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 'heparin'. Sat, 03 Sep 2011 02:01:56 +0100 http://www.medworm.com/index.php?rid=5181703&cid=t_114650_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=4984688&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F00EJHTbmsSw%2F Three years after the FDA linked the Heparin scandal to contaminated supplies from China, the House Energy and Commerce Committee is expanding a probe into the episode and wrote 10 drugmakers, manufacturer reps and ingredients suppliers for documents, because the agency has indicated they have info about the Chinese heparin industry and supply chains. The move comes after the committee has twice lashed out at the FDA for failing to find those responsible for the scandal, which was linked to 81 deaths in 2007 and 2008 and traced to heparin sold by Baxter International (back story). The fatalities provoked harsh criticism of the FDA for not conducting greater oversight of foreign facilities - particularly those in China that make medicines or supply active pharmaceutical ingredients. Baxter... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984688 Thu, 30 Jun 2011 11:55:31 +0100 4984688 http://www.medworm.com/index.php?rid=4934029&cid=t_114650_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_114650_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=4715019&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWxRg5kRjTGc%2F Once again, several House Democrats have introduced a bill designed to increase funding and authority for the FDA to monitor drug production. The latest legislation, however, is aimed specifically at foreign-made pharmaceuticals, given ongoing concerns about the supply chain amid several episodes that questioned foreign production of meds sold in the US. The new bill, which is called the Drug Safety Enhancement Act and was sponsored by John Dingell, a Michigan Democrat, and three of his colleagues, would provide added funding to the FDA to inspect drugs imported into the US, increase civil and criminal penalties, and increase agency inspection of overseas manufacturing to the same level of scrutiny applied to domestic facilities (to read the bill, please go here and type in HR 1483). &#822... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715019 Thu, 14 Apr 2011 15:18:38 +0100 4715019 http://www.medworm.com/index.php?rid=4704959&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOvRuuYAAJLA%2F And the revolving door keeps revolving. Former Congressman Bart Stupak, who gained a high profile and occasional notoriety for his watchdog approach toward the pharmaceutical industry and the FDA, has just signed on as a legislative and government affairs partner with Venable, a law firm that has a sizeable practice helping drug and device makers. “I’ve had numerous contacts with Venable partners over the years and am excited about helping my new colleagues and the firm’s clients navigate choppy congressional waters,” says Stupak, a former police officer, Michigan state trooper and nine-term congressman, in a statement e-mailed to us. This will be a decidedly different role for Stupak. As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704959 Mon, 11 Apr 2011 16:41:59 +0100 4704959 http://www.medworm.com/index.php?rid=4592691&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5cPetg5jHnI%2F For those wondering about the difficulties confronting the FDA as the agency attempts to monitor the supply chain, the chart offers some insight. From roughly 1,200 foreign manufacturing plants in 2001, the number grew to more than 3,500 in 2008 - a 185 percent increase. Yet the number of FDA inspections rose 23 percent, leading to a 57 percent drop in the inspection rate. [UPDATE: In 2001, 20.7 percent of facilities were inspected, but only 8.9 percent in fiscal year 2008]. In China alone, the problem is daunting. There are nearly 1,000 manufacturers of drug substances eligible for FDA inspection. And for 89 percent of audited Chinese-made drug substances, US and European pharmaceutical purchasers fail to demand the mandatory Chinese license and certificate, according to Philippe André o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592691 Tue, 15 Mar 2011 12:15:33 +0100 4592691 http://www.medworm.com/index.php?rid=4522286&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc4iwc7RTeus%2F Two years ago, Pfizer trumpted a deal in which Aurobindo, a large supplier of active pharmaceutical ingredients that is based in India, would make a few dozen generic meds for the brand-name drugmaker. The move was part of a grand plan to expand into generics with lower manufacturing costs and revive growth as patents on big-selling, brand-name meds began expiring. “These agreements represent solid, measurable progress, and a strong commitment to achieve our growth objectives,” said David Simmons, who heads the drugmaker’s emerging markets and established products units, in a statement. Established products is a Pfizer euphemism for generics and branded generics. “We will dramatically change Pfizer’s Established Products portfolio to an engine of positive growth.” Since... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522286 Fri, 25 Feb 2011 15:51:21 +0100 4522286 http://www.medworm.com/index.php?rid=4517139&cid=t_114650_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=4512610&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F01Pd_tGjLqE%2F Three years after the FDA linked the Heparin scandal to contaminated supplies from China, a Congressional committee has lashed out at the agency for failing to find the culprits behind the episode and has now written FDA commish Margaret Hamburg to release all documents related to the agency investigation. You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 (back story), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there (background). “There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the (United States),&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512610 Thu, 24 Feb 2011 00:14:19 +0100 4512610 http://www.medworm.com/index.php?rid=4450520&cid=t_114650_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_114650_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_114650_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=4277958&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxWGxZrIn9t4%2F As promised, a handful of House Democrats have introduced legislation that would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US. The bill would crreate an up-to-date registry of all domestic and foreign facilities serving the US; generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs; require parity between foreign and domestic inspections; prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections; prohibit drugs from entering the US if safety documentation is lacking; requires manufact... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277958 Tue, 21 Dec 2010 14:38:54 +0100 4277958 http://www.medworm.com/index.php?rid=4225186&cid=t_114650_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_114650_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=4152272&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEol_ZBMUqs%2F Good morning, folks. How are you today? We are just fine, thank you. After all, the sun is shining here on the Pharmalot corporate campus, where the official mascots are chasing squirrels and two cups of stimulation are brewing. What will today bring? Hmm… One never knows, but to help you prepare, we have gathered a few interesting tidbits of information. So dig in. And we hope your day goes well… PhRMA CEO John Castellani On Elections And Health Care Reform (Politico) Merck Results For Cholesterol Pill Are Due Next Week (Bloomberg News) FDA Commish Defends Handling Of Heparin Crisis (Reuters) Glaxo Sees More Industry Consolidation (The Business Standard) Pharma Needs Lessons On Winning Trust (MedAd News) Court Is Urged To Narrow Patent-Misconduct Standard (Bloomberg News) FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152272 Wed, 10 Nov 2010 12:39:39 +0100 4152272 http://www.medworm.com/index.php?rid=4134260&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHPMS6t7D2ow%2F At a time when the FDA is increasingly criticized for its oversight of foreign drug-making plants, the chief of its recently created International Compliance Branch has departed. Earlier this week, Edwin Rivera-Martinez, a 20-year agency veteran, joined Parexel International, the contract research organization, as technical vp for strategic compliance services. In his role at the FDA, he oversaw compliance for inspections of human drugs and active pharmaceutical ingredients that are conducted abroad by the FDA. This is a crucial function at the agency, especially given the Heparin scandal in which more than 80 deaths and hundreds of serious reactions in patients three years ago. The cause was a contaminated ingredient from China, and some members of Congress have lambasted the FDA for fail... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134260 Thu, 04 Nov 2010 11:22:46 +0100 4134260 http://www.medworm.com/index.php?rid=4106055&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWTWwWrCyCEM%2F The bitter contest over bringing a generic Lovenox bloodthinner to market took another unusual turn yesterday when Amphastar Pharmaceuticals filed a lawsuit against the FDA, charging the agency with unlawfully detaining two shipments of raw materials need to make its version of the widely used drug. The move comes three months after the FDA approved a generic developed by Momenta Pharmaceuticals, which has a marketing deal with the Sandoz generic unit of Novartis (back story). This is only the latest instance in which Amphastar has railed against the FDA’s handling of the Lovenox wars. Last year, Amphastar charged there was a conflict of interest at the agency, because Janet Woodcock, who oversees the agency’s Center for Drug Evaluation and Research, had an alleged working rela... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106055 Tue, 26 Oct 2010 13:32:19 +0100 4106055 http://www.medworm.com/index.php?rid=4073991&cid=t_114650_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=3876592&cid=t_114650_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=3865462&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fq2qUgAD-wQM%2F Well, what do you expect Margaret Hamburg to say? There she is in Shanghai, touring some facility with Chinese government officials who, of course, will do their best to make sure she doesn’t catch a whiff of a contaminated active ingredient or come within 100 miles of a gray market supplier. And there is international diplomacy to consider, after all - who buys all that US government debt? Despite being labeled a paper tiger by a pair of Congressman who are angry over the lack of progress into the Heparin probe (see here), the FDA commish was all smiles as she explained her view of the relationship between her agency and its Chinese equivalent. “I leave feeling very encouraged by the partnership we’ve developed here,” Hamburg tells the Associated Press. “This... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865462 Fri, 13 Aug 2010 11:59:18 +0100 3865462 http://www.medworm.com/index.php?rid=3795054&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-ypN_wd8wVc%2F Stunned by the FDA approval of a generic version of its best-selling Lovenox blood thinner, Sanofi-Aventis has filed a lawsuit in federal court, charging the agency with exceeding its authority, and acted arbitrarily and capriciously in granting Momenta Pharmaceuticals the right to market a drug (see background here). In arguing its case, Sanofi claims the FDA is allowing a generic to be sold that is not similar in safety or efficacy to Lovenox, which generated $4 billion in sales last year. And so Sanofi is seeking a temporary restraining order to force the FDA to withdraw approval, which would prevent Momenta and its partner, the Sandoz generic unit of Novartis, from moving forward. Sanofi has moved aggressively before to thwart generic Lovenox, filing a citizen’s petition with the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795054 Tue, 27 Jul 2010 13:05:42 +0100 3795054 http://www.medworm.com/index.php?rid=3784497&cid=t_114650_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_114650_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=3780563&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXTWINzuP128%2F The FDA may want to get tough with drugmakers that outsource production (see this), but how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation. You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 (back story), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there (background). Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger. “It is sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780563 Thu, 22 Jul 2010 15:50:07 +0100 3780563 http://www.medworm.com/index.php?rid=3767034&cid=t_114650_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=3726580&cid=t_114650_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fsanofi-funded-society-of-hospital.html Here is another case to raise questions about the true goal of some medical societies.  As reported by Alicia Mundy in the Wall Street Journal in late June, A medical researcher and two medical groups with financial ties to Sanofi-Aventis SA have asked federal regulators to hold off on approving generic forms of a Sanofi blood-thinner....Citing potential patient safety issues, the head of the Society of Hospital Medicine and a medical researcher at Duke University last month sent letters to the Food and Drug Administration contending that Lovenox is too complex for any generic maker to copy fully.Earlier this year, another Sanofi-sponsored medical group, the North American Thrombosis Forum, sent two letters in favor of Sanofi's position opposing generic Lovenox. None of the letters me... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3726580 Mon, 05 Jul 2010 20:22:00 +0100 3726580 http://www.medworm.com/index.php?rid=3542605&cid=t_114650_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fa-look-at-the-history-of-microsurgery%2F2010.05.06 Facial transplants, hand replants, and free flaps are only possible in large part due to microsurgery.  I finally got around to reading the “History of Microsurgery.” The article is good reading for anyone interested in the history of microsurgery. The article, written by Susumu Tamai, M.D., Ph.D., (Japan) was received for publication in Plastic & Reconstructive Surgery on June 14, 2007. Microsurgery is relatively young, and Dr. Tamai breaks down the history into four periods. (more…) *This blog post was originally published at Suture for a Living* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3542605 Thu, 06 May 2010 18:00:00 +0100 3542605 http://www.medworm.com/index.php?rid=3538045&cid=t_114650_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=3519711&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7Najfs7cscE%2F And so another working week will soon draw to a close. As always, we look forward to spending time with the short people - a game of miniature golf, in fact, is in order. And, of course, there are those lacrosse games. What about you? A quiet ride in the country? A nice meal with a favorite person? How about a walk in the park? Whatever you fancy, we hope you have a wonderful time. Meanwhile, here are a few items to help you round out the day. Have a good one…. Glaxo Heart Drug Gets Boost From Study (Reuters) After Approval: What’s Next For Dendreon? (Seeking Alpha) Diabetes Death Watch Slipped Into Health Reform (Bloomberg News) Tripe-Based Drug Hits Gold (The New York Times) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519711 Fri, 30 Apr 2010 11:56:13 +0100 3519711 http://www.medworm.com/index.php?rid=3486996&cid=t_114650_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=3460395&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr4doEN28UV4%2F The answer is unclear, although no doubt many pharma execs and FDA officials won’t miss Bart Stupak, a Michigan Democrat who is retiring from Congress after a nasty brawl over health care reform and, in particular, abortion coverage (background here). As chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee, Stupak regularly took on safety issues. Along with John Dingell, who formerly headed the House committee, Stupak investigted Merck and Schering-Plough for allegedly delaying the release of unfavorable clinical trial data for their Vytorin cholesterol med (see here and here). He also subpoenaed FDA investigators for approving the Ketek antibiotic, despite knowing a key safety study was fraught with problems; Sanofi-Aventis execs wer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3460395 Mon, 12 Apr 2010 12:21:04 +0100 3460395 http://www.medworm.com/index.php?rid=3425126&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcIYm9Ly7a58%2F Back in 2008, private eyes working for Amphastar Pharmaceuticals gathered info about Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, collecting details about her husband, two daughters, and in-laws, and retracing her steps on a business trip she took to Thailand, writes Politico, which essentially rehashes and fleshes out a juicy piece in The Wall Street Journal last fall (see here). Amphastar paid more than $100,000 to Kroll for the low down. At one point, the investigators hired a freelance reporter to file Freedom of Information Act requests, using her status as a journalist to request Woodcock’s emails, phone records, voicemails, calendar and expense reports, among other documents – without mentioning that she was being paid for her efforts by a p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3425126 Wed, 31 Mar 2010 11:54:10 +0100 3425126 http://www.medworm.com/index.php?rid=3335567&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPH9ZazU-oc0%2F A hearing on drug safety is scheduled for next Wed., March 10, and will be held by the House Energy & Commerce committee’s subcommittee on Health. And the featured speaker will be deputy FDA commish Josh Sharfstein, as well as other FDA folks, according to The Pink Sheet. No particular reason was cited, but the impetus for the hearing isn’t being attributed to Avandia. You may recall the GlaxoSmithKline diabetes pill was the subject of a recent Senate Finance Committee report that found internal dissent among FDA staffers over what to do about cardiovascular risks (see here). Importation, however, is expected to be on the agenda. The hearing will be held because the committee hasn’t had any public discussion of drug safety since the FDA Commissioner Margaret Hamburg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3335567 Fri, 05 Mar 2010 15:00:57 +0100 3335567 http://www.medworm.com/index.php?rid=3244048&cid=t_114650_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_114650_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=2950992&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYp1hnhtvkSA%2F The race between two drug makers to market a generic version of a blockbuster blood thinner has grown so intense that one company hired the Kroll detective and security firm, prompting an inquiry by two key senators, The Wall Street Journal reports. Both Amphastar Pharmaceuticals and Momenta Pharmaceuticals hired high-profile Washington lobbyists as they await FDA approval for generic versions of low-molecular-weight heparin. In 2007, the FDA told Amphastar its prototype chemically matched Lovenox - the only available version. But the FDA unexpectedly set added safety requirements for heparin. Both companies submitted more data. You may recall earlier this year, Amphastar filed a complaint with the FDA against its own Janet Woodcock, saying she had a conflict of interest over heparin due ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2950992 Mon, 02 Nov 2009 13:13:07 +0100 2950992 http://www.medworm.com/index.php?rid=2699587&cid=t_114650_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=1939684&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F444688666%2F The Heparin scare continues. US Marshals grabbed 11 lots of Heparin from Celsus Laboratories in Cincinnati, Ohio - five lots of Heparin Sodium active pharmaceutical ingredient and six lots of Heparin Lithium. The products were made from material imported from China and were OSCS, a substance that mimics heparin’s anticoagulant activity, according to the FDA. The FDA informed Celsus Labs during an April 2008 inspection and again in a May 8, 2008, letter that its actions to notify customers about a contaminant in its Heparin were insufficient to assure an effective recall, according to an agency statement. So far, the FDA has initiated 13 recalls of multiple contaminated medical products containing Heparin from several companies (background here and here). Celsus has distributed Heparin ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1939684 Thu, 06 Nov 2008 19:39:49 +0100 1939684 http://www.medworm.com/index.php?rid=1930403&cid=t_114650_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=1811490&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F397245755%2F Why? Earlier this week, the FDA issued an import alert that allows authorities to stop Ranbaxy drugs and ingredients from entering the US, and issued warning letters for failing to meet manufacturing standards at two plants in India. And the Justice Department alleges Ranbaxy used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors (back story here and here). Nonetheless, the FDA says its move has nothing do with drugs or active pharmaceuticals ingredients made at Ranbaxy’s other plants, which the FDA has inspected and determined meet requirements for drug manufacturing. In fact, the agency recommends consumers continue taking their existing Ranbaxy meds and “not disrupt their drug ther... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1811490 Fri, 19 Sep 2008 14:17:48 +0100 1811490 http://www.medworm.com/index.php?rid=1714174&cid=t_114650_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2541 At the American Chemical Society national conference last weekend, Rensselaer Polytechnic researcher Dr. Robert Linhart announced that his team may have built the first fully synthetic heparin. Whether or not you believe that the possibility of another contamination crisis of natural raw heparin exists, the potential for a heparin supply independent of the whims and [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1714174 Mon, 18 Aug 2008 16:56:49 +0100 1714174 http://www.medworm.com/index.php?rid=1668707&cid=t_114650_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=1594008&cid=t_114650_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_114650_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_114650_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=1442828&cid=t_114650_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F05%2Fwho-moved-my-cheese.html Actor Dennis Quaid told Congress on Wednesday that taking away the right to sue pharmaceutical companies would turn consumers into "uninformed and uncompensated lab rats." "Like many Americans, I believed that a big problem in our country was frivolous lawsuits," Quaid testified. "But now I know that the courts are often the only path to justice."More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1442828 Thu, 15 May 2008 09:50:00 +0100 1442828 http://www.medworm.com/index.php?rid=1426774&cid=t_114650_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_114650_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=1416442&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F282073184%2F When it comes to the Heparin scandal, about the only thing anyone can seem to agree is on that the FDA needs to conduct more inspections of foreign manufacturing facilities. But how this would be accomplished - and funded - is the big question. And a congressional hearing yesterday seemed to do little to provide an answer. A bill proposed by John Dingell, the Michigan Democrat who chairs the House Energy and Commerce Committee, would impose an annual fee for all domestic and foreign drugmakers to defray the costs. Foreign drugmakers would have to be inspected every two years like domestic manufacturers, a requirement that doesn’t exist right now. Industry trade groups told Congress they’re willing to discuss a new user-fee system, within limits. Their issues include the size o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1416442 Fri, 02 May 2008 12:24:39 +0100 1416442 http://www.medworm.com/index.php?rid=1413423&cid=t_114650_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_114650_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_114650_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=1405331&cid=t_114650_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Fblogscan-regulatory-capture-heparin-and.html On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discusses the recent case of toxic heparin (see our most recent post here) in terms of "regulatory capture" of the US Food and Drug Administration (FDA). Regulatory capture occurs when a regulatory agency starts to view those whom it is supposed to regulate as clients (rather than viewing the general public as its client). More comments on this issue by Dr James Gaulte can be read on the Retired Doc's Thoughts blog. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1405331 Mon, 28 Apr 2008 20:24:00 +0100 1405331 http://www.medworm.com/index.php?rid=1399366&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277564852%2F And so the week is quickly drawing to a close. Still, today is another day - a meeting or deadline may loom somewhere. So here are a few items to help you keep up with the world at large. As for us, we will take a quick break to feed the Pharmalot mascot and grab the cherished cup of coffee, but will return momentarily. Hope your day goes well… Wyeth, Progenics Bowel Drug Wins FDA Approval (Yahoo/Reuters) Amgen Reports Flat Earnings On Lower Sales (MarketWatch) Sweden Pulls Contaminated Sanofi Heparin Batches (Bloomberg News) EMEA Committee Approves Two Merck Drugs (Dow Jones) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1399366 Fri, 25 Apr 2008 11:22:42 +0100 1399366 http://www.medworm.com/index.php?rid=1393901&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F276182133%2F The chairman of the House Energy and Commerce Committee made his stinging remarks yesterday at a hearing held to review FDA oversight. As The RPM Report notes, Dingell (to the left) lost his patience with FDA commish Andy von Eschenbach, who once again refused to say how much money the agency needs to do its job, particularly inspect facilities. And so Dingell offered this: “I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can’t maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your j... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1393901 Wed, 23 Apr 2008 14:04:22 +0100 1393901 http://www.medworm.com/index.php?rid=1391295&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275595515%2F Members of a House Energy and Commerce Committee subcommittee chastised FDA commish Andy von Eschenbach today for not doing more inspections of foreign drug makers in the wake of the Heparin scandal and problems with numerous other products, the Associated Press reports. “Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people,” thundered Bart Stupak, a Democrate from Michigan, who chairs the Subcommittee on Oversight and Investigations. “If we don’t make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.” For his part, Andy told the lawmakers that he has asked the administration for more money to condu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391295 Tue, 22 Apr 2008 18:54:13 +0100 1391295 http://www.medworm.com/index.php?rid=1391299&cid=t_114650_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_114650_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_114650_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=1356371&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266347242%2F In the aftermath of the Heparin controversy, a zillion questions are being asked. And one involves greater disclosure concerning the origins of those materials used to make drugs. As Melinda Beck points out in her health column in The Wall Street Journal, the FDA requires drugmakers to disclose only the name and place of business of the manufacturer, packer or distributor of prescription medications. Active and inactive ingredients must be listed on the label, but not the raw materials or their origins, which are considered “commercial confidential.” PhRMA argues that making such info public would be neither practical nor helpful to consumers, and that what counts is that any med sold in the US must meet Good Manufacturing Practices set by the FDA, Beck writes. “The requi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1356371 Tue, 08 Apr 2008 13:22:40 +0100 1356371 http://www.medworm.com/index.php?rid=1329046&cid=t_114650_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=1327601&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258263468%2F The head of the agency’s Center for Drug Evaluation and Research is responding to criticism as she embarks on her second stint in this position. Talking to The Financial Times, Janet Woodcock insists that science, not politics, is the reason fewer new drugs are reaching the market. When the FDA rejects a new med, the decision is based on safety and effectiveness, not political pressure. “We have a different story from the companies. We understand that (they) have productivity issues but (we) stick to the same safe and effective criteria as our bedrock,” she tells the paper. “Pharma is having a difficult time but we are seeing drugs that have a lot of questions.” Interestingly, her remarks appear just as The Wall Street Journal writes that several big new drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1327601 Wed, 26 Mar 2008 12:02:25 +0100 1327601 http://www.medworm.com/index.php?rid=1327603&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258253610%2F The middle of the week is here and that can mean only one thing - plenty to do. Meetings, deadlines, projects. The list is long. So is ours. All of which tells us that the time has come for our daily cup of stimulation as we peruse the news of the world. Here are some of the latest developments to help you keep up. Hope your day goes well… Pfizer Sues Ranbaxy To Delay Generic Lipitor, Caduet (Bloomberg News) Sanofi Strikes Deal To Market Lilly’s Cialis In US (Bloomberg News) NIH Vows To Back AIDS Research (The Baltimore Sun) Denmark, France & Italy Recall Heparin (The Wall Street Journal) UK’s NICE Approves Sanofi’s Acomplia Diet Pill (Yahoo/Reuters) Vioxx Deadline Extended By One Month (BusinessWeek) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1327603 Wed, 26 Mar 2008 10:58:57 +0100 1327603 http://www.medworm.com/index.php?rid=1325474&cid=t_114650_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_114650_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_114650_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=1319576&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F255468155%2F Welcome back. We took an extended leave late yesterday to indulge in some holiday merrymaking. Now, though, we are refreshed and ready for all comers. The week may be winding down, but who knows what will happen? So let’s grab that cup of stimulation - we prefer coffee - or a bottle of water if that’s what the doctor ordered, and get down to business… AmeriSouce Recalls Heparin Vials (Yahoo/Reuters) UCB Recalls Parkinson’s Drug Patch (Bloomberg News) Roche And Actis Discuss Venture For Cancer Drugs (The Business Standard) Canada Appeals Court Backs Lipitor Patent (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1319576 Fri, 21 Mar 2008 11:26:23 +0100 1319576 http://www.medworm.com/index.php?rid=1316624&cid=t_114650_117_f&fid=34612&url=http%3A%2F%2Fwww.thedoctorweighsin.com%2Fjournal%2F2008%2F3%2F20%2Fthe-heparin-files-the-plot-thickens.html This article was written yesterday, Wednesday March 19, 2008. Today, the New York Times published this article: “Heparin Discovery May Point to Chinese Counterfeiting”. Did we score a scoop, or what! (Source: The Doctor Weighs In) The Doctor Weighs In blogs http://www.medworm.com/rss/comments.php?id=1316624 Thu, 20 Mar 2008 19:30:38 +0100 1316624 http://www.medworm.com/index.php?rid=1316820&cid=t_114650_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=1316697&cid=t_114650_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F254961565%2Ftainted-drugs.html For the sake of people susceptible to earworms everywhere, I won't actually parody the Soft Cell song further than using it as a title here. And as alliterative and 80s-referential as the title is,... [[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: Women's Bioethics Blog) Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1316697 Thu, 20 Mar 2008 14:59:42 +0100 1316697 http://www.medworm.com/index.php?rid=1314428&cid=t_114650_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=1314272&cid=t_114650_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F254496468%2F Big trouble again for the magic blood thinner Heparin. Health officials identified a contaminant in batches of the medication associated with 19 deaths and are trying to determine how the chemical got into the drug. The lots of heparin were recalled on the 28th of February and there has been no new deaths. The key ingredient in this case was imported from China. Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally. Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied. “We cannot rule in or out whether this was accidentally or deliberately introduced into the... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=1314272 Wed, 19 Mar 2008 20:45:41 +0100 1314272 http://www.medworm.com/index.php?rid=1314071&cid=t_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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=1287853&cid=t_114650_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F247591861%2Ffda_finds_contaminant_in_recal.html At the end of January Baxter Healthcare issued a voluntary recall of specific batches of their heparin products due to reports of adverse events. On Wednesday the U.S. Food and Drug Administration announced that test had revealed a "heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp." (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1287853 Fri, 07 Mar 2008 20:00:04 +0100 1287853 http://www.medworm.com/index.php?rid=1286449&cid=t_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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_114650_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=1248995&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F239030882%2F In the wake of the scandal over Heparin and the failure of the FDA to inspect the Chinese plant that supplied the active ingredient for the blood thinner, the House Energy and Commerce Committee has sent a letter to Mike Leavitt, the Health and Human Services Secretary, suggesting emergency legislation may be in the cards to “protect Americans from prescription medications that have been insufficiently investigated prior to approval.” “These Heparin tragedies are likely the result of FDA abandoning its preapproval inspection requirement, a critical policy was put in place two decades ago after a generic drug investigation by this Committee,” Dingell says in a statement. “This requirement was designed to protect consumers by ensuring that drug manufacturers operate... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1248995 Thu, 21 Feb 2008 21:41:31 +0100 1248995 http://www.medworm.com/index.php?rid=1245270&cid=t_114650_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F238209806%2F The Democrat from Michigan, who chairs the House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations is busier than ever. He’s probing the FDA’s handling of Baxter’s Heparin, the blood thinner linked to hundreds of patient reactions and four deaths; TV ads for Pfizer’s Lipitor; the release of Vytorin clinical-trial data by Schering-Plough and Merck; the marketing of anemia drugs sold by Amgen and Johnson & Johnson; and the review of clinical trial data for Sanofi-Aventis’ Ketek antibiotic. The common wisdom is that politicians are genetically inclined to beat up on the FDA and pharma, especially Democrats who control Congress and when an election year is under way. But there is more to it than that. In 2000, Stupak’s 17-... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1245270 Wed, 20 Feb 2008 14:58:04 +0100 1245270 http://www.medworm.com/index.php?rid=1239363&cid=t_114650_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=1237094&cid=t_114650_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_114650_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_114650_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_114650_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_114650_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=1230421&cid=t_114650_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_114650_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_114650_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_114650_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_114650_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=654449&cid=t_114650_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F06%2F02%2Fislet-transplantation-improves-with-drug-combination%2F Filed under: Type 1, Childhood, ResearchIslet transplantation is an exciting frontier of diabetes research as it can reverse diabetes. A recent study from researchers at the University of Alberta in Edmonton showed promising results when a combination of intensive insulin and heparin is used to garner better success of islet transplantation from a single donor. Due to inefficiencies in islet harvest, islet transplants usually require harvesting from more than one donor. Not only does the drug combination yield more islets from a single donor, early results suggest patients receiving islets from one donor realize longer insulin independence. Study researchers hypothesized heparin, an anticoagulant, could prevent damage from clotting, while intensive insulin could relieve stress and inflamm... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=654449 Sat, 02 Jun 2007 04:00:00 +0100 654449 http://www.medworm.com/index.php?rid=563660&cid=t_114650_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F111271841%2Flovenox_is_superior_over_unfra.html Results of Sanofi-aventis (NYSE: SNY)’ PREVAIL (Prevention of VTE after Acute Ischemic Stroke with LMWH Enoxaparin) trial has been published in the April 21st issue of The Lancet. Clinical data from the said trial revealed that once daily administration of Clexane® / Lovenox® (enoxaparin sodium injection) 40 mg was more effective than UnFractionated Heparin (UFH) 5000 IU twice a day for the prevention of VTE (venous thromboembolism) in patients who suffered an acute ischemic stroke. PREVAIL study showed a significant 43% relative risk reduction in VTE events was observed with Clexane® / Lovenox® vs. UFH for the primary efficacy endpoint, the composite of symptomatic or asymptomatic DVT, symptomatic and/or fatal PE during the treatment period (10.2 % vs. 18.1%; p= 0.00... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=563660 Mon, 23 Apr 2007 13:33:04 +0100 563660 http://www.medworm.com/index.php?rid=486690&cid=t_114650_105_f&fid=35048&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FMedicineAndMan%2F%7E3%2F17179420%2F Heparin-Induced Thrombocytopenia Endometriosis: What You Should Know Medicine Interactions with Grapefruit: What You Should Know Rickets: What It Is and How It’s Treated Pressure Ulcers Technorati Tags: Heparin induced thrombocytopenia, Endometriosis, Grapefruit, Rickets, Pressure sores, Patient pages (Source: Medicine and Man) Medicine and Man blogs http://www.medworm.com/rss/comments.php?id=486690 Tue, 29 Aug 2006 02:41:53 +0100 486690