Panaceia or Hygeia

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Posts Tagged ‘King Pharmaceuticals’

Drug Marketing by Acronym. ACCORD and the Power of Myth

Posted by Colin Rose on July 14, 2008

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.

Legal Addictions

The ACCORD-type subject

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?

Posted in atherosclerosis, coronary artery disease, diabetes, Type 2, diet, drugs, obesity, professionalism | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

COURAGE demolishes the myth of the “widow maker” and the “time bomb” but does not use optimal medical therapy

Posted by Colin Rose on March 26, 2007

For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.


Legal Addictions

The COURAGE type subject

All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.

If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.




Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.

Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.

Posted in angioplasty, atherosclerosis, coronary artery disease, diet, drugs, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »


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