CHRISTMAS, COURAGE, DIAMOND, DREAM, ILLUMINATE, ILLUSTRATE, REACH, PARAGON, PRAISE, PREVENT, ONTARGET, PROVE IT, ENHANCE, ACT, BEST, ADVANCE, HOPE, LIFE, PROSPER, CALIPSO, ASTEROID, ACCORD, CASHMERE, MIRACL, SYMPHONY, all names of recent drug studies that are carefully constructed pseudo acronyms invented by highly-paid marketers, implying that the drug studied has wonderful properties to prolong your life make it much more pleasant and worry-free. The marketers have learned that the name of the trial is more important than the results of the trial. Who would be attracted to older trials named WOSCOPS or LRC-CPPT? Would it really matter what the results of DREAM were? The acronyms imply that regardless of the result of the study the drug must be good for something. If one fiddles the statistics one can always find a sub-group in which the drug had some effect. You will never see a drug trials with the acronyms, DISEASE or DEATH but many of them do result in more of either of both.
To take one example, just the association of a drug with a trial like ACCORD (Action to COntrol Cardiovascular Risk in Diabetes) will give it cachet. But the results of the drug “action” in ACCORD was that adding more expensive drugs to the usual cocktail to markedly lower blood glucose to an arbitrary “target” in type 2 diabetics with known vascular disease caused more deaths than not meeting the “target”. The latest expensive drugs for DM2 were supplied by the usual suspects: Abbot Laboratories, Amylin, AstraZeneca, Bayer Healthcare, GlaxoSmithKline, King Pharmaceuticals, Merck, Novartis, Sanofi-Avenis, Schering-Plough. Seven of the lead authors have received drug money from multiple companies. But will the results of this study made a dent in the sales of the latest heavily-marketed, expensive drugs like Diamicron, Prandase (Precose), Amaryl, Avandia (Actos), and Byetta? Not likely. As an apologist for the drug industry who receives money from Amylin and Merck, stated in an editorial in the New England Journal of Medicine, this study “…[does] not provide a definitive answer to the problem of glycemic control and cardiovascular disease. Other ongoing clinical trials will provide additional clarification.” More dead people when taking more drugs is not clear? One of the studies we are to await is, wait for it, ORIGIN. Reminds one of the Garden of Eden. So, the myth of the necessity to “normalize” symptoms or metabolic self-abuse that might even be protective will persist and these unproven drugs will continue to be prescribed for many more years costing the medical systems of the world many $billions and making huge profits for their makers, in spite of the total absence of proof that anyone is better off or living longer swallowing these drugs.
These drugs were approved for sale purely on basis of their ability to lower blood glucose, a symptom of a self-abusive, atherogenic lifestyle. Look at the baseline characteristics of participants in ACCORD. Average BMI was 32. Obese is defined as BMI greater than 30. So almost all participants were obese. Is it not unethical to perform a drug study in such a group before they have all reduced their BMIs to under 25? Normalizing their weights, by far the most important “action”, would probably cure the diabetes in many of them and they wouldn’t even be in a study on diabetes. But one cannot sell drugs to healthy people. So why would any investigator receiving money from drug dealers insist that people with self-abusive lifestyles change their lifestyles before doing a drug trial? After all, no investigator wants to risk dying of old age before he or she can collect enough “events” (i.e. deaths) to write a paper whatever the conclusion might be.
Results from ACCORD. More deaths on “intensive” (more expensive drugs) therapy
Drs Krumholz and Lee, both with no ties to drug dealers write in a Perspective article in the same issue of the NEJM. “Clearly the way in which risk factors [blood cholesterol, blood glucose, high blood pressure] are modified does matter. Lifestyle interventions may [sic] have few risks, but we cannot assume the same for drugs…” “…ultimately we need to understand a strategy’s effects on people, not just on surrogate end points.” But even they refuse to recognize the absolute need for lifestyle change before starting drugs in patients with diseases of lifestyle. What risks could lifestyle change possibly have?