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The FDA Needs to Set Standards for Using Artificial Intelligence in Drug Development

By CHARLES K. FISHER, PhD

Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many consumer devices. In less than a decade, machine learning algorithms based on deep neural networks evolved from recognizing cats in videos to enabling your smartphone to perform real-time translation between 27 different languages. This progress has sparked the use of AI in drug discovery and development.

Artificial intelligence can improve efficiency and outcomes in drug development across therapeutic areas. For example, companies are developing AI technologies that hold the promise of preventing serious adverse events in clinical trials by identifying high-risk individuals before they enroll. Clinical trials could be made more efficient by using artificial intelligence to incorporate other data sources, such as historical control arms or real-world data. AI technologies could also be used to magnify therapeutic responses by identifying biomarkers that enable precise targeting of patient subpopulations in complex indications.

Innovation in each of these areas would provide substantial benefits to those who volunteer to take part in trials, not to mention downstream benefits to the ultimate users of new medicines.

Misapplication of these technologies, however, can have unintended harmful consequences. To see how a good idea can turn bad, just look at what’s happened with social media since the rise of algorithms. Misinformation spreads faster than the truth, and our leaders are scrambling to protect our political systems.

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Health in 2 Point 00, Episode 109 | Flywire & Simplee, Headspace, and Iora Health

Today on Health in 2 Point 00, we’re celebrating Valentine’s Day with many new funding deals! On Episode 109, Jess and I discuss Flywire, a payment startup that received not only $120 million from Goldman Sachs, reaching unicorn status, but also acquired the healthcare payments company Simplee which aids the hospital-patient billing process. Headspace raises $93 million, around half of which will be used to build a new ‘Health’ category and the other half to teach meditation. Outset medical raises $125 million for a portable dialysis machine and Iora Health raises $126 million for Series F funding. Finally, I give my take on patient-centric SaaS company Seqster receiving an undisclosed amount from Takeda. –Matthew Holt

Mindful Daily Practice Offers an Antidote to Healthcare Burnout

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By GREG HAMMER, MD

Burnout among healthcare professionals is at an all-time high. Its drivers include longer work hours, the push to see more patients, more scrutiny by administrators, and loss of control over our practice. We seem to spend more time with the electronic medical record and less time face-to-face with our patients.

I have faced burnout personally. My son passed away at the age of 29, which was beyond painful. At the same time, I felt burdened by the growing number and complexity of metrics by which I was judged at work. Days in the operating room and intensive care unit seemed more and more exhausting, and my patience was becoming shorter and shorter. I was fortunate to have had a long-standing meditation practice as well as sabbatical time that I used to decompress and re-evaluate my career. Many of us are not so lucky. More than half of physicians have serious signs of burnout, and more than one physician commits suicide every day.

So many of us feel burned out these days because in our rapidly changing profession we are asked to do more for less and with inadequate resources. We suffer from exhaustion, self-criticism, and worry about what will happen next to our practice, our families, and ourselves. If we want to save our practices, patients, marriages- even our lives, we must acquire personal resilience.

Fortunately, we can increase our resilience and happiness and reverse burnout by embracing a few simple principles—Gratitude, Acceptance, Intention, and Nonjudgment (GAIN)—that we can put into motion in our everyday lives at the hospital, at home, or wherever we are.

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From Ophthalmology Clinic to At-Home Device: Disrupting OTC Testing | Helge Sudkamp, Visotec

By JESSICA DaMASSA, WTF HEALTH

Optical coherence tomography, otherwise known as OCT testing, gives eye doctors a glimpse of the retina to help detect eye diseases like glaucoma, macular degeneration, retinopathy, and more. So, what’s wrong with current methods of testing? Helge Sudkamp, CEO & co-founder of Visotec, explains how traditional OCT machines are huge, bulky and expensive — limiting scanning to infrequent visits at the doctor’s office. His company has a new take on OCT tech that puts the scanning into patients’ hands with a small, portable device that can be used daily AT HOME. What can daily at-home monitoring offer eye patients and their doctors? Never-before-collected data on the day-to-day progress of eye disease for one. Find out more about how Visotec ultimately hopes to leverage this new info to build algorithms into their devices that will be able to detect biomarkers that help identify eye diseases faster.

Filmed at Bayer G4A Signing Day in Berlin, Germany, October 2019.

The Step 1 Score Reporting Change – A Step in the Right Direction for IMGs?

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By TALAL HILAL, MD

The United States Medical Licensing Examination (USMLE) Step 1, a test co-sponsored by the Federation of State Medical Boards (FSMB) and the National Board of Medical Examiners (NBME), has been the exam that people love to hate. For many years, blogs, Twitter feeds, and opinion pieces have been accumulating urging the presidents of the FSMB/NBME to stop reporting a 3-digit score and instead report a pass/fail score. This animosity towards the Step 1 exam originates from the reality that medical schools have increasingly focused their curriculum on teaching what the Step 1 wants you to learn – medical trivia that almost always has no bearing on how to approach a clinical problem.

This “Step 1 Madness” is unhealthy. The reasons for its existence are many: residency and fellowship programs allow it to exist by idolizing higher scores, some believe it is a metric that can predict future quality of care, board pass rates, etc. And some are naïve enough to think that what is tested on the Step 1 is actually useful medical knowledge! It may be due to a combination of the above that the Step 1 has found itself in such a peculiar spot. However, the emphasis on the Step 1 score means that medical students’ fate is being determined by a single test. Nobody wants their fate to be so unmalleable.

Those who were writing vehemently against a 3-digit score rejoiced when the FSMB/NBME announced on February 12 that the Step 1 will finally become a pass/fail test as early as January 2022!

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#USMLEPassFail: A Brave New Day

By BRYAN CARMODY, MD

Well, it happened.

Beginning as soon as 2022, USMLE Step 1 scores will be reported pass/fail.

I’m shocked. Starting around two weeks ago, I began hearing rumors from some well-connected people that this might happen… but I still didn’t believe it.

I was wrong.

The response thus far has been enormous – I haven’t been able to clear my Twitter mentions since the news broke. And unsurprisingly, the reaction has been mixed.

In the future, I’ll post more detailed responses on where we go from here – but for now, I’d like to emphasize these five things.

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Taking Healthcare Innovation Beyond the “Peloton Crowd” | Andy Slavitt, Town Hall Ventures

By JESSICA DaMASSA, WTF HEALTH

Andy Slavitt, former Acting Administrator of the Centers for Medicare and Medicaid Services and founder and partner at Town Hall Ventures, talks about how venture capitalists and health tech startups can help make healthcare more affordable and accessible for the 130 million Americans beyond the “Peloton crowd.” We ask Andy if he thinks “social determinants of health” is more than just an industry buzzword, get his advice for startups motivated to make a difference, and hear his predictions for what will change healthcare in this new decade.

Filmed at J.P. Morgan Healthcare Conference in San Francisco, January 2020.

Healthcare Has a Moral Injury

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By KIM BELLARD

The term “moral injury” is a term originally applied to soldiers as a way to help explain PTSD and, more recently, to physicians as a way to help explain physician burnout.  The concept is that moral injury is what can happen to people when “perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.”  

I think healthcare generally has a bad case of moral injury.  

How else can we explain physicians practicing surprise billing, hospitals suing patients, health plans refusing to pay for pre-authorized treatments, or pharmaceutical companies charging “skyrocketing” costs even for common, essential prescription drugs?  There are people involved in each of these, and countless more examples.  If those people haven’t suffered a moral injury as a result, it’s hard to understand why.  

Melissa Bailey, writing for Kaiser Health News, looked at moral injury from the standpoint of emergency room physicians.  One physician decried how “the real priority is speed and money and not our patients’ care.”  Another made a broader charge: “The health system is not set up to help patients. It’s set up to make money.”  He urged that physicians seek to understand “how decisions made at the systems level impact how we care about patients” — so they can “stand up for what’s right.”

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Health Catalyst’s New Data-Driven Life Sciences Business | Sadiqa Mahmood, Health Catalyst

By JESSICA DaMASSA, WTF HEALTH

As if an IPO weren’t enough big news for Health Catalyst in 2019, the company also launched a brand-new life sciences business, basically setting forth a new solution for a completely new set of healthcare clients. Sadiqa Mahmood, Senior VP for Medical Affairs, explains how Health Catalyst is building off their deep expertise analyzing clinical care data and adding to it the molecular data typically collected by pharma companies, biotechs, med device manufacturers, and even digital health companies in order to open up a new era of precision medicine. The idea is to enable these innovators to better define patient cohorts for targeted therapies by creating a more robust data-set that integrates clinical measures. Was this strategy part of Health Catalysts’ larger plan to go public? How have life sciences companies responded so far? Sadiqa gives us some insight on Health Catalyst’s growth plans.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

Burned out on Burnout?

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By SANJ KATYAL, MD

If you are like most doctors, you are sick of hearing about burnout. I know I am. There is a big debate on whether burnout is real or whether physicians are suffering from something more sinister like moral injury or human rights violations. That doesn’t matter. In the end, no matter what name we give the problem, the real issue is that physicians are in fact suffering. We are suffering a lot. Some of us—around one physician per day—are forced to alleviate their suffering by taking their own life. Each year, a million patients lose their physicians to suicide. Many more physicians suffer in silence and self-medicate with drugs or alcohol in order to function.

We are losing more physicians each year to early retirement or alternate careers. There are an increasing number of coaches and businesses whose single purpose is to help doctors find their side gigs and transition out of medicine. This loss comes at a time of an already depleted workforce that will contribute to massive physician shortages in the future. Perhaps even more troubling is that those physicians who remain in medicine are often desperate to get out. It is the rare physician these days that recommends a career in medicine to their own children. We now have a brain drain of the brightest students who would rather work on Wall Street than in a hospital. 

As a physician trained in positive psychology, I have been committed to helping other physicians and students improve their well-being. The focus on well-being is a welcome change in medicine.  But is it enough?

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