Public Input Sought on Priorities for Comparative Effectiveness Research
By Rachel Walden — March 24, 2009
As part of the money for comparative effectiveness research included in the stimulus bill, the Institute of Medicine is required to submit a consensus report by the end of June that provides specific recommendations to Congress and the Secretary for prioritizing the expenditure of the funds. They are also required to solicit public input on these research priorities, and so have created an online survey to gather feedback from “all stakeholders in health care (e.g., patients, consumers, providers, state and federal agencies, employers, manufacturers, policy makers).”
Despite this stated purpose to gather input from patients and consumers, among others, the survey isn’t the most consumer-friendly thing in the world. In fact, the instructions begin with this somewhat intimidating language:
In the next 3 pages, you will have the opportunity to submit up to 3 comparative effectiveness studies for the committee’s consideration. Please rank your suggested CER priorities as first, second, and third by entering them in that order.
Once you have submitted your top 3 priorities, you will be asked what criteria you feel are most important in establishing a national set of priorities for CER. You will be asked to select and rank criteria (e.g. disease burden, disease severity, variation in care, cost, public interest, information gap) as well as identify other criteria for the committee to consider.
Lastly, you will be asked to provide recommendations to the committee regarding what new or enhanced capacities and infrastructure are needed to sustain a national CER enterprise.
Yikes. Similarly, when asking what research topic is of interest to the survey respondent, the following is used as an example: “Compare the effectiveness of identifying pre-malignant lesions and early colon cancer by either virtual or actual colonoscopy in individuals at low to moderate risk of colon cancer.”
While seeking input from the public on health research priorities is a good thing, it’s difficult to appreciate fully while knowing that the survey instrument is not really well-designed to collect feedback from the general public.
However, if you have an area of research you would like to recommend, you should consider submitting your feedback — you’ll just need to know what medical interventions you think should be compared, comment on why you think it is important, and make some selections about the subject area the research falls into, what area the interventions fall into (such as prevention, behavioral or drug treatment, surgery, etc.), and whether any specific population is of interest for the topic (such as women).
Many of the more detailed questions (such as the most appropriate type of study) are optional, so you don’t have to include any information other than what you think should be compared and why. You can make up to three suggestions via the survey.
Your suggestions are due by March 27, 2009.
A public meeting was also held March 20 in Washington, D.C., to hear from representatives from professional associations of health care providers, insurance and pharmaceutical industries, consumer advocacy groups, public health and government agencies, and other organizations.
As Christine mentioned in her most recent Political Diagnosis, the government has also named a 15-member expert panel to advise on research priorities, including representatives of AHRQ, the CDC, FDA, Department of Defense, and other agencies. For additional background, see our previous post on the stimulus bill money allocated for comparative effectiveness research.
Rachel: I am very worried that the proposed comparative effectiveness research will leave much to be desired. I fear that it will end up recommending more of the “same-old-same-old” treatments — but that the “same-old-same-old” treatments it recommends will just be of a less costly variety! On the flip side, I fear that some far less expensive, more effective treatments — whose only crime is that they do NOT have pharmaceutical ties and/or funding — will be totally omitted from the research.
Your February 25th posting, “Evidence-Based Medicine Gets a Nod in Stimulus Bill,” gave an excellent description of what the research is intended to do, and why it is important that such comparative effective research be done. In addition, you cited Alicia Mundy’s WSJ piece, which “suggested that drug and medical-device industries were ‘mobilizing to gut’ the comparative research provision.”
I wasn’t at all surprised to read that. Nor was I surprised to read in THIS posting that the instruments that have been created for consumer “input” are very UNuser-friendly.
This is very sad.
But, to me, equally sad — and, I think, a point that NO ONE has yet adequately addressed — is that several extremely effective, lifesaving, inexpensive treatments may be completely LEFT OUT of the comparative effectiveness research mix. Why? Because they are treatments that are NOT manufactured by pharmaceutical companies.
I am referring here to two kinds of treatments: (a) “alternative” treatments; and (b) lots of other “science-based” treatments that are, unfortunately, often unfairly called “anecdotal.” These treatments are called “anecdotal” for only one reason: because they haven’t gone through the billion+ dollar double-blind randomized clinical trials. (Most of these “trials,” of course, are conducted and paid for by Big Pharma.)
I have interviewed pioneers in the successful use of several of these science-based, though so-called-“anecdotal” treatments on my website, HonestMedicine.com. The specific treatments I have written about so far are: LOW DOSE NALTREXONE for autoimmune diseases, such as multiple sclerosis; the KETOGENIC DIET for pediatric epilepsy; and INTRAVENOUS ALPHA LIPOIC ACID, for diabetic neuropathy and organ regeneration. Each of these three treatments has been helping thousands of people with very serious, often life-threatening conditions for OVER THIRTY YEARS. (You may read about them at http://tinyurl.com/cspj99 .)
Why, then, don’t I think that these treatments (and others like them) will be included in the comparative effectiveness research?
For proof that my suspicions are well-founded, all you have to do is go to http://tinyurl.com/bfc6wg, for a video of the recent Senate Hearings on Integrative Medicine and the new health plan, where Drs. Mehmet Oz, Mark Hyman, Andrew Weil and Dean Ornish testified.
There, you will find the following interchange between Dr. Mark Hyman and Sen. Tom Harkin (at 142:00 to 142:36) :
DR. HYMAN: (re the Comparative Effectiveness Research that will be done to determine which treatments work best for patients): “What are we comparing things TO? Drug to drug? Procedure to procedure? Or are we comparing the current medical practice with the best available things we’re talking about [e.g., integrative treatments]?”
SEN. HARKIN: “I’m afraid — I share your fear — that it’s going to be a comparative analysis between this treatment and that treatment.”
DR. HYMAN: “Within the allopathic model.”
And by the way, without stating it, when he refers to the “allopathic model,” Dr. Hyman is, of course, referring to the PHARMACEUTICAL COMPANY MODEL. It’s the only model the American Medical System acknowledges.
To listen to my interview with Dr. Burt Berkson (MD, PhD), pioneer since the 1970s of the use of Intravenous Alpha Lipoic Acid, please go to http://tinyurl.com/cgfjh3 . In it, Dr. Berkson speaks eloquently about how our medical education system teaches doctors NOT to be curious about more innovative, less expensive treatments — such as the three I have written about, both here and on my website.
I wish us ALL the best of luck with our new healthcare system. I strongly believe that all of us who know better must work really hard to get the word out to the healthcare decisionmakers in Washington, D.C.
Can the people at Ourbodiesourblog.org help? I know lots of people who would join in!
Julia Schopick
http://www.HonestMedicine.com
Julia, I think you make some good points about how there could potentially be a problematic focus on drug treatments rather than non-drug options. I noticed that in the NIH’s challenge grants for CER, they do specifically mention some non-drug and CAM topics they’d like to see studied. I would encourage you, though, to complete the IOM survey (as un-friendly as it is) and give them the examples you’ve given us. While some of the comparative effectiveness research dollars will go to systematic reviews that will evaluate the existing evidence on various therapies, some of the dollars appear to be designated for new research as well. I also found an email address – CERPriorities@nas.edu – for the IOM comparative effectiveness priorities team, and I think you (and others with similar concerns) should definitely send them along. Just my two cents!