Category: Health

Neighborhood Center Delivered the Air-Conditioning that NYC Had Promised

(p. A7) It seemed like a noble idea to offer quick help during the pandemic: New York City would give away free air-conditioners this summer to low-income older people who are stuck indoors.

It turned out to be a far more complicated mission for the city.

. . .

The difficulty in getting a free air-conditioner left many seniors frustrated and confused by what they described as a bureaucratic, inefficient process.

Concepcion Reyes, who is 67 and has asthma, said she made numerous phone calls to a handful of city agencies from her stuffy apartment last week, after seeing her neighbor snag a free air-conditioner from the city.

“I’ve been in the shower two times already today,” Ms. Reyes, who lives at Holmes Towers, a public housing building on the Upper East Side of Manhattan, said last week. “I’m sweating bullets.”

. . .

Frustrated by delays, officials at the Stanley M. Isaacs Neighborhood Center in Manhattan spent nearly $30,000 on 56 air-conditioners for older people.

Rosalina Acevedo, who is 73 and diabetic, had one of the units installed in her bedroom at Holmes Towers in July [2020]. When she turned it on for the first time, she instantly felt relief.

“It was delicious,” she said.

Gregory J. Morris, the center’s executive director, said the city should have worked with community groups that could easily have provided a list of older residents with serious health conditions who urgently needed the units. The city had its own lists, and names were missing.

“They were desperate,” he said of the older people his center works with. “There was no timeline from the city. If you’re in the middle of a heat wave, do I wait longer for the city? Or do I step in and solve the problem?”

For the full story, see:

Emma G. Fitzsimmons. “The Wait for Promised Air-Conditioners Leaves Some Older Residents Sweating.” The New York Times (Saturday, August 22, 2020): A7.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story has the date Aug. 21, 2020, and has the title “Older New Yorkers Sweat It Out, Waiting for Promised Air-Conditioners.”)

Asymptomatic Transmission of Covid-19 Reduces Value of Fever Checks

(p. A4) . . . while health officials have endorsed masks and social distancing as effective measures for curbing the spread of the coronavirus, some experts scoff at fever checks. Taking temperatures at entry points is nothing more than theater, they say, a gesture that is unlikely to screen out many infected individuals, and one that offers little more than the illusion of safety.

. . .

. . . a growing body of evidence suggests that many of those who are driving transmission are so-called silent carriers — people who have been infected but feel fine, and don’t have a fever or any other symptoms.

. . .

“We now have a better understanding of Covid-19 transmission that indicates symptom-based screening has limited effectiveness because people with Covid-19 may have no symptoms or fever at the time of screening, or only mild symptoms,” the C.D.C. said in a statement.

. . .

Evidence of asymptomatic spread dates back to early in the pandemic, but has been mounting ever since. A recent study from South Korea published in JAMA Internal Medicine in August offered even more proof, finding that infected individuals who don’t feel ill may carry just as much virus in their nose, throat and lungs as those with symptoms — and for almost as long.

. . .

A. David Paltiel, a professor of health policy and management at Yale School of Public Health, says these individuals are the “silent spreaders” who are driving transmission and sparking superspreading events.

“You are maximally infectious before you exhibit symptoms, if you exhibit any symptoms at all,” Dr. Paltiel said. “You can be exposed and incubating the virus, and be beginning to shed massive amounts of transmissible virus and be a superspreader, without actually exhibiting any symptoms like a fever.”

For the full story, see:

Roni Caryn Rabin. “Fever Checks Are on the Rise, but Are They Effective Gatekeepers?” The New York Times (Monday, September 14, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated September 14, 2020, and has the title “Fever Checks Are No Safeguard Against Covid-19.”)

The paper in JAMA Internal Medicine discussed above is:

Lee, Seungjae, Tark Kim, Eunjung Lee, Cheolgu Lee, Hojung Kim, Heejeong Rhee, Se Yoon Park, Hyo-Ju Son, Shinae Yu, Jung Wan Park, Eun Ju Choo, Suyeon Park, Mark Loeb, and Tae Hyong Kim. “Clinical Course and Molecular Viral Shedding among Asymptomatic and Symptomatic Patients with Sars-Cov-2 Infection in a Community Treatment Center in the Republic of Korea.” JAMA Internal Medicine (published online in advance of print Aug. 6, 2020). Doi:10.1001/jamainternmed.2020.3862

Older Men Produce Fewer T-Cells Than Older Women

(p. A7) The coronavirus may infect anyone, young or old, but older men are up to twice as likely to become severely sick and to die as women of the same age.

Why? The first study to look at immune response to the coronavirus by sex has turned up a clue: Men produce a weaker immune response to the virus than do women, the researchers concluded.

The findings, published on Wednesday [Aug. 26, 2020] in Nature, suggest that men, particularly those over age 60, may need to depend more on vaccines to protect against the infection.

“Natural infection is clearly failing” to spark adequate immune responses in men, said Akiko Iwasaki, an immunologist at Yale University who led the work.

. . .

Over all, the scientists found, the women’s bodies produced more so-called T cells, which can kill virus-infected cells and stop the infection from spreading.

Men showed much weaker activation of T cells, and that lag was linked to how sick the men became. The older the men, the weaker their T cell responses.

“When they age, they lose their ability to stimulate T cells,” Dr. Iwasaki said. “If you look at the ones that really failed to make T cells, they were the ones who did worse with disease.”

For the full story, see:

Apoorva Mandavilli. “New Clue on Why Men Are Hit Harder.” The New York Times (Thursday, August 27, 2020): A7.

(Note: ellipsis, and bracketed date, added.)

(Note: the online version of the story was updated Aug. 27 [sic], 2020, and has the title “Why Does the Coronavirus Hit Men Harder? A New Clue.”)

The paper in Nature discussed above is:

Takahashi, Takehiro, Mallory K. Ellingson, Patrick Wong, Benjamin Israelow, Carolina Lucas, Jon Klein, Julio Silva, Tianyang Mao, Ji Eun Oh, Maria Tokuyama, Peiwen Lu, Arvind Venkataraman, Annsea Park, Feimei Liu, Amit Meir, Jonathan Sun, Eric Y. Wang, Arnau Casanovas-Massana, Anne L. Wyllie, Chantal B. F. Vogels, Rebecca Earnest, Sarah Lapidus, Isabel M. Ott, Adam J. Moore, Kelly Anastasio, Michael H. Askenase, Maria Batsu, Hannah Beatty, Santos Bermejo, Sean Bickerton, Kristina Brower, Molly L. Bucklin, Staci Cahill, Melissa Campbell, Yiyun Cao, Edward Courchaine, Rupak Datta, Giuseppe DeIuliis, Bertie Geng, Laura Glick, Ryan Handoko, Chaney Kalinich, William Khoury-Hanold, Daniel Kim, Lynda Knaggs, Maxine Kuang, Eriko Kudo, Joseph Lim, Melissa Linehan, Alice Lu-Culligan, Amyn A. Malik, Anjelica Martin, Irene Matos, David McDonald, Maksym Minasyan, Subhasis Mohanty, M. Catherine Muenker, Nida Naushad, Allison Nelson, Jessica Nouws, Marcella Nunez-Smith, Abeer Obaid, Isabel Ott, Hong-Jai Park, Xiaohua Peng, Mary Petrone, Sarah Prophet, Harold Rahming, Tyler Rice, Kadi-Ann Rose, Lorenzo Sewanan, Lokesh Sharma, Denise Shepard, Erin Silva, Michael Simonov, Mikhail Smolgovsky, Eric Song, Nicole Sonnert, Yvette Strong, Codruta Todeasa, Jordan Valdez, Sofia Velazquez, Pavithra Vijayakumar, Haowei Wang, Annie Watkins, Elizabeth B. White, Yexin Yang, Albert Shaw, John B. Fournier, Camila D. Odio, Shelli Farhadian, Charles Dela Cruz, Nathan D. Grubaugh, Wade L. Schulz, Aaron M. Ring, Albert I. Ko, Saad B. Omer, Akiko Iwasaki, and Impact research team Yale. “Sex Differences in Immune Responses That Underlie Covid-19 Disease Outcomes.” Nature (published online in advance of print Aug. 26, 2020). DOI: https://doi.org/10.1038/s41586-020-2700-3

How “Blind” Is a Double-Blind Trial When Volunteers Know the Side-Effects of the Vaccine?

(p. A8) George Washington University had vaccinated 129 people since its share of the trials started. I would be No. 130. Altogether, Moderna planned to enroll 30,000 people in its trial. Half would be given the actual vaccine and half would get the placebo. The protocol called for two shots spaced a month apart.

Finally, it was time for my injection, which is when things got a little weird.

“We have to leave you now, because this is a double-blind study and we are blinded,” Dr. Malkin said. “You’ve been randomized.”

Before I could ask her to translate what she had just said, she was gone, and two nurses arrived with my vaccine. The first nurse left, and the second nurse, Linda Witkin, asked whether I was right-handed or left-handed, then proceeded to inject my right arm.

“Which one are you giving me, the vaccine or the placebo?” I asked. She gave me a look, clearly not pleased with my questioning.

. . .

With the Moderna trial, the side effects reported so far have been typical: fever, chills, muscle and joint soreness.

. . .

The night after my shot, I took my temperature: 97.5. I felt under my arms for glandular swelling and felt only mild joint pain.

. . .

“You all gave me the placebo, didn’t you?” I demanded of Dr. Diemert on Wednesday, during my one-week checkup. “I cannot believe I went through all of this and got the placebo.”

He told me that the actual vaccine shot was more “viscous” than the placebo, which was why neither he nor Dr. Malkin could be in the room when I got it, because they would have been able to easily determine. And so he really couldn’t answer because the double-blind program is meant to protect doctors like him from patients like me. He said I wasn’t to badger Ms. Witkin, if I ever even saw her again. He also said that most people reacted more to the second shot than the first one.

I texted the peanut gallery, “I feel no different.”

For the full story, see:

Helene Cooper. “From Reporting on Ebola to Being a Volunteer in a Covid-19 Vaccine Trial.” The New York Times (Saturday, September 12, 2020): A8.

(Note: ellipses added.)

(Note: the online version of the story has the date Sep. 11, 2020, and has the title “Covering Ebola Didn’t Prepare Me for This: I Volunteered for the Covid-19 Vaccine Trial.”)

Quick, Less Precise, but Repeated, Covid-19 Tests Can Be Better Than Slow Precise Tests

(p. A1) Public health experts are increasingly calling for a shift in thinking about Covid-19 testing: It is better to get fast, frequent results that are reasonably accurate than more precise results after dayslong delays.

. . .

Covid-19 tests that don’t require a lab tend to be less sensitive than “gold standard” laboratory-based tests, meaning they are likely to miss more cases. But many public health experts now say that repeat testing can make up for the loss of sensitivity, and such testing could quickly identify the most infectious people and help bring transmission to heel as workplaces and schools resume in-person operations and as influenza season looms.

. . .

(p. A6) “When we looked ahead, we realized we needed a paradigm shift from the still-needed diagnostic tests to the screening tests,” said Jonathan Quick, managing director for pandemic response, preparedness and prevention at the Rockefeller Foundation, which released a report in July [2020] calling for a massive scale-up in quick, cheap tests for Covid-19 screening. “As a practical matter, that meant making much more of a new kind of test,” Dr. Quick said.

Most Covid-19 diagnostic testing in the U.S. is processed in laboratories and uses a technique called rt-PCR that searches for the virus’s genetic material and amplifies it. The tests are incredibly sensitive but expensive to run, and the process often requires shipping samples from a test site to a lab.

. . .

“I think there’s a sense of desperation that we need to do something else,” Ashish Jha, dean of Brown University’s School of Public Health, said at a media briefing in August [2020].

. . .

Antigen tests are better at identifying cases when people have more virus in their system—meaning they will likely find people when they are most infectious, said Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health and an advocate of low-cost, widely available at-home testing that can be done on a paper strip.

. . .

The FDA also has said that rapid tests should have comparable accuracy to PCR diagnostic tests—a requirement that some public health specialists and companies say is overly stringent for surveillance testing.

An FDA official noted sensitivity rates lower than PCR might be acceptable, depending on how the test results are used. The agency has allowed for antigen tests with a sensitivity rate of 80% or better, the official said. “You can even have lower than 80% sensitivity” if it is a recurring or serial test.

For the full story, see:

Brianna Abbott, and Thomas M. Burton. “Speed Over Precision Favored in Covid Tests.” The Wall Street Journal (Wednesday, September 9, 2020): A1 & A6.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story has the date Sep. 8, 2020, and has the title “Public Health Officials Pursue Covid-19 Tests That Trade Precision for Speed.” Where there are differences between the print and online versions, the passages above follow the online version.)

The report by The Rockefeller Foundation mentioned above is:

The Rockefeller Foundation. “National Covid-19 Testing & Tracing Action Plan.” Thurs., July 16, 2020.

Randomized Controlled Trials Can Obscure “Nuances and Complexities”

(p. A17) You’ve probably heard of the “gold standard”—randomized controlled trials—for evaluating new pharmaceutical therapies, including for Covid-19. Many treatments that showed promise in other studies have turned up muddy results in randomized controlled trials. But that doesn’t mean they’re necessarily ineffective. Doctors and regulators need to consider the totality of medical evidence when treating patients.

. . .

“Randomized trials for some purposes is the gold standard, but only for some purposes,” Harvard’s Donald Berwick, a former health adviser to President Barack Obama, said in an interview with GNS Health Care CEO Colin Hill in 2013. “Context does matter. We’re learning in a very messy world, and the context that neatens up that world may make it hard to know how to manage in the real world.”

. . .

As Thomas Frieden, who directed the Centers for Disease Control and Prevention under Mr. Obama, wrote in a 2017 New England Journal of Medicine article: “Elevating RCTs at the expense of other potentially highly valuable sources of data is counterproductive.” Such limitations affect their use for “urgent health issues, such as infectious disease outbreaks.” He added: “No study design is flawless, and conflicting findings can emerge from all types of studies.”

. . .

Some experts have dismissed the antimalarial hydroxychloroquine, or HCQ, even though more than a dozen observational studies have found it beneficial. A retrospective observational study of Covid-infected nursing-home residents in France, for instance, found those treated with HCQ and azithromycin were 40% less likely to die.

But a few randomized controlled trials found no benefit. A Spanish randomized trial of HCQ for prophylaxis found it didn’t reduce risk of illness among a large group of people exposed in nursing homes, households and health-care settings. Yet two-thirds of the subjects “reported routine use of masks at the time of exposure,” so they were probably less likely to be infected. Nursing-home residents, who may be less likely to wear masks, were 50% less likely to become sick if they took HCQ. But this finding was statistically insignificant, because the trial included only 293 residents.

. . .

Another problem with Covid-19 randomized trials: Patients at different stages of an illness are often assigned the same dosage. Trials don’t reveal differences in how patients respond to a drug at different dosages or illness severity.

Observational studies can do so. Consider a large study by the Mayo Clinic, which found no overall benefit among patients who received a higher-antibody convalescent plasma versus a lower one. Yet the researchers reported a 37% reduction in mortality among patients under 80 who weren’t on a ventilator and received a high-antibody plasma within three days of hospitalizations.

A randomized trial might have obscured these nuances and complexities, denying doctors important information about treatment options. Randomized controlled trials can yield important insights, but it is a medical mistake and a disservice to patients to dismiss other types of evidence.

For the full commentary, see:

Allysia Finley. “Medical Research’s Cross of ‘Gold’ Imperils Covid Treatments.” The Wall Street Journal (Wednesday, September 9, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 8, 2020, and has the same title as the print version.)

The review article by Frieden mentioned above is:

Frieden, Thomas R. “Evidence for Health Decision Making — Beyond Randomized, Controlled Trials.” New England Journal of Medicine 377, no. 5 (Aug. 3, 2017): 465-75.

Masks Blocked Covid-19 at Hair Salon

(p. A6) Vigilant mask wearing might have spared nearly 140 people from catching the coronavirus at a hair salon in Missouri, according to a report published on Tuesday [July 14, 2020] by the Centers for Disease Control and Prevention. In May [2020], the people interacted with two hair stylists with confirmed coronavirus infections, but none ended up showing symptoms of Covid-19.

. . .

But policies instructing locals to cover their mouths and noses, put in place by the city of Springfield and by the salon where the stylists worked, Great Clips, appear to have played a substantial role in curbing the spread of disease.

For the full story, see:

Katherine J. Wu. “Report on Hair Salon Affirms Value of Masks.” The New York Times (Thursday, July 16, 2020): A6.

(Note: ellipsis, and bracketed dates, added.)

(Note: the online version of the story was updated July 17 [sic], 2020, and has the title “2 Stylists Had Coronavirus, but Wore Masks. 139 Clients Didn’t Fall Sick.”)

The CDC report mentioned above is:

Hendrix MJ, Walde C, Findley K, Trotman R. Absence of Apparent Transmission of SARS-CoV-2 from Two Stylists After Exposure at a Hair Salon with a Universal Face Covering Policy — Springfield, Missouri, May 2020. MMWR Morb Mortal Wkly Rep 2020;69:930-932.

Our Government Sends 19-Year-Olds to War but Does Not Allow Them to Try High-Risk, High-Reward Covid-19 Drugs and Vaccines

(p. A11) “Many drug programs are suspended or not pursued at all—not because of flaws in the science but because of commercial and strategic reasons,” Mr. Milken says. Researchers screen those programs, and he calls in his partners either to fund the ideas or promote their development at other companies if the inventors make them available.

It’s a niche in the pharmaceutical world that public funding can’t fill. Mr. Milken sustains a model “where a person could just give me a five-page summary and get a meeting. Government isn’t going to fund that, but philanthropy does.” “These little companies,” he adds—“they’re not Johnson & Johnson, they’re not Novartis, they’re not Amgen. They need financial capital.”

. . .

Mr. Milken’s deals not tinged by controversy, such as his 1983 issuance of bonds to finance telecom company MCI’s long-distance network, show the same preference that shapes his philanthropy: high risk for a high reward.

. . .

A perennial struggle for Mr. Milken has been to convince regulators to share that urgency. He says drug trials generally are too rigid: “We send 19-year-olds into war zones knowing that no matter what we do, some number—greater than zero—will lose their lives or their limbs. But we tell a patient who is going to die not to try something because it could be dangerous.”

Nonetheless, the partners he’s made in his search for cures prove that imagination and activity are still scattered through the country. Discussing the coronavirus with biotech founders and Nobel Prize winners, Mr. Milken says he’s been “thrust back into the 1970s and early ’80s, where any time someone had a new idea—a new company, a passion for something—I had set aside time every day to listen.” On the day a vaccine or effective cure for Covid-19 is finally announced, Americans will owe thanks to such risk takers, who Mr. Milken says “invest in where the world is going, not where it is.”

For the full interview, see:

Mene Ukueberuwa, interviewer. “THE WEEKEND INTERVIEW; What Would You Risk for a Faster Cure?” The Wall Street Journal (Saturday, May 2, 2020): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date May 1, 2020, and has the same title as the print version.)

Former FDA Research Virologist Suggests “Accelerated Approvals” of Covid-19 Vaccines

(p. A15) Covid-19 is a genuine emergency. Drug and biotech companies and academic institutions are doing their part, and regulators need to, as well. Having been a research virologist who spent 15 years at the FDA as the agency’s “biotechnology czar,” I have some suggestions:

. . .

• The FDA should issue “accelerated approvals” after testing in only limited populations. Additional subgroups—children, pregnant women, etc.—can be tested after approval. The accelerated approvals should be granted before the duration of postvaccination immunity has been ascertained. More-comprehensive trials can then confirm safety, efficacy and the length of time that immunity lasts.

• Establish reciprocity of approvals between the FDA and trusted counterparts in certain foreign countries (Australia, Canada, New Zealand, Japan, the Scandinavian countries and the European Medicines Agency), so that if one of them approves a vaccine, it is automatically approved in the other countries.

For the full commentary, see:

Henry I. Miller. “A Covid Vaccine: Faster, Please.” The Wall Street Journal (Thursday, April 23, 2020): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date April 22, 2020, and has the title “A Coronavirus Vaccine: Faster, Please.”)

Patients Die Due to Doctors Who Are “Busy Entering Health Care Data” Required by “Mandated Protocols”

(p. 18) Doctors today often complain of working in an occupational black hole in which patient encounters are compressed into smaller and smaller space and time. You can do a passable job in a 10-minute visit, they say, but it is impossible to appreciate the subtleties of patient care when you are rushing.

Enter “Slow Medicine: The Way to Healing,” a wonderful new memoir by Dr. Victoria Sweet.

. . .

One of the most compelling stories in the book is about Joey, a 3-year-old who is diagnosed with terminal lung disease after a near-drowning but against the odds makes it off the ventilator and out of the hospital. Sweet interprets Joey’s recovery in part as a victory for prayer. “Prayer worked,” she writes, “at least that once and maybe sometimes and maybe always.” I would see it differently: Joey was saved because a lung specialist slowly decreased airway pressure and tidal volume over several weeks in a patient with acute respiratory distress syndrome. And, as Sweet points out, it was slow medicine that allowed that doctor to make the proper adjustments.

Perhaps Sweet’s most depressing conclusion is that Joey would have died today. His doctors “would have been too busy entering health care data” that was required “according to all the mandated protocols.”

For the full review, see:

Sandeep Jauhar. “Heals Over Time.” The New York Times Book Review (Sunday, January 28, 2018): 18.

(Note: ellipsis added.)

(Note: the online version of the review has the date Jan. 26, 2018, and has the title “A Doctor Argues That Her Profession Needs to Slow Down, Stat.”)

The book under review is:

Sweet, Victoria. Slow Medicine: The Way to Healing. New York: Riverhead Books, 2017.

“Fat Cats” Fund Cancer Detection “Holy Grail”

(p. A15) So often the future shows up when you’re looking for something else. In 2013, DNA sequencing company Illumina bought Verinata Health and began offering noninvasive prenatal testing. Using a pregnant woman’s blood, a now-$500 DNA test can spot Down syndrome and other chromosomal conditions. Since then, the use of very invasive needle-to-the-womb amniocentesis testing has dropped.

But that’s not the story here. Of the first 100,000 women tested, 10 (or 0.01%) had unusual chromosome patterns. The fetus was fine, but in each case, the mother had cancer of differing types.

. . .

So Illumina spun out a new company named Grail in Menlo Park, Calif., to do what’s known as Circulating Cell-free Genome Atlas studies. Running DNA sequencing on regular blood samples, Grail generates hundreds of gigabytes of data per person—the well-known A-T-G-C nucleotides, but also the “methylation status,” or whether a particular DNA site’s function is turned on or off (technically, whether or not it represses gene transcription).

. . .

. . . , Grail’s chief medical officer Josh Ofman tells me, “cancer may show up as thousands of methylation changes, a much richer signal to teach machine learning algorithms to find cancer” vs. a single site. “There are 30 million methylation sites in the entire human genome on 100,000 DNA fragments. Grail looks at a million of them.” It takes industrial-grade artificial intelligence to find patterns in all this data, something a human eye would never see.

. . .

Grail is detecting the signature of actual cancer cells in your blood. According to validation data published in the Annals of Oncology, the test can find 50 different types, more than half of all known cancers.

. . .

Grail has raised almost $2 billion, including from Bill Gates and Jeff Bezos. Isn’t that interesting? Though much maligned as fat cats sitting on piles of gold coins and monopolists out to control the world, Messrs. Gates and Bezos are investing in technology—this is not philanthropy—that may save you or a relative’s life someday.

Innovation comes through surprises. This is a big one. And while worrywarts brood over artificial intelligence and robot overlords, early detection of cancer is really what machine learning is meant for. This is the Holy Grail.

For the full commentary, see:

Andy Kessler. “INSIDE VIEW; Cancer Screening Leaps Forward.” The Wall Street Journal (Monday, July 6, 2020): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date July 5, 2020, and has the same title as the print version.)