FDA acting to remove fraudulent STD products from the market

FDA, FTC act to remove fraudulent STD products from the market

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) today announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs). Among the products targeted in today’s action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak.

The agencies issued multiple letters to companies warning that their products violate federal law. These products, sold online and in retail outlets, have not been evaluated by the FDA for safety and effectiveness. The joint action is the first step in keeping these unproven items from being sold to the public and preventing consumers from being misled.

FDA: Safe Use Initiative

Today, tens of millions of people in the United States depend on prescription and OTC medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, and some die as a result of preventable medication errors. The U.S. Food and Drug Administration (FDA) believes that many of these medication-related risks are manageable if parties committed to the safe use of medications work together.

The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use.

Observational Medical Outcomes Partnership (OMOP)

The Observational Medical Outcomes Partnership: Improving Post-Market Drug Safety

Research Project Aims To Improve Accuracy and Timeliness of Detecting Drug Risks and Benefits in Post-Market Environment

Bethesda, MD (December 6, 2010) - The Foundation for the National Institutes of Health (FNIH) announced the release of the publication "Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership" in the Annals of Internal Medicine. Ann Intern Med November 2, 2010 153:600-606.

The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership composed of representatives from the FDA, academia, 17 corporate and nonprofit organizations in the pharmaceutical industry and health care providers with large health claim or electronic health record databases. The partnership is focused on the need to advance the science of active medical product safety surveillance by using existing health databases.

American Medicine Chest Challenge (AMCC)

AMERICAN MEDICINE CHEST CHALLENGE TO RAISE AWARENESS OF PRESCRIPTION DRUG ABUSE

National Day of Awareness to be Held on November 13, 2010 in Communities throughout Pennsylvania
PENNSYLVANIA – On November 13, 2010, a historic and lifesaving event --- The American Medicine Chest Challenge (AMCC) --- a public health initiative to raise awareness about the dangers of prescription drug abuse will be held in communities throughout Virginia with local law enforcement partnership.

AMCC was created to help American families see their medicine cabinets through new eyes -- as an access point for potential misuse and abuse of over-the-counter and prescription medicine by young people and to provide an opportunity to properly dispose of unused, unwanted, and expired medicines and encourage families to take the five step American Medicine Chest Challenge, explained Angelo M. Valente, Chief Executive Officer of AMCC.

Information on where to dispose of these medicines can be found on americanmedicinechest.com.

PDR Network Delivers Six Million Drug Alerts & REMS

PDR Network Delivers Six Million Drug Alerts & REMS

Electronic Delivery of REMS Fulfills FDA Guidance

MONTVALE, NJ, [October 7, 2010] – PDR Network, already the largest distributor of FDA-approved drug information and Drug Alerts to U.S. prescribers, announced that this month it will surpass six million Drug Alerts and Risk Evaluation and Mitigation Strategies (“REMS”) program alerts delivered to prescribers. FDA-approved Drug-Alerts have been delivered electronically to prescribers by PDR Network’s Health Care Notification Network (HCNN) service since 2008.

REMS programs are becoming increasingly common, and often more complex, for both newly-approved drugs as well as those already on the market. Over 140 drugs now have REMS programs required by the FDA. In some instances the REMS consists largely of an FDA-approved medication guide while in other cases prescribers must take additional training to prescribe the drug. But in every case it is important for prescribers to know the details of the FDA-approved labels and REMS programs, and PDR Network provides this information directly to prescribers online.

Summaries of FDA safety analyses

Here are some snippets from the FDA press release today:

FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA’s website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product’s post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA’s Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

FDA warning: Arrow Brand Medicated Oil & - Embrocation, Aceite Medicinal La Flecha, or “箭嘜驅風油”

The FDA is warning consumers to avoid purchasing or using Arrow Brand Medicated Oil & - Embrocation, Aceite Medicinal La Flecha, or “箭嘜驅風油”

The product is sold primarily on the Internet and in specialty stores that serve Asian and Latino communities.  This product is potentially toxic and contains two substances, methyl salicylate and camphor, which are poisonous when ingested. To learn more, visit the FDA website here.

Suicide risk with Ultram (tramadol) and liver risk with Xenical, Alli (orlistat)

We live in a Phase IV world, don't we? What do I mean by Phase IV? Here's a brief definition from Wikipedia:

Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.

Last week, the FDA announced that Ultram and Ultracet may increase the risk of suicide. The drug tramadol is marketed as Ultram and is included in Ultracet. Tramadol is not an opioid, however it possesses weak agonist actions at the μ-opioid receptor, releases serotonin, and inhibits the reuptake of norepinephrine. Some clinicians seem to think that tramadol may be associated with abuse, misuse, and even possibly addiction. The data remains unclear about that.

The FDA also announced "Rare Cases of Liver Injury Reported with Use of Xenical, Alli." The weight-loss medication orlistat is found in these prescription and over-the-counter agents. Given that the risk of liver injury is rare, the drug is still going to be available but will have a new warning on it. You'll still have the option of buying Alli at your local drug store.

Children's Tylenol, Motrin, Benadryl, and other medicines recalled

Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Following McNeil’s recall announcement on Friday evening, the FDA is providing additional advice to consumers.
 
What products are affected by this recall?
The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. For a complete list of recalled products, please see the recall notice

To learn more, visit the FDA website here.

"Ask the Pharmacist" at Everyday Health

Everyday Health, Inc. recently launched a new service called “Ask a Pharmacist.” This online service puts consumers in touch with licensed pharmacists. Do you have a question about a specific drug? The service is free and questions are generally answered within seventy-two hours of submission. Given that so many patients are taking multiple medications, it's important for consumers to get educated about drug side effects, drug-drug interactions, safety warnings, and updates from the FDA.

“The ‘Ask the Pharmacist’ feature underscores our commitment to delivering new features requested by our users,” says Marjorie Martin. “Drug information is an important content category for our audience and many of our users have questions about proper dosage and potential drug interactions.”

To access the "Ask a Pharmacist" feature, visit the Drugs A-Z section on EverydayHealth.com and you'll have the opportunity to ask a question in the light blue box.

Everyday Health Inc. is a leading provider of online consumer health solutions. The company provides its consumers, advertisers and partners with content and advertising-based services across a broad portfolio of over 25 websites that span the health spectrum – from lifestyle offerings in pregnancy, diet and fitness to in-depth medical content for condition prevention and management. Everyday Health, formerly called Waterfront Media Inc., is headquartered in Brooklyn, NY.

HCNN-PDR drug alert

The Health Care Notification Network (HCNN) has issued a copy of the following "Dear Healthcare Provider" from Genentech:

IMPORTANT SAFETY INFORMATION
Regarding ACTEMRA® (tocilizumab)

The purpose of this letter is to inform you of important safety information for ACTEMRA® (tocilizumab), a new interleukin-6 (IL-6) receptor inhibitor that has been approved by the Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

ACTEMRA targets IL-6. FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ACTEMRA to ensure that the benefits of the drug outweigh the potential risks of serious infections, gastrointestinal perforations, changes in liver function, decreases in peripheral neutrophil counts, decreases in platelet counts, elevations in lipid parameters in peripheral blood, demyelinating disorders and malignancies.

To read the full letter, click here.

Robots in hospitals improving patient safety

I love robots. R2-D2 from Star Wars is my favorite robot. When I retire someday, I'm planning on building a full-size R2-D2 that will move around my house and fetch me my slippers.

We're seeing more robots in the hospitals. Most of these won't be roaming the halls (except for the slow robot that delivers the mail), but quite a few are being used to dispense medications and to perform other tasks in the inpatient setting. A few months ago, Forbes had an article titled, "R2-D2 Has Your Pills." They mentioned how the Robot-Rx (medication-dispensing robot made by McKesson) is being used in a John Muir hospital to reduce medical errors related to drug dispensing. According to that article:

McKesson has installed 400 medicine-dispensing robots at hospitals around the country. They cost between $750,00 and $1 million. McKesson builds the robots at a factory in Pittsburgh, PA. 

Speaking of robots, I'm still waiting to see some iRobot Roomba and Scooba robots in the hospitals. They're great for floor cleaning. Speaking of iRobot, did you know that several members of the management team and Board Members are MIT graduates? No surprise, is it? Sometimes I wonder what my life would have been like had I pursued a career in robotics and biomechanical engineering.

New warning on Plavix (from the FDA)

You've probably heard the news already. You've probably seen the FDA press release. Plavix combined with Prilosec/Prilosec OTC significantly reduces the anti-platelet efficacy of Plavix. For that matter, Plavix combined with any other drugs that inhibit the CYP2C19 enzyme will have significant drug-drug interactions.

Plavix is one of those pills that people take and we don't typically measure or monitor whether the drug is working. It's not like Coumadin (warfarin) where we constantly measure an INR to make sure that your levels are therapeutic. We don't check for peaks of troughs when you're on Plavix. However, perhaps this will change as advances in medical technology make it easier for clinicians to monitor platelet activity in cardiac patients who are taking anti-platelet therapy.

To read the recent FDA news regarding Plavix and Prilosec, click here.

FDA Safe Use Initiative

FDA NEWS RELEASE

For Immediate Release: Nov. 4, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
Agency also releases drug dosage guidance for measuring devices included with OTC medications

The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,” said FDA Commissioner Margaret A. Hamburg, M.D.

Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition.

Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, Md.

As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.

The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.

To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.

The agency also today made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.

The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.

Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”

For more information: http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm

Are generic drugs really equivalent to brand name drugs?

The topic of generics vs. branded drugs is an old debate that still remains somewhat controversial (depending on who you're speaking to). According to the FDA, "An estimated 44 percent of all prescriptions in the United States are filled with generic drugs." This number will only increase as managed care companies try to push more healthcare providers to prescribe generics over branded medications.

The FDA asserts that "generic drugs have the same quality, strength, purity and stability as brand-name drugs." However, we know that recent stories in the news suggesting problems related to quality control of generic drugs. Problems related to generic drugs become popular news stories. Patients often want to take branded drugs. Physicians often prescribe the "latest and greatest" by giving free samples to patients.

At the end of the day, the question regarding generic drugs is rooted in one issue: quality control. When a company submits a generic drug to the FDA, that batch may be a good batch. However, what's to say that future batches will meet the same quality standards? Look at drugs manufactured in China. What type of quality control is going on and how is that monitored?

My family uses generic drugs. We don't take many drugs, but when we need an antihistamine or a proton pump inhibitor, we'll go for the generics. They're inexpensive and they usually work. However, I also believe that the FDA has to improve the monitoring of generic drug quality.

Where's the evidence behind off-label use of drugs?

Depending on your medical specialty, you may write many prescriptions for the off-label use of certain medications. There's nothing illegal about off-label use, but often I wonder: "how strong is the evidence?" The answer really depends on each drug and how it's used.

Many physicians prescribe drugs for off-label use. This happens quite often in the field of oncology because so many clinical studies are exploring various combinations of chemotherapy and targeted biologic agents.

Some patients follow medical news and ask doctors about off-label use when they see something on the news. For instance, some patients have been using certain diabetes drugs like Byetta for weight loss. Did the doctor suggest it, or did the patient do research and ask for it? Byetta isn't indicated for weight loss and it shouldn't be taken lightly because it can lead to some serious problems like pancreatitis.

Do patients really understand the evidence behind off-label use? Insurance companies generally won't pay for drugs that are used off-label, so patients are frequently paying out of their own pockets. Some of these new medications are very expensive, so I often wonder how some people do it.

The FDA is reviewing safety information on Xolair

The FDA has released an Early Communication about an ongoing safety review of Xolair (omalizumab). This is a biologic agent used for the treatment of asthma. Please note that the FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time.

Here's the early communication from the FDA:

Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)

FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group).

Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

The ongoing study, titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5000 Xolair treated patients and a control group of approximately 2500 non-Xolair treated patients. The primary objective of the EXCELS study is to assess the long-term safety profile of Xolair in patients followed for 5 years. Study patients are 12 years of age and older with moderate to severe persistent asthma and who have a positive skin test or blood test for an aeroallergen.

The interim data, submitted by the manufacturer of Xolair (Genentech), suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.

FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA has not made any conclusions regarding these data. The Agency is working with Genentech to obtain further information and will continue to review the strengths and limitations of these interim results. For example, since EXCELS is an observational study, there could be differences in underlying risk factors for cardiovascular and cerebrovascular events between the two study groups. The Agency will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.

The FDA urges both healthcare professionals and patients to report side effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

Let's get the word out to healthcare professionals so that we can see what type of data comes in through MedWatch. I believe that we can improve public health by using social media outlets, including blogs, Twitter, RSS feeds, and forums. Click here to view the FDA early communication about Xolair.

More labeling changes from the FDA: Transplant Drugs

Who's had a kidney transplant? Which immunosuppressant drug are you taking? Here is the latest update from the FDA:

The U.S. Food and Drug Administration (FDA) is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants.

Class labeling changes are required for the following immunosuppressant drugs:

• sirolimus marketed as Rapamune
• cyclosporine marketed as Sandimmune and generics
• cyclosporine modified marketed as Neoral and generics
• mycophenolate mofetil marketed as Cellcept and generics
• mycophenolic acid marketed as Myfortic

The FDA conducted analyses of its Adverse Event Reporting System (AERS) to characterize the association between BK virus-associated nephropathy and the use of these immunosuppressant drugs. The occurrence of BK virus-associated nephropathy is primarily observed in renal transplant patients.

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.

The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for Prograf. Currently the prescribing information for the other immunosuppressant drugs does not adequately warn about this possible serious adverse event. Based on this new safety information, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that manufacturers of these immunosuppressants update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy

This information reflects FDA’s current analysis of data available to FDA concerning these products. FDA intends to update this document when additional information or analyses become available.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this sheet.

Information about the increased risk for opportunistic infections already is included in the labeling of the immunosuppressive drug Prograf (tacrolimus).

So who markets these drugs? Do you know?

• Rapamune (sirolimus) is marketed by Wyeth.
• Sandimmune (cyclosporine) is marketed by Novartis.
• Neoral (cyclosporine modified) is marketed by Novartis.
• Cellcept (mycophenolate mofetil) is marketed by Roche.
• Myfortic (mycophenolic acid) is marketed by Novartis.
• Prograf (tacrolimus) is marketed by Astellas.

To read the FDA alert, click here.

Grand Rounds July 14, 2009: Technology and Healthcare

Welcome to Grand Rounds Vol. 5 No. 43 @ Medicine & Technology. The theme is this week is to look at different ways technology is changing the world of healthcare. I am your host this week and I hope you'll enjoy some of these interesting stories.

To start things off, we see Marya (Healthcare, etc.) talking about patient rights and the potential effects of false positive results. This may lead to unnecessary tests and/or medications and possibly even some invasive procedures. Do we really need to biopsy every small incidentaloma that appears on imaging studies? Perhaps as diagnostic testing improves over time, we will have fewer false positives.

Ramona (Suture for a Living) reminds us that we must not Forget HIPAA Privacy Rules as we continue to expand the use of electronic health records (EHRs). We know that EHR adoption will increase rapidly over the next several years as billions of dollars get channeled from the government.

Jolie (I am Dr. Jolie Bookspan, The Fitness Fixer) describes some of the high-tech things she got to do as a military research scientist. I wonder what those pilots experience as they go through acceleration testing and undergo serious g-force effects.

Bongi (other things amanzi) writes about a funny story that happened during his Saturday rounds when his boss focused on clothes and not on anyone's morning breath (improved breathalyzers in the future should pick up faint signals of ETOH during morning rounds).

Alison (Shoot Up or Put Up) talks how the internet has provided her with some useful tips to help her live with diabetes. The web is full of both reliable and unreliable health information for patients. Even healthcare professional sometimes get misguided by the information that can be found online.

Ryan (ACP Internist) shares an awesome acronym of the week: SHUTi, a new Internet program that shows promise for helping people get to sleep. Can stories, quizzes and games really teach people to have better sleep habits? Let's see.

Hank (InsureBlog) talks about how some patients are cleaning up their own hospital rooms. Perhaps once we have some fully-automated cleaning robots, we should be free of that problem. We just need iRobot to make make some hospital-grade Roomba and Scooba cleaning robots.

Nancy (Teen Health 411) writes about an exciting electronic Wellness Assessment for Youth - called WAY2GO! that's coming to We're Talking Teen Health at the Palo Alto Medical Foundation (PAMF). Thanks to a partnership between the Health Trust, Vive, and PAMF, teens will be able to get a personalized health report back with links to a new service providing free personal health coaching via the web and their cell phones.

Sam (Canadian Medicine) writes about Dr. Bob Thirsk, a Canadian physician who is living on the International Space Station. What's he doing up there? Providing medical care for his fellow astronauts and operating the Canadarm2. I'd love to head out to space some day.

Jay (Colorado Health Insurance Insider) suggests that change in protocol for breech births may actually benefit mothers, babies, and health insurance companies. Is it possible that surgical technology has made it too convenient to opt for a C-section? What if we performed fewer C-sections?

Dr. Charles (The Examining Room of Dr. Charles) writes about the low-tech importance of empathy in taking a family history, and the precarious control of emotions that is needed in being a good listener. What does that look like? A level-headed, composed and somewhat thoughtful response.

OTW (On The Wards) writes how the increasing prevalence of drug-resistant bacteria is generating a need for newer weapons against infectious diseases. Why do we have all these superbugs? Are healthcare professionals too eager to prescribe antibiotics? Let's hope some advances in drug development will lead to more effective therapies against these multi-drug-resistant organisms.

Clinical Cases (Clinical Cases and Images - Blog) writes about ways to improve medical RSS aggregators. Do you even know what RSS stands for? What about Web 2.0? Speaking of RSS and Web 2.0, do you Twitter? Make sure to follow interesting medical bloggers on Twitter. You can start by following me @DrJosephKim

Allergy Notes (Allergy Notes) talks about one of my favorite topics: chocolate. Or, actually, chocolate allergies. I think if I ever developed that, I'd be taking Benadryl all the time. It's hard for me to imagine a life without chocolate. I could live without many things, but I'd really miss chocolate. If I developed a chocolate allergy that resulted in anaphylaxis, I'd probably go through several epi-pens each day.

Murali (SharpBrains) discusses the Pros and Cons of the most common assessments to identify cognitive problems, introducing the opportunity presented by innovative computerized neuropsychological tests. I think I'd prefer going through a battery of assessment tests over a brain biopsy. How about you?

Barb (Florencedotcom) writes about the well-known IT caveat "garbage in-garbage out," and what it means since the medication use system we rely on is rife with failure points. I haven't thought about GIGO in a very long time. We definitely need more drug safety specialists to help prevent medication errors. Computerized Prescriber Order Entry (CPOE) may reduce some errors, but it won't eliminate all of them.

In a guest post, Michael (Health Business Blog) talks about how Dr. Francis Collins (nominated as the head of the NIH) is getting a bum rap. What do you think about the Human Genome Project? I think it's rather amazing to see how far we've come in human genomic science.

The Samurai Radiologist (The Samurai Radiologist) asks: Which background music/sound is optimal for cognitive activities such as film interpretation? A quick and dirty study while on call suggests classical music. Bach, to be precise. In my former life, I used to play the oboe (but I wasn't one of those crazy, fanatical oboe players).

Randel (Disruptive Women in Health Care) blogs about the medical device industry, particularly the “use (or underuse)” of technology as it relates to what she describes as an “arcane” payment system. Although comparative effectiveness research must be used to test new medical technology, reform in the payment system is equally necessary.

Jan (Doc Gurley, Posts From An Insane Healthcare System) covers new information about the placebo effect, including a hierarchy of results (did you know big pills work better than small ones?). In her article, she also points out that positively reinforcing a result makes it more likely to happen. So does this mean all those TV and internet drug adds are boosting a drug's efficacy?

David (HealthBlawg :: David Harlow’s Health Care Law Blog) spoke with Prof. Rodwin about his proposal that all de-identified health data be subject to public ownership, so that private companies cannot restrict access to it and/or monetize it. Public ownership would ensure availability of data for comprehensive public health and evidence-based medicine uses.

Chris (Life in the Fast Lane) offers some pointers to help ‘Web 2.0 laggards’ pull their heads out of the ground and off-load the stress of information overload. Fear of information overload is a barrier preventing doctors from using web resources. But, given that humanity has been experiencing information overload since the invention of the Gutenberg press, ignoring web resources to avoid confronting this daunting problem is a maladaptive, self-defeating strategy.

Well, that wraps it up for this week. Thanks for attending Grand Rounds here at Medicine and Technology. And next week, head over to our surprise, last-minute guest host's site: www.docgurley.com (Doc Gurley, Posts From An Insane Healthcare System), for details on how you can submit. In addition to hosting Grand Rounds, Doc Gurley also will be, that same weekend, speaking at the Mystery Writer's conference in Marin about death, mayhem and the urban underside of life. If you're looking for inspiration, or a theme for Grand Rounds' July 21 submissions, the code word for next week's Grand Rounds is...mystery! Get your submission in early and win big Big BIG karma points! [AND, if you're a San Francisco Bay Area health blogger, send an email to Doc Gurley at docgurley (at) gmail (dot) com for details about the first ever health bloggers' meet-and-greet - ALSO on July 21!]

10 Xanax pills a night?

How does 10 Xanax pills a night sound? Not too bad if you're down from 30-40 pills.