Both prescription and over-the-counter medications must undergo extensive testing and trials before being released to the public. But it now comes to light that many new drugs are rarely tested on the obese…
Obese overlooked?
There are many reasons that some new Drugs are never tested on the obese. And, on their faces, they seem reasonable. But some MDs are now asking whether this is putting obese people at risk.
“Clinical trials and dosing instructions don’t always ensure that drugs will be safe and effective for people with obesity,” Christina Chow, a drug researcher who’s reported on the challenges of considering obesity in drug development, told the Associated Press (AP). “There’s no real emphasis for them to be studied at all.”
Research shows that some common medications don’t work the same way in obese patient as they do in those of normal weight. These include, “…antibiotics and antifungal drugs used to treat serious infections, synthetic hormones used in ‘Plan B’ emergency contraception, and even ibuprofen, the common painkiller sold as Advil.’
Why exclude the obese?
One reason is simply that folks who volunteer for medical studies are overwhelmingly ‘averag. Which means average, or ‘normal’ weight. So the overweight and obese systematically exclude themselves from drug trials.
Study co-author Dr. Caroline Apovian, a researcher at Brigham and Women’s Hospital in Boston, also notes that many drug researchers worry that health complications associated with obesity will skew the results of their tests.
“Sometimes, patients with obesity have […] more comorbidities than [average-weight patients]. They’ll have more diabetes, more heart disease, more strokes,” she said.
In addition,some drugs are naturally sequestered in fatty tissues and don’t get into the patient’s system. Thus, a dosing issue arises.
And drugs generally remain in the systems of obese patients longer. That could result in harmful drug interactions of other, incompatible drugs are introduced too soon after the first one.
And that’s just the beginning.
‘Information deficit’
What has resulted from the exclusion of obese people from drug trials is what some researchers call an ‘information deficit’. That may result in physicians mis-prescribing medications for the obese, who may require more or less of a given drug achieve the desired therapeutic effects.
“It’s very hard to be a physician and say that I’m going to prescribe out of the normal range,” observed Dr. Colleen Tenan, a board member of the Association of Clinical Research Professionals.
Change is slow
But it’s coming. It’s mainly a matter of conscious inclusion of the obese in drug trials. And partly a matter of acceptance that their needs may be different than those of the ‘average’ patient.
According to the abstract, “FDA Commissioner Dr. Robert Califf [has] acknowledged a ‘deficit of evidence’ about how medicines act in patients who are obese. The NIH now encourages researchers to consider the impact of excluding obese people in their studies, a spokesperson said.”
My take
More than half of all Americans are now overweight or obese. And Canadians, Western Europeans, Mexicans and Urban South Americans are not far behind. That makes the need to include obese people in drug trials even more urgent.
If we can’t convince the obese to lose weight and rejoin the ‘average’ patient pool, the medical and drug research communities have a moral and ethical obligation to make sure they’re getting the right doses of the right medicatio0ns.
~ Maggie J.