Sleeping with Big Pharma

     In the last blog, The Insomnia Epidemic, I spoke about how our natural sleep patterns differ from the "cultural norm" of one 6-8 hour block at night and suggested that this causes many folks sleep problems.
Sleep experts believe that our 24/7 culture has created such pervasive sleep deprivation that abnormal sleepiness is the norm. Unfortunately, there is no adapting to getting less sleep than we need. What happens is we adjust to a sleep-deprived state in which our judgement, memory, reaction time, and many other functions are impaired. Studies also document how our subjective assessment of performance with sleep deprivation is way off. We consistently think we're doing fine, until we really can't function. The experts say that if you feel drowsy during the day, even when bored, you haven't had enough sleep. Similarly, falling asleep within 5 minutes of lying down in bed suggests severe sleep deprivation. So there's no question, the public is hungry for more (or better) sleep. And a smorgasbord of medications are on offer everywhere you look, in magazines, on television, and on the internet.

     According to Medco Health Solutions, a prescription drug benefit program manager, the number of adults ages 20 - 44 using sleeping pills doubled from 2000 to 2004.  Children apparently have not been spared. Usage increased 85% in 10-19 year olds during the same period. And the trend has continued. In 2008 the sale of prescription sleep aids totaled $3 billion. The number of prescriptions written for sleep meds exceeded 59 million in 2009, an increase of approximately 4 million scrips from the previous year.  In 2010 the pharmaceutical industry took in $5 billion from the sale of sleep medications.

     How do we explain this astronomical rise in sleep medication usage? There are only a few possibilities.  It's hard to imagine that this population's sleep deteriorated so dramatically in these 4 years it accounts for this trend. Some might suggest that the sleep impaired were always out there but hadn't been diagnosed and treated until the recent focus on insomnia. While this may have some truth, it hardly explains the rate of increased usage of these meds. After all, insomnia is not a sexually transmitted disease. There is not a stigma attached to sleep disorders that would make it difficult for patients to report their concerns. Has the cultural environment changed significantly? Has this time period witnessed big changes in our use of mobil devices, lap tops, etc.? Did we become even more 24/7 since the turn of the century? Yes, to some extent we have.

    But I believe it's none of the above. So what happened?

     The combined effect of changes in three areas, medicine, advertising, and our psyche, created the perfect climate for these medications. Let's take them one at a time.

Medicine:
     Over the past two decades the practice of medicine has been transformed (some would say ruined). The average patient visit is 10 minutes. There is no time to discuss the patient's home life, work situation, social or financial stressors. There is no continuity of care. Patients bounce around to specialists without anyone overseeing the whole person. So if people complain of difficulty sleeping, there will not be an exploration of what's going on in their life. That takes way too much time.  Physicians continue to want to help. They want to respond to the patient's complaint.  In this context, the prescription is the best they've got.
     In addition, physicians diminishing control of the field of medicine (now run by government and insurers) and decreased remuneration has made them more susceptible to dubious practices such as responding to patient requests for specific medications.
     These forces have catalyzed the "medicalization" of sleep, a process where a formerly normal behavior is reframed as a medical problem. In fact, analysis of data over a 15 year period shows the new generation nonbenzodiazepine sleep med prescriptions grew 21 times more rapidly than did sleeplessness complaints and 5 times more rapidly than did insomnia diagnoses.  The inappropriate use of medical solutions to treat problems of living fits neatly into the changes in the American psyche that I discuss below.

Advertising:
     In the early 1980's the pharmaceutical industry began marketing prescription drugs directly to the public. The FDA questioned this practice and imposed a moratorium in 1983, but lifted it in 1985. Not surprisingly, there is a striking correlation between the amount of money spent on advertising for a drug and that drug's sales. The 4 million sleep scrip increase from 2008 to 2009 coincided with a direct-to-consumer 2008 ad budget of $500 million for Ambien CR and Lunesta, the most prescribed sleep meds that year.

Our Psyche:
     The funny thing about sleep medications is they don't change your sleep very much. If you look at efficacy studies you realize that people are not sleeping much better on these sleep medications that are selling like hot cakes. The studies show that on average, subjects fall asleep about 12 minutes faster and increase their total sleep time by about 15 minutes compared to placebo. And yet these very same subjects report that they slept well. So what gives?

     Well, it so happens that a side effect of these medications is something called anterograde amnesia, a state in which you cannot form new memories. In other words, you don't remember how you slept. (In fact you may not remember all sorts of things that went on during the night, like driving around, sending emails, or eating more than you thought humanly possible. But that's another story.) These agents also have an anti-anxiety effect. Not only might this help you fall asleep, but it also minimizes the impact of not doing so.    

     One Lunesta advert has a mellifluous women's voice cooing sympathetically "Does you restless mind keep you from sleeping?" That is a bullseye.  The American mind has reason to be restless. A decade ago, 9/11 presented the greatest shock in this country's history. What initially seemed to have the potential to unite the population and create common purpose quickly deteriorated. The country became polarized into red and blue, antagonistic camps speaking different tongues, accusing the other of being unpatriotic, unamerican.  For the past 10 years we have engaged in the "War on Terror", an amorphous conflict without boundaries, a means for assessing how we're doing, or consensus. We do not feel safer. 

Iraq and Afghanistan have not been transformed, but we have. Our belief in American ability and fair play has been compromised. Historically, national traumas have provided a fulcrum from which we have forced positive changes. None of the past decade's national nightmares, Hurricane Katrina, mortgage defaults, stock bubbles, a collapsing economy, or unemployment have been able to provide the stimulus for a gathering of transformative momentum.

     Why are sleep medications so popular? Because in the quiet darkness of our bedrooms with nothing to distract us, the mind struggles to empty itself of haunting anxieties. To swallow these pills is to change our state of consciousness. We forget. Then we sleep.

  









  

The Insomnia Epidemic: Let There Be Light, But Not 24/7

     More than 30% of adult Americans, about 40 million people, complain of difficulty sleeping.  For most of these individuals,

treatment  begins with medication. This tells us two things. Sleep is a big problem and a big business. These two aspects  of the ecology of sleep create  a complicated calculus in an already enormously complex field. But I think it is possible to keep the two issues separate and tell a few good stories in parallel.  It must be said that the cultural influences on the medical  community in deciding what constitutes  normal and disordered sleep are profound.  While all medical conditions are culturally bound, the fact that sleep is a universal behavior (that takes many forms and can be willfully modified) in addition to a biological one, makes its conceptualization  particularly susceptible to the vagaries of a given era’s customs and beliefs.  

     So how does one of the most basic biological functions become so disordered?  After all, what could be more natural than sleep?

     The first thing you notice when digging into what we know about sleep is how little we understand. The function of sleep, a state that occupies one third of our lives, remains unclear. Why is sleep necessary for our survival?  Why do we dream?  Sure we have made some connections by observing what happens to people who are sleep-deprived or perform shift work. Clearly physical and cognitive function take a hit. Medical interns working on the night shift are twice as likely as others to misinterpret hospital test records that could endanger their patients.  The Exxon Valdez oil spill and the Three Mile Island and Chernobyl nuclear power plant accidents were attributed in large part to the consequences of compromised night shift workers. We know memory and learning is impaired. Protein synthesis that produces the building blocks needed for cell growth and repair is markedly diminished.  But theses are crude observations, not understanding.   

     The second thing you realize, and this boggles the mind, is that almost everything we do know about human sleep has been learned in the last fifty years. Unfortunately, like the first beliefs in any discipline, many of the early theories about our sleep were wrong.  Until recently, humans were thought to be different from all other animals in having sleep that is consolidated into one continuous nocturnal episode.  This notion of uniquely human sleep held sway until the early 1990’s when Thomas Wehr, a sleep researcher at NIMH inadvertently stumbled on something that changed everything, or should have.

     Wehr selected healthy untroubled sleepers who were accustomed to 16-17 hour days and 7-8 hours of sleep, a routine that many of us live by or envy because we get less sleep. He exposed them to ten hours of light and fourteen hours of dark per day and watched what happened to their sleep. This ratio of light to dark (10:14) mimics the natural light of a typical winter day in a temperate climate.  Initially they slept for 11 hours per night, suggesting a chronic sleep deficit, and then settled into an average of 8.9 hours each night. By the fourth week Wehr saw something that wasn’t supposed to happen in humans. They all developed a sleep pattern characterized by two sleep sessions. Subjects tended to lie awake for one to two hours and then fall quickly asleep.   After about 4 hours of solid sleep, they would awaken and spend one to two hours in a state of quiet wakefulness before a second four hour sleep period. 

     This bimodal sleep has been observed in many other animals.  One such creature turns out to be pre-industrial man. Only recently have anthropologists and historians scrutinized the sleep of other cultures, earlier centuries and prehistoric humans.  In the remarkably informative “At Day’s Close, Night in Times Past”, Roger Ekirch unveils nocturnal life in the pre-industrial west.   Drawing from a broad range of sources he found a trove of evidence documenting our history of bimodal sleep.  Until the late 1700s, and the widespread use of artificial light, people retired to bed soon after sun down and entered what was called “first sleep.”  They would awaken three or four hours later and enjoy a couple hours of quiet. During this time they often prayed, chatted about dreams and had sex. A French physician described this time between  sleeps as a particularly good opportunity for sexual intimacy when couples “do it better” and have “more enjoyment”.  The middle night interactions seem to have been essential for social cohesion.  This was followed by “second sleep” that again lasted 3-4 hours and ended with sunrise.

     In fact a study of contemporary cultures across the globe reveals a wide spectrum of sleep habits. Some anthropologists now speak of three sleep cultures: monophasic cultures (the West where one consolidated sleep period dominates), siesta cultures (where one afternoon nap is added in the afternoon, the word siesta meaning the 6th hour) and polyphasic cultures (China, Japan, India where multiple naps throughout the day of varying lengths are the norm).

     Researchers have replicated and expanded on Wehr’s work.  Several studies have taken subjects to deep underground bunkers free of any artificial light in order to observe our internal clock’s rhythm.  Again, they observe this biphasic pattern.  Subjects sleep in two  four hour solid blocks separated by a couple hours of meditative quiet during which there is a remarkable surge of prolactin, unseen in modern humans.  The participants report feeling so awake during the day that it is as if they experience true wakefulness for the first time.

 So we find ourselves in a somewhat perverse situation.  We have not evolved to naturally drift rapidly into one continuous nocturnal snooze.  But according to the medical community and the pharmaceutical industry, if we don’t do this, we suffer from a sleep disorder that merits medicating.  However, if you ask any sleep expert how some people seem to fall asleep quickly and sleep continuously for seven or eight hours they’ll say that such a sleep pattern  is characteristic of chronic sleep deprivation.

     We evolved in an environment of alternating light and darkness and developed internal clocks to manage in such conditions. Every known organism with two or more cells has an internal clock.  In this regard we are not unique.  It is our use of artificial light to extend our day and defy our natural rhythms that distinguishes humans. We have just begun to understand the consequences of this Promethean sin. Sleep deprivation has been linked to obesity, hypertension, insulin resistance, cardiac disease, compromised immune function and depression. In the same way that food products/supplements are replacing normal eating with dire health effects, sleep continues to be condensed by the 24/7 culture.  The recent rapid growth of a new category of medications that promote wakefulness makes one wonder if sleep will soon be optional or ultimately obsolete.    

        

So what are you supposed to do if you?

     The constraints of work schedules and family responsibilites make radical changes in sleep-wake timing difficult. Here's some guidelines:

1. Abandon the idea of going to bed for 6-8 hours of sleep at night (unless this works for you).
2. Get a feel for what your sleep cycle looks like. If you wake up before you need to, get up. This is probably a natural cycle end.  You will make up for lost nighttime sleep with a nap(s).
3. Napping Guidelines:

·      Timing: Afternoon (3-5 PM) Proven to provide more sleep efficiency, more slow wave sleep, and less time to fall asleep

·      Duration: Optimally 10 – 20 minutes. People experience greater cognitive impairment due to sluggishness after a nap of 30 or more minutes than that due to sleep deprivation.

·      The full benefits of naps comes with habitual napping. Stick with it!

       4.  If possible, when you feel like reaching for that afternoon caffeine fix, take a nap. 



     In the next blog I will take a look at the impact of the pharmaceutical industry on our sleep culture.

    

 

Lipitor's Legacy

     On the first day of medical school we were told that half of what we would be taught would be proven false. We just didn't know which half.  If people knew that they might take medical gospel with a grain of salt. But we all have a need to believe in experts, especially when we're sick. Trying to swim through the medical literature to find out what's what is difficult enough for the highly trained medical researcher. And sometimes things are only half wrong.

     Statins (cholesterol lowering drugs) are the most widely prescribed medications in the US, taken by over 40 million people.  The story of how this group of medications climbed to such prominence is a perfect example of a therapeutic intervention based on false assumptions that has life-saving effects.

     Coronary heart disease (clogging of the arteries that feed the heart causing heart attacks) is the principal cause of death in the developed world.  Atherosclerosis (the accumulation of plaque on the walls of the coronaries) is the primary disorder in coronary heart disease. Researchers found an association between elevated blood LDL cholesterol and increased atherosclerotic disease. Statins were observed to lower this bad cholesterol and reduce coronary heart disease. Eureka! Case closed.

     But there is no apparent association between coronary events and the level of LDL reduction. In fact many patients who achieve recommended LDL cholesterol goals still  develop the complications of atherosclerosis. So what gives?

     It so happens that statins do many things in addition to lowering cholesterol.  They reduce inflammatory responses and our tendency to form clots.  The atherosclerotic plaques that already exist in our coronaries are stabilized by statins so they don't shed particles that plug up the heart's blood vessels. And the pathological process that occurs in the tissue that lines our coronaries (endothelium) and leads to plaque formation is markedly improved by statins. Inflammation, clotting, unstable plaque, and disease of  the endothelium are the primary causes of coronary heart disease, not cholesterol.

     And that's not all. A recent study looking at statin users after 11 years suggests that they had a lower death rate from all causes.  This increased survival amongst statin users was mainly attributed to a reduction in deaths from infection and respiratory illness, not cardiovascular deaths.

     Lipitor's legacy?  We still don't know the half of it.

Medicine's War on Dietary Fat: How America Got Fat

     The story of how dietary fat was pathologized and became the focus of US public health policy is a story about what happens when public demand for simple advice collides with the confusing ambiguity of real science.  Ancel Keys, an enormously influential american scientist who studied the effect of dietary fats on health (same fellow developed mobile meals for the armed forces in the 1940s - "K Rations") almost single-handedly convinced the american medical establishment of the need to decrease our fat intake. Where did this idea come from and why did it get such traction?

     In the 1950's the US appeared to experience the start of a dramatic increase in coronary heart disease. Keys published  his seminal "Seven Countries Study" in this context, demonstrating that serum cholesterol was strongly correlated with cardiovascular illness.  He suggested that dietary fat was the culprit, causing an increase in cholesterol which in turn triggered heart disease. This causal chain was not accepted by many in the medical community who cited flaws in the methodology of his study. But the skeptical camp was eclipsed by the politically adept Keys. By1982 the Keys ideology held sway and the US Department of Agriculture, the American Medical Association, and the American Heart Association told an increasingly health-conscious public that fat consumption had to be reduced. Americans were flooded with food products pumped up with carbohydrates to replace the fat and marketed as heart healthy foods. Unfortunately this well intentioned intervention not only stood on false assumptions, it initiated the obesity epidemic.

     Einstein once said "Not everything that can be counted counts, and not everything that counts can be counted."  It turns out, this applies to cholesterol. Not all LDL cholesterol is created equal. In fact, LDL can be divided into two (or four) camps according to size and buoyancy. Large buoyant LDL do not cause disease and usually coexist with low triglycerides and high HDL levels. This profile is known as Pattern A. On the other hand, small dense LDL are usually found with high triglycerides and low HDL. This B Pattern does form plaques in coronary arteries and causes heart disease.

     Now for the kicker. Dietary fat generally increases large buoyant (benign) LDL. Dietary carbohydrate increases small dense LDL! In other words, the mantra dietary fat is causing heart disease and obesity is a myth.  And when your doctor gives you an LDL cholesterol reading, you don't know what it means. You need to know how much of what type of LDL (the test is available at Quest).  This is not to suggest you go on a saturated fat binge, but let's take a look at what the data tells us.

• Reducing fat and increasing carbs (especially refined carbs) leads to weight gain and a metabolic state that favors a worsening of atherosclerotic heart disease
• Reducing carbohydrate, but not saturated fat, improves the disordered blood fat condition
• Despite conventional wisdom that reducing all saturated fat is beneficial for cardiovascular health the evidence is lacking
• In the Seven Countries Study the regions with the highest coronary heart disease (Finland) and the lowest (Crete) had the same amount of total fat intake, about 40%, the highest amongst the 16 populatios (yes 16, Keys only included 7!)
• While there is no question that trans fats are associated with increased heart disease, total fat is not

     So over the past 3 decades, while fat consumption has steadily decreased, the prevalence of obesity and type two diabetes has skyrocketed and cholesterol-lowering medications have become a multibillion dollar per year enterprise.

     In the next blog I will discuss statins, those cholesterol lowering medications, and why they may be really good for you. It has nothing to do with cholesterol!