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 'food and drug administration'. Sat, 03 Sep 2011 02:01:38 +0100 http://www.medworm.com/index.php?rid=5130744&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-approves-ges-newest-ct-scanner%2F2011.08.15 GE Healthcare has received the FDA OK for its Optima CT660 computed tomography (CT) system. The CT660, which is already available in Europe, Latin America and Asia, distinguishes itself by its compact footprint combined with a modular design and low dose imaging. In addition, it is also one of the most energy efficient CT scanners available and has an “environmental design” that eases refurbishment and end-of-life recycling. The scanner itself is scalable from 32 to 128 slices through purchasable options and features automatic table positioning and a color 12-inch integrated gantry display monitor. (more…) *This blog post was originally published at Medgadget* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5130744 Mon, 15 Aug 2011 21:05:47 +0100 5130744 http://www.medworm.com/index.php?rid=5118762&cid=t_355796_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fstudies-point-complexity-hit-transition Like it or not, spending the public’s money on the HIT transition is a Catch-22. On the one hand, billions of dollars are being spent on a promise. On the other hand, there’s no way of knowing for sure whether the promise will come true until those billions are spent. read more (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=5118762 Wed, 10 Aug 2011 14:19:03 +0100 5118762 http://www.medworm.com/index.php?rid=5077688&cid=t_355796_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=5062246&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhow-effective-are-antidepressants%2F2011.07.24 Antidepressant drugs have been getting a bad rap in the media. I’ll just give 3 examples: On the Today show, prominent medical expert Tom Cruise told us Brooke Shields shouldn’t have taken these drugs for her postpartum depression. In Natural News, “Health Ranger” Mike Adams accused pharmaceutical companies and the FDA of covering up negative information about antidepressants, saying it would be considered criminal activity in any other industry. And an article in Newsweek said  “Studies suggest that the popular drugs are no more effective than a placebo. In fact, they may be worse.” Yet psychiatrists are convinced that antidepressants work and are still routinely prescribing them for their patients. Is it all a Big Pharma plot? Who ya gonna believe? Inquiring minds want ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5062246 Sun, 24 Jul 2011 16:00:36 +0100 5062246 http://www.medworm.com/index.php?rid=5028199&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Fwww.fastercures.org%2Fdocuments%2Ffile%2FFasterCures%2520Chronicle%2520of%2520Philanthropy%2520Articles%2520Final%281%29.pdf The following is a guest post by Margaret Anderson, executive director of FasterCures/The Center for Accelerating Medical Solutions, an “action tank” working to improve the medical research system and speed up the time it takes to get important new medicines from discovery to patients. Margaret also serves as vice president of the Alliance for a Stronger FDA, board member for the Council for American Medical Innovation and the Coalition for the Advancement of Medical Research, and member of the Prostate Cancer Foundation Government Affairs Committee and the Institute of Medicine’s Forum on Drug Discovery, Development and Translation. In 2011, the Clinical Research Forum recognized her with an award for leadership in public advocacy. By Margaret Anderson. What’s missing today in the... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=5028199 Fri, 15 Jul 2011 13:15:00 +0100 5028199 http://www.medworm.com/index.php?rid=5008184&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2F2NrKe40onN8%2F By Archelle Georgiou. The use of Avastin for breast cancer was addressed by the U.S. Food and Drug Administration this week. The outcome was devastating for Roche and an emotional one for many women who believe the FDA is subjecting them to a death sentence.  As usual, there are a variety of perspectives to take into consideration. The history: In 2008, Avastin was given preliminary approval by the FDA for the treatment of breast cancer on the condition that the company would do more studies to demonstrate its effectiveness. Many women have been successfully treated with Avastin — a billion dollar drug for Roche. But when Roche submitted the required follow-up studies in 2010, the data showed that there was no benefit from the drug for treating breast cancer.  Studies did not show ... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=5008184 Tue, 05 Jul 2011 13:00:08 +0100 5008184 http://www.medworm.com/index.php?rid=4997643&cid=t_355796_112_f&fid=34971&url=http%3A%2F%2Fblog.drmalpani.com%2F2011%2F07%2Fhow-does-your-doctor-interpret-your-hsg.html An HSG ( hysterosalpingogram, X-ray of the uterus and tubes, www.drmalpani.com/hsg.htm) is one of the commonest tests performed for infertile women , to confirm their uterine cavity is normal and their fallopian tubes are open. How does the doctor interpret your HSG films ? Sometimes, the films are of such poor quality , that we cannot make any sense of them. This maybe because the procedure was not done properly; or because the film was overexposed or under-exposed. Sometimes, the patient moves during the procedure, as a result of which the images may be blurred or out of focus. When this happens, this is a major shame, because we are then forced to repeat the study. I hate doing this, because I know the HSG can be quite painful ! This is why it’s best to do the HSG in a clinic which ha... The Patient's Doctor blogs http://www.medworm.com/rss/comments.php?id=4997643 Mon, 04 Jul 2011 03:36:00 +0100 4997643 http://www.medworm.com/index.php?rid=4952834&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2F-eAzFLBs7og%2F Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States.  These warnings mark the first change in cigarette warnings in more than 25 years and are a significant and necessary advancement in communicating the dangers of smoking. The final set of cigarette health warnings contains nine different text warnings and accompanying color graphics to: increase awareness of the specific health risks associated with smoking, such as death, addiction, lung disease, cancer, stroke and heart disease; encourage smokers to quit; and empower youth to say no to tobacco. The above is one of the new warnings; to see more of the new warnings of to learn more about them click here. Watch today’s ann... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=4952834 Tue, 21 Jun 2011 13:41:40 +0100 4952834 http://www.medworm.com/index.php?rid=4953393&cid=t_355796_160_f&fid=36189&url=http%3A%2F%2Fwww.skinmdblog.com%2F517%2Fprotect-your-skin-this-summer%2F It’s the summer and while you proceed to spend some fun in the sun with your family and friends, it’s important that you properly protect your skin from overexposure—too much sun can lead not only to painful sunburns, but skin cancer and early skin aging such as unattractive wrinkles and sun spots as well. But when it comes to selecting the best sunscreen for you and/or your family, sometimes it’s confusing. So confusing in fact, that the Food and Drug Administration has mandated new sun screen regulations so that consumers can better understand labels and get the protection they need. Under the new regulations, which will take effect next summer, sunscreens will now have to pass a “broad spectrum” test before they can be placed on the market. This test will... Skin MD blogs http://www.medworm.com/rss/comments.php?id=4953393 Mon, 20 Jun 2011 18:31:52 +0100 4953393 http://www.medworm.com/index.php?rid=4934159&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhat-to-expect-from-the-new-sunscreen-labels%2F2011.06.16 Yesterday, the U.S. Food and Drug Administration released the new rules regarding labeling of sunscreen.  The goal is to make it easier for the average person to chose a sunscreen. The new labels will not be in place until next summer, so you need to be aware. When the new labels are in place, NO sunscreen will be allowed to be labeled as a SUNBLOCK or as WATERPROOF. Under the new labeling rules Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test. Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. A warning statement will be required on any product that is not Broad Spectrum, or that is Broad Spect... Better Health blogs http://www.medworm.com/rss/comments.php?id=4934159 Thu, 16 Jun 2011 16:00:00 +0100 4934159 http://www.medworm.com/index.php?rid=4676779&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FQjV-tryLFQ4%2F By Glenna Crooks. Having been engaged in rare disease research and orphan drug development for many decades and as one who continues behind-the-scenes to encourage the work, events of the last few weeks about Makena’s launch sent chills through me.  The firestorm that followed created some heat but none sufficient to help relieve the shivers. Others might declare the outcome a “win” but the more I read, the worse it seems. I’m not privy to what really happened, only what the press reports. It does not look good… for virtually anyone of the players involved, especially the critics.  Those critics raised tough questions and to date only the company has faced them. It’s about time the critics themselves –and perhaps others as well – face some.    For those who’ve mi... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=4676779 Mon, 04 Apr 2011 09:31:25 +0100 4676779 http://www.medworm.com/index.php?rid=4642716&cid=t_355796_112_f&fid=34971&url=http%3A%2F%2Fblog.drmalpani.com%2F2011%2F03%2Fwhat-medicine-can-teach-economists-and.html There's a lot doctors can learn from other professionals - and there's a lot doctors can teach others as well !An interesting "recent" innovation in economics is the introduction of "controlled trials" to determine the true impact of interventions to help alleviate poverty. Common sense would suggest that giving the poor loans will them help to turn around their lives - but in reality, this is not what usually happens. The road to hell is paved with good intentions, and "aid" can often end up killing initiative ; fueling waste and corruption; and breeding dependence ! Handouts don't always work well - and it's easy to waste a lot of money very quickly ! The only way to find out what works and what does not work is to perform experiments in the field - something which doctors are very good ... The Patient's Doctor blogs http://www.medworm.com/rss/comments.php?id=4642716 Mon, 28 Mar 2011 03:38:00 +0100 4642716 http://www.medworm.com/index.php?rid=4626769&cid=t_355796_86_f&fid=38272&url=http%3A%2F%2Flaikaspoetnik.wordpress.com%2F2011%2F03%2F23%2Fkaleidoscope-3-2011-wk-12%2F It has been long since I have posted a Kaleidoscope post with a “kaleidoscope” of facts, findings, views and news gathered over the last 1-2 weeks. There have been only 2 editions: Kaleidoscope 1 (2009 wk 47) and 2 (2010 wk 31). Here is some recommended reading from the previous two weeks. Benlysta (belimumab) approved by FDA for treatment of lupus. Belimumab is [...] (Source: Laika's MedLibLog) Laika's MedLibLog blogs http://www.medworm.com/rss/comments.php?id=4626769 Wed, 23 Mar 2011 11:37:20 +0100 4626769 http://www.medworm.com/index.php?rid=4592394&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fa-new-treatment-for-lupus%2F2011.03.15 Lupus, an autoimmune disease, [recently] turned up on the front page of the Wall Street Journal (WSJ). It cropped up, also, on the first page of the New York Times business section, and elsewhere. Scientific American published a nice online review just now. The reason is that the FDA has approved a new monoclonal antibody for treatment of this condition. The drug belimumab (Benlysta), targets a molecule called BlyS (B-lymphocyte Stimulator). The newspapers uniformly emphasize that this drug marks some sort of triumph for Human Genome Sciences, a biotech company that first reported on BlyS in the journal Science way back in 1999. BlyS triggers B cells to produce antibodies that in patients with lupus tend to bind and destroy their own cells’ needed machinery, causing various joint, lung... Better Health blogs http://www.medworm.com/rss/comments.php?id=4592394 Tue, 15 Mar 2011 18:00:36 +0100 4592394 http://www.medworm.com/index.php?rid=4575058&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbad-medical-marketing-an-ad-the-fda-should-pull%2F2011.03.11 If ever a medical device company crossed a line with their marketing, this one has. Essure, which makes a sterilization device for women, is trying to scare men away from vasectomy in order to drive women to use their device. “We made men watch footage of an actual vasectomy,” says the female voiceover — and then they proceed to show men’s reactions to watching a surgical procedure, with “That’s frickin’ gross, man” being the most memorable quote. The final tagline: “You can only wait so long for him to man up.” Yeah, and to be sure he doesn’t, they’ve created this ad. The ad is slimy, harmful, obnoxious, and just plain stupid. A couple’s decision as to which sterilization procedure is best for them should be one informed by real information, not f... Better Health blogs http://www.medworm.com/rss/comments.php?id=4575058 Fri, 11 Mar 2011 16:00:26 +0100 4575058 http://www.medworm.com/index.php?rid=4565905&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Findependent-peer-reviewed-scientific-journals-just-how-independent-are-they%2F2011.03.09 On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled “Spontaneous explosion of implantable cardioverter-defibrillator” by Martin Hudec and Gabriela Kaliska. In the pdf of that case report a figure containing a color photo of the affected patient’s chest, chest X-ray, and two pictures of the extracted device (one seen here) were included. The pictures and case presentation were dramatic and the case very rare. Both were perfect reasons to report such an important case to the medical literature. And so these doctors sent the case to Europace on June 29, 2010, and the article was accepted after revision on August 16, 2010, with the article appearing online September 27, 2010. The authors must have felt v... Better Health blogs http://www.medworm.com/rss/comments.php?id=4565905 Wed, 09 Mar 2011 16:00:00 +0100 4565905 http://www.medworm.com/index.php?rid=4549736&cid=t_355796_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FAcDaptYtsMA%2F By Walter OlsonIn recent weeks the press has been reporting widespread alarms about shortages of many frequently used hospital drugs [L.A. Times/Chicago Tribune, Scranton Times-Tribune, KMGH (Colorado hospitals swapping drugs in short supply), The Columbian] The drugs running short include various antibiotics, anesthetics, chemotherapy drugs and others, including many generic compounds long since approved by the federal Food and Drug Administration (FDA). "The most troubling aspect is that it is critical drugs for which there are limited alternatives. Many are involved in cancer care and surgery," one hospital pharmacist told the Chicago Tribune's reporter. While a variety of factors have played a role in the shortages, including lawsuits and economic retrenchment by some drugmakers, there... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4549736 Fri, 04 Mar 2011 18:28:06 +0100 4549736 http://www.medworm.com/index.php?rid=4507279&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthink-zinc-for-a-cold-not-me%2F2011.02.22 Media channels are a-twitter with the news that zinc can beat the common cold. CBS News, the LA Times, the Huffington Post, and hundreds of others are treating a quiet research report as big news that will have a life-changing effect. After reading the report and doing a little digging into the dark side of zinc, I’m not rushing out to stock up on zinc lozenges or syrup. The latest hubbub about zinc was sparked by a report from the Cochrane Collaboration. This global network of scientists, patients, and others evaluates the evidence on hundreds of different treatments. In the latest review, on zinc for the common cold, researchers Meenu Singh and Rashmi R. Das pooled the results of 13 studies that tested zinc for treating colds. By their analysis, taking zinc within 24 hours of first no... Better Health blogs http://www.medworm.com/rss/comments.php?id=4507279 Tue, 22 Feb 2011 22:00:38 +0100 4507279 http://www.medworm.com/index.php?rid=4507280&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fselecting-targeted-therapies-online-the-future-of-personalized-cancer-treatment%2F2011.02.22 The word cancer comes from the greek word for crab “karkinos,” so named by Hippocrates who visualized the tumor and its surrounding vessels looking like a crab, dug stubbornly into the sand with its legs. We know far more about cancer today than the ancient Greeks, but the vision of an entrenched opponent, almost impossible to extract whole, appears to be vividly prescient. What we have realized over the last half century is that removal of the visible tumor is not enough. Even as we learned how to do bigger and more destructive surgeries, the cancer still managed to sneak back in, growing later at different locations. The crab’s legs are still embedded in the patient. Thus the discovery that certain chemicals could extinguish these rogue cells opened the modern era of cancer therapy... Better Health blogs http://www.medworm.com/rss/comments.php?id=4507280 Tue, 22 Feb 2011 20:00:25 +0100 4507280 http://www.medworm.com/index.php?rid=4498274&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdeep-brain-stimulation-experts-raise-alarms-about-aggressive-marketing%2F2011.02.19 A paper published in the February issue of Health Affairs – discussed at length in an article in the New York Times – contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD). In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep b... Better Health blogs http://www.medworm.com/rss/comments.php?id=4498274 Sat, 19 Feb 2011 20:00:39 +0100 4498274 http://www.medworm.com/index.php?rid=4495203&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fmri-safe-pacemakers-available-in-u-s-hospitals-soon-what-it-means-for-heart-patients%2F2011.02.18 This was the Guest Blog at Scientific American on February 16th, 2011. New wave of MRI-safe pacemakers set to ship to hospitals This week Medtronic will begin shipping to hospitals in the United States the first pacemaker approved by the FDA as safe for most MRI scans. For consumers, it is a significant step in what is expected to be a wave of new MRI-compatible implanted cardiac devices. But this is an example of one technology chasing another and the one being chased, the MRI scanner, is changing and is a step ahead of the new line of pacemakers. The pacemaker approved for U.S. distribution is Medtronic’s first-generation pacemaker with certain limitations, while its second-generation MRI-compatible pacemaker is already in use in Europe where approval for medical devices is not as dem... Better Health blogs http://www.medworm.com/rss/comments.php?id=4495203 Fri, 18 Feb 2011 21:00:00 +0100 4495203 http://www.medworm.com/index.php?rid=4489676&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ftreating-depression-the-shock-value-of-electroconvulsive-therapy%2F2011.02.16 Electroconvulsive therapy (ECT) is considered to be a highly effective treatment for depression. The story goes that roughly 90 percent of patients respond. The downside is that it requires general anesthesia with all its attendant risks, and patients may suffer from headaches and memory loss. The memory loss is often mild, but there are cases where it is profound and very troubling. As with any psychiatric treatment — or so it seems — there are those who say it saved them and those who say it destroyed them. Because the risks aren’t minor, the procedure is expensive and often done on an inpatient unit, and people generally don’t like the idea of having an IV line placed, being put under, then shocked through their brain until they seize, only to wake up groggy and... Better Health blogs http://www.medworm.com/rss/comments.php?id=4489676 Wed, 16 Feb 2011 21:00:00 +0100 4489676 http://www.medworm.com/index.php?rid=4445778&cid=t_355796_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FFRjDzJyzXlE%2F By Walter OlsonThis weekend the Washington Post and New York Times took a closer look at a development mentioned in this space a while back and in a related Cato audio, namely growing federal pressure on small producers of artisan and farmstead cheeses. Here's the Post: ....artisanal cheesemakers, and their boosters in the local-food movement, say they are being unfairly targeted. They say the FDA does not understand their craft and is trying to impose standards better suited for industrial food companies. ... Listeria is ubiquitous in the environment, but the FDA has a zero-tolerance rule for it in ready-to-eat food such as cheese. If the bacteria are present, the food is considered adulterated and cannot be sold. Some countries, including cheese-loving France, tolerate minute amounts of ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4445778 Mon, 07 Feb 2011 20:36:36 +0100 4445778 http://www.medworm.com/index.php?rid=4433289&cid=t_355796_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F02%2F03%2Ffda-awards-1-6m-orphan-drug-grant-for-clinical-phase-ii-development-of-egen-001-for-treatment-of-ovarian-cancer%2F EGEN, Inc. announced that the Food and Drug Administration (FDA) awarded the company a four-year grant of $1.6 million to assist in the phase II clinical development of EGEN-001, the company’s lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer. EGEN, Inc. announced that the Food and Drug Administration (FDA) [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4433289 Thu, 03 Feb 2011 21:52:52 +0100 4433289 http://www.medworm.com/index.php?rid=4429017&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwere-overdosing-on-sodium-whose-responsibility-is-it%2F2011.02.02 I confess to loving Campbell’s tomato bisque soup. I mix it with 1 percent-fat milk and it’s hot and delicious and comforting, but one of the worst food choices I could make because one cup contains more sodium than I should have in a day. Knowing this, I have already relegated it to an occasional treat. But by the end of this blog post I will do more. We are overdosing on sodium and it is killing us. We need to cut the sodium we eat daily by more than half. The guidelines keep coming. The U.S. government has handed out dietary guidelines telling Americans who are over 50, all African Americans, people with high blood pressure, diabetes, or chronic kidney disease to have no more than 1,500 milligrams (mg) — or two thirds of a teaspoon — of sodium daily. That’s the majorit... Better Health blogs http://www.medworm.com/rss/comments.php?id=4429017 Wed, 02 Feb 2011 23:00:00 +0100 4429017 http://www.medworm.com/index.php?rid=4424395&cid=t_355796_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F02%2F01%2Fnovel-cancer-targeting-cornell-dot-nanoparticle-approved-for-first-in-human-clinical-trial%2F “Cornell Dots” — brightly glowing nanoparticles — may soon be used to light up cancer cells to aid in diagnosing and treating cancer. The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of the new technology. It is the first time the FDA has approved using an inorganic material [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4424395 Tue, 01 Feb 2011 23:26:35 +0100 4424395 http://www.medworm.com/index.php?rid=4411528&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-reports-on-association-of-breast-implants-and-a%25c2%25a0rare-form-of-cancer%2F2011.01.28 The FDA [has] issued an alert about a pos­sible link between breast implants — saline or sil­icone — and a rare form of lym­phoma called anaplastic large cell lym­phoma (ALCL). These lym­phoma cases are exceed­ingly rare, but the asso­ci­ation appears to be significant. The FDA iden­tified a total of approx­i­mately 60 ALCL cases in asso­ci­ation with implants, worldwide. Of these, 34 were iden­tified by review of pub­lished medical lit­er­ature from 1997 to May, 2010; the others were reported by implant man­u­fac­turers and other sources. The agency esti­mates the number of women worldwide with breast implants is between five and 10 million. These numbers translate to between six and 12 ALCL cases in the breast, per million women with breast implan... Better Health blogs http://www.medworm.com/rss/comments.php?id=4411528 Fri, 28 Jan 2011 14:00:26 +0100 4411528 http://www.medworm.com/index.php?rid=4405775&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhat-everyone-should-know-about-plastics%2F2011.01.27 Information circulating about the dangers of plastic containers has created fear and confusion. Are plastic containers toxic? Do harmful chemicals leach out into its contents? Do we need to discard all plastic containers? Recently, I interacted in a live health chat on MedHelp about the safety of plastics. Scientist, Joe Schwarcz, Ph.D., Director of McGill University’s Office for Science and Society, talked about “The Real Truth About Plastics: What You Should And Shouldn’t Worry About.” While Dr. Schwarcz states that some plastics like those made by Tupperware and Rubbermaid are safe to use, there are other plastics made of Bisphenol A (BPA) that may cause some concern, however he did not become alarmed. There is extensive information on the safety of plastics, and reading some of... Better Health blogs http://www.medworm.com/rss/comments.php?id=4405775 Thu, 27 Jan 2011 18:00:39 +0100 4405775 http://www.medworm.com/index.php?rid=4405777&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbreast-implants-and-lymphoma-new-safety-alert-from-the-fda%2F2011.01.27 From the Food and Drug Administration (FDA) safety alert yesterday: ISSUE: The FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. BACKGROUND: In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants. According to the National Cancer Institute, ALCL appears in different pa... Better Health blogs http://www.medworm.com/rss/comments.php?id=4405777 Thu, 27 Jan 2011 14:00:36 +0100 4405777 http://www.medworm.com/index.php?rid=4377568&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhead-lice-fda-approves-new-treatment%2F2011.01.20 Good news for parents, teachers, pediatricians, and others engaged in the ongoing battle against lice: The Food and Drug Administration (FDA) just approved a new treatment for head lice in children age four and older. Called Natroba, it’s a liquid that is rubbed into the hair and allowed to sit for 10 minutes before being rinsed off. Natroba is a useful addition to the anti-lice arsenal, since some head lice have become resistant to permethrin and pyrethrins, the active ingredients in over-the-counter anti-lice products such as Nix and Rid. Head lice are tiny insects that go by the big name Pediculus humanus capitis. They thrive in the warm tangle of human hair, feeding off blood in the scalp and breeding with abandon. A female lays eggs called nits that she attaches to strands of hair.... Better Health blogs http://www.medworm.com/rss/comments.php?id=4377568 Thu, 20 Jan 2011 21:30:14 +0100 4377568 http://www.medworm.com/index.php?rid=4360983&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fchewable-birth-control%2F2011.01.17 Just in time for the new year, the FDA has approved the first low-dose chewable birth control contraceptive.  The daily chew will be marketed by Watson Pharmaceuticals, Inc. Fred Wilkinson, executive vice president of Global Brands said: “We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women.” I have to ask myself: “Why?” Most birth control failures occur because the woman forgets to take the pill. Will a chewable be more reliant? Is it aimed at gals who just love chewing gum? I don’t get the concept. Marketing for this breakthrough will begin the in the second quarter of 2011. *This blog post was originally published at EverythingHealth* (Source: ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4360983 Mon, 17 Jan 2011 22:00:00 +0100 4360983 http://www.medworm.com/index.php?rid=4349516&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-restricts-acetaminophen-in-popular-pain-medications%2F2011.01.14 This is a guest post from Dr. Mary Lynn McPherson. ********** FDA Restricts Acetaminophen In Popular Pain Medications The Food and Drug Administration (FDA) made an announcement yesterday that affects one of the most common pain medications on the market, and as a consequence may affect countless numbers of the 75 million Americans who experience chronic pain (for perspective, that’s more than the number of people suffering from cancer, heart disease and diabetes combined.) The FDA has asked manufacturers of popular prescription pain medications like Vicodin or Percocet to limit the amount of acetaminophen (also known as Tylenol, or APAP) used in these drugs to no more than 325 milligrams per tablet — the equivalent of one regular-strength Tylenol tablet. The move came because rese... Better Health blogs http://www.medworm.com/rss/comments.php?id=4349516 Fri, 14 Jan 2011 13:00:05 +0100 4349516 http://www.medworm.com/index.php?rid=4304879&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-set-to-approve-new-anti-obesity-drug%2F2011.01.02 The FDA has been tough on diet drugs of late. Three years ago it scuttled an attempt to get the European diet drug rimonabant approved for use in the U.S. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin. But that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure. The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the three diet drugs mentioned above,  it usually does. (more…... Better Health blogs http://www.medworm.com/rss/comments.php?id=4304879 Sun, 02 Jan 2011 19:00:19 +0100 4304879 http://www.medworm.com/index.php?rid=4287415&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fpainkiller-safety%2F2010.12.24 Perhaps as many as one in every five American adults will get a prescription for a painkiller this year, and many more will buy over-the-counter medicines without a prescription. These drugs can do wonders — getting rid of pain can seem like a miracle — but sometimes there’s a high price to be paid. Remember the heavily marketed COX-2 inhibitors? Rofecoxib, sold as Vioxx, and valdecoxib, sold as Bextra, were taken off the market in 2004 and 2005, respectively, after studies linked them to an increased risk of heart attack and stroke. The nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin, ibuprofen (sold as Advil and Motrin), and naproxen (sold as Aleve) seem like safe bets. But taken over long periods, they have potentially dangerous gastrointestinal side effect... Better Health blogs http://www.medworm.com/rss/comments.php?id=4287415 Fri, 24 Dec 2010 16:00:34 +0100 4287415 http://www.medworm.com/index.php?rid=4233167&cid=t_355796_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FjT_21hU9b7o%2F By Walter OlsonLast Tuesday, despite warnings of regulatory overreach, the Senate voted 73-25 in favor of S. 510, the Food Safety Modernization Act, which would greatly expand the powers of the federal Food and Drug Administration and impose extensive new testing and paperwork requirements on farmers and food producers. Almost at once, however, the bill was derailed — whether temporarily or otherwise remains to be seen — by what the New York Times called an “arcane parliamentary mistake” and the L.A. Times considered a purely “technical flaw“. Roll Call put it more bluntly: “[Senate] Democrats violated a constitutional provision requiring that tax provisions originate in the House.” While the New York Times weirdly cast Senate Republicans as ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4233167 Mon, 06 Dec 2010 15:33:26 +0100 4233167 http://www.medworm.com/index.php?rid=4207281&cid=t_355796_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fx-O6LxE-TaI%2F By Walter OlsonLast week the New York Times reported on the story of Estrella Family Creamery, an award-winning, very-small-scale producer of raw milk farmstead cheeses in Montesano, Wash. The family faces a Food and Drug Administration ban on its products because the food pathogen listeria has been found in its facilities; when it expressed defiance, the FDA proceeded to stage a raid to seize its entire cheese stock. It’s not easy to sort out how large a health risk may be involved (listeria, a widely disseminated form of bacteria, poses a real danger of food poisoning, but no actual illness has been traced to Estrella cheese). I was struck, in any event, by these paragraphs from the Times account: “If the F.D.A. wanted to shut down the U.S. artisan cheese industry, all they’d ... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4207281 Sun, 28 Nov 2010 23:29:39 +0100 4207281 http://www.medworm.com/index.php?rid=4164521&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnew-cigarette-labels-from-the-fda%2F2010.11.14 The FDA will soon require new cigarette package labeling to deter smoking. So in politically-correct governmental fashion, they are asking which labels you’d like to see. (You can pick your favorites here.) My personal favorite (so far) is the one shown to the left, but its impact factor pales in comparison to this example found in England. (That, my friends, is cancer!) Ironically, it appears the FDA isn’t too sure how forceful it should be in these warnings about the dangers of smoking. They offer a cornucopia of milquetoast labeling options, many of which contain cartoons. Might such unrealistic portrayals defy they hard-hitting message they want to project? Worse, at least one cartoon (seen here) even seems to promote cigarettes AND drug use together! In an even more astoni... Better Health blogs http://www.medworm.com/rss/comments.php?id=4164521 Sun, 14 Nov 2010 22:00:00 +0100 4164521 http://www.medworm.com/index.php?rid=4118936&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-impact-of-drug-marketing-on-medical-care%2F2010.10.28 In my group practice, the Yale Medical Group, drug company-sponsored lunches and similar events have been banned. This is part of a trend, at least within academic medicine, to create some distance between physicians and pharmaceutical companies, or at least their marketing divisions. The justifications for this are several, and are all reasonable. One reason is the appearance of being too cozy, which compromises the role of academic physicians as independent experts. But the primary reason is the belief that “detailing” by pharmaceutical sales representatives has a negative effect on the prescribing habits of physicians. There is reason to believe this may be the case because of cases of bad behavior on the part of pharmaceutical marketing divisions — ghost writing white papers,... Better Health blogs http://www.medworm.com/rss/comments.php?id=4118936 Thu, 28 Oct 2010 12:00:50 +0100 4118936 http://www.medworm.com/index.php?rid=4040561&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ftop-gripes-about-drugs-and-what-they-cost%2F2010.10.07 I used to defend pharmaceutical companies. ”What companies out there have contributed more good? Should care manufacturers make more when all they do is make transportation that breaks after a few years?” It made sense to me that you should put a pot of gold at the end of the rainbow so that companies are motivated to invent more drugs and innovate. We throw a lot of money to athletes and movie stars who simply entertain us, shouldn’t we do better to those who heal us? I used to say that. I don’t anymore. No, I don’t think the drug companies are “evil.” People who say that are thinking way to simplistic. These companies are doing exactly what their shareholders want them to do: make as much money as possible for as long as possible. That’s what all companies do, right? They... Better Health blogs http://www.medworm.com/rss/comments.php?id=4040561 Thu, 07 Oct 2010 22:00:07 +0100 4040561 http://www.medworm.com/index.php?rid=4003254&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Freal-time-drug-safety-reports%2F2010.09.27 Researchers at Children’s Hospital in Boston and the University of North Carolina at Chapel Hill have developed an iPhone application that keeps you up-to-date with drug safety reports and allows you to submit any side effects directly to the FDA. The app, called MedWatcher can keep a list of medications for which you receive both official FDA alerts and news from other channels. Users can report side effects straight from the app and view other submitted reports. The researchers hope to lower the barrier to reporting side effects, increasing the participation in safety surveillance. Reports of serious adverse events are reviewed by members of the Children’s Computational Epidemiology Group and then submitted to the FDA. The app was developed using technology from the Outbreaks... Better Health blogs http://www.medworm.com/rss/comments.php?id=4003254 Mon, 27 Sep 2010 22:00:14 +0100 4003254 http://www.medworm.com/index.php?rid=3929234&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-actively-monitoring-medical-and-healthcare-apps%2F2010.09.02 Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction. James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following: The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval. By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBe... Better Health blogs http://www.medworm.com/rss/comments.php?id=3929234 Thu, 02 Sep 2010 12:00:10 +0100 3929234 http://www.medworm.com/index.php?rid=3862009&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-warning-industrial-bleach-as-a-cure-for-cancer-and-hiv%2F2010.08.12 On the heels of Scott Gavura’s superb post on dietary supplement regulation in the U.S. and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you – this is just too unbelievable not to share with science-based medicine readers. (more…) *This blog post was originally published at Science-Based Medicine* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3862009 Thu, 12 Aug 2010 22:00:48 +0100 3862009 http://www.medworm.com/index.php?rid=3827068&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdrug-to-treat-spider-veins-asclera-now-fda-approved%2F2010.08.05 The FDA recently (March 2010) approved Asclera (poliocanol) injection for the treatment of small spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter). Asclera is a detergent sclerosant and produces endothelial damage through interference with the cell’s surface lipids.and acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue. (more…) *This blog post was originally published at Suture for a Living* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3827068 Thu, 05 Aug 2010 14:00:00 +0100 3827068 http://www.medworm.com/index.php?rid=3807396&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffood-and-pesticides-the-dirty-dozen%2F2010.07.31 The Environmental Working Group (EWG) is a non-profit focused on public health. We know that the long-term consequences of eating chemicals from pesticides used on our foods is damaging to our health. The EWG analyzed data from the FDA and found that people who eat five fruits and vegetables a day from the “Dirty Dozen” are eating 10 pesticides a day. We want people to eat more fruits and vegetables, but NOT to ingest more chemicals. Rinsing reduces but does not eliminate pesticides. So what’s the answer? Rinse completely and buy the “Dirty Dozen” foods organic whenever possible. (more…) *This blog post was originally published at EverythingHealth* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3807396 Sat, 31 Jul 2010 12:00:00 +0100 3807396 http://www.medworm.com/index.php?rid=3794773&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fmedical-devices-injure-70000-kids-each-year%2F2010.07.27 FDA researchers have published a study in Pediatrics that analyzed patient records from child and teen ER visits in 2004 and 2005. The investigators are reporting that 70,000 kids each year go to the ER because of issues caused by medical devices. About a quarter of the injuries were from contact lenses, while the other major contributors were needles, wheelchairs, braces, and obstetric exam tools. The study also looked at the devices most likely to cause hospitalization, and they were found to be mostly invasive devices like ostomy appliances and implanted defibrillators. (more…) *This blog post was originally published at Medgadget* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3794773 Tue, 27 Jul 2010 17:00:25 +0100 3794773 http://www.medworm.com/index.php?rid=3767074&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fgovernment-decisions-about-avandia-and-preventive-services%2F2010.07.19 An FDA advisory panel has voted that the diabetes drug Avandia (rosiglitazone) can remain on the market, but recommended further warnings associated with its use. The panel was divided, the New York Times reported, with 12 of 33 members saying the drug should be removed from the market, 10 voting to restrict sales and strengthen the warning label, 7 recommending only strengthening the warning label, and 3 voting for no change. One panel member abstained. (New York Times) The White House yesterday announced which preventive services would be available at no charge to patients under the new healthcare legislation. Adult patients who choose a health plan after September 23 will receive mammograms, diabetes screening, and tobacco cessation counseling, among other services, at no increased cos... Better Health blogs http://www.medworm.com/rss/comments.php?id=3767074 Mon, 19 Jul 2010 23:45:57 +0100 3767074 http://www.medworm.com/index.php?rid=3746740&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2F7-under-the-radar-healthcare-changes%2F2010.07.12 Kaiser Health News proves its value once again with an under-the-radar story covering some items you won’t see in many other news sources. An excerpt: “…several lesser-known provisions also take effect in coming months that could have a lasting impact on the nation’s health care system. These provisions include eliminating patients’ co-payments for certain preventive services such as mammograms, giving the government more power to review health insurers’ premium increases and allowing states to expand Medicaid coverage to low-income adults without children. While these changes might not have gotten at lot of attention, they could help build support for the law in the run-up to the contentious mid-term elections.” Their list: • Prevention For Less... Better Health blogs http://www.medworm.com/rss/comments.php?id=3746740 Mon, 12 Jul 2010 15:00:29 +0100 3746740 http://www.medworm.com/index.php?rid=3729869&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2Fxb8dZCXYPVw%2F By Glenna Crooks. Rittenhouse Square in Philly, a holiday weekend and great weather made for the perfect place for light reading this weekend. I got magazines with the intention of doing just that – and did. It was great to be outside on warm, breezy days. However, my mood soured about half way into Spirituality&Health, reading an article about a possible new cancer therapy. It describes the observations of Mamdooh Ghoneum, PhD: cancer cells are attracted to, ‘eat’ heat-killed baker’s yeast and then die. That’s good news. It happens in labs and in mice, who apparently suffer no side effects. That’s good news, too. Approval for testing in other animals is pending. I hope he gets it. We need progress in the healing of people with cancer. Why the sour mood? Dr. Ghoneum is hero... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3729869 Mon, 05 Jul 2010 12:39:29 +0100 3729869 http://www.medworm.com/index.php?rid=3726594&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2Fxb8dZCXYPVw%2F Rittenhouse Square in Philly, a holiday weekend and great weather made for the perfect place for light reading this weekend. I got magazines with the intention of doing just that – and did. It was great to be outside on warm, breezy days.  However, my mood soured about half way into Spirituality&Health, reading an article about a possible new cancer therapy. It describes the observations of Mamdooh Ghoneum, PhD: cancer cells are attracted to, ‘eat’ heat-killed baker’s yeast and then die. That’s good news. It happens in labs and in mice, who apparently suffer no side effects. That’s good news, too. Approval for testing in other animals is pending. I hope he gets it. We need progress in the healing of people with cancer. Why the sour mood? Dr. Ghoneum is hero enough for maki... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3726594 Mon, 05 Jul 2010 12:39:29 +0100 3726594 http://www.medworm.com/index.php?rid=3718696&cid=t_355796_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoOozbSbd4XU%2F The FDA is always under the gun, and both critics and supporters often point to a lack of funding. So how much money might be headed its way in fiscal 2011? Yesterday, the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee did a mark up and suggested $2.57 billion in funding – $55 million above the budget request. This is discretionary spending. Overall, the agency would have $3.8 billion for oversight - roughly $214 million above last year’s bill - when including $1.2 billion in user fees, notes Rosa DeLauro, the Connecticut Democrat who chairs the subcommittee, who has been harping on drug safety lately. [EDITORS' NOTE: Yes, there was a math problem earlier and we have clarified the numbers]. So the proposal include... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718696 Thu, 01 Jul 2010 13:49:21 +0100 3718696 http://www.medworm.com/index.php?rid=3690834&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FROzoJirhUZw%2F Ever since Viagra hit the stores (and bedrooms) drug companies have been searching for a comparable little pink pill. Viagra didn’t seem to do much for girls (we tried it once, we felt nothing). Now there’s a new pink pill that came really close to getting FDA approval, but failed. Note: There is a poll embedded within this post, please visit the site to participate in this post's poll. Related posts:Poll: The Next President’s Top Priority Poll: Female Attitudes About Appearance Improving Medication Adherence with a Cell Phone (Source: Disruptive Women in Health Care) Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3690834 Wed, 23 Jun 2010 15:29:24 +0100 3690834 http://www.medworm.com/index.php?rid=3687100&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fherbal-remedy-for-uti-if-youre-a-lab-rat-maybe%2F2010.06.22 A patient came into the office the other day carrying a small clipping from a reputable women’s health newsletter touting new research on an herbal remedy for urinary tract infection. Having recurrent bladder infections, my patient naturally was wondering if this was something she should try. The article was entitled “Herbal Remedy Effective for Urinary Tract Infections” and began with this startling revelation: The common herbal extract forskolin can greatly reduce urinary tract infections and could potentially help antibiotics kill the bacteria that cause most bladder infections.  But the article advised that the “popular” remedy was not FDA approved for this indication, so you should “ask your doctor.” (more…) *This blog post was... Better Health blogs http://www.medworm.com/rss/comments.php?id=3687100 Tue, 22 Jun 2010 20:00:00 +0100 3687100 http://www.medworm.com/index.php?rid=3687036&cid=t_355796_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Ffda-approves-hiv-test-earlier-detection%2F The Food and Drug Administration has approved a new blood test for HIV that can detect both antigen and antibody of the HIV organism, thus allowing for earlier detection of the virus after infection. The ARCHITECT HIV Ag/Ab Combo Assay is manufactured by Abbott Laboratory. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3687036 Tue, 22 Jun 2010 19:58:39 +0100 3687036 http://www.medworm.com/index.php?rid=3659156&cid=t_355796_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FavZqNaffZ0g%2F Will another official from the Chinese Food and Drug Administration be executed? The latest scandal involves Zhang Jingli, 55, a deputy director of State Food and Drug Administration since 2003, who is being investigated by the Communist Party of China Central Commission for Discipline Inspection, The Shanghai Daily reports. Jingli was recently dismissed for unspecified disciplinary violations. For those who may not recall, China executed Zheng Xiaoyu, the former head of its FDA, for approving untested medicine in exchange for cash. During his tenure, the agency approved six meds that turned out to be fake, and drugmakers had used falsified documents to apply for approvals (background). After that embarassing episode, China placed its FDA under the jurisidication of the Ministry of Health... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3659156 Mon, 14 Jun 2010 12:36:02 +0100 3659156 http://www.medworm.com/index.php?rid=3644742&cid=t_355796_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F181802%2F FDA Needs To Work on Outbreak Prevention: A new report says that the FDA is struggling to keep food safe, and should focus more of its budget on preventing foodborne illness outbreaks. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3644742 Tue, 08 Jun 2010 20:35:39 +0100 3644742 http://www.medworm.com/index.php?rid=3635744&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnutrition-and-the-government-donuts-for-freedom%2F2010.06.07 An interesting press release from the Competitive Enterprise Institute recently came across our desk and is reproduced in full below. I’m curious what our readers think of it, and of the government’s role in nutritional issues, given the link between nutrition and health: Institute Calls for Civil Disobedience on National Donut Day As Government Meddling in Nutritional Issues Mounts, CEI Advises, “Eat Two Donuts Today—One for Yourself, and One for Your Freedom” Washington, D.C., June 4, 2010 — The Competitive Enterprise Institute today urged Americans to turn National Donut Day into a day of protest against growing government intrusion into nutritional issues. CEI urged people to eat two donuts — “one for yourself, and one as an act of patriotic civil disobedience.�... Better Health blogs http://www.medworm.com/rss/comments.php?id=3635744 Mon, 07 Jun 2010 12:00:00 +0100 3635744 http://www.medworm.com/index.php?rid=3617947&cid=t_355796_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Fjaw-necrosis-and-fosamax-go-hand-in-hand Fosamax, a biophosphonate, is very commonly used for osteoporosis. It works by slowing bone loss and increasing bone mass, and yet did you know that it can cause jaw necrosis? fosamaxThe warning initially had been that cancer patients on the drug were more at risk, but now it seems that if you had recent dental work on infections, you are at a higher risk as well. How can this FDA approved medication be associated with pain, swelling, infection and exposed bone in the jaw? And even though the FDA approved the drug in 1995, it took them until 2008 to issue this statement: “FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the p... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617947 Mon, 31 May 2010 19:48:51 +0100 3617947 http://www.medworm.com/index.php?rid=3617948&cid=t_355796_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Ffda-approved-quinolones-can-cause-severe-disability Quinolones, basically synthetic, broad-spectrum antibiotics, are used to treat almost everything, from urinary tract infections to gynecological infections, STDs, skin infections, and respiratory infection like bronchitis, pneumonia and sinusitis.  And yet, a very well known side effect of quinolones is that it can cause tendon rupture. This can become a huge problem. Quinolones can cause tendon rupture, and someone who is just on treadmill or running while on the medication can tear their Achilles tendon. The recommendation is usually that you don’t run or jog while on the medication. How can we use something that dangerous, like Cipro, so often, when just movement while on the drug can harm you in such a way? But the FDA has known about these effects for a long time. Back in 1995, th... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617948 Mon, 31 May 2010 18:55:41 +0100 3617948 http://www.medworm.com/index.php?rid=3607500&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhave-we-killed-clinical-research%2F2010.05.27 “…I have always depended on the kindness of strangers.”  — Blanche DuBois in Tennessee Williams’ play A Streetcar Named Desire Years ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack. Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial — the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in s... Better Health blogs http://www.medworm.com/rss/comments.php?id=3607500 Thu, 27 May 2010 16:00:00 +0100 3607500 http://www.medworm.com/index.php?rid=3595589&cid=t_355796_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-problem-of-drug-extinction%2F2010.05.24 Doctors are all-familiar with marketing efforts to promote new drugs, but once the new drugs displace older drugs in the medical marketplace, who serves as advocates for the continued manufacturing of older FDA-approved drugs? In a short answer: No one. For those of us dealing in cardiac arrhythmia management, this presents difficult challenges for patient care if people are unable to take the newer drugs due to side effects. These patients no longer have a fall-back option to turn to for medical therapy when the older drugs have become extinct on the marketplace. (more…) *This blog post was originally published at Dr. Wes* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3595589 Mon, 24 May 2010 12:30:00 +0100 3595589 http://www.medworm.com/index.php?rid=3511586&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F28%2Fastrazeneca-settles-case-for-520-million%2F AstraZeneca agreed to a $520 million dollar settlement with the U.S. Department of Justice and a consortium of state Medicaid agencies without admitting any wrongdoing in its marketing of the atypical antipsychotic drug, Seroquel. “AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,” Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners. Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment. The government said the company also paid for ghostwritten journal articles, and marketed the... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3511586 Wed, 28 Apr 2010 14:25:06 +0100 3511586 http://www.medworm.com/index.php?rid=3395247&cid=t_355796_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Fcan-you-really-trust-the-fda-and-pharmaceutical-companies Drugs that give us a quick fix, medications from the drug companies, could be giving us more than we bargained for, as we are learning in the many examples where drug companies are not telling the truth: http://blogs.wsj.com/health/2009/02/26/another-drug-company-accused-of-hiding-negative-study-results/?mod=djemHL The Department of Justice’s complaint against the lab that markets Celexa and Lexapro has once again brought to the forefront that drug companies may be hiding bad results of their medications, while only releasing the better data. I don’t argue that we need drugs sometimes for a quick fix, but in the long run, natural solutions are the only thing that we can trust with our lives. www.clinicaltrials.gov was created to encourage drug companies to be open about their trials, m... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3395247 Tue, 23 Mar 2010 17:28:17 +0100 3395247 http://www.medworm.com/index.php?rid=3314699&cid=t_355796_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fshould-fda-regulate-ehr-safety HHS Secretary Kathleen Sebelius probably wishes she never left Kansas. She’s got one department—the Office of the National Coordinator for HIT (ONC)—that’s passing out HITECH money faster than a street-hawker with peep show tix in order to hasten the dissemination of EHRs. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=3314699 Fri, 26 Feb 2010 20:37:51 +0100 3314699 http://www.medworm.com/index.php?rid=3306839&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FOOTgW1tzEi0%2F Chairman Wu, Congresswomen Edwards and Biggert, and Committee Members. Thank you for this opportunity to testify at this hearing on the National Institute of Standards and Technology. I ask that my written testimony be accepted into the record. Today you will hear from accomplished researchers and leaders in their fields of study from Duke University and Stanford. These individuals are scientists, entrepreneurs and biotechnology innovators. I come here primarily as a mom. I am here today to address the critical link between my experience as a mother striving for treatments, for my kids and millions of others, and the question before this Committee — How our National Institute of Standards and Technology can more effectively influence innovation in life sciences. I begin with a plain ... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3306839 Wed, 24 Feb 2010 21:20:38 +0100 3306839 http://www.medworm.com/index.php?rid=3079384&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F12%2F11%2Ffda-wants-your-comments-on-ect%2F The good folks over at the Committee for Truth in Psychiatry (a national organization for people who’ve had electroconvulsive therapy - ECT) wanted me to remind you that the U.S. Food and Drug Administration (FDA) is seeking comments on the safety and efficacy of electroconvulsive devices. You may not be aware, but these devices — which deliver electrical impulses to your brain! — have never been tested by the FDA for either safety of efficacy. Let me repeat that – the FDA has never approved ECT devices for safety or efficacy. Doctors today can apply electrical impulses to your brain without having any government agency approve such treatment, despite the fact that ECT in most people results in sometimes-significant memory loss. We wrote about FDA’s desire to... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3079384 Fri, 11 Dec 2009 10:35:05 +0100 3079384 http://www.medworm.com/index.php?rid=3075714&cid=t_355796_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F12%2Fthe-fda-and-social-media.html Many of you know that the FDA held public hearings on the pharma industry’s use of Social Media mid-last-month.  There was much excitement going into this because to date, the FDA has pretty much dodged the subject, and left drugmakers in fear of retribution (see BusinessWeek’s summary here). Essentially, since there are no clear rules laid [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=3075714 Thu, 10 Dec 2009 13:00:02 +0100 3075714 http://www.medworm.com/index.php?rid=3039740&cid=t_355796_86_f&fid=38272&url=http%3A%2F%2Flaikaspoetnik.wordpress.com%2F2009%2F11%2F30%2Fcomplementary-medicine-pharmacists%2F I don’t know if the situation is the same in other countries, but in the Netherlands we can only get prescribed medications in pharmacies. Drugstores are only allowed to sell over-the counter (OTC) medicines. Most Pharmacies have a small shop of 5 square meters (besides a large storage room). What surprises me is that the counter [...] (Source: Laika's MedLibLog) Laika's MedLibLog blogs http://www.medworm.com/rss/comments.php?id=3039740 Mon, 30 Nov 2009 03:05:54 +0100 3039740 http://www.medworm.com/index.php?rid=2947145&cid=t_355796_151_f&fid=36896&url=http%3A%2F%2Fsuboxonetalkzone.com%2Fbt.pdf Good Morning Dr. J- I just got off the phone with Roxane Labs, the only approved manufacturer of generic Subutex and the product IS available in all 50 states. It is available to pharmacies and dr offices direct from the manufacturer as well as from all major distributors. There is an ample supply available and is not on back order. Opiate addicts taking Suboxone are hoping for a drop in price with the announcement of new generic medication from Roxane Pharmaceuticals I called around to the major pharmacy chains and all three can order the drug (CVS, Walgreens, and Wal-Mart). None, at least in the Milwaukee area, keep it in stock because of its “orphan drug” status; however most can have it within 24 hours. (Only one of the pharmacists I spoke with actually offered to “pr... Suboxone Talk Zone blogs http://www.medworm.com/rss/comments.php?id=2947145 Fri, 30 Oct 2009 18:50:03 +0100 2947145 http://www.medworm.com/index.php?rid=2927564&cid=t_355796_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfYyJca0pmg8%2F The agency has allowed drugs to remain available even when follow-up studies showed they didn’t save lives, according to a report from the General Accountability Office. And the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such info is more than a decade overdue, the Associated Press reports. FDA officials tell the AP they have no plans to get more aggressive.The FDA responded that the report paints an overly negative picture of its so-called “accelerated approval” program, which is only used to approve drugs for the most serious diseases. “Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments,” the FDA responded. The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2927564 Mon, 26 Oct 2009 12:24:24 +0100 2927564 http://www.medworm.com/index.php?rid=2886649&cid=t_355796_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2FR7LcuCQ5FUE%2F Hereditary angioedema (HAE) is a potentially fatal genetic disorder caused by a deficient or abnormal blood protein called C1 inhibitor. It causes swelling of the extremities, face, trunk, abdomen or airways. Abdominal attacks can result in severe pain, nausea, vomiting, cramps and diarrhea. The attacks can be spontaneous but may also be triggered by stress, surgery or infection. Death may result when the airways close because of the swelling. Only 1 in 50,00 to 150,000 people worldwide/ 1 in 10,000 to 50,000 in the US is affected by this rare dominant mutation, but the mortality is quite high (30%) so it’s really good that the U.S. Food and Drug Administration has approved a treatment Hereditary angioedema. The FDA announced that Berinert has been approved for adults and adolescents wi... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2886649 Tue, 13 Oct 2009 03:58:27 +0100 2886649 http://www.medworm.com/index.php?rid=2832145&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FgSN0QaVCDss%2F Big news: The FDA is holding a public hearing to discuss online promotion of FDA-regulated medical products – including prescription drugs, prescription biologics, and medical devices. The hearing will be November 12 and 13, 2009 in Washington, DC (registration closes October 9 – see also registration instructions from Eye on FDA), but public comments can be submitted in writing or electronically now through February 28, 2010. View the docket details and full Federal Register notice. A common reaction around the Web has been “Finally!” – with remarks like “This is NOT a Hoax!” and “Just in time for Web 3.0,” the FDA has set a date to start figuring out “how to deal with Web 2.0.” (NPR Health Blog). But after the initial shock and sarcas... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=2832145 Thu, 24 Sep 2009 20:24:35 +0100 2832145 http://www.medworm.com/index.php?rid=2724913&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F08%2F21%2Fdubious-blue-light-iphone-app%2F Recently a press release crossed my desk advertising a blue light application for your iPhone (now) and for the Blackberry and Palm soon. I was amazed at the brash medical claims this software maker was claiming — claims that one might think might need to evaluated by the Food and Drug Administration because they relate to the claimed treatment of seasonal depression. What’s so special about blue light? In recent years, there’s been a growing body of research that suggests light in the 460 - 470 nm wavelength spectrum can be particularly effective in helping people with seasonal affective disorder (also called seasonal depression or SAD). It’s also been theorized to help fight fatigue and drowsy driving. But here’s the rub. When you examine those studies, you... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2724913 Fri, 21 Aug 2009 13:15:35 +0100 2724913 http://www.medworm.com/index.php?rid=2613820&cid=t_355796_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FtFN8J64JQs0%2F Yesterday I had the opportunity to moderate a fascinating panel: Drug & Food Safety in the Age of Social Media and Transparency. The panel was part of the Driving the Adoption of Health IT Through Innovations in Social Media conference in Washington DC. There were three panels in all. Mine was the second panel. After opening remarks by Craig Stoltz, Founder of Web 2.Oh…Really (and Former Editorial Director, Revolution Health and Former Editor of the Washington Post Health section), we heard from experts on H1N1 Influenza: How Social Media Improves Communication & Collaboration For Public Health. After my panel, we heard from experts (including Disruptive Woman’s March Man of the Month, Dr. Ted Eytan of Kaiser Permanente) on Electronic Health Records: Using Social Media To Driv... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=2613820 Fri, 17 Jul 2009 20:26:30 +0100 2613820 http://www.medworm.com/index.php?rid=2748160&cid=t_355796_167_f&fid=37833&url=http%3A%2F%2Fnutrition.edublogs.org%2F2009%2F06%2F15%2Fcheerios-a-cholesterol-drug%2F In May the FDA (Food and Drug Administration) sent a warning letter to General Mills, the manufacturers of Cheerios indicating that they had found “serious violations of the Federal Food, Drug, and Cosmetic Act” in that they believe based on the packaging that Cheerios was “is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.” According to the Warning Letter sent by the FDA to Cheerios they were accusing General Mills of marketing an “Unproved New Drug” Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended... Nutrition and Wellness Biology 50 blogs http://www.medworm.com/rss/comments.php?id=2748160 Mon, 15 Jun 2009 18:14:59 +0100 2748160 http://www.medworm.com/index.php?rid=2382872&cid=t_355796_167_f&fid=37833&url=http%3A%2F%2Fnutrition.edublogs.org%2F2009%2F05%2F01%2Ffda-warning-hydroxycut%2F The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products. Linda Katz, M.D. Interim Chief Medical Officer FDA’s Center for Food Safety and Applied Nutrition. I saw an ad for Hydroxycut in a magazine this morning and was wondering about the safety and claims made by the product. Another one of those…”looks too good to be true” and “buyer be ware.” I guess it was only been a matter of time that something would come up. Today the FDA (Food and Drug Administration) issued an official release warning consumers to immediately stop using Hydroxyc... Nutrition and Wellness Biology 50 blogs http://www.medworm.com/rss/comments.php?id=2382872 Fri, 01 May 2009 18:23:33 +0100 2382872 http://www.medworm.com/index.php?rid=2381349&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F01%2Ffriday-flashback-for-may-1-2009%2F It’s Friday, I’m on vacation, so you might as well enjoy these oldies but goodies from years gone by. 10 Years Ago on Psych Central Becoming Stuck Online Ten years ago, I was contemplating my first big career move, leaving a company I had been with for four years in Columbus, Ohio and moving to Austin, Texas to go to work for an Internet startup called drkoop.com. No wonder I was feeling “stuck,” as the job I had created for myself was no longer very challenging (especially with the limited resources I had available versus the rampant resources available to startups). 5 Years Ago on Psych Central J&J Warned on Claims About Antipsychotic Drug In an ominous warning of things to come, the U.S. Food and Drug Administration (FDA) 5 years ago warned the J&J unit... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2381349 Fri, 01 May 2009 09:00:36 +0100 2381349 http://www.medworm.com/index.php?rid=2348546&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F04%2F15%2Fwith-fda-change-ect-may-go-the-way-of-the-dinosaur%2F Last week, the U.S. Food and Drug Administration (FDA) finally decided to start taking action to close a loophole that’s been around nearly as long as the agency itself. Last Wednesday it said that it would require safety and efficacy data from manufacturers of medical devices in 25 different categories. This data is equivalent to the types of data the FDA currently requires for medical devices and drugs — data that shows the device is both safe and effective in use for a prescribed disorder. One of those 25 categories is electroconvulsive therapy (ECT) machines. Yes, you heard right. For decades, the most notorious of all psychiatric treatments available has never met any type of rigorous FDA approval for their use. How can this be? In the case of electroconvulsive therapy ma... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2348546 Wed, 15 Apr 2009 22:51:52 +0100 2348546 http://www.medworm.com/index.php?rid=2287236&cid=t_355796_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F03%2F22%2Fdespite-controversy-lexapro-approved-for-kids-depression%2F Lexapro, an antidepressant already approved to treat major depression in adults, has been approved by the U.S. Food and Drug Administration (FDA) to treat depression in children ages 12 to 17. This happened just weeks after the drug’s marker, Forest Laboratories, was charged by prosecutors of illegally marketing this and another drug (Celexa) to children and paying kickbacks to doctors for prescribing them. Digging into the studies that resulted in the FDA’s approval demonstrates a clearly mixed picture of Lexapro’s effectiveness in children: The FDA on Friday approved Lexapro’s use for adolescents based on favorable results in two clinical trials, one involving adolescents taking Lexapro and another involving children and adolescents taking chemically similar Cele... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2287236 Sun, 22 Mar 2009 16:28:25 +0100 2287236 http://www.medworm.com/index.php?rid=2200623&cid=t_355796_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2F3PfAqxjTbi8%2F The current Obama administration is putting plenty of attention on HEALTH, and I’m not talking about health care and insurance, although hopefully we’ll have good news on those fronts in the next four years. What I’m talking about are money and heads of offices – two factors that dictate how U.S. research in genetics and health will be conducted and approached in the next four years. This week, when President Obama signed the Economic Recovery Act, the NIH got $10 billion in funds for research, medical education and patient care. Another $19 billion went to a health information technology initiative for creating electronic medical records. In the political front, who is going to replace Daschle as candidate for the Health and Human Services Secretary? The Wall Street Journal writ... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2200623 Fri, 20 Feb 2009 05:49:00 +0100 2200623 http://www.medworm.com/index.php?rid=1773570&cid=t_355796_167_f&fid=37833&url=http%3A%2F%2Fnutrition.edublogs.org%2F2008%2F09%2F03%2Firradiating-spinach-and-iceberg-lettuce-to-zap-bacteria-and-extend-shelf-life%2F On August 22, 2008, the Food and Drug Administration (FDA) published a final rule that allows the use of irradiation to make fresh iceberg lettuce and fresh spinach safer and last longer without spoiling. The FDA ruling allows spinach and lettuce sellers to take an extra step, a long-awaited move amid increasing illness outbreaks caused by raw produce. Irradiation has been shown to kill E. coli, salmonella and listeria and lengthen shelf life, without compromising the safety, texture or nutrient value of raw spinach and iceberg lettuce. The FDA is reassuring the public that the process will not make food any less appealing or less healthful than non-irradiated varieties. For More information see the FDA’s website or download a Printer-Friendly PDF File. Sources: FDA. Irradiation: A S... Nutrition and Wellness Biology 50 blogs http://www.medworm.com/rss/comments.php?id=1773570 Thu, 04 Sep 2008 04:33:23 +0100 1773570 http://www.medworm.com/index.php?rid=1660837&cid=t_355796_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F07%2Fis-this-any-way-to-run-regulatory.html The Associated Press recently featured a story on my subject for today which began as follows: "When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot."However, when federal regulators catch a pharmaceutical company marketing prescription medications for an "unapproved" use, it typically takes the U.S. FatalFood and Drug Administration (FDA) an average of 7 months to even issue a warning, and then it typically takes another 4 months for the company to fix the problem.Last year, the FDA took an average of 6 months to issue regulatory letters citing DTC violations, according to Marcia Crosse, who heads the GAO's healthcare division, testifying before a House subcommittee recently. In one case, the agency took more than 3 years to issue a regu... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1660837 Mon, 28 Jul 2008 16:50:00 +0100 1660837 http://www.medworm.com/index.php?rid=1616190&cid=t_355796_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F07%2Flavish-fda-bonuses-go-to-bureaucrats.html You'd think the U.S. FatalFood and Drug Administration (FDA) would be on the mend. After all, last December, The New York Times reported that the FDA is desperately short of money and poorly organized, which is putting people's lives at risk. A report entitled "FDA Science and Mission at Risk", which can be found at the Food and Drug Administration's website, highlights the numerous problems at the FDA.Congress has spent a lot of their time looking at the FDA, and made a number of changes meant to clean things up after more than a decade of mismanagement. As part of these efforts, a while ago, we learned about the FDA handing out $35 million in bonuses under a new incentive plan. FDA Commissioner Andrew von Eschenbach (a very close personal friend of the Bush family) explained that the bon... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1616190 Fri, 11 Jul 2008 14:47:00 +0100 1616190 http://www.medworm.com/index.php?rid=1472692&cid=t_355796_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F299342466%2F Who knew? Seriously, though, a new focus on drug safety is, indeed, delaying the approval of some meds thanks to new requirements meant to minimize side effects, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, confesses to Reuters. The FDA gained new powers in March to require distribution limits or other restrictions on the sale of new meds. “That’s taking a considerable amount of time more for every application. That will go away in time,” she tells the news service. The process, she continues, is adding days or weeks to reviews of drugs that need the additional safety measures. She adds that one of her goals is to direct a “major cultural shift” to emphasize safety. “We have to change…We have gotten that messag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1472692 Wed, 28 May 2008 03:19:47 +0100 1472692 http://www.medworm.com/index.php?rid=1420494&cid=t_355796_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=1391094&cid=t_355796_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F04%2Fwhy-recent-fda-decision-should-have-you.html Today, the Boston Globe reported that the U.S. Food and Drug Administration rejected Genzyme Corp.'s request for permission to sell in the U.S. a version of its Pompe disease (a rare inherited and often fatal disorder that disables the heart and muscles) drug, called Myozyme, the company wanted to make at its Allston, Massachusetts manufacturing plant. Presently, the company can only make this drug at a smaller facility in Framingham, Massachusetts. The FDA ruled that any Myozyme made at the second plant should be considered a different product because of small differences in its chemical structure, and in order to receive FDA approval, the company needs to file another application with new data showing the drug is safe and effective in large numbers of patients. That means costly clinical... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1391094 Tue, 22 Apr 2008 16:00:00 +0100 1391094