Frances Oldham Kelsey by all accounts was not mean to have a consequential life. She was born in Canada in 1914, at a time women were meant to be seen and not heard. Nonetheless, an affinity for science eventually lead to a masters in pharmacology from the prestigious McGill University. Her first real break came after she was accepted for PhD level work in the pharmacology lab of a professor at the University of Chicago. An esteemed professor was starting a pharmacology lab and needed assistants, and the man from Canada seemed to have a perfect resume to fit. That’s right, I said man. Frances was thought to be a man’s name, and the acceptance letter accepted Mr. Frances Oldham. Given the times, her Canadian mentor advised the young Frances she not write to inform the Chicago professor of the mistake but to simply sign the acceptance letter as Miss Oldham. The rest, as they say, is history. Ms. Frances Oldham arrived in Chicago in 1936, and just two years later was asked to work on figuring out what caused one of the worst poisonings in American history by the nascent US Food and Drug Administration (FDA).
The FDA at the time was a small organization within the federal government that had come into being a few decades earlier after the passage of one of many progressive laws passed to protect consumers from rapacious pharmaceutical companies of the day. At the time there was no standard for claims that could be made to an unsuspecting public and no requirement that drug companies specify what ingredients were being consumed by the public. The companies of the day would take alcohol, water and coloring mixed together – give the formulation a name, get a US patent, and make millions by heavily marketing testimonials of cures to all that ails directly to the consumer. At one point, it was estimated that there was more alcohol being sold via ‘patent medicines’ than at liquor stores.
Sadly, it was not medical professionals that put a stop to this, but muckraking journalists like Samuel Hopkins Adams who exposed the seamy underside in a series of articles for Collier’s Weekly entitled The Great American Fraud. Popular outrage followed publication of this series in 1905 and in response, the first draft of the FDA came into being by order of Congress in 1906.
The initial purpose of the FDA was a small, but important one – ensure the correct labeling of drugs being sold to the public. The 1906 act – fought tooth and nail by industry – mandated that ingredients such as alcohol, cocaine, heroin, morphine and cannabis be accurately labeled with contents and dosage. To understand the scope of the problem at the turn of the century, understand that Coca-Cola (Coke) was sold initially as a ‘patent medicine’ that was marketed as a cure for headaches, impotence, morphine addiction as well as a number of other ills. The main ingredients? Cocaine and Caffeine. Current drinkers of Coke will be happy to know that cocaine was eliminated from the formula in 1903.
The FDA as we know it now is a result of the passage of the Federal, Food, Drug and Cosmetic Act (FFDCA) of 1938 that came as a reaction to national tragedy in 1937 that once again drove home the point that the public needed protection from private corporations. The matter was a simple one that involved an ingredient that actually worked – sulfanilamide. Sulfanilamide was an antibiotic that killed bacteria by preventing the synthesis of Folic Acid. Humans are relatively primitive and don’t make Folic acid – so it isn’t toxic to humans. That is, unless you’re the chief chemist of S. E. Massengill Company, and you create a preparation of sulfinilamide that is dissolved in di-ethylene glycol (DEG). DEG is toxic to humans – the first case reports of toxicity had been reported six years earlier. Unfortunately the chemist, Harold Watkins, who worked for the company was unaware as this was not widely known at the time. Watkins simply added some raspberry flavor to the sulfa dissolved in DEG, and the company founded by a Tennessee medical student who saw more opportunity in selling drugs to doctors than practicing medicine started distributing the drug widely. No animal studies or any type of premarket testing was required at the time, and so the drug went straight from the lab to the consumer. More than a hundred people died.
In the depths of winter, America was shocked by the video of a young, bruised and confused woman being discharged from a Maryland Hospital – alone into the cold night, wearing nothing but a thin hospital gown and socks. Hospital security officers dropped her at the nearby bus-stand and then briskly wheeled away the chair in which they had brought her out, deftly avoiding the questions of a concerned citizen who bore witness to this inhumane act. Most healthcare workers in the U.S., physicians and nurses, allied health professionals, and janitors alike felt a wretched sadness watching the video, recognizing as they did another sign of the sickness that ails the healthcare system today.
As our culture has become increasingly more consumeristic, healthcare has become increasingly more commercialized. A “provider interaction” has become a commodity; and hospitals have become the factories producing that commodity. This has shifted the balance of power from healthcare providers to professional managers. This change, ostensibly done to provide doctors more time to practice their art, instead has insidiously but surely changed the culture of our healthcare institutions.
The daily-lived values of our institutions have changed from the core values of medicine – caring, compassion and empathy for the patient, to more corporate values of productivity metrics and profits. What was to be a properly balanced socio-economic model for hospitals has gone tragically wrong. The goal was efficacy – efficient and effective patient-centric care. However, the disproportionate focus on efficiency, achieved by applying industrial engineering and productivity standards to patient care, has compromised effectiveness. More importantly, this has eroded the core of patient-centric care – compassion and empathy. That the CEO of the Maryland hospital insisted that the patient was provided appropriate medical care, even as he acknowledged the failure of humanity and compassion, sadly demonstrates that compassion and empathy are no longer the core values of healthcare.
The University of Southern California (USC) appears to look the other way when male physicians harass or assault women. In reality, sexual violence spares no occupation, including medicine, but the way an organization responds to crime against women indicates a certain level of integrity. The World Health Organization estimates sexual violence affects one-third of all women worldwide. In a nation where women make up 50% or more of each incoming medical school class, only sixteen percent of medical school deans are female, making gender imbalance in leadership positions nearly impossible to overcome.
For the second time in less than a year, USC President C.L. Max Nikias is grappling with sexual misconduct allegations against a physician faculty member. Complaints go back to the early 1990s from staff and patients about inappropriate comments and aggressive pelvic exams done by Dr. George Tyndall, the only full-time gynecologist for the past three decades at the campus clinic. USC ignored complaints until a nurse contacted the campus rape crisis center.
Dr. Tyndall was initially suspended pending inquiry and forced to resign shortly thereafter. More than 100 complaints have been received and five are suing USC.Continue reading…
Of my time arguing with doctors, 30 % is spent convincing British doctors that their American counterparts aren’t idiots, 30 % convincing American doctors that British doctors aren’t idiots, and 40 % convincing both that I’m not an idiot.
A British doctor once earnestly asked whether American physicians carry credit card reading machines inside their white coats. Myths about the NHS can be equally comical. British doctors don’t prostate every morning in deference to the NHS, like the citizens of Oceania sang to Big Brother in Orwell’s dystopia. Nor, in their daily rounds, do they calculate opportunity costs for keeping patients alive on ventilators.
Conversations such as this are vanishingly rare.
Administrator: “It’s costing an arm and leg keeping this sick baby alive – to balance the annual budget we need to stop dialyzing a granny.”
ICU doctor: “We’ll have to send poor Ethel to her grave. That’s a shame. She was beginning to grow on me.”
Health Ethicist: “Wait, let me check with National Institute of Clinical Excellence, the rationing experts, who should be relieved of intensive care first. Perhaps it should be Winston, not Ethel – because Winston is an alcoholic. We need to make rationing scientific and fair.”
In 2014, the majority of international health aid was dedicated to HIV. So, one might reasonably assume that this is the largest health problem facing the world. Yet, HIV only constitutes 4% of the global burden of disease. In 2014, noncommunicable diseases (NCDs) made up 50% of the entire disease burden, but only received 2% of all global health funds.
The disease burden of NCDs is fast outpacing that of infectious diseases. Despite this, the proportion of global health financing dedicated to combatting NCDs has remained constant over the past 15 years at 1 to 2%.
Currently, 32.6 million individuals are living with cancer (diagnosed in the last five years). In 1970, 15% of new cases were in low- and middle-income countries. In 2008, 56% were in low- and middle-income countries. By 2030, this proportion is expected to be 70%. So, not only is the burden of NCDs rising globally, but it is also beginning to disproportionately affect countries with the least resources to deal with them.
But, if NCDs have been steadily increasing in low- and middle-income countries, why has global action not followed suit? Continue reading…
Randomized control trials – RCTs – rose to prominence in the twentieth century as physicians and regulators sought to evaluate rigorously the performance of new medical therapies; by century’s end, RCTs had become, as medical historian Laura Bothwell has noted, “the gold standard of medical knowledge,” occupying the top position of the “methodologic heirarch[y].”
The value of RCTs lies in the random, generally blinded, allocation of patients to treatment or control group, an approach that when properly executed minimizes confounders (based on the presumption that any significant confounder would be randomly allocated as well), and enables researchers to discern the efficacy of the intervention (does it work better – or worse – than controls) and begin to evaluate the safety and side-effects.
Sadly, the case of Alfie Evans came to a close this week, as he passed away in his hospital room surrounded by his parents. The debate over the medical ethics involved goes on.
Ultimately, there are extensive moral, philosophical, and medical issues involved with the policies over these cases. They are complicated, messy, and often times heart wrenching. But let’s put some misconceptions aside to begin with, some propagated by the most extreme and emotional participants in this debate.
Those of us that took issue with the handling of this case for the most part do not believe the doctors involved were evil, murdering individuals. There was no malicious intent from the NHS or physicians involved. I am sure the physicians meant well, from their point of view.
A second point: this was not a case about preservation of resources for the greater good. In this case, the parents had found alternative sources to fund the care they wished for their son. So those arguing that we need to make such decision to prioritize money for those that can be aided the most is largely off target, and not relevant to the case at hand. I also don’t believe that the single payer system of the NHS in England inherently caused their mistakes; I think any system that is blind to its own deficiencies could lead to such mistakes.
That said, what were the issues that were in dispute here?
First and foremost, what was the ultimate intent of the care providers in this specific case? Both sides basically admitted, early on, that Alfie’s prognosis was dire. The reality is this child was likely going to die, and even the experts preferred by the parents readily admitted this in court documents.
President Trump is scheduled to deliver a major speech on drug prices today.This post is intended to start a dialogue on what he says and proposes.
It’s unclear whether Trump will provide specifics or whether those will be rolled out in coming weeks. As is always the case with Trump, there’s concern he’ll go off script despite apparent careful preparation of the speech.
The speech is reportedly going to coincide with an RFI from HHS on ways to restrain drug prices, building on ideas proposed in the administration’s fiscal 2019 budget request. That sounds like a delay tactic, but we’ll see.
Notably, Alex Azar and Scott Gottlieb, health secretary and FDA Commissioner, respectively, have recently hinted at substantial policy proposals.Azar, for example, has proposed shifting some of the drugs now paid for under Medicare Part B (such as chemotherapy drugs administered in doctors’ offices) to Part D, where private plans would have clout to push for lower prices.
Azar and CMS administrator Seema Verma have also suggested requiring PBMs to share the savings from drug rebates with consumers. Continue reading…
The Administration proposal that would enable small employers to band together to purchase health insurance by forming Association Health Plans has several good features. Large companies do pay about 15% less, apples-to-apples, for health insurance than small businesses because they negotiate lower administrative fees, get larger discounts on health care prices and avoid premium taxes and risk charges by self-insuring. Allowing small business to replicate what boils down to volume discounts also appeals politically to many as a market-based alternative to government intervention. Reliance on Association Health Plans could result in substantial volume discounts, but, in the end, would be like paying $10 for a tube of toothpaste that retails for $100, a big discount and a rip-off price.
Even though the largest companies get very deep discounts, there is substantial research showing that their net costs are much higher than everywhere else because we in the United States pay higher prices for health care goods and services. One need to look no further than the benchmark large corporate purchasers who continue to pay about 40% or 50% more than Medicare for the same health care to see how excessive health care prices for private payers are. And this disparity is likely to get worse. While hospitals gobble up other hospitals and doctors’ practices and gain near monopoly market power to raise prices, employers of all sizes remain highly fragmented and, as a result, impotent price negotiators.
A better approach to health care cost containment than Association Health Plans hides in full view. Continue reading…
Seema Verma is right, US health care will be transformed if we empower patients and physicians through access to information. Don Rucker is right to focus attention on APIs to enable the transformation. A year and a half into the new administration and the massively bipartisan 21st Century Cures Act, the Department of Health and Human Services (HHS) is having to navigate between the shoals of highly unpopular Meaningful Use regulations and the apparent need for regulation to undo the damage of market consolidation that they caused. From my perspective, it looks like HHS is doing a good job.
Prediction is a dangerous game but it’s necessary for investments that depend on health information technology. Nowadays, pretty much everything in healthcare depends on information technology, particularly if we need effective quality measures to enable transition to value-based healthcare.
Based on Verma’s most recent remarks, it’s safe to predict that HHS will use the power of the $900 Billion purse as a way of avoiding regulation as it tries to break down the oligopoly of the consolidated “integrated delivery networks” and their even more consolidated EHR vendors. What’s more interesting is to anticipate how Rucker’s recent remarks about Persistent Access will be translated into decision support information for patients and physicians that will actually drive the practice innovation Verma is talking about.