The "Kabuki Play" of Monied Interests Around the $1.1-Billion Comparative Effectiveness Research Initiative, By Daphne White, CHTP

(This column was first published by John Weeks on TheIntegratorBlog.com.)

John Weeks’ Introduction:

In this section of a two-part series, Integrator contributor Daphne White, CHTP focuses on the political-economic dynamics behind the $1.1 billion "clinical effectiveness research" (CER) initiative. White examines what she calls the "Kabuki play" - intense dynamics as the medical industry seeks to gut the value of the initiative, while not appearing to do so.

Would you assume that this initiative would look at cost or would inform the care people receive? As White points out, Congress appears to already have caved in on key aspects of apparent value. One wonders if CER can be the point of leverage for reform which White House Budget Director Philip Orzack thinks it can be. And if Orzack can't get what he wants out of CER, what might the integrative practice community extract from this big money battle in which maybe we can't, well, talk about money. In the other section, White explores the potential value of CER for the integrative practice community. 

I am among those who excitedly greeted the $1.1-billion "comparative effectiveness research"(CER) initiative in Obama's economic stimulus plan as an excellent direction for getting a handle on a medical system in which a third to half of care is deemed wasteful, and much of that harmful, according to our own Institute of Medicine. (See From Waste to Value in Health Care, JAMA, February 2008.) Not a moment too soon for the system, it would seem, and an excellent opening for integrative practice, particularly given the key backing by friends of integrative care.

Integrator contributor journalist, Daphne White does an excellent job of analyzing why this $1.1-billion piece of the Obama stimulus package may never live up to its value for consumers and for policy makers, and may have been partially aborted at birth. This is a sobering look at one of the first battle grounds for healthcare reform, 2009. Blood, it would appear, has already been shed via restrictions placed, at the request of the wasteful industry, by members of Congress who were doing their bidding. White takes you behind what she calls the "Kabuki play" she witnessed at the first 'listening session" of the Federal Coordinating Council for Effectiveness Research. Written comments can be submitted to the Council until May 31, 2009.

Comparative Effectiveness "Listening Session": Research, Politics, Evidence and Money

What happens when you mix together science, politics and $1.1 billion in government money?

When the issue is comparative effectiveness research (CER), the resulting brew is a Health & Human Services “listening session,” with 40 lobbyists, industry reps and advocacy groups each granted three minutes to speak. What you get is a three-hour-long Kabuki play: it’s long, it’s repetitive and it’s tedious.  And you sit there feeling that even though these people are speaking in plain English, what is coming out of their mouths is not even remotely connected to that thought bubble floating above their head.

Before we look at the action, let us review the back story, as explained first by Julie Rovner of National Public Radio. “That $2 trillion we spend on health care every year, every penny of that is someone’s income,” she told an audience at the Institute of Medicine last December, not mincing any words.  “The dirtiest word in health reform [is] not rationing … [it’s] redistribution.  Every time you take one of those dollars and give it to someone else, the donor is going to yelp and hire a lobbyist.” (ED: The text of Ms. Rovner’s statement may be found here.)

There were lots of lobbyists at the listening session, which was held at the Hubert Humphrey HHS building, right down the hill from the US Capitol.  Every player in the current system understands the potential harm that could come from comparative effectiveness research.  OMB director Peter Orszag has said the U.S. could save “$700 billion a year without harming health outcomes if we could just get the more efficient practices in some parts of the country into the less efficient rest of the country.” No one wants to be on the losing end of this equation.

In fact, the Wall Street Journal had reported on Feb. 9 that “the drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.”  A coalition of companies has already hired Babour Griffith Rogers -- “a public-relations firm that is part of one of Washington’s most influential lobby shops,” according to the Journal -- to represent their interests.  And Republican Senator Jon Kyl of Arizona had already tried to push a measure that would bar federal health programs from using comparative-effectiveness research to deny coverage.  The amendment was defeated, but it did manage to garner 44 votes – including those of key health care reform players Sens. Charles Grassley (R, IO) and Russ Feingold (D, WI).

“It’s hard to understand how reasonable people could oppose conducting the sort of research that aims to collect data so that we can actually know if one drug or medical device works better than another at fixing the same medical problem,” Michelle Andrews wrote in the April 17 edition of the U.S. News & World Report. “But the relatively paltry $1.1 billion” for CER “has created a firestorm of controversy, with conservative commentators and some providers raising the specter of regulation-happy government bureaucrats intruding into medical decisions that should be left to patients and their doctors.”

So you would think that when the drug purveyors and device-makers and surgeons from “less efficient parts of the country” got in the same room as “regulation-happy government bureaucrats” there would be fireworks.  There would be spirited debate and intense questioning.  Nothing could be further from the truth.  This was probably the most under-charged hearing I’ve ever covered.  The 15 members of the newly-minted “Federal Coordinating Council for Comparative Effectiveness” sat at a U-shaped table and listened impassively to each “panel” of presenters. The panelists were brought up 10 at a time to sit at a long table facing the “happy government bureaucrats.”  Some spoke at warp speed to cram as many words as possible into their three minutes, yet their affect was mostly flat.  They leaned heavily on words such as “transparency” and “process” and wouldn’t go near the words which populated the thought bubbles above their heads:  words such as “cost” and “cutting” and “self-interest.”

What was going on here?  This hearing was about as transparent as poker.  I decided to call an acquaintance that was also at the hearing, and works for one of the affected health care industries.  As soon as I assured him of total confidentiality, he was happy to explain the Kabuki dance.  “When government gets involved in anything, it changes the playing field and brings a different type of weight to the issue,” he said.  “When done correctly, CER takes a great deal of time and money.  Once the research is done, the temptation will be to turn it into a cost-savings thing, such as Orszag is talking about.  Instead of this industry growing at 10 percent a year – as it has been – it will just grow like the CPI. Nobody wants to get in front of the government and say you’re nuts, you can’t do this!  You’ve got to be a bit more thoughtful.”

As this acquaintance talked, I could feel the energy and passion in his voice.  His words and his thoughts were in sync:  this was the full monty.  That is why Congress – that most political of entities – wrote their report language to specifically state that this research money (a $1.1 billion investment of taxpayer dollars) was not to be used to compare or even consider the cost effectiveness of treatments, or to curtail coverage of less-effective (or even ineffective) treatments.

It takes a lot of energy to pretend that you don’t see the elephant sitting in the room:  it was all that self-restraint that kept the atmosphere so sedated.  One of the few people who actually was able to speak his mind was Steven Findlay of Consumers Union.  “It’s interesting that this process is about evidence in science, yet the process itself is more politics than science,” he told me afterward.  “The session was a little strange:  a lot of organizations are reluctant to press their case in plain terms.”

The meeting itself was transparent, yes, but that meant that a lot of competing organizations were in the room, and no one wanted to show their real hand.  “No one is going to just come out and say, ‘I’m Joe Schmoe from Pharma and please don’t do anything in this area that jeopardizes my profits’,” Findlay told me.  “The people on the Commission know what these groups think, and where they are coming from, particularly the industry groups.  The message is:  don’t mess with our cheese!”

Of course if no one moves the cheese, our health care system will remain exactly as it is right now.  So a few people – including Findlay – actually did make some suggestions about the cheese.  Findlay urged the panel to “consider steps that would make the CER program – over time – essentially free of conflicts of interest” in biomedical research and publishing.  “As a start, [the panel] should strongly favor researchers and institutions that are devoted to doing this research in the public interest and who have no current conflicts.”

After all, Findlay said, CER was created because “so much industry-funded research fails to adequately answer the critical questions that can help doctors and patients make treatment decisions.”  Acknowledging that a “conflict-free zone for CER” will take time, Findlay suggested that as an opening move the Commission could require, from the outset, “100% disclosure and transparency of all conflicts from both researchers and institutions.”

Like a number of other speakers, Findlay also stressed the issue of disparity in health care:  “CER simply must be mobilized to improve the health outcomes of various racial and ethnic populations and – over time – end the shameful gap that exists between the health status of some minority populations and other Americans.”

It became kind of a running joke that each speaker had three points to make in their three minutes, and Findlay’s third point was also made by several others:  he asked the FCC to make “a substantial effort to include consumers and patients in CER planning and implementation.  … Researchers and doctors tend to see the outcome of some treatments one way, and patients see it another way.”

The other speaker who made me sit up and listen was Winifred Hayes, president and CEO of Hayes, Inc. In answer to a question from one of the FCC panelists, Hayes said what everyone else was studiously avoiding:  “Cost effectiveness is the elephant in the room but at some point we have to address it.”  She added that we already have a lot of solid evidence related to effectiveness, “but that evidence is frequently not used.  I’d say that 20 -30 percent of the money should be used for dissemination, otherwise this would be a waste of time.”

In her testimony, Hayes noted that one of the reasons our health care system lags those of other developed nations is our “failure to effectively and efficiently integrate scientific evidence into healthcare decision-making and clinical practice, resulting in overuse, misuse and even (in some instances) underuse of health technologies.”  She also blamed “perverse financial incentives that drive premature dissemination of new medical technologies even when they do not improve patient care or outcomes” and “insufficient focus and allocation of resources to health promotion and disease prevention.”

In fact, wellness and disease prevention – the bread and butter of CAM therapies – were hardly mentioned in the three hours of testimony.  Of the 40 presenters at the “listening session,” there were no official representatives from CAM modalities or the integrative health care world.  It is possible that they tried to speak: only 30 speakers were selected from over 100 groups who requested a hearing.  However, the panel did open up 10 spots on the day of the listening session, and people could sign up on the spot.  Thirteen people signed up, 10 were selected.  Out of sheer frustration with the lack of CAM representation, I ended up putting my name on the list and my name was actually selected.  You can read my comments to the panel here.

There will be two additional listening sessions – one in the Midwest, one in Washington.  As it is written:  if you don’t play, you can’t win.  You can also submit written comments at CoordinatingCouncil@hhs.gov until May 30, 2009. 

Note: White's linked article on this topic, focusing on the CAM and integrative practice community, is located here.

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It became kind of a running joke that each speaker had three points to make in their three minutes, and Findlay’s third point was also made by several others: he asked the FCC to make “a substantial effort to include consumers and patients in CER planning and implementation. … Researchers and doctors tend to see the outcome of some treatments one way, and patients see it another way.”

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