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This is a guest post from Carolyn Thomas:

An Open Letter To All Hospital Staff

Dear hospital employees,

After a particularly bizarre experience undergoing a treadmill stress echocardiogram at your hospital recently, I decided to do something that I have never done before: I called the manager of the cardiology department to complain about her staff. (Incidentally, a recent opinion survey of international tourists found that Canadians were #1 in only one category: “Least likely to complain when things go wrong” — so you can appreciate that lodging an official complaint is a fairly big deal here!)

In my best PR fashion, I told the manager how distressing the appointment had been because of the behaviour of the two cardiac technicians in the room. It’s not so much that they were openly rude, but it was their insufferable lack of people skills that had pushed me over the edge. No introductions, no eye contact, no consideration of how awkward this test can be, no explanation of  the test procedures or even the flimsiest effort at polite conversation. To them, I was merely the 1:00 o’clock appointment, the obstacle between them and their next coffee break, just a piece of meat on a slab — but worse, an invisible piece of meat. Read more »

Who’s Against Comparative Effectiveness Research?

DrRich’s valued colleague R. W. Donnell, who writes Notes From Dr. RW, has responded to a recent post in which DrRich bravely came out in favor of Comparative Effectiveness Research, even at the cost (DrRich asserted) of alienating the majority of the more conservative-leaning components of his readership.

Dr. RW, noting DrRich’s claim that conservatives have laid out a formal policy of opposition to CER, says:

“OK, stop. Where are these people, conservatives or those of any ilk, who have taken a position against CER? Dr. Rich cites groups who are skeptical and very concerned about the new political agenda for CER, not CER itself.”

Dr. RW is, of course, correct. Research that compares the relative effectiveness of medical procedures or treatments is not only inherently a very good thing, but also is a form of research that has a long and proud history.  Healthcare would be an even more dire activity than it is today without the large body of research that guides physicians in making recommendations to their patients when more than one option is available. So yes, comparative effectiveness research is obviously a valuable and time-honored endeavor, and for anyone (conservatives or anyone else) to come out against it would be akin to coming out against babies, or bunnies. (Though, as one whose effort to grow vegetables has been severely challenged each year by a pride of aggressive rabbits, DrRich, as it happens, is indeed against bunnies.)

So, to reiterate, neither conservatives nor anyone else are really against comparative effectiveness research, just as Dr. RW asserts.

What they are against is Comparative Effectiveness Research. They are against a new government bureaucracy that sets the CER agenda, whose stated goal is to create a more efficient and less expensive healthcare system, and that will have the authority to determine what gets reimbursed and what doesn’t.

Dr. RW has made it plain that he is not confused about the following point, but many are: There is a difference between comparative effectiveness research (whose unambiguous goal is to compare the clinical effectiveness among different treatment options, so as to offer physicians objective guidance in making clinical decisions, and which is as unassailable as babies and bunnies), and Comparative Effectiveness Research (which is to be operated by a new government bureaucracy, whose agenda regarding what kind of effectiveness is actually to be compared is intentionally ambiguous).

The ambiguity of CER (as compared to cer) was made clear recently when Peter Orszag testified on behalf of the administration before the Senate Finance Committee. When queried by skeptical Republicans on the ultimate goal of the proposed CER board, Mr. Orszag was evasive. Specifically, when asked by Senator Kyle (R-Arizona) whether the CER board would be empowered to make decisions on which medical services will be reimbursed, Mr. Orszag finally replied, “Not at this point,”  a reply which did not alleviate the suspicions of the minority party.

To state the ambiguity more plainly, it is clear that while the CER board will mainly be concerned about comparing “cost effectiveness” (which is the only way they can potentially achieve their main goal of reducing healthcare costs), the only kind of effectiveness they are willing to discuss publicly is “clinical effectiveness.”

This studied ambiguity allows proponents of the new government plan to paint opponents of the CER board as being against the “babies and bunnies” form of comparative effectiveness research, and thus reveal those nay-sayers as being beneath contempt, unworthy of anyone’s attention. Meanwhile they will be free to advance their real “cost effectiveness” agenda.

DrRich agrees with conservatives that this kind of deceptive ambiguity is indeed contemptible. But really, it is no more contemptible than the thousands of other forms of covert healthcare rationing we see all around us. (Covert rationing inherently relies on ambiguity – saying we’re doing one thing while all the time we’re doing another.)

Having tried to clarify this distinction between cer and CER, DrRich will now repeat that his prior post was not merely to express support for the “babies and bunnies” variety. As Dr. RW points out, everybody is in favor of that kind of comparative effectiveness research.

Rather – and this is where he further jeopardizes his continued tolerance by his conservative readers – DrRich is offering his support to the other kind of CER, the kind described in the stimulus bill, which (though the administration will not say it publicly) will undoubtedly use comparative effectiveness research to perform cost effectiveness calculations, then coerce physicians, through one form of federal subterfuge and intimidation or another, to employ the least expensive therapies.  The government bureaucrats, just as they are doing today but with less muscle, will shout “quality” while enforcing “cost.”

DrRich supports this kind of CER not because it is a good thing – it decidedly is not. He supports it because here is a form of covert rationing that will at last effect everyone, and will be so blatant that after a time even us Americans will no longer be able to ignore it, try as we might.  DrRich believes that relatively soon, we would notice that here is a cadre of unelected bureaucrats rationing our healthcare – determining which of us lives and dies – through some opaque process, and lying to us about it the whole time. He believes this to be the pathway most likely to get the American people to finally face the fact of healthcare rationing, and to goad them into an open debate on the best and least harmful way to accomplish it.

Go ahead. Call him a cock-eyed optimist.

*This blog post was originally published at The Covert Rationing Blog*

Comparative Clinical Effectiveness Research: Setting Priorities At The IOM

What would it be like to have most of healthcare’s key stakeholders in one room, and allow each of them to take turns at a podium in 3 minute intervals? It would be like the meeting I attended today at the Institute of Medicine.

The goal of this public forum was to allow all interested Americans to weigh in on prioritization rankings for comparative clinical effectiveness research (CCER). CCER, as you may recall from my recent blog post on the subject, is the government’s new initiative to try to establish “what works and what doesn’t” in medicine. Instead of answering the usual FDA question of “is this treatment safe and effective?” We will now be asking, “is this treatment more safe or more effective than the one(s) we already have?”

There are many different treatments we could study – but let’s face it, 1.1 billion isn’t a whole lot when you consider that some CCER studies (like the ALLHAT trial) cost upwards of 100 million a piece. So we have to think long and hard about where to channel our limited resources, and which treatments or practices we want to compare first.

The public forum attracted most of the usual suspects: professional societies, research organizations, industry stakeholders, health plans, and advocacy groups. But the imposed time limit forced them to really crystallize their views and agendas in a way I’d never seen before.

I “live-blogged” the event on Twitter today and if you’d like to see the detailed quotes from all the presenters, feel free to wade through the couple of hundred comments here.

For those of you more interested in the “big picture” I’ll summarize my take home points for you:

Almost everyone agreed that…

  1. The process for establishing research priorities should be transparent and inclusive of all opinions.
  2. More information is good, and that CCER is a valuable enterprise insofar as it provides greater insight into best practices for disease management.

Most agreed that…

  1. Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
  2. CCER should be considered separately from cost effectiveness decisions.
  3. One size doesn’t fit all when it comes to patient needs and best disease treatments.
  4. Physicians should be included in the CCER research and clinical application of the findings.
  5. Research must include women and minorities.
  6. CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
  7. CCER should build upon currently available data – and that all those who are collecting data should share it as much as possible.

Some agreed that…

  1. There is a lack of consistent methodology in conducting CCER.
  2. We need to be very careful in concluding cause and effects from CCER alone.

The best organized 3 minute presentations:

In my opinion, the industry folks had the best presentations, followed by a powerful and witty 3 minutes from the American Association for Dental Research. Who knew the dentists had such a great sense of humor? Here are the top 4 presentations:

#1. Teresa Lee, AdvaMed – best all around pitch. In three short minutes, Teresa persuasively argued for transparency in CCER priority-setting, presented her top disease research picks (including hospital acquired infections and chronic diseases like asthma, diabetes, and clinical depression), the importance of physicians and patients making shared decisions about care (rather than the government imposing it), and the need to distinguish CCER from cost effectiveness.

#2. Randy Burkholder, PhRMA – “Without physician input, the questions we pose via CCER will not be clinically relevant.”

#3. Ted Buckley, BIO – “What’s best for the average patient is not necessarily best for every specific patient.”

#4. Christopher Fox, American Association for Dental Research – he said that “his good oral hygiene made it possible for him to deliver his presentation today.”

Most innovative idea

Dr. Erick Turner of Oregon Health and Science University suggested that FDA trial data be used as the primary source of CCER-related data analysis rather than the published, peer-reviewed literature since journals engage in publication bias – they tend to publish positive studies only.

Most shocking moment

Merrill Goozner, from the Center for Science In The Public Interest, essentially told the public forum hosts that the event was a terrible idea. He suggested that industry stakeholders were inherently biased by profit motives and should therefore not be allowed to influence the IOM’s CCER priority list. The crowd squirmed in its seats. For me, Merrill’s suggestion was like saying that a plan to reform the auto industry should exclude car manufacturers because they have a profit motive. Sure profit is a part of it, but reform is just not going to happen without buy in and collaboration. As I’ve argued before – there’s no such thing as complete lack of bias on anyone’s part (patients, doctors, nurses, dentists, health plans, advocates, or industry). The best we can do is be transparent about our biases and include checks and balances along the way – such as inviting all of us biased folks to the table at once.

I’m glad that happened.

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