#991: Contraception and the Future of Medical Research

Of all the many “hats” I have worn over the past half-century - rabbi, political historian and speech-writer, author, blogger and essayist, occasional actor, professional “Hollywood Brat,” and medical ethicist - it’s this last one which has always given me the greatest sense of purpose, pleasure, and pride. Why? Well, simply put, it’s the one pursuit that has always given me the feeling that perhaps - just perhaps - I’m making a difference. I mean, week in, week out for more years than I can remember, I have been charged with the task of vetting medical research “informed consent” forms (ICFs) whose purpose is to safeguard the rights of men, women, and children who might well become volunteer participants in serious clinical trials.  It is my job - along with a host of brilliant medical specialists, surgeons, scientists, and bioengineers who work for the Institutional Review company called Advarra - to further the aims of medical research in fields ranging from oncology and infectious diseases to gynecology, gastroenterology, and dozens of other ologies in the pursuit of progress.  Indeed, it is the greatest of all honors to be the enemies of those who reject science . . . who believe that Dr. Anthony Fauci is a criminal who should be put in jail for crimes against humanity.  We who gladly labor in the vineyards of medical ethics are the ones, after all, who were instrumental in making sure that various COVID-19 vaccines got into the veins of people in record time . . . thus saving tens of millions of lives.

 This past Wednesday (June 5, 2024), while spending the better part of the day vetting several Informed Consent Forms (ICFs) dealing with trials concerning various diseases and syndromes, I was keeping an eye on a computer “crawler” keeping me up-to-date on a particular vote in the U.S. Senate; one dealing with the future of contraception. In order to understand just what it was that the Senate was voting on this past Wednesday, one must first recall something Supreme Court Justice Clarence Thomas wrote in his concurring opinion overturning Roe v Wade (Dobbs v. Jackson Women’s Health Organization et al ): “[The Court] should reconsider” all three decisions, saying it had a duty to “correct the error” established in those precedents (Griswold v. Connecticut, a 1965 decision that declared married couples had a right to contraception; Lawrence v. Texas, a 2003 case invalidating sodomy laws and making same-sex sexual activity legal across the country; and Obergefell v. Hodges, the 2015 case establishing the right of gay couples to marry.) Then, Justice Thomas wrote, after “overruling these demonstrably erroneous decisions, the question would remain whether other constitutional provisions” protected the rights they established.

The bill the senate was voting on this past Wednesday, was the Right to Contraception Act (S1999), sponsored by Massachusetts Democrat Edward Markey and cosponsored by nearly every Democrat in that body. Its purpose in being brought to the floor for an up-or-down vote at this particular time was as clear as clear can be: to force Senate Republicans (as well as those in the House where there is a companion bill) to go on the record as to whether they are for or against permitting women to have legal access to virtually any form of birth control (sans complete sexual abstention). From a political point of view - and in an election year - it was a great idea: make Republicans accountable. According to the national poll 538, “, . . . around 90 percent of Americans said condoms and birth control pills should be legal in “all” or “most” cases, and 81 percent said the same of IUDs (intrauterine devices). And, there is very little difference in support for the legality of each of these contraceptives across party lines.’ It seemed like a slam dunk for the Democrats.’

But what did the Republicans do? Instead of voting against Senator Markey’s bill and exposing themselves as a bunch of retrograde Luddites, they voted to block action on the legislation. Senate Republicans, aware that contraception access is overwhelmingly popular even with their own voters, pretended their “no” votes were meaningless. “This is a show vote. It’s not serious. It doesn’t mean anything,” said Sen. John Cornyn, R-Texas. More than 20 GOP senators signed a statement from Sen. Rick Scott, R-Fla., declaring “There is no threat to access to contraception… and it’s disgusting that Democrats are fearmongering on this important issue to score cheap political points.” Sen. Josh Hawley, R-Mo., baselessly claimed the bill could be applied to protect access to abortion pills. He also scoffed at the notion that Griswold v. Connecticut, the 1965 case that struck down state criminal bans on the sale of birth control to married couples, is in danger. “Nobody’s gonna overturn Griswold,” he said. “No way.”

 What’s that old retort from childhood? Liar, liar, pants on fire . . . “  I have to believe that those Republicans old enough to remember this verse also remember its response: I don’t care, I don’t care; I can buy another pair.  The final vote was 51-39 on this procedural issue that required at least 60 senators in order to move forward. But they are unwilling to go on the record; to put their votes where their mouths are, thus facing the political consequences of their cowardice. In the main, GOP lawmakers said the measure was too broad as well as unnecessary. Alaska Sen. Lisa Murkowski and Maine Sen. Susan Collins, both Republicans, broke with their party and voted to advance the legislation. Ohio Republican U.S. Sen. JD Vance didn’t vote.

At the precise moment the crawler on the bottom of one of my computer screens flashed the news about the failed vote, I was vetting an informed consent document on the efficacy of administering an injection of a particular drug SubQ (into the fatty tissue just beneath the skin, as opposed to IV -  directly into the vein) for subjects with Multiple Sclerosis - a long-lasting (chronic) disease of the central nervous system which is thought to be an autoimmune disorder . . . a condition in which the body attacks itself by mistake.  The object of the study I was working on was to see if a SubQ injection is as safe and clinically efficacious as the same drug when infused or injected into a vein. 

As my eyes moved over to the screen with the crawler, I was reading through the section dealing with pregnancy; both the inclusionary and exclusionary criteria, and what forms of birth control must be used by women (and men) if they are going to be participants in the study.  (n.b.: there are currently more than 1 million people living with MS in the United States; women are three times more likely than men to be diagnosed with this potentially debilitating condition.)  

Just about any and every Informed Consent Form (ICF) contains a rather lengthy and all-encompassing section dealing with pregnancy.  In most cases, pregnancy (or the ability to get a partner pregnant) is an exclusion . . . unless the potential subject of the trial or study uses one or more forms of birth control.  Then the form will continue with a long list of various acceptable methods of control.

As I was scanning this section, half my brain was thinking about the vote just concluded in the U.S. Senate.  Then it dawned on me: if birth control is (G-d forbid) outlawed, it likely lead to the utter dismantling of most future medical research.  How so? Well, if one cannot prevent pregnancy (except via total abstinence) one cannot participate in most - if not all - clinical trials; and without the ability to conduct ethical, well-monitored medical research, few if any new drugs or treatments will ever see the light of day.  I wonder if any of these “pro-birth” (my preferred term for what has heretofore been called "pro-life”) conservatives and anti-science conspiratorialists have considered this chillingly ironic political sequela (a medical term defined as “A pathological condition resulting from a prior disease, injury, or attack.”)  As much as I would like to give the anti-birth control, anti science crowd the benefit of the doubt - i.e. that they haven’t considered the very serious real-life consequences of their political actions - I cannot; the fact of the matter is that the further they progress, the more medical science - and thus all of us - retrogress. 

Not a day goes by without hearing that in 2024, Democracy, freedom, and the right to choose are all on the ballot.  Those making this breathless statement are telling the truth.  Now we can add another truth: in 2024, the future of both science and medicine are also on the ballot.  Think wisely; be proactive; the future is ours to protect, so that we may all be protected in and from the future. 

Copyright©2024 Kurt Franklin Stone

#933: "A Toad Under the Harrow"

Matthew Kacsmaryk is a Judge of the United States District Court for the Northern District of Texas. He is the jurist (?) who, just the other day issued a ruling in case No. 23-10362, called ALLIANCE FOR HIPPOCRATIC MEDICINE et al v. U.S. FOOD AND DRUG ADMINISTRATION et al, by which he single-handedly fulfilled the hopes, prayers and genuflections of millions of “hyper-moral, liberty-loving Americans” by issuing a nationwide ban on the use of the abortifacient Mifepristone (Mifeprex, a progesterone blocker), one of two drugs (the other being Misoprostol, a hormone originally created to prevent stomach ulcers caused by anti-inflammatories [NSAIDs] which are  commonly used to medically terminate pregnancies. (n.b. The Fifth Circuit Court of Appeals quickly reversed part of Kacsmaryk’s ruling, though the case will likely go before the Supreme Court for full resolution.)

Judge Kacsmaryk’s ruling, to say the least, was and is both bizarre and deeply troublesome. Unquestionably, the most bizarre aspect of his 49-page ruling (much of it a listing of the various plaintiffs and defendants) was his repeated reference to the 150-year old Comstock Act . The Act is an anti-vice law passed in 1873 that prohibits the mailing of “obscene or crime-inciting matter.” Kacsmaryk’s effort to resuscitate this 19th-century relic, indicates that an antiquated law passed during the Reconstruction era, will play a central role in the post-Roe v. Wade apocalyptic landscape of abortion law.    #🟦

As described in a December 2022 memorandum by the Justice Department’s Office of Legal Counsel, the original Comstock Act arose from “the handiwork of Anthony Comstock—‘a prominent anti-vice crusader who believed that anything touching upon sex… was obscene.’”

Comstock—who helped found the New York Society for the Suppression of Vice—championed the initial version of the law which forbade the mailing of any drug, medicine or anything “for the prevention of conception, or for causing an unlawful abortion.” The prohibition on contraception and the word “unlawful” were eventually dropped. In its current form found at 18 U.S.C. 1461 (Mailing obscene or crime-inciting matter), the law prohibits “every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device or substance; and every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use” as well as advertising anything falling within these broad categories.

The most deeply troublesome part of his ruling, of course, is its central assertion: that in giving the legal stamp of approval for the use of Mifepristone in 2000, the FDA got it wrong; that the agency - whom many of the ‘hyper moral’ claim is run and staffed by liberal doctors, scientists and elitists with a pro-abortion agenda - all but ignored the possible bad (or even lethal) side effects (called “adverse events” in medical research jargon) for purposes of getting it on to the market.

In the first 18 years of its legal existence, the FDA reported that 24 women, out of approximately 3.7 million (0.000064%), have died after taking mifepristone for the purpose of medical abortion. However, as the FDA notes, “The adverse events cannot with certainty be causally attributed to Mifepristone because of concurrent use of other drugs, other medical or surgical treatments, coexisting medical conditions, and information gaps about patient health status and clinical management of the patient.”

In other words, Judge Kacsmaryk’s contention vis-à-vis bad side effects is utter stuff and nonsense.

The FDA first approved Mifeprex (mifepristone) in September 2000 for the medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. The FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019. The agency’s approval of this generic reflects its determination that Mifepristone Tablets, 200 mg, are therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation.

By extension, Judge Kacsmaryk’s ruling could be used to call any FDA-approved drug or device into question. What’s to say that next week, some fundamentalist group of physicians, pharmacists or chemists wants to sue the FDA over the approval of contraceptive pills, hormones or medical devices because the pre-marketing research wasn’t as muscular as it should have been? Or that the major COVID vaccines and boosters cause far too many deaths? First they came for the press in order to get the public to distrust anything they said or printed. Next they came for the White House and the Congress until its ratings were in the sewer. Now, if Kacsmaryk and his “patriotic” cronies have their way, trust in the Food and Drug Administration (which, by the way, was never run by Dr. Fauci, as many of them claim) will also fall beneath the sub-basement.

(n.b. Yesterday (4/15/23) Supreme Court Justice Samuel Alito issued an administrative stay of Judge Kascmaryk’s ruling until the end of the day, Wednesday, April 19. The Department of Justice has filed paperwork with SCOTUS, arguing that Kascmaryk’s ruling is legally unsupportable, and thus should be overturned.)

Those of us who labor long and hard in the vineyards of research, clinical trials and medical ethics (which is not an oxymoron), know very well just how long, exhausting and thoroughgoing the process is for getting anything medical, pharmaceutical or technical approved by the FDA. Generally speaking, it takes years, billions of dollars, and innumerable trial phases (starting with laboratory animals, then healthy human subjects,  then  subjects having a particular disease or condition and finally, post-marketing statistics. Anyone participating in trials is fully informed as to what is going to happen if they voluntarily consent to enter a study. Any and all potential adverse events are spelled out; anything in a consent document that is even remotely pushy or fanciful is deleted. Every step along the way is evaluated and overseen by either a Board of Ethics or an Institutional Review Board. This is how I’ve been earning my living for several decades . . .  (And by the way, all consent documents contain a boilerplate comment to the effect that “there may be other potential adverse events that we are not currently aware of.”)

Debunking Judge Kacsmaryk’s contention that not all dangerous side effects were investigated prior to FDA approval of Mifepristone or Misoprostol is actually pretty easy: all one has to do is go to www.clinicaltrials.gov type in which ever drug, device or surgical technique you wish, and you will get a full history of any and every trial ever done. As but one example, if you go to the site and type in Mifepristone, up will pop 227 different trials and studies carried out over the years. You will discover that there are still active studies investigating other uses for this drug . . . including certain types of breast cancer, type2 diabetes and Adenomyosis. Type in Misoprostol and you will find 566 past, present and proposed studies on many, many issues affecting women.

(Please note: deciphering medical terminology can be difficult. If you go on to the clinical trials website, you may need to ask your family doctor, specialist, pharmacist or, in some cases, your rabbi (!) to translate things into understandable English.)

                Judge Matthew Kacsmaryk (1977- )

At about the time Matthew Kacsmaryk was being considered for a lifetime appointment to the federal bench (early 2017) he submitted a draft article to a Texas law review criticizing Obama-era protections for transgender people and those seeking abortions. At the time, he had already spent several years working for a conservative legal group fighting legal fights on behalf those who demanded that their religious beliefs and scruples be protected as a matter of law.

The Obama administration, the draft article argued, had discounted religious physicians who “cannot use their scalpels to make female what God created male” and “cannot use their pens to prescribe or dispense abortifacient drugs designed to kill unborn children.”

But a few months after the piece arrived, an editor at the law journal who had been working with Kacsmaryk received an unusual email: Citing “reasons I may discuss at a later date,” Kacsmaryk, who had originally been listed as the article’s sole author, said he would be removing his name and replacing it with those of two colleagues at his legal group, First Liberty Institute, according to emails and early drafts obtained by The Washington Post. The article, titled “The Jurisprudence of the Body,” argues that religious physicians “cannot use their scalpels to make female what God created male” and “cannot use their pens to prescribe” abortion medication “designed to kill unborn children.”  Kacsmaryk asked for his name to be removed from the article for “reasons I may discuss at a later date” and be replaced by two coworkers at the religious freedom-focused law firm

When Matthew Kacsmaryk appeared before the Senate Judiciary Committee, his dossier and collection of legal essays did not contain any information about “The Jurisprudence of the Body." It had simply disappeared from his record.  In swearing to tell the truth, the whole truth and nothing but the truth, he told the assembled senators that his private religious beliefs would in no way affect his ability to make dispassionate decisions based solely on the law and legal precedents. In other words, like the 3 justices named to the Supreme Court by Donald Trump (Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett), Matthew Kacsmaryk lied; they too proclaimed that they would follow legal precedent when it came to Roe v. Wade.  And of course, all 3 voted in favor of its dismemberment.

I wonder how Judge Kacsmaryk or the current Supreme Court would respond to a lawsuit filed on behalf of plaintiff’s claiming that the drug Sildenafil should never have been approved by the FDA? Using the Texas judge’s legal logic, it should be banned.  This, of course, will never happen; it will never even be considered.  Why? Because Sildenafil is known by 2 generic names: Viagra and Revatio.

The next time we vote, please remember that positions on the federal bench are lifetime appointments. It is far too easy for ideologues like Kacsmaryk or G-d knows how many Trump/McConnell/Federalist Society appointees who urrent occupy seats and gavels which will give them the power to veto the wishes of vast majorities for at least the next generation, if not 2. This should become a major, major issue for the 2024 elections.

As to Judge Kacsmaryk himself, he should be feeling, in the words of the great British novelist and wit P.G. Wodehouse, like “a toad under the harrow” . . . like one soon to be chopped up into little pieces. Although Wodehouse was writing about Hildebrand Spencer Poynt de Burgh, twelfth Earl of Dreever, it could easily have been about Matthew Joseph Kacsmaryk. Writing about the good Earl of Dreever, Wodehouse noted: “Nature had equipped Hildebrand Spencer Poynt de Burgh with one of those cheap-substitute minds. What passed for brain in him was to genuine gray matter as just-as-good imitation coffee is to real Mocha. In moments of emotion and mental stress, consequently, his reasoning . . . was apt to be in a class of its own.”

Copyright©2023 Kurt F. Stone

Riddle Me a Riddle

Stretching across the intellectual highways called “philosophy,” “theology,” and “cerebral gymnastics,” one finds riddles and intellectual imponderables aplenty, the contemplation of which can provide the best - and occasionally most frustrating - forms of mental, moral and ethical gymnastics. Two of my favorites - neither of which I have come even close to solving - are the following:

Question: if G-d is omnipotent, is it possible for Co* (a divine pronoun I invented 40+ years ago meaning “He/She) to create an object so large and heavy that Co cannot lift it?

Answer: Of course not.  If G-d could  create such an object, that would wipe out Co’s omnipotence, because there would be something beyond Co’s physical ability.

Question: But if the omnipotent G-d were incapable of creating such an object, wouldn’t that then mean that there is something beyond that very omnipotence . . . namely the inability to create something too large and heavy to lift? 

Answer: You’ve given me a migraine . . . better check back later . . . much, much later.

Then there’s imponderable #2, which comes from an early rabbinic work known as Pirke Avot . . . a  book of wisdom whose title is roughly translated as The  Ethics of the Fathers.   In Hebrew it goes:                                                                                                                                                                                                                                                                     

                                                               הַכֹּל צָפוּי, וְהָרְשׁוּת נְתוּנָה,

(ha-kohl tza-fuey, v’ha-r’shoot n’tunah) Roughly translated this enigmatic bit of wisdom states “All things are foreseen, but nonetheless there is free will.”

There’s an obvious paradox at work here:   If G-d knows the future and every act we will do for the rest of our lives, do we truly have free will? Do we truly have a choice how we will behave? It is already known, so to speak, that I will sin at a particular time and place. And if so, there is no possible way I can avoid it! I am going to do it! G-d knows it already! There is no humanly possible way for me to alter my predetermined future! And so, isn’t my life merely a meaningless exercise — a futile performance of an already-written and predetermined script?

I have always been intrigued by this sentence (which is ascribed to the great Rabbi Akiba). I really love it, perhaps because it is an enigma to me, spiritual and intriguing. Every once in awhile the sentence pops up in my mind. And for the longest time, I said “Not yet, I still don’t understand its meaning.”

Talk about an imponderable riddle! Talk about yet another migraine!!

Annie asked me a question the other day that brought this omniscience- versus-free-will conundrum to mind. Annie, as many of you know, has taught for years at Broward College in the Ft. Lauderdale area. She teaches English as a Second Language (ESL) to adult immigrants, refugees and asylees. Her students come from places as diverse as Haiti, Cuba and the Caribbean to South and Central America and the Middle East. Many received next to no education prior to their arrival in the U.S.; some were college-educated doctors, accountants and engineers. The latter find it next to impossible to resume their professions; once skilled surgeons become registered nurses; engineers turn to  the building trades and accountants become bookkeepers.

Recently, the college offered a cash incentive ($250.00) for any and all students who agreed to be vaccinated against COVID-19 and another $250.00 for receiving a booster shot. Annie contacted each and every one of her students to make sure they were aware of this program and answer any questions they might have. Of necessity, she asked each student whether or not they had already been vaccinated and/or received a booster injection. Hauntingly, a fair number of her students - including the doctors and other professionals - had not, but refused to give a reason why.

“How’s it possible for a doctor to be against getting a COVID vaccine?” she asked.  Indeed, how is it possible for anyone (save those whose religion refuses medical attention or those with compromised immune systems) to willingly refuse a potentially life-saving vaccine?  Or fight tooth and nail against being compelled to wear a mask . . . or compare any mandate concerning COVID protection to the Nazis forcing Jews to wear a Yellow Star?  Do they have any brains?  Do they really, truly believe all the conspiracy theorists who likely have been vaccinated behind closed doors?  Amazingly, just the other day fringe factions of the right wing erupted in anger after both former POTUS Trump and former FAUX News commentator Bill O’Reilly urged people to get vaccinated and boosted.  Anti-vax conspiracy theorists  such as Alex Jones and Ali Alexander swiftly rebuked Trump over his pro-vaccine stance. Members of QAnon-linked Telegram channels said they felt betrayed after Trump said to get the shot.  Ultra-conservative millennial commentator Candace Owens hit back hard at Trump for telling the truth about vaccines, explaining to her growing legion of fans that he's "too old" to find the "obscure websites" where people do their own research on the vaccines. "People oftentimes forget that, like, how old Trump is," Owens said on an Instagram Live post last Thursday night. "He comes from a generation — I've seen other people that are older have the exact same perspective, like, they came from a time before TV, before internet, before being able to conduct their independent research."

(It should be noted that Trump, who famously had his own reality TV show, never lived in "a time before TV." Then again, he reportedly doesn't use a computer.)

In the Luddite-larded world of antivaxxers, one finds such utterly ludicrous beliefs as: urging - if not mandating - vaccinations, masks and rigorous hand-washing during a time of mutating pandemia is a “human rights” violation; that according to Fox commentator Tucker Carlson (who, after all, knows everything) the nation’s leading expert in infectious diseases, Dr. Anthony Fauci created the Covid virus (and is making a fortune off of it); and that COVID-19 is a plot by big pharma to make a fortune.  And for those who haven’t been paying a lot of attention, one of the loudest anti-Fauci voices in the country is attorney Robert F. Kennedy, Jr., a mainstay in the vaccines-cause autism brigade whose newest book is entitled The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health, which just about says it all. 

Truth to tell, some of those peddling these - and other ridiculous notions have stock holdings in  many  of the companies manufacturing the very vaccines which are  saving tens of millions of lives.  (One of these is loud-mouthed Georgia Representative Marjorie Taylor Greene who, in addition to recently saying on Steve Bannon’s podcast that "vaccine Nazis [are] "ruining our country," holds stock in AstraZeneca, Pfizer, and Johnson & Johnson.)  In fact, according Business Insider’s “Conflicted Congress” project, at least 13 senators and 35 US representatives held shares in Johnson & Johnson, 11 senators and 34 representatives held shares in Pfizer, and two representatives or their spouses held shares of Moderna. 

In their drive to monetize the COVID pandemic, hardcore right-wing conspirators who insist (and will sell you) that Ivermectin, herbal “cures,” tons of vitamin C and Hydroxychloroquine will cure what ails you are - either knowingly or not - are endangering the lives of the very people they need to “Make America Great Again.” According to a recent report on National Public  Radio, "Since May 2021, people living in counties that voted heavily for Donald Trump during the last presidential election have been nearly three times as likely to die from COVID-19 as those who live in areas that went for now-President Biden.”  Recent polling shows that partisanship is now this single strongest identifying predictor of whether someone is vaccinated. Polling also shows that mistrust in official sources of information and exposure to misinformation, about both COVID-19 and the vaccines, runs high among Republicans.  According to Liz Hamel, vice president of public opinion and survey research at the Kaiser Family Foundation, (a nonpartisan health policy think tank), "An unvaccinated person is three times as likely to lean Republican as they are to lean Democrat . . . . If I wanted to guess if somebody was vaccinated or not and I could only know one thing about them, I would probably ask what their party affiliation is." 

It would take a heartless fool to cheer on those Trump acolytes who are killing the future of their movement by potentially killing themselves. But it has gotten to a point where they won’t even listen to their leader, who now tells them that getting vaccinated and boosted is a good thing.

In the words of Puck, perhaps Shakespeare’s most endearing creation: “Lord, what fools these mortals be!”

Sorry to say, but when push comes to shove, I haven’t got an answer to Annie’s question about how in the world doctors and otherwise educated people - let alone those who are not - can bury their heads in the sand and their feet in concrete when it comes to saving their lives and the lives of their families and friends. It will have to remain an unsolvable riddle . . . perhaps even to the G-d who, despite being both omnipotent and omniscient, grants each of us free will . . .

Copyright©2021, Kurt F. Stone   

We Alone Can Fix It

In their riveting, best-seller on the final year of Donald Trump’s presidency (Only I Can Fix It) crack Washington Post writers Carol Leonnig and Philip Rucker have thrown open the doors and windows of an Oval Office and an administration which perpetually put personal gain and political triumph well above the needs, interests and future of the people of the United States, and thus the world. Far from being a partisan political screed, Leonnig’s and Rucker’s book is a day-by-day, moment-by-moment account of what history will likely remember as being the most misguided presidency in this nation’s history - ever since the day George Washington took the oath of office in New York. Speaking of our country’s first President, Trump actually had the delusional chutzpah to claim “I think it would be hard if George Washington came back from the dead, and he chose Abraham Lincoln as his vice president, I think it would have been very hard for them to beat me.”

In their painstakingly-documented work, Leonnig and Rucker dispassionately show Trump’s growing inability to respond to the Covid pandemic, thus separating the nation’s health from his own political needs - most specifically, of wiping up the electoral floor with former Vice President Joseph Biden in the November election 2020. Most of us well remember reading about Trump’s personal encounter with Covid-19; of his brief hospitalization at Walter Reed, and his sudden return to the White House. Upon reading that he had been treated with a pharmaceutical cocktail of Dexamethasone (a steroid commonly used to treat asthma and rheumatoid arthritis), the experimental drug Remdesivir, (a monoclonal antibody cocktail, also called REGN-COV2), Zinc, Vitamin D, famotidine (Pepsid, to treat ulcers), Melatonin (commonly used to treat insomnia) and aspirin, I thought it to be a rather bizarre medical package with many potential side effects. Particularly the first, Dexamethasone, whose known side effects include paranoia, delirium and hallucinations. From this point on (October 2020) Trump seemed to get weirder and weirder . . .

Trump’s political modus operandi was all about down-playing the seriousness of the Covid-19 virus, and proclaiming - against all available medical evidence - that warm weather (or hydroxychloroquine or internally administered bleach) were just what the doctor ordered — precisely which docs he never got around to telling us. Those who remember his presidential press gatherings will no doubt recall the severely pained, looking down at their shoes responses of such MDs as Deborah Birx (the White House Coronavirus Response Coordinator) and Anthony Fauci (the then long, longtime Director of the National Institute of Allergy and Infectious Diseases and today, President Biden’s Chief Medical Advisor).

Then there was the issue of wearing masks, maintaining social distance and keeping public crowds to an absolute minimum. With all these issues, Trump and his closest advisors came out on the wrong - the strictly political - side of the challenge.  As early as October 2020, Trump told his team that he would not wear a mask in public because he thought it would “make me look weak” in the eyes of his supporters.  In one rambling comment, Trump told a reporter: I just don’t want to be doing — I don’t know, somehow sitting in the Oval Office behind that beautiful Resolute Desk, the great Resolute Desk. I think wearing a face mask as I greet presidents, prime ministers, dictators, kings, queens — I don’t know, somehow I don’t see it for myself. I just, I just don’t.”  Truth to tell, there were any number of high-ranking members of the  administration who paid close attention to what the medical folks were advising. But for many, their tight-lipped approval wound up being a one-way ticket back to the private sector.

As time went on, the Trump version of Covid-19, masking and what its true dangers might be, seeped into the very marrow of his political base . . .  including those who were and are most comfortable with conspiracy theories. They decided that if their leader wouldn’t wear a mask, neither would they;  if their local leaders told them that vaccines were more dangerous than the virus itself, they surely would never submit to a vaccination which included electronic tracking devices . . . and on and on.  

Eventually, Trump and his team came up with their version of FDR’s Manhattan Project: they called it Operation Warp Speed; the name was derived from Star Trek’s imaginary USS Enterprise’s ability to travel at a speed faster than light. Trump’s greatest priority was creating a vaccine (a “cure”) by early November 2020 - just before America went to the polls.  Turns out that the British pharmaceutical giant AstraZeneca came through with a vaccine that was highly effective in blocking transmission of the virus first.  Jared Kusher, the president’s son-in-law quickly brokered a $1.2 billion deal to purchase 300 million of the first one billion doses the  company planned to produce. When told this, his father-in-law “sounded deflated” in Leonnig and Rucker’s words.  “I’m going to get killed,” the president said.  “Oh, this is terrible news.  (British P.M.) Boris Johnson is going to  have a field day with this. . . . I don’t want any press on this” Trump told Health and Human Services Secretary Alex Azar (the former CEO of Eli Lilly & Co. “Don’t do any press on this.  Let’s wait.” 

And so they had to wait until January 21, 2021 - the first day of the Biden administration - to make “Operation Warp Speed” completely functional.

As we head into August, 2021, America and the world are entering a new phase in the COVID19 pandemic. In the past month alone, cases of COVID-19 have tripled, and hospitalizations and deaths are rising among unvaccinated people. While the rates are still sharply down from their January highs, officials are concerned by the reversing trendlines and what they consider needless illness and death. Where at the beginning of June the CDC advised that those who were vaccinated were pretty much out of the woods and that schools, businesses and sporting venues could pretty much resume as before, by the end of July President Biden, CDC Director Dr. Rochelle Wilensky and Dr. Anthony Fauci, the president’s chief medical advisor, are urging that due to the Delta mutation and the fact that so many, many Americans are refusing to be vaccinated, we are likely going to see the return of masks, social distancing and a massive campaign to get people immunized.   “Look,” the POTUS said just the other day, “the only pandemic we have is among the unvaccinated.”

Indeed, there are now approximately 90 million Americans who have yet to get shots. Just four states with low vaccination rates made up 40% of new cases last week, and nearly half of them came from Florida alone. Those of us living here in Florida are well aware of how Governor Ron DeSantis (a.k.a. “Donald Trump’s ‘Mini Me’”) has placed economy over health and actually threatened to fine any business, school or cruise line for mandating people to show proof of having been vaccinated against COVID-19. And, it is strictly against the law here in the “Sunshine State” to mandate the wearing of masks.  According to statistics provided by the Kaiser Family Foundation, states, and individual Congressional Districts that voted for Donald Trump in 2020 had a significantly lower percentage of adults receiving COVID19 vaccinations than states and districts that gave their votes to Joe Biden.  Not only does the rate of the vaccinated-versus-unvaccinated show a partisan political divide, so too does educational level (the lower the amount of schooling, the smaller the percentage of those receiving vaccines) and then there’s  urban-versus rural.  

According to Dr. Fauci, the U.S. is in an “unnecessary predicament . . . . We’re going in the wrong direction.”  And just as the number of those entering hospitals is on the rise, so too are conspiracy theories which keep people from seeking prophylactic measures.  Case in point: when the president suggested that healthcare volunteers go “door'-to-door” talking to people about the importance of getting themselves vaccinated, Representative Madison Cawthorn (R.-NC) warned “Now they’re talking about going door-to-door to take vaccines to the people . . . . Then think about what those mechanisms could be used for,” Cawthorn darkly warned. “They could then go door-to-door to take your guns. They could then go door-to-door to take your Bibles.” 

Although I am a firm supporter of the Constitution’s 1st Amendment right to freedom of speech, this is going too far; it is akin  to violating Justice Holmes’ dictum from the 1919 Schenck v. United States case about "falsely shouting fire in a theatre and causing a panic."  Those who spread these kinds of vile lies via the internet, blogs or the so-called “dark net/dark web” should be fined and be held accountable.  Period.  This is playing with people’s lives, and from what I can see or tell, for purely political reasons.

So obviously, Donald Trump’s claim about “Only I Can Fix It” contained a massive dose of what Grandma used to refer to as “canal water.”  I would like to amend this and state  that  when it comes to the current grave challenge, “Only we can fix it.”  And despite the rapid rise in new cases of COVID-19 and the Delta variant; despite the even greater levels of anger, fear and brainlessness which adhere to imbecilic anti-vaxxers,  there are some challenges which we may well be able to fix.  Increasingly over the past few weeks, there are a greater number of people both great and small, beginning to emerge from the anti-vaxxer’s closet.  Republicans like Senate Minority Leader Mitch McConnell, Louisianan Steve Scalise, number two in House Republican leadership  and Alabama Governor Kay Ivey are admitting to having been vaccinated and urging their constituents to do likewise.  Conservative radio and television celebs like talker Phil  Valentine and Fox News’ Sean Hannity are talking up the necessity of being vaccinated.  (Egad . . . for the first time in my life Sean Hannity and I actually agree on something!)

Locally, teachers,  preachers, sports icons and just plain folks are standing up, helping people change their minds . . . coming to the understand that getting a shot and wearing a mask is not  the end of personal freedom . . . but can actually save lives.  I’ve come to believe that where once  these  Republicans used the weapon of fear in order to score  points and win votes, it’s now come too close to home; the time to act like responsible, empathic leaders is now.

I wish I could tell you that having a heart-to-heart conversation with a staunchly anti-vaxx neighbor, friend or family member just might help them change their tune - but I cannot.  Debating people who  choose not to think for themselves is akin to banging one’s head against a brick wall; all you gain is a concussion or a migraine.  And so, unless you are in love with cerebral pain, leave the convincing to those occupying the same original space as the naysayers.

These are difficult times.  However, I do believe that a healthier future is within our grasp - if only we recognize that together, we can fix it. 

Masks on!

Copyright2021 Kurt F. Stone

Like an Exclamation Point in the Heavens

According to an age-old Jewish belief, when a person passes away on Shabbat (the Jewish Sabbath) or a Yom Tov (a major Jewish holiday), it is as if the ribono shel olam (the Master of the Universe) has placed a shimmering exclamation point in the highest heavens for the one who has departed this world. Now, when that major Jewish holiday coincides with the Sabbath itself, that exclamation point - so we are told -not merely shimmers; it is radiates with a light that seems to last an eternity. I have to believe that is why Justice Ruth Bader Ginsburg departed this mortal coil on what we call Shabbat Rosh Hashana - “The Sabbath which falls on the Jewish New Year.”  It permits G-d to express in the most obvious of ways, just how truly exceptional the good justice was, is, and always shall be.  

Without question, Ruth Bader Ginsburg was one of the most stellar and consequential Justices in the history of the Supreme Court of the United States.  A thoroughgoing judicial progressive, she was also a great friend of the court’s most intellectually stolid conservative, the late Antonin Scalia.  What in the world could the two have in common? Opera.  That’s the way things used to be in politics and the judiciary; human beings getting along with one another because they discovered the humanity in one another . . . regardless of their disagreements.  Justices Ginsburg and Scalia also shared a love of the law despite viewing it from bipolar angles. 

(BTW: for those who might want to learn a  lot more about Ruth Bader Ginsburg the woman, I highly recommend the best book I have ever read about the Jewish Justices of the Supreme Court: my good friend, constant lunch companion and fellow Californian David Dalin’s magnificent work, Jewish Justices of the Supreme Court From Brandeis to Kagan.  It’s a great read!).

Yesterday (September 21) it was announced that Justice Ginsburg will lie in state in the United States Capitol. It is an unusual honor for a Supreme Court Justice and one that has never before been granted to a woman. Had the decision been in the hands of ‘45, there is every reason to assume that this honor would never have been afforded America’s more revered and beloved legal lioness. But precisely who receives the honor of lying in state in the Capitol is a decision that rests squarely with the Speaker - in this case, Nancy Pelosi who was a longtime friend and admirer of Justice Ginsburg. In describing RBG’s death, Madam Speaker called it “an incalculable loss for our democracy and for all who sacrifice and strive to build a better future for our children.” Also out of the ordinary, Justice Ginsburg will lie in repose at the Supreme Court for two days - tomorrow and Thursday, and her coffin will be placed under the portico at the top of the building’s front steps. Her coffin will be placed on the Lincoln catafalque, which was used for President Abraham Lincoln’s coffin when his body lay in state in the Capitol Rotunda in 1865.

Such respect has rarely been shown for a Supreme Court justice. But then again, we’ve rarely been in the historic presence of such a diminutive giant . . .

Then too, RBG’s death - like just about everything these days - has already become the focus of a nasty political war of words and deeds. No sooner had justice Ginsburg’s passing been announced then partisan politics reared its terribly ugly head.  Within 2 hours, Georgia Republican Representative Doug Collins tweeted “RIP to the more than 30 million innocent babies that have been murdered during the decades that Ruth Bader Ginsburg defended pro-abortion laws. With @realDonaldTrump nominating a replacement that values human life, generations of unborn children have a chance to live,” Collins wrote.  (It should be noted that Ruth Bader Ginsburg didn’t take her seat on the nation’s highest court until Roe v Wade had been the law for nearly a generation and that for nearly more than 25 years, Donald Trump was one of NYC’s larger donors to Planned Parenthood.) Getting back to Rep. Collins, even Fox News nailed him for his extra nasty tweet.  Many conservative Republicans were terribly concerned lest the next Justice not be 100% in favor of overturning Rose V. Wade, putting the 2nd Amendment in jeopardy, or permitting the President of the United States from using his office to do whatsoever he sought fit to do.  And mind you, all this was made public hours and hours before Justice Ginsburg was laid to rest. 

Those who have long followed politics closely will well recall all the sturm und drang (turmoil) that arose in Mitch McConnell’s senate when then-POTUS Obama nominated Federal Judge Merrick Garland to the High Court more than 8 months before the 2016 presidential election. (Garland, then - and now - was a United States Circuit Judge of the United States Court of Appeals for the District of Columbia Circuit. whom Obama had nominated to replace the late Justice Antonin Scalia. Back in 2016, you will recall, McConnell and virtually all his Republican colleagues refused to even consider the nomination of the progressive Judge Garland claimed that “voters should be given a say by way of choosing the next president. A sprinkling of quotes from 2016 will reveal how Leader McConnell and his Republican colleagues responded to the question “Should the Senate vote hold hearings or a vote on Judge Garland?

• Marco Rubio (FL): “I don’t think we should be moving forward on a nominee in the last year of this president’s term. I would say that if this was a Republican president.” (3/17/16)

• Chuck Grassley ( IA): “A lifetime appointment that could dramatically impact individual freedoms and change the direction of the court for at least a generation is too important to get bogged down in politics. The American people should not be denied a voice. Do we want a court that interprets the law, or do we want a court that acts as an unelected super-legislature . . .?” (3/16/16)

• Mitch McConnell (KY) “The American people should have a voice in the selection of their next Supreme Court Justice. Therefore, this vacancy should not be filled until we have a new president..” (2/13/16)

• John Hoeven (ND): ““There is 80 years of precedent for not nominating and confirming a new justice of the Supreme Court in the final year of a president’s term so that people can have a say in this  very important decision.” (4/21/16)

• Lindsay Graham (SC): “I strongly support giving the American people a voice in choosing the next Supreme Court nominee by electing a new president.  I hope all Americans understand how important their vote is when itcomes  to picking a new Supreme Court justice. (3/16/16)  

• John Cornyn (TX): “At this critical juncture in our nation’s history, Texans and the American people deserve to have a say in the selection of the next lifetime appointment to the  Supreme Court. The only way  to empower the American people and ensure they have a voice is for the next president to make the nomination to fill this vacancy.” (3/16/16)

• Ted Cruz (TX) “This should be a decision for  the people.  Let the election decide.  If the Democrats want to replace this nominee, they need to win the election.” (2/14/16)

As of this morning, there are only 2 Republican members of the U.S. Senate - Alaska’s Lisa Murkowski and Maine’s Susan Collins - have announced that they urge waiting until after the 2020 election before taking up the matter of Justice Ginsburg’s replacement.  It seems clear that all those Republicans who kept Judge Garland from even getting a hearing because of some “Constitutional principle,” have now shown their true colors  . . . bright yellow.  And this, despite a report from NPR’s longtime legal affairs correspondent Nina Totenberg that Justice Ginsburg’s dying wish (made bedside surrounded by family members and her personal physician) was that  she wanted the winner of the November election to choose her replacement.  The POTUS and members of the Fox entertainment squad rushed to declare - without a scintilla of proof - that the dying Justice never made this final request.  Instead, ‘45 suggested (again, without evidence) that the dying wish was likely crafted by either Adam Schiff, Chuck Schumer and/or Nancy Pelosi. Fox entertainer Tucker Carlson said flatly that he doesn’t believe Ginsburg actually dictated the message: “We don’t know actually what Ruth Bader Ginsburg’s final words were. Did she really leave this world fretting about a presidential election? We don’t believe it for a second.”  Rep. Schiff (whom ‘45 referred to as “Shifty” Schiff in his Tweet denying Ginsburg’s dying wish (which her granddaughter wrote down) issued his own tweet denying ‘45’s claim: “Mr. President, this is low.  Even for you.  No, I didn’t write Ruth Bader Ginsburg’s dying wish to a nation she served so well, and spent her  whole life making a more perfect union.  But I am going to fight like hell to make it come true.  No confirmation before inauguration.” 

Justice Ginsburg’s longtime friend, correspondent Totenberg said yesterday that she confirmed the dying wish with the Justice’s doctor.  Despite this, Trump and Carlson’s false claim spawned numerous conspiracy theories on social media, claiming that Ginsburg dictated the note to her “8-year old granddaughter.” (Far from being an 8 year old, Clara Spera  [who always called her grandmother bubbie attended Cambridge, graduated from Harvard Law in 2017, and is married to Shakespearean actor Rory Boyd.)  All this, and Justice Ginsburg has yet to be laid to rest. . .

It is highly likely that Trump and the Republicans will get  their way and make sure that SCOTUS finally becomes an impregnable bastion of Federalist Society judges; one easily capable of overturning Roe v Wade, of kicking the vast majority of people with preexisting medical conditions (which now includes COVID-19) off of Obamacare; of finding the constitutional “Emoluments Clause” unconstitutional; of outlawing the teaching of Darwinian theory in public schools and of giving the National Rifle Association whatever in the world it wants.

So what can be done?  To my way of thinking it is imperative that  Democrats recapture both the White House and United States Senate, expand Democratic victories to state legislatures and governors’ mansions, and give serious, serious consideration to instituting their own version of FDR’s “court packing plan.” There is nothing in the Constitution which states that SCOTUS must have precisely 9 members.  

And above all, let’s keep the spirit and strength of Justice Ruth Bader Ginsburg alive.  Just look up to the heavens, look for that celestial exclamation point and let her fortitude be our fuel.

42 days until the election . . .

Copyright©2020 Kurt F. Stone

The Gift That Keeps on Giving

The Gift That Keeps on Giving

Wasn’t it Albert Einstein who defined insanity as "doing the same thing over and over again and expecting different results”? Maybe yes and maybe know. Over the years I’ve read articles claiming that it was Benjamin Franklin . . . or Mark Twain . . . or writer Rita Mae Brown in her 1984 novel Sudden Death who was the creator of record. Regardless of who birthed the truism one must admit that it is both clever and spot-on. Seeing as major league baseball is back in season (Hallelujah!) we can give the following example of Einstein’s “razor”: the general manager of a team which came in dead last in the previous 3 seasons opens the next season with precisely the same roster yet expects to make it to the World Series. This is, of course, utter insanity.

Another prime example - this from the world of politics - would be ‘45’s decision to launch yet another full-scale assault on the Affordable Care Act (aka “Obamacare”) the day after declaring himself totally exonerated by the Mueller investigation. (n.b. until the full report is turned over to Congress and the public, ‘45 is jumping the gun; A.G. Barr’s 4 page Cliff Notes version of the Special Counsel’s 400+ page report obviously doesn’t say much of anything. It’s akin to summarizing Dostoevsky’s massive Crime and Punishment in a single sentence: A super broke college dropout becomes convinced that the universe is telling him to kill a pawnbroker because that’s what great men do — which he does, but eventually confesses to at the urging of an extremely Christian prostitute.)

‘45’s renewed interest in healthcare comes on the heels of his administration’s announcement this past week that it supported a conservative judge’s December ruling to wipe out Obamacare completely, based on a technicality involving the individual mandate, which Sir Donald of Orange already has eliminated. “If the Supreme Court rules that Obamacare is out, we will have a plan that is far better than Obamacare,” POTUS said Wednesday, a day after declaring that “the Republican Party will soon be known as the party of healthcare.” Why in the world he has once again returned the total dismemberment of Obamacare to center stage (without having the faintest idea what he’s going to replace it with) is anyone’s guess. Several possible answers come to mind:

• Perhaps it’s because the man is utterly obsessed with uprooting and destroying every vestige of his predecessor’s record.

• Perhaps it’s because he is nuttier than a fruitcake or that when it comes to retail politics, the man is stunningly tone deaf.

• Perhaps he is catering to his base - the only folks left in American society who can feed his ego . . . the men, women and children wearing those red “MAGA” hats and endlessly shouting out “LOCK HER/HIM/THEM UP!!” If this is the case, it would mean that in his self-deluded state he believes that so long as he can hold on to their votes, he can easily be reelected.

• Perhaps he’s once again proving to himself and the world what he claimed on January 23, 2016: "I could stand in the middle of Fifth Avenue and shoot somebody and wouldn’t lose any voters, OK? It’s, like, incredible.”

• Perhaps by reviving the “Obamacare is evil and therefore must go” meme, he is revealing a central focus of his 2020 campaign: that all Democrats are Socialists intent on nothing less than the total destruction of America.

What ‘45 and his cabal don’t seem to understand is that a majority of the American public supports the ACA, especially provisions which debar health insurance companies from charging higher rates to those with preexisting conditions and permits younger Americans to continue being covered by their parents’ healthcare plans until age 26. Nor do they seem to grasp that the single-most important issue which caused them to lose the House this past November was healthcare. Why the president, his advisers and Department of Justice would once again pick a fight they just lost is beyond reason. So far, leading Republicans on Capitol Hill have shown little desire to make themselves into - in the president’s words - “The party of healthcare.”

“We’re coming up with plans,” Trump said ambiguously this past Wednesday, just as he’s been saying for years. Yet neither he nor any other Republican has come up with a viable healthcare plan that would cover as many people as Obamacare or offer people as much protection. That’s not fake news. That’s just a fact. And here’s another fact: if Obamacare goes, at least 20 million Americans will once again be without health insurance. Out of necessity, they will have to go to emergency rooms to receive care . . . and this is the most costly form of healthcare ever devised.

POTUS has appointed and anointed 3 senators (John Barrasso (R-WY), Bill Cassidy (R-LA), and Rick Scott (R-FL)—to come up with a plan. (It should be noted that former FL governor Scott refused to permit a single federal dollar to enter his state to help expand Medicaid and, as the one-time CEO of Columbia/HCA, the hospital company was fined $1.7 billion for Medicare fraud.) One wonders what sort of proposal they’re going to come up with. For many Republican congressional leaders, they’ve urged the White House to come up with their own proposal . . . and not rely upon the Republican-led senate. In other words, GOP legislators are scared to death about having to defend “Trumpcare” in 2020.

Living as we do in a world and a time where political conspiracies are as commonplace as a beer at a ballgame, permit me to spin one myself. What if ‘45’s mega-wealthy “friends” and supporters have simply become fed up with him and convinced him that destroying Obamacare from stem to stern (or from brain to big toe) is the best way of assuring overwhelming victory in 2020. They know how stupid he is; they understand both his naivete and his narcissism; they cannot afford to be identified with him . . . he is simply not one of them. So what to do? Convince him to take over leadership of a cause which stands the best chance of putting him out of their misery.

There is some evidence to support the theory of billionaires turning their backs on ‘45 so that he won’t be reelected. Already this year, we’ve seen the Koch brothers - Charles & David - publicly announce that they will neither support nor spend a single dime on ‘45’s reelection. Instead, they will be putting their time, energy and vast financial resources (and those of their contributing network) behind those who advocate for establishing permanent legal status for “Dreamers” (undocumented immigrants brought to the U.S. as children), as well as on gubernatorial and congressional races, prioritizing issues including poverty and drug addiction. 

And so, at least on the political surface - and for whatever reason - the president has given the Democrats a remarkable gift . . . just so long as they remain reasonably unified, coalesce around a candidate who can win, and keep their eyes on the prize. Even with this remarkable “gift that keeps on giving,” the Democrats do have a historic tendency to shoot themselves in the foot.

Stand tall, act wisely and please, please . . . remember how much is at stake. A gift box left unopened is a more than sad. Several gift boxes left unopened is . . . in the words of Einstein, (or Franklin or Twain or Rita Mae Brown) insanity.

583 days until the next election.

Copyright©2019 Kurt F. Stone

"The One Who Saves a Single Life . . . "

                              Drs.  Vibhav and Sonal Rangarajan and Their daughter, Radha

A couple of days ago, Attorney General Jeff Sessions stood before a gathering in Ft. Wayne, Indiana, and quoted the Christian Bible (Romans 13) as justification for the Administration's "Zero Tolerance" policy on illegal immigration. This is the policy which forcibly separates children from their parents if they cross the Southern border illegally.  According to Sessions, it is a lawful deterrent and is actually backed by the Bible.  “I would cite you to the Apostle Paul and his clear and wise command in Romans 13, to obey the laws of the government because God has ordained them for the purpose of order,” When asked to comment on Sessions' use of the Bible to justify the government's separating children from their parents, White House Press Secretary Sarah Huckabee Sanders doubled down saying it is "very biblical to enforce the law."  Of course, quoting standalone Biblical verses (from either the Hebrew or Christian version) to justify immoral actions on the part of the government is far from new: whenever Congress debates cuts in the food stamp program (SNAP - "Supplemental Nutritional Assistance Program") some damn fool will quote 2 Thessalonians 3:10: “The one who is unwilling to work shall not eat.”

As one who has spent the better part of a life studying (as opposed to "reading") both the Hebrew and Christian Bible in their original languages, I can, if called on, cite tons of verses from James, Matthew, Isaiah and Proverbs (to name but a few) which command us to "feed the hungry, clothe the naked visit the sick and take in and give shelter to the stranger."

This current crappola about citing Holy Writ to justify separating children from their parents brings to mind Antonio's admonition to Bassanio in Shakespeare's The Merchant of Venice (Act I, Scene 3, Page 5): 

Mark you this, Bassanio, the devil can cite Scripture for his purpose.
An evil soul producing holy witness Is like a villain with a smiling cheek,
A goodly apple rotten at the heart.

Having gone this far I must tell you that although I am about to quote an ancient religious text (not the Bible), this week's essay - although it does involve a child - has nothing to do with immigration and little to do with the federal government.  The passage comes from the 2nd century (C.E.) work Mishnah Sanhedrin 4:5

שֶׁכָּל הַמְאַבֵּד נֶפֶשׁ אַחַת מִיִּשְׂרָאֵל, מַעֲלֶה עָלָיו הַכָּתוּב כְּאִלּוּ אִבֵּד עוֹלָם מָלֵא. וְכָל הַמְקַיֵּם נֶפֶשׁ אַחַת מִיִּשְׂרָאֵל, מַעֲלֶה עָלָיו הַכָּתוּב כְּאִלּוּ קִיֵּם עוֹלָם מָלֵא   

Namely: "Anyone who destroys a life is considered by Scripture to have destroyed an entire world; and anyone who saves a life is as if he saved an entire world."

So what's this week's essay about?  Where am I going?  Well, yesterday, there appeared in my inbox an email from Vibhav Rangarajan, M.D., a practicing cardiologist/internist in Chicago.  Dr. Rangarajan graduated from Tufts University School of Medicine in 2010, and served his residency in Cardiology at the University of Illinois/Chicago. He is currently an instructor at the Feinberg School of Medicine at Northwestern, as well as being in private practice. He has been married since 2013 to Dr. Sonal Patel Rangarajan who specializes in pediatric gastroenterology.  They have a two-year old daughter named Radha, who was recently diagnosed with a "lysosomal storage disorder" . . . there are about 50 of these rare metabolic disorders.  The specific one that Radha has is called Metachromatic Leukodystrophy  (called by many names including "Greenfield Disease" and "MLD").  In his most heartfelt email, Dr. Vidhav admitted to having "memorized a few details about these rare diseases (lysosomal storage disorders) in preparation for my board exam, and then never gave them another thought." Why?  Because they are pediatric and he was going to be a cardiologist. Since Radha's diagnosis - which is bleak - he and Dr. Sonal have learned far, far more than they ever knew before.  

Without getting too technical, MLD is a genetic disease which interferes with the body's production of a single enzyme (protein).  Without enough of this particular enzyme - which ultimately insulates and protects nerves - all hell can break loose; it can destroy tissue throughout the brain, spinal cord, and other parts of the nervous system.  Quality of life - not to mention life expectancy - for a child with MLD is both bitter and brief.  As readers of The K.F. Stone Weekly know, I am not an M.D. - far, far from it.  However, I have been privileged to work with a team of world-class physicians, pharmocolgists, pathologists and diagnosticians for nearly a quarter century on an institutional review board, whose task it is to review, vet and make understandable, virtually every type of medical research protocol on the horizon. Our company holds a minimum of ten meetings a week via teleconference.  Over the years, I have attended hundreds and hundreds of these meetings and reviewed easily more than a thousand research protocols.  My main role is translating medical terminology into lay language. Sometimes, we review what are called "Compassionate Use Requests," which involve getting not-yet-FDA-approved and grossly expensive drugs to subjects who suffer from rare (sometimes called "Orphan") diseases and conditions.  We don't put the pressure on a particular company or drug manufacturer to grant the compassionate use status; rather, it is they who generally come to us, for it is our overarching task to insure the safety of the subject(s) who will be taking the drug.  

Regrettably, there are all sorts of diseases and conditions which do not have drugs, therapies or surgical procedures that are yet ready to be used.  It turns out, there is a drug being tested and developed for many lysosomal storage disorders, including Metachromatic Leukodystrophy by Shire Pharmaceuticals - a biotech firm which specializes in rare diseases.  At this point, Shire has even completed a multicenter Phase 1/2 trial of the drug (new drug trials generally go through phases 3 and even 4).  The drug is called SHP-611 (also known as HGT-1110) in Europe; it appears to be showing some promising results. But, for whatever reason, they have turned down the Rangarajan's request to grant Radha compassionate use status.  Why is anyone's guess, but it stinks to holy hell.  Her parents are doing everything in their power to draw attention to their daughter's plight; left untreated, this precious little girl could be in a vegetative state before too long, and likely won't ever see the age of 8. The FDA (Federal Drug Administration) cannot compel a company like Shire to provide Radha (even if her parents were able to pay) with SHP-611/HGT-1110. Recently, the president signed into law a controversial piece of legislation called the "Right to Try" law which, at least in theory, would offer terminally ill patients expanded access to unapproved treatments.  Despite crowing about how many lives will be saved by means of this legislation ("We will be saving — I don’t even want to say thousands because I think it’s going to be much more — thousands and thousands, hundreds of thousands, we’re going to be saving tremendous numbers of lives. There were no options, and now you have hope.”) the bill's true purpose is to undermine the FDA by eliminating many of the regulations they impose and oversee - regulations which ultimately protect test subjects and ultimately, patients.  Why?  Perhaps because eliminating regulations will make bringing new drugs, devices or procedures to market will be a whole lot less expensive.

When I read Dr. Vibhav's email, I was touched to the core.  Knowing that many of you - my beloved readers - are people of quality and compassion - I have decided to issue a plea . . . that you and your friends sign a petition to Shire, urging them in the strongest possible terms to grant compassionate status to Radha.  As of a few minutes ago (8:35 PM (EST) June 17, 2018 - nearly 180,000 people have signed the Rangarajan's petition to Shire.  I urge you to add your name (and perhaps a couple of dollars) to the cause. 

Do remember that ancient truth expressed in the Mishnah: "Anyone who saves a single life, it is as if that person had saved the entire world."  In his time of gross insensitivity, where each day brings hideousheadlines about man's inhumanity to manwhere every day brings yet another hideous headline; so many of us are frustrated, freaked out and feeling oh so powerless against the forces of narcissistic self-centeredness.  Well, I'm here to tell you that we do have power; we actually can make a difference, if only we find our communal voice and make our humaneness known. I urge you and your friends to  speak up on behalf of Radha; put her plight on your Facebook page; send Dr. Rangarajan's email to everyone on your list. Save Radha's life . . . save the universe.

From what I've recently learned, in Sanskrit, "Radha" (राधा) means 'success' or 'prosperity.' Together we can, G-d willing, give her the chance to live up to her name and succeed at life, while prospering in terms of health. Then too, by doing what we can for her and her family, we too can succeed and prosper.

Find you voice!

516 days down, 957 days to go.

Copyright©2018 Kurt F. Stone

The Right to Try: Is It a Lie?

Last Tuesday (March 13, 2018) in a gutsy, contentious vote, the Republican-controlled House failed to pass a "right-to-try" bill (H.R. 5247) that would have given terminally ill patients access to experimental drugs and medical devices without FDA authorization. The final 259-140 vote, which fell short of the necessary two-thirds support from the House chamber, represented a setback for the president, who called on Congress to approve the bill in his State of the Union address six weeks ago . . . as well as a small libertarian think tank (the Goldwater Institute)  which has been the driving force behind the effort.  The bill - which got to the House floor without having gone through a single committee hearing - would permit patients suffering from terminal illnesses, upon a request from their physician to a specific pharmaceutical company or medical device manufacturer, to get access to a non-approved medication or device available without having to go to or through the FDA.  While at first glance the legislation would appear to be a compassionate no-brainer, this "right-to-try" legislation (RTT) is, in reality, a lie whose main beneficiaries are not terminally-ill men, women and children.

In his first State of the Union address, the only piece of legislation 45 specifically mentioned was this "right-to-try" bill, which had, in a slightly different form, unanimously passed the Senate.  In the president's address, he said: "We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the 'right to try.'"  On the surface, right-to-try legislation seems like a no-brainer;  after all, who but a heartless ghoul would deny terminally ill patients access to potentially life-saving drugs, treatments or devices?  That's on the surface. However, descend a few steps beneath that surface and a plethora of problems begin to emerge.  

First and foremost is the matter of safety.  The  proposed federal law would only require the successful completion of a Phase I study, which isn’t enough to ensure efficacy or safety on its own. (Phase I studies, which enlist healthy subjects, are primarily interested in determining what - if any - adverse events [bad side effects] a drug may have; what the maximum tolerated dose [MTD] might be, and how the body absorbs, metabolizes and excretes the drug [PK].  What a phase I study does not look for is whether or not the drug, device or procedure is beneficial - i.e. capable of having a curative effect. In order to find out if a drug or device works requires additional phases using subjects who actually have the disease or malady.  The "gold standard" for a phase II or III study is called "Double-blind, placebo-controlled," in which neither the doctor nor the subject knows whether they are receiving the study drug or a dummy "sugar pill." All these phases (which can also include phase IV and post-marketing) take years and tens - sometimes hundreds - of millions of dollars to complete. But underlying all the research is the ethical mandate "First, do no harm."  Contrary to our unfounded optimism about medical progress which insists that new drugs must be good drugs, fewer than 10 percent of drugs that enter Phase I end up being approved; for oncology, that figure falls to 5.1 percent.  In other words, "right-to-try" drugs, far from having passed scientific or medical muster, can be unproved and worthless at best, lethal at worst. 

In clinical trials, participants (and/or their insurance carrier) are only charged for "standard-of-care" procedures.  The sponsor pays for everything else . . . especially the medication.  Under terms of the "informed consent" (which all test subjects read and sign before entering a test phase), if the medicine(s) or procedures cause any harm, the sponsor is financially responsible and the participant does not lose any of their legal rights.  Under terms of federal right-to-try legislation, the patient (or their insurance carrier) is on the hook for payment - which can be in the hundreds of thousands of dollars - and cannot sue.  Then too, the very act of using right-to-try therapies can render terminally-ill patients ineligible for health insurance or hospice care when they need it most. Of the right-to-try laws (now on the books in 38 states), half allow insurers to deny patients hospice coverage should they require it after the use of right-to-try drugs. Several have made it clear that health insurers are not obligated to cover the costs of any complications that may arise.  In Colorado, patients undergoing experimental treatment secured under terms of right-try legislation are denied coverage even six months after the treatment has ended.

Unbeknownst to many, the Food and Drug Administration (FDA) has long had an "Expanded Access Program," under terms of which a terminally ill patient’s treating physician, after first having determined that their patient ". . . has a serious or life-threatening condition and no comparable or satisfactory alternative therapy" . . .  then approaches the pharmaceutical company to ask for its agreement that it will provide the drug being sought.  The company has the right to approve or disapprove the physician’s request."  If the company agrees to the physician’s request, the physician can then apply to the FDA for permission to proceed.  Should they do so, they are highly likely to be allowed to proceed. (Between 2010 and 2015, the FDA approved fully 99% of these requests.)  Opponents of this process (starting with the Goldwater Institute) claim that a terminally ill patient could be dead long before the paperwork has been completed.  This is simply not true. Today, the FDA Expanded Access form takes 45 minutes to complete, and the FDA will reply to emergency requests within no more than 24 hours.

So once again, on the surface, federal "right-to-try" legislation seems to be as simple, logical and compassionate as anything under the sun. To libertarians, it is simply a matter of the government keeping the hell away from the individual's right to choose for themselves (except, of course, if that individual is a pregnant female). Who but a political Simon Legree could deny dying patients the right to try unproven medications . . .  even if it turns out to be a "hail Mary pass?"

Who indeed?  Days before the failing House vote (in which 2 Republicans crossed over and voted nay, and 24 Democrats yay), more than 75 patient groups, including the American Cancer Society Cancer Action Network, the American Lung Association and the Cystic Fibrosis Association, had sent a letter to House leaders saying the bill “would not increase access to promising therapies” because it didn't deal with the main barriers to experimental drugs  — the cost of drugs and company restrictions on making therapies available outside of clinical trials.  And by skirting the FDA, the letter added, the proposed right-to-try pathway would be “less safe” for patients than the agency's existing program (expanded access), for overseeing the use of unapproved therapies outside of trials.  Reading between the lines, the goal of federal "right-to-try" legislation is not to make experimental drugs available to desperate patients. The goal is to weaken FDA oversight of the drug approval process.  Weakening FDA oversight can easily open the gates, admitting a parade of medical charlatans to come storming through, preying on the already desperate, dangling "miracle cures" which may well contain nothing more miraculous than hot air and hollow promises.

423 days down, 1,036 days to go . . .

Copyright©2018 Kurt F. Stone

Channeling William Congreve

                  Wm. Congreve (1670-1729)

Between the ages of 23 and 30, William Congreve (1670-1729) was England's most celebrated playwright.  A writer who all but single-handedly created the English "comedy of manners," Congreve was known for " . . . his brilliant comic dialogue, his satirical portrayal of the war of the sexes, and his ironic scrutiny of the affectations of his age."  His major works - all completed by age 30, included The Old Batchelour (1693), The Mourning Bride (1697) and his last - and most frequently staged piece, The Way of the World (1700). A classmate and lifelong friend of the wonderful satirist Jonathan Swift, devoted disciple of England's first Poet Laureate John Dryden and, along with Philosopher John Locke a member in good standing of the Whiggish Kit-Kat Club, Congreve spent the second half of his life living off royalties before succumbing to the grave effects of a carriage accident at age 59.

Many of you reading this essay are familiar with Congreve's most famous bon mots . . . even if you're unfamiliar with the man himself, or any of the plays he wrote.  For if nothing else, the man was quote-worthy.  Two of his best-known phrases come from a play called The Mourning Bride (1697):

• Musick has charms to soothe a savage breast (frequently misquoted as "Music hath charms to sooth the savage beast") and 
• Heaven has no rage like love to hatred turned, Nor hell a fury like a woman scorned, (generally rendered as "Hell hath no fury like a woman scorned).

Trust me when I tell you that this week's essay is neither about William Congreve, Restoration Comedy nor Whig political gatherings in 18th century England.  It's about "Graham-Cassidy," the Republican-controlled Congress's last-ditch effort to finally fulfill its 7+ year promise to "repeal and replace" the Affordable Care Act, aka Obamacare.  During the latter years of the Obama presidency, Republicans voted more than 60 times to repeal the ACA, fully believing that doing so wouldn't involve even a speck of political downside . . . and for several reasons.  First and foremost, they knew that should any repeal measure actually pass, the POTUS would veto it. Second, continually pushing ACA repeal scored points with their rabid anti-anything-Obama base.  And third, they knew there was little political harm in ticking off Democrats, because they weren't likely to vote Republican under the best of circumstances.

I've got to believe that some of the more thoughtful Republicans worried that someday they would actually have to put up a real replacement package - one which would not only pass both houses of a GOP-run Congress and be signed into law by a GOP president, but one which would have a snowball's chance of pleasing someone - anyone - outside their financial backers and faithful flat-earth birther Luddites. When that long prayed-for day finally arrived on January 20, 2017, Republicans began to realize - as said by the new POTUS a  mere five weeks  after his inauguration "Nobody knew healthcare could be so complicated."  Really?  Hadn't you been paying attention to all the weeks and months, all the legislative hearings and the incredible hoops the Dems. had to jump through in order to get party-line passage of the ACA?  Where were you?  Out on the hustings claiming that the entire process from day one to day last was done in secret without so much as a single opportunity for debate.

This of course  is simply not true.  Although the final ACA bill was, to a great extent, masterminded by then Senate Majority Leader Harry Reid (D-NV), this only came about after 79 separate hearings, a ton of amendments and hour upon hour of open public debate.  Compare this to Graham-Cassidy, which has had virtually no hearings, less debate than a gathering of Trappist monks (who take a vow of silence), and virtually no reaching out to their colleagues across the aisle.  

While it is true that the final version of the Affordable Care Act came to slightly over 2,300 pages where Graham-Cassidy is less than 50, it would appear that neither its cosponsors nor the POTUS know precisely what its mandates mean, how much it would cost . . . or even what it says.  As but two examples of this phenomenon: In a September 20, 2017 interview on CNN's "New Day," Senator Cassidy (who in private life is an MD) said that under terms of his bill “We protect those with preexisting conditions. … The protection is absolutely the same [as under Obamacare]. There’s a specific provision that says that if a state applies for a waiver, it must ensure that those with preexisting conditions have affordable and adequate coverage.”  At best. the senator's statement is highly misleading; at worst, it is utterly untrue.  Then there is 45's recent (9-20-17) Tweet in which he wrote: "I would not sign Graham-Cassidy if it did not include coverage of pre-existing conditions. It does! A great Bill. Repeal & Replace."  Late-night talk show host Jimmy Kimmel had the last word on 45's Tweet, saying "Can you imagine Donald Trump actually sitting down to read a health-care bill? It’s like trying to imagine a dog doing your taxes. It just doesn’t compute, you know?” 

The two things all Republicans know for a certainty are that Graham-Cassidy is not Obamacare, and that it would take most of the tax money accrued under the ACA and turn it into block grants for the 50 states . . . essentially permitting each state to figure out how they wish to spend their healthcare dollars. There are, of course, many problems with the "block grant" approach, the most obvious and overwhelming of which being that not all states are equal.  How so? Well, to begin with,  median household income is much higher in New Hampshire than in Arkansas; heart disease and obesity are much bigger problems in Mississippi than in Colorado; the opioid epidemic is much worse in West Virginia than in Nebraska. Relatively sparsely populated areas struggle with the closings of rural hospitals, leaving large geographic areas underserved, while urban areas have a high concentration of large hospitals, many of which struggle with overcrowding. With regard to the first certainty - that Graham Cassidy is not Obamacare, its repeal would represent one more move to remove anything having to do with Barack Obama from the public record. In this it is reminiscent of the Biblical injunction (Exodus 17:45, and Deuteronomy 25:19 concerning Amalek: "Thou shalt blot out the remembrance of Amalek from under heaven; thou shalt not forget it (i.e., to blot out the name and remembrance).

The list of public officials (including Republican governors, mayors and state legislators) national medical associations (now above 75) and "just plain Americans" who are on record as strenuously opposing Graham Cassidy is growing by the minute.  And ironically, the number of Americans who are voicing support for Universal Healthcare is also growing.  Ever since Arizona Senator John McCain came out and stated for the record that he will vote against it (despite his closest friend, Senator Lindsay Graham being one of Trumpcare's eponymous sponsors), there is a pretty good chance the bill will crash and burn.  About the only ones who are totally upset about this possibility are the Republican Party's biggest financial backers . . . people like the brothers Koch who, like their fellow multi-billionaires, stand to lose out on one hell of a lot of cash (via tax breaks) if Graham-Cassidy fails.

The game is in the ninth; the home team is down by a run with the bases loaded, two outs and their best hitter coming to the plate.  Indeed, there is a good reason to keep open a hope for victory.  But hoping isn't the same as action. Get up from your seat, call, text or email your senator; make your voice heard. These men and women do pay attention to what their constituents have to say; especially if they are up for reelection. (By the way, if you do not know your senators' phone numbers follow this link. For those who prefer to communicate their thoughts and feelings via email, follow this link.)

We conclude with yet another quote from William Congreve. In  Act 5, Scene 8 of his first play, the above referenced The Old Bachelour the bachelour's best friend, a chap named Sharper, gives his mate the following advice:  "Thus grief still treads upon the heels of pleasure: Married in haste, we may repent at leisure."

Taking a page from the Book of Chutzpah, I will slightly alter the famous part of Sharper's advice,  put the resulting barb into a cartridge, load the cartridge into a blow-gun, and taking deadly aim, send it directly into the heart of the Senate Republican caucus. To wit:

                                              They who legislate in haste must expect to be invalidated at leisure.

247 days down, 1,193 to go.

Copyright©2017 Kurt F Stone

Zelig Eshhar: Putting Cancer in the Rear-View Mirror

                        Professor Zelig Eshhar

(Introductory Note) Back in early June when this blog moved to its present site, the subtitle also changed: from "Formerly 'Beating the Bushes'" to "Politics and a Whole Lot More."  Well, this week is mostly "A Whole Lot More" and a tiny bit of "Politics." The underlying basis for this week's piece comes from an aspect of my professional life which I have rarely, if ever, written about.

For nearly 2 dozen years, I have served as a "community member" of two different Institutional Review Boards; first, Cleveland Clinic Florida and, for going on five years, Schulman Associates IRB (Institutional Review Board).  It is our job to carefully screen, edit and approve medical research projects - some dealing with surgical procedures, some pharmaceuticals and yet others, visionary techniques.  Our "primary directive" is to help safeguard the rights of research subjects and to make sure that all research is carried out in an ethical manner.

Over these many years, I have read, digested (to the best of my lay ability) and edited easily more than 1,000 research protocols.  By this point in time, I guess you could say that I qualify, medically speaking, as either a "lay professional," or perhaps a "professional layperson."  For it is my job to translate medical and scientific terminology into understandable English at, say, an 8th or 10th-grade level.  

Having written this, let's enter enter the world of Zelig Eshhar, cancer research and CAR-T . . . 

There's a pretty good chance that few, if any who are reading this piece have ever read or heard of Zelig Eshhar, let alone be conversant with the medical acronym CAR-T.  Trust me when I tell you that shortly, that's going to change; that both Professor Eshhar, an Israeli immunologist at Israel's Weizmann Institute of Science and his breakthrough research will become as well known as penicillin, Viagra and joint replacement surgery.  

Professor Eshhar's breakthroughA is called CAR T Therapy, which stands for Chimeric Antigen Receptor T-cell Therapy.   T-cells are the white blood cells that fight foreign or abnormal cells, including cancerous ones. Under normal circumstances, T-cells try to fight cancerous cells – but because the body has been weakened by the cancer, the response is usually not strong enough to prevent the spread of cancer. In addition, cancer cells are genetically programmed to evade T-cells - essentially to see them as "the enemy." Dr. Eshhar figured out a way around this by extracting T-cells from the patients and then genetically modifying them to develop longer-lasting and more aggressive responses to the disease. As a result, research subjects experienced significant improvement – and even elimination of the disease altogether.  In a sense, what Dr. Eshhar's process does is retrain T-cells and put them back into the body. CAR T therapy represents a quantum change in both theory and practice.  Instead of using chemotherapy, which is essentially a poison used to kill various tumors or cancer cells, CAR T takes an immunological approach in which one's own body provides the "slaying" mechanism.

Chemo drugs are huge money-makers for the pharmaceutical industry.  Various companies - such as Roche, Novartis and Eli Lilly pour tons of money into researching what they hope will become the next blockbuster drug.  And if (and when) they come up with a drug that works on a particular type of cancer (breast, prostate, lung, pancreas, etc.), it can be worth billions of dollars in global sales. 

Currently, the biggest sellers are:

• Roche's Avastin (Bevacizumab) with global sales of $6.7 billion;  used to treat breast, colorectal , kidney and ovarian cancers. 
• Celgene's Revlimid (Lenalidimide) with global sales of $4.2 billion;  used to treat Multiple myeloma (a cancer of plasma cells)
• Roche's Retuxin (Rituximab), with sales of $7.5 billion; used to treat non-Hodgkin's lymphoma (a cancer that starts in white blood cells called lymphocytes)
• Roche's Herceptin (Trastuzumab) with sales of $6.5 billion (used to fight a type of breast cancer called HER 2+)
• Johnson & Johnson's Imbruvica (Iritunib capsules) with sales of $5.3 billion (used to treat certain kinds of leukemia - a blood cancer - and lymphoma.

(BTW: many chemotherapy drugs you see advertised on TV end in either mab or nib. The former stands for "Monoclonal Antibody," [a  type of protein made in the lab which can bind itself to substances in the body like cancer cells]; the latter stands for a small molecule Inhibitor. A nib drug blocks [inhibits] the cell's ability to divide and grow.)

CAR T-cell Therapy is a horse of a different color. As Professor Eshhar explains it, "T-cells and antibodies in patients and animals are part of the immune system, capable of distinguishing tumor cells from normal cells. These cells, however, are not enough to fight the cancer cells, which manage to “evade and avoid them. The end result is cancer and an immune system that is not efficient enough to thwart it."  Stumped by this reality, Eshhar decided to combine the antibodies with the T-cells, figuring, in his words that "Two are better than one."

What he did was extract the T-cells and genetically engineered  them to include a molecule that has the cancer recognition skills of both the antibodies and the T-cells. The modified T-cells were then injected into patients. As Eshhar explained it, these T-cells “now recognize the cancer and will now be efficient because I engineered them so they will attack the cancer."  This is the simple essence of Chimeric Antigen Receptors.  To date, this process has shown spectacular success; so much so that the company which began experiments with CAR-T - Kite Pharma - was just bought out by Gilead Sciences, Inc. for a whopping $12 billion.  Not bad for a company (Kite) which has never turned a profit.

And so, cancer care has taken a gigantic, formative step; away from medicines on the chemical level and towards therapy on the genetic.  The growth and acceptance of Eshhar's technique is moving as a geometric rate.  Just 4 days ago, the Food and Drug Administration (FDA) approved Novartis' CAR T-cell therapy for young people up to age 25 with a form of leukemia called "acute lymphoblastic leukemia" - a type of cancer of the blood and bone marrow that affects white blood cells.  And just last month, the online Genetic Engineering and Biotechnology News reported the first successful use of CAR-T in  therapy for Glioblastoma Multiforme (GBM), a virulent, fast-growing type of central nervous system tumor that forms from supportive  tissue of the brain and spinal cord.  (This, by the way, is the type of cancer that Arizona Senator John McCain recently had surgery for. The average survival for malignant glioblastoma is around 14 months.)

Various research projects involving CAR-T have shown startling results ranging from total remission of certain types of cancer to its total disappearance.  More time, more dollars and more research will be needed before it can be declared "the silver bullet" in cancer treatment. But for now, it is terribly exciting, extremely hopeful and awesomely imaginative.  When asked how much money he could make off the sale of KITE Pharma (on whose Scientific Advisory Board Professor Eshhar serves), the good doctor responded "I am not a banker and I don’t know the laws. I don’t know how much we will get. I prefer not to relate to this. Research is what interests me, to improve the treatment and make it more effective.”

So what is this potential miracle cure going to cost?  No one knows for sure, but Novartis has pegged the price of its newly-approved CAR-T drug Kymriah at $475,000 for a single infusion, an amount that is within the range anticipated by oncologists and that Novartis characterized as "well below a price level that could be justified on cost."  As time goes by and new CAR-T medicines become available, the price will likely come down. But make no mistake: for the foreseeable future, it's going to be a highly expensive therapy.  But in an article published just a couple of days ago the online Life Science Washington experts anticipate that "Through further collaboration between academic groups and industry, and with a greatly improved local infrastructure, and an increased understanding and predictability of therapy resistance, there is great hope that CAR-T will become an efficient and affordable therapy – for the benefit of everyone."

In my introductory remarks I noted that this week's piece was "mostly 'a Whole Lot More' and a tiny bit of 'Politics.'"  So where does politics enter the realm of CAR-T?  In this one closing thought:

The progress that can and should be made in this ground-breaking therapy will require a staggering investment - both on the part of big pharma, foundations and the federal government.  Regrettably, this is all happening at the very moment in which the administration has proposed cutting funds for the National Institutes of Health (NIH)  from $31.8 billion to $26 billion. They are also seeking a $1 billion cut in funds for the National Cancer Institute.  It doesn't take a genius to realize that this is bad, bad timing. Hopefully Senator McCain, who is one of the most widely respected voices on Capitol Hill, will be able to convince his colleagues to stem this heartless tide.

Then too, it is indeed highly ironic that a world class Israeli immunologist working at an Israeli institute, (and assisted by scientists named Kohn, Levy and Rosenberg) should be getting his most deserved moment in the sun at  precisely the same time that neo-Nazis and white supremists are airing their diabolic dreams and desires in front of every camera and microphone pointed their way.  God forbid any of them should wind up needing CAR-T therapy.  Will they turn it down because its "parents" are Jewish . . . ?

Copyright©2017 Kurt F. Stone

Ironic? Definitely. Irenic? One Can Always Pray.

                               Rep. Steve Scalise (R-LA)

Like millions of Americans, I am praying for the recovery of Louisiana Representative Steve Scalise, the House Majority Whip who was critically wounded by a deranged gunman during an early-morning baseball practice nearly two weeks ago.   In the shooting, in which four others were injured, Scalise was only struck once, far from his most vital organs. However, the bullet traversed his hip, shattering bones and unleashing concussive forces that caused severe internal bleeding and organ damage. When he was medevaced off the field, he was reportedly conscious and in good spirits. By the time he arrived at MedStar Washington Hospital Center, in the District of Columbia, he was in critical condition: unconscious, and on the brink of death.  One hopes that the relative dearth of daily news about the congressman's progress is a good sign . . . the "No News Is Good News" syndrome. Indeed, as of the middle of last week, after three surgeries (with the prospect of several more to come), his condition had been upgraded to "fair."

Through no fault of his own, Rep. Scalise has now incurred hundreds of thousands - if not millions - of dollars of future medical expenses.  Fortunately, he is covered by some pretty good health insurance and thus will likely wind up being responsible for only a tiny fraction of these costs.  Now, contrary to the widespread urban legend that members of Congress receive free health insurance for life, Scalise and his colleagues are, ironically, covered under Obamacare.  They sign up through the District of Columbia exchange; the Federal Government pays about 70% of their monthly premium.  It's a good deal; especially for a member like Steve Scalise.  For contrary to the notion that all members of Congress are multimillionaires, Rep. Scalise is, according to the most recent figures (2015), the 19th poorest member of the legislative branch, with a net worth of at least minus $20,999.00  (Actually, this is a vast improvement; in 2007, the year he was first elected, Rep. Scalise reported a net worth of minus $421,438.00.)  

And here's where irony comes in:  Like virtually all of his Republican colleagues in the House, Rep. Steve Scalise voted to (mostly) repeal and (just about totally) replace the very system of healthcare which will save him from even greater and graver financial disaster. For without many of the Affordable Healthcare Act's (Obamacare) best-wrought clauses, Rep. Scalise - like somewhere around 20-24 million other Americans would - were he not a member of Congress - be in dire shape.  The "American Health Care Act" (ACHA) passed by the House back on May 4th,  includes an amendment that would allow states to obtain waivers from certain insurance requirements mandated by the Affordable Care Act. States could get waivers to: increase how much insurers can charge based on age, establish their own requirements for essential health benefits that plans must include, and allow insurers to price policies based on health status in some cases. That last waiver could lead to higher premiums for those with preexisting conditions who don’t maintain continuous coverage.  An amendment — penned by New Jersey Rep. Tom MacArthur — specifically exempts Congress and its staff from the effects of such state waivers.  It must be admitted that this was done for procedural, not political reasons a bit too arcane to be gone into in this piece. A second, stand-alone bill proposed by  Representative Martha McSally (R-AZ) would strike the exemption of Congress from state waiver provisions should the AHCA be enacted into law.   Crazy, no?  But in any event, Representative Scalise - like so many of his fellow Americans - is going to be way behind the financial eight-ball should this hastily-drawn, monstrously conceived legislation get to the president's desk for final approval.

A reasonable political observer might expect the case of Rep. Scalise to be brought up again and again in the AHCA debate.  After all, it is an enormous elephant in the legislative room.  But as reasonable as this might seem, it is not likely going to happen; neither Republicans nor Democrats are going to be mentioning the name "Steve Scalise" - unless attached to the words "Our thoughts and prayers . . ."  Why is this?  Well, as The New Republic's Brian Beutler succinctly put it in a recent article, "Republicans are the governing majority, they have no interest in letting Scalise’s ordeal become a symbol of anything related to health policy . . . . Democrats have been reluctant to politicize the shooting for different reasons: Scalise is a colleague, the dead shooter was a former volunteer for Bernie Sanders’s presidential campaign, and the media surely would have punished anyone who interrupted the Kumbaya moment on Capitol Hill. Fascinatingly, since the ball-field shooting, none of the normal post-slaughter debate over "More guns vs. Better gun control" has been heard; and I mean nary a peep.  Perhaps this Kumbaya moment  in the case of guns will extend to the current healthcare debate.  Then again, perhaps that's a bit overly Pollyanna.  At least while we are praying for Rep. Scalise's recovery, we can pray for a bit more sanity.

The recently released Senate version of the ACHA (now called The Better Care Reconciliation Act of 2017) is - if possible - even worse than that which passed the House last month.  Like the House version, it is ruthless, soulless and vicious; it ensures that healthcare premiums are going to become out of reach for older, less healthy Americans as more and more younger and healthier Americans decide they simply don't need coverage.  It will gut Medicaid, which is a lifeline for a tremendous number of Americans.  Consider that

• 20 percent of Americans are enrolled in Medicaid;
• 39 percent of children in the US are enrolled in Medicaid;
• 49 percent of births are covered by Medicaid; and
• a full 64 percent, or nearly two-thirds of nursing home patients, are covered by Medicaid. 

In a world ruled by sanity, insurance costs and healthcare deductibles are kept in check by having the maximum number of people - people of all ages and stages of well-being - sharing costs.  Republicans of all stripes - and some Democrats - have long argued that requiring people to purchase coverage is wrong, unconstitutional and even Socialistic.  Make no mistake about it: even greater than their hatred of "individual mandates" and "shared responsibility" is their love of extraordinarily generous tax cuts for their already hyper-wealthy backers and benefactors.

And yet, beyond the irony of Rep. Scalise's perilous condition during the very time healthcare is a central focus, is the possibility of the irenic moment this irony could provide.  For those who do not do crossword puzzles, the word irenic may be unknown.  It comes from the Greek word ειρήνη (eirēnē), meaning "peace."  In theology, it specifically  connotes the process of reconciliation between different denominations or sects of a religion.  And that is what this ironic moment could be providing: ειρήνη - a coming together, a reconciliation between those who believe healthcare for all is a right, and those who hold that tax-cuts for the few is a given.  As The New Republic's Beutler wisely notes, "The best thing that could possibly come of Scalise’s shooting wouldn’t be some fleeting moment of political unity. It would be pulling Republicans back from the brink of trading American lives for tax cuts."

How ironic.

156 days gone, 1,301 to go.

Copyright©2017 Kurt F. Stone