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April 11, 2007 at 3:39 am #138373JaxKeymaster
(posted by ms. gypsy solo)
please read the following, please visit the www sites …:
This is very important.
There is a crisis in health freedom. On April 30, 2007
the FDA will close the public comment period on a “Guidance”
which will classify every alternative practice as medicine so that
only licensed physicians can carry out the procedure
AND vitamins, minerals, herbs, etc., will suddenly become
“untested drugs” which will be forbidden.
But public outcry can stop this assault on your health and your freedom.
I want to assert my fundamental right to control my own health and health care.
I want Complementary and Alternative Modalities (“CAM”) to be freely available
and I endorse the comments of the Natural Solutions Foundation
which were submitted on April 6, 2006 and which follow:
Let CAM Continue to Develop Freely
Here is a message you can send via the website link at the end of this message:
To: Food and Drug Administration
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine,
Rima Laibow, MD and Ralph Fucetola, JD on behalf
of Natural Solutions Foundation with regard to the
Food and Drug Administration’s draft “Guidance for Industry
on Complementary and Alternative Medicine Products
and Their Regulation by the Food and Drug Administration.”
They are submitted with reference to the request of FDA
for comments on the proposed Guidance
stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt,
recognized nongovernmental organization active in the United States
and internationally, communicating Natural Solutions to the
many health problems caused by government intervention,
with emphasis on FDA and Codex Alimentarius
over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM),
including traditional remedies and nutrition to achieve
and maintain a healthy status, are preferred by many Americans
to so-called “standard” allopathic medical treatment,
primarily due to the well-documented iatrogenic
death and disabilities, the dangerous side effects
and persistent failures of the so-called “standard” model.
The Dietary Supplement and Natural Remedies market
has grown to over $28 billion dollars annually as Americans
consistently vote with their dollars choosing CAM products out of un-reimbursed funds.
The Foundation urges the FDA to take into account an important
legal distinction that FDA appears to ignore totally in the draft Guidance.
That distinction is between “treatment of disease” and “therapies that may benefit.”
In keeping with that distinction, explained below, it is suggested
that the Guidance be titled, “Guidance for Industry
on Complementary and Alternative Modality Products
and Their Regulation by the Food and Drug Administration.” CAM
is not “medicine”, does not rest in medical models and allopathic methods
and does not seek to be considered “medicine.”
In fact, CAM seeks to shed the appearance of “medicine”
which is not in keeping with CAM traditions and activities.
We request the FDA take the following steps:
(1) hold public hearings on the proposed Guidance;
(2) formally revise the Guidance title to replace the word
“Medicine” with “Modality”
and (3) use of the terms “therapy” and “therapeutic”
with reference to Complementary and Alternative
Modality health practices, instead of the words “treat”
and “treatment of disease” which are used exclusively in the draft Guidance.
The terms “treat” and “treatment of disease” are, in fact,
antithetical to CAM therapies.
CAM health practices can be generally defined as traditional
or other practices that are used by individuals, often for self-help,
to achieve and maintain a healthy status, either on their own
or complementary to standard medical care.
These practices do not include the potentially dangerous use of
invasive techniques and toxic drugs that are the sole province of licensed medicine.
They do, however, include developing therapies and nonstandard approaches
that are outside the scope of licensed medicine.
Such approaches as Nutrition, Homeopathy,
Hands-on-Healing, Magnetics, Sound Health,
Energy Therapies, Biofeedback, Meditation, Breath Work,
Reiki, Chi Gong, Tai Chi and Herbology are examples
of complementary and alternative therapeutic practices.
Traditional Chinese, Ayurvedic medicine or folk remedies
and “Dr. Mom” home remedies are also examples of CAM practices.
These practices aim, in the words of the late Philip J. Hodes, PhD.,
at “more efficient physiological integration and function
of the human organism, leading to optimal wellness.”
This definition is the polar opposite of non CAM practices
which seek to suppress or ameliorate symptoms
without an approach to optimal wellness.
The terms “therapy” and “therapeutic” do not occur,
for example, in the context of the Dietary Supplement
Health and Education Act of 1994 (DSHEA).
Rather, that statute, passed by unanimous Congressional Consent,
tells us that Dietary Supplements may not
“diagnose, treat, cure or prevent” any disease.
It does not specifically forbid the use of the word “therapy”
(or “therapeutic”). Under the Supreme Court’s rule
in the Thompson v Western Medical case,
we should expect that these words would not be forbidden
by the Courts and should not therefore be overtaken by the regulators.
Further, the Code of Medical Ethics of the
American Medical Association also acknowledges
an independent use of the term “therapy.”
The original Hippocratic Oath, with its injunction to
“Do no harm.” has been replaced by a complex Code
detailing the relationship between physician and patient
and alternative practitioner.
Changes made during the early 1990’s were inspired
by anti-trust lawsuits brought (and won) during the 1980’s
by chiropractors and other non medical practitioners.
These changes are just now becoming recognized by regulators and courts.
While “treatment which has no scientific basis” remains condemned (Opinion 3.01),
under Opinion 3.04, physicians are free to “refer” a patient
“for therapeutic or diagnostic services to another physician,
limited practitioner or any other provider of health care services
permitted by law to furnish such services, whenever he or she
believes that this may benefit the patient.”
Thus, unscientific “treatment” is distinguished from
“health care services permitted by law.” “Treatment”
— which means the use of standard medicine and surgery to “cure” disease
— is distinguished from other health care services (therapies)
which need only meet the lesser “may benefit” standard.
While physicians “prescribe” treatments for disease,
therapies that may benefit may be subject to “referral”
thereby further indicating the distinction.
Thus, for example, Dietary Supplements that support
normal structure and function to support therapeutic outcomes
can be seen to complement licensed medicine, but not
to be held to its strictures, nor limited in its practice to licensed physicians.
Since such therapies are not prescription services, members of the public
may choose such services without the permission of their physician.
Purveyors may restrict sale of therapeutic products to physicians,
complementary practitioners, exercise and health care professionals,
although they should not be required to do so.
We have analyzed the word “therapy” and the similar word “therapeutic”
because these words are not forbidden by DSHEA
and are referenced by the AMA Ethics Code.
We recommend “Therapeutic Nutritionals”
for alternative practices centered on Nutrition.
We recommend the use of the qualifying word, “Nutritional”
in this context to make it completely clear that the practitioner
is not offering “treatment of disease.”
The claims made for Therapeutic Nutritionals must, of course,
be allowed Structure and Function Claims.
Thus, for example, under current law as interpreted by the FDA,
one cannot claim that a nutrient lowers cholesterol levels –
since there is now a “disease” of hypercholesterolemia –but can
claim that a nutrient maintains normal cholesterol levels
for persons with normal cholesterol.
A purveyor may say that a certain combination of multivitamins
was designed to maintain normal structure and function for a person with diabetes,
but not that the combination “treats” diabetes or affects the blood sugar level.
Similarly, any Health Claim made for any alternative practice
must meet the FTC standard of “truthful and not misleading”
and must be based on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure and function
and are not prescribed as treatment for medical or psychological conditions,
nor for diagnosis, care, treatment or rehabilitation of individuals,
nor to apply medical, mental health or human development principles.”
As the High Court said in Thompson,
“We have previously rejected the notion that the Government
has an interest in preventing the dissemination of truthful
commercial information in order to prevent members
of the public from making bad decisions with the information
* * * Even if the Government did argue that it had an interest
in preventing misleading advertisements, this interest could be satisfied
by the far less restrictive alternative of requiring … a warning…”
What is the proper level of substantiation for CAM nutrient or health claims?
It is not the “significant scientific agreement” required of drug claims,
but rather, the general “competent scientific evidence” standard
that applies to all commercial claims.
That does not imply that purveyors need to have multiple
double-blind experiments (as may be required for drug approval).
Substantiation merely needs to be competent and scientific.
We urge this to include research studies
(which is when scientists review the work of others
and apply it to specific questions) and clinical trials
(which may be as formal as double-blind,
placebo controlled investigations but need not be,
since multiple variables, like those involved in CAM practices
designed to promote optimal health, are not well studied
by double-blind, placebo controlled investigations)
as well as traditional knowledge, clinical case studies,
observational reports and clinical experience.
All of these sources of information and experience have a role to play,
but ultimately, such substantiation must rest on the informed professional
opinion of some credentialed or appropriately experienced person
who can (in the case of Dietary Supplements, for example)
sign onto the Structure and Function Claims Notice to the FDA,
attesting that “the notifying firm has substantiation
that the Statement to which this Notice applies is truthful
and not misleading.” (Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors a market approach
to these issues and urges the FDA to reduce regulation
to those minimum levels that will encourage the continued
rapid development of CAM approaches.
Especially when dealing with Dietary Supplements and Traditional Remedies,
we are dealing with foods which, as foods, are presumed to be safe.
There is no need for the high level of regulation that is required for the dangerous
and invasive drugs and techniques of so-called “standard” medicine.
Even with this stringent level of oversight, drugs are a major cause
of death in every developed country while CAM remedies
are an insignificant-to-absent cause of death world-wide.
Rather, this is a situation where the public is best served
by a policy of Laissez-Faire: allow CAM to develop freely
in the public interest.
Throughout the world today people are looking to traditional
methodologies and leading-edge CAM techniques
because they offer alternatives to toxic, expensive drugs
with their dangerous side effects, un-manageable and unreasonable costs
and other invasive technologies of modern medicine.
This search for alternatives is protected by the fundamental right
of individuals to communicate and learn; to heal and be healed.
This has been settled law for over a hundred years.
“The state has not restricted the cure of the body
to the practice of medicine and surgery — allopathy, as it is termed,
— nor required that, before anyone can be treated
for any bodily ill, the physician must have acquired
a competent knowledge of allopathy and be licensed by those skilled therein.
To do that would be to limit progress by establishing allopathy
as the state system of healing, and forbidding all others.
This would be as foreign to our system as a state church for the cure of souls.
All the state has done has been to enact that, when one wished
to practice medicine or surgery, he must,
as a protection to the public [not to the doctor],
be examined and licensed by those skilled in surgery and medicine.
To restrict all healing to that one kind — to allopathy, excluding homeopathy, osteopathy, and all other treatments —
might be a protection to doctors in surgery and medicine; but that
is not the object of the act, and might make
it unconstitutional, because creating a monopoly.”
North Carolina’s Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require that the distinction
be made and maintained by the FDA between “treatment”
and “therapy” if the US Constitution and public are to be served.
Dated: April 6, 2007
Maj. Gen. Albert N. Stubblebine III, (US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
Ref: Federal Register: February 27, 2007 (Volume 72, Number 38
[Notices – [Page] [wais.access.gpo.gov – DOCID:fr27fe07-95]
Spread the word!
Tell everyone in your Circle of Influence, professionals,
alternative practitioners, nutrient and herb companies, everyone!
Let them know how important their participation is to make sure
the FDA backs off from this repressive course.
Please share this link with them and urge them to take action:
Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation
http://www.HealthFreedomUSA.orgMay 19, 2007 at 7:06 am #144077DecsunaParticipant
As a member of the medical “guild”, and a sworn scientist, i have always had my own take on alternative medicine. If you ask me, alternative medicine is nothing but basing clinical methods on (yet) scientifically unfounded grounds. Any scientist, that sees a phenomenon, should try to explain it, not.. Well, ban it.
We have all seen that many metods of altenative medicine have results. Results, that can be statistically proven. Therefore, there must be mechanisms behind these methods that act on cetrain physicological processes to turn them the desired way – much like any other treatment. The problem is, we do not understand these mechanisms. But did not understanding something ever stop the scientists before us? More on the contrary, it sparked their curisity, and led them into research. The goal shouldn’t be to institutionalize alternative medicine as alternative, or to even ban it.. But instead to conduct research that will explain its methods, integrate them into “conventional” medicine, and perhaps, through understanding of their mechanisms, improve them.
It is understandable why this happens – it it is due to the established pharmaceutical and medical companies, that don’t want alternative medicine taking away their business. The point is, the pharmaceutical industry *needs* people to be sick – if more people choose healthier lifestyle and a more natural way of living, most of their business will be gone.May 24, 2007 at 5:57 am #144171JaxKeymaster
Guiding the Guidance
The Natural Solutions Foundation was so distressed by the abusive and dangerous “FDA Guidance on CAM Regulation ” that we urged people to voice their strong objection to it directly to the FDA. And 185,522 folks did just that! Of course, 445,235 people tried to submit their comments but, because of constant interference with our links and our site, could not get their comments in to the FDA. To help those who had difficulty with the links, I hired 3 fill time people to submit their comments for them since our link continued to work (most of the time) so we were able to submit a huge number of comments that way (which we called “Plan B”).
“Abuse of Power”
You may recall that the Natural Solutions Foundation applied for an extension of the Public Comment period for this skewed and alternative-medicine-hostile FDA “statement of the law” which is, in reality, what Congressman Ron Paul, MD describes as “an abuse of FDA power”.
Well, we got our extension, but very, very grudgingly! Although the Public Comment period was closed on April 30, because of our request for an extension, it was reopened for a meager few days!
We have until May 29, 2007 to get it through to the FDA that their “Guidance on CAM Regulation” is, in fact, a serious misstatement of the law. Our legal analysts believe that it is an apparent preparation for “enforcement” of that misstatement of the law against all natural procedures and products. This is not acceptable to the American public. We need to tell the FDA that in no uncertain terms.
This is the guidance that says …
For example, the guidance says that if the intention in using (or giving to yourself or another person) a food, juice or “CAM Product” [there is no such category but it would seem to refer to supplements, herbs, wheat grass juice, etc., etc.], that item then becomes an untested drug through your intent alone. Untested drugs are illegal in the US and abroad.
The guidance defines “CAM” as “Complementary and Alternative Medicine”, not “Modalities” or “Medicines” so that any CAM modality of any sort (energy, nutrition, massage, acupuncture, homeopathy, etc.) could become a “Physicians only” activity.
Licensed physicians who carried out these treatments instead of following “practice algorithms” (that means drugs) could face disciplinary action including the loss of their licenses and FDA raids by armed marshals and dogs on their offices.
By the way, there has been a lot of internet discussion about whether or not the CAM Guidance is really a threat. Frankly, after reading what has been circulating on this question, those who do not believe that it is a real threat either do not get it or do not want to get it.
The threat could not be more real.
The FDA Office of Policy and Planning has taken the time and effort to mis-state, extend and distort the law setting up the most draconian interpretation of how to restrict CAM — read pharmaceutical free — treatments and therapies.
What do 2/3 of Americans do? They use CAM treatments and therapies. What do the drug companies want to do about that? Smash, totally eliminate, literally kill the most powerful competitor for treatment dollars this side of clean, unadulterated food!
Let’s make our voices count!
The FDA acknowledged that they got a LOT of comments from us (if you remember, comments through our website were the only ones getting to the FDA according to the Office of the Receiver of Dockets). Your voice REALLY COUNTS when you submit your comments through the Natural Solutions Foundation Site, http://www.HealthFreedomUSA.org . The battle is far from over. Submit your comments now if you have not already done so. Even if you have sent in your comments through our site, please send this email with a brief introduction to your friends and colleagues asking them to submit their comments as well.
To submit comments, go to http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185
If the link is blocked (or broken), send an email to me at firstname.lastname@example.org with “Submit-CAM” in the subject line and your full name and address in the body of the email. We’ll make sure your comments are submitted to the FDA!
Here is what Ralph Fucetola, the attorney who applied for the extension on behalf of the Natural Solutions Foundation, has to say about the FDA’s hostile and inappropriate response to the Voice of the People:
ANNOUNCEMENT JUST POSTED ON THE VITAMIN LAWYER HEALTH FREEDOM BLOG
05/23/07 2:10 PM – FDA CAM Guidance Period Extended – a bit…
I just received a phone call from Philip J. Chao, FDA author of the CAM
Guidance to let me know that FDA just published an announcement that the
comment period has been extended through May 29, 2007.
The announcement is at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-nec0001.pdf – that statement
indicates, “Public concern based on misinterpretations of the draft guidance
has generated a large volume of comments to the docket.”
I take strong exception to this characterization of public demands to protect
our alternative practices. The FDA still doesn’t get it. Upon whose authority
has the public concern been determined to be based upon “misinterpretations?”
The FDA makes the Guidance and then judges the opponents as “misinterpreters”
– this is the hallmark of bureaucratic hubris. The Agency can’t be wrong, so
the public must be. Even when, as Congressman Ron Paul put it, the Guidance is
“an abuse of FDA power…”?
There is a clear disconnect between the Agency, Congress and the public —
with Congress supporting the public! For example, when the Senate earlier this
month wrote DSHEA protective language into S.1082, the FDA empowerment law now
before the House. It is therefore more important than ever that the House act
to enhance the Senate language by exempting all compounded, nutraceutical,
bioidentical and functional foods.
Ralph Fucetola JD
All rights reserved.
FDA Serves Pharma Masters,
The marketing arm of the pharmaceutical industry, also known as the FDA, wants to take down all competitors to drugs. All of them. If that is not what you want, now is the time to act. Click on this link (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185) (http://tinyurl.com/2u7ghc ) to tell the FDA to correct the abusive power it has laid out for itself in its “Guidance on CAM Regulation” and then click on this link (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344) (ttp://tinyurl.com/27oab6 ) to direct the members of the House of Representatives in no uncertain terms to protect your health and your health freedoms from the dangers of Senator Kennedy’s ill advised and devastatingly poorly conceived, but very, very “pharma phriendly” bill, S. 1082.
Thanks for your activism. We have to stay on these issues and that will mean a lot more emails and a lot more activism before this is all over.
I know how hard this is and I thank you from the bottom of my heart for staying the course. This is a long, drawn out battle but we will win in the end if we stay focused and motivated.
Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation
PS: You know those three people I hired to submit for you when the links did not work? They get paid. The airline tickets to get to the Codex Meetings and conferences where we spread the message? They cost money. Hotels? Meals? Rental cars? Brochures? Telephones? Ditto. This is your battle. Please make a generous tax deductible donation (recurring donations really help us plan our budgets!) at http://www.healthfreedomusa.org/index.php?page_id=189.
In addition, we have created an all-organic products shop for you. http://www.Organics4U.org allows you to protect your health and your health freedom at the same time! Your purchases are 40% tax deductible, too.
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