A newly available prostate cancer treatment has made Kaiser Permanente, one of the largest not-for-profit health plans, sit up and take notice. On October 4, 2016, the life sciences news service StatNews featured an article by Kaiser News staffer Julie Appleby, “Billboards and Websites Push Costly Prostate Cancer Treatment With Unknown Long-Term Benefits.”[i] The treatment in question is High Intensity Focused Ultrasound (HIFU), which was approved by the FDA in October 2015 after previous rejections. Ms. Appleby’s article does not question HIFU as such. Rather, her piece goes after the marketing and advertising tactics being used to promote it.
Billboards and ads promise that the treatment is noninvasive (true), that it is “a safer method” (safer than what? Robotic prostatectomy? Radiation?)with “no erectile dysfunction and no incontinence.” Oops. Published data shows a range of side effect rates depending on whether a patient has whole gland HIFU, half-gland HIFU (called hemiablation) or focal HIFU. There is no published data showing zero urinary and sexual side effects. Ms. Appleby implies that some of the ads amount to a come-on.
She writes, “Men hoping to avoid some of the dreaded side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a new procedure whose long-term effects are unknown…” An important criticism is leveled at the surge of ads as sales of $500,000 devices are surging: men who might well qualify for Active Surveillance are perhaps being drawn to spend $15-25,000 for a procedure they don’t need. Why would newly diagnosed men rapidly turn to HIFU? Because the ads imply cancer control with no side effects, yet long-term data is lacking. Why would the physician groups buying the equipment run expensive ads? I think the answer is obvious. How else will they pay for the technology?
Ms. Appleby points out that the billboards and ads raise “…concerns over whether there should be limits — such as requiring tracking of results — placed on expensive new technology while additional data is gathered.” Here’s the bind: If limits were placed on offering treatments while waiting for expensive, Level One randomized and controlled studies with 10 or more years of data, patients would be deprived of innovations for at least a decade. That means hundreds of thousands of over-diagnosed, over-treated patients while the clock slowly ticks. That means the mutilation of patients’ lifestyles while efforts to fund such costly studies stall due to lack of financial backing for enrollment and long-term follow up.
To avoid the inevitable outcry that would arise from patients who seek alternatives to prostatectomy and radiation, the FDA approvals are worded in a way to allow physicians to use good judgment and carefully discuss with patients what is known about the treatment, including cancer control and side effects. What is truly unacceptable, however, is a marketing/advertising push that may raise unrealistic hopes and expectations for vulnerable patients. It is this that Ms. Appleby protests in her article, and rightly so.
All of us, including the Sperling Prostate Center, must be careful to not overpromise or imply more than we can deliver. We echo Ms. Appleby’s concern that in the intention to help patients, those who are quickly getting on board with HIFU technology are not over promoting a new treatment before it has a justified track record.
[i] Appleby, Julie. StatNews, Oct. 4, 2016. https://www.statnews.com/2016/10/04/prostate-cancer-ultrasound-treatment/