#991: Contraception and the Future of Medical Research

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

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

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

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

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

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

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

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

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

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

Copyright©2024 Kurt Franklin Stone

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

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). 

         Paul Alexander, Esq. (1946-2024))

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.

     Paul Alexander, Attorney-at-Law

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’!

Copyright©2024 Kurt Franklin Stone               

#945: The Long Goodbye

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.

Copyright©2023 Kurt Franklin Stone

#933: "A Toad Under the Harrow"

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

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

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

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

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

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

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

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

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

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

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

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

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

                Judge Matthew Kacsmaryk (1977- )

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

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

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

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

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

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

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

Copyright©2023 Kurt F. Stone

Are Medical Ethics an Oxymoron?

              Hippocrates (460-370 B.C .E.)

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 . . .

Copyright©2022 Kurt F. Stone

Replacement Theory: Eugenics Refitted in 21st Century Rags

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!!!”

Copyright©2022 Kurt F. Stone

From Your Mouth to God's Ear

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.

Copyright©2020 Kurt F. Stone

Proditomania & Other Issues

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:

1. Those who refuse to believe or accept anything he says or claims;

2. Those who are more than willing to believe or accept anything he says or claims;

3. 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

Copyright©2019 Kurt F. Stone

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

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.

Copyright©2019 Kurt F. Stone

Throwing a Monkey Wrench into Medical Research

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.

Copyright©2019 Kurt F. Stone

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

                              Drs.  Vibhav and Sonal Rangarajan and Their daughter, Radha

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

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

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

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

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

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

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

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

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

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

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

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

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

Find you voice!

516 days down, 957 days to go.

Copyright©2018 Kurt F. Stone

The Right to Try: Is It a Lie?

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

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

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

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

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

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

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

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

Copyright©2018 Kurt F. Stone