CLARIFYING CHANGES TO PROPOSED REVISION ON PUBLIC ACCESS TO RESEARCH DATA

[Guest guest]

National Vaccine Information Center wrote:

From: The National Vaccine Information Center

512 W. Maple Avenue, #206

Vienna, VA 22180

(703) 938-0342

September 9, 1999

F. Charney, Policy Analyst

Office of Management and Budget

Room 6025

New Executive Office Building

Washington, D.C. 20503

By E-Mail: grants@...

Re: Clarifying Changes to Proposed Revision on Public Access to Research

Data, OMB Circular A-110

Dear Mr. Charney:

On behalf of the membership of the National Vaccine Information Center

(NVIC), I write to oppose the clarifying changes to the proposed revision

of

OMB Circular A-110, " Uniform Administrative Requirements for Grants and

Agreements with Institutions of Higher Education, Hospitals, and Other

Non-Profit Organizations " .

NVIC is a national, nonprofit educational organization founded in 1982 and

dedicated to the prevention of vaccine injuries and deaths through public

education. The organization provides assistance to parents whose children

have suffered vaccine reactions; conducts and promotes research to evaluate

vaccine safety and effectiveness as well as to identify factors which place

individuals at high risk for suffering vaccine reactions; and monitors

federal and state vaccine research, development, regulation, policymaking

and legislation. NVIC supports the right of citizens to exercise informed

consent when making educated vaccination decisions for themselves and their

children.

As currently drafted, the clarifying changes to the proposed revision on

public access to research data will severely limit the ability of

individuals, parents and guardians to assess the risks and benefits

associated with vaccination, and to exercise informed consent in any

meaningful way with respect to the vaccination of themselves or their

children. NVIC respectfully insists that OMB adhere to the spirit and

intent of the Congressional directive in P.L. 105-277 to amend Circular

A-110 " to require Federal awarding agencies to ensure that all data

produced

under an award will be made available to the public through procedures

established under the Freedom of Information Act. "

Proposed Clarification of the Term " Data "

By eliminating preliminary analyses, drafts of scientific papers, plans for

future research, peer reviews and communications with colleagues from the

definition of " data " and access through FOIA, OMB effectively eliminates

the

public's ability to monitor federal agency compliance with public law

requiring ongoing engagement in vaccine safety initiatives.

For example, Section 2127 of the Public Health Service Act (P.L. 99-660)

requires the Secretary of the Department of Health and Human Services to:

(1) Promote the development of childhood vaccines that result in fewer and

less serious adverse reactions than those vaccines on the market...and

promote the refinement of such vaccines; and

(2) make or assure improvements in, and otherwise use the authorities of

the

Secretary with respect to, the licensing, manufacturing, processing,

testing, labeling, warning, use instructions, distribution, storage,

administration, field surveillance, adverse reaction reporting, and recall

of reactogenic lots or batches of vaccines, and research on vaccines, in

order to reduce the risks of adverse reactions to vaccines.

" Research data " is collected throughout this complex development and

monitoring process, but little of it would be characterized as " data " , and

therefore subject to FOIA, under the currently proposed definition of the

term as " the recorded factual material commonly accepted in the scientific

community as necessary to validate researching findings. " The Institute of

Medicine, National Academy of Sciences, has identified significant gaps in

current knowledge about the safety of vaccines precisely because there is

so

little " data " as data is defined in the proposed clarification (see

Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella

Vaccines. Washington, DC: National Academy Press; and Institute of

Medicine. 1994. Adverse Effects Associated with Childhood Vaccines:

Evidence

Bearing on Causality. Washington, DC: National Academy Press).

Much of this narrowly defined " research data " is held by the vaccine

industry and unavailable to the general public as confirmed by the Task

Force on Safer Childhood Vaccines, National Institute of Allergy and

Infectious Diseases, National Institutes of Health in their Final Report

and

Recommendations, January 1998:

" The vaccine industry, comprising the major vaccine manufacturers as well

as

biotechnology companies, sponsors or conducts a significant amount of

vaccine research. However, because its results are not always published

and

its financial records are confidential, the extent of this commitment can

only be estimated. "

On occasions when federally funded scientific vaccine safety studies are

conducted, they are frequently conducted extramurally, although the

proposed

revisions suggest that FOIA restrictions might apply to intramural research

as well. The supplementary information section of OMB's " request for

comments " documents states: " Therefore, the proposed revision will affect

the full range of research activities funded by the Federal Government. "

Vaccine schedules and policy recommendations often evolve from a

combination

of intramural and extramural research findings. NVIC has been able to

access both intramural and extramural research data through the FOIA

process

to date in order to monitor federal and state vaccine research,

development,

regulation, policymaking and legislation.

The American public is often left to glean what it can of vaccine safety

developments from documents generated in the course of publicly funded

" research " . At a minimum, it is imperative that the public retain access,

through the FOIA process, to essentially all vaccine data generated through

the use of public funds, including material contained in " preliminary

analyses, drafts of scientific papers, plans for future research, peer

reviews or communications with colleagues. "

At a minimum, we respectfully insist, it is the federal government's

responsibility to ensure that the American public retains the independent

means to monitor public agencies charged with the responsibility for

vaccine

research, development, licensing, regulations, policymaking and promotion.

It is the federal government's responsibility to ensure the continuing

free-flow of information required for the exercise of informed consent to

the mandatory use of government-endorsed biological products which carry a

risk of injury or death, in this case, viral and bacterial vaccines. The

fact that federal agencies promote the mandatory use of vaccines by all

citizens makes the obtaining of vaccine safety and effectiveness data

through FOIA critical to ensuring the integrity of the mass vaccination

system.

NVIC supports a broad interpretation of the term " data " , excluding only

existing FOIA exemptions including personal medical records " and similar

files the disclosure of which would constitute a clearly unwarranted

invasion of personal privacy " from data subject to a FOIA request.

Proposed Clarification of the Term " Published "

By defining the term " published " as " either when (A) research findings are

published in a peer-reviewed scientific or technical journal, or ( a

Federal agency publicly and officially cites to the research findings in

support of a regulation " , OMB would remove from FOIA access most

significant

vaccine data currently available to the American public.

For example, vaccination schedules in this country are not established or

enforced by federal regulation. The schedules develop from recommendations

issued by the federal Advisory Committee on Immunization Practices of the

Center for Disease Control (CDC) and the private American Academy of

Pediatrics (AAP), recommendations which are then legally adopted, mandated,

and enforced at the state level. As the term " published " is currently

defined, data supporting federal vaccine usage recommendations, and the

revision of these recommendations, would no longer be available to the

American public unless related findings were published in a peer-reviewed

scientific or technical journal.

As commenters have previously indicated to OMB, this requirement would

create an untenable situation for the public on occasions when researchers

declined to publish in peer reviewed journals, and when the government

relied upon data which had not been peer reviewed to make federal vaccine

policy. Parents, physicians and other concerned citizens would be deprived

of the means to independently evaluate federal vaccine usage

recommendations

and schedules as the term " published " is currently defined.

In another example, the Vaccine Adverse Event Reporting System (VAERS)

serves as the principal postlicensure surveillance mechanism in the vaccine

safety continuum. While the raw data collected has, on occasion,

influenced

a change in vaccine policy, findings developed from the data are rarely

published in peer reviewed journals, and rarely " provid[e] any basis for

regulatory action. " (Testimony of Dr. Ellenberg, Director of

Biostatistics and Epidemiology Division, Food and Drug Administration,

before the House Subcommittee on Criminal Justice, Drug Policy and Human

Resources, May 18, 1999.) VAERS data are currently made available to the

public, through the FOIA process, for independent research and review. As

the term " published " is currently defined, this rich and critical source of

vaccine outcome data might be removed from public purview.

In the 1980's, FOIA requests regarding federal funding and conducting of

intramural and extramural medical research into the adverse effects

associated with the DPT vaccine produced information critical to public

understanding of the need for a safer pertussis vaccine. This knowledge

contributed to the development of the National Childhood Vaccine Injury Act

of 1986 and ultimately resulted in the FDA licensing of a safer pertussis

vaccine (DtaP) in 1996.

In the 1990's, FOIA requests regarding federal funding and conducting of

intramural and extramural medical research into the effects of a high

potency EZ measles vaccine produced information critical to public

understanding of informed consent and other ethics violations which

occurred

during that study. This knowledge resulted in acknowledgement by DHHS of

the importance of protecting informed consent rights of participants in

medical experiments.

A pending FOIA request filed by NVIC with FDA and CDC in May 1999 regarding

scientific data, derived from both intramural and extramural research, on

the safety of the hepatitis B vaccine would be jeopardized by the proposed

OMB changes. These FOIAs are part of NVIC's testimony at a May 18, 1999

hearing before the U.S. House Subcommittee on Criminal Justice, Drug Policy

and Human Resources investigating reports of adverse effects associated

with

hepatitis B vaccine.

The ability of the public to access critical scientific information which

DHHS uses to buttress their arguments regarding the safety of mandatory

vaccination policies is fatally compromised by the OMB revisions. The

current OMB definition would also shield publicly supported researchers and

agency representatives from accountability when seeking to shape public

opinion and public policy regarding vaccination. Through federal agency

citation of studies unavailable to the public in Congressional hearing

rooms

and the issuance of information materials which purport to educate and yet

leave the public without the means to evaluate, the prospects for

malfeasance are enormous.

NVIC supports a broad interpretation of the term " published " , including but

not limited to when a researcher or the sponsoring agency cites data in any

forum open to public, and when data have been otherwise made available to

the public by the sponsoring agency or its representative through any

public

document used to educate, solicit cooperation or advance the agency

mission.

Proposed Clarification of the Phrase " Used by the Federal Government in

Developing Policy or Rules "

The National Vaccine Information Center supports the interpretation of

" policy or rules " proposed by former commenters to OMB where " 'policy or

rules' would include such things as agency guidance, surveys, risk

assessments and reports, and 'used' would refer to when the agency first

relies internally on the findings. " NVIC also supports the view of a

former

commenter that " all data adverse to the position of a party impacted by

regulatory action should be susceptible [to] honest scrutiny " , although we

would add to this statement " or adversely affected by federal policy " to

more accurately reflect the full range of possible adverse impact.

OMB's tortured interpretation of the phrase " policy or rules " to indicate

circumstances " when an agency publicly and officially cites to the research

findings in support of a regulation (for which notice and comment is

required under 5 U.S.C. 553) " flies in the face of Congressional intent to

make federally funded research data more accessible to the American public.

The rhetoric used to justify this interpretation is duplicitous and the

criteria used to develop this interpretation insupportable.

Congressional proponents have made their intentions clear with respect to

the amendment of Circular A-110: the new language must " require Federal

awarding agencies to ensure that all research results, including underlying

research data, funded by the Federal Government are made available to the

public through procedures established under the Freedom of Information

Act. "

The provision's sponsors did not qualify or exclude from FOIA access

inquiries which might be " burdensome and time-consuming " , leaving only

those

" readily and easily " responded to. Furthermore, OMB is patently incorrect

in its assessment that there is " lesser public interest in obtaining the

underlying research data when the agency is not taking action that has the

force and effect of law. "

As previously indicated, the National Vaccine Initiative is advanced

through

the development and dissemination of policy, not regulation. The American

public would be deprived of the means to access vaccine safety and efficacy

data, including risk assessment documents, as this phrase is currently

defined.

NVIC supports a broad and generous interpretation of the phrase " used by

the

Federal Government in developing policy and rules " , and rejects OMB's

substitution of language pertaining to regulation as an unauthorized

attempt

to rewrite the language of public law. The further limitation to impact

exceeding a $100 million threshold is also unacceptable.

Proposed Clarification of the Phrase " Cost Reimbursement "

NVIC disagrees with OMB's assessment that the " reasonable fee " should be

considered as separate and apart from the FOIA fee. Reduced fee provisions

available under FOIA where information is deemed to contribute

significantly

to public understanding of the operations and activities of government and

will not primarily serve either individual or organizational commercial

interests should apply to any addition to the standard FOIA fee.

Sincerely,

Barbara Loe Fisher

Co-founder and President