Sherman Cohn: Report on the NIH NCCAM Advisory Committee Meeting, September 12, 2008

Summary: Sherman Cohn, JD attended the September 12, 2008 meeting of the NIH National Advisory Council on Complementary and Integrative Medicine and sent me a report. His notes refer to a discussion of challenges in CAM research, programs to support careers of distinctly licensed professionals, a historic look at botanicals in medicine, a concept paper on CAM for pain, data from a 2007 consumer survey and some future directions. I figured some of you would be as interested as I was. Cohn, a professor of law at Georgetown University since 1965, a leader in the emergence of the acupuncture profession since the early 1980s, and a sometimes contributor to the Integrator, gave me an okay to share the report with you. Enjoy.   

Sherman Cohn, JD - reporting the NCCAM meeting

Sherman Cohn, JD, a sometimes Integrator commentator, will be a featured presenter at the October 2008 conference of the American Association of Acupuncture and Oriental Medicine. His topic is that profession's history about which he knows a good deal as an actor and observer. Cohn chairs the board at Tai Sophia Institute and that of the National Acupuncture Foundation, was chair of the Accreditation Commission for Acupuncture and Oriental Medicine (1983-1994) and a member of the board of the Acupuncture and Oriental Medicine Alliance. He is also currently a director of the Integrated Healthcare Policy Consortium (IHPC). Cohn, a former Watergate lawyer (on the winning side) has been a member of the law faculty at Georgetown University since 1965. At Georgetown, he teaches a course on legal issues of alternative, complementary and integrative medicine and lectures in that subject at Georgetown Medical Center and Tai Sophia Institute.

I attended the National Advisory Committee of NCCAM on Friday. Here is a relatively short report  - as fast as I could take notes, in my own words un less otherwise indicated. Acoustics were also not very good for the public, at least, for us old folks. Where I make a comment, I try to be clear that is my pwn comment.

Searches for 2 key positions; NCCAM budget

Dr. Briggs announced that Richard Nahin, PhD, MPH, NCCAM's senior advisor for scientific coordination and outreach is also serving as the acting director of Extramural Research.   (Apparently Extramural Research means research outside of NCCAM, which NCCAM funds.)   A search is now underway for the Director. Dr. Briggs expects to have an appointment by end of the year.

There is also a search going on for Deputy Director of NCCAM. Included on the search committee are Janet Kahn, PhD, and Aviad Haramati, PhD (both researchers as well as IHPC leaders).

There is currently a review of the Intramural Research Program, which is currently quite small. The evaluation of this program is scheduled to be completed by January 2009. NCCAM has an Intramural Board of Scientific Counsellors.

Budget.  Fiscal year (FY) 2008 is $121,577. House and Senate committees have approved budgets of $125,878 and $125,082 respectively for FY 2009.

Programs for CAM practitioners and institutions

Osher Foundation is sponsoring career development grants for NCCAM. The program is open to CAM licensed practitioners with doctorates in their CAM fields (DC, ND, DAOM, some DOs). The program is not getting much response.  The eligibility definition will be expanded to CAM licensed practitioners with doctorates in any field, not necessary in a CAM field. 

In June, there was the first NCCAM Grantmanship Workshop. Over 200 applicants applied and 75 were chosen to participate. The workshop was presented as a great success.  Hopefully, this will increase applications for grants from CAM institutions.

In a discussion of improving the peer review of grant applications, a statement was made that there must be a greater attempt to encourage grant applications from "early stage investigators" and not just seasoned investigators. NCCAM is giving serious attention to that issue.

Growth in number of publications citing NCCAM support

The number of publications that cite NCCAM support increased in 2007 to 448.  There were 249 separate grants cited. 70 papers resulting from NCCAM grants were published in "high impact journals."  Dr. Briggs stated that the choice of which journals have "high impact" is subjective and generally limited to the well established journals. As one example, she cited a Journal of the American Medical Association article:  "Lead, Mercury & Arsenic in US and Indian-manufactured Ayarvedic Medicine Sold via the Internet." (8/27/08)

NCCAM held a "Summer Scientific Retreat" that examined "Case Studies in (a) Biological Portfolio," including Probiotics, Soy, Ginseng, Echinacea, and Glucosamine, as well as Case Studies for "specific indicia" including depresssion and irritable bowel symptoms.

CAM research and health and well-being

An issue addressed is the "increased evidence that CAM can intervene to promote health and well being, but it is not conclusive."  More research is needed to understand "more definitively the effectiveness of CAM to promote health and well being." 

There is particular need to do more research on CAM modalities that the public frequently uses to promote health and well being.  Specifically cited CAM modalities included mind-body medicine and acupuncture.  Dr. Briggs said that "we want to focus on seeing if there are benefits," adding that "We need to solicit applications, probably of RO-1 grants for this purpose."

A discussion of challenges in CAM grants

Josephine Briggs, MD, NCCAM director

There was discussion of CAM grants.  The following statements were made:

-- The real problem is capturing the results.  How does one determine that the "subject" actually does what he or she is supposed to do at home, e.g., meditation?  And what is the quality of that meditation and how do we measure it?   How do we capture the result of that meditation, whatever its quality.
--  A CAM practitioner of one modality does not know how to deliver other CAM modalities, e.g., an acupuncturist does not always know how to teach meditation. 
--  Dr. Briggs stated that in the studies that have been done to date, there is lack of clarity of intervention.  She believes NCCAM can help remedy the short-coming, but it is up to each discipline to learn how to define what they are doing. She states that there must be standardized protocols of what goes on in the intervention. This is particularly important when a study is done in a multi-site trial. Each site must do the same thing. So far, the CAM community is not ready for such trials. We must find the way to help the CAM community learn how to do it.

Presentation: Botanicals, Past, Present & Future

Stephen Barnes, PhD of University of Alabama (Birmingham) and a NCCAM member gave a presentation on "Botanicals, Past, Present & Future."

	Captain Cook forced his men to eat fresh food on these ships, thus preventing scurvy. This is the first example of preventive medicine we know of.

Past:   Early humans had a long history of exposure to plant-derived phylochemicals. They detected those with robust, metabolism to de-toxify and eliminate poisonous compounds in the body.  Many of these were psychoactive; others were medicinal; either way, they gave the "leaders" of the time the opportunities to demonstrate their "knowledge" and hence gave them power.  The Shamans of Amazonia still use plants this way.  The concept of pharmacology has roots in very old medical traditions of the Chinese, Greek, Indian, Japanese, Muslim societies.  It was not until the 19th century that there was systematic study. We also found that, as we hit new environments, there were new problems and we had to search for answers.  E.g., with long-distance ship travel, scurvy became a problem for the first time. Captain Cook forced his men to eat fresh food on these ships, thus preventing scurvy. This is the first example of preventive medicine we know of. 

Present and Future:  We are now facing a new environment again - space travel.  We know that a very large percentage of former astronauts suffer from cataract disease.  Indeed, almost all of those on the Apollo Missions to the Moon have serious eye disease. Faced with this challenge, we need to find the botanical that is missing in a long journey to outer-space, particularly if we think of going to Mars. Dr. Barnes also spoke of chocolate as a most important healing botanical -- not the chocolate mixed with fat and sugar, but pure chocolate.

The Eclectic and homeopathic movements in America relied on plants for health and for healing. This was then superseded by the synthetic chemistry of modern pharamcology.  That was put into law by the Food & Drug Acts of 1906, 1930 (establishing the FDA), and 1938 -- which set the scene for big Pharma based on synthetic compounds. We should note that these drugs are first discovered and isolated in physiology, e.g., insulin. Then derivatives are synthetically made. And over the past 60-70 years, many diseases receded because of what we found.  But then, we find diseases we cannot treat.

It is also of note that quite often the discoverer does not get the credit.   For example, penicillin and its antibacterial action was discovered first by John Tyndale in 1875 and reported that year to the Royal Society. It was then rediscovered by Ernst Duchesne in 1896.  And then rediscovered by Sir Alexander Fleming in 1928. Then, in 1935, Sir Howard Florey and Sir Ernst Chain discovered it again -- and this time (1945) received the Nobel Prize for its discovery.

In 1990 we began the era of Combinational Chemistry. This quickened the search for successful therapeutics. Using robotics, hundreds of thousands of compounds can be synthesized and tested each day. This approach is remarkably unsuccessful.  NIH has now embarked on a small molecule search. Will it work?  I do not think so.

It is better to look at life itself:  the chemistry of things that work in living systems of life, as we have for the past 3.5 billion years.  In my opinion, here is where we will find answers.

Dr. Briggs then commented.  She asked whether NCCAM is now doing what it should in this area?  Are we going in the direction that we want to go?  Comment:  Obviously, this is an area of great interest to her -- confirming what I saw upon her visit to Tai Sophia Institute a few months ago.

2007 NIH Survey of 30,000 households

Dr. Nahin then reported on the 2007 NIH survey of 30,000 households, approximately 75,000 persons, and a comparison with the 2002 survey.  The 2007 survey is on-line with NIH.  For CAM usage, NIH collected information from 23,923 adults and 9,417 children, asking what they used CAM for, including how much CAM was used for wellness, when is CAM used in relation to the use of conventional medicine, what specific CAM types are used for different types of conditions, what were the reasons for starting to use CAM, what were the reasons for stopping to use CAM.

In 2002, the use of CAM as defined was 36%, in the preceding year.  In 2007, it was 38.3%, but in the preceding 30 days­. Comparison is not valid.

A few comments:   In 2002 the use of CAM as defined was 36%, in the preceding year.  In 2007, it was 38.3% in the preceding 30 days­. My observation:  if someone had gone to a chiropractor, or an acupuncturist, or a massage therapist several times in the preceding year, but not in the preceding thirty days, he or she would not be picked up in the survey; thus the comparison is less than fully valid, as was noted by Nahin.

Based on this survey, there are 3.1 millions persons using acupuncture.  This is still small when compared with non-vitamin supplements (38.8 million), meditation (20.5 million) and manipulative therapy (20 million), but growing. The next survey will be in 2012.

Concept Clearance: CAM for chronic pain

Dr. Briggs asked for a "concept clearance" of a study of utilization of CAM for treatment of chronic pain.  She stated the following:

 --  The survey shows high use of CAM, particularly chiropractic and acupuncture, for pain.  So, we need to test all of this out.
--   We are trying to look at the healthcare question:  what is it that the practitioner is doing that is working.  Again, she specifically mentioned the chiropractor and the acupuncturist.

NAC members (and Dr. Briggs) who spoke up stated:
 
--  This is a very valuable area of research and should be done.  This is "a real world issue that we should be pursing, what is actually working in the real world."
--  We should convene a group for informal discussions of the topic.
--  Acupuncture is particularly valuable for pain control, particularly but not exclusively for low back pain.
--  We should explore whether the CAM interventions reduce use of conventional medicine, e.g., narcotics, aspirin that burns holes in the stomach.
--  While CAM may save healthcare money (some suggested), that is not the issue (says Dr. Briggs):  We should be looking to the best benefit for the patient, looking at the outcomes; saving money would be a good byproduct but not our principal goal.  It would be good, however, to explore why the public so enthusastically thinks the use of CAM for pain control is cost effective.

Dr. Briggs stated that "we are closest to a large scale trial" for manipulative therapies and perhaps acupuncture, at several sites.  "We are past the R21 Exploratory/Developmental Research Grant stage."  Perhaps we can also do pilot trials for the use of mind-body therapies for pain control.

All voted in favor of proceeding.  No dissents.  (Comment:  this was the only vote taken all day.  Dr. Briggs had stated that "we must" get to this matter as "we need to know whether to proceed.")

Future thoughts

Dr. Briggs for the future:
--  We need to go into a period of budgetary growth in order to move our mission forward.
--  We need to look at our R21s; too many have not grown programs at their home institutions.
--  We need to see if pilot projects really pilot anything.
--  We need to bring more CAM practitioners to the table of clinical trials; that has to occur for successful research in the future.

Next meeting of the National Advisory Council is February 6, 2009.

Sherman L. Cohn, Professor of Law
Georgetown University Law Center
600 New Jersey Avenue, N.W.
Washington, D.C. 20001-2075
tele:  202-662-9069; fax:  202-662-9411