Informed or Misinformed Consent?

In the September 8, 2015 edition of JAMA, an editorial was offered by Harald Schmidt, PhD, MA, calling into question “incentives” for mammographic screening. Writing from the Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Dr. Schmidt raises an interesting question – should we be giving away free T-shirts or movie tickets to reward patients for having their screening mammograms?

 

I share some discomfort about certain promotional activities. Over the years, I have been repeatedly approached to offer a “free mammogram” at health fairs and silent auctions for fund-raising events. Others in the community were doing it, so “why don’t you?” Well, a mammogram can generate a false-positive, with a requisite biopsy that can backfire if a borderline lesion is found that ends up being called “cancer,” and the next thing you know, bilateral mastectomy or radiation therapy is being performed. That’s why. I’ve never been comfortable with such flippancy when it comes to a screening mammogram. It is a two-edged sword.

 

But Dr. Schmidt takes his position further – calling into question media-awareness campaigns, e-mail or phone call reminders, and the concept of default mammogram orders with electronic medical records. In his argument, Dr. Schmidt endorses the recommendations of the U.S. Preventive Services Task Force to the degree of, oh, roughly 100%. And that’s where we part.

 

Anti-screeners are taking great delight in performing studies that show how women – when “truly informed” about the risks versus the limited benefits of mammography – will opt for less screening, or no screening at all. But what they call a “thorough informed consent,” I call baloney. The benefits of mammography in these consents are based on a technology that doesn’t even exist anymore. ALL the prospective, randomized controlled trials that the Task Force holds in such dear esteem were accomplished with film screen mammography during an era prior to quality assurance. Only the U.K.’s AGE trial made it into the 1990s with active screening. The other 8 prospective RCTs took place starting in the 1960s, peaking in the 70s and 80s. We are two generations past that now, and the only thing the Task Force can do is watch the tail end of progress pass them by as they pronounce “Insufficient Evidence” (as they recently did for 3-D tomosynthesis mammography). Because of their insistence on prospective RCTs (excluding all other evidence), no matter how absurd or antiquated the study, they were never able to endorse digital mammography. The technology came and went (or is leaving, at least, being replaced with 3-D tomosynthesis) while they awaited results from ethereal prospective RCTs that are never going to occur.

 

After grossly minimizing the benefits of screening, often based on “invitation to screen” rather than actual screening, the harms are greatly exaggerated (including lifetime psychological damage from a benign biopsy).   It is demoralizing to read the informed consents that are being laid on unsuspecting women where benefits are minimized and harms maximized. Dr. Schmidt emphasizes the very important need to make women aware of “overdiagnosis” with mammography. Fine. What number should we use, since the published range is from 0 to 50% in a debate that is highly contentious? If overdiagnosis is occurring at the same rate we see in prostate cancer, then explain how, at autopsy, over 50% of men will have occult prostate cancer undiagnosed and subclinical, while only 1% of women will die with an undiagnosed invasive breast cancer.

 

Grossly exaggerated overdiagnosis rates are just one example of how women are being frightened out of mammography. These are not informed consents – they are propaganda. Not a single life will be saved by this social tsunami, but you can readily calculate the number of deaths as women choose to back away from screening after their “misinformed consents.” 2,000 more breast cancer deaths per year is a fairly accurate number that will result if Task Force guidelines are followed rather than American Cancer Society (and all other professional societies that address breast cancer).

 

Yes, we have a resource allocation problem, and this is why some clinicians are drawn to the concept behind (or membership on) the Task Force. It’s hard to argue with the basic philosophy that the U.S. has been throwing money at diseases for many years without a proven advantage in many instances. Task Force members and their ilk, while claiming to be unbiased judges of quality care, are not immune from human bias. In this case, their bias is such that when it comes to spending money for preventive health measures, “We have to put a lid on it.”

 

The challenge is making sure that the Task Force is not talking about the lid to your coffin.

 

 

Advertisements