Category: Health

“Entrepreneurs Are Often Driven by Personal Experiences”

(p. B5) Eczema entrepreneurs are often driven by personal experiences that they or their family members have had with the skin condition. Joe Paulo, for example, created Smiling Panda clothing after he had eczema as a teenager.
. . .
Mr. Paulo, 23, has already made some inroads with adults seeking relief with his Smiling Panda brand, which he started after getting eczema on his arms. The eczema appeared after he moved from California to Philadelphia in 2012 to attend college.
His eczema, he said, “got significantly worse” when he had to wear professional clothing during college internships. When even bedsheets began irritating his skin, he started researching the properties of different fibers and how clothing was made. He chose a bamboo-cotton blend for his clothing because bamboo is soft and cotton fibers allow a closer fit, he said. He began cutting and stitching his own shirts, with flat seams and no tags.
When he wore his shirts to bed, he said: “I went from having a really tough time falling asleep to having no trouble at all.”
“I thought there might be other working adults interested in this type of clothing, and that comfortable clothing would help them in the same way it helped me,” he said. He found a small manufacturer willing to make a batch of sizes for women and men. He chose Smiling Panda as the company name and started a website in February 2016.
. . .
Mr. Paulo said he did not know if the company would ever be profitable. “I like doing it because I feel like our products make a difference in our customers’ lives,” he said. “I know from personal experience how miserable clothing can be when you are itching from eczema.”

For the full story, see:
Elizabeth Olson. “Personal Stories Drive Start-Ups In Eczema Products.” The New York Times (Thursday, July 20, 2017): B5.
(Note: ellipses added.)
(Note: the online version of the story has the date July 19, 2017, and has the title “‘The Beginning of a Wave’: A.I. Tiptoes Into the Workplace.”)

Drug Middlemen Create “Perverse Incentive” for Higher List Prices

(p. B1) The Department of Health and Human Services is scrutinizing the system of rebates and discounts paid to middlemen as medicine flows from manufacturers to patients. Those middlemen, such as drug wholesalers, pharmacies, and pharmacy-benefit managers, are often compensated as a percentage of a drug’s list price. That creates a perverse incentive for higher list prices throughout the system.
. . .
Pfizer , which made headlines earlier this month by pausing a slate of planned price increases due to White House criticism, sounds ready for reform. Chief Executive Ian Read on a conference call with analysts last week predicted that rebates are “going away” over the long term. Mr. Read added that the larger gaps between list and net prices amounted to a “subsidy” for companies in the drug supply chain and blamed those subsidies for the relatively weak sales of certain lower-priced versions of blockbuster drugs.

For the full commentary, see:
Charley Grant. ” HEARD ON THE STREET; Skies Darken for Drug Middlemen.” The Wall Street Journal (Wednesday, Aug. 8, 2018): B1.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Aug. 7, 2018.)

Dr. Charles Wilson Had Surgical Intuition, “Sort of an Invisible Hand”

(p. A19) Dr. Wilson sometimes worked in three operating rooms simultaneously: Residents would surgically open and prepare patients for his arrival, and he would then enter to seal an aneurysm or remove a tumor before moving on to the next case.
“He never spent much more than 30 or 60 minutes on each case, and we were left to close the case and make sure everything was O.K.,” Dr. Mitchel Berger, a former resident who is chairman of U.C.S.F.’s neurosurgical department, said in an interview. “It was unorthodox, but it worked. He demanded excellence and we gave him excellence.”
They also gave him silence. He allowed no music, no ringing phones and no idle chatter. Scrub nurses were expected to anticipate his requests.
“He would manage any break of silence with a stern look,” said Dr. Brian Andrews, a neurosurgeon who was one of Dr. Wilson’s residents and also his biographer, with the book “Cherokee Surgeon” (2011). (Dr. Wilson was one-eighth Cherokee.)
Dr. Wilson became world renowned for excising pituitary tumors through the sinus in a surgery called transsphenoidal resection.
. . .
The writer Malcolm Gladwell, in a profile of Dr. Wilson in The New Yorker in 1999, described one of those pituitary cancer surgeries. Looking at a tumor through a surgical microscope, Dr. Wilson used an instrument called a ring curette to peel the tumor from the gland.
“It was, he would say later, like running a squeegee across a windshield,” Mr. Gladwell wrote, “except that in this case, the windshield was a surgical field one centimeter in diameter, flanked on either side by the carotid arteries, the principal sources of blood to the brain.”
A wrong move could nick an artery or damage a nerve, endangering the patient’s vision or his life.
When Dr. Wilson saw bleeding from one side of the gland, he realized that he had not gotten all of the tumor. He found it and removed it. The surgery took only 25 minutes.
Dr. Wilson performed the surgery more than 3,300 times.
He told Mr. Gladwell that he had a special feel for surgery that he could not entirely explain.
“It’s sort of an invisible hand,” he said. “It begins almost to seem mystical. Sometimes a resident asks, ‘Why did you do that?’ ” His response, he told Mr. Gladwell, was to shrug and say, “Well, it just seemed like the right thing.”

For the full obituary, see:
Richard Sandomir. “‘Charles Wilson, 88, Lauded For Excising Brain Tumors, Sometimes Several in a Day.” The New York Times (Monday, March 5, 2018): A19.
(Note: ellipsis, and bracketed year, added.)
(Note: the online version of the obituary has the date March 2, 2018, and has the title “‘Charles Wilson, Top Brain Surgeon and Researcher, Dies at 88.”)

The biography of Wilson, mentioned above, is:
Andrews, Brian T. Cherokee Neurosurgeon: A Biography of Charles Byron Wilson, M.D. Scotts Valley, CA: CreateSpace Independent Publishing Platform, 2011.

When Volunteer Bystanders Save More Lives than So-Called First Responders

(p. A1) In the days after the shootings at the Route 91 Harvest festival in Las Vegas, many stories emerged of bystander courage. Volunteers combed the grounds for survivors and carried out the injured. Strangers used belts as makeshift tourniquets to stanch bleeding, and then others sped the wounded to hospitals in the back seats of cars and the beds of pickup trucks.
These rescue efforts took place before the county’s emergency medical crews, waylaid by fleeing concertgoers, reached the grassy field, an estimated half-hour or more after the shooting began. When they did arrive, the local fire chief said in an interview, only the dead remained.
“Everybody was treating patients and trying to get there,” Chief Gregory Cassell of the Clark County Fire Department, said of his personnel. “They just couldn’t.”
The experiences in Las Vegas have implications for the nation. Emergency medical services have changed how they respond to mass attacks, charging into insecure areas and immediately helping the injured rather than standing back. Still, every minute counts, and bystanders can play a critical role in saving lives, as shown in the aftermath to the shooting on Oct. 1 [2017] outside the Mandalay Bay Resort and Casino.
. . .
(p. A14) In Las Vegas, several factors impeded the arrival of emergency medical workers at the scene of the shooting itself.
Confusion abounded. One fire crew that happened to be passing by during the first few minutes saw people running from the festival and heard what sounded like gunfire. “You got reports of anything?” a member of the fire crew, Capt. Ken O’Shaughnessy of Engine 11, asked a dispatcher over the radio. “That’s a negative, sir,” he was told. Three minutes later, the dispatcher confirmed that there was an active call.
Members of that crew remained nearby, and later assisted injured concertgoers.
“From what it sounds like talking to them, they didn’t identify the hot zone because they didn’t know where it was,” said Mr. Cassell, the fire chief. “They just knew they had dozens and dozens of critical patients.”
More than 10 minutes after the shooting began, a battalion chief advised firefighters to “stage at a distance” and put on protective vests and helmets as he tried to understand the situation and make contact with a police lieutenant on the scene. The battalion chief radioed in seven minutes later that there were reports of gunfire at both the concert grounds and the Mandalay Bay across the street. “We can’t approach it yet,” he said.
The injured were already fleeing and being carried out in several directions. “Those crews making their way to the concert venue were met at every turn by patients in the streets,” Mr. Cassell said. The fire department helped establish several assembly points, and ultimately, about 160 firefighters and emergency medical workers from departments in the region went to the scene.
Inside the nearly empty concert grounds after the shooting stopped, some volunteers remained, roaming among the fallen near the stage, checking pulses and finding some of them unconscious but still breathing.

For the full story, see:
Sheri Fink. “‘First Medics on Scene in Las Vegas: Other Fans.” The New York Times (Monday, Oct. 15, 2017): A1 & A14.
(Note: ellipsis, and bracketed year, added.)
(Note: the online version of the story has the date Oct. 15, 2017, and has the title “‘After the Las Vegas Shooting, Concertgoers Became Medics.”)

The passages quoted above, provide one more example of one of the main messages of:
Ripley, Amanda. The Unthinkable: Who Survives When Disaster Strikes – and Why. New York: Crown Publishers, 2008.

Genetics Entrepreneur Compares FDA to DMV

(p. 1) MOUNTAIN VIEW, Calif. — In 2007, Anne Wojcicki, then 33, lassoed the moon.
She was getting her new company, 23andMe, a mail-order genetics testing firm, off the ground with her “Party ’til you spit” celebrity get-togethers.
She married Sergey Brin, the cute co-founder of Google, also 33 and already one of the richest men in America, at a top-secret Esther Williams extravaganza in the Bahamas. The bride in a white bathing suit and the groom in a black one, they swam to a sandbar in the Bahamas and got hitched in the middle of the sparkling aquamarine ocean.
Soon after the marriage, as Mr. Brin accumulated more power, a yacht, and a fleet of jets, Ms. Wojcicki became pregnant with the first of their two children and Google invested millions in her start-up, named after the 23 paired chromosomes that consist of our DNA.
But six years later, the Silicon Valley fairy tale was shattered by two public humiliations: Mr. Brin got involved with a beautiful young Englishwoman named Amanda Ro-(p. 12)senberg, who provided a public face for Google Glass — an attachment that broke up his marriage. And the Food and Drug Administration shut down the primary function of Ms. Wojcicki’s business, calling her D.N.A. spit vial “an unapproved medical device” and imposing stricter rules for consumer genetic testing. Her business, once so ripe with promise to tackle health issues, was curtailed to its ancestry testing division.
. . .
“In some ways, when you have that many bad things happen, it’s a sense of disbelief,” she says. “This was one of those situations where there’s two aspects. A divorce and the F.D.A. There was no workaround in either. So it was one of the first times in my life where you have to accept, you have to actually change. Like, I need to come up with a different way of approaching both of these relationships.”
. . .
(p. 13) She’s focused for now on her children, her new Bengal cats and her company, which has more than three million customers and its own drug-development program. It started selling kits in CVS and Target, got the F.D.A.’s permission to resume giving consumers health reports on 10 conditions, including Parkinson’s and Alzheimer’s, and the $99 ancestry kit won a spot as one of “Oprah’s favorite things” this year, with Oprah calling it “The Ultimate Selfie.” Fast Company portrayed Ms. Wojcicki as the Comeback Kid of tech.
She realized that she had a treasure trove of DNA data and began teaming with Genentech and Procter & Gamble, which started mining it to make breakthroughs in Parkinson’s, depression and skin care.
In many ways, her struggle with the F.D.A. was a microcosm of the increasingly tense battle between hidebound regulatory agencies and freewheeling tech companies.
Although some people thought Ms. Wojcicki would have to sell her company, she healed the breach with the F.D.A. the same way she healed the breach with Mr. Brin. She did not huff away and seethe and backbite. She “put one foot ahead of the other,” as her mother advises, hired the best regulatory experts and found a respectful new configuration for the relationship.
“We were not communicating in the right way,” she says of the period the F.D.A. felt it was being ignored. “We were not showing Silicon Valley arrogance. We just were running around with our shoes on in a Japanese house. We were not a cultural fit and we weren’t expressing what we were trying to do in the right way.
“Some companies are trying to circumvent the regulators. We weren’t. We just got caught in the cross hairs. We clearly pissed them off. It took us a long time to generate a lot of data to prove that our intentions actually were right. But I feel like we’re doing the right thing in terms of proving that the customer is capable of getting this information on their own.
“I see it from the F.D.A. perspective. It’s a new product. It’s genetics. It’s direct to consumer. It caused anxiety. So, you know, the onus was on us.”
She had to explain to her team: “Listen, when you go to the D.M.V., you don’t argue about the vision test. You don’t say, ‘Oh, I just had a vision test. I don’t need to do the vision test.’ Like, you just do it. The F.D.A. is in charge of public safety, and I have a respect for the job that they have to do. And we’re just going to do the job that they’re asking us to do.”

For the full story, see:
Maureen Dowd. “‘Adapt and Evolve.” The New York Times, SundayStyles Section (Sunday, Nov. 19, 2017): 1 & 12-13.
(Note: ellipses added.)
(Note: the online version of the story has the date Nov. 18, 2017, and has the title “‘The Doyenne of DNA Says: Just Chillax With Your Ex.”)

Dog Research on Muscular Dystrophy Can Lead to Cures for Both Dogs and Humans

(p. A13) Researchers used a gene-editing tool to repair a gene mutation in dogs with Duchenne muscular dystrophy, an important step in efforts to someday use the tool to edit DNA in people with the same fatal disease.
In a study published Thursday [Aug. 30, 2018] in the journal Science, researchers at UT Southwestern Medical Center in Dallas and the Royal Veterinary College in London reported that they used the Crispr gene-editing system in four dogs to restore production of dystrophin, a protein crucial for healthy muscle function.
. . .
“It’s like putting a good spare tire on a car. It’s not as good as the original, but it gets you where you want to go,” said Eric Olson, director of UT Southwestern’s Hamon Center for Regenerative Science and Medicine and senior author of the paper.
Dr. Olson, who is also founder and chief scientific adviser of Exonics Therapeutics Inc., which licensed the technology from UT Southwestern and helped fund the dog studies, said next steps involve testing Crispr in more dogs and observing them for a year or more. If the approach works in the dogs, he said researchers hope to try Crispr in a clinical trial with people with Duchenne.

For the full commentary, see:
Amy Dockser Marcus. “Gene Editing Shows Promise for Muscular Dystrophy.” The Wall Street Journal (Friday, Aug. 31, 2018): A13.
(Note: ellipsis, and bracketed date, added.)
(Note: the online version of the commentary has the date Aug. 30, 2018, and has the title “Crispr Used to Repair Gene Mutation in Dogs With Muscular Dystrophy.”)

The study in Science, that is mentioned above, is:
Amoasii, Leonela, John C. W. Hildyard, Hui Li, Efrain Sanchez-Ortiz, Alex Mireault, Daniel Caballero, Rachel Harron, Thaleia-Rengina Stathopoulou, Claire Massey, John M. Shelton, Rhonda Bassel-Duby, Richard J. Piercy, and Eric N. Olson. “Gene Editing Restores Dystrophin Expression in a Canine Model of Duchenne Muscular Dystrophy.” Science (Aug. 30, 2018), DOI: 10.1126/science.aau1549. [Epub ahead of print]

Cancer Cure Progress Has Been “Painfully Incremental”

(p. A15) Hopes were high in 1971 when President Richard M. Nixon called for a War on Cancer. The disease was as pernicious as it was mysterious, claiming more American lives each year in the 1960s than had perished in combat during all of World War II. Still, it wasn’t hard to imagine medical experts coming up with a cure. After all, hadn’t the country just put a man on the moon?
Almost 50 years later, the war rages on. Decades of hard work and grand promises have yielded more disappointments than breakthroughs. Reliable treatments remain elusive, and researchers still aren’t sure why some people get the disease and others don’t, why some die while others survive. In “Cancerland: A Medical Memoir,” David Scadden offers a personal account of the inspiring but often exasperating hunt for solutions to the profound problem of cancer.
. . .
. . . moving science forward “to create better clinical approaches,” Dr. Scadden writes, “is an almost painfully incremental affair.” This puts physicians in the awkward position of having to explain the slow pace of research to dying patients, many of whom hope that a miraculous new drug or therapy awaits them if they can just hold on for another year or two. This is not a crazy idea. Dr. Scadden’s own mother, who died of colon cancer in 1985, might have survived if certain studies were completed five years sooner. But most clinical trials come to nothing, particularly in cancer. Many patients are stuck with the same interventions that have been around for decades: surgery, radiation and toxic chemotherapy. The miserable side effects can sometimes make life only marginally better than death.

For the full review, see:
Emily Bobrow. “BOOKSHELF; Reason to Hope.” The Wall Street Journal (Thursday, Aug. 2, 2018): A15.
(Note: ellipses added.)
(Note: the online version of the review has the date Aug. 1, 2018, and has the title “BOOKSHELF; ‘Cancerland’ Review: Reason to Hope.”)

The book under review, is:
Scadden, David, and Michael D’Antonio. Cancerland: A Medical Memoir. New York: Thomas Dunne Books, 2018.

Uncredentialed Entrepreneur Innovated to Save Babies

(p. 1A) He showed up in Omaha 120 summers ago, another unknown showman hoping to make a name for himself at this city’s biggest-ever event, its world’s fair.

He gave his name as Martin Couney, or sometimes Martin Coney. It wasn’t, at least not yet.
He said he was a doctor, a European doctor, a protégé of the world’s finest doctors. He was none of these things.
And yet in Omaha, Dr. Couney set up shop in a little white building on the east midway, not far from the Wild West Show, the Middle Eastern dancers, the roaming fortune tellers and the Indian Congress starring a Native American chief named Geronimo.
The fair, officially known as the Trans-Mississippi and International (p. 2A) Exposition, showcased all manner of things seen as strange, exotic and otherworldly to the 2 million Nebraskans and visitors paying the 50-cent admission to have their minds blown in the summer of 1898.
Couney thought he had just the thing to blow their minds.

“Infant Incubators with Living Infants” read the sign above the entrance.

“A Wonderful Invention … Live Babies” said another.
. . .
Usually the experts are right. That’s why they are experts,” says Dawn Raffel, author of the “The Strange Case of Dr. Couney,” a new biography seeking to save this once-famed faux doctor from history’s trash bin. “But occasionally you get an outlier like this. Someone who is extraordinarily inventive. Who brings us something incredible.”
What Dr. Couney gave us, through decades of work and tireless promotion, was an understanding that we could save babies that since the beginning of time had died before they crawled. We could save them using a piece of equipment designed by a French engineer who realized that if an egg could be nurtured in an incubator, then so could a newborn.
. . .
Newspapers, including The World-Herald, largely ignored the exhibit, Raffel says. The public didn’t seem particularly bothered that a “doctor” had decided to house anonymous newborns on the fairgrounds and put them on public display.
They also didn’t seem particularly interested, either.
. . .
Raffel estimates that Couney and his doctors and nurses saved between 6,500 and 7,000 premature babies all on their own during decades of midway work. But they saved countless thousands more by raising the profile of premature babies. By raising the hope that they could grow into healthy, happy adults.
. . .
“I find him fascinating because he was such a complicated man,” Raffel says. “He deserves more credit.”

For the full story, see:
Hansen, Matthew. “Tech Costs Force Honda To Let Go of Engineering Legacy.” Omaha World-Herald (Friday, Aug. 3, 2018): 1A-2A.
(Note: ellipses between paragraphs, added; ellipsis internal to sentence, in original.)

The Raffel book on which the passages quoted are partially based, is:
Raffel, Dawn. The Strange Case of Dr. Couney: How a Mysterious European Showman Saved Thousands of American Babies. New York: Blue Rider Press, 2018.

Cancer Five-Year Survival Rates Still Discourage

I quote the discouraging cancer survival numbers below because too often “Cancer Inc.” allies itself with government regulators to slow the disruptive medical entrepreneurs who who would otherwise quickly make those numbers less discouraging.

(p. A15) Cancer Treatment Centers of America– . . . –has long raised eyebrows with its marketing. Currently, the group touts its “genomic testing,” which guides patient-specific chemotherapy. Unmentioned is the dismal success rate of such tests in trials: Only 6.4% of patients were successfully matched with a drug, according to a 2016 article in Nature.
Here, from the American Cancer Society, are five-year survival statistics for various cancers: cervical, 69%; leukemia, 63%; ovarian, 46%; brain and nervous system, 35%; lung, 19%; liver, 18%; pancreatic, 9%.
One wonders how such numbers justify the blue sky seen in today’s advertising.
. . .
. . . the war on cancer is not the place for pep talks and poetic license. We could do with more disclosure, less delusion.
Nor is this a question of depriving patients of hope. On the contrary, it’s about depriving Cancer Inc. of the ability to exploit false hope.

For the full commentary, see:
Steve Salerno. “In the War on Cancer, Truth Becomes a Casualty; The multibillion-dollar treatment industry appeals to emotion in misleading ads.” The Wall Street Journal (Saturday, April 21, 2018): A15.
(Note: ellipses added.)
(Note: the online version of the commentary has the date April 20, 2018.)

Entrepreneur Was Frustrated by Patients’ Pill Confusion

(p. B2) TJ Parker grew up working the counter for his father’s pharmacy in Concord, N.H., where he became frustrated by how much customers struggled to keep track of their medications.
He went to pharmacy school but rather than take up the family business, he and a friend set out to change it. In 2013, they launched an online pharmacy from Manchester, N.H. On Thursday, the 32-year-old CEO said he sold his startup to Amazon.com Inc. It was a roughly $1 billion deal, according to people familiar with the deal. Mr. Parker is expected to stay involved after the deal, said a person familiar with the matter.
. . .
One of the company’s earliest investors, David Frankel of Boston-based Founders Collective, wrote in a post on the website Medium Thursday that the company showed promise with two founders that complement each other.
“TJ cherishes beautiful design but has the bearing of a doctor,” he wrote of Mr. Parker, while Mr. Cohen was able to master the technical challenges behind an “indispensable pill dispensing solution.”
. . .
While attending the Massachusetts College of Pharmacy and Health Sciences in Boston, he started taking fashion-design classes at the nearby Massachusetts College of Art. “Pharmacy school was sooo boring,” he said in the interview.
His design-school stint was short-lived, but the expertise, he said, inspired PillPack’s concept of simplifying medication regimens by sorting pills into so-called “dose packets,” dispensed from a small box in baggies marked with the date and time they are to be taken.
It turned out to be a billion-dollar idea.

For the full story, see:
Eliot Brown and Sharon Terlep. “Frustrated Pharmacist Came Up With PillPack.” The Wall Street Journal (Friday, June 29, 2018): B2.
(Note: ellipses added.)
(Note: the online version of the story has the date June 28, 2018, and has the title “Behind PillPack’s $1 Billion Sale, a Frustrated 32-Year-Old Pharmacist.”)

“It’s Time for the FDA to Get with the Program”

(p. A14) Are eggs good for you or not?
It’s never been more confusing for consumers to answer that seemingly simple question. Vilified for years for their high cholesterol content, eggs more recently have broken back into dietary fashion. Nutrition experts today are touting eggs’ high levels of protein, essential vitamins and nutrients like brain-booster choline.
Government guidelines sometimes contradict nutrition experts’ advice as they play catch up with the latest scientific findings. Dietary advice from the U.S. departments of agriculture and health and human services includes eggs as part of a healthy diet, but also says cholesterol intake should be as low as possible. And the Food and Drug Administration says that eggs are too high in total fat, saturated fat and cholesterol to be labeled “healthy” by food marketers.
It’s such a scrambled issue that one egg brand is petitioning for an official government reassessment of eggs. “There’s so much new science out there about eggs, it’s time for the FDA to get with the program,” says Jesse Laflamme, chief executive of Pete and Gerry’s Organics, who filed a citizen’s petition urging the agency to rethink its ban on calling eggs “healthy.”

For the full commentary, see:
Ellen Byron. “The Great Egg Conundrum.” The Wall Street Journal (Wednesday, June 13, 2018): A14.
(Note: the online version of the commentary has the date June 12, 2018, and has the title “The Great Egg Debate: Are They Healthy or Not?”)