The operation was a success, but the patient died
Today, the field of medicine received a long-needed shot in the arm. In their article, "Redefining Quality--Implications of Recent Clinical Trials ," published in the June 12 issue of the New England Journal of Medicine, Doctors Harlan Krumholz and Thomas Lee challenged medical colleagues to improve their understanding of clinical trial results and to design medical strategies that affect overall patient health outcomes - not simply isolated risk factors.
Quoting study after study, including the ILLUMINATE (Investigation of Lipid Level Management to Understand Its Impact in Atherosclerotic Events) trials to lower LDL and increase HDL cholesterol, the ENHANCE (Effect of Combination Ezetimbe and High-Dose Simvastatin Versus Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygotes Familial Hypercholesterolemia) trials to reduce LDL cholesterol, the ACCORD (Action to Control Cardiovascular Risk in Diabetes) and the ADVANCE (Action in Diabetes and Vascular Disease) trials to reduce serum glucose levels and the Women's Health Initiative Hormone Replacement Therapy trials all achieved their primary goals. They all reduced the risk factor they were focused on, but in all cases, patients experienced increased cardiovascular mortality. Even though the specific risk factor was reduced, increased numbers of patients died. They were all classic cases of, "The operation was a success, but the patient died."
To quote from the Krumholz and Lee paper,
"A clinical trial is ultimately a test of strategy, and we should not be surprised that different strategies may have different effects on patients beyond their effect on risk-factor levels."
The problem is that this shot in the arm for logic and medical sense is unlikely to be the shot heard 'round the world. While many researchers and practitioners in the medical community have long proclaimed the same advice regarding consideration of risk factors versus overall health outcomes, they appear to be in the minority and are largely ignored by the medical 'establishment.' For decades, the issue of salt and health within the medical community has revolved around the impact of salt on one risk factor - blood pressure. Several eminent physicians and the Salt Institute have long stated that it's not blood pressure that has to be considered, but health outcomes - all to no avail. Despite the fact that evidence demonstrates that more people died on low-salt diets than on high salt intakes, the AMA, NIH, AHA and NHLBI all continued to keep their heads buried in risk factors. It's unlikely that this article by Krumholz and Lee in the NEJM will get them to lift up their heads and see the light.
However, it's good to see that the number of enlightened keep growing.
