V. RESPONSE TO THE DHHS DAB DECISION

3. Dr. Calabrese is an allergist-immunologist with a special interest in allergic hypersensitivity to chemicals. 

DHHS DAB writes:    “Dr. Calabrese specializes in the care of patients suffering from a pattern of symptoms known as severe ‘multiple chemical sensitivity syndrome.’’

The Plaintiffs respectfully disagree and respond as follows:

Mark Twain said: "The difference between the right word and the almost-right word is the difference between the lightning and the lightning bug," and he wasn’t a lawyer.  So we need to review accepted medical definitions to have a common groundwork:

chemical sensitivities – a symptom array of variable presentation attributed to recurrent exposure to known environmental chemicals at dosages generally below levels established as harmful; complaints involve multiple organ systems.  @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

symptom - any morbid phenomenon or departure from the normal in structure, function, or sensation, experienced by the patient and indicative of disease. @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

syndrome - the aggregate of symptoms and signs associated with any morbid process, and constituting together the picture of the disease. @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

diagnosis by exclusion - a diagnosis made by excluding those diseases to which only some of the patient's symptoms might belong, leaving one disease as the most likely diagnosis, although no definitive tests or findings establish that diagnosis.  @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

a)  Dorothy Calabrese, M.D. has never treated patients “multiple chemical sensitivity syndrome”, a diagnosis by exclusion.  Allergy-immunology patients who also have allergic hypersensitivity to chemicals do not have “multiple chemical sensitivity syndrome.”

b)  No physician would ever treat “multiple chemical sensitivity syndrome” which has no known etiology with transfer factor immunomodulatory therapy a treatment for abnormal cell mediated immunity:

abnormal cell-mediated immunity - condition resulting from a defective immune mechanism; may be primary (due to a defect in the immune mechanism itself) or secondary (dependent upon another disease process), specific (due to a defect in T-lymphocyte system) or nonspecific (due to a defect in one or another component of the nonspecific immune mechanism: the complement, properdin, or phagocytic system).  @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

c) These patients have chemical sensitivities which fall into a very discrete classification known as:  allergic hypersensitivity to chemicals.  This condition is elegantly described and referenced in the prestigious Clinics of North America series.  Bruce R. Gordon, M.A., M.D., F.A.C.S., F.A.A.O.A.; Department of Otology and Laryngology, Harvard University and Massachusetts Eye and Ear Infirmary, Boston writes:   


Allergic hypersensitivity


"Allergic hypersensitivity is the third type of clinical result from chemical exposure and occurs through the formation of protein-bound haptens and the development of IgE-mediated immediate allergic sensitization. Molecules smaller than penta-peptides do not normally react with antigen-processing cells. Chemically reactive haptens easily bind to contractor molecules that will react with antigen processing cells, however, and lymphocytes sensitized in this way can produce antibodies or sensitized cells that react with free chemicals.'

'This mechanism is the mechanism for most drug allergies and also for reactions to mercury, latex, and formaldehyde. Hapten sensitization is common: from 2% to 15% of allergic emergencies are caused by chemicals.  Some chemical  allergies  are  readily  recognized,  for example, reactions to latex or to nickel. Other chemical allergies are difficult to identify, for example, asthma caused by toothpaste flavoring. Delayed chemical allergic reactions may also occur, especially with plastic resins, nickel, and formaldehyde. All four Gell and Coombs classes of hypersensitivity reactions to a chemical may coexist.”

Approaches to testing for food and chemical sensitivities, BR Gordon WB Saunders Otolaryngologic Clinics of North America, 36 (2003) 917-940  [Attachment 1]

The only patients that are accepted for treatment by Dr. Calabrese are those in the third group of chemical sensitivity:  allergic hypersensitivity.  She has twenty-seven years of continuing medical education in allergy-immunology, not toxicology.
 


It was because of the Marna Slocum decision that the term "multiple chemical sensitivity" was used.  ALJ Stanley Sadur, Region IX Appeals, never mischaracterized this mixed clinical diathesis as “multiple chemicals sensitivity syndrome.”  He clearly states “debilitating allergies” and “multiple allergies”  because transfer factor immunomodulatory therapy is specific for allergy-immune patients.

“The claimant (Marna Slocum) suffers from a number of debilitating allergies for which no other effective treatment could be rendered. Accordingly, the undersigned concludes that the use of transfer factor for the treatment of the beneficiary’s multiple allergies was safe and effective in this case and that the transfer factor was reasonable and necessary for treatment of the beneficiary’s illness.”

“After careful consideration of the entire record, the Administrative Law Judge finds that:

• The beneficiary received injections of transfer factor immunomodulatory reagent.
• The beneficiary is diagnosed as having multiple chemical allergies
• The injections of transfer factor immunomodulatory reagent have been shown to be safe and effective for the treatment of the beneficiary’s illness.
• The injections of transfer factor immunomodulatory reagent were reasonable and necessary for the treatment of the beneficiary’s illness or injury.

It is the decision of the undersigned Administrative Law Judge that the transfer factor immunomodulatory reagent is covered under the provisions of Title XVIII of the Social Security Act.  Therefore, the carrier is directed to determine the reasonable charge for the covered item and to make appropriate payment under Part 5 of Title XVIII.”

Judge Stanley S. Sadur
Administrative Law Judge
US Federal Court of Appeals
Office of Hearings and Appeals
San Francisco, CA 94102
April 25, 1989

Marna Slocum is a participating Medicare beneficiary in the joint LCD appeal.  There are significant legal benefits that have derived from the Slocum decision that have protected the right of all our patients to reimbursement for transfer factor immunomodulatory therapy.  In the Slocum case the term “multiple chemical sensitivity” is used to describe symptoms.

d)  Multiple Chemical Sensitivity is used in both medical and legal circles in the usual adversarial ways as discussed in When Science is Too Daunting:  Multiple Chemical Sensitivity, Federal Courts and the Struggling Spirit of Daubert by Carl Johnson Villanova University, Villanova Environmental Law Journal 2000, 11 Vill. Envtl. L.J. 273. 

But the legal standard for causation of the onset of symptoms of multiple chemical sensitivity in relation to a toxic tort or products liability case has no bearing whatsoeveru> on these patients who are not acute or chronic toxicity cases. 

For those who argue that there is no such thing as multiple chemical sensitivity, we are mandated to turn to epidemiologists in public health, for that is their specialty. 

Canadian medicine is socialized and as such has access to all the patient data.  Their elegant epidemiological work by Gail McKeown-Eyssen, Ph.D. Professor Department of Public Health Sciences and Nutritional Sciences, and Lynn Marshall, M.D. Faculty of Medicine University of Toronto, showed that 25% of patients reporting chemical sensitivity have allergy and immune problems.  The McKeown-Eyssen studies are scientifically valid and meet Daubert criteria. Furthermore, the Canadian Government has “no horse in this race.”

Our Medicare beneficiaries who have a most severe clinical presentation and multi-variant genetics, would represent less than 1% of this allergy-immunology subpopulation. 

This speaks to the critical nature of differential diagnosis in the hands of an experienced allergist-immunologist who specializes in this specific patient subset.  

 differential diagnosis - the determination of which of two or more diseases with similar symptoms is the one from which the patient is suffering, by a systematic comparison and contrasting of the clinical findings  @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

prodrome - an early or premonitory symptom of a disease  @ Stedman’s Medical Dictionary 2004 Lippincott Williams & Wilkins

The differential diagnosis for those patients, who report chemical sensitivity, includes but is not limited to: 

• acute toxicity
• chronic toxicity
• allergic hypersensitivity to chemicals
• prodrome of certain malignancies
• psychiatric including but not limited to conversion hysteria, psychotic disorders, factitious disorders, & malingering
• litigation bias / litigation neurosis
• and so forth

One of the difficulties for American physicians, is that so many doctors in clinical medicine have been trained to ignore this patient group. This is a direct result of the lack of basic medical training in the standard medical history to include appropriate questions relevant to chemical sensitivity. As a direct result, the differential diagnosis for patients who report clinically significant sensitivity to chemicals (which are otherwise well-tolerated by normal individuals) is sadly very incomplete.

But this case isn't about the slowly evolving face of medicine when politics intervenes. Our only concern is that decent and honorable taxpayers who made payroll contributions into the Medicare system over their lifetime and continue to pay into the system are being denied medically necessary care, in part because they report being chemically sensitive in addition to their traditional allergy-immunology symptoms. This is illegal. These patients were promised by every politician that Medicare would be there for them when they needed it. . . but it isn't.

Patients with allergic hypersensitivity to chemicals can not be excluded from Medicare reimbursement for transfer factor immunomodulatory therapy. Allergic hypersensitivity to chemicals would never be a limiter on the primary diagnosis of abnormal delayed cell-mediated immunity. Whereas, lympho-proliferative disease and certain auto-immune diseases are limiters.

ALL FILINGS IN THIS CASE:

Medicare Patients File Second Amended Complaint Against EDS & NHIC 07-09-07

Medicare Patients File Federal Lawsuit Against EDS & NHIC 01-03-07

Interrogatories for Bruce Quinn, MD NHIC Medicare Medical Director 04-09-07

Interrogatories for Charity Horton NHIC Hearing Officer 04-09-07

Complaint against NHIC National Heritage Insurance Company Medicare Hearing Office 04-02-07

Production of documents from Medicare, Bruce Quinn MD and Michael H Jordan 03-28-07

2nd Ex parte filing 03-28-07

1st Ex parte filing 02-02-07