In Part I of this series, we learned that there is a new cancer screening test that has shown the ability to detect cancers earlier than possible before, which has led to more effective treatment. Roger Royse, a lawyer in California, had the test which detected early pancreatic cancer, which is usually detected late when it is routinely fatal. But because his cancer was detected early, he had successful treatment and is now cancer free.

Allysia Finley, writing in The Wall Street Journal, tells us this happy ending was only made possible, however, because Mr. Royse was willing to pay for the test out of his own pocket, because insurance wouldn’t pay for it. Which leads to the obvious question, why not?

The test is relatively expensive at $949, but this is cheap compared to other tests that are routinely done, like MRI scans, which usually cost thousands. The test, called Galleri, is produced by a company called Grail.

Grail’s test has a roughly 0.5% false-positive rate, meaning 1 in 200 patients who don’t have cancer will get a positive signal. Its positive predictive value is 43%, so that of every 100 patients with a positive signal, 43 actually have cancer. That may sound low, but the positive predictive value for some recommended cancer screenings is far lower. Fewer than 1 in 10 women with an abnormal finding on a mammogram are diagnosed with breast cancer.

Because Grail uses machine learning to detect DNA-methylation cancer linkages, the Grail test’s accuracy should improve as more tests and patient data are collected. Dr. Ofman says the company also aims to reduce the test’s cost by scaling up manufacturing and detecting cancers with less genetic sequencing.

But therein lies a chicken-and-egg problem. Patient access is limited by Galleri’s lack of Food and Drug Administration approval and insurance coverage. These could help reduce the test’s costs and improve its accuracy. But regulators may balk at approving the test, and insurers at covering it, until it becomes cheaper and more reliable.

Regulators classify Galleri as a lab-developed test. Such tests are overseen by the Centers for Medicare and Medicaid Services and can be prescribed without FDA approval. This regulatory pathway allows hospitals, research centers and startups to develop tests without running the FDA’s bureaucratic gantlet. Since diagnostic tests can’t injure patients, no safety review is necessary.

The FDA in October proposed regulating lab-developed tests as medical devices, which generally require agency approval. That could severely curtail patient access and slow test development since the FDA doesn’t have the personnel to evaluate the tens of thousands of lab-developed tests on the market. The rule’s public comment period closed on Dec. 4.

Finley says, “Requiring randomized controlled trials and FDA approval for multicancer early-detection tests could restrict access for years. Hundreds of thousands of patients would likely have to be enrolled in trials, some receiving the test with the others in a control group. They would have to be followed over many years to determine whether patients who received the test were diagnosed with specific cancers earlier than those in the control group and how much longer they lived as a result. Proving a statistically significant benefit could take a decade or longer.”

One alternative is to rely on real-world studies, which Grail is already doing. One study of patients 50 and older without signs of cancer showed that the test doubled the number of cancers detected. The FDA could also approve the test, and CMS could provide Medicare coverage, on the condition that providers collect patient data that can be used to analyze the benefits.

Dana Goldman, the University of Southern California’s dean of public policy, likes that idea: “There will be a lot of suffering if we have to wait 10 years for the tests to be approved.” Mr. Goldman has spent decades studying the economics of medical treatments. One recurring problem he has seen: “Epidemiologists are always getting cancer wrong,” he says. “Epidemiologists a decade ago said U.S. overtreats cancers. Well, no, the EU undertreats cancer.”

A 2012 study that he co-authored found that the higher U.S. spending on cancer care relative to Europe between 1983 and 1999 resulted in significantly higher survival rates for American patients than for those in Europe. By his study’s calculation, U.S. spending on cancer treatments during that period resulted in $556 billion in net benefits owing to reduced mortality.

He expects Galleri and other multicancer early-detection tests to reduce deaths and produce public-health and economic benefits that exceed their monetary costs. Cancers caught early are cheaper to treat—less likely to require a cocktail of expensive therapies, and in some cases removable without the need for chemotherapy.

Let’s hope this test is approved by private insurance and Medicare soon. We need all the early detection cancer screening tests we can get!

Cancer treatment has come a long way from where it was in 1975 when I entered medical school. But success is still mainly dependent upon early detection. With early detection, the cure rate for many cancers is exceedingly high. Therefore, who wouldn’t want to improve our ability to detect cancers early?

Allysia Finley, writing for The Wall Street Journal, tells us of the dramatic case of Roger Royse, who was diagnosed with pancreatic cancer in July, 2022. But unlike most people, Royse was diagnosed in Stage II, with limited disease, instead of Stage IV. The five-year relative survival rate for late-stage metastatic pancreatic cancer is 3% – which means that patients are 3% as likely to live five years after their diagnosis as other cancer-free individuals. But if pancreatic cancer is caught before it has spread to other organs, the survival rate is 44%.

The trouble is that this cancer is almost never caught early. There’s no routine screening for it, and symptoms don’t develop until it is advanced. Mr. Royse, 64, had no idea he was sick until he took a blood test called Galleri, produced by the Menlo Park, Calif., startup Grail. He had surgery and chemotherapy and is now cancer-free.

Early diagnosis is the best defense against most cancers, as President Biden noted when he announced his Cancer Moonshot initiative two years ago. But only a handful of cancers—of the breast, lung, colon and cervix—have screening tests recommended by the U.S. Preventive Services Task Force, an independent panel that evaluates medical screenings.

Many companies are developing blood tests that can detect cancer signals before symptoms occur, and Grail’s is the most advanced. A study found it can identify more than 50 types of cancer 52% of the time and the 12 deadliest cancers in Stages I through III 68% of the time.

Naturally, it’s expensive. The test costs $949 and isn’t covered by Medicare or most private insurance. Mr. Royse, a lawyer who works with Silicon Valley startups, paid out of pocket for the test and follow-up imaging to confirm his cancer. Most Americans can’t afford to do so, and some public-health experts think that’s just as well. They fret that widespread use of multicancer early-detection tests would cause healthcare spending to explode. Those fears have snarled Galleri and similar tests in a web of red tape.

Mr. Royse learned about Grail’s test in April 2022 and asked his physician about it. “He said it was unnecessary, and you don’t have symptoms,” Mr. Royse says. A second doctor also refused to prescribe it. So Mr. Royse visited Grail’s website, which referred him to a telemedicine provider who ordered a test. Another telemedicine doctor walked him through his results, which showed a cancer signal likely emanating from the pancreas, gallbladder, stomach or esophagus.

An MRI revealed a suspicious mass on his pancreas, which a biopsy confirmed was cancerous. Mr. Royse had three months of chemotherapy, surgery and another three months of chemotherapy, which ended last February. Because pancreatic cancer often recurs, he gets CT and MRI scans every three months. In addition, he has signed up for startup Natera’s Signatera customized blood test, which checks DNA specific to the patient’s cancer and can signal its return before signs are visible on the scans.

Grail’s test has a roughly 0.5% false-positive rate, meaning 1 in 200 patients who don’t have cancer will get a positive signal. Its positive predictive value is 43%, so that of every 100 patients with a positive signal, 43 actually have cancer. That may sound low, but the positive predictive value for some recommended cancer screenings is far lower. Fewer than 1 in 10 women with an abnormal finding on a mammogram are diagnosed with breast cancer. Yet all women over 40 are advised to get regular mammograms.

What is hampering the widespread use of this new form of cancer screening?

More on that next post.

This blog is about healthcare; all forms of healthcare. I guess that even includes empty nest coaching. Wait, I know right about now you’re wondering, “What’s an empty nest coach?” I’m glad you asked because this post is all about them.

Tara Weiss, writing in The Wall Street Journal, says there’s a new occupation out there now for those looking to help parents adjust to the emptiness of their house when their children leave home. Weiss says, “Helicopter parents get accustomed to tracking their children’s every move via smartphone, keeping activities tightly scheduled, scrutinizing homework and grades, exchanging miles of texts. For a certain cohort of hands-on parents, getting their teens into college marks the finish line. Then comes the coup de grâce. ‘Bye, Mom! Bye, Dad! See you at Thanksgiving!’”

She says the kids are fine, but the parents are now the ones who need help. The exit of high-school seniors leaves many feeling like “they’re being fired from a job they’ve had for 18 years,” says Jason Ramsden, who has made a name for himself on TikTok as “The Empty Nest Coach.”

It seems this new occupation is a growing livelihood – with training certification, support groups and $250-an-hour private-counseling sessions. Demand is driven by parents who feel an emotional and logistical vacuum after years of shepherding children from one moment to the next.

Kenny Hayslett recalled bittersweet feelings when his oldest child left for college. But he didn’t expect the profound sadness when his middle child said goodbye last year. “They all sting, but this one hurt,” the 56-year-old said. “Even though you know it’s coming to an end, it is such a shock,” said Ramsden, who ushered his last child out the door a little more than two years ago. TikTok’s algorithm, sensing Hayslett’s pain when his second child left for college last year, served one of Ramsden’s empty-nester videos. Hayslett, of Clearwater, Fla., said he felt like “this dude is talking right to me. I can’t believe this is a thing.” He paid Ramsden $2,000 for weekly videoconferences over about three months before Camden left for college.

Weiss tells us, like other things no longer taboo—from getting fired to not wearing pants—empty-nesters want to talk about their struggle. Ramsden has drawn more than 50,000 subscribers to his TikTok account since becoming a certified coach in 2022. Elsewhere on the internet, the Facebook group Empty Nest Moms has more than 12,000 members seeking guidance and assurance from others in the same emptied boat. The Inspired Empty Nest, an online community started by empty-nester Bobbi Chegwyn, offers to connect local parents seeking to commiserate about the sudden silence at home.

Executive and life coaching were popular specialties when Valorie Burton, CEO of the Coaching and Positive Psychology Institute in Atlanta, began in 2002. In past years, she said, coaching services have widened to people going through a divorce or career change. Training can last a weekend or as long as six months, teaching coaches to help clients set goals and carry them out.

Empty-nesters get plenty of unsolicited advice from friends and family: Get a job. Get a hobby. Get a life. Empty-nest coaches say such suggestions aren’t helpful first steps. “They need to grieve,” said empty-nest coach Natalie Caine. She became a $250-an-hour certified coach in Los Angeles following her own entry into empty-nesthood 15 years ago. “I get asked all the time,” Caine said, “‘Do other parents feel like this?’”

Camden Hayslett said he wasn’t surprised his father was sad about him leaving for college. The only time he ever saw him cry was when the family said goodbye to his older brother after they dropped him at school. What he didn’t see coming was his dad hiring an empty-nest coach. Camden thinks it has helped. It doesn’t hurt that he talks with dad every day. “That’s something that makes him feel more in the loop,” he said.

I’m probably the least qualified person to comment on this subject since my wife and I are not parents. I’m sure my parents weren’t looking for an “empty nest coach” when I went off to college 2000 miles away – they were probably celebrating! But this sounds like another indicator that some people just have too much money and too much time on their hands.