March 4, 2004
By Linda Gorman
If evidence-based medicine becomes law in Colorado, your dog may have more influence on his medical treatment than you do on yours.
Under language floating around the statehouse, future Colorado law could appoint a small committee to use “evidence-based medicine” to “integrate” the clinical expertise of a “health care provider” with a “covered person’s choice of care” and “efficacious interventions to maximize the quality and quantity of life for individual covered persons.” At least those who decide on a dog’s fate usually know him and treat him as an individual.
Evidence-based medicine advocates want small committees to start dictating the treatments your doctor can provide. They distrust clinical observation, preferring information from randomized clinical trials (RCTs), experiments that rely on statistics to compare outcomes for groups of people receiving different treatments. David Sackett, an evidence-based medicine founder, went so far as to recommend that “If you find that [a] study was not randomized we’d suggest that you stop reading it and go on to the next article.”
Had Dr. Barry Marshall followed Sackett’s guidelines, millions of people would still have gastric ulcers. In 1979, Dr. J. Robin Warren noticed bacteria near irritated sections of tissue in stomach biopsies of ulcer patients. No such bacteria were present in biopsies of people without ulcers. He and Marshall began investigating the bacteria, and Marshall became convinced that it was a major cause of ulcers. Experts called the idea preposterous. In 1984, a frustrated Dr. Marshall drank a bacterial solution to prove that the bacteria could cause gastric disease.
Convinced that he was correct, Dr. Marshall began treating ulcers by attacking the bacteria. His patients improved dramatically. In 1985, Marshall started a randomized trial of 100 patients. In 1988 he submitted the results to the New England Journal of Medicine. The paper was rejected. Marshall kept on treating patients. In 1995 he received the Albert Lasker Award for Clinical Medical Research.
Had evidence-based clinical practice been law, Dr. Marshall could have been sued for deviating from “evidence-based” principles in treating his ulcer patients. But only by curing patients could he convince anyone to support a randomized trial.
In addition to retarding innovation, over-reliance on RCTs may increase inappropriate treatments. In December 2002, the National Heart, Lung, and Blood Institute (NHLBI) began an unprecedented effort to publicize the results of its $125 million ALLHAT trial. ALLHAT researchers claimed that the trial demonstrated that a cheap diuretic did as good a job of preventing heart attacks and fatal coronary artery disease as a more expensive ACE inhibitor. In May 2003, the NHLBI rushed the trial results into national “evidence-based” guidelines promoting diuretics as the initial drug of choice for treatment of high blood pressure.
Other experts took time to digest the ALLHAT results and expressed reservations about its findings. They noted that the study used primitive drug therapies, had a research design biased in favor of the diuretic, and did not achieve adequate blood pressure control in all groups. It also gave short shrift to the serious side effects diuretics have on organs other than the heart. Given that evidence-based medicine committees typically approve of ALLHAT, evidence-based clinical practice would likely require that patients with high blood pressure be put on a diuretic first despite the fact that diuretics appear to be associated with a 40 to 65 percent increase in new onset diabetes, a more rapid decline in kidney function, and an elevated risk of renal cell cancers. For Caucasian males, diuretics may increase all cause mortality relative to ACE inhibitors by as much as 11%.
The problem with evidence-based medicine is that its proponents want everyone to pretend that high-priced literature searches can substitute for the informed judgment that is the foundation of science-based medicine. Medical science is a messy social endeavor. It mixes observation, experiment, randomized controlled trials, and seemingly farfetched proposals into an ongoing conversation that takes place in medical journals, meetings, talks, informal conversations, and formal education. Over time, informed judgment, careful observation, repeated trials, elegant experiments, inelegant experiments, and pure serendipity combine to create the medical miracles we now take for granted.
Those medical miracles will keep coming as long as the Dr. Marshalls of medicine are free to treat patients as their conscience dictates, and free to act as the last line of defense for patients against government or private sector bureaucrats pushing flawed treatments for political or financial gain. Had law given evidence-based masters dominion over specialists in treating high blood pressure, the millions of Americans who don’t fit the ALLHAT profile would have been subjected to cheap treatments known to produce poorer outcomes. In short, when the law finally requires evidence-based medicine, you’ll know that medicine is going to the dogs.
The Independence Institute
14142 Denver West Parkway, Suite 185
Golden, CO 80401
INDEPENDENCE INSTITUTE is a non-profit, non-partisan Colorado think tank. It is governed by a statewide board of trustees and holds a 501(c)(3) tax exemption from the IRS. Its public policy research focuses on economic growth, education reform, local government effectiveness, and Constitutional rights.
JON CALDARA is the President of the Independence Institute.
LINDA GORMAN is a Senior Fellow at the Independence Institute.
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