Breaking News: Pfizer says new pill cuts COVID hospitalizations, deaths by nearly 90% and Vaccines And The Limits Of Da’as Torah By Stephen Hirsch and The Quest To Find The Schindler Of Kristallnacht By Rabbi Hanoch Teller
Yehuda Lave is an author, journalist, psychologist, rabbi, spiritual teacher, and coach, with degrees in business, psychology and Jewish Law. He works with people from all walks of life and helps them in their search for greater happiness, meaning, business advice on saving money, and spiritual engagement.
Pfizer says new pill cuts COVID hospitalizations, deaths by nearly 90%
Pfizer says new pill cuts COVID hospitalizations, deaths by nearly 90%
US drugmaker touts preliminary survey results indicating effectiveness of antiviral treatment, says it will seek approval from FDA, international regulators as soon as possible
WASHINGTON (AP) — Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% as the drugmaker joins the race to bring the first easy-to-use medication against the coronavirus to the US market.
Currently all COVID-19 treatments used in the US require an IV or injection. Competitor Merck's COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company's study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months.
Researchers worldwide have been racing to find a pill against COVID-19 that can be taken at home to ease symptoms, speed recovery and reduce the crushing burden on hospitals and doctors.
Pfizer released preliminary results Friday of its study of 775 adults. Patients taking the company's drug along with another antiviral had an 89% reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. In the comparison group, 7% were hospitalized and there were seven deaths.
"We were hoping that we had something extraordinary, but it's rare that you see great drugs come through with almost 90% efficacy and 100% protection for death," said Dr. Mikael Dolsten, Pfizer's chief scientific officer, in an interview.
Study participants were unvaccinated, with mild-to-moderate COVID-19, and were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days.
Pfizer reported few details on side effects but said rates of problems were similar between the groups at about 20%.
An independent group of medical experts monitoring the trial recommended stopping it early, standard procedure when interim results show such a clear benefit. The data have not yet been published for outside review, the normal process for vetting new medical research.
Top US health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated — and many more globally — effective, easy-to-use treatments will be critical to curbing future waves of infections.
A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic at the Reading Area Community College in Reading, Pennsylvania, September 14, 2021. (AP Photo/Matt Rourke, File)
The FDA has set a public meeting later this month to review Merck's pill, known as molnupiravir. The company reported in September that its drug cut rates of hospitalization and death by 50%. Experts warn against comparing preliminary results because of differences in studies.
Although Merck's pill is further along in the US regulatory process, Pfizer's drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer's drug did not have any similar restrictions. The Merck drug works by interfering with the coronavirus' genetic code, a novel approach to disrupting the virus.
Pfizer's drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.
The drug, which has not yet been named, was first identified during the SARS outbreak originating in Asia during 2003. Last year, company researchers decided to revive the medication and study it for COVID-19, given the similarities between the two coronaviruses.
The US has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they have to be given by IV or injection at hospitals or clinics, and limited supplies were strained by the last surge of the delta variant.
Photo Credit: Wikimiedia Commons A destroyed shul in Berlin.
We mark the solemn anniversary of Kristallnacht, the anti-Semitic whirlwind of murder, torture and destruction that struck hundreds of cities, towns and hamlets across Germany, Austria and the occupied Sudetenland on November 9-10, 1938.
Though "Kristallnacht" means simply "Crystal Night" in English, German historians eschew the name, which minimizes the terrorists' pervasive butchery, an added crime one historian called "murder by euphemism."
But semantics cannot disguise the devastation wrought with the murder of hundreds of Jewish people, brutalization of hundreds of thousands more, torching of Torah scrolls and synagogues, shattering of windows of Jewish-owned stores, and sacking of businesses, cemeteries, schools, old-age homes and orphanages.
This anniversary of the violence that led into the Holocaust also recalls an entire society complicit in the most horrific "ethnic cleansing" the world has ever known.
I have researched and documented hundreds of stories concerning heroism and survival in the face of the most depraved and evil campaign in human history. My work has focused primarily upon children wrenched from their parents so young they would not have survived had it not been for the righteous gentiles who harbored them.
But my initial search for heroes of Kristallnacht came up empty. Surely there must have been upright Germans who shielded their Jewish friends and neighbors from the angry mobs seeking them out. I felt compelled to find the "Schindlers" of Kristallnacht.
Sadly, my detailed research yielded only a pitiful, nameless few.
This sends an ominous message today, as Americans feel an increasing sense of division and enmity toward those with differing political views. Stress fissures are widening even between friends and coworkers, as name-calling and bigotry slides by, and tolerance recedes.
While the evil extremes of Nazi Germany go way beyond our current climate, its history shows how a civilized society can retreat toward uncivilized behavior. Far too many incredulous German Jews ignored or denied the warning signs evident in 1933 when the Nazis came to power. By Kristallnacht, it was too late for the 30,000 Jews, including the elderly, women and children, who were tortured, deported to concentration camps and often murdered. Factually, it was too late for any Jew that was left.
Tens of millions of Germans were presumably appalled by what they witnessed on November 9th and 10th. The pogrom was out in the open, and lasted through broad daylight in hundreds of communities with even the smallest number of Jewish residents. In the words of a Hitler Youth member, "After Kristallnacht, no German old enough to walk could ever plead ignorance of the persecution of the Jews, and no Jews could harbor any delusion that Hitler wanted Germany anything but Judenrein, clean of Jews."
And yet I found one rescuer with a name, Father Bernhard Lichtenberg, who met his fate awaiting deportation to the Dachau concentration camp.
The rest leave only a wisp of identities, or none: A maid in Munich named Anna who arranged a taxi for her employer's escape, and an architect in Würzberg named Gourdon who did not close his door when a Jewish friend snuck over seeking shelter. The greatest Kristallnacht deliverer I came across was a nameless Berlin businessman who quartered 11 Jewish men.
The dearth of known defenders occurs despite a desperate desire by Jews to honor their protectors. We know that Leopold Pfefferberg badgered every writer who entered his Los Angeles leather-goods store to write the story of his rescuer, Oskar Schindler. He finally persuaded Australian novelist Thomas Keneally (who had innocently entered the shop to buy a briefcase) to write the book that became known as Schindler's List. Subsequently, Pfefferberg (Americanized to "Page") pestered Steven Spielberg to turn the book into a movie. When the filmmaker was working on "Jurassic Park," Page admonished, "Stop playing around with dinosaurs. I promise you, you'll get an Oscar for Oskar." (The film won seven Oscars, including Best Picture.)
In 1962 the Israeli Parliament enacted a law to recognize the "Righteous Among the Nations," non-Jews who took great risks to save Jews during the Holocaust. Ever since, hundreds of employees and far more volunteers at Yad Vashem work assiduously to discover and recognize worthy individuals.
And yet, I never found the Schindler of Kristallnacht I was looking for. One scholar I consulted attributed my failure to a post-war reluctance to highlight acts of courage under Nazi dominion, so as not to incite passive collaborators who claimed nothing could be done.
Yet in the German population of the time, one would expect to find more resistance to evil than the far less than one-out-of-ten-million citizens who were identified. The answer cannot be that there were no upright people in Germany. Schindler was a dishonest businessman, a womanizer, a boozer and an opportunist. But when he saw the chance to conduct himself humanely, he did so.
Eighty-plus years later, as American political foes accuse opponents of lies and hurl epithets with little restraint, we should remember to stand up to incivility, and practice charity of spirit. The ultimate victims of denigration include not only its targets but we who abet and observe it.
I was raised secular. I went to Hebrew school in order to have a bar mitzvah party and pretty much took the money and ran. Torah was not a part of my life at all. I married a non-Jewish woman, had two daughters with her and lived a completely secular, basically goyish life until I was 41.
When I was 41, I left my wife and started a new life as a frum Jew, which I continue to this very day.
One consequence of leaving Torah in my rear view mirror at age 13 was that I have a very hard time learning Talmud. Since I never went to yeshiva for a single day in my life, I missed those formative years when I could have learned how to learn Gemara on my own, without the Artscroll, let alone Shulchan Aruch or Mishnah Berurah.
So, a question for you: Would you come to me for a p'sak halacha? Of course not, that would be the height of foolishness.
Now, I have been making a living as a database architect for about 25 years now or so. If you have a shayla on how to structure a database, yes, I would be more than happy to posken for you. Because in that sugya, I do know very well what I'm talking about and would give you a teshuva you could rely on.
I've heard that there are some who look to da'as Torah to determine whether or not they should get one of the Covid-19 vaccines.
My jaw dropped when I heard this. While I hold those with da'as Torah in the highest regard, to ask men who have never taken a biology course in their lives, who have spent as much time in medical school as I have in yeshiva, to posken medicine is misguided.
This is over and above the fact that the basic halacha is that we listen to doctors. While there are certainly dissenters out there who dispute the medical consensus, the fact is that the medical consensus is overwhelmingly pro-vaccine and those dissenters are the tiny minority.
If you don't believe me, look at the list of medical professionals, men and women with medical training, who sign their names in an ad that has run in this very newspaper, staking their reputations on the fact that the vaccine is safe and effective. Are there any resha'im on that list that I'm not aware of, any false eidim on that list that I'm not aware of?
If there's not (and I'm certain that there aren't any), then you should ask yourself, if you are a vaccine refusenik, why are they doing that? Why are they signing their names to this ad? Why are they bothering?
And if you're a refusenik, and you can't answer those three questions in a manner that clearly defines them as resha'im, then maybe you should consider getting vaccinated.
