Matt Lauer featured his own urologist, Dr. David Samadi. That’s a conflict of interest – for both Lauer and Samadi.
Samadi runs a robotic surgery center that thrives on doing robotic prostatectomies. That’s a conflict of interest. (Coincidentally, the Wall Street Journal last week reported, “Report Raises Concerns On Robotic Surgery.“ One of the authors of a draft analysis by researchers at Rush University Medical Center, the University of Illinois and MIT said, “We found that the rate of injury and death adverse events has actually gone up. That’s the most striking thing.”
Roker asked Samadi: “Are there any downsides to this? Any complications to screening?” Samadi responded: “There are no complications to screening. What we want people to know is, get your PSA baseline at the age of 40.”
Harms of Detection and Early Treatment/Harms Related to Screening and Diagnostic Procedures – Convincing evidence demonstrates that the PSA test often produces false-positive results (approximately 80% of positive PSA test results are false-positive when cutoffs between 2.5 and 4.0 μg/L are used). There is adequate evidence that false-positive PSA test results are associated with negative psychological effects, including persistent worry about prostate cancer. Men who have a false-positive test result are more likely to have additional testing, including 1 or more biopsies, in the following year than those who have a negative test result. Over 10 years, approximately 15% to 20% of men will have a PSA test result that triggers a biopsy, depending on the PSA threshold and testing interval used. New evidence from a randomized trial of treatment of screen-detected cancer indicates that roughly one third of men who have prostate biopsy experience pain, fever, bleeding, infection, transient urinary difficulties, or other issues requiring clinician follow-up that the men consider a “moderate or major problem”; approximately 1% require hospitalization/The USPSTF considered the magnitude of these harms associated with screening and diagnostic procedures to be at least small.Harms Related to Treatment of Screen-Detected CancerAdequate evidence shows that nearly 90% of men with PSA-detected prostate cancer in the United States have early treatment with surgery, radiation, or androgen deprivation therapy. Adequate evidence shows that up to 5 in 1000 men will die within 1 month of prostate cancer surgery and between 10 and 70 men will have serious complications but survive. Radiotherapy and surgery result in long-term adverse effects, including urinary incontinence and erectile dysfunction in at least 200 to 300 of 1000 men treated with these therapies. Radiotherapy is also associated with bowel dysfunction.Some clinicians have used androgen deprivation therapy as primary therapy for early-stage prostate cancer, particularly in older men, although this is not a U.S. Food and Drug Administration (FDA)–approved indication and it has not been shown to improve survival in localized prostate cancer. Adequate evidence shows that androgen deprivation therapy for localized prostate cancer is associated with erectile dysfunction (in approximately 400 of 1000 men treated), as well as gynecomastia and hot flashes.There is convincing evidence that PSA-based screening leads to substantial overdiagnosis of prostate tumors. The amount of overdiagnosis of prostate cancer is of important concern because a man with cancer that would remain asymptomatic for the remainder of his life cannot benefit from screening or treatment. There is a high propensity for physicians and patients to elect to treat most cases of screen-detected cancer, given our current inability to distinguish tumors that will remain indolent from those destined to be lethal. Thus, many men are being subjected to the harms of treatment of prostate cancer that will never become symptomatic. Even for men whose screen-detected cancer would otherwise have been later identified without screening, most experience the same outcome and are, therefore, subjected to the harms of treatment for a much longer period of time. There is convincing evidence that PSA-based screening for prostate cancer results in considerable overtreatment and its associated harms.The USPSTF considered the magnitude of these treatment-associated harms to be at least moderate.
Samadi said: “We’re going to save a lot of men” by promoting the Lauer and Roker digital rectal examinations (DRE). Really?
Dr. Richard Hoffman, one of our medical editors, wrote in another venue: “DRE can detect tumors in the posterior and lateral aspects of the prostate gland; an inherent limitation to the digital examination is that only 85 percent of cancers arise peripherally where they can be detected with a finger examination ..No controlled studies have shown a reduction in the morbidity or mortality of prostate cancer when detected by DRE at any age.”
So I asked Dr. Hoffman to review this Today show segment. He wrote to me:
“It’s like a Time Warp….(Rocky Horror Prostate Show?)….The recommendation for the baseline PSA test at age 40, the reliance on PSA velocity, the use of empiric antibiotic treatment for men with elevated PSA levels have all been rejected by recent guidelines issued by organizations as diverse as the American Cancer Society (ACS), the American College of Physicians, and the American Urological Association (AUA). Although Matt and Al received props from viewers for undergoing the digital rectal examination, they were probably unaware that the ACS and AUA both consider the DRE to be an optional exam–there is no evidence that undergoing a DRE will save lives. Dr. Samadi’s promise (threat?) to monitor Al every 6 months for his enlarged prostate is also not supported by guidelines–even the AUA recognizes that screening every 2 years is sufficient.The assertions that screening will save many lives and that there are no complications to screening are also misleading. At best, screening with PSA will save 1 in a 1000 screened men from dying from prostate cancer after 11 years. While blood tests and DRE have essentially no complications, the cascade of events set in motion by these screening tests does cause harm–from false positive tests, biopsy complications, overdiagnosis, overtreatment, and treatment complications. The American College of Physicians (ACP) nicely captured the issue in their guidance statement: ‘ACP recommends that clinicians inform men between the age of 50 and 69 years about the limited potential benefits and substantial harms of screening for prostate cancer. ACP recommends that clinicians base the decision to screen for prostate cancer using the prostate-specific antigen test on the risk for prostate cancer, a discussion of the benefits and harms of screening, the patient’s general health and life expectancy, and patient preferences.’ This nuanced message did not come across in the 4:40 infomercial.”
NBC News Chief Medical Editor Dr. Nancy Snyderman was present for all of this – including the giggling locker room humor between Dr. Samadi and his celebrity patients. But she did nothing to correct the record or to inject accurate, balanced and complete information in this prostate screening infomercial, as Dr. Hoffman called it.
“…this is the same Dr. Samadi who permitted himself to appear in a testimonial video produced by Intuitive Surgery (posted on August 28, 2013) to support its marketing campaign for use of the daVinci robotic surgery machine, specifically by playing on men’s fear of impotence and incontinence. His statement–”There’s a huge benefit to patients when they go through the daVinci prostate surgery”–is not supported by scientific inquiry.”
The American Cancer Society’s Director of Medical & Scientific Communications, David Sampson, tweeted about the Roker-Samadi exchange about complications: “Informed Consent FAIL.”
We have moved from Pinktober to Movember but we really haven’t moved forward much at all.
Please note: This is not an anti-screening message. It is a call for an accurate, balanced and complete discussion of the tradeoff between potential benefits and potential harms in mass screening promotions. NBC had plenty of airtime to do this. They made a conscious choice not to. It was a disservice. That is our focus.
This story describes a small, ongoing study that touted lidocaine delivered to the back of the nasal cavity as an effective treatment for migraines. Although the story notes that the findings are preliminary, it does not inform us that the study wasn’t randomized or placebo-controlled; these are major drawbacks in interpreting the effectiveness of the procedure.
This story improves upon other recent Fox News efforts by including an independent expert perspective — the lack of which we commented on in a blog post about Fox News last week. But while our star score reflects that improvement, we still don’t think this story contributes very much to the public dialogue about health care. Our concerns are detailed in the review.