Point of View

Debate or Debacle by Al Sikes

September 30, 2020 by Al Sikes 4 Comments

If something is obvious I note it and move on. Last night’s debate was a debacle.

President Trump specializes in distraction. Last night’s performance was his specialty at work. There are no rotating spotlights in Trump’s world. Rules to the contrary are readily breached.

Inevitably the post-debate commentary noted Joe Biden’s numerous interruptions. A better strategy might have been to just let Trump be Trump. But my intuitive assessment is that if Biden had taken a decorous approach it would have aligned with the low energy criticism and not served him well.

My further thought regards the moderator. I have watched Chris Wallace numerous times and regard him as quite able. Last night was once again proof that the Trump style is disabling.

Finally, if I were representing Biden I would insist on what I call the silent mic rule. If the rules on time allotted or interruption are breached then the mic would be turned off. The rules would mute craziness; the viewers would not have to use their TV mute button.

I am sure political wizards are busy trying to figure out what strategic or tactical approaches will best serve their candidate. Speaking as one member of the audience and electorate, my attitude is simple: do not embarrass the United States a second time.

Al Sikes is the former Chair of the Federal Communications Commission under George H.W. Bush. Al recently published Culture Leads Leaders Follow published by Koehler Books.

A Quick Take on the First Presidential Debate by J.E Dean

September 30, 2020 by J.E. Dean 2 Comments

Presidential debates are intended to educate voters. Debates contrast with campaign rallies, speeches, and even town halls, in that the candidates are supposed to be questioned, side-by-side, to help voters decide for whom to vote. A recent editorial described the debates as the “metaphorical equivalent of a presidential job interview.”

No one would describe Tuesday’s debate as a job interview. If it were, neither candidate might have been hired. The debate was, as advertised, combat between two candidates who don’t like or respect one another. Civility never entered the building on the campus of Case Western University in Cleveland.

The debates are meant to be serious business—name-calling is supposed to be set aside in favor of facts. In theory, the candidate best proving himself as informed, competent, and having policies reflecting the will of the people would win the debate.

Tuesday night’s performance did not surprise anyone familiar with President Trump’s previous debate performances. He was aggressive in his responses to Biden, interrupting Biden’s time, and included ad hominem attacks. If you did not know that Biden spent 47 years in Washington, you did after the debate.

In practice, Presidential debates, like those in the primaries, have been less than lofty. Last night’s event in Cleveland might be characterized as an exception, but not in the right direction. Biden called Trump “a clown” and described him as “the worst President in history.”

President Trump met expectations (at least mine) by attacking Biden’s son, Hunter. He repeated allegations against him relating to both Ukraine as well as receiving $3.5 million from the wife of the mayor of Moscow.

Tapes of the debate won’t be used in high school civics class to teach students “how it is done.”

Despite the tone of the debate, it was worthwhile to watch, even though it is unlikely any votes were changed. While a lot of name-calling occurred, issues were addressed, albeit not in the manner high school debate coaches might consider optimal.

About that later.

First, the moderator. High expectations surrounded Chris Wallace of Fox News. In recent weeks he has been tough on the Trump administration. He is viewed as independent and smart. He lived up to that reputation despite the challenges inherent in a passionate exchange between two candidates who genuinely don’t like each other.

Wallace did his best to limit the mudslinging and to steer candidates back to topics he selected for the debate. He generally failed. At one point, Trump commented that he was not aware he was debating the moderator instead of Biden.

Charitably put, Wallace had trouble moderating the debate. He did a good job considering the hatred in the room.

One pleasant surprise of the evening was that Wallace teed up climate change as a debate topic. It was not on the published agenda.

Neither candidate departed from their established positions on the issue. Trump reiterated the wisdom of his repudiation of the Paris Climate accords and attacked Biden’s support for a Green New Deal.

Biden attempted to dissociate himself from the Green New Deal after Trump’s repeated references to “leftist” and “socialist” plans. He referenced “the Biden Plan” and coherently suggested that it would ultimately produce net economic gains.

It remains to be seen how this claim will play before voters.

As a Marylander, living on the Chesapeake Bay and carefully monitoring how much the river rises after recent torrential rains, I was grateful Wallace raised this issue.

A bit about President Trump. Trump performed better than I had expected, despite his being characterized as “out of control” by some commentators after the debate. He was aggressive, but not in an unexpected way. Anyone who has studied Trump over the last four years, even a little, knew what was coming.

Trump’s debate style is a constant. He views encounters as fights and comes loaded for bear. Biden faced ridicule, accusations about himself and family, and name-calling. All three appeared to be higher priorities for the President than putting forth a plan for the next four years.

That is the perspective of someone who expected the worst from Trump and hoped for a disciplined discussion of issues.

Trump did talk about policy, but it was more in the form of a look back than a look forward. If there is a Trump plan on how to respond to the pandemic or anything else, we did not learn it. Instead, we were told everything was great with the economy until the “Chinese virus” was sent our way. We were also told that he stands for “law and order,” an effort to contrast himself with Biden, who was accused of wanting to defund the police.

In contrast to Trump, Biden appeared to have effectively prepared for the debate. It showed, in good ways and bad. He responded coherently to many questions, abandoning the practice of changing his thoughts mid-sentence. But he also, at times, appeared scripted. One imagines a concise set of talking points being hammered into him during practice sessions.

Biden was at his best when he tuned out President Trump and addressed cameras directly. When he talked to families about how the pandemic impacted them, including a reference to the empty chairs of the 204,000 plus people who have died, it worked.

For many viewers Tuesday night, one crucial element of the debate was whether Biden appeared to be his full 77 years of age. Trump had teed up this issue by suggesting that Biden would need drugs to perform well. Biden triumphed here. While not necessarily performing like a 2019 Hopkins graduate, he was nothing like the often gaffe-prone candidate who participated in the Democratic party debates earlier this year. Score one for Biden.

Will everyone agree with that? His night will not go down in history as remarkable, but it served Biden’s purpose. The “he’s senile” issue that Trump has thus far unsuccessfully attempted to raise was not revived.

How about the issues?

There was little in the discussion of issues that broke new ground for anyone reading newspapers regularly. Trump defended his handling of the pandemic and the resulting economic turmoil. Biden attacked Trump’s performance.

Trump described himself as a champion of law and order; Biden described himself as a champion of racial justice and healing. He effectively fended off attacks that he supported “defunding” police. Trump refused to denounce white supremacists and even encouraged them to “stand back and stand by.”

Biden cried foul on Trump submitting Amy Coney Barrett as a Supreme Court nominee. Trump described her has a great choice and defended his right and those of the Republican-controlled Senate to do so. Biden emphasized major policy shifts likely under a conservative majority Supreme Court and suggested the nominee was outside the mainstream.

Nothing was said on Trump’s Supreme Court nominee worth commenting on.

The discussion of the integrity of the election was a low point of the debate. The arguments of both sides are well known. Democrats want everyone to vote. Trump repeated his fears of widespread voter fraud caused by mail-in voting. When the smoke cleared about the integrity of the election, nobody was wiser. Most likely a few TVs were turned off during this segment.

Okay, who won?

Although certain Spy readers have accused this writer of looking forward to change at 1600 Pennsylvania Avenue, I am not calling a winner. When I discussed the debate with a friend who watched it independently, he suggested America had lost. He said the debate was “dark” and didn’t want to discuss it anymore.

The next presidential debate will take place on October 15 in Miami, Florida. I look forward to it.

J.E. Dean of Oxford is a retired attorney and public affairs consultant. For more than 30 years, he advised clients on federal education and social service policy.

Out and About (Sort of): Another Giant by Howard Freedlander

September 29, 2020 by Howard Freedlander Leave a Comment

Ever since Supreme Court Justice Ruth Bader Ginsburg died 11 days ago at age 87 of pancreatic cancer, I have become engrossed in this legal giant’s life and career. My wife and I watched “On Basis of Sex,” the movie about Ginsburg’s career to remove barriers to equal rights based on a person’s gender. And we also watched the “RBG” documentary, which confirmed for the most part the Hollywood version.

Judge Mary Arabian

Memories then began to flow about one of my mother’s dear friends in Baltimore, Judge Mary Arabian. They were both determined, goal-oriented women.” Judge Mary” was a frequent guest in my parents’ home.

Like Ginsburg, whose father was a bookkeeper, Arabian also rose from modest circumstances as the daughter of an Armenian rug repairer.

Arabian too shattered some traditions. She became the first woman named to the Municipal Court in Baltimore. This judicial setting is akin to today’s District Court. She later was promoted to the Supreme Bench, which is comparable to today’s Circuit Court.

I recall that Arabian, a graduate of the University of Maryland Law School, telling a story about how she could not get a job with a top law firm, being asked rhetorically by a partner at one of these firms: “Mary, what would one of our clients think?” Her application was rejected.

According to the Ginsburg film, the former Supreme Court justice encountered the same reaction after graduating from the Columbia University Law School following two years at the top of her class at Harvard Law School.

Both Ruth Bader Ginsburg and Mary Arabian could only have felt insulted and demeaned by this typical reaction at the time.

Judge Mary eventually got a job at a law firm that included William Donald Schaefer, who eventually became mayor of Baltimore, governor of Maryland and state comptroller.

When Arabian retired from the bench in 1990, some blue-chip law firms in Baltimore invited her to join, if only for her name to be on the letterhead. She declined.

A year after being named to the Supreme Bench, Arabian had to run for election for a 10-year term. Most judges intensely dislike engaging in the often messy political process and possibly hindering their objective judgments. But Judge Mary had the good judgment to seek help from Leah Freedlander, who was well-versed in city politics. Early on, when my mother urged her friend to campaign in the powerful union halls, she resisted, concerned that she might run into people whom she had sentenced. Though I suspect that my equally resolute mother understood Mary’s reasoning, she asked: “Well, Mary, do you want to win?”

Judge Mary reluctantly went along. She knew better to question my mother’s political savvy.

No movies will be made about Judge Mary Arabian, whose rise to judicial prominence happened on a local stage. However, her being named as the first woman on the Municipal Court was rather significant in 1961. I regret that I never asked the judge how she felt about her precedent-setting appointment. I suspect she may have changed the subject.

Circling back to Judge Ginsburg, I must concede that I find disturbing the opinions of some that she should have stepped down as her illnesses increased and worsened. The thinking goes that should she have retired after an illustrious career, President Obama could have named a younger, still liberal justice and avoided the current nomination of a conservative justice and woman who will feel no obligation to side with her predecessor’s opinions.

Why do I find this thinking bothersome? Because I never heard similar retrospectives about aging men who faced medical challenges. Also, had Judge Ginsburg retired for political purposes to give Obama the opportunity to appoint a younger person, she would have placed a political stamp on the Supreme Court. Some may say that already happened after the Bush v. Gore decision in 2000.

Nothing I have read or heard convinces me that Judge Ginsburg was unable mentally or physically to perform her duties as an associate Supreme Court justice despite several bouts with cancer. Her opinions in the majority or in dissent were well-written and well-reasoned, as well as respected by her peers on the nation’s highest court.

Judge Mary Arabian broke the glass ceiling in Baltimore. Judge Ruth Bader Ginsburg helped remove legal barriers as a civil rights attorney, winning five out of six cases before the Supreme Court. Her intellect and character shone brightly on a court once dominated completely by men.

Mary Arabian was a towering figure to me. As was Ruth Bader Ginsburg. Each combined abundant brain power and effective willfulness.

Columnist Howard Freedlander retired in 2011 as Deputy State Treasurer of the State of Maryland. Previously, he was the executive officer of the Maryland National Guard. He also served as community editor for Chesapeake Publishing, lastly at the Queen Anne’s Record-Observer. In retirement, Howard serves on the boards of several non-profits on the Eastern Shore, Annapolis and Philadelphia.

The Tears of Autumn by Jamie Kirkpatrick

September 29, 2020 by Jamie Kirkpatrick 2 Comments

I get this way every year about this time. Don’t get me wrong: I love this season, probably more than any of its other three siblings, but there’s an undeniable nostalgia and sadness to this time of year. Autumn is a poignant leaving, like the death of a beloved friend, or the end of a love affair, or the aches and pains and brittle bones of old age. I should know: I’ve known all these and more. Sigh.

Maybe it’s just the quality of autumnal light. The meager slant of shadow or the quickening darkness. Maybe it’s the early morning chill that sidles up onto the porch to cool my steaming cup of coffee. Maybe it’s the first leaves drifting down to cover our little patch of lawn like fallen soldiers. Then again, maybe it’s that first whiff of sweet woodsmoke, or the burn of that first sip of bedtime whisky, or the clutter and squawk of all those chatterbox geese, tired and hungry after their long flight back to our watery world. Or maybe it’s just a tide of tiny chrysanthemums drifting silently in a black pool on a quiet Sunday afternoon, slow dancing to the music of the spheres.

Or maybe it’s the telltale ticking of our inner clock, the one marking our atavistic instinct about the days to come, days when we’ll hunker down to wait out the long, frigid nights under a pile of blankets, snug in our beds, dreaming of spring’s return.

Despite all the sturm und drang of this quarrelsome year, the world keeps spinning its way through space, heedless of all the problems we’ve created since we were last at this point on our heavenly journey: a pandemic, a divided government and an ugly election, the diminution of science to a black art, the turmoil of racial and social injustice, wildfires, hurricanes and tropical storms, droughts—the indisputable tracks of our changing climate. I don’t know about you but sometimes it all just feels so overwhelming to me.

So what’s the answer? My Pollyanna nature is at an impasse. Retreat—running away— doesn’t seem to be an option because the stakes are too high and the world is too small. Denial doesn’t work either because the realities are all too real. A wait-and-see approach sounds every bit as ominous as that bell I’ve heard tolling from the White House recently. You know the one I mean; the one tolling for our democracy, the one that tolls for all of us.

So here’s what I’ve decided to do: sure, I’ll vote but that’s just the beginning because the tears of autumn won’t end when we wake up on the morning of November fourth. No matter who wins, many will lose and much healing work will need to be done, work requiring great and patient effort. I’m not sure I’ll have what it takes, but I’ll do what I can. In the meantime, maybe I’ll exercise more and eat less. Maybe I’ll practice my short game, play my pipes, finish my novel. I’ll sweep the porch, make my bed. I’ll try and do “all politics is local” one better; I’ll make my politics personal. That might sound like a paltry mantra for a guy in his own autumn, but it’s the best I can do.

I’ll be right back.

Jamie Kirkpatrick is a writer and photographer who lives in Chestertown. His work has appeared in the Washington Post, the Baltimore Sun, the Philadelphia Inquirer, the Pittsburgh Post-Gazette, the Washington College Alumni Magazine, and American Cowboy Magazine.
Two collections of his essays (“Musing Right Along” and “I’ll Be Right Back”) are available on Amazon. Jamie’s website is www.musingjamie.com

Snapshots of Daily Life: Fungi by George Merrill

September 27, 2020 by George R. Merrill Leave a Comment

Transformations occur daily. I see some from the corner of my eye.

Since I have an unruly attention span, like a child or a dog’s, my thoughts are easily diverted by whatever catches my eye at the moment. Some peripheral object I catch from the corner of my eye will suddenly command my attention and arouse my curiosity. Immediately my mind begins working backwards from the fragment itself and starts wondering about the source from which it came.

And so recently, from the corner of my eye, I saw fungi formed next to our porch stairs. They grew on the stump of a fallen birch tree. They made a lovely formation. My reaction was quite contrary to the feeling I’ve generally held about molds and fungi, namely, that they’re yukky.

I wanted to photograph the formation ––black and white, of course–– but it was situated in such a way as to make camera access very difficult. I nevertheless attempted it. It turned out to be a production to get positioned for getting a good image –– while my arthritic back protested –– but finally I did. I thought the formation of the fungus, enthralling. A picture of it accompanies this essay.

A fungus, among other things, is a visible witness to the ecological phenomena of organic decomposition. I like to think about it as yet another manifestation of transformation that is as fundamental a process to our spirituality as it is of organic life. Transformation is the way of the world.

Transformation is also at the heart of hope. Hope is about sitting quietly with an intimation that we are becoming but just what, we’re not really sure. Generally, our hope is that whatever may happen, when we get there, all will be well. Just what we are becoming is never clear except for some happy souls who are sure of what’s going to happen next. To them I can only say how Buddhists would offer the thought that they are indulging illusions, fragments of imagination that are best not taken seriously.

We live, today, in a black and white world; psychologists and philosophers call it ‘dualistic.’ Politics is one example; its soundbites are framed to have us believe things are either this way or that. I think this is grossly misleading. Things vary far too much in life to assume that we can nail anything down for sure. Being uncertain, however is an anxious feeling. Having opinions is reassuring and can offer us comfort by assuring ourselves that we know what in fact is unknowable. I’ve noticed that those who suffer this uncertainty acutely, are the most strident in the expression of their opinions.

One reason we can never know what’s next is the way time works. Time transforms everything big and small. Time has ways of exalting the humble and humbling the exalted or to say it differently, messing up the best plans we ever made or redeeming out grossest snafus we’ve committed. In that regard I’m fond of the old story of Joe Jacobs, a humble man and a professional fight manager. One night in 1932, Jacobs, upon hearing that his man lost the decision, seized the mic and shouted. “We was robbed.’ I would have imagined his grammatical error would have consigned his declaration to oblivion. Instead it earned him literary immortality. You never know just how things will play out over time.

The downed birch tree where I saw this lovely fungus is another instance of the unexpected transformations that can surprise and may offer significant comfort. The birch tree was a beauty. It grew close to the house and for over fifty years offered shade for the porch. Birches like this are more common to northern climes so I was often amazed and especially pleased that it fared so well here in the mid-Atlantic.

The time came when the tree began ailing. Leaves turned brown, limb by limb. Was it dying? We consulted an arborist the way patients anxiously turn to doctors with their complaints, fearing the worst but hoping for the best. There was nothing he could do. Saddened, we postponed the inevitable until we finally had it cut down. When it was gone I felt as if I had lost a limb. Only the stump remained, like a grave marker, inches above the ground and close to the house, as I’ve seen in some family cemeteries around old farm houses in rural areas here on the Shore.

It was two years later when I noticed the fungus for the first time.

Seeing beauty in the formation of the fungus softened the harder edges of my mourning in ways I would never have suspected. I don’t know if I shall ever completely get over the fact that the tree is gone from my life but I have found some pleasure in the beauty of the transformational process that had been effected on the root stump. A new life of a very different kind had appeared in this transformation. It appeared wholly unexpected and I saw it first from the corner of my eye.

Columnist George Merrill is an Episcopal Church priest and pastoral psychotherapist. A writer and photographer, he’s authored two books on spirituality: Reflections: Psychological and Spiritual Images of the Heart and The Bay of the Mother of God: A Yankee Discovers the Chesapeake Bay. He is a native New Yorker, previously directing counseling services in Hartford, Connecticut, and in Baltimore. George’s essays, some award winning, have appeared in regional magazines and are broadcast twice monthly on Delmarva Public Radio.

Will The Weeks Ahead Re-elect Donald Trump? By Al Sikes

September 27, 2020 by Al Sikes 5 Comments

The headline was bold, Justice Ruth Bader Ginsburg, who died a week ago, has become the first woman in US history to lie in state at the US Capitol in Washington DC. Ruth Bader Ginsburg broke another glass ceiling. It should have come much sooner.

Beginning next week another woman will enter the spotlight; her name, Amy Coney Barrett. Already much has been written about her so I will not add to her biographical profile.

I will begin by recalling Senator Diane Feinstein’s descriptive phrase: “The dogma lives loudly with you.” This was Senator Feinstein’s conclusion about Judge Amy Barrett Coney’s Christian faith voiced during her earlier confirmation hearing to become a United States Circuit Court of Appeals judge. When the confirmation vote came up, Feinstein voted no.

What in most circumstances would be praise, was in the Senator’s eyes disqualifying. How could a person, influenced in part by the life of Jesus Christ, be for that reason, rejected?

We are all informed by something or some things—family, school, church, experiences, influential friends and more. Is being informed by faith in God disabling? And when it comes to faith, is hypocrisy preferred? There are certainly plenty of persons who loudly proclaim their faith, but when their avowed precepts clash with pleasure or greed or power are quick to embrace the latter.

This is the circumstance, but there is a broader story. Unfortunately for former Vice President Joe Biden his future is imperiled by the broader story.

It seems certain that Judge Barrett will be attacked because of her faith. It will be said she “will vote to overrule Roe v Wade.” On that subject she has voiced approvingly the doctrine of stare decisis. “Stare decisis is Latin for “to stand by things decided.” In short, it is the doctrine of precedent.”

Appropriately, Senators will probe and probe to find any real or perceived departures from this principle in everything Judge Barrett has said or written. But the broader story is about who will be elected President on November 3rd.

Handicappers in recent days have concluded that Joe Biden has over a 75% chance of winning. If I was a handicapper, the probability would be dropping. And it would be dropping because the chances are quite good that persons and organizations aligned with his candidacy will spend the next several weeks trying to destroy Judge Barrett and the chances of her confirmation. She will be caricatured as a feverish zealot who will tromp on the separation of Church and State. Her husband should begin conversations with their seven children on the underlying motivation—power and its corruption.

Notwithstanding what has been concluded in a variety of media reports, I know a number of persons of faith who are not intending to vote for Donald Trump because of his character. That is real news. Now to the speculation.

If Biden advocates choose to condemn Judge Barrett based on her devoutness, attitudes will change. A not inconsequential number of persons of faith inclined to vote for Joe Biden will reverse course. It will not be because they suddenly like Trump, but because an America that leaves no room for authentic faith is to them a higher risk than four more years.

Al Sikes is the former Chair of the Federal Communications Commission under George H.W. Bush. Al recently published Culture Leads Leaders Follow published by Koehler Books.

Op-Ed: Please Say it Ain’t So; A look at Andy Harris’ Recent Activity by Pamela Getson

September 25, 2020 by Opinion 5 Comments

Good citizenship requires we all take a careful look at who we want to represent us. An election is fast approaching. Let’s do that…and quickly.

Among the astounding recent coverage of clearly planned active dismantling of our election by over-riding legal votes and appointing new state electoral members in swing states who will be installed to only vote for Trump, are attempts and actual successes in rewriting guidance of the CDC and FDA. Andy’s name appeared again in a recent short Star Democrat article and he was interviewed by The Spy Wednesday as pre-election coverage later also offered to his opponent. Flip- flop and spin abounded.

Andy Harris is taunting all of us in District 1 and even the entire US. He and two of his longtime friends now comprise a recently formed Data Safety Monitoring Board (DSMB) for an experimental COVID-19 drug trial. Not a vaccine, thank goodness, or at least not yet. But more on that later. It so happens that the drug CEO sponsor is also their friend. This is entirely irregular. An elected official has never placed him or herself in such a role. Not even once. Being a clinician has nothing to do with this and there are many, many boarded critical care/ICU physicians who could fill the committee role. So too, biostatisticians. Real ones. In true form of the new Republican Party, this is a simple bold abuse by Harris of his elected position. He is counting on you to view it otherwise. A little information can help you decide.

A DSMB is meant to operate in complete separation from both the sponsor of a new product, as well as the FDA from whom– if all goes well- they will seek a license for market approval and use. The DSMB is in the middle as they deliberate. Their evaluations are meant to be held in complete privacy from the sponsor and the regulating Agency. When there is an adverse event among the trial patients, it is the DSMB that reviews the data and evaluates risk of the proposed drug if widely deployed. They determine safety of the human trial participants as the trial accrues, as well as evaluate trial progress towards its stated IND protocol efficacy goals. However, under emergency use review (EUA) there is a bit of difference from a full license review: i.e. the members get to decide if observed benefits outweigh risks, and sometimes parse this for subsets of users if a large enough trial has been designed, not that there are not risks.

Each DSMB is intended to have one biostatistician and additional MD clinical members, typically each of them an expert in a clinical area relating to the product. In this case, in addition to no MD member being an infectious disease expert or pulmonologist, or intensive care expert (albeit there is crossover for some but not all anesthesiologist boards), there is also, and importantly, no biostatistician. No one on this very small DSMB has actual credentials which indicate they could calculate a required sample size for a rule they will support, determine an error margin or use sequential analysis to construct a mathematical boundary for stopping rules of safety or futility if their lives depended on it…. but yours and mine just might.

And don’t forget the lives of the people who will first be enrolled in these trials. More on that too because in addition to a very small, randomized trial with patient consent for the drug under review by this DSMB, there is a less obvious ongoing one for expanded use when circumstance will most likely delimit any truly informed consent under critically exigent conditions. Luckily having been used for years in the EU for erectile dysfunction, the drug probably won’t cause serious harm if patients are very closely monitored, nor perhaps ever get licensed for its new putative indication, but that is definitely not the point.

Back to facts. This Board lacks independence as well as the usual requisite skills. Andy should never have accepted or possibly even promoted his own membership on it. He brushes aside recent Politico criticism saying: “they don’t like Republicans.” A laughably easy excuse, but in this case, Politico surely has a point! He was dismissive of its contents, but there’s much more to know. You may want to pause here and read this short article before proceeding.

Andy Harris’ membership on any DSMB is a complete travesty as a show of gray ethics. It does not matter that he is “donating” his service (one wonders what that might actually consist of).No elected Congressman or Senator has ever tried to play such a role and never so boldly as to do so while also being a sitting member on a congressional subcommittee which has budget approval for aspects of the FDA! And just how did his CEO friend bring this 50 year essentially dormant product with only animal and in vitro evidence for this newer indication back to life as a listing in the FDA CoronaVirus Technology Accelerator Program? That’s a good question begging investigation of Harris’ subcommittee work for another day. But the drug also has expanded access, has changed its trial primary endpoint just recently after an early ‘look’ at the data (which has sample size and statistical ramifications that I hope the FDA reviewers will later evaluate), and could actually be utilized with no consent in certain situations. I hope this does not happen to you or me…because in one write-up the drug sponsor states it has already been previously used in “certain ICUs where it was felt to have benefit”. Previously used? Where? With consent? Whose? “Felt” to have benefit? Improperly tested hydroxychloroquine comes similarly immediately to mind, or convalescent plasma which had an encouraging sound, or zinc and all manner of other hopeful elixirs for COVID-19 disease.

But let’s examine the fact that Harris does not have the credentialed expertise needed to play the biostatistician that he claims as his dual role on the committee. How do I know? In addition to actually being one and having participated in domestic and international DSMBs which have always REQUIRED one fully credentialed biostatistician, designed, taught and analyzed 100s of clinical trials, actually have regulated biologic products via carefully vetted re-analyses of sponsor-provided trial data when employed by the FDA, Andy himself has told us so.

Years after his MD training, he enrolled in a shortened program designed for MDs to enhance their business skills of health and healthcare and remarks that he has been involved in papers that contained statistics. That’s it. He entered a program with coursework that was not in-depth statistics nor biostatistics and trial design, much less trial analysis. Of course it included business and investment models in medicine, and coursework centered on program goals of health policy and health finance and management. This was the MHS program – not to be confused with a substantially quantitative track of the longer MPH program, and certainly not that of a PhD, ScD or DrPH. Grants and articles mentioned, with appended authorships, are likewise no simple proof of his own quantitative expertise and applications. Nor just enrolling patients (“being involved in”) clinical trials along the way or appearing at an IRB (institutional review board). Andy is a part-time MD. Let’s leave it at that.

But serving with only two other members, one also without DSMB experience, and one a biologist, and having long personal relationships with not only both of them but also the CEO of the product now re-named RLF-100, which was first registered in the EU as aviptadil for ED, should give one pause. Not because it might not help less severely affected COVID-19 patients suffering due to putative ACE-2 downregulation (though some pulmonologists debate this mechanism), but rather because for some reason it never received license approval in the US for the first indication, either.

Rewriting and overriding guidance for EUA, Emergency Use Authorization, is also chilling. That is because these fast track submissions now fall first under EUA. Without adequate expertise on their own, one can imagine that these three members will simply flip through the pages offered by LavinConsulting, LLC- the registered outside, contract research organization (CRO) who has worked for this drug sponsor in the past, and go on their merry way pushing things forward if the CRO report so suggests.

The CEO drug sponsor himself even seems to agree, having been quoted as saying this DSMB “really doesn’t have much to do”. When the health and safety of human beings is at stake, there should at least be an appearance of much to do. Clearly someone else is handing the detailed and otherwise time-consuming analyses and assessments that are apparently just to be passed along as conclusions of the DSMB. Even so, the DSMB needs to have the expertise to carefully review the generated pages, find any errors, obfuscations and/or exaggerations made by the drug company, and carefully evaluate the provided data and analyses. It is, however, very interesting that the CEO seems to already know or expect little committee oversight, and feels confident enough to state it publically. I suppose that’s just a typical way to energize investors and venture capitalists, but I find it chilling if true. And Andy is meanwhile also our Congressman.

So why is Harris even doing this?

Does he really think the people in his district, ours, will believe it is only because he is trying to help the pandemic situation and not just his friend’s drug review and later marketing and investment efforts? How exactly did they get fast track review status? It’s time to learn more. For now, we know Harris has disabused mask wearing and closure or stay-at-home orders as nonsense or over-reach, calling it a “cult of masks”. He then walked that back in a mumbled statement about what he really meant–how masks might have caused complacency as singular efforts. It is not as if he earlier supported them. And he fought to open Maryland business and allow congregating more widely while case counts of those specific weeks increased in Dorchester County and then regionally. But in his interview with The Spy he also pushed the ideas again, incorrectly saying counts and the epidemic were abating and saying churches were singled out. As if church services, choirs, rally rants aren’t proven super-spreader events. Every talking point a spin version of his earlier days, except retaining his wishes to commemorate the Confederate States of America by leaving the Talbot Boys statuary on public courthouse property.

And then of course a list of his other congressional votes: repeal (without a shred of documented replacement value) the ACA and effectively eliminate pre-existing condition coverage, do not expand Medicaid that would have saved Maryland huge healthcare dollars, keep government in extended lockdown the last year, be an active member of the Freedom Caucus, support coal while defending removal of clean air and water regulations, demean the State Dept abroad, instead vote to waste available appropriations to build the ridiculous, never-to-be-finished Wall …. perhaps his version of immigration ‘reform’.

And he calls himself a physician? Do no harm?

So far we know we have a climate and healthcare opponent, a COVID-19 mitigation denier now entering a last push for back-walking spin, and a non-biostatistician meeting the needs of his friends per a hopeful money-making drug, all while being our elected Congressman. How and why and to what end he has inserted himself into the approval process for our regulated drugs and therapeutics and perhaps even FDA oversight and appropriations per his congressional committees, deserves investigation.

Talbot County wisely did not support him last go ’round and it is time to enlighten the rest of our District. Harris has even rudely and boldly claimed he does not have to worry much about winning or campaigning for this election given his opponent’s newer entry and her smaller campaign war chest. His purported help for watermen and agriculture has been too little, too late to make any real difference; it’s not just about a few belatedly acquired special work visas, his support of changes to trade agreements could have hurt. His constituents absolutely DO deserve his close attention and congressional assistance….all of them!

Now he plans to provide window dressing for Trump in Denton this weekend and get his name and a photo in some media just ahead of the next election. They’ll certainly make quite a performance duo. Harris is an embarrassment. Skip the rally lies and unhinged delusionary content delivered as rousing superficial chants to energize a real cult. Get to the polls or an official dropbox early; use the mail only if you must. We need a true representative, one whose primary concern is our interests and needs, not those of his political party, the current President, his friends, or himself.

Pamela Getson is a PhD biostatistician and former Director of the Statistical Core Group of Children’s Hospital while on Faculty at the George Washington University School of Medicine/Pediatrics. In addition to teaching and research, she designed and evaluated clinical trials, and later served as a senior math/biostat reviewer of data submitted in support of new biologic vaccines at the FDA/CBER. Now living on the shore permanently, she has resumed her love of sailing and nature.

Confusing the Person and the Position by Angela Rieck

September 24, 2020 by Angela Rieck 5 Comments

Most of my liberal and moderate friends disagree with my perspective on this issue. This is good, if we didn’t have disagreement, we would all be in lockstep.

I am impressed with conservatives, e.g., George Will, David Brooks, Mitt Romney, Lincoln Project who are choosing principles over the current leader, by recognizing that he has betrayed conservative principles and values. Their willingness to remain true to their principles is what we are currently lacking in the legislative branch (on both sides).

One person, who sadly confused the person with the principle/position, was Ruth Bader Ginsburg. Although she had a long and illustrious history of supporting equal rights with measured intellect and tenacity; her unwillingness to recognize this talent in others has led to our current crisis.

By believing that hers was the only voice for women and equal rights, and refusing to retire when she was ill and another person who held her same cherished values could be appointed; she may have ironically cost this court a crucial vote for equal rights.

I experienced this in a minor way when I was President of the Board of Education in the Morris School District. Being the President of the School District can be a bit heady, I was recognized with deference throughout the community. I led the Board which appointed employees, had fiduciary responsibility for a $100M budget, oversaw school capital projects, spoke to the press, etc.

Fortunately, I understood that it was the position that was giving me this power not me.

I learned that from my predecessor who had been unable to give up the position. She believed that the school could not function without her. Thereupon she tried to undermine my role, from meetings with the Superintendent to setting the Board agenda.

I had been elected because the Board wanted change. It had devolved into factions and meetings lasted until 11 p.m. to 2 a.m. as the Board argued and argued. My goal was to eliminate these factions, I began by appointing my detractors to key leadership positions.

The previous Board President attempted to undermine me and the board by leading through the Superintendent. After giving her some time to relinquish her role, I had to exercise my elected power during a meeting and ask the Board to vote down the agenda that she and the Superintendent had inserted and not the one that the Superintendent and I had developed.

The Superintendent and I subsequently had another difficult conversation where I made it clear that the Board had elected me and it was I who had the authority and responsibility to work with him, and guide the Board and the School District. He got it and the former President no longer had the right to usurp my position.

After my term, and the next President was elected (a year before she would serve); I included her in every conversation, every phone call, every meeting with the press; so that she, the Superintendent and the Board were ready to accept her leadership. It worked flawlessly, by the time she took over, the factions were eliminated, and most meetings ended by 8 p.m.

The previous President had confused the position with the person. She thought that she was so critical that no one could replace her. But she could be replaced, just as I was replaced, and everyone after me was replaced.

Ruth Bader Ginsburg had an impressive record of accomplishments in women’s and civil rights. But unfortunately, her unwillingness to recognize anyone else’s talents may define her legacy as a person who thought that she was more important than her principles.

Angela Rieck, a Caroline County native, received her PhD in Mathematical Psychology from the University of Maryland and worked as a scientist at Bell Labs, and other high-tech companies in New Jersey before retiring as a corporate executive. Angela and her dogs divide their time between St Michaels and Key West Florida. Her daughter lives and works in New York City.

Doing What’s Right by Craig Fuller

September 23, 2020 by Craig Fuller 1 Comment

There was a morning during a meeting of President Ronald Reagan’s cabinet when a senior White House assistant for political affairs asked to be recognized. When his turn came to speak about the policy question before the President, the aide began to explain the political consequences of making a decision on the subject. President Reagan let him speak his mind and then politely thanked him before saying, “Well, I think we’ll just figure out what the right thing to do is and let the politics take care of itself.”

When it comes to the awesome responsibility of nominating and confirming the next United States Supreme Court Justice, that notion speaks volumes.

My view, politically correct or otherwise, is that we elect a President for a four-year term. We don’t suggest to that individual that we really only want them to make important decisions for 3 ½ years of the term. Thus, the President has an obligation to consider candidates and to nominate a qualified individual for the Supreme Court when there is a vacancy. Politics, elections, pandemics really should not deter a President in doing what is right.

Then, members of the United States Senate should do, however they may individually determine it, what’s right. Each Senator has the right to judge if the qualifications of the nominee are sufficient to confirm the nominee. Their ultimate vote in favor or in opposition of a nominee should be based on qualifications. Of course, the reason behind a vote is up to the individual Senator.

The right thing to do is to allow the process to go forward.

But, the politics are, in my view, not what many may believe.

Should President Trump nominate an individual and see that person confirmed by the Senate before the election, he may actually cause himself and Senate Republicans in close races political harm.

Here’s why…

The process of nominating and confirming a new justice to the Supreme Court is not likely to change the views of voters already firmly decided for whom they will vote.

However, there are among Republican voters a number who hesitate about reelecting Donald Trump, yet they fear a shift in the balance of the Supreme Court during a Biden administration. Providing Trump with one final appointment to the Supreme Court would reduce the anxiety among these voters should they determine to crossover and vote for a change in the White House.

Conversely, should the President and the Senate place one more conservative justice on the Supreme Court, Democratic voters, not already firmly committed, would certainly be more likely to engage in the election process to vote for a President who would select justices more in line with their thinking in the future.

And, there is one additional reason for a moderate voter to favor at least a nomination. While it is possible a Trump victory would cause him to pull back a nomination to the Supreme Court who is not yet confirmed, it is unlikely. And, a Trump nomination coming after the election where no constraint of an election is a factor would not likely yield the same type of nominee.

I think President Obama was right to place an individual before the Senate as a nominee to the Supreme Court nine months before an election. I believe the same is true for President Trump even this close to the election. What the 100 members of the United States Senate decide to do and when they decide to do it is anyone’s guess.

In all of this there is one very important reminder, elections matter. In fact, three of the central actors in the drama that will play out in the weeks ahead are up for reelection: President Trump; Senate Majority Leader Mitch McConnell; and, Senate Judiciary Committee Chairman Lindsey Graham. Let’s hope they figure out what is the right thing to do and then they can let the politics take care of itself.

One more thing…VOTE! It is the single best way to express yourself on this and so many other issues.

Craig Fuller served four years in the White House as assistant to President Reagan for Cabinet Affairs, followed by four years as chief of staff to Vice President George H.W. Bush. Having been engaged in five presidential campaigns and run public affairs firms and associations in Washington, D.C., he now resides on the Eastern Shore.

Editor’s note: Listen to this topic discussed by Al From and Craig Fuller during From & Fuller on Thursday in the Spy

Out and About (Sort of): Denting Digital Divide by Howard Freedlander

September 22, 2020 by Howard Freedlander Leave a Comment

In mid-June I came late to the realization that the inequality represented by the phrase “digital divide” applied to Talbot County as well as it does to counties and cities throughout our country. Fortunately, I could join others to address the problem.

For full disclosure, I am a member of the Talbot County Public School Education Foundation’s (TCPSEF) advisory board. This group went to work when we learned from Superintendent Kelly Griffith that roughly 300 families could not afford internet connection fees.

Covid-19 showcased the economic distress experienced by families forced to provide at-home online schooling for their children. Hundreds of students were hard-pressed to participate. Public school education became inaccessible to many.

The education foundation understood the urgency to ensure that families in need were not shut out from virtual schooling. It set a goal of $60,000 to provide critical educational opportunity during a crippling health crisis when access to in-person school was severely limited.

As of last week, the hitherto unknown education foundation had raised $90,000 from 268 individuals, businesses and private foundations. The community response was astounding, centered around an easily understood need.

For years I read or heard about the nationwide “digital divide” crisis. Through ignorance or naïveté, or both, I never thought that Talbot County encompassed the same inequality that existed in urban areas. I was dead wrong.

Poverty, with its disabling socio-economic consequences, afflicts every corner of our nation, regardless of the wealth that is abundantly apparent in our county. It cannot be ignored.

I watched admiringly as members of our advisory board vigorously sought donations from friends, neighbors, family members and local businesses. The response, as noted, was just incredible, if not heartwarming

Donations ranged from $10 to $7,000. Normally I would scoff at small contributions, wondering how in the world would we reach our goal. Not this time. I was overwhelmingly impressed by the grassroots foundation of this 2-1/2-month campaign.

Much has been written about the inequality in health care, jobs, social justice and education revealed during a pandemic that has removed any doubt about the alarming lack of equity in our nation.

I believe, however, that one silver lining in this crisis has been the pervasive role of philanthropy. Those who can, have stepped forward, not only to support their favorite non-profits, but have parlayed their generosity to human services causes. I’ve seen it repeatedly in our community.

“Digital Divide” obviously carries more heft than simply being a nice-sounding alliterative phrase. It speaks succinctly to a serious chasm in our technology-driven country. Academic and professional success depends heavily on internet literacy.

When an invisible but harmful wall stands between children learning math, reading, science and foreign languages, then our nation suffers dearly from unequal learning opportunities. We who can should pitch in to close the gap, if possible.

That’s what the Talbot County Public School System, working with local providers like Easton Utilities, Delmarva Wi-Fi, Verizon and Atlantic Broadband, has done with an immediate sense of urgency for the fall semester and beyond. The foundation raised private funds to complement government grants.

The problem will remain unsolved until all families in need of financial and technological support have an internet connection—when no school-age child falls behind due to lack of access to virtual learning While a potential Covid vaccine could reopen America to life as we knew it, repair of educational inequality must remain a priority.

Our community deserves commendation, as does the education foundation and its advisory board. Upcoming stories of families and students connected to online teaching will convince donors and educators alike that the Digital Divide campaign reaped invaluable dividends.

Columnist Howard Freedlander retired in 2011 as Deputy State Treasurer of the State of Maryland. Previously, he was the executive officer of the Maryland National Guard. He also served as community editor for Chesapeake Publishing, lastly at the Queen Anne’s Record-Observer. In retirement, Howard serves on the boards of several non-profits on the Eastern Shore, Annapolis and Philadelphia.

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