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When Is Closing an Ongoing Clinical Trial a Betrayal of Participants?

We have become aware of several instances of precipitous and, in our view, egregious and unjustified closures of on-going clinical trials in which a substantial number of patients were already participating in investigational efforts, some involving biopsies for research purposes.

These closures raise serious ethical issues for the research community. We will discuss those issues and some possible changes in how trials are conducted to address the problem. It is our premise that closing on-going clinical trials without scientific, efficacy, or safety justification is an abhorrent affront to all participants in clinical research as well as a fundamental betrayal of the trust that motivates patient participants to enroll in clinical trials.

Cancer patients who accept the risk of an investigational drug are true partners in bringing new agents to market. They hope they will benefit but, regardless of personal benefit/response, they hope the researchers will learn something to help other patients. Patients participate in clinical research for multiple reasons but, particularly in the case of agreeing to undergo mandatory research biopsies, do so because the research has the potential to improve the care, treatment approach, and standards for cancer patients.

They engage in a relationship with researchers based on their trust in the integrity of the researchers and the system within which the researchers work. Any cavalier approach to the commitment patients make to research is indefensible and particularly reprehensible when participants undergo internal organ biopsies.

Violating the trust of these patients also violates the trust the patients place in the investigators, undermining patient confidence in and availability for research. That trust and any violation of it are deepened when the researcher is also a given patient’s treating oncologist.

It is with good reason that human beings who enroll in clinical trials are called participants, not subjects. A participant is one who takes part in something—an active, volitional partner or colleague. A subject is one, mouse or human, who is under the power or authority and at the incontestable will of another or others. That difference between a participant and a subject is significant and germane to this discussion of when and why it is or is not appropriate to close a clinical trial.

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New York’s Digital Health Revolution

There’s a quiet revolution going on in New York State. While the national debate continues about Obamacare and how to reduce healthcare expenditures, New York has already taken action. Thanks to a significant investment in technology and operational capacity, New York State is building a digital network of electronic medical records that will literally transform how patient care is provided and deliver major cost savings.  It’s called the Statewide Health Information Network of New York or SHIN-NY.  And, it puts New York State far out ahead of all other states when it comes to Health IT.

In a tech-savvy world, consumers want healthcare to be as easy to manage as banking, shopping and all their other utilities. They want to be involved and proactive about their own health.  In fact, a recent survey indicated that 41% of consumers said they would switch doctors if theirs did not use electronic medical records.  Now, the SHIN-NY will give patients safe and secure access to all of their records, eliminating the hassle of faxing medical records between providers, remembering their health histories and keeping track of prescriptions.

Physicians and healthcare providers will be able to make better, more informed medical decisions for their patients.  They will be able to reduce medical errors, avoid potentially harmful drug interactions and avoid duplicative or unnecessary lab and radiology tests that can add excessive cost to patients and insurance providers. Importantly, it will allow doctors to collaborate so they can coordinate care for patients that have more than one condition and see multiple physicians.

Nowhere will this be more important than in the Medicare and Medicaid population.

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Mental Health Parity and the Affordable Care Act

The Obama administration announced on Friday that it will require parity for mental health insurance coverage. That means that health insurers must apply the same copayments, deductibles, and visit limits to mental healthcare as they do for physical health care treatment. Call it fair, call it political, but please don’t call it a good economic or health policy.

The story about how this is fair, or at least politically popular goes something like this: Health insurers are evil and powerful firms that can and will do whatever they want. On the other hand, patients with mental health problems are politically weak and must be protected from the powerful insurers that have no interest in taking care of them.

In this story, the Obama administration rides in on its white stallion and rights the wrongs being perpetrated by the villainous insurance companies. All we need is a damsel in distress, an evil step-mother, and a catchy tune and Disney will sign the movie rights.

The problem with this simplistic story line is that you can replace “mental health” with nearly any other condition and the story would sound just as plausible.

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Sorry. If You Want The ACA to Work, You’re Going to Have To Actually Make People Buy Insurance

A THCB reader in New York writes in with this timely observation:

“If you want everyone to be able to get insurance, everyone has to actually have insurance.

Most people agree that one shouldn’t be denied insurance because of illness and pre-existing conditions.  This is probably the least controversial aspect of healthcare reform. The problem is, you can’t insist that insurance companies sell to all comers at reasonable rates unless you also guarantee a sufficiently large risk pool that includes the healthy as well as the sick.

If you don’t see to it that the healthy sign up, people will go without insurance until they get sick, and the pool of the insured will become so costly that premiums will quickly spiral out of control.

So, to make sure everyone CAN get insurance, everyone MUST get insurance.

This isn’t a moral or political stance, it’s not something you can choose to believe in, it’s basic economics.

The problem with the ACA’s approach to ensuring universal coverage is that the incentives for the healthy to sign up are too weak.
The healthy who decide not to purchase insurance will have to pay a penalty, but that penalty will usually be substantially lower than the price of insurance. Perversely, this weakened approach to ensuring universal coverage could make things worse than they are today.  How?

Today, if I’m healthy and uninsured, I know that if I develop a serious illness, I won’t be able to get coverage.  At all.  This is an incentive for me to go out and spend the money on insurance. Once the ACA is in full force, if I decide that I would rather pay the (cheaper) penalty than buy insurance, I have the security that should I become sick, assuming it’s not a super emergency, I will be able to get insurance to cover future costs, since policies will have to be offered to all.  This security blanket for those who choose to remain uninsured is a major problem.”

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A Plan B For Healthcare.gov?



It is now becoming clear that the Obama administration will not have Health.care.gov fixed by December 1 so hundreds of thousands, or perhaps millions, of people will be able to smoothly enroll by January 1.

Why do I say that? Look at this from the administration spokesperson’s daily Healthcare.gov progress report on Friday:

Essentially what is happening is people [those working on the fixes] are going through the entire process. As we have fixed certain pieces of functionality, like the account creation process, we’re seeing volume go further down the application. We’re identifying new issues that we need to be in a position to troubleshoot.

Does that sound like the kind of report you would expect if they were on track to fix this in less than three weeks? Their biggest problem is that they admittedly don’t know what they don’t know.

The spokesperson also reiterated the administration intends to have Obamacare’s computer system “functioning smoothly for the vast majority of users” by the end of the month.

It’s time for the Obama administration to get real.

It takes months to properly test a complex data system like this. Two things are obvious:

  1. When they launched on October 1, very little of the testing had been completed.
  2. They are now in the midst of that many months long testing and fixing period. It is clear they don’t have a few weeks of work left; they have months of work left.Continue reading…

The Art Of The Apology: What Not To Say When Things Go Wrong

There were two high-profile apologies in the news this week — by the Leader of the Free World and by a Man Who Makes Yoga Pants.

Neither was well executed and neither was well received.

Let’s start with President Obama, who offered his belated apology on the rollout of the federal health exchange at the heart of the Affordable Care Act. After more than five weeks of shifting stories, blame and timelines, the president sat down with Chuck Todd to say “I’m sorry” for repeatedly saying some variation of, “If you like your health plan, you can keep it. Period.”

Sort of.

“I am sorry that they are finding themselves in this situation based on assurances they got from me,” he told NBC News. “We’ve got to work hard to make sure that they know we hear them and we are going to do everything we can to deal with folks who find themselves in a tough position as a consequence of this.”

Critics quickly and loudly objected to the president’s use of passive voice — and the fact that he claimed people found themselves with cancelled plans “based on assurances they got from me.” They pointed out that it wasn’t the assurances that cancelled the plans; it was the way Obama’s administration wrote the regulations that required insurance companies to cancel the plans.

In short, Obama didn’t own the cause of the pain. He only apologized for the “assurances” (which, by almost all accounts, are better known as “lies”).

Now, the Man Who Makes Yoga Pants.

Lululemon founder Chip Wilson got in hot water for blaming women’s bodies for well-publicized problems with his company’s yoga clothes, including see-through pants and pilling:

“Even our small sizes would fit an extra large, it’s really about the rubbing through the thighs, how much pressure is there … over a period of time, and how much they use it,” he said.

Well, then.

This, of course, led to a predictable backlash — particularly on the company’s Facebook page, where women shared their views of the company and Wilson’s basically saying “You’re too fat to wear our clothes.”

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Information Asymmetry – The Politics of Health IT Policy

Let’s recognize Healthcare.gov as the dawn of mass patient engagement – and applaud it. Before this website, patients were along for the ride. Employers choose most of the insurance benefits, hospital web portals are an afterthought, and getting anything done with an insurance company, for both doctors and patients, means a phone call and paper. Can you imagine going online to find out the actual cost and buy anything? All that changed with Healthcare.gov.

Information is valuable and not evenly distributed. The haves are immensely valuable corporations. The have nots are patients and doctors. Welcome to the world of health IT politics where the rich get richer ($20 Billion of “incentives” have caused massive health IT consolidation and a hidden health surveillance state) and the poor get frustrated (talk to an independent physician about their EHR or to a patient trying to access her own health records).

Information asymmetry drives $1 Trillion waste of our $2.7 Trillion health care cost. That waste is about $3,000 per year per citizen.

The politics of health IT policy are not left vs. right but institution vs. individual. Politicians and regulators alike are now scrambling to understand the role of health IT policy in that $3,000 annual waste per citizen.

The asymmetry that drives health IT policy is easy to understand when you consider that health IT is sold to corporations. As physicians and patients, we do not prescribe or buy information technology and we are paying the price through a total lack of price and quality transparency.

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UCSF’s Wikipedia Experiment: Should Med Students Get Credit For Curating Medical Information Online?

You’re a loyal THCB reader. You have a symptom. You Google it. One of the first three hits will be an entry about the symptom or an associated condition on Wikipedia.

As an informed lay person, you wonder, “How accurate is Wikipedia for medical information?”

You’ve always been a little skeptical of Wikipedia, but over the years you’ve found it more and more reliable for celebrity tidbits (e.g. “How old is Jane Lynch?” or “What was the name of that guy in “Crash?”) and sports trivia (“How many Super Bowls have the Minnesota Vikings lost?”).

In fact, it’s become quite useful for understanding geopolitics, ancient and recent history, and helping explain science topics (Higgs Boson, anyone?).

So why not medicine?

We in academic medicine look down our noses at Wikipedia. “Show us original texts,” we harrumph. “Where does the original data come from?” we ask our residents and students.

Just like high schoolers and college kids are warned NOT to use Wikipedia as a research tool, medical professors hold the site lowly in regard to seriousness of purpose.

Well, it’s time to accept reality.

We all use it, whether we admit it or not. Some of us a lot. The good news is, Wikipedia’s going to get even better in the medical realm.

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Hospital Exec Pay: If P4P is Good Enough for Doctors, Why Not the CEO?

In my previous blog, I made the argument that whatever strategy we use to improve care in hospitals will not be implemented and executed well without proper focus by hospital leadership.  So, it is in this context, that we recently published some pretty disappointing findings that are worth reflecting on.

We examined the pay of CEOs across U.S. hospitals and found that some CEOs got paid a lot more than others.  This was not surprising.  CEOs of larger, urban, teaching hospitals get paid a lot more than CEOs of small, rural, non-teaching institutions.  But the disappointment was around quality:  we found no relationship between a hospital’s quality performance and the pay of the CEO.  Holding size, teaching, and other factors constant, what was the pay of CEOs of hospitals with high mortality rates?

About the same as CEOs of hospitals with low mortality rates.  What about other quality measures?  Most of them didn’t really seem to matter, with the exception of patient experience, which correlated nicely with CEO compensation.  It seems that when setting CEO compensation, patient outcomes are not a big part of the discussion.  How could this be, and why does it matter?

How you set incentives for senior managers says a lot about your priorities.  Boards generally set the salary for their CEOs and they clearly reward patient satisfaction scores.  That’s good.  They also seem to reward the things that build hospital reputations: having the latest technology such as a PET scanner or academic status.  But are boards rewarding CEOs based on mortality rates or adherence to basic quality metrics?  Not so much.  Why not?  I’ve spoken to a lot of board chairpersons over the years and the answer is not that they don’t care.  Most boards want to reward quality and believe that they do.

The problem is that most board members lack sufficient expertise on quality metrics and can’t decipher, from the large number of quality metrics, which ones are important (like mortality rates) and which ones are not.  Hamstrung, they focus on satisfaction but also end up rewarding things that feel like proxies for quality, such as having the latest technology.  And here’s the part that’s frustrating – our national efforts on quality measurement and improvement are not helping.  We seem to have done very little to prioritize what’s really important, and shine a light on them.

So what do we do to move forward?  Some states have started requiring that boards undergo training in quality.  Medicare, as a condition of participation, could certainly require that boards (or at least some members thereof) show a degree of expertise with quality.  I like these ideas but worry that training programs would themselves be of variable quality, and for some boards it would become an onerous requirement without achieving real gains in expertise.

Of course, if we really want to help boards be more effective and engage healthcare leaders, the biggest thing that we could do is actually reward hospitals, in a meaningful way, based on quality.  Yes, we have the value-based purchasing program, and it is well-intentioned.  But, as I’ve written before, it has several big problems.  First and foremost:  the incentives are very weak and there is little reason to believe it will have a meaningful impact on patient outcomes.  Second, the measures are diffuse – we have too many of them, some of which matter (mortality) and many which don’t in the absence of the appropriate clinical context (checking the ejection fraction on a heart failure patient).  It’s hard for hospital boards to really get a clear signal on what matters if they aren’t seeing it clearly and consistently from national leaders on quality.

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Hyperdiagnosis: The Wellness Industry Doubles Down on Overdiagnosis

By now we are all familiar with the concept of overdiagnosis, where “we” is defined as “the readers of THCB and a few other people whose healthcare literacy is high enough to know when not to seek testing and/or when not to automatically believe the test results.”

The rest of the country hasn’t gotten the memo that, quite counter-intuitively, many suspected clinical problems should simply be left alone.  Many insignificant conditions get overdiagnosed and subsequently overtreated, at considerable cost to the health plans and risk to the patient.

For more information on that we  refer you to the book Overdiagnosed.   The thesis of that book is that insured Americans are far more likely to be harmed by too much care than too little.

Rather than use its resources and influence with human resources departments to mitigate overdiagnosis, most workplace wellness companies have opted for the reverse, taking overdiagnosis to a level which, were they physicians billing the government for this work, could cost them their licenses and possibly their freedom.   Instead, they win awards for it.

We call this new plateau of clinical unreality “hyperdiagnosis,” and it is the wellness industry’s bread-and-butter.  It differs from overdiagnosis four ways:  It is pre-emptive.  It is either negligently inaccurate or purposefully deceptive.  It is powered by pay-or-play forfeitures.  The final hallmark of hyperdiagnosis is braggadocio – wellness companies love to announce how many sick people they find in their screens.

1. Pre-Emptive

Most cases of overdiagnosis start at the doctor’s office, when a patient arrives to join the physician in a generally good faith search for a solution to a manifest problem.  The patient comes in need of testing.   By contrast, in hyperdiagnosis, there is neither a qualified medical professional providing adult supervision nor good faith.  The testing comes in need of patients, via annual workplace screening of up to seventy different lab values.  Testing for large numbers of abnormalities on large numbers of people guarantees large numbers of “findings,” clinically significant or not.  It is a shell game that the wellness vendor cannot lose.

2.Inaccurate or Deceptive

Most of these findings turn out to be clinically insignificant, no surprise given that the US Preventive Services Task Force recommends annual screening only for blood pressure, because otherwise the potential harms of screening outweigh the benefits.  The wellness industry knows this, and they also know that the book Seeking Sickness:  Medical Screening and the Misguided Hunt for Diseasedemolishes their highly profitable screening business model.   (We are not cherry-picking titles here—there is no book Hey, I Have a Good Idea:  Let’s Hunt for Disease.)  And yet most wellness programs require annual screens to avoid a financial forfeiture.   This includes the four programs covered on THCB this year — CVS, Nebraska, British Petroleum, and Penn State.

Those four programs and most others also obsess with annual preventive doctor visits.  Like screening, though, annual “preventive” visits on balance cause more harm than good, according to academic and lay reports.  The wellness industry knows this as well.  We have posted it on their LinkedIn groups, and presumably they have also access to Google.  They addressed the data by banning us from their groups.

3. Pay-or-play forfeitures

Because of the lack of value, the inconvenience, and privacy concerns, most employees would not submit to a workplace screen if left to their own devices.  The wellness industry and their corporate customers “solve” that problem by tying large sums of money annually — $600 for hourly workers at CVS, $1200 at Penn State and $521 on average – to participation in these schemes.  Yet participation rates are still low.  At Penn State, for example, less than half of all employees got screened despite the large penalty.

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