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 ⇑
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
so the complexities of diabetes are reduced to simply lowering blood sugar.
What is the annual cost of pursuing
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
(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
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been withdrawn; pioglitazone has been linked to bladder cancer; and exenatide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
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
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.
Cite this as: BMJ 2013;346:f2695
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
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.
Health and Social Care Information Centre.
Analysis—England, 2012. April 2013. www.hscic.gov.uk/catalogue/PUB10610.
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.
FREE Full Text
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.
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.
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.
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.
Richter B, Bandeira-Echtler E, Bergerhoff K,
Clar C, Ebrahim SH. Rosiglitazone for type 2 diabetes mellitus. Cochrane
Database Syst Rev2007;3:CD006063.
Ooi CP, Loke SC. Colesevelam for type 2 diabetes
mellitus. Cochrane Database Syst Rev2012;12:CD009361.
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.
British National Formulary (BNF). www.bnf.org/bnf/index.htm.
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.
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.
From Worstpill.org: 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
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