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Metabolical Chapter 6. Because Big Pharma Was Their Teacher
Author: Robert H. Lustig Publisher: New York, NY: HarperCollins Publishers Publish Date: 2021-5-4 Review Date: Status:📚
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Most medical pundits consider the Flexner Report a watershed in the evolution of evidence-based medicine. Throughout the nineteenth century, US medicine was akin to the Wild West. Anything went, snake oil was a big seller, cocaine and heroin were available without prescription, and there was a panoply of medical colleges across the country with fluid curricula and no standardization. In addition, the end of the nineteenth century saw the creation of two alternative branches to challenge traditional medicine—osteopathy, which believed in a holistic approach to the patient; and chiropractic, which believed that many diseases came from disorders of the spine. At the same time, Johns Hopkins School of Medicine in Baltimore was trying to reform itself with rigor into a beacon of evidence-based medicine and science, by adopting the German hierarchical learning pedagogy. At the top of each lab there was Herr Professor, and everyone else was an underling and therefore expendable (Rockefeller University adopted the same organizational structure).
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It was against this backdrop that the nine Flexner children of Louisville, Kentucky (seven boys and two girls), came to the fore. In Jewish families of the time, you were either educated, or religious, or in some cases both. There were no slouches in the Flexner household, but this story focuses on the brothers Simon and Abraham. Abraham got his undergraduate degree after two years at Johns Hopkins, where he was exposed to this German academic paradigm. He readily adopted it and put this organizational structure into practice when he opened his own college preparatory school back in Louisville. Abraham did quite well both administratively and financially, and used his knowledge of education and running a school to write a seminal work denoting the flaws in American higher education, entitled The American College: A Criticism (1908).
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Abraham made enough money as an educator to send his pharmacist brother, Simon, back to medical school, and afterward urged him to move on to postgraduate work at Johns Hopkins. And so Simon was also indoctrinated into the German system and received training to become a pathologist, bacteriologist, and researcher. His mentor was the iconic Canadian physician and chairman of medicine Sir William Osler, the creator of the residency program system for young physician trainees (note the German hierarchical paradigm here as well). Simon was a favored son, and Osler eventually secured him a faculty appointment in pathology at the University of Pennsylvania.
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That might have been as far as it went for the Flexners, but for a dash of serendipity combined with a splash of avarice. In the late 1800s Baptist minister Frederick Gates befriended Baptist philanthropist John D. Rockefeller, and in 1892 they founded the Baptist University of Chicago (which has since become nonsectarian). Gates became Rockefeller’s business advisor, who continued to help rehabilitate his cutthroat business reputation through strategic philanthropy, similar to Andrew Carnegie, and not much different from what is seen by people like Bill Gates (no relation) and Mark Zuckerberg today.
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In the summer of 1897, Frederick Gates, a voracious reader, read Osler’s The Principles and Practice of Medicine (1892). Seeing the disarray in the US medical profession, he believed that American medicine needed some of the same discipline Rockefeller brought to Standard Oil, and prodded Rockefeller to provide the funds to start his eponymous medical institute. Rockefeller was hardly a progressive, and believed in folk medicine as cure. But he also believed in money.
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Standard Oil had an untapped asset/liability—coal tar, a by-product of coal mining and oil refining. Medical practitioners of the day used various preparations of coal tar to treat numerous proliferative skin diseases such as eczema and seborrhea (short-term treatment with coal tar is still occasionally used for this purpose). Rockefeller had product to push, and he needed to create a mass market—so he founded the Rockefeller Institute to engage in medical research so long as it researched the benefits of coal tar. It was up to Gates to find its first director. He contacted Osler directly, who recommended Simon Flexner. The institute opened for business in 1901, and Simon, namesake of Flexner Hall, assumed the helm in 1903.
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But Rockefeller was just getting started—in the drug business, that is. Aside from the Rockefellers, the next biggest shareholder in Standard Oil was German chemical conglomerate IG Farben, best known for creating Zyklon B, the nerve gas used in Auschwitz. By the early 1900s, Farben had developed a successful pharmaceutical industry, with drugs such as aspirin, salvarsan (an arsenic compound used for syphilis), and novocaine. Rockefeller saw yet a new drug opportunity and untapped market—but he also saw that American physicians didn’t know about these new pharmaceuticals, in part because they didn’t learn about them in medical school. Rockefeller needed distributors to sling this product, and so green-lighted a project to completely evaluate the American medical school system in order to dismantle it and reformulate it to focus on medical research and drug therapy.
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Who should spearhead such an evaluation? How about an educator who believed in the German system? Simon nominated his brother Abraham. An easy sell, as Henry Pritchett, chairman of the Carnegie Foundation, had read The American College. The last vote came from the American Medical Association, who stood to rid themselves of pesky alternative therapy schools and would become the regulatory body for medical education going forward. These American oligarchs “embraced scientific medicine as an ideological weapon in their struggle to formulate a new culture appropriate to and supportive of industrial capitalism.”
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Never mind that Abraham himself knew nothing about medicine—after all, physicians were the problem, right? To bone up, he spent two years evaluating the organizational structure of several European medical schools, including those in England, France, and Germany. In 1910, Flexner published his Flexner Report, which decried the state of American medical education for lack of evidence-based medicine (the same cry we hear today, by the way), and advocated for far-reaching reform in the training of doctors.
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Flexner doubted the scientific validity of all forms of medicine other than those based on research; everything else was quackery and charlatanism. To be fair, much of it was. Medical schools had to drop electromagnetic field therapy, phototherapy, physiomedicalism, naturopathy, homeopathy, and several other questionable practices. And, most important, nutrition went AWOL. Neither Flexner brother ever embraced the concept of diet or nutrition as part of the new medical curriculum because there was no money to be made in it (to its credit, by the 1970s Rockefeller University did eventually agree that nutrition was important; two of my personal heroes were full professors there—Edward “Pete” Ahrens studied lipids, and Jules Hirsch studied obesity).
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The Flexner Report of 1910 pissed a lot of people off. It led to the closure of most rural medical schools and complementary and alternative therapy schools. In particular, his report helped close all but two African American medical colleges, because in his view, “The practice of the Negro doctor will be limited to his own race, which in its turn will be cared for better by good Negro physicians than by poor white ones… . The Negro must be educated not only for his sake, but for ours. He is, as far as the human eye can see, a permanent factor in the nation.” Perhaps this was because the AMA was segregated, and had no plans on integrating? Hmmm …
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African Americans weren’t the only ones who were unhappy with the Flexner Report. Eighty percent of medical colleges nationally were forced to shutter for either not meeting standards or not overhauling their curricula. The osteopathic and chiropractic schools were directly in the crosshairs, and while they protested, there wasn’t much that could be done. The fix was in.
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Although almost all the alternative medical schools listed in Flexner’s report were closed, the International Association of Chiropractic Schools and Colleges (IACSC) was formed, with nineteen member colleges. The American Osteopathic Association (AOA) also brought a number of osteopathic medical schools into compliance with Flexner’s recommendations to produce an evidence-based practice. The curricula of DO- and MD-granting medical schools are now nearly identical, except that osteopathic schools still teach osteopathic manipulative medicine (OMM).
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If osteopathy was flawed and dangerous to patients, why are osteopathic schools still thriving? From 2010 to 2016, the number of actively licensed DOs in the US increased by nearly 40 percent, from over fifty-eight thousand to over eighty-one thousand (in my clinical retirement, I teach weekly at Touro University California, a Jewish osteopathic medical college. I can state from experience, DO students are as research-focused as their MD student brethren—the big difference is that DO students are devoted to studying the whole patient, not just the diseased organ. Oh, and they get “Food as Medicine”).
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Rockefeller, Pritchett, and the AMA presented the Flexner Report to Congress in 1911, which adopted it without change. Since then, it’s never been updated. The report aligned well with Flexner’s strategy, the AMA’s strategy, Johns Hopkins’s striving for preeminence among major American medical schools, and the quest for new drugs that could advance the nascent pharmaceutical industry’s (and Rockefeller’s) objectives.
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Science is a tool; it’s neither good nor bad. Such value judgments depend on the user. Science should and must be promoted, as it’s a primary driver of societal advancement. However, it’s also clear that the overtly political nature of the Flexner Report, and the effort of Big Business, Big Pharma, and now Big Medicine to capitalize on it, has left a big hole in the profession, which keeps expanding and threatens to engulf us all.
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Big Pharma has exacted some major victories, like antibiotics (although even that claim is now tenuous, see Chapter 2). But one thing you can’t argue with is their profit. Big Pharma’s top eleven corporations have generated net profits on the order of 85 billion in just that one year (and that’s net, not gross). That’s a lot of pills—and more each year. The majority of these largest pharmaceuticals are headquartered in the US—including the top four: Johnson & Johnson (#39 on the Fortune 500 list), Pfizer (#51), Merck (#65), and Eli Lilly (#129), along with Abbott (#152) and Bristol Myers Squibb (#176). American sales of prescription drugs were 1.2 trillion in 2018. With that kind of obscene money to throw around, what Big Pharma wants, Big Pharma nearly always gets.
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And they aim to keep it that way. Experts say the industry contributes about two-thirds of the FDA’s budget, so the government has little impetus to impugn them. Big Pharma also employs a small army of 1,378 lobbyists to spread its influence on Capitol Hill. And they’re great peddlers. Every single drug company spends more on marketing than on research and development. Some, like Johnson & Johnson, spend double their R&D budget on marketing. The rest of the top ten (Novartis, Pfizer, Roche, Sanofi, Merck, GlaxoSmithKline, AstraZeneca, Eli Lilly, and AbbVie), in the years between 1997 and 2016, doubled their annual marketing budget as well, from 30 billion. Schmoozing doctors went from 20 billion, while direct business-to-consumer advertising increased fourfold (from 9.6 billion). For every 19 on promotions and advertising.
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The hidden business model of Big Pharma is to turn one drug into many—by turning out minor variations that extend patent life; and through clinical trial administration, research publication, regulatory lobbying, physician and patient education, drug pricing, advertising, and point-of-use promotion to create distinct bio marketing profiles and brand loyalty for otherwise similar products. Why? Because generic drugs are cheaper; by slightly tweaking their ingredient list, they get more time on patent protection. Hey, if it didn’t work, you know they wouldn’t be doing it.
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Despite all of its successes, only 28 percent of Americans have a good opinion of Big Pharma. In fact, Big Pharma is the third most hated industry in America, after tobacco and petrochemicals. Perhaps the reason they’re both so successful and hated is because they’re treating the symptoms of disease, not the disease itself (see Chapter 1). There are more and more people with more symptoms to treat. They’ve altered their portfolios to invest money and effort into chronic therapies (that you’ll be on for twenty to thirty years) that are palliative, rather than acute therapies that are curative (like one week).
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Nowhere is this exemplified better than in Big Pharma’s response to the coronavirus, because vaccines don’t generate enough profit. The US government initially entertained eighty-nine separate proposals to develop a vaccine. A total of seventy-seven came from universities. Of the hundreds of US pharmaceutical firms, only twelve submitted proposals. Does Big Pharma not do virology?
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As the world’s life span has been expanding consistently over the last one hundred years due to public health improvements and antibiotics, so has the number of older people, both in absolute figures and as a percentage of the population. In the US, people older than sixty-five now account for 16 percent of the population and consume one-third of all prescription medications. In fact, 20 percent of people over the age of sixty-five are taking at least five different medications. In the UK, the same age group accounts for 18 percent of the population and consumes close to 45 percent of all prescription drugs.
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There have been several prospective studies on this topic, although none with a global or multicountry scope. Yet the conclusion is damning: polypharmacy—taking more than five prescription pills a day—is associated with increased mortality risk; and it’s not just because people are old. In fact, the third most common cause of death today is prescription medication. Perhaps as a result of the overmedication of America, with drugs vying to occupy a share of the medicine cabinet over the past ten years, hospital admissions of the elderly due to medication side effects have tripled.
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Too many pills might kill you, but that’s only one part of the problem. Pills, no matter how many and how good, don’t cure chronic diseases—they just treat the symptoms (see Chapter 2). To be sure, single-pill fixed-dose combination therapy shows improved compliance with some diseases, like hypertension and HIV. But at what cost? An example is Zegerid, a combination of over-the-counter omeprazole (Prilosec) and bicarbonate of soda. Great for raising the pH of the stomach if you have an ulcer. But we now know that raising the pH of the stomach can lead to vitamin B12 malabsorption, altering the gut microbiome to increase the risk of gastrointestinal bacterial diseases like Clostridioides difficile. Is this such a good idea? And for these fixed-dose combinations, the drug company socks it to you on the price; a recent study argues that Medicaid spends an extra $1 billion per year on the combo version.
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And now there’s new data that even some of the inactive fillers or excipients in most pills (e.g., dyes like tartrazine [yellow], lactose, fructose) that make up 75 percent of the mass of the pill may in and of themselves be harmful in some patients, causing allergies, irritable bowel syndrome, and other inflammatory conditions.
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How about public health? Big Pharma made great contributions to public health efforts, until twenty to thirty years ago, with antibiotics (though their efficacy is dwindling) and vaccines. But since then there’s been very little progress. Between 2000 and 2008, a total of 667 drugs were approved by the FDA, yet only 11 percent of them were deemed truly innovative; the rest were knockoff analogs in an attempt to bully their way onto the market.
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Doctors know how to prescribe medicines—because that’s what they’re taught in medical school; and because doctors are the primary prescribers, they’re also the target of Big Pharma’s educational push. Currently, 70 percent of the US population is taking at least one prescribed medication. Is that because 70 percent of the population is sick? Well, actually yes. In fact, 88 percent of the population is thought to be metabolically ill. But does that mean that medicine is the treatment? If you ask Big Pharma, the answer is an unequivocal yes.
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Ever since government got out of medical research, it has left the playing field wide open. Starting with Ronald Reagan, there’s been a steady push from successive US administrations away from research, and by the time George W. Bush assumed office in 2001, the transformation was complete. Under George W. Bush, NIH Director Elias Zerhouni announced a new plan, known as the NIH Roadmap for Medical Research. Euphemistically, the NIH Roadmap initiatives “are designed to speed the movement of research discoveries from the bench into practice for the benefit of the public.” In reality, this plan shuttered clinical research centers nationwide; as Zerhouni said, patient research should be done by Big Pharma. I’ve witnessed this paradigm shift firsthand. Most clinical research has been cut back at the government and university level, leaving it open for Big Pharma to invest in whatever will turn the biggest profit.
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Except that Big Pharma’s reports of their own research are highly suspect. A meta-analysis by the Cochrane institute demonstrates that when the same drug is evaluated in two studies—one sponsored by Big Pharma and one independently—though the results are similar, the conclusions drawn are completely different. The industry reports were less transparent, had few reservations about methodological limitations, and had more favorable conclusions than the independent studies. Spin is everything. Can doctors trust what Big Pharma says about its own drugs? The answer is unfortunately no, we can’t; industry studies harbor a 37 percent bias toward their own drug.
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In the new millennium, Big Pharma has primarily contributed to increasing morbidity, in other words, keeping sick people with chronic diseases (cancer, diabetes, etc.) alive—so they can cost more money. And with no governmental regulation, medicines that have been around for a century have tripled in price in just one decade (e.g., insulin). For diabetics, insulin is indispensable; and it’s what the market will bear. For another egregious example, just look at what happened to the price of the EpiPen; kids with anaphylactic allergic reactions were forced to pay four times the original cost, because they had no choice—it’s literally a matter of life or death.
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But what if life feels like death? Staying alive in poor health is not a big winner. Between 2000 and 2008 the odds of surviving for at least five years after diagnosis increased 10.2 percent, and one additional drug approval increased the odds of surviving five years by 2.4 percent. Most of this life-span gain went to increasing time spent with morbidity. Adding extra time to morbidity is not a big winner either. In addition to cancer, a million people with diabetes are on dialysis; that’s an extra five years of life, but it’s all morbidity and costs $88,000 per patient per year.
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Big Pharma needs doctors to power the machine that generates their profit. Only one-third (85 billion profit comes from over-the-counter drugs that patients can buy without a prescription—and so Pharma has to keep doctors prescribing. The best way to do that? Control the medical school curriculum. And how to do that? Pay for stuff.
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Individual datapoints for American medical schools are harder to come by, but we know what’s going on with our Canadian friends north of the border. Canadian pharmaceutical company Apotex gave the University of Toronto CAN4,566,930 over two decades, Janssen donated CAN272,696 over two years, and Bristol Myers Squibb sponsored the salaries of two physician-scientists. We can only assume that American medical schools are reading from the same script.
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And it’s in the university’s best interest to maintain these industry relationships, for two reasons: 1) direct drug money as above; and also 2) potential drug money for in-house discoveries. Congressional passage of the Bayh-Dole Act of 1980 gave universities the right to patent any discoveries stemming from federally funded research, to own that IP, and then to license those discoveries to Big Pharma in return for institutional royalties.
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Before Bayh-Dole, universities were the wallflower. But after, universities joined Big Pharma on the dance floor for the Grand Waltz.
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Another way for Big Pharma to maintain the green gusher in the drug pipeline is to bypass the institutions altogether and co-opt the prescribers directly. In the past, to get their drug out into the world, drug companies would sponsor their own medical symposia—in places like Cancun or Hollywood or Maui—and would invite medical school faculty members to both talk and be talked to. Oh, and their wives’ expenses were paid as well.
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The mornings would be all science, and the afternoon would be all scuba diving. I myself had joined the faculty at the University of Wisconsin in July 1990, and by February 1991 I found myself in a lagoon spearfishing in Fort Lauderdale. All because I could prescribe human growth hormone. Of course, these symposia got expensive, and by the 2000s, the American Medical Association was beginning to scrutinize this practice—so it began to fall on the Big Pharma detail reps in the field to do the massaging. They would show up to clinic every week without fail, lunch in tow, ostensibly to provide clerical assistance in filling out the paperwork to start a new patient on growth hormone. I can’t tell you how many burritos I didn’t have to pay for. Sometimes we had reps from two different drug companies vying for our stomachs at the same time.
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In 2013, in an attempt to limit their influence, academic medical centers banned pharma reps from their campuses, and subsequent prescriptions for brand-name medications fell while generics increased. Yet only 36 percent of private hospitals have followed their lead—Big Pharma reps continue to lobby doctors in hospitals nationwide. And the Empire is striking back. A 2017 U.S. Supreme Court case, Sorrell v. IMS Health Inc., argues that Big Pharma can data mine information from patients, leaving open the possibility that drug companies can access patient records.
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Recently, a group of AstraZeneca-affiliated clinicians argued that by reducing access to reps, doctors weren’t up-to-date on medical breakthroughs. So now medical schools are blaming the doctors instead of the pharma companies, by tightening regulations on professors who exhibit conflicts of interest. Point being, Modern Medicine and Big Pharma remain caught in a vicious cycle: doctors need Big Pharma because they’re taught to treat rather than cure or prevent; but the reason they don’t know any better is because medical education has been co-opted by Big Pharma itself. And so the cycle repeats.
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All medicines are selective toxins, poisoning one specific pathway in the body. Pharma grew in the 1950s because of the success of antibiotics that poison the cellular pathways of bacteria (which are like plant cells) without poisoning other necessary animal cell pathways. This is why they’ve been effective in eradicating most acute infectious diseases.
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But when we’re dealing with chronic conditions, the dysfunctional pathway is the human’s energy metabolic pathways (not the bacteria’s), primarily our mitochondria (see Chapter 9). But there’s no medicine that can get to and fix the mitochondria. In fact, treating with antibiotics for acute infectious diseases may have altered the bacteria in our gut so severely that new and resistant bacteria have moved in to take their place. The bacteria battling in our intestines can cause leaky gut and systemic inflammation, furthering chronic disease. Further, our gut microbiomes have been altered by the antibiotics added to our food supply (see Chapter 18), which also drives systemic inflammation, making us even sicker.
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All of our medicines are treating the symptoms that come from these various mitochondrial perturbations: for instance, blood pressure medicines fix the blood pressure, but not the mitochondria. Yet by treating solely these symptoms, the pharma industry has lulled people into a false sense of security that their disease has been ameliorated. Wrong. The symptoms of their disease have been ameliorated. Until the actual cause of the condition is addressed, there’s no quick fix. And there’s no pill for this.
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So, what’s the solution? Some in the profession think they’re just doing their job, while others know that they’re taking money under false pretenses. How do we hold the medical profession accountable for spinning its wheels addressing the symptoms of the problem rather than the problem itself, and making money off the victims? Big Pharma is the first of the three immoral hazards delineated in this book, creating the problem, and making money off the misfortunes of others. More to come, stay tuned.