Author, Lecturer, Ethicist

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The Gift That Keeps on Giving

The Gift That Keeps on Giving

The Gift That Keeps on Giving

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

583 days until the next election.

Copyright©2019 Kurt F. Stone


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

                              Drs.  Vibhav and Sonal Rangarajan and Their daughter, Radha

                              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?

Right-to-try.jpg

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

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

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

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

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

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

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

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

Copyright©2018 Kurt F. Stone

 

 

Channeling William Congreve

                  Wm. Congreve (1670-1729)

                  Wm. Congreve (1670-1729)

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

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

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

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

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

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

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

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

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

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

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

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

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

247 days down, 1,193 to go.

Copyright©2017 Kurt F Stone

                                                                               

 

 

Zelig Eshhar: Putting Cancer in the Rear-View Mirror

                        Professor Zelig Eshhar

                        Professor Zelig Eshhar

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

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

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

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

 

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

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

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

Currently, the biggest sellers are:

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

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

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

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

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

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

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

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

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

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

Copyright©2017 Kurt F. Stone

Ironic? Definitely. Irenic? One Can Always Pray.

                               Rep. Steve Scalise (R-LA)

                               Rep. Steve Scalise (R-LA)

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

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

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

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

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

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

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

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

How ironic.

156 days gone, 1,301 to go.

Copyright©2017 Kurt F. Stone