A recent article highlighted some of the reasons why low-income people without health insurance are being excluded from the potential benefits of clinical trials (see: Living With Cancer: The Cost of Trials). Below is an excerpt from it. written first-hand by a cancer patient:
A recent CT scan made me realize that the clinical trial extending my life effectively excludes all but the most privileged cancer patients...My oncologist and I had agreed to fudge on frequent testing. But the clinical trial did not. When I registered for the CT, a woman wearing a badge that read “financial navigator” handed me the requisite forms to sign. I explained that the CT should be billed to the Phase I trial, since I was undergoing it so the investigators could measure the efficacy of their drug. Unable to reach the trial administrator by phone, she asked, “Can we put it down as a self-pay since you can change it afterwards?”....The nausea I had felt that day returned some time later when I received a bill for $4,567. Because standard practice of care for recurrent ovarian cancer includes a CT every three months, the trial did not cover the cost of this scan. At registration, I had been thinking in terms of the trial paying or me paying. Instead of saying “self-pay,” I should have handed the “financial navigator” my insurance cards. Adjustments would have to be made with billing services. My mistake at registration revealed the exorbitant price of the CT, which otherwise would have been masked by the incomprehensible maze of paperwork sent by providers. The trial exacts large expenses: it requires that people have periodic scans and does not pay for them. How could patients who are under-insured or not insured at all be included in such a clinical trial? How could people working for the minimum wage afford $18,268 a year for CTs? ....Now I understand why low-income patients are underrepresented in cancer trials, although they bear a disproportionate burden of cancer mortality. For economic status is of course a barrier not only to trials but also, more alarmingly, to detection and treatment.
In a previous note about clinical trials, I reported that the Affordable Care Act (ACA) prohibits health insurance companies from denying their policy holders access to such trials for reasons of cost (see: The Accountable Care Act (ACA) and Clinical Trials). In the note, I also cautioned patients about enrolling in trials without an understanding of both additional expenses that might be incurred as a result of the trial protocol and also the potential benefits of participation. The excerpt above discusses some of the challenges of the payment "negotiations" that ensue for a cancer patient enrolled in a trial. She had health insurance which covered the cost of "standard" diagnostic tests and treatments whereas those extraordinary expenses attributable to the trial research protocol would be covered by the trial budget.
I don't have data to prove it, but I, and the author of the article above, believe that low-income, uninsured people with cancer would probably not be admitted to most clinical trials. Frequently, clinical trials relating to cancer therapy are the most sought after failures of standard therapy. Such patients could certainly not be able to pay an out-of-pocket cost of $4,567 for CT scans not covered by the clinical trial.
There are a number of problems that present themselves if low-income patients are underrepresented in clinical trials. First, most such trials are supported by federal money. Such benefits should be equally accessible. Secondly, lower-income individuals tend to be unhealthier with a higher prevalence of chronic diseases. This is related to factors such as income, access to care, and lifestyle choices. On the basis of such exclusion, the results of the clinical trials are biased toward healthier people who may have a different (i.e., better) response to the treatments being evaluated.
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