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It was 1970. I was in my laboratory at the NIH sequencing a murine myeloma protein in order to define the structure of its antibody combining region. Studies of protein conformation were at the cutting edge of science then; enthusiasm abounded. But it was clear to me that this work, in all its scientific elegance, had little to do with treating myeloma or anything else in mice or man. The reason for all the painstaking effort was the joy of pushing back the frontier of ignorance, even if only a bit. No one could foresee clinical utility then, nor would any become apparent for decades. Today such monoclonal antibodies are widely used to treat many diseases, sometimes with efficacy that justifies the costliness.

Genomics is in a bigger hurry.

Thanks to 40 years of breakthroughs, many earning Nobel Prizes, the chromosome carrying the defective gene underlying a genetic disease, Huntington’s disease, was identified in 1983 and the gene sequenced a decade later. In short order, defective genes underlying a number of single-gene diseases were defined: cystic fibrosis, hemophilia, and others. We all wait with baited breath for these elegant insights to transform into primary treatments for single allele genetic diseases. Attempts to transfect patients with normal genes are encouraging but barely so; it has proved difficult to get the right gene to stay in the right cells. Likewise, directly modifying the abnormal genetic apparatus is still largely just promising. The fallback remains working downstream from the genetic apparatus, replacing or modifying the defective products of many of these pathogenetic genes.  Nonetheless, optimism regarding modifying the genetic apparatus itself is rational as is ever more boldness on the part of molecular biologists.

Continue reading “Hyping Cancer Genotyping”

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For all the advances in both medicine and technology, patients still face a bewildering array of advice and information when trying to weigh the possible consequences of certain medical treatments. But a hands-on, data-driven tool I have developed with some colleagues can now help patients obtain personalized predictions for their recovery from surgery. This tool can help patients better manage their expectations about their speed of recovery and long-term effects of the procedure.

People need to be able to fully understand the possible effects of a medical procedure in a realistic and clear way. Seeking to develop a model for recovery curves, we developed a Bayesian modeling approach to recovery curve prediction in order to forecast sexual function levels after prostatectomy, based on the experiences of 300 UCLA clinic patients both before radical prostatectomy surgery and during the four years immediately following surgery. The resulting interactive tool is designed to be used before the patient has a prostatectomy in order to help the patient manage expectations. A central predicted recovery curve shows the patient’s average sexual function over time after the surgery. The tool also displays a range of lighter-colored curves illustrating the broader range of possible outcomes.

This model not only shows people what they can expect about their recovery on average, based on their own specific characteristics, but it also clarifies the uncertainty in the shape of the recovery curve. It shows a range of possible realistic outcomes. We want to help patients who are considering this particular surgery to understand what they could expect. We can’t tell them exactly what their recovery will look like, but at least we can now forecast a personalized recovery curve and show them an informed prediction of their possible outcomes. The model can be used in an interactive way. For example, patients could adjust their reported age or reported sexual function levels to see how their predicted recovery curves change.

Continue reading “Using Big Data to Manage Medical Expectations”

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flying cadeuciiAfter more than a year of conspiratorial planning that would make Francis Underwood proud, California’s trial attorneys got a number assigned to an opaquely worded ballot initiative on Drug and Alcohol Testing of Doctors. Medical Negligence Lawsuits Initiative Statute As a result, “Proposition 46” could give California voters an unwitting hand in doing what this attorney group has been unable to accomplish after 40 years of inept legislative lobbying and dubious court challenges: undermine the state’s Medical Injury and Compensation Reform Act, or MICRA.

MICRA was passed in 1978 by a Democratic-dominated legislature and signed into law by then-governor Jerry Brown in response to the collapse of the state’s medical professional liability insurance market.  MICRA didn’t change the right of injured patients to obtain unlimited economic damages for all medical costs, lost wages and lifetime earnings. What it did was limit was non-economic “pain and suffering” damages to $250,000. Up until 1978, California’s trial attorneys had used this highly speculative class of damages to rake in a third of the multi-million jackpot jury awards. That made California physicians’ malpractice insurance unavailable at any price, leading many doctors to close their practices and leave the state.

That ended with the passage of MICRA. The market stabilized and in the decades that followed, billions in health care savings from lower professional liability costs were passed through to California’s patients.

Early last year, California’s physicians had heard rumors that a ballot initiative to undo MICRA’s non-economic cap was being planned.  Little did they know that California’s trial attorneys would take their cue from political consultant-bully Chris Lehane by opening their campaign with a mass mailing of anti-MICRA cadaver toe tags. That was quickly followed by the neighbors of pediatrician and then California Medical Association President Paul Phinney receiving deceptive postcards implying he was a drug dealer.

Months later, the ballot initiative – that was 100% underwritten by the trial attorneys and their allies at a cost of $2.85 per signature – landed on California Attorney General Kamala Harris’ desk.  The initiative’s authors cleverly disguised its quadrupling of the MICRA cap to more than $1 million (“to account for inflation”) and cynically camouflaged it between two conversation-changers:  1) mandatory physician drug screening and 2) mandatory uploading of the narcotic prescription history of every California patient to an online database. Naturally, Ms. Harris rewarded her trial attorney donors by making a mockery of the state’s single-subject rule and okayed it.

Continue reading “California’s Proposition 46: Trial Attorneys Behaving Badly”

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Screen Shot 2014-07-26 at 12.19.57 PMThere’s no mystery about why the July 23 execution of Joseph Wood in Arizona took so long. From the anesthesiologist’s point of view, it doesn’t seem surprising that the combination of drugs used—midazolam and hydromorphone—might take nearly two hours to cause death.

Here’s why.

The convicted murderer didn’t receive one component of the usual mixture of drugs used in lethal injection: a muscle relaxant. The traditional cocktail includes a drug such as pancuronium or vecuronium, which paralyzes muscles and stops breathing. After anyone receives a large dose of one of these powerful muscle relaxants, it’s impossible to breathe at all. Death follows within minutes.

But for whatever reason, the Arizona authorities decided not to use a muscle-relaxant drug in Mr. Wood’s case. They used only drugs that produce sedation and depress breathing. Given enough of these medications, death will come in due time. But in the interim, the urge to breathe is a powerful and primitive reflex.

So-called “agonal” breathing, which precedes death, may go on for minutes to hours. The gasping or snoring that eyewitnesses described would be very typical. People who are unconscious after overdoses of heroin try to breathe in a similarly slow, ineffective way, before they finally stop breathing altogether or are rescued by emergency crews.

More about the drugs

Wood Stay

Midazolam is a member of a class of drugs called benzodiazepines. The common “benzos” that many people take include Valium, Xanax, and Ativan. What these drugs have in common is that they produce relaxation and sleep. You might take a Xanax pill, for instance, to help you nap during a long flight.

In anesthesiology, we use benzodiazepines for another important reason: because they produce amnesia. There are stories of people taking a Valium to relax a little before they give an important talk, and the next day panicking because they can’t remember if they actually showed up and gave the talk.

Amnesia can be very helpful in my business. Many of my patients don’t want to remember coming into the operating room and seeing the bright lights and surgical instruments. After I inject one or two milligrams of midazolam into the IV, they’re often smiling and relaxed, and they have no memory later of coming into the operating room at all.  The next thing they know, surgery is over and they’re waking up.

Continue reading “No Mystery: Arizona Execution Lengthy Due to Drug Choice”

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flying cadeuciiHealthcare costs far too much. We can do it better for half the cost. But if we did cut the cost in half, we would cut the jobs in half, wipe out 9% of the economy and plunge the country into a depression.

Really? It’s that simple? Half the cost equals half the jobs? So we’re doomed either way?

Actually, no. It’s not that simple. We cannot of course forecast with any precision the economic consequences of doing healthcare for less. But a close examination of exactly how we get to a leaner, more effective healthcare system reveals a far more intricate and interrelated economic landscape.

In a leaner healthcare, some types of tasks will disappear, diminish, or become less profitable. That’s what “leaner” means. But other tasks will have to expand. Those most likely to wane or go “poof” are different from those that will grow. At the same time, a sizable percentage of the money that we waste in healthcare is not money that funds healthcare jobs, it is simply profit being sucked into the Schwab accounts and ski boats of high income individuals and the shareholders of profitable corporations.

Let’s take a moment to walk through this: how we get to half, what disappears, what grows and what that might mean for jobs in healthcare.

Getting to half

How would this leaner Next Healthcare be different from today’s?

Waste disappears: Studies agree that some one third of all healthcare is simple waste. We do these unnecessary procedures and tests largely because in a fee-for-service system we can get paid to do them. If we pay for healthcare differently, this waste will tend to disappear.

Prices rationalize: As healthcare becomes something more like an actual market with real buyers and real prices, prices will rationalize close to today’s 25th percentile. The lowest prices in any given market are likely to rise somewhat, while the high-side outliers will drop like iron kites.

Internal costs drop: Under these pressures, healthcare providers will engage in serious, continual cost accounting and “lean manufacturing” protocols to get their internal costs down.

The gold mine in chronic: There is a gold mine at the center of healthcare in the prevention and control of chronic disease, getting acute costs down through close, trusted relationships between patients, caregivers, and clinicians.

Tech: Using “big data” internally to drive performance and cost control; externally to segment the market and target “super users;” as well as using widgets, dongles, and apps to maintain that key trusted relationship between the clinician and the patient/consumer/caregiver.

Consolidation: Real competition on price and quality, plus the difficulty of managing hybrid risk/fee-for-service systems, means that we will see wide variations in the market success of providers. Many will stumble or fail. This will drive continued consolidation in the industry, creating large regional and national networks of healthcare providers capable of driving cost efficiency and risk efficiency through the whole organization.

Continue reading “Half the Cost. Half the Jobs?”

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Optimized-Ornstein

This story was co-published with NPR’s “Shots” blog.

In the name of patient privacy, a security guard at a hospital in Springfield, Missouri, threatened a mother with jail for trying to take a photograph of her own son. In the name of patient privacy , a Daytona Beach, Florida, nursing home said it couldn’t cooperate with police investigating allegations of a possible rape against one of its residents.

In the name of patient privacy, the U.S. Department of Veterans Affairs allegedly threatened or retaliated against employees who were trying to blow the whistle on agency wrongdoing.When the federal Health Insurance Portability and Accountability Act passed in 1996, its laudable provisions included preventing patients’ medical information from being shared without their consent and other important privacy assurances.But as the litany of recent examples show, HIPAA, as the law is commonly known, is open to misinterpretation – and sometimes provides cover for health institutions that are protecting their own interests, not patients’.

“Sometimes it’s really hard to tell whether people are just genuinely confused or misinformed, or whether they’re intentionally obfuscating,” said Deven McGraw, partner in the healthcare practice of Manatt, Phelps & Phillips and former director of the Health Privacy Project at the Center for Democracy & Technology.For example, McGraw said, a frequent health privacy complaint to the U.S. Department of Health and Human Services Office of Civil Rights is that health providers have denied patients access to their medical records, citing HIPAA. In fact, this is one of the law’s signature guarantees.”Often they’re told [by hospitals that] HIPAA doesn’t allow you to have your records, when the exact opposite is true,” McGraw said.

I’ve seen firsthand how HIPAA can be incorrectly invoked.

In 2005, when I was a reporter at the Los Angeles Times, I was asked to help cover a train derailment in Glendale, California, by trying to talk to injured patients at local hospitals. Some hospitals refused to help arrange any interviews, citing federal patient privacy laws. Other hospitals were far more accommodating, offering to contact patients and ask if they were willing to talk to a reporter. Some did. It seemed to me that the hospitals that cited HIPAA simply didn’t want to ask patients for permission.

Continue reading “Are Patient Privacy Laws Being Abused to Protect Medical Centers?”

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In more stunning proof that America’s 18th century style governing process just doesn’t work, a subset of a regional Federal court ruled against part of Obamacare. The Halbig ruling is certain to be overturned by the full DC court and then probably will stay that way after it makes it’s way through the Supremes–at least Jonathan Cohn thinks so.

But think about what the Halbig ruling is about. Its proponents say that when Congress (well, just the Senate actually as it was their version of the bill that passed) designed the ACA, they wanted states only to run exchanges and only people buying via states to get subsidies. But that they also wanted a Federal exchange for those states that couldn’t or (as it turned out) wouldn’t create their own. But apparently they meant that subsidies wouldn’t be available on the Federal exchange. That would just sail through Logic 101 at any high school. Well only if the teacher was asleep, as apparently most Senators were.

Now two judges interpret what was written down to imply that subsidies should only be available on state exchanges–even though logic, basic common sense and fairness would dictate that if we’re going to subsidize health insurance we should do it for everyone regardless of geography.

Don’t forget that in the House version of the bill there was only a Federal exchange. Continue reading “Halbig corpus interruptus”

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Today’s 2-1 decision by the DC Court of Appeals striking down federal premium subsidies, in at least the 27 states that opted for the feds to run their Obamacare insurance exchanges, has the potential to strike a devastating blow to the new health law.The law says that individuals can get subsidies to buy health insurance in the states that set up insurance exchanges. That appears to exclude the states that do not set up exchanges––at least the 27 states that completely opted out of Obamacare. Another nine states set up partnership exchanges with the feds and the impact on those states is not clear.The response by supporters of the law, and the IRS regulation that has enabled subsidies to be paid in the states not setting up exchanges, hinges on the argument that the language is at worst ambiguous and the Congress never intended to withhold the subsidies in the federal exchange states.

But in the DC Court ruling one of the majority judges said, “The fact is that the legislative record provides little indication one way or the other of the Congressional intent, but the statutory text does. Section 36B plainly makes subsidies only available only on Exchanges established by states.”

My own observation, having closely watched the original Obamacare Congressional debate, is that this issue never came up because about everybody believed about all of the states would establish their own exchange. I think it is fair to say about everyone also believed a few states would not establish their own exchanges. Smaller states, for example, might opt out because they just didn’t have the scale needed to make the program work. I don’t recall a single member of Congress, Republican or Democrat, who believed that if this happened those states would lose their subsidies.

Continue reading “Halbig Decision Puts Obamacare Back on the Front Burner and Will Give GOP a Massive Political Headache”

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flying cadeuciiThe answer to the doctor shortage isn’t more doctors

Yesterday, the New York Time’s Editorial Board published a piece on the shortage of physicians in the United States and what’s needed for healthcare workforce redesign.

It’s a good, concise piece about the common thinking around the gap between the needs of our growing patient population and the number of doctors available to deliver the care they need. As as an example, the article refers to a recent statement by the Association of American Medical Colleges whose models predict a shortage of 90,000 doctors in the U.S. by 2020. In Canada, the story is sometimes different where physician unemployment is growing due to inadequate infrastructure and poor workforce planning.

While I do agree that ensuring access to care is important, to think that the solution is simply more doctors comes from framing the question incorrectly.

The question shouldn’t be “how many doctors do we need for a growing population?”. Rather, the question should be “how do we care for a growing population in a cost-effective way?”

When you reframe the problem in this manner, it’s  easy to see that simply churning out more doctors isn’t the answer. In fact, with the direction healthcare is heading, those numbers are likely overestimates.

The major problem with workforce planning models is that they assume healthcare delivery of the future looks very much like healthcare delivery of the present. That the future will continue to be, in many ways, very doctor-centric.

It won’t.

Continue reading “The Answer To the Doctor Shortage Isn’t More Doctors”

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Adverse Event Reports Since 2004. Source: OpenFDA

On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.

OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16).

The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. We have held off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.

Now, I readily admit, I am biased. As a data geek with 15+ years working on Big Data problems, I really want to love OpenFDA.  It is, after all, a major step forward both in terms of technology, but more importantly, philosophy from an agency that hasn’t exactly been a shining example of either in recent years.

In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects.

But we don’t live in an ideal world.

So, here are my thoughts on the Good, Bad, and Ugly of OpenFDA:

The Good:

OpenFDA is a seal of approval over the use of FAERS data in multiple settings. This is the first time that FDA has confirmed what we have believed all along – that these data are valuable and should be used in multiple venues to improve patient safety. It has long seemed ridiculous that the FDA spends millions of dollars to collect these data, uses it for their own internal safety signaling and review processes, but then deters others in the healthcare community from deploying these same data in new and innovative ways.

OpenFDA gives the long awaited ‘all-clear’ to harness the power of these data to improve care throughout the healthcare system.   We’re excited to see how this evolves in the product space – especially at the patient level – in the months and years ahead.

The Bad:

As with any new launch, once the excitement dies down, the true capabilities and limitations of the system are revealed. After careful review we’ve discovered several major concerns, two of the big ones are detailed below:

Continue reading “OpenFDA – the Good, the Bad, and the Ugly”

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Editor-At-Large, Wellness

Joe Flower
Contributing Editor

Michael Millenson
Contributing Editor

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