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Death by Regulation

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By JOHN GOODMAN


“How many of you have not been able to get a drug you needed to properly deliver anesthesia to a patient?” I asked.

Every hand in the room went up.

“How did that affect your patients?” I asked. “Two of our patients died,” one woman answered.

I was speaking to a group of nurse anesthetists, enrolled in a business management program at Marshall University in West Virginia. I wish I could say their experience is unusual. It isn’t.

About 90 percent of all the anesthesiologists in the country report they are experiencing a shortage of at least one anesthetic. Drug shortages are also endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.  The vast majority involve injectable medications used mostly by medical centers, in emergency rooms, ICUs and cancer wards. Currently, there are about 246 drugs that are in short supply and, as the chart shows, the number has been growing for some time.

So what’s going on?

 

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Fulfilling the PROMISe

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By MARGALIT GUR-ARIE

A brand new EMR is being rolled out in a midsize hospital. The EMR is exclusively based on touchscreen technology, with devices strategically placed on the floor. It provides concurrent access to medical records for all team members (physicians, nurses, pharmacists, radiologists, dieticians, secretaries) wherever they may be. Patients are also accessing the EMR. They enter their own histories and describe symptoms in detail through the same touchscreen devices. This patient-centered EMR, built by a team of clinicians and technologists working together, is taking a huge step forward in Clinical Decision Support (CDS). Physicians are not only shown differential diagnoses based on what patients and other team members entered into the system, but are also presented with individualized care plans, possible side effects, dosage recommendations and drug-drug-interaction alerts, all referencing evidence available in medical literature. Longitudinal records, test results and narratives are available by problem and by patient, and the response time is never more than half a second between the thousands of screens available. The place is Vermont, and the year is 1970.

Half a century ago, when work on this EMR was taking place, Healthcare IT was on the cutting edge of technology. The Problem Oriented Medical Information System (PROMIS), the brainchild of Dr. Lawrence Weed, was pushing the envelope on every technology from hardware to operating systems, to network communications, database design and programming languages. By the time this government funded project was finally shut down, the PROMIS team dealt with such issues as mass storage, federated or single database, high availability, human interface design and networking between geographically dispersed locations. It will take several decades for the rest of the world to catch up with Dr. Weed’s, now defunct, innovation and produce something like IBM’s Watson software package, which is yet to be adapted and tested in health care. Somewhere, somehow, we took a wrong turn in Healthcare IT, and it wasn’t the much maligned billing influence, since PROMIS from day one, attempted to integrate billing in its software, with no ill effects.

 

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Rads are Good For You. Take Twice as Many.

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By PAUL LEVY

Dear Mrs. Smith, I am writing to inform you that we exposed your body to an unnecessary level of radiation during your visit to our hospital. Oh, by the way, that was two years ago. We don’t intend to do anything about this for you. Also, we have known about this problem for a long time, and we don’t expect to change our procedures for future patients. Just wanted you to know. Yours in delivering the best health care in the world, Chief of Radiology and CEO. (Jointly signed.)

That’s the essence of this article by Walt Bogdanich and Jo Craven McGinty in the New York Times. Here are excerpts:

Long after questions were first raised about the overuse of powerful CT scans, hundreds of hospitals across the country needlessly exposed patients to radiation by scanning their chests twice on the same day, according to federal records and interviews with researchers.

Double scans expose patients to extra radiation while heaping millions of dollars in extra costs on an already overburdened Medicare program. A single CT scan of the chest is equal to about 350 standard chest X-rays, so two scans are twice that amount.

 

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Health Data Discovery Contest at CureTogether

By Alexandra Carmichael


If the fine folks at Health 2.0 are any indication, contests seem to be the best way to spark innovation these days. CureTogether is throwing another contest into the mix this summer:

The Health Data Discovery Contest

Over the past 3 years, CureTogether has gathered millions of patient-reported data points on symptoms and treatments for over 500 conditions. Now it’s time to test on a larger scale how well CureTogether data represents the general population. Do they match up or not?

So we’re running a contest to tap the most brilliant stats minds out there. Challenge our dataset! See whether or not it holds up to existing research studies. Why? You’ll be helping to demonstrate the effectiveness of online platforms for medical discovery, and ultimately helping to reduce global suffering.

There are cash prizes, and the deadline to join the contest is June 29, 2011.Continue reading…

FDA Should Add a Comparative Effectiveness Arm to Final Trials

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By MERRILL GOOZNER

The Food and Drug Administration’s Prescription Drug User Fee Act is up for reauthorization next year, and so is the consumer and drug industry face-off over the contentious issue of comparative effectiveness research (CER). Consumers, patients and some physicians are demanding that CER be required of all new drugs coming to market when there are already FDA-approved therapies for the same condition. They say it will give payers and patients immediate feedback on the relative worth of the latest drugs, which are always more pricey than what preceded them, especially if the older drugs are coming off patent.

Industry opposes including CER arms in final efficacy trials. The companies claim it will place additional costs on the already expensive new drug development process; provide inadequate information for actually divining the relative worth of two competing therapies; and dissuade companies from investing in follow-on drug research, which can turn up drugs that are significantly better than older drugs.

The American Enterprise Institute’s Scott Gottlieb, who served in the FDA during the Bush administration, this week offered a lengthy brief in support of the industry position. Unfortunately, he sets up a straw man in order to knock down what could be a very effective tool for lowering the cost of medicine. It behooves industry leaders to ignore his advice, and to ignore the bleating of their marketing departments’ incessant demand for follow-on drugs.

 

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EHR Can Make the Paper Problem Worse

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By FRED TROTTER

Once a persons record has gone electronic, it really should never go back.

A paper printout of an Electronic Health Record is often huge and unwieldy. If it is printed out or faxed it creates something so huge that it is pretty impossible to be useful in a paper record.

This is the reason why need electronic interoperability solutions like the Direct Project. Without it, when a patient leaves one doctor, they have to print out an electronic record, take it to the next doctor, and then have that doctor scan the record in.

That doesn’t sound too bad until you realize that a patients printed EHR record often looks like this:

This image was provided to me by Jodi Sperber and Dr. Eliza Shulman, who generously agreed to share the photo under a Creative Commons license. Here is the full description from Flickr, which provides greater context.

An example of why interoperability is as important as the electronic health record itself.

The story behind this photo: This is a printout of a patient’s medical record, sent from one office to another as the patient was changing primary care providers. An EHR was in place in both offices. Additionally, the EHR in both offices was created by the same vendor (a major vendor); each health organization had a customized version. Without base standards the systems are incompatible. Instead, the printouts had to be scanned into the new record, making them less searchable and less useful.

Note that this was not the entirety of the patient’s medical record… Just the first batch received.

Fred Trotter is a recognized expert in Free and Open Source medical software and security systems. He has spoken on those subjects at the SCALE DOHCS conference, LinuxWorld, DefCon and is the MC for the Open Source Health Conference. He has been quoted in multiple articles on Health Information Technology in several print and online journals, including WIRED, zdnet, Government Health IT, Modern Healthcare, Linux Journal, Free Software Magazine, NPR and LinuxMedNews.

Is TV Killing Us?

By MERRILL GOOZNER

The latest Journal of the American Medical Association has a meta-analysis of the limited number (8) of studies that looked at peoples’ television habits and their relationship to incidence of diabetes, heart disease and early death. According to Anders Grøntved of the University of Southern Denmark and Frank B. Hu of Harvard Medical School, two hours of television viewing per day resulted in a 20 percent increase in type 2 diabetes, a 15 percent increase in heart disease, and a 13 percent increase in all-cause mortality. All the findings were statistically significant. In absolute terms, for every 100,000 people who viewed TV for at least two hours a day, there were an additional 176 cases of type 2 diabetes, 38 cases of fatal cardiovascular disease, and 104 deaths of any type.

Is this really a smoking gun? Correlation is not causation. What else do we know about people who watch at least two hours of TV a day? Are they depressed? Are they bored? Is their sedentary lifestyle a product of some underlying condition, which may actually be the proximate cause of the diseased state?

As the authors note in their discussion:

Although the included studies attempted to control for various known risk factors, the possibility of residual or unmeasured confounding cannot be ruled out. . . Although all of the included studies excluded participants with chronic disease at baseline, it is still possible that reverse causality may contribute to some of the associations reported herein if participants with subclinical stages of disease become more sedentary.

Karen Goozner, a certified school counselor, recently surveyed the literature that associated violent childhood behavior with watching violence on TV. The literature suggested it was a co-factor, not a causative factor. she said. In other words, families with a history of violence – who believed physicial violence was an appropriate response to social or child-rearing problems and role-modeled that behavior for their children — tended to also watch violent television for entertainment. Did the TV do it? Or was it mom or dad?

Television can be blamed for many things. Bad writing. Bad acting. But let’s not blame the escape valve for the pressures of modern life and worklife that has driven western Europeans (3.5 hours a day average); Australians (4 hours a day average) and Americans (5 hours a day average) to seek refuge in the depressing, all-night escape of drinking in front of the tube.

Another Legal Round – With a Major Misstep?

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By ROGER COLLIER

The appellate court hearing in Atlanta a week ago on the Affordable Care Act’s constitutionality, one of a series along the inevitable road to the Supreme Court, showed that the opposing legal arguments are beginning to be firmly established—with each seeming to confuse the purchase of health insurance with the purchase of health care.

The Atlanta panel of three judges, with both Republican and Democratic appointees, heard arguments for and against the earlier ruling by Judge Roger Vinson in Pensacola that the individual mandate was unconstitutional and so central to the ACA that the entire act should be invalidated, and specifically that while the Commerce Clause of the Constitution gave the government authority to regulate interstate commerce, it did not allow Congress to penalize people for the “inactivity” of declining to buy a commercial product.

Former Bush administration Solicitor General Paul Clement, arguing in support of the Vinson decision, agreed that while it could be permissible for Congress to require insurance or other payment by those being treated in an emergency room, because they would already be in the “stream of commerce,” it was a very different matter to require them to pay prospectively for future care.

 

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Obama-ney Care

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By SENATOR DAVID DURENBERGER

Tim Pawlenty used a recent appearance on Fox News Sunday to show a tougher demeanor and to prove he will not make health care cost containment and access a priority.   As Governor of Massachusetts Mitt Romney worked with the Democratic legislature and the health care industry to expand access to all residents of the state and to commit to cost containing behavior change. The coverage reforms came right out of conservative health policy playbooks at Wharton (in the 1980s) and the Heritage Foundation (in the 1990s) and the cost containment was to be accomplished by voluntary action of Massachusetts health systems and health plans. On which they have since foundered, leaving Romney to take the heat.

When President Obama made his commitment to reform of national coverage, access, insurance, payment, and delivery system policy, national Republicans refused to cooperate. The legislative policy approach he advocated came mostly from a bipartisan Senate Finance Committee report from 2008. Elements of it came from the bipartisan approach Romney took in Massachusetts. Congressional Republicans unanimously refused to participate in the process. Today every elected Republican has committed to repealing Obamacare (and now Obama-ney care).

What changed? The definition of Republican.  The election power of Sarah Palin, Michele Bachmann, Jim DeMint and the Rupert Murdoch/WSJ/Fox version of facts to bring out the “just vote No on government and on Obama” in a substantial enough minority of Americans turned the trick. While Pawlenty and Bachmann represent a state which has been committed to universal coverage and healthcare cost containment for decades, neither has done much to make it a reality in our state. Assuming “repeal and replace” implies state action is preferable to national, they’ve nothing to show for their efforts so far.

Senator David Durenberger, Minnesota, served in the US Senate from 1978 – 1995.

Five Things EHR Vendors Should Do Right Now

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By SHAHID N. SHAH

Last week I was invited to attend the second annual NIST forum for EHR Usability called “A Community-Building Workshop: Measuring, Evaluating and Improving the Usability of Electronic Health Records.” NIST, in collaboration with the ONC, unveiled its initial discussion points for what it might consider as the “Usability Criteria” in the upcoming Meaningful Use Stage 2 regulations. At the event I met with Dr. Melanie Rodney, Distinguished Researcher at Macadamian and a member of the HIMSS Usability task force; I was impressed by the work that she and her firm were doing in EHR usability space. At the NIST forum I was able to spend time with experts in the both the fields of EHRs (like me) as well as in usability and user experience (like Melanie). We learned that the government believes that while usability can be key in increasing product effectiveness, speed, enjoyment, etc., NIST is going to focus on EHR usability for the improvement of patient safety. I asked Melanie and Lorraine Chapman, Director of User Research at Macadmian, to share with us what we in the EHR technical community should do in light of what we learned at the NIST forum last week. Here’s what Melanie and Lorraine said:

While the specifics are still forthcoming, vendors have a window of opportunity today to get ahead of NIST – and ahead of competitors – by proactively addressing meaningful use in advance of the 2013 deadline. Let’s look at what vendors can do, combining the information NIST has given so far with fundamental usability best practices:

Step 1: Set Usability Goals related to Patient Safety

These are specific, measurable goals such as “Our EHR must provide a 99% error-free rate of medication entry”. NIST has given the following examples of use error categories, each of which might be driving 1 or more goals.

  1. patient ID errors
  2. mode errors [e.g., dose related]
  3. data accuracy errors
  4. visibility errors [e.g., tapered dose 80-20mg – 80 shows vs. 20]
  5. consistency errors [ e.g., pounds vs. kilos ]
  6. recall errors [e.g., 1 time dose]
  7. feedback errors [1 tablet vs. 1/4 tablet]
  8. data integrity errors [ next vs. finish to enter injection just administered]

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