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Double Standards – Newsweek and Tom Harkin

There has been a flurry of news relevant to science-based medicine in the last week – more than enough to keep a bevy of bloggers busy. More important than the individual news items themselves is the striking pattern they bring into focus when viewed together – the growing and pernicious double-standard between mainstream medicine and so-called CAM.

Begley vs Doctors

Science editor Sharon Begley wrote an interesting piece in Newsweek with the provocative title: Why Doctors Hate Science.  I was not particularly impressed with the article – it took a rather narrow approach to a complex problem and ran with it. She writes:

It’s hard not to scream when you see how many physicians, pharmaceutical companies, medical-device makers and, lately, hysterical conservatives seem to hate science, or at best ignore it. These days the science that inspires fear and loathing is “comparative-effectiveness research” (CER), which is receiving $1 billion under the stimulus bill President Obama signed. CER means studies to determine which treatments, including drugs, are more medically and cost-effective for a given ailment than others.

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Tom Harkin’s War on Science (or, “meet the new boss…”)

This was cross-posted at White Coat Underground, despite the topic having been covered by Dr. Gorski yesterday. The topic is important enough that many of us in the medical blogosphere are going to be talking about this.

Remember when President Obama said something about returning science to it’s rightful place? Well, our new president has a real tough climb ahead of him. The previous administration shoved science aside for political expediency and religious ideology. Now, forces in the president’s own party are trying to insert their own quasi-religious beliefs into health care reform, leaving science in a whole different place altogether.

Here’s the deal. Some years back, Senator Tom Harkin (D-IA) helped set up the National Center on Complementary and Alternative Medicine (NCCAM). The whole idea of setting up such an agency is a bit quixotic—after all, the National Institutes of Health already study health science. As my colleagues and I have written many times before, the very idea of the agency seems ridiculous. Many, many studies have been funded which fail basic tests of plausibility and ethical propriety. Also, a huge percentage of the studies funded fail to ever publish their results. Still, some studies have been published, and more often than not, they find that the “alternative” modality being studied fails to behave better than placebo. That’s probably the sole redeeming quality of the agency, but not enough to keep it open, as these studies could have been done under the auspices of the NIH.

It turns out that Senator Harkin agrees with me on one point: NCCAM is failing to validate many alternative modalities. The difference is that I find it heartening and Harkin finds it disturbing:

“One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.”(from last week’s hearings, time marker approx. 17:20)

Well, at least he’s honest. He comes right out and bemoans the fact that science hasn’t upheld his quasi-religious medical beliefs. He just doesn’t get it. If you choose to investigate a scientific question, you have to be prepared for “bad news”. You don’t get to decide the outcome before the fact.

But Harkin makes his goals very clear, from his prepared statement, to the “experts” from whom he took testimony.
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Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

Senator Tom Harkin (D-Iowa) owes me a new irony meter.

I’ll explain in a minute, but first you have to know why I even care about what Harkin says or does, given that he’s not my Senator. As you may recall, arguably no single legislator in the U.S. has done more to harm to the cause of promoting science- and evidence-based medicine than Tom Harkin. That’s because it was primarily through Harkin’s efforts that the National Institutes of Health, despite the fact that its scientists were not agitating for it, had the National Center for Complementary and Alternative Medicine (NCCAM) rammed down its throat in 1992, first as the Office of Alternative Medicine (OAM), then in 1998, when NIH Director Harold Varmus tried to place OAM under more scientific NIH control, by elevating OAM to a full and independent Center within the NIH. Thus was NCCAM born.

I’ve complained many times about how NCCAM funds studies that, let’s face it, are of pseudoscience and quackery (homeopathy, anyone?) and even more about how it promotes unscientific medical practices. I’ve argued time and time again that there is no research that is funded by NCCAM that couldn’t be dealt with as well or better by other Centers or Institutes within the NIH. I’ve even argued that NCCAM should be defunded and dismantled, allowing CAM grant applications to be evaluated by the most appropriate center, as has our fearless leader Steve Novella. Most vociferous of all has been my fellow SBM blogger Kimball Atwood, who has made similar arguments at even greater length. I’ve also pointed out Harkin and other CAM-friendly legislators created and managed to increase the funding of NCCAM to the tune of $120+ million a year not for the purpose of rigorous scientific evaluation of CAM practices, but rather to promote CAM and ultimately “integrate” it with scientific medicine. At this they have been enormously successful.

Let me clarify. What I meant is that NCCAM, along with the Bravewell Collaborative, has been very successful in popularizing CAM in medical academia; at “proving” that CAM works, not so much. Evidence that this is so comes from a recent observation that Senator Tom Harkin is very, very unhappy with NCCAM these days and has publicly said so recently, as pointed out by Lindsay Beyerstein, daughter of the late, great skeptical psychologist Barry Beyerstein. On Thursday, Harkin told a Senate panel, Integrative Care: A Pathway to a Healthier Nation, that he was disappointed that NCCAM had disproven too many alternative therapies. (His remarks begin about 17 minutes into the video on the webpage to which I linked.) In addition, Harkin’s statements have also been posted to his Senate blog:
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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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2009: Shaping up to be a really bad year for antivaccinationists

I will begin this post with a bit of an explanation. Between one and two weeks ago, there appeared two momentous news about the manufactroversy regarding vaccines and autism. No doubt, many SBM readers were expecting that I, as the resident maven of this particular bit of pseudoscience, would have been here last week to give you, our readers, the skinny on all of this. Unfortunately, as some know, my wife’s mother died, coincidentally enough, on the 200th anniversary of Darwin’s birthday and a day when one of those two momentous bits of news was released to the public, which is why I used one of my handful of posts written and then held in reserve. I’m back now, though, and I don’t think it’s too late to comment on these bits of news because now that over a week has gone by what I’ve seen has led me to draw some conclusions that I might not have been able to do, had I done my usual bit and been first off the mark (at least among SBM bloggers) discussing the story.

2008: The Best of Years for the Antivaccine Movement

But first, let’s take a look at last year. In 2008, Jenny McCarthy was the new and fresh celebrity face of the movement that believes that autism and all manner of other neurodevelopmental disorders are caused by vaccines and that the government and big pharma are suppressing The Truth. She had emerged in the fall of 2007 after having tried to erase from the Internet her previous involvement in the “Indigo Child” movement in preparation for becoming an “autism advocate” who could write a book that could land her on Oprah’s show. Thanks to her and, perhaps even more so to the star power of her boyfriend Jim Carrey, who is just as wrong about vaccines and medicine as Jenny is, the antivaccine movement came roaring into prominence in a way that it had never managed to pull off before. After all, let’s face it, a former Playboy Playmate of the Year and a famous comedian are far more “interesting” public figures for various media outlets to interview than previous celebrities who spearheaded the vaccine manufactroversy, such as Robert F. Kennedy, Jr. or Don Imus and his wife Deirdre.

Indeed, Jenny’s combination of good looks and utter obnoxiousness led to her showing up all over the media in 2008. For example, on April 1 (appropriately enough), she appeared on Larry King Live! and shouted down physicians who had the temerity to tell her that her Google University knowledge was just plain wrong. The pinnacle of her influence came during the summer, when, having now supplanted J.B. Handley as the public face of the antivaccine group Generation Rescue and transforming GR into “Jenny McCarthy’s autism charity,” she led the “Green Our Vaccines” rally in Washington, DC. True, at most there were several hundred people there, but it got wide news attention, and Jenny was all over the news. She rapidly followed it up by releasing a second book Mother Warriors: A Nation of Parents Healing Autism Against All Odds and appearing on The Oprah Winfrey Show yet again.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

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Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society

This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse ”NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.

To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary:

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Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation, Public Health, Science and Medicine

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Comparative Clinical Effectiveness Research: Good News In Shades Of Gray

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation, Public Health

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Obama and Stem Cells

In 2001 George Bush signed an executive order banning federal funding for embryonic stem cell research, except for those lines that were already established. As a result such research ground to a halt in the US.

While the order was presented as a compromise, the effect was chilling in its application. No researcher receiving federal dollars (even for a separate project) could do embryonic stem cell research, except on the approved lines.  Institutions could not risk losing federal grants and so had to purge themselves of any banned research. The approved lines did not turn out to be as useful as was originally claims, and they became progressively obsolete as new techniques were being developed through state and private funding.

It is impossible to measure the effect that Bush’s ban had on ultimate scientific progress in this area. It is not just that we lost eight years – expertise in a cutting-edge scientific area can be a tenuous cultural and institutional thread, once broken it is difficult to recreate.

We will hopefully have a chance to find out. It was expected that one of the first measures of the Obama administration would be to lift the federal ban. In fact, I am a bit surprised it has not happened already. But it seems it soon will – insiders are saying that Obama plans to lift the ban soon.

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Posted in: Medical Ethics, Politics and Regulation

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More evidence that CAM/IM advocates see health care reform as an opportunity to claim legitimacy

Four weeks ago (was it really that long?), I wrote one of my usual lengthy essays for this blog in which I analyzed two editorials published by some very famous advocates of “complementary and alternative medicine” (CAM)/”integrative medicine” (IM). They included one in that credulous repository of all things antivaccine The Huffington Post (no, this isn’t about vaccines, but I can’t resist pointing out at every turn the antivaccine slant of that rather famous political blog) and in the Wall Street Journal. The first, published in HuffPo and written by Deepak Chopra, Andrew Weil, and Rustum Roy, was entitled Leaving the Sinking Ship, while the second added Dean Ornish to its team, switched from the highly liberal venue of hte previous article to the conservative WSJ, and was entitled “Alternative” Medicine Is Mainstream: The evidence is mounting that diet and lifestyle are the best cures for our worst afflictions. In doing so, advocates of unscientific and even pseudoscientific faith-based medical treatments seemingly covered the entire span of political thought, from highly liberal to highly conservative, with their message.

That message, as I have argued, along with Wally Sampson, Kimball Atwood, Val Jones, and Peter Lipson, is, to boil it down to its essence, this: The new Obama Administration has promised to make health care reform one of its top priorities, and CAM/IM advocates want to take advantage of this movement for reform as the “foot in the door” behind which they try to muscle their way in to be treated by the government as co-equal with established, science- and evidence-based medicine. How do they plan on doing this? As I have discussed before, they plan on doing this by coopting disease “prevention” strategies as being CAM/IM and using them as a Trojan horse. When the government brings the giant wooden horse into the fortress of government health care, along with the bona fide prevention strategies of diet and exercise a whole lot of woo will jump out of the belly of that horse and open the fortress doors to let in its comrades. Indeed, the same strategy can be seen in how CAM/IM advocates have coopted the Institute of Medicine with a joint conference.

In other words, because CAM/IM advocates have succeeded so well in tying the perfectly acceptable science- and evidence-based modalities of diet and exercise, as well as ghettoizing the respected pharmacology discipline of pharmacognosy by associating it with herbalism and, in essence, bringing it under the CAM umbrella, where it became unfairly and incorrectly tainted with its association with all the other woo that falls under the CAM/IM mantle, they expect that renewing an emphasis on diet and exercise by their definition and on their terms will lead to the opening of the door into the promised land of having their modalities be funded by the government. It’s a very conscious strategy, which is why Chopra et al’s articles so clearly tried to convince readers that diet and exercise are CAM/IM. Unfortunately, that they are able to do this with such success is in part because science- and evidence-based practitioners arguably underemphasize such health prevention strategies.

I learned of another salvo fired off by CAM/IM advocates through my somehow finding myself on the mailing list for The Mary Ann Liebert, Inc. family of medical journals. Unfortunately, one of the journals published by the Liebert group is the Journal of Alternative and Complementary Medicine. This particular e-mail was advertising an editorial written by a chiropractor named Daniel Redwood that spells out in the most detailed manner exactly how CAM/IM advocates plan on hijacking any health care reform that the Obama Administration might come up in order to persuade the government to fund what Wally frequently terms “sectarian medicine” and I simply like to call unscientific. The editorial is freely available to all (unlike the contents of JACM) and entitled Alternative and Complementary Medicine Should Have Role in New Era of Health Care Reform. It’s about as blatant a description of the goals of the CAM/IM movement as I have ever seen.
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Yes We Can! We Can Abolish the NCCAM! Part III

A Reminder…

…of why we keep harping on this. A couple of days ago The Scientist reported that the “economic stimulus package” may include a windfall for the NIH:

Senate OKs big NIH bump

Posted by Bob Grant

[Entry posted at 4th February 2009 04:12 PM GMT]

The US Senate, which is furiously debating the details of the economic stimulus package making its way through Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill…

Exactly how an NIH funding increase will be spent remains to be determined.

You can bet that if this happens, the NCCAM will be licking its chops for some of that lettuce. Let’s continue to explore why it shouldn’t get any…

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