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 'bart'. Sat, 03 Sep 2011 02:10:45 +0100 http://www.medworm.com/index.php?rid=5130734&cid=t_126582_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FC8uOd_7qKvg%2F By Jim HarperOfficials in London are looking everywhere but the mirror for places to affix blame for the recent riots. Beyond the immediate-term answer, individual rioters themselves, the target of choice seems to be “social media.” Prime Minister David Cameron is considering banning Facebook, Twitter, and Blackberry Messenger to disable people from organizing themselves or reporting the locations and activity of the police. Nevermind substantive grievance. Nevermind speech rights. We’ve got scapegoats to find! [Events like this are nothing but a vessel into which analysts pour their ideological preconceptions, so here's a sip of mine: Just like a spoiled child doesn't grow up to be a gracious and kind adult, a population sugar-fed on entitlements doesn't become a meek an... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=5130734 Mon, 15 Aug 2011 12:45:47 +0100 5130734 http://www.medworm.com/index.php?rid=4704959&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOvRuuYAAJLA%2F And the revolving door keeps revolving. Former Congressman Bart Stupak, who gained a high profile and occasional notoriety for his watchdog approach toward the pharmaceutical industry and the FDA, has just signed on as a legislative and government affairs partner with Venable, a law firm that has a sizeable practice helping drug and device makers. “I’ve had numerous contacts with Venable partners over the years and am excited about helping my new colleagues and the firm’s clients navigate choppy congressional waters,” says Stupak, a former police officer, Michigan state trooper and nine-term congressman, in a statement e-mailed to us. This will be a decidedly different role for Stupak. As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704959 Mon, 11 Apr 2011 16:41:59 +0100 4704959 http://www.medworm.com/index.php?rid=4566139&cid=t_126582_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F09%2Fhomer-simpson-and-the-8-attitudes-of-mindfulness%2F I’ve long been a fan of Elisha Goldstein’s work on mindfulness because, more than any author on that topic, he seems to communicate the practice in a way that doesn’t totally overwhelm me and make me want to run the other way. With Forrest Gump. I know this isn’t a very sophisticated image, but I keep going back to Homer Simpson in the Simpsons movie on his roof trying to hammer down the roofing, and the cameras zero in on the nail as he says to Bart, “Steady …. Steady … Steady …” and then he whacks the hell out of something: his eyeball instead of his thumb. I can’t help but compare that image to how I do meditation. I start out right: easy … easy … but then I somehow getting really turned around. Kind of like my son David who, for Halloween this year, was ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4566139 Wed, 09 Mar 2011 14:00:40 +0100 4566139 http://www.medworm.com/index.php?rid=4361080&cid=t_126582_109_f&fid=36089&url=http%3A%2F%2Fthesituationist.wordpress.com%2F2011%2F01%2F17%2Fpatriots-loss-poetic-justice%2F Sal Paolantonio interviewed Bart Scott after the Jets beat the Patriots and Scott describe the win as  “poetic justice” that showed “what kind of defense, what kind of team this was.” Scott warned anyone who’s going to “talk crap about us” that they’ll play for it.  The video is here. Those comments, as well as Deione Branch’s description of the Jets as “classless” put us in mind of the following Situationist post, published originally on February 5, 2008 (here). In case you hadn’t heard, the New England Patriots played their worst game of the season last night. A team that had savored, not merely defeating, but blowing out their opponents failed in their quest for perfection. For at least a little longer, the 1972 Miami Dolphins will hold onto thei... The Situationist blogs http://www.medworm.com/rss/comments.php?id=4361080 Mon, 17 Jan 2011 18:55:46 +0100 4361080 http://www.medworm.com/index.php?rid=4277958&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxWGxZrIn9t4%2F As promised, a handful of House Democrats have introduced legislation that would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US. The bill would crreate an up-to-date registry of all domestic and foreign facilities serving the US; generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs; require parity between foreign and domestic inspections; prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections; prohibit drugs from entering the US if safety documentation is lacking; requires manufact... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277958 Tue, 21 Dec 2010 14:38:54 +0100 4277958 http://www.medworm.com/index.php?rid=4225251&cid=t_126582_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fpregnancy-as-a-pre-existing-condition%2F2010.12.03 Women who own individual healthcare policies, please take note. Should you become pregnant in the future, your individual healthcare policy might not cover your pregnancy. A recent article in the Los Angeles Times by Michelle Andrews was revealing. Andrews described the plight of a North Carolina biology teacher who subsequently left teaching after the birth of her twins. She became a small business owner and was covered under individual health insurance policies. However, when she became pregnant again, she had a rude awakening. Despite paying an insurance premium of $400 per month, her pregnancy wasn’t covered unless she had paid for a special rider, prior to becoming pregnant. Since half of all pregnancies are “unplanned” how can you pay for coverage six months in advance of an u... Better Health blogs http://www.medworm.com/rss/comments.php?id=4225251 Fri, 03 Dec 2010 13:00:20 +0100 4225251 http://www.medworm.com/index.php?rid=3915286&cid=t_126582_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=3460395&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr4doEN28UV4%2F The answer is unclear, although no doubt many pharma execs and FDA officials won’t miss Bart Stupak, a Michigan Democrat who is retiring from Congress after a nasty brawl over health care reform and, in particular, abortion coverage (background here). As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee, Stupak regularly took on safety issues. Along with John Dingell, who formerly headed the House committee, Stupak investigted Merck and Schering-Plough for allegedly delaying the release of unfavorable clinical trial data for their Vytorin cholesterol med (see here and here). He also subpoenaed FDA investigators for approving the Ketek antibiotic, despite knowing a key safety study was fraught with problems; Sanofi-Aventis execs wer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3460395 Mon, 12 Apr 2010 12:21:04 +0100 3460395 http://www.medworm.com/index.php?rid=3460364&cid=t_126582_136_f&fid=37852&url=http%3A%2F%2Fdonnatrussell.com%2F2010%2F04%2F11%2Fon-the-c-street-where-you-live%2F New cartoon by Trussell & Trussell on AOL’s Politics Daily. On the C Street Where You Live. Filed under: Politics Daily Tagged: bart stupak, c street, chaos theory, jeff sharlet, john ensign, lobbyist, political cartoon, sam brownback, the family, tom coburn (Source: Donna Trussell) Donna Trussell blogs http://www.medworm.com/rss/comments.php?id=3460364 Sun, 11 Apr 2010 17:37:59 +0100 3460364 http://www.medworm.com/index.php?rid=3225013&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcwGhX8k34Sw%2F Hello, everyone. Nothing like a brisk Sunday morning to move you to curl up and catch up on some reading. Here on the sunny but quite cold Pharmalot corporate campus, we are doing just that. And, of course, quaffing a cup or three of needed stimulation. Later, we hope to take the official Pharmalot mascot for the usual constitutional. Whatever you do today, we hope it is enjoyable. Meanwhile, here are a few items to keep you fresh. Have a great time… GLAXOSMITHKLINE WILL CUT UP TO 4,000 JOBS as part of its plans to restructure its workforce and focus increasingly on emerging markets, according to The Times of London. The bulk of the cuts will be in America and Europe, and are part of the drugmaker’s efforts to shift resources away from low-growth territories into parts of the world... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3225013 Sun, 31 Jan 2010 16:17:48 +0100 3225013 http://www.medworm.com/index.php?rid=2240787&cid=t_126582_113_f&fid=34621&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FHealthcareGuy%2F%7E3%2FeWsKRta6yoY%2F484 Bart Collet posted a comment to Dr. Rowley’s recent guest article on interoperability – he said the following diagram is a great way to show how inflexible many healthcare IT systems are these days: I love the picture, thanks Bart. Too many of our healthcare IT systems look like the device on the bottom – to make matters worse, many vendors don’t even have the three button Bart has in his photo. (Source: The Healthcare IT Guy) The Healthcare IT Guy blogs http://www.medworm.com/rss/comments.php?id=2240787 Thu, 19 Feb 2009 13:49:46 +0100 2240787 http://www.medworm.com/index.php?rid=2017854&cid=t_126582_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F12%2Fchange-at-fda-we-can-believe-in.html Some potentially promising news from Washington:Bart Stupak, a Michigan Democrat who holds a key post on the House committee that oversees the Food and Drug Administration (FDA) and a frequent critic of that agency's mishandling of various issues on food and drug safety, has apparently written a letter to President-Elect Barack Obama asking him to avoid naming any current officials of FDA to lead the agency.Janet Woodcock, the current FDA deputy commissioner and a 20-year FDA employee, is favored by the pharmaceutical industry to oversee the FDA, in part, because she subscribes to the view that the FDA should be a "partner" to the industries the agency regulates. However, as an agency responsible for ensuring public health, that is the wrong view to have; the relationship need not be adver... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=2017854 Fri, 05 Dec 2008 14:15:00 +0100 2017854 http://www.medworm.com/index.php?rid=2018101&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F475641625%2F Bart Stupak, a Michigan Democrat who holds a key post on the House committee that oversees the FDA, wrote President-elect Barack Obama to urge him to to avoid naming any current FDA officials to lead the agency, even temporarily. And he made a point of singling out FDA deputy commish Janet Woodcock, according to The Wall Street Journal. Congressional aides tell the paper that Democratic officials have discussed naming Woodcock, a longtime FDA official, as interim head after FDA commish Andy von Eschenbach leaves next month. And pharma lobbyists have also floated Woodcock as either interim or permanent FDA chief (here is Stupak’s letter). But in a letter this week to Obama, Stupak wrote, “I would encourage you not to appoint any current senior FDA employee as Commissioner or Int... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2018101 Fri, 05 Dec 2008 12:02:25 +0100 2018101 http://www.medworm.com/index.php?rid=1985168&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F463878507%2F The consensus last week was that the upcoming change at House Energy & Commerce Committee, where California Democrat Henry Waxman will replace Michigan Democrat John Dingell, is something of a wash for pharma and the FDA. That’s because both men were known to be tough on drugmakers and regulators alike, and have launched numerous investigations into pricing, marketing and safety issues. But it may not be that simple, at least in the short run. The changeover, which made for compelling intrigue on Capitol Hill, may actually cause efforts already under way by the House Committee on Oversight and Government Reform to languish. Among the topics it explored: Glaxo’s Avandia diabetes pill, FDA enforcement, preemption and Medicare Part D pricing. In fact, whether the committee co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1985168 Mon, 24 Nov 2008 13:23:10 +0100 1985168 http://www.medworm.com/index.php?rid=1834803&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F404125989%2F The Senate Special Committee on Aging sent a letter today to the House Energy and Commerce Committee Subcommittee on Oversight and Investigations suggesting they collaborate on their investigations into direct-to-consumer advertising of both prescription drugs and medical devices. The Senate Aging committee recently held hearings on DTC ads for devices in a bid to get the FDA to apply the same level of scrutiny given DTC ads for prescription drugs (back story). A collaboration would allow the committtees to coordinate their efforts. “I’m aware that your subcommittee staff has done outstanding work in uncovering deceptive and misleading DTC ads sponsored by the drug industry, which has spent billions of dollars on such marketing efforts during the past decade or so,” Herb Kohl, wh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834803 Fri, 26 Sep 2008 21:16:59 +0100 1834803 http://www.medworm.com/index.php?rid=1790483&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F391089261%2F Two House Democrats are investigating advertising claims by Wyeth that promote its Centrum Cardio vitamin as a cholesterol-lowering product. The inquiry is part of an ongoing investigation of direct-to-consumer advertising for pharmaceutical products by the House Energy & Commerce Committee and its Oversight and Investigations subcommitee. John Dingell and Bart Stupak, both of Michigan, are seeking related documents following TV ads touting the vitamin as “the only complete multivitamin that can lower cholesterol,” according to a letter sent Wyeth ceo Bernard Poussot. (The letter is not yet available on the committee web site, but we were sent a text copy by e-mail). Centrum Cardio is advertised as the “First and only complete multivitamin that lowers cholesterol,”... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790483 Fri, 12 Sep 2008 23:40:43 +0100 1790483 http://www.medworm.com/index.php?rid=1760166&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F381599279%2F Two weeks ago, the House Energy & Commerce Committee stepped up its probe of the controversial cholesterol pill by demanding Merck and Schering-Plough, which jointly market Vytorin, turn over documents relating to the SEAS trial and its analysis. This trial, you may recall, turned up an unexpected link to cancer and cancer-related deaths (back story). In particular, the committee wanted the analysis by Oxford University’s Richard Peto, who is running one of two larger Vytorin trials and maintains the cancer findings are a bizarre fluke. His report, which the drugmakers insist they did not underwrite, was submitted to the FDA. But the drugmakers refused to provide the report without “assurances” it wouldn’t be released to the public. Instead, the committee was told to get t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1760166 Tue, 02 Sep 2008 20:58:13 +0100 1760166 http://www.medworm.com/index.php?rid=1723653&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F371073340%2F The circumstances surrounding the recently released SEAS study, which unexpectedly revealed a few dozen cases of cancer and cancer-related deaths among patients given the controversial Vytorin cholesterol pill, is apparently angering the House Energy & Commerce Committee. As part of its ongoing investigation into how Merck and Schering-Plough handled clinical trial data surrounding the Enhance trial, the committee is now questioning conflicting data from the SEAS trial. For instance, the SEAS press release from Monday, July 21, 2008, indicated that there were 93 cancer cases among those taking Vytorin and 65 among those taking placebo. But a press release issued by Oxford University’s Clinical Trials Service Unit indicated there were 102 cancer cases among Vytorin users and 67 in t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1723653 Thu, 21 Aug 2008 16:40:00 +0100 1723653 http://www.medworm.com/index.php?rid=1671775&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F351935987%2F The House Energy & Commerce Committee, which is investigating the “potentially premature” return to market of ProHeart 6, a controversial drug used to prevent heartworm in dogs, notes that the med contains moxidectin. And the ingredient is also found in a drug being tested on humans in Ghana for preventing and treating river blindness. Wyeth hopes its drug is better than Mectizan, a widely used Merck med. Why does the committee care? ProHeart 6 was yanked in 2004 after being linked to an unusually high rate of deaths and serious side effects following a review by an FDA vet. However, Wyeth then launched a secret investigation into the vet; raised conflict-of-interest charges against her at the FDA; and implicitly threatened FDA officials that further action would be pursue... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1671775 Thu, 31 Jul 2008 21:17:19 +0100 1671775 http://www.medworm.com/index.php?rid=1640310&cid=t_126582_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F341251060%2F The first thing I have to say about being at BlogHer was that, because I didn’t have to keep looking for a boy at my back (not that I didn’t sometimes turn and scan the room for him; it’s a reflex)—-because I was on my own, I got a chance to look at some things a little more. I got in at the San Francisco Airport mid-Friday morning and took BART, and was briefly disoriented. When I growing up, BART ended at Daly City, not the airport, and went to Fremont, Concord, or Richmond. Now it goes out to Pittsburg/Bay Point and Millbrae and to Dublin/Pleasanton, places not unfamiliar to me but not familiar as BART stops. As I waited for the train, I remembered how, with my sister and father and Yeh-Yeh, my grandfather, we all took a ride on BART when it opened—a ride t... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=1640310 Mon, 21 Jul 2008 06:25:09 +0100 1640310 http://www.medworm.com/index.php?rid=1546982&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320644750%2F At a time when the FDA is routinely criticized for awarding large bonuses to senior officials but measly incentives to underlings, the agency doled out more than $35 million in incentive pay for fiscal year 2007, a 29 percent jump from the previous year, according to a new analysis. Seventeen of the top paid officials made more than $200,000, according to documents sent by Stephen Mason, the FDA’s acting assistant commissioner for legislation, to the House Energy and Commerce Committee, which is investigating the FDA’s bonus system. Here is his letter. To prevent FDA employees from going to pharma and other industries, which can pay double, Congress had expanded a cash bonus program to help retain government workers. “The agency employs a very knowledgeable, experienced a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1546982 Thu, 26 Jun 2008 16:24:46 +0100 1546982 http://www.medworm.com/index.php?rid=1543924&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320012374%2F Three weeks after the FDA allowed Wyeth to begin marketing what the drugmaker calls a reformulated version of its heartworm med on a restricted basis, a pair of dogged Congressional reps want the agency to justify its decision. ProHeart 6, you may recall, was yanked four years ago after being linked to an unusually high rate of deaths and serious side effects. The episode spoke poorly of the FDA, though. In 2003, an FDA vet examined a growing number of adverse reactions, prompting the withdrawal. Wyeth then launched a secret investigation into the vet; raised conflict-of-interest charges against her at the FDA; and implicitly threatened FDA officials that further action would be pursued if the vet was allowed to remain in place. Among those involved in a failed effort to allow ProHeart 6 b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1543924 Wed, 25 Jun 2008 21:35:47 +0100 1543924 http://www.medworm.com/index.php?rid=1522434&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F313428042%2F Under pressure from Washington, Merck, Johnson & Johnson and Pfizer are agreeing a six-month moratorium on advertising new drugs to consumers and will limit how docs are used in their ads, Advertising Age reports. The changes were unveiled today in letters they sent the House Energy and Commerce Committee responding to a request from committee the chairman John Dingell, a Michigan Democrat and, Bart Stupak, another Michigan Democrat who heads the committee’s oversight and investigations panel, according to the mag. Dingell and Stupak had wanted a two-year voluntary moratorium on advertising new meds to consumers, and possibly even longer in the case of drugs for which not all studies have been completed, Ad Age ads. The lawmakers also asked the drugmakers to limit the use of d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1522434 Tue, 17 Jun 2008 01:06:52 +0100 1522434 http://www.medworm.com/index.php?rid=1458859&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F294545250%2F That’s what two Congressmen are asking the ceo’s at Pfizer, Schering-Plough, Merck and Johnson & Johnson. John Dingell and Bart Stupak, Michigan Democrats who run the House Energy and Commerce Committee, also sent a letter to PhRMA’s Billy Tauzin asking if the trade group will update its guidelines. The move comes less than two weeks after the House Oversight and Investigations Subcommittee held a hearing on DTC advertising, which focused specifically on the infamous Lipitor ads featuring Robert Jarvik, as well as ads for Vytorin and J&J’s Procrit. During the hearing, execs from the drugmakers failed to promise Dingell they would implement changes to their advertising practices, citing a lack of authority. But they did invoke PhRMA guidelines, although Din... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1458859 Tue, 20 May 2008 21:03:32 +0100 1458859 http://www.medworm.com/index.php?rid=1454774&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F294238269%2F Bart Stupak says yes. The Michigan Democrat, who heads the House subcommittee that has been probing the agency for all sorts of reasons, wrote a letter last week to FDA commish Andy von Eschenbach to ask whether he would support efforts to provide subpoena power. The move comes after recent house committee testimony from Janet Woodcock, who runs the drug review branch, and Deborah Autor, who heads the agency’s Office of Compliance. Stupak, who would like to add subpoena power to the drug importation bill pending in the House, made a point of asking both officials whether subpoena power would be helpful. Their answers? Yes. As Stupak notes, the FDA does not have authority to demand some documents from drug and device makers without help from the Justice Department. Congress, meanwhile... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1454774 Tue, 20 May 2008 12:38:10 +0100 1454774 http://www.medworm.com/index.php?rid=1429314&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286061159%2F Yes, we are trying something new today. With the enormous interest in DTC ads, in general, and the controversies surrounding the Lipitor and Vytorin advertising, in particular, we thought you would enjoy watching the hearing as it takes place. Not only that - special just for you - we are including another feature that allows you to write some comments as the events unfold. For instance, if Deepak Khanna, senior vp of the Merck/Schering-Plough joint venture says something incredible, you can chime in. Sounds like fun, yes? Here’s the witness list. It’s over now - hope you enjoyed it. We’ll try it again some time. The hearing is now over, and our live stream has ended. We’ll post archived video when it becomes available. This is the live recap as the hearing was go... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1429314 Thu, 08 May 2008 16:26:27 +0100 1429314 http://www.medworm.com/index.php?rid=1413593&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281682816%2F Want to know the full story behind those famous Bob Jarvik ads for Lipitor? How about the rationale for heavily promoting Vytorin? Then tune in next Thursday May 8 to the House Energy and Commerce Committee hearing on direct-to-consumer advertising. It promises to be a good show. The subcommittee on Oversight and Investigations is chaired by Bart Stupak, a Michigan Democrat and fierce industry critic who, you may recall, launched the probe of DTC ads and, more recently, called for FDA commish Andy von Eschenbach to resign. Here’s a Stupak quote: drugmakers “should know that they will be held accountable for the representations made in their ads.” Who will be there? Folks from Pfizer, Merck, Schering-Plough and Johnson & Johnson, according to Bob Ehrlich of DTC Perspecti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1413593 Thu, 01 May 2008 21:18:46 +0100 1413593 http://www.medworm.com/index.php?rid=1391295&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275595515%2F Members of a House Energy and Commerce Committee subcommittee chastised FDA commish Andy von Eschenbach today for not doing more inspections of foreign drug makers in the wake of the Heparin scandal and problems with numerous other products, the Associated Press reports. “Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people,” thundered Bart Stupak, a Democrate from Michigan, who chairs the Subcommittee on Oversight and Investigations. “If we don’t make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.” For his part, Andy told the lawmakers that he has asked the administration for more money to condu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391295 Tue, 22 Apr 2008 18:54:13 +0100 1391295 http://www.medworm.com/index.php?rid=1354206&cid=t_126582_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=1331531&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258980059%2F And Andy blames it on too many responsibilities and not enough funding. In a speech yesterday, von Eschenbach worries that the FDA “may fail in its mission to protect and promote the health of every American. Peril exists. (The agency must be) stronger, bigger and better” to continue as “the world’s gold standard as a regulatory agency,” according to Bloomberg News. Nonetheless, Andy continued, the FDA is focused on “how to manage and get out of this crisis.” And yet, he proclaimed, “the prognosis is excellent.” You may recall that an outside panel last year issued a report saying Americans are in danger because the FDA lacks the funding to keep pace with science. The agency’s budget is more than $2 billion annually and The White... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1331531 Thu, 27 Mar 2008 13:33:02 +0100 1331531 http://www.medworm.com/index.php?rid=1245270&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F238209806%2F The Democrat from Michigan, who chairs the House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations is busier than ever. He’s probing the FDA’s handling of Baxter’s Heparin, the blood thinner linked to hundreds of patient reactions and four deaths; TV ads for Pfizer’s Lipitor; the release of Vytorin clinical-trial data by Schering-Plough and Merck; the marketing of anemia drugs sold by Amgen and Johnson & Johnson; and the review of clinical trial data for Sanofi-Aventis’ Ketek antibiotic. The common wisdom is that politicians are genetically inclined to beat up on the FDA and pharma, especially Democrats who control Congress and when an election year is under way. But there is more to it than that. In 2000, Stupak’s 17-... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1245270 Wed, 20 Feb 2008 14:58:04 +0100 1245270 http://www.medworm.com/index.php?rid=1236367&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235806731%2F In his weekly note to FDA employees this afternoon, FDA Commish Andy von Eschenbach writes agency staffers with an update on the Heparin affair - you know, the Baxter blood thinner linked to 350 side effects and four deaths. The active ingredient is made in a plant in China, which the FDA never inspected. Given the barrage of criticism aimed at the agency, Andy tries to lift everyone’s spirits and assure them that he is ‘championing’ their cause. This was penned, by the way, just one day after Congressman Bart Stupak called for him to resign. From: Commissioner’s Comments To: FDA-Wide Sent: Fri Feb 15 16:25:02 2008 Subject: COMMISSIONER’S COMMENTS: The Challenge of Protecting Patients and Consumers Early this week, our agency announced that Baxter Healthcare C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1236367 Fri, 15 Feb 2008 23:03:34 +0100 1236367 http://www.medworm.com/index.php?rid=1234812&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235532285%2F Bart Stupak, who chairs the House subcommittee on Oversight & Investigations (pictured left), has had it with Andy von Eschenbach. In the wake of probes into the Ketek antibiotic and a failure to inspect facilities connected to the side effects and deaths linked to the Heparin blood thinner, the Democrat from Michigan wants Andy’s head. And so he believes the silver-tongued FDA leader (pictured right) ought to step down because “it’s just a total lack of leadership,” he tells the Associated Press. Stupak, who has railed against the FDA over safety issues involving various drugs over the years, goes on to say that he’s lost confidence in Andy and other top FDA officials over the handling of inspections and oversight, in general. An FDA spokeswoman tells th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1234812 Fri, 15 Feb 2008 12:38:55 +0100 1234812 http://www.medworm.com/index.php?rid=1156041&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F217811422%2F As part of its investigation into why Merck and Schering-Plough held onto the Vytorin trial data for two years and briefly changed the primary endpoint before the disappointing results were finally released this week, the House Subcommittee on Oversight and Investigations now plans to also look at the possibility that any of the drugmakers’ execs engaged in insider trading. A subcommittee spokesman tells us that letters are due to be sent to Merck and Schering-Plough today or tomorrow, following comments made this morning on CBS’s Early Show by subcommittee chair Bart Stupak, a Democrat from Michigan. “There’s certainly major misrepresentations not only to the effectiveness of the drug, but manipulating of the scientific data to further promote a product that isn&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1156041 Wed, 16 Jan 2008 19:47:40 +0100 1156041 http://www.medworm.com/index.php?rid=1149827&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216673771%2F Just because Merck and Schering-Plough finally released the dismal results of the Enhance trial for their Vytorin cholesterol med doesn’t mean John Dingell and Burt Stupak are done looking into the two-year delay in disclosing the data or the reasons for, briefly, changing the primary endpoint. Au contraire. The congressmen, who announced their probe the same day Merck and Schering-Plough backpedaled on the primary endpoint, released a statement this afternoon saying the House Energy and Commerce Committee are as energized as ever about learning the reasons the drugmakers behaved as they did. “Today’s announcement that the Enhance study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1149827 Mon, 14 Jan 2008 22:29:44 +0100 1149827 http://www.medworm.com/index.php?rid=1134001&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F212844334%2F In particular, the focus is on Robert Jarvik, premiere pitchman for Pfizer’s Lipitor. In a letter to Pfizer ceo Jeff Kindler, John Dingell, the Democrat from Michigan who chairs the Committee on Energy and Commerce, and Bart Stupak, also a Democrat from Michigan who chairs the Subcommittee on Oversight and Investigations, have decided to open an investigation into the use of celebrity endorsements in DTC ads. “We are concerned that consumers might be misled by Pfizer’s television ads for Lipitor starring Dr. Jarvik,” Dingell says in a statement. “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.” Says Stupak: “Dr. Jarvik’s appearance in the ads could influence consumers into tak... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1134001 Mon, 07 Jan 2008 22:35:13 +0100 1134001 http://www.medworm.com/index.php?rid=1021322&cid=t_126582_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2007%2F11%2Famericans-may-be-over-vaccinated-is.html Last week, an article published in The New England Journal of Medicine written by Oregon Health & Science University researchers suggested that Americans may be over-vaccinating ourselves. Specifically, the authors found that antibodies from some vaccines actually stay around in the bloodstream for much longer than previously thought, which means that the current schedules for some vaccinations may be overkill. The study found that protection from conditions such as measles, mumps and rubella following exposure to the diseases were, in most cases, maintained for life. For more background, see The Wall Street Journal health blog posting here."If we can continue to improve our vaccines, someday we might be able to give one shot and give lifelong immunity," said Mr. Slifka, associate professo... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1021322 Mon, 12 Nov 2007 15:30:00 +0100 1021322 http://www.medworm.com/index.php?rid=797220&cid=t_126582_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F143793588%2F Not long ago, stents were a hot business. Lately, though, the little devices are causing Johnson & Johnson big trouble. Studies released earlier this year questioned their safety due to blood clots, causing sales to decline sharply. In fact, stent problems were cited as a key reason for J&J’s recent decision to eliminate more than 4,300 jobs. Now, the House Energy & Commerce Committee has sent letters to J&J and the FDA wanting to know why sales of its Cypher stent were allowed to continue even after agency inspections in 2004 turned up numerous manufacturing problems at J&J’s Cordis unit. In their letters, committee chair John Dingell and Bart Stupak, who chairs the subcommittee on oversight and investigations, ask for e-mails, meeting notes, records o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=797220 Mon, 13 Aug 2007 21:31:46 +0100 797220 http://www.medworm.com/index.php?rid=687106&cid=t_126582_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2007%2F06%2Fforbes-and-genetics-part-4.html This study was published before the Forbes article and they easily could have mentioned all of these genes in one part. But they did not. Why? I think it has to do with the ties to deCODE. But that's just the conspiracy theorist in me.I have an issue with this quote-"It is the strongest diabetes-promoting gene yet discovered."Wow!! In what population? There are other genes in populations not northern European that have higher risk. This statement is almost false!!! Frankly I think we should take a point away from Forbes for this. But I won't.Sherpa 4 .... Forbes 3The Sherpa Says: I love how the media mixes true things into their agenda. It is a sneaky way to appear factual and credible. If they would have to submit these things to peer review before publishing, then we would have a differe... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=687106 Mon, 18 Jun 2007 13:24:00 +0100 687106