In 2002, San Francisco voters approved the ‘Care Not Cash’ measure, which aimed to reduce handing cash to homeless individuals based on the belief that funds would be wasted on substances. At the time, an opposite approach was occurring in research, with people using drugs being paid to participate in studies. Contrary to common belief, these payments were not fueling relapse. Research found that most money went towards essential expenses like rent, food, and bills, rather than drugs.
New medical treatments rely on trials involving participants who can dedicate time and resources. Studies testing combinations like buprenorphine and naloxone, known as Suboxone, involved active heroin users. Recently, the federal government revisited the need for such payments through the HHS Office of Inspector General, with public opinions solicited until August 24.
For years, legal uncertainties surrounded payments to trial participants due to anti-kickback statutes regarding Medicare and Medicaid patients. Concerns included the appearance of inducement to use reimbursable services, even for routine costs. Bioethics debates also suggested payments could influence vulnerable individuals’ choices. Testing among drug users indicated payments did not increase drug consumption or create coercion. Randomized studies showed improved follow-up without skewing participant demographics.
Payment could even enhance attention to risks in trials, with larger payments indicating seriousness. A 2021 study embedded random cash incentives in trials, which boosted enrollment in one trial but had no effect on the other. Neither affected participants’ risk assessment or participant demographics.
Treatments effective for specific populations must include trials with those individuals. Suboxone exists due to research involving active opioid users, who weren’t excluded for perceived compromise. Paying those least able to afford it prevents putting research costs on individuals needing these solutions. Current rules aim to prevent exploitation from excessive payments but risk exploiting participants by underpaying or excluding them.
Proposed measures include reimbursing real expenses, aligning with the 2018 FDA clarification that travel and lodging support does not pose undue-influence concerns. Compensation for participants’ time should be evaluated by institutional review boards without strict caps, which could limit study protocols or exclude crucial participants. Protections should encompass both government and wider research efforts handled by academics and industry.
‘Care Not Cash’ assumed some individuals can’t responsibly manage funds, yet clinical trials showed otherwise, demonstrating their vital role in proving treatments like Suboxone. Welfare and research roles differ; trial participation entails responsibility, protocol adherence, and sometimes risks. Medicaid encompasses its work requirements, and contributing to research should count towards them.
The inspector general can reshape rules to reflect evidence rather than outdated fears. Recognizing participants’ contribution to vital research offers a path forward.
Matthew Baggott, PhD, is a neuroscientist and CEO of Tactogen Inc. John Mendelson, MD, a board-certified internist renowned for over three decades in addiction treatment, serves as Chief Medical Officer and Founder of Ria Health.
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