In a new study geriatricians chastise drug developers for their persistent neglect in recruiting elderly patients for experimental heart drug trials. A team of investigators analyzed 251 trials and concluded that 43 percent of them had excluded anyone 65 and older without proper justification, reports Reuters.
The researchers found that a quarter of all studies simply redlined anyone older based on age guidelines for patient recruitment. Other studies, they added, indirectly excluded older patients with rules against including anyone who was taking other medications or suffered from co-morbidities--a common characteristic of older patients.
"It has been more than twenty years since regulatory agencies have been trying to include more older people in clinical trials, but the situation doesn't seem to be changing much," Dr. Antonio Cherubini told Reuters Health. And as a result, it's the older patients who need these drugs the most who suffer from an absence of data.
That may be, but Reuters failed to get the trial researchers' perspective on the way recruitment is skewed. A patient population which included subjects taking other drugs would greatly increase the chances of blurring the response data needed to see if the experimental drug is working as planned. And anyone suffering from co-morbidities would likewise confuse the data, greatly impeding any chances of success. The better question may be why more of these drugs aren't tested in head-to-head studies with competing therapies following an initial approval, with an eye on an older group of patients.
- here's the story from Reuters