I thank everyone for my warm welcome to the SBM community. Although vaccine myth is of particular interest to me, I promise that my posts wont all be vaccine related. There is, unfortunately, much to discuss. In fact I had a difficult time deciding which vaccine-related issue to write about for my inaugural post. In the end I came up with more of an opinion piece, but it’s an issue worth airing. Things in anti-vaccine land may be reaching a dangerous turning point.
Archive for Public Health
Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the “Summit on Integrative Medicine and the Health of the Public” convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.
Senator Harkin and the Scientific Method
Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):
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)
Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—“seeking out and approving”—is incoherent.
The Selling of ‘Integrative Medicine': Snyderman Trumps Weil
Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:
There are many ways in which cult medicine believers try to insinuate themselves into the health care system. As Dr. Gorski has pointed out, “prevention” is one of their metaphorical feet in the door. The cult medicine literature often says things like, “mainstream medicine is fine for treating acute illness, but what we do is prevention.” What they often leave out is the question of what “prevention” means, what the data on prevention is, and how to properly approach prevention. It’s likely that one of my co-editors will touch on this topic in a bit more detail, but let me give you an introduction to the topic of prevention.
Prevention is usually divided into three types: primary, secondary, and tertiary.
Primary prevention refers to the prevention of diseases and conditions before their biological onset. Examples of our most successful primary prevention interventions are clean water/sewerage and, ironically, vaccination. I say “ironically” of course because so many of the altmed folks who talk about prevention are anti-vaccine.
Secondary prevention refers to the search for diseases that have not yet progressed to the point of causing overt disease, and intervening to prevent overt disease. This includes things like Pap smears, which look for early cervical cancers (which could have been primarily prevented by vaccination), mammography, which looks for early breast tumors, and colonoscopy, which looks for early colonic neoplasms. Secondary prevention is sometimes used synonymously with “screening”.
Tertiary prevention refers to the prevention of progression of and complications from existing disease. For example, retinal and foot exams in diabetics prevent blindness and amputation very effectively.
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.
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:
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.
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.
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:
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…”
“A person is smart. People are stupid.”
– Agent K (Tommy Lee Jones), Men In Black
Regular readers of my blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.
Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of them to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.
There is growing support in the consumer-driven healthcare movement for a phenomenon known as “the wisdom of crowds.” The idea is that the collective input of a large number of consumers can be a driving force for change – and is a powerful avenue for the advancement of science. It was further suggested (in a recent lecture on Health 2.0), that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild: