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Ten Shadowy Figures Who Shaped Our Health Care System

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.

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Pfizer’s Biotech Strategy: When a “Market Force” Partners with a “Market Mover”

by JESSICA DAMASSA, WTF HEALTH

The synergistic relationship between biotech’s and biopharma’s can dramatically change the way new drugs and vaccines are bought to market – helping advance innovation on BOTH sides in a very mutually beneficial way. I’ve got an inside look at how Pfizer is working with emerging biotech start-ups, thanks to this in-depth chat with Pfizer’s Senior Vice President of Business Innovation, Kathy Fernando.

Kathy is not only responsible for developing relationships with biotech’s on behalf of Pfizer, BUT during the pandemic she led Pfizer’s mRNA scientific strategy, which was integral to its ability to rapidly develop the Covid-19 vaccine. We geek out on the “cool science” that mRNA is – AND the new platforms that biotech’s are bringing to the table – and talk about the impact both are making on the business of Big Pharma, the hot biotech investment space, and, most importantly, patients.

We also get into a bigger conversation about innovation in the Life Sciences industry – with great insights that can be extended to the rest of healthcare quite easily. I ask point blank: Pfizer is a gigantic, global biopharma company…Why wouldn’t it do these types of innovations internally, in-house themselves? Why partner outside?

Kathy explains the magic that is unlocked when a “market force” partners with a “market mover” for the sake of innovation, and the lessons learned are far reaching and applicable no matter where you are in health innovation.

How is Pfizer looking at new models for collaborating with biotech companies? What are the key characteristics of Pfizer’s culture of innovation that have newly emerged or deepened as a result of their work on the Covid vaccine during the pandemic? We dive deep into the biopharma-biotech model and all it brings in terms of new science, breakthrough therapies, and brand-new business opportunities. Watch now!

The Future of Clinical Trials at Pfizer

BY JESSICA DaMASSA

From de-centralized clinical trials to real world data (RWD), real world evidence (RWE), and even social media, the future for clinical research at Pfizer sounds increasingly tech-enabled and focused on meeting and engaging patients where they are.

Pfizer’s Head of Clinical Trial Experience, Judy Sewards, and Head of Clinical Operations & Development, Rob Goodwin, drop in to chat about what Pfizer’s approach to clinical research looks like now, after the rapid evolution it underwent to “lightspeed” the development of the Covid-19 vaccine.

The big change? Rob says they are “obsessed” with de-centralized trials, with nearly 50% of clinical trial visits still happening virtually. And, beyond the convenience factor, both point to de-centralization as a critical factor in being able to recruit more patients into trials as well as improve the diversity of their participant groups. In the end, the decentralized approach, says Judy, is “not just a matter of equity, but good science as well.”

And what about improvements to the cost of drug development? Is it too soon to tell if de-centralization will make an impact on the bottom line? Innovation may be expensive to implement at first, but, explains Rob, “If you can recruit your trial faster, overall, the cost of development goes down and speed to the patient goes up.”

We chat through the full suite of benefits that de-centralized clinical trials are bringing Pfizer and its patient populations, and get into the utility of real-world data, which also saw new notoriety when the Covid-19 vaccine was being developed. How is RWD impacting clinical research even when it’s not being used as evidence in a regulatory approval process? Watch and find out more about how data innovation is shaping the future of pharma!

Digital & Tech Are Changing Pfizer: Pharma Co’s Chief Digital & Technology Officer Takes Us Inside

By JESSICA DaMASSA, WTF HEALTH

What does digital transformation look like at a global healthcare giant like Pfizer? Lidia Fonseca, Pfizer’s Chief Digital & Technology Officer, shares her strategy for building the life sciences company’s digital data and technology solutions, including her thinking about digital therapeutics, digital diagnostics, and digital biomarkers. As Lidia puts it, this is not about trying to simply implement a “digital strategy,” but is, instead, about building a “business strategy for digital world.”

There’s probably no better story that illustrates how that “business strategy for a digital world” is playing out than the fascinating example of how Pfizer’s Digital team helped accelerate the development of the Covid19 vaccine and oral treatment. Lidia takes us inside and talks through how her team used tech to safely speed-up everything from development timelines to clinical trials and even go-to-market in areas around the globe that were experiencing outbreaks.

Beyond the tech team’s ability to effectively wield data that changed the game when it came to Covid, Lidia also shares what’s next for the pharma co when it comes to digital health and digital medicines. Beyond the pill? Around the pill? Instead of the pill? What’s Pfizer’s position on digital therapeutics as it continues to work to bring new breakthrough medicines to patients? We get into all the ways digital and technology are manifesting themselves within an organization like Pfizer AND get Lidia’s best advice for other healthcare organizations who are redefining their businesses with technology.

The “Secret Sauce” – A Comparison of TSMC and Pfizer

By MIKE MAGEE

This week’s Tom Friedman Opinion piece in the New York Times contained a title impossible to ignore: “China’s Bullying Is Becoming a Danger To The World and Itself.” The editorial has much to recommend it. But the item that caught my eye was Friedman’s full-throated endorsement of Taiwan’s “most sophisticated microchip manufacturer in the world,” Taiwan Semiconductor Manufacturing Company (TSMC).

TSMC owns 50% of the world’s microchip manufacturing market, and along with South Korea’s Samsung, is one of only two companies currently producing the ultra-small 5-nanometer chips. Next year, TSMC will take sole ownership of the lead with a 3-nanometer chip. In this field, the smaller the better. (For comparison, most of China’s output is 14 to 28 nanometers.)

U.S. Silicon Valley companies like Apple, Qualcomm, Nvidia, AMD, and recently Intel contract with TSMC rather than produce chips on their own. In addition, the key machines and chemicals necessary to produce the chips are willing supplied to TSMC by U.S. and European manufacturers. TSMC’s secret sauce, according to Friedman, is “trust.” As he writes, “Over the years, TSMC has built an amazing ecosystem of trusted partners that share their intellectual property with TSMC to build their proprietary chips.”

“Trust me” is not a phrase often associated with intellectual property. Consider, for example, Washington Post’s reporting the very same day as Friedman’s under the banner, “In secret vaccine contracts with governments, Pfizer took hard-line in the push for profit, report says.” The article reveals documents in a Public Citizen report that confirms that Pfizer has been maximizing their vaccine profits “behind a veil of strict secrecy, allowing for little public scrutiny… even as demand surges…”

As I describe in my book “Code Blue: Inside the Medical Industrial Complex” (Grove 2020), Pfizer’s focus on intellectual property as a commercial weapon has a history that extends back a half-century.

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Pfizer Pioners New Ways to Frustrate Generics

The best-selling drug in pharmaceutical industry history, Pfizer’s cholesterol-lowering Lipitor, lost its patent protection Thursday. But the huge savings that consumers, insurance companies and the government usually realize when generic versions of a best-selling pill hit the market are still six months away, and, consumer advocates fear, may never come to pass.

The reason is the unprecedented series of side deals that Pfizer has signed in recent months with some insurers and pharmacy benefit managers to offer lower-priced versions of Lipitor, known generically as atorvastatin. They also are offering consumers $4 co-pays – comparable to prices paid at discount outlets like Walmart and Costco – so they’ll continue buying the brand name version of the drug.

Government officials fear the full cost of the drugs might then be passed along to insurers and Medicare, although the companies involved say that won’t happen.

The goal of the maneuvers is to keep as many of the estimated 8 to 10 million Americans who take Lipitor ($7.2 billion in U.S. sales in 2010; $10.7 billion worldwide) on either the branded product or on an “official” generic, which in Lipitor’s case will be marketed by Watson Pharmaceuticals. They will sell for about half the price of the branded product for about six months, when a number of generic makers are expected to hit the market. Their versions of atorvastatin could sell for as low as $50 a month, which is less than a tenth its current price and comparable to other generic statin drugs already on the market.

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Saying No to the Drug Crisis

By BRIAN KLEPPER

In a recent essay, VIVIO Health’s CEO Pramod John guides us through four sensible drug policy changes and supporting rationales that could make drug pricing much fairer. Reading through it, one is struck by the magnitude of the drug manufacturing industry’s influence over policy, profoundly benefiting that sector at the deep expense of American purchasers. As Mr. John points out, the U.S. has the world’s only unregulated market for drug pricing. We have created a safe harbor provision that allows and protects unnecessary intermediaries like pharmacy benefit managers. We have created mechanisms that use taxpayer dollars to fund drug discovery, but then funnel the financial benefit exclusively to commercial interests. And we have tolerated distorted definitions of value – defined in terms that most benefit the drug manufacturers – that now dominate our pricing discussions.

The power of this maneuvering is clear in statistics on health industry revenues and earnings. An Axios analysis of financial documents from 112 publicly traded health care companies during the 3rd quarter of 2018 showed global profits of $50 billion on revenues of $636 billion. Half of that profit was controlled by 10 companies, 9 of which were pharmaceutical firms. Drug companies collected 23% of the total revenues during that quarter, but retained an astounding 63% of the profits, meaning that the drug sector accounts for nearly two-thirds of the entire health care industry’s profitability. Said another way, the drug industry reaps twice the profits of the rest of the industry combined.

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Three Reasons AstraZeneca Were Right to Reject Pfizer

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The transatlantic stand-off between the two pharmaceutical giants, Pfizer and AstraZeneca, is over; possibly for good. With Pfizer having failed to conclude a £69bn deal with the British-Swedish multinational pharmaceutical firm, almost £7bn was wiped from AstraZeneca’s share value.

AstraZeneca’s board, which decided that Pfizer’s bid was inadequate, has subsequently been criticised by major shareholders for “failing to engage”. Pfizer meanwhile, has been accused of being driven purely by the lure of lower taxes, job cuts and budget reductions. We have rounded up the reasons why we think that Astra Zeneca were right to reject the takeover bid from Pfizer.

Jobs Threatened

The proposed takeover had major implications for several sectors. From major health and pharmaceutical recruiters to manufacturers and research companies, all would have been affected by Pfizer’s huge takeover bid. Despite repeated initial assurances from Pfizer’s CEO, Ian Read, both AstraZeneca and Pfizer finally acknowledged in last week’s parliamentary select committee meeting that there would be cuts to both jobs and research.

Indeed, even before the failure of the bid, many academics, scientists and even union leaders were accusing Pfizer of being driven purely by the possibilities of a lower taxes and reductions to the research budget. Pfizer had already been described by a former boss of AstraZeneca as a “praying mantis” ready to “suck the lifeblood out of their prey”.

However, AstraZeneca’s current chairman, Leif Johansson said that the deal represented “a significant risk to shareholders.”

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