Constructed of star dust, could “Guardian Angels” still exist?
Posted on | September 14, 2022 | 5 Comments
Mike Magee
“EXCLUSIVE: Royal beekeeper has informed the Queen’s bees that the Queen has died and King Charles is their new boss in bizarre tradition dating back centuries. … He placed black ribbons tied into bows on the hives, home to tens of thousands of bees, before informing them that their mistress had died.”
So read John Dingwall’s exclusive in the Daily Mail posted at 03:48 EDT, 10 September 2022. In defense of what might first appear a bizarre practice, others were careful to provide evidence that the practice, of informing fellow natural creatures of important human losses, is well documented in art and literature, such as in “Der Bienenfreund” (“The Bee Friend”), an 1863 painting by the German artist Hans Thoma.
That painting arrived on the scene nine years after the death of German philosopher Friedrich Wilhelm Joseph von Schelling, a stalwart of “German Idealism.” His focus (in part) was on “humankind’s relationship to nature,” a subject that has received a spotlight as our planet’s “climate emergency” status has become undeniable.
As Stanford’s philosophy department sees it, “Schelling’s account of mind and world, particularly his insistence on the need not to limit our conception of nature to what can be objectified by scientific methods, is, in the light of the ecological crisis, proving to be more durable than his reception might until recently have suggested. The question Schelling still poses is how the capacity for expanding human knowledge and control of nature can be reconciled with sustainable ways of inhabiting that nature.”
Death undeniably disrupts the human order of things, but does it destroy our connection to life? Can we feel after death, and can those behind us somehow “feel” us? Is our organic chemistry, our DNA, transportable, translatable?
In Genesis 3:19 the reference to ashes and dust reads, “By the sweat of your brow you will eat your food until you return to the ground, since from it you were taken; for dust you are and to dust you will return.” But is that a one way street, or do we somehow maintain a cosmic, knowing, helping presence?
Judged by the now dominance of cremation as a choice over traditional burials, our comfort with rapid reconnection to our chemical and natural parentage is growing at an amazing rate. In America, we crossed the majority threshold in 2015. Currently nearly 60% of Americans who die are cremated. By 2040, the National Funeral Directors Association confidently projects that cremation will be the choice of at least 8 in 10 of our dying citizens.
Analysts offer a variety of explanations from cost savings, convenience, new Vatican liberalism, family migration, lack of homestead, and more. But is that all that is at work here?
Is everything one, as the 23 year old Schelling long ago suggested? In 1798, he addressed a group of students in his home town square in Jena, Germany, 130 miles southwest of Berlin. The subject? The “secret bond connecting our mind with nature.” Expanding on the theme, he proclaimed, “At the first moment, when I am conscious of the external world, the consciousness of my self is there as well, and vice versa — at my first moment of self-awareness, the real world rises up before me…As long as I myself am identical with nature, I understand what living nature is as well as I understand myself.”
But does it work in reverse? As the headline read, “When the Queen Died, Someone Had To Tell The Bees.” But why? Did they need us to know what had happened, or could they sense it themselves – some break in the order of things – some disturbance?
And what if today our human actions have so poisoned and doomed the environment and its’ ecology, that the bees survival is hanging by a thread? Would they still be able to recognize the Queen’s entry into their realm? And if not, would her angelic dust lay useless at the wayside?
Constructed of star dust, it remains a human responsibility to act as “Guardian Angels” toward each other and the many life forms that share this fragile planet.
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In memory of our beloved oldest sister, Grace, who is a “guardian angel” to her husband Sam, her children and grandchildren, and her 11 younger brothers and sisters.
“Beyond Nicotine”: What Could Possibly Go Wrong With That?
Posted on | September 7, 2022 | Comments Off on “Beyond Nicotine”: What Could Possibly Go Wrong With That?
Mike Magee
Connecticut attorney general, William Tong, took a turn in the spotlight this week, representing 33 states and Puerto Rico in announcing that vaping original, Juul, had agreed to pay penalties of $438.5 million to settle law suits against the company.
Juul in essence acknowledged that the company’s marketers had targeted young students, used social media to attract underage teens, and had given them free samples. With 45% of the company’s Twitter followers between ages 13 and 17, and an age verification methodology authorities labeled as “porous”, they were happy to get the nation’s attorney generals out of their hair.
Over the past four years, Juul has lost over 95% of its value. When Altria bought a 35% stake in the company in December, 2018, they paid $12.8 billion. That translates to just $450 million today. What were they thinking? At the time, Juul was fighting to preserve their “flavor pods” – with mango and creme brûlée favorites among teens.
But the F.D.A. took a hard line, attempting to shut them down completely, attacking vaporized natural and synthetic nicotine. Lobbyists for Altria and Juul argued that they had helped 2 million Americans quit traditional cigarettes. That was enough to gain a “temporary reprieve”, sending the F.D.A. back to the drawing board for “additional review.”
By the way, local and state campaigns to curb teen vaping seem to have had an effect. E-cigarette use in a survey in March, 2022, found 8% or some 2 million teens had used an e-cigarette in the past 30 days. As for traditional smokers, 31 million are still addicted to cigarettes and 16 million currently have a smoking-related chronic disease.
In the meantime, tobacco giant, Philip Morris International, took a different tact. Last week they inked the purchase of Danish oral drug delivery company, Fermin Pharma, for $813 Million. They then “doubled-down” this week, announcing their intention to purchase “inhalation specialist” Vectura for $1.2 billion.
What are they up to? Their official site says this is all part of their “Beyond Nicotine” strategy, and will now be pursuing “respiratory drug delivery” and “selfcare wellness.” How much is that worth in future revenue. The company projects $1 billion in net revenues from these ventures by 2025. This is in part because Vectura has significant expertise with 13 inhalable products already on the market and $245 million in 2020 sales.
The concise market message reads:
“Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders.”
And PMI says the future is bright: “The market for inhaled therapeutics is large and growing rapidly, with significant potential for expansion into new application areas. PMI has the commitment to science and the financial resources to empower Vectura’s skilled team to execute on an ambitious long-term vision. Together, PMI and Vectura can lead this global category, bringing benefits to patients, to consumers, to public health, and to society-at-large.”
What could possibly go wrong with that?
What Could Possibly Go Wrong? Attacks On Women By Two Different Dobbs.
Posted on | August 30, 2022 | Comments Off on What Could Possibly Go Wrong? Attacks On Women By Two Different Dobbs.
Mike Magee
Under the definition for the noun, epidemic, there are two main (and distinctly different) definitions. I know this fact because it was the beginning point of my preparations earlier this summer for a Fall course on “The History of Epidemics in America” at the Presidents College at the University of Hartford.
The entry reads:
epidemic noun
ep·i·dem·ic | \ ˌe-pə-ˈde-mik \
Definition of epidemic (Entry 2 of 2)
1 : an outbreak of disease that spreads quickly and affects many individuals at the same time : an outbreak of epidemic disease
2 : an outbreak or product of sudden rapid spread, growth, or development an epidemic of bankruptcies
In my course, sessions 1,2, and 4 will be devoted to the first (and classical, microbe-centric) definition. But my third session will focus on “manmade” epidemics which fall under definition two.
I thought long and hard about this choice. The deciding factor was reading New York Times best selling author, Adam Cohen’s book, “Imbeciles.” It details the shameful story of “The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck.”
More on that tale in a moment, but in commentary on the book, Cohen states, “…in many ways, I believe you can learn more about an institution and more about an ideal like justice if you look at where it’s gone wrong rather than where it’s gone right.”
The tale of Carrie Buck is instructive, and sheds a damning light on our current Supreme Court and its’ recent decision, Dobbs v. Jackson Women’s Health Organization. In that case, Jackson Women’s Health Organization, Mississippi’s only abortion clinic, sued Mississippi state health officer, Thomas E. Dobbs, for relief from the state law prohibiting abortion after the 15th week of pregnancy.
Chief Justice John Roberts sided with the minority in this recent case. That decision to let the Mississippi law stand unearthed a bucket of repressive state laws with more likely to come. But we have been there before. All one need do is view the portrait of Chief Justice Robert’s hero, Justice John Marshall Harlan, which can be found on the wall to the left of the fireplace in the Justices Conference Room in the U. S. Supreme Court.
Of Justice Harlan’s many wise decisions, none is quoted more often than Jacobson v. Massachusetts (1905). In that decision, which supported fining one Methodist Minister who refused to comply with mandatory Smallpox vaccination, Justice Harlan wrote:
“Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others.”
For most progressive policy elites, this was a “slam dunk.” What could possibly go wrong here? Of course, they had not fully considered the “unintended consequences,” let alone the presence of zealots committed to advantaging the narrow opening created by the new decision.
At the time, President Wilson and others were focused on “strengthening the American stock.” This involved a two-prong attack on “the enemy without” and “the enemy within.”
The Immigration Act of 1824, signed by President Calvin Coolidge, was the culmination of an attack on “the enemy without.” Quotas for immigration were set according to the 1890 Census which had the effect of advantaging the selective influx of Anglo-Saxons over Eastern Europeans and Italians. Asians (except Japanese and Filipinos) were banned.
As for “the enemy within,” rooters for the cause of weeding out “undesirable human traits” from the American populace had the firm support of premier academics from almost every elite university across the nation. This came in the form of new departments focused on advancing the “Eugenics Movement,” an excessively discriminatory, quasi-academic approach based on the work of Francis Galton, cousin of Charles Darwin.
Isolationists and Segregationists picked up the thread and ran with it focused on vulnerable members of the community labeled as paupers, mentally disabled, dwarfs, promiscuous or criminal.
In a strategy eerily reminiscent of that employed by Mississippi Pro-Life advocates in Dobbs v. Jackson Women’s Health Organization in 2021, Dr. Albert Priddy, activist director of the Virginia State Colony for Epileptics and Feebleminded, teamed up with radical Virginia state senator Aubrey Strode to hand pick and literally make a “federal case” out of a young institutionalized teen resident named Carrie Buck.
Their goal was to force the nation’s highest courts to sanction state sponsored mandated sterilization, and thus allow the spread of the practice nationwide. This required a test case and a defense attorney for the victim, who was hired by Dr. Priddy. Carrie Buck was chosen as the target.
In a strange twist of fate, the Dobbs name was central to this case as well. That is because Carrie Buck was under the care of foster parents, John and Alice Dobbs, after Carrie’s mother, Emma, was declared mentally incompetent. At the age of 17, Carrie, after having been removed from school after the 6th grade to work as a domestic for the Dobbs, was raped by their nephew and gave birth to a daughter, Vivian. This lead to her mandated institutionalization, and subsequent official labeling as an “imbecile.”
Dr. Priddy applied for official permission for forced surgical sterilization of the girl, and had his hand-selected defense attorney oppose his actions in court. To bolster his case for sterilization, Priddy enlisted the aid of a well-known Eugenics Professor, Harry Laughlin, who testified during the trial that Carrie suffered from “…social and economic inadequacy; has a record during life of immorality, prostitution, and untruthfulness; has never been self-sustaining; has had one illegitimate child, now about 6 months old and supposed to be a mental defective.”
In his majority decision supporting Dr. Priddy, Buck v. Bell, Supreme Court Chief Justice Oliver Wendall Holmes leaned heavily on precedent. Reflecting his extreme bias, he wrote: “The principle that supports compulsory vaccination is broad enough to cover the cutting of Fallopian tubes (Jacobson v. Massachusetts 197 US 11). Three generation of imbeciles are enough.” Carrie Buck underwent tubal ligation against her will at the institution on October 19, 1927.
What followed was predictable. By 1930, 24 states had passed their own laws allowing involuntary sterilizations. Between 1927 and 1974, 60,000 Americans were sterilized including 7,500 victims in the state of Virginia. That state’s sterilization law was repealed in 1974, and in 1980 an ACLU suit forced to make reparations. On May 2, 2002, Virginia Gov. Mark Warner publicly apologized for Virginia’s eugenics program.
Carrie Buck lived to age 76, had no mental illness, and read the Charlottesville, VA newspaper every day, cover to cover. There is no evidence that her mother Emma was mentally incompetent. Her daughter Vivian was an honor student, who died in the custody of the John and Alice Dobbs at the age of 8.
When it comes to American Epidemics, It Is As Much About Us As It Is the Microbes We Encounter.
Posted on | August 24, 2022 | Comments Off on When it comes to American Epidemics, It Is As Much About Us As It Is the Microbes We Encounter.
Mike Magee
Epidemics don’t appear in isolation of geography, social status, race or economics.
In a recent Kaiser Family Foundation article, the authors reviewed case numbers and death rates organized by race/ethnicity. It will come as no surprise that the most vulnerable population’s death rate is nearly three times greater than the least vulnerable. But what may surprise you is that the population at greatest risk was neither self-identified as Black or Hispanic, but Native American.
Sadly, this is not a new story, but in the analogues of American history, it has been papered over by a partially true, but incomplete, narrative. That story line was largely popularized by the book, “Guns, Germs, and Steel.” Published in 1997, author Jared Diamond explained that European colonists, arriving in the Caribbean islands in the late 15th century, carried with them a variety of diseases like smallpox and measles, and transmitted them to an indigenous people that had no prior exposure to these deadly microbes.
Two years ago, University of Oregon Professor of History Jeffrey Ostler challenged the “virgin-soil” hypothesis in an article in The Atlantic. In his words, “Although the virgin-soil-epidemic hypothesis may have been well intentioned, its focus on the brief, if horrific, moment of initial contact consigns disease safely to the distant past and provides colonizers with an alibi. Indigenous communities are fighting more than a virus.”
Students of American history are already more than familiar with the impact of infectious diseases on the natives of Saint-Dominique (now Haiti) in the late 18th century, but also the advance of disease northward that followed and eventually enveloped our own Native Americans.
Best known among the documented tragedies of the 19th century is the Cherokee Trail of Tears. While immunologic susceptibility unquestionably played a role in the event, the forced expulsion of the Cherokees from Georgia, North Carolina, and Tennessee, in three phases was a complex and multi-faceted disaster.
It began with the U.S. Army destroying native homes and detaining our earliest Americans in concentration camps or holding pens for several months. Without decent shelter and sanitation, and limited food and water, disease thrived. Of the 16,000 contained, 2000 immediately perished primarily from dysentery, but also diseases like measles, whooping cough, and malaria.
Severely weakened, the forced march west that followed as a second phase, resulted in an additional 1500 deaths. Finally, the early months of relocation in Oklahoma, sacrificed an additional 500 souls. In all then, 4,000 of the original 16,000 died.
This complex intermingling of disease and severely compromised and susceptible human hosts played out again and again in the years following the 1830 Indian Removal Act. That federal legislation directed the “forced relocation of all Native peoples east of the Mississippi River to ‘Indian Territory’ – the future Oklahoma and Kansas.”
Forced migration, accompanied by exposure to the elements, malnutrition, and violent warfare attacks along the way, created a deadly brew – and that was before disease intervened. The Cherokees were not the only victims in the two decades between 1830 and 1850. A partial list of other tribes includes Creeks, Seminoles, Chickasaws, Choctaws, Senecas, Wyandots, Potawatomis, Sauks and Mesquakies, Ojibwes, Ottawas, Miamis, Kickapoos, Poncas, Modocs, Kalapuyas, and Takelmas.
The trail of the Sauks and Mesquakies from western Illinois to Oklahoma occurred in four segments, with a staggering 85% mortality rate. During their migration, dislocation, and for years after their relocation, fertility rates plummeted and maternal-infant mortality soared.
Professor Ostler does acknowledges the value of the “virgin-soil” hypothesis, but with caveats. As he wrote, “The virgin-soil-epidemic hypothesis was valuable in countering earlier theories that attributed Native American population decline to racial inferiority, but its singular emphasis on biological difference implied that population collapses were nothing more than historical accidents.” And, as is commonly claimed, History repeats!
Of Native Americans, it has been fairly said, “They are contending with the ongoing legacy of centuries of violence and dispossession… Countering the invisibility of Native peoples, of course, means greater awareness of how COVID-19 is affecting them and enhanced efforts to provide resources to help them combat the current outbreak…”
On the broader issue of epidemics in America, past and present, it is useful to be reminded, it is as much about us as it is the about the microbes we are forced to encounter.
My Fictional Day At The Beach With Lindsey Graham.
Posted on | August 15, 2022 | 2 Comments
Mike Magee
Senator Lindsey Graham (R.,S.C.) is on summer recess. A consummate professional politician, and war hardened lawyer, Sen. Graham has made a career out of flipping on a dime. His moral calculus has been flexible enough to wiggle and weave, and switch sides if cornered.
In my dreams, I caught a glimpse of him reading on one of his state’s beautiful beaches. He was juggling a weighty 1215 page classic – Leo Tolstoy’s “War & Peace” in one hand, and a yellow highlight marker in the other.
He looked a bit on edge, maybe because this week a federal judge refused to block a subpoena seeking his testimony for a Fulton County, Georgia, Grand Jury probe into efforts by then-President Donald Trump and his potential state Republican “alternate electors” to overturn Georgia’s Biden victory in the 2020 election.
When he hit the water to cool off, his book was just sitting there on a Polo beach blanket. I couldn’t help but notice the MAGA bookmark – it’s was on page 1133 with these words highlighted:
“Chance made the situation; genius profited from it…””, and Lindsey’s scribbled notation “IMPORTANT.”
Judging from the heavy highlighting, it seemed Lindsey had been carefully rereading a tattered personal copy, and OCD’ed on Tolstoy’s Epilogue, pages 1131 to 1136.
Lindsey was obviously looking for some insight how to manage his current predicament in Tolstoy’s literary undressing of Napoleon.
Right there on page 1133, he had scrawled across the top – “WOW.”
The second and third paragraph seemed to have resonated because there was a yellow line along the left margin:
“…the old insufficiently large group is destroyed; old customs and traditions are obliterated; step by step a group of a new size is produced, along with new customs and traditions, and that man is prepared who is to stand at the head of the future movement and bear upon himself all the responsibility for what is to be performed…A man without conviction, without customs, without traditions, without a name, not even a (military man or politician), seemingly by the strangest chances, moves among all the parties stirring up (hatreds), and, without attaching himself to any of them, is borne up to a conspicuous place.”
The fourth paragraph was floating in a yellow bath, and in the margin a text box with arrow read, “This hurts!”
“The ignorance of his associates, the weakness and insignificance of his opponents, the sincerity of his lies, and the brilliant and self-confident limitedness of this man moved him to the head…the reluctance of his adversaries to fight his childish boldness and self-confidence win him…glory…The disgrace he falls into…turns to his advantage. His attempts to change the path he is destined for fail…Several times he is on the brink of destruction and is saved each time in an unexpected way…the very ones who can destroy his glory, do not, for various diplomatic considerations…”
Turning the page, there was a scribble on page 1134 next to the 1st new paragraph, “TS/SCI/ Mar-a-Lago.” And on the other margin, “Soooo True!”:
“The ideal of glory and greatness which consists not only in considering that nothing that one does is bad, but in being proud of one’s every crime, ascribing some incomprehensible supernatural meaning to it – that ideal which is to guide this man and the people connected with him, is freely developed…His childishly imprudent, groundless and ignoble (actions)…leave his comrades in trouble…”
In the middle of the same page, again in Lindsey’s hand, “NO PLAN”:
“He has no plan at all; he is afraid of everything…He alone, with his ideal of glory and greatness…with his insane self-adoration, with his boldness in crime, with his sincerity in lying – he alone can justify what is to be performed…”
And on adjoining page 1135, across the top, “HE’S GOING DOWN.”
with a highlighted last paragraph that read:
“But suddenly, instead of the chances and genius that up to now have led him so consistently through an unbroken series of successes to the appointed role, there appear a countless number of reverse chances….and instead of genius there appears an unexampled stupidity and baseness…”
As I began to stir, Lindsey was heading my way. Just time for one more page flip. Page 1136 and 1137.
“…all his actions are obviously pathetic and vile…deprived of strength and power, exposed in his villainies and perfidies…not only does no one arrest him, but everyone greets with rapture the man they cursed the day before and will curse a month later. This man is needed to justify the last joint act. The act is performed. The last role has been played. The actor is told to undress and wash off his greasepaint and rouge; there is no more need for him…The stage manager, having finished the drama and undressed the actor shows him to us. ‘Look at what you believed in! Here he is! Do you see now that it was not he but I who moved you?’”
Lindsey’s smeared notation in permanent black marker,
“MY NEXT MOVE.”
Monday in America – Message on Positive Leadership from Karen Katen.
Posted on | August 8, 2022 | Comments Off on Monday in America – Message on Positive Leadership from Karen Katen.
Mike Magee
With President Biden’s positive leadership at home and abroad, our nation this Monday morning in August, appears to be turning the corner.
While clearly not out of the woods yet, we Americans and our form of government has withstood a serious stress test, one led by a rogue leader and a party (unlike the former Watergate crisis) that for some reason decided to follow this false Messiah rather than muster the strength to resist and do their duty.
The damages, including an assault on women rights and their autonomy over their own bodies, will need to be undone. But steps like this weekend’s passage of “Inflation Reduction Act” and last week’s Kansas 59% vote to say “no” to radical abortion legislation provide more than a glimmer of hope.
The battle between positive and negative leadership is not a new phenomenon, though seldom have we seen it in such sharp relief. I have studied and published on this very topic for over four decades. My 1995 publication, POSITIVE LEADERSHIP, contains 10 cornerstone themes, and 52 personal challenges, which appear to “hold up” in my re-read early this morning.
About this book, my friend, Karen Katen, President of U.S. Pharmaceuticals for Pfizer Inc., wrote in 1999:
“Truly effective leadership requires more than a commitment to performance—it also requires a positive attitude and a healthy, balanced perspective on life. This is the power of Dr. Mike Magee’s Positive Leadership. Transcending religions and philosophies, Mike has crafted a work of immutable, undeniable positive truths about life and how ones life ought to be lived.
While warmly told from the author’s own experience, the actual voice is eerily familiar. It is nothing less than the reader’s own inner voice, all too often lost in the din of our modern times. In other words, Mike’s simple lessons are ones we know to be right and true, and have always known to be right and true—we may have just forgotten or misplaced them.
With its compelling clarity, Mike’s work is more than just a useful reminder. It serves as a practical solution for those individuals and organizations that are experiencing a disconnect between their actions and their values.
Its timeless themes make Positive Leadership nothing less than a moral survival manual. No home or office should be without it.”
In these words, Karen encapsulated the challenge we, as Americans, face now 23 years later. We have encountered and partially confronted as a nation:
- Lessons “forgotten or misplaced.”
- A “disconnect between actions and values.”
- And “our own inner voice” or “moral survival manual” to guide us back home.
Karen’s message for America is hopeful, practical and doable. It has also never been more important than on this Monday in America.
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If you would like to read POSITIVE LEADERSHIP, it is available free online HERE. If you would prefer a hard copy, it is available on Amazon HERE.
“Revolving Door” Doesn’t Quite Describe It. It’s Lou Lasagna’s “Integrated Career Ladder.”
Posted on | July 28, 2022 | 2 Comments
Mike Magee
Last week, the New York Times shinned a light on the FDA’s top science regulator of the tobacco industry, Matt Holman, who announced his retirement after 20 years to join Phillip Morris. As they noted, “To critics, Dr. Holman’s move is a particularly concerning example of the ‘revolving door’ between federal officials and the industries they regulate…”
As a Medical Historian, I’ve never been a fan of the casual “revolving door” metaphor because it doesn’t quite capture the highly structured and deliberate attempts of a variety of academic medical scientists over a number of decades in the 2nd half of the 20th century to establish and reward an “integrated career ladder” that connected academic medicine, industry and the government.
As I noted this week, Harvard’s Dr. Henry K. Beecher, raised a red flag in 1966 in a NEJM article, “Ethics and Clinical Research”, where he wrote, “Medical schools and university hospitals are increasingly dominated by investigators. Every young man knows that he will never be promoted to a tenure post, to a professorship in a major medical school, unless he has proved himself as an investigator. If the ready availability of money for conducting research is added to this fact, one can see how great the pressures are on ambitious young physicians.”
In CODE BLUE: The Birth of the Medical-Industrial Complex, I recount the vertical integration strategies of deception that were Arthur Sackler. But the role model for the “young physicians” of his day was not Sackler, but rather the physician and pharmacologist Louis Lasagna who had trained at Johns Hopkins. In 1956, he lobbied the FDA to develop a separate metric beyond “safety” to assess the effectiveness of new drugs coming to market.
As a contrarian, he was an equal-opportunity offender, often sought after for media commentary. He had challenged the pharmaceutical industry’s over-the-top marketing claims, outrageous prices, and deceptive relationships with doctors nationwide in the 1950’s, but also was not shy about criticizing his fellow physicians’ dismal state of expertise in all things pharmacologic.
In 1962, Lasagna’s knowledge and outspokenness led to an invitation to join the government team evaluating FDA policy. When he appeared before Estes Kefauver’s congressional committee, he made headlines in Arthur Sackler’s hometown by lamenting the fact that money was corrupting doctors’ professional decision-making choices, or as he put it, “Madison Avenue” had discovered “Medicine Avenue.” He also labeled the science involving the “equivalency” of generic products “abysmally ignorant” and the standards for quality “inadequate.”
The committee to which Lasagna said all these things went on to craft the Kefauver-Harris Amendment, or the Drug Efficacy Amendment, to the Federal Food, Drug, and Cosmetic Act. Adopted in 1962, the amendment introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and prevented cheap generic drugs from being marketed under new trade names as “breakthrough” medications.These requirements were retroactive, meaning that more than 4,000 drugs that had appeared on the market between 1938 and 1962 needed to be critically evaluated.
To determine these drugs’ effectiveness, the government created the Drug Efficacy Study (DES), which involved multiple panels of experts drawn from the National Academy of Science and the National Research Council. The lead voice on the DES was the outspoken Louis Lasagna. He had acknowledged industry support of his fellowship programs in clinical pharmacology at Johns Hopkins, and, with the support of the American Enterprise Institute, he had endorsed collaboration between “universities and the pharmaceutical industry . . . to join forces in providing reasonable advice to government . . . to prevent unwise participation of the government in drug development.” If Lasagna occasionally slammed the drug industry as well, that was just Lou being Lou.
Not shy in promoting himself or his ideas, Lasagna had a knack for deleting embarrassing details from his ever-expanding professional narrative. Few knew that he had unsuccessfully pressured the FDA to approve thalidomide on behalf of its US manufacturer, RichardsonMerrell. Fewer still remembered his publicly quoted remark following the barbiturate-overdose death of Marilyn Monroe in 1962: “If Marilyn Monroe’s physician had been able to prescribe that drug (thalidomide) instead of barbiturates she might still be alive.”
In the early years following the thalidomide disaster, the American people and their government were willing to accept the new rules and the delays in drug development they fostered. However, they became less tolerant a decade later when a deep recession, accompanied by high interest rates and extraordinarily thin pipelines for new discoveries, stubbornly resisted corrective steps.
Lasagna was all about free enterprise and eliminating what he viewed as excessive government regulation. That worldview was well capsulized in remarks he made in 1976. Quoting Rochester Chancellor Wallis, Lasagna said, “‘The remedy . . . is obvious and simple, but implausible. Return the power to the people.” In 1970, Lasagna became chairman of the Department of Pharmacology and Toxicology at the University of Rochester’s School of Medicine, where he founded the Center for the Study of Drug Development (CSDD), a common meeting ground for free market–minded academics, government, and corporate leaders. By 1976, he had moved his center to Boston’s Tufts University. He was now a renegade scholar, a successful entrepreneur, and a lightning rod for controversy. But within the business community, he was a much-sought-after speaker, much like California’s Ronald Reagan had become.
From the start, Lasagna’s CSDD was a multifaceted and highly productive platform, providing professional development courses in clinical pharmacology, drug development, research processes, and pharmaceutical regulations. It generated influential white papers and reports on everything from clinical research design to the growing trend of outsourcing work to contract (or clinical) research organizations (CROs). It also provided customized reports helping individual clients design their government-relations strategies in pursuit of favorable policies.
Throughout the 1970s, the pharmaceutical-industry-funded CSDD under Lasagna laid the statistical groundwork to “prove” that the pharmaceutical industry was “high risk/high gain,” that government-induced delays eroded patent life and profitability, and that inadequate protection of intellectual property rights discouraged investment, discovery, and innovation. New drug launches in the US had dropped to around 40 per year, and for nearly all of these, the drug’s appearance in Europe preceded its US debut by approximately two years. Lou labeled the delay a “drug lag,” and pegged the cost of bringing a new drug to market at $800 million and the losses associated with a one-month delay in a product review by the FDA at $10 million for the sponsoring company.
When Reagan came to power in 1980, it was Lasagna who led the way in wholesale deregulation of the Medical-Industrial Complex including special channels for rapid drug approval and forfeiture of NIH patents (Bayh-Dole Act) that financially super-charged the “integrated career path” as a scaffolding for the MIC for the following four decades.