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Your Comments: Integrator FDA Articles Stimulate Huge Array of Links, Thanks, Blasts and Queries |
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Written by John Weeks
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Your Comments: Integrator FDA Articles Stimulate Huge Array of Links, Thanks, Blasts and Queries
Summary: The Integrator
Special Report on the FDA's Guidance for the Industry on Complementary
and Alternative Medicine stimulated more response than any other Integrator article thus far. Response ranged from thanks to reprimand. Some blasted the Integrator for
allowing the FDA's Phillip Chao to speak. Others credited the Integrator
with bringing a modicum of reason to a hugely politicized and polarized
environment. Here is a sampling of comments. I share these with Integrator readers in part to show the wildness of response, and also to bask briefly in the satisfaction of having provided a service. Thanks to the Integrator sponsors and contributors who make the work possible ...
Striking a Chord Among Organizations and Newsletter Writers Seeking Balance
My decision to approach my recent Special Report on the FDA CAM Guidance by seeking to understand what is the appropriate response struck
a chord with many individuals and organizations. The Special Report was either cited or referenced affirmatively by a score of organizations, blogs and newsletters. They indicated pleasure either with the diversity of organizational perspective and/or the attempt to ground the discussion. Among the organizations or writers
which linked to the Integrator or its content are:
- American Botanical Council
- American Holistic Nurses Association
- Alternative Medicine Foundation
- Organic Consumers Association
- American Association for Health Freedom
- Washington Association of Naturopathic Physicians
- International Society for Complementary Medicine Research
- Natural Health Line
- Corporate Health Improvement Program (CHIP) members and advisers
- Health World Online/Healthy.net newsletter
- Gary Null's newsletter/site
- Reiki Update
- The Acupreneur
- CAM Law Blog
- Alternative Health Insurance newsletter
- Central Pennsylvania Holistic Health Networking
- Leavenworth Echo.
 Integrator sponsor - making the report possible
Others, such as the Natural Products Association and some of the flame-throwing health freedom groups, linked readers to the Integrator interview with FDA senior policy advisor Philip Chao.
Comments and Responses from Individuals
The following is a selection from people who sent me notes of thanks (I asked for permission from most to publish) and some who were more clearly writing for public consumption as part of the Your Comments notes which run with Integrator articles.
1. Retired Clinical Psychologist/Nutritionist Not Convinced by Chao Interview
"The FDA's past history doesn't
inspire confidence and trust in what Chao claims he and his FDA colleagues are
doing now. Since the FDA has stated that 'only a drug can
cure, prevent, or treat a disease,' the FDA has been operating on the
basis of a contrived lie that has been highly beneficial to drug
companies. Well researched health effects of fruits, vegetables, and
dietary supplements cannot be claimed because the claims 'haven't been evaluated by the FDA.' How many young people
have needlessly died of sudden massive fatal heart attacks from magnesium
deficiency because supplement manufacturers could not legally, according to the
FDA, relate magnesium to cardiac health and function? For years, the FDA
has been much better at playing legal-semantic games than scientific
integrity.
"When it comes to the FDA's
activities, including supporting CODEX, I will remain extremely
vigilant. Your interview with Chao does not convince me otherwise."
Richard Malter, Ph.D.
Retired Clinical Psychologist
Nutrition Counselor
2. President Emeritus, AAAOM
"Well done!"
William R. Morris, LAc, MEd, DAOM
President, Academy of Oriental Medicine of Austin
President Emeritus, American Association of Acupuncture & Oriental Medicine
Editorial advisory board, Integrator
 Integrator sponsor - making the report possible
3. Veteran of FDA Battles
"I feel you folks have let me down badly! I didn't learn of the FDA's nefarious
proposal until I saw an information sheet in a healthfood store, AFTER the
comment period. The FDA tried to outlaw
herbs and supplements once before, in the Clinton Administration, and it was
only concerted action that prevented them from doing so. I want to be notified of ANYTHING along this
line, so I can kick up a fuss, and if you folks won't do it I'll find some
OTHER newsletter."
Bruce Duncan
4. Long-time Integrative MD and Mind-Body Leader
"Thanks, John. Great coverage - a real service. I
forwarded to my nutritional medicine group."
Martin L. Rossman, M.D., Dipl. Ac. (NCCAOM)
Greenbrae, California
www.drrossman.info
5. Holistic Nurse and Former Hospital Administrator on the Interview with Philip Chao
Mary Beth Davis, RN, a former holistic health administrator at Deaconess Hospital in
Evansville, Indiana, wonders what kind of action might break the stuck
energy between the natural health field and the FDA.
"I deeply appreciate the work that you do. Your interview with Chao was
fascinating. It is amazing to me that (the FDA is) not considering an extension
of the official response time for the public. Even Darth Vader started with
pure intentions turned to the 'Dark Side' and then softened in the end.
"I
know we need to voice our opinions in this 1% world. It is our
responsibility to challenge those that are not considering the best interest of
the larger community. I was on the phone to our congressman, Brad Ellsworth
today. I wrote him and sent him your blog link. I do also believe that we have to work in the 99%. As Albert
Einstein - I think it was - voiced, you
cannot solve a problem on the level of thinking at which is was created.
"Are you familiar with Dr. David Hawkins and his
work with mapping energy frequencies? His book “Power vs Force” addresses
this. We have to rise to a different frequency to TRULY address these
hard issues. I am talking about people sending individually or in groups,
prayer, Reiki, positive thoughts or energy with the intention of positively
affecting a situation or person. I guess I am saying that raising the
consciousness of those involved in developing policy and those affected by the
policies is the only way to achieve the highest level of change. A few
people working 'up above the battle ground' can, do and will change this or
any situation for the better.
"I believe that 'crying wolf' is harmful. I am sending your blog to an MD friend of mine
who is just opening her Integrative Med practice here in Evansville. She does not seem too
concerned about this."
Mary Beth Davis, RN
Holistic Health Resources
Evansville, Indiana
6. Cancer Survivor, Intelligent Soul, Mistrusts FDA
"After reading the interview, nothing really
changes my feelings. My feelings are: I do not trust the FDA any
longer...not one bit. Too much of their funding comes from the 'fox.'
"I do not want the government, in any capacity, involved in
my health care. I am a college educated, intelligent human being. I am
willing to be responsible for what goes into my own body. I am willing to
pay for my own care. I want complete freedom to choose my own licensed
healthcare practitioners. I want my health insurance company to support
my decisions and choices to choose homeopathic, naturopathic or allopathic
medicine. So until my government is willing to guarantee me those rights
in writing, I am unable to trust that government or any of its agencies.
"I am a cancer survivor of 6 years...thanks to 'alternative' medicine."
Respectfully,
Cathy Vallecorsa
Glendale, AZ
 Integrator sponsor - making the report possible
7. NIH NCCAM Staffer (Who Wished to Remain Nameless)
"I can’t comment on the FDA guidance, but I did want you to know
that I think the Blog is providing a very valuable service to the
community. You are doing a great job."
Professional staff person
NIH National Center for Complementary and Alternative Medicine
8. Past Chair of Naturopathic Accrediting Agency, Father-in-Law
"Thanks for your report and all the research that went into it. My
daughter-in-law (who lives in N.Y. state) had asked just last week what I knew
about it (she had received a "flame thrower e-mail" and was very
concerned). I couldn't give her much info ... however, I just forwarded
your report to her which should answer all her questions. Thanks for all
you do on behalf of the CAM community. You are an amazing asset."
Don Warren, ND, DHANP
Private practice, Ontario
Past President, Council on Naturopathic Medical Education
9. Drug Companies and the FDA Are One and the Same
"The FDA and the drug companies are one and the same. All
you need to do is look at what the drug companies and GMOs want,
that will answer your question as to what the FDA is doing."
Dave Sanford
10. President and Immediate Past President, American Holistic Nurses Association
"Thank you very much. This is really helpful. I was
going to ask if you would do a piece in the Blog. I have been overwhelmed with various
documents about this issue and AHNA is planning a response after our Leadership
Council meeting on Saturday. Note that
the date for comments has changed to May 27th which gives us all more time to
respond. I have also been writing a
chapter in Barbie (Dossey's)'s 5th edition book on holistic nursing on Issues and Trends
in Holistic Nursing. Have used some of
the info in the Blog Any other ripe
news?
"John, you truly do a wonderful service through the
Blog. Thanks for being there. Be well."
Carla Mariano, RN, EdD, AHN-BC
Faculty, NYU School of Nursing
President, American Holistic Nurses Association
Editorial Advisor, Integrator
___________
"I have forwarded and shared your Integrator latest
email. It has made a huge impact in terms of understanding the issues. Thanks so
much for your publication on line. I always share it with folks whom I think can
use it! (I sent this to) the Council for Healing which Dan Benor founded ... really
appreciated it!"
Sonja Simpson, RN
Past-President, AHNA
 Integrator sponsor - making the report possible
11. Nurse: Guidance is an Undercover Move by the FDA
"If this is not an undercover move by the FDA then I
wonder why they took it off the net for several days. And I wonder why, now, everytime I try to
print it, it is unreadable. It is not my
printer.
"It is printing everything else just fine. At first, when I tried to get into the FDA
website, it locked up my computer and I had to manually shut down. I tried several times after that in the same
morning to get my computer going and it locked down. About 2 hours later I turned it on and it
came on without hesitation. Then I went
to the PDF CAM guidance site and the subject would come up but not the guidance
document. That went on for almost a
week. When I finally got into it, it is
unreadable in print, as I said above. Any comments?
Ann (RN)
12. A Natural Products Attorney
"Thanks John. This was a great
article. You covered all the bases, even Michael Cohen! Very cogent and I think
might be a good basis for community discussions about where this area is
headed, even if it was perhaps a restatement of FDA's view of its present
authority.
"One potential issue I see is
the use of this proposed guidance as evidence against a CAM practitioner
in a state administrative proceeding since FDA is clearly stating that it
has no authority to regulate the practice of medicine. Could state medical boards
use this as a rationale for imposing more regulation? I don't know the answer.
Not even sure if this is the right question!
"Thanks again. Hope you are well."
Debra Bass, JD
Natural Products Attorney
13. Marino Center Integrative MD - Failure to Mention DSHEA
"I read your article on the latest FDA Guidance document at http://www.organicconsumers.org/articles/article_4988.cfm You asked at the end for reader feedback so here is
some. I am a physician who practices at
an integrative medicine center. The
majority of my patients use one or more of herbs, supplements, and homeopathic
remedies, so I have educated myself about these and I regularly discuss
them with my patients.
"I appreciate your research and your inclusion of various
viewpoints. The points you made about
considering this document in the context of the evolving views at the FDA, and
not as a single 'hit' requiring heroic reaction, seemed particularly
apt.
"What is missing from your article is any mention of
DSHEA [Dietary Supplement Health & Education Act]. I am very pleased with DSHEA and
how it has improved my patients' access to a wide range of products that they
can then try (with appropriate guidance) to see what helps their unique
individual metabolism and biochemistry.
My reading of the Guidance piece is that it adds another
building block for an eventual "end run" around DSHEA. It does not undermine DSHEA by itself, but it
supports the "medicalizing" and labeling as "drugs" or
"medical devices" of items that DSHEA clearly leaves alone so long as
no unsupported claims are put on their labeling. If these items are reclassified as "drugs"
then DSHEA suddenly stops applying to them and their sale requires FDA approval
under a far stricter process.
"My objection to the "Guidance" piece is this:
by establishing a vague criterion of "intent" in defining the
boundary between a supplement and a drug, it leaves DSHEA vulnerable. Campbell's observations at the end of your
article summarize the problem well.
While it seems preposterous that chicken soup would ever be classified
as a 'drug' because I intend it for helping my child's sore throat,
the 'intent' behind most supplements (glucosamine, St John's Wort,
echinacea, etc.) could be defined by a zealous bureaucrat as a medical
intent. And I would agree with the
bureaucrat: when I recommend a
supplement, the basis for it is to support treatment of a medical
condition. So I think it's good to put
up some resistance at this stage, to protect DSHEA. Thanks for listening."
David Anick MD
Marino Center
14. Furious with the FDA Due to Challenges Related to Illness of Son, Saved by Supplements
A subset of responses were very individualized accounts which had little to do with the specifics of the Guidance but instead evidenced a need to restate some real grief.
"Our son was 13 years old
when he was diagnosis with PACNSV. A very are auto-immune disease that more
than once tried to take his life. The leading researcher at Children's
Hospital Medical Center of Akron. His name was Peter Reuman. They went by
what yawl call medical protocol and almost killed him more than once. The
disease is so rare all the doctor could tell us was how rare his illness was
and to get on the Internet for more help which we did. If it wasn't for GOD
GIVEN natural remedies our son would be dead by now and it is because of
your medical protocol.
"I thank God daily for our son and the life he spared
from this deadly illness. The foundation that we help get
founded (cnsvfinc.org ) asked us to leave their support group because we went
against your so called medical protocol. Up until the time they
(cnsvfinc.org) asked to or throw us off their site all we heard was how the
strong medicines that they (all the patients on the 3 sites) was just
getting worse from the meds and they always would counter with more strong
meds and a let of the people are on up to 30/50 pills a a day to control all
the side effects that those drugs cause. Micah (our Son) is now 16 and he
takes nothing but supplements and vitamins. Again I was I had time to tell
you all the mistakes that the doctors made but they did their very best with
the rarity of his disease. I just wanted to drop a line to let all those who
address this issue to concern what type of impact yawl could have on people
like us who help get a child alive by going to where The Good Lord would have
us go ...... Back to Mother Earth......from dirt we came and from dirt you
will find your cures.
"Thank you."
Ken Lawson
 Integrator sponsor - making the report possible
15. Georgetown Law Professor, TAI Sophia Board Chair, IHPC Board Member
"Good job, John. This is the type of reasoned explanation that
is always very helpful. Having read the
AAAOM views before and having heard the discussions in the Integrated Healthcare Policy Consortium, I am rather
proud of being associated with the responsible CAM
world."
Sherman Cohn, JD
Law professor, Georgetown University
Board Member, Integrated Healthcare Policy Consortium
Board Chair, TAI Sophia
Comment: The first influence on my approach was the reasoned exploration led by Janet Kahn, PhD, IHPC executive director, inside the IHPC just after the March notice iof hte Guidance was included in the NIH NCCAM newsletter. Quick research by my fellow IHPC steering committee member Michael Traub, ND, DHANP, dispelled the worst of the more hysterical concerns by a quick email to associates of his who are owners of natural products firms.
16. Clinical Aromatherapist and Herbalist in R & D at Aveda
"I so appreciate this - I have been addressing
this issue at work too!"
Mindy Green, MS, AHG, RA
Clinical Aromatherapist, R & D
Aveda Corporation
Blaine, MN
17. Two from Executives with Peer Reviewed Journals
"Great job of reporting on all this. Thank you so much."
Bonnie Horrigan, Managing Editor
Explore!
"John—Greetings.
Just wanted to say: YOU ROCK, DUDE! This is a major resource and a great
service to the industry—and I know it took a LOT of time to compile. Very
timely and much needed. Hope all is well in your world."
Frank Lampe, VP Content Development
InnoVision Health Media, publishers of
Alternative Therapies in Health & Medicine
18. "These Money Grubbers Never Have Enough ..."
"Do not believe
everything Philip Chao tells you.
"You and I know what the FDA is up to, and we have
to work very hard to defeat
these stupid regulations. We all know that Big Pharma wants no competition and
these money grabbers never
have enough. DO YOU KNOW THE THOUSANDS of small healthfood stores they are
going to PUT OUT OF BUSINESS? It is all about the money.
"Big pharma makes
millions and they never have enough. They do not care one iota for our health."
Walter Beverstein
19. Unknown FDA Observer
The writer began by quoting a note from the article: "...Without trust about agendas, we cannot have the ground of
shared meaning..." he then continued:
"Frankly, I couldn’t care less about the Natural
Solutions Foundation's Libertarian organizations view on anything. But as far
as the FDA is concerned, NO, I DON’T trust this federal organization. It has
shown too many deviations from what I consider to be acceptable practices, with
the health and well being of not only the America public, but any nation that
has products sent to it from United States manufactures.
"One such incidence, in particular, stands out in
my mind. And although it has no real bearing on the Guidance agenda, it
is a very prominent factor in why the FDA is (and always will be- - -to my
mind) an untrustworthy Federal organization. This incidence is presented here
in shorten form:
“Recently
unearthed documents show that Cutter Biological, a unit of the Bayer drug
company sold millions of dollars worth of an injectable blood-clotting
medicine-- Factor VIII concentrate, intended for hemophiliacs -- to Asian,
Latin American, and some European countries in the mid-1980s, although they
knew that it was tainted with AIDS.
"FDA regulators helped to keep the continued
sales hidden, asking the company that the problem be 'quietly solved without
alerting the Congress, the medical community and the public,' according to the
minutes of a 1985 meeting.' (New York Times May 22,
2003)
"As I said, this is only one of several such
debacles and it shows the depth the FDA will go to obfuscate a danger, or
mislead the American public, not only in our country, but overseas as well.
"Relying on the FDA is dubious at best and tragic
(as was indicated in Hong Kong and Taiwan, where more than 100 hemophiliacs got
H.I.V. after using Cutter's old medicine, according to records and interviews.
Many have since died) as a worst case circumstance."
20. Health Freedom Warrior: Attention Should be Toward Trilateral Cooperation Charter
John Hammell is a health freedom activist with a particular concern
around something he refers to as the FDA's Trilateral Cooperation
Charter with Canada and Mexico. I have not explored the issues he
mentions. He forwarded me this note which he had written to an associate.
"Thanks for sending this- this is useful.
Philip Chao's comments from FDA are accurate and truthful. They dovetail
completely with what I've been telling people about this FDA Guidance document.
It poses no threat, but FDA's Trilateral Cooperation Charter with
Canada and Mexico is another story altogether- that poses a VERY
real threat because under it FDA has already issued more than 730
compliance actions against dietary supplement manufacturers that we know about
(their website hasn't been updated since 2005 and they refuse to respond to my
FOIA request which is going to force me to sue them in Federal District Court
to get their internal documents).
"FDA is acting as though a North American Union were already in place, and all
the energy people have wasted by sending comments on this Guidance Document to
FDA should have been put into pressing for congressional oversight of FDA's
Trilateral Cooperation Charter in Congress. FDA ignores all comments
from the public that don't coincide with their agenda, so its pointless to
communicate with unelected bureaucrats about any Guidance document.
"So far 10,578
people have signed IAHF's petition calling for Congressional Oversight on FDA's
Trilateral Cooperation Charter http://www.thepetitionsite.com/takeaction/373269232#body,
but unless we get at least 100,000. signatures, we probably won't get oversight
due to Pharma flooding members of congress with PAC donations. The spin coming
from the so called 'Natural Solutions Foundation' against our message
has really been hurting our efforts to defend America from its planned
deconstruction.
"If we fail to expose and stop FDA's Trilateral Cooperation Charter and the
whole plan to force us into a North Ameican Union, we fail to defend DSHEA
because FDA's Trilateral Cooperation Charter has a definition of health
fraud thats so overly broad that even WATER becomes a "Drug".
This is the REAL threat which NSF is trying distract people from via their spin
against our message. ------ John Weeks: see http://www.ymlp.com/pubarchive.php?jham
especially http://www.ymlp.com/pubarchive_show_message.php?jham+581
John Hammell, President
International Advocates for Health Freedom
http://www.nocodexgenocide.com
21. Founder, Integrative Medicine Alliance: Useful for APHA Article
"Well done! This is by far the most clarifying piece I've encountered on
this issue, and I'm particularly appreciative that you've gone into some
"big picture" issues, which is where we really need to be focusing
our attention, in my opinion.
"I had just agreed to write an opinion piece on this issue for Beth Sommers for
the American Public Health Association's ACHP newsletter. Without your article as a resource, this would have
been an onerous task.
"I'll do what I can to circulate your blogpost, and will encourage the IMA
Newsletter to publish a link to it as well.
Karlo Berger
Founding President, IMA
22. Nurse Practitioner: Concerned About Effect on Unlicensed Practitioners
"As
a licensed medical provider I personally am not concerned about the right to
prescribe CAM for my patients but I know some very fine herbalists with whom I
have studied for many years. They are not licensed to prescribe medical drugs
(as I understand herbs are to become). Are these people going to be run out of
town or imprisoned for practicing medicine without a license?
"PS.
Thanks for the great job you did in your Special Report of April 18th."
Susan
Collins, RN, FNP-BC, AHN-BC
Family
Nurse Practitioner
23. University of Maryland Integrative MD
"Thank-you for the GREAT
consolidation of information presented in the April 18 Integrator Blog. After spending MANY hours on
line reading and trying to sort through information I still hadn’t arrived at
such a clear understanding of the intent of the FDA Guidance document or what
was the best use of my time and energy in response to the document. I especially
appreciate your interview with Philip Chao, as personally I found the FDA
website slightly difficult to navigate through. THANK –You for once again
providing information that allows me to make informed choices."
Sharon Montes, MD
24. Idaho Reiki Practitioner
"Thanks for such a well-researched and cogent commentary
on this issue. Would that the link to your blog is passed through cyberspace as
vigorously as were the dire warnings from the Natural Solutions folks!
Much appreciate your good work."
Barbara McDaniel
Reiki Healing Arts
Coeur d'Alene, ID
25. Seattle ND: ARe We Missing Our Opportunity to Market Religious Implements ...?
"Nice thorough job.
Pretty good survey of the current (and past) CAM advocacy posture!
"I still do not have a clear idea just what the FDA is
doing other than making a review of its policies and position vis a vis
container delivered remedies. Is not
that what they were doing when they were founded a century ago? Seriously, we should wait to see what is
happening before wasting steam ... and (we should) look into marketing religious
implements of healing before they become outlawed."
William Wulsin, ND, LAc
Seattle
Comment: Bill's tongue was well in cheek.
26. Keep My Rights Available
"I would like to express my opinion
regarding an individuals rights to have access to make decisions regarding
their own healing. I have been reading about and
studying food, nutrition, and alternative therapies for over 35 years.
Although, I may not be a doctor, I do know that I want to and need to have my
rights preserved to make my choices about healing. If you take away
someone's choice, you take away their voice. Please keep my rights available to
make choices in natural health care accessible. Thank you for your help."
Colleen Ostllund
Boulder, Colorado
27. President, National Health Federation
"You wrote a very
nice & thoughtful piece on the FDA's CAM Guidance document. However,
although you mentioned several other health-freedom organizations, you failed
to mention the World's oldest. Since you do not
seem to be familiar with our organization - which maintains a lobbyist in D.C.
as well as is the only health-freedom organization with accredited INGO
Observer status at Codex Alimentarius Commission and Committee meetings, I would
encourage you to visit our website at www.thenhf.com. If you have any
questions about what we do, please do not hesitate to contact me."
Scott Tips, President
National Health Federation
Overall Comment: Pleasing to be of service. Now time to thank those who made the work possible - the individuals and organizations that have sent contributions and the handful of firms that really make it possible: the Integrator sponsors: NCMIC Group, Triad Healthcare,
Standard Process, Alternative Medicine Integration Group and Inner Harmony Group.
Thank you all.
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