Revising guidelines for testosterone testing could more accurately diagnose deficiency

One of the issues under discussion among patients and doctors in Singapore is how to determine when there is a need to treat men with supplemental testosterone therapy.  This new study shows that levels of free testosterone are more informative than total testosterone levels

European Society of Endocrinology     16 May 2015

A new study presented at the European Congress of Endocrinology in Dublin suggests that some men suffering from testosterone deficiency may be missed under current clinical guidelines while others are misdiagnosed with testosterone deficiency. The researchers call for a revision of the clinical guidelines to ensure that men are receiving the best possible care.

Testosterone deficiency, also known as male hypogonadism, can lead to decreased libido and infertility, but it has also been associated with a higher risk of developing metabolic syndrome, diabetes and osteoporosis. In men, testosterone levels gradually decline with age. In recent years, an increasing number of ageing men are presenting with symptoms suggestive of hypogonadism and testosterone levels that are around or below the lower limit for young men. To date, the diagnosis of hypogonadism in these middle-aged and elderly men and their management remains controversial.

Researchers at the University of Manchester, UK and the University of Leuven, Belgium (represented by Dr Leen Antonio) used data from the European Male Aging Study (EMAS) to determine the relative importance of total and free testosterone measurements in diagnosing testosterone deficiency in aging men.

Testosterone exists in the body in two states; bound to proteins (98 % of total testosterone) and non-protein bound or free (2% of total testosterone), the latter being the biologically active fraction. Current clinical guidelines suggest that testosterone deficiency is diagnosed by measuring total testosterone levels. However Dr Antonio’s study shows that levels of free testosterone are more informative.

Only free testosterone can enter cells and is responsible for testosterone action. When men get older, total testosterone levels decrease while the levels of the protein that binds it increases. This means that the level of free testosterone decreases more than the total testosterone with age.

Dr Antonio, “We show that middle-aged and elderly men with normal total testosterone levels but low free testosterone levels have more symptoms of hypogonadism compared to normal men than those with normal free but low total testosterone – these men currently miss out on treatment because they are not diagnosed with testosterone deficiency.”

“On the other hand, men with low total testosterone but normal levels of free testosterone do not suffer from testosterone deficiency, yet are misdiagnosed with the condition and can be treated with testosterone inappropriately.”

Dr Antonio and colleagues propose that new guidelines should recommend measuring free testosterone, in addition to total testosterone, in the evaluation of men with hypogonadal symptoms.

http://www.alphagalileo.org/ViewItem.aspx?ItemId=152794&CultureCode=en

 

Real evidence based medicine

Trish Greenhalgh and Neal Maskrey

Trish Greenhalg is Professor of Primary Care Health Sciences and Fellow of Green Templeton College at the University of Oxford. She has twice won the Royal College of General Practitioners Research Paper of the Year Award and in 2001 received an OBE for services to Evidence Based Medicine.

Neal Maskrey is an Honorary Professor of Evidence-informed decision making at Keele University and consultant clinical adviser in the Medicines and Prescribing Centre, National Institute for Health and  Care Excellence, UK.

In this video, these experts explain the concept of real evidence based medicine (EBM) as it should be applied to real patients.

Note particularly 6.30 to 7.47

. . . if you look at the research literature on expert judgement you will find  that experts . . . don’t mechanically follow rules. They do something much more intuitive and much more rapid and what they then do is they come to a rapid decision and then they go back and unpack why they got to that decision and they justify it by using the evidence  . . . one of the things that clinicians say again and again is “I don’t want to be tyrannised by these guidelines. I don’t want my patients to be tyrannised by these guidelines.” And it seems that their clinical judgement is being challenged by these guidelines and what we want is for the clinical judgement to be supported by the guidelines so EBM will be delivered in a much more nuanced and granular way than people sometimes assume it should be.

Also 7.57 to 8.30

There are, of course, in every consultation two people involved in making the decision. The clinician has their own expertise and the patient has their own expertise.

How sad that, while the rest of the world is reassessing the concept of Evidence Based Medicine, Singapore is taking the backwards step of applying the guidelines in exactly the mechanical way that these experts feel should be avoided!

 

The evidence must come not from tests but from a thorough observation of the patient

Emeritus Prof Sir Gordon Arthur Ransome (1910-1978)

Today one of the four colleges at the Duke-NUS Graduate Medical School is named after Emeritus Prof Sir Gordon Arthur Ransome, remembered by many as the founder of modern medicine in Singapore and admired as an outstanding and brilliant clinician. His contributions to medicine in Singapore went back to 1938, when he was made Associate Professor of Medicine at the then King Edward VII College of Medicine. He also founded the Singapore Academy of Medicine and was its first Master.

The following is taken from an oration to mark Prof Ransome’s retirement in 1971: The life and times of Gordon Arthur Ransome by Seah Cheng Siang in Annals of the Academy of Medicine, January 1972, Vol. 1 (Bolding by HCS)

http://ams.edu.sg/view-pdf.aspx?file=media%5C591_fi_219.pdf&ofile=gar+01.pdf  

Foremostly, Professor Ransome taught by example. Himself a well-trained clinician, he has handed down to hundreds of doctors, clinical methods which were learnt from his teachers and also those innovated by his own increasing experiences.

In taking a meaningful medical history, he has on many occasions, and still does so now, sit by the bedside, eliciting point by point the story of the patient’s illness, with students watching on. From the history and adopting Lord Horder’s methods, a list of possible diagnoses to account for the presenting symptoms, is then compiled.

In front of the students, Professor Ransome will then examine the patient meticulously. A very careful inspection from head to foot is followed by an examination in minutia of the different systems. . .

From the signs culled, and with the results of some laboratory tests, he has nearly in every instance been able to arrive at a definitive diagnosis. A firm diagnosis by this method and not by intuition, is always teachable. He converted many a doctor from practising intuitive diagnosis into exercising a perceptive scientific method.

Another interesting insight into his powers of diagnosis comes from Sir Gordon Arthur Ransome  by Beng Yeong Ng and Jin Seng Cheah in Annals Academy of Medicine May 2008, Vol. 37 No. 5 (Bolding by HCS)

http://ams.edu.sg/view-pdf.aspx?file=media%5C614_fi_929.pdf&ofile=V37N5p426.pdf

 He taught from first principles and emphasised the importance of the use of the 5 senses in the practice of medicine. He placed importance on the art of listening, the essence of the artistry of bedside medicine. Effective listening involves all the senses, not merely the ears. To succeed in healing, a doctor must be trained, above all else, to listen. His skills as a diagnostician were renowned. He believed that X-rays findings tended to lag behind the physical signs. Without any laboratory tests, he was able to arrive at an accurate diagnosis just by taking a comprehensive history and examining the patient skilfully. He was nicknamed “kosong” (meaning “zero” in Malay) as he would give a student zero marks for poor performance in clinical examination. 

This letter from Dr Quek Koh Choon, one of Prof Ransome’s former students, appeared in the Sunday Times on 26 April 2015 and again highlights the importance Prof Ransome attached to observation – note “Tests and investigations were needed only to confirm the diagnosis. (Bolding by HCS)

http://www.pharmacychoice.com/News/article.cfm?Article_ID=1366630 

If Professor Gordon Arthur Ransome were alive today, he would be pleased to see how Singapore has become a great medical centre (“Prof hopes S’pore becomes medical hub”; last Sunday). 

I was privileged to have been taught by him, and to also have had the opportunity to work with him.

He taught me that the practice of medicine is not just a science, but also an art. He emphasised the need to observe the patient as he came into the consultation room – to watch his gait and facial expressions – and also advocated listening to the patient well.

These days, many patients say that many doctors are not listening enough to their complaints, and that they are quickly dismissed to undergo a battery of tests and investigations.

Prof Ransome did not think it wise to resort quickly to investigations. He believed that a great deal could be learnt from a patient’s history, and that astute observation and a thorough examination were key in clinching the diagnosis. Tests and investigations were needed only to confirm the diagnosis.

I used to accompany Prof Ransome on his ward rounds, and he surprised me when, at the end, he invited me to sit down with him and asked for my opinion of the various cases.

I was the most junior doctor then, and the experience certainly jolted me and taught me to value mutual respect among fellow colleagues and to be open to consider an opinion, even from a novice.

Prof Ransome treated all patients with respect and kindness, and did his best for them no matter what their status and background were. Once, he was called to attend to a VIP while examining a patient in a C ward. He said that the VIP had to wait as he was still attending to his patient.

He was a doctor devoted to the practice of medicine. He did not care much for accolades and prestige. Patients were his priority.

He was truly one of the great founders of modern medicine in Singapore. His inspirational values should be remembered by all who follow in the tradition of good doctors and healers.

Quek Koh Choon (Dr) 

We can only guess at what Prof Ransome would have thought of today’s Ministry Of Health insisting that all diagnosis be based only on test results and supposedly evidence based medicine. One can sense his disappointment and hear him cry, “What about the patient? The patient will tell you what’s wrong if you just listen! Just listen – with all your senses! I am giving you zero!”

 

Our Holy Miracle of the Infallible TSH Test

A beautiful video which sums up the ‘approved’ approach to thyroid treatment.

The Ministry Of Health insists that the Thyroid Stimulating Hormone (TSH) test is the be all and end all and punishes those doctors who question it. Meanwhile, many patients with normal TSH levels continue to feel unwell.

 

The Non-Science Witch Hunt Against Hormone Replacement Therapies for Deficiency Syndromes Must End: An A4M Position Paper on Physician-Prescribed HRT

The first paragraph of this Position Paper from The American Academy of Anti-Aging Medicine (A4A), 23 September 2013, seems to describe just what is happening in Singapore at the moment. (Bolding by HCS)

Since the inception of the anti-aging medical movement in 1991, various establishment parties have ruthlessly leveraged their positions of power in academic, political, and regulatory arenas for the purpose of attempting to limit the use of hormone replacement therapies (HRT) in adults with documented clinical deficiencies. For over 15 years, a prolonged and calculated campaign of deceit, fraud, and suppression has threatened physician licensures and liberties to treat and prescribe life-improving therapies, leading potentially to the direct compromise of patients’ health and longevity. Dozens of physicians have been sanctioned and punished with loss of license and academic standing. This pernicious abuse of position and power is particularly prevalent with regard to RECENT challenges made against human growth hormone (HGH), testosterone (TRT), and DHEA replacement therapies that are trumpeted by the mainstream media. Biased reporters frequently – and inappropriately – demonize legitimate physicians and clinical compounding pharmacies who are reluctantly positioned on the frontline of a decades’ old agenda to limit freedom of choice and information, and the physician’s most essential responsibility to select the best course of therapy and medication for their patients. . . .

A4M POSITION

The American Academy of Anti-Aging Medicine (A4M), its numerous worldwide affiliated scientific and medical societies, and befriended organizations, supports the judicious application of modern and advanced medical technologies to address the changes in chemical, hormonal, physical, and nutritional needs that occurs with aging. Such repletion includes the restoration of hormones to an optimal physiological state when deficiency is determined by objective assessment.

Hormone replacement therapy (HRT) is an essential and extensively documented protocol for clinical intervention in the disorders of aging. HRT maintains an unblemished safety and efficacy profile that has been documented by 20 years of clinical application. Yet, a perfect storm of misguided media combined with biased parties whose livelihoods hinge on disparaging the anti-aging medical movement has grossly compromised access to HRT, placing the lives of hundreds of thousands of patients worldwide in potential jeopardy.

Experienced anti-aging physicians have been prescribing HRT for more than 20 years. PubMed contains more than 20,000 peer-reviewed studies of HRT, of which a preponderance document the life-enhancing and/or life extending benefits of HRT in aging adults. See Appendix A “Literature Review“ which presents a selection of such studies that represent the objective evidence that supports the A4M position.

 

Read the rest of the paper at:

http://www.worldhealth.net/pdf/A4M-2013-Position-Statement-HRT.pdf

Is evidence-based medicine broken?

This article by Trish Greenhalgh, Professor of Primary Health Care and Dean for Research Impact at Barts and the London School of Medicine and Dentistry, looks at the controversy surrounding evidence based medicine.

She finds that (bolding by HCS)

. . . the attempted solution – hard-wiring the guidelines into computerized “decision support tools” – has been largely a flop, given computer models’ inability to accommodate messy, real-world clinical practice. For example, generations of medical students have memorized the textbook features of celiac disease for their examinations. But your Aunt Nora’s celiac disease has not read the textbook.

Indeed, only Aunt Nora can tell you how her celiac disease behaves. She also happens to be opposed to taking blue-colored pills. And she insists that, years ago, when she took drug x, it made her feel like a new woman – despite the fact that, in 1,000 patients, drug x has demonstrated, on average, no effect. The computer model’s treatment recommendations would probably not work for Aunt Nora.

But this does not mean that evidence-based medicine is broken; it simply lacks the needed maturity. High-quality randomized trials are as important now as they were at the time of the evidence-based movement’s founding. But the system must be shaped by the doctor’s judgment and the patient’s individual experience.
She later states:
. . . research-derived facts about the average patient must not outweigh individual patients’ observations of their own bodies and illnesses. New processes for capturing and accommodating patients’ personal experiences – which are typically idiosyncratic, subjective, and impossible to standardize – would go a long way toward ensuring that each patient receives the right treatment.

Read the whole article at:

http://www.project-syndicate.org/commentary/is-evidence-based-medicine-broken-by-trish-greenhalgh-2014-10

Who shall guard the guardians? Dr Malcolm Kendrick

A quick skim through this entry taken, with permission, from the blog of Dr Malcolm Kendrick, gives frightening insight into the bias and financial conflicts of interest often at play when various committees draw up the various “guidelines” we are all supposed to stick to in our health programmes. Yet if doctors do not stick rigidly to these guidelines, even though they feel that doing so is not in the best interest of their patient, they are in danger of having their practice licences revoked as has happened here in Singapore. The double standards working here are such a travesty of justice!

http://drmalcolmkendrick.org/2013/08/02/who-shall-guard-the-guardians/

Who shall guard the guardians?

(Quis custodiet ipsos custodes?)

Mainstream medicine increasingly relies on Guidelines. Well, they are called guidelines, but increasingly they carry the force of law. In many countries if you try to practice outside the wise and infallible guidelines you may lose your license to practice medicine. In the US, you may well be dragged into court, and if you have not been following the guidelines, you will be sued. You can even be gaoled (or jailed, as we say in the UK).

In short, guidelines are very serious and important things indeed, and they now rule medicine with a rod of steel. In the UK up to 50% of general practice time is spend ensuring that all patients are constantly monitored to ensure that various guidelines are rigorously followed. Is the BP low enough, the cholesterol low enough, have you checked blood sugar levels etc.

But where do guidelines come from – exactly? Who gives people the right to sit on guideline committees? What are the entrance requirements? Who shall guard the guideliners?

The answer is, perhaps shockingly, that there are almost no rules to this. If a group, such as the National Institutes for Health in the US, decides to set up a committee to decide on, for example, what is the healthy level for cholesterol lowering, what happens? They ask a number of Key Opinion Leaders to join the committee. In this case the NCEP (National Cholesterol Education Programme – which is a committee, not a programme).

In 2004 this committee decided that cholesterol levels should be lowered far more aggressively than in the past. Based on, as far as I could see, very flimsy evidence.  Could it be that that committee was, in some way, biased in favour of cholesterol lowering companies?  A number of people, including me, demanded to see if any of the eight invited members of this hugely important committee had financial conflicts.

With much reluctance, the conflicts were revealed (I have highlighted, in bold, the companies who marketed cholesterol lowering agents at the time.) See below

ATP III Update 2004:  Financial Disclosure of NCEP members

Dr. Cleeman: (Chairman) has no financial relationships to disclose.

Dr. Grundy: has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.

Dr. Bairey Merz: has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

Dr. Brewer: has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.

Dr. Clark: has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.

Dr. Hunninghake: has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.

Dr. Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.

Dr. Smith: has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.

Dr. Stone: has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.

http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm

Of course, as people have stated to me, the mere fact that there were seventy two financial conflicts of interest does not mean that the guidelines themselves were biased. But you know what, I don’t believe it. Imagine if eight Supreme Court judges, ruling on any issue, had seventy two direct financial conflicts of interest to do with that issue…..Well, the outcry would never end.

Yet doctors, it seems, are beyond any suspicion – of any sort. There is not the slightest possibility that any doctor would ever do anything wrong….We are, after all, superior beings. ‘But, what’s that you say skippy…. hold on.’

‘Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will ever be known…..

The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths

In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.’ http://cardiobrief.org/2013/07/31/european-heart-guidelines-based-on-disgraced-research-may-have-caused-thousands-of-deaths/

Oh well, maybe not.

The fact is that, wherever you look, guidelines are being developed by doctors who have widespread conflicts of interest. And if you go a step further back to review the studies that the guidelines are based on, they are run by, and written up by, doctors who have enormous conflicts of interest. Although sometimes, these conflicts are just…well, forgotten about.

For example, a few opinion leader were ‘named and shamed’ by the Journal of the American Medical Association, when someone pointed out that a number of the authors of the original paper they wrote might just have slipped up in declaring their conflicts:

Unreported Financial Disclosures in: ‘Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis.’

….the following disclosures should have been reported: “Dr Mora reports receipt of travel accommodations/meeting expenses from Pfizer; Dr Durrington reports provision of consulting services to Hoffman-La Roche, delivering lectures or serving on the speakers bureau for Pfizer, and receipt of royalties from Hodder Arnold Health Press; Dr Hitman reports receipt of lecture fees and travel expenses from Pfizer, provision of consulting services on advisory panels to GlaxoSmithKline, Merck Sharp & Dohme, Eli Lilly, and Novo Nordisk, receipt of a grant from Eli Lilly, and delivering lectures or serving on the speakers bureau for GlaxoSmithKline, Takeda, and Merck Sharp & Dohme; Dr Welch reports receipt of a grant, consulting fees, travel support, payment for writing or manuscript review, and provision of writing assistance, medicines, equipment, or administrative support from Pfizer, and provision of consultancy services to Edwards, MAP, and NuPathe; Dr Demicco reports having stock/stock options with Pfizer; Dr Clearfield reports provision of consulting services on advisory committees to Merck Sharp & Dohme and AstraZeneca; Dr Tonkin reports provision of consulting services to Pfizer, delivering lectures or serving on the speakers bureau for Novartis and Roche, and having stock/stock options with CSL and Sonic Health Care; and Dr Ridker reports board membership with Merck Sharp & Dohme and receipt of a grant or pending grant to his institution from Amgen. http://jama.ama-assn.org/content/307/16/1694.3.full?etoc

Not a bad little list. As you can see, Dr Ridker had board membership with Merck Sharp and Dohme…… a company that has made billions from selling statins. Now, here is he is authoring a paper on the benefit of statins (which will be used to develop guidelines on cholesterol lowering), and he simply forgot about this conflict of interest. As for the others, well, they’re also busy people; things must have just slipped their minds, such as thirty three separate financial conflicts.

For this terrible crime against the integrity of medical science, none of them can ever again do medical research, or author a medical paper, or sit on guideline committees. Cue, mad cackling laughter. As you may expect, absolutely nothing happened at all, apart from the publication of that statement you in the Journal in the American Medical Journal (JAMA).

I am sorry, but the system of developing guidelines is, frankly, bust. It has been for many years, but it is a very big and dangerous looking nettle to grasp, and no-one, currently has the will to do it.

Someone, somewhere, needs to ensure that guidelines, and the evidence they are based on, and the interpretation of that evidence, is of the highest quality – and free from potential bias, and financial conflicts of interest. We are about as far from this happy state of affairs as I am from being invited onto any guideline committee, ever, anywhere.

And that, my friend, is a very, very long way away indeed. You would need to Hubble telescope to see across distances as vast as that.

 

Note from HCS:

Dr Kendrick’s latest book, “Doctoring Data”, to be officially launched this year, is available at http://doctoringdata.co.uk/

After reading this book you will know what to believe and what to ignore. You’ll have a much better understanding of the world of medical research. A world in crisis.

 

Where does the evidence come from?

The circulars which the Ministry Of Health (MOH) has sent to all clinics in Singapore call for all treatment to be “evidence based medicine”. Their definition of this concept has not been given.  One of the reference sources on the MOH website (Duke University, Introduction to Evidence-Based Medicine) gives us this definition from David Sackett, the founding father of the concept of evidence based medicine (bolding by HCS):

Evidence Based Practice (EBP) is the integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care. Clinical expertise refers to the clinician’s cumulated experience, education and clinical skills. The patient brings to the encounter his or her own personal and unique concerns, expectations, and values. The best evidence is usually found in clinically relevant research that has been conducted using sound methodology.

(Sackett, D. (2002) Evidence-based Medicine: How to Practice and Teach EBM, 2nd edn. London: Churchill Livingstone.)

The Duke University website goes on (bolding by HCS):

The evidence, by itself, does not make the decision, but it can help support the patient care process. The full integration of these three components into clinical decisions enhances the opportunity for optimal clinical outcomes and quality of life. The practice of EBP is usually triggered by patient encounters which generate questions about the effects of therapy, the utility of diagnostic tests, the prognosis of diseases, and/or the etiology of disorders.

http://guides.mclibrary.duke.edu/c.php?g=158201&p=1036021

The analysis below is taken from Evidence Based Practice, McGraw-Hill Education (bolding by HCS):

Sackett acknowledges and values the different types of knowledge held by the clinician, for example, knowledge acquired through cultural and personal experiences, logical and critical knowledge gained through curriculum and the extra insight that can only be acquired through cumulative clinical expertise. He values the patient as an empowered decision maker and highlights that not all research is transferable into practice due to flaws in either design or reason.

https://www.mheducation.co.uk/openup/chapters/9780335244737.pdf

Note that Sackett states that the best evidence is usually found in what the MOH would call “relevant research”. However, when the evidence found in laboratory tests is responded to with finely adjusted bioidentical hormone replacement (including desiccated thyroid) there is ample evidence available provided by well-respected doctors worldwide (some of it on this site) that patients are receiving the care they need and, further, the care that addresses “the patient’s unique concerns, expectations, and values”.

Interestingly Sackett refined his position. Taken from Too Many Experts Spoil The Science, 8 May 2000 (Bolding by HCS):

http://www.abc.net.au/cgi-bin/common/printfriendly.pl?/science/news/health/HealthRepublish_124166.htm

According to the founder of Evidence Based Medicine experts are hindering the healthy advancement of science. Writing in this week’s British Medical Journal (BMJ), Canadian-based researcher, David Sackett, said that he would “never again lecture, write, or referee anything to do with evidence based clinical practice”. Sackett is not doing this because he has ceased to believe in evidence based clinical practice but, as the BMJ comments, because he is worried about the power of experts in stifling new ideas and wants the retirement of experts to be made compulsory.

Sackett claims that the prestige of experts (including himself) gives their opinions far greater persuasive power than they deserve on scientific grounds alone. “Whether through deference, fear, or respect, others tend not to challenge them, and progress towards the truth is impaired in the presence of an expert,” he writes.

He also argues that expert bias against new ideas operates during the review of grant applications and manuscripts. “Reviewers face the unavoidable temptation to accept or reject new evidence and ideas, not on the basis of scientific merit, but on the extent to which they agree or disagree with the public positions taken by experts on these matters.

(Sackett’s article: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118019/)

In response to this, Dr Malcolm Kendrick comments on his blog You Are Killing Patients:

My rather cynical view is that experts can be compared to those men (usually men) who have grabbed hold of the microphone at the front of a mob during a protest march. With this simple act they have managed to gain status and authority. Shortly after they become spokesmen for the revolutionary movement, then leaders…then despots.

However, most newspapers, journalists, television producers never ask they question, how did an expert become an expert – what makes them so. Instead, they are completely in the thrall of the ‘experts’, and greatly fear their power. Which means that when an eminent professor loads and fires the ‘you’re killing patients’ gun, all hell breaks loose and panic stalks the land. Journalists, newspaper editors, TV producers and suchlike quiver in fear. They instantly retract everything they have ever published on the matter, and promise never to do it again.

http://drmalcolmkendrick.org/2014/06/04/you-are-killing-patients/

The topic of evidence based medicine is one that stirs controversy. Surely the patient themselves should provide some of the evidence – if it works, and it hasn’t killed anyone, don’t ban it. If it works and I feel good on it, I want to continue using it. Recently there has been much debate about the safety of supplements. However, every year more than 106,000 people die from reactions to prescription medicine. The last year we have data for, which was 2013, the number of people who died from taking a nutrient was zero. Surely that is “evidence” of their safety, if not of their efficacy?