Saturday, July 18, 2009

Pregnancy and H1N1

If you're pregnant, make sure you watch this CNN video about H1N1 (swine flu)

Friday, July 17, 2009

Fake NASA moon landings?


There is a medical component to this question. Some who argue that the Apollo moon landings were fake say that the Apollo astronauts would have been poisoned by passing through the Van Allen radiation belts that ring the Earth. NASA argues that the astronauts passed through the Van Allen belts too quickly to be exposed to dangerous levels of radiation. I suppose you can think of it like this: Fire is dangerous. However, if you pass your hand quickly over the flame, then you won't get harmed. According to Wikipedia, the Van Allen radiation belt is a torus of energetic charged particles (plasma) around Earth, which is held in place by Earth's magnetic field. The belts are a hazard for artificial satellites and moderately dangerous for human beings, difficult and expensive to shield against.

It's interesting to see that some people strongly believe that the moon landings were fake. Modern special effects are so advanced that we could probably fake a lot of things today. We didn't have CGI graphics in 1969.

So what do you think? Do you believe in the conspiracy theory? (You must love the X-files. My wife loves the X-files.)

Speaking of NASA, do you know about the Aerospace Medical Association? If you've ever wanted to go into space, maybe you'll get your chance if you pursue a career in aerospace medicine. Read an interesting story on CNN about the moon landings here.

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.

How can social media improve public health?


If I were back in school getting my MPH, I think I'd do my thesis on the topic of how social media can improve public health. I admit that I'm an early adopter and I love technology. As I see how consumers are embracing various social media outlets, I see a tremendous potential to improve public health through these different channels. The combination of health IT plus social media may revolutionize the world of healthcare if we recognize the potential and map out an appropriate strategy that utilizes all the major resources.

For instance, we know that consumers love to read blogs. Certain healthcare professionals also like to follow blogs. Blogs can be used to deliver key public health messages to the public.

In addition to blogs, we have tools like Twitter. Many bloggers use Twitter as a broadcast medium and I often wonder if Twitter will evolve and eventually replace traditional RSS feeds. Tweets that get retweeted can spread like a virus and circle around the planet faster than a viral email campaign. Did you know that the FDA, CDC, NIH, HHS, and WHO all have Twitter accounts?

Finally, we have social networking sites like Facebook, LinkedIn, Plaxo, and others. These social networking sites can be powerfully leveraged to communicate important public health messages.

So, whether you're talking about a swine flu pandemic alert, an FDA drug recall, a food alert, a drug safety alert, or any other type of public health alert, the use of social media combined with health IT resources will be an effective way to improve public health if the right people jump onboard and plan things appropriately.

Doctor's can't say "no"


It's strange, but true. Doctors have such a difficult time saying "no" to patients. Look at our famous deceased celebrity. CNN is reporting that some physicians simply couldn't say no to him. As a result, he had an anesthesiologist put him to sleep each night and then wake him up each morning. Talk about an interesting moonlighting gig! Can you imagine the conversation the next morning?

Q: "So, what did you do last night?"
A: "Oh, I put Michael Jackson to sleep..."

Why do doctors have such a hard time saying no? Whether it's about antibiotics or controlled substances, so many physicians don't wish to spend extra time to explain why the answer is no. Instead, it's so much easier (and much faster) to say yes. If you want to increase your revenues and see more patients, then you're going to say yes more often than no. Read the CNN story here.

Thursday, July 16, 2009

FDA Approves Onsolis (fentanyl buccal soluble film)


The FDA approved Onsolis (fentanyl buccal soluble film) with a Risk Evaluation and Mitigation Strategy (REMS). Fentanyl is the most "potent" opioid and is subject to abuse, misuse, and diversion.
Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth’s mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use. “Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER). “For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.”

As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients’ homes.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

In February, the FDA announced that it would require a REMS for a different class of opioids that offer long-acting and extended-release medication. The FDA has held a series of meetings with stakeholders, including a large public meeting, and also solicited written public comments to hear more about how to develop this REMS.

“The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products,” said Douglas Throckmorton, M.D., deputy director of CDER. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.”

Onsolis is manufactured by Aveva Drug Delivery Systems, Miramar, Fla., and marketed under license from BioDelivery Sciences International Inc. of Raleigh, N.C., by Meda Pharmaceuticals Inc., based in Somerset, N.J.
Glad to see that cancer patients now have another option to help them with pain control. Tolerance to opioids is a common problem. As you increase on dosage and give more opioids, the side effects (such as constipation) can become very problematic. Fortunately, there's a drug approved by the FDA for opioid-induced constipation or OIC. It's called Relistor (methylnaltrexone) and it's made by Wyeth.

Stimulus 103: Real World Perspectives


If you missed the AMA webinar titled, "Stimulus 103: Real World Perspectives," then you may be glad to know that you can view the archived session here: www.ama-assn.org/go/hit and then look under "Health IT webinars." Or, you can click on this direct link: https://cc.readytalk.com/play?id=8qo7xu

This is the 3rd part to the American Recovery and Reinvestment Act (ARRA) webinar series by the AMA. The presenters include:
  • Amanda Ervin, Director of Health Information Technology Initiatives, AMA
  • Gary S. Schenk, Sr., MD, Gaston Family Care, Gastonia, NC
The agenda includes the following topics:
  • Update on meaningful use
  • Small practice perception of meaningful use as it pertains to utilization of an EHR
Seems like we're getting closer to really understanding and defining "meaningful use." The Health IT Policy Committee's "meaningful use" work group will meet today in Washington to submit revised recommendations to Dr. David Blumenthal, the National Coordinator for Health Information Technology. The next HIT policy committee meeting is scheduled for August 14.

FDA Peanut Product Recall Widget

Here's an interesting FDA widget: Peanut Product Recall Widget

FDA Product Recall List


FDA Salmonella Typhimurium Outbreak 2009. Flash Player 9 is required.FDA Peanut Product Recall Widget. Flash Player 9 is required. Visit http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm to search for peanut product recalls or call CDC-INFO at 1-800-232-4636 for more information.

Nursing Informatics at the Point of Care: A Barrier or a Bridge?


If you're interested in this topic, then perhaps you'll want to attend SINI 2009. This is the theme this year for the Summer Institute in Nursing Informatics. Informatics at the Point of Care: A Barrier or a Bridge?

SINI 2009 is July 22-25 at the University of Maryland School of Nursing. Can't get to Baltimore? Then you can still participate in the plenary presentations and concurrent sessions by registering for the Web-streamed program. Web participants receive all the conference materials and can participate in discussions via email.

Featured speakers this year include:
* Keynote – James J. Cimino, MD, National Institutes of Health
* Paul Tang, MD, Palo Alto Medical Foundation
* Marcelline Harris, PhD, RN, Mayo Clinic
* Nancy Staggers, PhD, RN, University of Utah
* End Note – Suzanne Bakken, DNSc, RN, Columbia University
Wish to learn more? Then visit: http://nursing.umaryland.edu/sini

Healthcare in rural areas and the impact of reform

Have you ever lived in a rural area? When I was a medical student, I had the chance to spend a summer in a rural area that was filled with poverty. In fact, it was one of those "lowest-income counties" in the U.S. As we undergo healthcare reform, how will these changes impact those who live in rural areas?

Wednesday, July 15, 2009

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.

Why physicians will always lose the reimbursement game


Got another e-mail from Sermo's founder Daniel Palestrant, MD. This one was titled, "Why physicians will always lose the reimbursement game." If you're interested in seeing the contents of this letter, then you'll have to get on Sermo (which is currently only available for U.S. physicians).

If you've been following the news, you know that the House Democrats recently unveiled a massive health care reform plan. According to CNN, "House Democrats unveiled their revised version of health care reform Tuesday, offering a proposal that includes a government-funded health insurance option, requires both individuals and employers to participate, and taxes the wealthy to help cover costs... Democratic House leaders said the measure, titled "America's Affordable Health Choices Act," met the requirements set by President Obama for health care reform by lowering costs to consumers and businesses, letting people keep their current plan if desired, and preventing denial of coverage due to pre-existing medical conditions."

Specific provisions of the bill include:
-- A Health Insurance Exchange providing individuals and small business with choices for coverage, including a government-funded public option.

-- No more coverage exclusion for pre-existing conditions.

-- Affordability credits for low- and moderate-income individuals and families, available to those with incomes up to 400 percent of the federal poverty level, or $43,000 for individuals and $88,000 for a family of four.

-- Limits on annual out-of-pocket spending.

-- Expanded Medicaid coverage to individuals and families with incomes at or below 133 percent of the federal poverty level.

-- Required participation by individuals, with a penalty of 2.5 percent of adjusted gross income for non-compliance.

-- Requirement that businesses with payrolls exceeding $250,000 provide their employees with health coverage or contribute up to 8 percent of their payroll on their behalf.

-- A series of measures intended to reduce costs of Medicaid, Medicare and other existing systems.
So how will these changes impact physician reimbursement? If we're trying to cut costs in healthcare, then it seems only logical that we'll be cutting some costs in physician reimbursement (although this may impact certain specialties more than others). Will physicians choose to transition into non-clinical areas and leave clinical medicine? Read the CNN article here.

Stem cell therapy out of a James Bond movie


I'm reminded of a James Bond movie where a certain "health clinic" in Cuba offers gene therapy (among other things) that would probably never be allowed in the U.S.

According to CNN, Dr. Zannos Grekos has a company in the Dominican Republic called Regenocyte Therapeutic. He claims that he has successfully used adult stem cells to treat patients with heart and lung disease. Hmm, I wonder what else he's up to. Stem cell therapy mixed with some gene therapy to change people's faces and appearances? I wonder if he's using any special face lamps...

Here are some interesting snippets from the CNN story:
Dr. Irving Weissman, president-elect of the International Society for Stem Cell Research, told CNN, "There is no such cell. There is nothing called a 'regenocyte.' " "As a stem cell scientist who works in the field of regenerative stem cells, I am disappointed and shocked that somebody would prey on a family that has an untreatable disease with the promise of a therapy that has no scientific or medical basis," Weissman said.

Grekos (a cardiologist) has a busy practice in Bonita Springs, Florida, outside Naples, and runs a company that promotes and administers stem cell therapies in Santiago, a noisy, crowded industrial city in the central Dominican Republic.

A year ago, Barbara McKean of Naples, Florida, paid Regenocyte Therapeutic more than $54,000 for stem cell therapy in the Dominican Republic after suffering from chronic lung disease. She said she believes the therapy was worth the expense.
So, are you willing to be part of a private research project? I suppose the villains in the James Bond movie had no choice. Did you guess the James Bond movie? Die Another Day. Maybe if we start seeing some high-profile officials (drug lords) visit the Dominican Republic for "medical care," then we'll have a really interesting medical clinic to investigate. Until then, we have to wait to see what type of data can be generated from this interesting practice. To read the CNN story, click here.

Health IT and Social Media


Have you had a chance to explore Ozmosis yet? Like Sermo, Ozmosis is an online community of U.S. physicians.

Ozmosis is co-hosting a Symposium on Thursday, July 16th entitled, "Driving Health IT Through Innovations in Social Media." They have a group of speakers from the CDC, FDA, HHS, NIH and the private sector who will demonstrate the success of and lessons learned from existing social media programs in the federal, state and private health sectors. Here are the details:
Thursday, July 16, 2009 (8:00am - 11:45 am)

Amplify Public Affairs
919 18th Street, NW
10th Floor
Washington, DC
This event is hosted by these groups:
  • Amplify Public Affairs is the next generation in public affairs, leading the way in the integration of new media and traditional communications strategies.
  • Clinovations is an organization dedicated to providing advisory services and management consulting to healthcare delivery systems, national associations and government organizations.
  • Ozmosis, the Trusted Physician's Network, is the professional application of a social network that enables verified, U.S. licensed physicians to exchange medical knowledge.
Visit: http://www.socialmediahit.com

Treating multiple myeloma when the patient is a Jehovah's Witness


During medical school, we're often faced with clinical case vignettes where we get to practice problem solving skills. Such cases also often involve issues surrounding medical ethics. Anytime you get a case where the patient is a Jehovah's Witness, you know you'll be dealing with something ethical (that probably involves blood transfusions).
According to Wikipedia, "Jehovah's Witnesses are not permitted to accept red cells, white cells, platelets or plasma, though they may accept fractions made from these components at their own discretion."
How do you treat a patient who has multiple myeloma if that individual requires blood transfusions but refuses? This is being discussed on Sermo by various oncology physicians. It's a very difficult situation because what is medically necessary isn't an option if the patient competently refuses that treatment. Will a combination of various anti-cancer drugs (such as Thalomid or thalidomide, Velcade or bortezomib, and Revlimid or lenalidomide) and growth factors (such as Procrit or epoetin alfa and Aranesp or darbepoetin alfa) help an individual who has progressed so far in this illness? Or, are such strategies medically futile?

I think one of the most difficult things to face is a dying patient who refuses medical care. It's more than a mental exercise. When you know that you can do something to help that person and that person is willfully refusing (it may be for a variety of reasons), that just becomes a very challenging situation. Alternative medical options may be futile. Do you try them anyways? Sometimes there are no practical options that won't endanger the patient further. You can't just walk out or abandon that type of patient. Do you suggest hospice? At what point do you discontinue futile efforts?

Association for Clinical Researchers and Educators (ACRE)


There's a new association that combines the focus on clinical research and education. It's called the "Association for Clinical Researchers and Educators (ACRE)."
Association of Clinical Researchers and Educators (ACRE) is an organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts. ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration. In addition, ACRE will identify and train next generation of researchers and educators.
To learn more about this group, visit the website: http://www.acreonline.org/

Tuesday, July 14, 2009

Prescription drug abuse - who's fault is it?


CNN has a story about prescription drug abuse because a recent celebrity (I think we all know who) may have had some problems related to pain pills and sedatives. The story starts with this line:
People who abuse prescription drugs often do so believing the pills are safe because they are prescribed by doctors and approved by the Food and Drug Administration, addiction experts tell CNN.
When we look at the recent statistics, we realize that this is a huge problem:
In 2005, non-medical use of painkillers contributed to more than 8,500 deaths. Overdose deaths involving prescription pain relievers increased 114 percent from 2001 to 2005.
Perhaps the media is to blame? Do you feel that celebrity death stories (related to drug abuse) have been glamorized in any way? We all know that many celebrities have problems with substance abuse. How does that get portrayed to young people living in America?
By 2008, according to the Drug Enforcement Administration's Web site, 38 states had passed legislation to create a database for physicians and pharmacists to prevent abusers from obtaining multiple prescriptions.
Many drug addicts are very sophisticated and they have developed clever schemes to beat the system. Some have multiple identities. Others cross state lines and they eventually learn where they can go for their drugs.

So who's to blame for this drug abuse problem? The doctor? The patient? The drug company? The FDA? Or "all of the above"? What can be done to alleviate this common problem? Certain patients refuse to take controlled substances because they fear addiction. Some physicians
To read the story, click here.

18th Annual Physician-Computer Connection Symposium


The Association of Medical Directors of Information Systems (AMDIS) is kicking off its "18th Annual Physician-Computer Connection (PCC) Symposium" today. Here are the details:
Ojai Valley Inn
Ojai , California
July 14 - 17, 2009
Target Audience: Physicians, CMOs, CMIOs, CIOs, Healthcare Executives, Nurses, Clinicians, Vendors and Consultants.

International Virtual Medical School or IVIMEDS


Have you heard of the International Virtual Medical School or IVIMEDS? Sounds like an interesting concept, doesn't it?

The International Virtual Medical School - IVIMEDS
- is a worldwide partnership of leading edge medical schools and institutions, setting new standards in medical education and blending high quality e-learning and face-to-face learning in the training of health care professionals.

The IVIMEDS Principles include:

  • The use of world class learning materials accessed and shared among leading international medical schools and institutions.
  • Flexibility in choice of content and learning strategies and the ability to customise content to meet specific needs of teachers, doctors and students wherever they are located.
  • Technical interoperability and standards maximising the scope for international collaboration and flexibility of delivery methods
IVIMEDS is an international not-for-profit partnership of medical schools and institutions working to develop the full potential of e-learning in medical education. In partnership with its members IVIMEDS aims to provide an effective means of developing and sharing a range of quality digital learning resources and value-added educational services across the continuum of education. Primary development efforts are focussed on the undergraduate medical curriculum, though strategic opportunities for developments at postgraduate and continuing professional development level are being explored.

E-learning technologies are changing the landscape of medical education. Students today have access to such a wide range of multimedia, simulators, and other innovative tools that can significantly enhance their education. I envy modern-day medical students (and even college students for that matter). I didn't use a tablet PC to write notes using different colored pens when I was a student. I didn't have access to rich multimedia simulations.

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!]

Monday, July 13, 2009

Inovio Biomedical H1N1 DNA Vaccines


Here's an interesting heading: "Inovio Biomedical H1N1 Influenza DNA Vaccines Demonstrate 100% Responses Against Swine Flu in Vaccinated Pigs." I realize that we're not pigs, but this vaccine may be quite effective in humans too. Here are some interesting bits from a recent press release:
Dr. Niranjan Sardesai, Senior VP, Research & Development, presented the data at the Annual Conference of DNA Vaccines in Asia 2009 held in Beijing, China, July 9-10, 2009, in a presentation entitled, “Pandemic and Seasonal Influenza DNA Vaccines Delivered Via Electroporation.”

Dr. J. Joseph Kim, Inovio’s CEO, said, “Our innovative SynCon™ technology has the potential to protect people from influenza strains not exactly like the ones that make up the existing vaccines. This is a clear advantage for our universal flu program over conventional influenza vaccines. We are pleased to report our H1N1 preclinical results using pigs, a more natural model for the current influenza pandemic. We look forward to advancing our SynCon™ universal flu vaccine program toward clinical investigation.”

In this study, scientists immunized pigs with consensus H1N1 influenza DNA vaccine candidates on day 0, day 14, and day 28. Sera collected on day 28 and day 42, after two or three doses of vaccine, respectively, showed hemagglutination inhibition (HI) titers above the protection threshold in 100% of the vaccinated animals against a swine H1N1 virus previously isolated from pigs. On-going additional animal studies are testing the ability of Inovio’s SynCon™ human H1N1 and swine H1N1 based vaccines to cross-protect from currently circulating human and swine H1N1 viruses as well as the new influenza A/H1N1 of swine origin.

In a similar collaborative study with scientists from the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania, Inovio previously demonstrated that mice immunized with Inovio’s SynCon™ H1N1 DNA vaccine provided 100% protection in a lethal challenge study against an unmatched H1N1 virus that caused the 1918 Spanish flu, which killed over 40 million people worldwide.

Inovio’s novel SynCon™ technology enables the company to design DNA-based vaccines with the potential to protect against unmatched sub-types and strains of pathogens. Inovio has created SynCon™ DNA vaccines based on influenza HA, NA, and NP proteins that are common to strains H1N1, H2N2, H3N2, and H5N1, which make up the majority of seasonal and pandemic influenza. Using a designer approach, Inovio can formulate these DNA plasmids together to rapidly develop a universal influenza vaccine potentially targeting all these strains. The resulting vaccine could target seasonal as well as pandemic-potential influenza strains such as avian influenza and swine flu, which has already been designated pandemic status. Significantly, being based on a common set of antigens derived from a broad range of flu strains, such a universal vaccine would have the potential to provide greater protection against evolving, unmatched flu strains.
The fall is quickly approaching. Let's hope that we have enough H1N1 vaccine to go around the world so that we don't suffer mass fatalities from this swine flu pandemic.

Live Webinar Tomorrow: The Great HIT Debate


Tomorrow (Tuesday, July 14, 2009) from 12:30-2:00PM (EST), HCPLive.com blogger and author of the MDNG column "HIT Realist" Alberto Borges, MD, will debate Joseph Kvedar, MD, director of the Center for Connected Health. Topics up for discussion include the HITECH Act incentives and their likely effect on health IT adoption, the problem of "usability" and where it fits in with the push for "certified EHRs," the use of health IT to improve quality and patient safety, and more.

There will be a Q&A session after the debate when registered attendees can ask questions.

Register today at: https://www1.gotomeeting.com/register/646034233

Alberto Borges, MD
Dr. Borges is the author of the "HIT Realist" column, which appears monthly in MDNG, as well as an accompanying blog on HCPLive.com. He is also an active blogger and participant in many online discussions on the careful and cautious implementation of health IT. In addition, Dr. Borges is a private practitioner in the Washington, DC area and an assistant clinical professor of medicine at The George Washington University School of Medicine and Health Sciences in Washington, DC.

Joseph Kvedar, MD
Dr. Kvedar is the Founder and Director of the Center for Connected Health, a division of Partners Healthcare that is applying communications technology and online resources to increase access and improve the delivery of quality medical services and patient care outside of the traditional medical setting. The term "connected health" reflects the range of opportunities for technology-enabled care programs and the potential for new strategies in healthcare delivery. Dr. Kvedar is internationally recognized for his leadership and vision in the field of connected health and the application of communications technologies to improve healthcare for patients. Dr. Kvedar is co-editor of the book, Home Telehealth: Connecting Care within the Community, the first book to report on the application of technology to deliver quality healthcare in the home.

Medtronic recalls certain Paradigm® Quick-Set® Infusion Sets


If you have diabetes and you're using a Medtronic MiniMed Paradigm insulin pump, you'll want to read this:

According to the FDA, Medtronic, Inc. has initiated a voluntary recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly.
Patients should discontinue using “Lot 8” Quick-set infusion sets.
Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge. To view the entire FDA press release, click here.

Dr. Regina Benjamin as the next U.S. surgeon general


Sounds like Dr. Regina Benjamin will be our next surgeon general. CNN's Sanjay Gupta turned down the offer.

Dr. Regina Benjamin is founder and CEO of Bayou La Batre Rural Health Clinic, Bayou La Batre, Alabama. She is also the first African American woman to become president of the state medical society of Alabama. She is former associate dean for rural health at the University of South Alabama's College of Medicine in Mobile, where she administers the Alabama AHEC (Area Health Education Centers) program and previously directed its Telemedicine Program. In 1998 she was the United States' recipient of the Nelson Mandela Award for Health and Human Rights. In 1995 she was elected to the American Medical Association's (AMA) board of trustees, making her the first physician under age 40 and the first African-American woman to be elected. She has also served as president of the American Medical Association's Education and Research Foundation. That's quite a long list of some of her major accomplishments! Congratulations to Dr. Benjamin!

Expand your online social network


On my other blog: NonClinicalJobs.com I often write about the importance of social networking. One of my recent posts was titled: Join me on LinkedIn, Twitter, and Ning

After publishing that post, my network on LinkedIn and Twitter grew significantly. I now have over 15,000 thousand followers on Twitter! I only had about 50 followers back in April! In roughly 3 months, I gained 15,000 new followers!

Social networking is so important in this day in age, especially if you're looking for a new job or a complete career change. If you're a healthcare professional and you're considering a career change into the non-clinical world of medicine, I hope you'll follow my blog: NonClinicalJobs.com

CMS rating hospitals based on readmission


The Centers for Medicare and Medicaid Services (CMS) is now rating hospitals based on readmission data and mortality. Should healthcare providers get rated based on readmission statistics? New ratings on 4,000 hospitals will show up on the CMS "Hospital Compare" Web site which can be found at: http://www.hospitalcompare.hhs.gov
CMS officials have suggested that readmission data - how frequently patients return to a hospital after being discharged - may be "a possible indicator of how well the facility did the first time around. Readmission rates will help consumers identify those providers in the community who are furnishing high-value healthcare with the best results."
As physicians, we are pushed to get patients out of the hospital quickly. Now, any patient who "bouces back" will harm our reputation. Is that fair? What about those non-compliant patients who refuse to adhere to their medication regimens? They are likely to "bounce back" if they get discharged on many critical meds and never fill their prescriptions. Maybe healthcare providers will be more motivated to fire these types patients. If that happens, then no one may want to care for them.

CMS has been tracking the outcomes of hospital care since 2007 when the "Hospital Compare" website provided 30-day mortality rates for heart attack and heart failure.

Sunday, July 12, 2009

A cheerful heart is good medicine


I was reminded today that "A cheerful heart is good medicine, but a crushed spirit dries up the bones." This comes from Proverbs 17:22 (which is in the Bible).

You may have also heard of it like this: "A joyful heart is good medicine, but a broken spirit dries up the bones." or "A glad heart makes a healthy body, but a crushed spirit makes the bones dry." or "A merry heart doeth good like a medicine: but a broken spirit drieth the bones."

So what's the bottom line here? Do our attitudes really impact our health and well being? Perhaps this is one of the reasons why the placebo effect is so powerful (it may not be ethical, but it is powerful).

Medicine and Technology: Top posts for last week

Here are the most popular posts from the previous week on MedicineandTechnology.com
  1. Is Canada's health system better?

  2. Things are getting ugly between Sermo and the AMA

  3. Some of the Top 10 Health Experts on Twitter

  4. Sermo's founder Dr. Daniel Palestrant on video

  5. Survival tips for new interns: eating

  6. CMS proposes 21.5% reduction in Medicare payments

  7. Ethics of concierge medicine

  8. Jobs for Physicians with No Residency Experience

  9. Concept of "overweight" may be relative

  10. Understanding the Medicare e-Prescribing Incentive Program