Analysis of S. 1873 - The Biodefense and Pandemic Vaccine and Drug Development Act of 2005

Karen R. Effrem, MD

Alliance for Human Research Protection Board of Directors
www.ahrp.org

INTRODUCTION: This bill seriously endangers, if not completely undermines, the democratic process and the rule of law. It will absolutely destroy the unalienable rights of trial by jury and informed consent. It is a radical transfer of the US Treasury into the hands of unaccountable private companies whose record shows far more concern about profits than in protecting and improving the health of the American people. It also concentrates the power of life and death in the hands of one very fallible human being and creates an unaccountable federal bureaucracy not subject to disclosure, independent oversight or the safeguards of accountability necessary in a free republic. Why, when the risk of animal to human viral transfer is speculative[1], would Congress and the American people want to abdicate their duty to uphold the Constitution and unalienable rights, respectively, to an agency and private entities that have made so many mistakes? These mistakes include poor public health and pandemic judgment (SARS and swine flu); ineffective vaccines (correct strain of influenza every seven years; influenza vaccine does not work in elderly,[2] [3] young children,[4] and even healthy adults[5]); and unsafe vaccines (injuries and deaths from swine flu vaccine and contamination), not to mention killing and injuring thousands with dangerous and ineffective drugs? S 1873 needs to be completely rejected by the US Congress.

1)     S. 1873 provides total immunity from liability for manufacturers of drugs and vaccines. This will remove any requirement for the pharmaceutical industry to provide safe and effective vaccines or drugs, when their record on safety, effectiveness, and open disclosure of study and clinical trial data to physicians and the public is abysmal. The game is completely rigged against individual citizens and an enormous amount of tyrannical power is concentrated in the hands of one person. Lord Acton's saying that 'power corrupts and absolute power corrupts absolutely' applies here in spades.

• Any vaccine or drug used during a public health emergency, the declaration of which is solely determined and defined by the Secretary of Health and Human Services (HHS), and even if contaminated during manufacturing or distribution, as is often the case,[6] [7] is exempt from a liability trial by jury. [Sec. 6(b)(1)(A)(i)]

  IN GENERAL- No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure or qualified pandemic or epidemic product distributed, sold, purchased, donated, dispensed, prescribed, administered, or used in anticipation of and preparation for, in defense against, or in response to, or recovery from an actual or potential public health emergency that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary in a declaration described in paragraph (2).

• 'Manufacturer' is broadly defined so as to give immunity from liability to anyone involved with the process of drug or vaccine development or distribution. [Sec. 6(d)(4)]

  MANUFACTURER- The term `manufacturer' includes-`(A) a contractor or subcontractor of a manufacturer; `(B) a supplier of any product or service, research tool, or component to the manufacturer; and`(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

• The Secretary has the sole discretion to decide what constitutes a 'qualified pandemic product,' which may be done absent any clinical trial data, and if the Secretary thinks it will be approved within 8 years of the designation. [Sec. 6(d)(5)(B)]

  'Is a product for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the product will qualify for approval or licensing within 8 years after the date the Secretary makes a declaration under paragraph (2);' (Emphasis added)

• The only remedy an American citizen harmed by experimental drugs or vaccines mandated by the Secretary of HHS in a public health emergency that is defined only by that Secretary [Sec. 6(b)(2)] is to appeal to that same person for redress of grievances [Sec. 6(b)(1)(C)].
  
  
• The Secretary must then have proof that the manufacturer a) Violated the Food, Drug, and Cosmetics Act and b) Was involved in willful misconduct. [Sec. 6(b)(1)(D)(i)]

  IN GENERAL- In making a determination under this subparagraph, the Secretary, acting through an administrative law judge, must find clear and convincing evidence that--`(I) the manufacturer, distributor, administrator, or health care provider violated a provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or this Act; and`(II) in violating such Act, such manufacturer, distributor, administrator, or health care provider acted with willful misconduct. `(ii) EFFECT OF DETERMINATION- If the Secretary finds such clear and convincing evidence under clause (i), the Secretary shall examine whether such willful misconduct to violate an Act under such clause--`(I) caused the product to present a significant or unreasonable risk to human health; and (II) proximately caused the injury alleged by the party.'

• It is solely up to the Secretary to decide and promulgate regulations on what constitutes 'willful misconduct.' [Sec. 6(b)(1)(D)(v)]

  (vi) REGULATORY AUTHORITY- The Secretary, in consultation with the Attorney General, shall promulgate regulations defining what actions by a manufacturer, distributor, administrator, or health care provider of a security countermeasure or a qualified pandemic and epidemic product shall be deemed to constitute `willful misconduct' for purposes of clause (i). In promulgating such regulations, the Secretary shall consider the nature of the actual or potential public health emergency, the timing and extent of any vaccination or countermeasure program, and any other circumstances they deem significant, so that any civil actions permitted under this subsection will not adversely affect the public health. The Secretary may specify the period of time for which such regulations apply.'

• The Secretary who has all of this power must also believe that the injury occurred as a result of the drug or vaccine and due to this willful misconduct on the part of the vaccine manufacturer. [Sec. 6 (b)(1)(D)(vii)] Given that the CDC admits that only 1-10% of adverse vaccine reactions are reported and the horrific track record of the National Vaccine Injury Compensation Act that turns 2 out of 3 petitioners away and actively fights against the families of vaccine injured children that do get into the system, how likely is any of this to happen?

  (vii) EVIDENCE REQUIRED- The Secretary, in consultation with the Attorney General, shall promulgate regulations that require, in order to be a party under this section, that an individual present evidence that reasonably demonstrates that-- `(I) such individual has suffered a loss as a direct result of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, or administration of a security countermeasure or qualified epidemic or pandemic product; and `(II) the loss as described in subclause (I) was a direct result of the willful misconduct of the manufacturer, distributor, administrator, or health care provider in violating the Federal Food, Drug, and Cosmetic Act or this Act.

• Individual citizens do not have the right of judicial review if they are turned down by this Orwellian system, but the manufacturers of the vaccines do have a full right to hearing and to judicial review. [Sec. 6(b)(1)(D)(ii & iv)]

  (ii) NOTICE AND HEARING- Prior to the Secretary's making a determination under clause (i), the manufacturer, distributor, administrator, or health care provider shall have notice and a right to a formal hearing in accordance with section 556 of title 5, United States Code.

  (iv) JUDICIAL REVIEW- At any time prior to the 90th day following a determination by the Secretary under clause (i), any manufacturer, distributor, administrator, or health care provider named in such determination may file a petition with the United States Court District Court for the District of Columbia, for a judicial review of such determination. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by the Secretary for that purpose. The Secretary thereupon shall file in the court the record of the findings on which the Secretary based his or her determination. The filing of a petition under this clause shall automatically stay the Secretary's determination for the duration of the judicial proceeding. The sole parties to the judicial proceeding shall be the Secretary and the petitioner. Intervention by third parties in the judicial proceeding shall not be permitted. No subpoenas shall be issued nor shall other compulsory process apply. The court's review of a determination by the Secretary under this clause shall conform to the procedures for judicial review of administrative orders set forth in paragraphs (2) through (6) of section 701(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(f)) to the extent consistent with this section.

2)     In addition to being immune from liability and having their products mandated in a public health emergency, the drug and vaccine manufacturers will also be receiving what could total billions of dollars in rebates and grants paid for by US citizens that have no recourse when injured or killed by their products. (Sec. 8)

3)     Establishes an unaccountable federal vaccine bureaucracy called the Biomedical Research and Advanced Development Agency (BARDA - Sec. 3):

• If a consumer or large numbers of the public are harmed by a vaccine or product developed by BARDA, there is no way to find out what the ingredients of the vaccines or drug are. Everything is veiled in secrecy by exempting BARDA from The Freedom of Information Act without possibility of judicial review. [Sec. 3(f)(2)]

  'FOIA- Information that relates to the activities, working groups, and advisory boards of the BARDA shall not be subject to disclosure under section 552 of title 5, United States Code, unless the Secretary or Director determines that such disclosure would pose no threat to national security. Such a determination shall not be subject to judicial review.'

• The meetings of this organization are not subject to open meeting laws. [Sec. 3(f)(1)]

  'FACA- The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the duties, activities, working groups, and advisory boards of the BARDA.

• There is no financial accountability for the use of BILLIONS of tax dollars to develop and mandate the use of highly experimental drugs and vaccines of unproven safety and efficacy. [Sec. 3(f)(3)]

  'CERTAIN COST PRINCIPLES AND COST ACCOUNTING STANDARDS- Notwithstanding any other provision of law, the cost principles set forth under part 31 of title 48, Code of Federal Regulations, the cost accounting standards set forth under chapter 99 of title 48, Code of Federal Regulations, and the requirement for the submission of certified cost and pricing information under section 304A of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254b), shall not apply to any contract, grant, cooperative agreement, or other transaction entered into under the Project BioShield Act of 2004 (Public Law 108-276).'

• There is not even one token consumer representative among the appointed membership of the Advisory Board [Sec. 319L(c)(1)(B)(ii)]:

  'MEMBERS. - The following individuals, as appointed by the Secretary: (I) Four representatives of the pharmaceutical, biotechnology, and device industries. (II) Four representatives of academia. (III) Five other members as determined appropriate by the Secretary.'

• The law does not say that consumers have to be involved, only that 'The Director may establish and convene one or more working groups composed of private citizens and officials of Federal, State, and local governments to advise such Director with respect to the functions of the BARDA and the Director.' [Sec. 319L(b)(6)(B)]

4)     Health care workers but not individual citizens are covered in the case of injury or death as a result of use by a 'qualified pandemic product.' (Sec.7)

References:

[1] AHRP (11/5/05) European perspective: Bird Flu--BBC Panoarama / German skeptics / Rumsfeld Tamiflu stock $5 to $25 million http://www.ahrp.org/infomail/05/11/05.php

[2] THE FLU VACCINE: What You Should Know. A Special Report by the Think Twice Global Vaccine Institute. http://thinktwice.com/flu_lie.htm

[3] Associated Press (9/22/05) Flu shots not as effective in elderly as thought Officials still urging vaccinations for people over 65 http://msnbc.msn.com/id/9438511/

[4] (4/26/05) No Evidence of Benefit from Flu Shots in Children Under 2 Journal Watch Dermatology, Vol. 2005, Issue 426, 9

[5] Demicheli V, Rivetti D, Deeks JJ, Jefferson TO. (2004) Vaccines for preventing influenza in healthy adults. In: The Cochrane Library; Issue 3, Oxford: Update Software

[6] Martin Bright and Antony Barnett Revealed: full scale of vaccine blunders US authorities horrified by conditions at factory in BSE-tainted polio drug scare, The Observer (UK) Sunday October 22, 2000 http://www.observer.co.uk/uk_news/story/0,6903,386177,00.html and http://www.whale.to/vaccines/bse3.html

[7] Peterson, J. and Gellene, D. (11/18/04) Contamination widespread at flu vaccine plant Chiron's ability to produce shots for 2005 is questioned Los Angeles Times http://www.baltimoresun.com/news/health/bal-te.flu18nov18,1,461072.story?coll=bal-health-storyutil