With tech, you pretty much know that each new generation of smart phone or laptop is going to be better: faster processing, better screen resolution, more apps — more of everything. 

Medical care doesn’t work that way.

Not that you would ever know that from the steady drumbeat of breathless “breakthrough!” publicity from medical institutions. They want patients to think that the latest innovation really is the greatest. Often, it’s not. Time and again, new treatments and tests offer no proven benefit to patients. They just cost a lot more.

Yes, there are genuine medical advances that help patients heal better and live longer. Many selfless researchers are focused 24/7/365 on making things better.  The problem is, patients, get hurt when they’re lulled into new stuff that’s really no better than the old ways. So we need to sort the genuine from the inflated.

This month, we focus on five examples of overhyped medical treatments and testing. Readers may see some common themes that will help make for clear-eyed focus next time you’re presented with the chance to jump on board with a new innovation for your own care.
 

It’s an infomercial pitch still common on local TV stations in hours far from prime time. A wide-eyed broadcaster turns to a scrubs-wearing surgeon who extols the virtues of robot-assisted procedures. The hype for the machines, which cost hospitals millions of dollars or more annually, asserts that they do wonders — in surgeries for the knee, abdomen, pelvis, and more.

But after years of rigorous, independent research, the devices that doctors and hospitals push so hard have not shown better results for patients. Surgeons say robots make it more comfortable for them to work in keyhole or laparoscopic procedures. But robotic procedures often last longer, cost more, and do not produce measurably better results. In August 2021, researchers conducted a meta-analysis, digging into 50 published studies on robotic surgery. Dr. Naila H. Dhanani, a lead author of that work, told the New York Times that for a patient, there is no reason to choose robotic surgery over other approaches: “Just because something’s new and fancy doesn’t mean it’s the better technique. Yes, robotic is safe, we’ve proven that. But we haven’t proven it’s better.”  Dr. James A. Eastham, chief of urology at Memorial Sloan Kettering Cancer Center, who was not involved in the study, told the newspaper: “It is far more important to select an experienced surgeon with specialization in a particular field rather than picking a technique.”

Critics also have drawn a starker picture of the risks posed by surgical robots, arguing that they harm patients, particularly because doctors can jump on them and begin operating on people with thin training. The federal Food and Drug Administration has warned surgeons anew that robots should not be used — including in clinical trials — in mastectomies and other breast cancer procedures. 

For decades, medical researchers have reveled in the possibility that life-changing treatments would flow from scientists’ remarkable discovery that they could reproduce a seemingly magical building block of human life: stem cells. Enthusiasm for research on these transforming cells — and the hope that they might play a major role in battling cancer, diabetes, and other disorders, while also rejuvenating or replacing organs — led California voters to commit $8 billion for study in this field.

While stem cell research has dominated headlines and become an obsession of elite medical centers, the federal Food and Drug Administration as of March had approved only a handful of stem cell therapies.

That has not halted a costly, dangerous stampede of purveyors claiming to use stem cells in unapproved treatments for arthritis, Alzheimer’s, disease, Covid-19. and many other conditions. This is how the Verge news site described the risks of this trend, which the FDA was supposed to crack down on but has not: “[T]he products have a dubious safety record. People have gone blind after receiving unregulated stem cell treatments. Non-FDA-approved treatments have also been linked to kidney failure and bacterial infections. Unproven and potentially dangerous therapies have become so prevalent that in 2019, Google announced it would ban ads for them.”

The FDA in 2017 gave stem cell proponents three years to prove specific, alleged treatments would work and not harm patients. But the agency has dithered while the business has exploded.  As the Verge reported, based on the published work of Leigh Turner, a University of California, Irvine, professor: “As Turner sees it, with nearly 1,500 businesses operating 2,754 stem cell treatment clinics in the U.S. in March 2021, whatever warnings regulators have issued to try and rein in the industry aren’t working.” Instead, the business is morphing, with providers now claiming to extract patients’ own tissues — including fat from their posteriors — and supposedly processing, manipulating, or repurposing it for dubious use in patients.

By the way, big, fancy hospitals also have jumped into the stem-cell clamor, pressing what critics have assailed as the evidence-light and highly lucrative area of “regenerative medicine.”

Critics have watched with dismay as Silicon Valley entrepreneurs have shoved their way into U.S. health care, including with the rapid expansion of prenatal testing. The firms found initial success with blood screens to detect Down syndrome. These tests —intended to detect minute deletions in fetal chromosomes (microdeletions) — were cheaper than conventional testing of the mother’s amniotic fluid, and the hard-charging marketing whizzes saw opportunities to persuade expectant parents to rely on them.

They then advertised that the screenings, administered early in pregnancy and requiring just a few vials of blood, could detect rarer and rarer developmental disorders in the unborn. Without disclosing supporting data, the companies boasted about the tests’ accuracy.

The New York Times dug into why so many couples spend thousands of dollars on screens and what they purport to tell potential parents.

Major problems surfaced fast in what experts say soon may be a billion-dollar-a-year business, the newspaper found: “The grave predictions made by those newer tests are usually wrong …To evaluate [them], The Times interviewed researchers and then combined data from multiple studies to produce the best estimates available of how well the five most common microdeletion tests perform. The analysis showed that positive results on those tests are incorrect about 85% of the time.”

Further, the companies, at best, glossed over warnings to patients that the tests both can produce false positives and require follow-up. They are screenings, not diagnostic tools, meaning their alerts must be confirmed with further exams that can be costly and invasive. While patients often receive extensive counseling about genetic tests and their results, this has not occurred with the speedy blood tests. Sadly, the newspaper learned about couples who terminated pregnancies based on alarming blood screens alone.

Federal officials say they typically neither regulate nor approve the “laboratory developed” screenings. Still, the FDA has publicly cautioned consumers, with the New York Times reporting: “The agency warned doctors not to diagnose genetic disorders based on these results alone and stressed the need to follow positive screenings with more reliable ‘diagnostic’ testing. It said it was ‘aware of reports’ that some women ‘have ended pregnancies based only on the results’ of these genetic screening tests. ‘While genetic noninvasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science,’ ” the agency’s top testing official said.

Walmart has said it is so. So has the insurer Anthem. Ditto medical experts publishing in the Journal of the American Medical Association. They all have criticized doctors’ and hospitals’ excessive use of medical imaging — not mammograms or routine X-rays, say, of broken bones. No, for years critics have targeted the excessive use of CT, PET and MRI scans.

As a study in JAMA found in 2018 (as reported by the trade publication Health Imaging): “The U.S. performed the second highest number of imaging exams … and had the second highest MRI and CT technology utilization rate, following Japan … The average cost of a CT exam in the U.S. was $896 per scan as compared to $97 in Canada, $279 in the Netherlands, and $500 in Australia …. The U.S. [after Japan] had the second highest number of MRI units [per million patients] … and the third highest number of CT scanners …” This country could save billions of dollars if it reduced the number and cost of imaging, wrote Dr. Ezekiel Emanuel, of the University of Pennsylvania’s medical school, in an accompanying [JAMA] editorial. He noted that evidence showed that “up to a third” of the procedures “may be deemed unnecessary and carry radiation risks …”

Walmart and Anthem both have cracked down on CT and MRI scans they will pay for, telling patients over whom they have a say to use imaging providers they recommend. That’s because they have found not only over-use of imaging but also issues with its cost and challenges with the accuracy or interpretation of results. As the Kaiser Health News service reported: “Studies show a 3% to 5% error rate each work day in a typical radiology practice, but some academic research has found mistakes on advanced images such as CT scans and MRIs can reach up to 30% of diagnoses. Although not every mistake affects patient care, with millions of CT scans and MRIs done each year in the United States, such mistakes can have a significant impact.”

Patients with concerns— and who don’t want to get caught up in big hospitals nearby competing with each other by buying and promoting the fanciest, most expensive, and latest imaging devices and services — can study guidelines provided by reputable experts. They can consider the American College of Radiology recommendations for the Choosing Wisely program on imaging options that patients should question when doctors order them. Or they can consult advisories on imaging procedures like lung cancer scans or mammograms as issued by the U.S. Preventive Services Task Force, a top federal panel that provides independent, influential guidance on medical tests and screenings.

Big Pharma, with its mastery of public messaging, would love for Americans to think that this is a Golden Age for cancer care. After all, federal regulators are approving more cancer drugs than ever, many of them at an accelerated pace. For patients, this must mean that doctors have more and better options to battle one of the nation’s leading killers, right?

Well, not exactly. Cancer treatment has improved, and increasing numbers of people who have survived bouts of various types of the disease attest to this. Still, a rising chorus of critics argue, as one recent study explained: “Although several oncology and malignant hematology drugs receive FDA approval each month, it is unclear how many of these cancer drugs transform the treatment landscape significantly … It remains unclear how many of these newly approved cancer drugs displace the existing standard-of-care therapies … compared with providing simply an alternative treatment option.”

The researchers, in their scrutiny, determined that “14% of new drug approvals displaced existing standards of care, and an additional 15% provided market competition. At the same time, 29% were add-on or maintenance drugs that can only increase the cost of care. Forty-two percent were drugs approved for patients who had exhausted other treatment options.” Another critic summarized his stark reality check about many “wonder drugs” thusly: “For the most part, cancer drugs cost too much and deliver too little. Because of this, their value is poor.”

Cancer specialists, at last, have recognized the tough challenges patients confront with the bankrupting cost of prescription medications and other treatments that create the disease’s “financial toxicity.” A big reason for the nightmares: Big Pharma has gotten the FDA to approve drugs that cost tens or hundreds of thousands of dollars, not because they improve or extend patients’ lives. Instead, the agency bases its decisions on “surrogate endpoints,” measures such as whether a medication shrinks a tumor for a given period. This means that patients — if their finances or insurance allows it — can be forced into impossible choices: Is a 2.5-month increase in survival (the median for a typical cancer drug) worth going broke over or seeing that happen to their loved ones? And how many times should a late-stage patient try different, expensive cancer drugs in hopes of finding a helpful treatment?