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 'baxter'. Sat, 03 Sep 2011 02:09:23 +0100 http://www.medworm.com/index.php?rid=5182323&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMmVEzuXRy0%2F Top of the morning to you. And yet another shiny day is unfolding over the Pharmalot corporate campus, where the short people and the official mascots appear to be snoozing indefinitely. This rare treat gives us more time this morning to brew those mandatory cups of stimulation and poke around for interesting items. So here they are. Meanwhile, we will get back to conducting our own version of R&D. So keep us in mind if you hear something interesting. Have a great day… Sanofi Strikes Deal To Make Generic Lipitor (Reuters) FDA And Drugmakers Agree On 6 Percent PDUFA Fee Hike (Wall Street Journal) XOMA CEO Resigns (Reuters) Baxter Sues Teva To Enforce Propofol Liability (Bloomberg News) Death Rate Rises In Clinical Trials In India (The Tribune) Contract Pharmaceuticals To Lay Off ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182323 Thu, 01 Sep 2011 12:08:48 +0100 5182323 http://www.medworm.com/index.php?rid=5181703&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F08%2Fjama-article-begs-key-questions-about.html There was a recent reminder of the case of the tainted heparin, which begged more questions than it answered.  (A case summary is appended to the end of this post, and nearly all our posts are here.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.   Three years later, how the heparin was adulterated, and who was responsible are still unknown. JAMA just published a major news article (Kuehn BM. As production goes global, drug supply faces greater risks to safety, quality.  JAMA 2011; 306: 811-813.  Link here.) This, in turn, was based on a five page case study of the heparin incident in a report by the Pew Health G... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5181703 Tue, 30 Aug 2011 19:53:00 +0100 5181703 http://www.medworm.com/index.php?rid=5159834&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOa5-_YVQ_fM%2F And so another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes shuttling one of our short people off to an institution of higher learning, catching up on some reading and then bracing for a hurricane. Big fun, as they say. And what about you? Will you be boarding windows? Evacuating the homestead? For those of you in other locales, perhaps this slow time of the year is ripe for a pleasant drive or an outdoor event. Whatever you do, enjoy and be safe. See you soon… UK Probes How Medications Were Switched (BBC) Cipla Seeks Partners, Not Divestitures (Pharma Times) Shire Wins Approval Of Anti-Swelling Drug (Bloomberg News) Surgical Mesh Devices Should Be Banned: Watchdog Group (Star-Ledger of NJ) FDA Ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159834 Fri, 26 Aug 2011 12:09:55 +0100 5159834 http://www.medworm.com/index.php?rid=5051234&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSuPzOqs71VA%2F How is this for grave conditions in the workplace? A Baxter Healthcare unit was fined $371,250 for “deliberate and willful” safety violations that resulted in the death of a technician and serious injury to two others, according to the California Division of Occupational Safety and Health. All together, there were four willful citations issued, indicating intentional violation or knowledge of a violation. “We will not tolerate employers who intentionally sacrifice the safety of their workers,” California Department of Industrial Relations acting director Christine Baker says in a statement. “Our goal is to prevent these needless tragedies and ensure employers live up to their responsibility of protecting their workers.” Here’s what happened: On January 21, a 3... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051234 Fri, 22 Jul 2011 13:13:21 +0100 5051234 http://www.medworm.com/index.php?rid=4934029&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F06%2Ffirst-contaminated-heparin-case-verdict.html In February, 2008, we first posted about the case of the deadly adulterated heparin.  (A case summary is appended to the end of this post, and nearly all our posts are here.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.  It is also of fundamental importance because it may be about how this failure to fulfill core mission was not due to accident, or even simple incompetence, but due to putting financial goals ahead of patient safety.  The latest event in the very slowly unfolding aftermath of this case was the first verdict against the sellers of the heparin in a civil trial in a US court room.  As reported by the Chicago Tribune,A Cook Coun... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4934029 Mon, 13 Jun 2011 19:26:00 +0100 4934029 http://www.medworm.com/index.php?rid=4921751&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSl0FiwryeeY%2F An Illinois jury has awarded $625,000 to the estate of a man who was given a dosage of the heparin blood thinner that contained a contaminated ingredient, The Chicago Tribune writes. The verdict is the first against Baxter International and its supplier, Scientific Protein Laboratories, among hundreds of such lawsuits. Three years ago, the FDA determined the heparin contained fake ingredients from China. The heparin scandal, you may recall, focused a harsh light on the pharmaceutical supply chain, notably poorly supervised manufacturing in China and the inability of the FDA to perform sufficient oversight. The episode led to Congressional hearings and significant pressure on the agency to upgrade its supervision (see here, here and here). Attorneys for the estate of Steven Johansen of Oak ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921751 Fri, 10 Jun 2011 12:41:17 +0100 4921751 http://www.medworm.com/index.php?rid=4658413&cid=t_109117_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F30%2Fgrowing-up-bipolar%2F “Were you bipolar growing up?” a magazine editor asked me the other day. “I don’t know,” I said. “Do you think you were misdiagnosed back then as depressed?” “I don’t know,” I said. I wasn’t annoyed. I wasn’t rushed. I just really don’t know. I can clearly say that something was wrong with me, but I’m very careful to throw the “bipolar” word around when it pertains to kids given all the debate today on the topic. Friends of mine rant on another friend for medicating their daughter for bipolar disorder, who, according to the friends’ eyes, is perfectly fine. And then I hear the sadness and utter frustration of another friend whose bipolar daughter was just expelled from school. While I tend to be pretty conservative about meds myself (you’d never guess t... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4658413 Wed, 30 Mar 2011 18:30:32 +0100 4658413 http://www.medworm.com/index.php?rid=4517139&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F02%2Fthree-years-later-congressional.html Slightly more than three years ago, we first posted about the case of the deadly adulterated heparin.  (A case summary is appended to the end of this post, and nearly all our posts are here.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.   Three years later, how the heparin was adulterated, and who was responsible are still unknown. So now, it seems, there will actually be an official investigation.  As reported by Alicia Mundy in the Wall Street Journal,The House Energy and Commerce Committee is conducting a formal investigation into the contaminated-heparin crisis of 2008, saying it wants regulators to figure out who was responsible f... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4517139 Thu, 24 Feb 2011 22:41:00 +0100 4517139 http://www.medworm.com/index.php?rid=4450520&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkraFUdPQ2ig%2F Two weeks ago, Baxter Healthcare ceo Bob Parkinson disclosed to analysts that he received a warning letter from the FDA concerning problems at two plants in Puerto Rico. This is an embarassment and then some for Baxter, which was at the center of the contaminated Heparin scandal nearly three years ago that led to deaths and intense scrutiny of FDA oversight (back story). And so Parkinson made a point of mentioning the January 20 letter since it had not yet been disclosed publicly. Not surprisingly, he chose not to dwell on the contents, but did acknowledge the agency took issue with the way Baxter investigated unspecified “issues,” conveyed post-marketing reports and other “relevant information.” However, he stressed there were “no reported patient adverse eve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450520 Tue, 08 Feb 2011 15:23:22 +0100 4450520 http://www.medworm.com/index.php?rid=4428968&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F02%2Ffda-to-scientific-protein-laboratories.html Per Ed Silverman on the Pharmalot blog, we hear of new concerns about a company in the supply chain that ended up with adulterated heparin and dead patients.  Before summarizing what the blog reported, let me summarize the case again.Case Summary- We have posted several times, recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting in 2008, hundreds of such reactions, and now over 80 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was sold by Baxter International.- We then learned that although the heparin carried the Baxter label, it was no... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4428968 Wed, 02 Feb 2011 17:04:00 +0100 4428968 http://www.medworm.com/index.php?rid=4424441&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrMRhvr_EIp8%2F One of the companies at the center of the Heparin scandal nearly three years ago just can’t seem to get it right. Last fall, the FDA sent an inspection letter to Scientific Protein Laboratories because the supplier of active pharmaceutical ingredients received info that additional lots were contaminated in October 2008 - months after the scandal broke - but failed to adequately investigate for a year. Now, the FDA has issued a January 20 warning letter in which SPL was upbraided for failing to consider widening its internal investigation into contamination into other lots for another eight months. This is serious; the blood thinner, you may recall, was linked to more than 80 deaths and hundreds of serious reactions in patients in late 2007 and early 2008. In the spring of 2008, an FD... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424441 Tue, 01 Feb 2011 17:24:42 +0100 4424441 http://www.medworm.com/index.php?rid=4394746&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYECv4Iz6fOk%2F Rise and shine, everyone. Another day is on the way. And here on the Pharmalot corporate campus, we are, once again, hustling those short people off to their school houses. Wish us luck. Meanwhile, we are also trying to brew a much-needed cup of stimulation - our flavor today is Southern Pecan - and scour the news of the world. And so here are a few tidbits. Hope your day goes well and drop us a line about anything interesting… J&J Sales Hurt By Product Recalls (Reuters) Amgen Buys A Cancer Drugmaker: Are More Deals Coming? (Bloomberg News) Wolters Kluwer Forms Joint Venture With China’s Medicom (Philadelphia Inquirer) Savient Pharma Hires Lilly Oncology Exec As CEO (Reuters) Cost Of Treating Heart Disease Will Triple By 2030 (Bloomberg News) Clinical Data And Its Antidepr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394746 Tue, 25 Jan 2011 13:02:18 +0100 4394746 http://www.medworm.com/index.php?rid=4233423&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_l5xPun2CM0%2F If you thought that bundle of classified cables oozing from WikiLeaks was confined to diplomatic foibles and heads of state, but had little to offer about the pharmaceutical world, well, guess what? One cable lists overseas pharma facilities that are considered vital to US national security. How so? Losing these facilities “could critically impact the public health, economic security, and/or national and homeland security of the United States,” according to the Feb. 18, 2009, cable from the US Secretary of State to all diplomatic posts overseas (read it here). The list was part of an effort to catalog critical infrastructure and key resources as part of the National Infrastructure Protection Plan. The cable mentions plants that produce insulin and vaccines to combat small pox, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233423 Mon, 06 Dec 2010 13:07:28 +0100 4233423 http://www.medworm.com/index.php?rid=4225186&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Funreasonably-dangerous-heparin.html It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic.Case Summary Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Bax... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4225186 Thu, 02 Dec 2010 19:34:00 +0100 4225186 http://www.medworm.com/index.php?rid=4183543&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9LyvHMKYP70%2F Good morning, everyone. And welcome to another busy day, although already we are daydreaming about the weekend. And why not? For our part, we envision getting exercise in the form of raking still more leaves; frolicking with the short people and catching up on sundry chores. What about you? Time for a movie or a good book? Tossing a football? Maybe stopping to appreciate a special someone? Whatever you fancy, have a great time. Meanwhile, here are some tidbits. See you soon… EMA Adopts New Guidelines On Biosimilar Antibodies (Reuters) Pfizer And Bristol-Myers Halt Study Of Bloodthinner (Bloomberg News) FDA Approves Amgen Bone Med For Some Cancers (Reuters) Merck Wins Reversal On ‘Unenforceable’ Patent Ruling (The American Lawyer) Court Says Baxter’s Heparin Was &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183543 Fri, 19 Nov 2010 12:54:35 +0100 4183543 http://www.medworm.com/index.php?rid=4073991&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Fmore-contaminated-heparin-but-who-leads.html We have posted multiple times over the last two years about the deadly contaminated heparin from China. (See the case summary and link at the end of this post.) One of the key players in this case was a company called Scientific Protein Laboratories (SPL). The company that sold the heparin in the US under its logo, Baxter International, had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from Scientific Protein Laboratories, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4073991 Fri, 15 Oct 2010 20:56:00 +0100 4073991 http://www.medworm.com/index.php?rid=3946690&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhQAvUYTu_zk%2F Hello, everyone, nice to see you again. A sunny day is dawning here on the Pharmalot corporate campus, where the short people are off to the schoolhouse for another year of adventure and, hopefully, a little learning. While we ponder the possibilities, please join us for another cup of stimulation and a quick scan of the news of the world. Hope your day goes well… Glaxo Hires Goldman Sachs Banker as CFO (Reuters) Business Confidence Is Higher In Pharma Sector (PharmaTimes) Biovail And Valeant Merger To Increase Layoffs (The Globe & Mail) Teva & Baxter Must Pay $365M To Man Infected With Hepatitis C (Ha’aretz) Clinical Trials Initiated In South Korea Rose 150% Since 2006 (OutsourcingPharma) Shanghai Pharma Plans $1.2B IPO (Reuters) Glaxo And Lonza Sign Development Deal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946690 Wed, 08 Sep 2010 12:00:05 +0100 3946690 http://www.medworm.com/index.php?rid=3921072&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4G-9Di_UofA%2F File this under three strikes and you’re out: Baxter Healthcare was dinged by the FDA for circulating a brochure for its Aralast NP emphysema treatment that contains misleading efficacy claims. As many of you know, this sort of overstatement is not all that unusual, but in Baxter’s case, well, the FDA has about had it. In its Aug. 3, warning letter, the agency points out that Baxter is a corporate recidivist. “We are very concerned by your continued violative promotion of your products,” the agency writes. “Baxter was cited for similar violations (overstatement of efficacy and unsubstantiated claims of superiority) in an April 14, 2009, Warning Letter and a July 7, 2008, Untitled Letter from OCBQ (the Office of Compliance and Biologics Quality).” And so... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921072 Tue, 31 Aug 2010 19:28:36 +0100 3921072 http://www.medworm.com/index.php?rid=3876592&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2Fproprietary-information-confidentiality.html The case of the deadly contaminated heparin sold by Baxter International has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Our most recent post, here, noted that an investigation into the contamination of the active pharmaceutical ingredient (API - actually the heparin itself) in China failed to produce any results, apparently because the Chinese government did not see fit to pursue it.  (Note that a brief summary of the whole case is at the end of this post.)Now a new story in the Wall Street Journal by Alicia Mundy explains even more about why we do not... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3876592 Tue, 17 Aug 2010 20:59:00 +0100 3876592 http://www.medworm.com/index.php?rid=3845282&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4xi4_YanGhk%2F As promised, the US Justice Department - along with the US Securities and Exchange Commission - is paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). In recent months, at least five big drugmakers have received letters as the federal government seeks to uncover any violations of the Foreign Corrupt Practices Act, which forbids US companies from bribing foreign government officials. Among those that have been contacted in recent months concerning their activities are AstraZeneca, Bristol-Myers Squibb, Baxter, Eli Lilly and Merck (see page 26 here). An AstraZeneca spokesman says the drugmaker is cooperating. A Lilly spokesman notes the drugmaker, which was the subject of a 2003 probe of its Polish subsidiaries, is also cooperatin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845282 Mon, 09 Aug 2010 13:12:04 +0100 3845282 http://www.medworm.com/index.php?rid=3784497&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6HqJvyNr744%2F After five-plus years of anticipation, the FDA has approved a generic version of Lovenox, a $4 billion blood thinner sold by Sanofi-Aventis. The approval comes after a three-way race between Momenta Pharmaceutical, which received the agency endorsement, and two others - Amphastar Pharmaceuticals and Teva Pharmaceutical. There is no word on approval for the rival meds (here is the FDA statement). In a word, this is really about biologics and the implications are enormous. “Lovenox is technically not a biologic, yet functionally and effectively it is,” writes Sanford Bernstein analyst Tim Anderson in an investor note. “Many in industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully substitutable - which it just has - ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3784497 Fri, 23 Jul 2010 20:53:22 +0100 3784497 http://www.medworm.com/index.php?rid=3784215&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fmore-about-what-we-dont-know-about.html We last blogged about the case of Baxter International's adulterated heparin here.  (For a more detailed summary of the case, look here.)In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3784215 Fri, 23 Jul 2010 15:13:00 +0100 3784215 http://www.medworm.com/index.php?rid=3767034&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fprosecuting-doctors-for-importing-iuds.html Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared in the Providence Journal, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved.The Unapproved IUDsHere are the main points. The issue that caused so much local controversy was the use of unapproved IUDs:Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3767034 Mon, 19 Jul 2010 16:10:00 +0100 3767034 http://www.medworm.com/index.php?rid=3699706&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAM2Nw1RqLtc%2F Rejecting an appeal, the Federal Competition Commission voted 4 to 1 to fine the companies $11.6 million for conspiring to raise prices of meds sold to a social-services agency, Instituto Mexicano del Seguro Social, according to this statement. The decision comes shortly after the antitrust regulator indictated new investigations may be launched into drugmakers for scheming to inflate prices (background). According to the CFC, the drugmakers engaged in monopolistic practices during public bidding organzied by the agency and, in doing so, eliminated competition, which forced the IMSS, as its known, to pay artificially high prices. Those fined include Eli Lilly, Laboratorios Cryopharma, Probiomed, Fresenius Kabi Mexico, Baxter and Laboratorios Pisa. The meds involved were insulin and injecta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699706 Fri, 25 Jun 2010 12:03:59 +0100 3699706 http://www.medworm.com/index.php?rid=3656809&cid=t_109117_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbuzzy-pain-relief-for-kids%2F2010.06.13 Here’s Buzzy, a reusable pain relief device developed by a pediatrician. It works based on the gate control theory of pain: Buzzy is a newly developed reusable pain relief device that children can bring to the doctor’s office with them to help dull the pain of shots! As the brainchild of Pediatrician Amy Baxter, Buzzy rapidly reduces pain when pressed onto the skin. Buzzy is especially helpful for children who receive shots often, like those suffering from diabetes. Buzzy can also be used for the small things, like taking splinters out! Not only is Buzzy a kid-favorite, but it’s safe, effective immediately on contact, FDA compliant, and environmentally friendly, too. *This blog post was originally published at ScienceRoll* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3656809 Sun, 13 Jun 2010 12:00:09 +0100 3656809 http://www.medworm.com/index.php?rid=3629869&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtWSO5WagTa4%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something that’s become a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Alnylam Pharmaceuticals hired Laurence Reid as senior vice president and chief business officer. He was previously at Ensemble Discovery, where was also chief business officer, and founded two start-up companies in stem ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3629869 Fri, 04 Jun 2010 11:22:15 +0100 3629869 http://www.medworm.com/index.php?rid=3599738&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOgrZm0fTE7A%2F Rise and shine. Another day awaits. And who knows what lies ahead? Meetings? Deadlines? Unexpected tidbits of information? We can relate. So grab a cup of stimulation - or perhaps, a bottle of water, since it will be rather sticky today in the greater Pharmalot metropolitan region - and dive in. As always, here are some items to ease the process. Have a great day everyone and stay in touch… UK’s NICE Won’t Cover Bayer Liver Cancer Drug (Bloomberg News) AMRI Cuts US Workforce 10% And Shifts Jobs To Asia (OutsourcingPharma) FTC Commish Remains Bullish On Ending Pay-To-Delay Deals (PharmaTimes) Dennis Quaid Sues Baxter Over Heparin Overdose (USA Today) Merck Will Not Raise Its Dividend (Associated Press) Sanofi-Aventis Will Reassign Global Media Ad Duties (MM&M) Photo t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599738 Wed, 26 May 2010 11:48:29 +0100 3599738 http://www.medworm.com/index.php?rid=3577622&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FN2Mz6xyOy2c%2F A panel investigating the World Health Organization’s response to last year’s swine flu outbreak wants to see confidential exchanges between the agency and drugmakers. The 29-member panel wants WHO records and correspondence from before and after the H1N1 strain was declared a pandemic in June, the Associated Press reports. “We will want to have access to certain confidential documents that may be in place here at WHO or elsewhere,” committee chair Harvey Fineberg, who is also president of the Institute of Medicine in Washington, told reporters in Geneva, adding that documents include “contractual or letters of understanding” between the WHO and drugmakers. Some agreements have been considered confidential, but so far all requests have been met. The pane... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577622 Wed, 19 May 2010 15:45:07 +0100 3577622 http://www.medworm.com/index.php?rid=3549567&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI_HEEGxSij0%2F Welcome to the working week. We hope your weekend was pleasant and gave you a chance to refresh. Now, of course, the routine resumes, which means those meetings and deadlines loom once again. To prepare, we have assembled a few interesting items to jumpstart what is, so far, a sunny day. Meanwhile, we will brew yet another cup of stimulation. Have a good one and do stay in touch… NiCox Painkiller Heads For FDA Panel Review (PharmaTimes) Sandoz Building In Denver Catches Fire (The Denver Post) Teva And Baxter To Fight $500M Damages In Propofol Case (Bloomberg News) Spain Should Encourage Docs To Prescribe Generics (PharmaTimes) Cipla Revenue Forecast Misses Target (Bloomberg News) Boehringer Ingelheim To Accelerate M&A In China (Global Times) Merck To Shift India Office To Mumbai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3549567 Mon, 10 May 2010 11:33:24 +0100 3549567 http://www.medworm.com/index.php?rid=3542871&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnFw0fdHNQ8E%2F Teva Parenteral Medicine and Baxter Healthcare Services were ordered to pay more than $5 million after a jury found the companies liable in the first civil trial stemming from Southern Nevada’s hepatitis C outbreak, The Las Vegas Review Journal reports. The jury decided the drugmakers, which sold the propofol sedative, failed to label vials with appropriate warnings and should not have provided large vials of the anesthetic to endoscopy centers. Henry Chanin, 62, and his wife filed suit after he received a colonoscopy in 2006 at a clinic during which he was infected with hepatitis C. The center is one of two Las Vegas clinics linked to an outbreak. The jury awarded $3.25 million to Henry Chanin and $1.85 million to Lorraine Chanin. During the three-week trial, Henry Chanin testified... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3542871 Fri, 07 May 2010 11:42:48 +0100 3542871 http://www.medworm.com/index.php?rid=3538045&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fmore-questions-no-answers-about-case-of.html In 2008, we started posting on how the "active pharmaceutical ingredient" of heparin made in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company. Ultimately, many patients were sickened, or died. A summary of our posts on the topic, in smaller type, is below.- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin relate... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3538045 Wed, 05 May 2010 20:25:00 +0100 3538045 http://www.medworm.com/index.php?rid=3530030&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSwQBILUNSpE%2F Mexico’s top antitrust regulator may launch new investigations into drugmakers for scheming to inflate prices. You may recall that, in February, the Federal Commission Competition fined Lilly and three others for taking turns placing winning bids in government tenders to buy insulin from 2003 to 2006, eliminating competition and ensuring artificially high prices (background and the FCC statement). “We’re continuing to look into doing more investigations,” Eduardo Perez Motta, head of Mexico’s Federal Competition Commission told the Reuters Latin American Investment Summit in Mexico City. “There could be more (fines). I can’t give more details about them, but there could be more.” The Mexican units of Baxter International and Fresenius Kabi we... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3530030 Tue, 04 May 2010 12:11:40 +0100 3530030 http://www.medworm.com/index.php?rid=3486996&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F04%2Fanother-echo-of-case-of-deadly-heparin.html In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below.Case Summary- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infus... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3486996 Mon, 19 Apr 2010 20:53:00 +0100 3486996 http://www.medworm.com/index.php?rid=3476080&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3pw0blnXNjE%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Baxter International hired Ludwig Hantson as corporate vice president and president, international. The move comes just two days after Hantson departed Novartis, where he headed the US pharmaceutical unit. A replacement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3476080 Fri, 16 Apr 2010 11:58:44 +0100 3476080 http://www.medworm.com/index.php?rid=3244048&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU_U7Ito0v0w%2F The research collaboration between Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency, according to FDA legal counsel Ralph Tyler, The Baltimore Sun writes. But Woodcock voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals, which raised the allegations last April, the paper reminds us. Both companies are developing a generic version of low molecular weight heparin, which is currently sold by Sanofi-Aventis as Lovenox. “We’ve determined that there’s no conflict here,” Tyler tells the paper, ad... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3244048 Fri, 05 Feb 2010 13:00:28 +0100 3244048 http://www.medworm.com/index.php?rid=3171855&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F01%2Fblog-post.html A small news item published by Bloomberg is a reminder of a serious case that was never resolved:Baxter International Inc., which recalled its blood thinner heparin amid reports of allergic reactions and deaths in 2008, faces at least 30 lawsuits in Chicago by injured people or their estates.As many as 300 product-liability complaints may be filed in the Illinois state court, plaintiffs’ attorney Allen Schwartz of Kralovec, Jambois & Schwartz said today in a phone interview. His law firm and two others are working to comply with a judge’s order last year to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based company. I have appended a summary of the case at the bottom of the post, with relevant Health Care Renewal links.   What is most ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3171855 Thu, 14 Jan 2010 15:41:00 +0100 3171855 http://www.medworm.com/index.php?rid=2737831&cid=t_109117_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fhit-deluge-part-i-need-and-opportunity There was a time --not too long ago, in fact-- when it seemed safe and reasonable to define health information technology narrowly: the acronym encompassed the management of health information and its secure exchange between patients, providers, and insurers. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=2737831 Thu, 27 Aug 2009 13:53:32 +0100 2737831 http://www.medworm.com/index.php?rid=2699587&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F08%2Fwho-investigated-case-of-deadly.html A year and a half ago, we posted quite a bit about the case of the deadly contaminated heparin. In retrospect, what is most amazing is how quickly this case fell off the radar screen.Summary of the Case of the Deadly Contaminated HeparinHere is a summary:- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.- We then learned that although the heparin carried the Baxter label,... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2699587 Thu, 13 Aug 2009 17:39:00 +0100 2699587 http://www.medworm.com/index.php?rid=2240797&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fharvard-medical-students-against.html An article by Duff Wilson in the New York Times this week provided a new look at the pervasiveness of financial relationships among academic medicine and health care corporations, and the beginnings of resistance to them.The Scope of the RelationshipsMany individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.The rules, though, do not require them to report specific amounts received for speaking or... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2240797 Fri, 06 Mar 2009 18:17:00 +0100 2240797 http://www.medworm.com/index.php?rid=2055762&cid=t_109117_87_f&fid=34825&url=http%3A%2F%2Fwww.wesleyjsmith.com%2Fblog%2F2008%2F12%2Fblog-post.html I have an extended piece in the Weekly Standard on the Montana judge declaring it a "fundamental right" do "die with dignity"--e.g. to poison oneself with prescribed drugs--which as I noted in an earlier SHS posting about this, may be the only time that an advocacy propaganda phrase was elevated in a court ruling to the status of a constitutional right.In the piece I point out that much of the decision is, essentially about metaphysical opinions and concepts. From the piece:A premise of McCarter's ruling is that people have the right to decide for themselves what constitutes "dignity" according to their personal beliefs. After quoting the authorities she relied on--which would be too long to reproduce here--I state:In essence, Judge McCarter ruled that the individual's right to act upon su... Secondhand Smoke blogs http://www.medworm.com/rss/comments.php?id=2055762 Sat, 20 Dec 2008 16:59:00 +0100 2055762 http://www.medworm.com/index.php?rid=1930403&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F440022434%2F In an essay that takes a top-down view of the agency and its myriad problems protecting the supply of pharmaceuticals, Gardiner Harris of The New York Times reviews the highlights - or lowlights - of the past year or so: the Heparin deaths, the Ranbaxy scandal and the withering criticism from Congress. And he notes some of the issues bedeviling the FDA as it struggles to cope with the growing role played by Chinese suppliers: antiquated FDA computer systems, an inability among FDA staff to decipher names of Chinese plants, difficult travel conditions for agency inspectors, and, of course, the debate over sufficient FDA funding. For instance, this year, 18.2 million shipments of food, devices, cosmetics and drugs are expected to enter more than 300 US ports, but the FDA had 454 investigator... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1930403 Sun, 02 Nov 2008 15:17:56 +0100 1930403 http://www.medworm.com/index.php?rid=1726576&cid=t_109117_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2561 The California Board of Pharmacy has shown that it is willing to get tough with pharmacies that may have exacerbated the impact of the heparin crisis. It has fined nearly 100 hospital pharmacies who did not properly adhere to Baxter’s heparin recall earlier this year. (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1726576 Fri, 22 Aug 2008 13:53:55 +0100 1726576 http://www.medworm.com/index.php?rid=1668707&cid=t_109117_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2431 This just in from the Chicago Tribune: only a small number of patient deaths connected to tainted heparin could conclusively be traced to material sold by Baxter.   How many other ticking pharma QC time bombs are out there, waiting to explode?  We’ll examine this issue next month from analytical, regulatory and quality systems angles. (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1668707 Wed, 30 Jul 2008 23:51:48 +0100 1668707 http://www.medworm.com/index.php?rid=1649306&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F343830430%2F Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Alle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1649306 Wed, 23 Jul 2008 19:06:15 +0100 1649306 http://www.medworm.com/index.php?rid=1594008&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F328825240%2F In striking the deal, the German company, which is one of the largest suppliers of dialysis services and products, gains control of one of the biggest makers of generic injectable drugs. APP, which is based in Illinois, is now the biggest supplier of the Heparin blood thinner heparin in the US, following the recall earlier by Baxter International in response to hundreds of cases of serious side effects. The acquisition gives Fresenius more than 100 patent-free products for hospital patients receiving cancer, intensive care and infection treatments as well as anesthetics. APP, by the way, is headed by Patrick Soon-Shiong (pictured above), who gained notoriety a couple of years ago with his other company, Abraxis BioSciences, which charged a very high price for a generic version of the Taxol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1594008 Mon, 07 Jul 2008 12:09:35 +0100 1594008 http://www.medworm.com/index.php?rid=1531156&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F06%2Foutsourced-to-death.html A while back, we posted frequently about the sudden toxicity of what used to be an apparently well understood drug. A summary of the story to date is below (in smaller type.):- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1531156 Thu, 19 Jun 2008 20:12:00 +0100 1531156 http://www.medworm.com/index.php?rid=1449574&cid=t_109117_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1811 OK, Rockville’s a long way from Miami…but the analytical detective work that FDA, MIT scientists and some companies did into potential root causes of heparin contamination makes a great whodunit.  C&EN, an outstanding publication, beat us to it by several months with this gem, published in late November. In case you missed it, here it is. There are [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1449574 Fri, 16 May 2008 18:07:44 +0100 1449574 http://www.medworm.com/index.php?rid=1426774&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F285330212%2F Do you remember what the Morning Mayor used to say? Every brand new day should be unwrapped like a precious gift. So go ahead, open yours. And after you do so, grab a cup of something refreshing and take a peek at these… Baxter Says Heparin Legal Costs Are Insignificant (The Chicago Tribune) Roche Targets Diabetes To Replace Cancer Sales (Bloomberg News) FDA Panel Rejects Wider Use of Cephalon Drug (Yahoo/Reuters) Teva Seeks Judgment On Nexium Patents (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426774 Wed, 07 May 2008 11:54:58 +0100 1426774 http://www.medworm.com/index.php?rid=1423663&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F284638695%2F This is the international version of the blame game. Last month, Chinese officials voiced doubt that a contaminant identified in Heparin caused 81 deaths and severe allergic reactions in hundreds of Americans, and suggested the problem could have occurred in the US. Now, they insist the Chinese-made blood thinner wasn’t to blame and accused Baxter International of obstructing an investigation. “Apart from the US and Germany, more than 10 other countries using heparin products containing the ‘heparin-like substance’ have not reported adverse reactions,” China’s Food and Drug Administration said in a statement, Reuters writes. The agency adds that reactions also occurred in some Heparin batches that didn’t contain the substance, hypersulfated chondro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1423663 Tue, 06 May 2008 13:19:20 +0100 1423663 http://www.medworm.com/index.php?rid=1413601&cid=t_109117_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1741 We all know that physicians must distance themselves from patients to keep from becoming too emotionally involved in each case.  Perhaps this applies to drug development and manufacturing as well, and industry profesionals may risk viewing adverse patient reactions as a mere statistic. Emotional connection to the patient is essential to preventing future quality control disasters like [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1413601 Thu, 01 May 2008 14:32:20 +0100 1413601 http://www.medworm.com/index.php?rid=1413423&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F05%2Fblaming-some-dude-for-contaminated.html It is time to update the story of the contaminated heparin. A summary of the story to date is below (in smaller type.):- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious s... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1413423 Thu, 01 May 2008 14:08:00 +0100 1413423 http://www.medworm.com/index.php?rid=1411847&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281084244%2F A House investigator charged that the FDA’s Office of Chief Counsel has undermined a congressional drug safety investigation, InsideHealthPolicy* reports. Energy and Commerce Committee investigator David Nelson told a bipartisan committee the probe was stymied because the FDA office denied investigators access to documents and personnel, the web site wrote. Committee investigators interviewed operational and field staff at FDA - who were involved in heparin inspections and scientific analyses - but not agency lawyers involved in policy decisions, according to InsideHealthPolicy. “We’ve not gotten interviews with the counselors that make many of these decisions or at least have veto authority over those decisions,” Nelson told the committee. Nelson also told the House panel that... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1411847 Thu, 01 May 2008 06:06:47 +0100 1411847 http://www.medworm.com/index.php?rid=1409760&cid=t_109117_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F281037867%2Fheparin_contamination_delibera.html We've been following the heparin contamination story for a while now. We first reported that Baxter had voluntarily recalled specific batches of the drug, then followed that up with the story of how the contaminated heparin was causing allergic reactions in dialysis patients and then reported on how the FDA had found what had contaminated the batches of heparin. Now we are sadden to report that the Baxter CEO Robert Parkinson stated in a written statement that was prepared for a congressional hearing into the contaminated heparin events that it appears that the contamination was deliberate."We're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result,&qu... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1409760 Wed, 30 Apr 2008 20:00:56 +0100 1409760 http://www.medworm.com/index.php?rid=1405464&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F279633688%2F Artificial blood products increased the risk of death by 30 percent and almost tripled the risk of heart attacks in 16 clinical trials, according to a study in the Journal of the American Medical Association. The researchers write that the FDA should have stopped the studies eight years ago, but meanwhile five trials are still under way and another is about to begin. Eight years ago, the FDA received data on individual studies showing increased risks that should have triggered suspension of testing until a large-scale analysis could be conducted, according to the researchers, who say the FDA should end the trials and Congress should review rules forcing the agency to keep info on new products confidential for competitive reasons. “One straightforward solution to these problems would ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1405464 Mon, 28 Apr 2008 21:07:54 +0100 1405464 http://www.medworm.com/index.php?rid=1391299&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275349371%2F Although the FDA increased inspections of foreign drug plants last year, the agency still checked only 11 percent of the sites that supply pharmaceutical ingredients to the US market. That’s what GAO health care director Marcia Crosse will tell the House Energy and Commerce Committee this morning at a hearing to discuss the FDA’s oversight of foreign manufacturing, according to Reuters. Concern about FDA oversight has risen since the finding of a contaminant in some batches of Heparin that were made with raw ingredients from China, where officials are now are voicing doubts that a contaminant identified in Heparin was the root cause of 81 deaths and severe allergic reactions in hundreds of Americans. “FDA’s plans represent a step forward in filling the large gaps ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391299 Tue, 22 Apr 2008 12:12:47 +0100 1391299 http://www.medworm.com/index.php?rid=1389196&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F274806921%2F And so the new cooperation pact with the US Health and Human Services and the FDA begins with a disagreement - Chinese officials are voicing doubts that a contaminant identified in Heparin was the root cause of 62 deaths and severe allergic reactions in hundreds of Americans, the Associated Press reports. The officials suggested at an embassy news conference that the problem with the drug could have occurred in the US and plan to visit a Baxter International plant in New Jersey to get a better picture of how the finished product is manufactured. “When you see it, then you believe it,” Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China, tells reporters. Heparin is derived from a mucus obtained f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1389196 Mon, 21 Apr 2008 16:19:22 +0100 1389196 http://www.medworm.com/index.php?rid=1376877&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F271388227%2F That’s what FDA commish Andy von Eschenbach said at Senate hearing, although he didn’t specify who added the contaminant and Baxter International maintains the contamination occurred before the blood thinner reached its supplier, Bloomberg News reports. Some samples of Baxter’s heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with a cheaper substance derived from animal cartilage. “It was apparently, we suspect, done by virtue of economic fraud,” von Eschenbach today told a Senate Appropriations subcommittee that oversees FDA spending. Of course, that’s another way of saying the contamination was done intentionally to make money. But after the hearing, Andy backpedaled and said his comments may have ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1376877 Wed, 16 Apr 2008 12:17:20 +0100 1376877 http://www.medworm.com/index.php?rid=1366895&cid=t_109117_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=1329046&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F03%2Fcontaminated-heparin-where-is-outrage.html We have posted frequently on the case of the contaminated heparin. A summary to date is below.We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1329046 Wed, 26 Mar 2008 14:49:00 +0100 1329046 http://www.medworm.com/index.php?rid=1325474&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257784986%2F Since the moment Heparin became a household word, Baxter International has been vulnerable. With nearly 800 serious adverse events and 19 deaths attributed to its blood thinner, the healthcare company has what attorneys call exposure. Of course, this should not come as a surprise in this litigous world. Still, the contaminated ingredient was introduced in China, where a Baxter supplier co-owns a plant. How much liability, then, does Baxter really face? We spoke with Eric Turkewitz, a personal injury attorney in New York and blogger, who has previously dueled with drugmakers, although he says he does not presently have any Heparin cases. This is an excerpt… Pharmalot: So how much trouble is Baxter in? Turkewitz: Enough. Assuming the reports are true. Baxter sold a counterfeit drug, wh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1325474 Tue, 25 Mar 2008 17:18:43 +0100 1325474 http://www.medworm.com/index.php?rid=1319316&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F03%2Fwho-was-responsible-for-purity-of.html We have posted several times, most recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn ob... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1319316 Fri, 21 Mar 2008 18:30:00 +0100 1319316 http://www.medworm.com/index.php?rid=1319574&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F255474274%2F In a reversal of its earlier stance, China’s drug safety agency is ordering local authorities to tighten controls on production of the Heparin blood-thinner that has been linked to nearly 800 allergic reactions and 19 deaths in the US, the Associated Press reports. The State FDA issued the order in a notice, which was seen on its web site, that requires Heparin producers to obtain raw chemicals used to make the drug from registered suppliers. And raw Heparin suppliers are now required to improve their management and tests on their products. Earlier, the agency had insisted that ensuring the quality of exported chemicals like Heparin was the responsibility of importers and importing countries. Heparin is derived from a mucous obtained from pig intestines (see photo) and other animal t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1319574 Fri, 21 Mar 2008 11:44:37 +0100 1319574 http://www.medworm.com/index.php?rid=1316820&cid=t_109117_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Fmedical-and-medication-errors-60-minutes-examines-dennis-quaids-twins-near-fatal-heparin-overdoses%2F This past Sunday, CBS’ “60 Minutes” program took a look at the unfortunate medication errors that nearly killed actor Dennis Quaid’s infant twins last November at Cedars-Sinai hospital in Los Angeles. The babies were in the hospital to receive intravenous antibiotics for a staph infection when they were accidentally injected with adult strength heparin, a blood thinner, which was 1000 times the dose they should have received. The overdose caused the children to have bruising and bleeding, but, fortunately, the mistake was recognized and the treatment was effective and they recovered with no apparent permanent effects. That wasn’t the outcome for three infants who died at Methodist hospital in Indianapolis last year who also received accidental overdoses of heparin (three ... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=1316820 Thu, 20 Mar 2008 18:09:34 +0100 1316820 http://www.medworm.com/index.php?rid=1314428&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254509498%2F There is a pattern shaping up - the FDA scrambles to hold a teleconference briefing on the latest twist in the Heparin investigation, and Congress raises the stakes by firing off more letters. Now, though, the House Energy and Commerce subcommittee on Oversight and Investigation has scheduled an April 28 hearing to find out more about how a contaminated batch of the Heparin blood thinner found its way from China to the US. Of course, we know one reason - the FDA failed to inspect the plant because of a mix-up over paperwork. Earlier today, the FDA acknowledged that a chemically altered substance called over-sulfated chondroitin sulfate is probably the contaminant that the FDA believes is linked to nearly 800 serious adverse events and 19 deaths. “FDA’s recent finding on the heparin-lik... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314428 Wed, 19 Mar 2008 20:55:00 +0100 1314428 http://www.medworm.com/index.php?rid=1314071&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F03%2Ffake-heparin-then-sick-and-dead.html We have posted several times, most recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions. All the heparin related to these events was made by Baxter International.We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1314071 Wed, 19 Mar 2008 19:18:00 +0100 1314071 http://www.medworm.com/index.php?rid=1314100&cid=t_109117_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F03%2Fbaxter-heparin-and-contaminant-is.html ........... over-sulfated chondroitin sulftate.I'll let Ed explain. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1314100 Wed, 19 Mar 2008 15:27:00 +0100 1314100 http://www.medworm.com/index.php?rid=1314435&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254278557%2F Scientists investigating a mystery contaminant in the blood thinner Heparin are closing in on what they believe is a counterfeit substance, most likely made in China from animal cartilage, that was chemically altered to act like the real drug, The New York Times reports. The FDA declined to confirm the info and a spokeswoman wouldn’t comment, the paper adds. But in interviews, Heparin experts in China and the US, including one researcher involved in the inquiry, say a chemically altered substance called over-sulfated chondroitin sulfate is probably the contaminant that the FDA believes is linked to nearly 800 serious adverse events and 19 deaths. Even so, researchers say they were not certain that the contaminant, constituting between 5 percent and 20 percent of the drug, is what is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314435 Wed, 19 Mar 2008 13:17:51 +0100 1314435 http://www.medworm.com/index.php?rid=1306093&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F252459258%2F The actor and his wife, you may recall, sued the Heparin maker late last year after their newborn twins were inadvertently given massive doses of the blood thinner at a Los Angeles hospital. The lawsuit seeks more than $50,000 in damages and claims Baxter Healthcare was negligent in packaging different doses of the product in similar vials with blue backgrounds, and also claims Baxter should have recalled large-dose vials after overdoses killed three children at an Indianapolis hospital last year. Baxter, of course, is also at the center of a scandal over contaminated Heparin. And so tonight at 7 pm EST, Quaid talks to 60 Minutes about an episode he describes as life-and-death in hopes of drawing attention to the problem of medical errors. “After these three kids died in Indiana, the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1306093 Sun, 16 Mar 2008 14:15:01 +0100 1306093 http://www.medworm.com/index.php?rid=1305852&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F252165349%2F That’s the latest plan by the agency, which is grappling with a controversy over contaminated batches of the widely used blood thinner. The version sold by Baxter International, you may recall, has been linked to nearly 800 reports of serious adverse events and 19 deaths in recent weeks and the problem has been traced to a plant in China, which the FDA failed to inspect until the scandal broke. To cope, the FDA is now implementing new import restrictions on raw Heparin, according to Janet Woodcock, who heads the agency’s drug review division. All supplies will be tested and, if necessary, blocked from entering the US. And to ensure the policy is adopted, she says bulletins are being issued to all FDA inspectors. If drugmakers and their suppliers don’t test raw heparin an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1305852 Sat, 15 Mar 2008 22:51:44 +0100 1305852 http://www.medworm.com/index.php?rid=1297932&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250340633%2F Germany’s medical regulator has asked all companies selling the Heparin blood thinner heparin in Germany to test all batches of their product for signs of contamination, The Wall Street Journal reports. Germany’s Federal Institute for Drugs and Medical Devices, known as BFARM, asked 10 manufacturers to conduct additional tests and expects results soon, perhaps by next week, Ulrich Hagemann, a pharmaceutical safety official at the agency, tells the paper, although he couldn’t name the companies for legal reasons, but said all are German. BFARM’s move follows last week’s recall in Germany of Heparin made by Rotexmedica GmbH, a unit of the French company Groupe Panpharma. The product was recalled after reports that some patients suffered allergic reactions. In th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297932 Wed, 12 Mar 2008 20:46:40 +0100 1297932 http://www.medworm.com/index.php?rid=1291150&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F248958093%2F Amid the ongoing scandal over contaminated Heparin came an interesting admission last week. You may recall the FDA failed to inspect a Chinese plant that supplied the key ingredient to Baxter International, which has recalled its supplies of Heparin, a blood thinner that was linked to hundreds of serious adverse events and 19 deaths. The FDA has since inspected the plant and found numerous problems. As it turns out, Baxter conducted its own inspection of the China plant last fall, The New York Times reported. “A few of our observations touched on the same areas as FDA inspectional findings,” Ray Godlewski, vp for quality at Baxter’s medication delivery business, told the paper. But he refused to be more specific because of a confidentiality agreement with Scientific Protein, the Tim... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1291150 Mon, 10 Mar 2008 16:27:53 +0100 1291150 http://www.medworm.com/index.php?rid=1287937&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247703118%2F Big drugmakers are ponying up over the AWP, or average wholesale price scandal, according to a statement by attorneys who filed the case. For those unfamiliar, the stated AWP is used to set the price paid by consumers making Medicare Part B co-payments, as well as Medicare, insurers and other third-party payors that shell out for a drug. The lawsuit charged that consumers and third-party payors paid more than they should have because the drugmakers used false AWP reporting. The issue has embroiled the entire industry. The latest settlement involves Abbott Labs, Amgen, Sanofi-Aventis, Baxter Healthcare, Bayer, Dey, Fujisawa, Pfizer’s Pharmacia unit, Watson Pharmaceuticals, Gensia Sicor Pharmaceuticals and ZLB Behring. And the drugs covered in the settlement include Aranesp, Epogen, Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1287937 Sat, 08 Mar 2008 01:56:34 +0100 1287937 http://www.medworm.com/index.php?rid=1286510&cid=t_109117_137_f&fid=36083&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FIAmAnAlzheimersCaregiver%2F%7E3%2F247573822%2Fbaxter-may-test-immune-system-drug.html The claims analysis indicated the risk of developing Alzheimer's and related disorders might be reduced in patients previously treated with Gammagard, also known as intravenous immunoglobulin, or IVIG. Baxter may test immune-system drug for Alzheimer's BY BRUCE JAPSEN Baxter International Inc.'s immune-system-boosting drug appeared to show... [[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: I am an Alzheimer's Caregiver) I am an Alzheimer's Caregiver blogs http://www.medworm.com/rss/comments.php?id=1286510 Fri, 07 Mar 2008 19:20:23 +0100 1286510 http://www.medworm.com/index.php?rid=1286449&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247390761%2F In recent weeks, there has been nothing but bad news coming out of China. A Chinese facility that made the active ingredient in Baxter’s Heparin blood thinner remains a key suspect behind nearly 800 serious side effects and 19 deaths. A big state-owned Chinese drugmaker, Shanghai Hua Lian, that exports to dozens of countries, including the US, caused a scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise hurt last year by contaminated leukemia drugs. The company supplies the active ingredient for the RU-486 abortion pill. Yet China has an estimated 80,000 chemical companies, and the FDA doesn’t know how many sell ingredients used in drugs consumed by Americans. Meanwhile, more drugmakers are growing operations in China. (Look here and here). And so last mont... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1286449 Fri, 07 Mar 2008 13:58:11 +0100 1286449 http://www.medworm.com/index.php?rid=1283628&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246979058%2F The Heparin scandal is taking on international dimensions. The FDA says that German regulators have now received reports of serious adverse events caused by Heparin, but this version of the blood thinner doesn’t contain an active ingredient made by the Chinese company that supplied Baxter International. However, the agency didn’t identify the source of the Heparin that is causing problems in Germany, other than to say the supplier is not a US company. The German manufacturer is Rotexmedica. It remains unclear, though, the extent to which the problem may extend to other versions of Heparin made by still other companies in other countries. The investigation is “still evolving,” says Janet Woodcock, an FDA deputy commish, during a telebriefing with the media. She did, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1283628 Thu, 06 Mar 2008 21:11:47 +0100 1283628 http://www.medworm.com/index.php?rid=1280990&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246286544%2F The disclosure was made during the latest briefing given by the agency, which is under siege for, among other things, failing to inspect a plant in China that supplied the active ingredient for Baxter’s Heparin, a blood thinner that has been linked to nearly 800 serious side effect reports and at least 19 deaths in the US. In a teleconference call this afternoon, FDA deputy commmish Janet Woodcock, who heads the agency’s drug review center, calls the contaminant a ‘Heparin-like compound’ and say that it accounted for anywhere between 5 percent and 20 percent of the active pharmaceutical ingredient and finished product tested. However, she adds that, while there is an association, there is “no direct causal link between the contaminant and the adverse events.&#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1280990 Wed, 05 Mar 2008 18:49:07 +0100 1280990 http://www.medworm.com/index.php?rid=1274967&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F244994259%2F The nitty-gritty and nuances may not yet be known, but some insights can be gleaned into what Baxter did - and didn’t do - as the Heparin controversy unfolded by reading The Chicago Tribune. The paper pieced together a chronology along with some context into the problems surrounding the FDA and plant inspections, in general. To underscore its command of crisis management, Baxter tells the paper that its ceo, Bob Parkinson, began having early meetings each day and made regular surprise visits to other execs to learn what was going on. And that’s how he learned that the FDA never inspected the Chinese plant suspected as the culprit behind the questionable blood thinner. Baxter, however, wasn’t forthcoming about everything. For instance, the Trib writes that a doc at St. Lo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1274967 Mon, 03 Mar 2008 18:08:15 +0100 1274967 http://www.medworm.com/index.php?rid=1271273&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F03%2Fheparin-in-era-of-hogwash.html Two weeks ago we first posted about an emerging scandal about the production of the drug heparin, a biologic that has been in use for over 70 years. First, we posted about the sudden increase in the frequency and severity of adverse effects due to heparin that carried the Baxter International label. However, its "active ingredient," that is, the heparin itself, was purchased from Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.Last week, we posted about how the CEOs of Baxter Interna... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1271273 Sat, 01 Mar 2008 22:21:00 +0100 1271273 http://www.medworm.com/index.php?rid=1269675&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F243553348%2F The FDA took great pains yesterday to provide an update on the Heparin scandal. You know, that’s one in which a few hundred people reported serious side effects, and four deaths were also linked to the Baxter blood thinner. And then the FDA acknowledged the Chinese plant, which is run by a supplier to Baxter, was never inspected, because of some snafu involving paperwork and incorrect names and who-knows-what-else. So the latest tidbit revealed by the agency is that the plant was finally inspected. Of course, the stumblebums at the FDA scheduled the teleconference without posting the inspection report on the agency web site, which meant the media couldn’t ask any pertinent questions about the findings. The upshot, however, is that the inspectors found a bunch of problems. What ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1269675 Fri, 29 Feb 2008 21:49:31 +0100 1269675 http://www.medworm.com/index.php?rid=1266666&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F242969261%2F The move was disclosed this afternoon by the FDA, which provided an update on the controversy over side effects and deaths linked to Baxter’s widely used blood thinner. During the teleconference with the media, agency officials said they had completed an inspection of the Chinese facility that supplied the active pharmaceutical ingredient to Baxter, but have still not identified the ‘root cause’ of the problem. “We’ve identified a number of potentially objectionable conditions,” said Michael Rogers, director of the Division of Field Investigations in the FDA’s Office of Regulatory Affairs, who added that the supplier isn’t currently manufacturing. Among the problems he cited with the plant in Changzhou, China, which is owned by Scientific Pro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1266666 Thu, 28 Feb 2008 22:28:30 +0100 1266666 http://www.medworm.com/index.php?rid=1260035&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241935514%2F China’s drug safety agency says it enforces strict controls on chemicals used in pharmaceuticals, but that importing countries are ultimately responsible for ensuring product safety, the Associated Press reports. The State Food and Drug Administration, in a statement on its Web site, says it is cooperating with a US probe into a factory that makes Heparin, a blood thinner sold by Baxter International that is subject to a massive recall due to some 350 adverse patient reactions and four deaths. “We attach high importance to this,” the agency said in its first comment on the Heparin recall. SFDA officials have not responded to repeated inquiries about the case. But the SFDA says that, based on international practice, “safeguarding the legality, safety and quality of r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1260035 Wed, 27 Feb 2008 06:53:03 +0100 1260035 http://www.medworm.com/index.php?rid=1248885&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F02%2Fheparin-made-out-of-pigs-from-elsewhere.html Last week, we discussed what was known about the sudden increase in the frequency and severity of adverse effects due to heparin, an anti-clotting drug that has been in use for more than 7o years. The heparin all carried the Baxter International label, but its "active ingredient," that is, the heparin itself, was purchased from Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.First, the Wall Street Journal reported how heparin is made in China.In a small, damp factory here [in Yuanlou... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1248885 Fri, 22 Feb 2008 04:45:00 +0100 1248885 http://www.medworm.com/index.php?rid=1239363&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F237123109%2F An FDA official says the failure to inspect the Chinese plant that produced the active ingredient in Baxter’s Heparin was due to a mistake in paperwork submitted to the agency. The FDA received an incorrect name on the Heparin application, which meant the agency apparently wouldn’t have known to inspect the Changzhou SPL facility that supplies the ingredient to Baxter, according to Joseph Famulare, deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “This facility is an isolated instance right now,” Famulare says in a teleconference call with the media. “It was not the correct firm named in application…We’ve discovered that, we’re acting upon that. We’re looking at this process and not... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1239363 Mon, 18 Feb 2008 19:06:05 +0100 1239363 http://www.medworm.com/index.php?rid=1236930&cid=t_109117_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F02%2Fin-middle-of-all-those-pigs-in-china.html The case of the allergenic heparin seems to be opening up a new window on how US pharmaceutical industry is managed, or mismanaged. The story started with reports of unusual numbers of allergic reaction, many serious, to parenteral heparin, a drug in use for over 70 years to reduce blood clotting. Most of the afflicted patients were dialysis patients who get large doses (boluses) of heparin to prevent blood clots during dialysis. The reactions included "nausea, difficulty breathing and rapidly falling blood pressure that can lead to death." The reactions affected patients receiving heparin from multi-use vials made by Baxter International. "About 350 events linked to Baxter's heparin have been reported since the end of last year compared with less than 100 reports in 2007." Baxter recalled... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1236930 Sat, 16 Feb 2008 18:38:00 +0100 1236930 http://www.medworm.com/index.php?rid=1237094&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F236071661%2F A Chinese factory that supplies much of the active ingredient for Baxter’s Heparin, which has been linked to hundreds of adverse reactions and four deaths in the US, isn’t certified by China’s drug regulators to make pharmaceutical products, The New York Times reports. As a result, China’s drug agency never inspected the plant run by Changzhou SPL. Earlier this week, the FDA acknowledged it never inspected the plant either. Although Chinese drug regulators have said that all ingredient producers are required to obtain certification, some chemical companies don’t fall under the Chinese drug agency’s jurisdiction. The Changzhou plant hasn’t been accused of providing a harmful product. But in response to questions, Scientific Protein, which is a majority owne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1237094 Sat, 16 Feb 2008 13:01:24 +0100 1237094 http://www.medworm.com/index.php?rid=1236367&cid=t_109117_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=1234808&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235653651%2F The distance between Changzhou in China to Baxter International in Illinois is, symbolically, as long as a pig intestine. Baxter’s Heparin, you see, is derived from piggie innards, but the blood thinner has also been linked to some 350 adverse events, many of which were serious, and four deaths. And the episode is casting another harsh spotlight on the ability of the FDA to supervise drugmaking in China, which is fast becoming the equivalent of pharma’s Wild West. In this case, the active ingredient in Heparin was supplied by a Chinese manufacturing facility co-owned by a Wisconsin company, Scientific Protein Laboratories, which has manufacturing facility in China and a joint-venture operation called Changzhou, The Wall Street Journal reports. “There’s nothing that ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1234808 Fri, 15 Feb 2008 17:08:15 +0100 1234808 http://www.medworm.com/index.php?rid=1234812&cid=t_109117_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=1233328&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235254770%2F Another busy day draws to a close. At least for now. Who knows what may turn up later? Maybe another high-ranking exec will suddenly resign? Nonetheless, we will break to entertain one of the short people and check back later. We will also compile the results of our two latest unscientific polls - one concerning Fred Hassan, and the other about Andy Bonfield at Bristol-Myers Squibb. Meanwhile, these should help you keep busy….. Carl Icahn dumped his Genzyme shares, according to Xconomy.com. Regulatory filings posted today show that during the fourth quarter of 2007 the activist investor dumped all 1.5 million shares he bought in Genzyme during the third quarter. You may recall that Genzyme ceo Henry Termeer in December told Carl to go away, but the site speculates the real reason Car... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1233328 Fri, 15 Feb 2008 04:33:23 +0100 1233328 http://www.medworm.com/index.php?rid=1232041&cid=t_109117_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1443 If the recent Science Board report on science within the Agency wasn’t enough and you needed more evidence of the urgent need for better IT infrastructure, staffing and other resources for FDA, the Wall Street Journal released this bombshell this morning.  Click here to read.   Baxter’s recalled generic Heparin may be linked to API manufactured by a [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1232041 Thu, 14 Feb 2008 16:05:10 +0100 1232041 http://www.medworm.com/index.php?rid=1230421&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234627176%2F A Chinese facility that has never been inspected by the FDA made the active ingredient in Baxter International’s Heparin blood thinner, which the agency is now reviewing after 350 reports of allergic reactions and four deaths among its users, The Wall Street Journal reports. An FDA spokeswoman said the plant making the active ingredient “was supposed to be inspected,” but “due to human error, and inadequate information-technology systems, a pre-approval inspection, which would normally be conducted, was not.” Currently, she tells the paper, “preparations are being made to perform an inspection as soon as possible.” The FDA has inspected a Cherry Hill, N.J., facility where the finished version of the drug was made, but adds, but couldn’t provi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1230421 Wed, 13 Feb 2008 23:07:14 +0100 1230421 http://www.medworm.com/index.php?rid=1222428&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F233303329%2F The drugmaker has temporarily halted production of multiple-dose vials of the injectable blood-thinning drug due to reports of serious allergic reactions and low blood pressure in patients who receive high “bolus” doses, the FDA says. Serious reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear, according to the agency. About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007, the FDA says. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1222428 Mon, 11 Feb 2008 18:58:10 +0100 1222428 http://www.medworm.com/index.php?rid=1204681&cid=t_109117_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229159965%2Frecalled_heparin_causes_allergic_reaction_in_dialysis_patients.html The Center for Disease Control and Prevention announced that they are investigating 53 incidents of dialysis patients having developed allergic reactions after receiving injections of heparin made by Baxter Healthcare Corp.Last week Baxter voluntarily recalled specific batches of heparin due to reports of adverse events however, the extent of the problem was unknown until the CDC released the information on Friday.The recalled batches have been tested for bacteria and endotoxin but neither was present. "We don't know what the problem is," but heparin remains the leading candidate as the cause, said Dr. Priti Patel, a CDC investigator.To prevent blood clotting during the dialysis process, kidney patients receive heparin and the allergic reaction occured within minutes of ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1204681 Mon, 04 Feb 2008 19:00:50 +0100 1204681 http://www.medworm.com/index.php?rid=1185817&cid=t_109117_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F225446624%2Fbaxter_issues_urgent_recall_of.html Baxter Healthcare Corporation has issued an immediate voluntary recall of nine lots of heparin sodium injection 1000 units/ml and 30 ml multi-dose vials.The lots recalled are:NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111"Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1185817 Tue, 29 Jan 2008 18:00:08 +0100 1185817 http://www.medworm.com/index.php?rid=1070374&cid=t_109117_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F195204757%2F The actor and his wife sued the heparin maker after their newborn twins were inadvertently given massive doses of the blood thinner at a hospital, the Associated Press reports. The product liability lawsuit seeks more than $50,000 in damages and claims Baxter Healthcare was negligent in packaging different doses of the product in similar vials with blue backgrounds. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital last year. The lawsuit was first reported by CelebTV.com, which obtained the court documents. A call to Baxter Healthcare seeking comment wasn’t immediately returned, the AP writes. The Quaids’ two children and a third patient were at Cedars-Sinai Medical Center on Nov. 18 w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1070374 Tue, 04 Dec 2007 23:56:57 +0100 1070374 http://www.medworm.com/index.php?rid=559943&cid=t_109117_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110977289%2Fbaxters_inhaled_insulin_passed.html Baxter Healthcare Corporation’s Phase I study of its pulmonary insulin administered using a small, standard dry powder inhaler demonstrated that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. The inhaled insulin, called recombinant human insulin inhalation powder (RHIIP) is made using Baxter's proprietary PROMAXX formulation technology that unlike other dry powder formulations of insulin is 95 percent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung. The study found no serious adverse events of the inhaled insulin in the subjects and demonstrated that RHIIP had a faster onset of action than SC (time to reach 10 percent of tota... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=559943 Sun, 22 Apr 2007 06:04:51 +0100 559943 http://www.medworm.com/index.php?rid=515921&cid=t_109117_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105910989%2Fbaxters_adjuvantfree_h5n1_flu.html Baxter International Inc. (NYSE: BAX) has recently announced the successful results of its final Phase I/II clinical trial for its adjuvant-free investigational pandemic H5N1 influenza vaccine. Baxter's candidate H5N1 vaccine is derived from H5N1 strain A/Vietnam/1203/2004. Its antigen composition and structure closely resembles the actual pathogen circulating in nature. The candidate vaccine induces an immune response (both cell and antibody mediated) that is similar to the body's defense against a natural virus, without the need to incorporate additional agents (adjuvants) to enhance immune response.Clinical data revealed that Baxter's H5N1 candidate vaccine is highly immunogenic at low doses, and induces substantial levels of cross immunity against widely divergent H5N1 stra... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=515921 Mon, 02 Apr 2007 02:54:42 +0100 515921