Basic Assumptions

Lost in the health-care debate is an examination of basic assumptions. Consider two basic assumptions. One is that there is currently a free market in health care and that the free market has created our health care problems. The other basic assumption is that more health care leads to improved health. What, if these assumptions are wrong?

In a provocative essay in the Atlantic Monthly Myth Diagnosis Megan McArdle asks, “Everyone knows that people without health insurance are more likely to die. But are they?” McArdle’s writes:

The possibility that no one risks death by going without health insurance may be startling, but some research supports it. Richard Kronick of the University of California at San Diego’s Department of Family and Preventive Medicine, an adviser to the Clinton administration, recently published the results of what may be the largest and most comprehensive analysis yet done of the effect of insurance on mortality. He used a sample of more than 600,000, and controlled not only for the standard factors, but for how long the subjects went without insurance, whether their disease was particularly amenable to early intervention, and even whether they lived in a mobile home. In test after test, he found no significantly elevated risk of death among the uninsured.

How can this be? Simple, there are drugs and surgeries that harm and there are alternatives to both, including no treatment at all.

Consider the drug Fosamax. Almost everyone believes that there is an epidemic of osteoporosis and osteopenia (thinning of bone mass) and that effective therapy is to treat the disease with drugs such as Fosamax. But, a belief is not a fact.

For most individuals, bones continue to mineralize even after we have stopped growing, sometime after puberty ends. Usually, by the age of 50 our bones start to lose mineralization. Often this process is more pronounced in women, but this demineralization is normal and not pathological. The risk of a pathological condition can be reduced by both exercise and diet. What if we have medicalized a normal condition (osteopenia) and harmed millions of Americans in the process?

In 2008, bisphosphonate sales such as Fosomax exceeded $8 billion and over 37 million prescriptions were written for these osteoporosis medications. Fosomax has important side effects:

1. During the time a patient is on the drug, their body’s own ability to remineralize their bones is completely suspended and perhaps lost forever.

2. According to Kathleen Daniels:

One study concluded that women using Fosomax are almost twice as likely to develop irregular heartbeat, or atrial fibrillation. Another team found an increased incidence of a jaw tissue infection, and in a large seven year study, Canadian researchers found that this class of drugs nearly triples the risk of developing bone necrosis, that can result in “incapacitating pain.” A fairly strongly worded FDA alert suggests that use of bisphosphonates can lead to “the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain” and that health professionals should consider temporary or permanent discontinuation of the drug.

3. The Fosamax drug insert admits that “taking this drug increases your risk of fracturing your femur, or thigh bone, even during low impact activities.”

It is a safe bet that many of the millions of Americans (mostly women) have no idea of the side effects of these drugs. How could they? They go to a doctor for a routine check-up. Their doctor recommends a bone density screening. The screening comes back that they are at risk; the doctor tells them with assurance that these drugs will help reduce their risk of a hip fracture. Their doctor’s visit was probably insured, the drug is covered by insurance, and the whole sequence of events takes place with minimum interaction with the doctor. And sadly, there is a vague satisfaction among the patient that they have a medically recognized condition. If you doubt the latter, visit Florida, and observe seniors engaged in conversation about their latest doctor visits.

But what about hip fractures?  For an elderly woman such an event can be life threatening. Pharmacist Jennifer Montgomery has dissected the statistics and found that among “100 women taking Fosamax for 3 years, the drug will prevent one woman from getting a fracture.” Others will experience the devastating negative side effects previously described.

Alix Spiegel’s ”How A Bone Disease Grew To Fit The Prescription” explains how Merck helped to convince millions of Americans that a normal condition of aging needed to be treated by a dangerous drug. The story begins in Rome in 1992 where:

A group of osteoporosis experts gathered under the auspices of the World Health Organization. The meeting had been organized because professional opinion about how to diagnose and measure osteoporosis was all over the map. Doctors and researchers didn’t even have a shared view of how osteoporosis should be defined.

For a long time doctors and researchers were only able to diagnose osteoporosis after a woman experienced a bone fracture. But by the early ’90s technology had evolved, and bone scanners made it possible to determine whether the bones were weak before any fractures occurred.

The question before the experts in Rome then was this: Since after the age of 30 all bones lose density, how much bone loss was normal? And, how much put women at risk and therefore should be considered a disease?

Anna Tosteson is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and Dartmouth Medical School who attended the meeting. She says that over a two- or three-day period the experts in the room went back and forth and back and forth, looking at research and trying to decide precisely where on a graph of diminishing bone density to draw a line.

“Ultimately it was just a matter of, ‘Well … it has to be drawn somewhere,’ ” Tosteson says. “And as I recall, it was very hot in the meeting room, and people were in shirt sleeves and, you know, it was time to kind of move on, if you will. And, I can’t quite frankly remember who it was who stood up and drew the picture and said, ‘Well, let’s just do this.’ ”

So there in the hotel room someone literally stood up, drew a line through a graph depicting diminishing bone density and decreed: Every woman on one side of this line has a disease.

Then a new question arose: How do you categorize the women who are just on the other side of that line?

To address this issue, Tosteson says, the experts — more or less off the cuff — decided to use the term osteopenia. Tosteson says they created the category mostly because they thought it might be useful for public health researchers who like clear categories for their studies. They never imagined, she says, that people would come to think of osteopenia as a disease in itself to be treated. The chairman of the meeting, John Kanis, of the WHO Collaborating Centre for Metabolic Bone Diseases, says the same thing.

Nevertheless, 17 years later (Katie) Banghauser, of Richmond, Va., a woman whose bone density is just a hair away from that of the average healthy 30-year old, is not only medicated for osteopenia but literally spends her days worried about breaking a bone.

“I used to run marathons, and I would fall and trip on broken sidewalks,” she told me. “And you know initially before I had this diagnosis I didn’t think anything of it. But now every time I fall I get up and think, ‘Oh, good, I haven’t broken anything.’ ”

“I’m much more aware of making sure I lift my feet up and I don’t trip on the sidewalks, but you know, if I didn’t know that I had osteopenia, maybe I wouldn’t be so cautious.”

In other words, by definition, anyone who does not meet the bone density of a thirty-year old woman is defined as diseased. No wonder the pharmaceutical companies are on board with health-care reform. More health care means more doctors visits and an expanded market for their often useless and dangerous snakeoil.

Will our health improve with a policy that assures us of all the Fosamax we don’t need to take? If this is an example of “health care,” do Americans really need more of it? This basic question is not being addressed. And until it is, this unaddressed question threatens not only our health but the solvency of the nation.

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7 Responses to Basic Assumptions

  1. Chris Claypoole says:

    I have seen adverse reactions to ill-advise prescriptions first-hand. My mother-in-law, who is now 91 years old, and has lived with us for thirty years, has a variety of conditions related to aging, like arthritis and hypertension. She takes some fairly standard meds for those. Occasionally, she has had trouble with swelling of her lower legs, and (a few years ago) had shingles.

    The prescriptions her doctor gave this elderly woman were strong enough to make her violently ill in the one case, and give her serious and prolonged hallucinations in the second. She’s feisty, and her mind is sharp, but she NINETY-ONE, doc! Don’t prescribe heavy-duty meds; her system can’t cope.

    But that seems to be all they know.

    In June 2008, I was in a car accident that injured my back. After nearly a year of going to spinal surgeons and “pain management” clinics, I got fed up and went to a chiropractor recommended by my wife’s older sister. In less than three months I was able to go through normal (non-athletic, non-weight-carrying) activities without pain for the first time since the accident. AMA delenda est!

  2. Lyn says:

    Great perspectives, Barry. Perhaps because I am one of them, I find more and more people becoming conscious of the risks of heavy-handed surgeries and pharmaceutical therapies, who have thus turned to more natural approaches and an overall choice of self-care whenever possible.

  3. Frankvv says:

    Barry,
    I concur that big pharmacy and the medical communities are in cahoots with one another. My sister-in-law works for a large pharmaceutical company, and they have entire sales teams that work on “educating” the doctors on the different products available, and then work on getting a commitment that they will prescribe these pills. Then the pharmaceutical rep goes to the local pharmacies in a Doctor’s backyard and lets the pharmacist know that Dr.“X” will be prescribing drug “A”, and that they should stock up on it. It feels to me like an opportunity for those who have less than perfect morals to engage in some “reward” schemes to ensure that the drugs get prescribed at the levels the pharmaceutical sales rep needs in order to meet sales targets. Again, I am not making any accusations here, just an observation

  4. Frankvv says:

    Barry,
    One more comment if I may – you suggested that many of our medical conditions could be eliminated with proper diet and exercise, and that point is so on the mark. I am 52 (almost) years old, and at 48 I was 30 pounds over weight and beginning to have blood pressure issues. I got of my proverbial donkey and began to do something about it and quickly began to shed pounds – just by walking (power walking) 3 miles a day. By age 51 I pushed up my physical routine several notches. I run 25 to 30 miles a week and go to the gym on the days I am not running. My blood pressure has dropped to a nice low level and I am off blood pressure medicine. I am also eating much healthier – no soda at all – and I have lost another 20lbs. I am now 6 pounds from my wedding weight when I was 22. I never thought I’d see the day. The down side – I had to buy a whole new wardrobe of dress pants for work. 

    PS – Not sure if you saw the Mountain Dew ad in the Wall Street Journal yesterday promoting that the soda was now using “real sugar” instead of corn syrup. Interesting

  5. Jim D. says:

    Sounds like the egos of the medical establishment are out of line and answering to the egos of those who look outside of themselves for answers. I’m not suggesting that medicine isn’t good for treating the truly ill, because there are people out there who have real problems. Just that if we truly fix our diet and exercise issues, a lot of these “problems” go away, and these medical sycophants lose their jobs. After all, if the problems go away, they’ll be stuck researching something that doesn’t draw a lot of dollars. But we look to medicine for quick fixes to issues we don’t want to do the real work of fixing right. I’ve never found a situation where a quick fix truly replaced the work of doing it right to start with.
    The recipe for good health hasn’t changed in more than 100 years:
    1. Eat right
    2. Get moderate exercise
    3. Go easy on the alcohol
    4. Don’t smoke.
    Follow that prescription, and you’re likely to stay on the “right” side of whatever line they draw. Of course the medical establishment will hate you for it.

  6. QN says:

    Professor B,

    I could not agree more with your challenge on the assumption that more health care is better. I believe that future comparative effectiveness studies will be beneficial to validate your points. In the mean time I want to challenge the other assumption that there is currently a free market in health care.

    Health care became a regulated industry on July 30, 1965 when the Medicare and Medicaid Service programs were signed into law. Most Americans and even Congress do not know the depth and breadth of reach Center’s for Medicare and Medicaid Services (CMS) has since that time, nor do they realize how the signed healthcare bill will now ultimately allow CMS to take complete control of the healthcare industry.

    Some may argue that this is a good thing because CMS will mandate comparative effective studies to help determine the best treatment modalities for disease and conditions in the name of quality outcomes. However CMS tends to be very myopic, when it comes to research and focuses on conditions that are costly to the Medicare program.

    To gain an understanding of the future of healthcare I believe one needs to go no further than the current home healthcare sector. Home healthcare received a complete overhaul in 1999 when CMS instituted regulations which mandated how agencies operate and provide care in order to receive Medicare reimbursement. Since that time there has been an overall decline in clinician practice and healthcare innovation as well as an increase in Medicare fraud and abuse. One would argue that this only impacted care to 65 and older however most insurance companies follow Medicare guidelines, the 1999 regulations basically impacted any adult receiving home healthcare not related to maternity conditions.

    I believe the main causative factor in the overall decline of home healthcare practice and innovation is the amount of paperwork and bureaucratic processes which need to be followed in order to receive reimbursement for care provided to Medicare beneficiaries. The most common complaint is related to the Outcome and ASsessment Information Set (OASIS), an assessment form that is mandated by CMS for Nurses to complete which dictates how the agency will be paid and the type of care and process measures that need to be implemented for the beneficiary. Most time is spent on the OASIS rather than good nursing practice and patient care. Care has become fragmented and there has been a loss of holistic approaches. This is due to the fact that if it is not on the OASIS or not covered by Medicare than it does not get addressed.

    When research and/or improvement programs are instituted it is often related to the OASIS items since it has a scoring algorithm used to calculate reimbursement for Medicare. Most studies are to reduce costs associated to the home healthcare provided, maximize reimbursement with patient outcomes improvement as secondary results. This is the reason why there has been an increase in Medicare fraud and abuse, it is too easy to game the system. I reviewed the current state of home healthcare but it should be noted skilled nursing facilities (SNF) also known as nursing homes are in no better shape. The SNFs were actually the first to experience the CMS overhaul in the early 1990’s and have very similar requirements as home healthcare. For over 20 years now the facilities have been working on their quality measures and yet the general public continues to hear about nursing home fraud and abuse in addition to poor clinical care.

    I will end this post by simply stating more health care is not always better and that having the government control the healthcare industry is not an option either. It could be argued that the government has had control of health care for years and that the new healthcare bill just puts it in writing so that CMS can expand the home healthcare and SNF program requirements into hospital facilities, physician offices and ambulatory care centers. Regardless striking a balance between too much and too little health care will always be a challenge.

  7. Bob G. says:

    After reading this I became aware that I may have “after long day at work, semi-blues, reality bites” syndrome.

    Fortunately, I saw a advertising commercial on TV (it had a lot of smiling people in parks with ice cream cones and children) that told me I had LD-RB syndrome (Long day – Reality Bites)syndrome and that Chearoxol-Up could help.

    After I consulted my doctor, I learned that I should not take this if I have high-blood pressure, am pregnant or suffer from illusions of being healthy and well. Other than the fact that in some cases, taking this medication could result in death… I am otherwise advised to consider this as opposed to just dealing with it!!!

    I wonder if Obamacare will provide this for me!!!

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