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Does NCCAM's"Priority Setting Framework" Focus on "Products"? Response from Director Briggs PDF Print E-mail
Written by John Weeks   
Tuesday, 27 April 2010

Does NCCAM's"Priority Setting Framework" for 2011-2015 Focus on Researching "Products"? A Message and Clarification from Dr. Briggs

Summary: The recently published "priority-setting framework" for the 2011-2015 NIH NCCAM strategic plan left the strong impression that the agency had merged with the Office of Dietary Supplements. The short statement in a April 16, 2010 "Message from the Director" by Josephine Briggs, MD focused on investigating "products." The term denotes the field of integrative practice 3 times in the short guide. Adding to this apparent pigeon-holing are repeated highlights of basic science questions and efficacy trials and the absence of any allusion to outcomes research or whole disciplines. In short, the published framework appears more appropriate for exploring conventional pharmaceuticals than multi-modality, whole person approaches. I contacted Briggs with some pointed questions, referencing NCCAM's Congressional mandate. Here is Briggs' NCCAM framework, my questions, and her letter in response.
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for inclusion in a future Integrator.

Related Integrator articles in this series:


Image
Vitamins, herbs, supplements: Priorities for NCCAM in 2011-2015?
In an April 2010 Message from the Director, Josephine Briggs, MD, director of the NIH National Center for Complementary and Alternative Medicine (NCCAM) offers "a priority-setting framework to help determine which research directions to pursue" in the 2011-2015 strategic plan. (Bold is added.)
_____________________________

NCCAM's "Priority-Setting Framework"
for the 2011-2015 Strategic Plan


[As published in this Message from the Director.]

  • "Science: Is there clear scientific opportunity in studying this product? Are there methods and technologies available that permit rigorous studies to clarify biological mechanism and ultimately clinical efficacy?

  • "Promise: Is there a body of evidence indicating that the product has the potential to contribute to treat troublesome or prevalent health conditions or symptoms? Or is there evidence it acts on a biological pathway of importance in health and disease?

  • "Use: Is the natural product in widespread use? Does the research address a public health concern regarding efficacy, safety, or lack thereof?

  • "Impact: Will the research have scientific or public impact?"
_____________________________

Image
Does the agency's 1998 Congressional mandate fit in its 2010 priority framework?
The choice of words in this framework were startling if not dismaying for those who think NCCAM would best serve the public by charting a course that more closely reflects actual integrative practices.


Repeated in this document is reference to the evaluation of "products."
Integrative practitioners, who may use natural products in their practices, don't describe what they do in "product" language. Nor are mind-body interventions typically described as "products," unless perhaps one is referencing CDs or DVDs. Acupuncturists do not view themselves as "products," even if they merely needle.

   
 This is not quibbling over semantics.
The language from the Director
project the NIH's pharmaceutical bias
over the holistic, whole person
integrative practice landscape.

 
Notably, when Congress established NCCAM in 1998, the focus was not on products. Rather, Congress created NCCAM to examine "complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems." This phrase, or an analog, was used 6 times in the short mandate. The word "product" does not appear. Nor do the terms "herbs" or "vitamins" or "supplements" or "natural products." 

This is not quibbling over semantics. The language from Briggs projects NIH's pharmaceutical bias over the holistic, whole person integrative practice research landscape. This reiteration of the reductive agenda which defined the first decade of NCCAM's mechanism and natural drug-trial priorities is underscored by the two references each to mechanism and to efficacy trials.


Does this language, consciously or unconsciously, capture the thinking inside NCCAM as the 2011-2015 strategic plan is near completion? If so, NCCAM appears to be taking a huge step backward from the
new "effectiveness" direction and emerging interest in "real world outcomes" about which Briggs' has spoken. I summarized my concerns in a April 26, 2010 electronic message to Briggs. (See bottom of this article for my full query.) Here is Briggs' response.

_____________________________

Response of NCCAM's Briggs on Questions
on the "Products" Focus in the Priority Setting Framework

[Received by e-mail, April 27, 2010]

Image
Briggs: Clarifying misleading language
"Thank you for your note and for reading the message so carefully. Indeed, it is not our intention to only study products, but more broadly to encourage research on CAM practices, disciplines, and whole systems- as well as products. The language suggesting a focus on natural products was quite inadvertent; in fact, there are many important CAM interventions that would not be labeled as products.


"The larger message I was trying to convey is that, through our strategic planning process and extensive community input, we are developing a framework by which to prioritize our research in a methodical and systematic way. As you know, there are many different perspectives about where NCCAM should focus our research efforts, and having such a framework ensures that we continue to be neutral and objective in our approach.

   
"The language suggesting a focus on
natural products was quite inadvertent;
in fact, there are many important CAM
interventions that would not
be labeled as products."

 
"NCCAM recognizes the unique and important roles for basic, clinical, as well as outcome (real world effectiveness) research. While natural product research may need to focus more on mechanistic research, mind-body interventions may need more focus on outcome research.

"This type of dialogue helps us to hone our strategic thinking and how we communicate to our stakeholders.

"I want to assure that your input is a highly valued component of our strategic planning process, and your careful reading is helpful in avoiding potential unintended implications.

"We thank you for it.

"Appreciatively"


Josephine P. Briggs M.D
Director, NCCAM
National Institutes of Health
_____________________________

Comment: First, I thank Briggs for her prompt response. She continues her pattern of communicating with NCCAM's remarkably diverse set of stakeholders, on which I commented recently. I am sure that my queries are not always the most pleasant part of her day. No doubt her life is full of pushes and pulls from many corners. It is an honor to be considered a a valued participant in this important dialogue.

   
  How differently this "priority-setting
framework"
would have read had Briggs
merely appropriated and internalized
the language Congress gave NCCAM
for prioritizing its agenda. 


Yet while Briggs' clarification is pleasing, it fails to expunge my concern. Slips of language are meaningful. Freud said that. I would guess that such slips as these would be far more likely in a researcher, like Briggs, who joins the field without prior connection with "CAM" or integrative medicine. "Products" is the native language of her home country. It's her comfort language, just as "whole practices" and "treating the whole person" and "holistic" are my own, having lived inside them for nearly 3 decades.

While there is no doubt that Briggs has quite laudably met with practitioners of all kinds during the 27 months of her entry into the field, this slip makes me wonder how deeply new thinking has penetrated. Has she taken a Berlitz course or realized that her great success must be via immersion into new cultures and disciplines?

I would not continue to hold my concern in reserve had the original framework in any way acknowledged all that it omitted. Read it once for its exclusions. Happily, Briggs alludes to outcomes and disciplines and real world research and whole systems in her response. But she needs to trumpet this new agenda. Her signature strategic plan needs to be remedial. Under her predecessor, NCCAM liked "products," basic research and efficacy trials to the
near exclusion of outcomes. And we left that era with many wondering about the value of the Center.

How differently this "priority-setting framework" would have read had Briggs merely appropriated and internalized the language Congress gave NCCAM for prioritizing its agenda. The bold is the language of Congress.

  • Science: Is there clear scientific opportunity in studying this complementary and alternative treatment, diagnostic and prevention modality, discipline or systems?

  • Promise: Is there a body of evidence indicating that the complementary and alternative treatment, diagnostic and prevention modality, discipline or systems have the potential to contribute to treat troublesome or prevalent health conditions or symptoms?
 
  • Use: Is the complementary and alternative treatment, diagnostic and prevention modality, discipline or systems in widespread use?
 .
   
At this late moment,
this triple slip-of-the-tongue
remains deeply troubling.
 
 
As we move precipitously close to the unveiling of NCCAM's draft strategic plan, scheduled for release in June 2010, we need declarations that a significant share of NCCAM's resources will target real world questions. "Balance" in investment, as urged by Consortium of Academic Health Centers for Integrative Medicine, would suggest $35-$45-million each year of NCCAM's $120-million. So far we have little evidence that NCCAM is contemplating anything close to that.

This is hard. Briggs may be the best leader NCCAM could have in this moment, all things considered. She has won the respect and support of many. Yet at this late moment, this triple slip-of-the-tongue remains deeply troubling.


________________________________

Weeks' Query Letter to NCCAM Director Briggs

[Sent April 26, 2010.]

"I have questions regarding the message from the director. In the priority setting framework you reference studying "product"

"...  As we develop our next strategic plan, we've created a priority-setting framework to help determine which research directions to pursue:

  • Science: Is there clear scientific opportunity in studying this product? Are there methods and technologies available that permit rigorous studies to clarify biological mechanism and ultimately clinical efficacy?
  • Promise: Is there a body of evidence indicating that the product has the potential to contribute to treat troublesome or prevalent health conditions or symptoms? Or is there evidence it acts on a biological pathway of importance in health and disease?
  • Use: Is the natural product in widespread use? Does the research address a public health concern regarding efficacy, safety, or lack thereof?
  • Impact: Will the research have scientific or public impact?

My questions are:

1. "Product" is typically meant to be a thing that a practitioner uses as an agent, as in "natural product" - herb or supplement or drug. Is this what you are indicating here? If not, why this language?

2. In the NCCAM mandate which you reference in your white papers on the strategic plan, there is no reference to studying "products." Rather, Congress repeatedly focuses the Center on investigating "alternative treatment, diagnostic and prevention modalities, disciplines and systems." How are researchers and stakeholders to reconcile the language in the framework with this mandate?  What reason would they have to feel that NCCAM is interested in "diagnostic and prevention modalities, disciplines and systems"?

3. In the NCCAM mandate, basic research is in a list as #4 of 6 types of research, and RCTs/efficacy trials as #5.  These follow outcomes #1 and health services research #3. The "science" portion of the framework directly references basic research (mechanism) and RCTs (efficacy trials) only. How is this reconciled with the focus of the mandate? How are those who are interested in studying outcomes of interventions via "disciplines and systems" to feel that this includes them?

4. Again, under the "promise" portion of the framework, the focus is on basic research ("biological pathways"). How again are those interested in exploring outcomes from examining disciplines and systems and preventive approaches.

5. Again, the "use" portion also focuses on efficacy trials. Is this an indication that NCCAM will continue to elevate RCTs above outcomes in the 2011-2015 plan?

My questions are not only about the inclusion of "product" language and focus on basic and efficacy research around which the framework is built. It is also about exclusion in your chosen language of other ways of research. For instance, might you have used this language to describe the framework:

  • Science: Is there clear scientific opportunity in studying this complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems? Are there methods and technologies available that permit rigorous studies to clarify biological mechanism and ultimately clinical efficacy?

  • Promise: Is there a body of evidence indicating that the complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems has the potential to contribute to treat troublesome or prevalent health conditions or symptoms? Or is there evidence it acts on a biological pathway of importance in health and disease?
 
  • Use: Is the complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems in widespread use? Does the research address a public health concern regarding efficacy, safety, or lack thereof?

Thank you for your time, and clarity.  I am sure the many provider stakeholder organizations that have urged NCCAM to explore real world outcomes and research on whole practices will be interested in your response.

I plan to publish this April 29 - at the latest May 3, and so would appreciate a response as soon as possible. Thank you.

John

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three times and focus on basic research and efficacy studies:
Last Updated ( Wednesday, 28 April 2010 )
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