It’s Sunday, April 9, 2023, Easter, Passover, Ramadan, and National Chinese Almond Cookie Day. These are okay, but are a bit dry and need to be dipped into coffee.
An Easter groaner:
Q. What’s the Easter Bunny’s favorite restaurant?
A. IHOP!
A Christian Easter joke:
Jesus walks up to a crowd of people getting ready to stone a lady to death for committing adultery and says, “Whoever is without sin may cast the first stone.”
So this little lady walks up with a big rock and smashes it down on the poor woman and splits her head wide open.
Then the little lady dusts off her hands and starts walking away. Jesus shakes his head and says, “Mom, sometimes you really get on my nerves.”
And a Jewish Easter joke (posted six years ago):
This comes from the site Southern Jewish Humor, which gets the story from Eli N. Evans, who wrote The Provincials: A Personal History of Jews in the South:
Evans said he searched for the best example he could find of Southern Jewish humor. He told the story of a Jewish storekeeper in a small town who was approached by the Christian elders to show solidarity for their Easter holiday.
Mr. Goldberg was chagrined but when Easter came, after sunrise services on a nearby hilltop, the mayor, all the churchgoers, and the leading families in the city gathered in the town square in front of his store. The store had a new sign but it was draped with a parachute.
After an introduction from the mayor, at the appointed hour, the owner pulled the rope and there it was revealed in all its wonder for all to see: “Christ Has Risen, but Goldberg’s prices remain the same.”
He is risen!
He is NOT risen! Happy Passover!
It’s also National Gin and Tonic Day, National Baked Ham with Pineapple Day, Jenkins’s Ear Day (read the story about how a severed ear helped promote war), National Winston Churchill Day (he was made an honorary citizen of the U.S. on this day in 1963, only the second person ever to accrue this honor ), National Former Prisoner of War Recognition Day, Remembrance for Haakon Sigurdsson (The Troth), a pagan holiday, and, in Canada,Vimy Ridge Day.
Readers are welcome to mark notable events, births, or deaths on this by consulting the April 2 Wikipedia page.
Da Nooz:
*The NYT reports on Biden’s new initiative giving guidance for participation of transgender people in school sports. This clarifies some news reports yesterday that were a bit ambiguous:
Under the Department of Education proposal, “categorically” barring transgender athletes in that way would be a violation of Title IX, which prohibits sex discrimination at educational institutions that receive federal funding.
But it would give universities and K-12 schools the discretion to limit the participation of transgender students, if they conclude that including transgender athletes could undermine competitive fairness or potentially lead to sports-related injuries, a key part of the debate about transgender athletes in women’s sports.
Elementary school students would generally be able to participate in school sports according to their gender identity, under the proposal. But at more competitive levels, including high school and college sports, questions of physicality and fairness could prompt restrictions on transgender athletes.
The Education Department advised that schools would have to assess the ages of students and the level of the competition, as well as the nature of the sport itself. The impact may be different, for example, in track versus badminton.
The proposal must undergo a period of public comment. Once it is in effect, a senior official with the Education Department said, the federal government will be ready to investigate and enforce violations — up to and including withholding federal funding, if necessary.
That sounds fair enough, as there may be some sports (I don’t know of any, including badminton) in which men don’t have an average athletic advantage over women. But if there are, fine! However, do you go on averages or on individual performance. Does a really good woman badminton player get to play on men’s teams? If so, does a really good male badminton player get to play on women’s teams (assuming each claims that they’re a member of the opposite sex)? This would be a disaster.
*We now have opposite appellate court rulings on whether the FDA approval of the abortifacient drug mifepristone should be rescinded. A Texas judge says “yes”, while on the same day a judge in Washington State ssaid “no”. The Texas ruling bothers me as I don’t think it’s up to judges to rule on the safety of a tested and approved medication (and that’s the basis for the Texas decision). This case may well be headed to the Supreme Court. The WaPo says this:
“It is totally unclear how FDA is supposed to resolve this because this isn’t the way FDA does its job,” said Kirsten Moore, director of the advocacy organization Expanding Medication Abortion Access Project. “It shouldn’t have to say in these states the drug is approved, in these states the drug isn’t approved. That’s not tenable.”
The conflicting opinions probably mean a fast track for a legal showdown before a conservative Supreme Court that overturned the constitutional right to an abortion last June. If the high court were to uphold the ruling handed down by U.S. Judge Matthew J. Kacsmaryk in Texas, the FDA’s authority to vet and approve drugs, considered the gold standard around the world, could be permanently undermined, scholars said.
“This kind of Monday morning quarterbacking logic would allow courts to invalidate almost any FDA approval,” said Nathan Cortez, a law professor at Southern Methodist University, one of 19 legal experts who signed onto an amicus brief supporting the agency’s position that the pill had been properly approved in 2000.
. . .The FDA said in a statement Friday that it would appeal the decision.
“FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses,” the agency said.
And this is the most worrisome bit:
Ameet Sarpatwari, an expert on pharmaceutical policy and law at Harvard Medical School, said Kacsmaryk’s ruling is likely to encourage a spate of additional challenges.
“This opens the door to the courts’ second-guessing any FDA approval — especially for drugs for controversial areas like gender-affirming care, or PrEP for HIV prevention.”
If you read the Texas judge’s decision (see the footnote on page 2), you’ll see that he is making a medical decision that’s really based on politics. That’s why the Supreme Court cannot let this decision stand, as it applies not just in Texas, but in every state in America.
*The NYT has a deeper analysis of what’s going on with these rulings, concluding that even if the drug become illegal in the U.S., you’ll be likely to get it overseas. But here’s the skinny on the conservative judge’s ruling.
The lawsuit in the Texas district court, filed by a consortium of groups and doctors opposed to abortion, argues that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
The F.D.A. and the Department of Justice have strongly disputed those claims and said that the agency undertook rigorous reviews of mifepristone over the years that repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. They point to numerous studies showing that serious complications are rare, with patients needing hospitalization in less than 1 percent of cases.
In his ruling, Judge Kacsmaryk, who previously worked for a conservative Christian legal organization, repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion,” calling abortion providers “abortionists” and referring to a fetus as an “unborn human” or “unborn child.”
He appeared to agree with virtually all of the anti-abortion groups’ claims, writing: “Here, F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The F.D.A. has regulated mifepristone more stringently than many other drugs and applied a special framework of restrictions that is currently used for only 60 drugs in the country. In the case filed in federal court in Washington State, Democratic attorneys general from 17 states and the District of Columbia are seeking to eliminate that special framework of extra restrictions on mifepristone. Judge Rice did not grant that request in his ruling Friday but did order the F.D.A. not to do anything to limit current access to mifepristone.
Three bits of heartening news. First, withdrawing a drug’s FDA approval is a LONG proess, and could take months or years. Second, the other drug usually used in the two-drug combination, misoprostol, is approved by the WHO to be used by itself to induce abortion. Third, patients in all states could, without much difficulty, order high-quality drugs from agencies overseas like the telemedicine service Aid Access,
*Over at CNN, three young climate activists, , , and
President Joe Biden’s recent approval of the Willow Project in Alaska has alarmed many young people and once again made us question his seriousness about addressing the climate crisis before it is too late.
His decision to greenlight ConocoPhillips’ massive oil project isn’t just a betrayal of his promises on the campaign trail when he vowed to halt drilling on federal lands and to help the United States make the transition toward clean energy. It’s a betrayal of our generation’s future and of the millions of people suffering the impact of the climate crisis.
As if that were not enough, the Biden administration is auctioning off more than 73 million acres of waters in the Gulf of Mexico to offshore oil and gas drilling — double the size of the Willow Project if it goes ahead as planned. The president faced one of the greatest tests of his commitment to addressing climate change, and he failed. His administration must step up and commit to do better.
By the administration’s own estimates, the Willow Project on Alaska’s North Slope is projected to add 9.2 million metric tons of carbon pollution to the atmosphere per year. That’s the equivalent of adding 2 million gas-powered cars to the road every year — potentially for 30 years. Despite the large amounts of emissions that await, the administration — which faces pressure from unions, Alaskan lawmakers and some Native Alaskans who support the project — argues that refusing a permit for the Willow Project would trigger legal issues due to previously issued leases.
However, this decision not only contradicts Biden’s promises but also undermines the steps set forth by last month’s Intergovernmental Panel on Climate Change synthesis report. The IPCC, a panel of experts brought together by the United Nations, made it clear that the world already has too many fossil fuels in production to limit global warming to the relatively safe level of 1.5 degrees Celsius (2.7 degrees Fahrenheit) unless swift action is taken.
Yep, this is one of the most arrant lies among Biden’s campaign promises. The other, which he couldn’t do anything about, was to “reach across the aisle” to forge legislative consensus between Democrats and Republicans.
*Here’s a gruesome Easter story for you from the AP, and shows how crazy religion can make people behave:
Eight Filipinos were nailed to crosses to reenact Jesus Christ’s suffering in a bloody Good Friday tradition, including a carpenter, who was crucified for the 34th time with a prayer for Russia’s invasion of Ukraine to end because it has made poor people like him more desperate.
The real-life crucifixions in the farming village of San Pedro Cutud in Pampanga province north of Manila resumed after a three-year pause due to the coronavirus pandemic. About a dozen villagers registered but only eight people showed up, including 62-year-old carpenter and sign painter Ruben Enaje, who screamed as he was nailed to a wooden cross with a large crowd watching in the scorching summer heat.
In a news conference shortly after his crucifixion, Enaje said he prayed for the eradication of the COVID-19 virus and the end of Russia’s invasion of Ukraine, which has contributed to gas and food prices soaring worldwide.
A photo. Yep, they’re really nailed up there!
Meanwhile in Dobrzyn, Hili’s striving to be an intellectual:
Hili: I see complexity.A: And what?Hili: I’m trying to analyse its component parts.
Hili: Widzę złożoność.Ja: I co?Hili: Próbuję ją rozłóżyć na czynniki pierwsze.
And a photo of baby Kulka
********************
From America’s Cultural Decline into Idoicy. Get the reference?
From Nicole:
From Jesus of the Day:
From Masih. I doubt these girls are faking it. Sound up.
These girls can not breathe.
Again Iranians are witnessing series of chemical attacks taking place across Iran where students are being poisoned. This terror attack is their revenge against school girls standing up to the mullahs. #WomanLifeFreedom
pic.twitter.com/U08th2Eg1E— Masih Alinejad 🏳️ (@AlinejadMasih) April 8, 2023
From Amy; Jerry the Cat is still taking care of the de Havilland Aircraft Museum:
Jerry has had a hard day @deHavMuseum greeting visitors and accepting strokes and taking his #museumcat role seriously. Here he is quietly having a doze on volunteer’s lap. Come and see him and our #dehavilland collection. pic.twitter.com/fHSsyGCPxS
— de Havilland Aircraft Museum (@deHavMuseum) March 15, 2023
AOC clearly wants non-medically-treated transgender women to compete with biological women. In other words, she favors the demise of women’s sports. Such is the conflicts that beset “progressives”:
Absolutely no reason for the Biden admin to do this. It is indefensible and embarrassing.
The admin can still walk this back, and they should. It’s a disgrace https://t.co/3aUR0dnS5Q
— Alexandria Ocasio-Cortez (@AOC) April 6, 2023
From Simon, who says, “Still the greatest”. Muhammad Ali gives the host a boxing lesson, demonstrating the Ali Shuffle:
the goat's footworkpic.twitter.com/yWfu8grJmv
— Roots of Combat (@RootsOfCombat) April 2, 2023
A tweet I found. In DodoLand, all ends well, and this caged tiger finally gets to roam free:
Tiger forced to do tricks her whole life is thrilled to scratch on a tree for the first time 🧡 pic.twitter.com/duVw0bKL53
— The Dodo (@dodo) April 6, 2023
From the Auschwitz Memorial, a boy (wearing lederhosen!), dead at twenty:
9 April 1923 | A German Jew, Sigmund Wolfgang Haberhauffe, was born in Kropp bei Schleswig.
In #Auschwitz from 19 February 1943
No. 103757
He perished in the camp on 30 December 1943. pic.twitter.com/igGLgEAIFr— Auschwitz Memorial (@AuschwitzMuseum) April 9, 2023
Tweets from Dr. Cobb. First, Moose on the loose!
A young moose caused a stir when it strolled through the front doors of a Providence Alaska medical facility Thursday afternoon in Anchorage — apparently without an appointment. (Video provided by Providence Alaska) https://t.co/OQVCNju8Oh pic.twitter.com/lAe9025J0X
— Anchorage Daily News (@adndotcom) April 7, 2023
All you can eat potato chips??? Served bread butter and sauce so you can make potato-chip sandwiches! OY! I repeat: the Brits don’t know the meaning of a “proper sandwich”.
It’s all happening in Hull pic.twitter.com/eIzYTnqpP0
— The Lancashire Hotpots (@thehotpots) April 7, 2023
Mars! Enlarge the photo to see the dust devil; the thread shows how this was made:
Two days ago on Sol 755 @NASAPersevere sent back these amazing views of Jezero crater from the outer fans of Jezero delta.
Even a huge dust devil happened to swirl around near the crater rim. https://t.co/pybXofudfE
Credit: NASA/JPL-Caltech/Simeon Schmauß pic.twitter.com/oVKGYleF1Y— Simeon Schmauß (@stim3on) April 7, 2023
My favorite Easter joke:
For anyone who hasn’t heard it, here is my favorite:
Jesus walks into a hotel, puts four nails on the counter and says “can you put me up for the night?”
The Simpsons episode 186 – including the actual voice of Stephen Jay Gould, in fact – “Lisa the Skeptic”, has a variant on the “risen” joke :
For a number of days, (IIRC), the town is led to believe “the end is near”, and all gather at sundown for it. A figure appears, and proclaims :
” “Prepare for the end… the end of high prices!” and is hoisted over to the entrance of a new discount shopping mall,”
https://simpsons.fandom.com/wiki/Lisa_the_Skeptic
The Washington Post is quoted as publishing this: “If the high court were to uphold the ruling handed down by U.S. Judge Matthew J. Kacsmaryk in Texas, the FDA’s authority to vet and approve drugs, considered the gold standard around the world, could be permanently undermined, scholars said.”
This sentence scares the hell out of me. It means that any ideological judge, without any medical or pharmaceutical training, can revoke the approval of any drug, not just one that induces abortion. This can be the opening wedge for a judicial coup to ban contraceptives on grounds of drug safety, another Christian nationalist goal. Of course, such folks of means will have no trouble securing these drugs on the black market. If the Supreme Court lets the Texas decision stand, it will be directly responsible for tearing the nation apart. There will be active defiance of the ruling through Prohibition style bootlegging, which will result in the breakdown of the rule of law. The country could become a right-wing theocracy through a judicial coup. This will turn out to be Trump’s greatest accomplishment via his Supreme Court appointments and the complicity of the Republican Party.
Yes, regardless of abortion, it is indefensible that a judge with no medical or pharmaceutical knowledge at all would judge about drugs and overrule the FDA. That should be an absolute nono. An absolute blerry f….ing nono.
For all clarity: an absolute effen nono.
I cannot feel stronger about this clown show.
This judge should be impeached right away, ASAP.
It chafes to say it, but it looks like the Willow project had to happen and by letting it go ahead the way they did the Biden admin. managed to limit the scope of the project.
ConocoPhillips had a long-standing license to one day be able to develop the oil field in Alaska, and they would have sued to be allowed to do so. The administration calculated that they would have lost the case, we would shoulder a heavy fine, and the project would go ahead I think without limitations. But by doing it they way they did, the administration managed to get ConocoPhillips to agree to develop 3 out of 5 of the planned drilling sites. I know it sucks, but that was the situation as I understand it.
Thanks for this added information. A silver lining, anyway. I hope the Biden administration can get in front of this and explain how their hands were tied; nuance is always difficult to communicate.
I guess the war in Ukraine and the banning of Russian oil and gas to Europe might have something to do with that? I really don’t know.
On this day:
1609 – Philip III of Spain issues the decree of the “Expulsion of the Moriscos”.
1682 – Robert Cavelier de La Salle discovers the mouth of the Mississippi River, claims it for France and names it Louisiana.
1860 – On his phonautograph machine, Édouard-Léon Scott de Martinville makes the oldest known recording of an audible human voice.
1865 – American Civil War: Robert E. Lee surrenders the Army of Northern Virginia (26,765 troops) to Ulysses S. Grant at Appomattox Court House, Virginia, effectively ending the war.
1939 – African-American singer Marian Anderson gives a concert at the Lincoln Memorial after being denied the use of Constitution Hall by the Daughters of the American Revolution.
1945 – The United States Atomic Energy Commission is formed.
1947 – The Journey of Reconciliation, the first interracial Freedom Ride begins through the upper South in violation of Jim Crow laws. The riders wanted enforcement of the United States Supreme Court’s 1946 Irene Morgan decision that banned racial segregation in interstate travel.
1959 – Project Mercury: NASA announces the selection of the United States’ first seven astronauts, whom the news media quickly dub the “Mercury Seven”.
1967 – The first Boeing 737 (a 100 series) makes its maiden flight.
1969 – The first British-built Concorde 002 makes its maiden flight from Filton to RAF Fairford.
1992 – A U.S. Federal Court finds former Panamanian dictator Manuel Noriega guilty of drug and racketeering charges. He is sentenced to 30 years in prison.
2003 – Iraq War: Baghdad falls to American forces.
2017 – After refusing to give up his seat on an overbooked United Express flight, Dr. David Dao Duy Anh is forcibly dragged off the flight by aviation security officers, leading to major criticism of United Airlines.
Births:
1806 – Isambard Kingdom Brunel, English engineer, designed the Clifton Suspension Bridge (d. 1859).
1821 – Charles Baudelaire, French poet and critic (d. 1867).
1893 – Victor Gollancz, English publisher, founded Victor Gollancz Ltd (d. 1967). [Published George Orwell’s early books, but refused to publish Homage to Catalonia, ending their relationship.]
1898 – Paul Robeson, American singer, actor, and activist (d. 1976).
1921 – Mary Jackson, African-American mathematician and aerospace engineer (d. 2005). [NASA’s first black female engineer, she is one of the protagonists in the 2016 film Hidden Figures and features in the book it was based on.]
1926 – Hugh Hefner, American publisher, founded Playboy Enterprises (d. 2017).
1932 – Carl Perkins, American singer-songwriter and guitarist (d. 1998).
1933 – Jean-Paul Belmondo, French actor and producer (d. 2021).
1937 – Valerie Singleton, English television and radio host.
1967 – Sam Harris, American author, philosopher, and neuroscientist.
1977 – Gerard Way, American singer-songwriter and comic book writer. [ “When I was a young boy, my father / Took me into the city to see a marching band…” ]
“You don’t beat the Duck of Death by living longer; you beat the Duck of Death by living better: [With apologies to Randy Pausch.]
1626 – Francis Bacon, English jurist and politician, Attorney General for England and Wales (b. 1561).
1882 – Dante Gabriel Rossetti, English poet and painter (b. 1828).
1959 – Frank Lloyd Wright, American architect, designed the Price Tower and Fallingwater (b. 1867).
1976 – Phil Ochs, American singer-songwriter and guitarist (b. 1940).
1978 – Clough Williams-Ellis, English-Welsh architect, designed Portmeirion (b. 1883). [The iconic 1960s TV show The Prisoner used Portmeirion as the filming location for “The Village”.]
2011 – Sidney Lumet, American director, producer, and screenwriter (b. 1924).
2021 – Prince Philip, Duke of Edinburgh (b. 1921).
I guess the moose was looking for the National Elk Service…?
I tend to agree with you on the sandwiches Jerry, although it depends on where you’re getting it from. There are some great sandwich places all over the UK, but the Americans consistently raise the sandwich artform to a higher level.
I have to say that I’m embarrassed that any UK establishment is selling such cack! And for £12.95 too! I very occasionally had a crisp sandwich as a kid, but all you can eat? Euuurrgh. To be fair though, Hull is not known for its culinary sophistication.
Re American sarnies – I was in NYC last week and visited Katz’s with my two daughters. We had a reuben, a brisket and corned beef on rye, and I’m sorry to say we weren’t impressed. The meats, especially brisket and pastrami were the tenderest I’ve ever eaten, just lovely. But we were all put off by the sheer volume of meat, it became a chore to eat by the end. Also I found the pickles just horrible, inedible in fact. I’ve never tasted any so salty. Each to their own, but we were a bit disappointed. It was expensive too – 3 sarnies, 3 diet cokes, 2 slices cheesecake came to about $125!
Going back to Hull, it can also be a bit rough in places. I once went there with my mate to stay a couple of days with his dad. He was out when we arrived, so we found a local pub. We had to knock on the door to get in (should’ve clocked on then really), and on entering it was full of semi-comatose people lied about the place. We were the only people who looked remotely employable, causing an angry group to surround us. We were saved by the landlord, who explained we looked like undercover police and ushered us quickly out the back door. Only later did his dad tell us not go near the pub, because it was a known drug den. The police had an ‘arrangement’ not to bother them as they would rather keep the bad ‘uns off the streets and in one place.
The essential thing about a sandwich is that it is portable and can be eaten anywhere. A culinary masterpiece that happens to involve two slices of bread but that cannot be taken out of the establishment in which it was made and eaten in the park, or at your desk, or on a bus without too much fuss misses the point of being a sandwich.
On the subject of Hull
My cousin went to Hull and therefore I concur.
I make no defence of the British sandwich but traditionally the bit in the middle is there to help the bread go down.
My mother was famous for sandwiches in which you could peel apart the slices of bread and still have difficulty detecting the filling. 2oz of ham could feed a dozen easily – at least in my memory.
See–that’s what I mean!
+1 for the Blackadder reference! Where Melchett is concerned I’m always tempted to borrow a phrase from Richard Dawkins:
General Sir Anthony Cecil Hogmany Melchett of Blackadder 4 is arguably the most brilliant character in all fiction.
Stephen Fry is a comedy genius in that series, in fact all the main actors are. It’s comedy perfection.
BTW – I haven’t been back to Hull since, other than to drive through. Looking at the positives, I suppose I can say that I have been to Hull and back, and based on my experience that’s unlikely to be the case for every visitor.
My very favorite Easter story, by David Sedaris. Enjoy!
http://scottduncan.free.fr/blog/jesus_shaves.pdf
Gotta’ love those geniuses being crucified in the Philippines. Aren’t there safer ways to commemorate the mythic event? How about an Easter egg coloring contest instead?
Just a note about FDA approval. It means that the drug company can “market” i.e., label, advertise, and promote the drug for the indications authorized in the FDA approval document, called a notice of compliance. The FDA scrutinizes all information in the package insert and on the company’s website like dose, warnings, how to treat side effects, etc. It can order changes including, if new information comes up, removal of a permitted indication.
There is nothing to stop doctors from prescribing drugs for “off-label” purposes, though, nor pharmacies from dispensing them, nor manufacturers from filling orders from drug stores for resupply. Two familiar examples are aspirin to prevent heart attacks and hormones for gender affirmation. Neither of these are FDA-compliant uses and neither can be promoted by the manufacturers for those purposes yet are of course widely used. It was therefore ironic to read the hand-wringing that a judge with a political agenda could interrupt gender care by rescinding FDA approval of hormones, a status these drugs do not now enjoy!
FDA approval (and similar approval in other countries) is intended to prevent the Pharmas from making misleading or false claims to doctors about the drugs they make. It does not grant “permission “ to sell the drug.
There are medical legal concerns about off-label use but if there is good scientific evidence that the drug works, as there is for off-label aspirin but not for off-label hormones, the doctor is on safe ground. Indeed, a doctor who didn’t prescribe aspirin to a suitable patient with heart disease could not fall back on the defence that Bayer had never bothered to get a notice of compliance to market its aspirin to prevent heart attacks. Indeed, since aspirin is not widely used for headaches anymore, it is likely that most of the aspirin and generic ASA sold today is for off-label use.
So if FDA approval of mifepristone is rescinded, it will be a business decision by the manufacturer as to whether or not it continues to manufacture and distribute it. There will be no legal prohibition (except in states where abortion is illegal, of course.)
Big Pharma will surely lobby strongly against this decision. Getting notice of compliance takes many millions of dollars in trials and paperwork, on top of the expense of developing a drug in the first place. To risk all this investment going up in smoke at the stroke of a judge’s pen will deter the development of new drugs. For drugs that don’t sell themselves—and maybe an abortifacient is one that does—FDA approval is essential to getting them to market so the scientists can start earning their keep.
FDA regulation is not my thing, exactly, I’m a patent attorney, but I work with pharma clients, and I think you are mistaken. A “Notice of Compliance” is a Canadian drug approval, not a US one: the US document is an approved New Drug Application, or NDA.
21 USC 355:
“(a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.”
Mifepristone, without an NDA, would be a “new drug” and therefore not legally able to be sold; technically “in interstate commerce”, but in practice at all.
Off-label prescription of approved drugs is significantly different from the sale of unapproved drugs: the FDA does not regulate the practice of medicine as such, so if a physician wants to prescribe an approved drug for an unapproved use, he/she is free to do so vis-a-vis the FDA. But the FDA will pursue the sale of unapproved drugs, which is why people have gone to places like Mexico for treatment with laetrile or other quacky anticancer “drugs”.
Part of the issue with mifepristone is that it has non-abortifacient uses, such as for the treatment of Cushing’s disease (Corcept has an NDA for that indication, calling its product KORLYM, and Teva has an abbreviated NDA (ANDA) for a generic). It seems to me that even if the NDA granted to Danco for MIFEPREX, which is the original approval as an abortifacient, and the corresponding ANDA to GenBioPro, are revoked, then as long as the NDA for KORLYM remains in effect, mifepristone will be available, albeit at 300mg instead of the 200 mg for MIFEPREX and generics. Whether physicians will want to use KORLYM to replace MIFEPREX, and whether they’ll be able to get it, is an issue I can’t comment on.
As for aspirin, it is not subject to these rules because it is an old drug, long predating the current laws.
Whichever way, Mifepristone and Misoprostol will be used, whether legally or provided by the black market. If a woman wants an abortion she will generally get it, regardless of ridiculous ‘laws’. I see a grand black market opening. If I were a US-ian I would stock these drugs now. Comfortable retirement guaranteed.
Only the young teenager or the religiously enclosed (imprisoned) might not have access to these drugs. And might recourse to the dangerous ‘back alley’ abortions.
Of course, more liberal abortion laws would be much better. The US SC is completely out of touch.
I’m no expert here, but I know that doctors prescribing off-label must have a clear rationale for doing so. For clarity, I just pulled this text regarding off-label prescribing from the AMA Journal of Ethics:
This practice is justified when scientific evidence suggests the efficacy and safety of a medication for an indication for which it does not have FDA approval and when the practice is supported by expert consensus or practice guidelines
It would, of course, be simple to demonstrate a clear scientific justification for the use of mifepristone as an abortifactant. However, how many doctors will feel comfortable prescribing it off-label for abortion, given the current social and political climate?
I agree 100% that doctors can prescribe it legally and ethically, but seriously, how many will be prepared to do so? Claiming doctors will still be able to prescribe it seems to me like wriggling out of the question on a technicality. Yes, the option to prescribe it remains, but that doesn’t mean that access to the drug will be unaffected. Far from it.
If I were a doctor, I would be VERY wary of prescribing it off-label for abortion. In fact, I probably wouldn’t prescribe, as I’d be far too worried about legal issues and reputational damage screwing up my professional future, ESPECIALLY if I worked in one of the crazy anti-abortion states. It’s unrealistic to expect doctors to do otherwise.
Like I said, I’m no expert, and I would love someone to tell me why I’m wrong. But surely, it shouldn’t take a genius to predict that access to this drug would drop precipitously.
Love, love, love the “but Goldberg’s prices remain the same” joke. I have shared it with others each year since I first heard it from you, Ceiling Cat. Thanks for posting it again today.
Yes, that was a good one, sadly with the inflation, even Goldberg’s prices have risen. And don’t get me wrong, the inflation is world wide and has little to do with the present US administration, if anything it tried to curb it, although officially that’s up to Jerome Powell, arguably the most powerful man in the US.
Without getting into more speculation about what’s wrong with these Iranian girls, I wanted to send a nice shout-out to the male medical workers attending to them. Their calm supportive tones of voice as they do their assessments are a good model for professional communication in a fraught, uncertain environment. The contrast with.outside the clinic is stark.
Two points of fact:
1). Patients with psychosomatic illness are not “faking.”
2). Contrary to Ms. Alinejad’s assertion, these women are most assuredly breathing. You have even one patient who isn’t breathing it’s controlled pandemonium. Plural means literally a disaster.
A regime that poisons its citizens -if true- will not last long, I’d think. The Iranian Mullahs appear to lose it, it seems, will Iran be able to throw over the Mullahs and become a civilised state?
I hope so, but I fear I’m wrong. The Mullahs appear to have a kind of iron grip on power.
I recall this Jewish joke from my childhood ‘Readers’ Digest’ days: A tourist in Tel Aviv needs his watch fixed, and walks by a shop with watches in the window. He walks into the shop and asks the shopkeeper, “Do you fix watches?” The shopkeeper says, “No. We do circumcisions here.” The tourist says, “Then why do you put watches in the front window?” The shopkeeper replies, “What would you put in the window?”