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Double Standards, Trojan Style

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…

The Ethics of Keeping Alfie Alive

By SAURABH JHA

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.”

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Will Cancer Drugs Ever Be As Affordable As Retrovirals in Low and Middle Income Countries?

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…

The Case For Real World Evidence (RWE)

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.

The power and value of RCTs can be seen with particular clarity in the case of proposed interventions that made so much intuitive sense (at the time) that it seemed questionable, perhaps even immoral, to conduct a study. Examples include use of a particular antiarrhythmic after heart attacks (seemed sensible, but actually caused harm); and use of bone marrow transplants for metastatic breast cancer (study viewed by many as unethical yet revealed no benefit to a procedure associated with significant morbidity).

In these and many other examples, a well-conducted RCT changed clinical practice by delivering a more robust assessment of an emerging technology than instinct and intuition could provide.

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Alfie Evans and the Medical Ethics of Suffering

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.

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Trump and Rx Drug Prices: Let the Games Begin

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…

A Public-Private Partnership to Fix Health Care

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…

Empowering Patients through Decentralized Information Governance

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.

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MedStar Franklin Center:  The Case Against Global Capitation

Baltimore County, Maryland is one hour north of Washington DC, where politicians appear impotent to contain runaway healthcare expenditures.  In January 2014, the Centers for Medicare and Medicaid Services (CMS) in partnership with the state of Maryland, piloted an “All Payer Model,” where every insurer, including Medicare and Medicaid, paid a fixed annual amount irrespective of inpatient or outpatient hospital utilization.  Maryland agreed to transition hospitals from fee-for-service arrangements to this global capitation model over five years. 

Capitation, in general, reimburses a fixed amount per patient, unrelated to service volume.  This sets an artificial fiscal ceiling and disincentivizes hospitals, physicians, and other healthcare personnel to provide healthcare. The philosophy is if hospitals or physicians reduce their output and save money, the unused funds can be kept by the organization. The basic premise of capitation pays hospitals, physicians, and others to AVOID providing care, an unfortunate consequence. 

Maryland is experimenting with global capitation, which allots a fixed sum to an institution from each payer, making revenue predictable, while at the same time, encouraging stewardship by the hospital to allocate funds wisely.  When expenses are lower than the prearranged sum, that hospital retains the leftover funds as additional profit.  To ensure care is not withheld to increase revenue, quality measures are assessed and shared publicly.  A 2015 report in the New England Journal of Medicine showed expenditure reductions of 0.64% and inpatient admissions decreased by 5%.   However, with unproven payment arrangements, unintended consequences always occur. 

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Trump’s Docs

It’s now clear that two public assessments of President Trump’s health since 2015—the only ones we know about—were seriously compromised.   

The import of this has been eclipsed by other (more salacious) recent events—Stormy Daniels, etc.   But what has transpired raises troubling questions and should prompt a reassessment of how candidates for president and presidents are medically evaluated, and the public’s right to that information.     

I’ve written two pieces for THCB on Trump’s physical and mental health.  You can find them here and here. 

The first assessment of Trump’s health, conducted in 2015 by his personal physician of 35 years, Harold Bornstein, is now under a dark cloud.   Bornstein told CNN this month that Trump dictated the contents and language of a one-page letter signed by Bornstein and released publicly by the Trump campaign in the early months of the campaign.    

The letter aimed to assuage concerns about Trump’s age and health status.  Clinton and Trump were two of the oldest candidates ever to make a presidential bid and neither had shared much information about their health status up to that point; both were under pressure to do so.

“He dictated that whole letter. I didn’t write that letter,” Bornstein told CNN.  He had previously admitted (in August 2017) that he had typed the letter in his office in just five minutes while a limo sent by Trump waited outside.   

At the time, the four-paragraph letter seemed suspicious, to say the least.   It didn’t contain any details of test results or the like.   Instead, the letter made unusual and hyperbolic statements about the president’s health such as: “His [Trump’s] physical strength and stamina are extraordinary.”  And:  “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.”Continue reading…

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