KLG: Owning the Sun: A People’s History of Monopoly Medicine from Aspirin to COVID-19 Vaccines – A Review-Essay

By KLG, who has held research and academic positions in three US medical schools since 1995 and is currently Professor of Biochemistry and Associate Dean. He has performed and directed research on protein structure, function, and evolution; cell adhesion and motility; the mechanism of viral fusion proteins; and assembly of the vertebrate heart. He has served on national review panels of both public and private funding agencies, and his research and that of his students has been funded by the American Heart Association, American Cancer Society, and National Institutes of Health.

It goes without saying that Biomedicine, defined here as the biomedical sciences, medicine, and Big Pharma, has not covered itself with glory during the past three and a half years.  When confronted with a worldwide pandemic caused by a lethal virus that had appeared in somewhat different form only a few years before as the causes of the SARS and MERS, which were more lethal but less transmissible, we were told to “trust the science.”  That this rank scientism [1] has been the very opposite of an effective response is a topic for the future, but here we are.  The question is how did we get here and where do we go now?

As a sometime biologist who has been happiest (at work) in the lab, where you get something useful done only by spending at least half of your time “doing” and the other half “reading and thinking while staring out the window,” this has been disappointing.  When I was asked at the beginning of the COVID-19 lockdown 40 months ago, “How long will this last,” my reply to my lifetime partner, who has for 40 years put up with a lab time of 30 minutes equaling two hours, was “three years.”  Apparently, this was the time limit of our politicians and the scientific establishment, too.  Alas, as noted here a few days ago, COVID-19 and Long Covid will continue for the foreseeable future.  The outcomes are unknowable but likely to be serious.  Despite the medium and the message, COVID-19 is here and not going anywhere for a long time if we continue along our current path.  It is easy to believe that had the scientific establishment spent as much effort thinking well as well as doing, the outcomes would have been different.

Where and why did Biomedicine miss the big chance?  My immediate response was to think back to my days as an apprentice scientist working on sea creatures that glow in the dark.  As a biologist, my ultimate goal has been to discover things, and I have been fortunate in a small way to do just that on the few occasions that make the calling worthwhile.  But as I was getting started as an independent scientific worker, something happened.  Although I was apparently the only denizen of that lab who paid attention to politics, what was given the name Bayh-Dole Act of 1980 came as a surprise to me.

But scientists tend to be proud of their “immunity” to and from politics, and I got a lot of side-eye due to the Boycott Nestle sticker on the wall beside my desk.  My immediate reaction to Bayh-Dole was to blurt out something to the effect, “Great! This means we will have to pay for everything several times, first when our taxes support the scientists who make the discoveries and later as transnational corporations figure out how to ‘leverage’ public knowledge into selling back to us what we have already paid for, again and again.”  More side-eye.  Over the past several decades I have from time to time looked into the Bayh-Dole literature.  Most of the business press has seen Bayh-Dole as a triumph.  Others disagree.  I thought it was basically a scam at the time. [2]  I was not the only one, but we were in a distinct minority.  And society is still paying the price.

This is the subject of a remarkable book published last year by a favorite publisher, Counterpoint Press of Berkeley: Owning the Sun: A People’s History of Monopoly Medicine from Aspirin to COVID-19 Vaccines, by Alexander Zaitchik.  As suspected, the history is longer and more convoluted than I understood.  A good place to begin is the quote from the front matter of this book:

Inventions financed with public funds should inure to the benefit of the public, and should not become a purely private monopoly under which public-financed technology may be suppressed, used restrictively, or made the basis of an exaction from the public to serve private interests…Public control will assure free and equal availability of the inventions…[and] will avoid undue concentration of economic power in the hands of a few large corporations…Scientific and technological research conducted by the United States represents a vast national resource, rivaling in actual and potential value the public domain opened to settlement in the last century…The soundest disposition of Government-financed technology is as a general rule to open it freely to the public…and spread the benefits of the scientific advances as widely as possible.

• Final Report of the Attorney General to the President on Government Patent Practices and Policies, 1947.

This makes perfect sense, to the scientist of the old school.  Alas, things have not turned out that way.  And Mr. Zaitchik explains why in 250 focused pages of explanation and barely sublimated dissatisfaction.

The overarching theme of Owning the Sun is that science, and especially Biomedicine is a public good, mostly because it developed as a modern discipline with public support. [3]  Nor does “intellectual property” protected and hoarded by patents have a long history in all nations.  Although the world has come around to the Anglo-American idea that owning ideas is legitimate as well as essential, the first patents on drugs were not issued until 1977 in Switzerland, the Big Pharma powerhouse [e.g., Hoffman-LaRoche and Novartis (Ciba-Geigy plus Sandoz)] of Basel.  Drug patents first appeared in 1978 in Italy and Sweden, and 1992 in Spain.  They have a much longer history in the United States.

Chapter 2: Ethical Medicine and the Republic of Science repays close reading, beginning with the origins of medicine in religion in Sumer [4] and later with the cult of Asclepius. The foundation of medicine in “religious institutions shaped the conception of…medical and scientific knowledge (which were) considered gifts from the mind of God, free to all and belonging to no earthly power.  Any expression or use of this knowledge, including novel and potentially profitable ones, remained God’s gift.”  As Lewis Hyde has noted, “To traffic in its fruits was the sin of simony.”  This conception has been beaten down but was present at the origin of medicine and has remained a persistent, hidden undercurrent during the development of modern Biomedicine.

From Martin Luther to Benjamin Franklin to Wendell Berry, “Freely have I received, freely have I given, and I desire nothing in return.”  Words to live by.  Or not.  At the founding of what became the American Medical Association in 1847, the code of ethics declared that patents are “incompatible with the duty and obligation of physicians to advance the knowledge of curing diseases.” [5]  The code of ethics of  American Society for Pharmacology and Experimental Therapeutics (1908) rejected both patents and monopoly by the companies that produced drugs, researchers who did the work, and physicians who treated their patients with these medicines.

Times have changed.  “Not” has won out in the larger political economy, and this story is told well in Owning the Sun.  In Chapter 3, Death of the Taboo, we are introduced to something called the Wisconsin Alumni Research Foundation (WARF), which was established in 1925.  WARF remained distinct from the University of Wisconsin and was used to manage patents and “intellectual property” that originated in the university.  Similar appurtenances now manage grant awards and “intellectual property” in most research universities, providing the “thinnest buffer separating the sacred from the profane.”  But not without argument then or now.  The editor of Hoard’s Dairyman (1885) asked “Why should the public devote money to discovering new truths only to permit them to be patented and their use determined by some corporations…It seems to me that information discovered by the use of public money belongs to the public (and should not be) patented and some private corporation determine how they should be used.”  A good point that is mostly missed in public but not totally forgotten in the academy.  Yet.

But “Not” didn’t win until the New Deal finally lost.  The New Dealers of the time were led by Thurman Arnold, the Assistant Attorney General for Antitrust in Franklin Roosevelt’s administration from 1938 to 1943.  In 1937 Arnold published The Folklore of Capitalism, which noted that “the myths of American individualism, self-reliance, and autonomy had become mismatched with the facts of modern industrial society, resulting in policies and outdated thinking that ranked among ‘the most unrealistic in the world’…(leading to) magical thinking, bad policy, and undemocratic concentrations of power: corporate personhood and an outdated, idealistic attachment to the patent as a sensible reward for plucky ‘lone inventors.’”  Thurman Arnold was followed by Alfred Kahn [6], who maintained that “the individualistic conception of the process of invention was a fallacious assumption…(and)…to look upon a single inventive contribution as patentable and exploitable, one must look upon each invention as an entity, self-contained  and distinct from all others.”  This is absurd in the era of complex transdisciplinary research.  But the notion is now “common knowledge,” and it led directly to the rise of Big Pharma.

Chapter 7: The Making of a Monster explains the contradiction at the core of modern medicine: “Even during its ethical golden age, organized medicine evinced a moderate schizophrenia.  In its view of science, knowledge, and medicine, it was proudly communistic.  But when it came to healthcare – the administration of medicine – it was fiercely capitalistic and antisocial.”  For example, the AMA lobbied to overturn a 1921 law that funded the nation’s first women’s health clinics, which in the view of organized medicine intruded into its “business.”  These clinics were closed in 1927.  President Roosevelt later “chose” to omit healthcare from the Social Security Act of 1935.  Throughout this time, the AMA also forced medical schools to reduce their enrollment.  Yes, surprising as it may seem, the actions of the AMA have at times been inimical to healthcare in the broader community.  President Truman’s healthcare initiative was unsuccessful even though he pointed out that his program was not “socialized medicine” (not that that would be a bad thing), and that people would still have freedom of choice in choosing their doctors, but with the difference that patients’ getting the care they needed when they needed it would not depend on how much they could afford to pay.

Politics simply turned and mid-century liberalism was ushered out of the discussion.  In 1958 The Journal of Law and Economics was first published at the University of Chicago, with financial support from the drug fortune of the Lilly family of Indianapolis.  At the beginning of the Chicago School, Henry Simons was a leader and the group’s antitrust conscience, and remarkably, “he did not apologize for advocating the use of state power to maintain an even playing field as the precondition of a free market…and described the Federal Trade Commission as the most important government agency.”  Alas, Simons died in 1946, and the contingency of history is illustrated once again.  He was followed by Robert Bork and Edward Levi, Dean of the University of Chicago Law School.  Bork needs little introduction, but Levi, who was Attorney General in the Ford Administration, argued that “corporations benefited the wider economy by practicing exclusionary and anti-competitive behavior.”

Next came George Stigler, who at one time had been a follower of Henry Simons.  But later Stigler developed the theory (and justification) for regulatory capture.  He argued that “because industries targeted by state regulation have more at stake than the public or the agency overseeing the regulation, those industries will inevitably gain control of the process.”  This is not dissimilar to the NC post of Thomas Ferguson’s essay last Saturday.  Stigler no longer held his earlier views that countermeasures such as strengthening democratic oversight and preventing the runaway growth of corporate power would be useful or necessary. [7]  In this environment it was but a short hop to Big Pharma and Evidence-Based Medicine as we have come to know them.

Which brings us to Chapter 8: Bayh-Dole and the Reagan Acceleration.  The question for me at the time and since has been “Why Bayh-Dole”?  The 1970s were a challenging time.  The Great Compression was ending and stagflation reigned.  After the two oil shocks of the 1970s, the economy was a mess.  A key to recovery was identified in “competitiveness,” as in “Unless U.S. firms had exclusive access to the latest science to do with what they pleased on a monopoly basis, they would be crushed on the global stage by technological rivals.”  The argument rings familiar to those of us who were there.  Joseph Califano, one of the few old-school liberals in the Carter Administration, was Secretary of the Department of Health, Education, and Welfare (now Health and Human Services) for the first two and a half years of the Carter Administration. Califano was skeptical of this justification but did not prevail.  He was fired by Jimmy Carter in 1979.

Eventually the University and Small Business Patent Procedures Act was introduced into the U.S. Senate.  Recall that The Journal of Law and Economics was seeded with money from the Eli Lilly family of Indianapolis.  What became known as the Bayh-Dole Act of 1980 is named for Senator Birch Bayh of Indiana, which was not an accident, and Bob Dole of Kansas.  I don’t know how many cosponsors Bayh-Dole had, but they were surely well into the majority.  The bill was renamed the Patent and Trademark Law Amendments Act and signed by Jimmy Carter on December 12, 1980, the last day of the 96^th Congress.  It would now be up to “the government to prove its possession of a patent would better serve the public than a private monopoly.”

A law that was nominally intended as a benefit to universities and small businesses was changed at the behest of Ronald Reagan in 1983-1984 to include corporations of all sizes.  And now we find ourselves in the land of the CRADA, or the “cooperative research and development agreement.” [8]  Harvard had directed in 1934, during an “ethical phase” of Biomedicine, that all patents related to “therapeutics or public health” remain in the public domain.  Beginning in the 1980s such partnerships were defined by corporate partners.  President Derek Bok of Harvard conceded the “dangers to academic science seem real and severe.”  This has been my experience.

Much more followed.  A special court was established to rule on patents.  The Warren Burger Supreme Court decided in 1980 that modified genes, which are a product of nature, however they are prepared and used, can be patented.  The commercialization of the science of Biomedicine grew exploded.  Big Pharma attacked generic drugs, with the notable art patron Dr. Arthur Sackler leading the campaign to highlight the alleged dangers of “drug counterfeits” and “the fallacy of generic equivalents.”

Generics did not die, but aggregate spending on prescription drugs increased because Big Pharma raised the prices on their protected monopoly products and sold them in a captive market.  Among other things, Big Pharma essentially ceased its research in infectious diseases.  According to a source in position to know because he was leading the program, a promising approach to novel antibiotics was discontinued by one of the biggest of Big Pharma, probably because the projected financial payoff was too low.  An antibiotic, no matter how expensive, usually works quickly with no long-term payoff from the patient’s treatment.  Or as the up-from-the-shop-floor CEO of Pfizer, John McKeen, put it in 1954, “If you want to lose your shirt in a hurry, start making penicillin and streptomycin.”  Streptomycin was the first antibiotic used successfully to treat tuberculosis.

At the same time the first drug that was active against HIV (AZT) was priced out of the reach of many in the Global North, and virtually everyone in the Global South.  The World Trade Organization (WTO), which we tend to forget was born in 1995 as the successor to GATT (General Agreement on Tariffs and Trade, 1947-1995), was instrumental in this, especially as HAART (Highly Active Anti-Retroviral Therapy) became available in 1994-1996.  Granted, the AZT class of antiretrovirals came out of the research of Gertrude Elion and George Hitchings at Burroughs-Wellcome (now GlaxoSmithKline) on anticancer drugs, but these were developed primarily with public support in the United States and Europe before they became the property, intellectual and otherwise, of Big Pharma.  The initial price of HAART triple therapy was between $10,000 and $15,000 for a one-year course, nearly 30 years ago.  This “price point” left 99% of the world’s HIV-positive population priced out.  The Indian company Cipla introduced the same therapy for $350 a year, less than a dollar a day.

We began with COVID-19 and now is a good place to return.  Owning the Sun was written during the first part of the current pandemic, and the actual progression of COVID-19 has overtaken some of the science that is covered in the book.  But not the institutional response.  At the beginning of the pandemic in early 2020, the World Health Organization outlined an “open science” approach to the pandemic.  Whatever one thinks of the WHO, this was and remains the correct course.  It was naturally, if naively, expected that this model of cooperation would work.

Instead, Gilead Sciences attempted to extend its monopoly on remdesivir, [9] but pushback prevented the company from proceeding.  Roche surrendered to public outrage in the Netherlands when they refused a request by the Dutch government to share proprietary information for an early COVID-19 test kit.  Operation Warp Speed was a giant subsidy to Pharma, large and small.  Mostly large.  Pfizer and Moderna collected more than $50 billion for their mRNA vaccines in the first year of their availability.  Eli Lilly made about $300M adjusted for inflation for producing the Salk vaccine during the first wave of polio vaccinations in the 1950s.  COVID-19 vaccines currently in development will be “reasonable” at $110 – $130 per dose (a 5-fold increase over the current price, but perhaps they will work better).  Moderna executives caught the first wave of an early pump and dumped stock worth $30M before concerns about their mRNA-1273 vaccine appeared in the media.  As noted, “On the scale of corporate misdeeds, the Moderna sell-offs were small…but served as a reminder that private interests…were hardwired to maximize market control and profits…rather than to inoculate the world with the most effective vaccines as quickly as possible.” [10]

This proprietary attitude, led by the usual suspects, remains as we feel our way through this worldwide crisis.  So, my suspicions that Bayh-Dole was somehow interfering with our response to COVID-19 were only half-right.  The story has much deeper roots.  But the view that Biomedicine has lost the plot is correct.  And the stories in Owning the Sun, many of which are relatively unknown, are telling.

As in diphtheria, for example, which is an airborne bacterial disease spread in close quarters like crowded tenements.  This “childhood” disease was known as the “strangling angel” in the 19^th century.  When left untreated it can be lethal in 10% of cases, particularly in young children who cannot survive the mucous buildup in the throat that eventually makes breathing impossible.  The Pasteur Institute developed an antiserum in 1888 that did not prevent disease but lessened its severity and allowed many children to recover during the first two weeks of the infection.  We now have an effective vaccine (DTaP).  A patent was first granted for diphtheria antiserum in the United States 1898.  The Lancet  rejected the notion that the inventor, Emil von Behring of the German chemical company Hoechst, was “entitled to be regarded as the sole discoverer of a method which was the outcome of slow and prolonged scientific investigation and reasoning pursued in all directions.”  Other reactions were less circumspect.  The American Medico-Surgical Bulletin stated that the patent “violates every principle of justice and negate(s) the whole utility of patent law (and) steals from society its just heritage and gives it to an individual…and hinders progress…This…closing of the doors of knowledge will prove serious if not quickly arrested by the profession.”  Indeed.

Finally, the title Owning the Sun comes from Jonas Salk.  The National Foundation for Infantile Paralysis (NFIP) began in 1934 as a direct pipeline from ordinary Americans to scientists in their laboratories working on a vaccine for polio, a largely untreatable disease with some cases more severe than others.  Those of a certain age remember NFIP as the March of Dimes, which was still collecting money one dime at a time in the 1960s.  In 1947 the March of Dimes funded the laboratory at the University of Pittsburgh in which Jonas Salk and his colleagues developed the Salk Vaccine based on killed poliovirus.  Salk was interviewed about the vaccine by Edward R. Murrow on his program See It Now, which was the highest-rated primetime news program at the time.  When asked pointblank by Murrow, “Who owns the patent on this vaccine?” Jonas Salk replied, “The people, I would say.  There is no patent.  Could you patent the sun?” (one-minute video). [11]  No, you couldn’t, but no one would be surprised today at the attempt, especially as geoengineering may become an obligatory experiment during the lives of our children and/or grandchildren.

Where do we go from here?  My goal is to stimulate discussion, not specify a result.  I have previously suggested that we enlarge both NSF and NIH, which we can afford, so that we will not miss the unexpected discoveries that often make the biggest differences.  One can only wonder what was missed when SARS and then MERS were forgotten after their brief appearances in 2003 and 2012.  But unless we figure out a way to spend our wealth on what gives life instead of what takes life, the oncoming crisis that has been called the “Jackpot” here will most certainly be a crisis without a solution.

Notes

[1] The late Mary Midgely (long video) defined scientism in a series of works from the mid-1970s up to her death at the age of 99 in 2018.  This collective biography of four Oxford contemporaries – Mary Midgley, Iris Murdoch, Phillipa Foot, and Elizabeth Anscombe – is a good place to begin.  Yes, I know.  Too many books, not enough time, but this is fun read at 300 pages.  As is the other biography that also came out last year…Moral philosophy as it was meant to be.

[2] Full disclosure: As a member of a publicly funded research group that received additional support from one of the biggest of Big Pharma.  I learned cloning and recombinant DNA techniques at the Roche Institute of Molecular Biology (RIP, the Bell Labs of modern biochemistry and molecular biology) almost 40 years ago before they became totally facile.  I received a few thousand dollars in royalties in the late-1980s through the early-1990s.  All of my independent laboratory research since then has been funded by public and private non-profit institutions as noted in my brief biography at the head of each post.  This probably places me well within the norm of those who did not in the words of PK “cash out with a unicorn.”

[3] Discussion of a public good as non-rivalrous is beyond the scope of this post, but the “intellectual property” that forms the basis of Biomedicine is not real property to be used as the owner sees fit.  This is especially true when biology is compared to chemistry.  Theoretical chemistry is largely a separate matter from what we have come to know as the chemical industry.  Modern chemistry developed commercially in companies large and small, first in Germany in the 19^th century.  A good example from my reading is presented in Mauve: How One Man Invented a Color and Changed the World by Simon Garfield.  William Perkin, who was attempting to synthesize the antimalarial drug quinine, made the signal discovery that led to the aniline dye industry.  BASF is the abbreviation of Badische Anilin- und Soda-Fabrik (Baden Aniline and Soda Factory).  Biology developed as more of a “basic science” in universities and institutions such as the Pasteur Institute, without substantial industrial or commercial support at the foundations.  A recent survey from Aristotle through “systems biology” is A History of Biology by Michel Morange of the Sorbonne.

[4] The staff of Asclepius, a rod wrapped by a single serpent, originated in Sumer.  Medicine was the deliberate art of the temple in Sumer and Ancient Greece and Rome; this extended through the Middle Ages.  The caduceus, a rod with wings and two serpents is the staff of Hermes, the messenger of the gods who is associated with speed and the agora/marketplace.  “That the modern health industry sometimes confuses the two ancient symbols is a poetic and revealing error.”  Yes, it is.

[5] Yes, Medical Ethics has been a changeable thing, eligible for a severe indictment extending into living memory with the Tuskegee Experiment and the “correct” institutional responses to COVID-19, here for example in a link from last Saturday.

[6] As noted by the author, this is the same Alfred Kahn of Cornell University who was Jimmy Carter’s “father of deregulation” in the late-1970s.  One can argue ad infinitum about the demise of regulation in communications, aviation, transportation, and Biomedicine, but to maintain this has been an unalloyed good is absurd, even as it has become political and economic neoliberal gospel.

[7] From p. 145: “The Chicago version of Stigler was a servant of corporate power and embodied neoliberalism’s open animus to majoritarian rule.  At a 1978 meeting of the Mont Pelerin Society , Stigler would recommend ‘the restriction of the franchise to property owners, educated classes, or some such group.’”  Pure music to the ears of the current Professional Managerial Class (PMC), whose made members are neoliberal to the core.  In my reading, The Globalists (2018) by Quinn Slobodian is the best single treatment of the neoliberal project.  His recent Crack-Up Capitalism: Market Radicals and the Dream of a World Without Democracy (2023) is also well worth the read.

[8] From p. 166: “(T)he NIH website defines the CRADA program as ‘an exciting opportunity for NIH investigators to join with their colleagues from industry and academia in the joint pursuit of common research goals.  Government scientists can leverage their own research resources, as well as serve the larger mission of NIH, to facilitate the development and commercialization of healthcare pharmaceuticals and products.  Companies also can leverage their own R&D efforts while collaborating in state-of-the-art NIH research.’”  Word salad for which a close reading would require a week of constant effort.  And when “leverage” is used as a verb, a rodent of the PPP – public-private partnership species – lurks nearby.

[9] That remdesivir did not prove very effective against SARS-CoV-2 is irrelevant.

[10] That the original mRNA vaccines may have protected some from the worst consequences of the first COVID-19 wave while not preventing disease or its transmission is not relevant to the argument.

[11] At 0:55 the vaccine being given to the child is probably the oral Sabin vaccine that supplanted the Salk vaccine in the early 1960s.  No matter.  The polio vaccines are a triumph of modern Biomedicine.  There are two additional points to make about the Salk vaccine.  As presented in this short video, the March of Dimes was a response of the people to a horrific viral disease, spread mysteriously from person to person.  Would the people respond like this today?  I believe the answer is yes, if we had good reason to trust the scientific, medical, and political establishments that rule Biomedicine.  The people had this trust in the middle of the 20^th century.  The other point is the Salk vaccine was based on the killed poliovirus, and no shortcuts were permissible in its exacting preparation.  Nevertheless, something happened, as had been feared by Salk.  From the biography of Jonas Salk by Charlotte DeCroes Jacobs, in which he explained that: “drug manufacturers were entrepreneurs, not academic scientists; they occasionally ignored the ‘Minimum Requirements (of vaccine production) and made cost-saving decisions.”  In this case, if memory serves, the production laboratory centrifuged the vaccine prep to remove formaldehyde-treated virus-containing tissue instead of filtering it.  Some live virus slipped through and caused an outbreak of polio in those who received that lot of vaccine.  But after the problem was identified and corrected immediately and transparently, vaccination resumed mostly without fear.  Imagine that response today.