This summer a Salmonella outbreak traced to contaminated eggs has sickened over 1,000 people and led to the recall of over 500 million eggs.

Eggs are particularly susceptible to Salmonella contamination.  The outsides of egg shells can be contaminated by bacteria if they come into contact with chicken droppings or with dirt.  That’s why you should discard cracked or dirty eggs.  The shell itself is fairly resistant to bacteria, but if the chicken is infected with Salmonella then the eggs it produces will contain Salmonella also, inside the shell.

The risk of getting sick is decreased substantially by safe food procedures that kill Salmonella or inhibit its growth.  Eggs should be kept refrigerated at all times.  Eggs should be cooked thoroughly so that the whites and yolk are solid.  And eggs should be eaten promptly after they are cooked.

Check out the tips from the Centers of Disease Control (link below) for more simple suggestions to avoid a Salmonella side dish.

Learn more:

The Centers for Disease Control and Prevention:  Tips to Reduce your Risk of Salmonella from Eggs

Wall Street Journal article:  Eggs’ ‘Grade A’ Stamp Isn’t What It Seems

Tangential miscellany:

I wish everyone a happy and safe Labor Day, and I wish my Jewish readers a healthy, sweet and prosperous year.  There won’t be a post next week, but your appetite for health-related news will again be sated the week after that.

I’ve written before about how the error rate in the practice of medicine is far greater than that in other industries.  I’m not talking about when doctors make a difficult decision that in retrospect was wrong; I’m talking about just plain mistakes, such as when one medication is ordered but another is dispensed or when the dose dispensed is 10 times greater than what was what was intended because of an extra zero was written in the order.  We are finally looking to fields such as aviation to learn how to adopt safe practices in every part of patient care.

And though our error rate is too high, even with best practices it will never be zero.  Even in aviation some planes go through the regular maintenance, go through the take-off checklist, and still crash.  In a diner, an error might lead to a ruined meal.  In healthcare, and error can lead to a catastrophic injury.  So what should doctors do after an error has already happened?

The standard paradigm for handling medical error management has been the legal defense.  Doctors were advised not to communicate with the patient or the family for fear that they would disclose something that would increase their legal liability.  Patients and family members felt cut off from information just when they felt most injured and vulnerable.  Doctors felt unable to continue caring for the patient and to express remorse for what happened.  Rather than concentrate on helping the family and the patient recover from the mistake, the focus was on preparing for the anticipated lawsuit.

Fortunately, the paradigm is shifting.  More and more institutions are moving to a policy of complete and prompt error disclosure.  Physicians are trained to sit with patients and families immediately after adverse events, explain what happened, tell them what is known so far, and explain that the institution will promptly investigate the details of the case to see if errors occurred.  Importantly, physicians can express remorse.  If errors are discovered by the internal investigation, the patient or family are informed of the error and offered compensation.

This open approach has met with some resistance due to the fear that it would lead to more frequent malpractice suits and awards.  A study in the current issue of Annals of Internal Medicine suggests that the opposite may be the case.  The study reviews malpractice claims against the University of Michigan Health System (UMHS) from 1995 to 2007.  In 2001 UMHS implemented a program of full disclosure of medical errors with offers of compensation.  The study shows that the rate of lawsuits, patient compensation and legal costs all declined after the change.

So transparency and honesty after errors is not just the most ethical policy.  It’s the better business policy too.  The hardest time to be honest is after something goes horribly wrong, but that’s when patients most count on our honesty.  Many patients and families are ready to forgive if they see that we are doing everything possible to assure the error doesn’t happen again.  We now no longer have a legal excuse for not knowing how to say we’re sorry.

Learn more:

New York Times article:  When Doctors Admit Their Mistakes

Annals of Internal Medicine article:  Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program

My post in 2007 about teaching physicians to disclose errors:  Learning to Say “I’m Sorry”

My post in 2009 about adopting a culture of safety in healthcare:  Got Safety?

Summertime, and the livin’ is uneasy
Stocks are slumpin’
Unemployment is high

(with apologies to George Gershwin)

Reminders of the end of summer are upon us.  Kids are returning to school.  Rain covers are thrown over backyard grills.  Flu vaccines are arriving in doctor offices.

This season’s influenza vaccine is here.  It contains the flu strains most likely to reach North America this fall including H1N1, the flu strain formerly known as swine flu which caused so much hoopla last year.

The Centers of Disease Control this year decided that that the flu shot should be recommended for everyone over 6 months of age so as to limit the spread of flu and protect more people.  The vaccine is particularly important for the following groups:

• Pregnant women
• Children younger than 5, but especially children younger than 2 years old
• People 50 years of age and older
• People of any age with certain chronic medical conditions
• People who live in nursing homes and other long-term care facilities
• People who live with or care for those at high risk for complications from flu, including:
  • Health care workers
  • Household contacts of persons at high risk for complications from the flu
  • Household contacts and out of home caregivers of children less than 6 months of age (these children are too young to be vaccinated)

The following people should not be vaccinated:

• People who have a severe allergy to chicken eggs.
• People who have had a severe reaction to an influenza vaccination.
• People who developed Guillain-Barré syndrome (GBS) within 6 weeks of getting an influenza vaccine.
• Children less than 6 months of age (influenza vaccine is not approved for this age group), and
• People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)

So get your flu shot now, and start dreaming of an influenza-free winter.

Learn more:

The Centers for Disease Control and Prevention:  Key Facts About Seasonal Flu Vaccine

This week I discovered how painful it can be to change a habit.  Not because it means admitting I was doing the wrong thing, but because it means analyzing how feeble my reasons were for the habit in the first place.

Ever since I started practice I’ve been recommending calcium supplements to post-menopausal women.  Why?  Mostly out of habit.  There’s not a shred of evidence that calcium supplements prevent fractures, but some suggestion that they may help bone density.  But what’s the harm?  Calcium supplements are safe and wholesome and natural, right?

Last week the journal BMJ published a meta-analysis of randomized trials which compared calcium supplement against placebo.  (Expand your geeky medical literature vocabulary!  A meta-analysis is a study that systematically reviews already published studies on a particular topic and statistically pools together the results of all these studies.  The goal of a meta-analysis is to reach a more definitive conclusion than the individual studies did.)  It’s important to note that these trials were not studying the effects of calcium supplement on heart attacks.  They were each looking at the effect of calcium on different outcomes – bone density, fractures, colon cancer, whatever.  The investigators looked through the original study data and (where the data was available) counted the numbers of heart attacks in patients taking calcium supplements and in those taking placebo.

For the studies in which data was available on individual patients, about 3.5% had heart attacks on calcium while about 2.7% had a heart attack on placebo over an average follow up of 3.6 years.  That may not seem like a big difference but it means that for every 69 patients on calcium rather than placebo for 5 years there was one extra heart attack.  Some media reports characterized this as a small increased risk of heart attacks, but it’s not.  It’s in the same numerical ballpark as the decrease in heart attacks from treating high blood pressure.

Even if this harm was numerically small, remember, we have to weigh it against a completely unproven benefit.  Doctors have been recommending calcium supplements on the assumption that they prevent fractures, an assumption that has not been demonstrated in trials.  The study calculates that, even taking optimistic estimates for fracture reduction from calcium supplements, treating 1,000 people with calcium supplements for five years would cause an additional 14 heart attacks and prevent 26 fractures.  That’s a terrible tradeoff.

So calcium supplements seem to be a bad idea.  But there are some important additional points.  First, the authors were careful to state that dietary calcium (calcium in your food, not in supplements) has never been implicated in heart attack risk and is presumably safe.  So we should be getting our calcium in our diets, not in supplements.  Second, this study did not address vitamin D, which has many proven benefits that calcium does not.  So keep taking your vitamin D supplements.  Finally, patients with osteoporosis who are taking medications that rebuild bone need excellent calcium intake for the medication to be effective.  In these patients, who are at high risk for fracture, the benefit of calcium supplements may be greater than the risk.

An editorial in the same issue of BMJ concluded that “given the uncertain benefits of calcium supplements, any level of risk is unwarranted,” and that calcium supplements “should not be given without concomitant treatment for osteoporosis.”

So as painful as it is to change my mind about something I thought was completely benign two weeks ago, for my patients who do not have osteoporosis, I recommend stopping calcium supplements.  Obviously, if you have questions about your unique situation, ask your doctor.

Maybe next week I’ll find out that smelling roses causes seizures.

Learn more:

BMJ article:  Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis

BMJ editorial:  Calcium supplements in people with osteoporosis

LA Times Booster Shots:  Calcium supplements increase the risk of heart disease in the elderly, study says

Doctors are expected not just to diagnose and treat diseases but to prevent disease by counseling patients about behaviors that expose them to risk.  We are expected to ask patients about smoking, alcohol use, high-risk sexual behavior, failure to use seatbelts and dancing on windowsills.  We are expected to counsel our patients to refrain from behaviors that may lead to injury or disease.

“Mrs. Jones, I’m very worried about the fact that you grease your stairs with motor oil.  I advise that you stop.”

To the list of dangerous behaviors we should be asking our patients about, we now must add distracted driving.  A perspective article in this week’s New England Journal of Medicine argues eloquently that distracted driving due to cell phone use is a major cause of preventable injury and death, and that physicians have a duty to warn and educate patients about it.

It’s important to note that this is a perspective article, similar to an op-ed piece, and not a scientific paper.  The science here is quite thin, but no ethical randomized trial can be imagined in which drivers are assigned to an attentive or a distracted group and then broken bones are tallied.  The few observational studies available suggest that distracted driving impairs drivers about as much as alcohol intoxication.

Though texting while driving is obviously dangerous, the author argues that even talking on the phone hands-free is distracting and keeps drivers from focusing all their attention on the task at hand.  She argues that talking on a cell phone is much more impairing than listening to the radio or talking with a passenger.

The data, though, is fuzzier.  A study from Virginia Tech (see link below) used video cameras in actual cars and trucks and observed drivers over more than 6 million miles.  They correlated driver behavior with the risk of a crash or a near crash.  They conclude that

Driving is a visual task and non-driving activities that draw the driver’s eyes away from the roadway, such as texting and dialing, should always be avoided.  “Headset” cell phone use is not substantially safer than “hand-held” use, because the primary risk associated with both tasks is answering, dialing, and other tasks that require your eyes to be off the road.  In contrast, “true hands-free” phone use, such as voice activated systems, are less risky if they are designed well enough so the driver does not have to take their eyes off the road often or for long periods.

So just don’t text while driving, and don’t read that text that you just received.  And if you have to dial to make a call, consider waiting until you arrive at your destination.  And remind me to ask you about this at your next annual exam.

Fortunately, I ride my bike to work.  But maybe I should find a different time to do Sudoku.

Learn more:

Reuters article:  Doctors urged to warn against cellphone use in cars

US Department of Transportation official website for distracted driving:  www.distraction.gov

New England Journal of Medicine perspective article:  The Most Primary of Care — Talking about Driving and Distraction

Virginia Tech Transportation Institute article:  New Data from VTTI Provides Insight into Cell Phone Use and driving Distraction

Tangential miscellany:

In the interests of full disclosure, this is a shameless plug for my esteemed colleague, friend and neighbor, Dr. Jonathan Corren, who is also a terrific allergist.  His new book 100 Questions & Answers about Allergies was just published and offers a comprehensive guide to allergy diagnosis and management written for patients.  I haven’t read it yet, but when I do, I’ll review it here.

Finally, medical news posting will be on hiatus for two weeks and will resume July 2.

Three months ago I wrote about carotid artery narrowing, which is one of a number of causes of stroke.  There are currently two alternative treatments for severe carotid artery narrowing:  surgery, called endarterectomy, to open the artery, and a newer procedure called carotid artery stenting.  (Read my previous post, link below, for some background about these procedures and their role in stroke prevention.)

Thus far, carotid artery stenting has not been shown to be as safe as endarterectomy.  So endarterectomy has remained the proven standard.

This week stenting finally gains some credibility in the largest study to compare the two treatments, published in this week’s New England Journal of Medicine.  Over 2,500 patients with carotid artery narrowing were randomized to stenting or endarterectomy.  They were followed for serious complications immediately after the procedure or for strokes in the subsequent years.

Surprisingly, the patients receiving stenting did overall as well as the patients undergoing endarterectomy, making this the first study in which endarterectomy was not clearly superior.  Stenting carried a slightly higher risk of stroke after the procedure, but endarterectomy had a higher risk of heart attack.  Interestingly, patients younger than 70 tended to do better with surgery, while older patients did better with stenting.

So stenting is finally finding some role in treating carotid artery narrowing.  Training and experience in the physician performing either procedure is vital.

An editorial in the same issue of the New England Journal of Medicine concludes

… until more data are available, carotid endarterectomy remains the preferred treatment for most patients with symptomatic carotid stenosis; treatment for asymptomatic stenosis remains controversial. However, given the lack of significant difference in the rate of long-term outcomes, the individualization of treatment choices is appropriate.

Learn more:

New England Journal of Medicine article:  Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis

New England Journal of Medicine editorial:  Carotid-Artery Stenting in Stroke Prevention

LA Times Booster Shots:  Angioplasty plus stents is as good as surgery for clearing neck arteries, study finds

My previous post about carotid artery stenting:  Carotid Stenting Still Controversial

Varicella zoster virus (VZV) is the virus that causes chicken pox, usually a relatively minor childhood illness.  Unlike other viruses that are cleared from our bodies after infection, VZV stays in our sensory nerve cells forever.  Over the subsequent decades our immunity to VZV wanes.  When our immunity falls too low, VZV can reactivate and cause shingles.  Shingles is a painful blistering rash along the distribution of one sensory nerve.  The rash resolves in a few weeks, but in some older patients the effected patch of skin can remain painful for months or even permanently.  This painful condition after shingles is called postherpetic neuralgia and it can be quite debilitating.

In 2006 a vaccine to prevent shingles, Zostavax, became available.  It is recommended for everyone over 60 who has had chicken pox.  It has been proven effective in preventing shingles, and therefore in preventing postherpetic neuralgia.

But is Zostavax safe?  A large study in the current issue of Annals of Internal Medicine answered that question.  The study randomized over 38,000 patients to receive Zostavax or a placebo injection.  The side effects from Zostavax were not worse than from placebo.  Most of the side effects (like most vaccines) involved inflammation at the site of injection.

So to summarize, Zostavax is safe, and it effectively prevents a very painful potentially disabling condition. Recall also that all children are now being vaccinated against chicken pox, so that in 60 years Zostavax will not even be necessary since a generation will have grown up uninfected with VZV.

In anything resembling a rational healthcare delivery system champagne corks would fly, the makers of Zostavax would get a pat on the back (and well-deserved profits) and we would all shift our attention to more pressing matters.  Some patients would decide to buy Zostavax; some would not.  Private or government charity programs would pay for the vaccine for indigent patients.  Joy and health would reign.

But instead, there is gnashing of teeth and wringing of hands.  Why?  Because only about 7% of eligible patients have received the vaccine.  It turns out Zostavax is the most expensive vaccine recommended for adults (about $200) and the first to be covered by Medicare part D, the Medicare drug “benefit”.  That means pharmacists are paid to dispense it to patients, not doctors.

To sort out why more patients aren’t receiving Zostavax, another study in the same issue of Annals of Internal Medicine surveyed hundreds of primary care doctors about the barriers that might be preventing them from recommending and administering Zostavax to their patients.  The results: the biggest barrier was financial.  Many patients without coverage don’t want to pay for it, and doctors aren’t being paid by insurance companies to administer it.

This was such a staggeringly shocking finding, that it merited an editorial in the very same issue of Annals.  That’s three articles about a vaccine that works as intended and is safe.  The editorial opines that reimbursement should be revised to promote increased utilization of the vaccine.  In other words, we should take more money from other people to assure that patients who don’t want to pay for their own Zostavax can get it for free.

Now don’t get me wrong, I’m all for charity care for indigent patients.  (I volunteer at a clinic that serves indigent patients two afternoons a month.)  But the vast majority of patients who aren’t getting Zostavax aren’t poor; they just have better things to do with $200.

What the editorial didn’t say is that you can’t do much better than a product or service in which the main barrier to obtaining more is the price.  After all, that’s the only reason we don’t get twice as many clothes or cars or homes.  If the price was lower, we would.  If Zostavax was free, some other barrier to its use would necessarily arise, perhaps a lengthy wait, or a difficult to navigate bureaucracy, or rationing by some other means.

So perhaps each patient should shoulder the cost of his or her own Zostavax.  We should also all donate a little time or money for those who truly can’t afford it.  And some of us may rationally choose to accept the risk of shingles.  Alternatively, we could riot in Athens until the EU pays to keep us all shingles-free.

Learn more:

Annals of Internal Medicine Summary for Patients:  Safety of the Vaccine to Prevent Shingles

Annals of Internal Medicine article:  Safety of Herpes Zoster Vaccine in the Shingles Prevention Study

Annals of Internal Medicine article:  Barriers to the Use of Herpes Zoster Vaccine

Annals of Internal Medicine editorial:  The Looming Rash of Herpes Zoster and the Challenge of Adult Immunization

A friend of mine recently asked me “Is regular soda or diet soda better for you?”

I tried to probe for details.  “Are you talking about calories?  Obviously, if you’re watching your weight or restricting carbohydrates, you should have the diet soda.”

“No, I don’t mean the calories.”

“Oh, you mean the concern that the citric acid might leach calcium out of your body?”

“No.  I just mean overall, are they good or bad for you?”

This precipitated an important revelation that had been percolating in my head for years but that never actually crystallized until now.  People think of things we ingest as generally “good for you” or “bad for you”.  But nothing is globally good or bad.  Everything has specific effects, some positive and some negative.

Amoxicillin is great for Strep throat.  It’s not very useful for lupus or seizures.  Beta blockers are terrific to prevent heart attacks, but make for lousy asthma medicine.  Even water, which is essential for life, is life-threatening if inhaled.  The most universally positive health intervention I can think of is cardiovascular exercise, and even that has some risks, like muscle sprains.

With that in mind I found an interesting study in this week’s New England Journal of Medicine.  The study attempted to prevent a serious potential complication of pregnancy – eclampsia – which is dangerous to both the mother and the baby.  It was thought that antioxidants, like vitamins C and E, could prevent the chemical abnormalities that lead to eclampsia.  And besides, aren’t antioxidants good for you?

The study randomized about 10,000 pregnant women in their first pregnancy.  Half received a daily vitamin E and vitamin C supplement, and half received placebo.  The women and their babies were followed for any signs of eclampsia or pre-eclampsia.  The outcome was disappointing.  The women on the vitamin supplements did no better than the women on placebo.

So vitamin C and E don’t help prevent eclampsia.  Does that mean they’re “not good for you”?  No.  Vitamin C is essential in preventing or treating scurvy.  So if you have scurvy, I strongly recommend it.

Oh, and to answer my friend’s question about sodas, artificial sweeteners are safe as far as we know.  So I would prefer diet sodas to avoid the calories of non-diet sodas.  The only health benefit of sodas is that they contain water, which can be obtained from other sources.

Learn more:

New England Journal of Medicine article:  Vitamins C and E to Prevent Complications of Pregnancy-Associated Hypertension

My regular readers know the controversies and challenges posed by prostate cancer.  It is very common.  Over half the men who die at advanced age of other causes will have prostate cancer on autopsy.  It is very slow.  From the time that prostate cancer is detectable on biopsy to the time that it causes symptoms or shortens life can be as long as a decade.  It is not very lethal.  Because it tends to affect older men, most men diagnosed with it tend to die of other causes.  Though it does kill tens of thousands of men annually, it kills fewer (and older) people than colon cancer, lung cancer or breast cancer (or traffic accidents).

This confluence of a very common but very indolent disease that strikes mostly older men has made screening, diagnosis and treatment very challenging.  Should we be testing for a disease that lots of people will get but that most people won’t be harmed by?  No one knows yet.

These challenges have prompted some researchers to consider prevention.  What if instead of testing, diagnosing and treating we could give men at high risk of prostate cancer a medicine that made prostate cancer less likely?  To be more cynical, the finances are also tempting since many more “at risk” men would have to take a preventive medicine than would actually get prostate cancer.

A large study published in this week’s New England Journal of Medicine shows that dutasteride, sold under the brand name Avodart, can decrease the incidence of prostate cancer in some men.  This has received much media attention.  (See links below.)  But let’s review the details before prescribing it to your uncle and grandpa.

The study enrolled over 8,000 men who were thought to be at high risk for prostate cancer because of their age or an elevated PSA.  (PSA is a not-very-accurate blood test used to test for prostate cancer.)  They all had a prostate biopsy at the beginning of the study and only those with negative biopsies (i.e. no detectable cancer) were enrolled.  Half the men were randomized to take Avodart daily, and half to placebo.  All the men had prostate biopsies two years and four years after enrollment.  The study sought to find if there was a difference in the numbers of prostate cancers found in the biopsies of the two groups.

Sure enough, Avodart seemed to decrease the incidence of prostate cancer found in the biopsies.  20% of the men taking Avodart were found to have prostate cancer versus 25% of the men taking placebo.  But so what?  Not a single person in either group died of prostate cancer, and they wouldn’t have been expected to since the study lasted four years and prostate cancer takes much longer than that to cause harm.

There’s absolutely no way to know if the men taking Avodart will live longer or be spared the symptoms of prostate cancer without following them for a much longer time.  There is good reason to suspect that the men taking Avodart won’t do much better than the men taking placebo.  The number of very aggressive tumors (as measured by their Gleason score, a quantitative score related to the tumors’ microscopic appearance) was the same in each group.  It was only the least aggressive tumors that were decreased in the Avodart group.

Moreover, about 5% more men in the Avodart group than in the placebo group developed problems with libido or with erections.  So for every 20 men who take Avodart rather than placebo for 4 years, one fewer man develops prostate cancer on biopsy which may or may not ever harm him, but one additional man develops sexual side effects.  Add to that a small additional risk (about half a percent) of heart failure in the Avodart group, and the numbers are very discouraging.

An editorial in the same issue of the New England Journal of Medicine concludes that Avodart should not yet be prescribed for prostate cancer prevention.  We need to know much more about the outcomes of men who take it for decades, not years.

Learn more:

New England Journal of Medicine article:  Effect of Dutasteride on the Risk of Prostate Cancer

New England Journal of Medicine editorial:  Chemoprevention of Prostate Cancer

Los Angeles Times article:  Prostate drug may work as a preventive

Associated Press article:  Study finds possible heart risk with prostate drug

This week ABC World News aired a story about a possible side effect of osteoporosis medications.  The family of medications involved in this story is called bisphosphonates and includes Fosamax, Actonel and Boniva.  These medications have been proven to prevent fractures in patients with osteoporosis (very low bone density).  Apparently, some doctors had noticed the occurrence of an unusual kind of fracture, a break in the thigh bone between the hip and the knee, in some women who had been taking bisphosphonates for over five years.  Also unusual was that these fractures seemed to be happening with fairly small traumas, without the major impact expected to break a thigh bone.

So, faced with these reports, since television news is known for sober and uncontroversial reporting of well-researched information, ABC decided to hold this story until they checked out whether these fractures have anything to do with these medicines.

Ha!  Just kidding!  Of course ABC ran the story, frightening countless women into believing that they may be at risk for breaking a leg because they are taking a medication specifically to reduce such a risk.  (Actually given the declining broadcast news ratings, perhaps they only frightened the last dozen Americans without cable or internet access.)

Obviously, the important question is:  Are these rare fractures happening more frequently to women on bisphosphonates than to women with osteoporosis who are not taking bisphosphonates?  The most honest answer is:  nobody knows.  Nobody has yet done the counting.

I’m sure we could also find that men taking medication for baldness get sunburns on the tops of their heads more often then other men.  But that might be a consequence of the baldness, not of the medicine.  Similarly, women with osteoporosis are at higher risk of fractures than other women, and every study done so far shows that bisphosphonates reduce that risk.  Whether this unusual thigh fracture is an exception should be the subject of a careful study.  Until then, we just don’t know.

The FDA released a statement (link below) urging women not to stop their osteoporosis medicines without a discussion with their doctors, and reminding doctors that these new reports do not change the indications for using bisphosphonates.

The rest of us got a useful reminder not to get information from TV news.

(Thanks to my patient Joyce for pointing me to the ABC News story and to my friend and colleague Mark for pointing me to the FDA statement.)

Learn more:

FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures

Reuters article: FDA rules out bisphosphonate, thigh fracture link

ABC World News story:  Osteoporosis Drugs, Like Fosamax May Increase Risk of Broken Bones in Some Women