Happy Independence Day America!

Today is July 4 and it marks Independence Day in the United States. Our country has changed dramatically since 9-11 and I think Independence Day has a revived meaning in this country. As we combat terrorism and fight for freedom, let us continue to pray for our soldiers and their families.

Survival tips for new interns: eating

Since we're in the month of July, I thought I'd share some "survival tips for new interns." If you're a medical student and you're starting your 3rd year clinical clerkships, these same tips may help you survive on the wards. Since the number seven is symbolic of completion, I'll provide 7 tips:

1. Eat whenever you can and always carry snack bars. Sometimes, you're running around like crazy. Your cafeteria might close and you'll miss dinner. It's essential that you eat whenever you can and always carry survival food. Ration that food since you won't know when you'll get to restock your supplies.
2. Keep food in your bag/locker at all times. See above.
   
3. This is not a good time to go on a diet. See above. You may be prone to some serious rebound eating phenomenons.
4. Keep some new, clean zip lock bags in your white coat pocket. You'll never know when you'll be around free food that you can't eat (but you might be able to stuff a cookie into that bag and run along).
   
5. If you're about to die of hunger, offer to buy some snacks for everyone instead of asking, "can I go and eat while the rest of you continue to work?"
   
6. If you carry food in your pockets, avoid things that can melt, get crushed, or leak. I love chocolate, but it can melt and be messy to eat. Chips are great if you like salty crumbs. I love ice cream bars, but not after they've been in my pockets for 2 hrs.
7. If you get really desperate (last resort), you can always play the "I think I gave myself too much insulin and I'm starting to feel hypoglycemic" card. Remember, you don't have to disclose anything about your personal health conditions.
   

Remember the "Symptoms of Inadequate Food Consumption" (according to SurvivalTopics.com - feel free to quote that website):

• Irritability
• Low moral
• Lethargy
• Physical Weakness
• Confusion and disorientation
• Poor judgment
• Weakened immune system
• Inability to maintain body temperature which can lead to hypothermia, heat exhaustion, or even heat stroke.

So, you don't want to blame any of these things listed above to "inadequate food consumption," right? You definitely don't want to exhibit "poor judgment" because of an empty stomach.

My next series of survival tips will be on bathroom use. Here's a preview: always empty your bladder before you perform a paracentesis on a patient with cirrhosis and massive ascites.

Understanding the Medicare e-Prescribing Incentive Program

Do you understand the Medicare e-Prescribing Incentive Program? Don't get this confused with the incentives outlined in ARRA about HITECH. Sorry, let me clarify: The Medicare e-Prescribing Incentive Program is not the same as the recent incentives outlined in the Health Information Technology (HITECH) provisions within the American Recovery and Reinvestment Act (ARRA).

The Medicare e-Prescribing Incentive Program began January 1, 2009 and provides incentives for eligible healthcare professionals who are "successful e-prescribers". We'll define that later. Section 132 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) authorizes a new and separate incentive program for eligible professionals who are successful electronic prescribers (e-Prescribers) as defined by MIPPA. For 2009, e-prescribing incentive amounts will be 2% of the total estimated allowed charges for professional services covered by Medicare Part B and furnished by an eligible professional during the reporting period (one calendar year). 2% may not seem like much, but it can add up quickly.

Previously, there used to be an e-prescribing quality measure that was included in the Physician Quality Reporting Initiative (PQRI). Now, e-prescribing is no longer included in PQRI and it is the quality measure used in the E-prescribing Incentive Program.

One question that often gets asked about the Medicare e-Prescribing Incentive Program is this: "What defines a "qualified' e-prescribing system?" If you're using an EHR that has some type of e-prescribing capability, are you using a "qualified" e-prescribing system?

According to Medicare, there are two types of e-prescribing systems:

• 1) a system for e-prescribing only (a “stand-alone” system), or
• 2) an electronic health record (EHR) system with e-prescribing functionality.

Either of these systems may be used for the incentive program, as long as they are “qualified.” Let's talk about that word now. A qualified system must be able to do the following:

1. Generate a complete medication list that incorporates data from pharmacies and benefit managers (if available)
2. Select medications, transmit prescriptions electronically using the applicable standards, and warn the prescriber of possible undesirable or unsafe situations
   
3. Provide information on lower-cost, therapeutically-appropriate alternatives (for 2009, tiered formulary information, if available, meets this requirement)
   
4. Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient’s drug plan

So, are you using a "qualified" e-prescribing system? If you're not, then you're missing out on some Medicare incentives.

Hospital worker may have exposed patients to hepatitis C

This is a very sad and disturbing story. A surgical technician has at Rose Medical Center in Denver has admitted to secretly injecting herself in a bathroom and using unclean syringes as replacements for patients. Kristen Diane Parker had hepatitis C, presumably from IV drug use, and she took patient fentanyl injections and replaced them with saline. She worked at Rose from October 2008 to April 2009. So far, nine patients who had surgery there during that time have tested positive for hepatitis C. That is really a shame. Parker should have gotten professional help for her drug addiction. Now, Parker is in federal custody facing three drug-related charges. If she is found to have done serious harm to a patient, she could face up to 20 years in prison. If a patient dies due to her actions, she could face life in prison.

According to CNN, in a statement to police, Parker said, "I can't take back what I did, but I will have to live with it for the rest of my life, and so does everyone else." Rose Medical Center is contacting 4,700 patients who had surgery at Rose during the time Parker was employed there. Another 1,200 patients may have been infected between May 4, 2009, and July 1, 2009, when Parker worked at Audubon Ambulatory Surgical Center in Colorado Springs.

Hepatitis C can be treated, but the treatment regimen isn't easy to take. Advances in antiviral therapies have improved outcomes for hepatitis C and several new and novel agents are in development. Advances in drug development may lead to a quick and easy cure for hepatitis C. Wouldn't that be nice? I know many people who are infected with hepatitis C due to blood transfusions. We (as the medical community) didn't know how to identify hepatitis C before 1992. It was called non-A, non-B viral hepatitis. We now call it hepatitis C. Chronic infection can lead to cirrhosis and liver failure. It can even lead to liver cancer. To read the CNN story, click here.

Contest eaters face serious health issues

In a former life, I was almost a contest eater. Not for speed, but for quantity. That was a very long time ago. Do you ever watch those food eating contests? They are crazy! CNN has a story titled, "Speed eaters gain weight, clog arteries but have few regrets." Maybe they don't have many regrets while they're still young and relatively healthy, but this type of behavior can catch up to you, especially if you're Don Lerman who set a record by eating seven sticks of salted butter in five minutes. During six years of competitive eating, he gained 100 pounds! The average adult in the U.S. gains 1 pound per year. If you gain 100 pounds in 6 years, how many pounds are you gaining each year? (certainly you're above the mean)

In 2007, University of Pennsylvania School of Medicine doctors who specialize in gastroenterology and radiology conducted an experiment on the stomach activities of a competitive eater and an average eater. Do you know what they found? Competitive eaters lacked muscle contractions called peristalsis, which move the food down the digestive tract. The researchers published a paper where they warned about: possible "morbid obesity, profound gastroparesis, intractable nausea and vomiting, and even the need for a gastrectomy." Yikes!

I wonder what we're going to learn about competitive eaters over the next decade. If you exercise, can you eat anything you want to eat? Does exercise give you freedom to eat? (It does for me - that's why I can enjoy ice cream and be guilt-free). Read the CNN story here.

Tip for medical students, interns, and residents

Here's my tip of the day: sew a few pockets inside your white coat. If your white coat already has inside pockets, then you're all set! However, some of you may only have pockets on the outside. If that's the case, then spend some time (or money) to attach pockets to the inside. Why do I think this is useful? If you're a medical student or intern, you'll be carrying around so many papers (and supplies during your surgery rotation) that you won't want everything bulging out on the outside. You can hide some of those items on the inside (and also have better access to urgent items).

Once you're a resident, you may have lighter pockets, but here's where you can also have the chance to carry some items that may be life-saving. When's the last time you carried a Sengstaken-Blakemore tube during your GI/Hepatology rotation? These things can be life-saving (and you won't have time to wait for one if you really need it).

Medicare Part D increases spending on prescription drugs

Is that what you were expecting? In a recent article in the New England Journal of Medicine (NEJM), we see that the authors conclude that "Enrollment in Medicare Part D was associated with increased spending on prescription drugs. Groups that had no or minimal drug coverage before the implementation of Part D had reductions in other medical spending that approximately offset the increased spending on drugs, but medical spending increased in the group that had more generous previous coverage."

Between December 2005 and December 2007, as compared with the increase in the no-cap group, the increase in total monthly drug spending was $41 higher among enrollees with no previous drug coverage, $27 higher among those with a previous $150 quarterly cap, and $13 higher among those with a previous $350 cap. I wonder if the government knew this was going to happen.

The article is titled, "The Effect of Medicare Part D on Drug and Medical Spending." Click here to access the abstract. The authors on this study included: Yuting Zhang, Ph.D., Julie M. Donohue, Ph.D., Judith R. Lave, Ph.D., Gerald O'Donnell, M.S., and Joseph P. Newhouse, Ph.D.

Ethics of concierge medicine

Concierge medicine is often referred to as boutique or retainer-based medical practices. We have seen a surge of physicians and medical groups converting to this type of model over the last several years. Why? Because you can get paid more for seeing fewer patients. Sounds almost ironic, doesn't it? In a typical concierge practice model, patients pay an annual retainer fee outside of insurance to gain greater access to their physician. What does this mean? It means that you may be able to call your doctor directly. Forget about answering services. Also, it may mean that you doctor will see you in the middle of the night if you develop chest pain. Forget waiting in the ER if you need to get admitted by your physician.

If political leaders like presidents can have concierge-type medical care, then is it unethical to offer it to other rich and powerful people? If a billionaire hires you to live and work as a personal doctor for his/her family, would it be unethical to do that? I think the bigger issue revolves around the accessibility to care. If you're the only doctor in a 50 mile radius and you decide to convert your practice, then there may be some ethical issues concerning the accessibility to care and medical need. A related topic deals with the acceptance of Medicaid insurance. Many physicians are choosing not to accept Medicaid because the reimbursement is so low. Eventually, a cash-only model may become the prominent model (especially if the government steps in and offers some level of universal health coverage).

Let's evaluate the ethics behind concierge medicine:

• Autonomy: Probably not an issue.
  
• Beneficence: "the act of doing good things." Well, as long as you offer good care to those who are paying you, you're fine there.
• Non-Maleficence: "do no harm." Well, this is where concierge medicine may have a problem. If you move to a brand new area to set up your concierge medical care, then you may be fine. However, as I mentioned above, if you're the only doctor in a remote area and you decide to convert your practice, then there may be some ethical issues concerning the accessibility to care and medical need. You may be "harming" those who are unable to afford your prices.
  
• Informed consent: Don't see any issues here as long as your contract is well-written.
• Confidentiality: Probably not an issue.

The AMA Principles of Medical Ethics ends with this statement: "A physician shall support access to medical care for all people." Hmm, not sure how this relates to concierge medicine.

However, the AMA Principles of Medical Ethics also has this statement: "A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care."

Healthcare Information Technology Standards Panel

Have you heard of the Healthcare Information Technology Standards Panel (HITSP)?

Let me share a snippet from their "about us" section of their website: "The mission of the Healthcare Information Technology Standards Panel is to serve as a cooperative partnership between the public and private sectors for the purpose of achieving a widely accepted and useful set of standards specifically to enable and support widespread interoperability among healthcare software applications, as they will interact in a local, regional and national health information network for the United States... The Panel's work is driven by a series of priorities (i.e., Use Cases) issued by the American Health Information Community (AHIC). HITSP produces recommendations and reports in Interoperability Specifications and related Constructs. These work products are intended to be equally applicable to the developing Nationwide Health Information Network for the United States (NHIN) and also to community and regional health information exchange networks."

OK, if that didn't impress you, then maybe this will: "HITSP is a strategic partnership established through a contract with the U.S. Department of Health and Human Services."

On July 9, The Healthcare Information Technology Standards Panel (HITSP) is identifying the standards that will support the exchange of healthcare information across the United States. Titled, "Health Information Exchange (HIEs) in the Real World," this webinar will cover how HITSP products are being used today by the New England Healthcare EDI Network (NEHEN), Keystone Health Information Exchange (KeyHIE), and Vermont Information Technology Leaders, Inc. (VITL). Interested in this free webinar? Click here for more information.

The HITSP is administered by the American National Standards Institute (ANSI) in cooperation with strategic partners including the Healthcare Information and Management Systems Society (HIMSS), the Advanced Technology Institute (ATI), and Booz Allen Hamilton.

NPR: Young Doctors Weigh In On Health Care

I want to thank my friend Roland for pointing me to this link. There's an interesting NPR segment titled, "Young Doctors Weigh In On Health Care." Here's the description of the clip:

"Two young doctors, just finishing up their residencies, discuss the decisions behind their career choices. Nicole Loeding is going into primary care, while Brian Southern, after becoming disillusioned with primary care, has chosen pulmonary critical care."

How do medical students choose their specialties? Why do some decide to pursue a career in primary care? As we go through healthcare reform, will the interest in primary care increase or decrease? Will more physicians choose to leave clinical practice to pursue non-clinical careers?

The 8 minute NPR segment is interesting, but perhaps what's more interesting are the 12 comments that discuss physician salaries. So how much do primary care doctors make? It really depends on your geography and your patient volume. To access the NPR segment, click here.

E. coli in beef leading to hospitalizations

MSNBC is reporting that at least 12 hospitalizations have occurred due to E. coli contamination in beef. Some of these patients have even suffered kidney failure. According to the Centers for Disease Control and Prevention (CDC), at least 23 people in nine states may have become ill after eating beef produced by JBS Swift Beef Co. of Greeley, Colo. I think it's time to make sure my beef is cooked well-done for a while. Forget eating medium-rare or even medium steaks. To read the full story on MSNBC, click here.

Reducing cell phone radiation exposure

Technology Review - I love that magazine. It's published by MIT and I just got my copy today because I'm on the MIT alumni mailing list. On the Tech Review blog, there's a post titled, "How to Reduce Cell-Phone Radiation Exposure." The author writes that a new network architecture could dramatically reduce the radiation exposure from cell phones. Wouldn't it be great if we could reduce radiation and boost battery life? What if we could enhance existing networks by adding large numbers of base stations that only receive signals and are connected up to the rest of the network via a landline or a line-of-sight microwave link? There's an Israeli startup called Greenair Wireless and that's what they're trying to do. What's the big deal about radiation exposure? Chronic exposure to radiation may be linked to a higher risk of cancer. So do cell phones cause brain cancer? It's still a controversial topic and I don't think we'll have a clear answer for a while. In the meanwhile, anything that we can do to reduce that exposure would be warmly welcomed by all of us who are now so dependent on mobile phones and smartphones.

FDA Approves Multaq (dronedarone) to Treat Heart Rhythm Disorder

This is straight from the FDA RSS feed:

FDA Approves Multaq to Treat Heart Rhythm Disorder.

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug’s label will contain a boxed warning, the FDA’s strongest warning, cautioning that the drug should not be used in severe heart failure patients.

“Multaq represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

In a multinational clinical trial with more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with an inactive pill (placebo). Most of that effect represents reduced hospitalizations, especially hospitalizations related to atrial fibrillation. Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength. Multaq is manufactured by Paris-based sanofi-aventis.

So, let's talk about this for a few minutes. Dronedarone is a brand new drug and it may replace the use of amiodarone in many patients who have afib. Atrial fibrillation is a common condition that you get to manage in the hospital setting. It's not a lot of fun if you have to run around to titrate Cardizem drips all day. Amiodarone is associated with some significant toxicities, including pulmonary toxicity leading to interstitial pneumonitis and other lung problems. It's great to see that we have other alternatives for patients with afib. Speaking of afib, medical students often like to use a mnemonic to help them remember the different causes of afib:

PIRATES:

• Pulmonary: PE, COPD
• Iatrogenic
• Rheumatic heart: mirtral regurgitation
• Atherosclerotic: MI, CAD
• Thyroid: hyperthyroid
• Endocarditis
• Sick sinus syndrome

Inovio developing a swine flu vaccine

Inovio is developing a swine flu vaccine. Here's the headline: "Inovio Biomedical, National Microbiology Laboratory, and University of Pennsylvania to Evaluate Candidate DNA Vaccines Against “Swine” Influenza A (H1N1)"

Inovio has established a new collaboration with the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania to further evaluate Inovio DNA vaccine candidates against swine influenza A (H1N1) virus. Dr. J. Joseph Kim (no, that's not me), Inovio’s CEO, stated, “The current swine flu outbreak highlights the fact that the world cannot rely solely on the “catch-up” strategy of influenza vaccine design. We need vaccines that provide at least some broad protective capability against evolving seasonal influenza strains and those with pandemic potential. We have already achieved significant validating data in large animal models regarding the ability of Inovio’s consensus vaccines to protect against unmatched strains of different influenza sub-types and look forward to the data resulting from this collaboration of vaccine experts.”

Mississippi tops U.S. obesity rankings

The state of Mississippi tops U.S. obesity rankings according to CNN. In fact, it's held this title for the 5th year in a row - for both adults and children. 32.5% are obese in Mississippi. In addition, 44.4 percent of Mississippi children ages 10 to 17 are classified as overweight or obese, the study found. This is a serious public health problem and the state of Mississippi desperately needs help to control this obesity epidemic. Unfortunately, Southern style cooking is often rooted in deep fried foods, so it's going to be very difficult to change cooking patterns that are deeply ingrained in Southern culture. Obesity is linked to a variety of health problems such as diabetes, heart disease, and hypertension. Many people who are obese really struggle to lose weight and keep it off. So what's the solution? Bariatric surgery?

This is where preventive medicine needs to take a very active role. Educational efforts alone are not enough. Interventions must begin in the classroom as children learn and develop lifestyle habits. Unless things change at a fundamental level, the problem will only continue to get worse. Perhaps the government needs to channel some money into structured weight loss programs. People living below the poverty line probably can't afford to pay for Weight Watchers or Jenny Craig. They also can't afford expensive gym memberships. They are often eating unhealthy foods and they often lack access to exercise facilities. To read the entire CNN story, click here.

How much swine flu vaccine will we need?

How much is enough? That's the question of the year as we prepare for the worst part of the swine flu pandemic. We know that swine flu (influenza H1N1) has spread throughout the U.S. and healthy people are dying from this common illness.

CNN has a story titled, "CDC: U.S. may need 600 million swine flu vaccine doses." Is 600 million doses going to be enough? What if we need more? Each adult will probably need two separate doses of vaccine (two shots, ouch!). According to CNN, "Congress passed a supplemental appropriation for $7.5 billion, which President Obama recently signed, to cover the costs of preparing for the virus, which includes a vaccination campaign." New and old pharmaceutical companies around the world are racing to prepare a safe and effective swine flu vaccine. Will they be prepared before it's too late? What if they're not safe? These are some of the questions that health officials are facing. To read the CNN story, click here.

Are you avoiding the hospitals because of new interns and residents?

July is when new interns and residents begin working in teaching hospitals. Fresh medical school graduates now get to wear long white coats (at least in most hospitals) and go around being called "doctor." No longer are they fourth year medical students. No longer do they have those short white coats. No longer do they need to find someone to sign a prescription. They have the power to write prescriptions (at least is most states) and they also have the power to control medical students (well, let's not get on this right now).

So, are you avoiding the hospital because these fresh interns are getting acclimated and oriented? How would you feel if your "doctor" has only been a doctor for a few days?

Well, I suppose if you're sick, you really don't have any choice. Perhaps you'll want to go to a private hospital and avoid teaching institutions. If you do that, how will these students and doctors-in-training learn anything?

Do you know how to differentiate an intern from a resident? Some hospitals use different white coats (or they place a "mark" on the intern coat). If you see a young-looking doctor wearing a brand long new white coat, you may wonder, "how new is that long white coat?"

Misguided health article on CNN about CRP

CNN has a story that has a misguided title (in my opinion). The story is titled, "Study suggests C-reactive protein doesn't cause heart disease." If we focus on causality, we may be missing the boat.

C-reactive protein (CRP) may not cause heart disease, but it may be a marker of underlying inflammation. Chronic inflammation may lead to coronary heart disease (CHD). If that's all true, then the title of the story can be misguiding. We often think in terms of cause and effect. If you have blood stasis (not moving), then you can form a blood clot. Cause and effect. So, if cardiovascular inflammation causes CHD, can you have inflammation without an elevation in CRP? Can you also develop CHD without any inflammation if you also have really high cholesterol levels? I think we're learning that the pathophysiology of CHD is not as simple as we learned about in medical school.

Well, if CRP doesn't cause heart disease, so what? What if CRP is an indicator of heart disease? That's the real question. It may not have a causal relationship, but that statement may be misguiding.

The JUPITER study published in the New England Journal of Medicine (NEJM) showed that a cholesterol-lowering drug Crestor (rosuvastatin) significantly reduced the incidence of major cardiovascular events in healthy-appearing patients who had low and normal cholesterol levels. This was such a groundbreaking study that it stirred significant controversy about CRP and the high-sensitivity CRP (hs-CRP).

CNN quotes the lead author of the JUPITER study in this story as "Another leading CRP researcher who isn't so sure about the findings published in the Journal of the American Medical Association (JAMA)." Dr. Paul M. Ridker, the director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital, in Boston, Massachusetts, said: "A null Mendelian randomization may not mean very much... While it does not support causality, I don't think most genetic statisticians believe it excludes a causal pathway either."

Are you familiar with Mendelian Randomization and Genetic Association Studies? Good, me too. The JAMA studied used this as one of its steps: " A mendelian randomization study for the most associated single-nucleotide polymorphism (SNP) in the CRP locus in our data together with published data on CRP variants with CHD let us assess the potential causal association of CRP with CHD." Did you catch all that? Good, me too.

Dr. Ridker argues that clinicians should still measure hs-CRP for the following reasons:

• A, it predicts vascular risk even when cholesterol is low and other risk factors are absent, and,
  
• B, because we have clinical trial data demonstrating that if you have an increased level of [hs-CRP], you will live longer and have fewer heart attacks and strokes if you take a statin.

Dr. Ridker goes on to say: "I have always felt that CRP is a good clinical biomarker of inflammation (and high vascular risk) but that it is inflammation that is likely to be causal for atherosclerosis, not CRP itself." To read the CNN story, click here.

CCHIT Unveils New Paths to Certification

Is your electronic health record (EHR) system certified by the CCHIT?

The CCHIT (Certification Commission for Healthcare Information Technology) now offers three different certification approaches to replace the current single one. According to Mark Leavitt, M.D., Ph.D., Commission chair, “The rate of EHR adoption must now be tripled to meet the ambitious ARRA (American Recovery and Reinvestment Act) timelines, so we’re broadening access to certification, widening our previous single-lane road to the equivalent of a three-lane freeway... We need to serve a more diverse spectrum of providers and offer a wider range of EHR technology options from which to choose.”

The three different approaches are:

• A rigorous certification for comprehensive EHR systems that significantly exceed minimum Federal standards requirements. This certification (EHR-C) would be targeted to the needs of providers who want maximal assurance of EHR capabilities and compliance

• A new, modular certification program for electronic prescribing, personal health records, registries, and other technologies. Focusing on basic compliance with Federal standards and security, the EHR-M program would be offered at lower cost, and could accommodate a wide variety of specialties, settings, and technologies. It would appeal to providers who prefer to combine technologies from multiple certified sources.

• A simplified, low cost site-level certification. This program would enable providers who self-develop or assemble EHRs from noncertified sources to also qualify for the ARRA incentives.

Development of the new certification options is scheduled to begin in this month (July).

FDA: Boxed warning for Chantix and Zyban

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDA press release has this comment from Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research: “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking... Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Wellbutrin (another branded name of bupropion) and generic versions of bupropion will also require this warning. Chantix is marketed by Pfizer and Zyban is marketed by GlaxoSmithKline (GSK). Before we know it, every drug out there will have a black box warning and people might simply start to ignore them. Will we soon need another form of a boxed warning?

Medicine and Technology: Top posts for June 2009

Here are the most popular posts for the month of June 2009 on MedicineandTechnology.com

1. Jobs for Physicians with No Residency Experience

2. Sermo vs. Ozmosis: Physician Social Networking

3. A free EMR Solution?

4. What happens if you eat magnets?

5. Medical Software for the BlackBerry Storm

6. Non-Clinical Careers and Opportunities for Physicians

7. How Do You Calculate GFR?

8. Do You Have Cell Phone Elbow?

9. Twitter Growth: the Last 2 Months

10. Epic MyChart

Government panel may pull drugs containing acetaminophen

A government panel assembled by the FDA may make some recommendations to pull some very common medications off the shelf. Acetaminophen (common brand name Tylenol) is a very safe drug that is mainly used to treat pain and fevers. However, an overdose of Tylenol can also be lethal because it can destroy the liver. We can live without our spleen, but we can't live without our liver, so that's why a Tylenol overdose can be fatal. Some people die as they wait for a liver transplant.

According to CNN (quoting the FDA), "overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s." Of course, we also know that millions of people safely use Tylenol without any problems. The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness. This includes common drugs like: NyQuil, Pamprin and Allerest. Does this just mean that consumers will learn how to use over-the-counter drugs for off-label purposes? The FDA doesn't have to follow the advisory panel recommendation, so when this is all over, it may all be meaningless.

CNN also reports that the Consumer Healthcare Products Association (CHPA) strongly opposes the elimination of OTC (over-the-counter) acetaminophen containing combination products. Interesting? Click here to read the CNN story.

Does Lantus (insulin glargine) increase the risk of breast cancer?

We've seen some troubling information emerge in the world about diabetes. We now have controversy regarding the saftey of Lantus (insulin glargine). With the heading, "Lantus insulin: a possible link with cancer which requires further investigation," we see a press release from Diabetologia titled, "Possible link between insulin glargine and cancer prompts urgent call for more research." The next line says: "But experts stress patients should not stop using insulin and consult their doctor if concerned."

The press release starts with: "The European Association for the Study of Diabetes (EASD) today makes an urgent call for more research into a possible link between use of insulin glargine (an insulin analogue, brand name Lantus) and increased risk of cancer, following evidence from studies in Germany, Sweden and Scotland. However, until this further research becomes available, these experts are stressing that patients with diabetes taking Lantus should continue to do so, although some might wish to consider alternative types of insulin. The studies are reported in Diabetologia (the journal of EASD)."

What were the findings? "Professor Edwin Gale, Editor of Diabetologia, and Professor Ulf Smith, President of EASD, realised the significance of these findings but wanted them replicated in other studies from other European countries before announcing them formally. Studies were thus carried out using databases from Sweden, Scotland, and the UK.

• The Swedish study found that compared with patients on insulins other than Lantus insulin, patients on lantus insulin alone had double the risk of breast cancer.
  
• The Scottish study found a non-significant increased risk for breast cancer specifically.
  
• The UK study found no link between insulin glargine and cancer."

Yet these studies have some significant limitations:

• Although the data were adjusted for a number of variables, the characteristics of the groups of patients taking lantus insulin alone (generally older, higher blood pressure, more overweight) were different to those on other forms of insulin. Thus any difference in cancer risk could be attributed to the pre-treatment characteristics of the groups, rather than the treatment itself.
• The numbers of cases of breast cancer in the Swedish and Scottish studies were very small, meaning the findings could have occurred due to chance.

So, how does that make you feel? Maybe if you're Swedish or Scottish, you may feel concerned. If you're British, you may feel relieved. Sounds silly, doesn't it? When we have conflicting data, the topic becomes a controversy. We have no causal data. We have no consensus statements. We have no definitive stances from major diabetes associations. What does the American Diabetes Association (ADA) have to say about this? We don't know yet. Hence, we now have a controversial topic on our hands. The investigators recognize that this is a controversy and they stress (once again) "that patients should not stop using insulin and consult their doctor if concerned."

The EASD released a statement, which reads: "These studies are described and commented on in greater detail in the webcast by Professor Ulf Smith (University of Göteborg, Sweden), and Professor Edwin Gale (University of Bristol, UK). EASD emphasises that the studies reported are far from conclusive, but they do indicate the need for further investigation of this issue..."

To read the full press release on Diabetologia, click here.

Does your doctor Twitter?

Does your doctor use Twitter? Does he/she even know what Twitter is? American Medical News has a story titled, "Twitter: What's the use? Early physician adopters say the social media site can help you promote your practice and communicate with colleagues." The story quotes a "Dr. Kim" but that's not me - it's Peter Beck Kim, MD (@doccottle), a family physician in Costa Mesa, Calif. I'm @DrJosephKim on Twitter.

Can Twitter actually promote your medical practice? How many doctors are using Twitter to communicate with their patients and to market their website? Twitter is a very powerful social media tool because it provides instant results. You can't say that about most blogs. The American Medical News story quotes data that the Nielsen Co. released in April which found that only about 40% of users were active a month after creating an account. Physicians are busy enough that most don't want to bother with social media unless some type of monetary incentive is provided (like market research surveys).

Among physicians, you have the early adopters who love technology and they are actively engaged in Web 2.0 technologies (ranging from blogs, RSS feeds, forums, wikis, and social networking tools like Twitter). If you're looking for such early adopters, look on Sermo and on Medpedia. That's where you're likely to find people who even understand the basics of social networking. Of course, you'll also find many physicians who work in the business side of healthcare - consulting, pharma, managed care, medical communications, and so on. These individuals appreciate the importance of networking for both personal and professional purposes.

Was Michael Jackson's death preventable?

So many people are speculating about what caused Michael Jackson's death. Was it due to drugs? Drug abuse? Prescription drug interactions? Did he have a bad heart? If toxicology tests are going to take six to eight weeks (according to Ed Winter, assistant chief coroner for Los Angeles County), then we have plenty of time to speculate and throw ideas around. Will we discover the truth, or will it be hidden from the public?

A recent article in CNN talks about the possibility of drug interactions rooted in prescription opioid medications such as OxyContin and Demerol. Was Jackson in denial about potential drug problems? Demerol can have significant drug-drug interactions and cause serious problems. It's often used to treat patients who present to the emergency room for acute pancreatitis (in reality, almost any opioid will work to relieve pain, but demerol is used in "classic textbook cases." I won't go into the sphincter of Oddi right now). In a highly visible case, 18-year-old Libby Zion died in a New York hospital in 1984 presumably because of drug-drug interactions.

So, was Jackson's death a preventable death? If it was due to drug-drug interactions that could have been avoided, perhaps his story will serve as a public health campaign. To view the CNN article, click here. Image source: CNN

Using a Tablet PC in healthcare

Do you use a Tablet PC? If you don't, consider this: Why use a tablet PC in the medical world?

Dr. Oz on Forbes - headaches about resveratrol

There's a story on Forbes titled, "A Headache for Dr. Oz." Poor Dr. Oz. Forbes says, "The celebrity surgeon's endorsement of a longevity pill has sparked a ragtag industry of dubious sellers - starring Dr. Oz."

He's a celebrity because of Oprah, but now it seems like he's facing many headaches about resveratrol. Maybe it's just one major headache. Dr. Oz talked up the antiaging properties of resveratrol and now many companies are using his name and photo to promote resveratrol. The problem is that some (actualy, many) of these companies appear to be questionable at best. They have been reported to the Better Business Bureau and have been rated with an "F" plus over two thousand customer complaints.

Resveratrol is not a miracle drug. It is still being researched (see Harvard Researcher and the Secret of Aging). Don't buy it on the Internet (or anywhere else) - we still need more information about this agent. This post is not meant to be interpreted as medical advice. It's meant to protect you from the Internet scams that are out there regarding the use of resveratrol pills, creams, and other anti-aging products.

Nanotechnology expert wins Lemelson-MIT Prize

Congratulations to Professor Chad Mirkin, director of Northwestern University's International Institute for Nanotechnology. He won the 2009 Lemelson-MIT Prize ($500,000) for innovations that have the potential to transform the future of medical diagnostics and patient point-of-care and to ignite change across many industries from semi-conductors to healthcare. So can you get rich by staying in academia? Sure, just go out and win half a million dollars!

Here are a few snippets from the MIT News: "Mirkin is best known for the invention, development and commercialization of two technologies: the nanoparticle-based medical diagnostic assays underlying the FDA-approved Verigene ID(tm) system and Dip-Pen Nanolithography (DPN), an ultra high-resolution molecule-based printing technique. Both inventions were born, in part, out of Northwestern's Nanoscale Science and Engineering Center, funded by the National Science Foundation, and conceived, managed and directed by Mirkin."

The Lemelson-MIT Program recognizes outstanding inventors, encourages sustainable new solutions to real-world problems, and enables and inspires young people to pursue creative lives and careers through invention. Jerome H. Lemelson, one of U.S. history's most prolific inventors, and his wife, Dorothy, founded the Lemelson-MIT Program at MIT in 1994. It is funded by The Lemelson Foundation. The Foundation's programs in the U.S and developing countries recognize and celebrate accomplished inventors; provide financial and mentoring support to grassroots inventors; offer hands-on opportunities that enable young people to develop their budding scientific curiosity; and disseminate technologies that improve people's lives.

FDA confirms E. coli O157:H7 in prepackaged Nestlé toll house refrigerated cookie dough

The title says it all: "FDA confirms E. coli O157:H7 in prepackaged Nestlé toll house refrigerated cookie dough"

Stay current with all the FDA alerts by following the FDA on Twitter:

• http://twitter.com/FDARecalls

E. coli comes in many forms, but 0157:H7 is a really bad form (you don't want to experience 0157:H7).

Transparency and the government

These days, the word "transparency" is such a buzzword in the health and government communities. The FDA wishes to be more transparent. They've set up the FDA Transparency Blog. Pharmaceutical companies are doing things to become more transparent. Academic medical institutions are providing more faculty disclosures to be more transparent about industry relationships. The White House is becoming more transparent through its Open Government Blog. Will all these initiatives directed towards transparency revive the blogging industry?

Have you checked out these transparency-related blogs? Let me list them again:

• FDA Transparency Blog: http://fdatransparencyblog.fda.gov
• Open Government Blog: http://www.whitehouse.gov/open/blog

Will we reach a point where we feel like all this transparency may actually be harmful? What if people can't handle all the truth? Maybe some people would rather live in ignorance. After all, ignorance is bliss, right?

Physician social networking online

Most of my physician colleagues agree that most physicians generally don't engage in online social networking. The only exceptions would be those who use Sermo, and a small handful of early adopters. So who are those early adopters? Who are those who see value in online social networking?

• Are they the physicians who have a strong interest in medical informatics (or health information technology)? Sometimes.
• Are they the physicians who are actively looking for new job opportunities? Rarely.
• Are they the physicians who tend to be more adventurous and active (such as emergency room physicians)? Sometimes.
• Are they the physicians who have way too much free time (such as dermatology and radiology physicians)? Sometimes.
• Are they those MD/MBA grads who are always trying to find new ventures. Sometimes.
  

So, who are those early adopters? Most of the time, they are the medical students who already use social networking tools like blogs, Facebook, and Twitter. They are the ones who graduate and become those physicians who embrace the power of social networking.

Healthcare reform and jobs

How will healthcare reform initiatives impact the job market in the United States? I think many people are anticipating a boom in the health information technology (health IT) sector. That's to be expected, considering how the American Recovery and Reinvestment Act of 2009 (ARRA) focuses tremendously on the role of health IT (or HITECH) in healthcare reform. Will healthcare reform boost employment? Improved health should raise productivity. What about the "pay-or-play" mandate on employers? They must either offer benefits or pay a fine.

There are some other perspectives to consider when we think about healthcare reform. Catherine Arnst writes in BusinessWeek about how healthcare reform may spur employment. She cites MIT economist Jonathan Gruber (an MIT alum who also studied at Harvard, but we won't hold that against him) for the Small Business Majority. Professor Gruber estimtaes that if reform doesn't occur and small businesses are spending over $2 trillion on healthcare over the next decade, then this may lead to a loss of 178,000 jobs in 2018.

Medicine and Technology: Most popular posts last week

Here are the most popular posts from last week:

1. What happens if you eat magnets?

2. Alternative Cancer Care in Mexico

3. Is it better to eat ice cream after lunch or dinner?

4. Epic MyChart

5. New Analgesic: Nucynta (tapentadol)

6. Michael Jackson's death

7. Jobs for Physicians with No Residency Experience

8. How many nursing homes use Electronic Health Records (EHRs)?

9. Jackson's health and mental problems

10. Q&A on Healthcare Reform