Jan 2011 16:57:23 +0100 4399826 http://www.medworm.com/index.php?rid=4394744&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-b4oJVcZs1A%2F Over the past few years, the feds have successfully forced numerous drugmakers to settle charges that they deliberately misreported pricing info in order to hike reimbursements from Medicare and Medicaid. And behind this string of settlements is a pharmacy called Ven-A-Care of the Florida Keys, which created a whistleblowing cottage industry of its own by simply rummaging through data. For instance, a 2005 California suit alleged that a one-gram vial of the antibiotic vancomycin was sold to healthcare providers for $6.29, but billed to Medi-Cal for $58.37, while 50 milligram tablets of the atenolol blood pressure med were billed to pharmacies at $3.04 and to Medi-Cal at $70.30. Armed with such discrepances, Ven-A-Care filed lawsuit after lawsuit - and reaped big rewards. Since 2000, the li... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394744 Tue, 25 Jan 2011 14:21:49 +0100 4394744 http://www.medworm.com/index.php?rid=4343331&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMzN0NGIvnh4%2F In 2008, the US Senate Finance Committee charged that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, the former chair of its psychiatry department, who owned a substantive amount of stock in Corcept Therapeutics, which was studying the development of mifepristone, or RU-486, for treating psychiatric depression. Beyond his stock holdings, Schatzberg was also listed as a co-patent holder for the drug, which is best known for inducing abortion, and he received a grant from the National Institutes of Health to oversee the research. The allegation was part of a lengthy probe into the wider issue of taxpayer-funded research and undisclosed and unmonitored conflicts involving universities, academic researchers and the pharmaceutical industr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343331 Thu, 13 Jan 2011 14:26:00 +0100 4343331 http://www.medworm.com/index.php?rid=4233418&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fvx8qf4-K0xE%2F The US Government Accountability Office has denied any failures in its January 2010 report about the FDA’s Office of Criminal Investigation. The finding was made in response to a demand by Senator Chuck Grassley that the GAO conduct an internal probe after being told by a whistleblower the GAO report was compromised by a mole who tipped off OCI officials and the GAO failed to detect allegedly disturbing activities by the outgoing OCI director, Terry Vermillion, who is now about to retire (back story). Grassley was told Vermillion allegedly: relocated his domicile to Hampton, Va., and directed OCI work mostly over the phone; used OCI tech support and IT staff to do personal work for him; authorized payment for government contracting training at George Washington University for a fello... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233418 Mon, 06 Dec 2010 19:14:30 +0100 4233418 http://www.medworm.com/index.php?rid=4214482&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Faox1fgZ5g7o%2F Stung by revelations that a mole may have compromised a report issued earlier this year about the FDA’s Office of Criminal Investigation, the US Government Accountability Office is now conducting an internal probe into the leaks, which recently prompted US Senator Chuck Grassley to chastise the agency and demand an investigation. The move, according to a congressional source familiar with the situation, comes just one week after Terry Vermillion announced he would retire next month as head of the FDA’s OCI (look here). The GAO report (look here) found the FDA’s OCI suffers from lax oversight, despite increased in funding and staffing over the past decade, although several of the complaints were leveled specifically at Vermillion, who is a retired Secret Service agent. We awai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4214482 Tue, 30 Nov 2010 15:27:36 +0100 4214482 http://www.medworm.com/index.php?rid=4197063&cid=t_307813_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-doctors-should-be-less-like-chuck-yeager-and-more-like-captain-sullenberger%2F2010.11.24 A recent medical error of a wrong-site surgery that occurred in one of the country’s best hospitals, Massachusetts General, reminded me why doctors need to be less like Chuck Yeager and more like Captain Sullenberger. Growing up, I always wanted to be a fighter pilot, years before the movie “Top Gun” became a part of the American lexicon. My hero was World War II pilot Chuck Yeager, who later became one of the country’s premier test pilots flying experimental jet and rocket propelled planes in a time when they were dangerous, unpredictable, and unreliable. Much like the astronauts in the movie “The Right Stuff,” Yeager and his colleagues literally flew by the seat of their pants, made it up as they went along, and never really knew if their maiden flight... Better Health blogs http://www.medworm.com/rss/comments.php?id=4197063 Wed, 24 Nov 2010 17:00:00 +0100 4197063 http://www.medworm.com/index.php?rid=4197363&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-g6Xl-GN_ZM%2F Perhaps this is a coincidence. But after months of sour news about the performance of his FDA unit, Terry Vermillion yesterday announced to FDA staff that he is retiring next month as the head of the agency’s Office of Criminal Investigation. An FDA spokesman acknowledged the retirement, but declined to comment. The move comes after the US General Accountability Office issued a report earlier this year that found the FDA’s Office of Criminal Investigation suffers from lax oversight, despite increased in funding and staffing over the past decade (here is the report). That followed criticism two years ago by House Republicans who expressed concern the OCI was overly emphasizing drug-abuse cases instead of pursuing researchers and drugmakers that commit crimes when seeking approval fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197363 Tue, 23 Nov 2010 17:18:28 +0100 4197363 http://www.medworm.com/index.php?rid=4179519&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuFNz5Akkn8M%2F Earlier this year, US Senator Chuck Grassley asked all 50 states to provide data on doctors who wrote huge numbers of prescriptions for specific drugs that are paid for by Medicaid programs. The move was prompted by reports indicating certain meds - notably, several widely used antipsychotics, as well as the OxyContin painkiller and Xanax anxiety pill - have been prescribed at particularly high rates. The purpose in launching this inquiry was to determine whether the drugs are overprescribed and, consequently, costing taxpayers unnecessarily. And so Grassley, who is the ranking Republican on the committee and has launched several probes into the pharmaceutical industry, recently followed up with the Department of Health and Human Services in hopes of learning how the agency oversees paymen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179519 Thu, 18 Nov 2010 22:19:22 +0100 4179519 http://www.medworm.com/index.php?rid=4106062&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPTSfGsg6psw%2F In his latest effort to probe conflicts of interest in the drug and device industry, US Senator Chuck Grassley has written FDA commish Margaret Hamburg to ask how the agency determines whether the financial interests of clinical investigators may adversely affect patients in clinical trials and the “integrity and reliability” of the studies submitted for product approval. As Grassley notes in his October 22 letter, the FDA requires manufacturers that submit applications and clinical studies for product approvals to file disclosure statements about the financial interests of investigators who are not full-time or part-time employees, but are or were involved in conducting studies submitted to the FDA. Specifically, disclosures should include info about financial arrangements bet... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106062 Mon, 25 Oct 2010 13:03:45 +0100 4106062 http://www.medworm.com/index.php?rid=4098458&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWhw08OSezIA%2F In the latest chapter in the Stephen Ondra saga, US Senator Chuck Grassley has written both the US Department of Veterans Affairs and Medtronic in search of still more information about the prominent spinal surgeon and his dealings with device maker both before and after he accepted his current government position as the VA’s senior policy advisor for health affairs. The backdrop is an inquiry begun late last month, when Grassley - the ranking Republican the Senate Finance Committee who has undertaken numerous conflict-of-interest probes into drug and device makers - noted that Ondra was paid about $4 million in royalties by Medtronic in the two years before joining the VA in 2009. And the senator cited emails in which Medtronic officials are attempting to secure a position for Ondra... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098458 Fri, 22 Oct 2010 19:30:26 +0100 4098458 http://www.medworm.com/index.php?rid=4074447&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZIxbuK-7Dec%2F Last March, the US General Accountability Office issued a report that found the FDA’s Office of Criminal Investigation suffers from lax oversight, despite increased in funding and staffing over the past decade. And the GAO also concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The effort was undertaken in response to a request by US Senator Chuck Grassley, who has now written a follow-up Sept. 16 letter to Gene Dodaro, the GAO’s acting comptroller general, over concerns that the findings in the GAO report “were less than stellar” after hearing from an unnamed whistleblower who charged the agency report was compromised by a mole. “I am not... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074447 Thu, 14 Oct 2010 15:27:28 +0100 4074447 http://www.medworm.com/index.php?rid=4061077&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpsGHxoA_0cE%2F File this under a touch of irony. Early last year, Stephen Ondra headed spine surgery at Northwestern Memorial Hospital in Chicago, and was successfully touted by Medtronic for a position in the Obama administration. Among his attributes: consulting for the device maker, previous efforts on behalf of the Obama team and his work on physician-industry relationships and transparency, according to various emails between Medtronic execs (look here). Within a few days, however, Ondra objected to the proposed nomination of another spine surgeon, Charles Rosen, as US Surgeon General. Why? As founder of the Association of Medical Ethics, Rosen publicly questioned consulting ties between doctors and device makers and, for his trouble, allegedly suffered retaliation by members of the American Academy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4061077 Tue, 12 Oct 2010 12:23:05 +0100 4061077 http://www.medworm.com/index.php?rid=4027212&cid=t_307813_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F10%2F03%2F8-ways-to-manage-anxiety-on-an-anniversary%2F Most of us circle a few days of the calendar year that we know will be difficult to get through: the anniversary of a death, traumatic event, or even happy occasion. These dates are charged with emotion. Sometimes we feel trapped by these dates — like there’s nothing we can do to stop them. The approaching date creates a sense of panic and anxiety in many of us, and we can feel out of control. The one benefit from anniversary anxiety is that we can predict it and therefore prepare for it. Here are 8 ways to do just that. 1. Forecast your emotions. You’ve circled the day. You know it’s coming. Now get honest with yourself about how you might feel on that day. If it’s the anniversary of a death of a loved one, get ready to celebrate that person’s life wit... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4027212 Sun, 03 Oct 2010 13:30:09 +0100 4027212 http://www.medworm.com/index.php?rid=3987234&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaWze7AH3p9A%2F For the past three years, Paul Thacker was an investigator on the US Senate Finance Committee, working for Iowa Republican Chuck Grassley, who is the ranking minority member. During his tenure, Thacker was central to probes into the pharmaceutical industry, specifically, investigations into the disclosure of clinical trial data for GlaxoSmithKline’s Avandia diabetes pill and undisclosed financial conflicts of interest among academic researchers. Earlier this month, the former US Army specialist left to join a non-profit watchdog, the Project on Government Oversight. We caught him as we walked out the door to ask about his efforts and whether he thought the probes created any change. Pharmalot: Why leave now? Thacker: I’ve been on the committee for three years and two years is cons... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987234 Mon, 20 Sep 2010 13:37:49 +0100 3987234 http://www.medworm.com/index.php?rid=3973115&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC6JmIOJ13uA%2F Earlier this year, the US Senate Finance Committee wrote to the US Department of Health and Human Services to complain that the agency wasn’t properly investigating complaints about pharmacies that are, essentially, fly-by-night operations and are billing millions of dollars to Medicare and private insurers - and then disappearing. Examples included: A Miami area pharmacy billed an insurer $26,000 for antipsychotics and inhalers during a three-day period, but the owners soon disappeared and the store was abandoned. A Los Angeles pharmacy billed $1.3 million under the Part D program over 18 months, more than double the Rite Aid pharmacy blocks away. Another Miami pharmacy billed an insurer $245,000 in false claims in less than three months, and the owner later bought a one-way ticket ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973115 Wed, 15 Sep 2010 11:58:55 +0100 3973115 http://www.medworm.com/index.php?rid=3954228&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F_xVwx6kegIc%2F By Mark A. CalabriaLike President Bush before him, Obama has a knack for taking the worst ideas of his opponents and making them his own.  It is truly bipartisanship in the worst of ways (think Sarbanes-Oxley, the TARP or No Child Left Behind).  The newest example is the President’s proposed “infrastructure bank.”  A bill along those lines was introduced a few years ago by then Senator Hagel, although the idea is far from new. First, let’s get out of the way the myth that we have been “under-funding” intrastructure.  Take the largest, and usually most popular, piece:  transportation.  Over the last decade, transportation spending at all levels of government has increased over 70 percent.  One can debate if that money has been spent wisely, but the... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3954228 Thu, 09 Sep 2010 16:03:26 +0100 3954228 http://www.medworm.com/index.php?rid=3943025&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FciVEK-I929s%2F Last December, the Senate Finance Committee’s Chuck Grassley sent letters 33 medical advocay groups, including the American Medical Association, the American Cancer Society, the American Heart Association and American Academy of Family Physicians for details about the money they and their board members received from drug and device makers (background here). The move came several months after Grassley and his staffers discovered that the National Alliance on Mental Illness received sizeable pharma donations while also conducting lobbying efforts with drug makers and pushing legislation that benefits these companies. Since then, NAMI has posted that sort of info on its web site (look here). But what about the others? Well, The Chronicle of Philanthropy has done an update by checking in wit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943025 Tue, 07 Sep 2010 15:14:41 +0100 3943025 http://www.medworm.com/index.php?rid=3938317&cid=t_307813_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fchuck-klosterman-on-power%2F Every relationship is fundamentally a power struggle, and the individual in power is whoever likes the other person less. – Chuck Klosterman Post from: BlissTree Chuck Klosterman on Power (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3938317 Mon, 06 Sep 2010 13:00:03 +0100 3938317 http://www.medworm.com/index.php?rid=3929454&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQuR3pp4IJdg%2F Did the American Heart Association’s Circulation journal publish a ghostwritten article about Avandia? There has been disagreement about this ever since the US Senate Finance Committee released a report in July about the controversy concerning the GlaxoSmithKline diabetes pill. Glaxo, you may recall, once ran a program aptly named Cassper, or Case Study Publications for Peer Review, which was designed to assist researchers with their articles. At the time, the committee sent a wad of documents to the FDA that contained emails and drafts of different manuscripts. One appeared slated for the American Journal of Cardiology and the lead author was Baylor College’s Steve Haffner (see this). Also included was a draft manuscript of a study destined for Circulation (see attachments H a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3929454 Thu, 02 Sep 2010 19:55:48 +0100 3929454 http://www.medworm.com/index.php?rid=3915286&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP96r1KXl_cQ%2F Just how useful are non-inferiority trials? For the uninitiated, such trials compare a drug being developed with one that is already approved by the FDA. Drugmakers, of course, pursue such studies so they can show their new med is no worse than another, and may even show some benefits. But this approach has generated criticism - why approve a new drug when an existing med does the job? There is also concern about ‘biocreep.’ This refers to concerns that successive generations of drugs that are approved based on non-inferiority trials can lead to less effective drugs over time, including those that are, ultimately, no more effective than a placebo. And so after a request from several members of Congress, the General Accountability Office has issued a new report that indicates th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915286 Mon, 30 Aug 2010 13:28:47 +0100 3915286 http://www.medworm.com/index.php?rid=3858141&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FTqwbOHfkRQ0%2F By Daniel GriswoldA $600-million bill to enhance border enforcement has hit a temporary snag in the Senate, but it is almost inevitable, with an election only a few months away, that Congress and the president will spend yet more money trying to enforce our unworkable immigration laws. “Getting control of the border” is the buzz phrase of the day for politicians in both parties, from Sen. John McCain, R-Ariz., to Sen. Chuck Schumer, D-N.Y. Never mind that apprehensions are down sharply along our Southwest border with Mexico, mostly I suspect because of the lack of robust job creation in the unstimulated Obama economy. Meanwhile, since the early 1990s, spending on border enforcement has increased more than 700 percent, and the number of agents along the border has increased five-fold, f... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3858141 Wed, 11 Aug 2010 15:36:28 +0100 3858141 http://www.medworm.com/index.php?rid=3854747&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fda1v_H59wrU%2F Pharma lobbyists on Capitol Hill and academics at major universities may be rejoicing tonight at the news that Paul Thacker, an investigator for US Senator Chuck Grassley, is leaving to join the Project on Government Oversight, a non-profit watchdog, next month. No formal announcement was made, but his departure was disclosed in an email he distributed. During his three-year tenure, the former US Army specialist played a central role in the numerous investigations that examined prescription-drug safety and the undisclosed financial conflicts of interest involving academic researchers who simultaneously receive federal grants while doing work for drugmakers. In the process, Thacker and his colleagues prompted the National Institutes of Health and various universities to begin altering their... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3854747 Tue, 10 Aug 2010 21:56:49 +0100 3854747 http://www.medworm.com/index.php?rid=3854509&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FBKQ4zn0A4j8%2F By Daniel Ikenson This capsizing container ship in the Port of Mumbai strikes me as the perfect metaphor for U.S. trade policy, with Skipper Pelosi at the helm.   Just imagine how many jobs we can create by sending imports to the bottom of the sea.  Heck, think of all the jobs we could create by sinking our own exports and making them all over again. Senator Schumer, I’m just kidding. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3854509 Tue, 10 Aug 2010 17:57:59 +0100 3854509 http://www.medworm.com/index.php?rid=3823160&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtzsBy8SMXoI%2F Early last year, a stink arose at Tufts University when top university officials refused to allow other administrators to be panelists at a conference on conflicts of interest in medicine and research because Paul Thacker, an aide to US Senator Chuck Grassley, was due to give the keynote speech. Why? They were uncomfortable that Grassley was investigating ties between a Tufts professor and drugmakers (back story here and here). In the same time period, however, one subject of the ongoing Grassley probe did speak at Tufts. According to disclosure forms filed with his employer, Charles Nemeroff, who is now psychiatry chair at the University of Miami Miller School of Medicine, gave a lecture at Tufts sometime between June 1, 2009 and May 31, 2010. He was paid between $1,000 and $5,500, but th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3823160 Wed, 04 Aug 2010 14:09:54 +0100 3823160 http://www.medworm.com/index.php?rid=3806023&cid=t_307813_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=3784244&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F1UPfeJEsVqQ%2F By Daniel IkensonVia General Motors, American taxpayers will soon own a 61 percent stake in a Texas-based company called AmeriCredit.  GM announced plans yesterday to acquire the auto finance firm for $3.5 billion, which management believes will help boost its auto sales and improve chances for an IPO later this year or next.  Thus, a greater chance for re-privatization later is the rationalization for more nationalization now. For those who opposed the nationalization of GM for its affront to free markets and the rule of law in the first place, the acquisition presents a dilemma.  On one hand, the deal means that the nationalization virus is spreading to infect another company in a different industry, ensuring that yet more business decisions are driven by political, rather than econo... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3784244 Fri, 23 Jul 2010 15:57:26 +0100 3784244 http://www.medworm.com/index.php?rid=3737293&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcDZXteAWacE%2F For the past several weeks, National Institute of Mental Health director Tom Insel has found himself at the center of a furious controversy over conflicts of interest involving academic researchers who simultaneously receive NIH funding and do work for drugmakers. An ongoing probe, meanwhile, by the Senate Finance Committee has made a poster boy of Charles Nemeroff, an old Insel colleague who recently landed a job as the psychiatry chair at the University of Miami med school. Insel was caught up in this affair, because he spoke with the med school dean Pascal Goldschmidt, who asked for a reference before hiring Nemeroff, who was working at Emory University when the Senate committee learned of the large consulting fees he received from GlaxoSmithKline. The query from Goldschmidt was made ju... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3737293 Thu, 08 Jul 2010 14:14:41 +0100 3737293 http://www.medworm.com/index.php?rid=3718695&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3710795&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYYomDF92Fdo%2F For those tracking the ongoing investigation by the Senate Finance Committee investigation into conflicts of interest among academic researchers and industry funding, Charles Nemeroff was one of the targets. The former Emory University professor, who now works at the University of Miami, came to the committee’s attention because he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The Senate investigation, spearheaded by Chuck Grassley, the Iowa Republican, prompted Emory to suspend Nemeroff’s work on an NIH grant and asked him to step down as chair of psychiatry while it studied his conduct. And the Department of Health and Human Services Office of Inspector General began ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710795 Tue, 29 Jun 2010 14:00:58 +0100 3710795 http://www.medworm.com/index.php?rid=3706998&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfJG8TguUd3s%2F As the National Institutes of Health readies new conflict of interest rules governing interactions between academic researchers and drugmakers, US Senator Chuck Grassley has released a report he believes should convince the agency to incorpoate a tougher stance toward ghostwriting in its forthcoming policy. At issue is the notion that ghostwritten articles unfairly influence physicians and their approach to practicing medicine. “The NIH ought to ensure that the final rule defines the term ’significant financial interest’ to include pharmaceutical and device company financing and/or other material contribution or support to develop medical literature, including but not limited to conceiving and designing the underlying paper, collecting and/or analyzing the data, and draft... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706998 Mon, 28 Jun 2010 11:53:14 +0100 3706998 http://www.medworm.com/index.php?rid=3695808&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFoSny4-5AJQ%2F The debate over industry funding of continuing medical education took a tense turn earlier this month when the American Heart Association promised to aggressively appeal a rule that would prevent doctors from receiving needed credit for attending medical meetings where industry people talk about their drugs (see background). Specifically, AHA president Clyde Yancy was incensed that the Accreditation Council for Continuing Medical Education told him his organization shouldn’t have industry speakers at any scientific sessions at its upcoming annual meeting. The ACCME policy was set in 2004 and updated last year, but his vow to appeal undescored opposing views over industry influence on post-graduate medical education and whether it has gotten out of hand. The issue, in fact, will be de... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3695808 Thu, 24 Jun 2010 19:11:38 +0100 3695808 http://www.medworm.com/index.php?rid=3659184&cid=t_307813_180_f&fid=38612&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fpickthebrain%2FLYVv%2F%7E3%2FuWWOGx0Qcsw%2F There’s always something we can learn from people that have been able to do things that we still only dream about. When I was younger I used to watch Texas Rangers on TV, and I laughed a lot. Chuck Norris from Texas Rangers is obviously admired by a whole lot of other people as well, because the amount of Chuck Norris jokes online is huge. That’s understandable, because the character really was funny. As I was skimming through the jokes, I thought that there might be a few lessons to be learned from the way Chuck Norris lives his life, although he might not be the perfect role model for self-improvement enthusiasts. Here are five things that we could in my opinion learn from Chuck Norris: 1. “Chuck Norris doesn’t read books. He stares them down until he gets the information he wan... PickTheBrain | Motivation and Self Improvement blogs http://www.medworm.com/rss/comments.php?id=3659184 Mon, 14 Jun 2010 05:17:56 +0100 3659184 http://www.medworm.com/index.php?rid=3641321&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrYivhU7sae4%2F The Charles Nemeroff affair encompasses more people all the time. Now, the University of Miami Medical School has become ensnared in the ongoing probe launched by US Senator Chuck Grassley, who investigated Nemeroff as part of an inquiry into undisclosed financial conflicts of intereest among academic researchers who receive federal grants. You may recall Nemeroff, who was recently hired by the University of Miami, had departed Emory University after the Senate probe disclosed he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (see this). Before his departure, Emory imposed a two-year ban on grants for on Nemeroff. This week, however, the U of Miami med school head, Pascal Gol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3641321 Tue, 08 Jun 2010 15:44:41 +0100 3641321 http://www.medworm.com/index.php?rid=3595565&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FjmFcqKouMGA%2F By Jim HarperAmid the hullaballoo about Facebook and privacy, it’s easy to forget the most powerful privacy setting. In my 2004 Policy Analysis, “Understanding Privacy—and the Real Threats to It,” I wrote about the “privacy-protecting decisions that millions of consumers make in billions of daily actions, inactions, transactions, and refusals.” Inactions and refusals. Declining to engage in activities that emit personal information protects privacy. Not broadcasting oneself on Facebook protects privacy. Not going online protects privacy. The horror, some may think, of not having access to the wonders of the online world. Actually, many people live full and complete lives without it, enjoying the perfect online privacy default. The irony is a little too r... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3595565 Tue, 25 May 2010 14:46:14 +0100 3595565 http://www.medworm.com/index.php?rid=3585835&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Focplmedia.od.nih.gov%2Fnihradio%2FNIHtelebrifing-2010.05.20.mp3 In a bid to restore public trust, the National Institues of Health has proposed new rules that would require academic researchers who receive agency funding to more thoroughly report any financial conflicts of interest, and also require institutions - such as universities - to do a better job of gathering this information and then forwarding it to the NIH. This includes posting info on a web site. The move follows an ongoing probe by the US Senator Chuck Grassley of the Senate Finance Committee, who uncovered several examples in which academic researchers accepted funding from both the NIH and various drugmakers, but failed to fully or properly disclose the extent of their financial ties. At the same time, several universities failed to monitor their faculty for conflicts. At the heart of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3585835 Thu, 20 May 2010 17:05:55 +0100 3585835 http://www.medworm.com/index.php?rid=3542571&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FuhzDuJBH_9Y%2F By David BoazSarah Palin has endorsed Carly Fiorina for U.S. Senate in California, showing commendable charity toward a woman who gave her one of her many Bad Headline Days in September 2008 by telling an interviewer that Palin wouldn’t be qualified to run a major company. (Fiorina did add, “But you know what? That’s not what she’s running for.”) Palin is way off base, though, when she writes: I support Carly as she fights through a tough primary against a liberal member of the GOP who seems to bear almost no difference to Boxer, one of the most leftwing members of the Senate. Ignoring conservative Chuck DeVore, who probably has the support of a lot of Palin fans, Palin is taking aim at frontrunning former congressman Tom Campbell. But if her aim was that far ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3542571 Fri, 07 May 2010 15:42:41 +0100 3542571 http://www.medworm.com/index.php?rid=3530028&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk9HNoSpWCpM%2F Three years ago, a federal law was enacted that provided incentives to states to pass their own versions of the False Claims Act, which allows people who are not affiliated with the government to file lawsuits against federal contractors claiming fraud against the government. There have been a spate of these whistleblower, or qui tam, lawsuits in the pharma world lately (see here, here and here). The Department of Health and Human Services and the Department of Justice were chartered with overseeing whether the states are meeting the qualifications that would allow them to receive a share of any proceeds recovered. And so last week, Senator Chuck Grassley, the ranking Republican on the Senate Finance Committee, who regularly probes drugmakers, wrote the agencies because only 14 states are... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3530028 Tue, 04 May 2010 15:44:30 +0100 3530028 http://www.medworm.com/index.php?rid=3515635&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjIXtyqL7RSU%2F Yesterday, the House Agriculture FDA Appropriations Subcommittee held a hearing on drug safety with a special emphasis on Avandia, the GlaxoSmithKline diabetes pill that has been linked to heart problems amid controversy over the extent to which the drugmaker disclosed the risks. The hearing comes two months after the Senate Finance Committee released a report detailing internal disagreement within the FDA and new revelations about Glaxo deliberations. Meanwhile, the FDA plans an advisory committee meeting in July, but may halt a 16,000-patient safety study called TIDE over ethics concerns (background). Here’s what a few of those speaking had to say…. Rosa DeLauro, subscommittee chair: When this drug was approved in 1999, the FDA requested the Glaxo conduct a post-market study,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515635 Thu, 29 Apr 2010 12:52:32 +0100 3515635 http://www.medworm.com/index.php?rid=3515639&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyPZffgAk_4I%2F The latest chapter in the saga involving the National Alliance on Mental Illness, or NAMI, and the amount of money accepted from the pharmaceutical industry has millions being contributed to NAMI state chapters. And Chuck Grassley, the ranking Republican on the Senate Finance Committee, who has been probing the relationship between patient groups and drugmakers and how this may influence the practice of medicine, wants to know what the national organization is doing to make the state chapters more transparent, and how the money is used. You may recall that a majority of donations made to NAMI, a big advocacy group, have come from drugmakers in recent years. And the disclosure comes after protracted criticism of NAMI for coordinating lobbying efforts with drug makers and pushing legislatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515639 Wed, 28 Apr 2010 18:59:52 +0100 3515639 http://www.medworm.com/index.php?rid=3505134&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJYBY4SIvTJ4%2F Last December, the Health and Human Services Office of Inspector General released a report showing that the Centers for Disease Control and Prevention was having a hard time gathering sufficient financial disclosure info from so-called Special Government Employees, or SGEs, who serve on CDC advisory committees. The HHS OIG reviewed info provided to 17 committees that met in 2007 and also found that many SGEs served on committees, even though potential conflicts weren’t disclosed. And so Chuck Grassley, the ranking Republican on the Senate Finance Committee who has spent the last few years probing conflicts of interest among government agencies, academic researchers and the pharmaceutical industry, has written a letter to the CDC noting that 41 percent of SGEs didn’t receive eth... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3505134 Mon, 26 Apr 2010 16:20:12 +0100 3505134 http://www.medworm.com/index.php?rid=3479834&cid=t_307813_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2F6Qhao8aVVnM%2F Cover for "Mom, Have You Seen My Leather Pants? by Craig A. Williams Patrick Sauer is funny. This is his third “Read It Like a Man” weekly column for Blisstree. Click to read his original intro, and first and second installments. Chapter 3: 80s Hair Metal I have this pet theory that the essence of what these here United States are all about can be summed by Van Halen. (Here me out – you’ll kill at the next happy hour.) We talk a big game about freedom, liberty, and democracy, but the most honest quote about our country came from one of its worst presidents, Mr. Calvin Coolidge, when he noted that “the business of America is business.” It took us almost a century to go to war over the idea that black people maybe weren’t property, and that was long after... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=3479834 Fri, 16 Apr 2010 17:53:54 +0100 3479834 http://www.medworm.com/index.php?rid=3420757&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNU_v5klsnPs%2F Lo, and the Lord sayeth to the Spinmeister: ‘Let My Pharmalot Go!’ But the Spinmeister was a cunning strategist and spoke out of both sides of his mouth. And still he enslaved poor Pharmalot. And so the Lord visited excruciating plagues upon the Spinmeister: Steve Nissen; Henry Waxman; Margaret Hamburg; Harlan Krumholz; Chuck Grassley; Catherine D’Angelis; Michael Loucks; Sid Wolfe; Jon Leibowitz and Jamie Love. Yet, the Spinmeister would not relent, and so the Lord slayed the compensation prince in each House of Pills. And finally, the Spinmeister released poor Pharmalot, who took his magic laptop and then wandered the Short Hills of the Garden State in search of the Promised Truth. But lo, the Spinmeister sent his army of flaks after poor Pharmalot. A mighty babble was heard a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420757 Mon, 29 Mar 2010 20:32:03 +0100 3420757 http://www.medworm.com/index.php?rid=3382797&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Ffoj0uy-ak_M%2F By Jim HarperThere is much to commend in the op-ed on immigration reform that Senators Chuck Schumer (D-NY) and Lindsey Graham (R-SC) published in this morning’s Washington Post. Unfortunately, they lead with their worst idea: a biometric national ID card, mandatory for all American workers. Here’s the good: “Americans overwhelmingly oppose illegal immigration and support legal immigration,” they say. “Throughout our history, immigrants have contributed to making this country more vibrant and economically dynamic.” Their plan includes problem-solving proposals: “creating a process for admitting temporary workers” and “implementing a tough but fair path to legalization.” The latter would reduce the population of illegal aliens in ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3382797 Fri, 19 Mar 2010 13:45:30 +0100 3382797 http://www.medworm.com/index.php?rid=3370668&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAq2HsV7EZNE%2F In response to the ongoing controversy over financial conflicts of interest university and med schools researchers funded by the National Institutes of Health, the Project On Government Oversight is urging NIH director Francis Collins to disclose financial arrangements of its researchers in a public database. The issue is also being pursued by US Senator Chuck Grassley, who is probing researchers who accept funding from the NIH and pharma, as well as instances where their universities have failed to monitor or report payments. According to current NIH regulations, payments above $10,000 should be reported (see background here). In a March 11 letter, POGO noted that financial arrangements are currently reported confidentially to a researcher’s institution, but “the confidential... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3370668 Tue, 16 Mar 2010 17:20:53 +0100 3370668 http://www.medworm.com/index.php?rid=3366292&cid=t_307813_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fonc-i-trust It's my nature to question authority. Whether it's religion, politics, or even my local administrative leadership, authority figures must earn my trust. Earning that trust is not easy. As folks who work closest with me know, I believe that much of Dilbert is based on true case studies. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3366292 Mon, 15 Mar 2010 12:36:52 +0100 3366292 http://www.medworm.com/index.php?rid=3354299&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F6TxM0YyU3qg%2F By Jim HarperCompromise is catnip in Washington, D.C. That’s my best guess at why Senator Lindsey Graham (R-SC) would endorse New York Senator Chuck Schumer’s (D) widely reviled plan to create a mandatory biometric national ID system. Schumer’s national ID plans have no more definition today than when he wrote about them in his 2007 campaign manifesto Postitively American. Among the thin gruel of that book is a two-page lump displaying more ignorance than understanding of how identity systems work and fail. Schumer doesn’t know the difference between an identifier—a characteristic used to distinguish or group people—and an identification card or system, which does the entire task of proving a person’s previously fixed identity. (My thin gruel ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3354299 Thu, 11 Mar 2010 17:03:00 +0100 3354299 http://www.medworm.com/index.php?rid=3346442&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fch32bVW5xiI%2F By Jim HarperSo reports the Wall Street Journal: Lawmakers working to craft a new comprehensive immigration bill have settled on a way to prevent employers from hiring illegal immigrants: a national biometric identification card all American workers would eventually be required to obtain. It’s the natural evolution of the policy called “internal enforcement” of immigration law, as I wrote in my paper, “Franz Kafka’s Solution to Illegal Immigration.” Once in place, watch for this national ID to regulate access to financial services, housing, medical care and prescriptions—and, of course, serve as an internal passport. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3346442 Tue, 09 Mar 2010 14:35:24 +0100 3346442 http://www.medworm.com/index.php?rid=3290991&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzmPNNoYg-CQ%2F Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports, The New York Times writes. Moreover, if every diabetic taking Avandia were given Actos instead, about 500 heart attacks and 300 cases of heart failure would be avoided each month. The pill was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be yanked (Graham said this in 2007 - look). Some FDA officials want Avandia withdrawn because they believe a safer alternative exists, the Times adds, noting others insist studies offer contradictory info and Avandia should remain an option. GlaxoSmithKline, which makes the pill, says it studied Avandia extensively and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3290991 Sat, 20 Feb 2010 15:29:18 +0100 3290991 http://www.medworm.com/index.php?rid=3290992&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FncX1t4U0Bgc%2F Grassley, who is the ranking Republican on the US Senate Finance Committee, is investigating the relationship between WebMD and drugmakers after learning the web site is running a TV ad that encourage people to take a depression-screening test sponsored by Eli Lilly, which sells Cymbalta. So he wants WebMD, which lots of folks visit for medical info, to disclose its ties to the industry, in general, because the Lilly sponsorship raises questions about WebMD’s “independence,” according to this Feb. 18 letter to WebMD exec Wayne Gattinella. The ad encourages people to visit WebMD’s site to take a depression-screening test (see here). The test asks questions about suffering emotional or physical symptoms associated with depression and includes banner ads on the top and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3290992 Fri, 19 Feb 2010 23:40:41 +0100 3290992 http://www.medworm.com/index.php?rid=3269682&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FLD7c7mX6C8Y%2F By John SamplesSnowstorm notwithstanding, Sen. Charles Schumer and Rep. Chris Van Hollen introduced legislation in response to the Citizens United decision. A summary of their effort can be found here. Some parts of the proposal are simply pandering to anti-foreign bias (corporations with shareholding by foreigners are prohibited from funding speech) and anger about bailouts (firms receiving TARP money are banned from funding speech). Government contractors are also prohibited from independent spending to support speech. We shall see whether these prohibitions hold up in court. The censorship of government contractors and TARP recipients will likely prove to be an unconstitutional condition upon receiving government benefits. Despite Citizens United, Congress will try to suppress speech by... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3269682 Fri, 12 Feb 2010 18:43:31 +0100 3269682 http://www.medworm.com/index.php?rid=3267058&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F2010%2F02%2F12%2Fca-sen-profile-in-courage-chuck-devore-fails-to-vote-during-abel-maldonado-confirmation%2F California Republican Assemblyman Chuck DeVore tweeting about In and Out Burgers instead of voting? Apparently Assemblyman Chuck DeVore, representing an Orange County District was present in the Assembly Chamber during one of two votes yesterday on the “failed?”confirmation of fellow Republican State Senator Abel Maldonado who was appointed to the vacant Lt. Governorship. But, DeVore failed to vote yes or no. Why? I mean DeVore was present in the Assembly Chamber and he had pledged to vote against Maldonado, right? Maybe this tweet from Jon Fleischman explains DeVore’s non-vote: Whatever that means? Chuck do you mean you will not vote because you disagree with a fellow Republican because of a budget vote, a series of votes or why? And, then, if you are opposed to his co... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=3267058 Fri, 12 Feb 2010 16:52:45 +0100 3267058 http://www.medworm.com/index.php?rid=3259244&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTZocaRRHVuE%2F As the controversy over industry influence over doctors and patient care heats up, Fox News journalist John Stossel plans to explore conflicts of interest on an upcoming show. So tomorrow, Feb. 11, he’s invited two outspoken physicians - Tom Stossel (see here) and Arnold Relman - to debate the issue (weather permitting, of course). And it appears that the Association of Clinical Researchers and Educators is concerned the studio audience will not work in its favor. ACRE has been active in the debate by arguing that financial incentives given to docs do not influence treatment and recently fought a proposal in Minnesota to limit industry influence (see here). A founding member of the organization is Thomas Sullivan, who last year gained notice for his criticism of US Senator Chuck Gras... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3259244 Wed, 10 Feb 2010 14:20:24 +0100 3259244 http://www.medworm.com/index.php?rid=3204798&cid=t_307813_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F01%2Fdr-steve-hansen-leads-mormon-medical-group-haiti%2F Orthopedic surgeon Dr. Steve Hansen lead a group of doctors including Drs. Chuck Peterson, Gary Garner, and Craig Nelson from the Church of the Latter Day Saints (Mormons) in a week-long medical mission to Haiti. Lacking any formal aid group organization they dubbed themselves Doctors Without Names. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3204798 Mon, 25 Jan 2010 05:02:17 +0100 3204798 http://www.medworm.com/index.php?rid=3194016&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrMwmpyevORk%2F In his ongoing probe of conflicts of interest involving academic researchers, US Senator Chuck Grassley is now asking the National Institutes of Mental Health director Tom Insel to provide phone records, email and calendar since early 2009, along with correspondence from NIMH staffers in response to Grassley’s investigations. For the past two years, Grassley has pursued conflicts in which academic researchers accept funding from the NIH and industry, and instances where their universities have failed to monitor or report payments. According to current NIH regulations, payments above $10,000 should be reported. In his Jan. 20 letter, Grassley cites several examples… The psychiatry chair at Emory University, Charles Nemeroff, failed to report hundreds of thousands of dollars in p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3194016 Thu, 21 Jan 2010 12:11:26 +0100 3194016 http://www.medworm.com/index.php?rid=3189400&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcSz5onqH0Ls%2F For only the second time, the National Institutes of Health is applying pressure to a university over alleged conflicts of interest involving its researchers. The Baylor College of Medicine in Houston, Texas, is reportedly being eyed for failing to comply with the agency’s conflict of interest policy. Two years ago, the NIH suspended a grant from Emory University and added new conditions on further grants. The latest move was sparked by an article in The Chronicle of Higher Education that pointed out several academics with alleged research conflicts, including Baylor’s Christie Ballantyne, who received over $34,000 for consulting with Merck about its Vytorin cholesterol pill. This prompted US Senator Chuck Grassley to ask the NIH to investigate (see here), since Ballantyne was ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3189400 Wed, 20 Jan 2010 16:43:13 +0100 3189400 http://www.medworm.com/index.php?rid=3185619&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM8WGiKelZAY%2F As Massachusetts voters head to the polls to today to elect the successor to Ted Kennedy, we thought it was interesting that so many healthcare companies - including drugmakers - have lobbyists who last week were hosts or co-hosts of a Washington, DC, fundraiser for Democrat Martha Coakley (here is the invite). As you may have heard, she has run a miserable campaign and her defeat would hinder the Democrats, because the party would have less than 60 votes in the Senate, threatening health care reform. Here is the list, courtesy of The Examiner, of the lobbyists who work for various drugmakers, insurers and related companies: Thomas Boggs, Patton Boggs: Bristol-Myers Squibb; Chuck Brain, Capitol Hill Strategies: Amgen, BIO, Merck, PhRMA; Susan Brophy, Glover Park Group: Blue Cross, Pfize... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3185619 Tue, 19 Jan 2010 14:17:24 +0100 3185619 http://www.medworm.com/index.php?rid=3105277&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUuPe3ZdgOnE%2F The most influential person in the world of business ethics is someone who blew the whistle on Pfizer. John Kopchinski, a former sales rep whose lawsuit led to the record breaking, eye rolling, jaw dropping $2.3 billion settlement, was given this honor by the Ethisphere Institute, a think tank that is dedicated to what it calls “the creation, advancement and sharing of best practices in business ethics, corporate social responsibility, anti-corruption and sustainability.” The choice, of course, would appear to be a determined reminder for Pfizer, and the pharmaceutical industry, in general, that corporate behavior matters. Kopschinski exposed the drugmaker’s illegal sales and marketing efforts to promote its Bextra painkiller. Federal prosecutors, you may recall, announce... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3105277 Sat, 19 Dec 2009 16:32:31 +0100 3105277 http://www.medworm.com/index.php?rid=3101063&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvHCjUUN-yas%2F The federal government has stopped reimbursing a Miami doctor who wrote nearly 97,000 prescriptions for mental health drugs - such as antipsychotics - to Medicaid patients over 18 months, the Associated Press reports. And the case has prompted Chuck Grassley, the Republican Senator from Iowa, to call for a nationwide investigation. Fernando Mendez-Villamil wrote an average of 153 prescriptions a day for 18 months ending in March 2009, according to Grassley. That’s nearly twice the number of the second highest prescriber in Florida, who wrote a little more than 53,000 prescriptions, according to a list compiled by state officials, the AP writes. Grassley, who is a ranking member of the Senate Finance Committee, which oversees Medicare and Medicaid, sent a letter this week to the Depar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3101063 Fri, 18 Dec 2009 11:59:11 +0100 3101063 http://www.medworm.com/index.php?rid=3067312&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVaK7NxxlzzY%2F As part of an ongoing probe into conflicts of interest, the Senate Finance Committee’s Chuck Grassley has sent letters to the American Medical Association, the American Cancer Society and 31 other medical advocacy groups for details about the money they and their board members received from drug and device makers, The New York Times reports. Such funding is often considered proprietary, but critics contend the influence leads them to lobby on behalf of industry, the Times writes. An AMA spokesman tells the paper industry funding comprised less than 2 percent of its budget (see AMA letter) and an American Cancer Society spokesman wrote the Times to say it “holds itself to the highest standards of transparency and public accountability, and we look forward to working with Senator Gra... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3067312 Mon, 07 Dec 2009 23:19:02 +0100 3067312 http://www.medworm.com/index.php?rid=3056616&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F0FApm6G3Mlc%2F Chuck Schumer is perhaps my favorite U.S. Senator because of his endless capacity to make me laugh.  He often reminds me of Inspector Clouseau, the earnest but bumbling detective from the Pink Panther movies. Through an excellent post by Scott Lincome today, I learned not only that official NBA jerseys (those worn by the players) are made for Adidas in upstate New York, but that Senator Schumer is attempting to thwart the company’s decision to move production to Thailand.  I share Scott’s assessment of the absurdity of Schumer’s efforts, but more importantly, I wanted to share this humorous footage of Schumer’s awkward nativist appeal that basketball is an American-centric game….conducted in front of German-born NBA Star Dirk Nowitski’s jersey.  ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3056616 Thu, 03 Dec 2009 21:50:43 +0100 3056616 http://www.medworm.com/index.php?rid=3048343&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDzl9dWlr6fA%2F Recruiting and enrolling patients in clinical trials is just one behind-the-scenes link in the complicated process that results in medications winning regulatory approval and the subsequent marketing to doctors. But like a lot of steps in that process, the clinical trial machinery is coming under scrutiny as questions arise over the extent to which doctors are compensated for their participation. The issue has been the subject of an ongoing investigation by the Senate Finance Committee’s Chuck Grassley, who has probed undisclosed conflicts among various academic researchers who simultaneously receive industry and federal funding. And so the faculty at the Center for Health & Pharmaceutical Law & Policy at the Seton Hall Law School have issued a 62-page paper with some sugge... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3048343 Wed, 02 Dec 2009 14:25:27 +0100 3048343 http://www.medworm.com/index.php?rid=3008399&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFntj9rV2pjM%2F Few universities file required reports to the National Institutes of Health about financial conflicts held by their researchers, and even when such conflicts are reported, universities rarely require researchers to eliminate or reduce conflicts, The New York Times reports. The paper writes that a report showing that 90 percent of universities relied solely on researchers to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research (here is the report). Moreover, half of universities don’t ask faculty members to disclose the amount of money or stock made from drug and device makers, and so the report concludes the potential for extensive conflicts with their government-financed research is of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3008399 Thu, 19 Nov 2009 13:18:48 +0100 3008399 http://www.medworm.com/index.php?rid=3004085&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMxO3b2oIN30%2F This is the thinking - if a college student submits a paper written by someone else, it’s considered plagiarism. But what is it called when an academic researcher submits a journal study that was written, shaped or heavily edited by a medical communications firm? Grassley contends there is little or no difference. And so the Iowa Republican, who sits on the Senate Finance Committee and has spearheaded numerous investigations into the drug and device industries, has written 10 top medical schools to ask what they’re doing about the issue, The New York Times reports. The schools contacted: Harvard, Johns Hopkins, University of Pennsylvania, Washington University, University of California at San Francisco, Duke, Stanford, University of Washington, Yale and Columbia. In explaining ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3004085 Wed, 18 Nov 2009 14:29:28 +0100 3004085 http://www.medworm.com/index.php?rid=3004089&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRL7o8fTHroo%2F Given the controversy over the Arbiter trial, which found Abbott Labs’ Niaspan appeared safer and more effective than Merck’s Zetia as a secondary cholesterol treatment, the Senate Finance Committee’s Chuck Grassley wants to know what the Department of Health and Human Services will do about spending on Vytorin (which is a combination of Zetia and simvastatin). In a letter to HHS Secretary Kathleen Sebelius, he notes that Merck and Schering-Plough (which jointly sold Vytorin before Merck acquired its marketing partner this year) made more than $300 million in 2006 and 2007 through Medicare Part D sales of Vytorin. His point - why is HHS spending all that money now that a second clinical trial has raised questions about Vytorin’s effectiveness. Meanwhile, Forbes notes that t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3004089 Wed, 18 Nov 2009 12:59:27 +0100 3004089 http://www.medworm.com/index.php?rid=2999849&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7PWnZOxv8SQ%2F Who is Thomas Sullivan and why is his name popping up lately? Sullivan is known for a few things - president of Rockpointe, a medical education communications company; a founding member of the Association of Clinical Researchers and Educators, and his Policy and Medicine blog, where he rails against government oversight of the pharmaceutical industry. Besides being an avid defender of CME, he is also a vociferous critic of Chuck Grassley, the Senate Republican who is investigating various pharma issues, including CME. Over the past few days, however, Sullivan has been scrutinized himself. That’s because the Drug Industry Document Archive at the University of California at San Francisco released something Sullivan didn’t want made public - his funding from pharma. In a July 6, 2... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2999849 Tue, 17 Nov 2009 13:21:12 +0100 2999849 http://www.medworm.com/index.php?rid=2967285&cid=t_307813_88_f&fid=35612&url=http%3A%2F%2Ftheknifeman.blogspot.com%2F2009%2F11%2Fsupergroup-guitars.html Currently, mulling over Hendrix, Clapton, Mick Taylor and Chuck Berry...I think there are simply too many legendary guitar players out there.Mick Taylor on show from about 2:50 (Source: The KnifeMan) The KnifeMan blogs http://www.medworm.com/rss/comments.php?id=2967285 Wed, 04 Nov 2009 17:42:00 +0100 2967285 http://www.medworm.com/index.php?rid=2950992&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYp1hnhtvkSA%2F The race between two drug makers to market a generic version of a blockbuster blood thinner has grown so intense that one company hired the Kroll detective and security firm, prompting an inquiry by two key senators, The Wall Street Journal reports. Both Amphastar Pharmaceuticals and Momenta Pharmaceuticals hired high-profile Washington lobbyists as they await FDA approval for generic versions of low-molecular-weight heparin. In 2007, the FDA told Amphastar its prototype chemically matched Lovenox - the only available version. But the FDA unexpectedly set added safety requirements for heparin. Both companies submitted more data. You may recall earlier this year, Amphastar filed a complaint with the FDA against its own Janet Woodcock, saying she had a conflict of interest over heparin due ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2950992 Mon, 02 Nov 2009 13:13:07 +0100 2950992 http://www.medworm.com/index.php?rid=2944100&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fidjr0WaSrfA%2F The controversial psychiatry professor, who was among several high-profile academics targeted by a Senate Finance Committee probe into conflicts of interest involving NIH and industry funding, is taking a new job - chair of the psychiatry department at the Miller School of Medicine at The University of Miami, according to sources familiar with the school. You may recall that Nemeroff, who currently works at Emory University, came to the Senate committee’s attention because he was accepting sizeable consulting fees from Glaxo at the asme that he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (you can read background here and here). Chuck Grassley, an Iowa Repulican who spearheaded the Senate probe, is trying to force universities and the NIH to more... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2944100 Thu, 29 Oct 2009 12:56:04 +0100 2944100 http://www.medworm.com/index.php?rid=2939557&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fidjr0WaSrfA%2F The controversial psychiatry professor, who was among several high-profile academics targeted by a Senate Finance Committee probe into conflicts of interest involving NIH and industry funding, is being considered for a new job - chair of the psychiatry department at the Miller School of Medicine at The University of Miami, according to sources familiar with the school. You may recall that Nemeroff, who currently works at Emory University, came to the Senate committee’s attention because he was accepting sizeable consulting fees from Glaxo at the asme that he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (you can read background here and here). Chuck Grassley, an Iowa Repulican who spearheaded the Senate probe, is trying to force universities and t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939557 Thu, 29 Oct 2009 12:56:04 +0100 2939557 http://www.medworm.com/index.php?rid=2931286&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6qSn-qjUnrs%2F The move is the latest in a long-running effort by the Republican Senator from Iowa, who has been probing undisclosed financial conflicts of interest among academics who simultaneously receive grants from the National Institutes of Health and payments from drug makers for research or speaking. His latest letter to the NIH follows an article in The Chronicle of Higher Education that noted several academics with alleged research conflicts. In particular, he cited Dr. Christie Ballantyne of the Baylor College of Medicine, who received over $34,000 for consulting with Merck about the Vytorin cholesterol pill. At the same, Grassley writes, Ballantyne was listed on several NIH grants concerning cardiovascular studies (here’s one). According to current NIH regulations, which Grassley has ci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2931286 Tue, 27 Oct 2009 15:47:43 +0100 2931286 http://www.medworm.com/index.php?rid=2920360&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F2009%2F10%2F23%2Fcalifornia-gop-assemblyman-chuck-devore-falls-flat-in-california-u-s-senate-fundraising%2F The official filing  for the ending third quarter (September 30, 2009) is now posted over at the Federal Elections Commission although the National Journal had a summary earlier. You can generate your own DeVore FEC report in PDF format here. All Flap knows is that California United States Senator Barbara Boxer is licking her chops at the prospect of EVER running against a Republican candidate with so little monetary support. After all, DeVore has been campaigning for almost a year (as soon as he won re-election to the California Assembly and is term limited out from running for re-election) and has a “NET” cash on hand of $56K compared to Boxer’s $6.35 million. Now, Flap wants to know why Assemblyman DeVore is fibbing to the San Francisco Chronicle when he is statin... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=2920360 Fri, 23 Oct 2009 15:02:06 +0100 2920360 http://www.medworm.com/index.php?rid=2916438&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3YOWAJO8oDk%2F A majority of donations made to the National Alliance on Mental Illness, a big advocacy group, have come from drug makers in recent years, according to Congressional investigators. The disclosure comes after protracted criticism of NAMI for coordinating lobbying efforts with drug makers and pushing legislation that also benefits the pharma industry, The New York Times reports. Last spring, Chuck Grassley, an Iowa Republican on the Senate Finance Committee, sent letters to NAMI (see here) and other disease and patient advocacy groups asking about their ties to drug and device makers as part of his investigation into industry influence on the practice of medicine. One whistleblower lawsuit that was part of Pfizer’s $2.3 billion settlement detailed how Pfizer funded NAMI to promote its... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2916438 Thu, 22 Oct 2009 12:10:04 +0100 2916438 http://www.medworm.com/index.php?rid=2908889&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2grQIyMYetk%2F Why else? Well, there are other reasons to consider. Health benefits, for instance. Maybe a new indication. Or in this day and age of health reform, perhaps cost effectiveness. But that wasn’t the alleged case as revealed in testimony given during recent litigation involving birth defects associated with GlaxoSmithKline’s Paxil antidepressant (the drugmaker was ordered to pay $2.5 million). The interesting exchange below - in which David Healy, a controversial psychiatrist and consistent critic of antidepressant clinical trial data, was questioned - yielded this nugget: one of five reasons offered by Glaxo to investigators to conduct a study of Paxil was ‘image enhancement.’ You know, make the drug appear more desirable in the eyes of health care providers, primaril... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2908889 Tue, 20 Oct 2009 12:30:02 +0100 2908889 http://www.medworm.com/index.php?rid=2785976&cid=t_307813_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F09%2F10%2F7-ways-to-manage-anxiety-on-an-anniversary%2F Most of us circle a few days of the calendar year that we know will be difficult to get through: the anniversary of a death, traumatic event, or even happy occasion. These dates are charged with emotion. September 11 falls under that category for most of us, and especially those living in New York or surrounding areas and families and loved ones of those killed in the terrorist attacks. The one benefit from anniversary anxiety is that we can predict it and therefore prepare for it. Here are 8 ways to do just that. 1. Forecast your emotions. You’ve circled the day. You know it’s coming. Now get honest with yourself about how you might feel on that day. If it’s the anniversary of a death of a loved one, get ready to celebrate that person’s life with joy and sadness. ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2785976 Thu, 10 Sep 2009 19:40:44 +0100 2785976 http://www.medworm.com/index.php?rid=2284346&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FBxOoV0GA-nE%2F Sen. Chuck Grassley, who can always be counted on to stick the federal government’s nose where it doesn’t belong, is criticizing Attorney General Eric Holder’s teeny-tiny steps toward a less oppressive enforcement of drug prohibition. Holder said on Wednesday “that federal agents will target marijuana distributors only when they violate both federal and state law. This is a departure from policy under the Bush administration, which targeted dispensaries under federal law even if they complied with the state’s law allowing sales of medical marijuana.” Grassley says that marijuana is a “gateway” drug to the use of harder drugs and that Holder “is not doing health care reform any good.” As Tim Lynch and I wrote in the Cato Handbook f... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2284346 Fri, 20 Mar 2009 14:11:34 +0100 2284346 http://www.medworm.com/index.php?rid=2263794&cid=t_307813_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FgOtvX_8HppI%2F On Meet the Press last Sunday, Sen. Chuck Schumer (D-NY) said Those on the hard right say, “Cut government spending, let’s go back to the old Reagan days.” Well, the last president who did this when we were in this type of situation was Herbert Hoover.  Herbert Hoover said the government should do nothing when we were in a recession, not a depression.  We did nothing and it related [sic] to a depression. Reality check: Did President Hoover cut federal spending during the recession that became a depression? Not by a long shot.   Source: OMB Federal spending was $3.1 billion (those were the days!) in 1929, the year Hoover took office and the stock market crashed. It rose modestly for two years, then shot up in 1932. It dropped a bit in nominal terms in 1933, though def... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2263794 Thu, 12 Mar 2009 23:56:40 +0100 2263794 http://www.medworm.com/index.php?rid=2086858&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F2009%2F01%2F07%2Fvideo-nbc-news-chuck-todd-loses-his-virginity-to-the-one%2F You mean Barack Obama is ACTUALLY going to answer questions from the White House Press corps? Having watched Chuck Todd for a while, Flap doubts that Obama will be getting too much of a free pass - at least not yet. Likley, “The One” will ignore Chuck. Technorati Tags: Chcuk Todd, Chris Matthews Bookmark/Search this post with: (Source: FullosseousFlap's Dental Blog) FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=2086858 Wed, 07 Jan 2009 19:20:16 +0100 2086858 http://www.medworm.com/index.php?rid=2056344&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F490526529%2F Elsevier is investigating the widely publicized allegation by the US Senate Finance Committee that one of its journals published an article on hormone replacement therapy that was improperly ghostwritten by Wyeth, which was promoting its Prempro med, The New York Times writes. Earlier this month, Chuck Grassley, the ranking Republican on the committee, raised questions about the May 2003 “Editors’ Choice” article in The American Journal of Obstetrics and Gynecology. The article, signed by John Eden, an associate professor at the University of New South Wales, was among articles Grassley cited that were favorable to Wyeth drugs (back story). Grassley charged Wyeth commissioned the articles and had them ghostwritten by a medical writing firm called DesignWrite, but only aft... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2056344 Sun, 21 Dec 2008 14:19:49 +0100 2056344 http://www.medworm.com/index.php?rid=2053203&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F488916084%2F We all need reminders once in a while, but Emory Univeristy psychiatry professor Charles Nemeroff had an unusual way of generating one. On February 9, 2000, he wrote himself an invitation on the letterhead of the Depression and Anxiety journal, which he edited at the time, to write an article to celebrate the 5th anniversary of the introduction of Wyeth’s Effexor antidepressant. For his trouble, Nemeroff offered to pay himself a $3,000 fee, although some handwriting scribbled on the letter indicates Kerry Ressler was later invited to co-author the manuscript and the fee would be split. Moreover, an attached invoice indicates Nemeroff was actually to receive a total of $4,500 - $3,000 for organizing the ‘honorarium’ and $1,500, or half of the fee for the manuscript. Accord... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2053203 Thu, 18 Dec 2008 18:53:42 +0100 2053203 http://www.medworm.com/index.php?rid=2035944&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F482979954%2F Wyeth paid ghostwriters to produce medical journal articles favorable to its Prempro hormone replacement therapy, according to Congressional letters seeking more info about the drugmaker’s involvement in medical ghostwriting, The New York Times reports, adding that at least one article was published even after a federal study found the drug raised the risk of breast cancer. The letters, sent electronically today by Chuck Grassley, the ranking Republican on the Senate Finance Committee, asks Wyeth and DesignWrite, a medical writing firm, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication, the Times writes. “Any attempt to manipulate the scientific literature, that can in turn mis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2035944 Fri, 12 Dec 2008 19:50:02 +0100 2035944 http://www.medworm.com/index.php?rid=2021725&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F478854343%2F The Boston psychiatrist, who is being investigated by the US Senate Finance Committee for allegedly failing to fully disclose payments from drugmakers, defended himself against conflict-of-interest charges in a letter to The Boston Globe. Biederman was responding to reports that newly disclosed court documents indicated he sought funds from Johnson & Johnson to create an institute at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder, the paper writes (back story here and here). In one internal 2002 e-mail, execs at J&J’s Janssen Pharmaceutica, which sells Risperdal, discuss Biederman’s repeated proposals for the drugmaker to help fund a center on pediatric bipolar disorder. “The ratio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2021725 Mon, 08 Dec 2008 21:20:35 +0100 2021725 http://www.medworm.com/index.php?rid=2018096&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F475830594%2F For the past few months, the US Senate Finance Committee has been investigating various high-profile academic researchers for undisclosed conflicts of interest involving payments from pharma for speaking, research and consulting and simultaneously receiving NIH grants. An NIH regulation requires researchers to report to their universities any “significant financial interests” they hold in research financed by the agency - defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings. However, the NIH has been criticized by the Chuck Grassley, the committee’s ranking Republican, for failing ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2018096 Fri, 05 Dec 2008 16:24:47 +0100 2018096 http://www.medworm.com/index.php?rid=1975631&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F460224952%2F Last May, National Public Radio talk-show host Fred Goodwin was, himself, the subject of a great deal of chatter. An episode of his program, “The Infinite Mind,” which is heard on 300 NPR stations, featured three experts who discussed the controversial link between antidepressants and suicide. And all four, including Goodwin, declared that worries about the drugs have been overblown (back story). But there was a catch: Goodwin never pointed out that all three guests had ties to pharma, or that the show received “unrestricted” from drugmakers, including Lilly, which sells Prozac and Cymbalta. The segment, by the way, aired just two months after UK regulators concluded a four-year investigation of Glaxo’s Paxil and found the drugmaker had been aware since 1998 t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975631 Fri, 21 Nov 2008 03:25:45 +0100 1975631 http://www.medworm.com/index.php?rid=1871104&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F416746621%2F For the past several months, the US Senate Finance Committee has been investigating undisclosed conflicts of interest involving academic researchers who receive NIH grants and pharma funding. At issue is whether universities are fulfilling their requirements to adequately monitor these disclosures in an effort to maintain scientific integrity and objectivity (back story here, here, here, here and here. Nature Medicine spoke with Chuck Grassley, the ranking Republican on the committee, about the probe. This is an excerpt… Nature Medicine:What are you hoping to accomplish? Grassley: NIH gives $24 billion worth of grants…The law requires the universities to have their researchers report outside income. We found out the law wasn’t being followed. The universities were not doi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871104 Fri, 10 Oct 2008 12:23:26 +0100 1871104 http://www.medworm.com/index.php?rid=1853828&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F412282361%2F For several years, Charles Nemeroff assured Emory University, where he chaired the psychiatry department, that he wouldn’t accept more than $10,000 in consulting fees from Glaxo, since he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. Why? Since 1995, an NIH regulation has required scientists to report to their universities any “significant financial interests” they hold in research projects financed by the agency. Those are defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities, in turn, are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings (here are the rules). And anxious Emory officials, who condu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1853828 Mon, 06 Oct 2008 00:37:31 +0100 1853828 http://www.medworm.com/index.php?rid=1852735&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F410489215%2F The reason - the psychiatry department chair at Emory University earned more than $2.8 million in consulting arrangements with various drugmakers between 2000 and 2007, but failed to report at least $1.2 million of this income to his university. This oversight violated federal research rules, a point that is central to a widening probe of some 30 academic researchers by the Senate Finance Committee. Since yesterday, we have twice posted items indicating Charles Nemeroff and Emory were caught up in the investigation (look here and here). Now, The New York Times has revealed a detailed account. For instance, the paper writes that Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from Glaxo to comply with federal rules. B... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1852735 Fri, 03 Oct 2008 18:41:15 +0100 1852735 http://www.medworm.com/index.php?rid=1851212&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F409343727%2F The ongoing investigation by the Senate Finance Committee seems to be making some universities a bit, well, sensitive to the activities undertaken by faculty members. You may recall that Chuck Grassley, the commitee’s ranking Republican, is probing pharma and NIH funding given academic researchers - particularly psychiatrists - and whether any conflicts are properly disclosed. So far, the committee has singled out Stanford University’s Alan Schatzberg, Harvard University’s Joe Biederman, Brown University’s Martin Keller, University of Texas’ Karen Wagner and John Rush, and Melissa DelBello at the University of Cincinnati. Charles Nemeroff, the well-known psychiatry chairman at Emory University, has not made the list, but the school appears, nonetheless, to be ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1851212 Thu, 02 Oct 2008 15:19:44 +0100 1851212 http://www.medworm.com/index.php?rid=1829483&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F401963019%2F After more than six years heading the federal behemoth, the radiologist will be leaving at the end of October as part of what he called “the natural cycle of tenures for this positions,” during a teleconference with journalists. “It’s with mixed emotions that I move on.” He is rumored to be in the running to take a top position at Johns Hopkins University, sources says. (Official statement). During his reign, Zerhouni led the development of the “NIH Roadmap for Medical Research,” a $2 billion, five-year plan designed to boost biomedical research by shifting NIH resources on bioinformatics, systems and structural biology, genomic database establishment, and nanomedicine projects, encouraging cross-disciplinary collaboration, and funding clinical and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1829483 Wed, 24 Sep 2008 17:02:32 +0100 1829483 http://www.medworm.com/index.php?rid=1826206&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F401438428%2F In doing so, Lilly becomes the first drugmaker to report how much money is paid to individual docs for consulting, speeches and other activities, the Associated Press reports. The move comes four months after Lilly decided to support a watered-down version of the Physicians Payments Sunshine Act, which would establish a national registry of such payments by drug and device makers (back story). The disclosure will begin in the second half of 2009, and cover payments made in the first half of the year, but Lilly won’t report payments from 2008 or earlier, noting the Sunshine Act doesn’t require such disclosure. Later on, Lilly will expand disclosure to include travel, gifts and entertainment, which the legislation would require to be made public. For now, Lilly will create an Int... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1826206 Wed, 24 Sep 2008 04:19:15 +0100 1826206 http://www.medworm.com/index.php?rid=1788922&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F389612650%2F This time, the ranking Republican on the US Senate Finance Committee is fingering Karen Wagner, a researcher at the University of Texas who worked on a National Institutes of Health study involving Glaxo’s Paxil antidepressant, who allegedly did not disclose more than $150,000 in consulting and speaking fees she received from the drugmaker, according to The Wall Street Journal. Grassley cited Wagner after comparing records from Glaxo and the university. Between 2000 and 2008, she was involved in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety, the paper writes. The university’s legal counsel tells the paper they will look for any discrepancies in Wagner’s disclosure reports, Wagner did not respond to the paper’s request... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1788922 Thu, 11 Sep 2008 12:27:17 +0100 1788922 http://www.medworm.com/index.php?rid=1779677&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F386878184%2F Two months ago, the US Senate Finance Committee widened its probe into conflicts of interest involving drugmakers and federally funded academic researchers to include the American Psychiatric Association, since many of the academics already being investigated happen to be psychiatrists (back story). Among those probed are Brown University’s Martin Keller, Harvard University’s Joe Biederman, Stanford University’s Alan Schatzberg and the University of Cincinnati’s Melissa DelBello. Psychiatrists, of course, prescribe antidepressants and antipsychotics, both of which have stirred controversy. And psychiatrists have frequently shown up at the top of lists of doctors receiving pharma money. Today, the APA sent a letter to Chuck Grassley, the ranking Republican on the co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1779677 Mon, 08 Sep 2008 18:00:00 +0100 1779677 http://www.medworm.com/index.php?rid=1779680&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F386609971%2F For the first time since Stanford University last month reassigned his National Institutes of Health grant to another principal investigator (look here), the chair of the school’s psychiatry department is responding to the episode, which actually began earlier this year when the US Senate Finance Committee named him as an example of federally funded academics with conflicts of interest. You may recall that Schatzberg, who is also president-elect of the American Psychiatric Association, owns about $6 million in stock in Corcept Therapeutics, which is studying the development of mifepristone for treating psychotic depression. He is also a co-patent holder for the drug and he received an NIH grant to oversee the research. Stanford insisted he had no role in dealing with patients or anal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1779680 Mon, 08 Sep 2008 11:50:15 +0100 1779680 http://www.medworm.com/index.php?rid=1769138&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F383216828%2F Under pressure from an ongoing US Senate investigation, the National Institutes of Health last week sent reminders to universities that “proper stewardship of Federal funds includes ensuring objectivity of results by protecting federally-funded research from compromise by FCOI,” or financial conflicts of interest. The August 25 e-mail was written by Norka Ruiz Bravo, the NIH deputy director for extramural research, who last March told The New York Times that “for us to try to manage directly the conflict-of-interest of an NIH investigator would be not only inappropriate but pretty much impossible.” She added that “I think (the system) is working to the extent that people are being honest and I think most people are honest.” Honesty aside, the Senate Finance Co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1769138 Thu, 04 Sep 2008 12:38:08 +0100 1769138 http://www.medworm.com/index.php?rid=1675137&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F352794956%2F The Senate Finance Committee is intensifying its investigation into research grants and conflicts of interest are managed by the National Institutes of Health and universities, whose academic researchers receive both NIH funding and have ties to drugmakers. Yesterday, though, Stanford University and its psychiatry department chair, Alan Schatzberg, came under special scrutiny - again. You may recall Schatzberg owns about $6 million in stock in Corcept Therapeutics, which is studying the development of mifepristone for treating psychotic depression. He is also a co-patent holder for the drug and he received an NIH grant to oversee the research. In response to the charges that Schatzberg failed to properly disclose this tangled web, Stanford issued a statement defending Schatzberg by saying,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1675137 Fri, 01 Aug 2008 16:47:22 +0100 1675137 http://www.medworm.com/index.php?rid=1668704&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F350601005%2F Last month, the US Senate Finance Committee charged that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, who chairs the psychiatry department and owns about $6 million in stock in Corcept Therapeutics, which is studying the development of mifepristone, or RU-486, for treating psychotic depression. In addition to his stock holdings, Schatzberg is also a co-patent holder for the drug, which is best known for inducing abortion, and he received a grant from the National Institutes of Health to oversee the research. In response to the charges that Schatzberg failed to properly disclose this tangled web, Stanford issued a statement defending Schatzberg by saying, among other things, that all conflicts were properly disclosed. Schatzberg &#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1668704 Wed, 30 Jul 2008 15:40:27 +0100 1668704 http://www.medworm.com/index.php?rid=1664627&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F350398994%2F Time to bring out the old trueism from the Morning Mayor: Every brand new day should be unwrapped like a precious gift. So unwrap yours and set aside those concerns about deadlines, meeting and what-not. Meanwhile, we will tend to the official Pharmalot mascot and grab our favorite cup of stimulation. Here goes… Dingell & Grassley Try To Overhaul The FDA (The Wall Street Journal) EU OKs Schering-Plough Anethesia Drug (Yahoo/Reuters) FDA Panel Recommends Roche Arthritis Drug (Yahoo/Reuters) FDA Approves Generic Versions Of Abbott Epilepsy Drug (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1664627 Wed, 30 Jul 2008 11:22:31 +0100 1664627 http://www.medworm.com/index.php?rid=1622999&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F335299832%2F Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly. In recent weeks, the committee has acknowledged focusing on three academic psychiatrists - Harvard University’s Joe Biederman, Stanford University’s Alan Schatzberg and the University of Cincinnati’s Melissa DelBello. Last week, Chuck Grassley, the ranking Republican on the committee, also asked the Am... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1622999 Mon, 14 Jul 2008 18:09:11 +0100 1622999 http://www.medworm.com/index.php?rid=1616429&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F333128131%2F The investigation by the Senate Finance Committee, where Chuck Grassley is the ranking Republican, into the ties between drugmakers and medicine is expanding. After targeting grants issued to academic psychiatrists, Grassley now wants the American Psychiatric Association to open its books for a look-see at pharma funding. Psychiatrists, of course, prescribe antidepressants and antipsychotics, both of which have stirred controversy. And psychiatrists have frequently shown up at the top of lists of doctors receiving pharma money. This week, for instance, Vermont’s Attorney General released its annual report showing that, of the top 100 recipients, psychiatrists received the highest level of payments, and 11 psychiatrists received a total of about $626,000, or approximately 20 percent o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1616429 Sun, 13 Jul 2008 02:42:39 +0100 1616429 http://www.medworm.com/index.php?rid=1561298&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F324104221%2F Last week, the Senate Finance Committee targeted yet another academic for failing to fully disclose potential conflicts involving research funding provided by drugmakers and other financial holdings. The example, which singled out Stanford University’s Alan Schatzberg, is part of a larger investigation into academics who receive funding from both the NIH and pharma for possible violations of federal regulations. At issue are whether universities and NIH are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. In response to the probe, the NIH disclosed it would tighten oversight, but the story is just beginning. Eric Campbell, an associate professor at the Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1561298 Tue, 01 Jul 2008 14:36:45 +0100 1561298 http://www.medworm.com/index.php?rid=1551898&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321279248%2F The investigation by the Senate Finance Committee into academic researchers who simultaneously receive funding from pharma and the NIH - without fully disclosing their payments - has been followed closely on this site. For those of you, however, who enjoy a watching televised version of the saga, or simply missed an item here or there, CBS Evening News ran a segment last night. Here it is… (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551898 Fri, 27 Jun 2008 12:08:44 +0100 1551898 http://www.medworm.com/index.php?rid=1543925&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F319993115%2F In response to sustained public pressure, the National Institutes of Health is now getting set to tighten its oversight on grants awarded academic researchers, whose institutions are required to report any conflicts of interest. Recent examples uncovered by the Senate Finance Committee, however, have embarrassed the NIH and several universities, most notably Harvard University. Over the past several months, the committee has disclosed instances where academic researchers at Harvard, Stanford University and the University of Cincinnatti accepted funding from both the NIH and various drugmakers, but failed to fully disclose industry payments. Universities are supposed to monitor researchers and the NIH is supposed to monitor the universities for conflicts involving payments exceeding $10,000... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1543925 Wed, 25 Jun 2008 21:03:01 +0100 1543925 http://www.medworm.com/index.php?rid=1543928&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F319828349%2F The US Senate Finance Committee charges that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, who chairs the psychiatry department at Stanford University and who owns about $6 million in stock in Corcept Therapeutics, which that participates in a National Institutes of Health study he oversees. This is the latest such case involving high-profile academics, who receive funding from both the NIH and industry, to be investigated by Chuck Grassley, the ranking committee Republican, for possible violations of federal regulations. At issue are whether universities are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. Earlier this month, he targeted three Harvard University psychiatrists, including... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1543928 Wed, 25 Jun 2008 16:34:27 +0100 1543928 http://www.medworm.com/index.php?rid=1526772&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F314862563%2F This is a question the US Senate Finance Committee is trying to answer as part of an investigation into Medicaid drug reimbursements. A letter was recently sent to Hawthorn Pharmaceuticals to ask about allegations the little-known drugmaker has been receiving improper government payments for its drugs, including Dytan, a cough-and-cold med. The inquiry comes as the committee tries to determine how and why retroactive changes were made to the database used for Medicaid reimbursement for Dytan and other drugs, such as Avandia and Vytorin. The committee also wrote Kerry Weems, who heads the Center for Medicare and Medicaid Services, to find out who maintains and updates the database, and whether reimbursement decisions were affected by the changes. (This is the letter). According to the commi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1526772 Wed, 18 Jun 2008 20:03:40 +0100 1526772 http://www.medworm.com/index.php?rid=1522442&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F313081789%2F Last week, US Senator Chuck Grassley called for a probe into Glaxo and the FDA over their handling of the Paxil antidepressant. At issue are the long-standing allegations that the drugmaker knew about suicide risks in children for nearly 15 years but obscured evidence. In demanding the probe, Grassley cited a report prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report was unsealed earlier this year, but was missing some pages. Last week, those pages became available and include a section that describes in some detail how Glaxo allegedly manipulated so-called placebo suicides. These are deaths that occur among patients who are taken off other meds so they can participate in a trial. “The ration... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1522442 Mon, 16 Jun 2008 12:01:53 +0100 1522442 http://www.medworm.com/index.php?rid=1516429&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F2008%2F06%2F13%2Fdrill-here-drill-now-pay-less%2F Chuck Norris for AmericanSolutions.com Go to AmericanSolutions.com and sign the petition: We, therefore, the undersigned citizens of the United States, petition the U.S. Congress to act immediately to lower gasoline prices (and diesel and other fuel prices)* by authorizing the exploration of proven energy reserves to reduce our dependence on foreign energy sources from unstable countries. Over 700,000 have already signed the petition. So, get over there and do it. Flap knows you will be glad you did. (Source: FullosseousFlap's Dental Blog) FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=1516429 Fri, 13 Jun 2008 17:41:13 +0100 1516429 http://www.medworm.com/index.php?rid=1512326&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F310519956%2F The Republican Senator from Iowa wants the agency to “carefully scrutinize” info from Glaxo after reviewing a report about suicide risks among adults using the antidepressant. Chuck has also asked the FDA to review findings released earlier this year by UK regulators, which charged the drugmaker with knowing about suicide risks in children since 1998, but failed to pursue criminal charges. The report cited by Grassley was prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report, which was unsealed earlier this year, asserts that Glaxo obscured suicide risks associated with Paxil for 15 years or more. “The British counterpart to our country’s FDA found that GlaxoSmithKline withhel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1512326 Thu, 12 Jun 2008 16:39:54 +0100 1512326 http://www.medworm.com/index.php?rid=1509074&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F309568758%2F Last month, Joe Barton, the ranking Republican on the House Energy and Commerce Committee, demanded info that would explain a drop in arrests and convictions by the Office of Criminal Investigations. Now, Chuck Grassley, the ranking Republican on the Senate Finance Committee, wants to know if cases were dropped due to influence from other FDA officials, The Wall Street Journal writes. The moves follow a report released last winter by House Republicans showing the FDA isn’t bouncing researchers and drugmakers that commit crimes when seeking approval for meds. Grassley cites the scandal over the Sanofi-Aventis antibiotic, Ketek. At issue is concern that OCI is, instead, overly emphasizing drug-abuse cases, such as OxyContin, and its efforts often duplicate probes by the Drug Enforcement Ad... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1509074 Wed, 11 Jun 2008 11:43:09 +0100 1509074 http://www.medworm.com/index.php?rid=1501502&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F307089180%2F A Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given Congressional investigators, The New York Times reports. By failing to report income, the psychiatrist, Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Timothy Wilens, may have violated federal and university research rules governing conflicts of interest, US Senator Chuck Grassley, an Iowa Republican tells the Times, since some of their research is financed by government grants. Grassley has been investigating the interplay between academics who receive gra... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1501502 Sun, 08 Jun 2008 01:51:37 +0100 1501502 http://www.medworm.com/index.php?rid=1488699&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F303105552%2F Last week, Mark Thornton, a senior vp with GenVec, a small drugmaker that is developing a cancer med, among other drugs, wrote an editorial in The Wall Street Journal criticizing Chuck Grassley, the ranking Republican on the Senate Finance Committee, for asking the GAO to probe the FDA over approval of surrogate endpoints. We pointed out that Thornton failed to disclose his job, but did identify himself as a former FDA medical officer and president of the Sarcoma Foundation of America, prompting a vigorous debate on this site (please see the comments). Today, Grassley issued a statement chastising Thornton for failing to make the disclosure, and for incorrectly describing his reasons for a GAO probe. “…Thornton mischaracterizes and protests my asking the Government Accountabili... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1488699 Mon, 02 Jun 2008 17:17:17 +0100 1488699 http://www.medworm.com/index.php?rid=1478213&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300816851%2F In an impassioned editorial in The Wall Street Journal this morning, former FDA medical officer Mark Thornton lashed out at Chuck Grassley, the ranking Republican on the Senate Finance Committee, for asking the General Accountability Office to launch an inquiry into whether the FDA was correct to grant accelerated approval for Genetech’s Avastin cancer med. The move, he wrote, “will have a catastrophic effect on America’s ability to develop new drugs.” At issue is whether the FDA should use surrogate endpoints as the basis for approval. That’s what the agency did three months ago by rejecting an advisory panel recommendation and approving Avastin for metastatic breast cancer. Tests found the drug slowed tumor growth, even though Avastin wasn’t shown to exten... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1478213 Thu, 29 May 2008 22:49:08 +0100 1478213 http://www.medworm.com/index.php?rid=1461241&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295879862%2F Last fall, a bill was introduced in the Senate called the Physicians Payments Sunshine Act that would require drug and device makers to disclose the amount of money they give docs through payments, gifts, honoraria, travel and other means. And just as a watered-down version was revealed, Lilly declared its support. Whether other drugmakers will follow remains to be seen. One reported sticking point - exemptions sought for payments to docs who do clinical research. But as part of a settlement last fall with the Department of Justice, five device makers agreed to post consultant payments on their web sites. Meanwhile, a few weeks ago, a dozen drug and device makers told Chuck Grassley, the Iowa Republican who co-sponsored the Senate bill, they would disclose grants to outside groups. Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461241 Thu, 22 May 2008 15:48:35 +0100 1461241 http://www.medworm.com/index.php?rid=1461242&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295820027%2F Depends who you ask, of course. But everyone seems to love a list and so the latest ranking from a trade magazine offers an interesting - some may say curious - mix of ceo’s, politicians, regulators, scientists, academics and trade group types. There was no special ranking for controverisal, but Glaxo’s newly retired ceo JP Garnier got as high as No. 22 and Fred Hassan, who runs Schering-Plough, was named No. 32. The FDA’s Janet Woodcock garnered the 18th position, although her boss, the beleaguered FDA commish Andy von Eschenbach, didn’t rank at all. So much for making an impact, Andy. But NICE chair Michael Rawlins ranked No. 5. Who else scored? Carl Icahn shows up as 26th. Cass Wheeler of the American Heart Association finished at No. 36. Merck’s Dick Clar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461242 Thu, 22 May 2008 13:23:25 +0100 1461242 http://www.medworm.com/index.php?rid=1458440&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F%3Fp%3D7017 Senators John McCain and Joe Lieberman In today’s Wall Street Journal, Senator Joe Lieberman of Connecticutt excoriates Senator and presumptive Democrat Presidential candidate Barack Obama and the Democrat Party over their evolution of foreign policy. Today, less than a decade later, the parties have completely switched positions. The reversal began, like so much else in our time, on September 11, 2001. The attack on America by Islamist terrorists shook President Bush from the foreign policy course he was on. He saw September 11 for what it was: a direct ideological and military attack on us and our way of life. If the Democratic Party had stayed where it was in 2000, America could have confronted the terrorists with unity and strength in the years after 9/11. Instead a debate soon b... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=1458440 Wed, 21 May 2008 14:27:40 +0100 1458440 http://www.medworm.com/index.php?rid=1366895&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F268380895%2F File this under ‘Say Uncle.’ A dozen drug and device makers have told Chuck Grassley, the Iowa Republican, that they have plans or are working on plans to publicly disclose grants to outside groups, and the details will be provided on each company’s Web sites, the Associated Press reports. In particular, Grassley is interested in money spent on continuing medical education. Recently, Grassley asked 15 companies whether they planned to do what Lilly does, which is disclose its grants to such programs. And the responses are in. They are wide-ranging and sometimes vague, but mostly what the senator wanted to hear - many say they will go beyond disclosing CME grants and will also disclose payments to patients advocacy groups such as the American Heart Association or the Ameri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1366895 Fri, 11 Apr 2008 13:48:41 +0100 1366895 http://www.medworm.com/index.php?rid=1354206&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F265742239%2F He’s an elected official in Washington DC, who regularly skewers this or that drugmaker with letters seeking all kinds of info. His hearings can be eventful. And his press releases don’t mince words. Who is he? If you guessed Chuck Grassley, Bart Stupak or Henry Waxman you could be forgiven. But in a piece by Congressional Quarterly about the FDA and its many woes, John Dingell, the Michigan Democrat who heads the House Energy and Commerce Committee, sounds off more than anyone else. The agency, CQ notes, has undergone a series of congressionally mandated changes over the past two decades, often in response to problems discovered in food or drug supplies. But compared with what lawmakers are planning now, those have been fairly modest. Now, CQ writes, there is reason to believe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1354206 Mon, 07 Apr 2008 16:01:15 +0100 1354206 http://www.medworm.com/index.php?rid=1347611&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263545183%2F Let’s take one problem at a time. First, there are fresh concerns over potentially troubling safety data from a late-stage study of the biotech’s drug for postmenopausal osteoporosis, known as denosumab. Wall Street is worried because results show the med increased bone density in both early and late stage postmenopausal women, but patients had a higher rate of infections requiring hospitalization. Amgen says its investigators don’t believe the higher infection rate is related to the drug, noting that additional studies involving patients undergoing cancer therapy, who are typically more susceptible to infection, didn’t yield higher infection rates. Just the same, Amgen shares fell. “We caution…that if not a regulatory risk, such data included in an even... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347611 Thu, 03 Apr 2008 20:23:09 +0100 1347611 http://www.medworm.com/index.php?rid=1175042&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F222473058%2F The Republican from Iowa, who is the ranking member of the US Senate Finance Committee, is asking Schering-Plough and Merck to explain when they first unblinded their controversial Enhance study data, and to account for sales and payments made for the cholesterol drug to Medicaid. “In Iowa City, generic (Zocor) costs $54.54 for a month’s supply while Vytorin costs $112.46. It’s fair to assume the public would have benefited from knowing that a less expensive drug works just as well. Instead, people in Iowa and elsewhere paid more for nearly two years, while industry leaders sat on a scientific study that would have revealed this information,” he says in a statement. Like the House Energy & Commerce Committee, Grassley is responding to the scandal over the two-year delay in rel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1175042 Thu, 24 Jan 2008 20:03:17 +0100 1175042 http://www.medworm.com/index.php?rid=1075147&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F196294019%2F The Republican from Iowa and ranking member of the Senate Finance Committee is turning his sights to nursing homes. After reading how antipsychotics are overprescribed and Medicaid picks up the tab, Chuck wants the Inspector General for the Department of Health and Human Services to investigate patient safety, taxpayer liability and off-label usage. “Along with overall quality of care provided to a nursing home resident, it’s of tremendous concern that federal programs are paying for prescription drugs that could be unnecessary or potentially harmful for people living in nursing homes,” Grassley says in a statement. “Independent scrutiny needs to be given to the prescribing practices going on with this very vulnerable population and what’s motivating those practices.” Grassley ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1075147 Thu, 06 Dec 2007 20:52:31 +0100 1075147 http://www.medworm.com/index.php?rid=992034&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F177326643%2F Which new rules? Well, the US Patent and Trademark Office on Nov. 1 will implement new rules, including one concerning the continuation of patent applications. What’s that? Current US patent law allows an inventor to file several different types of patent applications to cover new improvements to their inventions, or to cover different aspects of their inventions. One type is a continuation. You may recall that Glaxo filed a lawsuit against the PTO, claiming the new rules are arbitrary and will prevent it from pursuing patent applications and obtaining patents on or more of its inventions, especially since the drugmaker has hundreds of various types of applications in the works. In essence, Glaxo fears the new rules will make it harder to make such filings, therefore threatening its... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=992034 Tue, 30 Oct 2007 19:29:40 +0100 992034 http://www.medworm.com/index.php?rid=976542&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174549445%2F The findings contained in the 11-page warning letter, which the agency posted on its web site late today, have mostly been aired previously. For those who don’t recall, though, the Ketek antibiotic was at the center of a scandal in which Aventis - which was later bought by Sanofi - was tagged for failing to properly conduct its clinical trials. And the FDA was similarly chastened for a sloppy review process. Of course, hindsight is a wonderful thing. And so the FDA now criticizes the drugmaker for failing to ensure investigators were in compliance and for failing to follow-up problems with data analysis and documentation; failing to monitor clinical trials; failing to select qualified investigators; and failing to ensure protocols were followed according to its IND. A key example cit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=976542 Wed, 24 Oct 2007 22:34:27 +0100 976542 http://www.medworm.com/index.php?rid=779226&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F140614084%2F Chuck Grassley, the Republican senator from Iowa, will propose a bill requiring drugmakers to disclose payments to docs for consulting, lectures and seminar attendance, The New York Times reports. Grassley is one of several lawmakers to propose a federal registry. Minnesota, Vermont and Maine have similar registries; other states are considering them. In a speech on the Senate floor on Thursday, Grassley said he’s begun an investigation, noting most universities require academic researchers to disclose such payments. “I have sent letters to a handful of universities to understand how well such a reporting system actually works,” he said, adding that universities generally keep this info secret from patients, who have no way of knowing whether their doctor is on a drugmaker’s pa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=779226 Sat, 04 Aug 2007 12:16:38 +0100 779226 http://www.medworm.com/index.php?rid=755760&cid=t_307813_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F136999483%2F Yet another FDA medical reviewer allegedly was harassed from the Avandia review for raising red flags, according to a letter written yesterday by US Senators Chuck Grassley and Max Baucus to FDA commish Andy von Eschenbach. Here’s a key portion… “During a recent interview with Finance Committee staff, a senior medical officer in the Office of New Drugs (OND), who at one point was the primary reviewer for Avandia, told staff investigators that s/he was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia. Since 2005, the senior medical officer believed that there was enough evidence to support a black box warning regarding the risk of CHF. Interestingly, the senior medical officer’s removal from the review happ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=755760 Tue, 24 Jul 2007 21:31:28 +0100 755760 http://www.medworm.com/index.php?rid=587783&cid=t_307813_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F114004473%2Fuh-oh-chuck-they-aint-undahstanding-you.html I've had a couple people indicate confusion regarding the meaning of the titles of my posts that include "Uh-Oh Chuck They Out to Get Us Man"(1, 2, 3, 4, 5)."Uh-Oh Chuck They Out to Get Us Man" is the opening lyric from the opening track (You're Gonna Get Yours) from the classic Public Enemy album Yo! Bum Rush the Show. Chuck D was the main voice in Public Enemy (not to neglect Flava Flav's notable contributions -- including the aforementioned opening lyric), and one of the people discussed in the posts is named Charles, which could be abbreviated to Chuck, though I don't believe the Charles in my posts goes by Chuck. I wanted to find some way to throw in a PE lyric to my posts, so I did, even if it was a stretch. Next question... (Source: Clinical Psychology and Psychiatry: A Closer Look) Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=587783 Fri, 04 May 2007 00:12:00 +0100 587783 http://www.medworm.com/index.php?rid=477770&cid=t_307813_125_f&fid=34819&url=http%3A%2F%2Fflapsblog.com%2F%3Fp%3D4597 In one of the worst pre-announcement presidential campaign speeches Senator Chuck Hagel fades into political oblivion. And another GOP politico is getting ready to run for his Senate seat that is up in 2008. Adios…… Previous: The Michael Ramirez Files Technorati Tags: MichaelRamirez, ChuckHagel (Source: FullosseousFlap's Dental Blog) FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=477770 Sat, 17 Mar 2007 15:06:02 +0100 477770