By Robert Pearl, MD | Forbes.com | March 2, 2017
On a recent airplane flight, my attention was drawn to what my fellow travelers were reading. The man to my left was engrossed in an article from the Wall Street Journal titled, “A New Device May Mean Fewer Breast-Cancer Surgeries.” The woman to my right was reading a medical advice column in the Washington Post on a new type of hip joint implant manufactured using 3D printing. My curiosity was piqued—so much so that when I landed, I purchased each newspaper to see what I could learn about these apparent scientific breakthroughs.
What struck me was that neither medical device story presented convincing evidence that the product would make a real difference in outcomes for patients. Yet both medical devices were backed by investors with billion-dollar expectations. The applications were clever, but the promises made and the media coverage provided far surpassed what the research demonstrated.
The Hype Is Ahead of the Evidence
For decades, scientists have known that the rapid replication of cancer cells results in a different fat composition in their cell membranes than in normal cells. Using this information, researchers hypothesized that they could analyze the smoke given off by the cauterization process used to stop bleeding in the operating room and tell whether a tissue was cancer or not. To demonstrate the potential of this approach, they analyzed large cancer specimens, cauterized the tissue itself and, using a mass spectrometer, identified the differences between this smoke and that generated by normal tissue. Up to this point the science about these differences was solid, and the conclusions reasonable.
But the developers of the hand-held machine that would be used in the operating room to transport the smoke to the mass spectrometer went multiple steps further. They described for the lay press how using their device could reduce the amount of normal tissue resected during cancer ablation and therefore avoid the need to repeat surgery. And this leap, certain to appeal to the lay public and people with cancer, not only was misleading, but also doesn’t make medical sense.
When surgeons undertake a tumor resection, they strive to remove not only all of the malignant cells but also a margin of normal tissue. One reason is that small numbers of cells can invade the tissue and be left behind. Another reason is that some tumors spread through the lymphatic system and, as such, the margin could be tumor-free, but malignant cells could be located a short distance away in the lymph channels. By taking out additional tissue, surgeons hope to avoid local recurrence and prevent the spread of the cancer to the more distant local lymph nodes and, ultimately, other organs.
The “smoke print” created by cauterizing large blocks of cancer proved different from those created by the non-cancerous tissue. Demonstrating this was an essential first step, but no more than that. What needed to be shown was whether this approach would work when only a few cancer cells are left, and 99% of the margin is normal. And, even more importantly, whether removing these few additional cells would improve the outcome for patients or lower the incidence of recurrence when compared with current techniques. Neither of these questions were answered.
And yet the developers of this so-called “surgical knife” and the owners of the patent, rather than reporting their findings as a preliminary step in a long process of research, made their conclusions sound treatment-redefining and even implied that, in the near future, this device would be standard in operating rooms around the world. For this reason, they garnered headline coverage. In reality, this machine is unlikely to save a single life anytime soon.
A Better Opportunity to Prevent Death from Cancer
Promoting medical devices like this, long before their efficacy has been proven, is common. Similarly, new medications that extend life on average only a few weeks are touted on a regular basis to patients through advertising. In contrast to most of these new inventions and drugs, commonly available tests, if completed by all people at risk, could save tens of thousands more lives each year. For example, more than 50,000 people die annually from colon cancer—half of them unnecessarily. We have the tools to detect colon cancer at its earliest stages, and to treat precancerous polyps before they become malignant. For most people, detection can be accomplished without colonoscopy, and without having to undergo an extensive bowel prep or face the small risks associated with an invasive procedure.
Indeed, the fecal immunochemical test, or “FIT,” takes but five minutes once a year. It is self-administered in the comfort and privacy of a person’s bathroom with no prep, no pain and no risk. If done annually, according to the American Cancer Society, it detects cancer as frequently as an invasive procedure. Five minutes a year for 10 years comes to a total of 50 minutes, compared with missing two days of your life for colonoscopy and the associated discomfort of the prep itself. Yet the advantages of this approach rarely earn media attention even though, if followed by all Americans over the age of 50, doing so could save at least 25,000 lives a year.
Smoking deserves discussion in this context as well. It remains the leading cause of cancer in the United States, with the habit causing hundreds of thousands of deaths each year. For decades, we have recognized that smoking accounts for the overwhelming majority of lung cancers, as well as for increasing the risk of death from emphysema, chronic lung disease and heart disease.
But once again, the media tends to focus on the “sizzle” and not the “steak”—and thereby overlook what would save the most lives. The media could highlight the relatively high frequency of smoking (one in six Americans) and the significantly higher rates in states that still permit smoking in bars and restaurants, but it doesn’t. Instead, it prefers to highlight the newest products that glitter, even though they usually prove to be fool’s gold.
Our Brains Deceive Us
Multiple types of implants for hip and knee replacements are sold in the United States, but the differences in outcome among brands is minimal, if existent at all. For most patients, the implants already available produce excellent results. And in the rare event that standard devices are less than optimal, companies can manufacture custom-made ones. How the implants are created, whether through standard manufacturing techniques or 3D printing, is beside the point. And there are reasons to believe the traditional methods for making medical devices may be superior compared to 3D printing when it comes to metal implants. But because people tend to associate 3D printing with space-age technology, they conclude that devices created through this new technology are better.
The source of the problem, in essence, is how we think and, more to the point, how we perceive. Decades of psychological research and new brain scanning studies have shown that our minds distort information. We overvalue some data and mistakenly discard details that contradict our assumptions. When we hear words like “robot,” “genomics” and “3D printing,” we automatically believe the results will be superior to any alternative, even in the absence of supporting proof. And when we learn that surgeons are deploying these “next-generation products,” and that particular hospitals offer them, we perceive that these doctors and facilities are somehow more sophisticated and advanced, with better patient outcomes all but guaranteed.
Worst of all, device companies, hospitals and specialists have figured out how to exploit these misperceptions and, in the process, attract referrals and charge premium prices for products and services. Manufacturers understand that once a few prominent physicians and high-profile hospitals play early adopter, everyone else in the community will have to follow, or risk being seen as lagging behind the quality curve—so they promote and advertise on behalf of the ones who do.
In contrast, others have used 3D printing to create more affordable solutions. As an example, a combination of high school and college students in Cincinnati, using design specifications created by a global not-for-profit called e-Nable, have constructed custom-made prosthetic body parts out of plastic for children with partial amputations—at a cost of $20 each. Thanks to the low cost, the old prostheses can be frequently replaced with new ones as the children grow. They are not meant to replace the most sophisticated total arm prostheses that cost $6,000 to $10,000; however, they solve a medical need and do so inexpensively.
But here’s the question: do you believe a U.S. company would ever develop this type of low-cost solution rather than offer only a high-priced one? They recognize that to create a billion-dollar company, you don’t look for low-cost solutions, even when they can fully address patient need.
The Affordable Care Act
The Affordable Care Act, the future of which Washington D.C. is again vigorously debating, intersects with our culture of embracing the new over the traditional. The fundamental challenge Congress and the president are grappling with is the increasingly unaffordable cost of U.S. healthcare. Expand coverage and people will get the medical care they need to improve their lives, but at higher cost to the government. That’s the central conundrum at play in the current national debate.
The reasons healthcare expenses in the United States are higher than the rest of the world’s are myriad, but the economics of American medicine is a huge contributor. If we focus on lifestyle changes such as smoking, diet and exercise, we could lower the disease burden in the U.S., decrease costs and improve overall health. But doing so will take hard work, and be difficult for companies to monetize. In contrast, sell a new drug at $100,000 a year, or even buy the rights to an old drug and raise the price 1,000%, and profit is all but guaranteed. Convince hospitals to buy a cancer-detecting surgical knife and surgeons to demand a 3D-printed joint replacement implant, and your company will be profitable and its stock price will rise exponentially.
If we are to overcome the economic threats our nation faces from escalating healthcare costs, we all have a role to play. Each of us who uses or provides healthcare services will be required to contribute to addressing the problems now so widespread. Those who believe it will come through the next big discovery or the newest device are likely to be disappointed. Manufacturers are unlikely to pursue low-cost solutions, and the media is more likely to focus on what is possible than what is known. We can wait for the next big discovery to make healthcare more affordable, but if we decide to do so, I predict we will have a long time to wait.
This article originally appeared on Dr. Pearl’s blog on Forbes.com