Lack Of Diversity In Clinical Trials Can Kill
Make a commentBy Ed Silverman // November 18th, 2007 // 2:23 pm
Many studies document health care disparities - the lamentable failures of the medical establishment to deliver the best available care to women, minorities and other groups, writes The Baltimore Sun. But there is a flip side: When it comes to brand-new drugs and devices, it’s sometimes good to be left out. That’s because therapies that perform well in clinical trials often prove less effective - and sometimes more dangerous - when put to widespread use. The Sun goes on to cite implantable cardiac defibrillators, Vioxx, OTC meds for kids and drug-eluting stents as examples.
“When a problem occurs rarely, and you do the study in a couple of hundred people, you’re not going to see the problems until later,” Richard Lange, a professor of cardiology at the Johns Hopkins School of Medicine, tells the Sun. One reason, critics say, is another type of disparity: a lack of diversity in early clinical trials, which tend to enroll relatively healthy white males but few children, women, minorities and older patients.
As a result, the research ignores biological differences that cause people of varying ages, genders and ethnicities to react differently to the therapies. “We are extrapolating from a clinical-trial population that looks nothing like the general population,” Rita Redberg, a cardiologist at the University of California, San Francisco, tells the paper.
Why are there so few women and minorities in clinical trials? Experts said the reasons are complex. Women in their childbearing years may be absent because of concerns about the effects of a treatment on a developing fetus. And African-Americans tend to be generally more distrustful of the medical establishment than other groups - the long-term fallout from incidents like the Tuskegee study, a 40-year experiment begun in 1932 in which researchers withheld syphilis treatment from black farmers.
Older patients are often excluded because they may suffer from a number of age-related conditions that might complicate the research. This, in turn, may result in fewer female participants, since women tend to be older than men when they develop certain illnesses. Lange says the lack of diversity in studies puts the FDA, Medicare and private insurers in the difficult position of using narrowly focused data to decide which drugs will be used in a broad population of patients.
But the alternative - only offering treatment to white males - is equally undesirable, he says. “You can imagine the outcry,” Lange tells the Sun, “if Medicare said we’re not going to give drugs to women and minorities because we don’t have the data.”
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