To:       Sherry Thomas, Policy Coordinator 
                                                   1/2/2008

            Health Systems Quality Assurance 


            Office of the Assistant Secretary 


            310 Israel Road 


            Tumwater, WA  98504-7850

Ref:      Draft Colon Hydrotherapist Sunrise Review

Dear Ms. Thomas

We appreciate the opportunity to provide comments on the draft of the Colon Hydrotherapist Sunrise Review.

Although the draft is well written, there are some errors of either omission or interpretation that cause the draft to reflect a bias that should not be present in an impartial Sunrise Review report.  The report should accurately report the information provided during the Sunrise Review so the legislative body can make their decision on the bill  H-3505.1/07. 

The first section of the draft provides a review of the Sunrise Process and lists regulations that should be regulated and the types of regulation that may be considered.  There is another benefit of having a Sunrise Review as it provides the Legislative body the opportunity to identify when or if there is a bias in the Department of Health that is inconsistent with the direction of the legislative body. 

The second section provides an Overview of the Proceedings.  We suggest a change on the last line of the third paragraph to read:  “On December 21, 2007, the Department of Health distributed a draft report to participants and interested parties for review, followed by a ten-day rebuttal period to comment on the draft report.”  Rationale:  this provides the date of the draft.

The third section provides the Summary of Information.  It is in the fourth sub-section that is inaccurate in its reflection of the record.  The Sub-Section entitled Colon Hydrotherapy a Medical Practice, second paragraph, “ The practice of colon hydrotherapy is recognized in Washington as an instrumentality to diagnose and treat medical conditions.”  This statement is inaccurate and misleads the legislative body by referring to the State v. Pacific Health Center, Inc., as the rationale for colon hydrotherapy being the practice of medicine.  That case was not about colon hydrotherapy, but was about an individual that held themselves out as healing medical conditions using Electrodermal Testing (EDT), not colon hydrotherapy.

There is no similarity between the two modalities. 

In the next sentence, the Department of Health states, “Medical procedures may be performed only by an appropriately licensed health professional acting within the scope of his or her license.  In Washington, colonic irrigation is within the statutory scope of practice for naturopaths, physicians, and osteopathic physicians.”  This statement is not factual.  This is an interpretation that shows the bias of the Department of Health.  There are no laws that specifically delineate colon hydrotherapy in the scope of practice of any of those professions.  The fact is that there is not a single medical school or naturopathic school in Washington that trains naturopaths, physicians, and osteopathic physicians that provides training in colon hydrotherapy.

The next lines continue to reflect the Department of Health’s bias and interpretation as they state, “These practitioners may delegate colon hydrotherapy to other practitioners under limited circumstances.  When delegated, colon hydrotherapy must be in the scope of practice and training of the licensee performing the task.”  There are no laws that list the services that naturopaths, physicians, and osteopathic physicians may delegate, nor are there any laws that direct to whom it may be delegated.  This is an interpretation of the Department of Health and is not consistent with current practice. 

To make the point, currently, there are other class II medical devices that are routinely prescribed for patient use and that is the use of Oxygen.  Patients with pulmonary or heat issues are routinely prescribed oxygen.  The licensed practitioner writes the prescription, and the patient takes the prescription to a medical supply company where they are taught how to use the equipment, the patient then takes the equipment home and uses it when necessary.  There is no requirement for another licensee to administer the oxygen.

The records of the Sunrise Hearing clearly establish that the therapist should have a prescription from an individual licensed by the state to purchase colon hydrotherapy equipment and supplies, however, the public was very clear that they do not want to have to get prescriptions for the procedure.  In Florida, where the state certifies colon hydrotherapist, there is no requirement for prescriptions to purchase the equipment or to provide the service to the customer.

It is this interpretation by the Department of Health that screams for the legislative body to certify colon hydrotherapists.  If the legislative body does not provide certification, then the result may be that the public is deprived of access to colon hydrotherapy, or they will be forced to go to a practitioner that may not be properly trained.

The last paragraph of this sub-section.  For accuracy, the second line should read: “Under FDA regulations, colonic irrigation equipment is considered to be a class II medical device.”  Rationale:  accuracy, as the FDA does not use the term colon hydrotherapy.

Under the section “Safety and Efficacy”, third paragraph, second and third sentence, the Department of Health states, “Frequent treatments can result in the absorption of too much water.  This can lead to electrolyte imbalances in the blood, nausea, vomiting, heart failure, fluid in the lungs, abnormal heart rhythms, or coma.”  This statement is not accurate as reflected in the Serum Electrolyte Study provided.  The study showed that no patients experienced any clinically significant complications or complaints during or after the course of treatment.  The only problem might be encountered with paraplegics that are unable to completely release their bowels.

The last line of this sub-section, “Death and serious injury have been associated with colon hydrotherapy treatment without physician involvement.” is also misleading.  The information we provided was from a report in New England Journal of Medicine,

August 5, 1982, that there was a spread of amebiasis due to improperly cleaned equipment.  It was the amebiasis that lead to the deaths, not the colon hydrotherapy session.  This would not happen with appropriately trained therapists using state of the art colon hydrotherapy equipment as registered with the FDA, and disposable speculums/rectal tubes.

There have been no other documented and verified cases of death as a result of colon hydrotherapy.

In the section Findings:, we contend that colon hydrotherapy is not the practice of medicine.  The colon hydrotherapist receives a prescription from a licensed practitioner, and the writing of the prescription is the practice of medicine.  The colon hydrotherapist is following the directions of the licensed practitioner.

The next to the last section Review of Sunrise Criteria, under the sub section, First Criterion Unregulated practice can harm or endanger health and safety,  there are errors that need correction in each paragraph.

The first paragraph under the sub section, First Criterion Unregulated practice can harm or endanger health and safety,  third sentence, “Patient injury or death may also occur from frequent treatments.”  Is not accurate.  There is no basis for that statement, in fact, it is in direct conflict with the study that was provided which found, “In spite of the considerable duration of treatment and volume of water used in our study, the subjects experienced none of the symptoms of water intoxication.”

The first paragraph under the sub section, First Criterion Unregulated practice can harm or endanger health and safety,  last sentence, “Injuries and death from colon hydrotherapy have been documented.”   This is misleading and should reflect that the death was from the spread of amebiasis, and that was the cause of death, not the colonic.

The second paragraph under the sub section, First Criterion Unregulated practice can harm or endanger health and safety, last sentence, “Regulation for the health professionals who administer the treatment is appropriate and necessary to protect patient health and safety.”   This statement requires that the legislative body support the bill and provide certification for colon hydrotherapists “to protect the public” and is in direct conflict with the final recommendation of the Department of Health.

The third paragraph under the sub section, First Criterion Unregulated practice can harm or endanger health and safety,  “Colon hydrotherapy is already regulated in Washington because it is the practice of medicine.  It is within the scope of practice of physicians, osteopaths, and naturopaths.  These professionals may delegate the task to other personnel if the delegatee is properly trained and has colon hydrotherapy within his or her scope of practice.”  This was addressed earlier as it reflects the bias of the Department of Health.  No medical school or naturopathic school in WA trains or teaches about colon hydrotherapy.  Without legislation, there are no laws that preclude the practitioner from using equipment not registered with the FDA, and since the professional may delegate the task, then colon hydrotherapists must be registered or certified to perform the task.  Colon hydrotheraists are the only ones that are trained and skilled in the procedure.

The fourth paragraph under the sub section, First Criterion Unregulated practice can harm or endanger health and safety,  “The department concludes, therefore, that unregulated practice of the single procedure proposed for this profession can harm or endanger health and safety.  This conclusion, however, does not support the need to regulate colon hydrotherapists as an independent profession.  Professionals already regulated in Washington can provide this treatment.”  This paragraph, once again, cries for the legislative body to certify the colon hydrotherapists.  The Department of Health continues to contend that there are professionals in WA that can provide the treatment yet the only individuals that have been trained in colon hydrotherapy are unregulated colon hydrotherapists.  The Department of Health has made the case that colon hydrotherapists need to be regulated under the first criterion, yet they continue to deny that fact. 

The Second criterion:  Public needs will benefit from an assurance of professional ability, can only be guaranteed by recommending the legislative body regulate colon hydrotherapists, yet the draft report continues to maintain that a currently licensed practitioner that may or may not have received any training is superior to a regulated profession that guarantees the therapists are trained and regulated.  Regulation can guarantee that the practitioners are using FDA registered equipment and disposable speculums/rectal tubes.  The department concludes the Sunrise Review does not satisfy the second Sunrise criterion, yet the exact opposite is true.  The Sunrise Review showed that Public needs will benefit from an assurance of professional ability which includes appropriate training.

The Third criterion: Public protection cannot be met by other means in a cost-effective manner, has the same problem as the Department of Health continues to contend that, “the scope of practice for the proposed profession is already regulated by other professions with established programs administered through the Department of Health.  There are, therefore, other more cost effective means for providing public protection.”  Yet the fact is that the current professions do not have any required training for colon hydrotherapy in any schools and the only way the legislative body can ensure that individuals that perform this valuable service are properly trained is through certification or regulation by law.

The Conclusion the department reaches is that the Sunrise Review did meet the first Sunrise criterion.  Yet the draft states, “However, this criterion does not support regulation of the profession because the practice of colon hydrotherapy is already regulated in Washington.”  This interpretation of current regulations is not consistent with current practices and the testimony received by the Sunrise Review process.  Dr. Jacob Kornberg, Surgeon/MD provided testimony at the Sunrise Review hearing that colon hydrotherapy is not the practice of medicine and that an I-ACT certified colon hydrotherapist should be permitted to perform these services without MD supervision or further medical training.  The testimony clearly shows that there are highly trained and highly skilled colon hydrotherapists that perform this service to the public.  Testimony also showed that the public definitely wants to have this service available to them.  Testimony showed there are no medical or naturopathic schools in Washington that train colon hydrotherapy.  The only possible conclusion should be to recommend legislation.

Finally the Recommendation of the department was that the “legislature should not adopt the proposed bill establishing certification for colon hydrotherapists.” as the proposal did not satisfy the three Sunrise criteria.  Yet, in their Conclusion, the department did find that the first Sunrise criterion had been met.

Bottom line:  Throughout this draft, the department has attempted to interpret that colon hydrotherapy is in the scope of practice for naturopaths, physicians, and osteopathic physicians, yet there is no training available in any Washington medical school or naturopathic school that provides training on colon hydrotherapy.  The colon hydrotherapists that came forward during the Sunrise Review have been appropriately trained and are using FDA registered equipment. 

The Sunrise Process has determined a need for certification for this profession.  The draft and the department should resoundingly recommend the legislature support the bill and enact regulation to certify colon hydrotherapists.

If you have any questions on this response, please feel free to contact me at 210-366-2888.

Thank you for the time to submit our response and have a great day.

Sincerely,

A. R. "Dick" Hoenninger, N.D., Ph.D.

I-ACT Executive Director

11103 San Pedro, Suite 117

San Antonio, TX 78216

Phone: 210-366-2888

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