By MIKE MAGEE

The incoming Trump Administration nominees for positions in Health and Human Services (like RFK Jr. to direct the department and Mehmet Oz to head Medicare and Medicaid Services) are names you know and apparently many trust? In this morning’s New York Times, Dr. Ashish Jha, President Biden’s Covid lead, thinks he knows why. He says, “You have a large swath of the population facing a health crisis, and they feel like medicine and public health isn’t delivering…They’re much more open to people saying, ‘The whole system is corrupt and we have to blow the whole thing up.’”  As Ashish knows better than most, we didn’t arrive here out of the blue. Over the years, many of the players who had the greatest impact on America’s health care system as we know it, remain hidden in the historic shadows. Here (in no particular order) are 10 of the least known but most influential figures in shaping health policy in our lifetime.

Sam Massengill

In spring 1937, the head of sales for S.E. Massengill Company in Bristol, Tennessee, went to the company head, Samuel Evans Massengill, with an idea generated by customer feedback. Massengill salesmen were passing along reports from doctors that there was demand among parents of young children suffering from strep throat for a liquid version of their new sulfa drug.

Massengill, charged the company’s chief chemist, Harold Cole Watkins, to find an effective solvent in which powdered sulfanilamide (an anti-biotic) could be dissolved. His choice was diethylene glycol, which smoothly dissolved sulfanilamide powder and led to a concoction that was 10 percent sulfanilamide, 72 percent diethylene glycol, and 16 percent water. Flavored with raspberry extract, saccharine, and caramel, it passed the taste and smell tests, but in keeping with then current federal regulations—or lack thereof—there was no test for safety. In fact, no one did even a rudimentary check of the literature on diethylene glycol, which would have quickly revealed that it was a highly toxic component of brake fluid, wallpaper stripper, and antifreeze that had caused a fatality in 1930.

Instead, perhaps sensing that its competition would be right behind, Massengill rushed its “Elixir Sulfanilamide” into production, then shipped 240 gallons of the red liquid to 31 states through a network of small distributors in early September 1937.

Within two weeks, children began to die. In all, more than 100 children died, but only after going through 7 to 21 days of wrenchingly painful illness including “stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions.”

The whole disaster was vigorously reported in the press, and drug safety soon inched its way up the list of New Deal priorities. By June 11, 1938, bills from the Senate and House of Representatives had been reconciled, and on June 25, 1938, President Roosevelt signed into law the 1938 Federal Food, Drug, and Cosmetic Act.

Samuel Massengill belatedly issued a statement on behalf of his company: “My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. . . . I do not feel there was any responsibility on our part.” Unfortunately, Massengill’s morally blind position reflected the letter of the law at that time. In short, the absence of effective legal sanctions meant that a company or an individual could indeed sell a deadly medication and get away with it.

Mary Lasker

Born in 1900, Mary Lasker was the daughter of Frank Elwin Woodard, the head of the local bank in Watertown, Wisconsin, and a shrewd businessman with Chicago connections. By her own account, she was a campaigner almost from birth, and she traced her interest in promoting medical research back to an event she experienced at the age of three or four. Her mother, a local community supporter and civic activist, took Mary to see their ailing servant, a Mrs. Belter, who had undergone a double mastectomy as treatment for breast cancer. “I thought, this shouldn’t happen to anybody,” Mary Lasker later wrote.

As a young adult, she began to focus on health policy issues and became a devotee to Margaret Sanger. Mary sought out financial support for the organization, turning to a dynamic advertising man, Albert Lasker, who had launched some of America’s most recognizable consumer brands, including Lucky Strike cigarettes. Known as the “father of modern advertising,” Lasker is credited for suggesting that the Control Federation of America be renamed the Planned Parenthood Federation.

When Albert asked Mary what she wanted to accomplish, she listed reforms in health insurance, cancer research, and research against tuberculosis. Albert responded, “Well, for that you don’t need my kind of money. You need federal money, and I will show you how to get it.”

When Mary and Albert married in 1940, the world was preparing for war.

Beginning in 1942, the Laskers began to cultivate science luminaries who shared their commitment to maximizing government funding of applied research. The Laskers realized early that they would need a credible health-related national organization to anchor and launch their campaign and set their sights on the American Society for the Control of Cancer, an organization created in 1913 by 10 physicians meeting at the Harvard Club in New York City. The leadership was more than happy to grant the Laskers easy entry to their Board of Trustees in return for financial support. By 1944, the Laskers had seized control of the Board, largely dumped the doctors, and renamed the group the American Cancer Society (ACS). Its leadership was now composed of name-brand corporate heads, entertainment giants, and advertising executives.

To add further glory to the idea of Big Science, Mary and Albert created the annual Lasker Awards, with the somewhat self-serving tagline “Sometimes called ‘America’s Nobels.’” She then began to collect academic researchers, promote their careers, injecting publicity and special placement on government bodies. Over a decade she was at the center of creating seventeen specialty Institutes within the new NIH, most built around her favored scientists.

Mary Lasker died in 1994, a controversial figure.In the assessment of author and political journalist Elizabeth Drew, “Mrs. Lasker has been considered an able woman who has done good things but is too covetous of power, too insistent on her pursuits, too confident of her own expertise in the minutiae of medicine.”

William Menninger

During the first major WW II battle in North Africa, a startling number of soldiers were incapacitated with “Shell Shock.” One neurologist in North Africa, Frederick R. Hanson, discovered that a bit of kindness in the form of a hot shower and a warm meal, combined with sedation-induced rest, was remarkably successful in rehabilitating the majority of the “mentally incapacitated” men under his care.

Hanson’s success did not go unnoticed by the Army’s chief of the division of neuropsychiatry in the Office of the Surgeon General, William C. Menninger. After studying his results, he decided that if psychiatric casualties in a standard unit exceeded one mental casualty for every four wounded in action, this was a harbinger of broader problems—like a breakdown in morale, leadership issues, prolonged combat fatigue, or a policy breakdown in the evacuation scheme.

Other observations included the fact that new units with limited combat experience had a higher percentage of mental casualties then seasoned units did, and that the medical officers in these units were more inclined to ship out those with “normal fear reactions.” On the other end of the spectrum, troops that exceeded 12 months of combat exposure began to experience a higher percentage of mental casualties.

The experience in North Africa had clarified for Army Chief of Staff, General George Marshall, that the plan for handling neuropsychiatric casualties in the field was seriously broken. At his request, Menninger came up with a plan that included psychiatric support close to the battlefield, reinforced by the heavy and liberal use of barbiturates and ether anesthesia if necessary for initial sedation of hysterical soldiers. In the most severe cases, other experimental treatments would be used, such as intravenous sodium pentothal, a.k.a. truth serum, to draw out (and ideally remove) the troubling traumatic memories of war.

Menninger immediately realized there were not nearly enough psychiatrists to execute the plan, so he came up with the idea to train a portion of the medical officers in what he called “forward psychiatry.” These officers were subjected to a 30-day immersion course to master Menninger’s system and make them comfortable with the liberal use of barbiturates. They were thereafter labeled “30-day wonders.”

Menninger’s plans were encoded in a diagnostic manual, Medical 203 (which was the basis of the Diagnostic and Statistical Manual of Mental Disorders, or DSM, released shortly after the war). Today, the bible of mental health, and now in its fifth edition, the DSM-5 is a structured approach to the diagnosis and treatment of mental illnesses, including the use of those wartime barbiturates and the many chemical children they spawned.

The pharmaceutical industry responded to all these developments with an aggressive search for “blockbusters” to capture the expanding market. Some of these new medicines were designed to treat very real ailments; in other cases, the drug came first, after which the drug company’s newly energized marketing teams developed a problem for it to solve. By 1960, one out of every six American adults was being treated with pharmaceuticals for anxiety.

Hans Selye

In the early 1950s, Reader’s Digest published a ground breaking article titled “Cancer By The Carton”, informing the public that cigarettes caused lung cancer. As part of the fallout, the AMA eliminated cigarette advertising from their medical journals.

To continue selling cigarettes in the face of devastating scientific evidence of tobacco’s link to lung cancer was challenging enough, but newer evidence was beginning to reveal that the habit also led to deaths from heart attacks. The companies had to come up with an alternate explanation for the rise in cardiac deaths that clearly tracked the rise of cigarette sales.

Their savior was a Hungarian-born endocrinologist named Hans Selye, a man nominated multiple times for the Nobel Prize. Selye was famous for his formulation of the concept of stress as the source of microscopic injuries to the cell. But he was also known for his ability to attract research funding, which was enhanced by his willingness to tailor the evidence to suit the highest bidder.

In numerous court cases during the 1960s and 1970s, the Tobacco Industry Research Council relied on Selye as an expert witness to make the argument that smoking, rather than being a health hazard, might actually provide a measurable benefit in the form of stress relief. Meanwhile, Dr. Selye was turning to the tobacco industry for major grants to support his growing research enterprise and to enrich himself.

Years later, as part of document disclosure during litigation by state attorneys general against the tobacco industry, communications between Selye and industry representatives proved that he had conspired to hold back supportive testimony and publications suggesting a link between tobacco use and stress reduction until he received his cash.

When Hans Selye died in 1982, he was regarded as a venerable scientist, but the tobacco industry’s funding of his work, and Selye’s willingness to recruit additional scientists to present tobacco’s messages in meetings and publications, was later cited by the US Department of Justice as a clear example of racketeering.

Lemuel Boulware

When the AMA began to look for someone to help fight the scourge of socialized medicine in 1960 Ronald Reagan was the ideal public opinion operative.  His training as a politician and public communicator lasted 10 years and was directed by Lemuel Boulware, who had served as Roosevelt’s operations vice chairman of the War Productions Board, and then moved on to one of the military’s largest suppliers, General Electric.

At GE Boulware had a philosophy of “going over the heads” of union leaders. Instead of confrontation, he employed comprehensive, ongoing communications and economic education directed not only at workers at all levels in his organization but also at their spouses and families. He fostered newsletters, symposia, book clubs, and courses that included a heavy dose of basic conservative economics, but they also touched on entrepreneurship, management philosophy, investment, retirement, health, and family education.

The new medium of television was becoming a factor in American life, so Boulware decided to launch a new TV show called General Electric Theater. He turned to Ronald Reagan to host the weekly dramatic series. Over the next eight years, Reagan visited and addressed more than 250,000 GE employees and customers at 139 different GE sites, perfecting what came to be known as “The Speech.” The AMA hired Reagan on GE’s recommendation. Reagan’s speech and its’ views on Medicare aligned with those of the AMA, but they came out of GE, thanks to his mentor, Lemuel Boulware.

Edward Annis

On May 20, 1962 at Madison Square Garden in New York City, President Kennedy delivered a major address on health care to a full house of 20,000 senior citizens. The speech was broadcast without advertising by all three major networks as a “news event,” and it reached an estimated viewership of 20 million. He directly challenged the AMA and its health care lobbyists, who were flooding the hallways and mailrooms of Congress.

The AMA was livid. It demanded equal time from the networks to give a formal response to what they saw as a Democratic Party political address, but it was refused. Undaunted, the AMA board gave the go-ahead to rent Madison Square Garden and pay to televise their rebuttal.

As their voice, they chose a Tallahassee surgeon, Dr. Edward Annis, who had been a debater in high school and college. Part of the AMA speakers’ bureau, Annis, like Ronald Reagan, had been put on the road the year before to develop his own version of Reagan’s “speech.” He had delivered it dozens of times over the past five months and along the way had publicly debated UAW officials and Senator Hubert Humphrey.

When he got to Madison Square Garden on May 22 to deliver a very personal rebuke to the president, Annis had two advantages. President Kennedy’s earlier address, as his staff would later admit, was not his best. The AMA also had Kennedy’s speech on film and was able to build a point-by-point reply.

Dr. Annis, in 30 minutes, mined the weaknesses of Kennedy’s address, referencing filmed portions of the president’s speech, and challenged the absent president directly as he went along. At the end of the speech, Annis admonished Kennedy:“The people have a right to remind their first servant that his election, even his present popularity, does not authorize him to change fundamental institutions that have proved a lasting value through the generations…There are few such things that touch so close to God. And the relationship between a doctor and his patient is one of them…To the millions of Americans who may have a doubt, who may want to take a moment to hear the views of one they know and trust, I implore you, ‘Ask your doctor. Ask your doctor.’”

And ask they did, in droves. The AMA’s paid televised address on the same networks Kennedy had accessed two days earlier was said to have reached 30 million viewers. On July 17, 1962, the health care bill went down in defeat in the Senate by a vote of 52–48.

Ed Pratt

In the 1980’s Pfizer CEO Ed Pratt was ideally positioned to lead the global charge on intellectual property (IP) protections. Pratt was chairman of the powerful US Business Roundtable and also the formal adviser to Reagan’s US trade representative, Bill Brock.

Pratt’s first move was to form a task force on intellectual property with his chief ally, IBM CEO John Opel. Their recommendation to Brock that a position be created within the Office of the US Trade Representative for a director of international investment and intellectual property sailed through.

Pratt also directed the creation of the Intellectual Property Committee (IPC) of the powerful US Council on Business. This provided a platform for the next step in organizing a global effort. In 1983, Pratt and Opel approached the leaders of 10 other large US-based multinationals, including General Electric, General Motors, DuPont, Johnson & Johnson, and Monsanto, requesting their participation on the Intellectual Property Committee and creating a united front across industries.

At Bill Brock’s request, Pratt, built a multi-sector global coalition of major corporations to engage the United Nations and World Trade Organization. Domestically, he worked the chambers of commerce, business councils, business committees, and trade associations. Pfizer executives, who occupied key positions in strategic business organizations, were directed to engage with their cross-sector colleagues in every industry.

Pratt persisted for over a decade until he won. As a direct result of his IP wins, pharmaceutical companies in the U.S. gained up to 20 years of patent protection for new drugs approved by the FDA. In addition, the integrated internal public affairs team he created inside Pfizer for the project became the prototype for PhRMA’s subsequent “government relations on steroids” and the under-pinning for the integrated and strategic cross-sector 21st century Medical Industrial Complex.

Louis Lasagna

In 1970, Lou Lasagna MD 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.

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.

He laid the statistical groundwork to “prove” that the pharmaceutical industry was “high risk/high gain.” Lou 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. Multiplied by the average approval time required for a new drug application—31 months—that added up to real money.

Lasagna labeled the problem as America’s “drug lag” and positioned himself and his fellow physicians as friends of the industry. For individual drugs, in 1980 Britain beat the US to the market for new drugs, on average, by two years. At the time, the country was in a stubborn recession. Lasagna argued that the cost of drug innovation was way too high, and that part of the problem was government ownership of any discoveries that had been funded with NIH grants.

As a brilliant strategist, Lasagna could see a number of these issues breaking his way. The stubborn recession combined with the escalating cost of employer-based health benefits was beginning to fuel the demand for innovative solutions. Lasagna was skilled at converting concern about cost into demands for efficiency and less regulation of industry. He successfully led the charge to release government patents back to medical scientists and their institutions. A decade later, the HIV/AIDS epidemic would push massive liberalization of drug approval over the line, and Lasagna would be the director of the government’s expert committee with a young researcher, Anthony Fauci as his NIH ally.

Paul Weyrich

in 1970, a Nixon-era journalist named Paul Michael Weyrich arrived on the political scene.  A staffer at the Milwaukee Sentinel who served as a weekend anchor at the local ABC affiliate WISN-TV, Weyrich went on to serve as press secretary to Colorado senator Gordon Allott. From there it was a short walk to the offices of conservative beer mogul Joseph Coors, who was funding the creation of a new right-wing think tank called the Heritage Foundation. Weyrich became its first director, and he summed up his mission this way: “The New Right is looking for issues that people care about. Social issues, at the present, fit the bill.”

Over the next decade, working with televangelists Jerry Falwell and Pat Robertson, they together fashioned Christian white nationalists into a political body, “The Christian Right”, and helped elect Jimmy Carter. When Carter was unwilling to oppose Roe v. Wade and homosexuality, they mobilized in support of Reagan and what they now termed “The Moral Majority.” Four decades later, with the Dobbs decision, their dream came true.

Linda Robinson

In 1997, at the age of 44, Linda Robinson was already a legend in the field of Crisis Communications on Wall Street. Well known for her role in the leveraged buyout of RJR Nabisco, the story at the center of the book and film “Barbarians at the Gate”, she had been featured in a 10-page cover story in Vanity Fair. This piece described her as “the most powerful public relations broker in the country.”

Her husband, James D. Robinson III, was the chairman of American Express, and she was on first-name terms with most of the major players in media and politics in New York City. Her father, Freeman Gosden, had been a radio personality (Amos of Amos ’n’ Andy) and a longtime Hollywood fixture close to many political figures, including Ronald Reagan. When Reagan entered the 1980 presidential race, Linda became assistant to the campaign’s press secretary. After Reagan’s victory, she became press secretary to the secretary of transportation just as America’s air traffic controllers went on strike, and the showdown between them and President Reagan became one of the lead stories of the year.

In the mid-1990s, Pfizer CEO Bill Steere was ramping up to support a product that he already knew would become infamous, Viagra.  He knew it would unleash a huge public debate, and he was focused on identifying every possible issue or public challenge that might arise. In short, he wanted to be prepared and avoid a crisis. So he quite naturally turned to Linda Robinson to head up Pfizer’s secret, internal Viagra Advisory Board filled with ethicists, theologians, sex therapists, scientists and representatives of four of the largest public relations firms in New York, including her own company: Robinson Lerer & Montgomery. This was a full 18 months before the drug was slated to be approved.

Robinson embedded her own staff at Pfizer headquarters at 42nd and 2nd Avenue, and ran the Viagra “War Room” for the first 12 months after approval until the product’s success was assured. Rather than dismantle the team, it was then repurposed as Robinson and her people helped direct the successful “hostile takeover” of Warner Lambert. The prize? Lipitor, the statin drug, which by 2010 was the first drug ever to exceed $10 billion in annual sales.

Mike Magee MD is a Medical Historian and regular contributor to THCB. He is the author of CODE BLUE: Inside America’s Medical Industrial Complex. (Grove/2020)

Categories: The Business of Health Care

Tagged as: Ed Pratt, Edward Annis, Hans Selye, Lemuel Boulware, Linda Robinson, Louis Lasagna, Mary Lasker, Mike Magee, Paul Weyrich, Pfizer, Sam Massengill, Viagra, William Menninger

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