IOM Report on Vaccine Safety Oversight Released

February 17, 2005

Just issued by the IOM - their report on openig the VSD to outside

researchers and instilling more transparency into the vaccine safety

research process. Full report can be purchased from IOM at --

*_*_http://books.nap.edu/catalog/11234.html?onpi_newsdoc02172005_*_*

_______________________________

Date: Feb. 17, 2005

Contacts: Stencel, Media Relations Officer

Dobbins, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <news@...>

*FOR IMMEDIATE RELEASE*

*Independent Oversight of Vaccine Safety Data Program Needed *

*To Ensure Greater Transparency and Enhance Public Trust*

WASHINGTON -- Two new oversight groups are needed to ensure that the

policies and procedures of the Vaccine Safety Datalink (VSD) and its

data sharing program -- which is intended to give researchers access to

patient data that will help them study vaccine safety issues -- are

implemented as fairly and openly as possible, says a new report from the

Institute of Medicine of the National Academies. The Centers for Disease

Control and Prevention, which oversees VSD and the data sharing program,

should create a new, independent committee to review researchers'

proposals to use VSD data, monitor adherence to protocols, and advise

the agency and its partners on when and how to release preliminary

findings based on the data, the report says. In addition, CDC should

create a new subcommittee of the National Vaccine Advisory Committee

(NVAC), or tap an existing one, to enable stakeholders to review and

provide input on the VSD research plan every year.

" Concerns about access and transparency have accompanied the development

and functioning of the Vaccine Safety Datalink data sharing program, and

consequently some people's trust in the reliability of findings from VSD

studies has eroded, " explained C. Bailar III, chair of the

committee that wrote the report and emeritus professor of health studies

at the University of Chicago. " Taking steps to improve the independence,

transparency, and fairness of VSD procedures will help enhance

confidence in the data sharing program and in research based on this

important tool for evaluating vaccine safety. "

The Vaccine Safety Datalink is a large, linked database of patient

information that was developed jointly by CDC and several private

managed care organizations in 1991. It includes data on vaccination

histories, health outcomes, and characteristics of more than 7 million

patients of eight participating health organizations. Researchers from

CDC and the managed care groups have used VSD information to study

whether health problems are associated with vaccinations. The subsequent

VSD data sharing program was launched in 2002 to allow independent,

external researchers access to information in the database. Four

successive versions of guidelines for external researchers who wish to

use VSD data have been released; the most recent draft is posted in the

Federal Register with a March 1 deadline for public comment.

Because of certain unique characteristics, the VSD data sharing program

does not function in the same way that other data sharing programs do.

In addition to the protections accorded to patient information by

privacy laws, the participating managed care organizations maintain

proprietary control over data they have supplied from 2001 onward. This

means that these data are not available to external researchers working

independently on most types of studies. Even so, because the VSD is a

tax-supported public resource used to inform health policy decisions,

the public deserves access to the data that influence such decisions,

the report says; the public also is entitled to transparency and

independence in the processes that permit or restrict access. The

committee concluded that it is possible to facilitate public access and

transparency while also protecting patient privacy.

The public should be involved in setting priorities for VSD research,

given the controls placed on information available through the VSD data

sharing program, the report says. To that end, a subcommittee of NVAC

with representation from a wide variety of stakeholders -- from vaccine

manufacturers to federal agencies to advocacy groups -- should provide

feedback and input on the program's research plan each year. Although

such a group would inevitably have biases and conflicts of interest, it

is important that VSD officials hear from all interested individuals. To

promote transparency, the subcommittee's deliberations should take place

in open meetings.

A separate, independent committee should review research proposals to

use VSD data to ensure that they meet the criteria for access. In the

interest of fairness and openness, CDC needs to spell out more clearly

these criteria, among which the technical feasibility of the proposal

should be paramount, the report added. The committee also should oversee

changes in research protocols for VSD studies conducted by researchers

from CDC or the managed care groups. Members of this independent review

committee should be chosen on the basis of their scientific and

technical expertise and their lack of conflicts of interest or biases,

or CDC's ability to balance these.

Another key function of the independent review committee should be to

counsel VSD scientists and officials on when and how to release

preliminary findings from studies based on VSD data. In some instances,

public disclosure of preliminary findings based on incomplete data or

analyses that have not undergone external peer review may be necessary

to protect the public's health and safety. But early release can lessen

people's confidence in the final results of a study if further data

collection and analysis lead to different final conclusions. In nearly

all situations, preliminary findings should undergo independent,

external peer review before they are shared with the public or used as

the basis of policy decisions, the report says.

Given that the managed care organizations maintain proprietary control

over data collected beginning in 2001, independent, external researchers

will have to collaborate with a partner from CDC or one of the health

groups to gain access to these data. Although it is impossible to make

collaboration mandatory, CDC should require each participating managed

care group to designate an individual whose role is to facilitate and

encourage partnerships.

Because any breach of patient data confidentiality could discourage the

managed care groups from participating, CDC should make certain that its

rules for addressing confidentiality violations are clearly spelled out

in the program* *guidelines and agreement forms, the report says. In

addition, the committee concluded that it is reasonable to expect

independent, outside researchers to provide VSD officials with status

reports on their studies. When scientists have findings ready for public

release, they should be required to provide CDC copies of any

manuscripts at least 30 days before submission for publication and

copies of presentations to be given at public events at least 15 days in

advance.

The study was sponsored by Centers for Disease Control and Prevention.

The Institute of Medicine is a private, nonprofit institution that

provides health policy advice under a congressional charter granted to

the National Academy of Sciences. A committee roster follows.

Pre-publication copies of *_Vaccine Safety Research, Data Access, and

Public Trust_*

<http://books.nap.edu/catalog/11234.html?onpi_newsdoc02172005>* *are

available from the National Academies Press; tel. 202-334-3313 or

1-800-624-6242 or on the Internet at *_http://www.nap.edu_*

<http://books.nap.edu/>. Reporters may obtain a copy from the Office of

News and Public Information (contacts listed above).

[ This news release and report are available at

*http://national-academies.org <http://national-academies.org/> *]

INSTITUTE OF MEDICINE

Board on Population Health and Public Health Practice

*Committee on the Review of the National Immunization Program's *

*Research Procedures and Data Sharing Program*

* C. Bailar III, M.D., Ph.D. (chair)*

Professor Emeritus

Department of Health Studies

University of Chicago

Washington, D.C.

*Garnet L. , Ph.D.*

Co-Principal Investigator

Women's Health Initiative Clinical Coordinating Center

Fred Hutchinson Cancer Research Center

Seattle

* E. Fienberg, Ph.D.*

Maurice Falk University Professor of Statistics and

Social Science

Carnegie Mellon University

Pittsburgh

*Debra R. Lappin, J.D.*

Senior Adviser

Public Health and Life Sciences Consulting

B & D Sagamore

Washington, D.C.

*Mryon M. Levine, M.D., D.T.P.H.*

Professor and Director

Center for Vaccine Development

School of Medicine

University of land

Baltimore

* C. Mastroianni, J.D. M.P.H.*

Assistant Professor

School of Law and Institute for Public Health Genetics

University of Washington

Seattle

*Colin L. Soskolne, Ph.D.*

Professor

Department of Public Health Sciences

University of Alberta

Edmonton, Alberta

Canada

*Elaine Vaughan, Ph.D.*

Associate Professor

Department of Psychology and Social Behavior

School of Social Ecology

University of California

Irvine

INSTITUTE STAFF

* Pernack Anason, M.P.H.*

Study Director

February 17, 2005

Since the CDC has demonstrated a willingness to dilute its own findings,

to have its diluted findings presented as research (Verstraeten et al

2003), and to direct the IOM to endorse the diluted findings and to

decree against further research, no VSD-data project in which the CDC a

directing role can be trusted.

Sallie Bernard wrote:

>Just issued by the IOM - their report on openig the VSD to outside

>researchers and instilling more transparency into the vaccine safety

>research process. Full report can be purchased from IOM at --

>

>*_*_http://books.nap.edu/catalog/11234.html?onpi_newsdoc02172005_*_*

>

>_______________________________

>

>Date: Feb. 17, 2005

>Contacts: Stencel, Media Relations Officer

>Dobbins, Media Relations Assistant

>Office of News and Public Information

>202-334-2138; e-mail <news@...>

>

>*FOR IMMEDIATE RELEASE*

>

>*Independent Oversight of Vaccine Safety Data Program Needed *

>*To Ensure Greater Transparency and Enhance Public Trust*

>

>WASHINGTON -- Two new oversight groups are needed to ensure that the

>policies and procedures of the Vaccine Safety Datalink (VSD) and its

>data sharing program -- which is intended to give researchers access to

>patient data that will help them study vaccine safety issues -- are

>implemented as fairly and openly as possible, says a new report from the

>Institute of Medicine of the National Academies. The Centers for Disease

>Control and Prevention, which oversees VSD and the data sharing program,

>should create a new, independent committee to review researchers'

>proposals to use VSD data, monitor adherence to protocols, and advise

>the agency and its partners on when and how to release preliminary

>findings based on the data, the report says. In addition, CDC should

>create a new subcommittee of the National Vaccine Advisory Committee

>(NVAC), or tap an existing one, to enable stakeholders to review and

>provide input on the VSD research plan every year.

>

> " Concerns about access and transparency have accompanied the development

>and functioning of the Vaccine Safety Datalink data sharing program, and

>consequently some people's trust in the reliability of findings from VSD

>studies has eroded, " explained C. Bailar III, chair of the

>committee that wrote the report and emeritus professor of health studies

>at the University of Chicago. " Taking steps to improve the independence,

>transparency, and fairness of VSD procedures will help enhance

>confidence in the data sharing program and in research based on this

>important tool for evaluating vaccine safety. "

>

>The Vaccine Safety Datalink is a large, linked database of patient

>information that was developed jointly by CDC and several private

>managed care organizations in 1991. It includes data on vaccination

>histories, health outcomes, and characteristics of more than 7 million

>patients of eight participating health organizations. Researchers from

>CDC and the managed care groups have used VSD information to study

>whether health problems are associated with vaccinations. The subsequent

>VSD data sharing program was launched in 2002 to allow independent,

>external researchers access to information in the database. Four

>successive versions of guidelines for external researchers who wish to

>use VSD data have been released; the most recent draft is posted in the

>Federal Register with a March 1 deadline for public comment.

>

>Because of certain unique characteristics, the VSD data sharing program

>does not function in the same way that other data sharing programs do.

>In addition to the protections accorded to patient information by

>privacy laws, the participating managed care organizations maintain

>proprietary control over data they have supplied from 2001 onward. This

>means that these data are not available to external researchers working

>independently on most types of studies. Even so, because the VSD is a

>tax-supported public resource used to inform health policy decisions,

>the public deserves access to the data that influence such decisions,

>the report says; the public also is entitled to transparency and

>independence in the processes that permit or restrict access. The

>committee concluded that it is possible to facilitate public access and

>transparency while also protecting patient privacy.

>

>The public should be involved in setting priorities for VSD research,

>given the controls placed on information available through the VSD data

>sharing program, the report says. To that end, a subcommittee of NVAC

>with representation from a wide variety of stakeholders -- from vaccine

>manufacturers to federal agencies to advocacy groups -- should provide

>feedback and input on the program's research plan each year. Although

>such a group would inevitably have biases and conflicts of interest, it

>is important that VSD officials hear from all interested individuals. To

>promote transparency, the subcommittee's deliberations should take place

>in open meetings.

>

>A separate, independent committee should review research proposals to

>use VSD data to ensure that they meet the criteria for access. In the

>interest of fairness and openness, CDC needs to spell out more clearly

>these criteria, among which the technical feasibility of the proposal

>should be paramount, the report added. The committee also should oversee

>changes in research protocols for VSD studies conducted by researchers

>from CDC or the managed care groups. Members of this independent review

>committee should be chosen on the basis of their scientific and

>technical expertise and their lack of conflicts of interest or biases,

>or CDC's ability to balance these.

>

>Another key function of the independent review committee should be to

>counsel VSD scientists and officials on when and how to release

>preliminary findings from studies based on VSD data. In some instances,

>public disclosure of preliminary findings based on incomplete data or

>analyses that have not undergone external peer review may be necessary

>to protect the public's health and safety. But early release can lessen

>people's confidence in the final results of a study if further data

>collection and analysis lead to different final conclusions. In nearly

>all situations, preliminary findings should undergo independent,

>external peer review before they are shared with the public or used as

>the basis of policy decisions, the report says.

>

>Given that the managed care organizations maintain proprietary control

>over data collected beginning in 2001, independent, external researchers

>will have to collaborate with a partner from CDC or one of the health

>groups to gain access to these data. Although it is impossible to make

>collaboration mandatory, CDC should require each participating managed

>care group to designate an individual whose role is to facilitate and

>encourage partnerships.

>

>Because any breach of patient data confidentiality could discourage the

>managed care groups from participating, CDC should make certain that its

>rules for addressing confidentiality violations are clearly spelled out

>in the program* *guidelines and agreement forms, the report says. In

>addition, the committee concluded that it is reasonable to expect

>independent, outside researchers to provide VSD officials with status

>reports on their studies. When scientists have findings ready for public

>release, they should be required to provide CDC copies of any

>manuscripts at least 30 days before submission for publication and

>copies of presentations to be given at public events at least 15 days in

>advance.

>

>The study was sponsored by Centers for Disease Control and Prevention.

>The Institute of Medicine is a private, nonprofit institution that

>provides health policy advice under a congressional charter granted to

>the National Academy of Sciences. A committee roster follows.

>

>Pre-publication copies of *_Vaccine Safety Research, Data Access, and

>Public Trust_*

><http://books.nap.edu/catalog/11234.html?onpi_newsdoc02172005>* *are

>available from the National Academies Press; tel. 202-334-3313 or

>1-800-624-6242 or on the Internet at *_http://www.nap.edu_*

><http://books.nap.edu/>. Reporters may obtain a copy from the Office of

>News and Public Information (contacts listed above).

>

>[ This news release and report are available at

>*http://national-academies.org <http://national-academies.org/> *]

>

>INSTITUTE OF MEDICINE

>Board on Population Health and Public Health Practice

>

>*Committee on the Review of the National Immunization Program's *

>*Research Procedures and Data Sharing Program*

>

>* C. Bailar III, M.D., Ph.D. (chair)*

>Professor Emeritus

>Department of Health Studies

>University of Chicago

>Washington, D.C.

>

>*Garnet L. , Ph.D.*

>Co-Principal Investigator

>Women's Health Initiative Clinical Coordinating Center

>Fred Hutchinson Cancer Research Center

>Seattle

>

>* E. Fienberg, Ph.D.*

>Maurice Falk University Professor of Statistics and

>Social Science

>Carnegie Mellon University

>Pittsburgh

>

>*Debra R. Lappin, J.D.*

>Senior Adviser

>Public Health and Life Sciences Consulting

>B & D Sagamore

>Washington, D.C.

>

>*Mryon M. Levine, M.D., D.T.P.H.*

>Professor and Director

>Center for Vaccine Development

>School of Medicine

>University of land

>Baltimore

>

>* C. Mastroianni, J.D. M.P.H.*

>Assistant Professor

>School of Law and Institute for Public Health Genetics

>University of Washington

>Seattle

>

>*Colin L. Soskolne, Ph.D.*

>Professor

>Department of Public Health Sciences

>University of Alberta

>Edmonton, Alberta

>Canada

>

>*Elaine Vaughan, Ph.D.*

>Associate Professor

>Department of Psychology and Social Behavior

>School of Social Ecology

>University of California

>Irvine

>

>INSTITUTE STAFF

>

>* Pernack Anason, M.P.H.*

>Study Director

>

February 17, 2005

Why don't they just put the data on-line like everybody's suppose to? If Eli

Lilly and Merck can find my hat size by analyzing internet data I should be able

to get the goods on vaccines at the click of a mouse.

If vaccine adverse reaction out-comes safety data has to be some sort of a

anti-bioterrorism secret, what does that tell you about the vaccines? Do they

actually think that Al Qeada will come at Americans wielding syringes of Hep B

vaccines or something?

[ ] IOM Report on Vaccine Safety Oversight Released