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Tag: prevention

Ten Health and Wellness Resolutions Not to Make in 2014

We don’t make a lot of New Year’s predictions, but we are happy to make this one: 2014 will be the year the get-well-quick mentality driving corporate and individual health choices implodes…and people start taking genuine steps to be healthy. The way to ensure that 2014 is your year for good health?  Start with a double negative:  (a) wellness industry advice is almost always wrong; and (b) most people don’t keep their New Year’s resolutions. Hence, making the New Year’s resolutions recommended by the wellness industry is not the best way of ensuring your good health in 2014.

For simplicity, we’ll divide this list into individual and corporate wellness industry resolutions, and start with individual ones.

  1. Take more health advice from celebrities. Whether it’s hoping that Kim Kardashian’s personal trainer can help you or pining for Dr. Oz to cure what ails you with green coffee bean extract and raspberry ketones, a good way to put off doing worthwhile things is to do worthless ones.

  2. Start a weight loss program. The medical establishment could not head off the obesity dilemma at the pass, and they have no solution for it now, other than to crow about more drug companies diving into this expanding market. There is zero evidence that weight loss programs can produce sustainable long-term weight loss (and much evidence that they don’t), and we don’t know of a single one shown to improve fitness. That will not, however, prevent weight loss companies from trying to claim their little piece of the wellness landscape because they are losing so many individual customers to free dieting apps, such as LoseIt.com. Improve the quality of your diet first, and weight loss may follow, which is a bonus.

  3. Give yourself a cleanse. America’s obsession with cleanliness is now running smack into the reality of evolution and human physiology.  Surely if bacteria in your colon were bad for you, mankind would have died out eons ago.

  4. Stock up on supplements. The only things better than raspberry ketones and green coffee bean extract: all the other vitamin and mineral supplements on the market that fail to make sick people better or healthy people healthier. Who’s left to try to help, Martians? Never mind that risk is not endlessly reducible and the four most important things you can do for your health don’t come out of a bottle of magic jujubes: exercise, don’t smoke, eat well, and keep as close to a healthy weight as you can.

  5. Remove saturated fat from your diet. Just like in the 1960s, when we all traded in “the high-priced spread” for sticks of partially hydrogenated vegetable oils fit for a king to avoid saturated fat, we may be mis-demonizing this longstanding and naturally occurring component of our diet.   The entire nutrition dialectic in our culture over the past 20 years has focused on a string of individual no-nos: fat, saturated fat, cholesterol, and now refined grains and sugars (because we bought the government’s wrong advice to eat low-fat). It’s time to revive the notion of healthy eating patterns, not healthy eating isolates. In fact, here is the world’s simplest diet advice for 2014: eat less junk. That alone would be a landmark nutritional achievement for Americans.

  6. Eat organic and stay away from Starbucks. Within a week of each other, the New York Times published an account of a woman damaging her health eating an obsessively healthy and organic diet, and USA Today wrote of  another who ate exclusively at Starbucks for a year, with no apparent ill effects and no weight gain.

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Healthism: The New Puritanism

Here is a thought experiment. Assume that every hour you run you extend your life by an hour.

I have chosen a one-to-one ratio between the increase in longevity from running and the time running because higher ratios lead to the immortality paradox. Lazarus aside, the all-cause mortality for Homo sapiens is 100 % and will remain so for the foreseeable future.

This arithmetic means that at one point you will literally be running for your life: your life being extended precisely by the time spent running. But ignore this logical fallacy.

You run an hour every day for 40 years. Your life is extended by 1.67 years. Your costs are a new pair of running shoes every three months, which might even be covered at zero co-payment by insurance if USPSTF gave running a grade A or B recommendation.

A back of the envelope calculation, assuming the shoes cost $ 80, yields cost per life year of roughly $7664. There is, of course, more nuance. I am not including injuries that may result from running. I am not discounting time: I am assuming we value an hour now the same as an hour 40 years from now.

I am also not factoring the costs avoided of treating late stage cardiovascular disease, which must be balanced against the additional social security checks that the individual will draw because of living longer, not to mention the costs of treating diseases of extended longevity such as cognitive impairment, Alzheimer’s disease, recurrent falls.

But please continue to indulge my approximation. The point is not precision of economic calculations but a principle.

$7664 for an additional life year. Compared to the benchmark of $50, 000 per quality-adjusted life year that’s a bargain!

Was it worth it then?

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The FDA Ban on Trans Fat Should Be Just the Beginning

It’s been clear for more than a decade that trans fat is a dangerous substance that increases the risk of heart disease.  Denmark banned its use in 2003.  Several American cities and states have followed suit, but the use of trans fat is still widespread despite the availability of suitable substitutes.

Over the past 10 years, trans fat consumption is thought to have contributed to an estimated 70,000 needless American deaths. Given  that universal, voluntary cooperation to eliminate trans fat hasn’t happened, the Food and Drug Administration (FDA) is justifiably seeking to designate trans fats as unsafe.

A nationwide ban on artery-clogging artificial trans fat is a long-overdue first step toward improving American diets, fighting obesity and limiting the risk of chronic disease. But it is just the first step in what should be a far broader campaign to help consumers make healthier choices at mealtime.

Public lack of awareness of the impact of prepared foods on individual health is not limited to trans fat.   When dining out, even in establishments that avoid trans fats in preparing food, Americans face a range of health risks often without realizing it. People are routinely served far more calories than they can burn.

They are routinely served too many low nutrient foods and insufficient quantities of fruits, vegetables, and whole grains.  What should become routine instead is the availability of menu options that put people’s health first.

Hopefully, the FDA’s trans fat initiative will succeed – previous city/state bans and labeling improvements have already managed to cut daily consumption by Americans from 4.6 grams in 2006 to 1 gram in 2012 – and pave the way for the creation of other standards and regulations regarding the quantity and quality of food that is offered to diners in restaurants.

The lack of such standards makes it difficult, if not impossible, for most people to recognize when they are being put at risk for a chronic disease.   If people are served too much of something (like calories), they would have to compensate by eating less later; conversely, if they are served too little of something (like vegetables), they would have to eat more later to neutralize the risk of chronic disease.

But most people lack the information they need to judge or track the quantity and quality of the nutrients they consume.

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Radiologist: Thou Shalt Disclaim by Law

There is an old joke. What’s a radiologist’s favorite plant? The hedge.

Radiologists are famous for equivocating, or hedging.

“Pneumonia can’t be excluded, clinically correlate”. Or “probably a nutrient canal but a fracture can’t be excluded with absolute certainty, correlate with point tenderness”.

Disclaiming is satisfying neither for the radiologist nor the referring physician. It confuses rather than clarifies. So one wonders why legislators have decided to codify this singularly unclinical practice in the Breast Density Law.

The law requires radiologists to inform women that they have dense breasts on mammograms. So far so good.

The law then mandates that radiologists tell women with dense breast that they may still harbor a cancer and that further tests may be necessary.

You may quibble whether this disclaimer is an invitation or commandment for more tests, or just shared decision-making, the healthcare equivalent of consumer choice.

But it’s hard to see why any woman would forego supplementary tests such as breast ultrasound, magnetic resonance imaging and 3 D mammogram, or all three, when their anxiety level is driven off the scale.

What piece of incontrovertible evidence inspired this law, you ask?

Perhaps a multi-center trial run over 10-15 years that randomized women with dense breasts to (a) mammograms plus additional screening and (b) screening mammograms alone, show that additional screening saves lives, not just find lots of small inconsequential cancers.

No. The law was instigated by a heart-rending anecdote, which avalanched into the “breast density awareness” movement, cloaked by an element of scientific plausibility: women with dense breasts may have a higher incidence of cancer; a conjecture of considerable controversy.

Wasn’t  the Affordable Care Act (ACA) supposed to usher an era of rational policy-making, guided by p values, statistics not anecdotes?

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Who Will Solve Healthcare For Our Parents And Grandparents? Probably Not Google.

I assume by now that you’ve heard the news: Google wants to tackle aging. Specifically, they announced this week the launch of Calico, “a new company that will focus on health and well-being, in particular the challenge of aging and associated diseases.”

Because, says Larry Page, with some “moonshot thinking around healthcare and biotechnology, I believe we can improve millions of lives.”

“Can Google Solve DEATH?” shrieks a TIME cover.

Google’s goal, it seems is to find ways to extend human lifespan and essentially stave off aging.

Coincidentally, on the same day Physician’s First Watch directed me towards this NEJM editorial, announcing that NEJM and the Harvard Business Review are teaming up on a project on Leading Health Care Innovation.

Here is the paragraph that particularly caught my eye:

“The health care community and the business community today share a fundamental interest in finding ways to achieve higher value in health care. The ultimate objective for both communities is to keep people healthy, prevent the chronic illnesses that consume a large fraction of our health care dollars, use medical interventions appropriately and only when needed, and create an economically sustainable approach to the delivery of health care. While we want to foster innovation and novel therapies against disease, we also recognize that, whenever possible, prevention of disease before it is established is the better solution.” [Emphasis mine.]

And therein lies the rub. Whether it’s Google or a high-powered partnership between NEJM & HBR, everyone is enamored of prevention and innovative cures.

Let’s prevent those pesky chronic diseases! Let’s cure aging!

Ah, spare me.

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Cleveland Clinic Trial of Breast Cancer Vaccine Moves Forward

A preventive breast cancer vaccine developed by Professor Vincent Tuohy of the Cleveland Clinic will be brought forward to the FDA for permission to begin clinical trials to see if it is safe and effective for use in women.

The vaccine was shown to be completely safe and 100% effective in preventing breast cancer in three animal models, (see study in Nature Medicine), and was also found to slow the growth of tumors that had already formed. The vaccine is especially powerful in inhibiting the growth of triple-negative breast cancer, the most aggressive form of the disease with the lowest survival rate.

Triple-negative breast cancer lacks estrogen, progesterone and Her2 receptors. It occurs in approximately 15% of cases is the kind of breast cancer most common in women who carry a BRCA mutation.

The initial clinical trials, called Phase I studies, will be conducted in two groups of volunteers, women with triple-negative breast cancer who have completed their treatment and are free of disease, and women who will be vaccinated shortly before undergoing bilateral prophylactic mastectomy (typically these are women like Angelina Jolie with BRCA mutations who elect to remove their breasts to lower their risk for cancer.)

The first group of women will be studied to determine the dose and effectiveness of the vaccine; the second will be studied to make sure the vaccine does not trigger an untoward immune response in breast tissue.

The vaccine targets an unique protein normally made only by women who are breastfeeding, alpha lactalbumin (ALA). In the 12 years Tuohy spent developing and researching his vaccine, he discovered that the majority of breast tumors express, or make, ALA. Priming the immune system with a vaccine so that it attacks any cell that makes ALA is the method by which Tuohy’s vaccine works.

Because the vaccine targets ALA, a protein necessary for successful lactation in healthy women, the vaccine would not be appropriate for use in women who are still in their childbearing years.

However, the majority of women diagnosed with breast cancer in the United States and other western countries are post-menopausal: at least 60% of the cases in the United States occur in women over 55; thus, Tuohy’s vaccine holds great potential as a preventive vaccine for the majority of women.

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Obesity and the AMA, Part Two

A likely unanticipated consequence of the AMA’s decision to label obesity a disease, even though their own scientific council said not to, is that this might serve as the macguffin leading to furtherance of a protected class of people.  This has serious implications not only for employment discrimination, but also for wellness programs, which often hinge vastly overblown claims of being able to help the obese who they almost universally label as “high risk” people.

Well, what if people who are obese, who are no doubt tired of being condescended to, first by wellness companies, and now by the AMA, decide that they are going to seek medical approval to opt out of wellness programs?  A study recently published in the journal Translational Behavioral Medicine reports on a highly coercive, electronically monitored walking program for obese people: 17% opted not to participate and another 5% actually got their physician’s approval to opt out.  The physician approval to opt out is key to any resistance strategy.

Under the final wellness rules issued by the federal government earlier this year, physician certification that it is medically unadvisable for an employee to participate in a wellness program creates a burden for the employer and wellness vendor.  They must provide reasonable alternatives that do not disadvantage the employee in terms of either time or cost and that address the physician’s concerns.

Further, if the employee’s physician disagrees with offered alternative, the employer and wellness vendor must provide a second alternative.  The coup de grace is that “adverse benefit determinations based on whether a participant or beneficiary is entitled to a reasonable alternative standard for a reward under a wellness program are considered to involve medical judgment and therefore are eligible for Federal external review.”

Targeting people based on body mass index (BMI) is an intellectually, morally, scientifically, and mathematically bankrupt approach.  The AMA’s decision will actually help obese people and advocates for their dignified treatment in the workplace and society start to understand that they can refuse to opt in to these insulting programs and, simultaneously, be protected from penalties.  Clearly, this is the opposite of what unsuspecting employers expect when vendors (and their own brokers) sell them these programs: more useless doctor visits, less leverage with penalties…and more employee disgruntlement.  Not just the obese will be disgruntled, but also those who have to pay the penalties because their BMI is too high to get the reward but not high enough to get a doctor’s note.

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Prostate Cancer: Not a Good Week

The general practice of oncology seems to come in waves of disease.  One week every breast cancer patient is in trouble, another sees multiple new cases of lymphoma or leukemia, the next it as if someone is giving away lung cancer (or perhaps cigarettes) and then three patients with pancreatic cancer end up in the ICU.  This week a portion of the 240,000 yearly USA cases of prostate cancer walked in our door. The rush of cases served as a reminder that when it comes to this illness, we have a long way to go.

First, Allen. He is 73 years old and has prostate cancer in one out of twelve biopsies. The cancer has a Gleason’s Score of 6 (a measure of aggressiveness of the cancer tissue: more then 7 is particularly bad), which means it is not fast growing.  We recommended that given the small amount of slow growing cancer, Allen should be watched without treatment (“Active Surveillance”).  What Allen found so difficult about this recommendation is that his son was diagnosed with prostate cancer just one month ago and his son, who is 49, has a Gleason’s 8 Prostate Cancer on both sides of the prostate, and is scheduled for robotic surgery.  More than having cancer, Allen is hurt by the feeling it should have been him.

Then there was Robert and Mike. Robert was in the office at 10:00am for evaluation of his newly diagnosed prostate cancer, PSA blood test 32 (high), Gleason’s 7, with evidence of invasion through the capsule of the prostate gland.  Fortunately, because prostate cancer likes to spread to bone, his bone scan is normal.  Despite Robert’s relatively young age (66), the surgeon recommends external beam radiation therapy (RT) instead of operating.  What is bizarre and makes my head spin, was that at1:00pm, in the same exam room, in the same chair, I saw Mike.  He has recurrence of prostate cancer, previously treated with surgery.  Now Mike needs RT.  Although Robert and Mike do not know that the other has cancer, they have worked together in the same small company for 28 years, and consider each other friends.
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The Biggest Urban Legend in Health Economics–and How It Drives Up Our Spending

The wellness emphasis in the Affordable Care Act is built around the Centers for Disease Control and Prevention’s (CDC) 2009 call to action about chronic disease:  The Power to Prevent, the Call to Control.   On the summary page we learn some shocking statistics:

  • “Chronic diseases cause 7 in 10 deaths each year in the United States.”

  • “About 133 million Americans—nearly 1 in 2 adults—live with at least one chronic illness.”

  • “More than 75% of health care costs are due to chronic conditions.”

Shocking, that is, in how misleading or even false they are.  Take the statement that “chronic diseases cause 7 in 10 deaths,” for example.  We have to die of something.   Would it be better to die of accidents?  Suicides and homicides?  Mercury poisoning?   Infectious diseases?    As compared to the alternatives, it is much easier to make the argument that the first statistic is a good thing rather than a bad thing.

The second statistic is a head-scratcher.  Only 223 million Americans were old enough to drink in 2009, meaning that 60% of adults, not “nearly 1 in 2 adults,” live with at least one chronic illness — if their language is to be taken literally.   Our suspicion is that their “133-million Americans” figure includes children, and the CDC meant to say “133-millon Americans, including nearly 1 in 2 adults, live with at least one chronic illness.”   Sloppy wording is not uncommon at the CDC, as elsewhere they say almost 1 in 5 youth has a BMI  > the 95th percentile, which of course is mathematically impossible.

More importantly, the second statistic begs the question, how are they defining “chronic disease” so broadly that half of us have at least one?    Are they counting back pain?   Tooth decay?  Dandruff?   Ring around the collar?    “The facts,” as the CDC calls them, are only slightly less fatuous.   For instance, the CDC counts “stroke” as a chronic disease.   While likely preceded by chronic disease (such as hypertension or diabetes) and/or followed by a chronic ailment in its aftermath (such as hemiplegia or cardiac arrhythmias), a stroke itself is not a chronic disease no matter what the CDC says.  Indeed it is hard to imagine a more acute medical event.

They also count obesity, which was only designated as a chronic disease by the American Medical Association in June–and even then many people don’t accept that definition.   Cancer also receives this designation, even though most diagnosed cancers are anything but chronic – most diagnosed cancers either go into remission or cause death.    “Chronic disease” implies a need for and response to ongoing therapy and vigilance.  If cancer were a chronic disease, instead of sponsoring “races for the cure,” cancer advocacy groups would sponsor “races for the control and management.”  And you never hear anybody say, “I have lung cancer but my doctor says we’re staying on top of it.”

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Stop the Presses: A Disease Management Program Worked

I am known in the disease management and wellness fields as a naysayer, critic, curmudgeon, and/or traitor…and those are only the nouns that are allowed to be blogged across state lines.  This is because I am driven not by wishful thinking but rather by data.  The data usually goes the wrong way, and all I do is write down what happened.  Then the vendors blame me for being negative — sort of like blaming the thermometer because the room is too hot — because they can’t execute a program.

However, the nonprofit Iowa Chronic Care Consortium (ICCC) apparently can execute a program.  They reduced total diabetes events by 6% in the rural counties they targeted.  This success supports a hypothesis that in rural (presumably underserved) areas, disease management fulfills a critical clinical gap:  it provides enough basic support that otherwise would not be provided even to those who actively seek it to reduce near-term complications and exacerbations.

This result will likely produce its own unanticipated consequence: because many people now believe (thanks, ironically, to some of my own past work) that disease management doesn’t produce savings, there will be widespread skepticism about the validity of this study.  Quite the opposite:  this “natural experiment” is as close to pristine as one could hope for in population health, for five reasons:

  1. There was no participation/self-selection bias because outcomes were measured on all Iowa Medicaid members.
  2. The program was offered in some Iowa counties but not others, so there was no eligibility or benefits design bias, Medicaid being a statewide program.
  3. The program encompassed only one chronic condition (diabetes) rather than all five common chronic conditions normally managed together (asthma, CAD, CHF, and COPD being the other four).   Since all five conditions were tracked concurrently, whatever confounders affected the event rate in one of those conditions should have affected all of them.   And event rates in the four other conditions did indeed move together in both the control and study counties.   Just not diabetes.
  4. The data was collected exactly the same manner by the same (unaffiliated) analysts using exactly the same database so there is no inter-rater reliability issue.
  5. Both groups contained hundreds of thousands of person-years and thousands of events.

As one who has reviewed another high-profile “natural experiment,” North Carolina Medicaid, and found that the financial outcomes were the reverse of what the state’s consultants originally claimed (incorrectly, as they later acknowledged by changing their answer), I can also say that natural experiments in population health don’t harbor some as-yet-unidentified confounder that causes the study population to outperform the control population.

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