Category: Regulations

China’s “Emergency-Use” Rule Allows Vaccinating Hundreds of Thousands Against Covid-19

(p. A1) A Chinese pharmaceutical company has injected hundreds of thousands of people with experimental Covid-19 vaccines, as its Western counterparts warn against administering mass vaccinations before rigorous scientific studies are complete.

China National Biotec Group Co., a subsidiary of state-owned Sinopharm, has given two experimental vaccine candidates to hundreds of thousands of people under an emergency-use condition approved by Beijing in July [2020], the company said this week.

For the full story, see:

Chao Deng. “China Tests Vaccines on Hundreds of Thousands.” The Wall Street Journal (Saturday, September 12, 2020): A1 & A8.

(Note: bracketed year added.)

(Note: the online version of the story was updated September 12, 2020, and has the title “China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines.”)

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

Plastic Bag Bans Are Reversed Because Covid-19 Clings to Reusable Bags

(p. 8A) PORTLAND, Ore. (AP) — Just weeks ago, cities and even states across the U.S. were busy banning straws, limiting takeout containers and mandating that shoppers bring reusable bags or pay a small fee as the movement to eliminate single-use plastics took hold in mainstream America.

What a difference a pandemic makes.

In a matter of weeks, hard-won bans to reduce the use of plastics — and particularly plastic shopping sacks — across the U.S. have come under fire amid worries about the virus clinging to reusable bags, cups and straws.

Governors in Massachusetts and Illinois have banned or strongly discouraged the use of reusable grocery bags. Oregon suspended its brand-new ban on plastic bags this week, and cities from Bellingham, Washington, to Albuquerque, New Mexico, have announced a hiatus on plastic bag bans as the coronavirus rages.

For the full story, see:

AP. “Virus Deals a Blow to Bans on Plastic Bags.” Omaha World-Herald (Monday, April 20, 2020): 8A.

More Work-Life Balance for Some Workers Means Less Work-Life Balance for Other Workers

(p. 3) I work for a successful, fast-growing technology company. There are times when some corporate “crisis” requires that a number of us lean in more in terms of office hours. My married, straight co-workers with children can easily bow out — while as a gay, single and child-free person, I get left with extra work because I am seen as not having responsibilities at home. I’m not unsympathetic to the difficulties my co-workers have in balancing work and life, but why does it have to be balanced on my back?

— Anonymous

. . .

You have every right to push back when you are imposed upon like this. Either everyone is responsible for extra work, or no one is. Your co-workers do not get to categorically decide that you have the time to handle the company’s crises because your life is arranged differently than theirs.

For the full story, see:

Roxane Gay. “A Great Work-Life Balance, Thanks to Me.” The New York Times, SundayBusiness Section (Sunday, August 23, 2020): 3.

(Note: ellipsis added.)

(Note: the online version of the story has the date Aug. 21, 2020, and has the title “My Colleagues Have Great Work-Life Balance (Thanks to Childless Me).”)

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.

Blacks Most Hurt by Creeping Credentialism

(p. A15) Nonessential degree requirements aren’t race-neutral. They embed into the labor market the legacy of black exclusion from the U.S. education system—namely, the antiliteracy laws that made it illegal for blacks to learn to read, the separate and unequal schools that kept them from catching up, and the limited progress since then on policies designed to remedy racial discrimination.

This spring, we and six other colleagues wrote a National Bureau of Economic Research working paper that questioned the fundamental assumption undergirding the proliferation of degree requirements: that workers without four-year degrees who earn low wages are low-skilled.

For the 71 million U.S. workers who have a high-school diploma but not a four-year degree, we used the skill profile of their current jobs as a proxy for their employability for higher-wage work. Their job experience suggests they are skilled through alternative routes, so we call them by the acronym STARs. They make up 60% of the active U.S. workforce.

Our research found that 16 million STARs have the skills for high-wage work, defined as earning more than twice the national median. Yet 11 million of them are currently employed in low-wage or middle-wage work. This suggests an extraordinary market failure: U.S. companies are systematically overlooking talent.

. . .

Our research suggests there are changes companies can make to address this problem:

• Hire for skills and work experience, not degrees. Rather than using the degree requirement as a default, employers should examine the skills that their jobs require and then use skill requirements for job postings, screenings and assessments. IBM adopted this type of skills-based approach with its New Collar initiative, launched in 2017.

. . .

Black workers face extraordinary barriers to economic mobility. By valuing skills over degrees, companies can improve the way the labor market functions for black STARs—a necessary step to ensure that the economy works for all.

For the full commentary, see:

Peter Q. Blair and Shad Ahmed. “The Disparate Racial Impact of Requiring a College Degree.” The Wall Street Journal (Monday, June 29, 2020): A15.

(Note: ellipses added; bullet point and italics in original.)

(Note: the online version of the commentary has the date June 28, 2020, and has the title “A Coronavirus Vaccine: Faster, Please.”)

The NBER working paper mentioned above is:

Blair, Peter Q., Tomas G. Castagnino, Erica L. Groshen, Papia Debroy, Byron Auguste, Shad Ahmed, Fernando Garcia Diaz, and Cristian Bonavida. “Searching for Stars: Work Experience as a Job Market Signal for Workers without Bachelor’s Degrees.” In NBER Working Papers: National Bureau of Economic Research, Inc., March 2020.

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.