Category: Regulations

“Real World Evidence” on Effectiveness of Experimental Drugs Can Be Extracted From Electronic Health Records

(p. A7) . . . analysis of compassionate-use data, about the experimental drug remdesivir from Gilead Sciences Inc. published in the New England Journal of Medicine, came under criticism. Scientists pointed out that the Covid-19 patients received the drug in centers around the world where care may have differed, data on some patients was incomplete and there was no comparison group.

That study’s first author, Jonathan Grein, of Cedars-Sinai Medical Center in Los Angeles, said given how little is known about the coronavirus and how to treat it, “I think at this point any information is potentially helpful.” He said the study, funded by Gilead Sciences, noted the findings were limited and preliminary. “It is a starting point, an opportunity to aggregate our initial experiences,” he said.

. . .

The FDA . . . has worked closely with companies trying to extract “real world evidence” about patients’ experiences with new or experimental drugs from sources such as electronic health records.

For the full story, see:

Amy Dockser Marcus. “Hundreds Get Plasma in National Study.” The Wall Street Journal (Wednesday, April 22, 2020): A7.

(Note: ellipses added.)

(Note: the online version of the story has the date April 21, 2020, and has the title “Hundreds Receive Plasma From Recovered Coronavirus Patients in National Study.”)

EPA Brags of Taking Weeks to Approve Soft-Pack Packaging for Scarce Disinfectant Wipes

New York (CNN)The coronavirus pandemic has made all kinds of virus-busting home cleaning products nearly impossible to find.

Disinfectant wipes, especially, are in high demand with consumers clearing out shelves just as quickly as stores restock them.

But now, one of the biggest makers of private-label wipes says tens of millions more wipes are expected to hit store shelves.

Rockline Industries, which makes Good & Clean wipes and store brand products for major retailers, said the wipes will be available at stores later this month.

. . .

Rockline was able to increase its wipes production because of a packaging tweak.

Cleaning wipes are predominantly packaged in hard plastic canisters, unlike baby wipes, which usually come in soft-packs.

. . .

But the unprecedented demand for household disinfectant wipes led to Rockline maxing out its canister production. It needed a different solution to be able to quickly and significantly increase the volume of packaged wipes to meet demand.

. . .

Given how quickly the disinfectant wipes supply is depleting in the market in response to the pandemic, Rockline, in February [2020], started exploring different ways to expedite supply, including alternative packaging formats.

The disinfectant wipes products are registered with the Environmental Protection Agency, which oversees the category and approves new products, new ingredients and packaging changes for individual companies.

So, several weeks ago, Rockline had talks with the EPA about putting its disinfectant wipes in soft-packs in addition to canisters as a way to get even more product into stores. Clorox and Lysol already sell some wipes in soft-packs.

“Typically the approval could take several months,” Dresselhuys said. Rockline was able to get the approval in just a matter of weeks.

The EPA said it’s in its interest to ensure Americans have access to approved surface disinfectant products effective against the novel coronavirus.

“To this end, the agency is expediting disinfectant product reviews and identifying regulatory flexibilities to avoid supply chain disruptions, including ingredient sourcing changes, manufacturing location additions or changes, and packaging changes,” the agency said in a statement to CNN Business.

For the full story, see:

Kavilanz, Parija. “No One Can Get Disinfectant Wipes. One Company Found a Clever Solution to Put Them on Shelves.” In CNN Business, Fri., May 1, 2020, URL: https://www.cnn.com/2020/05/01/business/disinfectant-wipes-shortage-coronavirus/index.html.

(Note: ellipses added.)

“Masks Are Pilloried Until They Are Mandatory”

(p. 6) The surreal reality of American cities and towns also mirrors the half-remembered, half-empty approximations explored in sleep, ordered by the same pliable, foggy logic: Masks are pilloried until they are mandatory; liquor stores open early for sexagenarians only; an invisible plague makes people fall gravely ill seemingly at random; touching anything — everything — is banned.

For the full story, see:

Caity Weaver. “The Interpretation of Viral Dreams.” The New York Times, SundayStyles Section (Sunday, April 12, 2020): 6.

(Note: the online version of the story has the date April 11, 2020, and has the title “Why Am I Having Weird Dreams Lately?”)

Covid-19 Pandemic Reduces Appeal of Reusable Bags

(p. B5) An oft-cited study by researchers at the University of Arizona and Loma Linda University found that reusable plastic bags can contain bacteria, and that users don’t wash reusable bags very often.

. . .

In New York, John Flanagan, the top Republican in the State Senate, called for the state this month to suspend the plastic bag ban that went into force on March 1 [2020]. The ban’s enforcement had already been delayed pending a legal challenge unrelated to the virus.

“Now is not the time or place,” Mr. Flanagan said in an interview. “This is a state of emergency.” Moreover, “people miss the plastic bags,” he said. “They were very functional and useful. We need to reopen the discussions.”

Libertarian groups have joined the effort. In Albuquerque, the Rio Grande Foundation, which bills itself as New Mexico’s premier free-market think tank, has spearheaded opposition to a move to strengthen the city’s plastic bag ban.

. . .

“Is there a worse idea in this time of Coronavirus,” the group quipped in a recent posting on Twitter, “than a plan to ‘more fully’ ban plastic bags?’”

Some supermarket chains have moved ahead with their own ban on reusable bags. The Midwestern supermarket chain Hy-Vee has said it was no longer accepting reusable bags at their stores. Price Chopper said on Twitter that it was phasing plastic bags back into use at its stores in New York.

For the full story, see:

Hiroko Tabuchi. “Plastics Industry Sees Chance to Undo Bans on Single-Use Bags.” The New York Times (Friday, March 27, 2020): B5.

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

(Note: the online version of the story has the date March 26, 2020, and has the title “In Coronavirus, Industry Sees Chance to Undo Plastic Bag Bans.”)

The “oft-cited study” mentioned above, is:

Williams, David L., Charles P. Gerba, Sherri Maxwell, and Ryan G. Sinclair. “Assessment of the Potential for Cross-Contamination of Food Products by Reusable Shopping Bags.” Food Protection Trends 31, no. 8 (Aug. 2011): 508–13.

“Two Promising Approaches” for Drugs to Reduce Severe Cases of Covid-19

(p. A19) Americans would have the confidence to return to work, even if the virus is still circulating in the fall, if they knew that a robust screening system is in place to identify and arrest new outbreaks and medication can significantly reduce the chance of becoming severely ill. Kevin Warsh, a former Federal Reserve governor, estimates that such a drug could restore at least $1 trillion in economic activity.

. . .  There are two promising approaches, and both could be available soon if government and private industry do things right.  . . .

One approach involves antiviral drugs that target the virus and block its replication. Think of medicines for treating influenza, HIV or cold sores. The drugs work by blocking the mechanisms that viruses use to replicate.  . . .

The other approach involves antibody drugs, which mimic the function of immune cells. Antibody drugs can be used to fight an infection and to reduce the risk of contracting Covid-19. These medicines may be the best chance for a meaningful near-term success.

Antibody drugs are based on the same scientific principles that make “convalescent plasma” one interim tactic for treating the sickest Covid-19 patients. Doctors are taking blood plasma from patients who have recovered from Covid-19 and infusing it into those who are critically ill. The plasma is laden with antibodies, and the approach shows some promise. The constraint: There isn’t enough plasma from recovered patients to go around.

For the full commentary, see:

Scott Gottlieb. “Bet Big on Treatments for Coronavirus; Antivirals and antibody therapies are showing promise. The FDA needs to step up its pace.” The Wall Street Journal (Monday, April 6, 2020): A19.

(Note: ellipses added.)

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

Scientists Are “a Political Interest Group Like Any Other”

(p. B15) Mr. Greenberg, who spent most of his professional life in Washington, became a science journalist at a time when many practitioners seemed to view their job as advancing the cause of research — a consideration that many researchers expected.

As an author, newspaper reporter and magazine editor, and as the founding editor and publisher of Science & Government Report, a newsletter he ran for almost 30 years, Mr. Greenberg took a different view.

From his vantage point in the capital, he tracked scientific rivalries and battles over the government’s science priorities, describing research not as a uniquely worthy activity but rather as one of many enterprises competing for federal largess.

“He recognized that science, and the scientific endeavor broadly, was a political interest group like any other, and they behaved like any other, and he covered them like any other,” said Daniel Sarewitz, a congressional staffer in the science policy arena in the early 1990s and now director of the Washington-based Consortium for Science, Policy and Outcomes at Arizona State University.

“He was not a toady or an advocate for the science community,” Dr. Sarewitz said. “He was a journalist covering science.”

Writing in The New York Times Book Review in 1968, Robert K. Merton, the eminent 20th-century sociologist of science, said Mr. Greenberg’s “perceptive” first book, “The Politics of Pure Science,” was one that “should be read by the President, legislators, scientists and the rest of us ordinary folk.”

For the full obituary, see:

Cornelia Dean. “Daniel S. Greenberg, 88, Science Journalist.” The New York Times (Thursday, March 26, 2020): B15.

(Note: the online version of the obituary was last updated March 26, 2020, and has the title “Daniel S. Greenberg, Science Journalist and Iconoclast, Dies at 88.” Williams’s question is in bold; Achorn’s answer is not in bold.)

The second edition of the book by Greenberg, mentioned in the passage quoted above, is:

Greenberg, Daniel S. The Politics of Pure Science. Second ed. Chicago: University of Chicago Press, 1999.

French Jobs Rise as Labor Regulations Fall

(p. A1) PARIS — One after another, the speakers in Parliament have denounced President Emmanuel Macron and his revolutionary plans, calling them “cynicism” and a “flagrant crime.” Outside, hundreds of protesters shout their fury. Other demonstrators, invoking a long French tradition, have called for his head.

. . .

(p. A6) Mr. Macron has upset the French, and he is deeply unpopular for it. So it has become the defining paradox of his rule that he remains much despised, even as his changes begin to bear fruit.

The intractable unemployment rate, slayer of his predecessors, appears finally to be bending to a French president’s touch, recently reaching its lowest rate in 12 years at 8.1 percent.

Working-age employment rates are up, worker-training programs are showing big gains, quality long-term job contracts are outpacing precarious, short-term ones.

All of those are advances plausibly attributed to Mr. Macron’s landmark loosening of the rigid French labor market.

For the full story, see:

Adam Nossiter. “As the French Call for His Head, Macron Is Reshaping the Nation.” The New York Times (Wednesday, February 26, 2020): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the story has the date Feb. 25, 2020, and has the same title “As Emmanuel Macron’s Impact Grows, So Does French Disdain.”)

A Dynamic Industry, Like Wireless, Counsels “Greater Caution in Judicial Intervention”

(p. A13) Donald Trump’s administration likes living dangerously on 5G. It pulled an unlikely victory out of its hat when a judge approved the wireless merger of Sprint and T-Mobile that’s been in the works for nearly a decade. The judge gave the OK, he said, because his crystal ball (his words) was just as good or bad as those of the plaintiffs and defendants.

His most sensible and telling observation came on page 148, where he suggested that a dynamic and rapidly changing industry like wireless counseled “greater caution in judicial intervention.”

For the full commentary, see:

Holman W. Jenkins, Jr. “Trump Outswamps the 5G Swamp.” The Wall Street Journal (Wednesday, February 19, 2020): A13.

(Note: the online version of the commentary has the date Feb. 18, 2020, and has the title “YOUR HEALTH; Here’s Why Health Experts Want to Stop Daylight-Saving Time.” Where there is a difference in wording in the first quoted paragraph, the online version is used.)

Daylight-Saving Time Is Bad for Brain and for Health

(p. A12) Beth Ann Malow, a professor of neurology at Vanderbilt University Medical Center in Nashville, Tenn., wrote in an opinion piece in JAMA Neurology that switching between daylight-saving time and standard time is bad for the brain. “Going back and forth is ridiculous and disruptive, it makes no sense,” said Dr. Malow, who believes permanent standard time would be healthier for all.

. . .

Muhammad Adeel Rishi, a pulmonologist and sleep physician at the Mayo Clinic Health System in Wisconsin, is the lead author of a daylight-saving time position statement that the American Academy of Sleep Medicine intends to publish this year.

About half-a-dozen studies have found a 5% to 15% increased risk of having a heart attack during the days after shifting to daylight-saving time. “It’s a preventable cause of cardiac injury,” Dr. Rishi said. One study found the opposite effect during the fall, in the days after the transition back to standard time. “So maybe the risk stays high throughout the time when we are on daylight-saving time,” he said.

For the full commentary, see:

Sumathi Reddy. “YOUR HEALTH; Why Daylight-Saving Time Is Bad for You.” The Wall Street Journal (Thursday, March 5, 2020): A12.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date March 4, 2020, and has the title “YOUR HEALTH; Here’s Why Health Experts Want to Stop Daylight-Saving Time.” Where there is a difference in wording in the first quoted paragraph, the online version is used.)

The opinion piece co-authored by Beth Ann Malow, and mentioned above, is:

Malow, Beth A., Olivia J. Veatch, and Kanika Bagai. “Are Daylight Saving Time Changes Bad for the Brain?” JAMA Neurology 77, no. 1 (2020): 9-10.