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Federal Vaccine Data Should Be Available to the Public

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.

If you would like to review the proposed changes yourself, you may link to http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a110.html

Here is PROVE's Letter of Opposition to these changes.

September 7, 1999

To: F. James Charney, Policy Analyst
Office of Management and Budget
grants@omb.eop.gov
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

 
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