McGill-Queen's University Press Blog

Nortin M. Hadler on NPR

An interview with Dr. Nortin M. Hadler hosted on National Public Radio Thursday, October 4. to promote his latest novel, The Last Well Person.

http://wunc.org/tsot/archive/sot1004a07.mp3/view

Its spring 2007 release almost a foray of things to come in documentary filmmaker Michael Moore's hugely successful Sicko, The Last Well Person is a provocative look at how America's self-serving medical industry, through unnecessary intervention, turns healthy people into patients.

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Dr. Hadler is professor of Medicine and Microbiology/Immunology, University of North Carolina at Chapel Hill, and attending rheumatologist, University of North Carolina Hospitals.

Nortin M. Hadler: If There's No Benefit, Why Tolerate Any Risk? The Lessons of Avandia, Vioxx, Bextra and Baycol

Opinion
Nortin M. Hadler
ABC News
June 1, 2007

We have all grown accustomed to the scare of the week.

Each week we learn about another hazard that is lurking in our environment. We learn of something we are not doing that we must do -- or else.

We must eat fish, but not all fish. Last year if you fed your child butter you were negligent; this year if you feed your child margarine you are negligent. Tomatoes are health foods, or not.

We, the healthy, are taught that life is a minefield. We, the healthy, seem to have an insatiable appetite for scares of this sort. We leap to our own defense regardless of the reliability of the scare, the validity of the remedy or the expense.

With increasing fervor, the ill amongst us are learning a corollary lesson. The vaunted American health care system can be hazardous to your health.

First we learned that hospitals were dangerous places; if evil infections don't get you, errors by the staff might. But you don't need to be hospitalized to be at risk from modern medicine. Every week we have learned that another device or another pill was a Trojan horse, waiting to unleash some horror down the road.

Today I want to consider the question that should precede an assessment of hazard. In order to weigh a hazard, one must have a handle on the benefit.

The more the benefit, the more we might countenance some hazard. Likewise, if there were no important benefits then we would tolerate absolutely no risk.

Several common medical interventions have recently come under the gun and even succumbed to the identification of a measured, important, and putatively likely hazard that has been bellowed by the media -- often perking up the ears of the plaintiff's bar.

There are important lessons regarding the assessment of benefit in these examples:

Drugs to Treat Adult Onset, Type 2 Diabetes

Avandia is one of a newer class of drugs designed to lower the blood sugar of adults whose blood sugar is higher than is said to be good for them.

As we age, our own insulin is less effective in helping our blood sugar enter our cells to provide an energy source. Some of us have this tendency earlier than others, particularly if we have a big gut-to-butt ratio and/or we're poor.

This higher blood sugar and its fellow-travelers (higher blood pressure, higher cholesterol, and lesser wealth) are associated with earlier death, but only if any or all are particularly severe.

For over 50 years medicine has recruited the pharmaceutical industry to smite each of these "risk factors" a mighty blow in order to spare us grief. Avandia is another attempt to tackle persistently elevated blood sugar.

It works. It lowers the blood sugar. Furthermore, the earlier generations of drugs designed to do this also lower the blood sugar. They work too.

However, no one feels better for a lower blood sugar. Some feel worse or get fatter depending on the drug. And no one feels worse for a high blood sugar, except for the rare patient with adult onset type 2 diabetes who can mobilize an extremely high blood sugar.

It's like "high" blood pressure.

So Avandia does nothing for the quality of your life. Does it do something else -- save your life, or postpone the horrid complications some patients can get with adult onset type 2 diabetes and its fellow travelers?

We don't know for Avandia. However the precedents are daunting. Long-term experiments, randomized controlled trials, with earlier generations of drugs that lower blood sugar are not encouraging. One famous trial lasted over a decade.

There is no precedent for any of these drugs saving a life, a limb, an eye, kidney or anything else important. There is no demonstrable benefit except the lowering of blood sugar. Who cares?

I have practiced medicine for 40 years. I have never prescribed a pill to lower blood sugar. I still see no reason to do so. If I am disadvantaging my patients, it's to a trivial degree at most. However, I know I am sparing them known and unknown hazards.

And I won't let you measure my blood sugar or the measure of its persistent elevation, the hemoglobin A1c. I don't care, and I won't care till there is compelling science that something meaningful can be done if it is elevated.

Drugs to Treat Painful Joints

Vioxx and Bextra were pulled off the market because of data suggesting they imparted a tiny hazard for heart disease. It's perhaps a slightly more convincing hazard than that purported for Avandia, but there's little here worthy of alarm.

I am a rheumatologist. I have never prescribed Vioxx, Bextra or their cousins such as Celebrex. But I never prescribed them for reasons other than their possible effects on the heart.

Do you know that no drug of this class has ever been shown to be more effective than aspirin? Do you know that no drug of this class has ever been shown to be safer than aspirin? Only Vioxx convinced some who are swayed by tiny differences. But Vioxx never convinced me.

Why would I ever prescribe this class of drugs? I don't care if there are TV advertisements claiming magical effects like you, too, can skate on ice. I don't care if the occasional patient swears nothing else helped. I am unwilling to prescribe a drug that has no important benefits over the old standbys and has no long-term track record for safety.

I spend much more time explaining my philosophy to my patients than the seconds required to fill out the prescription, or to give a sample. By the way, neither drug company sales people (detail representatives) nor drug samples are allowed in my clinic -- and never have been allowed. I'll take the time to explain my philosophy or stop practicing medicine.

However, I am a "senior" clinician; if my students, and there are many out there, practiced the way I taught them, they'd starve. There is something horribly rotten in the United States, not in Denmark.

Drugs to Lower Cholesterol

Baycol is a statin. That's a drug that lowers cholesterol. It was pulled from the market because of about 50 cases of a complication that almost never occurs unless you are on a statin.

This is a complication that causes the muscles to die, and often the patient follows. It occurs occasionally with all statins (Lipitor, Pravachol, Simvastatin, Crestor, and others). But somehow the number of cases ascribed to Baycol lead to its banishment and not the others. After all, the common wisdom is that lowering cholesterol is too good a thing to pass up.

It is true that cholesterol is a "risk factor" in people who do not have an extraordinary family history of youngsters dying of heart disease. But it is not that much of a risk factor. If you have a particularly high LDL cholesterol (the "bad" cholesterol), and a particularly low HDL cholesterol (the "good" stuff), you are harboring a 2-3 percent mortal hazard.

That means you are at risk for living a year less than others born when you were. Very few of us have even this degree of risk. For most it is a matter of months, if you believe such a tiny risk is measurable.

It is true that these statins can lower your bad cholesterol.

It is true that maybe they can spare you a heart attack, but that's a real MAYBE.

It is also true that no study has shown it can spare me death before others born when I was born. That's true for men of my generation. There are no compelling studies for people who are not men of my generation.

Now you know why I won't let anyone check my blood cholesterol. Why bother? You can lower it, but you can't do anything for me that I would consider meaningful. I'd rather not know if I have any special risk of earlier death, even the tiny risk imparted by high cholesterol.

Merck is faced with a class action law suit because its advertising allegedly suggests benefits from Lipitor for women when there is no supporting science. I don't think there are benefits for anyone in the general population.

I have never prescribed any drug of this class.

Caveat Emptor (Buyer Beware)

I have written commentaries for ABCNEWS.com relating to the lack of benefit from stents and mammography. I will not reiterate these since they are readily available in the archives.

The lesson is obvious. We, all of us, need to demand that no drug be licensed without a demonstration that it is meaningfully effective.

Today, the game is to generate evidence of any effect. We should demand much more than evidence for a surrogate effect such as lowering cholesterol or lowering blood sugar. We should demand more than evidence of an infrequent benefit that is not that crucial. We should demand robust evidence for a meaningful effect.

Then these tiny, remote harms would be countenanced.

Then all the hype, the "me too" drugs, and the profitable silliness would be dark history.

Then we would all be better off.

Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. He is the author of The Last Well Person.

Copyright © 2007 ABC News Internet Ventures

Review: Nortin M. Hadler, The Last Well Person: How to Stay Well Despite the Health-Care System

Reviewed by David A. Bennahum
The Pharos, Winter 2007

The Last Well Person: How to Stay Well Despite the Health-Care System
By Nortin M. Hadler
McGill-Queen's University Press, 328 pages

In a remarkably well-written and stimulating book Nortin M. Hadler, professor of Medicine and Microbiology/Immunology at the University of North Carolina, challenges a number of medicine’s most cherished certainties. Written for the general public, the book should, however, be read by all physicians and then recommended to their patients. Surveying the plethora of health information and medical advice to which the average healthy American citizen is subject he writes that “The Last Well Person is written for all those well people who feel their sense of wellbeing is under attack.” p4 Hadler hopes “to inform the reader who is well how to feel well.” p4 and to accomplish that goal builds his book, as he says, on four footings:

1. Recalling the teachings of Karl Popper, who taught the author’s generation to question all certainties, and of Daniel Federman, his mentor at Harvard who expected students to become insightful and questioning physicians. In effect, to be compassionate yet critical thinkers.
2. To understand the social consequences of disease and its impact on a patient’s daily life and employment.
3. The understanding that to be well is to be able to cope with morbidity.
4. To understand that the author is not against medical science, rather he favors a critically rigorous science.

As he writes, “The Last Well Person is a treatise on medicalization that is informed by science, clinical reality, and an analysis of life’s morbid experiences—even episodes of disease. . . .armed with skepticism and a critical intellect it is possible to benefit, safely and effectively from modern medicine without being harmed in the process.” p6

Chapter 1 is a critical analysis of what the author entitles “Interventional Cardiology and Kindred Illusions.” He points out how much less common heart attacks are today then a generation ago:

• My chance of having a heart attack at sixty is about 50 per cent less than my father’s chance when he
was my age.
• If my father had suffered his first heart attack when he was my age, his five-year potential for survival would have been about 50 per cent. If I have a heart attack, my likelihood of living another five years is at least 95 per cent—without any specific interventions.
• If I take a baby aspirin daily from the time of my first heart attack, the likelihood of surviving five years rises to better than 97 per cent. pp 7– 8

In effect he asks why “heart attacks and strokes . . . hold North Americans in thrall.” p18 p 8 Having reviewed a large number of the major studies he then goes on to challenge the conventional wisdom that coronary artery bypass surgery and angioplasty, except for the three per cent with left main coronary
artery disease, extend life, over medical therapy alone. He then sadly points out that, while the emperor has no clothes, this is a $100 billion annual business.

To abandon this theory would be to shut down interventional cardiology, nearly all of cardiovascular surgery, and many surgical supply houses and biotechnology firms. It would dramatically downsize most
hospitals and critical-care units in the United States and free up over $100 billion annually. Since 1987,
cardiovascular disease has been the largest source of health-care spending in the country and the costs keep escalating, with cardiologists and cardiovascular surgeons providing fodder for an enormous supporting industry.p27

This is an extraordinary challenge to the certainties of mainstream medicine. When I discussed this book with a cardiovascular surgeon, an old friend and university professor, he became indignant, but was unable to bring me a single paper in refutation of Dr. Hadler’s assertions. On the other hand, another cardiologist ruefully conceded that there was much truth in Hadler’s critique of the surgical treatment of heart disease.

Hadler continues with an evaluation of diet, lifestyle, and health. He argues that for most people economics determine diet and exercise and that community and economic class are crucial to lifestyle change. Always the iconoclast, he agrees that the cholesterol and low-density lipoprotein (LDL) lowering
statins can offer a modest benefit to those who have experienced a myocardial infarction and for those who have had a stroke, but where is the proof that statins can prevent cardiovascular events in the worried well? Interestingly, the October 3, 2006, issue of the Annals of Internal Medicine questions the target numbers for LDL cholesterol set by the National Cholesterol Education Panel. The plethora of benefits attributed to statins includes Alzheimer disease, rheumatoid arthritis, and possibly other autoimmune diseases. This sounds to my mind distressingly like a new panacea in the making.

The author continues with an analysis of colon screening for colorectal cancer. He concludes that:

I suspect that a defensible approach to screening that spares us the risk of dying from colorectal cancer before our time will remain a will-o’-the-wisp for some time to come.p76

In a quite thorough analysis of breast cancer treatment, the author again challenges the prevailing wisdom of the medical community. First reminding the reader that in the 1960s the famous surgeon Oliver Cope realized that radical mastectomy had not improved the survival of women with breast cancer, yet no medical journal would publish his observation. After reviewing the data on mammography in the diagnosis of breast cancer Hadler concludes:

If we take the most optimistic approach to these data as they relate to women in their forties, it is much ado about almost nothing of value. Much the same perspective applies to mammography in women fifty years of age or older.p9

His chapter on prostate cancer screening is brief, but again he questions the wisdom of screening and the psychological and physical harm that can result. Whether the American population can become educated rather than frightened remains to be seen. In his opinion, “PSA screening is disappointing at best and probably harmful.” p99

In Part Two, “Worried Sick,” the author hopes to prepare the healthy person for the promise of medicine.

The Last Well Person is the one who is able to confront clinical science without being medicalized and to
harness it for personal benefit. I have written this book to prepare the reader for this task.p 0

In subsequent chapters he examines “Musculoskeletal Predicaments,” “Medicalization of the ‘Worried Well,’" “Turning Aging into a Disease,” “Health Hazards in the Hateful Job,” and “Why Are Alternative and Complementary Therapies Thriving?” Each of these chapters is not only stimulating, but will be very helpful to patients.

In “Epilogue: A Ripe Old Age,” the author offers a summary of his thinking and then follows with an extended annotated bibliography which will be of great interest to physicians. He suggests that:

Standing up to the moral entrepreneurs and the health-care delivery system they have nurtured is a lonely and demanding task. It is painfully so for your physician, if she is so inclined, and very time
consuming. Common practices, algorithms (therapeutic roadmaps), guidelines, and reimbursement schemes all stand in the way of independent thinking. Your physician can arrange for a cardiac catheterization far more readily than he can manage the considerable time to discuss why it may not be necessary. There are many physicians, including my own students, who would gladly assume that latter role if the health-care delivery system made it feasible. If you find such a stalwart iconoclast in the current climate, you are fortunate.p204

This is a wonderful book that I have greatly enjoyed reading and rereading for this review. It has already formed the basis for a Grand Rounds in Internal Medicine, “On the Ethics of Prognosis,” that I and several of my gerontology and palliative care colleagues presented several months ago. In preparing that presentation, I returned to Alvin Feinstein’s 1967 book, Clinical Judgment, the book that arguably initiated the search for an evidence-based medicine. And that is precisely what Nortin Hadler argues for, that in the absence of solid evidence we should not hesitate, as physicians and patients, to trust our intuition and respect our critical faculties in our encounters with the health care system.

Dr. Bennahum is the book review editor of The Pharos, and a member of its editorial board. He is emeritus professor of Internal Medicine at the University of New Mexico School of Medicine. His address is:
707 Notre Dame Drive NE
Albuquerque, New Mexico 87 06
E-mail: [email protected]