#979 Paul Alexander: Inspiration and Determination; Validation and Immunization

March 18, 2024 / Kurt F. Stone

Throughout childhood, our maternal grandmother, Anne Kagan, would frequently read aloud to us her favorite poems from a dog-eared volume entitled One Hundred and One Famous Poems. Unbeknownst to us, she was providing the two of us with a glorious, absolutely pain-free introduction to some of the English language’s greatest (and occasionally, long-forgotten) wordsmiths. Time and again we would listen to her read (and quite dramatically, I must say), from Keats (Ode On a Grecian Urn), and Byron She Walks in Beauty); to Kipling (If) and Wordsworth (She Was a Phantom of Delight); and from Whittier (The Barefoot Boy) to Kilmer (Trees).

A couple of days ago, I read the obituary of a man named Paul Alexander . . . a man who, due to polio, was forced to live from ages 6 to 78 in an iron lung. The opening paragraph of the New York Times obit told the entire story: Alexander relied on the machine to breathe. Still, he was able to earn a law degree, write a book and, late in life, buil[t] a following on TikTok.

The poem his utterly remarkable life brought to mind was Frank Lebby Stanton’s Keep A-Going!, whose opening stanza I can still hear Grandma Anne reciting from memory:

Ef you strike a thorn or rose,
Keep a-goin'!
Ef it hails, or ef it snows,
Keep a-goin!
'Taint no use to sit an' whine,
When the fish ain't on yer line;
Bait yer hook an' keep a-tryin'—
Keep a-goin'!

I really, really urge you to read Mr. Alexander’s obituary. The story of his life is truly remarkable; in its own way, it rivals that of Helen Keller, who despite being blind and deaf, somehow managed through determination and pluck, a remarkable caretaker and a “never say die” attitude, managed to become the first deafblind individual to graduate from college (Radcliffe College, class of 1904), become a prominent lecturer and author (12 books) and learned to “hear” people’s speech via the Tadoma Method, in which she used her fingers to feel the lips and throat of the speaker. Keller even wrote her first autobiography while studying at Radcliffe. Without question, she, like Paul Alexander, are among history’s greatest inspirations.

In 1952, the then 6-year old Paul was stricken with Polio. It came on seemingly in a day, quickly paralyzed limbs and and left him incapable of breathing on his own - the muscles which control respiration had become incapable of movement. He was quickly placed in an “iron lung,” became worse and worse, and was eventually sent home from hospital to die at home. But he did not. When he was 8, Paul learned to breathe on his own for up to three minutes by gulping in air “like a fish” and swallowing it into his lungs, he told The Dallas Morning News years later. He told the newspaper that he was motivated to learn to breathe by a caregiver who offered him a puppy if he tried to learn to breathe on his own. He got his puppy, and it later became the inspiration for the title of his book, Three Minutes for a Dog: My Life in an Iron Lung. He learned to write by gripping a long, narrow tube with his teeth; at the end of the tube was a pen or pencil. By painstakingly moving his head, he could put words to paper. He managed to graduate from law school, and was a practicing attorney for more than 30 years . . . all the while being trapped (except for upwards of 3 hours a day) in his iron lung. At his death this week, there is now but one person still living in such a device.

Those of us who were children in the 1950s well remember the panic and fear that Poliomyelitis caused. As children, we had no idea of what caused it and had nightmares about catching it. During the early 1950s, 25,000 to 50,000 new cases of polio occurred each year. Jonas Salk (1914–1995) became a national hero when he allayed the fear of the dreaded disease with his polio vaccine, approved in 1955. Although it was the first polio vaccine, it was not to be the last; Albert Bruce Sabin (1906–1993) introduced an oral vaccine in the United States in the 1960s that replaced Salk’s. (The main difference between the two vaccines was that Salk’s - the first - was made with a “killed” virus and administered by tiny needle pricks on the upper arm, while Sabin’s was made with a live though weakened [attenuated] virus and was administered orally via a sugar cube). By the 1970s, Poliomyelitis was essentially eradicated . . . along with the post-war era’s other monster pediatric stay-home-from-school issues: mumps, measles and chickenpox. Today, those 70 years and older have memories of staying home from school; of spots; of having to stay in darkened rooms and calamine lotion; of “chipmunk cheeks” and the possibility of lethal sequelae (side effects) such as a brain infection called encephalitis, which causes it to swell. And then there was chicken-pox, which caused unbelievable pruritus (eternal itching) and necessitated keeping one’s nails very, very short. Some of us still bear its tiny scars . . . especially on the arms, legs and cheeks.

Although these mostly childhood diseases were finally brought under control because of vaccines - Salk, Sabin and “MMR” (mumps-measles-rubella) - the science behind them fired up debates that continue to this day. Why? Partly because many post “Baby Boom Generation” folks (and their children and grandchildren) don’t know drek from shinola about history; they simply have little or no knowledge of these childhood diseases, and claim to have “knowledge” (gained largely through mis- and disinformation spread by social media) that vaccines are a hoax, science itself is a hoax; that when a governmental body or agency mandates children to be immunized before attending school this is a breach of parental authority . . . or part of a Zionist conspiracy (remember: both Salk and Sabin were Jewish) or the CDC is a mere lapdog of the liberals . . . or a thousand other things. Here in Florida, our Surgeon General, Joseph Ladapo, M.D. recently said in a letter that parents at an elementary school with confirmed measles cases can decide whether their children should attend school. This simply contradicts widespread medical guidance about how to keep the disease from spreading. And spreading it is. However, in all fairness to “The Doctor from Perdition” he’s merely serving the man who hired him, Governor Ron DeSantis, with every ounce of his being. I’m sure he must have learned in his Infectious Diseases course at Harvard Med. that Measles is one of the world’s most infectious diseases. Cases and deaths have been rising across the globe, in part because health officials have struggled to vaccinate people in the wake of the coronavirus pandemic and growing vaccine hesitancy.

The same goes for Polio - the disease which kept Paul Alexander imprisoned in an iron lung for more than 90% of his life. It has resurfaced . . . in Afghanistan, Pakistan, Israel and the United States. Answering the question “why now?” isn’t totally clear. However, at base, it seems to stem from a growing percentage of the child population not being vaccinated at an early age. Then too, there is the whole “anti-vaxxer” craze in which “knowledgeable” parents refuse to have their children immunized with the aforementioned “MMR” vaccine because they have “read” that it can lead to autism. And even if you were to ask most anti-vaxxers “which studies state this?” they will be mute. Professional anti-vaxxers like Robert F. Kennedy, Jr. (who is now running as an independent for POTUS) will site 2 studies - both of which were determined to be fatally flawed. The 2 studies, which were published in the prestigious British medical journal The Lancet (Published since 1823, it’s on a par with the Journal of the American Medical Association) were so egregiously, so dangerously flawed, that Wakefield (1956- ) was struck off the medical register in the United Kingdom - tantamount to losing his license to practice. And yet, even if anti-vaxxers don’t know his name and cannot identify The Lancet, they continue spouting their bilge.

I think I understand why an ever- growing number of people believe in anti-vaxx myths; they are afraid, frustrated and taught to distrust science and the so-called “intellectual elite.” What I cannot fathom are the creators and perpetrators of all these dangerous myths; what’s behind their willful perfidy? Is it for political gain? Is it for profit or ego enhancement? Or is it for picking off “low-hanging fruit” on the tree of society, in order to eventually fell the tree itself?

It is a pity that a significant percentage of the so-called “enlightened” populace are anti-science . . . in the name of personal liberty or religious freedom. I think of Paul Alexander who, if he’d only been born a few years later, would likely have received a Salk vaccine and would never have had to live out his life in an iron lung. What he was able to accomplish despite this multi-ton millstone that kept him alive is a story for the ages . . . and hopefully a source of inspiration for us all.

When it looks like all is up,
Keep a-going’!
Drain the sweetness from the cup,
Keep a-agoin’!
See the wild birds on the wing,
Hear the bells that sweetly ring,
When you feel like singin’ - SING —
Keep a-going’!

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categories / Obituary, Medical Ethics, Conspiracies

#945: The Long Goodbye

July 11, 2023 / Kurt F. Stone

It was my original intention that this week’s essay would be about Robert F. Kennedy, Jr., who as of about a month ago, is an announced candidate for the Democratic nomination for President. Towards that end, I read up on him, the place he occupies in his famous family, the books and articles he has published over the past 30 years, his work as both an environmental lawyer and “position” as one of the nation’s leading conspiratorial “anti-vaxxers,” and his stances on a wide range of political issues. My main interest in writing about him was trying to figure out how a person with his pedigree (not to mention troubled life) could even consider running as a political “outsider." I mean, the dude’s a Kennedy for crying out loud. Then too, I was (and still am) fascinated by how one moment Junior can come off as an ultra-right wing populist with a conspiratorial streak that would please the likes of a Roger Stone or Steve Bannon, and the next sound like a Kennedy - a progressive friend of the masses.

Actor Bruce Willis: Now in the throes of FTD

But after reading journalist Rebecca Traister’s masterful piece, RFK’s Inside Job in the June 30th issue of New York Magazine, I changed my mind; Ms. Traister had written - and far, far better than I could ever hope - the piece I had in mind. And so, wishing to clear my mind of RFK, I instead aimed my brain towards my twice-weekly Institutional Review Board (medical ethics) material. And there, right before my eyes, was an announcement from the FDA that it has just granted full approval to Leqembi (l’-kem-bee), the first drug to clearly, but modestly, slow the progress of Alzheimer’s Disease (A.D.). And suddenly, it came to me: I would write about this medical mini-breakthrough . . . the very kind of thing that RFK, Jr. might well understand to be part of a conspiracy to endanger dementia sufferers while enriching “big pharma.”

Leqembi (LECANEMAB-IRMB), co-researched and manufactured by the pharmaceutical company Eisai in Tokyo and Biogen in Cambridge, Mass., is a monoclonal antibody (a lab-made protein), that targets amyloid beta in the brain. (Don’t worry if you don’t know what amyloid beta means; there isn’t going to be a test at the end of this essay. All you need to know is that A.D. is largely caused by the build-up of “plaque” in brain, and that plaque is largely made up of amyloid beta. And by the way, all those drugs whose names end in mab . . . this stands for “monoclonal antibody”).

Dementia is an umbrella term used to describe a range of neurological conditions affecting the brain that get worse over time. As of today, none can be cured, let alone slowed. Of all the various forms of human dementia (estimated to be as many as 400), the very worst (and least-known) are:

Creutzfeldt-Jakob disease (CJD) which causes a type of dementia that causes personality changes, anxiety, depression, and memory loss, usually within a few months.
Dementia with Lewy Bodies: a type of progressive brain disorder in which Lewy bodies (abnormal deposits of a protein called alpha‑synuclein) build up in areas of the brain that regulate behavior, cognition, and movement.
Huntington’s Disease, (“Woody Guthrie Disease”): a progressive brain disorder caused by a defective gene. This disease causes changes in the central area of the brain, which affects movement, mood and thinking skills;
Frontotemporal Dementia (FTD): One day this will likely be known as “Bruce Willis Dementia.” FTD refers to a group of disorders caused by progressive nerve cell loss in the brain's frontal lobes (the areas behind the forehead) or its temporal lobes (the regions behind the ears). For many, the initial diagnosis is Aphasia, a disorder that results from damage to portions of the brain that are responsible for language. Before he was diagnosed with FTD, Mr. Willis announced his retirement due to an inability to remember - let alone pronounce - the words of a movie script.

The type of dementia which afflicts the greatest number of people world-wide is Alzheimer’s. According to the Alzheimer’s Association, more than 6 million people in the United States alone are living with the disease.

Each of these forms of dementia (and oh so many others), have their own foundations which support research. Many of these afflictions have clinical trials in progress. They are underwritten by these foundations, by wealthy family members of people suffering from these illnesses, by university med schools, by for-profit pharmaceutical companies, and the federal government. According to Clinicaltrials.gov, the U.S. National Library of Medicine, there are currently 3,158 ongoing studies into A.D. alone. These range from Phase I to post-marketing studies. All are seeking the same thing: to lessen, abate and eventually one day find a cure for this disease. The most sophisticated of these studies are randomized (subjects are chosen by a computerized “flip of the coin”), double-blind (neither the subject nor the medical investigators know which dose the participants are receiving), and placebo-controlled (in which a “dummy lookalike drug” is used in order to determine whether or not the drug being investigated is potent).

Returning to Leqembi, the newest FDA-approved drug for A.D. Studies show that it has slowed cognitive decline by 27 percent over 18 months compared with a placebo (a dummy, lookalike drug). This represents a five-month delay in progression — dismissed as negligible by some but hailed as a milestone by others for a malady that has, up until now, been largely untreatable. Not surprisingly in this day and age, there are naysayers who only talk about Leqembi’s potential side effects (“adverse events” in medicalese). Skeptics also note that the drug’s effectiveness is limited — perhaps too subtle to be noticed by a patient — and that the medication can cause potentially dangerous brain swelling and bleeding. The drug is expensive — $26,500 per year. And Medicare is imposing conditions on coverage, a move fueling a bitter battle between government officials and advocacy groups.

At present, it appears that Medicare enrollees in the Original Medicare will have to pay a co-payment of 20% of the cost of the drug, after meeting their deductible. This means that people on Original Medicare could pay about $5,000 out of pocket annually for Leqembi, according to health-care research group KFF. Medicare Advantage enrollees typically pay 20% of a drugs' costs, up to their plan's out-of-pocket maximum, KFF noted, which means that people on these plans may also face high out-of-pocket costs for the medication.

All drugs and procedures have potential side effects; by law they must be made known to subjects in clinical trials and when approved, to all those who will be taking the medication. For a segment of society, the fact that Leqembi (or any other medicine) has side effects is unacceptable. That’s where conspiracies come in. (It should be noted that the most-cited of these Leqembi adverse events was “brain bleeding” (ARIA — amyloid-related imaging abnormalities). Upon further investigation it turned out that many who had this problem (which is, generally has few - if any - visible symptoms) were taking blood-thinning medications such as Plavix (clopidogrel) and Coumadin (warfarin). Once the blood-thinning dosages were lowered or eliminated, the incidence of ARIA lessened.

Remember all those - including RFK, JR. - who claimed - against all credible medical proof - that the MMR (Measles, Mumps, Rubella) vaccine caused autism in children? Despite being thoroughly disproven and discredited by medical researchers around the globe, there are still people who firmly believe that the vaccine is all part of a conspiracy. The same is true with virtually every COVID-19 and SARS (Severe Acute Respiratory Syndrome) vaccine approved for use over the past several years. Let’s face it: no medicine, whether taken orally, injected just under the skin (sub-Q) or infused (IV) is 100% safe. Why? Because subjects and patients, like the people who do research, are human beings . . . less than perfect. And many times subjects and patients have other things wrong with them (these are referred to as “comorbidities”) which may or may not cause a pill, shot or infusion to create a problem. But even if a small percentage suffer a problem - such as diarrhea, hair-loss or even, God forbid, death, what about the nearly 95+% who find improvement? Are we to put huge roadblocks along the path to improvement - if not eventual recovery - because of the very, very few?

Alzheimer’s disease and other pre-senile dementias are often referred to as “the long goodbye.” It is an apt expression, which also happens to be the title of a 1953 Raymond Chandler novel starring his L.A. detective Phillip Marlowe. As anyone who has ever watched a loved one slip into the shadows of dementia, they know what it feels like to be left facing and caring for a stranger with a familiar face. It is a pain far worse than a spinal tap. In an era where people without a stick of real medical knowledge or a single unit of scientific study (save, perhaps a 3-unit class in Biology 1), there are many megaphoned maniacs getting a growing segment of the public to believe that clinical research is a “zero-sum game” between patients and profit. This is the last thing people suffering from HIV, dementia, cancer, or any of a host of horrifying diseases need.

What we need now, more than ever, is hope . . . not hysteria.

Perhaps I’ll write a future essay about RFK, Jr. after he’s gotten over his current manic obsession with becoming President of the United States. Until then, I will pray for his health and for the health of all the doctors, nurses, pharmacologists, biomechanics, and medical ethicists who are daily engaged in the art and science of healing.

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categories / Medical Ethics

#933: "A Toad Under the Harrow"

April 16, 2023 / Kurt F. Stone

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.)

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.”

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categories / Healthcare, Medical Ethics, Religion and Politics, The American Judiciary

Are Medical Ethics an Oxymoron?

October 23, 2022 / Kurt F. Stone

The other day, while standing in a supermarket checkout line, a fellow standing behind me heard the cashier greet me by saying “How ya doin Doc?” The fellow asked me “Are you a doctor? You look like one.” (I was clad in a blue pinstripe suit, maroon tie and matching show hankie, topped off with a Panama hat.) “Sort of,” I said to the man, who was wearing a tank-top sporting colorful tats from shoulder-to-wrist.

“What’s that mean. . . sort of? he asked. “I work in the field of medical ethics,” I replied, waiting for what, after nearly 30 years, is a pretty common response. “Isn’t that kinda contradictory?” he asked, a toxic grin on his face. “You mean like oxymoronic?” I asked. His face turned blank, as if he were wondering whether or not I had just called him a moron.

“So tell me,” he said as I started to insert my debit card into the reader, “what do you think of this Dr. Fauci?”

“I think he’s one of the greatest, most brilliant and humble people on the planet,” I said, giving him a broad grin. “And what do you think about him?” I asked.

“I think he’s killed more people than just about anybody in history,” he said . . . just challenging me to get into an argument.

“And how is that?” I asked. “I have always considered him to be a most honorable fellow.”

“Don’t you know? He’s the guy who created COVID-19 in some Chinese laboratory just so he could make billions from selling a phony cure.”

That’s where the conversation ended. Fortunately, the cashier had completed his task, loaded up my recyclable bags, and said “see you next time, Doc.” He imperceptibly jerked his head in the direction of the fellow behind me as if to say “jeez . . . what a moron!” At least it didn’t come from me.

I learned a long time ago never to get into an argument with an idiot . . . or a conspiracy buff . . . especially when it comes to an area where I know a thing or two. I have neither the time to bang my head against a brick wall, nor any particular love of concussions.

Hippocrates, widely considered one of the most outstanding figures in the history of medicine, laid down the first principle of medical ethics: primum non nocere (hoc est, “First, do no harm”). Over many centuries and innumerable plagues and pandemics, an inviolate code of ethics has attached itself to the healing arts. The modern field of medical ethics owes a great deal to the Third Reich, whose doctors, it was discovered during the post-war “Doctors Trial” (officially called United States of America v. Karl Brandt et al), held in Nuremberg at war’s end, of the grossly inhumane “medical procedures” that were carried out on human beings without their knowledge or consent. So breathtakingly shocking were the results of these 12 trials, that a new field - medical ethics - was born.

The 4 most overarching principles of this field of medicine are:

Autonomy (Respect a person’s right to chose what’s right for them);
Non-maleficence (Do no harm);
Beneficence (All choices for a patient are made with the intent to do good). and
Justice (Treat and provide care fairly to all patients).

For close to 30 years, I have served as a member of an “Institutional Review Board” (IRB), a group made up of physicians, scientists, pharmacologists and multidisciplinary academics, who are charged with safeguarding both the rights and the safety of those who participate in clinical trials (medical research). Personally, I attend a minimum of 2 teleconferences each week, during which we review anywhere between 3 and 15 new medical trials, research modifications, and what are called “continuing reviews.” it represents a tremendous amount of research and work, but ultimately is as rewarding (and demanding) as anything we have ever done.

At any given teleconference, we might be dealing with studies involving multiple myeloma (a dangerous form of cancer), amyotrophic lateral sclerosis (ALS - “Lou Gehrig’s Disease”), Crohn’s Disease (“Terminal Ileitis”), Osteogenesis Imperfecta (“Brittle Bone Disease”) or Acromegaly (a rare disease resulting from excessive production of growth hormone) or hundreds of others. Before we begin our meetings, we must swear that we have no financial conflicts of interest with the clinics, corporations or universities engaged in research . . . just to make sure that everything is on the up-and-up.

Make no mistake about it: creating new drugs and medical devices, or seeking to determine if an FDA (Food and Drug Administration) drug can effectively be used for a non-approved purpose, is a lengthy and extremely expensive proposition. For every Viagra (Erectile Dysfunction), Remicade (Crohn’s Disease), Celebrex (Osteoarthritis) or Synthroid (hypothyroidism) which rake in billions upon billions of dollars, there are literally thousands which will never earn a penny . . . let alone receive FDA approval. Sometimes, the research money is provided by ”big pharma”; sometimes, it comes from the Federal government.

When done properly, clinical trials can take years, and be painfully slow. And like it or not, this is just the way things should and must go. Short-cuts can lead to medical catastrophes. Who remembers the “Thalidomide babies” tragedy of the 1950s? Research on Thalidomide had begun to show the drug’s effectiveness in alleviating nausea in pregnant women, and many physicians started prescribing the drug off-label as a treatment for morning sickness. Not long after Thalidomide started being used for this purpose, physicians and scientists began observing birth defects in children born to mothers who had taken Thalidomide during their pregnancy; studies showed that exposure was particularly dangerous for infants born to mothers who had used the drug approximately 20—34 days post-fertilization. Common birth defects seen in these children included deletion of the ears, deafness, severe underdevelopment or absence of the arms, defects in the femur and tibia (bones of the legs), and many more. (Today, Thalidomide is still being prescribed . . . but for the treatment or prevention of certain skin conditions related to Hansen's disease (once known as leprosy) and to treat a certain type of cancer called multiple myeloma (cancer of mature plasma cells in the bone marrow). But back in the day however, Thalidomide had not gone through nearly as extensive research and rigorous oversight as it has in the couple of generations.

But frequently, when a disease hits close to home - one which profoundly changes one’s way of life, such as with paralysis, memory loss, or one which could lead to early death - such as COVID19 - people demand that the medical ethics community throw oversight rules out the window and provide assistance . . . even if the drug or device is not approved . . . or worse, breaks the first principle of medical ethics, by “doing harm.”

The best - and most recent - example of this came not from the CDC, FDA or any researcher of note, but rather from the FPOTUS, who flatly announced to the world that he recommended taking the anti-malarial drug Hydroxychloroquine as a cure for COVID-19. And despite a rapid and all-but unanimous thumbs-down from the medical and scientific community, Trump’s friends in the alt-press community actually touted “research” which “proved” that the medicine could increase survival rates by 200%. (This was actually posited in an edition of the USA Sun which, by the way, is a Rupert Murdoch-owned tabloid. Surprise surprise!)

As a result of increasing pressure from patients (and families) of those suffering from serious, debilitating and/or lethal diseases, the FDA has begun approving the use of medical treatments with drugs which, even though likely to be safe, have not yet proven to be efficacious. Two examples:

The agency recently approved a treatment for A.L.S., (“Lou Gehrig’s Disease”), a fatal neurological disorder, despite questions about whether the drug, called Relyvrio, will extend patients’ lives or slow the progression of their disease. Because the drug appears safe, the agency reasoned that “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.” The F.D.A. could withdraw the drug’s approval at a later date if ongoing confirmatory trials showed poor results.
In 2021, the F.D.A. issued a controversial approval of the Alzheimer’s drug Aduhelm, through one of its programs to speed access to new treatments, called “accelerated approval.” An advisory committee for the agency determined that there wasn’t strong evidence that the drug worked, but the F.D.A. gave the green light anyway, to the delight of some patients and advocacy groups.

There is also an approval rating that the FDA can grant a drug or device, which can make it approvable for “Humanitarian Use Only.” We see these from time to time; they are generally reviewed on a case-by-case basis, and are closely scrutinized before being granted. This does not mean that the Hippocratic Oath has been cast onto the trash heap; rather it points to medicine’s ability to balance science with compassion. This gives me no pause.

What does concern, however, me is that increasingly, pressure from pharmaceutical companies, families and even regulators (such as the FDA) is becoming the bedrock of a new trend: prioritizing access to unproven medical products over gathering evidence that they safely work. As the noted bioethicist Dr. Allison Bateman House, Assistant Professor, Division of Medical Ethics, NYU Grossman School of Medicine, notes recently in a New York Times op-ed piece, If this trend continues, it could result in people increasingly using and paying for ineffective and possibly unsafe medical products. In the worst case, it could mark a return to an era when drug-related harms occurred under insufficient regulation.

In a time when increasingly, the findings and lessons of specialists and experts in many fields - and not just medicine - are being cast aside in favor of the fact-free supporters of hidden agendas, there is reason for concern.

Medical ethics are not an oxymoron; they are the wall which separates fact from fiction, and Hippocrates from Dr. Mengele . . .

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categories / Medical Ethics

Replacement Theory: Eugenics Refitted in 21st Century Rags

May 17, 2022 / Kurt F. Stone

Of all the professional pursuits I have engaged in over the past half-century (Oy!), none has been more challenging or rewarding than the field of Medical Ethics. (Yes, I can hear the quip “Isn’t that a bit of an oxymoron?” for the thousandth time . . . and no, it is decidedly NOT). Medical ethics is the one field in which I truly feel I am making a difference in this world. At the same time, each day, each week, requires a tremendous amount of study, and a lot of learning. One of the things that takes up quite a bit of learning time is cramming tons of medical acronyms (such as ARDS, BPD, DVT or PML, to name but a teeny-tiny handful) and then translating them into understandable lay English for the masses. Please know that for purposes of this essay, we won’t get into even a small sampling, lest you, dear reader, fear that any of the abbreviations or terms will become part of some final exam.

G-d forbid!

Whether or not one knows the difference between “PK” (Pharmacokinetics) and PD (Pharmacodynamics) is not terribly important; it can easily be solved by asking a question or two from an expert. However, in the world of modern politics, there are tons of terms (which may or may not have their own acronyms) which are terribly important . . . such as “CRT” (Critical Race Theory), “Let’s Go Brandon,” (a right-wing code for “F*ck Joe Biden,”) and one of the newest, “Replacement Theory,” which has come back onto center-stage as a result of this week’s massacre at a Buffalo-area supermarket which took the lives of more than a dozen African-Americans.

“Replacement Theory” (often prefaced by “The Great”), first came to public attention in July, 2017, when bands of White Supremacists and Neo-Nazis, attending a “Unite the Right” rally, marched through the streets of Charlottesville, Virginia, brandishing tiki torches and chanting “Jews will not replace us!” and “You will not replace us!” Nearly two years later, two consecutive mass shootings occurred in a terrorist attack on two mosques in Christchurch, New Zealand. The attacks were carried out by a lone gunman who entered both mosques during Friday prayer; 51 people were killed and 40 injured. Prior to going on his murderous rampage, the shooter, who was eventually sentenced to 51 life terms without the possibility of parole, issued a 74-page manifesto entitled The Great Replacement. In it, he expressed several anti-immigrant sentiments, including hate speech against migrants, white supremacist rhetoric, and calls for all non-European immigrants in Europe - who he claimed to be "invading his land" - to be removed.

In last week’s mass murder up in Buffalo, the eighteen-year old terrorist, like his counterpart in the Christchurch terrorist tragedy, posted a manifesto in which he accused “Jews, Democrats and Communists” of doing everything in their power to bring about “white genocide” - of “replacing” white people with “illegal immigrants, blacks, browns and Asians” who would then vote a straight Democratic ticket with an eye to eliminating “White Christians.” Somewhat lost in the shuffle was a murderous terror attack on a Taiwanese Presbyterian church in Laguna Woods, a community in Southern California’s Orange County. Once again, the shooter - who was hogtied by members of the congregation with an extension cord - killed because he was a racist who wanted to get rid of as many “aliens” as possible. (The one person killed in the attack was John Chen, a 52-year old doctor of Sports Medicine in nearby Aliso Viejo. If not for the heroic Dr. Chen, more congregants would have been murdered. Hauntingly, he was one of my niece Julie’s physicians some years back.)

“Replacement Theory,” got its name from a 2010 work (Le Grand Remplacement) by the French writer Renaud Camus. In his book, Camus depicted a population replacement said to occur in a short time lapse of one or two generations. The French migrant crisis was particularly conducive to the spread of Camus's ideas, while the terrorist attacks accelerated the construction of immigrants as an existential threat among those who shared such a worldview. It didn’t take too long for his worldview to turn into a conspiracy theory and find fertile ground in the rest of Europe and the United States. When all is said and done, Camus’ theory is not all that dissimilar to the 19th-century atrocity known as “Eugenics” - a set of beliefs and practices which aimed to improve the genetic quality of a human population, historically by excluding people and groups judged to be inferior or promoting those judged to be superior. The Nazis - particularly Dr. Josef Mengele (Der Todesengel, the “Angel of Death”) comes to mind. From Eugenics to Replacement Theory isn’t that great a leap.

Lest we sneer at “The Great Replacement” as the special provenance of political crazies, lovers of loony conspiracy theories, fans of Tucker Carlson and garden variety Neo-Nazis and racists, consider a few horrifying facts:

About 1 in 3 U.S. adults believes an effort is underway to replace U.S.-born Americans with immigrants for electoral gains;
About 3 in 10 also worry that more immigration is causing U.S.-born Americans to lose their economic, political and cultural influence. (Republicans are more likely than Democrats to fear a loss of influence because of immigration, 36% to 27%.)
Replacement Theory has moved from the fringes into the mainstream among Congressional Republicans. With the exception of Representatives Liz Cheney (R-Wyo) and Adam Kinzinger (R-IL) who ripped their colleagues for not speaking out against White Supremacy which lay just beneath the Buffalo massacre (for which they have been roundly condemned) not a single member of the Republican caucus has said word one. Indeed, the number 3 member of the House Republican caucus (Elise Stefanik) chose to attack Democrats in general, and President Joe Biden in particular for the massacre: “Democrats desperately want wide open borders and mass amnesty for illegals allowing them to vote. Like the vast majority of Americans, Republicans want to secure our borders and protect election integrity.

Has the whole world gone crazy? Why oh why do so many people get their news and views from conspiracy-mongers who neither believe nor give a rat’s rump about so-called “White Genocide? Anyone who could come up with an answer to that question would be in the running for the Nobel Prize in either peace or medicine. As to what we can do to stifle the voices, the violence and the virulence of these monsters is a bit less confusing, but a hell of a lot more cumbersome. It is up to us, the masses of ordinary citizens - those who seek a saner and safer society in which to live, love and learn - we MUST banish the bigots, the lovers of totalitarianism, those who are more concerned with the freedom to own weapons of mass destruction than to feed the hungry, clothe the naked and live up to the nation’s slogan e pluribus unum - “Out of many, one.”

I can see no reason why we, the masses of the ordinary, cannot band together and send the haters of humanity back to their humdrum lives . . . far, far away from seats of power. Put up lawn signs; go knocking on doors, drive neighbors to the polls, and always, always remember the words of Churchill:

“NEVER GIVE UP. NEVER GIVE UP! NEVER GIVE UP!! NEVER, NEVER, NEVER,NEVER NEVER-NEVER-NEVER-NEVER!!!”

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categories / Medical Ethics, Conspiracies, All Politics All the Time

Riddle Me a Riddle

December 28, 2021 / Kurt F. Stone

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 . . .

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categories / Healthcare

We Alone Can Fix It

July 26, 2021 / Kurt F. Stone

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!

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categories / All Politics All the Time, Healthcare

Like an Exclamation Point in the Heavens

September 22, 2020 / Kurt F. Stone

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 . . .

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categories / Healthcare, The American Judiciary

From Your Mouth to God's Ear

May 17, 2020 / Kurt F. Stone

Yesterday, Friday May 15, POTUS and members of the administration confidently proclaimed that the U.S. will be able to distribute a full-scale coronavirus vaccine by the end of the year. The project, POTUS explained to the world, has been given the name Operation Warp Speed. Explaining its purpose and aims, POTUS, in an overly repetitively redundant bit of rhetorical puffery, called it “A massive scientific, industrial, and logistical endeavor unlike anything our country has seen since the Manhattan Project. You really could say that nobody has seen anything like we’re doing . . . . Nobody has seen anything like we’re doing now, within our country, since the Second World War. Incredible.” As I listened to the least truthful president in American history proclaim, once again, that his newest scientific gambit would see a successful, surefire anti-Covid-19 vaccine available for all those who want it - hopefully - by the beginning of next year, all I could think of was the old Yiddish expression “פֿון דיין מויל צו גאָט ס אויער” (pronounced fun dyne moyel tzu gaht’s aoyer, and meaning “From your mouth to God’s ears”).

From the political point of view, 45’s creation of “Warp Speed” is perfectly understandable - although filled with foul air. After having been caught accusing his predecessor of engaging in the “biggest political scandal in the history of the United States” (Obamagate) he had to quickly change lanes when Majority Leader McConnell admitted to having lied about Obama leaving the incoming Trump administration without any plan or background info on an upcoming pandemic. So how to live this down? Simple . . . a return to happy talk and empty promises. And BTW, ‘45 even managed to throw a bit of red meat to his most strident supporters by mentioning that the upcoming vaccine would only be for those who “wanted to take it” - thus leaving room for those who believe vaccines are part of a conspiracy funded by George Soros and the rest of the Lesbian Left.

From a purely scientific/medical point of view, ’45 is once again delving into areas he knows nothing about . . . like how much time, effort, trial and error it takes for vaccines, medical devices and new procedures to earn the Good Housekeeping Seal of Approval: in this case, the imprimatur of the Food and Drug Administration (FDA). Even if a med. vaccine or device is granted “humanitarian use” status, it’s not going to start changing the world overnight. And for good reason.

In the world of medical research, there are a ton of hoops to jump through before a med, vaccine or device is approved. Welcome to the largely unknown world of medical ethics and Institutional Review Boards. In order to understand what we’re talking about, let’s quickly go back to the so-called “Doctor’s Trial” at Nuremberg. On December 9, 1946, an American military tribunal opened criminal proceedings against twenty-three leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Officially called United States of America v. Karl Brandt et al, the trial was the first of twelve similar proceedings against Nazi doctors held by the United States following World War II. Without getting into too much detail, the trials proved that nearly two-dozen German doctors were responsible for carrying out horrific medical experiments on mostly Jewish “patients” without either their knowledge, much less their consent. As a result of the trials’ findings, a movement began which eventually made it mandatory that anyone participating in clinical trials be protected and have full knowledge of what was about to be done by way of experimentation. And, perhaps most importantly, making it crystal clear that any such participation must be both voluntary and retractable.

Thus was a new world - and a new level of protection - created in order to safeguard the rights of people engaged in medical experimentation.

Over the past 75 years, the world of medical ethics (which a lot of idiots consider to be an oxymoron) has become an integral part of clinical trials - the pursuit of creating new medicines, devices and procedures while keeping an ever watchful eye on the safety of human subjects. Personally, I have been an active member of an Institutional Review Board - the technical name for such panels - for the past quarter century; 18 with the Cleveland Clinic and the past 7 with Advarra, the largest such group in the world. Our board, by law, is made up of MDs in various specialties, pharmacologists, bio-engineers and at least two “civilians” whose responsibility is vetting and translating informed consent documents into understandable English. The latter has long been my specialty. As such, I have been privy to literally thousands of medical protocols, modifications, informed consent forms (ICFs) and continuing review documents.

Through all these years, I have learned an awful lot about the world of medicine. I have seen up close and personal just how much time, effort money and brilliance goes into taking an idea or theory and eventually turning what once was a mere pipe dream into a panacea. A high percentage of the “pipe dreams” will never pass muster; will never get FDA approval and thus become marketable. In order to succeed, “drug X,” “device Y” or “surgical procedure Z” must first go through animal studies, then a minimum of 3 separate “phases,” which first are given or undergone to (or by) healthy human subjects . . . with their full knowledge and retractable consent.

In these “phase 1” studies researchers investigate whether the drug in question is safe. This is accomplished by looking closely at maximum dose tolerability, pharmacokinetics “PK” - a branch of pharmacology which looks at absorption, distribution, metabolism and excretion (ADME), pharmacogenetics “PG” - which is concerned with the effect of genetic factors on reactions to the drug in question, and pharmacodynamics “PD” which investigates how the drug affects the human body. In phase 1 studies, subjects are informed that not only is their participation voluntary, it must not be considered a treatment for any known disease of medical issue.

In “phase 2,” the question for researchers becomes “does the treatment (or drug-in-the-making) work? In phase 2 clinical trials, participants actually have some form of the disease in question. With regards to some phase 2 trials for Covid-19, subjects may have a mild form of the disease or have recovered. Herein, researchers are likely to investigate whether or not the body has developed antibodies which may, in turn, be used to create vaccines. In phase 2 trials, subjects may receive the the same dose amounts, a Single Ascending Dose (SAD), a Multiple Ascending Dose (MAD) or be part of what is called “double-blind, placebo-controlled trial. “Double-blind” means that neither the investigator(s) nor subject(s) know what dose is being administered, or whether the unknown dose is the drug in question or a “dummy” pill or infusion. This is called a “placebo.”

Now on to “phase 3,” in which, generally speaking, these clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know if the new drug is better than the “standard of care” (SOC), subjects are usually randomized to get either the standard treatment or the new treatment.

Under normal circumstances it takes at least a year - and frequently far more - to go from animal studies to phase 3. In the case of Covid-19, things are different; these are by no means “normal circumstances.” There is as yet no “standard of care.” At the moment, there are a minimum of 100 ongoing studies around the world. Many deal with the creation of a full-blown vaccine; some deal exclusively with creating better and more effective test kits; others are investigating things like T-cells found in Covid -19 patients and whether this will bode well for long-term immunity. Biopharma and biotech companies across the globe are approaching the fight against Covid-19 with various weapons—repurposed drugs, antivirals, vaccines and clinical antibodies. This is pure science. The fact that so many agencies within the federal government, university medical laboratories and private corporations are working around the clock is a hopeful sign.

The politics of Covid-19 is something else. In recent weeks, we’ve seen and heard POTUS hawking the use of Hydroxychloroquine and the antibiotic Azithromycin (“Z-Pak”) as a panacea for the treatment and eventual eradication of Covid-19. Besides being totally devoid of any knowledge of things pharmacological, POTUS is causing time, talent and money to be wasted trying to prove that he is correct. Just the other day, the website of the National Institutes of Health informed the public that they were entered a phase 2b clinical trial investigating whether this “cocktail” can be efficacious. This comes on top of POTUS’s recent - and utterly reckless - suggestion that ingesting or infusing bleach into the human body might be effective. Shortly after having the entire medical/scientific community come down on him like the front line of the New England Patriots, he changed his tune and said he was merely being “sarcastic.”

Now comes “Operation Warp Speed.” From what I know about medical ethics and the closely-watched procedures involved in creating new medications, there are precisely two possibilities that Operation Warp Speed will be approved by the FDA and be made available to the public by the end of 2020: absolutely none and less than that. That is unless POTUS forces the NIH, FDA, HHS and a host of other scientific watchdogs to turn a blind eye to medical oversight . . . to turn back the clock to a time just after the “Doctors’ Trials.” This is truly unconscionable, immoral and, to my way of thinking, overtly illegal.

On the bright side, some of the best medical/scientific minds on the planet are working day and night to rein in this ghastly pandemic. From where I sit and the protocols we at Advarra have already been privy to, Covid-19, like the Spanish Flu of 1918/19 (not 1917, as POTUS believes) shall be overcome.

What America and the world needs now, more than ever, are leaders who are acutely aware of what they do not know, and get on with the work of saving the world because of what scientific and medical researchers do know.

פֿון אונדזער מויל צו גאָט ס אויער

(fun undzayr moyel tzu gaht’s aoyer “From our mouth to God’s ear!”)

174 days until the next election.

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categories / Medical Ethics

Proditomania & Other Issues

November 26, 2019 / Kurt F. Stone

For every kind of nuttiness or fear, there is a precise term that fills the bill. Among the more fascinating fears are:

“Who stole my strawberries? And while we’re at it, why is everyone out to get me?”

glossophobia: the fear of speaking in front of an audience (performance anxiety)
aviophobia: the fear of flying
nyctophobia: the fear of nighttime or darkness
coulrophobia: Fear of clowns
scoionophobia: the fear of school
triskaidekaphoobia: the fear of the number thirteen

Looking for a single word meaning “the excessive desire to participate in war?” That would be polemania, which is derived from the Greek “polemo,” meaning “war.” How’s about “Lying or exaggerating to an abnormal extent?” That would be mythomania. Then there’s pseudomania, meaning “an Irrational predilection for lying,” typomania, “a craze for printing one’s lucubrations,” and the title of this week’s essay, proditomania, meaning “the feeling or belief that everyone is out to get you.” Without question, these five manias have all found a home in the mind of our current POTUS. It’s akin to a reverse pathological version of Graft Versus Host Disease, wherein it’s the mind (instead of the body) which immunizes itself against (thus rejecting) a transfusion of otherwise psychologically healthy cells.

For more than 2 years, psychiatrists, psychotherapists and neurobiologists have been analyzing ‘45’s psychological profile without benefit of interviews, clinical sessions or tests; ethically questionable to be sure, but nonetheless understandably ineluctable. In March of this year, a group of 37 prominent analysts published The Dangerous Case of Donald Trump, which provides valuable insights in DJT’s psychosocial pathology. Medical ethics aside, he possesses one of the most worrisome and potentially harmful psychological makeups of anyone who has occupied the office of President. Besides possessing a paranoiac personality, ‘45 likely suffers from “Narcissistic Personality Disorder,” the hallmarks of which include grandiosity, a lack of empathy for other people, and a need for admiration. People with this condition are frequently described as arrogant, self-centered, manipulative, and demanding. They may also have grandiose fantasies and may be convinced that they deserve special treatment.

Of course, ‘45 is not the first - nor undoubtedly the last - to be beset by complex psychological demons. According to a study by Jonathan Davidson of the Duke University Medical Center and colleagues, who reviewed biographical sources for the first 37 presidents (1791-1974), half of those men had been afflicted by mental illness—and 27% met those criteria while in office, something that could have clearly affected their ability to perform their jobs. Among those Davidson cited were:

Abraham Lincoln, who suffered from what used to be called “melancholy” (depression or bi-polarity);
Teddy Roosevelt, who exhibited many of the classic symptoms of both Obsessive-Compulsive Disorder (OCD) and bipolarity.
William Howard Taft, who suffered from sleep apnea, which is associated with declines in cognitive functioning, and most famously,
Ronald Reagan, who showed early signs of Alzheimer’s while still in office.

Of course it should go without saying that anyone who believes they have what it takes to be elected and then serve as POTUS has a larger-than-normal ego. This is definitely not a position for anyone who suffers from an inferiority complex . . . although it is possible that the former (ego-mania) can serve as overcompensation for the latter (inferiority complex). In medical terminology, an overdeveloped ego can be a sequela (a consequence) of deep-seated feelings of inferiority. (Or, as mom has said on more than one occasion: “It’s not that he suffers from an inferiority complex; he’s just plain inferior!”)

‘45’s proditomania – the obsessive belief that everyone is out to get him - is on display in a thousand different ways every day of the week. It is this belief which leads him to accuse any media outlet or personality to be part and parcel of a vast conspiracy which he and his hard-core followers call “Fake News.” It is his proditomaniac worldview - coupled with runaway narcissism - which gives him license to eviscerate and dehumanize the opposition, all the while cloaking himself in a steely veil of virtue. Frequently, 45’s most inexplicable actions (and reactions) bring to mind a line from Butch Cassidy and the Sundance Kid: There are no rules in a knife fight.”

When it comes to ‘45’s credibility, there seems to be 3 unequal camps:

Those who refuse to believe or accept anything he says or claims;
Those who are more than willing to believe or accept anything he says or claims;
Those who no longer care.

I for one am squarely in the first camp . . . which bothers me greatly. For I would greatly prefer to have even a modicum of faith in the POTUS, his administration and those who serve not their party nor their own interests, but rather our country and its Constitution.

I find myself wondering what goes on in Boss Tweet’s mind when he finally lays his head on the pillow at the end of a day. Is he afflicted with own dishonesty . . . his own perfidy and imperfection? Or does he sleep like a baby, secure in the delusion that he is the smartest, most successful and healthiest person to ever occupy the Oval Office? Does he really, truly reach out to Morpheus, the ancient god of sleep and dreams, smiling at the thought of a second, third or even fourth term in office? Or is he tossing and turning, besieged by the pending nightmare of just how he’s going to get himself out of all the mayhem he himself has wrought?

Not quite 2 weeks ago, ‘45 made an unscheduled, unannounced visit to Walter Reed hospital for a medical checkup. Precisely what tests and/or procedures he underwent has yet to be made public. What we do know is that he is not as healthy as he claims: according to his “body mass index” (BMI) he is morbidly obese, exists on a diet largely made up of fast food and so-called “comfort foods,” and takes both a statin (Crestor) and a daily dose of aspirin . . . both of which are to stave off a future heart attack. And then, there are all those pesky psychological issues.

I find myself wondering if in the time it takes to fall asleep (meaning those nights he doesn’t take an Ambien tablet), he is setting in motion a plan to resign his office before the dreck hits the fan. Could it be that the unscheduled visit to Walter Reed was part of the strategy? Is it possible that someday soon he will announce that due to an unforeseen medical issue, he must, upon the advice of his medical team, turn over his office to Vice President Pence? Could this be his way of having to spend the remainder of his time in office facing a trial in the Senate and then losing reelection . . . thus being able to prove that he was, in the end of days, correct: they were out to get him.

Only time will tell . . . although I for one will continue to pray for his health.

342 days until the presidential election

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categories / Medical Ethics

Maria Isabel Bueso, MPS VI, and the Sin of 'Moral Albinism'

September 15, 2019 / Kurt F. Stone

In the world of medicine, albinism (being an albino) refers to any of a number of rare, inherited genetic conditions in which the amount of melanin pigment (that which causes skin to tan in sunlight) is dangerously low. Albinism is characterized by almost dead-white skin and hair and - somewhat erroneously - pink eyes. Baby boomers will likely remember rock guitarists Johnny and Edgar Winter and are certainly familiar with journalist Anderson Cooper, all of whom suffer from the condition.

Maria Isabel Bueso: Amerca’s Most Prominent Victim of Trumpain Moral Ablinism

Thus, to be an albino - medically speaking - means to be without any color or shading. It is - without question - a genetic condition. Let’s posit for the nonce that albinism can extend beyond the body, and the term used to describe and define other kinds of human mutations and failings. What I have in mind is what we might call “moral albinism” - an ethical code utterly devoid of conscience, coloration or nuance, and caused not by an inherited genetic mutation, but rather by intense psychological abnormality - which may or may not be a familial legacy. To my way of thinking ‘45 and most of what passes for his revolving-door, three-ring circus of an administration, suffer from collective moral albinism. Let’s face it: anyone possessing even a scintilla of “moral melanin” would find it difficult - if not morally repugnant to the max - to lend support to white supremacists, neo-Nazis or racists; to find no problem with separating refugee or asylee children from their refugee or asylee parents; or from having little or no problem deporting children with life-threatening medical conditions to countries which are virtually incapable of treating, let alone saving their lives.

At this point we introduce one and all to Maria Isabel Bueso, potentially America’s most prominent victim of Trumpian Moral Albinism. Maria Isabel (called mostly by her middle name, “Isabel”) was born in Guatemala. At age 7, she was diagnosed with MPS-VI, also called “Maroteaux-Lamy Syndrome” and mucopolysaccharidosis type VI, a rare and fatal genetic disorder. Permit me a sentence or two as a medical ethicist who is not unaware of compassionate use studies involving MPS VI. This rare condition involves the deficiency or absence of an enzyme called arylsulfatase B which leads to the accumulation of complex carbohydrates. It can easily cause life-threatening complications including coarse facial features, corneal clouding, joint abnormalities, skeletal malformations, an abnormally enlarged liver and/or spleen, hearing loss and death, generally by age 20. This is the disorder Isabel was diagnosed as having at age 7. Without treatment (which was all but nonexistent in 2002) there was little hope she could live another decade.

In 2002, Dr. Paul Harmatz, a pediatric gastroenterologist who practices at UCSF Benioff Children’s Hospital Oakland, Calif. learned about Isabel and inquired as to her interest in coming to California in order to partake in a clinical trial of a new drug (Naglazyme®), a first-of-its-kind enzyme-replacement therapy that extends patients’ lives by more than a decade, on average. Isabel and her family’s willingness to relocate to support her - and armed with a V-2 Visa, helped make it possible for the trial to move forward. Two years later, Dr. Harmatz’s trial led to FDA approval of Naglazyme. For the past 16 years, Isabel has been receiving 6-hour weekly infusions. Not only that; during these sixteen years she has stabilized, graduated summa cum laude from California State University, East Bay, and made other contributions, including the establishment of a scholarship for students with disabilities. Meanwhile, her family members have forged new careers and new connections in their church and community here in the United States. For the past 16 years Isabel, her family, and tens of dozens of other children having life-threatening diseases and disorders, have continued receiving medical care under a government program that defers action on deportations in order to seek medical treatment.

Then Isabel - and so many other children and families - ran headlong into Trumpian Moral Albinism: the program which permitted them to remain in the United States was about to be discontinued and they all had one month to leave the country or face deportation. For Isabel and the other children - whose participation in these clinical trials has led to major medical breakthroughs - deportation was tantamount to a death sentence. Last week Isabel testified before the House Oversight Committee - alongside Jonathan Sanchez, a young Honduran suffering from Cystic Fibrosis - telling them that being forced out of the United States was signing their death warrants.

For its part, the Trump administration has wavered back and forth as to what indeed they are going to do. First, the administration, in a statement from the United States Citizenship and Immigration Services (USCIS), announced an abrupt end to the program which permits non-citizens seeking medical treatment in the U.S. Then, after Isabel’s congressional testimony brought this sinful, inhumane situation to overall public attention, USCIS backtracked a bit and said they would reexamine Isabel’s deferred action application. As of today (September 15, 2019) no one knows what the outcome will be. The one thing the administration has done is to transfer the entire issue from USCIS to ICE (Immigration and Customs Enforcement), whose mandate has nothing - I repeat NOTHING - to do with these sort of deferrals.

So far, the administration has been absolutely closed-mouth about what motivated them to deny medical attention to some of the most vulnerable people on earth. Trump’s legion of moral albinos have taken to social media and charged that these deathly ill human beings are “milking American taxpayers out of their hard-earned dollars” and that “we should take care of Americans first.” Of course many of those making these kinds of charges steadfastly favor eliminating Obamacare, cutting funding for Medicaid and mental health services and deporting any and all who “take” so much as a dime in government services. Then too, they have no idea that most compassionate use studies are paid for by pharmaceutical companies, philanthropic organizations, the National Institutes for Health or national groups devoted to raising funds for and awareness of various medical conditions, diseases and disorders.

This sinful act of moral albinism - larded over with good old-fashioned stupidity and abject meanness - is, quite likely, the POTUS’s attempt to keep his political base happy . . . to show them how terribly tough he can be when it comes to and all non-citizens. Although I find this strategy far more than detestable, I nonetheless can understand it . . . as a political strategy; do anything and everything to keep your political base happy. Again, this I understand. But what mystifies and sickens me the most is that this base is made up largely of Evangelical Christians - people who carry a Bible in one hand and the sword of puritanical moral judgement in the other. For reasons which totally elude me, they find no inconsistency in decrying the moral degradation of modern society while supporting the least moral president in history; of urging “In God We Trust” signs and the Ten Commandments (which include the words “Thou shalt not bear false witness against thy neighbor” in every classroom all the while cheering on a man who never goes to church, tells a minimum of a dozen lies a day and doesn’t even know that “Corinthians II” is called “Second Corinthians” rather than “Two Corinthians,” His base contains millions of people who can quote Scripture from here to Tristan Da Cuna but conveniently become deaf, dumb and blind when it comes to verses which implore us to clothe the naked, feed the hungry and care for the sick and the strangers amongst us.

I guess that when it comes to choosing between appointing conservative Supreme Court justices, restricting abortion access and LGBT rights, supporting the right to own and carry automatic weapons and turning a blind eye to the sin of moral albinism, the choice is easy.

Let’s pray that one day, someone will engage in a clinical trial for creating a successful method of moral melanin replacement therapy. Goodness knows we need it.

421 days until the next election.

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categories / Medical Ethics, Religion and Politics

Throwing a Monkey Wrench into Medical Research

June 09, 2019 / Kurt F. Stone

This past week, while donning his horrendously-tailored “soup and fish,” dining with the Windsors and about-to-be former British P.M. Teresa May, commemorating the 75th anniversary of the D-Day Landing, playing golf in Ireland and bashing Senate Minority Leader Schumer, Speaker Pelosi and Director Mueller, ’45 somehow managed to find the time to throw a toxic monkey wrench into the future of medical research. ‘45’s announcement that the federal government is changing its policy on the use of human fetal tissue in medical research sent a collective chill up the spines of clinicians and researchers from Maine to California. His announcement - which has been percolating for quite some time - has precious little to do with science and everything to do with partisan politics. It is obviously designed to please the many anti-abortion groups which have strongly supported ‘45, the very man who once proclaimed on “Meet the Press “I am firmly pro-choice in every sense of the term.”

As mentioned a few sentences above, the push for banning the use of human fetal tissue in government-sponsored research has been percolating for the past several years. The level of controversy around fetal tissue research waxes and wanes. Human fetal tissue research has been done in the United States since the 1930s, and NIH has been funding this type of research since the 1950s. There was a ban on such funding, however, during part of the terms of Presidents Ronald Reagan and George H.W. Bush. Federal money was restored with bipartisan support in a 1993 bill for the NIH. Among the backers of that effort were some strong abortion opponents, such as Sen. Strom Thurmond (R-S.C.), who argued that the research could help people — like his daughter — with diabetes.

NIH spent $115 million on human fetal tissue research in 2018, a tiny fraction of the nearly $14 billion it spent on clinical research overall. NIH currently funds roughly 200 projects that use fetal tissue, according to HHS.

Fetal tissue once again became a hot-button issue in 2015 with the release of doctored videos, later discredited, purporting to show Planned Parenthood officials discussing tissue donation policies and reimbursement. Last fall, the Trump administration announced it was conducting a review of all research involving fetal tissue to ensure it was consistent with statutes and regulations governing it.

Under the new policy, employees at the National Institutes of Health (NIH) will no longer conduct research with human fetal tissue obtained from elective abortions, after using up any material they have on hand. Officials also immediately stopped funding a multiyear contract at the University of California-San Francisco using human fetal tissue in mice to research HIV therapies. Federally funded projects at other research institutions using fetal tissue can continue until their grants expire. But renewal for these projects and future proposals will have to go through a newly established ethics review process to receive funding. It’s not clear yet what standards that process will entail or whether such experiments will be able to proceed under government sponsorship.

Additionally, under the new policy, extramural researchers who submit applications that pass scientific review and score high enough to be funded will now encounter a new and time-consuming layer of review. Under a procedure described in a 2006 law that governs NIH policy, HHS will need to announce in the Federal Register that it plans to assemble an ethics advisory board to review each proposed grant and invite public nominations for that board. The board would be made up of 14 to 20 people from various backgrounds, including at least one theologian, one ethicist, one physician, and one attorney. No more than half of the panel members can be scientists. The HHS secretary must wait at least 30 days after the publication to appoint the board. The board will then have up to 150 days to recommend to the secretary whether the proposed research should be funded.

Even then, the Secretary can overrule the committee if he finds its recommendation “arbitrary and capricious.”

(Truth to tell, it has long been the case that every NIH-sponsored clinical trial must be thoroughly vetted and scrutinized by an Institutional Review Board [IRB] which is made up of physicians, scientists, bio-engineers, ethicists and so-called “public members.” I have been an active member of the largest of these boards for nearly 25 years and have easily vetted more than 2,000 research protocols in that period of time. So this is , in reality, nothing new.)

The anti-abortion (“pro-birth”) crowd has somehow convinced its followers that banning medical research which uses human fetal tissue will somehow keep women from obtaining abortions. Where they ever came up with this idea is beyond me. It has about as much logic behind it as enshrining the Volstead Act in our Constitution (about 100 years ago) , proclaiming that it would greatly reduce the number of people imbibing alcohol. What it did do was create a world of bootleggers, murderous gangs, bathtub gin and the likes of Al Capone, Frank Nitti and Eliot Ness.

Many of these same pro-birth advocates claim - in the name of scientific research - that there are “effective options” to using human fetal tissue, including monkey or hamster cells for vaccines as well as blood collected after birth from umbilical cords that are rich in blood-forming stem cells. They also suggest the use of adult stem cells and “organoids” — artificially grown cells that somewhat mimic organs. Another suggestion made to Alex Azar - the former president and chief lobbyist for Eli Lilly and Company and current Secretary of Health and Human Services - was that using tissue from a miscarriage could be an acceptable alternative to using tissue from an aborted fetus because it’s from “a natural death, not an intentional killing of the child.”

Checking with many of my IRB colleagues, they say that the use of adult stem cells and organoids “aren’t close to being ready for prime time. . . they cannot mimic real tissue.” The use of human fetal tissue in medical research holds out the hope for real progress coming up with therapies and even cures for HIV, Parkinson’s Disease, Diabetes and various forms of neurodegenerative disease such as Alzheimers Hunington’s and Lewy Body Dementia.

Considering the Trump family medical history, one would think that ‘45 would be more interested in doing research which might save his sanity - or that of his children and grandchildren in the future - than scoring electoral brownie points with anti-abortion activists in the present. The United States has long been a world leader in medical research. Creating new, potent and safe drugs, devices and procedures is a long and difficult process which requires scientific brilliance, firmly embedded in ethical practices. It also requires an absolute minimum of partisan politics. Diseases, syndromes and impairments are neither Republican nor Democrat, liberal or conservative. They can strike anyone and everyone.

We owe it to future generations to remember this simple truth and let the researchers get back to their labs and clinics and do what they do best.

516 days till the next election.

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categories / Medical Ethics

The Gift That Keeps on Giving

April 01, 2019 / Kurt F. Stone

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.

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categories / Healthcare

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

June 18, 2018 / Kurt F. Stone

Drs.  Vibhav and Sonal Rangarajan and Their daughter, Radha — 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.

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categories / Healthcare, Medical Ethics

The Right to Try: Is It a Lie?

March 20, 2018 / Kurt F. Stone

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 . . .

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categories / Healthcare, Medical Ethics

Channeling William Congreve

September 24, 2017 / Kurt F. Stone

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, f ollow 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.

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categories / Healthcare, All Politics All the Time

Zelig Eshhar: Putting Cancer in the Rear-View Mirror

September 03, 2017 / Kurt F. Stone

(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 . . . ?

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categories / Healthcare, "The Lay Professional"

Ironic? Definitely. Irenic? One Can Always Pray.

June 25, 2017 / Kurt F. Stone

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.

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categories / Healthcare, All Politics All the Time

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