Yet Another Tuskegee Study?

[Guest guest]

PERMISSION TO REPOST -- PLEASE CIRCULATE CDC PROPOSAL AND OPINION TOGETHER.

THANK YOU. TINA J. GARCIA

I have written an opinion piece that is my interpretation of the CDC Project

Proposal below. I have added emphasis to parts of this CDC Proposal that I

refer to in my Opinion Piece below, which is also in bold type. Tina J.

Source: U.S. Federal Register

Volume 72, Number 246, Page 73023-73024

Date: December 26, 2007

URL: http://frwebgate1. access.gpo. gov/cgi-bin/ waisgate. cgi?WAISdocID=

85231218255+ 6+0+0 & WAISaction =retrieve

DEPARTMENT OF HEALTH AND HUMAN SERVICES

------------ --------- --------- ---------

Centers for Disease Control and Prevention

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of

information collection requests under review by the Office of Management

and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these requests, call the CDC Reports

Clearance Officer at (404) 639-5960 or send an e-mail to omb@.... Send

written comments to CDC Desk Officer, Office of Management and Budget,

Washington, DC or by fax to (202) 395-6974. Written comments should be

received within 30 days of this notice.

Proposed Project

Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb County,

Georgia)--New- -National Center for Zoonotic, Vector-borne, and Enteric

Diseases (NCZVED), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is tasked with establishing a registry of chronic fatigue syndrome

(CFS) and other fatiguing illnesses. The objective of the registry is to

identify persons with unexplained fatiguing illnesses, including CFS, who

access the healthcare system because of their symptoms. Patients will be

between the ages of 12 and 59, inclusive.

Specific aims of the registry are: (1) Identify and enroll patients with

CFS and other unexplained fatiguing illnesses who are receiving medical

and ancillary medical care and describe their epidemiologic and clinical

characteristics; (2) follow CFS patients and patients with other fatiguing

illnesses over time to characterize the natural history of CFS and other

unexplained fatiguing illnesses; (3) assess and monitor health care

providers' knowledge, attitudes, and beliefs concerning CFS) and to

identify well-characterized CFS patients for clinical studies and

intervention trials. These specific aims require inclusion of subjects in

early stages of CFS (i.e., ill less than one year duration) who can be

followed longitudinally to assess changes in their CFS symptoms. Data on

persons with CFS in the general population has been collected in a

separate study and is not an objective of this Registry.

In order to determine the most effective and cost-efficient design for

achieving the objective and specific aims, CDC will conduct a pilot test

of the Registry of CFS and other fatiguing illnesses in Bibb County,

Georgia. The CFS Registry Pilot Test will assess two Registry designs for

efficacy and efficiency in identifying adult and adolescent subjects with

CFS who are receiving medical and ancillary medical care. Specifically,

the CFS Registry Pilot Test will evaluate surveillance of patients with

CFS identified through physician practices and a surveillance of CFS

patients identified by physicians and other health care providers.

The proposed study will begin when a provider refers a patient to the

registry. Patients who consent to be contacted for the registry will be

asked to complete a detailed telephone interview that screens for medical

and psychiatric eligibility. Eligible subjects will be invited to have a

clinical evaluation that comprises a physical examination; collection of

blood, urine, and saliva specimens; a mental health interview; and

self-administered questionnaires.

There is no cost to respondents other than their time. Patients who are

clinically evaluated will be reimbursed for their time and effort. The

total estimated annualized burden hours are 2,077.

Estimated Annualized Burden Hours

------------ --------- --------- --------- --------- --------- -

Number of Number of Average hours

Form respondents responses per response

per respondent

------------ --------- --------- --------- --------- --------- -

Health Care Provider Verification Form........ ......... ......... 583 1 17/60

Health Care Provider Knowledge, Attitudes and Beliefs 466 1 8/60

Questionnaire (Pre-intervention) ......... ......... ......... ....

Health Care Provider Knowledge, Attitudes and Beliefs 373 1 8/60

Questionnaire (Post Intervention) ......... ......... ......... ...

Health Care Provider Knowledge Attitudes and Beliefs 100 1 8/60

Questionnaire (at CDC presentations) ......... ......... .........

Referral/Consent to Contact Form........ ......... ......... ...... 373 2 8/60

Referral/Consent to Contact Form (Patient)... ......... ......... . 507 1 12/60

CATI Detailed Telephone Interview... ......... ......... ......... . 395 1 42/60

Health Care Utilization/ Sense of Community (for adult)...... .... 196 1 20/60

Health Care Utilization (for parent of adolescent). ......... .... 50 1 20/60

Economic Impact (adult)..... ......... ......... ......... ......... 196 1 20/60

Spielberger State-Trait Anxiety Inventory (for adult subjects).. 196 1 20/60

Personality Diagnostic Questionnaire (PDQ-4+) (for adults)..... . 196 1 42/60

Childhood Trauma Questionnaire (for adult subjects)... ......... . 196 1 25/60

Traumatic Life Events Questionnaire (for adult subjects)... ..... 196 1 20/60

Life Experiences Survey (for adult subjects)... ......... ........ 196 1 20/60

Adolescent Subject Fatigue Questionnaire. ......... ......... ..... 50 1 8/60

Adolescent Health Questionnaire. ......... ......... ......... ..... 50 1 20/60

Symptoms Inventory... ......... ......... ......... ......... ....... 246 1

12/60

Medical Outcomes Study Short Form 36.......... ......... ......... 246 1 20/60

Multi-dimensional Fatigue Inventory... ......... ......... ........ 246 1 12/60

Zung Self-Rating Depression Scale....... ......... ......... ...... 246 1 20/60

Illness Perception Questionnaire. ......... ......... ......... .... 246 1 20/60

son Trauma Scale....... ......... ......... ......... ......... 246 1 12/60

Ironson-Woods Spirituality/ Religiousness Index....... ......... .. 246 1 8/60

Illness Management Questionnaire. ......... ......... ......... .... 246 1 20/60

Ways of Coping Questionnaire. ......... ......... ......... ........ 246 1 33/60

Social Support Questionnaire. ......... ......... ......... ........ 246 1 20/60

------------ --------- --------- --------- --------- --------- -

Dated: December 14, 2007.

am I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and

Prevention.

[FR Doc. E7-24933 Filed 12-21-07; 8:45 am]

BILLING CODE 4163-18-P

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© 2007 U.S. Federal Register

YET ANOTHER TUSKEGEE STUDY?

OPINION OF TINA J. GARCIA RE CDC PROJECT PROPOSAL TO

Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb County,

Georgia)--New- -National Center for Zoonotic, Vector-borne, and Enteric

Diseases (NCZVED), Centers for Disease Control and Prevention (CDC).

BACKGROUND LINKS RELATED TO TUSKEGEE STUDY:

The PHS is still in existence as the seventh branch of U.S. Military:

http://www.usphs.gov/aboutus/questions.aspx#whatis

Commissioned Corps Officers receive military compensation from the

Department of Defense (DOD):

http://www.usphs.gov/questionsanswers/compensation.aspx#2

FROM CDC REGISTRY/STUDY PROPOSAL:

" Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb County,

Georgia)--New- -National Center for Zoonotic, Vector-borne, and Enteric

Diseases (NCZVED), Centers for Disease Control and Prevention (CDC). "

OPINION:

- Why is Chronic Fatigue Syndrome (CFS) categorized in the zoonotic,

vector-borne and enteric diseases section of the CDC? CDC research has noted

possible viral etiology. Are these viruses being transmitted through food

supply or through vectors being studied in biowarfare labs?

- The term " Registry " is another name for " Study " , as in Tuskegee Study.

FROM CDC REGISTRY/STUDY PROPOSAL:

" The objective of the registry is to identify persons with unexplained

fatiguing illnesses, including CFS, "

OPINION:

- What other unexplained fatiguing illnesses are included in this

Registry/Study?

FROM CDC REGISTRY/STUDY PROPOSAL:

" Specific aims of the registry are:

(1) Identify and enroll patients with CFS and other unexplained fatiguing

illnesses who are receiving medical and ancillary medical care and describe

their epidemiologic and clinical characteristics; "

OPINION:

- Again, what other unexplained fatiguing illnesses is the CDC going to

include in this CFS Registry/Study? This appears to be a vague reference to

particular illnesses.

- Epidemiologists will need to evaluate the epidemiologic characteristics --

enter US Public Health Service Commisssioned Corps, Epidemic Intelligence

Service Officers, who led the Tuskegee Study.

FROM CDC REGISTRY/STUDY PROPOSAL:

2) follow CFS patients and patients with other fatiguing illnesses over time

to characterize the natural history of CFS and other unexplained fatiguing

illnesses;

" The total estimated annualized burden hours are 2,077. "

OPINION:

- To follow CFS patients and patients with other fatiguing illnesses " over

time " is a repeat of the Tuskegee Syphilis Study that also lasted " over time "

some 40 long years. " Over time " is another vague reference and the time period

should be delineated. Annualized burden hours infers this REGISTRY/STUDY may go

on for years.

FROM CDC TUSKEGEE TIMELINE:

http://www.cdc.gov/tuskegee/timeline.htm

" In 1932, the Public Health Service, working with the Tuskegee Institute,

began a study to record the natural history (there are those words again,

natural history) of syphilis in hopes of justifying treatment programs for

blacks. It was called the " Tuskegee Study of Untreated Syphilis in the Negro

Male. " ....Although originally projected to last 6 months, the study actually

went on for 40 years. "

" 1936 Major paper published. Study criticized because it is not known if men

are being treated. Local physicians asked to assist and asked not to treat men.

It was also decided to follow the men until death. "

FROM CDC REGISTRY/STUDY PROPOSAL:

(3) assess and monitor health care providers' knowledge, attitudes, and

beliefs concerning CFS) and to identify well-characterized CFS patients for

clinical studies and intervention trials. These specific aims require inclusion

of subjects in early stages of CFS (i.e., ill less than one year duration) who

can be followed longitudinally to assess changes in their CFS symptoms. Data on

persons with CFS in the general population has been collected in a separate

study and is not an objective of this Registry.

OPINION:

- What is the CDC's purpose in the aim to " assess and monitor health care

providers' knowledge, attitudes, and beliefs concerning CFS " ? How will this be

accomplished, by notation on a CDC health care provider assessment/evaluation

form or maintained in a CDC health care provider file?

- Will the CDC control the knowledge disseminated to the health care providers

and treatment options, if any, afforded to their patients? Will the CDC dictate

the attitude that a health care provider must display to their patient regarding

CFS or other unexplained fatiguing illness? Will the CDC control the beliefs of

the health care provider regarding fatiguing illnesses?

- What action will the CDC take if the health care providers' knowledge,

attitudes and beliefs differ from those of the CDC, the all-knowing agency that

CONTROLS disease and PREVENTS treatment?

- Will anonymous complaints be filed with State Medical Boards by henchman on

the payroll, as we have witnessed with several Lyme disease-treating physicians,

that will initiate costly, punitive and intimidating prosecution that

establishes a standard of care that consists of virutally NO TREATMENT AT ALL?

-Do health care providers understand that if they encourage their patients to

enroll in the Registry/Study, they will also be enrolling themselves to have

their knowledge, attitudes and beliefs scrutinized and most likely corrected and

dictated by the CDC?

FROM CDC TUSKEGEE TIMELINE:

http://www.cdc.gov/tuskegee/timeline.htm

" 1936 Major paper published. Study criticized because it is not known if men

are being treated. Local physicians asked to assist and asked not to treat men.

It was also decided to follow the men until death. "

1940 Efforts made to hinder men from getting treatment ordered under the

military draft effort. "

OPINION:

- Will health care providers abandon their Hippocratic Oath of " First do no

harm " and give up their right and obligation to treat their patients through

their agreement to be complicit partners in crime with the CDC in deciding what

treatment, if any, is provided to patients?

FROM CDC REGISTRY/STUDY PROPOSAL:

" The proposed study will begin when a provider refers a patient to the

registry. Patients who consent to be contacted for the registry will be asked to

complete a detailed telephone interview that screens for medical and psychiatric

eligibility. Eligible subjects will be invited to have a clinical evaluation

that comprises a physical examination; collection of blood, urine, and saliva

specimens; a mental health interview; and self-administered questionnaires. "

" (3) assess and monitor health care providers' knowledge, attitudes, and

beliefs concerning CFS) and to identify well-characterized CFS patients for

clinical studies and intervention trials. These specific aims require inclusion

of subjects in early stages of CFS (i.e., ill less than one year duration) who

can be followed longitudinally to assess changes in their CFS symptoms. Data on

persons with CFS in the general population has been collected in a separate

study and is not an objective of this Registry. "

OPINION:

-Is this truly going to be appropriate informed consent? Will the patients

only agree to participate in the Registry/Study without being informed of the

risks associated with delayed treatment for illnesses of unknown etiology and/or

experimental treatment through their participation in clinical and intervention

trials?

- Can a patient actually consider the collection of blood, urine and saliva

specimens, questionnaires and receiving experimental therapy through clinical

and intervention trials as benefits of participation in the Registry/Study?

Even the Tuskegee participants were given more than one free medical exam. With

no disrespect toward these shamefully neglected and abused individuals, they did

receive free meals and burial expenses! Or will that be the reimbursement for

time and effort referred to in the last paragraph of the CDC Proposal?

-If experimental subjects will be qualified for clinical and intervention

trials, it is common sense that all other treatments will be WITHHELD, otherwise

the clinical and intervention trials will be for nought! How might that effect

the patients' health, if indeed, the CFS or fatiguing illness is of viral or

bacterial origin?

- Is the CDC an official human subject RECRUITER for pharmaceutical industry

clinical drug trials? It appears from this " Registry " that is the case!

- Will participating health care providers, through their own choice and

complicity, be willing to accept the possible ill consequences experienced by

their patients through the withholding of treatment per CDC instructions for

long periods of time and/or through experimental treatment in pharmaceutical

clinical drug trials?

- Since the CDC, in all its wisdom, experience and millions of dollars spent on

research (without coming to any conclusions regarding the etiology of these

strange and baffling fatiguing illnesses), will be " monitoring " the knowledge,

attitudes and beliefs of the health care providers responsible in part for the

health outcome of their patients, perhaps the participating patients will not

receive any relief or answers regarding the cause of their CFS or other

unexplained fatiguing illnesses, which is why they went to see their health care

provider in the first place.

This CONTROL of CFS and other fatiguing illnesses and PREVENTION of treatment,

as in the previous 40-year Tuskegee Study and the ongoing 30-plus-year Lyme

Disease Study, will ultimately cast these Registry/Study participants into what

I have coined as a

SENTENCE TO LIFE IN PRISON FOR THE CHRONICALLY ILL

Written by Tina J.

Contact: tinajgarcia@...

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