For-profit companies have long sought to tap into the fears of consumers, offering pricey medical scans they can access without a doctor’s recommendation, as long as they can pay the price out of pocket.
Now, some of these ventures are trumpeting scans assisted by artificial intelligence, essentially cutting-edge computer technology they say can reveal hidden health problems, from cancer to obscure bone disorders, and analyze the results more quickly than those typically ordered by doctors. Researchers say artificial intelligence, known as AI, holds the promise of more precise diagnosis and also the ability to shorten waiting times for results.
But are these new body scans for the “worried well” surging ahead of the current science on artificial intelligence? As the debate heats up, a California-based company is planning to open in Massachusetts.
“There is certainly not enough known about the use of [artificial intelligence] in direct-to-consumer imaging services,” Dr. Catherine Livingston, associate professor of family medicine at Oregon Health Sciences University School of Medicine, said in an e-mail. Livingston is the lead author of a 2016 report by the American College of Preventative Medicine that recommended against whole-body scans for early tumor detection in patients who have no obvious symptoms.
“We don’t even know that the benefits outweigh harms for whole body scans in asymptomatic people. Adding in ... AI is a Pandora’s box,” she said.
Even before AI, many major medical groups warned against consumer-based body scans, saying there is little evidence they save lives or improve health. They warn that such scans have the potential for false-positive findings that can result in unnecessary testing and procedures with additional risks, such as exposure to radiation from follow-up testing, not to mention additional costs.
A California-based company, Prenuvo, which offers whole body scans with AI for $2,499, is slated to open in Massachusetts later this year. Prenuvo is already up and running in several areas, including Silicon Valley, Boca Raton, Dallas, and Minneapolis, and says other new sites this year will include Chicago, New York City, and Washington, D.C.
The company has provided “around 250,000 overall diagnoses and around 5 percent being quite serious and requiring immediate follow up,” Andrew Lacy, Prenuvo’s founder and chief executive, said in an interview.
Lacy declined to say how many people the company has scanned since opening in 2018, but he said one customer might have several diagnoses.
Lacy said the types of clinically significant issues the scans have found include stage one liver, kidney, pancreatic, and brain cancer, as well as herniated discs and arthritis.
Still, Dr. Jennifer Haas, a primary care physician who specializes in health care disparities and cancer screening and prevention at Massachusetts General Hospital, is skeptical about commercialized whole body scans. She said the procedure for people who don’t have obvious health risks may place further stress on a swamped health care system, when people who receive whole body scans need evaluations for “incidental findings” that don’t ultimately wind up being a problem.
“You will have people with an unproven test who are going to need follow-up, and who are going to push people away who need evidence-based care,” she said.
That describes what just happened to Johanna Beyer, a 52-year-old Silicon Valley executive coach who recently had a Prenuvo body scan because a friend of a friend said his scan found an early brain tumor.
“I’ve been going through menopause and have had some friends recently die of breast cancer, all these crazy things happening,” she said. “And I thought, why not?”
The results showed an “abnormality” — a tiny brain aneurysm. Beyer, panicked, texted her friend, Dr. Christopher Hess, a professor and chair of radiology and biomedical imaging at the University of California San Francisco.
Hess’s take? “Even if it is an aneurysm, such small aneurysms are unlikely to rupture and most experts would not treat.”
Still, all her friends want a scan now, Beyer said. “But after this experience, I would say not to.”
Hess, in an interview, said AI is playing a vital role in helping radiologists more quickly sort through mountains of scans to prioritize which need urgent attention. The technology is also helping radiologists detect subtle changes they might have missed.
Researchers have developed AI that can help diagnose illnesses by training computers with thousands of scans until they learn to distinguish healthy from, say, cancerous tissue. It’s similar to how scientists have trained computers to recognize patterns in a consumer’s online shopping history and then recommend additional products the consumer may want to buy.
But Hess, who directs a UCSF center on AI and medical imaging, said that aside from routinely recommended cancer screenings for such things as breast and colon cancer, preventative screening only makes sense if a patient has a known higher risk, such as a smoker screening for lung cancer.
“There are a number of very good modalities, even coronary heart screening for heart disease patients with a family history, but all of this is based on family risk,” he said.
In Massachusetts, whole body screening companies can fall into a gray area for regulatory oversight. Prenuvo does not meet the Massachusetts definition of a clinic, which would be overseen by the state health department, according to the agency. Any health professional working at the company, however, would have to meet state licensing requirements.
The state’s Radiation Control Program regulates medical device machines that emit ionizing radiation, such as X-rays, CAT scans, and bone densitometry machines. Machines that do not use ionizing radiation, including MRIs as well as ultrasounds and EKGs, are not regulated by the program. So Prenuvo, which offers MRI scans, would not fall under this regulation, either.
Lacy, Prenuvo’s chief executive, said the company hopes to team up with local researchers in Massachusetts opening to study the efficacy of its whole body screening. He said the company has produced several research papers about its artificial intelligence-assisted scans, but they are all under embargo until they are presented next month at an American Academy of Neurology conference and later in June at an MRI industry gathering.
Livingston, the professor from Oregon Health Sciences University School of Medicine, said artificial intelligence-assisted scans will likely have an important role to play in many areas of medicine, but that they still need to be “exhaustively tested to make sure that it is accurate, reliable, and, most importantly, that the use of AI actually improves patient outcomes and does not cause harm.”
“We are a long way from that right now in medical imaging screening in asymptomatic disease,” she said. “And the stakes in medicine are high. We are talking about people’s lives.”