More Bad News for Zetia and Vytorin

Regular readers will remember that I wrote about Zetia back in November.  That post had some important background for this week’s news, and a handy lesson about the difference between clinical and intermediate outcomes in medical studies.  If you missed it, you may want to check it out.  This week, Merck released the data from a study comparing the growth of cholesterol plaques in the arteries of patients taking Zocor (a cholesterol lowering medication proven to prevent strokes and heart attacks) to those taking Zocor and Zetia.  The bottom line: Zetia didn’t help shrink the cholesterol plaques and may have actually accelerated their growth slightly.  Media hysteria ensued, including this article in the New York Times.  Thousands of patients have been calling their doctors, confused about what to do.

The American College of Cardiology tried to calm the situation by releasing a statement reminding patients that “this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional.”  The statement also included a position about the appropriate role of Zetia and Vytorin, which has not changed with the release of this study.

“The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.”

Statins have always been first line for cholesterol treatment because of their proven reduction of strokes and heart attacks.  Zetia has never been proven to prevent strokes and heart attacks, and should only be used if more statin can’t be tolerated.  Nothing about that changed this week.

(I’m grateful to Dr. Mark Urman and Dr. Yaron Elad who each pointed me to the American College of Cardiology statement.)

Tangential Miscellany:

There will not be a medical news post next week.  The weekly post resumes the week of January 28.

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The More Things Change

Change is always painful, even when everyone benefits from it.  We usually do our best to ignore slow trends, keeping our comfortable habits and pretending that the world will never surprise us.  I’m sure long after Ford started selling cars there were plenty of horse buggy makers who were sure that the car would always be an expensive frill for the very few.

I don’t think anything in the last 15 years has revolutionized our lives as much as the internet.  It has transformed how we shop, communicate with each other, gather news, get entertainment, and even form communities.  It has radically democratized journalism, entertainment and advertising.  Now anyone at a disaster can report what she has seen on her blog.  Anyone can shop for obscure items from sellers all over the world.  Anyone can share his art with a nearly unlimited number of fans.  Like all technological progress, this brings even more power to individuals, and away from large powerful groups.  But like all change, this too is painful.  (Just ask a screenwriter.)

The internet has narrowed the difference between the expert and the novice.  Experts no longer have a monopoly on information.  Patients can access as much information as doctors, and frequently notice new studies before their physicians do.  Some doctors are annoyed by this.  Defensive about their eroding knowledge gap, and (like everyone) fearful of change, some doctors cling to the role of expert and refuse their new role of teacher.  They can’t stand patients who bring in 5 studies from the internet and challenge their recommendation, or email them about an article that just came out today, or send them links to websites that advocate sheer quackery.

I love that.  Any professional who thinks their value is in finding information that no one else has is in for a rude awakening.  Google can do that cheaper and faster.  I have no information that my patients can’t find without my help.  The value doctors deliver is in exercising their judgment, and in teaching.  “This herbal product has never been tested and the website that praises it is the same one trying to sell it to you.” “This family of medications has been proven to prevent kidney failure.  Here’s a link to the study.”

Yesterday, Salon published a great article that argues convincingly that the internet has been a boon for both patients and doctors.  More doctors should read it; otherwise, we’re just perfecting our horse buggies.

(I’m grateful to Luetrell T. for pointing me to the Salon article.)

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Treatment for Localized Prostate Cancer: Many Options, Little Evidence

I’ve written before about the controversies in screening for and treating prostate cancer.

Prostate cancer presents a unique challenge because it is extremely common, affects men who on average are older than patients with other cancers, and usually takes many years between diagnosis and disability or death.  In 2007, approximately 1 in 6 men in the United States were diagnosed with prostate cancer, and 1 in 34 died of it.  The median age at diagnosis was 68 years, older than that for any other cancer.  Because prostate cancer strikes men whose life expectancy is usually limited by age or by other diseases, it has been difficult to prove that screening for prostate cancer saves lives, or that any treatment for it is better in terms of survival than any other.

Last week’s New England Journal of Medicine had a very useful review of treatment options for localized prostate cancer (that is cancer that has not spread beyond the capsule of the prostate).  Treatment decisions are based on the following factors: the patient’s age, life-expectancy, Gleason score (microscopic appearance of the cancer), the PSA (prostate-specific antigen, a blood test used to screen for prostate cancer), and the clinical stage (roughly related to the estimated volume of the tumor).

Expectant management
Expectant management, also called active surveillance, involves frequent re-evaluation of the PSA, the digital rectal exam, and prostate biopsies with the hope of detecting progression of the cancer when it is still curable.  This strategy is thought to be appropriate either for men who have a life expectancy of less than 10 years, or for healthy men 65 or older with low-volume low-grade prostate cancer.  Some small studies suggest that this strategy is no worse for survival than the other two, and it is much less invasive.

Radiation therapy
Radiation therapy offers the promise of a potential cure of the cancer with treatment that is somewhat less invasive than surgery.  New technological improvements have made it possible to better spare normal surrounding tissues while targeting the radiation to the prostate.  Nevertheless 40 to 60% of patients suffer impotence and 18% have rectal bleeding requiring transfusion or invasive intervention.  (Expectant management sounds better now.  Right?)

Surgery
Surgery is thought by some to be the most likely to be curative (again, without much evidence).  The complications, however, include urinary incontinence (3% of patients) and impotence (30% of patients in the hands of the most experienced surgeons).

What is truly startling, however, is that there are no studies to help patients definitively choose the right treatment option.  Treatment options of millions of men are made largely with well-intentioned hunches.  Three large randomized trials are in progress to answer if screening and treatment for prostate cancer saves any lives.  We may have some answers when two of the trials reach completion five years from now.

In the meantime, patients who opt for radiation should use centers with extensive experience and with beam shaping technology that minimizes injury to surrounding tissues.  Similarly, patients choosing surgery should be referred to surgeons with extensive experience in radical prostatectomy.

And, in my opinion, patients should receive guidance from an oncologist experienced in prostate cancer treatment, an experienced urologist, and a radiation oncologist, before making any decision.

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Medical Myths Even Doctors Believe

“It ain’t what you don’t know that hurts you; it’s what you know that ain’t so.”
— Will Rogers

This week’s issue of the British Medical Journal has a fun article analyzing seven popular medical myths that even some physicians believe.  The article was covered in the popular press including in this Yahoo News article and in this article in Newsweek.

The myths are:

  • People should drink at least eight glasses of water a day
  • We use only 10% of our brains
  • Hair and fingernails continue to grow after death
  • Shaving hair causes it to grow back faster, darker, or coarser
  • Reading in dim light ruins your eyesight
  • Eating turkey makes people especially drowsy
  • Mobile phones create considerable electromagnetic interference in hospitals.

Take a look at the articles if you’re interested in the details.

(Thanks to Timo K. and Linda T. for sending me links to the articles.)

Tangential Miscellany:

Have a happy and healthy 2008!

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May Your Days Be Merry and Bright

… not dark and SAD.
 
This week I have two quick important points about mood disorders.
 
First, this Saturday is the winter solstice which is the first day of winter and the day of the year with the shortest daylight.  (It’s also my wedding anniversary.  One of you please remind me on Friday!)  Every year in late fall or early winter some people develop increased appetite, sadness, excessive sleepiness and social withdrawal.  These are some of the symptoms of seasonal affective disorder (SAD).  Though SAD is much more common in more northern latitudes where daylight hours are even shorter, it does occur in sunny Los Angeles too.  The Mayo Clinic website has a very informative page on SAD.  Check it out if you know someone who doesn’t do well this time of year.
 
Second, last week I wrote about insomnia, and linked to an article that suggested that awakening in the middle of the night for an hour or two may be normal.  Barnet M. emailed me with a very important caution.  Insomnia might not be normal.  It might be a symptom of anxiety or depression.  If you are waking up ruminating about anxiety-provoking things, or if you’ve had changes in your mood or appetite or energy level, please don’t ignore your insomnia.  Discuss it with your doctor.  (Thanks, Barnet!)
 
Tangential Miscellany:
 
My wife, Janet, and I wish all my readers who are celebrating a merry Christmas.  May we all enjoy peace, laughter and health in 2008.

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Maybe We Shouldn’t Lose Sleep Over Insomnia

Insomnia is a very common problem, and sometimes a very frustrating and persistent one.  But what if our expectations of an uninterrupted 7 or 8 hours of sleep is unrealistic?  What if a night of sleep for 4 hours, wakefulness for an hour or two, and then more sleep for 3 hours is how most of humanity slept before artificial lighting?

In a provocative article last year in Applied Neurology, Dr. Walter Brown reviews historical descriptions of pre-industrial sleep and suggests that sleeping in two nightly shifts separated by an hour or two of quiet wakefulness is completely normal.  I encourage you to read it.  He proposes that the advent of inexpensive artificial light allowed us to stay awake long after sundown and has led us to be so chronically sleep deprived that we usually sleep for 7 uninterrupted hours nightly.  This uninterrupted sleep pattern has now become the new norm.  When our natural pattern of sleeping in two shifts reasserts itself, we find it abnormal and distressing.  We are sure something is wrong, and a whole industry has sprung up to reinforce our anxiety and help us sleep the way we think we should.

Our expectations about our bodies go a long way toward shaping what symptoms we find distressing and what we ignore.  Many patients are quite alarmed about entirely normal symptoms and refuse to be reassured.  But patients alone are not to be blamed.  Many forces have pushed modern medicine to pathologize normal symptoms.  After all, pharmaceutical companies sell prescriptions, not reassurance.  Doctors feel motivated to make diagnoses, not exclude them.

Physicians need to find a way to reassure patients when their symptoms are normal.  We need to learn to say “there’s nothing wrong” in a way that is not dismissive but credible and comforting.  And we need to become comfortable ourselves with the idea that sometimes there is no diagnosis.

(Thanks to Linda T. for pointing me to the article.)

Tangential Miscellany:

I began writing my weekly medical news posts almost two years ago.  This is my one-hundredth post.  The feedback and encouragement from all of you has been very rewarding.  I hope to continue to inform and teach as long as you all keep reading.  Thanks.

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Taking Blood Pressure Seriously

I’ve written many times about the U.S. Preventive Services Task Force (USPSTF), the most unbiased and authoritative group that reviews the literature on preventive healthcare.

Their latest recommendation is not surprising; it’s just a good reminder.  This week’s Annals of Internal Medicine has a USPSTF recommendation statement reaffirming their previous strong recommendation for periodic screening for high blood pressure for all adults.

The reasons are simple and well established by decades of studies.  High blood pressure doesn’t feel like anything; that’s why measuring it is necessary.  High blood pressure increases the risk of stroke, heart attack and kidney disease, which are major causes of death and disability.  High blood pressure is very treatable with safe medications that dramatically reduce those risks.

So if your loved-one hasn’t seen her doctor in a couple of years because she feels fine, or if your coworker is blowing off his high blood pressure because it’s only “a little high”, get them to see their doctor.

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Merck Knows More about Zetia than They’re Telling Us

(or How I Learned To Stop Worrying and Love the Pharmaceutical Industry)

I’d like to try to change the way you think about preventative medications.

The goal of prescribing blood pressure-lowering medications is not to lower blood pressure.  The goal of prescribing cholesterol-lowering medications is not to lower cholesterol.  The goal of prescribing medications for osteoporosis (low bone density) is not to raise bone density.  Let me explain.  The goal of medications that lower blood pressure and cholesterol is to prevent heart attacks and strokes.  The goal of medicines that treat osteoporosis is to prevent fractures.

The distinction may seem silly but is actually critical.  Strokes, heart attacks and fractures are what doctors and researches call clinical outcomes.  Clinical outcomes are things that directly affect patients, things that patients can notice for themselves.  Blood pressure, cholesterol and bone density, on the other hand, are intermediate (or non-clinical) outcomes, things that doctors can measure but that patients can’t feel directly.

The important lesson is that medicines that improve intermediate outcomes don’t always improve clinical outcomes.  There are medications that lower blood pressure without decreasing stroke or heart attack risk.  There are medications that lower cholesterol without decreasing stokes or heart attacks (like estrogen).  So the important question to ask is not “will this medicine improve my bone density?”  The important question is “will this medicine decrease my risk of fracture?”

Statins, a family of cholesterol-lowering medications which include Lipitor, Zocor, Crestor, and others, have been a boon for patients because of their proven benefit in preventing strokes and heart attacks.  Zetia, a cholesterol-lowering medicine that works differently than statins, has been proven to lower cholesterol but has never been studied to see if it improves clinical endpoints.

Last week’s NY Times had a disturbing article about Merck’s handling of data from a study about Zetia.  After completing a trial testing the effectiveness of Zetia, Merck has decided that they will only release data about some of the outcomes that were measured.  That’s definitely a reason for the rest of us to worry and for patients on Zetia to talk to their doctor.

Many of my colleagues and patients are very hostile to the pharmaceutical industry.  I’m not.  Without the pharmaceutical industry, after all, we’d never have statins.  I assume that, like all industries, they will try to sell us more than we need and will try to put the best spin on their products.  So the burden is on us, the consumers, to be educated and discriminating shoppers.

(Thanks to my colleague, Dr. Yaron Elad, for bringing the article to my attention.)

Tangential Miscellany:

A bright and happy Chanukah to all my Jewish readers!

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Shocking Study: Pedometers Motivate People to Walk More

Last week’s post generated many comments from you, and I appreciated them very much.

With Thanksgiving approaching and New Year’s resolutions around the corner many of us are reviewing our commitment to our exercise program (or realizing that for the last few months we’ve had no commitment and therefore no exercise program).  With this perfect timing, this issue of the Journal of the American Medical Association published a study looking at the benefit of using pedometers for increasing physical activity.  The study was also reported in this LA Times article.

The study was a review of the existing medical literature on pedometers, pooling together the data from 26 existing studies on the topic.  The review showed that pedometer users increased their physical activity, significantly decreased their body mass index, and decreased their blood pressure.  In addition to just using a pedometer, having a specific step goal, like 10,000 steps per day, was a strong predictor of increased activity.  That’s an important reminder about something that shouldn’t surprise us and is a useful trick in many aspects of life: making a specific goal is a critical step to achieving it.

So despite the fact that I’ve been giving out pedometers to my patients for about a year, I’m embarrassed to say that I stopped using mine (well, I actually lost it) months ago.  Time to break out a new one.

Let me know if you’d like a pedometer.  Now is always the right time for rededication to healthy goals.

Tangential Miscellany:

My wife and I wish you and yours a joyous Thanksgiving.  I hereby grant all of you a one day reprieve from the dietary limitations I scold you about during the rest of the year.  You may eat what you like provided that you are surrounded by loved ones and that happy expressions of affection and gratitude fill your home.

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Turning that Frown Upside-down

A patient of mine told me yesterday that she thought too many of my posts were negative:  this supplement doesn’t help, that medication doesn’t work, this intervention doesn’t make a difference.  She’s right.  A lot of my posts are negative.  There are two reasons for that.  One is that we’re constantly bombarded by advertisement and bogus information in the mass media about the latest and greatest medical wonder, usually long before any evidence exists about its effectiveness.  So I partially see my job as deflating those claims and reminding you that a lot of this stuff doesn’t do anything.  The other reason is that effective therapies are just so darned rare.  For every proven claim, there are so many others that are purely speculative, so I’d like to spread a little healthy skepticism to my readers.

But I guess everyone wants a positive story once in a while.

Of course the big picture is overwhelmingly positive.  Americans are living longer than ever, with an average life expectancy at birth of 77.8 years.  Treatments for high blood pressure, high cholesterol, diabetes, and heart disease are dramatically better than they were even ten years ago.  New surgical techniques make recovery from surgery easier.  (A very sweet 76 year-old lady who has been under my care for years was just admitted two days ago with acute appendicitis.  Her appendix was removed and she went home in wonderful condition this morning.)  New advances in understanding have revolutionized treatment for diseases like stomach ulcers.  (They’re caused by a bacterium!  Who knew?)  And the future promises further advances on all fronts.

So there’s great reason for optimism.

Next week, I’ll probably be back to something negative, like reminding you that your vitamin C supplement is worthless.

Tangential Miscellany:

Do you have a health-related topic you’d like me to write more about?  Less?  Let me know!

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