Recently on Facebook, I saw ad from an orthopaedic spine surgeon advertising an elective lumbar spine fusion surgery as part of a study. If patients enrolled and received the surgery, they would also receive $1,600.
The information provided on the ad linked a website which stated that the treatment is FDA-approved and they were “not testing unproven or experimental methods. Our study uses current FDA-cleared treatment and is intended to simply monitor the post-surgical process.” According to the company website, the standard spinal fusion was comparable to a 510k device. The ad was nothing more than a company-sponsored study designed for marketing purposes. Subsequent inquiries revealed that the physician was also receiving compensation for enrolling patients and participation in the study.
I had never seen an arrangement like this before. Over the years, I’ve referred several patients with brain cancer to clinical trials at tertiary care cancer centers, but I can’t remember any of those patients ever being financially compensated for their participation and at no time was I ever offered compensation for patient recruitment.
Conversations among my colleagues raised several questions regarding this issue. Is an ad and payment offer like this considered ethical or even legal behavior?
The federal government has clear wording regarding physician payments for research studies. The Anti-Kickback Statute is a federal criminal law that prohibits “knowing and willful” payments to “induce or reward patient referrals” or the generation of business. Kickbacks can include cash, free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. A kickback can be offered directly or indirectly through a third party such as a consultant or vendor. Any payment, reward, benefit, or compensation offered to a physician with the intent of influencing their medical judgment and decision-making is also considered a kickback.
The FDA also addresses ethics around payments in their published guidelines, this time on the patient side. In policy around compensation of patients for their participation in research studies, they write that besides “reasonable” travel and lodging expenses, review boards should be “sensitive” to whether the proposed payment presents an “undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent.”
What about the effect a cash payment to the patient would have on their decision to agree to elective spine surgery? It is difficult to conceive that a patient’s decision to have elective surgery could not be influenced by the offer of significant financial compensation.
In this specific situation, whether to offer surgery on the lumbar spine is a difficult and not an entirely data-driven decision. A good outcome from lumbar fusion surgery requires a surgically treatable condition and a well-motivated patient that has a strong desire to improve, recover, and restore their function. What does it say about a patient that responds to this type of ad posted on social media? The type of personality traits that we look for in patients to recover and do well should not include the type of patient that is motivated by financial compensation by agreeing to surgery. This patient may be a little too eager for surgery, perhaps not motivated to get well in the manner I’d expect.
What about the effect on the surgeon’s decision to recommend surgery? It is difficult to conceive that a surgeon’s decision to offer surgery could not be influenced by the offer of significant financial compensation by enrolling the patient in the study. This influence may be overt and conscious, or very easily could be covert and subconscious. As physicians, we are in a unique and sacred position to influence the decisions our patients make, especially when the decision is about elective surgery. Can a surgeon be trusted to put the best interests of the patient first when there is a financial incentive to push the patient toward a particular treatment?
Another interesting aspect of this situation is the issue of transparency. When physicians lecture or publish, it is ethically expected that relevant financial relationships and compensations are revealed to the audience. In situations like this one, should the physician disclose the fact that they are being financially compensated to the patient? Nothing mandates disclosure to the patient. If you were the patient, would revealing such information affect your decision-making when choosing a treatment option?
What about the effect the exchange of payments may have on the validity of the research being done? The study being conducted in this instance is done for device marketing purposes. Post marketing research is not novel, or groundbreaking, or cutting-edge scientific research. It is done to build colorful flashy graphs, printed on excessively large marketing materials that company reps litter my office with on a nonstop basis. They are low-powered, uncontrolled outcome studies. This study is at best considered level IV evidence and the data reported may have been affected by study participant payment and enrolling physician payment.
When recommending elective surgery to a patient, the physician must balance the risks of the elective procedure with the potential benefit of the procedure. Since the procedure is elective, the patient must also balance the risks and benefits when deciding whether to consent to the procedure. In situations such as this, it is impossible to reconcile a healthy physician-patient relationship and objective medical decision-making when there is extracurricular compensation for the both the patient and the physician. The issue of financial compensation should never be an issue for a patient deciding on the risks and benefits of an elective procedure. It almost goes without saying that the patient needs to be able to trust that their physician is not being influenced by potential financial compensation when making any treatment recommendations.
In the purest version of the doctor-patient relationship, financial compensation should never be an issue for either the patient or the physician. The reality is that medical care in America almost always involves money, therefore, the purest version of the doctor-patient relationship is a fantasy. That doesn’t mean that we shouldn’t strive to get as close to that ideal as possible.
What are your thoughts on payment for patient recruitment? Share your thoughts below.
Dr. Gruber is a neurosurgeon in Paducah, KY. His clinical interests include brain tumor management and robotic spine surgery. Find him on Twitter @DrThomasGruber and LinkedIn. Dr. Gruber is a 2022–2023 Doximity Op-Med Fellow.
Image by Denis Novikov / GettyImages