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 events'. Sat, 03 Sep 2011 02:10:46 +0100 http://www.medworm.com/index.php?rid=5159206&cid=t_127191_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=4953360&cid=t_127191_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_127191_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_127191_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=4945189&cid=t_127191_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=4911824&cid=t_127191_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_127191_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_127191_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_127191_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_127191_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=4841989&cid=t_127191_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_127191_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=4734608&cid=t_127191_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=4636656&cid=t_127191_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_127191_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=4507579&cid=t_127191_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=4414548&cid=t_127191_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=4331234&cid=t_127191_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=4175764&cid=t_127191_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=4040789&cid=t_127191_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=4013550&cid=t_127191_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=3999292&cid=t_127191_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_127191_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=3921074&cid=t_127191_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=3862189&cid=t_127191_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=3662922&cid=t_127191_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_127191_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=3552545&cid=t_127191_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=3511774&cid=t_127191_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=3463856&cid=t_127191_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=3374373&cid=t_127191_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_127191_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_127191_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=2912531&cid=t_127191_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=2842788&cid=t_127191_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_127191_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_127191_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_127191_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_127191_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_127191_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=2626259&cid=t_127191_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=2513171&cid=t_127191_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=2382670&cid=t_127191_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=2349717&cid=t_127191_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_127191_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=2279768&cid=t_127191_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=2061181&cid=t_127191_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=1901970&cid=t_127191_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=1770728&cid=t_127191_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=1692384&cid=t_127191_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=1508375&cid=t_127191_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_127191_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_127191_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_127191_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_127191_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=1426773&cid=t_127191_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_127191_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=1347613&cid=t_127191_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_127191_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=1268594&cid=t_127191_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=1161152&cid=t_127191_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=965330&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F172487648%2F Way back in 2002, when the Best Pharmaceuticals for Children Act was enacted, Congress required the FDA to enforce a regulation that required adding a toll-free number to product labeling for the purpose of reporting adverse events. This was two years before Vioxx was withdrawn, but safety concerns had already gained traction due to a rising number of recalls. Only two years later, the FDA published proposed regulations in the Federal Register. Now, take a quick peek at your calendar. What year is it? If you answered 2007, you are correct. And guess what? Five years later, those regs were never finalized. As the FDA Law Blog notes, the agency received rather few comments on its proposed reg, but still never published final rules. According to an October 11, 2007 Federal Register notice, &#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=965330 Sat, 20 Oct 2007 12:38:20 +0100 965330 http://www.medworm.com/index.php?rid=966606&cid=t_127191_107_f&fid=36585&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FHighlightHealth%2F%7E3%2F162040249%2F This article was published on Highlight HEALTH. (Source: Highlight HEALTH) Highlight HEALTH blogs http://www.medworm.com/rss/comments.php?id=966606 Thu, 27 Sep 2007 15:47:26 +0100 966606 http://www.medworm.com/index.php?rid=907144&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161826713%2F This is an unusual grouping - seven big drugmakers and university researchers with backing from the FDA - are teaming to study the genetic links in some patients to side effects caused by medicines. The International Severe Adverse Events Consortium will use genetic data to try to design safer drugs and to identify patients at risk. “This is what personalized medicine is really about, finding out for the individual, not just the general population…what their risks are,” Janet Woodcock, FDA deputy commissioner, tells the Associated Press. “Up until now we’ve been kind of helpless” in dealing with side effects. The project, which will be officially announced this morning, would hopefully foster breakthroughs that change patient care in as little as five ye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=907144 Thu, 27 Sep 2007 12:27:06 +0100 907144 http://www.medworm.com/index.php?rid=882990&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158278365%2F The quarterly publication, which debuted this afternoon, can be found on the main page of the FDA’s web site and will be sent by e-mail for free to anyone who subscribes. (Or you can click on this). Aimed at docs, the newsletter is being made available in response to a scathing Institute of Medicine report that found the agency is “dysfunctional.” “The role of this newsletter is to keep our medical community posted–including physicians, dentists, nurses, and pharmacists–about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products,” FDA commish Andy von Eschenbach writes in the intro. The inaugural issue contains post-marketing reviews of three drugs and ‘early safety findings&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=882990 Tue, 18 Sep 2007 22:38:01 +0100 882990 http://www.medworm.com/index.php?rid=856912&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F154556724%2F Is there a doctor in the house? The FDA received 2½ times more reports of serious health problems linked to medication in 2005 than it did in 1998, according to a study in the Archives of Internal Medicine. Reports of serious problems grew four times faster than the total number of US outpatient prescriptions, and such medication-related health problems account for an estimated 3% to 6% of hospital admissions, USA Today writes. “The overall message is that the drug-safety evaluation system is not working,” co-author Curt Furberg, a medical epidemiologist at Wake Forest University in Winston-Salem, N.C., and former member of the FDA’s drug safety and risk management advisory panel, tells the paper. “Harmful drugs are getting into the marketplace.” Another pos... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=856912 Mon, 10 Sep 2007 12:01:44 +0100 856912 http://www.medworm.com/index.php?rid=2510396&cid=t_127191_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F09%2F04%2Freporting-drug-side-effects-one-click-away%2F Filed under: Type 1, Type 2, Childhood, Adult Onset, Drugs, Allie Beatty, Support, PersonalitiesA recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this? The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc. Your doctor is too bus... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=2510396 Mon, 03 Sep 2007 23:00:00 +0100 2510396 http://www.medworm.com/index.php?rid=817758&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F147340215%2F A new study of 650 patients who were prescribed a cholesterol med found that 87 percent who experienced an adverse symptom, such as memory or nerve pain, or memory loss, spoke to their doc about a possible connection. Most of the time, patients initiated discussion of a possible link between the drug and the side effects. And the docs were very likely to dismiss a connection even when literature existed to support the contention. “A number of patients stated their physician attributed their problems to age or imagination, dismissed the importance of their symptoms or stated that a connection of symptoms to statins was not possible,” wrote the researchers in the latest issue of Drug Safety. “Assuming that physicians would not likely report adverse drug reactions in these i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=817758 Thu, 23 Aug 2007 14:45:01 +0100 817758 http://www.medworm.com/index.php?rid=807037&cid=t_127191_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F145511825%2F As old age sets in, it’s not unusual for an elderly person to be prescribed a growing number of meds to treat a growing number of afflictions. But this remedy, however well-intentioned, can cause a problem of its own - a growing number of adverse events, serious ones that can even result in poisoning. A report in The Sydney Morning Herald cites the example of Don Ireland, a chipper 91-year-old (that’s him in the picture). But a few years ago, Ireland was in and out of hospitals due to falls, strokes and suspected heart attacks. He was often asleep, hard to manage when awake, and on the verge of being placed in a nursing home. Then came the diagnosis - too many meds. In fact, Ireland was on 17 drugs, and another eight, as needed. The regimen was cut to three. Now, he’s as ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=807037 Sat, 18 Aug 2007 14:32:15 +0100 807037 http://www.medworm.com/index.php?rid=693271&cid=t_127191_132_f&fid=35011&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fmndoci%2F%7E3%2F127582394%2F At the recent DIA Annual Meeting the top subject, or so it appeared, on everyone’s minds was safety. Adverse event reporting, pharmacovigilance, etc were buzzwords that one didn’t have to look far to hear. If someone asked you, as a life scientist, what the top priorities in healthcare should be, what would you say? In my opinion, we need to be thinking seriously about how we can change drug development paradigms in the context of all the information that we have to try and make sure that attrition rates are decreased dramatically. Current efforts are just extensions of what we’ve been doing for years, and they are not working. Safety would be right up there, along with trying to rebuild public trust. Technorati Tags: Healthcare, Adverse Events, DIA, Drug Development (Sou... business|bytes|genes|molecules blogs http://www.medworm.com/rss/comments.php?id=693271 Sun, 24 Jun 2007 21:11:37 +0100 693271