Welcome to Dr. Armand Rossi`s email newsletter:     Kid`s Unlimited

November 10, 2004

This newsletter has been assembled quickly because of time-sensitive material in it.  There are some articles that you need to read and act on.  Once more, certain groups within our profession are trying to force other members to practice "their way".  Read on.....

The following is from Kirk Erickson and Chris Kent.

Hello everyone,
   
    Please respond this week to the message below. This will impact our future as upper cervical doctors if our work is not able to be taught in any chiropractic college. The state boards will then be able to come after us for practicing what is not taught in a CCE school (this is already happening). Insurance companies will not have to pay for your patients` care. It is your choice to stand up and fight for your rights to practice subluxation-based care. Below Dr. Kent`s message is his reply that you can glean some information. Thanks for your help.
 
Kirk
 
Kirk--
 
It has recently been brought to my attention that a proposed change in the CCE Standards would limit the teaching of x-ray subjects to DACBRs or radiology residents.  Please see the fourth item on the second page:  http://www.cce-usa.org/SUMMARY%20OF%20REVISIONS.pdf
 
Comments are being accepted, and are due by November 15, 2004.  See:
http://www.cce-usa.org/2004-10-15%20Public%20Announcement.pdf
 
If implemented, this rule could prohibit upper cervical practitioners and others who are not DACBRs or radiology residents from teaching x-ray interpretation.
 
There is little doubt in my mind that this is being done, in part, to stifle the proliferation of biomechanical x-ray analysis for subluxation assessment.
 
Few DACBRs are familiar with the relevant literature, and many disparage such procedures.
 
If, after reading the proposal, you agree that this provision should be defeated, please contact your doctors by e-mail and encourage them to make a timely response.
 
Christopher Kent
 
Kirk--
 
CCE only gives 30 days notice.  These proposals appear on their web site.  I have not seen any announcements in the chiropractic press.  I suspect they are hoping they slip through unnoticed.
 
They are also attempting to mandate the teaching of "physiological therapeutics."
 
I`m attaching my letter.  Feel free to distribute it as a sample, or modify to suit.  Time is of the essence.
 
Christopher
 

TO:  Martha S. O’Connor, Ph.D., Executive Vice President, CCE

FROM: 

RE:  Public comments on proposals

 

Dear Dr. O’Connor;

 

This letter is in response to the open comment period on proposal changes to the Standards  posted on your web site:

 

  1. Sec. 2.III.C.2 Page 17 and Sec. 2.III.C2.Page 17 (Physiological Therapeutics and non-adjustive therapeutic procedures).

 

I strongly oppose any mandate to include physiotherapy or non-adjustive therapeutic procedures in accredited Doctor of Chiropractic programs.  The decision to include or exclude instruction in such subjects should be discretionary. 

 

A.     Issues of philosophy and institutional autonomy

 

Standards for Doctor of Chiropractic Programs and Requirements for Institutional Status (January 2004—Page v) state, inter alia, “The CCE does not seek to define or support any philosophy regarding the practice of chiropractic, nor are the CCE Standards intended to support or accommodate any philosophical position.  These are the responsibility of the profession and each educational DCP, giving consideration to the requirements of the jurisdiction within which the professional may practice, professional associations, and in the final analysis, the practitioner’s own philosophy of chiropractic.”

 

The decision to teach or not to teach courses in physiological therapeutics or non-adjustive therapeutic procedures goes to the heart of the philosophical division in the chiropractic profession.  It is a philosophical decision, determined by the mission and objectives of the institution.  It is not an issue of educational quality.  Teaching such courses should not be mandatory for CCE accreditation.

 

Of course, if an institution elects to offer such courses, either as part of the DCP or as electives, it is reasonable to prescribe standards that address quality of instruction and adequacy of clinical training in these subjects.

 

B.     Legal issues

 

The use of adjunctive procedures is regulated by state law.  The use of procedures outside the state scope of practice may result in charges of engaging in the unauthorized practice of medicine, and tort liability. 

For example, In Treptau v. Beherens Spa, Inc., 20 N.W.2d 108, 247 Wis.438, a chiropractor undertook to examine and treat a patient`s foot using bandages and diathermy. The Wisconsin Supreme Court stated, "Plaintiffs do not claim there was malpractice on the part of the defendant while Beherens was engaged in the practice of chiropracty (sic) by chiropractic manipulation or adjustments of the spine. Instead, plaintiffs contend there was malpractice when he and his associates went beyond the practice of chiropracty (sic) and entered into the general field of the practice of medicine...in so far as there was thus an invasion of the general field of that practice, the methods thus used by defendant`s employees in diagnosis and treatment were subject to the rules applicable to the practice of medicine and surgery."

The court in Treptau relied on Kuechler v. Volgmann, 192 N.W. 1015, 180 Wis. 238, 242-43. The Kuechler court held, "When a chiropractor assumes to diagnose and treat disease he must exercise the care and skill in so doing that is usually exercised by a recognized school of the medical profession."

While the use of physiotherapy may be lawful in some jurisdictions, the scope of such authority varies.  Furthermore, some jurisdictions prohibit their use by chiropractors.

Of equal importance is the fact that a growing body of scientific literature reports that passive physical modalities are of little or no value in addressing musculoskeletal pain, and may actually prolong disability.

While a review of the relevant literature is beyond the scope of this letter, the following papers illustrate the trend:

Van den Hoogen et al published the results of a study involving 269 patients. The objective of these investigators was to identify prognostic indicators of the duration of low back pain in general practice, and the occurrence of a relapse. It was concluded that receiving physical therapy was associated with a longer duration of low back pain.

The authors reported, "at every moment in time, patients receiving physical therapy had a 61% less chance to recover in the following week than patients not receiving physical therapy." (1)

Clinical Guidelines for the Management of Acute Low Back Pain, produced by the Royal College of General Practitioners in Great Britain, address the appropriateness of physical agents and modalities.

The Guidelines state that, "Although commonly used for symptomatic relief, these passive modalities do not appear to have any effect on clinical outcomes." The modalities listed in the Guidelines include ice, heat, short wave diathermy, massage, and ultrasound.

In reference to bed rest and traction, "Traction does not appear to be effective for low back pain or radiculopathy. ... The evidence shows that bed rest with traction is ineffective. It adds the complications of immobilsation to the deleterious effects of bed rest."

Furthermore, "There is no evidence that manipulation under general anesthesia is effective. It is associated with an increased risk of neurological damage." (2)

The AHCPR Guideline for Acute Low Back Problems in Adults concurs: "The use of physical agents and modalities in the treatment of acute low back problems is of insufficiently proven benefit to justify their cost.

"...Only two studies evaluated physical agents and modalities in patients with acute low back pain. Neither found significant differences in self-rated pain relief or other outcome measures between patient groups receiving physical agents and modalities (including diathermy, ultrasound, flexion/extension exercises, massage, and electrotherapy) and groups receiving a placebo." (3)

Concerning TENS for pain control, a study of 324 patients found no differences in outcomes in those receiving three different types of TENS and those given a sham TENS unit with indicator lights but no output. (4)

Regarding ultrasound,  Gam and Johannsen reviewed 293 papers published since 1950 to assess the evidence of effect of ultrasound for musculoskeletal disorders. Serious methodological problems existed in many of the papers. However, in 13 cases data were presented in a way that made pooling possible. The conclusion: "None of the methods gave evidence that pain relief could be achieved by ultrasound treatment." (5)

Another meta-analysis looked at 400 randomized clinical trials. Meta-analyses were performed for disorders of the back, neck, shoulder and knee. Results indicated that, "In general, the methodological quality of the studies appeared to be low, and the efficacy of physiotherapy was shown to be convincing for only a few indications and treatments." (6)

A controlled study was performed comparing osteopathic manipulation and short-wave diathermy in the treatment of non-specific low back pain The placebo group, which received fake diathermy, did about as well as those receiving real diathermy or osteopathy. The authors stated, "Benefits obtained with osteopathy and short-wave diathermy in this study may have been achieved through a placebo effect." (7)

In a study comparing drug therapy, conservative physiotherapy and manipulative physiotherapy, "Serial assessments of pain and spinal mobility showed similar response rates in all three treatment groups and no significant difference between therapies." (8)

If CCE purports to encourage evidence-based practice, mandating the instruction or use of such modalities is disingenuous, and not in the interests of the profession or the patients it serves.

C.     Recommendation

Do not implement the proposed revisions to Sec. 2.III.C.2 Page 17 and Sec. 2.III.C2.Page 17.

 

2.       Sec.2.III.E.1.b. Pages 18-19 and Sec.III.E.1.b. Page 19.  Qualifications for persons teaching courses in diagnostic imaging.

I strongly oppose a mandate that only DACBRs and residents in approved radiology residencies may teach diagnostic imaging courses.  There are several reasons for this.

A.     Other imaging specialists are qualified to teach such courses

I have no objection to requiring persons teaching radiology courses to have appropriate training.  However, it is improper to grant a monopoly to DACBRs and radiology residents seeking DACBR status.

For example, in addition to DACBRs, there are Diplomates of the ICA College of Chiropractic Imaging who have completed a minimum of 300 hours of postgraduate training in diagnostic imaging, and passed comprehensive written and practical examinations.  Several such Diplomates have taught radiology courses in CCE accredited colleges. 

Several chiropractic colleges offer or have offered postgraduate certification courses in specialized imaging techniques, such as videofluoroscopy.

Some chiropractors have completed postgraduate courses, such as visiting fellowship programs, in advanced imaging techniques such as magnetic resonance imaging.

Courses in imaging physics and technology may be effectively taught by physicists specializing in diagnostic imaging, or radiologic technologists.

Although the proposed revision to Sec.III.E.1.b. Page 19 permits medical radiologists to teach imaging courses, Sec.2.III.E.1.b. Pages 18-19 does not.

Some institutions offer courses that include integrated clinical, laboratory, and imaging instruction.  There are also courses which deal with radiological interpretation as related to biomechanical, subluxation analysis and chiropractic technique.  Such individuals frequently have postgraduate training in specific chiropractic techniques.  DACBRs often lack training and experience in specific systems of spinographic analysis, despite expertise in general radiology.

B.     Philosophy and institutional autonomy

As stated in 1. supra, Standards for Doctor of Chiropractic Programs and Requirements for Institutional Status (January 2004—Page v) state, inter alia, “The CCE does not seek to define or support any philosophy regarding the practice of chiropractic, nor are the CCE Standards intended to support or accommodate any philosophical position.  These are the responsibility of the profession and each educational DCP, giving consideration to the requirements of the jurisdiction within which the professional may practice, professional associations, and in the final analysis, the practitioner’s own philosophy of chiropractic.”

C.     Recommendation

Do not implement proposed revision to Sec.2.III.E.1.b. Pages 18-19.  Change the wording on Sec.III.E.1.b. Page 19 to read as follows:

(4) All radiology courses, including radiological anatomy and x-ray positioning, should be taught by individuals with specific credentialing in the radiology course(s) in which they serve as faculty.

 

Thank you for your kind consideration.

 

Sincerely,

 

REFERENCES

1. van den Hoogen HJM, Koes BW, Deville W, et al: "The prognosis of low back pain in general practice." Spine 1997;22(13):1515.

2. Clinical Guidelines for the Management of Acute Low Back Pain. Royal College of General Practitioners. September, 1996. Available at http://www.rcgp.org.uk

3. "Clinical Practice Guideline Number 14." Acute Low Back Problems in Adults. Agency for Health Care Policy and Research. December 1994.

4. "No better than placebo. Another look at TENS units for low back pain." Spine Letter 1997;4(5):2.

5. Gam AN, Johannsen F: "Ultrasound therapy in musculoskeletal disorders: a meta-analysis." Pain 1995;63(1):85.

6. Beckerman H, Boulter LM, van der Heijden GJ, et al: "Efficacy of physiotherapy for musculoskeletal disorders: what can we learn from the research?" Br J Gen Pract 1993;43(367):73.

7. Gibson T, Grahame R, Harkness J, et al: "Controlled comparison of short-wave diathermy treatment with osteopathic treatment in non- specific low back pain." The Lancet 1985;1(8440):1258.

8. Waterworth RF, Hunter IA: "An open study of diflunisal, conservative and manipulative therapy in the management of acute mechanical low back pain." N Z Med J 1985;98(779):372.

 



The following is a note from Dr. Gerard Clum:

The phone number you listed in your message about the CCE proposals is

wrong. you listed 408 as the area code, it should be 480.

All of the change sproposed can be found at the CCE website at

www.cce-usa.org in addition to the offensive proposals you outlined

there are a number of others that should cause folks a considerable

amount of heartburn.

The College will be finalizing our input on 11/9/04 and I will forward

you a copy of our comments regarding these issues.

One final suggestion...a letter would be good, attending the meeting in

Phoenix and testifying would be even better--especially if the person

represented a defined constituent group.

Take care, thanks for the help. Be well.

Gerry


The following is from Dr. Don Harrison:
Dear Doctor,
Please download my attached letter as a template for your own and then FAX it to this Executive VP Dr. O`Connor at the CCE

FAX: 1-480-483-7333.

Sincerly,

 
Don Harrison, PhD, DC, MSE

 


 

Donald D. Harrison, PhD, DC, MSE

CBP Non Profit, Inc.

PO BOX 1590

Evanston, WY 82931

Ph: 307-789-2088

 

Martha S. OConnor, PhD                                                                  November 8, 2004

Executive Vice-Pres.

CCE

8049 W. 85th Way

Scottsdale, AZ 85258-4321

FAX: 1-480-483-7333

 

RE:  Comments needed by Nov 15th on Proposed Revisions of CCE Standards per CCE    

        Policy BOD-22, specifically Lecturers for Radiology Courses in Chiropractic 

        Colleges.

 

Dear Dr. OConnor:

            I was very surprised to see an obvious conflict of Standards in your new Proposed Revisions for CCE Standards. Specifically pages 18 and 19, Sec. 2.111.E.1.a&b. See copy below:

              All chiropractors have the same education in radiographic anatomy, imaging physics, and x-ray positioning. All chiropractors are licensed by all State Boards to determine the need for x-rays, taking of x-rays (including positioning, shielding, machine factors of MAS & KV, processing of films), interpretation of films, and geometric analysis of the bony structures.

            In fact, in most States, whether by licensure or by in-office training, CAs (Chiropractic Assistants) may position the public for x-rays, determine the penetrating factors, take the x-rays, and develop the x-rays.

            To designate a DACBR or DACBR trainee as the only persons certified to teach these items in Chiropractic Colleges is absurd and directly in conflict with existing State Laws.

            DACBRs are NOT trained in Universities with a degree in such topics. They have a few extra weekends of rehashing what all DCs learned about x-ray projection, x-ray positioning, and x-ray physics. A DACBRs extra training is confined to looking at radiographic contours (hard tissue and soft tissue) for abnormalities. This training is NOT in x-ray physics, nor projection, nor positioning. In fact, I have had a lot of university courses/degrees in mathematics, physics, and mechanical engineering. I have had graduate courses in Projection Geometry; I have exact knowledge that DACBRs are NOT trained in these fields above any other graduated DC.

            I have had past debates in JMPT with DACBRs on these exact topics, see (1) DG Hariman JMPT 1995; 18(5): 323-324 and (2) DD Harrison et al. JMPT 1995; 18(5): 324-325. Whenever a DACBR gets out of the realm of radiological contours (normal and abnormal), they step totally out of their field into other fields in which they have absolutely NO education and NO expertise.

            I have personally published studies, which have shown that many long-time held DACBR OPINIONS are false; these false opinions have been perpetuated in Chiropractic Colleges for at least 3 decades. These false opinions, held by all DACBRs, point to the inadequacies in the DACBR weekend certification courses. Such courses are absolutely NOT equivalent to a university education. If such topics were taught in a University and not by DACBRs, such false information would not be perpetuated. Some of these false opinions are:

1. Normal spinal position does not exist,

2. Variations in x-ray positioning simulate subluxation or correction,

3. Posture and biomechanical analysis are not repeatable phenomena,

4. slight head nodding/flexion creates kyphosis in the cervical spine,

5. acute muscle spasms cause cervical and lumbar kyphosis or hypo-lordosis,

            6. normal anatomic variants cause the spine to appear to be subluxated,

            7. x-rays should not be taken for biomechanical or postural screening and post x-

    rays are not warranted, and

            8. radiographic line drawing for measuring spinal displacements are not reliable.

 

Contrary to DACBR personal opinions (#1-#8 above), the following references show some of the facts:

1. Harrison DD, Troyanovich SJ, Harrison DE, Janik TJ, Murphy DJ.  A Normal Sagittal

    Spinal Configuration: A Desirable Clinical Outcome. J Manipulative Physiol Ther

    1996; 19(6):398-405.

2. Harrison DD, Janik TJ, Troyanovich SJ, Holland B.  Comparisons of Lordotic

   Cervical Spine Curvatures to a Theoretical Ideal Model of the Static Sagittal Cervical

    Spine.  Spine 1996;21(6):667-675.

3. Harrison DD, Janik TJ, Troyanovich SJ, Harrison DE, Colloca CJ. Evaluations of the

     Assumptions Used to Derive an Ideal Normal Cervical Spine Model.  J Manipulative

     Physiol Ther 1997;20(4): 246-256.

4. Troyanovich SJ, Cailliet R, Janik TJ, Harrison DD, Harrison DE.   Radiographic

    Mensuration Characteristics of the Sagittal Lumbar Spine From A Normal Population

    with a Method to Synthesize Prior Studies of  Lordosis. J Spinal Disord 1997;10(5):

    380-386.

5. Harrison DD, Cailliet R, Janik TJ, Troyanovich SJ, Harrison DE, Holland B. Elliptical   

      Modeling of the  Sagittal Lumbar Lordosis and Segmental Rotation Angles as a Method to  

     Discriminate Between Normal and Low Back Pain Subjects.  J Spinal Disord 1998; 11(5): 

      430-439.

6.   Janik TJ, Harrison DD, Cailliet R, Troyanovich SJ, Harrison DE. Can the Sagittal Lumbar

      Curvature be Closely Approximated by an Ellipse? J Orthop Res 1998; 16(6):766-70.

7.   Harrison DE, Janik TJ, Harrison DD, Cailliet R, Harmon S. Can the Thoracic Kyphosis be

Modeled with a Simple Geometric Shape? The Results of Circular and Elliptical Modeling in 80 Asymptomatic Subjects. J Spinal Disord Tech 2002; 15(3): 213-220.

8.  Harrison DD, Harrison DE, Janik TJ, Cailliet R, Haas JW. Do Alterations in Vertebral

      and Disc Dimensions Affect an Elliptical Model of the Thoracic Kyphosis? Spine 2003;

       28(5): 463-469.

9.   Harrison DD, Harrison DE, Janik TJ, Cailliet R, Haas JW, Ferrantelli J, Holland B.

      Modeling of the Sagittal Cervical Spine as a Method to Discriminate Hypo-Lordosis:  

      Results of Elliptical and Circular Modeling in 72 Asymptomatic Subjects, 52 Acute Neck

      Pain Subjects, and 70 Chronic Neck Pain Subjects. Spine 2004; 29(22): in press for Nov

     15th.

10. Harrison DE, Harrison DD, Colloca CJ, Betz J, Janik TJ, Holland B. Repeatability of

       Posture Overtime, X-ray Positioning, and X-ray Line Drawing: An Analysis of Six

       Control Groups. J Manipulative Physiol Ther 2003; 26(2): 87-98.

11. Jackson BL, Harrison DD, Robertson GA, Barker WF. Chiropractic Biophysics

     Lateral Cervical Film Analysis  Reliability. J Manipulative Physiol Ther 1993; 16(6):

     384-391.

12. Troyanovich SJ, Robertson GA, Harrison DD, Holland B.  Intra- and Interexaminer

    Reliability of the Chiropractic Biophysics Lateral Lumbar Radiographic Mensuration

    Procedure. J Manipulative Physiol Ther 1995;18(8):519-524.

13. Troyanovich SJ, Harrison DE, Harrison DD, Holland B, Janik TJ. Further Analysis of

      the Reliability of  the Posterior Tangent Lateral Lumbar Measuration Procedure: 

      Concurrent Validity of Computer Aided X-ray Digitization. J Manipulative Physiol

      Ther 1998; 21(7): 460-467

14. Troyanovich SJ, Harrison SO, Harrison DD, Harrison DE, Payne MR, Janik TJ,

      Holland B. Chiropractic Biophysics Digitized Radiographic Mensuration Analysis of

      The Anterioposterior Lumbopelvic View: A Reliability Study. J Manipulative

      Physiol Ther 1999; 22:309-315.

15. Harrison DE, Harrison DD, Cailliet R, Troyanovich SJ, Janik TJ. Cobb Method or

      Harrison Posterior Tangent Method: Which is Better for Lateral Cervical Analysis? 

      Spine 2000; 25: 2072-78.

16. Harrison DE, Cailliet R, Harrison DD, Janik TJ, Holland B. Centroid, Cobb or Harrison

Posterior Tangents: Which to Choose for Analysis of Thoracic Kyphosis? Spine 2001; 26(11): E227-E234.

17.  Harrison DE, Harrison DD, Janik TJ, Harrison SO, Holland B. Determination of Lumbar

      Lordosis: Cobb Method, Centroidal Method, TRALL or Harrison Posterior Tangents?

      Spine 2001; 26(11): E236-E242.

18. Janik TJ, Harrison DE, Harrison, DD, Payne MR, Coleman RR, Holland B. Reliability of

      lateral bending and axial rotation with validity of a New Method to determine Axial

      Rotations on AP Radiographs. J Manipulative Physiol Ther 2001; 24(7): 445-448.

19. Harrison DE, Holland B, Harrison DD, Janik TJ.  Further Reliability Analysis of the

      Harrison Radiographic Line Drawing Methods: Crossed ICCs for Lateral Posterior

      Tangents and AP Modified Risser-Ferguson. J Manipulative Physiol Ther 2002;25:93-8.

20. Harrison DE, Harrison DD, Janik TJ, Holland B, Siskin L.  Slight Extension Head Nodding:

      Does it reverse the cervical curve? Eur Spine J  2001; 10: 149-153.

 

Important Political Component

            Requiring a political group, such as ACAs DACBRs, to be the only persons qualified to teach radiology courses in chiropractic colleges is bordering on a possible lawsuit. The Diplomats in American Chiropractic (Association) Board of Roentgenology are ACA members. DACBRs, DACBNs, DACBOs were sanctioned by the ACA in the beginning. Recently, to try to look independent, they are trying to have outside sponsorship. However, I believe it is a requirement that they have to be members of the ACA. To have a political group influencing education is a no-no in accreditation. The ICA has their counterparts in Radiology. Will they be acceptable teachers?? I think not, in the way you have worded this standard of politics.

 

            In summary, DACBRs are subject to incest learning because they continually teach themselves and other trainees without an outside influence from the literature or university setting. They are members of a political organization, ACA. To decide that only DACBRs are qualified to teach anything more than radiographic pathology courses is false.

 

Sincerely,

 

 

Donald D. Harrison, PhD (applied mathematics), DC, MSE (Mechanical Engineering)


November 10, 2004

 

To: Martha O’Connor, Ph.D.

      Executive Vice-President

      The Council on Chiropractic Education

 

From: Gerard W. Clum, D.C.

 

Re: Proposed changes to the Standards for Doctor of Chiropractic Programs and Requirements for Institutional Status

 

Dear Dr. O’Connor,

 

Pursuant to the “Call for public comment” relative to proposed changes[1] in the Standards noted above I offer the following input:

 

Standards, Section 2, III., B., 2, page 16 and Standards, Section 2, IV., C. page 48:

 

“If the DCP is a part of an institution offering other programs, the governing board of the institution housing the program must have adopted and follow policies to assure that the members of the governing board do not have any real or perceived conflict between their personal interests and the best interest of the institution, its programs and affiliated entities, and no member of the governing board may be a member of the board or administrative staff of another program/institution accredited by the COA.

Any member of the governing board with a conflict of interest must be removed promptly and will not be eligible to serve on the governing board until one year after the conflict of interest is resolved.”

 

“d. Any member of the governing board with a conflict of interest must be removed promptly and will not be eligible to serve on the governing board until one year after the conflict of interest is resolved.”

 

The issue of “perceived” conflict of interest is an ambiguous matter and not a matter that is subject to clear and uniform application or interpretation. The language of the change leaves it open to many questions, for example:

1. Does the requirement imply a perceived conflict on the part of a member of the governing board, on the part of a majority of the governing board, on the part of the Commission on Accreditation, on the part of a member of the profession or on the part of a member of the general public?

 

2. Many institutions enjoy the services as members of their governing board of persons who are affiliated with banking institutions that are used by the institution. This provision would seem to eliminate the possibility of service to the institution by such persons.

 

3. Further, these provisions do not contemplate a conflict of interest that is disclosed to the other members of the Board and the use of safeguards to assure that the governing board members restrict their authority in matters related to the conflict. Rather these provisions eliminate such persons from any service to the institution. These provisions will not add clarity to the Standards and could serve to be used to unnecessarily and inappropriately limit the service of experienced and dedicated persons to accredited institutions and programs.

 

We request the rejection of these proposals by the Board of Directors of the CCE.

 

Standards, Section 2., III., C., 2, page 17:

 

“The curriculum required for the DCP must include the following subjects (not necessarily in individual courses for each subject): anatomy; …adjustive techniques; non-adjustive therapeutic procedures;”

 

The term “non-adjustive therapeutic procedures” is so broad it renders any meaningful interpretation and application impossible. For example, is an abortion a “non-adjustive therapeutic procedure”? The inclusion of this provision opens the content of a Doctor of Chiropractic curriculum to anything and everything in the universe of health of health care in addition to adjustive procedures.

 

This is an illogical and an irresponsible change in the Standards.

 

We request the rejection of this proposal by the Board of Directors of the CCE.

 

Standards, Section 2, III., C., 2., page 17

 

“The curriculum required for the DCP must include the following subjects (not necessarily in individual courses for each subject): anatomy; biochemistry…adjustive techniques; physiological therapeutics;…”

 

The issue of inclusion of physiological therapeutics as a required course within a Doctor of Chiropractic curriculum is an unnecessary and unwarranted intrusion into the decision-making of Doctor of Chiropractic degree programs and institutions.

 

The CCE has long held that it does not dictate a philosophical perspective with respect to the discipline of chiropractic. The inclusion of this requirement contradicts such an assertion.

 

In the past the argument has been offered that this change was needed by selected boards of chiropractic examiners across the country. With all due respect to those boards, their administrative needs are NOT a reason to change educational requirements and/or clinical competency requirements.

 

The current optional nature of the subject matter is adequate for the boards and for the institutions. If an institution or program chooses not to offer the subject matter under consideration and so advises its students of the potential for limitations in licensure upon completion of that institution’s degree program then the matter has been disclosed and addressed appropriately.

 

The inclusion of this requirement will serve to further fractionalize the educational community of the profession. It will not add anything meaningful to the curriculum offered by any program or institution and will start the CCE down a slippery slope of curriculum mandates as to the extent of clinical interventions an institution must present within its program. As the National Board of Chiropractic Examiners now offers an acupuncture examination and various boards allow for such procedures the inclusion of this subject matter, against the desire and will of institutions, must logically be appreciated as being around the corner.

 

We request the rejection of this unnecessary and damaging proposal by the Board of Directors of the CCE.

 

Standards, Section 2., III., B., 4., g., page 17

 

“The disclosure of graduation rates, federal Title IV loan default rates, student performance on national board examinations, any available data on placement rates and success of program graduates in obtaining jurisdictional licensure, must occur in written (catalog and/or insert) or electronic form (institutional web pages) on October 1, annually. Graduation rates, Title IV default rates, and NBCE pass rates may be discloses, by date, for the entire annual period, or may be disclosed as a cumulative average (and weighted for NBCE pass rates) for a two-year period using the current year as the second of the two cumulative years.”

 

There are a number of problems with the proposed changes reflected above. In certain situations (Title IV default rates for example) the data involved is not available on October 1 of any given year. This proposal would allow the data received after October 1 to be delayed in posting until October 1 of the following year.

 

The proposed changes in the method of reporting NBCE pass rates will promote greater confusion and manipulation of the data to reflect the best view of the institution/program as opposed to a consistent and comparable view of the program or institution.

 

We request the rejection of this proposal by the Board of Directors of the CCE.

 

Standards, Section 2, III., E., 1., b., page 18-19 and Standards, Section 2., III., E., 4., page 19

 

“(2) Each person teaching radiology courses, to include radiographic anatomy, radiological interpretation and imaging physics, must be certified chiropractic radiologists or radiology residents (be in an approved residency program seeking such certification). These persons should meet all other CCE requirements for faculty positions in addition to holding diplomate status of the American Chiropractic Board of Radiology (DACBR).

 

(4) All radiology courses, including radiological anatomy and x-ray positioning, should be taught by instructors with specific credentialing in Radiology such as a Chiropractic Radiologist (DACBR) or a Medical Radiologist (DABR), rather than any chiropractor.”

 

The proposals outlined above serve only the needs of the American Board of Chiropractic Radiology and its Diplomates. This is an unnecessary and inappropriate intrusion into the faculty selection and assignment rights and authorities of the programs and institutions. This provision limits qualified persons who are not Diplomates of the American Board of Chiropractic Radiology from providing instruction in chiropractic degree programs.

 

This is an unprecedented faculty requirement within the Standards of the CCE. It does not serve the institutions or students impacted. This provision would essentially cause the institutions and programs of the CCE to be held hostage by the Diplomates of the American Board of Chiropractic Radiology with respect to salaries and teaching assignments.

 

The phrase “…rather than any chiropractor.” Is insulting to all chiropractors in its tone and intent.

 

We request the rejection of this proposal by the Board of Directors of the CCE.

 

Standards, Section III., E., 4., (new) page 19

 

“The DCP must comply with the 1940 Statement of Principles on Academic Freedom and Tenure and the 1970 Interpretive Comments by the American Association of University Professors. (SEE ATCH 6)”

 

We request the rejection of this proposal by the Board of Directors of the CCE.

 

 

 

Standards, Section III., F., 1., e., (new), page 20

 

“e. All matriculants to the DCP must submit to a criminal background check as part of their fitness assessment to enter the chiropractic profession.”

 

This is an unwarranted and unenforceable requirement of matriculants-not institutions or programs. If a student refuses such a background check after admission to a program or institution are they to be dismissed?

 

This provision appears to be the work of the licensing community and seeks to defer some of their duties to the institutions. Once admitted, institutions would be left to determine what type of offense would cause a person to be unfit for the profession. These determinations may or may not match the determination of examining boards at the time of licensure. This situation would then accrue tremendous liability for programs and institutions as it would be argued that the background check was to assure the students ultimate “fitness” for entry into the profession. Or, the student not admitted under this requirement, would argue that the institution or program inappropriately denied them the opportunity to pursue a career.

 

This is a dangerous provision fraught with liability that seeks to have the institutions and programs resolve matters that are the jurisdiction of boards of examiners. The provision would begin to have some meaning if the respective boards agreed to accept the judgment of the institutions or programs with respect to past history

 

We request the rejection of this proposal by the Board of Directors of the CCE.



[1] Text in black in the Arial font is existing in the CCE Standards, text in red in the Arial font is a proposed change in the Standards,  text in New Times Roman is the feedback and commentary of the author of this memorandum


Failing the Public Health — Rofecoxib, Merck, and the FDA
Eric J. Topol, M.D.

 
On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.

Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its responsibilities to the public. The pivotal trial for rofecoxib involved 8076 patients with rheumatoid arthritis and demonstrated that this coxib had lower gastrointestinal toxicity than naproxen.1 Even though the drug was approved in 1999 on the basis of data submitted to the FDA, the data were not submitted to a peer-reviewed journal until the following year and did not appear in print until November 23, 2000, one and a half years after commercial approval had been granted. The cardiovascular data reported in that article were incomplete, in part because of incomplete ascertainment: the design and execution of the trial had not anticipated that untoward cardiovascular events might occur.1

It was not until February 8, 2001, that the FDA Arthritis Advisory Committee met to discuss concern about the potential cardiovascular risks associated with rofecoxib. It remains unclear why the FDA waited two years after its review and approval of rofecoxib to conduct this meeting. My colleagues and I reviewed the data from the meeting that were made publicly accessible and published an analysis of all the available data on rofecoxib and celecoxib on August 22, 2001.2 Our primary conclusion, based on the clear-cut excess number of myocardial infarctions associated with rofecoxib and the numerical, albeit not statistically significant, excess associated with celecoxib, was that "it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents."2 Such a trial needed to be conducted in patients with established coronary artery disease, who frequently have coexisting osteoarthritis requiring medication and have the highest risk of further cardiovascular events. Given the very high coincidence of coronary disease and arthritis, this group may represent the largest segment of the population for whom rofecoxib was prescribed. In light of the insight that arterial inflammation is the basis for myocardial infarction and stroke and the knowledge that coxibs reduce the production of biomarkers of inflammation such as C-reactive protein and improve endothelial function, such a trial would also have been quite attractive from the standpoint of potential benefit. The trial would have prospectively determined the incidence of cardiovascular events, whose possible association with coxib treatment had not been anticipated in the early and pivotal trials of these drugs.

Unfortunately, such a trial was never done. The FDA has the authority to mandate that a trial be conducted, but it never took the initiative. Instead of conducting such a trial at any point — and especially after the FDA advisory committee meeting in 2001 — Merck issued a relentless series of publications, beginning with a press release on May 22, 2001, entitled "Merck Reconfirms Favorable Cardiovascular Safety of Vioxx" and complemented by numerous papers in peer-reviewed medical literature by Merck employees and their consultants. The company sponsored countless continuing medical "education" symposiums at national meetings in an effort to debunk the concern about adverse cardiovascular effects. The message that was duly reinforced was that rofecoxib had no cardiovascular toxicity: rather, naproxen was cardioprotective. Only by happenstance, in a trial involving 2600 patients with colon polyps who could not have been enrolled if they had had any cardiovascular disease, was it discovered that 3.5 percent of the patients assigned to rofecoxib had myocardial infarction or stroke, as compared with 1.9 percent of the patients assigned to placebo (P<0.001), necessitating premature cessation of the trial and the decision to discontinue treatment with rofecoxib.

Over the course of the five-and-a-half-year saga, many epidemiologic studies confirmed and amplified the concern about the risk of myocardial infarction and serious cardiovascular events associated with rofecoxib.3 These studies considered large populations, up to 1.4 million patients, tracking the use of various nonsteroidal antiinflammatory medications or coxibs to determine the risk of adverse events. Each time a study was presented or published, there was a predictable and repetitive response from Merck, which claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk. But if Merck would not initiate an appropriate trial and the FDA did not ask them to do so, how would the truth ever be known?

Meanwhile, Merck was spending more than $100 million per year in direct-to-consumer advertising — another activity regulated by the FDA and a critical mechanism in building the "blockbuster" status of a drug with annual sales of more than $1 billion. For the past few years, every month has seen more than 10 million prescriptions for rofecoxib written in the United States alone. At any point, the FDA could have stopped Merck from using direct-to-consumer advertising, especially given the background concern that the cardiovascular toxicity was real and was receiving considerable confirmation in multiple studies conducted by investigators who were independent of Merck. The only significant action taken by the FDA occurred on April 11, 2002, when the agency instructed Merck to include certain precautions about cardiovascular risks in its package insert. The FDA also sponsored one of the large epidemiologic studies performed in a cohort of Kaiser Permanente patients.

Considering the tens of millions of patients who were taking rofecoxib, we are dealing with an enormous public health issue. Even a fraction of a percent excess in the rate of serious cardiovascular events would translate into thousands of affected people. Given the finding in the colon-polyp trial in low-risk patients without known cardiovascular disease — an excess of 16 myocardial infarctions or strokes per 1000 patients — there may be tens of thousands of patients who have had major adverse events attributable to rofecoxib (see Figure). 

 
I believe that there should be a full Congressional review of this case. The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health. Sadly, it is clear to me that Merck`s commercial interest in rofecoxib sales exceeded its concern about the drug`s potential cardiovascular toxicity. Had the company not valued sales over safety, a suitable trial could have been initiated rapidly at a fraction of the cost of Merck`s direct-to-consumer advertising campaign. Despite the best efforts of many investigators to conduct and publish meaningful independent research concerning the cardiovascular toxicity of rofecoxib, only the FDA is given the authority to act. In my view, the FDA`s passive position of waiting for data to accrue is not acceptable, given the strong signals that there was a problem and the vast number of patients who were being exposed. Furthermore, the tradeoff here involved a drug for symptoms of arthritis, for which many alternative medications are available, in the context of serious, life-threatening cardiovascular complications. Certainly there are many facts that we are not privy to, such as the direct communication between the FDA and Merck, but all the facts can and should be scrutinized closely in a Congressional review in order to avert such a catastrophe in the future.


Source Information

From the Cleveland Clinic Foundation, Cleveland.

References

  1. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343:1520-1528.[Abstract/Full Text]
  2. Mukherjee DM, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286:954-959.[Abstract/Full Text]
  3. Topol EJ, Falk GW. A coxib a day won`t keep the doctor away. Lancet 2004;364:639-640.[CrossRef][ISI][Medline]

A Sign of the Times

Prozac

Chicken Soup for the Flu Shot Soul

Health Sciences Institute e-Alert

October 21, 2004

Dear Reader,

It`s always something. Or when it comes to the flu vaccine it seems that way. Every year there`s a new wrinkle; a feared pandemic, a run on doctors` offices that create shortages, or

Ben Maimon was a 12th century Jewish philosopher and physician who recommend this treatment for influenza and colds: chicken soup. As the story goes, Moshe drew on classical Greek medicine to support his recommendation, but I`ll bet you a dollar he actually picked it from his mom.

I was reminded of Moshe`s soup cure when I came across an Associated Press item about a flu vaccine clinic offered in Fergus Falls, Minnesota. Because of the nationwide vaccine shortage, the clinic received no supply of the vaccine at all. So when people came by to get a flu shot, they were given a can of chicken soup and a box of tissues instead.

When Kris Ehresmann, the head of Minnesota`s immunization program, heard about the soup giveaway, with some amusement she told the AP that it was, "better than nothing." Better than nothing, indeed. In fact, according to one study, chicken soup is full of good nutrition and even has natural anti-inflammatory properties. That`s much more than I can say for the flu vaccine.

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Grandma`s penicillin

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Stephen Rennard, M.D., is a researcher at the University of Nebraska where he studies the defense mechanisms of the lung. One day, while enjoying his wife`s homemade chicken soup, he wondered if something in the soup might have an anti-inflammatory effect on the respiratory viral infections responsible for colds and the flu.

From a recipe called "Grandma`s Soup," Dr. Rennard had his wife prepare several batches for laboratory tests to examine the soup`s effect on neutrophils; white blood cells that stimulate mucous release. As reported in a 2000 issue of the medical journal Chest, Dr. Rennard and his team found that the ingredients of the soup clearly inhibited the movement of neutrophils. In other words, chicken soup may actually trigger a cold and flu-fighting reaction in the body. But it doesn`t end with neutrophils inhibition.

Many chicken soup recipes call for exactly what a sick person needs: ingredients that are nutrient-rich, such as onions, carrots, celery, parsley, sweet potatoes, parsnips and turnips (all of which were included in Grandma`s Soup).

In an interview with Reuters, Dr. Rennard also acknowledged that the steam from the warm soup may help soothe inflamed sinuses. And when someone lovingly prepares the soup for you – a doting Grandma, for instance – the care itself may provide a therapeutic psychological boost that promotes healing.

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Spice it up

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Dr. Rennard`s Grandma`s Soup recipe calls for salting and peppering to taste, which is good advice. Sodium is an essential electrolyte that promotes hydration. That`s not to say that salt should be shoveled in, but adding some salt is a plus, unless your doctor has instructed you to avoid it. And don`t hold back on the pepper either. Natural medical physician Dr. Joseph Mercola suggests that plenty of pepper will help thin respiratory mucus when fluids in the mouth and throat are stimulated. He adds that the main ingredient of chicken soup – that is, of course, chicken – contains cysteine; an amino acid that also thins mucus.

So if you drop by a clinic to get a flu shot and receive soup instead, don`t think you`re getting the lesser of two treatments. With a large pot of chicken soup simmering on the stove, you just might have your healthiest flu season ever.

– as is the case this year – a vaccine manufacturer is shut down, creating scarce supplies, thefts of vaccine caches, black market sales, etc. Always something. As Moshe ben Maimon might say: It`s meshuggah.


Murphy`s Other Laws

1. Everyone has a photographic memory. Some don`t have film.

2. He who laughs last, thinks slowest.


3
. The shinbone is a device for finding furniture.


4. Change is inevitable, except from a vending machine.

5. Back up my hard drive? How do I put it in reverse?

6. I just got lost in thought. It was unfamiliar territory.

7. Light travels faster than sound. This is why some people     appear bright until you hear them speak.


8. Seen it all, done it all. Can`t remember most of it.

9. Those who live by the sword get shot by those who don`t.

10. I feel like I`m parallel parked in a diagonal universe.

11. He`s not dead, he`s electroencephalographically challenged.

12. She`s always late, in fact, her ancestors arrived on the Juneflower

13. You have the right to remain silent. Anything you say will be misquoted and used against you.

14. I wonder how much deeper the ocean would be without sponges

15. Honk if you love peace and quiet.

16. Pardon my driving, I`m reloading.

17. Despite the cost of living, have you noticed how it remains so popular?

18. It was recently discovered that research causes cancer in rats.

19. It is hard to understand how a cemetery can raise its burial costs and blame it on the higher cost of living.

20. Just remember...if the world didn`t suck, we`d all fall off.

21. The 50-50-90 rule: Anytime you have a 50-50 chance of
getting something right, there`s a 90% probability you`ll get it wrong.

22. It is said that if you line up all the cars in the
world end to end, someone would be stupid enough to try and pass them.

23. The latest survey shows that 3 out of 4 people make up 75% of the world population.

24. If the shoe fits, get another one just like it.

25. The things that come to those that wait may be the things left by those who got there first.

26. Give a man a fish and he will eat for a day. Teach a man to fish and he will sit in a boat all day drinking beer.

27. Flashlight: A case for holding dead batteries - very true...never fails

28. A fine is a tax for doing wrong. A tax is a fine for doing well.

29. When you go into court, you are putting yourself in the hands of 12 people that weren`t smart enough to get out of jury duty.


IDLE THOUGHTS OF A RETIRED PERSON...(WHOSE MIND WANDERS)

 I had amnesia once -- or twice.

 I went to San Francisco. I found someone`s heart. Now what?

 Protons have mass? I didn`t even know they were Catholic.

 All I ask is a chance to prove that money can`t make me happy.

 If the world was a logical place, men would ride horses sidesaddle.

 What is a "free" gift? Aren`t all gifts free?

 They told me I was gullible ... and I believed them.

 Teach a child to be polite and courteous in the home and, when he grows  up, he`ll never be able to merge his car onto a freeway.

 Two can live as cheaply as one, for half as long.

 Experience is the thing you have left when everything else is gone.

 What if there were no hypothetical questions?

 One nice thing about egotists: They don`t talk about other people.

 When the only tool you own is a hammer, every problem begins to look like  a nail.

 A flashlight is a case for holding dead batteries.

 What was the greatest thing before sliced bread? Hmmmm?

 My weight is perfect for my height -- which varies.

 I used to be indecisive. Now I`m not sure.

 The cost of living hasn`t affected its popularity.

 How can there be self-help "groups"?

 Is there another word for synonym?

 Where do forest rangers go to "get away from it all"?

 The speed of time is one-second per second.

 Is it possible to be totally partial?

 What`s another word for thesaurus? ( Note from me .  Several qualify.  Storehouse, lexion, treasury, encyclopedia.)

 Is Marx`s tomb a communist plot?

 If swimming is so good for your figure, how do you explain whales?

 Show me a man with both feet firmly on the ground, and I`ll show you a man who can`t get his pants off.

 It`s not an optical illusion. It just looks like one.

 Is it my imagination, or do buffalo wings taste like chicken?


Here are a list of my upcoming talks and seminars.  Please note that these may change.

November 13 - 14, 2004   Portland, Or.      ICPA  – Introduction to Chiropractic for the Family

February 19 -20, 2005     Calgary, Canada    ICPA  – Introduction to Chiropractic for the Family

March 5 - 6, 2005             Los Angeles, Ca.   ICPA  – Introduction to Chiropractic for the Family

March 12 - 13, 2005      Montreal, Canada  ICPA  – Introduction to Chiropractic for the Family

April 23 - 24, 2005         Detroit, Michigan    ICPA  – Introduction to Chiropractic for the Family

Sept. 17 - 18, 2005   Hamburg, Germany    ICPA  – Introduction to Chiropractic for the Family


This newsletter does not replace pure, principled, unadulterated chiropractic care!!!