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 ...

• 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.

"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

"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

"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

"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

"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

"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

"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

"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

"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

"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

"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)

"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

"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

"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

"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

"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

"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

"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

"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."

"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 

"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

"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

"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

"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

"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

"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

"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