“Virtual Biopsies” May Soon Make Some Invasive Tests Unnecessary
At his son's college graduation in 2017, Dan Chessin felt "terribly uncomfortable" sitting in the stadium. The bouts of pain persisted, and after months of monitoring, a urologist took biopsies of suspicious areas in his prostate.
This innovation may enhance diagnostic precision and promptness, but it also brings ethical concerns to the forefront.
"In my case, the biopsies came out cancerous," says Chessin, 60, who underwent robotic surgery for intermediate-grade prostate cancer at University Hospitals Cleveland Medical Center.
Although he needed a biopsy, as most patients today do, advances in radiologic technology may make such invasive measures unnecessary in the future. Researchers are developing better imaging techniques and algorithms—a form of computer science called artificial intelligence, in which machines learn and execute tasks that typically require human brain power.
This innovation may enhance diagnostic precision and promptness. But it also brings ethical concerns to the forefront of the conversation, highlighting the potential for invasion of privacy, unequal patient access, and less physician involvement in patient care.
A National Academy of Medicine Special Publication, released in December, emphasizes that setting industry-wide standards for use in patient care is essential to AI's responsible and transparent implementation as the industry grapples with voluminous quantities of data. The technology should be viewed as a tool to supplement decision-making by highly trained professionals, not to replace it.
MRI--a test that uses powerful magnets, radio waves, and a computer to take detailed images inside the body--has become highly accurate in detecting aggressive prostate cancer, but its reliability is more limited in identifying low and intermediate grades of malignancy. That's why Chessin opted to have his prostate removed rather than take the chance of missing anything more suspicious that could develop.
His urologist, Lee Ponsky, says AI's most significant impact is yet to come. He hopes University Hospitals Cleveland Medical Center's collaboration with research scientists at its academic affiliate, Case Western Reserve University, will lead to the invention of a virtual biopsy.
A National Cancer Institute five-year grant is funding the project, launched in 2017, to develop a combined MRI and computerized tool to support more accurate detection and grading of prostate cancer. Such a tool would be "the closest to a crystal ball that we can get," says Ponsky, professor and chairman of the Urology Institute.
In situations where AI has guided diagnostics, radiologists' interpretations of breast, lung, and prostate lesions have improved as much as 25 percent, says Anant Madabhushi, a biomedical engineer and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve, who is collaborating with Ponsky. "AI is very nascent," Madabhushi says, estimating that fewer than 10 percent of niche academic medical centers have used it. "We are still optimizing and validating the AI and virtual biopsy technology."
In October, several North American and European professional organizations of radiologists, imaging informaticists, and medical physicists released a joint statement on the ethics of AI. "Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future," reads the statement, published in the Journal of the American College of Radiology. "The radiology community should start now to develop codes of ethics and practice for AI that promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes."
Overreliance on new technology also poses concern when humans "outsource the process to a machine."
The statement's leader author, radiologist J. Raymond Geis, says "there's no question" that machines equipped with artificial intelligence "can extract more information than two human eyes" by spotting very subtle patterns in pixels. Yet, such nuances are "only part of the bigger picture of taking care of a patient," says Geis, a senior scientist with the American College of Radiology's Data Science Institute. "We have to be able to combine that with knowledge of what those pixels mean."
Setting ethical standards is high on all physicians' radar because the intricacies of each patient's medical record are factored into the computer's algorithm, which, in turn, may be used to help interpret other patients' scans, says radiologist Frank Rybicki, vice chair of operations and quality at the University of Cincinnati's department of radiology. Although obtaining patients' informed consent in writing is currently necessary, ethical dilemmas arise if and when patients have a change of heart about the use of their private health information. It is likely that removing individual data may be possible for some algorithms but not others, Rybicki says.
The information is de-identified to protect patient privacy. Using it to advance research is akin to analyzing human tissue removed in surgical procedures with the goal of discovering new medicines to fight disease, says Maryellen Giger, a University of Chicago medical physicist who studies computer-aided diagnosis in cancers of the breast, lung, and prostate, as well as bone diseases. Physicians who become adept at using AI to augment their interpretation of imaging will be ahead of the curve, she says.
As with other new discoveries, patient access and equality come into play. While AI appears to "have potential to improve over human performance in certain contexts," an algorithm's design may result in greater accuracy for certain groups of patients, says Lucia M. Rafanelli, a political theorist at The George Washington University. This "could have a disproportionately bad impact on one segment of the population."
Overreliance on new technology also poses concern when humans "outsource the process to a machine." Over time, they may cease developing and refining the skills they used before the invention became available, said Chloe Bakalar, a visiting research collaborator at Princeton University's Center for Information Technology Policy.
"AI is a paradigm shift with magic power and great potential."
Striking the right balance in the rollout of the technology is key. Rushing to integrate AI in clinical practice may cause harm, whereas holding back too long could undermine its ability to be helpful. Proper governance becomes paramount. "AI is a paradigm shift with magic power and great potential," says Ge Wang, a biomedical imaging professor at Rensselaer Polytechnic Institute in Troy, New York. "It is only ethical to develop it proactively, validate it rigorously, regulate it systematically, and optimize it as time goes by in a healthy ecosystem."
New implants let paraplegics surf the web and play computer games
When I greeted Rodney Gorham, age 63, in an online chat session, he replied within seconds: “My pleasure.”
“Are you moving parts of your body as you type?” I asked.
This time, his response came about five minutes later: “I position the cursor with the eye tracking and select the same with moving my ankles.” Gorham, a former sales representative from Melbourne, Australia, living with amyotrophic lateral sclerosis, or ALS, a rare form of Lou Gehrig’s disease that impairs the brain’s nerve cells and the spinal cord, limiting the ability to move. ALS essentially “locks” a person inside their own body. Gorham is conversing with me by typing with his mind only–no fingers in between his brain and his computer.
The brain-computer interface enabling this feat is called the Stentrode. It's the brainchild of Synchron, a company backed by Amazon’s Jeff Bezos and Microsoft cofounder Bill Gates. After Gorham’s neurologist recommended that he try it, he became one of the first volunteers to have an 8mm stent, laced with small electrodes, implanted into his jugular vein and guided by a surgeon into a blood vessel near the part of his brain that controls movement.
After arriving at their destination, these tiny sensors can detect neural activity. They relay these messages through a small receiver implanted under the skin to a computer, which then translates the information into words. This minimally invasive surgery takes a day and is painless, according to Gorham. Recovery time is typically short, about two days.
When a paralyzed patient thinks about trying to move their arms or legs, the motor cortex will fire patterns that are specific to the patient’s thoughts.
When a paralyzed patient such as Gorham thinks about trying to move their arms or legs, the motor cortex will fire patterns that are specific to the patient’s thoughts. This pattern is detected by the Stentrode and relayed to a computer that learns to associate this pattern with the patient’s physical movements. The computer recognizes thoughts about kicking, making a fist and other movements as signals for clicking a mouse or pushing certain letters on a keyboard. An additional eye-tracking device controls the movement of the computer cursor.
The process works on a letter by letter basis. That’s why longer and more nuanced responses often involve some trial and error. “I have been using this for about two years, and I enjoy the sessions,” Gorham typed during our chat session. Zafar Faraz, field clinical engineer at Synchron, sat next to Gorham, providing help when required. Gorham had suffered without internet access, but now he looks forward to surfing the web and playing video games.
Gorham, age 63, has been enjoying Stentrode sessions for about two years.
Rodeny Dekker
The BCI revolution
In the summer of 2021, Synchron became the first company to receive the FDA’s Investigational Device Exemption, which allows research trials on the Stentrode in human patients. This past summer, the company, together with scientists from Icahn School of Medicine at Mount Sinai and the Neurology and Neurosurgery Department at Utrecht University, published a paper offering a framework for how to develop BCIs for patients with severe paralysis – those who can't use their upper limbs to type or use digital devices.
Three months ago, Synchron announced the enrollment of six patients in a study called COMMAND based in the U.S. The company will seek approval next year from the FDA to make the Stentrode available for sale commercially. Meanwhile, other companies are making progress in the field of BCIs. In August, Neuralink announced a $280 million financing round, the biggest fundraiser yet in the field. Last December, Synchron announced a $75 million financing round. “One thing I can promise you, in five years from now, we’re not going to be where we are today. We're going to be in a very different place,” says Elad I. Levy, professor of neurosurgery and radiology at State University of New York in Buffalo.
The risk of hacking exists, always. Cybercriminals, for example, might steal sensitive personal data for financial reasons, blackmailing, or to spread malware to other connected devices while extremist groups could potentially hack BCIs to manipulate individuals into supporting their causes or carrying out actions on their behalf.
“The prospect of bestowing individuals with paralysis a renewed avenue for communication and motor functionality is a step forward in neurotech,” says Hayley Nelson, a neuroscientist and founder of The Academy of Cognitive and Behavioral Neuroscience. “It is an exciting breakthrough in a world of devastating, scary diseases,” says Neil McArthur, a professor of philosophy and director of the Centre for Professional and Applied Ethics at the University of Manitoba. “To connect with the world when you are trapped inside your body is incredible.”
While the benefits for the paraplegic community are promising, the Stentrode’s long-term effectiveness and overall impact needs more research on safety. “Potential risks like inflammation, damage to neural tissue, or unexpected shifts in synaptic transmission due to the implant warrant thorough exploration,” Nelson says.
There are also concens about data privacy concerns and the policies of companies to safeguard information processed through BCIs. “Often, Big Tech is ahead of the regulators because the latter didn’t envisage such a turn of events...and companies take advantage of the lack of legal framework to push forward,” McArthur says. Hacking is another risk. Cybercriminals could steal sensitive personal data for financial reasons, blackmailing, or to spread malware to other connected devices. Extremist groups could potentially hack BCIs to manipulate individuals into supporting their causes or carrying out actions on their behalf.
“We have to protect patient identity, patient safety and patient integrity,” Levy says. “In the same way that we protect our phones or computers from hackers, we have to stay ahead with anti-hacking software.” Even so, Levy thinks the anticipated benefits for the quadriplegic community outweigh the potential risks. “We are on the precipice of an amazing technology. In the future, we would be able to connect patients to peripheral devices that enhance their quality of life.”
In the near future, the Stentrode could enable patients to use the Stentrode to activate their wheelchairs, iPods or voice modulators. Synchron's focus is on using its BCI to help patients with significant mobility restrictions—not to enhance the lives of healthy people without any illnesses. Levy says we are not prepared for the implications of endowing people with superpowers.
I wondered what Gorham thought about that. “Pardon my question, but do you feel like you have sort of transcended human nature, being the first in a big line of cybernetic people doing marvelous things with their mind only?” was my last question to Gorham.
A slight smile formed on his lips. In less than a minute, he typed: “I do a little.”
Leading XPRIZE Healthspan and Beating Negativity with Dr. Peter Diamandis
A new competition by the XPRIZE Foundation is offering $101 million to researchers who discover therapies that give a boost to people aged 65-80 so their bodies perform more like when they were middle-aged.
For today’s podcast episode, I talked with Dr. Peter Diamandis, XPRIZE’s founder and executive chairman. Under Peter’s leadership, XPRIZE has launched 27 previous competitions with over $300 million in prize purses. The latest contest aims to enhance healthspan, or the period of life when older people can play with their grandkids without any restriction, disability or disease. Such breakthroughs could help prevent chronic diseases that are closely linked to aging. These illnesses are costly to manage and threaten to overwhelm the healthcare system, as the number of Americans over age 65 is rising fast.
In this competition, called XPRIZE Healthspan, multiple awards are available, depending on what’s achieved, with support from the nonprofit Hevolution Foundation and Chip Wilson, the founder of Lululemon and nonprofit SOLVE FSHD. The biggest prize, $81 million, is for improvements in cognition, muscle and immunity by 20 years. An improvement of 15 years will net $71 million, and 10 years will net $61 million.
In our conversation for this episode, Peter talks about his plans for XPRIZE Healthspan and why exponential technologies make the current era - even with all of its challenges - the most exciting time in human history. We discuss the best mental outlook that supports a person in becoming truly innovative, as well as the downsides of too much risk aversion. We talk about how to overcome the negativity bias in ourselves and in mainstream media, how Peter has shifted his own mindset to become more positive over the years, how to inspire a culture of innovation, Peter’s personal recommendations for lifestyle strategies to live longer and healthier, the innovations we can expect in various fields by 2030, the future of education and the importance of democratizing tech and innovation.
In addition to Peter’s pioneering leadership of XPRIZE, he is also the Executive Founder of Singularity University. In 2014, he was named by Fortune as one of the “World’s 50 Greatest Leaders.” As an entrepreneur, he’s started over 25 companies in the areas of health-tech, space, venture capital and education. He’s Co-founder and Vice-Chairman of two public companies, Celularity and Vaxxinity, plus being Co-founder & Chairman of Fountain Life, a fully-integrated platform delivering predictive, preventative, personalized and data-driven health. He also serves as Co-founder of BOLD Capital Partners, a venture fund with a half-billion dollars under management being invested in exponential technologies and longevity companies. Peter is a New York Times Bestselling author of four books, noted during our conversation and in the show notes of this episode. He has degrees in molecular genetics and aerospace engineering from MIT and holds an M.D. from Harvard Medical School.
Show links
- Peter Diamandis bio
- New XPRIZE Healthspan
- Peter Diamandis books
- 27 XPRIZE competitions and counting
- Life Force by Peter Diamandis and Tony Robbins
- Peter Diamandis Twitter
- Longevity Insider newsletter – AI identifies the news
- Peter Diamandis Longevity Handbook
- Hevolution funding for longevity
XPRIZE Founder Peter Diamandis speaks with Mehmoud Khan, CEO of Hevolution Foundation, at the launch of XPRIZE Healthspan.
Hevolution Foundation