Until Paula Span wrote about it in The New York Times‘ current New Old Age, I never thought about clinical trials & the elderly.
It turns out that a shocking number of clinical trials exclude people who are 70+. Good thing I’ve got three more years; my John, at 72, is out of luck. Seems that even studies of conditions that primarily affect the middle- & old-old don’t actually include the elderly as clinical trial subjects. Seriously?!
In all the years that John & I went with our mothers to doctor’s appointments, it never dawned on either of us that their geriatricians were left at times to make the best guess of how a medication or treatment might affect them. Keenly remember one heart specialist blaming Mom’s body for her adverse response to a medication rather that the medication or the dosage – now it makes sense.
Imagine the risks for an 83-year-old of a surgical procedure, drug or medical device never actually tested on anyone over 69 – YIKES! When drug & medical device trails routinely leave out the effect on folks 70+, ones who might have multiple health problems & take numerous med, olders elders ancients are left in a serious medical bind.
Praise be, the National Institutes of Health is issuing new policy guidelines for research funded under the NIH. As of 01/01/19, grant applicants will have to include either how they will include people of all ages (from children to elders) ~or~ provide “acceptable justifications for any group they leave out.” The NIH won’t just take their word for it – studies will be monitored to ensure compliance. As much a win for toddlers tweens teens as for olders, since they also are routinely prescribed drugs that were only tested on people 20-69!
The “wait, but” is that the guidelines do NOT affect privately funded research. Clearly a problem that needs more attention. Boomers should be rising up in protest for both themselves & their grandkids!
And they don’t take into consideration how their impact on people with multiple health problems, limited life expectancy or dementia & other cognitive impairment – people routinely shut out from clinical trials.
According to Paula, “Maddeningly, exclusion rates remain high even for studies of diseases particularly common at older ages. Dr. Bourgeois and her colleagues looked at clinical trials for heart disease medications, for instance — primarily blood thinners, cholesterol and blood pressure drugs. More than half of the trials had upper age limits, usually 75 or 80, and only about 12 percent of participants were aged 75 or older. Yet nearly 40 percent of people hospitalized with heart attacks are over age 75.”
Can they be more myopic?
Sure – consider the clinical trial that evaluated treatments for arthritic knees, a problem that primarily hits folks in their 70s & 80s. What was the average age of participants? 58!
It all makes sense if we shift our focus from the end benefit to the dynamics of the studies – the companies or organizations understand that they are going to be able to demonstrate the viability & effectiveness of A drug if it is used with participants who aren’t using other drugs, medications that might complicate their findings BUT which are common to the intended end users.
Remembering that the goal, especially for a company, is to get FDA approval or a drug or treatment, it’s way easier to for youngers to cleanly metabolize medications than olders.
What we’re left with are recommended medications that often kept olders elder ancients OUT of the studies that define efficacy – efficacious AS LONG as they are 69 or younger AND don’’t have health issues that might contraindicate the medication. As for olders, teens & young’uns metabolizing meds differently than those in the target group… tough noogies.
Paula says the heavy weight in getting all ages included in medical trails could be the Food & Drug Administration, if the FDA were given power to require that clinical trails for new drugs & medical devices include a full spectrum of ages. Realistically speaking, the possibility of this dream scenario happening is slim to none – handing the FDA that authority would require Congressional authorization & the long arm of a variety of heavy hitting lobbyists would stop it in its track. It’s a joke in the current political climate, where corporations have the same rights as citizens & elected officials seem more invested in their financial health than in their constituents’ actual health health.
We can but hope, but as I age upward toward 70, am not holding my breath.