A recent article in the British Medical Journal by a Scottish general practitioner reminded me of a book about diabetes pills that we published 35 years ago telling much the same story…. When our book Off Diabetes Pills was published in 1978, none of the diabetes pills available in the U.S. had evidence, beyond lowering blood sugar, of a positive effect on mortality or a reduction in cardiovascular disease… A major reason for our writing this book was that back in the 1970s, there was already some evidence of harm from oral diabetes drugs. Since then, the number of harmful diabetes pills has greatly increased, with several so dangerous they had to be banned. These included phenformin, which caused often-fatal lactic acidosis, and troglitazone, which caused frequently fatal liver failure. Most recently, the widely used rosiglitazone (AVANDIA) was banned in Europe in 2010 due to increased cardiovascular risk, including heart attacks and heart failure. Worst Pill

The point of taking a drug is improvement of life quality.  To change a surrogate end-point, blood glucose without improving health or extending life is a hollow victory.  To do so with risk of serious side effects, expense, and inconvenience is a bad choice.  For how had PhARMA is, please read http://healthfully.org/rc/id1.html and http://healthfully.org/rc/id9.html --jk

http://www.bmj.com/content/346/bmj.f2695?ijkey=E4DHSRQzgZwTWOT&keytype=ref

Bad medicine: the way we manage diabetes

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2695 (Published 29 April 2013)

Cite this as: BMJ 2013;346:f2695

Type 2 diabetes is a modern plague largely brought on by lifestyle and is considered a progressive, non-reversible condition. The polypharmacy of chronic disease is the drug industry’s lottery win, and no more so than in diabetes, with new drugs and the increasing use of analogue insulin in type 2 diabetes worth tens of billions of pounds worldwide.¹ ⇑

The drug industry’s business plan for diabetes follows a familiar pattern:

·         (1) Conduct questionable research and control the original data.

·         (2) Schmooze the politicians, health regulators, and patient groups to suggest under-treatment and need for “urgent action.”

·         (3) Recruit tame diabetologists, massage them with cash, and get them to present at marketing events that masquerade as postgraduate education.

·         (4) Pay doctors to switch to newer drugs in dubious international post-marketing “trials.”²

·         (5) Seek endorsement from the National Institute for Health and Care Excellence to bully doctors to treat diabetes aggressively with drugs.³

And so the complexities of diabetes are reduced to simply lowering blood sugar.

What is the annual cost of pursuing this reductionist, drug based approach? In the past decade, spending on insulin in the UK has risen 300%, to £311m⁴ (€356m; $463m), and on oral diabetic drugs 400%, to £277m. And have you ever wondered why companies generously give away glucose meters? Test strips are a £166m market, the value of which has risen 300% in 15 years.⁴ Factor in staff time (when not attending more educational updates sponsored by the drug industry) and the patient and family’s time, and you have a great but expensive business.  But do analogue insulins, new diabetic drugs, and self monitoring of blood glucose improve outcomes? Does even tight glycaemic control make a difference? No data on mortality or morbidity exist for the new therapeutics.^{5 6 7 8 9 10 11} Likewise intensive glycaemic control is not superior with respect to mortality and cardiovascular disease.¹² So billions of pounds are being spent chasing a ghostly surrogate endpoint: low blood sugar. Worse, there is evidence that these new drugs cause harm. Rosiglitazone has already been withdrawn; pioglitazone has been linked to bladder cancer; and exenatide and sitagliptin double the risk of acute pancreatitis.^13 14 All this is an example of the scientific illusion that is so called evidence based medicine, where research is just mechanically reclaimed statistics pulped into junk educational nuggets—mere marketing by another name.  There remains another fundamental question. Can diabetes be reversed or cured by weight loss? A small, well designed study of 11 patients irrefutably showed that it can.¹⁵ And clinical effect is more important than any statistically significant yet clinically undetectable effect that a huge study funded by the drug industry might find. The therapeutic approach in diabetes is upside down. Incredibly, spending on diabetes drugs could employ 40 000 personal trainers. The complicity of doctors and lack of dissent against the drug model of diabetes care is bad medicine.

Notes

Cite this as: BMJ 2013;346:f2695

Footnotes

·         Provenance and peer review: Commissioned; externally peer reviewed.

·         Follow Des Spence on Twitter @des_spence1

References

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Cohen D, Carter P. How small changes led to big profits for insulin manufacturers. BMJ2010;341:c7139.

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Gale EA. Post-marketing studies of new insulins: sales or science? BMJ2012;344:e3974. 

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National Institute for Health and Care Excellence (NICE). Blood-glucose-lowering therapy for type 2 diabetes. April 2013. http://pathways.nice.org.uk/pathways/diabetes#path=view%3A/pathways/diabetes/blood-glucose-lowering-therapy-for-type-2-diabetes.xml&content=view-node%3Anodes-considering-triple-therapy.

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Health and Social Care Information Centre. Prescription Cost Analysis—England, 2012. April 2013. www.hscic.gov.uk/catalogue/PUB10610.

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Davidson MB. Counterpoint: self-monitoring of blood glucose in type 2 diabetic patients not receiving insulin: a waste of money. Diabetes Care2005;28:1531-3.

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Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;2:CD005613.

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Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, Rutten GE, Van Weel C. Alpha-glucosidase inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev2005;2:CD003639.

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Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev2011;10:CD006423.

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Black C, Donnelly P, McIntyre L, Royle PL, Shepherd JP, Thomas S. Meglitinide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;2:CD004654.

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Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim SH. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;3:CD006063.

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Ooi CP, Loke SC. Colesevelam for type 2 diabetes mellitus. Cochrane Database Syst Rev2012;12:CD009361.

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Hemmingsen B, Lund SS, Gluud C, Vaag A, Almdal T, Hemmingsen C, et al. Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database Syst Rev2011;6:CD008143. 

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British National Formulary (BNF). www.bnf.org/bnf/index.htm.

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Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med2013;173:534-9.

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Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia2011;54:2506-14.

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