HHS should protect payments to clinical trial participants

In 2002, San Francisco voters passed the “Care Not Cash” measure, built on a simple intuition: Stop handing cash to homeless people, because they will only waste it on drugs and alcohol.

By then, we were a decade into doing the opposite — paying people who used drugs, often hundreds of dollars at a time, to take part in research. The conventional wisdom said we were funding relapse, but it was wrong. When researchers have looked, the bulk of the money goes to rent, food, and bills, not drugs.

New treatments get developed only when the people who need them can afford the time, travel, and support to take part. The studies we were working to complete tested the buprenorphine and naloxone combination now sold as Suboxone, in people actively using heroin.

The federal government is now asking the same question we spent years answering. As part of a broader effort to support American clinical research, the HHS Office of Inspector General has opened a formal request for comment on whether to protect payments to clinical trial participants, with comments due Aug. 24.

For decades, those payments have sat in a legal gray zone, created by an anti-kickback statute and a related rule that penalizes offering inducements to Medicare and Medicaid patients. The worry is that reimbursing a federal beneficiary’s costs can look like an inducement to use reimbursable services, even when those costs would have been incurred in routine care anyway. The bioethics worry is that money could corrupt the choices of vulnerable people.

That bioethics concern has been tested in people who use........

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