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The Coronavirus signals need for reform of U.S. policies for approval of vaccines and advanced cures

I sent a message similar to this essay to Robyn Dixon, author of an article on Russian science and vaccine development in the Washington Post yesterday, February 9. 2021. The Dixon article cited scientist and journalist, Irina Yakutenko, saying that “you should do everything according to the protocols. It takes a long, long time. It takes a lot of money”. That has been true for U.S. policies that have required ten years to release new vaccines*. But the “miraculous” speed of vaccine development in 2020 tells us that those medical policies are grievously outdated and need to change. I copied this message to Senators Tim Kaine and Mark Warner, encouraging them to explore reforms with Senate colleagues and NIH Director Francis Collins. Republicans would likely agree about the importance of reform.

The length of time needed for vaccine development is due to the extreme rigor of U.S requirements for them and other critical cures. This in turn is attributable to concern to minimize adverse effects. The positive potential of a new vaccine can be confirmed in a dozen cases, but to rule out 1:1000 adverse effects may require years and trials with 6000 persons. The FDA operates in the world’s most litigious nation and is risk-averse. We saw what happened in 2020 when excess cautions were swept aside because of the emergency created by the coronavirus. The speed of the approval was startling for our system, but other nations produced vaccines in the same time frame. Sixty-three coronavirus vaccines have been reported in clinical development. Because of the U.S.’s overwhelming dominance in research funding and the rigor and reputation of the National Institute of Health, the sponsor of federally supported trials, our protocols are widely adopted in Germany and other EU nations.

A new vaccine can cost $500 million to $2 billion. This leads to exorbitant treatment costs and a lack of attention to rarer diseases that could be cured. An example is my wife, Lucy, who has a rare “SCA 8” ataxia that could be readily cured by gene editing – but it can’t get attention.

A sleeper factor also holds back treatment in America. The Washington Post article mentions scientific publication as being desirable for Russian medical development. To the extent that they report new knowledge and advances, scientific publications play critical roles.  But the U.S. suffers from a flood of excess clinical publications. Reports offer many promising new treatments “for the future” while there is a dearth of new treatment opportunities today. The reason is that it is more advantageous for medical researchers to apply for research funding and get their names in print or in the news for promising developments than to take the risks of moving to formal treatment. The latter receives little public recognition while it incurs major risks for lawsuits over new procedures. Risk adverseness operates on clinics as well as clinicians.

In 2016 I became personally familiar with a pioneering Austrian heart surgeon who saved the life of an American composer who had a heart attack while attending a concert in Vienna. Dr. Werner Mohl** developed a procedure for restoring heart tissue damaged in heart attacks. The American would probably have died in the U.S. because the procedure would not have been authorized until clinical trials proved its efficacy.

*Vaccines, 5th Ed., Philadelphia, Saunders 2008.


American history Civil War Personal

Confederate Monuments, Road Signs, And School Names: Don’t Put Them Out Of Sight And Mind

Why I’m writing about this subject. Current actions to remove Confederate statues and change the names of schools are in the news in Virginia. I have special reasons for offering suggestions on these sensitive issues.

In 2005 I had a “born-again African American experience”. An emeritus professor of chemistry at the University of Missouri, Kansas City and I unexpectedly discovered information buried for 50 years. We found that two former segregated black high schools in Kansas City Missouri and Kansas had dominated national science awards for all schools in Greater Kansas City through the 1950s and to 1965 (Manheim and Hellmuth 2006). This experience indirectly led me to greater insights about the Civil War.

Growing up and attending school in Kansas City MO during segregation, I remember wondering what education in the black schools was like. I took it for granted it would be second class. Classmates and I confidently assumed that our elite white high school was the best in Kansas City. So when research in 2005 showed that black schools had topped my and the other white schools in my fields of interest, chemistry and science, it shocked me to the core. How did they do this against the odds of discrimination and other handicaps of the times? It transformed and opened me to the black experience in America.

Getting back to high school days, I was fascinated by Civil War history. I knew slavery was wrong but am now ashamed to admit that I mentally separated the slavery issue from the military campaigns. I rooted for underdog Confederates and their colorful leaders like J.E.B. Stuart. I am afraid many Americans still separate Civil War battles from slavery.

The true horror of the Civil War. It’s only sixteen years ago that I grasped the true nature of the Civil War. Think of the death of 600,000 soldiers, many through infected wounds before Louis Pasteur’s germ theory of disease become known in the 1870s. Six hundred thousand men in 1864 is equivalent to 5.4 million in today’s population. Can we even begin to imagine the agonies of the men and the collective grief of affected families who lost sons, husbands, and fathers?

Unfortunately, that’s not the last word on this ghastly time in the nation’s history. Consider that half the nation went to war to defend the hideous institution of slavery at a time when Canada, Mexico, and European nations had already banned it – some (e.g. France) before the 14th Century. Great Britain’s Abolition Act banned slavery throughout the empire in 1834. Confederates did not die for a noble cause. Apologists have claimed that they fought for their culture, not slavery. That shallow argument won’t wash. Slavery was the only real bone of contention that separated the North and South. The Confederate states rebelled, seceded from the Union and began hostilities at Fort Sumter, South Carolina. Grievous failings in judgment lay with leaders and literate citizens of the South, as well as southern churches that justified slavery.

Robert E. Lee is on record writing that “slavery is a moral and political evil”, and regretted Virginia’s secession from the union. But he took the evil lightly, made excuses for it, and placed loyalty to Virginia and his perception of “honor” above human values asserted in the Declaration of Independence: “We hold these truths to be self-evident, that all men are created equal”.

Lee and J.E.B. Stuart were intelligent, educated men who swore allegiance to the nation as part of their officer training at West Point. What were they thinking when they abandoned their nation and assumed leading roles in defense of the reprehensible institution that subjugated African Americans?

The chilling answer – already articulated in the classic book by Alexis De Tocqueville, Democracy In America (1835, 1840) – is that Americans from early early history have been uniquely prone to be swept away by beliefs of the moment. The Founders knew about and feared this tendency. It’s the reason why they instituted multiple checks and balances in the Constitution. Don’t we see it continue to be displayed in today’s political developments?

So the Civil War is a bigger thing than most people realize. The last thing we should do is bury it out of sight and mind. That would sanitize the awful stain on the nation and let people forget the fateful mistakes in judgment that brought about events whose consequences have still not been completely overcome.

I suggest that – if we have the wisdom to face the realities – we preserve those monuments in museums or other well-kept places, accompanied by carefully crafted commentaries that remind of the costs of ignoring history and reason. Preaching would be counterproductive – unsparing, nuanced reality would be most effective. The lessons of history will be stronger and more acceptable if we allow that men like Lee and Stuart had estimable qualities as well as flawed judgment. African Americans should contribute their insights to such projects – since they have the greatest stake and insight into that history.

What about the names of boulevards and roads? Keeping names of notables linked to the Confederate rebellion could be an important educational opportunity – if the same kind of clarification were provided. Lee-Jackson Highway close to our house in Fairfax Virginia memorializes Robert E. Lee and Thomas Jonathan (“Stonewall”) Jackson, for whom the highway is named. Present and future generations need to be aware not only that they were great generals, but that they misguidedly led a bloody war defending an inhuman institution. Quarterboards or distinctive metallic plaques like those commemorating battlefields could remind future citizens of the ease with which decent humans can be drawn to inhuman causes.

School names often honor individuals in ways designed to offer inspiration for future generations. Confederate generals fail these standards in the contemporary world. It’s therefore only common sense to replace names of notables linked to the Confederacy. However, original names should be nevertheless be prominently displayed inside schools. They could be placed in smaller letters underneath the new name along with appropriate messages that remind school children of history and the damage that bad human decisions in the past did.

I have seen letters to editors of local papers belittling the idea of attaching signs to monuments. Yes, it would be uncomfortable and doing it right isn’t necessarily an easy job. But neither putting monuments out of sight nor facile expressions of guilt are what’s needed. Monuments ought to go into actively-visited museums or historical sites; soul-searching and artistic expression are called for if we want future generations to learn from the past while truly burying the pain and conflict associated with it.

Reference: Manheim, Frank T., and Eckhard Hellmuth. 2006. “Achievers Obscured by History ” U.S. Black Engineer June-July 2006.