Dr John McDougall
Undeniable Evidence: Diabetes Treatments Do More Harm Than Good
Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes by William Duckworth in the December 17, 2008 issue of the New England Journal of Medicine found, “Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications.”1This study, called the Veterans Affairs Diabetes Trial (VADT) was of 1791 military veterans (mean age 60.4 years) who had a suboptimal response to therapy for type-2 diabetes. They were assigned to receive either intensive- or standard-glucose control and studied for 5.6 years. The intensive-therapy reduced the Hemoglobin A1c levels to 6.9%; compared to 8.4% in the standard-therapy group. The patients were also put on aspirin and a statin.
A weight gain of 18 pounds occurred with the intensive-treatment compared to 9 pounds with standard-therapy. There were 95 deaths from any cause in the standard-therapy group and 102 in the intensive-therapy group. In the intensive-therapy group, the number of sudden deaths was nearly three times the number as those in the standard-therapy group (11 vs. 4). More patients in the intensive-therapy group had at least one serious adverse event, predominantly hypoglycemia, than in the standard-therapy group.
These pharmaceutical companies—Sanofi-Aventis, GlaxoSmithKline, Novo Nordisk, Roche, Kos Pharmaceuticals, and Amylin—provided medications and financial support for the study.
Comment: This is the third industry-funded study published this year showing aggressive treatment hurts patients. On June 12, 2008 the ACCORD* trial and ADVANCE** trials were also published in the New England Journal of Medicine.2,3Together, the effect of these three well-designed randomized studies should be enough to halt aggressive prescribing of diabetic pills and insulin to type-2 diabetics.Will this overwhelming evidence change how doctors practice? Probably not. Drug companies have millions of advertising dollars dedicated to emphasizing any slight benefits their drug treatments may show and minimizing the harms. In this manner they convince doctors to prescribe and patients to buy useless and harmful products. Most doctors are too afraid of lawsuits to stand up for the patients and against the drug companies. To change current practice, doctors need to fear being sued for too aggressively treating patients. Even more, they need to fear being sued for failing to prescribe the correct treatment for type-2 diabetics—a change in diet. None of these three studies published in one of the world’s most prestigious medical journals taught dietary and lifestyle modification to their patients.
Currently, Food and Drug Administration (FDA) approval for a diabetic medication requires evidence that the drug will lower blood sugar—not that it improves the patient’s life. The title of my February 2008 newsletter describes the results of such narrowly focused therapy: “Intensive Therapy Means Dying Sooner with Better Looking Numbers.” The FDA is as of December 2008 recommending that all new drugs developed for the treatment of type-2 diabetes show that they do not increase the risk of cardiovascular events. However, this is not a requirement, just a recommendation or suggestion to the pharmaceutical companies.4
Eating the rich western diet causes type-2 diabetes. My February 2004 newsletterprovides details on the cause and how a change in diet will cure essentially all type-2 diabetics—at the same time causing them to lose weight, reverse heart disease, and dramatically improve their overall health.
*ACCORD = Action to Control Cardiovascular Risk in Diabetes
**ADVANCE = Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation
1) Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; the VADT Investigators. Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes. N Engl J Med. 2008 Dec 17. [Epub ahead of print]
2) Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59.
3) ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72.