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Above the Fold

FDA Should Add a Comparative Effectiveness Arm to Final Trials

Jun 17, 2011• 33

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.

EHR Can Make the Paper Problem Worse

Jun 17, 2011• 12

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.

Pawlenty sounding Bush-like on health care

Jun 17, 2011

AHIP is in town (as in San Francisco) and sadly that means I’m juggling the office and conference going. So altough I made the odd party I missed former Minnesota governor Tim Pawlenty (who apparently was paid $30K to speak). However, Politico’s Kate Nocera seems to think he got a bit of a tough reception from the insurer crowd which by and large is going to enjoy the ACA and has set its course on making hay from it. But whether or not repealing ACOs and the experiments with Medicare financing are really going to happen (and they’re not) I was though struck by the final quote about exchanges: ‘And Pawlenty dismissed the importance of the state exchanges the law will create to provide consumer choice. “We already have an exchange: It’s called the free market,” Pawlenty said.’ Pawlenty shows himself to be a complete idiot on the Mark Pauly scale here. (Pauly is the Wharton professor who thinks that the individual insurance market works fine because it’s more or less OK for 80% of the people in it). But doesn’t this remind you of another not-too-bright former Republican governor? Remember who said this in 2007?: “I mean, people have access to health care in America. After all, you just go to an emergency room.” Let’s hope for logic’s sake alone we don’t end up with Pawlenty in the White House, as it could be a repeat of 2001-8 all over again.

Is TV Killing Us?

Jun 16, 2011

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?

Jun 16, 2011• 10

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.

Agreeing with Michael Cannon on Medicaid, somewhat

Jun 16, 2011

Michael Cannon from Cato doesn’t like the idea that we’re going to cover children by putting them into Medicaid. To tell the truth I don’t like it either. He points to a NEJM study that shows–in the no shit, Sherlock department–that Medicaid recipients wait longer for care. My guess is that Michael’s solution is to a) do nothing or b) give Medicaid recipients a fund to pay for their own care–a fund that real life shows us will be cut as soon as budgets get tight (and as has happened nation-wide under S-CHIP). My solution is to put those kids in the same system as everyone else. But the real politics of the US is that–for now–Medicaid expansion is the best we’re getting. As soon as it’s done we should be working to abolish Medicaid by integrating it into a rational single system so that children (and adults) do not get discriminated against in medical care simply because they chose their parents poorly.

Caregivers: The Advocate and the Adminstrator

Jun 16, 2011• 1

By Matthew Holt

Just thought that I’d share this photo taken by @drjmob at the Partnership for Patients meeting today. (P4P is a safety initiative kicked off by HHS a few weeks back). Here’s patient data advocate (and BFF of Health 2.0) Regina Holiday getting to grips with CMS head Don Berwick. In fact they had remarkably similar experiences with spouses who endured terrible hospitalizations made worse by incomplete data and poor provider team communication. Here’s Regina’s story from her blog and here’s Don’s (starts on Page 20 of Escape Fire but read the whole thing if you haven’t before). It’s an unlikely couple–the pre-school teacher without a college degree and the Harvard policy wonk. But they share a human experience both are working hard to eradicate.

Obama-ney Care

Jun 15, 2011• 3

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

Jun 15, 2011• 1

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.

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

The Future of American Healthcare, Ctd

Jun 15, 2011• 6

By EVAN FALCHUK

Almost half of health plans in the US have deductibles of at least $1,000 according to a new study. It’s called “cost shifting” and it’s a big part of the future of American health care.

There are two major reasons why employers are doing this.

First, higher deductible plans are cheaper, since there is less risk to insure. Think of your car insurance – why would you make a claim for a ding on your door when it’s cheaper for you to just pay to have it fixed (or fix it yourself)? The higher the deductible, the lower the premium, even if it means more out-of-pocket cost for you for the small stuff.

Along these same lines is the second reason. If employees spend more of their own money on health care, maybe they’ll be smarter about how they spend it.

It sounds good – but does it work?

Yes. And No.

Studies show that consumers in high-deductible health plans do spend less than those in traditional plans. But, they spent less in some worrisome ways:

Childhood vaccination rates dropped. . .Rates of mammography, cervical cancer screening, and colorectal cancer screening also fell among those with high-deductible health plans relative to those in traditional plans. . . . even though high-deductible plans waive the deductible for such preventative care.

As another study put it: “Deductibles can create powerful yet potentially indiscriminate and blunt incentives for consumers to alter their care-seeking behavior.”

Of course, this is a complicated way of saying higher deductibles work, and are smart choices for employees and their employers. But the research tells us they aren’t enough.