Dr. John W. Apsley, II, Executive Director
Immunogenic Research Foundation, Inc.
27815 SE 26th Way
Fall City, WA 98024

Ph. 425-441-8282 / Fax 425-441-8383
www.IMREF.org // Execdir@IMREF.org

I have the following opinion to share with everyone on these three matters –

Ø       CODEX,

Ø       the Trilateral Cooperation Charter, and

Ø       FDA push for CAM regulatory control over state's rights.

In my opinion, what is at stake here is:

(A)    Compounding pharmacy authority in interstate commerce (FDA à CAM authority push);

(B)    CAM practices standards of care, i.e., CAM procedures (also the FDA à CAM authority push); and

(C)    OTC health products (Trilateral Cooperation Charter - the new strategy to integrate CODEX into the U.S.); and

(D)    The suppression of CAM via strategic use of the Daubert Standard.

Thus, this is a quadruple frontal assault coming at us all at once.

The problem is not, therefore, limited to the one area IAHF states below (FDA Trilateral Cooperation Charter), or for that matter, that of NSF either. It is both. And both relate not so much as to “actual law” initially, but rather the problem is the "rule promulgating authority" of the FDA. DSHEA would only exert itself on the very back-end in court and  on one front only – that is, (C) above). This “rule promulgating authority” has always been the venue in which the FDA plays havoc on many fronts at once. Thus, both the efforts being looked at by IAHF as well as NSF should be addressed.

It does not matter what the law says, the rule promulgating authority enables the FDA's use of unlimited tax payer's monies to go after A, B & C above – e.g., CAM individuals (typically manufacturers) in alliance with state medical board authorities (who first identify and then go after the individual physicians). Thus, they create a one-two-three punch, going after all sources of undesirables from all ends possible, hurting them financially well before they have their day in court. The strategy is merely to drain their resolve and finances, forcing a consent decree to be signed by the party under financial duress.

The issue is that CAM practices and CAM standards of care are currently governed by state law - not federal, which exempts CAM practice strategies from established medicine's "standards of care" definitions as well as FDA authority. IN the past, this has been the key legal strategy to go after CAM practices – that is – that they have violated established medicine’s standards of care with their peers (peers meaning conventional practitioners only, as represented on the State medical board).

To complicate matters, the FDA has successfully over the past 4 years inserted their "bought and paid for administrators" at the National Council on Complementary and Alternative Medicine (NCCAM) as the authoritative body on just what CAM practices should and should not be approved for in the eyes of many in Congress. This sets up a significant court strategy in light of the circa 1993 DuPont Breast Implant Supreme Court ruling (I think this is now known as the Daubert Standard – see: http://en.wikipedia.org/wiki/Daubert_Standard) – wherein expert testimony would be superceded by peer-review publications, the kind now underway via NIH, NCI in conjunction with NCCAM on just what is and is not valid CAM practices.

In the past, state medical boards go directly to the FDA for guidance, and with the FDA supplied ammo have been able to take the licenses of CAM practitioners, or shut them down from CAM practices easily in states not protected byCAM statutes. But with the recent victories of states' rights over this FDA/state medical board alliance, something new had to come into play to re-empower the original "Inquisition" team.

What we are seeing is the new strategy at work on multiple fronts.

Thus in conjunction with the FSBME directive with the local state medical boards, the Feds with their NCCAM "authorities" can weigh in indiscriminately, utilizing with precision the direct targeting arm of the state medical board, and go after interstate commerce products being shipped into CAM practices, plus the individual CAM practice simultaneously. Thus, the FEDS may both regulate the procedure at arms length as well as the illegal/non-approved use of any CAM product treating disease at finger length. The final touch is tat their "media/press" efforts are therefore so bolstered as well.

In many if not most cases they know that if it were to come to a full court press they would lose in those CAM protected states, but they also know they can bankrupt most CAM practices if they go after them one at a time, especially if they foist the notion that the NCCAM has disavowed a CAM procedure. Most physicians do not have enough cash reserves to win the battle of unlimited funds against them, nor do most CAM manufacturers.

Thus, the FSMBE and the FDA know they can easily win in most cases by hard threats against the medical practice by simply promulgating rules (not law), in conjunction with the state medical board. Then the state medical board forces the bluff upon the physician to sign a consent decree, not knowing any better, and they effectively shut down CAM procedures in a CAM protected state.

So, it boils down to (1) Established Medicine's standards of care verses CAM standards of care, plus (2) the CODEX, plus (3) the Trilateral Cooperation Charter - three active fronts.

If the FDA gains the CAM regulatory authority, it may well effectively negate or supercede the hard won CAM state statutes now in place in 15 states in my opinion. And with the Daubert principle in effect and the publications being created by NCCAM, Fed rights may be likely to supercede State’s rights.

Best,

Dr. John W. Apsley, II, Executive Director
Immunogenic Research Foundation, Inc.
27815 SE 26th Way
Fall City, WA 98024

Ph. 425-441-8282 / Fax 425-441-8383
www.IMREF.org // Execdir@IMREF.org

The Immunogenic Research Foundation, Inc. (IMREF), is dedicated strictly to educational and research endeavors. IMREF is a 501(c)3 non-profit corporation. All information contained herein is for confidential/educational purposes only. It is not intended to be construed as medical or legal advice. If a legal question arises, always consult with a qualified attorney before incorporating any educational materials into clinical practice.