The issue at stake is the ability for the public to have access to the data produced by
federally-funded research. Even though Congress inserted an amendment into a law last fall to
guarantee the public this right through FOIA, the Office of Management and Budget (OMB) is using the
rulemaking/regulatory process to attempt to circumvent this intent by restricting access in certain
instances. These proposed OMB changes would effectively remove all federally-funded vaccine research
from public access. Thanks to some great alerts by Citizens' Council on Health Care and the Eagle
Forum, we were able to draft this letter of opposition concentrating specifically on the vaccine
issue.
Here is PROVE's Letter of Opposition to these changes.
September 7, 1999
To: F. James Charney, Policy Analyst
Office of Management and Budget
[email protected]
Room 6025 New Executive Office Building
Washington, DC 20503
Subject: Comments in Opposition to the Proposed Revision of OMB Circular A-110
Dear Mr. Charney:
Parents Requesting Open Vaccine Education (PROVE) responds to the OMB request for public
comments on 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."
PROVE is a grassroots organization of parents, health care providers, and state legislators who
monitor state and federal immunization policies and practices that affect the children and adults
of Texas. Our mission is to prevent vaccine injury and death and to promote and protect the right
of every person to make informed independent vaccination decisions for themselves and their
families.
In this regard, PROVE fully supports the Shelby amendment to P.L. 105-277, which requires that
"all data produced under an award will be made available to the public through [FOIA],"
and we respectfully insist that you reconsider your proposed changes to OMB Circular A-110 as we
assert that these changes and interpretations of definitions, if implemented, would circumvent the
true spirit of the intent of the law. All citizens of the United States of America should have
their rights protected to make fully informed independent medical decisions, including decisions
about vaccinations. These proposed changes would limit the public's ability to draw their own
conclusions from data produced by federally-funded research used to institute federal vaccine
policy, and we respectfully request that these proposed changes be withdrawn.
PROPOSED INTERPRETATION OF THE WORD "DATA"
Senators Shelby, Lott, and Campbell succinctly clarified their intent "[if]
federally-funded pre-published data or findings are used to support a federal policy or rule, then
the final revision should ensure that such data would also be made publicly available under FOIA.
If the data are sufficiently sound to support a federal policy or rule, then they should be able
to bear public scrutiny and disclosure...This point is critical to ensuring that our federal rules
and policies are based on good science and research findings."
However, OMB's proposed changes would allow recipients of federal funds to withhold research
data based on THEIR determination that such data constitute "trade secrets, commercial
information, materials necessary to be held confidential by a researcher until publication of
their results in a peer-reviewed journal, or information which may be copyrighted or
patented." The statute guarantees the public the right to have access to data outside of the
(narrower) FOIA exemptions, and neither the recipients nor agencies should have discretion to
conceal data beyond the existing and sufficient FOIA exemptions.
OMB's proposed exemptions would result in the blocking of public access to data used to make
federal vaccine recommendations. Because federal policy regarding vaccines is translated into
state laws mandating that the medical procedure of immunization be performed on private citizens
while ignoring their right to informed consent, vaccine safety, efficacy, and necessity data
should never be exempted from the public for any reason. OMB's proposal constitutes a deliberate
violation of P.L. 105-277 which results in the endangerment of public health.
PROPOSED INTERPRETATION OF THE WORD "PUBLISHED"
OMB's proposal to define "published" research findings as "either when (A)
research findings are published in a peer-reviewed scientific or technical journal, or (B) a
federal agency publicly and officially cites to the research findings in support of an agency
action" is too narrow and creates a loophole which will be used to deny the statutorily
guaranteed public access to "ALL data produced under an award."
Sometimes, a federal agency jumps to a policy decision without adequate research to support
their actions. Without access to ALL data, the public may never know how poorly scientifically
supported a policy may be. When this is the case, it is most likely that the data would not be
published in a peer-reviewed journal or be officially cited because it may not even exist. This
restriction gives government employees involved in irresponsible public health policy a rock to
hide under.
Here is a specific example where this definition would shield a Government agency from
accountability for bad policy. The Rotavirus vaccine, which was developed by National Institutes
of Health researchers, was recommended for universal use in infants to aid in the prevention of
diarrhea by the CDC's Advisory Committee on Immunization Practices (ACIP) six months before the
vaccine was even licensed by the Food and Drug Administration on August 31, 1998. In this real
life example, the CDC didn't cite full research findings in support of their policy because the
FDA wasn't even done with their assessment of the safety and efficacy of the vaccine. Meanwhile,
one year later, the recommendation was rescinded because of a high incidence of a life threatening
side effect in infants given the vaccine. The CDC needs to be held responsible for their
inadequate assessment of risk and premature universal recommendation, but if this definition were
in place, the public would have very limited ability to fully investigate this public health
fiasco.
PROPOSED REPLACEMENT OF THE PHRASE "USED BY THE FEDERAL GOVERNMENT IN DEVELOPING POLICY OR
RULES" WITH "USED BY THE FEDERAL GOVERNMENT IN DEVELOPING A REGULATION."
OMB's proposed replacement to limit public access to research data concerning findings
"used by the federal government in developing a [formal] regulation" flouts the will of
Congress. Our lawmakers who supported the Shelby amendment did so under the intention that it
would give the public access to ALL data used by the federal government to influence, encourage,
or regulate American Citizens, directly or indirectly. OMB appears to be acting outside the realm
of its authority in its attempt to redefine the intent of Congress.
Under this provision, any data (or lack thereof) relating to federal vaccine usage
recommendations, would be exempt from public access because it wouldn't be used to implement a
formal federal regulation. As stated above, most states take these federal vaccine recommendations
and translate them into inflexible state laws and regulations which even deny a child access to a
public education unless the child has every dose of every vaccine. Some state statutes even
require the state board of health to adopt state regulations requiring vaccines to be administered
in accordance with federal CDC recommendations removing the public even further from the
legislative process.
Congress insightfully acknowledged that federal government policy has far reaching consequences
on state and local government in many areas, and therefore placed no statutory limitations on the
access to data. OMB's assessment that the public interest would not be served by extending the
provision contained in P.L. 105-277 beyond federal regulations is short sighted and fails to
acknowledge the tremendous influence federal policy and rules have on states.
One recent example of where this redefinition would have tremendously disserved the public
interest is in regard to the CDC's policy to universally recommend that all children have the
hepatitis B vaccine prior to attending school. Even though this is not a federal regulation, over
40 states have fallen in line with the CDC recommendation and have implemented this into a legal
requirement. Thanks to public information requests, consumer advocacy groups were able to learn
that there were far more reports of severe injuries and deaths following the administration of the
vaccine in young children to a federal vaccine safety database than there were cases of the
disease reported to the CDC in children in the same age group. More FOIA requests enabled
journalists and consumer advocacy groups to review the adverse events reported by more than 24,000
Americans following the administration of the hepatitis B vaccine. These events prompted the
Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government
Reform in the U.S. House of Representatives to hold a hearing on May 18, 1999 to investigate this
issue further. OMB's proposed definition change would make it impossible for the public to have
access to the data to question this federal universal vaccine recommendation policy.
PROPOSED $100 MILLION IMPACT THRESHOLD
Nowhere in the statute is public access limited according to an impact assessment. The data
should be made available regardless of the dollar figure attached to the impact, which in the
majority of instances would be an arbitrary assessment depending on the analyst's perspective.
This limitation provides an unacceptable loophole through which agencies and researchers may
escape public scrutiny and accountability.
This is particularly true for vaccine policy, where the CDC asserts that adverse reactions only
affect a small number of recipients. That should in no way exempt the CDC and the FDA from
providing the safety and adverse reaction data to justify their decisions. This is particularly
important to families filing vaccine injury compensation claims with the federal government. It is
additionally very important in areas where adequate studies have not been completed to justify a
policy, so the true financial impact will not be known. For example, on almost every
manufacturers' vaccine product package insert, it clearly states that the vaccine has NOT been
evaluated for it's carcinogenic or mutagenic potential or for it's ability to impair fertility. In
many cases where a federally regulated product is implicated as a causal or triggering factor in
one's injury or death, the true financial impact may not be known until the data used to formulate
government policy is analyzed by outside sources and more independent studies are conducted.
PROPOSED COST REIMBURSEMENT
If federal agencies are allowed to tack on layers of fees in addition to a Freedom of
Information Act (FOIA) fee, then this may in itself impede public access by making the process
cost prohibitive to most individuals. With the advancement of computer and Internet technology,
there is no reason why OMB shouldn't require a federal agency which funds the research to publish
all the data before changing or setting a policy, and especially before the start of a public
comment period. If the agency streamlined their process using computer technology towards the true
intention of public accountability, extraneous fees would not be necessary. While it is
understandable that federal agencies may be impacted and need some compensation until these
changes are implemented, what is considered a reasonable fee to a family who is struggling to pay
the medical bills of a vaccine injured child may not be considered reasonable by the agency asked
to provide data which could be self-incriminating. It is incumbent upon OMB to take all steps
necessary to ensure that fees won't be used to create a barrier between the public and data.
CONCLUSION
We respectfully insist that the clear statutory intent of P.L. 105-277 be fully implemented. We
assert that these proposed changes and interpretations of definitions, if implemented, would
circumvent the true spirit of the intent of the law and would be a disservice to the public.
Sincerely,
Dawn Richardson, president PROVE
