Dear Journalist,

We respectfully direct your immediate attention to the newly introduced “Protecting America in the War on Terror Act of 2005”, US Senate bill number S.3. This falsely named legislation cries out for your close political and legal scrutiny. Under the guise of protecting Americans this bill would undermine processes that are intended to insure vaccine safety while giving pharmaceutical companies an unnecessary legal windfall. As parents of children injured by vaccines we favor vaccination but want assurances that vaccines are safe. Alarmingly, this legislation would completely subvert public surveillance of vaccines and evaluation of vaccine safety.  To further confuse the true intent of S. 3, such Orwellian terminology as epidemic "countermeasures" in referring to vaccines is used in an apparent attempt to mislead the public regarding the future of this country's vaccine policies.

As journalists you will be interested to know, for example, that this bill places severe restrictions on FOIA and will impede your ability to disclose information to the public about drug/vaccine safety, regulation and policy. In light of the recent revelations of suppressed information regarding Vioxx, anti-depressants, and the influenza vaccine, among others, the last thing this country needs is to enable government to "close" more meetings without accountability to the media/public.

Under the guise of “Protecting America in the War on Terror” US Senators Gregg, Frist, and their cosponsors call for many sweeping changes in pharmaceutical product liability, vaccine regulation, policy, research and the Vaccine Injury Compensation Act.  This changes will directly affect those families whose children have suffered adverse vaccine reactions, as well as Gulf War and other veterans who suffered adverse reactions to the multiple vaccines they were given (remember the ill-fated anthrax vaccine and small-pox vaccines).

If enacted, S.3 will create unprecedented liability protection for manufacturers of drugs and vaccines, who already enjoy exceptional legal protection under the National Vaccine Injury Compensation Act. It will completely preempt any state legislation that regulates vaccine safety. Its comprehensive assault on our tort adjudication system poses a far greater threat to infant claimants' rights than the infamous Eli Lilly provision that was slipped into the Homeland Security Act in the dead of night in 2002.   US Senate bill S. 3 would give drug and vaccine makers a complete defense to civil actions if their product has FDA approval.  Worse, given the recent revelations of inadequate FDA surveillance and evaluation of drugs, and domination of the FDA drug approval process by industry, it makes the FDA and not our civil justice system the final arbiter of otherwise meritorious claims. These provisions are “gifts” to the pharmaceutical companies. There is no question that S. 3 is payback to the pharmaceutical industry that gave almost $45 million in campaign contributions for Presidential and Congressional elections since 2002 (

This cleverly crafted legislation includes something nearly every American will understandably want to support:  raising the death gratuity for families of soldiers killed in Iraq from $12,000 to $100,000 and increases other military benefits.  Including an unrelated but popular provision that should stand alone legislatively seeks only to cloud the issues addressed in the major portion of this bill's language.  Every American supports increased benefits for our soldiers and their families and that includes us. As parents and loyal Americans, however, we believe that S. 3 has been carefully crafted to unfairly paint parents who seek justice for vaccine injured children into a political corner. Similar to the legislative sleight of hand employed in the Homeland Security Bill fiasco in 2002 the sponsors of S.3 are manipulating the political process by tying domestic programs affecting every American's health and safety to unrelated "anti-terrorism" programs. In this way they are attempting to make legitimate opposition to S. 3 politically unacceptable.

 We question why politically popular legislation supporting our troops is tied to a bill with far-reaching provisions that affect and the safety of vaccines given to millions of American children. Let's not confuse the issues. We believe that by casting the vaccine safety provisions in the language of fighting terrorism (epidemic "countermeasures" is S.3's new code word for "vaccines"--this is truly Orwellian doublespeak) the American people are being misled about S.3's impact on vaccine safety programs. Let's deal with one thing at a time. Taking away the right of states to protect their citizens from dangerous vaccine components and drugs like Vioxx and Paxil does not translate into protecting our children--from terrorism or anything else. All it does is give control of these matters--vaccines and drugs--to a few powerful people who operate behind closed doors. The vaccine safety provisions are pharma support positions, plain and simple, and are not necessary for bio-terror defense, at least not in this form.

We would like you to pay particular attention to S.3's provision that would preempt any state legislation regulating vaccines or vaccine components, such as Thimerosal (mercury).  Iowa and California have already banned mercury in vaccines. Numerous states including Missouri, Maryland, Minnesota, Nebraska, Pennsylvania, Ohio and Washington  have similar legislation pending. By completely preempting such legislation S. 3 will block states from protecting its citizens from dangerous substances like mercury that should not be injected into children. We find this part of the bill particularly troubling.

Additionally, this bill proposes to take away the rights of states to even warn their citizens about potential injuries attributable to vaccines and drugs such as Vioxx and Paxil.  This does not translate into protecting our children from terrorism.  It does, however, give control of these matters--vaccines and drugs--to a few powerful people who operate behind closed doors. The vaccine provisions have nothing to do with safety or bio-terror defense, but are instead pharma-support positions.

Other parts of S. 3, a 134 page tome, are extremely problematic. I have included a copy of the bill in pdf format for your review. S. 3 will directly countermand parental efforts to protect children from vaccine injuries. We believe it does little to protect our nation from terrorism, and that terror protection should not be unfairly tied to questions of vaccine safety and justice for the vaccine-injured.

Recognizing the media's attention would be diverted to Iraqi elections and other issues; this bill is being “fast-tracked” and is already on the agenda at the National Vaccine Advisory Committee meeting, scheduled for February 8, 2005 at 10:45 am:

If this bill concerns you as much as it worries parents and many members of the medical community, please use the power of the media to notify the American public of this bill.  S. 3 is not an anti-terrorism bill--it is an example of Federal power gone wild. Our country deserves better, both for the fight against terror, and to make vaccines safe for our children. 


Lujene G. Clark
Alan D. Clark, M.D.
(417) 358-2331

Bobbie Manning
(716) 636-1138 

Rita Shreffler
(417) 725-6107


`(a) IN GENERAL- Except as provided in section 763, no State, political subdivision of a State, or judicial system of a State may establish or continue in effect any requirement--

`(1) that relates to the regulation of a drug intended for use by humans (including a vaccine or other biological product); and

`(2) that is different from or in addition to, or that is otherwise not identical with, a requirement of this Act, section 351 of the Public Health Service Act (42 U.S.C. 262), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and the administrative implementation of such Acts.

`(b) REQUIREMENT RELATING TO REGULATIONS- For purposes of this section, a requirement relating to the regulation of a drug, vaccine, or other biological product shall be deemed to include any requirement relating to the subject matter in any provision of this Act, section 351 of the Public Health Service Act (42 U.S.C. 262), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), but shall not include any requirement relating to the practice of pharmacy or any requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.


`(a) IN GENERAL- Except as provided in this section, no State or political subdivision of a State may, directly or indirectly, establish or continue in effect under any authority any notification requirement for a drug, vaccine, or other biological product intended for use by humans that provides for a warning concerning the safety of the drug, vaccine, or biological product or any component or package thereof, unless such notification requirement has been prescribed under the authority of this Act and the State or political subdivision notification requirement is identical to the notification requirement prescribed under the authority of this Act.

`(b) DEFINITIONS- In this section:

`(1) NOTIFICATION REQUIREMENT- The term `notification requirement' includes any mandatory disclosure requirement relating to the dissemination of information about a drug, vaccine, or biological product in any manner, such as labels, labeling, posters, public notices, advertising, or any other means of communication.

`(2) WARNING- The term `warning' with respect to a drug, vaccine, or other biological product means any statement, vignette, or other representation which indicates, directly or by implication, that the drug, vaccine or biological product presents or may present a hazard to human health or safety.


`Upon application of a State, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from section 761 or 762, under such conditions as the Secretary may impose, a State requirement that--

`(1) is justified by compelling and unique local conditions;

`(2) protects an important public interest that would otherwise be unprotected;

`(3) would not cause any drug, vaccine, or other biological product to be in violation of any applicable requirement or prohibition under Federal law; and

`(4) would not unduly burden interstate commerce.'.

Subtitle B--Litigation Reform