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I’m going to be announcing some big changes on THCB and with my overall services in the next little bit. So to prepare for this, here’s a rather good explanation I did last year in Australia of what I mean by SMACK.health — randomly the interviewer was Jessica DaMassa with whom I now do #Healthin2pt00 — Matthew Holt

Digital health-using SMAC (Social, Mobile, Analytics and Cloud) in health care | HISA Studio @ HIC - YouTube

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By ASHLEY ANDREOU

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? The HIV epidemic reversed the reduction of infectious disease deaths in children and young adults and, as a result, stunted the epidemiological and demographic transition, particularly in sub-Saharan Africa. Consequently, preventing HIV and other major infectious diseases became the focus of the Millennium Development Goals (MDGs) set in 2000. Likewise, in 2001, the United Nations General Assembly committed all governments to prioritizing the HIV epidemic, shelving the issue of NCDs for the next decade. Accordingly, the World Health Organization (WHO) and UNAIDS updated their “Strategies for the Prevention and Control of Diseases” to reflect this HIV and infectious-disease focused agenda; within this document, NCDs were not mentioned.

This concerted advocacy and mobilization around HIV/ AIDS gave way to an international surge of funding that gave millions of people in low-resource settings access to antiretroviral therapy (ART). Although this global movement to fight AIDS came too late for many, today HIV/AIDS is largely seen as a manageable condition rather than a death sentence.

Analyzing how HIV was internationally addressed offers important lessons on the barriers, and potential points of intervention, for NCD treatment, such as cancer.  Although a similar end point needs to be reached in the fight for cancer care—high quality, affordable, accessible, sustainable treatment—there are different pharmaceutical barriers to addressing cancer in low- and middle-resource settings.

Once adequate health systems are in place, medicine is indispensable for treating and managing NCDs. However, the pricing, development, and administration for cancer drugs are markedly different than that of HIV. An important point of divergence between HIV treatment and cancer treatment is the level of generic competition: generics were integral in making ART internationally affordable.

Many cancer treatments are biologics (i.e. a virus, therapeutic serum, toxin, antitoxin, hormone or protein, including monoclonal antibodies or similar products used to diagnose, prevent, treat or cure a disease) rather than small molecules (i.e. small, chemically manufactured active-substance molecules). New cancer medications are increasingly biotechnology products, meaning they are produced using living systems such as plant or animal cells, bacteria, viruses, and yeast. In contrast, the treatment for HIV/AIDS, antiretroviral therapy (ART), is a small molecule drug. This means that the research and development (R&D) process as well as regulatory landscape is different. This has a significant impact on how generic versions of cancer treatment are made and regulated.

For a manufacturer to obtain marketing authorization and WHO prequalification of generic versions of a drug, they must simply demonstrate interchangeability. For small-molecule products, relatively simple bioequivalence studies establish interchangeability, such as testing a compound’s melting point. Approving generics does not require fully repeating  efficacy and safety clinical trials. However, the regulatory requirements for biologics are different.

Due to their biological nature, biosimilars are never the exact same molecule. As a result, the repeat tests to demonstrate interchangeability with the originator are much more extensive. For FDA approval, biosimilar companies must repeat clinical trials that may have taken the originator company upwards of five years and hundreds of millions in investment to complete. As a result, biosimilars cost much more to produce than traditional small-molecule generics and require significant investment by the generic producer. The immense cost for biosimilar R&D is a large part of why there is a lack of generic competition and, thus, the high, monopolized prices of cancer therapy.

Reduction of cancer mortality will be suboptimal without treatment. Like HIV drugs, cancer treatment must be affordable and reliable. However, given the biologic nature of many cutting-edge cancer therapies, the current approval process for generic cancer drugs is inadequate. As such, regulatory agencies need to acknowledge that the current approval process is effectively acting as a barrier for generic competition in the cancer drug market. If we envision a future where cancer treatment is as widely accessible as ART, health organizations need to start prioritizing NCDs as much as they do infectious ones—streamlining the biosimilar drug approval process is a necessary first step.

Ashley Andreou is graduate student in the MPH program at Yale University

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In this edition of Health in 2 point 00, Jessica DaMassa asks me about enterprise sales (Qventus, Medicity, Health Catalyst), DTC vs Enterprises as a market, the VA allowing nationwide telehealth,, and the TEAP & TEFCA frameworks (that last answer may have overran the 2 minutes a tad!) — Matthew Holt

Health in 2 Point 00, Episode 24 - YouTube

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By MATTHEW HOLT

Another day, another $30m round in health tech. On Monday Qventus raised that from Bessemer Partners, with Mayfield, Norwest and NY Presbyterian kicking in too. That brings their total to $43m in so far–not bad for a 75 person company that is in the somewhat obscure space of using AI to improve hospital operations. Qventus sucks in data and delivers operational suggestions to front line managers. Of course given that somewhere between $1-1.5 trillion goes through America’s hospitals each year, there’s huge potential for saving money. And given that most hospitals are being paid fixed cost per case, anything that can be done to improve throughput and increase productivity drops to the bottom line and is thus likely to meet interested buyers. I talked to CEO Mudit Garg about the problem, his company’s solution and what they were going to do next.

Mudit Garg, CEO Qventus - YouTube

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By DAVID SHAYWITZ, MD

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.

RCTs: Golden But Not Perfect

Yet, as Bothwell has eloquently highlighted, RCTs aren’t perfect. For one, not all interventions lend themselves equally well to this approach. While drug studies generally work well (because it’s relatively easy to provide a consistent intervention in a blinded fashion), this can be more difficult, Bothwell observes, in areas such as surgery and psychotherapy.

Another challenge associated with many RCTs is the lengthy cycle time. It can take so long to conduct a study that by the time the results are reported out, science and practice may have moved on; Bothwell notes that by the time much-anticipated COURAGE study of bare metal stents was published, many practitioners were already enthusing about the next big thing, drug-eluting stents.

In addition, the subjects who enroll in clinical trials – as highlighted in a recent Health Affairs article published by authors from Flatiron, Foundation Medicine, and the FDA – may not be representative of either the larger population or of the patients who are likely to receive the intervention currently under study; groups underrepresented in clinical trials include the elderly, minorities, and those with poor performance status (the most debilitated).

This begins to get at what may be the most significant limitations of clinical trials: the ability to generalize results.   The issue is that clinical trials, by design, are experiments, often high-stakes experiments from perspective of the subjects (most importantly — it’s their health and often their lives at stake!), as well as the sponsors, who often invest considerable time and capital in the trial.   Clinical trial subjects tend to be showered with attention and followed with exceptional care, and study investigators generally do everything in their power to make sure subjects receive their therapy (whether experimental or control) and show up for their follow-up evaluations. Study personnel strive to be extremely responsive to questions and concerns raised by subjects.

But in real practice, YMMV, as they say on the interwebs — your mileage may vary; adherence is less certain, evaluation can be less systematic, and follow-up more sporadic. Conversely, an astute clinician may have figured out a way to make a medicine better, perhaps implementing a helpful tweak based on a new paper or an empiric observation. Thus the performance of a therapy in a clinical trial may rigorously, scientifically benchmark the potential of a new therapy, compared to a control, but not necessarily predict it’s actual real-world performance.

The Challenge Of Assessing Real World Performance

In fact, assessing a product’s real world performance can be surprisingly difficult; in contrast to a clinical trial, which is designed explicitly to follow each patient’s journey and to methodically, conscientiously observe and compulsively track a number of pre-specified parameters, the data available for real world patients is, while perhaps more plentiful, captured in a far less systematic fashion.

The principle vehicle of real world clinical data capture, the electronic health record, was designed to support billing (primarily) as well as the provision of clinical care (eg affording providers access to test results and previous visit notes). Additional contemporary sources of real world data – as nicely summarized in a recent McKinsey review – include administrative/claims data (organized around billable services) and increasingly, patient-generated data (such as from wearables like Fitbits).

Organizing and analyzing data – hmm that seems like just the sort of thing at which today’s tech companies excel, at least outside healthcare. Google’s stated mission is to organize all the world’s information; Amazon leverages sophisticated analytics to optimize the consumer’s purchasing experience. But healthcare, as we all know, can be a troublesome beast. Healthcare data are notoriously fragmented; quality is uneven at best; and the approach to health information privacy doesn’t lend itself to a value system based on asking forgiveness instead of permission.

Even so, tech companies big and small are pouring into the real world evidence (RWE) space; what do they hope to accomplish?

Why Tech Is Embracing RWE

The recent (earlier-cited) Health Affairs paper led by authors at one of the most advanced and successful companies in this space, Flatiron, offers a roadmap of sorts. Using a combination of technology and manual data extraction and classification, Flatiron attempts to generate near-clinical-research grade data from oncology EHR records, supplemented with other data – “most notably, mortality data from national and commercial sources,” according to the authors. (For more on Flatiron, and its recent acquisition by Roche for $2.2B, see here; for discussion of two other oncology data companies, see here.)

In addition to enabling broader patient representation – affording greater visibility into patient outcomes in groups traditionally underrepresented in clinical trials – robust RWE can potentially change the approach to at least some clinical studies by offering the possibility of what Flatiron calls a “contemporary” control arm, and what others like Medidata’s Glen de Vries, who is also keenly interested in this concept, describes as a “synthetic control arm.” The idea is that under some circumstances, it might make sense from a pragmatic perspective and/or from an ethical perspective not to randomize patients to a control arm – for example, if the disease is uniformly fatal, and without known treatment. Under select circumstances, perhaps a clinical trial could be conducted comparing patients receiving a new treatment to the RWE data of patients receiving best available treatment – especially since there are 2017 data from Pfizer and Flatiron showing, at least in the example studied, that their RWE data lines up exceptionally well with recent data from the control arm of an RCT. The implication is that if these RWE could be used in place of a control arm, an RCT could be performed much faster and cheaper – and it might be extremely attractive to participants because everyone would receive the active treatment, and no one would be randomized to the control.

There’s at least one example of this playing out; according to a recent article by Justin Petrone in Nature Biotechnology, Flatiron’s RWE “greased Roche’s path to regulatory approval.” Petrone continues,

“The company relied on Flatiron data to expand the label for Alecensa (alectinib), a treatment for people with non-small-cell lung cancer, to 20 countries. Regulators outside the US wanted more information on controls, and it might have taken Roche a year to satisfy those requirements through another route.”

While the potential of RWE is clearly starting to capture the imagination, many physicians caution that interest in RWE shouldn’t occur at the expense of the RCT gold standard. “As a clinician I would not treat without RCT,” tweeted MGH cardiologist Chris Newton-Cheh, noting “Random, blinded allocation is best protection against biased treatment allocation and confounding.” Or, as Farzad Mostashari tweeted, with characteristic charm, “You will never know the unknown confounders that randomization protected you against. It’s like Batman.”

Even so, RWE –- as described so nicely in the McKinsey review — offers an opportunity to “evaluate new treatments when randomization to placebo for clinical trials may be impossible, impractical, or unethical.” The FDA, for its part, notes,

“In some cases, a “traditional” clinical trial may be impractical or excessively challenging to conduct. Ethical issues regarding treatment assignment, and other similar challenges, may present themselves when developing and attempting to execute a high quality clinical trial. Analyses of RWD [real world data], using appropriate methods, may in some cases provide similar information with comparable or even superior characteristics to information collected and analyzed through a traditional clinical trial.”

While robust RWE isn’t likely to displace the RCT, it may lower the threshold for provisionally embracing an early positive RCT result, knowing that the treatment’s real world performance would be reliably and rapidly evaluable.

Robust RWE also affords the opportunity to better understand other aspects of a product’s performance, including it’s cost (versus other treatments), the populations it seems most effective (enabling the sort of work the led to the approval of pembrolizumab (Keytruda) for patients with high microsatellite instability – for more see here and here), as well as an understanding of populations where it isn’t working, which could lead either to additional labeling restrictions from regulators and/or additional prescribing limitations by payors. Pharma companies would be well served by seeking to substratify in advance, rather than discovering rather quickly after launch that robust RWE suggests a more restricted addressable population than the product team had anticipated.

RWE: Less Prestigious Than RCT, But More Useful?

Thus far, we’ve considered robust RWE as a somewhat imperfect alternative to the scientific gold standard, RCT. But if you take a step back, you might ask why this benchmark takes priority over what may be a more relevant standard – how a product performs in the real world. (As I joked on twitter, this reminds me a bit of a comment biochemists used to make to us yeast geneticists when we saw something in cells not recapitulated in their highly reduced system – a phenomenon they termed, tongue in cheek, an “in vivo artifact.”)

Consider this example: if I wanted to develop a new drug that could reverse type two diabetes, I’d need to prove it worked in two robust RCTs, vetted by the FDA, before I could market it to a single patient. Yet, Virta, a behavioral health company (see here), has a supervised low-carb program they report reverses type two diabetes, and have presented data from a non-randomized trial involving self-selected patients. Unquestionably, a much lower standard.

Yet on the other hand, Virta, and tech-enabled service companies like it, are likely reimbursed (at least in part) only if they deliver particular results – only if they reverse diabetes (and thus reduce costs) in a certain number of patients.  Isn’t this, at some level, a higher standard; a pill just has to show it could work to merit reimbursement; Virta actually has to deliver results.

Chris Hogg, a former pharma strategist who is now COO of the digital health company Propeller Health pointed this out on Twitter, noting that service offerings tend to require from payors “proof of use/retention” as well as “proof the solution works in their specific environment.” He adds, “You could flip it to say pharma _only_ needs to show efficacy in highly controlled settings, but services require that and proof of efficacy in real-world settings. Bar might actually be higher for new services.” (Note: tweets quoted in this post lightly edited for clarity).

Health consultant Andrew Matzkin (of Health Advances) then chimed in, “But pharma also has to prove safety to a degree that is just not relevant for most digital health. For digital health, that’s a feature, not a bug, with advantages for patients and for businesses/investors. Flipside is lack of established pathways for payment and distribution.” He added, “And I think that soon, drugs will be held to account for real world efficacy too as RWE becomes better and more widely accepted. Once that happens, the advantages of digital health (with real efficacy data) will be even starker.”

Matzkin continued, “I think the model will be provisional approval and coverage based on less RCT data, followed by RWE monitoring that could result in restricted $ and/or rescinded label indications. So a little different. But real world outcomes will matter. For everything.”

As Mazkin says, it’s hard to imagine that the ability to measure the performance of an intervention in a trusted, near-real-time fashion wouldn’t profoundly disrupt both pharma and healthcare. Moreover, while the opportunity for potentially faster approvals would seem like a real win for pharma companies (and inevitably of concern to industry critics), it’s likely that such a capability – a real world, real time dashboard of exactly how each medicine and treatment is performing in real patients – could also threaten pharma, for all the right reasons.

Drugs that fail to make a difference in the real world would be rapidly surfaced, as would some subtle safety issues. Performance-based drug contracting, which historically was always discussed but seldom implemented due to the challenge of refereeing, could potentially be meaningfully enabled by trusted real-world reporting. Conversely, new medicines that don’t seem meaningfully different in an RCT setting could turn out to be much more effective in a real world setting if they are actually better tolerated and embraced by actual patients. In addition, approaches (digital or not) that impact real world performance would likely be prioritized as well, and optimization could occur continuously, informed by reliable RWE.

In short, at its best, real world evidence provides an opportunity to evaluate medical interventions on what arguably matters most – real world performance; and evidence delivered reliably and in near real time would provide a meaningful incentive to optimize on this foundational measure, potentially bringing patient, provider, payor, and manufacturer into better alignment, while also sharpening what are likely to be real remaining differences, such as determining the value of a particular increase in performance.

A Dynamic Balance

Which brings us to my last question: what is the optimal role of RCTs in a world with quality, trustworthy RWE (not that we’re quite there yet….). The reflexive answer, of course, is RCTs for everything, followed by RWE. Perhaps this is right, though I wonder if there are circumstances when it’s preferable, or at least permissible (perhaps because the risk is low, as Matzkin suggested in the context of digital health interventions) to develop a less robust clinical trial evidence base, and focus on delivering, and optimizing real world performance.

My hope is that, unlike our tribal politics, we approach this question with humility and nuance, sensitive to the idea that the “right” approach might vary by circumstance. Figuring out the right balance here promises to be a difficult and dynamic process, a challenging problem with which we should all be grateful for the opportunity to wrestle.

David Shaywitz is a Senior Partner with Takada Ventures and a Visiting Scientist at Harvard Medical School. 

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By PRADHEEP J. SHANKER, MD

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.

Why is this important? Some have raised other scenarios in which health care providers supersede the decision making of parents, for the welfare of the child. I personally have used the example of a bleeding child of a Jehovah’s witness, who was prevented from getting a blood transfusion. A similar example would be a child with a severe deadly infection, like meningitis, being prevented from receiving life saving antibiotics because of religious reasons.

However, that wasn’t the issue in this case. There was no path which provided a clear method to improve the child’s prognosis.  All the choices in front of the decision makers were about treating a child that had no long term prospects whatsoever. In the court proceedings, all sides agreed on the medical facts of the case, including the parents. So this was very different from the cases above, for that very reason.

So, what was the primary intent of Alfie’s doctors, if not to cure him, or prolong his life?

The primary intent stated over and over again in court documents was the focus on reducing Alfie’s suffering to the minimal amount possible.

The ethics of suffering is a deep and complex issue, in and of itself. A widespread view, especially in non-Western traditions, is that “happiness” consists of the absence of suffering. In Hindu and Buddhist belief, tranquility or contentment are amongst the most valued sentiments.

However, there is a distinction to be made between an obligation not to cause suffering and an obligation to prevent suffering. Suffering-focused ethics is a belief that places primary or particular importance on the prevention of suffering. Most views that fall into this category are pluralistic in that they hold that other things besides reducing suffering also matter morally.

The problem with suffering based ethics is, the absolutist view of such thinking takes you to strange, even dark, places. For example, some countries have begun to start programs that actively intend on…eradicating Down’s Syndrome. Down’s Syndrome  is a genetic defect cause by Trisomy 21, which causes mental defects and delayed intellectual maturity, among other issues. Some societies have deemed it ‘suffering’…for such people to exist.

For most people, this is an extremist view that seems unacceptable. Even in the UK, support for such a policy is a minority position. But again, if your primary goal is to reduce suffering, in any sense of the word…then there is a sort of dark logic to it.

Therefore, if you feel that such a policy is going too far…you are admitting that suffering cannot be used an absolute criteria for making end of life decision. You are basically stipulating there are other issues that also matter.

The UK court and the Royal College of Pediatricians itself reviewed the question of when it was appropriate to remove life sustaining medical assistance, and came up with three clear scenarios. The first is when death is immediate and/or imminent; that was not the case here, as Alfie survived for several days even without ventilator assistance. A second reason is informed consent for withdrawal of treatment; the parents actually opposed withdrawal of support.

Now here is the remarkable point: the third reason, the argument they finally made, and that the judge finally accepted in this case, states that even if absence of suffering or pain, if life is limited in quality, support can be removed; in short, the child would be better off dead than alive.

Now, this is problematic on several levels.

First…what is the scientific basis of quality of life? Is there some medical method to quantify how much ‘quality’ of life exists in a person, objectively?

Obviously, the answer is ‘No’. The physicians, and the judge in the case, are making a faith based decision.  They are basing this on their own moral, religious, and personal beliefs. There is no practical scientific method they are pursuing here.

If suffering is not critical to making this decision, what is?  Who exactly are we benefiting in such a case?  We are not benefiting the child.  The people benefiting are the doctors, the medical system, possibly the parents.  The judge is stipulating here that the child’s benefit is not necessarily critical in these cases. That is a shocking admission.

Frankly, I would have preferred a more logical and sensible medically based argument from the government and the court. The judge repeatedly made unscientific claims to defend his position. For example, at one point when the parents wanted to fly the child to Italy, the judge claimed that the flight may itself cause seizures. Notably, he never provided any evidence for this claim. It was a irrational statement, based on nothing, and because he was the judge…such irrational non-scientific claims were acceptable.

A second sound, logical, but harsher argument: that in a system such as the UK NHS, where there is limited funds to take care of everyone, the needs of the many outweigh the needs of the few, and therefore, rationing care makes sense. At least that would be a logical explanation of their decision. The decision, as it stands, lacked logical cohesiveness, and certainly has no objective science basis.

The second major philosophical issue in this case is the concept of parental rights, and how paternalism in medicine is a growing trend. This case illustrates the worst abuses of the archaic medical philosophy of paternalism.

Paternalism is the belief that physicians and medical professionals, being more educated and knowledgeable about health issues, should decide what is in the patient’s best interests, without regard to the patient’s own wishes.

Paternalism was a common practice among doctors before the middle part of the 20th century. But as individual freedoms grew in the Western world, patient autonomy (the belief that patients were intelligent and knowledgeable enough to make decisions for themselves) became predominant.

Paternalism becomes problematic as you further and further narrow the rights of parents to make medical decisions for their child. This process has a long history in the United Kingdom. In England, the Supreme Court has ruled that in any legal conflict about what is in a child’s best interest, the child must have an state appointed ‘voice’. This was an abuse of an original law that was passed to help care for children when two parents disagreed over the care of a child, especially in divorce proceedings. It has now grown to mean the government can interfere with decisions, even when both parents agree.

The specifics of the legalities aside, what becomes an issue for medical providers is, where do parental rights start, and where do they end?

Defenders of the NHS and physicians in this case continue to argue that to reduce Alfie’s suffering even one iota is moral. That in and of itself is not as white and black as it appears at first glance, as argued above. To compound this error, the judge specifically states suffering of the child is not necessary to remove life sustaining medical efforts.

If as the judge says suffering of the child is not necessary to remove parental rights, what exactly is the ‘red line’ he is willing to draw to protect parental rights? In short, he is admitting that there is no such line. The whims of the court and doctors, in his opinion, can always supersede any wishes of the parents, with logic, reason, or medical evidence notwithstanding.

Once there is no clearly definable limits to parental rights, what the UK is generally saying is that no true parental right exists. The simple fact is, they are reducing the concept of parent rights to a new definition: parental rights until such time the government decides it is inconvenient. That is no right at all.

For physicians, this is extremely problematic. Physicians rely on the decision making of families, because we have deemed them as the best arbiter of the feelings and intent of the patient. If that isn’t the case anymore…where does that leave us?

This leaves us with a gray area in which Alfie was likely to die, and likely to die very soon.  His suffering was not dramatically more or less with one course of action versus another, no matter how hard his physicians were trying to claim it as such.

So ultimately, when this is distilled down to the basics, the question largely resides on whether you believe parental rights are a true cornerstone of society…or those rights are simply a suggestion that can be ignored upon the whim of government officials and doctors, based on their own flexible moral code.

It would be another matter if there was clear evidence of harm with the parental choices.  If a parent is abusive, or illogical, then the state may have the right to intercede. But short of that evidence, where is the evidence that doctors somehow have a superior moral code to the parents? We have already shown that medical evidence was not the pre-eminent basis for making the final decision to pull all medical assistance to Alfie…and as such, all that is left is morals and faith.

Ultimately, physicians must realize that their knowledge, regardless of how extensive it is, is limited. Science can only go so far. And frankly, doctors must admit they are flawed. Some argued that the parents were so emotionally invested, they couldn’t possibly make a logical choice in this situation. But any physician that has treated a child knows, we are human and we are emotionally invested too.

In their piece on The Case For Suffering-Focused Ethics, Lukas Gloor and Adriano Mannino put it this way:

Given the difficulty of this task, it is important that we do not make it even more complicated by placing unreasonable formal demands on our values. Likewise, it is important that we do not hastily subscribe to some particular view without remaining open to reflection. Ultimately, choosing values comes down to finding the intuitions and guiding principles we care about the most – and if that includes a number of different intuitions, or even some form of extrapolation procedure to defer to better-informed future versions of ourselves – then the solution may not necessarily look simple. This is completely fine, and it allows those who agree with (some of) the intuitions behind suffering-focused ethics to care about other things in addition.

Nations must decide for themselves whether or not they think parents are the cornerstone of their society. The right of a parent to make decisions for their child is one of the most basic belief systems that is universal throughout the world.

Physicians are experts on medicine and science. What they are not experts on is values, religion, ethics and personal morality, and they shouldn’t pretend to be experts on such things. And in cases where the science leaves us questioning the truth of the situation, and we are left in a gray area of doubt and uncertainty, physicians would be well served to openly admit their limitations, and defer to the people most fit to make such determinations: a patient’s loved ones.

About the author:

Pradheep J. Shanker M.D., M.S. is a practicing Diagnostic Radiologist in Columbus, Ohio. In addition to medicine, he is an activist on health policy and educational reforms.

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In this start your weekend off right edition, Jessica DaMassa asks me about Andy Slavitt’s new Town Hall venture fund announced at HLTH, the ATHN buyout, Novartis paying Michael Cohen, Trump’s drug price speech & Lyra Health’s $45m raise….all in 2 minutes–Matthew Holt

Health in 2 Point 00 Episode 23 - YouTube

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By STEVEN FINDLAY

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.

Indeed, PBMs appear to be squarely in the administration’s sites.  Drug companies  pay rebates to insurers and PBMs to assure their drugs get on formularies, and sometimes a preferred spot on a formulary.  

Up the same alley, the two officials have proposed that Medicare Part D insurers be compelled to pass along rebates to Part D enrollees—something the pharmaceutical industry supports.  Insurers now pocket most of the rebates.  One idea: require Part D plans to pass along at least a third of rebates to enrollees.   

Not surprisingly, insurers don’t like that idea.  They argue that it (a) doesn’t force drug makers to reduce the list price of their drugs and (b) could actually raise costs for many seniors because insurers would pass the rebates along to high drug utilizers while raising premiums for all enrollees.  

This stuff is complex, folks; it’s a marketplace and not a transparent one!   

Less likely from the president is any proposal to end the legislative ban on direct government (Medicare) drug price negotiation with pharmaceutical companies.      

Up in the air is importing and buying drugs from other countries, such as Canada.  Trump has supported this idea in the past but Azar and Gottlieb strongly oppose it. 

Trump has also railed against other countries skating off U.S. innovation in drug development.  As is well known, most EU and developed countries negotiate and cap the price they’ll pay for medicines on behalf of citizens.  That prompts drug companies to seek the bulk of their profits in the laissez-faire U.S.—the country where the bulk of the world’s biomedical research and drug developments is done.   

No fair, Trump asserts.  But will the administration want to further strain relations with EU allies around trade policies in light of the trade and tariff debate he recently triggered.   EU countries have also been very clear on any suggestion that they pay more for drugs because the U.S. is unwilling to negotiate drug prices: No Way!    

One thing’s for sure:  the pharmaceutical industry is not going to relent in its long-standing opposition to drug price controls.  See this piece from Monday’s New York Times.    

Mounting Public Outrage 

The industry’s efforts are, however, up against mounting public outrage.  Even amid the chaos of the past year around ACA repeal and replace, anger about drug prices has not gone away.  Media attention is constant (See this “60 Minutes” piece from last Sunday) and a recent Kaiser Family Foundation poll found more people complaining about drug prices than health insurance costs. 

The public’s anger has been compounded in the last couple years by the opioid epidemic and widespread media attention to drug company’s complicity in promoting excessive use of narcotic pain pills.  

Recent lawsuits and congressional hearings on this have also raised the prospect of legislation to place restrictions on the companies that distribute drugs.   Pharmacy chains have put the industry on notice, too, that they’ll get tough when they have to. Walmart announced this past week that it will provide no more than a seven-day supply of first-time opioid prescriptions. 

Also this week: 30 California counties joined dozens of other states, counties and cities nationwide seeking recovery for alleged taxpayer losses from the makers and distributors of opioid painkillers.   A giant aggregated class action suit is underway that has been compared to the 1990s tobacco industry case.  

Politics 

Politics is also at play in all this.  Drug prices are almost sure to be a potent issue in the mid-term elections.  Nearly everyone agrees something needs to be done and both Republicans and Democrats stand to gain from campaigning on the issue and pushing solutions.   

For Republicans, it’s a chance to pivot from repeal and replace and show they are still focused on health care costs.  For Democrats, dumping on big pharma is tried and true—an evergreen.  Republicans know they must blunt Democrats’ advantage on the issue. 

For Trump, this is also a pivot, from ACA bashing to an issue he campaigned on and seemed genuinely vexed about—and one that struck bipartisan cords and was at odds with Republican pro-pharma orthodoxy and thus showing his independence from the party.    

(It doesn’t help, though, that the speech comes the same week Trump’s lawyer, Michael Cohen, was revealed to have had a $1.2 million consulting contract with drug giant Novartis.  Cohen promised to help the company gain access to Trump and other administration officials, a Novartis employee told the news organization STAT.   Novartis let the contract lapse earlier this year and says now it was “a mistake.”)

An RFI – Really? 

The possibility of an RFI (request for information and ideas) sounds awfully much like a delay tactic—where Trump and Republicans can punt the issue to after the mid-term elections while saying they are doing something.  Democrats probably won’t complain about that, however, since they want drug prices as a campaign issue and any legislative action this year is highly unlikely.  Also, if they—the Democrats—regain control of the House and/or Senate they’ll have a much better shot at bolder legislation.  

There’s certainly no dearth of ideas already in the public domain, including those discussed at length in these three recent reports (easily available via Google), just to cite a few: 

  • Making Medicines Affordable: A National Imperative; National Academy of Sciences, 240 pages, 2017  
  • “Reforming Biopharmaceutical Pricing at Home and Abroad,” a report from the Council of Economic Advisers, February 2018
  • “High-Priced Drugs in Medicare Part D: Diagnosis and Potential Prescription,” a National Bureau of Economic Research working paper, January 2018. 

The journal Health Affairs also released three insightful “policy option” papers in March 15 authored by leading academics and experts on drug costs. You can access them for free under “Featured Content” at healthaffairs.org

All these reports and papers note prominently that incremental ideas won’t be enough to prevent substantially higher prices and costs for brand name medicines in the future.   That is being driven by very welcome science—e.g. the new biotech cancer immunology drugs.   But these medicines seem to get more expensive every year.   And that’s limiting access.   

Also, at present, there’s no clear pathway to transition a $200,000 a year brand name cancer drug to a $10,000 a year drug once it comes off patent.   The companies set up to produce such generic biotech drugs (sometimes called biosimiliars) are more inclined to charge in the $120,000 to $170,000 range.  In Europe, they are ordered to charge far less.   

Some of the new biotech drugs will be magnificent breakthroughs.  But they could also break the bank—with rising costs for government, employers and consumers. 

As with other health care debates these days, this one is about the balance of power between government and industry.   It’ll also a debate that pits public health and access to needed medicines against private sector profit.    

More later after we hear what the President has to say.  

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By MATTHEW HOLT

This week was the very flash, very well marketed and apparently rather fun HLTH conference. As you might guess, given I’ve run a somewhat similar conference in a similar space for the past decade and this was the biggest market entrant in years, I was paying alot of attention, even though I wasn’t actually there. So I started writing a few tweets yesterday morning which basically became the equivalent of a blog post–so I made it one here!

  1. Since the fuss about & success of #HLTH2018 I’ve been thinking a lot about the role of health tech conferences and in some ways @HLTHEVENT is a perfect metaphor for the health care system as a whole  /1
  2. Bear in mind I co-founded & still am co-chair of @health2con which when it started was regarded as revolutionary & different – so this is tinged with professional envy. Also bear in mind that I was at #ythlive this week so didn’t actually go to Vegas. So grains of salt /2
  3. What @HLTHEVENT did was convince virtually every CEO who’s ever presented at @health2con @WHCCevents @hdpalooza etc over the past decade to come speak in Vegas at an unknown conference–albeit one that had a ton of money to burn, and great connections via VC @oakhcft /3
  4. Given the crap I’ve received over the years from certain CEOs who only want to keynote @health2con & were instead asked to be on a panel, or worse were put in a break out, I’m amazed they pulled it off. But they did & it seems all were happy /4
  5. OK, here’s the metaphor part. Once #HLTH2018 achieved essentially a “health tech co CEO monopoly” (for 4 days in one place), they were able to act like a health system that’s done the same thing with its providers & hospitals (cough cough @UPMC @SutterHealth et al)  /5
  6. There was an abundance of marketing before and during #HLTH2018 (roadside billboards, massive web advertising), tons of new technology (400 speakers got their own moving caricature, high end back screens more akin to the Grammys or stadium rock show) but same basic format /6
  7. And like #HLTH2018 the health care system as a whole loves marketing its “transformation”, loves its flashy new technologies (MRIs –> CyberKnives –> Robotic surgery), but fundamentally hasn’t changed its structure, process or product in 80 years /7
  8. Also the list price at #HLTH2018 for a large conference was 2 x that of @health2con & 3 x that of @HIMMS (albeit no food included there), on the way to @TEDMED @ExponentialMed or @hepsummit /8
  9. And in health care, new fancy buildings, tech, drugs and services also raise the average price /9
  10. minor promotional note — at @health2con Fall conference this year we have reduced the price as we’re trying to get more “regular” hc people there /10
  11. Back to #HLTH2018 — while the agenda/lineup was great, the format was #manels (will get back to that), speed dating of VCs/providers/startups, and hackathons. All done v. Well but not exactly news /11
  12. What wasn’t there at #HLTH2018? Well as @halletecco pointed out, only 18% of speakers were women, and I’m sure the % of CEOs who were women once you take out journalists, VCs etc was way lower /12
  13. Who else wasn’t there. As tech CEO/COO @ThePatientsSide noted, no patients on stage at all. I know it’s hard & @HLTHEVENT isn’t trying to be @StanfordMedX or even #Patients2.0, but hard to imagine the “future of healthcare” with no patients /13
  14. Last in what wasn’t there was live tech on stage–particularly in the 4 minute demo format. Good! I don’t want anyone to compete with @health2con on that! But it also means few new/small innovators in the limelight compared to Blue Cross CEOs (still love ya @GanzMark!) 14
  15. So the question of whether there’s room for a new kid on the health conference block has been answered. But unless there’s voodoo accounting going on, #HLTH2018 lost a ton of money /15 (more later)
  16. Traditional new conferences start small & make money, then grow incrementally. Sometimes that takes a looooong time–@HIMSS took 25 years to get to 3,000 people /16
  17. That’s a metaphor for the wider health care system. It takes 25 years for apparently anything to incrementally change & often disruptive change fails (e.g capitated med groups in 90s)  /17
  18. @HLTHEVENT is trying the @amazon /Silicon Valley approach. Grow fast, lose money, take market share and make profit later. Of course anyone who has tried that in health care has basically failed /18
  19. And I can’t tell if it’s ignorance or an inside joke homage but the very name HLTH is the same as the stock ticker of the 90s poster child for that approach. Healtheon was going to revolutionize health care, even had a Michael Lewis book about it /19
  20. Of course the ultimate impact of all that hubris was a consumer website @webmd full of generic information that you can get in lots of places (including from the Feds) spread over multiple pages to maximize drug advertising /20
  21. So what about #HLTH2018? Is it a brilliantly marketed, well executed event that’s designed to be flipped to the highest bidder on 2-3 years? Previous history from the @money2020 team suggests so /21
  22. Or is it going to really help catalyze or reflect a significant change in how health care works? You don’t have to be as depressed as @VentureValkyrie or @jayparkinson to realize that we are still a long way from any realistic transformation. /22
  23. In some ways the signature announcement from #HLTH2018 was that a major Democratic health figure @ASlavitt (of whom I’m a big fan) started a VC firm to invest in services for the poor & underserved. Think about that. (Oh & bizarrely it’s named the same as a right wing blog!) /23
  24. Now even that isn’t a new idea , @chcfinnovations has been doing it for nearly a decade. But it’s an long odds bet that venture money will fix the health experience of the poor & underserved /24
  25. So take it from someone who has been watching this for 30 years. At some point I HOPE the weight of technology & new models will sweep away the current health system. But there are no guarantees  /25
  26. I’ll end with #HLTH, not @HLTHEVENT but the CEO who took Healtheon public in 1998. Mike Long was interviewed at @health2con 6 years ago. /26
  27. He said that his new company @Lumeris was designed to change the system quickly as he was in his 60s and he saw his personal use of health care was going to skyrocket /27
  28. So hopefully @HLTHEVENT & the rest of us are going to really move the needle on the former HLTH CEO’s future health care experience. And the experience for everyone else. /28
  29. But we are still a long way from that transformation being real for most of us. And far too many players in health care (as @GanzMark reminds us) are only in it for the $$ /29

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By BILL ROSENBERG

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. Whereas the federal Medicare program covers almost 40 million people in one basic plan (Parts A + B), private payers’ purchasing power is highly fragmented. The latter payers offer over 100,000 health insurance plans to cover 155 million workers, an average of 1,550 workers per plan – or about 5,000 individuals per plan (including family members). One 500-pound gorilla representing 40 million lives should and does pay lower prices than 100,000 plans covering an inconsequential 5,000 lives each and, not to be forgotten, Medicare’s administrative costs are about 2% compared to 10% to 20% for employment-based plans.

So, why not let Medicare rent its network and discounts to private employers for a fee? Such a public-private partnership would have many advantages for both employers and the federal government. Employers would continue to provide health coverage – whether insured or self-insured — to their workers, but would save on claim costs by paying substantially lower health care prices. In other words, employees would have the same plan as Medicare beneficiaries, but the payments to hospitals and doctors would come from the employers and employees as is the case today, and would be much lower.

The federal Medicare program would benefit from this arrangement in two ways. First, it could charge a fee to employers for access to its network and plan design and thereby defray Medicare’s cost to taxpayers. Employers undoubtedly would be pleased to spend a few cents on the dollar to save 30 or 40 cents. And the addition of private-pay, pre-age-65 lives to the Medicare covered population would enhance the ability of Medicare to achieve even bigger volume discounts. Remember, doctors and hospitals are not required to participate in Medicare, but most do because they cannot afford not to.

Some may be concerned that the Medicare Public Private Partnership Plan sounds suspiciously like “Medicare for All,” or “Single Payer,” but that concern is not warranted. The difference here is that the Medicare Public-Private Partnership would be voluntary and not a government mandate. This a critical element because the only thing Americans like less than their current high-cost health coverage is the fear of losing it. “If you like your plan you can keep it” arguably was a fib critical to the passage of the Affordable Care Act.

Employers know how to introduce new health coverage. They demonstrated their prowess in this regard by moving millions to Managed Care in the 1980s and 1990s and millions more to Consumer Directed Care after that. They know how to craft incentives to get employees to try the new plans and then gradually to replace the old with the new. They could offer supplemental plans if needed to make the new Medicare Public-Private Partnership option actuarially equivalent (or slightly better as an incentive) to what their workers have now and still save billions. Employees would find Medicare’s lower out of pocket costs and the largest national network of participating hospitals and doctors very attractive. Instead of the tag line seen at 2012 presidential debates, “keep the government out of my health care, but don’t touch my Medicare,” the pitch could be, “keep the government out of my health care, but let me have Medicare.”

Bill Rosenberg is a health care consultant in Mount Vernon, ME

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