It is time for independent evaluation of healthcare outcomes

There has been much fanfare lately about a “new” technique that “cures” erectile dysfunction after surgery for prostate cancer. At a recent local press conference, a doctor who should know better claimed that applying the amniotic membrane from a human placenta around the neurovascular bundles in the pelvic cavity spurred early and robust recovery of sexual function in 10 men whose prostate gland was removed.

Two of these men shared their delight in a YouTube video, which unfortunately has prompted a number of inquiries to the University of Miami’s Department of Urology from patients seeking the estimated $2,000 treatment. It’s unfortunate because the video proved nothing but the need to warn the public in general, and men with prostate cancer and their families in particular, not to be duped by claims that have not one shred of scientific evidence behind them. It also reinforced the need to implement independent, accountable, third-party evaluations of health care outcomes.

As most surgeons who treat prostate cancer can attest, younger men often experience spontaneous post-surgery erections shortly after a prostatectomy, which is the removal of part or all of the prostate gland. As such, no one can unequivocally attribute early return of sexual function in two relatively young men to any technique because it could easily have been achieved without it.

Academia and the pharmaceutical and biotech industries spend countless hours and resources to conduct peer-reviewed scientific pre-clinical and clinical studies and trials to assure the safety and efficacy of new drugs and devices. Since there is no evidence any of that was done in this case, we know nothing about the short- or long-term consequences of inserting biologic tissue from an unrelated human in the pelvic cavity.

Yet, as the calls to our doctors attest, the unconfirmed experience of 10 men — and the ludicrous claims that prostatectomies cure prostate cancer and preserve urinary continence 99 percent of the time, and preserve sexual function 90 percent of the time — are raising unrealistic expectations for some of the nearly 250,000 men who face treatment choices for prostate cancer every year. Undoubtedly, this also will contribute to the medical and technology race that compels providers to line up to offer untested but expensive and potentially harmful treatment options.

About 90,000 prostatectomies will be performed in the United States this year for prostate cancer. If just half these patients received the “new” treatment, our nation would spend $90 million on an untested procedure that could result in more harm than good.

Unfortunately, this is just another example of a much broader problem of clever marketing trumping sound science, and steeply increasing the healthcare cost curve. Financial incentives drive human behavior and, in this increasingly competitive healthcare arena, providers and hospitals may be motivated to make unverified and grandiose claims of the latest, best and most optimal procedures to attract patients.

We do not accept this practice in almost any other realm of risk. Even the roller coaster we allow our children to ride at a theme park must be certified as safe by an independent third party. Yet the processes to ensure independence, reliability and accuracy of reported outcomes in healthcare are limited. Outside of industry and academia, which conduct large and important clinical trials under the auspices of independent data safety and monitoring committees, most reported outcomes have no independent, unbiased monitoring.

If we are to enable patients to make informed health care decisions and to compensate providers based on outcomes, as envisioned by the Patient Protection and Affordable Care Act, we must welcome independent, but accountable, third party evaluation of healthcare outcomes. The significant expense associated with marketing untested procedures and protocols would be far better used administering honest reporting.

People’s lives depend on that, and until we achieve this objective, the rule of thumb about unverified healthcare claims must be, “If it sounds too good to be true, it is not true.”

Dr. Dipen J. Parekh is chairman of the Department of Urology, University of Miami Miller School of Medicine.