Wednesday, September 7, 2011

Pharmaceutical trials - elderly often excluded

I wrote about this in my book, but 'Elderly Often Excluded From Clinical Trials'  speaks of the severe limitations of drug testing.
Pharmaceuticals determine which population they may exclude (seniors), and do not test those with comorbidities. Most of us are fighting more than one disease, rather than less. The drug trial results would be different on 45-year-olds than those over 70.

Morbidity rates of those undergoing surgery are clear, yet some surgeries are carried out. One must be proactive and ask the questions.


Clinical Trials Neglect the Elderly

In last month’s Journal of General Internal Medicine, a University of Michigan team pointed to some systemic problems. Analyzing more than 100 studies published during 2007 in prestigious medical journals, the researchers found that more than 20 percent excluded participants above a particular age. That actually represented considerable progress; a previous study of trials published from 1994 to 2006 found that 39 percent had excluded people over age 65.


More disturbingly, even when older people aren’t barred by age, they get left out for other reasons. More than 45 percent of the trials that didn’t have age limits excluded people for having other illnesses or cognitive impairment, for having a reduced life expectancy or physical disabilities or functional limitations, even for living in a nursing home or senior residence – all restrictions that tend to remove the elderly from the mix. Simply requiring study participants to show up at an office or clinic for regular monitoring may prevent frail elders or those who lack transportation from participating.


Clinical Trials Neglect the Elderly

The randomized clinical trial, long the gold standard of medical research, supposedly provides the most reliable data regarding which drugs, devices and procedures prove effective on real patients and which don’t. But when the people enrolled in the trial are quite different from those who will actually use the drug or device or undergo the procedure, the data are far less reliable.
In last month’s Journal of General Internal Medicine, a University of Michigan team pointed to some systemic problems. Analyzing more than 100 studies published during 2007 in prestigious medical journals, the researchers found that more than 20 percent excluded participants above a particular age. That actually represented considerable progress; a previous study of trials published from 1994 to 2006 found that 39 percent had excluded people over age 65.

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