The Health Care Blog – Page 394 – Everything you always wanted to know about the Health Care system. But were afraid to ask.

Above the Fold

Why Does the FDA Approve Cancer Drugs That Don’t Work?

Oct 22, 2015• 5

By BRIAN KLEPPER

A new study in JAMA Internal Medicine finds that two-thirds of cancer drugs considered by the US Food and Drug Administration (FDA) over the past five years were approved without evidence that they improve health outcomes or length of life. (This study closely corroborates and acknowledges the findings published last year by John Fauber of The Milwaukee Journal Sentinel and Elbert Chu of MedPage Today.) Follow-up studies showed that 86 percent of the drugs approved with surrogate endpoints (or measures) and more than half (57%) of the cancer drugs approved by the FDA “have unknown effects on overall survival or fail to show gains in survival.” In other words, the authors write, “most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points.”

The use of surrogate endpoints in the approval process is at the heart of this issue. Drug companies argue that these alternative measures permit smaller, cheaper and faster clinical trials, allowing desperately needed drugs to get to market faster. Demonstrating efficacy with “harder” measures like overall survival – whether someone actually lives longer as a result of the drug – is a higher bar that requires more time and resources.

Many drug company representatives argue that the shortcut is not only acceptable but desirable. A 2011 Genentech white paper on oncology endpoints opens with this headline:

“…such surrogate endpoints as objective response rate and progression-free survival have been employed because they can be reached faster and may offer important benefits in evaluating therapies.”Continue reading…

Disruptive Idiots From Silicon Valley

Oct 21, 2015• 23

By SAURABH JHA, MD

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Recently, I was dining with elite radiologists. In that uncomfortable silence between dessert and the check, I said “radiology must shift the traditional paradigm by creating value streams using disruptive innovation to leverage population health to build strong ecosystems and a robust ectoplasm.”

I was experimenting if excreted verbiage hastens the check. Instead, it sparked a vigorous conversation about disruptive innovation, compelling me to drink more cognac.

In healthcare, no two words have been as mercilessly cheapened by overuse as “disruptive innovation.” This is a shame. Disruption is serious scholarship by Clayton Christenson who studies the diffusion of technology. Christenson astutely observed that when the technology (disrupter) which renders its predecessor obsolete arrives, it is cheaper and (usually) of lower quality. It is by virtue of its lower quality it can be cheaper, and by virtue of its low cost it appeals to a neglected segment of the market.

Disrupters appeal to our moral sense of social justice. A start-up brings a giant corporation to its knees -how cool is that? It’s like David taking on Goliath (with a little help from venture capitalists).

The Time-Warp

Oct 20, 2015• 12

By JONATHAN BUSH

John Gage, Sun Microsystem’s fifth employee and its former chief researcher, famously said “the network is the computer.” The majority of us experience this every day through interactions with a wide variety of highly-intelligent, super-connected networks including Facebook, which remembers our friends’ birthdays better than we do; ATM networks, which know instantly if we have the cash that matches our request; and the complex, yet seemingly simple interweaving of phone networks, which allows us to communicate smartphone-to-smartphone regardless of carrier. Sadly, healthcare struggles to grasp this important concept.

Earlier this month, I flew to Utah for a conference hosted by KLAS, a major healthcare research outfit, about interoperability. Interoperability is a clunky word that’s talked about endlessly in healthcare, but at its root is an important notion: health care information needs to flow freely. Interoperability means that important information isn’t stuck in proprietary enterprise software that a hospital spent millions of dollars buying years ago. Having this information in the right place at the right time equates to reduced risk of medical errors and makes the delivery of health services more efficient and less costly. I’m convinced more than ever the only way to free information from the silos where it’s currently stranded is for the industry to embrace connectedness by switching to cloud-based, open networks.

The goal is clear. Yet healthcare IT executives and those buying their products remain stuck in the old ways of thinking. In their minds, software is still the computer, and sunk costs keep it so. As such, health information is largely trapped on technology islands that are maintained at great expense onsite at hospitals across our country versus flowing across the care continuum via a universally available information network. Just how bad is the data jam? An Epocrates’ survey earlier this year of nearly 3,000 physicians found that only 14 percent of physicians can access usable electronic health information across all care delivery sites and six out of 10 doctors, even when in the same organization, aren’t effectively sharing information.Continue reading…

ONC’s Interoperability Plan: a Day Late and $19bn Short

Oct 20, 2015• 1

By TOM GIANNULLI, MD

Earlier this month, the Office of the National Coordinator for Health Information Technology released an update to Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap. The roadmap was first announced back in January, and the changes shared this month aren’t significant.

Ultimately, it calls for all healthcare providers nationwide to be able to send and receive electronic clinical information by the end of 2017.

This is a good plan on the surface, although it comes six years and millions of dollars late, and like other programs it may be more cumbersome that it first seems. Essentially, there are three facets:

1) Data standards to format and request/receive data

2) Incentives (again!)

3) Governance

Despite the intention to move data across the Union, each state will have the right to create its own unique rules on how to manage the exchange of information. This is a problem as we have seen before in the simple Case of e-prescription routing. A few states make it almost impossible to send e-scripts and layer on their own special form of bureaucracy. This inhibits the ultimate goal of reducing costs and errors and increasing Efficiency at the expense of both providers and patients.

Right Care Action Week – What can Radiologists do?

Oct 20, 2015• 1

By SAURABH JHA, MD

The Lown Institute advocates rational use of medical resources. This is a noble goal and worthy of the attention of radiologists. This week is the right care action week. Here are five simple things any radiologist can do this week, and the following weeks. This will improve patient care by avoiding unnecessary tests.

Speak to the referring clinician, at least sometimes, if not often, perhaps twice a day. The conversation need not be adversarial. Ask before the imaging two simple questions. What will you do if the test is positive? What will you do if the test is negative? Inquire four weeks after the imaging is done if the study changed the clinical management. Inquire politely displaying academic curiosity not, judgmentalism. Appropriate use is a two-way street.

Don’t call pulmonary hypertension if the main pulmonary artery is > 3.1 cm on CT. Yes, I know this is the threshold, but thresholds are arbitrary. The chances that you will pick up pulmonary hypertension incidentally in someone with a 3.2 cm main pulmonary artery are dwarfed by the chances of an unnecessary right heart catheterization to confirm that the pulmonary hypertension was never there. It’s not fun having a right heart catheterization, even though cardiologists are really nice people.

Follow the ACR guidelines on the management of incidental thyroid nodules. Remember, if you pick up a papillary carcinoma of the thyroid, chances are that this will be overdiagnosed. Just ask the South Koreans. Be daring and bury the nodule in the “body” of the report, not the “Impression.”

Don’t leave the decision to following an incidental adrenal nodule, which is over whelmingly likely to be benign, on CT in an eighty year old to the referring clinician by saying “MRI may be obtained if clinically indicated.” Take ownership of the decision. Do we really believe that net societal suffering is reduced by doing chemical shift MRI on adrenal nodules on octogenarians? We are simply diverting their limited time on this planet from their grandchildren to the magnet.

God invented radiologists so that he could not be ruled out. The hedge is important, on occasion. The hedge cannot be a way of life. Please stop saying “sub segmental pulmonary embolism cannot be excluded.” Sub segmental pulmonary embolismis often an overdiagnosis. Let’s save our hedges for real monsters. On a similar note, just say “normal.”

Radiologists can reduce societal burden of too much medicine. We know the Axis of Futility, by heart.

Saurabh Jha is skeptical by nature not because he hates you. He can be reached on Twitter @RogueRad

The Dangerous Patient Safety Delusions of Eminence-Based Medicine

Oct 19, 2015• 7

By MICHAEL L. MILLENSON

The eminent physicians Martin Samuels and Nortin Hadler have piled onto the patient safety movement, wielding a deft verbal knife along with a questionable command of the facts.

They are the defenders of the “nobility” of medicine against the algorithm-driven “fellow travelers” of the safety movement. On the one side, apparatchiks; on the other, Captain America.

They are the fierce guardians of physician autonomy, albeit mostly against imaginary initiatives to turn doctors into automatons. By sounding a shrill alarm about straw men, however, they duck any need to define appropriate physician accountability.

Finally, as befits nobility, they condescend to their inferiors. How else to explain the tone of their response to the former chief executive officer of Beth Israel Deaconess Medical Center, Paul Levy? As for patients, Samuels and Hadler defend our “humanity.” How…noble.

To me, healing the sick is an act of holiness, not noblesse oblige. Fortunately, we Jews cherish a long tradition of arguing even with God Himself. A famous Talmudic story ends with God acknowledging that even Divine opinion isn’t enough to override the rule of law. Let’s take a closer look at Samuels’s and Hadler’s opinions in relation to the rules of medical evidence.Continue reading…

The Last Checklist

Oct 17, 2015• 4

By ANNA REISMAN, MD

Earlier this year, when my mother was briefly hospitalized, nobody gave her the wrong medication (her wristband was checked before each medicine was dispensed). Nobody missed a high or low blood pressure (her vital signs were taken every few hours, like clockwork). She was usually assisted to the bathroom so she wouldn’t fall (a sensor on her bed triggered an alarm if she started to get up).

Thank goodness for hospital-based checklists, now ubiquitous in large part thanks to Atul Gawande’s bestseller The Checklist Manifesto, which have succeeded in knocking down the numbers of pressure sores, blood clots, falls, infections, and other errors and complications. As a doctor myself, I’ve heard many stories about close calls where checklists were crucial: just the other day, a colleague told me about a biopsy specimen that was almost logged in as the wrong patient; by following a simple checklist, what could have been a catastrophe was downgraded to a near-miss.

And yet during my mother’s hours in the emergency room, the staff seemed uninterested, overworked, and unavailable. We had no sense that any particular person knew what the others were doing. One doctor told us that she would definitely be admitted, while a nurse told us that discharge was imminent.

Why Watson May Not Be Quite the Great Civilizational Advance IBM Says It Is

Oct 16, 2015• 8

By PAUL LEVY

The joke goes like this:

Sherlock Holmes and Dr. Watson decide to go on a camping trip. After dinner and a bottle of wine, they lay down for the night, and go to sleep.

Some hours later, Holmes awoke and nudged his faithful friend.
“Watson, look up at the sky and tell me what you see.”

Watson replied, “I see millions of stars.”

“What does that tell you?”

Watson pondered for a minute.

“Astronomically, it tells me that there are millions of galaxies and potentially billions of planets.”

“Astrologically, I observe that Saturn is in Leo.”

“Horologically, I deduce that the time is approximately a quarter past three.”

“Theologically, I can see that God is all powerful and that we are small and insignificant.”

“Meteorologically, I suspect that we will have a beautiful day tomorrow.”

“What does it tell you, Holmes?”

Holmes was silent for a minute, then spoke: “Watson, you idiot. Someone has stolen our tent!”

The High Cost of High Cost

Oct 16, 2015

By ROB LAMBERTS

“You don’t charge enough.”

I’ve heard this from a lot of folks. I’ve heard it from my accountant (of course), other doctors, consultants, and even some of my patients. I’ve had some patients who are especially complex offer to pay me more because of the difficulty of their care. I think they feel guilty and worry I’m upset that they are being “too demanding” for what they are paying. I don’t ever take extra money.

When I recently told an elderly patient’s family that I was willing to do house calls if/when the woman needed it, their question was: “how much extra does it cost?” No extra charge, actually. They were delighted at how “old fashioned” I am. Yep, Dr. Smartphone is certainly old fashioned.

How Proposed New Rules Could Change the Anesthesia Care Team

Oct 16, 2015• 1

By KAREN SIBERT, MD

I admit, I was taken aback at the headline in the Houston Press:

“Going Under: What Can Happen if your anesthesiologist leaves the room during an operation.”

The curious reader is bound to wonder why the anesthesiologist would leave the operating room in the first place.

Of course, reporter Dianna Wray explains that in many hospitals, one physician anesthesiologist often supervises multiple cases staffed by nurse anesthetists. This model of care is called the “anesthesia care team“, and has a very long record of safe practice in nearly all major hospitals in the United States. Typically, the anesthesiologist makes rounds from one operating room to the next, checking on each case frequently, just as an internal medicine physician would round on patients in the hospital who are being monitored by their nurses.