Category Archives: Evidence Based Medicine

Is medical research now beyond redemption? Dr Malcolm Kendrick

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The following entry is taken, with permission, from the blog of Dr Malcolm Kendrick, a GP in Macclesfield, UK, an original member of the Centre for Evidence Based Medicine in Oxford and of The International Network of Cholesterol Sceptics (THINCS). He describes his blog thus:

This blog is my best effort at providing some balance to the increasingly strident healthcare lobby that seems intent on scaring everyone about almost everything. Is there a foodstuff that is safe to eat anymore? Is there any activity that does not cause cancer or heart disease?

http://drmalcolmkendrick.org/about/

 

Is medical research now beyond redemption?

(Bolding by HCS)

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Below, I have copied an entire article from the BMJ, written by Dr Des Spence, who is a fellow Scottish GP. We communicate from time to time, and share a general view that medicine is heading in a very unfortunate direction with overdiagnosis and over-treatment/polypharmacy becoming a massive problem.

This is driven, in the main part, by the pharmaceutical industry. An industry that would like to see the entire population of the world taking medication every day….. forever. To achieve this they have, effectively, grabbed hold of medical research and twisted it to their own ends.

Anyway, please read this article. It encapsulates much of what I feel, and I believe it needs a wider audience [I have added a few comments into the text to ensure that I am not breaching copyright]

Evidence based medicine (EBM) wrong footed the drug industry for a while in the 1990s. We could fend off the army of pharmaceutical representatives because often their promotional material was devoid of evidence. But the drug industry came to realise that EBM was an opportunity rather than a threat. Research, especially when published in a prestigious journal, was worth more than thousands of sales representatives. Today EBM is a loaded gun at clinicians’ heads. “You better do as the evidence says,” it hisses, leaving no room for discretion or judgment. EBM is now the problem, fuelling overdiagnosis and overtreatment.

[This is now a major problem for GPs who are increasingly measured and monitored, and funded, according to how accurately we follow guidelines mk comment] [And in some cases in Singapore, barred from running their practices. HCS]

You see, without so called “evidence” there is no seat at the guideline table. This is the fundamental “commissioning bias,” the elephant in the room, because the drug industry controls and funds most research. So the drug industry and EBM have set about legitimising illegitimate diagnoses and then widening drug indications, and now doctors can prescribe a pill for every ill.

[As you can imagine, this makes it difficult not to prescribe statins mk comment]

The billion prescriptions a year in England in 2012, up 66% in one decade, do not reflect a true increased burden of illness nor an ageing population, just polypharmacy supposedly based on evidence. The drug industry’s corporate mission is to make us all sick however well we feel. [Absolutely true mk comment] As for EBM screening programmes, these are the combine harvester of wellbeing, producing bails of overdiagnosis and misery.

Corruption in clinical research is sponsored by billion dollar marketing razzmatazz and promotion passed off as postgraduate education. By contrast, the disorganised protesters have but placards and a couple of felt tip pens to promote their message, and no one wants to listen to tiresome naysayers anyway.

[Speaking as a tiresome naysayer, I could not agree more mk comment]

How many people care that the research pond is polluted, with fraud, sham diagnosis, short term data, poor regulation, surrogate ends, questionnaires that can’t be validated, and statistically significant but clinically irrelevant outcomes? Medical experts who should be providing oversight are on the take. Even the National Institute for Health and Care Excellence and the Cochrane Collaboration do not exclude authors with conflicts of interest, who therefore have predetermined agendas. The current incarnation of EBM is corrupted, let down by academics and regulators alike.

[If anyone has any suggestion how to improve regulation, please let me know mk comment]

What do we do? We must first recognise that we have a problem. Research should focus on what we don’t know. We should study the natural history of disease, research non-drug based interventions, question diagnostic criteria, tighten the definition of competing interests, and research the actual long term benefits of drugs while promoting intellectual scepticism. If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen.

[There have already been many disasters, but nobody has yet listened mk comment]

Original article can be found here

Sorry about the intrusive comments, but I don’t want the BMJ jumping up and down on me – especially as they are the only major journal that seems keen to criticize the industry.

What Des Spence is saying, is what I have been saying for some time now. Evidence Based Medicine (EBM) could have been a great thing – so long as it was not enforced too rigidly. But the evidence has been manipulated and corrupted all the way along the line. EBM is now almost completely broken as a tool to help treat patients.

Some years ago I stated that I no longer believe in many research papers that I read. All I tend to do is look at the authors, look at the conflicts of interest, look at the companies who sponsored the study, and I know exactly what the research is going to say – before I have even read the paper.

I have also virtually given up on references. What is the point, when you can find a reference to support any point of view that you want to promote? Frankly, I do not know where the truth resides any more. I wish to use evidence, and the results of clinical studies, but I always fear that I am standing on quicksand when I do so.

We are at a crisis point. Medical research today (in areas where there is money to be made) is almost beyond redemption. If I had my way I would close down pubmed, burn all the journals, and start again, building up a solid database of facts that we can actually rely on – free from commercial bias. But this is never, ever, going to happen.

 

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.

 

The Nasty Secret About Your Drug Prescription

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Maybe evidence based medicine isn’t all it is made out to be. This article by Carl Lowe is taken from the Easy Health Options website, reprinted with permission.

http://easyhealthoptions.com/nasty-secret-drug-prescription/#

(Bolding by HCS)

A large, bureaucratic structure supervised by the Food and Drug Administration (FDA) is supposed to regulate the approval of prescription pharmaceuticals to make sure they are effective and safe. A study at Yale analyzing how this approval system works, however, is not reassuring.

The researchers at the Yale School of Medicine note that doctors and their patients believe that the FDA carefully scrutinizes the drugs it approves. But their analysis of drugs approved between 2005 and 2012 demonstrates that many pharmaceuticals go on the market even though little is known about their safety. Or if they even work.

“We found that during the study period, more than one-third of the drugs were approved on the basis of a single trial, without replication, and many other trials were small, short, and focused on lab values, or some other surrogate metric of effect, rather than clinical endpoints like death,” says researcher Nicholas S. Downing.

The Yale research team examined the clinical trials that were used by the FDA to justify approval by the agency. In this study, the researchers investigated the key features of the trials – how many people were involved, how long the trials lasted and the results.

“Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials,” says researcher Joseph Ross. “There was a lack of uniformity in the level of evidence the FDA used.”

In other words, some drug trials were big enough and long enough to be convincing that the drugs being tested were safe and effective. But many others were too short, too small and too inconclusive to prove anything.

But that didn’t stop the FDA from giving the thumbs up to many unproven drugs. One of which you might be taking right now.

And a lot of times, the FDA approves a new drug when an older drug is more effective and has been found to be safer and free of side effects.

“We also found that only 40 percent of drug approvals involved a clinical trial that compared a new drug to existing treatment offerings,” says Ross. “This is an important step for determining whether the new drug is a better option than existing, older drugs.”

The next time somebody tries to warn you about the regulatory process that allows vitamin and mineral supplements (HCS: or your BHRT !) on the market, ask them what they know about the approval process of those “proven” prescription drugs. Every year more than 106,000 people die from reactions to prescription medicine. That’s about 2,000 people a week.

The number of people who die each year from taking a vitamin or mineral? The last year we have data for, which was 2013, the number of people who died from taking a nutrient was zero.

Third of Drug Trials Are ‘Unscientific’

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From What doctors don’t tell you, 11 September  2014

http://www.wddty.com/third-of-drug-trials-are-unscientific.html

A third of published medical trials have come up with a false conclusion—usually one that favours the drug or therapy being reviewed. In other words, there’s no scientific proof that many of the drugs we take are effective or safe. The best-known example of data ‘misrepresentation’ concerns the antiviral drug, Tamiflu (oseltamivir), which was considered an effective treatment against influenza A and B viruses. But other researchers who reanalysed the data discovered its effectiveness had been overstated and its side effects downplayed. Researchers from Stanford University School of Medicine took another look at the data used in 38 published randomised clinical trials, considered the ‘gold standard’ of medical research—and found that 35 per cent came to conclusions that weren’t supported by the data. Most of the studies were paid for by the manufacturer of the drug being assessed. It wasn’t just drugs that were shown in a better light by researchers. One therapy, sclerotherapy, which treats enlarged and bleeding veins in the esophagus, reduces mortality but doesn’t stop the bleeding, the original study concluded. But on renalaysing the data, the Stanford researchers found exactly the opposite: the therapy stopped the bleeding but didn’t affect the rate of death.

The Slippery Slope: A Bittersweet Diabetes Economy

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While not directly related to bioidentical hormone replacement or natural desiccated thyroid therapy, this article is a depressing insight into the workings of the drug industry and the FDA and the money involved while concerns with the best treatment for patients seem to be side-lined.

The Slippery Slope: A Bittersweet Diabetes Economy

Special Reports: 21 December 2014

http://www.medpagetoday.com/Endocrinology/Diabetes/49227

Previous Editor of the British Medical Journal Makes an Admission

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Richard Smith, the previous editor of the British Medical Journal, recently published an article in that journal entitled Are some diets ‘mass murder’? (British Medical Journal, 15 December 2014.) While the article was related to diet (he was explaining that, after reading Nina Teicholz’s book The Big Fat Surprise,  he now feels that the dietary advice given by western medicine about saturated fat for the last fifty years or so is complete nonsense), the sentiments expressed relate to many areas of general medical wisdom handed out to the public by the FDA and various health authorities.

He states that, ”…the forensic demolition of the hypothesis that saturated fat is the cause of cardiovascular disease is impressive. Indeed, the book is deeply disturbing in showing how overenthusiastic scientists, massive conflicts of interest, and politically driven policy makers can make deeply damaging mistakes. Over 40 years I’ve come to recognise which I might have known from the beginning – that science is a human activity with the error, self-deception, grandiosity, bias, self-interest, cruelty, fraud, and theft that is inherent in all human activities (together with some saintliness), but this book shook me.”

(Bolding by HCS)

OECD calls for progress on thyroid disruptor testing

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The mission of the Organisation for Economic Co-operation and Development (OECD) is “to promote policies that will improve the economic and social well-being of people around the world”. Recently, 16-17 October 2014, the OECD Advisory Group on Endocrine Disrupters Testing and Assessment met to discuss the development and update of Test Guidelines and related documents for the testing and assessment of endocrine disrupters.

Member countries are being encouraged to develop non-animal test methods for the detection of thyroid disruptors. Highlighting the fact that the thyroid pathway is an important endocrine system, OECD believes that more efficient methods of testing are required and that advancements in such testing should be “very high priority” in order for accurate screening and assessment of endocrine disruption in humans and wildlife to be detected.

See Chemical Watch, 22 October 2014, OECD calls for progress on thyroid disruptor testing

https://chemicalwatch.com/21599/oecd-calls-for-progress-on-thyroid-disruptor-testing

FDA’s Latest Testosterone Bashing Proven Bogus… TWICE

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From Dr Mark Stengler’s House Calls Newsletter, 20 March 2015

http://www.besthealthnutritionals.com/blog/2015/03/20/new-testosterone-safety-confirmed/

(Bolding by HCS)

It’s always fun watching the FDA fall flat on its face, and it happens all the time – but it doesn’t always happen out in public for everyone to see.

But last week, the agency took a spectacular tumble in full view of the entire world.

Just one day after issuing a new warning on testosterone – just one day after claiming that hormone supplements could pose heart risks in men – two new studies proved just the opposite.

Both studies found no statistical increase in the risk of heart problems, and one of them even found no difference in the risk of heart attack, stroke and death.

Yes, on Tuesday, the FDA issued a warning claiming testosterone is dangerous. On Wednesday, it’s proven wrong . . . TWICE.

It’s almost funny, but this is no laughing matter – because the two studies proving testosterone is safe didn’t get the big headlines. The FDA’s warning, on the other hand, did. It was seen by millions of American men, including many who may need testosterone therapy and perhaps won’t get it now because of the warning.

These men will needlessly suffer from conditions such as low energy, weight gain, depression and sexual dysfunction.

Even worse, some of them may die – because testosterone therapy isn’t only safe for the heart, in some cases it could be absolutely essential to your very survival.

One study last year found testosterone therapy can cut the risk of heart attack by 30 percent in men who are at risk for cardiac problems. And just a few months ago, a major study found testosterone therapy can reduce the risk of heart attack and even death.

Low testosterone becomes increasingly common as we get older. If you’re past middle age yourself, there’s a good chance your own hormone levels have dropped – especially if you’ve been suffering from weight gain, low energy, mood disorders and erectile dysfunction.

In some cases, you can boost your levels with supplements. In others, you may need natural bioidentical hormones.

A holistic doctor can run a simple test to determine what your levels are and then help you decide the best way to increase them if necessary

The Studies:

Effect Of Testosterone Therapy On Adverse Cardiovascular Events Among Men: A Meta-Analysis, presented on 15 March 2015 at the American College of Cardiology’s 64th Annual Scientific Session in San Diego.

http://www.google.com.sg/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CBwQFjAA&url=http%3A%2F%2Fcontent.onlinejacc.org%2Fpdfaccess.ashx%3FResourceID%3D9514124%26PDFSource%3D13&ei=6aAfVYKhFoufugSQwoCYAQ&usg=AFQjCNEuefFBF1DwjnDyi_DEkSfrbH-C5Q&sig2=cxwva8FsMo0lmq5N5wHjdA&bvm=bv.89947451,d.c2E

Effects of Testosterone Supplement Therapy on Cardiovascular Outcomes in Men with Low Testosterone, presented on 14 March 2015 at the American College of Cardiology’s 64th Annual Scientific Session in San Diego.

https://www.google.com.sg/#q=content.onlinejacc.org%2Fdata%2FJournals%2FJAC%2F933568%2F13468.pdf%3Fv…

 

 

The Confusion Continues

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Unfortunately, in the year since this Hormone Choice Singapore (HCS) website was started, the confusion about bioidentical hormone replacement therapy in Singapore has continued, creating a great deal of stress for patients who suddenly find their hormone treatment (including desiccated thyroid) no longer available or difficult to find and for doctors who are unsure whether they are    going to be penalised if they continue to give the healthcare they know is of such great benefit to their patients.

In March 2015 the Ministry of Health (MoH) sent two new circulars  to Licensees/Managers of Clinics.

Testosterone For Hormone Replacement – eLis – Ministry 

MoH Letter 2

Moh Letter 3

There was some confusion in the first circular in that none of the doctors consulted by HCS had heard of intravenous thyroid therapy being used for the conditions listed. The second circular containing a clarification of the first seemed to underline MoH’s own confusion. It is also not clear whether this guideline refers to synthetic or bioidentical testosterone hormone replacement.

In the second circular the second sentence in the second bullet is particularly interesting: “If there is laboratory confirmation of testosterone deficiency, then the use of testosterone would not be considered as non-evidence based”.  In the opinion of both the doctors and patients HCS has spoken to, if this definition is followed, none of the bioidentical hormone replacement therapy used in

Singapore is non-evidence based, since all doctors who use it only do so with the guidance of regular laboratory blood tests. Indeed this is the joy of it, in that doses can be individually adjusted to reflect the tiniest change shown up in a blood test. This exact matching of the treatment to the individual patient is something that synthetic drugs cannot accommodate.

The circulars continue to call for “evidence based medicine”. One of the reference sources (Duke University, Introduction to Evidence-Based Medicine)  on the MoH website 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.

(The analysis below is taken from Evidence Based Practice, McGraw-Hill Education: https://www.mheducation.co.uk/openup/chapters/9780335244737.pdf  )

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.

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”.

Since bioidentical hormone therapy is derived from a plant source that cannot be patented, little money is likely to be made available  for expensive studies to match those funded by drug companies who stand to make mega-bucks from any drug produced as a result. Nevertheless, those patients who continue to use the hormones all over the world constitute a huge body of “evidence” of their value, while well-run studies continue to point out the flaws, clinical and ethical, in synthetic hormone replacement therapy.

Conversion to Armour Thyroid from Levothyroxine Improved Patient Satisfaction

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An interesting article by Gary M. Pepper & Paul Y.  Casanova-Romero in the Journal of Endocrinology, Diabetes & Obesity,  2(3): 1055, (2014), which contains this telling sentence:

. . . treatment of hypothyroidism with levothyroxine (L-T4) monotherapy has been the standard of care in the United States for over 3 decades. This is despite the reported failure of this form of therapy to result in satisfactory resolution of symptoms in a portion of treated individuals.

Abstract

The use of Armour Thyroid (natural desiccated thyroid) in the treatment of hypothyroidism has generated debate among endocrinologists although there is evidence that a significant percentage of patients prefer this medication to T4-only replacement strategies. In this retrospective analysis we investigate the preference for replacement therapy of patients with persistent subjective symptoms of  hypothyroidism on T4-only treatment who subsequently switched to Armour Thyroid (AT).

Methods: 450 consecutive patients being treated for hypothyroidism were screened. Of these, 154 had been switched from either generic or brand T4 replacement to AT for treatment of persistent symptoms of hypothyroidism. Patients undergoing treatment for thyroid cancer or on suppression therapy for nodular thyroid disease were excluded. Patients were instructed to have their blood sampled for thyroid function testing in the morning after taking their medication. After a minimum of 4 weeks on medication patients were asked to compare AT treatment versus T4-only treatment using a 5 point satisfaction rating scale. Results are reported as mean ± SD.

Results: On a 5 point Satisfaction Rating Scale with “5” indicative of the highest level of satisfaction, 117 (78.0%) patients gave a score of greater than “3” in preference for AT. Three patients treated with AT and one treated with LT4 reported adverse events, all minor. TSH was 1.30 ± 1.9 mIU/L and T3 1.81 ± 0.78 pmol/L on L-T4 monotherapy while TSH was 1.27 ± 2.2 mIU/L and T3 2.31 ± 1.33 pmol/L on AT (NS for TSH and p<0.003 for T3 ). T4 to T3 ratio on L-T4 monotherapy was 8.45 ± 3.7 while it was 4.70 ± 2.0 (p<0.001) on AT. There was no significant change in weight after switching to AT.

Conclusion: AT treatment produced high satisfaction scores in a group of hypothyroid patients with persistent symptoms on L-T4 therapy. Our findings suggest that AT preference is not due to placebo effect, induction of hyperthyroidism or weight loss. No significant untoward effects of this therapy were noted inclusive of 30 subjects 65 yrs of age and older. As suggested by Hershman [20], AT seems no more dangerous than adding T3 to L-T4 therapy and can be offered to patients who “don’t feel normal” on L-T4 monotherapy. Larger prospective studies would help clarify what role AT plays in replacement therapy of   patients dissatisfied with L-T4 monotherapy for hypothyroidism. Our results are encouraging to clinicians that this drug does provide a viable treatment alternative.

ABBREVIATIONS

TSH: Thyroid Stimulating Hormone; L-T4: Levothyroxine; T4: Thyroxine; T3: Triiodothyronine; AT: Armour Thyroid; L-T4 levothyroxine; NT: No Thyroid Disease; SRS: Satisfaction Rating Scale

See the full article at:

http://www.jscimedcentral.com/Endocrinology/endocrinology-2-1055.pdf