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The "new ill": are you one of the 30%?

MagazineSeptember 2013 (Vol. 24 Issue 6)The "new ill": are you one of the 30%?

Up to a third of people are among the 'new ill'-people who, a generationbefore, would have been considered healthy, but are now categorized as ill andin need of medical care after being caught in today's tougher diagnosis traps

Up to a third of people are among the 'new ill'-people who, a generation before, would have been considered healthy, but are now categorized as ill and in need of medical care after being caught in today's tougher diagnosis traps.

If you're taking a prescription drug or perhaps about to go into hospital for surgery, there's a good chance you're among the 'new ill'. In fact, one-third of people who are today under medical care would have been considered healthy a generation ago. The proportion is even higher for some conditions like high cholesterol, prostate cancer, ADHD (attention-deficit/hyperactivity disorder) in children and adolescents, and asthma.

Many millions of people have been caught in the medical net as definitions of disease have become tougher. Quite literally overnight, 6.7 million American women suddenly had osteoporosis requiring medical treatment when the previous day they were borderline healthy.

This shifting of the goalposts happened when the US National Osteoporosis Foundation (NOF) set a new and tighter definition of the disease. Osteoporosis is determined by the T score, which measures bone density and is set at zero, based on a healthy, premenopausal woman. An older woman past the menopause is likely to have a negative T score, and the World Health Organization (WHO) arbitrarily set the T score for osteoporosis at minus 2.5. But the NOF shifted this to minus 2.0 in 2003, so creating a new market of six million women who suddenly required drug therapy.

The same thing happened a decade earlier when medicine tightened up its definition of cardiovascular disease and, in particular, blood pressure and cholesterol levels. In 1997 the 'danger' level for high blood pressure (hypertension) was changed from a reading of 100/160 mmHg to 90/140 mmHg, so suddenly making 13 million Americans candidates for antihypertensive drugs.

A further 42 million Americans overnight found themselves in line for a statin drug when the 'harmful' level of cholesterol in the blood was reduced from 240 mg/dL to 200 mg/dL or over. As most healthy people have a cholesterol level of around 200 mg/dL, this new definition casts the disease net very wide.

Also, mass screening programmes using increasingly sensitive technology are detecting cancers that will never endanger the patient and 'abnormalities' that are benign; conditions like this that will never develop into something that will seriously affect the patient or endanger life are called 'pseudodiseases'.1

Definitions of disease are driven by a desire to catch problems early-and

to find more customers for drugs. Many of the regulators who sit on the

boards that determine when disease begins have direct links with pharmaceutical companies that stand to benefit from a larger market for their drugs, says medical researcher Ray Moynihan, from Bond University in Queensland, Australia.2

Aggressive over-medicalization comes at a cost in both human and financial terms. It's reckoned that the United States alone is spending around $200 billion (lb128 billion) every year on unnecessary treatments. Yet the human cost is far higher. Many hundreds of thousands of people experience adverse reactions to antihypertensives, statins and other drugs, while overdiagnosis is also taking a heavy toll-from full mastectomies (complete removal of the breast) in women who don't even have cancer to life-destroying treatments for men who would have died with prostate cancer, not from it.

Are you among the 'new ill'?

Breast cancer.Up to 54 per cent of women who are diagnosed with breast cancer after a mammogram don't have the disease, but instead probably have DCIS (ductal carcinoma in situ), which develops into cancer in only around 10 per cent of cases. Nonetheless, surprisingly few oncologists recognize that DCIS is invariably benign and so they prescribe a range of aggressive treatments up to full breast removal.3

Thyroid cancer. The chances of getting a thyroid cancer diagnosis wrong are very high. Sensitive screening technology often detects an abnormality in the thyroid that will never turn into cancer. Even genuine cancers detected in the thyroid are often small, non-aggressive and unlikely to harm the patient, yet detection invariably triggers therapies that can permanently damage the nerves and require life-long medication.4

Gestational diabetes. Around 18 per cent of pregnant women suddenly found themselves in need of urgent medical treatment after the criterion for gestational diabetes (hyperglycaemia due to pregnancy) was altered in 2010, thus doubling the number of 'sick' people. Advocates for the more rigorous definition have argued that it reduces health problems at birth, including babies that are 'large for gestational age'.5

Chronic kidney disease. Around a third of the over-65s are deemed to have chronic kidney disease yet fewer than one in 1,000 of these cases progresses to life-threatening end-stage renal disease each year. The definition of the disease was altered in 2002 (as measured by estimated glomerular filtration rate, or eGFR), a move that has been described as "a fishing trawler that captures many more innocent subjects than it should".6 One problem is the eGFR test itself, known to be inaccurate. Despite this, elderly people are being diagnosed with disease based on a single measurement, and "the majority of those held to have chronic kidney disease have no identifiable kidney disease".7

Asthma. This is a chronic-and sometimes life-threatening-respiratory disorder and yet, despite its obvious symptoms, more than 30 per cent of patients were diagnosed when they didn't have the problem, while around 66 per cent of those who were correctly diagnosed didn't need the drugs six months later.8

Pulmonary embolism. A blood clot causing sudden blockage of the main artery of the lung can be fatal, and doctors used to detect it only when there was tissue death (infarction) in the lungs. Today, doctors have the benefit of computed tomography pulmonary angiography (CTPA), which can detect even the smallest clots. As a result, the incidence of pulmonary embolism has apparently doubled, leading to "an epidemic of diagnostic testing that has created overdiagnosis", say the authors of one review, especially of clinically unimportant cases that are not life-threatening.9 While a pulmonary embolism is frightening, doctors are so vigilant that they order a CTPA scan at the slightest suspicion; for this reason, the authors all for a degree of common sense.

ADHD.This condition has become almost a matter of fashion rather than a genuine diagnosis, and children's bad behaviour and naughtiness of previous generations have now become a disease to be treated with powerful drugs. To illustrate the point, researchers analyzed the case reports of around one million children in Canada who had been so diagnosed. Those whose birthdays were in December-and so were among the youngest in their school year-were, on average, 50 per cent more likely to be diagnosed with ADHD than their January-born classmates.10

Seeing more problems

A change in the definition of what we call disease is certainly one driver of the epidemic of overdiagnosis, but by far the biggest is the sophisticated screening technology that allows doctors to see an abnormality even before it escalates into disease.

But the new technology is also discovering something else that's rather interesting: most of us have some 'abnormality' that will never develop into a medically recognized disease. This phenomenon, referred to as a 'reservoir of abnormalities', has been highlighted by researchers who screened healthy individuals who had no symptoms, but nevertheless found that:

o around 10 per cent of us have gallstones, as detected by ultrasound, and yet have never displayed any symptoms such as pain, nausea or problems with fatty foods11

o about 40 per cent of us have knee damage, as detected by magnetic resonance imaging (MRI) scans, yet have no knee pain or even a history of knee injury12

omore than 50 per cent of us have bulging lumbar discs, according to MRI scans, but have never experienced any back pain.13

These figures are averages and may differ according to age and gender. For example, only 2 per cent of men under age 40 have gallstones detected by ultrasound when they have no symptoms compared with 9 per cent of women in the same age group, whereas 80 per cent of both men and women over the age of 50 have bulging discs with no symptoms.4

Another problem is the reliability of findings. Not only is screening technology often picking up symptomless abnormalities, but it can also 'see' problems that aren't even there. Mammography, designed to detect early-stage breast cancer, produces 10 'false-positive results'-cancers that aren't there-for every genuine case it detects.14 In fact, the rise in breast cancer cases over the past 20 years is almost entirely due to overdiagnosis, or false positives, say researchers from the Norwegian Institute of Public Health.

Comparing annual cancer rates for the years 1991 to 2009, new diagnosis numbers remained stable in the 40- to 49-year-old age group, but rocketed by 50 per cent in the 50- to 69-year-olds immediately after routine mass mammography screening was introduced.15

The silent majority

Most of us are walking around with medical problems that will never give us any problems. Some 10 per cent of us have gallstones with no problems, 40 per cent of us have knee damage with no pain and 50 per cent of us have bulging spinal discs, but no symptoms.

10% have gallstones

40% knee damage

50%+ bulging lumbar discs


Overtreatment

If you do have symptoms and a problem is confirmed by a scan, the next level of medicalization then comes into play-overtreatment.

However, symptoms and a confirmatory test still don't necessarily point to the correct cause: a patient complaining of knee pain-and with a scan that shows damaged cartilage-is in the fast-track queue for arthroscopic knee surgery. But scans pick up many abnormalities, and it's possible that the damaged cartilage isn't the problem and that the pain is instead caused by arthritis. If that's the case, then knee arthroscopy may well do more harm than good.16

The greatest examples of overtreatment are seen when 'cancer' is detected, a finding that inevitably sends medicine into overdrive. For prostate cancer, surgery and radiation are the two main assaults-as they are for most cancers. Surgery in this case-called 'radical prostatectomy', or complete removal of the prostate and its surrounding tissue-causes life-long sexual dysfunction in half of all patients, and 30 per cent have problems urinating.

Radiation produces the same side-effects but, in addition, can also damage the rectum: 15 per cent of men treated with radiation develop "a moderate or big problem" with defecation, usually in the form of pain

or urgency.17

Women diagnosed with breast cancer face similar life-debilitating courses of action, including chemotherapy, radiotherapy and/or breast surgery. The side-effects of chemotherapy drugs include mucositis (inflammation of the mucous membranes), heart and bile-duct problems, bone-tissue death, infertility, and reduced numbers of white and red blood cells.

Many of these cases were misdiagnoses of breast cancer or, in the case of prostate cancer, were not

killers. Histopathologists have discovered the presence of prostate cancer in as much as 75 per cent of men aged over 85 years who were examined on autopsy, suggesting that most men develop the cancer, but few die because of it.18

Given such overdiagnosis and overtreatment, you would at least expect the death rate from cancer to have fallen-but it has hardly altered in the past 30 years. Around 24 men per 100,000 die because of prostate cancer every year in the US and have done so since 1975, but over the same period, diagnoses have increased from around 90 per 100,000 in 1975 to 150 per 100,000 in 2005, peaking in 1993 with 227 new cases per 100,000 men.19

A similar picture can be seen for breast cancer. Despite the increase in diagnoses-and subsequent treatments-the number of women dying from the disease has remained the same for 30 years. In 1975, 27 women per 100,000 died of the cancer; during 2006-2010, the figure was 23 per 100,000 in the US. Over the same time period, new diagnoses increased by up to 75 per cent, from 100 new diagnoses per 100,000 women in 1975 to 175 per 100,000 in 2001, falling away slightly to 155 per 100,000 by 2005.20

No lifesaver

Although modern mammography has vastly increased breast-cancer diagnoses (by a whopping 50 per cent) in the last 30 years or so, all that getting-in-there-early treatment hasn't translated into any appreciable lives saved. Around the same number of women (27 per 100,000) die every year now as did in 1975.

1975

27 Deaths per 100,000

2006-2010

23 Deaths per 100,000

1975

100 Diagnoses per 100,000

2005

155 Diagnoses per 100,000


Body, heal thyself

Overtreatment is a manifestation of a medical system that sees itself as the guardian against all that ails us, but one that does not recognize the extraordinary healing powers the body itself possesses.

Stroke, for example, is a debilitating and sometimes fatal disease-and one that has the doctor pushing the panic button. But despite this common perception, many of us have suffered a stroke and never noticed.

One study of around 2,000 healthy people discovered that 10 per cent had suffered a stroke, usually a 'silent stroke'. It also happens to younger people too: an MRI scan revealed that 7 per cent of the under-50s had a stroke at some point and yet the brain was able to repair the damage on its own.21

Astonishingly, cancer is another feared disease that doesn't always follow an inevitably aggressive pattern. Breast cancer, for example, seems to have a six-year cycle, at the end of which it appears to regress. Researchers made the discovery when they analyzed the progress of the cancer in Norwegian women who were regularly screened, and compared them with those who were screened only at the beginning and end of the same six years. Although the cumulative rate of cancer was higher in the screened group-which was as expected-those who had cancer detected at the beginning of the six-year period had no trace of the disease when they were screened at the end of the trial.22


Introducing incidentalomas

Radiologists-the specialists who operate and interpret screening technologies like X-rays, CT and MRI scans-often detect nodules on the liver, lungs and kidneys that may be cancerous-but, then again, they may not be.

They call these growths 'incidentalomas' (incidental as in minor or trivial, and 'omas', meaning tumours or growths). Half of smokers who are screened have lung incidentalomas compared with just 15 per cent of non-smokers, while 67 per cent of people having an ultrasound show incidentaloma activity in the thyroid.

Judging by the name they've been given, you would think that radiologists would dismiss the findings-but their professional bodies are urging them not to.1

So what's a radiologist to do? If he follows his gut hunch, he keeps the finding to himself, doesn't worry the patient unnecessarily and doesn't trigger a series of further tests or even treatments that are not required. But if he does this and the growth becomes cancerous, he faces lawsuits and even an enquiry.

Such are the driving forces of medicalization.

References

1. Applied Radiology Digital; http://www.appliedradiology.com/Issues/2013/02/Articles/How-do-you-solve-a-problem-like-incidentalomas-.aspx

Think again

Medicalization-the harming of the healthy-is becoming a hot topic in medicine, with politicians and health regulators starting to join in.

In 2010, the prestigious peer-reviewed medical journal Archives of Internal Medicine launched a 'Less is More' campaign, where doctors were invited to nominate treatments and routine screenings that might be doing more harm than good.

Last year, nine physician groups and organizations joined forces to launch the 'Choosing Wisely' initiative. As a group, these various specialties listed 40 procedures or tests that they believe are unnecessary (see bellow).

Medicine's own governing bodies are beginning to relax their definitions of illness, and the first could be a lowering of the thresholds considered high blood pressure. If the proposals go through, 100 million people will suddenly be 'well' and will no longer need to take antihypertensive drugs.

In general, overdiagnosis may be the result of a desire to do what's best and to beat disease before it takes hold. But in doing so, medicine has caused enormous damage-and perhaps is finally waking up to the harm it has been doing to the healthy.


40 procedures you probably don't need

Nine physician groups representing different specialties got together to form Choosing Wisely (www.choosingwisely.org), an initiative aiming to reduce unnecessary procedures and tests. Here are some of their main recommendations.

Allergy, asthma and immunology

1. Don't allow unproven diagnostic tests-like IgG and IgE blood tests-to establish an allergy.

2. Don't have sinus CT (computed tomography) scans for uncomplicated viral infections like rhinosinusitis.

3. Don't have a routine test if you have chronic urticaria (hives).

4. Don't have replacement immunoglobulin therapy for recurrent infections.

5. Don't accept a diagnosis of asthma unless you've
had a spirometry test.

Family health

6. Don't have imaging screening during the first six weeks of back pain.

7. Don't regularly take antibiotics for mild sinusitis (a runny nose).

8. Say 'no' to dual-energy X-rays for osteoporosis screening if you're female and under age 65, or male and less than 70 years of age.

9. Don't have routine annual screening for cardiac problems if you have no symptoms.

10. Don't have a Pap smear if you're under 21 or you've had a hysterectomy for a non-cancerous problem.

Heart health

11. Don't have stress cardiac imaging as your initial and exploratory testing if you don't have any symptoms of a heart problem.

12. Don't have annual stress cardiac imaging as part of routine follow-ups.

13. Don't have stress cardiac imaging as a preoperative assessment if you're scheduled for low-risk, non-heart surgery.

14. Don't have an echocardiogram as a routine follow-up for mild valvular disease.

15. Don't have stents inserted into arteries for stable angina (chest pain).

General health

16. Don't have exercise electrocardiography (ECG) if you have no symptoms of heart disease and you're at low risk.

17. Don't have imaging screening for low back pain.

18. Don't have an MRI (magnetic resonance imaging) scan as a routine neurological examination.

19. Don't have imaging screening as the initial diagnostic test if venous thromboembolism is suspected.

20. Don't have chest radiography if you have no signs of a heart problem.

Screening

21. Don't have imaging for uncomplicated headaches.

22. Don't have imaging as a first-line examination for suspected pulmonary embolism.

23. Avoid a chest X-ray as part of your routine diagnostics before going into hospital.

24. Don't use CT screening on a child if appendicitis is suspected; use ultrasound first.

25. Don't have follow-up imaging for cysts.

Gastric health

26. If you have reflux problems, use long-term acid suppression therapy only at the lowest possible dose.

27. Don't repeat colorectal cancer screening more than once every 10 years.

28. Don't repeat a colonoscopy for at least five years if you have only one or two small polyps.

29. If you suffer from Barrett's oesophagus, don't have a second endoscopy within three years.

30. Don't have a CT scan for abdominal pain.

Cancer health

31. If you have solid tumours, don't accept therapies that have no track record of success.

32. Don't have PET (positron emission tomography) or CT scans if you're in the early phases of prostate cancer.

33. Don't have a PET or CT scan if you're in the early stages of breast cancer.

34. Don't have tests or imaging if you have no symptoms of breast cancer.

35. Say 'no' to white-cell stimulating factors if you have less than a 20 per cent risk of febrile neutropenia (abnormally low white cell counts) as a complication.

Kidney health

36. Don't have routine cancer screening if you're on dialysis.

37. If you have chronic kidney disease and a haemoglobin level over 10 g/dL without anaemia, don't use ESAs (erythropoiesis-stimulating agents).

38. Avoid all NSAIDs (non-steroidal anti-inflammatory drugs) if you have heart disease, heart failure or chronic kidney disease, or diabetes.

39. If you have acute kidney failure, don't have central catheters inserted without first getting the permission of your kidney specialist.

40. Don't have chronic dialysis without the agreement of your family and the physicians involved.

Bryan Hubbard

References

1. Arch Intern Med, 2011; 171: 1268-9

2. BMJ, 2012; 344: e3502

3. Lancet Oncol, 2007; 8: 1129-38

4. Welch HG, et al. Overdiagnosed: Making People Sick in the Pursuit of Health. Boston, MA: Beacon Press, 2011

5. Diabetes Care, 2010; 33: 676-82

6. Nephron Clin Pract, 2011; 119 Suppl 1: c2-4

7. Nefrologia, 2010; 30: 493-500

8. CMAJ, 2008; 179: 1121-31

9. Arch Intern Med, 2011; 171: 831-7

10. CMAJ, 2012; 184: 755-62

11. Invest Radiol, 1991; 26: 939-45

12. Radiology, 1990; 177: 463-5

13. N Engl J Med, 1994; 331: 69-73

14. Pol Arch Med Wewn, 2010; 120: 89-94

15. Tidsskr Nor Laegeforen, 2012; 132: 414-7

16. N Engl J Med, 2008; 359: 1097-107

17. J Natl Cancer Inst, 2000; 92: 1582-92; N Engl J Med, 2008; 358: 1250-61

18. Lancet, 2003; 361: 859-64

19. http://www.cancer.gov/cancertopics/factsheet/cancer-advances-in-focus/prostate; http://seer.cancer.gov/csr/1975_2008/results_merged/sect_23_prostate.pdf

20. http://seer.cancer.gov/statfacts/html/breast.html;

?? http://seer.cancer.gov/csr/1975_2009_pops09/results_merged/sect_04_breast.pdf

21. Stroke, 2008; 39: 2929-35

22. Arch Intern Med, 2008; 168: 2311-6




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