re-post of Politico article about the FDA’s “nerdy virologists” panel working on Covid-19 vaccine approval

VACCINE RACE

The ‘nerdy virologists’ steering the U.S. vaccine race

The political backdrop could make the first coronavirus gathering of the advisory committee one of the most-watched in FDA history.

A single-dose Covid-19 vaccine being developed by Johnson & Johnson. | Cheryl Gerber/Courtesy of Johnson & Johnson via AP

A single-dose Covid-19 vaccine being developed by Johnson & Johnson. | Cheryl Gerber/Courtesy of Johnson & Johnson via AP

By SARAH OWERMOHLE

10/16/2020 04:30 AM EDT

As the race for the first coronavirus vaccines rounds the final turn, an obscure but influential panel of Food and Drug Administration advisers is emerging as a crucial referee.

The group of academic scientists, doctors and federal healthofficials will scrutinize safety and efficacy data on every coronavirus vaccine candidate, and make a pivotal recommendation to the FDA on whether to greenlight or shelve each shot.

Although its decisions aren’t binding, the panel has taken on an outsized importance leading up to its first coronavirus meeting on Oct. 22. President Donald Trump has repeatedly said that a shot could come before Election Day — and has accused the FDA of standing in the way of progress. Meanwhile, the agency is trying to hold the line on new, stricter standards for authorizing the emergency use of any vaccine,and safety concerns have paused late-stage trials of two of the four frontrunner vaccine candidates.

The political backdrop, and plummeting public confidence in the race for a vaccine, could make the first coronavirus gathering of the Vaccines and Related Biological Products Advisory Committee one of the most-watched in FDA history. Topics the group expects to cover include some of the thorniest and most fundamental questions in vaccine development, such as when a vaccine can truly be declared safe and where to set the bar for efficacy during a deadly global pandemic.

“It’s a group of nerdy virologists sitting around,” said Paul Offit, a University of Pennsylvania vaccine expert who sits on the panel and co-developed the rotavirus shot. “You don’t see many situation comedies about a group of fun-loving virologists and epidemiologists. For a reason.”

Nevertheless, the FDA is preparing for tens of thousands of people to tune into the panel’s initial meeting — a departure from past practice for similar advisory committees attended largely in person by DC-area experts and academics. Such meetings normally attract an online audience of just 100 to 1,500 people, an FDA spokesperson said.

No single vaccine is expected to be ready for review by Oct. 22. But the advisory group is on standby to discuss the merits of each shot as drugmakers file applications for FDA authorization or approval — making the panel a prominent player in the final crucial months of the United States’ vaccine push.

“We don’t work for the government nor do we work for the industry. We’re just supposed to come there and look at data,” said Offit.

The 20-member committee is a mix of physicians, statisticians, vaccine and infectious disease experts along with two drug company representatives and a consumer representative, in this case a lawyer. A five-person cluster hails from FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, but the rest work outside the government.

The vaccine group is one of dozen expert panels convened by the FDA to review data or discuss a hot-button issue in a specific field — others are for food, tobacco and drugs, for instance — and advise the agency on what they should do.

Although the FDA does not have to follow its advisory committees’ advice, it generally does. Commissioner Stephen Hahn and other agency officials including vaccine chief Peter Marks have repeatedly pointed to the Oct. 22 vaccine meeting as evidence that the agency is led by science and data, not politics.

“It’s critical for FDA to make the public aware of our expectations of the data requirements to support safety and effectiveness,” Hahn tweeted Thursday with a link to the upcoming meeting, adding that a discussion between outside scientific and public health experts will help the public understand the vaccine review process.

The biggest issue on the table — and the subject of recent disputes between FDA and the White House — is when a vaccine maker can declare their shot safe and effective. Committee members also told POLITICO that they expect to discuss diversity in volunteer enrollment and the impact that emergency authorization could have on ongoing trials for other shots.

“We want to assure the American people that the process and review for Covid-19 vaccine development will be as open and transparent as possible,” Marks, director of the Center for Biologics Evaluation and Research, said in a statement to POLITICO.

While a specific vaccine is not on the table for Oct. 22, the discussion about enrollment, safety follow-up and the bar for efficacy could have implications for all the manufacturers in late-stage trials.

Pfizer, considered a frontrunner as it works through Phase III trials, told POLITICO last week that it does not plan to submit data ahead of the meeting. AstraZeneca and Johnson & Johnson, two other manufacturers in the sweeping final stages of trials, have each paused those studies because of serious side effects in a patient. AstraZeneca, which announced the halt in September, still has not restarted its U.S. trials.

Manufacturers have refused to promise to file within a specific timeframe, noting that their speed will be dictated by the data they collect — and unanticipated factors, like pausing a study for safety reasons, could slow them down.

FDA also bolstered its expectations for vaccine makers earlier this month, saying each needs to follow at least half of the participants in their Phase III trials for two months before applying for an emergency-use authorization. The new standards all but shut the window to any company filing before Election Day, prompting the president to accuse career scientists of holding back progress for political reasons.

“We don’t live in a bubble. We hear and see what is happening around the world and the concern that many people in the public have expressed of, in their words, the vaccine is being rushed [and] corners being cut,” said Archana Chatterjee, dean of Rosalind Franklin University’s Chicago Medical School and member of the committee.

The intense public scrutiny and vast demand for a coronavirus vaccine, along with the record speed at which shots have been developed — many using untested technologies — make the FDA panel’s October meeting unlike any before, said Chatterjee.

“Part of our job is to make sure that we can act as we always do,” she said. “To the best of our ability, reassure the public that we are doing our job free from any kind of interference from anyone with regard to the safety and effectiveness of those vaccines.”

By function, FDA advisory committees meet on testy topics. Recent hot-button issues before other panels include e-cigarettes, cancer-linked breast implants and how to fix opioid approvals amid an addiction crisis. But nothing has captured the president’s attention more than finding a vaccine to help end the pandemic that has killed nearly 220,000 people in the U.S. and ground the economy to a halt.

“I think this upcoming meeting will be important to establish the ground rules for evaluating vaccine safety and efficacy, in anticipation of [emergency use authorization] applications that could come from multiple manufacturers in the coming year,”said Paul Spearman, a professor and director for infectious diseases at the Cincinnati Children’s Hospital. He usually sits on the FDA vaccine-advisory committee but will not participate on Oct. 22 because he is involved in Covid-19 vaccine trials.

Panel chair Hana El Sahly, a virologist and microbiologist at Baylor University, and Fred Hutchinson Cancer Research Center biostatistician Holly Janes, are also recused from the Oct. 22 panel because of potential conflicts. They and Spearman may be recused from future meetings on specific vaccines depending on their research, leading FDA to draw other experts temporarily into the committee.

An FDA spokesperson said the full committee roster, including possible temporary replacements, will be published 48 hours before the Oct. 22 meeting.

Emergency use authorizations, a bar lower than full FDAapproval, have become a contentious issue in the Trump administration. The White House pushed the FDA to authorize the malaria drug hydroxychloroquine for the coronavirus, a charge that FDA denies. The agency ultimately revoked the authorization after studies showed no positive effect from the pills. Other emergency authorizations, such as one forconvalescent plasma, have been roiled in bumpy rollouts that were also colored by the president’s calls for FDA to speed its review.

HHS has pushed the FDA to re-brand the authorization of any coronavirus vaccine as a “pre-licensure” to bolster public confidence — something the drug agency has so far resisted over fears of politicizing its scientific determinations, POLITICO revealed this week.

The advisory committee is likely to discuss how awarding one vaccine an emergency authorization could make it harder for other companies to find participants for clinical trials of their own shots, Spearman said, since those shots would be unproven and some volunteers would receive a placebo.

Another hot topic is whether trials have enrolled sufficiently diverse groups of participants. The coronavirus has disproportionately infected, hospitalized and killed Black and Latinx populations, but the two groups have historically been under-represented in trials. Lawmakers such as Sen. Maggie Hassan (D-N.H.) have also raised concerns that trials aren’t including enough elderly people to determine whether shots are safe and effective in the elderly, since the immune system weakens with age.

Broadly, committee members told POLITICO they are sharply aware of balancing the need for vaccines against the potential disaster of greenlighting something dangerous or ineffective because regulators moved too soon.

“We are in very extraordinary times,” said Chatterjee. “Ordinarily I take this role seriously anyhow, but I think under these circumstances I’ve been thinking about it in a slightly different way.” POLITICO

A Word About Words From the OED

The Oxford English Dictionary remains THE word bible of the English language.   The OED is available online, with a Word-of-the-Day feature to which one can subscribe without cost.   A full subscription is beyond my budget, and I do respect the OED’s the prohibition against re-posting in its entirety.   Anyone can subscribe to the daily word post  through the OED web site at http://www.oed.com/ to receive the without-cost daily.

Often these selected words grab my attention for various reasons, not only to find out what they mean, but also as discussion topics.

A recent word that intrigued me especially is  —  dis-candy — which means literally liquifying or melting candy (lemon drops, or life savers for example,) from its candied/solid state to the sticky gooey mess that sticks to everything when melted.

Shakespeare used the word to good advantage, with a metaphorical meaning, as taking the overly-sweet or romantic useage of cleaning up “purple prose” or misplaced or just overstated descriptions in a line of poetry or speech.    English teachers often like to “dis-candy” students’ writing.

My wonder isn’t really the word itself, but the prefix (DIS -candy. )    Some substance that starts out as a sticky-sweet solid that  deteriorates into a liquid, or disappears; or a cringe-worthy saccharine sweetness in speech or prose.     Upon consideration I suppose that (DE-candy) would have a different connotation, perhaps meaning some of the  ingredients or adjectives of said substance (i.e. lollypop,) or line of spoken words would be present originally, but removed from the final product never having existed.

Beside the point, neither of my two little desk go-to-dictionaries: The New Oxford Spelling Dictionary, 2014;   nor  The Merriam Webster Dictionary New Edition, 2004 include the word dis-candy.     My criteria for go-to-dictionaries is that they are small paperbacks that sit on a shelf above my computer and can be retrieved with one hand.

 

 

 

 

 

not your granny’s Columbus Day…

http://theoatmeal.com/comics/columbus_day

This article is excellent on the subject of Christopher Columbus and the “discovery of America.” It is well worth the read, and deserves an A+ for research and attribution, factual information based partially on bona fide original sources including Columbus’s own writing.

Bartolomé de Las Casas,  Dominican Friar and later Bishop, is the author of The Destruction of the Indies, which details the systematic horror brought to the Americas by Christopher Columbus.      De Las Casas is known as the Protector of the Indians, and was the Bishop of Chiapas, Mexico in the early sixteenth century.

My interest in this topic is the subject of the unpublished doctoral dissertation, which I spent ten years writing.   Unfortunately I did not complete the final draft, so it was never published.   However, before I die I hope to publish at least some of my work on my blog, at least.

Caribbean geography lesson…

Every now and then I like to get out a map and reassure myself that when not knowing the location of Yemen, or Utah, or Antiqua (for example) all I have to do is look it up on a map. A paper map, preferably, but sometimes even an online map will do.

So I wanted to see if Puerto Rico was really far out in the middle of the ocean someplace, or, as I suspected…in the Caribbean. So I did a search “Puerto Rico” and Bing zeroed in on a nice map of the island, in great detail of cities and even roads and topographical details like mountains. Zooming out to get the big picture…including the Pacific Ocean and all of Russia…the exact location of Puerto Rico became instantly remembered.

Looking Southward, from Florida, the island is sort of beyond Cuba, north of Venezuela, and in a line with other islands and chains of islands in the Caribbean, forming a line of defense reinforced by territories possessed by friendly allies: the French, Dutch, and British. This was perfect—especially back in the days of the conquest by Spain of the New World.

Actually the United States was interested in keeping the Spanish at bay as much as possible, while maintaining a strategic position of buffering between the British (our best friends forever) and “other” European or South American nations from getting any ideas. Or Japan…or anyone else.

The last good-size war the U.S. had with Spain was the Spanish-American War, which effectively booted the Spanish out of the area and declared US hegemony in the close-in islands, including Puerto Rico. It is true that the U.S. had a good line of defense in the Caribbean, and although U.S.-Cuban relations suffered during the Cold War…to the point where until the Cubans would acquiesce in being beaten by the U.S. Embargo, which effectively put Cuba and the Castro Dictatorship in its place as an oppressed and bullied island which “refused to straighten out” and endured sixty years or so of hardship and political hassles because of it.

At the end of the Spanish-American War in 1899, part of the spoils agreed on by the two nations was the prize of Puerto Rico…ceded to the U.S. by Spain. One of the results was that the Spanish-speaking citizens were required to speak and use English-only.

Puerto Rico is a U.S. Territory, and thus Puerto Rican citizens are citizens of the United States, and are entitled to vote in U.S. elections…except for the office of President. They elect representatives to the U.S. Congress, who are on the same basis as reps and Senators from the 50 other states.

One difficult hang-over from the early 20th Century is THE JONES LAW, which forbids Puerto Rico to receive shipments of any materials or products from any sources except on officially sanctioned United States registered Ships. The result of this is that now that Hurricane Maria has devastated the Puerto Rican island, the Jones Law limits what foreign aid they can receive. The U.S. Congress has the power to rescind or modify the law…but has so far declined. It may be nteresting to note that the Jones Law has been suspended in other U.S. ports under emergencies created by Hurricanes that hit Texas and Florida, as well as other U.S. controlled islands in the Caribbean.

The U.S. Navy Hospital Ship Comfort has, as of this Wednesday morning, been sent to Puerto Rico. The reasons for the delay apparently have been worked out, especially the excuse of the ship being “too big to park in the harbor…” and the hospital ship will anchor off-shore and apparently transfer patients from the mainland of the island by helicopter.

https://www.bing.com/maps?&ty=18&q=Puerto%20Rico&vdpid=202&mb=19.029888040912922~-69.22080993652341~17.464867724672842~-64.03526306152341&ppois=18.2491397857666_-66.6280364990234_Puerto%20Rico_~&cp=18.2491397857666~-66.6280364990234&v=2&sV=1&style=r&trfc=&lvl=7

Sticks and Stones and “Dotards”

Re the sticks-and-stones contest, following the old adage that “sticks and stones will break my bones, but names will never hurt me.”      Remember when some kid would spew off a string of bad words and mean but innocuous insults, and Mom or Grandma would sooth hurt feelings with the little rhyme…which in effect meant “if some kid hits you let me know, but if he calls you a bad name just laugh it off.”   Now like as not she might look around for someone to sue.

The North Korean leader Kim Jong-Il  has resurrected a good old  English word to toss at Donald Trump in insult: “dotard,” an Old-English word from the 14th Century. This cool new word, according to the excited media,  spurred linguists and English teachers all over the world to research the word—dotard.

Not that the word “dotard” is especially archaic, not to disappoint media writers that want to insinuate that Kim Jong-Il may be more knowledgeable than Donald Trump.  Within arms reach I find a variety of dictionaries, including a nifty little volume called New Oxford Spelling Dictionary:  The Writers’ and Editors’ Guide to Spelling and Word Division.  Edited by Maurice Waite, published by Oxford University Press, 2014.*

There, right in alphabetical order between the words “dotage” and “dot-com” is— “dotard,”   pronounced to rhyme with soldered, watered.    The etymology is from the same as:  doting,  one-who-dotes…as in a doting-grandfather.

It was a fun image to imagine the North Korean leader poring over his archaic English dictionaries searching for insults.

  • The most recent Merriam-Webster Dictionary (2004) also features the word “dotard” right in proper order.

 

 

The Hundredth Monkey (Re-blogged from Ellie’s Blog)

This blog just came to my attention this morning, and its my favorite blog today. Thanks SO much for the re-blog Ellie Haretuko…and for following my blog.

I recently read a study conducted in 1952. Reliability and the actual occurrence of the study even taking place was called into question, that it may just be a myth. Regardless the study enthralled me and mythical or not I enjoyed it. Here’s the gist of it.

Scientists were providing monkeys with sweet potatoes dropping them in the sand for the monkeys to collect. The monkeys loved the potatoes but hated the sand. One of the monkeys realised that she could rectify the problem by washing the sand off in the nearby stream, she taught the other monkeys. Through imitation they were able to learn. Now this in itself isn’t an anomaly, these creatures are intelligent and able to learn. What was surprising was that colonies of monkeys on other islands began doing the exact same thing without any ability to imitate through observation, as they were on neighbouring islands…

View original post 267 more words

Historiography at work

Historiography is the study of History.    It was one of my favorite mandatory seminars as a grad student at the University of Akron.

One of my friends and cohorts here in Blog Land, raised a very interesting point in  a comment on how the Historians of 100 years from now would treat the scenario in rage now of the Great Republican Plan to Obliterate the Obama Presidency.    Obviously all of us reading this will have no interaction whatsoever in the future century.   Who knows how the History of our age will be preserved, or how it will be reported to future generations.    The History of the Present hasn’t happened yet.

The Trump-Obama factionalism is too multi-faceted to tackle here.   However, the question is a good one, and leads me to ponder the basic differences between Now and Then…meaning past and future coverage of historical events.     There can be two designations here: Paper and Digital.

The most glaring difference is that what was written, published, in real books is that they were permanent.   Not necessarily the absolute authoritative sources on a given subject, but through a sort of consensus of opinions and research, and yes credentials.   In order to reach a thesis statement for a given publication, the writer presented his or her own ideas….something new, an alternate position.   There are always at least two sides to any proposition.

Here is a proposal that when it comes to Digital History, that which is presented over the internet by countless diverse sources, the information comes across only as permanent as the print-out a student or proponent, or indeed, opposition commentator, understands—or prefers to present as Truth or Falsehood—to their respective readership at any given time.

Digital History is much easier to alter, re-write, or inadvertently  distort  because of its fluidity…never permanent, always subject to a myriad of changes.    We see reports on the internet news channels… a statement made by an anchor person on CNN or Fox, MSNBC, BBC…at a given hour—that never airs again.

No one in their right mind for long will be able to watch Cable News constantly to keep up absolutely on the stream of information.    Remember when the internet was actually referred to as the Information Highway?   That was back in the 1980s, when major newspapers made the change from individual typewriters to the chaotic stream of News-all-the-Time.   Up-to-date means “constantly changing,” which isn’t necessarily a good thing.

 

Math is a human language (re-blogged from Simona Prilogan)

Math Time! I love math problems, but rarely solve them. The short video is interesting, think you will like it. 🙂   Sometimes the answer is right on the edge of my brain, although haven’t mastered the technique of really “getting it.”

 

a primer of selective History

Please open your books to page twenty-four
the teacher instructed, one morning …
look at the  ladies’ dressed in their finery,
feel free to smile at feathers and bustles,
and laugh out loud at the shoes!

Now let’s skip ahead to Chapter Seven,
where more ladies are seen at their work,
the clothing they wear is of buckskin,
embellished with feathers and beads (and pride,)
their raven hair in long silken braids.

Now the section titled “The Roaring Twenties.”
Days and years of lovely short-skirted ladies,
with bobbed hair and feathered  hats, called cloches.
They dance the Charleston, ducking the hit-men
who are ducking the likes of Elliot Ness.

The 1930s, when poverty reigned,
until saved by the richness and horrors of War.
The rich and beautiful, such as they were,
held on to their baubles and feathered their nests
as well as they could under the circumstances.

So now, we turn to the aftermath of The War
to the fiction-like era called The Cold War,
when living in spy novels was the norm…
and the games and palace intrigue surpassed
even the earlier times of the Kings…and Queens.

Now that we have closed the book of History
…a somewhat truncated collection of tales
that range from maybe to crazy-but-true…
we start or a new era which marvels
Alice’s Wonderland in scope and Fantasy.

In today’s time of making history…
a knowledge of the past is imperative.
If something of importance happens today,
it does not happen in a vacuum  at all
but is based on centuries of History!

So I leave you, boys and girls, with a note-worthy
suggestion….nay, a proclamation…
study your History from classical sources—
don’t depend on Twitter-twatter from pundits
who think History started last month.

© Sometimes, 2017
.

 

Deliyah…4-year-old reader of 1,000 books

https://www.washingtonpost.com/news/morning-mix/wp/2017/01/12/meet-daliyah-the-4-year-old-girl-who-has-read-more-than-1000-books/?utm_term=.6403ea387b35&wpisrc=nl_mix&wpmm=1#comments

Now here is an inspiring story out of the Washington Post this morning, a four-year-old who has apparently read one thousand (1,000) books so far. She hangs out at the Library of Congress.

Yes…I hear you in the back there mumbling about the veracity of this story…and I’ll bet you either 1) don’t personally know any of Deliyah’s peers, other pre-schoolers, that is… or 2)are not paying attention. This child is indeed remarkable and a great role-model for other children—and she is not unique. (Meaning one-of-a-kind, not as in the modern fancy of “unique” as a mere synonym for unusual, or great.)

Today’s children all over the world are smarter and more aware than at any time in history.    Peer into the bright, shining eyes of a child…in person or in photographs…to see the intelligence shining through.

They “know” things, information gleaned from television shows, or books, chatting with other children…and, of course, school.   Pre-school kids commonly know the alphabet and basic number figures, understand the details about the hippopotamus, orangatangs, and mocking birds.   They often even know how to spell those words.

 

Rules For Commenters…or Think First!

There should be a rule
on commenting protocol
requiring at least
(if not a working knowledge)
mini-common sense.

Every school age child
with a mite’s  intelligence
should have learned restraint
in matters of opinion…
at least a few facts.

No one should ever
consider as an expert
smart snappy comments…
an internet free-for-all
sans supervision.

Our Rule Number One:
Start out with a set of clues,
a few question marks,
a reasonably open-mind
and process of thought.

For Rule Number Two,
should be needless to expound,
an unspoken rule–
have proof, or at least
citations of information.

Who, what, when, where, why
How the commenter knows,
…at least Who Said So?
citation of source
and last—Who Cares?

© Sometimes, 2016