For American Indians, Health is a Human and Legal Right

Sam Aptekar
Phuoc Le

By PHUOC LE, MD and SAM APTEKAR

Most will be surprised to learn that American Indians and Alaska Natives represent the only populations in the United States with a legal birthright to health care.[1] Even though Article 25 of the UN’s Universal Declaration of Human Rights declares, “everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including…medical care and necessary social services,” U.S. federal policy only guarantees this human right to enrolled tribal members. The source of this juridical entitlement is what the United States Supreme Court has defined as the federal trust responsibility.

Between 1787 and 1871, the United States signed nearly 400 treaties with Indian tribes, in which, for the exchange of millions of acres of tribal land, the U.S. government promised in perpetuity to respect their sovereignty and provide benefits, including housing, education, and healthcare. Argued in March 1983, United States v. Mitchell is the most recent Supreme Court case establishing this principle as a matter of law. This week marks the 36-year-anniversary of that seminal case, providing us the opportunity to discuss the federal government’s failure to adequately fund the healthcare institutions that serve American Indians and Alaska Natives despite its legal responsibility to do so.

Supreme Court Justice Thurgood Marshall penned the majority opinion of United States v. Mitchell.

The current life expectancy for American Indians and Alaska Natives is 73 years, 5.5 years less than that of the general population. American Indians die at higher rates from heart disease, cancer, diabetes, stroke, and kidney disease. When we consider why Native communities suffer from preventable and treatable diseases at disproportionate frequencies, we must first evaluate the inequity in Congressional funding for Indian Health Services (IHS), the national agency within the Department of Health and Human Services that is responsible for providing comprehensive healthcare to the country’s enrolled American Indians and Alaska Natives.

Data Source: Indian Health Service

Based on the most recent available data, per capita spending on Indian Health Services is far lower than any other federal health care agency, including Medicare, Medicaid, and the Bureau of Prisons. In 2016, Congress invested$3,337 per capita on Indian health care, compared to $5,000 on prisoners and $12,744 on Medicare beneficiaries. For anyone intent on remedying the perpetuation of chronic health disparities that afflict Native communities, Congress’ stark underfunding of IHS should be prioritized rectification.

Date Source: The National Tribal Budget Formulation Workgroup’s Recommendations of the Indian Health Service Fiscal Year 2019 Budget

According to a report published by the U.S. Commission on Civil Rights, an independent, bipartisan agency established by Congress, “Over the past 300 years, Native Americans have traded hundreds of millions of acres to the federal government in exchange for benefits to guarantee the survival and integrity of their tribes, including health care.” So why does the only population in the United States with a guarantee to healthcare at birth suffer from preventable diseases at grossly disproportionate rates? There is no easy answer to this question as it is both morally and legally reprehensible.

If we, as physicians, wish to see the actualization of the historical promises made by the U.S. government to its American Indian citizens, we must be aware of, and speak up for, the urgent need for increased funding to IHS. To be sure, this is not where the fight ends; more equitable health outcomes will only occur if we also target systemic inequality in housing, education, and income, but it is certainly a starting point we can all rally behind.

[1] There is no universally agreed-upon term for the first peoples of North America. In his influential 1998 essay, “I Am an American Indian, Not a Native American!” South Dakota activist Russel Means denounced “Native American” as a “generic government term used to describe all the indigenous prisoners of the United States.” Other activists, however, have provided differing perspectives. Ultimately, the decision lies with individuals among these communities. However, the authors of this post have selected the imperfect term “American Indian” because of its legal implications; at a 1977 United Nations conference in Geneva, the Native representatives unanimously elected the use of “American Indian,” which now predominates in legal settings.

Internist, Pediatrician, and Associate Professor at UCSF, Dr. Le is also the co-founder of two health equity organizations, the HEAL Initiative and Arc Health.

Sam Aptekar is a recent graduate of UC Berkeley and a current content marketing and blogging affiliate for Arc Health Justice.

This post originally appeared on Arc Health here.

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Health in 2 Point 00, Episode 75 | Rounds & IPOs, Health Datapalooza, & the Facebook Controversy

Today on Health in 2 Point 00, Jess and I are at 10th annual Health Datapalooza in Washington D.C.! Jess talks to me about Xealth’s $11 million round to develop out its company, and Change Healthcare is applying for a $100 million IPO. The big takeaways from Health Datapalooza are that many people and companies have integrated data into their systems, but they haven’t been able to gain many actionable insights from it. Also, if you haven’t heard of the complaint Andrea Downing, Fred Trotter, and David Harlow wrote to the FTC concerning the privacy and data that can be downloaded from Facebook’s groups, you better check it out. It details out the concern that Facebook is not protecting the data of patients as anyone can download sensitive data from the groups and use it — Matthew Holt

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All for One, One For All

By MIKE MAGEE MD

Within the ever-widening array of Democratic contenders for the Presidency, the “Medicare-for-all” debate continues to simmer. It was only six weeks ago that Kamala Harris’s vocal support drew fire from not one, but two billionaire political rivals. Michael Bloomberg, looking for support in New Hampshire declared, “I think we could never afford that. We are talking about trillions of dollars… [that] would bankrupt us for a long time.” Fellow billionaire candidate Howard Schultz added, “That’s not correct. That’s not American.”

Remarkably, neither man made the connection between large-scale health reform’s potential savings (pegged to save 15% of our $4 trillion annual spend according to health economists) and the thoughtful application of these newly captured resources to all U.S. citizens without discrimination. Bloomberg’s own 2017 Health System Efficiency Ratings listed the U.S. 50th out of 55, trailed only by Jordan, Columbia, Azerbaijan, Brazil, Russia. Yet he seemed unable to connect addressing waste with future affordability.

Schultz was similarly short sighted. While acknowledging that the
manmade opioid epidemic, mental health crises, and income inequality are
“systemic problems” and at levels “the likes of which we have not had in a long
time”, he failed to connect the cause (a remarkable dysfunctional and
inequitable health care system) with these effects.

As I outline in “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/ June 4, 2019), today’s greatest risk to continued progress and movement toward universal coverage and rational health planning is sloppy nomenclature.  To avoid talking past each other, we need to define the terms of this debate while agreeing on common end points.

“Universal health care” is an end point goal
that reinforces the principle that health is a human right rather than a
privilege for the most entitled. It is an expression of national solidarity and
reflects a shift in our culture.

“Single payer” is one strategy or tactic often
associated with the Canadian health care system. However, the Canadian system
is not technically a “single payer” system, in that provision of insurance (set
to national standards) and the delivery of the care are the responsibilities of
individual provinces, not the national government. A more accurate label for
their system would be “Single Oversight/Multi Plan”.

Canada has choice and also maintains an active private health insurance market that provides supplemental health care plans purchased by 70% of citizens to cover roughly 30% of health costs including optical, dental and drugs which are not covered by government plans. Private insurers in the U.S. in the future might play a similar role.

The Canadian government’s role is focused on formalized government health planning as well as insurance standards and oversight. It also outlaws DTC drug advertising and sets prices annually for all essential drugs. The national government is the guardian of universality and (often overlooked) simplicity. Providers provide. Provincial government pays. Patients concentrate on health and wellness, and are not plagued by insurance gamesmanship and endless bill bickering on the local level.

The U.S. has no such government-directed, national health planning apparatus. Service levels and reimbursement vary widely across an endless array of private and public offerings that have devolved into a “free-for-all.” Our profit-driven, scientific research community regularly diverts resources from health planning and patient care, and our insurance system harbors an enormous number of health system middlemen to support “non-real” work (16 positions for every one physician – half with no clinical role).

What we do have are $4 trillion already committed (albeit
badly misallocated), a remarkable array of educational institutions, a
dedicated network of public health schools and practitioners, under-utilized
nurses and pharmacists, and a testing ground of 50 different states.

The true impact of spiraling health care costs
and their secondary effects—including stagnant wages, income inequality, a lack
of job mobility, high rates of medical bankruptcy, the closure of rural
hospitals, an inability to invest in infrastructure repairs, and our growing national
debt – is staggering. We are the only developed nation in the world that spends
more on health care than all other social services combined.

Warren Buffett, a man who knows something about sustainable growth, said recently: “The health care problem is the number-one problem of America and of American business. . . . Medical costs are the tapeworm of American economic competitiveness.”

For far too long, our leaders have focused on
how to make American corporations wealthy. But let us be clear – there is
another way. We could have the courage and the will to reapply our more than
ample health care assets and reject the status quo. We could vote in change on
a large scale.  We could elect leaders willing to honestly address a
simple, long overdue question that is at the very center of Code Blue: “How do
we make Americans healthy?”

Mike Magee is a Medical Historian and author of “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/June, 2019).

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Radiology in India

By SAURABH JHA, MD

What are the challenges of bringing advanced imaging services to India? What motivates an entrepreneur to start build an MRI service? How does the entrepreneur go about building the service? In this episode, I discuss radiology in India with Dr. Harsh Mahajan, Dr. Vidur Mahajan and Dr. Vasantha Venugopal. Dr. Harsh Mahajan is the founder of Mahajan Imaging, a leading radiology practice in New Delhi, and now a pioneer in radiology research in India.

Listen to our conversation on Radiology Firing Line Podcast here.

Saurabh Jha is an associate editor of THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner.

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Teladoc, CVS, Utilization Rates, & Apple in ‘THE YEAR of Telehealth’

By JESSICA DA MASSA, WTF Health

According to Toby Cosgrove, 2019 is “THE YEAR of telehealth.” The former CEO of Cleveland Clinic, who is currently an executive advisor to Google Cloud’s healthcare and life sciences team, proclaimed it as such to CNBC, saying that this year is “THE YEAR” telehealth becomes ubiquitous.

That’s a pretty bold statement – particularly as utilization rates for virtual visits continue to fall short of expectations – so we double-checked this prognostication with Teladoc’s CEO, Jason Gorevic.

Does he think 2019 is going to be telehealth’s
turning point?

Well, although he’d rather call the space ‘virtual
care’ instead of ‘telehealth’ (maybe this will be the difference maker?), he
confesses he’s pretty much on board with Cosgrove’s assertion that more
consumers than ever will visit virtual exam rooms this year.

But, why?

How does 2019 become “THE YEAR” of virtual care?
Is this going to be an industry-wide boon, or is Teladoc just banking on its
partnership with CVS and their new family member, Aetna?

Tune in to hear Jason get real about what’s impacting utilization rates, how things are going to change this year, AND whether or not he’s worried about competing with Apple, Google, and Amazon for screen time. (Hint: He’s not.)

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Last Couple of Months in Oncology with Dr. Bishal Gyawali: March 2019

By BISHAL GYAWALI MD, PhD

Hey, I’m back!

Well, you might not have noticed that my blogs were missing for the last three months but anyways, its good to be back. I was having a little time off blogs and social media as I was transitioning in my career but now I am back. Sometimes, it is very difficult to manage time for things that you must do versus things you enjoy doing, especially when these two don’t intersect. For me, these last few months the things I had to do were all bureaucratic while I couldn’t find the time for things I enjoy doing like writing these blogs. But now that we are back, let’s recap what has happened in the oncology world in the year 2019 so far. I can’t cover all of them, but will try to summarise the major events in oncology.

Hundred Foxes’ Howl versus One LION’s Roar

In my country, there is a saying that goes somewhat like the roar of one lion will scare hundreds of howling foxes away. In medicine, I guess, it translates as one good RCT trumps the results from hundreds of observational studies. For patients with advanced ovarian cancer, primary surgery to achieve complete resection is the most important treatment and prognostic factor.  However, what to do with the lymph nodes is a question that has troubled the oncology community for a long time. Logically, it makes sense to remove the lymph nodes too because they are the sanctuary sites for cancer cells. However, lymph node dissection carries high morbidity. Although multiple observational studies suggested a survival benefit with lymph node dissection, the LION trial, now published in the NEJM, shows that for women with macroscopic complete resection of primary tumour, lymph node dissection increases morbidity (postoperative complications) and post-operative mortality rates but doesn’t improve survival. I am glad that this trial was carried out and these results will now save many women with ovarian cancer worldwide from unnecessary harmful procedures, but I am also sad that we didn’t answer this question until now and thus, many patients suffered unnecessarily. I hope this LION’s roar scares us from jumping to conclusions based on logic or observational data alone and without RCT evidence in future. Another lesson here is the importance of public funds in supporting RCTs like these.

Practical exercises on trial methodologies and reporting

Going through oncology articles published in top journals in the last couple of months seemed more like a practical course on spotting methodological issues in publications. I don’t have the time to discuss them all here but for any student of research or trial methodologies, these papers will be good learning exercises. I have tried to focus more on statistical than clinical aspects of these trials because they are in general not practice changing yet.

First, in this phase 1/2 trial, a drug in competition for the most difficult drug to pronounce/spell in oncology, sacituzumabgovitecan-hziy, was tested in patients with refractory metastatic triple negative breast cancer. Although the responses look impressive, there is no mention of the criteria for success. Shouldn’t there be an a-priori definition of when success can be claimed for a phase 2? How do we decide when to take them to phase 3?

Second, these two RCTs of direct oral anticoagulants to prevent VTE in ambulatory cancer patients are an exercise on understanding intention-to-treat versus per-protocol treatment. Another lesson here is to look at the absolute difference in event rates besides the hazard ratio. In any case, the burden of therapy here seems to outweigh the benefits.

Third, in this RCT of TDM1 as adjuvant therapy for patients with HER2 positive breast cancer who had received a trastuzumab-containing neoadjuvant regimen but had residual invasive breast cancer, the conclusion reads “the risk of recurrence of invasive breast cancer or death was 50 percent lower with adjuvant T-DM1 than with trastuzumab alone”. The hazard ratio is 0.5 but hazard ratio is not the same as risk ratio. This is a common misconception as we have previously shown in this experiment. The difference in absolute percentage of patients who remained free of invasive disease at 3 years was 11 percent (88 percent v 77 percent) which is impressive, but it’s not 50 percent. Finally, with a median of more than 40 months of follow-up, the OS hasn’t seen significant improvement. Also a tricky question now is whether TDM1 retains the survival benefits when the disease has relapsed now that patients have already used it in the adjuvant setting.

Fourth, this RCT of ramucirumab after sorafenib in hepatocellular cancer provides multiple lessons: Clinically meaningful versus statistically significant difference in outcomes (OS benefit of only 1.2 months but p = 0.0199), highly selected patient population for enrollment (the control arm OS of over 7 months in second-line hepatocellular cancer) and the use of this sentence in the conclusion despite 3 fatal adverse events and an increased percentage of serious adverse events within the ramucirumab arm: “Ramucirumab was well tolerated, with a manageable safety profile.” If you don’t know why I am not happy with this statement, please read this article we published in the BMJ that addresses this exact point.

Another drug that improves an endpoint that you didn’t even know existed until few years ago

Darolutamide has shown to improve metastasis-free survival in patients with non-metastatic castration-resistant prostate cancer in the ARAMIS trial.  Metastasis-free survival is a new surrogate endpoint, about which I have discussed in detail in an earlier blog. To be fair, unlike enzalutamide, darolutamide has also shown improvements in overall survival but only 15 percent of the patients in placebo arm received enzalutamide subsequently. When this trial was presented at ASCO GU 19, the discussant Prof. Ian Davis’s summary slide which nicely highlighted all the caveats floated around Twitter, so I will just put his slide here: https://twitter.com/birensaraiya/status/1096175780579561472.

Also, while we are talking about prostate cancer, I’d like to highlight this study which showed that the combination of radium plus abiraterone was harmful than abiraterone alone. Another example to keep in mind to remind ourselves to exercise caution in recommending A B when both A and B are approved agents for a given cancer.

We need more publicly funded trials

An important trial in glioblastoma was published in the Lancet in February. Until now, the Stupp regimen has remained the standard of care but this new RCT of Stupp regimen plus lomustine showed a significant improvement in OS of 17 months compared to Stupp regimen alone without lomustine. The sample size was small and the authors conclude the abstract as “Our results suggest that lomustine-temozolomide chemotherapy might improve survival compared with temozolomide standard therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter. The findings should be interpreted with caution, owing to the small size of the trial.” I totally appreciate the honest interpretation from the authors here but also can’t help wonder how this paragraph might have read if this was the trial of immunotherapy instead of lomustine and funded by industry rather than the German Federal Ministry of Education and Research.

Let me take a selfie

After a long time, Vinay Prasad and I have written a paper together. This time we talk about risk-benefit trade-offs in the adjuvant treatment setting, especially in the absence of robust data, because the threshold for treatments are different from the metastatic setting. We also list various examples of drugs that are effective in metastatic setting but failed as adjuvant therapy.

Dr. Gyawali is a research fellow at Program On Regulation, Therapeutics And Law (PORTAL) at Brigham and Women’s Hospital/Harvard Medical School. The opinions expressed herein are his own. This post originally appeared on ecancer here.

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You Lose a Child, You Lose Your Job

By LEO LOPEZ III, MD

I’m a physician, born in McAllen, Texas. In June 2018, I returned home to demand that immigrant children who had been torn from their families as a result of the Trump Administration’s zero-tolerance policy, be safely and immediately reunited. I demonstrated at a federal detention center in McAllen at the Free the Children Protest. I marched alongside other concerned citizens, and we confronted a bus carrying the children.

With my palms pressed against the bus, I demanded that the government free them. I could not have imagined that just a few months later, I’d demand that the government find them. 

Back then, the Office and Refugee and Resettlement had just certified that over 2,600 children had been separated from their families. 

The Office of Inspector General (OIG) of the Department of Health and Human Services recently released an updated account. They actually weren’t sure how many children were separated. Turns out they didn’t count them. According to the report, HHS doesn’t know exactly if, when, or how they’ll find the lost children.

I grew up right there, along the south-Texas border, and I know that cattle are better accounted for than these infants and children.

So whose fault is it? In my opinion, the blame falls on Health and Human Services Secretary Alex Azar and Homeland Security Secretary Kristjen Nielsen, both of whom are ultimately responsible for executing the President’s policy agenda through their respective departments. The Department of Homeland Security (DHS) systematically separated families. The Department of Health and Human Services failed to identify the children who were separated. 

To me, our moral duty is clear. We must demand that the secretaries resign immediately.

When former Health and Human Services Secretary, Tom Price, was found to have inappropriately used private jets and military aircraft for travel, he was forced to resign. We found his misappropriation of jet fuel morally reprehensible. And yet, Secretary Azar and Secretary Nielsen lost thousands of children and are still unpunished and fully employed.

The haunting silhouette of children staring back at me through the tinted glass windows of the bus is etched in my memory. I grew up with kids like them. But there are Americans who are less sentimental. I know that there are members of my community who support the zero tolerance policy and would likely resist calls for the resignation of those who implemented it. 

But in this case, the justification to call for resignation seems simple and non-partisan: 

If you lose a child, you lose your job.

Leo Lopez III, MD is a fellow at the National Clinician Scholars Program of Yale University.

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