Saturday, July 11, 2015

Caution, Patients: Large Studies May Be Hazardous to Your Health
(and Incur Unnecessary Costs for the Health Care System)

When it comes to providing clear explanations of complex medical and health-related issues, there is no one better than Aaron Carroll. As a person who is regularly looking for answers in these areas, I am a huge fan. I watch his videos on Healthcare Triage, read his articles in the New York Times, and follow him on Twitter. His excitement about food, ideas, travel, and the latest exploits of his kids are fun to read about. You probably sense that there is a “but” coming – and here it is: Aaron’s enthusiasm about large studies makes me uneasy.

Large studies inform us about what happened to a particular group of individuals under a specific set of circumstances. They can provide guidance for medical practitioners when they deal with individuals who appear to be similar to that group; they can give doctors an idea of what to look for. What can large studies tell doctors for certain about any given individual? Absolutely nothing.

Problems arise when the guidance provided by studies morphs into a hard-and-fast rule about what must always or never be done. In some cases conclusions from studies are over-generalized and made to apply to situations which are beyond the scope of the studies.

Arthroscopic Surgery Isn’t Going to Fix Your Knee,” a recent HCT video, talks about a recent review and meta-analysis of studies on arthroscopic surgery for degenerative knee. Both the title and the video itself make it sound as though arthroscopic surgery is always a waste of time and money. Yet the studies were really about attempts to repair degenerative knees. They weren’t intended to address the issue of repairing knee injuries.

When patients fail to conform the rules derived from large studies, they may have great difficulty securing proper medical treatment. Here is what happened to a friend of mine, a man in his mid-seventies, a natural athlete who was then playing racquetball a couple of times a week. One afternoon he tripped as he was going up some stairs. In instant he went from normal to hardly being able to walk.

After an x-ray at the hospital, he went to a local orthopedics practice where the first doctor said, “You have a torn meniscus. It can be repaired with arthroscopic surgery – we do them all the time.” That sounded fine to my friend but when he was passed along to a surgeon in the same office he got a different pitch. The surgeon said, “You have advanced arthritis and surgery would not do any good.” He then gave my friend a cortisone shot, which had no effect on his pain or disability and told him that he would probably require a knee replacement in the foreseeable future.

The story about advanced arthritis didn’t sound quite right to my friend. Before the injury, he had been able to squat down and remain there for minutes at a time (the pose of cowboys in front of a campfire). He sought out a second orthopedist. This doctor, a woman, said, “We don’t normally do knee surgeries on people in their seventies but I think you are the exception.” Several weeks later, after performing the surgery, she said, “This knee was like a Ping-Pong ball. I’ve seen people in their forties who didn’t have knees as good as this.” This was an injury, not advanced arthritis. The first surgeon had lied because he didn’t want to operate on a man in his seventies. My friend went back to playing racquetball.

Doctors today have impossible schedules. They see each patient for fifteen minutes, if that. Under these circumstances, over-generalizations and rules based on large studies can become a tempting substitute for close observation and careful analysis of an individual situation. The likely consequences are improper care for the patient and unnecessary expense for the health care system. In thinking about my friend’s experience I have sometimes wondered how many older people with injured, but otherwise healthy, knees have been steered into having knee replacements when all they needed was a simple arthroscopic surgery.

Patient Stereotyping at the Optometry Clinic

A friend of mine, now in his eighties, had been unhappy with his distance vision for several years. Each year or so he had his eyes tested at an optometry clinic run by a nearby university where there was a school of optometry. On these occasions he would ask whether he should consider cataract surgery. Each time he was told that it would probably do no good because his distance vision was not that bad. This year he learned that he had drusen, yellow deposits under the retina. These marks, he was told, might be early signs macular degeneration, which might be contributing to his vision loss and would not be helped by cataract surgery.
 
At the optometry clinic, my friend’s eyes were examined by students whose work was then checked by a faculty member. Some of these students were observing certain eye conditions on a live patient for the first time; they had only previously seen them in textbooks or online. In addition, typical patients at the clinic were other students or faculty in their thirties through early sixties. Relatively few older people were seen there.

My friend decided to get a second opinion. He visited an optometry practice that uses state-of-the-art tests and equipment to examine and treat conditions affecting vision. There, the typical patient is in their sixties or older and the doctors on staff have had years of experience treating such patients. The doctor who saw my friend told him that he was a good candidate for cataract surgery; that there would be a significant improvement in his distance vision. After looking at the drusen, he told my friend that there are different types; the kind my friend had might never cause any vision problems at all. 

My friend just got cataract surgery and, after less than a week, already has better distance vision than he had had with his glasses.

Monday, April 27, 2015

An Interlude in Padua

Prato della Valle is a huge open space at the edge of the old part of Padua. Once the site of a Roman theater and of Renaissance jousting competitions, it is the largest piazza in Italy (over 22 acres). We were there to see the Basilica di Santa Giustina, which commemorates Saint Justina, an early Christian martyr and the patron saint of the city.

Inside the church, marble floor tiles are laid in an illusionistic pattern, a surprisingly modern touch. The church is supported by massive pillars that rise to graceful arches overhead. In the late afternoon silver-grey light filtered down from windows in the domes high above. A pigeon had gotten inside and cooed somewhere out of sight.

As we left, a monk came out to lock the doors. He had an easy smile with one tooth angled inward and asked us where we were from. We told him and asked him if he was Italian (in Italy, priests and nuns come from all over the world). “Italianissimo!” he answered proudly. Then his cell phone rang and he had to go. We walked across to a restaurant where we could watch the sun go down over the piazza.

There are moments when the diverse strands of my experience seem to be woven together into a coherent whole. This was one of those moments.

Tuesday, March 31, 2015

Bells, the New Challenge, and Going Back to P90X

Last spring I quit going to our local Y. Even with very intense workout I had been doing - a combination of weights, cardio, and stretching - my condition was not improving; I wasn’t losing weight or body fat or getting stronger. Clearly, I was in a rut. I decided to check out the Iron Pit, a weightlifting gym where I used to work out with a personal trainer several years ago.

About the same time I read an article by Daniel Duane about his own experience with strength training (“Fitness Crazed,” NYT 5/24/2014). At the age of 40, Duane found himself fat and weak and went on a quest for an effective exercise program. After trying and rejecting a number of approaches (including P90X), he settled on a weightlifting program designed by Mark Rippetoe, Duane did three workouts a week based on five lifts: the squat, deadlift, power clean, bench press, and standing press. He did three sets of five reps of two or three exercises each time. Each workout, he found that he could lift a little bit more until, after a year, he could squat 285 pounds, dead lift 335, and bench press 235. (This Men’s Journal article gives a more detailed account of his progress.)

I decided to see whether this approach would work for me. Doug Ballard, one of the owners of the Iron Pit, got me started on the squat, deadlift and bench press using a 45 lb. Olympic-sized bar. To Duane’s basic five I added a bunch of others plus cardio twice a week on a cross trainer to keep my heart rate where it should be. (Duane is actually a biker and a surfer so weightlifting isn’t his only physical activity.) In order to burn enough calories, I need to be doing at least 6-7 hours a week of exercise so I rounded the program out with some DVD workouts, mostly P90X plus some Bob Harper routines. I’ve been doing this for about nine months.
 
Starting any exercise regimen gives you new insights into your physical advantages and disadvantages. To do a squat with correct form you need to push your hips back as you lower your upper body, keeping your chest as vertical as possible. Near the bottom you need to curve your lower back upward, sort of like a duck’s tail. I have a short torso so I don’t have much lower back to work with. I do as well as I can but I struggle with this one. Deadlifts, on the other hand, feel pretty natural, probably because my legs are strong. I’m up to 110 lbs. and expect to go higher soon.

Unlike Daniel Duane, I don’t find that I can add a little more weight each time. Progress is sporadic, especially if I have to take a few days off because of a trip or some other distraction. In terms of physical condition, my weight and body fat percentage are the same but I’ve lost half an inch from my thigh and a quarter of an inch from my upper arm, nice but nothing to write home about. The main improvement I notice is with my posture. Working the back muscles this hard pulls my shoulders back and down; I’m seeing more of my rib cage than I have since grade school. Also, when I go back to P90X I find that I’m doing the same exercises with heavier weights (still can’t do an unassisted pull-up though). 

 
One of the DVD workouts I do features kettlebells. These are round or squarish weights with handles at the top. Typical moves involve swinging them in an arc, though you can also use them for regular exercises like curls and cleans. The swinging motion means that you get into parts of the muscle that normal strength moves don’t hit. Bob Harper’s 45-minute kettlebell routine also includes jumping jacks and pushups. 


When it comes to strength there’s no magic; if you want to improve you need to work harder. That means lifting weights close to the limit of what you can do. Doing many reps with a 3- or 5-lb. weight, as is often recommended for people in their 60s like me, might help to keep you flexible but if you want to be strong you need to get up into the 10-or-above range. As you get older, strength training may be the most important type of exercise of all. I’ve noticed that Bob Harper, when he creates workouts for DVDs, uses light or medium weights; when he exercises for himself he goes to CrossFit and does powerlifting.

Tuesday, December 16, 2014

A Question for Doctors: Are Sick Patients More Important Than Healthy Patients Who Are Trying to Stay Healthy?


Now that I am in my late 60s I often worry that I am losing it. Incidents involving misplaced keys or forgotten grocery items take on an enhanced importance. But when I tell myself to step back from the panicky emotion and look at the present situation in a larger context, I can recall that I used to make the same mistakes in my 20s and 30s. It’s not so much actually losing it but anxiety about losing it that is at work here.

For doctors and medical administrators, anxiety about what might happen can cause temporary blindness to what is actually happening. In my conversation with the Medicare doctor it was clear that he was extremely concerned about harm that might come to women when estrogens were prescribed inappropriately by their doctors. For example, the WHI 2002 study did show that older women with existing heart disease should not be initiating hormone replacement therapy. In order to protect those who should not be taking estrogens, Medicare has erected a series of hurdles that must be negotiated each year by all patients wanting to take these medications (and their nurses and doctors). This situation means that many women who could avoid menopause symptoms (and possibly be helped by beneficial side effects) are excluded from taking a drug that could improve their quality of life and might actually extend their lives (depending on what current and future research shows).

The same reasoning seems to be at work in our current version of preventive medicine, which applies treatments and test to millions of healthy people so that a few can avoid illness. Jeff Wheelwright discusses this situation in an article entitled, Risky medicine: Misunderstanding risk factors has led to massive overtreatment of diseases people don’t have and probably never will.” If 100 people are treated with statins for 10 years only 4 will be saved from having a heart attack. For every 1000 women regularly screened with mammograms over the age of 50 one life is saved. Often overlooked is the fact that these interventions harm a certain number of healthy people.

The medical community needs to take a step back and ask itself questions like these:

- Is it more important to protect the sick or to maintain the healthy?

- How many healthy people are we willing to put at risk in order to spare one person
     from disease or death?

- How many healthy people are actually being harmed by any given intervention?

- To what extent can we accommodate the needs of both groups?

- How much is all of this costing?

Doctors dedicate their lives to helping patients. From med school onward they learn to interact and empathize with those who are suffering from illness. In the larger world, however, most of us, most of the time, are healthy. If that were not the case, no health care system could ever take care of all of us.When medical policy decisions are made,­ healthy people who are trying to stay healthy need to become part of the calculation.

What Happened Next

Continuing... 

Like many people who live far outside the Beltway, I tend to think of Medicare as an undifferentiated part of a faceless federal bureaucracy. After writing the letter, I kept it around for a couple of days, then sent it off to Marilyn Tavenner’s e-mail address on Thursday, December 11, in mid-afternoon.

That evening I received a call from Humana saying that my request for Premarin had been approved for one more year. This year my doctor’s nurse had requested the drug for me twice and been turned down twice. After that, I had had to file a grievance; my doctor and I each wrote a letter to Humana. One of those last two attempts had succeeded. This sequence of events is pretty typical of our experience in the three years we have been doing this.

In response to my e-mail to Medicare, I expected to receive a form letter or, at most, an e-mail from the PA of a PA well down in the food chain. I was therefore quite startled to find a message, sent the following morning, from a doctor at Medicare saying that someone would be in touch with me. If I wanted to speak to him directly, he said, I should e-mail my phone number. I wrote back and told him that, since I had received the approval from Humana, the immediate situation was resolved but that I was frustrated at having to go through this process each year and concerned that, at some point, I might not be able to get this medication at all. I included my telephone number but said that I didn’t necessarily need to talk with him.

Minutes after that message went off, the phone rang. It was the same Medicare doctor. Not expecting an important call, I had been playing a brain game on the computer. I had to scramble for a few seconds to get rid of my headphones so I could focus on what he was saying. Our conversation was quite friendly, although we were approaching the issue from different vantage points. His primary concern was to reassure me that I would always be able to get Premarin, although it didn’t sound as though the appeals process would be going away anytime soon.

When I asked why there were so many obstacles for women wanting to use this medication, he said that Medicare wants to be sure that doctors and patients understand the risks involved; some doctors prescribe estrogens for patients who really should not take them. I said that some doctors refuse to prescribe these drugs, even for women would benefit from using them. After WHI 2002, many women were persuaded to stop hormone therapy. (One woman I know had terrible problems with insomnia; another is now taking a bisphosphonate for bone density, which poses its own risks.) We agreed that it would be better if there were some way of providing easier access for women who can and are willing to take estrogens, while discouraging those for whom it is truly a risky drug. He thought that electronic records might make it easier to do this.

At the end of our conversation I had the sense that the Medicare doctor had really heard what I was saying and would continue to think about it. Whether any actual changes will come about is, of course, another story.

Monday, December 15, 2014

"Humana, I Still Want My Premarin – So I Wrote to Medicare"

December 11, 2014

Marilyn Tavenner, Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

Re: Problems Getting Medication

Dear Ms. Tavenner:

Recent advances in the field of medical genomics demonstrate the wide variations from one person to another and point to the need for a more individualized approach to health care. In spite of these developments, the advice issued by Medicare to insurance companies continues to rely on large studies that make generalized recommendations for diverse groups of individuals. I am a 68-year-old woman with no heart disease, cancer, or diabetes; I do powerlifting, cardio, and P90X workouts. Yet according to Medicare’s current approach, the recommendations for me would be the same as those for a woman my age with heart disease and diabetes.

This one-size-fits-all approach comes back to haunt me each year when I have to ask Humana, the provider of my medications, to make an exception and allow me to take Premarin, a drug that I have been taking for 35 years since I had a complete hysterectomy at the age of 32. Apparently Medicare tells Humana that Premarin is a high risk medication that should not be given to patients 65 and older. Will Medicare and Humana compensate me if I go off Premarin and get osteoporosis, hot flashes, and other symptoms of menopause? Of course not.

Medicare’s recommendation is evidently based on WHI 2002, a study that did not deal with estrogen-only therapy, was poorly presented to the public, and whose results have been called into question by subsequent research. I have written about this in my blog post, "When Emotion Trumps Science: the Latest on Hormone Therapy," http://bit.ly/18RqHfB. To give just one example, a Danish study reported in the British Medical Journal 10/09/2012 reached this conclusion after observing 1006 women:

After 10 years of randomised treatment, women receiving hormone replacement therapy early after menopause had a significantly reduced risk of mortality, heart failure, or myocardial infarction, without any apparent increase in risk of cancer, venous thromboembolism, or stroke.

So estrogen is not only preventing menopause symptoms for me but may also be protecting against heart disease, which runs in my family. In spite of these more recent results, Medicare continues to behave as though WHI 2002 were the final word on HRT and even to generalize its findings to cases like mine (estrogen-only versus estrogen-plus-progestin) to which they are not relevant. There has been little acknowledgement of the harm done to women by the study and the way it was presented to the public. Millions of women have suffered menopause symptoms needlessly and have been denied the possible benefits of estrogens. Some scientists at Yale believe that as many as 50,000 women may have died prematurely of heart disease between 2002 and 2011 because of discontinuing estrogen-only therapy.

I do not have any major illnesses and I rarely get sick at all. My good health has probably already saved the health care system thousands of dollars. It would seem to be in everyone’s best interests to allow me to continue what I have been doing. I hope that you will be able to help me with this situation. I have heard from other women who have had the same experience. Thank you for taking the time to read this message.

Yours sincerely,

Gretchen Kromer

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