Seven years ago, I faced a serious cardiac arrhythmia, ventricular tachycardia. Over time, it worsened, leading to multiple ambulance rides and hospitalizations. My experience, while harrowing, highlighted both the remarkable advancements and the deep flaws within modern medicine.
On the positive side, I benefited from the expertise of two exceptional doctors. In a complex six-hour procedure, they meticulously mapped and ablated the errant electrical signals in my heart. Since then, I’ve been symptom-free – a testament to the incredible capabilities of contemporary medical science.
However, the shortcomings of the system became starkly apparent just days after my procedure. During intensive care unit rounds, a cardiologist, advocating for more aggressive use of cholesterol-lowering statins, began citing studies to support his recommendation for me to increase my statin dosage. I inquired whether he had critically examined the underlying research. He had. I then questioned the appropriateness of the endpoints in many of these studies for truly assessing statin benefits, to which he conceded ongoing debate. Finally, I asked if he was aware that peer reviewers in even the most prestigious medical journals often lack access to the raw data from the clinical trials they evaluate. He reluctantly admitted he was.
Essentially, his advice to escalate my statin medication was rooted entirely in commercially-sponsored and heavily influenced medical journal articles, vetted only superficially. This incident underscores a fundamental issue: the commercial capture of medical knowledge that physicians rely on and implement daily.
But before delving deeper into the commercialization problem, let’s consider the broader context of why it’s reasonable to conclude that U.S. health care is fundamentally off course.
A straightforward indicator of a nation’s health, and a metric for international comparison, is average life expectancy. Examining a chart comparing the U.S. average life expectancy to that of eleven other affluent nations from 1980 to 2021 reveals a concerning trend. In 1980, the U.S. was roughly on par with these countries. However, over the ensuing decades, U.S. life expectancy has progressively lagged behind. While it continued to rise until 2014, the gains were significantly less than those in comparable nations.
By 2019, even before the COVID-19 pandemic, the disparity in life expectancy had widened to such an extent that an estimated 500,000 Americans were dying annually, exceeding the death rates of citizens in these peer countries. To eliminate socioeconomic factors, a study focused on privileged Americans – specifically, white individuals residing in counties within the top 1% and 5% income brackets. Even this affluent demographic, while exhibiting better health outcomes than other U.S. citizens, still experienced worse health outcomes than average citizens in other developed nations across critical areas like infant and maternal mortality, colon cancer, childhood acute lymphocytic leukemia, and acute myocardial infarction.
Compounding these alarming health statistics is the exorbitant cost of U.S. health care. The U.S. spends an average of $12,914 per person annually on health care, while the average in comparable countries is $6,125. This translates to an excess of $6,800 per person. Across a population of 334 million Americans, this amounts to a staggering $2.3 trillion in excess annual health care expenditure – for demonstrably poorer health results.
This stark contrast unequivocally demonstrates that the American health care system is broken and urgently requires fixing.
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Echoing President Eisenhower’s 1961 warning about the “military-industrial complex,” we now face a pervasive medical-industrial complex. This complex is draining America’s wealth, diverting resources from other crucial areas that could enhance public health and improve American lives.
What should be the paramount objective of American health care? To my mind, it is to maintain and improve both individual and population health with maximum effectiveness and efficiency. If this is the agreed goal, then two critical questions demand our attention: (1) Why are we failing so dramatically to achieve this objective? and (2) Why are doctors and other health professionals complicit in this dysfunctional system?
A primary driver of the widening health gap between Americans and citizens of other wealthy developed countries is the medical-industrial complex’s control over what is accepted as valid medical knowledge by both doctors and the public. This influence has evolved gradually over time.
Back in 1981, as I completed my medical residency and began a research fellowship, rigorous scrutiny of medical journal articles was standard practice, and commercial bias was not a significant concern. However, 1981 marked a turning point. Derek Bok, then president of Harvard University, in Harvard Magazine, expressed concern that the university’s growing reliance on industry funding for research was creating “an uneasy sense that programs to exploit technological development are likely to confuse the university’s central commitment to the pursuit of knowledge.” He noted that declining grants from the National Institutes of Health and the National Science Foundation were pushing researchers toward commercial funding sources.
Similarly, a 1982 Science journal article, “The Academic-Industrial Complex,” highlighted the shift of universities from pursuing knowledge for its societal and scientific merit to pursuing knowledge for commercial gain. Today, it’s commonplace for medical school professors to have commercial ties. But this was not always the norm, and it doesn’t have to remain so.
A second pivotal event was the 1980 passage of the University and Small Business Patent Procedures Act, or Bayh-Dole Act. Amid concerns about Japanese economic competition in the late 1970s, the Act aimed to spur commercialization of university research. It allowed universities and non-profit research institutions to profit from discoveries made during federally-funded research, including patenting pharmaceuticals. This legislation effectively transformed universities into market players, embedding them within the burgeoning medical-industrial complex.
The immediate consequence was a shift in research sponsorship and control. In 1991, universities conducted 80% of pharmaceutical research, with independent academics overseeing analysis and publication. By 2004, however, only 26% of pharmaceutical industry research occurred at universities. The remaining 74% was outsourced to for-profit research companies. While these companies might engage medical centers for assistance, the overarching control of research had migrated from academic institutions to the pharmaceutical industry – a radical transformation.
A 2005 New England Journal of Medicine article revealed that 80% of clinical trial agreements granted drug companies ownership of the research data. Clinical trial data, excluding proprietary manufacturing techniques, should be considered a public good, crucial for informing doctors’ treatment decisions. However, pharmaceutical companies prioritize marketing objectives.
Internal Pfizer documents, revealed during litigation, explicitly state that “Pfizer-sponsored studies belong to Pfizer, not to any individual,” and that the “Purpose of data is to support, directly or indirectly, marketing of our product.” The focus is not primarily on enhancing patient health or well-being, but on bolstering marketing efforts.
These internal documents further detail how data is leveraged for marketing, including “publications for field force use.” This translates to drug companies purchasing reprints of medical journal articles for their sales representatives to distribute to doctors, incentivizing prescriptions. This practice would be acceptable if these journal articles underwent truly independent peer review, ensuring research accuracy and completeness. However, under the current system, trust is misplaced.
The New England Journal of Medicine survey also found that 24% of clinical trial agreements allowed sponsors to “include its own statistical analysis in manuscripts.” Even more concerning, 50% permitted sponsors to “write up the results for publication and the investigators may review the manuscript and suggest revisions.” In half of these agreements, drug companies ghostwrite articles, with researchers, as named authors, limited to suggesting revisions, not making substantive corrections or edits. This is a far cry from academic freedom and undermines medical science’s service to the public interest.
I once questioned an editor of a leading medical journal about why journals don’t mandate drug companies to submit comprehensive internal clinical study reports and data, redacting only proprietary information. The editor responded candidly: “That would be a death spiral for the journal.” He acknowledged the problem but explained that publishing major clinical trials is essential for journal prestige and reprint sales to drug companies. (Notably, in 2005, The Lancet derived 41% of its revenue from reprint sales.)
While medically irresponsible, medical journals’ lack of transparency regarding drug data is financially rational given their dependence on pharmaceutical industry revenue.
In summary, the biomedical market deviates significantly from Adam Smith’s 18th-century ideal of a free market. It’s not akin to purchasing bread, meat, or beer, where consumers can directly assess quality and price fairly. Biomedical products are “credence goods”— their value cannot be easily evaluated by the buyer. Consumers must rely on expert evaluation. And with prescription drugs, manufacturers wield a near-monopoly on crucial information.
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Regarding excessive costs, three primary factors are at play. First, the U.S. is unique among wealthy nations in lacking a formal mechanism for drug price negotiation. Second, widespread insurance coverage insulates consumers from the true cost, weakening market price discipline. Third, as a nation, we may be excessively captivated by the allure of biomedical innovation.
Historian Jill Lepore astutely noted, “Innovation might make the world a better place, or it might not.” Innovation, she argues, is not necessarily about “goodness” but often driven by “novelty, speed, and profit.” In the biomedical field, many innovations are marketed without proper evaluation of their genuine public value.
In the U.S., a staggering 96% of biomedical research funding is directed towards medical drugs and devices, while a mere 4% is allocated to improving population health and optimizing health care delivery. Specifically, $116 billion is spent on researching new drugs and devices (representing only 13% of total health care costs), compared to just $5 billion on research addressing the remaining 87% of costs. This imbalance arises because drug companies prioritize maximizing investor returns, and the highest returns are not in promoting healthy lifestyles but in selling drugs and devices. This skewed research focus creates a significant epidemiological bias in the information available to doctors.
Even when new drugs are approved, only about one in four offers a significant advantage over existing, less expensive treatments. Germany’s Institute for Quality and Efficiency in Health Care, an independent agency under the Ministry of Health, assessed 216 new drugs introduced in Germany from 2011 to 2017. Only 54 were deemed to have “major” or “considerable” benefit. 37 were rated as having “minor,” “less,” or “non-quantifiable” benefit. For 125 drugs, there was “no proof of added benefit.” In the U.S., lacking a robust evaluation system, doctors struggle to discern which new drugs offer genuine value. They are bombarded with marketing and industry-sponsored articles promoting all drugs, hindering their ability to act as informed intermediaries.
In my recent book, I discuss Trulicity, a diabetes drug heavily advertised and marketed for its heart disease risk reduction. However, the “number needed to treat” (NNT) for Trulicity – a crucial metric indicating how many patients need treatment for one to benefit – was conspicuously absent from marketing materials. For Trulicity, the NNT is 327 people treated for approximately three years to prevent one non-fatal heart event. Treating these 327 individuals over three years would cost $2.7 million. This information is critical for both doctors prescribing and patients considering the drug, especially when factoring in potential side effects, often underreported or unmonitored in clinical trials and journal articles.
Thus, numerous brand-name drugs, irrespective of their effectiveness, are aggressively marketed. Drug companies holding patents operate as monopolies. Brand-name drug prices in the U.S. are 3.5 times higher than in other wealthy developed countries. More alarmingly, the rate of price increase is staggering. In 2008, the average annual price for a new drug in the U.S. was $2,115. By 2021, it had skyrocketed to $180,000. In 2022, the average annual price reached $257,000.
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Big Pharma companies are, by nature, for-profit entities. Their primary responsibility is maximizing returns for investors. Accusing them of greed is misdirected; they are simply fulfilling their inherent purpose. The onus is on us – doctors, policymakers, and the American public – to establish safeguards ensuring the pharmaceutical industry serves, rather than undermines, public health.
The necessary prescriptions are clear. First, we must ensure the accuracy and completeness of the medical evidence base through independent, transparent peer review. Second, we need to implement robust health technology assessment to guide doctors and patients toward the most effective treatments. Third, we must control brand-name drug prices.
These are not insurmountable challenges. The primary obstacle is the bipartisan consensus among political leaders to accept substantial campaign contributions from drug companies. Vast sums of money flow to both Democrats and Republicans. Meaningful reform requires a broad coalition of Americans demanding action. I urge those on the conservative side, wary of government intervention, and those on the progressive side, critical of unfettered markets, to find common ground and a middle way to address declining health and escalating costs.
We must transcend ideological divides and prioritize the well-being of our nation and its people. Neither side acting alone can dismantle the medical-industrial complex’s stranglehold on American health care. Instead of focusing on our differences, we must unite on our shared goals: healthier Americans and a health care system that doesn’t cost twice as much for poorer outcomes compared to other wealthy nations.
Oliver Wendell Holmes astutely observed in 1869, “The state of medicine is an index of the civilization of an age and country—one of the best, perhaps, by which it can be judged.” Medical science is an invaluable gift, but we must wield it wisely, ensuring it serves the American people with the best and most efficient care. We cannot allow it to remain captive to the medical-industrial complex.
