Winding back the harms of too much medicine
BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1271 (Published 26 February 2013) Cite this as: BMJ 2013;346:f1271
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A medical intervention for children, being conducted in Fukushima, Japan, deserves to be discussed in this “Too much medicine” campaign.(1)
Since October 2011, Fukushima prefecture has been conducting a thyroid ultrasound examination program for residents aged <=18 years. As of June 30, 2014, 296026 children have been tested (screening rate, 80.5%), of whom 104 were either found to have or suspected to have thyroid malignancy.(2) While the absence of a control group makes it difficult to interpret this result,(3) forming a large-scale control group can raise ethical concerns, given the possibility of over-diagnosis and over-treatment. Here, as a historical control we estimated the prevalence of juvenile thyroid cancer in Fukushima prefecture before the start of the thyroid examination program, using population-based statistical data.
The estimation targeted the prevalence of thyroid cancer in prefectural residents aged <=40 years in 2010 (a year before the Fukushima Daiichi nuclear disaster). By using the life table method based on thyroid cancer incidence and overall mortality rates, we calculated the age-specific cumulative probability of thyroid cancer incidence,(4,5) and multiplied it by the number of residents aged 0 in each calendar year. Summing the age-specific prevalence for each birth cohort to a given attained age produced the age-specific cumulative prevalence.
Figure shows that, in 2010, the prevalence of thyroid cancer in children aged <=18 years in Fukushima was estimated to be 2.1 persons (0.5 male and 1.6 females). The age in which the prevalence of thyroid cancer exceeds 50 persons in both sexes combined was estimated to be 31 years and that exceeding 100 persons was estimated to be 35 years. By using the same method, the cumulative probability of thyroid cancer mortality in persons aged 40 years is one in approximately 300,000 persons (0.00027% in males and 0.00032% in females).
Compared with these results, the fact that as many as approximately 100 thyroid cancer cases aged <=18 years have currently been found suggests over-diagnosis. As of 2013, the age-standardized mortality rate of thyroid cancer in Japan has been decreasing for both males and females. In South Korea, widespread adoption of thyroid cancer screening in adults led to a rapid increase in the incidence of thyroid cancer, but the mortality rate remained unchanged.(6) Surgery for thyroid cancer requires most patients to take lifelong medications and can cause complications in a few cases. A false-positive result leads to unnecessary, sometimes invasive, additional procedures. In fact, in the thyroid examination program in Fukushima, 2237 children (0.8%) proceeded to the additional examination, of which 485 underwent aspiration biopsy. A balance between the potential risks and benefits must be considered for the implementation of the thyroid examination program.
References
1. Moynihan R, Glasziou P, Woloshin S, Schwartz L, Santa J, Godlee F. Winding back the harms of too much medicine. Bmj 2013;346:f1271
2. Tentative Summary Results of the Fukushima Health Management Survey (Thyroid Ultrasound Examination Programme) 2014. (http://www.pref.fukushima.lg.jp/sec/21045b/kenkocyosa-kentoiinkai-15.html) [in Japanese]
3. Shibuya K, Gilmour S, Oshima A. Time to reconsider thyroid cancer screening in Fukushima. Lancet 2014;383:1883-4
4. Kamo K, Katanoda K, Matsuda T, Marugame T, Ajiki W, Sobue T. Lifetime and age-conditional probabilities of developing or dying of cancer in Japan. Japanese journal of clinical oncology 2008;38:571-6
5. Wun LM, Merrill RM, Feuer EJ. Estimating lifetime and age-conditional probabilities of developing cancer. Lifetime data analysis 1998;4:169-86
6. Ahn HS, Kim HJ, Welch HG. Korea's thyroid-cancer "epidemic"--screening and overdiagnosis. The New England journal of medicine 2014;371:1765-7
Competing interests: S. Tsugane is a member of the review committee of the health examination program in Fukushima prefecture, Japan.
In today's internet age, particularly, patients also want more investigations and more fanciful diagnoses. Sicknesses are highly haloed in developing countries. Doctors are also becoming highly 'intellectual'. The old wisdom of " I dressed the wound and God healed it " seems desirable. But will it be followed?
Competing interests: No competing interests
Too much medicine is also too much marketing, with too little science and no conscience at all.
Linagliptin (Trajenta), a new drug "for type 2 diabetes" as it is being promoted to doctors like me in the Philippines (yes, that is a real chicken egg in the box). This comes with an invitation to a "round table discussion" with the "diabetes experts" in an expensive, fancy restaurant. Clearly too much medicine here.
Competing interests: No competing interests
The treatment of type 2 diabetes is a subject deserving full attention by the "Too much medicine" campaign? (1)
The commercialisation of type 2 diabetes (T2DM) is hampering efforts for international prevention and is leading to overtreatment and under-education for both medical and self-management of this disorder.
The rapid increase of type 2 diabetes is of global concern. In the United Kingdom the difficulties of type 2 management in England were recently highlighted by diabetes consultants in the BMJ. (2) http://www.bmj.com/content/345/bmj.e5446
Concerns have also been expressed over the role of the Quality of Outcomes Framework in tight glucose control and the risk for hypoglycaemia in patients. (3)(4)(5) Study findings imply that intensive HbA1c lowering therapy increases mortality risk across the age continuum (6) Hypoglycaemia is a recognized hazard of intensive therapy, being more frequent in intensively treated patients. (7) Yet the quest for tight glucose control continues despite lack of evidence of its efficacy.
The Quality of Outcomes Framework appears to undermine the skill, expertise and discretion of doctors in treating type 2 diabetes. Has this system created an unnecessary burden to the medical profession but failed diabetic (T2DM) patients?
When Deborah Cohen and Professor Gale questioned the safety and efficacy of the incretin mimetic group of diabetes drugs their concerns were met with much criticism and controversy. (8)(9) Why would this be, surely everyone would wish to ensure patient safety and to secure the best available advice and treatment for their patients?
Eminent diabetologist Professor Gale stated ‘There has been a clear trend toward earlier and more aggressive intervention, which has translated into lower diagnostic thresholds and the reintroduction of the concept of prediabetes.’(10)
Have the concerns of diabetes specialists and many health professionals been overlooked in favour of .the food and drug industry which has an unduly high influence within diabetes?. Whilst diabetes medications are important components in diabetes management for some, many people believe that contact with drug representatives and industry sponsored education are forms of marketing, and studies have shown that they lead doctors to prescribe drugs that may not be in patients’ best interests. (11)
There is a worrying trend of charities receiving large grants from the food and drug industry, with charities even taking on partnerships with industries whose activities have contributed towards the progression of obesity and the development of diseases such as type 2 diabetes and cardiovascular disease. This portrays the industry in an altruistic light, as they are seen to be involved in disease prevention when their wide ranging products certainly suggest otherwise. As part of their charity work they can also market their food and drug solutions to problems which are essentially lifestyle instigated. Functional foods are not currently recommended as part of disease management yet they are suggested as solutions. Such conflicts of interest are not in the interest of people relying on unbiased and affordable solutions to world health problems, many of which are preventable. The food and drug industry indeed seem to have more power and influence than any world government or world health organisation.
Professor Lehman, who has a rare gift for highlighting the key issues in medicine, recently wrote in his regular BMJ blog:.
If, in retirement, my enjoyment of food causes me to get fatter and develop “type 2 diabetes,” I really won’t care very much. But if I were a Bangladeshi woman aged 40 with a BMI of 38 and diabetic neuropathy, expected to stay at home and look after five children and a couple of elderly relatives, I might take a quite different view. It is long term quality of life which counts. Quantity of life is also a factor. (12)
Type 2 diabetes was formerly a disease affecting a selective population mainly over the age of sixty and for most was treated with dietary management.
Recent solutions for T2DM suggest that harmful drugs and bariatric surgery provide world wide solutions to the T2DM epidemic. (13)(14) A 2013 randomised trial has confirmed that bariatric surgery can improve glycaemic control for adults with type 2 diabetes and moderate obesity. (15)
Diabetes (T2DM) management is proving difficult in countries which have good access to medical care. Of great concern is the emergence of T2DM diagnosis in children and in pregnancy.
The tragedy of the situation is that T2DM affects people from low income countries where access to even basic medical care, sustainable food supplies, and educational resources can be impossible. Further to this dire situation, drug companies often use such populations to trial their new drugs.
Where is the prevention of type 2 diabetes without drugs? Expensive diabetes medications or bariatric surgery are not viable options to those living in low income countries.
The T2DM epidemic has followed the mass change of diet from indigenous foods, to the consumption of a diet of highly processed foods which are high in carbohydrates and fats, but low in nutrition. Yet carbohydrate management is notably absent from new diabetes studies.
The issues within the world wide epidemic of diabetes (T2DM) are many and complicated, but need closer attention outside commercial enterprise.
The overtreatment of T2DM with drugs and ill thought out dietary management has meant under education of managing healthy diet and lifestyle with T2DM.
(1) Winding back the harms of too much medicine BMJ 2013;346:f1271
(2) Kilvert A Rayman D The crisis in diabetes care in England BMJ 2012;345:e5446
(3) Lehman R, Krumholz HM. Tight control of blood glucose in long standing type 2 diabetes. BMJ 2009;338:b800.
(4) Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59
(5). Currie CJ, Peters JR, Tynan A et al Survival as a function of HbA1c in people with type 2 diabetes: a retrospective cohort study. Lancet 2010;375;481-489
(6) Nicholas J, Charlton J, Dregan A, Gulliford MC (2013) Recent HbA1c Values and Mortality Risk in Type 2 Diabetes. Population-Based Case-Control Study. PLoS ONE 8(7): e68008. doi:10.1371/journal.pone.0068008
(7) Kowall B, Rathmann W, Heier M, Giani G, Peters A, et al. (2011) Categories of glucose tolerance and continuous glycemic measures and mortality. Eur J Epidemiol 26: 637–645. doi: 10.1007/s10654-011-9609-y.
(8) Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? Deborah Cohen. BMJ 2013;346:f3680.
(9) Rapid Responses to Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? Deborah Cohen. http://www.bmj.com/content/346/bmj.f3680?tab=responses
(10)Gale, E.A.M.. Historical aspects of type 2 diabetes [internet]. 2013 [cited 2013 Aug 13]; Diapedia 3104287134 rev. no. 28. Available from: http://www.diapedia.org/type-2-diabetes-mellitus/3104287134/historical-a...
(11) Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, et al. Information from pharmaceutical companies and the quality, quantity and cost of physicians’ prescribing: a systematic review. PLoS Med 2010;7:e1000352. CrossRefMedline
(12) http://blogs.bmj.com/bmj/2013/06/10/richard-lehmans-journal-review-10-ju...
(13)The advent of bariatric surgery for diabetes in India Ron Thomas Varghese
Cite this as: BMJ 2013;347:f3391
(14). Roux-en-Y Gastric Bypass vs Intensive Medical Management for the Control of Type 2 Diabetes, Hypertension, and Hyperlipidemia
(15) The Diabetes Surgery Study Randomized Clinical Trial.
Sayeed Ikramuddin, MD; Judith Korner, MD, PhD; Wei-Jei Lee, MD, PhD; John E. Connett, PhD; William B. Inabnet, MD; Charles J. Billington, MD; Avis J. Thomas, MS; Daniel B. Leslie, MD; Keong Chong, MD; Robert W. Jeffery, PhD; Leaque Ahmed, MD; Adrian Vella, MD; Lee-Ming Chuang, MD, PhD; Marc Bessler, MD; Michael G. Sarr, MD; James M. Swain, MD; Patricia Laqua, RD; Michael D. Jensen, MD; John P. Bantle, MD. JAMA. 2013;309(21):2240-2249. doi:10.1001/jama.2013.5835.
Competing interests: No competing interests
I warmly welcome this article on the harms of over investigation and over diagnosis.
I recently had the opportunity to take part a work exchange in North Carolina, USA, where I shadowed ED doctors and GPs. The over investigation I observed was shocking, from chest x rays organised for young people with a few days of cough, with no auscultation of the chest, to MRI with contrast of the brain for a young patient with alcoholism with subjective tingling in one hand for several weeks, again with minimal examination.
The causes of this over investigation are complex, with one of the main drivers being the fear of litigation from missed diagnoses, as well as perverse financial incentives for the physician who gets paid more for investigating more. In addition, there is an expectation from patients that every symptom needs to be investigated from many TV campaigns from pharmaceutical companies.
This culture of defensive investigation has led to mistrust from patients as to whether they really need an investigation, knowing of the physician's financial incentives, and a lowering of job satisfaction in physicians who feel that they are no longer allowed to trust their clinical skills or the basic principle of only doing a test if it will change the management of the patient.
I have seen this culture creep into practice in the UK, with many more low risk headaches being investigated with CT and the default position seeming to be tilting ever more towards investigating, 'just in case' rather than watching and waiting.
In the US it is the individual who bears the financial burden of these unnecessary investigations, either from their own pocket if uninsured, or through insurance premiums. In the UK, it is the NHS that bears the financial cost, and risks a huge financial burden from the growing culture of over investigation, as well as the psychological and possible physical harm to the patient.
I observe with interest that the conference on 'Too Much Medicine' will be taking part in the US where this culture seems to have reached crisis point. I also feel that we need to be honest with the public in the UK about the fact that many times it is best not to investigate. However, we need back up and support from the government, media and medical defense bodies. We need an open debate with the public about 'patient choice' and the fact that when they consult a doctor for a professional opinion they will, after discussion with the patient, receive the tests and treatment that they clinically need, not what they feel they want, a growing challenge in our individualist culture where people are armed with facts from the internet and with the feeling of entitlement that they have been promised with the government's mantra of 'patient choice'.
Increasingly it takes a brave clinician not to test, against this culture of investigation, but I do feel that often to test by default, rather than have a discussion with the patient about the pros and cons of testing, is lazy medicine. I welcome the BMJ's campaign on the issue.
Competing interests: No competing interests
Would Type 2 Diabetes screening and management be discussed in the "Too much medicine" campaign?
I have read the NHS/NICE National Clinical Guideline for Type 2 Diabetes, particularly the part where "glucose control levels" were discussed. I am interested to know how NICE has made its computations for Cost per QALY of "treating to target HBa1c" so that for Type 2 Diabetes management "targeting HBa1c" as a management approach has been recommended. I found out that the associations with the different Hba1c levels to Diabetes complications found in UKPDS no. 35 (an observational study) and a meta-analysis of observational studies on the same was used to estimate and extrapolate treatment benefits of lowering HBa1c. I find it quite disturbing that a claim to beneficial effects of a treatment (especially with regards to mortality and cardiovascular outcomes) was made based on observational studies.
Treating to target HBa1c is no small matter: the impacts of the costs of monitoring and treatment, frequent blood sugar tests, HBa1c tests, hypoglycemia episodes and more importantly the effects on "patient" psychological well-being are tremendous. Therefore evidence to support such practice should have been more stringent and more solid in my opinion.
I hope the "Too much medicine" campaign would look closer at Type 2 Diabetes and its screening and management. The profitability of Type 2 Diabetes to industry, the progressively lower threshold to diagnosis with lower blood sugar levels, proliferation and early adoption of numerous Diabetes drugs that causes more definite harm than good, and the consistent failure of recent randomized controlled trials to support the current practice of "treating to target": these are to me clear signs of too much medicine.
Competing interests: No competing interests
Thank you so much for the article on over diagnosis and treatment. It is very timely and means a lot to the physicians and patients. I would like an article on the over diagnosis issues following PET CT done for malignancies, especially on the thyroid uptake.
Competing interests: No competing interests
The waste and potential harm of untested ISO accreditation needs to be considered as well as an excess of medicines.
Pathology laboratories have been purchasing accreditation to ISO 15189 and ISO 17025 standards from CPA and UKAS for years. More recently, its growth has spread into radiology and physiological measurement. “Quality” has been redefined strangely as compliance with these standards. Yet, as a consumer, no-one assesses the quality of any other product or service as compliance with ISO standards.
Do obsessively precise measurements and the collection of exhaustive records to enable inspection really improve patient care or is accreditation just an employment scheme for inspectors whose role is outdated? The value of ISO standards for products has not been clearly shown to extend to their systems of management inspection. The Advertising Standards Authority found against the BSI for its wishful claim that BS 5750 paid for itself in cost savings. In the USA, largely without ISO accreditation, labs fail to detect 1 in 20 pathogens. http://bit.ly/1b3tWxT External Quality Assurance figures for the UK have not been published and may be little different despite widespread accreditation.
ISO accreditation ought to viewed with the same suspicion as other medical interventions. Like other management fads it is likely to be wasteful and counterproductive. Accreditation is expensive and distracts from job purpose. Its efficacy, effectiveness and value have not been proven according to Cochrane's principles. Accreditation has been designed to make verification very difficult but whether it is ethical to use it without rigorous testing is questionable.
If accreditation has the power to benefit patients it may also have the power to harm – probably through waste of financial and human resources and delivering a confidence that is false. The cartel of ISO inspection organisations needs to be subjected to validation from outside its membership and equivalent to that for pharmaceutical interventions.
ian.wilson1ATbelfasttrust.hscni.net
Competing interests: My duties encompass the role of quality manager.
I am in entire agreement that conservative medicine is good medicine and that less is often better than more. However, Numbers Needed to Treat remain a very misleading way to understand the effects of medicine. There are many articles explaining why but a particularly disturbing (to any NNT devotee) analysis was provided in 2011 by Snappin and Jiang(1)
Reference
1. Snapinn S, Jiang Q. On the clinical meaningfulness of a treatment's effect on a time-to-event variable. Statistics in Medicine 2011; 30: 2341-2348.
http://www.ncbi.nlm.nih.gov/pubmed/21520457
Competing interests: I consult for the pharmaceutical industry and maintain a full declaration of interest here http://www.senns.demon.co.uk/Declaration_Interest.htm
Re: Winding back the harms of too much medicine
The Radio4 announcement this morning caught my attention; following articles in the Times and BMJ that the Academy of Medical Royal Colleges think that not all Doctor's recommendations are necessary, and that patients should check, but people have far too much respect for doctors.
Doctors aren't taught the alternatives to prescribing - so how will they ever recommend anything else?
And even then they can only prescribe from 'the list', thanks to licensing laws.
No-one has begun to think of the implications regarding TTIP, if our health provision becomes profit based - how will we ever trust a doctor's recommendation if someone else can make money out of it?
Especially if even the Academy of Medical Royal Colleges already thinks there is a problem there.
The British Gut Project is just the start of something really incredible, the medical profession might finally catch on to the true causes of ill health, and how the medical approach today just compounds the problems.
As a strong advocate (from personal experience) for diet as treatment for health, I find that doctors really don't know or learn enough despite our unfailing respect for them.
Even when researchers find diseases linked to the absence of certain bacteria - the first thought is to manufacture a tablet to replace it, but what if the problem in the first place is that the gut environment was hostile? It really is ALL about what you eat.
So what if the best course of action really is none at all? But the health provision has to turn a profit? What will they sell you? Or bill the NHS for?
The implications of what I am trying to say would make a VAST difference to NHS spending and my ultimate hope is that people I love will stop having to suffer, because they refuse to question, or look beyond the advice of their doctor.
Competing interests: No competing interests