As drugs and procedures proliferate, comparative effectiveness research has become an essential tool for figuring out which medical treatments work best.
This research pits accepted treatment options against each other — one drug versus another, for example, or drugs versus surgery — to see which is safer and more effective.
But two prominent Kansas City physicians say the government could be jeopardizing this valuable research.
It all started with a controversial study that divided the nation’s medical community. The study in question tried to gauge how much supplemental oxygen a premature infant should receive.
It was long-known that given too little, a baby could die; too much and it could go blind. There was an established range of acceptable levels, but researchers wanted to know if outcomes were better at the higher or lower ends of the range. So preemies at major hospitals were randomly chosen to receive different amounts of oxygen. Ultimately, the study found that babies who got higher amounts were more likely to suffer eye damage, but also were less likely to die.
The study ignited a furor last year, with many ethicists and physicians and the Health and Human Services Office of Human Research Protections saying researchers broke the rules by not advising parents of reasonably foreseeable risks to their babies. An equally large group of experts said the study was within bounds because all the babies received an accepted level of care.
In October, HHS responded with proposed new guidelines for disclosing potential risks to patients in comparative effectiveness studies. Basically, it said patients should be advised of the risks of all the treatments under study. That’s because even though the risks wouldn’t be any different than they would be outside of the study, study patients may not get the same treatments as they would have outside the study.
To Children’s Mercy Hospital ethicist John Lantos and St. Luke’s Hospital heart researcher John Spertus, that is a radical shift in HHS policy. In a recent New England Journal of Medicine article they argue that the proposed guidelines would misinform patients into thinking that their personal doctor’s preferred treatment is always the safest and most effective.
“The net result,” they wrote, will “make research seem riskier than it truly is and make existing practices seem safer than they truly are...People will probably refuse to participate in research out of the false belief that, by refusing, they are avoiding risk.”
In other words, people will choose feeling safer over the chance to be safer.