COMMENTARY

When Patients Request Unproven Treatments

Stem Cell Injections in High Demand for Osteoarthritis

Casey J. Humbyrd, MD; Matthew K. Wynia, MD, MPH

Disclosures

March 25, 2019

A young man recently came to my office seeking a fifth opinion. He knew his diagnosis—arthritis—and what traditional treatment options were available. But he wanted more than what those treatments could provide: He wanted to turn back time.

The patient asked for my opinion on a treatment he had already been offered by another physician that promised to do just that: stem cell injections.

These treatments have been in the news lately. The US Food and Drug Administration (FDA) has been shutting down stem cell clinics in which patients have been injected with unapproved formulations, including a mixture from smallpox vaccines.

My patient wasn't interested in this type of treatment, however. He wanted to know what I thought about a procedure in which he would have his own bone marrow aspirated and the stem cells separated from the marrow and injected into his joint. It was pitched to him as an outpatient procedure that would completely solve his joint pain. He had come to me for another opinion because the procedure sounded almost too good to be true, except for the price running into thousands of dollars.

My patient believed that if such injections are regulated by the FDA, as some news stories have suggested, then they must be effective. He just wanted to know whether there were risks that the other clinic hadn't mentioned.

What he didn't know, as most people don't, is that stem cells harvested from a patient and then re-injected with minimal manipulation are regulated by section 361 of the Public Health Service Act, which only authorizes the FDA to regulate tissues to prevent the introduction, transmission, or spread of communicable diseases—that's all.

So section 361 requires good tissue handling practices, but it says nothing about any studies demonstrating efficacy.

In reality, far from being proven effective, stem cell injections have shown mixed results in the treatment of arthritis,[1,2] and at present, there is considerably more hype (and profit) than evidence around this treatment method. So the question is: If a patient wants to try such a treatment, given the state of the evidence, is it ethical for physicians to provide it?

Ethicists have made a variety of arguments about these injections. The primary arguments against them have focused on the perils of physicians becoming sellers of "snake oil," promising outlandish benefits and charging huge sums for treatments that might not work. The conflict of interest inherent in making money by providing an unproven therapy is a legitimate ethical concern. These treatments are very expensive and, as they are unproven, are rarely covered by insurance. As a result, some patients have turned to crowdfunding sites to pay for these questionable treatments.[3]

But the profit motive may not be the most important ethical issue at stake. If it were removed, hypothetically, and physicians provided the injections at cost, would that make this practice more acceptable?

No. We believe that physicians who offer these injections are skipping the most important step in the ethical adoption of any new treatment modality: research that clarifies the benefits and risks. The costs of omitting that important step are much more than just monetary.

For the sake of argument, let's assume that stem cells are tremendously successful and that they heal arthritic joints, making them as good as new. By selling these injections to those who can pay before the treatment is backed by research, physicians are ensuring unavailability to patients who can't pay, because insurance won't cover unproven treatments.

The gold standard for evaluating any new treatment is an adequately sized, randomized controlled trial in which the new treatment is compared with existing options or against a placebo. To date, there have been no such trials,[4] despite the fact that many thousands of people are lining up to get these treatments. Neglecting to do good research on an unproven treatment is the real ethical issue.

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