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 'adverse'. Sat, 03 Sep 2011 01:54:27 +0100 http://www.medworm.com/index.php?rid=5159206&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F08%2F21%2Fthe-other-side-of-the-placebo-effect%2F This is the second in a pair of articles on the placebo effect. Nocebo is sometimes referred to as “placebo’s evil twin,” or the “negative placebo effect.”  It’s also sometimes described as “the other side of placebo.”   The nocebo effect can be defined as a negative effect that occurs after receiving treatment (therapy, medication), even when the treatment is inert (inactive, sham). It is important to note that negative effects seen when taking active substances, reported as drug side effects, can often be at least partly attributed to a a combination of effects from the substance’s constituents (specifics), and those from nocebo effects (non-specifics). Studies suggest that nocebo effects can contribute appreciably to a variety of medic... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=5159206 Sun, 21 Aug 2011 12:47:27 +0100 5159206 http://www.medworm.com/index.php?rid=5140250&cid=t_108521_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FFd53TmsH-k4%2Ftips-for-pharma-on-facebook.html Many Pharma companies are hesitant to use Facebook as a medium to communicate with their audience, and many fear it is because they will have additional worries concerning the FDA and adverse events of their drugs. Mashable recently set out and shared a few better ways for Pharma companies to communicate with their fans on Facebook while connecting with them at them at the same time. Some of the tips: - Know who is making the decisions about buying your product.  For example, doctors are not likely to reference Facebook when searching about a drug.  But for many Over the Counter drugs, consumers will look online and a Facebook page could be a great place to inform them about that drug. - Use the Facebook page as a way to communicate, connect and listen to your co... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140250 Fri, 12 Aug 2011 19:22:00 +0100 5140250 http://www.medworm.com/index.php?rid=5077688&cid=t_108521_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcan-pharmacogenomic-tests-help-to-improve-public-health%2F2011.07.29 Adverse drug events are a serious public health problem. Consider the following facts: an estimated 82% of American adults take at least one medication and 29% take five or more; 700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually; $3.5 billion is spent on extra medical costs of adverse drug events annually; at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented. How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended applications of pharmacogenomics research include identifying responders and non-responders to medications, avoiding adverse events, optimizing drug dose and avoiding unnece... Better Health blogs http://www.medworm.com/rss/comments.php?id=5077688 Fri, 29 Jul 2011 12:00:10 +0100 5077688 http://www.medworm.com/index.php?rid=5028071&cid=t_108521_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F07%2Fguest-blog-health-care-in-dangerous.html Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene.Health Care Renewal has often covered the disconnect between the stated goals of companies and the realities of their day to day operations. This raised the following question: Has medicine moved from being dysfunctional to being dangerous?There is certainly no lack of material to support this question as in the last two weeks we can find examples of pharma/biotech/device companies all engaged in questionable behavior. Medtronic and Manipulation of Study DataIn the print media, The Wall Street Journal, a pro-business newspaper regularly highlights storie... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5028071 Fri, 08 Jul 2011 20:02:00 +0100 5028071 http://www.medworm.com/index.php?rid=4968542&cid=t_108521_105_f&fid=36987&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FIvorKovicMd%2F%7E3%2Fv_fF9FquzRA%2F Just recently my colleague and I have published two research papers. I am very proud of the first one titled “Mobile phone in the Chain of Survival”, which was published after a lot of research in the Resuscitation journal. This short paper gives an overview of vast possibilities possessed by mobile phones to be of assistance in medical emergencies. It represents a continuation of my work with CPR mobile applications. I have also now published a video of the lecture I gave during the Resuscitation 2010 congress about the same subject. You can watch my 10 minute lecture here, and read our paper at the Resuscitation website. The second paper we wrote appeared in the Croatian journal Lijecnicki Vjesnik (in English this would be something like Physician’s Newsletter). It i... Ivor Kovic, M.D. blogs http://www.medworm.com/rss/comments.php?id=4968542 Sat, 25 Jun 2011 09:54:12 +0100 4968542 http://www.medworm.com/index.php?rid=4953360&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ_ALGGujptA%2F If at first you don’t succeed, try, try again? Last year at this time, the FDA chastised CSL, a big maker of flu vaccines based in Australia, for flunking an inspection that found several manufacturing deficiencies and, in addition to demanding a summary of corrective actions, agency officials took the unusual step of demanding a meeting with senior execs to review their plan (back story). Apparently, such meetings have absolutely no impact. The FDA has just issued a warning letter as a follow up to a March 2011 inspection, which generated a 483 report showing that CSL has no idea how to properly conduct an investigation to determine why fevers and convulsions were reported after children were given its products. Just the same, the FDA wants another meeting. But how bad was the effo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953360 Tue, 21 Jun 2011 14:09:08 +0100 4953360 http://www.medworm.com/index.php?rid=4945195&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-kPWew1MnL8%2F Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who are mostly farm workers and daily wagers, have developed acute joint pains, swelling in arms and throat infections. The brokers hired the women and took them to a lab in Miyapur, Hyderabad, where blood samples were taken and they were given injections and tablets, according to reports. For their trouble, the women were paid around 3,000 to 10,000 Rupees, or roughly $65 to $220, to participate in the trials that were conducted during last three months. “Though the pharma company promised to pay us huge amounts before conducting the te... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945195 Fri, 17 Jun 2011 12:28:48 +0100 4945195 http://www.medworm.com/index.php?rid=4934166&cid=t_108521_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcya-tmi-drug-label-warnings-list-dizzying-number-of-adverse-events%2F2011.06.15 Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients. Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs. Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psyc... Better Health blogs http://www.medworm.com/rss/comments.php?id=4934166 Wed, 15 Jun 2011 12:00:00 +0100 4934166 http://www.medworm.com/index.php?rid=4934484&cid=t_108521_113_f&fid=39278&url=http%3A%2F%2Fblogsite.mdbuyline.com%2F%3Fp%3D282 A blood coagulation test (prothrombin time test) that’s as easy to use as a home glucose meter and cheaper?  Wow!  Over 10% of all adverse drug events ending in a hospital stay are associated with blood thinners.  Because of this, regular monitoring is recommended to ensure the desired effect.  Unfortunately, the current technology is either costly or must be performed by qualified technicians. Currently, there are several point-of-care tests on the market, but the cost of the consumable test strips make it more expensive than laboratory testing.  However, the SmartStrip mimics “lab on a chip” technology but instead of fluidics, it’s based on microelectromechanical systems (MEMS) placed on a disposable test strip.  The result is a low-cost test that can be performed in minute... MD Buyline blogs http://www.medworm.com/rss/comments.php?id=4934484 Tue, 14 Jun 2011 13:39:53 +0100 4934484 http://www.medworm.com/index.php?rid=4945189&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Fbritish-pharmaceutical-industry-issues.html Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications (see here).I learned today from a tweet by @dawidge (a Pfizer employee) that the ABPI Pharmacovigilance Expert Network (PEN) published GUIDANCE NOTES ON THE MANAGEMENT OF ADVERSE EVENTS AND PRODUCT COMPLAINTS FROM PHARMACEUTICAL COMPANY SPONSORED WEBSITES (find the document here).The guidance addresses three different ways that pharmaceutical companies may learn of adver... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4945189 Tue, 14 Jun 2011 12:55:00 +0100 4945189 http://www.medworm.com/index.php?rid=4921430&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F06%2F09%2Fmrsa-vaccine-trial-is-halted-ends-in-disaster%2F Yesterday Reuters reported US Merck and Co have taken the very unusual step of discontinuing vaccine trials for Intercell’s MRSA vaccine. The decision was taken after experts advised the V710 vaccine was ‘unlikely to show a significant clinical benefit and expressed concerns about overall mortality and multi-organ dysfunction.’ The vaccine was set to have potential sales of more than $1.47 billion because it was to be a multi-flexible vaccine which could have been used for patients on admission to hospital, during surgery and in care homes for the elderly. Reuters reported in a press release today: “Merck is due to present the final detailed findings of the clinical trial at an upcoming medical meeting, the two groups said in a statement. “This is a significant ... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4921430 Thu, 09 Jun 2011 17:39:40 +0100 4921430 http://www.medworm.com/index.php?rid=4911824&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAutTWJ-YZYs%2F Faced with growing challenges in clinical trials, manufacturing and drug safety - among many other issues - the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology. The responsibilities will include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation, and supply chain integrity, among others, according to a memo from CDER director Janet Woodcock. And the new super compliance office will also have three officewide func... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911824 Tue, 07 Jun 2011 12:06:07 +0100 4911824 http://www.medworm.com/index.php?rid=4872096&cid=t_108521_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fchantix-lawsuits-the-next-greatest-get-rich-quick-scheme-for-smokers%2F2011.05.26 Chantix lawsuits here we come.  I’ve been prescribing Chantix and helping fill out forms for free Chantix for my patients for several years now.  Chantix is one medicine used to help get patients to quit smoking right now.  In fact, I even had a case presentation of a woman I warned to quit smoking for good or face a lifetime of being cross eyed. Does Chantix help to quit smoking? Yes it does.  It helps to take the cravings away in folks who use it.  If you smoke, you should want to quit, based on my discussions with a tobacco farming insider.  If nothing has helped, Chantix might be your last hope.  As a hospitalist, I always offer Chantix therapy as part of my smoking lecture (that I bill out as smoking cessation CPT 99406 or 99407) With the average cost of cigarettes... Better Health blogs http://www.medworm.com/rss/comments.php?id=4872096 Thu, 26 May 2011 16:00:00 +0100 4872096 http://www.medworm.com/index.php?rid=4862922&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWOR8kB8UEnM%2F In response to regulatory demands and mounting litigation, drugmakers have puffed up their product labeling to the point where the verbiage occupies numerous pages and contains a laundry list of possible side effects. Yet all these warnings have a down side, because they may undermine patient adherence and overwhelm docs as they try to find suitable treatments, according to a new study. In fact, the study found that the list of potential side effects averaged 70 per drug, and the 200 most widely prescribed meds averaged 105 possible adverse events, leading to what the researchers labeled (pun intended) overwarning. The study, which analyzed 5,602 labels and was published in The Archives of Internal Medicine, even found one label listing 525 possible side effects. “The idea that lab... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862922 Wed, 25 May 2011 12:03:18 +0100 4862922 http://www.medworm.com/index.php?rid=4862928&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYbxeh9RwSNI%2F While the FDA continues to ponder rules for social media, Facebook is now changing its own rules and will no longer allow drugmakers to disable comments posted on newly created pages. And existing pages will no longer be able to do so as of August 15, according to InTouch Solutions. The move reportedly came by way of email last week: “As you know, Facebook Pages are a free product for organizations, public figures, businesses, and brands to express themselves and have an authentic, engaging, two-way dialog with people on Facebook…We think these policy changes support consistency for the Facebook Pages product and encourage an authentic dialogue between people and businesses on Facebook.” The social media gorilla goes on to acknowledge the changes may cause pharma to &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862928 Tue, 24 May 2011 13:19:52 +0100 4862928 http://www.medworm.com/index.php?rid=4853219&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0YpF1gE-5K8%2F Could data mining medical literature uncover side effects before they cause serious harm to patients? A new study maintains the effort could effectively complement existing methods, such as combing through the FDA’s Adverse Events Reporting database, because prior research suggests that up to 98 percent of searches are irrelevant to side effects and may skew results toward false positive links. To prove the point, two researchers from the Rank think tank developed an algorithm to sift through the PubMed literature and searched for mentions of least one of 38 drugs and 55 side effects. From there, they determined the relevance of the articles and forecast expected rates of adverse events. They would up analyzing 9,133 articles published between 1949 and September 2009, plus others tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853219 Mon, 23 May 2011 14:18:21 +0100 4853219 http://www.medworm.com/index.php?rid=4847960&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F05%2F19%2Fuk-paediatrician-and-msbp-expert-knew-babies-suffered-breathing-problems-and-died-after-vaccination%2F Over the last two years I have seen two documentaries both entitled ‘A Very Dangerous Doctor’. Both featured the work and research of the now discredited Professor David Southall. It has puzzled me how these documentaries failed to mention the crucial evidence of Lisa Blakemore-Brown and instead both chose to focus their attention on the work and evidence of Munchausen by Proxy campaigner and Southall hater Ms Penny Mellor. Ms Blakemore-Brown began to speak out about this incredibly dangerous man back in 1995/1996 long before Penny Mellor had even been heard of. However, instead of the fame and glory that has been lavished on Ms Mellor, Blakemore-Brown has had to endure many attempts to destroy her career, victimization and ridicule. I believe the key reason behind the attempts... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4847960 Thu, 19 May 2011 17:45:11 +0100 4847960 http://www.medworm.com/index.php?rid=4841366&cid=t_108521_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2011%2F05%2Fsuccinylcholine-adverse-effects%2F Succinylcholine is a widely used drug in the operating room and intensive care units for intubation. It is considered a depolarizing muscle relaxant and thus causes fasciculations. It has a rapid onset (40-60 seconds) and is short-acting (10-15 minutes). The adverse effect most classically associated with the use of succinylcholine (aka “sux”) is malignant hyperthermia. A partial list of other adverse effects is below 1. hyperkalemia (increase in serum potassium by 0.5 meq/L) which is exaggerated in patients with burns, myopathies, crush injuries, and denervating injuries 2. arrhythmias – can be either bradycardia from the parasympathetic/muscarinic effect or tachycardia from the sympathetic/nicotinic effect 3. elevated intracranial pressure – use is contraindicated... Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=4841366 Thu, 19 May 2011 06:00:22 +0100 4841366 http://www.medworm.com/index.php?rid=4841989&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTUOHhGEtWzc%2F Adverse event data from the third quarter of 2010 show the risks of serious psychiatric side effects of Chantix, the smoking-cessation drug, were previously underestimated because Pfizer apparently failed to correctly submit hundreds of these episodes to the FDA, according to an analysis by the Institute for Safe Medicine Practices, a non-profit that regulary reviews the FDA adverse event database. Notably, the ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly as suicides within 15 days as required. Instead, the drugmaker apparently coded the suicides as “expected adverse events” among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841989 Wed, 18 May 2011 16:02:13 +0100 4841989 http://www.medworm.com/index.php?rid=4829303&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKx8Hk1e5HcM%2F Shortly after a revelation that drugmakers have not compensated survivors of most volunteers who died during studies run in India, the country’s Drugs Controller General has now issued new draft guidelines for reporting serious adverse events that occur in clinical trials. And there is also a stipulation that all info pertaining to fatalities, including compensation and care, must be reported. A key issue, however, is that drugmakers and contract research organizations are using multiple or different formats and procedures for reporting serious adverse events to the Central Drugs Standard Control Organization, or CDSCO. And so the regulators want all SAEs reported within 14 days of occurrence (as opposed to 15 days elsewhere) and a so-called causality assessment by clinical trial inv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829303 Mon, 16 May 2011 14:43:38 +0100 4829303 http://www.medworm.com/index.php?rid=4803260&cid=t_108521_112_f&fid=34971&url=http%3A%2F%2Fblog.drmalpani.com%2F2011%2F05%2Fhow-can-we-reduce-side-effects-of.html Many medicines are available over the counter ( OTC) . These are usually safe drugs, which have been used for many years . They are effective for common problems; have few side effects; and do not need a doctor's prescription. However, most medicines are still available only with a doctor's prescription. This is because medicines can be powerful , and while they may be very good at treating certain problems, they may also have undesirable side-effects. Experts need to make a decision regarding the risk-benefit ratio of these drugs, so they can select which drugs are so powerful that they can only be dispensed with a doctor's prescription.Medicines form an important tool in the medical armamentarium. However, not all illnesses need medicines, and an increasingly important addition to the me... The Patient's Doctor blogs http://www.medworm.com/rss/comments.php?id=4803260 Mon, 09 May 2011 12:39:00 +0100 4803260 http://www.medworm.com/index.php?rid=4762766&cid=t_108521_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fshould-pharmaceutical-companies-get-involved-in-social-media%2F2011.04.28 Imagine you’re a pharmaceutical company product manager and your specific product helps people with a chronic illness, or a cancer that can be managed by taking a pill or an injectable medicine over many years. You want to be part of the dialogue patients have with each other. You want to be part of the community. Facebook users, and other social media participants, are increasingly forming groups around health conditions, big and small. You want to be there, because, after all, your company has invested hundreds of millions of dollars developing the approved drug and hopes this medicine, and perhaps a successor, will be on the market for a long time. This is an exciting time on the Internet and pharmaceutical product managers want to be part of health discussions. But it is fraught with... Better Health blogs http://www.medworm.com/rss/comments.php?id=4762766 Thu, 28 Apr 2011 21:00:44 +0100 4762766 http://www.medworm.com/index.php?rid=4758702&cid=t_108521_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F04%2F27%2Fjournal-of-the-american-medical-association-2011-vol-305-no-13%2F This article is a case-cohort study examining the association of maximum prescribed daily opioid dose and dosing schedule (“as needed,” regularly scheduled, or both) with risk of opioid overdose death among patients with cancer, chronic pain, acute pain, and substance use disorders. The study concludes that among patients receiving opioid prescriptions for pain, higher opioid doses were associated with increased risk of opioid overdose death. An NHS Athens password is required to access this article online, alternatively contact the Library for a copy. Filed under: Athens Password, Current Awareness, E-Journals, Journals Tagged: Adolescent, Adverse, Analgesia, Drug Prescriptions, Drug Reaction, Hydrocone, Methadone, Mortality, Opioid, Opioid-Related Disorders, Overdose, Pain, Patient S... Fade Library blogs http://www.medworm.com/rss/comments.php?id=4758702 Wed, 27 Apr 2011 13:50:06 +0100 4758702 http://www.medworm.com/index.php?rid=4758709&cid=t_108521_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F04%2F27%2Fjournal-of-the-american-medical-association-2011-vol-305-no-5%2F The objective of this study is to perform a systematic review and meta-analysis of published randomised controlled trials (RCTs) to determine the overall risk of fatal adverse effects (FAEs) associated with bevacizumab, an angiogenesis inhibitor, used in conjunction with chemotherapy. The article concludes that in a meta-analysis of RCTs, bevacizumab in combination with chemotherapy or biological therapy, compared with chemotherapy alone, was associated with increased treatment-related mortality. An NHS Athens password is required to access this article online, alternatively contact the Library for a copy of this article Filed under: Athens Password, Current Awareness, E-Journals, Journals Tagged: Bevacizumab, Cancer, Drug Therapy, Fatal Adverse Effects, Randomised Controlled Trials (Sourc... Fade Library blogs http://www.medworm.com/rss/comments.php?id=4758709 Wed, 27 Apr 2011 10:26:16 +0100 4758709 http://www.medworm.com/index.php?rid=4734608&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Fdid-boehringer-mishandle-this-adverse.html I follow many pharmaceutical companies (and employees of pharma companies; eg, these people) on Twitter. @BoehringerUS is one of them. To keep track of these accounts, I cross-post the tweets to this Pharma Marketing Forum (News Direct from the Pharmaceutical Industry), which automatically sends me a daily email message telling me what's been posted there. It's a good way for me to filter through all the tweets from the over 2,500 people I follow on Twitter.Today, I received notice of the following tweet from @BoehringerUS:@professorbunbun Please call Boehringer Ingelheim @ 800-542-6257 option 4 to report adverse events or product complaints.I traced back the Tweet timeline of @professorbunbun -- "Meredith: Just a girl trying to aclimate to the 21st century corporate world after three year... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4734608 Thu, 21 Apr 2011 13:03:00 +0100 4734608 http://www.medworm.com/index.php?rid=4684326&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F04%2F05%2Fexperts-recommend-delaying-breastfeeding-until-vaccinations-have-taken-effect%2F Just when we thought the world could not get any more insane, it does! News came in today of a study entitled ‘Inhibitory Effect of Breast Milk on Infectivity of Live Oral Rotavirus Vaccines’ advising nursing mothers to delay breast-feeding until after vaccinations. According to the authors this is because breastfeeding lowers the vaccines efficiency!!! A paper outlining the study was written by Sung-Sil Moon, PhD, Yuhuan Wang, MS, Andi L. Shane, MD, MPH, MSc, Trang Nguyen, PhD, Pratima Ray, PhD,§ Penelope Dennehy, MD, Luck Ju Baek, PhD, Umesh Parashar, MB BS, MPH,Roger I. Glass, MD, PhD, and Baoming Jiang, DVM, PhD. This long list of experts were from the National Centres for Immunization and Respiratory Disease, Centres for Disease Control and Prevention, Atlanta, GA; Divisi... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4684326 Wed, 06 Apr 2011 05:24:46 +0100 4684326 http://www.medworm.com/index.php?rid=4664183&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F04%2F01%2Fmother-jailed-for-taking-vaccine-damaged-daughter-off-the-drug-risperdal%2F A mother from Detroit was jailed this week for trying to protect herself and her daughter from the police and the CPS. Maryanne Godboldo’s problems began when her daughter aged 13 was given mandatory vaccinations. The shots were given to her daughter to enable her to begin public school. Shortly after the vaccines, Ms Godboldo noticed a sudden change in daughters behaviour. Her daughter became easily irritated, suffering severe mood swings with episodes of facial grimacing. Worried about her daughters strange and ‘uncharacteristic behaviour’ she asked the ‘The Children’s Centre’ for help. The centre recommended that her daughter took the controversial anti psychotic drug Risperdal. Instead of improving her daughters behaviour however, the drug made her a... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4664183 Fri, 01 Apr 2011 07:50:34 +0100 4664183 http://www.medworm.com/index.php?rid=4658414&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F03%2F30%2Fantioxidants-and-your-health%2F Antioxidants are good for your health. Or at least that is a popular claim. An antioxidant is any molecule that slows down or prevents oxidation reactions.  Originally, oxidation reactions were defined as chemical reactions with oxygen.  More recently, oxidation reactions have been described as reactions in which an atom or molecule loses an electron. Oxidation is a natural part of life.  Excessively high antioxidant levels are detrimental to health. Some people have suggested that oxidation reactions contribute to heart disease, declines in cognitive abilities, and cancer. “Vitamin C, vitamin E, and beta-carotene have been shown to be antioxidants in a test tube, and it is often claimed that they and many other substances are able to function as antioxidants in the body. However, wh... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4658414 Wed, 30 Mar 2011 15:20:01 +0100 4658414 http://www.medworm.com/index.php?rid=4636656&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F03%2Fadverse-event-reporting-pharma-puts.html By now you should have heard that the Supreme Court recently ruled that investors can sue pharmaceutical companies for failing to disclose reports of adverse events even if the evidence is not "statistically significant" (see "Supreme Court Allows Investors to Sue Pharmacos Over AE Reporting Lapses").In a brief to the court, PhRMA (the US pharmaceutical trade association) said "A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event" (the brief is attached to the post cited above).But what is "statistically significant?" According to PhRMA, "The statistical significance standard requires disclosure only once a correlation between an adverse event and the subject ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4636656 Fri, 25 Mar 2011 12:32:00 +0100 4636656 http://www.medworm.com/index.php?rid=4627021&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNOJeZsg0BdM%2F After months of anticipation, the US Supreme Court yesterday ruled Matrixx Initiatives was incorrect to insist that only statistically significant adverse events are required to be reported to shareholders, and allowed investors to proceed with a long-simmering securities fraud claim. The move has significance for drugmakers and biotechs, which filed briefs supporting Matrixx over concerns adverse event disclosures can be easily misinterpreted and lead to more shareholder lawsuits. Here’s the background: Matrixx Initiatives was sued for allegedly concealing side effect reports that its Zicam over-the-counter cold med caused people to lose their sense of smell, known as anosmia. By withholding the reports, shareholders argued Matrixx unfairly boosted the value of its stock. The Zicam ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627021 Wed, 23 Mar 2011 12:07:16 +0100 4627021 http://www.medworm.com/index.php?rid=4512396&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F02%2F23%2Fdoctors-in-uk-warned-after-a-catalogue-of-vaccine-mix-ups%2F Doctors across the UK have come under immense criticism after a survey revealed a catalogue of vaccine blunders. The Medical Defence Unit (MDU), who defends doctors accused of medical malpractice, carried out the survey.  The results revealed that family doctors had been involved in vaccination blunders affecting 98 children and 10 adults over the last five years. These involved patients being given the wrong vaccine, the wrong dose of vaccine or were vaccinated without consent. Amazingly, these errors included babies being administered the MMR shot ‘seven months’ before they should have been. In some instances children were given a meningitis shot when they should have been given the MMR. Dawn Boyall speaking on behalf of the MDU had this to say to the Guardian 21st February ... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4512396 Wed, 23 Feb 2011 15:49:38 +0100 4512396 http://www.medworm.com/index.php?rid=4512395&cid=t_108521_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcoronary-stent-thrombosis-and-your-body-clock%2F2011.02.23 Add coronary stent thrombosis to the list of cardiac events influenced by circadian rhythms, with more events occurring during the early morning hours and in a summertime window of late July and early August. Coronary stent thrombosis joins several other adverse cardiac events that also follow a circadian pattern, such as stroke, unstable angina pectoris, acute myocardial infarction and sudden cardiac death, according to researcher published in JACC: Cardiovascular Interventions. Most studies that addressed circadian variations in cardiovascular disease were done before the advent of stents, so, researcher from Mayo Clinic-Rochester conducted a retrospective analysis of medical records and the clinic’s registry, finding 124 patients who presented with coronary stent thrombosis betwee... Better Health blogs http://www.medworm.com/rss/comments.php?id=4512395 Wed, 23 Feb 2011 14:00:00 +0100 4512395 http://www.medworm.com/index.php?rid=4507579&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVDH6IuJdeJY%2F You read it here first. In a harsh warning letter, the FDA has reprimanded Sanofi-Aventis for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill, and also did not report post-marketing studies or completed, unpublished clinical trials in NDA annual reports. The seven-page missive, which was dated January 28, comes after the agency reviewed Sanofi paperwork last May. And a separate letter dated February 9 notes that a Sanofi plant in Germany has problems with contamination. When it came to reporting adverse events, however, some reporting delays stretched back as far as 2007 - there was a delay of 896 days in reporting side effects associated with the Glybur... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507579 Tue, 22 Feb 2011 15:42:33 +0100 4507579 http://www.medworm.com/index.php?rid=4464455&cid=t_108521_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2011%2F02%2F11%2Fquality-and-safety-in-health-care-2009-vol-18-no-1%2F This article reviews the impact of such errors and how this compromises patient care. (Print subscription held at Fade Library) Filed under: Health and Safety, Uncategorized Tagged: Adverse Drug Events, Errors (Source: Fade Library) Fade Library blogs http://www.medworm.com/rss/comments.php?id=4464455 Fri, 11 Feb 2011 14:16:36 +0100 4464455 http://www.medworm.com/index.php?rid=4414548&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2011%2F01%2F30%2F5-steps-to-a-more-resilient-you%2F Resiliency is what makes some people able to bounce back after a particularly traumatic or difficult time or stressor in one’s life, while others fall apart. It is a component of positive psychology, in that researchers try and figure out what makes resilient people different than others. And then seeks to help others learn some simple skills that may be able to help build resiliency in one’s own life. There are no secret short-cuts to building greater resilience in your life. Most skills you can learn to help build resiliency are things that are going to take lots of time and lots of practice. Practice is one of the things people often forget when it comes to changing one’s behavior or one’s life. You didn’t become this way overnight. It took years — a... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4414548 Sun, 30 Jan 2011 11:40:39 +0100 4414548 http://www.medworm.com/index.php?rid=4337878&cid=t_108521_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fcurious-case-of-pfizers-asbestos-claims.html Here is a very strange and long-running story that raises some questions about how health care organizations are lead, but seems to have bee covered only in the business press.Pfizer Goes Into the Asbestos Business (in 1968), Faced Hundreds of Thousands of Lawsuits (in the 1980s), Promised to Settle (in 2004)Here is the background, per a 2004 report by the Associated Press, per Fox News:Pfizer Inc. (PFE) Friday said it has agreed to pay $430 million to settle all lawsuits against it alleging injury from insulation products made by a subsidiary.Pfizer and its Quigley Co. subsidiary were named, along with several other defendants, in 171,611 lawsuits claiming personal injury caused by exposure to asbestos, silica or mixed dust.Pfizer acquired Quigley Co. in 1968. It sold some products contai... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4337878 Tue, 11 Jan 2011 17:00:00 +0100 4337878 http://www.medworm.com/index.php?rid=4331234&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1Fdv37mljqA%2F Should drugmakers disclose all adverse event reports that may not show statistically significant evidence that a side effect is actually caused by a specific drug? The issue is now before the US Supreme Court involving a case brought by investors against Matrixx Initiatives, which was sued for allegedly concealing side effect reports that its Zicam over-the-counter cold med caused people to lose their sense of smell, known as anosmia (back story). And in oral arguments yesterday, the case made by the lawyer for Matrixx may not have passed the smell test after he insisted Matrixx did not commit fraud when it failed to disclose cases in which Zicam patients reportedly lost their sense of smell. Since drugmakers receive real or hearsay adverse event reports almost every day, Jon Hacker mainta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331234 Tue, 11 Jan 2011 16:06:13 +0100 4331234 http://www.medworm.com/index.php?rid=4314010&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F01%2F05%2Fwill-there-be-more-chronically-ill-and-developmentally-challenged-children-in-pennsylvania%2F Back on May 28, 2010 the Commonwealth of Pennsylvania made changes to its immunization code to be effective August 1, 2011.  What children in Pennsylvania will be required to have in vaccinations in order to attend school is taken directly from the code: (http://www.pacode.com/secure…) 23.83. Immunization requirements. (a)  Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school. Each school director, superintendent, principal, or other person in charge of a public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, and special education and home education programs, cyber and charter schools, shall ascertain that a child has been immunized in ac... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4314010 Wed, 05 Jan 2011 14:34:50 +0100 4314010 http://www.medworm.com/index.php?rid=4241800&cid=t_108521_113_f&fid=39278&url=http%3A%2F%2Fblogsite.mdbuyline.com%2F%3Fp%3D113 Each year, adverse drug events cost an estimated $2 billion a year to treat.  So, how can hospitals achieve the right medication, right dose, right patient, right time, and right route?  According to the Agency for Healthcare Research and Quality, barcoding technology may be the answer.  Over the last few months, I’ve interviewed a long list of hospital CFOs with the goal of determining how they prioritize their capital spending.  Several years ago when I made the same series of interviews, ROI was the determining factor.  Now, as summed up by Debbie Schimerowski, CFO at Provena Covenant Medical Center, Urbana, IL, “Which project takes precedence depends on multiple factors.  Like a lot of hospitals, we have many assets that are at the end of their life cycle right now because mo... MD Buyline blogs http://www.medworm.com/rss/comments.php?id=4241800 Wed, 08 Dec 2010 14:17:28 +0100 4241800 http://www.medworm.com/index.php?rid=4214185&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D2163 The safety of newly marketed drugs is always provisional, based on the relatively limited population the drugs are used in prior to marketing. The number of subjects who take a drug in clinical trials is large enough to detect efficacy, but too small to detect rare, but serious, adverse events. In addition, the patients are [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=4214185 Tue, 30 Nov 2010 09:43:21 +0100 4214185 http://www.medworm.com/index.php?rid=4175764&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F11%2F17%2Ffda-approves-vyvanse-for-teens%2F In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo [...]. All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). [...] All Vyvanse dose groups were superior to placebo in the primary efficacy outcome. The safety of Vyvanse was also evaluated during the study. The most frequently occurring treatment-emergent adverse events reported in patients treated with Vyvanse were: decreased appetite, insomnia, and weight decrease. Saf... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4175764 Wed, 17 Nov 2010 22:35:05 +0100 4175764 http://www.medworm.com/index.php?rid=4121859&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F10%2F30%2Fletter-alerts-obama-to-dangers-of-hpv-vaccines%2F In an extraordinary move to prevent further HPV vaccine casualties, Marian Greene the Chairwomen and Co-Founder of the campaign and action group Truth about Gardasil (http://truthaboutgardasil.org/), has written an open letter to President Obama.  Her letter urges the President to take time to research the HPV vaccines Gardasil and Cervarix and to read what is happening to the innocent young men and women of America. She opens her letter by saying: “We come to you now to beg for your help. The lives of an entire generation of young women and now, men, are hanging in the balance.” Greene strengthens her plea by alerting the President to a staggering 20101 reports of injury and 84 deaths; highlighting the case of a forty day old baby who died after being exposed to Gardasil through the ... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4121859 Sat, 30 Oct 2010 15:01:49 +0100 4121859 http://www.medworm.com/index.php?rid=4118939&cid=t_108521_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F10%2F26%2Fmultiple-deaths-linked-to-childhood-vaccines%2F On 24th October 2010, the Sunday Times reported new evidence suggesting that forty children have died over the past seven years following a routine childhood vaccination. This was revealed after the Sunday Times sent a Freedom of Information (FOI) data request to the Medicines and Healthcare products Regulatory Authority (MHRA). The FOI data revealed that childhood vaccinations are suspected to have caused forty deaths, of leaving two young children with brain injuries and causing more than 1,500 other neurological reactions, including 11 cases of inflammation of the brain, 13 cases of epilepsy and a coma. In the article ’40 deaths linked to child vaccines over seven years’ by Sarah-Kate Templeton (http://www.thesundaytimes.co.uk/sto/news…), Templeton reported that when a... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4118939 Tue, 26 Oct 2010 16:19:22 +0100 4118939 http://www.medworm.com/index.php?rid=4040789&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrCxBap_Axoc%2F How is this for a difference of opinion? During an inspection of Actelion Pharmaceuticals offices in the summer of 2009, the FDA found the drugmaker was repeatedly failing to follow proper procedures for reporting adverse events and, as a result, about 3,500 patient deaths were never filed with the agency. Yes, about 3,500. The reports referred to two different drugs - Tracleer and Ventavis – which are approved to treat various forms of pulmonary arterial hypertension. As the agency notes, however, this is a serious condition that often results in death. And so the FDA stresses there is no conclusion or implication that patient deaths not reported properly would ultimately be connected to use of the drugs. Just the same, federal law requires that deaths must be reported to the FDA within... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4040789 Thu, 07 Oct 2010 12:26:47 +0100 4040789 http://www.medworm.com/index.php?rid=4022951&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D2130 Just a short note. A couple of years ago there was a great deal of fuss about paracetamol and a possible link with asthma in children [Lancet]. The study reported on was a large retrospective study (205 487 children) involving surveying parents about their children’s previous paracetamol use and symptoms of asthma. There is an [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=4022951 Fri, 01 Oct 2010 15:39:20 +0100 4022951 http://www.medworm.com/index.php?rid=4022900&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FqCYT1eaGZXs%2F By Michael F. CannonFirst, a dozen insurers said they would stop writing child-only health insurance policies.  Now, according to the Wall Street Journal: By forcing the exit of Principal Financial Group — which ran a profitable, $1.6 billion health insurance business — ObamaCare has now left 840,000 Americans to find another source of coverage. According to The New York Times, other insurers may soon follow: More insurers are likely to follow Principal’s lead, especially as they try to meet the new rules that require plans to spend at least 80 cents of every dollar they collect in premiums on the welfare of their customers… “It’s just going to drive the little guys out,” said Robert Laszewski, a health policy consultant in Alexandria, Va. Smaller players like ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4022900 Fri, 01 Oct 2010 14:09:44 +0100 4022900 http://www.medworm.com/index.php?rid=4013550&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDsZNX7-Tasc%2F Responding to years of complaints that safety risks are being downplayed or ignored during the drug development process, the FDA has just issued a final rule for reporting safety information that crops up during clinical trials. This new rule requires certain safety info, which was was not required to be reported in the past, to be submitted within 15 days of when a drugmaker becomes aware of an issue. To wit, drugmakers must report findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions that occur at a rate higher than expected and serious adverse events from bioavailability studies which determine what percentage and at what rate a drug is absorbed by the bloodstream as well as bioequivalence studies tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013550 Tue, 28 Sep 2010 14:58:35 +0100 4013550 http://www.medworm.com/index.php?rid=4013152&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FtcY8-zHMO2w%2F By Michael F. CannonWith the addition of a poll by George Washington University and Politico — completed the day before ObamaCare started sending health insurance premiums higher, making coverage less accessible for children, and destroying health insurance innovations — Pollster.com shows that among likely voters, ObamaCare now suffers a 10-point popularity gap: (As I’ve noted before, Pollster.com’s local-regression trend estimate will head off in a direction different from public opinion if the latest poll is a fluke.  But these trajectories are consistent with Pollster.com’s trend estimates for polls surveying registered voters and all adults, which incorporate many more data points.) Also worth noting: ObamaCare has never enjoyed the support of a major... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4013152 Mon, 27 Sep 2010 21:38:52 +0100 4013152 http://www.medworm.com/index.php?rid=4003238&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FtcY8-zHMO2w%2F By Michael F. CannonWith the addition of a poll by George Washington University and Politico — completed the day before ObamaCare started sending health insurance premiums higher, making coverage less accessible for children, and destroying health insurance innovations — Pollster.com shows that among likely voters, ObamaCare now suffers a 10-point popularity gap: (As I’ve noted before, Pollster.com’s local-regression trend estimate will head off in a direction different from public opinion if the latest poll is a fluke.  But these trajectories are consistent with Pollster.com’s trend estimates for polls surveying registered voters and all adults, which incorporate many more data points.) Also worth noting: ObamaCare has never enjoyed the support of a major... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4003238 Mon, 27 Sep 2010 21:38:52 +0100 4003238 http://www.medworm.com/index.php?rid=3999292&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9LNFS_XlUFw%2F An ongoing number of shortages of prescription meds is wreaking havoc among health care practitioners who work in hospitals and patients are at risk, yet little or no information is available from the FDA or drugmakers, according to a new survey. To wit, 35 percent say their facility experienced an error that could have led to patient harm during the past year thanks to a shortage. About one in four reported errors that reached patients and one in five reported adverse patient outcomes. Compounding matters, the extent of the problem may actually be greater than reported, because errors and adverse outcomes are difficult to quantify due to voluntary reporting methods. Consequently, the survey respondents said the frequency of adverse events due to shortages is likely to be much higher. The ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999292 Fri, 24 Sep 2010 12:38:00 +0100 3999292 http://www.medworm.com/index.php?rid=3994336&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F09%2Fdid-j-troll-social-media-sites-to.html A Blog is a very useful archive of information that over time may reveal connections between seemingly unrelated events. Take the Johnson and Johnson (JNJ) "phantom recall" of Motrin that I and many other bloggers have written about (see, for example, "Parallels Between BP and J and J" and "J and J ‘Phantom Recall’ Shows Motrin Troubles Go Back to 2008"). By now everyone in the US should know about this -- the story has been on the major news networks (see "Are Secret Drug Recalls Common?") and Ed Silverman has reviewed it admirably on Pharmalot (see "Johnson & Johnson Tap Dances Around Congress").But when I was searching Pharma Marketing Blog for another story (ie, J&J's new scandal about the safety of the Ortho Evra birth control patch: "Did J and J Hide birth control patch r... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3994336 Thu, 23 Sep 2010 12:02:00 +0100 3994336 http://www.medworm.com/index.php?rid=3993884&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FaPLQbHBbzV8%2F By Michael F. CannonThis is what happens when government price controls limit insurance companies’ ability to set premiums according to risk: Note that this adverse-selection death spiral happened before ObamaCare‘s price controls on child-only coverage even took effect.  (Of course, President Obama never calls them price controls.  He calls them “consumer protections.”  Some protection.) ObamaCare supporters are in full-blown denial: “We’re just days away from a new era when insurance companies must stop denying coverage to kids just because they are sick, and now some of the biggest changed their minds,” Ethan Rome, executive director of Health Care for America Now, an advocacy group, said in a statement. “[It] is immoral, and to blame ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3993884 Tue, 21 Sep 2010 18:09:40 +0100 3993884 http://www.medworm.com/index.php?rid=3993886&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F3TlU4KCMCaY%2F By Michael F. CannonUSA Today and Politico Pulse report that ObamaCare has prompted BlueCross BlueShield of North Carolina to rebate $156 million to its customers in the individual market.  This may seem like good news.  It’s actually bad news, particularly for BCBS’s sickest customers. Pre-ObamaCare, BCBS’s customers – whether healthy or sick – had coverage with an insurer that had already pre-funded their future medical needs. Competition protected them from BCBS skimping on care: if BCBS got a reputation for skimping, it would have a hard time enrolling new customers. Post-ObamaCare, BCBS no longer needs that pile of cash, so they’re returning it to their customers. That hurts sick enrollees because BCBS is doling it out to all enrollees – not just the sick e... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3993886 Tue, 21 Sep 2010 15:35:30 +0100 3993886 http://www.medworm.com/index.php?rid=3934499&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D2102 (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=3934499 Sat, 04 Sep 2010 10:24:50 +0100 3934499 http://www.medworm.com/index.php?rid=3921074&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG9QmStpWc40%2F Should drugmakers disclose all adverse event reports that may not show statistically significant evidence that a side effect is actually caused by a specific drug? The issue is now before the US Supreme Court involving a case brought by investors against Matrixx Initiatives, which was sued for allegedly concealing side effect reports that its Zicam cold med caused people to lose their sense of smell, known as anosmia. Not surprisingly, BayBio, a trade group representing a goodly number of life sciences companies, has waded into the fracas with an amicus curiae, or friend-of-the-court brief, decrying the notion that drugmakers and biotechs should be forced to disclose adverse event reports that companies believe are irrelevant to the performance of their meds. “Laws requiring disclos... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921074 Tue, 31 Aug 2010 13:09:05 +0100 3921074 http://www.medworm.com/index.php?rid=3895925&cid=t_108521_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2F1yn5of4npC0%2Fmore-on-using-singulair-treatment-for.html Previously I reviewed the literature on the off-label use of zafirlukast (Accolate) and montelukast (Singulair) for the treatment of capsular contracture.  The recent issue (May/June 2010) of the Aesthetic Surgery Journal has an article (full reference below) on the use of Singulair for capsular contracture (CC). Huang and Handel’s article reviews the literature, noting some articles I missed.  Their study is a small (17 patients, 4 with bilateral CC for a total of 21breasts treated with Baker’s Grade II or greater CC).  All of their patients were informed of possible risks associated with the off-label application of Singulair before being prescribed 10 mg of Singulair for 90 days and instructed to massage their breasts twice daily. Unlike Accolate, the adverse event ... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=3895925 Mon, 23 Aug 2010 11:10:00 +0100 3895925 http://www.medworm.com/index.php?rid=3862189&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXaZa343693Q%2F Why do some people volunteer for clinical trials? Are they aware of the risks? Are they treated properly? What kind of follow up should take place? These are among the issues that Roberto Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York and a PhD in anthropology, explored in a new book, ‘The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects.’ He would like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws. And he favors the creation of a national registry of Phase 1-trial participants, which prevent people from participating in too many trials and help researchers identify long-term adverse effects associated with certain trials... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3862189 Thu, 12 Aug 2010 13:59:23 +0100 3862189 http://www.medworm.com/index.php?rid=3733308&cid=t_108521_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F211%2Fbest-wrinkle-cream-ingredients-to-look-for-and-others-to-stay-away-from%2F What will you find in the best eye wrinkle cream?  Which ingredients should be avoided?  You’ll find the answers here. If you read a few online reviews, you will see that some people have terrible adverse reactions to these products.  The reactions include extreme redness, swelling, itching and irritated eyes.  Those reactions can be avoided if you avoid certain ingredients used in wrinkle creams. Paraffin wax is one to avoid.  I’m not sure why cosmetic companies include this ingredient in serums to be used around the eyes.  It is too thick and hard to apply.  But, it is included in some of the big brand named products. Artificial preservatives and added fragrances should be avoided in all cases, regardless of where the product is to be applied.  They are the most common causes... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3733308 Wed, 07 Jul 2010 12:10:25 +0100 3733308 http://www.medworm.com/index.php?rid=3721981&cid=t_108521_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F191%2Fnatural-advantage-skin-care-products-review%2F Natural Advantage skin care products are available direct from the manufacturer and through numerous retailers.  Are they the right choice for fighting wrinkles and other signs of aging?  Let’s take a look at the ingredients. The daily moisturizer has an SPF rating of 15.  It contains alpha hydroxy acids. Alpha hydroxy acids have been included in anti-aging products for years.  There’s nothing “new” about them. While they may be beneficial in some ways, they can also cause irritation.  There are more advanced ingredients on the market. The SPF rating of 15 is something that has been recommended for protecting against sun damage.  There are many controversies surrounding regular sunscreen use.  You will have to decide if it is the right choice for you.  There are alternative... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3721981 Fri, 02 Jul 2010 11:18:31 +0100 3721981 http://www.medworm.com/index.php?rid=3714162&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FJrToVIiLFjE%2F By Michael F. CannonThe Massachusetts health care law that Gov. Mitt Romney signed in 2006, and the nearly identical federal law that President Obama signed this year, create perverse incentives that are causing health insurance costs to rise and could eventually cause health insurance markets to collapse. A report released yesterday by the Massachusetts Division of Insurance shows that process is well underway. Massachusetts requires health insurance companies to sell to all applicants, and imposes price controls that require insurers to charge all applicants the same premium, regardless of their health status.  ObamaCare would do the same. Those price controls have two principal effects on healthy people.  First, they increase the premiums that insurers charge healthy people (the addit... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3714162 Wed, 30 Jun 2010 17:15:27 +0100 3714162 http://www.medworm.com/index.php?rid=3662922&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1gmHvGi8x14%2F The failure to disclose adverse events can have all sorts of repercussions. Doctors and patents get alarmed. Regulators get upset (see what the FDA told Pfizer last month). And shareholders get steamed. Now, the US Supreme Court will review a case to determine whether drugmakers must disclose all adverse event reports that may not show statistically significant evidence that a side effect is actually caused by a specific drug. The case was brought by investors against Matrixx Initiatives, which was sued for allegedly concealing side effect reports that its Zicam cold med caused people to lose their sense of smell, known as anosmia. For its part, Matrixx is challenging an appeals court ruling last fall that reinstated a 2004 shareholder lawsuit alleging the company received at least a dozen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3662922 Tue, 15 Jun 2010 16:00:15 +0100 3662922 http://www.medworm.com/index.php?rid=3648799&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSb_5e1eTnn0%2F In a stinging, 12-page letter, the FDA has scolded Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra, and neglecting to tell the agency about missing samples, some of which may have been stolen, although the FDA wasn’t always informed promptly. The May 26 warning was issued in response to a 6-week audit of Pfizer’s New York headquarters last summer. The delays in reporting adverse events go as far back as 2004 - and accelerated more recently. About 4 percent of 80,560 reports weren’t filed with the FDA on time between March 2006 and December 2008 compared with 9 percent from December 2008 to June 2009. For instance, Pfizer failed to report cases concerning V... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648799 Thu, 10 Jun 2010 12:47:54 +0100 3648799 http://www.medworm.com/index.php?rid=3610522&cid=t_108521_155_f&fid=38412&url=http%3A%2F%2Fpathlabmed.typepad.com%2Fsurgical_pathology_and_la%2F2010%2F05%2Faabb-smartbrief-article-from-mark-poolriversidehealthcarenet.html One less thing to worry less about regarding transfusion-transmitted infections.   Transfusion: Prevalence of human herpesvirus 8 in healthy blood donors is low. The first systematic study of human herpesvirus 8 in U.S. blood donors found that the prevalence of detectable genomes of HHV-8, which causes Kaposi's sarcoma, is very low in healthy donors. According to the study, featured in the May issue of Transfusion, a sensitive and quantitative real-time polymerase chain reaction assay was used to detect HHV-8 DNA from purified CD19+ B lymphocytes from 962 randomly selected U.S. whole-blood donors.Read the abstract and editorial. (Source: The Daily Sign-Out) The Daily Sign-Out blogs http://www.medworm.com/rss/comments.php?id=3610522 Fri, 28 May 2010 18:13:12 +0100 3610522 http://www.medworm.com/index.php?rid=3592197&cid=t_108521_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FOdetYO-VnLg%2F By Michael F. CannonJohn Goodman is correct that ObamaCare’s individual mandate — and Kathleen Sebelius’s power to make the mandate more burdensome at whim — threaten the continued existence of health savings accounts (HSAs).  But ObamaCare’s price controls are no less a threat. The new law requires insurers to charge enrollees of the same age the same average premium, regardless of health status.  That’s a price control, and it will cause premiums for healthy people to rise dramatically and thus lead to massive adverse selection.  Healthy people will gravitate to less-comprehensive insurance — in particular, HSA-compatible high-deductible plans — where the implicit tax is smaller. As premiums for comprehensive plans spiral upward (ulti... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3592197 Mon, 24 May 2010 13:55:02 +0100 3592197 http://www.medworm.com/index.php?rid=3592427&cid=t_108521_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F85%2Fadvances-in-dermatology-still-badly-needed%2F Scientists have been working to advance dermatology and make changes.  We need change, because the old “tried and true” approaches are ineffective and probably doing more harm to our skin than good. Sometimes it seems that for every scientific conclusion, there is a contradictory one.  An example is found in treating and identifying the causes of acne. Prior to the 1950s, dermatologists agreed that diet played a role in acne.  In particular, they blamed sugary snacks and junk food. Research conducted in the late 1960s and early 1970s proclaimed that there was no connection between diet and acne.  Within the last couple of years, scientists have again demonstrated that there is a connection between the consumption of carbohydrates and the severity of acne.  They were also able to p... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3592427 Mon, 24 May 2010 00:12:50 +0100 3592427 http://www.medworm.com/index.php?rid=3552545&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI42DKu7h6mE%2F The European Medicines Agency (EMEA) recently refused to release documents containing suspected adverse reactions caused by Accutane (which is called Roaccutane in the UK), after a law firm in two years ago Ireland requested info that dated back to 1992. At issue were reports linking the acne drug to suicidal tendencies, a topic that has been the subject of controversy and litigation for years (see here). And so European Ombudsman Nikiforos Diamandouros yesterday vigorously disagreed with the EMEA argument that transparency rules do not apply to these reports. “EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he said in a statement. “Since its work has a direct impact on the health of European citizens, it is of utmost importanc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3552545 Tue, 11 May 2010 12:42:17 +0100 3552545 http://www.medworm.com/index.php?rid=3552577&cid=t_108521_155_f&fid=38412&url=http%3A%2F%2Fpathlabmed.typepad.com%2Fsurgical_pathology_and_la%2F2010%2F05%2Fcdc-reports-increase-in-hepatocellular-carcinoma.html This report summarizes the results of that analysis, which determined that the average annual incidence rate of HCC for 2001--2006 was 3.0 per 100,000 persons and increased significantly from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an average annual percentage change in incidence rate (APC) of 3.5%.The incidence rate for males (5.0 per 100,000 persons) was approximately three times higher than the rate for females (1.3) (Table 1). The HCC rate for males increased from 4.5 in 2001 to 5.4 in 2006, and the rate for females increased from 1.2 to 1.4 (Figure). During 2001--2006, the APC for males (3.6%) was significantly higher than the APC for females (2.3%).While the highest incidence rate was highest in Asian/Pacific Islanders (7.8 per 100,000 persons), the rate in this... The Daily Sign-Out blogs http://www.medworm.com/rss/comments.php?id=3552577 Mon, 10 May 2010 20:18:47 +0100 3552577 http://www.medworm.com/index.php?rid=3538406&cid=t_108521_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F50%2Fliposuction-replaced-by-mesotherapy-lipodissolve%2F For a long time, liposuction had been the most popular method for contouring the body.  Today it has been largely replaced by mesotherapy probably because it’s less expensive, less painful, less complicated. Mesotherapy is a process in which a cocktail of chemicals, vitamins and minerals is injected into the targeted area. Usually a series of sessions is required but some patients note a decrease in girth even with just one. There may be some bruising after the procedure but this usually disappears in a few days. I haven’t come across any reports of adverse reactions with mesotherapy although many doctors are skeptical about the safety of these drugs. No conclusive studies have been made in order to determine where exactly the fat goes after it dissolves.  Also in question is whether... Skin MD blogs http://www.medworm.com/rss/comments.php?id=3538406 Wed, 05 May 2010 17:37:07 +0100 3538406 http://www.medworm.com/index.php?rid=3511774&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fhow-not-to-solicit-adverse-medical.html My Twitter and real-life pal Fabio Gratton (@skypen) -- Co-founder & Chief Innovation Officer of Ignite Health -- sent out this tweet today:New Web Site Invites Patients To Report on Adverse Medical Events: http://bit.ly/bp7EGx #fdasm #hcsmWhere Fabio tweets, I follow!So I clicked on the link and found this article:The Empowered Patient Coalition and Consumers Union's Safe Patient Project have launched a Web site that invites patients to fill out a 40-question survey about their experiences with an adverse medical event, Modern Healthcare reports.The survey asks respondents to provide details on the incident, such as:* The state where the error occurred;* The type of health care provider involved;* The procedure or treatment associated with the incident;* Factors contributing to the er... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3511774 Wed, 28 Apr 2010 14:09:00 +0100 3511774 http://www.medworm.com/index.php?rid=3487393&cid=t_108521_155_f&fid=38412&url=http%3A%2F%2Fpathlabmed.typepad.com%2Fsurgical_pathology_and_la%2F2010%2F04%2Fstudy-opens-discussion-on-use-of-plasma-from-female-donors---related-stories---aabb-smartbrief.html - Related Stories - AABB SmartBrief.Noted this from my daily AABB SmartBrief.  Transfusion-related acute lung injury (TRALI) has been a stubbornly enigmatic disease entity since being first described in detail about 25 years ago.  Since antibody-associated TRALI (the most common and severe form) has almost exclusively been associated with women donors with a history of pregnancy, many centers have followed a straight-forward policy of excluding all female donors for plasma-rich products (e.g., FFP and apheresis platelets).  The U.K. instituted this policy nationally in 2003.  While in that country saw a decline of 66% in the incidence of "probable" TRALI and associated deaths in the three years following adoption of this policy, the price is exclusion of ... The Daily Sign-Out blogs http://www.medworm.com/rss/comments.php?id=3487393 Mon, 19 Apr 2010 18:50:01 +0100 3487393 http://www.medworm.com/index.php?rid=3463856&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F04%2Fif-patients-know-best-then-patient.html A recent article published in the New York Times caught my attention. The article -- "In Reporting Symptoms, Don’t Patients Know Best?" (find it here) -- suggested that doctors tend to "downgrade symptoms" (ie, adverse effects of drugs) reported to them by their patients because of "wishful thinking" or, worse, because they do not want to document problems they failed to act on for fear of being sued.That being the case, there is little hope that widespread use of electronic medical records will capture useful adverse events that the FDA can analyze. Garbage in, garbage out as they say.Speaking of garbage, the article criticized FDA's MedWatch program that allows doctors and patients to report problems that they think are adverse events from drugs already on the market. "But it’s a pas... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3463856 Tue, 13 Apr 2010 14:09:00 +0100 3463856 http://www.medworm.com/index.php?rid=3453934&cid=t_108521_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FblqJyDzRxYI%2Flipodissolve-too-good-to-be-true.html I have long been skeptical of Lipodissolve claims.  Patients would ask about the injections that dissolve the fat without surgery.  How it worked?  How safe is it?  Do you do it?  Do you know anyone who does? The FDA has finally issued a warning On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products. The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve are safe and effective have an outstanding safety record are su... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=3453934 Thu, 08 Apr 2010 17:01:00 +0100 3453934 http://www.medworm.com/index.php?rid=3411303&cid=t_108521_155_f&fid=38412&url=http%3A%2F%2Fpathlabmed.typepad.com%2Fsurgical_pathology_and_la%2F2010%2F03%2Ffda-reports-fatalities-related-to-transfusion-and-blood-collection-for-2009.html The FDA has released the summary for 2009 of transfused-related fatalities.  Of 74 transfusion-recipient fatality reports, they determined that 44 of the fatalities were transfusion-related, 22 of the fatalities were cases in which transfusion could not be ruled out as the cause of the fatality, and 8 of the fatalities were unrelated to the transfusion.Interestingly, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) accounted for the highest numbers of reported fatalities, followed by non-ABO hemolytic transfusion reactions.  Another finding of note is that there were no reports of fatal microbial infections associated with RBCs, compared to 5 reports in FY2008, which were all due to Babesia infections.A pdf of the report c... The Daily Sign-Out blogs http://www.medworm.com/rss/comments.php?id=3411303 Fri, 26 Mar 2010 19:48:34 +0100 3411303 http://www.medworm.com/index.php?rid=3374373&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fshould-sanofi-aventis-submit-adverse.html Sanofi-Aventis (S-A) submitted 14 pages of comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here)."As part of routine monitoring of online discussions hosted, or with participation, by a company, postings that contain potential adverse event reports should be addressed according to established company policies and procedures for handling and reporting spontaneous adverse event reports according to current FDA regulations," said S-A in its comments. "This includes, when appropriate [my emphasis], to follow-up to obtain the necessary elements needed to report an adverse event."Considering the problems that S-A is experiencing on its VOICE Facebook page with regard to "disgruntled patient" S... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3374373 Wed, 17 Mar 2010 14:19:00 +0100 3374373 http://www.medworm.com/index.php?rid=3322628&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fpatientslikeme-reports-high-rate-of.html  PatientsLikeMe (PLM) -- an online community for people with "life-changing conditions" -- submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here). The most interesting comments are about PLM's experience with adverse events reported by its members. In short, PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample o... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3322628 Tue, 02 Mar 2010 13:30:00 +0100 3322628 http://www.medworm.com/index.php?rid=3307088&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9nnWUAzw8S8%2F In the third quarter of 2009, the number of serious, disabling and fatal adverse drug events reported to the FDA numbered 29,065, compared to 26,809 in the same quarter a year earlier, an 8.4 percent rise, according to the Institute for Safe Medicine Practices. For the first three quarters of 2009 combined, the total number of reports was 8.1 percent higher than in the same period of 2008. Highlights of ISMP’s QuarterWatch report include: More than 1,000 reports of patient deaths were received for GlaxoSmithKline’s Avandia in the first three quarters of 2009, more than any other drug the non-profit monitors. Most deaths were attributed to cardiovascular causes and ISMP says that Glaxo responded by saying “most reports were generated by lawsuits.” In the third quarte... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3307088 Thu, 25 Feb 2010 15:53:47 +0100 3307088 http://www.medworm.com/index.php?rid=3016933&cid=t_108521_139_f&fid=38879&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FVirologyBlog%2F%7E3%2FnP-2UGV1rsc%2F The influenza A (H1N1) 2009 vaccine produced by GlaxoSmithKline has been approved by Canada Health. Here is some information on the vaccine to supplement what I’ve provided about the US counterparts. The Canadian vaccine, called Arepanrix H1N1, is supplied in two parts. One contains inactivated H1N1 influenza virus, and the second consists of AS03 adjuvant (DL-a-tocopherol, squalene, polysorbate 80). Before injection the virus and adjuvant are mixed. The vaccine is provided in 10-dose vials and therefore contains thimerosal. More information on the amounts of these components can be found at the Canada Health website (”Product Information Leaflet Arepanrix™ H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine”). Health Canada approved the vaccine based on limited clinic... virology blog blogs http://www.medworm.com/rss/comments.php?id=3016933 Thu, 22 Oct 2009 21:51:19 +0100 3016933 http://www.medworm.com/index.php?rid=2912531&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqqlqnwpCc2o%2F Amgen fired a project manager for complaining that the pharmaceutical giant underreported “adverse events” involving “every product it markets,” the man claims in a lawsuit filed in Superior Court in Ventura, Ca., Courthouse News reports. Shawn O’Brien says Amgen continues to underreport “post marketing adverse event” data to the FDA and that he was ordered to “stop all work” in 2007 after he found that Amgen’s post-marketing product complaints department was underreporting adverse data for “every product it markets.” O’Brien says he was told not to discuss the issue with anyone, and four weeks later he was fired in a “reduction in force.” He seeks lost wages and punitive damages for wrongful firing, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2912531 Tue, 20 Oct 2009 21:46:57 +0100 2912531 http://www.medworm.com/index.php?rid=2865723&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D2029 I’m presenting a couple of posters at the International Society of Pharmacovigilance Conference this week. One is concerned with possible neuropsychiatric reactions to varenicline, and the other uses the DoTS ADR classification system to analyse reports of angioedema with angiotensin-II receptor antagonists. Further details at the links in the text. (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2865723 Tue, 06 Oct 2009 10:24:22 +0100 2865723 http://www.medworm.com/index.php?rid=2842788&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwhat-techniques-are-used-by-pharma-to.html In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.I am following the results of this survey closely and will provide updates. Here, I focus on this question:How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products??The survey asks respondents to choose one or more of the following responses (and/or add addi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2842788 Tue, 29 Sep 2009 11:44:00 +0100 2842788 http://www.medworm.com/index.php?rid=2839169&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwho-should-be-responsible-for.html The FDA is asking for comments from the public about how it should regulate drug promotion on social network sites (see survey/questionnaire). Several of the questions FDA asks concerns the issue of monitoring, processing, and reporting adverse events that are found on social media sites (see here, here, and here). The pharmaceutical industry is concerned that the floodgates would open if it were responsible for reporting all the adverse events it encounters on social media.If only the FDA would not insist that manufacturers submit Adverse Event Reports (AERs), then all the industry's worries would be over. But how would FDA get this information? What about making physicians responsible for submitting all AERs?That's exactly what Miguel A. Tovar, journalist and author of Blogaceutics Blog ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2839169 Mon, 28 Sep 2009 14:12:00 +0100 2839169 http://www.medworm.com/index.php?rid=2836333&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fhow-is-adverse-event-information-from.html In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.I am following the results of this survey closely and will provide updates. Here, I focus on this question:How is adverse event information from these sources being received, reviewed, and processed?The survey asks respondents to choose ONLY one of the following responses (and/or add additional comments):Special group within the company is responsible for receiving, reviewing, and processing AEs (In... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2836333 Sun, 27 Sep 2009 13:38:00 +0100 2836333 http://www.medworm.com/index.php?rid=2834474&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fchallenges-handling-adverse-events.html In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.I am following the results of this survey closely and will provide updates. Here, I focus on this question:What challenges are presented in handling adverse event information from these sources?The survey asks respondents to choose one or more of the following responses (and/or add additional comments):The amount of information from these sources is potentially too vast to be processed economically ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2834474 Sat, 26 Sep 2009 13:26:00 +0100 2834474 http://www.medworm.com/index.php?rid=2832398&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Funcertainties-regarding-reporting.html In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.I am following the results of this survey closely and will provide updates. Here, I focus on this question:What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?The image below shows how respondents answered this question. The image will be updated frequently. See the date stamp on the image for when it was last updated. To ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2832398 Fri, 25 Sep 2009 15:04:00 +0100 2832398 http://www.medworm.com/index.php?rid=2820588&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fare-j-agents-trolling-for-adverse.html The FDA is interested in learning more about how pharmaceutical companies track adverse events on the Internet and have asked the public to submit comments in preparation of the November hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here).Specifically, FDA needs answers to these questions about social media/Internet and AE reporting:How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?How is adverse event information from these sources being received, reviewed, and processed?What challenges are presented in handling adverse event information from these... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2820588 Tue, 22 Sep 2009 14:28:00 +0100 2820588 http://www.medworm.com/index.php?rid=2747959&cid=t_108521_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2Fkw4u6UNY0mM%2Fsuture-allergy-vs-suture-reactivity.html This past week I was once again asked about suture allergy.  It has prompted me to revisit the issue which I have posted about twice now. (photo credit). Sutures by the vary nature of being foreign material will cause a reaction in the tissue.  This tissue reactivity is NOT necessarily a suture allergy. Many factors may contribute to suture reactivity. The length of time the sutures remain.  The longer the sutures are in, the more reactivity occurs. The size of the sutures used.  The larger the caliber of the suture, the more reactivity.  The increase of one suture size results in a 2- to 3-fold increase in tissue reactivity. The type of suture material used.  Synthetic or wire sutures are much less reactive than natural sutures (eg, silk, cotton, ... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=2747959 Mon, 31 Aug 2009 11:01:00 +0100 2747959 http://www.medworm.com/index.php?rid=2688738&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D2010 many of those prescribed Tamiflu are stockpiling it to be sure of having access to the powerful drug Independent 10th of August Doctors should stop giving Tamiflu to children as a routine treatment for swine flu, researchers concluded after finding the drug can cause more harm than good. Independent 11th of August To be fair, no wonder people are [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2688738 Tue, 11 Aug 2009 07:30:10 +0100 2688738 http://www.medworm.com/index.php?rid=2626259&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F07%2Ffda-cannot-track-its-own-review-of.html I don't know whether to laugh or cry regarding a Government Accounting Office (GAO) report that said while the number of adverse-event reports - which help the agency track drug and medical-device safety problems - increased during 2004 to 2008, FDA officials couldn't provide data about how many reports it reviewed! (See "GAO: FDA Can't Determine How Much Money It Needs".)I laugh because the pharmaceutical industry's fear of adverse event reports is unfounded! That fear has been the industry's excuse for not transitioning from "interruption" advertising with its one-way monologue from pharma to consumer to "conversation", two-way dialogue, advertising via social media (see, for example, "Finally, a Drug Company Embraces Social Media, AEs Included!"). If the FDA doesn't know if it has revie... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2626259 Tue, 21 Jul 2009 15:16:00 +0100 2626259 http://www.medworm.com/index.php?rid=2513129&cid=t_108521_147_f&fid=38117&url=http%3A%2F%2Fwww.engageinhealth.com%2F2009%2F06%2Ftaking_a_proactive_approach_to.html One of pharma's biggest concerns with social media is adverse event (AE) reporting. But for an AE to be reportable, it must meet the four criteria: 1) an identifiable patient, 2) an identifiable reporter, 3) a suspect drug, and 4) the side effect. Most often online, #1 and #2 aren’t met. Last year, Nielsen even produced a report quantifying this. To handle AE reporting responsibly, companies that have created a presence in a social media property -- such as JnJ's Health YouTube Channel -- monitor their comments before posting in order to route any AEs appropriately. Some properties, like Facebook, don't allow for monitoring of comments before posting to the Wall, so companies may choose to turn off that feature. Not great for engaging with their audience, but it does avoid the risk. ... The Health Engagement Blog blogs http://www.medworm.com/rss/comments.php?id=2513129 Fri, 19 Jun 2009 21:10:13 +0100 2513129 http://www.medworm.com/index.php?rid=2513171&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F06%2Ffinally-drug-company-embraces-social.html Adverse events! Adverse events! Adverse events!How many times have you heard that tiresome phrase from pharmaceutical companies as an excuse for NOT embracing social media marketing?Practically every social media endeavor that drug companies have engaged in has been a traditional one-sided affair: the drug company talks to the visitor, the visitor never talks to the drug company.Even in so-called online "communities" sponsored by drug companies, there is very little community at all. A case in point is the UCB-sponsored Crohn's & Me website, which has been described as a "faux community" (see "Faux Social Marketing: Have Your Cake and Eat It Too!").Crohn's & Me lacks the benefits of open-ended social networking.The excuse, of course, is that onerous FDA adverse-event (AE) reporting... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2513171 Wed, 17 Jun 2009 10:40:00 +0100 2513171 http://www.medworm.com/index.php?rid=2452608&cid=t_108521_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FXbUsbwRKIDE%2Frecent-npr-stories-on-plastic-surgery.html I want to say these two stories were well done (both aired on June 1, 2009).  I was actually interviewed, but not quoted, for the story on fat-grafting.  I pointed Allison Aubry to Dr Scott Spear as her expert.  He is involved in one of the U.S. studies on breast augmentation using fat grafting.  Sculpting the Body with Recycled Fat by Allison Aubry. Doctors Still Unsure Of Long-Term Risks Surgeons like Dr. Scott Spear of Georgetown University Hospital want to know more about the techniques used to transfer fat for breast augmentation. "We're at the beginning of the learning curve," he says. He has initiated a clinical trial to answer some questions about the best way to perform the procedure and whether there are any measurable risks. To date, there are... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=2452608 Wed, 03 Jun 2009 11:01:00 +0100 2452608 http://www.medworm.com/index.php?rid=2441789&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1973 I have a new article in The Pharmaceutical Journal published with a colleague Dr Deborah Layton looking at the neuraminidase inhibitors oseltamivir and zanamivir. Cox A, Layton D. Adverse drug reactions: Neuraminidase inhibitors: widespread use for influenza may reveal more adverse effects. The Pharmaceutical Journal 2009; 282:621-622 The neuraminidase inhibitors (NAIs), oseltamivir (Tamiflu) and zanamivir (Relenza), are [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2441789 Fri, 22 May 2009 18:22:28 +0100 2441789 http://www.medworm.com/index.php?rid=2405247&cid=t_108521_97_f&fid=35606&url=http%3A%2F%2Fwww.theangriestpharmacist.com%2F2009%2F05%2F12%2F1-to-6-of-10-things-your-pharmacist-wont-tell-you%2F BlueTech shared this article with me. I’m going to respond to each point, and I might even add a few at the end. Update (5/14/09@0055): Yahoo! must have seen the amount of hits pouring from my site to the above link and removed the article. (Or perhaps I think too highly of myself and there’s just an error). Fortunately, Google allows nothing to disappear permanently. http://www.smartmoney.com/spending/deals/ten-things-your-pharmacist-wont-tell-you-3937/ (I believe this to be the site of origin anyway. There are some comments on this page that hints at original publication in the Wall Street Journal. I HIGHLY doubt that it ran in the print version, but the website, SmartMoney.com is a part of the WSJ.com “Digital Network.” Wow…. 1. “I’m overworked ... The Angriest Pharmacist blogs http://www.medworm.com/rss/comments.php?id=2405247 Tue, 12 May 2009 06:24:17 +0100 2405247 http://www.medworm.com/index.php?rid=2405463&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1963 The Guardian has an interesting piece on Orwell and the writing of 1984. The information about the treatment of Orwell’s tuberculosis (TB) seems to indicate that he suffered a fairly severe skin hypersensivity reaction to streptomycin. “In 1947 there was no cure for TB - doctors prescribed fresh air and a regular diet - but there [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2405463 Sun, 10 May 2009 23:38:52 +0100 2405463 http://www.medworm.com/index.php?rid=2398818&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F07%2Fsurprise-approval-of-fanapt-makes-stock-go-wild%2F Shares of Vanda Pharmaceuticals, the makers of Fanapt (iloperidone), surged today after the U.S. Food and Drug Administration sprang a surprise drug approval for Fanapt for schizophrenia late yesterday. In afternoon trading today, the stock hit $10.00 a share, over 8 times what the stock was trading just a day earlier. It fell back to trading around $7.54 - $7.95 range at this time. The drug has a better safety profile in clinical trials than other atypical antipsychotics, which some analysts believe will help boost prescriptions when it goes on the market this summer. Of course, the safety profile may be overly optimistic, as it was for other atypical antipsychotics before they hit the market and reality set in (e.g., use on a more diverse population). Certainly the company could’ve... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2398818 Thu, 07 May 2009 19:58:34 +0100 2398818 http://www.medworm.com/index.php?rid=2398748&cid=t_108521_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FqkpzyUYkVNs%2Fbotox-black-box-warning_07.html The U.S. Food and Drug Administration recently announced that safety label changes including a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) will now be required for all botulinum toxin products.  The agency took the action because of two main reasons.  The first one is the potential for serious risks that may occur from the spread of the botulinum toxin beyond the injection site.  The second reason is associated with the lack of interchangeability among the three licensed botulinum toxin products. When the botulinum toxin spreads beyond the area of injection, symptoms similar to botulism may occur.  These symptoms include unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder con... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=2398748 Thu, 07 May 2009 11:01:00 +0100 2398748 http://www.medworm.com/index.php?rid=2382670&cid=t_108521_129_f&fid=36038&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Ftrevis-life-with-multiple-sclerosis-ms%2Flive-from-the-aan-oral-drugs-for-ms%2F All this week, we’ve been blogging live from the American Academy of Neurology’s annual conference in Seattle, Washington.  Today, we take time for a brief look into the future of multiple sclerosis drug treatments. The question I hear from nearly every person living with MS (and one I ask myself often) is, “How long before oral MS drugs are on the market?”  With the announcement of two new studies on such oral therapies, one must assume it will be relatively soon.  Or maybe it would be more politically correct to say that application to the FDA will happen soon.  How long they take to approve the treatments is an unknown factor. Both Clabridine and Fingolimod are oral drugs which are in the concluding stages of Phase III clinical trials.  Both announced results of said studie... Life with MS blogs http://www.medworm.com/rss/comments.php?id=2382670 Fri, 01 May 2009 22:27:00 +0100 2382670 http://www.medworm.com/index.php?rid=2381260&cid=t_108521_87_f&fid=36050&url=http%3A%2F%2Fwww.blisstree.com%2Fbreastfeeding123%2Fadverse-vaccine-reaction%2F My baby is sick. Possibly sick from the vaccine intended to protect her from illness. And I am sick at heart. You see, I took her in for her 9-month well baby visit three days ago. At that time, she received two vaccinations: DTaP and Rotavirus. Those of you really savvy about vaccinations might see the problem already. I didn’t realize it at the time, but the rotavirus vaccine is not recommended after the baby reaches the age of 32 weeks (about 8 months). RotaTeq rotavirus vaccineMy baby was overdue for her third and final dose of RotaTeq. I had put it off because we were on the waiting list for the Hib vaccine, which is in short supply and must be rationed out by pediatricians. In hindsight I realize I should have proceeded on schedule with my daughter’s other vaccinations, a... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=2381260 Fri, 01 May 2009 05:12:48 +0100 2381260 http://www.medworm.com/index.php?rid=2349717&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fwant-to-see-adverse-events-of-drugs-you.html New to me is the site FDAble, which says it is "A fast, simple search engine for all drug and vaccine Adverse Event information reported to the FDA."I entered these search parameters: "Drug Names: viagra OR sildenafil AND Reaction Names: death AND the outcome of the event was DE AND the person reporting the event was MD"I got 140 hits. Is that a lot?I'll leave it up to you to search for yourself and report back to me. (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2349717 Mon, 20 Apr 2009 20:25:00 +0100 2349717 http://www.medworm.com/index.php?rid=2341858&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fnew-fda-data-adverse-event-reporting.html The FDA received nearly half a million (496, 412) adverse event reports (AERs) in 2008, which is nearly a third (32%) more than it received in 2007 (376,902). By comparison, the 2007 number was only 20% higher than the 2006 number.The definition of "adverse event" for both nonprescription drugs and dietary supplements is "any health-related event associated with the use of a [nonprescription or dietary supplement] that is adverse" (see source). This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.The chart below shows AER data from the FDA for the period 1998 through 2008, as updated on April 6, 2009.Click on image for an enlarged view."These data," says FDA, "describe information about the reporter ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2341858 Wed, 15 Apr 2009 13:20:00 +0100 2341858 http://www.medworm.com/index.php?rid=2313667&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1944 On Friday 17th April 2009 you could attend a one day course at Aston University on drug metabolism. Drug metabolism exerts a powerful influence on drug action - from complete failure of a drug’s effectiveness to life-threatening toxicity. This course focuses on the aims, responses and processes of human drug biotransformation systems. As a result, it [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2313667 Mon, 06 Apr 2009 17:12:14 +0100 2313667 http://www.medworm.com/index.php?rid=2284547&cid=t_108521_88_f&fid=38129&url=http%3A%2F%2Fsandnsurf.medbrains.net%2F2009%2F03%2Ftoxicology-conundrum-004%2F You are called by Doctor X working in Osaka, Japan. Doctor X has just assessed a 44 year-old male who thinks he was bitten or stung by something under his house three days ago. The initial discomfort was mild and localized to his right forearm. However the pain traveled up his arm over the next few [...] (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=2284547 Thu, 19 Mar 2009 00:00:06 +0100 2284547 http://www.medworm.com/index.php?rid=2279768&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F03%2Ftit-for-tat-tithe-on-pharma-marketing.html A few weeks ago, Fabio Gratton, Co-founder nd Chief Innovation Officer at Ignite Health and ePharma Pioneer Club™ member, was a guest on my Pharma Marketing Talk live streaming audio/chat show where he enlightened us about "How To Measure Social Network Communications Success" (see PMT Show #69).During that interview, Fabio threw out a half-baked idea idea intended to help pharmaceutical companies effectively use social media networks by limiting the regulatory risks in exchange for setting aside 10% of their resources (online ad spend? total marketing? profits?) to promote general health and well being.The regulatory risk most often cited by the drug company regualtory people is the uncertainty about investigating and reporting adverse events (AEs) their companies receive through commen... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2279768 Tue, 17 Mar 2009 11:56:00 +0100 2279768 http://www.medworm.com/index.php?rid=2270490&cid=t_108521_88_f&fid=38129&url=http%3A%2F%2Fsandnsurf.medbrains.net%2F2009%2F03%2Ftoxicology-conundrum-003%2F A 27 year-old woman felt a sting on the back of the right leg while pulling on her tracksuit pants. She investigated further and discovered a small black spider, with a red-stripe on its back, crawling around  in  her tracksuit pants. A burning itch developed soon after (affecting the back of her right leg) and lasted [...] (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=2270490 Sun, 15 Mar 2009 07:51:53 +0100 2270490 http://www.medworm.com/index.php?rid=2260415&cid=t_108521_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F03%2F10%2Fhigh-dose-stereotactic-body-radiation-therapy-effective-treatment-for-patients-with-low-volume-lung-or-liver-metastases%2F Libby’s H*O*P*E*™ previously reported on potential treatments for “oligometastasis,” which is defined as cancer that spreads to a few distant body sites, on June 23, 2008 and August 17, 2008.  Two related U.S. multi-institutional, phase I/II clinical studies and one Canadian Phase I clinical study reported recently results from an evaluation of the efficacy and [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2260415 Tue, 10 Mar 2009 21:30:22 +0100 2260415 http://www.medworm.com/index.php?rid=2182288&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1901 An important study in the UK looks at the occurance of adverse drug reactions in hospital in-inpatients. It’s a six month study of in-patients at a Liverpool hospital, and can be considered a follow-up on the study on ADRs seen at admission in the BMJ. Over six months, there were a total of 3695 patient episodes [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2182288 Thu, 12 Feb 2009 01:44:37 +0100 2182288 http://www.medworm.com/index.php?rid=2147458&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1890 Here’s an interesting report of a series of vaccine reactions: A group of schoolchildren in Luton were taken to hospital after complaining that they felt unwell following an injection this morning (January 30). Seven students from Year 10 at Icknield High School were taken to the Luton & Dunstable Hospital as they became ill immediately after receiving [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2147458 Fri, 30 Jan 2009 22:05:58 +0100 2147458 http://www.medworm.com/index.php?rid=2094665&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1869 Deborah Layton and I have a brief article in The Pharmaceutical Journal this week on the subject of antispychotics and the evidence for the risk of stroke associated with their use. Layton D, Cox A. Antipsychotics and stroke: the story to date. The Pharmaceutical Journal 2009; 282: 30 You have to register to read it. (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2094665 Sat, 10 Jan 2009 10:06:03 +0100 2094665 http://www.medworm.com/index.php?rid=2094666&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1868 Cox A. Involving patients in reporting adverse drug reactions should be welcomed. The Pharmaceutical Journal 2009; 282: 16-17 Patients are no longer the passive recipients of drug therapy instigated by medical professionals. There is increasing patient engagement in individual decisions about their own drug therapy, public discussions about the provision of high cost drugs in the [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=2094666 Sat, 10 Jan 2009 09:57:50 +0100 2094666 http://www.medworm.com/index.php?rid=2061181&cid=t_108521_93_f&fid=36697&url=http%3A%2F%2Fjeffreyleow.wordpress.com%2F2008%2F12%2F23%2Fcancer-patient-dies-after-or-fire%2F First tweeted abt this here. “sad story. CA pt dies after fire breaks out in OR of National Taiwan Uni Hospital during oesophagectomy. http://tinyurl.com/3ptb3o “ the procedure the taiwan surgeons were performing was probably an Ivor Lewis. my guess. i saw one couple of months back and blogged abt it here. i thought such stuff was only made for the TV shows or movies. after all, it was indeed kind of similar to what happened in one of the episodes of Grey’s Anatomy, where the roof collapsed (due to a leaking roof and a storm) onto a patient who abdomen was open for a laparotomy. dramatically, when that happened, alex karev (resident assisting) threw his body over the open abdomen which was probably the best anyone could do really. he was scrubbed in.  im not sure what... monash medical student blogs http://www.medworm.com/rss/comments.php?id=2061181 Mon, 22 Dec 2008 22:31:35 +0100 2061181 http://www.medworm.com/index.php?rid=2019558&cid=t_108521_88_f&fid=38203&url=http%3A%2F%2Fprecordialthump.medbrains.net%2F2008%2F12%2F06%2Fproblems-in-toxicology-003%2F A 27 year-old woman was pulling on her tracksuit pants when she felt a sting in the back of the right leg. She investigated and discovered a small black spider, with a red-stripe on its back, in the right leg of her tracksuit pants. A burning itch developed in the back of her right leg and lasted about an hour. She then developed pain in the right groin followed by pain in the lower abdomen and then her back. The abdominal and groin pain disappeared but pain developed in both hands, legs and feet some 6 hours after the bite. Sweating had commenced over her right leg first and became generalized, especially profuse over her head and limbs. Eleven hours after the bite… she presents to your ED. This problem is based on Case 19:2 (page 400) in: Sutherland SK and Tibballs J. Australian A... AEQUANIMITAS blogs http://www.medworm.com/rss/comments.php?id=2019558 Sat, 06 Dec 2008 16:35:21 +0100 2019558 http://www.medworm.com/index.php?rid=1901190&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1852 The EMEA’s Committee for Medicinal Products for Human Use (CHMP) have pulled the marketing authorisation for rimonabant (Acomplia) [PDF]. This isn’t much of a surprise. What is interesting in this case is the reasoning, which not only addresses safety concerns, but also concerns about effectiveness in clinical practice (as opposed to clinical trials). Effectiveness, rather [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1901190 Thu, 23 Oct 2008 21:06:21 +0100 1901190 http://www.medworm.com/index.php?rid=1901970&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F428939063%2F The number of serious problems and deaths linked to medications reported to the FDA set a record in the first three months of this year, the Institute for Safe Medication Practices reports. The FDA received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, according to ISMP’s an analysis of federal data dating to 2004. Yearly totals went back to the 1990s. Two drugs accounted for a disproportionately large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer, which refuted the findings. The drug accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1001 new cas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1901970 Wed, 22 Oct 2008 18:21:27 +0100 1901970 http://www.medworm.com/index.php?rid=1865455&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F10%2F09%2Ftms-treatment-for-depression-gains-fda-approval%2F For anyone looking for an alternative to medications or ECT for the treatment of depression, there’s a new FDA-approved option: transcranial magnetic stimulation (TMS). NeuroStar TMS Therapy® is specifically indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. In clinical trials with NeuroStar TMS Therapy, these patients had been treated with a median of 4 medication treatment attempts, one of which achieved criteria for adequate dose and duration. Transcranial magnetic stimulation (TMS) utilizes an electromagnet placed on the scalp that generates magnetic field pulses roughly the strength o... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1865455 Thu, 09 Oct 2008 20:43:05 +0100 1865455 http://www.medworm.com/index.php?rid=1802560&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1838 In times gone by regulatory bodies concerned with drugs were a black box. Decisions were made and conveyed to the public, with little explanation. Other concerns, that were preliminary and yet to be confirmed by further evidence might be delayed. Public engagement with regulators was minimal. For a number of years things have been changing. The [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1802560 Thu, 18 Sep 2008 08:51:46 +0100 1802560 http://www.medworm.com/index.php?rid=1802561&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1842 Capitalism kills. There is no better example of that principle than in China. The most recent example in the news tonight is that of contaminated baby milk. China says it will launch nationwide testing of all dairy products following the deaths of three babies from contaminated milk formula. More than 6,200 babies have fallen ill after drinking [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1802561 Wed, 17 Sep 2008 23:13:30 +0100 1802561 http://www.medworm.com/index.php?rid=1768863&cid=t_108521_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F09%2F05%2Ftwo-psychiatric-drugs-on-fda-watch-list%2F The U.S. Food and Drug Administration (FDA) today released a list of 20 drugs that are on its adverse effect “watch list” — drugs that have potential new serious risks or had new safety information from January to March 2008. The data come from FDA’s Adverse Event Reporting System (AERS) database, its only method for gathering safety and adverse effects about drugs approved for prescribing in the U.S. Adverse events are voluntarily reported by physicians who prescribe the medications. Two psychiatric medications made the list — Duloxetine (Cymbalta) for a serious risk of urinary retention, and Quetiapine (Seroquel) for overdose due to sample pack labeling confusion. This is the FDA’s first new public information alert system in years, identifying poten... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1768863 Fri, 05 Sep 2008 20:57:53 +0100 1768863 http://www.medworm.com/index.php?rid=1770728&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F384275492%2F In keeping with its new mandate to pay closer attention to safety, the agency will be compiling a quarterly table of drugs that have been identified as having some kind of potential safety issue. The move is actually in response to a requirement in the FDA Amendments Act and the first table, to be posted on the agency web site, includes 20 different drugs identified in this year’s first quarter. The list includes Cymbalta, Tykerb, Heparin, Revlimid, Tysabri, OxyContin, Dilantin and Seroquel. Take a look for yourself. “We’ll be informing the public of certain drugs that are being evaluated for potential safety issues based on certain issues that come into the FDA reporting system,” known as AERS, or adverse events reporting system, Gerald Dal Pan, director of the Off... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1770728 Fri, 05 Sep 2008 15:37:31 +0100 1770728 http://www.medworm.com/index.php?rid=1729290&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1827 There is an excellent paper at the Archives of Internal Medicine describing a seeding trial. The authors of the paper helpfully provide a useful and concise description of a such a trial: Seeding trials are clinical trials designed by pharmaceutical companies to promote the use of pharmacotherapies that were recently approved or are under review by [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1729290 Sat, 23 Aug 2008 21:53:10 +0100 1729290 http://www.medworm.com/index.php?rid=1729291&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1826 Apologies for the lack of posting here in August. I’ve been traveling for reasons of both business and pleasure. Here are a couple of recent non-blog related items I have written. Cox AR, Wood KMG, Marriott JF, Ferner RE. Causality and definitions: How general practitioners decide what to report to spontaneous reporting schemes. Pharmacoepidemiology and [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1729291 Sat, 23 Aug 2008 20:39:09 +0100 1729291 http://www.medworm.com/index.php?rid=1692384&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F359504449%2F Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs because of flaws in the way new drugs are tested and marketed, according to research presented earlier this week at the annual meeting of the American Sociological Association. “Drug disasters are literally built into the current system of drug testing and approvals in the United States,” says Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, who gave the talk. “Recent changes in the system have only increased the proportion of new drugs with serious risks.” Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects se... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1692384 Fri, 08 Aug 2008 15:19:48 +0100 1692384 http://www.medworm.com/index.php?rid=1683440&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F356571056%2F Seems simple, yes? And so a group of Duke University researchers developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided once a drug is widely available. The upshot: “Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in post-approval populations,” they write in Health Affairs. As you may recall, most industry-sponsored clinical trials of new drugs are designed to determine efficacy in order to gain regulatory approval. But the researchers note that detecting adverse drug events is “rarely considered when sample-size calculations are undertaken for clinical trials.” Thus, the statistical power to find side effects is “inherently a by-product” of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1683440 Tue, 05 Aug 2008 17:39:31 +0100 1683440 http://www.medworm.com/index.php?rid=1645733&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1821 Adverse drug reactions (ADRs) are a massive burden on the NHS, and a significant cause of morbidity and mortality. When I worked on a cardiology ward, one of the more serious ADRs that occurred was severe haemorrhage associated with streptokinase. Rather than dying of a heart attack, the drug we gave to patients to improve [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1645733 Wed, 23 Jul 2008 06:39:41 +0100 1645733 http://www.medworm.com/index.php?rid=1508375&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F06%2Fconsumers-jazzed-by-adverse-events.html As reported by FDA News and Pharmalot, consumers are outpacing physicians in the number of drug adverse events reported to the FDA.According to the FDA's numbers (here), in 2007, consumers contributed about 174,000 AERs (adverse event reports) to the FDA, whereas physicians submitted exactly 121,000. Consumers have been outpacing physicians in reports submitted since 2004-2005 when the Vioxx withdrawal was big news.But healthcare providers -- which include pharmacists and "other" healthcare professionals -- continue to submit many more reports than do consumers as the FDA chart below shows:It's interesting to note that the RATE OF INCREASE in the number of reports submitted by consumers in the years 2004 through 2007 is much higher than that for physicians and other healthcare providers, w... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1508375 Wed, 11 Jun 2008 13:09:00 +0100 1508375 http://www.medworm.com/index.php?rid=1509073&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F309593783%2F Consumers became the major source of adverse event reports to the FDA in 2006, replacing physicians, FDA News reports. In 1998, consumers reported 23,691 adverse events, compared with 48,314 physician reports. By 2006, a tipping point occurred - there were 127,475 consumer reports versus 113,444 physician reports, according to FDA data. And last year, the gulf grew wider - consumers reported 174,216 adverse events in 2007, which was 53,216 more than reported by docs, according to the data. Why the shift? FDA News speculates that consumers may have greater awareness of safety issues. That seems to be a reasonable assumption, given the headlines over antidepressants and Vioxx in 2004, a trend that continued last year with Avandia and Chantix. However, we would point out that safety issues ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1509073 Wed, 11 Jun 2008 12:32:24 +0100 1509073 http://www.medworm.com/index.php?rid=1497458&cid=t_108521_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F06%2Fchantix-roundtable-apparently-not-round.html Discussion":"Based on the poem that you posted last week [here], we know that you were anxious to attend our media roundtable today. We’re sorry that you couldn't make it. Would be happy to set up some time with you to speak with some of our medical and safety folks to address your questions."Thanks, Ray. I'm sorry I couldn't make it also, but not so sorry if you really had a roundtable discussion (did I mention that I expected a roundtable?). [I was completely wiped out after my Wednesday night Networking Dinner Meeting in Princeton, NJ. Which was a great success by the way!]But let's put the roundness of the table aside. The important point is to have a "discussion" and your comment is a start. And I WOULD like to speak with some of your medical and safety folks. Here are the points I ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1497458 Fri, 06 Jun 2008 11:08:00 +0100 1497458 http://www.medworm.com/index.php?rid=1464200&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296527436%2F The effort, called Sentinel Initiative, will be the first time the FDA will have an opportunity to monitor almost immediately how drugs are affecting the public. To do so, the agency will mine databases of more than 20 million patients who receive their drugs through Medicare. The idea, of course, is to catch side effects that might otherwise go undetected for months or years. “This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Mike Leavitt, the HHS Secretary, says in a statement. “We are moving from reactive dependence on voluntary reporting of safety concerns - to proactive surveillance of medical products on the market.” Last month, by the way, the FDA and Wellpoint announced plans to do the same thing. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464200 Fri, 23 May 2008 12:25:51 +0100 1464200 http://www.medworm.com/index.php?rid=1437096&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288653659%2F The idea is to distinguish between adverse events and unanticipated problems in clinical trials, and to clarify when problems must be reported to institutional review boards, FDAnews reports. And after releasing the final guidance, the agency will “probably institute regulatory changes to make it clearer,” Jean Toth-Allen, a biophysicist with the FDA’s Good Clinical Practices Program, told the annual conference of the Association of Clinical Research Professionals, according to FDAnews. (Here is the draft guidance from last year). As you may know, a sponsor must report serious and unexpected adverse events to the FDA. While clinical investigators aren’t required to report adverse events that don’t fall into this category to the IRB, they must record all adverse events on ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437096 Mon, 12 May 2008 12:29:10 +0100 1437096 http://www.medworm.com/index.php?rid=1436718&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2F%2Fwordpress%2Fwp-content%2Famericancliche.mp3 Just testing Podpress. Risk-benefit discussion from American Cliche. (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1436718 Mon, 12 May 2008 09:43:21 +0100 1436718 http://www.medworm.com/index.php?rid=1426773&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F285334471%2F Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports. The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012), according to FDA News. In a draft Drug Safety Five-Year Plan that the agency updates annually and issued for comment last Friday, the FDA signals its intention to use the fees t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426773 Wed, 07 May 2008 11:56:21 +0100 1426773 http://www.medworm.com/index.php?rid=1420494&cid=t_108521_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F05%2Fin-defense-of-insulin-pumps.html I never thought I would write something with a headline like this -- as a former insulin pump wearer myself, I usually argue that the benefits of insulin pumps are too often vastly overstated and that I've attained comparable glycemic control without the expensive device. That's not to say that some people don't benefit from them, particularly people whose basal rates vary considerably throughout the day, or those whose sensitivity to insulin is such that they require dosage precision smaller than 1/2 units, but I still believe that pump evangelists suggest that the answer to everyone's diabetes management can be answered with a pump.Regardless, at the beginning of every month, when the new editions of various scientific and medical journals are released, my RSS reader is bombarded with ne... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1420494 Mon, 05 May 2008 14:25:00 +0100 1420494 http://www.medworm.com/index.php?rid=1388837&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1773 Because all medicines have the potential to cause adverse effects, the safety of prescribed medicines is a central concern for health professionals. The initial decision to resort to pharmacological treatment, the choice of drug, and the management and monitoring of the patient require knowledge of drug-induced disease. Additionally, a wider public health duty exists for [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1388837 Mon, 21 Apr 2008 08:53:48 +0100 1388837 http://www.medworm.com/index.php?rid=1369635&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1762 Y Lliwedd, taken on the way down as the clouds lifted. On Friday I made a quick ascent of Snowdon from Pen-y-Pass using the easy Miners track, before a conference at Bangor University. I had the choice of mountain biking in the rain, or walking in snow about 550m. The second seemed the drier option, so [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1369635 Sun, 13 Apr 2008 22:07:07 +0100 1369635 http://www.medworm.com/index.php?rid=1362344&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1759 The past few weeks have had a few interesting papers published on the subject of medicines and children. Children are often ill-served by medication, partly due to the difficulties associated with medication use in children and running clinical trials, and partly because of pharmaceutical companies lack of interest in obtaining paediatric licences for a small [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1362344 Wed, 09 Apr 2008 23:30:07 +0100 1362344 http://www.medworm.com/index.php?rid=1347613&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263479204%2F Actually, we just returned from the bank and the post office, but could use a good cup of coffee. So while our water is boiling (we fancy that metaphor), we thought this would be a good time to catch up with some of the stray items that were rattling around our computer while we were out. And of course, thanks for your patience. Hope your day is going well…. The UK’s National Health Service is spending nearly $4 billion annually to treat patients who had adverse reactions to drugs, according to new figures from the Compass think tank. The amount of money spent on hospital care for those given the wrong med or who suffered a side effect could pay for 10,000 new midwives or easily cover the estimated cost of combating MRSA infections, The Guardian writes. Pfizer plans to launch a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347613 Thu, 03 Apr 2008 18:08:29 +0100 1347613 http://www.medworm.com/index.php?rid=1344607&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262723865%2F A new poll finds that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doctor or hospital, but only 35 percent were aware that they can report these side effects to the FDA and only 7 percent indicated they would inform the agency. Instead, 79 percent reported they would tell their doctor, although conventional widsom says not all docs send all those side effect reports to the FDA MedWatch system. In 2004, about 423,000 adverse events were collected by the FDA, even though drug reactions account for nearly 700,000 emergency room visits each year, according to Consumers Union, which notes that drugmakers are required to report adverse events to the FDA, yet docs and patients do so voluntarily. An Institute of Medicine re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344607 Wed, 02 Apr 2008 15:18:26 +0100 1344607 http://www.medworm.com/index.php?rid=1327411&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1747 So what happens when you report a suspected adverse drug reaction to a scheme like the UK’s Yellow Card scheme or the US Medwatch scheme? Although individual reports are examined, large amounts of data can be used to look for drug safety signals. Such signals are a sign that an adverse effect may be associated [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1327411 Wed, 26 Mar 2008 00:48:33 +0100 1327411 http://www.medworm.com/index.php?rid=1311465&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F253758249%2F More than 3 percent of all deaths seem to be caused by adverse reactions to medical drugs, according to new research, according to a report in Nature. If substantiated by further work, this would make fatal adverse drug reactions the 7th most common cause of death in Sweden, where the research was done. James Ritter, the editor-in-chief of the British Journal of Clinical Pharmacology, which published the research, calls the finding “striking.” “It is a surprisingly high figure,” Donald Singer, a pharmacology expert at the University of Warwick, tells Nature, while wondering if the results can easily be generalized to other areas. Adverse drug reactions are known to be responsible for between 3 percent and 12 percent of hospital admissions, and fatal drug reactions account f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1311465 Tue, 18 Mar 2008 17:26:32 +0100 1311465 http://www.medworm.com/index.php?rid=1268594&cid=t_108521_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F243439776%2F Last September, Congress approved a major drug safety bill requiring that all drug print ads include adverse event reporting info, such as a toll-free telephone number and an easy-to-use web site. But as Consumers Union notes, the FDA must conduct a study to be completed in March to determine whether the same info should also be included in TV ads. And so the consumer-advocacy group is circulating a petition that it hopes will attract at least 50,000 signatures, which will then be sent to the FDA to “demand” the agency include the same adverse-event reporting info on TV ads. “If the FDA is really serious about finding out how drugs work in the millions of people who take them each day, it should make it as easy as possible for consumers to report side effects,” Kim Wi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1268594 Fri, 29 Feb 2008 17:39:31 +0100 1268594 http://www.medworm.com/index.php?rid=1241728&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1722 There are plenty of instances of similar sounding drug names causing confusion and adverse events in patients, but this is the first time I’ve seen a similar sounding pharmaceutical factory causing adverse drug reactions. The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1241728 Tue, 19 Feb 2008 16:36:01 +0100 1241728 http://www.medworm.com/index.php?rid=1223612&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1719 I’m quoted in this article at The Pharmaceutical Journal in relation to general practitioner reporting. “It is really important that we don’t lose the bedrock of GPs because they have the most intense relationships with patients,” said Anthony Cox, a pharmacovigilance pharmacist for the West Midlands Centre for Adverse Drug Reactions. “There has been a slight dip [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1223612 Mon, 11 Feb 2008 23:10:11 +0100 1223612 http://www.medworm.com/index.php?rid=1216444&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1717 I am quoted in tomorrow’s BMJ in an article entitled Most doctors still don’t report adverse reactions to drugs. My comments were made at the Medicines and Healthcare Products Regulatory Agency conference in Birmingham this Monday. Anthony Cox, a pharmacist at the West Midlands Centre for Adverse Drug Reactions, studied what motivates a GP to report [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1216444 Thu, 07 Feb 2008 23:53:49 +0100 1216444 http://www.medworm.com/index.php?rid=1211994&cid=t_108521_86_f&fid=36669&url=http%3A%2F%2Ffadelibrary.wordpress.com%2F2008%2F02%2F06%2F368%2F To use this journal you’ll need your NHS Athens password from Liverpool PCT (You can register here to get one if you work for the PCT.  If you need any training for this or any other electronic resources and you work for the PCT use the contact form at the bottom of this post to request it. Quality Lines David P Stevens Qual Saf Health Care 2008; 17: 1. [Extract] [Full text] [PDF] Handovers and Debussy D P Stevens Qual Saf Health Care 2008; 17: 2-3. doi:10.1136/qshc.2007.025916 [Extract] [Full text] [PDF] Structuring flexibility: the potential good, bad and ugly in standardisation of handovers E S Patterson Qual Saf Health Care 2008; 17: 4-5. doi:10.1136/qshc.2007.022772 [Extract] [Full text] ... Fade Library blogs http://www.medworm.com/rss/comments.php?id=1211994 Wed, 06 Feb 2008 13:49:23 +0100 1211994 http://www.medworm.com/index.php?rid=1161152&cid=t_108521_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F219027354%2F You say po-tae-to I say po-ta-to. Calcium supplements are now under fire. For years it has been thought that prescribing calcium to post menopausal women helped maintain bone health as well as possibly reducing the risk of high cholesterol. Apparently that news is ’so yesterday’. Researchers at the University of Auckland examined the effects of calcium supplementation on heart attacks stroke and sudden death. 1,471 healthy post-menopausal women aged 55 years or over took part in the study. And just what did they find? Dietary calcium intake was assessed and women were seen every six months over five years. Adverse events were recorded at each visit. Heart attacks were more commonly reported in the calcium group. The occurrence of any three vascular events (heart attack, stroke ... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=1161152 Fri, 18 Jan 2008 19:34:28 +0100 1161152 http://www.medworm.com/index.php?rid=1153926&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1699 There are still places available at the MHRA conference, Risk Management of Medicines in EU: Current Experience - Future Direction, on the 4th of February. I’ll be speaking about my qualitative research into the motivating factors which influence general practitioners’ decisions to report adverse drug reactions to the Yellow Card scheme. (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1153926 Tue, 15 Jan 2008 23:03:51 +0100 1153926 http://www.medworm.com/index.php?rid=1103376&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1691 Craig Brown writes: A reader of my parodic A-Z of Eth!cal PR column by Su Barking has kindly sent in a cutting from the magazine PR Week, dated November 9, 2007. “Clew Communications is to provide PR support for the relaunch of the controversial drug Thalidomide,” it reads. A photograph of the MD of Clew Communications, Mary Hicks, [...] (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1103376 Tue, 18 Dec 2007 14:52:55 +0100 1103376 http://www.medworm.com/index.php?rid=1093194&cid=t_108521_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2007%2F12%2Ftoxic-epidermal-necrolysis-and.html For those who don't know what TEN is. I have a picture for you. Toxic epidermal necrolysis (TEN) is a clinical syndrome characterized by severe exfoliative skin changes, erosive mucosal involvement, and potentially life-threatening multisystem involvement. Although this syndrome is considered uncommon, its true incidence may be underestimated because of a spectrum of manifestations that may lead to misdiagnosis of milder forms of the disease. TEN most commonly occurs in adults and is seen slightly more often in females. All races are affected Yesterday, the FDA issued guidance for pharmacogenomic testing of patients taking the medication carbamazepine. What is this drug? It is used in prevention of seizures treatment of mood disorders and schizophrenia. More than 100 drugs have been implic... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=1093194 Thu, 13 Dec 2007 00:02:00 +0100 1093194 http://www.medworm.com/index.php?rid=1039976&cid=t_108521_109_f&fid=34504&url=http%3A%2F%2Fwww.blacktriangle.org%2Fblog%2F%3Fp%3D1672 Lots of interesting things happening. The withdrawal of lumiracoxib is covered at adr.org.uk, as are the serious skin reactions to strontium ranelate. The NPC cover recent changes to rosiglitazone’s licence brought in by the FDA, and the psychiatric effects of rimonabant. (Source: Black Triangle) Black Triangle blogs http://www.medworm.com/rss/comments.php?id=1039976 Tue, 20 Nov 2007 23:29:18 +0100 1039976