The Poughkeepsie Lyme Initiative

V3.0 Part I

Persons who are ill with Lyme and/or Other Arthropod-borne Diseases (LOADs) declare this initiative to reverse the effects of the influence of a group of university-based researchers (UBRs)  who say  "Lyme disease" is Overdiagnosed and Overtreated (1, 2).  It is not yet known what are all the pathogens carried and transmitted via
tick attachment.(3,4).  Therefore, manifestations of illness as a result of infections transferred via tick bite must be evaluated objectively/clinically.

It shall be recognized that the objectives of these UBRs do not include preserving patient wellness, but target the profitability of these diseases.  The vast percentage of NIH grants focuses on diagnostics and vaccine candidate development and not in discovering cures for Tick borne diseases (5, 6, 7).

UBRs who report opinion papers in medical journals regarding outcomes of certain subsets of LOADs patients deliberately and publicly minimize the effects of LOADs patients physical presentation under the umbrella of the broader  term "Lyme Disease", as defined by the Center for Disease Control (CDC) in its case definition (1, 2, 8).  In the process, they discard other manifestations of Lyme disease and/or the Arthropod-borne Diseases (LOADs) with poorer outcomes which are also described by the CDC as other clinical descriptions, by assigning them other diagnoses, even psychiatric ones, without objective criteria for this reassignment. This activity is endorsed by the United States National Institutes of Health (NIH) and CDC (9).

In addition to using various means to deny LOADs patients their health, the character and integrity of LOADs are assaulted, as they are publicly declared "not rational"  as quoted in the press, when patients advocate for a clearer understanding of the results of LOAD infections and cooperation in achieving recovery (10).

International acceptance of the Human Rights Declaration demonstrates acceptance of the respect and protection of the

  1. economic,
  2. social and
  3. somatic (physical health and well-being)
functional autonomy of all people in their struggles against oppression; struggles which harms or destroys life.

LOADs patients frequently suffer the loss of all 3 realms of autonomy due to the unscrupulous activities of this body UBRs as they have chosen to pursue the financial advantages and US CDC and NIH approval in denying patients their right to medical care, when they downplay the severity and reassign the origin of LOADs patients physical complaints.

The effect of the influence of these UBRs, is to diminish LOADs patients' chances for complete recovery and/or relief from their debilitating symptoms and enables social and medical discrimination against LOADs patients, which are violations of the Articles and Prinicples of the International Human Rights Declaration listed below.

LOADs patients will win back their respect as human beings who suffer debilitating diseases which compromise physical and mental functioning as well as see US Government funding more equally distributed to those who seek to find a cure for LOADs, rather than be exclusively distributed to those who are established to profit from prevention and diagnostics.  If funding discovering cures for illnesses such as LOADs is not a goal of the US NIH and CDC, the US government should oversee a shift in the goals of these entities to address these needs.
 

LOADs patients everywhere have the right to sustain a minimum level of functioning and health until such time as cures are found.  It is the LOADspatients obligation to society  and society's obligation to LOADs patients that LOADs patients remain functional, if medical intervention and treatment avails that functionality.

The empirical evidence therefore stands absolute. If antibiotic and/or other treatment improves an LOADs condition, the Lyme Disease Patient (LDP) should not be denied these medical interventions.

The following are the pertinent Human Rights Articles and Principles that defend LOADs right to empirical treatment for Lyme Disease.


APPENDIX

UNITED NATIONS COMMISSIONER

FOR HUMAN RIGHTS

The International Human Rights Charter

http://www.unhchr.ch/udhr/miscinfo/carta.htm

"The Declaration recognizes that the "inherent dignity of all members of the human family is the foundation of freedom, justice and peace in the world" and is linked to the recognition of fundamental rights towards which every human being aspires, namely the right to life, liberty and security of person; the right to an adequate standard of living; the right to seek and to enjoy in other countries asylum from persecution; the right to own property; the right to freedom of opinion and expression; the right to education, freedom of thought, conscience and religion; and the right to freedom from torture and degrading treatment, among others. These are inherent rights to be enjoyed by all human beings of the global village -- men, women and children, as well as by any group of society, disadvantaged or not -- and not "gifts" to be withdrawn, withheld or granted at someone's whim or will."


International Covenant on Economic, Social and Cultural Rights

http://www.unhchr.ch/html/menu3/b/a_cescr.htm

Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966
entry into force 3 January 1976, in accordance with article 27

http://www.un.org/Depts/Treaty/final/ts2/newfiles/part_boo/iv_boo/iv_3.html

ratified by the United States of America October 5, 1977

Preamble

The States Parties to the present Covenant,

Considering that, in accordance with the principles proclaimed in the Charter of the United Nations, recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world,

Recognizing that these rights derive from the inherent dignity of the human person,

Recognizing that, in accordance with the Universal Declaration of Human Rights, the ideal of free human beings enjoying freedom from fear and want can only be achieved if conditions are created whereby everyone may enjoy his economic, social and cultural rights, as well as his civil and political rights,

Considering the obligation of States under the Charter of the United Nations to promote universal respect for, and observance of, human rights and freedoms,

Realizing that the individual, having duties to other individuals and to the community to which he belongs, is under a responsibility to strive for the promotion and observance of the rights recognized in the present Covenant,

Agree upon the following articles:

PART I

Article 1
1. All peoples have the right of self-determination. By virtue of that right they freely determine their political status
and freely pursue their economic, social and cultural development.

2. All peoples may, for their own ends, freely dispose of their natural wealth and resources without prejudice to any obligations arising out of international economic co-operation, based upon the principle of mutual benefit, and international law.  In no case may a people be deprived of its own means of subsistence.

3. The States Parties to the present Covenant, including those having responsibility for the administration of Non-Self-Governing and Trust Territories, shall promote the realization of the right of self-determination, and shall respect that right, in conformity with the provisions of the Charter of the United Nations.

PART II
Article 2
1. Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures.
 
Article 12
1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable
standard of physical and mental health.

2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall
include those necessary for:

(a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

(b) The improvement of all aspects of environmental and industrial hygiene;

(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

(d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.


COMMISSION ON HUMAN RIGHTS

Fifty-first session Item 14 of the provisional agenda

HUMAN RIGHTS AND SCIENTIFIC AND TECHNOLOGICAL DEVELOPMENTS

http://www.unhchr.ch/Huridocda/Huridoca.nsf/TestFrame/18a999a107eda5e38025671600547e8f?Opendocument
 

Human rights and bioethics

12. At its forty-eighth session, in 1996 the Sub-Commission, recognizing that everyone has the right to enjoy the benefits of scientific progress and its applications and noting that at the World Conference on Human Rights it was acknowledged that certain advances, notably in the biomedical and life sciences as well as in information technology, might have potentially adverse consequences for the integrity, dignity and human rights of the individual, decided to entrust one of the members with the task of preparing, without financial implications, a working paper on the potentially adverse consequences of scientific progress and its applications for the integrity, dignity and human rights of the individual, and called on the international scientific community and the international organizations concerned to cooperate (decision 1996/110).

13. The Governments and organizations which sent replies to the communication from the Secretary-General emphasized the need to  ensure that scientific progress benefits individuals and develops in a manner respectful of fundamental human rights.

18. Referring to paragraph 34 of the Secretary-General's most recent report (E/CN.4/1995/74), the Holy See stated that it could be appropriate to recall what had constituted the main argument of the Holy See's reply, namely the inherent dignity of every human being from the first moment of conception, as the basis for the right to life and the principle that should inspire all research in the field of life sciences. The wording of the last sentence of paragraph 34 appears somewhat to distort the meaning of the Holy See's reply. The following wording would be preferable: "... biogenetic research and experimentation touched on vast areas of social life, and determined conditions for the exercise of certain economic and social rights".

19. The Council for International Organizations of Medical Sciences (CIOMS) stated that bioethics in the health sector
should be guided by generally accepted principles, in particular by the principle that an adequate level of health care should be recognized as a universal and fundamental human right. ............

27. Principle 1.4 includes the following provisions relating to improving the cost-effectiveness of resource allocation
and health planning:

"With the development of relatively new methods for measuring the burden of disease on human life that constitute potential tools for guiding decisions for improving the cost-effectiveness (efficiency) of resource allocation and health planning, it is essential that the further refinement of these methods be guided by the principles of equity and non-discrimination on such grounds as age, sex, ethnic  origin, personal status, etc., as well as efficiency, and that countries with an interest in applying these tools be provided with the resources for building capacities for undertaking these analyses in a manner consonant with national and local needs."

28. With respect to applying bioethical concepts to relevant aspects of human rights, principle 2.1 states that:

        "important opportunities exist for applying bioethics concept in developing the content of human rights relating
to health, health protection, and health care. Such rights can be clustered into 3 categories, viz.:
 

  1. rights to health care and to the benefits of scientific progress;
  2. rights relating to information, association, and freedom of action

  3. that could empower groups to protect and promote their health; and
  4. rights relating to self-determination and integrity of the person, including

  5. rights to liberty and security and the right to private life."


 

THE STATE OF LYME DISEASE

Lyme disease is an infectious disease.  The spirochete Borrelia burgdorferi which is transferred via tick attachment and causes Lyme disease, is a slow-growing and persisting organism that appears to live intracellularly and has several other well-recognized means of immune system evasion. Thus one of the infecting organisms upon tick bite, the Lyme disease spirochete, avoids immune and antibiotic destruction (11,12,13,14).

Since it is not known what are all the pathogens transferred via tick bite or attachment, empirical evidence of treatment outcomes is the logical approach to treatment.  Many LOADs patients have been observed to require long courses of antibiotics.  The evidence is that a significant portion of LOADs patients have had symptom resolution even in the absense of positive serology as a result of this clinical view of the condition of symptoms vs. treatment (15)

Substantial scientific evidence exists which supports persistent infection (11,16),  scant evidence to support a Lyme disease infection initiates strictly an autoimmune disease (17).  A diagnostic reassignment of LOADs to an autoimmune disease when symptoms overlap exactly those symptoms which persist in the undertreated LOADs patient, is financially favorable to insurance companies, pharmaceutical companies, and scientists and universities who are involved in anti-inflammatory medicines trials or vaccine trials.

Denying treatment based on the opinion that LOADs exclusively becomes an autoimmune disease without scientific proof is a Human Rights abuse (1,2).

Unethical associations between the medical community  and insurance companies have been overlooked by US legislators (18,19).  No insurance company should sponsor a treatment study of an illness wherein all manifestations of an illness have not been accurately and collectively considered in the study such that the study results could potentially skew the reporting of treatment protocols. (lifeSpan Link)  This serves to enable the insurance company to declare treatment of the various subsets of the illness (i.e. Lyme Disease, the case definition VS clinical descriptions or subsets not included in the study) to be experimental and deny coverage for treatment on that basis (20).
 
 

OUTER SURFACE PROTEIN A: the Vaccine

At the present time, the primary candidate molecule for causing an auto-immune condition or for creating a cross-reacting antibody, (an antibody created against the host as well as the infectious organism- or an autoimmune condition) is recombinant Outer Surface Protein A, or rOSP A, the molecule that has been recombinantly designed for and is currently marketed as a vaccine against Lyme disease (17, 21).  This means that a primary suspect in initiating an alleged autoimmune process is the very vaccine molecule proposed by, and advocated for public use of by, these same UBRs scientists who say Lyme disease is easily cured and that persons with continued symptoms no longer have Lyme disease (1,2).

This dismissal of selected facts and potentially harmful evidence demonstrates a lack of medical  integrity, as is attempting to purvey the vaccine as a remedy for the anxiety over Lyme Disease.
 
 

THE STANDARD OF CARE

The current international consensus on treatment for "Lyme disease" and therefore Other Tick-borne Diseases, is that there is No Consensus.  The annual Lyme Disease Foundation International Conference on Lyme and other Tick Borne Disorders avails LOADs patient-treating physicians a forum for comparing their treatment approaches in the
Treatment Roundtables.  Such a forum would not be necessary if there was single internationally accepted treatment protocol.

Presently there is no absolute known cure for all cases or clinical descriptions of LOADs as they manifest beyond the first 30 days after infection.

For these reasons, no one person is expert in the standard of care of for clinical descriptions of Lyme disease and/or concurrent Tick-borne diseases (TBDs).

LOADs patients have the right to be treated with antibiotics and other mechanisms of immune and health enhancement, if they feel they would like to at least try being treated or have discovered that treatment effects improvement in their symptoms until cures are found, as is the agreement signed by the US Government in the
Human Rights Declaration.

Since an entirely effective medical treatment regimen has not yet been determined, the empirical evidence in the individual patient case, or patient response to available therapeutic intervention, with informed consent of the patient, must determine the course of the LOADs patients treatment.


HUMAN RIGHTS VIOLATIONS IN LYME DISEASE: DENIAL OF ACCESS TO HEALTH CARE

Patients experience medical negligence and a Human Rights abuse.

The objective of medicine is still to effect healing.  It is a Human Rights abuse for a physician


The correct and logical approach in this situation to try to effect patient recovery or at least, dimunition in disabling symptoms. Choosing an autoimmune disease as the diagnosis serves the goals of insurance companies and the goals of the CDC, which is to downplay the seriousness of TBDs.

LOADs patients, through this activity of reassigning their diagnoses of an infectious disease to an auto-immune illness, are being denied the right to obtain medical treatment for difficult to cure disease, and possibly, set of diseases, which affect a patients ability to be functioning, contributing members of society, and is known to require the highest standard of treatment.  Treatment of an illness with the highest medical standard of treatment available
is a Human Right agreed to by the United States upon ratification of the the International Declaration of Human Rights.

The view that persons with diseases should be left untreated for the purpose of

this latter philosophy has begun to re-emerge sporadically in western society in the agenda of some proponents of a global world order in which preservation of the environment has priority over the preservation of human life. Such agendas clearly are not consistent with the protection of Human Rights as a means of preventing violent conflicts and the destruction of natural resources.
 
 

INDEPENDENT MEDICAL EVALUATIONS AND PAID TESTIMONY

If it financially serves insurance companies by not paying for treatment and financially benefits the physicians who provide them with paid testimony by performing independent medical evaluations, the evaluation is not independent. If and the testimony is clearly not objective.

It is not logical for a diagnostician

This is particularly questionable testimony when When the testimony is no longer independent.

If it financially serves insurance companies to retain medical experts who cite opinion papers

the insurance company experts are only expert at providing medical opinion that fits the fiscal objectives of the insurance company.

These activities are deliberate means of denying patients treatment of LOADs and are therefore a human rights violation.

All communities worldwide should be aware of these mechanisms of denying or reassigning diagnosis and thus
restricting treatment, as it may not be restricted to practice in LOADs cases. Just as the discovery of new types of arthropod-borne infections is rising exponentially, so too is the potential for the type of human rights abuses that LOADs patients now suffer.
 

VIOLATIONS TO HUMAN DIGNITY

Using positions of medical scientific authority to is an offense against human dignity. When LOADs patients are so criticized, they are being kept from medical treatment resulting in an inadequate standard of living as they become progessively more disabled by their illness. The results of such in medical journal articles is medical negligence and potentially effects a lack of medical objectivity of their present and future medical conditions.

When it is inferred that patients, instead,

rather than an infectious disease, it is implied that This is a violation of human dignity, as it results in prejudice and thus a restriction of economic and social autonomy and access to objective medical care.
 

OFFENSES TO PRINCIPLE 1.4 HUMAN RIGHTS AND SCIENTIFIC AND TECHNOLOGICAL DEVELOPMENTS (Human rights and bioethics) IN LYME DISEASE

Offenses that occur in LOADs:
 
  1. Not reporting cases of Lyme disease to the CDC for the purposes of surveillance.  This affects the accuarte determination of the burden of Lyme disease and/or other Tick Borne Diseases (TBDs) in the United States. It violates Principle 14 (Human rights and bioethics) as it interferes with resource allocation.
  2. Not recording or reporting adverse vaccine reactions. This is a Human Rights violation in that it prevents the delivery of data which may protect others from the harm of such a vaccine.

  3. Physicians 

    violate these Principles, as well as being illegal in the United States.

    The anecdotal evidence is that some patients who were both infected with Borrelia burgdorferi and administered recombinant OSP A, the vaccine, suffer adverse effects. The evidence exists for this in animal studies (21).  It is a violation of Principle 14 to not report the adverse effects of new biotechnology products, such that they continue to be used and threaten the well-being of others.
     

  4. Investing excessive US NIH funding for developing commercially valuable biotechnology to the near exclusion of funding endeavors to discover specific cures for Lyme and other TBDs or funding research that excludes clinical description subsets of Lyme disease.

  5. Efforts by many US UBRs and other scientists to identify Borrelia burgdorferi genetic material for patenting and use

    far exceed the US Department of Health investment in finding a cure for Lyme disease.

    The potential exists for biotechnology entrepreneurs who are recipients of NIH funding for these endeavors to later interpret the existence of LOADs infections based on the patients serological response.
     

  6. Replacing the diagnosis of a patient with an infectious disease with a diagnosis of a disease that is thought to be an autoimmune disease also effects a false record of the prevalence of both the infectious disease and the autoimmune illnesses and inappropriately shifts the balance of funding away from the study of the infectious disease (1)
It shall be recognized by the example of the Human Rights abuses in Lyme and/or Other Arthropod-borne Diseases, that the potential exists to interpret the definitions and clinical manifestations of other diseases to suit the potential profitability of those diseases.
 



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REFERENCES


(1) The Overdiagnosis of Lyme Disease. Steere, AC,
Taylor, E., McHugh, MS, Logigian, EL. April 14, 1993, JAMA, Vol 269, pp.
1812-1816

(2)  Reid, M.C., R.T. Schoen, J. Evans, J.C. Rosenberg, and R.I.
Horwitz.
1998. The consequences of overdiagnosis and overtreatment of Lyme
disease. Ann Int Med 128:354-362. .

(3) J Wildl Dis 1997 Jul;33(3):466-73
Antibodies to multiple tick-borne pathogens of babesiosis,
ehrlichiosis, and Lyme borreliosis in white-footed mice.
Magnarelli LA, Anderson JF, Stafford KC 3rd, Dumler JS
Department of Entomology, The Connecticut Agricultural Experiment
Station 06504, USA.

(4) J Med Entomol 1995 Nov;32(6):765-77
General framework for comparative quantitative studies on
transmission of tick-borne diseases using Lyme borreliosis in
Europe as an example.
Randolph SE, Craine NG
Department of Zoology, University of Oxford, United Kingdom.

(5)  FDA TALKPAPER pub number: T-99-10  Pre Vue
Borrelia burgdorferi Test Kit

(6) University making a killing off drug patent
AIDS drug has produced millions of dollars for Yale's coffers
By Erin White
http://www.yale.edu/ydn/paper/4.7.97/i-1drug.html

(7) NIH Grants related to Lyme disease:
http://www.geocities.com/HotSprings/Oasis/6455/grants-all-institution.txt

(8)  JAMA Vol. 283 No. 5, February 2, 2000
Elyse G. Seltzer, MD; Michael A. Gerber, MD;
Matthew L. Cartter, MD; Kimberly Freudigman, PhD; Eugene D. Shapiro, MD
Long-term Outcomes of Persons With Lyme Disease

(9)  Allen Steere honored as Astute Clinician by NIH. Talk given
November3, 1999, NIH, Bethesda, MD

(10) The Boston Herald, Novermber 3, 1999,
Patients to protest talk by Lyme disease discoverer
 by Michael Lasalandra
http://www.bostonherald.com/bostonherald/health/lyme11031999.htm

(11) Long-Term Inflammation in Lyme Borreliosis
A Medline-Literature Survey by Joachim Gruber
Date: February 3, 1999
http://www.lymenet.de/LITERATUR/niches.htm

(12) The fate of Borrelia burgdorferi, the agent for Lyme disease, in
mouse macrophages. Destruction, survival, recovery. Montgomery RR;
Nathanson MH; Malawista SE
Address Department of Internal Medicine, Yale University School of
Medicine, New Haven, CT 06510.J Immunol, 150(3):909-15 1993 Feb 1

(13) Invasion and cytopathic killing of human lymphocytes by
spirochetes causing Lyme disease.   Dorward DW; Fischer ER;
Brooks DM   National Institute of Allergy and Infectious Diseases,
Rocky Mountain Laboratories, Hamilton, Montana 59840, USA. Clin
Infect Dis, 25 Suppl 1():S2-8 1997 Jul

(14) Genomic sequence of a Lyme disease spirochaete, Borrelia
burgdorferi. Fraser CM; Casjens S; Huang WM; Sutton GG; Clayton R;
Lathigra R; White O; Ketchum KA; Dodson
R; Hickey EK; Gwinn M; Dougherty B; Tomb JF; Fleischmann RD;
Richardson D; Peterson J; Kerlavage AR; Quackenbush J; Salzberg S;
Hanson M; van Vugt R; Palmer N; Adams MD; Gocayne J; Venter
JC; et al The Institute for Genomic Research, Rockville,
Maryland 20850, USA. Nature, 390(6660):580-6 1997 Dec 11

(15) Donta, S.T.,Clinical Infectious Diseases, 1997 (Suppl 1):S52-6
Tetracycline Therapy for Chronic Lyme Disease,
Boston University Medical Center and Boston Veterans Affairs Medical
Center, Massachusetts 02118, USA.

(16) Art Dohertys Links on Lyme
Persistence (link no longer active)
http://www.geocities.com/HotSprings/Oasis/6455/persistence-biblio.html
Others (link no longer active)
http://www.geocities.com/HotSprings/Oasis/6455/lyme-links.html

(17)  Huber, B, and Gross, D.,  Comment Viewpoint
Trends in Microbiology 211, vol 6 no 6 June 1998
"The mimic of molecular mimicry uncovered
Tufts Pathology

(18) NEMC and LifeSpan in partnership
http://www.nemc.org
Steere is involved in an NIH granted treatment study of Chronic Lyme
disease which excludes patients who are seronegative, although
seronegativity is recognized by the CDC as a condition of Lyme disease
and does not preclude its diagnosis.
http://www.NEMC.org/gcrc/lymedescrip.htm
http://www.NEMC.org/gcrc/why%5Fparticipate.htm

(19) Evans and Managed Care  From the Yale Rheumatology website:
Janine Evans, M.D., Associate Professor of Medicine, Associate Program Director
My interests are clinically oriented and focus on Lyme
disease...  Another area of interest has been in managed care.
I have been appointed as the Medical Director of Yale New Haven
Hospitals Independent Physicians Association, an organization composed of the
majority of physicians with privileges at Yale New Haven Hospital. As
the percent of patients enrolled in managed care programs increases we
have been designing and implementing ways of managing our costs while
maintaining the delivery of high quality medical care.
Evans References include:
Reid, M.C., R.T. Schoen, J. Evans, J.C. Rosenberg, and R.I. Horwitz.
1998. The consequences of overdiagnosis and overtreatment of Lyme
 disease. Ann Int Med 128:354-362. .

(20)  CDC Case and clinical descrptions of Lyme Disease
"Case Definitions for Infectious Conditions Under Public Health Surveillance
MMWR 46(RR10);1-55
Publication date: 05/02/1997
http://wonder.cdc.gov/wonder/prevguid/m0047449/entire.htm#Table_1
LYME CLINICAL DESCRIPTION AND DIAGNOSIS
http://www.cdc.gov/ncidod/dvbid/Lymediagnosis.htm

(21) Schell, R, et al, University of Wisconsin, Madison. Infection and
Immunity 2000;68:658-663.
Occurrence of severe destructive lyme arthritis in hamsters
vaccinated with outer surface protein A and challenged with
Borrelia burgdorferi.
Croke CL, Munson EL, Lovrich SD, Christopherson JA, Remington MC,
England DM, Callister SM, Schell RF
Wisconsin State Laboratory of Hygiene, University of Wisconsin, Madison,
Wisconsin 53706, USA.



Dedicated to Armen, Sandy and Pat

Acknowledgements:
Art, Karen, Joachim, Ken, Lynn, Harold, Marjorie, Georgia



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