Surgery Decisions Shouldn’t Be Larded With Conflicts of Interest

The health and medicine watchdog recently laid bare how regulatory absence can poison what’s supposed to be an objective, scientific analysis of the suitability of a surgical procedure.

In excerpting an article that has been accepted for future publication in Arthritis Care & Research, HealthNewsReview shows the wide cracks in how the FDA approves some medical devices. Known as the 510(k) expedited review process, the exercise allows certain devices to be approved for sale “without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device.”

We’ve examined how devices are approved by the FDA, and how nonsensical the 510(k) process can be. On its face, an expedited process has merit. Many people otherwise without treatment for their medical problems can receive relief faster when bureaucracy gets out of the way. But speed doesn’t always result in good medicine.

As the journal article points out, a “previously approved” device might have been approved under 510(k), “leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

And lax regulation invites conflicts of interest. Using a hypothetical example, the writers demonstrate how, because surgeons have few constraints on their choice of medical device, “many are able to decide for themselves when they wish to begin using newer models.”

In the authors’ scenario, a surgeon, Dr. Jones, reviews a total hip replacement procedure with the patient, a man in his 50s. Dr. Jones makes sure he understands his options, and the patient signs the surgical consent form. Everything seems kosher but, although the risks and benefits of total hip replacement were detailed, shouldn’t the patient have participated in the decision about which implant device to use?

The authors say that without regulatory demand, not all the evidence must be presented that would fully inform the patient about technical considerations and the surgeon’s personal beliefs and possible conflicts of interest.

What if Dr. Jones has received consulting fees from the manufacturer of one of the devices under consideration? As the authors note, “Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

Doesn’t the patient deserve to know that?

Doctors with financial interests in medical devices aren’t limited to orthopedics-the industry is rife with cross-pollination of science and commerce in all manner of devices and drugs. Among the most active players are pharmaceutical manufacturers and the doctors they pay for research, consulting, speaking, travel and entertainment to (see our post).

Patients can’t make a fully informed decision about surgery unless they’re offered a clear, complete picture of all aspects of the procedure. To that end, the article authors suggest that for their hypothetical hip-replacement, “the informed consent process … be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values.”

Yes, it’s challenging. But it’s necessary and only fair, for this and any surgical procedure.

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